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
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on November 10, 2025, that includes a response to the Final Office Action mailed June 9, 2025, has been entered. Claims 1 and 47 have 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 Claims 2, 3, 44, 45, and 97 have been withdrawn.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 Rejections - 35 USC § 112(b)
Claim 1 has been satisfactorily amended. Therefore, the 35 USC 112(b) rejection presented in the Final Office Action mailed June 9, 2025 is hereby withdrawn.
Claim Objections
Claim 1, as now amended, is objected to because of the following:
i) In claim 1, there is an extraneous colon between “comprising” and “an oleogel”, an extraneous colon between “comprising” and an oily agent”, an extraneous semicolon between “an oily agent” and “and a cellulose polymer”, an extraneous colon between “comprising” and “micronized testosterone”.
ii) In claim 1, there should be a semicolon between “50 micrometers” and “wherein”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 6, 16, 47, and 56 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement.
The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1, as now amended, stipulates that the aqueous gel component contains micronized testosterone dispersed therein.
While the specification does disclose that the active can be testosterone, and does disclose that the active can be micronized, it is noted that the active is not limited to testosterone. On the contrary, the specification discloses that the active can be one of a wide variety of chemical compounds. For example, paragraph [0009] discloses the following:
“In some embodiments, the active ingredient can be a hormone, an anti-inflammatory, an analgesic, a narcotic, a phenethylamine, an antineoplastic, a steroid, a 5-alpha reductase inhibitor, a gonadotropin-releasing hormone (GnRH) agonist, a tetrahydrocannabinol, a salt of any of these, or any combination thereof. In some cases, the hormone can be selected from the group consisting of: testosterone; dihydrotestosterone (DHT); estradiol; ethinylestradiol; progesterone; levonorgestrel; desogestrel; a synthetic progesterone; a salt of any of these, and any combination thereof. In some cases, the anti-inflammatory can be selected from the group consisting of diclofenac, ketoprofen, ibuprofen, aspirin, a salt of any of these, and any combination thereof. In some cases, the narcotic can be fentanyl, morphine, methadone, etorphine, levophanol, sufentanil, D-Ala.sup.2, N-MePhe.sup.4, Gly-ol]-enkephalin (DAMGO), butophanol, buprenorphine, naloxone, naltrexone, D-Phe-Cys-Tyr-D-Trp-Orn-Thr-Pen-Thr-NH (CTOP), iprenorphine, b-funaltrexamine, naloxonazine, nalorphine, pentazocine, nalbuphine, codeine, hydrocodone, oxycodone, nalmephene or a salt or any of these. In some cases, the phenethylamine can be selected from the group consisting of dopamine, epinephrine, norepinephrine, phenylephrine, methylphenidate, amphetamine, a salt of any of these, and any combination thereof. In some cases, the antineoplastic can be selected from the group consisting of cyclophosphamide, methotrexate, 5-fluorouracil, doxorubicin, procarbazine, prednisolone, bleomycin, vinblastine, dacarbazine, cisplatin, epirubicin, a salt of any of these, and any combination thereof. In some cases, the steroid can be danazol or a salt thereof. In some cases, the 5-alpha reductase inhibitor can be selected from the group consisting of dutasteride, tamsulosin, finasteride, a salt of any of these, and any combination thereof. In some cases, the GnRH agonist can be selected from the group consisting of leuprolide, buserelin, histrelin, goserelin, deslorelin, nafarelin, triptorelin, a salt of any of these, and any combination thereof.”
Moreover, while the specification does broadly and generically disclose, e.g. in paragraph [0077], that the “at least one active ingredient can be dispersed or suspended in at least one oleogel and/or in at least one aqueous gel”, the paragraph further stipulates that the specific property “depends on the choice of active ingredient”. As just noted, the original specification provides for a wide variety of choices for the active ingredient, not just testosterone.
The original specification never actually discloses anywhere at all that testosterone in particular is “dispersed in the aqueous gel”. On the contrary, the examples involving testosterone require the testosterone to be dissolved or suspended in the oily phase, not the aqueous phase.
Hence, the original specification appears to provide insufficient support for this limitation. On the contrary, the original specification would appear to support the opposite, that the testosterone is contained in the oily phase, and thus the oleogel component. It is further noted that the present application is a continuation of U.S. Patent Application No. 15/400,517, and no such claim limitation was ever presented in the parent application.
Applicant argues that the original specification at paragraph [0002] discloses that the gel composition can comprise an active ingredient; that paragraph [0004] stares that “in some embodiments, the at least one active ingredient can be dispersed or suspended in at least a portion of the at least one aqueous gel”; that the specification exemplifies “TESTOCREAM” and that the examples show “compositions having micronized testosterone”. Then Applicant comes to the conclusion that this provides adequate support for the aqueous gel component contains micronized testosterone dispersed therein.
