Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
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
Claims 1-20 as filed on 20 August 2024 are examined herein.
Examiner’s Notes
Citations to Applicant’s specification are abbreviated herein “Spec.”
watermelon variety E26C00199.
Examination of the patent application relies on the values presented in the table beginning on page 14 for the claimed variety.
In Fehr (1987) (“Backcross Method” in Principles of Cultivar Development (Macmillan Pub. Co. (New York)) pp. 360-76), the backcross method is described as restoring 75% of the recurrent parent genome after the first backcross and restoring 87.5% of the recurrent parent genome after the second backcross (see Fig. 28-1, p. 362).
Copending Applications
Applicant should bring to the attention of the Examiner, or other Office officials involved with the examination of a particular application, information within their knowledge as to other copending United States applications, which are "material to patentability" of the application in question. MPEP 2001.06(b). See Dayco Products Inc. v. Total Containment Inc., 66 USPQ2d 1801 (CA FC 2003).
Information that is considered material to patentability includes for example, the following.
(a) The plants utilized in the breeding programs that arrived at the ancestral varieties crossed to produce the instant cultivar and their genetic relationship (e.g. grandparent lines).
(b) any progeny, siblings, half-siblings, or other closely genetically related plants that are either co-pending applications or previously published or publicly disclosed.
(c) 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.
(d) 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,
(e) Any alternative designations, experimental names, tradenames, etc. for the instant plant, parent plants, and grandparent plants should be disclosed (e.g. synonyms).
Color Drawings
Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted.
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
A petition was made and granted in a decision on 17 October 2024.
Specification
The disclosure is objected to because of the following informality. In paragraph 0093 regarding the deposit, there is “[DATE] as a placeholder for the deposit. The paragraph also apparently uses “X1” as a placeholder for the accession number.
Appropriate correction is required.
Claim Objections
Claims 1, 9, 18, and 20 are objected to because of the following informalities.
The listed claims apparently use “X1” as a placeholder for the deposit.
Appropriate correction is requested.
35 USC § 112(b)-Based Claim Rejections
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 1-20 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.
Claims 1-20 are rejected because they either recite the limitation E26C00199 or their base claims do, in reference to watermelon plants.
Until the deposit is perfected, the meaning of these limitations is uncertain and creates ambiguity in the claims and thus renders the claims indefinite. The terms are not well known and generally accepted in the art, and the use of this terminology does not carry art-recognized limitations defining the specific characteristics or essential characteristics that are associated with these denominations. In addition, the names appear to be arbitrary, and the specific characteristics associated therewith could be modified, as there is no written description of a watermelon plant that encompasses all of its traits except by deposit. Thus the terms in question lack a general art-accepted meaning and Applicant does not explicitly define, and cannot do so without a deposit, the terms in the specification.
Furthermore, the meaning of this term could arbitrarily change to designate something different during the lifetime of a patent.
Thus, an artisan's ability to determine the metes and bounds of the claim would be impaired. See In re Hammack, 427 F.2d 1378, 1382; 166 USPQ 204, 208 (CCPA 1970).
Additionally, several claims use “X1” as an apparent placeholder for the deposit’s accession number. Other than that potential meaning, “X1” is an indefinite limitation. Replacing it with the accession number would be definite.
Claims 7, 10, 18 are additionally rejected because they recite the limitation “essentially all” relative to “the morphological and physiological characteristics of a watermelon plant.” The limitation "essentially all" is a relative term. Neither the specification nor the claim provides any guidance to what characteristics, or what number of characteristics, are required to fall within the scope of the claims.
Applicant provides a definition for “Essentially all the physiological and morphological characteristics” in paragraph 0046, but that paragraph is specifically directed to, for example, a gene conversion. In claim 10, for example, it is indefinite the scope of the limitation.
Dependent claims are included in these rejections because none provide limitations obviating this rejection.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of 35 U.S.C. 112(a):
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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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.
The Enablement Requirement of 35 USC 112(a) (Deposit)
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 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.
The invention requires plants asserted by Applicant to be the watermelon variety E26C00199.
Since this plant is essential to the claimed invention it must be obtainable by a repeatable method set forth in the specification or otherwise be readily available to the public. If the plant is not so obtainable or available, the requirements of 35 USC § 112 may be satisfied by a deposit of the seeds. A deposit of 625 seeds of each of the parents is considered sufficient to ensure public availability of the variety.
The specification does not disclose a repeatable process to obtain the plant and thus it is not apparent if the plant is readily available to the public with respect to this application. The specification does not teach such a process. Therefore Applicant must deposit seeds to comply with 35 USC 112(a).
The deposits must be accepted under the Budapest Treaty or the results of a viability test must be provided.
Applicant states that a deposit was made (para. 0093) but since no date is given, the accession number “X1” appears to be a placeholder. Thus the statement in the specification is interpreted to be prophetic.
Further, a statement, affidavit or declaration by Applicant, or a statement by an attorney of record over his or her signature and registration number, or someone empowered to make such a statement, stating that the instant invention will be irrevocably and without restriction released to the public upon the issuance of a patent, is required to satisfy the deposit requirement.
