DETAILED ACTION
A non-final Office action was mailed July 29, 2025 (“Office Action”).
Applicant’s reply to the Office Action was received December 1, 2025 (“Reply”).
Status of the Claims
The listing of claims filed with the Reply has been examined.
Claims 1–6, 21, and 23–29 are pending.
Claims 7, 22, and 30–32 are canceled.
Claims 2–6 are withdrawn.
Status of Rejections and Objections
The text of those sections of Title 35, U.S. Code and/or text providing the basis for non-statutory double patenting rejections not included in this action are set forth in the Office Action.
Unless repeated herein, any objection or rejection in the Office Action is withdrawn.
Claim Rejections - 35 U.S.C. § 103
Claims 1, 21, and 23–29 are rejected under 35 U.S.C. § 103 as being unpatentable over Atsmon et al., J. Pharmaceutical Sciences (2018), 107, 1423–29 (“Atsmon”), Barnes, Michael P., Expert Opin. Pharmacother. (2006), 7(5), 607–615 (“Barnes”), Howard et al., J. Pain and Symptom Management (2013), 46(1), 142–149 (“Howard”), and Reinarman et al., J. Psychoactive Drugs (2011), 43(2), 128–135 (“Reinarman”).
The Graham factors are addressed in turn below.
Determining the scope and contents of the prior art
Atsmon states Δ9-tetrahydrocannabinol (THC) and cannabidiol (CBD) are the two most prominent cannabinoids in cannabis plants. (Atsmon, p.1424). Atsmon states “THC possesses psychoactive effects” and “CBD alleviates, at least partly, the untoward effects of THC.” (Id.).
Atsmon states that cannabinoids can be administered by smoking, inhalation, oral, sublingual, rectal, ophthalmic, and transdermal. (Id., p.1423).
Atsmon states the active ingredients of cannabis can be extracted or chemically synthesized, and have been incorporated in vapor, aerosols, cookies, topical creams, and suppositories. (Id., pp.1423–24). In order to have reproducible dose proportionality, pharmaceutical-grade delivery systems were developed. (Id., p.1424).
Atsmon states: “The THC/CBD oral formulation is easy to administer and enables flexibility in doses of cannabinoid that may be loaded with up to 100 mg per capsule of either THC, CBD, or their combination.” (Id.).
Atsmon discloses a formulation comprising THC and CBD in a ratio of about 1:1. (Id.). Atsmon states the components were purchased separately and mixed with other components to obtain an oily solution. (Id).
Howard explains the effects of THC include muscle relaxation, analgesia, and antiemesis, but also psychosis, anxiety, and sedation. (Howard, p.144).
Howard states the negative effects can be modified by other cannabinoids, such as CBD, which can reduce THC-induced anxiety. (Id.). Howard states mixtures of THC and CBD can be formulated “to improve the efficacy/tolerability profile” of THC. (Id.).
Barnes states: “Plant extracts have potential advantages over single synthetic cannabinoids, as other plant components are known to have therapeutic or synergistic activity.” (Barnes, p.609). Referring to a literature review of medical uses of cannabis and THC, Barnes states: “They concluded ‘that there is good evidence to show that secondary compounds in cannabis may enhance the beneficial effects of THC. Other cannabinoid and non-cannabinoid compounds in herbal cannabis or its extracts may reduce THC-induced anxiety, cholinergic deficits and immunosuppression. Cannabis terpenoids and flavonoids may also increase cerebral blood flow, enhance cortical activity, kill respiratory pathogens and provide anti-inflammatory activity.’” (Id.) (citations omitted).
Barnes states: “The principal pharmacological effects of THC include analgesia, muscle relaxation, antiemesis and appetite stimulation, and it has psychoactive effects. CBD has analgesic, anticonvulsant, muscle relaxant, anxiolytic, neuroprotective, antioxidant and antipsychotic activity.” (Id.) (citations omitted).
Barnes states: “The therapeutic dose of THC is highly variable between patients, and, therefore, it is important that the patient can accurately control their dose to get an adequate therapeutic response whilst avoiding intolerable side effects. The oromucosal route of administration allows self-titration by delivering small variable doses and is a convenient and accessible route of delivery that enables patients to take medication frequently throughout the day while maintaining a normal lifestyle.” (Id.).
Reinarman discloses insomnia is one of the most common reasons for medical marijuana to be prescribed to patients. (Reinarman Abstract).
The instant specification acknowledges that THC and CBD can be synthesized using methods disclosed in the prior art. (Spec., ¶¶33–34). The instant specification acknowledges that “THC has been shown to . . . cause sleepiness, drowsiness, and other side effects beneficial to improving sleep and decreasing symptoms related to insomnia.” (Spec., ¶5).
Ascertaining the differences between the prior art and the claims at issue
The cited references may not disclose the claimed concentration ranges and/or ratio of THC to CBD in the composition.
