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 final rejection. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 02/16/2026 has been entered.
Election/Restrictions
Newly submitted claim 22 directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
Group I, claims 1-2, 4, 6-20, and 23 are drawn to a curable liquid silicone rubber composition.
Group II, claim 22, drawn to a method of preparing a molded silicone rubber comprising curing and molding the curable liquid silicone rubber composition of claim 1.
The groups of inventions listed above do not relate to a single general inventive concept
under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special
technical features for the following reasons:
Groups I and II lack unity of invention because even though the inventions of these
groups require the technical feature of a curable liquid silicone rubber composition this technical feature is not a special technical feature as it does not make a contribution over the prior art in view Bhatt et al. (EP0688564B1, Published 08/04/1999) ) in view of Woolfson et al. (US20090004246A1, Published 01/01/2009) and further in view of Blanda et al. (US20170224823A1, Published 08/10/2017) further in view of Muraoka et al. (US 6077528A, Published 06/20/2000) further in view of Agarwal et al (WO2018083675A1, Published 05/11/2019). Bhatt teaches the method of controlling release of active agents/drugs from a silicon rubber matrix wherein the silicon rubber matrixes are produced by curing a liquid silicone rubber comprised of (a) a polyorganosiloxane containing at least two alkenyl radicals per molecule; (b) an organohydrogensiloxane containing at least two silicon-bonded hydrogen atoms per molecule; and (c) a hydrosilylation catalyst in an amount sufficient to promote curing of said composition (page 2, paragraph [0008]). Bhatt also teaches wherein the polyorganosiloxane (a) must contain at least two silicon-bonded alkenyl radicals in each molecule. Suitable alkenyl radicals contain from 1 to 10 carbon atoms and are exemplified by vinyl (page 2, paragraph [0011]). Bhatt further teaches hydrosilylation catalysts useful in the instant invention are platinum metal, platinum compounds, platinum complexes and others such as rhodium compounds, nickel compounds, palladium metals (paragraph [0022]). Bhatt further teaches finely divided forms of silica are preferred reinforcing fillers. Colloidal silicas are particularly preferred (page 4, paragraph [0032]). Bhatt continues to teach drugs that may be released from the silicone rubber matrix are exemplified by hormonal agents such as estradiol (page 6, paragraph [0045]). Bhatt also teaches wherein the organohydrogensiloxane (b) is present in an amount sufficient to provide a molar ratio of alkenyl radicals in polyorganosiloxane (a) to silicon-bonded hydrogen atoms in the organohydrogensiloxane (b) of from 0.5:1 to 20:1 (page 9, claim 1). The examiner notes that the claimed range falls within the range of Bhatt. Bhatt further teaches platinum catalyst inhibitors such as acetylenic alcohols (i.e., “cure rate controller”) (page 4, paragraph [0027]). Bhatt does not teach from 0.01 to 10% by weight based on total weight of the curable liquid silicone rubber composition of a mixture comprising at least one fatty acid ester and benzotriazole (instant claim 1); a therapeutically effective amount of at least one active pharmaceutical ingredient comprising in its chemical structure at least one terminal alkene, or at least one terminal alkyne (instant claim 1); wherein said fatty acid ester G is formed from an alcohol of 2 to 20 carbon atoms (instant claim 1). However, these deficiencies are cured by Woolfson et al., Blanda et al., and Agarwal et al. In the analogous art of controlled release of drugs, Woolfson teaches an intravaginal drug delivery device wherein at least one drug-containing insert comprises at least one water-soluble release enhancer in an amount ranging from about 1% to about 70% (page 4, paragraph [0044]), wherein the release enhancer includes fatty acid esters, preferably containing 2 to 20 carbon atoms of which myristate esters are preferred (page 4, paragraph [0045]). Woolfson further teaches at least one drug suitable for inclusion in the device body can be antifungals (page 7, paragraph [0066]).
