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 .
DETAILED ACTION
1. The Office acknowledges the receipt of Applicant’s amendment filed August 27, 2025. Claims 1-15 are pending and are examined in the instant application.
All previous rejections not set forth below have been withdrawn.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
This action is made FINAL.
Claim Rejections - 35 USC § 112(a)
2. Claims 1-15 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 instant Specification fails to satisfy the written description requirement of 35 U.S.C. § 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 breeding history for the instantly claimed plant variety. Specifically, in claim 1, Applicant claims a new pepper plant variety. A plant variety is defined by both its genetics (breeding history) and its traits. In the instant application, Applicant has only provided a description of the plant traits as shown in the specification. The instant application is silent or 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”, USDA, https://www.ams.usda.gov/services/pv po/application-help/apply, downloaded 05/01/2023, (previously cited)). 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 (UPOV, Explanatory Notes on Essentially Derived Varieties Under the 1991 Act of the UPOV Convention, April 6, 2017, See UPOV EDV Explanatory Notes 14 and 30 (previously cited)). 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 the plants are 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) (W) and Ex Parte McGowen Board Decision in Application 14/996,093, decided June 15, 2020 (previously cited)). 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 et al. (Plant Physiology, Feb. 2011, Vol. 155, pp. 645-655 (previously cited)) teaches that the assumption that elite cultivars are composed of relatively homogenous genetic pools is false. (p. 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 (p. 645, right column and p. 646, left column). In addition to genetic variation, environmental variation may lead to phenotypic variation within a cultivar. (Großkinsky et al., J. Exp. Bot., Vol. 66, No. 11, pp. 5429-5440, 2015 (previously cited), p. 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 to 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/drawing to provide the breeding history used to develop the instant variety, line 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. All other potential names for the claimed variety should also be set forth. 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 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 variety should be set forth.
Applicant is 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). If there any patent applications or patents in which sibs or parents of the instant plant are claimed, the serial numbers and names of the sibs or parents should be disclosed. This information can be submitted in an Information Disclosure Statement (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).
Applicant’s disclosure is insufficient because it does not address all the issues set forth above.
Correction is required.
Applicant’s Traversals
Applicant traverses primarily that the requirements of a Plant Patent or Plant Variety Protection Application are not applied to a Utility Application; it has not been the practice of the Office to apply them to a Utility Application; Applicant has submitted the breeding history information as a Trade Secret to satisfy the examination requirements of the Office; and Applicant’s submission is consistent with the Office’s practice.
Response to Applicant’s Traversals
Applicant’s traversals have been considered but are deemed unpersuasive for the following reasons.
The above cited documents were not relied upon to determine the requirements for a plant utility application or for legal precedence. They were considered to determine the state of the art as to what is adequate description for a plant variety. The Office has made a finding of fact that for the instant variety, the minimum description is the combination of the phenotype and genotype (breeding history). To support the finding of fact, the Office has cited other plant-related intellectual property organizations (USDA, UPOV) and relevant court cases (Ex parte C, Ex Parte McGowen) dealing with plant varieties in which both the phenotype and genotype were analyzed. Haun et al. and Großkinsky et al. were cited to show that a trait table is insufficient to differentiate varieties by itself, because intracultivar heterogeneity exists in crop species and environmental variation may lead to phenotypic variation within a cultivar. The Office did not cite these finding to clarify the law. They are solely to clarify the finding of fact: that is, what is an adequate written description for the instant plant variety?
The facts are as follows. The claims indicate seeds representative of hybrid pepper variety E20S.10382 are deposited. The claims are not directed to the deposited seeds or plants grown therefrom. Neither the Specification nor the claims indicate that the claimed seed is genetically identical to the deposited seeds. When two inbred parents are crossed, one skilled in the art would reasonably expect to obtain a population of progeny plants that shares most of the phenotypic characteristics but are not necessarily genetically identical due to naturally-occurring genetic and environmental factors. Thus, the recitation of “E20S.10382” in the claims is understood by the Office to encompass a genus of seeds/plants that are not are not genotypically identical. Additionally, paragraph [0069] states “When the term pepper plant, hybrid, cultivar or pepper line are used in the context of the present disclosure, this also includes any single gene conversions.” This statement indicates that the claimed genus of plants do not necessarily have all the morphological and physiological characteristics of hybrid variety E20S.10382 as disclosed in the Specification. In fact, the Specification goes on to state that the claimed plant has “essentially all of the desired morphological and physiological characteristics of a cultivar [0069], whereby “essentially” and “desired” are not defined. Furthermore, Applicant acknowledges these characteristics are influenced by environmental conditions [0055]. In addition to encompassing a genus of plants that do not have the same genotype or phenotype, the Specification is silent with regard to the breeding history of hybrid variety E20S.10382, including the parent plants used to produce the claimed hybrid variety and their public availability.
