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 .
DETAILED ACTION
Claim Status
Claims 38-46 are pending. Claims 33-37 and 47-52 have been canceled. Claims 38 and 42 have been amended. Claims 38-41 are being examined in this application. In the response to the restriction requirement, Applicants elected Group I, SEQ ID NO: 32, cholesterol and PEG4. Claims 42-46 are withdrawn as being drawn to a nonelected invention.
Claim Rejections - 35 USC § 112
The rejection of claims 33-41 under 35 USC 112(a) is withdrawn in view of the amendments to the claims.
Claim Rejections - 35 USC § 102
The rejection of claims 33-41 under 35 U.S.C. 102(a)(1) as being anticipated by Xia et al. is withdrawn in view of the amendments to the claims.
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)(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 38-41 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Walensky et al. (WO 2021/178714).
With respect to claims 38-39, Walensky et al. teach a structurally-stabilized polypeptide comprising the sequence IQKEIDRLNEVAKNLNESL (claim 1), wherein the structurally-stabilized polypeptide further comprises the amino acid sequence DISGINASVVN appended at the N-terminus of the amino acid sequence (claim 9), wherein the structurally-stabilized polypeptide further comprises the amino acid sequence IDLQELGSGSGC appended at the C-terminus of the amino acid sequence (claim 12), and wherein the structurally-stabilized polypeptide further comprises cholesterol (claim 15).
With respect to claims 40-41, Walensky et al. teach that the structurally-stabilized polypeptide further comprises polyethylene glycol (claims 14 and 16).
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 is a new rejection.
Claims 38-41 are rejected under 35 U.S.C. 103 as being unpatentable over Tripet et al. (WO 2005/077103) in view of Porotto et al. (US 2017/0216448).
Tripet et al. teach a composition comprising a purified peptide of a SARS coronavirus S protein, wherein said peptide is capable of modification of SARS coronavirus infectivity (claim 1), and wherein the peptide is HR-C1 (SEQ ID NO: 40; DLGDISGINASVVNIQKEIDRLNEVAKNLNESLIDLQEL) (claims 5, 16 and 18; para [0022]; Fig. 19), which reads on amino acids 1-36 of instant SEQ ID NO: 32 (DISGINASVVNIQKEIDRLNEVAKNLNESLIDLQELGSGSGC).
Tripet et al. further teach that “[A]ny of the peptides described herein may, additionally, have a non-peptide macromolecular carrier group covalently attached to their amino and/or carboxy termini. Such macromolecular carrier groups may include, for example, lipid-fatty acid conjugates, polyethylene glycol, or carbohydrates” (para [0179]).
Tripet et al. do not teach using the linker GSGSGC to link the peptide with a lipid.
Porotto et al. teach an inhibitor of fusion between a viral membrane from an enveloped virus and a cell membrane, wherein the viral membrane comprises a fusion mediating protein including a C-terminal peptide (claim 1; abstract).
Porotto et al. also teach that a C-terminal extension with the GSGSG linker/spacer sequence and a cysteine residue (i.e. GSGSG-C), allows for conjugation to cholesterol via thiol-reactive reagents (para [0101]).
Porotto et al. further teach that “[T]he importance of the spacer linker between the viral peptide fusion inhibitor and the membrane binding lipid can be demonstrated by observing the changes in the antiviral efficacy first when a spacer is added to a peptide conjugated with a lipid, and second as the size of this spacer increases (para [0123]).
Porotto et al. additionally teach that modulation of lipid moiety and/or PEG linker peptide improved antiviral potency and in vivo biodistribution (para [0138]).
It would have been obvious to one of ordinary skill in the art to use the linker of Porotto et al. (i.e. GSGSG-C) to link the peptide of Tripet et al. with a macromolecular carrier group, such as lipid-fatty acid conjugates, polyethylene glycol, etc. because Porotto et al. teach that GSGSG-C allows for conjugation to cholesterol via thiol-reactive reagents, and further teach that modulation of lipid moiety and/or PEG linker peptide improved antiviral potency and in vivo biodistribution.
One of ordinary skill in the art would have reasonably expected the resulting peptide (i.e. instant SEQ ID NO: 32 conjugated to a lipid) to have improved antiviral potency and in vivo biodistribution.
With respect to claim 39, as discussed above, Porotto et al. teach that the lipid is cholesterol.
With respect to claims 40-41, Porotto et al. teach that GSGSG-C is linked to cholesterol via a PEG4 linker (see Table 1).
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 38-41 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 7, 16-18, 20-21, 23-25, 30, 33, 35, 39, 43 and 46 of copending Application No. 19/020996 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they relate to the same fusion inhibitor.
‘0096 teaches the lipopeptide of formula A, which comprises the sequence DISGINASVVNIQKEIDRLNEVAKNLNESLIDLQELGSGSG linked via a cysteine residue to PEG-cholesterol (see claim 30).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SERGIO COFFA whose telephone number is (571)270-3022. The examiner can normally be reached M-F: 6AM-4PM.
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, 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.
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.
/SERGIO COFFA Ph.D./
Primary Examiner
Art Unit 1658
/SERGIO COFFA/Primary Examiner, Art Unit 1658