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 .
Claim Objections
Claim 15 is objected to because of the following informalities: the claim recites “the release layer”, but there is no previous recitation of “release layer” in the claim. The initial recitation of such a component should be as “a release layer”. Appropriate correction is required.
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 1-9 and 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over Ito (US PGPub No. 2012/022303 – see IDS) in view of Vepachedu (US PGPub No. 20208/0261442 – see IDS) as evidenced by Chono et al. (US PGPub No. 2004/0142024).
Ito teaches a percutaneous absorption preparation for treating dementia composed of a drug containing a layer, a support, and cover/liner layer (see abstract, paragraph 65, and example 1). The dementia drug is envisioned as memantine that may be in an addition salt form at 0.5 to 20 mass% (see paragraphs 28-30; instant claims 1-2). The composition also includes a styrenic polymer compound and tackifier (plasticizer), as well as a fatty acid alkyl ester (solubilizer) (see paragraph 21; instant claim 14). The preferred styrenic polymer is a styrene-isoprene-styrene block copolymer (pressure sensitive adhesive) that is present at 5 to 90 mass% (see paragraphs 41-42; instant claims 7-9). The preferred fatty acid alkyl ester (solubilizer) is isopropyl myristate present at 1 to 20 mass% (see paragraphs 38-40; instant claims 4-6). An example combines 5 mass% dementia treating drug, 15 mass% isopropyl myristate, 21.15 mass%, styrene-isoprene-styrene block copolymer, and triethyl citrate (plasticizer) into a drug containing layer composition of the percutaneous absorption preparation (see example 1; Chono et al. paragraph 28). Preparation of the percutaneous absorption preparation occurs via combination of its components with a solvent, envisioned as toluene, n-hexane, ethyl acetate, tetrahydrofuran methanol, or ethanol, to form a plaster solution which implies dissolving the percutaneous absorption preparation components in the solvent (see paragraph 74; instant claims 15-16). Ito teaches applying the plaster solution to a liner/release layer, drying the solvent, and laminating a support to the opposite side of the percutaneous absorption preparation (see example 1; instant claim 17). An enanthate salt of memantine is not explicitly detailed.
Vepachedu teaches various acid addition salts for memantine that may be employed to treat dementia (see paragraph 3 and claims 1-3). Enanthate is named amongst the named salts (see claim 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the percutaneous drug delivery layer with a liner and support on either side of Ito, with memantine, styrene-isoprene-styrene block copolymer, isopropyl myristate, and a plasticizer. These choices would have been obvious due to their explicit combination in example 1 or due to their being preferred options for the drug, styrenic polymer, and fatty acid alkyl ester (solubilizer). The application of the taught proportions would follow and meet or yields overlapping ranges with the instantly claimed ranges, thereby rendering the instantly claimed ranges obvious. “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed.Cir. 1990)” (see MPEP 2144.05). It additionally would have been obvious to make the layered construct as Ito suggests, where a solution of the percutaneous absorption preparation is made employing an envisioned solvent and combined with a release and liner layer. Therefore claims 1-9 and 14-16 are obvious over Ito in view of Vepachedu as evidenced by Chono et al.
Claims 1-16 are rejected under 35 U.S.C. 103 as being unpatentable over Terehara et al. (US PGPub No. 2004/0258741) in view of Ito and Vepachedu.
Terehara et al. teach a percutaneous absorption preparation for treating dementia composed of an adhesive drug containing a layer, a support, and cover/liner/release layer (see abstract, paragraph 34, and claim 1). The adhesive layer includes a hydrophobic polymer, absorption promoting agent, and may also include a plasticizer (see paragraphs 9, 17, 22, and 54; instant claim 14). The hydrophobic polymer is envisioned as polyisobutylene, styrene-isoprene-styrene block copolymer, or a (meth)acrylic polymer that is present at 5 to 90 wt% (see paragraphs 17-21 and 47; instant claims 7-13). The absorption promoting agent is envisioned as propylene glycol monolaurate and isopropyl myristate present at 0.01 to 20 wt% (see paragraphs 52-53; instant claims 4-6). Preparation of the adhesive layer occurs via by dissolving its components in a solvent, envisioned as toluene, hexane, or ethyl acetate that is then spread on a release paper, dried, and laminated to a support (see paragraph 60; instant claim 17). An enanthate salt of memantine is not explicitly detailed.
Ito teaches a percutaneous absorption preparation for treating dementia composed of a drug containing a layer, a support, and cover/liner/release layer (see abstract, paragraph 65, and example 1). The dementia drug is envisioned as memantine that may be present in an addition salt form at 0.5 to 20 mass% (see paragraphs 28-30; instant claims 1-2).
Vepachedu teaches various acid addition salts for memantine that may be employed to treat dementia (see paragraph 3 and claims 1-3). Enanthate is named amongst the named salts (see claim 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the percutaneous drug delivery layer with a liner and support on either side of Terehara et al. with memantine as the dementia treating drug, in light of Ito because they detail its delivery percutaneously via a similar preparation. This modification would have been obvious as the simple substitution of one known element for another in order to yield a predictable outcome. It additionally would have been obvious to select a hydrophobic polymer and solubilizing agent envisioned by Terehara et al., namely propylene glycol monolaurate or isopropyl myristate in combination with polyisobutylene, styrene-isoprene-styrene block copolymer, or a (meth)acrylic polymer, and a plasticizer. These choices would have been obvious due to their suggestion. The application of the taught proportions for memantine, hydrophobic polymer, and solubilizing agent would follow and yields overlapping ranges with the instantly claimed ranges, thereby rendering the instantly claimed ranges obvious (see MPEP 2144.05). It additionally would have been obvious to make the layered construct as Terehara et al. suggest, where a solution of the adhesive layer is made employing an envisioned solvent and combined with a release and liner layer. Therefore claims 1-16 are obvious over Terehara et al. in view of Ito and Vepachedu.
Conclusion
No claim is allowed.
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/CARALYNNE E HELM/Examiner, Art Unit 1615