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
The instant application was filed 30 September 2022. The Applicant claims priority to provisional application 63/251,431 filed 01 October 2021. Therefore, the effective filing date of the instant application is 01 October 2021.
Examiner’s Note
The Applicant's amendments and/or arguments filed 02 January 2026 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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. In the Applicant’s response, filed 02 January 2026, it is noted that claims 8 and 15 have been amended and no new claims have been added. Support for the amendments can be found on para. 70 of the specification. No new matter has been added.
Claim Objections
Claims 8, 10, 15 and 17 are objected to because of the following informalities: The Applicant is advised to remove the unnecessary quotation marks in claims 8, 10, 15, and 17 for clarity purposes. For instance, tetrahydrocannabinolic acid (“THCA”) in claim 8 should be corrected to tetrahydrocannbinolic acid (THCA). Appropriate correction is required.
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 8 and 15 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claims 8 and 15 recite the broad recitation “cannabis biomass comprises…a cannabinoid acid compound,” and the claim also recites “cannabis biomass that is trichomes” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim Rejections - 35 USC § 112
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 9 and 16 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. Claims 9 and 16 recite “cannabis biomass further comprises,” but claims 8 and 15 recite “cannabis biomass that is trichomes,” which is interpreted as “closed” language. 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 § 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.
Claim(s) 8-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stauff (WO 2018/175796 A1).
Stauff teaches a method of producing and using cannabis extracts, which are known to contain THCA and CBDA in various amounts (entire teaching; para. 128), and is interpreted as addressing an effective therapeutic or anesthetic amount. Stauff teaches several different embodiments with different amounts of components in cannabis, such as with CBDA and THCA present, but free of CBD and/or THC (para. 129), addressing claims 8, 10, 15, and 17. The composition can further include terpenes (para. 94), different oils (para. 99), and penetration enhancers (para. 126), addressing claims 9, 11, 12, 16, and 19. The method of producing includes grinding cannabis stems and mixing with a carrier (para. 56), such as vegetable oils (para. 37), addressing claims 8, 14, 18, and 21. The composition may be in the form of a patch (para. 126) and may be used to treat pain (para. 124), which is interpreted as addressing either acute or chronic pain, addressing claim 13, 20, and 22. Stauff teaches that in some embodiments, the extract is not treated and the conversion of THCA and CBDA into THC and CBD is avoided (para. 128), which is interpreted as raw cannabis (evidenced by Applicant’s specification, para. 58), addressing claims 8 and 15. Stauff additionally teaches that the composition itself may be substantially free of THC (para. 128). The feedstock may comprise the trichome part of the Cannabis plant (para. 127), addressing the limitation in claims 8 and 15. Claims 8 and 15 recite “raw cannabis biomass that is trichomes,” which is interpreted as “closed” language. However, the claims use “comprising” or open language overall. Therefore, the claims are interpreted as “open” to additional ingredients other than trichomes.
Stauff does not teach an exact combination of THCA, CBDA, and free of THC in claims 8 and 15.
In regards to selecting the combination of THCA, CBDA, and free of THC, “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious.” KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G.Pro, 425 U.S. 273, 282 (1976)). “When the question is whether a patent claiming the combination of elements of prior art is obvious,” the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR at 1741. The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742.
Consistent with this reasoning, it would have been obvious to have selected various
combination of various disclosed ingredients from within a prior art disclosure, to arrive at compositions “yielding no more than one would expect from such an arrangement.”
Stauff teaches compositions and methods for making and using a cannabis patch product that may comprise THCA, CBDA, and terpenes, whereas the claimed invention is directed towards a method of producing a cannabis composition comprising THCA and a minor cannabinoid acid compound other than THCA. Since Stauff teaches the individual components of the claimed composition, it is obvious for one of ordinary skill in the art to select the different combinations of ingredients to arrive at the claimed invention with a reasonable expectation of success.
Response to Arguments
Applicant's arguments filed 04 June 2025 have been fully considered but they are not persuasive.
The Applicant argues that Stauff does not teach forming a composition of raw cannabis biomass wherein the cannabis is in the form of trichomes (Remarks, pg. 6).
Applicant’s argument is not found persuasive. Stauff teaches that the feedstock may comprise the trichome part of the Cannabis plant (para. 127), addressing the limitation in claims 8 and 15.
The Applicant argues that Stauff does not teach a composition that is substantially free from THCA in its decarboxylated form (Remarks, pg. 6).
Applicant’s argument is not found persuasive. The Applicant is erroneously pointing to narrow embodiments expressly disclosed within the prior art reference as representing the sum total of information conveyed by each. Art is art, not only for what it expressly teaches, but also for what it would reasonably suggest to the skilled artisan, including alternative or non-preferred embodiments (see MPEP § 2123). Stauff teaches an embodiment where the extract is not heated in order to avoid conversion of THCA and CBDA into THC and CBD (para. 58). Similarly, the Applicant’s specification describes this activation process of raw cannabis (instant specification, para. 57-58). Therefore, it is interpreted that Stauff’s teaching of an embodiment where the extract is not heat processed to avoid decarboxylation as a raw cannabis biomass.
The Applicant argues that keeping the extracting temperature below a certain degree does no itself ensure the extract is substantially free from THC (Remraks, pg. 8).
Applicant’s argument is not found persuasive. Stauff teaches that the composition itself may be substantially free of THC (para. 128).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Danielle Kim whose telephone number is (571)272-2035. The examiner can normally be reached M-F: 9-5 p.m. PST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian-Yong Kwon can be reached at (571)272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/D.A.K./Examiner, Art Unit 1613
/ANDREW S ROSENTHAL/Primary Examiner, Art Unit 1613