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 May 4, 2026 is acknowledged. Claims 1, 7, 12-17, 23-26, and 28-29 have been canceled. New claim 32 is added. Claims 2-6, 8-11, 18-22, 27 and 30-32 are under examination in the instant office action.
Applicants' arguments, filed on May 4, 2026, have been fully considered but they are found to be persuasive. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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 in view of the amendments (amendments in claim 9 and new claim 32). 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 again stated that both claims are maintained until allowability of the claims is otherwise indicated. Thus, the objection is maintained.
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, 8, 10-11, 18-22, 27 and 30-32 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 30-32, 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.”)
Response to Applicant’s arguments
First, Applicant argued that the combined cited art would not lead a skilled person to treat Aicardi syndrome with a reasonable expectation of success because Aicardi syndrome is taught to be associated with seizures intractable to medication. Applicant further argued that if the Office's logic were correct, a drug that is effective for seizures in one form of epilepsy would work for seizures in all epilepsies. Applicant also argued that Rosser's report of the failure of conventional anti-epileptic drugs directly refutes the Office's assertion that an anti-epileptic, such as CBD, can be applied to Aicardi syndrome with a reasonable expectation of success just because of 'similar clinical features."
Second, Applicant argued that the combined cited art would not lead a skilled person to the dosing regimen as claimed. Applicant further stated that only two of the cited references discuss CBD dosing in humans: the CBD NPL (which explicitly teaches doses far below that claimed) and Porter (which is silent as to Aicardi syndrome). Applicant further argued that a skilled person would not be motivated by Porter to treat any of the disclosed syndromes with high purity CBD, much less extend the teachings to Aicardi syndrome because of the following reasons: (1) unreliable nature of Porter's results, and (2) the unreliable reporting of Porter's compositions, which are discussed in the declaration of Dr. Benjamin Whalley (the "Whalley Declaration"). In addition, Applicant argued that the skilled person would also find the anonymous CBD NPL unreliable, for at least the reasons that it contains numerous factual mistakes and is of uncertain provenance.
Third, Applicant argued that teachings related to controlling seizures in one condition would not have been extrapolated to Aicardi syndrome with a reasonable expectation of success. Applicant stated that at the time of filing, CBD was not approved for treatment of seizures in any indication and subsequently, high purity CBD (marketed as Epidiolex®) was approved in 2018 only for the treatment of seizures associated with Lennox- Gastaut syndrome, Dravet syndrome, or Tuberous Sclerosis Complex. Applicant further that despite there being more than 30 anti-seizure medications in use in the United States as of 2024, there are still presently no drugs that are approved by the FDA for the treatment of Aicardi syndrome, meaning those skilled in the art (including the FDA) do not believe the Examiner's logic to be reasonable. In addition, Applicant argued that many anti-epileptic drugs paradoxically worsen other epileptic conditions, highlighting the critical need for condition-specific treatment.
Finally, Applicant argued that the inventors demonstrate surprisingly effective seizure reduction in Aicardi syndrome patients across seizure types.
In response, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). The examiner recognizes that obviousness can only be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988) and In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992). It is also noted that "The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain." In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983) (quoting In re Lemelson, 397 F.2d 1006, 1009, 158 USPQ 275, 277 (CCPA 1968)).
In this case, while Aicardi syndrome may have a different underlying etiology, Aicardi syndrome manifests the same seizures such as focal seizure, infantile spasm or convulsive seizure, which are treatable by pure CBD as evidenced by Vangara. Also, Vangara teaches and suggest the use of pure CBD for treating seizure conditions which are known to be difficult to treat, including Dravet Syndrome and Lennox Gastaut Syndrome, refractory epilepsy, and refractory infantile spasms. Thus, one of ordinary skill in the art would have reasonably expected that the pure CBD of Vangara would be useful for treating the same type of seizures in Aicardi syndrome. There is no evidence that convulsive seizure, focal seizure, or infantile spasm in Aicardi syndrome is different from those in the other intractable seizure conditions such as Dravet Syndrome and Lennox Gastaut Syndrome. Accordingly, similar effective seizure reduction in Aicardi syndrome would have been expected and obvious because Vangara and Porter teach that CBD is useful for treating various types of seizure including refractory epilepsy, juvenile spasms, refractory infantile spasms, and infantile spasms, which are not responsive to conventional anti-epileptic treatment. In addition, the CBD NPL already discloses the use of CBD for treating seizure in patients having Aicardi syndrome while it does not disclose purity of CBD in the compositions used for the therapy. Further, the CBD NPL discloses 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 (see p3, para 1). In view of those teachings, one of ordinary skill in the art would have reasonably expected that the CBD formulation would be useful for treating Aicardi syndrome having seizures similar to the other seizure-related disorders disclosed in Vangara in the absence of evidence to the contrary.
