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 .
DETAILED ACTION
1. The Office acknowledges the receipt of Applicant’s amendment filed December 16, 2025. Claims 1-17 are pending and are examined.
All previous rejections not set forth below have been withdrawn.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
This action is made FINAL.
Specification
2. The disclosure is objected to because of the following:
The deposit information on page 41 is incomplete. Compliance with the deposit requirements may be held in abeyance until allowability is indicated.
Claim Objections
3. Claims 1-17 are objected to because of the following:
In claim 1, line 2, “line” should be inserted before “CL2044163” for language consistency.
In claim 6(b), first line, “a progeny” should be amended to “the progeny”.
In claim 11, line 3, “of soybean line” should be inserted before “CL2044163” for language consistency.
In claim 13, line 3, “single” should be inserted before “transgene” for language consistency.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
4. 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.
In claim 1, the deposit information is incomplete. Because line CL2044163 is not an art-recognized term, the metes and bounds of line CL2044163 are unclear absent a deposit recitation. Compliance with the deposit requirements may be held in abeyance until allowability is indicated.
In claim 3, it is unclear how the transformed plant differs from the plant of claim 1, because the transformed plant comprises all the physiological and morphological characteristics of soybean line CL2044163. See also claim 4, directed to a seed of the soybean plant of claim 3.
In claim 14(d), it is unclear what plant the progeny plants from step (c) are crossed with. See also step (e). Applicant’s amendments do not address this rejection because it is unclear what the progeny plants from step (c) or (d) are crossed with: another progeny from step (c) or (d), or a plant of line CL2044163?
Clarification and/or correction is required.
Claim Rejections - 35 USC § 112(a)
5. Claims 1-17 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Since the seed claimed is essential to the claimed invention, it must be obtainable by a reproducible method set forth in the specification or otherwise be readily available to the public. If a seed is not so obtainable or available, a deposit thereof may satisfy the requirements of 35 U.S.C. 112. The specification does not disclose a reproducible process to obtain the exact same seed in each occurrence and it is not apparent if such a seed is readily available to the public. If the deposit of the seed is made under the terms of the Budapest Treaty, then an affidavit or declaration by the Applicant, or a statement by an attorney of record over his or her signature and registration number, stating the seed have been deposited under the Budapest Treaty and that the seed will be irrevocably, and without restriction or condition, released to the public upon the issuance of a patent would satisfy the deposit requirement made herein. A minimum deposit of 625 seeds is considered sufficient in the ordinary case to assure availability through the period for which a deposit must be maintained.
If the deposit has not been made under the Budapest Treaty, then in order to certify that the deposit meets the criteria set forth in 37 CFR 1.801 -1.809, Applicant may provide assurance of compliance by an affidavit or declaration, or by a statement by an attorney of record over his or her signature and registration number showing that
(a) during the pendency of the application, access to the invention will be afforded to the Commissioner upon request;
(b) all restrictions upon availability to the public will be irrevocably removed upon granting of the patent;
(c) the deposit will be maintained in a public depository for a period of 30 years or 5 years after the last request or for the enforceable life of the patent, whichever is longer;
(d) the viability of the biological material at the time of deposit will be tested (see 37 CFR 1.807); and
(e) the deposit will be replaced if it should ever become unviable.
The specification and claims must be amended to include the deposit accession number. Compliance with the deposit requirement may be held in abeyance until the application is otherwise in condition for an allowance. Evidence of an accepted deposit is requested.
Applicant’s Traversals
Applicant submits that a deposit is in progress and requests that the deposit requirements be held in abeyance pending completion of the deposit and viability testing.
Response to Applicant’s Traversals
Accordingly, the rejection is maintained.
