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
Continued Examination Pursuant to 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 18 May 2026
Status of the Claims
The Examiner acknowledges receipt of Applicants’ Response, filed 18 May 2026. In that Response, Applicants amended claim 1, canceled claims 7, 12, and 22 – 37, and added new claims 38 – 51. Consequently, claims 1, 2, 10 and 38 - 51 are available for active consideration.
REJECTIONS WITHDRAWN
Rejections Pursuant to 35 U.S.C. § 103
The obviousness rejections set forth in the Action of 28 January 2026 are hereby withdrawn in light of Applicants’ amendments to the claims, and in favor of the new grounds of rejection set forth below.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 pre-AIA 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office Action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived 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(s) 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, 2, 10, 38 – 44, 46 – 49, and 51 are rejected pursuant to 35 U.S.C. § 103, as being obvious over JP 2014-172840 A to Miyazaki, K. and W. Toru, published 22 September 2014, identified on the Information Disclosure Statement (IDS) filed 15 April 2022, cite no. 5 (FOR) (“Miyazaki JP ‘840”), in view of US 2009/0299304 A1 to Tang, J., published 3 December 2009 (“Tang ‘304”), and Meyer, B., et al., CLIN PHARMACOL THER 48: 340 – 345 (1990) (“Meyer (1990)”).
The Invention As Claimed
Applicants claim a transdermal absorption-type patch, comprising a support material, a promoter layer disposed between the support material and an adhesive layer, and the adhesive layer laminated on the support material via the promoter layer, wherein the adhesive layer comprises a solid composite material comprising leuprorelin as an active ingredient, enclosed by a surfactant with an HLB value of 5 or less, an oil phase, and an acrylic elastomer adhesive agent containing an alkyl(meth)acrylate having an alkyl group with 6 to 14 carbon atoms in an ester portion, wherein the content of the acrylic elastomer is 30% to 70% by mass, or 40 – 50% by mass, based on a total mass of the acrylic elastomer and the oil phase, wherein the composite material forms a solid-in-oil type particle dispersed in the oil phase, wherein the transdermal absorption promoter is dissolved in an oil phase in the promoter layer, wherein the promoter layer comprises an oil phase, and the oil phase in the promoter layer is the same as the oil phase in the adhesive layer, wherein the solid composite material is not contained in the promoter layer, wherein the active ingredient is not contained in the promoter layer, and wherein the promoter layer further comprises an acrylic elastomer, and the acrylic elastomer in the promoter layer is the same as the acrylic elastomer in the adhesive layer.
Applicants also claim a transdermal absorption-type patch wherein the oil phase of the patch comprises isopropyl myristate, wherein the content of the transdermal absorption promoter in the promoter layer is 1 % to 30% by mass based on a total mass of the transdermal absorption promoter and the oil phase in the promoter layer, wherein the active ingredient is not contained in the promoter layer, wherein the acrylic elastomer in the promoter layer is the same as the acrylic elastomer in the adhesive layer, and wherein the active ingredient is not contained in the promoter layer.