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 specification discloses the use of an “Insomnia Solution” and states the solution was efficacious for improving sleep in human subjects. (Spec., ¶¶64–77). Table 1 shows some subjects received a solution with a higher concentration of THC than CBD, while other subjects received a higher concentration of CBD than THC. Example 1 (Pam W.) received a solution with 250 mg/oz of CBD and 1000–2000 mg/oz of THC. (Id.). Example 6 (Kevin D.) received a solution with 250–500 mg/oz of CBD and 0–1000 mg/oz of THC. Example 9 (Jeff W.) received a solution with 500–1500 mg/oz of CBD and 0 mg/oz of THC. (Id.).
The question of obviousness
Based on the above factors, it would have been obvious for a person having ordinary skill in the art prior to the filing of the instant application to combine or modify the disclosures of Atsmon, Barnes, Howard, and Reinarman to arrive at the claimed compositions.
The cited references establish THC and CBD are the two most prominent cannabinoids in cannabis plants, and have been combined in a pharmaceutical composition because their respective effects are additive or synergistic. The cited references establish a therapeutic dose of THC is highly variable between patients; therefore, it is important that the patient can accurately control their dose to get an adequate therapeutic response whilst avoiding intolerable side effects.
To that end, the cited references establish that THC and CBD can be synthesized and combined in a liquid and in desired amounts. The cited references establish THC and/or CBD are useful for treating symptoms of insomnia, and the instant specification confirms the same. While THC is known to treat symptoms of insomnia, other cannabinoids like CBD are useful to modify potentially untoward effects of THC for the subject. Thus, it would have been obvious to optimize a composition comprising THC with a relative amount of CBD to obtain a treatment for the symptoms of insomnia without the untoward effects reported by some subjects.
Although the references do not disclose the specific concentration ranges for THC and CBD recited in the instant claims, optimizing the concentrations in view of existing compositions in the prior art would have been routine optimization and within the skill of one of ordinary skill in the art. MPEP § 2144.05(II)(A) (“Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical.”). The instant specification does not establish the criticality of the concentration ranges or ratios recited in the claims for THC and CBD. See MPEP 716.02(d).
One of ordinary skill in the art would have been motivated to modify or combine the cited references to improve the efficacy/tolerability profile of THC for treating insomnia. There would have been a reasonable expectation of success at arriving at the claimed invention because methods of isolating or synthesizing THC and CBD were known in the art, combining desired amounts of THC and CBD into a composition was known in the art, there is a high level of skill for those in the art, and the ordinary artisan would have been capable of readily making and using the claimed pharmaceutical compositions for the intended purpose of treating insomnia.
Response to Arguments
Applicant’s arguments submitted with the Reply, along with the Declaration of Shaun Land (“Land Declaration”), have been considered but are not persuasive.
Applicant argues the Office Action does not establish a prima facie case of obviousness because the references do not disclose the claimed concentrations of the THC and CBD components. (Remarks, pp.9–12). In response, Atsmon discloses a composition comprising up to 100 mg of THC and/or CBD: “The THC/CBD oral formulation is easy to administer and enables flexibility in doses of cannabinoid that may be loaded with up to 100 mg per capsule of either THC, CBD, or their combination.” (Atsmon, p.1424). Further, Barnes discloses Sativex, a composition comprising 27 mg/mL of THC and 25 mg/mL of CBD and notes: “The therapeutic dose of THC is highly variable between patients, and, therefore, it is important that the patient can accurately control their dose to get an adequate therapeutic response whilst avoiding intolerable side effects. The oromucosal route of administration allows self-titration by delivering small variable doses and is a convenient and accessible route of delivery that enables patients to take medication frequently throughout the day while maintaining a normal lifestyle.” (Barnes, p.609). Thus, Atsmon teaches a composition can be formulated to contain THC and CBD in any amounts and Barnes teaches a specific example of a composition that allows a user to self-titrate dosage via the delivery of small amounts of liquid. Accordingly, while Atsmon and Barnes do not disclose the specifically claimed concentrations of THC and CBD, Barnes discloses a composition comprising 27 mg/mL of THC and 25 mg/mL of CBD and teaches the dosage varies between subjects so the concentration should allow for self-titration, while Atsmon teaches that any amounts of THC and CBD can be combined into a composition.
Applicant argues the claimed concentration ranges are not result-effective variables that would have been routine optimization for one of ordinary skill in the art. (Id., pp.12–16). To that end, Applicant argues Atsmon and Howard do not disclose a method of treating insomnia and therefore do not provide a starting point for optimizing the concentrations. (Id., p.13). In response, it should be noted that the claims are not directed to a method of treating insomnia. The claims are directed to a composition, and the references teach a composition comprising a desired amount of THC and CBD can be formulated for oral delivery. Because the claims merely recite an intended use of “treating one or more symptoms of insomnia,” the references only need to disclose a composition that is capable of that use. The compositions in the cited references are capable of treating the symptoms. Indeed, the instant specification acknowledges that “THC has been shown to . . . cause sleepiness, drowsiness, and other side effects beneficial to improving sleep and decreasing symptoms related to insomnia.” (Spec., ¶5).
