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 .
Election/Restrictions and Claim Status
Applicants’ amendments and arguments filed 1/2/26 are acknowledged. Any objection or rejection from the 10/2/25 office action that is not addressed below is withdrawn based on the amendments.
Previously, the dimer form of SEQ ID NO:11 was elected.
The elected species does not include the specific features of claims 8 and 20 as set forth in the previous office action. Further, based on the claim amendment, claim 16 no longer reads on a dimer since it specifically recites a monomer.
Claims 8, 16 and 20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 9/2/25.
Claims 2-4 and 11-14 have been canceled.
Claims 1, 5-7, 9-10, 15 and 17-19 are being examined.
Priority
The priority information is found in the filing receipt of 4/26/23.
Claim Rejections - 35 USC § 103
Claims were previously rejected under 103 based on the reference cited below. Since the claims have been amended, the rejection is updated to correspond to the instant claims.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 5-7, 9-10, 15 and 17-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yu et al. (US 2016/0229894; ‘Yu’; first cited 10/2/25).
Yu teach alpha-helical, cell penetrating peptides (title and abstract). Yu teach a monomer peptide called RC of sequence comprising LCRLLRRLCR (section 0117 and SEQ ID NO:8 of Table 1) and the corresponding dimer having disulfide bonds called dimeric RC which was formed by air oxidation (section 0117). Yu expressly teach antiparallel dimers (section 0071). Yu teach that the dimeric peptide in a composition with siRNA specifically for delivery to cells (sections 0125-0126). Yu expressly teach a complex structure (section 0113). Yu also teach the dimer LK-3 (figure 24).
Yu does not teach a decapeptide of SEQ ID NO:11.
Yu expressly teach that the peptide can comprise 7-23 amino acids (claim 7). Figure 24 of Yu shows cell-penetrating abilities of various lengths of peptides. Yu states that the cell penetrating ability depends on the length (section 0074).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the teachings of Yu because Yu teach a monomer peptide called RC of sequence comprising LCRLLRRLCR (section 0117 and SEQ ID NO:8 of Table 1) and the corresponding dimer having disulfide bonds called dimeric RC which was formed by air oxidation (section 0117). Since Yu expressly teach antiparallel dimers (section 0071) one would have been motivated to make such peptides. Since Yu states that the cell penetrating ability depends on the length (section 0074) and recites that the peptide can comprise 7-23 amino acids one would have been motivated to make peptides of such length. One would have had a reasonable expectation of success since methods of making peptides was known (example 1).
In relation to formula 1 of claims 1, 9 and 15, Yu teach a peptide called RC of sequence comprising LCRLLRRLCR (section 0117 and SEQ ID NO:8 of Table 1) and the corresponding dimer having disulfide bonds called dimeric RC which was formed by air oxidation (section 0117). LCRLLRRLCR corresponds to instant SEQ ID NO:11 and is such that X1, X4, X5 and X8 are L; X3, X6, X7 and X10 are R; X2 and X9 are C specifically disulfide linked C. Since Yu states that the cell penetrating ability depends on the length (section 0074) and recites that the peptide can comprise 7-23 amino acids one would have been motivated to make peptides of such length.
In relation to the dimeric form and bonding of claims 1, 5-7 and 10, Yu teach a dimer of RC having disulfide bonds called dimeric RC which was formed by air oxidation (section 0117). Due to the process (air oxidation) the dimers formed would be in both anti-parallel and parallel directions. Further, Yu expressly teach antiparallel dimers (section 0071)
In relation to claims 17-19, Yu teach that the dimeric peptide in a composition with siRNA specifically for delivery to cells (sections 0125-0126). Yu expressly teach a complex structure (section 0113).
Response to Arguments – 103
Applicant's arguments filed 1/2/26 have been fully considered but they are not persuasive.
Although applicants argue about formation rates, cytotoxicity, cell-penetrating ability and self-association, it is noted that the features upon which applicant relies (i.e., formation rates, cytotoxicity, cell-penetrating ability and self-association) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Although applicants argue that there is no motivation or suggestion to modify Yu, Yu expressly teach antiparallel dimers (section 0071). Yu expressly teach that the peptide can comprise 7-23 amino acids (claim 7). Figure 24 of Yu shows cell-penetrating abilities of various lengths of peptides. Yu states that the cell penetrating ability depends on the length (section 0074).
Double Patenting
Claims were previously rejected based on the application and/or application and reference cited below. Since the claims have been amended the rejection is updated to correspond to the instant claims.
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, 5-7 and 9-10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of copending Application No. 18/701,162 (reference application; ‘162’).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
162 recites a peptide that can be a dimer that comprises formula 1 (claim 1) where formula 1 is SEQ ID NO:1 (claim 14) where SEQ ID NO:1 is ChaCRLLRRLCR (from table 1 on page 20). 162 recites a disulfide linkage between cysteine residues (claim 13). 162 recites a dimer in antiparallel direction (claim 12).
