The claimed invention is the focus of the assessment of whether an applicant has satisfied the utility requirement. Each claim (i.e., each “invention”), therefore, must be evaluated on its own merits for compliance with all statutory requirements. Generally speaking, however, a dependent claim will define an invention that has utility if the independent claim from which the dependent claim depends is drawn to the same statutory class of invention as the dependent claim and the independent claim defines an invention having utility. An exception to this general rule is where the utility specified for the invention defined in a dependent claim differs from that indicated for the invention defined in the independent claim from which the dependent claim depends. Where an applicant has established utility for a species that falls within an identified genus of compounds, and presents a generic claim covering the genus, as a general matter, that claim should be treated as being sufficient under 35 U.S.C. 101. Only where it can be established that other species clearly encompassed by the claim do not have utility should a rejection be imposed on the generic claim. In such cases, the applicant should be encouraged to amend the generic claim so as to exclude the species that lack utility.

The claimed invention is the focus of the assessment of whether an applicant has satisfied the utility requirement. Each claim (i.e., each “invention”), therefore, must be evaluated on its own merits for compliance with all statutory requirements. Generally speaking, however, a dependent claim will define an invention that has utility if the independent claim from which the dependent claim depends is drawn to the same statutory class of invention as the dependent claim and the independent claim defines an invention having utility. An exception to this general rule is where the utility specified for the invention defined in a dependent claim differs from that indicated for the invention defined in the independent claim from which the dependent claim depends. Where an applicant has established utility for a species that falls within an identified genus of compounds, and presents a generic claim covering the genus, as a general matter, that claim should be treated as being sufficient under 35 U.S.C. 101. Only where it can be established that other species clearly encompassed by the claim do not have utility should a rejection be imposed on the generic claim. In such cases, the applicant should be encouraged to amend the generic claim so as to exclude the species that lack utility.

The claimed invention is the focus of the assessment of whether an applicant has satisfied the utility requirement. Each claim (i.e., each “invention”), therefore, must be evaluated on its own merits for compliance with all statutory requirements. Generally speaking, however, a dependent claim will define an invention that has utility if the independent claim from which the dependent claim depends is drawn to the same statutory class of invention as the dependent claim and the independent claim defines an invention having utility. An exception to this general rule is where the utility specified for the invention defined in a dependent claim differs from that indicated for the invention defined in the independent claim from which the dependent claim depends. Where an applicant has established utility for a species that falls within an identified genus of compounds, and presents a generic claim covering the genus, as a general matter, that claim should be treated as being sufficient under 35 U.S.C. 101. Only where it can be established that other species clearly encompassed by the claim do not have utility should a rejection be imposed on the generic claim. In such cases, the applicant should be encouraged to amend the generic claim so as to exclude the species that lack utility.

The claimed invention is the focus of the assessment of whether an applicant has satisfied the utility requirement. Each claim (i.e., each “invention”), therefore, must be evaluated on its own merits for compliance with all statutory requirements. Generally speaking, however, a dependent claim will define an invention that has utility if the independent claim from which the dependent claim depends is drawn to the same statutory class of invention as the dependent claim and the independent claim defines an invention having utility. An exception to this general rule is where the utility specified for the invention defined in a dependent claim differs from that indicated for the invention defined in the independent claim from which the dependent claim depends. Where an applicant has established utility for a species that falls within an identified genus of compounds, and presents a generic claim covering the genus, as a general matter, that claim should be treated as being sufficient under 35 U.S.C. 101. Only where it can be established that other species clearly encompassed by the claim do not have utility should a rejection be imposed on the generic claim. In such cases, the applicant should be encouraged to amend the generic claim so as to exclude the species that lack utility.

The claimed invention is the focus of the assessment of whether an applicant has satisfied the utility requirement. Each claim (i.e., each “invention”), therefore, must be evaluated on its own merits for compliance with all statutory requirements. Generally speaking, however, a dependent claim will define an invention that has utility if the independent claim from which the dependent claim depends is drawn to the same statutory class of invention as the dependent claim and the independent claim defines an invention having utility. An exception to this general rule is where the utility specified for the invention defined in a dependent claim differs from that indicated for the invention defined in the independent claim from which the dependent claim depends. Where an applicant has established utility for a species that falls within an identified genus of compounds, and presents a generic claim covering the genus, as a general matter, that claim should be treated as being sufficient under 35 U.S.C. 101. Only where it can be established that other species clearly encompassed by the claim do not have utility should a rejection be imposed on the generic claim. In such cases, the applicant should be encouraged to amend the generic claim so as to exclude the species that lack utility.

The claimed invention is the focus of the assessment of whether an applicant has satisfied the utility requirement. Each claim (i.e., each “invention”), therefore, must be evaluated on its own merits for compliance with all statutory requirements. Generally speaking, however, a dependent claim will define an invention that has utility if the independent claim from which the dependent claim depends is drawn to the same statutory class of invention as the dependent claim and the independent claim defines an invention having utility. An exception to this general rule is where the utility specified for the invention defined in a dependent claim differs from that indicated for the invention defined in the independent claim from which the dependent claim depends. Where an applicant has established utility for a species that falls within an identified genus of compounds, and presents a generic claim covering the genus, as a general matter, that claim should be treated as being sufficient under 35 U.S.C. 101. Only where it can be established that other species clearly encompassed by the claim do not have utility should a rejection be imposed on the generic claim. In such cases, the applicant should be encouraged to amend the generic claim so as to exclude the species that lack utility.

Occasionally, an applicant will not explicitly state in the specification or otherwise assert a specific and substantial utility for the claimed invention. If no statements can be found asserting a specific and substantial utility for the claimed invention in the specification, Office personnel should determine if the claimed invention has a well-established utility. An invention has a well-established utility if (i) a person of ordinary skill in the art would immediately appreciate why the invention is useful based on the characteristics of the invention (e.g., properties or applications of a product or process), and (ii) the utility is specific, substantial, and credible. If an invention has a well- established utility, rejections under 35 U.S.C. 101 and 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, based on lack of utility should not be imposed. In re Folkers, 344 F.2d 970, 145 USPQ 390 (CCPA 1965). For example, if an application teaches the cloning and characterization of the nucleotide sequence of a well-known protein such as insulin, and those skilled in the art at the time of filing knew that insulin had a well-established use, it would be improper to reject the claimed invention as lacking utility solely because of the omitted statement of specific and substantial utility.

In most cases, an applicant’s assertion of utility creates a presumption of utility that will be sufficient to satisfy the utility requirement of 35 U.S.C. 101. See, e.g., In re Jolles, 628 F.2d 1322, 206 USPQ 885 (CCPA 1980); In re Irons, 340 F.2d 974, 144 USPQ 351 (CCPA 1965); In re Langer, 503 F.2d 1380, 183 USPQ 288 (CCPA 1974); In re Sichert, 566 F.2d 1154, 1159, 196 USPQ 209, 212-13 (CCPA 1977). As the Court of Customs and Patent Appeals stated in In re Langer:

In most cases, an applicant’s assertion of utility creates a presumption of utility that will be sufficient to satisfy the utility requirement of 35 U.S.C. 101. See, e.g., In re Jolles, 628 F.2d 1322, 206 USPQ 885 (CCPA 1980); In re Irons, 340 F.2d 974, 144 USPQ 351 (CCPA 1965); In re Langer, 503 F.2d 1380, 183 USPQ 288 (CCPA 1974); In re Sichert, 566 F.2d 1154, 1159, 196 USPQ 209, 212-13 (CCPA 1977). As the Court of Customs and Patent Appeals stated in In re Langer:

In most cases, an applicant’s assertion of utility creates a presumption of utility that will be sufficient to satisfy the utility requirement of 35 U.S.C. 101. See, e.g., In re Jolles, 628 F.2d 1322, 206 USPQ 885 (CCPA 1980); In re Irons, 340 F.2d 974, 144 USPQ 351 (CCPA 1965); In re Langer, 503 F.2d 1380, 183 USPQ 288 (CCPA 1974); In re Sichert, 566 F.2d 1154, 1159, 196 USPQ 209, 212-13 (CCPA 1977). As the Court of Customs and Patent Appeals stated in In re Langer:

In re Langer, 503 F.2d at 1391, 183 USPQ at 297 (emphasis in original). The “Langer” test for utility has been used by both the Federal Circuit and the Court of Customs and Patent Appeals in evaluation of rejections under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, where the rejection is based on a deficiency under 35 U.S.C. 101. In In re Brana, 51 F.3d 1560, 34 USPQ2d 1436 (Fed. Cir. 1995), the Federal Circuit explicitly adopted the Court of Customs and Patent Appeals formulation of the “Langer” standard for 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph rejections, as it was expressed in a slightly reworded format in In re Marzocchi, 439 F.2d 220, 223, 169 USPQ 367, 369 (CCPA 1971), namely:

In re Langer, 503 F.2d at 1391, 183 USPQ at 297 (emphasis in original). The “Langer” test for utility has been used by both the Federal Circuit and the Court of Customs and Patent Appeals in evaluation of rejections under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, where the rejection is based on a deficiency under 35 U.S.C. 101. In In re Brana, 51 F.3d 1560, 34 USPQ2d 1436 (Fed. Cir. 1995), the Federal Circuit explicitly adopted the Court of Customs and Patent Appeals formulation of the “Langer” standard for 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph rejections, as it was expressed in a slightly reworded format in In re Marzocchi, 439 F.2d 220, 223, 169 USPQ 367, 369 (CCPA 1971), namely:

One situation where an assertion of utility would not be considered credible is where a person of ordinary skill would consider the assertion to be “incredible in view of contemporary knowledge” and where nothing offered by the applicant would counter what contemporary knowledge might otherwise suggest. Office personnel should be careful, however, not to label certain types of inventions as “incredible” or “speculative” as such labels do not provide the correct focus for the evaluation of an assertion of utility. “Incredible utility” is a conclusion, not a starting point for analysis under 35 U.S.C. 101. A conclusion that an asserted utility is incredible can be reached only after the Office has evaluated both the assertion of the applicant regarding utility and any evidentiary basis of that assertion. The Office should be particularly careful not to start with a presumption that an asserted utility is, per se, “incredible” and then proceed to base a rejection under 35 U.S.C. 101 on that presumption.

One situation where an assertion of utility would not be considered credible is where a person of ordinary skill would consider the assertion to be “incredible in view of contemporary knowledge” and where nothing offered by the applicant would counter what contemporary knowledge might otherwise suggest. Office personnel should be careful, however, not to label certain types of inventions as “incredible” or “speculative” as such labels do not provide the correct focus for the evaluation of an assertion of utility. “Incredible utility” is a conclusion, not a starting point for analysis under 35 U.S.C. 101. A conclusion that an asserted utility is incredible can be reached only after the Office has evaluated both the assertion of the applicant regarding utility and any evidentiary basis of that assertion. The Office should be particularly careful not to start with a presumption that an asserted utility is, per se, “incredible” and then proceed to base a rejection under 35 U.S.C. 101 on that presumption.

One situation where an assertion of utility would not be considered credible is where a person of ordinary skill would consider the assertion to be “incredible in view of contemporary knowledge” and where nothing offered by the applicant would counter what contemporary knowledge might otherwise suggest. Office personnel should be careful, however, not to label certain types of inventions as “incredible” or “speculative” as such labels do not provide the correct focus for the evaluation of an assertion of utility. “Incredible utility” is a conclusion, not a starting point for analysis under 35 U.S.C. 101. A conclusion that an asserted utility is incredible can be reached only after the Office has evaluated both the assertion of the applicant regarding utility and any evidentiary basis of that assertion. The Office should be particularly careful not to start with a presumption that an asserted utility is, per se, “incredible” and then proceed to base a rejection under 35 U.S.C. 101 on that presumption.

