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
This Office Action is in response to Applicant's Restriction Requirement remarks filed on November 24, 2025. Claim(s) 1-3, 5, 7-8, 13, 17, and 46-56 are pending. Claim(s) 48, 49, 51, 52, and 55-56 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant's election of Group I drawn to a method for treating or attenuating a mood disorder and election of species of CBD (first cannabinoid), kaempferol (additional therapeutic), and major depressive disorder (mood disorder) of the restriction requirement in the reply is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.03(a)). The requirement is deemed proper and is therefore made FINAL. Claim(s) 1-3, 5, 7-8, 13, 17, 46, 47, 50, 53, and 54 are examined herein insofar as they read on the elected invention and species.
Claim Rejections - 35 USC § 103
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 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.
Claims 1-3, 5, 7-8, 13, 17, 46, 47, 50, 53, and 54 are rejected under 35 U.S.C. 103 as being unpatentable over Leone-Bay (WO 2018/175992) of record in view of Yirmiya (Trends in Neuroscience, 2015) of record.
Leone-Bay teaches a fast-acting oral formulation comprising: (i) a cannabinoid comprising THC and/or CBD, (ii) an entourage-restoring molecule (claim 1). The entourage-restoring molecule is an additional cannabinoid, a terpene, a flavonoid, and an aroma- and flavor-conferring volatile (claim 4), wherein the additional cannabinoid is selected from: Δ8- tetrahydrocannabinol (Δδ-THC), Δ1 1-tetrahydrocannabinol (A1 1-THC), cannabigerol (CBG), cannabichromene (CBC), cannabinol (CBN), cannabinodiol (CBDL), cannabicyclol (CBL), cannabivarin (CBV), tetrahydrocannabivarin (THCV), cannabidivarin (CBDV), cannabichromevarin (CBCV), cannabigerovarin (CBGV), cannabigerol monomethyl ether (CBGM), cannabinerolic acid, cannabidiolic acid (CBDA), Cannabinol propyl variant (CBNV), cannabitriol (CBO), tetrahydrocannabinolic acid (THCA), and tetrahydrocannabivarinic acid (THCVA) (claim 5). The terpene is selected from: β-myrcene, a- pinene, β-pinene, linalool, d-limonene, β-caryophyllene, caryophyllene oxide, nerolidol, phytol, ocimene, terpinolene, terpinene, humulene, carene, bisabolol, valencene, elemene, farnesene, menthol, geraniol, guaiol, camphene, camphor, eucalyptol, pulegone, sabinene and phellandrene (claim 6); the flavonoid is selected from: cannaflavin A, cannaflavin B, cannaflavin C, vitexin, isovitexin, apigenin, kaempferol, quercetin, luteolin, cinnamaldehyde, and orientin (claim 7).
Leone-Bay teaches a method of reducing or eliminating one or more symptoms of a disease or disorder in a human subject, wherein said disease or disorder is acquired hypothyroidism, acute gastritis, addiction, ADHD, agoraphobia, AIDS, AIDS-related anorexia, alcoholism, Alzheimer's disease, amyotrophic lateral sclerosis (ALS), ankyloses, anxiety, arthritis, Asperger's syndrome, asthma, atherosclerosis, autism, auto-immune diseases, bacterial infections, bipolar disorder, bone loss, blood disorders, brain injury/stroke, cachexia, cancer, carpal tunnel syndrome, cerebral palsy, cervical disk disease, cervicobrachial syndrome, chronic fatigue syndrome, chronic pain, cluster headache, conjunctivitis, Crohn's disease, cystic fibrosis, depression, dermatitis, diabetes, dystonia, eating disorders, eczema, epilepsy, fever, fibromyalgia, flu, fungal infection, gastrointestinal disorders, glaucoma, glioma, Graves' disease, heart disease hepatitis, herpes, Huntington's disease, hypertension, impotence, incontinence, infant mortality, inflammation, inflammatory bowel disease (IBD), insomnia, liver fibrosis, mad cow disease, menopause, metabolic disorders, migraine headaches, motion sickness, MRSA, multiple sclerosis (MS), muscular dystrophy, mucosal lesions, nail patella syndrome, nausea and vomiting associated with cancer chemotherapy, neuroinflammation, nicotine addiction, obesity, obsessive compulsive disorder (OCD), osteoporosis, osteopenia, pain, pancreatitis, panic disorder, Parkinson's disease, periodontal disease, peripheral neuropathy, phantom limb pain, poison ivy allergy, premenstrual syndrome (PMS), proximal myotonic myopathy, post-traumatic stress disorder (PTSD), psoriasis, Raynaud's disease, restless leg syndrome, schizophrenia, scleroderma, septic shock, shingles herpes zoster), sickle cell disease, seizures, sleep apnea, sleep disorders, spinal injuries, stress, stuttering, temporomandibular joint disorder (TMJ), tension headaches, tinnitus, Tourette's syndrome, traumatic memories, wasting syndrome, or withdrawal syndrome (claim 73).
Leone-Bay does not specifically teach determining whether said subject has a high inflammatory state and/or microglial activation state (claim 1), more specifically wherein said high inflammatory/microglia state, is characterized by any one of: (a) plasma C-reactive protein (CRP) levels greater than 1 mg/L; (b) plasma IL-1b levels greater than 60 pg/ml; (c) plasma IL-6 levels greater than 2.0 pg/ml; (d) plasma TNFα levels greater than 3.8 pg/ml; (e) plasma CCL11 (eotaxin-1) levels greater than 72 pg/ml; (g) plasma IL-8 levels greater than 12.0 pg/ml; (h) plasma MIP-1α greater than 7.1 pg/ml; (i) plasma MCP1 levels greater than 80.0 pg/ml, (j) plasma RANTES greater than 2978 pg/ml, and any combination thereof, as required by the limitations of claim 2.
Yirmiya, teaches the peripheral and central triggers of microglial activation can induce the development of depression (page 645, Figure 6).
Yirmiya, teaches patients with high levels of inflammatory markers (e.g., CRP, TNF-a, IL-1, IL-6) should be treated with microglia-suppressive drugs such as TNF-a inhibitors (infliximab), COX-2 inhibitor (celecoxib) (page 653).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have administered the CBD/THC containing formulation for the treatment of depression as taught by Leone-Bay and envisioned employing the therapeutic formulation to a patient population characterized as exhibiting one or more of the specific plasma markers of claim 2. The motivation, provided by Yirmiya, teaches patients with high levels of inflammatory markers (e.g., CRP, TNF-a, IL-1, IL-6) should be treated with microglia-suppressive drugs. Therefore, the skilled artisan would have found it obvious that a patient population suffering from depression would exhibit high levels of inflammatory markers and increased microglial status, thereby benefitting from the antidepressive formulations of Leone-Bay.
Thus, based on the foregoing reasons, the instant claims are deemed unpatentable over the cited reference.
Conclusion
Claims 1-3, 5, 7-8, 13, 17, 46, 47, 50, 53, and 54 are not allowed.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to Sahar Javanmard whose telephone number is (571)270-3280. The examiner can normally be reached on Monday-Friday, 9:00-5:00 EST.
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/SAHAR JAVANMARD/Primary Examiner, Art Unit 1627