Dependent claims are included in this rejection because none provide limitations obviating this rejection.
Written Description Requirement regarding the Specification
Claims 1-20 is/are rejected under 35 U.S.C 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph / objected to, as failing to comply with the written description requirement in view of the following analysis of the specification.
The claims contain 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; or adequately described the claimed invention.
35 USC 112 (a) states that “The specification shall contain a written description of the invention.” In evaluating the written description requirement relative to the specification,, 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 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, E26C00199.
Below is a consideration of what might constitute an adequate written description for a new variety. In evaluating this question of fact, consideration is given to the corresponding art in the public domain. Reviewing the art leads to a reasonable conclusion that generally the minimum requirements for an adequate description of a new plant line is a trait table of phenotypes and genetic information. The breeding history usually provides the genetic information. In reviewing the instant specification there is a phenotypic description in a table of phenotypes beginning at paragraph 0059 through paragraph 0071.
There is no breeding history provided. Developing the claimed plant is generally discussed in paragraph 0023. Three patents are cited in paragraph 0082 as sources for single gene traits but they issued in 1998 or 1999 and all are drawn to maize plants.
Backcrossing is discussed in paragraph 0080
Because the specification has only a minimal breeding history, it is not adequate to fully describe breeding history to illustrate the underlying genetics. Thus Applicant fails to fulfil the requirement of 35 USC 112(a) to provide a written description of the claimed invention in the specification.
A reasonable basis for challenging the adequacy of written description is informed by a review of the following:
The MPEP requires:
he 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))
This requirement is also part of the holding in the Enzo v. Gen-Probe decision.
Furthermore, the Guidelines state that "'[o]nce the patent issues, the description must be sufficient to aid in the resolution of questions of infringement.'" Guidelines at 1107-08 n. 6 (quoting Deposit of Biological Materials for Patent Purposes, Final Rule, 54 Fed. Reg. 34,864, 34880 (Aug. 22, 1989) (codified at 37 C.F.R. pt. 800)).
Enzo Biochem, Inc. v. Gen-Probe Inc., 285 F.3d 1013, 1022, 62 U.S.P.Q.2d 1289, 1295 (Fed. Cir. 2002).
Specifically, in claim 1, applicant claims a new watermelon variety, E26C00199.
. Aside from the deposit, this watermelon variety is defined by both its traits as set forth in the table beginning on page 14 and and by its genetics. A reasonable brief description of its genetics is its breeding history since exhaustive documentation of marker profiles is not found in the art.
In the instant application however, the specification does not provide any description of the breeding history or any other form of the underlying genetics.
Applicant discusses how to use genetic markers (e.g. para. 0075), but other than what is inherent in the deposited seeds, Applicant provides no information regarding the genetics of the deposited seeds.
See Vas-Gath Inc. v. Mahurkar, which teaches that one "purpose of the written description is for the purpose of warning an innocent purchaser, or other person using a machine, of his [or her] 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.” Vas-Gath Inc. v. Mahurkar, 935 F.2d 1555, 1561, 19 U.S.P.Q.2d 1111, 1115 (Fed. Cir. 1991 ).
None of the traits recited in the phenotypic table are unique to the claimed variety. For example, many other watermelon plants have a medium green fruit and/or sharp stripes. (p. 15).
The combination of the phenotypic traits may provide a fingerprint that may be unique to the claimed watermelon variety, or may not.
However a watermelon plant is not produced by selecting individual traits, it is produced by breeding. Thus, in part to protect an unintentional infringer, the breeding history should be provided as a summary of the genetics behind the invention.
Further, availability of the breeding history will expedite a full and through examination of the pending claims
To illustrate this point further, the breeding history features prominently in a recent decision by the Office’s Appeals Board.
In the McGowen decision, after analyzing the breeding history (p. 7 (btm)-8), the Board found the claimed plants to be obvious (p. 10). Ex Parte McGowen (PTAB 2020) (decision in appl. ser. no. 14/996,093). The decision provided extensive discussion of the traits. (para 5-8 & 12 pp. 4-5) These differences were cited by the applicant when comparing the prior art and the new plant variety. But the trait tables insufficient to overcome the finding of obviousness. See, for example, McGowen, paras. 6 & 8 (pp. 4-5). The decision turned on the breeding history. (pp. 8 & 17). Because the breeding history was available, the phenotypic 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.
Thus the breeding history could prove to be extremely useful in the resolution of patent infringement by providing information necessary to determine whether differences in plants where genetic differences, differences caused by the environment, or differences within the normal expected variation within a variety.
For example, the art teaches that intracultivar heterogeneity exists in crop species. Haun et al. teaches that the assumption that elite cultivars are composed of homogenous genetic pools is false. For example, see Haun et al. (2011) Plant Physiol 155:645-55 (p. 645 left col.).
Segregation, recombination, DNA transposition, epigenetic processes, and spontaneous mutations are some of the reasons elite cultivar populations maintain some degree of plant-to-plant variation. E.g.,, Id., 645 (rt. Col. & 646 (lt. col.).
