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 .
Reassignment of Application
Please note that this application has been reassigned to Examiner Ibrahim Bori, in Art Unit 1629. In order to expedite accurate processing of the application papers, all future correspondence with the office should reflect this change.
Status of the Claims
Claims 6-7, 10, 13-26, 33, 39 and 44 are pending.
Applicants’ arguments filed on 11/25/2025, 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 Rejections and/or objections not reiterated from previous Office actions are hereby withdrawn.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 of rejections and/or objections presently being applied to the instant application.
Applicants’ amendments filed on 11/25/2025, have been fully considered. Applicants have amended claims 10, 13-14, 16-17, 19, 21, 25, 33, 39 and 44. Therefore, claims 6-7, 10, 13-26, 33, 39 and 44 are subject of the Office action below.
Withdrawn Rejections:
The rejection of claims 6-7, 10, 13-26, 33, 39 and 44 under 35 U.S.C. 101, is overcome by the Applicant’s arguments and is hereby withdrawn. For example, Applicant argues on the grounds that the rejection failed to identify tricyclohumuladiol III as naturally occurring (see page 2 of Remarks and ¶s 39-40 of the declaration of C. Russel Thomas, filed on 11/25/2025).
The rejection of claims 6-7, 10, 13-26, 33, 39 and 44 under 35 U.S.C. 102(a)(2) as being anticipated by US Pub. No. 20200048214 (‘US214) of record, as evidenced by Applicant’s disclosure, is overcome by the Applicant’s arguments and is hereby withdrawn. For example, Applicant argues on the grounds that the subject matter disclosed in the ‘US214 and the claimed invention, not later than the effective filing date of the claimed invention, were subject to an obligation of assignment to the same person. Please see page 3 of Remarks and ¶s 47-49 of the declaration of C. Russel Thomas, filed on 11/25/2025.
The rejection of claims 6-7, 10, 13-26, 33, 39 and 44 under 35 U.S.C. 103 as being unpatentable over as being unpatentable over WO2017192527A1 of record in view of WO2017168422A1 of record and Nagy et al of record and as evidenced by Applicant’s disclosure, is overcome by the Applicant’s arguments and is hereby withdrawn. For example, Applicant argues on the grounds that none of the cited references suggest or teach vapor-phase decarboxylation (see pages 3-5 of Remarks).
The rejection of claims 6-7, 10, 13-26, 33, 39 and 44 on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 10,669,248, is overcome by the Applicant’s arguments and is hereby withdrawn. For example, Applicant argues on the grounds that practicing the method claims of the ‘248 patent will not result in a composition of the instant claims (see pages 6-7 of Remarks and ¶s 78-92 of the declaration of C. Russel Thomas).
In view of the withdrawal of the previous office action (see discussions above), a second Non-Final Office action is being issued below.
Claim Rejections - 35 USC § 112-4th Paragraph
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 7 and 39 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Each of claims 7 and 39 recites: i) tetrahydrocannabinol (THC, claim 7); and ii) (6aR,10aR)-6,6,9-trimethyl-3-pentyl-6a,7,8,10a-tetrahydro-6H-benzo[c]chromen-1-ol (claim 39, i.e., THC, see page 10 of WO2020123383A1, incorporated by reference on page 2 of the instant specification), which does not appear to further limit claim 6 from which claims 7 and 39 depend. This is because claim 6 recites THC.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 6-7, 10, 13-26, 33, 39 and 44 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.
Making reference to the Interim Guidance for Subject Matter Eligibility Analysis of Process Claims Involving Laws of Nature in view of Mayo Collaborative Services v. Prometheus Laboratories, Inc. 566U.S._132 S.Ct. 1289, 101 USPQ2d 1961 (2012), the Supreme Court made clear that claims that do nothing significantly more than simply describing natural relations are not patentable. For instance, the Supreme Court stated:
“If a law of nature is not patentable, then neither is a process reciting a law of nature, unless that process has additional features that provide practical assurance that the process is more than a drafting effort designed to monopolize the law of nature itself. A patent, for example, could not simply recite a law of nature and then add the instruction "apply the law." Einstein, we assume, could not have patented his famous law by claiming a process consisting of simply telling linear accelerator operators to refer to the law to determine how much energy an amount of mass has produced (or vice versa). Nor could Archimedes have secured a patent for his famous principle of flotation by claiming a process consisting of simply telling boat builders to refer to that principle in order to determine whether an object will float…
To put the matter more succinctly, the claims inform a relevant audience about certain laws of nature; any additional steps consist of well understood, routine, conventional activity already engaged in by the scientific community; and those steps, when viewed as a whole, add nothing significant beyond the sum of their parts taken separately. For these reasons we believe that the steps are not sufficient to transform unpatentable natural correlations into patentable applications of those regularities.”
