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 Status
The amendments and remarks filed 06/08/2026 are acknowledged.
Claims 1 and 3-13 are pending.
Claims 1, 3, 5-7, and 9 are amended.
Claim 2 is cancelled.
Claims 11 and 12 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/04/2025.
Therefore, claims 1, 3-10 and 13 are under examination.
Withdrawn
The objections to the specification are withdrawn. Applicant has amended the specification to overcome the objection.
The objections to claims 1, 2, 5, 6, and 9 are withdrawn. Applicant has amended claims 1, 5, 6, and 9, and cancelled claim 2 to overcome the objections.
The rejections of claims 1-10 under 35 U.S.C. 112(a) written description are withdrawn. Applicant has amended claims 1 and 5 to overcome the rejections.
The rejections of claims 1-10 under 35 U.S.C. 112(a) enablement are withdrawn. Applicant has amended claims 1 and 5 to overcome the rejections.
The rejections of claims 1-10 under 35 U.S.C. 103 are withdrawn. Applicant has amended claims 1 and 5 to no longer require that the peptide is 14 amino acids having the sequence of SEQ ID NO: 1, but rather, the amended claims now only require that the peptide have (i.e. comprise) the sequence of SEQ ID NO: 1, which necessitates the new rejections under 35 U.S.C. 102. See below.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 06/15/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 5-10, and 13 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Liotta (WO2013065078; 06/30/2023 IDS).
Regarding claims 1, 5, 8, and 9, Liotta teaches that the topical administration to the skin of preparations containing Nerve Growth Factor (NGF) is effective in achieving an intensification of skin color, i.e. an increase in pigmentation, and improvement (treatment) of dermatological conditions involving skin achormias or hypochromias, such as in vitiligo [page 9, lines 14-20]. Liotta further teaches that a re-pigmentation of de-pigmentated areas was observed in patients suffering from vitiligo following treatment with a preparation of topical base cream containing NGF [page 9, lines 21-25]. Liotta also teaches that the solution, suspension or emulsion containing NGF according to the invention may contain various additional biologically active components, and/or NGF can be conjugated with carrier molecules or with molecules known to facilitate the permeation through the epidermis, or with cosmetically acceptable vehicles [page 13, lines 3-14]. Liotta additionally teaches that the NGF can be NGF of human origin (i.e. hNGF) [page 12, lines 8-9].
As evidenced by UniProt, 2019 (instant PTO-892), the sequence of human NGF comprises SEQ ID NO: 1 of the instant claim (i.e. residues 122-135 of hNGF) [see page 9, sequence listing and page 10, sequence alignment]. Thus, the NGF peptide of Liotta necessarily comprises SEQ ID NO: 1 as claimed, and therefore, the teachings of Liotta anticipate the instant claims.
Regarding claim 6, Liotta teaches that the preparation containing NGF contains 10 to 1000 ug/mL of NGF [page 18, lines 1-4]. MPEP 2144.05 (I) states “in the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facia case of obviousness exists.”
Regarding claims 7 and 13, Liotta teaches that that the preparation containing NGF is for topical application [page 11, lines 6-11] and can be in the form of a lotion, spray, cream, ointment, or gel [page 13, lines 23-25].
Regarding claim 10, Liotta teaches that in that the method for therapy of dermatological dyschromic disorders by applying a preparation containing NGF on the skin are to be treated is combined with a topical steroid preparation [page 18, lines 21-25 and page 24; claims 10 and 13].
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 3-10, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Liotta (WO2013065078; 06/30/2023 IDS), as applied to claims 1, 5-10, and 13 above, and further in view LifeTein, 2008 (03/11/2026 PTO-892).
The teachings of Liotta are above.
However, Liotta does not teach chemically modifying or protecting the N and/or C terminal of the peptide with an acyl compound to create a peptide derivative.
Regarding claims 3 and 4, LifeTein teaches that N-terminal acetylation can increase the stability of the peptide, increasing the peptides ability to resist enzymatic degradation, and the N-terminal acetylation generates a closer mimic of the native protein, and thus, increases the biological activity of the peptide and increases its ability to enter cells [see pages 2-3].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the NGF peptide, as taught by Liotta, to comprise an N-terminal acetylation, as taught by LifeTein. One would have been motivated to make this modification because LifeTein teaches that N-terminal acetylation can increase the stability of the peptide, increasing the peptides ability to resist enzymatic degradation, and generates a closer mimic of the native protein, thus increasing the biological activity of the peptide and its ability to enter cells.
Response to Arguments
The rejections of claims 1-10 under 35 U.S.C. 103 have been withdrawn as Applicant has amended claims 1 and 5 to no longer require that the peptide is 14 amino acids having the sequence of SEQ ID NO: 1, but rather, the amended claims now only require that the peptide have (i.e. comprise) the sequence of SEQ ID NO: 1, which necessitates the new rejections under 35 U.S.C. 102. However, the remarks will be addressed to the extent they apply to the new rejections. On page 7 of the remarks, Applicant argues unexcepted results of NGF1-14 compared to full-length NGF, pointing to Examples 2a and 2b of the instant specification for support. This is not persuasive because the results of Examples 2a and 2b are not commensurate in scope. The claims are directed to a peptide comprising SEQ ID NO:1 (i.e. NGF1-14), and are not limited to consisting of NGF1-14. Therefore, the results of Examples 2a and 2b of the instant application that Applicant relies upon to demonstrate unexpected results are not commensurate in scope with the instant claims. See MPEP 716.02(d).
Conclusion
No claims are allowed.
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 Brittney E Donoghue whose telephone number is (571)272-9883. The examiner can normally be reached Mon - Fri 7:30 - 3:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Stucker can be reached at (571) 272-0911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/B.E.D./Examiner, Art Unit 1675
/JEFFREY STUCKER/Supervisory Patent Examiner, Art Unit 1675
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