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 .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 63/417,209, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The prior application does not disclose a vegetable-based inkjet ink; wherein the at least one cannabinoid is present in a quantity of at least about 10mg; wherein the at least one cannabinoid is about 0.1-15% weight of the drug-in-adhesive composition or of the nanoemulsion; wherein about 50-90% weight of the nanoemulsion is an aqueous phase; wherein the nanoemulsion further comprises a carrier oil and a surfactant; or wherein the drug-in-adhesive composition further comprises a water-based, pressure sensitive adhesive, in amounts of about 50-80% weight of the composition, and a skin penetration enhancer that is oleic acid. Accordingly, claims 2-3 and 5-11 are not entitled to the benefit of the prior application.
Claim Rejections - 35 USC § 103
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.
Claims 1-8 are rejected under 35 U.S.C. 103 as being unpatentable over Lorenz et al. (US 2018/0360739 A1, 12/20/2018) (hereinafter Lorenz).
Lorenz discloses non-invasive application of a composition comprising one or more bioactive agents (abs) in the form of an emulsion ([0032]), said bioactive include cannabidiol (CBD) and tetrahydrocannabinol (THC) ([0050]), provided in nanoparticles to protect from degradation and premature elimination ([0035]). The bioactive agents are present at amounts of 0.0001% to 100% ([0034]), and all levels of one or more organic solvents including water ([0036]). The non-invasive application may comprise one or more body ink, applied in the form of a temporary tattoo ([0019]-[0020]) as an application film ([0066]). The body ink includes vegetable dyes (i.e. instantly claimed vegetable-based ink) ([0065]). The temporary tattoo comprises a bioadhesive surface, bioactive drug and ink component, a protective water resistant layer, a soluble slip coating layer, and a releasably applied substrate (claim 15), optionally comprising a stencil layer comprising an image design ([0071]). Said bioactive delivering application is put face down on the skin; a saturated cloth or a moist towelette comprising water is applied over the application, releasing the substrate and transferring the application to the skin ([0074]). The composition may further comprise oils ([0039]), surfactants ([0040]), and/or oleic acid ([0054]).
Thus, the prior art discloses a temporary tattoo ([0020]) comprising a release liner, a drug and bioadhesive containing composition comprising an emulsion ([0032]) of CBD and/or THC (i.e. instantly claimed plurality of cannabinoids) ([0050]), in the form of nanoparticles (i.e. instantly claimed nanoemulsion) ([0035]), with vegetable dyes as body ink ([0065]), a design attached to the bioactive layer ([0071]), and a releasably applied substrate that detaches upon exposure to water ([0074], claim 15), providing a temporary tattoo as instantly claimed.
The prior art is not anticipatory insofar as this combination must be selected from various lists/locations in the reference. It would have been obvious, however, to make the combination since all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. See MPEP § 2143 (I)(A).
Regarding claims 3, 5 and 6 reciting an amount of the at least one cannabinoid, it would have been obvious to one of ordinary skill in the art to have selected an amount of cannabinoids from the disclosed range of 0.0001-100%, which appears to overlap the instantly claimed amounts in weight % or mg. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP § 2144.05(I). Moreover, in any case, the selection of appropriate weight percentages would appear to require no more than routine testing on the part of the skilled artisan, and so alternatively it would have been obvious to determine workable ranges to arrive at the claimed amounts in mg. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." See MPEP § 2144.05(II)(A).
Regarding claim 7 reciting an amount of aqueous phase, it would have been obvious to one of ordinary skill in the art to have selected an amount of one or more organic solvents (e.g., water) from the disclosed range of “all levels of one or more organic solvents,” which appears to overlap the instantly claimed ranges (i.e. about 50 to about 90 weight %). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP § 2144.05(I).
Regarding claim 8, as discussed above, Lorenz discloses wherein the composition may further comprise oils and surfactants.
Claims 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Lorenz et al. (US 2018/0360739 A1, 12/20/2018) (hereinafter Lorenz), further in view of Sunkel et al. (US 2015/0297471 A1, 10/22/2015) (hereinafter Sunkel).
The disclosure of Lorenz is discussed in detail above, and differs from the instant claims insofar as not explicitly disclosing wherein the adhesive is a water-based, pressure sensitive adhesive.
However, Sunkel discloses adhesive materials known for topical use on skin, including those water based pressure sensitive adhesives commonly used for temporary tattoos. Such adhesive may be present at an amount of at least 50%, but typically less than 100% ([0076]).
Accordingly, it would have been obvious to one of ordinary skill in the art to have included a water-based, pressure sensitive adhesive, in an amount of 50-100% of composition, in the application of Lorenz since it is a known and effective adhesive and amount commonly used for temporary tattoos as taught by Sunkel.
Citation of Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Cartagena (US 2020/0155360 A1, 05/21/2020), directed to a nanoemulsion including at least one oil, at least one oil based surfactant, at least one water base surfactant, water, and either an isolate or distillate including at least one of a CBD, THC, and a cannabinoid based oil.
Cahill et al. (US 2022/0331479 A1, priority 03/29/2022), directed to dermal patch formulations comprising 10% CBD, silicone adhesives, and penetration enhancers including oleic acid.
Cavin et al. (US 2016/0021907 A1, 01/28/2016), directed to printing processes onto materials with an edible ink comprising a vegetable extract colorant, having an advantage of able to print onto hydrophobic or hydrophilic surfaces.
Madehow.com (“How Temporary Tattoo Is Made - Material, Manufacture, Used, Processing, Components, Industry, Raw Materials.” 2/20/2006 as evidenced by Wayback Machine).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LUCY M TIEN whose telephone number is (571)272-8267. The examiner can normally be reached Monday - Friday 10:00 AM - 6:00 PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Frederick Krass can be reached at (571) 272-0580. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LUCY M TIEN/Examiner, Art Unit 1612
/FREDERICK F KRASS/Supervisory Patent Examiner, Art Unit 1612