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 18/020,980
This Office Action is responsive to the Applicant remarks and amended claims of 10/09/2025. Claims 1-17 have been examined on the merits.
Priority
The instant application is a national stage entry of PCT/US2020/047196, filed 08/20/2020, which claims priority to U.S. Provisional Application No. 63/066,105, filed 08/14/2020.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/09/2025 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
Applicant's arguments filed 10/09/2025 have been fully considered but they are not persuasive. Applicants traverse the non-statutory double patenting rejections over co-pending applications 17/431,460, 17/764,329, 17/962,798, and U.S. Patent 11,501,284 alleging that these references fail to disclose sufficient reasons guiding the artisan to the instantly claimed compounds as part of tablet compositions comprising an organic acid. Applicants also contend that the instant application has demonstrated unexpected results alleging an unexpected stabilizing effect imparted by the organic acid in these compositions.
In the previous Office Action, US application 17/962,798 was identified as a copending application. It is clarified that this reference had issued as Patent No. 12,086,788 B2 at the time of the previous action. The double patenting rejection is maintained over the ‘788 patent.
Applicants’ assertion that the cited references do not provide adequate guidance for the artisan to arrive at the presently claimed compounds is not persuasive. Applicants argue that the artisan would be faced with “numerous options” for selecting substituents and could not arrive at the instant compounds without undue experimentation. However, the artisan would review the exemplified species provided within the disclosure when evaluating the scope of the claimed Markush group. Each reference identifies exemplary compounds of the invention that show substantial overlap with the claimed species (‘460 [0035-0261]; ‘329 [0053-0349]; ‘788 [Col 5, line 20 – Col 9, line 35]; ‘284 [Col 5, line 24 – Col 9, line 35]). One example is N-(3-((6-(2-(7,7-dimethyl-1-oxo-1,3,4,6,7,8-hexahydro-2H-cyclopenta[4,5]pyrrolo[1,2-a]pyrazin-2-yl)-3-(hydroxymethyl)pyridin-4-yl)-4-methyl-3-oxo-3,4-dihydropyrazin-2-yl)amino)phenyl)acrylamide, which appears in each of the references’ exemplary lists (‘460 [0044]; ‘329 [0062]; ‘788 [Col 5, lines 22-25]; ‘284 [Col 5, lines 26-29; and Claim 7]). The presence of the same compound across the disclosures confirms that the structural framework of the claims encompasses compounds sharing the same core and permitted substituents as those relied upon in the instant application.
A further indication that the artisan would not be faced with undue experimentation is that each references provide a synthetic route to N-(3-((6-(2-(7,7-dimethyl-1-oxo-1,3,4,6,7,8-hexahydro-2H-cyclopenta[4,5]pyrrolo[1,2-a]pyrazin-2-yl)-3-(hydroxymethyl)pyridin-4-yl)-4-methyl-3-oxo-3,4-dihydropyrazin-2-yl)amino)phenyl)acrylamide ( ‘460 [0398-0402]; ‘329 [0486-0490]; ‘788 [Col 36, line 41 – Col 37, line 57]; ‘284 [Col 36, line 42 – Col 37, line 57]). These synthetic procedures, taken together with the exemplified compounds, provides a clear illustration of how the inventors understood the claimed scope.
Applicants further allege that the references fail to disclose these compounds as part of tablet compositions. The cited references identify numerous administration routes but provide specific detail only for oral delivery. In the section on oral administration, the references list suitable solid oral dosage forms including tablets, capsules, pills, granules, sachets, effervescent powders, and the like. Accordingly, the record reflects that the tablet formulations were already contemplated for administration of the disclosed compounds (see ‘460 [0277]; ‘329 [0365]; ‘788 [Col 12, line 66- Col 13, line 18]; ‘284 [Col 13 lines 6-25]).
Applicants contend that the cited references do not disclose compositions comprising the compound and an organic acid. However, each reference identifies organic acids as acceptable components of the pharmaceutical compositions, including named organic acids such as citrate (see ‘460 [0266-0267, and [0273]; ‘329 [0354-0356], [0361], and [0405]; ‘788 [Col 11, line 48 – Col 12, line 26]; ‘284 [Col 12, lines 4-33]). In view of these teachings, the record reflects that incorporation of an organic acid with the disclosed compounds was already contemplated.
Applicants assert that the presence of an organic acid as part of the compositions provided the unexpected result of increased stability of the compounds of formula (I). However pH modulation of solid dosage forms, such as tablets, is a well-established formulation strategy for improving chemical stability (see Badawy). The artisan would therefore recognize that selecting an appropriate acidic excipient could influence stability of the active compound. In view of this information, the assertion that stability arising from the presence of an organic acid is ”unexpected” is not persuasive.
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 1-12 and 14-17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4 and 6 of copending Application No. 17/431,460 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the cited claims of the instant application and the claims of the copending application are drawn to the same compounds.
Thus, the claims of the instant application do not present a patentably distinct invention from the claims of the reference.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-3 and 13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 and 16 of copending Application No. 17/764,329 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the cited claims of the instant application and the cited claims of the copending application are drawn to the same compounds and methods of using these compounds for the treatment of neoplastic disease, autoimmune disease, and inflammatory disorder.
Thus, the claims of the instant application do not present a patentably distinct invention from the claims of the reference.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1 and 13 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 7 and 25 of U.S. Patent No. 12,086,788 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the cited claims of the instant application and the cited claims of the copending application are drawn to the same compounds and methods of using these compounds for the treatment of neoplastic disease, autoimmune disease, and inflammatory disorder.
Claims 1-4, 14, and 15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-6 of U.S. Patent No. 11,501,284. Although the claims at issue are not identical, they are not patentably distinct from each other because the cited claims of the instant application and the claims of the copending application are drawn to the same compounds.
Thus, the claims of the instant application do not present a patentably distinct invention from the claims of the reference.
Conclusion
Claims 1-17 are rejected.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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