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 .
Detailed Action
Status of Application
1. Applicants’ arguments/remarks filed 26 February 2026 are acknowledged. Claims 1-2, 5, 7-8, 11-12, and 17-27 are currently pending. Claims 3-4, 6, 9-10, and 13-16 have been cancelled. Claim 24 has been amended. Claims 26-27 are newly added. Claims 1-2, 5, 7-8, 11-12, and 17-27 are examined on the merits within.
Maintained/New Rejections
Claim Rejections – 35 U.S.C. 102
2. The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
3. Claim(s) 1-2, 5, 17-22, and 25-27 is/are again rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yu et al. (U.S. Patent Application Publication No. 2013/0078209).
Regarding instant claims 1-2, 5, 17-22, and 25, Yu et al. disclose compositions for treating conditions of compromised skin barrier function. See abstract. The composition comprises a) reactive reinforcing component and b) a cross-linking component that facilitates in situ crosslinking of the reactive reinforcing component. See claim 21. In some embodiments, the reactive reinforcing component comprises a reactive constituent and a reinforcing constituent. See paragraph [0097]. The reactive constituent comprises at least one organopolysiloxane (component b) and at least one hydride functionalized polysiloxane (component c). See paragraph [0098]. In some embodiments, high viscosity organopolysiloxane and the low-viscosity organopolysiloxane are selected from the group consisting of vinyl terminated polydimethylsiloxane; vinyl terminated diphenylsiloxane-dimethylsiloxane copolymers; vinyl terminated polyphenylmethylsiloxane, vinylphenylmethyl terminated vinylphenylsiloxane-phenylmethylsiloxane copolymer; vinyl terminated trifluoropropylmethylsiloxane-dimethylsiloxane copolymer; vinyl terminated diethylsiloxane-dimethylsiloxane copolymer; vinylmethylsiloxane-dimethylsiloxane copolymer, trimethylsiloxy terminated; vinylmethylsiloxane-dimethylsiloxane copolymers, silanol terminated; vinylmethylsiloxane-dimethylsiloxane copolymers, vinyl terminated; vinyl gums; vinylmethylsiloxane homopolymers; vinyl T-structure polymers; monovinyl terminated polydimethylsiloxanes; vinylmethylsiloxane terpolymers; vinylmethoxysilane homopolymers and combinations thereof. See paragraph [0101]. These compounds overlap with those cited in the instant specification and thus should have the same viscosity. See paragraph [0041]. The hydride functionalized polysiloxane can be hydride terminated polydimethylsiloxane; polyphenyl-(dimethylhydrosiloxy)siloxane, hydride terminated; methylhydrosiloxane-phenylmethylsiloxane copolymer, hydride terminated; methylhydrosiloxane-dimethylsiloxane copolymers, trimethylsiloxy terminated; polymethylhydrosiloxanes, trimethylsiloxy terminated; polyethylhydrosiloxane, triethylsiloxane, methylhydrosiloxane-phenyloctylmethylsiloxane copolymer; methylhydrosiloxane-phenyloctylmethylsiloxane terpolymer and combinations thereof. See paragraph [0101]. These polymers overlap with the components listed as hydride functionalized polysiloxane in the instant specification. See paragraph [0041]. Thus the viscosity should be the same. The crosslinking component comprises a platinum catalyst (component a). See paragraphs [0104-0105]. The catalyst stabilizer may be a vinyl-substituted cyclic or linear siloxane such as tetravinyl tetramethylcyclotetrasiloxane, divinyltetramethyldisiloxane, trivinylpentamethyltrisiloxane, or divinyltetraethoxydislioxane (component d). See paragraph [0107]. Since Yu et al. disclose the same combination of ingredients they should function in the same manner, i.e., stored together without significant crosslinking, lowered rate of cross-linking reaction, room temperature vulcanization, dissociation, and complex formation. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). The molar ratio of catalyst to stabilizer is 0.1 to 10. See paragraph [0107]. This equates to a 100:1 ratio of stabilizer (ligand) to catalyst.
Thus the instant claims are anticipated by Yu et al.
Claim Rejections – 35 U.S.C. 103
4. 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.
5. Claim(s) 1-2, 5, 7-8, 11-12, and 17-27 is/are again rejected under 35 U.S.C. 103 as being unpatentable over Yu et al. (U.S. Patent Application Publication No. 20130078209) in view of Lee et al. (U.S. Patent No. 4,766,176).