Rejections under 35 U.S.C. 101 based on a lack of credible utility have been sustained by federal courts when, for example, the applicant failed to disclose any utility for the invention or asserted a utility that could only be true if it violated a scientific principle, such as the second law of thermodynamics, or a law of nature, or was wholly inconsistent with contemporary knowledge in the art. In re Gazave, 379 F.2d 973, 978, 154 USPQ 92, 96 (CCPA 1967). Special care should be taken when assessing the credibility of an asserted therapeutic utility for a claimed invention. In such cases, a previous lack of success in treating a disease or condition, or the absence of a proven animal model for testing the effectiveness of drugs for treating a disorder in humans, should not, standing alone, serve as a basis for challenging the asserted utility under 35 U.S.C. 101. See MPEP § 2107.03 for additional guidance with regard to therapeutic or pharmacological utilities.

Rejections under 35 U.S.C. 101 based on a lack of credible utility have been sustained by federal courts when, for example, the applicant failed to disclose any utility for the invention or asserted a utility that could only be true if it violated a scientific principle, such as the second law of thermodynamics, or a law of nature, or was wholly inconsistent with contemporary knowledge in the art. In re Gazave, 379 F.2d 973, 978, 154 USPQ 92, 96 (CCPA 1967). Special care should be taken when assessing the credibility of an asserted therapeutic utility for a claimed invention. In such cases, a previous lack of success in treating a disease or condition, or the absence of a proven animal model for testing the effectiveness of drugs for treating a disorder in humans, should not, standing alone, serve as a basis for challenging the asserted utility under 35 U.S.C. 101. See MPEP § 2107.03 for additional guidance with regard to therapeutic or pharmacological utilities.

Use form paragraphs 7.04.01 and 7.05.02 through 7.05.04 to reject claims under 35 U.S.C. 101 for failure to satisfy the utility requirement.

Situations where an applicant either fails to indicate why an invention is considered useful, or where the applicant inaccurately describes the utility should rarely arise. One reason for this is that applicants are required to disclose the best mode known to them of practicing the invention at the time they file their application. An applicant who omits a description of the specific and substantial utility of the invention, or who incompletely describes that utility, may encounter problems with respect to the best mode requirement of 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph.

Situations where an applicant either fails to indicate why an invention is considered useful, or where the applicant inaccurately describes the utility should rarely arise. One reason for this is that applicants are required to disclose the best mode known to them of practicing the invention at the time they file their application. An applicant who omits a description of the specific and substantial utility of the invention, or who incompletely describes that utility, may encounter problems with respect to the best mode requirement of 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph.

If a person of ordinary skill would not immediately recognize a specific and substantial utility for the claimed invention (i.e., why it would be useful) based on the characteristics of the invention or statements made by the applicant, the examiner should reject the application under 35 U.S.C. 101 and under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, as failing to identify a specific and substantial utility for the claimed invention. The rejection should clearly indicate that the basis of the rejection is that the application fails to identify a specific and substantial utility for the invention. The rejection should also specify that the applicant must reply by indicating why the invention is believed useful and where support for any subsequently asserted utility can be found in the specification as filed. See MPEP § 2701.

If a rejection under 35 U.S.C. 101 has been properly imposed, along with a corresponding rejection under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, the burden shifts to the applicant to rebut the prima facie showing. In re Oetiker, 977 F.2d 1443, 1445, 24 USPQ2d 1443, 1444 (Fed. Cir. 1992) (“The examiner bears the initial burden, on review of the prior art or on any other ground, of presenting a prima facie case of unpatentability. If that burden is met, the burden of coming forward with evidence or argument shifts to the applicant… After evidence or argument is submitted by the applicant in response, patentability is determined on the totality of the record, by a preponderance of evidence with due consideration to persuasiveness of argument.”). An applicant can do this using any combination of the following: amendments to the claims, arguments or reasoning, or new evidence submitted in an affidavit or declaration under 37 CFR 1.132, or in a printed publication. New evidence provided by an applicant must be relevant to the issues raised in the rejection. For example, declarations in which conclusions are set forth without establishing a nexus between those conclusions and the supporting evidence, or which merely express opinions, may be of limited probative value with regard to rebutting a prima facie case. In re Grunwell, 609 F.2d 486, 203 USPQ 1055 (CCPA 1979); In re Buchner, 929 F.2d 660, 18 USPQ2d 1331 (Fed. Cir. 1991). See MPEP § 716.01(a) through MPEP § 716.01(c).

If a rejection under 35 U.S.C. 101 has been properly imposed, along with a corresponding rejection under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, the burden shifts to the applicant to rebut the prima facie showing. In re Oetiker, 977 F.2d 1443, 1445, 24 USPQ2d 1443, 1444 (Fed. Cir. 1992) (“The examiner bears the initial burden, on review of the prior art or on any other ground, of presenting a prima facie case of unpatentability. If that burden is met, the burden of coming forward with evidence or argument shifts to the applicant… After evidence or argument is submitted by the applicant in response, patentability is determined on the totality of the record, by a preponderance of evidence with due consideration to persuasiveness of argument.”). An applicant can do this using any combination of the following: amendments to the claims, arguments or reasoning, or new evidence submitted in an affidavit or declaration under 37 CFR 1.132, or in a printed publication. New evidence provided by an applicant must be relevant to the issues raised in the rejection. For example, declarations in which conclusions are set forth without establishing a nexus between those conclusions and the supporting evidence, or which merely express opinions, may be of limited probative value with regard to rebutting a prima facie case. In re Grunwell, 609 F.2d 486, 203 USPQ 1055 (CCPA 1979); In re Buchner, 929 F.2d 660, 18 USPQ2d 1331 (Fed. Cir. 1991). See MPEP § 716.01(a) through MPEP § 716.01(c).

If a rejection under 35 U.S.C. 101 has been properly imposed, along with a corresponding rejection under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, the burden shifts to the applicant to rebut the prima facie showing. In re Oetiker, 977 F.2d 1443, 1445, 24 USPQ2d 1443, 1444 (Fed. Cir. 1992) (“The examiner bears the initial burden, on review of the prior art or on any other ground, of presenting a prima facie case of unpatentability. If that burden is met, the burden of coming forward with evidence or argument shifts to the applicant… After evidence or argument is submitted by the applicant in response, patentability is determined on the totality of the record, by a preponderance of evidence with due consideration to persuasiveness of argument.”). An applicant can do this using any combination of the following: amendments to the claims, arguments or reasoning, or new evidence submitted in an affidavit or declaration under 37 CFR 1.132, or in a printed publication. New evidence provided by an applicant must be relevant to the issues raised in the rejection. For example, declarations in which conclusions are set forth without establishing a nexus between those conclusions and the supporting evidence, or which merely express opinions, may be of limited probative value with regard to rebutting a prima facie case. In re Grunwell, 609 F.2d 486, 203 USPQ 1055 (CCPA 1979); In re Buchner, 929 F.2d 660, 18 USPQ2d 1331 (Fed. Cir. 1991). See MPEP § 716.01(a) through MPEP § 716.01(c).

If a rejection under 35 U.S.C. 101 has been properly imposed, along with a corresponding rejection under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, the burden shifts to the applicant to rebut the prima facie showing. In re Oetiker, 977 F.2d 1443, 1445, 24 USPQ2d 1443, 1444 (Fed. Cir. 1992) (“The examiner bears the initial burden, on review of the prior art or on any other ground, of presenting a prima facie case of unpatentability. If that burden is met, the burden of coming forward with evidence or argument shifts to the applicant… After evidence or argument is submitted by the applicant in response, patentability is determined on the totality of the record, by a preponderance of evidence with due consideration to persuasiveness of argument.”). An applicant can do this using any combination of the following: amendments to the claims, arguments or reasoning, or new evidence submitted in an affidavit or declaration under 37 CFR 1.132, or in a printed publication. New evidence provided by an applicant must be relevant to the issues raised in the rejection. For example, declarations in which conclusions are set forth without establishing a nexus between those conclusions and the supporting evidence, or which merely express opinions, may be of limited probative value with regard to rebutting a prima facie case. In re Grunwell, 609 F.2d 486, 203 USPQ 1055 (CCPA 1979); In re Buchner, 929 F.2d 660, 18 USPQ2d 1331 (Fed. Cir. 1991). See MPEP § 716.01(a) through MPEP § 716.01(c).

If a rejection under 35 U.S.C. 101 has been properly imposed, along with a corresponding rejection under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, the burden shifts to the applicant to rebut the prima facie showing. In re Oetiker, 977 F.2d 1443, 1445, 24 USPQ2d 1443, 1444 (Fed. Cir. 1992) (“The examiner bears the initial burden, on review of the prior art or on any other ground, of presenting a prima facie case of unpatentability. If that burden is met, the burden of coming forward with evidence or argument shifts to the applicant… After evidence or argument is submitted by the applicant in response, patentability is determined on the totality of the record, by a preponderance of evidence with due consideration to persuasiveness of argument.”). An applicant can do this using any combination of the following: amendments to the claims, arguments or reasoning, or new evidence submitted in an affidavit or declaration under 37 CFR 1.132, or in a printed publication. New evidence provided by an applicant must be relevant to the issues raised in the rejection. For example, declarations in which conclusions are set forth without establishing a nexus between those conclusions and the supporting evidence, or which merely express opinions, may be of limited probative value with regard to rebutting a prima facie case. In re Grunwell, 609 F.2d 486, 203 USPQ 1055 (CCPA 1979); In re Buchner, 929 F.2d 660, 18 USPQ2d 1331 (Fed. Cir. 1991). See MPEP § 716.01(a) through MPEP § 716.01(c).

In appropriate situations the Office may require an applicant to substantiate an asserted utility for a claimed invention. See In re Pottier, 376 F.2d 328, 330, 153 USPQ 407, 408 (CCPA 1967) (“When the operativeness of any process would be deemed unlikely by one of ordinary skill in the art, it is not improper for the examiner to call for evidence of operativeness.”). See also In re Jolles, 628 F.2d 1322, 1327, 206 USPQ 885, 890 (CCPA 1980); In re Citron, 325 F.2d 248, 139 USPQ 516 (CCPA 1963); In re Novak, 306 F.2d 924, 928, 134 USPQ 335, 337 (CCPA1962). In In re Citron, the court held that when an “alleged utility appears to be incredible in the light of the knowledge of the art, or factually misleading, applicant must establish the asserted utility by acceptable proof.” 325 F.2d at 253, 139 USPQ at 520. The court approved of the board’s decision which affirmed the rejection under 35 U.S.C. 101 “ in view of the art knowledge of the lack of a cure for cancer and the absence of any clinical data to substantiate the allegation.” 325 F.2d at 252, 139 USPQ at 519 (emphasis in original). The court thus established a higher burden on the applicant where the statement of use is incredible or misleading. In such a case, the examiner should challenge the use and require sufficient evidence of operativeness. The purpose of this authority is to enable an applicant to cure an otherwise defective factual basis for the operability of an invention. Because this is a curative authority (e.g., evidence is requested to enable an applicant to support an assertion that is inconsistent with the facts of record in the application), Office personnel should indicate not only why the factual record is defective in relation to the assertions of the applicant, but also, where appropriate, what type of evidentiary showing can be provided by the applicant to remedy the problem.

