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 5 December 2025. Claims 7, 9, 15, and 17 are amended therein, and claims 8, 10, 16, and 18 are cancelled. Claims 15 and 17, and new claims 21 and 22, are withdrawn as being directed to a non-elected invention. Accordingly, claims 7, 9, 19, and 20 are available for active consideration.
Claim Issues
The Examiner notes that the claim set provided with Applicants’ Amendment filed 5 December 2025 indicates that Applicants have amended claim 1. However, there are no additions or deletions indicated in the claim. The Examiner further notes that the last two “wherein” clauses in the claim were not recited in previous versions of the claim. Appropriate correction is necessary.
REJECTIONS WITHDRAWN
Rejections Pursuant to 35 U.S.C. § 112
The rejection pursuant to 35 U.S.C. § 112(b) set forth in the Action of 11 September 2025 is hereby withdrawn in light of Applicants’ amendment of the claims.
Rejections Pursuant to 35 U.S.C. § 103
The rejection pursuant to 35 U.S.C. § 103 set forth in the Action of 11 September 2025 is hereby withdrawn in light of Applicants’ amendment of the claims, and in favor of the new grounds of rejection set forth below.
Obviousness-Type Double Patenting
The double patenting rejections set forth in the Action of 11 September 2025 are hereby withdrawn in light of Applicants’ amendment of the claims, and in favor of the new grounds of rejection set forth below.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 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 7, 9, 19, and 20 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 10 May 2023, cite no. 1 (USPATAPP) (“Yasukochi ‘775”), in view of US 2011/0159048 A1 to Crain, S., et al., published 30 June 2011 (“Crain ‘048”).
The Invention As Claimed
Applicants claim a patch comprising an adhesive layer on a backing, the adhesive layer comprising an adhesive base, asenapine (or a pharmaceutically acceptable salt thereof), and at least one basic amino acid, such as lysine, arginine, or histidine (or pharmaceutically acceptable salts thereof), wherein the adhesive base comprises a rubber adhesive base, and wherein the patch comprises no more than 0.41% by weight of the asenapine in an N-oxide form thereof after storage at 60°C for one month, and wherein a content of the at least one basic amino acid, or the pharmaceutically acceptable salt thereof, is 0.01 to 7% mass with respect to a total mass of the adhesive layer.
Applicants also claim a patch comprising an adhesive layer on a backing, wherein the adhesive layer comprises an adhesive base, asenapine or a pharmaceutically acceptable salt thereof, and at least one basic amino acid such as lysine, arginine, or histidine, or a pharmaceutically acceptable salt thereof, wherein the adhesive base is a rubber adhesive base, and wherein the patch comprises no more than 0.31% wgt of the asenapine in a tetrahydro form thereof after storage at 60°C for one month, and wherein a content of the at least one basic amino acid, or the pharmaceutically acceptable salt thereof, is 0.01 to 7% mass with respect to a total mass of the adhesive layer.
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, an adhesive base (see Abstract), such as a rubber adhesive base, an acrylic adhesive base, or a silicone adhesive base (see ¶[0024]), and a low molecular weight amine (id.), present at 0.5 to 40% wgt of the adhesive layer (see ¶[0049]), and a stabilizing agent, such as dibutylhydroxytoluene (see ¶[0039]. The reference does not expressly disclose a patch that comprises at least one basic amino acid, such as lysine, arginine, histidine, or pharmaceutically acceptable salts thereof. That deficiency is remedied by the teachings of US 2011/0159048 A1 to Crain, S., et al., published 30 June 2011 (“Crain ‘048”).
