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 .
Information Disclosure Statement
The Information Disclosure Statements filed on 8/9/2024 have been entered and considered. Initialed copies of the form PTO-1449 are enclosed with this action.
Status of claims
Claims 1-24 are pending and examined.
Priority
Instant application 18679136, filed 05/30/2024, claims Priority from Provisional Application 63505841, filed 06/02/2023, which is recognized.
Interpretation of claim 1
In the claim, the “a plant” is interpreted as a plant that grows from the seed of the same claim that a representative sample of seed is deposited under the particular Accession Number NCIMB 44140.
Claim Rejections - 35 USC § 112
Lacking written description
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.
Claims 1-24 are rejected under 35 U.S.C. 112(a), as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The rejection is made because the specification fails to disclose the breeding history and parent lines of the instant cucumber variety NUN 53040 CUP.
A full examination cannot be conducted because the applicant failed to provide the parent lines and breeding history for the instantly claimed plant line. The applicant is claiming a seed and a plant of NUN 53040 CUP, possibly a new plant. A plant line is defined and described by both its genetics (breeding history particularly the parent line(s)) and its traits.
In the instant application, the applicant has only provided the “Characteristics of Cucumber Variety NUN 53040 CUP” ([0188]-[0191], Tables 1-2).
However, according to the specification ([0184]), “Development of Cucumber Variety NUN 53040 CUP The hybrid variety NUN 53040 CUP was developed from a male and female
proprietary inbred line of Nunhems. The female and male parents were crossed to produce
hybrid (Fl) seeds of cucumber variety NUN 53040 CUP. The seeds of cucumber variety NUN
53040 CUP can be grown to produce hybrid plants and parts thereof (e.g., cucumber fruit).
The hybrid variety NUN 53040 CUP can be propagated by seeds or vegetatively”. Thus, instant specification does not describe the breeding history, particularly the parent line(s), of the claimed NUN 53040 CUP. In another word, the instant application is silent or incomplete as to the breeding history used to produce the claimed plant line.
As a result, instant specification fails to satisfy the written description requirement of 35 U.S. Code § 112(a) because it does not provide a description sufficient to conduct an examination, including search of the prior art, nor does it provide enough description to be sufficient to aid in the resolution of questions of infringement.
10. MPEP 2163 (I) states that “…. a deposit is not a substitute for a written description of the claimed invention. 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.").” and states that “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 criticality of a breeding history in assessing the intellectual property rights of a plant is well recognized in the field of plant breeding. With regard to Plant Patents, MPEP 1605 states that a complete detailed description of a plant includes “the origin or parentage”. Other bodies that grant intellectual property protection for plant varieties require breeding information to evaluate whether protection should be granted to new varieties. A breeding history, including information about parentage and breeding methodology, is part of the requirements of Plant Line Protection (PVP) applications. That information is used to “determine if development is sufficient to consider the line new” (See “Applying for a Plant Line Certificate of Protection” by the USDA reference to Exhibit A). Additionally, 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 (See UPOV EDV Explanatory Notes 14 and 30). While the USPTO, USDA, and UPOV have different laws governing intellectual property rights, all recognize that a breeding history is an essential part of adequate description of the plant sought to be protected.
The breeding history is also necessary to aid 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 accepted variation within a line. Historically, 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 Ex Parte McGowen- Board Decision in Application 14/996,093). 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. Moreover, a specification devoid of a 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 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.
Furthermore, a breeding history particularly parent lines is essential to search siblings of instant plant to determine if there is/are any double patenting(s).
As seen above in Ex Parte C and Ex Parte McGowan, a trait table (for example, Table 2 in [0060]) is insufficient to differentiate varieties by itself. It has been long established that intracultivar heterogeneity exists in crop species.
In the art, the physiological and morphological characteristics of plants depend on the genetical structure.
For example, Haun et al (The Composition and Origins of Genomic Variation among Individuals of the Soybean Reference Cultivar Williams. Plant Physiology. P645-655, 2011) teach that the assumption that elite cultivars are composed of relatively homogenous genetic pools is false (P645, 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. (p645, right column; P646, left column).
For another example, Grobkinsky et al (Plant phenomics and the need for physiological phenotyping across scales to narrow the genotype-to-phenotype knowledge gap. Journal of Experimental Botany, Vol. 66, No. 18 pp. 5429–5440, 2015) teach that environmental variation may lead to phenotypic variation within a cultivar (p5430, last 2 paras; p5431, whole page). However, the genetic structure (genotype) is the major determinant of the phenotype of a plant (p5431, fig 2).
For another example, Tibbs-Cortes et al (Comprehensive identification of genomic and environmental determinants of phenotypic plasticity in maize. Genome Research. p1253-1263, 2024) teach that corn/maize phenotypes are determined by the complex interplay of genetics and environmental variables (p1253, Abstract). Tibbs-Cortes et al discovered that flowering time is controlled by some genes or candidate genes. Some genes are significantly influential to maize flowering time than the others (p1256, left col, last para; whole right col; Figure 3). Tibbs-Cortes et al teach that such genotypes are from the parents of the corns (p1259, right col, 3rd para; p1261, left col, 2nd para).
