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 .
DETAILED ACTION
This action is in response to Applicant’s amendment filed May 18, 2026 in reply to the Non-final Office Action mailed December 17, 2025. Claim 1 has been amended; claims 4, 5, 7-15, 17-43, 46, 48-55, and 57-96 have been canceled; and no claims have been newly added. Claims 2, 3, 44, 45, and 97 have been withdrawn. Claims 1, 6, 16, 47, and 56 are currently under examination.
Withdrawal of Prior Claim Objections
Claim 1 has been satisfactorily amended. Therefore, the objections to claim 1 presented in the Non-final Office Action mailed December 17, 2025 are hereby withdrawn.
Withdrawal of Prior Claim Rejections - 35 USC § 112(a)
The 35 USC 112(a) rejection presented in the Non-final Office Action mailed December 17, 2025 is hereby withdrawn.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1, 6, 16, 47, and 56 are rejected under 35 U.S.C. 103 as being unpatentable over Morley et al. (U.S. Patent Application Pub. No. 2011/0158920), in view of Kryger (U.S. Patent Application Pub. No. 2002/0150625).
Applicant Claims
Applicant’s elected subject matter is directed to a gel composition comprising 10-30 wt% of an oleogel comprising 5-40 wt% of an oily agent including polyoxyethylenated oleic glyceride mixture, and 1-10 wt% of a cellulose polymer, e.g. methylcellulose; and an aqueous gel comprising 0.00001-10 wt% micronized testosterone, 1-10 wt% carbomer, and a bioadhesive (e.g. Hypromellose, i.e. HPMC); wherein all amounts are based on the weight of the gel composition.
Determination of the Scope and Content of the Prior Art (MPEP §2141.01)
Morley et al. disclose a topical composition in the form of e.g. a cream comprising 0.5-2.5 wt% testosterone; 10-30 wt% of an oleogel comprising polyoxyethylenated oleic glycerides and 0.01-5 wt% ethylcellulose; and 70-90 wt% of an aqueous gel comprising 0.3-5 wt% carbomer and hydroxypropylmethylcellulose (HPMC); wherein the testosterone active can be in either or both of the oleogel and the aqueous gel, and wherein the gel composition can include emulsifying agents (abstract; paragraphs 0010, 0024, 0026, 0027, 0031, 0033, 0034, 0053, 0059, 0062, 0069, 0106, 0110, 0113, 0114, 0129, 0161, 0183, 0184).
Kryger discloses a topical composition in the form of e.g. a cream comprising micronized testosterone, wherein the micronized testosterone is present in the amount of e.g. 0.5-25 wt%, and has a particle size of less than 100 microns, more specifically less than 20 microns, and wherein the composition can be topically applied for transdermal delivery of testosterone (abstract; paragraphs 0011, 0012, 0035, 0040, 0065, 0159; claim 20).
Ascertainment of the Difference Between the Scope of the Prior Art and the Claims (MPEP §2141.02)
Morley et al. do not explicitly disclose that the testosterone is micronized, and has a particle size of 0.001 nm to 50 microns. These deficiencies are cured by the teachings of Kryger.
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been prima facie obvious for one of ordinary skill in the art at the time the present application was filed to combine the respective teachings of Morley et al. and Kryger, outlined supra, to devise Applicant's claimed cream.
Morley et al. disclose a topical composition in the form of e.g. a cream comprising 0.5-2.5 wt% testosterone; 10-30 wt% of an oleogel comprising polyoxyethylenated oleic glycerides and 0.01-5 wt% ethylcellulose; and 70-90 wt% of an aqueous gel comprising 0.3-5 wt% carbomer; wherein the testosterone active can be in either or both of the oleogel and the aqueous gel, wherein the gel composition can include emulsifying agents but does not necessarily require a penetration enhancer and/or a non-ionic surfactant, and wherein the composition can be topically applied for transdermal delivery of testosterone (paragraphs 0106, 0110-0113). Since Keyger discloses that micronized testosterone with particle size of e.g. less than 100 microns, more specifically less than 20 microns, can be transdermally delivered in an effective amount via a topical cream; one of ordinary skill in the art would thus be motivated to employ specifically micronized testosterone with particle size of less than 100 microns, more specifically less than 20 microns, in the Morley et al. topical cream composition, with the reasonable expectation of success that the resulting cream composition will transdermally deliver an effective amount of testosterone, and will thus successfully produce the desired physiological and therapeutic effects.
In light of the foregoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Response to Arguments
Applicant's arguments filed May 18, 2026 have been fully considered but they are not persuasive.
i) Applicant contends that although Morely expressly discloses that “testosterone may be included in the oleogel and/or in the aqueous gel”, Morely “does not provide any guidance whatsoever regarding which testosterone derivatives…should be placed in which phase, and under what conditions”; that “Morely does not refer to testosterone in micronized form”; thus “any reference to testosterone in Morely is not a one-size-fits-all proposition”; that “Kryger…does reference micronized testosterone, and specifically discloses dissolving the micronized testosterone in an oily phase, not an aqueous phase”; that “the combined teachings of Morely and Kryger clearly motivate the skilled artisan to place micronized testosterone in the oily phase, not the aqueous phase”, and “therefore, it would not have been obvious to one of skill in the art at the time of filing to include micronized testosterone in an aqueous gel as claimed based in Morely and Kryger”.