In the analogous art of controlled release of drugs, Blanda teaches intravaginal rings (i.e., drug delivery device) of the invention comprise polysiloxanes (page 9, paragraph [0087]); wherein the intravaginal drug delivery devices further comprises an antimicrobial compound (page 2, paragraph [0016]); wherein antimicrobial compound embraces antifungal agents (page 6, paragraph [0063]) such as fluconazole, terconazole and itraconazole (i.e., triazole compounds) (page 13, paragraph [0132]). Blanda further teaches wherein the antimicrobial agent is present in the ring in a range of 10mg to 1600mg (page 13, paragraph [0143]).
Agarwal et al. teaches the present invention relates to the use of synergistic antimicrobial composition comprising quaternary ammonium compound and antimicrobial active in pharmaceuticals (page 12, lines 13-14). Agarwal further teaches the antimicrobial active of the present invention is selected from the group comprising fluconazole, terconazole, itraconazole, and benzotriazole (page 8, lines 24-29). It would have been obvious to use fatty acid ester in Bhatt’s method of controlling release of a drug from curable silicone liquid silicone rubber composition because Bhatt teaches release additions such as polyethylene glycols and Woolfson teaches release enhancers such as fatty acid esters preferably myristate esters and polyethylene glycols. Therefore, fatty acid esters preferably myristate esters would have been suitable for the purpose of a release additive in Bhatt’s composition. See MPEP 2144.07. It would have been obvious to one of ordinary skill in the art to have a benzotriazole in Bhatt’s method of controlling release of a drug from curable silicone liquid silicone rubber composition because Woolfson teaches an intravaginal drug delivery device comprising a curable liquid silicone that further comprises antifungals as a drug in the device and Blanda teaches antifungal agents used in a intravaginal drug delivery device can be bifonazole, butoconazole, eberconazole, ketoconazole, tioconazole etc. (i.e., triazole compounds)(page 13, paragraph [0132]) which are capable of inhibiting or destroying the growth of a microbial organism (page 12, paragraph [0126]) and Agarwal teaches that antimicrobial actives can be selected from fluconazole, terconazole, itraconazole, and benzotriazole. Therefore, benzotriazole was known to serve the same purpose of an antimicrobial agent in the form of a triazole compound. See MPEP 2144.06 (II). Woolfson teaches an intravaginal drug delivery device wherein at least one drug-containing insert comprises at least one water-soluble release enhancer in an amount ranging from about 1% to about 70% (page 4, paragraph [0044]), and Blanda teaches wherein the antimicrobial agent is present in the ring in a range of 10mg to 1600mg (page 13, paragraph [0143]), therefore it would have been obvious to one of ordinary skill in the art to optimize the amounts of the triazole compound and the fatty acid ester. It would have been obvious to one of ordinary skill in art to have isopropyl myristate in Bhatt’s method of controlling release of a drug from curable silicone liquid silicone rubber composition because Bhatt teaches release additives and Woolfson teaches release enhancers such as fatty acid esters preferably myristate esters and Muraoka teaches that isopropyl myristate is a type of myristate ester. Therefore, isopropyl myristate is suitable in biomedicine as a myristate ester.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claim 22 is withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Status of the claims
Claims 3, 5, and 21 have been cancelled. Claim 22 has been withdrawn.
Claims 1-2, 4, 6-20, and 23 are currently under examination.
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-2, 4, 6-20, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Bhatt et al. (EP0688564B1, Published 08/04/1999) in view of Woolfson et al. (US20090004246A1, Published 01/01/2009) and further in view of Blanda et al. (US20170224823A1, Published 08/10/2017) further in view of Muraoka et al. (US 6077528A, Published 06/20/2000) further in view of Agarwal et al (WO2018083675A1, Published 05/11/2019).
