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
Claims 1-24 are pending and examined on the merits.
Specification
The specification is objected to because the NCMA accession number is missing in numerous places, e.g. paragraph [0017]; further there is no date of deposit included in the deposit information in paragraph [0177].
Appropriate correction is required.
Claim Objections
Claims 5, 13, 16-19, 21 and 22 are objected to because of the following informalities:
For consistency and clarity, claims 4, 13 and 15 part (d and e) should be amended as follows “…characteristics of tomato variety NUN 00348 TOP when grown under the same environmental conditions…” (See language of claim 3 and 6 for reference)
Claims 12-14 and 18-19 recite “said method comprises” in the first two lines. These recitations should be amended to recite “said method comprising” in order to improve claim syntax and match the recitations of at least claim 20.
The last three words of Claim 19 recite the phrase “…or part thereof”. In order to improve claim syntax and use consistent language throughout the claim set, the office suggests amending Claim 19 to recite “…or a part thereof”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The recitation of “NCIMB ____” in claims 1, 5-6, 8, and 13-15 is indefinite because the claim does not clearly set forth the metes and bounds of the patent protection desired. Without the accession number for the plant tissue deposited to the NCMA the scope of the claim is not clear because the representative deposit of the claimed variety is not clear. The claim is vague and indefinite due to the missing accession number because of the requirement that the inventor claims what is viewed as the invention. Therefore, claims 1, 6-7, 9, and 16-18 are rejected as indefinite for failing to clearly set forth the metes and bounds of the claims.
Claims 2-4, 7, 9-12, and 16-21 are rejected for depending from rejected claims and failing to recite additional limitations that would render the claims definite.
Deposit of Biological Material
This application requires public availability of specific biological material to make and use the claimed invention. A rejection under the appropriate sections of 35 USC 112 would have been made but for (1) evidence that the material is both known and readily available; (2) applicant’s statement is paragraphs 177-178 of the specification filed 23 December 2024 indicating that an acceptable deposit of the specific biological material in compliance with the requirements under 37 CFR 1.801-1.809 will be made with a recognized IDA, at or before the payment of the issue fee, in the event that the application should be determined to be allowable; or (3) an acceptable deposit of the specific biological material in compliance with the requirements under 37 CFR 1.801-1.809 has already been made. Because viability testing of all deposits is required before they can be considered to meet the requirements of 37 CFR 1.801-1.809, applicants are advised to perfect the deposit as early as is possible, and before the payment of the issue fee. Failure to perfect a deposit by the date of payment of the issue fee may result in abandonment of the application for failure to prosecute.
Enablement
Claims 1, 3, and 15-16 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 enablement requirement. The claims contain 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.
The instant specification makes clear that NUN 00348 TOP is an F1 hybrid variety. Without access to the inbred parent lines, it is not possible to make a hybrid seed of NUN 00348 TOP, nor is it possible to make locus conversion lines of NUN 00348 TOP. This is the case, because making a locus conversion requires backcrossing to an inbred parent to introgress a locus of interest. Backcrossing to an F1 hybrid as is claimed will never lead to traits becoming fixed such that a plant could “otherwise comprise all the physiological and morphological characteristics of NUN 00348 TOP.” A screen capture of MPEP section 2401.01 is provided below which states that deposited material must be capable of self-replication. Accordingly, claims 1,3, 6, and 17 are rejected under 35 U.S.C. 112(a) for lacking enablement.
Written Description
Claims 1-21 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.
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 a 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 variety (NUN 00348 TOP). So, the examiner will evaluate what is an adequate written description for a new tomato variety. In reviewing this question of fact, the examiner analyzed how plant varieties are evaluated in the public domain. The review concluded that generally the minimum requirements for an adequate description of a new plant variety include a trait table and genetic information (via a breeding history). In reviewing applicant’s specification there is only a phenotypic description as is seen in Tables 1-2. However, there is no accompanying detailed breeding history in the specification which sets out the parental genetics and specific breeding history of the claimed variety. Because the specification lacks an adequate 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).
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).
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). 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) 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, 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.
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 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 cultivar and all other potential names for the claimed cultivar. If Applicant’s breeding history uses proprietary cultivar names, 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, 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 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).
35 USC 112(a) clearly states “The specification (emphasis added) shall contain a written description of the invention”.
In the instant application, Applicant included some breeding history for tomato variety NUN 00348 TOP in the Specification. This disclosure is insufficient because it does not address all the issues set forth above (lack of adequate disclosure regarding the parental genetics and specific breeding history of the instant tomato variety). Thus, the breeding history for the claimed cultivar as disclosed in the Specification is incomplete. Moreover, the claims indicate Applicant intends to deposit seeds representative of the claimed cultivar. Paragraph [0124] states that “The morphological and/or physiological characteristics may vary somewhat with variation in the environment (such as temperature, light intensity, day length, humidity, soil, fertilizer use)”.
Additionally, at least Claims 2, 5, 7, 10, 12 and 15 are drawn to plant parts and tissues which include fruits and the seeds that they contain. Given that the instant tomato variety is a hybrid tomato variety seeds produced from the instantly claimed variety would be F2 tissue and therefore it is unpredictable what genetic material its F1 progenies would inherit. Thus, the claims are not directed to solely the deposited seeds or plants grown therefrom. The claims are directed to a genus of plants and seeds that are genotypically and phenotypically different from the deposit, and have different traits from those disclosed in the specification. Given these differences, the complete breeding history for producing the claimed variety, including all names for the parents and for the claimed cultivar, are material for patentability. A specification devoid of a complete breeding history hampers the public’s ability to fully resolve questions of infringement.
Additionally, claim 21 is a product-by-process claim referring back to Claim 20. Claim 20 recites targeted gene editing of a plant/part of NUN 00348 TOP so that a target gene is mutated. The targeted gene is one involved in male sterility, herbicide tolerance, insect resistance, pest resistance, disease resistance, environment stress tolerance, carbohydrate metabolism, or protein metabolism.
It should be noted that claim 21 does not specify that the claimed tomato plant is modified to comprise the mutated target gene and “otherwise has all the physiological and morphological characteristics of tomato variety NUN 00348 TOP when grown under the same environmental conditions”. These deficiencies are material because, without them, it is not clear what physiological and morphological characteristics the claimed plant would have. In particular, the specification does not provide evidence that Applicant would know what physiological and morphological characteristics one such mutant tomato plant would have. The prior art does not remedy the deficiencies of this specification.
Without adequate description from Applicant, a skilled artisan would not reasonably recognize Applicant has having possession of the full metes and bounds of the plants encompassed by claim 21 (which, again, need not be modified and need not comprise the mutant target gene). To overcome this aspect of the written description rejection, claim 21 should be amended to recite, for example, “A modified tomato plant produced by the method of claim 20, comprising the mutated target gene and otherwise has all the physiological and morphological characteristics of tomato variety NUN 00348 TOP when grown under the same environmental conditions.”
Closest Prior Art
The claims all require tomato variety NUN 00348 TOP. While the specific parents and genetic characteristics of the instant tomato variety are unknown, the instant variety appears to be free of the prior art. The closest prior art in regard to the instant tomato variety can be found in Silvertand et al. (CA 3142210) which teaches tomato variety NUN 09325 TOF. The instant and reference varieties share many characteristics including anther color, flower color, leaf color, corolla color, fruit color. However, the two varieties differ in at least shape in longitudinal section and shape of blossom end.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LI ZHENG whose telephone number is (571)272-8031. The examiner can normally be reached Monday-Friday (9-5).
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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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/LI ZHENG/Primary Examiner, Art Unit 1662
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