Detailed Action
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .1
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on Jan 5 2026 has been entered.
Status of Claims
Claims 26, 28, 30-32, 34, 38, 40, 41 are pending and under examination. While claim 38, directed to caprylic/capric triglycerides, is not the subject matter as encompassed by the election of the CBD formulation species LF2 (ethanol free with a sesame oil carrier), it is being examined in the interest of compact prosecution detailed below. Applicant elected formulation LF2 from Table 24 as Group I, encompassed by pending claims 26, 28-37 and 39-41. Noting the examined species LF2 (see paragraph 180).
Information Disclosure Statement
The information disclosure statement(s) (IDS)s submitted on Jan 5 2025 is/are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Terminal Disclaimer
The terminal disclaimer filed on Jan 5 2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of
US Patents 11331279
Application Nos. 15499178, 15166476, 17675805 and 18901666
has been reviewed and is accepted. The terminal disclaimer has been recorded.
Response to Arguments
Applicant’s amendment of Claims 30-31, with respect to their rejection under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph have been fully considered and are persuasive. The claims now recite doses 10 mg/kg or 30 mg/kg of CBD. Support for this amendment can be found at paragraph 189 of the specification reciting doses of “10, 30 and 100 mg/kg.” The rejection of claims 30-31 has been withdrawn.
Applicant's arguments accompanying the Goskonda Rule 132 Declaration, filed Jan 5 2025, have been fully considered but they are not persuasive. Amended claim 26, along with claims 28, 32, 34, 38 and 40-41 are rejected under 35 U.S.C. 103 as being unpatentable over Murty US 583 in view of Whalley US 398 and Stafstrom 2003, as detailed below.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
Claims 26, 28, 32, 34, 38 and 40-41 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2011/0092583 A1 (Murty US 583) in view of US 2013/0296398A1 (Whalley US 398) and Stafstrom and Sasaki-Adams, “NMDA-induced seizures in developing rats cause long-term learning impairment and increased seizure susceptibility,” Epilepsy Res. 53 (2003) 129-137 (Stafstrom 2003).
US 2011/0092583 A1 (Murty) is cited on IDS dated 4/11/2022. US 398 Whalley and Stafstrom 2003 are cited on the PTO-892 form dated 1/27/2025.
Claim 26 is a method for treating infantile spasms in a subject, comprising orally administering to the subject a stable liquid composition comprising
about 10 to about 32% w/w cannabidiol,
about 60 to about 85% w/w caprylic/capric triglycerides; and
an antioxidant;
where said cannabidiol has a purity greater than 98% w/w and is synthetically prepared; and wherein the composition contains less than 0.3% w/w delta-9-tetrahydrocannabinol.
Note similar to elected species CBD formulation LF2, Murty US 583 teaches liquid, ethanol free formulations as detailed in Tables 3 and 4 (starting at paragraph 136).
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Regarding claim 26 and the specific choice of cannabidiol (CBD), active agent, as the cannabinoid compound, Murty US 583 teaches CBD. See claim 6 and paragraph 113.
With regard to claim 26 and prior art analysis, the specification notes a subject in need is one suffering infantile spasms as noted by paragraphs 7, 11 and 111-114. Example 8 of the specification is a study where CBD was administered to rodent (mice and rats) models exposed to maximal electroshock tests (MES) and minimal clonic seizure tests (6 Hz) to evaluate the efficacy of CBD as an anticonvulsant. See Example 8 starting at paragraph 188 to paragraph 192. “As seen in Tables 26 to 29 above, Applicant found that cannabidiol protected the mice and rats from epilepsy.” See paragraph 192.
Example 8 does not disclose treatment of epilepsy/seizures as per infantile seizures. But based on what is generally known by the background art, prior art teaching the core elements of the claimed treatment of epilepsy and seizures with compositions comprising CBD, and noting the common pathophysiology of infantile spasms has with other epileptic and convulsant seizure conditions, will be relevant to a finding of obviousness as detailed below.
Regarding claim 26 and the core elements of a cannabinoid compound, Murty US 583 discloses an oral dosage form of cannabinoids comprising 1-90% wt % of cannabinoid (pharmacologically active) and 15-85% triglyceride carrier (oil based, see the various vegetable oils of claim 8. See paragraph 120 and Table 1 ). See claim 1. As stated above, Murty US 583 teaches CBD as an active agent/ cannabinoid of choice. See claim 6 and paragraph 113. Murty US 583 discloses its cannabinoid formulations further comprise antioxidants, where the antioxidants may vary from about 0.01-15 wt %, preferably from about 0.5 to 12.5 wt %. See paragraph 105.
