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 .
Priority
This application, filed 7 October, 2022, is a national stage application of PCT/CA2021/050478, filed 9 April, 2021, which claims the benefit of U.S. provisional application 63/007,529, filed 9 April, 2020.
Information Disclosure Statement
Two information disclosure statements (IDS) submitted on 7 October, 2022 and 27 April, 2023 are acknowledged and have been considered.
Status of the Application
Receipt is acknowledged of Applicant’s claimed invention, filed 7 October, 2022, in the matter of Application N° 17/917,715. Said documents have been entered on the record.
No additions, amendments, or cancellations have been made to the originally-filed claims. The issue of new matter is moot.
Thus, claims 1-3 represent all claims currently under consideration.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-3 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon without significantly more.
Claims 1-2 recite a formulation comprising CBD (a naturally occurring phytocannabinoid) and a PPAR agonist, wherein the PPAR agonist is an Omega-3 based PPAR. However, hemp seed oil has been shown to contain both α-linoleic acid, a PPAR agonist (Yang et al. “α-linolenic acid inhibits human renal cell carcinoma cell proliferation through PPAR-γ activation and COX-2 inhibition”, Oncology Letters, 2013, 6, 197-202, cited in the IDS) and trace amounts of CBD (Leizer et al., "The composition of hemp seed oil and its potential as an important source of nutrition", Journal of Nutraceuticals, Functional & Medical Foods, 2000, 2(4), 35-53. Cited in the IDS.)
Regarding Claim 3, some fish oils are known to comprise substantially equal parts DHA and EPA. Given CBD is a naturally occurring phytocannabinoid, and DHA and EPA can be found in equal amounts in some fish oils, the claimed composition represents a combination of natural products.
This judicial exception is not integrated into a practical application because the applicant is claiming a formulation of matter, which includes compounds which naturally occur, and not a novel method of use. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claimed formulation includes naturally occurring substances. The mere inclusion of naturally occurring materials is not considered inventive because such substances are readily available and well-known in the art.
The specification does not provide any inventive means by which these naturally occurring substances are selected or manipulated in a manner that confers patentability beyond their natural existence.
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.
Claims 1-3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Anavi-Goffer (WO 2018/112138 A1.)
Anavi-Goffer teaches methods comprising administering a fixed drug combination composition comprising therapeutically effective amounts of at least two therapeutic agents selected from the group consisting of cannabidiol (CBD) and omega-3 fatty acids (‘138, Pg. 6, Lines 5-10.) Furthermore, Anavi-Goffer teaches that in omega-3 fatty acid the ratio of EPA to DHA can be 1:1 (‘138, Pg. 17, Lines 17-18.)
As such, Claims 1-3 are anticipated by Anavi-Goffer.
Claims 1-3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jha (WO 2018/145213 A1, cited in the IDS as CA3053187A.)
Jha teaches a pharmaceutical formulation comprising cannabidiol (CBD) with one or more omega-3 fatty acids, comprising eicosahexaenoic acid (EPA) and/or docosahexaenoic acid (DHA) in a concentration of 200-3000 mg/ml of EPA/DHA combined (‘213, Pg. 5, Para 0020.)
Although Jha does not explicitly recite a ~1:1 ratio of DHA to EPA, the disclosure of a generic combination encompasses all possible ratios, including the “substantially equal parts” as claimed. As such, Claims 1-3 are anticipated by Jha.
Claims 1-2 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Leizer et al. ( "The composition of hemp seed oil and its potential as an important source of nutrition", Journal of Nutraceuticals, Functional & Medical Foods, 2000, 2(4), 35-53. Cited in the IDS), hereinafter Leizer.
Leizer teaches that hemp seed oil contains α-linolenic acid (2000, Introduction, Para 2) and that Cannabidiol (CBD) has been found to be present in hemp seed oil as well (2000, Introduction, Para 3.)
As α-linolenic acid is a known PPAR agonist, Claims 1-2 are anticipated Leizer.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jenn (WO 2020/032988 A1, published 13 February, 2020.)
Jenn teaches an ingestible dosage form for enhancing sexual response and sensitivity in a human, comprising: an ingestible cannabinoid component comprising cannabidiol (CBD); and a therapeutically effective amount of an herbal supplement comprising ginseng (e.g., Korean red ginseng) (‘988, Pg. 24, Claim 11.)
As the applicant contemplates alternative forms of PPAR agonists that might be useful can include Panax ginseng (instant Specification, Pg. 13, Para 0108), Claim 1 is therefore anticipated by Jenn.
Conclusion
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/D.M.N./ Examiner, Art Unit 1627
/Kortney L. Klinkel/ Supervisory Patent Examiner, Art Unit 1627