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 .
According to paper filed on June 18, 2026, the applicants have elected species II (Cannabidiol) for further prosecution.
Claims 1-12 are pending in the application.
Claim Rejections - 35 USC § 112
4. 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 2 and 3 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.
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 2 recites the broad recitation less than 20 wt%, and the claim also recites less than 15wt%, 10wt%,5wt%,3wt%and 1wt% which is the narrower statement of the range/limitation.
Similarly, Claim 3 recites the broad recitation at least 1.25 fold, and the claim also recites more preferably at least 1.5 fold, 1.75 fold, 2 fold and 3 fold 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 § 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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-12 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Czap (U.S. Patent 11,633,448 B2).
Czap discloses controlled release and stratified cyclodextrin inclusion complex vehicles. The inclusion complexes and method of preparing them (see example 14 in columns 23-24) as well as pharmaceutical composition comprising these inclusion complexes for oral delivery and sustained release formulation disclosed in claims 1, 6-7 and 9-10 by Czap anticipate the instant claims when active pharmaceutical ingredient (API) is represented by acetaminophen or N-acetylcysteine in the instant 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.
10. 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.
11. Claims 1-12 are rejected under 35 U.S.C. 103 as being unpatentable over McGowan (WO 2020/223393 A1).
McGowan discloses methods for forming inclusion complexes with hydrophilic beta-cyclodextrin derivatives. McGowan teaches applications of cyclodextrins in the pharmaceutical field (see paragraphs 0056 and 0057 on page 18). McGowan also teaches that Cannabidiol (CBD) is insoluble in water and therefore, complexing with cyclodextrin allows oral controlled release systems for drugs with low water solubility (see paragraph 0053 on page 96). McGowan meets all the limitations of instant claims except that McGowan does not teach pharmaceutical composition comprising CBD inclusion complex for sustained release formulation following oral administration. However, McGowan does teach that dissolution profile of HPBCD CBD complex adopts the characteristic shape of a sustained release profile (see paragraph 0053 on page 96) and also teaches pharmaceutical compositions comprising inclusion complexes for sustained release following oral administration (see claims 1-5 and 7-9). Therefore, it would have been obvious to one skilled in the art to prepare pharmaceutical composition comprising CBD inclusion complexes for sustained release following oral administration with reasonable expectation of success.
12. Claims 1-12 are rejected under 35 U.S.C. 103 as being unpatentable over Pin (J. Drug Deliv. Sci. and Technol.) in view of Czap (US 2017/0224841 A1).
Pin discloses that inclusion complexes of CBD with three cyclodextrins increases their water solubility and in vitro cytotoxicity compared to CBD. Czap meets all the limitations of instant claims except that Pin does not teach pharmaceutical composition comprising CBD inclusion complex for sustained release formulation following oral administration. However, Czap teaches cyclodextrin inclusion complexes comprising active pharmaceutical ingredients including CBD for sustained release formulations following oral administration (see claims 1 and 9-17, specifically claims 14, 15 and 17). Therefore, it would have been obvious to one skilled in the art to prepare pharmaceutical composition comprising CBD inclusion complexes for sustained release following oral administration with reasonable expectation of success.
IMPROPER MARKUSH GROUP
13. Claims 1-12 are rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping of claims 1-12 is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons: In the instant claims, the structure of the active pharmaceutical ingredient (API) is critical for the common core of these inclusion complexes.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
14. Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHARANJIT AULAKH whose telephone number is (571)272-0678. The examiner can normally be reached Monday-Friday 7:00-3:30.
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, Clinton A Brooks can be reached at 571-270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHARANJIT AULAKH/ Primary Examiner, Art Unit 1621
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