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 .
Election/Restrictions
Applicant’s election without traverse of Group I, drawn to a crystalline form of the compound of Formula 1; and a pharmaceutical composition comprising the crystalline form of Formula 1 and a pharmaceutically acceptable excipient; and the crystalline form of claim 2, characterized by having an XRPD pattern comprising peaks at angles 2-theta of 5.9±0.2, 11.5±0.2, 11.7±0.2, 17.9±0.2, and 19.1±0.2 degrees (Form II) as the species of the compound of Formula 1 in the reply filed on January 29, 2026 is acknowledged.
Claims 12-22, 26, 31, 35, and 37 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on January 29, 2026.
The Examiner acknowledged that the previous office action mailed on October 31, 2025 has mistakenly omitted claim 30, drawn to a pharmaceutical composition, from Group I, said claim is included as part of Group I in this office action.
Status of Claims
Acknowledgement is made of the receipt and entry of the amendment to the claims filed on December 14, 2023, wherein claims 1-3 and 12-13 are unchanged; claims 4-11, 14-22, 26, 30-31, 35 and 37 are amended; and claims 23-25, 27-29, 32-34 and 36 are cancelled.
Claims 1-22, 26, 30-31, 35 and 37 are pending. Claims 12-22, 26, 31, 35, and 37 are withdrawn.
Claims 1-11 and 30 are under examination in accordance with the elected invention and species.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 12/14/2024 and 01/29/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Priority
The instant application 18/460,314 filed on September 1, 2023 claims priority to, and the benefits of Foreign Application No. PCT/CN2022/116765 filed on September 2, 2022.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1 and 30 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Instant claim 1 recites “[a] crystalline form of the compound of Formula 1:
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”; and instant claim 30 recites “[a] pharmaceutical composition comprising the crystalline form of claim 1, and a pharmaceutically acceptable excipient”. The specification discloses only two crystalline species of Formula 1, which are Crystalline Form I of the compound of Formula 1 and Crystalline Form II of the compound of Formula 1. The specification does not disclose any other crystalline form species of the compound of Formula 1 as broadly encompassed by the claim(s); and also, does not disclose any other species of pharmaceutical composition comprising other crystalline form species of the compound of Formula 1.
Regarding the requirement for adequate written description of chemical entities, Applicant's attention is directed to the MPEP §2163. In particular, Regents of the University of California v. Eli Lilly & Co., 119 F.3d 1559, 1568 (Fed. Cir. 1997), cert. denied, 523 U.S. 1089, 118 S. Ct. 1548 (1998), holds that an adequate written description requires a precise definition, such as by structure, formula, chemical name, or physical properties, "not a mere wish or plain for obtaining the claimed chemical invention." Eli Lilly, 119 F.3d at 1566. The Federal Circuit has adopted the standard set forth in the Patent and Trademark Office ("PTO") Guidelines for Examination of Patent Applications under the 35 U.S.C. 112.I "Written Description" Requirement ("Guidelines"), 66 Fed. Reg. 1099 (Jan. 5,2001), which state that the written description requirement can be met by "showing that an invention is complete by disclosure of sufficiently detailed, relevant identifying characteristics," including, inter alia, "functional characteristics when coupled with a known or disclosed correlation between function and structure ..." Enzo Biochem, Inc. v. Gen-Probe Inc., 296 F.3d 316, 1324-25 (Fed. Cir. 2002) (quoting Guidelines, 66 Fed. Reg. at 1106 (emphasis added)). Moreover, although Eli Lilly and Enzo were decided within the factual context of DNA sequences, this does not preclude extending the reasoning of those cases to chemical structures in general. Univ. of Rochester v G.D. Searle & Co., 249 Supp. 2d 216, 225 (W.D.N.Y. 2003).
To provide adequate written description and evidence of possession of a claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the claimed genus. The factors to be considered include disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, or any combination thereof. In the present case, the specification only described two crystalline species of Formula 1, specifically a crystalline form I of Formula 1 described in Example 1 with a X-ray powder diffraction pattern in Fig. 1A and a crystalline form II of Formula 1 described in Example 2 with a X-ray powder diffraction pattern in Fig. 2A. In other words, each of these crystalline forms is characterized by a specific X-ray powder diffraction pattern to identify said form. However, the instant claims pertain to the entire scope of “[a] crystalline form of the compound of Formula 1” without any characteristics drawn to the crystalline form, and that is insufficient to identify any specific crystalline form species of the compound of Formula 1.
