DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 30 Apr 2026 has been entered.
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 .
Claim Status
Claims 1-3 & 7-15 are under examination on the merits.
Claims 4-6 are canceled.
Priority
Claims 1-3 & 7-15 receive the U.S. effective filing date of 08/23/2023
Information Disclosure Statement
Applicant has responded that “Examiner…[has noted]…that the IDS submissions have been received and were considered” [Remarks, p.5, ¶3]. There is no IDS form of record currently included with the instant application.
Applicant is reminded the listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Previous rejection of claims 2, 5, 8 & 11 under 35 U.S.C. 112(a) for failing to provide full scope of enablement is withdrawn in view of Applicant’s amendment to the claims.
Previous rejection of claim 1 under 35 U.S.C. 101 is withdrawn in view of Applicant’s amendment to the claims.
Previous rejection of claims 2 & 15 under 35 U.S.C. 102(a)(1) is withdrawn in view of Applicant’s amendment to the claims.
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 1-3 & 7-15 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with written description requirements. The claims contain 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 inventors, 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 that set forth in the Office action mailed 30 Oct 2025, as previously applied to claims 2, 5, 8 & 11. Applicant's arguments filed 30 Apr 2026 have been fully considered but they are not persuasive.
Regarding claims 1-3; these recite methods of creating a stable polyploid plant through self-fertilization. Biologically, this requires doubling the chromosomes either naturally or artificially so as to provide a uniformly polyploid, stable plant.
In the specification, Applicant provides background on the general use of chemical agents to alter chromosome number in crop plants which is well known [¶31]. They further go on to explain that Cannabis is particularly tricky to work with in this field of endeavor, tending towards ‘mixaploid’ tissues wherein multiple levels of chromosome doubling or reduction can occur naturally and coexist within a single plant [¶35]. This suggests that traditional methods or expectations of altering chromosome number do not work when applied to Cannabis and that the inventive method of claims lies in being able to solve this problem.
Applicants claim to have solved this problem by a method of generating plants of a stable, doubled ploidy level by self-pollinating a haploid Cannabis plant. They do not define ‘stable’ or ‘stabilizing’ relative to any specific level of genetic homogeneity or heritability. Applicant does define several genetic states not considered diploid. They refer to the genomic constitution of a ‘mixaploid’ in drawing 3C at [¶60], as “mixaploid (n + 2n) state”, and also on page 7 [¶38] as a mixaploid state being one in which a plant has cells with varying ploidy levels and some cells with different numbers of chromosome sets.
Their written description does not provide any details of the process of manipulation of chromosomes in the Cannabis plants. One sentence is provided at [¶71] stating, “At step 601, a plant is treated with colchicine (or any chemical that will achieve increasing a ploidy level such as a doubling of the chromosomes with Oryzalin).” Referring to Step 601 to see if any further detail is provided the drawing simply states, “TREAT A HAPLOID PLANT WITH COLCHICINE”. They also state elsewhere in the specification that colchicine is rarely, if ever, able to produce fully diploid Cannabis plants [¶31].
The only specific information disclosed by Applicant is that of embodiments in Figures 1 – 5, which consist of pictures of a single, individual leaf from each of several cultivars and corresponding flow cytometry data. The cytometry data shows relative percentage of cells of each level of polyploidy in their cultivar series. Applicant describes the example series for ‘Mary Jane Manhunt’ at [¶66-69], stating the material is in diploid (2n).
However, contrary to this, their data shows only 58.33% of the sample tissue is diploid. Applicant describes material as haploid (n) when data shows only 61.06% of sample tissue is haploid. Applicant further describes another tissue sample as an ‘exemplary diploid (2n) parent’ when data shows only 38.7% of the sample tissue is diploid. All sample data presented directly contradict the statements of the Applicant and show mixaploid plant tissue based on flow cytometry results, indicating the embodiments are not functionally representative of the claimed inventive method. Thus, in addition to not providing a description of methods used to arrive at example material, it also appears that the examples provided are not stable nor uniform as claimed.
