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 .
Election/Restrictions
Applicant’s election without traverse of generalized anxiety disorder in the reply filed on 6/3/2026 is acknowledged.
Therefore, claims 4 and 5 are withdrawn from further consideration as being drawn to non-elected inventions.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-3, 6-16, 25, 30, 31 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by US 2016/0256411 (Afgin)-of record.
Afgin teaches a method of treating an emotional disorder in a subject in need thereof (para [0011]. It is an object of the present invention to provide a method for the treatment of anxiety and other mood disorders; PTSD; Anxiety disorders including PTSD are emotional disorders; see instant claim 2, the emotional disorder is an anxiety disorder; and see instant claim 3, the anxiety disorder is selected from: Post Traumatic Stress Disorder (PTSD)), the method comprising administering to the subject (i) ketamine, norketamine, 6- hydroxynorketamine, or a pharmaceutically acceptable salt thereof, and (ii) cannabis or a cannabinoid (para [0012], The above objects and others are attained by virtue of the present invention, which is directed in part to a method of treating a disease state or condition in a human patient via topical regional neuro-affective (TRNA) or regional neuroaffective (RNA) therapy via administration of a drug at the back of the neck region, or the back of the neck. e.g., at the hairline (BONATH); and para [0013], The drug is one or more cannabinoids; and para [0020], the method further comprises further comprises topically administering at the back of the neck region (e.g., BONATH) together with, sequentially, or simultaneously but in separate formulations, an additional drug(s); and para [0137], In yet other embodiments, the additional drug(s) may be an NMDA receptor antagonist. Phencyclidine, ketamine, and dextromethorphan, are used as recreational drugs. Atgin subanesthetic doses, however, these drugs have mild stimulant effects), wherein the ketamine and cannabinoid are administered together (para [0020], the method further comprises further comprises topically administering at the back of the neck region (e.g., BONATH) together with, sequentially, or simultaneously but in separate formulations, an additional drug(s)), wherein the cannabinoid is provided in an amount that is effective for the treatment of the emotional disorder (para [0156], the topical formulation of the present invention comprises a drug in an amount which is therapeutically effective when administered topically; and para [0047], For purposes of the present invention "therapeutically effective' or "effective" amount is meant to be a non-toxic but sufficient amount of a cannabinoid compound(s) to provide the desired therapeutic effect), but does not state that the ketamine and cannabinoid are each in an amount that together is effective for the treatment of the emotional disorder.
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.
Claims 1-3, 6-16, 25, 30, 31 are rejected under 35 U.S.C. 103 as being unpatentable over US 2016/0256411 (Afgin) in view of US 2017/0355663 (Amorsa), US 2012/0264703 (Khan), US 2017/0127727 (Syqe Medical), US 2015/0018365 (Acha), US 2014/0107396 (ElectroCore) and US 2016/0101069 (Icahn)-all of record.
Afgin teaches a method of treating an emotional disorder in a subject in need thereof (para [0011]. It is an object of the present invention to provide a method for the treatment of anxiety and other mood disorders; PTSD; Anxiety disorders including PTSD are emotional disorders; see instant claim 2, the emotional disorder is an anxiety disorder; and see instant claim 3, the anxiety disorder is selected from: Post Traumatic Stress Disorder (PTSD)), the method comprising administering to the subject (i) ketamine, norketamine, 6- hydroxynorketamine, or a pharmaceutically acceptable salt thereof, and (ii) cannabis or a cannabinoid (para [0012], The above objects and others are attained by virtue of the present invention, which is directed in part to a method of treating a disease state or condition in a human patient via topical regional neuro-affective (TRNA) or regional neuroaffective (RNA) therapy via administration of a drug at the back of the neck region, or the back of the neck. e.g., at the hairline (BONATH); and para [0013], The drug is one or more cannabinoids; and para [0020], the method further comprises further comprises topically administering at the back of the neck region (e.g., BONATH) together with, sequentially, or simultaneously but in separate formulations, an additional drug(s); and para [0137], In yet other embodiments, the additional drug(s) may be an NMDA receptor antagonist. Phencyclidine, ketamine, and dextromethorphan, are used as recreational drugs. Atgin subanesthetic doses, however, these drugs have mild stimulant effects), wherein the ketamine and cannabinoid are administered together (para [0020], the method further comprises further comprises topically administering at the back of the neck region (e.g., BONATH) together with, sequentially, or simultaneously but in separate formulations, an additional drug(s)), wherein the cannabinoid is provided in an amount that is effective for the treatment of the emotional disorder (para [0156], the topical formulation of the present invention comprises a drug in an amount which is therapeutically effective when administered topically; and para [0047], For purposes of the present invention "therapeutically effective' or "effective" amount is meant to be a non-toxic but sufficient amount of a cannabinoid compound(s) to provide the desired therapeutic effect), but does not state that the ketamine and cannabinoid are each in an amount that together is effective for the treatment of the emotional disorder.
