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 .
Status of the Claims
Per Applicant’s amendment to the claims, submitted on 10/13/2025, claims 33-34 and 39-53 are amended, and claims 37-38 are canceled. Currently, claims 33-36 and 39-53 are pending in the instant application.
Objections to Specification - Maintained
Objection to Specification:
Applicant’s amendment to the specification is not sufficient to overcome the objection. Accordingly, the objection is maintained. Applicant has amended the specification as follows:
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However, the remaining web address still falls within the realm of browser executable code.
Claim Rejections - 35 USC § 102 – Withdrawn
Rejections of claims 33 and 36-37:
In light of Applicant’s amendment to the claims, the rejections are hereby withdrawn. Claim 33 now recites zolmitriptan rather than generic triptans, and is no longer anticipated by Novotny which teaches administration of sumatriptan. However, new rejections are necessitated by amendment and will be detailed herein.
Claim Rejections - 35 USC § 103 – Withdrawn
Rejections of claims 34-35, 38-53:
In light of Applicant’s amendment to the claims, the rejections are hereby withdrawn. The rejections of the claims were predicated on the 102 rejection of claim 33 over Novotny. As the amendment to claim 33 overcomes the 102 rejection, the 103 rejections are also overcome. However, new rejections are necessitated by amendment and will be detailed herein.
Claim Rejections - 35 USC § 103 – Necessitated by Amendment
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.
Claim(s) 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Baraban (US 20180028499 A1) in view of Blankenship (Ped Health. 2010 September 29; 4(4): 375–381), Visser (previously referenced), and Sato (International Journal of Neuropsychopharmacology (2007), 10, 281–283).
Claim 33 recites a method of treating irritability or sociability symptoms associated with ASD comprising administering a therapeutically effective amount of zolmitriptan or a pharmaceutically acceptable salt thereof, to a patient in need thereof.
Baraban teaches the administration of 5HT receptor agonists for the treatment of epilepsy disorders (claim 1)1. In particular, wherein the 5HT receptor agonist may be zolmitriptan (claim 11)2, and wherein the subject suffering from the epilepsy disorder has autism (claim 21)3. Essentially, Baraban teaches the administration of zolmitriptan to subjects suffering from autism. Baraban does not explicitly teach the treatment of irritability or sociability symptoms of autism. However, it would be obvious to treat such symptoms using zolmitriptan because Blankenship teaches the use of the 5HT receptor agonist aripiprazole to treat irritability symptoms of autism, and
Blankenship teaches the administration of 5HT receptor agonist aripiprazole for the treatment of irritability associated with autism. Blankenship indicates that aripiprazole is a partial agonist at the D2, D3, and 5-HT1A receptors, and exhibits high affinity for D2, D3, 5-HT1A and 5-HT2A receptors (page 2)4. Furthermore, Blankenship indicates that aripiprazole was effective in significantly improving irritability in autistic adolescent subjects in double blind studies. More specifically, that administration of aripiprazole at 5, 10, 0r 15 mg daily to autistic children aged 6-17 over an 8 week period showed greater improvement over placebo when assessed by the Aberrant Behavior Checklist Irritability subscale (ABC-I) and the Clinical Global Impressions-Improvement scale (CGI-I) (page 3)5.
Visser teaches compound 311C90 (zolmitriptan) as being a selective and potent 5HT1d receptor agonist with moderate affinity for 5HT1A receptors (page 522)6. While the teachings of Visser are generally directed towards the use of zolmitriptan for use in treatment of migraine, Visser provides valuable information with regards to the receptor affinity of zolmitriptan. Together with the teachings of Blankenship, this reveals that both zolmitriptan and aripiprazole at least share in common affinity for the 5HT1A receptor.
