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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 Oct 31 2025 has been entered.
Status of Claims
Claims 26, 31-32, 35, 39, 43 and 78-84 are pending and under examination. Applicant’s elected species of generalized tonic clonic seizures Formulation #LFlO is a liquid and contains 31.09% pure cannabidiol, 0.2 % vitamin E antioxidant, 68.785 % caprylic/capric triglyceride, flavoring and sweetener, and is one of many of Applicant's #LF formulations in Tables 25 and 26 are encompassed by the examined claims.
Response to Arguments
Applicant’s amendment of claim 43, filed Oct 31 2025, with respect to the objection of claim 43, missing period has been added, has rendered the rejection moot and its rejection withdrawn.
Applicant’s arguments, filed Oct 31 2025, with respect to the rejection of claim(s) 26, 31-32, 35, 39, 43, and 78-84 under 35 U.S.C. 103 as being unpatentable over US 20110306660A1 (US Pub 660) in view of Buck PharmD, Contributing Editor: A Guide to Pharmaceutical Excipients," Pediatric Pharmacotherapy, Newsletter Children’s Medical Center at the University of Virginia Volume 2 Number 9 September 1996 (Pediatric Pharmacotherapy 1996) and U.S. 2013/0296398 A1 (Whalley US Pub 398) but they are not persuasive. See below rejection and response to Attorney response.
Claim Interpretation
Claim 26 is directed towards a method of reducing seizure frequency in a pediatric subject with refractory epilepsy, comprising orally administering to the subject an alcohol-free composition consisting essentially of
20% to 35% w/w cannabidiol having a purity of greater than 98% w/w;
5% to 30% w/w polyethylene glycol;
5% to 35% w/w propylene glycol; and
4% to 8% w/w water;
wherein the composition contains less than 0.3% w/w delta-9-tetrahydrocannabinol.
Previously, the Examiner treated the transitional phrase “consisting essentially of” to be equivalent to “comprising of” due to potential stability issues of formulations AF1, AF2 and AF3 (containing only PPG, PEG, water and a cannabinoid) versus formulation AF4 which contains further excipients to stabilize the claimed cannabinoid formulation.
Regardless of whether this interpretation is still applied to the claimed invention, even relying upon Applicant’s interpretation of “consisting essentially of” so that the formulation so as to exclude those excipients that affect solvation and/or emulsification, the claim remains prima facie obvious as detailed by the rejection 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, 31-32, 35, 39, 43, and 78-84 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2013/0296398 A1 (Whalley US Pub 398) in view of US 20110306660A1 (US Pub 660) and Buck PharmD, Contributing Editor: A Guide to Pharmaceutical Excipients," Pediatric Pharmacotherapy, Newsletter Children’s Medical Center at the University of Virginia Volume 2 Number 9 September 1996 (Pediatric Pharmacotherapy 1996). Whalley US Pub 398 and Pediatric Pharmacotherapy 1996 were previously cited by the Examiner. US Pub 660 is cited as US Pub Ref. 17 on the IDS dated 4/11/2022.
Claim 26 is a method of reducing seizure frequency in a pediatric subject with refractory epilepsy, comprising orally administering to the subject an alcohol-free composition consisting essentially2 of
20% to 35% w/w cannabidiol having a purity of greater than 98% w/w;
5% to 30% w/w polyethylene glycol [PEG];
5% to 35% w/w propylene glycol [PPG]; and
4% to 8% w/w water;
wherein the composition contains less than 0.3% w/w delta-9-tetrahydrocannabinol.
Regarding claim 26 and treatment of a pediatric patient with refractory epilepsy, Whalley US Pub 398 teaches the need to treat epileptic seizures during childhood. See paragraph 24. Whalley US Pub 398 teaches treatment of the subject who is refractory to existing medication. See claim 6 and paragraph 48.
Whalley US Pub 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.
While not disclosing the claimed percentage amounts of CBD for the treatment of pediatric epilepsy, a PHOSITA would routinely optimize concentrations of CBD in a formulation, based on the known dosage of 300 mg/day of CBD administered to the pediatric patient.
With regard to the purity limitation of claim 26 of greater than 98%, while not explicitly recited in Whalley US Pub 398, it nonetheless teaches the administration of isolated CBD, which, given the plain meaning of isolated, is taken to mean a purified version of CBD meeting the claimed purity. See paragraphs 56, 69, 76 and 89.
While disclosing the treatment of a pediatric patient with refractory epilepsy with a composition comprising CBD, Whalley does not teach the claimed orally dosed composition comprising cannabinoid such as CBD, PEG, propylene glycol (PPG) and water. However, the treatment of these patients with a CBD formulation consisting essentially of PEG, PPG and water is known in the art as detailed below.
