Normally, only one reference should be used in making a rejection under 35 U.S.C. 102. However, a 35 U.S.C. 102 rejection over multiple references has been held to be proper when the extra references are cited to:

• (A) Prove the primary reference contains an “enabled disclosure;”
• (B) Explain the meaning of a term used in the primary reference; or
• (C) Show that a characteristic not disclosed in the reference is inherent.

Normally, only one reference should be used in making a rejection under 35 U.S.C. 102. However, a 35 U.S.C. 102 rejection over multiple references has been held to be proper when the extra references are cited to (A) Prove the primary reference contains an “enabled disclosure;”

Extrinsic evidence may be used to explain but not expand the meaning of terms and phrases used in the reference relied upon as anticipatory of the claimed subject matter. In re Baxter Travenol Labs., 952 F.2d 388, 21 USPQ2d 1281 (Fed. Cir. 1991) (Baxter Travenol Labs. invention was directed to a blood bag system incorporating a bag containing DEHP, an additive to the plastic which improved the bag’s red blood cell storage capability. The examiner rejected the claims over a technical progress report by Becker which taught the same blood bag system but did not expressly disclose the presence of DEHP. The report, however, did disclose using commercial blood bags. It also disclosed the blood bag system as “very similar to [Baxter] Travenol’s commercial two bag blood container.” Extrinsic evidence (depositions, declarations and Baxter Travenol’s own admissions) showed that commercial blood bags, at the time Becker’s report was written, contained DEHP. Therefore, one of ordinary skill in the art would have known that “commercial blood bags” meant bags containing DEHP. The claims were thus held to be anticipated.).

Extrinsic evidence may be used to explain but not expand the meaning of terms and phrases used in the reference relied upon as anticipatory of the claimed subject matter. In re Baxter Travenol Labs., 952 F.2d 388, 21 USPQ2d 1281 (Fed. Cir. 1991) (Baxter Travenol Labs. invention was directed to a blood bag system incorporating a bag containing DEHP, an additive to the plastic which improved the bag’s red blood cell storage capability. The examiner rejected the claims over a technical progress report by Becker which taught the same blood bag system but did not expressly disclose the presence of DEHP. The report, however, did disclose using commercial blood bags. It also disclosed the blood bag system as “very similar to [Baxter] Travenol’s commercial two bag blood container.” Extrinsic evidence (depositions, declarations and Baxter Travenol’s own admissions) showed that commercial blood bags, at the time Becker’s report was written, contained DEHP. Therefore, one of ordinary skill in the art would have known that “commercial blood bags” meant bags containing DEHP. The claims were thus held to be anticipated.).

Extrinsic evidence may be used to explain but not expand the meaning of terms and phrases used in the reference relied upon as anticipatory of the claimed subject matter. In re Baxter Travenol Labs., 952 F.2d 388, 21 USPQ2d 1281 (Fed. Cir. 1991) (Baxter Travenol Labs. invention was directed to a blood bag system incorporating a bag containing DEHP, an additive to the plastic which improved the bag’s red blood cell storage capability. The examiner rejected the claims over a technical progress report by Becker which taught the same blood bag system but did not expressly disclose the presence of DEHP. The report, however, did disclose using commercial blood bags. It also disclosed the blood bag system as “very similar to [Baxter] Travenol’s commercial two bag blood container.” Extrinsic evidence (depositions, declarations and Baxter Travenol’s own admissions) showed that commercial blood bags, at the time Becker’s report was written, contained DEHP. Therefore, one of ordinary skill in the art would have known that “commercial blood bags” meant bags containing DEHP. The claims were thus held to be anticipated.).

Extrinsic evidence may be used to explain but not expand the meaning of terms and phrases used in the reference relied upon as anticipatory of the claimed subject matter. In re Baxter Travenol Labs., 952 F.2d 388, 21 USPQ2d 1281 (Fed. Cir. 1991) (Baxter Travenol Labs. invention was directed to a blood bag system incorporating a bag containing DEHP, an additive to the plastic which improved the bag’s red blood cell storage capability. The examiner rejected the claims over a technical progress report by Becker which taught the same blood bag system but did not expressly disclose the presence of DEHP. The report, however, did disclose using commercial blood bags. It also disclosed the blood bag system as “very similar to [Baxter] Travenol’s commercial two bag blood container.” Extrinsic evidence (depositions, declarations and Baxter Travenol’s own admissions) showed that commercial blood bags, at the time Becker’s report was written, contained DEHP. Therefore, one of ordinary skill in the art would have known that “commercial blood bags” meant bags containing DEHP. The claims were thus held to be anticipated.).

