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 .
The Petition to Accept Color Drawings was submitted on 3 July7 2025. This petition has not been decided at this time, but will be considered in due course.
Specification
The substitute specification filed 10/23/2025 and 10/31/2025 have both been entered. The 10/31/2025 substitute specification supercedes the original specification and the 10/23/2025 specification. The 10/31/2025 substitute specification is the current specification.
The disclosure is objected to because of the following informalities:
Figures 1A-C and 25 contain sequences but no corresponding sequence identifiers. The brief description of these drawings in the 10/31/2025 substitute specification does not include the corresponding SEQ ID NOS. either. Sequence identifiers for nucleotide and/or amino acid sequences must appear either in the drawings or in the Brief Description of the Drawings.
Page 12, line 5, of the 10/31/2025 substitute specification contains a sequence with no corresponding SEQ ID NO.
Page 49, lines 8 and 27, of the 10/31/2025 substitute specification contain sequence with no corresponding SEQ ID NOS. See SEQ ID NOS: 17 and 7 elsewhere on this page. See also pages 51 and 61-68 which recite sequences with no corresponding sequence identifiers.
See 37 CFR 1.821(d).
Appropriate correction is required.
Drawings
The replacement drawings (pages 1-56) were received on 10/23/2025. These drawings are acceptable.
Election/Restrictions
Applicant’s election of Group I, claims 1-18, and the biomimetic intracellular sigma peptide (ISP) sequence of SEQ ID NO: 2 in the reply filed on 2/11/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
As SEQ ID NO: 2 is contained within SEQ ID NO: 3 at amino acids 13-24, SEQ ID NO: 3 will be included in the sequence election. See claims 11. Upon further consideration, SEQ ID NO: 7 will also be included in the sequence election. See claim 13.
Claims 12 and 19-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species (claim 12) or invention (claims 19-20), there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 2/11/2026.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-11 and 13-18 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 is directed to a system having two parts, a) a peptide amphiphile and b) a peptide that interacts non-covalently with a). However, claim 1 and the dependent claims, particularly claim 14, are unclear if the system is a composition of matter (single product) where a) and b) are interacting or if the system is a composition having two separate components on the lines of a kit where a) is in one container and b) is in a second container. The system of claims 17-18 is further unclear as to how the cells are associated with a) the peptide amphiphile and/or b) the peptide that interacts non-covalently with a) in claim 1. The metes and bounds of the claim cannot be determined.
Claim 2 is confusing in reciting that the system comprises a nanofiber. It appears that what was intended is that the nanofiber is formed from multiple peptide amphiphiles (see part a) of claim 1). See for example the first paragraph of page 9 in the 10/31/2025 substitute specification. However, the claim does not make this clear. The metes and bounds of the claim cannot be determined.
Claim 3 is confusing in reciting “wherein the peptide comprises…” Claim 3 depends upon claim 1 and claim 1 recites multiple peptides. It appears that the intended peptide is the peptide of claim 1, part b). However, the claim language is not clear.
Claim 10 is confusing in its dependence upon claim 9. Netrin-1 mimetic sequences do not appear to correspond to mimetic sequences as recited in claim 9.
Claim 13 is confusing in its dependence upon claim 9. SEQ ID NOS: 6, 11, and 12 do not appear to correspond to mimetic sequences as recited in claim 9.
Claims 15-16 are ambiguous with respect to the peptide in claim 1 that is intended. Claim 1 recites multiple peptides. In addition, claims 1 and 15 lack antecedent basis for biomimetic sequences or peptides. The claims are confusing.
Claim Rejections - 35 USC § 102
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.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-5, 9, 13-14, and 17-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pinto et al. (WO 2020/154631, published 30 July 2020) or Pinto et al. (U.S. Patent Application Publication 2022/0213141, published 7 July 2022) or under 102(a)(2) as being anticipated by Pinto et al. (U.S. Patent No. 12,552,833, published 17 February 2026 and filed 24 January 2020).
Application 17/425,757 is the 371 filing from WO 2020/154631. Application 17/425,757 issued as U.S. Patent No. 12,552,833 and has the PGPUB of U.S. Patent Application Publication 2022/0213141. They are equivalent documents. The WO 2020/154631 document will be referenced.
Pinto et al. discloses a peptide amphiphile comprising a hydrophobic tail, a structural peptide segment having a total propensity for forming β-sheet conformations of 4 or less, a charged peptide segment and a bioactive peptide. The bioactive peptide can comprise IKVAV. See at least claims 1 and 9 of Pinto et al. IKVAV is identical to instant SEQ ID NO: 7, a biomimetic sequence that is a laminin mimetic sequence. See instant claims 9 and 13 and as evidenced by Nomizu et al. (of record) as claim 13 does not reference laminin for instant SEQ ID NO: 7. Note that the peptide amphiphile of claim 1 of Pinto et al. is not required to have the bioactive peptide attached by a linker. See at least claim 10 of Pinto et al. In addition, the instant claims as written do not preclude the bioactive peptide attached by a linker. The disclosure of Pinto et al. meets the limitations of the system of instant claim 1. With respect to instant claim 3, IKVAV contains a lysine (K) and would be a positively charged sequence. IKVAV could inherently interact non-covalently with the peptide amphiphile (see instant claim 1) and electrostatically (see instant claims 4-5) with the peptide amphiphile of Pinto et al. as disclosed by the instant specification. The peptide amphiphile of Pinto et al. can be a nanofiber. See at least claim 13 of Pinto et al. and instant claim 2. The peptide amphiphile can be used to generate any neuronal cells. Pinto et al. administers the peptide amphiphile to the central nervous system to treat injuries such as the spinal cord injury where cells, particularly neurons, would be present. See at least claims 17-19 of Pinto et al. This would meet the limitations of instant claims 17-18. Absent evidence to the contrary, the IKVAV in the peptide amphiphile of Pinto et al. would be mobile. See instant claim 14.
