MPEP § 2163.03 — Typical Circumstances Where Adequate Written Description Issue Arises (Annotated Rules)
§2163.03 Typical Circumstances Where Adequate Written Description Issue Arises
This page consolidates and annotates all enforceable requirements under MPEP § 2163.03, including statutory authority, regulatory rules, examiner guidance, and practice notes. It is provided as guidance, with links to the ground truth sources. This is information only, it is not legal advice.
Typical Circumstances Where Adequate Written Description Issue Arises
This section addresses Typical Circumstances Where Adequate Written Description Issue Arises. Primary authority: 35 U.S.C. 120, 35 U.S.C. 112(a), and 35 U.S.C. 112. Contains: 1 requirement, 1 permission, and 13 other statements.
Key Rules
PTAB Jurisdiction
Under 35 U.S.C. 120, the claims in a U.S. application are entitled to the benefit of the filing date of an earlier filed U.S. application if the subject matter of the claim is disclosed in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph in the earlier filed application. See, e.g., Tronzo v. Biomet, Inc., 156 F.3d 1154, 47 USPQ2d 1829 (Fed. Cir. 1998); In re Scheiber, 587 F.2d 59, 199 USPQ 782 (CCPA 1978). See also Regents of the Univ. of Minnesota v. Gilead Scis., Inc., 61 F.4th 1350, 2023 USPQ2d 269 (Fed. Cir. 2023). The court noted that the Board evaluated whether the earlier- filed applications provided an “ ipsis verbis ” disclosure of the claimed subgenus. In reviewing this evaluation, the court agreed with the Board that the earlier-filed applications recited a compendium of common organic chemical functional groups, yielding a laundry list disclosure of different moieties for every possible side chain or functional group. Id. at 1357. Thus, it was unclear how many compounds actually fell within the described genera and subgenera. Id. The court also noted that the Board then evaluated whether the prior applications “provided sufficient blaze marks to provide written description support for the ‘830 patent claims.” Id. at 1357. The court agreed with the Board that there were no adequate blaze marks. Id. at 1358. Therefore, the court held that the earlier-filed applications did not provide sufficient written description to support the later-filed patent claims under 35 U.S.C. 120.
Under 35 U.S.C. 120, the claims in a U.S. application are entitled to the benefit of the filing date of an earlier filed U.S. application if the subject matter of the claim is disclosed in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph in the earlier filed application. See, e.g., Tronzo v. Biomet, Inc., 156 F.3d 1154, 47 USPQ2d 1829 (Fed. Cir. 1998); In re Scheiber, 587 F.2d 59, 199 USPQ 782 (CCPA 1978). See also Regents of the Univ. of Minnesota v. Gilead Scis., Inc., 61 F.4th 1350, 2023 USPQ2d 269 (Fed. Cir. 2023). The court noted that the Board evaluated whether the earlier- filed applications provided an “ ipsis verbis ” disclosure of the claimed subgenus. In reviewing this evaluation, the court agreed with the Board that the earlier-filed applications recited a compendium of common organic chemical functional groups, yielding a laundry list disclosure of different moieties for every possible side chain or functional group. Id. at 1357. Thus, it was unclear how many compounds actually fell within the described genera and subgenera. Id. The court also noted that the Board then evaluated whether the prior applications “provided sufficient blaze marks to provide written description support for the ‘830 patent claims.” Id. at 1357. The court agreed with the Board that there were no adequate blaze marks. Id. at 1358. Therefore, the court held that the earlier-filed applications did not provide sufficient written description to support the later-filed patent claims under 35 U.S.C. 120.
Under 35 U.S.C. 120, the claims in a U.S. application are entitled to the benefit of the filing date of an earlier filed U.S. application if the subject matter of the claim is disclosed in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph in the earlier filed application. See, e.g., Tronzo v. Biomet, Inc., 156 F.3d 1154, 47 USPQ2d 1829 (Fed. Cir. 1998); In re Scheiber, 587 F.2d 59, 199 USPQ 782 (CCPA 1978). See also Regents of the Univ. of Minnesota v. Gilead Scis., Inc., 61 F.4th 1350, 2023 USPQ2d 269 (Fed. Cir. 2023). The court noted that the Board evaluated whether the earlier- filed applications provided an “ ipsis verbis ” disclosure of the claimed subgenus. In reviewing this evaluation, the court agreed with the Board that the earlier-filed applications recited a compendium of common organic chemical functional groups, yielding a laundry list disclosure of different moieties for every possible side chain or functional group. Id. at 1357. Thus, it was unclear how many compounds actually fell within the described genera and subgenera. Id. The court also noted that the Board then evaluated whether the prior applications “provided sufficient blaze marks to provide written description support for the ‘830 patent claims.” Id. at 1357. The court agreed with the Board that there were no adequate blaze marks. Id. at 1358. Therefore, the court held that the earlier-filed applications did not provide sufficient written description to support the later-filed patent claims under 35 U.S.C. 120.
