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 .
Reopening
Applicant's request for reconsideration of the finality of the rejection of the last Office action is persuasive and, therefore, the finality of that action is withdrawn.
Claim Status
The claim amendments as filed on 2/2/2026 have been entered.
Claims 1, 6, 14-15 have been amended.
Claims 2, 3 and 18 have been cancelled.
Claims 1, 4-17, 19 and 20 are currently pending.
Claims 1, 4-17, 19 and 20 are being examined in this application.
Priority
This application is filed under 35 U.S.C 371 of PCT/JP2022/00178 (filed on 01/06/2022), which claims foreign priority to JAPAN 2021-002474 (filed 01/09/2021).
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. For example, see [0037]. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Interpretation
The instant claim 1 recites a microbial material comprising a bacterial strain belonging to Bradyrhizobium ottawaense clade that is not strain OO99.
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, 4-17, 19 and 20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon/product without significantly more.
The claim(s) recite(s) naturally occurring bacteria strains. This judicial exception is not integrated into a practical application as discussed below. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception as discussed below. See MPEP 2106 for the streamlined analysis of subject matter eligibility evaluation.
In this case,
Step 1 Is the claim to a process, machine, manufacture or composition of matter?
Yes, the claims are drawn to a product/composition claim.
Step 2A Is the claim directed to a law of nature, a natural phenomenon (product of nature), or Abstract idea?
Step 2A Prong one (MPEP2106.04(c)): Does the claim recite a natural phenomenon (product of nature)? Yes, the instant claims are drawn to a bacteria strain or strain(s) that were isolated from nature (such as ones isolated from Sorghum roots), as stated in the instant specification (see Spec., pp12+; [0032]+). These isolated bacteria are not “markedly different” from its naturally occurring counterparts. In fact, they are the exact same bacteria strains as exist in nature without any functional and/or structural difference from the naturally existing ones.
Step 2A prong two (MPEP2106.04(d)): Does the claim recite additional elements that integrate the judicial exception into a practical application? No, in this case, there is no additional elements that integrate the judicial exception into a practical application. The claims recite no specific application, and only reciting the inherent properties of the bacteria strains. The claimed method of “causing the microbial material… to be in contact with a seed or a root of a plant” is what occurs in nature since the bacteria strains were isolated from plants in the field (Spec., page 7, para 2). Since the answer to 2A Prong two is “NO”, the analysis continues to Step 2B.
Step 2B (MPEP2106.05): Does the claim recite additional elements that amount to significantly more than the judicial exception? No. In this case, there is no additional elements that renders the claim as whole that amounts to significantly more. The isolated bacteria strains from nature are not modified in any way, and they functionalities are have not been changed/improved.
Therefore, the claims are not eligible subject matter under 35 U.S.C. 101.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 4, 5, 16 and 19-20 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 4 recites “wherein the bacteria strain further has an ANI value for the B. ottawaense type strain OO99 that is 95% or higher in ANI analysis,” which recitation is unclear. Claim 1 recites the bacteria strain is “other than a type strain OO99”, and thus excluding strain OO99 and/or similar type of strains. Then it is not clear how the claimed bacteria strain would be 95% in ANI comparing to OO99.
Claim 5 recites “(16S-23S rRNA intergenic region)” in the parenthetical. It is not clear if the 16S-23S rRNA intergenic region is an example of the ITS sequence. Thus renders the claim scope unclear.
Claims 16 and 19-20 depend on claims 4 and 5 and do not clarify the issues, and thus are rejected.
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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
Written Description Rejection
Claims 1, 4-17, 19 and 20 are rejected under 35 U.S.C. 112, 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(s), at the time the application was filed, had possession of the claimed invention.
The instant claims 1, 4-9, 11-17 and 19-20 recite compositions comprising bacterial strains of various origins with nitrogen fixing and N2O reduction capability.
The instant claim 10 is drawn to a method of applying the bacterial strain to a plant.
To satisfy the written description requirement, applicants may convey reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention.
Applicants may show possession of an invention by disclosure of drawings or structural chemical formulas that are sufficiently detailed to show that applicant was in possession of the claimed invention as a whole. See, e.g., Vas-Cath, 935 F.2d at 1565, 19 USPQ2d at 1118.
The written description requirement of 35 U.SC. 112 exists independently of enablement requirement, and the requirement applies whether or not the case involves questions of priority. The requirement applies to all inventions and includes chemical inventions. The fact that the patent is directed to method entailing use of compounds, rather than to compounds per se, does not remove patentee’s obligation to provide a description of the compound sufficient to distinguish infringing methods from non-infringing methods. See Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 920-23, 69 USPQ 2d 1886, 1890-93 (Fed. Cir. 2004).
With regard to the description requirement, applicants’ attention is invited to consider the decision of the Court of Appeals for the Federal Circuit, which holds that a “written description of an invention involving a chemical genus, like a description of a chemical species, ‘requires a precise definition, such as by structure, formula [or] chemical name,’ of the claimed subject matter sufficient to distinguish it form other materials.” University of California v. Eli Lilly and Co., 43 USPQ2d 1398, 1405 (1997), quoting Fiers v. Revel, 25 USPQ2d 1601, 1606 (Fed. Cir. 1993) (bracketed material in original) [The claims at issue in University of California v. Eli Lilly defined the invention by function of the claimed DNA (encoding insulin)].
