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.
Current Status of 18/549,033
This Office Action is responsive to the election received 18 February 2026.
Claims 1, 3-5, 11, 16, 18-23, 27-33, 37, 39-41, 43, and 45-47 are currently pending.
Election/Restrictions
Applicant's election with traverse of the species below in the reply filed on 18 February 2026 is acknowledged. The elected species is as follows, being compound I-3 of instant claim 40:
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The traversal is on the grounds that, according to Applicant: searching all species within the instant claims would not impose a serious search burden.
This is not found to be persuasive, as there are about 300 specifically enumerated, structurally diverse compounds in the claims, and claim 1 covers at least many thousands of compounds.
The requirement is still deemed proper and is therefore made FINAL.
The elected species have been determined to read on claims 1, 3-5, 16, 18-19, 23, 29, 31, 40, 43, and 45-47.
Claims 11, 20-22, 27-28, 30, 32-33, 37, 39, and 41 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention or species, there being no allowable generic or linking claim.
A search for Applicant’s elected species did not retrieve applicable prior art or double patent art. Therefore, the search was expanded as was necessary to reach the rejections below. MPEP 803.02; Ex parte Ohsaka, 2 USPQ2d 1460, 1461 (Bd. Pat. App. lnt. 1987).
Priority
Applicant’s claim for the benefit of the prior-filed patent applications PCT/US2022/019782 (filed 10 March 2022) and 63/159,258 (filed 10 March 2021) under 35 U.S.C. 119(e), 120, 121, 365(c), or 386(c) is acknowledged.
The Examiner has determined, for the purposes of the instant action, that the effective filing date of the instant claims is 10 March 2022, because sufficient support was not found in earlier-filed documents.
Information Disclosure Statement
The information disclosure statements (IDS) received on 3 October 2025 and 10 February 2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, these information disclosure statements are being considered by the examiner.
Claim Objections
Claim 40 is objected to because of the following informalities: A proper Markush group should have commas separating the alternative members. See MPEP 2173.05(h). Commas should be placed in claim 40 between the alternate chemical structures, and a conjunction should be placed before the final structure. Appropriate correction is required.
Improper Markush Grouping Rejection
Claim 1 is 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 claim 1 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: The compounds within the scope of claim 1 do not contain a constant core structure which a common use would flow from. The required chemical structure of claim 1 (formula I) is shown below. The only consistent part of this structure appears to be two carbon atoms. Rings A and C can each be various, unrelated ring moieties; L1 can be various short O, S, and N-containing moieties; R1 can be a hydrogen atom or an aliphatic group or a ring; L2 and L3 can each independently be a short linker moiety or a ring; each of R3-5 can be a hydrogen atom, an aliphatic group, or form a ring; and Z can be an aliphatic group, an O-linked moiety, or a ring.
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Due to the breadth of compounds that fall within the scope of claim 1, and the lack of any consistent structure between them, these compounds would fall within various, unrelated chemical classifications. The function of the compounds within the scope of claim 1, arising from their structures, would be varied and wholly unrelated in many cases. The compounds falling within the scope of claim 1 do not belong to a recognized chemical class and are not recognized to have an equivalent or similar function.
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.
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.
Claims 1, 3-5, 16, 18-19, 23, 29, 31, 43, and 45-47 are 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 1 states “an R6 group and R’ group are optionally taken together… in addition to the nitrogen”. It is not clear what the term “the nitrogen” is referring to. The same type of problem occurs in the clause that begins with “an R6 and R” group are optionally taken” in claim 1. This renders claims 1, 3-5, 16, 18-19, 23, 29, 31, 43, and 45-47 indefinite. Applicant may choose to amend the indicated portions of claim 1 to remove references to “the nitrogen”.
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, 3-4, 16, 18-19, 23, 29, 43, and 45-47 are rejected under 35 U.S.C. 103 as being unpatentable over:
KLUGE (Cited by Applicant in IDS of 3 October 2025; WO 2018/213150 A1; International Publication Date 22 November 2018).
KLUGE teaches the compound shown below as compound 19ac on page 70 therein. This particular compound does not fall within the instant claims, because it is disclaimed within instant claim 1 in the middle of page 30. KLUGE also teaches pharmaceutical compositions of the compounds therein, including a pharmaceutically acceptable carrier, in claim 11. Claim 12 of KLUGE teaches the treatment of a USP30-mediated disorder using the pharmaceutical compositions therein, and claim 15 of KLUGE teaches the treatment of Alzheimer’s disease using the pharmaceutical compositions therein.
