DETAILED ACTION
This office action is in response to applicant’s filing dated December 8, 2025.
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 .
Status of Claims
Claims 1-10, 12, 18-24, 27, and 28 are pending in the instant application. Acknowledgement is made of Applicant's remarks filed December 8, 2025. Claims 11, 13-17, 25, 26, and 29-35 were previously canceled.
Election/Restrictions
Applicant’s election of Group I, claims 1-10, drawn to a pharmaceutical composition comprising a cannabinoid and a terpene, wherein the cannabinoid is enriched for cannabidiol (CBD) and A-9-tetrahydrocannabinol (THC), or pharmaceutically acceptable salts thereof, and wherein the terpene is enriched for linalool, or a pharmaceutically acceptable salt thereof in the reply filed on December 8, 2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Applicant noted that claim 12 was not included but remains pending. The Examiner notes that claim 12 was inadvertently omitted but reads on the invention of Group I and thus is encompassed by Group I.
Claims 18-24, 27, and 28 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on December 8, 2025.
Claims 1-10 and 12 are presently under examination.
Priority
The present application is a 371 of PCT/AU2021/051454 filed on December 6, 2021, which claims benefit of foreign priority to AUSTRALIA 2020904491 filed on December 4, 2020.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on July 22, 2024 and December 8, 2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner, except where marked with a strikethrough.
Drawings
Acknowledgement is made of the drawings received on June 2, 2023. These drawings are accepted.
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 1-10 and 12 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. Claims 1-10 and 12 are directed to a pharmaceutical composition comprising a cannabinoid and a terpene, wherein the cannabinoid is enriched for cannabidiol (CBD) and A-9-tetrahydrocannabinol (THC), or pharmaceutically acceptable salts thereof, and wherein the terpene is enriched for linalool, or a pharmaceutically acceptable salt thereof. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
The analysis has been conducted in accordance with the most recent 2014 Interim Guidelines for Subject Matter Eligibility, published by USPTO in the Federal Register on 12/16/2014, http://www.gpo.gov/fdsys/pkg/FR-2014-12-16/pdf/2014-29414.pdf. See information about the Interim Guidelines at http://www.uspto.gov/patents/law/exam/interim_guidance_subject_matter_eligibility.jsp.
Based upon an analysis with respect to the claims as a whole, claims 1-10 and 12 are directed to a judicial exception (i.e., law of nature, a natural phenomenon, or an abstract idea) without significantly more. Claims 1-10 and 12 recite compositions comprising natural products and as such are directed towards a law of nature and a natural phenomenon. The claimed composition does not have markedly different characteristics from what occurs in nature, and are a “product of nature” exception. Further, the claims do not include any additional elements that are sufficient to amount to significantly more than the judicial exceptions.
The rationale for this determination is explained below:
Step 1: Is the claim to a process, machine, manufacture or composition of matter?
The elected subject matter, within the scope of the instant claims is construed as a composition comprising: cannabidiol, [Symbol font/0x44]-tetrahydrocannabinol, and linalool.
So the answer to Step 1 is: Yes, the claims are drawn to a composition of matter.
Step 2A: Is the claim directed to a law of nature, a natural phenomenon, or an abstract idea?
The claimed subject matter appears to describe a composition comprising a cannabidiol, [Symbol font/0x44]-tetrahydrocannabinol, and linalool.
Because each compound is naturally occurring, each compound or their combination together in a composition is considered a “product of nature,” which falls within each of the categories: “laws of nature” and “natural phenomena”. Thus, the claims are drawn to judicially recognized exceptions. See p74623, left column, of the Federal Registry notice: …Courts have held that naturally occurring products and some man-made products that are essentially no different from a naturally occurring product are ‘‘products of nature’’ that fall under the laws of nature or natural phenomena exception. (Section I (3); pp. 74622-4, of the Federal Registry notice discusses Natural Products.).
The next question within step 2A is: does the nature based product show “markedly different characteristics” from any naturally occurring counterpart(s) in their natural state, based on structure, function and/or properties?
Claims 1-10 and 12 recite a composition comprising a natural product. The claimed naturally occurring components exist naturally in a human/animal body. The instant specification teaches Cannabis sativa cultivars produce [Symbol font/0x44]9-tetrahydrocannabinol (THC), being the main psychoactive component of cannabis [0003]; CBD is a cannabinoid produced by plants of the genus Cannabis [0033]; only the (-)CBD enantiomer is present in cannabis plants [0038]; and “linalool” is a monoterpene alcohol commonly found as a major volatile component of the essential oils of several aromatic plant species, e.g. Cannabis sativa [0057]. Thus, Applicant’s claimed composition is essentially directed to a composition comprising naturally occurring compounds which exist in nature in Cannabis plants.
