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 .
DETAILED ACTION
The office acknowledges Applicants filing of the claim amendments on 8/25/2025. Claims 1-14 has been cancelled and new claims 15-27 has been added. Claims 15-27 are pending and are examined based on the merits herein.
Information Disclosure Statement
The information disclosure statement(s) (IDS) filed on 9/11/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS is being considered by the Examiner.
Application Priority
This application filed 01/19/2023 is a National Stage entry of PCT/EP2021/ 069794, International Filing Date: 07/15/2021, claims foreign priority to 2011123.3, filed 07/20/2020.
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 15-27 are rejected under 35 U.S.C. 103 as being unpatentable over Geoffrey et al. (IDS: GB 2574321, publication date: 4/12/2019, Wright et al. (IDS: GB 2551986, publication date: Oct 1 2018) and Dizon (IDS: BMC Pediatrics, 2019).
Geoffrey explicitly teach cannabidiol (CBD) preparation comprising greater than or equal to 98% (w/w) CBD and less than or equal to 2% (w/w) other cannabinoids, wherein the less than or equal to 2% (w/w) other cannabinoids comprise the cannabinoids tetrahydrocannabinol (THC), cannabidiol-C1 (CBD-C1); cannabidivarin (CBDV); and cannabidiol-C4 (CBD-C4), and wherein the THC is present as a mixture of trans-THC and cis-THC, for use in the treatment of neonatal hypoxic-ischemic encephalopathy (NHIE) (See claim 1, abstract). The reference teach at least one of the cannabinoids present in the CBD preparation is isolated from cannabis plant material (See claims 14-16) or at least one of the cannabinoids present in the CBD preparation is prepared synthetically (claim 29). It is taught that CBD preparation or a pharmaceutical composition is administered as one or more doses to provide about 5 mg/kg/day of CBD, 20 mg/kg/day, 25 mg/kg/day or 50 mg/kg/day ([0207]). Geoffrey also teach the CBD preparation is useful for treating wherein the epilepsy is Dravet’s syndrome.
Wright teach an aqueous parenteral cannabinoid containing formulation comprising a cannabinoid, wherein the cannabinoid is selected from: cannabidiol (CBD), tetrahydrocannabinol (THC); wherein the cannabinoid is present in an amount of 0.3 to 50mg/ml; wherein the cannabinoid is a natural or a synthetic cannabinoid (See claims 1-5). Wright teach a method of treating a subject comprising administering an aqueous parenteral cannabinoid formulation; wherein the aqueous parenteral cannabinoid formulation is delivered by injection; the subject is a human; status epilepticus; for use as anticonvulsive; for use in the treatment of newborn hypoxic-ischemic encephalopathy (NHIE) (See claims 36, 38, 41, 44-46). The reference is explicit in teaching that the formulation can comprise one or more cannabinoid selected from cannabidiol (CBD), tetrahydrocannabinol (THC) (See abstract).
Dizon teach that seizures occur in 26–65% of neonates with hypoxic-ischemic encephalopathy (HIE) (p 1, para 1); antileptics that can be used in the treatment of seizures include levetiracetam (see p 1, Results).
