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 .
Status of Claims
Claims 1-24 as filed on 05/23/2024 are pending and are examined in this Office action.
Information Disclosure Statement
Initialed and dated copy of Applicant’s information disclosure statement (IDS) filed on 07/12/2024 is attached to the instant Office Action. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The abstract of the disclosure is objected to because it is not clearly specified that watermelon variety NUN 12201 WMW is a hybrid. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
The following title is suggested: Watermelon Hybrid Variety NUN 12201 WMW.
The disclosure is objected to because of the following informalities:
It is noted that the paragraph [0002] of the specification does not recite “watermelon variety NUN 12201 WMW” as a hybrid, whereas breeding information at paragraph [0192] recites that it is “hybrid NUN 12201 WMW”. There is an inconsistency in the specification as to how NUN 12201 is described since most of the specification does not reference that it is a hybrid. Paragraph [0002] is one example, but most of the paragraphs before [0192] make it unclear if watermelon variety NUN 12201 WMW is a hybrid or an inbred.
Appropriate correction is required.
Claim Objections
Claims 16 and 17 are objected to because of the following informalities:
In claim 16, it is suggested to insert the recitation ---,wherein a representative sample of seed of watermelon variety NUN 12201 WMW has been deposited under Accession Number NCIMB 44147--- at the end of the claim for clarity of the claimed subject matter.
In claim 16, it is suggested to replace “the” before “plant part” in line 1 with ---a--- for proper antecedence of the recitation of “the plant part” in line 2.
In claim 17, line 2, the recitation “plant part” lacks antecedence because claim 1, upon which claim 17 depends, does not recite “plant part”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Indefiniteness
Claims 1-24 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The metes and bounds of “plant” are unclear. Paragraph [0052] states “”Plant” includes the whole plant or any part or derivatives thereof, preferably having the same genetic makeup as the plant from which it is obtained.” This is not a definition for “plant”, because “includes” encompasses other undisclosed embodiments. It is unclear what is retained in the derivatives. It is unclear what genetic makeup is encompassed by a plant of watermelon variety NUN 12201 WMW. Moreover, the claims do not reflect the included embodiments of parts, derivatives and different genetic makeup as set forth in paragraph [0052]. For examination purpose, the Office interprets “plant” by its ordinary meaning as understood by those skilled in the art to be a whole plant. Otherwise, rejections under 35 USC 101, 112(a) and 102 would apply. This interpretation does not relieve Applicant of the duty to amend the claims to address the cited deficiency.
Written Description
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 1-24 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 “The specification shall contain a written description of the invention” (emphasis added). 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 watermelon variety (NUN 12201 WMW). So, the examiner will evaluate what is an adequate written description for a new watermelon variety. In reviewing this question of fact, the examiner analyzes how plant varieties are evaluated in the public domain. The review concludes that generally the minimum requirements for an adequate description of a new plant variety are a trait table and genetic information (via a breeding history). In reviewing Applicant’s specification, there is a phenotypic description of NUN 12201 WMW in Tables 1-3. However, there is no accompanying breeding history in the specification for the claimed variety. Because the specification lacks a breeding history and that breeding history is part of the minimum description of a plant variety, 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 supported 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 in Ex Parte C and Ex Parte McGowen, a trait table is insufficient to differentiate varieties by itself.
It has been long established that intraline heterogeneity exists in crop species. Haun et al. (Plant Physiology, Feb. 2011, Vol. 155, pp. 645-655 (Y)) teaches that the assumption that elite lines 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 line 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 line. (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 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 Applicant’s disclosure a description of the invention defined by the claims. (See MPEP 2163.04). Importantly, it should be noted that the citations above are not referenced for legal authority. The legal authority relied 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 for the adequate description of a plant variety.
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 variations of a variety. 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 yet to be patented. Because the instant specification lacks a complete breeding history, the public will not be able to fully resolve questions of infringement. Since the breeding history, including the parents of the claimed line, 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. An adequate written description is essential to preclude the issuance of a patent that would otherwise issue due to Applicant’s omission of critical information from the Specification.
