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
Status of claims
The amendment filed on August 14, 2025 is acknowledged. Claims 1, 7, 12-17, 23-26, and 28-29 have been canceled. Claims 2-6, 8-11, 18-22, 27 and 30-31 are under examination in the instant office action.
Applicants' arguments, filed on August 14, 2025, have been fully considered but they are moot in view of a new ground of rejection. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied They constitute the complete set presently being applied to the instant application.
Duplicate Claims, Warning
Applicant is advised that should claim 2 be found allowable, claim 31 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 706.03(k). While there is a slight difference in wording of the preamble, the body of the claim recites the same method step, i.e., administering the same compound in the same dose to the same patient population (i.e., a subject having Aicardi syndrome). Thus, there is no difference in the scope and they both cover the same method.
Applicant stated that both claims are maintained until allowability of the claims is otherwise indicated. Thus, the objection is maintained.
Claim Rejections - 35 USC § 112 (b)
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.
Claim 8-9 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 pre-AIA the applicant regards as the invention.
Claims 8-9 recite “the extract” but claim 2 from which they depend does not recite “extract”. Thus, there is insufficient antecedent basis for this limitation. Accordingly, they are not further examined because the scope of the claims cannot be determined.
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 of this title, 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.
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 2-6, 10-11, 18-22, 27 and 30-31 are rejected under 35 U.S.C. 103 as being unpatentable over US 2015/0343071 (hereafter, Vangara) and Porter et al. (hereafter, Porter; Epilepsy & Behavior, 2013, 29,574-577, cited in the IDS filed on 5/5/2021) in view of Rosser et al. (PEDIATRIC NEUROLOGY, 27 (5): 343-346, 2002) and anonymous NPL publication titled “Cannabidiol Therapy for Aicardi Syndrome” (August 2014, cited in the IDS filed on 5/5/2021; hereafter, CBD NPL).
Vangara discloses formulations containing substantially pure cannabidiol (CBD) which has a purity of greater than 98%, more preferably greater than 99.5% pure and methods of using a substantially pure, synthetically synthesized cannabidiol for treat Dravet Syndrome, Lennox Gastaut Syndrome, mycolonic seizures, juvenile mycolonic epilepsy, refractory epilepsy, juvenile spasms, West syndrome, refractory infantile spasms, or infantile spasms (abstract, [0023], [0046], [0012], [0162], and claim 26).
Vangara teaches that commercially available cannabidiol is usually contaminated with delta-9-tetrahydrocannabinol (THC) and the presence of THC can be a concern because THC is regulated by the United States Drug Enforcement Administration as a Schedule I Drug and is a hallucinogen, thus there is a need for a substantially pure synthetically synthesized cannabidiol that does not contain THC ([0006]). Vangara further teaches that Applicant's cannabidiol has a high purity level and is substantially free of Schedule I drugs, including THC, wherein “substantially free of delta-9-tetrahydrocannabinol” refers to a preparation of cannabidiol having most preferably less than 0.1% of delta-9-tetrahydrocannabinol ([0090] and [0163]).
Vangara teaches that substantially pure cannabidiol formulations are especially suitable for treatment of epilepsy and discloses anticonvulsive effects in a study model for generalized tonic-clonic seizures and therapy-resistant partial seizures ([0018], [0210], Example 8 and 10-11).
Vangara discloses the formulation further comprises sweeteners and flavoring agent ([0032]-[0033]). Vangara further discloses formulations comprising sucralose (sweetener). ethanol (cosolvent), propylene glycol, polyethylene glycol 400 (solvent) and flavoring agent, ([0178] and [0179]). Also, Vangara discloses a formulation comprising sesame oil as solvent and ethanol as co-solvent ([0182] and Table 24, Formulation #LF3).
Vangara discloses stable pharmaceutical formulations for oral administration comprise from about 0.1 to about 40% (1 mg/ml to 400 mg/ml) of a cannabinoid and from about 10 to about 95% of a lipid ([0011]). The range overlaps with those recited in claim 22.
