CTNF 18/670,859 CTNF 91371 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia 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 1 – 19 are pending and rejected. Priority PNG media_image1.png 50 400 media_image1.png Greyscale Information Disclosure Statement The information disclosure statement (IDS) submitted on September 27, 2024, April 2, 2025 and March 2, 2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. Claim Rejections - 35 USC § 112 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 1 – 19 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. Claims 1 and 7 recite the terms “phosphoric acid ester derivative”. See, line 1 of claim 1, and line 2 of claim 7. The structure of the compound of formula (I) in claim 1 do not claim any limitations for phosphoric acid esters in the variables L, A, R 2 – R 3 and R a – R e . The specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The terms “phosphoric acid ester derivative” are relative and it is unclear the extent to which the structure of the compound of formula (I) can be derivatized and still be considered the same compound. Thus, the metes and bounds cannot be ascertained and the limitation renders the claims indefinite. Dependent claims 2 – 19 do not clarify or remedy the deficiencies of the limitation and are also considered indefinite. In order to overcome the rejection, Applicant may amend the limitation as follows: Claim 1, line 1 of the claim: The phrase “A compound which is a phosphoric acid ester derivative of a compound of formula (I)” should read as “A compound which is a phosphoric acid ester derivative of a compound of formula (I)”. Claim 7, lines 1 – 2 of the claim: The phrase “… said compound being a phosphoric acid ester derivative of a compound of formula (I) selected from…” should read as “… said compound being a phosphoric acid ester derivative of a compound of formula (I) selected from…”. 07-36 The following is a quotation of 35 U.S.C. 112(d): (d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. Claim 3 is rejected under 35 U.S.C. 112(d) as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 3 is directed to a compound according to claim 1 or a pharmaceutically acceptable salt thereof, said compound having formula (II): PNG media_image2.png 344 164 media_image2.png Greyscale . However, the independent claim 1 recites the compound having formula (I): PNG media_image3.png 300 160 media_image3.png Greyscale , wherein L is defined as (C 1 -C 6 )alkylene optionally substituted with one or more -OH. Variable L in claim 1 does not encompass the moiety “-L-O-P(=O)(-OH)-” as claimed in claim 3. Thus, claim 3 fails to include all of the limitations of claim 1 upon which it depends. In order to overcome the rejection, Applicant may cancel the claim, rewrite the claim in independent form as follows: “A compound according to claim 1 or a pharmaceutically acceptable salt thereof, said compound having formula (II)” (see, page 71, lines 1-2 of the claim), or present a sufficient showing that the dependent claim complies with the statutory requirements. Double Patenting 08-33 AIA 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. 08-34 AIA Claim s 1 – 2, 4, 6 – 7 and 10 – 19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 1 – 21 of U.S. Patent No. 12,084,442 B2 . Although the claims at issue are not identical, they are not patentably distinct from each other because : Claim 1 in US ‘442 claims a compound represented by Formula (I): PNG media_image4.png 287 158 media_image4.png Greyscale Claim 8 specifically claims the compound (same as 1 st compound in instant claim 7) PNG media_image5.png 76 458 media_image5.png Greyscale Claims 15 – 16 in US ‘442 specifically claim a pharmaceutical composition comprising a compound according to claim 1 or a pharmaceutically acceptable salt thereof, and one or more pharmaceutically carriers. The pharmaceutical composition further comprises at least one additional pharmaceutically active agents as recited in the instant claims 10 – 11. Claims 17 – 21 specifically claim same methods for treating or preventing a disease or disorder, and maintaining a sinus rhythm after cardioversion in a patient with persistent or recent onset of atrial fibrillation or preventing a recurrence in a patient with paroxysmal atrial fibrillation and , the methods comprising administering to a patient in need thereof a therapeutically effective amount of a compound according claim 1 or a pharmaceutical composition comprising said compound. Therefore, the claims in US ‘442 render the instant claims unpatentable for anticipatory-type double patenting. Claims 1 – 2, 4, 6 – 7 and 10 – 19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 22 – 29, 32 – 34 and 36 – 39 of copending Application No. 18/797,142 (U.S. Publication 20250214989 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because: Claim 22 in US ‘142 claims a method for treating or preventing a disease or disorder responsive to the inhibition of the GIRKI/4 receptor comprising administering to a patient in need thereof a therapeutically effective amount of a compound of formula (I), or pharmaceutically acceptable salt thereof: PNG media_image4.png 287 158 media_image4.png Greyscale Claim 29 specifically claims the method, wherein the compound (same as 1 st compound in instant claim 7) is: PNG media_image5.png 76 458 media_image5.png Greyscale Claims 32 – 33 in US ‘142 specifically claim the method according to claim 22, wherein the compound is administered in a pharmaceutical composition comprising a compound according to claim 1 or a pharmaceutically acceptable salt thereof, and one or more pharmaceutically carriers. The pharmaceutical composition further comprises at least one additional pharmaceutically active agents as recited in the instant claims 10 – 11. Claims 17 – 21 specifically claim same methods, wherein the disease or disorder is selected from cardiac arrhythmia, atrial fibrillation, bradyarrhythmia, bradycardia, heart block, sick sinus syndrome, parasympathetic hyperactivation, primary hyperaldosteronism, hypotension, and vasovagal syncope Therefore, the claims in US ‘142 render the instant claims unpatentable for anticipatory-type double patenting. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to Sagar Patel whose telephone number is (571)272-1317. The examiner can normally be reached Monday - Friday: 9am to 5pm EST. 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, Amy L. Clark can be reached at (571) 272-1310. 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. /Sagar Patel/Examiner, Art Unit 1626 /KAMAL A SAEED/Primary Examiner, Art Unit 1626 Application/Control Number: 18/670,859 Page 2 Art Unit: 1626 Application/Control Number: 18/670,859 Page 3 Art Unit: 1626 Application/Control Number: 18/670,859 Page 4 Art Unit: 1626
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