Applicant’s invention
Applicant’s claims are drawn to a curable liquid silicone rubber composition comprising a two-part component system comprising Part A and Part B, wherein, Part A comprises (A) at least one organopolysiloxane having at least two silicon- bonded alkenyl groups per molecule, said alkenyl groups each containing from 2 to 14 carbon atoms, (D) optionally at least one filler selected from the group consisting of finely divided silica, hydrophobic silica hydrogel. surface treated silica, fumed silica and fumed silica in situ treated with hexamethyldisilazane and/or tetramethyldivinyldisilazane, and (C) at least one hydrosilylation catalyst comprising Pt, Rh, Ru, Pd, Ni, or any combinations thereof: Part B comprises (A) at least one organopolysiloxane having at least two silicon- bonded alkenyl groups per molecule, said alkenyl groups each containing from 2 to 14 carbon atoms, (D) optionally at least one filler selected from the group consisting of finely divided silica, hydrophobic silica hydrogel. surface treated silica, fumed silica and fumed silica in situ treated with hexamethyldisilazane and/or tetramethyldivinyldisilazane, (B) at least one organosilicon compound having at least two silicon-bonded hydrogen atoms per molecule, (G)at least one cure rate controller, (E) from 0.01% to 10 % by weight based on total weight of the curable liquid silicone rubber composition of a mixture comprising at least one fatty acid ester and benzotriazole, and (F) a therapeutically effective amount of at least one active pharmaceutical ingredient comprising in its chemical structure at least one terminal alkene, or at least one terminal alkyne, wherein the fatty acid ester is formed from an alcohol of 2 to 20 carbon atoms and a fatty acid.
Determination of the scope and the content of the prior art
(MPEP §2141.01)
Regarding claims 1 and 20, Bhatt teaches the method of controlling release of active agents/drugs from a silicon rubber matrix wherein the silicon rubber matrixes are produced by curing a liquid silicone rubber comprised of (a) a polyorganosiloxane containing at least two alkenyl radicals per molecule; (b) an organohydrogensiloxane containing at least two silicon-bonded hydrogen atoms per molecule; and (c) a hydrosilylation catalyst in an amount sufficient to promote curing of said composition (page 2, paragraph [0008]). Bhatt also teaches wherein the polyorganosiloxane (a) must contain at least two silicon-bonded alkenyl radicals in each molecule. Suitable alkenyl radicals contain from 1 to 10 carbon atoms and are exemplified by vinyl (page 2, paragraph [0011]). Bhatt further teaches hydrosilylation catalysts useful in the instant invention are platinum metal, platinum compounds, platinum complexes and others such as rhodium compounds, nickel compounds, palladium metals (paragraph [0022]). Bhatt further teaches finely divided forms of silica are preferred reinforcing fillers. Colloidal silicas are particularly preferred (page 4, paragraph [0032]). Bhatt continues to teach drugs that may be released from the silicone rubber matrix are exemplified by hormonal agents such as estradiol (page 6, paragraph [0045]). Bhatt also teaches wherein the organohydrogensiloxane (b) is present in an amount sufficient to provide a molar ratio of alkenyl radicals in polyorganosiloxane (a) to silicon-bonded hydrogen atoms in the organohydrogensiloxane (b) of from 0.5:1 to 20:1 (page 9, claim 1). The examiner notes that the claimed range falls within the range of Bhatt. Bhatt further teaches platinum catalyst inhibitors such as acetylenic alcohols (i.e., “cure rate controller”) (page 4, paragraph [0027]). The Examiner points out that the preamble recites a curable liquid silicone rubber composition as a resulting of the mixing of the two component system. The fact that Applicants are describing the composition with its constituent parts is product by process because in order to claim the final product one must combine the two component system, whereas Applicants are claiming the final curable liquid silicon rubber composition. The final product taught in Bhatt is still a curable liquid silicone rubber composition reading to the final product instantly claimed.
Regrading claim 9, Bhatt teaches curing the liquid silicone rubber composition while being molded into a shape (page 9, claim 1). The examiner points out that the instant claims recite a limitation on how the product was made (i.e., curing and molding); however, this does not limit the structural element of the claimed product. "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). See MPEP 2113 (I).