From the teachings of Geoffrey, Wright and Dizon, a skilled artisan before the effective filing date of the invention would have found it obvious to arrive at the claimed method because (i) Geoffrey teach cannabidiol (CBD) preparation comprising greater than or equal to 98% (w/w) CBD and less than or equal to 2% (w/w) other cannabinoids, e.g. tetrahydrocannabinol and the formulation can be used to treat NHIE (ii) Wright teach formulation that includes a combination cannabidiol (CBD), tetrahydrocannabinol (THC) for treating newborn hypoxic-ischemic encephalopathy and status epilepticus; (iii) Dizon is explicit in teaching that seizures are associated with HIE and antileptics, e.g. levetiracetam can be used for treating epileptic seizures. It is noted that a person skilled in the art would have found it obvious to administer a formulation comprising CBD (98%) and THC (<2%) to treat NHIE. Administration of the formulation comprising CBD and THC to subjects with NHIE as claimed would result in treating seizures in those subjects. A person skilled in the art would have been motivated to arrive at the claimed method with a reasonable expectation of success and to treat symptoms of NHIE including different types of seizures, e.g. tonic. Thus claims 15-16 are addressed by the teachings of the prior art. Claim 17 is addressed by Geoffrey’s teachings. As to claims 18-19, from the teachings of Dizon a person skilled in the art would have found it obvious to administer an anti-epileptic agent such as levetiracetam along with the CBD (98%) and THC (2%) formulation to treat seizures in subjects with NHIE with a reasonable expectation of success. Claims 20-23 are addressed by Geoffrey’s teaching of at least one of the cannabinoids present in the CBD preparation is isolated from cannabis plant material or can be prepared synthetically. Claims 24-27 are addressed by Geoffrey’s teaching of doses of CBD, 10, 20, 25 50 mg/kg/day. Hence a skilled artisan would have found it obvious to administer such dosage amounts of CBD formulation to subjects with NHIE. Further it is within the skill of an artisan to routinely adjust the dosage amount(s) based on the condition(s) to be treated, age of the subject etc. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Thus, it would have been obvious to one of ordinary skill in the art to arrive at the claimed dosage amounts by routine experimentation.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 21, 23 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 21, 23 recite a limitation of ‘at least a portion of at least one of the cannabinoids’. The specification does not define in regards to the portion or at least a portion. In general, portion can be defined as ‘an often limited part of a whole’. It is not clear what portions or amount of what cannabinoids need to be included in the preparation. Is there a specific amount or portion that is included in the preparation? Clarification is required.
Note: For examination purposes the claims have been interpreted as at least one of the cannabinoids present in the CBD preparation is isolated from cannabis plant material or prepared synthetically.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 15-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of US 10220005 (‘005) in view Geoffrey et al. (IDS: GB 2574321, publication date: 4/12/2019, and Dizon (IDS: BMC Pediatrics, 2019).
The instant claims are directed to a method of treating seizures associated with hypoxic ischaemic encephalopathy (HIE) or anoxia at birth, comprising administering a cannabidiol (CBD) preparation to a patient in need thereof, wherein the CBD preparation comprises greater than 95% (w/w) CBD and between 0.01 and 0.15% (w/w) tetrahydrocannabinol (THC). The dependent claims are limited to type of seizures, co-administration of anti-epileptic drugs, specific anti-epileptic drugs, isolation of CBD from plant or synthetic material, dose of CBD to be administered.
‘005 reference claims are directed to a method for treatment of newborn hypoxic-ischemic encephalopathy (NHIE) comprising administering to a newborn human suffering from NHIE a combination of cannabidiol (CBD) with therapeutic hypothermia, wherein the CBD is a non-CB1 agonist; wherein the CBD is in the form of a plant extract; wherein the CBD is in a pure or isolated form.
‘005 reference is not explicit in teaching THC in the formulation or treatment of seizures in the NHIE subject.
Geoffrey and Dizon teachings as discussed above.
From the teachings of Geoffrey it is obvious that the CBD material (plant or synthetic) might contain some amounts of other cannabinoids, e.g. THC. Further the reference teaches formulation comprising 98% CBD and about 2% other cannabinoids, including THC in the formulation that can be used in the method of treating NHIE. Dizon is explicit in teaching that seizures occur in subjects with NHIE. It is noted that seizures are associated with NHIE and hence administration of the same agent to the same set of subjects will result in treating seizures including the sub types. A person skilled in the art would have found it obvious to arrive at claims 15-16 from the teachings of the patent and from the references. Claim 17 is addressed by Geoffrey’s teachings. As to claims 18-19, from the teachings of Dizon a person skilled in the art would have found it obvious to administer an anti-epileptic agent such as levetiracetam along with the CBD (98%) and THC (2%) formulation to treat seizures in subjects with NHIE with a reasonable expectation of success. Claims 20-23 are addressed by the patent and/or Geoffrey’s teaching of at least one of the cannabinoids present in the CBD preparation is isolated from cannabis plant material or can be prepared synthetically. Claims 24-27 are addressed by Geoffrey’s teaching of doses of CBD, 10, 20, 25 50 mg/kg/day. Hence a skilled artisan would have found it obvious to administer such dosage amounts of CBD formulation to subjects with NHIE. Further it is within the skill of an artisan to routinely adjust the dosage amount(s) based on the condition(s) to be treated, age of the subject etc. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Thus, it would have been obvious to one of ordinary skill in the art to arrive at the claimed dosage amounts by routine experimentation.
