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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 03/02/2026 has been entered.
Claim Status
Claims 1-17 remain pending.
Claims 1-17 are rejected.
Specification
Applicant’s amendment to the specification filed on 03/02/2026 has necessitated this new objection. Specifically, the amendment to add the pedigree section to the specification. This amendment requires a new objection to address what appears to be a typographical error. Accordingly, this new objection to the specification is presented below.
The disclosure is objected to because of the following informalities: in the new paragraph added to the specification directly after the last paragraph on page 45 in applicant’s amended specification dated 03/02/2026, the instant variety name is misspelled, rather than CL2042637, the specification in the first line of the Pedigree refers to the elite soybean variety CL20243637.
Appropriate correction is required.
Claim Rejections - 35 USC § 112 (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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
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.
Applicant’s amendment to the specification filed on 03/02/2026 has necessitated this new ground of rejection. Specifically, the amendment to add the pedigree section to the specification. This amendment requires a new analysis to appropriately address the two distinct scopes imparted into plants of the claimed variety given the language provided in the specification which describes the breeding history of the instant variety. Accordingly, this new ground of rejection is being presented below.
Claims 1-17 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1, 6, 11 and 13-15, are rejected as being indefinite in their recitation “soybean variety CL2042637” because the recitation does not clearly identify the claimed plant variety and seed. Furthermore, the recitation does not set forth the metes and bounds of the claimed invention. Since the name “soybean variety CL2042637” is not known in the art, the use of said name does not carry art recognized limitations as to the specific characteristics or essential characteristics that are associated with that denomination. However, applicant has provided a deposit which clarifies the phenotypic characteristics of the claimed variety. However, the genetic features of the variety are provided in the Pedigree section of the amended specification date 03/02/2026. However, this pedigree introduces two different scopes of the claimed invention. Specifically, given the language of the pedigree there appear to be two different interpretations of the steps taken to produce the claimed variety which would inherently impart different genetic characteristics of the claimed variety and therefore two distinct scopes of the claims.
For clarity the language of the specification is provided as follows: “Pedigree: CW1660237//EE1660700/15 PB60045-22. CL20243637 is an elite soybean variety originating from a cross between variety CW1660237 (commercially known as S007-B7X) and the progeny of EE1660700/15 PB60045-22 (neither of which are commercially available) via backcrossing.”
The indefiniteness is due to the final two words. Specifically, it is not clear whether “via backcrossing” refers to the production of CL2042637 by backcrossing CW1660237 and the progeny of the cross between EE1660700/15 PB60045-22 or if instead via backcrossing is referring to the cross between EE1660700 and PB60045-22. These two different schemes would produce genetically distinct offspring and therefore “via backcrossing” introduces more than one scope for the term “CL2042637”, rendering the claim indefinite.
Additionally, given that the instantly claimed plant is generated by a backcrossing method it is critical to know which parent is the recurrent parent and which is the donor parent. This is because in this scheme each parent contributes a substantially distinct percentage of the genetics of the progeny line. This is because as made clear in applicant’s specification, in backcrossing methods a single genetic allele or loci is transferred into a desirable homozygous recurrent parent (Instant Specification, Page 3, Lines 24-25). Therefore knowing which parent is the recurrent parent and which is the donor parent is imperative in understanding the genetic characteristics of the instant variety. Without this the genetic characteristics of the instant variety are not clear and therefore the scope of the claim is not clear.
Given the language of the pedigree section of the amended specification, upon first glance it appears that variety CW1660237 would be the recurrent parent in a backcrossing scheme with the progeny of a cross between varieties EE1660700/15 PB60045-22 being the donor parent. However, there are several pieces of evidence that suggest this may not be the case.
Variety CW1660237 has the following plant morphological characteristics: purple flowers, gray pubescence, tan pod color and buff hilum color, see table 17 on page 24 of US 2019/0289808 A1. Further, table 17 shows that variety CW1660237 is chloride sensitive, possesses the MON 87708, MON 89788 and the Rps1c Phytophthora root rot resistance allele as well as a relative maturity of 0.0007.
In contrast the instantly claimed variety appears morphologically distinct. While only three of the four color traits appear to have been reported, from the information in table 1 of the instant specification the instantly claimed variety appears to have purple flowers, light brown pubescence and brown pod color. Further, this variety is chloride sensitive, possesses the MON87708, MON89788, A5547-127 herbicide transgenes, the Rps1c phytophthora gene and has a relative maturity of 0.040.
