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
Status of objections and rejections
1. Claims 1-20 are pending. Accordingly, claims 1-20 are examined on merits in the present Office action.
2. Objection to the specification is withdrawn in light of amendments to the specification filed in the papers of August 18, 2025.
3. Objection to claims 1, 6, 11, 13, 14, 15 and 18 is withdrawn in light of amendments to the claims filed in the papers of August 18, 2025.
4. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
5. Rejection of claims 1-20 under 35 U.S.C. 112(b), as being indefinite is withdrawn in light of amendments to the claims filed in the papers of August 18, 2025.
6. Rejection of claims 1-20 under 35 U.S.C. 112(a) as failing to comply with the enablement requirement is withdrawn in light of amendments to the claims filed in the papers of August 18, 2025.
Claim Rejections - 35 USC § 112 (Written Description)
7. 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 the reasons of record stated in the Office action mailed in the papers of May 21, 2025.
Applicant traverses the rejection in the papers filed December 18, 2025.
Applicant’s arguments have been fully considered but are not persuasive. The written description rejection is maintained for the reasons set forth below.
I. The Issue Is Not Merely Examination Convenience—The Specification Fails to Demonstrate Possession
Applicant repeatedly asserts that the Office is requesting breeding history merely to “facilitate examination” or for “convenience.” This is incorrect. The rejection is maintained not because the Office requires breeding history as a matter of examination convenience, but because the absence of any breeding history, parentage, or structural description prevents the specification from demonstrating that Applicant was in possession of the claimed soybean variety at the time of filing. Without structural information (e.g., pedigree, parental lines, derivation), the specification does not identify what the claimed variety is, as required by §112(a). The Office is not permitted to assume possession where the specification provides no structural basis for the claimed plant.
The statute is explicit:
35 U.S.C. § 112(a) (first paragraph)
“The specification shall contain a written description of the invention… in such full, clear, concise, and exact terms as to enable any person skilled in the art to… make and use the same.”
A description that allows a skilled artisan to verify what the invention is—and what it is not—is a fundamental requirement. For biological material, including newly developed plant varieties, this necessarily includes structural identification, not merely functional or phenotypic traits.
Depositing seeds does not excuse or replace the requirement that the specification itself must describe the invention in sufficient detail to demonstrate possession. As explained below, a seed deposit is not a substitute for a structural description when the genus is broad, variable, or unpredictable, or when the claimed subject matter cannot be defined solely by phenotype.
As one can clearly see the law requires that under first paragraph of 35 USC 112(a), and the first paragraph of pre-AIA 35 USC 112 require that the “specification shall contain a written description of the invention….” This has not be done in the present case by not providing the breeding history of the claimed soybean variety ES2020144. Biological deposit of seeds would not indicate parents that were used to create the instantly claimed seed.
Applicant’s attention is drawn to MPEP at
2163 Guidelines for the Examination of Patent Applications Under the 35 U.S.C. 112(a) or Pre-AIA 35 U.S.C. 112, first paragraph, "Written Description" Requirement [R-01.2024] under 3rd paragraph of item I (General principles governing compliance with the "written description" requirement for applications), which says:
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.")
This implies 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. Without knowing the parents of the claimed soybean variety, how one skilled in the art can conclude or establish the Applicant was in possession of the claimed invenrion.
II. A Seed Deposit Alone Does Not Provide the Required Structural Description or Demonstrate Possession to satisfy Automatically Written Description
Applicant asserts that a seed deposit under the Budapest Treaty satisfies § 112(a). This is not correct as a general rule. A deposit may satisfy enablement for reproducing the biological material, but written description is a separate requirement and is not automatically met by the act of depositing seeds.
Both Ariad and Eli Lilly make clear that written description requires the inventor to show possession by reference to structure, not merely function or a physical sample. Applicant’s arguments ignore this critical distinction.
Key Federal Circuit Principles (Ariad; Eli Lilly)
(i) Written description requires demonstrating possession of the claimed structure.
