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
1. Claims 1-34 are pending and are examined on merits in the present Office action.
Information Disclosure Statement
2. Initialed and dated copy of Applicant’s IDS form 1449 filed in the paper of May 7, 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
3. The disclosure is objected to because of the following informalities:
At paragraph [0090], last line. The word “States” is incorrectly spelled as “Staes”.
Appropriate correction is required.
Claim Objections
4. Claims 6, 7, 10, 15, 16, 17 and 32 are objected to because of the following informalities:
In claim 6, it is suggested to insert limitations of claim 7 into claim 6 and cancel claim 7. It is important to note a “a plant part” can read on segregating seed which may not have full genetic complement of the plant of claim 2. The claim should be amended to read as follows: ----A plant part of the lettuce plant of claim 2, wherein the plant part is a head, leaf, pollen, ovule, anther, root, or root tip---. The recitation “cell” in claim 7 be deleted because plant part as recited in claim 7 are made up of cell or cells.
In claim 10, it is suggested to convert the recitation “A single locus converted lettuce plant of the plant of claim 2, wherein said converted lettuce plant comprises a” to ---A converted lettuce plant produced by introducing a single locus conversion into the plant of claim 2, wherein said converted lettuce plant comprises said--- for the clarity of claimed subject matter.
In claim 15, it is suggested to insert limitations of claim 16 into claim 15 and cancel claim 16 for clarity of the claimed subject matter. The claim 15 should be amended to read as follows: ---A plant part of the F1 lettuce plant of claim 14, wherein the plant part is a head, leaf, pollen, ovule, anther, root, or root tip---. The recitation “cell” in claim 16 be deleted because plant part as recited in claim 16 are made up of cell or cells.
In claim 17, the recitation “and” at line 2 of part (a) be deleted because claimed method has additional method steps.
In claim 17, (part b): it is suggested to insert ---from the step (a)--- at the end of part (b) for clarity of the claimed subject matter.
In claim 32, part (a), it is suggested to insert the recitation ---converted--- before “the lettuce” in line 1 for clarity of the claimed subject matter.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(a), deposit
The following is a quotation 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.
5. Claims 1-34 are rejected under 35 U.S.C. 112(a) 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. Since the seed of lettuce cultivar variety Thunderstruck is essential to the claimed invention, it must be obtainable by a reproducible method set forth in the specification or otherwise be readily available to the public. If a seed is not so obtainable or available, a deposit thereof may satisfy the requirements of 35 U.S.C. 112. The specification does not disclose a reproducible process to obtain the exact same seed in each occurrence and it is not apparent if such a seed is readily available to the public. If the deposit of the seed is made under the terms of the Budapest Treaty, then an affidavit or declaration by the Applicant, or a statement by an attorney of record over his or her signature and registration number, stating the seed have been deposited under the Budapest Treaty and that the seed will be irrevocably, and without restriction or condition, released to the public upon the issuance of a patent would satisfy the deposit requirement made herein. A minimum deposit of 625 (25 packets of 25 seeds each) seeds is considered sufficient in the ordinary case to assure availability through the period for which a deposit must be maintained.
If the deposit has not been made under the Budapest Treaty, then in order to certify that the deposit meets the criteria set forth in 37 CFR 1.801-1.809, Applicant may provide assurance of compliance by an affidavit or declaration, or by a statement by an attorney of record over his or her signature and registration number showing that
(a) during the pendency of the application, access to the invention will be afforded to the Commissioner upon request;
(b) all restrictions upon availability to the public will be irrevocably removed upon granting of the patent;
(c) the deposit will be maintained in a public depository for a period of 30 years or 5 years after the last request or for the enforceable life of the patent, whichever is longer;
(d) the viability of the biological material at the time of deposit will be tested (see 37 CFR 1.807); and
(e) the deposit will be replaced if it should ever become unviable.
Applicant has NOT indicated that Applicant intends to deposit the seeds at the ATCC in accordance with 37 CFR 1.801-1.809. Accordingly, Applicant needs to provide a signed statement indicating compliance with 37 CFR 1.801-1.809, the ATCC Accession No. and evidence of deposit to overcome this rejection. Compliance with this requirement may be held in abeyance until the application is otherwise in condition for an allowance.
