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 July 10, 2026. 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All previous rejections not set forth below have been withdrawn.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.
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 line (PSQ-9Z21-1002). So, the examiner will evaluate what is an adequate written description for a new tomato line. 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 line PSQ-9Z21-1002 in Table 1. However, there is no accompanying breeding history in the specification for the claimed line. 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 line, 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 line. 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 line and all other potential names for the claimed line. 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 are 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 (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).
In the instant application, Applicant does not disclose the breeding history for the claimed line in the Specification. In a separate communication (Transmittal Letter) filed June 10, 2024, Applicant discloses tomato line PSQ-9Z21-1002 is a substantially homozygous, proprietary line developed from crossing substantially homozygous, proprietary lines 14PW1177-3:@a and PSQ-176-HUSH, followed by pedigree selection until the F8 generation. The information provided in the Transmittal Letter should be set forth in the specification, because said Transmittal Letter is not part of the Specification and cannot provide the written description required to be in the Specification. Thus, the breeding history for the claimed line as disclosed in the Specification is incomplete. Moreover, the claims recite that the deposited seeds are “a [representative] sample” of line PSQ-9Z21-1002. The claims are not directed to the deposited seeds or plants grown therefrom. Paragraph [0027] states “A small percentage of variants can occur within commercially acceptable limits for almost any characteristic during the course of repeated multiplications.” Table 1 indicates that the disclosed phenotypic traits “are typical values. Values may vary due to environment. Values that are substantially equivalent are within the scope of the invention.” Additionally, paragraph [0035] states “an occasional variant trait … might arise during backcrossing, introduction of a transgene, or application of a genetic engineering technique.” Thus, the claims are directed to a genus of tomato plants and seeds that are genotypically and phenotypically different from the deposit and have different traits from those disclosed in the specification. Therefore, the question is not whether one skilled in the art can distinguish the claimed plant from other plants, but whether one skilled in the art can distinguish the genus of claimed plants from other plants. The disclosure of the parents, i.e., breeding history, used to produce the claimed genus is an essential component for determining the patentability of the claimed genus. 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. Moreover, claims 23-25 would preclude anyone from performing a marker analysis for genotyping the plant. Given these differences, the complete breeding history for producing the claimed line in the Specification is deemed material for patentability.
Correction is required.
Applicant’s Traversals
Applicant traverses primarily the following: (1) The requirement of a breeding history rests on standards from Plant Patent practice and PVP/UPOV regimes that are inapplicable to utility patent examination. (2) The specification provides the genotype and phenotype of the claimed plants. (3) The Declaration of Vivek Sharma states “A fundamental principle of genetics in the development of new plant varieties is that no two plants produced by the same cross involving different parents will have an identical genotype…For this reason, the breeding history does not provide a person of ordinary skill in the art with the genotype of the line. The genotype of the line can only be provided by access to the line itself, such as by access to the deposit of a representative sample of seed of the line.” (4) MPEP 2163 states that the written description may be satisfied by reference to a deposit for a biological material. (5) The Federal Circuit has long approved the use of deposits to satisfy both written description and enablement for biological subject matter (Enzo Biochem Inc. v. Gen-Probe, Inc. and In re Lunkak), a person of ordinary skill in the art could determine the DNA sequence based on the identification of the genus and publicly available biological deposits referenced in the patent specification (Monsanto Co. v. Scruggs), and adequate written description requires that the specification “reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter” (Ariad Pharms., Inc. v. Eli Lilly & Co. (all citations omitted)). (6) The claimed subject matter is directed to plants, seeds, and plant parts comprising at least a first set of chromosomes of tomato line PSQ-9Z21-1002, not the process by which the tomato line was developed. (7) The holding in Ex Parte C (citation omitted) is that the breeding history of a soybean variety was not necessary to meet the written description requirement when the specification and deposit otherwise satisfied §112. (8) Inari Agriculture, Inc. v. Pioneer Hi-Bred International, Inc. (citation omitted) (Exhibit A) states that “by depositing the seeds, Patent Owner is making the genetic sequence (genotype) of [variety] available,” and that the “genetic make-up