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 .
Status of the Application
Claims 1-15 are pending
Claims 1-15 are under consideration in the instant office action.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 03/20/2023 complies with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609. Accordingly, it has been placed in the application file and the information therein has been considered as to the merits. See attached copy of the PTO-1449.
Priority
This application claims benefit of Czech Applications No. CZPV 2020-620 filed on 11/19/2020, and PCT Application No. PCT/CZ2021/050136 filed on 11/17/2021.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 6 and 12-13 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 12 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential steps, such omission amounting to a gap between the steps. See MPEP § 2172.01. The omitted steps are: active steps of treating or administering to a subject.
The term “damaged” in claim 13 is a relative term which renders the claim indefinite. The term “damaged” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear what criteria determines a tissue damaged.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 6 recites the broad recitation “5 to 20% w/w”, and the claim also recites “preferably 7 to 15 %” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
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.
Claims 1-15 are rejected under 35 U.S.C. 103 as being unpatentable over Changoer et al. (US 2018/110753, as disclosed in IDS) in view of De Villiers (Suppository Bases, 10/19/2008, XP055884435, Internet, as disclosed in IDS), Glick et al. (US 2017/0056347), and Takatori et al. (Evaluation of sustained release suppositories prepared with fatty base including solid fats with high melting points, International Journal of Pharmaceutics, 2004, 278, pp. 275-282).
Changoer et al. teaches suppository compositions comprising cannabinoids including cannabidiol, and methods of treating pain and inflammatory bowel diseases comprising administering such compositions (see abstract; paragraph 0048). Changoer et al. teaches administering the suppository 1-6 times a day (paragraphs 0033-0036). Changoer et al. teaches such compositions further comprising hyaluronic acid derivatives (paragraph 0056; claims 7-9). Changoer et al. teaches cannabinoids present in an amount of 0.1% to 50% (paragraph 0059).
Changoer et al. does not teach a suppository composition further comprising sodium hyaluronate, fat, water, and glycerol monostearate present in the recited amounts.
Glick et al. is drawn towards compositions useful for treating an abnormal inflammatory response such as inflammatory bowel diseases (see abstract). Glick et al. teaches such compositions in the form of suppositories (paragraphs 0147-0148), which can comprise sodium hyaluronate (paragraph 0119), water (paragraph 0141), and glycerol monostearate (paragraph 0217).
Takatori et al. is drawn towards the use of fatty bases including solid fats in suppositories (see abstract). Takatori teaches that incorporation of solid fats provides for control of the rate of drug release from the suppository for maintaining the plasma concentration of drugs for longer time periods (see abstract).
It would have been obvious to one of ordinary skill in the art to formulate a suppository further comprising sodium hyaluronate, fat, water, and glycerol monostearate present in the recited amounts, as suggested by Glick et al. and Takatori et al., and produce the instant invention.
One of ordinary skill in the art would have been motivated to do so since such components are commonly formulated for suppository compositions used for the treatment of inflammatory bowel diseases, and the incorporation of solid fat provides for controlled release of the active agent as taught by Takatori et al. (see abstract), with a reasonable expectation of success absent evidence of criticality of the particular formulation.
With regards to the limitation claimed in instant claims 2-4, 6, and 9-11, which claims the concentrations of cannabidiol, sodium hyaluronate, fat, water, and glycerol monostearate, Changoer et al., Glick et al., and Takatori et al. do not specifically teach the exact amounts claimed in instant claims 2-4, 6, and 9-11. However, it would be within the skill of an ordinary artisan to be able to modify the concentrations in order to obtain the desired bioavailability of cannabidiol. It is noted that "[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).
Conclusion
Claims 1-15 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW P LEE whose telephone number is (571)270-1016. The examiner can normally be reached Monday-Friday 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Renee Claytor can be reached at (571)272-8394. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANDREW P LEE/Examiner, Art Unit 1691
/RENEE CLAYTOR/Supervisory Patent Examiner, Art Unit 1691
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