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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Current Status of 18/132,120
This Office Action is responsive to the amended claims of 14 January 2026.
Claims 1-15 have been examined on the merits. Claims 1-12 and 14-15 are original. Claim 13 is currently amended.
Priority
The effective filing date is 12 October 2022.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 3 December 2025, was filed after the mailing date of the Non Final Office Action on 1 December 2025. The submission 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
The Examiner acknowledges receipt of and has reviewed Applicants’ claim amendments and Reply of 14 January 2026.
Applicants’ revisions to claim 14 rendered moot the 35 USC 112b and 35 USC 112d rejections (of paragraphs 8-13 made in the previous Office Action).
Examiner notes Applicants’ request to hold in abeyance the provisional non-statutory double patent rejection against co-pending 19/364,877 (of paragraph 17 in the previous Office Action).
Rejections cannot be held in abeyance.
Furthermore, the co-pending reference 19/364,877 is the earlier-filed application since it is based on a reissue. “The patent term filing date of a reissue application for purposes of nonstatutory double patenting analysis is the patent term filing date of the original application that resulted in the patent for which reissue is sought.” See MPEP 804(I)(B)(1)(a).
The non-statutory double patent rejection against co-pending reference 19/364,877 is maintained, and reproduced, below. This Office Action is therefore properly made FINAL.
Terminal Disclaimer (TD)
On 14 January 2026, Applicants filed a TD against U.S. Patent: 11,655,240 B1; and against co-pending US patent applications: 18/126,157; and 90/019,368, thereby rendering moot the non-statutory double patent rejections (made within paragraphs 14-16 and 18 of the previous Office Action). This TD was also approved on 14 January 2026.
Double Patenting – Maintained Rejection
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 1-15 are provisionally rejected on the ground of anticipatory nonstatutory double patenting as being unpatentable over claims 7-20 and 21-27 of co-pending Application No. 19/364,877 (reference application). The reference amended claims of 21 October 2025 and the instant claims of 14 January 2026 were used to write this rejection.
Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims anticipate the instant claims. Reference claims 7 and 10, drawn to a crystal form comprising a compound of formula I and fumaric acid, wherein the crystalline (polymorph) form thereof comprises at least three XRPD peaks selected from the group consisting of: 10.94* + 0.2* 2Ɵ, 19.06* + 0.2* 2Ɵ, 23.50* + 0.2* 2Ɵ, and 24.66* + 0.2*2Ɵ and various particle size requirements anticipate instant claims 1 and 8, drawn to same.
Furthermore, the molar ratio of reference claim 21 anticipates that of instant claim 7.
The 15% to 60% by weight requirements of reference claim 11 anticipate those of instant claim 9.
Reference claim 12, drawn to various fillers, disintegrants, lubricants, binders, and glidants, anticipates instant claim 10, drawn to same.
The composition constituents of reference claim 13 anticipates instant claim 11, drawn to same.
The weight percentages of reference claim 14 anticipate instant claim 12, drawn to same.
The method of reference claim 20 anticipates instant claims 13-14, drawn to same.
Reference col. 4 describes the “subject” as a human, thereby anticipating instant claim 15. This last part was added due to Applicants’ amendments to parent claim 13.
Filing a Terminal Disclaimer (TD) will render moot this rejection.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
This rejection is properly made FINAL because it is being maintained and/or due to Applicants’ amendments to claim 13.
Conclusion
No claims are presently allowable as written.
Claim 1 is free of the prior art for the rationale stated within paragraphs 20-24 of the Non-Final Office Action mailed 1 December 2025.
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 JOHN S KENYON whose telephone number is (571)270-1567. The examiner can normally be reached Monday-Friday 10a-6p.
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 D 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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/JOHN S KENYON/Primary Patent Examiner, Art Unit 1625