In appropriate situations the Office may require an applicant to substantiate an asserted utility for a claimed invention. See In re Pottier, 376 F.2d 328, 330, 153 USPQ 407, 408 (CCPA 1967) (“When the operativeness of any process would be deemed unlikely by one of ordinary skill in the art, it is not improper for the examiner to call for evidence of operativeness.”). See also In re Jolles, 628 F.2d 1322, 1327, 206 USPQ 885, 890 (CCPA 1980); In re Citron, 325 F.2d 248, 139 USPQ 516 (CCPA 1963); In re Novak, 306 F.2d 924, 928, 134 USPQ 335, 337 (CCPA1962). In In re Citron, the court held that when an “alleged utility appears to be incredible in the light of the knowledge of the art, or factually misleading, applicant must establish the asserted utility by acceptable proof.” 325 F.2d at 253, 139 USPQ at 520. The court approved of the board’s decision which affirmed the rejection under 35 U.S.C. 101 “ in view of the art knowledge of the lack of a cure for cancer and the absence of any clinical data to substantiate the allegation.” 325 F.2d at 252, 139 USPQ at 519 (emphasis in original). The court thus established a higher burden on the applicant where the statement of use is incredible or misleading. In such a case, the examiner should challenge the use and require sufficient evidence of operativeness. The purpose of this authority is to enable an applicant to cure an otherwise defective factual basis for the operability of an invention. Because this is a curative authority (e.g., evidence is requested to enable an applicant to support an assertion that is inconsistent with the facts of record in the application), Office personnel should indicate not only why the factual record is defective in relation to the assertions of the applicant, but also, where appropriate, what type of evidentiary showing can be provided by the applicant to remedy the problem.

In appropriate situations the Office may require an applicant to substantiate an asserted utility for a claimed invention. See In re Pottier, 376 F.2d 328, 330, 153 USPQ 407, 408 (CCPA 1967) (“When the operativeness of any process would be deemed unlikely by one of ordinary skill in the art, it is not improper for the examiner to call for evidence of operativeness.”). See also In re Jolles, 628 F.2d 1322, 1327, 206 USPQ 885, 890 (CCPA 1980); In re Citron, 325 F.2d 248, 139 USPQ 516 (CCPA 1963); In re Novak, 306 F.2d 924, 928, 134 USPQ 335, 337 (CCPA1962). In In re Citron, the court held that when an “alleged utility appears to be incredible in the light of the knowledge of the art, or factually misleading, applicant must establish the asserted utility by acceptable proof.” 325 F.2d at 253, 139 USPQ at 520. The court approved of the board’s decision which affirmed the rejection under 35 U.S.C. 101 “ in view of the art knowledge of the lack of a cure for cancer and the absence of any clinical data to substantiate the allegation.” 325 F.2d at 252, 139 USPQ at 519 (emphasis in original). The court thus established a higher burden on the applicant where the statement of use is incredible or misleading. In such a case, the examiner should challenge the use and require sufficient evidence of operativeness. The purpose of this authority is to enable an applicant to cure an otherwise defective factual basis for the operability of an invention. Because this is a curative authority (e.g., evidence is requested to enable an applicant to support an assertion that is inconsistent with the facts of record in the application), Office personnel should indicate not only why the factual record is defective in relation to the assertions of the applicant, but also, where appropriate, what type of evidentiary showing can be provided by the applicant to remedy the problem.

In appropriate situations the Office may require an applicant to substantiate an asserted utility for a claimed invention. See In re Pottier, 376 F.2d 328, 330, 153 USPQ 407, 408 (CCPA 1967) (“When the operativeness of any process would be deemed unlikely by one of ordinary skill in the art, it is not improper for the examiner to call for evidence of operativeness.”). See also In re Jolles, 628 F.2d 1322, 1327, 206 USPQ 885, 890 (CCPA 1980); In re Citron, 325 F.2d 248, 139 USPQ 516 (CCPA 1963); In re Novak, 306 F.2d 924, 928, 134 USPQ 335, 337 (CCPA1962). In In re Citron, the court held that when an “alleged utility appears to be incredible in the light of the knowledge of the art, or factually misleading, applicant must establish the asserted utility by acceptable proof.” 325 F.2d at 253, 139 USPQ at 520. The court approved of the board’s decision which affirmed the rejection under 35 U.S.C. 101 “ in view of the art knowledge of the lack of a cure for cancer and the absence of any clinical data to substantiate the allegation.” 325 F.2d at 252, 139 USPQ at 519 (emphasis in original). The court thus established a higher burden on the applicant where the statement of use is incredible or misleading. In such a case, the examiner should challenge the use and require sufficient evidence of operativeness. The purpose of this authority is to enable an applicant to cure an otherwise defective factual basis for the operability of an invention. Because this is a curative authority (e.g., evidence is requested to enable an applicant to support an assertion that is inconsistent with the facts of record in the application), Office personnel should indicate not only why the factual record is defective in relation to the assertions of the applicant, but also, where appropriate, what type of evidentiary showing can be provided by the applicant to remedy the problem.

In appropriate situations the Office may require an applicant to substantiate an asserted utility for a claimed invention. See In re Pottier, 376 F.2d 328, 330, 153 USPQ 407, 408 (CCPA 1967) (“When the operativeness of any process would be deemed unlikely by one of ordinary skill in the art, it is not improper for the examiner to call for evidence of operativeness.”). See also In re Jolles, 628 F.2d 1322, 1327, 206 USPQ 885, 890 (CCPA 1980); In re Citron, 325 F.2d 248, 139 USPQ 516 (CCPA 1963); In re Novak, 306 F.2d 924, 928, 134 USPQ 335, 337 (CCPA1962). In In re Citron, the court held that when an “alleged utility appears to be incredible in the light of the knowledge of the art, or factually misleading, applicant must establish the asserted utility by acceptable proof.” 325 F.2d at 253, 139 USPQ at 520. The court approved of the board’s decision which affirmed the rejection under 35 U.S.C. 101 “ in view of the art knowledge of the lack of a cure for cancer and the absence of any clinical data to substantiate the allegation.” 325 F.2d at 252, 139 USPQ at 519 (emphasis in original). The court thus established a higher burden on the applicant where the statement of use is incredible or misleading. In such a case, the examiner should challenge the use and require sufficient evidence of operativeness. The purpose of this authority is to enable an applicant to cure an otherwise defective factual basis for the operability of an invention. Because this is a curative authority (e.g., evidence is requested to enable an applicant to support an assertion that is inconsistent with the facts of record in the application), Office personnel should indicate not only why the factual record is defective in relation to the assertions of the applicant, but also, where appropriate, what type of evidentiary showing can be provided by the applicant to remedy the problem.

In appropriate situations the Office may require an applicant to substantiate an asserted utility for a claimed invention. See In re Pottier, 376 F.2d 328, 330, 153 USPQ 407, 408 (CCPA 1967) (“When the operativeness of any process would be deemed unlikely by one of ordinary skill in the art, it is not improper for the examiner to call for evidence of operativeness.”). See also In re Jolles, 628 F.2d 1322, 1327, 206 USPQ 885, 890 (CCPA 1980); In re Citron, 325 F.2d 248, 139 USPQ 516 (CCPA 1963); In re Novak, 306 F.2d 924, 928, 134 USPQ 335, 337 (CCPA1962). In In re Citron, the court held that when an “alleged utility appears to be incredible in the light of the knowledge of the art, or factually misleading, applicant must establish the asserted utility by acceptable proof.” 325 F.2d at 253, 139 USPQ at 520. The court approved of the board’s decision which affirmed the rejection under 35 U.S.C. 101 “ in view of the art knowledge of the lack of a cure for cancer and the absence of any clinical data to substantiate the allegation.” 325 F.2d at 252, 139 USPQ at 519 (emphasis in original). The court thus established a higher burden on the applicant where the statement of use is incredible or misleading. In such a case, the examiner should challenge the use and require sufficient evidence of operativeness. The purpose of this authority is to enable an applicant to cure an otherwise defective factual basis for the operability of an invention. Because this is a curative authority (e.g., evidence is requested to enable an applicant to support an assertion that is inconsistent with the facts of record in the application), Office personnel should indicate not only why the factual record is defective in relation to the assertions of the applicant, but also, where appropriate, what type of evidentiary showing can be provided by the applicant to remedy the problem.

In appropriate situations the Office may require an applicant to substantiate an asserted utility for a claimed invention. See In re Pottier, 376 F.2d 328, 330, 153 USPQ 407, 408 (CCPA 1967) (“When the operativeness of any process would be deemed unlikely by one of ordinary skill in the art, it is not improper for the examiner to call for evidence of operativeness.”). See also In re Jolles, 628 F.2d 1322, 1327, 206 USPQ 885, 890 (CCPA 1980); In re Citron, 325 F.2d 248, 139 USPQ 516 (CCPA 1963); In re Novak, 306 F.2d 924, 928, 134 USPQ 335, 337 (CCPA1962). In In re Citron, the court held that when an “alleged utility appears to be incredible in the light of the knowledge of the art, or factually misleading, applicant must establish the asserted utility by acceptable proof.” 325 F.2d at 253, 139 USPQ at 520. The court approved of the board’s decision which affirmed the rejection under 35 U.S.C. 101 “ in view of the art knowledge of the lack of a cure for cancer and the absence of any clinical data to substantiate the allegation.” 325 F.2d at 252, 139 USPQ at 519 (emphasis in original). The court thus established a higher burden on the applicant where the statement of use is incredible or misleading. In such a case, the examiner should challenge the use and require sufficient evidence of operativeness. The purpose of this authority is to enable an applicant to cure an otherwise defective factual basis for the operability of an invention. Because this is a curative authority (e.g., evidence is requested to enable an applicant to support an assertion that is inconsistent with the facts of record in the application), Office personnel should indicate not only why the factual record is defective in relation to the assertions of the applicant, but also, where appropriate, what type of evidentiary showing can be provided by the applicant to remedy the problem.

In appropriate situations the Office may require an applicant to substantiate an asserted utility for a claimed invention. See In re Pottier, 376 F.2d 328, 330, 153 USPQ 407, 408 (CCPA 1967) (“When the operativeness of any process would be deemed unlikely by one of ordinary skill in the art, it is not improper for the examiner to call for evidence of operativeness.”). See also In re Jolles, 628 F.2d 1322, 1327, 206 USPQ 885, 890 (CCPA 1980); In re Citron, 325 F.2d 248, 139 USPQ 516 (CCPA 1963); In re Novak, 306 F.2d 924, 928, 134 USPQ 335, 337 (CCPA1962). In In re Citron, the court held that when an “alleged utility appears to be incredible in the light of the knowledge of the art, or factually misleading, applicant must establish the asserted utility by acceptable proof.” 325 F.2d at 253, 139 USPQ at 520. The court approved of the board’s decision which affirmed the rejection under 35 U.S.C. 101 “ in view of the art knowledge of the lack of a cure for cancer and the absence of any clinical data to substantiate the allegation.” 325 F.2d at 252, 139 USPQ at 519 (emphasis in original). The court thus established a higher burden on the applicant where the statement of use is incredible or misleading. In such a case, the examiner should challenge the use and require sufficient evidence of operativeness. The purpose of this authority is to enable an applicant to cure an otherwise defective factual basis for the operability of an invention. Because this is a curative authority (e.g., evidence is requested to enable an applicant to support an assertion that is inconsistent with the facts of record in the application), Office personnel should indicate not only why the factual record is defective in relation to the assertions of the applicant, but also, where appropriate, what type of evidentiary showing can be provided by the applicant to remedy the problem.

Except where an invention has a well-established utility, the failure of an applicant to specifically identify why an invention is believed to be useful renders the claimed invention deficient under 35 U.S.C. 101 and 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph. In such cases, the applicant has failed to identify a “specific and substantial utility” for the claimed invention. For example, a statement that a composition has an unspecified “biological activity” or that does not explain why a composition with that activity is believed to be useful fails to set forth a “specific and substantial utility.” Brenner v. Manson, 383 US 519, 148 USPQ 689 (1966) (general assertion of similarities to known compounds known to be useful without sufficient corresponding explanation why claimed compounds are believed to be similarly useful insufficient under 35 U.S.C. 101); In re Ziegler, 992 F.2d 1197, 1201, 26 USPQ2d 1600, 1604 (Fed. Cir. 1993) (disclosure that composition is “plastic-like” and can form “films” not sufficient to identify specific and substantial utility for invention); In re Kirk, 376 F.2d 936, 153 USPQ 48 (CCPA 1967) (indication that compound is “biologically active” or has “biological properties” insufficient standing alone). See also In re Joly, 376 F.2d 906, 153 USPQ 45 (CCPA 1967); Kawai v. Metlesics, 480 F.2d 880, 890, 178 USPQ 158, 165 (CCPA 1973) (contrasting description of invention as sedative which did suggest specific utility to general suggestion of “pharmacological effects on the central nervous system” which did not). In contrast, a disclosure that identifies a particular biological activity of a compound and explains how that activity can be utilized in a particular therapeutic application of the compound does contain an assertion of specific and substantial utility for the invention.