35 USC 112(a) clearly states “The specification (emphasis added) shall contain a written description of the invention”. A Trade Secret submission cannot satisfy this statutory requirement because said submission is not part of the specification. MPEP 2163(I) states “a showing of possession alone does not cure the lack of a written description”, citing Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956, 969-70, 63 USPQ2d 1609, 1617 (Fed. Cir. 2002). “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." (Quoting the Deposit of Biological Materials for Patent Purposes, Final Rule, 54 Fed. Reg. 34,864 (August 22, 1989) at 34,880). An adequate written description precludes the issuance of a patent that would otherwise issue due to Applicant’s omission of critical information from the Specification.
The prior art teaches numerous hybrid pepper varieties that share many or most of the commonly disclosed phenotypic traits. Due to these phenotypic similarities, the Office needs more specific breeding history to distinguish the claimed genus of plants of variety E20S.10382 from other plants.
Therefore, the question is not whether one skilled in the art can distinguish the claimed plant from other plants, but whether one skilled in the art can distinguish the genus of claimed plants from other plants. The disclosure of the parents, i.e., breeding history, used to produce the claimed genus is an essential component for determining the patentability of the claimed genus. It should be noted that Applicant does not provide marker information to distinguish the claimed genus of plants from other plants when Applicant is in the best position to do so. Polymorphisms exist within the genus of plants claimed. Applicant’s failure to provide this information is evidence that it is not practical to do a marker analysis to distinguish plants from one another.
Henceforth, the above requested information is material for patentability.
Accordingly, the rejection is maintained.
3. Claims 3, 6, 8 and 9 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 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 3, 6 and 9 encompass an F1 progeny embryo and seed cell of hybrid pepper E20X.10382. The genome of hybrid pepper E20X.10382 is heterologous at every locus. When hybrid pepper E20X.10382 is crossed with an unknown parent, it is unpredictable what genetic material its F1 progenies would inherit. The specification does not disclose a representative number of F1 progenies of hybrid pepper E20X.10382 to allow one skilled in the art to predict the genetic makeup or physiological and morphological characteristics of the claimed F1 progenies. No identifying characteristics are set forth for the F1 progenies. There are insufficient relevant identifying characteristics to allow one skilled in the art to predictably determine the genomic structure or morphological and physiological characteristics of the claimed F1 progenies, absent further guidance. Accordingly, the claimed seed, cell (seed or embryo cell) and protoplast (seed or embryo cell) of hybrid pepper E20X.10382 lack adequate written description.
With regard to claims 3, 6 and 8, directed to a pollen grain, these claims lack adequate written description because Applicant is claiming haploids of hybrid pepper E20X.10382. The genome of hybrid pepper E20X.10382 is heterologous at every locus. During meiosis to produce the haploid pollen, it is unpredictable which reassortment of dominant and recessive alleles of hybrid pepper E20X.10382 would be present in the pollen. One skilled in the art cannot predict the genetic makeup of the claimed pollen, or the morphological and physiological characteristics of a plant produced by doubling the haploid chromosomes of the pollen. Accordingly, the claimed pollen grain is not adequately described.
For the above reasons, there is a lack of adequate description to inform a skilled artisan that Applicant was in possession of the claimed invention at the time of filing. See https://www.uspto.gov/sites/default/files/web/menu/written.pdf.
Applicant’s traversals
Applicant traverses primarily that the claims recite parts that are physically connected with the plant, and they are possessed by virtue of possessing the plant from which they are a part.
Response to Applicant’s traversals
Applicant’s traversals have been considered but are deemed unpersuasive for the following reasons.
The plant part of claim 1 encompasses F1 progeny seed and F1 embryo that are physically connected to the plant. However, the seed and embryo on said plant are produced from hybridization of a plant of hybrid variety E20S.10382 with an undisclosed plant. The seed and embryo present on the plant of hybrid variety E20S.10382 have only half of the hybrid genome of variety E20S.10382, the other half being from an undisclosed plant, and would produce a plant having significantly different morphological and physiological characteristics from hybrid variety E20S.10382. However, it is not known what these characteristics are. Due to the reassortment of the hybrid genome of variety E20S.10382 (the first parent plant), and no genotypic or phenotypic information for the second parent plant, it is highly unpredictable what genotypic or phenotypic characteristics said seed and embryo have. Accordingly, the seed and embryo present on the plant lack adequate written description. Similarly, the pollen grain present on a plant of hybrid variety E20S.10382 has only half of the genome of said plant. Because hybrid variety E20S.10382 is heterologous at every allele, it is unpredictable what combination of dominant and recessive alleles from the hybrid genome is present in each pollen grain. Thus, the haploid pollen grain present on a plant of hybrid variety E20S.10382 lacks adequate written description.
MPEP 2163(I) states “a showing of possession alone does not cure the lack of a written description”. In the instant application, no information whatsoever is disclosed for the claimed F1 progeny seed/embryo or haploid pollen grain of hybrid variety E20S.10382. Accordingly, the rejection is maintained.
Conclusion
4. No claim is allowed.
5. THIS ACTION IS MADE FINAL. 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.
6. Any inquiry concerning this communication or earlier communications from the examiner should be directed to PHUONG T BUI whose telephone number is (571)272-0793. The examiner can normally be reached on M-F 8am-5pm.
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/PHUONG T BUI/Primary Examiner, Art Unit 1663