Crain ‘048 discloses methods and compositions for reducing Distress Dysfunction by restoring and maintaining homeostatic balance in the neurotransmitter systems underlying the Stress Response and the experience of distress and hedonic tone, wherein co-administration of Receptor Switchers with Endorphin Enhancers, such as specific cAMP PDE inhibitors, and excitatory amino acids, is an excellent formulation for restoring healthy homeostatic balance to the endogenous opioid system, and wherein the addition of Synergistic Enhancers, such as amino acids, SSRI and SNRI agents, and non-opioid analgesics, as well as Exogenous Opioids, enhances and prolongs therapeutic benefits from the practice of the methods (see Abstract), wherein synergistic treatment benefits are seen when adding Synergistic Enhancers, such as specific amino acids, to the formulations (see ¶[0017]), wherein the synergistic enhancer, when co-administered with at least one receptor switcher, reduces and/or resolves one or more symptoms, the synergistic enhancer comprising asenapine, among others, such as lysine, arginine, or histidine (see ¶[0028]), and wherein the Distress Dysfunction conditions, symptoms, and/or disorders treated by the disclosed methods include psychotic disorders (see ¶[0047]), such as schizophrenia (see ¶[0048]).
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 with a rubber, acrylic, or silicone adhesive base comprising asenapine, and a low molecular weight amine, present at 0.5 to 40% wgt of the adhesive layer, according to the teachings of Yasukochi ‘775, wherein the adhesive layer of the patch comprises amino acids, such as lysine, arginine, or histidine, in place of, or in addition to, the low molecular weight amines of Yasukochi ‘775, at 0.5 to 40% wgt of the adhesive layer. 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 Crain ‘048 to the effect that a patch comprising asenapine, combined with amino acids such as lysine, arginine, or histidine, provides enhanced effectiveness in the treatment of psychotic disorders, such as schizophrenia.
With respect to claims 9 and 10, which claims recite limitations directed to the relative amounts of the basic amino acid in the adhesive base, the Examiner notes that the cited references disclose relative loadings of the basic amino acid that are not exactly congruent with the claimed loadings. 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).”
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by claims 7 – 10 would have been obvious within the meaning of 35 USC § 103.
Obviousness-Type Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP §§ 706.02(l)(1) - 706.02(l)(3) for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 7, 9, 19, and 20 of the instant application are directed to an invention not patentably distinct from claims 1 and 10 of commonly assigned U.S. Patent No. 11,850,311 (“the ‘311 patent”), in view of Yasukochi ‘775 and Crain ‘048. Although the claims at issue are not identical, they are not patentably distinct from each other because the identified claims of the ‘311 patent are directed to a patch comprising a support layer and a pressure-sensitive adhesive layer, the adhesive layer comprising asenapine, and/or a pharmaceutically acceptable salt thereof, and a silicone-based pressure-sensitive adhesive base. The claims do not disclose a patch comprising asenapine, wherein the adhesive layer of the patch comprises at least one basic amino acid, such as lysine, arginine, or histidine. The teachings of Yasukochi ‘775 and Crain ‘048, as set forth above, remedy that deficiency.
Thus, it would have been prima facie obvious to prepare a patch comprising a support layer and a pressure-sensitive adhesive layer, the adhesive layer comprising asenapine, and/or a pharmaceutically acceptable salt thereof, and a silicone-based pressure-sensitive adhesive base, according to the enumerated claims of the ‘311 patent, wherein the adhesive layer of the patch further comprises a low molecular weight amine, present at 0.5 to 40% wgt of the adhesive layer, according to the teachings of Yasukochi ‘775, and wherein the adhesive layer of the patch comprises amino acids, such as lysine, arginine, or histidine, in place of, or in addition to, the low molecular weight amines of Yasukochi ‘775, at 0.5 to 40% wgt of the adhesive layer, as taught by Crain ‘048. 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 Crain ‘048 to the effect that a patch comprising asenapine, combined with amino acids such as lysine, arginine, or histidine, provides enhanced effectiveness in the treatment of psychotic disorders, such as schizophrenia.
The U.S. Patent and Trademark Office may not institute a derivation proceeding in the absence of a timely filed petition. The USPTO normally will not institute a derivation proceeding between applications or a patent and an application having common ownership (see 37 CFR 42.411). Commonly assigned ‘311 patent, discussed above, would be prior art to the noted claims pursuant to 35 U.S.C. 102(a)(2) if the patentably indistinct inventions were not commonly owned or deemed to be commonly owned as of the effective filing date pursuant to 35 U.S.C. 100(i) of the claimed invention.
