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 .
Information Disclosure Statement
The applicant does not include an Information Disclosure Statement. The listed and cited reference(s) in the specification, is/are not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Status of claims
Claims 1-19 are pending and examined.
Priority
Instant application 18783046, filed 07/24/2024, claims Priority from Provisional Application 63529533, filed 07/28/2023, which is recognized.
Object to the specification
The specification is objected because blanks are disclosed.
For example, in [0086], lines 3-4, “NCIMB number X1. The seeds deposited with the ATCC on DATE “. The “X1” should be a real deposit number. The “DATE" should be an actual date.
Appropriate corrections are required.
Claim Rejections - 35 USC § 112
Enablement/Lacking perfected Deposit
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 1-19 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.
Claims are drawn to a seed and plant of lettuce ‘Sunberg’, a plant part, tissue culture, method of using the plant, and more.
The of lettuce ‘Sunberg’ appears to be a novel biological material. Since the seed claimed 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 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 repeatable 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.
The examiner noticed that in the specification ([0086]): “A deposit of at least 625 seeds of the lettuce variety 'Sunberg' was made with the National Collection of Industrial, Food and Marine Bacteria Ltd. (NCIMB Ltd), Wellheads Place, Dyce, Aberdeen, AB21 7GB, United Kingdom, and assigned NCIMB Number X1. The seeds deposited with the NCIMB on DATE were obtained from the seed of the variety maintained by Enza Zaden USA, Inc., 7 Harris Place, Salinas, California 93901, United States since prior to the filing date of the application. Access to this deposit will be available during the pendency of this application to persons determined by the Commissioner of Patents and Trademarks to be entitled thereto under 37 C.F.R. § 1.14 and 35 U.S.C. § 122. Upon issuance, the Applicant will make the deposit available to the public consistent with all of the requirements of 37 C.F.R. § 1.801-1.809. This deposit of the lettuce variety 'Sunberg' will be maintained in the NCIMB, which is a public depository, for a period of 30 years, or at least 5 years after the most recent request for a sample of the deposit, or for the effective life of the patent, whichever is longer, and will be replaced if it becomes nonviable during that period. Applicant has no authority to waive any restrictions imposed by law on the transfer of biological material or its transportation in commerce. Applicant does not waive any infringement of rights granted under this patent or under the Plant Variety Protection Act (7 USC 2321 et seq.).”
However, there is no indication as to whether the seeds have actually been deposited under the Budapest Treaty nor an affirmation that the deposit meets all of the requirements of 37 CFR 1.801-1.809, and has been satisfactorily accepted.
Additionally, there is no deposit receipt or any document from NCIMB filed by the applicant. Thus, there is no clear indication that the deposit has actually been made and accepted.
If the deposit has been made under the terms of the Budapest Treaty, then a statement, affidavit or declaration by Applicants, 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 specific strain has been deposited under the Budapest Treaty and that the strain will be irrevocably and without restriction released to the public upon the issuance of a patent, and will be publicly available for the enforceable life of the patent, would satisfy the deposit requirement made herein.
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 C.F.R. 1.801-1.809 and MPEP 2402-2411.05, Applicants may provide assurance of compliance by statement, affidavit or declaration, or by someone empowered to make the same, 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 for the enforceable life of the patent in accordance with 37 CFR § 1.808(a)(2);
(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; and
(d) the viability of the biological material at the time of deposit will be tested (see 37 CFR 1.807).
In addition, the information set forth in 37 CFR 1.809(d) should be added to the specification. See 37 C.F.R. 1.801-1.809 for additional explanation of these requirements. The information should include the statement of “all restrictions on the accessibility be irrevocably removed”.
Indefiniteness
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
6. Claims 1-19 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 pre-AIA the applicant regards as the invention.
Claims (claims 1, 15-16) recite blanks “X1” after NCIMB Accession Number, thus are not complete. According to MPEP 2173, where possible, claims are to be complete in themselves.
In addition, the deposit of the representative seed of the ‘Sunberg’ has not been made and accepted (as analyzed above).
Moreover, the parent lines and breeding history of the ‘Sunberg’ are not disclosed by the applicant. Thus, the genetic background of the ‘Sunberg’ is unknown.
Therefore, ‘Sunberg’ is not an art recognized or accepted term.
Dependent claims do not cure the deficiency.
Appropriate corrections are required.