Regarding claims 13 and 14, Bhatt teaches suitable alkenyl radicals contain from 1 to 10 carbon atoms and are exemplified by vinyl, allyl and 5-hexenyl (paragraph [0008]).
Regarding claim 15, Bhatt teaches if polyorganosiloxane (A) contains only two alkenyl radicals per molecule, organohydrogensiloxane (B) must contain an average of more than two (i.e., at least three) silicon-bonded hydrogen atoms to achieve a crosslinked structure in the final cured product (paragraph [0016]).
Regarding claim 16, Bhatt teaches hydrosilylation catalysts useful in the instant invention are platinum metal, platinum compounds, platinum complexes and others (paragraph [0022]).
Regarding claim 17, Bhatt teaches the concentration of catalyst (C) in the present compositions is equivalent to a concentration of from 0.1 to 500 parts by weight of catalyst metal (e.g., platinum metal), preferably from 1 to 50 parts by weight of catalyst metal, per million parts (ppm), based on the combined weight of components (A) and (B) (paragraph [0021]).
Regarding claim 18, Bhatt teaches when a silica filler is used, it is preferably treated in the presence of at least a portion of the other ingredients of the present compositions by blending these ingredients together until the filler is completely treated and uniformly dispersed to form a homogeneous material (paragraph [0032]).
Regarding claim 19, Bhatt teaches colloidal silicas can be a fume type (i.e., fumed silica) (paragraph [0029]). Bhatt also teaches organosilicon compounds such as hexaorganodisiloxanes and hexaorganodisilazanes that hydrolyze under the conditions used to treat the filler to form compounds with silicon-bonded hydroxyl groups (paragraph [0030]). Bhatt further teaches 31wt% of hexamethydisilazane treated silica in the example rubber 3 (paragraph [0051]).
Regarding claim 23, the examiner points out that the limitations of claim 22 which claim 23 depends from are method claims making claim 23 product by process limitations, therefore it is not given patentable weight.
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.02)
Bhatt does not teach from 0.01 to 10% by weight based on total weight of the curable liquid silicone rubber composition of a mixture comprising at least one fatty acid ester and benzotriazole (instant claim 1); a therapeutically effective amount of at least one active pharmaceutical ingredient comprising in its chemical structure at least one terminal alkene, or at least one terminal alkyne (instant claim 1); wherein said fatty acid ester G is formed from an alcohol of 2 to 20 carbon atoms (instant claim 1); wherein the mixture contains from 0.1 to 10% by weight of benzotriazole and from 99.9 to 90% by weight of fatty acid ester (instant claim 2); wherein said fatty acid is selected from the group consisting of caproic acid, lauric acid, myristic acid, oleic acid, linoleic acid, adipic acid and lanolin acid (instant claim 4); wherein said alcohol is an alkanol of 2 to 4 carbon atoms (instant claim 6); wherein said fatty acid ester is isopropyl myristate (instant claim 7); wherein said active pharmaceutical ingredient is chosen from the group consisting of levonorgestrel, ethynyl estradiol, norethisterone, ethynodiol diacetate, desogestrel, lynestrenol, and mixtures thereof (instant claim 8); a drug delivery device comprising a molded silicone rubber (instant claim 10); a drug delivery device prepared via an injection molding apparatus or a compression molding apparatus (instant claim 11); and wherein the drug delivery device is an intravaginal drug delivery device (instant claim 12). However, these deficiencies are cured by Woolfson et al., Blanda et al., Muraoka et al., and Agarwal et al.