Claims 15-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of US 11207292 (‘292) or claims 1-30 of US 11865102 (‘102) in view Geoffrey et al. (IDS: GB 2574321, publication date: 4/12/2019, and Dizon (IDS: BMC Pediatrics, 2019).
The instant claims as above.
‘292 reference claims are directed to a cannabidiol (CBD) preparation comprising greater than or equal to 95% (w/w) CBD based on total amount of cannabinoid in the preparation and the remainder comprises other cannabinoids, wherein the other cannabinoids comprise tetrahydrocannabinol (THC); comprising not more than 1.5% (w/w) of THC based on total amount of cannabinoid in the preparation; comprises other cannabinoids, about 0.1% to about 0.15% (w/w) CBD-C1; 0.2% to about 0.8% (w/w) CBDV, about 0.3% to about 0.4% (w/w) CBD-C4. Also claimed is to a method of treating epilepsy in a subject in need thereof, comprising administering a therapeutically effective amount of the CBD preparation of claim 1, wherein the epilepsy is Dravet syndrome, Lennox Gastaut syndrome, Doose syndrome, or tuberous sclerosis complex (TSC); the CBD preparation provides a dose of CBD ranging from about 5 mg/kg/day to about 50 mg/kg/day; CBD preparation are isolated from cannabis plant material; wherein at least a portion of at least one of the cannabinoids present in the CBD preparation is prepared synthetically.
‘102 reference claims are directed to a cannabidiol (CBD) preparation comprising greater than or equal to 90% (w/w) CBD based on total amount of cannabinoid in the preparation and the remainder comprises other cannabinoids, wherein the other cannabinoids comprise tetrahydrocannabinol (THC); comprising not more than 1.5% (w/w) THC based on total amount of cannabinoid in the preparation; comprises other cannabinoids, about 0.1% to about 0.15% (w/w) CBD-C1; 0.2% to about 0.8% (w/w) CBDV, about 0.3% to about 0.4% (w/w) CBD-C4; method of treating epilepsy in a subject in need thereof, comprising administering a therapeutically effective amount of the CBD preparation of claim 1, wherein the epilepsy is Dravet syndrome, Lennox Gastaut syndrome, Doose syndrome, or tuberous sclerosis complex; wherein the wherein the therapeutically effective amount of the CBD preparation provides a dose of CBD of 10 mg/kg/day, 20 mg/kg/day, or 25 mg/kg/day. wherein at least a portion of the CBD present in the CBD preparation is isolated from cannabis plant material; wherein the cannabinoids present in the CBD preparation are prepared synthetically.
‘292 or ‘102 reference claims are not explicit in teaching treating the seizures in NHIE subjects with the CBD formulation.
Geoffrey and Dizon teachings as discussed above.
From the teachings of Geoffrey it is obvious that CBD preparation can be used in treating epilepsy in Dravet’s syndrome and NHIE. Dizon is explicit in teaching that seizures occur in subjects with NHIE. It is noted that seizures are associated with NHIE and hence administration of the same agent to the same set of subjects will result in treating seizures including the sub types. A person skilled in the art would have found it obvious to treat seizures in NHIE subjects with CBD preparation and arrive at claims 15-16 from the teachings of the patent and from the references. Claim 17 is addressed by Geoffrey’s teachings. As to claims 18-19, from the teachings of Dizon a person skilled in the art would have found it obvious to administer an anti-epileptic agent such as levetiracetam along with the CBD (98%) and THC (2%) formulation to treat seizures in subjects with NHIE with a reasonable expectation of success. Claims 20-23 are addressed by patent’s teaching of at least one of the cannabinoids present in the CBD preparation is isolated from cannabis plant material or can be prepared synthetically. Claims 24-27 are addressed by reference claims teaching of dose of CBD ranging from about 5 mg/kg/day to about 50 mg/kg/day. A person skilled in the art would have found it obvious to administer the claimed dosage amounts to subjects with NHIE and treat seizures associated with the disorder. Further it is within the skill of an artisan to routinely adjust the dosage amount(s) based on the condition(s) to be treated, age of the subject etc. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Thus, it would have been obvious to one of ordinary skill in the art to arrive at the claimed dosage amounts by routine experimentation.
