DETAILED ACTION
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 .
Information Disclosure Statement
The Information Disclosure Statements filed on 6/3/2025 have been entered and considered. Initialed copies of the form PTO-1449 are enclosed with this action.
Status of claims
Claims 1-27, filed 9/26/2024, are pending and examined in the office action.
Priority
Instant application 18897680, filed 9/26/2024, claims priority from Provisional Application 63676982, filed 07/30/2024, which is recognized.
Claim Rejections - 35 USC § 112
Enablement/Deposit
The following is a quotation of the first paragraph 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.
Claims 1-27 are rejected under 35 U.S.C. 112(a), 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.
Claims are drawn to a tomato plant comprising at least a first set of the chromosomes of tomato line FIR-YA22-9246 or tomato line FIS-YA18-2246V, a sample of seed of said lines having been deposited under NCMA Accession No. 202406011 and NCMA Accession No. 202406012, respectively, a seed producing the plant, plant part, tissue culture, method of using the plant, and more.
The tomato line FIR-YA22-9246 or FIS-YA18-2246V appears to be novel biological materials. Since the seed claimed is essential to the claimed invention, it must be obtainable by a repeatable method set forth in the specification or otherwise be readily available to the public. If a seed is not so obtainable or available, a deposit thereof may satisfy the requirements of 35 U.S.C. 112. The specification does not disclose a repeatable process to obtain the exact same seed in each occurrence and it is not apparent if such a seed is readily available to the public.
The examiner noticed that in the specification ([0095]): “A deposit of at least 625 seeds of tomato line FIR-YA22-9246 and of tomato line FIS-YA18-2246V, disclosed above and recited in the claims, has been made with the Provasoli-Guillard National Center for Marine Algac and Microbiota (NCMA), 60 Bigelow Drive, East Boothbay, Maine 04544, USA. The date of deposit for those deposited seeds of tomato line FIR-YA22-9246 and tomato line FIS-YA18-2246V is Jun. 26, 2024. The accession numbers for those deposited seeds of tomato line FIR-YA22-9246 and tomato line FIS-YA18-2246V are NCMA Accession No. 202406011 and NCMA Accession No. 202406012, respectively. Upon issuance of a patent, all restrictions upon the deposits will be removed, and the deposits are intended to meet all of the requirements of 37 C.F.R. §§ 1.801-1.809. The deposits have been accepted under the Budapest Treaty and will be maintained in the depositary for a period of 30 years, 5 years after the last request, or the effective life of the patent, whichever is longer, and will be replaced if necessary during that period”.
However, according to MPEP 2404.01, “The mere reference to a deposit or the biological material itself in any document or publication does not necessarily mean that the deposited biological material is readily available. Even a deposit made under the Budapest Treaty and referenced in a United States or foreign patent document would not necessarily meet the test for known and readily available unless the deposit was made under conditions that are consistent with those specified in these rules, including the provision that requires, with one possible exception (37 CFR 1.808(b)), that all restrictions on the accessibility be irrevocably removed by the applicant upon the granting of the patent. Ex parte Hildebrand, 15 USPQ2d 1662 (Bd. Pat. App. & Int. 1990)”.
In this case, the statement of “all restrictions on the accessibility be irrevocably removed” is missing in the specification. Without such statement, the deposit does not meet the requirement.
Additionally, there is no deposit receipt or any document from NCMA filed by the applicant.
A statement by an attorney of record over his or her signature and registration number, stating that the seeds will be irrevocably and without restriction or condition released to the public upon the issuance of a patent would address the issue raised herein.
Lacking written description
The following is a quotation of the first paragraph 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.
Claims 1-27 are rejected under 35 U.S.C 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The rejection is made because the specification fails to disclose the breeding history and parent lines of the instant tomato line FIR-YA22-9246, and the breeding history and parent lines of the instant tomato line FIS-YA18-2246V.
35 USC 112 (a) states that “The specification shall contain a written description of the invention”. 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 inventions are a new tomato line FIR-YA22-9246 and/or new tomato line FIS-YA18-2246V (and their F1 progeny SVTJ7542 in dependent claims).