“The markedly different characteristics analysis compares the nature-based product limitation to its naturally occurring counterpart in its natural state. When there is no naturally occurring counterpart to the nature based product, the comparison should be made to the closest naturally occurring counterpart. In the case of a nature-based combination, the closest counterpart may be the individual nature-based components that form the combination, i.e., the characteristics of the claimed nature-based combination are compared to the characteristics of the components in their natural state”.
Establishment of a marked difference cannot be based on some inherent or innate characteristic of the naturally occurring counterpart. See p. 74623, footnote 28:
“To show a marked difference, a characteristic must be changed as compared to nature, and cannot be an inherent or innate characteristic of the naturally occurring counterpart. Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 130 (1948) (‘‘[The inventor did] not create a state of inhibition or of non-inhibition in the bacteria. Their qualities are the work of nature. Those qualities are of course not patentable.’’); In re Marden, 47 F.2d 958 (CCPA 1931) (eligibility of a claim to ductile vanadium held ineligible, because the ‘‘ductility or malleability of vanadium is . . . one of its inherent characteristics and not a characteristic given to it by virtue of a new combination with other materials or which characteristic is brought about by some chemical reaction or agency which changes its inherent characteristics’’). Further, a difference in a characteristic that came about or was produced independently of any effort or influence by applicant cannot show a marked difference. Roslin, 750 F.3d at 1338 (Because ‘‘any phenotypic differences came about or were produced ‘quite independently of any effort of the patentee’ ’’ and were ‘‘uninfluenced by Roslin’s efforts’’, they ‘‘do not confer eligibility on their claimed subject matter’’ (quoting Funk Bros.)).
In the instant case, there seems to be no indication in the specification that the combination of all of the above natural products has any characteristics (structural, functional or other properties) that are different from the naturally occurring counterpart in its natural state. Thus the composition does not have markedly different characteristics from what occurs in nature, and is a “product of nature exception”.
So the answer to Step 2A is: Yes, the claims are drawn to a natural composition.
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exemption?
The claims have no additional elements (other than “purified from at least one natural source”). Because the claim does not include any additional features that could add “significant more” to the exception the answer to Step B is: No, the claims do not recite additional elements that amount significantly more than the judicial exception.
In sum, applicant’s claims are not directed to a composition that is markedly different in structure from a naturally-occurring product. Therefore, the claims are not directed to patent-eligible subject matter.
The claims do not qualify as eligible subject matter, and are properly rejected under 35 U.S.C. § 101.
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 1 and 2 are rejected under 35 U.S.C. 102(a)(1) or 102(a)(2)as being anticipated by Spirtos et al (WO 2019/165387 A1, cited in the IDS filed July 22, 2024).
Regarding claim 1, Spirtos teaches a pharmaceutical composition comprising (a) tetrahydrocannabinol (THC) and cannabidiol (CBD) in a THC:CBD ratio of from 1:1.5 to 3:1 by weight and (b) one or more terpenes (claim 1 and [0048]); wherein the one or more terpenes comprises linalool (claim 6 and [0086]).
Regarding claim 2, Spirtos teaches the pharmaceutical composition is formulated as a liquid [00128-00129]; wherein the liquid comprises citric acid [00130]. Citric acid reads on a pharmaceutically acceptable carrier.
Regarding claim 12, Spirtos teaches an embodiment of the disclosure is preferably in a liquid form and is orally administered [0037].
Thus, the teachings of Spirtos anticipate the composition of claims 1, 2, and 12.
Claims 1 and 2 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Levy et al (US 2017/0266153 A1, cited in the IDS filed July 22, 2024).
Regarding claim 1, Levy teaches a composition comprising: a first purified cannabinoid; and a compound chosen from a second purified cannabinoid, a purified terpene, a purified flavonoid, and a purified mineral (claim 1); comprising a purified terpene (claim 2). Levy teaches a composition comprising purified THC (51 g), purified CBD (10 g), and purified Linalool (0.5 g) [1934]. Levy teaches the term “THC” refers to tetrahydrocannabinol and has the following structure [0297]:
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Thus, THC reads on instantly claimed [Symbol font/0x44]-9-tetrahydrocannbinol. Levy teaches “CBD” refers to cannabidiol [0313].
Regarding claim 2, Levy teaches in one embodiment, the compositions disclosed herein are combined with a carrier oil [0733].
Thus, the teachings of Levy anticipate the composition of claims 1 and 2.
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.
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.
Claims 1-8 are rejected under 35 U.S.C. 103 as being unpatentable over Spirtos et al (WO 2019/165387 A1, cited in the IDS filed July 22, 2024).
As set forth above, Spirtos teaches a composition comprising purified THC (51 g), purified CBD (10 g), and purified Linalool (0.5 g) [1934]. Spirtos does not explicitly teach the claimed amounts of CBD, linalool, and THC.
