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 .
Examiner Note: Applicant is invited to set up an interview to discuss amending the claims over the 101 and 112 issues below.
Acknowledgement of Declaration
The Declaration filed on 04/22/2026 does provide evidence that the Eustoma grandiflorum plant of claim 1 is not a naturally occurring plant. The Declaration states that the recited SNP markers of claim 1 were found in the genome of Eustoma exaltatum, which was then crossed with Eustoma grandiflorum to produce the instant plant of claim 1. Due to their geographically separated habitats, natural cross-breeding of these two species is practically impossible.
Status of Claims
The amendments received on 04/22/2026 have been entered. Claims 1, 4, 6-8, 10-16, 18, 20-22, and 26 are pending.
Claims 2, 5, and 19 have been cancelled.
Claims 13-16, 18, 20-22, and 26 remain withdrawn for being directed to a non-elected
invention(s).
Claims 1, 4, 6-8, 10-11, 13-16, 18, 20-22, and 26 have been amended.
Claims 1, 4, 6-8, and 10-12 are examined in this office action.
Priority
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in Japan on 10/22/2021. It is noted, however, that applicant has not filed a certified copy, in English, of the JP2021-173508 application as required by 37 CFR 1.55.
Objections/Rejections that are Withdrawn
All objections to and rejections of claims 2 and 5 have been rendered moot by Applicant’s cancellation of the claims.
The objection to the Specification has been withdrawn in light of Applicant’s amendments to the Specification.
The rejection of claim 4 under 35 USC 112(b) Indefiniteness has been withdrawn in light of Applicant’s amendment to the claim.
The rejection of claims 1, 4, 6-8, and 10-12 under 35 USC 112(a) Written Description has been withdrawn in light of Applicant’s amendments to the claims and accompanying arguments (Remarks, pages 13-15). However, Applicant’s amendments have raised new grounds for a 35 USC 112(a) Written Description rejection to claims 11 and 12.
The rejection of claims 4 and 6-8 for Improper Markush Grouping has been withdrawn in light of Applicant’s accompanying arguments (Remarks, page 16).
The rejection of claims 1, 4, 6-8, and 10-12 under 35 USC 101 has been withdrawn in light of Applicant’s Declaration dated 04/22/2026. However, Applicant’s amendments have raised new grounds for a 35 USC 101 rejection.
The text of those sections of Title 35, U.S. Code, not included in this action, can be found in a prior Office action.
Claim Objections
Claims 4, 6, and 10 are objected to because of the following informalities: claims 4, 6, and 10 recite the limitation "the Eustoma fusarium wilt resistance locus". Claims 4, 6, and 10 depend from claim 1; claim 1 does not recite “a Eustoma fusarium wilt resistance locus". Therefore, there is insufficient antecedent basis for this limitation in claims 4, 6, and 10. Although the Eustoma fusarium wilt resistance locus is inherent to the markers, applicant should still either add the Eustoma fusarium wilt resistance locus to claim 1, or provide antecedent basis for the locus to claim 6.
Likewise, claim 6 recites the limitation "on the chromosome". Claim 6 depends from claim 1; claim 1 does not recite “a chromosome". Therefore, there is insufficient antecedent basis for this limitation in claim 6.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
Written Description
Claims 11 and 12 remain rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. All dependent claims are included in these rejections unless they contain a limitation that overcomes the deficiencies of the parent claim from which they depend. This is a new rejection necessitated by amendment.
Claim 11 recites “[a] part of the Eustoma fusarium oxysporum wilt-resistant Eustoma grandiflorum plant according to claim 1”.
Applicants describe the identification of a fusarium wilt-resistant Eustoma line that exhibits a high degree of fusarium wilt resistance (Example 1, page 75, paragraph 0189).
Applicants describe the identification of a Eustoma fusarium wilt resistance locus on chromosome 20 between 3,703,734bp and 3,961,378bp (Example 1, page 77, paragraph 0197).
Applicants describe the identification of 66 SNP markers, including Egra20_3703734, Egra20_3759258, Egra20_3833476, Egra20_3839851, Egra20_3849059, Egra20_3854638, Egra20_3857016, Egra20_3879982, Egra20_3914662, Egra20_3939402, and Egra20_3961378 within the Eustoma fusarium wilt resistance locus on chromosome 20 (Tables 5A-C, pages 81-83, paragraphs 0205-0207).
Applicants describe the identification of a correlation between five SNP markers (a-e) and the Eustoma fusarium wilt resistance in eleven lines from F2 and F3 generations (Example 1, Table 3, page 77, paragraph 0196). However, the results described in Table 3 demonstrate that individual markers are unlikely to be predictive of the Eustoma fusarium wilt resistance trait. Based on the information presented in Table 3 below, the identification of the Eustoma fusarium wilt resistance trait relies on the identification of more than one SNP marker on chromosome 20.
