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
Status of the claims
Claims 1-2 and 4-6 are pending and are examined herein.
All rejections of claims 3, 7-8 are moot in light of Applicant’s cancellation of those claims.
The rejection of claims 1-2 and 4-6 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(or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention, has been partially withdrawn in light of Applicant’s amendment of the claims. Please see below for the remaining ground(s) of rejection under 35 U.S.C. 112(b).
The rejection of claim 1 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement is withdrawn in light of Applicant’s amendment of the claims.
The rejection of claims 1-4 under 35 U.S.C. 102(a)(1) as being anticipated by “L’Orange”, taken with the evidence of the instant specification, is withdrawn in light of Applicant’s amendment of the claims.
The rejection of claims 5-8 under 35 U.S.C. 103 as being unpatentable over “L’Oragne”, in view of Poyatos et al (2020, Medicina 56: 309, pages 1-21) taken with the evidence of the instant specification, is withdrawn in light of Applicant’s amendment of the claims.
Claim Objections
Claims 1 and 6 are objected to because of the following informalities: the claims recite that a representative sample of seed of “LO2013” is deposited under accession number “________”. These deposit accession numbers are not complete and cannot be used to access the deposited seeds.
Claim 6 is objected to because the claim appears to be lacking the text describing the limitations drawn to a cannabinoid profile and terpene profile.
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 1-2 and 4-6 remain 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. All dependent claims are included in the rejections set forth below unless indicated otherwise. Due to Applicant' s amendment of the claims, the rejection is modified from the rejection set forth in the previous Office action. Applicant’s amendments filed 5 February 2026 have been full considered but they are not persuasive as they apply to the maintained rejection.
Claims 1 and 6 are indefinite in the recitation of " a Cannabis plant designated ‘LO2013’ wherein a representative sample of seed of said plant has been deposited under ______________" because the deposit accession information is missing. Because the claims are not currently tied to any deposits with valid accession numbers, the metes and bounds of said claims are not clear.
Claim 6 is indefinite because it on line 6 it recites “a cannabinoid profile of:” and “a terpene profile of:” but does not recite any values for said profiles. Thus the metes and bounds of claim 6 are not clear.
Response to Applicant’s remarks filed 5 Feb 2026:
Applicant has not made any arguments drawn to the rejection of claims 1-8 as being indefinite for failing to recite a valid deposit accession number. The claims have not been amended to recited a valid deposit accession number. Applicant has not perfected a seed deposit of “LO2013”. For these reasons, the claims remain rejected.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Enablement
Claims 1-2 and 4-6 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. The rejection is repeated for the reasons of record as set forth in the previous Office action. Applicant’s amendments filed 5 February 2026 have been full considered but they are not persuasive.
The invention appears to employ novel plants. Since the seeds claimed are essential to the claimed invention, they must be obtainable by a repeatable method set forth in the specification or otherwise be readily available to the public. If a seed is not so obtainable or available, a deposit thereof may satisfy the requirements of 35 U.S.C. 112. The specification does not disclose a repeatable process to obtain the exact same seeds in each occurrence and it is not apparent if such a seed is readily available to the public. It is noted that Applicant asserts that a deposit of representative seeds of the instant variety will be made but the deposits lack any identifying deposit numbers and does not appear to have been made yet (¶0021; ¶0037-0038).
If the deposit of these seeds is made under the terms of the Budapest Treaty, then an affidavit or declaration by the Applicant, or a statement by an attorney of record over his or her signature and registration number, stating that the seeds will be irrevocably and without restriction or condition released to the public upon the issuance of a patent would satisfy the deposit requirement made herein. A minimum deposit of 625 seeds is considered sufficient in the ordinary case to assure availability through the period for which a deposit must be maintained.
If the deposit has not been made under the Budapest Treaty, then in order to certify that the deposit, meets the requirements set forth in 37 CFR 1.801-1.809, Applicant may provide assurance of compliance by an affidavit or declaration, or by a statement by an attorney of record over his or her signature and registration number showing that
(a) During the pendency of the application, access to the invention will be afforded to the Commissioner upon request;
(b) All restrictions upon availability to the public will be irrevocably removed upon granting of the patent;
(c) The deposit will be maintained in a public depository for a period of 30 years or 5 years after the last request or for the enforceable life of the patent, whichever is longer; and
(d) Evidence will be provided of the test of the viability of the biological material at the time of deposit (see 37 CFR 1.807).
In addition, the identifying information set forth in 37 CFR 1.809(d) should be added to the specification. See 37 CFR 1.801 - 1.809 [MPEP 2401-2411.05] for additional explanation of these requirements.
