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 .
DETAILED ACTION
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/30/2025 has been entered.
Claim Status
Claims 31-34, 37-45 and 48-59 are pending. Claims 35-36 and 46-47 have been canceled. Claims 31-34 and 42-45 have been amended. Claims 42-45 and 48-59 are allowable. Claims 31-34 and 37-41, previously withdrawn from consideration as a result of a restriction requirement, require all the limitations of an allowable claim. Pursuant to the procedures set forth in MPEP § 821.04(a), the restriction requirement between inventions I-II, as set forth in the Office action mailed on 1/16/2025, is hereby withdrawn and claims 31-34 and 37-41 are hereby rejoined and fully examined for patentability under 37 CFR 1.104. In view of the withdrawal of the restriction requirement, applicant(s) are advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application. Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
Terminal Disclaimer
The terminal disclaimer filed on 10/30/2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of US11174300, US11332505 and copending Application No. 17/491228 has been reviewed and is accepted. The terminal disclaimer has been recorded.
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.
This is a new rejection.
Claims 31-34, 37 and 40-41 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 claims are drawn to a method of improving appearance of skin of a subject, the method comprising: topically administering to the skin of the subject a polypeptide comprising: (i) an amino acid sequence having at least about 75% sequence identity to a truncate of SEQ ID NO: 31, wherein the truncate of SEQ ID NO: 31 has an N-terminal truncation of 50 amino acids to 650 amino acids, a C-terminal truncation of 50 amino acids to 300 amino acids, or both the N-terminal truncation and the C-terminal truncation, relative to SEQ ID NO: 31; or (ii) an amino acid sequence having at least about 80% sequence identity to a truncate of SEQ ID NO: 32, wherein the truncate of SEQ ID NO: 32 has an N-terminal truncation of 50 amino acids to 750 amino acids, a C-terminal truncation of 50 amino acids to 650 amino acids, or both the N-terminal truncation and the C-terminal truncation, relative to SEQ ID NO: 32.
When referring to the polypeptide, the specification does not provide any structural attribute.
Without a correlation between structure and function, the claims do little more than define the claimed invention by function. That is not sufficient to satisfy the written description requirement. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406 (“A definition by function alone “does not suffice” to sufficiently describe a coding sequence because it is only an indication of what the gene does, rather than what it is”).”
Here, the specification fails to describe what part of the polypeptide (i.e. the specific amino acids) correlates with the required activity (i.e. to improve appearance of skin).
The MPEP states that a broad genus can be described by a showing of representative number of examples. The claims in the instant application are broad.
Based on the teachings of the specification, the polypeptide can be any polypeptide comprising an amino acid sequence having at least about 75% sequence identity to a truncate of SEQ ID NO: 31 (or an amino acid sequence having at least about 80% sequence identity to a truncate of SEQ ID NO: 32).
For instance, SEQ ID NO: 31 is 957 amino acids long. A 75% identity means that 239 amino acids can be substituted. Thus, one would end up with an enormous number of possible polypeptides having at least 75% identity to SEQ ID NO: 31.
However, the specification fails to provide a representative number of examples for the claimed polypeptide.
The specification does not provide any teaching of what modifications can be made within the claimed sequence to allow for the claimed function.
The description requirement of the patent statute requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736 F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming a rejection for lack of written description because the specification does “little more than outline goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate”).
Therefore, since the specification fails to identify any relevant structural characteristics that can be attributed to the claimed function and activity, the claimed invention lacks written description.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
This is a new rejection.
Claims 31-34, 37-38 and 40-41 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-4, 9-10, 12, 19-22, 26-27, 29-30, 33, 35, 37, 39-40, 42, 44, 46, 48 and 58 of copending Application No. 18/420585 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they relate to the same topical composition.
With respect to claims 31-34, ‘585 teaches a method for promoting, improving, and/or maintaining youthful skin in an individual comprising applying to the individual a cosmetic formulation comprising: a polypeptide comprising an amino acid sequence having at least 80% sequence identity to SEQ ID NO: 32, or a polypeptide comprising an amino acid sequence having at least 80% sequence identity to a truncate of SEQ ID NO: 32, wherein the cosmetic formulation is selected from the group consisting of a cream, a gel, a gel cream, an oil, an ointment, a serum, a foam, a lotion, a paste, a balm, a solution, a suspension, and a powder (claim 39), wherein the truncate of SEQ ID NO: 32 comprises an N-terminal truncation, a C-terminal truncation, or both, relative to SEQ ID NO: 32 (claim 9), and wherein the N-terminal truncation is an N-terminal truncation of 50 amino acids to 750 amino acids relative to SEQ ID NO: 32; and/or wherein the C-terminal truncation is a C-terminal truncation of 50 amino acids to 600 amino acids relative to SEQ ID NO: 32 (claim 10).
Please note that SEQ ID NO: 32 of ‘585 corresponds to instantly claimed SEQ ID NO: 32.
With respect to claim 37, ‘585 teaches that the polypeptide is 50 amino acids to 250 amino acids in length (claim 19).
With respect to claims 38 and 40, ‘585 teaches that the polypeptide comprises an amino acid sequence having at least 80%, at least 90%, at least 95%, or at least 98% sequence identity to SEQ ID NO: 8 (claim 12).
With respect to claim 41, ‘585 teaches that promoting, improving, and/or maintaining youthful skin of the individual comprises improving firmness of the skin (claim 40).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
This is a new rejection.
Claims 31-34, 37-38 and 40 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9, 12-15, 18-19, 22, 25, 44, 67 and 69 of copending Application No. 18420597 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they relate to the same topical composition.
With respect to claims 31-34, ‘597 teaches a method of treating a wound and/or a proliferative disorder in skin (i.e. improving appearance of skin) of a subject, the method comprising: administering to the skin of the subject a therapeutically effective amount of a polypeptide comprising an amino acid sequence having at least 80% sequence identity to SEQ ID NO: 32, or a functional truncate of SEQ ID NO: 32 (claim 1), wherein the method comprises administering the polypeptide to the wound or to skin adjacent to the wound (claim 4), wherein the N-terminal truncation comprises a truncation of 50 amino acids to 700 amino acids relative to SEQ ID NO: 32 (claim 13), and wherein the C-terminal truncation comprises a truncation of 50 amino acids to 550 amino acids relative to SEQ ID NO: 32 (claim 14).
Please note that SEQ ID NO: 32 of ‘597 corresponds to instantly claimed SEQ ID NO: 32.
With respect to claim 37, ‘597 teaches that the polypeptide is 50 amino acids to 250 amino acids in length (claim 18).
With respect to claims 38 and 40, ‘597 teaches that the polypeptide comprises the amino acid sequence of SEQ ID NO: 8 (claim 15).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Allowable Subject Matter
Claim 39 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SERGIO COFFA whose telephone number is (571)270-3022. The examiner can normally be reached M-F: 6AM-4PM.
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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.
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/SERGIO COFFA Ph.D./
Primary Examiner
Art Unit 1658
/SERGIO COFFA/Primary Examiner, Art Unit 1658