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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 03/16/2026 has been entered.
Response to Arguments
Applicant's arguments filed 03/16/2026 have been fully considered but they are not persuasive. Applicant argues (Page 2) the teachings of Murty instead of suggesting that cyclodextrin concentration be constrained within a narrow range, Murty would have led a skilled person away from the limiting cyclodextrin content and toward increasing it in pursuit of improved solubilization. Applicant additionally argues prior art teaching of Murty teaches away from the claimed invention, in particular the claimed weight ratio of cyclodextrin to emulsifier and cannabinoid to cyclodextrin. It is noted from previous office action the concentration of cannabinoid to cyclodextrin is within the desired range wherein the concentration of cyclodextrin is sufficient for the bioavailability of the compound. Additionally, the concentrations range of cannabinoid to cyclodextrin and cannabinoid to silica derivative falls within the claimed range.
Applicants’ affidavit filed 03/17/2026, which teaches the unexpected results of the dissolution formulations A-E over the claimed ratios of cannabinoid, cyclodextrin, emulsifier and silica derivative is rendered moot to the teachings of Murty. Murty teaches the claimed compounds within the claimed ratio ranges. Thus the teachings of Murty anticipates claimed invention and would not be overcome by applicants unexpected results per MPEP 2131.04: Evidence of secondary considerations, such as unexpected results or commercial success, is irrelevant to 35 U.S.C. 102 rejections and thus cannot overcome a rejection so based. In re Wiggins, 488 F.2d 538, 543, 179 USPQ 421, 425 (CCPA 1973). For the above reasons the rejections of record are maintained.
Applicant has canceled claims 7-9, claims 1-4 and 10-26 is now pending. Claims 1-4 and 10-26 are now evaluated on its merits.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-4, 10-18 and 23 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Murty et al. (US 20160184258 A1).
Regarding claims 1-4, 10-18 and 23, Murty teaches an improved oral gastrointestinal dosage form delivery system composition comprising a mixture of cannabinoids of THC, CBD, CBDV, cannabigerol (CBG), cannabinol (CBN) (relevant to claims 2-4) (para. 0042), emulsifier of Polysorbate 80 (relevant to claims 11-14) (para. 0086), silica derivative of colloidal silicon dioxide (para. 0041) and cyclodextrin compound of β-cyclodextrin (relevant to claims 15-17) (para. 0071). Of the composition Murty teaches the cannabinoid at concentrations of about 1-60% wt (paragraph 0050), Polysorbate 80 concentration of about 1-5% wt (para. 0086), colloidal silicon dioxide concentration of about 1-70% wt (para. 0041) and β-cyclodextrin concentration of about 1-70% wt (para. 0046).
Murty et al. further teaches the emulsifier at a HLB value between 11-12 (relevant to claim 10) (para. 0177) and silica derivative of colloidal silicon dioxide as hydrophilic (relevant to claim 18) (para. 0076). The mixture of the agents as taught by Murty et al. are being performed at temperatures of 35-40 °C and 65-70° C (example 19). For preferred embodiments Marty et al. teaches the cyclodextrin B from 10-50 wt % (para. 0079) and colloidal silicon dioxide from 7.5 to 10 wt% (para. 0081), in addition Tables 1-8 (pages 9-13) reflects the cannabinoid THC all in concentrations of 3.85 and cosolvent at 1.925%. Thus, with the teaching of β-cyclodextrin as interchangeable for the tested cosolvent, the 1.925 % β-cyclodextrin to 1-5% Polysorbate 80 produces the ratio 1:1 to 1.15, cannabinoid 3.85 % to cyclodextrin 1.925 % produces a ratio of 1:0.5, cannabinoid 3.85 % to colloidal silicon dioxide of 10% produces a 0.385:1 ratio (relevant to claim 1).
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, 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.
Claims 19-22 are rejected under 35 U.S.C. 103 as being unpatentable over Murty et al. (US 20160184258 A1) in view of Carpanzano et al. (US 20160361261 A1).
The teachings of Murty are set forth in the above 102 rejection of claims 1-4, 10-18 and 23 is incorporated herein by reference. Murty does not teach colloidal silicon dioxide with the surface area, particle size and density limitations of claims 19-22.
Regarding claims to claims 19-22, Carpanzano teaches excipients for manufacturing oral tablets containing oily drugs as well as pharmaceutical compositions containing the same, in which the excipient silica derivative of colloidal silicon dioxide, .01 to 20 wt %, is used as being hydrophilic with an average particle size from 10 to 500 microns (para. 0033), BET surface area from 50 to 400 m2/g (para. 0087) and bulk density from 20 to 100 g/l (para. 0086). Carpanzano further teaches the properties in a gastrointestinal drug; colloidal silicon dioxide is used to maintain integrity during storage and being excellent for disintegration and dissolution (para. 0028).
