DETAILED ACTION
The receipt is acknowledged of applicants’ amendment and request for RCE filed 10/27/2025.
Claims 1-20 are pending.
Claims 8-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions II and III, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 02/03/2025.
Claims 1-7 are subject of this office 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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/27/2025 has been entered.
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 1-7 are rejected under 35 U.S.C. 103 as being unpatentable over Goldberg et al. (WO 2021/163238, previously provided) in view of Witowski et al. (US 2021/0346347, previously cited on PTO 892), Plakogiannis et al. (US 2023/0059204, IDS filed 03/27/2025), and the article by Wang et al. (“Plant-exosome-like nanoparticles as biological shuttles for transdermal drug delivery”, currently provided).
Applicant Claims
Claim 1 is directed to a transdermal delivery system, comprising:
a. an absorbent material in the transdermal delivery system including
a menthol composition consisting essentially of: menthol and a menthol stabilizer
compound including methyl 10-undecenoate; and optionally a solvent where the
menthol and menthol stabilizer compound are combined before being added the to the absorbent material;
an effective amount of a compound for treating drug addiction;
a carrier solvent;
an absorbent polymer;
exosomes; and
a surfactant.
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
Goldberg teaches transdermal delivery system comprising absorbent material comprising cannabinoid, menthol, menthol stabilizer, superabsorbent polymer, carrier solvent, surfactant and additional active agent (abstract; ¶¶ 0009,0037, 0048, 0068; claims). Cannabinoid includes full spectrum hemp oil (¶¶ 0051, 0054). Menthol is stabilized by menthol stabilizer that are premixed before it is added to the other components of the transdermal composition (¶¶ 0059-0061). Menthol stabilizer include 10-undecenoic acid and its salts (claims 7, 29). Examples of carrier solvents are coconut oil, olive oil, castor oil, canola oil and corn oil (¶¶ 0063, 0065).
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.012)
While Goldberg teaches additional active agent in the transdermal composition, the reference does not explicitly teach compounds for treating drug addiction as claimed by claim 1. Goldberg does not teach exosomes in the transdermal composition as claimed by claim 1.
Witowski teaches transdermal formulation comprising psilocybin as an active agent to treat abuse disease, e.g. opioid addiction. The transdermal formulation preferably is a transdermal patch (abstract; ¶¶ 0017, 0025-0028, 0075, 0077, 0083-0085, 0105, 0137, 0138, 0142). The transdermal formulation can be in the form of matrix type, that read on absorbent material. The matrix comprises carbomer, acrylate, polysaccharide, carrageenan (¶ 0099) all disclosed and used by applicants as absorbent polymer material and super absorbents polymers in paragraph [0095] of the current published application. The transdermal formulation comprises ingredients that enhances delivery of active agent through the skin including terpenes, e.g. menthol, triglycerides, castor oil, olive oil, coconut oil, mineral oils, shea butter and petrolatum (¶¶ 0087, 0099) all claimed by applicants as carrier solvent. The formulation comprises surfactant (¶ 0088). The transdermal formulation can further comprise additional active agent, e.g. other ingredients to treat opioid addition (¶ 0141).
Plakogiannis teaches transdermal administration of cannabinoid and psilocybin to treat opioid addiction without causing hallucinogenic effect in the patient. The transdermal administration is in the form of a transdermal patch (abstract; ¶¶ 0041, 0043, 0045, 0046, 0050-0053, 0088-0091, 0093, 0141, 0175-0183). The patch can be matrix type comprising polymer matrix (¶¶ 0069, 0073, 0079). The polymer matrix comprises polyacrylate, carbomer, polysaccharides, gelatin, carrageenan, all disclosed and used by applicants as absorbent and superabsorbent polymer in paragraph [0095] of the current published application. The matrix comprises menthol, surfactant, and further comprises triglyceride, petrolatum, and mineral oils, which claimed and used by applicants as carrier solvents (¶¶ 0079-0084, 169-0174, 0339, 0341, 0347, 0348; claims 28 and 29).
Wang teaches exosomes are emerging transdermal drug delivery vehicles with high deformability and excellent permeability, which can be used to deliver various drug molecules and increase the transdermal and dermal retention of drugs, improving the local efficacy and drug delivery compliance. The reference further teaches plant exosomes that enjoy the perks of being undetected by the human immune system (see the entire document, and in particular: abstract; page 2).
Finding of Prima Facie Obviousness Rational and Motivation
(MPEP §2142-2143)
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the present invention to provide transdermal patch taught by Goldberg comprising cannabinoid and additional active agent, and use psilocybin taught by Witowski and Plakogiannis as additional active agent. One would have been motivated to do so because Witowski teaches psilocybin is an active agent that treats abuse disease, e.g. opioid addiction, and because Plakogiannis teaches administration of cannabinoid and psilocybin treats opioid addiction without causing hallucinogenic effect in the patient. One would reasonably expect formulating transdermal formulation comprising cannabinoids and psilocybin, along with the other ingredients that effectively treats opioid addiction without causing hallucinogenic effect in the patient.
