Status of the Application
This Office action is in response to the Amendment and Remarks filed 26 November 2025
The objection to the Drawings is withdrawn in view of Applicant’s amendment to the Specification to include the sequence ID numbers and submission of corrected Figure 1.
The rejection under 35 U.S.C. 112 (a) for lack of adequate written description is withdrawn in view of Applicant’s amendments to the claims.
Specification
The Specification as amended on 26 November 2025 remains objected to because of the included sequence listing on pages 21 and 22 which does not comply with 1.821(c) which states that “a “Sequence Listing,” which is a separate part of the specification”.
Applicant argues that while sequences are provided in the specification, a sequence listing was filed when the application was filed. Applicant argues that the sequence listing filed fulfills the requirement of 37 C.F.R. § 1.821(c). Applicant argues that as there are no rules about providing sequences in the specification, and a sequence listing was filed in the application to meet the requirement of 37 C.F.R. § 1.821(c) (page 7 of the Remarks).
Applicant’s argument is not found persuasive, 37 C.F.R. § 1.821(c) is clear about sequence listings in an Application. Pages 21 and 22 should be deleted from the Specification proper because there is already a separate sequence listing.
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 and 4-20 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 method of producing a Cannabis haploid plant in a single generation using a pollen parent comprising a mutation in the DMP8 locus and the product of said method.
Applicant teaches crossing “a male inducer C” Cannabis plant with a female Cannabis plant on page 17 of the instant Specification and asserts identification of a haploid progeny (PH4) on page 18 of the Specification. Applicant teaches the “male inducer C” line has a deletion at the 5th codon encoding a glutamine (Glu) in Figure 1. Both instant SEQ ID NO: 4 and SEQ ID NO: 5 comprise the same deletion at the 5th codon encoding a glutamine. Applicant teaches that CRISPER mediated mutations that are inherited through seeds are still not possible with Cannabis on page 4, 1st paragraph of the Specification. Applicant teaches that the “male inducer C” line and(?) “male inducer K” line are naturally occurring misfunction mutation(s) in the sperm expressed DMP8 allele of Cannabis on page 4, 2nd paragraph of the Specification.
Applicant does not teach any additional mutations in a Cannabis DMP8 gene that produces a haploid plant when the mutant plant is used as the male parent. Applicant does not teach that the “male inducer C” line or the “male inducer K” line is widely available to the public without restriction. Applicant does not teach a Cannabis haploid seed that is genetically identical with the pollenated Cannabis plant (instant claim 20).
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.
Instant claim 1 as presently amended appears to require a specific Cannabis mutant line and it is unclear that the recited male inducer lines are widely publicly available. The invention appears to employ novel plants. Since the plant is essential to the claimed invention it must be obtainable by a repeatable method set forth in the specification or otherwise be readily available to the public. If the plant is not so obtainable or available, the requirements of 35 USC § 112 may be satisfied by a deposit of the plant. The specification does not disclose a repeatable process to obtain the plant and it is not apparent if the plant is readily available to the public
Further, selective mutation of the DMP8 gene in Cannabis does not appear to be routine, and chemical mutagenesis would have required undue trial and error experimentation by one of skill in the art as of the effective filing date of the instant claims.
Hence, it would have required undue trial and error experimentation to make and use the invention as broadly claimed.
Applicant argues that a person skilled in the art would be able to identify pollen comprising a mutation in DMP8, wherein the mutation is encoded by the nucleic acid sequence of SEQ ID NO:4 or SEQ ID NO:5, then use that pollen to pollinate a Cannabis plant, collect a seed from the pollinated Cannabis plant, identify a putative haploid Cannabis plant from the seed, and then produce a Cannabis haploid plant in a single generation. The specification, at least at pages 16-19, describes the method and the production of the Cannabis haploid plant in a single generation, and further, the specification provides the specific mutation in the DMP8 sequence that is used when obtaining the pollen for pollination. As such, a person skilled in the art in view of the specification and knowledge in thIn 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.
e art would be able to perform the claimed method without undue experimentation (pages 8-9 of the Remarks).
Applicant’s argument is not found persuasive because to practice the claimed invention one of skill in the art would need to be in possession of a cannabis plant that produces pollen comprising the recited mutation in the DMP8 gene. Applicant’s identification of a naturally occurring mutation does not necessarily mean one of skill in the art can reproduce the mutation without undue trial and error experimentation. It is Applicant’s responsibility to enable the claimed invention. 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.
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.
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/David H Kruse/
Primary Examiner, Art Unit 1663