is described in the specification via the seed deposit.” (9) In response to Under Secretary Jennifer Moffitt of the USDA request that the USPTO “review existing guidance and, if necessary, create additional guidance to determine under which circumstances breeding histories or pedigrees back to known and publicly available parents should be required in an application’s original disclosure to satisfy 35 USC §112 for utility patents pertaining to plant varieties and traits” (October 8, 2024, Exhibit B), Acting Director Derrick Brent of the USPTO stated that “[t]he USPTO has reviewed its existing guidance and concluded that additional guidance relating to breeding histories and/or deposit of biological materials is not needed at this time” and “[i]n those instances in which a deposit was required to satisfy §112, the public may access the patent protected material from the applicable depository. It is from that deposit that the public would be enabled to make and use the claimed invention as required by §112” (January 14, 2025, Exhibit C). (10) The Action’s reliance on Plant Patent disclosure practices, USDA Plant Variety Protection practices and UPOV essentially derived variety guidance is legally irrelevant. (11) The Action has not cited a single decision holding that a breeding history is a mandatory component of written description under §112(a) for a utility patent claiming a plant variety. (12) The Declaration of Sharma states “A person of ordinary skill in the art can access the deposited seed, extract DNA, and determine a genetic marker profile or the complete genotype using routine molecular techniques such as SNP marker analysis, SSR analysis, or whole-genome sequencing.” (13) Breeding histories were considered in Ex Parte C and Ex Parte McGowen is an inquiry under §103, and Ex Parte C specifically recognizes that the Office may not require that “additional information regarding the inventive process” be included in the specification when §112 is otherwise satisfied. (14) The Declaration of Sharma states “Haun et al. and Groβkinsky et al. are asserted to teach that intracultivar heterogeneity is a consequence of segregation, recombination, DNA transposition, epigenetic processes, spontaneous mutations, and environmental variation. A breeding history provides no information concerning any of these processes.” (15) A Transmittal Letter filed on June 10, 2024 in the instant application discloses the breeding history of tomato line PSQ-9Z21-1002. (16) Exhibit D identifies that 28 of 30 utility patents directed to tomato varieties issued between March 31, 2020 and June 10, 2025 do not have a breeding history, and there have been no changes in the statute, rules, or judicial precedent during this time frame. (17) The Specification provides description sufficient to permit examination, and the present action used the morphological and physiological characteristics found in the present specification to identify the closest prior art and distinguish the claimed line from the prior art. (18) The Specification aids in resolving infringement because the deposit makes the genotype and phenotype of the claimed line available for analysis, and a breeding history cannot assist in this determination. (19) All claims meet the written description requirement because the specification provides a deposit of sample of seed of tomato line PS-9Z21-1002 and variety description information for the line.
Reply to Applicant’s Traversals
Applicant’s traversals have been considered but are deemed unpersuasive for the following reasons. With regard to traversal (1), the legal authority relied by the examiner is the 35 USC 112(a) statute. Case laws, Plant Patents, PVP, UPOV, and scientific publications are presented to support the finding of fact that a breeding history is necessary for an adequate description of a plant variety.
With regard to traversal (2), the specification does not provide both the genotype and phenotype of the claimed plants. For the genotype of the inbred line, the claims recite “a [representative] sample” has been deposited, and the specification states that genetic variants, which are genetically distinct from the deposit, are encompassed by the claims. Thus, the claimed seeds and plants grown therefrom are genetically distinct from the sample provided in the deposit. For the phenotype of the inbred, the specification states that the disclosed characteristics are “typical values” for the inbred line and “values that are substantially equivalent are within the scope of the invention”. Therefore, for the inbred line, Applicant is claiming a genus of seeds/plants that are genotypically and phenotypically different from the deposit and the trait table. For the genotype of the hybrid, said hybrid has one set of chromosomes of the genus of the inbred line, and no phenotypic traits are disclosed for the hybrid. Applicant states that the genetic complements are readily identifiable by genetic marker analysis. However, no marker or polymorphism is disclosed for the inbred or the hybrid, and any attempt by one skilled in the art to do so would infringe on Applicant’s claimed invention (claims 23-25). Applicant states that the deposit provides the inherent phenotypic characteristics of the line, and the specification provides detailed morphological and physiological characteristics in Table 1. However, there is no disclosure of markers or genes that can be correlated with the phenotypic characteristics of the line, and no morphological and physiological characteristics are provided for a plant comprising a first set of the chromosomes of tomato line PSQ-9Z21-1002.
