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
In claim set filed June 18th, 2026, applicant canceled claims 1-3, 5-7, 11, 14, 15, 17, 18, 22, 26, 36, 43-45, 49, 53, and 63 and added new claims 64-80.
Applicant’s election without traverse of Group III, directed to claims 64-68, in the reply filed on June 18th, 2026 is acknowledged.
Claims 69-80 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on June 18th, 2026.
Priority
The instant application claims priority to 371 National Stage Application PCT/US22/26539, filed April 27th, 2022, under 35 U.S.C. 119(a)-(d), and claims benefit to provisional applications 63180416, filed April 27th, 2021 and 63225261, filed July 23rd, 2021, under 35 U.S.C.119 (e). The priority date of April 27th, 2021 is acknowledged.
Information Disclosure Statement
The information disclosure statements (IDS) filed on January 30th, 2024, February 25th, 2025, December 3rd, 2025, and March 25th, 2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claims Status
The claims listing filed on June 18th, 2026 is pending. Claims 69-80 are withdrawn from further consideration for the reasons set forth in the restriction requirement, 37 CFR 1.142(b). Claims 64-68 are being examined on the merits in this office action.
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 64-67 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 9-10 and 22 of copending Application No. 18017582 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application’s method claims use a peptide that reads on the peptide in the instant application
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Regarding claim 64, ‘582 claims,
A method of treating or preventing a coronavirus infection, the method comprising administering to a subject in need thereof a peptide comprising the amino acid sequence of SEQ ID NO: 1 or a variant thereof comprising one, two, or three amino acid substitutions, wherein the administration is via intranasal or pulmonary routes of administration [claim 1].
Instant SEQ ID NO: 88 is a variant of ‘582’s SEQ ID NO: 1 with three amino acid substitutions at D5A, C11S, and K18R. Therefore, prior to the effective filing date, it was obvious to claim a peptide comprising the sequence SWLRAIWDWISEVLSDFR.
Regarding claim 65, ‘582 goes on to claim:
A method of treating or preventing a coronavirus infection, the method comprising administering to a subject in need thereof a peptide comprising the amino acid sequence of SEQ ID NO: 1 or a variant thereof comprising one, two, or three amino acid substitutions, wherein the administration is via intranasal or pulmonary routes of administration, wherein the peptide is modified with a lipophilic moiety via a linker bonded to a lysine, serine, or cysteine of the peptide or variant. [claims 1 and 4].
Therefore, prior to the effective filing date, it was obvious to claim a peptide comprising the sequence SWLRAIWDWISEVLSDFR, wherein the peptide is modified with a lipophilic moiety via a linker bonded to a lysine, serine, or cysteine of the peptide or variant.
Regarding claim 66, ‘582 goes on to claim:
A method of treating or preventing a coronavirus infection, the method comprising administering to a subject in need thereof a peptide comprising the amino acid sequence of SEQ ID NO: 1 or a variant thereof comprising one, two, or three amino acid substitutions, wherein the administration is via intranasal or pulmonary routes of administration, wherein one or more amino acids of the peptide are D- amino acids. [claims 1 and 22].
Therefore, prior to the effective filing date, it was obvious to claim a peptide comprising the sequence SWLRAIWDWISEVLSDFR, wherein one or more amino acids of the peptide are D-amino acids.
Regarding claim 67, ‘582 goes on to claim:
A method of treating or preventing a coronavirus infection, the method comprising administering to a subject in need thereof a peptide comprising the amino acid sequence of SEQ ID NO: 1 or a variant thereof comprising one, two, or three amino acid substitutions, wherein the administration is via intranasal or pulmonary routes of administration, wherein one or more amino acids of the peptide are D- amino acids. [claims 1-22].
Therefore, prior to the effective filing date, it was obvious to claim a peptide comprising the sequence SWLRAIWDWISEVLSDFR, wherein one amino acid of the peptide is a D-amino acid.
Claim Objections
Claim 68 is objected to for dependency on rejected base claim 64.
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.
Claim 65 is 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 65 recites the limitation "or variant" in line 3. There is insufficient antecedent basis for this limitation in the claim. This limitation renders the claim indefinite because it is unclear what the “or variant” refers to as there is not previously stated variant and if it is then modifying the scope of the claim to include variants of instant SEQ ID NO: 88.
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter: A peptide comprising the sequence SWLRAIWDWISEVLSDFR (SEQ ID NO: 88) is found to be allowable over the closest prior art, Cheng et al. (G. Cheng, A. Montero, P. Gastaminza, C. Whitten-Bauer, S.F. Wieland, M. Isogawa, B. Fredericksen, S. Selvarajah, P.A. Gallay, M.R. Ghadiri, & F.V. Chisari, A virocidal amphipathic α-helical peptide that inhibits hepatitis C virus infection in vitro, Proc. Natl. Acad. Sci. U.S.A. 105 (8) 3088-3093, (2008)) and UniProt Accession Numbers K7XQR2, C5ISF6, and A0A3G1C238.
Cheng et al. teach a peptide derived from the membrane anchor domain of the hepatitis C virus (HCV) NS5A protein, C5A, that is virocidal for HCV at a sub micromolar concentration in vitro [Abstract line 1]. Instant SEQ ID NO: 88 differs from C5A with at D5A, C11S and K18R substitutions. Cheng et al. also performs structure-activity analysis of C5A antiviral activity. To determine whether the antiviral activity strictly depends on amino acid composition, they compared the activity of several C5A analogues from six HCV genotypes whose amino acid sequences and compositions are not strictly conserved [pg 3090 pgh 5 line 1 and Table 1]. Of these genotypes, peptide No. 31 comprises of the D5A substitution [see Table below]. However, that genotype also comprises of other substitutions, and had a low viral activity. Cheng et al. also performed the C11S substitution, but the resulting peptide also has low virocidial activity [peptide 34]. Cheng et al. does not teach the K18R substitution.
PNG
media_image1.png
784
612
media_image1.png
Greyscale
However, there are HCV NS5A sequences that individually comprise of the D5A, C11S, and K18R substitutions:
K7XQR2
PNG
media_image2.png
75
388
media_image2.png
Greyscale
C5ISF6
PNG
media_image3.png
71
390
media_image3.png
Greyscale
A0A3G1C238
PNG
media_image4.png
75
386
media_image4.png
Greyscale
Still, a peptide comprising SEQ ID NO: 88 is deemed allowable subject matter because there is no corresponding literature that motivates combining the substitutions or their strengths individually and because Cheng et al does not specifically teach the D5A substitution but rather teaches an analogue comprising the substitution with four other modifications. Nor, would one of ordinary skill be motivated to make the instant SEQ ID NO: 88 because the peptide comprising the alanine and serine substitutions had poor virocidal activity. Thus, a peptide comprising SEQ ID NO: 88 is allowable subject matter.
Claim 68 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Claims 64-67 are provisionally rejected on the ground of nonstatutory double patenting. Claim 65 is rejected under 35 U.S.C. 112(b). Claim 68 is objected to for dependency on a rejected base claim.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SACHI JAUHARI whose telephone number is (571)272-3769. The examiner can normally be reached Mon-Fri 9-4.
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.
/SACHI JAUHARI/ Examiner, Art Unit 1654
/LIANKO G GARYU/ Supervisory Patent Examiner, Art Unit 1654
Prosecution Insights