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 Application
Claims 1, 3, 7, 8, 22-30 are pending.
Election/Restrictions
Applicant's election without traverse of Group III, claims 26-30, directed to a process of treating –sugar absorption, and the species:
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in the reply filed on 11/14/2025 is acknowledged. The election was made without traverse.
The requirement is therefore made FINAL.
Claims 1, 3, 7, 8, 22-25 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Applicant is reminded that upon the cancellation of claims to a non-elected invention, the inventorship must be amended in compliance with 37 CFR 1.48(b) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. Any amendment of inventorship must be accompanied by a request under 37 CFR 1.48(b) and by the fee required under 37 CFR 1.17(i).
Claims 26-30 are under current examination.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 26-28 and 30 are rejected under 35 U.S.C. 112(a), as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. This is because the specification, while being enabling for treating diabetes, diseases caused by elevated blood glucose levels due to sugar absorption, heart failure as disclosed by common inventor of the instant application (Okuma, US 20230321044 A1) and preventing diabetes complications, does not reasonably provide enablement for the treatment and prevention of the claimed scope of every type of disease associated with SGLT1, SGLT2 and DPP4 activity. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims. As a general rule, enablement must be commensurate with the scope of claim language. MPEP 2164.08 states, “The Federal Circuit has repeatedly held that “the specification must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation.” In re Wright, 999 F.2d 1557, 1561, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993)”. The “make and use the full scope of the invention without undue experimentation” language was repeated in 2005 in Warner-Lambert Co. v. Teva Pharmaceuticals USA Inc., 75 USPQ2d 1865, and Scripps Research Institute v. Nemerson, 78 USPQ2d 1019 asserts: “A lack of enablement for the full scope of a claim, however, is a legitimate rejection.” The principle was explicitly affirmed most recently in Liebel-Flarsheim Co. v. Medrad, Inc. 481 F.3d 1371, 82 USPQ2d 1113; Auto. Tech. Int’l, Inc. v. BMW of N. Am., Inc., 501 F.3d 1274, 84 USPQ2d 1108 (Fed. Cir. 2007), Monsanto Co. v. Syngenta Seeds, Inc., 503 F.3d 1352, 84 U.S.P.Q.2d 1705 (Fed. Cir. 2007), and Sitrick v. Dreamworks, LLC, 516 F.3d 993, 85 USPQ2d 1826 (Fed. Cir. 2008).
Pursuant to In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988), one considers the following factors to determine whether undue experimentation is required:
(1) The breadth of the claims
(2) The nature of the invention
(3) The state of the prior art
(4) The level of one of ordinary skill
(5) The level of predictability in the art
(6) The amount of direction provided by the inventor
(7) The existence of working examples
(8) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
Some experimentation is not fatal; the issue is whether the amount of experimentation is “undue”; see In re Vaeck, 20 USPQ2d 1438, 1444.
The analysis is as follows:
(1) The breadth of the claims:
The presently claimed invention is directed to a method of treatment and prevention of every type of disease associated with SGLT1, SGLT2 and DPP4 activity or caused by elevated blood glucose levels comprising administering compound II with at least one of SGLT2 or DPP4 inhibitor. While such “prevention” might theoretically be possible under strictly controlled laboratory or in vitro conditions, as a practical matter it is extremely risky and nearly impossible to achieve in the “real world” in which patients live. Therefore, the scope of the diseases covered is deemed very broad, and cannot be considered enabled by the instant specification.
(2) The nature of the invention:
The present claims describe a method for treatment and prevention of every type of disease associated with SGLT1, SGLT2 and DPP4 activity or caused by elevated blood glucose levels comprising administering compound II with at least one of SGLT2 or DPP4 inhibitor. In order to be enabled to practice the present invention, the skilled artisan would have to accept that by administering the combination that such therapeutic objectives could actually be achieved. However, in light of the fact that the specification fails to provide the skilled artisan with any direction or guidance as to how the treatment of every disease in general associated with SGLT1, SGLT2 and DPP4 activity could be achieved, the present specification is viewed as lacking an enabling disclosure of the entire scope of the claimed invention.
(3) The state of the Prior Art:
SGLT1, SGLT2 and DPP4 inhibitors are known to treat diabetes (WO 2019/144864 A1; WO2011109333; as provided by the applicant on IDS dated 03/03/2023), US 20130085132 A1 and heart failure (Okuma, US 20230321044 A1).
Accordingly, there is substantive “reason for one skilled in the art to question the objective truth of the statement of utility or its scope” (In re Langer, 183 USPQ 288, 297), specifically, the scope of covering cancer generally.
