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 .
CONTINUING DATA
This application is a 371 of PCT/IB2020/057257 07/31/2020
FOREIGN APPLICATIONS
EP 19305999.5 08/01/2019
This office action is in response to Applicant’s remarks submitted October 15, 2025. Claims 1 and 4-13 are pending.
The following rejections are maintained.
Claim Rejections - 35 USC § 112
Claims 1 and 4-13 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The claims recite preparation of form II of sotagliflozin. The specification notes that form II is described in WO 2010009197/A1 and that WO ‘197 provides an exemplary process for making form II. However, the current specification does not provide any guidance for what characteristics form II has, which raises questions as to whether Applicant possessed the claimed invention. In neither instance of reciting WO ‘197 did the applicant include a statement for “incorporation-by-reference,” and thus, the disclosure of WO ‘197 is not part of the original specification. Form II is not described in the specification.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1 and 4-13 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The claims are drawn to a process for preparing form II of sotagliflozin. In the response dated May 21, 2025, Applicant argued that form II cited by Chen is not the same as form II in the current specification, and compares the XRPD spectra of Chen and DePaul. Thus, it is apparent that “form II” does not have an established consistent prior art definition. The current specification does not define form II or give any XRPD peaks. The current specification refers to WO ‘197 (discussed above), but the specification does not include a statement for “incorporation -by-reference,” so it is not part of the original specification and form II is not described in the specification. The skilled artisan would not know whether form II was prepared by the claimed process or not because form II is not defined.
Response to Arguments
Applicant argues that what is conventional or well known to one of ordinary skill in the art need not be described in detail. This argument is not persuasive because MPEP also states that sufficient information must be provided to show that the inventor had possession of the invention as claimed. The specification states that Form II has been described in WO 2010/009197 and that Form II is pure sotagliflozin. The specification does not, however, describe what Form II actually is. MPEP 2163 states that the claimed invention as a whole may not be adequately described if the claims require an essential feature which is not adequately described in the specification and which is not conventional or known in the art. “Form II” of sotagliflozin is not conventional or known in the art because there is no art-recognized definition of Form II. To the contrary, the examiner applied prior art drawn to “Form II” and applicant argued that it was not the same Form II as the Form II recited in the current claims. This raises the question as to (a) which crystal form is actually being claimed and (b) which form Applicant had possession of.
Applicant argues that the claimed invention does not require an explicit description of form II. This argument is not persuasive because the claims require “isolating crystalline form II of sotagliflozin from the product mixture.” The claims require isolating form II.
Applicant argues that the application tells the reader to look to WO ‘197 for the description of form II. This argument is not persuasive because the specification first implies that form II is the purified form. The specification states “Form II (pure sotagliflozin).” The specification also states that WO ‘197 provides an exemplary process for preparing form II. With the use of “exemplary,” it is not clear which characteristics form II has, which raises the question of which composition Applicant had possession of.
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 and 4 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of copending Application No. 17/631,191 (now 12577269). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘191 application claims a method for preparing form II of sotagliflozin from formula (A), wherein the reaction is carried out in toluene or xylene, with sodium methoxide and methanol, and then crystallizing sotagliflozin from a non-aqueous solvent including toluene or xylene. See claim 1. The method includes aqueous washing and subsequent dehydration of the solvent medium (claim 6). The ‘191 claims differ from the current claims because the ‘191 process is continuous and the current claims are not limited as to whether the process is continuous or not. The ‘191 claims are thus narrower than, and anticipate, the current claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
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 LAYLA D BERRY whose telephone number is (571)272-9572. The examiner can normally be reached 7:00-3:00 CST, M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Scarlett Goon can be reached on 571-270-5241. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LAYLA D BERRY/Primary Examiner, Art Unit 1693
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