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 .
DETAILED ACTION
1. The Office acknowledges the receipt of Applicant’s amendment filed November 18, 2025. Claims 1-20 are pending and are examined in the instant application.
All previous rejections not set forth below have been withdrawn.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
This action is made FINAL.
Claim Rejections - 35 USC § 112(a)
2. 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 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) further 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 a complete breeding history for the instantly claimed plant variety. Specifically, in claim 1, Applicant claims a new soybean 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 shown 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”, USDA, https://www.ams.usda.gov/services/pv po/application-help/apply, downloaded 05/01/2023, (previously cited)). 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, Explanatory Notes on Essentially Derived Varieties Under the 1991 Act of the UPOV Convention, April 6, 2017, See UPOV EDV Explanatory Notes 14 and 30 (previously cited)). 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 the plants are 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) (previously cited) and Ex Parte McGowen Board Decision in Application 14/996,093, decided June 15, 2020 (previously cited)). 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 complete 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 complete 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 et al. (Plant Physiology, Feb. 2011, Vol. 155, pp. 645-655 (previously cited)) teaches that the assumption that elite cultivars are composed of relatively homogenous genetic pools is false. (p. 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 (p. 645, right column and p. 646, left column). In addition to genetic variation, environmental variation may lead to phenotypic variation within a cultivar. (Großkinsky et al., J. Exp. Bot., Vol. 66, No. 11, pp. 5429-5440, 2015 (previously cited), p. 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 to adequately 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. 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, as well as all potential names for the claimed variety. For example, if Applicant’s breeding history uses proprietary variety names, Applicant should notate in the specification all other names of the proprietary varieties, especially publicly disclosed or patented variety 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 should identify the breeding method used, such as single seed descent, bulk method, backcross method, etc., and the filial generation in which the instant plant was chosen. Information pertaining to the homozygosity or heterozygosity of the parents as well as the instant plant should be set forth.
Applicant is 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). If there any patent applications or patents in which sibs or parents of the instant plant are claimed, the serial numbers and names of the sibs or parents should be disclosed. This information can be submitted in an Information Disclosure Statement 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).
In the instant application, Applicant included some breeding history for variety 01106242 in the Specification and an additional name for one parent in a separate Transmittal Letter communication. However, this disclosure is insufficient because it does not address all the issues set forth above, and the information provided in the Transmittal Letter with regard to the additional name of one parent should be set forth in the specification. A specification devoid of a complete breeding history hampers the public’s ability to fully resolve questions of infringement.
Correction and/or clarification is required.
Applicant’s Traversals
Applicant traverses primarily the following: (1) the Office's contentions and mandate to amend the specification are a significant departure from the Office's examination policy under which many patents have issued and are not in accordance with well-established patent law. (2) The Office cites secondary sources of little to no persuasive value and extracts statements from case law that are either out of context or not controlling law, and the Office has not cited any law (statute, case law, or rule) that requires Applicant to amend its specification to include all public and commercial designations of parental lines in order to satisfy the written description requirement. (3) The Office's contentions disregard the fact that existing rules and procedures permit the Office to conduct a full and thorough examination of the application. (4) The Office's contentions disregard the fact that Applicant has provided to the Office a substantial amount of information regarding the breeding history and lineage of the claimed variety that is more than sufficient for the Office to conduct a thorough examination and ensure that the public's interest in the disclosure of the invention are satisfied. (5) The Office’s written description rejection is not in accordance with Office policy. (6) The Office’s written description is not in accordance with patent law. (7) In re Lundak dicta and Federal Register Comments are not law. (8) The Office’s written description rejection is not supported by requirements for plant patents and PVP applications. (9) The Office’s written description rejection is not supported by Ex Parte C or Ex Parte McGowen. (10) It is not the role of the Office to resolve questions of infringement. (11) Applicant’s disclosures of breeding history information are more than sufficient.
Response to Applicant’s Traversals
Applicant’s traversals have been carefully considered but are deemed unpersuasive for the following reasons. 35 USC 112(a) clearly states “The specification (emphasis added) shall contain a written description of the invention”. This is a question of fact, not a question of law, as to whether the Specification provides adequate written description for the claimed invention (MPEP 2163(I)). The facts are as follows. Applicant has deposited seeds representative of the claimed line. Paragraph [0017] states “Variety 01106242 shows no variants other than what would normally be expected due to environment or that would occur for almost any characteristic during the course of repeated sexual reproduction.” Paragraph [018] states “The results of an objective evaluation of the variety are presented below, in Table 1. Those of skill in the art will recognize that these are typical values that may vary due to environment and that other values that are substantially equivalent are within the scope of the invention.” Further, paragraph [068] states that an occasional variant trait might arise during backcrossing, introduction of a transgene. Thus, the claims are not directed to the deposited seeds or plants grown therefrom. The recitation of soybean variety 01106242 encompasses a genus of plants that are genotypically and phenotypically different from the deposited material and from the characteristics disclosed in Table 1. Turning to its breeding history, Applicant discloses that the parents of variety 01106242 are BN2520C7-B0DNN and AW1912B2-TILNN [016]. However, no genotypic or phenotypic traits are disclosed for the parents, or their public availability. In a separate Transmittal Letter filed April 3, 2025, Applicant discloses that the parent AW1912B2-TILNN is also known as soybean variety 01072331 (US Pat. No. 11096363). Absent the disclosure in the Transmittal Letter, one skilled in the art would not have known that one of the parents has another name, is a prior art variety and is publicly available. However, the Transmittal Letter is not part of the Specification and cannot provide the written description required by statute to be in the Specification. Thus, the breeding history for the claimed line as disclosed in the Specification is incomplete.
