DETAILED ACTION
A non-final Office action was mailed 16 January 2026 (“Office Action”).
Applicant’s reply was received 9 March 2026 (“Reply”).
Status of the Claims
The listing of claims filed with the Reply has been examined.
Claims 15–22, 27, and 28 are pending.
Claims 15, 23, and 27 are amended.
Claims 1–14, 24–26, and 29 are canceled.
Status of Rejections and Objections
The text of those sections of Title 35, U.S. Code not included in this action can be found in the Office Action.
Unless repeated herein, any objection or rejection in the Office Action is withdrawn.
Claim Interpretation
Amended claim 15 recites, “wherein the composition is configured for inhalation via smoking or vaping.”
The instant application does not define or explain what claim term means. In fact, the specification does not once recite “configured for.” Accordingly, the phrase is given its broadest reasonable interpretation. For the purposes of examination, Examiner interprets the term to mean the composition is capable of being inhaled by smoking or vaping.
Claim Rejections - 35 U.S.C. § 112
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.
Claims 23 and 27 are rejected under 35 U.S.C. § 112(d) 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.
Claims 23 and 27 depend from claim 15.
Claim 15 recites, “3 wt.% to 20 wt.% of exogenous terpenes.”
Claim 23 recites, “about 75 wt.% to about 90 wt.% of the active cannabinoid.”
Claim 27 recites, “about 3 wt.% to about 20 wt.% of exogenous terpenes.”
The term “about” allows the range in claim 23 to include more than 90 wt.% of the active cannabinoid. The term “about” allows the range in claim 27 to include less than 3 wt.% and more than 20 wt.% of exogenous terpenes.
To be proper dependent claims, claims 23 and 27 must narrow the scope of claim 15. Because the ranges in claims 23 and 27 are broader than those in claim 15, they do not narrow the scope of the claim upon which it depends. Thus, claim 27 is an improper dependent claim.
Applicant may cancel the claims, amend the claims to place the claims in proper dependent form, rewrite the claims in independent form, or present a sufficient showing that the dependent claims complies with the statutory requirements.
Examiner recommends deleting the term “about” in all claims.
Claim Rejections - 35 U.S.C. § 103
Claims 15–22, 27, and 28 are rejected under 35 U.S.C. § 103 as being unpatentable over US 2018/0125980 (“Finley”).
The Graham factors are addressed in turn below.
Determining the scope and contents of the prior art
Regarding claims 15–17, 19, 20, 23, 27, and 28, Finley discloses a composition comprising at least one cannabinoid, and formulated cannabinoid products also comprising a carrier or excipient that functions as an antioxidant. (Finley, ¶2; claim 1).
Finley discloses utilizing isolated cannabinoids in an excipient that is an oil-soluble compound having the ability to neutralize oxidative oxygen species, regulate the viscosity of the formulated product, and optimize stability and shelf-life of the product. (Id., ¶¶8–10). In some embodiments, the excipient is a-tocopherol (“tocopherol”). (Id., ¶¶11; 15; claim 1).
Finley explains the formulated products should include compositions that will not rapidly degrade and that have a viscosity suitable for delivery using a vaporizer, e-cigarette, or pen. (Id., ¶¶5–10; 172–180).