Extrinsic evidence may be used to explain but not expand the meaning of terms and phrases used in the reference relied upon as anticipatory of the claimed subject matter. In re Baxter Travenol Labs., 952 F.2d 388, 21 USPQ2d 1281 (Fed. Cir. 1991) (Baxter Travenol Labs. invention was directed to a blood bag system incorporating a bag containing DEHP, an additive to the plastic which improved the bag’s red blood cell storage capability. The examiner rejected the claims over a technical progress report by Becker which taught the same blood bag system but did not expressly disclose the presence of DEHP. The report, however, did disclose using commercial blood bags. It also disclosed the blood bag system as “very similar to [Baxter] Travenol’s commercial two bag blood container.” Extrinsic evidence (depositions, declarations and Baxter Travenol’s own admissions) showed that commercial blood bags, at the time Becker’s report was written, contained DEHP. Therefore, one of ordinary skill in the art would have known that “commercial blood bags” meant bags containing DEHP. The claims were thus held to be anticipated.).

Extrinsic evidence may be used to explain but not expand the meaning of terms and phrases used in the reference relied upon as anticipatory of the claimed subject matter. In re Baxter Travenol Labs., 952 F.2d 388, 21 USPQ2d 1281 (Fed. Cir. 1991) (Baxter Travenol Labs. invention was directed to a blood bag system incorporating a bag containing DEHP, an additive to the plastic which improved the bag’s red blood cell storage capability. The examiner rejected the claims over a technical progress report by Becker which taught the same blood bag system but did not expressly disclose the presence of DEHP. The report, however, did disclose using commercial blood bags. It also disclosed the blood bag system as “very similar to [Baxter] Travenol’s commercial two bag blood container.” Extrinsic evidence (depositions, declarations and Baxter Travenol’s own admissions) showed that commercial blood bags, at the time Becker’s report was written, contained DEHP. Therefore, one of ordinary skill in the art would have known that “commercial blood bags” meant bags containing DEHP. The claims were thus held to be anticipated.).

In Actelion Pharmaceuticals Ltd v. Mylan Pharmaceuticals Inc., 85 F.4th 1167, 1171-74, 2023 USPQ2d 1314 (Fed. Cir. 2023), the court reviewed the intrinsic evidence including the claims, specification, and prosecution history and held that the meaning of the claim term “a pH of 13 or higher” could not be determined without turning to extrinsic evidence. It was unclear from the claims whether “a pH of 13 or higher” “carries any meaning to a person of ordinary skill in the art as regards precision of measurement, significant digits, or rounding.” Id. at 1171-1172. The specification also was unclear about any desired level of precision for the term, inconsistently describing the level of specificity for a pH of 13. Id. at 1172-1173. Finally, the prosecution history also did not illuminate a level of precision and whether “pH of 13” encompassed values that round to 13, such as 12.5. Id. at 1173. The court therefore found that in this case extrinsic evidence should be consulted to understand “the meaning of a term in the relevant art during the relevant time period”. Actelion, 85 F.4th at 1174 (quoting Teva Pharmaceuticals USA, Inc v. Sandoz, Inc., 574 U.S. 318, 331,135 S. Ct. 831, 841, 113 USPQ2d 1269, 1276 (2015)).

In Actelion Pharmaceuticals Ltd v. Mylan Pharmaceuticals Inc., 85 F.4th 1167, 1171-74, 2023 USPQ2d 1314 (Fed. Cir. 2023), the court reviewed the intrinsic evidence including the claims, specification, and prosecution history and held that the meaning of the claim term “a pH of 13 or higher” could not be determined without turning to extrinsic evidence. It was unclear from the claims whether “a pH of 13 or higher” “carries any meaning to a person of ordinary skill in the art as regards precision of measurement, significant digits, or rounding.” Id. at 1171-1172. The specification also was unclear about any desired level of precision for the term, inconsistently describing the level of specificity for a pH of 13. Id. at 1172-1173. Finally, the prosecution history also did not illuminate a level of precision and whether “pH of 13” encompassed values that round to 13, such as 12.5. Id. at 1173. The court therefore found that in this case extrinsic evidence should be consulted to understand “the meaning of a term in the relevant art during the relevant time period”. Actelion, 85 F.4th at 1174 (quoting Teva Pharmaceuticals USA, Inc v. Sandoz, Inc., 574 U.S. 318, 331,135 S. Ct. 831, 841, 113 USPQ2d 1269, 1276 (2015)).

