DETAILED ACTION
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 3 April 2026 has been entered.
Claims 1-24 are pending.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 112
The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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.
Claims 1-24 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 claims contain subject matter that 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The rejection is repeated for the reasons of record as set forth in the Office action mailed 9 October 2025. Applicant’s arguments filed 3 April 2026 have been fully considered but they are not persuasive.
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 to conduct an examination, including search of the prior art
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.").”
The instant specification fails to satisfy the written description because it does not provide enough description to be sufficient to aid in the resolution of questions of infringement.
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. In claims 1-22, Applicant claims new tomato plant lines. 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 seen in the specification (Tables 1-2). The instant application is silent or incomplete as to the breeding history used to produce the claimed plant lines.
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” (USDA, “Applying for a Plant Variety Certificate of Protection”, https://www.ams.usda.gov/services/pvpo/application-help/apply, accessed 1 May 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 (UPOV, 2017, Explanatory Notes on Essentially Derived Varieties Under the 1991 Act of the UPOV Convention, see 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, 2020). 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. The assumption that elite cultivars are composed of relatively homogenous genetic pools is false (Haun et al, 2011, Plant Physiol. 155:645-655; see pg 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 (pg 645, right column, paragraph 2, to pg 646, left column, paragraph 3). In addition, environmental variation may lead to phenotypic variation within a cultivar. (Großkinsky et al, 2015, J. Exp. Bot. 66:5429-5440; see pg 5430 left column, paragraph 2, and right column, paragraph 2). 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/drawing to provide the breeding history used to develop PSQ-XL20-1160 and PSQ-XL18-1090. 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 any 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(s) 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 Arguments
Applicant argues that breeding history is not needed, citing Enzo, letters from USDA’s Moffitt and USPTO’s Brent, Ex Parte C, Ex Parte McGowen, Inari, the statutory text of § 112(a), 37 C.F.R. §§ 1.801-1.809, Requests for Information, PLT, PVP, and UPOV Requirements, MPEP 2163(I), Tables 1 and 2 of specification, the deposits, and an Office action in 17/961,366 (response pg 6-21).
Applicant’s arguments are not found persuasive.
A deposit is necessary but not sufficient to meet the requirements of written description.
If a deposit under 37 C.F.R. §§ 1.801-1.809 were all that were needed, then phenotype Tables 1 and 2 would not be necessary. However, a plant described only by a deposit cannot be examined; the patent office does not have the facilities to grow up the claimed plant and all tomato plants in the art to compare their phenotypes and do a genetic analysis on the claimed plant and plants with the same phenotype or a phenotype that makes obvious the claimed plant to see if the claimed plant is genetically related to the prior art plant.
If a deposit were all that were required to describe a tomato plant, then the public would not be informed. Every future tomato breeder would need to obtain seed of each and every patented tomato plant and perform a phenotypic comparison and genetic analysis to determine if there is patent art on any tomato plant they invent.
Further, as deposits do not need to be maintained into perpetuity, the genetic information provided therein would no longer be available if there were a 5-year gap after the last request, shutting later breeders out of the information therein. Words describing the phenotype and breeding history of a tomato plant do not shut future inventors out of a description of a patented tomato plant.
Phenotypic and parental (genetic) information as part of the specification and a deposit are all necessary parts of the description of a plant line.
In Enzo the deposited bacteria were not claimed. In the instant application, not only are the deposited plants claimed, but the deposited varieties with a transgene or single locus conversion, F1 progeny, where the second plant is anything that will cross with tomato, and the F1 progeny with a transgene or single locus conversion are claimed, as well. Also in Enzo, the Neisseria meningitidis host cells used to make the deposited bacteria were described. Thus, the fact patterns of Enzo and the instant application are markedly different.
Further, Enzo stated that “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). The fact-based inquiry laid out in this rejection establishes that in the plant variety art, a breeding history is part of the description of a plant line.
USDA’s Moffitt asked about breeding histories with respect to written description, but USPTO’s Brent answered by discussing enablement. Brent did not address the written description issue.
With respect to arguments that a breeding history does not enable a person of ordinary skill in the art to make the invention, this is a written description rejection, not an enablement rejection. As discussed in the rejection, and made clear by Moffitt’s letter, a breeding history is critical in assessing the intellectual property rights of a plant and necessary to aid in the resolution of patent infringement.
