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 .
Election/Restrictions
Applicant's election with traverse of claims 6-11 and the elected species Fictibacillus solisalsi G5L2 in the reply filed on 3/17/2025 is acknowledged.
Applicant argues that the examiner has failed to establish that search of the application would be an undue burden as required by MPEP § 803. This is not found persuasive because the instant application is a national stage application submitted under 35 U.S.C. 371, and therefore requires unity of invention analysis rather than the independent and distinct analysis required for applications filed under 35 U.S.C. 111(a). Applicant is directed to MPEP § 823. The unity of invention analysis does not require establishment of undue burden.
Applicant additionally argues that the technical feature shared by the inventions, the bacterial strains of claims 1-3, is a special technical feature and the claims were not interpreted in light of the description when establishing lack of unity. Applicant does not specify which aspects of the disclosure should be considered in the determination of lack of unity. However, the specification describes the strains of claims 1-3 as capable of controlling plant disease when applied to a plant seed, root, stem, leaf, plant support, nutrient solution, or soil (pg. 5). The bacteria were isolated from the leaves of tomato plants (pg. 14). The disclosure further describes the strains as disease control agents of soil-borne plant diseases such as bacterial wilt and soft rot (pg. 13).
When interpreted in light of the description, the inventions of groups I-IV do not share a special technical feature. As set forth in the restriction requirement, Ji teaches Bacillus sp. isolated from a plant leaf which are then applied to the soil of mulberry plants to prevent bacterial wilt (Ji pg. 566 Materials and Methods). Additionally, Liu teaches Bacillus sp. and Fictibacillus solisalsi applied to cabbage plants to treat black rot (Liu pg. 8 Abstract, pg. 9 Materials and Methods). Thus, these references teach Bacillus sp. and Fictibacillus solisalsi bacterial strains for controlling soil-borne plant disease when applied to soil and to plant seedlings. Further, as set forth in the rejection under U.S.C. § 102 or 103 below, it would have been obvious to use the strains as claimed in a plant disease control agent. Therefore, the strains of claims 1-3, when interpreted in light of the description, do not make a contribution over the prior art.
The requirement is still deemed proper and is therefore made FINAL. Claims 6-11 are being examined on the merits.
Claims 1-5 and 12-16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 3/17/2025.
In light of the prior art search, the species election requirement is withdrawn.
Information Disclosure Statement
The information disclosure statement (IDS) filed on 11/29/2022 is acknowledged and has been considered.
Claim Objections
Claim 6 is objected to because of the following informalities:
Claim 6 line 2 recites “selected form the group”. This should read “selected from the group”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
Claims 6-11 are rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, as containing 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. The disclosure does not enable one of ordinary skill in the art to practice the invention without access to the specific biological material, which is critical or essential to the practice of the invention but not included in the claims. See In re Mayhew, 527 F.2d 1229, 188 USPQ 356 (CCPA 1976).
The invention appears to employ novel biological materials, specifically bacterial strains Bacillus sp. G4L1 strain (NITE BP-03204), Bacillus timonensis G5S1 strain (NITE BP-03206), and Fictibacillus solisalsi G5L2 strain (NITE BP-03205). Since the biological materials are essential to the claimed invention, they must be obtainable by a repeatable method set forth in the specification or otherwise be readily available to the public. If the biological material is not so obtainable or available, the requirement of 35 U.S.C. 112 may be satisfied by a deposit of the biological materials.
The specification does not disclose a repeatable process to obtain the biological materials and it is not apparent if the biological materials are readily available to the public. It is noted that the Applicant has deposited the bacterial strains at The National Institute of Technology and Evaluation, NITE Patent Organism Depositary (2-5-8, Kazusa-Kamatari, Kisarazu-shi, Chiba, 292-0818, Japan; April 20, 2020) with the deposition numbers NITE BP-03204, NITE BP-03206, and NITE BP-03205, but there is no indication in the specification as to public availability. If the deposit 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, stating that the specific strains have been deposited under the Budapest Treaty and that the strain will be irrevocably and without restriction or condition released to the public upon the issuance of a patent and a receipt showing that the appropriate biological material was received and entered into the depository, would satisfy the deposit requirement made herein.
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 C.F.R. 1.801-1.809 applicants 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 indicating that:
a) during the pendency of this 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) a test of the viability of the biological material at the time the deposit was made and that such test result indicated that said biological material was viable (see 37 C.F.R. 1.807); and;
e) the deposit will be replaced if it should ever become inviable.
Claim Rejections - 35 USC § 101
Claims 6-11 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?
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?
Prong 2: If the claim recites a judicial exception, does it recite additional elements that integrate the judicial 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?
Analysis: Claims 6-11
Step (1): Yes. Claims 6-11 are directed to a product.
