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 .
A preliminary amendment was filed on 10/27/2023.
Information Disclosure Statement
An Information Disclosure Statement was filed 04/12/2024.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-10 and 12 in the reply filed on 01/20/2026 is acknowledged.
Claims 11, 13-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 01/20/2026.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-10 and 12 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Applicant claims etonogestrel, or a prodrug, or salt thereof. The term “prodrug” is indefinite in that it could encompass any number of chemicals, wherein the metes and bounds of the term are not particularly pointed out. Clarification is requested.
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.
Claim 1 is/are rejected under 35 U.S.C. 103 as being unpatentable over CN 103446043 (Liaoning Res. Institute).
Liaoning Res. Institute discloses an in situ gel injection implant for sustained release of a drug. Etonogestrel is specifically recited at claim 8. Liaoning Res. Institute differs in that its matrix comprises trimethylene carbonate lactide copolymer (see Example 1, Figure 2, and claims 1-8).
In a related drug delivery system, Medincell teaches that a drug delivery system may comprise a mixture of block copolymers (page 31, lines 1-18). The tri-block copolymer is PLA-PEG-PLA and di-block copolymer is mPEG-PLA (page 31, lines 19-25). The molar ratio of LA to EO in deblock copolymer is 0.8:15, optionally 1:10. The molar ratio of LA to EO in the triblock copolymer is 0.5:22.3; 0.5:10, optionally 0.5:3.5 (claim 27). The gel is injected and forms solid depots in situ (page 27, lines 26-30). DMSO is used as the solvent (page 30, lines 16-17). Therefore, those of ordinary skill would have found it well within their skill to use etonogestrel as the active agent in the injectable gel of Medincell, with a reasonable expectation of contraception over a sustained period of time. The instant claims would have been obvious to one of ordinary skill in the art at the time of filing.
Conclusion
No claims are allowed.
US 2012/172454 (Gaudrialt) is cited as a patent of interest in its disclosure of an injectable liquid which solidifies to form an implant. The liquid comprises a triblock copolymer of PLA-PEG-PLA and a deblock copolymer of mPEG and PLA.
Correspondence
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/CARLOS A AZPURU/ Primary Examiner, Art Unit 1617 caz