A complete pattern containing at least four strongest reflections (major peaks) is often required to reveal the crystal's unique fingerprint. Therefore, in order to sufficiently identify a specific crystalline form species of the compound of Formula 1, at least four major peak positions in a X-ray powder diffraction pattern are required to determine arrangements of all atoms within its unit cell, including lattice parameters, crystal system, and space group.
In the absence of characteristics for a claimed genus, while applicant is in possession of a crystalline form I of the compound of Formula 1 described in Example 1 with a X-ray powder diffraction pattern in Fig. 1A, and a crystalline form II of the compound of Formula 1 described in Example 2 with an X-ray powder diffraction pattern as shown in Fig. 2A, it is not apparent that Applicant was actually in possession of each and every species of crystalline form of the compound of Formula 1 without any characteristics based on the limited disclosure provided at the time the application was filed.
Claim Rejections - 35 USC § 102
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.
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(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 and 30 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Morgan et al. (WO 2022/187501 A1; cited in the IDS filed on 12/14/2023).
The applied reference has a common applicant with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Morgan et al. teaches a compound 4, 5-(3,4-difluorobenzyl)-8-((1r,4r)-4-methylcyclohexyl)-6,9-dioxo-2,5,8-triazaspiro[3.5]nonane-2-carbaldehyde, having the structure of:
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is an exemplary compound of Formula (I) (see e.g., p. 25, Table 1, Compound No. 4; claims 1 and 22). Morgan et al. further teaches any formula given herein is intended to refer also to any one of hydrates, solvates, and amorphous and polymorphic forms of such compounds, and mixtures thereof, even if such forms are not listed explicitly (see e.g., [0075]). Morgan et al. further teaches chromatography, recrystallization and other conventional separation procedures may also be used with intermediates or final products where it is desired to obtain a particular isomer of a compound or to otherwise purify a product of a reaction (see e.g., [0134]). Morgan et al. further teaches a pharmaceutical composition, comprising the compound 4, or tautomer thereof, or a pharmaceutically acceptable salt of any of the foregoing, and one or more pharmaceutically acceptable excipients (see e.g., claim 25; [0015]).
In the present case, the fact that Morgan et al. teaches the compound 4 includes polymorphic forms, and a pharmaceutical composition comprising said compound with one or more pharmaceutically acceptable excipient, the claimed invention is being anticipated by Morgan et al. because the polymorphic form of compound 4 would necessarily contain at least the three XRPD pattern peaks of claim 1 absent evidence to the contrary.
Allowable Subject Matter
Claims 2-11 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.
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 and 30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 and 4-5 of U.S. Patent No. 11,919,909 B2.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the reference patent are drawn to a compound 4 having the structure of:
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(see e.g., claim 1-2); and a pharmaceutical composition comprising (i) said compound, or tautomer thereof, or a pharmaceutically acceptable salt thereof, or a pharmaceutically acceptable salt of the tautomer thereof, and (ii) one or more pharmaceutically acceptable excipient.
The reference patent clearly teaches the compound of Formula I include polymorphs and that anticipates the claimed invention.
Claims 1 and 30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,286,437 B2.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the reference patent are drawn to method(s) of administering a compound of formula:
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to a subject in need of treating a disease or condition associated with hypertrophic cardiomyopathy or a heart disease.
The reference patent clearly teaches the claimed compound include polymorphs, and that anticipates the claimed invention.
It would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to arrive at the claimed invention by combining the compound taught in the reference patent with a pharmaceutically acceptable excipient. One would have been motivated to do so, because the claims of the reference patent teaches the compound of said formula (see chemical formula recites above) can be administered to the subject for treating a heart disease. One would have a reasonable expectation of success to arrive at the claimed invention, because one would have reasonably expected that said compound could successfully be combine with a pharmaceutically acceptable excipient to arrive at a pharmaceutical composition useful for the same purpose without any appreciable loss of activity.
Conclusion
No claims are allowed.
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/CHIHYI LEE/Examiner, Art Unit 1628 /JEAN P CORNET/Primary Examiner, Art Unit 1628