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 .
Claims
Claims 1-20 are pending
Claims 13 and 18 are currently amended
This action is a final office action in response to applicant’s remarks and amendments on August 28, 2025 responding to the non-final office action on May 30, 2025.
Previous office action has the previous grounds of rejection:
(1) 35 USC112b on claims 1-20
Missing accession Number
Application of definition of “soybean plant” in Paragraph 0195 of the specification to the instant claims.
(2) 35 USC 112 (enablement)
Non-perfected deposit
(3) 35 USC 112 (written description)
Application of definition of “soybean plant” in Paragraph 0195 of the specification to the instant claims.
Incomplete breeding history
(4) Double Patenting rejections
Examiner withdraws the rejection under 35 USC 112 (Enablement) as applicant has stated they will comply with the enablement requirement under the Budapest treaty and that all restrictions will be irrevocably removed upon granting of the patent. See applicant’s response below.
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Examiner withdraws the rejections of 35 USC112 a and b (in regard to the definition of plant part in paragraph 0195). Applicant has disclaimed the application of the definition to the instant claims and clarified that the skilled artisan would interpret the claimed variety narrowly and not applied the expanded definition to the deposited and claimed variety. The office accepts applicant’s clarifications as to the claim scope.
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The remaining rejections are maintained and reproduced below.
35 USC 112b (missing accession number), 35 USC 112A (Incomplete Breeding History) and double patenting rejections.
Response to Arguments
Applicant's arguments filed on August 28, 2025, have been fully considered but they are not persuasive. Because the arguments on the double patenting and written description are intertwined the office will address them simultaneously.
Applicant Argument
Applicant argues that they do not need to provide a complete breeding history because several court and board cases reference that the presence of a deposit satisfies the written description requirement (see snippet from applicant’s argument below).
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Basically, applicant argues that the public can access their deposit and perform a molecular marker analysis and that would provide structural (genetic) characteristics to distinguish the instant plant with other plants in the public domain.
Examiner response
First, addressing applicant’s arguments that anyone can do a genetic marker analysis using their deposit if they need additional information.
This is misleading. A review of claim 18 and 19 shows that applicant is asking the office to preclude anyone from performing a marker analysis. Applicant needs to explain how a marker analysis can be conducted if they have claims preventing the genotyping of the plant. If someone, cannot genotype the plant they cannot do a marker analysis as requested by the applicant. If a marker analysis cannot be done, then applicant’s assertion that written description can be satisfied by way of the deposit is misleading. Applicants claim 18 and 19 in effect would make the public an infringer to genotype the instant variety as a means to distinguish their plant from the instant variety.
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Moreover, applicant states you can use a genetic marker analysis to distinguish the instant variety from other plants (see below). If this was so straight forward, why did the applicant not provide marker information to distinguish the plants from those plants cited in the double patenting rejections. Applicant is in the best position to but applicant’s theory to practice as they own the copending applications and the instant variety and likely have markers available. Applicant’s failure to provide this information is evidence that it is not practical to do a marker analysis to distinguish plants from one another.
Second, the office’s written description position on the incomplete breeding history is boosted by the fact that applicant has many other plants with nearly identical traits. The trait similarity and the lack of explanation of the value of the instant soybean makes the analysis on the breeding history more important. 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 office needs more specific breeding history primarily due to the phenotypic similarity between the instant soybean and the other cases listed in the ODP rejections.
In addressing, applicants’ arguments on the legal basis of the written description rejection and the court’s/board’s interpretations. The best starting point for a written description analysis is the law itself. The first 10 words of 35 USC 112 (a) is very important.
“The specification shall contain a written description of the invention.”
The strict interpretation of the law is clear. Applicant must provide in the specification a written description. The only question is what is an “adequate written description”. This is a fact-based inquiry done by the factfinder (the examiner) when analyzing the nature of the instant invention.
The office has made a finding of fact that for the instant variety the minimum description is the combination of the phenotype and genotype (breeding history). To support the finding of fact, the office has cited other plant related intellectual property organizations and relevant court cases dealing with plant varieties in which both the phenotype and genotype are analyzed. The office did not cite these finding to clarify the law. They are solely to clarify the finding of fact (that is what is an adequate written description for the instant plant variety). Applicant’s arguments ask the office to not consider the actual statute and base our decision solely on statements from court/board cases that do not directly decide what an adequate written description is a for a plant variety.
In the rejections below: the office provided examples of other soybean plants that have a nearly identical phenotype to the soybean plant of the instant variety. These plants are all owned by the applicant. The office also cited statements by the applicant in copending cases which they acknowledge that that soybean seeds are susceptible to natural variation caused by genetics and the environment. (See double patenting rejections below). Because of the phenotypic similarity, the office needed to analyze the genotype more carefully. A review of the genotype provided only arbitrary/proprietary line information that is not useful to someone that is not the applicant. These line names with a general allegation of distinctness do not allow for the office to have a full understanding of the instant variety.
Applicant also argues that the parental lines of the instant variety are genotypically distinct from the lines used to develop the instant variety.
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Applicant’s argument is insufficient
First, applicant has not stated whether the parental line designations are in the public domain, nor the breeding strategy used.
Second, applicant has not defined the parameters for their statement that the parents are genotypically distinct. For example, if a marker profile where run on applicant’s deposit not all the seeds would have the same marker profile. Based on that analysis, the seeds of the instant variety would be genetically distinct from one another.
Third, Examiner did not make a statutory double patenting rejection and made an obvious type double patenting rejection. Examiner did not allege that the plants were identical. Stating they are distinct is not on point to the rejection at hand. Examiner acknowledges that there are differences but stated that in the field those differences are often expected and obvious depending on environmental concerns and breeding selection. This is why further information on the breeding history is necessary.
