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 .
Status of the Claims
Claims 12, 19, and 20 are pending, presented for examination, and rejected as set forth below.
Claim Interpretation
Applicants claims are directed to the treatment or prevention of chronic heart failure by the administration of an SGLT1 inhibitor of Formula [II], shown below.
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Claims 19 and 20 specify that the method of Claim 12 are practiced on patients suffering from heart failure with either reduced or preserved ejection fractions.
Response to Amendment
Applicants amendments to the claims, now requiring the use of a specific SGLT1 inhibitor of formula II, above, has overcome the rejection of former claims 7, 13, and 14 over Pabel as evidenced by Franco.
This rejection is WITHDRAWN.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 7, 19, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Miura (U.S. PGPub. 2019/0352284) in view of Pabel (Steffen Pabel, et al, Empagliflozin Directly Improves Diastolic Function in Human Heart Failure, 20 Eur. J Heart Fail. 1690 (2018)), and DiFranco (Alessandra Di Franco, et al, Sodium-Dependent Glucose Transporters (SGLT) in Human Ischemic Heart: A New Potential Pharmacologic Target, 243 Intl. J Cardiol. 86 (2017)).
The applied Miura reference has a common applicant with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under each of 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2).
Miura describes the compound of Claim 12 applicants describe as “Formula [II]” as an SGLT1 inhibitor. (Abs.; [0029]). Miura does not, however, describe this compound in a method of treating heart failure, or more specifically patients suffering from heart failure with reduced or preserved ejection fractions.
This, however, is augmented by the teachings of Pabel and DiFranco. Pabel describes the administration of empagliflozin, an inhibitor of each of SGLT2 and SGLT1, which reduced mortality and hospitalization in patients suffering heart failure, and more specifically improved diastolic function in subjects with each of the reduced and preserved ejection fraction of the instant claims. (1692-95). While Pabel questions the impact of SGLT1 inhibition in the cardiac effects observed, despite negligible SGLT2 expression in the myocardium, DiFranco contradicts this suggestion by establishing the connection between SGLT1 upregulation and myocardial ischemia and hypertrophy in diabetic patients, ruling out the SGLT2 inhibitory activity of empagliflozin as the cause of cardiac effects. (Pg.90).
As the art establishes that inhibition of SGLT1 is responsible for improved cardiac effects demonstrated by the dual SGLT2/SGLT1 inhibitor empagliflozin, and the art establishes the present compounds as SGLT1 inhibitors, their use in the treatment of heart failure to improve diastolic function in subjects with each of the reduced and preserved ejection fraction of the instant claims is prima facie obvious. See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945) (indicating that generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02. In addition, applicants will need to establish that either of the exceptions under 35 U.S.C. 102(b)(1)(A) or 35 U.S.C. 102(b)(1)(B) apply to what appears to be a grace period disclosure of the claimed subject matter (as Miura was published within one year of the effective filing date of the instant application).
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 12, 19, and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 and 6-8 of U.S. Patent No. 11,014,910 in view of Pabel and DiFranco, discussed in greater detail above. Claims 1-3 and 6-8 of U.S. Patent No. 11,014,910 encompass compounds of Instant Claim 12, described by the reference patent as SGLT1 inhibitors. Indeed, the ‘910 patent issued from the same 16/289,500 application the Miura PGPub 2019/0352284 represents. For the reasons set forth above concerning the obviousness of the use of these SGLT1 compounds in the treatment of heart failure demonstrating both preserved and reduced ejection fractions, the present claims represent an obvious use of the compositions and compounds of the ‘910 patent claims.
Claims 12, 19, and 20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 7, and 8 of copending Application No. 17/639,552 in view of Pabel and DiFranco, discussed in greater detail above. Claims 1, 3, 7, and 8 of the ‘552 application encompass methods of using compounds of Instant Claim 12, described by the reference application as SGLT1 inhibitors, in the treatment of diabetic complications. Pabel and DiFranco establish the obviousness of the use of these SGLT1 compounds in the treatment of heart failure demonstrating both preserved and reduced ejection fractions secondary to the treatment of diabetes, the present claims represent an obvious use of the compositions and compounds of the ‘552 application claims.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant's arguments filed 9 January 2026 have been fully considered but they are not persuasive.
