Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined pursuant to the first inventor to file provisions of the AIA .
DETAILED ACTION
Status of the Claims
Applicant filed claims 1 – 11 with the instant application on 15 November 2022. In a Preliminary Amendment filed on the same day, Applicant amended claims 3 – 7, and added new claims 12 – 20. Currently, claims 1 – 20 are available for substantive examination.
Response to Requirement for Election of Species
The Examiner acknowledges Applicant’s election of the species tributyl citrate, with traverse, from the genus of citric acid esters. Applicant traverses on the basis that the invention as claimed is directed to a “medical plaster,” but the references cited to break unity of invention in the Action of 28 August 2025 are directed to transdermal patches. Applicant contends that medical plasters are designed to affect only the area around the point of application (local delivery) while transdermal patches are designed to provide systemic delivery (into the bloodstream) of active ingredients. Although not taking issue with Applicant’s characterization of the invention, the species election requirement is based on the claims as written. The preamble to claim 1 recites a “medical plaster,” but the invention as claimed meets the definition of a composition of matter, and is being examined consistent with that statutory category of invention (see discussion below).
Thus, its subject matter must be distinguished from the prior art by its structure or composition. Cf. Hewlett- Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1468 (Fed. Cir. 1990) (holding that “apparatus claims cover what a device is, not what a device does.’’). Statements of intended use or function normally are not given patentable weight because they are not structurally limiting. Cf Cochlear Bone Anchored Sols. AB v. Oticon Med. AB, 958 F.3d 1348, 1354-55 (Fed. Cir. 2020) (discussing effect of intended use recitations in claim preamble).
Consequently, in light of the above discussion, Applicant’s arguments are not persuasive and claims 1 – 20 are available for substantive examination to the extent that the ester of citric acid is tributyl citrate, to which the following rejections apply.
Information Disclosure Statement
The Examiner has considered the Information Disclosure Statements (IDS’s) filed 15 November 2022 and 19 April 2024, which are now of record in the file.
Priority
The Examiner acknowledges receipt of papers submitted pursuant to 35 U.S.C. §§ 119(a)-(d), which papers are now of record in the file.
Claim Interpretation
Claims 1 and 8 recite the following: “comprising or consisting of,” with respect to the components of the compositions of the invention. However, the transitional phrase, “comprising,” is considered to be open-ended, while the phrase, “consisting of,” is considered to be a closed term (see MPEP § 2111.023). Consequently, the claim is reasonably interpreted to present the two transitional terms in the alternative. The claims at issue are being examined on the basis of the open-ended “comprising” transitional term.
The preamble to claim 1 recites that the composition of the invention is a “medical plaster.” In this regard, the Examiner first notes that the invention as claimed is directed to the statutory category of “composition of matter.” Consequently, as cited above, the claimed subject matter must be distinguished from the prior art by its structure or composition. Cf. Hewlett- Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1468 (Fed. Cir. 1990), and not by what it does.
Applicant’s specification, at p. 1, ll. 25 – 27, states that “[w]ithin the generic category of adhesive release systems described above, transdermal patches and medical plasters can be distinguished, defined in international pharmacopoeias, as distinct pharmaceutical forms.” However, the specification’s disclosures relating to the definitions of patch and plaster do not address any specific structural or compositional factors that directly correlate to the mechanisms of action – local or systemic. The Examiner would further note that neither does claim 1 recite any limitations that could be interpreted as resulting in a local effect rather than a systemic effect.
The Examiner also notes that Applicant’s specification cites to Cilurzo WO ‘256 as describing a “medical plaster” with a diclofenac salt in a matrix of EUDRAGIT® NE40, further comprising an ester of citric acid as a plasticizer. However, the cited reference does not describe the disclosed dosage form as a ”medical plaster,” but rather as a “patch,” which term those of skill in the relevant art routinely apply to transdermal delivery devices.
The specification also cites to the European Pharmacopoeia’s definition of a transdermal patch. These definitions differ in the manner of action of the devices once applied to a patient’s skin, the transdermal patch being designed to deliver an active ingredient into the patient’s bloodstream to create a systemic effect, while a medical plaster is designed to act locally and not to produce a systemic effect.
