DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
Claims 1 and 3-16 are pending.
Claims 8-15 are withdrawn from consideration as directed to non-elected inventions.
Claims 1, 3-7, and 16 are presented for examination and rejected as set forth below.
Claim Interpretation
Applicants claims are directed to patch compositions having an adhesive layer containing each of: at least one amide which includes N-methyl-2-pyrrolidone or an alcohol including either of alkyl lactate and propylene glycol monocaprylate, combined with the active agent 3-[(3R*,4R*) -3-)dimethylaminomethyl)tetrahyropyran-4-yl]phenol, where the acid, amide, or alcohol is present in concentrations of at least 50% of the concentration of the active agent. Claim 3 limits the concentration of the active in the composition. Claim 4-6 specify the inclusion of thermoplastic polymers, ultimately requiring the presence of a combination of styrene-isoprene-styrene copolymers and styrene-isoprene copolymers. Claim 7 indicates the patch of Claim 1 is for use in a variety of different treatments: applicants are reminded that a recitation of an intended use will not limit the scope of the claim because it merely defines a context in which the invention may operate. Boehringer Ingelheim Vetmedica, Inc. v. Schering-Plough Corp., 320 F.3d 1339, 1345 (Fed. Cir. 2003). Claim 16 requires that each of an amide and alcohol be present in the composition.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which 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, 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 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 under 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, 3-5, 7, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Suzuki (WO2019/156074(of record: all references are to the 2021/0040057 U.S. PGPub., serving as an English translation representing the National Stage entry of the International application), in view of Stinchcomb (WO2011/123866), Hammes (WO2020/212596), and Crain (U.S. PGPub. 2010/0203084).
Suzuki describes transdermal patch compositions containing the claimed 3-[(3R*,4R*)-3-)dimethylaminomethyl) tetrahyropyran-4-yl]phenol in combination with any of a variety of additional components including, as ointment bases, fatty alcohols such as stearyl or cetyl alcohol, pressure-sensitive adhesives including the styrene-isoprene-styrene block copolymers of Claims 4 and 5, plasticizers, and optionally permeation enhancers. [0124-32]. A particular embodiment contains between 1-10% of the compound, leaving up to 90% of the composition to constitute any of the remaining components described as usefully included in the patch compositions suggested. [0137-42].
However, Suzuki does not describe the inclusion of N-methyl-2-pyrrolidone, alkyl lactate, or propylene glycol monocaprylate
Stinchcomb also describes transdermal drug delivery patches which describes styrene-isoprene-styrene block copolymers, as well as diblock analogs thereof, as representative of standard pressure-sensitive adhesives known in the art, employed in any of a wide range of concentrations. [0066-67; 0069]. Stinchcomb also indicates these compositions may incorporate commonly used penetration enhancers known in the art including monoglycerides of C8-22 fatty acids and N-alkylpyrrolidones. [0095]. Stinchcomb indicates these penetrations enhancers are commonly found in transdermal drug delivery compositions in concentrations of between 0.1-15%. [0096].
Crain teaches that N-methylpyrrolidone, synonymous with the instantly claimed N-methyl-2-pyrrolidone, is known to be useful as a permeation enhancer for transdermal pain treatment patches. [0054].
Hammes indicates that at the time of the instant applications filing, propylene glycol monocaprylate was known to be useful as a transdermal penetration enhancer. (Pg.8).
The art available at the time applicants filed the instant application therefore not only teaches the skilled artisan to provide the claimed 3-[(3R*,4R*)-3)dimethylaminomethyl) tetrahyropyran-4-yl]phenol as a transdermal drug delivery patch, in combination with not only the styrene based thermoplastic elastomers of Claims 4 and 5, but also including permeation enhancers known in the art. The art also establishes that the N-methylpyrrolidone and propylene glycol monocaprylate of the present claims were at the time known to act as permeation enhancers for transdermal drug delivery patches employing styrene-isoprene-styrene block copolymers as the pressure-sensitive adhesives, the combination and inclusion of therefore being prima facie obvious per the teachings of Stinchcomb and Suzuki. See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945)( Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use), see also In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980)(Generally, it is prima facie obvious to combine two compositions, each of which is taught by the prior art to be useful for same purpose, in order to form a third composition to be used for the very same purpose). The art available also suggests incorporating the active agent in concentrations of 10% of the patch, while also teaching that the permeation enhancers can be present in concentrations of 15% of the composition, establishing that the ratio of fatty acid to active agent required by the claims was in fact suggested by the art. It must be remembered that “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious.” KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976)). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious,” the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR at 1741. The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742.
