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
Election/Restrictions
Applicant’s election without traverse of CPP12 (SEQ ID NO: 58) in the reply filed on 1/20/2026 is acknowledged.
Applicants elected species was deemed to be free of the prior art. In accordance with Markush Practice, the search was extended to the Markush group/independent claim, and a reference was discovered that rendered it obvious. As a result, claims 1-4, 11 and 15 have been examined and claims 5-10, 12-14 and 16-19 are withdrawn from consideration. While applicant’s elected species may read on one or more withdrawn claims, they have not been fully examined for patentability, and thus a determination of allowability cannot be made with respect to these claims at this time. This is proper, as MPEP 803.02 states that, in these circumstances, the prior art search, however, will not be extended unnecessarily to cover all nonelected species (MPEP 803.02).
Status of the Claims
Claims 1-19 are pending in this application.
Claims 5-10, 12-14 and 16-19 are withdrawn from consideration as being drawn to a non-elected species.
Claims 1-4, 11 and 15 are presently under consideration as being drawn to the elected species.
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.
Claims 1-4, 11 and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Quian et al. (ACS Chem Biol. 2013 February 15; 8(2): 423-431).
With respect to claim 1, Quian et al. teach many peptides which correspond to the instantly claimed cyclic peptides. For instance, SEQ ID NO: 13 (i.e. the peptide cyclo(AFfRRRRQ) corresponds to the instantly claimed cyclic peptide of formula I-D wherein AA1 is Ala, AA2 is Phe, AA3 is L-2-naphthylalanine, AA4 is Arg, AA5 is Arg, AA6 is Arg, AA7 is Arg, AA8 is Gln.
Quian et al. also teach that “[o]ur cyclic CPPs are 2–5-fold more efficacious than R9 in transporting cargos including phosphopeptides into the mammalian cytoplasm and nucleus, apparently due to a more efficient endosomal escape process (page 7, 2nd para).
Quian et al. further teach that “[a]ll cyclic peptides contained a Lys(FITC)-NH2 attached to the side chain of the invariant Gln residue” (Table 1, page 22).
With respect to claim 2, AA3 in the peptide of Quian et al. corresponds to L-2-naphthylalanine.
With respect to claim 3, AA2 in the peptide of Quian et al. corresponds to Phe.
With respect to claim 4, as discussed above, AA2 and AA3 correspond to Phe and L-2-naphthylalanine, respectively.
With respect to claim 11, the Arg at position 4 is adjacent to L-2-naphthylalanine at position 3.
With respect to claim 15, the amino acids of the cyclic peptides of Quian et al. are in the natural stereoconfiguration.
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 1-4 and 11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 10626147. Although the claims at issue are not identical, they are not patentably distinct from each other because they relate to the same cyclic peptide.
With respect to claim 1, ‘147 teaches a cyclic peptide comprising formula Ia or formula IIa (claims 1 and 7), wherein m is 0; n and p are each 1; AA8 is L-arginine; and AA9 is L-glutamine (claims 3 and 9), wherein the cyclic peptide further comprises a cargo moiety, wherein the cargo moiety comprises a detectable moiety, a therapeutic moiety, a targeting moiety, or a combination thereof (claim 6).
With respect to claim 2, in the peptide of ‘147 (i.e. cyclo(ffRrRrRQ) AA2 corresponds to L-2-naphthylalanine.
With respect to claim 3, AA1 in the peptide of ‘147 corresponds to Phe.
With respect to claim 4, as discussed above, AA1 and AA2 correspond to Phe and L-2-naphthylalanine, respectively.
With respect to claim 11, the Arg at position 3 is adjacent to L-2-naphthylalanine at position 2.
Claims 1-4, 11 and 15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-40 of U.S. Patent No. 10815276. Although the claims at issue are not identical, they are not patentably distinct from each other because they relate to the same cyclic peptide.
With respect to claim 1, ‘276 teaches a cyclic peptide comprising formula Ia or IIa (claims 1 and 16) wherein AA1 is phenylalanine; AA2 is naphthylalanine; AA3 is arginine; AA4 is arginine; AA5 is arginine; AA6 is arginine (claims 12 and 28); and wherein m is 0; n and p are each 1; AA8 is arginine; and AA9 is glutamine (claims 14 and 30); and wherein the cargo moiety comprises a detectable moiety, a therapeutic moiety, a targeting moiety or a combination thereof (claims 16).
With respect to claim 2, in the peptide of ‘276 (i.e. cyclo(FfRRRRRQ) AA2 corresponds to L-2-naphthylalanine.
With respect to claim 3, AA1 in the peptide of ‘276 corresponds to Phe.
With respect to claim 4, as discussed above, AA1 and AA2 correspond to Phe and L-2-naphthylalanine, respectively.
With respect to claim 11, the Arg at position 3 is adjacent to L-2-naphthylalanine at position 2.
With respect to claim 15, the amino acids of the cyclic peptides of ‘276 are in the natural stereoconfiguration.
Claims 1-4, 11 and 15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-35 of U.S. Patent No. 11168310. Although the claims at issue are not identical, they are not patentably distinct from each other because they relate to the same cyclic peptide.
With respect to claim 1, ‘310 teaches a compound of formula V-A1, V-A2, or V-A3 (claims 1-2), which corresponds to the instantly claimed cyclic peptide of structure I-D (i.e. cyclo(FFfRRRRQ)), wherein AA1 is phenylalanine; AA2 is phenylalanine; AA3 is naphthylalanine; AA4 is arginine; AA5 is arginine; AA6 is arginine; AA7 is arginine; and AA8 is glutamine; wherein the cargo moiety (i.e. TP) is coupled to the side chain of glutamine (see claim 2).
With respect to claim 2, in the peptide of ‘310, AA3 corresponds to L-2-naphthylalanine.
With respect to claim 3, AA1 and AA2 in the peptide of ‘310 correspond to Phe.
With respect to claim 4, as discussed above, AA1, AA2 and AA3 correspond to Phe, Phe and L-2-naphthylalanine, respectively.
With respect to claim 11, the Arg at position 4 is adjacent to L-2-naphthylalanine at position 3.
With respect to claim 15, the amino acids of the cyclic peptides of ‘310 are in the natural stereoconfiguration.
Claims 1-4, 11 and 15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 11987821. Although the claims at issue are not identical, they are not patentably distinct from each other because they relate to the same cyclic peptide.
With respect to claim 1, ‘821 teaches a compound of formula V-A1, V-A2, or V-A3 (claims 1 and 8), which corresponds to the instantly claimed cyclic peptide of structure I-D (i.e. cyclo(FFfRRRRQ)), wherein AA1 is phenylalanine; AA2 is phenylalanine; AA3 is naphthylalanine; AA4 is arginine; AA5 is arginine; AA6 is arginine; AA7 is arginine; and AA8 is glutamine; wherein the cargo moiety (i.e. TP) is coupled to the side chain of glutamine (see claim 8).
With respect to claim 2, in the peptide of ‘821, AA3 corresponds to L-2-naphthylalanine.
With respect to claim 3, AA1 and AA2 in the peptide of ‘821 correspond to Phe.
With respect to claim 4, as discussed above, AA1, AA2 and AA3 correspond to Phe, Phe and L-2-naphthylalanine, respectively.
With respect to claim 11, the Arg at position 4 is adjacent to L-2-naphthylalanine at position 3.
With respect to claim 15, the amino acids of the cyclic peptides of ‘821 are in the natural stereoconfiguration.
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