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 .
Application Status
The preliminary amendment filed on 8/7/2023 is acknowledged. Claims 1-20 are currently pending and under consideration.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements filed on 11/03/2023 and 10/23/2024 have been considered except where lined through.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Interpretation
Claim 20 recites “non-clinical inflammation”. The specification does not appear to be provide a specific definition of what is encompassed by non-clinical inflammation. The state of the art does not appear to specifically define what non-clinical inflammation encompasses, but appears to differentiate generically between “clinical” vs. “non-clinical”, wherein “clinical” seems to involve direct patient care vs. “non-clinical” does not directly interact with patients. Accordingly, an inflammatory condition such as arthritis could encompass both a clinical inflammatory disorder, as well as, a non-clinical inflammatory condition dependent on whether the patient directly gets a diagnosis or does not, but has the symptoms associated with arthritis. For prior art purposes, the examiner will be interpreting a non-clinical inflammatory condition as being interchangeable with a clinical since it appears that the condition is the same.
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 4, 6, 8-11, 13-14,16 and 20 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.
Regarding claims 4, 6, 8-11 and 13-14, the phrase "such as" or “preferably” renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claims 6 and 16, which both ultimately depend from claim 16, recite the limitation "cannabinoid" when referring to a ratio of terpene or oil. There is insufficient antecedent basis for this limitation in the claim because it is unclear whether the ratio is for one cannabinoid such as CBD or all of the cannabinoids since the composition of claim 1 comprises at least two cannabinoids.
Regarding claim 8, claim 8 recites the limitation “… the at least one terpene further comprises alpha-humulene, … and/or an ocimene isomer.” As such, it is unclear whether the claims are attempting to define what the at least one terpene is from the list or whether the composition comprising the at least one terpene further comprises a second terpene chosen from the list. For prior art purposes, the examiner is interpreting this as defining the at least one terpene.
Regarding claim 20, claim 20 recites the phrase “non-clinical inflammation”. The phrase is indefinite because it is unclear how non-clinical inflammation differs from clinical inflammation. For example, a person may be diagnosed with arthritis based on symptoms which would be “clinical”, but could self-diagnose themselves with arthritis based on symptoms which would be non-clinical. However, the arthritis is the same.
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.
Claim(s) 1-3, 10-11, 15-17 and 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Siurkus, Juozas (US20190167749A1, 2019-06-06) as evidenced by Zhu et al. (Front. Immunol. (2024); 15:1333086).
Siurkus, Juozas teaches a composition comprising olive fruit oil (82%), leaf oil (0.5%), Silica colloidal anhydrous (8.2%), about 1% Cannabidiol (CBD) and 1% of Cannabidiolic acid (CBDA), with traces of Cannabivarin (CBV) and Cannabigerol (CBG) (Claim 1 of Siurkus). Moreover, Siurkus, Juozas teaches a method of relieving human pain and inflammation of the deep tissues of skeletal muscles and/or joints resulted from mechanical injury/trauma and/or arthritis/osteoarthritis comprising applying an effective amount of said composition (Claim 5 of Siurkus). Thus, while Siurkus, Juozas does not specifically teach that Toll-like receptor is involved in inflammation, Zhu et al. teach that increasing numbers of studies have demonstrated that Toll-like receptor 4 plays a pivotal role in the development of osteoporosis (abstract). As such, the claimed limitation appears to be met.
Claim(s) 1-5, 12, 15 and 18-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Greenway Herbal Products LLC (WO2020223510A1, 2020-11-05) referred to herein as Greenway.
Greenway teaches a pharmaceutical composition comprising an approximate 1:1 equimolar mixture of CBD and CBDA, wherein may further comprise at least one other cannabinoid chosen from CBG, CBGA and CBDV (Claim 1 of Greenway). Regarding the pharmaceutical composition, Greenway teaches that the pharmaceutical composition includes a carrier such as coconut oil (paragraph 0053). Moreover, Greeway teaches a method of treating inflammation and/or autoimmunity in a subject comprising administering the composition, wherein the autoimmunity condition includes, but is not limited to, rheumatoid arthritis or Crohn’s disease (Claims 41 and 43 of Greenway). Regarding the administration, Greenway teaches that the pharmaceutical composition is administered orally as a medication, nutritional supplement or a food additive (paragraph 0067). Thus, while Greenway does not explicitly teach that the autoimmune disorders are associated with increased IL-6 production, as evidenced by the specification, disorders associated with inflammation, in particular increased IL-6 production included, but are not limited to, rheumatoid arthritis and Crohn’s disease (page 18, lines 17-24). As such, the claimed limitation(s) appear to be met.
