Status of the Application
This Office Action is in response to the Amendment and Remarks filed 2 June 2026.
The objection to the drawings is withdrawn in view of Applicant’s amendment filed 23 March 2026.
The rejection under 35 USC 112(b) is withdrawn in view of Applicant’s response. The Examiner acknowledges Applicant’s assurances concerning perfection of a deposit of biological material. Claims 7 and 8 have been cancelled, hence any rejection thereof is now moot.
The rejection under 35 USC 103 is now moot as the rejected claims have been cancelled.
Claim Rejections - 35 USC § 112
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.
Claims 1-6 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 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.
Applicant claims a seed from a Cannabis plant designated ‘CK2015’ said plant being obtained by crossing seed parent ‘White Walker OG’ with pollen parent ‘Blue Flame OG Pheno #22’ (page 2, paragraph 0011 of the Specification), and/or a first- or second-generation descendant and extracts thereof. Applicant does not teach whether either parent is an inbred or double haploid lines, thus the Examiner presumes the parental lines themselves are outcrossed and not inbred.
Applicant teaches that Cannabis plant designated ‘CK2015’ was obtained by crossing seed parent ‘White Walker OG’ with pollen parent ‘Blue Flame OG Pheno #22’ (page 2, paragraph 0011 of the Specification). Applicant teaches that Cannabis plant designated ‘CK2015’ is asexually propagated by cuttings on page 2, paragraph 0013 of the Specification. Applicant further teaches that the cannabinoid and terpene profiles of Cannabis plant designated ‘CK2015’ is highly variable between plants as exemplified in Table 1 on page 7 and Table 2 on page 8. Hence, any seed taken from a Cannabis plant designated ‘CK2015’ would be widely variable and highly genetically segregating.
In re Wands, 858F.2d 731, 8 USPQ2d 1400 (Fed. Cir. 1988) lists eight considerations for determining whether or not undue experimentation would be necessary to practice an invention. These factors are: the quantity of experimentation necessary, the amount of direction or guidance presented, the presence or absence of working examples of the invention, the nature of the invention, the state of the prior art, the relative skill of those in the art, the predictability or unpredictability of the art, and the breadth of the claims.
It doesn’t appear that Applicant has taught a repeatable method of making and using a Cannabis plant designated ‘CK2015’, and any deposited seed would not appear to be capable of producing/growing a plant of Cannabis plant designated ‘CK2015’. As addressed above, Cannabis plant designated ‘CK2015’ was produced by an outcross breeding method. It does not appear that the deposit enables the claimed invention, and it would have required undue trial and error experimentation to make and use the invention as claimed.
In Wyeth v. Abbott Laboratories, 107 USPQ2d 1273, at 1276-1277 (Fed. Cir. 2013), the court teaches that, the specification…discloses only a starting point for further iterative research in an unpredictable and poorly understood field, the resulting need to engage in a systematic screening process for each of the many rapamycin candidate compounds is excessive experimentation. The court thus held that there is no genuine dispute that practicing the full scope of the claims, measured at the filing date, required undue experimentation.
Applicant argues that the Examiner's presumption that any seed from 'CK2015' would be "widely variable and highly genetically segregating" does not account for the specific breeding history of the deposited line. Applicant argues that the seed line associated with this deposit has been subjected to backcrossing over several generations. Applicant argues that this systematic backcrossing was performed specifically to stabilize and preserve the recited chemotype (the cannabinoid and terpene profiles). Applicant argues that because the deposited seeds represent a stabilized line, a person skilled in the art can reliably reproduce the 'CK2015' plant and its characteristic chemical markers by germinating the deposited material (page 9 of the Remarks).
Applicant’s argument is not found to be persuasive. There is nothing in the instant Specification to suggest Cannabis plant designated ‘CK2015’ was the result of inbreeding and thus reproducible by seed, and Attorney’s arguments cannot take place of evidence and a declaration from the inventor. In fact, the Specification is specific about asexual reproduction of “the new variety” by cutting propagation (paragraph [0013]). The rejection is maintained for the reasons of record.
Claims 1-6 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.