Consistent with this reasoning, it would have been prima facie obvious to have combined the claimed active agent with styrene-isoprene-styrene copolymers as a pressure sensitive adhesive and N-methylpyrrolidone and propylene glycol monocaprylate as permeation enhancers in concentrations addressing the limitations of the present claims to arrive at compositions “yielding no more than one would expect from such an arrangement.”
Claims 1, 3-7, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Suzuki, Stinchcomb, Crain, and Hammes as applied to claims 1, 3-5, 7, and 16 above, and further in view of Gibert (F.X. Gibert, et al, Rheological Properties of Hot Melt Pressure-Sensitive Adhesives Based on Styrene—Isoprene Copolymers. Part 1: A Rheological Model for [sis-si] formulations, 79 J Adhesion 825 (2003)).
Suzuki and Stinchcomb, discussed in greater detail above, suggest transdermal drug delivery patches combining styrene-isoprene-styrene copolymer pressure sensitive adhesives with up to 15% of the composition representing N-methylpyrrolidone and propylene glycol monocaprylate as permeation enhancers and, as the active agent representing 10% or less by weight of the composition the claimed 3-[(3R*,4R*)-3)dimethylaminomethyl) tetrahyropyran-4-yl]phenol addressing the limitations of the instant claims.
However, neither Suzuki, Stinchcomb, Crain, nor Hammes suggest the combination of styrene-isoprene-styrene copolymer and styrene-isoprene copolymers as the pressure sensitive adhesive.
This is cured by the teachings of Gibert, which establishes that at the time the present application was filed, combinations of styrene-isoprene-styrene copolymers and styrene-isoprene copolymers were known to be useful as pressure-sensitive adhesives.
Because Stinchcomb explicitly states that each of styrene-isoprene-styrene copolymers and diblock analogs thereof are acceptable pressure-sensitive adhesives for use in transdermal drug delivery patches, and the art also establishes that combinations of styrene-isoprene-styrene copolymers and styrene-isoprene copolymers were known to be useful as pressure-sensitive adhesives. The use of such a pressure sensitive adhesive in the compositions suggested by the teachings of Suzuki and Stinchcomb appears little more than a skilled artisan’s selection of a known material for incorporation into a composition, based on its recognized suitability for its intended use. See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).
Response to Arguments
Applicant's arguments filed 7 November 2025 concerning the obviousness of the amended claims have been fully considered but they are not persuasive in view of the references added to address newly added limitations concerning the identity of the components (b) present in the composition. Applicants position that the Suzuki reference only teaches a concentration of the active agent relative to the patch as a whole and not in regard to the amount of the component (b) present in the composition is accurate, so far as that goes; however, the Examiner has not asserted that Suzuki, considered alone, addresses the claimed ratio of at least 50 parts component (b) to 100 parts component (a). The Examiner has relied on the fact that Suzuki teaches that the active component (a) may be present in a concentration of 10%, combined with the Stinchcomb teaching that permeation enhancers such as monoglycerides of C8-22 fatty acids and N-alkylpyrrolidones may be present in concentrations as high as 15%. Combined with the teachings of Crain and Hammes, indicating that the propylene glycol monocaprylate and N-methyl-2-pyrrolidone are species of the monoglycerides of C8-22 fatty acids and N-alkylpyrrolidones taught by Stinchcomb to conclude that a ratio of 100 parts component (a) and 150 parts component (b), thereby addressing the limitations of the claims. Applicants arguments that Stinchcomb fails to teach the claimed ratio is unpersuasive for the same reason: the Examiner has not asserted that the ratio is itself taught by either of Suzuki or Stinchcomb, but rather the combined teachings of Suzuki and Stinchcomb render such a ratio prima facie obvious. Finally, the Examiner points out that Stinchcomb is not in fact limited to common fatty acids and aliphatic alcohols as penetration enhancers, as Stinchcomb specifically identifies each of monoglycerides of C8-22 fatty acids and N-alkylpyrrolidones as among a non-limiting list of exemplary permeation enhancers. [0095].
Applicants assertion that Gilbert fails to address the alleged deficiencies in the Examiner’s prima facie case is unpersuasive owing to the fact that Gilbert was relied on solely to address limitations of a dependent claim, rather than establish an art-recognized ratio of active to penetration enhancer in transdermal drug delivery systems where the penetration enhancer is present in the composition in an amount of at least 50% of the concentration of the active.
For at least these reasons, applicants argument are unpersuasive.
Conclusion
No Claims are allowable.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN M BASQUILL whose telephone number is (571)270-5862. The examiner can normally be reached Monday through Thursday, 5:30 AM to 4 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached at (571) 272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SEAN M BASQUILL/Primary Examiner, Art Unit 1614