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 .
Priority
This Application filed on 10/28/2022 is a 371 of PCT/US21/29719 filed on 04/28/2021 which has a PRO 63/139,224 filed 01/19/2021 on 12/11/2003, and PRO 63/019,042 filed on 05/01/2020.
Information Disclosure Statement
No new information disclosure statement(s) (IDS) filed.
DETAILED ACTION
The Office Action is in response to the Applicant's reply filed March 30, 2026 to the office action made on December 10, 2025.
The arguments over the rejection of claim 34 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph is persuasive. The rejection is herewith withdrawn.
The rejection of claims 31-45, 47-49, and 84 under 35 U.S.C. 103(a) as being unpatentable over Yacoby-Zeevi et al. (WO 2016/042413 A1) in view of Akazawa et al. (JP WO2012029097 A1) is not persuasive. The rejection is herewith maintained.
Applicant argues “ neither Yacoby-Zeevi nor Akazawa discloses levulinic acid "in an amount of 0% to 5% w/w." As summarized in the above table, the Office failed to identify disclosure of the limitation from Yacoby-Zeevi, and explicitly stated that Yacoby-Zeevi does not disclose "a penetration enhancer in 3% w/w, nor does the reference teach the specific levulinic acid." Office Action at pages 5-6. The Office relied on Akazawa for the limitation. However, while the Office identified disclosure of levulinic acid in Akazawa, it failed to identify any teaching or suggestion related to the amount of levulinic acid i.e., "an amount of 0% to 5% w/w." “ The Examiner points out that Yacoby-Zeevi does teach penetration enhancers within the range of independent claim 1 “in an amount of 0% to 5% w/w.”
Applicant states levulinic acid is in a laundry list of penetration enhancers of the prior art. The Examiner states the motivation to use levulinic acid comes from the teaching that it is a known penetration enhancer used in a transdermal composition.
Applicant argues opipramol and lidocaine do not have the same structure or function and are used for different purposes, therefore, there would be no motivation to modify the formulation. The Examiner’s contention is that opipramol is indicated for pain and pain related disorders according to Yacoby-Zeevi et al. and lidocaine is used for the same. Applicant has not provided any evidence other than stating that the structures are different for the argument that lidocaine would not work in Yacoby-Zeevi et al.’s transdermal formulation. The argument is not persuasive.
The rejections are as below and based on amendments made to the claims:
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.
Claims 31-35, 37-45, 47-49, and 84 are rejected under 35 U.S.C. 103 as being unpatentable over Yacoby-Zeevi et al. (WO 2016/042413 A1) in view of Akazawa et al. (JP WO2012029097 A1).
Yacoby-Zeevi et al. teach transdermal compositions include an active agent; one or more plasticizers; one or more penetration enhancers in about 5% to about 25% w/w ; a pressure-sensitive adhesive (PSA); and may include one or more hydrophilic polymers.(see Abstract). The reference teaches the PSA is selected from the group consisting of Duro-Tak® 387-2516/87-2516, Duro-Tak® 87-2852, Duro- Tak® 387-2510/87-2510, Gelva® GMS 788, Duro-Tak® 87-9301, Duro-Tak® 87-202A, and Duro-Tak® 87-4098, or a combination thereof in 30-90%, 35-85%, 40-80%, or 40-75% ; polyethylene glycol ether is selected polyethylene glycol dodecyl ether (Brij® 30); fatty acid or fatty acid ester is selected from isopropyl myristate (IPM), isopropyl palmitate and combinations thereof in 2-25%, 2.5-20%, 2.5-15%, or 2.5-10%. (see claims 7 and 13; [0098] Table A-2). The active opipramol is in 1-50% of the composition; examples include 2.5-20% (Table A-4). The reference teaches rapid delivery of the active [00160-6]. The transdermal delivery device comprises: a. an inert layer detachable when used; b. at least one adhesive layer comprising a transdermal drug composition of any one of claims 1-44, wherein the adhesive layer is directly affixed to a surface of the inert layer; and c. a backing layer, coated over the adhesive layer. (see claim 45). The reference teaches a transdermal patch that includes a disclosed composition is contemplated, and may include a single layer adhesive patch, a multi-layer adhesive patch, a reservoir patch, a matrix patch, a microneedle patch, or an iontophoretic patch, which typically requires applying a direct current. In some embodiments, contemplated transdermal patches may be adapted for continuous release. [0045]