Response to Applicant’s Arguments filed 5 February 2026:
Applicant requests that the rejection be held in abeyance pending resolution of other rejections and objections.
The rejection is maintained.
Written Description
Claims 2 and 4-6 remain rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Due to Applicant' s amendment of the claims, the rejection is modified from the rejection set forth in the previous Office action. Applicant’s amendments filed 5 February 2026 have been full considered but they are not persuasive.
Applicant claims a living cannabis plant, plant part, tissue, or cell thereof, produced by growing the seed of claim 1, or a first generation or second generation descendent thereof, wherein flower produced from the cannabis plant comprises the cannabinoid profile and terpene profile set forth in claim 2 (and claim 6). Examiner interprets “the cannabis plant” on line 3 or claim 2 to encompass said descendent and thus the descendent is likewise required to have said cannabinoid and terpene profile.
Thus, the plant of claim 2 encompasses a plant that is the progeny of an F1 hybrid of “LO2013” (which is a hybrid itself) and a second plant, crossed with a third plant . Such a progeny would result in numerous recombination events and result in a population of progeny which segregate for all the traits present in the parental varieties.
Regarding claim 6, there are no limitations drawn to how the descendent is generated or how many generations removed from the “LO2013” said descendent is. Thus, a “descendent” as claimed by Applicant, would encompass, for example, a descendent plant generated by initially crossing the plant grown from the seed of claim 1 with a different cannabis plant, and then further crossing the initial progeny plant with a different cannabis plant for each of an additional 10 generations. Such a descendent would have very little genetic or phenotypic similarity to the “LO2013”. Further, as there are no limits regarding how such a descendent is produced, a descendent would encompass any plant with even the most distant relationship to the plant grown from the seed of claim “LO2013”. Furthermore, claim 6 recites, on lines 5 “growing a seed or clone from a Cannabis plant designated ‘LO2013’, wherein a representative sample of seed of said plant has been deposited…”. The seed is thus interpreted to encompass an F1 hybrid between “LO2013” and another Cannabis plant as well as a seed produced by selfing “LO2013” because a seed “from” a plant (as opposed to “a seed of a plant”) encompasses seeds produced from crossing or selfing said plant. This would encompass a nearly limitless number of hybrids which would comprise an unknown and unbounded amount of genetic variation. Moreover, even if “LO2013” were selfed, it would produce F2 progeny which segregate for all the traits present in the parental varieties of “LO2013”. In either case, this represents a vast genus of plants. Examiner notes that here that no cannabinoid or terpene profile is recited in step b, as explained above in the rejection of claim 6 under 35 U.S.C. 112(b).
Applicant further claims a living cannabis plant descended from claim , wherein the descendent is a clonal descendent. However, there are no limitations regarding which generation the clonal descendant is derived from nor are there any limitations which preclude said clonal descendent being derived from a sexually produced descendent of “LO2013”, thus, said claimed plant encompasses the same vast and variable genus described above.
Applicant has described a single Cannabis plant, “LO2013” (see paragraphs 0011, 0013-0015, Tables 1 and 2).
Applicant has not described any other Cannabis plants , nor any F1 or F2 hybrids, nor any first generation or second generation descendants, wherein flower produced from the plant comprises the cannabinoid profile and terpene profile set forth in claims 2 or 6.
Applicant has not described any structural features that distinguish plants descended from Cannabis plant “LO2013”, or F1 hybrids of “LO2013”, from other Cannabis plants.
Regarding the cannabinoid and terpene profiles, the claimed characteristics appear to be partly or wholly functional, rather than structural. Applicant states that the values represented in Tables 1 and 2 are “merely exemplary” and include “predicted normal variations of observed values” and that due to the natural variability of chemotypic expression in Cannabis for “various reasons”, the values do not represent the only possible range of outcomes ((¶0024 and (¶0032). Applicant provides no upper or lower bounds for these values—they seem to be almost completely open-ended. Thus, it appears there is not a strong correlation between genotype and phenotype. In other words, they are simply the function of the genetic characteristics of the plant in response to the environment or some other variable present in the location in which the plant was grown. However, functional characteristics that are subject to change based on environment or other “various reasons” cannot serve as the basis to describe the invariable structural features common to members of the claimed genus.
These undescribed and possibly unknown effects mean that a plant of a given genotype may have the claimed phenotype(s) when grown under certain conditions and not under others, and that a plant of a given genotype would be encompassed by the claims when grown under certain conditions and not when grown under others. Thus, the public would not know when they are infringing or when they might infringe the claimed plants.
Because the phenotypic manifestations of the gene(s) that confer this trait are affected by these conditions, the gene(s) (i.e., structures) that confer these traits must be described. They are not. The structural features that distinguish Cannabis plants with the gene(s) that confer the claimed cannabinoid profile and terpene profile from other Cannabis plants are not described in the specification.
