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 .
Claim Status
Claims 1-30 are pending.
Claims 1-30 are examined on the merits.
Specification
The disclosure is objected to because of the following informalities: in paragraph 0061 on page 15 of the specification there appears to be a typographical error; “parentline” should be separated in to two different words “parent line”. Similarly, in paragraph 0062 on page 15 “RijkZwaan” appears to be two separate words and should be separated as follows “Rijk Zwaan”.
Appropriate correction is required.
Claim Objections
Claims 1, 5, 12-13 and 28 recite the limitation “tomato (Solanum lycopersicum)” whereas other claims recite the limitation a “tomato” plant or “tomato” variety, etc. Therefore, claim 1, 5, 12-13 and 28 are objected to for using inconsistent claim limitations. To overcome this objection it is suggested that the limitation “(Solanum lycopersicum)” be removed from the claims.
Claim 10 recites the limitation “a” scion or rootstock, and should therefore use the definitive article when referring back to a previous claim. The limitation “a” should be replaced with --the--.
Claim Rejections - 35 USC § 112
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.
Claims 6, 7-9, 11 and 17 are rejected under 35 U.S.C. 112(b), second paragraph, as being issues of indefiniteness indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 6 is drawn to the plant part of claim 2. Claim 2 is directed to a tomato plant. Therefore, the metes and bounds of the claim are indefinite because it is not clear as to what plant part the claim refers.
Claims 7-8 are rejected for depending on an indefinite claim and failing to limit the scope of the claim to definite subject matter.
Claim 17 is drawn to tomato hybrid variety 72-MP0030 RZ further comprising a single locus conversion. Tomato hybrid variety 72-MP0030 RZ is a deposited variety with a fixed genome. Therefore, the metes and bounds of the claim are indefinite because it is not clear how the variety having a fixed genome may comprise a single locus conversion. Similarly, claims 18-19 are drawn to the hybrid tomato plant of variety 72-MP0030 RZ grown from seed of hybrid variety 72-MO0030 RZ and further comprising a transgene (Claim 18) which is introduced via transformation (Claim 19). It is not clear how the plants of the claimed variety, having fixed genetics can also further comprise transgenes and as such the metes and bounds of the claim are not clear.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 17-19 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claims 17-19 are all drawn to tomato plants of variety 72-MP0030 RZ, which has a fixed set of genetics which are characteristic of that variety. These claims all include additional limitations modify those genetics, for example claim 17 recites the tomato plant further comprising a single locus conversion, claim 18 recites the plant further comprising a transgene, and claim 19 recites the plant further comprising a transgene introduced by transformation.
The plants of variety 72-MP0030 RZ are drawn to a fixed set of genetics and therefore adding additional modifications to those plants means that they are no longer plants of that variety. Therefore, it is not possible for plants of that variety to comprise additional limitations and therefore the plants of claims 17-19 are interpreted to be drawn to plants of variety 72-MP0030 RZ and as such fail to further limit the claims upon which they depend.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Note on Deposit
The claims all require tomato hybrid variety 72-MP0030 RZ. Since the tissue of the claimed plant 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. Enablement rejections would have been made against all of the pending claims if not for the deposit of representative seeds of the claimed variety which were made and accepted by the NCIMB pursuant to the Budapest Treaty by on August 7, 2024.
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.
LACK OF BREEDING HISTORY
Claims 1-30 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 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 new Hybrid Tomato Variety 72-MP0030 RZ. 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 a phenotypic description provided in the trait table of figures 1-2. Additionally, in the specification in paragraphs 0060-0062 the applicant provides some information on the parents of the instant hybrid variety. Specifically, paragraph 0061 describes how the female parent line was produced using backcrossing to introduce a trait from one variety into another variety to produce the female parent. Similarly, paragraph 0062 describes how the male parent was produced using backcrossing to introduce a trait from one variety into another to produce the male parent.
However, none of the names of any of the instant variety, parent varieties or grandparent varieties appear to be known in the art. Further, it is not clear what traits were introgressed into the parent varieties using the backcrossing breeding methods, this information is meaningful and required in order to describe the genetics of the instantly claimed hybrid. Therefore while there is some breeding history provided it does not represent detailed breeding history which describes the genetics of the claimed variety. Because the specification lacks an adequate breeding history which describes the genetic characteristics of the instantly claimed cultivar 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/drawings to provide a complete 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 and grandparental lines utilized in the development of the instant cultivar and all other potential names for the claimed cultivar as well as the parent and grandparent cultivars. 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 00331 TOP in the Specification. This disclosure is insufficient because it does not address all the issues set forth above. Thus, the breeding history for the claimed cultivar as disclosed in the Specification is incomplete.
Written Description due to F2 Tissues
Claims 4, 6-7, 9 and 14-16 are rejected under 35 U.S.C. 112(a), 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, at the time the application was filed, had possession of the claimed invention.
Claim 4 is drawn to a plant part of the hybrid tomato plant including plant parts with haploid cells: microspores, ovules, egg cell, pollen as well as tissues from the next generation: embryos and seeds. Given that the instantly claimed plant is a plant of a hybrid variety, these haploid tissues and progeny tissues have distinct genetic and morphological characteristics from the parent variety, even reproducing plants from haploid material would not produce plants having all of the characteristics of the instantly claimed variety which is an F1 hybrid and therefore heterozygous at all loci. Further, F2 plants and tissues which include any plants or tissues produced through crosses between the claimed hybrid variety and any plant can have very distinct genetic and morphological characteristics from the claimed hybrid variety. While applicant has described the characteristics of the claimed hybrid variety, applicant has not described the genetic and morphological characteristics encompassed by all of the many possible F2 progeny plants or plant parts.
