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 .
Acknowledgment of Papers Received: Amendment/Response dated 6/9/26.
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, 141-145, 147 and 148 is/are rejected under 35 U.S.C. 103 as being unpatentable over the disclosures of Brunn et al (US 2020/0330423 hereafter Brunn).
Bruun discloses an oral dissolvable or chewable formulation comprising cannabinoids [0055- 0058, Examples]. 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 1.6g 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 1.6g tablet [Table 5]. The formulation further comprises a self-emulsifying system [0102-0108, 0308]. The non-volatile solvents include oils and triglycerides [0115-0118, 0310]. The tablet are formed by dissolving cannabinoid and forming a solution, followed by absorbing that cannabinoid extract to mesoporous aluminum silicates [Example 1, 3, 7]. The solution does not comprise any additional dissolution aids [Example 4]. The formulation further comprises flavors [0311].
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 optimize the ranges and concentrations of the Brunn patent in order to optimize the delivery of the cannabinoids to the body. It would have been obvious to follow these teachings and suggestions with an expected result of a stable oral formulation for oral dissolution.
Response to Amendment
The Declaration under 37 CFR 1.132 filed 6/9/26 is sufficient to overcome the rejection of claims 138, 139 and 141-145 based upon 35 USC 103(a).
Response to Arguments
Applicant’s arguments, see Remarks, filed 6/9/26, with respect to the rejection(s) of claim(s) 138, 139 and 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 Brunn et al (US 2020/0330423). Brunn continues to disclose an oral cannabinoid formulation comprising a cannabinoid solution applied to a mesoporous aluminum silicate. The reference discloses the same concentration and broad ratios of the instant claims, as well as the same non-volatile solvents. These disclosures of Brunn render the instant claims obviated. Brunn also discloses that the cannabinoid solution can be free of additional dissolution aids in Example 3 and 4. The ratio of the solvent to the cannabinoid can be 1:1. Based on the tablet embodiment the concentration of the carrier and the solvent can be within the ranges of the claims. These disclosures continue to render the claims obvious.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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.
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, 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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MICAH PAUL YOUNG/Primary Examiner, Art Unit 1618
Prosecution Insights