It would have been obvious to one of ordinary skill in the art to use ketamine to treat the emotional disorder because ketamine is effective in the treatment of a variety of emotional disorders (see US 2017/0355663 A1 to Amorsa Thereutics, inc., para [0258], the pharmaceutical composition comprises an amount of ketamine, norketamine, or a derivative thereof, or any of the compounds described herein, or a pharmaceutically acceptable salt thereof, therapeutically effective for the treatment of depression; and para [0264], the pharmaceutical composition comprises an amount of ketamine, norketamine, or a derivative thereof, or any of the compounds described herein, or a pharmaceutically acceptable salt thereof, therapeutically effective for the treatment of depression; and para [0264], the pharmaceutical composition comprises an amount of ketamine, norketamine, or a derivative thereof, or any of the compounds described herein, or a pharmaceutically acceptable salt thereof, therapeutically effective for use in treating post traumatic stress disorder (PTSD); and para [0267], the pharmaceutical composition (e.g., a pharmaceutical composition formulated for oral comprises an amount of ketamine, norketamine, or a derivative thereof, or any of the compounds described herein, or a pharmaceutically acceptable salt thereof, therapeutically effective for use in treating anxiety (e.g., generalized anxiety disorder); Anxiety disorders including PTSD and GAD are emotional disorders; see instant claim 2, the emotional disorder is an anxiety disorder; and see instant claim 3, the anxiety disorder is selected from Generalized Anxiety Disorder (GAD) Post Traumatic Stress Disorder (PTSD)). Further, it would have been obvious to one of ordinary skill in the art to optimize the amount of the ketamine and cannabinoid provided to the subject by routine experimentation in order to improve the treatment of the emotional disorder.
Regarding Claim 2, Afgin teaches the method of claim 1, wherein the emotional disorder is an anxiety disorder (para [0106], Potential clinical applications of cannabinoids applied at the back of the neck in accordance with the present invention include the following PTSD; and see US 2017/0355663 A1 to Amorsa Thereutics, Inc., para [0264], the pharmaceutical composition comprises an amount of ketamine, norketamine, or a derivative thereof, or any of the compounds described herein, or a pharmaceutically acceptable salt thereof, therapeutically effective for use in treating post traumatic stress disorder (PTSD); PTSD is an anxiety disorder; see instant claim 3, the anxiety disorder is selected from: Post Traumatic Stress Disorder (PTSD)).
Regarding Claim 3, Afgin teaches the method of claim 2, wherein the anxiety disorder is selected from Generalized Anxiety Disorder (GAD), Panic Disorder (PD), Social Anxiety Disorder (SAD), Obsessive-Compulsive Disorder (OCD), Specific Phobic Disorders (SPD), Post Traumatic Stress Disorder (PTSD), Agoraphobia, or Separation Anxiety Disorder (SeAD) (para [0106], Potential clinical applications of cannabinoids applied at the back of the neck in accordance with the present invention include the following PTSD; and see US 2017/0355663 A1 to Amorsa Thereutics, Inc., para [0264], the pharmaceutical composition comprises an amount of ketamine, norketamine, or a derivative thereof, or any of the compounds described herein, or a pharmaceutically acceptable salt thereof, therapeutically effective for use in treating post traumatic stress disorder (PTSD)).
Regarding Claim 6, Afgin teaches the method of claim 1, wherein the method comprises ameliorating one or more physical symptoms associated with the emotional disorder, wherein the physical symptoms are selected from headache, migraine, physical symptoms related to the menstrual cycle such as breast tendemess, cramps and headaches, symptoms of somatization disorders, fibromyalgia, various neurologic symptoms and disorders, and pain from a wide variety of causes (para [0011], It is an object of the present invention to provide a method for the treatment of headaches (migraine and tension); peripheral neuropathy; as well as other conditions or disease states mentioned herein or any other disease or condition that may be treated with a cannabinoid), but does not state that the headaches and migraines are symptoms associated with the emotional disorder. It would have been obvious to one of ordinary skill in the art to use the cannabinoid to ameliorate one or more physical symptoms associated with the emotional disorder because headaches are a symptom of anxiety disorders (see US 2012/0264703 A1 to Khan et al., para [0004], Symptoms of anxiety disorders may vary depending on the disorder, but may include headaches). Further, it would have been obvious to one of ordinary skill to use ketamine to treat headaches and migraines associated with the emotional disorder because ketamine is effective in the treatment of migraine headaches (see US 2014/0107398 A1 to ElectroCore, LLC, para [0169], ketamine is also effective in the treatment of migraine headaches).