Except where an invention has a well-established utility, the failure of an applicant to specifically identify why an invention is believed to be useful renders the claimed invention deficient under 35 U.S.C. 101 and 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph. In such cases, the applicant has failed to identify a “specific and substantial utility” for the claimed invention. For example, a statement that a composition has an unspecified “biological activity” or that does not explain why a composition with that activity is believed to be useful fails to set forth a “specific and substantial utility.” Brenner v. Manson, 383 US 519, 148 USPQ 689 (1966) (general assertion of similarities to known compounds known to be useful without sufficient corresponding explanation why claimed compounds are believed to be similarly useful insufficient under 35 U.S.C. 101); In re Ziegler, 992 F.2d 1197, 1201, 26 USPQ2d 1600, 1604 (Fed. Cir. 1993) (disclosure that composition is “plastic-like” and can form “films” not sufficient to identify specific and substantial utility for invention); In re Kirk, 376 F.2d 936, 153 USPQ 48 (CCPA 1967) (indication that compound is “biologically active” or has “biological properties” insufficient standing alone). See also In re Joly, 376 F.2d 906, 153 USPQ 45 (CCPA 1967); Kawai v. Metlesics, 480 F.2d 880, 890, 178 USPQ 158, 165 (CCPA 1973) (contrasting description of invention as sedative which did suggest specific utility to general suggestion of “pharmacological effects on the central nervous system” which did not). In contrast, a disclosure that identifies a particular biological activity of a compound and explains how that activity can be utilized in a particular therapeutic application of the compound does contain an assertion of specific and substantial utility for the invention.

Occasionally, an applicant will not explicitly state in the specification or otherwise assert a specific and substantial utility for the claimed invention. If no statements can be found asserting a specific and substantial utility for the claimed invention in the specification, Office personnel should determine if the claimed invention has a well-established utility. An invention has a well-established utility if (i) a person of ordinary skill in the art would immediately appreciate why the invention is useful based on the characteristics of the invention (e.g., properties or applications of a product or process), and (ii) the utility is specific, substantial, and credible. If an invention has a well- established utility, rejections under 35 U.S.C. 101 and 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, based on lack of utility should not be imposed. In re Folkers, 344 F.2d 970, 145 USPQ 390 (CCPA 1965). For example, if an application teaches the cloning and characterization of the nucleotide sequence of a well-known protein such as insulin, and those skilled in the art at the time of filing knew that insulin had a well-established use, it would be improper to reject the claimed invention as lacking utility solely because of the omitted statement of specific and substantial utility.

Occasionally, an applicant will not explicitly state in the specification or otherwise assert a specific and substantial utility for the claimed invention. If no statements can be found asserting a specific and substantial utility for the claimed invention in the specification, Office personnel should determine if the claimed invention has a well-established utility. An invention has a well-established utility if (i) a person of ordinary skill in the art would immediately appreciate why the invention is useful based on the characteristics of the invention (e.g., properties or applications of a product or process), and (ii) the utility is specific, substantial, and credible. If an invention has a well- established utility, rejections under 35 U.S.C. 101 and 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, based on lack of utility should not be imposed. In re Folkers, 344 F.2d 970, 145 USPQ 390 (CCPA 1965). For example, if an application teaches the cloning and characterization of the nucleotide sequence of a well-known protein such as insulin, and those skilled in the art at the time of filing knew that insulin had a well-established use, it would be improper to reject the claimed invention as lacking utility solely because of the omitted statement of specific and substantial utility.

Occasionally, an applicant will not explicitly state in the specification or otherwise assert a specific and substantial utility for the claimed invention. If no statements can be found asserting a specific and substantial utility for the claimed invention in the specification, Office personnel should determine if the claimed invention has a well-established utility. An invention has a well-established utility if (i) a person of ordinary skill in the art would immediately appreciate why the invention is useful based on the characteristics of the invention (e.g., properties or applications of a product or process), and (ii) the utility is specific, substantial, and credible. If an invention has a well- established utility, rejections under 35 U.S.C. 101 and 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, based on lack of utility should not be imposed. In re Folkers, 344 F.2d 970, 145 USPQ 390 (CCPA 1965). For example, if an application teaches the cloning and characterization of the nucleotide sequence of a well-known protein such as insulin, and those skilled in the art at the time of filing knew that insulin had a well-established use, it would be improper to reject the claimed invention as lacking utility solely because of the omitted statement of specific and substantial utility.

If a person of ordinary skill would not immediately recognize a specific and substantial utility for the claimed invention (i.e., why it would be useful) based on the characteristics of the invention or statements made by the applicant, the examiner should reject the application under 35 U.S.C. 101 and under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, as failing to identify a specific and substantial utility for the claimed invention. The rejection should clearly indicate that the basis of the rejection is that the application fails to identify a specific and substantial utility for the invention. The rejection should also specify that the applicant must reply by indicating why the invention is believed useful and where support for any subsequently asserted utility can be found in the specification as filed. See MPEP § 2701.

Thus, Langer and subsequent cases direct the Office to presume that a statement of utility made by an applicant is true. See In re Langer, 503 F.2d at 1391, 183 USPQ at 297; In re Malachowski, 530 F.2d 1402, 1404, 189 USPQ 432, 435 (CCPA 1976); In re Brana, 51 F.3d 1560, 34 USPQ2d 1436 (Fed. Cir. 1995). For obvious reasons of efficiency and in deference to an applicant’s understanding of the invention, when a statement of utility is evaluated, Office personnel should not begin by questioning the truth of the statement of utility. Instead, any inquiry must start by asking if there is any reason to question the truth of the statement of utility. This can be done by simply evaluating the logic of the statements made, taking into consideration any evidence cited by the applicant. If the asserted utility is credible (i.e., believable based on the record or the nature of the invention), a rejection based on “lack of utility” is not appropriate. Clearly, Office personnel should not begin an evaluation of utility by assuming that an asserted utility is likely to be false, based on the technical field of the invention or for other general reasons.

Thus, Langer and subsequent cases direct the Office to presume that a statement of utility made by an applicant is true. See In re Langer, 503 F.2d at 1391, 183 USPQ at 297; In re Malachowski, 530 F.2d 1402, 1404, 189 USPQ 432, 435 (CCPA 1976); In re Brana, 51 F.3d 1560, 34 USPQ2d 1436 (Fed. Cir. 1995). For obvious reasons of efficiency and in deference to an applicant’s understanding of the invention, when a statement of utility is evaluated, Office personnel should not begin by questioning the truth of the statement of utility. Instead, any inquiry must start by asking if there is any reason to question the truth of the statement of utility. This can be done by simply evaluating the logic of the statements made, taking into consideration any evidence cited by the applicant. If the asserted utility is credible (i.e., believable based on the record or the nature of the invention), a rejection based on “lack of utility” is not appropriate. Clearly, Office personnel should not begin an evaluation of utility by assuming that an asserted utility is likely to be false, based on the technical field of the invention or for other general reasons.

Thus, Langer and subsequent cases direct the Office to presume that a statement of utility made by an applicant is true. See In re Langer, 503 F.2d at 1391, 183 USPQ at 297; In re Malachowski, 530 F.2d 1402, 1404, 189 USPQ 432, 435 (CCPA 1976); In re Brana, 51 F.3d 1560, 34 USPQ2d 1436 (Fed. Cir. 1995). For obvious reasons of efficiency and in deference to an applicant’s understanding of the invention, when a statement of utility is evaluated, Office personnel should not begin by questioning the truth of the statement of utility. Instead, any inquiry must start by asking if there is any reason to question the truth of the statement of utility. This can be done by simply evaluating the logic of the statements made, taking into consideration any evidence cited by the applicant. If the asserted utility is credible (i.e., believable based on the record or the nature of the invention), a rejection based on “lack of utility” is not appropriate. Clearly, Office personnel should not begin an evaluation of utility by assuming that an asserted utility is likely to be false, based on the technical field of the invention or for other general reasons.

Thus, Langer and subsequent cases direct the Office to presume that a statement of utility made by an applicant is true. See In re Langer, 503 F.2d at 1391, 183 USPQ at 297; In re Malachowski, 530 F.2d 1402, 1404, 189 USPQ 432, 435 (CCPA 1976); In re Brana, 51 F.3d 1560, 34 USPQ2d 1436 (Fed. Cir. 1995). For obvious reasons of efficiency and in deference to an applicant’s understanding of the invention, when a statement of utility is evaluated, Office personnel should not begin by questioning the truth of the statement of utility. Instead, any inquiry must start by asking if there is any reason to question the truth of the statement of utility. This can be done by simply evaluating the logic of the statements made, taking into consideration any evidence cited by the applicant. If the asserted utility is credible (i.e., believable based on the record or the nature of the invention), a rejection based on “lack of utility” is not appropriate. Clearly, Office personnel should not begin an evaluation of utility by assuming that an asserted utility is likely to be false, based on the technical field of the invention or for other general reasons.

Thus, Langer and subsequent cases direct the Office to presume that a statement of utility made by an applicant is true. See In re Langer, 503 F.2d at 1391, 183 USPQ at 297; In re Malachowski, 530 F.2d 1402, 1404, 189 USPQ 432, 435 (CCPA 1976); In re Brana, 51 F.3d 1560, 34 USPQ2d 1436 (Fed. Cir. 1995). For obvious reasons of efficiency and in deference to an applicant’s understanding of the invention, when a statement of utility is evaluated, Office personnel should not begin by questioning the truth of the statement of utility. Instead, any inquiry must start by asking if there is any reason to question the truth of the statement of utility. This can be done by simply evaluating the logic of the statements made, taking into consideration any evidence cited by the applicant. If the asserted utility is credible (i.e., believable based on the record or the nature of the invention), a rejection based on “lack of utility” is not appropriate. Clearly, Office personnel should not begin an evaluation of utility by assuming that an asserted utility is likely to be false, based on the technical field of the invention or for other general reasons.

Thus, Langer and subsequent cases direct the Office to presume that a statement of utility made by an applicant is true. See In re Langer, 503 F.2d at 1391, 183 USPQ at 297; In re Malachowski, 530 F.2d 1402, 1404, 189 USPQ 432, 435 (CCPA 1976); In re Brana, 51 F.3d 1560, 34 USPQ2d 1436 (Fed. Cir. 1995). For obvious reasons of efficiency and in deference to an applicant’s understanding of the invention, when a statement of utility is evaluated, Office personnel should not begin by questioning the truth of the statement of utility. Instead, any inquiry must start by asking if there is any reason to question the truth of the statement of utility. This can be done by simply evaluating the logic of the statements made, taking into consideration any evidence cited by the applicant. If the asserted utility is credible (i.e., believable based on the record or the nature of the invention), a rejection based on “lack of utility” is not appropriate. Clearly, Office personnel should not begin an evaluation of utility by assuming that an asserted utility is likely to be false, based on the technical field of the invention or for other general reasons.

