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 .
Status of Claims
The amendments and remarks submitted on 18 November 2025 have been entered.
Claims 1-20 are pending and are examined in this Office action.
Status of Objections and Rejections
All previous objections and rejections not set forth below have been withdrawn in view of Applicant’s amendments and/or upon further consideration.
The text of those sections of Title 35 U.S. Code, not included in this action, can be found in a prior Office action.
Claim Rejections - 35 USC § 112
Written Description
Claims 1-20 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; for reasons of record stated on pages 2-7 in the Office Action mailed 08/26/2025. 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.
A. A deposit is not a substitute for description of the claimed invention
The claims all require plants and seeds of soybean seed designated as 01106155, representative sample of seed having been deposited under NCMA Accession No.202306015.
A deposit is not a substitute for description of the claimed invention. See MPEP 2163:
An applicant shows that the inventor was in possession of the claimed invention by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention. Lockwood v. Amer. Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997). Possession may be shown in a variety of ways including description of an actual reduction to practice, or by showing that the invention was "ready for patenting" such as by the disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the inventor was in possession of the claimed invention. See, e.g., Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 68, 119 S.Ct. 304, 312, 48 USPQ2d 1641, 1647 (1998); Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406; Amgen, Inc. v. Chugai Pharm., 927 F.2d 1200, 1206, 18 USPQ2d 1016, 1021 (Fed. Cir. 1991) (one must define a compound by "whatever characteristics sufficiently distinguish it"). "Compliance with the written description requirement is essentially a fact-based inquiry that will ‘necessarily vary depending on the nature of the invention claimed.’" Enzo Biochem, 323 F.3d at 963, 63 USPQ2d at 1612. An application specification may show actual reduction to practice by describing testing of the claimed invention or, in the case of certain biological materials, by specifically describing a deposit made in accordance with 37 CFR 1.801 et seq. See Enzo Biochem, 323 F.3d at 965, 63 USPQ2d at 1614 ("reference in the specification to a deposit may also satisfy the written description requirement with respect to a claimed material"); see also Deposit of Biological Materials for Patent Purposes, Final Rule, 54 Fed. Reg. 34,864 (August 22, 1989) ("The requirement for a specific identification is consistent with the description requirement of the first paragraph of 35 U.S.C. 112, and to provide an antecedent basis for the biological material which either has been or will be deposited before the patent is granted." Id. at 34,876. "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.) Such a deposit is not a substitute for a written description of the claimed invention. 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."). (emphasis added)
Hence, Applicant has not, in fact, described soybean 01106155 by virtue of the deposit alone, and the specification fails to provide an adequate written description of the claimed invention.
B. The breeding history of the soybean variety 01106155 is not described
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 claims are drawn to a soybean variety 01106155 and its parts, methods of making the plant, and methods of using it.
The Specification is silent on the breeding history of the soybean variety 01106155.
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, in claims 1-20, applicant claims a new soybean variety 01106155. 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.
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; accessed May 1, 2023). 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; April 6, 2017). 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 (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. For example, Haun et al. teaches that the assumption that elite cultivars are composed of relatively homogenous genetic pools is false (Haun et al., 2011, The Composition and Origins of Genomic Variation among Individuals of the Soybean Reference Cultivar Williams 82, Plant Physiology 155: 645-655; at 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 variations (Haun et al., page 645 right column, and page 646 left column). In addition to genetic variation, environmental variation may lead to phenotypic variation within a cultivar (Großkinsky et al., 2015, Plant phenomics and the need for physiological phenotyping across scales to narrow the genotype-to-phenotype knowledge gap, Journal of Experimental Botany 66(18): 5429-5440; at 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.
For the sake of completeness, it is noted that applicant briefly mentions that soybean variety 01106155 was developed from an initial cross of MK0920A5-B0DNN/EV2116A2-TILNN (Specification, page 6, paragraph 0016). In the reply filed on 11/18/2025 Applicant has amended the Specification to include the statement that parental line MK0920A5-B0DNN is a nonpublic proprietary line. However, no further information regarding the parental line EV2116A2-TILNN has been provided.
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:
The Applicant’s arguments in the response submitted on 18 November 2025 have been carefully considered but they were not found to be persuasive. Applicant has presented a plurality of arguments supported by various Exhibits (Remarks, pages 3-14). Citing selected case law, Applicant argues and concludes that the Office’s Written Description Rejection must be withdrawn (Id.).
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.
Summary
No claim is allowed.
Claims 1-20 are deemed to be provisionally free of the prior art, given the failure of the prior art to teach or suggesting a soybean plant having all of the morphological and physiological characteristics of the deposited soybean variety (soybean seed designated as 01106155, representative sample of seed having been deposited under NCMA Accession No. 202306015). It should be noted that this statement is based only on a comparison of the morphological and physiological characteristics of the deposit against the prior art. This is statement is provisional because Applicant has not provided any information regarding the parental lineage or breeding methodology used to produce the deposited soybean variety. Without this information, a meaningful comparison of the genetic and phenotypic basis that would distinguish the deposited soybean variety from prior art plants cannot be made. Thus, this statement will remain provisional until the necessary information requested above is received, corrections are made to the description, and a complete search of the prior art is can be completed.
The closest prior art appears to be CARLSON (Carlson, United States Patent No. 11,343,990 B2, granted May 31, 2022), which discloses soybean variety 01083439 that shares many characteristics with the instantly claimed variety, but differs in at least resistance to glufosinate and parental genetics. The instant variety is not disclosed by the prior art and the prior art does not otherwise render the claimed subject matter obvious.
THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 date of this final action.
Examiner’s Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRATISLAV STANKOVIC whose telephone number is (571)270-0305. The examiner can normally be reached Monday-Friday, 08:00-17:00 h EST.
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 Yvonne (Bonnie) Eyler can be reached at (571) 272-1200. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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BRATISLAV STANKOVIC, JD, PhD
SPE, Art Units 1661 & 1662
/BRATISLAV STANKOVIC/Supervisory Patent Examiner, Art Units 1661 & 1662