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 .
Current Status of 18/573,222
This Office Action is responsive to the amended claims and Applicant remarks of 06/23/2026. Claims 1-3,8,11,13-14,19,22,24-25,30,33-34,41-42,44-46 and 50 are pending and have been examined on the merits.
Priority
The instant application is a national stage entry of PCT/US2022/034550, filed 06/22/2022, which claims priority to U.S. Provisional Patent Application No. 63/214,089, filed 06/23/2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 06/23/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Arguments
Rejections Under 35 U.S.C. §112(b)
Applicants have amended claims 3, 8, 14, 19, 25, 30, 34, and 38 to remove the reference to figures in the specification from the claims These amendments render the previous rejection moot. The rejection is withdrawn.
Double Patenting
Applicants allege that instant claims 1-3, 8, 11, 13-14, 19, 22, 24-25, 30, and 33 are drawn to salt forms of compound (I) with specific molar ratios between the compound and succinic, glutaric, and fumaric acid. Applicants further contend that the specification of the '602 patent was improperly used as if it were prior art. These arguments have been fully considered but are not fully persuasive. The Examiner agrees that the claims which recite specific XRPD values of the claimed salts, such as claims 3, 14, 25, and 34, are distinct non-obvious compounds. However, some of the claims broadly claim generic salts of the compounds disclosed in U.S. Patent 11,718,602. A modified Double Patenting rejection is presented below which makes obvious these generic compounds.
Specific solid forms:
Applicants contend that instant claims 34, 38, 41-42, and 44 are directed to specific crystalline and amorphous forms of compound (I) and that claims 1-8 of the '602 patent do not teach or suggest any specific solid forms of these compounds or the specifically claimed crystalline or amorphous forms. These arguments have been fully considered and are found persuasive. Claim 34 recites specific XRPD values for the freebase crystalline Form B of compound (I) which are not specifically disclosed in the ‘602 patent.
Product-by-process claims Response:
Applicants argue that claims 11, 22, 33, 41, and 44 are directed to specific salt, crystalline, or amorphous forms of compound (I) and require the processes of the indicated claims for preparation. These arguments are not persuasive. The indicated claims depend directly or indirectly from claims 1, 34, and 42, which are all product claims. Claims 11, 22, 33, 41, and 44 each claim the compounds of the independent claims based on the processes by which the compounds are obtained. These claims remain directed to the products of claims 1, 34, and 42 and not the methods of making these compounds. These are by definition product-by-process claims that define the compound through the crystallization process used to obtain the compounds. [P]roduct-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) MPEP 2113.I.
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 1-2-2, 11, 13, 22,24, 33, 42, 44-46, and 50 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 11,718,602, found in IDS filed 02/06/2025 in view of Gould (Gould, Philip L. "Salt selection for basic drugs." International journal of pharmaceutics 33.1-3 (1986): 201-217.) and Bastin (Bastin, Richard J., Michael J. Bowker, and Bryan J. Slater. "Salt selection and optimisation procedures for pharmaceutical new chemical entities." Organic Process Research & Development 4.5 (2000): 427-435.). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims are drawn to compounds of formula (I) and pharmaceutically acceptable salts thereof (claim 1). Claim 8 identifies a species of formula (I)
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or a pharmaceutically acceptable salt thereof. Col 10 line 61-Col 11 line 21 define pharmaceutically acceptable salts and expressly disclose succinic acid as an exemplary compound for generating salts (Col 11, line 15). The ‘602 patent claims the compound without limiting the physical form of the compound. The ‘602 patent therefore encompasses the same instantly claimed compound in any form, including, salt, amorphous, and crystalline forms. The characterization data of the instant claims merely define particular solid-state forms of the same compound previously claimed and do not render the claimed subject matter patentably distinct from the ‘602 patent.
The instant claims additionally recited methods of treating cancer in a subject through administering to said subject a pharmaceutically effective amount of the claimed compound. ‘602 discloses the same methods of treatment using the same compound or pharmaceutical compositions comprising the compound (see Col 13, line 58-Col 22, line 9). The claimed treatment methods merely recite administering the previously claimed compound for a therapeutic purpose already disclosed and therefore do not define a patentably distinct invention from the ‘602 patent.
Gould teaches that only a limited number of pharmaceutically acceptable salts are commonly used in commercial pharmaceutical products (Table 1, pg. 202). Thus, the selection of an appropriate salt would have involved choosing from a finite number of known and pharmaceutically acceptable alternatives available to the artisan for preparing a salt of the claimed compounds.
Bastin teaches that preparation and evaluation of pharmaceutically acceptable salt forms is a routine aspect of pharmaceutical development and is undertaken to improve the physiochemical properties of a drug substance (Abstract). Accordingly, the artisan would have been motivated by the teachings of the references discussed above to prepare and evaluate known pharmaceutically acceptable salts of the claimed compounds in order to identify a salt form having desirable pharmaceutical properties.
Claims 11, 22, 33, 41, and 44 are product-by-process claims that define the compound in part by the crystallization process used to obtain it. However, the patentability of a product-by-process claim is based on the product itself rather than the process of preparation. The recited crystallization steps do not render the claimed compound patentably distinct from the previous claimed compound of ‘602.
Conclusion
Claims 1, 2, 11, 13, 22, 24, 33, 42, 44-46, and 50 are rejected.
Claims 3, 8, 14, 19, 25, and 30 are objected to as being dependent upon a rejected base claim.
Claims 34, 38 and 41 are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CONNOR KENNEDY ENGLISH whose telephone number is (571)270-0813. The examiner can normally be reached Monday Friday, 8 a.m. 5 p.m. ET..
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/C.K.E./Examiner, Art Unit 1625 /Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625
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