DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Priority
The present Application, filed June 28, 2021, is a continuation of U.S. Patent Application No. 16/876,599 (now U.S. Patent No. 11,046,690), which is a divisional of U.S. Patent Application No. 16/575,161 (now U.S. Patent No. 10,654,850), which claims the benefit of U.S. Provisional Patent Application Nos. 62/780,553 and 62/732,729, filed December 17, 2018 and September 18, 2018, respectively.
Status of the Claims
Claims 1-6, 13, and 16-29 are currently pending and subject to examination herein.
Response to Arguments/Amendment
In Applicant’s remarks of June 27, 2025, Applicant disagrees with the rejections, including provisional rejections, for nonstatutory double patenting. Applicant’s remarks are substantially the same as those presented in Applicant’s previous response of December 2, 2024. Applicant asserts that the nonstatutory double patenting rejections (both nonprovisional and provisional) are inapplicable because the instant claims are directed to methods of treating anxiety, depression, or pain and, according to Applicant’s argument, the claims of the references patents do not recite treatment of anxiety, depression, or pain (e.g. pg. 2 of Applicant’s remarks, last full paragraph).
This argument has been fully considered and, while it is acknowledged that the instant claims are directed to methods of treating anxiety, depression, or pain, and that the claims of the reference patents do not recite treatment of anxiety, depression, or pain, this argument is found substantially unpersuasive.
This argument was addressed in the Non-final Office Action of December 31, 2024 (hereinafter, “the previous Office Action”). Therein, it was noted that the rejections are for nonstatutory (obviousness-type) double patenting and therefore the preambular purpose of the instant claims does not necessarily have to be recited in the claims of the reference applications for double patenting to be found.
Considering specifically the first reference application, Applicant notes that the ’850 patent and the ’850 patent recite compounds and compositions, but do not recite methods of treatment. However, and as noted in the previous Office Action, the Federal Circuit, and its predecessor court, has repeatedly held that a use of a composition can be obvious for nonstatutory double patenting rejections in view of claims directed to the composition itself in a reference patent, particularly where the specification of the reference application discloses the use claimed in the subject application. See, for example, In re Byck, 48 F.2d 665, 666 (CCPA 1931), where the Court stated that
[i]t would shock one’s sense of justice if an inventor could receive a patent upon a composition of matter, setting out at length in the specification the useful purposes of such composition, manufacture and sell it to the public, and then prevent the public from making any beneficial use of such product by securing patents upon each of the uses to which it may be adapted.
In the present case, the claimed uses (treatment of anxiety, depression, and pain) were disclosed in the reference patent and, as such, a finding of nonstatutory double patenting is appropriate.
In Applicant’s remarks of June 27, 2025, Applicant asserts that the specification of a reference patent cannot be used as “prior art,” citing In re Baird, 348 F.2d 974 at 979-80 (C.C.P.A. 1965). However, In re Byck clearly indicates an exception to the general rule of In re Baird, the exception being based on principles of equity, and applicable to situations when the reference patent claims a composition but discloses a method of using the composition, and the application in question claims the method of using the composition, as in the present case. Furthermore, the Federal Circuit has applied this equitable principle more than once. See, for example, Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC, 349 F.3d 1373 (Fed. Cir. 2003), in which the reference patent claimed a compound and disclosed a single utility of that compound as administration to a human in amounts effective for inhibiting ß-lactamase. The later patent claimed nothing more than the earlier patent’s disclosed utility as a method of using the compound. In this situation, comparable to the present situation, the court, citing In re Byck, found that the claims of the later patent and the claims of the earlier patent were not patentably distinct.
Applicant further repeats the point (pg. 3, first full paragraph of Applicant’s remarks) that U.S. Patent Application No. 16/575,161, from which the ’850 patent was issued, was subject to a Restriction Requirement, dividing the claims into composition claims and method of use claims. Applicant again appears to be suggesting that this precludes a finding of nonstatutory nonobviousness in the present application over the ’850 patent, due to the prohibition in 35 U.S.C. § 121. 35 U.S.C. § 121 prohibits a rejection for nonstatutory double patenting only against a divisional application whose filing was necessitated by a Restriction Requirement in the reference application. While the present application is a continuation of U.S. Patent Application No. 16/876,599, which was itself a divisional of the restricted Application No. 16/575,161, the present application is not a divisional application. This is highlighted by the fact that the present application was filed and initially examined with claims directed to both compositions and methods of using them. As such, the prohibition of 35 U.S.C. § 121 against a finding of nonstatutory double patenting is not applicable in the present case.
With respect to the rejections over the ’690 patent, Applicant reiterates that the claims of the ’690 patent do not recite methods of treating anxiety, depression, or pain, and therefore the invention of the present claims is distinct. This argument has been fully considered but is not found persuasive.
Applicant finally cites MPEP § 1490(VI)(D)(2)(a), suggesting that if the nonprovisional nonstatutory double patenting rejections are overcome, the provisional rejections for provisional nonstatutory double patenting should be withdrawn (paragraph spanning the bottom of pg. 4 to the top of pg. 5 of Applicant’s remarks). However, the nonstatutory rejections for double patenting have not been overcome, as discussed above, and this argument is therefore moot.
