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 .
Objections/Rejections Withdrawn
Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied, and constitute the complete set presently being applied to the instant application.
Response to Arguments
Applicant’s arguments, see Pg 9-10, filed 10/2/2025, with respect to objections regarding hyperlinks in the specification as well as rejections under 35 U.S.C. 102 and double patenting have been fully considered and are persuasive. The objections and rejections of 10/2/2025 have been withdrawn. Please note that there is a new objection below to the specification for a different hyperlink not previously noted in the prior Office Action.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1, 128-133, and 141-144, and the species of SEQ ID NO: 5, in the reply filed on 7/9/2025 is acknowledged.
The elected SEQ ID NO: 5 is free of the art. The closest prior art is WO 2019/084343 A1, which discloses and claims the peptide SEQ ID NO: 37 consisting of RRWARRLAFAFRR and is made up entirely of D amino acids. The difference between SEQ ID NO: 37 and the instant SEQ ID NO: 5 is the addition of “Q”, as shown in SEQ ID NO: 5 here: RRWARRqLAFAFRR (emphasis added). WO 2019/084343 A1 does not teach the instant SEQ ID NO: 5, nor does it make obvious why the addition of “Q” into the middle of the sequence would improve its function. Therefore, it is novel and non-obvious.
In the previous Office Action, the elected species was broadened to include SEQ ID NO: 10, 11, and 23 in addition to the previously selected SEQ ID NO: 5. It is noted that SEQ ID NO: 10, 11, and 23 have been cancelled in the instant application.
In the current Office Action, the elected species has been broadened to include SEQ ID NO: 3-9, 12-22, and 24-29.
Claim Status
Claims 1 and 128-148 are pending under examination. Claims 129 and 134-140 were previously withdrawn as non-elected species (claim 129) and inventions (claims 134-140). Claims 145-148 are new. Claims 1 and 128 are currently amended. Claims 2-127 were previously cancelled.
Priority
The application is the 371 national stage entry of PCT/US2021/018031, filed 2/12/2021, which claims priority to the provisional application 62/976,694, filed 2/14/2020. The priority date of 2/14/2020 is acknowledge.
Information Disclosure Statement
The IDS submitted on 10/2/2025 is being considered.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (see Pg 14, line 36 – www.expasy.org/). Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Interpretation
Percent sequence identity as used in the art rejections below has been established through comparison of sequences consisting of all L or all D amino acids to a reference sequence also consisting of all L or all D amino acids, respectively. In cases where the peptide sequence consists of a mixture of L and D amino acids, such as SEQ ID NO: 15, 16, 28, and 29, percent sequence identity has been stablished through comparison of sequences consisting of majority L or majority D amino acids to a reference sequence also consisting of majority L or majority D amino acids, respectively, and relying on the provided formula 100x (fraction of A/B) on Pg 6, first paragraph of the instant specification.
SEQ ID NO: 24 and 25 are described in the instant specification as being cyclized but the Sequence Listing does not indicate that they are cyclized; for purposes of examination, SEQ ID NO: 24 and 25 have been interpreted to be linear as indicated by the Sequence Listing.
Claim Objections
Claim 144 is objected to because of the following informalities: there are two periods at the end of the claim. Appropriate correction is required.
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, 128, 130-133, and 141-147 rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Wimley et al. (WO 2019/084343 A1, filed 10/25/2018, published 5/2/2019, cited on IDS filed 10/5/2022).
Wimley teaches membrane permeabilizing peptides and antimicrobial peptides, polynucleotides encoding the peptides, compositions and methods of use (Abstract).
Wimley teaches the following polypeptides:
SEQ ID NO: 37 (Table 3, Pg 27; claim 54), which exhibits:
92.9% sequence identity to SEQ ID NO: 3-7
100% sequence identity to SEQ ID NO: 8
100% sequence identity to the instant SEQ ID NO: 9 and 24-25
85.7% sequence identity to the instant SEQ ID NO: 12 and 13
84.6%, rounding to 85%, sequence identity to SEQ ID NO: 15 and 29
SEQ ID NO: 38 (Table 3, Pg 27; claim 54), which exhibits
100% sequence identity to SEQ ID NO: 14 wherein X1 is A, X2 and X3 are R, X4 is absent, X5 is A, X6 is R, and X7 is absent
92.9% sequence identity to the instant SEQ ID NO: 17-21
85.7% sequence identity to the instant SEQ ID NO: 26-27
84.6%, rounding to 85%, sequence identity to SEQ ID NO: 16 and 28
Thus, claim 1 is anticipated.
Regarding claim 128, as described above, Wimley teaches SEQ ID NO: 37 and 38, which exhibit >90% sequence identity to several of the peptides instantly claimed as described above. Additionally, Wimley teaches that these polypeptides are antimicrobial peptides that are capable of disrupting the cellular membrane of multiple pathogens with improve hemocompatibility (e.g., in the presence of human red blood cells, human serum) (Pg 26, lines 2-5; claims 57 and 58). SEQ ID NO: 37 and 38 are both 13 amino acids in length; SEQ ID NO: 37 consists of D-amino acids, and SEQ ID NO: 38 consists of L-amino acids (Table 3; claim 64). Thus, claim 128 is anticipated.
