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 . 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.
Election/Restrictions
Applicants elected a formulation of SEQ ID 1 to treat the patient population of claim 2 with traverse in the reply filed on 24 April, 2025. The traversal was found unpersuasive and the election/restriction requirement made final in the office action of 8 May, 2025.
Claims Status
Claims 1-9 and 11-21 are pending.
Claim 1 has been amended.
Claims 3-9, 19, and 20 have been withdrawn due to an election/restriction requirement.
Claim Objections
Applicant is advised that should claim 1 be found allowable, claim 21 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Rejections - 35 USC § 102
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.
Claim(s) 1, 2, 11-18, and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lintner (US 6,620,419) with evidentiary support from Andrus (Dermatol. Times, 14 April, 2023) and Toda et al (J. Biosci. Bioeng. (2006) 102(6) p524-528).
Lintner discusses cosmetic peptides for improving skin appearance (title). A formulation comprising Pal-KTTKS (identical to applicant’s elected species) and beeswax, along with a number of other ingredients is discussed (example 2, column 4, line 15-30). Note that beeswax is an occlusive that forms a barrier to protect against external irritants and maintain skin integrity (as evidenced by Andrus, 2nd page, 5th paragraph) (strengthening the skin barrier function, claim 2). The formulation was applied to 15 feminine adult volunteers (mammalian subject), at the corner of either the left or right eye (example 6, column 5, line 38-column 6, line 12). As evidenced by Toda et al, viscosity is modified by dissolved and suspended materials based on energy dissipation of the dissolved and suspended material (p524, 1st column, 2nd paragraph). Which means that anything dissolved or suspended in the formualtion (such as the beeswax of Lintner) will modify the viscosity of the formulation.
Lintner describes a peptide Pal-KTTKS, identical with applicant’s elected species, that was applied to the skin (i.e. epidermis) of human patients with a viscosity modifier, anticipating claims 1, 11-18 and 21.
The formulation comprised beeswax, which, as evidenced by Andrus, strengthens the skin barrier function, anticipating claim 2.
response to applicant’s arguments
Applicants argue that the limitation of a rheology modifier overcomes the rejection.
Applicant's arguments filed 24 Sept, 2025 have been fully considered but they are not persuasive.
As noted in the rejection, anything in the formulation will modify the viscosity. Thus, the formulation of Litner et al has a rheology modifier; the beeswax.
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.
first rejection
Claims 1, 2, 11-18, and 21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 8 and 16-18 of copending Application No. 17/911,840 (US 20230146941) with evidentiary support from Toda et al (J. Biosci. Bioeng. (2006) 102(6) p524-528).
Competing claim 1 describes a non-therapeutic cosmetic treatment to treat sagging skin, comprising administering a cosmetic formulation to the skin. Competing claim 8 specifies that the patient is a woman (a mammal). Competing claims 16-18 describes additional components of the formulation, such as certain peptide sequences, down to Pal-KTTKS, applicant’s elected species. As this is the same peptide as is used in the examined claims, it will necessarily have the same effects. As evidenced by Toda et al, viscosity is modified by dissolved and suspended materials based on energy dissipation of the dissolved and suspended material (p524, 1st column, 2nd paragraph). Which means that anything (such as the therapeutic of the competing claims) will modify the viscosity of the formulation.
This is a provisional nonstatutory double patenting rejection.
response to applicant’s arguments
Applicants argue that the competing claims do not have a rheology modifier, and have additional active ingredients.
Applicant's arguments filed 24 Sept, 2025 have been fully considered but they are not persuasive.
Applicants argue that the material of the competing claims lacks a rheology modifier. That is not correct; as noted in the rejection, additional ingredients will act as a rheology modifier.
Applicants argue that the competing claims have additional ingredients. Applicants have not demonstrated how this overcomes the rejection.
second rejection
Claims 1, 2, 11-18, and 21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 10, and 11 of U.S. Patent No. 9,126,060.
Competing claim 1 describes an antiaging therapy applied to the skin, which has a very high viscosity (indicationg a rheology modifier), while competing claim 10 requires an ingredient selected from a Markush group including Pal-KTTKS. Note that, as this is the same sequence used in the examined claims, it will necessarily have the same effects. Competing claim 11 describes where the material is placed, including decollete, which only applies to human females (mammals).
response to applicant’s arguments
Applicants have repeated the same arguments for all double patenting rejections, which were answered above.
third rejection
Claims 1, 2, 11-18, and 21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 6, 11, 15, and 16 of U.S. Patent No. 8,603,498 in view of Hines (Good Housekeeping, published 10 Jan, 2017).
Competing claim 6 specifies a formulation comprising an active ingredient (which will also act as a rheology modifier), while competing claims 15 and 16 include additional ingredients selected from a Markush group that includes Pal-KTTKS, applicant’s elected species. Competing claim 11 describes using these formulations to firm skin, comprising topically applying the material.
The difference between the competing claims and the examined claims is that the competing claims do not specify a mammalian subject.
Hines discusses tightening the skin “on your face” (title). Note that “your face” indicates the reader, a skill which is limited to humans.
Therefore, it would be obvious to use the formulation of the competing claims on the subjects of Hines, as they are attempting to perform the same process (tightening skin). As this is a subgenera of the patients of the competing claims, an artisan in this field would attempt this therapy with a reasonable expectation of success.
response to applicant’s arguments
Applicants have repeated the same arguments for all double patenting rejections, which were answered above.
fourth rejection
Claims 1, 2, 11-18, and 21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 8, and 11 of U.S. Patent No. 8,530,426.
Competing claim 1 describes a cosmetic formulation (the ingredients of which will modify the rheology of the formulation), while competing claim 8 describes a Markush group of additional ingredients, including Pal-KTTKS, applicant’s elected species. Competing claim 11 describes a method using the formulation, comprising applying the formulation to the skin of a person (interpreted as a human).
response to applicant’s arguments
Applicants have repeated the same arguments for all double patenting rejections, which were answered above.
Conclusion
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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 FRED REYNOLDS whose telephone number is (571)270-7214. The examiner can normally be reached M-Th 9-3:30.
Examiner interviews are available via telephone 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.
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/FRED H REYNOLDS/Primary Examiner, Art Unit 1658