Therefore, it would have been obvious to someone of ordinary skill in the art at the time of filling to have used the silica derivative colloidal silicon dioxide taught by Carpanzano having a mean particle diameter of between 10 to 250 microns, BET surface area between 40 to 400 m2/g and tamped density between 50 to 600 g/L to form an oral gastrointestinal drug. One would have been motivated to do so from the teachings of Carpanzano on oral gastrointestinal drug excipient of colloidal silicon dioxide properties and Murty teachings of the same excipient for oral gastrointestinal dosage. The teachings of Capranzano on the colloidal silicon dioxide properties described above provides enhancement for absorbing and maintaining oils and oily drugs in solid dosages (para. 0022-0023) for the gastrointestinal tract, in which Murty teaches an oily medium improved oral delivery dosage with enhanced bioavailability through the gastrointestinal tract. Thus, it would have been obvious for Murty to have the colloidal silicon dioxide properties of microns, BET surface area and tamped density for maintenance and absorption for the oily medium drug. There would be a reasonable expectation of success in using the amounts taught by Carpanzano to the colloidal silicon dioxide of Murty to form an oral gastrointestinal dosage.
Claims 24-25 are rejected under 35 U.S.C. 103 as being unpatentable over Murty et al. (US 20160184258 A1) in view of Kottayil et al. (JP 2010535774 A).
The teachings of Murty are set forth in the above 102 rejection of claims 1-4, 10-18 and 23 is incorporated herein by reference. Murty further teaches the addition of pH buffers of Acetate and Borate (Table 2). Murty does not teach the oral cannabinoid composition at pH ranges of 3-7.2.
Regarding claims 24-25, Kottayil teaches an oral stable cannabinoid composition at room temperature comprising a stabilizer agent, an emulsifier, silica, cyclodextrin (claim 123) and pH adjuster that gives the composition a pH value from about 5 to about 10 (claim 1). Kottayil further teaches the formulation to be stable for the gastrointestinal tract with the pH being of the claimed ranges.
Therefore, it would have been obvious to have formulated the oral gastrointestinal dosage taught by Murty with the pH value of about 5 to 7.2. One would have been motivated to do so because the teachings of Kottayil is of the same active ingredients of an emulsifier, silica, cyclodextrin, cannabinoid and pH buffer as taught by Murty. There would be a reasonable expectation of success with formulation of an oral composition with the active ingredients taught by Murty to produce a composition having the pH range of 5 to 7.2 as taught by Kottayil.
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Murty et al. (US 20160184258 A1) in view of Park et al. (US 20100092564 A1).
The teachings of Murty are set forth in the above 102 rejection of claims 1-4, 10-18 and 23 is incorporated herein by reference. Murty fails to teach the claimed room temperature mixture and sieve range of 200 µm to 2000 µm.
Park et al. teaches an orally dissolving tablet method of manufacturing (abstract) comprising hydrophobic, lubricant and disintegrant agents which forms granulates of about milled 700 µm particle size after being mixed and wet dried (para. 0022 and claims 21-22).
Therefore, it would have been obvious to someone of ordinary skill in the art at the time of filling to have formulated the composition taught by Murty by mixing the composition agents at room temperature and sieving the powder within the desired range of 200 to 2000 µm. One would have been motivated to do so from the teachings of Murty of mixing the active ingredients, thus of room temperature is of routine experimentation to one skilled in the art unless deemed to have unexpected outcomes as evidenced in MPEP § 2144.05 (II) “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[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)”. Murty et al. further recites those having ordinary skill in the art will make changes in the specific embodiments without changing the scope of the disclosure.
One would also be motivated to sieve the mixture taught by Murty within the claimed range of 200 µm to 2000 µm because Park teaches the method of manufacturing an orally dissolving tablet containing hydrophobic agents and lubricants yields by milling granulate particle size of about 700 µm. The process of sieving and milling are well known in the art to be of the same process. There would be a reasonable expectation of producing about 700 µm particle size powder from the mixture of agents taught by Murty et al. by the method taught by Park.
Conclusion
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MIKHAIL O'DONNEL. ROBINSON
Examiner
Art Unit 1627
/MIKHAIL O'DONNEL ROBINSON/Examiner, Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627