DETAILED ACTION
Claims 101-113 are pending.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The objection to claims 102 and 110 because of informalities is withdrawn in light of Applicant’s amendment to the claims.
Claims 102-104 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Massa et al (2019, US 10,506,809).
The rejection of claims 101-112 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35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement is withdrawn in light of Applicant’s deposit statement.
Because viability testing of all deposits is required before they can be considered to meet the requirements of 37 CFR 1.801-1.809, Applicants is required, if the deposit was under the Budapest Treaty, to make a statement that the deposit was accepted under the Budapest Treaty, or, if the deposit was under US practice, to provide evidence of viability. Although Applicant statement that the viability form was attached as Exhibit A, no such exhibit was submitted. Such evidence/statement must be made before the payment of the issue fee. Failure to perfect a deposit by the date of payment of the issue fee may result in abandonment of the application for failure to prosecute.
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 the second paragraph of 35 U.S.C. 112:
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 106 and 110 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 that the inventor or a joint inventor, or for pre-AIA the applicant, regards as the invention. Dependent claims are included in all rejections.
The rejection is modified from the rejection set forth in the Office action mailed 25 June 2025. Applicant’s arguments filed 21 November 2025 have been fully considered but they are not persuasive.
Claim 106 lacks antecedent basis for the limitation “the plant or plant part of claim 105” as claim 105 is drawn to a method.
Claim 110 lacks antecedent basis for the limitation “the seed of Canola hybrid variety 8CN0010” in line 2. Although parent claim 109 recites “a treated seed of Canola hybrid variety 8CN0010”, claim 110’s method of making such a seed would not start with the produce of the method. It is suggested that “the” in line 2 be replaced with --a--.
Response to Arguments
Applicant urges that the claims are amended to overcome the rejections (response pg 8).
This is not found persuasive for the reasons above.
The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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 101-113 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The rejection is modified from the rejection set forth in the Office action mailed 25 June 2025. Applicant’s arguments filed 21 November 2025 have been fully considered but they are not persuasive.
A. Claim 105 requires a plant derived from a plant of canola hybrid variety 8CN0010, and dependent claim 106 requires a haploid derived from a plant that is presumably canola hybrid variety 8CN0010.
The instant specification defines plants derived from a plant of canola hybrid variety 8CN0010 as progeny any generation removed (pg 21, line 19, to pg 22, line 6).
The specification describes no plants derived from a plant of canola hybrid variety 8CN0010.
The specification describes no structural features that plants derived from a plant of canola hybrid variety 8CN0010 from other canola plants.
Canola hybrid variety 8CN0010 is an F1 produced by crossing two unnamed parent canola plants. A haploid derived from it would encompass one that has a mixture of chromosomes, some from one parent and some from the other. A haploid derived from it would encompass one that is produced from a progeny any generation distant from 8CN0010, each generation undergoing crossing over and chromosome assortment.
The specification describes no haploids derived from a plant of canola hybrid variety 8CN0010.
The specification describes no structural features that distinguish haploids from a progeny any generation distant from 8CN0010 from other canola haploids.
Thus, the plant derived from a plant of canola hybrid variety 8CN0010 used in the method of claim 105 and the haploid used in the method of claim 106 only have an unspecified portion of the genes in 8CN0010.
The only species described in the specification is canola hybrid variety 8CN0010.
One of skill in the art would not recognize that Applicant was in possession of the necessary common attributes or features of the genus in view of the disclosed species.
Hence, Applicant has not, in fact, described plants derived from a plant of canola hybrid variety 8CN0010 used in the method of claim 105 or haploids derived from 8CN0010 or a derived from it, and the specification fails to provide an adequate written description of the claimed invention.
Because plants derived from a plant of canola hybrid variety 8CN0010 used in the method of claim 105 or haploids derived from 8CN0010 are not described over the full scope of the claims, the methods of using the them are likewise not described, and the specification fails to provide an adequate written description of the claimed invention.
Therefore, given the lack of written description in the specification with regard to the structural and functional characteristics of the compositions used in the claimed methods, Applicant does not appear to have been in possession of the claimed genus at the time this application was filed.
B. The instant specification fails to satisfy the written description requirement of 35 U.S. Code § 112(a) because it does not provide a description sufficient to conduct an to conduct an examination, including search of the prior art. MPEP 2163 (I) states
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 ("As a general rule, the more information that is provided about a particular deposited biological material, the better the examiner will be able to compare the identity and characteristics of the deposited biological material with the prior art.").
The instant specification fails to satisfy the written description because it does not provide enough description to be sufficient to aid in the resolution of questions of infringement. MPEP 2163(I) states
“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." Id. at 34,880.)” (Quoting the Deposit of Biological Materials for Patent Purposes, Final Rule, 54 Fed. Reg. 34,864 (August 22, 1989) at 34,880).