6. Claims 1-17 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.
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) further 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 soybean plant line. A plant line or 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 shown in the specification. The instant application is silent or 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” (See “Applying for a Plant Variety Certificate of Protection”, USDA, https://www.ams.usda.gov/services/pv po/application-help/apply, downloaded 05/01/2023, (previously cited)). 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 (UPOV, Explanatory Notes on Essentially Derived Varieties Under the 1991 Act of the UPOV Convention, April 6, 2017, See UPOV EDV Explanatory Notes 14 and 30 (previously cited)). 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 the plants are 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) (previously cited) and Ex Parte McGowen Board Decision in Application 14/996,093, decided June 15, 2020 (previously cited)). 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 et al. (Plant Physiology, Feb. 2011, Vol. 155, pp. 645-655 (previously cited)) teaches that the assumption that elite cultivars are composed of relatively homogenous genetic pools is false. (p. 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 (p. 645, right column and p. 646, left column). In addition to genetic variation, environmental variation may lead to phenotypic variation within a cultivar. (Großkinsky et al., J. Exp. Bot., Vol. 66, No. 11, pp. 5429-5440, 2015 (previously cited), p. 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 to adequately 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, line 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 and all other potential names of the instant variety. 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 should identify the breeding method used, such as single seed descent, bulk method, backcross method, etc., and the filial generation in which the instant plant was chosen. Information pertaining to the homozygosity or heterozygosity of the parents as well as the instant plant should be set forth.
Applicant is 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). If there any patent applications or patents in which sibs, progenies or parents of the instant plant are claimed, the serial numbers and names of the sibs, progenies or parents should be disclosed. This information can be submitted in an Information Disclosure Statement 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).
Applicant’s disclosure is insufficient because it does not address all the issues set forth above, and a specification devoid of a breeding history hampers the public’s ability to fully resolve questions of infringement. 35 USC 112(a) clearly states “The specification (emphasis added) shall contain a written description of the invention”.
Correction is required.
Applicant’s Traversals
Applicant traverses primarily the following. (1) Communication of January 14, 2025 from Acting Undersecretary of Commerce for Intellectual Property and Acting Director of the USPTO concludes deposits of material are sufficient to satisfy §112(a) (Appendix A). (2) The written description requirement requires demonstrating possession of the claimed invention, not facilitating procedures or prior art searches. (3) A deposit under the terms of the Budapest Treaty satisfies the written description requirement. (4) Equating PVP or UPOV requirements to US utility patent requirements is improper. (5) By citing MPEP 1605, the Office is conflating requirements for plant patents with those of utility patents on plants. (6) Ex parte C supports Applicant’s position, which states that “While the examiner may want to possess additional information regarding the inventive process, in this case the inheritable characteristics of parent species of plants and the particular procedure used to select for the claimed plant, in order to carry out a thorough examination, there is nothing in the statute which commands its inclusion in the specification.” (7) The proper remedy for obtaining information to facilitate examination is a Rule 105 request, which allows the examiner to request information beyond what is statutorily required for patentability (In Star Fruits S.N.C. v United States).
Response to Applicant’s traversals
Applicant’s traversals have been considered but are deemed unpersuasive for the following reasons.
With regard to traversal (1), Appendix A has not been submitted. Moreover, The statute 35 USC 112(a) encompasses both deposit requirements and written description requirements. The communication of January 14, 2025 from the Acting Undersecretary of Commerce does not address the requirement of an adequate written description in the Specification as specified under the statute.
With regard to traversal (2), the purpose of the written description requirement is not to facilitate procedures or prior art searches but to comply with the statute under 35 USC 112(a) which states “The specification (emphasis added) shall contain a written description of the invention”. With regard to traversal (3), a deposit alone does not satisfy the written description requirement. If this were true, then Applicant need not provide any description whatsoever for line CL2044163 in the Specification. MPEP 2163(I) states “a showing of possession alone does not cure the lack of a written description”, citing Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956, 969-70, 63 USPQ2d 1609, 1617 (Fed. Cir. 2002). “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." (Quoting the Deposit of Biological Materials for Patent Purposes, Final Rule, 54 Fed. Reg. 34,864 (August 22, 1989) at 34,880).
