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 .
The affidavit filed by Liping Diao on 4/10/2026 is acknowledged and has been fully considered.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.
Status of claims
Applicant’s response filed 4/21/2026 has been entered.
Claim set of 4/10/2026 is the latest claim set.
Claims 9-10, 15 had/have been canceled.
In summary, claims 1-8, 11-14, 16-20 are pending and examined in this office action.
Definition of “essentially all the physiological and morphological characteristics”
According to the specification, in the Definitions ([0066]), “Essentially all the physiological and morphological characteristics. A plant having all the physiological and morphological characteristics of the hybrid or cultivar, except for the characteristics derived from the converted gene”.
Claim Rejections - 35 USC § 112
Lacking 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.
Claims 1-8, 11-14, 16-20 are rejected under 35 U.S.C. 112(a), 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The rejection is made because the specification fails to disclose the breeding history and parent lines of the instant rice RT23L401.
35 USC 112 (a) states that “The specification shall contain a written description of the invention”. 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 instant invention is a new rice line RT23L401. Accordingly, the examiner will evaluate what is an adequate written description for new tomato lines. In reviewing this question of fact, the examiner analyzed how plant lines are evaluated in the public domain. The review concluded that generally the minimum requirements for an adequate description of a new plant variety has a trait table and genetic information (via a breeding history). In reviewing applicant’s specification, the applicant has only provided a morphological characteristics of rice RT23L401 ([0033]-[0035], Table 1), serving as a phenotypic description. However, there is no accompanying breeding history in the specification.
The examiner noticed that in the amended specification of 9/12/2025 ([0205]-[0208]), “Hybrid Rice RT23L401 was bred by crossing a female parental line A ("Parent A") and male parental line B ("Parent B"). Hybrid Rice RT23L401 has essentially all physiological and morphological characteristics of Parent A and Parent B as listed in Table 1. Hybrid Rice RT23L401 is the filial generation F1 product of crossing parental lines A and B. Parental lines A and B are homozygous. They have been self-pollinated through a number of generations and are determined to be uniform and stable. “A” and “B” are not real parental lines, and do not satisfy written description, and are not searchable for prior art and/or double patenting.
Because the specification lacks a breeding history and that breeding history is part of the minimum description of a plant variety the applicant has not fulfilled the requirement of 35 USC 112(a) to provide a written description in the specification. The office’s reasonable basis for challenging the adequacy of written description is informed by a review of the following: With regard to Plant Patents, MPEP 1605 states that a complete detailed description of a plant includes “the origin or parentage”.
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, (U)).
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 (V)).
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) (W) and Ex Parte McGowen Board Decision in Application 14/996,093, decided June 15, 2020 (X)). 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.
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 (Y)) 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 (Z), 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.
The above factual evidence provides a reasonable basis that a breeding history is necessary written description. With this information the examiner has met the initial burden of presenting by a preponderance of evidence why a person of ordinary skill in the art would not recognize in an applicant’s disclosure a description of the invention defined by the claims. (See MPEP 2163.04). Please note, the citations above are not for legal authority, the legal authority relied upon 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 to the adequate description of a plant.
Although not directly relied upon for the above written description position, a complete written description additionally helps drive examination and help with infringement verification.
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 breeding history aids 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.
Moreover, a specification devoid of a complete 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 complete 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.
Furthermore, a breeding history particularly parent lines is essential to search siblings of instant plant to determine if there is/are any double patenting(s).
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, the applicant must amend the specification/drawing to provide the breeding history used to develop the instant cultivar. When identifying the breeding history, the applicant should identify any and all other potential names for all parental lines utilized in the development of the instant cultivar and all other potential names for the claimed cultivar. If the applicant’s breeding history uses proprietary cultivar names, the applicant should notate in the specification all other names of the proprietary cultivars, especially publicly disclosed or patented cultivar information. If the breeding history encompasses a locus conversion or a backcrossing process, the 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, the applicant should provide the breeding history of the parent line as well (i.e., grandparents). The 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.