In order for the Examiner to resolve this issue, the Applicant or patent owner can provide a statement pursuant to 35 U.S.C. § 102(b)(2)(C) and 37 CFR § 1.104(c)(4)(i) to the effect that the subject matter and the claimed invention, not later than the effective filing date of the claimed invention, were owned by the same person or subject to an obligation of assignment to the same person. Alternatively, the Applicants or the patent owner can provide a statement pursuant to 35 U.S.C. § 102(c) and 37 CFR § 1.104(c)(4)(ii) to the effect that the subject matter was developed and the claimed invention was made by or on behalf of one or more parties to a joint research agreement that was in effect on or before the effective filing date of the claimed invention, and the claimed invention was made as a result of activities undertaken within the scope of the joint research agreement; the application must also be amended to disclose the names of the parties to the joint research agreement.
A showing that the inventions were commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention will preclude a rejection under 35 U.S.C. 102 or 103 based upon the commonly assigned case. Alternatively, applicant may take action to amend or cancel claims such that the applications, or the patent and the application, no longer contain claims directed to patentably indistinct inventions.
Claims 7, 9, 19, and 20 of the instant application are directed to an invention not patentably distinct from claims 1, 7, and 8 of commonly assigned U.S. Patent No. 11,590,106 (“the ‘106 patent”), in view of Yasukochi ‘775 and Crain ‘048. Although the claims at issue are not identical, they are not patentably distinct from each other because the identified claims of the ‘106 patent are directed to a patch comprising a support and a pressure-sensitive adhesive layer that comprises asenapine and/or a pharmaceutically acceptable salt thereof, a silicone-based pressure-sensitive adhesive base, and a release control agent selected from the group consisting of oleic acid, magnesium aluminometasilicate, methacrylic acid-methacrylate copolymers, N-methyl-2-pyrrolidone, and (meth)acrylate (co)polymers, wherein the release control agent is at least one selected from the group consisting of methacrylic acid-methacrylate copolymers and N-methyl-2-pyrrolidone. The enumerated claims of the ‘106 patent do not disclose an asenapine patch wherein the adhesive layer of the patch comprises at least one basic amino acid, such as lysine, arginine, or histidine, at 0.01 mass% to 7 mass% with respect to a total mass of the adhesive layer. The teachings of Yasukochi ‘775 and Crain ‘048, as set forth above, remedy that deficiency.
Thus, it would have been prima facie obvious to prepare a patch comprising a support and a pressure-sensitive adhesive layer that comprises asenapine and/or a pharmaceutically acceptable salt thereof, a silicone-based pressure-sensitive adhesive base, and a release control agent selected from the group consisting of oleic acid, magnesium aluminometasilicate, methacrylic acid-methacrylate copolymers, N-methyl-2-pyrrolidone, and (meth)acrylate (co)polymers, and wherein the release control agent is at least one selected from the group consisting of methacrylic acid-methacrylate copolymers and N-methyl-2-pyrrolidone, according to the enumerated claims of the ‘106 patent, wherein the adhesive layer of the patch further comprises a low molecular weight amine, present at 0.5 to 40% wgt of the adhesive layer, according to the teachings of Yasukochi ‘775, and wherein the adhesive layer of the patch comprises amino acids, such as lysine, arginine, or histidine, in place of, or in addition to, the low molecular weight amines of Yasukochi ‘775, at 0.5 to 40% wgt of the adhesive layer, as taught by Crain ‘048. 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 Crain ‘048 to the effect that a patch comprising asenapine, combined with amino acids such as lysine, arginine, or histidine, provides enhanced effectiveness in the treatment of psychotic disorders, such as schizophrenia.
The U.S. Patent and Trademark Office may not institute a derivation proceeding in the absence of a timely filed petition. The USPTO normally will not institute a derivation proceeding between applications or a patent and an application having common ownership (see 37 CFR § 42.411). Commonly assigned ‘208 application, discussed above, would be prior art to the noted claims pursuant to 35 U.S.C. § 102(a)(2) if the patentably indistinct inventions were not commonly owned or deemed to be commonly owned as of the effective filing date pursuant to 35 U.S.C. § 100(i) of the claimed invention.