Additionally, the results described in Table 6 (see below; Example 4, page 84, paragraph 0210) further exemplify the likelihood of multiple markers being necessary for the identification of the Eustoma fusarium wilt resistance trait.
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Claim 1, upon which claim 11 depends, does not require the Eustoma grandiflorum plant to be Eustoma fusarium oxysporum wilt-resistant, only to comprise “at least one” of the recited SNP markers. The phrase “at least one” includes the possibility of the Eustoma grandiflorum plant comprising only one of the recited SNP markers. As exhibited in Tables 3 and 6, Eustoma fusarium oxysporum wilt-resistance was not shown to be identifiable by only one SNP marker. At the very least, and in an extremely small population of three plants, Eustoma fusarium oxysporum wilt-resistance was identified by three heterozygous SNPs (b, c, and d). In Table 3, lines 6 and 8, the presence of only Egra20_3961378 SNP (d) (either hetero- or homozygous) alone was not indicative of the Eustoma fusarium wilt resistance trait; and in Table 6, Pattern 4, the presence of only Egra20_3939402 SNP (l) (heterozygous) alone was not indicative of the Eustoma fusarium wilt resistance trait.
Given Applicants have not reduced to practice a Eustoma fusarium oxysporum wilt-resistant Eustoma grandiflorum plant comprising only one of the recited SNPs of claim 1, there is not an adequate written description to support the breadth of the claims. Therefore, one skilled in the art would not have recognized Applicants to be in possession of the claimed invention at the time the application was filed.
Missing Breeding History
Claim 10 remains 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.
Applicants describe the identification of a Eustoma wilt-resistant Eustoma plant. This Eustoma wilt-resistant Eustoma plant was deposited under Accession No. FERM BP-22427. However, the instant Specification inadequately describes what starting materials and methods were used to produce the FERM BP-22427 Eustoma plant
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 Eustoma wilt-resistant Eustoma plant. So, the examiner will evaluate what is an adequate written description for a new Eustoma wilt-resistant Eustoma plant. In reviewing this question of fact, the examiner analyzed how plant varieties 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, there is 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”.
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.
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 helps 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.
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 Eustoma wilt-resistant Eustoma plant. 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 Eustoma wilt-resistant Eustoma plant and all other potential names for the claimed Eustoma plant. If Applicant’s breeding history uses proprietary cultivar names, 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, 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 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).
Response to Applicant’s Arguments
Applicant's arguments filed 04/22/2026 have been fully considered but they are not persuasive.
Applicant argues that the present application is for a utility patent and therefore does not require a breeding history.
Applicant is reminded that they have a duty to disclose information material to patentability. Applicant should also notate 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).
Regarding Applicants’ arguments on whether a utility patent requires a breeding history, 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 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.
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 rebutted the evidence provided in the rejection. Applicant has not provided evidence demonstrating that the breeding history is not considered part of the description of a plant variety.
Enablement/Deposit of Biological Material
Claims 1, 4, 6-8, and 10-12 remain 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 Eustoma plant claimed is essential to the claimed invention, it must be obtainable by a repeatable method set forth in the Specification or otherwise be readily available to the public. If a Eustoma plant is not so obtainable or available, a deposit of seed thereof may satisfy the requirements of 35 U.S.C. § 112. A deposit of 650 seeds of each of the claimed invention is considered sufficient to ensure public availability. The Specification does not disclose a repeatable process to obtain the exact same Eustoma plant in each occurrence and it is not apparent if such a Eustoma plant is readily available to the public.
It is noted that Applicants have deposited a Eustoma plant under Accession No. FERM BP-22427 with the National Institute of Technology and Evaluation in Japan (page 64, paragraph 0133). However, there is no affirmative statement in the Specification that all restrictions upon availability to the public will be irrevocably removed upon granting of the patent.
If the deposit of these seeds was/is made under the terms of the Budapest Treaty, then an affidavit or declaration by the Applicants, or a statement by an attorney of record over his or her signature and registration number, or someone empowered to make such a statement, stating that the seeds have been deposited and accepted, 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 was/is not made under the Budapest Treaty, then in order to certify that the deposit meets the requirements set forth in 37 C.F.R. §§ 1.801-1.809, Applicants may provide assurance of compliance by statement, an affidavit or declaration, or by someone empowered to make the same, 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 in accordance with 37 CFR 1.808(a)(2);
(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 C.F.R. § 1.807); and
(e) the deposit will be replaced if it should ever become inviable.
Compliance with this requirement may be held in abeyance until the application is otherwise in condition for an allowance.
Response to Applicant’s Arguments
In regard to an affirmative statement that restrictions upon availability to the public will be irrevocably removed upon granting of the patent, Applicant states that “Applicant submits herewith a statement addressing this rejection”. However, the Examiner is unable to find such a statement in the file wrapper.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 4, 6-8, and 10-12 are rejected under 35 U.S.C. 101 because the claimed invention is not supported by either a specific and substantial asserted utility or a well-established utility.
