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 .
Priority
This application is a 371 of PCT/EP2022/063943 (05/23/2022)
and claims foreign priority to EP 21175419.7 (05/21/2021).
Status
Rejections not reiterated are withdrawn.
Claims 1, 4, 6, 8, 10-12 are pending.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 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.
Claims 1, 4, 6, 8, 10-12 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.
The scope of enablement provided in the disclosure is not commensurate in scope with the claims when considering the factors detailed in MPEP 2164.08:
The courts have 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’” or that any experimentation must be “reasonable”. See Amgen Inc. et al. v. Sanofi et al., 598 U.S. 594, 2023 USPQ2d 602 (2023); McRO, Inc. v. Bandai Namco Games Am. Inc., 959 F.3d 1091, 2020 USPQ2d 10550 (Fed. Cir. 2020); Wyeth & Cordis Corp. v. Abbott Laboratories, 720 F.3d 1380, 107 USPQ2d 1273 (Fed. Cir. 2013); Enzo Life Sciences, Inc. v. Roche Molecular Systems, Inc., 928 F.3d 1340 (Fed. Cir. 2019); and Idenix Pharmaceuticals LLC v. Gilead Sciences Inc., 941 F.3d 1149, 2019 USPQ2d 415844 (Fed. Cir. 2019). See also In re Wright, 999 F.2d 1557, 1561, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993). …
With respect to the breadth of a claim, the relevant concern is whether the scope of enablement provided to one skilled in the art by the disclosure is commensurate with the scope of protection sought by the claims. The Federal Circuit, citing McRO, provided guidance on the application of enablement to genus claims, holding that “[a]lthough a specification does not need to describe how to make and use every possible variant of the claimed invention, when a range is claimed, there must be reasonable enablement of the scope of the range.” Sanofi-Aventisub, 987 F.3d at 1085 (internal quotations omitted). AK Steel Corp. v. Sollac, 344 F.3d 1234, 1244, 68 USPQ2d 1280, 1287 (Fed. Cir. 2003);In reMoore, 439 F.2d 1232, 1236, 169 USPQ 236, 239 (CCPA 1971). See also Plant Genetic Sys., N.V. v. DeKalb Genetics Corp., 315 F.3d 1335, 1339, 65 USPQ2d 1452, 1455 (Fed. Cir. 2003) (alleged “pioneer status” of invention irrelevant to enablement determination).
Claim 1 as amended is to a “method of treating an SLC16A3-associated disease/disorder … comprising administering … a therapeutically effective amount of a compound of formula (I)”. The instant disclosure does not contain sufficient information regarding the subject matter of the claims as to enable one skilled in the pertinent art to make and use the claimed invention upon consideration of the factors set forth in In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1998), as follows. See also MPEP § 2164.01(a) and § 2164.04.
The breadth of the claims – the claims are to a method of treating SLC16A3 (aka MCT4) associated disease/disorders which is a large genus of broadly defined diseases and conditions with innumerable species – see for example Specification 1-5 eluding to cancers, inflammatory disease, neurological disease, etc., and page 38-39 exemplary treatment of disorder or disease.
The nature of the invention – the nature of the claimed invention is SLC16A3 (aka MCT4) inhibitors for use in treating or preventing disease or disorders.
The state of the prior art – the therapeutic approach of SLC16A3 inhibitors for treating or preventing disease is unknown and Applicant cites no known successful demonstrations of the approach (specification p. 1-4).
The level of one of ordinary skill – the level of skill in the art is high as evidenced by Parnell et al. (WO2018111904).
The level of predictability in the art – the art is highly unpredictable due to the complex nature of the disease and the mode of action of the compounds used. The particular art is also unpredictable because there is no known or demonstration of how the compounds produce an inhibitory effect that would treat disease. Furthermore, as evidenced by Parnell et al. (WO2018111904, Table 27, p. 210-213, Table 31) small changes in inhibitor structure can cause drastic changes in IC50 assay values of the same target tested in the instant application, SLC16A3 (MCT4), supporting pharmacologic activity. In addition, compounds within the scope of the instant claims including Sharma et al. (J. Med. Chem. 2015, 58, 1563−1568) teaches the following compound 40:
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corresponding for claim 1’s formula (I) when R1 is H; R2 and R3 are CH3; L is CH2CH2C(O)N(H); R4 is aryl (phenyl). Sharma performed a HTS inhibition assay of the compound and found that the compound was inactive in an inhibition assay related to treating diabetes – a disease/disorder within the instant claims.
The amount of direction provided by the inventor – the primary guidance provided is shown in Table 1 wherein a small number of highly similar compounds were tested for activity. The chemical space of the compounds of Table 1 is extremely narrow when compared to the full scope of the claims. In addition, there is no guidance regarding how the alleged use would reasonably correlate with the entire scope of that claim based on the structure of the compounds of those tested – the capability to recognize or understand the structure from the mere recitation of function and minimal structure space is highly unlikely. This lack of supporting data and explanation would cause one of skill in the art to question whether the examples support the enablement of the full scope of the claims beyond those demonstrated to be useful – i.e., Table 1 of the specification.
The existence of working examples – the 19 examples of Table 1 were tested in an in vitro assay. As stated in the specification there are no known selective SLC16A3 inhibitor or any corresponding use as a pharmaceutical.
The quantity of experimentation needed to make or use the invention based on the content of the disclosure – given the high level of unpredictability in the art, the lack of working examples, and the limited guidance provided in the examples, there would be a tremendous amount of experimentation required before one of skill in the art could practice the claimed invention including the utility of treating or preventing disease in a subject.
In view of the specification and evidence of record, one of skill in the art would be required to perform an undue amount of experimentation to test each of the compounds of the claims using an appropriate model and select candidates for further development in vivo, perform testing to determine dosing, and finally efficacy testing, including to determine what would be a therapeutically effective amount for each of the innumerable diseases or disorders. Thus, one of skill in the art would be required to start ab initio and develop any compound within the scope of the claims. Such a level of experimentation is undue. Weighing the above factors by a preponderance of the evidence results in the conclusion that the claims are not enabled for the full scope of SLC16A3-associate disease or disorders.
Conclusion
No claims allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/ROBERT H HAVLIN/Primary Patent Examiner, Art Unit 1626
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