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
Initialed and dated copy of Applicant’s information disclosure statement (IDS) filed on 07/25/2023 is attached to the instant Office action. The submission is in compliance with the provisions of 37 C.F.R. § 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The disclosure is objected to because the Specification on page 47 (¶00198) lists the accession number under which the inbred corn line CB80 is deposited as “PTA-______”; and also the date of the deposit as “will be made on _________” (page 46, ¶00197). This deposit accession number is not complete and cannot be used to access the deposited seeds. It is assumed that the blank(s) will be replaced with the appropriate deposit accession number(s). It is also assumed that the corresponding date(s) will be inserted.
Appropriate correction is required.
Status of the Claims
Claims 1-32 as filed on 05/19/2023 are pending and are examined in this Office action.
Claim Objections
Claims 1, 3, 5, 9, 21, and 23-24 are objected to because of the following informalities.
Claims 1, 3, 5, 9, 21, and 23-24 recite that the corn line CB80 is deposited as “ATCC Accession No. PTA-______”. This deposit accession number is not complete and cannot be used to access the deposited seeds.
Appropriate correction is required.
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 the second paragraph of 35 U.S.C. 112:
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.
Indefiniteness
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 that the inventor or a joint inventor, or for pre-AIA the applicant, regards as the invention. Dependent claims are included in all rejections.
Claims 1, 3, 5, 9, 21, and 23-24 are indefinite because of the presence of a blank line instead of an ATCC Accession No. The claims recite a plant name – corn line CB80 – without reciting any deposit accession numbers associated with the name. Because the number is not present, it is unclear to which deposit the claims refer. Because “CB80” is not a term otherwise known in the art, one of ordinary skill in the art would not be apprised of what the recited variety was and as such the metes and bounds of the claims are unclear.
Claims 1, 3, 5, 9, 11, and 21-25 are also indefinite in their recitation(s) of “CB80”. Without the deposit number in the independent claims, it is unclear what corn is being referred to.
In the interest of compact prosecution, the claims are nonetheless examined.
The following is a quotation of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), first paragraph:
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.
Written Description
Claims 1-32 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 claims contain 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 claims are directed to an inbred corn line CB80, a sample of seed of said line to be deposited under ATCC Accession No. _____, to methods that utilize such plants, to plants derived from such plants, and to plants having all the physiological and morphological characteristics of the plant.
A. The 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
Section 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 a question of fact that is evaluated by the factfinder (examiner). MPEP § 2163.04 clearly states that “The inquiry into whether the description requirement is met must be determined on a case-by-case basis and is a question of fact. In re Wertheim, 541 F.2d 257, 262, 191 USPQ 90, 96 (CCPA 1976).”
The instant invention is a new inbred corn line KW9EY006. So, the examiner will evaluate what is an adequate written description for a new corn line. In reviewing this question of fact, the examiner analyzed how plant lines and varieties are evaluated in the public domain. The review concluded that generally the minimum requirements for an adequate description of a new plant line or variety has a trait table and genetic information (via a breeding history). In reviewing Applicant’s specification there is a phenotypic description as is seen in Table 1. However, there is no accompanying breeding history in the specification. Because the specification lacks a breeding history and that breeding history is part of the minimum description of a plant line or 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 is sufficient to consider the variety new” (See USDA, “Applying for a Plant Variety Certificate of Protection”, available at https://www.ams.usda.gov/services/pv po/application-help/apply, downloaded 11/18/2025).
The International Union for the Protection of New Varieties of Plants (UPOV) considers breeding history and methodology part of its evaluation of essentially derived plant varieties (UPOV, Explanatory Notes on Essentially Derived Varieties Under the 1991 Act of the UPOV Convention, April 6, 2017, See UPOV EDV Explanatory Notes 14 and 30).
Historically, the USPTO has considered breeding history information when determining the patentability of a new plant line or 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 line or variety. However, because the breeding history was available, these differences were deemed to be obvious and within the natural variation expected in a backcrossing breeding process. Without a breeding history in these cases, a complete comparison with the prior art could not have been possible.