Sato teaches the use of tandospirone, a partial 5HT1A receptor agonist, for the treatment of behavioral and psychological symptoms of dementia (BPSD). Sato discloses a study conducted over eight weeks wherein patients suffering from BPSD were provided daily doses of tandospirone citrate, providing the results below (page 282 Table 1):
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As can be seen from the table, irritability as assessed by NPI scores saw significant decreases at each of the 2, 4, 6, and 8 week time points throughout the study. While the teachings of Sato are drawn to the use of tandospirone rather than zolmitriptan, and the treatment of BPSD irritability or sociability symptoms of autism, said teachings are useful in that they indicate 5HT1A agonism as a mechanism for treating irritability.
In summary, Baraban teaches the administration of 5HT1 receptor agonists such as zolmitriptan to patients suffering from autism, Blankenship teaches aripiprazole is a moderate agonist of 5HT1A and is useful in treating irritability symptoms in autistic adolescents, Visser teaches that zolmitriptan has moderate affinity for the 5HT1A receptor, and Sato teaches that partial 5HT1A agonism is useful for the treatment of irritability symptoms. It would have been prima facie obvious at the time of invention for a person of ordinary skill in the art to arrive at the method of the instant claims by combining the teachings of each of Baraban, Blankenship, Visser, and Sato to treat irritability or sociability symptoms associated with autism spectrum disorder.
Claim 34 further limits the method of claim 33 wherein prior to said treatment, the patient is diagnosed with ASD using the DSM 5 diagnostic criteria.
As discussed in the 103 rejection of claim 33, the combined teachings obviate a method of treating irritability or sociability symptoms associated with ASD by administering zolmitriptan to a patient in need thereof. The previously indicated prior art do not explicitly teach the use of a diagnoses using the DSM 5 diagnostic criteria; however the use of such criteria would be obvious because it is generally well known in the art that the DSM is an industry-wide diagnostic standard for classifying mental disorders. As the teachings of Baraban and Blankenship are explicitly drawn to patients suffering from autism, it would be obvious to identify such patients as having the target condition by using the most recent version of the DSM (i.e., DSM5), prior to administration.
Claim 35 further limits the method of claim 33 wherein the patient is an adolescent or a child.
The teachings of Blankenship indicate administration to adolescents aged 6-17.
Claim 36 further limits the method of claim 22 wherein the patient is an adult.
Baraban indicates administration of zolmitriptan to adults (specification [0119])7. Furthermore, the teachings of Sato appear to indicate that the effects of 5HT1A agonism on irritability are apparent in adult patients, as all patients taking part in the study were adults.
Claim 39 further limits the method of claim 33 wherein about 1 mg to about 50 mg of zolmitriptan is administered to the patient.
Visser conducts safety and efficacy testing on a compound of 311C90 (zolmitriptan). Zolmitriptan was found to be well tolerated at doses of 1, 5, and 25 mg doses.
Claim 40 further limits the method of claim 39 wherein the zolmitriptan is administered once per day.
In the study conducted by Visser, patients were dosed once with zolmitriptan, and offered an optional second dose. Due to the second dose being voluntary, the full dosing cohort of Visser comprises patients who were dosed once and patients who were dosed twice. As the dosing cohort comprises patients who were only dosed once in a 24 hour period, the instant claim is obviated by the teachings of Visser.
Claim 41 further limits the method of claim 38 wherein the administration provides a CSF level of about 0.05 ng/ml to about 2 ng/ml.
Looking towards Applicant’s provided disclosure, table 4 is provided as guidance with regards to doses needed to achieve targeted levels of zolmitriptan in CSF (specification [0220]):
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The above table indicates that a human dose of zolmitriptan between 1.25-35 mg is sufficient to achieve a target range of 0.078-1.24 ng/ml zolmitriptan in CSF. As previously discussed, Visser teaches the dosing of zolmitriptan at 1, 5, and 25 mg. At least two of the doses taught by Visser fall squarely within the amount needed to reach a zolmitriptan CSF level within the recited range. Accordingly, the instant claim is rejected for the same obviousness reasons as claim 33.
Claim 42 further limits the method of claim 33, wherein the administration reduces the patient's Aberrant Behavior Checklist 2-Irritability (ABC-I) Subscale Score by at least 2 points compared to prior to said administration.