Regarding claim 26 and treatment of a patient in need, Murty US 583 teaches its compositions of its present invention are useful to improve various lipophilic drugs having poor aqueous solubility such as antiepileptics, i.e., epileptic subjects. See paragraph 114.
While Murty suggests the treatment of the subject in need with epilepsy with its claimed CBD composition, it does not specifically recite the limitation of wherein the composition contains less than 0.3% w/w delta-9-tetrahydrocannabinol (delta9 THC) or the limitation of treating claimed subject suffering from the epileptic condition of infantile spasms.
To address the first deficiency, wherein the composition contains less than 0.3% w/w delta9 THC, while not explicitly recited in Whalley, Whalley US 398 teaches the administration of isolated CBD, which given the plain meaning of isolated, is taken to mean a pure version of CBD. See paragraphs 56, 69, 76 and 89. As a PHOSITA would understand that pure, isolated CBD would be free impurities, it would be routine to optimize such pure, isolated CBD so it contains less than 0.3% w/w delta 9 THC as an impurity.
Regarding the next deficiency, wherein said cannabidiol is prepared synthetically and has a purity greater than 98 w/w, it is noted that the isolated CBD would be the same as the synthetically prepared CBD of claim 26. The fact that one is sourced naturally and later isolated as per Whalley versus synthetically prepared does not change the fact no matter how sourced, CBD is being claimed and taught by the prior art. With regard to the purity limitation of claim 26 of greater than 98%, while not explicitly recited in Whalley, Whalley US Pub 398 teaches the administration of isolated CBD, which, given the plain meaning of isolated, is taken to mean a purified version of CBD. See paragraphs 56, 69, 76 and 89.
To address the next deficiency regarding the claimed subject, similar to the epileptic subject in need of Murty US 583 and the claimed subject suffering from the epileptic condition of infantile spasms, Whalley US 398 teaches a “method for treating epilepsy comprising administering to a subject in need thereof cannabidiol (CBD), at a dose of greater than 300 mg/day, in combination with a standard anti-epileptic drug (SAED) which acts via sodium or calcium channels, for use in the treatment of epilepsy.” See claim 1.2 Whalley US 398 notes the known and accepted epileptic seizure model mouse model used test CBD efficacy was where the epileptic seizures were pentylenetetrazol (PTZ) induced. See paragraph 75.
While both Murty US 583 and Walley US 398 are directed to treatment of epileptic patients with formulations comprising CBD in the claimed concentrations, with the claimed purity of having less than 0.3% w/w delta 9 THC , they do not necessarily recite the epileptic subject in need suffering from infantile spasms as claimed.
To address this deficiency, as Whalley US 398 notes CBD treatment of PTZ induced seizures/epilepsy, Stafstrom 2003 teaches that “[i]nfantile spasms (West syndrome) is an age-specific syndrome of epileptic encephalopathy, beginning in the first year of life, associated with specific seizures (tonic/ myoclonic spasms) and a specific EEG pattern (Dulac, 1997). See page 135, column 1.
Stafstrom 2003 notes its experiments dealt with NMDA induced rats to study seizure activity, where “a characteristic sequence of seizure activity was seen: initial behavioral arrest, followed by hyperactivity, agitation, and then emprosthotonus and generalized tonic-clonic seizures.” See abstract. Stafstrom 2003 teaches that the subject rats were injected with “PTZ . . . to assess their susceptibility to generalized seizures.” See abstract. Latency to PTZ seizure stages included similar scores (stages) as those alluded to in Whalley US 398 above, Stages 4-5, generalized tonic-clonic convulsions with rearing and falling. See page 131, column 2.
Stafstrom 2003 teaches that while seizures in its experiments “[n]evertheless, this [NMDA/ PTZ rat] model is a first step in unraveling the brain’s complex regulation of excitability that might underlie infantile spasms.” See page 135, column 2.
Prior to the filing of the present patent application, it would have been prima facie obvious to a PHOSITA following the teachings of the Murty US 583 and its teaching of a specific CBD composition suggested to treat epilepsy as modified in light of Whalley US 398 to use CBD to treat PTZ induced epilepsy and use purified CBD as claimed, where Stafstrom teaches PTZ induced infantile spasms.
The PHOSITA would have had a reasonable expectation of success because of the obviousness rationale of prior art teachings modified via known methods, where Murty US 583 teaches its CBD composition with excipients, in concentrations claimed, with sufficient purity levels claims as per Whalley, where CBD is known to treat epileptic (PTZ induced) patients, where Stafstrom teaches infantile spasm (induced by PTZ) in a subject are a known form of epileptic seizures to be treated.