In Actelion Pharmaceuticals Ltd v. Mylan Pharmaceuticals Inc., 85 F.4th 1167, 1171-74, 2023 USPQ2d 1314 (Fed. Cir. 2023), the court reviewed the intrinsic evidence including the claims, specification, and prosecution history and held that the meaning of the claim term “a pH of 13 or higher” could not be determined without turning to extrinsic evidence. It was unclear from the claims whether “a pH of 13 or higher” “carries any meaning to a person of ordinary skill in the art as regards precision of measurement, significant digits, or rounding.” Id. at 1171-1172. The specification also was unclear about any desired level of precision for the term, inconsistently describing the level of specificity for a pH of 13. Id. at 1172-1173. Finally, the prosecution history also did not illuminate a level of precision and whether “pH of 13” encompassed values that round to 13, such as 12.5. Id. at 1173. The court therefore found that in this case extrinsic evidence should be consulted to understand “the meaning of a term in the relevant art during the relevant time period”. Actelion, 85 F.4th at 1174 (quoting Teva Pharmaceuticals USA, Inc v. Sandoz, Inc., 574 U.S. 318, 331,135 S. Ct. 831, 841, 113 USPQ2d 1269, 1276 (2015)).

In Actelion Pharmaceuticals Ltd v. Mylan Pharmaceuticals Inc., 85 F.4th 1167, 1171-74, 2023 USPQ2d 1314 (Fed. Cir. 2023), the court reviewed the intrinsic evidence including the claims, specification, and prosecution history and held that the meaning of the claim term “a pH of 13 or higher” could not be determined without turning to extrinsic evidence. It was unclear from the claims whether “a pH of 13 or higher” “carries any meaning to a person of ordinary skill in the art as regards precision of measurement, significant digits, or rounding.” Id. at 1171-1172. The specification also was unclear about any desired level of precision for the term, inconsistently describing the level of specificity for a pH of 13. Id. at 1172-1173. Finally, the prosecution history also did not illuminate a level of precision and whether “pH of 13” encompassed values that round to 13, such as 12.5. Id. at 1173. The court therefore found that in this case extrinsic evidence should be consulted to understand “the meaning of a term in the relevant art during the relevant time period”. Actelion, 85 F.4th at 1174 (quoting Teva Pharmaceuticals USA, Inc v. Sandoz, Inc., 574 U.S. 318, 331,135 S. Ct. 831, 841, 113 USPQ2d 1269, 1276 (2015)).

“To serve as an anticipation when the reference is silent about the asserted inherent characteristic, such gap in the reference may be filled with recourse to extrinsic evidence. Such evidence must make clear that the missing descriptive matter is necessarily present in the thing described in the reference, and that it would be so recognized by persons of ordinary skill.” Continental Can Co. USA v. Monsanto Co., 948 F.2d 1264, 1268, 20 USPQ2d 1746, 1749-50 (Fed. Cir. 1991) (The court went on to explain that “this modest flexibility in the rule that ‘anticipation’ requires that every element of the claims appear in a single reference accommodates situations in which the common knowledge of technologists is not recorded in the reference; that is, where technological facts are known to those in the field of the invention, albeit not known to judges.” 948 F.2d at 1268, 20 USPQ at 1749-50.). Note that as long as there is evidence of record establishing inherency, failure of those skilled in the art to contemporaneously recognize an inherent property, function or ingredient of a prior art reference does not preclude a finding of anticipation. Atlas Powder Co. v. IRECO, Inc., 190 F.3d 1342, 1349, 51 USPQ2d 1943, 1948 (Fed. Cir. 1999) (Two prior art references disclosed blasting compositions containing water-in-oil emulsions with identical ingredients to those claimed, in overlapping ranges with the claimed composition. The only element of the claims arguably not present in the prior art compositions was “sufficient aeration… entrapped to enhance sensitivity to a substantial degree.” The Federal Circuit found that the emulsions described in both references would inevitably and inherently have “sufficient aeration” to sensitize the compound in the claimed ranges based on the evidence of record (including test data and expert testimony). This finding of inherency was not defeated by the fact that one of the references taught away from air entrapment or purposeful aeration.). See also In re King, 801 F.2d 1324, 1327, 231 USPQ 136, 139 (Fed. Cir. 1986); Titanium Metals Corp. v. Banner, 778 F.2d 775, 782, 227 USPQ 773, 778 (Fed. Cir. 1985). See MPEP § 2112 – § 2112.02 for case law on inherency. Also note that the critical date of extrinsic evidence showing a universal fact need not antedate the filing date. See MPEP § 2124.