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species or by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus. See Eli Lilly, 119 F. 3d at 1568, 43 USPQ2d at 1406.
Claims 1 and 11 are drawn to a genus of bacteria strains within the Bradyrhizobium ottawaense clade having nitrogen fixing and N2O reduction capabilities. Claim 10 is drawn to a method of using the genus of bacteria. Neither the instant specification nor the claims have demonstrated common structure and/or function for the claimed genus bacteria strains. In addition, no representative numbers of species for the claimed genus of bacteria are provided to show possession of the claimed entire genus of bacteria and methods of using them.
To provide evidence of possession of a claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. The factors to be considered include disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, or any combination thereof. (see MPEP 2163 II). In this case, the instant application did not provide any common core structure of the bacteria strains that would have nitrogen fixing and N2O reduction capabilities.
The instant disclosure only provided a few bacteria strains including SG09, SF21 and SH12. Three examples of bacteria strains are not enough to show possession of the entire genus of bacteria strains that can fix nitrogen. The instant claims are drawn to essentially trial and error processes that would involve isolating and/or identifying bacteria strains that can fix nitrogen and reduce N2O and conduct phylogenetic analyses. Without first isolating the bacteria strains with the desired functionalities (of fixing nitrogen), it would not be possible to conduct they phylogenetic analysis and then subsequence determination of their operational taxonomic unit, and ultimately to demonstrate possession of the entire claimed genus of bacteria strains.
Therefore, applicants are not in possession of the entire genus of microbial material that comprising Bradyrhizobium ottawaense clade strains, and method of using thereof. Applicant’s claimed scope represents only an invitation to experiment regarding possible bacteria strains that might be isolated and tested to have the desired functionalities of fixing nitrogen.
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.
Wasai-Hara
Claim(s) 1, 4-6, 8-12, 14-17 and 19-20 is/are rejected under 35 U.S.C. 102 (a)(1)as being anticipated by Wasai-Hara et al (Microbes Environ. Vol.35 (1): 1-6; 1/11/2020; cited previously).
The instant claim recites “A microbial material comprising a bacterial strain belonging to a Bradyrhizobium ottawaense clade having a nitrogen fixing capability and an N20 reduction capability, the bacterial strain being other than a type strain 0099 of the B. ottawaense clade;
wherein the bacterial strain belongs to a clade including the B. ottawaense type strain 0099 in evolutionary phylogenetic analysis in which the B. ottawaense type strain 0099 and one or more Bradyrhizobium distinct species thereof are included in an operational taxonomic unit (OTU); and
wherein the evolutionary phylogenetic analysis creates and analyzes, for each OTU, a linked sequence in which amino acid sequences are linked to each other, the amino acid sequences being encoded by genes of dnaG, frr, infC, nusA, pgk, pyrG, rplA, rplB, rplC, rplD, rplE, rplF, rplK, rplL, rplM, rplN, rplP, rplS, rplT, rpmA, rpoB, rpsB, rpsC, rpsE, rpsI, rpsJ, rpsK, rpsM, rpsS, smpB, and tsf extracted by using AMPHORA.”
The recitation of “operational taxonomic unit” is inherent property of the claimed bacteria strain, and the recitation of the “evoluationary phylogenetic analysis”, “amino acid sequences… encoded by genes” are inherent property of the bacteria strain as well. In essence, the instant claims are drawn to the bacteria strain. Any genetic analysis conducted on the bacteria and the results thereof do not change the structure of the bacteria strain.
For Claim 1, Wasai-Hara et al, teach different bacteria strains in Bradyrhizobium ottawaense family (e.g Abstract). The reference teaches, for example, SG09 (e.g. p.2, left col., Para 3) and SG11 (e.g. p.3, left col., para 3). The reference also teaches B. ottawaense has nitrogen fixing and N2O reduction capability (e.g. Abstract; p2+). The reference also teaches phylogenetic analysis of the bacteria strains (e.g. p.4).
For Claim 4, The reference teaches, for example, SG09 (e.g. p.2, left col., Para 3), which is at least 95% ANI with strain OO99 as evidenced by the instant specification (instant spec., [0007]+) and claims.
For Claim 5, The reference teaches, for example, SG09 (e.g. p.2, left col., Para 3), which is at least 97% ITS as evidenced by the instant specification (instant spec., [0007]+) and claims.
For Claim 6, The reference teaches, for example, SG09 (e.g. p.2, left col., Para 3).
For Claim 8, The recitation of “functions as a growth-promoting agent” is a recitation of inherent property or intended use. The reference teaches the same bacteria strain as instant claim, and thus would be capable of performing the same intended use, and/or possesses the same property.
