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 the Claims
Claims 1-24 are pending.
Claims 1-24 are examined herein.
Information Disclosure Statement
The Information Disclosure Statement filed on 05/08/2024 is in compliance with the provisions
of 37 CFR 1.97 and has been considered in full. A signed copy of the list of references cited is included with this Office Action.
The listing of references in the specification (pgs. 45-46, paragraph 0196) 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 Requirement
This application requires public availability of specific biological material to make and use the claimed invention. A rejection under the appropriate sections of 35 U.S.C. § 112(a) would have been made but for an acceptable deposit of the specific biological material in compliance with the requirements under 37 CFR § 1.801-1.809 was already made. Because viability testing of all deposits is required before they can be considered to meet the requirements of 37 CFR § 1.801-1.809, Applicants are advised to perfect the deposit as early as is possible, and before the payment of the issue fee. Applicant’s section on “Deposit Information” conforms with the requirements of 37 CFR § 1.801-1.809.
The instant specification (pgs. 46-47, paragraphs 0199-0200) included a statement that the deposits were accepted under the terms of the Budapest Treaty. Therefore, no such rejection is made.
Drawings
The drawings are objected to for the following reasons:
37 CFR 1.84 (u)(1) states “View numbers must be preceded by the abbreviation "FIG."”
In the current case, the view number for Figures 1-5 are preceded by the word "Figure" instead
of the abbreviation "FIG.".
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office
action to avoid abandonment of the application. Any amended replacement drawing sheet should
include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is
being amended. The figure or figure number of an amended drawing should not be labeled as
“amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the
replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate
changes made to the brief description of the several views of the drawings for consistency. Additional
replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing
sheet submitted after the filing date of an application must be labeled in the top margin as either
“Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by
the examiner, the applicant will be notified and informed of any required corrective action in the next
Office action. The objection to the drawings will not be held in abeyance.
Specification
The abstract of the disclosure is objected to because of the following:
In the Abstract, the recitation of “new and distinct” is objected to because novelty and distinctiveness have not been established during examination and is presumed upon patent grant. It is suggested this recitation be deleted.
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 disclosure is objected to because of the following informalities:
The title and the beginning of the specification (from paragraph 0002-0123) do not clearly label the instant watermelon variety as a hybrid. The verbiage regarding the variety (for example, if the instant variety is a hybrid or an inbred variety) should be consistent in both the title and throughout the instant specification.
Appropriate correction is required.
Claim Objections
Claims 1-24 are objected to because of the following informalities:
In Claims 1, 7, 8, 10, 12, 17, and 23 the recitation of “…sample of seed…has been deposited” should be amended to recite “…sample of seeds…have been deposited”, because more than one seed is deposited.
In Claim 8, line 3, the recitation of “the plant of” should be deleted because the part thereof cannot have all the physiological and morphological characteristics of the plant of variety NUN 22104 WMW.
In Claim 21, part (d) the term “further” should be inserted before the term “ derived” to distinguish the plant of step (a) from the plant of step (d).
All dependent claims thereof are included in these objections.
Appropriate correction is required.
Claim Interpretation
It is understood by the Office that the term “part” recited in Claims 2, 4-5, 7-8, 12, 16, 17, and 23 encompasses at least one regenerable cell. In Claim 1, the “seed of watermelon variety NUN 22104 WMW” is the seed as represented by the deposit. Additionally, claims directed to a fruit obtained from a plant of NUN 22104 WMW are understood to be the NUN 22104 WMW fruit as described in the Tables within Applicant’s instant disclosure.
Claim Rejections - 35 USC § 112
Indefiniteness
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.
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 the term “plant” recited in Claims 1-18 and 20-24 are unclear. Paragraph [0054] states that the term ”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 22104 WMW. Moreover, the claims do not reflect the included embodiments of parts, derivatives and different genetic makeup as set forth in paragraph [0054]. 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.