Double Patenting – Rejections Reiterated
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 1-6, 13, and 16-29 are rejected for non-statutory double patenting over the ’850 patent:
Claims 1-6, 13, and 16-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 10,654,850 to Ledeboer et al. (hereinafter, “the ’850 patent”). Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-4 of the ’850 patent recite compounds of instant formula I, and the ’850 patent discloses the instant methods of use of said compounds.
Instant claim 1 recites a method of treating a disease or condition selected from the group consisting of anxiety, depression, and pain, the method comprising administering a therapeutically effective amount of a compound of structural formula I:
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where X1, X2, R3, R4, R5, R6, Y, and Q are as defined.
Claim 1 of the ’850 patent recites a compound represented by
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.
Notably, this compound of claim 1 of the ’850 patent is compound 100 of the instant application (bottom of pg. 18 of the instant specification, and instant claims 4-6), which is a species of the compounds of instant formula I.
As a first matter, the Federal Circuit has determined that a claimed method of using a compound is obvious, as a matter of nonstatutory double patenting, over a claim in a reference patent or application reciting the compound itself, particularly when the disclosure of the reference patent of application describes that method of use at issue. See, for example, the method of using a compound of formula I, in the instant claims is obvious, as a matter of nonstatutory double patenting, over the recitation in the ’850 patent of a compound of formula I. See, for example, Geneva Pharmaceuticals v. Glaxosmithkline, 349 F.3d 1373 (Fed. Cir. 2003) and Pfizer v. Teva Pharm., 518 F.3d 1353 (Fed. Cir. 2008).
In Geneva, the court found nonstatutory double patenting where the patentee claimed methods of using clavulanic acid for treating antibiotic-resistant bacteria, while the reference patent claimed clavulanic acid and disclosed its use against the same bacteria. In Pfizer, the subject claims recited methods treating inflammation-associated disorders, the methods comprising administering a genus of compounds including celecoxib. The Court found double patenting over a prior patent whose claims recited celecoxib and whose disclosure taught the relevant uses of celecoxib.
Similarly, in the present case, claim 1 of the ’850 patent recites a compound that is used in the method of instant claim 1, and that method of use is disclosed in the ’850 patent (see, for example, col. 3, lines 9-15 of the ’850 patent). Similarly, the ’850 patent discloses methods of treating depression, anxiety, or pain wherein the pain is neuropathic or visceral pain (relating to instant claims 17-19, see col. 3 lines 9-36 of the ’850 patent). As such, the method of claim 1 and its dependent clams 2-6, 13, and 16-29 are rejected for nonstatutory double patenting over claims 1-4 of the ’850 patent
Claims 1-6, 13, and 16-29 are rejected for non-statutory double patenting over the ’690 patent:
Claims 1-6, 13, and 16-19, 20-21, 24-26, and 29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,046,690 to Ledeboer et al. (hereinafter, “the ’690 patent”), in view of the non-patent publication, Regulation of neuropathic pain behavior by amygdaloid TRPC4/C5 channels, Neurosci. Lett., 608, pgs. 12-17 (2015) by Wei et al. (hereinafter, “Wei”). Claims 17-18, 22-23, and 27-28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of the ’690 patent, in view of the non-patent publication, Acute Treatment with a Novel TRPC4/C5 Channel Inhibitor Produces Antidepressant and Anxiolytic-Like Effects in Mice, PLoS ONE, 10, article no. e0136255 (2015) by Yang et al. (hereinafter, “Yang”). Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-20 of the ’690 patent recite methods of use of the compounds of instant claim 1, involving the same method step of administering the compounds to subject.
The ’690 patent claims methods of treating various kidney diseases, the method comprising administering to a subject in need thereof a therapeutically effective amount of a compound of structural formula I, which is the same as formula I of instant claim 1. The claims of the ’690 patent thus differ from the instant claims in the preambular recitation of purpose – treating kidney disease vs treating pain, depression, or anxiety – while the recited method step is the same.
The case law cited above deals with nonstatutory double patenting of a method of use of a composition over reference claims reciting the composition itself where the reference patent discloses the use. This case law does not explicitly deal with nonstatutory double patenting of a method of use of a composition where the reference claims recite a highly similar method of use of the composition, differing primarily in the preambular purpose of the method, where the reference patent discloses the purpose of the subject claims. The rationale of Byck etc. is applicable to the present situation, however. As such, the method of instant claim 1 and its dependent claims are subject to nonstatutory double patenting rejections over the claimed methods of the ’690 patent, particularly since the ’690 patent explicitly discloses the uses of the instant claims (see, e.g. col. 3, lines 9-36).
Notwithstanding this, the difference between the presently recited methods and the methods claimed in the ’690 patent (administering the claimed compounds for the purpose of treating pain, depression, or anxiety, as opposed to administering the claimed compounds for the purpose of treating kidney disease) was well-known in the art.