In the instant case, the claims are held to be directed to a law of nature, a natural phenomenon, or naturally occurring relation or correlation without significantly more, and are therefore rejected as ineligible subject matter under 35 U.S.C. 101. The rationale for this finding is explained below:
The claim(s) recite(s) a cannabinoid and terpene composition comprising tetrahydrocannabinol (THC), β-caryophyllene, caryophyllene oxide, humulene, and humulene epoxide II. Based upon an analysis with respect to the claims as a whole, claim 6 is determined to be directed to a law of nature/natural principle. The rationale for this determination is explained below.
1) Is the claimed invention directed to at least one of the four statutory categories (process, machine, manufacture or composition of matter)?
Claim 6 is directed to a cannabinoid and terpene composition comprising THC, β-caryophyllene, caryophyllene oxide, humulene, and humulene epoxide II.
Claim 7 depends from claim 6 and further recites cannabigerol (CBG), cannabidiol (CBD), THC and cannabichromene (CBC).
Claim 10, 39 depend from claim 6 and further recites tetrahydrocannabivarin (THCV).
Claims 14, 17 depends from claim 6 and further recite humulene epoxide I and III.
Claim 19 depends from claim 6 and further recites bicyclohumuladiol.
Claim 21 depends from claim 6 and further recites tricyclohumuladiol.
Claim 23 depends from claim 6 and further recites tricyclohumuladiol II.
Claim 25 depends from claim 6 and further recites humulenol II.
As such, the condition for the first inquiry is met.
2A) Does the claim recite or involve a judicial exception (Abstract Ideas, Laws of Nature/Natural Principles, Natural Phenomena or Natural Products)?
All of the recited cannabinoid and terpene compounds are naturally occurring and therefore the claims are directed to a mixture of naturally occurring cannabinoid and terpene compounds. For example:
1) Namdar et al (hereinafter “Namdar”, Industrial Crops & Products, 2018, 113, 376-382), provides evidence of naturally occurring THC, β-caryophyllene, caryophyllene oxide, humulene, CBG, CBD and CBC (see abstract and Table 1).
2) Schleider of record (WO2017168422A1), provides evidence of naturally occurring THC, CBG, CBD, CBC, THCV, β-caryophyllene, caryophyllene oxide, humulene and humulene epoxide II (see Table 2 and pages 41-44).
3) Arceusz et al (hereinafter “Arceusz”, J. Sep. Sci., 2013, 36, 3130-3134), provides evidence of naturally occurring caryophyllene oxide, humulene epoxide I, humulene epoxide II and humulene epoxide III (see abstract and Table 1).
4) Xu et al (hereinafter “Xu”, J. Nat. Prod., 2004, 67(4), 569-576), provides evidence of naturally occurring (see abstract and page 569), bicyclohumuladiol (compound 14, see page 570, Chart 1) and tricyclohumuladiol (compound 13, see page 570, Chart 1). Compound 14 structure reads on the bicyclohumuladiol structure recited on page 8 of WO2020123383A1, incorporated by reference on page 2 of the instant specification.
5) Yin et al (hereinafter “Yin”, Planta Med., 2005, 71, 979-982), provides evidence of naturally occurring (see abstract), tricyclohumuladiol II (compound 7, see page 980, Figure 1). Compound 7 structure reads on the tricyclohumuladiol II structure recited on page 9 of WO2020123383A1, incorporated by reference on page 2 of the instant specification.
6) Peacock et al (hereinafter “Peacock”, JASBC., 1981, 39(4), 136-141), provides evidence of naturally occurring caryophyllene, humulene, humulene epoxide I, humulene epoxide II, humulene epoxide III and humulenol II (see Table 1).
As such, the condition for the second inquiry is met.
2B) Does the claim include additional elements/steps or a combination of elements/step that integrate the natural principle into the claimed invention such that the natural principle is practically applied, and are sufficient to ensure that the claim amounts to significantly more than the natural principle itself? (Is it more than a law of nature plus the general instruction to simply “apply it”?).
