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 .
Claims 1-15 are pending examination.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 4/15/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
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 1-15 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 the term an “entanglement fluid” which is indefinite. The specification fails to define the metes and bounds of the term and only defines that it may be a silicone with a viscosity above 10000 cS. The term is not art recognized and can read on any compound, solvent, mixture, rheology agent or polymer which entangles a compound. The full scope of what compounds are encompassed by the term cannot be deciphered. It is also unclear how the entanglement fluid differs in function from the crosslinker and the hydrosilylation agent. For the purpose of examination the term as been interpreted to refer to any silicone compound.
Claims 9 and 10 recite viscosity in units “cS” which is indefinite. It is unclear if the term refers to centistokes, which is generally abbreviated as “cSt” or another unit of measure. Units of weights and measures should be in terms of the metric system if that is what is intended. For the purpose of examination the term cS has been treated as “cSt”.
Claims 2-8 and 11-15 are rejected for depending on rejected 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 (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.
Claim(s) 1-6 and 9-15 are rejected under 35 U.S.C. 103 as being unpatentable over Bingol et al. (WO 2016/173600; international filing date April 28, 2016).
Applicant claims a hydrophobic adhesive comprising:
about 25-75wt% crosslinker,
about 25-75wt% entanglement fluid; and
about 0.05-0.3wt% hydrosilylation agent.
Bingol et al. teach adhesive compositions comprising one or more reactive silicone polymers, one or more adhesive components, preferably selected from silicon pressure sensitive polymers, a crosslinker and a catalyst (abstract). The reactive silicone polymers comprise a polysiloxane and the viscosity of the reactive polymers range from 10 to 900,000 cSt at 25˚C and have an average molecular weight ranging from 25,000-125,000 g/mol (page 10, lines 22-30; limitation of claims 9-12). The reactive silicones include PDMS and silicon resins with a molecular weight of at least 10,000 g/mol (page 11, line 17 through page 16, line 12; limitation of claim 5). The crosslinking agent is a silane selected from vinyltrimethoxylsilane, vinyltriethoxysilane (page 16, lines 13-28; limitation of claims 13-15). The hydroxyl terminated PDMS ranges from 2-50wt% of the adhesive (which reads on component a)), the reactive silicone polymer (which reads on component b)) ranges from 5-50wt% of the adhesive and the crosslinker (which reads on component c)) ranges from 0.2-5wt% of the adhesive (page 19, line 33 through page 20, line 22; limitation of claim 6). The adhesive is curable and applied to skin in a liquid state or adhesive state as a pressure sensitive adhesive on ostomy devices seal around the stoma (page 22, lines 3-24). Examples where the ratio of PDMS to resin is adjusted for stickiness are documented (page 33, lines 20-38). The commercially available formulation Trio Stoma gel comprise OH-terminated PDMS as the reactive polymer in an amount of 84wt% (page 34, lines 1-8).
With respect to claims 1, 5, 6 and 9-15, Bingol et al. teach formulations comprising hydroxyl terminated PDMS (a functionalized PDMS) ranging from 2-50wt% of the adhesive, the reactive silicone polymer selected from polysiloxane ranging from 5-50wt% of the adhesive and crosslinker selected from vinyltrimethoxylsilane, vinyltriethoxysilane ranging from 0.2-5wt% of the adhesive. Bingol et al. do not specify hydrosilyation agents, however Bingol teach that the crosslinking agent can be selected from a silanes which range from 0.2-5wt% of the adhesive formulation.
With respect to claims 2-4, Bingol et al. teach gel formulations comprising up to 84wt% PDMS (crosslinker) and silane and adjusting amounts of resin and PDMS to analyze tackiness, therefore one of ordinary skill in the art would have been motivated by routine optimization to adjust the amount of PDMS to amounts of 75wt% to form gel compositions comprising silicones and silanes. Bingol et al. teach 0.2wt% silane but does not specify 0.15wt% or 0.1wt% silane, however a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985).
Therefore, it would have been prima facie obvious to combine Bingol et al. and formulate a composition comprising hydroxyl terminated PDMS ranging from 25-50wt% of the adhesive, polysiloxane ranging from 25-50wt% of the adhesive and the crosslinker selected from silane ranging from 0.2-0.3wt% of the adhesive with a reasonable expectation of success. One of ordinary skill in the art would have been motivated to combine the teachings of Bingol et al. and include silane because Bingol et al. teach crosslinkers are selected from silanes including vinyltrimethoxylsilane and vinyltriethoxysilane ranges from 0.2-5wt% of the adhesive formulation.
Claim(s) 7 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Bingol et al. (WO 2016/173600; international filing date April 28, 2016) as applied to claims 1-6 and 9-15, in view of Stettler et al. (US 2009/0012473; published January 8, 2009).
Applicant claims a hydrophobic adhesive comprising:
about 25-75wt% crosslinker,
about 25-75wt% entanglement fluid; and
about 0.05-0.3wt% hydrosilylation agent.
The teachings of Bingol et al. are addressed in the above 103 rejection.
Bingol et al. curable adhesives comprising functionalized PDMS but do not specify functionalized PDMS containing vinyl groups or platinum catalyzed PDMS. It is for this reason that Stettler et al. is joined.
Stettler et al. teach portable medical devices that can be attached to skin that include silicon-based adhesives (abstract). The silicone-based adhesives are maintained when moisture is involved from perspiration and provide a long wearing life [0011]. The silicone soft skins adhesives are based on crosslinking between vinyl functional polydimethylsiloxanes PDMS and hydrogen functional siloxane and is catalyzed by a platinum complex which results in a PDMS polymer that is gel-like [0011-16].
Bingol et al. and Stettler et al. are both drawn to silicon adhesives used on the skin. Therefore, it would have been prima facie obvious to combine Bingol et al. and Stettler et al. and include vinyl-functionalized PDMS that is platinum catalyzed with a reasonable expectation of success. One of ordinary skill in the art would have been motivated to combine the teachings of Bingol et al. and Stettler et al. include vinyl-functionalized PDMS that is platinum catalyzed because Stettler et al. teach adhesives based on crosslinking between vinyl functional polydimethylsiloxanes PDMS and hydrogen functional siloxane can be catalyzed by a platinum complex produce cross-linked polymers that are gel-like and have long wear life that is maintained even around moisture from skin.
Conclusion
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DANIELLE D. JOHNSON
Examiner
Art Unit 1617
/BETHANY P BARHAM/ Supervisory Patent Examiner, Art Unit 1611