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 April 10, 2026. Claims 1-19 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All previous rejections not set forth below have been withdrawn.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.
Specification
2. The disclosure is objected to because of the following:
In Tables 1, 3 and 5, for Leaf Morphology, it is unclear what “Type 2” denotes.
Applicant’s Traversals
Applicant traverses that a person of skill in the art would have knowledge and access to International Plant Genetic Resources Institute (IPGRI) (1996) Descriptors for tomato (Lycopersicon spp.). International Plant Genetic Resources Institute 44 p. (https://cgspace.cgiar.org/items/ff851561-dc94-4318-bbcb-6945130277f2), where a "Type 2" leaf is clearly illustrated on pages 25-26 (a copy of which is provided herewith as Exhibit A).
Response to Applicant’s Traversals
Applicant’s traversal is unpersuasive because the information necessary to clarify “Type 2” leaf morphology as found at the IPGRI website is not incorporated by reference in the specification. It is suggested Applicant amends the specification and adds the explanation for Type 2 leaf in parentheses next to the “Type 2” recitation.
Claim Objections
3. Claims 17 and 18 are objected to because of the following:
In claim 17(a), the first recitation of “of hybrid tomato variety” should be deleted because it is redundant.
Dependent claim 18 is included.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(a)
4. Claim 12 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
With regard to claim 12, the tissue culture of claim 11 encompasses pollen and anther haploid cells. The haploid cells are formed during meiosis when the diploid genome segregates during sexual hybridization. Variety E15M43069 is a hybrid, whereby its genome is heterologous at every locus. The tomato genome has about 35,000 genes (US Pub. No. 20240415127 (previously cited), [0002]). When its diploid genome segregates to form haploid cells, it is highly unpredictable which combination of alleles from each of the 35,000 genes are present in the haploid cells. There is no disclosure as to the genetic makeup of these haploid cells and how they can be used to produce a plant expressing all of the physiological and morphological characteristics of hybrid variety E15M43069. Applicant has no working examples and provides no guidance as how the anther and pollen cells can produce a plant having all the physiological and morphological characteristics of hybrid variety E15M43069. Accordingly, claim 12 is not enabled as commensurate in scope with the claims without undue experimentation.
Applicant’s Traversals
Applicant traverses that claim 12 does not recite tissue culture from any source, but rather tissue culture regenerated from cells or protoplasts specifically, physically connected with the physical plant of the claims, and the specification provides ample examples from the literature that would be well within the scientific expertise of a skilled person in the art, see e.g., paragraphs [0081]-[0082] of the present specification.
Response to Applicant’s Traversals
Applicant’s traversals have been considered but are deemed unpersuasive for the following reasons. Pollen and anther haploid cells are inherently part of the plant (claim 11) and are physically connected with the physical plant. Neither the state of the art to date nor Applicant’s disclosure teaches how a haploid cell, such as anther and pollen, can produce a plant having all the morphological and physiological characteristics of hybrid variety E15M43069. Paragraphs [0081]-[0082] do not teach how a haploid cell can produce a plant having all the morphological and physiological characteristics of hybrid variety E15M43069. Even if the chromosome number of the haploid cell is doubled, the morphological and physiological characteristics resulting from two homozygous recessive alleles, aa, would not be the same as two heterozygous Aa alleles present in hybrid variety E15M43069 due to the appearance of dominant and recessive genes. Accordingly, the rejection is maintained.
5. Claims 1-19 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.
35 USC 112 (a) states “The specification shall contain a written description of the invention” (emphasis added). In evaluating written description, the threshold question is: what is an adequate written description? This is question of fact that is evaluated by the factfinder (examiner). MPEP 2163.04 clearly states that “The inquiry into whether the description requirement is met must be determined on a case-by-case basis and is a question of fact. In re Wertheim, 541 F.2d 257, 262, 191 USPQ 90, 96 (CCPA 1976).”
