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 .
Priority
This application is a continuation of U.S. Application No. 18/417,484, filed January 19, 2024, which is a continuation of U.S. Application No. 16/497,724, filed September 25, 2019, now patent number 11,912,706, issued on February 27, 2024, which is a national stage entry of Application No. PCT/US2018/024898, filed March 28, 2018, which claims priority to U.S. Provisional Patent Application No. 62/477,746, filed March 28, 2017; and U.S. Provisional Patent Application No. 62/491,635, filed April 28, 2017.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/05/2024 was filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 21-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 11,912,706.
Although the claims at issue are not identical, they are not patentably distinct from each other because claims 21-22 are drawn to methods of using the product-by-process of claim 1. The crystal form produced by claim 1 appears to be identical to that of issued claims 1-7 because it is produced by the same process as instantly claimed and has the same PXRD pattern. See Col. 16-17, lines 56-3 which recites the production of crystal Form 1 which reads on that instantly claimed. Accordingly, claims 21-22 are interpreted as methods of using the product of issued claims 1-7.
According to MPEP 804(II)(B)(1), “it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context.” In Sun Pharm. v. Lilly, the Court specifically affirms this kind of use of the specification and states,
A ‘claim to a method of using a composition is not patentably distinct from an earlier claim to the identical composition in a patent disclosing the identical use,’ extends to any and all such uses disclosed in the specification of the earlier patent. Sun Pharm. Indus., Ltd. v. Eli Lilly & Co., 611 F.3d 1381, 1387 (Fed. Cir. 2010).
In this case, the instantly claimed uses are taught by the reference disclosure. See “Methods of Treatment” starting Col. 26; solid tumors and wherein the solid tumor is a bladder tumor, etc. are discussed at Col. 26, lines 45-56. Therefore, when construed according to the specification, claims 1-7 of the issued patent describes a crystal form with the same utility as instant claims 21-22. Accordingly, at least claims 21-22 should be rejected on the ground of nonstatutory double patenting as being obvious over claim 1 of US11912706B2. Furthermore, issued claims 7-8 are drawn to methods of treating cancer and wherein the cancer is of the breast etc. A PHOSITA would at once envision the claimed treatment of solid tumors and wherein the solid tumor is a breast tumor, etc. within the issued genus, thereby anticipating instant claims 21-22.
Allowable Subject Matter
The closest prior art is WO2015172123A1 (see 12/05/2024 IDS Foreign Patent Documents Cite No. 018) which teaches synthesis of Compound 2G at Para. [0304] which is equivalent to Compound (I) of the instant claims. The prior art differs from the instant claims in that the crystal form claimed is not taught by the prior art, and the prior art teaches dissolving the compound in DCM to purify the crude compound 2G instead of using an acetone slurry as instantly claimed. Inherency of the crystal form therefore cannot be argued. Accordingly, claims 13-20 are both novel and nonobvious.
Conclusion
Claims 13-20 are allowed.
Claims 21-22 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JED A KUCHARCZK whose telephone number is (571)270-5206. The examiner can normally be reached Mon-Fri 7:30 to 5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam Milligan can be reached at (571) 270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JED A KUCHARCZK/Examiner, Art Unit 1623
/VALERIE RODRIGUEZ-GARCIA/Primary Examiner, Art Unit 1621
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