In the instant case, it is noted that that evidence of seed deposit from NCMA is missing in the records. A copy of original receipt from NCMA must be provided to overcome this rejection.
Claim Rejections - 35 USC § 112 (Written Description)
6. Claims 4, 5, 18 and 19 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.
Claims 4 is broadly drawn to a progeny lettuce plant that is (a) within one breeding cross of the plant of lettuce cultivar Thunderstruck, (b) comprises at least 50% of the alleles of the plant of lettuce cultivar Thunderstruck, and (iii) is characterized by resistance to Tomato Bushy Stunt virus and Bremia lactucae strains BI:16-28 and 30-32EU.
Claim 18 is broadly drawn to a seed produced from the method of claim 17 that is (a) within one breeding cross of the plant of lettuce cultivar Thunderstruck, (b) comprises at least 50% of the alleles of the plant of lettuce cultivar Thunderstruck, and (c) a plant produced by said lettuce seed is characterized by resistance to Tomato Bushy Stunt virus and Bremia lactucae strains BI:16-28 and 30-32EU.
It may be noted that the breadth of claims encompasses a genus having species that may not have even a first full set of chromosomes lacking full complement of alleles. Under this scenario, the breadth of claims encompasses a genus having species lacking unknown number of alleles of the plant of lettuce cultivar Thunderstruck.
The written description requires that the specification clearly convey to those skilled in the art that the Applicant had possession of the claimed subject matter as of the earliest filing date, and such possession must be demonstrated for the entire scope of the claim. Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010).
The only species described is a Lettuce cultivar Thunderstruck plant with specific number of characteristics as described in Table 1 at pages 18-21. The specification does not describe any said progeny plants or plants produced by said lettuce seed of plant of lettuce cultivar Thunderstruck, nor does it disclose representative examples, breeding populations, or genetic characterization to demonstrate possession of broad genus or progeny lettuce plants or seeds as encompassed by the breadth and scope of claims.
Claims are not limited to a specific progeny plant or plants produced from said seed, generation, or genotype but instead encompassed any lettuce plant within one breeding cross that comprises at least 50% of the alleles of the plant of lettuce cultivar Thunderstruck plant and exhibits recited disease resistance. The claims encompasses a large and genetically diverse population of plants, whose members may differ substantially from the disclosed lettuce cultivar Thunderstruck plant.
The Federal Circuit has repeatedly held that disclosure of a single species does not provide written description support for a broad genus absent disclosure of either (i) representative number of species or (ii) structural features common to the members of the genus such that on skill in the art can visualize or recognize the claimed genus. Ariad, 598 F .3d at 1350; Regents of the Univ. of Cal. V. Eli Lilly & Co., 119F.3d 1559, 1568-69 (Fed. Cir. 1997).
Additionally, the claims further defines the progeny plants or plants produced by said seed by functional disease resistance traits. The specification does not disclose how such resistance is predictably inherited or uniformly retained all progeny plants or plants obtained from said seed falling within the scope of these claims.
The Federal Circuit has made clear that functional claiming of a broad genus, without disclosure of a sufficient number of species or a common structural feature correlated with the function, fails the written description requirement. Ariad F .3d at 1350; AbbVie Deutschland GmbH v. Janssen Biotech, Inc., 759 F.3d 1285, 1299-1301 (Fed. Cir. 2014).
It is important to note that art of plant breeding is biologically unpredictable, and progeny plants or plants obtained from said seed which are derived from a single cross can exhibit wide genetic and phenotypic variation. In the absence of disclosure of representative plants or plants obtained from said seed , or genetic determinants of the claimed traits, the specification does not demonstrate possession of the full scope of progeny plants encompassed by claim 4 and seed(s) encompassed by claim 18. See In re Alonso, 545 F.3d 1015, 1021 (Fed. Cir. 2008).
The breadth of claim encompasses progeny plants or seeds with unknown alleles with second set of chromosomes. The breadth of claim encompasses a genus having species with unknown structures(s) whose function cannot be reliably determined.
Thus, Applicant’s broadly claimed genus encompasses species whose structure is unknown and hence their function is either unknown or unpredictable.
The specification fails to describe representative species of Applicant’s broadly claimed genus.
There is no description of the structure required for the recited function, and no description of the necessary and sufficient elements of functional activity of diverse structures encompassed by Applicant’s broadly claimed genus is thus unknown.
