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 Applicants’ Response, filed 4 September 2025. Claim 1 is amended therein, and claims 6, 8, 10, and 12 are cancelled. Accordingly, claims 6, 8, 10, and 12 remain available for active consideration.
REJECTIONS WITHDRAWN
Rejections Pursuant to 35 U.S.C. § 103
The obviousness rejection set forth in the Action of 18 June 2025 in light of Applicants’ amendment of the claims, and in favor of the new grounds of rejection set forth below.
Double Patenting
The obviousness-type double patenting rejection over claims 11 – 14 of co-pending application serial number 18/036,203 is hereby withdrawn in light of the cancelation of claims 11 – 14 in that application.
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. 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 5, 7, 9, and 11 are rejected pursuant to 35 U.S.C. § 103, as being obvious over US 2019/0000775 A1 to Yasukochi, T., et al., published 3 January 2019, identified on the Information Disclosure Statement (IDS) filed 9 May 2023, cite no. 1 (USPATAPP) (“Yasukochi ‘775”), as evidenced by Applicants’ specification.
The Invention As Claimed
Applicants claim a method for suppressing degradation of asenapine in a patch comprising an adhesive layer on a backing, the adhesive layer consisting of a styrene-isoprene-styrene block copolymer, asenapine, or a pharmaceutically acceptable salt thereof, and at least one amine compound, such as monoethanolamine, diethanolamine, diisopropanolamine, isopropanolamine, triethanolamine, or meglumine, present at a content of from 0.01 to 1% mass relative to the total mass of the adhesive layer, and further comprising dibutylhydroxytoluene.
The Teachings of the Cited Art
Yasukochi ‘775 discloses a patch comprising a backing layer and an adhesive layer laminated on one side of the backing, wherein the adhesive layer comprises asenapine, and an adhesive base (see Abstract; see also, ¶[0020]), wherein reduction of adhesion of the patch due to moisture absorption can be inhibited in a patch containing any adhesive base, such as a silicone adhesive base, an acrylic adhesive base, or a rubber adhesive base (see ¶[0012]), wherein the adhesive layer further comprises a low molecular weight amine, such as monoethanolamine, diethanolamine, triethanolamine, isopropanolamine, or diisopropanolamine (see ¶[0010]), present at 0.5 to 40% wgt of the adhesive layer (see ¶[0049]), wherein the adhesive base preferably is selected from a rubber adhesive base, or an acrylic adhesive base, or a silicone adhesive base, the adhesive base comprising from 40 – 98% wgt of the adhesive layer (see ¶[0024]), wherein the rubber adhesive comprises a styrene-isoprene-styrene (SIS) block copolymer (see ¶[0025]), used alone, or with polyisobutylene (see ¶[0026]), wherein, when the adhesive base comprises a rubber adhesive, the content of the rubber adhesive in the adhesive layer is up to 98% wgt, relative to the total mass of the adhesive layer (see ¶[0027]), wherein the adhesive layer may further contain other additives, including a tackifier resin, a plasticizer, a percutaneous absorption promoting agent, a stabilizing agent, a filler, or a flavor (see ¶[0034]), wherein the content of the tackifier resin in the adhesive layer is up to 80% wgt, relative to the total mass of the adhesive layer (see ¶[0036]), wherein the content of the absorption promoting agent is up to 30% wgt relative to the total mass of the adhesive layer (see ¶[0038]), wherein the adhesive layer further comprises a stabilizing agent, such as dibutylhydroxytoluene (see ¶[0039]), at a content of up to 5% wgt relative to the total mass of the adhesive layer (see ¶[0040]), and wherein the content of other additives in the adhesive layer is from 0 to 30% wgt, relative to the total mass of the adhesive composition. The reference does not expressly disclose a patch that suppresses degradation of asenapine.
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 backing layer and an adhesive layer laminated on one side of the backing, the adhesive layer comprising asenapine as the active ingredient, and an adhesive base, the adhesive base comprising a styrene-isoprene-styrene (SIS) block copolymer, and further comprising a low molecular weight amine, such as monoethanolamine, diethanolamine, triethanolamine, isopropanolamine, or diisopropanolamine, at a content of from 0.5 to 40% wgt, and a stabilizing agent, such as dibutylhydroxytoluene, to enhance the stability of the patch, as disclosed by Yasukochi ‘775.