As seen above in Ex Parte C and Ex Parte McGowan, a trait table is insufficient to differentiate lines or varieties by itself. It has been long established that intracultivar heterogeneity exists in crop species. For example, Haun et al., 2011, The Composition and Origins of Genomic Variation among Individuals of the Soybean Reference Cultivar Williams 82, Plant Physiology, Vol. 155, pp. 645-655 teaches that the assumption that elite cultivars are composed of relatively homogenous genetic pools is false (p. 645, left column). Segregation, recombination, DNA transposition, epigenetic processes, and spontaneous mutations are some of the reasons elite cultivar populations will maintain some degree of plant-to-plant variation (p. 645, right column and p. 646, left column). In addition to genetic variation, environmental variation may lead to phenotypic variation within a cultivar (Großkinsky et al., 2015, Plant phenomics and the need for physiological phenotyping across scales to narrow the genotype-to-phenotype knowledge gap, J. Exp. Bot., Vol. 66, No. 11, pp. 5429-5440, at p. 5430, left column, 1st full paragraph, and right column, 2nd full paragraph). In view of this variability, a breeding history is an essential and the least burdensome way to provide genetic information needed to adequately describe a newly developed plant.
The above factual evidence provides a reasonable basis that a breeding history is necessary written description. With this information the examiner has met the initial burden of presenting by a preponderance of evidence why a person of ordinary skill in the art would not recognize in an applicant’s disclosure a description of the invention defined by the claims (See § MPEP 2163.04). Please note, the citations above are not for legal authority, the legal authority relied upon by the examiner is the 35 USC § 112(a) statute. The citations are presented to support the finding of fact that a breeding history is necessary to the adequate description of a plant.
Although not directly relied upon for the above written description position, a complete written description additionally helps drive examination and help with infringement verification.
MPEP § 2163 (I) states “The written description of the deposited material needs to be as complete as possible because the examination for patentability proceeds solely on the basis of the written description. See, e.g., In re Lundak, 773 F.2d 1216, 227 USPQ 90 (Fed. Cir. 1985); see also 54 Fed. Reg. at 34,880 ("As a general rule, the more information that is provided about a particular deposited biological material, the better the examiner will be able to compare the identity and characteristics of the deposited biological material with the prior art.").”
MPEP § 2163(I) states “The description must be sufficient to permit verification that the deposited biological material is in fact that disclosed. Once the patent issues, the description must be sufficient to aid in the resolution of questions of infringement." Id. at 34,880.)” (Quoting the Deposit of Biological Materials for Patent Purposes, Final Rule, 54 Fed. Reg. 34,864 (August 22, 1989) at 34,880).
The breeding history aids in the resolution of patent infringement by providing information necessary to determine whether differences in the plants are genetic differences, differences caused by the environment, or differences within the accepted variation within a line or 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, including the parents, is not known to the public, the public could only rely on the phenotypes of the claimed plants for assessing potential infringement.
Thus, an application that does not clearly describe the breeding history does not provide an adequate written description of the invention.
To overcome this rejection, Applicant must amend the specification/drawing to provide the breeding history used to develop the instant line. 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 line and all other potential names for the claimed line. If Applicant’s breeding history uses proprietary line or variety names, Applicant should notate in the specification all other names of the proprietary lines or varieties, especially publicly disclosed or patented line and variety information. If the breeding history encompasses a locus conversion or a backcrossing process, Applicant should clearly indicate the recurrent parent and the donor plant and specifically name the trait or transgenic event that is being donated to the recurrent parent. If one of the parents is a backcross progeny or locus converted line of a publicly disclosed line, Applicant should provide the breeding history of the parent line as well (i.e., grandparents). Applicant should identify the breeding method used, such as single seed descent, bulk method, backcross method, etc., and the filial generation in which the instant plant was chosen. Information pertaining to the homozygosity or heterozygosity of the parents as well as the instant plant should be set forth.
Applicant is reminded that they have a duty to disclose information material to patentability. Applicant should also notate the most similar plants which should include any other plants created using similar breeding history (such as siblings of the instant variety). If there any patent applications or patents in which sibs or parents of the instant plant are claimed, the serial numbers and names of the sibs or parents should be disclosed. This information can be submitted in an IDS with a notation of the relevancy to the instant application or as information submitted as described in MPEP 724 (e.g., trade secret, proprietary, and Protective Order).
35 USC § 112(a) clearly states “The specification (emphasis added) shall contain a written description of the invention”. In the instant application, Applicant has not provided adequate breeding history for inbred corn line CB80 in the Specification. This disclosure is insufficient because it does not address all the issues set forth above. Thus, the breeding history for the claimed line as disclosed in the Specification is incomplete. Therefore, the complete breeding history for producing the claimed line, including all names for the parents and for the claimed line, are material for patentability. A specification devoid of a complete breeding history hampers the public’s ability to fully resolve questions of infringement.
