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 .
Claim Status
Claims 1-3, 5-7, 10-19, 35-37, 39-41 and 44-50 are pending. Claims 1-3, 5-7, 10-19, 35-37, 39-41 and 44-50 are rejected.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-3, 5-7, 10-15, 17, 19, 35-37, 39-41 and 44-46, 48, and 50 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2016/061527 A1 by Martinez Botella et al.
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
The prior art teaches (title) “compositions and methods for treating CNS disorders” and discloses compounds 1 and 2 of instant claims 1-3, 5-6, 35-36 and 39-40 as well as pharmaceutically acceptable salts thereof (pages 17 and 26):
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Regarding instant claims 7 and 41, the prior art teaches pharmaceutically acceptable salts of the compounds above such as the hydrobromide, citrate, etc. (page 72, paragraph [119]).
Regarding instant claims 1, 11-14, 19, 35, 45 and 50, the prior art teaches administering the compounds above to treat a mood disorder such as major depressive disorder or postnatal depression which can include symptoms of reduced sexual desire (pages 39 and 79). Martinez Botella et al. disclose preventing the disorder wherein prevention embraces preventing reoccurrence of symptoms which would entail maintaining sexual function as required by instant claim 35.
Regarding instant claims 15, 17, 46 and 48, the prior art teaches regimens for administering oral doses of about 20 mg/kg of the disclosed compounds once a day (page 70, paragraph [110]).
Ascertainment of the differences between the prior art and the claims. (See MPEP § 2141.02)
The prior art discloses methods of treating/preventing CNS disorders which embraces treating sexual disfunction or maintaining sexual function by administering instant compounds 1 or 2; however, the Martinez Botella et al. do not administer the compound to a subject.
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2142-2143)
A person of ordinary skill seeking to treat symptoms of mood disorders including major depressive disorder and postnatal depression would be motivated to test regimens for administering the compounds above to improve therapeutic outcomes. Regarding instant claims 14 and 45, Martinez Botella et al. do not specifically teach that major depressive disorder presents with symptoms of sexual disfunction however the phrases “of treating sexual dysfunction” and “maintaining sexual function” are intended uses. MPEP 2111.02(II) states:
If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020)
Therefore, the instant methods of treating sexual disfunction or maintaining sexual function by administering instant compounds 1 or 2 to patients with major depressive disorder are obvious in view of the prior art which teaches administering the compounds to subjects with major depressive disorder.
Claim(s) 16, 18, 47 and 49 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2016/061527 A1 by Martinez Botella et al. as applied to claims 1-3, 5-7, 10-15, 17, 19, 35-37, 39-41 and 44-46, 48, and 50 above, and further in view of WO 2006/131392 A1 by Woodward et al.
Martinez Botella et al. disclose methods of treating/preventing CNS disorders which embraces treating sexual disfunction or maintaining sexual function by administering instant compound 2 but do not teach dosages of about 60 mg.
Woodward et al. teach that instant compound 2, 3α-hydroxy3β-methoxymethyl-21-(1'-imidazolyl)-5α-pregnan-20-one, is useful in treating or preventing mood disorders and disclose a 60 mg dose (pages 1 and 5). The prior art teaches that the pharmacokinetic properties of the compound allow for compositions wherein 3α-hydroxy3β-methoxymethyl-21-(1'-imidazolyl)-5α-pregnan-20-one is provided in a range that “will be beneficial in treating disorders that required sustained therapeutic plasma levels of the drug, such as mood disorders” (page 5).
Martinez Botella et al. teach therapeutic regimens comprising administering the same compound once a day and disclose that the compound can also be administered over an extended period of time such as 3 months (page 69, paragraph [107]). Accordingly, a person of ordinary skill seeking to optimize therapeutic regimes for administering 3α-hydroxy3β-methoxymethyl-21-(1'-imidazolyl)-5α-pregnan-20-one to patients with mood disorders would have been motivated to test additional doses of the compound such as the 60 mg dose of Woodward et al. Regarding the “ about 14 days” limitation of claims 16, 18, 47 and 49, the once a day long-term administration taught by Martinez Botella et al. would embrace the 14 days required by the instant claims.
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.
Claim 1-2, 5, 7, 11-19, 35-36, 39, 41 and 45-50 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 11530237 in view of WO 2016/061527 A1 by Martinez Botella et al. and WO 2006/131392 A1 by Woodward et al.
Claims 1-2 of the patent teach the following compound or a salt thereof which is identical to instant compound 2 (Col. 259-260):
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The compound of the patent and its disclosed utility overlaps with the method of treating a CNS-related disorder comprising administering a compound claimed in the instant application taught by Martinez Botella et al. With respect to the fact that the claims of U.S. Patent No. 11530237 are drawn to compounds and compositions while the instant claims are drawn to methods of treatment, Applicant is directed to Sun Pharmaceutical Industries Ltd. v. Eli Lilly and Co. 95 USPQ2d 1797, Geneva Pharmaceuticals, Inc. v. GlaxoSmithKline PLC, 349 F.3d 1373 [68 USPQ2d 1865] (Fed. Cir. 2003), and Pfizer, Inc. v. Teva Pharmaceuticals USA, Inc., 518 F.3d 1353 [86 USPQ2d 1001] (Fed. Cir. 2008) for analogous situations. Use of the compounds for treating CNS-related disorders such as a mood disorder is disclosed in Col. 3, lines 13-20 of Patent No. 11530237; said treatment serves as the basis of a rationale under 35 USC 103. The teachings of Martinez Botella et al. and Woodward et al. relative to claims 1-2, 5, 7, 11-19, 35-36, 39, 41 and 45-50 are incorporated here by reference. The instant claims are deemed to be obvious variants of the subject matter of the patent for the same reasons as under 35 USC 103.
Claims 1-2, 5, 7, 11-19, 35-36, 39, 41 and 45-50 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 74-105 of copending Application No. 18741425 in view of WO 2016/061527 A1 by Martinez Botella et al. and WO 2006/131392 A1 by Woodward et al.
Copending claim 92 discloses a method of treating a CNS-related disorder by administering the following compound or a salt thereof which is identical to instant compound 2:
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This method is the basis of subject matter rendered obvious relative to
claims 1-2, 5, 7, 11-19, 35-36, 39, 41 and 45-50. The teachings of Martine Botella et al. and Woodward et al. relative to claims 1-2, 5, 7, 11-19, 35-36, 39, 41 and 45-50 are incorporated here by reference. The instant claims are deemed to be obvious variants of the subject matter of the copending claims for the same reasons as under 35 USC 103.
This is a provisional nonstatutory double patenting rejection.
Conclusion
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/A.A.C./Examiner, Art Unit 1626
/MATTHEW P COUGHLIN/Primary Examiner, Art Unit 1626