In the analogous art of controlled release of drugs, Woolfson teaches an intravaginal drug delivery device wherein at least one drug-containing insert comprises at least one water-soluble release enhancer in an amount ranging from about 1% to about 70% (page 4, paragraph [0044]), wherein the release enhancer includes fatty acid esters, preferably containing 2 to 20 carbon atoms of which myristate esters are preferred (page 4, paragraph [0045]). Woolfson also teaches contraceptives suitable for intravaginal release from the device body levonorgestrel, norethisterone, desogestrel, estradiol, and ethinyl estradiol (page 7, paragraph [0067]). Woolfson further teaches the insert carrier material may be a silicone elastomer (page 6, paragraph [0063]) wherein the insert is prepared by a suitable method such as injection molding (page 6, page [0056]). Woolfson also teaches the drug delivery device is an intravaginal device (page 6, paragraph 0057]). Woolfson further teaches at least one drug suitable for inclusion in the device body can be antifungals (page 7, paragraph [0066]).
In the analogous art of controlled release of drugs, Blanda teaches intravaginal rings (i.e., drug delivery device) of the invention comprise polysiloxanes (page 9, paragraph [0087]); wherein the intravaginal drug delivery devices further comprises an antimicrobial compound (page 2, paragraph [0016]); wherein antimicrobial compound embraces antifungal agents (page 6, paragraph [0063]) such as fluconazole, terconazole and itraconazole (i.e., triazole compounds) (page 13, paragraph [0132]). Blanda further teaches wherein the antimicrobial agent is present in the ring in a range of 10mg to 1600mg (page 13, paragraph [0143]).
In the analogous art of biomedicine, Muraoka teaches specific examples of fatty acid esters include myristates such as isopropyl (i.e., alkanol of 3 carbons) myristate (column 5, lines 12-16).
Agarwal et al. teaches the present invention relates to the use of synergistic antimicrobial composition comprising quaternary ammonium compound and antimicrobial active in pharmaceuticals (page 12, lines 13-14). Agarwal further teaches the antimicrobial active of the present invention is selected from the group comprising fluconazole, terconazole, itraconazole, and benzotriazole (page 8, lines 24-29).
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been prima facie obvious to one of ordinary skill in the arts at the time of filing to a fatty acid ester in Bhatt’s method of controlling release of a drug from curable silicone liquid silicone rubber composition. Bhatt teaches release additives as an additional component which effects the release of the drug or active from the silicone rubber matrix may be added such as polyethylene glycols (page , paragraph [0040]). One would have understood in view of Woolfson that water-soluble release enhancers are selected from polyethylene glycols, fatty acid esters etc., wherein the fatty acid esters preferably containing 2 to 20 carbon atoms, of which myristate esters are preferred (page 4, paragraph [0045]); wherein the “release enhancer” is capable of increasing cumulative release of the drug for a given time period (page 3, paragraph [0034]). It would have been obvious to use fatty acid ester in Bhatt’s method of controlling release of a drug from curable silicone liquid silicone rubber composition because Bhatt teaches release additions such as polyethylene glycols and Woolfson teaches release enhancers such as fatty acid esters preferably myristate esters and polyethylene glycols. Therefore, fatty acid esters preferably myristate esters would have been suitable for the purpose of a release additive in Bhatt’s composition. See MPEP 2144.07.
It would have been prima facie obvious to one of ordinary skill in the art at the time of filing to have benzotriazole in Bhatt’s method of controlling release of a drug from curable silicone liquid silicone rubber composition. Woolfson teaches that the intravaginal drug delivery device can further comprise antifungals as an additional drug in the device (page 2, paragraph [0018]). One would have understood in view of Blanda wherein the intravaginal drug delivery devices further comprises an antimicrobial compound (page 2, paragraph [0016]); wherein antimicrobial compound embraces antifungal agents (page 6, paragraph [0063]) such as fluconazole, terconazole and itraconazole (i.e., triazole compounds) (page 13, paragraph [0132]). One would have further understood in view of Agarwal that antimicrobial actives of the present invention is selected from the group comprising fluconazole, terconazole, itraconazole, and benzotriazole (page 8, lines 24-29). It would have been obvious to one of ordinary skill in the art to have a benzotriazole in Bhatt’s method of controlling release of a drug from curable silicone liquid silicone rubber composition because Woolfson teaches an intravaginal drug delivery device comprising a curable liquid silicone that further comprises antifungals as a drug in the device and Blanda teaches antifungal agents used in a intravaginal drug delivery device can be bifonazole, butoconazole, eberconazole, ketoconazole, tioconazole etc. (i.e., triazole compounds)(page 13, paragraph [0132]) which are capable of inhibiting or destroying the growth of a microbial organism (page 12, paragraph [0126]) and Agarwal teaches that antimicrobial actives can be selected from fluconazole, terconazole, itraconazole, and benzotriazole. Therefore, benzotriazole was known to serve the same purpose of an antimicrobial agent in the form of a triazole compound. See MPEP 2144.06 (II).