With respect Claims 47-48, to the adhesive the reference teaches compositions “may be used to form the matrix (drug reservoir) component of a transdermal patch or be used as a separate in-line adhesive layer. In either application, the composition may define the basal surface (i.e. the surface that contacts the skin) of the patch when the patch is in use. As indicated, when the composition is used to form the matrix, the drug is incorporated into the adhesive before crosslinking. When the composition forms an in-line basal adhesive layer, the drug may be incorporated into the layer either before crosslinking or by equilibration after the patch has been assembled.” Furthermore, the transdermal delivery comprises: a. an inert layer detachable when used; b. at least one adhesive layer comprising a transdermal drug composition as described above, wherein the adhesive layer is directly affixed to a surface of the inert layer; and c. a backing layer, coated over the adhesive layer.
While the prior art teaches the active opipramol useful for CNS disorder is selected from the group consisting of epilepsy, Parkinson's disease, Alzheimer's disease, depression, restless legs syndrome, pain, schizophrenia, neurodegeneration, dementia, and migraine, and a penetration enhancer in about 5% w/w; the reference does not teach lidocaine as claimed, a penetration enhancer in 3% w/w/ nor does the reference teach the specific levulinic acid.
Akazawa et al. teaches a transdermal absorption preparation comprising a pressure-sensitive adhesive layer, lidocaine (relieves pain) in 1 to 10% by weight, particularly preferably 3 to 7% by weight and an organic acid. (abstract) The “organic acid” are alkoxy group or acyl group, such as glycolic acid, lactic acid, methoxyacetic acid, mandelic acid, levulinic acid, 3-hydroxybutyric acid and the like, and the like. The transdermal absorbability can be controlled with the addiction of organic acid salt. (page 2 para. 8)
It would have been obvious to one of ordinary skill in the art to interchange an active used to treat pain, such as opipramol for lidocaine and to add the organic acid levulinic. The motivation to interchange the actives and to add the organic acid levulinic is because both are useful in treating pain and Akazawa et al. teaches transdermal absorbability can be controlled with the addiction of organic acid salt. Therefore, an ordinary skilled artisan would have had a reasonable expectation of successfully achieving similar efficacy and results.
Claims 47-49 recite the intended use of a device. Specifically, “suitable for providing rapid local anesthesia” and claim 49 in entirety. If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020) (The court found that the preamble in one patent’s claim is limiting but is not in a related patent); Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See also Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir. 1997) (“where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation”); Kropa v. Robie, 187 F.2d at 152, 88 USPQ2d at 480-81 (preamble is not a limitation where claim is directed to a product and the preamble merely recites a property inherent in an old product defined by the remainder of the claim); STX LLC. v. Brine, 211 F.3d 588, 591, 54 USPQ2d 1347, 1350 (Fed. Cir. 2000) (holding that the preamble phrase “which provides improved playing and handling characteristics” in a claim drawn to a head for a lacrosse stick was not a claim limitation). Compare Jansen v. Rexall Sundown, Inc., 342 F.3d 1329, 1333-34, 68 USPQ2d 1154, 1158 (Fed. Cir. 2003)
Conclusion
No claims are allowed.
The arguments are not persuasive and the rejection is made FINAL.
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 extension fee 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.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAYLA SOROUSH whose telephone number is (571)272-5008. The examiner can normally be reached on Monday thru Friday; 8:30 AM to 5:00 PM EST.
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/LAYLA SOROUSH/Primary Examiner, Art Unit 1622
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