DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after 16 March 2013, is being examined under the first-inventor-to-file provisions of the AIA .
Election/Restrictions
A restriction requirement was posted on 21 May 2026.
Applicant's election without traverse of tomato E16R43164 in the reply filed on 20 July 2026 is acknowledged. The requirement is deemed proper and is therefore made FINAL. Applicant also cancelled claims 14-16 without prejudice.
Claims 1-13 and 17-23 as amended on with the response are examined herein.
Since there is only one inventor, the inventorship cannot change.
The Office notes with thanks that the title was amended.
Examiner’s Notes
Citations to Applicant’s specification are abbreviated herein “Spec.”
Examination of the patent application relies on the values presented in Table 3 for E16R43164. Spec., p. 17-19.
The background regarding the state of the art, a variety is distinguished from other plants of the same species by DUS traits and/or by genetic fingerprint.
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).
Also, Applicant discusses “backcross conversion” in paragraph 0088. Applicant discusses single locus conversion in paragraph 0091 but allows for multiple changes at a single locus.
Claim Interpretation
The limitation “X2” in, for example, claim 1, is reasonably interpreted as being a place-holder for the accession number.
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).
The Office acknowledges application serial no. 18/987,408.
Specification
The disclosure is objected to because of the following informalities.
The disclosure is objected to because the deposit information in paragraphs 0009 and 0097 does not provide the deposit number; instead it recites “X2” as a placeholder for accession number. Furthermore, no date is provided for the deposit.
The placeholder “X2” appears in several other places in the specification. For example, paragraphs: 0014-0019. All should be replaced with the accession number.
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 1-13 and 17-23 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, 12, 17, 18, 21 and 23 are rejected because they recite the limitation “E16R43164” for a tomato plant. The meaning of the limitation “E16R43164” is uncertain and creates ambiguity in the claims and thus renders the claims indefinite.
The term for a seed or a plant “E16R43164" is not known in the art other than this application, and the use of this designation by itself does not carry art-recognized limitations defining the specific characteristics or essential characteristics that are associated with this denomination. In addition, the name appears 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 term in question lacks a general art-accepted meaning and Applicant does not and cannot explicitly define the term in the specification.
Furthermore, the meaning of this term could arbitrarily change to designate something different during the lifetime of a patent. 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).
As part of the above rejection under 35 USC 112(b), several claims are additionally ejected because they include the placeholder “X2“ instead of the deposit number; which again has no meaning in the art.
Perfecting the deposit and filling updating the claims with that information will obviate these aspects of the rejection.
Dependent claims are included in the rejection because they fail to provide further limitations obviating the rejections.
Claim Rejections - 35 USC § 112(a)
The following is a quotation 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 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.
Enablement (Deposit)
Claims 1-13 and 17-23 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 features novel plants. Since the 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 claimed embodiments is considered sufficient to ensure public availability.
The specification does not disclose a repeatable process to obtain the plant and thus it does not appear that the plant is readily available to the public.
Applicant has not deposited seeds relative to his application. Spec., para. 009.
The seeds must be accepted under the terms of the Budapest Treaty or their viability must be tested and results provided.
Also required is an affidavit or declaration by the Applicant, or a statement by an attorney of record over his or her 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.
Although paragraph 0009 recites an accession number, it appears to be a placeholder for the actual deposit number.
Written Description
Claims 6, 7, 8, and 12 are rejected under 35 U.S.C. 112(a), as failing to comply with the written description requirement. 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 inventors, at the time the application was filed, had possession of the claimed invention.
Claim 6, for example, is drawn to plants having "essentially all" the same characteristics as the deposited tomato variety.
Claim 12 reads on a plant regenerated from tissue culture
having "essentially all" the same characteristics as the deposited tomato variety.
Neither the specification nor the claims indicate what characteristics or how many must be retained to be considered "essentially all."
Also, Applicant discusses “backcross conversion” in paragraph 0088. Applicant discusses single locus conversion in paragraph 0091 but allows for multiple changes at a single locus.
Thus even a single locus conversion has the potential to introduce a number of changes in the morphology and phenotype of the plant that might remain even upon backcrossing with the parental material.
Accordingly, since the claims do not indicate that the plants would retain all the same phenotypic and morphological features except the locus conversion, the claims read on a large genus plants with an uncertain number of changes. Given this, an ordinary artisan would not be able to ascertain full possession of the claimed invention. Accordingly the rejected claims lack adequate written description as currently written.