With regard to claim 28 claiming refractory infantile spasms, as noted above, Whalley US 398 and Stafstrom 2003 teach the treatment of infantile spasms as claimed. Whalley US 398 teaches treatment of the subject who is refractory to existing medication. See claim 6 and paragraph 48. Therefore, one of ordinary skill in the art would predictably treat an infantile spasms patient who is refractory to other treatments. Additionally, one of ordinary skill in the art would look towards alcohol free CBD formulation as they are known in the art per Murty US 583.
As required by claim 32, dose of 100 mg/kg of CBD, Whalley US 398 emphasizes the treatment of epileptic patients with CBD where it discloses its mouse models were injected with isolated CBD at a dose of 100 mg/kg. See paragraphs 76 and 89.
Regarding claim 34, Murty US 583 discloses liquid, ethanol free formulations as detailed below in Examples 3 and 4 of Tables 3 and 4, starting at paragraph 136.
Claim 38 recites the limitation of caprylic/capric triglycerides, derived from coconut oil. Per claim 38, Murty US Pub 583 teaches surfactants such as caprylic/capric triglycerides PEG-4 esters/PEG-4 complex/PEG-6 esters/PEG-8 esters. See paragraph 54. Further, note per paragraphs 50, 82, 85 etc. and claim 7, Murty US 583 teaches that the one or more triglycerides are sourced form coconut oil.
Per claim 40, Murty US 583 discloses the antioxidant α-tocopherol. See paragraph 55.
Regarding claim 41, Stafstrom 2003 teaches that “[i]nfantile spasms (West syndrome) is an age-specific syndrome of epileptic encephalopathy, beginning in the first year of life, associated with specific seizures (tonic/ myoclonic spasms) and a specific EEG pattern (Dulac, 1997). See page 135, column 1.
Claims 26, 28, 30, 31, 32, 34, 38 and 40-41 are rejected under 35 U.S.C. 103 as being unpatentable over US 20110092583 A1 (Murty US 583) in view of US 20130296398A1 (Whalley US 398) and Stafstrom and Sasaki-Adams, “NMDA-induced seizures in developing rats cause long-term learning impairment and increased seizure susceptibility,” Epilepsy Res. 53 (2003) 129-137 (Stafstrom 2003), as applied to claims 26, 28 and 32-41, in further view of von Wrede et al. “Cannabidiol in the Treatment of Epilepsy,” Clin. Drug Invest. (2021) 41:211–220. US 20110092583 A1 (Murty) is cited on IDS and prosecution of parent application 14724351. US 398 Whalley, Stafstrom 2003 and von Wrede are cited on the PTO-892 form.
As discussed above, as per Murty, Whalley and Stafstrom, in rejecting claims 26, 28, 32, 34 38 and 40-41, the rationale to support the obviousness rejection is the combination of known elements (association of epilepsy and infantile spasms with tonic-clonic seizures in PTZ rodent models) using known methods of administering CBD in known doses to produce predictable results as claimed and supported by the specification.
It is noted that Murty, Whalley and Stafstrom 2003 do not teach the values of claims 30-31 (about 10 mg or 30 mg (respectively) of CBD per kg of subject).
As required by the dose limitations of claims 30-31, von Wrede teach a “double-blind, placebo-controlled trial of CBD in DS [Dravet syndrome, severe myoclonic epilepsy of infancy] (GWCARE1b) was carried out in 120 children and adolescents using 20 mg/kg/day of CBD.” See page 212, column 2. It is also noted that Whalley US 398 teaches dose adjustment at 100 mg/kg, see paragraph 75 and notes dose adjustments of 50 mg mg/kg, see paragraph 89.
While von Wrede is directed to pediatric subject with Dravet syndrome and the claimed pediatric subject suffers from infantile spasms, one of ordinary skill in the art would routinely optimize3 the dose as the general conditions of the rejected claims are disclosed in the prior art (epileptic pediatric DS subjects with a dose taught in the prior art). Note that Murty US 583 also discloses that “those having ordinary skill in the art will understand that changes can be made to the specific embodiments without departing from the spirit and scope of the invention.” See paragraph 248, Accordingly, it would be within the skill levels of a PHOSITA to make dose adjustments deemed necessary to optimize dosing of CBD to treat infantile spasms as presently claimed.
A PHOSITA would routinely optimize dosing in a pediatric subject with the epileptic seizure disorder, Dravet syndrome, to treat another pediatric epileptic seizure disorder, infantile spasms.
