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 .
Claims 1-20 are pending and examined herein on the merits.
Claim Rejections - 35 USC § 112
Applicant’s statement filed on 11/19/2025 has overcome the rejection of the claims as lacking enablement.
Claim Rejections - 35 USC § 112
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 remain rejected under 35 U.S.C. 112(a) 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, at the time the application was filed, had possession of the claimed invention.
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, nor does it provide enough description to be sufficient to aid in the resolution of questions of infringement.
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).
In the instant application, a full examination cannot be conducted because applicant failed to provide a complete breeding history for the instantly claimed plant variety. Specifically, in claim 1, applicant claims a new soybean plant variety. A plant variety is defined by both its genetics (breeding history) and its traits. In the instant application, applicant has only provided a description of the plant traits as seen in the specification and a partial breeding history. In the instant case, the instant variety is disclosed as being a product of a backcrossing method wherein the initial cross is between RM1916A9-C1DNN and AK2613C6-T1LNN wherein the recurrent parent is RM1916A9-C1DNN and wherein the donor parent is AK2613C6-T1LNN. Although the initial cross is part of the breeding history, the reason that this information is considered partial is that in order to describe the genetics of the instant variety, the parental lineage needs to be disclosed and since this is a backcross derived variety it appears to be a locus conversion and as such the genetics would be considered to be very similar to the recurrent parent. In fact, if the recurrent parent is patented and has a claim drawn to a locus conversion it would qualify as prior art, and therefore a full disclosure of the genetics of at least the recurrent parent are required. Although Applicant has provided several US Patents in the instant IDS it is unclear if any provided are drawn to alternative names for the instant recurrent parent or not. The instant application is therefore incomplete as to the breeding history used to produce the claimed plant variety.
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”. 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. 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. (Ex Parte McGowen- Board Decision in Application 14/996,093). In this case, 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 complete breeding history in this case, 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 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 complete 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 Arguments
Applicant's arguments filed 11/19/2025 have been fully considered but they are not persuasive.
Applicant’s urge that the Office’s contentions and mandate to amend the specification are a significant departure from the Office’s examination policy under which many patents have been issued and are not in accordance with well established patent law (see page 4 of Response).
This is not persuasive because firstly, each case is examined on its own merits regarding the state of the art at the time of filing. Any art matures over time, and as a result the scope of allowable subject matter may shift according to what is known at the time of filing. Cultivar cases, soybean in particular have always been evaluated on the basis of traits and genetic background. These two considerations have been consistent since the beginning of such applications before the patent office. Over time, as fewer and fewer unique trait combinations are presented, the reliance upon the ability to show genetic background distinction has necessarily grown. Additionally, over time, the art-accepted understanding of term definitions and scope has matured. Additionally, it is noted that the rejections presented herein on not presented on the basis of case law, but rather on the basis of the statute regarding written description wherein the Examiner has determined a finding of fact regarding the adequateness of the written description contained herein. In short, wherein the instant cultivar appears to be a standard locus conversion of a recurrent parent, RM1916A9-C1DNN, the genetic background of the instant cultivar would be considered to be highly similar to said recurrent parent. Furthermore, if recurrent parent RM1916A9-C1DNN has in fact, been patented under a different name, it is highly likely that an issued claim is drawn to a locus conversion, which would encompass the instantly claimed cultivar and therefore potentially qualify as prior art. Although Applicants have given information regarding the donor line, which is appreciated and helpful, this information does not alleviate the lack of adequate written description set forth as it regards the genetic background of the instant cultivar.
Applicant’s urge that a letter from the Director of the USPTO in responding to current requirements has indicated that a deposit may satisfy the written description requirement (see page 6 of Response).
This is not persuasive because the Examiner does not agree with Applicant’s conclusion regarding this letter. The letter clearly indicates that these are options available to the Office and that the Office is not changing policy regarding the options available to consider written description satisfied. This in no way limits the options of the Examiner in the finding of fact regarding each case as it relates to adequate written description.
In response to the arguments regarding various case laws and not contending each point of cases which do not share all the fact patterns of the instant case, the Examiner reiterates that the finding pf fact for the instant application was made based on the fact pattern of the instant specification, and the state of the art at the time of filing. Applicants duty to disclose extends beyond merely stating their own finding of fact regarding the genetic background or public availability of recurrent line RM1916A9-C1DNN, but disclosing whether or not this line, which by virtue of its predominant presence in the breeding history of the instant cultivar, was available to the public and what other names it has been given in any such public disclosure. This is not an unreasonable request given that patentability is determined upon whether or not the instant cultivar has a genetic background that is distinct from the hundreds of prior art soybean lines that share the trait combinations nearly identically with the instant cultivar.
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 claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRENT T PAGE whose telephone number is (571)272-5914. The examiner can normally be reached M-F 7-4 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 at 5712707058. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRENT T PAGE/Primary Examiner, Art Unit 1663