The instant invention is a new tomato hybrid variety (E15M43069). So, the examiner will evaluate what is an adequate written description for a new tomato hybrid. In reviewing this question of fact, the examiner analyzes how plant varieties are evaluated in the public domain. The review concludes that generally the minimum requirements for an adequate description of a new plant variety are a trait table and genetic information (via a breeding history). In reviewing Applicant’s specification, there is a phenotypic description of hybrid variety E15M43069 in Tables 1 and 2. However, there is no accompanying breeding history in the specification for the claimed hybrid variety. Because the specification lacks a breeding history and that breeding history is part of the minimum description of a plant variety, Applicant has not fulfilled the requirement of 35 USC 112(a) to provide a written description in the specification. The Office’s reasonable basis for challenging the adequacy of written description is supported by a review of the following:
With regard to Plant Patents, MPEP 1605 states that a complete detailed description of a plant includes “the origin or parentage”.
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)).
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)).
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. As seen in Ex Parte C and Ex Parte McGowen, a trait table is insufficient to differentiate varieties by itself.
It has been long established that intraline 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 lines 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 line 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 line. (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.
The above factual evidence provides a reasonable basis that a breeding history is necessary written description. With this information the examiner has met the initial burden of presenting by a preponderance of evidence why a person of ordinary skill in the art would not recognize in Applicant’s disclosure a description of the invention defined by the claims. (See MPEP 2163.04). Importantly, it should be noted that the citations above are not referenced for legal authority. The legal authority relied by the examiner is the 35 USC 112(a) statute. The citations are presented to support the finding of fact that a breeding history is necessary for the adequate description of a plant variety.
Although not directly relied upon for the above written description position, a complete written description additionally helps drive examination and help with infringement verification.
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).
The breeding history aids 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 variations of a variety. A specification devoid of a complete breeding history hampers the public’s ability to resolve infringement analysis with plants already in the prior art as well as plants that have yet to be patented. Because the instant specification lacks a complete breeding history, the public will not be able to fully resolve questions of infringement. Since the breeding history, including the parents of the claimed variety, is not known to the public, the public could only rely on the phenotypes of the claimed plants for assessing potential infringement.
Thus, an application that does not clearly describe the breeding history does not provide an adequate written description of the invention. An adequate written description is essential to preclude the issuance of a patent that would otherwise issue due to Applicant’s omission of critical information from the specification.
To overcome this rejection, Applicant must amend the specification/drawing to provide the breeding history used to develop the instant variety. When identifying the breeding history, Applicant should identify any and all other potential names for all parental lines utilized in the development of the instant variety and all other potential names for the claimed variety. 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 line). If there any patent applications or patents in which sibs or parents of the instant plant are claimed, the serial numbers and names of the sibs or parents should be disclosed. This information can be submitted in an Information Disclosure Statement with a notation of the relevancy to the instant application or as information submitted as described in MPEP 724 (e.g., trade secret, proprietary, and Protective Order).
The claims indicate seeds representative of hybrid tomato E15M43069 are deposited. The claims are not directed to the deposited seeds or plants grown therefrom. Neither the specification nor the claims indicates that the claimed seed is genetically identical to the deposited seeds. When two inbred parents are crossed, one skilled in the art would reasonably expect to obtain a population of progeny plants that shares most of the phenotypic characteristics but are not necessarily genetically identical due to naturally-occurring genetic and environmental factors. Thus, the recitation of “E15M43069” in the claims is understood by the Office to encompass a genus of seeds/plants that are not are not genotypically identical. Additionally, paragraph [0078] states “When the terms “tomato plant”, “hybrid”, “cultivar” or “tomato line” are used in the context of the present disclosure, this also includes any single gene conversions of that variety.” This statement indicates that the claimed genus of plants do not necessarily have all the morphological and physiological characteristics of hybrid variety E15M43069 as disclosed in the specification. In fact, the specification goes on to state that the claimed plant has “essentially all of the desired morphological and physiological characteristics” of a variety [0078], whereby “essentially” and “desired” are not defined. Furthermore, Applicant acknowledges these characteristics are influenced by environmental conditions [0060]. The claims encompass a genus of plants that do not have the same genotype or phenotype, and the specification is silent with regard to the breeding history of hybrid variety E15M43069, including the parent plants used to produce the claimed hybrid variety and their public availability. It should be noted that Applicant does not provide marker information to distinguish the claimed genus of plants from other plants 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 plants from one another.