In the instant application, a full examination cannot be conducted. In claims 101-112, Applicant claims a new canola plant variety. A plant variety is defined by both its genetics (breeding history) and its traits. In the instant application, Applicant has only provided a description of the plant traits as seen in the specification (Table 1). The instant application is silent as to the breeding history used to produce the claimed plant variety.
The criticality of a breeding history in assessing the intellectual property rights of a plant is well recognized in the field of plant breeding. With regard to Plant Patents, MPEP 1605 states that a complete detailed description of a plant includes “the origin or parentage”. Other bodies that grant intellectual property protection for plant varieties require breeding information to evaluate whether protection should be granted to new varieties. A breeding history, including information about parentage and breeding methodology, is part of the requirements of Plant Variety Protection (PVP) applications. That information is used to “determine if development is sufficient to consider the variety new” (USDA, “Applying for a Plant Variety Certificate of Protection”, https://www.ams.usda.gov/services/pvpo/application-help/apply, accessed 1 May 2023). Additionally, the International Union for the Protection of New Varieties of Plants (UPOV) considers breeding history and methodology part of its evaluation of essentially derived plant varieties (UPOV, 2017, Explanatory Notes on Essentially Derived Varieties Under the 1991 Act of the UPOV Convention, see notes 14 and 30). While the USPTO, USDA, and UPOV have different laws governing intellectual property rights, all recognize that a breeding history is an essential part of adequate description of the plant sought to be protected.
The breeding history is also necessary to aid in the resolution of patent infringement by providing information necessary to determine whether differences in plants where genetic differences, differences caused by the environment, or differences within the accepted variation within a variety. Historically, the USPTO has considered breeding history information when determining the patentability of a new plant variety (See Ex Parte C (USPQ 2d 1492 (1992) and Ex Parte McGowen, Board Decision in Application 14/996,093, 2020). In both of these cases, there were many differences cited by the applicant when comparing the prior art and the new plant variety. However, because the breeding history was available, these differences were deemed to be obvious and within the natural variation expected in a backcrossing breeding process. Without a breeding history in these cases, a complete comparison with the prior art could not have been possible.
Moreover, a specification devoid of a breeding history hampers the public’s ability to resolve infringement analysis with plants already in the prior art as well as plants that have not yet been patented. Because the instant specification lacks the breeding history, the public will not be able to fully resolve questions of infringement. Since the breeding history, including the parents, is not known to the public, the public could only rely on the phenotype of the claimed plant for assessing potential infringement.
As seen above in Ex Parte C and Ex Parte McGowan, a trait table is insufficient to differentiate varieties by itself. It has been long established that intracultivar heterogeneity exists in crop species. The assumption that elite cultivars are composed of relatively homogenous genetic pools is false (Haun et al, 2011, Plant Physiol. 155:645-655; see pg 645, left column). Segregation, recombination, DNA transposition, epigenetic processes, and spontaneous mutations are some of the reasons elite cultivar populations will maintain some degree of plant-to-plant variation (pg 645, right column, paragraph 2, to pg 646, left column, paragraph 3). In addition, environmental variation may lead to phenotypic variation within a cultivar. (Großkinsky et al, 2015, J. Exp. Bot. 66:5429-5440; see pg 5430 left column, paragraph 2, and right column, paragraph 2). In view of this variability, a breeding history is an essential and the least burdensome way to provide genetic information needed at adequate describe a newly developed plant.
Thus, an application that does not clearly describe the breeding history does not provide an adequate written description of the invention.
To overcome this rejection, Applicant must amend the specification to provide the breeding history used to develop the instant variety or cultivar. When identifying the breeding history, Applicant should identify any and all other potential names for all parental lines utilized in the development of the instant variety. For example, if Applicant’s breeding history uses proprietary line names, Applicant should notate in the specification all other names of the proprietary lines, especially publicly disclosed or patented line information. If the breeding history encompasses a locus conversion or a backcrossing process, Applicant should clearly indicate the recurrent parent and the donor plant and specifically name the trait or transgenic event that is being donated to the recurrent parent. If any of the parents is a backcross progeny or locus converted line of a publicly disclosed line, Applicant should provide the breeding history of the parent line(s) as well (i.e., grandparents).
Applicant is also reminded of the duty to disclose information material to patentability. Applicant should also notate the most similar plants, which should include any other plants created using similar breeding history (such as siblings of the instant variety). This information can be submitted in an IDS with a notation of the relevancy to the instant application or as information submitted as described in MPEP 724 (e.g., trade secret, proprietary, and Protective Order).
Response to Arguments
Applicant urges that the specification teaches that doubled haploids can be used for the development of inbreds and teaches how to do so (response pg 6).
This is not found persuasive. This not an enablement rejection; it is a written description rejection. The specification does not describe the structural features of plants derived from 8CN0010 for use in the method of claim 105. The specification does not describe the structural features of doubled haploids produced from haploids of 8CN0010 for use in the method of claim 106.