As to Applicant’s assertion that the anonymous CBD NPL is unreliable, even if the anonymous CBD NPL may inadvertently include some incorrect information, it does not change the fact that the use of CBD for treating seizures in a subject having Aicardi syndrome was taught and suggested before the effective filing date. This is further evidenced by NPL reference titled with “Salutaris Drop-Cannabidiol for Aicardi Syndrome” (10/12/2014), which was cited by the IDS filed on 8/10/2021. Also, Vangara already teaches that CBD is useful for treating various types of seizures including refractory epilepsy, infantile spasms, refractory infantile spasms, or infantile spasms and discloses that substantially pure CBD formulations are especially suitable for treatment of epilepsy and discloses anticonvulsive effects on patients with rare seizure disorders such as Dravet syndrome, Lennox Gastaut Syndrome, myoclonic seizure, Juvenile myoclonic seizure, and treatment resistant focal seizure. Thus, one of ordinary skill in the art would have been motivated to use the formulation comprising substantially pure CBD for treating seizure in a patient having Aicardi syndrome on the reasonable expectation that the CBD formulation would be similarly effective for reducing convulsive, focal and refractory (treatment resistant) seizure and infantile spasm in such patient similar to those with the other seizure-related disorders disclosed in Vangara and Porter.
As to the arguments about Porter based on the Whalley declaration, it is noted that it is a copy of the declaration submitted during the prosecution of Application 14/881969, which was allowed. First, it should be noted that each application is examined on its own merit based on the disclosure and the state of art. Also, while Porter is the only reference cited during the prosecution of Application 14/881969, this is not the case here. The Examiner respectfully submits that the above rejection is based on a combination of references, not on Porter taken in a vacuum. As such, Applicants' arguments pertaining to Porter are not persuasive. One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In this case, while Porter may disclose CBD which may include other components besides CBD as Applicant asserted, Vangara already teaches and suggest the use of CBD having the same purity as claimed for the same seizure conditions as Porter. Also, Porter specifically discloses that CBD preparations were tested at commercial medical cannabis testing facilities (p575, col 2, para 1). Also, Porter discloses an additional survey, using the same questions, of parents using stiripentol, a drug that is approved for the treatment of Dravet syndrome in Europe to investigate whether the wording of the questions produced a strong positive bias. However, they found that the results from the stiripentol survey are consistent with published studies on the efficacy and tolerability of stiripentol, thus it is unlikely that the wording of the survey questions was inherently biased. Thus, one of ordinary skill in the art would not have considered the dosing amounts and effects of CBD disclosed in Porter unreliable as Applicant asserted, especially in view of the teachings of Vangara.
As to the arguments regarding Rosser reference, Rosser only states that Aicardi syndrome does not respond well to conventional therapy. However, one of ordinary skill in the art would not consider CBD as a conventional anti-epileptic drug. Instead, one of ordinary skill int eh art would have recognized that Aicardi syndrome is intractable epilepsy not treatable with conventional anti-epileptics similar to those disclosed in Vangara and thus would have been motivated to search for alternative treatments, including CBD.
