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 . 1
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 Aug 14 2025 has been entered.
Status of Claims
Claims 28-35 and 38-48 are pending. Claims 29-32 and 38-43 are withdrawn. Claims 28, 33-35 and 44-48 are under examination as they are directed to elected Group I and species #LF3.
• 19.5 % cannabinoid (CBD);
• 0.05% vitamin E;
• 0.3% flavoring agent;
• 70.15 of sesame oil; and
• 10% ethanol.
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on May 2 2025 and Aug 14 2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Interpretation
Claim 28 is directed towards an oral composition comprising:
about 10 to about 17% w/w cannabidiol (CBD);
60 to 85% w/w sesame oil;
optionally 5 to 15% w/w ethanol;
optionally a sweetener; and
optionally a flavoring agent,
optionally vitamin E; and
optionally a preservative,
wherein the CBD has a purity of greater than 98% w/w, and wherein the
composition is a liquid composition for oral administration and wherein the CBD is prepared by combining p-menthadienol and olivetol in a solvent selected from the group consisting of toluene, dichloromethane, and hexane, and in the presence of a p-toluene sulfonic acid catalyst.
On its face, the composition of claim 28 purports to be limited to cannabidiol (CBD) and sesame oil by virtue of the transitional phrase “consisting essentially of.” MPEP 2111.03 III., notes “consisting essentially of” limits the scope of the claim to specified materials or steps “and those that do not materially affect the basic and novel characteristic(s)” of the claimed invention.
Per the analysis of In re Herz, cited in MPEP 2111.03(III), the invention’s specification is analyzed to determine whether the presence of ingredients beyond CBD and sesame oil, would materially affect the basic and novel characteristic of the claimed invention. Table 24 of the specification (at paragraph 180), lists a cannabinoid (class of compounds that include CBD), and sesame oil, formulation LF1; and formulations LF2 and LF3 with cannabinoid, sesame oil, with Vitamin E and flavor. Formulations LF4, LF5, LF6, LF7 are similar but replace sesame oil with sunflower oil, corn oil, soybean oil and a decanoyl octanoyl glyceride mixtures (fatty acid esters). Example 6 is directed solely to the Stability of formulation LF1 which is only sesame oil and CBD (see Table 25 for data regarding a three month stability data).
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Thus prior art noting sesame oil and CBD compositions will be relevant to the prior art analysis of patentability. Note while Applicant states consisting essentially of is intended to exclude excipients that affect solubility, outside of CBD and sesame oil, the claiming of ethanol an optional excipient, which as a known solvent/surfactant, undercuts Applicant’s definition of “consisting essentially of,” as it allows for an optional solvent/surfactant (ethanol) to be included into the claimed formulation purported to be consisting essentially of CBD and sesame oil. Because there is question as to what the basic and novel characteristics required by the claimed invention, “consisting essentially of” will be construed as equivalent to “comprising.””
With regard to the limitation of “and wherein the CBD is prepared by combining p-menthadienol and olivetol in a solvent selected from the group consisting of toluene, dichloromethane, and hexane, and in the presence of a p-toluene sulfonic acid catalyst,” this limitation is in essence a functionally descriptive, product by process claim limitation of the CBD per se claimed. However, this process limitation to prepare the CBD does not provide patentable weight to the claim, as per MPEP 2113 (I), Product by Process Claims.2 Therefore, a teaching or suggestion of CBD prior to the time of the claimed invention will be relevant in the prior art analysis.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), 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. Applicants are 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(a).
Claims 28, 34-35 and 44-48, are rejected under 35 U.S.C. 103 as being unpatentable over Farrimond et al. Cannabinol and cannabidiol exert opposing effects on rat feeding patterns Psychopharmacology (2012) 223:117–129 in view of Murty (U.S. 2011/0092583) A1 and Goskonda (U.S. (2011/0306660). For clarity of record, Farrimond is cited on the PTO-892 form. Murty was previously cited by the Examiner. Goskonda was cited as US ref. No. 1 on the IDS dated July 8 2021.