Applicant urges that the written description requirement is provided by the deposit, such that they do not have to provide a breeding history, citing Ex Parte C, Enzo, Ex Parte Berg, Ex Parte Winner, and JEM (response pg 7-8).
This not found persuasive.
While Applicant urges that the deposit provides the description necessary to meet the requirements of written description, that is not the case. The deposit is necessary but not sufficient.
If a deposit were all that were needed, then a phenotype table would not be necessary. However, a plant described only by a deposit cannot be examined; the patent office does not have the facilities to grow up the claimed plant and all canola plants in the art to compare their phenotypes and do a genetic analysis on the claimed plant and plants with the same phenotype or a phenotype that makes obvious the claimed plant to see if the claimed plant is genetically related to the prior art plant.
If a deposit were all that were required to describe a canola plant, then every future canola breeder would need to obtain seed of each and every patented canola plant and each otherwise ever made available to the public and perform a phenotypic comparison and genetic analysis to determine if there is art on any canola plant they invent.
Further, as deposits do not need to be maintained into perpetuity, the genetic information provided therein would no longer be available if there is a 5-year gap after the last request, shutting later breeders out of the information therein. Words describing the phenotype and parents of a canola plant do not shut future inventors out of a description of a prior art canola plant.
Phenotypic and parental (genetic) information as part of the specification and a deposit are all necessary parts of the description of a plant line.
Regarding Applicants’ arguments on the legal basis of the written description rejection and the court’s/board’s interpretations, the best starting point for a written description analysis is the law itself. The first 10 words of 35 USC 112 (a) are critical.
(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. (emphasis added)
The strict interpretation of the law is clear: Applicant must provide in the specification a written description of the invention. The only question is what an “adequate written description” is. This is a fact-based inquiry done by the factfinder (i.e., the examiner) when analyzing the nature of the instant invention.
The references cited in the rejection are evidence regarding that question of fact regarding what is considered when describing plants. They are not cited for legal analysis. The references cited, including USDA and UPOV, establish that in the plant variety art, a breeding history is part of the description of a plant line.
Applicant has not provided evidence saying that in the plant line art the breeding history is not considered part of the description of a plant line. Applicant has not rebutted the evidence provided in the rejection.
The Office has made a finding of fact that for the instant variety the minimum description is the combination of the phenotype and genotype (breeding history). To support this finding of fact, the Office has cited other plant-related intellectual property organizations and relevant court cases dealing with plant varieties in which both the phenotype and genotype are analyzed. The Office did not cite these findings to clarify the law. They are solely to clarify the finding of fact, i.e., what is an adequate written description for the instant plant variety. Applicant’s arguments ask the Office to not consider the actual statute and base our decision solely on statements from court/board cases that do not directly decide what an adequate written description is for a plant variety.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), fourth paragraph:
Subject to the [fifth paragraph of 35 U.S.C. 112 (pre-AIA )], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 105-106 are rejected under 35 U.S.C. 112(d) or 35 U.S.C. 112(pre-AIA ), fourth paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 105 requires a plant derived from the plant of claim 101. However, the method of claim 105 does not actually use the plant of claim 101. Claim 105 thus fails to include all the limitations of the claim upon which it depends.
Claim 106 is drawn to a method of using the plant or plant part of claim 105. Claim 105 is drawn to a method, not a plant or plant part. Claim 106 thus fails to include all the limitations of the claim upon which it depends.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
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.
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 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.
Claim 105-106 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mansiere et al (US 2018/0352776).
The rejection is modified from the rejection set forth in the Office action mailed 25 June 2025. Applicant’s arguments filed 21 November 2025 have been fully considered but they are not persuasive.
The method of instant claim 105 is performed on a plant derived from a plant of canola hybrid variety 8CN0010. The instant specification defines plants derived from a plant of canola hybrid variety 8CN0010 as progeny any generation removed (pg 21, line 19, to pg 22, line 6).
Mansiere et al teach a method of producing an inbred plant from a plant derived from their plant (¶58, claim 53).
The method of instant claim 106 is one of doubling haploids produced from the plant of the instant claim 105. As claim 105 is drawn to a method, not a plant, it is not clear what plant the method is performed on.
However, Mansiere et al also teach a method of producing doubled haploids from the plant (¶59,189-190, claim 54). Mansiere et al’s plant is indistinguishable from a plant derived from a plant of canola hybrid variety 8CN0010, and thus the method appears to anticipate instant claim 106.
Response to Arguments
Applicant urges that Mansiere does not anticipate instant claims (response pg 9).
This is not found persuasive for the reasons above.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anne R. Kubelik, Ph.D., whose telephone number is (571) 272-0801. The examiner can normally be reached Monday through Friday, 9:00 am - 5:00 pm Eastern.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amjad Abraham, can be reached at (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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/Anne Kubelik/Primary Examiner, Art Unit 1663