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 .
This is a Final Office Action in response to amendment filed on October 3rd, 2025.
Claims 35-52 are amended. claims 35-52 remain pending and are examined herein.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) or 120, as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The instant application claims benefit from U.S. Application No. 16/930,936, filed July 16, 2020, which application claims priority to U.S. Provisional Application No. 62/875,311, filed July 17, 2019, U.S. Provisional Application No. 62/906,210, filed September 26, 2019, and U.S. Provisional Application No. 62/982,522, filed February 27, 2020.
The amended claims are drawn to transgenic T1 cannabis plants.
The disclosure of the prior-filed application, U.S. Provisional Application No. 62/875,311, 62/906,210, and 62/982,522, fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application.
The 62/875,311 application discloses transformed cannabis explants. However, ‘311 does not disclose, or enable, transgenic T1 cannabis plants.
The 62/906,210 application discloses transformed cannabis explants. However, ‘311 does not disclose, or enable, transgenic T1 cannabis plants.
The 62/982,522 application discloses transformed cannabis explants. However, ‘311 does not disclose, or enable, transgenic T1 cannabis plants.
U.S. Application No. 16/930,936, filed July 16, 2020 is the earliest enabling disclosure.
Therefore, the application is granted with the priority date of July 16, 2020.
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.
Applicant’s amendment to the claims filed on October 3rd, 2025 has necessitated this new ground of rejection. Specifically, the amended claims are drawn to a genetically engineered T1 Cannabis plant comprising a genetic modification in the THCA synthase and CBDA synthase resulting in modified expression or enzyme activity of THCA synthase and CBDA synthase. This amendment reciting “T1 plants” requires a new analysis to appropriately address the scope of the claims especially in view of Applicant’s argument. Accordingly, this new ground of rejection is being presented below.
Claims 35-52 are newly rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for [ genetically engineered T1 Cannabis plant comprising a genetic modification in the THCA synthase and CBDA synthase resulting in modified expression or enzyme activity of THCA synthase and CBDA synthase in the “Honey Gold 3WS” cutivar ], does not reasonably provide enablement for [ . The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make the invention commensurate in scope with these claims.
An “analysis of whether a particular claim is supported by the disclosure in an application requires a determination of whether that disclosure, when filed, contained sufficient information regarding the subject matter of the claims as to enable one skilled in the pertinent art to make and use the claimed invention.” MPEP 2164.01. “A conclusion of lack of enablement means that. . . the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention [i.e. commensurate scope] without undue experimentation.” In re Wright, 999 F.2d 1557,1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993); MPEP 2164.01.
In In re Wands, 858 F.2d 731,8 USPQ2d 1400 (Fed. Cir. 1988), several factors implicated in determination of whether a disclosure satisfies the enablement requirement and whether any necessary experimentation is “undue” are identified. These factors include, but are not limited to:
(A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure. In re Wands, 858 F.2d 731,737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988). No single factor is independently determinative of enablement; rather “[i]t is improper to conclude that a disclosure is not enabling based on an analysis of only one of the above factors while ignoring one or more of the others.” MPEP 2164.01. Likewise, all factors may not be relevant to the enablement analysis of any individual claim.
The amended claims are broadly drawn to a genetically engineered T1 Cannabis plant comprising a genetic modification in the THCA synthase and CBDA synthase resulting in modified expression or enzyme activity of THCA synthase and CBDA synthase.
The claims are broad in scope in that the claims encompass any plants of any species, varieties, cultivars, strains, or lines, in the genus Cannabis. Untill very recently, genome sequencing and bioinformatics have provided greater resolution of taxonomic assignments at the species level. As a result, some historical confusion surrounding the taxonomy of the genus Cannabis taxonomy was clarified based on genomics-based taxonomical approaches and the genus Cannabis is considered of a highly diverse monotypic species (Lapierre, Éliana, Adrian S. Monthony, and Davoud Torkamaneh. "Genomics-based taxonomy to clarify cannabis classification." Genome 66.08 (2023): 202-211.)
In contrast to the broad scope, Applicant has provided enabling guidance for producing T1 transgenic plant (plant “WP421-1”) from the meristem explants of the variety “Honey Gold 3WS”, transformed with Agrobacterium strain Ar18r12v carrying the binary plasmid DICOTBINARY-19.
It is worth noting that the binary plasmid DICOTBINARY-19 does not carry any genetic elements modifying the expression and/or activity of THCA synthase and/or CBDA synthase.
Applicant has not provided enabling teachings, with reasonably predictable success, the stable transformation and regeneration of T1 transgenic Cannabis plants of any species, varieties, cultivars, strains, or lines, in the genus Cannabis.
As Applicant has remarked (Remarks, Oct. 3, 2025), due to the recalcitrant nature cannabis plants are difficult for transformation and regeneration. The state of the art also provde testimony regarding the unpredictable nature of generating stable Cannabis transformants from explants and the lack of adequate enabling guidance. For example: Deguchi (Scientific Reports | (2020) 10:3504 ) teaches that, at the time of the instant application, hemp transformation protocol has not yet been developed due to the low shoot regeneration rate. Holmes (Botany 101.11 (2023): 498-512) further teaches the influence of cannabis genotypes on TF (transformation frequency), whereas while two genotypes (CPH and PNK) produced transgenic calli at different frequencies, a third genotype, PWE, however, developed no putatively transformed calli and produced no calli from leaf sections on the same callus induction media used for CPH and PNK. Holmes teaches that cannabis genotypes likely influence transformation frequencies through their effects on callus development. Holmes teaches that the variable responses of genotypes to callus formation in cannabis have been previously described, that marked differences in callus growth from leaf sections in different Cannabis genotypes.
Similarly, Zhang et al. (Plant Biotechnol. J. 10: 1979–1987) noted differences in regeneration efficiency through shoot and root induction in different hemp genotypes. Zhang teaches that the shoot regeneration efficiency also varied greatly among different cannabis varieties. The genotype effect of one hundred cannabis varieties on regeneration has been estimated and significant differences has been observed between the varieties. Zhang emphasizes that successful regeneration of plants from transgenic cannabis callus still requires optimizing tissue culture protocols for callus induction and inducing shooting for the specific genotypes being used, and that this continues to remain a long-standing challenge.
Therefore, both the instant application and the state of the art has demonstrated the diver and unpredictable nature of producing stable cannabis transformant through regeneration from transformed explants, across the genetically and physiologically diverse range of the genus Cannabis.
Thus, in view of the unpredictability associated with the genotype-dependence of stable transformation and regeneration in the broad and diverse genus of Cannabis, the lack of enabling guidance from either the instant disclosure or the art regarding the predictive features, and breath and diversity of the embodiments encompassed by the claimed genus, the lack of sufficient working examples, and the level of the art at the time of the invention, one of ordinary skill in the art must rely on undue trial and error experimentation to test the numerous Cannabis strains, varieties, cultivars and species encompassed by the broad genus, with different explants and vastly variable combinations of tissue culture media, conditions, Agrobacterium strains, and so on, in order to make and/or use the invention within the full scope of these Claims.
For at least this reason, the Specification does not teach a person with skill in the art how to make and/or use the subject matter within the full scope of these Claims.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 WEIHUA FAN whose telephone number is (571)270-0398. The examiner can normally be reached Monday-Friday, 9-5.
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WEIHUA . FAN
Primary Examiner
Art Unit 1663
/WEIHUA FAN/Primary Examiner, Art Unit 1663