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 .
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Applicant’s response filed 09/08/2025 and the supplemental response filed 09/30/2025 have been entered. Claims 1, 6, 13-15 and 18 are amended. Claims 1-20 are pending.
Withdrawn objections and rejections
The 112(a) and (b) rejections regarding “variety” have been withdrawn in view of Applicant’s amendment to the claims. The 112(a) rejection to the claims regarding the deposit requirement has been withdrawn in view of Applicant’s statement on pages 5-6 of the response filed 09/30/2025 .
All previous objections and rejections not set for below have been withdrawn in view of Applicant’s amendment to the claims and/or upon further consideration.
Written Description Rejection-Missing of breeding history
Claims 1-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This rejection is repeated for the reasons of record as set forth in the last office action. Applicant’s arguments filed 08/19/2025 have been fully considered but are not deemed persuasive.
As stated in the last office action, in the instant application, a full examination cannot be conducted because applicant failed to provide the parental lines and breeding history for the instantly claimed plant variety. Applicant claims a new soybean variety CL1561938. A plant variety is defined by both its genetics (deposit and breeding history) and its traits. In the instant application, applicant has only provided a description of the plant traits as seen in the specification. The instant application is silent as to the breeding history used to produce the claimed plant variety.
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 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 Variety Protection (PVP) applications. That information is used to “determine if development is sufficient to consider the variety new” (See “Applying for a Plant Variety 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 variety. Historically, the USPTO has considered breeding history information when determining the patentability of a new plant variety. (See Ex Parte C (USPQ 2d 1492 (1992) and Ex Parte McGowen- Board Decision in Application 14/996,093). In both of these cases, there were many differences cited by the applicant when comparing the prior art and the new plant variety. However, because the breeding history was available, these differences were deemed to be obvious and within the natural variation expected in a backcrossing breeding process. Without a breeding history in these cases, a complete comparison with the prior art could not have been possible.
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.
As seen above in Ex Parte C and Ex Parte McGowan, a trait table is insufficient to differentiate varieties by itself. It has been long established that intracultivar heterogeneity exists in crop species. HAUN teaches that the assumption that elite cultivars are composed of relatively homogenous genetic pools is false. (See Haun Page 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. (See Haun Page 645 right column and Page 646 left column). In addition to genetic variation, environmental variation may lead to phenotypic variation within a cultivar. (See Großkinsky page 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 at adequate describe a newly developed plant.
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 variety or cultivar. 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 variety. For example, if applicant’s breeding history uses proprietary line names, 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, 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 is also 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). 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).
Response to Applicant’s Arguments
Applicant argues that all claims meet the written description requirement. Applicant relies upon the following points to support this position: 1) the deposit of the seed of the claimed variety together with the phenotypic characteristics listed on Tables 9 and 10 of the specification are sufficient to satisfy the written description requirement. 2) In each of Ex Parte C and Inari Agriculture, the deposited seed that is available to the public was found to be sufficient to describe the claimed cultivar and that the Ex parte C decision does support Applicant’s position that the instant claims meet the written description requirement . 3) The requirement of breeding history to satisfy written description contradicts the Federal circuit’s holding in Ariad that written description is about showing that Applicant is in possession of the claimed invention rather than showing the breeding history of the claimed cultivar. 4) Applicant attaches Appendix A and asserts that the breeding history is not a requirement for written description under 112 and USPTO rules. Applicant contends that Rule 105 information Request is the proper remedy for obtaining the breeding history information to facilitate examination. 5) Applicant argues “that the written description serves to ensure the inventor had possession of what is claimed, not to facilitate examination.
These are not found persuasive because of the following: 1) while the deposit of the seed of soybean CL1561938 is sufficient to satisfy 112(a) regarding the enablement requirement, the deposit is supplemental to the written description requirement and is NOT a substitute of the written description. The MPEP 2163 states the following:
Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406; Amgen, Inc. v. Chugai Pharm., 927 F.2d 1200, 1206, 18 USPQ2d 1016, 1021 (Fed. Cir. 1991) (one must define a compound by "whatever characteristics sufficiently distinguish it"). "Compliance with the written description requirement is essentially a fact-based inquiry that will ‘necessarily vary depending on the nature of the invention claimed.’" Enzo Biochem, 323 F.3d at 963, 63 USPQ2d at 1612. An application specification may show actual reduction to practice by describing testing of the claimed invention or, in the case of certain biological materials, by specifically describing a deposit made in accordance with 37 CFR 1.801 et seq. See Enzo Biochem, 323 F.3d at 965, 63 USPQ2d at 1614 ("reference in the specification to a deposit may also satisfy the written description requirement with respect to a claimed material"); see also Deposit of Biological Materials for Patent Purposes, Final Rule, 54 Fed. Reg. 34,864 (August 22, 1989) ("The requirement for a specific identification is consistent with the description requirement of the first paragraph of 35 U.S.C. 112, and to provide an antecedent basis for the biological material which either has been or will be deposited before the patent is granted." Id. at 34,876. "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.) Such 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.").