With regards to wherein the mixture contains from 0.1 % to 10% by weight of benzotriazole and fatty acid ester, it would have been obvious to one of ordinary skill in the art to vary the amounts of the fatty acid ester and the triazole compound depending on the desired result. Woolfson teaches an intravaginal drug delivery device wherein at least one drug-containing insert comprises at least one water-soluble release enhancer in an amount ranging from about 1% to about 70% (page 4, paragraph [0044]), and Blanda teaches wherein the antimicrobial agent is present in the ring in a range of 10mg to 1600mg (page 13, paragraph [0143]), therefore it would have been obvious to one of ordinary skill in the art to optimize the amounts of the triazole compound and the fatty acid ester. Determining optimal concentrations is routine experimentation and is practiced by one of ordinary skill. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F. 2d 454, 105 USPQ 233 (CCPA 1955). In addition, according to the MPEP, “It is to be presumed also that skilled workers would as a matter of course, if they do not immediately obtain desired results, make certain experiments and adaptations, within the skill of the competent worker.” (MPEP 716.07).
With regards to the limitations wherein at least one active pharmaceutical ingredient comprises in its chemical structure at least one terminal alkene, or at least one terminal alkyne, wherein said active pharmaceutical ingredient is chosen from the group consisting of levonorgestrel, ethynyl estradiol, norethisterone, ethynodiol diacetate, desogestrel, lynestrenol, and mixtures thereof, it would have been prima facie obvious to one of ordinary skill at the time of filing to have at least one active pharmaceutical ingredient comprising in its chemical structure at least one terminal alkene, or at least one terminal alkyne in Bhatt’s method of controlling release of a drug from curable silicone liquid silicone rubber composition. Bhatt teaches drugs that may be released from the silicone rubber matrix are exemplified by hormonal agents such as estradiol (page 6, paragraph [0045]). One would have understood in view of Woolfson that contraceptives suitable for intravaginal release from the device body levonorgestrel, norethisterone, desogestrel, estradiol, and ethinyl estradiol (page 7, paragraph [0067]). It would have been obvious to one of ordinary skill in the art to have least one active pharmaceutical ingredient comprising in its chemical structure at least one terminal alkene, or at least one terminal alkyne in Bhatt’s method of controlling release of a drug from curable silicone liquid silicone rubber composition because Bhatt teaches drugs that may be released from the silicone rubber matrix are exemplified by hormonal agents such as estradiol (page 6, paragraph [0045]) and Woolfson that contraceptives suitable for intravaginal release from the device body such as estradiol, and ethinyl estradiol (page 7, paragraph [0067]), therefore ethinyl estradiol is obvious as an active pharmaceutical ingredient because Bhatt teaches the genus of estradiol and Woolfson teaches the species of estradiol as contraceptives which is ethinyl estradiol which has an terminal alkene. See MPEP 2144.08.