Finley discloses neutral cannabinoids (e.g., THC, CBD, CBG, CBN, etc.) can be present in an amount ranging from about 1% (w/w) to about 99% (w/w) and subranges thereof. (Id., ¶¶111–121). The subranges can be, for example, about 0.01% (w/w) to about 0.05% (w/w), or from about 0.05% (w/w) to about 0.1% (w/w), or from about 0.1% (w/w) to about 0.2% (w/w), or from about 0.2% (w/w) to about 0.3% (w/w), or from about 0.3% (w/w) to about 0.4% (w/w), or from about 0.4% (w/w) to about 0.5% (w/w), or from about 0.5% (w/w) to about 0.6% (w/w), or from about 0.6% (w/w) to about 0.7% (w/w), or from about 0.7% (w/w) to about 0.8% (w/w), or from about 0.8% (w/w) to about 0.9% (w/w), or from about 0.9% (w/w) to about 1% (w/w), or from about 1% (w/w) to about 5% (w/w), or from about 5% (w/w) to about 10% (w/w), or from about 10% (w/w) to about 15% (w/w), or from about 15% (w/w) to about 20% (w/w), or from about 20% (w/w) to about 25% (w/w), or from about 25% (w/w) to about 30% (w/w), or from about 30% (w/w) to about 35% (w/w), or from about 35% (w/w) to about 40% (w/w), or from about 40% (w/w) to about 45% (w/w), or from about 45% (w/w) to about 50% (w/w), or from about 50% (w/w) to about 55% (w/w), or from about 55% (w/w) to about 60% (w/w), or from about 60% (w/w) to about 65% (w/w), or from about 65% (w/w) to about 70% (w/w), or from about 70% (w/w) to about 75% (w/w), or from about 75% (w/w) to about 80% (w/w), or from about 80% (w/w) to about 85% (w/w), or from about 85% (w/w) to about 90% (w/w), or from about 90% (w/w) to about 95% (w/w), or from about 95% (w/w) to about 99% (w/w). (Id., ¶111). Other subranges include an amount ranging from about 0.01% (w/w) to about 1% (w/w), or from about 0.02% (w/w) to about 0.9% (w/w), or from about 0.03% (w/w) to about 0.8% (w/w), or from about 0.04% (w/w) to about 0.7% (w/w), or from about 0.05% (w/w) to about 0.6% (w/w), or from about 0.06% (w/w) to about 0.5% (w/w), or from about 0.07% (w/w) to about 0.4% (w/w), or from about 0.08% (w/w) to about 0.3% (w/w), or from about 0.09% (w/w) to about 0.2% (w/w). (Id., ¶112). Other subranges include an amount ranging from about 1% (w/w) to about 10% (w/w), or from about 2% (w/w) to about 9% (w/w), or from about 3% (w/w) to about 8% (w/w), or from about 4% (w/w) to about 7% (w/w), or from about 5% (w/w) to about 6% (w/w). (Id.). Other subranges include an amount ranging from about 5% (w/w) to about 99% (w/w), or from about 10% (w/w) to about 95% (w/w), or from about 15% (w/w) to about 90% (w/w), or from about 20% (w/w) to about 85% (w/w), or from about 25% (w/w) to about 80% (w/w), or from about 30% (w/w) to about 75% (w/w), or from about 35% (w/w) to about 70% (w/w), or from about 40% (w/w) to about 65% (w/w), or from about 45% (w/w) to about 60% (w/w), or from about 50% (w/w) to about 55% (w/w). (Id.). Other subranges are disclosed. (Id., ¶¶113–121).
Finley discloses acidic cannabinoids (e.g., THCA, CBDA, CBGA, etc.) can be present in an amount ranging from about 0.001% (w/w) to about 80% (w/w) and subranges thereof. (Id., ¶¶122–124). The subranges can be, for example, from about 0.01% (w/w) to about 0.05% (w/w), or from about 0.05% (w/w) to about 0.1% (w/w), or from about 0.1% (w/w) to about 0.2% (w/w), or from about 0.2% (w/w) to about 0.3% (w/w), or from about 0.3% (w/w) to about 0.4% (w/w), or from about 0.4% (w/w) to about 0.5% (w/w), or from about 0.5% (w/w) to about 0.6% (w/w), or from about 0.6% (w/w) to about 0.7% (w/w), or from about 0.7% (w/w) to about 0.8% (w/w), or from about 0.8% (w/w) to about 0.9% (w/w), or from about 0.9% (w/w) to about 1% (w/w), or from about 1% (w/w) to about 5% (w/w), or from about 5% (w/w) to about 10% (w/w), or from about 10% (w/w) to about 15% (w/w), or from about 15% (w/w) to about 20% (w/w), or from about 20% (w/w) to about 25% (w/w), or from about 25% (w/w) to about 30% (w/w), or from about 30% (w/w) to about 35% (w/w), or from about 35% (w/w) to about 40% (w/w), or from about 40% (w/w) to about 45% (w/w), or from about 45% (w/w) to about 50% (w/w), or from about 50% (why) to about 55% (w/w), or from about 55% (w/w) to about 60% (w/w), or from about 60% (w/w) to about 65% (w/w), or from about 65% (w/w) to about 70% (w/w), or from about 70% (w/w) to about 75% (w/w), or from about 75% (w/w) to about 80% (w/w). (Id., ¶122). Other subranges include an amount ranging from about 0.01% (w/w) to about 1% (w/w), or from about 0.02% (w/w) to about 0.9% (w/w), or from about 0.03% (w/w) to about 0.8% (w/w), or from about 0.04% (w/w) to about 0.7% (w/w), or from about 0.05% (w/w) to about 0.6% (w/w), or from about 0.06% (w/w) to about 0.5% (w/w), or from about 0.07% (w/w) to about 0.4% (w/w), or from about 0.08% (w/w) to about 0.3% (w/w), or from about 0.09% (w/w) to about 0.2% (w/w). (Id., ¶123). Other subranges include an amount ranging from about 1% (w/w) to about 10% (w/w), or from about 2% (w/w) to about 9% (why), or from about 3% (w/w) to about 8% (w/w), or from about 4% (w/w) to about 7% (w/w), or from about 5% (w/w) to about 6% (w/w). (Id.). Other subranges are disclosed. (Id., ¶124).
