DETAILED ACTION
Claims 1-20, submitted on March 22, 2024, are pending in the application. Claims 18-20 are withdrawn. Claims 1-17 are rejected for the reasons set forth below. No claim is allowed.
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 Leahy-Smith America Invents Act (AIA ), Public Law 112-29, 125 Stat. 284. 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.
Elections/Restrictions
Applicant’s election with traverse of Group I, drawn to a compound or a pharmaceutical composition thereof, in the reply filed on June 11, 2026 is acknowledged. The traversal is on the grounds that that the examiner has not established that the two Groups are independent and distinct. See applicant’s Remarks, submitted June 11, 2026, at pp. 2-3. This is not found persua-sive because it has long been Office policy that a “composition and the process in which the composition is used” are restrictable. See MPEP 802.01 (Meaning of “Independent” and “Distinct”). The claims at issue include two inventions: Group I, drawn to a composition, and Group II, drawn to a process (or method) in which that composition is used. Current Office policy for establishing that these two Groups are restrictable is set forth in MPEP 806.05(h), which explains that “[a] product and a process of using the product can be shown to be distinct inven-tions if either or both of the following can be shown: (A) the process of using as claimed can be practiced with another materially different product; or (B) the product as claimed can be used in a materially different process.” In the present situation, the method as claimed can be practiced with materially different compounds, including those disclosed in WO 2023/223055 A1 by Kirkham et al., discussed below. Group I and Group II are therefore distinct. A search burden exists because examination of the Groups together will require two different searches of the prior art: Group I will require a search in respect of the chemical compounds, and Group II will require a different search in respect of PLpro inhibitors. These two searches are not the same thing. Applicant mischaracterizes the examiner’s burden by stating that “as claim 1 is directed to compounds of Formula (I), a search for a composition according to claim 1 (Group I) would inevi-tably also function to search for art pertaining to methods for use of such compositions (Group II).” See applicant’s Remarks at p. 3. This is not true. A search of Group II will require considera-tion of references relating to PLpro, not just the references that relate to compounds within the scope of the claims. The requirement is still deemed proper and is therefore made FINAL. Claims 18-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction requirement in the reply filed on June 11, 2026.
Objection to The Specification
The chemical structure of NEU-7792 appears to be missing a -CH₂- group (next to the -CF2- group). Compare the chemical structure in applicant’s specification (see, e.g., pp. 69-70) with instant claim 15. Or perhaps claim 15 includes an erroneous -CH₂-group. In either case, the description of NEU-7792 in the specification appears to be inconsistent with the subject matter of claims 12-16. Appropriate correction or clarification is required.
Claim Rejections – 35 U.S.C. 112
The following is a quotation of 35 U.S.C. 112(b) and 112(d):
(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.
(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.
Claims 1-17 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particu-larly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention. The substituents on the R¹ group are unclear. Dependent claim 7 provides for “a five-membered or six-membered heteroaromatic ring or fused ring system containing at least one ring nitrogen atom” as a substituent on R¹ when it is a phenyl group. Dependent claim 8 similarly provides for a thiazole substituent on R¹. Both of these, however, are outside the scope of substituents defined for R¹ in claim 1.
Claims 5-8 are rejected under 35 U.S.C. 112(d) as being of improper dependent form for failing to further limit the subject matter of the claims upon which they depend, or for failing to include all the limitations thereof. As explained in the rejection above, the R⁷ substituents in claims 7-8 are outside the scope of the substituents defined in claim 1. That is, claims 7-8 are impermissibly broader in scope than claim 1. Applicant may cancel the claims, amend the claims to place them in proper dependent form, rewrite them in independent form, or present a suffi-cient showing that they comply with the statutory requirements.
Claim Rejections – 35 U.S.C. 102
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)(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 1-7 and 17 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by WO 2023/223055 A1 by Kirkham et al.
Note that Kirkman qualifies as prior art for the reasons discussed in MPEP1 2154.01(a) (WIPO Published Applications).
See the last compound at p. 88, which has the following chemical structure:
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This compound meets the limitations of at least instant claims 1-4. See also the following compound, which is disclosed in the reference at p. 87:
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This compound meets the limitations of at least instant claims 1-7. The reference also discloses pharmaceutical compositions (para. 00255 et seq.) within the meaning of instant claim 17.
Claim Rejections – 35 U.S.C. 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 explained in MPEP 2141 et seq. They 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.
Claims 1-8 and 12-17 are rejected under 35 U.S.C. 103 as being unpatentable over Kirkham et al. as applied above.
As noted above, Kirkham discloses (p. 87) the following compound:
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Note the portion of the molecule that is circled, above. The reference refers to this substituent as R². Elsewhere (see the first group listed on p. 53), the reference explains that the following is an alternative R² substituent:
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By substituting the R² group circled in the chemical structure above for the corresponding thiazole-containing R² substituents illustrated immediately above, one arrives as subject matter within the scope of instant claim 8. One would have viewed substituting one R² substituent for another equivalent R² substituent in this manner as being a matter of routine experimentation and therefore prima facie obvious. See MPEP 2144.06(II), which explains that “[a]n express suggestion to substitute one equivalent component or process for another is not necessary to render such substitution obvious.” The examiner therefore concludes that the subject matter of at least instant claims 1-8 is prima facie obvious.
With respect to claims 12-16, see the discussion of the portion of the molecule that the reference refers to as L². See, e.g., para. 0044-49. According to the reference (para. 00222), the alkylene portion of L² may be substituted with one or more fluorine atoms, which would have suggested compounds within the meaning of these claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Theodore R. Howell whose telephone number is (571)270-5993. The exam-iner can normally be reached Monday - Thursday, 8:00 am - 7:00 pm (Eastern Time). 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, Amy L. Clark can be reached at (571)272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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THEODORE R. HOWELL
Primary Examiner
Art Unit 1628
/THEODORE R. HOWELL/ Primary Examiner, Art Unit 1628
July 13, 2026
1 Manual of Patent Examining Procedure (MPEP), Latest Revision November 2024 [R-01.2024]
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