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 .
Claims
Claims 1-22 are pending.
Claims 20 and 22 are newly amended.
Claims 1-22 are rejected.
Claim Interpretation
The words “variety” and “line” are used interchangeably throughout the specification, and therefore they are interpreted to have the exact same meaning in the context of the instant bean line/variety SVGV2138.
Response to Applicant Arguments - 35 USC § 112 (Enablement)
In response to Applicant’s arguments and amendments to the claims dated 03/13/2026, the enablement rejections of record are withdrawn.
Specifically, in response to applicant’s assertion that a deposit was made and accepted at the NCMA under the terms and requirements of the Budapest Treaty, 37 C.F.R. 1.801-1.809, and MPEP 2402-2411.05 and all restrictions upon availability of the deposit to the public will be irrevocably removed upon granting of the patent above their signature and further statement that the specification and claims will be amended upon indication of allowable subject matter, to recite the deposit accession number when completed, the enablement rejections of record are withdrawn.
Response to Applicant Arguments - 35 USC § 112 (Written Description)
The written description rejections of record were made on three different grounds as follows:
Claim 11 is rejected given the unlimited number of transgenes which could be comprised in the plant of claim 11 and the lack of description of this broad genus.
Claims 1-22 are rejected due to the lack of a detailed breeding history.
Claims 20-22 are rejected due to the limitation of detecting at least first polymorphism in a sample, given that the genetic characteristics of the variety are unclear given the lack of breeding history.
With respect to the rejection of record against claim 11, in the response filed 03/13/2026, applicant has not amended the claim and there do not appear to be any arguments directed towards this claim. As such the rejection of record is maintained.
With respect to the rejections of record against claims 1-22 and the additional line of rejection against claims 20-22 applicant’s arguments and amendments dated 03/13/2026 have been fully considered but are not found to be persuasive. Applicant’s arguments are summarized and responded to below.
Applicant’s arguments are summarized as follows and will be addressed below:
Citing selected case law, Applicant argues that “The Office’s assertion that § 112(a) requires disclosure of a complete breeding history is legally and factually incorrect. It also rests on standards from Plant Patent practice and PVP/UPOV regimes that are inapplicable to utility patent examination under § 112” (Remarks, Paragraph spanning pages 6-7).
The Examiner disagrees.
The best starting point for a written description analysis is not interpretation of the patent law by courts, but the law itself. With respect to written description, the first 10 words of 35 USC § 112(a) are very important:
“The specification shall contain a written description of the invention…” (emphasis supplied).
Accordingly, the strict interpretation of the law is clear. Applicant must provide in the specification a written description. The only question is what is an “adequate written description”. This is a fact-based inquiry done by the factfinder (the USPTO examiner) when analyzing the nature of the instant invention.
In this case, 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 the 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 (that is - what is an adequate written description for the instant plant variety). Applicant’s arguments essentially ask the Office to not consider the actual statute and to base the decision solely on statements from court/board cases that do not directly decide what an adequate written description is a for a plant variety.
Therefore, for at least the reasons of record, and those reasons indicated above, the rejection is maintained.
Claim Rejections - 35 USC § 112(a) (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.
Claim 11 remains 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 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, at the time the application was filed, had possession of the claimed invention.
The claim is drawn to a bean produced by a method of adding a desired trait to bean variety SVGV2138 comprising introducing a transgene into said variety. It is notable that any number of traits could be impacted depending on the location of the insertion such that it would be difficult to determine whether or not any given bean plant is a product of said method, particularly given that no limitations are placed on the morphological and physiological characteristics. Without such limitation, any number of traits could be altered rendering the bean plant unrecognizable from bean variety SVGV2138, instantly disclosed.
In contrast, the specification only describes bean variety SVGV2138 and single locus conversions, or transgene conversions therefrom wherein the morphological and physiological traits therefrom are otherwise retained.