The examiner also points out that it would have been obvious to one of ordinary skill in the art to optimize the effect of hormonal agents in Bhatt’s method of controlling release of a drug from curable silicone liquid silicone rubber composition because Bhatt teaches drugs that may be released from the silicone rubber matrix are exemplified by hormonal agents (page 6, paragraph [0045]), and Woolfson teaches that contraceptives suitable for intravaginal release from the device body levonorgestrel, norethisterone, desogestrel, estradiol, and ethinyl estradiol (page 7, paragraph [0067]). One of ordinary skill in the art would have the understanding of optimizing how to apply the examples of hormonal agents taught by Woolfson to achieve desired results for example contraception.
It would have been prima facie obvious to one of ordinary skill in the art at the time of filing to have a fatty acid ester formed from an alcohol of 2 to 20 atoms, wherein said alcohol is an alkanol of 2 to 4 carbon atoms, wherein said fatty acid ester is isopropyl myristate in Bhatt’s method of controlling release of a drug from curable silicone liquid silicone rubber composition. Bhatt teaches release additives as an additional component which effects the release of the drug or active from the silicone rubber matrix may be added such as polyethylene glycols (page 5, paragraph [0040]). Woolfson teaches release enhancers such as fatty acid esters preferably myristate esters and polyethylene glycols; wherein the fatty acid esters preferably containing 2 to 20 carbon atoms, of which myristate esters are preferred (page 4, paragraph [0045]). One would have understood in view Muraoka that isopropyl myristate is a type of myristate ester (i.e., fatty acid ester) (column 5, lines 12-16). It would have been obvious to one of ordinary skill in art to have isopropyl myristate in Bhatt’s method of controlling release of a drug from curable silicone liquid silicone rubber composition because Bhatt teaches release additives and Woolfson teaches release enhancers such as fatty acid esters preferably myristate esters and Muraoka teaches that isopropyl myristate is a type of myristate ester. Therefore, isopropyl myristate is suitable in biomedicine as a myristate ester.
Response to Arguments
Applicants arguments filed 02/16/2026 have been fully considered but they are not persuasive.
On page 9 of Applicants remarks, Applicants argue that as taught in the specification, the curable liquid silicone rubber compositions were prepared by mixing the two components, Part-A and Part-B, and that Bhatt does not teach or suggest a curable liquid silicone rubber composition comprising a two component system and an API having terminal alkene, or alkyne functionalities as recited in amended claim 1. Applicants further argue that one skill in the art would find no motivation in Bhatt to arrive at the composition of the instant claims at least because Bhatt provides no teaching or suggestion of an API having terminal alkene or alkyne functionalities; a mixture comprising benzotriazole and at least one fatty acid ester; and a drug delivery device that is effective for the delivery of drugs comprising at least one terminal alkene, or terminal alkyne.
These arguments are not persuasive. With regards to the argument that Bhatt does not teach a curable liquid silicone rubber composition comprising a two component system, the Examiner points out that the preamble recites a curable liquid silicone rubber composition as a resulting of the mixing of the two component system. The fact that Applicants are describing the composition with its constituent parts is product by process because in order to claim the final product one must combine the two component system, whereas Applicants are claiming the final curable liquid silicon rubber composition. The final product taught in Bhatt is still a curable liquid silicone rubber composition reading to the final product instantly claimed.