The Examiner, however, would like to point out the following:
1. As Applicant recognizes, Morely does indeed expressly disclose that testosterone can be included in the oleogel and/or the aqueous gel. Without question, then, Morely clearly and unequivocally discloses that testosterone can be in the aqueous gel phase, and need not be in the oleogel phase.
2. Regarding Applicant’s assertion that “Morely does not provide any guidance whatsoever regarding which testosterone derivatives…should be placed in which phase, and under what conditions”, it is also clear to one of ordinary skill in the art that Morely does not impose any such limitations on which testosterone can be in the aqueous gel phase and which testosterone must be in the oleogel phase. Only Applicant is attempting to impose such limitations. However, these limitations simply do not exist in Morely. Without question, Morely provides that testosterone generally, in any form, can be in the aqueous phase. Contrary to Applicant’s position, one of ordinary skill in the art would without question recognize that it is in fact a “one-size-fits-all” disclosure, i.e. testosterone generally can be in the aqueous gel phase, not merely select forms of testosterone.
3. Kryger is a secondary reference cited for disclosing that micronized testosterone is a suitable form of testosterone for transdermal delivery. Kryger is not being relied on for disclosing that testosterone can be in the aqueous phase of the topical cream. Morely, the cited primary reference, already discloses that testosterone can be in the aqueous gel phase of a topical cream.
4. Micronized testosterone is testosterone. In stark contrast to Applicant’s assertion, Morely’s disclosure that testosterone can be placed in the aqueous gel simply does not somehow exclude micronized testosterone. Applicant’s assertion that while Morely discloses that testosterone can be in the aqueous phase, yet this somehow excludes micronized testosterone is completely baseless. On the contrary, because micronized testosterone is, in fact, testosterone, one of ordinary skill in the art would readily understand Morely to teach that micronized testosterone, and indeed testosterone in whatever form it may be, can be placed in the aqueous gel.
5. Moreover, it is Morely that is being modified in view of Kryger. Indeed, Morely expressly provides that the testosterone can be in either or both of the oleogel and the aqueous gel. Without question, then, placing the testosterone in the aqueous gel is not going to render Morely unsatisfactory for its intended purpose, even if the testosterone is micronized testosterone. Again, micronized testosterone is testosterone, and Morely discloses that testosterone can be in the aqueous gel phase.
6. Both Morely and Kryger disclose a topical cream containing testosterone. Again, Morely, the cited primary reference, already establishes that testosterone can be in the oleogel and/or the aqueous gel. Kryger is being relied on for the teaching that micronized testosterone in particular is a suitable form of testosterone for transdermal delivery of testosterone when the topical cream is applied to skin. Contrary to Applicant’s assertions, Kryger is not somehow being relied on for placing the micronized testosterone specifically in the aqueous phase. Morely already provides that the testosterone, which would include micronized testosterone, can be in the aqueous phase. Furthermore, in stark contrast to Applicant’s understanding, the prior art rejection is not somehow based on throwing out or tossing aside Morely to then make Kryger the primary reference. More specifically, the prior art rejection is not based on throwing out the teaching of Morely that the testosterone can be in either the oleogel and/or the aqueous gel, and replacing this with a directive that the testosterone must necessarily be in the oleogel.
7. It is further noted that even if the micronized testosterone is contained in both the oleogel and the aqueous gel, this would meet the present claim limitations. While the present claims require micronized testosterone in the aqueous gel phase, they do not exclude the presence of micronized testosterone in the oleogel phase.
8. Finally, regarding Applicant’s assertion that “Kryger…does reference micronized testosterone, and specifically discloses dissolving the micronized testosterone in an oily phase, not in aqueous phase”, it is further noted that Applicant has asserted in their own remarks filed November 10, 2025 that “the skilled artisan, having knowledge of testosterone’s solubility in the oil phase, based on the teachings of the prior art…would know to add it to the aqueous phase if the objective is to disperse or suspend the testosterone”. Indeed, Applicant claims a topical cream in which micronized testosterone is in the aqueous gel phase, despite the specification exemplifying micronized testosterone only in the oleogel phase. Applicant’s specification never states that micronized testosterone is in the aqueous gel phase, and none of the examples show micronized testosterone in the aqueous gel phase. On the contrary, micronized testosterone is exemplified only in the oleogel phase. Yet, Applicant contends now that because Kryger only exemplifies micronized testosterone in the oleogel phase, that this would annihilate any motivation to include it in the aqueous gel phase or that it is simply unfeasible and impossible to do so. Applicant forgets that Morely, the cited primary reference expressly teaches including testosterone in the aqueous gel phase and/or the oleogel phase, and it would be obvious to include it in either one or both. Further, Applicant forgets they want a U.S. Patent for including micronized testosterone in the aqeuous gel phase while exemplifying it only in the oleogel phase. Applicant would appear to be arguing that their own claimed invention is thus not sufficiently enabled. Nevertheless, regardless of what the case may be, in view of the cited prior art, one of ordinary skill in the art would be motivated to employ micronized testosterone in the Morely topical cream, and specifically in e.g. the aqueous phase, with the reasonable expectation that the resulting topical cream will successfully deliver the testosterone via the skin.
For the foregoing reasons, the 35 USC 103 rejection is hereby maintained.
Conclusion
No claims are allowed.
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.
Inquiries
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID BROWE whose telephone number is (571)270-1320. The examiner can normally be reached Monday - Friday, 9:30 AM to 6 PM EST.
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/DAVID BROWE/Primary Examiner, Art Unit 1617
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