DETAILED ACTION
Claims 11-26 are pending in the instant application.
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 .
Priority
The instant application claims priority to 371 of PCT/CN201/071115 filed on 01/11/2021 which claims priority to CHINA 202011596414.7 filed on 12/29/2020.
Information Disclosure Statement
The information disclosure statement (IDS) submitted are in compliance with the provisions of 37 CFR 1.97, except where noted. Accordingly, the information disclosure statement was considered by the examiner. Please see attached initialed Forms 1449.
Claim Rejections - 35 USC § 112(b)
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.
Claim 12 is 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 contains acronyms which must be spelled out.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
(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 11-14 and 16-17 are rejected under 35 U.S.C. 102(a)(1)(a)(2) as being anticipated by Zerbe et al. (US 2011/0028431 A1).
Zerbe discloses a formulation comprising a non-ionic polymeric solubility enhancer, a mucoadhesive polymer, and an active agent. Cannabinoid-cyclodextrin complexes exhibiting an improved property selected from improve stability, higher product yield and improved product uniformity may be obtained by complexing the cannabinoid with the cyclodextrin in a liquid medium (Abstract). The invention provides, among other things improved processes for making cannabinoid-cyclodextrin complexes and other complexes between a pharmaceutically active agent that can be dispersed in a liquid medium and complexed with cyclodextrin exhibiting enhanced stability, pharmaceutical formulations exhibiting improved stability, bioavailability and/or absorption of cannabinoids when administered, and dosage forms for administration of cannabinoids ([0015]). The process involves suspending at least one cannabinoid and cyclodextrin in a liquid medium to form a complex ([0016]). The non-ionic polymeric solubility enhancers can be poloxamers in an amount of from about 1 to 30% by weight of the formulation or dosage form ([0021]). The active agent can be prepared in an amount of from about 5 to 65% by weight of the formulation ([0024]). Conventional ratios of cyclodextrin to cannabinoid may be employed during preparation of the complexes of the invention (e.g., form about 1 part by weight to about 10 parts by weight of cyclodextrin for 1 part by weight of cannabinoid) ([0047]). Furthermore, Zerbe discloses that the polymer can be in an amount of 1 to 30% by weight; and the active agent is a water-soluble complex of a cannabinoid and a cyclodextrin present in an amount of 5 to 65% by weight of the solid oral dosage form (Claim 15). Cannabinoid can be cannabidiol, cannabinol ([0034]). Zerbe discloses an example of poloxamer, poloxamer 407 (lutrol 127), utilized within the formulation ([0029], Table). Examples of cyclodextrins include alpha, beta, gamma-cyclodextrin and derivatives of beta-cyclodextrin ([0025]).
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 11-26 are rejected under 35 U.S.C. 103 as being unpatentable over Zerbe et al. (US 2011/0028431 A1) and Karolchyk (US 2020/0085740 A1).
Zerbe discloses a formulation comprising a non-ionic polymeric solubility enhancer, a mucoadhesive polymer, and an active agent. Cannabinoid-cyclodextrin complexes exhibiting an improved property selected from improve stability, higher product yield and improved product uniformity may be obtained by complexing the cannabinoid with the cyclodextrin in a liquid medium (Abstract). The invention provides, among other things improved processes for making cannabinoid-cyclodextrin complexes and other complexes between a pharmaceutically active agent that can be dispersed in a liquid medium and complexed with cyclodextrin exhibiting enhanced stability, pharmaceutical formulations exhibiting improved stability, bioavailability and/or absorption of cannabinoids when administered, and dosage forms for administration of cannabinoids ([0015]). The process involves suspending at least one cannabinoid and cyclodextrin in a liquid medium to form a complex ([0016]). The non-ionic polymeric solubility enhancers can be poloxamers in an amount of from about 1 to 30% by weight of the formulation or dosage form ([0021]). The active agent can be prepared in an amount of from about 5 to 65% by weight of the formulation ([0024]). Conventional ratios of cyclodextrin to cannabinoid may be employed during preparation of the complexes of the invention (e.g., form about 1 part by weight to about 10 parts by weight of cyclodextrin for 1 part by weight of cannabinoid) ([0047]). Furthermore, Zerbe discloses that the polymer can be in an amount of 1 to 30% by weight; and the active agent is a water-soluble complex of a cannabinoid and a cyclodextrin present in an amount of 5 to 65% by weight of the solid oral dosage form (Claim 15). Cannabinoid can be cannabidiol, cannabinol ([0034]). Zerbe discloses an example of poloxamer, poloxamer 407 (lutrol 127), utilized within the formulation ([0029], Table). Examples of cyclodextrins include alpha, beta, gamma-cyclodextrin and derivatives of beta-cyclodextrin ([0025]).
Zerbe discloses that the cannabinoid-cyclodextrin complexes are prepared by dispersing a cannabinoid, cyclodextrin, an optional surfactant, and an optional antioxidant in a liquid medium. The ingredients may be added in any order ([0041]). The liquid medium may be removed to obtain a solid material containing the cannabinoid-cyclodextrin complex ([0043]). Typically, the liquid medium is removed by evaporation. However, other techniques such as microfiltration and lyophilization are contemplated ([0045]). The formulation can also include lyoprotectants and/or water-soluble saccharides such as lactose, mannitol, glucose, sorbitol, xylitol ([0023]). The formulation also includes pH regulators such as citric acid, tartaric acid, acetic acid (claim 26).
Solid material is comprised of finely divided particles that may be regarded as a powder or powder-like material. The term “solid material” encompasses other materials that can be handled like a powder such as semi-solid materials ([0044]).
Zebe does not explicitly mention inhalation or enteric formulation.
Karolchyk discloses a water-soluble, powdered cannabinoid (Abstract). The emulsifiers include poloxamer 188 and 407 ([0025]). The invention allows cannabinoid oil to be used in formulation containing dry powders such as tablets, capsules, injectables, dry powder inhalers ([0005]). Oral dosage forms may be provided with suitable coatings resistant to gastric juices ([0039]).
Therefore, it would have been obvious to one of ordinary person in the art before the effective filing date of the claimed invention to have combined teachings of above to arrive at a water-soluble cannabinoid solid granule comprising cannabinoid, cyclodextrin, and an amphiphilic high molecular polymer. This is taking some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Regarding claim 12, cannabinoids are discussed above.
Regarding claims 13-14, poloxamers are discussed above.
Regarding claim 15, One of ordinary skill in the art would routinely experiment with various poloxamers within a cannabinoid formulation since it increases solubility as taught by Zerbe.
Regarding claims 16-17, cyclodextrins are taught above.
Regarding claim 18, a preparation method is taught by Zerbe.
Regarding claims 19-20, lyoprotectant and pH regulators are taught by Zerbe. Furthermore, one of ordinary skill in the art would routinely experiment with various concentrations of each component within a pharmaceutical formulation.
Regarding claim 21, lyophilization is taught above.
Regarding claims 22-23, oral formulations and soli formulations are discussed above.
Regarding claim 24, Karolchyk discloses that various formulation modifications as well as method of delivery modifications may be made ([0042]). Furthermore, one of ordinary skill in the art would contemplate various oral formulations such as an effervescent tablet, a sustained-release tablet, a disintegrating tablet and a dripping pill.
Regarding claim 25, nasal inhalation powder is disclosed by Karolchyk ([0031]).
Regarding claim 26, enteric coating is discussed above.
Conclusion
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/JOHN SEUNGJAI KWON/Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615