In order for the Examiner to resolve this issue the applicant or patent owner can provide a statement pursuant to 35 U.S.C. § 102(b)(2)(C) and 37 CFR § 1.104(c)(4)(i) to the effect that the subject matter and the claimed invention, not later than the effective filing date of the claimed invention, were owned by the same person or subject to an obligation of assignment to the same person. Alternatively, Applicants or the patent owner can provide a statement pursuant to 35 U.S.C. § 102(c) and 37 CFR § 1.104(c)(4)(ii) to the effect that the subject matter was developed and the claimed invention was made by or on behalf of one or more parties to a joint research agreement that was in effect on or before the effective filing date of the claimed invention, and the claimed invention was made as a result of activities undertaken within the scope of the joint research agreement; the application must also be amended to disclose the names of the parties to the joint research agreement.
A showing that the inventions were commonly owned or deemed to be commonly owned as of the effective filing date pursuant to 35 U.S.C. § 100(i) of the claimed invention will preclude a rejection pursuant to 35 U.S.C. §§ 102 or 103 based upon the commonly assigned case. Alternatively, Applicants may take action to amend or cancel claims such that the applications, or the patent and the application, no longer contain claims directed to patentably indistinct inventions.
Claims 7, 9, 19, and 20 of the instant application are directed to an invention not patentably distinct from claim 1 of commonly assigned U.S. Patent No. 12,343,329 (“the ‘329 patent”), in view of Yasukochi ‘775 and Crain ‘048. Although the claims at issue are not identical, they are not patentably distinct from each other because the identified claim of the ‘329 patent is directed to a patch comprising an adhesive layer on a backing, the adhesive layer comprising 3 to 10% by mass relative to the total mass of the adhesive layer of asenapine, or a pharmaceutically acceptable salt thereof, and a rubber-based adhesive base. The enumerated claim of the ‘329 patent do not disclose an asenapine patch wherein the adhesive layer of the patch comprises at least one basic amino acid, such as lysine, arginine, or histidine, at 0.01 mass% to 7 mass% with respect to a total mass of the adhesive layer. The teachings of Yasukochi ‘775 and Crain ‘048, as set forth above, remedy that deficiency.
Thus, it would have been prima facie obvious to prepare a patch comprising an adhesive layer on a backing, the adhesive layer comprising 3 to 10% by mass relative to the total mass of the adhesive layer of asenapine, or a pharmaceutically acceptable salt thereof, and a rubber-based adhesive base, according to the claim of the ‘329 patent, wherein the adhesive layer of the patch further comprises a low molecular weight amine, present at 0.5 to 40% wgt of the adhesive layer, according to the teachings of Yasukochi ‘775, and wherein the adhesive layer of the patch comprises amino acids, such as lysine, arginine, or histidine, in place of, or in addition to, the low molecular weight amines of Yasukochi ‘775, at 0.5 to 40% wgt of the adhesive layer, as taught by Crain ‘048. 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 Crain ‘048 to the effect that a patch comprising asenapine, combined with amino acids such as lysine, arginine, or histidine, provides enhanced effectiveness in the treatment of psychotic disorders, such as schizophrenia.
The U.S. Patent and Trademark Office may not institute a derivation proceeding in the absence of a timely filed petition. The USPTO normally will not institute a derivation proceeding between applications or a patent and an application having common ownership (see 37 CFR § 42.411). Commonly assigned ‘208 application, discussed above, would be prior art to the noted claims pursuant to 35 U.S.C. § 102(a)(2) if the patentably indistinct inventions were not commonly owned or deemed to be commonly owned as of the effective filing date pursuant to 35 U.S.C. § 100(i) of the claimed invention.
