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 .
Claims 1-14 are pending in the instant application. Claims 1-14 are rejected.
Information Disclosure Statement
The information disclosure statement filed on March 20, 2025 has been considered and a signed copy of 1449 is enclosed herewith.
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 1-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-38 of U.S. Patent No. 8,440,822. Although the claims at issue are not identical, they are not patentably distinct from each other for the reasons given below.
The reference claims are drawn to a method of making a compound of Formula (I). Relevant portion from reference claim 1 is provided below:
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wherein K is CH; A is phenyl; B is 6-membered heteroaryl; R¹ is alkyl substituted by R¹²; n is 1; R² and R³ are H; R⁴ and R⁵ are methyl; and R⁶ is -CF₃.
The instant claims differ by reciting a method of making a species falling within the genus taught in the reference claimed method. The product of instantly claimed method of making, i.e., Formula (1) is a species within the reference taught genus as disclosed in col. 305 of the reference. Further, the reactants disclosed in reference claim 1, i.e., compounds of Formula (II) and Formula (III), generically encompass the reactants of instant claims, i.e., Formula (C3) and Formula (B5), respectively. The reference teaches the reaction is performed in the presence of a solvent, see claims 3-5; in the presence of a base, see claims 6-7; etc., which are analogous to the reaction conditions recited in instant claims. The compounds of the reference claims are disclosed to be useful as pharmaceutical agents, see the abstract and disclosure of the reference.
One of ordinary skill on the art in possession of the reference claimed method of making compounds of generic structural Formula (I) by reacting a compound of Formula (II) with a compound of Formula (III), would have been motivated to select any of the species of the reactants (II) and (III) and prepare the corresponding final product. By reacting any of the species of reactants (II) and (III) and preparing the corresponding final product, the skilled artisan would have had the reasonable expectation of obtaining a product having the same use taught for the reference genus. Any differences in process conditions such as solvent, base, etc. will not support patentability of the subject matter encompassed by the prior art unless there is evidence indicating such process conditions are critical. "[W]here the general conditions of claims are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Thus, a prima facie case of obviousness has been established.
Claims 1-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 10,450,297. Although the claims at issue are not identical, they are not patentably distinct from each other for the reasons given below.
The only difference between the method of making a compound of Formula (1), or a pharmaceutically acceptable salt thereof of the instant claims and the method of making a compound of Formula (1) claimed in U.S. Patent No. 10,450,297 is the option of making a pharmaceutically acceptable salt thereof in the instant claims.
Since the compounds of Formula (1) disclosed in the reference are useful in the treatment of abnormal cell growth, such as cancer, in mammals and are used in pharmaceutical compositions containing such compounds (see abstract), it would have been obvious to one of ordinary skill in the art at the time of the invention through routine experimentation to make pharmaceutically acceptable salts of the compounds of Formula (1) in view of the reference. Thus, a prima facie case of obviousness has been established.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KRISTIN ANN VAJDA whose telephone number is (571)270-5232. The examiner can normally be reached Mon-Fri 6:00-4:00.
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/KRISTIN A VAJDA/Primary Examiner, Art Unit 1622
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