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 .
Status of Claims
Claims 32-38 are pending in the application as of the second preliminary amendment submitted 11/04/2024. Claims 32-38 are examined herein.
Priority
This application is a 371 of PCT/US2022/032253 filed 06/03/2022, PCT/US2022/032253 claims priority to PRO 63/285,197 filed 12/02/2021,PRO 63/285,201 filed 12/02/2021, PRO 63/196,933 filed 06/04/2021, PRO 63/196,937 filed 06/04/2021.
Information Disclosure Statement
The information disclosure statements submitted on 10/02/2025 and 01/28/2025 have been considered. The submissions are in compliance with the provisions of 37 CFR 1.97.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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)(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 32-38 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Durrant et al. (WO 2021/113627 A1, international filing date 04 December 2020, hereinafter Durrant, in the IDS) (Durrant qualifies as 35 U.S.C. 102(a)(2) prior art with common ownership and different inventive entity).
Regarding instant claims 32-34, Durrant teaches substituted tetrahydrofurans as modulators of sodium channels, pharmaceutical compositions thereof, for use in the treatment of various disorders, including pain (Title; Abstract). Durrant teaches the following exemplary compound, compound 7 (Para. [00266], Pg. 54, last row, first compound; Para. [00278]).
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Compound 7 of Durrant anticipates Compound 1 of instant claim 32. Durrant teaches solid forms of the compound 7 (Para. [00306]). Durrant teaches Form A of compound 7 characterized by an XRPD pattern having diffractions at angles (degrees 2 theta ± 0.2) of 7.3, 9.9, 13.9, 15.7, 19.0, 20.1, 20.3, and 25.4, a DSC thermogram having a melting onset of 186 °C with a peak at 187 °C (Paras. [00308]-[00309]), obtainable by crystallization from methanol at 60 °C (Para. [0310]). ]). Durrant teaches Form A of compound 7 characterized by an XRPD pattern having diffractions at angles (degrees 2 theta ± 0.2) of 7.6, 9.2, 12.0, 12.8, 14.1, 15.1, 15.2, 16.2, 16.9, 17.6, 18.4, 18.5, 18.7, 19.3, 20.3, 21.7, 22.0, 22.2, 22.9, 23.6, 24.0, 24.2, 25.2, 26.9, 27.0, 27.4, 28.6, and 28.9, a DSC thermogram having a melting onset of 182 °C with a peak at 183 °C, a unit cell, as determined by single-crystal X-ray analysis, of the following dimensions: a=7.3929(2) Å; b=14.5827(4) Å; c=18.9312(6) Å; α=90°; β=90°; and γ=90° (Para. [00311]; Para. [00315]; Para. [00317], obtainable by dissolving the compound in ethyl acetate and then crystallizing the compound by adding n-heptane as an antisolvent (Para. [00318]). See also Paras. [00319]-[00331]), Claims 40-55. Durrant teaches pharmaceutically acceptable compositions of the invention additionally comprise a pharmaceutically acceptable carrier, adjuvant, or vehicle (Paras. [00371]-[00373]). Therefore, Durrant anticipates the pharmaceutical compositions of instant claims 32-34.
Regarding instant claims 35-37, Durrant teaches a method of treating or lessening the severity in a subject of chronic pain, gut pain, neuropathic pain, musculoskeletal pain, acute pain, inflammatory pain, cancer pain, idiopathic pain, postsurgical pain, bunionectomy pain, herniorrhaphy pain, … comprising administering an effective amount of a compound of the invention, a pharmaceutically acceptable salt thereof or a pharmaceutical composition thereof (Para. [00376]; Paras. [00377]-[003384]; Paras. [00386]-[00391]; Para. [0400]). Therefore, Durrant anticipates the method of instant claims 35-37.
Regarding instant claim 38, Durrant teaches the term “compounds” includes such a collection of molecules in pure form, in a mixture (e.g., solution, suspension, colloid, or pharmaceutical composition, or dosage form) with one or more other substances, or in the form of a hydrate, solvate, or co-crystal (Para. [0055]). Durrant teaches the exemplary compound, Compound 19, having the following structure (Para. [00344]).
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Compound 19 of Durrant anticipates Compound 1a of instant claim 38.
