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 .
Claim Status
Claims 1-18 are cancelled.
Claims 19-32 are new.
Priority
PNG
media_image1.png
282
1310
media_image1.png
Greyscale
The limitation of “β-nicotinamide adenine dinucleotide” was first introduced in application 17575035. The effective filing date is then 7/16/2021.
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on 8/21/25 and 1/8/25 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 19-32 are rejected under 35 U.S.C. 103 as being unpatentable over Yuan et al. (US20210299081).
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103, the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103.
Applicant claims, for example:
PNG
media_image2.png
168
920
media_image2.png
Greyscale
PNG
media_image3.png
158
932
media_image3.png
Greyscale
PNG
media_image4.png
116
906
media_image4.png
Greyscale
Level of Ordinary Skill in the Art
(MPEP 2141.03)
MPEP 2141.03 (I) states: “The “hypothetical ‘person having ordinary skill in the art’ to which the claimed subject matter pertains would, of necessity have the capability of understanding the scientific and engineering principles applicable to the pertinent art.” Ex parte Hiyamizu, 10 USPQ2d 1393, 1394 (Bd. Pat. App. & Inter. 1988). The level of skill is that of a THC formulation research scientist, who has conventional knowledge of chemistry, pharmacokinetics, and pharmaceutical dosage formulation components and methods to design safe, stable, and effective cannabis products to make consumer-ready goods like edible foods, beverages, topicals, and tinctures.
In addition, the prior art itself reflects an appropriate level (MPEP 2141.03(II)).
Determination of the scope and content of the prior art
(MPEP 2141.01)
Regarding claims 19 and 29, Yuan et al. teach powder solid powder compositions (Claim 1) comprising Δ9-tetrahydrocannabinol (Claim 9) and a flavoring (Claim 30) which can be saccharin (Table 3a [0218]). Yuan et al. teach adding an additional active ingredient which can be the nutraceutical NADH [0163], which is nicotinamide adenine dinucleotide in the reduced state and would be the β isomer because it is an active ingredient and not an inactive ingredient as would be the α isomer. It is the Examiner’s position that disclosure of NADH renders obvious NAD to the ordinary artisan in this art. The amount of cannabinoid powder can be from 10-80% and the amount of flavorant saccharin can be from 0.1-50% (Table 3a). Yuan et al. teach pharmaceutically- or nutraceutically-acceptable carriers (Table 3a; claims 14-16, 18).
Regarding claims 19-23 and 25-28, teach dissolving the active ingredients into a solution (Example 1, [0189]) and then removing the solvent by evaporation [0194, 0206] or by lyophilization [0198, 0210]. See also [0208-0211]. The synthetic or extracted source of the Δ9-tetrahydrocannabinol is obvious to the artisan obtaining Δ9-tetrahydrocannabinol. They are the same compound.
Regarding claims 29-31, Yuan et al. teach: “The term "therapeutically effective amount" means an amount of active ingredient(s) that will elicit a desired biological or pharmacological response, e.g., effective to prevent, alleviate, or ameliorate symptoms ( e.g., reducing or eliminating irritation and/or coughing and/or respiratory tract irritation), treat a disease or disorder (e.g., nausea); or cause a psychoactive effect in the individual. The compositions described herein can comprising an effective or therapeutically effective amount of a cannabinoid and/or a terpene.” [0052]. Yuan et al. also teach: “In one embodiment, the invention provides a method of reducing or preventing nausea or vomiting in a subject in need thereof, comprising administering to the subject an effective amount of a cannabinoid composition of the present invention.” [0183]. Accordingly, Yuan et al. teach a pharmaceutical/nutraceutical composition comprising a solid powder Δ9-tetrahydrocannabinol in a therapeutically effective amount for use in methods of treating a disease, disorder or condition with a therapeutic/therapeutically effective composition.
Regarding claim 32, Yuan et al. teach a beverage product [0031, 0093, 0115, 0217]. Yuan et al. also teach a gummy ([0116-0117, 0026]; Table 12), which would be a food product.
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02) and Finding of prima facie obviousness
Rational and Motivation (MPEP 2142-2143)
The difference between the instant application and Yuan et al. is that Yuan et al. do not expressly teach dissolving the Δ 9-THC in a solvent system to form a Δ 9-THC solution, dissolving the powder former in a solvent system to form a powder former solution, combining the Δ 9-THC solution and the powder former solution to form a combined solution containing both Δ 9-THC and the powder former compound wherein the molar ratio of Δ 9-THC to powder former ranges from about 4:1 to about 1:4, ranges from about 3:1 to about 1:3, ranges from about 2:1 to about 1:2 or is about 1:1 of the solid powder composition. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to perform the method of Yuan et al. by dissolving the Δ 9-THC in a solvent system to form a Δ 9-THC solution, dissolving the powder former in a solvent system to form a powder former solution, combining the Δ 9-THC solution and the powder former solution to form a combined solution containing both Δ 9-THC and the powder former compound wherein the molar ratio of Δ 9-THC to powder former ranges from about 4:1 to about 1:4, ranges from about 3:1 to about 1:3, ranges from about 2:1 to about 1:2 or is about 1:1 of the solid powder composition, and produce the instant invention. One of ordinary skill in the art would have been motivated to do this because for the following sound articulated reasoning with rational underpinning based upon the evidence. First of all, the molar ratio of Δ 9-THC to powder former is easily optimized to produce the desired powder comprising the flavoring agent saccharin and β-nicotinamide adenine dinucleotide taught by Yuan et al. See MPEP 2144.05 (II) (A): “[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.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Especially when Yuan et al. already teach that the amount of cannabinoid powder can be from 10-80% and the amount of flavorant saccharin can be from 0.1-50% (Table 3a). Thus, providing general conditions for optimization by the ordinary artisan to produce a powder Δ 9-THC product. Secondly, Yuan et al. teach dissolving all the active ingredients to make a solution which is later dried by evaporation or lyophilization but does not appear to teach making separate solutions that are then combined prior to drying. However, the end result is the same and the order of mixing components by application does not appear to be inventive without more. See MPEP 2144.04 IV: “See also In re Burhans, 154 F.2d 690, 69 USPQ 330 (CCPA 1946) (selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results); In re Gibson, 39 F.2d 975, 5 USPQ 230 (CCPA 1930) (Selection of any order of mixing ingredients is prima facie obvious.).”
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
From the combined teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the combined references, especially in the absence of evidence to the contrary.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERNST V ARNOLD whose telephone number is (571)272-8509. The examiner can normally be reached M-F 7-3:30.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian Y Kwon can be reached at 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ERNST V ARNOLD/Primary Examiner, Art Unit 1613
Prosecution Insights