Regarding instant claims 1-2, 5, 17-22, and 25, Yu et al. teach compositions for treating conditions of compromised skin barrier function. See abstract. The composition comprises a) reactive reinforcing component and b) a cross-linking component that facilitates in situ crosslinking of the reactive reinforcing component. See claim 21. In some embodiments, the reactive reinforcing component comprises a reactive constituent and a reinforcing constituent. See paragraph [0097]. The reactive constituent comprises at least one organopolysiloxane (component b) and at least one hydride functionalized polysiloxane (component c). See paragraph [0098]. In some embodiments, high viscosity organopolysiloxane and the low-viscosity organopolysiloxane are selected from the group consisting of vinyl terminated polydimethylsiloxane; vinyl terminated diphenylsiloxane-dimethylsiloxane copolymers; vinyl terminated polyphenylmethylsiloxane, vinylphenylmethyl terminated vinylphenylsiloxane-phenylmethylsiloxane copolymer; vinyl terminated trifluoropropylmethylsiloxane-dimethylsiloxane copolymer; vinyl terminated diethylsiloxane-dimethylsiloxane copolymer; vinylmethylsiloxane-dimethylsiloxane copolymer, trimethylsiloxy terminated; vinylmethylsiloxane-dimethylsiloxane copolymers, silanol terminated; vinylmethylsiloxane-dimethylsiloxane copolymers, vinyl terminated; vinyl gums; vinylmethylsiloxane homopolymers; vinyl T-structure polymers; monovinyl terminated polydimethylsiloxanes; vinylmethylsiloxane terpolymers; vinylmethoxysilane homopolymers and combinations thereof. See paragraph [0101]. These compounds overlap with those cited in the instant specification and thus should have the same viscosity. See paragraph [0041]. The hydride functionalized polysiloxane can be hydride terminated polydimethylsiloxane; polyphenyl-(dimethylhydrosiloxy)siloxane, hydride terminated; methylhydrosiloxane-phenylmethylsiloxane copolymer, hydride terminated; methylhydrosiloxane-dimethylsiloxane copolymers, trimethylsiloxy terminated; polymethylhydrosiloxanes, trimethylsiloxy terminated; polyethylhydrosiloxane, triethylsiloxane, methylhydrosiloxane-phenyloctylmethylsiloxane copolymer; methylhydrosiloxane-phenyloctylmethylsiloxane terpolymer and combinations thereof. See paragraph [0101]. These polymers overlap with the components listed as hydride functionalized polysiloxane in the instant specification. See paragraph [0041]. Thus the viscosity should be the same. The crosslinking component comprises a platinum catalyst (component a). See paragraphs [0104-0105]. The catalyst stabilizer may be a vinyl-substituted cyclic or linear siloxane such as tetravinyl tetramethylcyclotetrasiloxane, divinyltetramethyldisiloxane, trivinylpentamethyltrisiloxane, or divinyltetraethoxydislioxane (component d). See paragraph [0107]. Since Yu et al. teach the same combination of ingredients they should function in the same manner, i.e., stored together without significant crosslinking, lowered rate of cross-linking reaction, room temperature vulcanization, dissociation, and complex formation. The molar ratio of catalyst to stabilizer is 0.1 to 10. See paragraph [0107]. This equates to a 100:1 ratio of stabilizer (ligand) to catalyst.
Yu et al. do not teach microcapsules.
Lee teaches storage stable organosiloxane compositions that cure upon heating by a platinum-catalyzed hydrosilation reaction, wherein the composition comprises organosiloxane reactants, a platinum-containing hydrosilation catalyst that is microencapsulated within one or two layers of thermoplastic organic polymers (abstract). In particular, Lee teaches (A) a curable polyorganosiloxane containing at least two ethylenically unsaturated hydrocarbon radicals per molecule, (B) an organohydrogen siloxane containing at least two silicon bonded hydrogen atoms per molecule in an amount sufficient to achieve curing of said polyorganosiloxane (A), where the sum of the average number of ethylenically unsaturated hydrocarbon radicals per molecule of (A) and the average number of silicon bonded hydrogen atoms per molecule of said organohydrogen siloxane (B) is greater than 4, and (C) an amount of a platinum-containing hydrosilation catalyst sufficient to promote curing of said composition at temperature of at least 70°C and above. The components A and B of Lee read on instant components b) and c) respectively. Lee teaches that the improvement comprises the presence of the platinum-containing catalyst in the form of microcapsules that, in turn, comprise said catalyst as finely divided particles or droplets that are completely enveloped within one or two layers of a thermoplastic organic polymer (col. 4,1 15-40). Lee further teaches that the microencapsulated catalyst is prepared by reacting hexachloroplatinic acid and tetramethyl divinyldisiloxane and diluting the reaction product with a liquid dimethylvinylsiloxy terminated polydimethylsiloxane (example 1).Lee teaches that the catalyst is effectively isolated from the other ingredients of the composition until the composition is heated to the melting or softening point of the thermoplastic polymer(s) surrounding the catalyst, the compositions are stable for extended periods of time, typically several months or longer, under ambient conditions, yet cure relatively rapidly at temperatures above the melting or softening point of the thermoplastic polymer(s). With respect to claim 24, Lee teaches microcapsules made of polymethyl methacrylate or cellulose esters (i.e., polysaccharides) (example 3 and column 5, lines 31-41).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the composition of Yu et al. to include the platinum catalyst in microcapsules to prevent crosslinking until time of use. One would have been motivated with a reasonable expectation of success to keep the ingredients separated until crosslinking is desired and provide a stable composition. With respect to claim 23, Lee does not state that the microcapsules dissociate from the catalyst at the claimed temperature or under acoustic wave or electromagnetic wave. However, the combined teachings of Yu et al. and Lee renders the claimed composition obvious. Thus, one of an ordinary skill in the art, before the effective filing date of the instant invention, would have expected that the composition of Yu et al. modified with Lee provides the claimed dissociation. It would have been well within the purview of the skilled artisan to modify the ratio of catalyst to ligand to control the rate of the reaction to achieve the desired effect in an optimal time frame.