According to MPEP 2131.02(III), “A GENERIC DISCLOSURE WILL ANTICIPATE A CLAIMED SPECIES COVERED BY THAT DISCLOSURE WHEN THE SPECIES CAN BE "AT ONCE ENVISAGED" FROM THE DISCLOSURE”.
A reference disclosure can anticipate a claim when the reference describes the limitations but "'d[oes] not expressly spell out' the limitations as arranged or combined as in the claim, if a person of skill in the art, reading the reference, would ‘at once envisage’ the claimed arrangement or combination." Kennametal, Inc. v. Ingersoll Cutting Tool Co., 780 F.3d 1376, 1381, 114 USPQ2d 1250, 1254 (Fed. Cir. 2015) (quoting In re Petering, 301 F.2d 676, 681(CCPA 1962)). In the instant case, a composition that comprises instant Compound 1 and instant Compound 1a can be clearly envisaged by a person of ordinary skill in the art, given the disclosure of Durrant.
Therefore, Durrant anticipates the composition of instant claim 38.
Applicants may overcome this rejection under 35 U.S.C. 102(a)(2) by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See MPEP 717.02.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 32-38 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 117-118 and 120 of co-pending Application No 18/959,822 in view of Durrant et al. (WO 2021/113627 A1, international filing date 04 December 2020, hereinafter Durrant, in the IDS).
Although the claims at issue are not identical, they are not patentably distinct from each other.
The instant claims are drawn to a pharmaceutical composition comprising Compound 1 in Form A and/or Form B characterized by the XRPD pattern as in instant claim 32, a method of use thereof.
The claims of the co-pending ‘822 application teaches a pharmaceutical composition and a method of treating or lessening the severity in a subject of chronic pain, comprising administering to the subject an effective amount of a compound (instant Compound 1).
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The reference co-pending ‘822 application do not teach Form A or Form B of Compound 1 and a composition as in instant claim 38.
Durrant teaches solid forms of the compound 7 (i.e., instant Compound 1) (Para. [00306]). Durrant teaches Form A of compound 7 characterized by an XRPD pattern having diffractions at angles (degrees 2 theta ± 0.2) of 7.3, 9.9, 13.9, 15.7, 19.0, 20.1, 20.3, and 25.4, a DSC thermogram having a melting onset of 186 °C with a peak at 187 °C (Paras. [00308]-[00309]), obtainable by crystallization from methanol at 60 °C (Para. [0310]). ]). Durrant teaches Form A of compound 7 characterized by an XRPD pattern having diffractions at angles (degrees 2 theta ± 0.2) of 7.6, 9.2, 12.0, 12.8, 14.1, 15.1, 15.2, 16.2, 16.9, 17.6, 18.4, 18.5, 18.7, 19.3, 20.3, 21.7, 22.0, 22.2, 22.9, 23.6, 24.0, 24.2, 25.2, 26.9, 27.0, 27.4, 28.6, and 28.9, a DSC thermogram having a melting onset of 182 °C with a peak at 183 °C, a unit cell, as determined by single-crystal X-ray analysis, of the following dimensions: a=7.3929(2) Å; b=14.5827(4) Å; c=18.9312(6) Å; α=90°; β=90°; and γ=90° (Para. [00311]; Para. [00315]; Para. [00317], obtainable by dissolving the compound in ethyl acetate and then crystallizing the compound by adding n-heptane as an antisolvent (Para. [00318]). See also Paras. [00319]-[00331]), Claims 40-55. Durrant teaches pharmaceutically acceptable compositions of the invention additionally comprise a pharmaceutically acceptable carrier, adjuvant, or vehicle (Paras. [00371]-[00373]). Durrant teaches the term includes such a collection of molecules in pure form, in a mixture (e.g., solution, suspension, colloid, or pharmaceutical composition, or dosage form) with one or more other substances, or in the form of a hydrate, solvate, or co-crystal (Para. [0055]). Durrant teaches the exemplary compound, Compound 19 (i.e., instant Compound 1a), having the following structure (Para. [00344]).
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Therefore, the instant claims drawn to a pharmaceutical composition comprising the crystalline Form A and/or Form B of Compound 1, a composition comprising Compound 1 and Compound 1a, methods of treating or lessening the severity of pain in a subject, are rendered prima facie obvious, in view of Durrant.