As to the argument related to FDA approval for treatment of seizures, it should be noted that considerations made by the FDA for approving a treatment are different from those made by the PTO in determining whether the claimed invention is obvious or unobvious. While FDA approval may be considered if, for example, it went to motivation to develop a drug or skepticism regarding drug efficacy, "[t]here is no requirement in patent law that the person of ordinary skill be motivated to develop the claimed invention based on a rationale that forms the basis for FDA approval. Motivation to combine may be found in many places and forms; it cannot be limited to those reasons the FDA sees fit to consider in approving drug applications
As to the CBD dosage, it should be noted that the claimed method encompasses treating seizures, which are symptoms of Aicardi syndrome, not the underlying cause of Aicardi syndrome. Also, Porter teaches that the dosages of cannabidiol ranged from less than 0.5 mg/kg/day to 28.6 mg/kg/day, which overlaps those claimed. While Porter does not teach Aicardi syndrome, Porter discloses the CBD dosing range effective for childhood seizures (epilepsies) similar to Aicardi syndrome. In addition, on the contrary to Applicant’s assertion that the doses of the CBD NPL is far below that claimed, the recommended therapeutic dose in the CBD NPL is 3 mg/kg, 200 mg daily for adults and 50 mg for children. The dose of 200 mg daily is the same as recited in new claim 32. 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.”)
Finally, Applicant argued that the present inventors have surprisingly and unexpected discovered that CBD can treat various seizure types in Aicardi syndrome.
In response, the examiner notes that it is applicant's burden to demonstrate unexpected results over the prior art. See MPEP 716.02, also 716.02 (a) - (g). Furthermore, the unexpected results should be demonstrated with evidence that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance. Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992). Moreover, evidence as to any unexpected benefits must be "clear and convincing" In re Lohr, 137 USPQ 548 (CCPA 1963), and be of a scope reasonably commensurate with the scope of the subject matter claimed, In re Linder, 173 USPQ 356 (CCPA 1972).
In this case, the results would have been expected and obvious because Vangara and Porter teaches that CBD is useful for treating various types of seizure including refractory epilepsy, juvenile spasms, refractory infantile spasms, or infantile spasms. In addition, the CBD NPL already discloses the use of CBD for treating seizure in patients having Aicardi syndrome while it does not disclose purity of CBD in the compositions used for the therapy. In view of those teachings, one of ordinary skill in the art would have reasonably expected that the CBD formulation would be effective for various types of seizures in a subject with Aicardi syndrome similarly to those with the other seizure-related disorders disclosed in Vangara in the absence of evidenced to the contrary.
For the foregoing reasons, Applicant’s arguments have not been found to be persuasive.
Claim 9 is 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), in further view of WO 2012/093255 (hereafter, WHALLEY, cited in the IDS filed on 5/5/2021).
The teachings of Vangara, Porter et al., Rosser et al., and CBD NPL as applied supra are herein applied for the same teachings in their entirety.
They do not teach that the CBD drug substance further comprises up to 1% cannabivarin (CBDV) recited in claim 9 as amended.
WHALLEY teaches the use of cannabidiol (CBD) for treating epilepsy wherein the type of epilepsy to be treated is generalized seizure or temporal lobe seizure, refractory to existing medication (abstract, [0029], and claims 1, 5-6). WHALLEY further teaches the use of CBD with CBDV ([0039] and claim 8).
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 further add a suitable amount of CBDV to the CBD formulation of Vangara because both are taught to be effective for treating seizure and can be used in combination as evidenced by WHALLEY. The skilled artisan would have been motivated to do so for combined effects as suggested by WHALLEY.
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 30-32 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 30-32 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.
Conclusion
No claims are allowed.
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BONG-SOOK BAEK whose telephone number is 571-270-5863. The examiner can normally be reached 9:00AM-6:00PM Monday-Friday.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bethany Barham can be reached on 571-272-6175. The fax phone number for the organization where this application or proceeding is assigned is (571) 273-8300.
Information regarding the status of an application may be obtained from Patent Center. Status information for published applications may be obtained from Patent Center. Status information for unpublished applications is available through Patent Center for authorized users only. Should you have questions about access to Patent Center, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
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) Form at https://www.uspto.gov/patents/uspto-automated- interview-request-air-form.
/BONG-SOOK BAEK/Primary Examiner, Art Unit 1611
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