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). With regards to Applicants argument one skill in the art would find no motivation in Bhatt to arrive at the composition of the instant claims, the Examiner points out that Bhatt was relied on for the teaching of controlling release of active agents/drugs from a silicon rubber matrix wherein the silicon rubber matrixes are produced by curing a liquid silicone rubber comprised of (a) a polyorganosiloxane containing at least two alkenyl radicals per molecule; (b) an organohydrogensiloxane containing at least two silicon-bonded hydrogen atoms per molecule; and (c) a hydrosilylation catalyst in an amount sufficient to promote curing of said composition (page 2, paragraph [0008]). Bhatt also teaches wherein the polyorganosiloxane (a) must contain at least two silicon-bonded alkenyl radicals in each molecule. Suitable alkenyl radicals contain from 1 to 10 carbon atoms and are exemplified by vinyl (page 2, paragraph [0011]). Bhatt further teaches hydrosilylation catalysts useful in the instant invention are platinum metal, platinum compounds, platinum complexes and others such as rhodium compounds, nickel compounds, palladium metals (paragraph [0022]). Bhatt further teaches finely divided forms of silica are preferred reinforcing fillers. Colloidal silicas are particularly preferred (page 4, paragraph [0032]). Bhatt continues to teach drugs that may be released from the silicone rubber matrix are exemplified by hormonal agents such as estradiol (page 6, paragraph [0045]). Bhatt also teaches wherein the organohydrogensiloxane (b) is present in an amount sufficient to provide a molar ratio of alkenyl radicals in polyorganosiloxane (a) to silicon-bonded hydrogen atoms in the organohydrogensiloxane (b) of from 0.5:1 to 20:1 (page 9, claim 1). The examiner notes that the claimed range falls within the range of Bhatt. Bhatt further teaches platinum catalyst inhibitors such as acetylenic alcohols (i.e., “cure rate controller”) (page 4, paragraph [0027]). The examiner relied on Woolfson for the teaching of the specific API having a terminal alkene or alkyne functionalities and the use of fatty acid esters. The examiner relied on Blanda for the teaching of antifungal agents used in a intravaginal drug delivery device can be bifonazole, butoconazole, eberconazole, ketoconazole, tioconazole etc. (i.e., triazole compounds)(page 13, paragraph [0132]) which are capable of inhibiting or destroying the growth of a microbial organism (page 12, paragraph [0126]) and Agarwal teaches that antimicrobial actives can be selected from fluconazole, terconazole, itraconazole, and benzotriazole. It would have been obvious to use fatty acid ester in Bhatt’s method of controlling release of a drug from curable silicone liquid silicone rubber composition because Bhatt teaches release additions such as polyethylene glycols and Woolfson teaches release enhancers such as fatty acid esters preferably myristate esters and polyethylene glycols. Therefore, fatty acid esters preferably myristate esters would have been suitable for the purpose of a release additive in Bhatt’s composition. See MPEP 2144.07. Also Bhatt teaches drugs that may be released from the silicone rubber matrix are exemplified by hormonal agents such as estradiol (page 6, paragraph [0045]) and Woolfson that contraceptives suitable for intravaginal release from the device body such as estradiol, and ethinyl estradiol (page 7, paragraph [0067]), therefore ethinyl estradiol is obvious as an active pharmaceutical ingredient because Bhatt teaches the genus of estradiol and Woolfson teaches the species of estradiol as contraceptives which is ethinyl estradiol which has an terminal alkene. See MPEP 2144.08. It would have been obvious to one of ordinary skill in the art to have a benzotriazole in Bhatt’s method of controlling release of a drug from curable silicone liquid silicone rubber composition because Woolfson teaches an intravaginal drug delivery device comprising a curable liquid silicone that further comprises antifungals as a drug in the device and Blanda teaches antifungal agents used in a intravaginal drug delivery device can be bifonazole, butoconazole, eberconazole, ketoconazole, tioconazole etc. (i.e., triazole compounds)(page 13, paragraph [0132]) which are capable of inhibiting or destroying the growth of a microbial organism (page 12, paragraph [0126]) and Agarwal teaches that antimicrobial actives can be selected from fluconazole, terconazole, itraconazole, and benzotriazole. Therefore, benzotriazole was known to serve the same purpose of an antimicrobial agent in the form of a triazole compound. See MPEP 2144.06 (II).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AFUA BAMFOAA BOATENG whose telephone number is (703)756-1358. The examiner can normally be reached Monday - Friday 9:00am - 5:00pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached on (571) 272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
AFUA BAMFOAA BOATENGExaminer, Art Unit 1617
/ALI SOROUSH/Supervisory Patent Examiner, Art Unit 1614