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 .
Response to Arguments
Applicant's arguments filed 07/28/2025 have been fully considered but they are not persuasive. Applicant argues (page 2) prior art of Finley “disclose the use of cannabinoids alone in methods of treatment, with no teaching or suggestion of the further use of any additional active component, and certainly not specifically of both terpenes and herbal preparations”. It is noted Finley teaches cannabis oil compositions (abstract) in which cannabis oil is defined as a mixture of compounds obtained from the extraction of the cannabis plant which includes cannabinoids and terpenes (para. 0053 and 0151). Finley additionally teaches the method of preparing the cannabis extract in certain embodiments further includes one or more terpenes and, in some embodiments, the method further includes combining the cannabis oil (which includes terpenes) or cannabis oil/vitamin E mixture with an essential oil or a carrier oil to produce a cannabis oil composition (para. 0073) and further herbal extracts (0177). The herbal extracts as per previous office action includes the majority of the claimed herbal preparations.
For the above reasons the previous rejections over Finley et al. (WO 2017091764 A1), Kleidon et al. (US 20170172977 A1), Bar-lev (WO 2017168422 A1) and Tamir et al. (WO 2018173049 A1) are maintained.
Applicant has canceled claims 2, 4, 9, 11, 13-18, 20 and added claims 22-34. No new matter is added. Claims 1, 7-8, 10, 12, 19 and 21-34 is now evaluated on its merits.
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.
Claims 1, 7-8, 10, 22-32 and 34 are rejected under 35 U.S.C. 103 as being unpatentable over Finley et al. (WO 2017091764 A1).
Regarding claims 1, 7-8, 10, 22-32 and 34, Finley et al. teaches a method for the treatment of vomiting, nausea, chronic pain, back pain, spasticity, glaucoma, dysmenorrhea, migraines, anxiety disorders, inflammation, fibromyalgia, addiction, epilepsy, depression, Alzheimer's disease, Parkinson's disease, Huntington's disease, multiple sclerosis, other neurodegenerative diseases and increase appetite (para. 0003, 0196, 0203-0204) comprising administering a cannabis oil extracts composition of a cannabinoids of CBD, one or more terpenes and essential oils (para. 0006, 0053, 0073). Of the cannabis oil composition Finley teaches the cannabinoid of CBD at an amount ranging 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 (relevant to claim 22) (para. 0143), terpenes of linalool, bisabolol and nerolidol (para. 0155, 0158, 0162) and total essential oils from about 0.01% (w/w) to about 10% (w/w) (para. 0170).
Finley additionally teaches the cannabis oil composition including one or more herbal extracts from a list which consist of Valeriana Officinalis, Hypericum Perforatum (an essential oil), Viburnum Opulus, Salix Alba, Curcuma longa, Angelica Archangelica, Ganoderma Lucidum, Viscum Album (relevant to claims 7-8, 10, 23-32 and 34) and carrier oils in an amount ranging from about 5% w/w to about 10% w/w (para. 0181-0182). Finley teaches majority of the claimed herbal preparations represented in paragraphs 0175-0178.
Therefore, it would have been obvious for someone of ordinary skill in the art at the time of filling to have made a product from the teachings of Finley to treat the conditions of nausea, lack of appetite, neurogenetic diseases, epilepsy, multiple sclerosis, fibromyalgia, anxiety, pelvic pain, depression, migraine, neuropathic pain, joint paint, spasticity, endometriosis, and addiction. Although Finley does not discreetly identify which herbal preparation is intended for a specific condition, one would have been motivated to treat the conditions as Finley teaches all the conditions mentioned as well as all the herbal preparations that can be used to treat the conditions. Additionally, Finley teaches the essential oil of Hypericum Perforatum within the w/w claimed range and Angelica root which is derived from the herbal extract of Angelica Archangelica. There would be a reasonable expectation of treating the claimed conditions by the teachings of Finley in which the herbal extracts are at least .05 w/w.
Claims 12, 19, 21 and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Finley at al. (WO 2017091764 A1) in view of Kleidon et al. (US 20170172977 A1), Bar-Lev (WO 2017168422 A1), Tamir et al. (WO 2018173049 A1) and May et al. (US 20200253921 A1), published 08/13/2020, which has a provisional priority date of 08/22/2018.
The teachings of Finley et al. are set forth in the above 103 rejections of claims 1, 7-8, 10, 22-32 and 34 and are incorporated herein by reference. Finley additionally teaches herbal preparations of Curcuma longa, Glycyrrhiza Glabra (relevant to claim 12), Humulus Lupulus (relevant to claim 19) and Scutellaria Baicalensis (relevant to claim 21) (para. 0176). Finley does not teach the treatment for Inflammatory bowel disease, ADHD, autism and allergy.
Regarding claim 12, Bar-Lev teaches compositions and methods for treating inflammatory condition of the gastrointestinal (GI) tract, specifically those related to Inflammatory Bowel Disease (IDB) comprising cannabinoids, monoterpenes and sesquiterpenes, oil extracts and a carrier (abstract, example 1 and 2).
Regarding claim 19, Tamir teaches the treatment of autism and prostate cancer (para. 0108) comprising administration of a product containing a cannabinoid (para. 0007) monoterpene of linalool (para. 0010) and a solvent carrier (para. 0047).
Regarding claim 21, Kleidon teaches a method for treatment of allergies and endocrine disorders of Polycystic Ovary Syndrome (PCOS) and oligomenorrhea (para. 0097) comprising administration of a composition containing a cannabinoid (para. 0051), monoterpene of linalool (para. 0054), herbal preparations (para. 0011-0012 and 0092) and an oil carrier fluid (para. 0099).
Regarding claim 33, May teaches a cannabinoid combination of CBD, at least one terpene selected from bisabolol and linalool along with essential oils (para. 0008, 0021) to treat conditions which comprises attention deficit hyperactivity disorder (ADHD) (para. 0142).
Therefore, it would have been obvious to someone of ordinary skill in the art at the time of filling to have used the product of Finley to treat Inflammatory bowel disease, ADHD, autism and allergy taught by Kleidon, Bar-Lev, Tamir and May. One would have been motivated to do so as the teachings of Kleidon, Bar-Lev, Tamir and May effectively uses the same therapeutic agents for the treatment of cancer and other disorder and alignments as Finley. Thus, there would be a reasonable expectation of success for treating the claimed conditions with interchanging the agents taught by Finley, Kleidon, Bar-lev, Tamir and May.
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.
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MIKHAIL O'DONNEL. ROBINSON
Examiner
Art Unit 1627
/MIKHAIL O'DONNEL ROBINSON/Examiner, Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627