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 .
Claim Status
Claims 89-91, 93-100 are pending and examined on the merits.
Claims 89-90 are currently amended.
Response to Arguments - Specification
Applicant's arguments filed 01 December 2025 have been fully considered but they are partially persuasive. The specification still lacks a breeding history, but has overcome the objection regarding the NCIMB accession number not being recited in specification.
Specification
The disclosure is objected to because of the following informalities:
The specification fails to recite breeding history (see lack of written description rejection below).
Claim Rejections - 35 USC § 112
Scope of Enablement
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.
Claims 89 and 97 remain 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 making and using the claimed hybrid plant, does not reasonably provide enablement for making the hybrid seed without access to the parent varieties of 9CN0103. 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.
The claimed invention is not supported by an enabling disclosure taking into account the Wands factors. In re Wands, 858/F.2d 731, 8 USPQ2d 1400 (Fed. Cir. 1988). In re Wands lists a number of factors for determining whether or not undue experimentation would be required by one skilled in the art to make and/or use the 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 claim.
The claims are broadly drawn to seeds of Canola hybrid 9CN0103. Note that seeds are a part of the plant of Canola hybrid 9CN0103.
Applicants teach how to use the seeds of Canola hybrid 9CN0103.
Applicants do not teach how to make seeds of Canola hybrid 9CN0103.
The state-of-the-art is such that one of skill in the art cannot predict how person of ordinary skill in the art would have been able to make the claimed seeds with knowledge of the identity of and access to the inbred parents of Canola hybrid 9CN0103.
Given the lack of guidance in the instant specification, undue trial and error experimentation would have been required for one of ordinary skill in the art to make the claimed seeds within the scope of the claims.
Therefore, given the breadth of the claims; the lack of guidance and working examples; the unpredictability in the art; and the state-of-the-art as discussed above, undue experimentation would have been required to practice the claimed invention, and therefore the invention is not enabled throughout the broad scope of the claims.
Response to Arguments - Scope of Enablement - Seeds
Applicant's arguments filed 01 December 2025 have been fully considered but they are not persuasive.
Applicant urges that the canola seeds of the claimed variety have been deposited in accordance with the deposit requirements.
This argument is not persuasive, because these scope of enablement rejections are unrelated to deposit practices. 1) The first rejection is based on the fact that hybrid seeds cannot be made without access to the inbred parent lines. Applicant is reminded that to satisfy the enablement requirement, a person of ordinary skill needs to be able to both make and use the invention as claimed.
Lack of Written Description
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.
Claims 89-91 and 93-100 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 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 examination, including search of the prior art, nor does it provide enough description to be sufficient to aid in the resolution of questions of infringement.
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.").”
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 because applicant failed to provide the breeding history for the instantly claimed plant variety. Specifically, applicant claims a new hybrid canola 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. 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” (See “Applying for a Plant Variety Certificate of Protection” by the USDA reference to Exhibit A). 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 (See UPOV EDV Explanatory 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). 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 phenotypes of the claimed plants 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. HAUN teaches that the assumption that elite cultivars are composed of relatively homogenous genetic pools is false. (See Haun Page 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. (See Haun Page 645 right column and Page 646 left column). In addition to genetic variation, environmental variation may lead to phenotypic variation within a cultivar. (See Großkinsky page 5430 left column 1st full paragraph and right column 2nd full paragraph). 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/drawing 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 one 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 as well (i.e. grandparents).
Applicant is also reminded that they have a 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 – Lack of Written Description
Applicant's arguments filed 01 December 2025 have been fully considered but they are not persuasive.
Applicant urges that the deposit alone is sufficient to satisfy the written description rejection. To support this argument, Applicant has cited Enzo Biochem, Inc. v. Gen-Probe, Inc.; Ex parte C; Ex parte Winner; Ex parte Berg; and J.E.M. v. Pioneer.
First, it should be noted that no amendments to the specification have been filed to overcome the rejection of record.
Applicant is reminded that their claims are not solely limited to the deposited seed, but instead encompass plants and seed of 9CN0103 wherein a representative sample of seed of that variety has been deposited under NCIMB Accession No: 44080. The deposited seed represents a genus of what is being claimed. If Applicant fails to provide additional description as to what features are required from a plant or plant part to be considered part of variety 9CN0103, then a person of ordinary skill in the art would not have been reasonably apprised for the scope of the claimed invention. In the case of new plant varieties, most often the breeding history of the instantly claimed variety helps to satisfy the written description requirement.
Ex parte Winner and Ex parte Berg are both factually distinct from the instant case, because those cases both describe plant varieties that have a single identifying phenotype that set the deposited variety apart from other varieties of the same species (a specific floral color pattern in the case of Winner and a specific leaf blade to stick length ratio in the case of Berg). The instant specification fails to describe any single specific identifying feature of the deposited variety that would discriminate the variety from other canola varieties. Thus, Ex parte Winner and Ex parte Berg are non-analogous to the instant fact pattern.
The fact pattern of Enzo is also more closely aligned with Ex parte Winner and Ex parte Berg than the instant case. The claimed subject matter of Enzo is a nucleotide sequence present in a deposited E. coli strain that preferentially hybridizes to deposited Neisseria gonorrhea strains compared to deposited Neisseria meningitidis strains at a ratio of at least 5:1. There is a clear identifying characteristic of the composition of matter comprising the nucleotide sequence that is present in the deposited E. coli strain. The instant case has not described any characteristic of canola hybrid 9CN0103 that clearly discriminates the variety from other canola varieties. This compounded with the fact that the claims are not simply drawn to the deposited variety (note that Enzo is limited to a nucleotide sequence present in a deposited E. coli strain; another reason Enzo is non-analogous to the instant case), but a variety that is represented by the deposit leads to the finding of a lack of written description.
In regard to Ex parte C, Applicant cites the following passage, “a disclosure which describes an invention and enables the practice of that invention in accord with 35 U.S.C. 112, in this case by depositing in a public depository the seed necessary for the practice of the invention.” The deposit does not enable the practice of the claimed invention as a person of ordinary skill in the art cannot make a hybrid seed with access the inbred parents of the hybrid (see lack of enablement rejection above). Thus, the fact pattern of Ex parte C cannot be considered analogous to the instant case.
The citation from J.E.M. v. Pioneer does not say that the deposit is sufficient to satisfy the written description requirement; it states that, “The description requirement includes a deposit of biological material…”
Conclusion
No claims are allowed. 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 extension fee 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 MATTHEW R KEOGH whose telephone number is (571)272-2960. The examiner can normally be reached M-Th 7-4:30, half day on Fridays.
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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/MATTHEW R KEOGH/Primary Examiner, Art Unit 1663