Detailed Action
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 23-24, 26, 32-33 and 35 are cancelled.
Claims 1-22, 25, 27-31, 34 and 36-39 are examined.
Withdrawn objections
The objection to claim 37 is withdrawn in light of amendments made by Applicant.
Withdrawn rejections
The rejection of claims 12 and 13 under 35 USC 112(b) is withdrawn in light of amendments made by Applicant.
The rejection of claims 1-39 under 35 USC 112(a) for failing to comply with the enablement requirement is withdrawn in light of amendments made by Applicant.
Written Description
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.
A. Claims 19-20 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 written description requirement. 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 inventor(s), 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 the rejection set forth in the Office action mailed 6/3/2025, as applied to claims 16, 19-20, 23-24, 26, 32-33 and 35.
Claims 19-20 encompass plants of higher filial generations. These plants encompass less than half of the genome of the deposited variety.
Applicant describes lettuce variety CS16201 (Table 1) represented by seed deposited with the NCMA under Accession No. 202303013 (paragraph 207).
Applicant has not described a representative number of species across the broad genera claimed. Applicant has not described F2 or higher filial generation plants produced by crossing lettuce variety CS16201 with a different lettuce plant and self-pollinating the resulting F1 hybrid plant for one or more generations. The only structure described by Applicant is lettuce variety CS16201 (Table 1) represented by seed deposited with the NCMA under Accession No. 202303013 (paragraph 207).
Therefore, Applicant has not described a representative number of species nor a structure-function relationship for the broadly claimed genera.
Applicant’s arguments regarding rejection under 35 USC 112(a) for failing to comply with the written description requirement (part A.)
Applicant's arguments filed 9/3/2025 have been fully considered but they are not persuasive.
Regarding Applicant’s argument that claim 19 has been amended to be dependent on claim 17 rendering the claim moot, the open-ended language of the method of claim 17, i.e., “comprising”, means that the claim is not limited to the cross explicitly recited in the claim but additional crosses which would make the product produced therefrom encompass higher filial generations which would not be represented by the deposit.
B. Claims 1-22, 25, 27-31, 34 and 36-39 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. Applicant claims a new plant variety and methods of producing the 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 incomplete 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, 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 lacking 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).
Applicant’s arguments regarding rejection under 35 USC 112(a) for missing breeding history
Applicant's arguments filed 9/3/2025 have been fully considered but they are not persuasive.
Applicant argues that the amendment to the specification is sufficient and that otherwise a request for information to obtain proprietary breeding history information should be filed.
This argument has been fully considered but it is not persuasive.
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 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.
Applicant has not rebutted the evidence provided in the rejection. Applicant has not provided evidence demonstrating that the breeding history is not considered art of the description of a plant variety.
Regarding Applicant’s argument that a Rule 105 request is the proper way for information to be provided to facilitate examination, this argument has been fully considered but it is not persuasive. The breeding history must be included in an amendment to the specification so that it can accessible. Therefore, the submission in a separate filing does not overcome the rejection.
Closest Prior Art
The claims are free of the prior art. The closest prior art is Avila (US10798901), which teaches lettuce cultivar CVX576-1. Instantly claimed CS16201 and CVX576-1 share many traits but differ in at least head shape and heat dormancy.
Conclusions
Claims 1-22, 25, 27-31, 34 and 36-39 remain rejected.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID R BYRNES whose telephone number is (571)270-3935. The examiner can normally be reached 9:00 - 5:00 M-F.
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, Joe Zhou can be reached at (571) 272-0724. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DAVID R BYRNES/Examiner, Art Unit 1662
/MYKOLA V. KOVALENKO/Primary Examiner, Art Unit 1662