Applicant claims a seed from Cannabis plant designated ‘CK2015’ said plant being obtained by crossing seed parent ‘White Walker OG’ with pollen parent ‘Blue Flame OG Pheno #22’ (page 2, paragraph 0011 of the Specification), and a first- or second-generation descendant thereof and extracts thereof. Applicant does not describe whether either parent is an inbred or double haploid line, thus the Examiner presumes the parental lines themselves are outcrossed and not inbred.
Applicant describes that Cannabis plant designated ‘CK2015’ was obtained by crossing seed parent ‘White Walker OG’ with pollen parent ‘Blue Flame OG Pheno #22’ (page 2, paragraph 0011 of the Specification). Applicant describes that a Cannabis plant designated ‘CK2015’ is asexually propagated by cuttings on page 2, paragraph 0013 of the Specification. Applicant further describes that the cannabinoid and terpene profiles of a Cannabis plant designated ‘CK2015’ is highly variable between plants as exemplified in Table 1 on page 7 and Table 2 on page 8. Hence, any seed taken from a Cannabis plant designated ‘CK2015’ would be widely variable and highly genetically segregating.
Applicant only describes a Cannabis plant designated ‘CK2015’ by how it was produced and by a limited number of morphological characteristics in Table 1 and Table 2. Further, any deposited seed does not appear to describe the Cannabis plant designated ‘CK2015’.
Applicant also does not describe the claimed “first- or second-generation descendant”, “plant descended from” or an extract of a Cannabis plant designated ‘CK2015’ other than by a possible method of making. The requirement for a specific identification is consistent with the description requirement of the first paragraph of 35 U.S.C. 112, and to provide an antecedent basis for the biological material which either has been or will be deposited before the patent is granted. The description must be sufficient to permit verification that the deposited biological material is in fact that disclosed. Once the patent issues, the description must be sufficient to aid in the resolution of questions of infringement. Such a deposit is not a substitute for a written description of the claimed invention. The written description of the deposited material needs to be as complete as possible because the examination for patentability proceeds solely on the basis of the written description. See, e.g., In re Lundak, 773 F.2d 1216, 227 USPQ 90 (Fed. Cir. 1985). See also 54 Fed. Reg. at 34,880.
Hence, it is unclear that Applicant was in possession of the invention as broadly claims. See University of Rochester v. G.D. Searle & Co., 68 USPQ2d 1424, 1433 (DC WNY 2003) which teaches knowing the "starting point" is not enough; that is little more than a research plan. The court held that the disclosure of screening assays and general classes of compounds was not adequate to describe compounds having the desired activity: without disclosure of which peptides, polynucleotides, or small organic molecules have the desired characteristic, the claims failed to meet the description requirement of § 112.
Applicant argues that the seed line was developed through a systematic backcrossing program spanning several generations. Applicant argues that this backcrossing process was specifically employed to preserve the recited chemotype, ensuring that the identifying cannabinoid and terpene profiles are a fixed characteristic of the line.
Applicant argues that a biological deposit, when paired with a specification that describes the resulting stable chemotype and the lineage of the plant, satisfies the written description requirement by providing a "complete" identification of the material. Applicant argues that because the deposited seeds produce plants with the stable, recited characteristics of 'CK2015', the deposit serves as evidence that the inventor had possession of the specific, claimed biological entity and its stable progeny at the time of filing.
Applicant argues that Applicant has amended claim 2 so that the "descendant" reaches to up to two generations removed from a plant grown from the deposited seed. Applicant argues that Applicant has also amended claim 6 to claim a clonal descendant of the seed of claim 1, thus avoiding the allegedly vast and variable genus recited in the Office Action (pages 9-10 of the Remarks).
Applicant’s arguments are not found to be persuasive. There is nothing in the instant Specification to suggest Cannabis plant designated ‘CK2015’ was the result of inbreeding and thus reproducible by seed, and Attorney’s arguments cannot take place of evidence and a declaration from the inventor. In fact, the Specification is specific about asexual reproduction of “the new variety” by cutting propagation (paragraph [0013]). The rejection is maintained for the reasons of record.
Conclusion
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.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID H KRUSE whose telephone number is (571) 272-0799. The examiner can normally be reached Monday-Friday 7AM-3:30PM.
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.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amjad Abraham can be reached on (571) 270-7058. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/David H Kruse/
Primary Examiner, Art Unit 1663
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