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 .
DETAILED ACTION
Applicant’s Request for Reconsideration dated October 20, 2025 is acknowledged.
Claims 21-36 are pending.
Claims 1-20 and 37-40 are cancelled.
Claims 21, 22, 24-26, 31-33 and 36 are currently amended.
Claims 21-36 as filed on October 20, 2025 are under consideration.
This action is made FINAL.
37 CFR 1.121 – Manner of Making Amendments
With regard to claims 32 and 33, as per MPEP § 714 II C (B) all claims being currently amended must be presented with markings to indicate the changes that have been made relative to the immediate prior version. The amendments within the preambles should have been presented with markings.
Withdrawn Objections / Rejections
In view of the amendment of the abstract, all previous objections to the specification are withdrawn.
In view of the amendment of the claims, all previous claim objections are withdrawn and some of the previous claim rejections under 35 USC 112(b) are withdrawn.
Applicant’s arguments and the Declaration of Basil Adil Shaaban have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on December 2, 2025 were considered.
Specification
The amendment filed October 20, 2025 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows: the 2nd through 5th sentences of the abstract do not appear to recite material otherwise disclosed. Applicant’s citation to paragraphs [0058]-[0061] of the specification is noted but it is not seen where this passage or any other passage discloses human fat compositions, synergistic terpenes, comparative studies, cannabinoid concentrations, etc. Applicant’s Remarks suggest these new features may be disclosed within the Exhibits attached to the Declaration (e.g., human fat compositions) or may be those of the applied prior art (e.g., comparative studies).
Applicant is required to cancel the new matter in the reply to this Office Action.
Claim Objections
Claim 32 is objected to because of the following informalities: claim 32 should presumably recite, for example, “wherein the at least one classical cannabinoid is present at a concentration of at least 0.1% of the composition on a weight to weight basis and the ratio of the excipient fatty acids to the at least one classical cannabinoid is at least 3:2 on a weight to weight basis” to properly further limit claim 26. Appropriate correction is required.
Maintained Grounds of Rejection: 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 21-36 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Claim(s) 21 recite(s) a nature-based composition comprising at least one cannabinoid and palmitoleic acid in a circumscribed ratio. The compositions may further comprise palmitic acid in a circumscribed ratio and amount, oleic acid in a circumscribed ratio and amount, and terpenes in a circumscribed ratio and amount (e.g., claims 22-26, 32-35). The fatty acids may be sourced from macadamia nut oil or/and sea buckthorn oil or similes thereof (e.g., claims 27-31, 36).
Cannabinoids are often sourced from Cannabis sativa plant. These plants also comprise fatty acids inclusive of palmitoleic acid, palmitic acid and oleic acid as evidenced by Razmaite et al. “Fatty acid composition of Cannabis sativa, Linum usitatissimum and Camelina sativa seeds harvested in Lithuania for food use,” Foods 10:1902, 2021 (e.g., Tables 2, 3). Terpenes are also present within these plants as evidenced by Guy et al. (US 2010/0239693).
The judicial exception is not integrated into a practical application and the claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims encompass combinations of natural products recited at a high level of generality and there is no evidence of record that the combinations possess any new structural or functional properties, e.g., that the claimed combination is more than the sum of its parts or is markedly different than what is found in nature.
The rationale for this determination is explained below: as per the Patent Subject Matter Eligibility Guidance and MPEP 2106.04(b)-(c), nature-based products that (i) are naturally occurring or (ii) are not naturally occurring but have characteristics that are not markedly different from a naturally occurring counterpart fall within an exception (law of nature or natural phenomena). Compositions, or combinations of naturally occurring nature-based products, are not patent eligible even if the combination itself is not naturally occurring absent the presence of markedly different characteristics in structure, function and/or other properties. Non-limiting examples of markedly different characteristics include biological or pharmacological functions or activities; chemical and physical properties; phenotype; and structure and form. This conclusion finds support in Funk Brothers Seed Co. v Kalo Inoculant Co., 33 U.S. 127, 131 (1948) and is re-iterated in Myriad, 133 S.Ct. at 2117 which states that “the composition was not patent eligible because the patent holder did not alter the bacteria in any way." See also Example 30 of the Life Sciences Examples of May 6, 2016 in which man-made mixtures/combinations of natural products present in prescribed amounts/ranges are deemed ineligible under the “product of nature" exception in view of Funk Brothers and in view of Myriad.
