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 .
Response to Election/Restriction filed on March 16, 2026 is acknowledged.
Claims 1-20 are pending in this application.
Restriction
Applicant’s election without traverse of Group 1 (claims 1-8) and the election with traverse of SEQ ID NO: 14 as the species of the helical filament hexapeptide (PHF6) in the reply filed on March 16, 2026 is acknowledged. Applicant argues that for the election of species, Applicant does not believe that the further election of “a single disclosed species of a dipeptide at the C-terminal end of the N-amino peptide” is necessary or consistent with the current election of compound 12 (SEQ ID NO: 14) because the election of a dipeptide may require the election of a second and distinct species with respect to a PHF6 peptide sequence. This is found persuasive, thus, claims 7-8 are withdrawn from further consideration as being drawn to nonelected species. Restriction requirement is deemed to be proper and is made FINAL in this office action. Claims 9-20 are withdrawn from consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions, there being no allowable generic or linking claim. The elected species has been searched. A search was conducted on the elected species, and prior art was found. Claims 1-6 are examined on the merits in this office action.
Objections
The drawings are objected to because some of the drawings contain shadings that makes the figures hard to see (see for example, Fig. 1A, Fig. 6, Fig. 7). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
Rejections
35 U.S.C. 112(b)
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 1-3 and 5-6 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 recites, “An N-amino peptide…wherein one or more amino acid moieties of the PHF6 have…” The term “one or more amino acid moieties” is indefinite because it is unclear what is encompassed within the term “one or more”. The specification does not clearly define what is encompassed within the term “one or more”. Because claims 2-3 and 5-6 depend from indefinite claim 1 without clarifying the point of confusion, these are also rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph.
Claim 2 recites, “The N-amino peptide of claim 1 comprising Formula 1:
PNG
media_image1.png
244
482
media_image1.png
Greyscale
. It is unclear from the claims whether R2 is the amino acid isoleucine or valine and R3 is the amino acid asparagine or tyrosine or R2 is the side chain (functional group) representing the amino acid isoleucine or valine and R3 is the side chain (functional group) representing the amino acid asparagine or tyrosine). The metes and bounds of the claim is unclear.
U.S.C. 102
10. 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.
11. 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.
12. Claim(s) 1-6 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by MedChemExpress (www.MedChemExpress.com, p. 1, Product Data Sheet, October 20, 2021).
13. MedChemExpress teaches that elected species peptide sequence Ac-Val-Gln-aIle-Val-aTyr-Lys-NH2 (see sequence shortening on page 1). MedChemExpress teaches that the Ile and Tyr both have hydrazide (NNH2) moieties. Since MedChemExpress teaches the elected species, and that the species has hydrazide moiety (NNH2) at the Ile and Tyr residues, the reference anticipates instant claims 1-6.
14. Claims 1-6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Makwana et al (ACS Chem. Neurosci., October 20, 2021, 12(20): 3928-3938, filed with IDS).
15. Makwana et al teach the elected peptide species of instant SEQ ID NO: 14 (see p. 3929, Figure 2), meeting the limitation of instant claim 6. Makwana et al teach the hexapeptides VQIINK (PHF6*) and VQIVYK (PHF6) (see p. 3928, Introduction). Meeting the limitation of instant claims 1-3. Makwana et al teach the hydrazide moieties for hexapeptides AcPHF6 and AcPHF6* (see p. 3930, 1st full paragraph, 2nd full paragraph) and compounds 12 and 13 feature two hydrazide bonds within the peptideommetic backbone (see p. 3931, Di-NPAs Are Stable in Human Serum and Non-toxic to Neuronal Cells), meeting the limitation of instant claims 1-5. Since Makwana et al teach all of the active components of instant claims, the reference anticipates instant claims 1-6.
16. Claims 1-6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Makwana et al (https://doi.org/10.26434/chemrxiv.14478225.v1, pp. 1-10, April 26, 2021).
17. Makwana et al teach the elected peptide species of instant SEQ ID NO: 14 (see Figure 2, compound number 12) meeting the limitation of instant claim 6. Makwana et al teach the peptide sequence VQIINK (PHF6*) and VQIVYK (PHF6) (see p. 2, left column), meeting the limitation of instant claims 1-3. Makwana et al teach that compounds 12 and 13 feature two hydrazide bonds within the peptidomimetic backbone (see p. 5, right column). Since Makwana et al teach all of the active components of instant claims, the reference anticipates instant claims 1-6.
18. Claim(s) 1-6 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Del Valle et al (US 2024/0116984).
The applied reference has a common Inventors (Juan Del Valle and Kamlesh Makwana) and assignee (University of Notre Dame du Lac) with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
19. Del Valle et al teach the N-amino peptides (NAPs) that inhibit disease-associated tau aggregation and prevent fibril formation. The NAPs have the sequence VQIINK and VQIVYK (see abstract, for example), meeting the limitation of instant claims 2-3. Del Valle et al teach instant SEQ ID NO: 14 (see FIG. 2B, compound 12 or FIG. 3, compound 12, and claim 19), meeting the limitation of instant claims 1-6. Since Del Valle et al teach all of the active components of instant claims, Del Valle et al anticipates instant claims 1-6.
DOUBLE PATENTING
20. 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.
21. Claims 1-6 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-2 and 6-21 of copending Application No. 18/263190 (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 Application and vice versa.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. (Please note: a notice of allowability was issued on 3/30/2026 for the copending application No. 18/263190; however, the patent has not been issued as of 5/25/2026).
22. Instant claims are drawn to:
PNG
media_image2.png
670
568
media_image2.png
Greyscale
PNG
media_image3.png
472
586
media_image3.png
Greyscale
.
23. The copending claims are drawn to:
PNG
media_image4.png
702
592
media_image4.png
Greyscale
PNG
media_image5.png
682
606
media_image5.png
Greyscale
PNG
media_image6.png
674
578
media_image6.png
Greyscale
PNG
media_image7.png
548
546
media_image7.png
Greyscale
.
24. Instant claims and copending claims share the same compounds, i.e., for example, SEQ ID NO: 14, which is Ac-Val-Gln-aIle-Val-aTyr-Lys-NH2 (SEQ ID NO: 18) and similar scope of general compounds. 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.
CONCLUSION
No claim is allowed.
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
5/25/2026
Prosecution Insights