“To serve as an anticipation when the reference is silent about the asserted inherent characteristic, such gap in the reference may be filled with recourse to extrinsic evidence. Such evidence must make clear that the missing descriptive matter is necessarily present in the thing described in the reference, and that it would be so recognized by persons of ordinary skill.” Continental Can Co. USA v. Monsanto Co., 948 F.2d 1264, 1268, 20 USPQ2d 1746, 1749-50 (Fed. Cir. 1991) (The court went on to explain that “this modest flexibility in the rule that ‘anticipation’ requires that every element of the claims appear in a single reference accommodates situations in which the common knowledge of technologists is not recorded in the reference; that is, where technological facts are known to those in the field of the invention, albeit not known to judges.” 948 F.2d at 1268, 20 USPQ at 1749-50.). Note that as long as there is evidence of record establishing inherency, failure of those skilled in the art to contemporaneously recognize an inherent property, function or ingredient of a prior art reference does not preclude a finding of anticipation. Atlas Powder Co. v. IRECO, Inc., 190 F.3d 1342, 1349, 51 USPQ2d 1943, 1948 (Fed. Cir. 1999) (Two prior art references disclosed blasting compositions containing water-in-oil emulsions with identical ingredients to those claimed, in overlapping ranges with the claimed composition. The only element of the claims arguably not present in the prior art compositions was “sufficient aeration… entrapped to enhance sensitivity to a substantial degree.” The Federal Circuit found that the emulsions described in both references would inevitably and inherently have “sufficient aeration” to sensitize the compound in the claimed ranges based on the evidence of record (including test data and expert testimony). This finding of inherency was not defeated by the fact that one of the references taught away from air entrapment or purposeful aeration.). See also In re King, 801 F.2d 1324, 1327, 231 USPQ 136, 139 (Fed. Cir. 1986); Titanium Metals Corp. v. Banner, 778 F.2d 775, 782, 227 USPQ 773, 778 (Fed. Cir. 1985). See MPEP § 2112 – § 2112.02 for case law on inherency. Also note that the critical date of extrinsic evidence showing a universal fact need not antedate the filing date. See MPEP § 2124.

“To serve as an anticipation when the reference is silent about the asserted inherent characteristic, such gap in the reference may be filled with recourse to extrinsic evidence. Such evidence must make clear that the missing descriptive matter is necessarily present in the thing described in the reference, and that it would be so recognized by persons of ordinary skill.” Continental Can Co. USA v. Monsanto Co., 948 F.2d 1264, 1268, 20 USPQ2d 1746, 1749-50 (Fed. Cir. 1991) (The court went on to explain that “this modest flexibility in the rule that ‘anticipation’ requires that every element of the claims appear in a single reference accommodates situations in which the common knowledge of technologists is not recorded in the reference; that is, where technological facts are known to those in the field of the invention, albeit not known to judges.” 948 F.2d at 1268, 20 USPQ at 1749-50.). Note that as long as there is evidence of record establishing inherency, failure of those skilled in the art to contemporaneously recognize an inherent property, function or ingredient of a prior art reference does not preclude a finding of anticipation. Atlas Powder Co. v. IRECO, Inc., 190 F.3d 1342, 1349, 51 USPQ2d 1943, 1948 (Fed. Cir. 1999) (Two prior art references disclosed blasting compositions containing water-in-oil emulsions with identical ingredients to those claimed, in overlapping ranges with the claimed composition. The only element of the claims arguably not present in the prior art compositions was “sufficient aeration… entrapped to enhance sensitivity to a substantial degree.” The Federal Circuit found that the emulsions described in both references would inevitably and inherently have “sufficient aeration” to sensitize the compound in the claimed ranges based on the evidence of record (including test data and expert testimony). This finding of inherency was not defeated by the fact that one of the references taught away from air entrapment or purposeful aeration.). See also In re King, 801 F.2d 1324, 1327, 231 USPQ 136, 139 (Fed. Cir. 1986); Titanium Metals Corp. v. Banner, 778 F.2d 775, 782, 227 USPQ 773, 778 (Fed. Cir. 1985). See MPEP § 2112 – § 2112.02 for case law on inherency. Also note that the critical date of extrinsic evidence showing a universal fact need not antedate the filing date. See MPEP § 2124.

When the claimed composition or machine is disclosed identically by the reference, an additional reference may be relied on to show that the primary reference has an “enabled disclosure.” In re Samour, 571 F.2d 559, 197 USPQ 1 (CCPA 1978) and In re Donohue, 766 F.2d 531, 226 USPQ 619 (Fed. Cir. 1985) (Compound claims were rejected under pre-AIA 35 U.S.C. 102(b) over a publication in view of two patents. The publication disclosed the claimed compound structure while the patents taught methods of making compounds of that general class. The applicant argued that there was no motivation to combine the references because no utility was previously known for the compound and that the 35 U.S.C. 102 rejection over multiple references was improper. The court held that the publication taught all the elements of the claim and thus motivation to combine was not required. The patents were only submitted as evidence of what was in the public's possession before the invention.).