Regarding claim 130, Wimley teaches polynucleotides that encode the polypeptides described (Pg 30, lines 24-27; claim 65). Thus, claim 130 is anticipated.
Regarding claim 131, Wimley also teaches expression vectors containing at least one polynucleotide encoding a peptide of the invention or fragment thereof, for example, an expression vector that includes a polynucleotide encoding one or more peptides of Table 1 or Table 3 (that includes SEQ ID NO: 37 and 38) and variants thereof having at least 85% sequence identity thereto (Pg 31, lines 33-39; claims 66 and 89-90). Thus, claim 131 is anticipated.
Regarding claims 132 and 133, Wimley teaches that the polynucleotides, polypeptides, polypeptide conjugates, and antimicrobial peptides (SEQ ID NO: 37 and 38) described can be prepared as compositions that contain a pharmaceutically acceptable carrier, excipient, or stabilizer known in the art (Pg 35, lines 35-40). A composition comprising the vector is also claimed (claims 67-68).
Additionally, Wimley teaches the pharmaceutical composition can further include an additional agent that serves to enhance and/or complement the desired effect (therapeutic compound; Pg 36, lines 24-25; claim 69). A pharmaceutical composition of AMP may include a second antimicrobial agent, which may be an antimicrobial or antifungal agent (Pg 39, lines 12-34; claims 70-71). Further, the composition comprising an antimicrobial compound incorporated therein or coated thereon may be a medical device, a cuff, a dressing material, a mess, a hernia patch, a wound dressing, a bandage, a syringe, gloves, or a household product, a cosmetic product, a pharmaceutical product, a washing or cleaning formulation, a medical device surface, a medical device material, a fabric, a plastic, a surface of a plastic article, a paper, a nonwoven material, a wood, leather, or a metal surface (claims 80-81). Thus claims 132 and 133 are anticipated.
Regarding claim 141, Wimley claims a kit comprising a polypeptide and optionally an antimicrobial agent (Pg 9, lines 24-26; claim 91). Wimley discloses that kits containing an AMP described include one or more containers comprising, for example, AMPs, polynucleotides encoding one or more AMPs, combinations thereof, and, optionally, instructions for use in accordance with any of the methods described (Pg 46, lines 4-22). Thus claim 141 is anticipated.
Regarding claim 142, Wimley claims a kit wherein said antimicrobial agent is an antibacterial agent or an antifungal agent (claim 92). Thus, claims 142 is anticipated.
Regarding claim 143, Wimley claims a kit wherein said antibacterial agent is polymyxin (claim 93). Thus, claim 143 is anticipated.
Regarding claim 144, Wimley claims a kit wherein said polymyxin is colistin (claim 94). Thus, claim 144 is anticipated.
Regarding claim 145-147, as stated above, Wimley teaches SEQ ID NO: 37, which exhibits 100% sequence identity to the instant SEQ ID NO: 9, 24, and 25, and SEQ ID NO: 38, which exhibits 100% sequence identity to the instant SEQ ID NO: 14 wherein X1 is A, X2 and X3 are R, X4 is absent, X5 is A, X6 is R, and X7 is absent. Thus, claims 145-147 are anticipated.
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, 128, 132-133, 141-142, and 145-147 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6-8, and 11-12 of U.S. Patent No. 11,266,743 (US ‘743). Although the claims at issue are not identical, they are not patentably distinct from each other because they contain overlapping subject matter.
Claim 1 of U.S. Patent No. ‘743 recites a polypeptide, wherein the polypeptide: a) has at least 85% sequence identity to the sequence of any one of SEQ ID NOS: 3-10; or b) has at least 85% sequence identity to the sequence of any one of SEQ ID NOS: 19-42.
The instant SEQ ID NO: 3-9, 12-21, and 24-29 exhibit at least 85% or greater sequence identity to SEQ ID NO: 37 and or 38 of US ‘743, as described above.
Dependent claims of U.S. Patent No. ‘743 include other characteristics of the polypeptide (claim 12), a composition comprising the polypeptide thereof (claims 6-8), and a kit thereof (claim 11).
Allowable Subject Matter
A polypeptide having at least 95% sequence identity to any one of SEQ ID NO: 3-7 and 17-21 is free of the art.
A polypeptide having at least 90% sequence identity to any one of SEQ ID NO: 12, 13, 15, 16, and 26-29 is free of the art.
The closest art is either SEQ ID NO: 37 or SEQ ID NO: 38 of WO 2019/084343 A1 (published 5/2/2019), as described above in the art rejections.
A polypeptide having at least 85% sequence identity to SEQ ID NO: 22 is free of the art. The closest art is SEQ ID NO: 1891 of US20110265221A1 (filed 3/25/2011), which exhibits 58.3% sequence similarity to SEQ ID NO: 22.
Claim 148 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
No claim is allowed.
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/SARA E KONOPELSKI SNAVELY/Examiner, Art Unit 1658
/FRED H REYNOLDS/Primary Examiner, Art Unit 1658