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 .
This is a Final Office Action in response to amendment filed on November 24, 2025. Claim 11 is amended. Claims 1-22 remain pending and are examined on their merit herein.
Response to Amendment
The rejection of claims 11-15 under 35 U.S.C. 112(a) regarding the written description requirement is withdrawn in view of amendment to the claims.
The rejection of claims 1-22 under 35 U.S.C. § l 12(a) regarding the enablement requirement related to biological deposit is withdrawn in view Applicant’s assurance of the compliance.
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.
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.
This rejection is maintained for the reasons of record, because the remarks by Applicants submitted on November 24, 2025, have been fully considered but not deemed persuasive. See below for the response to Applicant's remarks at the end of this rejection.
Written Description regarding Breeding History
Claims 1-22 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 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.
As cited above, the statute of first paragraph of 35 U.S.C. 112(a) requires that the “specification shall contain a written description of the invention, and of the manner and process of making and using it”.
Further,
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 the breeding history for the instantly claimed plant variety. Specifically, in claim 1, applicant claims a new lettuce variety SVLD0093, a representative sample of seed of said variety SVLD0093 has been deposited under NCMA Accession Number 202212295. 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 (e.g., Tables 1-3). The instant application is silent or incomplete as to the breeding history used to produce the claimed plant variety. The Specification has not disclosed the identity of the parental lines and the breeding method and history for obtaining the claimed 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” (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 Remarks:
Applicant argued that the Action's assertion that§ l 12(a) requires disclosure of a "complete breeding history" is legally and factually incorrect. Applicant also argued that the Action “rests on standards from Plant Patent practice and PVP/UPOV regimes that are inappropriate to utility patent examination under§ 112.”
These arguments are not persuasive.
The instant application fails to provide a complete written description of the claimed invention. A plant variety is defined by both its genetics (breeding history) and its traits. Applicant has provided a description of the plant traits as seen in the specification. Applicant has provided, in the Transmittal Letter of 4/12/2024, the breeding method and parents for the instantly claimed plant variety; and has indicated that donor parent, line CHD-MQ14-0919GMS, is a nonpublic proprietary line. However, these information has not been incorporated into the Specification as provided. The instant application is thus incomplete as to the breeding history used to produce the claimed plant variety. Bringing that information into the Specification would, however, overcome this rejection.
Applicant urges that the written description requirement is provided by the deposit, such that they do not have to provide a breeding history, citing Ex Parte C, Enzo, Inari, in re Lundak, and a letter from the USPTO director (response pg 6-17).
This not found persuasive.
Applicant has other plants with nearly identical traits. Trait similarity and the lack of explanation of the value of the instant soybean makes the analysis on the breeding history vital.
While Applicant urges that the deposit provides all the description necessary to meet the requirements of written description, but that is not the case. The deposit is necessary but not sufficient.
If a deposit were all that is needed, then a phenotype table would not be necessary. However, a plant described only by a deposit cannot be examined; the patent office does not have the facilities to grow up the claimed plant and all soybean plants in the art to compare their phenotypes and do a genetic analysis on the claimed plant and plants with the same phenotype or a phenotype that makes obvious the claimed plant to see if the claimed plant is genetically related to the prior art plant.
There are over 6000 patents on soybean varieties and thousands of patent applications that have been published but not yet issued. If these 6000+ soybean plants were only described by deposit, one needing to know the phenotype and genotype of any or all of the plants, as would a soybean breeder, would need to grow each up to evaluate phenotype and perform a genetic analysis to evaluate genotype. Performing a phenotypic and genetic analysis on 6000+ soybean plants would be an undue burden on each soybean breeder. It would also be a burden on the patent holder, as the deposited seed would rapidly be depleted and would need frequent replacement. Lastly, as deposits do not need to be maintained into perpetuity, the genetic information provided therein would no longer be available if there is a 5-year gap after the last request, shutting later breeders out of the information therein. Words describing the phenotype and parents of a soybean plant do not shut future inventors out of a description of a prior art soybean plant.
Similarly, merely providing in the specification arbitrary names for the parents of a soybean plant and hiding the publicly known names for them is not useful to someone that is not the Applicant, and does not describe an invention to the examiner or the public.
Phenotypic and parental (genetic) information and a deposit are all necessary parts of the description of a soybean plant.
Regarding 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) are critical.
(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. (emphasis added)
The strict interpretation of the law is clear: Applicant must provide in the specification a written description of the invention. The only question is what an “adequate written description” is. This is a fact-based inquiry done by the factfinder (i.e., the examiner) when analyzing the nature of the instant invention.
The references cited in the rejection are evidence regarding that question of fact regarding what is considered when describing plants. They are not cited for legal analysis. The references cited, including USDA and UPOV, establish that in the plant variety art, a breeding history is part of the description of a plant variety.
Applicant has not provided evidence saying that in the plant variety art the breeding history is not considered part of the description of a plant variety. Applicant has not rebutted the evidence provided in the rejection.
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 this 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 findings to clarify the law. They are solely to clarify the finding of fact, i.e., 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 for a plant variety.
Lastly, 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).
If Applicant has issues with the guidance in the MPEP, arguing with the examiner applying that guidance is not the solution, as examiners have no role the decision to include that guidance in the MPEP.
To overcome this rejection, Applicant must amend the specification to identify any and all other potential names for all parental lines utilized in the development of the instant variety.
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).
Conclusion
No claims are allowed.
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.
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WEIHUA . FAN
Primary Examiner
Art Unit 1663
/WEIHUA FAN/Primary Examiner, Art Unit 1663