The instant claim describes a result effective variable in the form of ABC-I subscale score. Per the provided disclosure, the Aberrant Behavior Checklist (ABC) is an assessment system utilized to rate symptoms of behavioral impairment (specification [0155])8. The disclosure further indicates that reduction of symptoms is characterized by at least a one point reduction in ABC-I score (specification [0156])9. In other words, the therapeutically effective amount of triptan compound as recited in parent claim 33 must be sufficient to lower the ABC-I rating by at least 2 points. Guidance provided by Applicant’s specification in regards to human doses of zolmitriptan exists in table 4 (specification [0220]):
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The provided table is indicative of the amount of zolmitriptan in a human dose required to produce an effective concentration of zolmitriptan in CSF based on EC50 values. As this appears to be the only guidance in the specification on effective doses of zolmitriptan in humans, it would be assumed that such doses would be effective to provide the recited 2 point reduction in ABC-I irritability subscore. As previously discussed, Visser teaches the dosing of zolmitriptan at 1, 5, and 25 mg. At least two of the doses taught by Visser fall squarely within the amount needed to reach a zolmitriptan CSF level within the recited range. Accordingly, the instant claim is rejected for the same obviousness reasons as claim 33.
Claim 43 further limits the method of claim 33 wherein the administration reduces the patient's ABC- Lethargy Social Withdrawal (ABC-LSW) Subscale Score by at least two points compared to prior to said administration.
Similarly to claim 42 the instant claim recites a result effective variable in the form of reduction in ABC-LSW score. Such a reduction would be based upon what is considered as an “effective” dose of a triptan compound. Table 4 of Applicant’s specification provides guidance on what is considered an effective dose of zolmitriptan, and such doses are obviated by the combination of the aforementioned teachings because Visser teaches zolmitriptan dosing amounts which lie within the “effective” amounts as described by the specification as it is informing to the limitations of the instant claim. So long as the dosing amounts taught by Visser lie within such ranges, the limitations of the instant claim with regards to score reduction should also be met.
Claim 44 further limits the method of claim 33 wherein the administration reduces the patient's autism behavior inventory (ABI) score by at least one point compared to prior to said administration.
Similarly to claim 42 the instant claim recites a result effective variable in the form of reduction in ABI score. Such a reduction would be based upon what is considered as an “effective” dose of a triptan compound. Table 4 of Applicant’s specification provides guidance on what is considered an effective dose of zolmitriptan, and such doses are obviated by the combination of the aforementioned teachings because Visser teaches zolmitriptan dosing amounts which lie within the “effective” amounts as described by the specification as it is informing to the limitations of the instant claim. So long as the dosing amounts taught by Visser lie within such ranges, the limitations of the instant claim with regards to score reduction should also be met.
Claim 45 further limits the method of claim 33 wherein the administration reduces the patient's ABI Repetitive/Restrictive Behavior Domain Score by at least one point compared to prior to said administration.
Similarly to claim 42 the instant claim recites a result effective variable in the form of reduction in ABI Repetitive/Restrictive Behavior Domain score. Such a reduction would be based upon what is considered as an “effective” dose of a triptan compound. Table 4 of Applicant’s specification provides guidance on what is considered an effective dose of zolmitriptan, and such doses are obviated by the combination of the aforementioned teachings because Visser teaches zolmitriptan dosing amounts which lie within the “effective” amounts as described by the specification as it is informing to the limitations of the instant claim. So long as the dosing amounts taught by Visser lie within such ranges, the limitations of the instant claim with regards to score reduction should also be met.
Claim 46 further limits the method of claim 33 wherein the administration reduces the patient's ABI Mood and Anxiety Domain Score by at least one point compared to prior to said administration.
Similarly to claim 42 the instant claim recites a result effective variable in the form of reduction in ABI Mood and Anxiety Domain score. Such a reduction would be based upon what is considered as an “effective” dose of a triptan compound. Table 4 of Applicant’s specification provides guidance on what is considered an effective dose of zolmitriptan, and such doses are obviated by the combination of the aforementioned teachings because Visser teaches zolmitriptan dosing amounts which lie within the “effective” amounts as described by the specification as it is informing to the limitations of the instant claim. So long as the dosing amounts taught by Visser lie within such ranges, the limitations of the instant claim with regards to score reduction should also be met.