Regarding claim 26 and the limitations of the orally dosed formulation, US Pub '660 teaches formulations comprising a cannabinoid (such as dronabinol) and the following ingredients: (i) from about 0 to about 40% water, (ii) from about 15 to about 65% alcohol, preferably ethanol, and (iii) a cosolvent that is (a) propylene glycol from about 0% to about 50%, (b) polyethylene glycol from about 0 to about 50%, and/or (c) a combination of (a) and (b), the solution having a combined total of 100%, wherein the formulations are suitable for oral administration, see paragraph 7.
Of note, while the formulation of paragraph 7, with its concentration percentage ranges of water, PPG and PEG overlap those as claimed by claim 26, it also further recites an amount of alcohol.
However, it would be prima facie obvious to substitute art known equivalents one for another, MPEP 2144.06, to replace the amounts of co-solvents, such as ethanol taught by US Pub ‘660 with, functionally equivalents, PPG and PEG. Paragraph 59 teaches PEG, PPG and ethanol as equivalent Co-Solvents. See below.
Co-Solvents
[0059]. In certain embodiments, the co-solvents are organic. Solvents such as dehydrated alcohol, ethanol, propanol, isopropanol, propylene glycol, polyethylene glycol, and combinations there of that are pharmaceutically acceptable based on the desired formulation.
Note paragraph 62 with an emphasis on the two claimed co-solvents, PPG and PEG in ranges overlapping the claimed concentrations.
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It would have been prima facie obvious to a person having ordinary skill in the art (PHOSITA) to replace known co-solvents, one for another so as to arrive at a formulation consisting essentially of a cannabinoid, water, PPG and PEG, in overlapping ranges as those claimed. Also noted is the recognition by a PHOSITA to avoid ethanol formulations with certain patient populations, such as the claimed subject in need, pediatric patients.
Pediatric Pharmacotherapy teaches that since 1993, a committee representing the FDA and Nonprescription Drug Manufacturers Association concluded that OTC products designed for children under 6 should be alcohol free; product for children ages 6-12 should contain no more than 5% alcohol; product for children over 12 years should be limited to 10% alcohol. See page 3, column 1 bridging to column 2.
Regarding the limitations of treatment of epilepsy and similar to Whalley, US Pub ‘660 teach the treatment of epilepsy. See paragraph 91.
Regarding claim 26 and the limitation of cannabidiol (CBD) as choice of cannabinoid for the formulation, US Pub ‘660 states that although its teachings provide a focus on the cannabinoid, dronabinol, a PHOSITA will appreciate the present invention [US Pub ‘660] is applicable to the class of pharmaceutically acceptable cannabinoids, inclusive of cannabidiol (CBD). See paragraph 50.
Prior to the filing of the present patent application, it would have been prima facie obvious to a PHOSITA following the teachings of the primary reference (Whalley US Pub 398) to reduce seizure frequency in a pediatric patient with refractory epilepsy by administering CBD, where per US Pub ‘660, such composition would comprise PEG, propylene glycol and water, (which teaches the art equivalent co-solvents, ethanol, PPG and PEG, prima facie obvious to substitute one for another), which are known to orally dosed, and per Pediatric Pharmacotherapy, where such formulation would be alcohol-free for pediatric patients.
The PHOSITA would have had a reasonable expectation of success because it is known in the prior art to treat the claimed pediatric subjects with the cannabinoid, CBD, where formulation of cannabinoid formulations comprising known equivalent substitutes, (per MPEP 2144.06, ethanol a co-solvent substitute equivalent to PPG and PEG, where a formulation consisting essentially of PEG, PG and water are known to be orally administered to pediatric subjects, who require ethanol free formulations.
With regard to claim 31 and the claimed subject suffering from tonic-clonic (aka grand mal) seizures this taught by Whalley. See Whalley US Pub 398 paragraph 22 for the definition of the condition. See paragraph 48 for the reduction in incidence of tonic-clonic seizures.
As required by claim 32 directed to generalized tonic-clonic (grand mal) seizures, treatment of such is noted by Whalley US Pub 398 paragraph 22 and the definition of tonic-clonic. See also paragraphs 47-48.
Regarding claim 35 and the limitation where the refractory epilepsy comprises infantile spasms, it is pointed out that US Pub 660 teaches treatment of muscle spasms, but not necessarily infantile spasms. See paragraph 91. However, it would be obvious to do so as Whalley US Pub 398 teaches the need to treat epileptic seizures during childhood. See paragraph 24. It would be routine for a PHOSITA to optimize treatment of spasms in pediatric refractory epilepsy subjects, including in infants.