(ii) Description by function alone (or by phenotype alone) is not sufficient.
(iii) A genus must be supported by a representative number of species or by identifying common structural features.
In the instant case, the claimed soybean plant variety ES2020144 is defined solely by (1) a name, (2) a deposit number, and (3) a phenotypic trait table. The specification contains: (a) No breeding history; (b) No parental information; (c) No structural description of the genotype; and (d) No description of how the claimed variety arises from its antecedent structure. Because soybean varieties are known to exhibit intracultivar genetic heterogeneity, the absence of a structural description (i.e., breeding history and genetic origin) prevents a skilled person from determining what structural features define the claimed variety. This is precisely the type of defect that the Federal Circuit warned of in Eli Lilly and subsequent cases. A deposit does not provide structural information in the specification, and therefore cannot satisfy written description whereas here the claimed organism is a plant variety that is routinely described by pedigree and genetic origin. Applicant therefore has not demonstrated possession.
Pioneer Hi-Bred v. Holden Confirms Deposit and Phenotype Alone Are Not Enough
The insufficiency of phenotype-only or deposit-only characterization is reinforced by Pioneer Hi-Bred Int’l v. Holden Foundation Seeds, Inc., 35 F.3d 1226 (8th Cir. 1994). Although Pioneer addressed trade secret issues, the court’s observations are directly relevant: (i) Plant varieties cannot be reliably identified or distinguished by phenotype alone; (ii) Genetically different lines may exhibit indistinguishable phenotypes; (iii) Environmental conditions may mask or alter phenotypic traits; and (iv) The true identity of a plant variety lies in its genetic composition, not merely in observable characteristics. The Pioneer court emphasized that the genotype—not phenotype—defines a plant line. This directly supports the Office’s position: a seed deposit and phenotypic table do not establish written description because the specification still lacks structural description demonstrating possession of the claimed variety ES2020144.
III. Applicant Misinterprets In re Lundak, Enzo, and PTAB Precedent
a. In re Lundak
Lundak held only that deposits need not precede filing. It did not hold that a deposit satisfies written description, nor did it eliminate the requirement for structural description.
b. Enzo Biochem
Enzo held that a deposit may support written description in cases where the microorganism cannot otherwise be described. Enzo stands for the proposition that a deposit may support written description when the deposit supplies the only means to describe the invention—e.g., a unique microorganism whose structure is otherwise unknowable. In the instant case, Applicant is claiming a plant variety, not an undefined microorganism. Unlike microorganisms, plant varieties are routinely described by breeding history, which is standard and expected in plant science and is the structural basis of the plant’s genotype. Plants, however, can be described structurally through: (i) breeding pedigree; (ii) genetic origin; (iii) recurrent parentage, and (iv) breeding methodology. Because plant breeders routinely document and disclose breeding history (Plant Patents, PVP, UPOV guidelines, prior PTAB decisions), Applicant cannot rely on Enzo to avoid providing the standard structural description. Applicant cannot rely on Enzo to avoid providing the standard structural information used by plant breeders and plant patent applicants.
C. Inari v. Pioneer (PTAB 2024)
The cited PGR decision involved: (a) a different factual context; (b) a different legal burden (post-grant review); and (c) a situation where the challenger had the burden, not the applicant. It may be noted that PTAB decisions are not binding on the Examination Corps and do not override Federal Circuit law requiring structural description. Moreover, Inari explicitly limited its finding to whether the challenger had met its burden regarding indefiniteness—not whether the specification satisfied § 112(a) when first filed. Thus, Applicant’s reliance on Inari is misplaced.
IV. Breeding History Is Required Because It Is the Structural Description of a Plant Variety
Applicant argues that breeding history is irrelevant or that plant patent/PVP/UPOV practices should not apply.