Claim 47 further limits the method of claim 33 wherein the administration reduces the patient's ABI Challenging Behavior Domain Score by at least one point compared to prior to said administration.
Similarly to claim 42 the instant claim recites a result effective variable in the form of reduction in ABI Challenging Behavior Domain score. Such a reduction would be based upon what is considered as an “effective” dose of a triptan compound. Table 4 of Applicant’s specification provides guidance on what is considered an effective dose of zolmitriptan, and such doses are obviated by the combination of the aforementioned teachings because Visser teaches zolmitriptan dosing amounts which lie within the “effective” amounts as described by the specification as it is informing to the limitations of the instant claim. So long as the dosing amounts taught by Visser lie within such ranges, the limitations of the instant claim with regards to score reduction should also be met.
Claim 48 further limits the method of claim 33 wherein the administration reduces the patient's ABI Self-regulation Domain Score by at least one point compared to prior to said administration.
Similarly to claim 42 the instant claim recites a result effective variable in the form of reduction in ABI Self-regulation Domain score. Such a reduction would be based upon what is considered as an “effective” dose of a triptan compound. Table 4 of Applicant’s specification provides guidance on what is considered an effective dose of zolmitriptan, and such doses are obviated by the combination of the aforementioned teachings because Visser teaches zolmitriptan dosing amounts which lie within the “effective” amounts as described by the specification as it is informing to the limitations of the instant claim. So long as the dosing amounts taught by Visser lie within such ranges, the limitations of the instant claim with regards to score reduction should also be met.
Claim 49 further limits the method of claim 33 wherein the administration reduces the patient's ABI- Short Form (ABI-S) Score by at least one point compared to prior to said administration.
Similarly to claim 42 the instant claim recites a result effective variable in the form of reduction in ABI-S score. Such a reduction would be based upon what is considered as an “effective” dose of a triptan compound. Table 4 of Applicant’s specification provides guidance on what is considered an effective dose of zolmitriptan, and such doses are obviated by the combination of the aforementioned teachings because Visser teaches zolmitriptan dosing amounts which lie within the “effective” amounts as described by the specification as it is informing to the limitations of the instant claim. So long as the dosing amounts taught by Visser lie within such ranges, the limitations of the instant claim with regards to score reduction should also be met.
Claim 50 further limits the method of claim 33 wherein the administration reduces the patient's clinical global impression of improvement scale (CGI-I) score by at least one point compared to prior to said administration.
Similarly to claim 42 the instant claim recites a result effective variable in the form of reduction in CGI-I score. Such a reduction would be based upon what is considered as an “effective” dose of a triptan compound. Table 4 of Applicant’s specification provides guidance on what is considered an effective dose of zolmitriptan, and such doses are obviated by the combination of the aforementioned teachings because Visser teaches zolmitriptan dosing amounts which lie within the “effective” amounts as described by the specification as it is informing to the limitations of the instant claim. So long as the dosing amounts taught by Visser lie within such ranges, the limitations of the instant claim with regards to score reduction should also be met.
Claim 51 further limits the method of claim 33 wherein the administration reduces the patient's Clinician Global Impression of Severity (CGI-S) Score by at least one point compared to prior to said administration.
Similarly to claim 42 the instant claim recites a result effective variable in the form of reduction in CGI-S score. Such a reduction would be based upon what is considered as an “effective” dose of a triptan compound. Table 4 of Applicant’s specification provides guidance on what is considered an effective dose of zolmitriptan, and such doses are obviated by the combination of the aforementioned teachings because Visser teaches zolmitriptan dosing amounts which lie within the “effective” amounts as described by the specification as it is informing to the limitations of the instant claim. So long as the dosing amounts taught by Visser lie within such ranges, the limitations of the instant claim with regards to score reduction should also be met.
