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 December 17, 2025. Claims 1-3, 5 and 7-27 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All previous rejections not set forth below have been withdrawn.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 1-3, 5 and 7-27 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 the breeding history for the instantly claimed plant line. Specifically, in claim 1, Applicant claims a new tomato plant line. A plant line 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 silent or incomplete as to the breeding history used to produce the claimed plant line.
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 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 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, line 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 and all other potential names 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 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. If the claims encompass a progeny of the instant plant, all patent applications and patents that claim a progeny or progenies of the instant plant must also 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 the breeding history for line FDS-YA19-6068 in a separate Information Disclosure Statement (IDS) communication. However, this disclosure is insufficient because it does not address all the issues set forth above, and a specification devoid of a breeding history hampers the public’s ability to fully resolve questions of infringement. 35 USC 112(a) clearly states “The specification shall contain a written description of the invention” (emphasis added). A IDS communication is not part of the Specification and cannot provide the written description required to be in the Specification.
Correction is required.
Applicant’s Traversals
Applicant traverses primarily the following: (1) Deposit-based written description for biological material is expressly recognized and satisfied in the present case. (2) 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. One skilled in the art therefore cannot, as one can do with a fully described genus, visualize or recognize the identity of the members of the genus” (emphasis added). Here, all members of the claimed genus of tomato plants and seeds share the structural feature of having the genetic complement of tomato line FDS-YA19-6068, and one of skill in the art viewing the specification could readily identify the members of the genus. (3) A complete breeding history is not required. (4) The specification aids in resolving infringement. (5) The asserted finding lacks substantial evidence under the governing legal standard. (6) Plant patent practice (MPEP 1605), PVP requirements and UPOV requirements are legally irrelevant. (7) Adequate written description is defined by the statute and legal precedent. (8) 37 CFR 1.105 and MPEP 724—not 112(a)—provide mechanisms to seek additional information to aid search.
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 [0027] states “A small percentage of variants can occur within commercially acceptable limits for almost any characteristic during the course of repeated multiplication.” The bottom of Table 1 states “These are typical values. Values may vary due to environment. Values that are substantially equivalent are within the scope of the invention.” Further, paragraph [0035] states that an occasional variant trait might arise during backcrossing, introduction of a transgene, or application of a genetic engineering technique. Thus, the claims are not directed to the deposited seeds or plants grown therefrom. The recitation of tomato line FDS-YA19-6068 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, no information is provided in the Specification as to how the claimed line was obtained, or whether the parents of said line are publicly available. In a separate IDS communication filed January 16, 2025, Applicant discloses that the claimed line was developed from crossing substantially homozygous, proprietary lines FDS-177-APER and FDSXJ12-6013 followed by pedigree selection until the F10 generation. Thus, absent the disclosure in the communication, one skilled in the art would not have known how the claimed line was produced. However, such a communication is not part of the Specification and cannot provide the written description required by the statute to be in the Specification. Thus, the breeding history for the claimed line as disclosed in the Specification is incomplete.
With regard to traversal (1), a deposit alone does not satisfy the written description requirement. If this were true, then Applicant need not provide any description whatsoever for the claimed line in the Specification. MPEP 2163(I) states “a showing of possession alone does not cure the lack of a written description”, citing Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956, 969-70, 63 USPQ2d 1609, 1617 (Fed. Cir. 2002). “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." (Quoting the Deposit of Biological Materials for Patent Purposes, Final Rule, 54 Fed. Reg. 34,864 (August 22, 1989) at 34,880).
With regard to traversal (2), since the genus encompasses members that are genotypically and phenotypically different from the deposit and from the characteristics disclosed in Table 1, progeny plants having half of the chromosomes of said members cannot be adequately described. No morphological and physiological characteristics are disclosed for plants having half of the chromosomes of line FDS-YA19-6068. The Office agrees and complies with the decision in The Regents of The University of California v. Eli Lilly and Co., 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.” In the instant application, the IDS communication discloses that the claimed line is obtained by crossing parent plants FDS-177-APER and FDSXJ12-6013. Absent the communication, one skilled in the art would not have known what parents were used to produce the claimed line. No genotypic, phenotypic or public availability information is given for FDS-177-APER and FDSXJ12-6013. Thus, the parent name designations alone are not given patentable weight, consistent with the holding in The Regents of The University of California v. Eli Lilly and Co. As stated above, Applicant acknowledges that the claimed genus encompasses plants having genotypic and phenotypic variations in a population of one or more individuals. Thus, in addition to the phenotypic characteristics and the deposit of representative seeds, the above requested information is also material to patentability.
With regard to traversal (3), Applicant is claiming a genus of plants that are genotypically and phenotypically different from the deposited material and from the morphological and physiological characteristics disclosed in Table 1. As no other information is disclosed, and many tomato varieties share the same morphological and physiological characteristics, the breeding history is essential to distinguish the claimed genus of plants from other plants.
With regard to traversal (4), contrary to Applicant’s allegations, the Patent Owner is not making the genetic sequence (genotype) of the claimed line available because claims 23-25 would preclude anyone from performing a marker analysis or DNA sequencing to detect a polymorphism without infringing the claimed invention. If a marker analysis cannot be performed, then Applicant’s assertion that written description can be satisfied by way of the deposit is misleading. Applicant’s claims 23-25 in effect would make the public an infringer to genotype the instant variety as a means to distinguish their plant from the instant line. It should be noted that no genetic marker information is disclosed to distinguish the genus of claimed plants from other plant when Applicant is in the best position to do so. Polymorphisms exist within the genus of plants claimed. Applicant’s failure to provide this information is evidence that it is not practical to do a marker analysis to distinguish Applicant’s genus of claimed plants from others.
With regard to traversals (5) and (7), 35 USC 112(a) clearly states “The specification (emphasis added) shall contain a written description of the invention”. The strict interpretation of the law is clear. Applicant must provide in the specification a written description. A separate communication submission cannot satisfy this statutory requirement because said submission is not part of the specification.
With regard to traversal (6), the above cited documents, including Plant Patents, PVP and UPOV, 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 line, 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.
With regard to traversal (8), 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. 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 (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 cultivar. Applicant’s arguments ask the Office to not consider the actual statute and to base its decision solely on statements from court or Board cases that do not directly decide what is an adequate written description for a plant variety. These arguments are not persuasive.
Accordingly, the rejection is maintained.
Conclusion
3. No claim is allowed.
4. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, 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 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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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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/PHUONG T BUI/Primary Examiner, Art Unit 1663