Regarding the claimed amounts of CBD of instant claims 3, 4, and 8, Spirtos teaches the pharmaceutical composition comprises about: 1 mg, 1.5 mg, 2 mg, 2.5 mg, 3 mg, 4 mg, 5 mg, 6 mg, 7 mg, 8 mg, 9 mg, 10 mg, 11 mg, 12 mg, 13 mg, 14 mg, 15 mg, 17.5 mg, 20 mg, 22.5 mg, 25 mg, 27.5 mg, or 30 mg cannabidiol (CBD) per dose [0057].
Regarding the claimed amounts of linalool of instant claims 5 and 8, Spirtos teaches the pharmaceutical composition comprises 0.3 - 0.9 mg of linalool per dose [0086].
Regarding the claimed amounts of THC of instant claims 6, 7, and 8, Spirtos teaches the pharmaceutical compositions comprise 1-50 mg, 5-40 mg, 7.5 - 30 mg, 10 – 20 mg, or 12.5 - 17.5 mg tetrahydrocannabinol (THC) per dose [0051].
It would have been prima facie obvious to one of ordinary skill in the art to utilize the amounts of CBD, linalool and THC taught by Spirtos as a starting point for optimizing the amounts of CBD, linalool and THC utilized to formulate a composition comprising of CBD, linalool and THC to treat pain, since Spirtos teaches a composition comprising CBD, linalool and THC is useful for treating pain and because dosage and treatment regimen are result-effective variables, i.e. a variable that achieves a recognized result. Therefore, the determination of the optimum or workable dosages would have been well within the practice of routine experimentation by the skilled artisan. Furthermore, absent any evidence demonstrating a patentable difference between the compositions and the criticality of the claimed dosage range, the determination of the optimum or workable dosing regimen given the guidance of the prior art would have been generally prima facie obvious to the skilled artisan. Please see MPEP 2144.05 [R-2](II)(A) and In re Aller, 220 F. 2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). ("[W]here the general conditions of claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.").
Taken together, all this would result in the compositions of claims 3-8 with a reasonable expectation of success.
Claims 1-10 are rejected under 35 U.S.C. 103 as being unpatentable over Levy et al (US 2017/0266153 A1, cited in the IDS filed July 22, 2024).
As set forth above, Levy teaches a composition comprising purified THC (51 g), purified CBD (10 g), and purified Linalool (0.5 g) [1934]. Levy does not explicitly teach the amounts of THC, CBD, and linalool of the instant claims. However, Levy does teach in one embodiment of the compositions disclosed herein, the ratio of the first purified cannabinoid to the second purified cannabinoid to the first purified terpene is between 3:3:1 to 1:1:1 [1635] and in one embodiment of the disclosed composition, the first purified cannabinoid, the second purified cannabinoid, and the first purified terpene, together, comprise between 80-100% of the total mass of the composition [1638].
It would have been prima facie obvious to one of ordinary skill in the art to utilize the amounts and ratios of CBD, linalool and THC taught by Levy as a starting point for optimizing the amounts of CBD, linalool and THC utilized to formulate a composition comprising of CBD, linalool and THC to treat pain, since Levy teaches a composition comprising cannabinoids are useful for treating pain and because dosage and treatment regimen are result-effective variables, i.e. a variable that achieves a recognized result. Therefore, the determination of the optimum or workable dosages would have been well within the practice of routine experimentation by the skilled artisan. Furthermore, absent any evidence demonstrating a patentable difference between the compositions and the criticality of the claimed dosage range, the determination of the optimum or workable dosing regimen given the guidance of the prior art would have been generally prima facie obvious to the skilled artisan. Please see MPEP 2144.05 [R-2](II)(A) and In re Aller, 220 F. 2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). ("[W]here the general conditions of claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.").
Regarding claim 9, Levy teaches in one embodiment, the cannabinoid is made in a laboratory setting, sometimes called a synthetic cannabinoid [0292].
Taken together, all this would result in the compositions of claims 3-9 with a reasonable expectation of success.
Regarding claim 10, Levy teaches the term “CBD” refers to cannabidiol and has the following structural formula:
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Levy does not explicitly teach the CBD is the (-)CBD enantiomer.
MPEP 2144.09 states:
Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977). See also In re May, 574 F.2d 1082, 197 USPQ 601 (CCPA 1978) (stereoisomers prima facie obvious); Aventis Pharma Deutschland v. Lupin Ltd., 499 F.3d 1293, 84 USPQ2d 1197 (Fed. Cir. 2007) (5(S) stereoisomer of ramipril obvious over prior art mixture of stereoisomers of ramipril.). In the instant case, the CBD taught by Levy is a stereoisomer and is of sufficiently close structurally similarity that there is a presumed expectation that such compounds would possess similar properties.
Taken together, all this would result in the composition of claim 10 with a reasonable expectation of success.
Conclusion
Claims 1-10 and 12 are rejected.
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RAYNA B RODRIGUEZ whose telephone number is (571)272-7088. The examiner can normally be reached 8am-5:00pm, Monday - Thursday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L Clark can be reached at 571-272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Rayna Rodriguez/Primary Examiner, Art Unit 1628
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