DETAILED ACTION
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 .
Claims 1-63, 65-67, 70-74, and 86 have been cancelled.
Applicant's arguments filed 10/3/2025 have been fully considered but they are not persuasive.
The rejection of claims 64, 68-69, 73, 84-85, and 87 under 35 U.S.C. 103 as being unpatentable over Eriksson et al. (U.S. Patent Application Publication 2014/0255397) in view of Fromond et al. (U.S. Patent Application Publication 2015/0232546) is withdrawn in view of the claim amendments to claim 64. None of the anti PDGF-C antibodies of Fromond et al. in Table 6 bind to SEQ ID NO: 86 (peptide number 48). This epitope corresponds to amino acids 3-17 of instant SEQ ID NO: 3. Anti-PDGF-C antibody 19F12 binds to SEQ ID NO: 87 (corresponding to amino acids 8-19 of instant SEQ ID NO: 3 plus two additional amino acids at the C-terminus) and anti-PDGF-C antibody sc-80290 binds to SEQ ID NO: 88 (corresponding to amino acids 13-19 of instant SEQ ID NO: 3 plus eight additional amino acids at the C-terminus). SEQ ID NOS: 87-88 do not comprise instant SEQ ID NO: 3. SEQ ID NOS: 87 and 88 are not wholly contained within instant SEQ ID NO: 3 and no more specific epitope for binding is defined by Fromond et al. The epitope sequence overlap is insufficient to meet the epitope limitations of claim 64 as amended.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 64-75, and antibodies 6B3, ch6B3, and hu6B3 as the antibody species, in the reply filed on 10/23/2023 is again acknowledged.
Claims 76-83 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10/23/2023.
Specification
The amendments to the specification submitted 10/3/2025 reference changes “relative to the specification as originally filed.” This is incorrect. All changes must be made with respect to the current specification; namely, the substitute specification submitted 5/24/2022 and entered, including all subsequent amendments made to this substitute specification (see amendments on 7/1/2024 and 10/29/2024). It is noted that while applicant references the specification as originally filed on 5/9/2022; the page and line references in the 10/3/2025 amendment correspond to the 5/24/2022 substitute specification.
These amendments have been entered; however, in the future applicant is advised to exercise care when amending the specification and to pay attention with respect to the version of the specification that is being amended.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
Claims 64, 68-69, 84-85, and 87 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.
Claim 64 as been amended to recite “an antibody or antigen-binding fragment thereof that: i. specifically interacts and shows measurable affinity to an epitope comprising SEQ ID NO: 3 or an epitope comprised within SEQ ID NO: 3; and ii. blocks PDGF-CC induced PDGFR-α activation.” The amendment to claim 64 removes the recitation “a polypeptide comprising the active portion of PDGF-C (SEQ ID NO: 2).”
Basis was stated to be in original claim 3 and claim 73 as well as page 50, lines 3-6, and page 53, lines 22-27. This is not agreed with.
Original claim 3 depended upon claim 2 and recites “polypeptide comprises SEQ ID NO: 3 or is substantially homologous thereto.” It does not recite epitopes or epitopes within SEQ ID NO: 3. It does not recite the limitation of claim 64, part ii, as amended.
Claim 73 recites that the polypeptide comprises SEQ ID NO: 3. It does not recite epitopes or epitopes within SEQ ID NO: 3. It does not recite the limitation of claim 64, part ii, as amended.
Page 50, lines 3-6, of the 5/24/2022 substitute specification refer to the epitope of antibody 6B3. Page 50, lines 1-2, disclose the antibody 6B3 epitope of SEQ ID NO: 112. This section of the specification does not disclose generic antibodies having any epitope within SEQ ID NO: 3 or the limitation of claim 64, part ii, as amended.
Page 53, lines 20-27, of the 5/24/2022 substitute specification reference antibodies 6B3, 11F5, 19C7, and 12F5 as blocking PDGF-CC-induced PDGFR-α activation. This section of the specification does not disclose generic antibodies having any epitope within SEQ ID NO: 3 and having the limitation of claim 64, part ii, as amended. In addition, only antibody 6B3 appears to meet the limitations of claim 64, part i.
There is no basis for the genus of antibodies encompassed by claim 64 as amended. The claims constitute new matter.
Claim 75 has not been included in this ground of rejection as the sequences recited in this claim correspond to antibodies 6B3 (corresponding to part b i), ch6B3 (corresponding to part b ii); and hu6B3 (corresponding to part b iii). See sequences on pages 4-5 of the specification. Note that SEQ ID NO: 16 is identical to SEQ ID NOS: 28 and 31; SEQ ID NO: 17 is identical to SEQ ID NOS: 29 and 32; and SEQ ID NO: 18 is identical to SEQ ID NOS: 30 and 33.
Claim 75 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. The prior art of record does not disclose anti-PDGF-C antibodies with the recited sequences.
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 MARIANNE P ALLEN whose telephone number is (571)272-0712. The examiner can normally be reached 7:00-3:30 EST Monday-Friday.
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, Joanne Hama can be reached at 571-272-2911. 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.
/Marianne P Allen/Primary Examiner, Art Unit 1647
mpa