For Claim 9, The recitation of “the plant is a leguminous plant” is a recitation of inherent property or intended use. The reference teaches the same bacteria strain as instant claim, and thus would be capable of performing the same intended use, and/or possesses the same property. In addition, the reference teaches soybean plant (e.g. p.3, left col.)
For Claim 10, The reference teaches SG09 was isolated from the roots of sorghum plants (e.g. p.3, left col., para 3), which reads on the method of contacting the seeds/roots of a plant with the bacteria strain.
For Claim 11, Wasai-Hara et al, teach different bacteria strains in Bradyrhizobium ottawaense family (e.g Abstract). The reference teaches, for example, SG09 (e.g. p.2, left col., Para 3) and SG11 (e.g. p.3, left col., para 3). The reference also teaches B. ottawaense has nitrogen fixing and N2O reduction capability (e.g. Abstract; p2+). The reference also teaches phylogenetic analysis of the bacteria strains (e.g. p.4).
For Claim 12 and 19-20, The reference teaches, for example, SG09 (e.g. p.2, left col., Para 3).
For Claim 14, The reference teaches, for example, SG09 (e.g. p.2, left col., Para 3), which is at least 95% ANI with strain OO99 as evidenced by the instant specification (instant spec., [0007]+) and claims.
For Claims 15-17, The reference teaches, for example, SG09 (e.g. p.2, left col., Para 3), which is at least 97% ITS as evidenced by the instant specification (instant spec., [0007]+) and claims.
Yu et al
Claim(s) 1, 4-6, 8-11 and 14-17 is/are rejected under 35 U.S.C. 102 (a)(1)as being anticipated by Yu et al (International Journal of Systematic and Evolutionary Microbiology. 64: 3203-3207; 2014; cited previously).
The instant claim recites “A microbial material comprising a bacterial strain belonging to a Bradyrhizobium ottawaense clade having a nitrogen fixing capability and an N20 reduction capability, the bacterial strain being other than a type strain 0099 of the B. ottawaense clade;
wherein the bacterial strain belongs to a clade including the B. ottawaense type strain 0099 in evolutionary phylogenetic analysis in which the B. ottawaense type strain 0099 and one or more Bradyrhizobium distinct species thereof are included in an operational taxonomic unit (OTU); and
wherein the evolutionary phylogenetic analysis creates and analyzes, for each OTU, a linked sequence in which amino acid sequences are linked to each other, the amino acid sequences being encoded by genes of dnaG, frr, infC, nusA, pgk, pyrG, rplA, rplB, rplC, rplD, rplE, rplF, rplK, rplL, rplM, rplN, rplP, rplS, rplT, rpmA, rpoB, rpsB, rpsC, rpsE, rpsI, rpsJ, rpsK, rpsM, rpsS, smpB, and tsf extracted by using AMPHORA.”
The recitation of “operational taxonomic unit” is inherent property of the claimed bacteria strain, and the recitation of the “evoluationary phylogenetic analysis”, “amino acid sequences… encoded by genes” are inherent property of the bacteria strain as well. In essence, the instant claims are drawn to the bacteria strain. Any genetic analysis conducted on the bacteria and the results thereof do not change the structure of the bacteria strain.
For Claims 1, 6, 11, Yu et al, teach different bacteria strains in Bradyrhizobium ottawaense family (e.g Abstract). The reference teaches, for example, OO99, OM9 and OO85 (e.g. p.3203, Table 1; Figure 1), which the OM9 and OO85 read on bacteria strain other than OO99. The reference also teaches the bacteria B. ottawaense have nitrogen fixing and N2O reduction capability (e.g. Abstract; p3202+). The reference also teaches phylogenetic analysis of the bacteria strains (e.g. Figure 1).
For Claims 4, 14, The reference teaches the OM9 and OO85 shares high sequence identify with OO99, for example, >99.6% of housekeeping genes (e.g. p.3204, left-right col. Bridging para), which reads on the ANI value of claim 4.
For Claims 5, 15-17, The reference teaches identical 16s rRNA sequence among the different strains (e.g. Abstract).
For Claim 8, The recitation of “functions as a growth-promoting agent” is a recitation of inherent property or intended use. The reference teaches the same bacteria strain as instant claim, and thus would be capable of performing the same intended use, and/or possesses the same property.
For Claim 9, The recitation of “the plant is a leguminous plant” is a recitation of inherent property or intended use. The reference teaches the same bacteria strain as instant claim, and thus would be capable of performing the same intended use, and/or possesses the same property. In addition, the reference teaches soybean plant (e.g. Abstract; p.3202)
For Claim 10, The reference teaches the bacteria strains were isolated from the roots of soybeans plants (e.g. Abstract; p.3202, right col.), which reads on the method of contacting the seeds/roots of a plant with the bacteria strain.
Conclusion and Correspondence
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUE LIU whose telephone number is (571)272-5539. The examiner can normally be reached M-F 9-5.
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 (director), Jennifer Michener can be reached at 571-272-1424. 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.
/SUE X LIU/Supervisory Patent Examiner, Art Unit 1616
Prosecution Insights