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 .
DETAILED ACTION
This application is a US national phase of PCT/JP2021/023736, filed June 23, 2021, with foreign priority application JP2020-111696, filed June 29, 2020.
Applicant’s amendment filed March 27, 2026 is acknowledged. Claims 3, 5-6, 8, 10, and 15-17 are canceled, and claim 19 is newly added. Claims 1-2, 4, and 18 are amended. Currently claims 1-2, 4, 7, 9, 11-14, and 18-19 are pending, wherein claims 7, 9, and 11-14 are withdrawn. Claims 1-2, 4, and 18-19 are under examination.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on March 27, 2026 has been entered.
Claim Objections
Claims 1 and 4 are objected to because of the following informalities:
Claim 1, line 1, needs to be changed to “…a bacterium having a 16S rRNA gene that contains a
Claim 4, lines 1-4, needs to be changed to “A control agent comprising at least one : NITE BP-03197, NITE BP-03198,…” for typographical errors.
Appropriate correction is required.
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 1-2, 4, and 18-19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a naturally occurring organism without significantly more.
The Supreme Court has required analysis based on a 3-part test for subject
matter eligibility.
Step 1: Is the claim to a process, machine, manufacture, or composition of
matter?
Step 2A (The Judicial Exceptions): Prong 1: Is the claim directed to a law of nature, a natural phenomenon (product of nature), or an abstract idea?
Step 2A (The Judicial Exceptions): Prong 2: Does the claim recite additional
elements that integrate the judicial exception into a practical application?
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception?
Claims 1-2, 4, and 19 recite a control agent comprising a dried, dead bacterium having a 16S rRNA gene that contains the nucleotide sequence that is SEQ ID NO: 1 (as evidenced by the Specification is the bacterium with accession number NITE BP-03197, para 82), and a dried, dead bacterium with Accession number NITE BP-03198, NITE BP- 03199, NITE BP-03200, NITE BP-03201, or NITE BP-03202, and an aggregation inhibitor, and claim 18 recites a mixture comprising a bacterium recited in claim 4 and agricultural product, thus is a composition which is a statutory category of invention (Step 1: Yes).
The claims are drawn to bacteria with accession number NITE BP-03197, NITE BP-03198, NITE BP- 03199, NITE BP-03200, NITE BP-03201, or NITE BP-03202, which are all Lactobacillus sp. isolated from the plant Quercus serrata as evidenced by the specification in Example 1. There is no evidence that these particular Lactobacillus species have any markedly different characteristic from other Lactobacillus species isolated from plants, nor that they have been genetically modified or altered that would enhance functionality in the ability as a control agent for plant disease. Furthermore, the limitation of a ‘dried, dead bacterial cell’ is a natural state of a bacterium’s lifecycle, therefore a natural product. Thus, the Lactobacillus species recited in the claims are naturally occurring organisms that is a judicial exception in the form of being a product of nature (Step 2A, Prong 1: Yes).
Claim 18 recites a mixture comprising the control agent of claim 4 and a second component comprising an agricultural product. Generic formulations of control agents comprising Lactobacillus species and agricultural products are a well-understood, routine practice in the industry. As evidenced by Murthy et al. (Pest Management in Horticultural Ecosystems, 2012, Vol. 18, No. 1, 60-65, cited in IDS filed 10/29/2024), lactic acid bacteria strains showed maximum inhibition against wilt pathogen, R. solanacearum on seeds of tomato plant varieties (abstract).
Claim 19 recites the control agent comprising the bacterium of claim 4 further comprises an aggregation inhibitor; however, an aggregation inhibitor is merely an additional formulation component added to the naturally occurring bacterium and is not recited as performing any meaningful transformation or other practical application of the judicial exception. Neither does the specification disclose any specific non-naturally occurring compound with the functional characteristic as an aggregation inhibitor. Thus, the claims do not recite additional elements that integrate the judicial exception into a practical application (Step 2A, Prong 2: No).