No. This is because the claimed naturally occurring cannabinoid and terpene compounds are not markedly different from their naturally occurring counterparts, i.e., the individual naturally occurring compounds or their natural presence together. There is no indication on the record that the mixture has any characteristics that are different from the naturally occurring compounds or their natural presence together. For example, the structures of each of THC, β-caryophyllene, caryophyllene oxide, humulene, and humulene epoxide II (claim 6), in the mixture has not been changed by their aggregation into a mixture and each compound in the mixture continues to have the same physical and/or biological properties it has individually. This judicial exception is not integrated into a practical application because the claims do not apply the claimed composition to any application. Rather, the claims are directed to the judicial exception itself. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the only additional element recited in the claims are the ratios of THC to the other recited compounds. However, this additional element is not sufficient to amount to significantly more than the judicial exception because these ratios appear to be naturally occurring ratios based on the isolation method employed. For example, Namdar (see Table 1), teaches that extraction using ethanol, hexane or hexane:ethanol mixture, resulted in different amounts of extracted components and having broad ratios of, for example, THC:β-caryophyllene (5:1), THC:caryophyllene oxide (51:1) and THC:humulene (17:1). However, even if these ratios are not naturally occurring, the mere aggregation of naturally occurring compounds in a solvent (e.g., ethanol, see claim 33), does not change the structure of the naturally occurring compounds in the solvent (e.g., ethanol).
Response to Applicants’ Arguments
Applicant’s arguments (see page 2 of Remarks and ¶s 15-46 of the declaration of C. Russel Thomas), alleging that the claimed cannabinoid and terpene compounds are not naturally occurring, have been fully considered but they are not found to be persuasive. This is because the arts of record provide evidence that all of the claimed cannabinoid and terpene compounds are naturally occurring (see discussions above).
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.
Claims 6-7, 10, 13-26, 33, 39 and 44 are rejected under 35 U.S.C. 103 as being unpatentable over Schleider of record (WO2017168422A1) in view of: 1) Namdar (Industrial Crops & Products, 2018, 113, 376-382); 2) Arceusz (J. Sep. Sci., 2013, 36, 3130-3134); 3) Xu (J. Nat. Prod., 2004, 67(4), 569-576); 4) Yin (Planta Med., 2005, 71, 979-982); and 5) Peacock (JASBC., 1981, 39(4), 136-141).
By way of a background, Applicant’s invention is drawn to a composition that can comprise cannabinoid and terpene compounds, having broad ratios (see pages 1-9 of the specification). A review of the specification fails to reveal any working example of a composition. Based on the Applicant’s plan for obtaining a desired result, Applicant is now claiming to have invented a cannabinoid and terpene composition comprising THC, β-caryophyllene, caryophyllene oxide, humulene, and humulene epoxide II, having broad ratios of THC to β-caryophyllene (1:1 to 500:1), caryophyllene oxide (10:1 to 5,000:1), humulene (1:1 to 500:1), and humulene epoxide II (10:1 to 5,000:1) by mass.
Specifically, independent claim 6 recites:
PNG
media_image1.png
271
616
media_image1.png
Greyscale
Dependent claims 7, 10, 14, 16-17, 19, 21, 23 and 25, further recite cannabigerol (CBG), cannabidiol (CBD), cannabichromene (CBC), tetrahydrocannabivarin (THCV), humulene epoxide I, humulene epoxide III, bicyclohumuladiol, tricyclohumuladiol, tricyclohumuladiol II and humulenol II.
Regarding claims 6-7, 10, 14, 16-17, 19, 21, 23 and 25, Schleider teaches cannabis extracts comprising varying amounts of cannabinoids and terpenes including but not limited to THC, CBG, CBD, CBC, THCV, β-caryophyllene, caryophyllene oxide, humulene and humulene epoxide II (see, e.g., Example 1, Tables 2-3, pages 41-44, page 47-48 and 55-56). Cannabis extracts have been known to exhibit utility in the treatment of various human disorders (see page 1). Schleider relates to a composition comprising at least one cannabinoid and at least one terpene for use in a method for treating, alleviating or reducing human disorders (see reference claim 1, abstract, pages 10 and 19). The cannabinoids and terpenes were extracted using organic solvents such as ethanol, hexane or carbon dioxide (addressing solvent limitation of claim 33, see Example 1).
Accordingly, at the time of the instant invention, one skilled in the art would have understood that Schleider contemplates a composition comprising at least one cannabinoid and at least one terpene, including but not limited to THC, CBG, CBD, CBC, THCV, β-caryophyllene, caryophyllene oxide, humulene and humulene epoxide II, for use in a method for treating, alleviating or reducing human disorders. A person skilled in the would have envisaged a composition comprising at least one cannabinoid and at least one terpene, including but not limited to THC, CBG, CBD, CBC, THCV, β-caryophyllene, caryophyllene oxide, humulene and humulene epoxide II, for use in a method for treating, alleviating or reducing human disorders, from the disclosure of Schleider.
Schleider differs from the claimed invention only insofar as Schleider is not explicit in teaching:
i) a composition comprising cannabinoid and terpene compounds, having broad ratios of, for example, THC:β-caryophyllene (1:1 to 500:1); and
ii) humulene epoxide I, humulene epoxide III, bicyclohumuladiol, tricyclohumuladiol, tricyclohumuladiol II and humulenol.
