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 10/4/2024 have been entered and considered. Initialed copies of the form PTO-1449 are enclosed with this action.
Status of claims
Claims 1-27 are pending and examined.
Priority
Instant application 18767758, filed 07/09/2024, claims Priority from Provisional Application 63513017, filed 07/11/2023, which is recognized.
Interpretation of claim 3
In the claim, “a plant of inbred broccoli line BP-2” is interpreted as a plant grown from the seed wherein a representative sample of seed of said inbred broccoli line was deposited under NCMA No. 202311015, in the same claim.
Claim Objections
Claim 2 is objected for the following informality:
It is suggested to change “produced by the seed of claim 1” to --- produced by growing the seed of claim 1 ---.
See claims 8 and 11, for example.
See the requirement of 37 CFR 1.71(a) for “full, clear, and exact terms”.
Appropriate correction is required.
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 1-27 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 inbred broccoli line BP-2.
In the instant application, 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 BP-2, 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 a “Variety Description Information” of representative traits of BP-2 ([0038], Table 1). However, instant specification does not describe the breeding history, particularly the parent line(s), of the claimed BP-2. 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.
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 broccoli plant, or example, Nandhini et al (Assessment of variability in Broccoli (Brassica oleracea var. italica L.) genotypes. The Pharma Innovation Journal 9(1): p338-340, 2020) tested 13 different genotypes of broccoli, and found that “the analysis of variance revealed significant differences among the 13 genotypes for all the traits studied” (p339, right col, 1st para, Table 1). Nandhini et al teach that the presence of genetic variation in the breeding material determines the success or failure of any breeding program. Therefore, the measurement of genetic variation and understanding the mode of inheritance of qualitative and quantitative traits are the essentials in any crop improvement program (p338, 1st para; p340, left col, 1st 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 broccoli 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).
Claims 7-8, 10-11 are 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.
To claim a genus under the written description requirement, the applicant is required to describe a representative number of species to reflect the variation within the genus or structures sufficient to define the genus. The factors to be considered include disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, or any combinations thereof.
By court' s statement in Regents of the Univ. of Cal. v. Eli Lilly, 119 F.3d 1559, 1566, 43 USPQ2d 1398, 1404 (Fed. Cir. 1997), a written description of an invention “requires a precise definition, such as a structure, formula, or chemical name, of the claimed subject matter sufficient to distinguish it from other materials”; further, a written description of a claimed genus requires a description of a representative number of species of the claimed genus, and one of skill in the art should be able to “visualize or recognize the identity of the members of the genus”.
Regarding claims 7-8, claims are broadly drawn to a genus of seeds and plants produced by the method of claim 6 (crossing the plant of claim 3, BP-2, with a different broccoli plant).
The specification only describes a “Variety Description Information” of representative traits of BP-2, and describe a “Variety Description Information” of XBC8586 ([0038], Table 1). As analyzed above, the genetic background of BP-2 is not disclosed in the specification.
Claims do not limit the seed and plant to F1 generation. Thus, the seeds and plants encompass F2 generation and beyond.
According to the specification ([0038]), XBC8586 is a F1 hybrid produced from a three-way cross of BP-1 with BP-2, CMS-BP-1 (BP-2 and CMS-BP-1 are different but specific broccoli plants).
XBC8586 is the only species of crossing instant BP-2 with a different broccoli plant). Please note that the morphological characteristics of XBC8586 is different from that of BP-1, BP-2 or CMS-BP-1 under the same growing condition. For example, BP-1 has greyish olive green cotyledon color, BP-2 moderate yellow green, and XBC8586 greyish olive green. For another example, BP-1 has a plant height of 54, BB-2 45, and XBC8586 60 ([0039], Table 1).
The specification does not describe any species other than XBC8586.
In the art, Han et al (Advances in Genetics and Molecular Breeding of Broccoli. Horticulturae, p1-18, 2021) teach that Broccoli displays obvious heterosis and most commercial broccoli varieties are F1 hybrids (p5, 5th para), and that in F2, F3 generations, high rate of segregation population occurs (p7, 3rd para).
Thus, the claimed plants that are F2 and beyond generations have complicated genetic changes leading to nearly unpredictable genetic background, and such changes lead to unpredictable changes in physiological and morphological characteristics of the original broccoli plant.
Regarding claims 10-11, claims are broadly drawn to a genus of seeds and plants produced by the method of claim 9 (selfing the plant of claim 3, BP-2).
Claims do not require the seed and plant to be F1 generation, and do not require that the seed producing the plant, and the plant growing from the seed, comprising all of the physiological and morphological characteristics of BP-1 broccoli.
