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
The Information Disclosure Statements (IDS) filed on 09 November 2023 have been considered.
Election and Claim Status
An election was made without traverse to prosecute the invention of Group I, Claim(s) 1-8. Claim(s) 9-15 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Claim(s) 1-8 are examined on the merits herein.
Claim Interpretation
Claim interpretation, herein, is based upon MPEP 2111.02(I) pertaining to the effect of the preamble of a claim.
Claim(s) 1-8, citing reference to a “pharmaceutical composition for treatment of testosterone deficiency (TD) and/or secondary hypogonadotropic hypogonadism”, are interpreted inasmuch as they relate to a pharmaceutical composition, structurally, affording no patentable weight to “for treatment of testosterone deficiency (TD) and/or secondary hypogonadotropic hypogonadism” as a result of its intended use providing no structural limitations to the Instant invention. Also, no patentable weight is afforded to "amenable to packaging into individual dosage forms", as the limitation is inherent to the property of being a loose, dry powder.
Additionally, Claim(s) 2, and 6-8, citing reference to “enclomifene” are interpreted inasmuch as the formula (E)-2- (4-(2-chloro-1,2-diphenylvinyl)phenoxy)-N,N-diethylethan-1-amine also pertains to the common spellings of “enclomiphene”, “trans-clomiphene”, and “trans-clomifene”, further supported by the Instant specification in [0036-0037] and the compound CAS No. 15690-57-0, which is trans-clomiphene). In the cases where the term trans-clomiphene, here or elsewhere, may refer to the pharmaceutically acceptable citrate salt CAS No. 7599-79-3, enclomiphene citrate, claims citing reference to “enclomifene” will also be interpreted in accordance with the specification [0037] inasmuch as the citrate-containing species of CAS No. 7599-79-3 is also trans-clomiphene.
Additionally, Claim(s) 6-8, citing reference to “zuclomifene” are interpreted inasmuch as the formula (Z)-2- (4-(2-chloro-1,2-diphenylvinyl)phenoxy)-N,N-diethylethan-1-amine also pertains to the common spelling of “zuclomiphene”, “cis-clomiphene” , and “cis-clomifene”.
Additionally, Claim(s) 7 and 8, citing reference to wt% ranges for enclomifene citrate, are interpreted inasmuch as those wt% ranges reference the disclosed compositional mass range (100-300 mg) and correspond to a mass range of 15-75 mg enclomifene, and conversely a fraction of the remainder to comprise microcrystalline cellulose.
Claim Rejections - 35 USC § 102
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(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 1-3, and 5, are rejected under 35 USC 102 as being unpatentable over Podolski et al. (Priority Filing: 26 September 2016; US 2020/0030259 A1; henceforth Podolski).
In regards to Claim 1-3, and 5 Podolski teaches compositions and methods for treating obesity and related symptoms in males by administering an antiestrogen, such as a selective estrogen receptor modulator (SERM), specifically trans-clomifene and addresses several of the limitations of the Instant pharmaceutical composition.
Podolski teaches, in some embodiments, the subject to be treated according to the therein described methods by administration of an antiestrogen, within preferred embodiments the antiestrogen being a selective estrogen receptor modulator (SERM) such as trans-clomiphene or a salt or analogue thereof (pg. 1; [0008]; lines 1-5), as required by Claim 1, line 03; also Claim 2, line 03. Furthermore, Podolski also teaches, in some aspects, the antiestrogen be administered in a composition comprising a pharmaceutically acceptable carrier, excipient or diluent (pg. 1; [0008]; lines 5-8), as required by Claim 1, line(s) 04-05. Additionally, Podolski also teaches these pharmaceutical compositions, in some embodiments, to be formulated into solid dosage units such as tablets, (e.g. suspension tablets, bite suspension tablets, rapid dispersion tablets, chewable tablets, effervescent tablets, bilayer tablets, etc.), caplets, capsules (e.g., a soft or a hard gelatin capsule), powder (e.g. a packaged powder) (pg. 4; [0036]; lines 1-11), as required by Claim 1, lines 06-07; also Claim 3, line(s) 01-03. Podolski also teaches a preferred embodiment, wherein a composition “entirely devoid of estrogenically active substances” comprises about 100% w/w trans-clomiphene and about 0% w/w cis-clomiphene as active agent (pg. 2; [0022]; lines 18-19), as required by Claim 1, line 08,
Podolski teaches that compositions of their invention can, if desired, include one or more pharmaceutically acceptable excipients, defining excipients as any substance, not themselves a therapeutic agent, but used as a carrier or vehicle for delivery of a therapeutic agent to a subject or added to a pharmaceutical composition to improve its handling or storage properties or to permit or facilitate formation of a unit dose of the composition. Podolski proves several examples of excipients that may be included, by way of illustration and not limitation, and comprise diluents, disintegrants, binding agents, adhesives, wetting agents, lubricants, glidants, surface modifying agents or surfactants, fragrances, suspending agents, emulsifying agents, nonaqueous vehicles, preservatives, antioxidants, adhesives, agents to adjust pH and osmolarity (e.g. buffering agents), preservatives, thickening agents, sweetening agents, flavoring agents, taste masking agents, colorants or dyes, penetration enhancers and substances added to improve appearance of the composition." (pg. 5; [0041]; lines 1-17), as required by Claim 5, line(s) 01-03.