Claim 1 recites “[a] Eustoma grandiflorum plant comprising at least one SNP marker selected from the group consisting of Egra20_3759258, Egra20_3833476, Egra20_3839851, Egra20_3849059, Egra20_3854638, Egra20_3857016, Egra20_3879982, Egra20_3914662, and Egra20_3939402”.
Applicant claims a Eustoma grandiflorum plant comprising at least one of the recited SNP markers. However, in the absence of provided specific function, the claim recitations merely encompass a Eustoma grandiflorum plant comprising at least one SNP marker. Furthermore, as stated previously, the phrase “at least one” encompasses the possibility of a Eustoma grandiflorum plant comprising only one of the recited SNP markers. As disclosed in Tables 3 and 6 (see Written Description rejection above), Applicants have not disclosed a single embodiment of a Eustoma grandiflorum plant comprising only one of the recited SNP markers able to perform the asserted function, nor have Applicants supplied evidence of a reasonable expectation of success of the claimed invention. Therefore, it is unclear how such claimed composition will provide any specific utility.
Applicants are reminded that an asserted utility must be specific and substantial. See MPEP § 2107.02. For example, a statement that a composition has an unspecified "biological activity" or that does not explain why a composition with that activity is believed to be useful fails to set forth a “specific and substantial utility.” Brenner v. Manson, 383 US 519, 148 USPQ 689 (1966) (general assertion of similarities to known compounds known to be useful without sufficient corresponding explanation why claimed compounds are believed to be similarly useful insufficient under 35 U.S.C. § 101); In re Ziegler, 992 F.2d 1197, 1201, 26 USPQ2d 1600, 1604 (Fed. Cir. 1993) (disclosure that composition is “plastic-like” and can form “films” not sufficient to identify specific and substantial utility for invention); In re Kirk, 376 F.2d 936, 153 USPQ 48 (CCPA 1967) (indication that compound is “biologically active” or has “biological properties” insufficient standing alone). See also In re Joly, 376 F.2d 906, 153 USPQ 45 (CCPA 1967); Kawai v. Metlesics, 480 F.2d 880, 890, 178 USPQ 158, 165 (CCPA 1973) (contrasting description of invention as sedative which did suggest specific utility to general suggestion of “pharmacological effects on the central nervous system” which did not). In contrast, a disclosure that identifies a particular biological activity of a compound and explains how that activity can be utilized in a particular therapeutic application of the compound does contain an assertion of specific and substantial utility for the invention. See MPEP § 2107.02.
The utility asserted in the claims for the claimed SNP markers is that they can be used to identify a Eustoma fusarium wilt resistance locus (see claim 4, for example). However, the Specification does not provide adequate support for the claimed invention with respect to individual SNP markers being indicative of Eustoma fusarium wilt resistance. This is not a specific and substantial utility, because further research would be required to determine how to use the product as claimed such that it may have a specific, substantial, and credible utility.
Additionally, Brenner v. Manson, 383 U.S. 519, 148 USPQ 689 (1996); In re Ziegler, 992 F.2d 1197, 26 USPQ2d 1600 (Fed. Cir. 1993) teach that inventions are unpatentable under 101 if Appellant fails to identify any specific and substantial utility for the invention or fails to disclose enough information about the invention to make its usefulness immediately apparent to those familiar with the technological field of the invention.
Thus, the claimed invention is not supported by a specific and substantial asserted utility for the reasons set forth above.
Claim Rejections - 35 USC § 112(a) Enablement
Claims 1, 4, 6-8, and 10-12 are also rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph. Specifically, because the claimed invention is not supported by either a specific or substantial asserted utility or a well-established utility for the reasons set forth above, one skilled in the art clearly would not know how to use the claimed invention.
Applicant has disclosed in Tables 3 and 6 the combinations and patterns of SNP markers indicative of a Eustoma fusarium wilt resistance locus. Applicant has also disclosed in Tables 3 (lines 6 and 8) and 6 (Pattern 4) that an individual SNP marker is not indicative of a Eustoma fusarium wilt resistance locus. Thus, Applicant’s claim of a Eustoma grandiflorum plant comprising individual (“at least one”) recited SNP markers would not lead one of ordinary skill in the art to immediately appreciate why the invention is useful.
Summary
No claim is allowed.
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.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINA MEADOWS whose telephone number is (703)756-1430. The examiner can normally be reached Monday - Friday 9:00 am - 5:00 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amjad Abraham can be reached at 571-270-7058. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/CHRISTINA L MEADOWS/Examiner, Art Unit 1663
CHRISTINA MEADOWS
Examiner
Art Unit 1663
/Amjad Abraham/SPE, Art Unit 1663
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