Under 35 U.S.C. 120, the claims in a U.S. application are entitled to the benefit of the filing date of an earlier filed U.S. application if the subject matter of the claim is disclosed in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph in the earlier filed application. See, e.g., Tronzo v. Biomet, Inc., 156 F.3d 1154, 47 USPQ2d 1829 (Fed. Cir. 1998); In re Scheiber, 587 F.2d 59, 199 USPQ 782 (CCPA 1978). See also Regents of the Univ. of Minnesota v. Gilead Scis., Inc., 61 F.4th 1350, 2023 USPQ2d 269 (Fed. Cir. 2023). The court noted that the Board evaluated whether the earlier- filed applications provided an “ ipsis verbis ” disclosure of the claimed subgenus. In reviewing this evaluation, the court agreed with the Board that the earlier-filed applications recited a compendium of common organic chemical functional groups, yielding a laundry list disclosure of different moieties for every possible side chain or functional group. Id. at 1357. Thus, it was unclear how many compounds actually fell within the described genera and subgenera. Id. The court also noted that the Board then evaluated whether the prior applications “provided sufficient blaze marks to provide written description support for the ‘830 patent claims.” Id. at 1357. The court agreed with the Board that there were no adequate blaze marks. Id. at 1358. Therefore, the court held that the earlier-filed applications did not provide sufficient written description to support the later-filed patent claims under 35 U.S.C. 120.
Under 35 U.S.C. 120, the claims in a U.S. application are entitled to the benefit of the filing date of an earlier filed U.S. application if the subject matter of the claim is disclosed in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph in the earlier filed application. See, e.g., Tronzo v. Biomet, Inc., 156 F.3d 1154, 47 USPQ2d 1829 (Fed. Cir. 1998); In re Scheiber, 587 F.2d 59, 199 USPQ 782 (CCPA 1978). See also Regents of the Univ. of Minnesota v. Gilead Scis., Inc., 61 F.4th 1350, 2023 USPQ2d 269 (Fed. Cir. 2023). The court noted that the Board evaluated whether the earlier- filed applications provided an “ ipsis verbis ” disclosure of the claimed subgenus. In reviewing this evaluation, the court agreed with the Board that the earlier-filed applications recited a compendium of common organic chemical functional groups, yielding a laundry list disclosure of different moieties for every possible side chain or functional group. Id. at 1357. Thus, it was unclear how many compounds actually fell within the described genera and subgenera. Id. The court also noted that the Board then evaluated whether the prior applications “provided sufficient blaze marks to provide written description support for the ‘830 patent claims.” Id. at 1357. The court agreed with the Board that there were no adequate blaze marks. Id. at 1358. Therefore, the court held that the earlier-filed applications did not provide sufficient written description to support the later-filed patent claims under 35 U.S.C. 120.
Under 35 U.S.C. 120, the claims in a U.S. application are entitled to the benefit of the filing date of an earlier filed U.S. application if the subject matter of the claim is disclosed in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph in the earlier filed application. See, e.g., Tronzo v. Biomet, Inc., 156 F.3d 1154, 47 USPQ2d 1829 (Fed. Cir. 1998); In re Scheiber, 587 F.2d 59, 199 USPQ 782 (CCPA 1978). See also Regents of the Univ. of Minnesota v. Gilead Scis., Inc., 61 F.4th 1350, 2023 USPQ2d 269 (Fed. Cir. 2023). The court noted that the Board evaluated whether the earlier- filed applications provided an “ ipsis verbis ” disclosure of the claimed subgenus. In reviewing this evaluation, the court agreed with the Board that the earlier-filed applications recited a compendium of common organic chemical functional groups, yielding a laundry list disclosure of different moieties for every possible side chain or functional group. Id. at 1357. Thus, it was unclear how many compounds actually fell within the described genera and subgenera. Id. The court also noted that the Board then evaluated whether the prior applications “provided sufficient blaze marks to provide written description support for the ‘830 patent claims.” Id. at 1357. The court agreed with the Board that there were no adequate blaze marks. Id. at 1358. Therefore, the court held that the earlier-filed applications did not provide sufficient written description to support the later-filed patent claims under 35 U.S.C. 120.