The applicant is reminded that they have a duty to disclose information material to patentability. The 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 cultivar). If there any patent applications or patents in which sibs or parents of the instant plant are claimed, the serial numbers and names of the sibs or parents should be disclosed. 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).
Remarks
The breeding history and parental lines of instant rice RT23L401 are missing in the instant specification. No art rejection(s) is/are made in this office action only. When such breeding history and parental lines of instant rice RT23L401 become available (See the 112a rejection above), the examiner will perform further search.
Response to Arguments
102 and 103 rejections
In view of the affidavit filed by Liping Diao on 4/10/2026, Chlapecka et al of University of Missouri, and University of Arkansas, directly obtained the subject matter from the applicant, Rice Tec, and disclosed the subject matter within one year before the instant filing date. Thus, both references, Chlapecka et al of University of Missouri, and University of Arkansas, qualify as 102(b)(1) exception.
Thus, the 102 and 103 rejections are withdrawn.
USC 35 112 (a) Lacking Written Description—Lacking breeding history and parent lines
Applicant respectfully refers the Examiner to the arguments previously submitted in the Response to Office Action filed September 12, 2025. As set forth in that response, Applicant provided an amended specification at [0205]-[0208] that includes a detailed breeding methodology and history of claimed hybrid rice RT23L401. In combination with the phenotypic information disclosed in Table 1 of the specification and the seed deposit made under ATCC Accession No. PTA-127535 in accordance with the Budapest Treaty and 37 C.F.R. §§1.801-1.809, Applicant respectfully submits that the specification satisfies the written description requirement of 35 U.S.C. §112(a). As previously argued, the touchstone of written description is whether a person of ordinary skill in the art would understand that the inventors were in possession of the claimed invention. See MPEP § 2163 Guidelines for the Examination of Patent Applications Under the 35 U.S.C. 112(a), quoting Capon v. Eshhar, 418 F.3d 1349, 1357, 76 USPQ2d 1078, 1084 (Fed. Cir. 2005) ("The 'written description' requirement implements the principle that a patent must describe the technology that is sought to be patented; the requirement serves both to satisfy the inventor's obligation to disclose the technologic knowledge upon which the patent is based, and to demonstrate that the patentee [inventor] was in possession of the invention that is claimed."). Here, there can be no question that the inventors were in possession of the claimed hybrid line, which has been fully reduced to practice and deposited as PTA-127535.
Moreover, In re Inari Agriculture, Inc. v. Pioneer Hi-Bred International, Inc., PGR2024- 00023, Paper 15 (P.T.A.B. Oct. 15, 2024) confirms that, for plant patents, the written description and enablement requirements of 35 U.S.C. §112(a) are satisfied by the combination of phenotypic information, breeding history, and seed deposit, all of which have been provided in the present application. In re Inari squarely rejects the notion that disclosure of the identity of parental lines is required to satisfy the written description requirement for claimed hybrid lines. Applicant has fully complied with these requirements by disclosing phenotypic data in Table 1 of the specification, providing breeding methodology and history in the amended specification at [0205]-[0208], and depositing seed under ATCC Accession No. PTA-127535.
The arguments are fully considered but not deemed persuasive.
The examiner noticed that in the amended specification of 9/12/2025 ([0205]-[0208]), “Hybrid Rice RT23L401 was bred by crossing a female parental line A ("Parent A") and male parental line B ("Parent B"). Hybrid Rice RT23L401 has essentially all physiological and morphological characteristics of Parent A and Parent B as listed in Table 1. Hybrid Rice RT23L401 is the filial generation F1 product of crossing parental lines A and B. Parental lines A and B are homozygous. They have been self-pollinated through a number of generations and are determined to be uniform and stable.
“A” and “B” are not real parental lines, and do not satisfy written description, and are not searchable for prior art and/or double patenting. Accordingly, the applicant does not provide the breeding history in the amendment of the specification.
