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 October 29, 2025. Claims 1-14 and 17-19 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All previous rejections not set forth below have been withdrawn.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 Table 1, 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 Specification does not reference IPGRI, and pages 25-26 do not illustrate Type 2 leaf. It is suggested Applicant amend the Specification and add the explanation for Type 2 leaf in parentheses next to the “Type 2” recitation.
Claim Rejections - 35 USC § 112(a)
3. Claim 11 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 11, the tissue culture of claim 10 encompasses pollen and anther haploid cells. The haploid cells are formed during meiosis when the diploid genome segregates during sexual hybridization. Variety E15C42785 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 E15C42785. 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 E15C42785. Accordingly, claim 11 is not enabled as commensurate in scope with the claims without undue experimentation.
Applicant’s Traversals
Applicant traverses that claim 11 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., paragraph [0068] of the present specification.
Response to Applicant’s Traversals
Applicant’s traversals have been considered but are deemed unpersuasive for the following reasons. 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 ‘E15C42785’. Paragraph [0068] does not teach how a haploid cell can produce a plant having all the morphological and physiological characteristics of hybrid variety ‘E15C42785’. 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 ‘E15C42785’ due to the appearance of dominant and recessive genes. Accordingly, the rejection is maintained.
4. Claims 1-14 and 17-19 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. The instant Specification fails to satisfy the written description requirement of 35 U.S.C. § 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 plant variety. Specifically, in claim 1, Applicant claims a new tomato plant variety. 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 shown in the specification. The instant application is silent or incomplete as to the breeding history used to produce the claimed plant variety.
The criticality of a breeding history in assessing the intellectual property rights of a plant is well recognized in the field of plant breeding. With regard to Plant Patents, MPEP 1605 states that a complete detailed description of a plant includes “the origin or parentage”. Other bodies that grant intellectual property protection for plant varieties require breeding information to evaluate whether protection should be granted to new varieties. A breeding history, including information about parentage and breeding methodology, is part of the requirements of Plant Variety Protection (PVP) applications. That information is used to “determine if development is sufficient to consider the variety new” (See “Applying for a Plant Variety Certificate of Protection”, 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. All other potential names for the claimed variety should also be set forth. 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 variety 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 and progenies of the instant variety). If there any patent applications or patents in which sibs, progenies or parents of the instant plant are claimed, the serial numbers and names of the sibs, progenies or parents should be disclosed. This information can be submitted in an Information Disclosure Statement (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).
Applicant’s disclosure is insufficient because it does not address the issues set forth above.
Correction is required.
Applicant’s Traversals
Applicant traverses primarily that Applicant has submitted the breeding history information as a Trade Secret to satisfy the examination requirements of the Office.
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”. A Trade Secret submission cannot satisfy this statutory requirement because said submission is not part of the specification. Accordingly, the rejection is maintained. It is suggested the Specification be amended to include the requested information.
5. Claims 3, 6 and 8-10 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, 6, and 9 encompass an F1 progeny embryo and seed cell of hybrid tomato E15C42785. The genome of hybrid tomato E15C42785 is heterologous at every locus. When hybrid tomato E15C42785 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 E15C42785 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 E15C42785 lack adequate written description.
With regard to claims 3, 6, 8 and 10, directed to a pollen, pollen grain, anther and ovule (contains haploid cells), these claims lack adequate written description because Applicant is claiming haploid cells of hybrid tomato E15C42785. The genome of hybrid tomato E15C42785 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 E15C42785 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 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 the plant of claim 2 encompasses F1 progeny seed and F1 embryo that are physically connected to the plant. However, the seed and embryo on said plant are produced from hybridization of a plant of hybrid variety E15C42785 with an undisclosed plant. The seed and embryo present on the plant of hybrid variety E15C42785 have only half of the hybrid genome of variety E15C42785, the other half being from an undisclosed plant, and would produce a plant having significantly different morphological and physiological characteristics from hybrid variety E15C42785. However, it is not known what these characteristics are. Due to the reassortment of the hybrid genome of variety E15C42785 (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 present on the plant lack adequate written description. Similarly, the anther, pollen grain and ovule present on a plant of hybrid variety E15C42785 have only half of the genome of said plant. Because hybrid variety E15C42785 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 E15C42785. While an inbred plant has two identical copies of each chromosome, hybrid variety E15C42785 does not. The deposit of seeds of tomato hybrid variety E15C42785 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 E15C42785 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 E15C42785. Accordingly, the rejection is maintained.
Conclusion
6. No claim is allowed.
7. 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.
8. 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