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 .
Power of Attorney
The Examiner was unable to call Applicant to discuss outstanding issues in this application because a power of attorney has not been filed. Applicant is encouraged to file a power of attorney to facilitate compact prosecution.
Claim Rejections - 35 USC § 101 - withdrawn
The rejection of claims 62 and 63 under 35 U.S.C. 101 is moot because the claims were canceled in the response filed February 17, 2026.
Claim Interpretation
BRI of the claim limitation (emphasis added) “a peptide or peptide derivative comprising an amino acid sequence of Asn-Ala-Xaa2-Met (SEQ ID NO: 1), wherein Xaa2 is His or Ala” includes peptides and peptide derivatives comprising full-length Asn-Ala-Xaa2-Met as well as fragments of Asn-Ala-Xaa2-Met (e.g. Asn-Ala, Ala-Xaa2, Xaa2-Met etc).
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 44-48, 53-57, and 65 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.
The MPEP states that "[w]hile there is no in haec verba requirement, newly added claim limitations must be supported in the specification through express, implicit, or inherent disclosure" (see, e.g., MPEP § 2163(I)(B)).
In the response filed February 17, 2026, claims 44 and 53 were amended to “a peptide or peptide derivative comprising an amino acid sequence of Asn-Ala-Xaa2-Met (SEQ ID NO: 1), wherein Xaa2 is His or Ala”, which includes peptides and peptide derivatives comprising full-length Asn-Ala-Xaa2-Met as well as fragments of Asn-Ala-Xaa2-Met (e.g. Asn-Ala, Ala-Xaa2, Xaa2-Met etc). The claims were originally directed to “a peptide or peptide derivative comprising the amino acid sequence of Asn-Ala-Xaa2-Met (SEQ ID NO: 1), wherein Xaa2 is His or Ala”, which was limited to peptides and peptide derivatives comprising full-length Asn-Ala-Xaa2-Met.
The standards for determining compliance with the written description requirement is discussed at MPEP § 2163. Notably, the introduction of claim changes which involve broadening the claims by introducing elements or limitations which are not supported by the as-filed disclosure is a violation of the written description requirement of 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph. Here, the issue is whether or not the original disclosure provided support specifically for peptides and peptide derivatives comprising fragments of Asn-Ala-Xaa2-Met (e.g. Asn-Ala, Ala-Xaa2, Xaa2-Met etc).
Neither the amended claim nor the amended claim language literally appears in the originally-filed disclosure. Zero examples of the instantly claimed invention literally appear in the originally-filed disclosure. Accordingly, the amended claim scope is not supported by express disclosure in the originally-filed disclosure.
In addition, disclosure of peptides and peptide derivatives comprising full-length Asn-Ala-Xaa2-Met does not provide implicit or inherent support for peptides and peptide derivatives comprising fragments of Asn-Ala-Xaa2-Met (e.g. Asn-Ala, Ala-Xaa2, Xaa2-Met etc). The specification does not describe a general correlation between structure and function for the claimed genus. As a result, it is impossible to predict, based on the specification, how deleting any position will affect use in treating skin and hair pigmentation.
Accordingly, amended claims 44-48, 53-57, and 65 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.
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.
Claims 44-45, 47-48, 53-54, 56-57, and 65 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dal Farra et al. (US 2010/0152119 A1).
Dal Farra et al. teach methods of inducing, restoring or stimulating natural pigmentation of the skin or hair, increasing melanization, treating a disorder of the pigmentation of the skin, particularly vitiligo, and/or preventing or treating whitening of hair comprising administering an effective amount of the peptide Gly-Gly-Leu-Thr-Leu-Leu-Ala-Ala (SEQ ID No. 2) or Leu-Thr-Leu-Leu-Ala-Ala (SEQ ID No. 3) (claims 2, 21-26; para. [0023]-[0024], [0071]-[0073]; Examples 1-2).
The peptide Gly-Gly-Leu-Thr-Leu-Leu-Ala-Ala (SEQ ID No. 2) is a peptide of instant claim 44 because it is eight amino acids in length and comprises Ala-Ala, which is a fragment of instant SEQ ID NO: 1 wherein Xaa2 is Ala.
The peptide Leu-Thr-Leu-Leu-Ala-Ala (SEQ ID No. 3) is a peptide of instant claim 44 because it is six amino acids in length and comprises Ala-Ala, which is a fragment of instant SEQ ID NO: 1 wherein Xaa2 is Ala.
Therefore, Dal Farra et al. satisfy all of the limitations of and anticipate instant claim 44.
Regarding claim 45, Dal Farra et al. teach that the peptides increases melanin pigmentation of skin or hair of the subject (Example 1; claim 26).
Regarding claims 47-48 and 56-57, Del Farra et al. teach Leu-Thr-Leu-Leu-Ala-Ala (SEQ ID No. 3), which is six amino acids in length.
Regarding claim 53-54 and 56-57, Dal Farra et al. teach that the peptides can be used to treat vitiligo (para. [0060], [0071]; claim 24).
Regarding claim 65, Dal Farra et al. teach that the peptides can be modified by acetylation at the N-terminus or amidation at the C-terminus (para. [0034]).
Allowable Subject Matter
Claims 49-52, 58-61, and 64 are 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 following claims drafted by the examiner and considered to distinguish patentably over the art of record in this application and to resolve the issues under 35 U.S.C. 112, are presented to applicant for consideration:
44. A cosmetic method of darkening of skin or hair color, the method comprising administering to a subject in need thereof a peptide or peptide derivative comprising is in length.
53. A method for treatment of a disease or disorder associated with hypopigmentation comprising administering to a subject in need thereof a peptide or peptide derivative comprising is in length.
The following is a statement of reasons for the indication of allowable subject matter:
US 2016/0132631 A1 discloses the tetrapeptide NAAM (SEQ ID NO: 1758). The reference is directed to epitope peptides from the Brucella species bacteria (para. [0009]). The reference does not teach or suggest NAAM for darkening of skin or treating hypopigmentation related diseases.
US 2011/0318380 A1 discloses a peptide that is no more than 8 residues in length and that comprises NAHM (SEQ ID NO: 95806). The reference is directed to MHC multimers and cancer vaccines (para. [0033]). The reference does not teach or suggest NAHM for darkening of skin or treating hypopigmentation related diseases.
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 CHRISTINA MARCHETTI BRADLEY whose telephone number is (571)272-9044. The examiner can normally be reached Monday-Friday, 7 am - 3 pm.
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, Lianko G Garyu can be reached at (571) 270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHRISTINA BRADLEY/Primary Examiner, Art Unit 1654