Regarding Claim 8, Afgin teaches the method of any one of claims 1-6, wherein administration of the cannabis or a cannabinoid to the subject is by a route selected from oral, pulmonary, or transdermal administration (para [0026], the cannabinoid drug(s) is incorporated into a sustained release transdermal delivery system which is capable of delivering from about 0.25 mg to about 1000 mg of the cannabinoid drug(s) through the skin of a human patient over a 24 hour period, the transdermal delivery system being capable of delivering the cannabinoid drug(s) in Such amounts for a time period from about 1 to about 7 days).
Regarding Claim 11, Afgin teaches the method of any one of claims 1-6, wherein the ketamine, norketamine, 6- hydroxynorketamine, or a pharmaceutically acceptable salt thereof, and cannabis or a cannabinoid are concurrently administered once or more daily, once or more every other day, or once or more every. three days (para [0018], The topical pharmaceutical formulation may be administered (applied to the back of the neck region) on a once a day basis, or on a twice a day basis, a three times a day basis, or on a four times a day basis; and para [0161], the topical formulations comprising a drug in an ointment, gel, cream or the like, will typically contain on the order of about 0.001 to about 80% by weight, preferably 0.01 wt. % to 50 wt. % drug (i.e., cannabinoid drug(s) plus optional additional drugs as described herein), but does not state that the rate of drug administration is dependent on the presence and/or severity of the emotional disorder or the physical symptoms of the emotional disorder. It would have been obvious to one of ordinary skill in the art to optimize the rate of drug administration by routine experimentation depending on the presence and/or severity of the emotional disorder or the physical symptoms of the emotional disorder by routine experimentation in order to customize the treatment to the individual progression of a disorder in the subject.
Regarding Claim 14, Afgin teaches the method of any one of claims 1-6, wherein the ketamine and cannabinoid are administered daily (para [0018], The topical pharmaceutical formulation may be administered (applied to the back of the neck region) on a once a day basis, or on a twice a day basis, a three times a day basis, or on a four times a day basis; and para [0161], the topical formulations comprising a drug in an ointment, gel, cream or the like, will typically contain on the order of about 0.001 to about 80% by weight, preferably 0.01 wt. % to 50 wt. % drug (i.e., cannabinoid drug(s) plus optional additional drugs as described herein), but does not teach method wherein the concurrent administration is once daily for a period of from 1 to 10 days, followed by a period of at least two weeks during which no ketamine, norketamine, 6-hydroxynorketamine, or a pharmaceutically acceptable salt thereof, and cannabis or a cannabinoid are concurrently administered to the subject. It would have been obvious to one of ordinary skill in the art to optimize the length of the daily treatment by routine experimentation in order to improve the condition of the subject. Further, it would have been obvious to one of ordinary skill in the art to follow the administration period with a longer period without any drug administration in order to observe the long term effects of the treatment.
Regarding Claim 16, Afgin teaches the method of any one of claims 1-6, wherein the ketamine, norketamine, 6-hydroxynorketamine, or a pharmaceutically acceptable salt thereof, and cannabis or a cannabinoid are concurrently administered to the subject once or more daily and/or in the evening, or in a program of frequency related to the needs of the patient for relief from the emotional disorder or the physical symptoms of the emotional disorder (para [0018], The topical pharmaceutical formulation may be administered (applied to the back of the neck region) on a once a day basis, or on a twice a day basis, a three times a day basis, or on a four times a day basis; and para [0161], the topical formulations comprising a drug in an ointment, gel, cream or the like, will typically contain on the order of about 0.001 to about 80% by weight, preferably 0.01 wt. % to 50 wt. % drug (i.e., cannabinoid drug(s) plus optional additional drugs as described herein).