RESPONSE TO ATTORNEY ARGUMENTS:
The Attorney notes claim 26 has been amended to recite limitations of canceled claim 35, so that the CBD in the composition is “synthetically prepared” and “has a purity greater than 98 %.” The Attorney states that the rejections are not new grounds of rejection and the Examiner is requested to now consider them and accompanying Attorney response, citing to the newly submitted Rule 132 Declaration of Venkat Goskonda (Goskonda Declaration), a named inventor on this Application. As requested, the Declaration and Attorney are addressed below.
The Attorney response states (Murtv US 583provides no reason to choose CBD from among the list of cannabinoids listed on claim 6 and paragraph 113, in the Examples of Murty, the formulations are all THC formulations, including Example 15, a marijuana extract. See Goskonda Declaration paragraph 11.
In response, Murty US 583 teaches CBD, among other cannabinoids, is a first preferred embodiment of an oral dosage form. See paragraph 49. The selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination. See, Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327 (1945) and MPEP § 2144.07. It is further noted that an express suggestion to substitute one equivalent component or process for another is not necessary to render such substitution obvious. See In re Fout, 675 F.2d 297 (CCPA 1982) and MPEP § 2144.06(II).
While Murty discloses THC as well as other cannabinoid alternatives, “the prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed….” In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004).
The Attorney response states that a solvent and excipient combination suitable for formulating THC as described in Murty US 583 may not be suitable for formulating CBD as a stable liquid, citing to the Goskonda Declaration ¶11.
The Attorney response states because of the structural (cyclic vs bicyclic), chemical and physical differences (viscous honey like gel vs. crystalline powder) between THC and CBD (unique degradation pathways also, delta8-THC vs. delta 9 THC, delta 6CBD and quinones), a PHOSITA would not assume/predicted THC formulation systems would provide a system a stable liquid formulation for CBD. (Goskonda Declaration ¶¶ 12-24).
In response, while Applicant and the Goskonda Declaration note chemical and physical differences between Delta 9 THC and CBD (cyclic/bicyclic, viscous gel/powder, different degradation pathways), as detailed above, Murty US 583 teaches CBD, among other cannabinoids, is a first preferred embodiment of its oral dosage form. See paragraph 49. Note MPEP § 2144.07 and Sinclair & Carroll Co. v. Interchemical 325 U.S. 327 (1945), and In re Fulton regarding the prior art’s mere disclosure of more than alternative is a not teaching away because the disclosure does not criticize, discredit or otherwise discourage the solution claimed. In fact, Murty US 583 teaches CBD, along with delta9 THC. Further Murty US 583 teaches its formulations (see paragraphs 49, 113 and claim 6), which also expand the physical variety of delta 9 THC (viscous gel) and CBD (crystalline dry powder), thus proving guidance of alternatives for a PHOSITA to substitute THC and CBD for the Murty pharmaceutical formulations. Murty paragraphs 49, 113 and claim 6 disclose cannabinol (CBN)/multicyclic known to typically exist as a crystalline powder4, as well as cannabidivarin (CBDV) a monocyclic compound5, supplied as a crystalline powder; as well as delta 8 THC, a multicyclic compound. Thus, the teachings of Murty US 583 disclose the use of various cannabinoid compounds with varying physical and chemical differences to be formulated in its pharmaceutical compositions.
The Attorney response states as per the Goskonda Declaration ¶5, Dr. Goskonda began to investigate synthetically prepared CBD pharmaceutical formulations to overcome naturally sourced/commercially available CBD available as hemp extracts with other cannabinoids (THC) as impurities. It is alleged that synthetic CBD are stable improvements over prior art formulations. See specification at paragraphs 6 and 8. The Attorney response states Murtv US 583 does not teach "purity greater than 98% w/w" and "synthetically prepared" and "less than 0.3% w/w delta-9-tetrahydrocannabinol" limitations.
In response, allegations of unexpected results submitted via Declaration evidence, require that the results be unexpected (MPEP 716.02(a)) and within the scope of the claimed invention (MPEP 716.02(d)).