Further, one having ordinary skill in the art would have used exosomes taught by Wang to the transdermal composition taught by the combination of Goldberg, Witowski and Plakogiannis, because Wang teaches exosomes are emerging transdermal drug delivery vehicles with high deformability and excellent permeability, improving the local efficacy and drug delivery compliance, even including plant exosomes that enjoy the perks of being undetected by the human immune system.
All the limitations of claim 1 are taught by combination of the cited references.
Regarding cannabinoid claimed by claim 2, it is taught by Goldberg and Plakogiannis,
Regarding superabsorbent polymers claimed by claim 3, they are taught by Goldberg, Witowski and Plakogiannis.
Regarding carrier solvents claimed by claim 4, they are taught by Goldberg, Witowski and Plakogiannis.
Regarding full spectrum herm oil claimed by claim 5, it is taught by Goldberg.
Regarding psilocybin claimed by claim 6, it is taught by both Witowski and Plakogiannis.
Regarding treating drug addiction as claimed by claim 7, it is taught by Witowski, Plakogiannis.
Absent any evidence to the contrary, and based upon the teachings of the prior art, there would have been a reasonable expectation of success in practicing the instantly claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the present invention.
Minor Informalities
Claim 1 recites “……the system comprising: a. absorbent material…..”, however while the claim recite component “a”, there is not more components, e.g. “b”.
Response to Arguments
Applicant's arguments filed 10/27/2025 have been fully considered but they are not persuasive.
Applicants argue that neither Sun nor any of the other cited references teach or suggest exosomes in a transdermal delivery system. Claim 1 includes transdermal delivery system both in the preamble and in the body of the claim. Sun refers to exosomes in intravenous injections, while the present invention exosomes are in transdermal delivery system.
Note that Sun reference is no longer relied upon for rejecting the claims. It is argued that all the currently cited references are directed to transdermal drug delivery system. Wang teaches transdermal drug delivery using exosomes.
Applicants argue that, regarding combining references, the Examiner must “identify a reason that would have prompted a person of ordinary skill in the art in the relevant field to combine the elements in the way the claimed new invention does”.
In response to this argument, applicant’s attention is directed to the scope of the claims that are directed to a composition, and all the elements of the claimed composition are taught by combination of the cited references. Motivation to combine the references exists, even if different from what applicants had done, and reasonable expectation to achieve the present invention was presented. It should be noted that the motivation to combine references can be different from the ones set forth by Applicant. That is, as long as motivation exists to combine the elements, the problem to be solved does not have to involve the same reason. As such, the examiner respectfully submits that there is motivation to combine the cited references to achieve the present invention as set forth in this office action.
Applicants argue that the Examiner cannot use the claimed invention as an instruction manual or template to piece together the teachings of the prior art so that the claimed invention is obvious. In re Fritch, 972 F.2d 1260, 1266 (Fed.Cir.1992). "When prior art references require selective combination by the court to render obvious a subsequent invention, there must be some reason for the combination other than the hindsight gleaned from the invention itself." Interconnect Planning Corp. v. Feil, 774 F.2d 1132, 1143 (Fed.Cir.1985). Furthermore, the Examiner cannot use the claimed invention as an instruction manual or template to piece together the teachings of the prior art so that the claimed invention is obvious. In re Fritch, 972 F.2d at 1266. The Examiner must provide some reason for the combination other than the hindsight gleaned from the claimed subject matter itself. Interconnect Planning Corp. v. Feil, 774 F.2d at 1143.
In response to this argument, it is argued that the examiner completely relied on the cited references to formulate the rejection, and not on applicant’s disclosure, and motivation to combine the references exists and reasonable expectation to achieve the present invention has provided. It must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
MPEP § 904 stated that in determining the scope and content of the prior art, Office personnel must first obtain a thorough understanding of the invention disclosed and claimed in the application under examination by reading the specification, including the claims, to understand what the applicant has invented. The scope of the claimed invention must be clearly determined by giving the claims the "broadest reasonable interpretation consistent with the specification." See Phillips v. AWH Corp., 415 F.3d 1303, 1316, 75 USPQ2d 1321, 1329 (Fed. Cir. 2005) and MPEP § 2111. Once the scope of the claimed invention is determined, Office personnel must then determine what to search for and where to search. Therefore, referring to the specification to understand the invention for search purpose is permitted and acceptable by the patent office.
Applicants argue that dependent claims 2-7 ultimately depend on claim 1. Since claim 1 is not obvious, claims 2-7 are not obvious as well. In re Fine, 837 F.2d 1071, 1076 (Fed. Cir. 1988); M.P.E.P. §2143.03. Also, claims 2-7 are patentable not only because the dependent claims ultimately depend from independent claim 1 which Applicants assert is allowable over the cited references but also because of the additional recitations contained in the dependent claims.
In response to this argument, it is argued that claim 1 is not allowable for the reasons set forth in this office action. All the limitations of dependent claims 2-7 are taught either explicitly or implicitly by the cited references. Therefore claims 2-7 are not allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Isis A D Ghali whose telephone number is (571)272-0595. The examiner can normally be reached Monday through Friday, 8:30 AM to 5:00 PM EST.
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/ISIS A GHALI/Primary Examiner, Art Unit 1611 /I.G./