Furthermore, Applicant’s specification distinguishes between Cilurzo WO ‘256 and the present invention on the basis of the salts of diclofenac in the claimed plaster (diclofenac sodium) and the patch of Cilurzo WO ‘256 (diclofenac diethylammonium), disclosing that the diethylammonium salt was chosen because it can provide a constant release over 24 hours which the sodium salt is not capable of achieving. Of particular relevance to this point is a further disclosure at p. 9, lines 14 – 18 of the specification:
The Applicant has however surprisingly discovered that the addition to the matrix described above of minimal quantities of butylhydroxyanisole (BHA) significantly modifies its properties, allowing the DicloNa [diclofenac sodium] dispersed therein to be released in a constant, continuous, prolonged manner, at locally therapeutically active doses for a duration of 24 hours.
Thus, Applicant’s specification appears to be relying on the inclusion of BHA, a compositional characteristic, as being responsible for the release profile that Cilurzo WO ‘256 could not achieve with diclofenac sodium, and not to “patch” vs. “plaster.” Consequently, the instant claims are being examined on the basis that the terms “plaster” and “patch” are interchangeable in the absence of any structural or compositional characteristics that would support a patentable distinction between the two terms.
Rejections Pursuant to 35 U.S.C. § 103
The following is a quotation of 35 U.S.C. § 103 that 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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 absent any evidence to the contrary. Applicants are advised of the obligation pursuant to 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 – 20 are rejected pursuant to 35 U.S.C. § 103, as being obvious over US 2015/0202171 A1 to Hatanaka, E., et al., published 23 July 2015, (“Hatanaka ‘171”), in view of WO 2012/089256 A1 to Cilurzo, F. and P. Minghetti, published 5 July 2012 (“Cilurzo WO ‘256”), and US 2006/0134095 A1 to Ito, S. and K. Matsubayashi, published 22 June 2006 (“Ito ‘095”).
The Invention As Claimed
Applicant claims a medical plaster comprising a base layer (backing), a "Pressure Sensitive Adhesive" (PSA) matrix, a protective coating layer (liner), wherein the PSA matrix comprises a neutral copolymer based on ethyl acrylate and methyl methacrylate in a 2:1 ratio, in a concentration ranging from 40 to 49%, or 45 – 48%, or 46.3%, by dry weight with respect to the dry weight of the matrix, tributyl citrate as a plasticizing agent, in a concentration ranging from 40 to 49%, or 45 – 48%, or 46.3%, by weight with respect to the dry weight of the matrix, butylhydroxyanisole (BHA) in a concentration ranging from 0.10 to 0.20%, or 0.13 – 0.18%, or 0.15%, by weight with respect to the dry weight of the matrix, and, dispersed in the PSA matrix, diclofenac sodium as an active ingredient, in a concentration ranging from 1 to 20%, or 5 – 10%, or 7.25%, by weight with respect to the dry weight of the matrix, wherein the base layer (backing) consists of a non-perforated 100% polyester non-woven fabric, and wherein the protective coating layer (liner) is a protective sheet of monosilicone paper.
The Teachings of the Cited Art
Hatanaka ‘171 discloses a patch comprising a support layer and an adhesive layer comprising diclofenac sodium, and permeation enhancers (see Abstract), wherein the diclofenac sodium is present at from 1 to 20% wgt relative to the total mass of the adhesive layer (see ¶[0029]), wherein a permeation enhancer comprises a salt of citric acid (see ¶[0032]), wherein the adhesive matrix comprises a pressure-sensitive adhesive at from 10 – 45% wgt (see ¶[0039]), wherein the adhesive comprises methyl methacrylate, butyl (meth)acrylate, hydroxyethyl (meth)acrylate, and the like (see ¶[0040]), wherein the adhesive layer comprises a plasticizer, such as an ester of a dibasic acid (see ¶[0043]), at 7 – 70% wgt (see ¶[0044]), wherein the adhesive layer can further comprise an antioxidant, such as butylhydroxyanisole (BHA) (see ¶[0045]), wherein the patch comprises a support [base] layer of non-woven polyester (see ¶[0047]), and wherein the patch also comprises a release [protective] liner layer made of a paper laminate that has been subjected to a silicone treatment) (see ¶[0048]). The reference does not disclose a PSA matrix that comprises a copolymer of ethylacrylate and methylmethacrylate (2:1) at 40 – 49% wgt, or a PSA matrix comprising tributyl citrate present at 40 – 49% wgt, or a PSA matrix wherein the BHA is present at 0.10 – 0.20% wgt. The teachings of Cilurzo WO ‘256 and Ito ‘095 remedy those deficiencies.
