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 .
Status
Claims 1-26 as filed on 16 April 2024 are examined herein.
Examiner’s Notes
Citations to Applicant’s specification are abbreviated herein “Spec.”
Paragraph 0027 of the specification states that the “parents of tomato hybrid SVTJ7215 are tomato line FIRXJ12-9050 and tomato line FIS-YA22-6554.”
The IDS Transmittal Letter, cited in the IDS, states that
tomato hybrid SVTJ7215, also known as 20-YA-FIS-7215, was developed from the cross of parent lines FIRXJ12-9050 and FIS-YA22-6554. Tomato hybrid SVTJ7215 comprises a Tomato Yellow Leaf Curl Virus resistance trait and a Root Knot Nematode resistance trait as described in U.S. Patent Nos. 7,615,689, and 8,785,720, a Fusarium oxysporum f. sp. lycopersici resistance trait as described in U.S. Patent No. 11,479,788, and a Stemphylium resistance trait as described in U.S. Patent No. 11,162,110. Tomato line FIRXJ12-9050 is a substantially homozygous, proprietary line developed from the initial cross of the substantially homozygous, proprietary lines 08GD0512 and 08EF0529, followed by pedigree selection until the F4 generation.
Examination of the patent application relies on the values presented in Table 1 for the claimed hybrid. Spec., pp. 10-15.
In Fehr (1987) (“Backcross Method” in Principles of Cultivar Development (Macmillan Pub. Co. (New York)) pp. 360-76), the backcross method is described as restoring 75% of the recurrent parent genome after the first backcross and restoring 87.5% of the recurrent parent genome after the second backcross (see Fig. 28-1, p. 362).
Copending Applications
Applicant should bring to the attention of the Examiner, or other Office officials involved with the examination of a particular application, information within their knowledge as to other copending United States applications, which are "material to patentability" of the application in question. MPEP 2001.06(b). See Dayco Products Inc. v. Total Containment Inc., 66 USPQ2d 1801 (CA FC 2003).
Information that is considered material to patentability includes for example, the following.
(a) The plants utilized in the breeding programs that arrived at the ancestral varieties crossed to produce the instant cultivar and their genetic relationship (e.g. grandparent lines).
(b) any progeny, siblings, half-siblings, or other closely genetically related plants that are either co-pending applications or previously published or publicly disclosed.
(c) if parental varieties that were crossed to arrive at the instantly claimed variety were developed via backcrossing this should be disclosed along with the grandparents, including which grandparent was the recurrent parent along with any publications or public disclosures of the recurrent parent and what events/loci/ transgenes/ traits were donated from the non-recurrent parent.
(d) if there is a locus converted or multiple loci converted between the deposited seeds and the seeds grown to cross to produce the hybrid seeds used for the hybrid plants grown for the trait table in the specification, then Applicant should specify which loci were converted and which traits differ when compared to plants grown from the deposited seeds,
(e) Any alternative designations, experimental names, tradenames, etc. for the instant plant, parent plants, and grandparent plants should be disclosed (e.g. synonyms).
Claim Objections
Claims 8, 19, 20, 21, and 25 are objected to because of the following informalities.
Claims 19, 20, and 21 have a hanging hyphen after SVTJ7215.
Claim 25 is objected to because it recites “the results” without an antecedent basis. To obviate potential difficulties under 35 USC 112(b), Applicant is requested to remove “the.”
Claim 8 is objected to because it doesn’t require growth under the same environmental conditions.
Appropriate correction is requested.
35 USC § 112(b)-Based Claim Rejections
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 1-26 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.
Claims 1-26 are rejected because they either recite the limitations FIRXJ12-9050; FIS-YA22-6554; or SVTJ7215, or their base claims do, in reference to tomato plants.
Until the deposit is perfected, the meaning of these limitations is uncertain and creates ambiguity in the claims and thus renders the claims indefinite. The terms are not well known and generally accepted in the art, and the use of this terminology does not carry art-recognized limitations defining the specific characteristics or essential characteristics that are associated with these denominations. In addition, the names appear to be arbitrary, and the specific characteristics associated therewith could be modified, as there is no written description of a tomato plant that encompasses all of its traits except by deposit. Thus the terms in question lack a general art-accepted meaning and Applicant does not explicitly define, and cannot do so without a deposit, the terms in the specification.
Furthermore, the meaning of these terms could arbitrarily change to designate something different during the lifetime of a patent.
For example, Applicant’s IDS transmittal letter states that “SVTJ7215 [is] also known as 20-YA-FIS-7215.”