Response to Arguments and 132 Declaration: Claim Rejections - 35 USC § 101
Applicant’s arguments and the Declaration have been fully considered but they are not persuasive.
Applicant’s citation to the specification (paragraphs [0058]-[0061]) and to Exhibits A and C regarding various intended uses of compositions as claimed and statement that compositions as claimed are human-made are noted but are unpersuasive because the future intended use of a composition does not delimit the characteristics of the product per se and because the actual claims, at broadest, merely require a combination of any cannabinoid with palmitoleic acid. Such combinations do in fact occur in nature as evidenced by Razmaite et al. as set forth in the rejection. Neither the data within the instant specification nor the data submitted within the Exhibits demonstrate that the combination of any cannabinoid with palmitoleic acid produces a product other than that expected.
Applicant’s citation to the Declaration for results with macadamia nut oil (MNO) and sea buckthorn oil (SBO) are noted but are unpersuasive because the claims require neither. Rather, the claims merely recite fatty acids derived from these oils (e.g., 27-29, 36). The alleged rapid onset time (e.g., Exhibit A) is not a characteristic of the composition per se. The alleged synergy of the terpene fraction (e.g., Exhibit B) misses the mark because terpenes are natural components of Cannabis sativa. The hypothesized mechanistic link to human fat (e.g., Exhibit C) also says nothing about the compositions per se.
Applicant’s citation to the USPTO subject matter eligibility examples also does not weigh in Applicant’s favor. The cited Pomelo Juice example is deemed eligible because the added preservative changes the functional property of the composition per se. In the instant case, there is no evidence of changes in the composition per se. The additional examples are off-point because they are deemed eligible due to structural changes which generate a property not found in the natural product. In the instant case, there are no structural changes and there is no evidence of record that the genus of compositions claimed differ from products of nature. Therefore, the rejection is properly maintained.
Maintained Grounds of Rejection / New Grounds of Rejection Necessitated by Amendment
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 32 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 pre-AIA the applicant regards as the invention.
Claim 32 recites the ratio of the excipient fatty acids to the classical cannabinoids. There is insufficient antecedent basis for “the classical cannabinoids” because either potential antecedent (e.g., the one or more of claim 32, the at least one of claim 26) encompasses more than one and it is unclear if “the classical cannabinoids” references one, more than one or all of the one or more or at least one of the potential antecedents.
Response to Arguments: Claim Rejections - 35 USC § 112(b)
Applicant’s argument that the rejection is moot in view of the amendments is noted but not found persuasive because the classical cannabinoids lacks antecedent basis. See also the new claim objection infra suggesting potential clarifying language.
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 21-24 are rejected under 35 U.S.C. 103 as being unpatentable over Donaduzzi et al. (WO 2017/045053 A1, published March 23, 2017, as evidenced by English equivalent US 2018/0264121, of record) in view of Bruheim et al. (WO 2011/067666 A1, published June 9, 2011, of record) and Aquino-Bolanos et al. “Fatty acids profile of oil from nine varieties of Macadamia nut,” International Journal of Food Properties 20(6):1262-1269, 2017, of record.
Donaduzzi teaches compositions comprising cannabinoids inclusive of cannabidiol (classical cannabinoid as defined in paragraph [00091] of the instant specification) dissolved in a concentration from 5 to 500 mg/mL in an oil (excipient) selected from inter alia sea buckthorn oil or macadamia oil (title; abstract; claims, in particular 1, 2, 4, 6-8).
Donaduzzi does not specifically teach palmitoleic acid, wherein the ratio of palmitoleic acid to cannabinoid is 1:19 to 1000:1 as required by claim 21.
Donaduzzi does not specifically teach palmitic acid, wherein the ratio of palmitic acid to cannabinoid is 1:100 to 1000:1 as required by claim 22.
Donaduzzi does not specifically teach at least 5 wt% palmitoleic acid as required by claim 23.
Donaduzzi does not specifically teach oleic acid, wherein the ratio of oleic acid to cannabinoid is 1:100 to 1000:1 as required by claim 24.
These deficiencies are made up for in the teachings of Bruheim and Aquino-Bolanos.
Bruheim teaches sea buckthorn oil contains about 30% palmitoleic acid, 30% palmitic acid and 20% oleic acid and macadamia oil comprises about 20 to 25 wt% palmitoleic acid (page 18, lines 1-6; page 20, lines 3-8). Palmitoleic acid is an omega-7 monounsaturated fatty acid (page 19, last 3 lines).