Compliance with 35 U.S.C. 101 is a question of fact. Raytheon v. Roper, 724 F.2d 951, 956, 220 USPQ 592, 596 (Fed. Cir. 1983) cert. denied, 469 U.S. 835 (1984). Thus, to overcome the presumption of truth that an assertion of utility by the applicant enjoys, Office personnel must establish that it is more likely than not that one of ordinary skill in the art would doubt (i.e., “question”) the truth of the statement of utility. The evidentiary standard to be used throughout ex parte examination in setting forth a rejection is a preponderance of the totality of the evidence under consideration. In re Oetiker, 977 F.2d 1443, 1445, 24 USPQ2d 1443, 1444 (Fed. Cir. 1992) (“After evidence or argument is submitted by the applicant in response, patentability is determined on the totality of the record, by a preponderance of evidence with due consideration to persuasiveness of argument.”); In re Corkill, 771 F.2d 1496, 1500, 226 USPQ 1005, 1008 (Fed. Cir. 1985). A preponderance of the evidence exists when it suggests that it is more likely than not that the assertion in question is true. Herman v. Huddleston, 459 U.S. 375, 390 (1983). To do this, Office personnel must provide evidence sufficient to show that the statement of asserted utility would be considered “false” by a person of ordinary skill in the art. Of course, a person of ordinary skill must have the benefit of both facts and reasoning in order to assess the truth of a statement. This means that if the applicant has presented facts that support the reasoning used in asserting a utility, Office personnel must present countervailing facts and reasoning sufficient to establish that a person of ordinary skill would not believe the applicant’s assertion of utility. In re Brana, 51 F.3d 1560, 34 USPQ2d 1436 (Fed. Cir. 1995). The initial evidentiary standard used during evaluation of this question is a preponderance of the evidence (i.e., the totality of facts and reasoning suggest that it is more likely than not that the statement of the applicant is false).

Compliance with 35 U.S.C. 101 is a question of fact. Raytheon v. Roper, 724 F.2d 951, 956, 220 USPQ 592, 596 (Fed. Cir. 1983) cert. denied, 469 U.S. 835 (1984). Thus, to overcome the presumption of truth that an assertion of utility by the applicant enjoys, Office personnel must establish that it is more likely than not that one of ordinary skill in the art would doubt (i.e., “question”) the truth of the statement of utility. The evidentiary standard to be used throughout ex parte examination in setting forth a rejection is a preponderance of the totality of the evidence under consideration. In re Oetiker, 977 F.2d 1443, 1445, 24 USPQ2d 1443, 1444 (Fed. Cir. 1992) (“After evidence or argument is submitted by the applicant in response, patentability is determined on the totality of the record, by a preponderance of evidence with due consideration to persuasiveness of argument.”); In re Corkill, 771 F.2d 1496, 1500, 226 USPQ 1005, 1008 (Fed. Cir. 1985). A preponderance of the evidence exists when it suggests that it is more likely than not that the assertion in question is true. Herman v. Huddleston, 459 U.S. 375, 390 (1983). To do this, Office personnel must provide evidence sufficient to show that the statement of asserted utility would be considered “false” by a person of ordinary skill in the art. Of course, a person of ordinary skill must have the benefit of both facts and reasoning in order to assess the truth of a statement. This means that if the applicant has presented facts that support the reasoning used in asserting a utility, Office personnel must present countervailing facts and reasoning sufficient to establish that a person of ordinary skill would not believe the applicant’s assertion of utility. In re Brana, 51 F.3d 1560, 34 USPQ2d 1436 (Fed. Cir. 1995). The initial evidentiary standard used during evaluation of this question is a preponderance of the evidence (i.e., the totality of facts and reasoning suggest that it is more likely than not that the statement of the applicant is false).

Compliance with 35 U.S.C. 101 is a question of fact. Raytheon v. Roper, 724 F.2d 951, 956, 220 USPQ 592, 596 (Fed. Cir. 1983) cert. denied, 469 U.S. 835 (1984). Thus, to overcome the presumption of truth that an assertion of utility by the applicant enjoys, Office personnel must establish that it is more likely than not that one of ordinary skill in the art would doubt (i.e., “question”) the truth of the statement of utility. The evidentiary standard to be used throughout ex parte examination in setting forth a rejection is a preponderance of the totality of the evidence under consideration. In re Oetiker, 977 F.2d 1443, 1445, 24 USPQ2d 1443, 1444 (Fed. Cir. 1992) (“After evidence or argument is submitted by the applicant in response, patentability is determined on the totality of the record, by a preponderance of evidence with due consideration to persuasiveness of argument.”); In re Corkill, 771 F.2d 1496, 1500, 226 USPQ 1005, 1008 (Fed. Cir. 1985). A preponderance of the evidence exists when it suggests that it is more likely than not that the assertion in question is true. Herman v. Huddleston, 459 U.S. 375, 390 (1983). To do this, Office personnel must provide evidence sufficient to show that the statement of asserted utility would be considered “false” by a person of ordinary skill in the art. Of course, a person of ordinary skill must have the benefit of both facts and reasoning in order to assess the truth of a statement. This means that if the applicant has presented facts that support the reasoning used in asserting a utility, Office personnel must present countervailing facts and reasoning sufficient to establish that a person of ordinary skill would not believe the applicant’s assertion of utility. In re Brana, 51 F.3d 1560, 34 USPQ2d 1436 (Fed. Cir. 1995). The initial evidentiary standard used during evaluation of this question is a preponderance of the evidence (i.e., the totality of facts and reasoning suggest that it is more likely than not that the statement of the applicant is false).

Compliance with 35 U.S.C. 101 is a question of fact. Raytheon v. Roper, 724 F.2d 951, 956, 220 USPQ 592, 596 (Fed. Cir. 1983) cert. denied, 469 U.S. 835 (1984). Thus, to overcome the presumption of truth that an assertion of utility by the applicant enjoys, Office personnel must establish that it is more likely than not that one of ordinary skill in the art would doubt (i.e., “question”) the truth of the statement of utility. The evidentiary standard to be used throughout ex parte examination in setting forth a rejection is a preponderance of the totality of the evidence under consideration. In re Oetiker, 977 F.2d 1443, 1445, 24 USPQ2d 1443, 1444 (Fed. Cir. 1992) (“After evidence or argument is submitted by the applicant in response, patentability is determined on the totality of the record, by a preponderance of evidence with due consideration to persuasiveness of argument.”); In re Corkill, 771 F.2d 1496, 1500, 226 USPQ 1005, 1008 (Fed. Cir. 1985). A preponderance of the evidence exists when it suggests that it is more likely than not that the assertion in question is true. Herman v. Huddleston, 459 U.S. 375, 390 (1983). To do this, Office personnel must provide evidence sufficient to show that the statement of asserted utility would be considered “false” by a person of ordinary skill in the art. Of course, a person of ordinary skill must have the benefit of both facts and reasoning in order to assess the truth of a statement. This means that if the applicant has presented facts that support the reasoning used in asserting a utility, Office personnel must present countervailing facts and reasoning sufficient to establish that a person of ordinary skill would not believe the applicant’s assertion of utility. In re Brana, 51 F.3d 1560, 34 USPQ2d 1436 (Fed. Cir. 1995). The initial evidentiary standard used during evaluation of this question is a preponderance of the evidence (i.e., the totality of facts and reasoning suggest that it is more likely than not that the statement of the applicant is false).

Compliance with 35 U.S.C. 101 is a question of fact. Raytheon v. Roper, 724 F.2d 951, 956, 220 USPQ 592, 596 (Fed. Cir. 1983) cert. denied, 469 U.S. 835 (1984). Thus, to overcome the presumption of truth that an assertion of utility by the applicant enjoys, Office personnel must establish that it is more likely than not that one of ordinary skill in the art would doubt (i.e., “question”) the truth of the statement of utility. The evidentiary standard to be used throughout ex parte examination in setting forth a rejection is a preponderance of the totality of the evidence under consideration. In re Oetiker, 977 F.2d 1443, 1445, 24 USPQ2d 1443, 1444 (Fed. Cir. 1992) (“After evidence or argument is submitted by the applicant in response, patentability is determined on the totality of the record, by a preponderance of evidence with due consideration to persuasiveness of argument.”); In re Corkill, 771 F.2d 1496, 1500, 226 USPQ 1005, 1008 (Fed. Cir. 1985). A preponderance of the evidence exists when it suggests that it is more likely than not that the assertion in question is true. Herman v. Huddleston, 459 U.S. 375, 390 (1983). To do this, Office personnel must provide evidence sufficient to show that the statement of asserted utility would be considered “false” by a person of ordinary skill in the art. Of course, a person of ordinary skill must have the benefit of both facts and reasoning in order to assess the truth of a statement. This means that if the applicant has presented facts that support the reasoning used in asserting a utility, Office personnel must present countervailing facts and reasoning sufficient to establish that a person of ordinary skill would not believe the applicant’s assertion of utility. In re Brana, 51 F.3d 1560, 34 USPQ2d 1436 (Fed. Cir. 1995). The initial evidentiary standard used during evaluation of this question is a preponderance of the evidence (i.e., the totality of facts and reasoning suggest that it is more likely than not that the statement of the applicant is false).

Compliance with 35 U.S.C. 101 is a question of fact. Raytheon v. Roper, 724 F.2d 951, 956, 220 USPQ 592, 596 (Fed. Cir. 1983) cert. denied, 469 U.S. 835 (1984). Thus, to overcome the presumption of truth that an assertion of utility by the applicant enjoys, Office personnel must establish that it is more likely than not that one of ordinary skill in the art would doubt (i.e., “question”) the truth of the statement of utility. The evidentiary standard to be used throughout ex parte examination in setting forth a rejection is a preponderance of the totality of the evidence under consideration. In re Oetiker, 977 F.2d 1443, 1445, 24 USPQ2d 1443, 1444 (Fed. Cir. 1992) (“After evidence or argument is submitted by the applicant in response, patentability is determined on the totality of the record, by a preponderance of evidence with due consideration to persuasiveness of argument.”); In re Corkill, 771 F.2d 1496, 1500, 226 USPQ 1005, 1008 (Fed. Cir. 1985). A preponderance of the evidence exists when it suggests that it is more likely than not that the assertion in question is true. Herman v. Huddleston, 459 U.S. 375, 390 (1983). To do this, Office personnel must provide evidence sufficient to show that the statement of asserted utility would be considered “false” by a person of ordinary skill in the art. Of course, a person of ordinary skill must have the benefit of both facts and reasoning in order to assess the truth of a statement. This means that if the applicant has presented facts that support the reasoning used in asserting a utility, Office personnel must present countervailing facts and reasoning sufficient to establish that a person of ordinary skill would not believe the applicant’s assertion of utility. In re Brana, 51 F.3d 1560, 34 USPQ2d 1436 (Fed. Cir. 1995). The initial evidentiary standard used during evaluation of this question is a preponderance of the evidence (i.e., the totality of facts and reasoning suggest that it is more likely than not that the statement of the applicant is false).

In appropriate situations the Office may require an applicant to substantiate an asserted utility for a claimed invention. See In re Pottier, 376 F.2d 328, 330, 153 USPQ 407, 408 (CCPA 1967) (“When the operativeness of any process would be deemed unlikely by one of ordinary skill in the art, it is not improper for the examiner to call for evidence of operativeness.”). See also In re Jolles, 628 F.2d 1322, 1327, 206 USPQ 885, 890 (CCPA 1980); In re Citron, 325 F.2d 248, 139 USPQ 516 (CCPA 1963); In re Novak, 306 F.2d 924, 928, 134 USPQ 335, 337 (CCPA1962). In In re Citron, the court held that when an “alleged utility appears to be incredible in the light of the knowledge of the art, or factually misleading, applicant must establish the asserted utility by acceptable proof.” 325 F.2d at 253, 139 USPQ at 520. The court approved of the board’s decision which affirmed the rejection under 35 U.S.C. 101 “ in view of the art knowledge of the lack of a cure for cancer and the absence of any clinical data to substantiate the allegation.” 325 F.2d at 252, 139 USPQ at 519 (emphasis in original). The court thus established a higher burden on the applicant where the statement of use is incredible or misleading. In such a case, the examiner should challenge the use and require sufficient evidence of operativeness. The purpose of this authority is to enable an applicant to cure an otherwise defective factual basis for the operability of an invention. Because this is a curative authority (e.g., evidence is requested to enable an applicant to support an assertion that is inconsistent with the facts of record in the application), Office personnel should indicate not only why the factual record is defective in relation to the assertions of the applicant, but also, where appropriate, what type of evidentiary showing can be provided by the applicant to remedy the problem.

