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 1-10, 13-18 and 21-23 are pending and examined. Claims 11, 12, 19, 20 and 24-29 have been cancelled.
Election/Restriction
Applicant’s election without traverse of the species of E01C11866 in the reply filed on 13 March 2026 is acknowledged. Claims 1-10, 13-18 and 21-23 read on the elected species.
Specification
The specification is objected to for failing to state the deposit number and the date of the deposit (¶ 00142).
Appropriate action is advised.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-10, 13-18 and 21-23 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, 10, 17, 18, 21 and 22 recite the limitation ‘E01C11866’ while claims 1, 17 and 18 recite the limitation NCIMB Accession Number “X1”. The metes and bounds of the claim are indefinite because these are not an art-recognized terms that are arbitrary such that one would not know what is or is not encompassed by the claims.
Claims 2-9, 13-16 and 23 are rejected for depending upon a rejected base claim and for failing to remedy the issues of indefiniteness.
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 1-10, 13-18 and 21-23 are rejected under 35 U.S.C. 112(a) as containing 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 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 is not so obtainable or available, a deposit thereof may satisfy the requirements of 35 U.S.C. 112.
The specification teaches that lettuce variety E01C11866 is an inbred cutting variety that has shown uniformity and stability for traits (¶ 0084 and 0085).
However, 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 deposited the seeds at the NCIMB in accordance with 37 CFR 1.801-1.809 by indicating all restrictions upon availability to the public will be irrevocably removed upon granting of the patent.
Applicant has also not indicated an intention to deposit the seeds in accordance with the Budapest Treaty, and by way of affidavit or declaration by the Applicant, or a statement by an attorney of record over his or her signature and registration number, stated that the seed will be irrevocably, and without restriction or condition, released to the public upon the issuance of a patent.
Accordingly, Applicant needs to provide a signed statement indicating compliance with 37 CFR 1.801-1.809, the NCIMB Accession No. and evidence of deposit to overcome this rejection. Alternatively, Applicant may by way of affidavit or declaration by the Applicant, or a statement by an attorney of record over his or her signature and registration number, state that the seed will be irrevocably, and without restriction or condition, released to the public upon the issuance of a patent.
Compliance with this requirement may be held in abeyance until the application is otherwise in condition for an allowance.
Claims 1-10, 13-18 and 21-23 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.
Instant claims 6 and 18 are drawn to a lettuce plant or regenerated lettuce plant having “essentially” all of the physiological and morphological characteristics of a lettuce plant produced from seed designated E01C11866 or from a tissue culture thereof.
Meanwhile, the specification describes that “essentially all” means that the plants share essentially all physiological and morphological characteristics identified herein with respect to a disclosed plant or variety, except, e.g., where applicable, with respect to characteristics derived from a converted gene that differs between the plants as a result backcrossing, mutation, or genetic engineering (¶ 0076).
The written description requirement may be satisfied through sufficient description of a representative number of species by disclosing relevant and identifying characteristics such as structural or other physical and/or chemical properties, by disclosing functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the invention as claimed. See Eli Lilly,119 F.3d at 1568, 43 USPQ2d at 1406.
Here, claims 6 and 18 encompass a vast genus of plants as the specification fails to adequately describe what encompasses essentially all of the physiological and morphological characteristics such that these plants may differ from plants grown from seed of the deposited variety.
Thus, the skilled practitioner would not be of the opinion that Applicant possesses this exhaustive genus of plants as the specification has failed to describe a representative number of species from the genus of lettuce plants or regenerated lettuce plants having “essentially” all of the physiological and morphological characteristics of a lettuce plant produced from seed designated E01C11866 or from a tissue culture thereof.
Regarding the development of instantly claimed lettuce variety E01C11866, 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 (i.e., the examiner). MPEP 2163.04 emphasizes this: “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 claims are directed to seeds of lettuce variety E01C11866, plants produced therefrom and methods of using said plant. In reviewing whether the specification provides an adequate written description for this variety E01C11866 the Examiner analyzes how plant lines are evaluated in the public domain. This review concludes the minimum requirements for an adequate description of a new plant variety is a trait table and genetic information supplied through a breeding history.
The specification provides a phenotypic description of lettuce variety E01C11866 yet fails to provide the breeding history to arrive at said variety (e.g., see Table 1).
Because a 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 I s 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, accessed 05/01/2023).
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 Notes 14 and 30).
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) and Ex Parte McGowen, Board Decision in Application 14/996,093, decided June 15, 2020). 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 alone is insufficient to differentiate varieties. It has been long established that intracultivar heterogeneity exists in crop species. Haun et al (2011, Plant Physiol., 155:645-655) teaches that the assumption that elite cultivars are composed of relatively homogenous genetic pools is false (p. 645, col. 1). 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, col. 2 and p. 646, col. 1). In addition to genetic variation, environmental variation may lead to phenotypic variation within a cultivar (Großkinsky et al, 2015, J. Exp. Bot., 66:5429-5440; p. 5430, col. 1, ¶2, and col. 2, ¶3). 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, as 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 for 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 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.").
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, in this case, all names of both parents, is not known to the public, the public does not have all needed information 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 to provide the breeding history used to develop lettuce variety E01C11866. 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.
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).
Conclusion
No claim is allowed.
The closest prior art appears to be Van Zee (Patent No. US 11,399,477 B2), which teaches lettuce variety NUN 09148 LTL having many of the same characteristics as instantly claimed lettuce variety E01C11866. However, lettuce variety NUN 09148 LTL does not have all of the traits of the instantly claimed variety. Moreover, a comparison of the closest prior art is not possible because the breeding history for lettuce variety E01C11866 has not been provided.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JASON DEVEAU-ROSEN whose telephone number is (571)272-2828. The examiner can normally be reached 7:30am - 4pm.
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, Bratislav Stankovic can be reached at (571)270-0305. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JASON DEVEAU ROSEN/Primary Examiner, Art Unit 1662
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