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Objections/Rejections Withdrawn
Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn.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 31-32, filed 6/22/2026, with respect to the rejections of the claims under double patenting have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of amendment.
Election/Restrictions
From the prior Office Action dated 2/20/2026: 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)).
All the claims from the previously examined claim set have been cancelled and new claims have been submitted as of 6/22/2026. Based upon Applicant’s original election, new claims 28-43 and 46-50 are currently under examination, and the remaining claims are withdrawn; see Claim Status below.
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 28-52 are new and pending. Claims 1-27 are cancelled. Based upon the previous Restriction/Election Requirement, claims 44-45 and 51-52 are hereby withdrawn as non-elected inventions.
Information Disclosure Statement
The IDS submitted on 7/16/2026 is under consideration.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 48 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 48 recites the pharmaceutical composition according to claim 42, wherein the compound is defined as in claim 28. However, claim 42 depends from claim 28 and recites a pharmaceutical composition containing the compound of formula (I) or a mixture of compounds there of as defined in claim 28 and at least one pharmaceutically inert carrier; thus, claim 48 does not further limit claim 42 from which it depends. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 28-34, 36-37, 39-43, and 46-50 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 23-28, 30-33, 40-41, 43, 46, 48-50, 52, and 55 of copending Application No. 18/019,388 (‘388, reference application; claim set filed 6/10/2026). 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 anticipate the species of copending Application No. ‘388. Further dependent claims of copending Application No. ‘388 also include enantiomers and pharmaceutical compositions thereof as well as methods of use and administration.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 28-32, 41-43, and 46-50 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 and 11-17 of copending Application No. 18/294,227 (‘227, reference application; claim set filed 6/26/2026). 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 anticipate the species of copending Application No. ‘227. Further dependent claims of copending Application No. ‘227 also include enantiomers, pharmaceutical compositions, and medicaments thereof.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Allowable Subject Matter
As stated in the prior Office Action, the species recited in claims 28-40 (which correspond to cancelled claims 1-15, respectively) are 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 species are 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 species, thereby making them novel and non-obvious.
The new, additional species recited in claims 46 and 47 are additionally free of the art.
Conclusion
No claim is allowed.
Claims 28-34, 36-37, 39-43, and 46-50 are rejected.
Claims 35 and 38 are objected to for depending on a rejected claim.
Claims 44, 45, 51, and 52 are withdrawn.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 Sara Konopelski Snavely whose telephone number is (571)272-1841. The examiner can normally be reached Monday - Friday 9-6pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melissa L 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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/SARA E KONOPELSKI SNAVELY/Examiner, Art Unit 1658
/Melissa L Fisher/Supervisory Patent Examiner, Art Unit 1658
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