With regard to traversal (3), the purpose of the breeding history is not solely to provide the genotype of the line, but also to allow one skilled in the art to ascertain whether differences in traits are attributable to occasional variant traits that arise during backcrossing or direct introduction of a transgene, natural variations in plants caused by genetics and environment, grader subjectivity, linkage drag during backcrossing, donor plant traits and/or statistical insignificance. Additionally, it allows one skilled in the art to determine whether an observed morphological and physiological difference is unexpected and practically significant. As stated in the Declaration, no two plants produced by the same cross involving different parents will have an identical genotype. This is further evidence that a breeding history is necessary to determine whether these differences rise to the level of patentable distinctiveness.
With regard to traversal (4), if a deposit alone satisfies the written description requirement, then there is no need to provide any description whatsoever in the specification regarding the morphological and physiological characteristics of the line. However, the statute 35 USC 112 (a) clearly states “The specification shall contain a written description of the invention” (emphasis added).
With regard to traversal (5), in contrast to the cited Federal Circuit holdings, the genome of the claimed line is not accessible to the public for distinguishing Applicant’s line from other plants, and one skilled in the art could not determine the DNA sequence of the claimed genus without infringing Applicant’s claimed invention (claims 23-25). Applicant is claiming a genus of plants that is genotypically and phenotypically distinct from the deposit and the trait table. As tomato plants share many of the same characteristics, the breeding history is an essential factor to consider when distinguish the claimed line from other varieties.
With regard to traversal (6), the breeding history is part of the minimum description of a plant variety. See Office’s reply to traversal (3). If two plants have most of the same morphological and physiological characteristics, and they are siblings of each other, differences between them may be accepted variations within a population. Only a breeding history would disclose how two plants are related / unrelated to each other.
With regard to traversal (7), 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) of the claimed line.
Traversal (8) has been addressed in the Office’s replies to traversals (2) and (5) above.
With regard to traversal (9), the statement “additional guidance relating to breeding histories and/or deposit of biological materials is not needed at this time” is not the same as “breeding histories and/or deposit of biological material is not needed at this time”. The statute 35 USC 112(a) encompasses both deposit requirements and written description requirements. The communication of January 14, 2025 does not address the requirement of an adequate written description in the Specification as specified under the statute. Furthermore, the communication was issued with the understanding that the public would be able access the deposited material to make and use the claimed invention, which the public cannot without infringing the claimed invention. Again, it should be noted that Applicant is claiming a genus of plants that are genotypically and phenotypically different from the deposit and from the trait table, and no phenotypic traits are disclosed for a plant having one set of chromosomes of tomato line PSQ-9Z21-1002.
Traversal (10) has been addressed in the Office’s reply to traversal (1).
In regard to traversal (11), the threshold question is: what is an adequate written description under 35 USC 112(a)? 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).” 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).
Traversal (12) has been addressed in the Office’s replies to traversals (2) and (5) above.
Traversal (13) has been addressed in the Office’s reply to traversal (7) above. The disclosure of a breeding history may result in a rejection under §103, but the requirement of said disclosure is under §1112(a). Ex Parte C states that the Office may not require “additional information regarding the inventive process” to help the examiner carry out a thorough examination. However, this information is necessary to satisfy §112(a).
With regard to traversal (14), 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. Applicant is claiming a genus of plants that are genotypically and phenotypically different from the deposit and from the trait table. The breeding history is another factor for one skilled in the art to consider in determining whether or not the observed phenotypic variations within a cultivar are “substantially equivalent”, which are “within the scope of the invention” (see notation at the bottom of Applicant’s trait table).
With regard to traversal (15), the Transmittal Letter is not part of the Specification and cannot provide the written description required to be in the Specification.
