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 .
Status of Claims
The amendments to the claims filed June 27, 2023 are acknowledged and entered. Claims 1-6, 8-15, 17-18, 20, 23, 26, 29 are pending.
Priority
This application is a 371 of PCT/EP21/70994, filed July 27, 2021, which claims the benefit of 63/058,229, filed July 29, 2020.
Information Disclosure Statement
Acknowledgement is made of the Information Disclosure Statements filed on May 11, 2023; June 27, 2023; July 29, 2024; February 20, 2025; July 29, 2025; September 17, 2025; and December 2, 2025. All references have been considered except where marked with a strikethrough.
Election/Restriction
Applicant's election with traverse of Group 1 (claims 1-5, 15 and 17-18) and species corresponding to Example 1 in the reply filed on December 2, 2025 is acknowledged. The traversal is on the ground(s) that Schulze cannot negate the special technical feature shared by the pending claims because Schulze is not available as prior art (see remarks: Schulze does not qualify as prior art because it first published (August 13, 2020, corresponding to PCT No. PCT/EP/2020/053020) after the earliest priority date of the present application (July 29, 2020), and is commonly owned. 35 U.S.C. 102(a)(2)(C))
This is not found persuasive because there was no evidence in the record at the time of the restriction requirement to suggest common ownership and therefore the finding of lack of unity at the time was proper. Moreover, because there was no evidence of common ownership, the Examiner had no reason to expand the search beyond Schulze.
Applicant additionally argues Schulze does not correspond to the pending claims. This is a moot point as Schulze is unavailable as prior art. As evidenced by the rejection herein, the claims lack unity of invention because Formula I does not make a contribution over the prior art. The requirement is still deemed proper and is therefore made FINAL.
Claims 6, 8-14, 20, 23, 26 and 29 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on December 2, 2025 .
The guidelines in MPEP § 803.02 provide that upon examination if prior art is found for the elected species, the examination will be limited to the elected species. Relevant portion of MPEP § 803.02 is provided here for convenience:
The elected species was not found in the prior art and the search was expanded to include the full scope of elected Group 1. Unity of invention is also lacking based on the art rejection provided herein.
Specification
The disclosure is objected to because of the following informalities:
The specification describes Figure 1 (see page 4); however, there does not appear to be any Figure 1 (no drawings have been submitted and Figure 1 does not appear elsewhere). Appropriate correction is required.
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any of the errors of which applicant may become aware of in the specification.
Claim Objections
Claims 2-5 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
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.
Claim(s) 1, 15 and 17-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Anderson et al. (WO 2004/058762) (hereinafter “Anderson”).
Anderson teaches a generic group of compounds which embraces applicants’ claimed compounds (See [00013], Formula II; and Table I) for use as pharmaceuticals and compositions for the treatment of diseases including cancer (see Abstract; Claim 25: neoplasia disorders). Anderson teaches wherein the composition comprises a second active ingredient (claim 29, composition comprises at least one inhibitor compound). The claims differ from the reference by reciting specific species and a more limited genus than the reference. However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to select any of the species of the genus taught by the reference, including those instantly claimed, because the skilled chemist would have the reasonable expectation that any of the species of the genus would have similar properties and, thus, the same use as taught for the genus as a whole. One of ordinary skill in the art would have been motivated to select the claimed compounds from the genus in the reference since such compounds would have been suggested by the reference as a whole. It has been held that a prior art disclosed genus of useful compounds is sufficient to render prima facie obvious a species falling within a genus. In re Susi, 440 F.2d 442, 169 USPQ 423, 425 (CCPA 1971), followed by the Federal Circuit in Merck & Co. v. Biocraft Laboratories, 847 F.2d 804, 10 USPQ 2d 1843, 1846 (Fed. Cir. 1989).”
In particular, Anderson teaches compounds 233 and 686 (pages 75 and 126; pictured below for convenience) which corresponds to instant Formula I wherein R1 is hydrogen; L is
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150
114
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wherein R17, R18, R19 and R20 are each hydrogen; R2a, R2b, and R2c are each H; X is unsubstituted ethylene or ethylene substituted with one R3 wherein R3 is halogen; Y is unsubstituted phenyl and A is hydrogen.
Anderson differs from the instant claims in that the instant claims require wherein A is methyl, phenyl or a monocyclic heteroaryl including thienyl (
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109
64
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,
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140
91
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), furanyl (
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99
158
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) and pyridyl (
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173
336
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). However; Anderson also teaches the genus of Formula V (see [00063]; pictured below for convenience) which provides that the position corresponding to A of the instant claims may be a methyl group, a phenyl group or a heteroaryl group including those claimed (see [00063], page 225, lines 20-25, Y’’ is CR43 and CR43 is any R1 component, R1 is defined at page 20, lines 15-20, to include hydrogen, C1 alkyl, aryl and heteroaryl; aryl is defined at page 29, lines 15-20, to include phenyl; heteroaryl is defined at page 30, lines 5-15, to include pyridyl, thienyl, and furyl). Anderson thus teaches wherein hydrogen, phenyl, pyridyl, methyl, thienyl, and furyl are equivalent groups at the position corresponding to A of instant Formula I.
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300
736
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It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the instant claims to modify Anderson into the claimed compounds because Anderson taught that hydrogen, phenyl, pyridyl, methyl, thienyl, and furyl were equivalent groups at the position corresponding to A of instant Formula I.
One would have been motivated as a matter of practicing the invention of Anderson in order to make additional compounds to treat diseases such as cancer.
One would have had a reasonable expectation of success because Anderson taught that hydrogen, phenyl, pyridyl, methyl, thienyl, and furyl were equivalent groups at the position corresponding to A of the instant claims. One would have thus reasonably expected that modification of Anderson would result in a compound with the same activity and use as compounds 686 and 233. Moreover, a person of ordinary skill in the art could have been reasonably expected to make the modification of Anderson into Formula I as it would have required no more than exchanging a single group (e.g. H) into a claimed group (e.g. thienyl) which Anderson explicitly taught to be equivalent at the same position of the claims.
Conclusion
No claim is allowed.
The following is a statement of reasons for the indication of allowable subject matter:
Anderson et al. (WO 2004/058762), discussed in the rejection herein, is the closest reference to the instant claim. Anderson does not teach the claimed compounds which additionally require wherein X is methylene. There is no teaching which would have motivated one of ordinary skill in the art before the effective filing date of the invention to perform multiple specific modifications of Anderson into the claimed compounds with any reasonable expectation of success.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KEVIN MARTIN whose telephone number is (571)270-0917. The examiner can normally be reached Monday - Friday 8 am - 5 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Murray can be reached on (571) 272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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January 22, 2026
/K.S.M./Examiner, Art Unit 1624
/SUSANNA MOORE/Primary Examiner, Art Unit 1624
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