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 .
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Applicant’s response filed 08/19/2025 in reply to the office action of 05/19/2025 has been entered. Claim 18 has been cancelled. Claims 1-17 and 19-20 are pending.
Claims 1-17 and 19-20 are examined.
Withdrawn objections and rejections
The objection to the specification, the 112(a) rejection regarding the deposit , and 112(b) rejection to the claims have been withdrawn in view of Applicant’s deposit statement. Applicant is reminded to perfect the deposit on or before the issue fee payment.
Written Description Rejection-Missing of breeding history
Claims 1-20 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 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. This rejection is repeated for the reasons of record as set forth in the last office action. Applicant’s arguments filed 08/19/2025 have been fully considered but are not deemed persuasive.
As stated in the last office action, in the instant application, a full examination cannot be conducted because applicant failed to provide the parental lines and breeding history for the instantly claimed plant variety. Applicant claims a new soybean variety 04183231. 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 or incomplete as to the breeding history used to produce the claimed plant variety.
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).
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 Applicant’s Arguments
Applicant argues that all claims meet the written description requirement. Applicant relies upon the following points to support this position: 1) Applicant argues that in each of Ex Parte C (Exhibit A of the response) and Inari Agriculture (Exhibit B of the response), the deposit of the seed was found sufficient to describe the cultivar and that the public can access the deposit and perform a molecular marker analysis to determine the genetics that would distinguish the claimed cultivar from the other cultivars. This is not found persuasive because here Applicant is expecting from the public to determine what distinguishes the claimed cultivar from the publicly available deposited seed, while the law is clear that it is the specification itself that has to provide the complete written description including the breeding history of the claimed variety. The quotation of the first paragraph of 35 U.S.C. 112(a) CLEARLY states:
(a) IN GENERAL.—The specification shall contain a written description of the invention, ………
Further , the MPEP 2163 states that while the deposit of seed provides supplemental written description to the claimed variety, it is NOT a substitute to the written description. It is also noted that Applicant is claiming F1 hybrid produced by crossing a plant of the soybean cultivar 04183231 (unknown parental lines ) with any second soybean plant of a different genotype, so it is unclear how is that the public can determine the genotype (traits) of the F1 hybrid when no seed is deposited for the F1 hybrid. Applicant is entitled for the F1 hybrid only when the breeding history of the claimed cultivar is disclosed and both parents are pure inbred lines. There is no information in the specification regarding the identity of the parental lines that produces the claimed soybean cultivar 04183231. Further, the specification does not provide any markers or marker information specific for the claimed cultivar, so it is unclear how it is possible that the public can use the deposited seed to genotype their cultivar.
Ex Parte C is cited in the office action not to clarify the law but to show that a trait table alone is insufficient to differentiate varieties by itself. The references, the MPEP portions and related case laws are cited in the office action to show what is considered an adequate written description. They are not cited for legal analysis. The cited references establish that the breeding history and parental lines are a part of the written description of a plant variety in the art of plant variety. Applicant is, therefore, required to disclose the breeding history and parental lines to provide a sufficient written description for the claimed soybean variety. The law under 35 USC 112 (a) is clear that it is Applicant’s own specification that has to provide sufficient written description and the distinguishing characteristics of their claimed cultivar. Applicant has provided no evidence to the contrary.
For all the reasons discussed above and in the last office action, the rejection is proper and maintained.
Remarks
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.
No claim is allowed.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MEDINA AHMED IBRAHIM whose telephone number is (571)272-0797. The examiner can normally be reached Monday-Friday, 9:00 - 6:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, SHUBO ZHOU can be reached at 5712720724. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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MEDINA AHMED. IBRAHIM
Primary Examiner
Art Unit 1662
/MEDINA A IBRAHIM/ Primary Examiner, Art Unit 1662