With regard to traversal (16), Applicant is invited to review utility patents within the past year to determine how many applications directed to cultivars issued without a breeding history. Many factors are considered in determining the necessity of a breeding history in the specification. New cultivars are continually being developed and progressively being added to an already crowded field. Moreover, tomato plants share many of the same traits. The claims encompass a genus of tomato plants that are not genetically identical to the deposit, and do not necessarily have all the phenotypic traits disclosed in the specification. No genetic markers are disclosed to correlate a particular trait to a genetic locus in the claimed line/cultivar/variety. Case laws, Plant Patents, PVP, UPOV, and scientific publications support that a breeding history is necessary for an adequate description of a plant variety. In consideration of at least these factors, the Office made a finding of fact that a breeding history is necessary to comply with §112(a). Moreover, one of the criteria in determining compliance with §1112(a) is the state of the prior art when the application was filed, which changes day to day and with each new filing. It is illogical and impractical to expect a new statute, rule, or judicial decision to address or provide notice for every nuance of this ever-changing state of the prior art.
With regard to traversal (17), Applicant is invited to review the search notes that accompany the Office action. The search notes are not merely limited to the morphological and physiological characteristics found in the specification as Applicant has alleged. The search notes also include the breeding history provided in the Transmittal Letter filed June 10, 2024. Upon review of the Transmittal Letter, the Office made a determination that the information disclosed in the Transmittal Letter is a relevant part of the description of the claimed line and should be included in the Specification.
Traversals (18) and (19) have been addressed in the Office’s replies to traversals (2), (3), (5) and (6) above.
Accordingly, the rejection is maintained.
3. Claims 17 and 18 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.
Additionally, with regard to claims 17 and 18, the claimed plant further comprising a single locus conversion lacks adequate written description for the following reasons. Initially, it should be noted that the claimed plant encompasses a hybrid of line PSQ-9Z21-1002 further comprising a single locus conversion. The claims are not directed to an inbred plant of line PSQ-9Z21-1002 further comprising a single locus conversion and otherwise having all the morphological and physiological characteristics of an inbred plant of line PSQ-9Z21-1002. Thus, prior to producing the claimed plants, an inbred plant of line PSQ-9Z21-1002 was crossed with an undisclosed plant to produce a hybrid plant having undisclosed morphological and physiological characteristics. Said hybrid plant having undisclosed morphological and physiological characteristics is then outcrossed with additional undisclosed plant(s) to introduce the single locus conversion(s) before being backcrossed to a hybrid of line PSQ-9Z21-1002. Because it is not known what morphological and physiological characteristics the hybrid plant has prior to the outcrossing(s), the morphological and physiological characteristics of its progenies cannot be predictably determined. Moreover, paragraph [0023] states that the words “a” and “an” denote “one or more,” unless specifically denoted otherwise. Therefore, the claims encompass the incorporation of multiple single locus conversions. Paragraph [0008] states that a single locus conversion includes one or more site-specific changes to the plant genome and may comprise one or more genes or nucleotides integrated or mutated at a single chromosomal location. However, because it is not known what morphological and physiological characteristics a hybrid of line PSQ-9Z21-1002 has prior to the incorporation of site-specific changes comprising one or more genes, additional genomic modifications to said hybrid would not produce a plant that can be adequate described genotypically or phenotypically. Applicant has no working example of a plant comprising at least a first set of chromosomes of tomato line PSQ-9Z21-1002 further comprising a single locus conversion. Thus, the claimed plant comprising at least a first set of the chromosomes of tomato line PSQ-9Z21-1002 further comprising a single locus conversion lacks adequate written description.
Accordingly, one skilled in the art would not have recognized Applicant was in possession of the claimed invention at the time of filing. See Written Description Guidelines, Revision 1, March 25, 2008, published online at http://www.uspto.gov/web/menu/written/pdf.