Thus, the teachings of Podolski anticipate Claim(s) 1-3, and 5 as described above
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 4 and 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over Podolski (Priority Filing: 26 September 2016; US 2020/0030259 A1) as applied to claims 1-3 and 5 above and in view of van As (Published: 12 February 2013; US 8372887 B2).
In regards to Claim(s) 4 and 6-8, Podolski teaches compositions and methods for treating obesity and related symptoms in males by administering an antiestrogen, such as a selective estrogen receptor modulator (SERM), specifically trans-clomifene and addresses several of the limitations of the Instant pharmaceutical composition.
In regards to Claim 7, citing reference to the range of abundance for the constituents of the composition, Podolski also meets the limitations set forth in the Instant invention by teaching in the claims of their disclosure the method of [Podolski] claim 1, wherein the human male is administered trans-clomiphene or an analogue or pharmaceutically acceptable salt thereof in an amount of from about 5 mg to about 100 mg, the composition being substantially free of cis-clomiphene (pg. 6; Claim 4; lines 1-5), overlapping with the herein disclosed “15 wt.% to about 25 wt.%” enclomifene citrate range of a “100 mg to about 300 mg” composition, as required by Claim 7, line(s) 02-03. A prima facie case of obviousness can be made for the remainder from a threshold amount of administered composition (~100 mg), after accounting for trans-clomiphene 5-100%, to comprise carrier in, at most, the 75-85% range, as required by Claim 7, line(s) 03-04.
Additionally, Podolski also teaches these pharmaceutical compositions, in some embodiments, to be formulated into solid dosage units such as tablets, (e.g. suspension tablets, bite suspension tablets, rapid dispersion tablets, chewable tablets, effervescent tablets, bilayer tablets, etc.), caplets, capsules (e.g., a soft or a hard gelatin capsule), powder (e.g. a packaged powder) (pg. 4; [0036]; lines 1-11), which include gelatin capsules, as required by Claim 8, line(s) 01-02.
Podolski teaches a preferred embodiment, wherein a composition “entirely devoid of estrogenically active substances” comprises about 100% w/w trans-clomiphene and about 0% w/w cis-clomiphene as active agent (pg. 2; [0022]; lines 18-19), as required by Claim 6, line 01-02; also Claim 6, line 03-04.
In regards to Claim(s) 4 and 6-7, citing reference to the identity of the carrier being microcrystalline cellulose, Podolski addresses this particular limitation by teaching the carrier of their invention to be a pharmaceutically acceptable one (pg. 4; [0036]; line 4), but does not teach the use of, specifically, microcrystalline cellulose.
van As, however, teaches similar compositions of clomiphene enriched for trans-clomiphene for treating metabolic syndrome and associated conditions in subjects with low or low normal testosterone. van As meets the limitation of the microcrystalline cellulose use in the trans-clomiphene composition being microcrystalline cellulose by teaching suitable diluents, therein, to include microcrystalline cellulose as exemplary species of celluloses more generally (pg. 21; col. 13; lines 35-47), as required by Claim 4, line(s) 01-02; also Claim 6, line(s) 02-03; also Claim 7, line(s) 03-04.
Taken together, a prima facie case of obvious can be made for one of ordinary skill in the art to combine the teachings of Podolski, with further specification from van As for specifically using a microcrystalline cellulose carrier, to create the pharmaceutical composition disclosed in the Instant application. One of ordinary skill in the art would be motivated to use microcrystalline cellulose, specifically, as the carrier due to its use within similar trans-clomifene compositions as to the Instant disclosure, thereby providing a reasonable expectation of success by doing so.
Thus, Claim(s) 4 and 6-8 are rejected under 35 U.S.C. 103 for the reasons discussed above.
Conclusion
No claims are allowed in this action.
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/STANLEY BRAM/Examiner, Art Unit 1691
/S.B./Examiner, Art Unit 1691
/RENEE CLAYTOR/Supervisory Patent Examiner, Art Unit 1691
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