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
The Examiner acknowledges receipt of Applicant’s Response, filed 22 June 2026. Applicant amended claims 1, 3, 4, 8, 10, 11, and 13 - 15 therein. Accordingly, claims 1 – 20 remain available for active consideration.
REJECTIONS WITHDRAWN
Rejections Pursuant to 35 U.S.C. § 103
The obviousness rejection set forth in the Action of 22 January 2026 is hereby withdrawn in light of Applicant’s amendment of claim 1, and in favor of the new grounds of rejection set forth below.
NEW GROUNDS OF REJECTION
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. Applicant is 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”), as evidenced by Applicant’s specification.
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 concentrations ranging from 1 to 20%, or 5 – 10%, or 7.25%, by weight with respect to the dry weight of the matrix, wherein the medical plaster releases the active ingredient for 24 hours at therapeutically active concentrations on a site of application, 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 [cf. 1 – 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 [cf. 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 [cf. 40 – 49% 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 medical plaster that releases the active ingredient for 24 hours at therapeutically active concentrations on a site of application, or 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 [cf. 40 – 49% wgt], from 4 – 12% of the diclofenac salt [cf. 1 – 20% wgt], and from 42 – 55% of a citric acid ester [cf. 40 – 49% wgt], 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 amended claim 1, which claim recites a limitation directed to the functional characteristic of release of diclofenac sodium for 24 hours after application, the Examiner notes that topical dosage forms according to the cited art disclose the same active ingredient (diclofenac sodium, at 1 – 20% wgt; cf. diclofenac sodium is present at from 1 to 20% wgt: Hatanaka ‘171, at ¶[0029]), the same PSA matrix (a neutral copolymer based on ethyl acrylate and methyl methacrylate in a 2: 1 ratio, in a concentration ranging from 40 to 49%; cf, a copolymer of ethylacrylate and methylmethacrylate [EUDRAGIT® NE 40] at 39 – 55%: Cilurzo WO ‘256 at p. 1, ll. 19 – 20; p. 2, ll. 8 - 9), the same plasticizer (tributyl citrate, at 40 – 49% wgt; cf. 42 – 55% tributyl citrate: Cilurzo WO ‘256 at EXAMPLE 4), the same antioxidant (BHA, at 0.10 – 0.20% wgt; cf. butylhydroxyanisole as an antioxidative component, present at 0.001 to 10% wgt: Ito ‘095, at ¶¶[0026], [0030]), the same backing layer (a non-perforated 100% polyester non-woven fabric; cf. a support layer of non-woven polyester: Hatanaka ‘171 at ¶[0047]), and the same release liner (a protective sheet of monosilicone paper; cf. a release liner layer made of a paper laminate that has been subjected to a silicone treatment: Hatanaka ‘171 at ¶[0048]). In the absence of any additional disclosure or claim limitations that would identify claimed structural or compositional characteristics of the inventive dosage forms that correlate to a release profile over 24 hours following application, 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. The invention is not structurally or compositionally distinguishable from the combination of the cited art and it is, therefore, the Examiner's position that the ability of a formulation according to the cited art to release diclofenac sodium over a 24-hour period is an inherent property of that formulation such that diclofenac sodium would necessarily be released over 24 hours. Furthermore, as evidenced by Applicants’ specification, at ¶[0045], the extended-release property of the claimed formulations is due to the minimal concentrations of BHA in the formulations. Because the Patent and Trademark Office does not have the facilities for examining and comparing the claimed formulation with the formulation of the cited art, the burden of proof is upon Applicant to show an unobvious distinction between the structural and functional characteristics of the claimed formulation and the formulation of the prior art. See In re Best, 562 F.2d 1252, 195 U.S.P.O. 430 (CCPA 197), and Ex parte Gray, 10 USPO 2d 1922 1923 (PTO Bd. Pat. App. & Int.).
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).
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.
Response to Applicant’s Arguments
The Examiner has considered the arguments offered by Applicant in the Response filed 22 June 2026, but does not find them persuasive. Applicant first argues that “the claimed invention releases the active ingredient only at the site of application (thus behaving as a medical plaster) and not into the bloodstream (as transdermal patches do),” in attempting to distinguish over the cited art. In this regard, the Examiner would first note that one of ordinary skill in the art would recognize that all transdermal dosage forms, whether medical plasters or transdermal patches, initially release the active ingredient into the wearer’s body at the point of application. Applicant apparently bases the “patch vs. plaster” distinction on what happens in vivo after application of the dosage form to a patient’s skin.