Thus, one's ability to determine the metes and bounds of the claim would be impaired. See In re Hammack, 427 F.2d 1378, 1382; 166 USPQ 204, 208 (CCPA 1970).
Dependent claims are included in this rejection because none provide limitations obviating this rejection.
Applicant’s specification states that the deposits were accepted under the Budapest Treaty. However, still missing is an affidavit or declaration by the Applicant, or a statement by an attorney of record over her or his signature and registration number, stating that the seed will be irrevocably, and without restriction or condition, released to the public upon the issuance of a patent.
Other than this statement, the deposit is perfected.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of 35 U.S.C. 112(a):
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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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 Enablement Requirement of 35 USC 112(a) (Deposit)
Claims 1-26 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 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.
The invention requires plants asserted by Applicant to be the tomato hybrid SVTJ7215.
Since this 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. If the plant is not so obtainable or available, the requirements of 35 USC § 112 may be satisfied by a deposit of the seeds. A deposit of 625 seeds of each of the parents is considered sufficient to ensure public availability of the hybrid.
The specification does not disclose a repeatable process to obtain the plant and thus it is not apparent if the plant is readily available to the public with respect to this application. The specification does not teach such a process. Therefore Applicant must deposit seeds to comply with 35 USC 112(a).
The deposits were accepted under the Budapest Treaty. Spec., par. 0094.
As discussed above, however, a statement, affidavit or declaration by Applicant, or a statement by an attorney of record over his or her signature and registration number, or someone empowered to make such a statement, stating that the instant invention will be irrevocably and without restriction released to the public upon the issuance of a patent, is required to satisfy the deposit requirement made herein.
Dependent claims are included in this rejection because none provide limitations obviating this rejection.
Thus the deposit is not quite perfected.
Written Description Requirement regarding the Specification
Claims 1-26 is/are rejected under 35 U.S.C 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph / objected to, as failing to comply with the written description requirement in view of the following analysis of the specification.
The claims contain 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; or adequately described the claimed invention.
35 USC 112 (a) states that “The specification shall contain a written description of the invention.” In evaluating the written description requirement relative to the specification,, 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 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 hybrid, SVTJ7215.
Below is a consideration of what might constitute an adequate written description for a new variety. In evaluating this question of fact, consideration is given to the corresponding art in the public domain. Reviewing the art leads to a reasonable conclusion that generally the minimum requirements for an adequate description of a new plant line is a trait table of phenotypes and genetic information. The breeding history usually provides the genetic information. In reviewing the instant specification there is a phenotypic description in Table 1 (pp. 10-15.
There is only a minimal accompanying breeding history in the specification for the claimed SVTJ7215. The breeding history in the IDS Transmittal Letter is much more detailed and cites to two issued U.S. Patents. Further, this letter gives a synonym for the claimed hybrid.
Because the specification has only a minimal breeding history, it is not adequate to fully describe breeding history to illustrate the underlying genetics. Thus Applicant fails to fulfil the requirement of 35 USC 112(a) to provide a written description of the claimed invention in the specification.
A reasonable basis for challenging the adequacy of written description is informed by a review of the following:
The MPEP requires:
he 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))
This requirement is also part of the holding in the Enzo v. Gen-Probe decision.
Furthermore, the Guidelines state that "'[o]nce the patent issues, the description must be sufficient to aid in the resolution of questions of infringement.'" Guidelines at 1107-08 n. 6 (quoting Deposit of Biological Materials for Patent Purposes, Final Rule, 54 Fed. Reg. 34,864, 34880 (Aug. 22, 1989) (codified at 37 C.F.R. pt. 800)).
Enzo Biochem, Inc. v. Gen-Probe Inc., 285 F.3d 1013, 1022, 62 U.S.P.Q.2d 1289, 1295 (Fed. Cir. 2002).
Specifically, in claim 1, applicant claims a new tomato hybrid, SVTJ7215.
. Aside from the deposit, this tomato variety is defined by both its traits as set forth in Table 1 and by its genetics. A reasonable brief description of its genetics is its breeding history since exhaustive documentation of marker profiles is not found in the art.
In the instant application however, the specification only provides a minimal description of the breeding history and thus the underlying genetics.
Applicant discusses how to use genetic markers (para. 0019), but other than what is inherent in the deposited seeds, Applicant provides no information regarding the genetics of the deposited seeds.