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It would have been obvious to one of ordinary skill in the art before the instant effective filing date, reading the teachings of KLUGE, to immediately envisage homologs of the compound above, including a derivative wherein the t-butyl group is replaced by an isopropyl group, for the purpose of tuning the efficacy of the compound. The artisan would have expected success in this derivatization, because their structural homology would lead one of ordinary skill in the art to expect them to have similar properties. See MPEP 2144.09.
Claims 1, 3-5, 16, 18, 23, 31, 43, and 45-47 are rejected under 35 U.S.C. 103 as being unpatentable over:
ROMERO (Cited by Applicant in IDS of 3 October 2025; WO 2021/050992 A1; International Publication Date 18 March 2021).
ROMERO teaches the compound shown below as compound I-64 on page 67 therein. This particular compound does not fall within the instant claims, because it is disclaimed within instant claim 1 at the top of page 12. ROMERO also teaches pharmaceutical compositions of the compounds therein, including a pharmaceutically acceptable carrier (claim 17). Claim 19 of ROMERO teaches the treatment of a USP30-mediated disorder using the pharmaceutical compositions therein, and claim 21 of ROMERO teaches the treatment of Alzheimer’s disease using the pharmaceutical compositions therein.
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One of ordinary skill in the art would have understood, before the instant effective filing date, that halogen moieties are generally interchangeable and a single halogen replacement with another halogen produces a compound with similar properties. ROMERO acknowledges this knowledge within the art by simply referring to halogens as a group within claim 1.
It would have been obvious to one of ordinary skill in the art reading the teachings of ROMERO, before the instant effective filing date, to immediately envisage a derivative of the compound above, with the fluoro group being replaced by a chloro group. The artisan would have expected success in this replacement, because such a halogen-for-halogen replacement would be understood by one of ordinary skill in the art to yield a compound with very similar properties.
Claims 1, 3-5, 16, 18, 23, 40, 43, and 45-47 are rejected under 35 U.S.C. 103 as being unpatentable over:
ROMERO (Cited by Applicant in IDS of 3 October 2025; WO 2021/050992 A1; International Publication Date 18 March 2021)
in view of:
PATANI (Patani, G. A.; LaVoie, E. J. “Bioisosterism: A Rational Approach in Drug Design” Chem. Rev. 1996, 96, 3147-3176.).
Teachings of ROMERO are discussed above.
ROMERO also teaches the compound shown below as compound I-96 on page 72 therein. This particular compound does not fall within the instant claims, because it is disclaimed within instant claim 1 at the top of page 15. ROMERO also teaches pharmaceutical compositions of the compounds therein, including a pharmaceutically acceptable carrier (claim 17). Claim 19 of ROMERO teaches the treatment of a USP30-mediated disorder using the pharmaceutical compositions therein, and claim 21 of ROMERO teaches the treatment of Alzheimer’s disease using the pharmaceutical compositions therein.
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PATANI generally teaches bioisostere replacements for chemical moieties that were known at the time. PATANI teaches the CF3 group to be a known bioisostere of a methyl group on Page 3152.
It would have been obvious to one of ordinary skill in the art before the instant effective filing date, reading the teachings of ROMERO, to envisage a derivative of the compound above, with the methyl group being replaced by a CF3 group (PATANI), for the purpose of tuning the activity of the compound. The artisan would have expected success in this replacement, because this was a known bioisosteric replacement within the art.
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, 3-5, 16, 18, 23, 31, 43, and 45-46 are rejected on the ground of nonstatutory double patenting as being unpatentable over:
Claims 14, 16-17, and 28 of U.S. Patent No. 11,845,724 (referred to below as the ‘724 patent).
Although the claims at issue are not identical, they are not patentably distinct from each other because: The ‘724 patent teaches the compounds below within claim 28. Claim 14 of the ‘724 patent teaches pharmaceutical compositions of the compounds therein including a pharmaceutically acceptable carrier. Claims 16-17 of the ‘724 patent teach the administration of the pharmaceutical compositions therein for the treatment of USP30-mediated disorders, and specifically a neurodegenerative disease.
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Conclusion
No claims are currently allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN D MCANANY whose telephone number is (571)270-0850. The examiner can normally be reached 8:30 AM - 5:30 PM.
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, ANDREW D KOSAR can be reached at (571)272-0913. 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.
/JDMc/Examiner, Art Unit 1625 /Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625
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