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 . 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.
Election/Restrictions
Applicants elected the sequence P50 with traverse in the reply filed on 15 Sept, 2025. The traversal was found unpersuasive, and the election/restriction requirement made final in the office action of 7 Oct, 2025.
Claims Status
Claims 1-17 are pending.
Claims 1, 8, 13, and 14 have been amended.
Claim 17 is new.
Claims 3, 6, and 13 have been withdrawn from consideration due to an election/restriction requirement.
Withdrawn Objections
The objection to the disclosure due to lack of SEQ ID numbers is hereby withdrawn due to amendment.
New Objections
The amendment filed 27 Jan, 2026 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows: on p42, compound p36 (SEQ ID 60) has been modified so the C-terminal dichlorophenylalanine has been modified to an o-methyl p-chloro phenylalanine, for which there is no support in the application as filed.
Applicant is required to cancel the new matter in the reply to this Office Action.
Withdrawn Rejections
The rejection of claim 8 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite due to ‘preferably’ language is hereby withdrawn due to amendment.
Maintained/Modified Rejections
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 2, 4, 5, 7-12, and 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over Burnouf et al (WO 2012140619, cited by applicants) in view of Fiacco et al (Chembiochem (2008) 9(14) p2200-2203).
Burnouf et al discuss new antibiotic compounds (p2, 3d paragraph). The variant with the highest affinity is sequence P14, Ac-Q-Cha-DL-DiClF (table 7, p27, top of page); identical with peptide P35 of the examined claims save that it does not have a methyl group on the aspartic acid amine group. This sequence was crystalized with its binding partner for X-ray structure determination (p28, 2nd paragraph). Note that claims 15 and 16 of the reference state that these compounds can be made up as a pharmaceutical composition, and used as an antibacterial agent (which would require administration).
The difference between this reference and the examined claims is that the examined claims explicitly exclude this sequence, and some of the examined claims describe this sequence modified by an N-methyl group on the Asp residue.
Fiacco et al discuss N-methyl scanning for derivatives with improved affinity, selectivity, and protease resistance (title). To find the sequence with the best properties, each single N-methyl variant was synthesized (1st page, 2nd paragraph), and tested for protease sensitivity (1st page, 3d paragraph, continues to 2nd page, 1st paragraph). It was noted that the methylation does not need to be at the cleavage site to have a beneficial effect, but merely needs to be in the general area (2nd page, 1st paragraph). The affinity of the variants was also tested, with one variant proving to have significantly improved affinity compared to the unmodified sequence (2nd page, 2nd paragraph). Finally, binding to related targets was examined to determine specificity (2nd page, 5th paragraph). Many of the modified sequences had improved selectivity (2nd page, 5th paragraph). This reference discusses N-methyl scans to search for derivatives with improved protease resistance, affinity, and selectivity.
Therefore, it would be obvious to synthesize each N-methyl derivative of the peptides of Burnouf et al, to find derivatives with improved protease resistance, affinity, and selectivity. As this is a common peptide modification, an artisan in this field would attempt this modification with a reasonable expectation of success.
Burnouf et al discuss sequences identical to P35, save for the N-methyl group at the Asp residue. Fiacco et al discuss scanning the various N-methyl derivatives to find variants with improved properties, which will necessarily include the variant with the Asp residue methylated. Thus, the combination of references renders obvious claims 1, 2, 4, 5, 7-12, 14, and 17.
Burnouf et al mentions pharmaceutical compositions of the sequences, rendering obvious claim 15.
Burnouf et al discusses use of the sequences to treat bacterial infections, rendering obvious claim 16.
response to applicant’s arguments
Applicants argue that Fiacco et al is not discussing antimicrobial sequences, that modification of the Asp residue gave inferior performance, and that there is no reason to modify the sequence of Burnouf et al.
Applicant's arguments filed 27 Jan, 2026 have been fully considered but they are not persuasive.
Applicants argue that Fiacco et al is not discussing antimicrobial sequences. This is an argument of non-analogous art. A reference is analogous if it is in the same field of endeavor as the claimed invention (even if it addresses a different problem) OR the reference is reasonably pertinent to the problem faced by the inventor. Applicants are improving the sequences of Burnouf et al; a reference that discusses potential modifications to improve plasma lifetime, affinity, and selectivity is clearly pertinent to that problem.
Applicants further argue that the modification made by applicants, methylation of the Asp residue, was demonstrated by Fiacco et al to be detrimental. However, applicants have not explained why a person of skill in the art would expect that results of a modification of an entirely different sequence that binds to an entirely different receptor could be extrapolated to the sequences of Burnouf et al.
Finally, applicants argue that there is no reason to modify the sequence of Burnouf et al. However, as noted in the rejection, the authors of that paper generated a crystal of the peptide and its receptor; a feat that takes considerable effort. This indicates that this sequence was important to the authors. Note that the sequence is explicitly claimed (claim 13), further supporting the conclusion it was important.
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, 2, 4, 5, 7-12, and 14-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 13, 15, and 16 of U.S. Patent No. 9,133,240 in view of Fiacco et al (Chembiochem (2008) 9(14) p2200-2203).
Competing claim 1 describes a genus of sequences that are a subset of those of the examined claims. Competing claim 13 gives a Markush group of sequences, including Ac-Q-Cha-DL-DiClF. As this is sequence is explicitly claimed, it is reasonable to assume it was important for the authors of the document, hence a reasonable starting point for further optimization. Competing claim 15 specifies a pharmaceutical composition, while competing claim 16 describes a method of treating a bacterial infection, comprising administering a compound of the invention.
The difference between the competing claims and the examined claims is that the competing claims explicitly exclude this sequence, and do not describe an N-methyl variant of this sequence.
Fiacco et al discuss N-methyl scanning for derivatives with improved affinity, selectivity, and protease resistance (title). To find the sequence with the best properties, each single N-methyl variant was synthesized (1st page, 2nd paragraph), and tested for protease sensitivity (1st page, 3d paragraph, continues to 2nd page, 1st paragraph). It was noted that the methylation does not need to be at the cleavage site to have a beneficial effect, but merely needs to be in the general area (2nd page, 1st paragraph). The affinity of the variants was also tested, with one variant proving to have significantly improved affinity compared to the unmodified sequence (2nd page, 2nd paragraph). Finally, binding to related targets was examined to determine specificity (2nd page, 5th paragraph). Many of the modified sequences had improved selectivity (2nd page, 5th paragraph). This reference discusses N-methyl scans to search for derivatives with improved protease resistance, affinity, and selectivity.
Therefore, it would be obvious to synthesize each N-methyl derivative of the peptides of the competing claims, to find derivatives with improved protease resistance, affinity, and selectivity. As this is a common peptide modification, an artisan in this field would attempt this modification with a reasonable expectation of success.
response to applicant’s arguments
Applicants have pointed to their arguments with respect to the rejection under 35 USC 103, above, which were answered there.
Conclusion
THIS ACTION IS MADE FINAL. 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 FRED REYNOLDS whose telephone number is (571)270-7214. The examiner can normally be reached M-Th 9-3:30.
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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.
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/FRED H REYNOLDS/Primary Examiner, Art Unit 1658