Under 35 U.S.C. 120, the claims in a U.S. application are entitled to the benefit of the filing date of an earlier filed U.S. application if the subject matter of the claim is disclosed in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph in the earlier filed application. See, e.g., Tronzo v. Biomet, Inc., 156 F.3d 1154, 47 USPQ2d 1829 (Fed. Cir. 1998); In re Scheiber, 587 F.2d 59, 199 USPQ 782 (CCPA 1978). See also Regents of the Univ. of Minnesota v. Gilead Scis., Inc., 61 F.4th 1350, 2023 USPQ2d 269 (Fed. Cir. 2023). The court noted that the Board evaluated whether the earlier- filed applications provided an “ ipsis verbis ” disclosure of the claimed subgenus. In reviewing this evaluation, the court agreed with the Board that the earlier-filed applications recited a compendium of common organic chemical functional groups, yielding a laundry list disclosure of different moieties for every possible side chain or functional group. Id. at 1357. Thus, it was unclear how many compounds actually fell within the described genera and subgenera. Id. The court also noted that the Board then evaluated whether the prior applications “provided sufficient blaze marks to provide written description support for the ‘830 patent claims.” Id. at 1357. The court agreed with the Board that there were no adequate blaze marks. Id. at 1358. Therefore, the court held that the earlier-filed applications did not provide sufficient written description to support the later-filed patent claims under 35 U.S.C. 120.
Under 35 U.S.C. 120, the claims in a U.S. application are entitled to the benefit of the filing date of an earlier filed U.S. application if the subject matter of the claim is disclosed in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph in the earlier filed application. See, e.g., Tronzo v. Biomet, Inc., 156 F.3d 1154, 47 USPQ2d 1829 (Fed. Cir. 1998); In re Scheiber, 587 F.2d 59, 199 USPQ 782 (CCPA 1978). See also Regents of the Univ. of Minnesota v. Gilead Scis., Inc., 61 F.4th 1350, 2023 USPQ2d 269 (Fed. Cir. 2023). The court noted that the Board evaluated whether the earlier- filed applications provided an “ ipsis verbis ” disclosure of the claimed subgenus. In reviewing this evaluation, the court agreed with the Board that the earlier-filed applications recited a compendium of common organic chemical functional groups, yielding a laundry list disclosure of different moieties for every possible side chain or functional group. Id. at 1357. Thus, it was unclear how many compounds actually fell within the described genera and subgenera. Id. The court also noted that the Board then evaluated whether the prior applications “provided sufficient blaze marks to provide written description support for the ‘830 patent claims.” Id. at 1357. The court agreed with the Board that there were no adequate blaze marks. Id. at 1358. Therefore, the court held that the earlier-filed applications did not provide sufficient written description to support the later-filed patent claims under 35 U.S.C. 120.
Under 35 U.S.C. 120, the claims in a U.S. application are entitled to the benefit of the filing date of an earlier filed U.S. application if the subject matter of the claim is disclosed in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph in the earlier filed application. See, e.g., Tronzo v. Biomet, Inc., 156 F.3d 1154, 47 USPQ2d 1829 (Fed. Cir. 1998); In re Scheiber, 587 F.2d 59, 199 USPQ 782 (CCPA 1978). See also Regents of the Univ. of Minnesota v. Gilead Scis., Inc., 61 F.4th 1350, 2023 USPQ2d 269 (Fed. Cir. 2023). The court noted that the Board evaluated whether the earlier- filed applications provided an “ ipsis verbis ” disclosure of the claimed subgenus. In reviewing this evaluation, the court agreed with the Board that the earlier-filed applications recited a compendium of common organic chemical functional groups, yielding a laundry list disclosure of different moieties for every possible side chain or functional group. Id. at 1357. Thus, it was unclear how many compounds actually fell within the described genera and subgenera. Id. The court also noted that the Board then evaluated whether the prior applications “provided sufficient blaze marks to provide written description support for the ‘830 patent claims.” Id. at 1357. The court agreed with the Board that there were no adequate blaze marks. Id. at 1358. Therefore, the court held that the earlier-filed applications did not provide sufficient written description to support the later-filed patent claims under 35 U.S.C. 120.