Regarding claim 39 reciting synthetically prepared cannabidiol (CBD), it is noted that the isolated CBD would be the same as the synthetically prepared CBD of claims 39 and 56. 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. 3
Regarding claim 43 and the limitations of wherein the composition comprises about 0.01 to about 1 % w/w of alpha-tocopherol, Murty US Pub 583 teaches alpha-tocopherol. See paragraph 55. Murty US Pub 583 teaches the antioxidant is in the range of 0.01-15 wt %; 0.01-12.5 wt %. See paragraphs 58 and 61 respectively.
Regarding claims 78-79 and the limitations of concentrations of PEG and propylene glycol claimed therein, US Pub ‘660 teaches ranges of PEG and propylene glycol that encompass those claimed, (a) propylene glycol from about 0% to about 50%, (b) polyethylene glycol from about 0 to about 50%, see paragraph 7.
Regarding claim 80 and the limitation where the composition comprises 30% to
35% w/w cannabidiol, while not disclosing the claimed percentage amounts of CBD for the treatment of pediatric epilepsy, a PHOSITA would routinely optimize concentrations of CBD in a formulation, based on the known dosage of 300 mg/day of CBD administered to the pediatric patient. See claim 1.
Regarding claim 81, wherein said cannabidiol is prepared synthetically and has a purity greater than 99% w/w, it is noted that the isolated CBD would be the same as the synthetically prepared CBD of claims 39 and 56. 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 81 of greater than 99%, 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.
Regarding claim 82 wherein said cannabidiol has a purity greater than 99.5% w/w, 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.
Regarding claim 83 and the limitation of further comprising excipients such as flavoring agent/sweetener, antioxidant/preservative or combinations thereof, US Pub ‘660 teaches use of the stabilizers, i.e. antioxidants/preservatives BHA and BHT. See paragraph 20. See also paragraph 25 listing various antioxidants. Paragraph 64 of US Pub ‘660 teaches flavoring agents, sweeteners or taste masking agents, among other excipients.
Regarding claim 84, similar to claim 26, the combined teachings of US Pub ’660, Whalley US Pub 398 and Pediatric Pharmacotherapy 1996 teach the claimed method of treating the claimed subject in need, with a CBD, PEG, propylene glycol and water composition with taught and overlapping concentrations or CBD concentration range that can be routinely optimized from the art teachings of dosing 300 mg/day of CBD.
RESPONSE TO ATTORNEY ARGUMENTS:
The Attorney response states that the transitional phrase “"consisting essentially of," excludes unrecited formulation components which materially affect the solvation/emulsification of the liquid composition, such as unrecited co-solvents, oils and surfactants. “Therefore, a basic and novel characteristic of the claimed invention is the combination of PEG, PG, and water as the formulation vehicle, while being stable and "alcohol free."” See Attorney response citing to specification at paragraphs 18-40. The Attorney response argues consist essentially of allows for unrecited components (e.g., sweeteners, flavoring agents, preservatives) excluding the above components affecting solvation and emulsification.
The Attorney response notes US Pub ‘660 teaches a formulation comprising about 15 to about 65% alcohol, preferably ethanol, where a PHOSITA would have to choose from a genus of cannabinoids and ignore ethanol containing CBD formulations, with no expectation of success to do so regardless of Pediatric Pharmacotherapy 1996. The Attorney response states the general knowledge of Pediatric Pharmacotherapy does not readily translate to CBD and THC, where Whalley and Pediatric Pharmacotherapy do not teach the claimed invention.
In response, US Pub 660 teaches the art known equivalent co-solvents such as ethanol, PEG and PPG. See paragraph 7. US Pub 660 teaches a cannabinoid formulation comprising ethanol, PPG, PEG and water in overlapping concentrations as claimed, with regard to PPG, PEG and water.
Accordingly, it would have been prima facie obvious for a PHOSITA to substitute art recognized equivalents, such as ethanol for PPG and PEG so as to arrive at the claimed invention consisting essentially of PPG, PEG, water and a cannabinoid, where US Pub ‘660 teaches overlapping concentrations of water, PPG and PEG as claimed.
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 be reached M-F.
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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 USSN 14724351, filed 05/28/2015 and issued as US PAT 11224660. USSN: 14724351 claims earlier domestic priority to PRO 62154660 filed 04/29/2015 and PRO 62004495 filed 05/29/2014.
2 Interpreting claim 26 MPEP 2111.03 III., notes the transition phrase “consisting essentially of” limits the scope of the claim to specified materials or steps “and those that do not materially affect the basic and novel characteristic(s)” of the claimed invention.
3 See MPEP 2112.01 II. "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id.