When the claimed composition or machine is disclosed identically by the reference, an additional reference may be relied on to show that the primary reference has an “enabled disclosure.” In re Samour, 571 F.2d 559, 197 USPQ 1 (CCPA 1978) and In re Donohue, 766 F.2d 531, 226 USPQ 619 (Fed. Cir. 1985) (Compound claims were rejected under pre-AIA 35 U.S.C. 102(b) over a publication in view of two patents. The publication disclosed the claimed compound structure while the patents taught methods of making compounds of that general class. The applicant argued that there was no motivation to combine the references because no utility was previously known for the compound and that the 35 U.S.C. 102 rejection over multiple references was improper. The court held that the publication taught all the elements of the claim and thus motivation to combine was not required. The patents were only submitted as evidence of what was in the public's possession before the invention.).

When the claimed composition or machine is disclosed identically by the reference, an additional reference may be relied on to show that the primary reference has an “enabled disclosure.” In re Samour, 571 F.2d 559, 197 USPQ 1 (CCPA 1978) and In re Donohue, 766 F.2d 531, 226 USPQ 619 (Fed. Cir. 1985) (Compound claims were rejected under pre-AIA 35 U.S.C. 102(b) over a publication in view of two patents. The publication disclosed the claimed compound structure while the patents taught methods of making compounds of that general class. The applicant argued that there was no motivation to combine the references because no utility was previously known for the compound and that the 35 U.S.C. 102 rejection over multiple references was improper. The court held that the publication taught all the elements of the claim and thus motivation to combine was not required. The patents were only submitted as evidence of what was in the public's possession before the invention.).

Normally, only one reference should be used in making a rejection under 35 U.S.C. 102. However, a 35 U.S.C. 102 rejection over multiple references has been held to be proper when the extra references are cited to:
…
(C) Show that a characteristic not disclosed in the reference is inherent.

“To serve as an anticipation when the reference is silent about the asserted inherent characteristic, such gap in the reference may be filled with recourse to extrinsic evidence. Such evidence must make clear that the missing descriptive matter is necessarily present in the thing described in the reference, and that it would be so recognized by persons of ordinary skill.” Continental Can Co. USA v. Monsanto Co., 948 F.2d 1264, 1268, 20 USPQ2d 1746, 1749-50 (Fed. Cir. 1991) (The court went on to explain that “this modest flexibility in the rule that ‘anticipation’ requires that every element of the claims appear in a single reference accommodates situations in which the common knowledge of technologists is not recorded in the reference; that is, where technological facts are known to those in the field of the invention, albeit not known to judges.” 948 F.2d at 1268, 20 USPQ at 1749-50.). Note that as long as there is evidence of record establishing inherency, failure of those skilled in the art to contemporaneously recognize an inherent property, function or ingredient of a prior art reference does not preclude a finding of anticipation. Atlas Powder Co. v. IRECO, Inc., 190 F.3d 1342, 1349, 51 USPQ2d 1943, 1948 (Fed. Cir. 1999) (Two prior art references disclosed blasting compositions containing water-in-oil emulsions with identical ingredients to those claimed, in overlapping ranges with the claimed composition. The only element of the claims arguably not present in the prior art compositions was “sufficient aeration… entrapped to enhance sensitivity to a substantial degree.” The Federal Circuit found that the emulsions described in both references would inevitably and inherently have “sufficient aeration” to sensitize the compound in the claimed ranges based on the evidence of record (including test data and expert testimony). This finding of inherency was not defeated by the fact that one of the references taught away from air entrapment or purposeful aeration.). See also In re King, 801 F.2d 1324, 1327, 231 USPQ 136, 139 (Fed. Cir. 1986); Titanium Metals Corp. v. Banner, 778 F.2d 775, 782, 227 USPQ 773, 778 (Fed. Cir. 1985). See MPEP § 2112 – § 2112.02 for case law on inherency. Also note that the critical date of extrinsic evidence showing a universal fact need not antedate the filing date. See MPEP § 2124.