Applicants assert the Examiner has not articulated why a skilled artisan would have selected the SGLT1 inhibitor taught by Miura as a lead compound, and instead assert this is an example of hindsight reasoning. To be sure, "[a]ny judgment on obviousness is in a sense necessarily a reconstruction based on hindsight reasoning, but so long as it takes into account only knowledge which was within the level of ordinary skill in the art at the time the claimed invention was made and does not include knowledge gleaned only from applicant’s disclosure, such a reconstruction is proper." In re McLaughlin, 443 F.2d 1392, 1395, 170 USPQ 209, 212 (CCPA 1971). Here, Miura establishes that applicants compound of Formula II was, at the time the instant application was filed, known to act as an SGLT1 inhibitor. The art of record, via Pabel and DiFranco, also establishes the skilled artisan was aware that inhibiting SGLT1 would effectively treat chronic heart failure. This prima facie case of obviousness is not one where a skilled artisan would need to modify a prior art compound to arrive at the present invention, but rather a situation where the invention claimed merely represent the predictable use of prior art elements according to their established function, and obvious thereby. KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976)).
The fact that Miura teaches the compound of Formula II as an SGLT1 inhibitor in the context of treating diabetes does absolutely nothing to detract from the fact that Miura teaches the compound of Formula II is an SGLT1 inhibitor. Art is art, not only for what it expressly teaches, but also for what it would reasonably suggest to the skilled artisan, including alternative or non-preferred embodiments. Merck & Co. v. Biocraft Laboratories, 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989). Here, Miura establishes that applicants compound of Formula II was, at the time the instant application was filed, known to act as an SGLT1 inhibitor. The art of record, via Pabel and DiFranco, also establishes the skilled artisan was aware that inhibiting SGLT1 would effectively treat chronic heart failure.
In a similar manner, the fact that neither Pabel nor DiFranco teach the use of the compound of Formula II in the treatment of heart failure is irrelevant to the question of obviousness. Applicants are reminded that it is not possible to establish the non-obviousness of an invention rendered obvious by the combined teachings of multiple prior art references by arguing that each of the references relied upon fails to teach the entirety of the invention which has been claimed; the absence of a single anticipatory reference is implied by both the reliance on the combined teachings of multiple references as well as the fact that the rejection being made is one of obviousness under 35 U.S.C. 103 rather than any of the subsections of 35 U.S.C. 102. MPEP § 2145(IV), see In re Keller, 642 F.2d 413, 426 (C.C.P.A. 1981) (citing Application of Young, 403 F.2d 754, 757 (C.C.P.A. 1968) (indicating that "[O]ne cannot show non-obviousness by attacking references individually where ... the rejections are based on combinations of references").
The fact that empagliflozin is distinct from that of the present compound of Formula II again does nothing to detract from the fact the art establishes that applicants compound of Formula II was, at the time the instant application was filed, known to act as an SGLT1 inhibitor. The art of record, via Pabel and DiFranco, also establishes the skilled artisan was aware that inhibiting SGLT1 would effectively treat chronic heart failure.
Applicants assert there is no reason a skilled artisan would expect to succeed in treating chronic heart failure with the SGLT1 inhibitors of Miura. Applicants are reminded that obviousness does not require absolute predictability. See In re Rinehart, 531 F.2d 1048, 189 USPQ 143 (CCPA 1976) (indicating that evidence showing there was no reasonable expectation of success may support a conclusion of nonobviousness). Applicants offer no evidence to rebut the conclusion the Examiner has drawn from the art of record. Miura establishes that applicants compound of Formula II was known to act as an SGLT1 inhibitor. Pabel and DiFranco establishes the skilled artisan was aware that inhibiting SGLT1 would effectively treat chronic heart failure.
Applicants arguments concerning the double patenting rejections are unpersuasive for the reasons set forth above.
Conclusion
No Claims are allowable.
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 SEAN M BASQUILL whose telephone number is (571)270-5862. The examiner can normally be reached Monday through Thursday, 5:30 AM to 4 PM.
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, Ali Soroush can be reached at (571) 272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SEAN M BASQUILL/Primary Examiner, Art Unit 1614