Applicant’s disclosure is insufficient because it does not address the issues set forth above.
Correction is required.
Applicant’s Traversals
Applicant traverses primarily the following: (1) The disclosure of the specification and deposit satisfy the written description requirement. (2) There is no requirement in the rules or statute that the specification must contain a complete breeding history. (3) The requirement for additional information should be made under 37 CFR 1.105(a)(1) and not a demand to rewrite the specification. (4) In Ex parte C, the Board held that “While the examiner may want to possess additional information regarding the inventive process, in this case the inheritable characteristics of parent species of plants and the particular procedure used to select for the claimed plant, in order to carry out a thorough examination, there is nothing in the statute which commands its inclusion in the specification.” (5) In Enzo, the genome of the deposited variety is described in the instant specification by reference to its deposit. (6) There are many analytical methods available to evaluate a new plant variety, such as genotypic analyses. (7) In Inari, the Board found that “[by] depositing the seeds, Patent owner is making the genetic sequence (genotype) of [variety] available”. (8) The written description requirement does not require that the specification discloses a complete breeding history. (9) MPEP 2163(I) does not require inclusion of a breeding history in the specification to meet the written description requirement. (10) It had not been the Office’s position that disclosure of the variety’s breeding history in the specification was required to meet the written description requirement. (11) The Office wrongly applies Plant Patent Practice (MPEP 1605) as well as Plant Variety Protection {PV} and International Union for the Protection of New Varieties of Plants (UPOV) requirements, all of which are legally irrelevant to examination of utility patents.
Response to Applicant’s Traversals
Applicant’s traversals have been 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. The claims indicate seeds representative of hybrid tomato E15M43069 are deposited. This is not the same as “A hybrid tomato seed designated as ‘E15M43069’ having been deposited under NCIMB Accession Number 44363.” That is, the claimed seeds are not required to be genetically identical to the deposited seeds. In fact, the specification encompasses plants having essentially all of the physiological and morphological characteristics of a plant produced by growing ‘E15M43069’ tomato seed having NCIMB Accession No. 44363 ([0009], [0043]). The specification acknowledges that the observed traits will vary due to environmental influence [0060]. The specification indicates the traits in Table 1 are exemplary and is based on observations taken in greenhouses located in Pijnacker, Netherlands [0061]. Thus, the recitation of “E15M43069” in the claims encompasses a genus of seeds/plants that are not are not genotypically identical to the deposit or phenotypically identical to the traits shown in the tables. No other information, such as genetic markers, is disclosed for the claimed genus.
With regard to traversal (1), the disclosure of the specification and deposit would satisfy the written description requirement IF the claimed seed / plant has all the traits set forth in the specification and is genetically identical to the deposit. It is clear from the claim language (“representative”), and the specification language (“essentially all”, “exemplary”) that Applicant does not intend to be limited to the genetics of the deposited seeds or the disclosed traits.
With regard to traversals (2) and (8), 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 the tables. 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 (3), 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, such as a Trade Secret submission in response to a 37 CFR 1.105(a)(1) request, cannot satisfy this statutory requirement because said submission is not part of the specification.
With regard to traversal (4), 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. Because 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 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).
With regard to traversal (5), in contrast to Enzo, Applicant is claiming a genus of seeds / plants that are not required to be genetically or phenotypically identical to the deposited seeds. The claims of Enzo do not have the “representative sample” language.
With regard to traversals (6) and (7), the specification does not disclose any genotypic data, such as polymorphisms and genetic markers, to distinguish the claimed variety from other varieties 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 traversal (9), it 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 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) for the claimed variety.
With regard to traversal (10), an Office position cannot disregard or override the statute set forth under 35 USC 112(a). Moreover, every case is determined on its own merits. Given the facts disclosed in the instant application, the Office concluded that the minimum description is the combination of the phenotype and genotype (breeding history) for the claimed variety.
With regard to traversal (11), 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 variety. 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.
6. Claims 3, 4, 7 and 9-11 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 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.
