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). Claim Interpretation Claim 1 is to a “compound …for use in the treatment or prevention of an SLC16A3-associated disease/disorder” . The use of the compound is considered an intended use that does not require particular steps be performed or particular structure. Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. MPEP 2111.04. To satisfy an intended use limitation which is limiting, a prior art structure which is capable of performing the intended use as recited in the preamble meets the claim. See, e.g., In re Schreiber, 128 F.3d 1473, 1477, 44 USPQ2d 1429, 1431 (Fed. Cir. 1997) (anticipation rejection affirmed based on Board’s factual finding that the reference dispenser (a spout disclosed as useful for purposes such as dispensing oil from an oil can) would be capable of dispensing popcorn in the manner set forth in appellant’s claim 1 (a dispensing top for dispensing popcorn in a specified manner)) and cases cited therein. MPEP 2111.02. Thus, those claims to a product including claim 1 and those that recite similar use are interpreted as limited to only the structure of the product recited and not any corresponding use. Claim Rejections - 35 USC § 101 35 U.S.C. 101 reads as follows: Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title. Claim 13 is rejected under 35 U.S.C. 101 because the claimed recitation of a use, without setting forth any steps involved in the process, results in an improper definition of a process, i.e., results in a claim which is not a proper process claim under 35 U.S.C. 101. See for example Ex parte Dunki , 153 USPQ 678 ( Bd.App . 1967) and Clinical Products, Ltd. v. Brenner , 255 F. Supp. 131, 149 USPQ 475 (D.D.C. 1966). Claim Rejections - 35 USC § 112 (b) 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. Claim s 2-7 and 9-13 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention. Claim 13 provides for the use of a compound, but, since the claim does not set forth any steps involved in the method/process, it is unclear what method/process applicant is intending to encompass. A claim is indefinite where it merely recites a use without any active, positive steps delimiting how this use is actually practiced. The “use” claims are such that one of ordinary skill in the art would not understand the scope of the claimed invention (MPEP 2173.05(q)). Claims 2-4 and 6 include the language “preferably” in the claim which renders the claim indefinite. See MPEP 2173.05(d) (“Description of examples or preferences is properly set forth in the specification rather than the claims. If stated in the claims, examples and preferences may lead to confusion over the intended scope of a claim. In those instances where it is not clear whether the claimed narrower range is a limitation, a rejection under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph should be made.”). Thus, the claim and those that depend therefrom are rejected as indefinite – claims 2-7 and 9-13. 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 1-7, 9-13 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 is to a “compound of formula (I) …for use in the treatment or prevention of an SLC16A3-associated disease/disorder” with R1 -3 to a genus of substituents including substituted carbocyclyl and heterocyclyl , and R 4 substituted aryl and heteroaryl . 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 compound of formula (I) which is a large genus of compounds having in excess of b illions of compounds. The nature of the invention – the nature of the claimed invention is SLC16A3 ( aka MCT4) inhibitors for use in treating or preventing disease . 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 ) 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. 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. 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 Formula (I) beyond a genus of compounds predictably expected to show selective SLC16A3 activity based on those shown to have activity . Claim Rejections - 35 USC § 102 The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action: A person shall be entitled to a patent unless – (a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention. (a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention. Claims 1-3, 5-7, 10-12 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by STN (Registry 1061375-61-8, Entered STN 14-Oct-2003, cited by Applicant in IDS 11/17/2023) . STN teaches the compound 1061375-61-8 which has the structure: corresponding for claim 1’s formula (I) when R1 is -SCH3; R2 and R3 are CH3; L is CH2CH2C(O)N(H); R4 is heteroaryl (3-quinolinyl). Claims 1-7, 9 -12 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Sharma et al. ( J. Med. Chem. 2015, 58, 1563−1568 ) . Sharma teaches the following compound 40: 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 in solution corresponding to a pharmaceutical composition. Claims 1-8, 10-12 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by PubChem (CID 17476485, create date: 2007-11-13 ) . Pubchem teaches the following compound: corresponding for claim 1’s formula (I) when R1 is -CF3; R2 and R3 are CH3; L is CH2CH2C(O)N(H); R4 is 4-methylphenyl. Conclusion No claims allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT ROBERT H HAVLIN whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-9066 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT 9am - 6pm . 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, FILLIN "SPE Name?" \* MERGEFORMAT Kortney Klinkel can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT (571) 270-5293 . The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /ROBERT H HAVLIN/ Primary Patent Examiner, Art Unit 1626