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 .
Amendment after Non-final office action filed on June 9, 2026 is acknowledged.
Claim 30 have been cancelled.
Claims 26, 29 and 31-47 are pending in this application.
Applicant elected Group 1 (claims 22-38) and elected Ac-RFAACAA as the species of the peptide sequence, thiol as the species of reactive group, histidine as the species of amino acid, emulsion as the species of type of preparation, and vitamin E as the species of antioxidant or stabilizer in the reply filed on November 15, 2024. Because Applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election had been treated as an election without traverse (see MPRP 818.01(a)). Restriction was deemed to be proper and was made FINAL in the previous office action. Claims 39-41 remain withdrawn from consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected invention, there being no allowable generic or linking claim. Claims 26, 29, 31-38 and 42-47 are examined on the merits in this office action.
This application contains claims 39-41, drawn to an invention nonelected without traverse in the paper of 11/15/2024. A complete reply to the final rejection must include cancellation of nonelected claims or other appropriate action (37 CFR 1.144). See MPEP § 821.01.
Withdrawn Rejections
Rejection of claims 26, 29, 36-38 and 42-44 under 35 U.S.C. 102(a)(1) as being anticipated by Groux et al (US Patent No. 8703431, cited in the previous office action), is hereby withdrawn in view of Applicant’s amendment to the claims.
Rejection of claims 26, 29-31, 36-38, 42-44 and 47 under 35 U.S.C. 102(a)(1) as being anticipated by Pastorin et al (US 2020/0390670, cited in the previous office action), as evidenced by Morikis et al (US 2018/0057538, cited in the previous office action), is hereby withdrawn in view of Applicant’s amendment to the claims.
Rejection of claims 26, 29-38, 42-44 and 47 under 35 U.S.C. 103 as being unpatentable over Pastorin et al (US 2020/0390670, cited in the previous office action), as evidenced by Morikis et al (US 2018/0057538, cited in the previous office action) in view of Sweeney et al (US 2017/0027852, cited in the previous office action), is hereby withdrawn in view of Applicant’s amendment to the claims.
Rejection of claims 26, 29-38 and 42-47 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is hereby withdrawn in view of Applicant’s amendment to the claims.
Rejection of claims 26, 29, 31-38 and 42-47 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, is hereby withdrawn in view of Applicant’s amendment to the claims.
Rejection of claims 26, 29-38, 42-45 and 47 under 35 U.S.C. 103 as being unpatentable over Pastorin et al (US 2020/0390670, cited in the previous office action), as evidenced by Morikis et al (US 2018/0057538, cited in the previous office action) and in further view of Wei et al (US 2002/0004485, cited in the previous office action), is hereby withdrawn in view of Applicant’s amendment to the claims.
Please note, the specification has not been checked to the extent necessary to determine the presence of all possible error. Applicant's cooperation is required in correcting any errors of which applicant may become aware in the specification. MPEP § 608.01.
Maintained Rejections
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.
Claims 26, 29, 31-38 and 42-47 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 16-21, 24-32 and 36-37 of copending Application No. 17/759635 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because if one of ordinary skill in the art practiced the claimed invention of instant claims, one would necessarily achieve the claimed invention of copending claims and vice versa.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Instant claims are drawn to:
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Copending claims are drawn to:
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The scope of instant claims are similar with the copending claims. The preparation recited in both applications involve the same peptide sequences HHHHHH, Ac-RFAACAA, Ac-RFAALAA, RFAALAA, RFAACAA, Ac-RAACAA, RAACAA, Ac-RFACAA, RFACAA, Ac-RFACA and RFACA. Therefore, if one of ordinary skill in the art practiced the claimed invention of instant claims, one would necessarily achieve the claimed invention of copending claims, and vice versa.
Response to Applicant’s Arguments
Applicant argues that “The reference claims of the ‘635 application are directed to a preparation comprising one or more peptides having 2 to 10 amino acids, at least one of which has one or more reactive side chains, and with further (i) comprises one or more antioxidants and/or stabilizers and/or (ii) has a pH of less than 7.” Applicant indicates that “Applicants are prepared to consider the filing of one or more terminal disclaimers to obviate the same.”
Applicant’s arguments have been fully considered but are not found persuasive. The claims recited the exact same peptide sequences as instant peptide sequences in a preparation. Therefore, the scope of the claims is similar. Therefore, if one of ordinary skill in the art practiced the claimed invention of instant claims, one would necessarily achieve the claimed invention of copending claims, and vice versa. Until a proper terminal disclaimer is filed, the rejection is maintained herein.
Claims 26, 29, 31-38 and 42-47 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 36-55 of copending Application No. 17/759636 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because if one of ordinary skill in the art practiced the claimed invention of instant claims, one would necessarily achieve the claimed invention of copending claims, and vice versa. Please note: copending claims of 17/769636 have been amended. Claims 36-55 are pending in the copending application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Instant claims are drawn to:
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Copending claims are drawn to:
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Response to Applicant’s Arguments
Applicant argues that “The reference claims of the ‘636 application are directed to a peptide per se, a compound, effective in the treatment of allergic contact dermatitis, comprising 2 to 10 amino acids with one or more reactive side chains, and to the preparations generically defined by such peptides.” Applicant indicates that “Applicants are prepared to consider the filing of one or more terminal disclaimers to obviate the same.”
Applicant’s arguments have been fully considered but are not found persuasive. The amended claims of copending application explicitly recites the same peptide sequences as instant claims. Therefore, the scope of the claims is similar. Therefore, if one of ordinary skill in the art practiced the claimed invention of instant claims, one would necessarily achieve the claimed invention of copending claims, and vice versa. Until a proper terminal disclaimer is filed, the rejection is maintained herein.
CONCLUSION
No claim is allowed.
THIS ACTION IS MADE FINAL. 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 JULIE HA whose telephone number is (571)272-5982. The examiner can normally be reached Monday-Thursday 5:00 am- 6:30 pm EST.
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 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.
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.
/JULIE HA/Primary Examiner, Art Unit 1654
8/17/2026
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