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 .
Duty to Disclose
Applicant is reminded of their “Duty of Disclosure, Candor, and Good Faith” (see 37 C.F.R. § 1.56 and MPEP § 2001). Information that would be considered pertinent to patentability includes: 1) any progeny, siblings, half-siblings, or other closely genetically related plants that are either co-pending applications or previously published or publicly disclosed, 2) if the parental varieties that are crossed to arrive at the instantly claimed hybrid were developed via backcrossing this should be disclosed along with the grandparents, including which grandparent was the recurrent parent along with any publications or public disclosures of the recurrent parent and what events/loci/transgenes/traits were donated from the non-recurrent parent, 3) if there is a locus converted or multiple loci converted between the deposited seeds and the seeds used for the parents of the plants grown for the trait table in the specification, then Applicant should specify which loci were converted and which traits differ when compared to F1 hybrid plants produced by crossing the non-converted parents whose seed is deposited, 4) any alternative designations, experimental names, tradenames, etc. for the instant plant, parent plants, and grandparent plants should be disclosed. All of this information is pertinent to patentability. If, for example, one of the parent plants is published but with a different name/designation, then the publication should be included in the IDS along with an explanation that the different name/designation is a synonym and how this plant is related to the instantly claimed plant.
Specification
The Specification is objected to because in paragraph [0001] on page 1, “priority to” should be -- benefit of -- under 35 USC 119(e).
The disclosure is objected to because of the following informalities:
The specification fails to recite breeding history (see lack of written description rejection below).
Appropriate correction is required.
Applicant is reminded of The Duty of Candor and Good Faith. 37 C.F.R. 1.56.
Information Disclosure Statement
The listing of references on pages 38-40 of the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Deposit Statement
This application requires public availability of specific biological material to make and use the claimed invention. A rejection under the appropriate sections of 35 USC 112 would have been made but for Applicant’s statement on pages 40-41 of the Specification indicating that an acceptable deposit of the specific biological material in compliance with the requirements under 37 CFR 1.801-1.809 has been made with a recognized IDA, at or before the payment of the issue fee, in the event that the application should be determined to be allowable.
Claim Objections
Claim 8 is objected to because of the following informalities:
Claim 8 recites “first progeny” and seems to have omitted the word “generation.” Paragraph [0039] of the specification discusses plants made in a manner as delineated in claim 8 and it refers to a “first generation progeny.” It appears that that the word “generation” was unintentionally omitted when drafting claim 8.
Appropriate correction is required.
Lack of Written Description – Breeding History
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.
Claims 1-20 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.
35 USC 112 (a) states that “The specification shall contain a written description of the invention”. In evaluating written description, the threshold question is what is “an adequate written description”. This is question of fact that is evaluated by the factfinder (examiner). MPEP 2163.04 clearly states that “The inquiry into whether the description requirement is met must be determined on a case-by-case basis and is a question of fact. In re Wertheim, 541 F.2d 257, 262, 191 USPQ 90, 96 (CCPA 1976).”
The instant invention is a new lettuce variety (NUN 09208 LTL). So, the examiner will evaluate what is an adequate written description for a new lettuce variety. In reviewing this question of fact, the examiner analyzed how plant varieties are evaluated in the public domain. The review concluded that generally the minimum requirements for an adequate description of a new plant variety has a trait descriptions and genetic information (via a breeding history). In reviewing applicant’s specification there is a phenotypic description as is seen in Table 1. However, the provided breeding history in the specification in Spec, page 40, paragraph [0167] is generic. There are no names of the parental varieties disclosed, nor were the specific breeding steps used in development of the instantly claimed variety.
Because the specification lacks a specific breeding history and that breeding history is part of the minimum description of a plant variety the applicant has not fulfilled the requirement of 35 USC 112(a) to provide a written description in the specification. The office’s reasonable basis for challenging the adequacy of written description is informed by a review of the following:
With regard to Plant Patents, MPEP 1605 states that a complete detailed description of a plant includes “the origin or parentage”.
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, (U)).
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 (V)).
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 (X)). 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.
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. (Published: 2011, Journal: Plant Physiology, Vol. 155, pp. 645-655 (Y)) 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. (Published: 2015, Journal: J. Exp. Bot., Vol. 66, No. 11, pp. 5429-5440, 2015 (Z), 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.
The above factual evidence provides a reasonable basis that a breeding history is necessary written description. With this information the examiner has met the initial burden of presenting by a preponderance of evidence why a person of ordinary skill in the art would not recognize in an applicant’s disclosure a description of the invention defined by the claims. (See MPEP 2163.04). Please note, the citations above are not for legal authority, the legal authority relied upon by the examiner is the 35 USC 112(a) statute. The citations are presented to support the finding of fact that a breeding history is necessary to the adequate description of a plant.
Although not directly relied upon for the above written description position, a complete written description additionally helps drive examination and help with infringement verification.
