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
The claim set was amended 9/26/2024. New claims 15-16 were added by the applicant.
Claims 1-16 are pending and examined in this office action.
Priority
Instant application 18778900, filed 07/19/2024, claims foreign priority to 2023-118653, filed 07/20/2023.
However, both a certified copy of foreign application and an English translation are missing. Thus, the priority is recognized as 07/19/2024 until both a certified copy of foreign application and an English translation are received and disclose the claimed subject matter.
Claim Objections
Claims 1-19 are objected to because of the following informalities:
Claim 1 recites “deposited under Accession No. FERM BP-22478”. However, the deposit agent (like ATCC, NCIMB, or other authorized agents or organizations) is missing. In this particular application, the deposit agent appears to be “NITE-IPOD” according to the specification (p1, lines 1-7).
The following suggestions are made for correcting informalities:
Claims 6-7 use a wrong article. The “A lettuce plant” should be ---The lettuce plant---.
In addition, claim 6 misses an article. The “mutation” in line 2 should be ---a mutation---.
In addition, in claim 6, line 2, the “includes” is suggested to be changed to --comprises--.
Claim 8 misses more than one articles. In line 5, “time” should be ---the time---; in line 6, “resistance” should be ---the resistance---.
Claims 13-14 miss an article. The “mutation” in line 2 of both claims should be ---a mutation---.
Additionally, claims 2-16 recite “according to”. It is suggested to be changed to ---of-
The claims appear to be a literal translation into English from a foreign document and are replete with grammatical and idiomatic errors, failing to conform current U.S. practice.
See the requirement of 37 CFR 1.71(a) for “full, clear, and exact terms”.
Appropriate correction is 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 1-16 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 line TEXLE203026, a plant part, tissue culture, method of using the plant, and more.
The lettuce line TEXLE203026 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 the Accession No. FERM BP-22478 is recited in claim 1. The examiner also noticed that in the specification (page 3, last para; and page 4, 1st pare): “<Deposited Line> The lettuce plant of the present disclosure is designated as TEXLE203026, and a representative example thereof is a lettuce plant identified by Accession No. FERM BP-22478 or a progeny line thereof. Hereinafter, the lettuce plant identified by Accession No. FERM BP-22478 is also referred to as a lettuce line TEXLE203026. Information on the deposit of this variety is shown below. (TEXLE203026)
Type of deposit: International deposit
Name of depository institution: National Institute of Technology and Evaluation, International Patent Organism Depositary; NITE-IPOD
Address: 2-5-8-120, Kazusakamatari, Kisarazu-shi, Chiba 292-0818, Japan
Accession number: FERM BP-22478
Identifying designation: TEXLE203026
Date of acceptance: May 18, 2023”.
However, according to MPEP 2402 and 37 CFR 1.801, the deposit must be intended to meet all of the requirements of the Budapest Treaty and 37 C.F.R. § 1.801-1.809, which sets forth examining procedures and conditions of deposit which must be satisfied in the event a deposit is required.
In this case, the statement of the “deposit is intended to meet all of the requirements of the Budapest Treaty and 37 C.F.R. § 1.801-1.809” is missing in the specification. The statement of “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)” is also missing.
In addition, the NITE-IPOD receipt of the deposit is missing.
Moreover, in the claim(s), the deposit agent is missing.
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.
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.
Claims 1-16 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.
Claim 1 recites an accession number without deposit agent, thus are not complete. According to MPEP 2173, where possible, claims are to be complete in themselves.
In addition, the deposit has not been shown to be satisfactorily made and accepted.
Moreover, the parent lines and breeding history of the lettuce line TEXLE203026 are not disclosed by the applicant. Thus, the genetic background of the lettuce line TEXLE203026 is unknown.
Therefore, TEXLE203026 is not an art recognized or accepted term.
Dependent claims do not cure the deficiency.
Appropriate corrections are required.
Claims 3 and 8 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.
Claim 3 recites “essentially all of the physiological and morphological characteristics”. 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 TEXLE203026 in page 5, Table 1. It is unclear which characteristics of TEXLE203026 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 TEXLE203026 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.
Claim 8 depends on claim 2. However, the “the size of a head”, “the time of beginning of bolting” and “the resistance to Fusarium oxysporum f. sp. Lactucae (Fol) Race 1”, do not have proper and/or sufficient antecedent bases in claim 2 or claim 1. Claim 2 or claim 1 does not recite any of the characteristics. Thus, the claim is indefinite. See MPEP 7.34.05.
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.
Claims 1-16 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.
The rejection is made because the specification fails to disclose the breeding history and parent lines of the instant lettuce TEXLE203026.
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 TEXLE203026, 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 some representative characteristics/traits of TEXLE203026 (page 5, Table 1). However, instant specification does not describe the breeding history, particularly the parent line(s), of the claimed TEXLE203026. 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.
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.
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 1 in page 5) is insufficient to differentiate varieties by itself. It has been long established that intracultivar heterogeneity exists in crop species.
