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 .
Information Disclosure Statement
The applicant does not include an Information Disclosure Statement. The listed and cited reference(s) in the specification, is/are not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Status of claims
Applicant’s response filed 4/3/2026 has been entered.
Claims 1, 5, 15-16 have been amended.
The specification has been amended to include the NCIMD Accession Number 44412.
In summary, claims 1-19 are pending and examined in this office action.
All previous objections and rejections not set forth below have been withdrawn in view of the applicant’s amendment and/or upon further consideration. See “Response to Arguments” at the end of office action.
The following rejections are repeated, modified and/or added for the reasons of record as set forth in the last Office action of 1/23/2026, and/or necessitated by the applicant’s amendments. The applicant’s arguments filed 4/3/2026 have been thoroughly considered but are not deemed fully persuasive.
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 1-19 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 lettuce ‘Sunberg’.
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 lettuce line ‘Sunberg’. 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 “overview” and a “objective description” of the traits of ‘Sunberg’ ([0059]-[0072], Table 1), serving as a phenotypic description. However, there is no accompanying breeding history in the specification.
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
By name search, lettuce ‘Sunberg’ was disclosed Enza Zaden’s catalogs as early as 2/2025, after instant filing date. PDFs attached.
Otherwise, instant ‘Sunberg’ (or NCIMB 44412) has no prior art in patent, patent application or NPL. Prior art does not disclose any corn has all of the physiological and morphological characteristics of instant ‘Sunberg’.
However, the breeding history and parental lines of instant ‘Sunberg’ are missing in the instant specification. When such breeding history and parental lines become available (See the 112a rejection above), the examiner will perform further search.
Response to Arguments
Objection to the Specification, USC 35 112 (a) Enablement and USC 35 (b) Indefiniteness
The above objections and rejections are withdrawn in view of the amendments to the specification and claims.
The applicant states that “The undersigned, as an agent of record, attests that seeds of the lettuce variety 'Sunberg' were deposited on August 16, 2024, according to the Budapest Treaty in the National Collection of Industrial, Food and Marine Bacteria Ltd (NCIMB Ltd) as deposit number 44412, evidence of which deposit is submitted herewith. With respect to the required statement, the undersigned, an agent of record, submits that the seeds 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, and further submits for completeness that all requirements under 37 CFR 1.801-1.809 will be complied with”. See page 9 of the applicant’s argument, 2nd para.
USC 35 112 (a) Lacking Written Description—Lacking breeding history and parent lines
The rejection has been modified. The applicant’s argument is fully considered but not deemed persuasive.
Before going to each argument, the examiner would emphasize the following:
According to MPEP 2161 I (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 three requirements, written description, enablement and best mode are separate and distinct from each other.
According to MPEP 2163 I, “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.” Capon v. Eshhar, 418 F.3d 1349, 1357, 76 USPQ2d 1078, 1084 (Fed. Cir. 2005). Further, the written description requirement promotes the progress of the useful arts by ensuring that patentees adequately describe their inventions in their patent specifications in exchange for the right to exclude others from practicing the invention for the duration of the patent’s term. To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116. However, a showing of possession alone does not cure the lack of a written description. Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956, 969-70, 63 USPQ2d 1609, 1617 (Fed. Cir. 2002). For example, it is now well accepted that a satisfactory description may be found in originally-filed claims or any other portion of the originally-filed specification. See In re Koller, 613 F.2d 819, 204 USPQ 702 (CCPA 1980); In re Gardner, 475 F.2d 1389, 177 USPQ 396 (CCPA 1973); In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). However, that does not mean that all originally-filed claims have adequate written support. The specification must still be examined to assess whether an originally-filed claim has adequate support in the written disclosure and/or the drawings.
MPEP 2163 (I) states that “…. a deposit is not a substitute for a written description of the claimed invention. 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….”.
The criticality of a breeding history in assessing the intellectual property rights of a plant is well recognized in the field of plant breeding. 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 applicant argues that the written description requirement of 35 U.S.C. § 112(a) requires that the specification "clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed." In other words, the specification must show that "the inventor actually invented the invention claimed" and must "reasonably convey to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date." An application specification may show actual reduction to practice by describing testing of the claimed invention or, in the case of certain biological materials, by specifically describing a deposit made in accordance with 37 CFR 1.801.9. The MPEP further states that "description of an actual reduction to practice of a biological material may be shown by specifically describing a deposit made in accordance with the requirements of 37 CFR 1.801 et seq.