Claim 7 is obvious over Afgin in view of US 2017/0127727 A1 to Syqe Medical Ltd. (hereinafter "Syqe"). Regarding Claim 7, Afgin teaches the method of any one of claims 1-6, but does not teach the method wherein the cannabis is prepared from a strain of cannabis selected from a Cannabis indica species, a Cannabis sativa species, a hybrid species, a high- tetrahydrocannabinol (THC) species of cannabis, or a high-cannabidiol (CBD) species of cannabis. Syqe teaches a method of pulmonary delivering to a subject at least one pharmacologically active agent being in a plant material (para [0017], According to an aspect of some embodiments of the present disclosure there is provided a method of pulmonary delivering to a subject at least one pharmacologically active agent being in a plant material wherein the at least one pre-determined vaporized amount of the agent is selected so as to achieve at least one pre-determined phar macokinetic (PK) effect and/or at least one pre-determined pharmacodynamic (PD) effect induced by the agent in the Subject), wherein the at least one pharmacologically active agent is a cannabinoid (para [0045], the pharmaco logically active agent includes A9-tetrahydrocannabinol (THC) and cannabidiol (CBD)), wherein the plant material is cannabis sativa of cannabis indica (para [0079], the at least one plant includes Cannabis sativa, Cannabis indica). It would have been obvious to one of ordinary skill in the art to prepare the cannabis from a Cannabis indica species or a Cannabis sativa species because Syqe demostrates that the method is effective for treating the symptoms of an emotional disorder (para [0422], Non-limiting representative medical conditions, treatable by pulmonary delivering a vaporizable pharmaceutically active agent, include anxiety disorders, post-traumatic stress disorder (PTSD); Anxiety disorders including PTSD are emotional disorders; see instant claim 2, the emotional disorder is an anxiety disorder; and see instant claim 3, the anxiety disorder is selected from: Post Traumatic Stress Disorder (PTSD)).
Claims 9-10 are obvious over Afgin in view of US 2016/0101069 A1 to Icahn School of Medicine at Mount Sinai (hereinafter "Icahn"). Regarding Claim 9, Afgin teaches the method of any one of claims 1-6, wherein the administration of the cannabis or a cannabinoid is by a route selected from oral, sublingual, intranasal, intramuscular, intravenous, transdermal, and rectal administration (para [0026], the cannabinoid drug(s) is incorporated into a sustained release transdermal delivery system which is capable of delivering from about 0.25 mg to about 1000 mg of the cannabinoid drug(s) through the skin of a human patient over a 24 hour period, the transdermal delivery system being capable of delivering the cannabinoid drug(s) in Such amounts for a time period from about 1 to about 7 days), but does not teach the method wherein the administration of the ketamine, norketamine, 6-hydroxynorketamine, or a pharmaceutically acceptable salt thereof is by a route selected from oral, sublingual, intranasal, intramuscular, intravenous, transdermal, and rectal administration. Icahn teaches a method of treating a human patient for PTSD, comprising orally administering a composition comprising ketamine (para [0128], In another alternative embodiment, the invention thus provides a method of treating a human patient for PTSD, comprising orally (e.g., liquid or Solid (e.g., lozenge) dosage form) administering a composition comprising ketamine to the patient at a dosage sufficient to reduce or eliminate the symptoms of the PTSD). It would have been obvious to one of ordinary skill in the art to administer the ketamine orally using the composition taught by Icahn because the composition is effective to reduce the symptoms of an emotional disorder (Icahn, para [0128], In another alternative embodiment, the invention thus provides a method of treating a human patient for PTSD, comprising orally (e.g., liquid or Solid (e.g., lozenge) dosage form) administering a composition comprising ketamine to the patient at a dosage sufficient to reduce or eliminate the symptoms of the PTSD; Anxiety disorders including PTSD are emotional disorders; see instant claim 2, the emotional disorder is an anxiety disorder; and see instant claim 3, the anxiety disorder is selected from: Post Traumatic Stress Disorder (PTSD)).
Afgin teaches the method of any one of claims 1-6. Icahn further teaches the method wherein the ketamine, norketamine, 6-hydroxynorketamine, or pharmaceutically acceptable salt thereof, is formulated in a lozenge (para [0128], In another alternative embodiment, the invention thus provides a method of treating a human patient for PTSD, comprising orally (e.g., liquid or Solid (e.g., lozenge) dosage form) administering a composition comprising ketamine to the patient at a dosage sufficient to reduce or eliminate the symptoms of the PTSD).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL V MELLER whose telephone number is (571)272-0967. The examiner can normally be reached M-F 9 am-5:30 pm.
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MICHAEL V. MELLER
Primary Examiner
Art Unit 1655
/MICHAEL V MELLER/Primary Examiner, Art Unit 1655
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