Accordingly, the examiner will evaluate what is an adequate written description for new tomato lines. In reviewing this question of fact, the examiner analyzed how plant lines are evaluated in the public domain. The review concluded that generally the minimum requirements for an adequate description of a new plant variety has a trait table and genetic information (via a breeding history). In reviewing applicant’s specification there is a phenotypic description as is seen in table 1 (in pages 10-15). However, there is no accompanying breeding history in the specification. The examiners noticed that [0028] of the specification describes the breeding history of SVTJ7542. However, SVTJ7542 is merely claimed in dependent claims, and is a specific F1 progeny of FIR-YA22-9246 and FIS-YA18-2246V. The breeding histories of FIR-YA22-9246 and of FIS-YA18-2246V, either and both of which are instantly claimed, are missing in the specification.
Because the specification lacks a breeding history and that breeding history is part of the minimum description of a plant variety the 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 informed 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, (U)).
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 (V)).
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) (W) and Ex Parte McGowen Board Decision in Application 14/996,093, decided June 15, 2020 (X)). 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 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 (Y)) 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 (Z), 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 an applicant’s disclosure a description of the invention defined by the claims. (See MPEP 2163.04). Please note, the citations above are not for legal authority, the legal authority relied upon 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 to the adequate description of a plant.
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) 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 variation within a variety.
Moreover, 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 not yet been patented. Because the instant specification lacks the complete 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.
Furthermore, a breeding history particularly parent lines is essential to search siblings of instant plant to determine if there is/are any double patenting(s).
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, the applicant must amend the specification/drawing to provide the breeding history used to develop the instant cultivar. When identifying the breeding history, the applicant should identify any and all other potential names for all parental lines utilized in the development of the instant cultivar and all other potential names for the claimed cultivar. If the applicant’s breeding history uses proprietary cultivar names, the applicant should notate in the specification all other names of the proprietary cultivars, especially publicly disclosed or patented cultivar information. If the breeding history encompasses a locus conversion or a backcrossing process, the 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, the applicant should provide the breeding history of the parent line as well (i.e., grandparents). The 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.
The applicant is reminded that they have a duty to disclose information material to patentability. The 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 cultivar). 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 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).
Claims 10, 14, 16-18 are additionally rejected under 35 U.S.C. 112(a), as failing to comply with the written description requirement.
To claim a genus under the written description requirement, the applicant is required to describe a representative number of species to reflect the variation within the genus or structures sufficient to define the genus. The factors to be considered include disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, or any combinations thereof.
By court' s statement in Regents of the Univ. of Cal. v. Eli Lilly, 119 F.3d 1559, 1566, 43 USPQ2d 1398, 1404 (Fed. Cir. 1997), a written description of an invention “requires a precise definition, such as a structure, formula, or chemical name, of the claimed subject matter sufficient to distinguish it from other materials”; further, a written description of a claimed genus requires a description of a representative number of species of the claimed genus, and one of skill in the art should be able to “visualize or recognize the identity of the members of the genus”.
Regarding claim 10, the claim is broadly drawn to a genus of tomato plants having all of the physiological and morphological characteristics of the plant of claim 1.
By BRI, the claim is interpreted as to a genus of tomato plants having all the physiological and morphological characteristics of any plant in the genus of tomato plants of claim 1 (having a first set of the chromosome of either FIR-YA22-9246 or FIS-YA18-2246V, the second set of the chromosome is not specific, and is a genus of chromosomes). In another word, by BRI, the physiological and morphological characteristics is not of a (or two) particular species, is of any species of the genus.
According to the specification ([0028]), The parents of tomato hybrid SVTJ7542 are tomato line FIR-YA22-9246 and tomato line FIS-YA18-2246V. SVTJ7542 is the only described species of F1 progeny of the parents of FIR-YA22-9246 and FIS-YA18-2246V.
The specification only describes representative physiological and morphological characteristics of SVTJ7542, FIR-YA22-9246 and FIS-YA18-2246V (Table 1 in p10-15).
The specification does not describe physiological and morphological characteristics of the genus of pepper plants having all the physiological and morphological characteristics of the plant of claim 1. the specification does not describe physiological and morphological characteristics of any species other than of SVTJ7542, FIR-YA22-9246 or FIS-YA18-2246V.
Please note that SVTJ7542 (F1 progeny) has different physiological and morphological characteristics from that of either parent. For example, in average number of flowers in inflorescence, they are 9.2, 6.1, and 8.5; in leafy or "running" inflorescence, they are absent, occasional, and occasional; in mature fruit weight, they are 126.4 g, 216 g and 91.1 g; and so on.