Claims 6-7 are directed to tissue or cell cultures of regenerable cells produced from the claimed hybrid tomato variety including those produced from F2 embryo tissues. As noted above with respect to the plant parts of claim 4, given that the claimed variety is a heterozygous F1 hybrid, F2 tissues, cells and cultures thereof can have very distinct genetic and morphological characteristics from the claimed hybrid variety. While applicant has described the characteristics of the claimed hybrid variety, applicant has not described the genetic and morphological characteristics encompassed by all of the many possible F2 progeny plants, tissues and cells.
Claim 9 is directed to a tomato plant which was regenerated from the tissue culture of claim 7 and exhibits a combination of traits or resistances including resistance against Mi, root rot, and several other pathogens as well as very small red fruit with medium firmness. Therefore, claim 9 is drawn to plants produced by propagating F2 embryo tissue to produce plants and as such is drawn to F2 plants. As noted above with respect to the plant parts of claim 4 and the tissue and cell cultures of claims 6-7, given that the claimed variety is a heterozygous F1 hybrid, F2 plants can have very distinct genetic and morphological characteristics from the claimed hybrid variety. While applicant has described the characteristics of the claimed hybrid variety, applicant has not described the genetic and morphological characteristics encompassed by all of the many possible F2 progeny plants. Additionally, while the claim is drawn to F2 tomato plants which exhibit a combination of traits selected from the list provided in the claims this is a limited pool of traits and those plants sharing these traits may retain significant morphological and genetic distinctions from the claimed variety.
Claim 14 is directed to a progeny plant produced by crossing the plant of the instant hybrid variety with itself or with another tomato plant, harvesting the resultant seed and growing that seed. These progeny plants are required to exhibit a combination of traits or resistances including resistance against Mi, root rot, and several other pathogens as well as very small red fruit with medium firmness. Given that these plants are produced by crossing a plant of the hybrid tomato variety with another plant and that they are not required to comprise all of the morphological and genetic characteristics of the claimed variety it is clear that these F2 progeny plants can have very distinct genetic and morphological characteristics from the claimed hybrid variety. While applicant has described the characteristics of the claimed hybrid variety, applicant has not described the genetic and morphological characteristics encompassed by all of the many possible F2 progeny plants. Additionally, while the claim is drawn to F2 tomato plants which exhibit a combination of traits selected from the list provided in the claims this is a limited pool of traits and those plants sharing these traits may retain significant morphological and genetic distinctions from the claimed variety. Claim 16 is drawn to the progeny plant of claim 14 wherein the progeny plant is modified in one or more characteristics. Therefore, not only does the claim depend on a claim lacking adequate description, the plant of claim 16 would appear to differ even more from the adequately described hybrid tomato variety and is therefore not adequately described.
Claim 15 is directed to the progeny plant of claim 13 which is a plant produced by crossing the plant of the instant hybrid variety with itself or with another tomato plant, harvesting the resultant seed and growing that seed, wherein the progeny plant exhibits al of the morphological and physiological characteristics of the claimed hybrid plant, wherein this progeny plant is modified in one or more characteristics. These progeny plants are F2 progeny plants and while the plants of claim 13 are required to have all of the characteristics of the claimed tomato variety and are therefore adequately described the plants of claim 15 comprise one or more modified characteristics. Therefore, these F2 progeny plants can have any number of modifications resulting in very distinct genetic and morphological characteristics from the claimed hybrid variety. While applicant has described the characteristics of the claimed hybrid variety, applicant has not described the genetic and morphological characteristics encompassed by all of the many possible F2 progeny plants.
Close Prior Art
The claims all require hybrid tomato variety 72-MP0030 RZ. The art appears to be silent on the instant variety as well as the parents of this variety.
The closest prior art is found in Solleveld (US Patent Application Publication US2016/0227724 A1 on August 11, 2016), which is drawn to hybrid tomato variety 72-190 RZ which shares many of the traits with the instant variety including, type, usage, growth habit, division of leaf blade, intensity of green leaf color, abscission layer, fruit size, green shoulder, fruit color, fruit firmness, sensitivity to silvering, Fusarium oxysporum race 0 and race 1 resistance, Verticilium sp. susceptibility, Fusarium oxysporum radices susceptibility, Tomato mosaic virus strain 0-2 resistance, Tomato spotted wilt virus susceptibility and Tomato yellow leaf curl virus susceptibility (Instant figure 1 and reference table 1). Importantly, the instant and reference varieties differ in parentage, breeding history, type of culture, height, fruit shape, ribbing at the peduncle end of fruit, number of locules in the fruit, time of maturity and Cladosporium fulvum resistance (Instant figure 1 and reference table 1).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN JAMES SULLIVAN whose telephone number is (571)272-0561. The examiner can normally be reached 7:30 to 5:00.
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 at (571)270-7058. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/BRIAN JAMES SULLIVAN/Examiner, Art Unit 1663
/Amjad Abraham/SPE, Art Unit 1663