Written Description Requirement (MPEP 2163)
Under 35 U.S.C. 119(a) or (e), the claims in a U.S. application are entitled to the benefit of a foreign priority date or the filing date of a provisional application if the corresponding foreign application or provisional application supports the claims in the manner required by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph. Purdue Pharma LP v. Iancu, 767 Fed. Appx. 918, 923-24, 2019 USPQ2d 136363 (Fed. Cir. 2019); In re Ziegler, 992 F.2d 1197, 1200, 26 USPQ2d 1600, 1603 (Fed. Cir. 1993); Kawai v. Metlesics, 480 F.2d 880, 178 USPQ 158 (CCPA 1973); In re Gosteli, 872 F.2d 1008, 10 USPQ2d 1614 (Fed. Cir. 1989).
In an interference proceeding, the claim corresponding to a count must be supported by the specification in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph. Fields v. Conover, 443 F.2d 1386, 170 USPQ 276 (CCPA 1971) (A broad generic disclosure to a class of compounds was not a sufficient written description of a specific compound within the class.). Furthermore, when a party to an interference seeks the benefit of an earlier-filed U.S. patent application, the earlier application must meet the requirements of 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for the subject matter of the count. Hyatt v. Boone, 146 F.3d 1348, 1352, 47 USPQ2d 1128, 1130 (Fed. Cir. 1998).
A claim limitation expressed in means- (or step-) plus-function language “shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.” 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. If the specification fails to disclose sufficient corresponding structure, materials, or acts that perform the entire claimed function, then the claim limitation is indefinite because the applicant has in effect failed to particularly point out and distinctly claim the invention as required by 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. In re Donaldson Co., 16 F.3d 1189, 1195, 29 USPQ2d 1845, 1850 (Fed. Cir. 1994) (en banc). Such a limitation also lacks an adequate written description as required by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, because an indefinite, unbounded functional limitation would cover all ways of performing a function and indicate that the inventor has not provided sufficient disclosure to show possession of the invention. See also MPEP § 2181.
Claim Form Requirements
While there is a presumption that an adequate written description of the claimed invention is present in the specification as filed. In re Wertheim, 541 F.2d 257, 262, 191 USPQ 90, 96 (CCPA 1976), a question as to whether a specification provides an adequate written description may arise in the context of an original claim. An original claim may lack written description support when (1) the claim defines the invention in functional language specifying a desired result but the disclosure fails to sufficiently identify how the function is performed or the result is achieved or (2) a broad genus claim is presented but the disclosure only describes a narrow species with no evidence that the genus is contemplated. See Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1349-50 (Fed. Cir. 2010) (en banc). The written description requirement is not necessarily met when the claim language appears in ipsis verbis in the specification. “Even if a claim is supported by the specification, the language of the specification, to the extent possible, must describe the claimed invention so that one skilled in the art can recognize what is claimed. The appearance of mere indistinct words in a specification or a claim, even an original claim, does not necessarily satisfy that requirement.” Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956, 968, 63 USPQ2d 1609, 1616 (Fed. Cir. 2002).
While there is a presumption that an adequate written description of the claimed invention is present in the specification as filed. In re Wertheim, 541 F.2d 257, 262, 191 USPQ 90, 96 (CCPA 1976), a question as to whether a specification provides an adequate written description may arise in the context of an original claim. An original claim may lack written description support when (1) the claim defines the invention in functional language specifying a desired result but the disclosure fails to sufficiently identify how the function is performed or the result is achieved or (2) a broad genus claim is presented but the disclosure only describes a narrow species with no evidence that the genus is contemplated. See Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1349-50 (Fed. Cir. 2010) (en banc). The written description requirement is not necessarily met when the claim language appears in ipsis verbis in the specification. “Even if a claim is supported by the specification, the language of the specification, to the extent possible, must describe the claimed invention so that one skilled in the art can recognize what is claimed. The appearance of mere indistinct words in a specification or a claim, even an original claim, does not necessarily satisfy that requirement.” Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956, 968, 63 USPQ2d 1609, 1616 (Fed. Cir. 2002).
While there is a presumption that an adequate written description of the claimed invention is present in the specification as filed. In re Wertheim, 541 F.2d 257, 262, 191 USPQ 90, 96 (CCPA 1976), a question as to whether a specification provides an adequate written description may arise in the context of an original claim. An original claim may lack written description support when (1) the claim defines the invention in functional language specifying a desired result but the disclosure fails to sufficiently identify how the function is performed or the result is achieved or (2) a broad genus claim is presented but the disclosure only describes a narrow species with no evidence that the genus is contemplated. See Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1349-50 (Fed. Cir. 2010) (en banc). The written description requirement is not necessarily met when the claim language appears in ipsis verbis in the specification. “Even if a claim is supported by the specification, the language of the specification, to the extent possible, must describe the claimed invention so that one skilled in the art can recognize what is claimed. The appearance of mere indistinct words in a specification or a claim, even an original claim, does not necessarily satisfy that requirement.” Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956, 968, 63 USPQ2d 1609, 1616 (Fed. Cir. 2002).
