DETAILED ACTION
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 .
Status of the Application
This Office Action is in response to Applicant's arguments filed on October 30, 2025. Claim(s) 1-9, 14-16, and 26-27 are pending. Claim(s) 1-8 are withdrawn. Claim(s) 9, 14-16, and 26-27 are examined herein insofar as they read on the elected invention and species.
Response to Arguments
In view of Applicant’s amendments, the 102 (a)(1) rejection of claims 9, 14, and 15 as being anticipated by Wang (US 20160051565) is hereby withdrawn.
In view of Applicant’s amendments, the 103 rejection of claims 16, 17, and 26-27 as being unpatentable over Wang (US 2016/051565) as applied to claims 9, 14, and 15 in the 102(a)(1) rejection above is hereby withdrawn.
Any rejection from the previous Office action not set forth on record below is hereby withdrawn.
The new rejection(s) is/are made in the Final Office action below as necessitated by amendment.
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 (i.e., changing from AIA to pre-AIA ) 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 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.
Claims 9, 14-16, and 26-27 are rejected under 35 U.S.C. 103 as being unpatentable over DePietro (US 2006/0280783) of record.
DePietro teaches a method of transdermal testosterone delivery to a subject comprising topically applying to an area of skin of a subject a transdermal composition comprising: an androgenic compound; and a volatile carrier; and at least one dermal penetration enhancer; and at least one viscosity modulating agent ([0017]; claims 16), wherein the androgenic compound is testosterone (claim 17).
DePietro teaches the composition is preferably applied to those areas of skin which provide maximal systemic absorption due to increased cutaneous blood flow and heat. These areas may be one of more of the axilla, scrotum, planter arch of foot, palm of hand or forehead. Preferably the area is at least one axilla [0059].
DePietro teaches the composition may be used to treat a wide variety of conditions responsive to testosterone therapy such as hypogonadism (primary and secondary), AIDS Wasting Syndrome, micropenis, somatopause, andropause, viropause, or androgen deficiency in adult males (ADAM), anaemia from renal dialysis or chronic kidney disease, benign prostatic hyperplasia, acne, diabetes, infertility, libido, periodontal disease, post-anabolic steroid abuse, dry eyes, diabetic retinopathy, retinopathy, and Lupus Erythematosis, decreased bone density (i.e. osteoporosis), hyperlipemia, predisposition toward prostrate cancer, heart disease, angina, and hypertension [0212].
DePietro teaches a specific example wherein testosterone is present at a concentration of 1% [0221].
DePietro is silent on the age of the human subject, specifically as to whether the subject is pediatric, as required by the limitations of claim 27.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have employed the transdermal pharmaceutical composition of testosterone for the treatment of hypogonadism, by way of example, as taught by DePietro and administered in amounts of 0.01 mg to 10 mg daily to an adult or child. As those skilled in the art recognize, many factors that modify the action of the composition herein will be taken into account by the treating physician such as the age, body weight, sex, diet and condition of the patient, the time of administration, the rate and route of administration, and so forth. Optimal dosages for a given set of conditions can be ascertained by those skilled in the art using conventional dosage determination tests in view of the experimental data provided herein. Generally, mere optimization of ranges will not support the, patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "When the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimal or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); see also In re Peterson, 315 F. 3d at 1330, 65 USPQ 2d at 1382 "The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages." MPEP 2114.04.
The difference between DePietro and the claimed invention is that it does not teach the invention with particularity so as to amount to anticipation (See M.P.E.P. § 2131: "[t]he identical invention must be shown in as complete detail as is contained in the ... claim." Richardson v. Suzuki Motor Co., 868 F.2d 1226, 1236, 9 USPQ2d 1913, 1920 (Fed. Cir. 1989). The elements must be arranged as required by the claim, but this is not an ipsissimis verbis test, i.e., identity of terminology is not required. In re Bond, 910 F.2d 831,15 USPQ2d 1566 (Fed. Cir. 1990)).
However, based on the above, DePietro teaches the elements of the claimed invention with sufficient guidance, particularity, and with a reasonable expectation of success, that the invention would be prima facie obvious to one of ordinary skill (the prior art reference teaches or suggests all the claim limitations with a reasonable expectation of success. See M.P.E.P. § 2143).
Therefore, based on the foregoing reasons, the instant claims are deemed unpatentable over the cited art.
Conclusion
Claims 9, 14-16, and 26-27 are not allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 extension fee 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.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to Sahar Javanmard whose telephone number is (571)270-3280. The examiner can normally be reached on Monday-Friday, 9:00-5:00 EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James Alstrum-Acevedo can be reached on 571-272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
/SAHAR JAVANMARD/Primary Examiner, Art Unit 1622