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Regarding claim 28 and the core elements of a cannabinoid compound in a sesame oil based carrier, Farrimond teaches CBD solutions prepared by dissolving CBD in sesame oil. See page 120, first paragraph. See also Table 1, page 119 noting doses of cannabidiol doses. Farrimond teaches these CBD sesame oil solutions were orally dosed (p.o.) to adult male rat subjects. See abstract.
While teaching a composition consisting essentially of CBD and sesame oil, Farrimond does not teach the claimed percentages of CBD and sesame oil, or the various “optional” excipients.
Murty discloses an oral dosage form of cannabinoids comprising 1-90% wt % of cannabinoid (pharmacologically active) and 15-85% triglyceride carrier, ranges that overlap those claimed to render them obvious, per MPEP 2144.05. See claim 1. Murty further discloses oil based carriers, see the various vegetable oils of claim 8, including species of sesame oil, see paragraph 120 and Table 1. Note MPEP 2144.06, to establish obviousness for the various triglyceride carriers of Murty recited in claim 8.
Similar to Farrimond, Murty US Pub 538 teaches cannabidiol as a preferred embodiment. See claim 6 and paragraphs 49 and 113. See also working example 6, noting CBD, paragraph 248.
Regarding claim 28 and limitation of optional 5 to 15% w/w ethanol as an optional excipient, Murty’s Tables 5 and 6 disclose formulations of oil based cannabinoid based formulations allowing for ethanol to be used in amounts as claimed, 9.375% and 7.03 %. See Table 15.
Murty teaches the optional flavoring agents, such as various food based flavored oils such as apricot oil, cinnamon oil, clove oil, coconut oil, lemon oil, nutmeg oil, olive oil, orange oil, peppermint oil, as preferred embodiments. (Para. 82).
Regarding claim 28 and limitation of an optional sweetener, while such sweeteners are not disclosed expressly, Murty discloses an orally dosed form a cannabinoid as claimed, known to be flavored by various sweet fruit oils disclosed in paragraph 82. A person having ordinary skill in the art (PHOSITA) would have a reasonable expectation of success in arriving at the optional limitation of a sweetener from those sweet fruit oils.
Murty teaches the optional Vitamin E (α or γ tocopherol), vitamin E PEG 1000 succinate (d-α-tocopheryl polyethylene glycol 1000 succinate or TPGS), and mixtures thereof. See paragraphs 87, 128 and 229, Tables 3 and 10-15. Note that Vitamin E is a known antioxidant, where Murty teaches antioxidants, including (α tocopherol, aka Vitamin E). See claim 12. Further, see Murty claims 13-14 that teach overlapping amounts of antioxidants about 0.01-12.5 or about 0.01-15 wt%.
As an optional preservative of claim 28, Murty teaches antioxidants, (i.e. preservatives) in multiple instances, see abstract; where such antioxidants include ascorbyl palmitate, butylated hydroxy anisole, butylated hydroxy toluene, propyl gallate, α-tocopherol, and finally γ-tocopherol, etc. See paragraph 94. See also paragraph 97 noting combinations of two preservative/antioxidants, whereby ascorbyl palmitate and tocopherol provide optimal synergistic effects.
While Farrimond and US Pub 583 Murty teach an oral liquid composition of CBD, sesame oil and the optional ingredients claimed, it does not specifically recite the claimed CBD purity of greater than 98%.
However a PHOSITA would rely or use such a pure level of CBD as claimed because such purity levels are known and used in the art.
Regarding claim 28 and purity of greater than 98% w/w, Goskonda US 660 teaches its cannabinoids can be purified by methods as per US Publication 2005/0266108 (incorporated by reference in its entirety), where cannabidiolic acid purity is envisaged at most preferably greater than 94% (when tested by area of normalization of an HPLC profile), see claim 95. Therefore, a PHOSITA can envisage the claimed purity level of claim 28.