The specification only describes a “Variety Description Information” of representative traits of BP-2 ([0038], Table 1). As analyzed above, the genetic background of BP-2 is not disclosed in the specification.
Please note that BP-2 as deposited under NCMA 202311015 is an original, not an inbred. The specification does not describe any inbred of BP-2.
In the art, Achrem et al (Epigenetic Changes Occurring in Plant Inbreeding. Int. J. Mol. Sci. P1-17, 2023) teach that in diploid (broccoli is a diploid, 2n=18) organisms, self-pollination causes heterozygosity to be halved in each generation (p4, 3rd para). Inbred lines also provide a component for crossing to induce heterosis among them (p5, 4th para).
Thus, at the very least, not all self or inbred lines maintain their genotypes or their physiological and morphological characteristics, from the original line.
Regarding the description of a representative number of species, BP-2 is the original line. XBC8586 is the only described hybrid line of crossing BP-2 with another plant. There is no described line by selfie.
Since the second plant as claimed is generic not specific, and the progenies of F2 (F3, F4, F5 ….. and more) and beyond are unlimited, the genus of seeds and plants in claims 7-8 have extremely large number, and heterologous in structure.
Since the generation of selfie is unlimited, and the claims do not require that the seed producing the plant, and the plant growing from the seed, comprising all of the physiological and morphological characteristics of BP-2 broccoli, the genus of seeds and plants in claims 10-11 have extremely large number, and heterologous in structure.
The only describe species, BP-2 or XBC8586, does not describe the common structure feature of the heterologous genus, and is not sufficient to represent the heterologous genus.
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 genus at the time of the application.
Note: amend claim 7 to ---an F1 broccoli seed--- in claim 7, and
amend claim 10 to recite ---producing a plant comprising all of the physiological and morphological characteristics of BP-2---,
would overcome the rejections.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the claims at issue are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 15-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 15-19 of co-pending Application No. 18767320/USPGPUB 20250017160.
The instant and co-pending applications share the same inventor, and the same applicant Sakata Seed Corp.
The co-pending application claims (as 7/9/2024).
15. A method for producing a seed of a broccoli plant derived from inbred broccoli line BP-1 comprising the steps of:
(a) crossing the broccoli plant of claim 3 with itself, a second broccoli plant and a third plant; and
(b) allowing seed of a broccoli plant derived from inbred broccoli line BP-1 to form.
16. The method of claim 15, further comprising the steps of:
(c) sowing a plant grown from said seed of said broccoli plant derived from inbred broccoli line BP-1 to yield seed derived from said inbred broccoli line BP-1;
(d) growing seed of step (c) to yield additional broccoli plants derived from inbred broccoli line BP-1.
17. The method of claim 15, wherein said second broccoli plant is an inbred broccoli plant of a different line, and wherein the method further comprises:
sowing said seed from said broccoli plant derived from inbred broccoli line BP-1; and
growing said broccoli seed yield a hybrid broccoli plant.
18. The method of claim 15, wherein said second broccoli plant is inbred broccoli line BP-2, wherein a representative sample of seed of said inbred broccoli line BP-2 was deposited under NCMA No. 202311014 broccoli line.
19. The method of claim 18, wherein said hybrid broccoli plant is hybrid broccoli line XBC8586.
Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding claims 18-19, both applications claim a method of producing hybrid broccoli line XBC8586, by using the same parent lines BP-1/NCMA 202311014 and BP-2/NCMA 202311015.
Regarding claims 15-17 that are more generic and broader than claims 18-19, the BP-1 of co-pending application is a specific species of the “second broccoli plant” of instant claims 15-18; the BP-2 of instant application is a specific species of the “second broccoli plant” of co-pending claims 15-18.
In addition, the co-pending and instant applications have essentially the same claim language.
Therefore, the claims are obvious over each other in co-pending and instant applications.
Remarks
Both instant application and co-pending application 18767320 were filed the same day, 7/9/2024. However, the IDS filed on 10/4/2024 by the applicant did not disclose the co-pending application. Upon further consideration, the co-pending application 18767320 and instant application are searched and examined side by side.
By name search, instant broccoli BP-2, along with broccoli BP-1, was published in the applicant’s website https://sakatavegetables.com/patents/. However, it appears that the document was published 9/2/2022 by the applicant, thus, is a 102 (a)(1) exception. See attached PDFs.
Otherwise, instant BP-2 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 BP-2.
However, the breeding history and parental lines of instant BP-2 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. Art and/or more double patenting rejections may be made.
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.
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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