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 .
Status
Claims 1-22 as filed on 26 March 2024 are examined herein.
Examiner’s Notes & Claim Interoperation
Citations to Applicant’s specification are abbreviated herein “Spec.”
Applicant’s statement on page 29 of the specification satisfies the requirements of 37 C.F.R. § § 1.801-1.809. Therefore the deposit is considered perfected.
The background regarding the state of the art, a line/variety is distinguished from other plants of the same species by DUS traits and/or by genetic fingerprint which is determined largely by the ancestors. See, for example, Smykal et al. (2008) J Appl Genet 49(2), 155–66 (abstract).
Examination of the patent application relies on the values presented in Table 1 for the claimed line. Spec., pp. 9-12.
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 would be 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 line 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).
Some of this material is part of the file history in the IDS transmittal letter.
35 USC § 112(a) based Claim Rejections
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.
Claims 4, 9, 11, 12, 13, 14, and 15 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 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.
Claim 11 is rejected because it is drawn to a plant produced by a method where the only step is introducing a trait via a transgene into the plant of claim 1.
One way to introduce such a trait is backcrossing where the transgene is in another pea plant used as a donor..
Applicant discusses backcrossing in paragraph 0036. This paragraph presents a problem in that it teaches that it requires five or more generations to return to the starting plant with the only the added trait. This is consistent with the teachings of Fehr above.
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.
Claim 11, however, does not require “five or more” generations. Nor does it 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, p. 371). As a result, the genus of plants derived from pea line SVQF2070 by introducing a locus conversion or transgene via backcrossing could have morphological and physiological characteristics that differ dramatically from those of line pea cultivar SVQF2070.
Further, claim 10 uses open language – “comprising.”
Therefore the claims read on the deposited seed/plants with a very large number of added traits or other variations.
Therefore the scope of the claimed genus is certainly also very large.
Thus 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 claimed pea line by deposit 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 plants with added 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 may not be able to determine if any particular pea plant is infringing the instant claims, and therefore, the public has not been put on notice with a sufficient description of the claimed invention.
The rejected dependent claims do not impact the scope of the claims and are therefore included in this rejection.
Claims 12 and 13 are included in this rejection under a similar analysis.
Claims 14 and 15 are included in this rejection under a similar analysis with the addition of Applicant’s discussion of a “locus conversion” in paragraph 0040. The discussion in paragraph includes the concept that all is required is “essentially all of the desired morphological and physiological characteristics of a variety are recovered or conserved.” (emphasis added).
Claim 4 is included under the following analysis. Claim 4 encompasses a a pea plant having all of the physiological and morphological characteristics of the plant of claim 1 however the claim does not reference the deposit. Therefore it is reasonably interpreted as having a different, broader, scope than claim 1.
The claimed plants encompass pea 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, only describes plants of pea cultivar SVQF2070 by deposit and by Table 1 (Spec., 9-12).
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 SVQF2070. Further, the specification fails to provide any support of how the line SVQF2070 was produced. No breeding history is described at all.
Because a vast number of other starting plants and methods exist which may be able to produce pea plants having the characteristics of the plant of claimed 1, one of ordinary skill in the art would not have recognized that Applicant was in possession of the claimed genus.
Claim 9 is included in this rejection because it vaguely refers to ‘a’ plant produced by the method of claim 8 – any plant produced during the process. Claim 9 makes no reference to the added trait of the other “morphological and physiological characteristics.” Additionally, claim 8 stops at the fourth backcross and even Applicant’s specification requires five. Spec., para. 0036.
The Enablement Requirement of 35 USC 112(a) (Deposit)
Claim 4 is 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 novel, the line SVQF2070.
Claim 4 encompasses a pea plant having all of the physiological and morphological characteristics of the plant of claim 1 however the claim does not reference the deposit. Therefore it is reasonably interpreted as having a different, broader, scope than claim 1.
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. In fact the specification is completely silent as to how to obtain the pea line.
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 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). If a deposit is made, the deposit must be accepted under the terms of the Budapest Treaty or the results or a viability test must be provided.
Further, a release statement must be made. Applicant must affirm that all restrictions upon availability to the public will be irrevocably removed upon granting of the patent in accordance with 37 CFR § 1.808(a)(2). This statement must appear above the signature of the Applicant or the Applicant's representative.
EXAMINER’S NOTE
As noted above, regarding claims 1-3 and 5-22, the deposit is perfected.
However amending claim 4 to reference the deposit might create double-patenting issues with respect to claim 1.
Written Description / Specification
Claims 1-22 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 invention is a new pea line, the SVQF2070 line.
Below is a consideration of what might constitute an adequate written description for a variety/line. In reviewing this question of fact, an evaluation is conducted in view of the corresponding art 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 genetic information. The breeding history usually provides the genetic information. In reviewing applicant’s specification there is a phenotypic description in Table 1 (pp. 9-12).
However, there is no accompanying breeding history in the specification for the claimed line other than the deposited seeds together with its designation.
,. Because the specification lacks a breeding history and that breeding history is part of the minimum description of a plant line 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:
In another section of the MPEP, 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 (2023) 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 (2017) Explanatory Notes on Essentially Derived Varieties Under the 1991 Act of the UPOV Convention (6 April 2017), see UPOV EDV Explanatory Paragraphs 14, 20 30 (V)) (pp. 7-11).
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) (W) and Ex Parte McGowen Board Decision in Application 14/996,093, decided June 15, 2020 (X)). In both of these cases, there were many differences cited by the Applicant when comparing the prior art and the new plant 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, a trait table is not necessarily sufficient to differentiate varieties by itself. It has been long established 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.). In addition to genetic variation, 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 that requiring a breeding history to make a factual determination of the genetics to a to-be-patented line.
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 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 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 § 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 the resolution of patent examination as well as 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 line.
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 any breeding history, the public will not be able to resolve questions of potential 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 and impairs a factual determination of the uniqueness of the claimed line.
To overcome this rejection, Applicant should amend the specification/drawing to provide the breeding history used to develop the instant line. 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.
35 USC 112(a) states “[t]he specification shall contain a written description of the invention.”
The 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.
This is especially critical in the case of claim 4 in light of the discussion of that claim elsewhere herein.
Conclusion
Claims 1-3, 5-8, 10, and 16-22 are allowed.
Allowable Subject Matter
The claimed SVQF2070.pes line appears to be free of the prior art of record. Black hilum is a fairly rare phenotype.
As a representative comparison, Varity SVQF2070 by Hendricks in U.S. Patent Publication 2025/0301991 A1.
Both have black hilum and ‘cream & green’ primary color
green cotyledon
seeds flattened / cylindrical
similar pods
However,
their cotyledon wrinkling is different
and different node numbers
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