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 .
Upon further consideration restriction requirement filed 10/28/2025 is withdrawn.
Claims 1-7, 11-16, 20-25, 29 and 30 are pending and are examined together.
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 1-7, 11-16, 20-25 (compound), 29 and 30 (method) are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 (compound) and 17-20 (method) of U.S. Patent No. 12378241 = US 20220267324 and Thayyil Adv Pharm Bull, 2020, 10(2), 203-212. Although the claims at issue are not identical, they are not patentably distinct from each other because the subject matter of instant base claim 1 (species), falls under the scope of the conflicting claim 1 (genus).
More specifically, US 20220267324 (dependent) claim 15 second compound is the same as the compound of instant base claim 1.
The instant methanesulfonic acid salt falls under the scope of the ‘pharmaceutically acceptable salt’ of the claims of 20220267324. Methanesulfonic acid salt is not specifically exemplified (but contemplated) in 20220267324. Based on the definition of ‘pharmaceutically acceptable salt’ in specification of 20220267324 methane sulfonate falls under the scope of ‘pharmaceutically acceptable salt’.
The teachings of Thayyil is invoked here for the deficiency in the claims of 20220267324 with respect to instant crystal forms (and the corresponding inherent physical parameters of the crystals). According to Thayyil, at page 203, column A second paragraph, making pharmaceutical crystal allows the modifications to be made to an API, which in turn results in the API with altered physicochemical properties without compromising its intended biological properties (more on this below); the physicochemical properties of a drug like melting point, hygroscopicity, solubility, dissolution, and stability are improved for better drug bioavailability, which leads to gain better therapeutic effect of the drug. Likewise, finding the inherent property such as diffraction pattern or melting point (DSC) is routine in the art, as per teaching of Newman X-ray Powder Diffraction in Solid Form Screening and Selection, September 1, 2011.
As to the correlation of method claims, as pointed out above in the teachings of Thayyil, pharmaceutical properties are not compromised by making crystals (or salts), because it is one of commonsense that biological properties (at pH ~7) depend on drug-protein/enzyme interaction at molecular level (and not on whether the free base or which salt form of the molecule comes into contact with FGFR/VEGFR).
The art made of record and not relied upon is considered pertinent to applicant's disclosure.
Feldman, Understanding ‘Evergreening’ : Making Minor Modifications Of Existing Medications To Extend Protections, Health Affairs June 2022 41:6, 801-804
Dwivedi, Evergreening: A deceptive device in patent rights, Technology in Society 32 (2010) 324–330.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NIZAL S CHANDRAKUMAR whose telephone number is (571)272-6202. The examiner can normally be reached M-F 8-5 EST.
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/NIZAL S CHANDRAKUMAR/Primary Examiner, Art Unit 1625