Applicant argues the cited references do not provide a reason to modify/combine the references to arrive at the claimed composition. (Id., pp. 16–21). In response, Howard states mixtures of THC and CBD can be formulated “to improve the efficacy/tolerability profile” of THC. (Howard, p.144). And Barnes states: “The therapeutic dose of THC is highly variable between patients, and, therefore, it is important that the patient can accurately control their dose to get an adequate therapeutic response whilst avoiding intolerable side effects. The oromucosal route of administration allows self-titration by delivering small variable doses and is a convenient and accessible route of delivery that enables patients to take medication frequently throughout the day while maintaining a normal lifestyle.” (Id.). In view of Howard and Barnes, one of ordinary skill in the art would have been motivated to prepare a composition of a THC-CBD mixture with a desired efficacy/tolerability profile that can be self-titrated by the subject.
Applicant argues the Land Declaration provides evidence of unexpected results that establish the criticality of the CBD and THC concentrations and ratios. (Id., pp.21–22). The Land Declaration reports the findings of a sleep study comprising 69 subjects who were diagnosed with insomnia or complained about having sleep difficulties using the criteria in DSM-5-TR. (Land Declaration, ¶4). “Participants were instructed to orally administer 0.25 mL of the composition each night at bedtime and upon awakening the next morning evaluate and rate their sleep using the sleep questionnaire provided by the research facility. Participants were allowed to titrate the dose up or down if needed.” (Id., ¶5). The criteria and results of the study are reported and summarized by the declarant. (Id., ¶¶6–19). The sleep study criteria include: (1) sleep onset time; (2) number of sleep interruptions; (3) sleep duration; and (4) quality of sleep.
Criteria (4) cannot be measured. The quality of sleep is subjective and personal.
Criteria (1), (2), and (3) could be measurable using video or wearable technology, but there is no indication that the subjects were monitored in any way during the sleep study. The Land Declaration states the subject personally rated their sleep in a questionnaire after awaking from sleep. Without assistance, it is unclear how a subject would have known their sleep onset time (i.e., a subject falling asleep doesn’t look at a clock). Providing an estimate of the sleep onset time in the morning is problematic because similar times like 14 minutes and 15 minutes fall into different ratings in the questionnaire. Similarly, it is unclear how the sleep interruptions are recalled by the patient without video or wearable technology, or which types of sleep interruption qualify for the questionnaire (presumably, going to the bathroom would count, but it is unclear if coughing or rolling over during sleep would count). Thus, the sleep study criteria are only qualitative in nature and relied on the perception or estimates of a subject for the data. Furthermore, some ratings used in the criteria overlap and fail to demarcate an actual difference in sleep. For example, if a subject has 4 sleep interruptions, the rating can be 2 or 3. (Land, ¶8). If a patient sleeps a total of 5 hours and 2 minutes, then the sleep duration would be rated 3; but if the patient happened to misreport the sleep onset time by 2 minutes, then the sleep duration should have been given a rating of 2. In other words, a reporting error by the subject when completing the questionnaire in one criterion can be compounded in other criteria.
In addition to the flaws in its design, the study was implemented in a curious manner. For example, only one subject received a composition having a CBD:THC ratio of 1:3, whereas 52 subjects received a composition having a CBD:THC ratio of 1:4. (Land, ¶11). So, the ratings by the 52 subjects were averaged out but the ratings by the one subject were not. And the subject who received a composition having a CBD:THC ratio of 1:3 reported an average rating of 2.8, which is the same average rating reported by the 7 subjects who received a composition having a CBD:THC ratio of 1:8. (Id.). Thus, it appears that compositions deemed inside and outside the claimed range or ratio are capable of the intended use recited in the claims. In sum, the results of the study are tainted by design and otherwise fail to articulate objective and meaningful results.
Finally, it is noted the data presented in Land Declaration are subject-oriented and focus on the administration of a composition to the subject and the subjective reporting by the subject on quality of the subject’s sleep. As noted, the claims are not directed to a method of administering the composition to a subject to treat insomnia. Rather, the claims are directed to a composition, and none of the data evidences a distinguishing property inherent to the claimed composition that is not also inherent to other compositions outside of the claim scope. For example, Applicant notes that Atsmon discloses an oral composition PTL401 that improves the bioavailability relative to SATIVEX. (Remarks, p.14). Bioavailability is a measurable property that is inherent to a composition, thus allowing an objective way to compare compositions. By contrast, the data provided in the Land Declaration and relied on by Applicant is relevant to a method of treating insomnia and fails to articulate an objective way to compare compositions comprising a mixture of THC and CBD.
Accordingly, for the above-reasons, the rejection is maintained.
Conclusion
THIS ACTION IS MADE FINAL. 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