Thus, claims 117-118 and 120 of co-pending application 18/959,822 and instant claims 32-38 are not patentably distinct.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 32-38 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6, 8-17 and 20-23 of co-pending Application No 18/972,540 in view of Durrant et al. (WO 2021/113627 A1, international filing date 04 December 2020, hereinafter Durrant, in the IDS).
Although the claims at issue are not identical, they are not patentably distinct from each other.
The instant claims are drawn to a pharmaceutical composition comprising Compound 1 in Form A and/or Form B characterized by the XRPD pattern as in instant claim 32, a method of use thereof.
The claims of the co-pending ‘540 application teaches a pharmaceutical composition and a method of treating chronic/acute pain in a subject, comprising administering to the subject an effective amount of a compound (instant Compound 1).
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The reference co-pending ‘540 application do not teach Form A or Form B of Compound 1 and a composition as in instant claim 38.
Durrant teaches solid forms of the compound 7 (i.e., instant Compound 1) (Para. [00306]). Durrant teaches Form A of compound 7 characterized by an XRPD pattern having diffractions at angles (degrees 2 theta ± 0.2) of 7.3, 9.9, 13.9, 15.7, 19.0, 20.1, 20.3, and 25.4, a DSC thermogram having a melting onset of 186 °C with a peak at 187 °C (Paras. [00308]-[00309]), obtainable by crystallization from methanol at 60 °C (Para. [0310]). ]). Durrant teaches Form A of compound 7 characterized by an XRPD pattern having diffractions at angles (degrees 2 theta ± 0.2) of 7.6, 9.2, 12.0, 12.8, 14.1, 15.1, 15.2, 16.2, 16.9, 17.6, 18.4, 18.5, 18.7, 19.3, 20.3, 21.7, 22.0, 22.2, 22.9, 23.6, 24.0, 24.2, 25.2, 26.9, 27.0, 27.4, 28.6, and 28.9, a DSC thermogram having a melting onset of 182 °C with a peak at 183 °C, a unit cell, as determined by single-crystal X-ray analysis, of the following dimensions: a=7.3929(2) Å; b=14.5827(4) Å; c=18.9312(6) Å; α=90°; β=90°; and γ=90° (Para. [00311]; Para. [00315]; Para. [00317], obtainable by dissolving the compound in ethyl acetate and then crystallizing the compound by adding n-heptane as an antisolvent (Para. [00318]). See also Paras. [00319]-[00331]), Claims 40-55. Durrant teaches pharmaceutically acceptable compositions of the invention additionally comprise a pharmaceutically acceptable carrier, adjuvant, or vehicle (Paras. [00371]-[00373]). Durrant teaches the term includes such a collection of molecules in pure form, in a mixture (e.g., solution, suspension, colloid, or pharmaceutical composition, or dosage form) with one or more other substances, or in the form of a hydrate, solvate, or co-crystal (Para. [0055]). Durrant teaches the exemplary compound, Compound 19 (i.e., instant Compound 1a), having the following structure (Para. [00344]).
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Therefore, the instant claims drawn to a pharmaceutical composition comprising the crystalline Form A and/or Form B of Compound 1, a composition comprising Compound 1 and Compound 1a, methods of treating or lessening the severity of pain in a subject, are rendered prima facie obvious, in view of Durrant.
Thus, claims 1-6, 8-17 and 20-23 of co-pending application 18/972,540 and instant claims 32-38 are not patentably distinct.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 32-38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7-11, 19-21, 35, 37-38, 47 of U.S. Patent No. 11,834,441 B2.
Although the claims at issue are not identical, they are not patentably distinct from each other.
The instant claims are drawn to a pharmaceutical composition comprising Compound 1 in Form A and/or Form B characterized by the XRPD pattern as in instant claim 32, a method of use thereof.
Claims 1, 7-11, 19-21 and 35 of the reference ‘441 patent renders obvious the pharmaceutical composition comprising the solid forms as instantly claimed in claims 32-34 and a composition as in instant claim 38 (the recitation of the transitional phrase “comprising in claim 35 of the reference patent allows for additional components in the composition). Claims 37-38 and 9-11 of the reference ‘441 patent render obvious the method of instant claims 35-37.
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The instant claims 32-38 and claims 1, 7-11, 19-21, 35, 37-38, 47 of the ‘441 patent are therefore not patentably distinct.
This is a nonstatutory double patenting rejection.
Conclusion
Claims 32-38 are rejected.
No claims are allowed.
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/P.S.R./Examiner, Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627