All dependent claims thereof are included in the rejection for the same reasons as given above.
In Claim 16, line 1, it is unclear what plant part “the plant part” refers to, because a plant has many plant parts. The recitation of “the plant part” lacks antecedence.
In Claim 16, absent a deposit recitation, the term “NUN 22104 WMW” is not an art-recognized term, because the name does not clearly identify the claimed watermelon variety or seed and does not set forth the metes and bounds of the claimed invention. Since the name of NUN 22104 WMW is not known in the art, the use of said name does not carry art recognized limitation as to the specific characteristics or essential characteristics that are associated with denomination. In addition, the name appears to be arbitrarily assigned and the specific characteristics associated therewith could be modified, as there is no written description of the watermelon plant that encompasses all of its traits. To overcome this aspect of the indefinites rejection Applicant should amend Claims 16 recite, for example, the complete accession number for watermelon variety NUN 22104 WMW.
In Claim 17, “plant part of claim 1” lacks antecedence. Claim 1, from which Claim 17 depends. does not recite “plant part”.
Claim Rejections - 35 USC § 112
Written Description and Enablement
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 U.S.C §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 22104 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 22104 WMW in Tables 1-3. However, there is only a partial breeding history in the specification for the claimed variety, which does not provide actual identifiable information about the parental varieties of the instant hybrid variety (pg. 46, paragraph 0197). Because the specification lacks a full 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 [0197], the Specification states that hybrid NUN 22104 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. Moreover, the claims recite that the deposited seeds are representative of variety NUN 22104 WMW. The claims are not directed to the deposited seeds or plants grown therefrom. Paragraph [0002] states that phenotypic variants of variety NUN 22104 WMW are encompassed by Applicant’s invention. Paragraph [0054] 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 [0148] states that morphological and/or physiological characteristics may vary with variation in the environment. Paragraph [0151] states that variants which differ from watermelon variety NUN 22104 WMW in one, two, or three of the characteristics mentioned in Tables 1 and 2 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. 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. Moreover, Claim 20 in effect would make the public an infringer to genotype the instant variety as a means to distinguish their plant from the instant variety. Given these differences, the complete breeding history for producing the claimed line in the Specification is deemed material for patentability.
Additionally, Claim 24 lacks adequate written description for the following reasons. It is unpredictable what morphological and physiological characteristics of watermelon variety NUN 22104 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 22104 WMW but alters the base genome. Accordingly, the claimed mutated watermelon plant lacks adequate written description. To overcome this aspect of the written description rejection, it is suggested that Applicant amend Claim 24 to recite that the claimed watermelon plant has the desired trait and all the morphological and physiological characteristics of watermelon variety NUN 22104 WMW.
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 enablement requirement. The claim 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).
With regard to Claim 16, watermelon variety NUN 22104 WMW 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.
Closest Prior Art
Claims 1-24 appear to be free of the prior art, given the failure of the prior art to teach or reasonably suggest a watermelon variety having all the phenotypic characteristics of the exemplified watermelon variety listed in Tables 1-3 (pgs. 48-53), or methods of its use. The closest prior art in regard to Claims 1-24 can be found in Guner et al. (US Patent Application 2023/0270069, published 08/31/2023) which teaches watermelon variety WDL0107 having the same maturity (medium), leaf color (RHS 147B), leaf lobes, dorsal surface pubescence, and ventral surface pubescence, and fruit surface as instant watermelon variety NUN 22104 WMW. However, watermelon variety WDL0107 differs from the instant watermelon variety in at least: parental genetics, flower color, fruit shape, rind texture, flesh texture, flesh color, and disease resistances.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KELSEY L. MCWILLIAMS whose telephone number is (703)756-4704. The examiner can normally be reached M-F 08:00-17:30.
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 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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/KELSEY L MCWILLIAMS/Examiner, Art Unit 1663
/Amjad Abraham/SPE, Art Unit 1663