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 Claims
Claims 1-10, 12, 14-20, 23, and 24 are pending and under current examination.
Election/Restrictions
Applicant's election with traverse of Group I, claims 1-10, 12, 23, and 24 in the reply filed on 8/26/26 is acknowledged. The traversal is on the ground(s) that the three groups include “a common special technical feature” and that Verwey includes a different polymer structure thereby not teaching the “common special technical feature”; Applicant further traverses that there is no serious burden to the Examiner to search and examine all claims. While the argument of no undue search burden is not persuasive, in view of the absence of prior art anticipating or rendering obvious the claimed invention, upon further review, Applicant’s argument is persuasive. No claim is in condition for allowance at this time, however, claims 14-20 are rejoined and the restriction requirement mailed 6/29/26 is withdrawn. All pending claims are fully examined for patentability under 37 C.F.R. 1.104.
In view of the withdrawal of the restriction requirement as to the rejoined inventions, applicant(s) are advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application. Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
Claim Rejections - 35 USC § 112(b)
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, 12, 14-20, 23, and 24 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.
Claim 1 recites a “water-soluble” and at least partially thiolated poly(styrene-co-maleic acid) polymer in lines 2-3 and a “water-soluble” cross-linking agent in line 4. What are the metes and bounds of what constitutes water-solubility and is this term uniform to each of the two agents modified or is solubility a function of agent modified? The specification as filed at page 7, lines 9-10 mentions water-solubility of a telechelic polymer and a system in solution, however the meaning of this term relative to the polymer and the agent modified in claim 1 is not defined in the specification as filed, and an interpretation of what constitutes sufficient solubility to meet the claim may reasonably vary from one artisan to another. All remaining claims under examination require all limitations of claim 1 and are therefore rejected here also.
Appropriate clarification is required.
Claim Rejections - 35 USC § 112(a), Scope of Enablement
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 1-10, 12, 14-20, 23, and 24 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for the claimed polymer system for forming a hydrogel comprising a water-soluble and at least partially thiolated poly(styreneco-maleic acid) polymer having a specific molecular weight and/or functionalization, in combination with a water-soluble cross-linking agent with reactive functional groups at its ends configured as claimed, does not reasonably provide enablement for all combinations of (a) poly(styrene-co-maleic acid) polymers and (b) cross-linking agent with reactive functional groups at its ends wherein the latter are configured to function as further specified in the claims. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims since selections of the polymer of lines 2-3 of claim 1, a cross-linking agent of line 4 of claim 1, and configuration to function as further specified in the last three lines of claim 1.
The specification as filed at the paragraph bridging pages 1 and 2 discloses a specific copolymer of styrene and maleic anhydride having a specified molecular weight in combination with DMSO for conversion to poly(styrene-co-maleic acid essentially in vivo or upon application in use. Similarly, on page 2 of the specification as filed, VasalgelTM is disclosed as a higher molecular weight poly(styrene-co-maleic acid) polymer for similar application. Applicant’s specification details that the instant invention essentially is an improvement over these prior art standards, however the claim language and especially claim 1 does not find support for evidence of unexpected results commensurate in scope with what is claimed. It appears that not only is the instant invention as broadly defined in the claims a result of the claimed combination of polymers but also a function of molecular weight of components, particular crosslinking points, and molar ratios of formulation components and/or reaction conditions. It would require undue experimentation across the breadth of the claim to ascertain what components work for the intended contraceptive results or even hydrogel formulation as claimed. The level of ordinary skill in the art may be considered a master’s degree in chemistry or equivalent, nevertheless, enablement across the full scope claimed remains lacking even when interpreted in view of the level of skill of a skilled artisan. Due to a lack of predictability in the art with regard to hydrogel formation and due to the limited amount of direction provided by the inventor and the limited existence of working examples (see Table 2 of the specification as filed), it is the examiner’s position that the entire scope of what is claimed lacks enablement to make and use the invention as claimed.
Conclusion
No claim is allowed at this time. The prior art does not reasonably teach with sufficient specificity rationale for modifying the nearest art, Angela Colagross-Schouten et al., “The contraceptive efficacy of intraves injection of Tasalgel™ for adult male rhesus monkeys;, Basic and Clinical Andrology, Biomed Central Ltd., London, UK; vol 27, no. 1. 7 February 2017, pages 1-7; DOI 10.1186/S12610-017-0048-9, which the contraceptive product for intravas injection of Vasalgel TM which consists of poly(styrene-co-maleic anhydride) in DMSO.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AUDREA B CONIGLIO whose telephone number is (571)270-1336. The examiner can normally be reached Monday - Thursday 7:00 a.m. - 5:30 p.m..
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Hartley can be reached at 5712720616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AUDREA B CONIGLIO/Primary Examiner, Art Unit 1617
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