With regard to whether the synthetic CBD is unexpected and whether such a composition has the claimed purity level with regard to delta9 THC, while not explicitly recited in Whalley, Whalley US 398 teaches the administration of isolated CBD, which given the plain meaning of isolated, is taken to mean a pure version of CBD. See paragraphs 56, 69, 76 and 89. As a PHOSITA would understand that pure, isolated CBD would be free impurities, it would be routine to optimize such pure, isolated CBD so it contains less than 0.3% w/w delta 9 THC as an impurity. Wherein said cannabidiol is prepared synthetically and has a purity greater than 98 w/w, it is noted that the isolated CBD would be the same as the synthetically prepared CBD of claim 26. The fact that one is sourced naturally and later isolated as per Whalley versus synthetically prepared does not change the fact no matter how sourced, CBD is being claimed and taught by the prior art. With regard to the purity limitation of claim 26 of greater than 98%, while not explicitly recited in Whalley, Whalley US Pub 398 teaches the administration of isolated CBD, which, given the plain meaning of isolated, is taken to mean a purified version of CBD. See paragraphs 56, 69, 76 and 89.
With regard to the scope of the examined claims being commensurate in scope (MPEP 716.02(d) with any unexpected results, initially the Examiner requests clarification as to what result is achieved with the alleged unexpectedness of synthetic CBD with regard to treating infantile spasms in terms of testing resulting in unexpected results as per the claimed method, where evidence of unexpected and expected properties must be weighed (MPEP 716.02(c)). Evidence of an experimental comparison of naturally extracted CBD with the pure isolated form as per Whalley in comparison to the synthetic pure CBD of the claimed invention with unexpected results would overcome the prima facie case. It is noted per the Goskonda Declaration Examples 1-7 are referenced with general allegations of improved shelf life, but the argument could be made such results would be expected, since purity of the CBD is expected in the prior art as detailed above. Also note, the specification or prosecution does not detail a comparative test to support a finding of nonobviousness. See MPEP 716.02(B)(III.).
Lastly, the question remains as to whether the unexpected results are commensurate in scope with the claimed invention (MPEP 716.02(d)).
Note that the claimed invention broadly claims a scope of (claim 26)
a stable liquid composition comprising
about 10 to about 32% w/w cannabidiol,
about 60 to about 85% w/w caprylic/capric triglycerides and
an antioxidant.
Accordingly, the scope is noted to include the claimed composition of 10% cannabidiol, about 60% caprylic/capric triglycerides and an antioxidant. In this particular embodiment, as allowed by the “comprising” term, 30% of the composition is open to be any component, including degradants such as delta9 THC, or other cannabinoid compounds, such naturally sourced CBD.
The Goskonda Declaration relies upon example formulations LF1-LF7, particularly LF7 (see Goskonda Declaration ¶9), for its support of unexpected results. Examples LF1-7 are far narrower in scope to pending claim 26 which can contain up to 30% impurities as noted above.
Even if the Examiner were convinced that formulations LF1-7 were representative of unexpected results, the presently claimed method is far broader than the working examples said to support such unexpected results.
The Attorney response requests the withdrawal of the dependent claims 28, 30, 31, 32, 34-35, and 40-41 for the reasons discussed above for independent claim 26.
As the Examiner has addressed the Attorney arguments with regard to claim 26, the dependent claims remain rejected as detailed above.
Conclusion and Correspondence
In summary, no claims are allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM LEE whose telephone number is (571)270-3876. The examiner can normally be reached M-F.
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, Adam C. Milligan can be reached at (571) 270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/WILLIAM Y LEE/
Examiner, Art Unit 1623
/ADAM C MILLIGAN/Supervisory Patent Examiner, Art Unit 1623
1 This application is a DIV of 14/724,351, filed on 05/28/2015, issued as PAT US 11224660. App. Nos. 14/724,351 claims priority to 62/154,660 filed 04/29/2015; and 62/004,495 filed 05/29/2014.
2 In fact with regard to dose, Whalley US 398 emphasizes the treatment of epileptic patients with CBD where it discloses its mouse models were injected with isolated CBD at a dose of 100 mg/kg. See paragraph 76. See also paragraph 89 noting doses of 50, 100 and 200g mg/kg of CBD. Whalley US 398 notes the known and accepted epileptic seizure model mouse model used test CBD efficacy was where the epileptic seizures were pentylenetetrazol (PTZ) induced. See paragraph 75. Further Whalley US 398 notes that markers for efficacy of epilepsy and seizure treatment with CBD are measured in terms of expression of tonic-clonic seizure with suppressed tonic phase or fully developed tonic-clonic seizure. See Table 1.1 of paragraph 77. Whalley US 398 demonstrates that per FIG 1 that CBD in combination with anti-seizure medicines reduced mortality and the incidence of tonic-clonic seizures. See paragraph 84.
3 MPEP 2144.05 II. A. Optimization Within Prior Art Conditions or Through Routine Experimentation
“[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
4 https://www.extractlabs.com/product/bulk-cbd-isolate/
5 https://www.crescolabs.com/cannabinoids/cbdv/
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