Similar to Murty, Goskonda US Pub 660 teaches various sweeteners suitable for incorporation in stable oral cannabinoid formulations, such as sucrose, fructose, sucralose, sorbitol, xylitol, saccharin, or combinations thereof, as sweetening agents. See paragraph 76.
A PHOSITA following the teachings of Farrimond and Murty (teaching the CBD, sesame oil, ethanol, sweetener and flavoring agent with optional ingredients), would have found it prima facie obvious to use high purity CBD as taught by Goskonda, thereby arriving at the instant claimed subject matter, with a reasonable expectation of success.
The rationale to support the finding of obviousness is combining prior art elements (Farrimond teaches a composition that only contains sesame oil and CBD) according to known methods (the concentration percentages of Murty, and Murty and Goskonda with regard to the optional excipients in amounts claimed) to yield predictable results.
Claim 34 recites the limitation of comprising about 0.01 to about 1 % w/w of flavoring agent. Claim 35 is directed to the composition of claim 28, comprising about 0.30 % w/w of flavoring agent. 28, 34-35 and 44-48
Regarding claims 34-35, Goskonda teaches flavoring agents from 0-5% w/w and preferably 0-1%, see paragraph 152 for its cannabinoid formulations.
Regarding claims 44-45, where CBD is about 20% w/w, sesame oil is about 70% w/w, Murty discloses an oral dosage form of cannabinoids comprising 1-90% wt % of cannabinoid (pharmacologically active) and 15-85% triglyceride carrier, ranges that overlap those claimed to render them obvious, per MPEP 2144.05. See claim 1.
Regarding the ethanol limitation of claims 46-47 at about 10% w/w, Murty’s Tables 5 and 6 disclose formulations of oil based cannabinoid based formulations allowing for ethanol to be used in amounts as claimed, 9.375% and 7.03 %. See Table 15. The term “about” allows for a teaching of 9.375%, teach the about 10% ethanol as claimed.
Claim 48 is directed to the liquid composition of claim 28, wherein
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Regarding claim 48, Farrimond teaches CBD solutions prepared by dissolving CBD in sesame oil. See page 120, first paragraph. See also Table 1, page 119 noting doses of cannabidiol doses. Farrimond teaches these CBD solutions were orally dosed (p.o.) to adult male rat subjects. See abstract.
Murty further discloses oil based carriers, see the various vegetable oils of claim 8, including species of sesame oil, see paragraph 120 and Table 1. Note MPEP 2144.06, to establish obviousness for the various triglyceride carriers of Murty recited in claim 8. With regard to the percentage of sesame oil, Murty discloses an oral dosage form of cannabinoids comprising 1-90% wt % of cannabinoid (pharmacologically active) and 15-85% triglyceride carrier, ranges that overlap those claimed to render them obvious, per MPEP 2144.05. See claim 1.
Similar to Farrimond, Murty US Pub 538 teaches cannabidiol as a preferred embodiment. See claim 6 and paragraphs 49 and 113. See also working example 6, noting CBD, paragraph 248.
Murty’s Tables 5 and 6 disclose formulations of oil based cannabinoid based formulations allowing for ethanol to be used in amounts as claimed, 9.375% and 7.03 %. See Table 15. The term “about” allows for a teaching of 9.375%, teach the about 10% ethanol as claimed.
Murty teaches Vitamin E (α or γ tocopherol), vitamin E PEG 1000 succinate (d-α-tocopheryl polyethylene glycol 1000 succinate or TPGS), and mixtures thereof. See paragraphs 87, 128 and 229. Note that Vitamin E is a known antioxidant, where Murty teaches antioxidants, including (α tocopherol, aka Vitamin E). See claim 12. Further, see Murty claims 13-14 that teach overlapping amounts of antioxidants about 0.01-12.5 or about 0.01-15 wt%.