Claims 3, 4, 7 and 10 encompass an F1 progeny embryo and seed cell of hybrid tomato E15M43069. The genome of hybrid tomato E15M43069 is heterologous at every locus. When hybrid tomato E15M43069 is crossed with an unknown parent, it is unpredictable what genetic material its F1 progenies would inherit. The specification does not disclose a representative number of F1 progenies of hybrid tomato E15M43069 to allow one skilled in the art to predict the genetic makeup or physiological and morphological characteristics of the claimed F1 progenies. No identifying characteristics are set forth for the F1 progenies. There are insufficient relevant identifying characteristics to allow one skilled in the art to predictably determine the genomic structure or morphological and physiological characteristics of the claimed F1 progenies, absent further guidance. Accordingly, the claimed plant part and protoplast encompassing embryo and seed cells of hybrid tomato E15M43069 lack adequate written description.
With regard to claims 3, 4, 7 and 9-11, which encompass a pollen, pollen grain, anther and ovule (contain haploid cells), these claims lack adequate written description because Applicant is claiming haploid cells of hybrid tomato E15M43069. The genome of hybrid tomato E15M43069 is heterologous at every locus. During meiosis to produce the haploid cells, it is unpredictable which reassortment of dominant and recessive alleles of hybrid tomato E15M43069 would be present in the haploid cells. One skilled in the art cannot predict the genetic makeup of the claimed pollen, pollen grain, anther and ovule, or the morphological and physiological characteristics of a plant produced from these haploid cells. Accordingly, the claimed pollen, pollen grain, anther and ovule, and claims that encompass haploid cells, are not adequately described.
For the above reasons, there is a lack of adequate description to inform a skilled artisan that Applicant was in possession of the claimed invention at the time of filing. See https://www.uspto.gov/sites/default/files/web/menu/written.pdf.
Applicant’s traversals
Applicant traverses primarily that the claims recite parts that are physically connected with the claimed plant.
Response to Applicant’s traversals
Applicant’s traversals have been considered but are deemed unpersuasive for the following reasons. The plant part of claim 3 encompasses F1 progeny seed and F1 embryo that are inherently part of the plant and are physically connected to the plant. However, the seed and embryo on said plant are produced from hybridization of a plant of hybrid variety E15M43069 with an undisclosed plant. The seed and embryo present on the plant of hybrid variety E15M43069 have only half of the hybrid genome of variety E15M43069, the other half being from an undisclosed plant, and would produce a plant having significantly different morphological and physiological characteristics from hybrid variety E15M43069. However, it is not known what these characteristics are. Due to the reassortment of the hybrid genome of variety E15M43069 (the first parent plant), and no genotypic or phenotypic information for the second parent plant, it is highly unpredictable what genotypic or phenotypic characteristics said seed and embryo have. Accordingly, the seed and embryo cells present on the plant lack adequate written description. Similarly, the anther, pollen grain and ovule present on a plant of hybrid variety E15M43069 have only half of the genome of said plant. Because hybrid variety E15M43069 is heterologous at every allele, it is unpredictable what combination of dominant and recessive alleles from the hybrid genome is present in each anther, pollen grain and ovule. None of the disclosed characteristics in the specification describes the morphological and physiological characteristics of an ovule, a pollen grain or an anther of hybrid variety E15M43069. While an inbred plant has two identical copies of each chromosome, hybrid variety E15M43069 does not. The deposit of seeds of tomato hybrid variety E15M43069 is not representative of these haploid cells because the claimed haploid cells are not required to be identical to the haploid cells present in the deposit. In fact, the haploid cells of the seeds in the deposit population, when grown into plants, are genetically and phenotypically distinct from each other. It is unpredictable which combination of dominant and recessive alleles are present in each haploid cell. Thus, the haploid anther, pollen grain and ovule cells present on a plant of hybrid variety E15M43069 lacks adequate written description.
MPEP 2163(I) states “a showing of possession alone does not cure the lack of a written description”. In the instant application, no information whatsoever is disclosed for the claimed F1 progeny seed/embryo or haploid anther, pollen grain and ovule of hybrid variety E15M43069. Accordingly, the rejection is maintained.
Conclusion
7. No claim is allowed.
8. 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.
9. 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 on M-F 8am-5pm.
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, 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
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