Particularly in cucumber plant, for example, Ene et al (Studies of phenotypic and genotypic variation in sixteen cucumber genotypes. Chilean J. Agri. Res. P307-313, 2016) teach that genetic variability in crop breeding lines is important for successful plant breeding. Heritability provides evidence for genetic control for the expression of a given trait and phenotypic reliability to predict its breeding value. It also estimates genetic advance that a breeder can expect from selection and which breeding method to adopt. The success of any breeding program greatly depends on the genetic diversity available in the population (p307, right col, 3rd to 4th para). Ene et al conducted scientific experiments and reached such conclusion (Materials and Methods in p308-309; Results and Discussion in p309-312). Ene et al teach that heritability (genotype) estimates give an insight into the extent of genetic control to express a particular trait and phenotypic reliability in predicting its breeding value (p3010, right col, last para).
Therefore, a breeding history especially parent lines are essential and the least burdensome way to provide genetic information needed at adequate describe a newly developed plant, including in cucumber plants.
To overcome this rejection, the applicant must amend the specification/drawing to provide the breeding history used to develop the instant line or cultivar. When identifying the breeding history, the applicant should identify any and all other potential names for all parental lines utilized in the development of the instant line. For example, if the applicant’s breeding history uses proprietary line names, the applicant should notate in the specification all other names of the proprietary lines, especially publicly disclosed or patented line information. If the breeding history encompasses a locus conversion or a backcrossing process, the 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, the applicant should provide the breeding history of the parent line as well (i.e. grandparents).
The applicant is also reminded that she or he has a duty to disclose information material to patentability. The 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 line). 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).
Claim 24 is additionally rejected under 35 U.S.C. 112(a), as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claim is broadly drawn to a genus of cucumber plants produced by the method of claim 23, which includes mutating genes in NUN 53040 CUP.
According to the specification ([0143]), the plant of cucumber variety NUN 53040 CUP may also be mutated (by e.g., irradiation, chemical mutagenesis, heat treatment, etc.).
The specification only describes cucumber NUN 53040 CUP. The parental lines of NUN 53040 CUP and the breeding history are not described. NUN 53040 CUP does not further comprise any mutations by mutagenesis.
In the art, mutagenesis techniques introduce genomic modifications in a random and unpredictable fashion, which will certainly not resemble the starting variety either genetically or phenotypically.
For example, Mou (Mutations in Lettuce Improvement. International Journal of Plant Genomics, p1-7, 2011) demonstrated that random mutagenesis, naturally occurring, or induced by chemical (EMS) and physical (Gama ray) mutagens, caused major changes of physiological and morphological characteristics in lettuce including dwarf, male sterile, reduced diameter, loss of resistance to disease and so on (page 2, table 1).
For another example, Meric et al (Profile‑based proteomic investigation of unintended effects on transgenic and gamma radiation induced mutant soybean plants. Genet Resour Crop Evol 70: p2077–2095, 2023) teach and demonstrated that mutagenesis by gamma ray to plants caused significant changes in expression of many proteins in the resultant mutants (p2086-2089, Fig 4). Meric et al demonstrated and summarized that both mutagenesis and transgene introduction lead to (random and unintended) changes in metabolic functions of differential expressed proteins as compared to that of the control plants (p2086-2089, Fig 4; p2089, fig 5). Meric et al further teach and demonstrated that gamma irradiation causes mutations in multiple sites simultaneously and induces genome-wide variations compared to transgenesis (p2092, right col, 2nd para). Thus, mutagenesis by gamma rays does not lead to a single mutation.
Thus, NUN 53040 CUP comprising random mutations by mutagenesis does not likely otherwise maintain the physiological and morphological characteristics of the original NUN 53040 CUP.
Regarding the representative number of species, again, the specification only describes NUN 53040 CUP, the parental lines of NUN 53040 CUP and the breeding history are not described.
Since mutations are random and can be in all positions of the genome, and can have insertions, deletions, and substitutions of any size and structure, the genus of plants produced by mutagenesis, thus the number is near infinite.
NUN 53040 CUP does not demonstrate the characteristics of the genus of mutant plants by mutagenesis. NUN 53040 CUP also is not sufficient to represent the genus of the genus of mutant plants by mutagenesis.
Given the lack of disclosure of broadly claimed genus as discussed above, any ordinary skill in the art would not have recognized that the applicant had the possession of the genera as claimed. Therefore, the application has not met either of the two elements of the written description requirement as set forth in the court' s decision in Eli Lilly, and has not shown her/his possession of the claimed genera.
Remarks
By name search, instant cucumber variety NUN 53040 CUP has no prior art in patent, patent application or NPL. instant cucumber deposit NCIMB 44140 has no prior art in patent, patent application or NPL.
Prior art does not disclose any corn has all of the physiological and morphological characteristics of instant NUN 53040 CUP/ NCIMB 44140.
Claim 17 is not rejected under 35 USC 101, because the plant of claim 1 NUN 53040 CUP has no prior art and appears to be a new plant. Thus, determining the genotype is not deemed a routine method.
However, the breeding history and parental lines of instant NUN 53040 CUP are missing in the instant specification. When such breeding history and parental lines become available (See the 112a rejection above), the examiner will perform further search.
Contact information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WAYNE ZHONG whose telephone number is (571)270-0311. The examiner can normally be reached 8:30am to 5:00pm EST.
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, Bratislav Stankovic, can be reached on 571-270-0305. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Wayne Zhong/
Primary Examiner, Art Unit 1662