In order for the Examiner to resolve this issue the applicant or patent owner can provide a statement pursuant to 35 U.S.C. § 102(b)(2)(C) and 37 CFR § 1.104(c)(4)(i) to the effect that the subject matter and the claimed invention, not later than the effective filing date of the claimed invention, were owned by the same person or subject to an obligation of assignment to the same person. Alternatively, Applicants or the patent owner can provide a statement pursuant to 35 U.S.C. § 102(c) and 37 CFR § 1.104(c)(4)(ii) to the effect that the subject matter was developed and the claimed invention was made by or on behalf of one or more parties to a joint research agreement that was in effect on or before the effective filing date of the claimed invention, and the claimed invention was made as a result of activities undertaken within the scope of the joint research agreement; the application must also be amended to disclose the names of the parties to the joint research agreement.
A showing that the inventions were commonly owned or deemed to be commonly owned as of the effective filing date pursuant to 35 U.S.C. § 100(i) of the claimed invention will preclude a rejection pursuant to 35 U.S.C. §§ 102 or 103 based upon the commonly assigned case. Alternatively, Applicants may take action to amend or cancel claims such that the applications, or the patent and the application, no longer contain claims directed to patentably indistinct inventions.
Response to Applicants’ Arguments
The Examiner has considered the arguments submitted by Applicants in the Response filed 5 December 2025 but does not find them persuasive. With respect to the limitations added to amended claims 7 and 19, directed to the stability of the active ingredient, asenapine, in the transdermal dosage forms of the claimed invention, where that stability is indicated by the quantities of degradation products of asenapine in the dosage forms, Applicants argue that alleged “synergistic effects” arising from the inclusion of basic amino acids, such as lysine, arginine, or histidine in the asenapine patch “are not recognized, known, nor taught by Yasukochi or Crain, whether taken alone or in combination.” The Examiner does not disagree, nor does the Examiner take issue with the apparent effectiveness of the inclusion of basic amino acids in the patches to minimize the degradation of the active, as supported by the specification. However, neither the utility, nor recognition of synergy are sufficient, without more, to establish patentability. More specifically, the fact that Applicants have recognized another advantage [synergy/stability] which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). In this regard, Applicants are reminded that the invention as claimed is directed to a composition of matter, and that, as a consequence, the reasons for combining the teachings of cited references, are not necessarily controlling to the patentability of the compositions, as claimed. The reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See, e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006).
In looking more closely at, for example, claim 7, directed, as stated above, to a composition of matter, the claim recites compositional limitations directed to an adhesive base comprising asenapine, a rubber adhesive, and lysine, arginine, or histidine; the only structural limitation recited in the claim is that the adhesive layer is “on a backing.” The Examiner notes that the compositional limitations do not recite any specific quantitative loadings, or ranges of loadings, for the components of the patch. In comparison, the art cited in the above rejection discloses a patch comprising a backing layer and an adhesive layer laminated on one side of the backing, wherein the adhesive layer comprises asenapine, a rubber adhesive base, a low molecular weight amine, and a stabilizing agent (Yasukochi ‘775), and a combination of asenapine and lysine, arginine, or histidine (Crain ‘048). It is, therefore, the Examiner’s position that an asenapine patch, according to the cited art, comprising the active and a basic amino acid, in addition to or in pace of the low molecular weight amine of Yasukochi ‘775, in a rubber adhesive base, would necessarily provide the level of stability for asenapine that would read on the newly recite limitations, rendering them obvious.
Applicants also argue that “the presently cited prior art provides no evidence of any solution whatsoever to this problem [degradation of asenapine]. However, as also noted above, that is not controlling on the issue of patentability of a composition of matter. See Ex parte Obiaya. The same logic also applies to Applicants’ assertion that their invention satisfies a long-felt need and unsatisfied need to suppress degradation of the active. Their asserted need does not need to coincide with the motivation to combine the teachings of the prior art references, which motivation is supplied by the teachings of Crain ‘048 that compositions comprising asenapine, combined with amino acids such as lysine, arginine, or histidine, provide enhanced effectiveness in the treatment of psychotic disorders that are likely to cause dysfunctional emotional and physical distress that interferes with the individual's quality of life and functioning, the clinical effect achieved by restoring and maintaining homeostatic balance in neurotransmitter systems (see Crain ‘048, Abstract).
Consequently, based on the above discussion, Applicants’ arguments are unpersuasive and claims 7, 9, 19, and 20 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