There is no predetermined amount or character of evidence that must be provided by an applicant to support an asserted utility, therapeutic or otherwise. Rather, the character and amount of evidence needed to support an asserted utility will vary depending on what is claimed (Ex parte Ferguson, 117 USPQ 229 (Bd. App. 1957)), and whether the asserted utility appears to contravene established scientific principles and beliefs. In re Gazave, 379 F.2d 973, 978, 154 USPQ 92, 96 (CCPA 1967); In re Chilowsky, 229 F.2d 457, 462, 108 USPQ 321, 325 (CCPA 1956). Furthermore, the applicant does not have to provide evidence sufficient to establish that an asserted utility is true “beyond a reasonable doubt.” In re Irons, 340 F.2d 974, 978, 144 USPQ 351, 354 (CCPA 1965). Nor must an applicant provide evidence such that it establishes an asserted utility as a matter of statistical certainty. Nelson v. Bowler, 626 F.2d 853, 856-57, 206 USPQ 881, 883-84 (CCPA 1980) (reversing the Board and rejecting Bowler’s arguments that the evidence of utility was statistically insignificant. The court pointed out that a rigorous correlation is not necessary when the test is reasonably predictive of the response). See also Rey-Bellet v. Englehardt, 493 F.2d 1380, 181 USPQ 453 (CCPA 1974) (data from animal testing is relevant to asserted human therapeutic utility if there is a “satisfactory correlation between the effect on the animal and that ultimately observed in human beings”). Instead, evidence will be sufficient if, considered as a whole, it leads a person of ordinary skill in the art to conclude that the asserted utility is more likely than not true.

There is no predetermined amount or character of evidence that must be provided by an applicant to support an asserted utility, therapeutic or otherwise. Rather, the character and amount of evidence needed to support an asserted utility will vary depending on what is claimed (Ex parte Ferguson, 117 USPQ 229 (Bd. App. 1957)), and whether the asserted utility appears to contravene established scientific principles and beliefs. In re Gazave, 379 F.2d 973, 978, 154 USPQ 92, 96 (CCPA 1967); In re Chilowsky, 229 F.2d 457, 462, 108 USPQ 321, 325 (CCPA 1956). Furthermore, the applicant does not have to provide evidence sufficient to establish that an asserted utility is true “beyond a reasonable doubt.” In re Irons, 340 F.2d 974, 978, 144 USPQ 351, 354 (CCPA 1965). Nor must an applicant provide evidence such that it establishes an asserted utility as a matter of statistical certainty. Nelson v. Bowler, 626 F.2d 853, 856-57, 206 USPQ 881, 883-84 (CCPA 1980) (reversing the Board and rejecting Bowler’s arguments that the evidence of utility was statistically insignificant. The court pointed out that a rigorous correlation is not necessary when the test is reasonably predictive of the response). See also Rey-Bellet v. Englehardt, 493 F.2d 1380, 181 USPQ 453 (CCPA 1974) (data from animal testing is relevant to asserted human therapeutic utility if there is a “satisfactory correlation between the effect on the animal and that ultimately observed in human beings”). Instead, evidence will be sufficient if, considered as a whole, it leads a person of ordinary skill in the art to conclude that the asserted utility is more likely than not true.

There is no predetermined amount or character of evidence that must be provided by an applicant to support an asserted utility, therapeutic or otherwise. Rather, the character and amount of evidence needed to support an asserted utility will vary depending on what is claimed (Ex parte Ferguson, 117 USPQ 229 (Bd. App. 1957)), and whether the asserted utility appears to contravene established scientific principles and beliefs. In re Gazave, 379 F.2d 973, 978, 154 USPQ 92, 96 (CCPA 1967); In re Chilowsky, 229 F.2d 457, 462, 108 USPQ 321, 325 (CCPA 1956). Furthermore, the applicant does not have to provide evidence sufficient to establish that an asserted utility is true “beyond a reasonable doubt.” In re Irons, 340 F.2d 974, 978, 144 USPQ 351, 354 (CCPA 1965). Nor must an applicant provide evidence such that it establishes an asserted utility as a matter of statistical certainty. Nelson v. Bowler, 626 F.2d 853, 856-57, 206 USPQ 881, 883-84 (CCPA 1980) (reversing the Board and rejecting Bowler’s arguments that the evidence of utility was statistically insignificant. The court pointed out that a rigorous correlation is not necessary when the test is reasonably predictive of the response). See also Rey-Bellet v. Englehardt, 493 F.2d 1380, 181 USPQ 453 (CCPA 1974) (data from animal testing is relevant to asserted human therapeutic utility if there is a “satisfactory correlation between the effect on the animal and that ultimately observed in human beings”). Instead, evidence will be sufficient if, considered as a whole, it leads a person of ordinary skill in the art to conclude that the asserted utility is more likely than not true.

There is no predetermined amount or character of evidence that must be provided by an applicant to support an asserted utility, therapeutic or otherwise. Rather, the character and amount of evidence needed to support an asserted utility will vary depending on what is claimed (Ex parte Ferguson, 117 USPQ 229 (Bd. App. 1957)), and whether the asserted utility appears to contravene established scientific principles and beliefs. In re Gazave, 379 F.2d 973, 978, 154 USPQ 92, 96 (CCPA 1967); In re Chilowsky, 229 F.2d 457, 462, 108 USPQ 321, 325 (CCPA 1956). Furthermore, the applicant does not have to provide evidence sufficient to establish that an asserted utility is true “beyond a reasonable doubt.” In re Irons, 340 F.2d 974, 978, 144 USPQ 351, 354 (CCPA 1965). Nor must an applicant provide evidence such that it establishes an asserted utility as a matter of statistical certainty. Nelson v. Bowler, 626 F.2d 853, 856-57, 206 USPQ 881, 883-84 (CCPA 1980) (reversing the Board and rejecting Bowler’s arguments that the evidence of utility was statistically insignificant. The court pointed out that a rigorous correlation is not necessary when the test is reasonably predictive of the response). See also Rey-Bellet v. Englehardt, 493 F.2d 1380, 181 USPQ 453 (CCPA 1974) (data from animal testing is relevant to asserted human therapeutic utility if there is a “satisfactory correlation between the effect on the animal and that ultimately observed in human beings”). Instead, evidence will be sufficient if, considered as a whole, it leads a person of ordinary skill in the art to conclude that the asserted utility is more likely than not true.

There is no predetermined amount or character of evidence that must be provided by an applicant to support an asserted utility, therapeutic or otherwise. Rather, the character and amount of evidence needed to support an asserted utility will vary depending on what is claimed (Ex parte Ferguson, 117 USPQ 229 (Bd. App. 1957)), and whether the asserted utility appears to contravene established scientific principles and beliefs. In re Gazave, 379 F.2d 973, 978, 154 USPQ 92, 96 (CCPA 1967); In re Chilowsky, 229 F.2d 457, 462, 108 USPQ 321, 325 (CCPA 1956). Furthermore, the applicant does not have to provide evidence sufficient to establish that an asserted utility is true “beyond a reasonable doubt.” In re Irons, 340 F.2d 974, 978, 144 USPQ 351, 354 (CCPA 1965). Nor must an applicant provide evidence such that it establishes an asserted utility as a matter of statistical certainty. Nelson v. Bowler, 626 F.2d 853, 856-57, 206 USPQ 881, 883-84 (CCPA 1980) (reversing the Board and rejecting Bowler’s arguments that the evidence of utility was statistically insignificant. The court pointed out that a rigorous correlation is not necessary when the test is reasonably predictive of the response). See also Rey-Bellet v. Englehardt, 493 F.2d 1380, 181 USPQ 453 (CCPA 1974) (data from animal testing is relevant to asserted human therapeutic utility if there is a “satisfactory correlation between the effect on the animal and that ultimately observed in human beings”). Instead, evidence will be sufficient if, considered as a whole, it leads a person of ordinary skill in the art to conclude that the asserted utility is more likely than not true.

One situation where an assertion of utility would not be considered credible is where a person of ordinary skill would consider the assertion to be “incredible in view of contemporary knowledge” and where nothing offered by the applicant would counter what contemporary knowledge might otherwise suggest. Office personnel should be careful, however, not to label certain types of inventions as “incredible” or “speculative” as such labels do not provide the correct focus for the evaluation of an assertion of utility. “Incredible utility” is a conclusion, not a starting point for analysis under 35 U.S.C. 101. A conclusion that an asserted utility is incredible can be reached only after the Office has evaluated both the assertion of the applicant regarding utility and any evidentiary basis of that assertion. The Office should be particularly careful not to start with a presumption that an asserted utility is, per se, “incredible” and then proceed to base a rejection under 35 U.S.C. 101 on that presumption.

To properly reject a claimed invention under 35 U.S.C. 101, the Office must (A) make a prima facie showing that the claimed invention lacks utility, and (B) provide a sufficient evidentiary basis for factual assumptions relied upon in establishing the prima facie showing. In re Gaubert, 524 F.2d 1222, 1224, 187 USPQ 664, 666 (CCPA 1975) "Accordingly, the PTO must do more than merely question operability – it must set forth factual reasons which would lead one skilled in the art to question the objective truth of the statement of operability." If the Office cannot develop a proper prima facie case and provide evidentiary support for a rejection under 35 U.S.C. 101, a rejection on this ground should not be imposed. See, e.g., In re Oetiker, 977 F.2d 1443, 1445, 24 USPQ2d 1443, 1444 (Fed. Cir. 1992) (“[T]he examiner bears the initial burden, on review of the prior art or on any other ground, of presenting a prima facie case of unpatentability. If that burden is met, the burden of coming forward with evidence or argument shifts to the applicant…. If examination at the initial stage does not produce a prima facie case of unpatentability, then without more the applicant is entitled to grant of the patent.”). See also Fregeau v. Mossinghoff, 776 F.2d 1034, 227 USPQ 848 (Fed. Cir. 1985) (applying prima facie case law to 35 U.S.C. 101); In re Piasecki, 745 F.2d 1468, 223 USPQ 785 (Fed. Cir. 1984).

To properly reject a claimed invention under 35 U.S.C. 101, the Office must (A) make a prima facie showing that the claimed invention lacks utility, and (B) provide a sufficient evidentiary basis for factual assumptions relied upon in establishing the prima facie showing. In re Gaubert, 524 F.2d 1222, 1224, 187 USPQ 664, 666 (CCPA 1975) "Accordingly, the PTO must do more than merely question operability – it must set forth factual reasons which would lead one skilled in the art to question the objective truth of the statement of operability." If the Office cannot develop a proper prima facie case and provide evidentiary support for a rejection under 35 U.S.C. 101, a rejection on this ground should not be imposed. See, e.g., In re Oetiker, 977 F.2d 1443, 1445, 24 USPQ2d 1443, 1444 (Fed. Cir. 1992) (“[T]he examiner bears the initial burden, on review of the prior art or on any other ground, of presenting a prima facie case of unpatentability. If that burden is met, the burden of coming forward with evidence or argument shifts to the applicant…. If examination at the initial stage does not produce a prima facie case of unpatentability, then without more the applicant is entitled to grant of the patent.”). See also Fregeau v. Mossinghoff, 776 F.2d 1034, 227 USPQ 848 (Fed. Cir. 1985) (applying prima facie case law to 35 U.S.C. 101); In re Piasecki, 745 F.2d 1468, 223 USPQ 785 (Fed. Cir. 1984).