Original Claims and New Matter
While there is a presumption that an adequate written description of the claimed invention is present in the specification as filed. In re Wertheim, 541 F.2d 257, 262, 191 USPQ 90, 96 (CCPA 1976), a question as to whether a specification provides an adequate written description may arise in the context of an original claim. An original claim may lack written description support when (1) the claim defines the invention in functional language specifying a desired result but the disclosure fails to sufficiently identify how the function is performed or the result is achieved or (2) a broad genus claim is presented but the disclosure only describes a narrow species with no evidence that the genus is contemplated. See Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1349-50 (Fed. Cir. 2010) (en banc). The written description requirement is not necessarily met when the claim language appears in ipsis verbis in the specification. “Even if a claim is supported by the specification, the language of the specification, to the extent possible, must describe the claimed invention so that one skilled in the art can recognize what is claimed. The appearance of mere indistinct words in a specification or a claim, even an original claim, does not necessarily satisfy that requirement.” Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956, 968, 63 USPQ2d 1609, 1616 (Fed. Cir. 2002).
While there is a presumption that an adequate written description of the claimed invention is present in the specification as filed. In re Wertheim, 541 F.2d 257, 262, 191 USPQ 90, 96 (CCPA 1976), a question as to whether a specification provides an adequate written description may arise in the context of an original claim. An original claim may lack written description support when (1) the claim defines the invention in functional language specifying a desired result but the disclosure fails to sufficiently identify how the function is performed or the result is achieved or (2) a broad genus claim is presented but the disclosure only describes a narrow species with no evidence that the genus is contemplated. See Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1349-50 (Fed. Cir. 2010) (en banc). The written description requirement is not necessarily met when the claim language appears in ipsis verbis in the specification. “Even if a claim is supported by the specification, the language of the specification, to the extent possible, must describe the claimed invention so that one skilled in the art can recognize what is claimed. The appearance of mere indistinct words in a specification or a claim, even an original claim, does not necessarily satisfy that requirement.” Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956, 968, 63 USPQ2d 1609, 1616 (Fed. Cir. 2002).
Claims
While there is a presumption that an adequate written description of the claimed invention is present in the specification as filed. In re Wertheim, 541 F.2d 257, 262, 191 USPQ 90, 96 (CCPA 1976), a question as to whether a specification provides an adequate written description may arise in the context of an original claim. An original claim may lack written description support when (1) the claim defines the invention in functional language specifying a desired result but the disclosure fails to sufficiently identify how the function is performed or the result is achieved or (2) a broad genus claim is presented but the disclosure only describes a narrow species with no evidence that the genus is contemplated. See Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1349-50 (Fed. Cir. 2010) (en banc). The written description requirement is not necessarily met when the claim language appears in ipsis verbis in the specification. “Even if a claim is supported by the specification, the language of the specification, to the extent possible, must describe the claimed invention so that one skilled in the art can recognize what is claimed. The appearance of mere indistinct words in a specification or a claim, even an original claim, does not necessarily satisfy that requirement.” Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956, 968, 63 USPQ2d 1609, 1616 (Fed. Cir. 2002).
An amendment to the claims or the addition of a new claim must be supported by the description of the invention in the application as filed. In re Wright, 866 F.2d 422, 9 USPQ2d 1649 (Fed. Cir. 1989). An amendment to the specification (e.g., a change in the definition of a term used both in the specification and claim) may indirectly affect a claim even though no actual amendment is made to the claim.
Alternative Limitations (MPEP 2173.05(h))
A claim limitation expressed in means- (or step-) plus-function language “shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.” 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. If the specification fails to disclose sufficient corresponding structure, materials, or acts that perform the entire claimed function, then the claim limitation is indefinite because the applicant has in effect failed to particularly point out and distinctly claim the invention as required by 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. In re Donaldson Co., 16 F.3d 1189, 1195, 29 USPQ2d 1845, 1850 (Fed. Cir. 1994) (en banc). Such a limitation also lacks an adequate written description as required by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, because an indefinite, unbounded functional limitation would cover all ways of performing a function and indicate that the inventor has not provided sufficient disclosure to show possession of the invention. See also MPEP § 2181.