Claim Rejections - 35 USC § 103
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 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.
Claim(s) 10-11, 13-14 and 16-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Greenway Herbal Products LLC (WO2020223510A1, 2020-11-05), as applied to claims 1-5, 12, 15 and 18-20 above.
Greenway teaches a pharmaceutical composition comprising an approximate 1:1 equimolar mixture of CBD and CBDA, wherein may further comprise at least one other cannabinoid chosen from CBG, CBGA and CBDV (Claim 1 of Greenway). Regarding the pharmaceutical composition, Greenway teaches that the pharmaceutical composition includes a carrier such as coconut oil (paragraph 0053). Moreover, Greeway teaches a method of treating inflammation and/or autoimmunity in a subject comprising administering the composition, wherein the autoimmunity condition includes, but is not limited to, rheumatoid arthritis or Crohn’s disease (Claims 41 and 43 of Greenway). Regarding the administration, Greenway teaches that the pharmaceutical composition is administered orally as a medication, nutritional supplement or a food additive (paragraph 0067). Greenway further teaches % cytokine suppression by various cannabinoids individually including CBD @ 33.15%, CBG @35.84%, CBGA @ 34.30%, CBDA@ 37.18% and CBDV@ 37.18%, as well as the combination of CBD and CBDA @ 45.51%. Lastly, Greenway teaches that the cannabinoids can be administered at various amounts, wherein a physician or veterinarian can determine and prescribe the effective amount of the pharmaceutical composition required such as by starting at doses lower than that required to achieve the therapeutic effect and gradually increasing the dosage until the desired effect is achieved (paragraph 0069).
The prior art does not specifically choose CBG or CBDV, or the amounts of the cannabinoids and/or oil in the formulation.
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to add CBG or CBDV and optimize the amounts of the cannabinoids and/or oil in the composition taught by Greenway. One of ordinary skill in the art would have been motivated to make such a modification, with a reasonable expectation of success, because:
-Greenway teaches that both CBG and CBDV have higher cytokine suppression than CBD; and
-Greenway teaches that it is well within the purview of a physician or veterinarian to determine the effective amount of the cannabinoids required to achieve the desired therapeutic effect.
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[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).
Moreover, "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
Claim(s) 6-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Greenway Herbal Products LLC (WO2020223510A1, 2020-11-05), as applied to claims 1-5, 12, 15 and 18-20 above, in further view of Kim et al. (Int. J. Mol. Sci. 2020; 21(6), 2187).
Greenway teaches a pharmaceutical composition comprising an approximate 1:1 equimolar mixture of CBD and CBDA, wherein may further comprise at least one other cannabinoid chosen from CBG, CBGA and CBDV (Claim 1 of Greenway). Regarding the pharmaceutical composition, Greenway teaches that the pharmaceutical composition includes a carrier such as coconut oil (paragraph 0053). Moreover, Greenway teaches a method of treating inflammation and/or autoimmunity in a subject comprising administering the composition, wherein the autoimmunity condition includes, but is not limited to, rheumatoid arthritis or Crohn’s disease (Claims 41 and 43 of Greenway). Regarding the administration, Greenway teaches that the pharmaceutical composition is administered orally as a medication, nutritional supplement or a food additive (paragraph 0067).
Greenway does not specifically teach that the composition further comprises a terpene such as terpinolene or optimization of the amounts of terpinolene.
Kim et al. teach that terpinolene has been shown to attenuate inflammation and oxidative stress in vitro by significantly inhibiting NO and superoxide production in a macrophage cell-culture-based assay (page 16 of 32, paragraph bridging 15 or 32).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to add a terpene such as terpinolene and optimize the amounts of the cannabinoids/terpene in the composition taught by Greenway in view of the teachings of Kim et al.. One of ordinary skill in the art would have been motivated to make such a modification, with a reasonable expectation of success, because:
-Kim teaches that terpinolene contains anti-inflammatory properties.
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[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).
Moreover, "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
Conclusion
Therefore, No claim is allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Russo, Ethan (British Journal of Pharmacology (2011) 163 1344-1364).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRANDON J FETTEROLF whose telephone number is (571)272-2919. The examiner can normally be reached M-F 6AM-4PM.
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, Joseph McKane can be reached at 571-272-0699. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
BRANDON J. FETTEROLF
Primary Patent Examiner
Art Unit 1626
/BRANDON J FETTEROLF/ Primary Examiner, Art Unit 1626