See Vas-Gath Inc. v. Mahurkar, 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 [or her] 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.” Vas-Gath Inc. v. Mahurkar, 935 F.2d 1555, 1561, 19 U.S.P.Q.2d 1111, 1115 (Fed. Cir. 1991 ).
None of the traits recited in Table 1 are unique to the claimed variety. For example, many other tomato plants have the same size of fruit. The combination of the phenotypic traits provides a fingerprint that appears to be unique to the claimed tomato hybrid.
However a tomato plant is not produced by selecting individual traits, it is produced by breeding. Thus, in part to protect an unintentional infringer, the breeding history should be provided as a summary of the genetics behind the invention.
Further, availability of the breeding history will expedite a full and through examination of the pending claims
To illustrate this point further, the breeding history features prominently in a recent decision by the Office’s Appeals Board.
In the McGowen decision, after analyzing the breeding history (p. 7 (btm)-8), the Board found the claimed plants to be obvious (p. 10). Ex Parte McGowen (PTAB 2020) (decision in appl. ser. no. 14/996,093). The decision provided extensive discussion of the traits. (para 5-8 & 12 pp. 4-5) These differences were cited by the applicant when comparing the prior art and the new plant variety. But the trait tables insufficient to overcome the finding of obviousness. See, for example, McGowen, paras. 6 & 8 (pp. 4-5). The decision turned on the breeding history. (pp. 8 & 17). Because the breeding history was available, the phenotypic 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.
Thus the breeding history could prove to be extremely useful in the resolution of patent infringement by providing information necessary to determine whether differences in plants where genetic differences, differences caused by the environment, or differences within the normal expected variation within a variety.
For example, the art teaches that intracultivar heterogeneity exists in crop species. Haun et al. teaches that the assumption that elite cultivars are composed of homogenous genetic pools is false. For example, see Haun et al. (2011) Plant Physiol 155:645-55 (p. 645 left col.).
Segregation, recombination, DNA transposition, epigenetic processes, and spontaneous mutations are some of the reasons elite cultivar populations maintain some degree of plant-to-plant variation. E.g.,, Id., 645 (rt. Col. & 646 (lt. col.).
In addition to genetic variation, environmental variation may induce phenotypic variation within a cultivar. See for example, the teachings of Großkinsky et al. regarding “phenome.” Großkinsky et al. (2015) J Exp Bot 66(18):5429–40 (p. 5430 (lt. col. 1st full para. & rt. col. the full para.)).
In view of this variability, the breeding history is essential and is the least burdensome way to Applicant to provide genetic information needed by the Office and the public to adequately describe a newly developed plant.
An application that does not clearly describe the breeding history does not provide an adequate written description of the invention and impairs a factual determination of the uniqueness of the claimed line.
[T]he hallmark of written description is disclosure. Thus, "possession as shown in the disclosure" is a more complete formulation. Yet whatever the specific articulation, the test requires an objective inquiry into the four corners of the specification from the perspective of a person of ordinary skill in the art.”
Ariad Pharmaceuticals, Inc. V. Eli Lilly & Co., 598 F.3d 1336 (Fed. Cir. 2010) (en banc),
In particular, “possession as shown in the disclosure" and “the four corners of the specification.” Clearly the Ariad decision supports the rejection.
To overcome this rejection, Applicant should amend the specification/drawings to provide the breeding history used to develop the claimed variety. 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 aware of their duty to disclose information material to patentability (see e.g. C.F.R. § 1.56 and MPEP § 2001). 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 variety).
This information can be submitted in an IDS with a notation of the relevancy to the instant application. Or If necessary, this information may be submitted as described in MPEP § 724 (e.g., trade secret, proprietary, and Protective Order).
Additionally, claim 1 encompasses each parent individually since it only requires a set of chromosomes of either. The specification does not describe the breeding history of the parents.
Written Description Requirement regarding the Claims
Claims 1-26 are rejected under the following analysis. Claims 1-26 are drawn to tomato variety seeds, plants, plant parts, or plant cells related to hybrid SVTJ7215. The two parents are deposited.
Claim 1 only requires one set of chromosomes from each parent. Thus each parent can be crossed with any other tomato plant. Truly a vast pair of genera.
Claim 1 encompasses either parent individually. Also claims 3, 5, 15 and 17 only require one parent.
The claimed plants encompass plants having a set of chromosomes from either parent produced by any method using any starting materials. Applicant, however, only describes plants of tomato lines FIRXJ12-9050 and FIS-YA22-6554 by deposit and by Table 1 for the hybrid of those two lines and the parents.