“To serve as an anticipation when the reference is silent about the asserted inherent characteristic, such gap in the reference may be filled with recourse to extrinsic evidence. Such evidence must make clear that the missing descriptive matter is necessarily present in the thing described in the reference, and that it would be so recognized by persons of ordinary skill.” Continental Can Co. USA v. Monsanto Co., 948 F.2d 1264, 1268, 20 USPQ2d 1746, 1749-50 (Fed. Cir. 1991) (The court went on to explain that “this modest flexibility in the rule that ‘anticipation’ requires that every element of the claims appear in a single reference accommodates situations in which the common knowledge of technologists is not recorded in the reference; that is, where technological facts are known to those in the field of the invention, albeit not known to judges.” 948 F.2d at 1268, 20 USPQ at 1749-50.). Note that as long as there is evidence of record establishing inherency, failure of those skilled in the art to contemporaneously recognize an inherent property, function or ingredient of a prior art reference does not preclude a finding of anticipation. Atlas Powder Co. v. IRECO, Inc., 190 F.3d 1342, 1349, 51 USPQ2d 1943, 1948 (Fed. Cir. 1999) (Two prior art references disclosed blasting compositions containing water-in-oil emulsions with identical ingredients to those claimed, in overlapping ranges with the claimed composition. The only element of the claims arguably not present in the prior art compositions was “sufficient aeration… entrapped to enhance sensitivity to a substantial degree.” The Federal Circuit found that the emulsions described in both references would inevitably and inherently have “sufficient aeration” to sensitize the compound in the claimed ranges based on the evidence of record (including test data and expert testimony). This finding of inherency was not defeated by the fact that one of the references taught away from air entrapment or purposeful aeration.). See also In re King, 801 F.2d 1324, 1327, 231 USPQ 136, 139 (Fed. Cir. 1986); Titanium Metals Corp. v. Banner, 778 F.2d 775, 782, 227 USPQ 773, 778 (Fed. Cir. 1985). See MPEP § 2112 – § 2112.02 for case law on inherency. Also note that the critical date of extrinsic evidence showing a universal fact need not antedate the filing date. See MPEP § 2124.

“To serve as an anticipation when the reference is silent about the asserted inherent characteristic, such gap in the reference may be filled with recourse to extrinsic evidence. Such evidence must make clear that the missing descriptive matter is necessarily present in the thing described in the reference, and that it would be so recognized by persons of ordinary skill.” Continental Can Co. USA v. Monsanto Co., 948 F.2d 1264, 1268, 20 USPQ2d 1746, 1749-50 (Fed. Cir. 1991) (The court went on to explain that “this modest flexibility in the rule that ‘anticipation’ requires that every element of the claims appear in a single reference accommodates situations in which the common knowledge of technologists is not recorded in the reference; that is, where technological facts are known to those in the field of the invention, albeit not known to judges.” 948 F.2d at 1268, 20 USPQ at 1749-50.). Note that as long as there is evidence of record establishing inherency, failure of those skilled in the art to contemporaneously recognize an inherent property, function or ingredient of a prior art reference does not preclude a finding of anticipation. Atlas Powder Co. v. IRECO, Inc., 190 F.3d 1342, 1349, 51 USPQ2d 1943, 1948 (Fed. Cir. 1999) (Two prior art references disclosed blasting compositions containing water-in-oil emulsions with identical ingredients to those claimed, in overlapping ranges with the claimed composition. The only element of the claims arguably not present in the prior art compositions was “sufficient aeration… entrapped to enhance sensitivity to a substantial degree.” The Federal Circuit found that the emulsions described in both references would inevitably and inherently have “sufficient aeration” to sensitize the compound in the claimed ranges based on the evidence of record (including test data and expert testimony). This finding of inherency was not defeated by the fact that one of the references taught away from air entrapment or purposeful aeration.). See also In re King, 801 F.2d 1324, 1327, 231 USPQ 136, 139 (Fed. Cir. 1986); Titanium Metals Corp. v. Banner, 778 F.2d 775, 782, 227 USPQ 773, 778 (Fed. Cir. 1985). See MPEP § 2112 – § 2112.02 for case law on inherency. Also note that the critical date of extrinsic evidence showing a universal fact need not antedate the filing date. See MPEP § 2124.

When the claimed composition or machine is disclosed identically by the reference, an additional reference may be relied on to show that the primary reference has an “enabled disclosure.” In re Samour, 571 F.2d 559, 197 USPQ 1 (CCPA 1978) and In re Donohue, 766 F.2d 531, 226 USPQ 619 (Fed. Cir. 1985) (Compound claims were rejected under pre-AIA 35 U.S.C. 102(b) over a publication in view of two patents. The publication disclosed the claimed compound structure while the patents taught methods of making compounds of that general class. The applicant argued that there was no motivation to combine the references because no utility was previously known for the compound and that the 35 U.S.C. 102 rejection over multiple references was improper. The court held that the publication taught all the elements of the claim and thus motivation to combine was not required. The patents were only submitted as evidence of what was in the public's possession before the invention.).

