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 December 23, 2025. Claims 1-31 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All previous rejections not set forth below have been withdrawn.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.
Specification
2. The disclosure is objected to because of the following:
The last sentence in paragraph [0230] is incomplete.
There is a discrepancy in Applicant’s disclosure as to whether line W087YR is an inbred or a hybrid. The Abstract and paragraphs [0001], [0005], [0030] and [0227] state that line W087YR is an inbred. However, paragraphs [0010], [0029], [0036] and [0041] state that line W087YR is a hybrid. This is not an exhaustive list of paragraphs having the discrepancy.
Clarification and/or correction is required.
Claim Rejections – 35 USC § 112(a)
3. Claims 1-31 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) further 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 line. Specifically, in claim 1, Applicant claims a new watermelon plant line. A plant line 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. It should be noted that many of the traits disclosed for watermelon line W087YR cannot be objectively compared with other watermelon lines due to the subjective terms used to describe the traits, e.g., very, short, low, small, medium, weak, strong. The instant application is silent or incomplete as to the breeding history used to produce the claimed plant line.
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) (previously cited) 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 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.
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 line and all other potential names of the instant line. 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 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 line). 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. If the claims encompass a progeny of the instant plant, all patent applications and patents that claim a progeny or progenies of the instant plant must also be disclosed. This information can be submitted in an Information Disclosure Statement 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).
In the instant application, paragraph [0229] merely states “The origin and breeding history of watermelon line W087YR including typical pedigree breeding with crossing and selection of proprietary germplasm.” This is an insufficient disclosure because it does not address the issues set forth above, and a specification devoid of a breeding history hampers the public’s ability to fully resolve questions of infringement.
Correction is required.
Applicant’s Traversals
Applicant traverses primarily the following: (1) Applicant has possession of the claimed invention because a deposit has been made. (2) Paragraphs 229 and 231 of the specification states that the inbred was developed through "pedigree breeding with crossing and selection of proprietary germplasm", and further that "selections were made for testcross performance for high firmness, yield, and brix in Davis and Dixon field trials". (3) In re Argoudelis, 434 F.2d 666 (CCPA 1970) (holding that claims to a method using a specific microorganism satisfied 112 through a public deposit of the microorganism), and the long litany of cases thereafter have all held that a publicly available deposit satisfies both enablement and written description. (4) The deposit provides substantially more genetic information than a breeding history. (5) The public can rely on both the phenotypes of the claimed plant described in the specification and the genetics of the claimed plant through the biological deposit of seeds, for assessing potential infringement. (6) To the extent the Examiner believes the entire breeding history is reasonably necessary for examination, Applicant will provide this proprietary information in accordance with MPEP § 724.02 upon a request for information under 37 C.F.R. § 1.105.
Response to Applicant’s Traversals
Applicant’s traversals have been carefully considered but are deemed unpersuasive for the following reasons.
With regard to traversals (1) and (3), 35 USC 112(a) clearly states “The specification (emphasis added) shall contain a written description of the invention”. A deposit alone does not satisfy the written description requirement. If this were true, then Applicant need not provide any description whatsoever for the claimed line in 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). Applicant’s arguments ask the Office to not consider the actual statute and to base its decision solely on statements from court or Board cases that do not directly decide what is an adequate written description for a plant variety. These arguments are not persuasive.
With regard to traversals (2) and (4), different watermelon varieties share many of the same traits, including high firmness, yield, and Brix which Applicant selected for in the claimed line. Paragraph [0005] states “The disclosure also relates to variants, mutants and trivial modifications of the seed or plant of watermelon line designated W087YR.” Applicant admits that the traits may vary due to environmental influences [0232]. Applicant further states that no variant traits have been observed or expected for important agronomical traits [0232]. However, the term “important agronomical traits” is not defined. It should be noted that the claims are not directed to seeds and plants grown therefrom that are genetically identical to the deposit. Thus, the recitation of “watermelon line designated W087YR” encompasses a genus of plants that are genotypically and phenotypically different from the deposit and from the traits disclosed in the Specification. As no other information is disclosed, and many watermelon varieties share the same morphological and physiological characteristics, the breeding history is essential to distinguish the claimed genus of plants from other plants.
With regard to traversal (5), contrary to Applicant’s allegations, the Patent Owner is not making the genetic sequence (genotype) of the claimed line available because claim 30 would preclude anyone from isolating nucleic acids from line W087YR and performing a marker analysis or DNA sequencing to detect a polymorphism without infringing the claimed invention. If a marker analysis cannot be performed, then Applicant’s assertion that written description can be satisfied by way of the deposit is misleading. Applicant’s claim 30 in effect would make the public an infringer to genotype the instant variety as a means to distinguish their plant from the instant line. Additionally, no genetic marker information is disclosed to distinguish the genus of claimed plants from other plant 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 Applicant’s genus of claimed plants from others.
With regard to traversal (6), 35 USC 112(a) clearly states “The specification (emphasis added) shall contain a written description of the invention”. The strict interpretation of the law is clear. Applicant must provide in the specification a written description. Confidential proprietary information submitted in accordance with MPEP § 724.02 or under 37 C.F.R. § 1.105 cannot satisfy this statutory requirement because such a submission is not part of the specification. Moreover, an adequate written description is not to help the examiner carry out a thorough examination but to preclude the issuance of a patent that would otherwise issue due to Applicant’s omission of critical information from the Specification.
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 M-F 8am-5pm.
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/PHUONG T BUI/Primary Examiner, Art Unit 1663