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
Acknowledgement is made of Applicant’s remarks and amendments filed on 29 April 2026, noting cancellation of Claim(s) 2 and 4, amendment of Claim(s) 1 and 7, and addition of Claim(s) 16-20.
Claim(s) 1, 3, 5-8, and 16-20 are examined on the merits herein.
Claim(s) 9-15 remain withdrawn from further consideration by the examiner, pursuant to 37 CFR 1.142(b), as being drawn to a non-elected invention in the response filed on 02 March 2026 to the restriction requirement.
Rejections and Response to Arguments
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated (Maintained Objections and/or Rejections) or newly applied (New Objections and/or Rejections, Necessitated by Amendment or New Objections and/or Rejections, NOT Necessitated by Amendment). They constitute the complete set presently being applied to the instant application.
Claim Interpretation
Claim interpretation, herein, is based upon MPEP 2111.02(I) pertaining to the effect of the preamble of a claim.
Claim 1, citing reference to “entirely devoid of estrogenically active substances” is interpreted inasmuch as it pertains to the purification products of isomeric mixtures being nearly devoid of all but one isomer, as in the case of chemical species.
Claim(s) 1, 7, and their dependent claims, citing reference to a “pharmaceutical composition for treatment of testosterone deficiency (TD) and/or secondary hypogonadotropic hypogonadism” or “pharmaceutical capsule”, are interpreted inasmuch as they relate to a pharmaceutical composition or capsule, 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) 1 and its dependent claims, 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) 19-20, citing reference to “microcrystalline cellulose functions as both a bulk filler and a disintegrant” and “configured to expand in size in response to being in contact with water”, respectively, are interpreted inasmuch as the composition simply comprises microcrystalline cellulose, as no patentable weight is applied to the identified inherent properties and processes of microcrystalline cellulose in situ.
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) 1, 3, 5-8 and 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over van As (Published: 12 February 2013; US 8372887 B2), as applied to claims 1, 3, and 5-6 above, in view of G&G Food Supplies (Published: 07 October 2020; What is an HPMC Capsule) and Jain et al (Published: December 1984; Journal of Pharmaceutical Sciences, 73(12), pgs. 1806-1811; henceforth Jain).
van As teaches compositions of clomiphene enriched for trans-clomiphene for treating metabolic syndrome and associated conditions in subjects with low or low normal testosterone. In doing so, van As addresses several limitations of the Instant disclosure.
Claim(s) 1 and 5-6 describe a composition comprising enclomifene (or a pharmaceutically acceptable salt) and microcrystalline cellulose such that it is in the form of a loose, dry powder that is devoid of estrogenically active substances; an additional excipient is optional. In regards to Claim 1, van As teaches a composition comprising a mixture of trans-clomiphene (100%) that is entirely devoid of cis-clomiphene (0%) [Col. 3; lines 35-41] with the addition of a microcrystalline cellulose as a pharmaceutically acceptable disintegrant [Col. 14; line 01] that can be in the form of a packaged, or dispensable, powder [Col. 12; lines 17-22], and therefore meets all limitations of the mentioned claim.
Claim 3 describes a pharmaceutical dosage form comprising the composition of Claim 1 and a capsule. In regards to Claim 3, van As meets these limitations by teaching that their solid dosage units of the pharmaceutical composition may be in the form of capsules [Col. 12; lines 14-21].
Claim(s) 1 and 7 also detail their compositions to be immediate release compositions, where “immediate release” is defined in the specification to mean a pharmaceutical dosage form designed to fall apart, dissolve, or otherwise disintegrate as quickly as possible [0042, lines 12-13]. Therefore, van As meets this limitation by teaching embodiments of their compositions wherein the composition takes the form of an effervescent powder [Col. 12, line 22], which falls apart / dissolves / disintegrates “as quickly as possible” by nature of its effervescent quality – referring to the space-generating capacity of gas formation from an effervescent powder exceeding the space-generating capacity of gastric acid-mediated dissolution, as it pertains to breaking apart the composition so as to be immediate release.
In regards to Claim(s) 7 and 19-20, van As teaches trans-clomiphene compositions as described above. Additionally, van As meets the range limitations by teaching trans-clomiphene at a dosage between 1-200 mg [Col. 17; lines 62-64], and disintegrant (i.e. microcrystalline cellulose) to constitute 0.2 to 30 % [Col. 14; lines 09-10]. With regards to ranges, it is noted that “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claim(s) 8 and 16 detail the invention to comprise the composition of Claim 7, wherein the capsule is made of gelatin, or comprises a hard shell, respectively. In regards to the mentioned claims, van As meets these limitations by teaching their solid dosage units for the pharmaceutical composition to come in the form of hard gelatin capsules [Col. 12; line 21].
