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 Statements
The Information Disclosure Statements filed on 5/30/2024 have been entered and considered. Initial copies of the form PTO-1449 are enclosed with this action.
Status of claims
Claims 1-32 are pending and examined.
Priority
Instant application, filed on 4/25/2024, does not have priority applications.
Object to the specification
The specification is objected because of some blanks are disclosed.
For example, in [00197], “The deposit for the inbred corn line KW4MT1806 will be made on ----“. The “----" should be a real date. In [00198], the ATCC Accession No. PTA-___, the ___ should be a real accession no.
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 1-32 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 inbred corn line designated KW4MT1806, a plant part, tissue culture, method of using the corn plant, and more.
The corn line KW4MT1806 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 ([00197]-[00206]): “A deposit of the inbred corn line of this disclosure is maintained by AgReliant Genetics, LLC, 972 County Rd 500 E., Ivesdale, Illinois 61851. AgReliant maintains the seed deposit on behalf of Limagrain Europe S.A. and KWS SAAT SE & Co. KGaA. In addition, a sample of the inbred corn seed of this disclosure has been deposited with the American Type Culture Collection, 10801 University Boulevard, Manassas, Virginia 20110. The deposit for the inbred corn line KW4MT1806 will be made on ----. To satisfy the enablement requirements of 35 U.S.C. 112, and to certify that the deposit of the isolated strain (i.e. corn inbred) of the present disclosure meets the criteria set forth in 37 CPR 1.801-1.809 and Manual of Patent Examining Procedure (MPEP) 2402-2411.05, Applicants hereby make the following statements regarding the deposited inbred corn line KW4MT1806 (deposited as ATCC Accession No. PTA-___ ) If the deposit is made under the terms of the Budapest Treaty, the instant disclosure will be irrevocably and without restriction released to the public upon the granting of a patent. If the deposit is made not under the terms of the Budapest Treaty, Applicant(s) provides assurance of compliance by following statements:
1. During the pendency of this application, access to the disclosure will be afforded to the Commissioner upon request;
2. All restrictions on availability to the public will be irrevocably removed upon granting of the patent under conditions specified in 37 CPR 1.808;
3. The deposit will be maintained in a public repository for a period of 30 years or 5 years after the last request or for the effective life of the patent, whichever is longer;
4. A test of the viability of the biological material at the time of deposit will be conducted by the public depository under 37 CPR 1.807; and
5. The deposit will be replaced if it should ever become unavailable.
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 granting of any claims in this application, all restrictions on the availability to the public of the line will be irrevocably removed by affording access to a deposit of at least 625 seeds of the same line with the ATCC”.
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 ATCC 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.
Claims 1-32 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, 3, 5, 9, 21, 23-24) recite blanks “PTA-____” after ATCC 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 inbred corn line KW4MT1806 has not been made and accepted (as analyzed above).
Moreover, the parent lines and breeding history of inbred corn line KW4MT1806 are not disclosed by the applicant. Thus, the genetic background of KW4MT1806 is unknown.
Therefore, KW4MT1806 is not an art recognized or accepted term.
Dependent claims do not cure the deficiency.
Appropriate corrections are required.
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 1-20 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 inbred corn line KW4MT1806. 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).
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 inbred corn line “KW4MT1806”, a new corn 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 description of the plant traits as seen in the specification (Table 1 in page 25-27; Tables 2-6 in pages 50-51). The instant specification does not describe the breeding history, particularly the parent line(s), of the claimed corn “KW4MT1806”. In another word, the instant application is silent or incomplete as to the breeding history used to produce the claimed plant line.
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 25) is insufficient to differentiate varieties by itself. It has been long established that intracultivar heterogeneity exists in crop species.
In the art, 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).
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).
Particularly in corn line plants, Nannas et al (Genetic and Genomic Toolbox of Zea mays. Genetics. Genetics, Vol. 199, 655–669, 2015) teach that a particular species of maize or corn is determined by its genes in the chromosomes of its genome (p659, left col, last para; right col, 1st and 2nd paras). Nannas et al teach that purely homozygous inbred lines such as B73 are specially derived lines that have been selected to maintain reasonable vigor while performing well in commercial hybrids (p661, left col, 1st para). Nannas et al teach that both female parent and male parent are critical in determining the outcome of a corn progeny (p656, left col, 1st para).
Recently, 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).
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.
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).
Claims 7-8, 12-18, 20, 26, 28 are additionally 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.
To claim a genus under the written description requirement, the applicant is required to describe a representative number of species to reflect the variation within the genus or structures sufficient to define the genus. The factors to be considered include disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, or any combinations thereof.
By court' s statement in Regents of the Univ. of Cal. v. Eli Lilly, 119 F.3d 1559, 1566, 43 USPQ2d 1398, 1404 (Fed. Cir. 1997), a written description of an invention “requires a precise definition, such as a structure, formula, or chemical name, of the claimed subject matter sufficient to distinguish it from other materials”; further, a written description of a claimed genus requires a description of a representative number of species of the claimed genus, and one of skill in the art should be able to “visualize or recognize the identity of the members of the genus”.
