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 .
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 allowance or after an Office action under Ex Parte Quayle, 25 USPQ 74, 453 O.G. 213 (Comm'r Pat. 1935). 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, prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant's submission filed on 2/18/2026 has been entered.
Claims 31-36, 40, 42, 45, 46, 48-60 are pending.
The outstanding rejection under 35 USC 103a is withdrawn in view of the applicant’s arguments along with the amendments to the claims filed 2/18/2026. As the claims are directed to the use of a testosterone undecanoate formulation with specific excipients and amount range, in a specific dosage, to give rise to the herein claimed results of 75% of patients having Cavg in the range of about 300 ng/dL to about 1100 ng/dL, and less than about 5% having Cmax in the range of about 1800 ng/dL to about 2500 ng/dL, the cited prior art does not read on or render the claims obvious.
Claim Rejections - 35 USC § 112
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 31-36, 40, 42, 45, 46, 48-60 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.
The limitation “at least about 75% of the population has a Cav, in the range of about 300 ng/dL to about 1100 ng/dL, and less than about 5% of the population has a Cmax in the range of about 1800 ng/dL to about 2500 ng/dL” recited in claims 31, 52, and 57 is not supported by the originally filed specification or claims.
The limitation “wherein greater than or equal to about 85% of the population has a Cmax below about 1500 ng/dL.” Recited in claim 49, 56, and 60 is not supported by the originally filed specification or claims.
Appropriate correction is required.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAN MING R HUI whose telephone number is (571)272-0626. The examiner can normally be reached Mon - Fri 9:30-5:30.
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/SAN MING R HUI/Primary Examiner, Art Unit 1627
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