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Further, even if Applicant insists the deposit together with phenotypic traits listed on Tables 9 and 10 are sufficient to provide sufficient written description to soybean plant/seed soybean CL1561938 , the claims are not limited to soybean plant/seed soybean CL1561938 but includes F1 hybrid plants and seed of CL1561938 variety. The F1 hybrid is produced by crossing a plant of the soybean CL1561938 (unknown parental lines) with any second soybean plant of a different genotype. It is clear in this case that Applicant is expecting from the public to determine what distinguishes his own soybean CL1561938 using the publicly available deposited seed, while the specification does not provide any markers or marker information specific for the claimed soybean CL1561938.
The law is clear that it is the specification itself that has to provide the complete written description including the breeding history of the claimed variety. The quotation of the first paragraph of 35 U.S.C. 112(a) CLEARLY states:
(a) IN GENERAL.—The specification shall contain a written description of the invention, ………
There is no information in the specification regarding the identity of the parental lines that produces the claimed soybean cultivar CL1561938. Further, the specification does not provide any markers or marker information specific for the claimed cultivar, so that the public can use the deposited seed to genotype the soybean cultivar CL1561938.
2) Ex Parte C and Inari are cited in the office action not to clarify the law but to show that a trait table alone is insufficient to differentiate varieties by itself. The references, the MPEP portions and related case laws are cited in the office action to show what is considered to be an adequate written description. They are not cited for legal analysis. The cited references establish that the breeding history and parental lines are a part of the written description of a plant variety in the art of plant variety. Applicant is, therefore, required to disclose the breeding history and parental lines to provide a sufficient written description for the claimed soybean variety. The law under 35 USC 112 (a) is clear that it is Applicant’s own specification that has to provide sufficient written description and the distinguishing characteristics of their claimed cultivar. Applicant has provided no evidence to the contrary. 3) The requirement of breeding history does not contradict the court in Ariad because nowhere in the court decision that suggests breeding history is not required to satisfy written description. 4) Appendix A attached to the response is noted. However, contrary to Applicant’s arguments, the requirement to disclose the identity of the parental lines used to produce the claimed soybean CL1561938 is NOT an “additional guidance”. The requirement to disclose breeding history is an existing guidance as evidenced by the Rule 105 Information request that the office had in place for a while. However, the office determined that the written description rejection is more appropriate and convenient for both the Applicant and the office that the breeding information be provided in the specification, given that the Rule 105 is neither rejection nor an objection and that Applicant may or may not respond to it, and given that the first 10 words in the quotation of the 35 USC 112(a) regarding written description, states:
(a) IN GENERAL.—The specification shall contain a written description of the invention, ………
Further, Applicant’s argument “that the written description serves to ensure the inventor had possession of what is claimed, not to facilitate examination, is not found persuasive because one cannot ensure the inventor’s possession of the claimed invention without the analysis of what is described in the specification; this analysis include the breeding history and parental lines in plant utility art for a new plant variety claims. Further, it is unclear why Applicant would insist that the Office submit Rule 105 request in order to disclose the identity of the parental lines used in the breeding of soybean CL1561938, when the same the response applies to both the 105 request and the written description rejection.
For all the reasons discussed above and in the last office action, the rejection is proper and maintained.
Remarks
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
No claim is allowed.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MEDINA AHMED IBRAHIM whose telephone number is (571)272-0797. The examiner can normally be reached Monday-Friday, 9:00 - 6:00.
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 ZHOU can be reached at 5712720724. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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MEDINA AHMED. IBRAHIM
Primary Examiner
Art Unit 1662
/MEDINA A IBRAHIM/ Primary Examiner, Art Unit 1662