Response to Arguments
Applicant's arguments filed 26 February 2026 have been fully considered but they are not persuasive.
6. Applicants argued, “One of skill in the art would understand the cross-linking component of Yu facilitates rather than slows down the cross-linking reaction. The Examiner has not pointed to any formulation that uses the catalyst stabilizer to slow down cross-linking.”
In response to applicants’ arguments, claim 1 recites “A method for treating a dermatological disorder in a subject in need thereof, comprising: applying to the subject a composition comprising a) a reactive reinforcing component; and b) a cross-linking component; wherein said cross-linking component facilitates in situ cross-linking of the reactive reinforcing component, such that a film is formed on skin, thereby treating the dermatological disorder.” Thus the composition, i.e., the combination of ingredients, are applied to the skin and after application a film is formed by in situ cross-linking. Thus cross-linking does not occur during storage but after application to the skin. Slowing down crosslinking is a function the compound. Yu teaches the addition of the same compound, i.e., a divinyldisiloxane as cited in claim 5, and thus should function in the same manner. Since Yu teaches a combination of at least one transition metal catalyst, at least one unsaturated organopolymer, at least on hydride functionalized polysiloxane and a divinyldisiloxane, the formulation should function in the same manner devoid of evidence to the contrary. If the composition does not function in the same manner, do the claims lack a component essential for the property to be achieved?
Thus this rejection is maintained.
7. Applicants argued, “Lee states that even if the composition contains one or more of the known platinum catalysts inhibitors, it cannot be stored in a single container for more than a few hours. One would not be motivated to add microcapsules of Lee to the crosslinking component of Yu because doing so would make the formulations of Yu unsatisfactory for its intended purpose of facilitating in situ cross-linking. Yu and Lee do not state the specific combination of viscosities. Lee and Yu use polymers of different viscosities and there is no evidence showing that microcapsules of Lee can be applied to compositions of Yu. Lee does not describe microcapsules comprising hydride organopolysiloxane.”
In response to applicant’s arguments that platinum catalyst inhibitors cannot be stored in a single container for more than a few hours, Lee mentions that one way to avoid the inherent disadvantage of catalyst compositions is to completely microencapsulate finely divided particles of a catalyst composition within a material that is impermeable to the catalyst and effectively isolates it from the reactive ingredients of a curable organosiloxane composition. See column 2, lines 36-45. This provides motivation to encapsulate the catalyst for storage purposes, especially since in situ crosslinking occurs during application to the skin. It would have been obvious to modify the composition of Yu et al. to include the platinum catalyst in microcapsules to prevent crosslinking until time of use. One would have been motivated with a reasonable expectation of success to keep the ingredients separated until crosslinking is desired and provide a stable composition. Lee teaches the same microcapsule material as instantly claimed, i.e., polysaccharide. This material separates the catalyst to increase stability. Thus the combination of references make obvious the claimed invention and should behave in the same manner. Lee does not teach specific viscosities but does teach the same type of ingredients ((A) a curable polyorganosiloxane containing at least two ethylenically unsaturated hydrocarbon radicals per molecule, (B) an organohydrogen siloxane containing at least two silicon bonded hydrogen atoms per molecule, wherein A and B read on components B and C of the instant claim, and thus there should be a reasonable expectation of success when microencapsulating the platinum catalyst. The polymers of Yu et al. overlap with the components listed as hydride functionalized polysiloxane in the instant specification. See paragraph [0041]. Thus the viscosity should be the same.
Thus this rejection is maintained.
Conclusion
8. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Correspondence
9. No claims are allowed at this time.
10. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JESSICA WORSHAM whose telephone number is (571)270-7434. The examiner can normally be reached Monday-Friday (8-5).
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/JESSICA WORSHAM/Primary Examiner, Art Unit 1615
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