Cilurzo WO ‘256 discloses a medicated patch for improved transdermal penetration of a diclofenac salt in a composition comprising an acrylic polymer and a citric acid ester (see Abstract), wherein the patch comprises from 39 – 55% of an acrylic polymer, from 4 – 12% of the diclofenac salt, and from 42 – 55% of a citric acid ester, based on the total weight of the composition (see p. 1, ll. 14 – 18), wherein the citric acid ester is tributyl citrate (see EXAMPLE 4), and the acrylic polymer comprises a copolymer of ethylacrylate and methylmethacrylate [EUDRAGIT® NE 40] (see p. 1, ll. 19 – 20; see also, p. 2, ll. 8 - 9).
Ito ‘095 discloses a formulated skin preparation for external use or an antioxidative composition (see Abstract), wherein the composition is for external use and comprises butylhydroxyanisole as an antioxidative component (see ¶[0026]; see also, ¶[0114]), wherein the antioxidative component is present at 0.001 to 10% wgt (see ¶[0030]), wherein the composition further comprises diclofenac sodium (see ¶[0031]), wherein the external composition for the skin can be in any form suitable for an external preparation including a water-soluble preparation, an ointment, an emulsion, a cream, a gel, a facial mask, a bath preparation, a cleansing agent, a cataplasm, a dispersion liquid and the like, or a solid, paste, mousse, gel, powder, a solution system, a solubilization system, an emulsification system, a powder dispersion system, or a multilayer form (see ¶[0076]), and wherein the diclofenac sodium is present in an amount of from 0.001 to 10% wgt (see ¶[0113]; see also, ¶[0121]).
Application of the Cited Art to the Claims
It would have been prima facie obvious before the filing date of the claimed invention to prepare a patch comprising a support layer and an adhesive layer comprising diclofenac sodium, and permeation enhancers, wherein the diclofenac sodium is present at from 1 to 20% wgt relative to the total mass of the adhesive layer, wherein the adhesive matrix comprises a pressure-sensitive acrylate adhesive, at from 10 – 45% wgt, wherein the adhesive layer comprises a plasticizer, such as an ester of a dibasic acid, at 7 – 70% wgt, wherein the patch comprises a support [base] layer of non-woven polyester, and wherein the patch also comprises a release [protective] liner layer made of a paper laminate that has been subjected to a silicone treatment, as taught by Hatanaka ‘171, wherein the patch comprises a copolymer of ethylacrylate and methylmethacrylate [EUDRAGIT® NE 40] at from 39 – 55% wgt, and 42 – 55% of tributyl citrate, as taught by Cilurzo WO ‘256, and wherein the composition comprises butylhydroxyanisole (BHA) as an antioxidative component present at 0.001 to 10% wgt, as taught by Ito ‘095. One of skill in the art would be motivated to do so, with a reasonable expectation of success in so doing, by the disclosures of Cilurzo WO ‘256 and Ito ‘095 demonstrating the effectiveness of topical formulations comprising diclofenac sodium in an adhesive matrix of a copolymer of ethylacrylate and methylmethacrylate, and further comprising BHA, at the disclosed relative mass loadings.
With respect to the ranges of relative mass loadings as recited in the claims, the Examiner notes that the loadings taught in the cited references are not exactly congruent with the claim limitations. However, it is the Examiner’s position that the cited art teaches a range of loadings of these components that significantly overlap with the claimed loadings and, as such, would render the claimed invention obvious. See MPEP § 2144.05. “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).”
With respect to claims 7 and 12, it is the Examiner’s position that the recitations in those claims are directed to intended uses of the composition of the invention. Statements of intended use or function normally are not given patentable weight because they are not structurally limiting (see Cochlear Bone Anchored Sols. AB v. Oticon Med. AB, 958 F.3d 1348, 1354-55 (Fed. Cir. 2020).
Consequently, the cited art (directed to transdermal patches), taken as whole, discloses the same active, the same PSA matrix, the same plasticizer, the same antioxidant, the same backing layer, and the same release liner, all at loadings reading on the recited claim limitations. In the absence of any disclosure or claim limitations that would provide the structural or compositional characteristics of the claimed dosage form that correlate to the local release of a “medical plaster,” rather than systemic release from a transdermal patch, it is the Examiner’s position that there is no patentable distinction between the patch of the cited art and the plaster of the invention as claimed.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by claims 1 - 20 would have been obvious within the meaning of 35 USC § 103.
NO CLAIM IS ALLOWED.
CONCLUSION
Any inquiry concerning this communication or any other communications from the examiner should be directed to Daniel F. Coughlin whose telephone number is (571)270-3748. The examiner can normally be reached on M-F 8:30 am - 5:30 pm.
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/DANIEL F COUGHLIN/
Examiner, Art Unit 1619
/DAVID J BLANCHARD/ Supervisory Patent Examiner, Art Unit 1619