Applicant’s Traversals
Applicant traverses primarily the following: (1) Paragraph [0090] defines the term “single locus conversion”. (2) The specification provides detailed exemplary methods for producing the claimed plants comprising at least a first set of chromosomes of the line and further comprising a single locus conversion in paragraphs [0029]-[0061]. (3) Written description does not require an applicant to “describe exactly the subject matter claimed, [instead] the description must clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed”. (4) A person of ordinary skill in the art would understand that all plants having at least a first set of chromosomes of tomato line PSQ-9Z21-1002, including plants further comprising a single locus conversion, will have the same genetic contribution of tomato line PSQ-9Z21-1002 as half of their genetic material, save the possibility of the rare spontaneous mutation or undetected segregating locus. (5) The entire genetic contribution of tomato line PSQ-9Z21-1002 is described in the specification by way of deposit of seed of the line. (6) All plants having at least a first set of the chromosomes of tomato line PSQ-9Z21-1002, including plants further comprising a single locus conversion, will share the haploid genetic complement received from the line, which are readily identifiable and represent a description of the concrete and identifiable structural characteristics defining the claimed plant and distinguishing it from other plants..
Reply to Applicant’s Traversals
Applicant’s traversals have been considered but are deemed unpersuasive for the following reasons. With regard to traversal (1), the starting material, “a tomato plant comprising at least a first set of the chromosomes of tomato line PSQ-9Z21-1002”, encompasses a hybrid, whereby its genome is heterozygous at every locus. Paragraph [0090] defines a single locus converted plant as “Plants which are developed by a plant breeding technique called backcrossing or genetic engineering of a locus, wherein essentially all of the morphological and physiological characteristics of a tomato variety are recovered in addition to the characteristics of the single locus.” This definition is understood by the Office to include at least one outcrossing to a genetically different plant to introduce the single locus conversion before being backcrossed to the hybrid parent plant. However, since the hybrid plant is not required to have any of the morphological and physiological characteristics of tomato line PSQ-9Z21-1002, outcrossing said hybrid parent with a genetically different plant to introduce the single locus conversion then backcrossing to the hybrid parent would not produce a plant having all the morphological and physiological characteristics of tomato line PSQ-9Z21-1002, because the hybrid parent does not have all the morphological and physiological characteristics of tomato line PSQ-9Z21-1002 to begin with. Because the morphological and physiological characteristics of a plant comprising at least a first set of the chromosomes of tomato line PSQ-9Z21-1002 is not known, the morphological and physiological characteristics of said plant further comprising a single locus conversion cannot be determined.
With regard to traversal (2), none of the methods set forth in paragraphs [0029]-[0061] allows one skilled in the art to predict even one morphological and physiological characteristic of tomato line PSQ-9Z21-1002 that is retained in the claimed plant, because the starting material, a plant comprising at least a first set of the chromosomes of tomato line PSQ-9Z21-1002, is not required to have any of the morphological and physiological characteristics of tomato line PSQ-9Z21-1002.
With regard to traversal (3), as neither the genotype nor the phenotype of the claimed plant is disclosed or can be determined, a person of ordinary skill in the art would not recognize that Applicant is in possession of what is claimed.
With regard to traversal (4), while a hybrid of tomato line PSQ-9Z21-1002 has half the genetic contribution of tomato line PSQ-9Z21-1002, a progeny obtained from outcrossing said hybrid with a genetically different plant to introduce the single locus does not have half the genetic contribution of tomato line PSQ-9Z21-1002, even if said progeny is backcrossed to the hybrid parent.
With regard to traversal (5), Applicant’s traversal is not on point because the claimed plant comprising at least a first set of the chromosomes of tomato line PSQ-9Z21-1002 further comprising a single locus conversion is not deposited. The deposit does not allow one skilled in the art to determine the genotype or the phenotype of the claimed plant.
With regard to traversal (6), while the starting material has at least a first set of the chromosomes of tomato line PSQ-9Z21-1002, the claimed plant does not have at least half of the chromosomes of tomato line PSQ-9Z21-1002. Furthermore, from the definition provided in paragraph [0090], the claimed plant does not have essentially all of the morphological and physiological characteristics of tomato line PSQ-9Z21-1002 in addition to the characteristics of the single locus, because the starting material does not have essentially all of the morphological and physiological characteristics of tomato line PSQ-9Z21-1002. The claimed plant is not readily identifiable and does not represent a description of the concrete and identifiable structural characteristics that would distinguish said plant from other plants as Applicant has alleged.
Accordingly, the rejection is maintained.
Conclusion
4. No claim is allowed.
5. 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.
6. 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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/PHUONG T BUI/Primary Examiner, Art Unit 1663
