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 .
Status of Claims
Receipt of Arguments/Remarks filed on 10/13/2025 is acknowledged. Claims 1-16 were canceled. New claims 17-26 were added. Claims 17-26 are pending.
Priority
This application is a 371 of PCT/JP2021/020546 (5/8/2021) which claims priority to JP2020-094859 (5/29/2020) as reflected in the filing receipt issued on 3/17/2023.
The certified copy of the foreign priority document is not in English. Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Information Disclosure Statement
The information disclosure statement filed 10/13/2025 fails to comply with 37 CFR 1.98(a)(3)(i) because it does not include a concise explanation of the relevance, as it is presently understood by the individual designated in 37 CFR 1.56(c) most knowledgeable about the content of the information, of each reference listed that is not in the English language. It has been placed in the application file, but the information referred to therein has not been considered.
Withdrawn Rejections
The rejections of claims 6-11 under 35 U.S.C. § 112(a) and 35 U.S.C. § 102 are withdrawn. The rejection of claims 6-11 on the grounds of nonstatutory double patenting is withdrawn.
New, maintained, and modified rejections necessitated by amendment
Claim Rejections - 35 USC § 101
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 17-26 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception, product of nature, without significantly more.
A three-step inquiry has been established to determine subject matter eligibility under 35 U.S.C. 101, in accordance with MPEP § 2106:
Step (1): Is the claim directed to a process, machine, manufacture, or composition of matter?
Yes. Claims 17-26 are directed to a product.
Step (2A): Is the claim directed to a law of nature, natural phenomenon (product of nature), or an abstract idea?
Prong 1: Does the claim recite a law of nature, natural phenomenon, or an abstract idea?
Yes. Claims 17-26 are directed to a plant disease control agent
comprising naturally occurring Bacillus and Fictibacillus bacterial strains that
were isolated from tomato plants, which do not have markedly different
characteristics from the bacteria as they exist in nature. Claims 17 and 21 recite that the bacterial strains are in a granulated formulation. However, granulated formulation is not defined in the specification so as to differentiate the structure of bacteria in a granulated formulation compared to the naturally occurring bacteria. Under broadest reasonable interpretation, a granulated formulation of the bacteria includes formulations wherein the bacteria are in a dry, solid carrier. For example, a formulation in which the bacteria are naturally dried and aggregated could be considered a granulated formulation. As the specification does not define a granulated bacterial formulation, and there are no additional components recited in the claims, the claims still read on naturally occurring bacteria.
Prong 2: If the claim recites a judicial exception, does it recite additional elements that integrate the judicial exception into a practical application?
No. Claims 17 and 21 recite the additional element of a granulated formulation. This additional element does not integrate the exception into a practical application.
Step (2B): If the recited judicial exception is not integrated into a practical application, does the claim recite additional elements that amount to significantly more than the judicial exception?
No. Claims 17 and 21 recite the additional element of a granulated formulation. However, as discussed above, this formulation is not defined in the specification and therefore encompasses bacteria with a structure that does not differ from the bacteria in nature. This element does not amount to more than the judicial exception, as the claims still read on naturally occurring bacteria.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 17-20 and 22-25 are rejected under 35 U.S.C. 103 as being unpatentable over Fu et al., Microbes and environments; 35(4):ME20078 (published 10/2/2020) in view of Quimby et al., US 6,455,036 B1.
Regarding claims 17-20 and 22-25, Fu teaches biocontrol compositions comprising Bacillus sp. G4L1, G5S1, or G5L2 (Fu Abstract, Fig. 1). These bacterial compositions are applied to tomato plants (Fu pp. 4-5, “Primary Screening”, Fig. 1). Fu teaches that Bacillus G4L1 significantly suppresses the incidence of tomato bacterial wilt and displays consistent and significant disease suppression (Fu Abstract). Fu teaches that the bacteria are applied as a foliar spray, formulated in a liquid suspension (Fu p. 3 “Pot experiment”).
Fu does not teach that the bacteria are in a granulated formulation.
Regarding claim 17, Quimby teaches granulated formulations of biocontrol agents, including Bacillus sp. (Quimby col. 2 lines 60-67, col. 3 lines 1-10). Quimby teaches that the biocontrol agent is stable, and can be formulated as a sprayable composition (Quimby col. 2 lines 35-40). Quimby teaches that a granular formulation is good for storage and are easy to handle (Quimby col. 2 lines 49-52).
It would have been obvious to a person of ordinary skill in the art that the biocontrol strains of Fu could be formulated in a granular composition prior to foliar spraying. Quimby teaches that bacteria, including Bacillus, may be formulated as a granular composition for such a purpose. A skilled artisan would have been motivated to utilize a granulated formulation due to the beneficial properties taught by Quimby, such as storage and stability, with a reasonable expectation of success due to the teachings of Quimby that a granulated formulation can be made with all bacteria, fungi, yeasts, viruses, microsporidians, protozoa, and nematodes (Quimby col. 2 lines 65-67, col. 3 lines 1-3).
Response to Arguments
Applicant's arguments filed 10/13/2025 regarding the rejection under 35 U.S.C. § 101 have been fully considered but they are not persuasive.
Applicant argues that bacteria do not occur in nature in a granulated form, and have distinct functional and structural characteristics not present in naturally occurring bacteria, like improved handling and stability.
In response to this argument, it is noted that “granulated formulation” is not defined in the specification, and there is no disclosure of distinct structural characteristics of granulated bacteria. Under broadest reasonable interpretation, the structure of the bacteria in the composition would not necessarily differ from their natural form, as a granulated formulation could include, for example, formulations wherein the bacteria are in a dry, solid carrier, or formulations wherein the bacteria are naturally dried and aggregated, and therefore not structurally distinct from the bacteria as they occur in nature.
It is suggested that applicant amend the claims to specify additional elements that are included in the composition to differentiate the composition from the naturally occurring bacteria, or a formulation that clearly indicates a distinct structure, such as freeze-dried bacteria.
The rejections under 35 U.S.C. § 102/103 and on the grounds of non-statutory double patenting are withdrawn. Therefore, arguments regarding these rejections are moot.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EMILY F EIX whose telephone number is (571)270-0808. The examiner can normally be reached M-F 8am-5pm ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sharmila Landau can be reached at (571)272-0614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/EMILY F EIX/Examiner, Art Unit 1653
/JENNIFER M.H. TICHY/Primary Examiner, Art Unit 1653
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