With respect to the recited purpose of the method of the invention, the Examiner notes that the reference does not directly address the stability of the patch preparation in terms of preventing degradation of the active ingredient, asenapine. However, it is the Examiner’s position that a patch formulation comprising asenapine, or a pharmaceutically effective salt thereof, a styrene-isoprene-styrene adhesive base, dibutylhydroxytoluene as a stabilizer/antioxidant and, in addition, an amine compound, such as monoethanolamine, diethanolamine, triethanolamine, isopropanolamine, or diisopropanolamine, at loadings of 0.5 to 40% wgt, would, based on disclosure in Applicants’ specification to the effect that it is the presence of the amine that is responsible for suppressing degradation of the asenapine (see ¶[0006]), necessarily be effective in reducing degradation of the active during use (or storage). Furthermore, given that it would be reasonable to conclude that Applicants’ invention as claimed reflects that, in fact, the invention comprises nothing more than a recognition by Applicants as to a reduction in degradation of the active arising from the inclusion of low-molecular weight amines in the asenapine patch formulation. See MPEP § 2112.02 (II), specifically “In re Tomlinson, 363 F.2d 928, 150 USPQ 623 (CCPA 1966) (The claim was directed to a process of inhibiting light degradation of polypropylene by mixing it with one of a genus of compounds, including nickel dithiocarbamate. A reference taught mixing polypropylene with nickel dithiocarbamate to lower heat degradation. The court held that the claims read on the obvious process of mixing polypropylene with the nickel dithiocarbamate and that the preamble of the claim was merely directed to the result of mixing the two materials. ‘While the references do not show a specific recognition of that result, its discovery by appellants is tantamount only to finding a property in the old composition.’ 363 F.2d at 934, 150 USPQ at 628 (emphasis in original)).” See also MPEP § 2145(II): “Mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention. In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA 1979). (Claims were directed to grooved carbon disc brakes wherein the grooves were provided to vent steam or vapor during a braking action. A prior art reference taught noncarbon disc brakes which were grooved for the purpose of cooling the faces of the braking members and eliminating dust. The court held [that] the prior art references when combined would overcome the problems of dust and overheating solved by the prior art and would inherently overcome the steam or vapor cause of the problem relied upon for patentability by applicants. Granting a patent on the discovery of an unknown but inherent function (here venting steam or vapor) ‘would remove from the public that which is in the public domain by virtue of its inclusion in, or obviousness from, the prior art.’ 596 F.2d at 1022, 201 USPQ at 661);” MPEP § 2112 I.: “‘[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.’ Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable.”
With respect to the choice of adhesive base in the adhesive layer of the asenapine patch, the Examiner notes that Applicants have amended claim 5 to recite that the adhesive base of the adhesive layer “consists of” a styrene-isoprene-styrene block copolymer, use of the restrictive “consists of” transitional phrase being interpreted as excluding any ingredient not specified in the claim (see MPEP § 2111.03 II.). In this regard, the Examiner further notes that the cited reference discloses multiple embodiments of adhesive bases for the adhesive layer, among them embodiments comprising both rubber and acrylic adhesive bases. However, it is the Examiner’s position that, among these various embodiments, the reference clearly discloses embodiments where the adhesive layer, as cited above, comprises only a styrene-isoprene-styrene adhesive base. Further, the reference discloses that the rubber adhesive base comprising only styrene-isoprene-styrene adhesive base (see ¶¶[0025] – [0026]) can comprise up to 98% wgt of the adhesive layer (see ¶[0027]), and that the adhesive layer can comprise up to 30% wgt of additives (see ¶[0050]), as well as from 1 – 30% wgt asenapine (see ¶[0047]), all of which are reasonably read to encompass an embodiment comprising only styrene-isoprene-styrene as the adhesive base.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by claims 5, 7, 9, and 11 would have been obvious within the meaning of 35 USC § 103.