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).
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.
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).
Further regarding claims 6, 8, 15-16
Claim 6 is broadly drawn to a genus of lettuce plants of a lettuce line TEXLE203026 further comprises a genus of mutations.
According to the specification (p29, last para), mutations of the lettuce plant is modified by mutagenesis.
The specification only describes lettuce line TEXLE203026, which does not further comprise any mutation, not to mention a genus of generic non-specific mutations. However, the specification fails to describe any species, not to mention a genus of plants, further comprising any mutation, not to mention a genus of generic non-specific mutations.
In addition, in prior art, mutagenesis techniques introduce genomic modifications in a random and unpredictable fashion, which will certainly not resemble the starting variety either genetically or phenotypically. For example, Mou (Mutations in Lettuce Improvement. International Journal of Plant Genomics, p1-7, 2011) demonstrated that random mutagenesis, naturally occurring, or induced by chemical (EMS) and physical (Gama ray) mutagens, caused major changes of physiological and morphological characteristics in lettuce including dwarf, male sterile, reduced diameter, loss of resistance to disease and so on (page 2, table 1).
Thus, the plants of TEXLE203026 further comprising mutations do not likely maintain the morphological and physiological characteristics of TEXLE203026.
Regarding claims 8, 15-16, claim 8 is broadly drawn to a genus of progeny lines lettuce plants, wherein the progeny line includes at least 50% of alleles of a lettuce line TEXLE203026. Since the progeny line is not limited to F1 generation, the claimed progeny plants encompass beyond F1 to undefined filial generations.
The specification only describes lettuce line TEXLE203026, as analyzed above, the parental lines of TEXLE203026 and the breeding history are not described.
The plants above read on F1, F2, F3, etc... filial generation. These claims are “reach through” claims in which the applicant has described a starting material and at least one method step, however, they have not described the resulting product, and the genus of products that can be produced by the recited method steps and materials is so large that one of skill in the art is not able to envision the members of the genus. (See Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 920-23, 69 USPQ2d 1886, 1890-93 (Fed. Cir. 2004)).
In the art, it is well known that the traits of the product of a given cross between two lettuce plants are unpredictable. For example, Knerr et al (US patent 7371930) teaches that the “complexity of inheritance influences choice of the breeding method” (col 2, lines 4-5). “A most difficult task is the identification of individuals that are genetically superior, because for most traits the true genotypic value is masked by other confounding plant traits or environmental factors" (col 2, Iines. 36-39). “The breeder has no direct control at the cellular level. Therefore, two breeders will never develop the same line, or even a very similar line, having the same lettuce traits" (col 2, Ins 50-53). "A breeder of ordinary skill in the art cannot predict the final resulting lines he develops, except possibly in a very gross and general fashion. The same breeder cannot produce the same line twice by using the same exact original parents and the same selection technique" (col 2, Ins. 63-67). Thus, the art clearly recognizes that there is great unpredictability and many uncontrollable factors when breeding lettuce varieties. Thus, plant breeding is highly unpredictable and even when crossing the same two parents, one will not necessarily produce the same products of the cross. Even when crossing two inbred parent plants, a breeder cannot predict the phenotype of a given cross until the cross is made given the complexity of inheritance and the multi-genic pathways controlling the traits.
Therefore, the progeny seeds and plants from generations beyond F1, do not likely have the same physiological and morphological characteristics of the lettuce TEXLE203026 (the deposited line).
Dependent claims 15-16 do not cure the deficiency. In contrary, they depend on claim 8 not claim 2, and recite progeny line. Thus, the claimed progeny line and hybrid line encompass further off from the original TEXLE203026 line.
Regarding the representative number of species, again, the specification only describes lettuce TEXLE203026, the parental lines of TEXLE203026 and the breeding history are not described.
The genus of plants encompasses unlimited generations (F1, F2, F3, etc... filial generation) of plants, thus the number is near infinite.
Since mutations are random and generic and can be in all positions of the genome, and can have insertions, deletions, and substitutions of any size and structure, the genus of plants produced by mutagenesis, thus the number is near infinite.
Lettuce TEXLE203026 does not demonstrate the characteristics of the genus of progeny seeds and genus of plants, or the genus of mutant plants by mutagenesis. Lettuce TEXLE203026 also is not sufficient to represent the genus of progeny plants, or the genus of mutant plants by mutagenesis.
Given the lack of disclosure of broadly claimed genus as discussed above, any ordinary skill in the art would not have recognized that the applicant had the possession of the genera as claimed.
Therefore, the application has not met either of the two elements of the written description requirement as set forth in the court' s decision in Eli Lilly, and has not shown her/his possession of the claimed genera.
Remarks
By name search, instant TEXLE203026 has no prior art in patent, patent application or NPL. Prior art does not disclose any lettuce has all of the physiological and morphological characteristics of instant TEXLE203026.
However, the breeding history and parental lines of instant TEXLE203026 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.
Conclusion
No claim is allowed.
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