7. Claims 6-9, 16 are additionally 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 pre-AIA the applicant regards as the invention.
Claims 6 and 16 recites “essentially all of the morphological and physiological characteristics of a lettuce plant produced by growing seed designated as ‘Sunberg’. It is indefinite due to the word “essentially”. One of skill in the art would not know with reasonable certainty which characteristics of lettuce variety Armstrong are required for a plant to be encompassed by the claims.
The specification does not define “essentially” or “essentially all”.
The British Dictionary (via Websters.com) defines “essentially” as “in a fundamental or basic way; in essence” and Websters.com defines “essential” as “absolutely necessary; indispensable".
The specification lists some of the representative morphological and physiological characteristics of ‘Sunberg’ ([0061]-[0072]). It is unclear which characteristics of ‘Sunberg’ are considered "essential", and it is unclear how many of the characteristics would need to be present to satisfy the limitation that “essentially all” of the characteristics are present. It is also unclear how many of the characteristics can be missing or changed to still satisfy the limitation that “essentially all” of the characteristics are present.
One of skill in the art would not know with reasonable certainty how many characteristics can be present, missing, or changed in a plant and the plant still comprise "essentially all" of the characteristics of ‘Sunberg’ as required by the claims. How many traits can be altered and still be considered to have “essentially all” of the morphological and physiological characteristics of the deposited line? How many and what particular traits that are “essential” and must be retained?
For these reasons, the claims are indefinite because one of skill in the art, in light of the specification and prosecution history, would not know with reasonable certainty what the scope of the claimed invention is.
Dependent claims 7-9 do not cure the deficiency, thus, are included.
Lacking written description
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.
8. Claims 1-19 are rejected under 35 U.S.C. 112(a), 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.
9. The rejection is made because the specification fails to disclose the breeding history and parent lines of the instant lettuce ‘Sunberg’.
In the instant application, a full examination cannot be conducted because the applicant failed to provide the parent lines and breeding history for the instantly claimed plant line. The applicant is claiming a seed and a plant of ‘Sunberg’, possibly a new plant. A plant line is defined and described by both its genetics (breeding history particularly the parent line(s)) and its traits. In the instant application, the applicant has only provided a “overview” and a “objective description” of the traits of ‘Sunberg’ ([0059]-[0072], Table 1). However, instant specification does not describe the breeding history, particularly the parent line(s), of the claimed ‘Sunberg’. In another word, the instant application is silent or incomplete as to the breeding history used to produce the claimed plant line.
As a result, instant specification fails to satisfy the written description requirement of 35 U.S. Code § 112(a) because it does not provide a description sufficient to conduct an examination, including search of the prior art, nor does it provide enough description to be sufficient to aid in the resolution of questions of infringement.
10. MPEP 2163 (I) states that “…. a deposit is not a substitute for a written description of the claimed invention. 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.").” and states that “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 criticality of a breeding history in assessing the intellectual property rights of a plant is well recognized in the field of plant breeding. With regard to Plant Patents, MPEP 1605 states that a complete detailed description of a plant includes “the origin or parentage”. Other bodies that grant intellectual property protection for plant varieties require breeding information to evaluate whether protection should be granted to new varieties. A breeding history, including information about parentage and breeding methodology, is part of the requirements of Plant Line Protection (PVP) applications. That information is used to “determine if development is sufficient to consider the line new” (See “Applying for a Plant Line Certificate of Protection” by the USDA reference to Exhibit A). Additionally, 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 (See UPOV EDV Explanatory Notes 14 and 30). While the USPTO, USDA, and UPOV have different laws governing intellectual property rights, all recognize that a breeding history is an essential part of adequate description of the plant sought to be protected.
The breeding history is also necessary to aid 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 accepted variation within a line. Historically, the USPTO has considered breeding history information when determining the patentability of a new plant line (See Ex Parte C (USPQ 2d 1492 (1992) and Ex Parte McGowen- Board Decision in Application 14/996,093). In both of these cases, there were many differences cited by the applicant when comparing the prior art and the new plant line. 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. Moreover, a specification devoid of a 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 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.
11. Furthermore, a breeding history particularly parent lines is essential to search siblings of instant plant to determine if there is/are any double patenting(s).
As seen above in Ex Parte C and Ex Parte McGowan, a trait table (for example, Table 2 in [0060]) is insufficient to differentiate varieties by itself. It has been long established that intracultivar heterogeneity exists in crop species.