Finley discloses the cannabinoids can be combined with cannabinoid terpenes or non-cannabinoid terpenes, such as synthetic terpenes or terpenes derived from other plants. (Id., ¶¶16–19; 125–129). The terpenes can be present in an amount ranging from about 0.01 to about 15% (w/w). (Id., ¶¶128–129). For example, the total terpene content can range from about 0.1% (w/w) to about 0.2% (w/w), or from about 0.2% (w/w) to about 0.3% (w/w), or from about 0.3% (w/w) to about 0.4% (w/w), or from about 0.4% (w/w) to about 0.5% (w/w), or from about 0.5% (w/w) to about 0.6% (w/w), or from about 0.6% (w/w) to about 0.7% (w/w), or from about 0.7% (w/w) to about 0.8% (w/w), or from about 0.8% (w/w) to about 0.9% (w/w), or from about 0.9% (w/w) to about 1% (w/w). The total terpene content can range from about 1% (w/w) to about 2% (w/w), or from about 2% (w/w) to about 3% (w/w), or from about 3% (w/w) to about 4% (w/w), or from about 4% (w/w) to about 5% (w/w), or from about 5% (w/w) to about 6% (w/w), or from about 6% (w/w) to about 7% (w/w), or from about 7% (w/w) to about 8% (w/w), or from about 8% (w/w) to about 9% (w/w), or from about 9% (w/w) to about 10% (w/w), or from about 10% (w/w) to about 11% (w/w), or from about 11% (w/w) to about 12% (w/w), or from about 12% (w/w) to about 13% (w/w), or from about 13% (w/w) to about 14% (w/w), or from about 14% (w/w) to about 15% (w/w). (Id., ¶128).
Regarding claims 16 and 19, Finley discloses the cannabinoid can be D9-tetrahydrocannabinol. (Id., ¶¶108–109).
Regarding claims 17 and 20, Finley discloses the cannabinoic acid can be D9-tetrahydrocannabinolic acid. (Id., ¶110).
Regarding claim 18, Finley discloses the cannabis compositions and products can include isolated cannabinoids. The cannabinoids can be cannabis plant extracts, endocannabinoids, or synthetic cannabinoids; and the cannabinoids can be selected and combined in desired ratios. (Id., ¶¶8–19). The isolated cannabinoids have a purity of at least 90%. (Id., ¶16).
Regarding claim 21, Finley discloses a composition comprising a carrier in an amount ranging from about 1–95% (w/w). (Id., ¶¶15; 157–158). In some embodiments, the carrier is vegetable oil. (Id., ¶15). In some embodiments, the carrier includes a cannabis oil. (Id., ¶46).
Regarding claim 22, Finley discloses the addition of one or more fragrance modifiers in an amount ranging from 0.01–10% (w/w). (Id., ¶¶145–156).
Ascertaining the differences between the prior art and the claims at issue
Certain claims refer to a subrange of a range disclosed in Finley. For example, claim 1 recites “1 wt.% to 30 wt.% of cannabinoic acid” whereas Finley discloses a corresponding amount of about 0.001% (w/w) to about 80% (w/w) and subranges thereof.
Certain claims refer to an overlapping range of a range disclosed in Finley. For example, claim 1 recites “less than 2 wt.% of endogenous terpenes” and Finley discloses a corresponding amount ranging from about 0.01 to about 15% (w/w).