A claim limitation expressed in means- (or step-) plus-function language “shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.” 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. If the specification fails to disclose sufficient corresponding structure, materials, or acts that perform the entire claimed function, then the claim limitation is indefinite because the applicant has in effect failed to particularly point out and distinctly claim the invention as required by 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. In re Donaldson Co., 16 F.3d 1189, 1195, 29 USPQ2d 1845, 1850 (Fed. Cir. 1994) (en banc). Such a limitation also lacks an adequate written description as required by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, because an indefinite, unbounded functional limitation would cover all ways of performing a function and indicate that the inventor has not provided sufficient disclosure to show possession of the invention. See also MPEP § 2181.
Foreign Priority Claims
Under 35 U.S.C. 119(a) or (e), the claims in a U.S. application are entitled to the benefit of a foreign priority date or the filing date of a provisional application if the corresponding foreign application or provisional application supports the claims in the manner required by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph. Purdue Pharma LP v. Iancu, 767 Fed. Appx. 918, 923-24, 2019 USPQ2d 136363 (Fed. Cir. 2019); In re Ziegler, 992 F.2d 1197, 1200, 26 USPQ2d 1600, 1603 (Fed. Cir. 1993); Kawai v. Metlesics, 480 F.2d 880, 178 USPQ 158 (CCPA 1973); In re Gosteli, 872 F.2d 1008, 10 USPQ2d 1614 (Fed. Cir. 1989).
Optional Claim Content
While there is a presumption that an adequate written description of the claimed invention is present in the specification as filed. In re Wertheim, 541 F.2d 257, 262, 191 USPQ 90, 96 (CCPA 1976), a question as to whether a specification provides an adequate written description may arise in the context of an original claim. An original claim may lack written description support when (1) the claim defines the invention in functional language specifying a desired result but the disclosure fails to sufficiently identify how the function is performed or the result is achieved or (2) a broad genus claim is presented but the disclosure only describes a narrow species with no evidence that the genus is contemplated. See Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1349-50 (Fed. Cir. 2010) (en banc). The written description requirement is not necessarily met when the claim language appears in ipsis verbis in the specification. “Even if a claim is supported by the specification, the language of the specification, to the extent possible, must describe the claimed invention so that one skilled in the art can recognize what is claimed. The appearance of mere indistinct words in a specification or a claim, even an original claim, does not necessarily satisfy that requirement.” Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956, 968, 63 USPQ2d 1609, 1616 (Fed. Cir. 2002).
Missing Information – Enablement (MPEP 2164.06(a))
A claim limitation expressed in means- (or step-) plus-function language “shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.” 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. If the specification fails to disclose sufficient corresponding structure, materials, or acts that perform the entire claimed function, then the claim limitation is indefinite because the applicant has in effect failed to particularly point out and distinctly claim the invention as required by 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. In re Donaldson Co., 16 F.3d 1189, 1195, 29 USPQ2d 1845, 1850 (Fed. Cir. 1994) (en banc). Such a limitation also lacks an adequate written description as required by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, because an indefinite, unbounded functional limitation would cover all ways of performing a function and indicate that the inventor has not provided sufficient disclosure to show possession of the invention. See also MPEP § 2181.
Possession of the Invention (MPEP 2163.02)
A claim limitation expressed in means- (or step-) plus-function language “shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.” 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. If the specification fails to disclose sufficient corresponding structure, materials, or acts that perform the entire claimed function, then the claim limitation is indefinite because the applicant has in effect failed to particularly point out and distinctly claim the invention as required by 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. In re Donaldson Co., 16 F.3d 1189, 1195, 29 USPQ2d 1845, 1850 (Fed. Cir. 1994) (en banc). Such a limitation also lacks an adequate written description as required by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, because an indefinite, unbounded functional limitation would cover all ways of performing a function and indicate that the inventor has not provided sufficient disclosure to show possession of the invention. See also MPEP § 2181.
Adding New Claims
An amendment to the claims or the addition of a new claim must be supported by the description of the invention in the application as filed. In re Wright, 866 F.2d 422, 9 USPQ2d 1649 (Fed. Cir. 1989). An amendment to the specification (e.g., a change in the definition of a term used both in the specification and claim) may indirectly affect a claim even though no actual amendment is made to the claim.