12. In the art, the physiological and morphological characteristics of plants depend on the genetical structure.
For example, Haun et al (The Composition and Origins of Genomic Variation among Individuals of the Soybean Reference Cultivar Williams. Plant Physiology. P645-655, 2011) teach that the assumption that elite cultivars are composed of relatively homogenous genetic pools is false (P645, 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. (p645, right column; P646, left column).
For another example, Grobkinsky et al (Plant phenomics and the need for physiological phenotyping across scales to narrow the genotype-to-phenotype knowledge gap. Journal of Experimental Botany, Vol. 66, No. 18 pp. 5429–5440, 2015) teach that environmental variation may lead to phenotypic variation within a cultivar (p5430, last 2 paras; p5431, whole page). However, the genetic structure (genotype) is the major determinant of the phenotype of a plant (p5431, fig 2).
For another example, Tibbs-Cortes et al (Comprehensive identification of genomic and environmental determinants of phenotypic plasticity in maize. Genome Research. p1253-1263, 2024) teach that corn/maize phenotypes are determined by the complex interplay of genetics and environmental variables (p1253, Abstract). Tibbs-Cortes et al discovered that flowering time is controlled by some genes or candidate genes. Some genes are significantly influential to maize flowering time than the others (p1256, left col, last para; whole right col; Figure 3). Tibbs-Cortes et al teach that such genotypes are from the parents of the corns (p1259, right col, 3rd para; p1261, left col, 2nd para).
13. Particularly in lettuce plant, or example, Robinson et al (The Genes of Lettuce and Closely Related Species. Plant Breeding Reviews. Chapter 9. P267-293, 1983) teach that 59 loci have been identified, including 6 influencing anthocyanin, 10 chlorophyll genes, 11 affecting leaf morphology, 4 genes influencing heading, 7 genes for flower and seed characteristics, 7 male sterile genes, 1 gene affecting sensitivity to chemicals, and 13 genes for disease resistance. Several cases of multiple alleles and gene linkage are known (p268, 1st para). Lobing of the leaf is under genetic control (p281, 4th para). Lettuce heading is affected by genotype, environment, and genotype-environment interaction (p283, 2nd para). Resistant trait is also related to parents (p287, 2nd para).
For another example, Sharma (Assessment of genetic diversity in lettuce (Lactuca sativa L.) germplasm using RAPD markers. 3 Biotech, p1-6, 2018) teach that both genetic structure and environmental and growing conditions affect features of lettuce. DNA based markers are considered the most suitable for estimation of genetic distances and for characterization of cultivars (p1, right col, 2nd para). It is clear that the cultivars grouped into one cluster are closely related to each other and may have originated from same parental line (p4, right col, 1st para, Fig. 3).
Therefore, a breeding history especially parent lines are essential and the least burdensome way to provide genetic information needed at adequate describe a newly developed plant, including in lettuce plants.
14. To overcome this rejection, the applicant must amend the specification/drawing to provide the breeding history used to develop the instant line or cultivar. When identifying the breeding history, the applicant should identify any and all other potential names for all parental lines utilized in the development of the instant line. For example, if the applicant’s breeding history uses proprietary line names, the applicant should notate in the specification all other names of the proprietary lines, especially publicly disclosed or patented line information. If the breeding history encompasses a locus conversion or a backcrossing process, the 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, the applicant should provide the breeding history of the parent line as well (i.e. grandparents).
The applicant is also reminded that she or he has a duty to disclose information material to patentability. The applicant should also notate the most similar plants which should include any other plants created using similar breeding history (such as siblings of the instant line). 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).
Remarks
By name search, lettuce ‘Sunberg’ was disclosed Enza Zaden’s catalogs as early as 2/2025, after instant filing date. PDFs attached.
Otherwise, instant ‘Sunberg’ has no prior art in patent, patent application or NPL. Prior art does not disclose any corn has all of the physiological and morphological characteristics of instant ‘Sunberg’.
However, the breeding history and parental lines of instant ‘Sunberg’ are missing in the instant specification. When such breeding history and parental lines become available (See the 112a rejection above), the examiner will perform further search.
Contact information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WAYNE ZHONG whose telephone number is (571)270-0311. The examiner can normally be reached 8:30am to 5:00pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bratislav Stankovic, can be reached on 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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/Wayne Zhong/
Primary Examiner, Art Unit 1662