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 .
This is a Final Office Action in response to amendment filed on 8/27/2025. Claims 11, 12, and 14 are amended. New claims 23 and 24 are added. Claims 1-24 are pending and examined herein.
Response to Amendment
The rejection to claims 1-22 under 35 U.S.C. § 112(a), regarding the enablement requirement of Biological Deposit is withdrawn in view of Applicant’s statement in Remarks and the corresponding amendment to the Specification.
The rejection to claims 12, and 14-18 are rejected under 35 U.S.C. 112(a) is withdrawn in view of amendment to the claims.
Claim Rejections - 35 USC § 112
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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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.
Written Description Regarding Missing Breeding History
Claims 1-22 remain, and 23-24 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 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 “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 2163(I) states “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).
In the instant application, a full examination cannot be conducted because applicant failed to provide the full breeding history for the instantly claimed plant variety. Specifically, in claim 1, Applicant claims a broad genus of new tomato plant variety. A plant variety is defined by both its genetics (breeding history) and its traits.
It is noted that at least for claim 1, Applicant claims any hybrid progeny plant of tomato line FDR-XJ19-7159, or any hybrid progeny plant tomato line FDS-XJ15-6051. It should be noted that the plant of tomato hybrid SVTE8804 is only one species of this broad genus, requiring both parents FDR-XJ19-7159 and FDS-XJ15-6051.
In the instant application, applicant only provided a description of the physiological and morphological characteristics for tomato hybrid SVTE8804, tomato line FDR-XJ19-7159, and
FDS-XJlS-6051 (e.g., Table 1). However, the Specification does not describe the parental lines was used to breed for the tomato line FDR-XJ19-7159; the parental lines was used to breed for the tomato line FDS-XJlS-6051; and the breeding method and process by which the lines FDR-XJ19-7159 and FDS-XJlS-6051 were obtained, and if either or both of the lines FDR-XJ19-7159 and FDS-XJlS-6051 have any other known designation. Therefore, the instant application is incomplete as to the breeding history used to produce the claimed plant variety.
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 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” 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 variety. Historically, the USPTO has considered breeding history information when determining the patentability of a new plant variety. (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 variety. 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.
As seen above in Ex Parte C and Ex Parte McGowan, a trait table is insufficient to differentiate varieties by itself. It has been long established that intracultivar heterogeneity exists in crop species. HAUN teaches that the assumption that elite cultivars are composed of relatively homogenous genetic pools is false. (See Haun Page 645 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. (See Haun Page 645 right column and Page 646 left column). In addition to genetic variation, environmental variation may lead to phenotypic variation within a cultivar. (See Großkinsky page 5430 left column 1st full paragraph and right column 2nd full paragraph). In view of this variability, a breeding history is an essential and the least burdensome way to provide genetic information needed at adequately describe a newly developed plant.
Thus, an application that does not clearly describe the breeding history does not provide an adequate written description of the invention.
To overcome this rejection, applicant must amend the Specification or Drawing to provide the breeding history used to develop the instant variety or cultivar. 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 variety. For example, if applicant’s breeding history uses proprietary line names, 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, 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 is also reminded that they have a duty to disclose information material to patentability. 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 as information submitted as described in MPEP 724 (e.g., trade secret, proprietary, and Protective Order).
Response to Applicant’s Remarks:
Applicant traversed the rejection above by offering various lines of arguments. These arguments have been fully considered but not deemed persuasive.
Firstly, Applicant argued that “[T]he entire genetic contribution of tomato line FDR-XJ19-7159 and tomato line FDS-XJ15-6051 is described in the specification by way of deposit of the lines. As described at least in paragraphs [0018-0020] of the specification, all plants having at least a first set of the chromosomes of tomato line FDR-XJ19-7159 and tomato line FDS-XJ15-6051 will share the same haploid genetic complement received from the line.” (Remarks, p. 3, para. 2; emphasis added by Examiner). It should be noted that claims are drawn to “tomato plant comprising at least a first set of the chromosomes of tomato line FDR-XJ19-7159 or tomato line FDS-XJ15-6051,” e.g., in independent claims 1, 15 and 17. The claims use of “or” to indicate the tomato lines as alternatives. Therefore, the claimed “tomato plant” to comprise any tomato plant having either of the two deposited lines as a parent, while the other parental line could be any tomato lines, or cultivars (or even wild tomato isolates). Thus, the claims encompass a broad range of tomato plants. In contrast, Applicant has only described one hybrid plant designated as SVTE8804 (which has not even been deposited). Applicant has not taught how what other hybrid plants should be made and selected.
Applicant also argued that the rejection is contradictory to the instructions by Ex Parte C. However, Applicant has cited, from Ex Parte C: “The claimed soybean is described in the specification to the extent that there is no question that appellant was in possession of the invention as of the time the instant application was filed.” It should be noted that as discussed above, the instantly claimed broad genus of hybrid tomato, has not been “described in the specification to the extent that there is no question that appellant was in possession of the invention as of the time the instant application was filed.”. Thus, this argument has not been found persuasive.
Applicant further argued that “These genetic complements are readily identifiable, for example, by genetic marker analysis, and represent a description of the concrete and identifiable structural characteristics defining the claimed plants and distinguishing them from other plants.” However, Applicant has not described any genetic marker or the “concrete and identifiable structural characteristics defining the claimed plants and distinguishing them from other plants.” Instead, as Applicant admitted, only “the exemplary morphological and physiological characteristics of the lines are described at least in Table 1 of the specification”. Therefore, it is contradictory to Applicant’s assertion that the full complement of identifiable features have been described.
Applicant lastly argued that “all of the members of the claimed genus of tomato plants and seeds share the structural feature of having at least the haploid genetic complement of tomato line FDR-XJ19-7159 and tomato line FDS-XJ15-6051. One of skill in the art viewing the specification could thus readily identify the members of the genus.” As Applicant admitted, The Federal Circuit has noted that such “shared identifiable structural features are important to the written description requirement”. The claimed broad genus of hybrid tomato plants only has either one of the deposited lines as parent. The other parent has to be selected and the performance of the hybrid has to be predicted, both highly complex. For example, “Selecting elite parents is of paramount importance in cross- and hybrid-breeding programs. The selection of parents from a phalanx of inbred lines, however, is extremely laborious and time-consuming and can be random. Adding to this complexity, parents with excellent agronomic traits do not always pass those traits on to their progeny. ” (Song, Gaoyuan, et al. "The phenotypic predisposition of the parent in F1 hybrid is correlated with transcriptome preference of the positive general combining ability parent." BMC genomics 15.1 (2014): 297.). The concepts of general combining ability (GCA) allows the study and comparison of the performances of inbred lines in hybrid combination, which is used to designate the average performance of an inbred line in hybrid combination, However, Song teaches that although “GCA is widely recognized and applied to crop and livestock improvement by breeders, it is based largely on breeding experiences, and therefore, it highly is unpredictable”. Since Applicant has not taught the full complement of identifying features of the parental lines, the full scope of the claimed hybrid plants are not enabled.
At least for these reasons, the rejection is maintained.
Conclusion
No claims are allowed.
Claims 1-24 remain provisionally free of the prior art, for the reasons stated in the previous Office Action.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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WEIHUA . FAN
Examiner
Art Unit 1663
/WEIHUA FAN/Examiner, Art Unit 1663