Regarding claims 7-8, the claims are drawn to a hybrid corn seed produced by the method of claim 6 (crossing the plant of claim 2 (KW4MT1806) with a different corn plant, and harvesting the resultant hybrid corn seed), and an F1 hybrid corn plant, or part thereof, produced by growing the seed of claim 7.
Please note that the seed of claim 7 is not required to be F1 hybrid seed, thus claim 7 is broadly drawn to a genus of hybrid seeds that are F2 and beyond.
The specification does not describe any F2 progeny seed of KW4MT1806, inbred or hybrid, not to mention the common structure feature of F2 progenies and beyond.
In the art, Stitzer et al (Maize domestication and gene Interaction. New Phytologist, 220: 395–408, 2018) teach that in F2 cross or backcross of a teosinte/corn, although maize alleles are dominant to teosinte alleles in a maize background, dominance relationships shift when alleles are segregating in an F2, a teosinte backcross, or a maize backcross (p402, left col, 3rd to 4th para, right col, 1st para).
Thus, the seed of claim 7 and the F1 (relevant to claim 7 not claim 6) plant of claim 8 are not likely maintain the physiological and morphological characteristics of KW4MT1806.
Regarding claims 12-18, 20, 26, according to the specification ([0007]), The term "a" or "an" refers to one or more of that entity; for example, "a gene" refers to one or more genes or at least one gene. As such, the terms "a" (or "an"), "one or more" and "at least one" are used interchangeably herein.
Thus, the claims are broadly drawn to a genus of corn plants comprising a genus of transgenes.
The claims do not require the plants otherwise comprise all of the physiological and morphological characteristics of KW4MT1806. Additionally, the plants and parts of claim 12 are not required to be F1 generation.
The specification only describes representative characteristics of KW4MT1806, which does not further comprise any transgene. The specification does not describe any corn plant of KW4MT1806 further comprising a transgene, not to mention the common structure feature of the genus of plants.
In the art, Mesnage et al (An integrated multi-omics analysis of the NK603 Roundup-tolerant GM maize reveals metabolism disturbances caused by the transformation process. Nature Scientific Reports. 1-14, 2016) teach that in maize, unintended changes like rearrangements, insertions or deletions in the genome occur in transformation processes, and could be a safety issue in genetically modified plants (p7, last para). Mesnage et al also teach that transgenes cause phenotypical changes directly or indirectly through environmental stress (p8, 2nd para; Table 2).
Given that the transgenes are not specific but generic, the claimed genus does not have any common structure and are heterologous in structure, physiological, and morphological characteristics.
Dependent claims 13-18 do not cure the deficiency.
Regarding claim 28, the claim is drawn to a genus of hybrid corn seeds produced by the method of claim 27 (crossing the plant of claim 22 with a different corn plant, and harvesting the resultant hybrid corn seed).
Note: claim 22 is drawn to a corn plant produced by the method of claim 21 (a method of backcrossing) wherein the plant has the one or more desired traits and otherwise all of the physiological and morphological characteristics of inbred corn line KW4MT1806.
According to the specification ([0020]-[0021]), a trait can be introduced to KW4MT1806 by breeding or transformation (of transgenes). “a” trait or transgenes refers to more than one.
The plant of claim 22 is deemed described because it is a backcrossed plant and is required to has the one or more desired traits and otherwise all of the physiological and morphological characteristics of inbred corn line KW4MT1806. The plant of claim 22 is a least a F1 progeny seed.
However, the seed of claim 28 is a progeny seed of claim 22, and is at least a F2 hybrid seed from KW4MT1806. In addition, the seed further comprises more than one transgenes/traits.
The specification does not describe any species of such corn seed.
In addition, as analyzed above, in the art, in F2 cross or backcross of a corn, the genotypes and resultant phenotypes are likely changed.
Also as analyzed above, in the art, transgenes likely change the physiological and morphological characteristics of corns.
Regarding the aspect of representative number of species, KW4MT180 is a species of F0, and does not comprise any additional transgene or trait.
The genus of claimed seeds, plants, plant parts, are generic and heterogeneous in structure, and encompass an extremely large number. The claimed genus does not have any common structure and are heterologous in structure, physiological, and morphological characteristics. The plants and seeds beyond F1 generation also encompass an extremely large number, and as analyzed above, are heterologous in structure, physiological, and morphological characteristics.
Thus, KW4MT1806 comprising no additional transgenes or introduced traits, does not describe the common structure feature of the genus of corn plants and/or seeds, and does not represent (not to mention sufficiently) the genus of corn plants and/or seeds.
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.
It is suggested to amend claim 7 to recite a F1 corn seed, to amend claim 12 to recite a F1 corn plant or plant part and to recite comprising otherwise all of the physiological and morphological characteristics of inbred corn line KW4MT1806, and to amend claims 20 and 26 to recite plant grown from the seed comprising otherwise all of the physiological and morphological characteristics of inbred corn line KW4MT1806, to overcome the rejections.
Claim 28 is drawn to F2 seed and beyond. It is suggested to cancel the claim.
Remarks
By name search, instant corn line KW4MT1806 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 KW4MT1806.
However, the breeding history and parental lines of instant KW4MT1806 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.
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, Shubo (Joe) Zhou can be reached on 571-272-0724. 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