Murty teaches, flavoring agents, such as various food based flavored oils such as apricot oil, cinnamon oil, clove oil, coconut oil, lemon oil, nutmeg oil, olive oil, orange oil, peppermint oil, as preferred embodiments. (Para. 82). Goskonda teaches flavoring agents from 0-5% w/w and preferably 0-1%, see paragraph 152 for its cannabinoid formulations.
Claim 28, 33-35 and 44-48 are rejected under 35 U.S.C. 103 as being unpatentable over Murty (U.S. 2011/0306660) in view of Goskonda (U.S. 2011/0306660), further view of ElSohly (U.S. 2006/0257463) as specifically applied to claims 33 and 36. ElSohly is cited on the PTO-892 form dated Oct 7 2024.
As discussed above, Murty and Goskonda teach the claimed CBD composition of claims 28, 34-35 and 44-48. However, it is noted they do no teach the species of claim 33 reciting the species of strawberry flavoring as recited therein.
However, a PHOSITA would have a reasonable expectation of success in arriving at the claimed invention because in the field of orally dosed cannabinoid formulations, benzyl alcohol and strawberry flavoring are known and readily available to one of ordinary skill in the art to formulate such compositions.
Regarding claim 33 claiming strawberry flavoring, US Pub 463 El Sohly discloses benzyl alcohol as a preservative, see paragraph 34 and strawberry as a flavoring agent, see paragraph 35.
A PHOSITA following the teachings of Farrimond and Murty (teaching the CBD, sesame oil, ethanol, sweetener and flavoring agent with optional ingredients) and Goskonda (teaching CBD purity and detailing sweeteners) would have found it prima facie obvious to use strawberry flavoring and benzyl alcohol as a preservative as taught by El Sohly.
RESPONSE TO ATTORNEY ARGUMENTS:
The Attorney response states that the transitional phrase “"consisting essentially of," excludes unrecited formulation components which materially affect emulsification of the liquid composition, such as unrecited co-solvents and surfactants. The Attorney response states Murty teaches compositions which are said to promote self-emulsification and there is no reason to why a PHOSITA would modify Murty to exclude a surfactant.
In response, as discussed above, the claiming of ethanol as an optional excipient, which as a known solvent/surfactant, undercuts Applicant’s definition of “consisting essentially of,” as it allows for an optional solvent/surfactant (ethanol) to be included into the claimed formulation purported to be consisting essentially of CBD and sesame oil. As noted above, it is pointed out that Farrimond provides a teaching to formulate a composition comprising solely CBD and sesame oil triglyceride lipid carrier, where Murty provides guidance to adjust concentration ranges of CBD and the sesame oil lipid carrier.
The Attorney response argues claim 28 has been amended to recite a synthetic process not taught or suggested by Murty.
In response, this limitation is in essence functionally descriptive, product by process claim limitation of the CBD per se of the composition. However, this process limitation to derive the CBD does not provide patentable weight to the claim, as per MPEP 2113 (I), Product by Process Claims.3 Therefore, a teaching or suggestion of CBD prior to earliest claimed priority of the claimed invention will be relevant in the prior art analysis.
The Attorney response argues amended claim 28 and balance of examined claims are not obvious over Murty in view of Goskonda, further in view of El Sohly, for the reasons discussed above with regard to Murty. In response, as discussed above, the claims are obvious over Farrimond, in view of Goskonda, further in view of El Sohly.
Conclusion and Correspondence
In conclusion no claims are allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM LEE whose telephone number is (571)270-3876. The examiner can be reached M-F.
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, Adam C. Milligan can be reached at (571) 270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/WILLIAM Y LEE/Examiner, Art Unit 1623
/ADAM C MILLIGAN/Supervisory Patent Examiner, Art Unit 1623
1 This application is a DIV of 14/724,351 filed on 05/28/2015, issued as US PAT 11224660. 14/724,351 has PRO 62/154,660 filed on 04/29/2015. 14/724,351 has PRO 62/004,495 filed on 05/29/2014.
2 “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted)
3 “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted)