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 .
Detailed Action
Claims 1-21 and 23-26 are currently pending.
Election/Restriction
Applicant’s election with traverse of Group 1 (Claims 1-21 and 23, drawn to compounds and compositions thereof) and the elected species Example 13,
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, in the reply filed on 7/06/2026 is acknowledged.
Again, election was made with traverse. Applicant argues that the required restriction/election is improper because Gnedeva, despite an earlier effective filing date, does not constitute prior art under 35 USC 102(a)(2) and submits that both the Gnedeva WIPO application and the instant application were both owned at the time of filing by the same person not later than the effective filing date of the instant invention.
Applicant’s argument is persuasive and the requirement for a group and species election is withdrawn. Further, Gnedeva is disqualified as prior art and not applied in the rejections below. All pending claims are examined on the merits herein.
Claim Objections
Claims 2-21 and 23 are objected to because of the following informalities:
Claims 2-21 and 23 recite “A compound” rather than “The compound” in the claim preamble or, in Claim 23 drawn to composition, “a compound” rather than “the compound” in reference to compounds previously described in a preceding claim.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 1-4, 7-9, 11-21 and 23-26 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 regards as the invention.
Claims 1 and 7-8 stipulate that Q or Q’ may be or are thiazole:
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. However, Q and Q’ are depicted as follows in Claim 1:
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and
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, wherein thiazole formation is impossible because the carbon adjacent to both nitrogen atoms and the sulfur atom would require no less than five bonds whereas carbon is tetravalent (forming four bonds). Applicant depicts Q and Q’ as “thiazole” rings in Claims 7-8 as follows:
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; however, no double bond is present between the ring nitrogen and an adjacent carbon as required of a “thiazole” ring (see above thiazole structure). Applicant uses a known term used to describe a particular ring structure which is not possible in view of the other limitations shown in Claims 1 and 7-8. Therefore, multiple metes and bounds may be interpreted from one understanding thiazole as it is known in the art or one interpreting thiazole, not as known in the art, but as shown in the respective claims. Applicant must make clear which ring structure or structures are intended and acceptable according to the formulae of Claims 1 and 7-8. Claims 2-4, 11-21, and 23-26 are rejected by virtue of dependency. For the purpose of compact prosecution, the formulae are interpreted as drawn rather than according to the attributed ring name.
Similarly, Claim 9 depicts Q or Q’ as follows:
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, but refers to each compound as thiazine or dihydrothiazine. The two names used in the claim are known in the art according to the following structures, respectively:
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(1,3 structure) and
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. The first claimed structure accords with the second named ring, dihydrothiazine. However, no thiazine is depicted in either claimed structure (for lack of a C=N double bond) and neither of the named rings are unsaturated like the second claimed structure, which resembles a tetrahydrothiazine instead. Again, two metes and bounds may be interpreted, either according to the depicted structures in the claim or the named structures as known in the art. For the purpose of compact prosecution, the formulae are interpreted as drawn rather than according to the ascribed ring name.
Closest Prior Art
The closest prior art is disclosed in Kastan (Nat Commun 12, 3100 (2021). May 25, 2021. 1-12; 2/01/2024 IDS).
Kastan teaches “TRULI”,
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, in Panel C of Fig. 3 of Page 4, in which the following definitions of examined formula II apply: Q’ is a “thiazole” (according to the structure as drawn in Claims 7-8); however, R2 is H in both instances or at one instance. Formula II requires that said Q’ ring be a thiazolidine or a 6-7 membered heterocycle or, in the case that Q’ is a “thiazole”, R2 be an alkylamino or a carbon residue of 3-4 carbons which forms a fused ring with Q’. None of the above limitations are satisfied. Kastan teaches the single compound for use in Lats and Yap modulation toward the same ends of hair cell regeneration (Abstract). Kastan also describes the 7-azaindole core by name, possessed only by examined formula II, suggesting its importance to TRULI discovery, activity, and binding on Page 4 and in Fig. 3. Kastan does not teach saturating or expanding the five-membered heterocycle or variation at all. Therefore, one of skill in the art, lacking direction or suggestion by Kastan, would not seek to alter the sole active compound described because no motivation by Kastan is offered and no reasonable expectation of success can be inferred from the single unmodified compound.
Similar considerations are made with respect to compounds of copending applications 19472621, 19629272, and Patent No. 12617785 which are not encompassed within the genus of the examined formulae. As a result, no double patenting rejections are made thereover.
Conclusion
No claim is allowable.
Inquiries
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Richard G. Peckham whose telephone number is (703)756-4621. The examiner can normally be reached 8:30am - 4:30pm EST.
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/RICHARD GRANT PECKHAM/Examiner, Art Unit 1627
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