Further, there is no indication of what tissues were used for sampling to arrive at their data, or if the individual plants depicted were sampled over multiple time points or generations of propagation. There is no indication that flow cytometry data is related to reproductive or germline cells, or how or if the instant examples of polyploids can confer the same genetic state observed in the analyzed tissue to progeny or clones.
It is notable that in figures 5A-5D, critical cytometry data is missing. No data is presented showing chromosome content of the doubled-haploid stage plant, [¶66] which would be critical to claims, although chromosomal data is provided for all other relevant steps of the method. Applicant states, “The mixaploid data for the colchicine treated haploid was not gathered” although it is not clear how one would know the colchicine treated plant was mixaploid if no data was gathered to determine its genetic constitution.
Of the data that is provided, the flow cytometry data shows non-uniform chromosomal constitution in all embodiments provided. No tissue sample consists of >58% diploid cells, and the ‘stabilized’ examples pointed to by Applicant as their putative diploids all consist of (2n + n) tissues.
Applicant does not describe the process of chromosome manipulation used and their exemplary embodiments appear to contradict the claimed method. Applicants flow cytometry data shows all tissue samples as various mixtures of cell types, and not consistently or uniformly diploid. As such, none of the materials included in the specification demonstrate possession of the claimed invention. The specification as currently written provides a disclosure of interesting genetic material maintained by Applicant that may have arisen spontaneously or naturally at the described states, all of which is still mixaploid.
As written, the specification does not demonstrate possession of the claimed invention. There is not enough information provided by Applicant for one skilled in the art of the plant breeding to reasonably consider Applicant is in possession of the claimed inventive method. Further, the embodiments provided appear to contradict the method claims, additionally indicating Applicant is not in possession of the claimed invention. Because of this, claims 1-3 & 7-15 are rejected.
Response to Arguments
Applicant’s arguments filed 30 Apr 2026 have been fully considered but are not persuasive.
Applicant urges amendment to claims overcomes previous 112 rejection of claims 2, 5, 8 & 11 [Remarks, p.5, ¶5].
This is unpersuasive because Applicant has merely amended claims to specify plants involved are Cannabis plants, and provided a definition of the act of self-pollination (i.e. such that the plant’s pollen fertilizes its own ovules). However, this does not address issue of lack of written description regarding the claimed method and resulting plants. The technical details necessary to practicing the claimed inventive method in Cannabis are not described, and no explanation is provided regarding the apparently mixaploid plants presented in the embodiments.
Applicant is silent as to the lack of method steps describing the chromosome doubling process or necessary technical detail(s) to achieve fully diploid Cannabis plants via chromosome doubling. Applicant is also silent as to the contradictory data provided by their examples with respect to the stability and/or uniformity of tissues in their plant material.
As such, the previous rejection is maintained for lack of possession.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 3, 7, 9-10, and 12-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Crawford [Crawford et al. Genes 2021, 12, 923; Published: 06-17-2021].
Due to Applicant' s amendment of the claims, the rejection is modified from that set forth in the Office action mailed 30 Oct 2025, as previously applied to claims 2, 5, 8 & 11. Applicant's arguments filed 30 Apr 2026 have been fully considered but they are not persuasive.
Claim 1 is drawn to doubling the chromosomes of Cannabis (i.e. converting from a haploid to a diploid, from a diploid to a tetraploid, from a tetraploid to an octoploid, etc.), self-fertilizing that plant, and creating an offspring with the intended doubled chromosome number. Dependent claims 7 & 10 narrow from 1 to limit the method to subcategories of the genus Cannabis.
The generation of tetraploids [i.e. ‘doubling a plant’s ploidy’] in Cannabis, referred to as C. sativa or hemp, is disclosed by Crawford. They describe manipulating the chromosome number of Cannabis sativa with a microtubule inhibitor and production of tetraploid seed [Materials & Methods, p.3, ¶2].
They also describe the value of such techniques of chromosome manipulation used to make ‘seedless’ or other polyploids in Cannabis, p.1 par.2, in that avoiding pollination and seed formation increases essential oil yield by more than 55%. They summarize the motivation of their research as p.2 par.5, “Given the potential advantages of ploidy manipulation in C. sativa, our goal was to produce and test…diploid, triploid, and tetraploid type IV C. sativa plants.”