Similarly, In re Novak, 134 USPQ 335, 337-338, says “unless one with ordinary skill in the art would accept those allegations as obviously valid and correct, it is proper for the examiner to ask for evidence which substantiates them.” There is no such evidence in this case. Likewise, In re Cortright, 49 USPQ2d 1464, states: “Moreover, we have not been shown that one of ordinary skill would necessarily conclude from the information expressly disclosed by the written description that the active ingredient” does what the specification surmises that it does. That is exactly the case here. Moreover, even if applicants’ assertion that all diseases associated with SGLT1, SGLT2, and DPP4 activity, in general could be treated with these compounds were plausible, which it is not, that “plausible” would not suffice, as was stated in Rasmusson v. SmithKline Beecham Corp., 75 USPQ2d 1297, 1301: “If mere plausibility were the test for enablement under section 112, applicants could obtain patent rights to “inventions” consisting of little more than respectable guesses as to the likelihood of their success.”
(4) The skill of those in the art:
The skill of those in the art is expected to be high, requiring advanced training in chemistry, medicine, or pharmacology.
(5) The level of predictability in the art:
The invention is directed toward medicine and is therefore physiological in nature. It is well established that “the scope of enablement varies inversely with the degree of unpredictability of the factors involved,” and physiological activity is generally considered to be an unpredictable factor. See In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970).
With this in mind the level of predictability in the art is sufficiently low. The level of unpredictability in the art renders the scope of instant claim to be not enabled.
(6) The amount of direction provided:
While the treatment of diabetes is discussed and conclusory remarks with regards to treating every disease associated with SGLT1, SGLT2 and DPP4 in broad terms is made, the necessary specifics, i.e. dosing, therapeutic index, IC50etc. with respect to any disease besides diabetes, are completely absent. The limited assays do very little to provide this necessary information, and, the guidance provided is very limited.
(7) Working examples:
The examples of the treatment are limited to diabetes. So the experimentation required, based on solely limited assays on diabetes to practice the instant invention would be egregious.
(8) The quantity of experimentation needed:
In order to translate the suggestions in Applicant’s disclosure into an actual therapeutic method, one skilled in the art would have to develop an actual therapeutic method capable of successfully treating patients. Given the fact that, historically, the development of new drugs has been difficult and time consuming, and especially in view of factors 4 and 5, the quantity of experimentation needed is expected to be great. Further, the quantity needed to expand limited assays as a working example provided in the instant specification to a viable treatment for the claimed scope of diseases and their prevention is untenable.
Genentech, 108 F.3d at 1366, sates that, “a patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion.” And “patent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable.”
MPEP 2164.01(a) states, “A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557,1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993).” That conclusion is clearly justified here.
Claim Rejections - 35 USC § 103
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 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.
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 of this title, 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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 26-30 and elected species are rejected under 35 U.S.C. 103 as being unpatentable over Zheng (WO2019144864 A1; as provided by the applicant on IDS dated 03/03/2023), Miura (US 20130085132 B2) in combination.
Determining the scope and contents of the prior art
Zheng teaches treating diabetes in humans using a combination of SGLT1 inhibitor, and at least one of SGLT2 inhibitor, such as dapagliflozin and/or a DPP4 inhibitor, such as sitagliptin (entire publication, especially abstract, pages 53-54 and claims).
Miura teaches a method of treating diabetes using SGLT1 inhibitor of formula:
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(encompass compound of the instant claims, when n1’=1, one of R1=F and other R1=t-butyl alkoxy; R2=perfluoromethyl and R3=methyl) (entire application, especially, abstract, paragraph 0312 and claims).
Ascertaining the differences between the prior art and the claims at issue
Zheng teaches treating diabetes in humans using a combination of SGLT1 inhibitor, and at least one of SGLT2 inhibitor, such as dapagliflozin and/or a DPP4 inhibitor, such as sitagliptin. However, the cited prior art uses SGLT1 inhibitor different from the instant claims.
Miura teaches a method of treating diabetes using SGLT1 inhibitor, which encompasses SGLT1 inhibitor of the instant claims. However, the cited prior art is silent about combination with least one of SGLT2 inhibitor, such as dapagliflozin and/or a DPP4 inhibitor, such as sitagliptin.
Resolving the level of ordinary skill in the pertinent art
With regards to the above difference- Zheng teaches treating diabetes in humans using a combination of SGLT1 inhibitor, and at least one of SGLT2 inhibitor, such as dapagliflozin and/or a DPP4 inhibitor, such as sitagliptin and Miura teaches a method of treating diabetes using SGLT1 inhibitor, which encompasses SGLT1 inhibitor of the instant claims. Thus, based on the guidance provided by the cited prior art, it would have been prima facie obvious to a person of ordinary skill in the art that in the process of treating diabetes, SGLT1 inhibitor of Zheng may be substituted with another SGLT1 inhibitor, such as taught by Miura with a reasonable expectation of success to treat diabetes.
