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 .
Declaration under 37 CFR 1.132
The Declaration under 37 CFR 1.132 filed 12 January 2026 is insufficient to overcome the rejection of claim 2 (claim 3 in the Office action mailed 17 July 2025) based upon 35 U.S.C. 112(b) as set forth in the last Office action because it has not clarified if the ranges of values are meant as claim limitations or are meant to be interpreted as “merely exemplary” due to the language in the specification. Applicant’s declaration argues that the variation in chemotypic values could be due to environmental conditions, rather than genetic variability. This is not relevant to the basis of the rejection. Examiner notes, however, that the rejection of claim 2 on this ground has been overcome by Applicant’s amendment of the claims.
Specification
The disclosure is objected to because of the following informalities: in ¶0023 the specification lists the accession number under which VB252C is deposited as “_______”. The deposit accession number needs to be specified.
Appropriate correction is required.
Status of the claims
Claims 1-2, and 4-8 are pending and are examined herein.
All rejections of claim 3 are moot in light of Applicant’s cancellation of the claims.
The rejection of claim 6 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112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement is withdrawn in light of Applicant’s amendment of the claim.
The rejection of claim 4 under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter is withdrawn in light of Applicant’s amendment of the claim.
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, and new claims 7-8 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. Due to Applicant' s amendment of the claims, the rejection is modified from the rejection set forth in the previous Office action, as applied to claims 1-6. Applicant' s arguments filed 12 January 2026 have been fully considered but they not persuasive.
Claims 1 is indefinite in the recitation of " a Cannabis plant designated ‘VB252X’ 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. Claims 2, and 4-8 depend directly or indirectly from said claims and are rejected on the same grounds as they fail to overcome the deficiencies of the parent claim.
Response to Applicant’s Arguments filed 12 January 2026:
Applicant argues, on page 5 of the Remarks, that the amendment of claim 1 overcomes the rejection because the claims no longer encompass a hybrid plant comprising VB252X as one of the parental lines. This is not found persuasive.
The issue, as set forth above and in the previous Office action, is that the claims lack a corresponding deposit number. Without the deposit number in the independent claims, it is unclear what Cannabis plant is being referred to. Common designations of plant varieties can change over time and the term “VB252X” is not otherwise known in the art. For these reasons, the rejection on this ground is maintained. Examiner notes that the other grounds of rejection under 35 U.S.C. 112(b) set forth in the previous Office action have been overcome by Applicant’s amendment of the claims.
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 remain rejected, and new claims 7-8 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, as applied to claims 1-6. Applicant' s arguments filed 12 January 2026 have been fully considered but they 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 (¶0023; ¶0048).
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 12 January 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 4-5 remain rejected, and new claims 7-8 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 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, as applied to claims 2-6. Applicant' s arguments filed 12 January 2026 have been fully considered but they not persuasive.
Applicant claims a cannabis plant, plant part, tissue, or cell thereof, produced by growing the seed of claim 1, or a first or second-generation descendent thereof wherein a flower of the plant comprises a cannabinoid profile as set forth in claim 2. Thus, the plant of claim 2 encompasses a plant that is the progeny of an F1 hybrid of VB225X 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. Claim 4 further encompasses an F1 of the plant of claim 2 and would thus encompass a plant with yet another round of recombination and further segregation of traits. Thus, Applicant’s claims are drawn to a vast and variable genus.
Applicant has described a single Cannabis plant, VB252X (see paragraphs 0011, 0013-0015, and 0039-0047).
Applicant has not described any other Cannabis plants nor any descendants thereof.
Applicant has not described any structural features that distinguish plants descended from Cannabis plant VB252X from other Cannabis plants.
Regarding the cannabinoid profiles of instant claim 2 (see Table 1), the claimed characteristics appear to be partly or wholly functional, rather than structural. Applicant states that the values represented in the table are “merely exemplary” and that due to the natural variability of chemotypic expression in Cannabis for “various reasons”, that the values do not represent the only possible range of outcomes. Applicant does not describe the various reasons paragraph 0034). 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 cannabinoid profile of Table 1 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, 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 12 January 2026:
Applicant argues, on page 7 of the Remarks, that the rejection has been overcome by limiting claims 2 and 4 to only two generations removed from a plant grown from the deposited seed, thus sufficiently narrowing the genus. Applicant further argues that a seed deposit, to be made a latter date, will adequately show possession.
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, VB225X. It is not clear how a deposit of VB225X would be representative of this vast and variable genus. Furthermore, a deposit is not a substitute for a written description of the claimed invention. For these reasons, the rejection is maintained.
Subject Matter Free of the Prior Art
Claims 1-6 appear to be free of the prior art.
The closest prior art is Lewis et al (US 11,317,577). Lewis teaches hemp cultivar ‘095101’, which shares the following trait with the instant cultivar: thick stem pith, medium seed marbling, flowering height of approximately 2 m, broadly similar THC and CBD levels, petiole anthocyanin intensity, low proportion of hermaphrodites, and average productivity. They differ, however, in parental genetics and as well the following traits: time to flowering, seed shape, petiole length, depth of stem grooves, width of central leaflet, and length of central leaflet.
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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