With regard to traversals (4), (5) and (6), the above cited documents were not relied upon to determine the requirements for a plant utility application or for legal precedence. They were considered to determine the state of the art as to what is adequate description for a plant variety. 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 (USDA, UPOV) and relevant court cases (Ex parte C, Ex Parte McGowen) dealing with plant varieties in which both the phenotype and genotype were analyzed. For Plant Patents, MPEP 1605 states that a complete detailed description of a plant includes “the origin or parentage”. Haun et al. and Großkinsky et al. were cited to show that a trait table is insufficient to differentiate varieties by itself, because intracultivar heterogeneity exists in crop species, and environmental variation may lead to phenotypic variation within a cultivar. The citations above are not referenced for legal authority. The legal authority relied by the examiner is the 35 USC 112(a) statute. The citations are presented to support the finding of fact that a breeding history is necessary for the adequate description of a plant variety. In evaluating written description, the threshold question is: what is an adequate written description? This is question of fact that is evaluated by the factfinder (examiner). MPEP 2163.04 clearly states that “The inquiry into whether the description requirement is met must be determined on a case-by-case basis and is a question of fact. In re Wertheim, 541 F.2d 257, 262, 191 USPQ 90, 96 (CCPA 1976).” The facts are as follows. The specification discloses phenotypic traits of CL2044163 in Table 1. The claims indicate seeds representative of line CL2044163 are deposited. However, the claims are not directed to the deposited seeds or plants grown therefrom. Neither the Specification nor the claims indicate that the claimed seed is genetically identical to the deposited seeds. When two inbred parents are crossed, one skilled in the art would reasonably expect to obtain a population of progeny plants that shares most of the phenotypic characteristics but are not necessarily genetically identical due to naturally-occurring genetic and environmental factors. Additionally, page 20, lines 17-19, of the specification acknowledges that any characteristic may vary due to environment (phenotypic variations) or during the course of repeated sexual reproduction (genotypic variations). Thus, the recitation of “CL2044163” in the claims is understood by the Office to encompass a genus of seeds/plants that is not genotypically or phenotypically identical to the deposit. Therefore, the disclosed characteristics in the specification and the deposit are not sufficient for written description because the claimed genus of seeds and plants are not required to be genotypically and phenotypically identical to the deposited seeds or have all the characteristics disclosed in the specification. The prior art teaches numerous soybean varieties that share many or most of the commonly disclosed phenotypic traits. Due to these phenotypic similarities, the Office needs more specific breeding history to distinguish the claimed genus of plants of CL2044163 from other plants. Thus, the question is not whether one skilled in the art can distinguish the claimed plant from other plants, but whether one skilled in the art can distinguish the genus of claimed plants from other plants. The disclosure of the parents, i.e., breeding history, used to produce the claimed genus is an essential component for determining the patentability of the claimed genus.
With regard to traversal (7), 35 USC 112(a) clearly states “The specification (emphasis added) 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. A Trade Secret submission as provided under 37 CFR 1.105 cannot satisfy this statutory requirement because said submission is not part of the specification. Contrary to Applicant’s traversals, the requested information is not beyond what is statutorily required for patentability. An adequate written description precludes the issuance of a patent that would otherwise issue due to Applicant’s omission of critical information from the Specification.
It should be noted that Applicant does not provide marker information to distinguish the claimed genus of plants from other plants when Applicant is in the best position to do so. Polymorphisms exist within the genus of plants claimed. 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.
Accordingly, the rejection is maintained.
Conclusion
7. No claim is allowed.
8. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
9. Any inquiry concerning this communication or earlier communications from the examiner should be directed to PHUONG T BUI whose telephone number is (571)272-0793. The examiner can normally be reached M-F 8am-5pm.
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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/PHUONG T BUI/Primary Examiner, Art Unit 1663
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