In this regard, the Examiner first notes that the invention as claimed is directed to the statutory category of “composition of matter.” Consequently, 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,” a contention Applicant repeats in the current arguments. However, the disclosures relating to the definitions of patch and plaster in Applicant’s specification do not address any specific structural or compositional factors that directly correlate to the mechanisms of action – local (plaster) or systemic (patch). 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” (see, for example, Title, Abstract), which is a term that 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. More specifically, Applicant argues, based on the European Pharmacopoeia definition, that “medicated plasters do not allow the active substance to reach the bloodstream.” However, Applicant has yet to point to specific structural and/or compositional characteristics of their claimed dosage form that are responsible for preventing the active ingredient from entering the wearer’s blood stream.
Applicant’s specification also points to a comparison between a commercial “plaster” product, FLECTOR®, and the dosage form of the invention, revealing “absolutely comparable” release profiles between the two products, apparently suggesting that because release occurs over 24 hours the two dosage forms are plasters. However, product information for the FLECTOR® dosage form from IBSA Pharma Inc. (Flector® IBSA, obtained from the Internet at https://flector.com/hcp on 31 August 2026) used the terms, “topical system” and “patch” to describe the product. No where in the document is the term, “plaster,” used.
Furthermore, with respect to 24-hour release of active, Applicant’s specification (see p. 4, ll. 14 – 16) distinguishes between Cilurzo WO ‘256 and the present invention on the basis of the salts of diclofenac in the “medical plaster” of the invention (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 relevance here is that, to the extent that Applicant is attempting to distinguish between plasters and patches, or to define a plaster on the basis of delivering active over a 24-hour period after application, Cilurzo WO ‘256 unambiguously refers to its dosage forms as “patches,” despite the prolonged release of active over 24 hours.
Also of relevance here is Applicant’s disclosure (see p. 9, ll. 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 the antioxidant, BHA, a compositional characteristic, as being responsible for the release profile that Cilurzo WO ‘256 could not achieve with diclofenac sodium, and not to the structure/composition of “plaster” vs. a “patch.”
Consequently, it is the Examiner’s position that the terms “plaster” and “patch” are interchangeable in the absence of any structural or compositional characteristics (aside from 24-hour release) that would support a patentable distinction based on alleged definitions of the two terms.
Despite the obviously tenuous nature of the alleged distinction between plaster and patch terminology, Applicant persists in arguing that the dosage form disclosed in the primary obviousness reference, Hatanaka ‘171, is a patch, and not a plaster. Applicant further attempts to distinguish over Hatanaka ‘171 on the basis that the patch produces a systemic effect (see, for example, ¶[0003]), unlike the dosage form of the claimed invention. However, nowhere does Applicant’s specification disclose data on the levels of diclofenac sodium either in the patient’s blood stream, or at the site of application. Despite relying heavily on the “local” only delivery of active from the claimed dosage form, Applicant provides no data in support of such contention, and only discloses data comparing in vitro release over 24 hours to the commercial FLECTOR® product. Applicant is arguing that the dosage form of the invention works “in a different way” from transdermal patches on the basis of “local” effects only, without providing any data or evidence in support of such contention. Without any reason to take issue with the European Pharmacopoeia definitions of plaster and patch, it is the Examiner’s position that Applicant is effectively arguing that the claimed product limits release of the active to the site of application because it is a “plaster,” rather than establishing that it is a plaster because it limits release of the active to the site of application. As to the 24-hour release of active, as the above discussion has pointed out, such release is not limited to dosage forms defined as plasters, but can be achieved with transdermal patches. Furthermore, Applicant’s own disclosure attributes such extended release to the inclusion of BHA in the topical composition of the invention, which disclosure could, in fact, be considered the fundamental invention, even though not claimed.
Applicant also relies on the Declaration of Mauro Pavan, associated with the Assignee of the present application, to support the contention that “the patches according to the claimed invention belong to the category of medicated plasters, according to international Pharmacopoeia definitions, because the claimed invention is fully comparable - in terms of active-ingredient release - to a medicated plaster registered in the USA (i.e., the Flector patch - see attached Annex).” However, the Declaration solely bases it conclusions on a comparison between the in vitro release data of the claimed invention and the commercial FLECTOR® product, somehow relying on a logical approach that constant release over 24 hours is sufficient to establish that release is limited to local effects only. However, as discussed above, it is possible to achieve extended, 24-hour release from a transdermal patch (see Hatanaka ‘171), even though with a different diclofenac salt, possibly pointing out the real contribution of the present invention – formulating diclofenac sodium with BHA enables the 24-hour release.
Consequently, based on the above discussion, Applicant’s arguments are unpersuasive and claims 1 – 20 stand rejected as obvious pursuant to 35 U.S.C. § 103.
NO CLAIM IS ALLOWED.
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.
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 a.m. - 5:00 p.m.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, David Blanchard, can be reached on (571)272-0827. The fax phone number for the organization where this application or proceeding is assigned is (571)273-8300.
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/DANIEL F COUGHLIN/
Examiner, Art Unit 1619
/DAVID J BLANCHARD/ Supervisory Patent Examiner, Art Unit 1619
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