In addition to genetic variation, environmental variation may induce phenotypic variation within a cultivar. See for example, the teachings of Großkinsky et al. regarding “phenome.” Großkinsky et al. (2015) J Exp Bot 66(18):5429–40 (p. 5430 (lt. col. 1st full para. & rt. col. the full para.)).
It is also generally accepted that the environment can effect watermelon traits. See, for example, Dia et al. (2016) Crop Sci 56:1645-61 (1st page); and Dia et al., Horticult Res (2016) 3:16066 (title).
In view of this variability, the breeding history is essential and is the least burdensome way to Applicant to provide genetic information needed by the Office and the public to adequately describe a newly developed plant.
An application that does not clearly describe the breeding history does not provide an adequate written description of the invention and impairs a factual determination of the uniqueness of the claimed line.
[T]he hallmark of written description is disclosure. Thus, "possession as shown in the disclosure" is a more complete formulation. Yet whatever the specific articulation, the test requires an objective inquiry into the four corners of the specification from the perspective of a person of ordinary skill in the art.”
Ariad Pharmaceuticals, Inc. V. Eli Lilly & Co., 598 F.3d 1336 (Fed. Cir. 2010) (en banc),
In particular, “possession as shown in the disclosure" and “the four corners of the specification.” Clearly the Ariad decision supports the rejection.
To overcome this rejection, Applicant should amend the specification/drawings to provide the breeding history used to develop the claimed 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 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 aware of their duty to disclose information material to patentability (see e.g. C.F.R. § 1.56 and MPEP § 2001). 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 variety).
This information can be submitted in an IDS with a notation of the relevancy to the instant application. Or If necessary, this information may be submitted as described in MPEP § 724 (e.g., trade secret, proprietary, and Protective Order).
Written Description Requirement regarding the Claims
Claims 10, and 11-18 are rejected under the following analysis. Claim 10 is drawn to watermelon plant “all, or essentially all, the physiological and morphological characteristics of the watermelon plant of claim 2.”
Claims 1 and 2 reference the deposit but claim10 does not. Therefore it is reasonable to interpret as having a different scope.
It reads on any plant that resembles the plant of claim 2 from any starting materials and any methods of breeding and genetic transformation that produces plants having “essentially all” of the physiological and morphological characteristics of the plant of claim 1, the variety E26C00199.
Further, the specification fails to provide adequate support for the breeding steps of how the line E26C00199 was produced.
Because a vast number of other starting plants and methods exist which may be able to produce watermelon plants having the characteristics of the plant claimed in claim 2, one of ordinary skill in the art would not have recognized that Applicant was in possession of the claimed genus.
Claim 9 reads on a plant produced from the tissue culture of claim 7.
Somaclonal variation is generally accepted to occur during regenerating plants from tissue culture. Although the tissue culture of claim 7 is described by the to-be-deposited seeds, somaclonal variation of a plant obtained from tissue culture increases the size of the genus encompassed by claim. See, e.g., Bairu et al. (2011) Plant Growth Regul 63:147-73. Claim 9 does not require all of the morphological and physiological characteristics of a plant grown deposited seeds, only “or essentially all.”
These claims are "reach through" claims in which the Applicant has potentially described a starting material, the deposited seeds, but also encompasses further changes, however, they have not described the resulting product, and the genus of products that can be produced by the recited starting materials is so large that one of skill in the art is not able to envision the members of the genus. See e.g. Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 920-23, 69 USPQ2d 1886, 1890-93 (Fed. Cir. 2004).
See also Vas-Gath Inc. v. Mahurkar, 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 [or her] 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.” Vas-Gath Inc. v. Mahurkar, 935 F.2d 1555, 1561, 19 U.S.P.Q.2d 1111, 1115 (Fed. Cir. 1991 ). Therefore, in the instant application, the disclosure of a single watermelon plant by deposit (to be perfected), does not provide adequate written description for the claimed genus of plants. The specification fails to describe the fully array of plants comprising the genus of transgenes, heritable traits and/or locus conversions encompassed by the claims. The specification fails to provide an adequate written description to support the breadth of the claims, Applicant has not demonstrated possession to one of skill in the art of the instant invention as broadly as claimed at the time of filing.
In the instant application, a practitioner would not be able to envision the claimed genera and thus be able determine if any particular watermelon plant is infringing the instant claims., Therefore, the public has not been put on notice with a sufficient description of the claimed invention.
Dependent claims are included in this rejection because none provide further limitations obviating this rejection.
Allowable Subject Matter
The phenotypes are distinguishable from other watermelon plants in the patent art. For example, the watermelon line 54WA004 in U.S. Patent No. 9,591,817 B1 (Brusca). Both have flat cotyledons; the instant is triploid and the Patent teaches triploid. However, for example, though, they have different fruit sizes.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RUSSELL T BOGGS whose telephone number is (571)272-2805. The examiner can normally be reached Monday - Friday, 0800 to 1830 Mtn.
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/RUSSELL T BOGGS/Examiner, Art Unit 1663
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