Given this information the instant variety differs from the parent variety in at least pubescence color, pod color, relative maturity and the presence of the A5547-127 herbicide transgene and may differ in the other unreported color related trait. Backcross breeding is used to introduce a single trait, see Instant Specification, Page 3, Lines 24-25. Given these differences in at least three different mendelian traits it does not appear that Variety CW1660237 is the recurrent parent used in a backcrossing scheme to produce the instant variety as the two varieties would differ by only a single trait rather than the at least three described in the analysis above.
If the instant variety was produced using a backcrossing method with Variety CW1660237 as the recurrent parent why would the progeny of a cross be used to donate the desired added trait? The time and effort of a crossing step could be saved by simply using whichever parent (EE1660700 or 15 PB60045-22) of that progeny carried the trait of interest.
If this is not the case, it remains unclear whether the backcrossing step was used to produce the progeny plant which was crossed with CW1660237 or if CW1660237 was crossed to the progeny plant using backcrossing, with CW1660237 as the donor parent. In the latter scenario, given that the genetics of the grandparental lines are not described nor known in the art the specific genetics of the instantly claimed variety are similarly unclear.
As such despite the newly added pedigree section of the specification the specific genetics of the instantly claimed cultivar are not clear and the claims are rejected as indefinite.
Dependent claims are also rejected because they fail to overcome the deficiencies of parent claims.
The office suggests that answering the following two questions may overcome the rejections of record:
Is the backcrossing breeding method the overall method performed by an initial cross between CW1660237 and the progeny of the cross between EE1660700 and 15 PB60045-22 or is it instead the method to produce the progeny of EE1660700 and 15 PB60045-22?
Regardless of which pair are crossed in the backcrossing scheme which parent is the recurrent parent and which is the donor parent?
What trait is the backcrossing scheme used to transfer?
Response to Applicant Arguments – Written Description
Applicant’s arguments dated 03/02/2026 have been fully considered and are not found to be persuasive. Applicant’s arguments are summarized and addressed below.
Applicant states that the specification has been amended to provide additional information regarding the breeding history of the claimed soybean line and urges that this overcomes the written description rejections of record.
In response to these arguments the office notes that providing this additional information on the breeding history provides more description of the genetic characteristics of the claimed variety, however these arguments are not found to be persuasive because the pedigree provided in the amended specification is unclear, see indefiniteness rejection above, and insufficient to describe the genetic characteristics of the instantly claimed soybean line.
As noted in the indefiniteness rejections presented above, the pedigree provided in applicants amended specification does not make clear the parents of the instant variety nor does it make clear the steps taken to produce the instant variety and therefore the specific genetics of the instant variety have not been adequately described.
Specifically, it is not clear whether “via backcrossing” at the end of the pedigree section refers to the production of CL2042637 by backcrossing CW1660237 and the progeny of the cross between EE1660700/15 PB60045-22 or if instead via backcrossing is referring to the cross between EE1660700 and PB60045-22. These two different schemes would produce genetically distinct offspring and therefore “via backcrossing” introduces more than one scope for the term “CL2042637”.
Additionally, given that the instantly claimed plant is generated by a backcrossing method it is critical to know which parent is the recurrent parent and which is the donor parent. This is because in this scheme each parent contributes a substantially distinct percentage of the genetics of the progeny line. This is made clear in applicant’s specification which states that in backcrossing methods a single genetic allele or loci is transferred into a desirable homozygous recurrent parent (Instant Specification, Page 3, Lines 24-25). Therefore knowing which parent is the recurrent parent and which is the donor parent is imperative in understanding the genetic characteristics of the instant variety. Without this the genetic characteristics of the instant variety are not clear and therefore the specification lacks adequate description of the instant variety.
As such applicant’s amendments do not overcome the rejections of record and applicant’s arguments are not found to be persuasive and the rejections of record are maintained.
Claim Rejections - 35 USC § 112 (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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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.
Due to Applicant’s amendment of the claims, the rejection is modified from the rejection as set forth in the Office action mailed December 08, 2025 as applied to claims 1-17. Applicant’s arguments filed on March 02, 2026 have been fully considered but they are not persuasive, see above.
Lack of Breeding History
Claims 1-17 remain 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 instant Specification fails to satisfy the written description requirement of 35 U.S. Code § 112(a) because there is not a complete breeding history which makes clear the starting material and breeding steps used to produce the instant variety, included in the disclosure.