When the claimed composition or machine is disclosed identically by the reference, an additional reference may be relied on to show that the primary reference has an “enabled disclosure.” In re Samour, 571 F.2d 559, 197 USPQ 1 (CCPA 1978) and In re Donohue, 766 F.2d 531, 226 USPQ 619 (Fed. Cir. 1985) (Compound claims were rejected under pre-AIA 35 U.S.C. 102(b) over a publication in view of two patents. The publication disclosed the claimed compound structure while the patents taught methods of making compounds of that general class. The applicant argued that there was no motivation to combine the references because no utility was previously known for the compound and that the 35 U.S.C. 102 rejection over multiple references was improper. The court held that the publication taught all the elements of the claim and thus motivation to combine was not required. The patents were only submitted as evidence of what was in the public's possession before the invention.).

In Actelion Pharmaceuticals Ltd v. Mylan Pharmaceuticals Inc., 85 F.4th 1167, 1171-74, 2023 USPQ2d 1314 (Fed. Cir. 2023), the court reviewed the intrinsic evidence including the claims, specification, and prosecution history and held that the meaning of the claim term “a pH of 13 or higher” could not be determined without turning to extrinsic evidence. It was unclear from the claims whether “a pH of 13 or higher” “carries any meaning to a person of ordinary skill in the art as regards precision of measurement, significant digits, or rounding.” Id. at 1171-1172. The specification also was unclear about any desired level of precision for the term, inconsistently describing the level of specificity for a pH of 13. Id. at 1172-1173. Finally, the prosecution history also did not illuminate a level of precision and whether “pH of 13” encompassed values that round to 13, such as 12.5. Id. at 1173. The court therefore found that in this case extrinsic evidence should be consulted to understand “the meaning of a term in the relevant art during the relevant time period”. Actelion, 85 F.4th at 1174 (quoting Teva Pharmaceuticals USA, Inc v. Sandoz, Inc., 574 U.S. 318, 331,135 S. Ct. 831, 841, 113 USPQ2d 1269, 1276 (2015)).

In Actelion Pharmaceuticals Ltd v. Mylan Pharmaceuticals Inc., 85 F.4th 1167, 1171-74, 2023 USPQ2d 1314 (Fed. Cir. 2023), the court reviewed the intrinsic evidence including the claims, specification, and prosecution history and held that the meaning of the claim term “a pH of 13 or higher” could not be determined without turning to extrinsic evidence. It was unclear from the claims whether “a pH of 13 or higher” “carries any meaning to a person of ordinary skill in the art as regards precision of measurement, significant digits, or rounding.” Id. at 1171-1172. The specification also was unclear about any desired level of precision for the term, inconsistently describing the level of specificity for a pH of 13. Id. at 1172-1173. Finally, the prosecution history also did not illuminate a level of precision and whether “pH of 13” encompassed values that round to 13, such as 12.5. Id. at 1173. The court therefore found that in this case extrinsic evidence should be consulted to understand “the meaning of a term in the relevant art during the relevant time period”. Actelion, 85 F.4th at 1174 (quoting Teva Pharmaceuticals USA, Inc v. Sandoz, Inc., 574 U.S. 318, 331,135 S. Ct. 831, 841, 113 USPQ2d 1269, 1276 (2015)).

“To serve as an anticipation when the reference is silent about the asserted inherent characteristic, such gap in the reference may be filled with recourse to extrinsic evidence. Such evidence must make clear that the missing descriptive matter is necessarily present in the thing described in the reference, and that it would be so recognized by persons of ordinary skill.” Continental Can Co. USA v. Monsanto Co., 948 F.2d 1264, 1268, 20 USPQ2d 1746, 1749-50 (Fed. Cir. 1991) (The court went on to explain that “this modest flexibility in the rule that ‘anticipation’ requires that every element of the claims appear in a single reference accommodates situations in which the common knowledge of technologists is not recorded in the reference; that is, where technological facts are known to those in the field of the invention, albeit not known to judges.” 948 F.2d at 1268, 20 USPQ at 1749-50.). Note that as long as there is evidence of record establishing inherency, failure of those skilled in the art to contemporaneously recognize an inherent property, function or ingredient of a prior art reference does not preclude a finding of anticipation. Atlas Powder Co. v. IRECO, Inc., 190 F.3d 1342, 1349, 51 USPQ2d 1943, 1948 (Fed. Cir. 1999) (Two prior art references disclosed blasting compositions containing water-in-oil emulsions with identical ingredients to those claimed, in overlapping ranges with the claimed composition. The only element of the claims arguably not present in the prior art compositions was “sufficient aeration… entrapped to enhance sensitivity to a substantial degree.” The Federal Circuit found that the emulsions described in both references would inevitably and inherently have “sufficient aeration” to sensitize the compound in the claimed ranges based on the evidence of record (including test data and expert testimony). This finding of inherency was not defeated by the fact that one of the references taught away from air entrapment or purposeful aeration.). See also In re King, 801 F.2d 1324, 1327, 231 USPQ 136, 139 (Fed. Cir. 1986); Titanium Metals Corp. v. Banner, 778 F.2d 775, 782, 227 USPQ 773, 778 (Fed. Cir. 1985). See MPEP § 2112 – § 2112.02 for case law on inherency. Also note that the critical date of extrinsic evidence showing a universal fact need not antedate the filing date. See MPEP § 2124.