The argument is fully considered but not deemed persuasive. While a deposit is an essential part of a cultivar application, MPEP 2163 (I) states that “…. a deposit is not a substitute for a written description of the claimed invention. 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….”. The criticality of a breeding history in assessing the intellectual property rights of a plant is well recognized in the field of plant breeding. MPEP 1605 states that a complete detailed description of a plant includes “the origin or parentage”.
The applicant argues that where the Office determines that additional information is reasonably necessary to conduct examination, the proper vehicle is a requirement for information under 37 C.F.R. § 1.105(a)(1), not a demand to rewrite the specification as was done during prosecution of the instant application.
The arguments are fully considered but not deemed persuasive. The office has 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.
The applicant argues that examiner has pointed to no case law which indicates that a disclosure which describes an invention and enables the practice of that invention in accord with 35 U.S.C. § 112, in this case by depositing in a public depository the seed necessary for the practice of the invention, must also include additional information to assist in the examination process and make easier the examiner's search and patentability determination.
The argument is fully considered but not deemed persuasive. Again, MPEP 2163 (I) states that “…. a deposit is not a substitute for a written description of the claimed invention. 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….”. The criticality of a breeding history in assessing the intellectual property rights of a plant is well recognized in the field of plant breeding. MPEP 1605 states that a complete detailed description of a plant includes “the origin or parentage”.
In addition, 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 applicant further argues that the genotype of a plant, such as lettuce variety 'Sunberg', can be characterized through a genetic marker profile, which can identify plants of the same variety. Paragraph [0080], for example, discloses that techniques used to analyze variations in DNA sequences such as RFLP-enhanced selection and genetic marker enhanced selection (for example, SSR polymorphisms) may be utilized to perform such genetic marker profiles. Accordingly, reference to the deposit by the specification amounts to a description of identifiable genetic characteristics of the deposited variety that both define the claimed lettuce variety and distinguish it from other plants. As such, the instant specification not only provides a description of the physical traits of 'Sunberg', but, through reference to the deposit, also describes the claimed variety at the genetic level.
The argument is fully considered but not deemed persuasive. The above are general techniques, not unique sequence(s) that distinguishes the specific plant from other plant. Only a particular sequence or parent line(s) is sufficient.
The applicant argues that the Board confirmed that reference to a deposit constitutes a disclosure of the genetic sequence of the deposited variety in its Decision Denying Institution of Post-Grant Review issued in Inari Agriculture, Inc. v. Pioneer Hi-Bred International, Inc., PGR2024-00023 (PTAB Oct. 15, 2024) ("Inari"). In Inari, the Board found that "[b]y depositing the seeds, Patent owner is making the genetic sequence (genotype) of [variety] available". In sum, Applicant's specification, combined with the disclosed deposit, provides disclosure of both the physical and genetic characteristics of the claimed variety and would have led one of skill in the art to conclude that Applicant was in possession of the claimed invention at the time the application was filed. The specification therefore complies with the written description requirement of 35 U.S.C. § 112(a).
The argument is fully considered but not deemed persuasive.
In fact, The Federal Circuit decided that “Inari’s petition raises only constitutional challenges that it did not directly raise before the Patent Office. “It is well-established that a party generally may not challenge an agency decision on a basis that was not presented to the agency.” In re DBC, 545 F.3d 1373, 1378 (Fed. Cir. 2008)”. See page 2 of the Order 2025-150.
In addition, the examiner would like to point out that the parental information would solve the dispute in a more convincing manner.
The applicant again argues that additional information regarding breeding history is not a § 112(a) written description requirement. Rather, should additional information on the breeding history be reasonably necessary to conduct examination, the proper vehicle is a requirement for information under 37 C.F.R. § 105(a)(1), as has previously been the long-standing practice of the Office.
Again, the office has 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. It is a newly established requirement. Most of the plant patent applicants, including Monsanto and Pioneer Hi Bred, has decided to comply.
Conclusion
No claim is allowed.
THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). The 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 extension fee 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 date of this final action.
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.
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, 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.
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.
/Wayne Zhong/
Primary Examiner, Art Unit 1662
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