The Teachings of the Cited Art
Miyazaki JP ‘8401 discloses a patch that uses solid-in-oil (S/O) type fine particles in which
a hydrophilic drug is coated with a surfactant, and contains an adhesive composition which is combined with an acrylic polymer as an adhesive layer (see ¶[0009]), wherein the S/O type fine particles have a configuration in which a hydrophilic drug is coated with a surfactant, and the hydrophilic portion of the surfactant associates with the hydrophilic drug and coats the surroundings (see ¶[0015]), wherein the molecular weight of the hydrophilic drug in the present invention is preferably 10,000, or less (see ¶[0019]), wherein the surfactant can be used without any particular limitation as long as it is acceptable in pharmaceutical preparations, including nonionic surfactants, anionic surfactants, cationic surfactants, and amphoteric surfactants (see ¶[0020]), wherein the surfactant has an HLB value of 6, or less (see ¶[0022]), wherein the S/O-type fine particles may contain a stabilizer, such as hydrophilic proteins that are coated with a surfactant together with the hydrophilic drug, thereby improving the stability of the S/O particles, and preventing leakage of the hydrophilic drug outside the S/O type fine particles (A) in the patch (see ¶[0025]), wherein the particles are prepared by adding an organic solvent solution containing a surfactant and, if necessary, a stabilizer, to an aqueous solution containing a hydrophilic drug and, if necessary, a stabilizer, and mixed by high speed stirring using a homogenizer to prepare a water-in-oil (W/O) type emulsion, which is then dried by freeze-drying, or the like, to produce solid W/O type microparticles (see ¶[0030]), wherein the S/O type microparticles are preferably dispersed in oils and fats before being mixed with other components of the pressure-sensitive adhesive composition (see ¶[0031]), wherein a preferred long-chain fatty acid ester for the oil phase is isopropyl myristate (see ¶[0032]), wherein, when the S/O type microparticles are dispersed in fats and oils, the mass ratio of fats and oils to the S/O type microparticles is 0.1 to 5 (see ¶[0033]), wherein the acrylic polymer of the adhesive contains a constitutional unit represented by general formula (1), as depicted on p. 9, has excellent compatibility with the S/O-type microparticles, and is excellent in releasing a solid from S/O type microparticles (id.), wherein the acrylic polymer may be a copolymer of a monomer composition containing an alkyl (meth)acrylate ester having 6 to 14 carbon atoms in the alkyl group of the ester moiety and a monomer having a plurality of polymerizable unsaturated groups, such as 2-ethylhexyl(meth)acrylate (see ¶[0041]), wherein the pressure-sensitive adhesive composition, when the amount of the S/O type fine particles is A parts by mass, and the amount of the acrylic polymer is B parts by mass, the mass ratio A/B is from 1/99 to 60/40 (see ¶[0044]), wherein the adhesive composition contains a transdermal absorption enhancer at 0.1% to 60% by mass (see ¶[0055]), wherein the patch has an adhesive layer and a support substrate on one side of the adhesive layer (id.), wherein the substrate is an acrylic resin (see ¶[0062]), wherein the patch has a release sheet on at least one side of the adhesive layer, and functions to protect the adhesive surface of the adhesive layer during storage of the (unused) patch (see ¶[0062]), wherein, in an exemplified embodiment, a solution of 2.065 parts by mass of sucrose oleate as a surfactant was dissolved in 80 parts by mass of cyclohexane, and added to an aqueous solution of 0.085 parts by mass of a hydrophilic drug dissolved in 40 parts by mass of ultrapure water, and the mixture was stirred at high speed at 24,000 rpm for 5 minutes with a homogenizer to prepare a W/O type emulsion which was then freeze-dried for 2 days to obtain S/O-type fine particles (see ¶[0069]), wherein the content of the active in the microparticles was 4.0% mass (see ¶[0070]), wherein a monomer composition containing 95 mol% of lauryl acrylate and 5 mol% of 2-hydroxyethyl acrylate was solution polymerized using a radical polymerization initiator to obtain a solution of acrylic polymer with solids content at 34% mass (id.), and wherein 2.15 parts by mass of the S/O particles were added to 0.43 parts by mass of isopropyl myristate to prepare a dispersion, and 2.58 parts by mass of the dispersion and 0.026 parts by mass of a crosslinking agent were added to 6.3 parts by mass of a solution of the acrylic polymer, and the mixture was stirred to prepare the adhesive layer, followed by application of the adhesive mixture to a release liner, which was then heated and dried to yield a layer comprising 45.2% mass of the S/O particles comprising 1.8% mass active, and 9% mass of the oil phase, and a supporting substrate was laminated onto the adhesive layer to form the patch (see ¶[0071]). The reference does not disclose a patch wherein the active ingredient is leuprorelin, or a patch comprising a promoter layer disposed between the support material and the adhesive layer, wherein the promoter layer does not comprise the active ingredient. These deficiencies are remedied by the teachings of Tang ‘304 and Meyer (1990).