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 variety 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 varieties, especially publicly disclosed or patented variety 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 variety of a publicly disclosed variety, Applicant should provide the breeding history of the parent variety 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. 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).
In the instant application, the Specification does not disclose the breeding history for the claimed variety. In paragraph [0192], the Specification states that hybrid NUN 12201 WMW was developed from a male and female proprietary inbred line of Nunhems. However, there is no disclosure of the names of the parent proprietary lines, whether they are known by other names and their public availability. Thus, the breeding history for the claimed line as disclosed in the Specification is incomplete.
Paragraph [0002] states that phenotypic variants of variety NUN 12201 WMW are encompassed by Applicant’s invention. Paragraph [0052] states that “plant” includes the whole plant or any part or derivatives thereof, preferably having the same genetic makeup as the plant from which it is obtained. Paragraph [0143] states that morphological and/or physiological characteristics may vary with variation in the environment. Paragraph [0146] states that variants which differ from watermelon variety NUN 12201 WMW in one, two, or three of the characteristics mentioned in Tables 1-3 are encompassed. Thus, the claims are directed to a genus of watermelon plants and seeds that are genotypically and phenotypically different from the deposit, and have different traits from those disclosed in the specification. 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. The complete breeding history for producing the claimed line in the Specification is deemed material for patentability.
Regarding claim 4, Applicant broadly describes “plant part” as comprising any part of a plant, such as a plant organ (e.g., harvested or non-harvested fruits), a plant cell, a plant protoplast, a plant cell tissue culture or a tissue culture from which a whole plant can be regenerated, a plant cell that is intact in a plant, a clone, a micropropagation, plant callus, a plant cell clump, a plant transplant, a vegetative propagation, a seedling, a fruit, a harvested fruit, a part of a fruit, a leaf, a part of a leaf, a pollen, an ovule, an embryo, a petiole, a shoot or a part thereof, a stem or a part thereof, a root or a part thereof, a root tip, a cutting, a seed, a part of a seed, a hypocotyl, a cotyledon, a scion, a graft, a stock, a rootstock, a pistil, an anther, or a flower or part thereof. Seed can be mature or immature. Pollen or ovules may be viable or non-viable. Also, any developmental stage is included, such as seedlings, cuttings prior or after rooting, mature plants or leaves (pages 9-10, paragraph 0053). The claimed “part thereof” of a plant encompasses F1 progeny plant material including an F1 seed and F1 embryo present on the plant. Variety NUN 12201 WMW is a hybrid [0192], whereby its genome is heterologous at every locus. When NUN 12201 WMW 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 NUN 12201 WMW 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 progeny embryo and seed. Accordingly, the claimed “part thereof” of the plant lacks adequate 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 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.
Claim 24 lacks adequate written description for the following reasons. It is unpredictable what morphological and physiological characteristics of watermelon variety NUN 12201 WMW are retained, altered, or deleted after the mutating step in claim 23. The target gene and how it is edited are not disclosed. Moreover, the gene conferring the trait is not simply being added to the genome of NUN 12201 WMW but alters the base genome. Accordingly, the claimed mutated watermelon plant lacks adequate written description. It is suggested that claim 24 recites that the claimed watermelon plant has the desired trait and all the morphological and physiological characteristics of watermelon variety NUN 12201 WMW.
Summary
No claim is allowed.
The closest prior art, Sirizzotti (Sirizzotti et al., Pub. No.: US 2022/0110281 A1, Pub. Date: 04/14/2022) teaches a watermelon variety designated NUN 11801 WMW which shares some of the same traits (e.g., fruit type, ploidy, plant sex form) with the instantly claimed watermelon variety NUN 12201 WMW, however, it differs at least in stem shape, mature fruit shape, and skin color pattern.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINA MEADOWS whose telephone number is (703)756-1430. The examiner can normally be reached Monday - Friday 9:00 am - 5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amjad 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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CHRISTINA MEADOWS
Examiner
Art Unit 1663
/CHRISTINA L MEADOWS/ Examiner, Art Unit 1663
/Amjad Abraham/ SPE, Art Unit 1663