Claims 18-19 also do not recite additional elements that amount to significantly more, merely appending a generic formulation component to a natural product, thus do not amount to significantly more than the judicial exception (Step 2B: No).
Therefore, claims 1-2, 4, and 18-19 are not patent eligible subject matter.
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.
Claim 4 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 5 and 7 of copending Application No. 18/577017 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by the copending claims.
Claims 5 and 7 of ‘017 are drawn to a composition comprising bacterial cells or cell culture product comprising a bacterium selected from NITE BP-03198, NITE BP- 03199, NITE BP-03200, NITE BP-03201, or NITE BP-03202, which are those recited in instant claim 4.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 4 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of copending Application No. 18/576842 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by the copending claims.
Claims 1-6 of ‘842 are drawn to a composition comprising bacterial cells or cell culture product comprising a bacterium selected from NITE BP- 03199, NITE BP-03200, or NITE BP-03201, which are those recited in instant claim 4.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant's arguments filed March 27, 2026 have been fully considered but they are not persuasive.
Regarding Remarks directed to the 101 rejection, Applicant argues Independent claims 1 and 4 satisfy 35 U.S.C. § 101 under the "markedly different characteristics" analysis discussed in MPEP § 2106.04(c). As shown in the Declaration of Naoya Ozawa attached hereto, the forgoing independent claims recite components or features that make the claims as a whole markedly different from the product as found in nature. See Ozawa Declaration, para 7. Paragraph [0063] of the specification states, "The bacterial cells may be present in a culture solution, a buffer, or the like, or may be a product obtained by concentrating them and removing the liquid or a freeze-dried product thereof." Accordingly, the dried dead bacterial cells of amended claim 1 amount to something more than what is found in nature. Specifically, independent claims 1 and 4 recite that the bacterium is a dried dead bacteria cell. Dried dead bacterial cells are distinct from natural products (e.g., live bacterial cells). See Ozawa Declaration, 5-7. Further, the dried dead bacterial cells exhibit significant antibacterial activity against the bacteria causing bacterial wilt disease that exceeds that of natural products. See Ozawa Declaration, 5-6. Indeed, the wilt fungus growth inhibition of the dried dead bacterial cells is significantly higher than live equivalent bacterial cells. See Ozawa Declaration, 6. Therefore, claims 1 and 4 recite markedly different characteristics from nature since the dried dead bacterial cells demonstrate significantly more antibacterial activity against wilt disease bacteria than live bacterial cells. Thus, each of the recited elements of the independent claims as provided above, would impact the structure and/or function of the alleged naturally occurring product as a whole, resulting in claimed features that have "markedly different characteristics" as compared to any naturally occurring component. Accordingly, the patent-eligibility requirements of § 101 are satisfied and any dependent claims therefrom should also be considered patent-eligible. See MPEP § 2106.04(c).
As discussed above in the 101 rejection, adding the limitation ‘dried, dead bacterial cells’ is a natural state of a bacterium’s life cycle, and the scope is broad to include naturally dried dead bacterial cells that exist in nature, thus do not transform the bacteria into a different state. The Examiner recommends amending the claims to ‘freeze-dried dead bacterium’ to obviate the 101 rejection.
Regarding Remarks directed to the nonstatutory double patenting rejection, Applicant requests that the double patenting rejection over co-pending applications 18/577017 and 18/576842 be held in abeyance (Remarks p. 7). A request to hold a rejection in abeyance is not a proper response to a rejection. Rather, a request to hold a matter in abeyance may only be made in response to an OBJECTION or REQUIREMENTS AS TO FORM (see 37 CFR 1.111(b) and MPEP §714.02). Thus, the double patenting rejections of record have been maintained as no response to these rejections has been filled by applicant at this time.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JESSICA EDWARDS whose telephone number is (571)270-0938. The examiner can normally be reached M-F 8am-5pm EST.
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/LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657
/JESSICA EDWARDS/
Examiner, Art Unit 1657
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