Step (2A):
Prong 1: Yes. Claims 6-11 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.
Prong 2: No. Claim 6 recites that the agent comprises at least one of the G4L1, G5S1, or G5L2 bacterial strain or culture, with no further limitations to integrate the agent into a practical application. Claims 7, 8, and 10 recite the additional limitations that the agent is capable of controlling plant disease by being applied to a plant part. The limitation “by being applied to” is an intended use limitation that does not limit the product structurally. See MPEP § 2111.02. The broad recitation of “applying” the strains does not integrate the product into a practical application. Claims 9 and 11 recite the additional limitation that the bacterium in the disease control agent “is capable of controlling a plant disease”, which is a characteristic of the naturally occurring bacterium and does not integrate the product into a practical application.
Step (2B): No. Claim 6 does not recite further limitations to amount to significantly more than the judicial exception. The intended use limitations recited in claims 7, 8, and 10 do not limit the product structurally and thus do not amount to more than the judicial exception. The additional limitations of claims 9 and 11 recite characteristics of the naturally occurring bacteria and these do not amount to significantly more than the judicial exception.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 6-11 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Chen et al., Environmental microbiology; 15(3):848-64.
Regarding claim 6, Chen teaches wild Bacillus subtilis strains isolated from rhizosphere soils and used in a plant disease control agent (Chen pg. 11 “Bacterial strains and culture conditions”, “Isolation and characterization of B. subtilis wild strains”, pg. 13 “Assays of biocontrol efficacy under greenhouse conditions”). The claimed Bacillus sp. G4L1 strain was isolated from a tomato plant and not modified from its natural state (specification pg. 14). As Chen teaches Bacillus sp. strains that were isolated from nature, unmodified, and used for the same purpose, controlling plant disease, Chen anticipates the disease control agent of instant claim 6.
Regarding claim 7, Chen teaches the agent according to claim 6 that is capable of controlling a plant disease, as set forth above. The limitation “by being applied to at least one selected from the group consisting of a plant seed, a plant root, a stem and leaf portion of a plant, a plant support, a nutrient solution, and soil” is an intended use limitation, and any product having this same structure is capable of performing the intended use. See MPEP § 2111.02. As Chen teaches the plant disease control agent according to claim 6, this product is capable of performing the intended use. However, Chen additionally teaches that the agent is applied as irrigation to each pot, i.e. as a nutrient solution (Chen pg. 13 “Assays of biocontrol efficacy under greenhouse conditions”).
Regarding claim 8, Chen teaches the agent according to claim 6 that is capable of controlling a plant disease as set forth above. The limitation in claim 8, “by being applied to at least one selected from the group consisting of a vegetable, a fruit, an Oryza plant, and a Poaceae plant” is an intended use limitation, and any product having this same structure is capable of performing the intended use. As Chen teaches the plant disease control agent according to claim 6, this product is capable of performing the intended use. However, Chen additionally teaches that the agent is used to treat disease of a vegetable, tomatoes (Chen pg. 1 “Summary”).
Regarding claim 9, Chen teaches the agent according to claim 6 that is capable of controlling a plant disease as set forth above. Chen teaches controlling disease in tomatoes, which are Solanaceae vegetable plants as described on page 26 of the instant specification (Chen pg. 1 “Summary”).
Regarding claim 10, Chen teaches the agent according to claim 7 as set forth above. Chen additionally teaches that the agent is capable of controlling a soil-borne plant disease, bacterial wilt caused by soilborne bacterium Ralstonia solanacearum (Chen pg. 1 “Introduction”). The limitation “by being applied to stems, leaves of a plant, or a combination thereof” is an intended use limitation, and any product having this same structure is capable of performing the intended use. As Chen teaches the plant disease control agent according to claim 6, this product is capable of performing the intended use and the teachings of Chen anticipate instant claim 10.
Regarding claim 11, Chen teaches the agent according to claim 10 as set forth above. Chen teaches that the agent controls bacterial wilt in a Solanaceae vegetable, tomatoes (Chen pg. 1 “Summary”).
Chen teaches a Bacillus sp. strain, but does not expressly teach Bacillus sp. G4L1, Bacillus timonensis G5S1, or Fictibacillus solisalsi G5L2 as instantly claimed.