Aquino-Bolanos teaches macadamia nut oil comprises about 40 to 51% oleic acid, 24 to 36% palmitoleic acid and 8.4 to 13.1% palmitic acid (title; abstract; Table 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the cannabinoid compositions of Donaduzzi comprise palmitoleic acid when the compositions comprise an oil selected from inter alia sea buckthorn oil or macadamia oil because Bruheim teaches these oils comprise palmitoleic acid, it would have been obvious that the cannabinoid compositions of Donaduzzi also comprise palmitic acid and oleic acid when the compositions comprise sea buckthorn oil because Bruheim teaches sea buckthorn oil to comprise such, and it would have been obvious that the cannabinoid compositions of Donaduzzi also comprise palmitic acid and oleic acid when the compositions comprise macadamia oil because Aquino-Bolanos teaches macadamia nut oil to comprise such.
Regarding the ratios as required by claims 21, 22, 24 and the amount as required by claim 23, approximating oil density of about 0.9 g/mL because the density of oil is just less than that of water, the compositions of Donaduzzi comprise about (5 mg cannabinoid / mL) / (900 mg solution / mL) ~= 0.6 wt% cannabinoid to about (500 mg cannabinoid / mL ) / ( 900 mg solution / mL) ~= 55.6 wt% cannabinoid, the balance of the compositions comprising the oil. For a 1 wt% cannabinoid solution in sea buckthorn oil, the composition comprises about 1 wt% cannabinoid, about 30 wt% palmitoleic acid, about 30 wt% palmitic acid and about 20 wt% oleic acid.
Claims 21-36 are rejected under 35 U.S.C. 103 as being unpatentable over Donaduzzi et al. (WO 2017/045053 A1, published March 23, 2017, as evidenced by English equivalent US 2018/0264121, of record) in view of Bruheim et al. (WO 2011/067666 A1, published June 9, 2011, of record) and Aquino-Bolanos et al. “Fatty acids profile of oil from nine varieties of Macadamia nut,” International Journal of Food Properties 20(6):1262-1269, 2017, of record as applied to claims 21-24 above, and further in view of Guy et al. (US 2010/0239693, published September 23, 2010, of record).
The teachings of Donaduzzi, Bruheim and Aquino-Bolanos have been described supra. They render obvious the amounts, sources and ratios of cannabinoids and fatty acids as required by claims 25-36, where the “similes” of claims 30, 31 are broadly and reasonably interpreted as encompassing the natural oils per se because it is understood from the instant specification (e.g., paragraphs [00051], [00095]) that “simile” means an “analogue” having similar fatty acid profiles.
Donaduzzi further teaches the cannabinoid compositions are pharmaceutical compositions suitable for the treatment of neurological disorders, especially epilepsy (title; abstract; claims, in particular 13).
They do not teach at least one terpene or terpenoid in a concentration of at most 10 wt%, wherein the ratio of terpene or terpenoid to cannabinoid is at least 1:1000 as required by claims 25, 26.
They do not teach at least one terpene or terpenoid in a concentration of at most 10 wt%, wherein the ratio of terpene or terpenoid to cannabinoid is at least 1:2000 as required by claim 34.
These deficiencies are made up for in the teachings of Guy.
Guy teaches cannabinoid containing plant extracts as neuroprotective agents comprising a cannabinoid containing fraction comprising inter alia cannabidiol and a non-cannabinoid containing fraction comprising inter alia terpenes, wherein the ratio of the cannabinoid containing fraction to the non-cannabinoid containing fraction is between 60:40 and 90:10 (title; abstract; claims, in particular 1-5; Table 1). The compositions are suitable for treatment of inter alia epilepsy (claim 13). Guy further teaches administration of cannabinoid plant extracts is more efficacious than essentially pure cannabinoids (paragraph [0020], also [0016], [0108], [0145]-[0147]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the cannabinoid compositions of Donaduzzi to comprise cannabinoid containing plant extracts as taught by Guy comprising inter alia terpenes in a cannabinoid:terpene ratio of 60:40 to 90:10 because the administration of plant extracts is more efficacious than essentially pure cannabinoids.
Response to Arguments and 132 Declaration: Claim Rejections - 35 USC § 103
Applicant’s arguments and the Declaration have been fully considered but they are not persuasive.