These sources are not cited to impose external standards, but because they accurately reflect scientific reality:
(i) A plant variety is defined by its genotype (structural origin) and not solely by its phenotype. Phenotype alone is insufficient due to environmental effects, known intracultivar variation, and the existence of closely related sister lines. This is not a “convenience argument.” It is a structural-description argument.
(ii) Intracultivar Genetic Variation Undermines Phenotype-Only Description, Environmental Variability Affects Phenotype & Authority supporting the need for genetic/structural detail.
Studies such as (a) Haun et al. document significant intracultivar genetic heterogeneity in soybean varieties, meaning different genotypes can produce overlapping phenotypes; (b) Großkinsky shows substantial environmental phenotypic variability; and (c) Ex Parte C and Ex Parte McGowen both show that breeding history is essential for distinguishing varieties and determining possession and obviousness.
It is noted that Applicant selectively quotes Ex Parte C, but ignores the portion where the Board emphasized that: “the examiner’s concern is that appellant’s specification does not serve to distinguish the invention from other things before known.” That is precisely the defect in the present specification: Without breeding history, the claimed variety cannot be structurally distinguished from prior art varieties or their sister lines, nor can possession be established.
(iii) Pioneer Hi-Bred v. Holden Confirms That Phenotype Alone Cannot Define a Variety:
The Eighth Circuit’s reasoning in Pioneer Hi-Bred v. Holden directly supports the Office’s position: (a) Phenotypic data alone cannot uniquely identify a plant line; (b) Genetically distinct lines may appear similar; (c)Environmental influences limit phenotypic reliability; and (d) The genotype is the structural identity of the variety. The court explicitly recognized that plant identity rests in its genetic origin, which is precisely what is absent from Applicant’s specification. Thus, Pioneer reinforces the conclusion that breeding history, pedigree, and genetic origin are necessary to define and describe a plant variety, and therefore necessary for written description.
V. Rule 105 Cannot Cure a Written Description Deficiency
Applicant argues that the Office should request pedigree information under 37 CFR 1.105. This misapprehends the legal issue. Rule 105 cannot be used to add missing written description to the specification because: (i) Rule 105 can request information for examination but do not become part of the original disclosure.; (ii) Rule 105 cannot add missing written description to the specification; and (iii) The written description must be present at time of filing.
Therefore, Rule 105 cannot cure a §112(a) deficiency.
VI. Applicant Has Not Demonstrated Possession as Required by Ariad
Under Ariad Pharm. v. Eli Lilly, possession requires: (a) A structural description; (b) A representative number of species, or; (iii) A correlation between structure and function.
In the instant case, Applicant has not provided: (a) structural description; (b) parentage or pedigree: (c) breeding method; (d) genotype–phenotype correlation, or (iv) representative structural species. The deposit alone does not create a “written description” of structure. Written description must be in the specification, not in the depository.
As none of the Ariad criteria for written description are met, the rejection is maintained.
VII. Conclusion and Required Action
For the reasons stated above, Applicant has not overcome the written description rejection.
The specification does not demonstrate possession of the claimed soybean variety ES2020144 because it lacks any structural description of the invention. To overcome the rejection, Applicant must amend the specification to include: (a) Full breeding history; (b) Parentage of all lines involved; (c) Description of breeding methodology (e.g., backcrossing, locus conversion); (d) Identification of recurrent and donor parents; (e) Identification of alternative or public names of parental lines; and (e) Breeding history of parental or grandparental lines if applicable. Such information is required to establish possession and allow a skilled artisan to understand the structural identity of the claimed plant. Until such an amendment is made, the rejection under 35 U.S.C. § 112(a) (written description) is maintained.
In light of these arguments, Office maintains that 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. 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 soybean plant variety ES2020144. Specifically, in claim 1 applicant claims a new soybean plant variety ES2020144. 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 (see pages 45-48. The instant application is silent or incomplete as to the breeding history used to produce the claimed soybean plant variety ES2020144.
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.