Further, Case law has established that it is prima facie obvious to substitute one known element for another to obtain predictable results. KSR Int'I Co. v. Teleflex, Inc., 550 U.S. 398 (2007).
Based on the above established facts, it appears that the combination of teachings of above cited prior art read applicants’ process.
Therefore, all the claimed elements were known in the prior art and one skilled person in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention.
Considering objective evidence present in the application indicating obviousness or nonobviousness
To establish a prima facie case of obviousness, three basic criteria must be met: (1) the prior art reference must teach or suggest all the claim limitations; (2) there must be some suggestion or motivation, either in the references themselves or in the knowledge generally available to one of ordinary skill in the art, to modify the reference or to combine reference teachings; and (3) there must be a reasonable expectation of success; and (MPEP § 2143).
In this case, Zheng teaches treating diabetes in humans using a combination of SGLT1 inhibitor, and at least one of SGLT2 inhibitor, such as dapagliflozin and/or a DPP4 inhibitor, such as sitagliptin and Miura teaches a method of treating diabetes using SGLT1 inhibitor, which encompasses SGLT1 inhibitor of the instant claims. So, the combination of prior art read applicants claims.
In KSR International Vo. V. Teleflex Inc., 82 USPQ2d (U.S. 2007), the Supreme Court particularly emphasized “the need for caution in granting a patent based on a combination of elements found in the prior art,” (Id. At 1395) and discussed circumstances in which a patent might be determined to be obvious. Importantly, the Supreme Court reaffirmed principles based on its precedent that “[t]he combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” (Id. At 1395). See MPEP 2143 - Examples of Basic Requirements of a Prima Facie Case of Obviousness [R-9].
In this case at least prong (E) “Obvious to try” – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success would apply.
The rationale to support a conclusion that the claim would have been obvious is that “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103.”KSR, 550 U.S. at ___, 82 USPQ2d at 1397. If any of these findings cannot be made, then this rationale cannot be used to support a conclusion that the claim would have been obvious to one of ordinary skill in the art. Further, there is a reasonable expectation of success that the process of treating diabetes, SGLT1 inhibitor of Zheng may be substituted with another SGLT1 inhibitor, such as taught by Miura and can be made by combination of the above cited prior art.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention by taking the advantage of the teaching of the above cited references and to make the instantly claimed process with a reasonable expectation of success.
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 26-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 3-5 and 8-10 of U.S. Patent No. 11,014,910 and over claims 13-15 of U.S. Patent No. 8846746 (US 20130085132 B2, as discussed above) in view of Zheng (WO2019144864 A1; as provided by the applicant on IDS dated 03/03/2023, discussed in greater detail above).
Claims 3-5 and 8-10 of U.S. Patent No. 11,014,910 discloses SGLT1 compound of the instant Claims 26-30 in treating diabetes, and claims 13-15 of U.S. Patent No. 8846746 (US 20130085132 B2, as discussed above) encompasses SGLT1 compound of the instant Claims 26-30 in treating diabetes. Zheng (WO2019144864 A1; as provided by the applicant on IDS dated 03/03/2023, discussed in greater detail above) teaches treating diabetes in humans using a combination of SGLT1 inhibitor, and at least one of SGLT2 inhibitor, such as dapagliflozin and/or a DPP4 inhibitor, such as sitagliptin. Thus, based on the guidance provided by Zheng and patents, it would have been prima facie obvious to a person of ordinary skill in the art that in the process of treating diabetes, SGLT1 inhibitor of Zheng may be substituted with another SGLT1 inhibitor, such as taught by U.S. Patents ‘910 and ‘746 with a reasonable expectation of success to treat diabetes.
Further, Case law has established that it is prima facie obvious to substitute one known element for another to obtain predictable results. KSR Int'I Co. v. Teleflex, Inc., 550 U.S. 398 (2007).
For the reasons set forth above concerning the obviousness of the use of these SGLT1 compounds in combination with SGLT2 and DPP4 inhibitor in the treatment of diabetes, the present claims represent are obvious.
Claims 26, 27 and 30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 12, 19 and 20 of copending Application No. 17796606. Claims 12, 19 and 20 of copending Application No. 17796606 encompass methods of using compounds of the Instant Claim 26, 27 and 30, for treating SGLT1 associated disease, heart failure, comprising using same SGLT1 inhibitor as in the instant claims and comprising (as referred in the specification, pages 6-8) with at least SGLT2 inhibitor.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claim is allowed.
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/PANCHAM BAKSHI/Primary Examiner, Art Unit 1623