Similar to Vangara, Porter teaches the use of cannabidiol-enriched cannabis (pure CBD) in children with treatment-resistant epilepsy such as Dravet syndrome (DS), Lennox–Gastaut syndrome (LGS), Doose Syndrome, or idiopathic epilepsy (IE) (abstract). Porter teaches that the children experienced a variety of seizure types including focal, tonic–clonic, myoclonic, atonic, and infantile spasms and some children experienced treatment-resistant epilepsy or intractable seizure before trying cannabidiol-enriched cannabis (p575, Results). Porter discloses that treatment with pure CBD was found to result in: i) complete reduction in seizure frequency (2 patients, 11%); ii) greater than 80% reduction in seizure frequency (8 patients, 42%); and iii) 25-60% reduction in seizure frequency (6 patients, 32%) and other beneficial effects included increased alertness, better mood, and improved sleep (abstract and table 1).
Porter further teaches that the dosages of cannabidiol ranged from less than 0.5 mg/kg/day to 28.6 mg/kg/day and the dosages of THC contained within those samples were reported to range from 0 to 0.8 mg/kg/day (p575, col 1, para 1). When the dosage of THC contained within those samples is 0, it means 100 % pure CBD (Results). Also, Porter discloses administering 98.9% w/w purity of CBD (see Table 1, patient 14, 7 mg/kg/day CBD + 0.08 mg/kg/day THC, i.e., 7/7.08 x 100 = 98.9%), to DS patient (abstract and p575, Results). The duration of cannabidiol-enriched cannabis administration ranged from two weeks to over one year (p575, col 1, para 1).
Porter further teaches that childhood epilepsies beginning in the first few years of life are frequently characterized by seizures that are resistant to available treatments, including antiepileptic drugs (AEDs), ketogenic diet, high doses of steroids, and surgery (p574, col 1, para 1).
Vangara or Porter does not specifically disclose that the subject has Aicardi syndrome.
Similar to the above childhood epilepsies such as Dravet syndrome, Lennox–Gastaut syndrome (LGS), and Doose Syndrome taught by Vangara and Porter, it was known in the art that Aicardi syndrome is a childhood epilepsy characterized by infantile spasms and usually intractable epilepsy as evidenced by Rosser et al. (abstract). Rosser et al. also disclose that seizure types for patients having Aicardi syndrome include infantile spasms, myoclonic, mixed, generalized tonic-clonic, focal/complex partial seizures, atonic, tonic, and atypical absence seizure types (p344, col 2, para 2). Thus, one of ordinary skill in the art would have recognized that Aicardi syndrome shares similar clinical features of those childhood epilepsies conditions such as Dravet syndrome, Lennox–Gastaut syndrome (LGS), and Doose Syndrome taught by Vangara and Porter.
In addition, the CBD NPL explicitly discloses the use of CBD for treating Aicardi syndrome (title). The CBD document teaches that Aicardi syndrome was named for Dr. Jean Dennis Aicardi who treated eight female children with infantile spasms (p1, para 1). The CBD NPL further teaches that the anecdotal reports from patients using therapeutic doses of CBD are very positive and patients have seen improvement in the quality and duration of seizures, improved focus and appears more alerts (p3, para 1). It further discloses that the recommended therapeutic dose is 3 mg/kg, 200 mg daily for adults and 50 mg for children (p3, para 3). Also, it teaches that no toxicity has been reported in human clinical CBD clinical trials relating to seizure (p4, para 1).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the pure CBD of Vangara and Porter for treating seizure in a patient having Aicardi syndrome because of the following reasons. Vangara teaches that substantially pure CBD is useful for treating childhood/treatment-resistant epilepsies such as Dravet syndrome, Lennox–Gastaut syndrome (LGS), and Doose Syndrome and discloses that anticonvulsive effects in a study model for generalized tonic-clonic seizures and therapy-resistant partial seizures. Also, Porter teaches the use of pure CBD without THC for treating children suffering from the same childhood/treatment-resistant epilepsies as disclosed in Vangara and specifically discloses that the treatment with pure CBD resulted in complete reduction in seizure frequency or greater than 60% or 80% reduction in seizure frequency. Aicardi syndrome shares similar clinical features of those childhood epilepsies conditions of Vangara and Porter as evidenced by Rosser et al. In addition, the CBD NPL already suggests the use of CBD for treating children having Aicardi syndrome with infantile spasms while it does not disclose purity of CBD in the compositions used for the therapy. Thus, one of ordinary skill in the art would have been motivated to use the formulation comprising substantially pure CBD taught by Vangara and Porter for seizures in patients having Aicardi syndrome because the treatment with pure CBD was taught to be effective for reduction in seizure frequency in childhood/treatment-resistant epilepsies similar to Aicardi syndrome. The skilled artisan would have reasonably expected that the CBD formulation would be similarly effective for treating intractable childhood seizure and infantile spasm in Aicardi syndrome without toxicity or psychoactive and abuse potential.