Contrary to Applicant’s arguments, it is important to note that an Applicant shows possession of the claimed invention by describing distinguishing identifying characteristics sufficient to show that the Applicant was in possession of the claimed invention (see MPEP 2163 § 2163[R-5]I). This has not been done in the present case. In the instant case, by not disclosing breeding history in the specification, one of skilled will not be able to know genetic profile of parents from the deposited seeds of the claimed variety.
The Federal Circuit has clarified the application of the written description requirement to inventions in the field of biotechnology. See University of California v. Eli Lilly and Co., 119 F.3d 1559, 1568, 43 USPQ2d 1398, 1406 (Fed. Cir. 1997). In summary, the court stated that a written description of an invention requires a precise definition, one that defines the structural features of the chemical genus that distinguishes it from other chemical structures. A definition by function does not suffice to define the genus because it is only an indication of what the gene does, rather than what it is. The court goes on to say, “A description of a genus of cDNAs may be achieved by means of a recitation of a representative number of cDNAs, defined by nucleotide sequence, falling within the scope of the genus or of a recitation of structural features common to members of the genus, which features constitute a substantial portion of the genus.” See University of California v. Eli Lilly and Co., 119 F.3d 1559; 43 USPQ2d 1398, 1406 (Fed. Cir. 1997). In the instant case, by not disclosing breeding history in the specification, one of skilled will not be able to know genetic profile of parents from the deposited seeds of the claimed variety.
Thus, under Lilly and its progeny, the Specification does not show possession of a sufficient number of sequences falling within their potentially large genus to establish possession of their claimed genus. See Cf Enzo, 323 F.3d at 964 ("if the functional characteristic of... binding to [CD48] were coupled with a disclosed correlation between that function and a structure that is sufficiently known or disclosed," the written description requirement may be met). Without a correlation between structure and function, the claim does little more than define the claimed invention by function. That is not sufficient to satisfy the written description requirement. See Eli Lilly, 119 F.3d at 1568, ("definition by function ... does not suffice to define the genus because it is only an indication of what the gene does, rather than what it is"); see also Kubin, 83 USPQ2d at 1416-17. In the instant case, by not disclosing breeding history in the specification, one of skilled will not be able to know genetic profile of parents from the deposited seeds of the claimed variety.
Applicant fails to describe a representative number of species as encompassed by the breadth and scope of the claims. Applicant fails to meet either prong of the two-prong test set forth by Eli Lilly. Applicant fails to establish structure-function relationship for a representative number of species as encompassed by the breadth and scope of the claims because deposited seeds cannot establish structure (genetic profile) that can be correlated to a function or functions as recited for example in the Table 1.
Also see in re Curtis (69 USPQ2d 1274 (Fed. Cir.2004), where the court held that there was sufficient evidence to indicate that one of ordinary skill in the art could not predict the operability of other species other that the single one disclosed in the specification. The court held that a disclosure naming a single species can support a claim to a genus that includes that species if a person of ordinary skill in the art, reading the initial disclosure, would “instantly recall” additional species of the genus already “stored” in the minds, but if other members of the genus would not “naturally occur” to a person of ordinary skill upon reading the disclosure, then unpredictability in performance of species other than specifically enumerated defeats claims to the genus.
Accordingly, it is maintained that there is lack of adequate description to inform a skilled artisan that applicant was in possession of the claimed invention at the time of filing. See Written Description guidelines published in Federal Register/Vol.66, No. 4/Friday, January 5, 2001/Notices; p. 1099-1111.
It is thus maintained that given the claim breadth and lack of guidance as discussed above, the specification does not provide written description of the genus broadly claimed. Accordingly, one skilled in the art would not have recognized Applicants to have been in possession of the claimed invention at the time of filing.
In view of above, the requirement for written description has not been met.
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).
Conclusion
8. Claims 1-20 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.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Vinod Kumar whose telephone number is (571) 272-4445. The examiner can normally be reached on 8.30 a.m. to 5.00 pm. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amjad A. 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. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA).
/VINOD KUMAR/Primary Examiner, Art Unit 1663