Applicant does not adequately describe the genus of plants using any starting materials and any methods of breeding and genetic transformation that produces plants having all of the physiological and morphological characteristics of the plant of claim 1, the line SVQH2015. Further, the specification fails to provide adequate support for the breeding steps of how the line SVQH2015 was produced.
Because a vast number of other starting plants and methods exist which may be able to produce tomato plants having the characteristics of the plant claimed in claim 1, one of ordinary skill in the art would not have recognized that Applicant was in possession of the claimed genus.
Claim 8 reads on any combination of plants that can produce a plant with “all of the physiological and morphological characteristics of the plant of claim 1 but it does not reference the deposits.
Therefore it may be reasonably interpreted as having a different, broader, scope than claim 1.
The claimed plants encompass tomato plants sharing all of the physiological and morphological characteristics of the plant of claim 1 produced by any method using any starting materials. Applicant, however, in this specification only describes plants of the claimed tomato hybrid by deposits and by Table 1.
Claim 14 reads on a plant produced by the method of claim 13 which method adds a transgene to the plant of claim 1. Clearly such a transgene might be added by direct transformation, but it could also be added via backcrossing. Thus claim 14 includes early backcross generations which may bear little similarity to the claimed hybrid. (see below)
Similarly, claim 17 adds a locus conversion by any means – probably by backcrossing.. Paragraph 0035 discusses locus conversions, but notably ties the discussion back to the “the morphological and physiological characteristics of a variety.”
Applicant discusses backcrossing in paragraph 0032. This paragraph presents an issued in that it teaches that it requires five or more generations to return to the starting plant with the only the added trait.
Further, it acknowledges that the trait donor, relative to the claimed plant, may very well have numerous differences from the claimed plant – and probably does.
The claims, however, do not require “five or more” generations. Nor do they require direct transformation.
Fehr also teaches that genes conferring traits that are completely different from those of the target line could be linked to a locus conversion being introduced by backcrossing (Fehr (op cit.), p. 371). As a result, the genus of plants derived from the deposited parents by introducing a locus conversion or transgene via backcrossing could have morphological and physiological characteristics that differ dramatically from those of line claimed tomato hybrid.
The same analysis can be applied to claim 14.
Further, the claims use open language – “comprising” and thus there can be other steps. Also further, Applicant uses an expansive definition of “a” as “one or more” in paragraph 0023.
Therefore, for example, claims 17 and 14 read on the deposited seed/plants with a very large number of added traits, transgenes or other variations.
Therefore the scope of the claimed genus is certainly very large.
These claims are "reach through" claims in which the Applicant has potentially described a starting material, the deposited seeds, but also encompasses further changes, however, they have not described the resulting product, and the genus of products that can be produced by the recited starting materials is so large that one of skill in the art is not able to envision the members of the genus. See e.g. Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 920-23, 69 USPQ2d 1886, 1890-93 (Fed. Cir. 2004).
See also Vas-Gath Inc. v. Mahurkar, 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 [or her] 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.” Vas-Gath Inc. v. Mahurkar, 935 F.2d 1555, 1561, 19 U.S.P.Q.2d 1111, 1115 (Fed. Cir. 1991 ). Therefore, in the instant application, the disclosure of a single tomato plant by deposit (to be perfected), does not provide adequate written description for the claimed genus of plants. The specification fails to describe the fully array of plants comprising the genus of transgenes, heritable traits and/or locus conversions encompassed by the claims. The specification fails to provide an adequate written description to support the breadth of the claims, Applicant has not demonstrated possession to one of skill in the art of the instant invention as broadly as claimed at the time of filing.
In the instant application, a practitioner would not be able to envision the claimed genera and thus be able determine if any particular tomato plant is infringing the instant claims., Therefore, the public has not been put on notice with a sufficient description of the claimed invention.
Dependent claims are included in this rejection because none provide further limitations obviating this rejection.
Allowable Subject Matter
Close art relative to the claimed variety is below.
(1) The hybrid tomato plant named hm 12595, U.S. Patent Publication No. 2022/0400642 A1, Pais de Arruda (Table 1, p. 23 et seq.).
Both have anthocyanin coloration of hypocotyl; indeterminate growth habit; and bipinnate blades.
However, the instant fruit size is medium versus large; weak versus medium leaf blistering; and more anthocyanin in stem in the instant plant.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RUSSELL T BOGGS whose telephone number is (571)272-2805. The examiner can normally be reached Monday - Friday, 0800 to 1830 Mtn.
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/RUSSELL T BOGGS/
Examiner, Art Unit 1663
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