To properly reject a claimed invention under 35 U.S.C. 101, the Office must (A) make a prima facie showing that the claimed invention lacks utility, and (B) provide a sufficient evidentiary basis for factual assumptions relied upon in establishing the prima facie showing. In re Gaubert, 524 F.2d 1222, 1224, 187 USPQ 664, 666 (CCPA 1975) "Accordingly, the PTO must do more than merely question operability – it must set forth factual reasons which would lead one skilled in the art to question the objective truth of the statement of operability." If the Office cannot develop a proper prima facie case and provide evidentiary support for a rejection under 35 U.S.C. 101, a rejection on this ground should not be imposed. See, e.g., In re Oetiker, 977 F.2d 1443, 1445, 24 USPQ2d 1443, 1444 (Fed. Cir. 1992) (“[T]he examiner bears the initial burden, on review of the prior art or on any other ground, of presenting a prima facie case of unpatentability. If that burden is met, the burden of coming forward with evidence or argument shifts to the applicant…. If examination at the initial stage does not produce a prima facie case of unpatentability, then without more the applicant is entitled to grant of the patent.”). See also Fregeau v. Mossinghoff, 776 F.2d 1034, 227 USPQ 848 (Fed. Cir. 1985) (applying prima facie case law to 35 U.S.C. 101); In re Piasecki, 745 F.2d 1468, 223 USPQ 785 (Fed. Cir. 1984).

It is common and sensible for an applicant to identify several specific utilities for an invention, particularly where the invention is a product (e.g., a machine, an article of manufacture or a composition of matter). However, regardless of the category of invention that is claimed (e.g., product or process), an applicant need only make one credible assertion of specific utility for the claimed invention to satisfy 35 U.S.C. 101 and 35 U.S.C. 112; additional statements of utility, even if not “credible,” do not render the claimed invention lacking in utility. See, e.g., Raytheon v. Roper, 724 F.2d 951, 958, 220 USPQ 592, 598 (Fed. Cir. 1983), cert. denied, 469 U.S. 835 (1984) (“When a properly claimed invention meets at least one stated objective, utility under 35 U.S.C. 101 is clearly shown.”); In re Gottlieb, 328 F.2d 1016, 1019, 140 USPQ 665, 668 (CCPA 1964) (“Having found that the antibiotic is useful for some purpose, it becomes unnecessary to decide whether it is in fact useful for the other purposes ‘indicated’ in the specification as possibly useful.”); In re Malachowski, 530 F.2d 1402, 189 USPQ 432 (CCPA 1976); Hoffman v. Klaus, 9 USPQ2d 1657 (Bd. Pat. App. & Inter. 1988). Thus, if applicant makes one credible assertion of utility, utility for the claimed invention as a whole is established.

Except where an invention has a well-established utility, the failure of an applicant to specifically identify why an invention is believed to be useful renders the claimed invention deficient under 35 U.S.C. 101 and 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph. In such cases, the applicant has failed to identify a “specific and substantial utility” for the claimed invention. For example, a statement that a composition has an unspecified “biological activity” or that does not explain why a composition with that activity is believed to be useful fails to set forth a “specific and substantial utility.” Brenner v. Manson, 383 US 519, 148 USPQ 689 (1966) (general assertion of similarities to known compounds known to be useful without sufficient corresponding explanation why claimed compounds are believed to be similarly useful insufficient under 35 U.S.C. 101); In re Ziegler, 992 F.2d 1197, 1201, 26 USPQ2d 1600, 1604 (Fed. Cir. 1993) (disclosure that composition is “plastic-like” and can form “films” not sufficient to identify specific and substantial utility for invention); In re Kirk, 376 F.2d 936, 153 USPQ 48 (CCPA 1967) (indication that compound is “biologically active” or has “biological properties” insufficient standing alone). See also In re Joly, 376 F.2d 906, 153 USPQ 45 (CCPA 1967); Kawai v. Metlesics, 480 F.2d 880, 890, 178 USPQ 158, 165 (CCPA 1973) (contrasting description of invention as sedative which did suggest specific utility to general suggestion of “pharmacological effects on the central nervous system” which did not). In contrast, a disclosure that identifies a particular biological activity of a compound and explains how that activity can be utilized in a particular therapeutic application of the compound does contain an assertion of specific and substantial utility for the invention.

Except where an invention has a well-established utility, the failure of an applicant to specifically identify why an invention is believed to be useful renders the claimed invention deficient under 35 U.S.C. 101 and 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph. In such cases, the applicant has failed to identify a “specific and substantial utility” for the claimed invention. For example, a statement that a composition has an unspecified “biological activity” or that does not explain why a composition with that activity is believed to be useful fails to set forth a “specific and substantial utility.” Brenner v. Manson, 383 US 519, 148 USPQ 689 (1966) (general assertion of similarities to known compounds known to be useful without sufficient corresponding explanation why claimed compounds are believed to be similarly useful insufficient under 35 U.S.C. 101); In re Ziegler, 992 F.2d 1197, 1201, 26 USPQ2d 1600, 1604 (Fed. Cir. 1993) (disclosure that composition is “plastic-like” and can form “films” not sufficient to identify specific and substantial utility for invention); In re Kirk, 376 F.2d 936, 153 USPQ 48 (CCPA 1967) (indication that compound is “biologically active” or has “biological properties” insufficient standing alone). See also In re Joly, 376 F.2d 906, 153 USPQ 45 (CCPA 1967); Kawai v. Metlesics, 480 F.2d 880, 890, 178 USPQ 158, 165 (CCPA 1973) (contrasting description of invention as sedative which did suggest specific utility to general suggestion of “pharmacological effects on the central nervous system” which did not). In contrast, a disclosure that identifies a particular biological activity of a compound and explains how that activity can be utilized in a particular therapeutic application of the compound does contain an assertion of specific and substantial utility for the invention.

Statements made by the applicant in the specification or incident to prosecution of the application before the Office cannot, standing alone, be the basis for a lack of utility rejection under 35 U.S.C. 101 or 35 U.S.C. 112. Tol-O-Matic, Inc. v. Proma Produkt-Und Mktg. Gesellschaft m.b.h., 945 F.2d 1546, 1553, 20 USPQ2d 1332, 1338 (Fed. Cir. 1991) (It is not required that a particular characteristic set forth in the prosecution history be achieved in order to satisfy 35 U.S.C. 101). An applicant may include statements in the specification whose technical accuracy cannot be easily confirmed if those statements are not necessary to support the patentability of an invention with regard to any statutory basis. Thus, the Office should not require an applicant to strike nonessential statements relating to utility from a patent disclosure, regardless of the technical accuracy of the statement or assertion it presents. Office personnel should also be especially careful not to read into a claim unclaimed results, limitations or embodiments of an invention. See Carl Zeiss Stiftung v. Renishaw PLC, 945 F.2d 1173, 20 USPQ2d 1094 (Fed. Cir. 1991); In re Krimmel, 292 F.2d 948, 130 USPQ 215 (CCPA 1961). Doing so can inappropriately change the relationship of an asserted utility to the claimed invention and raise issues not relevant to examination of that claim.

Statements made by the applicant in the specification or incident to prosecution of the application before the Office cannot, standing alone, be the basis for a lack of utility rejection under 35 U.S.C. 101 or 35 U.S.C. 112. Tol-O-Matic, Inc. v. Proma Produkt-Und Mktg. Gesellschaft m.b.h., 945 F.2d 1546, 1553, 20 USPQ2d 1332, 1338 (Fed. Cir. 1991) (It is not required that a particular characteristic set forth in the prosecution history be achieved in order to satisfy 35 U.S.C. 101). An applicant may include statements in the specification whose technical accuracy cannot be easily confirmed if those statements are not necessary to support the patentability of an invention with regard to any statutory basis. Thus, the Office should not require an applicant to strike nonessential statements relating to utility from a patent disclosure, regardless of the technical accuracy of the statement or assertion it presents. Office personnel should also be especially careful not to read into a claim unclaimed results, limitations or embodiments of an invention. See Carl Zeiss Stiftung v. Renishaw PLC, 945 F.2d 1173, 20 USPQ2d 1094 (Fed. Cir. 1991); In re Krimmel, 292 F.2d 948, 130 USPQ 215 (CCPA 1961). Doing so can inappropriately change the relationship of an asserted utility to the claimed invention and raise issues not relevant to examination of that claim.

Statements made by the applicant in the specification or incident to prosecution of the application before the Office cannot, standing alone, be the basis for a lack of utility rejection under 35 U.S.C. 101 or 35 U.S.C. 112. Tol-O-Matic, Inc. v. Proma Produkt-Und Mktg. Gesellschaft m.b.h., 945 F.2d 1546, 1553, 20 USPQ2d 1332, 1338 (Fed. Cir. 1991) (It is not required that a particular characteristic set forth in the prosecution history be achieved in order to satisfy 35 U.S.C. 101). An applicant may include statements in the specification whose technical accuracy cannot be easily confirmed if those statements are not necessary to support the patentability of an invention with regard to any statutory basis. Thus, the Office should not require an applicant to strike nonessential statements relating to utility from a patent disclosure, regardless of the technical accuracy of the statement or assertion it presents. Office personnel should also be especially careful not to read into a claim unclaimed results, limitations or embodiments of an invention. See Carl Zeiss Stiftung v. Renishaw PLC, 945 F.2d 1173, 20 USPQ2d 1094 (Fed. Cir. 1991); In re Krimmel, 292 F.2d 948, 130 USPQ 215 (CCPA 1961). Doing so can inappropriately change the relationship of an asserted utility to the claimed invention and raise issues not relevant to examination of that claim.

Upon initial examination, the examiner should review the specification to determine if there are any statements asserting that the claimed invention is useful for any particular purpose. A complete disclosure should include a statement which identifies a specific and substantial utility for the invention.

Upon initial examination, the examiner should review the specification to determine if there are any statements asserting that the claimed invention is useful for any particular purpose. A complete disclosure should include a statement which identifies a specific and substantial utility for the invention.

As a matter of Patent Office practice, a specification which contains a disclosure of utility which corresponds in scope to the subject matter sought to be patented must be taken as sufficient to satisfy the utility requirement of § 101 for the entire claimed subject matter unless there is a reason for one skilled in the art to question the objective truth of the statement of utility or its scope.

To properly reject a claimed invention under 35 U.S.C. 101, the Office must (A) make a prima facie showing that the claimed invention lacks utility, and (B) provide a sufficient evidentiary basis for factual assumptions relied upon in establishing the prima facie showing. In re Gaubert, 524 F.2d 1222, 1224, 187 USPQ 664, 666 (CCPA 1975) "Accordingly, the PTO must do more than merely question operability – it must set forth factual reasons which would lead one skilled in the art to question the objective truth of the statement of operability." If the Office cannot develop a proper prima facie case and provide evidentiary support for a rejection under 35 U.S.C. 101, a rejection on this ground should not be imposed. See, e.g., In re Oetiker, 977 F.2d 1443, 1445, 24 USPQ2d 1443, 1444 (Fed. Cir. 1992) (“[T]he examiner bears the initial burden, on review of the prior art or on any other ground, of presenting a prima facie case of unpatentability. If that burden is met, the burden of coming forward with evidence or argument shifts to the applicant…. If examination at the initial stage does not produce a prima facie case of unpatentability, then without more the applicant is entitled to grant of the patent.”). See also Fregeau v. Mossinghoff, 776 F.2d 1034, 227 USPQ 848 (Fed. Cir. 1985) (applying prima facie case law to 35 U.S.C. 101); In re Piasecki, 745 F.2d 1468, 223 USPQ 785 (Fed. Cir. 1984).