Accordingly, the claim lacks adequate written description because one of skill in the art would not be able to determine if they were in possession of the claimed subject matter due to the breadth of the claim.
Lack of Breeding History
Claims 1-22 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 there is no breeding history included in the disclosure.
Specifically, in the instant application, applicant has only provided a description of the plant traits as seen in the specification. The instant Specification is incomplete as to the breeding history used to produce the claimed plant variety.
The breeding history is incomplete because the pedigrees of the plant line is not known in the art and not provided in the Specification. It is not clear what is the source of this plant line or the lines used to produce it. The breeding history must be clarified regarding synonyms, tradenames and the sources thereof.
In the instant application, Applicant claims a new plant variety and methods of producing the variety. This introduces a question of fact: what is an adequate written description of a plant variety.
In searching for an answer to the above question of fact, a search of the relevant art provided answers on what constitutes written description of a plant variety. A plant variety is defined by both its genetics (which are described in the breeding history) and its traits. The following are presented as a review of the state of the art with respect to the question of fact presented above; what is written description of a plant. The following is not presented as a legal basis for the rejection.
In plant breeding a breeding history in considered critical in describing a variety and assessing the intellectual property rights of a plant. 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/drawings 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).
Of interest the MPEP notes that in addition to demonstrating that the applicant is in possession of the claimed invention that the disclosure should have several other characteristics as follows:
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).
Claims 20-22 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 instant Specification fails to satisfy the written description requirement of 35 U.S. Code § 112(a) because there is no breeding history included in the disclosure. This issue of breeding history affects claims 20-22 which are drawn to methods of determining the genotype of the plant of claim 1 or a progeny plant thereof by detecting at least a first polymorphism in a sample (Emphasis added).
As stated above, the breeding history is an effective and efficient method of describing the genetic characteristics of a variety. In order to determine the genotype of the claimed plant and the progeny thereof the ordinary artisan would need to know the specific genetic characteristics of the claimed variety.
Given that the claims are drawn to determining the genotype not only of plants of the claimed bean line but also of any progeny plants the scope of this claim is more broad than it appears at first. For example, genotyping a F8 progeny produced from the claimed bean line using solely outcrossing steps falls within the scope of the claim even though at this point the F8 progeny is entirely genetically distinct from the claimed cultivar.
Given that the specification does not provide the breeding history, it does not appear that the ordinary artisan is in possession of the claimed methods of determining the genotype of the plant of claim 1 because it is not clear that the applicant is in possession of the genetic information of the claimed invention absent a detailed breeding history. Further, even if the applicant is in possession of this genetic information, given that the scope of the claims includes any progeny plant whatsoever, even those that are entirely genetically distinct from the claimed bean line it does not appear that applicant is in possession of the full scope of these broadly claimed methods.
Closest Prior Art
Applicant has not provided a breeding history which as noted in the written description rejection above is required for a complete search of the instant invention. Therefore, this is a provisional statement of prior art as only the phenotypic characteristics of the claimed plant can be searched without the genetic information provided in a breeding history.
The instantly claimed plant appears to be free of the prior art. The closest prior art is found in Bean Line SVGA4608 taught in US Patent Number: US 10,334,813 B1 by Arie Oppelaar on July 2, 2019. The prior art bean shares most of the same traits as the instant bean (compare Table 1 in columns 5-7 of the reference with Table 1 on pages 9-12 of the instant specification). The beans appear to differ in their genetics although the breeding history of the instant bean is unknown. The instant and reference beans also differ in bract size, dry color, pod width, pod thickness, shape in cross section, crease back, number of seeds per pod, curvature of beak, coat luster, veining, shape in cross section and seed length. Thus the varieties appear to be distinct.
Conclusion
All claims are 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.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN JAMES SULLIVAN whose telephone number is (571)272-0561. The examiner can normally be reached 7:30 to 5:00.
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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/BRIAN JAMES SULLIVAN/Examiner, Art Unit 1663
/Amjad Abraham/SPE, Art Unit 1663