In Ex Parte C, the specification disclosed the parents, which were publically available, the breeding method, and the generation the claimed plant was selected at, but not the selection criteria, which is what the examiner wanted to know, and the Board said was too much to ask. However, the Board noted “the Patent and Trademark Office rule which relates to the deposit of biological materials specifically requires the specification to include sufficient description of the deposited material not only to specifically identify it but also "to permit examination." (pg 4). A breeding history is critical in assessing the intellectual property rights of a plant and is part of the “additional information to assist in the examination process." A breeding history is also necessary to aid the public in the resolution of patent infringement. The patent at issue in Inari discloses the parents used to make the claimed inbred. Thus, the fact patterns in Ex Parte C and Inari are different from those in the instant application.
While Applicant urges that a Request for Information is sufficient to provide the information needed to examine a claim, a response filed to a Request for Information may be expunged from the application and thus does not inform the public about the critical genetic description of claimed plants.
No decision holding that a breeding history is a mandatory component of written description under § 112(a) for a utility patent claiming a plant variety has been cited because the courts have not addressed the issue as to the instant fact pattern. However, first 10 words of 35 USC 112 (a) are “The specification 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 of the invention. The only question is what an “adequate written description” is. This is a fact-based inquiry done by the factfinder (i.e., the examiner) when analyzing the nature of the instant invention.
The references cited in the rejection are evidence regarding that question of fact regarding what is considered when describing plants. They are not cited for legal analysis. The references cited, including USDA and UPOV, establish that in the plant variety art, a breeding history is part of the description of a plant line.
Applicant has not provided evidence saying that in the plant line art the breeding history is not considered part of the description of a plant line. Applicant has not rebutted the evidence provided in the rejection.
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 this 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, i.e., what is an adequate written description for the instant plant variety. Applicant’s arguments ask the Office to not consider the actual statute and base our decision solely on statements from court/board cases that do not directly decide what an adequate written description is for a plant variety.
Applicant provides no support for their assertion that in the plant breeding industry, plant variety identification and differentiation are performed through phenotypic evaluation and molecular marker analysis. Applicant also does not assert that a breeding history is not used in the plant breeding industry, in contrast to the teaching of the references cited in this rejection.
37 C.F.R. §§ 1.801-1.809 relate to the requirements for making an acceptable deposit, not written description.
With respect to the Office action in application 17/961,366, now U.S. Patent No. 12,324,402, examiners are prohibited from discussing the prosecution of any other application or issued patent.
Applicant is reminded of the following from MPEP 2163 (I) (presented as separate points, although they are a continuous part of a paragraph in MPEP 2163 (I)):
"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." Deposit of Biological Materials for Patent Purposes, Final Rule, 54 Fed.. 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."). [citation added for clarity]
Breeding histories for tomato lines PSQ-XL20-1160 and PSQ-XL18-1090 are necessary for all these purposes.
Claim Rejections - 35 USC § § 102, 103
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Claim 8 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Schroeder (2019, US 10,448,590) taken with the evidence of US 2017/0094921, US 2018/0116153, US 2019/0357462, US 2020/0163303, US 2022/0095572, and US 2023/0105514.
This determination was made using characteristics of tomato variety HP 988 (aka, PSQ 24-988) that do not vary when the plant is grown in different environmental conditions. Appendix A describes the characteristics of HP 988 from US 2017/0094921, US 2018/0116153, US 2019/0357462, US 2020/0163303, US 2022/0095572, and US 2023/0105514. The characteristics in bold are those that are the same in all 6 publications and thus are not affected by the environmental conditions under which the plant is grown. Two plants cannot be compared based on the other characteristics unless they are grown side-by-side.
Schroeder teaches a hybrid tomato variety, NUN 00261 TOP, that appears to have all the non-environmentally affected physiological and morphological characteristics of tomato hybrid SVTM9334. Like SVTM9334 NUN 00261 TOP has anthocyanin in seeding hypocotyls, a normal seeding habit, determinate growth, tomato leaves, an inflorescence type with some branching (mainly uniparous), normal calyx, yellow corollas, sparse style pubescence, fused anthers, absence of fasciation, smooth fruit, a dot pistil scar shape, red fruit with red flesh, yellow fruit epidermis, field culture and adaptation to machine harvest (Table 1). Schroeder is silent on the other non-environmentally affected physiological and morphological characteristics NUN 00261 TOP. Thus, NUN 00261 TOP appears to be a tomato with all the physiological and morphological characteristics of tomato hybrid SVTM9334.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anne R. Kubelik, Ph.D., whose telephone number is (571) 272-0801. The examiner can normally be reached Monday through Friday, 9:00 am - 5:00 pm Eastern.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amjad Abraham, can be reached at (571) 270-7058. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Anne Kubelik/Primary Examiner, Art Unit 1663