Wei, for example, teaches that treatment with a TRPC4/5 antagonist caused a dose-related antihypersensitivity effect and reduced affective-like pain behavior in rats (Abstract). As such, and with respect to claims 1-6, 13, and 16-19, 20-21, 24-26, and 29, it would have been obvious, in view of the teachings of Wei, to adapt the claimed methods of the ’690 patent, which involve administering TRPC4/5 inhibitors, for the treatment of pain.
Similarly, Yang teaches that a TRPC4/5 inhibitor exhibits antidepressant and anxiolytic-like effects in mice (Abstract). As such, and with respect to instant claims 17-18, 22-23, and 27-28, it would have been obvious to one of ordinary skill in the art, to adapt the claimed methods of the ’690 patent for the treatment of depression or anxiety.
Provisional Rejections for non-statutory double patenting:
Claims 1-6, 13, and 16-29 are provisionally rejected for non-statutory double patenting over the ’492 application:
Claims 1-6, 13, and 16-19, 20-21, 24-26, and 29 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2-6 of U.S. Patent Application No. 17/766,492 to Reilly et al. (hereinafter, “the ’492 application”), in view of the non-patent publication, Regulation of neuropathic pain behavior by amygdaloid TRPC4/C5 channels, Neurosci. Lett., 608, pgs. 12-17 (2015) by Wei et al. (hereinafter, “Wei”). Claims 17-18, 22-23, and 27-28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2-6 of the ’492 application in view of the non-patent publication, Acute Treatment with a Novel TRPC4/C5 Channel Inhibitor Produces Antidepressant and Anxiolytic-Like Effects in Mice, PLoS ONE, 10, article no. e0136255 (2015) by Yang et al. (hereinafter, “Yang”). Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-20 of the ’492 application recite methods of use of the compounds of instant claim 1, involving the same method step of administering the compounds to subject.
Claims 2-6 of the ’492 application claims methods of treating various kidney diseases, the method comprising administering to a subject in need thereof a therapeutically effective amount of a compound of structural formula I, which is the same as formula I of instant claim 1. The claims of the ’492 application thus differ from the instant claims in the preambular recitation of purpose – treating kidney disease vs treating pain, depression, or anxiety – while the recited method step is the same. This rejection applies the same reasoning as described above with respect to the ’690 patent.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-6, 13, and 16-29 are provisionally rejected for non-statutory double patenting over the ’299 application:
Claims 1-6, 13, and 16-19, 20-21, 24-26, and 29 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11of U.S. Patent Application No. 17/603,299 to Corson et al. (hereinafter, “the ’299 application”). Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-11 of the ’299 application recite compounds of instant formula I, and the ’299 application discloses the instant methods of use of said compounds.
Claims 1-11 of the ’299 application recite compositions comprising a solvent, a polymer, and a species of instant formula I (specifically, compound 100 of the instant application). The instant claims are therefore subject to rejection for nonstatutory double patenting over claims 1-16 of the ’299 application for the same reasons addressed above in relation to the ’850 patent.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-6, 13, and 16-29 are provisionally rejected for non-statutory double patenting over the ’249 application:
Claims 1-6, 13, and 16-19, 20-21, 24-26, and 29 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent Application No. 17/603,249 to Xue et al. (hereinafter, “the ’249 application”). Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-21 of the ’249 application recite compounds of instant formula I, and the ’249 application discloses the instant methods of use of said compounds.
Claims 1-21 of the ’249 application recite various crystal forms of a species of instant formula (specifically, compound 100 of the instant application). The instant claims are therefore subject to rejection for nonstatutory double patenting over claims 1-16 of the ’249 application for the same reasons addressed above in relation to the ’850 patent.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-6, 13, and 16-29 are provisionally rejected for non-statutory double patenting over the ’928 application:
Claims 1-6, 13, and 16-19, 20-21, 24-26, and 29 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of U.S. Patent Application No. 17/440,928 to Reilly et al. (hereinafter, “the ’928 application”), in view of the non-patent publication, Regulation of neuropathic pain behavior by amygdaloid TRPC4/C5 channels, Neurosci. Lett., 608, pgs. 12-17 (2015) by Wei et al. (hereinafter, “Wei”). Claims 17-18, 22-23, and 27-28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of the ’928 application, in view of the non-patent publication, Acute Treatment with a Novel TRPC4/C5 Channel Inhibitor Produces Antidepressant and Anxiolytic-Like Effects in Mice, PLoS ONE, 10, article no. e0136255 (2015) by Yang et al. (hereinafter, “Yang”). Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-26 of the ’928 application recite methods of use of the compounds of instant claim 1, involving the same method step of administering the compounds to subject.
The ’928 application claims methods of treating various kidney diseases, the method comprising administering to a subject in need thereof a therapeutically effective amount of a compound of structural formula I, which is the same as formula I of instant claim 1. The claims of the ’928 application thus differ from the instant claims in the preambular recitation of purpose – treating kidney disease vs treating pain, depression, or anxiety – while the recited method step is the same, and are subject to provisional rejection for nonstatutory double patenting for the reasons described above in relation to the ’690 patent.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/ALEXANDER K. SHOWALTER/Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629