Finally, we will use the instant application and 18370749 (in double patenting rejection) as an example of why more information is needed on the breeding history.
Let us look at the similarity between the two:
The qualitative traits are nearly identical except for the hilum color. (See tables below). This difference could be a result of the donor plant, environmental differences, or segregation.
The breeding history is identical:
Initial crosses were both made in Adel, Iowa
The fact that the F1 and F2 population were grown in Guyana in the same years 2018-2019
The F3 was bulked and grown in the Midwest in 2019 and advanced using single seed descent.
Plants were grown in Argentina in 2019-2020
Yield trials were in 2020 and the same F5 generation was pulled.
Then in 2020-2021 they were moved back to Argentina.
Then in 2021-2022 they were selected.
Applicant needs to explain more information about the starting materials and the initial generations to allow for a clear determination of distinctness. A statement should be made about the public availability of the starting materials.
Applicant needs to explain the connection between these starting materials outside of the fact that they are distinct. Do they share parents/genetics in common.
Undefined line designations with a general statement about them being distinct is insufficient.
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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 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.
Claims 1-20 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 1-20 are indefinite in that the due to the blank lines present in claims 1, 11, and 13. The blank lines are intended as placeholders for the accession number which is not yet presented by the applicant to the office. Without an accession number the blank lines leave the claims indefinite as it is unknown which deposit will be linked to the instant soybean (28030716).
The failure to provide a deposit also renders the recitation of the soybean cultivar name “278030716” as indefinite as the cultivar has no meaning without its linkage to a deposit.
Claim Rejections - 35 USC § 112 (Missing Breeding History)
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.
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.
MPEP 2163 section (I) states “"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.” In this case, the nature of the invention claimed is the creation of a new soybean variety “28030716”. It is well established that a plant is defined by its phenotype (traits) and its genotype (breeding history). Applicant has not provided detailed information on the genotype of “28030716” in the specification and thus fails to provide an adequate written description of the claimed invention. While the specification does provide the breeding history, material information vital to an adequate written description is missing, the missing information includes: (1) Whether 15CV304418-26 is a publicly available line and whether it is known by other names and (2) what trait is being donated by the 16EN309122-01 and whether 16EN309122-01 is a public line (with a listing of alternate names). Applicants should amend the specification to incorporate the omitted breeding history information.
The reason that the breeding history is insufficient is evidenced in the double patenting rejection below. Both the instant application and copending application 18370749 have an identical breeding history except for different names for the starting materials. Everything is identical including the backcross method, breeding steps, location where the plants were grown and even the traits are nearly identical. Because there is no meaning to the line designations the breeding history is insufficient to differentiate the applications from one another.
Additionally, 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).
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).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Examiner Notes: As stated above, applicant needs to submit further information as to the breeding history of the instant application. The double patenting rejections below are made due to the lack of information as to the recurrent parent and donor plant used in applicant’s breeding history. The rejections below are the examiners best efforts to conduct an obviousness analysis without complete breeding history information. Applicant should submit for the record any plant that would be considered a sibling or uses the same/similar recurrent parent in the breeding process of another plant.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 12,150,426. Although the claims at issue are not identical, they are not patentably distinct from each other because the traits are nearly identical to one another.
The trait table of the instant application is nearly identical with that of USP 12,150,426. The only difference is hilum color which is segregating in one (Black and Brown) and just Brown in the other. Both plants were formed using a backcrossing breeding strategy, however there is insufficient information to determine whether the plants are substantially different from one another. The difference can be attributable to the donor plant, environmental conditions, and segregation. In fact, applicant admits that soybean seeds are susceptible to natural variation caused by genetics and the environment. (See applicant’s specification paragraph 0072). Because of the similarity and minimal differences it is expected that the patent and applications are obvious variants from one another.
Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18370749.
The copending applications have nearly identical trait tables and breeding histories (only difference is parental names). The only differences seem be variation in the Hilum (black vs. brown) and Pod Wall color (Tan vs. Brown) which can be attributable to the donor plant, environmental conditions, and segregation. In fact, applicant admits that soybean seeds are susceptible to natural variation caused by genetics and the environment. (See applicant’s specification paragraph 0072). Because of the similarity and minimal differences it is expected that the copending applications are obvious variants from one another.
Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18370731.
The copending applications have nearly identical trait tables and breeding histories (Similar breeding strategies with only differences in internal line designations). The only differences seem be variation in the Pod Wall color (Tan vs. Brown) which can be attributable to the donor plant, environmental conditions, and segregation. In fact, applicant admits that soybean seeds are susceptible to natural variation caused by genetics and the environment. (See applicant’s specification paragraph 0072). Because of the similarity and minimal differences it is expected that the copending applications are obvious variants from one another.
Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18370746.
The copending applications have nearly identical trait tables and breeding histories (only difference is parental names). The only differences seem be variation in the Hilum (black vs. brown) and Pod Wall color (Tan vs. Brown) which can be attributable to the donor plant, environmental conditions, and segregation. In fact, applicant admits that soybean seeds are susceptible to natural variation caused by genetics and the environment. (See applicant’s specification paragraph 0072). Because of the similarity and minimal differences it is expected that the copending applications are obvious variants from one another.
This is a provisional nonstatutory double patenting rejection.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMJAD A ABRAHAM whose telephone number is (571)270-7058. The examiner can normally be reached Mon-Friday 830 AM to 500 PM.
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 A Abraham can be reached at 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.
AMJAD A. ABRAHAM
SPE AU 1663
Art Unit 1663
/Amjad Abraham/SPE, Art Unit 1663