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 .
Information Disclosure Statement
Two information disclosure statement (IDS) submitted: one on 10/23/2024 and one on 08/06/2025. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Drawings
Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
Status of the Claims
Claims 1-8, 10, and 12-22 are pending in this application. Claims 9 and 11 have been cancelled by Applicant.
Examiner Notes
Claims 1-8, 10, and 12-22 are free of the prior art but stand rejected over formal matters and/ or a provisional non-statutory double patenting rejection.
Claim Rejections - 35 USC § 112
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.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], 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.
Claims 2-8, 10, 16, and 17 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, 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.
Claims 2-8, 10, 16, and 17 are rejected for failing to further limit claim 1 from which they depend. Claim 1 is drawn to the crystal form A of the compound of Formula I, and claims 2-8, 10, 16, and 17 are also drawn to the same crystal form of the same compound. Once the crystal form is defined as “Form A” in claim 1, the addition of more peaks of the XRPD or other characterization data for this “Form A” is not further limiting, since the claims are still drawn to the same crystal “Form A” of the same compound of Formula I.
Examiner suggests not defining the crystal Form as “Form A” until later claims. Thus, claim 1 would read: “A crystal form of the compound of Formula I, characterized by x-ray powder diffraction (XRPD) with characteristic peaks at . . . “
Claim 2 would then read: “The crystal form according to claim 1, further characterized by XRPD peaks at . . . “
Then, claim 4 could read: “The crystal form according to claim 3, further characterized by XRPD peaks at (. . .), wherein the crystal form is Form A.“ Or something to that effect.
Amend as indicated in the examples above for all claims with this issue.
Applicant is advised, if as an amendment Applicant removes “Form A” from claim 1, this will result in antecedent basis issues for claims 12-15 and 18-22 – For the purposes of compact prosecution, amend these claims as appropriate.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 13-15, 20, and 22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 23-42 of copending Application No. 18/278,715 (Co. ‘715) – Notice of Allowance Mailed 06/30/2026. Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding claims 13-15, 20, and 22, Co. ‘715 claims the compounds of Formula I, including the instant compound below, pharmaceutical compositions thereof, and methods of treating cardiac conditions comprising administration of their compounds (Co. ‘715’s claims 23, 36, and 38-42) – thus anticipating the instant claims when the instant pharmaceutical compositions and methods of treatment comprise the compound of Formula I and not crystal form A.
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This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-8, 10, and 12-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 23-42 of copending Application No. 18/278,715 (Co. ‘715) – Notice of Allowance Mailed 06/30/2026.
Regarding instant claims 1-8, 10, and 12-22, Co. ‘715 claims the compound of Formula I, pharmaceutical compositions thereof, and methods of treating cardiac conditions comprising administration of their compounds (Co. ‘715’s claims 23, 36, and 38-42)
While Co. ‘715 does not claim the instant crystal form A of Formula I and does not disclose the XRPD peaks instantly recited, they disclose isolation of the instant compound as a solid after filtration from methanol – see [0216] from their specification. The art contains no evidence of any polymorphic diversity for this compound and no alternative crystal forms have been reported. In the absence of such diversity, the XRPD and characterization data of the instant crystal form represent the result of routine recrystallization and characterization of Co. ‘715’s compound. Applicant is advised, isolation and solid-state characterization of compounds are routine steps, particularly in pharmaceutical and fine chemical contexts. If the compound crystallizes under standard conditions – and only a single XRPD pattern is observed – reporting this XRPD profile reflects conventional characterization, not inventive activity. The use of XRPD to confirm the crystalline form of a known compound is a standard analytical approach and would have been obvious in the absence of any evidence of unexpected solid-state behavior or properties. MPEP 2112 states: The court stated that "just as the discovery of properties of a known material does not make it novel, the identification and characterization of a prior art material also does not make it novel."
This is a provisional nonstatutory double patenting rejection.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACKSON J HERNANDEZ whose telephone number is (571)272-5382. The examiner can normally be reached Mon - Thurs 7:30 to 5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney L. Klinkel can be reached at (571) 270-5239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JACKSON J HERNANDEZ/Examiner, Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627
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