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 .
Claims 1-24 are pending and examined on their merit herein.
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) The plants utilized in the breeding programs that arrived at the two parental varieties crossed to produce the instant variety (meaning the grandparent varieties), as well as the specific breeding steps/techniques used to arrive at these parent varieties, 2) any progeny, siblings, half-siblings, or other closely genetically related plants that are either co-pending applications or previously published or publicly disclosed, 3) if parental varieties that were crossed to arrive at the instantly claimed variety 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, 5) if there is a locus converted or multiple loci converted between the deposited seeds and the seeds grown to cross to produce the hybrid seeds used for the hybrid plants grown for the trait table in the specification, then Applicant should specify which loci were converted and which traits differ when compared to plants grown from the deposited seeds, 5) any alternative designations, experimental names, tradenames, etc. for the instant plant, parent plants, and grandparent plants should be disclosed. All of this information is material 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.
Claim Objections
Claim 23 is objected to because of the following informalities: Claim 23 recites “a tomato plant or a plant part of cucumber variety NUN 97080 CUL”. It is believed that “tomato” is an editorial error. Also, claim 23 recites “ale sterility” which is believed to be typographic error for “male sterility”. Appropriate correction is required.
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 Requirement regarding Breeding History
Claims 1-24 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 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 cucumber variety NUN 97080 CUL. So, the examiner will evaluate what is an adequate written description for a new cucumber 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 table and genetic information (via a breeding history). In reviewing applicant’s specification there is a phenotypic description as is seen in, e.g., Table 1 and Table 2. However, there is no accompanying breeding history in the specification. Because the specification lacks a 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. (Plant Physiology, Feb. 2011, 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., 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 factual evidence above 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 variety. 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 variety. If Applicant’s breeding history uses proprietary variety 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).
ENABLEMENT
Claims 17-19 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Enablement factors to consider include (1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims. In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988)
Claims 17-18 are drawn to a method of introducing a single locus conversion into the plant of claim 1, comprising crossing the plant of claim 1 with a second cucumber plant comprising a desired single locus conversion to produce F1 progeny plants and repeating one or more times in succession to produce selected second or higher backcross progeny plants; and a cucumber plant produced by the method of claim 17.
Claim 19 is drawn to a method of producing a cucumber plant derived from the plant of claim 1, comprising crossing the plant of claim 1 with itself or with a second cucumber plant; crossing the progeny plant with itself or a different cucumber plant to produce seeds of a progeny plant of a subsequent generation; and repeating for at least one more generation to produce a derived cucumber plant.
Claims 23-24 are drawn to a method of producing a modified cucumber plant, comprising mutating a target gene by targeted gene editing in cucumber variety NUN 97080 CUL.
As disclosed in the Specification, cucumber variety NUN 97080 CUL is a hybrid (Specification, [0178], “The hybrid variety NUN 97080 CUL was developed from a male and female proprietary inbred line of Nunhems. The female and male parents were crossed to produce hybrid (F1) seeds of cucumber variety NUN 97080 CUL.”). Therefore, its genome is heterologous at every locus. Outcrossing of cucumber variety NUN 97080 CUL with an undisclosed parent, e.g., with a second plant, or backcrossing to cucumber variety NUN 97080 CUL, would not regain all or most the morphological and physiological characteristics of cucumber variety NUN 97080 CUL due to the presence of heterologous dominant and recessive alleles at every locus of the genome of hybrid cucumber variety NUN 97080 CUL.
Applicant has no working example of a plant produced by the claimed method. Regarding claims 17-18 and single locus conversion, Paragraph [0093] of the specification states “In case of a hybrid, the gene may be introduced in the male or female parental line.” However, the parent lines of hybrid cucumber variety NUN 97080 CUL are not recited. The state of the prior art does not teach the introduction of a single locus conversion to a hybrid plant by outcrossing and backcrossing to said hybrid plant to produce a converted plant having otherwise all the morphological and physiological characteristics of said hybrid plant. In contrast, the art teaches that the first absolute requirement for a successful backcross program is that the recurrent parent is an inbred line (Plant & Soil Sciences eLibrary 2023, downloaded Aug. 26, 2023 (AA), first page, last paragraph). Otherwise, the recurrent parent goes through meiosis to produce pollen or an ovule, and the genome is not the same as the genome of variety NUN 97080 CUL.
While one skilled in the art can backcross a hybrid progeny to its hybrid parent, there is no guidance as to how many backcrossings to the hybrid parent are required to regain all of its morphological and physiological characteristics in addition to the single locus conversion. It is highly unpredictable what combinations of dominant and recessive alleles at every locus would be present in each backcrossed progeny. Given these difficulties, notwithstanding a relatively high level of ordinary skill of those in the art, the amount of experimentation would likely be extensive and undue.
With regard to claim 23, cucumber variety NUN 97080 CUL is essential to the claimed invention but does not appear to be reproducible by a disclosed method in the specification or readily available to the public. Absent a deposit recitation, one skilled in the art cannot make and use the claimed invention without undue experimentation. Because the method of claim 23 is not enabled, the cucumber plant produced therefrom (claim 24) is also not enabled.
WRITTEN DESCRIPTION
Claim 24 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.