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).
The breeding history aids 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.
Moreover, a specification devoid of a complete 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 complete 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.
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 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 cultivar and all other potential names for the claimed cultivar. If Applicant’s breeding history uses proprietary cultivar names, Applicant should notate in the specification all other names of the proprietary cultivars, especially publicly disclosed or patented cultivar 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 cultivar). 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 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).
35 USC 112(a) clearly states “The specification (emphasis added) shall contain a written description of the invention”. In the instant application, the Specification fails to provide any breeding history. Moreover, the claims indicate Applicant intends to deposit seeds representative of the claimed cultivar. Thus, the claims are not directed to the deposited seeds or plants grown therefrom. The claims are directed to a genus of lettuce plants and seeds that are genotypically and phenotypically different from the deposit, and have different traits from those disclosed in the specification. Given these differences, the complete breeding history for producing the claimed cultivar, including all names for the parents and for the claimed cultivar, are material for patentability. A specification devoid of a complete breeding history hampers the public’s ability to fully resolve questions of infringement.
Lack of Written Description
Claim 16 is 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 16 is drawn to lettuce plants produced by processes that introduced at least one mutation in at least one target gene of lettuce line “NUN 09208 LTL” without any upper limit to the number of mutations introduced to lettuce line “NUN 09208 LTL”.
This means that plants sharing little genetic and phenotypic characteristics are included in the scope of the claims.
The instant disclosure describes a few characteristics and traits of “NUN 09208 LTL” (Table 1).
This description is insufficient, because there is not any limit on how dissimilar the resultant plants are from the deposited variety.
Given the broad scope of the claimed genus one of skill in the art would not have recognized that Applicant was in possession of the claimed genus at the time of filing.
Scope of Enablement
Claim 8 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for producing a first progeny plant that has all of the physiological and morphological characteristics of NUN 09208 LTL when NUN 09208 LTL is bred with itself, does not reasonably provide enablement for producing a first progeny plant that has all of the physiological and morphological characteristics of NUN 09208 LTL when NUN 09208 LTL is bred with another lettuce plant. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
The claimed invention is not supported by an enabling disclosure taking into account the Wands factors. In re Wands, 858/F.2d 731, 8 USPQ2d 1400 (Fed. Cir. 1988). In re Wands lists a number of factors for determining whether or not undue experimentation would be required by one skilled in the art to make and/or use the invention. These factors are: the quantity of experimentation necessary, the amount of direction or guidance presented, the presence or absence of working examples of the invention, the nature of the invention, the state of the prior art, the relative skill of those in the art, the predictability or unpredictability of the art, and the breadth of the claim.
The claims are drawn to “first progeny” of the lettuce plant of claim 1 obtained by crossing the plant of claim 1 with itself or another lettuce plant wherein the “first progeny” has all of the physiological and morphological characteristics of NUN 09208 LTL.
It is impossible to produce a first progeny plant that has all of the physiological and morphological characteristics of NUN 09208 LTL when NUN 09208 LTL is bred with another lettuce plant. Half of the genetics would be imparted by another lettuce plant that has distinct genetics from NUN 09208 LTL. The result progeny necessarily has some physiological and morphological characteristics that differ from NUN 09208 LTL as one half of its genome is from another lettuce plant.
Neither the state-of-the-art nor the instant disclosure provide teaching that can make up for the impossibility claimed.
Given the lack of guidance in the instant specification, undue trial and error experimentation would have been required for one of ordinary skill in the art to produce a first progeny plant that has all of the physiological and morphological characteristics of NUN 09208 LTL when NUN 09208 LTL is bred with another lettuce plant.
Therefore, given the breadth of the claims; the lack of guidance and working examples; the unpredictability in the art; and the state-of-the-art as discussed above, undue experimentation would have been required to practice the claimed invention, and therefore the invention is not enabled throughout the scope of the claims.
Summary
No claims are allowed.
The claims appear to be free of prior art. The closest prior art is Zee et al. (US Patent Application Pub. No.: US20230126943A1, Pub. Date: 04/27/2023) which teaches a lettuce variety NUN 09187 LTL which has many of the similar traits of the examining cultivar NUN 09208 LTL (see Table 1, pages 17-19). The distinctions in traits are the Zee et al.’s lettuce variety NUN 09187 LTL has black seed color, bolting is late and lacks resistance to Fusarium oxysporum sp. lactucae Race 1 etc. However, a complete search at this time is not possible because applicant have not provided any breeding history of the applicant’s lettuce cultivar NUN 09208 LTL.
Examiner’s Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SANTOSH SHARMA whose telephone number is (571)272-8440. The examiner can normally be reached Mon-Fri 8:00 AM - 5:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, AMJAD A. ABRAHAM can be reached at (571)270-7058. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SANTOSH SHARMA/Examiner, Art Unit 1663
/DAVID H KRUSE/Primary Examiner, Art Unit 1663
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