Citations
| Primary topic | Citation |
|---|---|
| Alternative Limitations (MPEP 2173.05(h)) Foreign Priority Claims Missing Information – Enablement (MPEP 2164.06(a)) PTAB Jurisdiction Possession of the Invention (MPEP 2163.02) Written Description Requirement (MPEP 2163) | 35 U.S.C. § 112 |
| Alternative Limitations (MPEP 2173.05(h)) Foreign Priority Claims Missing Information – Enablement (MPEP 2164.06(a)) PTAB Jurisdiction Possession of the Invention (MPEP 2163.02) Written Description Requirement (MPEP 2163) | 35 U.S.C. § 112(a) |
| Alternative Limitations (MPEP 2173.05(h)) Missing Information – Enablement (MPEP 2164.06(a)) Possession of the Invention (MPEP 2163.02) Written Description Requirement (MPEP 2163) | 35 U.S.C. § 112(b) |
| Alternative Limitations (MPEP 2173.05(h)) Missing Information – Enablement (MPEP 2164.06(a)) Possession of the Invention (MPEP 2163.02) Written Description Requirement (MPEP 2163) | 35 U.S.C. § 112(f) |
| Foreign Priority Claims Written Description Requirement (MPEP 2163) | 35 U.S.C. § 119(a) |
| PTAB Jurisdiction | 35 U.S.C. § 120 |
| – | MPEP § 2163 |
| Alternative Limitations (MPEP 2173.05(h)) Missing Information – Enablement (MPEP 2164.06(a)) Possession of the Invention (MPEP 2163.02) Written Description Requirement (MPEP 2163) | MPEP § 2181 |
| Claim Form Requirements Claims Optional Claim Content Original Claims and New Matter | Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956, 968, 63 USPQ2d 1609, 1616 (Fed. Cir. 2002) |
| Written Description Requirement (MPEP 2163) | Fields v. Conover, 443 F.2d 1386, 170 USPQ 276 (CCPA 1971) |
| Written Description Requirement (MPEP 2163) | Hyatt v. Boone, 146 F.3d 1348, 1352, 47 USPQ2d 1128, 1130 (Fed. Cir. 1998) |
| Foreign Priority Claims Written Description Requirement (MPEP 2163) | In re Gosteli, 872 F.2d 1008, 10 USPQ2d 1614 (Fed. Cir. 1989) |
| PTAB Jurisdiction | In re Scheiber, 587 F.2d 59, 199 USPQ 782 (CCPA 1978) |
| Claim Form Requirements Claims Optional Claim Content Original Claims and New Matter | In re Wertheim, 541 F.2d 257, 262, 191 USPQ 90, 96 (CCPA 1976) |
| Adding New Claims Claims | In re Wright, 866 F.2d 422, 9 USPQ2d 1649 (Fed. Cir. 1989) |
| Foreign Priority Claims Written Description Requirement (MPEP 2163) | In re Ziegler, 992 F.2d 1197, 1200, 26 USPQ2d 1600, 1603 (Fed. Cir. 1993) |
| Foreign Priority Claims Written Description Requirement (MPEP 2163) | Kawai v. Metlesics, 480 F.2d 880, 178 USPQ 158 (CCPA 1973) |
| PTAB Jurisdiction | Tronzo v. Biomet, Inc., 156 F.3d 1154, 47 USPQ2d 1829 (Fed. Cir. 1998) |
Source Text from USPTO’s MPEP
This is an exact copy of the MPEP from the USPTO. It is here for your reference to see the section in context.
Official MPEP § 2163.03 — Typical Circumstances Where Adequate Written Description Issue Arises
Source: USPTO2163.03 Typical Circumstances Where Adequate Written Description Issue Arises [R-01.2024]
A description requirement issue can arise in a number of different circumstances where it must be determined whether the subject matter of a claim is supported in an application as filed. See MPEP § 2163 for examination guidelines pertaining to the written description requirement. Most typically, the issue will arise in the following circumstances:
I. AMENDMENT AFFECTING A CLAIMAn amendment to the claims or the addition of a new claim must be supported by the description of the invention in the application as filed. In reWright, 866 F.2d 422, 9 USPQ2d 1649 (Fed. Cir. 1989). An amendment to the specification (e.g., a change in the definition of a term used both in the specification and claim) may indirectly affect a claim even though no actual amendment is made to the claim.