In the art, one set of chromosomes does not fully determine the physiological and morphological characteristics of any organism. Trait genes can be dominant or recessive. For example, Foolad (Genome Mapping and Molecular Breeding of Tomato. International Journal of Plant Genomics, p1-52, 2007) teaches that cultivated tomatoes have dominant and recessive genes (p7, left col, 1st para to right col, 1st para; p18, left col, 2nd para; p31, right col, 1st para; p33, right col, 1st para). Foolad also teach that the genetic structures are diversified within the cultivated species (p11, left col, last para), and that in F1 hybrids, there are excessive variations including undesirable variations in traits/physiological and morphological characteristics (p14, right col, 1st para).
Hence, in the instant case, the second set of chromosomes is generic not specific, and the genes can be very different among the species. Hence, the tomato plants of claim 1 are heterologous in genetic structure; and hence, the physiological and morphological characteristics of the genus of plants are also heterologous (each species is different). Such heterologous physiological and morphological characteristics of the genus of plants have not been described in the specification.
According to Vas-Cath Inc. v. Mahurkar 1991 (CA FC) 19 USPQ2d 1111, 1115, which teaches that the purpose of the written description is for the purpose of warning an innocent purchaser, or other person using a machine, of his infringement of the patent; and at the same time, of taking from the inventor the means of practicing upon the credulity or the fears of other persons, by pretending that his invention is more than what it really is, or different from its ostensible objects, that the patentee is required to distinguish his invention in his specification. In this case, there is no way that a practitioner would be able to determine if any particular maize plant is infringing the instant claims, and therefore, the public has not been put on notice with a sufficient description of the claimed invention. (See Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 920-23, 69 USPQ2d 1886, 1890-93 (Fed. Cir. 2004)).
Regarding claim 14, the claim is broadly drawn to a genus of pepper plants produced by the method of claim 13.
Claim 11 recites a method comprising:
(a) utilizing as a recurrent parent the plant of claim 1 by crossing said plant with a donor plant that comprises a trait to produce F1 progeny;
(b) selecting an F1 progeny that comprises the trait;
(c) backcrossing the selected F1 progeny with a plant of the same pepper line used as the recurrent parent in step (a) to produce a backcross progeny;
(d) selecting a backcross progeny comprising the trait and otherwise comprising the morphological and physiological characteristics of the recurrent parent line used in step (a); and
(e) repeating steps (c) and (d) three or more times to produce a selected fourth or higher backcross progeny.
As analyzed above, SVTJ7542 comprises one set of chromosomes from either parent FIR-YA22-9246 or FIS-YA18-2246V.
Therefore, “the plant of claim 1” recited in claim 11 are or encompass F1 progenies of FIR-YA22-9246 or FIS-YA18-2246V.
Accordingly, the “F1 progeny” recited in claim in step (a) of claim 13 is actually F2 progeny regarding FIR-YA22-9246 or FIS-YA18-2246V (of claim 1). Steps (c) to (e) produces progenies beyond F2 generation.
Thus, a genus of pepper plants produced by the method of claim 13 recited in claim 14, are or encompass progenies of FIR-YA22-9246 or FIS-YA18-2246V of F2 generation and beyond.
The specification does not describe any F2 progeny of FIR-YA22-9246 or FIS-YA18-2246V, inbred, or hybrid, the physiological and morphological characteristics thereof, not to mention the common structure feature of F2 progenies and beyond. In fact, SVTJ7542 is the only described F1 progeny of FIR-YA22-9246 or FIS-YA18-2246V by the specification.
In addition, in the art, Foolad further teaches that from generation to generation of backcrossing of tomatoes, the genetic constitution changes, and the traits/physiological and morphological characteristics are instable in F2 and F3 generations (p14, right col, 1st to 2nd para).
Accordingly, the plants beyond F1 do not likely retain at least a full half set of chromosomes from the original plant. The claims read on higher filial generation seeds, plants and parts that have any number of genomic, phenotypic and morphological changes in comparison to the FIR-YA22-9246 or FIS-YA18-2246V. The different plants have can have different genomic, phenotypic and morphological characteristics, including different transgenes. In addition, the genus of seeds, plants and parts may loss the structural, physiological and morphological characteristics of seed and plant of the variety by generations of crossing.
Thus, the genus of tomato plants recited in claim 14 are further off from FIR-YA22-9246 or FIS-YA18-2246V in structure and function.
Regarding claims 16-18
According to the specification ([0024]), When used in conjunction with the word "comprising" or other open language in the claims, the words "a" and "an" denote "one or more," unless specifically noted otherwise.