Applicant does not describe the genus of plants as broadly claimed. The single described embodiment is not representative of the breadth of the claimed genus (which encompasses a vast number of undescribed plants descended and derived from “LO2013” with apparently any combination of described and undescribed cannabinoid and terpene levels), and applicant has not provided an adequate description of the structure-function relationship such that one of ordinary skill in the art would be able to envision which Cannabis plants are members of the claimed genus and which are not. Therefore, Applicant does not appear to have been in possession of the claimed genus of Cannabis plants at the time this application was filed.
Response to Applicant’s Arguments filed 5 February 2026:
On pages 8-9, Applicant argues that the claim amendments to limit claim 2 to a first or second generation descendent of a plant grown from the deposited seed, and the claim amendments to limit claim 6 to a clonal descendent of the seed of claim 1 sufficiently narrow the claims to overcome the written description.
Applicant further argues that a seed deposit, to be made at a later date, will adequately show possession of the invention as currently claimed.
Applicant argues that claim 2 is not indefinite because the claimed ranges of cannabinoid and terpene levels are a subset of possible embodiments and said ranges set the metes and bounds of claim 2.
This is not found persuasive.
As set forth above, the genus of claimed plants still encompasses and unknown and unbounded amount of genetic variation relative to the one described species, ‘LO2013’. Furthermore, despite Applicant’s statement to the contrary, Applicant has not amended claim 6 to claim a clonal descendent of the seed of claim 1. It is not clear how a deposit of ‘LO2013’, which is defined by both its genotype (breeding history) and phenotype (traits) would be representative of this vast and variable genus that encompasses plants with a great deal of variation in genotype and phenotype relative to the deposited seed. Furthermore, a deposit is not a substitute for a written description of the claimed invention.
Regarding Applicant’s arguments drawn to the indefiniteness of claim 2, these are not considered here as claim 2 has been rejected under 35 U.S.C. 112(a) as set forth above. However, the Examiner notes that a claim scope which is not indefinite is not necessarily adequately described by the disclosures of the specification.
For these reasons, the rejection is maintained.
Subject Matter Free of the Prior Art
Claims 1-2 and 4-6 appear to be free of the prior art. The closest prior art is “L’Orange”, https://www.cannabiotix.com/flower/lorange with WayBack Machine Publication date of 12 May 2021 having the link: https://web.archive.org/web/20210512183115/https://www.cannabiotix.com/flower/lorange , (hereinafter “Cannabiotix 2021”), in view of Poyatos et al (2020, Medicina 56: 309, pages 1-21) taken with the evidence of the instant specification.
Cannabiotix 2021 discloses a cannabis clone named “L’Orange” with the parentage of “Orange Crush x Lemon Burst Phenotype #37”. While applicant does not disclose any other names of “LO2013”, given the “LO” in “LO2013”, given that Cannabiotix seems to be the same entity as the Applicant (Cbiotix LLC) and given the substantially similar parentage of the plant disclosed by Cannabiotix 2021, the preponderance of evidence suggests that these two plants are “one and the same”. Also, by Applicant’s own admission, a plant derived from a cross of ““Orange Crush x Lemon Burst Phenotype #37” would inherently comprise the cannabinoid profile of Table 1 and terpene profile of Table 2 (¶0011 and ¶0031).
However, the amended claims are now limited to a living Cannabis plant. Furthermore, in response to a Request for Information Under 37 CFR 1.105 sent with the previous Office action (see Remarks filed 5 February 2025, pages 8-10) applicant has indicated that ‘LO2013’ was never available as living material or seed—only the dried, seedless flower and extracts thereof had been offered for sale. Furthermore, at least one of the parental lineages is a proprietary lineage and that no seeds or clones have ever been sold. Therefore, while the teachings of Cannabiotix, in view of Poyatos, would make obvious the claimed invention, they are not enabled. Living tissue or seed of the claimed variety and at least one of its parents was not available at the time of filing. Dried flower tissue could not, at the time of filing, be used to regenerate a living plant. Even if any seed were inadvertently produced and distributed with the dried flowers, said seeds would be either an F2 generation of “LO2013” if the result of selfing or a cross with a wholly different plant, and thus not the claimed variety.
For these reasons, the claims are free of the prior art.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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 ALEKSANDAR RADOSAVLJEVIC whose telephone number is (571)272-8330. The examiner can normally be reached Monday--Friday 8-5:30.
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/ALEKSANDAR RADOSAVLJEVIC/Examiner, Art Unit 1662
/BRENT T PAGE/Primary Examiner, Art Unit 1663
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