Crawford anticipates claims 1, 7, & 10 of the instant application. The limitation of doubling a plant’s ploidy in the instant application is taught in Crawford’s Materials & Methods [p.3, ¶2]. The subsequent self-fertilization of the resulting ‘doubled plant’ along with generation of offspring of the desired doubled ploidy targeted is also taught in their Materials & Methods [p.3, ¶2]. The dependent claims 7 & 10 are anticipated in Cannabis by Crawford [p.2, ¶5]. Because all steps of claims 1, 7 & 10 are taught by Crawford, the claimed method is anticipated and claims 1, 7 & 10 are rejected.
Claim 3 claims a two-component method of treating a genetically female plant with a microtubule inhibitor, which is a chemical agent that can alter chromosome number, and also with an ethylene blocker so as to effect a sex-change. The two components together would increase or alter the chromosome number of the plant and confer the ability of that treated female plant to generate pollen and fertilize itself, generating seed or offspring, and potentially becoming a self-perpetuating variety or breeding line.
Claim 12 is dependent from claim 3 and narrows by specifying that the method be applied to the genus Cannabis or categories of Cannabis comprising ‘hemp’. Claim 13 is dependent from claim 3 and narrows by specifying that the female plant to be fertilized is the specific, individual plant that was treated with the ethylene blocker. This differs slightly from claim 3, wherein the fertilized plant could be a genetically identical but physically separate ‘clone’ plant.
The method of claim 3 and its narrowing claims is taught in Cannabis by Crawford. They describe manipulating the chromosome number of Cannabis sativa, specifically referring to hemp [first sentence of Abstract and throughout text], with a microtubule inhibitor combined with use of an ethylene blocker (i.e. silver compounds) to effect sex-change of the treated plants so they can be self-pollinated to produce seed. In their Materials & Methods they describe generation of tetraploids and selfing them [p.3 ¶2] This very specifically teaches the method of claims 3 & 12-13 in the instant application.
On page 3, ¶2, Crawford does not specifically indicate they are treating genetically female plants verbatim; however, they indicate they are treating 40 seedling plants. A population of seedling Cannabis plants are inherently a mix of male and female plants, or are entirely female in the case of feminized seed. It is expected that at least one or more plants from a given seed-grown population of dioecious plants would be genetically female, absent evidence to the contrary. Crawford simply does not state this obvious and inherent quality of their plant material because presumably it is so obvious to those skilled in the art as to not warrant reporting. In a study of female flower production/yield, one would necessarily include female plants.
Similarly, Crawford does not specifically use the slang term or word ‘marijuana’ in their academic research study. However, in section 4.2, ¶2 they teach that their research would be applicable in other usage or market classifications of Cannabis, other than hemp. Crawford thus, without resorting to using the word ‘marijuana’ verbatim, explicitly describes use of their same method in categories of Cannabis sativa other than the classification they define as ‘hemp’. Such alternate classifications would include ‘marijuana’, as claim 9 of the instant application states, or any other name by which Cannabis sativa could be commonly known or called.
Crawford clearly anticipates claims 3, 9 & 12-13 of the instant application. The method of claim 3 involves treating of a female plant with chemicals to inhibit microtubules and block ethylene in order to generate self-pollinated seed or offspring. Crawford teaches all limitations of this in their disclosure, specifically with reference to their ‘P163’ inbred line of Cannabis and its tetraploid derivatives. Moreover, they describe self-pollination of the specific, individual ‘P163’ plants treated with colchicine and silver thiosulfate. They specifically teach that such a method could apply to any category of Cannabis, whether known as ‘marijuana’ or any other common name.
Response to Arguments
Applicant’s arguments filed 30 Apr 2026 have been fully considered but are not persuasive.
Applicant urges that 102 rejection is improper due to claim amendments which specify the process of self-fertilization and that the process of self-fertilization is ‘not found anywhere within Crawford’ [Remarks, p.6, ¶1]. They argue that because Crawford does not clearly describe the process of self-fertilization that the prior art does anticipate every element of the rejected claims.