Regarding claims 6-11, Chen teaches wild Bacillus subtilis strains isolated from rhizosphere soils and used in a plant disease control agent (Chen pg. 11 “Bacterial strains and culture conditions”, “Isolation and characterization of B. subtilis wild strains”, pg. 13 “Assays of biocontrol efficacy under greenhouse conditions”). As set forth above, Bacillus sp. G4L1 was isolated from a tomato plant and not modified (specification pg. 14). The Bacillus sp. strains taught by Chen have the same function as the claimed G4L1 strain, which is the capability of controlling plant disease. The Bacillus strains taught by Chen, like the instantly claimed strain, can control plant disease when applied as a nutrient solution (Chen pg. 13 “Assays of biocontrol efficacy under greenhouse conditions”). Additionally, the strains taught by Chen can control bacterial wilt, a soil-borne disease of Solanaceae vegetable plants, as recited in instant claims 8-11 (Chen pg. 1 “Summary” and “Introduction”).
Thus, given that the strains taught by Chen are also Bacillus sp. and have the same functional capabilities as Bacillus sp. G4L1, these strains are obvious variants of the instantly claimed strains. It would therefore be obvious to a skilled artisan to use the claimed Bacillus G4L1 strain in a plant disease control composition as taught by Chen, as the strains taught by Chen are similarly natural isolates from plants and are used to control soil-borne plant diseases, such as bacterial wilt, of the same types of plants as the instant strains.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 6-8 and 10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, 9-10, 12, and 14-17 of copending Application No. 18/555,813 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both are drawn to a plant disease control agent comprising a natural bacterial isolate from a plant.
Regarding instant claim 6, claim 1 of copending application ‘813 teaches a bacterial strain Lysinibacillus xylanilyticus GIC41. Claim 5 teaches that this strain has a plant disease control effect. Claim 9 recites a plant disease control agent comprising this bacterium.
Regarding instant claim 7, claims 14-17 of copending application ‘813 recite a method of treating plant disease by applying the disease control agent to a plant, plant seed, soil, or rhizosphere.
Regarding instant claim 8, claim 12 of copending application ‘813 recites the plant disease control agent for diseases of Amaranthaceae plants, a family which includes vegetables.
Regarding instant claim 10, claim 10 of copending application ‘813 recites the plant disease control agent for controlling soil-borne diseases.
While copending application ‘813 does not teach the Bacillus sp. G4Ll bacterial strain, Bacillus timonensis G5Sl bacterial strain, or Fictibacillus solisalsi G5L2 bacterial strain, it would have been obvious to a skilled artisan to use the instantly claimed strains as plant disease control agents as taught by copending application ‘813. The strain of copending application ‘813 is a natural isolate with the same function of controlling soil-borne plant disease, and is therefore an obvious variant of the instantly claimed strains.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 9 and 11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 9, 10 and 12 of copending Application No. 18/555,813 in view of Chen et al., Environmental microbiology; 15(3):848-64.
Regarding instant claim 9, claims 9, 10 and 12 of copending application ‘813 recites a naturally isolated bacterial strain Lysinibacillus xylanilyticus GIC41 as a plant disease control agent for soil-borne diseases of Amaranthaceae plants, a family which includes vegetables. The claims of copending application ‘813 do not recite that the plant is a Solanaceae or Brassicaceae plant.
However, Chen teaches wild Bacillus subtilis strains isolated from rhizosphere soils and used in a plant disease control agent (Chen pg. 11 “Bacterial strains and culture conditions”, “Isolation and characterization of B. subtilis wild strains”, pg. 13 “Assays of biocontrol efficacy under greenhouse conditions”). Chen teaches controlling disease in tomatoes, which are Solanaceae vegetable plants as described on page 26 of the instant specification (Chen pg. 1 “Summary”). As the strains taught by Chen are also Bacillus sp. and have the same functions as Bacillus sp. G4L1, the strains are obvious variants of the instantly claimed strains.
Regarding instant claim 11, claim 10 of copending application ‘813 recites the plant disease control agent for controlling soil-borne diseases of instant claim 10. The claims of copending application ‘813 do not recite that the agent controls bacterial wilt or soft rot of vegetables.
However, the strains taught by Chen can control bacterial wilt, a soil-borne disease of Solanaceae vegetable plants (Chen pg. 1 “Summary” and “Introduction”).
It would have been obvious to a person having ordinary skill in the art to combine the teachings of Chen with the teachings of copending application ‘813 and use the Lysinibacillus xylanilyticus GIC41 as a plant disease control agent for Solanaceae plants. It additionally would have been obvious to use the strain of copending application ‘813 for controlling the specific soil-borne plant disease bacterial wilt as taught by Chen. Both of these strains are naturally occurring bacterial strains that are capable of controlling soil-borne plant diseases and are obvious variants of the instantly claimed strains as set forth above. It therefore would have been obvious to a skilled artisan to use the instantly claimed strains as plant disease control agents as taught by copending application ‘813.
This is a provisional nonstatutory double patenting rejection.
Conclusion
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 7:30am-5pm ET.
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/EMILY F EIX/Examiner, Art Unit 1653 /SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653