Claims 15-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-41 of co-pending Application No. 18446405 (‘405) in view Geoffrey et al. (IDS: GB 2574321, publication date: 4/12/2019, Wright et al. (IDS: GB 2551986, publication date: Oct 1 2018) and Dizon (IDS: BMC Pediatrics, 2019).
The instant claims as above.
‘405 reference claims are directed to a botanical drug substance comprising greater than or equal to 90% (w/w) CBD based on total amount of cannabinoid in the botanical drug substance and the remainder comprises other cannabinoids, wherein the other cannabinoids comprise tetrahydrocannabinol (THC), wherein the THC is present as a mixture of trans-THC and cis-THC; botanical drug substance of comprising not more than 1.5% (w/w) THC based on total amount of cannabinoid; comprising about 0.1% to about 0.15% (w/w) CBD-C 1 based on total amount of cannabinoid; comprising about 0.2% to about 0.8% (w/w) CBDV based on total amount of cannabinoid; about 0.3% to about 0.4% (w/w) CBD-C4 based on total amount of cannabinoid; at least a portion of the CBD present in the preparation botanical drug substance is isolated from cannabis plant material; at least a portion of the THC present in the CBD preparation botanical drug substance is isolated from cannabis plant material; at least a portion of at least one of the cannabinoids present in the CBD preparation botanical drug substance is prepared synthetically; and a pharmaceutical composition comprising the cannabinoid(s).
The reference claims are not explicit in teaching treating the seizures in NHIE subjects with the formulation comprising CBD and THC.
Geoffrey, Wright and Dizon teachings as discussed above.
From the teachings of Geoffrey and Wright, it is obvious that CBD preparation can be used in treating NHIE. Dizon is explicit in teaching that seizures occur in subjects with NHIE. It is noted that seizures are associated with NHIE and hence administration of the same agent to the same set of subjects will result in treating seizures including the sub types. A person skilled in the art would have found it obvious to treat seizures in NHIE subjects with CBD preparation as claimed and arrive at claims 15-16 from the teachings of the patent and from the references. Claim 17 is addressed by Geoffrey’s teachings. As to claims 18-19, from the teachings of Dizon a person skilled in the art would have found it obvious to administer an anti-epileptic agent such as levetiracetam along with the CBD (98%) and THC (2%) formulation to treat seizures in subjects with NHIE with a reasonable expectation of success. Claims 20-23 are addressed by patent’s teaching of at least one of the cannabinoids present in the CBD preparation is isolated from cannabis plant material or can be prepared synthetically. Claims 24-27 are addressed by Geoffrey’s teaching of dose of CBD ranging from about 5 mg/kg/day to about 50 mg/kg/day. A person skilled in the art would have found it obvious to administer the claimed dosage amounts to subjects with NHIE and treat seizures associated with the disorder. Further it is within the skill of an artisan to routinely adjust the dosage amount(s) based on the condition(s) to be treated, age of the subject etc. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Thus, it would have been obvious to one of ordinary skill in the art to arrive at the claimed dosage amounts by routine experimentation.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to UMAMAHESWARI RAMACHANDRAN whose telephone number is (571)272-9926. The examiner can normally be reached M-F- 8:30-5:00 PM (PST).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney Klinkel can be reached at 5712705239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/ patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Umamaheswari Ramachandran/Primary Examiner, Art Unit 1627