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 of 07/17/2024. Claims 1-3, 8, 11, 13-14, 19, 22, 24-25, 30, 33-34, 38, 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 statements (IDS) submitted on 02/06/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Rejections - 35 USC § 112
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 3, 8, 14, 19, 25, 30, 34, and 38 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 (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Each of the claims identified above recite the phrase “substantially similar to Figure X.” The referenced figures appear in the drawings. The claims rely on the drawings to define the invention. Claims must stand alone and be understandable without reference to the specification or drawings (see MPEP 2173.05(q)).
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 1-3, 8, 11, 13-14, 19, 22, 24-25, 30, 33-34, 38, 41-42, 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. 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.
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 that the process of preparation. The recited crystallization steps do not render the claimed compound patentably distinct from the previous claimed compound of ‘602.
Conclusion
No claims 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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew Kosar can be reached at (571)272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/C.K.E./Examiner, Art Unit 1625 /Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625