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 .
Claim Rejections - 35 USC § 112
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.
Claims 23-42 are 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. It is apparent that Bradyrhizobium japonicum LMG P-32018 is required to practice the claimed invention. As such the biological material must be known and readily available or obtainable by a repeatable method set forth in the specification, or otherwise known and readily available to the public. If it is not so obtainable or available, the requirements of 35 USC 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, may be satisfied by a deposit of the strain Bradyrhizobium japonicum LMG P-32018.
The process disclosed in the specification does not appear to be repeatable. It is
not clear that the invention will work with commonly available material and it is not
apparent if the biological material(s) considered necessary to make and use the
invention is both known and readily available to the public. It is noted that there is no
indication that Applicants deposited the biological material as disclosed in Claim
1; there is no indication regarding public availability.
If the deposit is made under the terms of the Budapest Treaty, then a statement,
affidavit or declaration by Applicants, or by an attorney of record over his or her
signature and registration number, or by someone in a position to corroborate the
facts of the deposit, that the instant invention will be irrevocably and without restriction
released to the public upon the issuance of a patent, would satisfy the deposit
requirements 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, Applicant
must 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, showing 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 effective life of the patent,
whichever is longer;
(d) a test of the viability of the biological material at the time of deposit will be
made (see 37 C.F.R. §1.807); and
(e) the deposit will be replaced if it should ever become inviable.
Applicant’s attention is directed to M.P.E.P. §2400 in general, and specifically to
§2411.05, as well as to 37 C.F.R. §1.809(d), wherein it is set forth that “the specification
shall contain the accession number for the deposit, the date of the deposit, the name and address of the depository, and a description of the deposited material sufficient to
specifically identify it and to permit examination.” The specification should be amended
to include this information; however, Applicant is cautioned to avoid the entry of new
matter into the specification by adding any other information.
Although Applicants have noted in the Specification that the biological material was deposited according to the Treaty of Budapest, a statement that the biological materials will be irrevocably and without restriction or condition released to the public upon the issuance of a patent is additionally required.
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 23-42, are 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.
Applicant recites in the claims that at least 99.90% (claim 23, 25 and 26), 99.95% (claim 27), and 99.98% (claim 28) genomic sequence identity is required of a Bradyrhizobium japonicum strain compared to Bradyrhizobium japonicum LMG P-32018, however the applicant does not claim the genomic sequence to B. japonicum LMG P-32018. Claims interpreted by this limitation are to include any sequence from the claimed Bradyrhizobium japonicum; therefore, interpreting the claim(s) as if the method(s) provided for “genomic sequence identity” is compared with SEQ ID NO.1, as this is the only sequencing data available and there are no whole genome sequences provided.
Claims 24 and 29-42 depend from and fail to cure the deficiencies of the claims discussed above.
Claim Rejections - 35 USC § 102/103
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.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 23-42 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 Naoko,O. et al. (JP2021090395A published 2021-06-17).
Regarding claim 23-26, 27-29, 36-39, and 40-42 Naoko, O et al., discloses a method to enhance soybean plants by inoculating a plant growth medium (yeast mannitol agar and/ or broth) with B. japonicum strain GEM96, wherein B. japonicum enhances plant growth and yield characteristics (page 3, claim 2, 3 and 4) at 20°C or less (page 3, claim 6). The microbial population are provided as a liquid, powders, granules, and fumigants (aerosols) (claim 24) (page 4, Lines 1-2). Leguminous plants that are produced from soybean seeds (genus Glycine sp.) (claims 36, 37, 38 ) were inoculated with a rhizobial culture solution (page 6, paragraph 7); and the strain was able to support increased nodulation, nitrogen-fixing, and growth at 20°C or less (claims 41 and 42) (page 2, paragraph 1-2). Regarding whole genome identity and/or 16S rRNA sequence analysis as further stated in the claims: Naoko, O et al., recites B. japonicum strain GEM96 with 100% sequence identity with 16S rRNA (SEQ ID. NO. 5). Naoko, O et al., discloses whole genome extraction of strain GEM96 and sequencing analysis was performed on 16S rRNA (page 6, paragraph 1), where GEM96 has 100% sequencing identity to SEQ ID. NO. 1 of the instant application (claims 27-29, 39, and 40).
Dependent claims 30-35 recite intended use and/or natural characteristics of the B. japonicum strain. Since the prior art teaches the claimed composition, which for the reasons discussed above, is the same as the instantly claimed strain, the prior art will be capable of performing the intended use and/or provide the same growth characteristics as described, since the organisms are: (1) the same B. japonicum, with (2) the same growth characteristics on the same media(s) at the same temperatures, that are (3) applied to the same leguminous plants that are soybean (genus Glycine), and as a (4) sprayable formulation, to perform the same intended use.
Naoko, O et al., does not specify Bradyrhizobium japonicum LMG P-32018. Note, since the USPTO is not equipped to make physical comparisons, a reasonable rationale is provided as to why the claimed strain is considered to be the same. The broadest reasonable interpretation of the claims recites a method to increase soybean growth and enhance characteristics such as root nodulation, nitrogen-fixation, and growth at temperatures between 10-25°C, with Bradyrhizobium japonicum that is coated onto seeds and applied as a sprayable formulation, and while also having 100% sequence identity to 16S rRNA.
Alternatively, if the prior art and the instant strain are not the same, it would have been obvious to one of ordinary skill in the art at the effective date of filing to modify the teachings of Naoko, O et al., and utilize obvious variant strain(s). Since Naoko, O et al., teaches a method with a composition that contains Bradyrhizobium japonicum and the same beneficial improvements to soybean growth characteristics it would be prima facie obvious to substitute Bradyrhizobium japonicum LMG P-32018 in place of Bradyrhizobium japonicum GEM96 to successfully produce the same outcome described in the instant application.
The motivation to use an alternative strain of Bradyrhizobium japonicum amounts to the simple substitution of functional equivalents, wherein substitution of one know strain(s) for another would have been obvious based on the shared functional properties, discussed previously; therefore Naoko, O et al., is considered to anticipate the claimed strain(s). One would have reasonable expected success since both strains are taught to share the same properties. The outcome of this modification would be to enhance growth characteristics of leguminous plants, as disclosed by the prior art.
Such a substitution would provide the same inoculation, nodulation nitrogen-fixation, and plant growth effects because both strains are Bradyrhizobium japonicum strains used for the same agricultural purpose.
Since the prior art teaches Bradyrhizobium japonicum LMG P-32018 which for the reasons discussed above is the same as the instantly claimed strain or an obvious variant, the prior art will be capable of performing the intended use. Assuming arguendo, applicant demonstrates the strain(s) are structurally different, the methods of use for Bradyrhizobium japonicum and the plant growth medium, described previously, would have the same ability to improve soybean growth characteristics, and the intended use would be the same.
Conclusion
No claims are deemed patentable.
Correspondence Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ENUSHA KARUNASENA whose telephone number is (571)272-3972. The examiner can normally be reached Monday-Friday 7:30am-5pm.
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/ENUSHA KARUNASENA/Examiner, Art Unit 1653
/JENNIFER M.H. TICHY/Primary Examiner, Art Unit 1653
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