Specifically, in the instant application, applicant has provided a limited description of the pedigree and a description of plant traits as seen in the specification. The instant application is incomplete as to the complete breeding history used to produce the claimed plant variety.
The breeding history is incomplete because the specific pedigree and breeding history of the claimed plant line is not known in the art and a complete and clear breeding history is not provided in the Specification, see indefiniteness rejection above. It is not clear whether soybean variety CL2042637 has any other synonyms or tradenames, nor what is the source of this plant line or the lines used to produce it. The breeding history must be clarified regarding synonyms, tradenames and the sources thereof as well as the specific steps taken to produce the instantly claimed line.
To ensure clarity specific deficiencies in the pedigree provided by applicant are identified and analyzed as follows. Given the language used in the pedigree section of the amended specification, it is not clear whether “via backcrossing” refers to the production of CL2042637 by backcrossing CW1660237 and the progeny of the cross between EE1660700/15 PB60045-22 or if instead via backcrossing is referring to the cross between EE1660700 and PB60045-22. These two different schemes would produce genetically distinct. Additionally, given that the instantly claimed plant is generated by a backcrossing method it is critical to know which parent is the recurrent parent and which is the donor parent. This is because in this scheme each parent contributes a substantially distinct percentage of the genetics of the progeny line. This is made clear in applicant’s specification which states that in backcrossing methods a single genetic allele or loci is transferred into a desirable homozygous recurrent parent (Instant Specification, Page 3, Lines 24-25). Therefore knowing which parent is the recurrent parent and which is the donor parent is imperative in understanding the genetic characteristics of the instant variety. Without this the genetic characteristics of the instant variety are not clear and therefore the specification lacks adequate description of the instant variety.
Applicant claims a new plant variety and methods of producing the variety. This introduces a question of fact: what is an adequate written description of a plant variety.
In searching for an answer to the above question of fact, a search of the relevant art provided answers on what constitutes written description of a plant variety. A plant variety is defined by both its genetics (which are described in the breeding history) and its traits. The following are presented as a review of the state of the art with respect to the question of fact presented above; what is written description of a plant. The following is not presented as a legal basis for the rejection.
In plant breeding a breeding history in considered critical in describing a variety and assessing the intellectual property rights of a plant. 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, 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 lacking 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 a specific and complete breeding history, the public will not be able to fully resolve questions of infringement. Since the breeding history, including the exact 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/drawings to provide a complete and clear 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 (Emphasis added). 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)(Emphasis added).
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).
Of interest the MPEP notes that in addition to demonstrating that the applicant is in possession of the claimed invention that the disclosure should have several other characteristics as follows:
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 case the description of the genetics of the variety provided in the specification is insufficient to permit verification that the deposited biological material is in fact that disclosed and the trait table is insufficient to distinguish one claimed variety from another claimed variety, see double patenting rejection below.
As such claims 1-17 remain rejected as lacking adequate written description.
Response to Applicant Arguments – Double Patenting
In response to applicant’s amendments to the specification and arguments dated March 2, 2026 the double patenting rejections of record are withdrawn.
Prior Art
Given the information provided in the instant disclosure, particularly the lack of a specific breeding history including the exact parents of the instant variety and the specific breeding steps used to produce it, including identification of the recurrent and donor parents in any backcrossing steps it is not possible to determine the closest prior art. These pieces of information are critical in describing the genetic characteristics of the claimed cultivar and without them the closest art cannot be identified.
However, other information can be used to describe certain characteristics of a claimed plant variety or cultivar. One such piece of information is the transgenes carried by a specific cultivar. In the instant application the claimed soybean variety CL2042637 contains the MON 87708, MON 89788 and A5547-127 herbicide resistance loci, the Rag1_S Aphid resistance gene and the Rps1C phytophthora gene.
At the time of the earliest filing date there does not appear to be any soybean cultivars that are known to contain those three specific transgenes.
Given this the instantly claimed variety is provisionally deemed to be free of the prior art.
Conclusion
No claims are allowed.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN JAMES SULLIVAN whose telephone number is (571)272-0561. The examiner can normally be reached 7:30 to 5:00.
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, 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.
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//BRIAN JAMES SULLIVAN/ Examiner, Art Unit 1663
/Amjad Abraham/SPE, Art Unit 1663