Claim Rejections - 35 USC § 103
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.
Claims 1-4, 9-11, 14, and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over any of Pinto et al. (WO 2020/154631, published 30 July 2020) or Pinto et al. (U.S. Patent Application Publication 2022/0213141, published 7 July 2022) or Pinto et al. (U.S. Patent No. 12,552,833, published 17 February 2026 and filed 24 January 2020) in view of Lang et al. (U.S. Patent No. 10,206,967).
The Pinto et al. references are applied as above but do not teach a bioactive peptide comprising instant SEQ ID NOS: 2 and 3. These are intracellular sigma peptide (ISP) sequences as recited in claims 9-11. Again, the WO 2020/154631 document will be referenced.
Lang et al. discloses SEQ ID NO: 12 as a bioactive peptide that allows neurons to advance on chondroitin sulfate proteoglycan (CSPG) substrates. The peptides promote reinnervation of cardiac tissue. See at least Table 2 at columns 11-12; column 9, line 40, through column 10, line 3; and column 12, lines 19-28. SEQ ID NO: 12 corresponds to instant SEQ ID NO: 3 and comprises instant SEQ ID NO: 2.
Pinto et al. is directed to using any bioactive peptide. It would have been obvious to use the bioactive peptide of Lang et al. in the peptide amphiphile product and nanofiber product of Pinto et al. as a suitable bioactive peptide. Again, the product in claim 1 of Pinto et al. is not required to have the bioactive peptide attached by a linker and the instant claims as written do not preclude the bioactive peptide being attached by a linker. See at least claim 10 of Pinto et al. With respect to instant claim 3, instant SEQ ID NOS: 2 and 3 would be charged sequences based on their amino acid composition. They would inherently interact non-covalently with the peptide amphiphile (see instant claim 1) and electrostatically (see instant claims 4-5) with the peptide amphiphile of Pinto et al. as disclosed by the instant specification. Pinto et al. includes charged peptide segments that could be positively or negatively charged. Pinto et al. discloses that the peptide amphiphile can be used to generate any neuronal cells. The bioactive peptide of Lang et al. is useful for promoting reinnervation of cardiac tissue. It would have been obvious to administer the peptide amphiphile of Pinto et al. having the bioactive peptide of Lang et al. to regenerate cardiac neurons. This would meet the limitations of instant claims 17-18. Absent evidence to the contrary, the SEQ ID NO: 3 in the peptide amphiphile of Pinto et al. would be mobile. See instant claim 14.
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 1-5, 9, and 13-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 and 4-7 of U.S. Patent No. 12,552,833. Although the claims at issue are not identical, they are not patentably distinct from each other.
Issued claim 1 recited a peptide amphiphile comprising a hydrophobic tail, a structural peptide segment, a charged peptide segment and a bioactive peptide. The bioactive peptide of SEQ ID NO: 25 in issued claim 2 comprises IKVAV, which is identical to instant SEQ ID NO: 7. SEQ ID NO: 7 is a biomimetic sequence that is a laminin mimetic sequence. See instant claims 9 and 13 and as evidenced by Nomizu et al. (of record) as claim 13 does not reference laminin for instant SEQ ID NO: 7. Note that the peptide amphiphile of claims 1 of Pinto et al. is not required to have the bioactive peptide attached by a linker and the instant claims as written do not preclude the bioactive peptide being attached by a linker. See claim 3 of Pinto et al. Issued claims 1-2 meet the limitations of the system of instant claim 1. With respect to instant claim 3, IKVAV contains a lysine (K) and would be a positively charged sequence. IKVAV could inherently interact non-covalently with the peptide amphiphile (see instant claim 1) and electrostatically (see instant claims 4-5) with the peptide amphiphile of Pinto et al. as disclosed by the instant specification. The peptide amphiphile of Pinto et al. can be a nanofiber. See issued claim 5 and instant claim 2. Absent evidence to the contrary, the IKVAV in the peptide amphiphile of Pinto et al. would be mobile. See instant claim 14.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARIANNE P ALLEN whose telephone number is (571)272-0712. The examiner can normally be reached 7:00-3:30 EST Monday-Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Hama can be reached at 571-272-2911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Marianne P Allen/Primary Examiner, Art Unit 1647
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