Claim 52 further limits the method of claim 33 wherein the administration reduces the patient's Social Responsiveness Scale 2 (SRS-2) score by at least 5% compared to prior to said administration.
Similarly to claim 42 the instant claim recites a result effective variable in the form of reduction in SRS-2 score. Such a reduction would be based upon what is considered as an “effective” dose of a triptan compound. Table 4 of Applicant’s specification provides guidance on what is considered an effective dose of zolmitriptan, and such doses are obviated by the combination of the aforementioned teachings because Visser teaches zolmitriptan dosing amounts which lie within the “effective” amounts as described by the specification as it is informing to the limitations of the instant claim. So long as the dosing amounts taught by Visser lie within such ranges, the limitations of the instant claim with regards to score reduction should also be met.
Claim 53 further limits the method of claim 33 wherein the administration reduces the patient's Vineland-3 (Domain Level Version) Score by at least one point compared to prior to said administration.
Similarly to claim 42 the instant claim recites a result effective variable in the form of reduction in Vineland-3 score. Such a reduction would be based upon what is considered as an “effective” dose of a triptan compound. Table 4 of Applicant’s specification provides guidance on what is considered an effective dose of zolmitriptan, and such doses are obviated by the combination of the aforementioned teachings because Visser teaches zolmitriptan dosing amounts which lie within the “effective” amounts as described by the specification as it is informing to the limitations of the instant claim. So long as the dosing amounts taught by Visser lie within such ranges, the limitations of the instant claim with regards to score reduction should also be met.
Double Patenting – Maintained
Claims 33-36 and 39-53 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7, 10, 13-15, 19, 22-27, 29-31, 33, 35, 53, and 57 of copending Application No. 18/552,420 (reference application, herein the ‘420 application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims at hand are exceedingly similar and are drawn to overlapping in subject matter.
Rejections of claims 33-36 and 39-53:
Applicant has expressed intent to hold the rejections in abeyance until the claims are otherwise indicated for allowance. Accordingly, the Double Patenting rejections will be maintained. For the purpose of clarity and record, the outstanding rejections will be reiterated below
Reiterated rejections:
Claim 33 of the instant application recites method of treating the symptoms associated with autism spectrum disorder (ASD) comprising administering a therapeutically effective amount of a triptan, or a pharmaceutically acceptable salt thereof, to a patient in need thereof.
Claim 37 of the instant application recites the method of claim 33 wherein the triptan is sumatriptan, zolmitriptan, naratriptan, rizatriptan, almotriptan, frovatriptan, eletriptan, donitriptan or avitriptan, or a pharmaceutically acceptable salt thereof.
Claim 38 of the instant application recites the method of claim 37 wherein the triptan is zolmitriptan or a pharmaceutically acceptable salt thereof.
Claim 1 of the ‘420 application recites an oral composition for treating the symptoms of autism spectrum disorder, wherein the composition comprises from about 7.5 mg to about 90 mg of zolmitriptan, or a pharmaceutical acceptable salt thereof, and the oral administration of the composition provides a therapeutically effective plasma concentration of zolmitriptan for a period of about 8 hours to about 24 hours.
Claim 33 of the ‘420 application recites an oral composition of zolmitriptan, or a pharmaceutically acceptable salt thereof for treating the symptoms of autism spectrum disorder providing a modified release profile, wherein the composition when dissolution tested using United States Pharmacopoeia Apparatus II (paddles @ 50 rpm) in 900 mL of 0.1N HCl at 370C exhibits a zolmitriptan release profile substantially corresponding to the following pattern: from about 20%-40% of the total zolmitriptan is released after about 15 minutes; after 4 h about 40%-75% of the total zolmitriptan is released; and after 8 h about 75%-90% of the total zolmitriptan is released.
Claim 53 of the ‘420 application recites a composition for treating the symptoms of autism spectrum disorder, wherein the composition comprises zolmitriptan, or a pharmaceutically acceptable salt thereof, wherein the oral administration of the composition provides an AUC0-24h of about 40 ng-h/mL to about 300 ng-h/mL to treat the symptoms of autism spectrum disorder.