Additionally, claim 6 reads on any tomato plant of lineage as long as it resembles the plant of claim 2. That is a vast genus and an artisan may be unable to discern the boundaries of this genus.
Dependent claims are included in the rejection because they fail to provide further limitations obviating the rejections.
Written Description / Specification
Claims 1-13 and 17-23 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 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 claimed invention is a potentially novel tomato plant, E16R43164.
.
However, there is no accompanying breeding history in the specification.
Below is a consideration of what might constitute an adequate written description for a potentially novel plant.
In reviewing this question of fact, an evaluation is conducted in view of the corresponding art and evaluations in the public domain. This review concludes that generally the minimum requirements for an adequate description of a new plant line is a trait table of phenotypes and the genetic information that characterizes. A breeding history usually teaches the genetic information.
In reviewing applicant’s specification there is a phenotypic description in Table 3. Spec. pp. 17-19.
There is, however, no accompanying breeding history in the specification for the claimed plant. Thus there is no description of the underlying genetics.
,. Because the specification lacks a breeding history and that breeding history is part of the minimum description of a plant line 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:
In another section of the MPEP dealing with 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 also part of the requirements of applications for Plant Variety Protection (PVP). 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 (2023) https://www.ams.usda.gov/services/pv po/application-help/apply (downloaded 05/01/2023).
Further, the USPTO has considered breeding history information when determining the patentability of a new plant line. (See Ex Parte C (USPQ 2d 1492 (1992) and the Ex Parte McGowen Board Decision in application serial no. 14/996,093, decided 15 June 2020). In both of these cases, there were many differences cited by the Applicant when comparing the prior art and the new plant line. 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, the trait tables were not sufficient to differentiate varieties.
Further, the art is aware that intracultivar heterogeneity exists in crop species. Haun et al. (2011) teaches that the common assumption that elite cultivars are composed of relatively homogenous genetic pools is false. Haun et al. (2011) Plant Physiol 155:645-55, 645, left col. 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 (Id., 645, right col. and p. 646, left col.).
Additionally, environmental variation may lead to phenotypic variation within a cultivar. Großkinsky et al.(2015) J Exp Bot 66(11):5429-40, 5430, left col., 1st full para., and right col., 2nd full para.). 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 provides a reasonable basis for requiring a breeding history to make a factual determination of the genetics to a to-be-patented plant.
Thus, the Office meets its initial burden of presenting by a preponderance of evidence why a person of ordinary skill in the art would not recognize in Applicant’s disclosure a full description of the invention defined by the claims. See MPEP 2163.04.
The citations above are not for their legal authority –the 35 USC 112(a) statute provides the legal authority. The citations are presented as persuasive evidence to support an analysis of the facts in this application that a breeding history is necessary to the adequate description of a plant.
Again, 35 USC 112(a) states “[t]he specification shall contain a written description of the invention.”
Further,
[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.
Thus the specification / disclosure is insufficient because it does not address all the issues set forth above. The names of any ancestral lines and the direct parents of claimed line are unknown in the art. It is unknown if the parents are known in the prior art under different names. Thus, the breeding history for the claimed cultivar as disclosed in the Specification is incomplete.
A complete written description additionally helps drive examination and help with any subsequent infringement analysis.
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 § 2411.05 states
sets forth the requirements for the content of the specification with respect to a deposited biological material. Specifically, the specification shall contain the accession number for the deposit, the date of the deposit, the name and address of the depository, and a description of the deposited biological material sufficient to specifically identify it and to permit examination. The description also 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.
Thus the breeding history aids in examining the pending claims as well as potential infringement analysis if a patent issues 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 plant variety.
Because the instant specification and prosecution file lacks any breeding history, the public is severely hampered in its ability address potential infringement issues if the patent issues. 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 and impairs a factual determination of the uniqueness of the claimed plant.
To overcome this rejection, Applicant should amend the specification/drawings to provide the breeding history used to develop the instant claimed plant. 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.
Conclusion
No claim is allowed.
Allowable Subject Matter
The claimed E16R43164 hybrid tomato appears to be free of the prior art of record. It is somewhat similar in phenotype to Ramon & Hoogstraten’s hybrid PS01059664 in U.S. Patent Publication 2011/0179515 A1
Both have sprawling (decumbent) growth habits. Also rugose surface of major leaflets; & adapted for field and greenhouse.
They differ in fruit shape: cylindrical / slightly flattened
(instant first) yellow / red/pink.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amjad Abraham can be reached at 571-270-0708. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RUSSELL T BOGGS/ Examiner, Art Unit 1663
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