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 .
Claim Status
Claims 1-14 are pending and examined on the merits.
Priority
Acknowledgment is made of applicant's claim for foreign priority (See Oath filed 22 August 2025) based on an application filed in Japan on 26 August 2024. It is noted, however, that applicant has not filed a certified copy of the JP2024-144242 application as required by 37 CFR 1.55.
Title
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: LETTUCE LINE TEXLE213131
Specification
The disclosure is objected to because of the following informalities:
The specification fails to recite breeding history (see lack of written description rejection below).
Item (4) on page 10 of the specification recites, “the plant diameter is “”. It appears that they failed to fill in what was intended to be between the quotation marks.
Appropriate correction is required.
Applicant is reminded of The Duty of Candor and Good Faith. 37 C.F.R. 1.56.
Claim Objections
Claim 8 is objected to because of the following informalities: The claim recites “as the following characteristics (1), (2), and (14)…” This numbering appears to be arbitrary and unnecessary. Moreover, the numbering of the traits in the specification is not consistent. For example, Tables 1-2 list seed color as trait (1), whereas line 19 of page 10 states that it is trait (3). This inconsistency is confusing. The numbering could be removed from claim 8, and the claim would actually become clearer. Appropriate correction is required.
Lack of Written Description – Breeding History
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.
Claims 1-14 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.
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 line (TEXLE213131). So, the examiner will evaluate what is an adequate written description for a new lettuce line. 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 line has a trait descriptions 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, the provided breeding history in the specification in paragraph 167 is generic. There are no names of the parental varieties disclosed, nor were the specific breeding steps used in development of the instantly claimed line. Because the specification lacks a specific breeding history and that breeding history is part of the minimum description of a plant line 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 line.
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, the Specification fails to provide any breeding history. Moreover, the claims indicate Applicant intends to deposit seeds representative of the claimed cultivar. Thus, the claims are not directed to the deposited seeds or plants grown therefrom. The claims are directed to a genus of lettuce plants 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.
Lack of Written Description
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.
Claims 3, 5, 6, and 8 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 3 is drawn to lettuce plants having “essentially all physiological and morphological characteristics of lettuce line TEXLE213131.” Lines 12-16 of page 10 of the specification states that for a lettuce plant to be considered as having all the physiological and morphological characteristics of lettuce line TEXLE213131, it only needs to possess the 14 qualitative characteristics listed on page 10 (see screen capture below).
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This means that plants sharing little genetic and phenotypic characteristics are included in the scope of the claims. Fourteen characteristics is quite small in the context of all possible physiological and morphological characteristics of a lettuce line
The instant disclosure describes a few characteristics and traits of TEXLE213131 (Tables 1-2).
These descriptions are insufficient, because there is little limit on how dissimilar the resultant plants are from the deposited line, given that fourteen traits is relatively few characteristics of all possible characteristics of a line lettuce.
Given the broad scope of the claimed genus one of skill in the art would not have recognized that Applicant was in possession of the claimed genus at the time of filing.
Claim 5 is drawn to lettuce plants regenerated from tissue culture of lettuce line TEXLE213131. Tissue culture is known to induce somaclonal variation in plants.
There is no limit in the claim as to how dissimilar the regenerated plant can be from lettuce line TEXLE213131.
The instant disclosure describes a few characteristics and traits of TEXLE213131 (Tables 1-2).
These descriptions are insufficient, because there is not any limit on how dissimilar the regenerated plants are from the deposited line.
Given the broad scope of the claimed genus one of skill in the art would not have recognized that Applicant was in possession of the claimed genus at the time of filing.
Claim 6 is drawn to lettuce plants produced by processes that introduced at least one mutation in at least one target gene of lettuce line TEXLE213131 without any upper limit to the number of mutations introduced to lettuce line TEXLE213131.
This means that plants sharing little genetic and phenotypic characteristics are included in the scope of the claims.
The instant disclosure describes a few characteristics and traits of TEXLE213131 (Tables 1-2).
These descriptions are insufficient, because there is not any limit on how dissimilar the resultant plants are from the deposited line.
Given the broad scope of the claimed genus one of skill in the art would not have recognized that Applicant was in possession of the claimed genus at the time of filing.
Claim 8 is drawn to progeny of lettuce line TEXLE213131, without specifying the generation, wherein the progeny line includes at least 50% of alleles of a lettuce line TEXLE213131 and is slightly late to bolt, is highly resistant to Fol Race 1, and is resistant to Fol Yuma isolate.
A progeny plant sharing 50% of the alleles as an inbred line is a quite broader scope than an F1 progeny of an inbred plant. This is the case, because if a plant has the same alleles as the inbred parent for both copies of a locus, that can be considered twice in factoring in the percentage shared. This means that a plant being homozygous for the inbred parent allele at as little as 25% of the loci is within the scope of the claim. Which 25% of loci is not specified by the claim.
The instant disclosure describes a few characteristics and traits of TEXLE213131 (Tables 1-2).
These descriptions are insufficient, because there is not any limit on how dissimilar the resultant plants are from the deposited line.
Given the broad scope of the claimed genus one of skill in the art would not have recognized that Applicant was in possession of the claimed genus at the time of filing.
Deposit Rejection
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.
Claims 1-14 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 claims contain 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 and/or plant claimed 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, or seed of the claimed plant 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 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 indicating that all restrictions will be irrevocably be removed upon issuance of a patent, the ATCC Accession No. and evidence of deposit to overcome this rejection.
Conclusion
A search of the prior art cannot be completed without knowledge of the breeding history of the instantly claimed line. Thus, patentability also cannot be assessed without knowledge of the breeding history.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW R KEOGH whose telephone number is (571)272-2960. The examiner can normally be reached on M-Th 7-4:30, half day on Fridays.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amjad 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.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MATTHEW R KEOGH/
Primary Examiner, Art Unit 1663
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