This action replaces the Office communication mailed 12/29/2025, and
resets the time for Applicant response.
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 .
Election/Restriction
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-17, drawn to a cannabinoid composition comprising: a liquid carrier; a first lipid carrier comprising at least one cannabinoid, the first lipid carrier having a particle size from 10 nm to 100 nm; and a second lipid carrier comprising at least one cannabinoid, the second lipid carrier having a particle size from 200 nm to 600 nm, classified in A61K 31/658.
II. Claims 18-20, drawn to a method of manufacturing a beverage comprising a cannabinoid composition, the method comprising: replacing at least a portion of the oxygen in a container with carbon dioxide; receiving a cannabinoid composition in the container, the cannabinoid composition comprising a liquid carrier, a first lipid carrier comprising at least one cannabinoid, the first lipid carrier having a particle size from 10 nm to 100 nm, and a second lipid carrier comprising at least one cannabinoid, the second lipid carrier having a particle size from 200 nm to 600 nm; receiving a sterilant and water in the container; and capping the container, classified in A61K 9/0095.
The inventions are independent or distinct, each from the other because:
Inventions I and II are related as product and process of use. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In the instant case the product of claim 1 can be formulated in a non-beverage form, such as a gel capsule.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
(a) separate classification which shows that each invention has attained recognition in the art as a separate subject for inventive effort, and also a separate field of search;
(b) separate status in the art even though the inventions are classified together, each invention forming a separate subject for inventive effort as recognized by inventors;
(c) search for one of the inventions is not likely to result in finding art pertinent to the other invention(s) (e.g., searching different classes/subclasses or electronic resources, or employing different search queries), a different field of search is shown, even though the two are classified together; and
(d) the inventions are likely to raise serious examination issues including non-prior art issues under 35 U.S.C. 101, pre-AIA 35 U.S.C. 112, first paragraph and/or 35 U.S.C. 112(a) that are relevant to one invention and not relevant to the other invention.
Applicant is advised that the reply to this requirement to be complete must include (i) n election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
During a telephone conversation with Justine Gozzi on January 5, 2026 a provisional election was made with traverse to prosecute the invention of Group I, claims 1-17. Affirmation of this election must be made by applicant in replying to this Office action. Claims 18-20 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Claim Objections
Claim 6 is objected to because of the following informalities: “claim1”. Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-3, 7, 9, and 14-17 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being clearly anticipated by Alsayar (WO 2020/037408A1; see 03/14/2024 IDS).
Alsayar teaches a “cannabis-infused product comprising a cannabinoid profile including one or more cannabinoid, a first composition for controlling onset of the cannabinoid profile and a second composition for controlling offset of the cannabinoid profile in a subject” (abstract; see entire document including title; paras.0030-32; Examples 1-19; claim 1). Claim 5 recites the cannabis-infused product wherein “the first composition comprising particles having a first particle size distribution (PSD1) and the second composition comprising particles having a second particle size distribution (PSD2), wherein PSD1 <PSD2”. PSD1 is between 10 and 100 nm (claims 7, 8; Examples 2, 15; see paras.0064-68; paras.0630-32, Examples 16 and 17) and PSD2 is greater than 200 nm, 300 nm, 400 nm, or 500 nm (para.0067; Examples 3-12).
The cannabis-infused product comprises a liquid carrier such as water, and lipid carrier particles comprise the cannabinoid and a lipid such as a carrier oil (paras.0099-0103, 0397). Surfactant is used to emulsify the cannabinoid into particles, whose particle size depends on the emulsifier combinations and excipient ratios (para.0077, 0087, 0398, 0595-97). A pH stabilizer, i.e., a buffer, may be used (para.0097). The first and the second compositions may, i.e., need not, comprise different “cannabinoid profile” (para.0060). The cannabis-infused product may be a liquid or a solid dosage form (paras.0009-10) and administered orally or topically (paras.0349, 0355).
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.
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.
Claim(s) 1-9 and 12-17 are rejected under 35 U.S.C. 103 as being unpatentable over Alsayar (WO 2020/037408A1; see 03/14/2024 IDS).
Alsayar does not expressly and specifically teach the limitations in claims 4-6, 8, 12, and 13. However it would have been prima facie obvious for one having ordinary skill in the art before the effective filing date to devise Alsayar’s cannabis-infused product comprising the concentrations of the first composition and the second composition as recited in instant claims 5 and 6, and ratios of the first composition and the second composition within the range in claims 12 and 13. The skilled person would have been suggested to do so because Alsayar teaches mixing a first composition comprising THC with particle size under 100 nm and a second composition comprising CBD with particle size over 200 nm, for example 10 mg THC and 100 mg CBD in 355 ml of beverage (paras.0630-32, Examples 16, 17), made using the first compositions of Example 15 comprising 1.74-2.67% THC distillate and the second compositions comprising, e.g., 5% CBD (Example 4, para.0602-03; see Examples 5-12). Alsayar further teaches the w/w ratio of THC to CBD ranging from 1:1000 to 1000:1 (para.0042). Therefore the skilled person could tailor the concentrations of the first and the second compositions, comprising THC and CBD, respectively, within Alsayar’s guidelines, according to the desired potency. For result-effective variables, in the case where claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. MPEP § 2144.05 (citations omitted). Furthermore, optimization within prior art conditions or through routine experimentation does not support patentability absent comparative evidence of criticality of the claimed range. See MPEP § 2144.05 (II) (citations omitted).
Regarding claims 4 and 8, Alsayar discloses diverse concentration ranges of water as the liquid carrier for both the first and the second compositions, e.g., 83.72%, 90.39% (paras.0596-619, Tables 1-6). Similarly the concentration of surfactant such as Tween80 and Span80 in the first and the second compositions include 2%, 5%, and 8% (para.0596 Table 2, para.0602 Example 4, para.0629 Table 4) which are all within the range in claim 8. Therefore combination of the first and the second compositions would result in liquid carrier, surfactant concentrations within the ranges in claims 4 and 8.
Claim(s) 1-17 are rejected under 35 U.S.C. 103 as being unpatentable over Alsayar (WO 2020/037408A1; see 03/14/2024 IDS) in view of Gerardi (WO 2021/116825A1; see 03/14/2024 IDS).
Alsayar does not specifically teach the concentration of the buffer or the pH as in claims 10 and 11.
Gerardi is drawn to products comprising a cannabinoid, a filler, and at least about 10% by weight water (title; abstract). Gerardi teaches including a buffering agent, typically at less than about 5% based on the weight of the oral product (p.23 lines 4-12). Furthermore the oral product “may have any suitable pH”, including about 4 (p.23 lines 17-18, 28-30). “About 4” is close to the 3.7 in claim 11. A prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties, i.e., modifying the release rate or protecting from premature reactions. MPEP § 2144.05(I) (citations omitted).
It would have been prima facie obvious for one having ordinary skill in the art before the effective filing date to combine the teachings of Alsayar and Gerardi as recited in the instant claim(s). The skilled person would have been motivated to do so because both are drawn to compositions comprising cannabinoids, water, and buffering agents, and Gerardi teaches suitable concentration range of the buffering agent and the pH for such compositions.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to H. S. PARK whose telephone number is (571)270-5258. The examiner can normally be reached on weekdays.
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, Ali Soroush can be reached at (571)272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/H. SARAH PARK/Primary Examiner, Art Unit 1614