DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. The amendment filed February 9, 2026 has been received and entered.
3. Claims 1-11 are currently pending.
Election/Restrictions
4. Applicant’s election without traverse of Group I, claims 1-10, and medication for the species in the reply filed on February 9, 2026 is acknowledged.
5. Claims 4-9 and 11 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species and invention, there being no allowable generic or linking claim.
6. Claims 1-3 and 10 are examined on the merits.
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.
7. Claims 1-3 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.
The term “enhancing” in claim 1 is a relative term which renders the claim indefinite. The term “enhancing” 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 types of “enhancements” are encompassed by the claim, and how all potential “enhancements” are quantified. Thus, the metes and bounds of the claims are unclear.
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.
8. Claim(s) 1, 2, and 10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bjorncrantz (US 9,333,229).
This reference teaches a method for making a winterized Cannabis extract by mixing the Cannabis extract with a solvent such as ethanol, chilling to a temperature below -20°C, allowing for the separation of the components for a time sufficient to allow for separation, collecting and refining the lipid fraction by filtering and removal of the solvent. The collected fraction is added to medicinal compositions such as other Cannabis extracts or other medicines to improve the characteristics of the combined components such as improved stability, quality, and taste (see column 3, lines 26-end; column 6, lines 12-65; column 9, lines 25-44; column 10, lines 30-46). The administration of the medicinal composition should also lead to an increased systemic exposure because the same composition as claimed is being administered to a patient.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
9. Claim(s) 1 and 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bjorncrantz (US 9,333,229) in view of Agrify ("What is the Winterization Process in Cannabis Extraction?" Web. 15 June 2020 https://precisionextraction.com/2020/06/what-is-the-winterizaton-process-in-cannabis-extraction/)
The teachings of Bjorncrantz are discussed above. The reference does not teach using a temperature of -80°C during the winterization process. However, Agrify teaches that -80°C is the optimal temperature to use when winterizing Cannabis. Thus, an artisan of ordinary skill would reasonably expect that Bjorncrantz could be modified with success to include the use of this temperature. This reasonable expectation of success would have motivated the artisan to modify Bjorncrantz to include the use of -80°C as a temperature during the winterization process.
10. Claim(s) 1, 2, and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smeeding (US 2019/0224141) in view of Bjorncrantz (US 9,333,229).
Smeeding teaches a method for improving the bioavailability (increased systemic exposure) of a statin by adding a cannabinoid composition to the statin. The reference teaches that the cannabinoid can be a Cannabis extract purified using winterization (see paragraphs 53, 70 and claims 31 and 37). The reference does not teach the specific process used for winterizing.
However, Bjorncrantz teaches a method for making a winterized Cannabis extract by mixing the Cannabis extract with a solvent such as ethanol, chilling to a temperature below -20°C, allowing for the separation of the components for a time sufficient to allow for separation, collecting and refining the lipid fraction by filtering and removal of the solvent. The collected fraction is added to medicinal compositions improve the characteristics of the combined components such as improved stability, quality, and taste (see column 3, lines 26-end; column 6, lines 12-65; column 9, lines 25-44; column 10, lines 30-46). Thus, given these improved characteristics, an artisan of ordinary skill would reasonably expect that using the winterized Cannabis extract produced using the process of Bjorncrantz would improve the cannabinoid and statin composition taught by Smeeding. Therefore, the artisan would have been motivated to use the winterization process taught by Bjorncrantz to produce the winterized Cannabis extract to Smeeding which is then added to a statin composition to improve the bioavailability of the statin composition.
11. Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smeeding (US 2019/0224141) in view of Bjorncrantz (US 9,333,229) as applied to claims 1, 2, and 10 above, and further in view of Agrify ("What is the Winterization Process in Cannabis Extraction?" Web. 15 June 2020 https://precisionextraction.com/2020/06/what-is-the-winterizaton-process-in-cannabis-extraction/)
The teachings of Smeeding and Bjorncrantz are discussed above. The references do not teach using a temperature of -80°C during the winterization process. However, Agrify teaches that -80°C is the optimal temperature to use when winterizing Cannabis. Thus, an artisan of ordinary skill would reasonably expect that Bjorncrantz could be modified with success to include the use of this temperature. This reasonable expectation of success would have motivated the artisan to modify Bjorncrantz to include the use of -80°C as a temperature during the winterization process.
12. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Susan Hoffman whose telephone number is (571)272-0963. The examiner can normally be reached M-Th 8:30am - 5:00pm.
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, Anand Desai can be reached at 571-272-0947. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SUSAN HOFFMAN/ Primary Examiner, Art Unit 1655
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