In relation to formula 1 of claims 1 and 9, 162 recites a peptide that can be a dimer that comprises formula 1 (claim 1) where formula 1 is SEQ ID NO:1 (claim 14) where SEQ ID NO:1 is ChaCRLLRRLCR (from table 1 on page 20). SEQ ID NO:1 and is such that X1 is Cha; X4, X5 and X8 are L; X3, X6, X7 and X10 are R; X2 and X9 are C specifically disulfide linked C.
In relation to the dimeric form and bonding of claims 1, 5-7 and 10, 162 recites a disulfide linkage between cysteine residues (claim 13). 162 recites a dimer in antiparallel direction (claim 12).
Claims 1, 5-7, 9-10, 15 and 17-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of copending Application No. 18/701,162 (reference application; ‘162’) in view of Yu et al. (US 2016/0229894; ‘Yu’).
This is a provisional nonstatutory double patenting rejection.
162 recites a peptide that can be a dimer that comprises formula 1 (claim 1) where formula 1 is SEQ ID NO:1 (claim 14) where SEQ ID NO:1 is ChaCRLLRRLCR (from table 1 on page 20). 162 recites a disulfide linkage between cysteine residues (claim 13). 162 recites a dimer in antiparallel direction (claim 12). 162 recites pharmaceutical compositions (claim 1) and suggest for treatments (claim 3). 162 recites that X1 can be Leu (claim 6).
162 does not recite substances as in claims 17-19.
Yu teach alpha-helical, cell penetrating peptides (title and abstract). Yu teach a monomer peptide called RC of sequence comprising LCRLLRRLCR (section 0117 and SEQ ID NO:8 of Table 1) and the corresponding dimer having disulfide bonds called dimeric RC which was formed by air oxidation (section 0117). Yu expressly teach antiparallel dimers (section 0071). Yu teach that the dimeric peptide in a composition with siRNA specifically for delivery to cells (sections 0125-0126). Yu expressly teach a complex structure (section 0113).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the teachings of 162 because 162 recites pharmaceutical compositions (claim 1) and suggest for treatments (claim 3). Since Yu teach similar peptides and suggest with substances such as siRNA (sections 0125-0126) one would have been motivated to combine with siRNA. Since 162 recites that X1 can be Leu (claim 6) and Yu teach alpha-helical, cell penetrating peptides (title and abstract) specifically a monomer peptide called RC of sequence comprising LCRLLRRLCR (section 0117 and SEQ ID NO:8 of Table 1) one would have been motivated to make such peptide. Since Yu states that the cell penetrating ability depends on the length (section 0074) and recites that the peptide can comprise 7-23 amino acids one would have been motivated to make peptides of such length. One would have had a reasonable expectation of success since methods of making peptides was known (example 1 of Yu).
In relation to formula 1 of claims 1, 9 and 15, 162 recites a peptide that can be a dimer that comprises formula 1 (claim 1) where formula 1 is SEQ ID NO:1 (claim 14) where SEQ ID NO:1 is ChaCRLLRRLCR (from table 1 on page 20). SEQ ID NO:1 and is such that X1 is Cha; X4, X5 and X8 are L; X3, X6, X7 and X10 are R; X2 and X9 are C specifically disulfide linked C. Further, Yu teach a monomer peptide called RC of sequence comprising LCRLLRRLCR (section 0117 and SEQ ID NO:8 of Table 1) and the corresponding dimer having disulfide bonds called dimeric RC which was formed by air oxidation (section 0117). LCRLLRRLCR corresponds to instant SEQ ID NO:11 and is such that X1, X4, X5 and X8 are L; X3, X6, X7 and X10 are R; X2 and X9 are C specifically disulfide linked C. Since Yu states that the cell penetrating ability depends on the length (section 0074) and recites that the peptide can comprise 7-23 amino acids one would have been motivated to make peptides of such length.
In relation to the dimeric form and bonding of claims 1, 5-7 and 10, 162 recites a disulfide linkage between cysteine residues (claim 13). 162 recites a dimer in antiparallel direction (claim 12).
In relation to claims 17-19, Yu teach that the dimeric peptide in a composition with siRNA specifically for delivery to cells (sections 0125-0126). Yu expressly teach a complex structure (section 0113).
Response to Arguments – double patenting
Applicant's arguments filed 1/2/26 have been fully considered but they are not persuasive.
Although applicants argue that the present application has the earlier patent term filing date and request that the rejection be held in abeyance, nothing has been done to overcome the rejections so the rejections remain of record. The MPEP section that applicants refer to is for situations in which the double patenting rejection is the only remaining rejection. In the instant case, the double patenting rejection is not the only remaining rejection.
Conclusion
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 RONALD T NIEBAUER whose telephone number is (571)270-3059. The examiner can normally be reached M - F 6:30 - 2:30 EST.
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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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RONALD T. NIEBAUER
Primary Examiner
Art Unit 1658
/RONALD T NIEBAUER/Examiner, Art Unit 1658