Tang ‘304 discloses a solid dispersion transdermal drug delivery system (TDDS) comprising a therapeutic agent in a stable amorphous form (see Abstract), wherein the TDDS comprises at least three layers, including a backing film, an adhesive layer, and a protective release liner, the
adhesive layer comprising an adhesive and a therapeutic agent (see ¶[0020]), wherein the TDDS can also include a fourth layer in the form of a second adhesive layer (a skin contact adhesive layer) that also comprises an adhesive and a therapeutic agent, wherein the second adhesive layer resides between the first adhesive layer (a drug reservoir adhesive layer) and the protective release liner (see ¶[0022]), wherein the adhesive layers (the drug reservoir adhesive layer and/or the skin contact adhesive layer) may additionally include a skin penetration enhancer [a promoter] (see ¶[0024]), wherein the drug reservoir adhesive layer and the skin contact adhesive layer may contain the same constituent components, although the amounts and/or specific types of any one component may vary between the two layers (see ¶[0042]), wherein the adhesive material contained in the adhesive layer may be any biocompatible polymer or polymeric material known in the art, such as acrylic adhesives, including cross-linked and uncross-linked
acrylic copolymers (see ¶[0044]), wherein the amount of adhesive material present in the at least one adhesive layer ranges from about 30% to about 95% by weight of the adhesive layer (see ¶[0045]), wherein the amount of the therapeutic agent present in the adhesive layer will vary and depend upon, among other factors, its identity, the intended dosing of the device, the number of adhesive layers present and the amount and identity of the therapeutic agent, the amount of the therapeutic agent ranging from about 0.5 to about 40% wgt based upon the weight of the adhesive material (see ¶[0054]), wherein, in embodiments containing two adhesive layers (see FIGS. 2 and 3), the amount of active pharmaceutical ingredient in the adhesive layers ranges from about 0% to about 5% by weight of the adhesive material (see ¶[0056]), wherein the adhesive layers may further comprise one or more pharmaceutically acceptable additives, such as penetration enhancers (see ¶[0069]), wherein the penetration enhancers can include isopropyl myristate (see ¶[0073]), in amounts ranging from about 0% to about 40% wgt of the adhesive material (see ¶[0074]), and wherein, in five-layer devices (see FIG. 3), both a drug reservoir adhesive layer and a skin contact adhesive layer are present, but separated by a membrane layer, with the skin contact adhesive layer being located between the membrane layer and the release liner so that the skin contact adhesive layer contacts and adheres to the skin subsequent to the removal of the release liner and application of the device to a patient’s skin (see ¶[0082]).
Meyer (1990) discloses the results of a comparison of the acute response of luteinizing hormone (LH) to the subcutaneous and transdermal administration of an LH-releasing hormone agonist, leuprolide [leuprorelin] (see Abstract), wherein poor oral bioavailability has constituted a major problem in the development of clinically useful polypeptide and protein drugs, wherein, because of extensive gastrointestinal degradation, it has been necessary to administer these drugs by subcutaneous, intramuscular, or intravenous injection, wherein a potentially attractive alternative to these modes of administration is the transdermal route, providing potential benefits such as the possibility of continuous infusion of drug during an extended period of time, avoidance of peak associated drug toxicity and trough-associated treatment failure, and improved compliance (see p. 340, 1st col., 1st para.), wherein Leuprolide [leuprorelin] is a 9 amino acid polypeptide that is without significant toxicity in single-dose studies in humans that is a useful model for evaluating transdermal administration of peptide drugs (see p. 340, 2nd col., 1st para.), wherein normal male volunteers were studied on 2 days, one week apart, receiving a transdermal patch containing leuprolide on the first day and receiving an injection of subcutaneous leuprolide on the second day (see p. 340, 2nd col, 3rd para.), wherein serum LH concentrations and serum testosterone concentrations from both days of administration of leuprolide were determined over a period of 12 hours, to yield values for peak LH concentration and times to peak LH concentration (see p. 342, 2nd col., 3rd para.) and no statistically significant differences were observed between the two different methods of administration (see Table II., p. 343), wherein alteration of the permeability characteristics of the stratum corneum by the use of permeation enhancers such as esters of long-chain fatty esters have produced improvements in transdermal absorption, presumably by altering the structure of the extracellular matrix within the stratum corneum (see p. 343, 2nd col., last para. – p. 344, 1st col., 1st para.), and wherein the data indicates that, although the subcutaneous route produces a more rapid onset of LH response, the two techniques are very similar in the magnitude and duration of the response achieved, and peak LH responses were indistinguishable while, after 150 minutes, the two LH response curves are virtually identical (see p. 344, 1st col., last para. – 2nd col., 1st para.).