Resolving the level of ordinary skill in the pertinent art
The level of one of ordinary skill may be found by inquiring into: (i) the type of problems encountered in the art; (ii) prior art solutions to those problems; (iii) the rapidity with which innovations are made; (iv) the sophistication of the technology; and (v) the education level of active workers in the field. Custom Accessories, Inc. v. Jeffrey-Allan Industries, Inc., 807 F.2d 855, 962 (Fed. Cir. 1986). All of the factors may not be present in every case, and one or more of them may predominate. Envtl. Designs, Ltd. v. Union Oil Co., 713 F.2d 693, 696 (Fed. Cir. 1983). Based on the typically high education level of workers in the pharmaceutical art and the high degree of sophistication required to solve problems encountered in the art, Examiner finds a person having ordinary skill in the art would have at least a college degree in chemistry, biology, biochemistry, pharmacology, or a related field, and several years of experience.
Considering objective evidence present in the application indicating obviousness or nonobviousness
The instant application states the objective of the invention is to prevent oxidation of the active cannabinoids when exposed to air. (Spec., ¶¶2, 4, 39, 40, 49). Example 3 and FIGs. 1–8 show the addition of a cannabinoic acid to a purified active cannabinoid can prevent or minimize oxidation of the acidic cannabinoid. (Id., ¶¶80–88).
The question of obviousness
Based on the above factors, it would have been prima facie obvious for a person having ordinary skill in the art prior to the filing of the instant application to arrive at the claimed compositions based on Finley. Finley discloses compositions comprising cannabinoids, including neutral cannabinoids, such as THC, in an amount ranging from about 1–99% and acidic cannabinoids, such as THCA, in an amount ranging from about 0.001–80%. Finley discloses the cannabinoids can be selected and combined in a desired ratio, and the cannabinoids have a purity of at least 90%. Finley discloses the composition can further include a flavor and/or fragrance modifier in an amount ranging from 0.01–10%, non-cannabinoid terpenes, such as synthetic terpenes or terpenes derived from other plants, and/or a carrier in an amount ranging from about 1–95% (w/w). Finley discloses an inhalable composition for delivery using a vaporizer, pen, or e-cigarette. Accordingly, one of ordinary skill in the art would have had a reasonable expectation of success at arriving at the claimed compositions based on the disclosures in Finley.
The experimental examples and data provided in the specification has been considered but is not sufficient to overcome the prima facie case of obviousness because the examples do not demonstrate an unexpected result compared to the closest prior art. Example 4 (Beam Test) compares a sample containing THC with a sample containing THC and THCA. (Spec., ¶¶89–91). The specification states the sample containing THCA prevented oxidation and discoloration of the non-acidic cannabinoids compared to the sample containing THC only. Finley, however, discloses compositions containing THC and THCA.
Response to Arguments
Applicant’s arguments submitted with the Reply have been fully considered but are not persuasive to the extent they apply to the above rejection. Applicant argues that Finley does not disclose each element of the claimed invention. (Remarks, p.6). In particular, Applicant argues that Finley fails to teach or suggest a composition suitable for smoking or vaping because the compositions therein contain tocopherol, which may be considered toxic. (Id.). Applicant further argues that Finley does not disclose 3–20 wt.% of exogenous terpenes. (Id.).
The first argument fails because Finley expressly states the compositions are “conductive for loading or packing into modern day vaporizers, E-cigarettes, or pens.” (Finley, ¶175). Regardless of whether tocopherol is considered toxic, the claims do not exclude any toxic material. The claims only require the composition to be capable of inhalation, which Finley states is the case. The second argument fails because Finley expressly teaches the inclusion of exogenous terpenes (e.g., synthetic terpenes), and the terpenes may be included in an amount ranging from about 0.01 to about 15% (w/w). (Id., ¶¶18; 128–129; claim 14). Accordingly, Finley discloses all elements of the claimed invention.
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 C.F.R. § 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 C.F.R. § 1.17(a)) pursuant to 37 C.F.R. § 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.
Communication
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/J.M.N./Patent Examiner, Art Unit 1623
/ADAM C MILLIGAN/Supervisory Patent Examiner, Art Unit 1623
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