One of skill in the art would not recognize that Applicant was in possession of the necessary common attributes or features of the genus in view of the disclosed species. Since the disclosure fails to describe the common attributes that identify members of the genus, and because the genus is highly variant, Lettuce cultivar Thunderstruck is insufficient to describe the claimed genus.
In summary, the specification’s disclosure of a single lettuce variety cultivar Thunderstruck does not reasonably convey to a person of ordinary skill in the art that the inventor possessed all progeny lettuce plants or plants obtained from seeds that are one breeding cross, comprising at least 50% of the alleles of the lettuce variety cultivar Thunderstruck plant, and exhibiting the instantly claimed recited disease resistance.
Accordingly, there is lack of adequate description to inform a skilled artisan that applicant was in possession of the claimed invention at the time of filing. See Written Description guidelines published Federal Register/Vol.66, No. 4/Friday, January 5, 2001/Notices; p. 1099-1111.
Given the claim breadth and lack of guidance as discussed above, the specification does not provide written description of the genus broadly claimed. Accordingly, one skilled in the art would not have recognized Applicants to have been in possession of the claimed invention at the time of filing.
Dependent claims are also rejected because they fail to overcome the deficiency of parent claims.
Claim Rejections - 35 USC § 112(a) (Written Description-lack of Breeding History)
7. Claims 1-34 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
35 USC 112 (a) states that “The specification shall contain a written description of the invention”. In evaluating written description, the threshold question is what is “an adequate written description”. This is question of fact that is evaluated by the factfinder (examiner). MPEP 2163.04 clearly states that “The inquiry into whether the description requirement is met must be determined on a case-by-case basis and is a question of fact. In re Wertheim, 541 F.2d 257, 262, 191 USPQ 90, 96 (CCPA 1976).”
The instant invention is a new lettuce cultivar variety Thunderstruck. So, the examiner will evaluate what is an adequate written description for a new lettuce cultivar variety Thunderstruck. 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 tables 1 and 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 above factual evidence provides a reasonable basis that a breeding history is necessary written description. With this information the examiner has met the initial burden of presenting by a preponderance of evidence why a person of ordinary skill in the art would not recognize in an applicant’s disclosure a description of the invention defined by the claims. (See MPEP 2163.04). Please note, the citations above are not for legal authority, the legal authority relied upon by the examiner is the 35 USC 112(a) statute. The citations are presented to support the finding of fact that a breeding history is necessary to the adequate description of a plant.
Although not directly relied upon for the above written description position, a complete written description additionally helps drive examination and help with infringement verification.
MPEP 2163 (I) states “The written description of the deposited material needs to be as complete as possible because the examination for patentability proceeds solely on the basis of the written description. See, e.g., In re Lundak, 773 F.2d 1216, 227 USPQ 90 (Fed. Cir. 1985); see also 54 Fed. Reg. at 34,880 ("As a general rule, the more information that is provided about a particular deposited biological material, the better the examiner will be able to compare the identity and characteristics of the deposited biological material with the prior art.").”
MPEP 2163(I) states “The description must be sufficient to permit verification that the deposited biological material is in fact that disclosed. Once the patent issues, the description must be sufficient to aid in the resolution of questions of infringement." Id. at 34,880.)” (Quoting the Deposit of Biological Materials for Patent Purposes, Final Rule, 54 Fed. Reg. 34,864 (August 22, 1989) at 34,880).
The breeding history aids in the resolution of patent infringement by providing information necessary to determine whether differences in the plants are genetic differences, differences caused by the environment, or differences within the accepted variation within a variety.
Moreover, a specification devoid of a complete breeding history hampers the public’s ability to resolve infringement analysis with plants already in the prior art as well as plants that have not yet been patented. Because the instant specification lacks the complete breeding history, the public will not be able to fully resolve questions of infringement. Since the breeding history, including the parents, is not known to the public, the public could only rely on the phenotypes of the claimed plants for assessing potential infringement.
Thus, an application that does not clearly describe the breeding history does not provide an adequate written description of the invention.