“To serve as an anticipation when the reference is silent about the asserted inherent characteristic, such gap in the reference may be filled with recourse to extrinsic evidence. Such evidence must make clear that the missing descriptive matter is necessarily present in the thing described in the reference, and that it would be so recognized by persons of ordinary skill.” Continental Can Co. USA v. Monsanto Co., 948 F.2d 1264, 1268, 20 USPQ2d 1746, 1749-50 (Fed. Cir. 1991) (The court went on to explain that “this modest flexibility in the rule that ‘anticipation’ requires that every element of the claims appear in a single reference accommodates situations in which the common knowledge of technologists is not recorded in the reference; that is, where technological facts are known to those in the field of the invention, albeit not known to judges.” 948 F.2d at 1268, 20 USPQ at 1749-50.). Note that as long as there is evidence of record establishing inherency, failure of those skilled in the art to contemporaneously recognize an inherent property, function or ingredient of a prior art reference does not preclude a finding of anticipation. Atlas Powder Co. v. IRECO, Inc., 190 F.3d 1342, 1349, 51 USPQ2d 1943, 1948 (Fed. Cir. 1999) (Two prior art references disclosed blasting compositions containing water-in-oil emulsions with identical ingredients to those claimed, in overlapping ranges with the claimed composition. The only element of the claims arguably not present in the prior art compositions was “sufficient aeration… entrapped to enhance sensitivity to a substantial degree.” The Federal Circuit found that the emulsions described in both references would inevitably and inherently have “sufficient aeration” to sensitize the compound in the claimed ranges based on the evidence of record (including test data and expert testimony). This finding of inherency was not defeated by the fact that one of the references taught away from air entrapment or purposeful aeration.). See also In re King, 801 F.2d 1324, 1327, 231 USPQ 136, 139 (Fed. Cir. 1986); Titanium Metals Corp. v. Banner, 778 F.2d 775, 782, 227 USPQ 773, 778 (Fed. Cir. 1985). See MPEP § 2112 – § 2112.02 for case law on inherency. Also note that the critical date of extrinsic evidence showing a universal fact need not antedate the filing date. See MPEP § 2124.

“To serve as an anticipation when the reference is silent about the asserted inherent characteristic, such gap in the reference may be filled with recourse to extrinsic evidence. Such evidence must make clear that the missing descriptive matter is necessarily present in the thing described in the reference, and that it would be so recognized by persons of ordinary skill.” Continental Can Co. USA v. Monsanto Co., 948 F.2d 1264, 1268, 20 USPQ2d 1746, 1749-50 (Fed. Cir. 1991) (The court went on to explain that “this modest flexibility in the rule that ‘anticipation’ requires that every element of the claims appear in a single reference accommodates situations in which the common knowledge of technologists is not recorded in the reference; that is, where technological facts are known to those in the field of the invention, albeit not known to judges.” 948 F.2d at 1268, 20 USPQ at 1749-50.). Note that as long as there is evidence of record establishing inherency, failure of those skilled in the art to contemporaneously recognize an inherent property, function or ingredient of a prior art reference does not preclude a finding of anticipation. Atlas Powder Co. v. IRECO, Inc., 190 F.3d 1342, 1349, 51 USPQ2d 1943, 1948 (Fed. Cir. 1999) (Two prior art references disclosed blasting compositions containing water-in-oil emulsions with identical ingredients to those claimed, in overlapping ranges with the claimed composition. The only element of the claims arguably not present in the prior art compositions was “sufficient aeration… entrapped to enhance sensitivity to a substantial degree.” The Federal Circuit found that the emulsions described in both references would inevitably and inherently have “sufficient aeration” to sensitize the compound in the claimed ranges based on the evidence of record (including test data and expert testimony). This finding of inherency was not defeated by the fact that one of the references taught away from air entrapment or purposeful aeration.). See also In re King, 801 F.2d 1324, 1327, 231 USPQ 136, 139 (Fed. Cir. 1986); Titanium Metals Corp. v. Banner, 778 F.2d 775, 782, 227 USPQ 773, 778 (Fed. Cir. 1985). See MPEP § 2112 – § 2112.02 for case law on inherency. Also note that the critical date of extrinsic evidence showing a universal fact need not antedate the filing date. See MPEP § 2124.