However, the claimed invention would have been obvious over Schleider, because at the time of the instant invention:
i) a composition comprising cannabinoid and terpene compounds, having broad ratios within the limitation of, for example, THC to β-caryophyllene (1:1 to 500:1), was known in the art; and
ii) terpenes such as humulene epoxide I, humulene epoxide III, bicyclohumuladiol, tricyclohumuladiol, tricyclohumuladiol II and humulenol, were known in the art.
For example:
1) Namdar teaches a cannabinoid and terpene composition comprising THC, β-caryophyllene, caryophyllene oxide, humulene, CBG, CBD and CBC, from C. sativa and having broad ratios of, for example, THC:β-caryophyllene (5:1), THC: caryophyllene oxide (51:1) and THC:humulene (17:1). Please see abstract and Table 1. Similar to Schleider (see discussions above), Namdar discloses that C. sativa is routinely used to treat patients with various medical conditions (see abstract and page 376).
2) Arceusz teaches terpene compounds such as caryophyllene oxide, humulene epoxide I, humulene epoxide II and humulene epoxide III, from S. officinalis (see abstract and Table 1). Similar to Schleider and Namdar (see discussions above), Arceusz discloses that S. officinalis has been largely cultivated for medicinal purposes (see page 3130).
3) Xu teaches terpenes such as bicyclohumuladiol (compound 14, see page 570, Chart 1) and tricyclohumuladiol (compound 13, see page 570, Chart 1), from C. longus (see abstract and page 569). Compound 14 structure reads on the bicyclohumuladiol structure recited on page 8 of WO2020123383A1, incorporated by reference on page 2 of the instant specification. Similar to Schleider, Namdar and Arceusz (see discussions above), Xu discloses that C. longus has been used for medicinal purposes (see page 569).
4) Yin teaches terpenes such as tricyclohumuladiol II (compound 7, see page 980, Figure 1), extracted from E. ebracteolate using ethanol and ethyl acetate (see, e.g., abstract and page 979). Compound 7 structure reads on the tricyclohumuladiol II structure recited on page 9 of WO2020123383A1, incorporated by reference on page 2 of the instant specification. Similar to Schleider, Namdar, Arceusz and Xu (see discussions above), Yin discloses that E. ebracteolata has been used for medicinal purposes (see page 979).
5) Peacock teaches terpenes such as caryophyllene, humulene, humulene epoxide I, humulene epoxide II, humulene epoxide III and humulenol II (see Table 1), from hop (see abstract.
Therefore, at the time of the instant invention, one skilled in the would have envisaged a composition comprising cannabinoid and terpene compounds of the claimed invention and having a cannabinoid:terpene ratio of, for example, THC:β-caryophyllene (5:1), THC: caryophyllene oxide (51:1) and THC:humulene (17:1), from the disclosures of Schleider, Namdar, Arceusz, Xu, Yu and Peacock. A person skilled in the art would have contemplated formulating the composition in an organic solvent (e.g., ethanol), cannabinoids and terpenes are soluble in organic compounds (see discussions above).
Furthermore, the claimed cannabinoid:terpene ratio of, for example, THC:β-caryophyllene (1:1 to 500:1), is a result effective variable that would have been routinely determined and optimized in the art, following the guidelines set forth in the prior art disclosure. For example, Namdar (see Table 1), teaches that extraction using ethanol, hexane or hexane:ethanol mixture, resulted in different amounts of extracted components and having broad ratios of, for example, THC:β-caryophyllene (5:1), THC:caryophyllene oxide (51:1) and THC:humulene (17:1). Please see discussions above.
Furthermore, MPEP § 2144.05(II)(B), states that “after KSR, the presence of a known result-effective variable would be one, but not the only, motivation for a person of ordinary skill in the art to experiment to reach another workable product or process.”
It is noted that no criticality has been demonstrated in the specification with regard to the claimed cannabinoid:terpene ratio of, for example, THC:β-caryophyllene (1:1 to 500:1).
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a). From the teachings of the reference, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Thus, the claims fail to patentably distinguish over the state of the art as represented by the cited references.
Conclusions
No claim is allowable.
If Applicants should amend the claims, a complete and responsive reply will clearly identify where support can be found in the disclosure for each amendment. Applicants should point to the page and line numbers of the application corresponding to each amendment, and provide any statements that might help to identify support for the claimed invention (e.g., if the amendment is not supported in ipsis verbis, clarification on the record may be helpful). Should the Applicants present new claims, Applicants should clearly identify where support can be found in the disclosure.
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
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to IBRAHIM D BORI whose telephone number is (571)270-7020. The examiner can normally be reached on Monday through Friday 8:00AM-5:00PM(EST).
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JEFFREY S LUNDGREN can be reached on 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/IBRAHIM D BORI/
Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629
Prosecution Insights