To overcome this rejection, Applicant must amend the specification/drawing to provide the breeding history used to develop the instant cultivar. When identifying the breeding history, Applicant should identify any and all other potential names for all parental lines utilized in the development of the instant cultivar and all other potential names for the claimed cultivar. If Applicant’s breeding history uses proprietary cultivar names, Applicant should notate in the specification all other names of the proprietary cultivars, especially publicly disclosed or patented cultivar information. If the breeding history encompasses a locus conversion or a backcrossing process, Applicant should clearly indicate the recurrent parent and the donor plant and specifically name the trait or transgenic event that is being donated to the recurrent parent. If one of the parents is a backcross progeny or locus converted line of a publicly disclosed line, Applicant should provide the breeding history of the parent line as well (i.e., grandparents). Applicant should identify the breeding method used, such as single seed descent, bulk method, backcross method, etc., and the filial generation in which the instant plant was chosen. Information pertaining to the homozygosity or heterozygosity of the parents as well as the instant plant should be set forth.
Applicant is reminded that they have a duty to disclose information material to patentability. Applicant should also notate the most similar plants which should include any other plants created using similar breeding history (such as siblings of the instant cultivar). If there any patent applications or patents in which sibs or parents of the instant plant are claimed, the serial numbers and names of the sibs or parents should be disclosed. This information can be submitted in an IDS with a notation of the relevancy to the instant application or as information submitted as described in MPEP 724 (e.g., trade secret, proprietary, and Protective Order).
35 USC 112(a) clearly states “The specification (emphasis added) shall contain a written description of the invention”. In the instant application, Applicant’s attention is drawn to the paragraph [0090] at page 18 of the specification which says:
“Characteristics. Lettuce cultivar Thunderstruck is a dark green Greenleaf (also
known as Batavia) lettuce variety suitable for conventional lettuce production settings.
Thunderstruck performs well in all lettuce growing production slots and areas of the
Coastal California and Desert Southwest of California and Arizona regions. Greenleaf
lettuce variety Thunderstruck is the result of a cross between Greenleaf lettuce
experimental elite advanced lines. Thunderstruck was developed with numerous
subsequent generations of individual plant selections chosen for horticultural traits such
as refined Greenleaf, short core, color, straight midribs, good internal fill, density, and
pliability. Thunderstruck possesses strong resistances for Tomato Bushy Stunt Virus
and all Downy mildew races presently designated in the United States.”
Applicant included no breeding history for lettuce cultivar variety Thunderstruck in the specification. No additional names for all parent(s) involved in creating hybrid lettuce cultivar variety Thunderstruck is disclosed in the specification. This disclosure is insufficient and incomplete because it does not address all the issues set forth above
Thus, the breeding history for the claimed cultivar as disclosed in the Specification is incomplete by just stating “Greenleaf lettuce variety Thunderstruck is the result of a cross between Greenleaf lettuce experimental elite advanced lines.” Moreover, the claims indicate Applicant has deposited seeds representative of the claimed Lettuce cultivar Thunderstruck. It must be noted that there is natural variation in lettuce caused by genetics and environment. Additionally, the specification at paragraph [0084] describes that the “claimed lettuce cultivar variety Thunderstruck” includes any single gene conversions of that cultivar, and said plant has essentially all the morphological and physiological characteristics of the cultivar. Thus, the claims are not directed to the deposited seeds or plants grown therefrom. The claims are directed to a genus of lettuce cultivar and seeds that are genotypically and phenotypically different from the deposit, and have different traits from those disclosed in the specification. Given these differences, the complete breeding history for producing the claimed cultivar, including all names for the parents and for the claimed cultivar, are material for patentability. A specification devoid of a complete breeding history hampers the public’s ability to fully resolve questions of infringement.
Conclusion
8. Claims 1-34 are rejected. The closest prior art, Peng (US Patent NO. US 10, 398,109 B1, Issued September 3, 2019) teaches a lettuce variety designated Glenrio which shares some of the same traits(e.g. susceptible heat dormancy, broad shape of cotyledons, summer maturity days) as the instantly claimed lettuce variety Thunderstruck, however, it differs at least seed color, margin indentation of mature leaf, winter maturity days, including breeding history of two varieties as breeding history of instant variety is unknown.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VINOD KUMAR whose telephone number is (571)272-4445. The examiner can normally be reached at (571)-272-44445.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amjad A. Abraham can be reached on (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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/VINOD KUMAR/ Primary Examiner, Art Unit 1663