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 transdermal patch that uses solid-in-oil (S/O) type fine particles in which a hydrophilic drug is coated with a surfactant, and contains an adhesive layer with an adhesive composition comprising an acrylic polymer, wherein the molecular weight of the hydrophilic drug in the present invention is preferably 10,000, or less, wherein the S/O type microparticles are preferably dispersed in oils and fats before being mixed with other components of the pressure-sensitive adhesive composition, wherein a preferred long-chain fatty acid ester for the oil phase is isopropyl myristate, wherein, when the S/O type microparticles are dispersed in fats and oils, the mass ratio of fats and oils to the S/O type microparticles is 0.1 to 5, wherein the acrylic polymer of the adhesive contains an alkyl (meth)acrylate ester having 6 to 14 carbon atoms in the alkyl group of the ester moiety and a monomer having a plurality of polymerizable unsaturated groups, such as 2-ethylhexyl(meth)acrylate, wherein the pressure-sensitive adhesive composition, when the amount of the S/O type fine particles is A parts by mass, and the amount of the acrylic polymer is B parts by mass, the mass ratio A/B is from 1/99 to 60/40, wherein the adhesive composition contains a transdermal absorption enhancer at 0.1% to 60% by mass, wherein the patch has a support substrate on one side of the adhesive layer, the adhesive mixture is laminated to a release liner, which was then heated and dried to yield a layer comprising 45.2% mass of the S/O particles comprising 1.8% mass active, and 9% mass of the oil phase, and a supporting substrate was laminated onto the adhesive layer to form the patch, as taught by Miyazaki JP ‘840, wherein the patch of Miyazaki JP ‘840 is modified to comprise up to five layers, those layers comprising both a drug reservoir adhesive layer and a skin contact adhesive layer, with the skin contact adhesive layer being laminated to the release liner so that the skin contact adhesive layer contacts and adheres to the skin subsequent to the removal of the release liner and application of the device to a patient’s skin, wherein the skin contact adhesive layer includes a skin penetration enhancer [a permeation promoter], wherein the drug reservoir adhesive layer and the skin contact adhesive layer may contain the same constituent components, although the amounts and/or specific types of any one component may vary between the two layers, wherein the adhesive material contained in the adhesive layer may be any biocompatible polymer or polymeric material known in the art, such as acrylic adhesives, including cross-linked and uncross-linked acrylic copolymers, present in the adhesive layers in a range from about 30% to about 95% by weight of the adhesive layer, wherein, in the five-layer embodiments containing both a drug reservoir adhesive layer and a skin contact layer, the amount of active pharmaceutical ingredient in the adhesive layers ranges from about 0% to about 5% by weight of the adhesive material, wherein the adhesive layers further comprise one or more penetration enhancers, wherein the penetration enhancers are present in amounts ranging from about 0% to about 40% wgt of the adhesive material, as taught by Tang ‘304, and wherein the active ingredient is leuprolide [leuprorelin], as taught by Meyer (1990). One of ordinary skill in the art would be motivated to do so, with a reasonable expectation of success in so doing by the teachings of Meyer (1990) to the effect that, when normal male volunteers were studied on 2 days, one week apart, receiving a transdermal patch containing leuprolide on the first day and receiving an injection of subcutaneous leuprolide on the second day (see p. 340, 2nd col, 3rd para.), wherein serum LH concentrations and serum testosterone concentrations from both days of administration of leuprolide yielded values for peak LH concentration and times to peak LH concentration (see p. 342, 2nd col., 3rd para.), and that no statistically significant differences were observed between the two different methods of administration (see Table II., p. 343), wherein the data indicates that the two administration techniques are very similar in the magnitude and duration of the response achieved, and peak LH responses were indistinguishable while, after 150 minutes, the two LH response curves are virtually identical (see p. 344, 1st col., last para. – 2nd col., 1st para.), allowing for the use of an advantageous route of administration (see p. 340, 1st col., 1st para.).
With respect to those claims reciting quantitative limitations directed to relative mass per cents of various components in the patches (see claims 1, 2, 43, 46), the Examiner notes that the cited art discloses relative mass amounts for various components of the patches that are not exactly congruent with the claimed ranges. However, it is the Examiner’s position that the cited art teaches a range of loadings of these components that significantly overlaps 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).”
