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 .
Status of the Claims
Acknowledgement is made of the response filed on April 27, 2026. In that response, claims 1, 4-10, and 16 were amended. Claims 1-17 are treated on the merits in this action. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-17 in the reply filed on April 27, 2026 is acknowledged.
Claims 18-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on April 27, 2026.
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 1 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation "the cannabinoid product" in the last line. There is insufficient antecedent basis for this limitation in the claim. This phrase might be referring to the “cannabinoid composition”; however that composition could be used as a component in final products, such as the dosage forms in claim 16.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 11 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 11 recites “wherein the pH of the composition ranges from 3 to 3.7” which includes 3.7. Claim 11 depends from claim 1 which recites “a pH of less than 3.7” which excludes 3.7 and is therefore does not incorporate all the limitations of claim 1 . Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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) 1-17 are rejected under 35 U.S.C. 103 as being unpatentable over Alsayar (WO 2020/037408A1) in view of Jackowetz (US 2020/0170944).
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). A 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).
Alsayar does not specifically teach an example composition having a pH of less than 3.7 as in claim 1.
Jackowetz teaches water- soluble formulations of cannabinoids for use in beverages, i.e., oral dosage forms (title; abstract; see paras.0015-29, 0069-90, 0131, 0135-44, 0162-0207, 0290-370; claims 1-18). The “water-soluble formulations comprise a cannabinoid or a cannabis-derived compound, an emulsifier, and a glycerin-based carrier surfactant” and “the water-soluble formulations may be a liquid …” (para.0011). In other words they comprise a liquid, lipid carriers, and surfactant to form emulsion particles of the cannabinoid. (paras.0147, 0388). Jackowetz expressly teaches “the pH of the water-soluble formulation and/or the products containing the water-soluble formulation is adjusted to between 2.5 and 4.5” (para.0207), e.g., 3.49 (Table 1 p.31), and teaches using pH adjusting gents (para.0287, 0407, 0430). In Example 7, solutions (3) and (4) comprise 0.4% of sodium and potassium citrate which Applicant refers to as “buffer” (para.[0025]) Specification as filed).
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 Jackowetz and prepare Alsayar’s product to have a pH within the ranges as recited in the instant claim(s). The skilled person would have been motivated to do so because both are drawn to compositions comprising emulsion particles comprising a cannabinoid for use in beverages and such, Alsayar does not limit its compositions to specific pH range, and Jackowetz teaches expressly teaches “the pH of the water-soluble formulation and/or the products containing the water-soluble formulation is adjusted to between 2.5 and 4.5” (para.0207), e.g., 3.49 (Table 1 p.31), to obtain products which are “physically and chemically stable , transparent or translucent in colour, calorie-free, and have minimal flavor” (abstract).
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.
Response to Arguments
Although new rejections are made above Applicant’s arguments are addressed now to the extent they have not been rendered moot and are relevant to the above rejections.
Applicant's arguments filed April 27, 2026 have been fully considered but they are not persuasive. Applicant argues that Alsayar does not teach the range of 200 nm to 600 nm. (Remarks, 7, April 27, 2026.)
In response it is noted that Alsayar teaches various values within the range, e.g., 200 nm, 250 nm, and so on. Prior art need not teach the entire range, i.e., the minimum and the maximum values of a range as recited in a claim, to be apposite.
Applicant further argues regarding Gerardi that a pH of about 4 is not close to a pH of 3.7 by calculating the hydrogen ion concentration that the pH values represent. (Remarks, 8-9, April 27, 2026.)
This argument has been considered but is moot because the new ground of rejection does not rely on Gerardi.
CONCLUSION
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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
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