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 .
DETAILED ACTION
This is a response to Applicant’s communication filed on July 21, 2025. Application No. 18/850,703, is a 371 of PCT/EP2023/057794, filed March 27, 2023, and claims foreign priority to European Patent application No. EP 22164475.0, filed March 25, 2022. In a preliminary amendment filed July 21, 2025, Applicant cancelled claims 1-26, and added new claims 27-46. Claims 27-46 are pending.
Claim Rejections - 35 USC § 102(a)(1)
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.
Claims 27-46 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gibson et al., US2020/0255405 A1. Gibson discloses a method of treating a disease or condition that is responsive to BK B2 receptor modulation in a subject, comprising orally administering to the subject with a disease or condition responsive to BK B2 receptor modulation an effective amount of a BK B2 receptor antagonist having a chemical structure according to Formula (1), or a stereoisomer, salt or solvate thereof:
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280
258
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wherein R is hydrogen or deuterium;
by means of an extended-release composition that is adapted to release the BK B2 receptor antagonist over a period of at least 10 hours, thereby preventing or treating said condition or disease in said subject. See Gibson et al., US ‘405 publc’n, para. [0056], p. 8-11, for compounds reading on Formula (1); see Id., p. 12, para. [0062] and p. 13, para. [0067] for diseases and/or conditions responsive to BK B2 receptor modulation; see Id., p. 12, para. [0064]; p. 16, para. [0099], as well as p. 75, claim 33 for administration and dosing including extended release compositions (i.e., pharmaceutical delivery device).
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.
Claims 29, 36-39, and 45 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.
Regarding claims 29, 36, and 45, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Furthermore, regarding claims 36-39, a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). Claim 36-39 include broad recitations (dose ranges, plasma concentrations, mean AUC production) and the claim also recites “in particular” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
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 27-46 are rejected under 35 U.S.C. 112, first paragraph, because the specification, while being enabling for treating a disease or condition that is responsive to BK B2 receptor modulation wherein the disease or condition that is responsive to BK B2 receptor modulation is selected from the group comprising a skin disorder; eye disease; ear disease; mouth, throat and respiratory disease; gastrointestinal disease; liver, gallbladder and pancreatic disease; urinary tract and kidney disease; disease of male genital organs and female genital organs; disease of the hormone system; metabolic disease; cardiovascular disease; blood disease; lymphatic disease; disorder of the central nervous system; brain disorder; musculoskeletal system disease; allergy disorder; pain; infectious disease; inflammatory disorder; injury; immunology disorder; cancer; hereditary disease; and edema, the specification does not reasonably provide enablement for treating or preventing any-and-all disease or conditions which may be responsive to BK B2 receptor modulation. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims.
Factors to be considered when determining whether claims in an application for patent are enabling include (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, and (8) the quantity of experimentation needed to make or use the invention based on the content of the disclosure. See MPEP § 2164.08, citing In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988).
The claims are generally drawn to treating, as well as preventing any-and-all conditions and/or disease responsive to BK B2 receptor modulation. However, the specification teaches that the compounds of the present invention are similar to other known BK B2 receptor modulators. (Specification, Description, p. 2-4.) The only data presented is with respect the plasma concentration as it concern the extended release formulation. (See Id., Figs. 1-3.) There is no evidence supporting the prevention of any disease or condition. In addition, the prior art fails to provide compensatory guidance. In this case, there is no correlation between BK B2 receptor modulation and treating any-and-all conditions or diseases responsive to BK B2 modulation. Moreover, there is no correlation between BK B2 modulation and preventing any condition or disease. Accordingly, it would require undue experimentation for the artisan to practice the invention as broadly claimed.
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 27-46 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 52-57 of copending Application No. 18/850,683, (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘683 application are drawn to the same method of treatment encompassed by the claims of the present invention.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 27-46 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 33-43 of copending Application No. 18/850,679, (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘679 application are drawn to the same method of treatment encompassed by the claims of the present invention.
Conclusion
No claims are allowed.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIMOTHY R ROZOF whose telephone number is (571)270-5992. The examiner can normally be reached Monday - Friday, 9:00 a.m. -5:00 p.m..
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew Kosar can be reached at (571) 272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TIMOTHY R ROZOF/Primary Examiner, Art Unit 1625
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