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 .
Examiner’s Note
This Office Action, updated 2/13/2026, replaces the prior Office Action, dated 1/26/2026. The prior Office Action objected to the specification and the claims due to a lack of SEQ ID NO’s; however, as pointed out by Applicant’s representative, Agent Zhan, the inclusion of one D-amino acid in all of the sequences set forth in the specification and claims obviates the need under ST.25. Therefore, the current Office Action does not include any sequence compliance objections that were previously included in the prior Office Action (also see Interview Summary attached). The outstanding rejections remain unchanged.
Election/Restrictions
Applicant’s election of Group I, claims 1-20, and the species Example 55, in the reply filed on 10/27/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Example 55 was found to be free of the art. The closet prior art is Vetterli et al. (Thanatin targets the intermembrane protein complex required for lipopolysaccharide transport in Escherichia coli. Sci Adv. 2018 Nov 14;4(11):eaau2634.), which discloses the peptide sequence of thanatin, from which the instant Example 55 is derived, as well as general structural information about how thanatin interacts with LptA. There are no teachings, suggestions, or motivations within Vetterli that that would lead one skilled in the art to alter the disclosed sequence/structure of thanatin to arrive at the instant Example 55, thereby making it novel and non-obvious.
Accordingly, the species election was broadened to include the other species recited in claim 15 and, subsequently, those recited in claims 1-14. These species were also found to be novel and non-obvious over the closest prior art, which is still Vetterli.
However, although the species are free of the art, other objections and rejections have been raised below that prevent any claim from being allowable.
Priority
The instant application is the 371 national stage entry of PCT/EP2021/025302, filed 8/5/2021, which claims priority to EP20020354.5, filed 8/5/2020. The priority date of 8/5/2020 is acknowledged.
Claim Status
Claims 1-27 are pending. Claims 21-27 are hereby withdrawn as non-elected inventions). Claims 3 and 5-27 are currently amended.
Information Disclosure Statement
The IDS’s submitted on 6/8/2023 and 7/16/2024 are under consideration.
Claim Objections
Claim 9 is objected to because of the following informalities:
Regarding claim 9, the claim recites that position p16 can be “Nle, Cha, orTyr” where there is no space between “or” and “Tyr”.
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 18 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 18 recites the pharmaceutical composition according to claim 17 in a form suitable for oral, topical, transdermal, injection, buccal, transmucosal, rectal, pulmonary or inhalation administration, especially in the form of a tablet, a dragee, a capsule, a solution, a liquid, a gel, a plaster, a cream, an ointment, a syrup, a slurry, a suspension, a spray, a nebulizer, an aerosol, or a suppository (emphasis added). The scope of this claim is indefinite as it is unclear whether the pharmaceutical composition may be any form suitable for oral, topical, transdermal, injection, buccal, transmucosal, rectal, pulmonary or inhalation or may only be selected from a tablet, dragee, capsule, solution, liquid, gel, plaster, cream, ointment, syrup, slurry, suspension, spray, nebulizer, aerosol, or suppository. For instance, a transdermal patch would fall within the scope of the first half of the claim, which specifies only the route of administration for which the composition should be formulated, but would not fall within the scope of the specific formulations listed in the second half of the claim.
For purposes of examination, the claim is being interpreted to be any form suitable for oral, topical, transdermal, injection, buccal, transmucosal, rectal, pulmonary or inhalation administration.
Improper Markush
Claims 1-8 and 16-20 are rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping of claims 1-8 is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons: there is no core structure or sequence.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
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.
Claim 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of copending Application No. 18/019,388 (‘388, reference application; claim set filed 2/7/2023). Although the claims at issue are not identical, they are not patentably distinct from each other because they contain overlapping subject matter.
Claims 1-10 of copending Application No. ‘388 recite various antimicrobial peptidomimetic species; the species of the instant claims 1-15 anticipate the aforementioned species of claims 1-10 in copending Application No. ‘388. Further dependent claims of copending Application No. ‘388 also include enantiomers and pharmaceutical compositions thereof (claims 11-15).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 1-7 and 16-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 and 11-17 of copending Application No. 18/294,227 (‘227, reference application; claim set filed 2/1/2024). Although the claims at issue are not identical, they are not patentably distinct from each other because they contain overlapping subject matter.
The species of the instant claims 1-7 anticipate the species of claims 1-9 in copending Application No. ‘227. Further dependent claims of copending Application No. ‘227 also include enantiomers, pharmaceutical compositions, and medicaments thereof (claims 11-17).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Sara E Konopelski Snavely whose telephone number is (571)272-1841. The examiner can normally be reached Monday - Friday 9-6pm EST.
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/SARA E KONOPELSKI SNAVELY/Examiner, Art Unit 1658
/FRED H REYNOLDS/Primary Examiner, Art Unit 1658