DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions. Claims included in the prosecution are claims 1-21.
Claim Objections
Applicant is advised that should claim 15 be found allowable, claim 21 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Allowable Subject Matter
Claims 1-21 are free of prior art.
The following is a statement of reasons for the indication of allowable subject matter: Claims 1-21 are free of prior art for substantially the same reasons as to why the claims in U.S. Application No. 16/104,101 are allowed.
Double Patenting - Statutory
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 1-6 are rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1-6 of prior U.S. Patent No. 8,987,237. This is a statutory double patenting rejection.
Double Patenting – Non-Statutory
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 1-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,793,819, claims 1-14 of U.S. Patent No. 8,987,238, claims 1-12 of U.S. Patent No. 9,006,222, claims 1-13 of U.S. Patent No. 9,012,434, claims 1-30 of U.S. Patent No. 11,103,516, claims 1-30 of U.S. Patent No. 11,103,513, and claims 1-30 of U.S. Patent No. 11,110,099. Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims recite a more specific version of the instant claims (i.e., the conflicting claims recite wherein the progesterone is micronized and partially solubilized or specific amounts of the components) and thus read on the instant claims.
Claims 1-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent Nos. 8,633,178, 8,846,648, 8,846,649, 8,933,059, 8,993,548, 9,114,145, 9,114,146, 9,301,920, 9,248,136, 10,206,932, 10,806,740, 11,166,963, and 11,529,360, in view of Lacy et al (U.S. Patent No. 6,096,338 issued on 08/01/2000) and Chen et al (U.S. Patent Application Pub. No. 2003/0077297 published on 04/24/2003).
The pending claims differ from the conflicting claims insofar as reciting a method of treating a menopause symptom or reciting a specific solubilizing agent. However, the claimed method and oil would have been obvious since Lacy et al. teach pharmaceutical compositions comprising a carrier system (i.e., a solubilizing agent) in which a hydrophobic drug is dissolved therein (col 4, lines 21-30 and claims 9, 15, 16, 20, and 21) wherein, in an exemplary embodiment, the dissolved hydrophobic drug is a combination of progesterone and estradiol (claim 14) and a method of treating a menopause symptom in a woman comprising administering an effective amount of the composition (Example 5 at cols 21-22). Chen et al teach a pharmaceutical formulation and method of treatment comprising administering an effective amount of the pharmaceutical composition to a subject in need thereof (para [0015]) wherein the pharmaceutical composition comprises one or more active agents that are fully solubilized, partially solubilized, or suspended in a vehicle (i.e., a solvent system) (Abstract) wherein the solvent system preferably comprises a triglyceride surfactant, including saturated polyglycolized glycerides such as Gelucire® 44/14 (i.e., lauroyl macrogol-32 glyceride or saturated polyglycolized glycerides) (para [0189], [0192], [0193], [0322], and Example 7 at para [0340]) as well as mono- and diglyceride surfactants such as Capmul® MCM (i.e., glyceryl caprylate/caprate) (para [0147] and Example 52 at para [0371]) and wherein the combination of progesterone and estradiol in the method is used for hormone replacement therapy (para [0051]). Accordingly, the claimed method would have been obvious since progesterone and estradiol are known to treat a menopause symptom as taught by Lacy et al. and the claimed solubilizing agent would have been obvious since it is taught by Chen et al.
Claims 1-21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 37 of copending Application No. 16/244,020 and claims1-24 of copending Application No. 18/053,120 in view of Lacy et al (U.S. Patent No. 6,096,338 issued on 08/01/2000) and Chen et al (U.S. Patent Application Pub. No. 2003/0077297 published on 04/24/2003).
The pending claims differ from the conflicting claims insofar as reciting a method of treating a menopause symptom or reciting a specific solubilizing agent. However, the claimed method and oil would have been obvious since Lacy et al. teach pharmaceutical compositions comprising a carrier system (i.e., a solubilizing agent) in which a hydrophobic drug is dissolved therein (col 4, lines 21-30 and claims 9, 15, 16, 20, and 21) wherein, in an exemplary embodiment, the dissolved hydrophobic drug is a combination of progesterone and estradiol (claim 14) and a method of treating a menopause symptom in a woman comprising administering an effective amount of the composition (Example 5 at cols 21-22). Chen et al teach a pharmaceutical formulation and method of treatment comprising administering an effective amount of the pharmaceutical composition to a subject in need thereof (para [0015]) wherein the pharmaceutical composition comprises one or more active agents that are fully solubilized, partially solubilized, or suspended in a vehicle (i.e., a solvent system) (Abstract) wherein the solvent system preferably comprises a triglyceride surfactant, including saturated polyglycolized glycerides such as Gelucire® 44/14 (i.e., lauroyl macrogol-32 glyceride or saturated polyglycolized glycerides) (para [0189], [0192], [0193], [0322], and Example 7 at para [0340]) as well as mono- and diglyceride surfactants such as Capmul® MCM (i.e., glyceryl caprylate/caprate) (para [0147] and Example 52 at para [0371]) and wherein the combination of progesterone and estradiol in the method is used for hormone replacement therapy (para [0051]). Accordingly, the claimed method would have been obvious since progesterone and estradiol are known to treat a menopause symptom as taught by Lacy et al. and the claimed solubilizing agent would have been obvious since it is taught by Chen et al.
This is a provisional nonstatutory double patenting rejection.
Conclusion
Claims 1-21 are rejected.
No claims are allowed.
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/TRACY LIU/Primary Examiner, Art Unit 1612