Applicant’s argument at pages 6-7 of the Remarks that the prior art does not teach the claimed compositions leading to unexpected improvements is unpersuasive because the prior art need only teach that which is actually claimed. There is no evidence of record of improvements, unexpected or otherwise. See MPEP 716.
Applicant’s argument at page 7 that Donaduzzi does not teach the fatty acid profiles of oils is unpersuasive because fatty acid profile of a given oil is a property thereof. As set forth in the rejection, Donaduzzi exemplifies oily solvents inclusive of sea buckthorn oil and macadamia oil in paragraph [0034] and in claim 8. Therefore, Donaduzzi anticipates the combination of cannabinoid(s) with sea buckthorn oil or/and with macadamia oil. Bruheim and Aquino-Bolanos render obvious the fatty acid profiles of sea buckthorn oil and macadamia nut oil, respectively. This is prima facie obviousness.
Applicant’s statements at pages 7-8 citing to case law to support Applicant’s position that the applied prior art does not render obvious rapid onset as set forth in the Declaration is unpersuasive because the applied prior art renders obvious that which is actually claimed. The Declaration provides no data. The statement in paragraph 8 of the Declaration that Donaduzzi’s carriers fail is unpersuasive because Donaduzzi anticipates the usage of sea buckthorn oil or/and macadamia oil. The citation to Exhibit A does not evidence the contrary. Exhibit A appears to provide a comparison of macadamia nut oil (MNO) to MCT oil (e.g., abstract). MCT oil is not one of the oils exemplified by Donaduzzi. Exhibit A appears to be limited to THC (e.g., page 1, introduction). The apparent literature review lacks nexus with the compositions claimed as the review of focused on administration. The 12-day study also lacks nexus with the compositions claimed because the compositions claimed need not be ingested according to any protocol. And the compositions claimed are not limited to THC. In order for allegations of unexpected results to weigh against evidence supporting prima facie obviousness, the allegations inter alia must be presented as a comparison to the closest prior art and must be commensurate in scope with the claims. In the instant case, Donaduzzi anticipates the combination of cannabinoid(s) inclusive of THC (e.g., claim 4) with sea buckthorn oil or/and with macadamia oil (e.g., claim 8). Therefore, any results arising from the combination of cannabinoid(s) inclusive of THC with MNO are latent to and already possessed by Donaduzzi.
The citation to Exhibit C at page 10 of Exhibit A for a detailed comparison of fatty acids in common oils is noted but is unpersuasive because Donaduzzi anticipates the combination of cannabinoid(s) with sea buckthorn oil or/and with macadamia oil and in view of Aquino-Bolanos it is known that macadamia oil comprises about 24 to 36% palmitoleic acid.
The third advancement alleged at page 11 of Exhibit A of not having to incorporate any potentially toxic chemicals is noted but is unpersuasive because such potentially toxic chemicals are embraced by the compositions claimed.
The statement in paragraph 8 of the Declaration that Guy does not enable improved onset time with terpenes is unpersuasive because Guy renders obvious the inclusion of terpenes within cannabinoid compositions as set forth in the rejection because it is known that cannabinoids comprising terpenes are more efficacious than pure cannabinoids. The terpene study of Exhibit B appears to be limited to specific terpenes (e.g., pages 3-4) and appears to conclude that the inclusion of these specific terpenes is more efficacious (e.g., pages 4-5). Because the terpene study of Exhibit B has limited nexus with the genus of compositions claimed and because it is known that cannabinoids comprising terpenes are more efficacious than pure cannabinoids, Exhibit B does not evidence results unexpected by the art.
The statement in paragraph 11 of the Declaration that MNO is known to offer maximal dermal absorption also weighs towards the obviousness of the compositions claimed and is consistent with the fact that fatty acids inclusive of palmitoleic acid are known percutaneous absorption promotors (e.g., Taravella et al. (US 2004/017546, of record)).
Applicant’s statements at pages 8-9 citing to case law to support Applicant’s position that the proffered Exhibits evidence results which outweigh the possession by Donaduzzi of cannabinoid(s) in macadamia oil is noted but unpersuasive for at least the reasons set forth infra. Therefore, the rejections are properly maintained and made again.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALISSA PROSSER whose telephone number is (571)272-5164. The examiner can normally be reached M - Th, 10 am - 6 pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, DAVID BLANCHARD can be reached on (571)272-0827. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALISSA PROSSER/
Examiner, Art Unit 1619
/MARIANNE C SEIDEL/Primary Examiner, Art Unit 1600