Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The Applicants’ Amendment to the Claims filed on 12/26/2025 is entered.
Information Disclosure Statement
The IDS filed on 12/26/2025 has been considered by the examiner.
Claims 1-5 and 9-10 are cancelled.
Claims 26-27 are new.
Claims 6-8, and 11-27 are pending and under examination.
Priority
This US16/919,680 filed on 07/02/2020 claims US priority benefit of US Provisional 62/872,301 filed on 07/10/2019.
Response to Amendment
Any/all objections and rejections made in the previous office action and not repeated in this office action are withdrawn in view of the Applicant's Amendment to the Claims filed on 12/26/2025.
Claim Rejections - 35 USC § 112 – new grounds necessitated by amendment
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Newly added claims 26-27 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 26-27 recite a method of treating a fibrotic or fibrotic-related disease or disorder in a subject in need thereof by administering to the subject an effective amount of a composition comprising: a C-terminal endostatin-derived peptide that is 36 amino acids in length and has an amino acid sequence that is at least 94% identical (or 97% identical for claim 27) to instant SEQ ID NO: 2 or a nucleic acid encoding such.
Thus the claims require the critically essential element of a therapeutic peptide with required therapeutic functional properties. In the claims the peptide is defined by amino acid length (36 amino acids having sequence of SEQ ID NO: 2) and with the limitation that the amino acid sequence is at least 94%/97% to instant SEQ ID NO: 2.
Present claims recite 94% or 97% identical in a 36 amino acid peptide which allows for three or two amino acid changes to instant SEQ ID NO: 2. Note that even a single amino acid substitution in a therapeutic peptide can change the function of such peptide. Further, neither the instant Specification nor the state of the art shows how one of ordinary skill in the art would be able to envision whether a given amino acid substitution in the claimed peptides could tolerate such substitutions and still possess the required therapeutic functional properties. For example, the post-filing art of Slansky et al titled “Peptide mimotopes alter T cell function in cancer and autoimmunity” (Semin Immunol 2020 Feb: Vol 47, epub March 20, 2020; of record), disclose that even single amino acid substitutions in therapeutic peptides change binding affinities and therapeutic effects. (See abstract). In addition, Sengupta et al in “Site-specific amino acid substitution in dodecameric peptides determines the stability and unfolding of c-MYC quadruplex promoting apoptosis in cancer cells” (Nucleic Acids Res 2018 Nov 2 Vol 46 No. 19: pages 9932-9950; of record) discloses that even single amino acid substitutions in therapeutic peptides change binding affinities and therapeutic effects. (See abstract).
Further, the instant Specification shows therapeutic activity using the full-length peptides of SEQ ID NO: 2. (See Example 1, pages 60-63; Example 2, pages 63-65; Example 3, pages 65-66) However, the specification does not show a representative set of variants of such peptides encompassed by the claims having therapeutic activity.
The MPEP states that if a biomolecule is described only by a functional characteristic, without any disclosed correlation between function and structure of the sequence, it is “not sufficient characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence.” MPEP 2163. The MPEP does state that for generic claim the genus can be adequately described if the disclosure presents a sufficient number of representative species that encompass the genus. MPEP 2163. If the genus has a substantial variance, the disclosure must describe a sufficient variety of species to reflect the variation within that genus. See MPEP 2163. Although the MPEP does not define what constitute a sufficient number of representative, the Courts have indicated what do not constitute a representative number species to adequately describe a broad generic. In Gosteli, the Court determined that the disclosure of two chemical compounds within a subgenus did not describe that subgenus. In re Gosteli, 872 F.2d at 1012, 10 USPQ2d at 1618.
In this case, the application does not identify any specific peptide variants of instant SEQ ID NO: 2 having the required therapeutic properties.
The court and the Board have repeatedly held (Amgen Inc. v. Chugai Pharmaceutical Co. Ltd.,18 USPQ2d 1016 (CA FC, 1991); Fiers v. Revel, 25 USPQ2d 1601 (CA FC 1993); Fiddes v. Baird, 30 USPQ2d 1481 (BPAI 1993) and Regents of the Univ. Calif. v. Eh Lilly & Co., 43 USPQ2d 1398 (CA FC, 1997)) that an adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method for isolating it, irrespective of the complexity or simplicity of the method; what is required is a description of the nucleic acid itself.
Thus, one of skill at the time of the invention could not have concluded that the inventor(s) were in possession of the genus of therapeutic peptides encompassed by the present claims.
Response to Arguments
The applicants’ response filed on 12/26/2025 has been fully considered as it relates to this new grounds of rejection against newly added claims 26-27. The applicants argue the following:
Regarding new claims 26 and 27, Applicant submits that peptides of 36 amino acids in length, that are at least 94% identical to SEQ ID NO:2, and peptides of 36 amino acids in length, that are at least 97% identical to SEQ ID NO:2, are clearly described in the application was filed, and one of skill in the art would have no difficulty in recognizing that the inventors were in possession of the same. To satisfy the written description requirement under 35 U.S.C. § 112(a), a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. MPEP § 2163(I). This possession may be shown in any number of ways. For example, for newly added claim limitations, the MPEP requires that the specification provide support through express, implicit, or inherent disclosure. MPEP § 2163(I)(B). To determine whether the specification provides express, implicit, or inherent disclosure, the MPEP dictates that the factual inquiry to be used is whether the specification conveys with reasonable clarity to those skilled in the art that, as of the filing date sought, Applicants were in possession of the invention as now claimed. Id. Applicant respectfully submits that such reasonable clarity is present in the specification.
However, this argument is unpersuasive for reasons provided in the body of the rejection above. In this case, the application does not identify any specific peptide variants of instant SEQ ID NO: 2 having the required therapeutic properties. The instant specification shows therapeutic activity using the full-length peptides of SEQ ID NO: 2. (See Example 1, pages 60-63; Example 2, pages 63-65; Example 3, pages 65-66) However, the specification does not show a representative set of variants of such peptides encompassed by the claims having therapeutic activity. As evidenced by the state of the art, even a single change in an amino acid contained in a nine amino acid peptide can change the functional properties of the peptides. The claims require a functional, therapeutic peptide capable of treating a fibrotic or fibrotic-related disease or disorder in a subject. The court and the Board have repeatedly held (Amgen Inc. v. Chugai Pharmaceutical Co. Ltd.,18 USPQ2d 1016 (CA FC, 1991); Fiers v. Revel, 25 USPQ2d 1601 (CA FC 1993); Fiddes v. Baird, 30 USPQ2d 1481 (BPAI 1993) and Regents of the Univ. Calif. v. Eh Lilly & Co., 43 USPQ2d 1398 (CA FC, 1997)) that an adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method for isolating it, irrespective of the complexity or simplicity of the method; what is required is a description of the nucleic acid itself.
Allowable Subject Matter
Claims 6-8, and 11-25 are allowed.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CATHERINE S HIBBERT whose telephone number is (571)270-3053. The examiner can normally be reached M-F 8:00-5:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melissa Fisher can be reached at 571-270-7430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/CATHERINE S HIBBERT/Primary Examiner, Art Unit 1658