Claim 16 recites a tomato plant produced by the method of claim 15 comprising introducing a (not “a single” like in claim 19) transgene.
Claim 17 recites a pepper plant comprising at least a first set of the chromosomes of the tomato lines further comprising a (not “a single” like in claim 19) transgene.
Accordingly, claims 16-18 are broadly drawn to a genus of pepper plants comprising at least a first set of the chromosomes of the claimed lines, and further comprising a genus of transgenes.
In addition and critically, the claims do not require the plants comprising the transgene, and otherwise comprising all of the physiological and morphological characteristics of FIR-YA22-9246 or FIS-YA18-2246V or SVTJ7542.
FIR-YA22-9246 or FIS-YA18-2246V or SVTJ7542 comprises one set of chromosomes from either parent, but none of them further comprises any transgene.
The specification does not describe any tomato plant further comprising a transgene, not to mention the common structure feature of the genus of plants.
In the art, Ladics et al (Genetic basis and detection of unintended effects in genetically modified crop plants. Transgenic Res 24:587–603, 2015) teach that insertion of transgenes can contribute to unintended effect in crop plants (p589, right col, last para; p590, left col, 1st para). Ladics et al teach that it is hard to predict whether pleiotropy (a single gene influences multiple traits) is likely to occur. For example, it is observed that lack of anthocyanin production in transgenic tomato comprising a heterologous gene regulating flavonol and anthocyanin production--the tomato plants had increases in some flavonols but no anthocyanin production because tomato lacks sufficient expression of another gene required for anthocyanin production. Variation in regulatory mechanisms is not only observed at the species level—different genotypes of the same species can have variation in regulatory mechanisms, which is one reason there is so much phenotypic and phenologic diversity in crop species. (p590, right col, last para; 591, left col, 1st para).
Given that the transgenes are not specific but generic, the claimed genus does not have any common structure and are heterologous in structure, physiological, and morphological characteristics.
Regarding the aspect of representative number of species, FIR-YA22-9246 and FIS-YA18-2246V and SVTJ7542 are the only 3 species described by the specification that comprise one set of chromosomes of FIR-YA22-9246 or FIS-YA18-2246V 34, and none of them further comprises any transgene.
The specification does not describe any species of F2 progeny nor any species further comprising any transgene(s).
Given that claim 10 does not have any requirement for genetic structure, the claimed plants having all the physiological and morphological characteristics of the plant of claim 1 is a heterologous genus of tomato plants, the number of species is extremely large, and are heterologous in structure.
The inbred and hybrid progenies of F2 generation and beyond of FDR-A818-0234 (claim 14) are an extremely large number, and are heterologous in structure.
Given the transgenes are generic not specific, the transgenic tomato plants (claims 16-18) are an extremely large number, and are heterologous in structure.
Hence, FIR-YA22-9246 or FIS-YA18-2246V or SVTJ7542 does not describe the common structure feature of the genera of tomato plants, and does not represent (not to mention sufficiently represent) the genus of the tomato plants as broadly claimed.
Therefore, the application has not met either of the two elements of the written description requirement as set forth in the court' s decision in Eli Lilly, and has not shown her/his possession of the claimed genera.
Remarks
According to the specification ([0028]) and claims 5 and 8, the parents of tomato hybrid SVTJ7542 are tomato line FIR-YA22-9246 and tomato line FIS-YA18-2246V.
By name searches, prior art does not disclose FIR-YA22-9246/NCMA 202406011, FIS-YA18-2246V/NCMA 202406012, or SVTJ7542. Prior art does not teach any pepper plant having all of the physiological and morphological characteristics, and genetic background, of FIR-YA22-9246, FIS-YA18-2246V, or SVTJ7542.
However, the breeding history and parental lines of instant FIR-YA22-9246 or FIS-YA18-2246V are missing in the instant specification. When such breeding history and parental lines become available (See the 112a rejection above), the examiner will perform further search.
Claims 25-27are not rejected under 35 USC 101, because FIR-YA22-9246 or FIS-YA18-2246V is deemed a new plant. Thus, determining the genotype of the new plant is not deemed as a routine method.
Conclusion
No claim is allowed.
Contact information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WAYNE ZHONG whose telephone number is (571)270-0311. The examiner can normally be reached 8:30am to 5:00pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bratislav Stankovic, can be reached on 571-270-0305. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Wayne Zhong/
Primary Examiner, Art Unit 1662