With regard to traversals (1), (5) and (6), the Office policy is to follow the law. The well-established patent law for requiring the above information is 35 USC 112(a), which states “The specification (emphasis added) shall contain a written description of the invention”. In evaluating written description, the threshold question is: what is an adequate written description? This is question of fact that is evaluated by the factfinder (examiner). MPEP 2163.04 clearly states that “The inquiry into whether the description requirement is met must be determined on a case-by-case basis and is a question of fact. In re Wertheim, 541 F.2d 257, 262, 191 USPQ 90, 96 (CCPA 1976).” The instant invention is a new soybean variety (01106242). So, the examiner will evaluate what is an adequate written description for a new soybean variety. In reviewing this question of fact, the examiner analyzes how plant varieties are evaluated in the public domain. The review concluded that generally the minimum requirements for an adequate description of a new plant variety are a trait table and genetic information (via a breeding history). In reviewing Applicant’s specification, there is a phenotypic description of the variety in Table 1. Applicant discloses names of two parent varieties but gives no genotypic or phenotypic information for them. Additionally, Applicant omitted to disclose that one of the parents is known by another name and is a prior art variety. The Office concludes that the breeding history is part of the minimum description of a plant variety, that the omitted information is material to patentability, and that Applicant has not fulfilled the requirements of 35 USC 112(a).
With regard to traversals (2), (7), (8) and (9), the above cited documents were not relied upon to determine the requirements for a plant utility application or for legal precedence. They were considered to determine the state of the art as to what is adequate description for a plant variety, and to make a finding of fact as to what constitutes adequate written description in a utility patent. The Office has made a finding of fact that for the instant line, the minimum description is the combination of the phenotype and genotype (breeding history) for the claimed line. To support the finding of fact, the Office has cited other plant-related intellectual property organizations (USDA, UPOV) and relevant court cases (Ex parte C, Ex Parte McGowen) dealing with plant varieties in which both the phenotype and genotype were analyzed. Haun et al. and Großkinsky et al. were cited to show that a trait table is insufficient to differentiate varieties by itself, because intracultivar heterogeneity exists in crop species and environmental variation may lead to phenotypic variation within a cultivar. The Office did not cite these findings to clarify the law. They are solely to clarify the findings of fact, i.e., what is an adequate written description for the claimed variety. The above factual evidence provides a reasonable basis that a breeding history is necessary written description. With this information the examiner has met the initial burden of presenting by a preponderance of evidence why a person of ordinary skill in the art would not recognize in Applicant’s disclosure a description of the invention defined by the claims. (See MPEP 2163.04).
With regard to traversal (3), an adequate written description is not to help the examiner carry out a thorough examination but to preclude the issuance of a patent that would otherwise issue due to Applicant’s omission of critical information from the Specification.
With regard to traversal (4), it is unclear why Applicant does not disclose that parent AW1912B2-TILNN is also known as soybean variety 01072331, is a prior art variety, and is publicly available. No genotypic or phenotypic information is provided for BN2520C7-B0DNN and AW1912B2-TILNN. The Regents of The University of California v. Eli Lilly and Co., 119 F.3d 1559, 1568; 43 USPQ2d 1398, 1406 (Fed. Cir. 1997) noted that a name alone does not satisfy the written description requirement where “it does not define any structural features commonly possessed by members of the genus that distinguish them from others.” Given the facts that Applicant’s disclosure with regard to the breeding history is incomplete, that the recitation of “variety 01106242” encompasses a genus of plants that are genotypic and phenotypic different from each other, and that the claimed variety is genotypically different from the deposit and phenotypically different from the traits set forth in Table 1, the Office concludes that Applicant’s disclosure does not comply with the statute requirements and does not ensure that the public’s interest in the disclosure of the invention is satisfied.
With regard to traversal (10), it is the role of the Office to ensure compliance with the patent statutes and to preclude the issuance of a patent that would otherwise issue due to Applicant’s omission of critical information from the Specification.
With regard to traversal (11), this is a conclusory statement that is contrary to the Office findings as detailed above.
Accordingly, the rejection is maintained.
Conclusion
3. No claim is allowed.
4. 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.
5. Any inquiry concerning this communication or earlier communications from the examiner should be directed to PHUONG T BUI whose telephone number is (571)272-0793. The examiner can normally be reached M-F 8am-5pm.
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/PHUONG T BUI/Primary Examiner, Art Unit 1663