Claim 57 of the ‘420 application recites a method of treating the symptoms of autism spectrum disorder, comprising orally administering a pharmaceutical composition of a composition of claim 1to a patient in need thereof.
As can be seen from the exemplified claims above, the invention of the instant application is drawn to a method of treating symptoms of ASD by administering triptans, and more specifically wherein the triptan is zolmitriptan. The invention of the ‘420 application is drawn to compositions of zolmitriptan and a methods of use of said compositions in treating symptoms of ASD by administration. Both the instant application and the reference application are overlapping and are drawn to essentially the same subject matter, that is, the treatment of ASD symptoms by administering zolmitriptan. Given the exceeding similarities of the both applications, the claims at hand cannot be considered as patentably distinct from one another.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 33-36 and 39-53 are rejected.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/ERIC TRAN/Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629
1 “1. A method of treating an epilepsy disorder, said method comprising administering to a subject in need thereof a therapeutically effective amount of a 5HT receptor agonist, or a pharmaceutically acceptable salt thereof.”
2 “The method of claim 1, wherein said 5HT receptor agonist is sumatriptan, naratriptap, rizatriptan, zolmitriptan, urapidil, BRL-54443 (3-(1-methylpiperidin-4-yl)-1H-indol-5-ol),lorcaserin, buspirone, ziprasidone, TCB-2 ((4-Bromo-3,6-dimethoxybenzocyclobuten-1-yl)methylamine hydrobromide), BRL-15572 (3-(4-(4-chlorophenyl)piperazin-1-yl)-1,1-diphenyl-2-propanol), trazodone, BMY 7378 (8-(2-[4-(2-methoxyphenyl)-1-piperazinyl]ethyl)-8-azaspiro[4.5]decane-7,9-dione), atomoxetine, or venlafaxine.”
3 “The method of claim 1, wherein said 5HT receptor agonist inhibits compulsive behaviors or electrographic seizures in an epilepsy subject, an Alzheimer's disease subject, an autism subject, or a Parkinson's disease subject.”
4 “Aripiprazole is a partial agonist at the D2 (dopamine), D3 and 5-HT1A (serotonin) receptors. It also functions as an antagonist at the 5-HT2A receptor. It exhibits high affinity for D2, D3, 5-HT1A and 5-HT2A receptors. Aripiprazole possesses moderate affinity for D4, 5-HT2C, 5- HT7, α1 adrenergic and H1 histaminic receptors. Aripiprazole does not have significant affinity for muscarinic receptors”
5 “The subjects in this study were randomized to receive aripiprazole 5, 10 or 15 mg per day or placebo for 8 weeks. All groups receiving aripiprazole demonstrated significantly greater improvement compared with placebo at week 8 as judged by the Aberrant Behavior Checklist Irritability subscale (ABC-I; primary end point) [11] and the Clinical Global Impressions-Improvement scale (CGI-I)”
6 “311C90 is a new, selective, and potent 5-HT receptor agonist.13 In vitro, the drug displays high affinity at human recombinant 5-HT receptors, modest affinity for 5-HT receptors, and lacks significant affinity for other 5-HT receptors and a wide variety of monoamine receptors.”
7 “The epilepsy disorder may be an epilepsy disorder which is non-responsive to treatment with an antiepileptic drug (AED). The subject may eat a ketogenic diet. The epilepsy disorder may be an epilepsy disorder in an adult (e.g. more than about 16 years old).”
8 “The aberrant behavior checklist (ABC) is a behavior rating scale that is utilized to rate individuals in five subscales:(1) irritability, agitation, and crying, (2) lethargy, social withdrawal, (3)stereotypic behavior, (4) hyperactivity and noncompliance, and (5) inappropriate speech. Individuals can be evaluated on the ABC by any adult that knows the individual well. The ABC contains a 58-item questionnaire that is utilized to assess the five-subscales. Each item on the 58-item questionnaire is rated from 0 to 3. A score of 0 means an absence in symptom. A score of 3 means an individual experiences the symptom with high severity.”
9 “