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 .
DETAILED ACTION
The Office Action is in response to the Applicant's reply filed September 29, 2025 to the restriction requirement made on July 30, 2025.
Applicant’s election of Group I, claims 31-45, 47-49 and 84, in the reply filed on September 29, 2025, and DURO-TAK 87-4098, levulinic acid, and polyethylene glycol dodecyl ether without traverse is acknowledged.
The restriction requirement is deemed proper and made FINAL.
Claim 46 is withdrawn from further consideration pursuant to 37 C.F.R. 1.142(b), as being drawn to non-elected subject matter. The claims corresponding to the elected subject matter are 31-45, 47-49 and 84 and are herein acted on the merits.
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
The information disclosure statement(s) (IDS) filed on 1/31/23, 6/21/24, and 10/13/25 is in compliance with the provisions of S7 CFR 1.97. Accordingly, the IDS is being considered by the Examiner.
The rejections are as below:
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 34 contains the trademark/trade name the pressure-sensitive adhesive DURO-TAK 87-4098, wherein “DURO-TAK” is a registered US trademark. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112, second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe an pressure-sensitive adhesive, accordingly, the identification/description is indefinite.
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 31-45, 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.
Contact Information
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/LAYLA SOROUSH/Primary Examiner, Art Unit 1622