Further with respect to claims, such as claim 1, that recite the relative loading of the acrylic elastomer on a basis of the total mass of the acrylic elastomer and the oil phase, the Examiner notes that the cited art does not discloses loadings of the acrylic adhesives relative to the total mass of the adhesive layer, including the oil phase. However, the Examiner further notes that Miyazaki JP ‘840 specifically discloses that the mass ratio of fats and oils to the S/O type microparticles is 0.1 to 5 (see ¶[0033]), and that, when the amount of the S/O type fine particles is A parts by mass, and the amount of the acrylic polymer is B parts by mass, the mass ratio A/B is from 1/99 to 60/40 (see ¶[0044]). Consequently, it is the Examiner’s position that based on these disclosures, compositions according to the cited art would necessarily at least significantly overlap with the claimed ranges, rendering them obvious. See In re Wertheim.
With respect to claim 38, which claim recites a limitation directed to the transdermal absorption promoter being dissolved in an oil phase in the promoter layer of the transdermal patch of the invention, the Examiner notes that the cited references do not expressly teach such compositional characteristics of the promoter layer (skin contact layer: see Tang ‘304). However, the Examiner further notes that the logic of the rejection lies in adding an additional layer (the skin contact layer) to the transdermal patches of Miyazaki JP ‘840. Furthermore, Tang ‘304 discloses that the composition of the skin contact layer can comprise the same components as the active ingredient reservoir layer, although not necessarily in the same relative amounts. Thus, based on this disclosure, the skin contact layer (a second adhesive layer), would possess the same acrylic adhesives and the same oils, leading one of ordinary skill in the art to appreciate that the same permeation enhancer in the same oil would likewise be present in a dissolved state in the skin contact layer.
With respect to claims 40, 41, and 51, which claims recite limitations directed to the promoter layer not containing either the solid composite material or, more specifically, the active ingredient, the Examiner notes that Tang ‘304 discloses that the skin contact layer comprises the active ingredient in a range of from 0 to 40% wgt of the adhesive material. Obviously, at a loading of 0%, the layer would not comprise the active ingredient.
With respect to claim 44, which claim recites a limitation directed to the oil phase further comprising isopropyl myristate, the Examiner notes that Miyazaki JP ‘840 specifically discloses the use of isopropyl myristate, although characterizing it as a permeation enhancer.
Claims 39, 42, 48, and 49 recite limitations to the effect that components of the adhesive layers (other than active ingredient) are the same in both the active reservoir layer and the promoter layer. In this regard, Tang ‘304 discloses that the drug reservoir adhesive layer and the skin contact adhesive layer may contain the same constituent components, although the amounts and/or specific types of any one component may vary between the two layers (see ¶[0042]).
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by claims 1, 2, 10 38 – 44, 46 – 49, and 51 would have been obvious within the meaning of 35 USC § 103.
Claims 45 and 50 are rejected pursuant to 35 U.S.C. § 103, as being obvious over Miyazaki JP ‘840, in view of Tang ‘304, and Meyer (1990), as applied in the above rejection of claims 1, 2, 10, 38 – 44, 46 – 49, and further in view of US 2013/0165875 A1 to Choi, Y., et al., published 27 June 2013 (“Choi ‘875”).
The Invention As Claimed
The invention with respect to claim 1 is described above. In addition, Applicants claim a transdermal patch comprising glyceryl monooleate as a transdermal absorption promoter.
The Teachings of the Cited Art
The teachings of Miyazaki JP ‘840, Tang ‘304, and Meyer (1990) are relied upon as in the above rejection of claims 1, 2, 10, 38 – 44, 46 – 49. The references do not disclose a transdermal patch comprising glyceryl monooleate as the transdermal absorption promoter. The teachings of Choi ‘875 remedy that deficiency.