Response to Applicants’ Arguments
The Examiner has considered the arguments presented with Applicants’ Response filed 4 September 2025 but does not find them persuasive, to the extent still relevant in light of the new grounds of rejection set forth above. App0licants first argue that “the cited reference fails to teach or suggest all of the claim features.” The Examiner respectfully disagrees.
Applicants’ argument focuses on the newly added limitation now recited in claim 5 directed to the adhesive base “consisting of” a styrene-isoprene-styrene adhesive, alleging that the cited reference “teaches the disclosed enhanced properties of the composition, i.e., the improved releasing properties of asenapine from the adhesive layer and the more sufficient adhesion of the adhesive layer, may be achieved by way of the combination of both the SIS and the PIB.” In this regard, the Examiner first notes that the reference explicitly discloses that “reduction of the adhesion due to moisture absorption can be inhibited in a patch containing any adhesive base of a silicone adhesive base, an acrylic adhesive base, and a rubber adhesive base” (see ¶[0012]). Further, the reference discloses that the rubber adhesive can contain only styrene-isoprene-styrene (see ¶¶[0025] – [0026]). Consequently, it is the Examiner’s position that Applicant’s arguments are based on Examples/specific embodiments from the reference, and not to the teachings of the reference as a whole, thus improperly focusing on a specific embodiment comprising a combination of styrene-isoprene-styrene and polyisobutylene, and ignoring what the reference discloses or suggests to the skilled artisan. See MPEP § 2123: "The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain." In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983) (quoting In re Lemelson, 397 F.2d 1006, 1009, 158 USPQ 275, 277 (CCPA 1968)).
A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill the art, including nonpreferred embodiments. Merck & Co. v. Biocraft Laboratories, 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989). See also Upsher-Smith Labs. v. Pamlab, LLC, 412 F.3d 1319, 1323, 75 USPQ2d 1213, 1215 (Fed. Cir. 2005) (reference disclosing optional inclusion of a particular component teaches compositions that both do and do not contain that component).” Thus, as cited above, the reference clearly discloses embodiments wherein the adhesive base comprises only styrene-isoprene-styrene, reading on amended claim 5.
With respect to the method as claimed in claim 5, it is the Examiner’s position that a patch formulation with an adhesive layer comprising asenapine, or a pharmaceutically effective salt thereof, a styrene-isoprene-styrene adhesive base, dibutylhydroxytoluene as a stabilizer/antioxidant and, in addition, an amine compound, such as monoethanolamine, diethanolamine, triethanolamine, isopropanolamine, or diisopropanolamine, at loadings of 0.5 to 40% wgt, would, based on disclosure in Applicants’ specification to the effect that it is the presence of the amine that is responsible for suppressing degradation of the asenapine (see ¶[0006]), necessarily be effective in reducing degradation of the active during use (or storage). Furthermore, Applicants’ invention as claimed reflects that, in fact, the invention comprises nothing more than a recognition by Applicants as to a reduction in degradation of the active arising from the inclusion of low-molecular weight amines in the asenapine patch formulation. See MPEP § 2112.02 (II), specifically “In re Tomlinson, 363 F.2d 928, 150 USPQ 623 (CCPA 1966) (The claim was directed to a process of inhibiting light degradation of polypropylene by mixing it with one of a genus of compounds, including nickel dithiocarbamate. A reference taught mixing polypropylene with nickel dithiocarbamate to lower heat degradation. The court held that the claims read on the obvious process of mixing polypropylene with the nickel dithiocarbamate and that the preamble of the claim was merely directed to the result of mixing the two materials. ‘While the references do not show a specific recognition of that result, its discovery by appellants is tantamount only to finding a property in the old composition.’ 363 F.2d at 934, 150 USPQ at 628 (emphasis in original)).” See also MPEP § 2145(II): “Mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention. In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA 1979).” See also MPEP § 2112 I.: “‘[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.’ Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable.”
Consequently, based on the above discussion, Applicants’ arguments are unpersuasive, and claims 5, 7, 9, and 11 stand rejected 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