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 .
Election/Restrictions
Applicant's election with traverse of Group I and the additive species to be a nonionic surfactant with an HLB of 5-9 in the reply filed on 07/27/2026 is acknowledged. The traversal for the restriction is on the ground(s) that claim 1 from Group I, claim 18 from Group II, and claim 19 from Group III share a common technical feature of a composition comprising salicylic acid, a silicone containing film-forming polymer, a silicate tackifying resin, and an additive comprising (i) a nonionic surfactant having an HLB of 5-9, (ii) an aminosilicone having an amine value greater than 60, (iii) a cationic silicone polyquaternium, or (iv) combinations thereof; and the presence of a volatile solvent in claim 18 is a manufacturing/process feature for making the gel composition and does not remove the common technical relationship among the claimed composition, method of making the composition, and method of using the composition. Applicant also asserts that Wiedersberg et al. is to a transdermal therapeutic system to a scopolamine transdermal dry delivery patch and not a film-forming salicylic acid treatment article or gel composition with the silicone containing film forming polymer, silicate tackifying resin, and claimed additive; and that Som et al. lists examples of surfactants used as penetration enhancers for transdermal delivery but does not teach the claimed salicyclic acid film forming composition; not that the two references do not teach or suggest the claimed combination.
This is fully considered but not persuasive because contrary to Applicant’s assertion - the claimed inventions require different components as addressed in the prior action as Group II (i.e. claim 18 is a method of making that requires the presence of the violate solvent wherein neither Group I or Group III require it, and Group II requires that the composition must be a gel which is not a required form for Group I or Group III which are open to any composition form. Therein the claims are not unified by a common technical feature. As for the assertion that Wiedersberg et al. is to a transdermal therapeutic system to a scopolamine transdermal drug delivery patch and not a film-forming salicylic acid treatment article or gel composition with the silicone containing film forming polymer, silicate tackifying resin, and claimed additive; this is not persuasive as the claims such as claim 1 of Group I or claim 19 of Group III do not require the composition to be a gel and are open to any composition form and are open language (“comprising”) wherein it can contain any components to any form in addition to the salicylic acid, a silicone containing film-forming polymer, a silicate tackifying resin, and a recited additive; such as the inclusion of scopolamine and a transdermal patch. Wiedersberg et al. teaches the recited silicone hybrid polymer which is a silicon polymer that can be a combination of silicone polymer and a silicone resin (i.e. silicone containing film forming polymer and silicate tackifying resin), silicone based pressure-sensitive adhesives, and at least one additive like permeation enhancers like salicylic acid, solubilizers, and tackifiers (silicon resin tackifier like dimethylpolysiloxanes); and Som et al. establishes known penetration enhancers wherein the assertion that the two references teach or suggest the claimed combination is not persuasive as the inclusion of known nonionic surfactants that are permeation enhancers for their known purposes and additive effect is prima facie obvious with a reasonable expectation of success. Applicant’s argument that Som et al. is to surfactants used as penetration enhancers for transdermal delivery but does not teach the claimed salicyclic acid film forming composition; is against the reference individually and 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).
Applicant also traverses the election of species asserting that the generic claim sufficiently includes few species where it is traversed on the grounds for meeting burden. This is not found persuasive because the instant case is submitted under 35 U.S.C. 371, the Unity of Invention practice in MPEP §1850 and MPEP §1893.03(d) was followed, not restriction/species/burden practice. Thus the criteria for burden under 35 U.S.C. 111(a) does not apply (MPEP §801). The lack of unity has been addressed in the previous action. As the species do not share a common chemical core or technical feature and have different chemical cores and structures the species election is proper.
The requirement is still deemed proper and is therefore made FINAL.
Status of Application
Applicant has elected Group I in response to restriction requirement and for the examination.
Due to restriction, based on election of Group I and the species election for the additive to be a nonionic surfactant with an HLB of 5-9, claims 6-8, 18-19 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Claims 1-19 are pending.
Claims 1-5, 9-17 are present for examination at this time.
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.
Claims 1-5, 9-17 are rejected under 35 U.S.C. 103 as being unpatentable over Wiedersberg et al. (U.S. Pat. Pub. 2021/0145760) in view of Som et al. (Status of surfactants as penetration enhancers in transdermal drug delivery).
Rejection:
Wiedersberg et al. teaches a composition (transdermal therapeutic system) comprising a silicone hybrid polymer such as a silicone based pressure-sensitive adhesives which is a silicon polymer that can be a combination of silicone polymer and a silicone resin (i.e. silicone containing film forming polymer and silicate tackifying resin), scopolamine, filler, and at least one additive like permeation enhancers like salicylic acid, solubilizers, and tackifiers (silicon resin tackifier like dimethylpolysiloxanes, silicone resin tackifier, abstract, [38, 58-67, 108-123, 182-195, 300, 306-309]). The silicone based pressure-sensitive adhesives can also have a silicone polymer with at least one polydiorganosiloxane that can also be preferably end-capped [250]. The pressure-sensitive adhesives based on polysiloxanes have suitable tack and bonding for various skin types including wet skin and the polysiloxane can have residual silanol functionality that is capped with trimethylsiloxy groups is polyvinylsiloxane content ([281-282] a known MQ tackifier resin-see Rawsource- what is the tackifier in a silicone pressure-sensitive adhesive?). The amount of additive like permeation enhancers/solubilizers such as salicylic acid is from 1-30% [35, 306-308], and the silicone acrylic hybrid polymer (i.e. silicone containing film forming polymer and silicate tackifying resin) can be from 90-98%wt [35]. The fillers include silica gels, titanium dioxide and zinc oxide that can be used to influence certain physical parameter such as bond strength and cohesion (thickener/coagulant) [309]. The composition can also be in a volatile solvent like ethanol [341] where the drug matrix silicone adhesive layer/coating is made by combining the components together wherein the solids are from 30-80% (i.e. polymers, wherein the solvent is then 20-70%) prior to placement on a backing layer ([63, 69, 105, 168], see full document specifically areas cited).
While Wiedersberg et al. does not teach the exact claimed values for the amount of penetration enhancer/solubilizer, silicone based pressure-sensitive adhesives (the combination of silicone containing film forming polymer and silicate tackifying resin), or solvent; they are either embraced within the taught ranges wherein it is prima facie obvious to optimize within the taught ranges or they overlap wherein even a slight overlap in ranges establishes a prima facie case of obviousness as a means to attain the desired therapeutic profile with a reasonable expectation of success absent evidence of criticality.
Conclusion
Claims 1-5, 9-17 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GIGI GEORGIANA HUANG whose telephone number is (571)272-9073. The examiner can normally be reached Monday-Thursday 9:00-5:00pm.
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/GIGI G HUANG/Primary Examiner, Art Unit 1613