Choi ‘875 discloses a transdermal absorption preparation that comprises a drug-containing adhesive layer, a drug-protective layer, and a release layer, wherein the drug-containing adhesive layer contains an acrylic rubber, an anti-crystallization agent, and a transdermal absorption promoter (see Abstract), wherein the drug-containing adhesive layer contains directly comes into contact with the skin by a pressure-sensitive adhesion system (see ¶[0019]), wherein the transdermal absorption promoter is used to increase the efficiency of delivering the drug to the skin (see ¶[0034]), wherein the absorption promoter is glycerol [glyceryl] monooleate (see ¶[0035]), included in an amount of 5 – 20% wgt based on the total weight of the adhesive layer (see ¶[0036]), and wherein the acrylic adhesive may be a polyacrylate block copolymer including at least one selected from the group consisting of acrylic acid, 2-ethylbezyl acrylate, butyl acrylate, 2-hydroxyethyl acrylate, methyl methacrylate, laethyl acrylate, glycidyl methacrylate, vinyl acetate, N-vinyl-2-pyrrolidone, diacetone acrylamide, t-octyl acrylamide, and 2-(dimethyl aminoethyl) methacrylate (see ¶[0046]), included in an amount of 30 – 90% wgt (see ¶[0047]).
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 transdermal patch that uses solid-in-oil (S/O) type fine particles in which a hydrophilic drug, such as leuprorelin, is coated with a surfactant, and contains an adhesive layer with an adhesive composition comprising an acrylic polymer, wherein the microparticles are dispersed in oils and fats, wherein a preferred long-chain fatty acid ester for the oil phase is isopropyl myristate, wherein the adhesive composition contains a transdermal absorption enhancer at 0.1% to 60% by mass, wherein the patch has a support substrate on one side of the adhesive layer, and the adhesive mixture is laminated to a release liner, wherein the patch has a drug-containing adhesive layer and a skin contact adhesive layer [promoter layer], as taught by Miyazaki JP ‘840, Meyer (1990), and Tang ‘304, wherein the patch comprises glyceryl monooleate as the transdermal permeation promoter, in addition to the isopropyl myristate of Miyazaki JP ‘840, as taught by Choi ‘875. One of ordinary skill in the art would be motivated to do so, with a reasonable expectation of success in so doing, by the art-recognized principle that the selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination (see Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945) (as cited in MPEP § 2144.07).
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by claims 45 and 50 would have been obvious within the meaning of 35 USC § 103.
Response to Applicants’ Arguments
The Examiner has considered the arguments submitted by Applicants in their Response of 18 May 2026, but does not find them persuasive, to the extent still relevant in light of the new grounds of rejection set forth above. Applicants first argue that “Miyazaki's A/B ratio and the claimed elastomer-content range are parameters defined over different denominators,” leading Applicants to conclude that “the overlapping-ranges doctrine of MPEP § 2144.05 / In re Wertheim is therefore inapplicable.” The Examiner respectfully disagrees, largely on the basis that Applicants’ example calculation is based on a single exemplified embodiment (see Miyazaki JP ‘850, ¶¶[0072] – [0073]), and ignores additional teachings disclosing that, when the amount of the S/O type fine particles (A) is A parts by mass and the amount of the acrylic polymer (B) is B parts by mass, the mass ratio A/B is preferably 1/99 to 60/40 (see ¶[0044]), and that, when S/O type microparticles are dispersed in fats and oils, the mass ratio of fats and oils to S/O type microparticles is preferably 0.1 to 5 (see ¶[0033]). Thus, given the relatively broad range of possible proportions among the disclosed components, it is the Examiner’s position that transdermal patches according to the cited references would necessarily at least significantly overlap with the claimed range.
Applicants also argue that the spatial layer assignments of Stefano ‘116 is the opposite of the characterization presented in the Action of 28 January 2026. However, the new grounds of rejection set forth above no longer cite to Stefano ‘116 and instead cite to Tang ‘304 for disclosure of a transdermal patch with multiple adhesive layers, including a drug-reservoir adhesive layer and a skin contact adhesive layer, the latter of which contains a permeation enhancer and is free of active ingredient (see FIG. 3). Applicants’ argument that Stefano ‘116 is not analogous art is now moot in that the rejection of record no longer relies on the teachings of that reference.
Consequently, based upon the above discussion, Applicants’ arguments are unpersuasive, and claims 1, 2, 10, and 38 – 51 stand rejected pursuant to 35 U.S.C. § 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.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, David J 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
1 Citations to the reference are to the English language machine translation, previously provided.
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