Applicant claims a plant produced by the method of claim 23, which is a method of mutating a target gene by targeted gene editing in cucumber variety NUN 97080 CUL, wherein said target gene modifies a desired trait of male sterility, herbicide tolerance, insect resistance, pest resistance, disease resistance, Powdery mildew resistance without necrosis, environmental stress tolerance, modified carbohydrate metabolism, or modified protein metabolism.
Applicant describes some physiological and morphological characteristics of the cucumber variety NUN 97080 CUL in, e.g., Table 1, and Table 2 of the specification.
Applicant does not describe the genus of cucumber plants mutated from variety NUN 97080 CUL comprising one or more gene edits, that may confer any number of morphological and/or physiological characteristics to the claimed plant, especially when some of the desired traits listed in the claims are pleiotropic and may profoundly impact in multiple aspects of plant morphology and physiology. Applicant has failed to describe said genus. There is no disclosure of the target gene and how mutating said target gene changes the base genome or the morphological and physiological characteristics of cucumber variety NUN 97080 CUL. The mutated plant may have morphological and physiological characteristics that significantly differ from those of cucumber variety NUN 97080 CUL. Accordingly, the claimed mutated cucumber plant lacks adequate written description.
See Vas-Cath Inc. v. Mahurkar 1991 (CA FC) 19 USPQ2d 1111, 1115, which teaches that the purpose of the written description is for the purpose of warning an innocent purchaser, or other person using a machine, of his infringement of the patent; and at the same time, of taking from the inventor the means of practicing upon the credulity or the fears of other persons, by pretending that his invention is more than what it really is, or different from its ostensible objects, that the patentee is required to distinguish his invention in his specification.
Claim 24 is thus a “reach through” claim in which the Applicant has described a starting material and at least one method step, but has not described the resulting product; and wherein the genus of products that can be produced by the recited method steps and materials is so large that one of skill in the art is not able to envision the members of the genus. (See Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 920-23, 69 USPQ2d 1886, 1890-93 (Fed. Cir. 2004)). Accordingly, the specification fails to provide adequate written description to support the genus of plants produced by introducing any number of transgenes into the claimed cucumber variety NUN 97080 CUL.
Claim Rejections - 35 USC § 103
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 24 is rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Swinkels, R. (US Pub. No. 20210137044 (B)).
As stated in the written description rejection above, the claimed plant lacks adequate written description. The claimed plant is not required to retain all the morphological and physiological characteristics of cucumber variety NUN 97080 CUL in addition to the desired trait.
The prior art teaches cucumber variety NUN 09103 CUL which shares at least 38 characteristics with Applicant’s cucumber variety NUN 97080 CUL, including predominant culture, plant habit, indeterminate growth type, plant sex, flower color, stem form, leaf length, leaf width, petiole length, fruit skin color, fruit tapering, stem end cross section of fruit, medial cross section of fruit, blossom end cross section of fruit, skin thickness of fruit, skin ribs of fruit, skin luster of fruit, spine quality of fruit, total length of first 15 internodes, number of female flowers per node, shape of apex of terminal lobe of leaf, undulation of leaf margin color of vestiture, parthenocarpy presence, shape of calyx end of fruit, absence of fruit sutures, presence of fruit creasing, type of vestiture, absence of fruit warts and absence of fruit dots (Tables A-C).
Accordingly, the claimed invention is anticipated by, or in the alternative, is obvious in view of the prior art. See In re Thorpe, 227 USPQ 964, 966 (Fed. Cir. 1985), which teaches that a product-by-process claim may be properly rejected over prior art teaching the same product produced by a different process, if the process of making the product fails to distinguish the two products. Since the Patent Office does not have the facilities to examine and compare the plant of Applicant’s with that of the prior art, the burden of proof is upon the Applicant to show an unobvious distinction between the claimed plant and the plant of the prior art. See In re Best, 562F.2d 1252, 195 USPQ 430 (CCPA 1977).
Conclusion
No claims are allowed.
Claims 1-23 are deemed provisionally free of the prior art, given the failure of the prior art to teach or suggesting a cucumber cultivar having all of the morphological and physiological characteristics of the claimed variety. It should be noted that this statement is based only on a comparison of the morphological and physiological characteristics of the description against the prior art. This is statement is provisional because Applicant has not provided any information regarding the parental lineage or breeding methodology used to produce the claimed variety. Without this information, a meaningful comparison of the genetic and phenotypic basis that would distinguish the claimed variety from prior art plants cannot be made. Thus, this statement will remain provisional until the necessary information regarding the parental lineage or breeding methodology above are made to the description, and a complete search of the prior art can be completed.
The closest prior art is Shetty (US 10638696 B1, 2020) which teaches Cucumber Hybrid SVCS0927. The prior art cultivar shares many physiological and physiological characteristics with the instantly claimed variety. However, the prior art variety differs from the instantly claimed in at least the disease resistance spectrum, genetic makeup, and breeding history.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WEIHUA FAN whose telephone number is (571)270-0398. The examiner can normally be reached Monday-Friday, 9-5.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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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WEIHUA . FAN
Primary Examiner
Art Unit 1663
/WEIHUA FAN/Primary Examiner, Art Unit 1663