In stark contrast to Applicant’s assertion, however, Applicant has not pointed to any actual support for the limitation that the aqueous gel component contains micronized testosterone dispersed therein. The statement in paragraph [0004] that “in some embodiments, the at least one active ingredient can be dispersed or suspended in at least a portion of the at least one aqueous gel” is not adequate support for testosterone in particular in view of what has already been addressed. Again, testosterone is not the only active ingredient. Again, while the specification does broadly and generically disclose, e.g. in paragraph [0077], that the “at least one active ingredient can be dispersed or suspended in at least one oleogel and/or in at least one aqueous gel”, the paragraph further stipulates that the specific property “depends on the choice of active ingredient”. Hence, the statement ““in some embodiments, the at least one active ingredient can be dispersed or suspended in at least a portion of the at least one aqueous gel” does not necessarily apply to testosterone at all.
Again, the original specification never actually discloses anywhere at all that testosterone in particular is, in fact, “dispersed in the aqueous gel”. On the contrary, the examples involving testosterone require the testosterone to be dissolved or suspended in the oily phase, not the aqueous phase.
Further, in the response filed November 10, 2025, Applicant contends that the specification expressly discloses that the active can be testosterone, that the testosterone can be micronized, and that the active “can be in either the oily phase or the aqueous phase”, and Applicant goes so far as to contend that “the skilled artisan, having knowledge of testosterone’s solubility in the oil phase, based on the teachings of the prior art and of the present disclosure, would know to add it to the aqueous phase if the objective is to disperse or suspend the testosterone, rather than dissolve it”.
This is not found persuasive for the following reasons:
i) First, contrary to Applicant’s assertion, the original specification and claims never actually make a broad and general statement that any active mentioned in the specification can be in either the oil phase or the aqueous phase, depending merely on one’s own preference. That is not what is disclosed at all. What is disclosed is what has already been discussed, i.e. that the “at least one active ingredient can be dispersed or suspended in at least one oleogel and/or in at least one aqueous gel”, the paragraph further stipulates that the specific property “depends on the choice of active ingredient”. Hence, the statement “in some embodiments, the at least one active ingredient can be dispersed or suspended in at least a portion of the at least one aqueous gel” does not necessarily apply to testosterone at all.
ii) Second, the original specification never actually discloses that the testosterone, micronized or not, can be in the aqueous phase. On the contrary, all the examples with testosterone in the original specification employ testosterone in the oily phase. Indeed, Applicant simply did not contemplate at the time of filing employing testosterone in the aqueous phase. Support must come from the original specification and claims. Applicant’s contention that the support for employing testosterone in the aqueous phase is based on “having knowledge of testosterone’s solubility in the oil phase, based on the teachings of the prior art” and from this knowledge of the prior art one of ordinary skill in the art would somehow make the leap to employing testosterone in the aqueous phase is not the proper standard for ascertaining what is supported by the actual disclosure of the original specification and claims.
This constitutes new matter.
Claims 6, 16, 47, and 56 depend from claim 1.
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 November 10, 2025 have been fully considered but they are not persuasive.
i) Applicant contends that “although Kryger discloses micronized testosterone, it discloses dissolving the micronized testosterone in an oily phase, not an aqueous phase”; that “Morley does provide that the testosterone can be in either or both of the oleogel and the aqueous gel” but “Morley, however, discloses testosterone, not micronized testosterone”; therefore, “the combined teachings of Morely and Kryger instruct the skilled artisan to place micronized testosterone in the oily phase, not the aqueous phase”; moreover, “Kryger teaches adding micronized testosterone to an oily phase…to provide testosterone that is rapidly absorbed through the skin” while “the Declaration of Mr. Oliver Bates submitted October 8, 2024 teaches that “adding the micronized testosterone to the aqueous phase is advantageous for sustaining the effect of testosterone over a long period of time, which reduces the number of applications required for therapy”; thus “combining Morley and Kryger” renders the composition “unsatisfactory” for Kryger’s intended use.
The Examiner, however, would like to point out the following:
1. Applicant has the cart before the horse. Morely, not Kryger, is the cited primary reference. In stark contrast to Applicant’s understanding, Kryger is not somehow being modified in view of Morely. On the contrary, 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.
2. Micronized testosterone is testosterone. In stark contrast to Applicant’s assertion, Morely’s disclosure that testosterone can be placed in the oleogel and/or the aqueous gel simply does not somehow exclude micronized testosterone. On the contrary, because micronized testosterone is, in fact, testosterone, one of ordinary skill in the art would understand Morely to teach that micronized testosterone, and indeed testosterone in whatever form it may be, can be placed in the oleogel and/or the aqueous gel.
3. 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.
4. It is further noted that even if the micronized testosterone in 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 phase, they do not exclude the presence of micronized testosterone in the oleogel.
5. Finally, it is further noted that while Applicant contends that Kryger discloses “dissolving the micronized testosterone in an oily phase”, 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”. Nevertheless, even without Applicant’s own admission, 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.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sue Liu can be reached at 571-272-5539. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/DAVID BROWE/Primary Examiner, Art Unit 1617