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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 2/9/26 has been entered.
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.
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) 138, 139 and 141-145 is/are rejected under 35 U.S.C. 103 as being unpatentable over the combined disclosures of Nowak et al (US 2020/0046787 A1 hereafter Nowak) in view of Bruun et al (US 2020/0330423 A1 hereafter Brunn).
Nowak discloses an orally dissolvable tablet powder formulation comprising mesoporous silica carriers [0017, 0023, 0048]. The formulation water soluble agents comprise sugar alcohols and flavors like mannitol, sorbitol, sucrose and glucose [0056, 0064]. Cannabinoids are dissolved in a non-volatile solvent and form a solution that is absorbed into the mesoporous carrier, where the solvents include oils and triglycerides [p0041]. The ratio of the active agent to the solvent is 1:10 [Table 2].
The reference discloses the use of sorbitol but does not disclose the concentration of sorbitol of the instant claims. The use of sorbitol in oral cannabinoid formulations is well known in the art as seen in the Bruun patent.
Bruun discloses an oral dissolvable or chewable formulation comprising cannabinoids [0055-0058]. The formulation comprises sugar alcohol particles, where the sugar alcohol is sorbitol [0011, 0070]. The sorbitol is present at least 30%, more preferably at least 50% [0153, Table 8]. The formulation further comprises magnesium aluminum silicates [0322]. These silicates would be processing aids which are present about 0.5% or at least 80 mg of a 1.6 g tablet [Table 5]. The cannabinoid can be an isolate of 98.5% purity [Example 4]. The ratio of the cannabinoid : to solvent can be 1:1 [Example 1]. The solvents, being 50% of the extract, would be half of the 2.273% of the tablet, about 18 mg of a 1.6 g tablet [Table 5]. The formulation further comprises a self-emulsifying system [0102-0108, 0308]. The non-volatile solvents include triglycerides [0115-0118, 0310]. It would have been obvious to include these components as well as the sorbitol concentration into the formulation of Nowak as they solve the same problem.
Regarding the ratios and concentration of the instant claims, it is the position of the Examiner that said claims do not distinguish over the claims. The prior art discloses an orally disintegrating tablet or powder comprising cannabinoid absorbed onto mesoporous silica carriers meeting the general conditions of the claims. Where 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. See In re Aller, 220 F.2d 454 105 USPQ 233, 235 (CCPA 1955).
With these aspects in mind, it would have been obvious to combine the prior art in order to produce a stable oral dosage form comprising solubilized cannabinoids absorbed onto mesoporous silica carriers useful in treating pain quickly. It would have been obvious to combine the carriers and components of Bruun into the similar formulation of Nowak as they solve the same problem. One of ordinary skill in the art would have been motivated to combine the components with an expected result of a stable oral formulation for treating pain quickly.
Response to Arguments
Applicant’s arguments, see Remarks, filed 2/8/26, with respect to the rejection(s) of claim(s) 138, 139, 141-145 under 35 USC 103(a) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of the above recited rejection.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICAH PAUL YOUNG whose telephone number is (571)272-0608. The examiner can normally be reached Monday through Friday, 9:00 am to 5:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Hartley can be reached at 5712720616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICAH PAUL YOUNG/Primary Examiner, Art Unit 1618