To properly reject a claimed invention under 35 U.S.C. 101, the Office must (A) make a prima facie showing that the claimed invention lacks utility, and (B) provide a sufficient evidentiary basis for factual assumptions relied upon in establishing the prima facie showing. In re Gaubert, 524 F.2d 1222, 1224, 187 USPQ 664, 666 (CCPA 1975) "Accordingly, the PTO must do more than merely question operability – it must set forth factual reasons which would lead one skilled in the art to question the objective truth of the statement of operability." If the Office cannot develop a proper prima facie case and provide evidentiary support for a rejection under 35 U.S.C. 101, a rejection on this ground should not be imposed. See, e.g., In re Oetiker, 977 F.2d 1443, 1445, 24 USPQ2d 1443, 1444 (Fed. Cir. 1992) (“[T]he examiner bears the initial burden, on review of the prior art or on any other ground, of presenting a prima facie case of unpatentability. If that burden is met, the burden of coming forward with evidence or argument shifts to the applicant…. If examination at the initial stage does not produce a prima facie case of unpatentability, then without more the applicant is entitled to grant of the patent.”). See also Fregeau v. Mossinghoff, 776 F.2d 1034, 227 USPQ 848 (Fed. Cir. 1985) (applying prima facie case law to 35 U.S.C. 101); In re Piasecki, 745 F.2d 1468, 223 USPQ 785 (Fed. Cir. 1984).

It is imperative that Office personnel use specificity in setting forth and initial rejection under 35 U.S.C. 101 and support any factual conclusions made in the prima facie showing.

If a person of ordinary skill would not immediately recognize a specific and substantial utility for the claimed invention (i.e., why it would be useful) based on the characteristics of the invention or statements made by the applicant, the examiner should reject the application under 35 U.S.C. 101 and under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, as failing to identify a specific and substantial utility for the claimed invention. The rejection should clearly indicate that the basis of the rejection is that the application fails to identify a specific and substantial utility for the invention. The rejection should also specify that the applicant must reply by indicating why the invention is believed useful and where support for any subsequently asserted utility can be found in the specification as filed. See MPEP § 2701.

Rejections under 35 U.S.C. 101 based on a lack of credible utility have been sustained by federal courts when, for example, the applicant failed to disclose any utility for the invention or asserted a utility that could only be true if it violated a scientific principle, such as the second law of thermodynamics, or a law of nature, or was wholly inconsistent with contemporary knowledge in the art. In re Gazave, 379 F.2d 973, 978, 154 USPQ 92, 96 (CCPA 1967). Special care should be taken when assessing the credibility of an asserted therapeutic utility for a claimed invention. In such cases, a previous lack of success in treating a disease or condition, or the absence of a proven animal model for testing the effectiveness of drugs for treating a disorder in humans, should not, standing alone, serve as a basis for challenging the asserted utility under 35 U.S.C. 101. See MPEP § 2107.03 for additional guidance with regard to therapeutic or pharmacological utilities.

[A] specification disclosure which contains a teaching of the manner and process of making and using the invention in terms which correspond in scope to those used in describing and defining the subject matter sought to be patented must be taken as in compliance with the enabling requirement of the first paragraph of § 112 unless there is reason to doubt the objective truth of the statements contained therein which must be relied on for enabling support. (emphasis added).

[A] specification disclosure which contains a teaching of the manner and process of making and using the invention in terms which correspond in scope to those used in describing and defining the subject matter sought to be patented must be taken as in compliance with the enabling requirement of the first paragraph of § 112 unless there is reason to doubt the objective truth of the statements contained therein which must be relied on for enabling support. (emphasis added).

It is common and sensible for an applicant to identify several specific utilities for an invention, particularly where the invention is a product (e.g., a machine, an article of manufacture or a composition of matter). However, regardless of the category of invention that is claimed (e.g., product or process), an applicant need only make one credible assertion of specific utility for the claimed invention to satisfy 35 U.S.C. 101 and 35 U.S.C. 112; additional statements of utility, even if not “credible,” do not render the claimed invention lacking in utility. See, e.g., Raytheon v. Roper, 724 F.2d 951, 958, 220 USPQ 592, 598 (Fed. Cir. 1983), cert. denied, 469 U.S. 835 (1984) (“When a properly claimed invention meets at least one stated objective, utility under 35 U.S.C. 101 is clearly shown.”); In re Gottlieb, 328 F.2d 1016, 1019, 140 USPQ 665, 668 (CCPA 1964) (“Having found that the antibiotic is useful for some purpose, it becomes unnecessary to decide whether it is in fact useful for the other purposes ‘indicated’ in the specification as possibly useful.”); In re Malachowski, 530 F.2d 1402, 189 USPQ 432 (CCPA 1976); Hoffman v. Klaus, 9 USPQ2d 1657 (Bd. Pat. App. & Inter. 1988). Thus, if applicant makes one credible assertion of utility, utility for the claimed invention as a whole is established.

Statements made by the applicant in the specification or incident to prosecution of the application before the Office cannot, standing alone, be the basis for a lack of utility rejection under 35 U.S.C. 101 or 35 U.S.C. 112. Tol-O-Matic, Inc. v. Proma Produkt-Und Mktg. Gesellschaft m.b.h., 945 F.2d 1546, 1553, 20 USPQ2d 1332, 1338 (Fed. Cir. 1991) (It is not required that a particular characteristic set forth in the prosecution history be achieved in order to satisfy 35 U.S.C. 101). An applicant may include statements in the specification whose technical accuracy cannot be easily confirmed if those statements are not necessary to support the patentability of an invention with regard to any statutory basis. Thus, the Office should not require an applicant to strike nonessential statements relating to utility from a patent disclosure, regardless of the technical accuracy of the statement or assertion it presents. Office personnel should also be especially careful not to read into a claim unclaimed results, limitations or embodiments of an invention. See Carl Zeiss Stiftung v. Renishaw PLC, 945 F.2d 1173, 20 USPQ2d 1094 (Fed. Cir. 1991); In re Krimmel, 292 F.2d 948, 130 USPQ 215 (CCPA 1961). Doing so can inappropriately change the relationship of an asserted utility to the claimed invention and raise issues not relevant to examination of that claim.

Statements made by the applicant in the specification or incident to prosecution of the application before the Office cannot, standing alone, be the basis for a lack of utility rejection under 35 U.S.C. 101 or 35 U.S.C. 112. Tol-O-Matic, Inc. v. Proma Produkt-Und Mktg. Gesellschaft m.b.h., 945 F.2d 1546, 1553, 20 USPQ2d 1332, 1338 (Fed. Cir. 1991) (It is not required that a particular characteristic set forth in the prosecution history be achieved in order to satisfy 35 U.S.C. 101). An applicant may include statements in the specification whose technical accuracy cannot be easily confirmed if those statements are not necessary to support the patentability of an invention with regard to any statutory basis. Thus, the Office should not require an applicant to strike nonessential statements relating to utility from a patent disclosure, regardless of the technical accuracy of the statement or assertion it presents. Office personnel should also be especially careful not to read into a claim unclaimed results, limitations or embodiments of an invention. See Carl Zeiss Stiftung v. Renishaw PLC, 945 F.2d 1173, 20 USPQ2d 1094 (Fed. Cir. 1991); In re Krimmel, 292 F.2d 948, 130 USPQ 215 (CCPA 1961). Doing so can inappropriately change the relationship of an asserted utility to the claimed invention and raise issues not relevant to examination of that claim.

Statements made by the applicant in the specification or incident to prosecution of the application before the Office cannot, standing alone, be the basis for a lack of utility rejection under 35 U.S.C. 101 or 35 U.S.C. 112. Tol-O-Matic, Inc. v. Proma Produkt-Und Mktg. Gesellschaft m.b.h., 945 F.2d 1546, 1553, 20 USPQ2d 1332, 1338 (Fed. Cir. 1991) (It is not required that a particular characteristic set forth in the prosecution history be achieved in order to satisfy 35 U.S.C. 101). An applicant may include statements in the specification whose technical accuracy cannot be easily confirmed if those statements are not necessary to support the patentability of an invention with regard to any statutory basis. Thus, the Office should not require an applicant to strike nonessential statements relating to utility from a patent disclosure, regardless of the technical accuracy of the statement or assertion it presents. Office personnel should also be especially careful not to read into a claim unclaimed results, limitations or embodiments of an invention. See Carl Zeiss Stiftung v. Renishaw PLC, 945 F.2d 1173, 20 USPQ2d 1094 (Fed. Cir. 1991); In re Krimmel, 292 F.2d 948, 130 USPQ 215 (CCPA 1961). Doing so can inappropriately change the relationship of an asserted utility to the claimed invention and raise issues not relevant to examination of that claim.

Situations where an applicant either fails to indicate why an invention is considered useful, or where the applicant inaccurately describes the utility should rarely arise. One reason for this is that applicants are required to disclose the best mode known to them of practicing the invention at the time they file their application. An applicant who omits a description of the specific and substantial utility of the invention, or who incompletely describes that utility, may encounter problems with respect to the best mode requirement of 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph.

Occasionally, an applicant will not explicitly state in the specification or otherwise assert a specific and substantial utility for the claimed invention. If no statements can be found asserting a specific and substantial utility for the claimed invention in the specification, Office personnel should determine if the claimed invention has a well-established utility. An invention has a well-established utility if (i) a person of ordinary skill in the art would immediately appreciate why the invention is useful based on the characteristics of the invention (e.g., properties or applications of a product or process), and (ii) the utility is specific, substantial, and credible. If an invention has a well- established utility, rejections under 35 U.S.C. 101 and 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, based on lack of utility should not be imposed. In re Folkers, 344 F.2d 970, 145 USPQ 390 (CCPA 1965). For example, if an application teaches the cloning and characterization of the nucleotide sequence of a well-known protein such as insulin, and those skilled in the art at the time of filing knew that insulin had a well-established use, it would be improper to reject the claimed invention as lacking utility solely because of the omitted statement of specific and substantial utility.

In re Langer, 503 F.2d at 1391, 183 USPQ at 297 (emphasis in original). The “Langer” test for utility has been used by both the Federal Circuit and the Court of Customs and Patent Appeals in evaluation of rejections under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, where the rejection is based on a deficiency under 35 U.S.C. 101. In In re Brana, 51 F.3d 1560, 34 USPQ2d 1436 (Fed. Cir. 1995), the Federal Circuit explicitly adopted the Court of Customs and Patent Appeals formulation of the “Langer” standard for 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph rejections, as it was expressed in a slightly reworded format in In re Marzocchi, 439 F.2d 220, 223, 169 USPQ 367, 369 (CCPA 1971), namely:

1. Where the specification would not enable one skilled in the art to make the claimed invention, or where alternative reasons support the enablement rejection, a separate rejection under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, enablement should be made using the factors set forth in In re Wands, 858 F.2d 731, 8 USPQ2d 1400 (Fed. Cir. 1988) and an undue experimentation analysis. See MPEP §§ 2164 – 2164.08(c).

If a rejection under 35 U.S.C. 101 has been properly imposed, along with a corresponding rejection under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, the burden shifts to the applicant to rebut the prima facie showing. In re Oetiker, 977 F.2d 1443, 1445, 24 USPQ2d 1443, 1444 (Fed. Cir. 1992) (“The examiner bears the initial burden, on review of the prior art or on any other ground, of presenting a prima facie case of unpatentability. If that burden is met, the burden of coming forward with evidence or argument shifts to the applicant… After evidence or argument is submitted by the applicant in response, patentability is determined on the totality of the record, by a preponderance of evidence with due consideration to persuasiveness of argument.”). An applicant can do this using any combination of the following: amendments to the claims, arguments or reasoning, or new evidence submitted in an affidavit or declaration under 37 CFR 1.132, or in a printed publication. New evidence provided by an applicant must be relevant to the issues raised in the rejection. For example, declarations in which conclusions are set forth without establishing a nexus between those conclusions and the supporting evidence, or which merely express opinions, may be of limited probative value with regard to rebutting a prima facie case. In re Grunwell, 609 F.2d 486, 203 USPQ 1055 (CCPA 1979); In re Buchner, 929 F.2d 660, 18 USPQ2d 1331 (Fed. Cir. 1991). See MPEP § 716.01(a) through MPEP § 716.01(c).