As to the CBD dosing amount recited in amended claims 2, 11, 27 and 30-31, Porter teaches that the dosages of cannabidiol ranged from less than 0.5 mg/kg/day to 28.6 mg/kg/day. While Porter does not teach Aicardi syndrome, Porter discloses the CBD dosing range effective for childhood seizures (epilepsies) similar to Aicardi syndrome. Also, the CBD NPL disclose that the recommended therapeutic dose is 3 mg/kg, 200 mg daily for adults and 50 mg for children. Thus, the prior art references in combination teaches and suggests the dose range which overlap or close to those claims. Based on the dose range disclosed in the prior art references in combination, it would have been prima facie obvious to optimize a dose suitable for treating seizures in Aicardi syndrome depending on severity of individual patients’ age and condition. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Also, it would have been obvious to a person of ordinary skill in the art to start a lower dose and to gradually increase the dose over time for attaining a desired response based on the ranges taught by the prior art references in combination. In addition, it is well-established that merely selecting proportions and ranges is not patentable absent a showing of criticality. In re Becket, 33 USPQ 33; In re Russell, 169 USPQ 426. “[W]here 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); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”)
Double Patenting Rejections
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 2-6, 10-11, 18-22, 27 and 30-31 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-15 of US patent 10,765,643.
Although the conflicting claims are not identical, they are not patentably distinct from each other because the claims of the patent are also drawn to a method of treating seizures in a subject having Aicardi Syndrome comprising administering to the subject in need thereof a composition comprising cannabidiol (CBD) at a concentration ranging from about 25 mg/ml to about 100 mg/ml, wherein the CBD has the same purity level as claimed and is administered at the same dose range.
As such, the instant claims would have been anticipated by or obvious over the claims of the patent.
Response to Applicants’ argument:
Applicant's request that the Double Patenting rejection be held in abeyance until the claims are held to be otherwise patentable is noted, however, such request is not a persuasive argument, thus the ODP rejections are properly maintained in this Office Action.
Claims 2-6, 10-11, 18-22, 27 and 30-31 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-17 of US patent 11,419,829.
Although the conflicting claims are not identical, they are not patentably distinct from each other because the claims of the patent are also drawn to a method of treating epilepsy in a subject having Aicardi Syndrome or Lennox Gastaut syndrome comprising administering CBD with fenfluramine wherein the CBD has the same purity level as claimed and the composition comprises less than 0.15% (w/w) THC.
As such, the instant claims are anticipated by or would have been obvious over the claims of the patent.
Response to Applicants’ argument:
Applicant's request that the Double Patenting rejection be held in abeyance until the claims are held to be otherwise patentable is noted, however, such request is not a persuasive argument, thus the ODP rejections are properly maintained in this Office Action.
The provisional rejection of Claims 2-6, 8-11, 18-22, 27 and 30-31 on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 21-46 of co-pending US Application No. 18/762588 is hereby withdrawn in view of the abandonment of the ‘588 application.
Conclusion
No claims are allowed.
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/BONG-SOOK BAEK/Primary Examiner, Art Unit 1611