This is unpersuasive because Crawford clearly teaches the self-fertilization of Cannabis plants as, “Six colchicine-treated seedlings that were estimated to be tetraploids were then treated with silver thiosulfate…to produce selfed seeds” [p.3, ¶2, lines 11-13]. The process of producing selfed seeds involves the self-fertilization of an individual plant by transfer of pollen from that plant to the stigma of the same (i.e. self) plant. The amended claim language merely provides the definition of how one makes selfed seed when a ‘plant’s pollen fertilizes its own ovules’.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 2, 8, 11 & 14-15 are rejected under 35 U.S.C. 103 as being obvious over Crawford in view of Lubberstedt [U.S. Patent Application US 20220002739 A1; Published: 01-06-2022].
Due to Applicant' s amendment of the claims, the rejection is modified from that set forth in the Office action mailed 30 Oct 2025, as previously applied to claims 2, 5, 8 & 11.
The claims are drawn to methods of generating doubled haploid plants via self-fertilization of Cannabis, including spontaneous doubling of plants.
Crawford teaches chromosome manipulation to create polyploid varieties of Cannabis, as described previously [see above, p.10—p.11, ¶1].
Crawford does not teach ‘spontaneously doubled haploids’ or methods of doubling chromosomes in haploid plants without use of chemical agents.
Lubberstedt teaches self-pollination of haploids to generate doubled haploid (n + n = 2n) maize plants. They claim methods of using spontaneously doubled haploids in claim 1, and describe the technical aspects of this [¶7-16; Example 4, ¶265-279]. Further, they point to the limitations of the chemically-induced processes used by Crawford and others and why an alternative which does not rely on chemical microtubule inhibitors would be valuable [¶4].
They teach the specific inventive method in the detailed description comprising ‘spontaneous genome doubling’ (i.e. ‘n + n’ or doubled haploid) which does not require use of a genome doubling agent [¶7-16]. They teach that the doubled haploid plant is allowed to produce progeny germlines which are fully homozygous, doubled haploid inbred lines. They state that such materials are exactly what plant breeders use to pursue hybrid development programs [¶87-88].
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify the polyploid Cannabis breeding method(s) taught by Crawford to those using spontaneously doubled plants as described in Lubberstedt. It would be obvious to apply a known technique (i.e. use of spontaneous doubling) to a known method (i.e. generation of polyploid Cannabis) to yield predictable results (i.e. doubled haploids without chemical hazards).
One of ordinary skill in the art would have been motivated to do so because Crawford directly states the benefits of intentional use of spontaneous haploid genome doubling are numerous [¶6]. They teach that use of spontaneous doubling removes greenhouse costs, saves on labor costs, and eliminates use of a hazardous chemical. These are all improvements over the existing, chemical-dependent system(s).
Regarding claims 2, 8, 11 & 15; the limitations of a Cannabis plant being self-fertilized to stabilize a diploid germline are met by Crawford [p.3 ¶2; p.2, ¶5] with the teaching of Lubberstedt describing such process with haploids to generated doubled haploids.
Regarding claim 14; the limitation of such process occurring in the absence of chemical treatment (i.e. spontaneous doubling) is taught by Lubberstedt [¶7-16; Example 4, ¶265-279].
The commercial and economic value of suggested improvements of not requiring a microtubule inhibitor would a valuable improvement to one interested in producing polyploid plants of any species, including Cannabis. The shortcoming of Crawford’s approach in relying on chemical mutagens, which are toxic and require extra precautions, to double Cannabis chromosomes and the clear arguments for adopting an alternate non-chemical system such as taught by Lubberstedt.
Because of these reasons, it would be obvious to one skilled in the art of plant breeding to combine the disclosure provided by Crawford with the teachings of Lubberstedt to claim a generic method of ‘doubling a plant’s ploidy’ utilizing a plant with ‘spontaneously doubled haploids’, as previously described in maize by Lubberstedt.
Conclusion
No claims are allowed.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KEITH R WILLIAMS whose telephone number is (571)272-3911. The examiner can normally be reached Mon - Fri, 9:30 - 5:30 EST.
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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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/KEITH R. WILLIAMS/Examiner, Art Unit 1663 /Amjad Abraham/SPE, Art Unit 1663
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