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 .
DETAILED ACTION
This is a response to Applicant’s communication filed on March 6, 2025. Application No. 18/782,621, filed July 24, 2024, is a Continuation of U.S. Nonprovisional application No. 18/054,435, filed November 10, 2022, (issued as U.S. Patent No. 12,077,554), which is a Continuation of U.S. Nonprovisional application No. 17/225,836, filed April 8, 2021, (issued as U.S. Patent No. 11,530,231) which is a Continuation of U.S. Nonprovisional application No. 16/703,773, filed December 4, 2019,, (issued as U.S. Patent No. 11,034,710), and claims the benefit of U.S. Provisional application No. 62/775,303, filed December 4, 2018. In a preliminary amendment filed March 6, 2025, Applicant cancelled claim 1 and added new claims 2-11. Claims 2-11 are pending.
Claim Rejections - 35 USC § 102(a)(2)
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 2-11 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Warner et al., US2020/0281949 A1.
First, the subject matter of the presently claimed invention is not entitled to the filing date of December 4, 2018, of U.S. Provisional application No. 62/775,303. The present invention is generally drawn to a method of preparing crystalline Form B having the structure of formula (II) from the structure of formula (V) without limitation to any distinct XRPD data defining crystalline Form B. Notably, the structure of formula (V) is not disclosed in U.S. Provisional application No. 62/775,303. The claims of the present invention are not drawn to the unique polymorph claimed in the related sibling application. It is suggested to amend the claims to incorporate at least three of the unique XRPD peaks which define crystal Form B.
In this case, Warner discloses a method of preparing crystalline Form B of a compound having the structure of Formula (II) by contacting a compound of formula (IV) with di-tert-butylhalophosphonate in an amine base, thereby forming a compound of structure (V), subsequently reacting a the compound of formula (V) with an acid in a solvent to arrive at the compound of structure (II). See Warner et al., US ‘949 publc’n, p. 30, para. [0329], Scheme 1.
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 2-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 20-26 of U.S. Patent No. 11, 034,710. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘710 patent claim the same method claimed by the present invention.
Conclusion
No claims are allowed.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIMOTHY R ROZOF whose telephone number is (571)270-5992. The examiner can normally be reached Monday - Friday, 9:00 a.m. -5:00 p.m..
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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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/TIMOTHY R ROZOF/Primary Examiner, Art Unit 1625
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