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 submitted on 3 July7 2025 was granted 24 September 2026.
Applicant's arguments filed 6/11/2026 have been fully considered but they are not persuasive.
Claim 3 has been cancelled.
The rejection of claims 1-5, 9, 13-14, and 17-18 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 (U.S. Patent No. 12,552,833, published 17 February 2026 and filed 24 January 2020) is withdrawn in view of applicant’s arguments.
The rejection of claims 1-4, 9-11, 14, and 17-18 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 (U.S. Patent No. 10,206,967) is withdrawn in view of applicant’s arguments.
The rejection of claims 1-5, 9, and 13-14 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ground of nonstatutory double patenting as being unpatentable over claims 1-2 and 4-7 of U.S. Patent No. 12,552,833 is withdrawn in view of the claim amendments and applicant’s arguments.
Specification
The substitute specification filed 6/11/2026 has been entered.
The replacement sequence listing submitted 6/11/2026 has been entered. SEQ ID NOS: 25-26 have been added.
Drawings
The replacement drawings (sheets 1-56) were received on 6/11/2026. These drawings are acceptable.
Election/Restrictions
Claim 1 is directed to an allowable product. Pursuant to the procedures set forth in MPEP § 821.04(B), claims 19-20, directed to the process of making or using an allowable product, previously withdrawn from consideration as a result of a restriction requirement, are hereby rejoined and fully examined for patentability under 37 CFR 1.104.
Because all claims previously withdrawn from consideration under 37 CFR 1.142 have been rejoined, the restriction requirement as set forth in the Office action mailed on 12/15/2025 is hereby withdrawn. In view of the withdrawal of the restriction requirement as to the rejoined inventions, applicant(s) are advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application. Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
For clarity of the record, the species requirement concerning biomimetic peptide sequences is also withdrawn. The specification defines a “biomimetic sequence” as referring to a sequence that mimics a biological activity or effect of a given moiety.
Claims 1-2 and 3-20 are under consideration.
Claims 1 and 4-16 are allowable.
The prior art of record discloses systems of peptide amphiphiles and peptides; however, the peptides are attached to the peptide amphiphiles. See for example, Pinto et al. (WO 2020/154631, of record), Pinto et al. (U.S. Patent Application Publication 2022/0213141, of record), and Pinto et al. (U.S. Patent No. 12,552,833, of record). The peptides of these systems do not meet the limitations of instant claim 1, part (b).
The prior art to Stupp et al. (U.S. Patent Application Publication 2023/0287045) and Stupp et al. (WO 2021/207460) discloses systems of peptide amphiphiles and free peptides. The free peptide and peptide amphiphile are non-covalently co-assembled within the nanostructure. They are intercalated into peptide amphiphile nanofibers See at least abstract and claims. However, these systems do not meet the limitations of instant claim 1.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 19-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Claim 19 is directed to a method of treating an injury in a subject, comprising providing to the subject the system of claim 1.
Claim 20 is directed to the method of claim 19, wherein the injury comprises a central nervous system injury, optionally wherein the injury comprises a spinal cord injury. Claim 20 is not limited to treating spinal cord injury.
Page 20 of the specification defines “treatment” as complete treatment (e.g., total elimination of the condition, disease, or symptoms thereof). This is considered to mean cure. “Treatment" includes inhibiting the disease, arresting its development, relieving the disease, causing regression, or restoring or repairing a lost, missing, or defective function; or stimulating an inefficient process.
Pages 30-31 define injury as including traumatic and non-traumatic injuries. A traumatic injury refers to an injury caused by trauma, for example trauma such as that caused by an automobile accident, a fall, violence, sports injury, surgical injury, and the like. The injury may be a non-traumatic injury to the CNS (e.g., the brain and/or the spinal cord) or the PNS caused by, for example, cancer, multiple sclerosis, inflammation, arthritis, spinal stenosis, tumors, blood loss, stroke, and the like.
As claims 19-20 do not require any particular therapeutic effect, all therapeutic effects encompassed by “treatment” must be enabled.
Note that claim 19 is directed to treating any type of injury from an abrasion to a detached retina to a broken bone to traumatic amputation of a limb.
Note that claim 1 is not directed to any particular biomimetic sequence. That is, a biomimetic sequence for pepsin (a digestive enzyme protein) would not have been expected to be useful in treating a broken bone, a spinal cord injury, or a CNS injury.
The specification discloses no examples of providing the system of claim 1 (with a peptide amphiphile) or claim 2 (with a nanofiber) to any subject. Note that page 31 of the specification discloses formulating the system for delivery, including by injection, by topical administration, and by applying directed to the site of injury. At least for example, it is unclear if the system will remain intact in the subject following injecting the system of claim 1 or 2 into a subject where parts a) and b) interact non-covalently (claim 1) or electrostatically (see claim 4), long enough to affect treatment. Note that the system and slider peptide are designed for the slider peptide to detach. See at least specification page 21, lines 8-25. Claim 1 requires no particular strength or degree of non-covalent interaction.
At least for example, an injury within the claims is brain tissue destruction caused by a cancer such as glioblastoma. There is no evidence of record or reason to believe that administration of the system of claim 1 will reverse this brain tissue destruction or restore any cognitive or motor losses that occur as a result of this brain tissue destruction. There is no evidence of record or reason to believe that administration of the system of claim 1 will cure this injury.
At least for example, there is no evidence of record or reason to believe that administration of the system of claim 1 will cure multiple sclerosis or reverse nerve damage that has occurred.
At least for example, there is no evidence of record or reason to believe administration of the system of claim 1 will cure spinal stenosis or ameliorate herniated disks or bone spurs that can cause spinal stenosis and spinal cord injury.
The claims are not enabled.
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 2 and 17-18 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 2 is confusing in reciting “the system of claim 1, comprising a plurality of peptide amphiphiles that assemble into a nanofiber.” It appears that applicant intended the system of claim 1 “wherein a plurality of peptide amphiphiles according to part a) are assembled into a nanofiber.” In this case, the slider peptide of claim 1, part b), would be on the surface of the nanofiber. See specification page 29, lines 24-26. The current claim language does not make this clear.
Claims 17-18 do not make clear how the cells are integrated into the system of claim 1. Claim 17 is directed to the system of claim 1, further comprising cells. Claim 18 is directed to the system of claim 17, wherein the cells comprise neurons. Claim 1 indicates how parts a) and b) are associated in the system (i.e. the charged sequence interacts non-covalently with the charged peptide segment). The Merrian-Webster dictionary defines a system as a regularly interacting or interdependent group of items forming a unified whole. Claims 17-18 do not make clear how the cells interact with the components of claim 1 to form a unified whole. Claims 17-18 are confusing. Applicant is reminded that claims 17-18 are product claims and not method claims. Applicant is cautioned against introducing new matter.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 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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