B. Claim 26 is drawn to a corn seed or part thereof produced by the method of claim 25. Claim 25 is drawn to methods of introducing transgenes into a corn plant and includes in its scope outcrossing the corn plant of claim 2 multiple times without limit as long as the first cross uses the plant of claim 2. Thus, this scope includes a very broad genus of corn plants, many of which would share few characteristics with the instantly claimed variety.
C. Claim 28 is drawn to hybrid seed produced by crossing the plant of claim 22 with a different corn plant. The corn plant of claim 22 is made by a method that would only require a single backcross to CB80. Thus, the hybrid claimed in claim 28 would encompass many plants that share less than 50% identity to CB80.
The instant disclosure describes corn variety CB80 and F1 hybrids of CB80 (note that all of these F1 hybrids share 50% of the genome with CB80).
These descriptions are insufficient, because they fail to describe a scope of corn plants beyond F1 plants and certainly do not describe the very broad scope encompasses in claim 26.
Hence, Applicant has not, in fact, described the corn plants of claims 26 and 28, and the specification fails to provide an adequate written description of the claimed invention.
Therefore, given the lack of written description in the specification with regard to the structural and functional characteristics of the claimed compositions, Applicant does not appear to have been in possession of the claimed genus at the time this application was filed.
Enablement
Claims 1-32 are rejected under 35 U.S.C. § 112(a) or 35 U.S.C. § 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claims contain subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The invention appears to employ novel plants. The claims all require seed of inbred corn line CB80. The claims are directed to seeds and plants of corn line CB80, to plants and plant parts derived from said variety, and to the methods of using said line.
Since the seeds and plants claimed are essential to the claimed invention, they must be obtainable by a repeatable method set forth in the specification or otherwise be readily available to the public. If the seed or plant is not so obtainable or available, the requirements of 35 U.S.C. § 112 may be satisfied by a deposit of the seeds. A deposit of 625 seeds of each of the claimed embodiments is considered sufficient to ensure public availability. The specification does not disclose a repeatable process to obtain the exact same seeds and plants in each occurrence and it is not apparent if such a seed and plant is readily available to the public.
It is noted that Applicant provides a statement in the Specification on pages 46-47 (¶¶00197-0206) that appears to indicate an intent to make a deposit of corn line CB80 seeds, but at this time, no deposit number or date is provided and as such the deposit requirement is not satisfied. The Deposit statement must indicate if the deposit is made under the Budapest Treaty or that it otherwise complies with the requirements of 37 CFR § 1.808(a)(2). Further, pursuant to MPEP § 2409, the statement should indicate that the deposit has been accepted.
If the deposit of these seeds 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 that the seeds 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 a 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 and MPEP 2402-2411.05, Applicant 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:
(i) during the pendency of this application, access to the invention will be afforded to the Commissioner upon request;
(ii) all restrictions upon availability to the public will be irrevocably removed upon granting of the patent in accordance with 37 CFR § 1.808(a)(2);
(iii) 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 effective life of the patent, whichever is longer;
(iv) evidence will be provided of the test of the viability of the biological material at the time of deposit (see 37 CFR § 1.807); and,
(v) the deposit will be replaced if it should ever become inviable (see 37 CFR § 1.807).
In addition, the identifying information set forth in 37 CFR § 1.809(d) should be added to the specification. See 37 CFR §§ 1.801 - 1.809 [MPEP 2401-2411.05] for additional explanation of these requirements.
Summary
Claims 1-32 are deemed to be provisionally free of the prior art, given the failure of the prior art to teach or suggesting a corn plant having all of the morphological and physiological characteristics of the inbred corn line CB80. It should be noted that this statement is based only on a comparison of the morphological and physiological characteristics of the deposit against the prior art. This statement is provisional because Applicant has not provided any information regarding the parental lineage or breeding methodology used to produce the claimed corn line. Without this information, a meaningful comparison of the genetic and phenotypic basis that would distinguish the claimed corn line from prior art plants cannot be made. Thus, this statement will remain provisional until the necessary information requested above is received, corrections are made to the description, and a complete search of the prior art can be completed.
No claim is allowed.
Examiner’s Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRATISLAV STANKOVIC whose telephone number is (571) 270-0305. The examiner can normally be reached Monday-Friday, 08:00-17:00 h 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, Amjad Abraham can be reached on (571) 270-7058. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
BRATISLAV STANKOVIC, PhD, JD
Primary Patent Examiner
Art Unit 1663
/BRATISLAV STANKOVIC/Primary Examiner, Art Unit 1663
Prosecution Insights