Claim 18 details the invention to contain a capsule comprising hydroxypropyl methylcellulose (HPMC). In regards to Claim 18, van As meets this limitation by teaching HPMC so be a pharmaceutically acceptable binding agent in tableted forms of the composition. Additionally, G&G Food Supplies teaches that HPMC capsules are tasteless and dissolve in 5-10 minutes, as opposed to 20 minutes for gelatin capsules [par. 05-06]. The compatibility of HPMC in the formulations of van As, in conjunction with the teachings of G&G Food Supplies, offer a prima facie case of obviousness for one of ordinary skill in the art to utilize this common, compatible polymer as a capsule shell for the taught SERM formulation. One of ordinary skill in the art would be motivated to do so provided the abundant usage of HPMC as a capsule material for supplements, as taught by G&G Food Supplies, and be met with a high expectation of success in doing so, to produce the claimed invention before the filing date the Instant disclosure.
However, van As does not teach their hard capsule shells to be laser-drilled with a plurality of holes.
Claim 17 details the invention to further comprise a plurality of laser-drilled holes. In regards to Claim(s) 17, Jain teaches the laser-drilling of hard-shell gelatin capsules to allow for 0.1 M HCl ingress and permit the passage of encapsulated tetracycline HCl in response to a simulated gastric fluid [Abstract; lines 02-06]. A prima facie case of obviousness can be made for one of ordinary skill in the art to encapsulate the compositions of van As within the laser-drilled capsules of Jain, to produce the invention detailed by the mentioned claim. One of ordinary skill in the art would be motivated to do so provided that hard shell gelatin capsules may necessitate laser-drilled holes for facilitating ingress of the gastric fluid and permitting the outward passage of encapsulated compositions, so as to be immediate release inasmuch is that pertains to dissolution “as quickly as possible”; laser-drilled holes would increase the possibility of quick(er) dissolution. In doing so, one of ordinary skill in the art would be met with a high expectation of success, therefore supporting Jain meeting the imposed limitations of the mentioned claim.
Applicant argues:
Applicant contends, regarding the pharmaceutical composition of Claim 1 and its dependent claims, a lack of motivation for one of ordinary skill in the art to select microcrystalline cellulose (MCC) from among the many carriers listed in the art of record (i.e. Podolski, van As), provided the teachings of the Instant specification for a novel observation of MCC to act as both an immediate release disintegrant and carrier.
Examiner's response:
The above argument has been carefully considered and has NOT been found persuasive.
Under KSR International Co. v. Teleflex Inc. (KSR), 550 U.S. 398, 82 USPQ2d 1385 (2007), combining known elements is obvious if the improvement is the predictable use of prior art elements according to their established functions. Since van As disclosed MCC as a standard, well-known pharmaceutical carrier, its selection is a routine "design choice" or a matter of "obvious to try" among a finite, predictable set of standard excipients. Therefore, one of ordinary skill in the art would be motivated to select MCC based on standard formulation parameters (e.g., tableting properties, flowability) rather than inventive insight of its herein proposedly novel, yet inherent, dual property over the course of routine screening of common cellulose-based excipients for powders. According to MPEP 2112(I), newly discovered properties of a known material are inherently non-patentable if the prior art renders the itemized composition as obvious. In conjunction to the use of MCC itself being obvious by the art of record, the "dual functionality" is simply interpreted as an inherent property rather than the proposed unexpected result.
Applicant argues:
Applicant contends, regarding the pharmaceutical composition of Claim 1 and its dependent claims, that the art of record’s focus on slow-release formulations discourages immediate-release SERM formulations of the Instant disclosure, thus "teaching away".
Examiner's response:
The above argument has been carefully considered and has NOT been found persuasive.
According to MPEP 2145(X)(D)(1), a reference does not teach away unless it criticizes, discredits, or actively discourages the claimed solution. The art of record, specifically van As, teaches that dosages are preferably (but not necessarily) administered as part of a dosage regimen designed to give rise to serum testosterone levels that mimic or correspond to the normal secretory total serum testosterone profile [Col. 7; lines 07-10], and proposes such compositions may be in the form of sustained release formulations as also taught in their cited art [Col. 7; lines 15-25]. Doing so does not discourage, neither explicitly nor implicitly, use of immediate release SERM formulation, but simply discloses a different formulation protocol or release profile without actively disparaging immediate-release mechanisms. In fact, formulations taught by the art of record possibly default to an immediate release formulation, and provide rationale for mitigating possible side effects by providing sustained-release alternatives. In addition, van As teaches several embodiments of their compositions which promote dissolution “as quickly as possible”, for example:
- rapid dispersion tablets [Col. 12; line 19]
- effervescent tablets [Col. 12; line 20]
- effervescent powder [Col. 12; line 22]
- powder aerosol [Col. 12; line 24]
Thus, Claim(s) 1, 3, 5-8 and 16-20 are rejected under 35 U.S.C. 103 for the reasons discussed above.
Conclusion
No claims are allowed in this action.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STANLEY BRAM whose telephone number is (571)272-8779. The examiner can normally be reached 7:30 - 5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Renee R Claytor can be reached at (571) 272-8394. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/STANLEY BRAM/Examiner, Art Unit 1691
/RENEE CLAYTOR/Supervisory Patent Examiner, Art Unit 1691
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