II. RELIANCE ON FILING DATE OF PARENT APPLICATION UNDER 35 U.S.C. 120Under 35 U.S.C. 120, the claims in a U.S. application are entitled to the benefit of the filing date of an earlier filed U.S. application if the subject matter of the claim is disclosed in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph in the earlier filed application. See, e.g., Tronzo v. Biomet, Inc., 156 F.3d 1154, 47 USPQ2d 1829 (Fed. Cir. 1998); In reScheiber, 587 F.2d 59, 199 USPQ 782 (CCPA 1978). See also Regents of the Univ. of Minnesota v. Gilead Scis., Inc., 61 F.4th 1350, 2023 USPQ2d 269 (Fed. Cir. 2023). The court noted that the Board evaluated whether the earlier- filed applications provided an “ipsis verbis” disclosure of the claimed subgenus. In reviewing this evaluation, the court agreed with the Board that the earlier-filed applications recited a compendium of common organic chemical functional groups, yielding a laundry list disclosure of different moieties for every possible side chain or functional group. Id. at 1357. Thus, it was unclear how many compounds actually fell within the described genera and subgenera. Id. The court also noted that the Board then evaluated whether the prior applications “provided sufficient blaze marks to provide written description support for the ‘830 patent claims.” Id. at 1357. The court agreed with the Board that there were no adequate blaze marks. Id. at 1358. Therefore, the court held that the earlier-filed applications did not provide sufficient written description to support the later-filed patent claims under 35 U.S.C. 120.
III. RELIANCE ON PRIORITY UNDER 35 U.S.C. 119Under 35 U.S.C. 119(a) or (e), the claims in a U.S. application are entitled to the benefit of a foreign priority date or the filing date of a provisional application if the corresponding foreign application or provisional application supports the claims in the manner required by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph. Purdue Pharma LP v. Iancu, 767 Fed. Appx. 918, 923-24, 2019 USPQ2d 136363 (Fed. Cir. 2019); In reZiegler, 992 F.2d 1197, 1200, 26 USPQ2d 1600, 1603 (Fed. Cir. 1993); Kawaiv.Metlesics, 480 F.2d 880, 178 USPQ 158 (CCPA 1973); In reGosteli, 872 F.2d 1008, 10 USPQ2d 1614 (Fed. Cir. 1989).
IV. SUPPORT FOR A CLAIM CORRESPONDING TO A COUNT IN AN INTERFERENCEIn an interference proceeding, the claim corresponding to a count must be supported by the specification in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph. Fields v. Conover, 443 F.2d 1386, 170 USPQ 276 (CCPA 1971) (A broad generic disclosure to a class of compounds was not a sufficient written description of a specific compound within the class.). Furthermore, when a party to an interference seeks the benefit of an earlier-filed U.S. patent application, the earlier application must meet the requirements of 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for the subject matter of the count. Hyatt v. Boone, 146 F.3d 1348, 1352, 47 USPQ2d 1128, 1130 (Fed. Cir. 1998).
V. ORIGINAL CLAIM NOT SUFFICIENTLY DESCRIBEDWhile there is a presumption that an adequate written description of the claimed invention is present in the specification as filed. In re Wertheim, 541 F.2d 257, 262, 191 USPQ 90, 96 (CCPA 1976), a question as to whether a specification provides an adequate written description may arise in the context of an original claim. An original claim may lack written description support when (1) the claim defines the invention in functional language specifying a desired result but the disclosure fails to sufficiently identify how the function is performed or the result is achieved or (2) a broad genus claim is presented but the disclosure only describes a narrow species with no evidence that the genus is contemplated. See Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1349-50 (Fed. Cir. 2010) (en banc). The written description requirement is not necessarily met when the claim language appears in ipsis verbis in the specification. “Even if a claim is supported by the specification, the language of the specification, to the extent possible, must describe the claimed invention so that one skilled in the art can recognize what is claimed. The appearance of mere indistinct words in a specification or a claim, even an original claim, does not necessarily satisfy that requirement.”Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956, 968, 63 USPQ2d 1609, 1616 (Fed. Cir. 2002).
See MPEP § 2163, subsection I.A and MPEP § 2163, subsection II.A.3(a) for further discussion of rebutting the presumption of adequate written description for originally presented claims.
VI. INDEFINITENESS REJECTION OF A MEANS- (OR STEP-) PLUS-FUNCTION LIMITATIONA claim limitation expressed in means- (or step-) plus-function language “shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.” 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. If the specification fails to disclose sufficient corresponding structure, materials, or acts that perform the entire claimed function, then the claim limitation is indefinite because the applicant has in effect failed to particularly point out and distinctly claim the invention as required by 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. In re Donaldson Co., 16 F.3d 1189, 1195, 29 USPQ2d 1845, 1850 (Fed. Cir. 1994) (en banc). Such a limitation also lacks an adequate written description as required by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, because an indefinite, unbounded functional limitation would cover all ways of performing a function and indicate that the inventor has not provided sufficient disclosure to show possession of the invention. See also MPEP § 2181.