Breeding history is part of the minimum description of a plant variety the applicant has not fulfilled the requirement of 35 USC 112(a) to provide a written description in the specification. The office’s reasonable basis for challenging the adequacy of written description is informed by a review of the following: With regard to Plant Patents, MPEP 1605 states that a complete detailed description of a plant includes “the origin or parentage”.
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, (U)).
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 (V)).
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) (W) and Ex Parte McGowen Board Decision in Application 14/996,093, decided June 15, 2020 (X)). 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.
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 (Y)) 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 (Z), 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.
The applicant further argues that the identity of at least one of the parental lines in the pending application is a trade secret, which is highly proprietary and confidential information. Mandatory disclosure of such proprietary information would undermine the well-established coexistence of trade secret and patent law recognized by the Supreme Court in Kewanee Oil Co. v. Bicron Corp., 416 US 470, 493 (1974), and in In re Sarkar, 575 F.2d 870, 872, 197 USPQ 788, 791 (CCPA 1978), which stated: [T]hat wherever possible, trade secret law and patent laws should be administered in such manner that the former will not deter an inventor from seeking the benefit of the latter, because, the public is most benefited by the early disclosure of the invention in consideration of the patent grant. If a patent applicant is unwilling to pursue his right to a patent at the risk of certain loss of trade secret protection, the two systems will conflict, the public will be deprived of knowledge of the invention in many cases, and inventors will be reluctant to bring unsettled legal questions of significant
current interest ... for resolution.
The Office has established extensive safeguards under MPEP §724 for trade secret materials, and requiring public disclosure of Applicant's trade secret information as part of the publicly disclosed patent specification would violate both the spirit and letter of these rules. Applicant respectfully maintains that the parental lines are not claimed as part of the invention, and there is no basis for requiring disclosure of trade secret parental line identities to satisfy the written description requirement.
Applicant further brings to the Examiner's attention that the Office has recently allowed two other patent applications filed by Applicant that were prosecuted using the same arguments and responses addressing the written description requirement as those presented in the instant application. Specifically, Application No. 18/298,591, which issued as U.S. Patent No. 12,582,062, entitled "Hybrid Rice RT23M402, " on March 24, 2026, and Application No. 18/161,685, which issued as U.S. Patent No. 12,575,519, entitled "Rice Cultivar RT22J502, " on March 17, 2026, were both allowed to proceed to issuance without any further inquiry regarding the identity of the parental lines. The issuance of these patents confirms that the information previously provided by Applicant, including the phenotypic data, breeding methodology and history, and seed deposit, is sufficient to satisfy the written description requirement under 35 U.S.C. § 112(a), and that disclosure of parental line identity is not a prerequisite for patentability. Applicant respectfully submits that consistent treatment of the present application is warranted.
The arguments are fully considered but not deemed persuasive.
The office has recently determined that the top-secret rules are still important rules, but do not apply to the breeding history and parent lines of the plant cases. As analyzed by the examiner, a breeding history particularly parent lines provides a description of the genetic background/structure of a plant, which distinguishes a particular plant from other plants. Without such, examiners cannot conduct complete searches, and patent infringement and/or double patenting can happen.
Again, in this particular case, the examiner is unable to conduct further search regarding the other name of instant RT23L401, and found prior art to make additional rejections. If the parent lines are disclosed, the examiner can conduct even further search, and find prior art, to make even more additional art and/or double patenting rejections.
Again, the office has recently determined that the top-secret rules are still important rules, but do not apply to the breeding history and parent lines of the plant cases. If the previous cases were examined now, the breeding history and parent lines are definitely required to satisfy written description requirement.
Conclusion
No claim is allowed.
Contact information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WAYNE ZHONG whose telephone number is (571)270-0311. The examiner can normally be reached 8:30am to 5:00pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bratislav Stankovic, can be reached on 571-270-0305. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Wayne Zhong/
Primary Examiner, Art Unit 1662
Prosecution Insights