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 Status
The amended claim set filed on 25 August 2025 is acknowledged. Claims 2-9 and 11-22 are currently pending. Of those, claims 2, 6-7, and 9 are amended. Claims 11-22 are new, and claims 1 and 10 are cancelled. Claims 2-9 and 11-22 will be examined on the merits herein.
Priority
The instant application claims priority to foreign application CN 202210770685.2 (filed 30 June 2022). Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. However, because no certified translation of the foreign priority document was provided, the foreign priority claim has not been perfected. Therefore, for the purposes of searching the prior art, the effective filing date of instant claims 2-9 and 11-22 is 26 September 2022.
Claim Objections
Claims 2-9, 11-15, and 17-22 are objected to because of the following informalities: The bacteria name “Bacillus subtilis” and the gene names “zwf”, “ywlf”, “ribBA”, “pgi”, and “purR” should be italicized. Appropriate correction is required.
Claim Interpretation
Regarding claim 2, the claim recites: “a. an original plasmid of the recombinant plasmid is preferably pMA5-sat; b. the zwf gene, the ywlf gene, and the ribBA gene are preferably ligated to the original plasmid in a homologous recombination manner”. MPEP 2111.04 states: “Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure.” Therefore, these preferable limitations are interpreted as not being required by the claim.
Claim Rejections - 35 USC § 112(b)
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 2-9 and 11-22 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.
Claim 2, upon which claims 3-9 and 11-22 depend, recites the phrase “using a Bacillus subtilis RF1-6 strain.” The term “using” implies an active method step being taken; however, the claim is drawn to “A recombinant Bacillus subtilis strain,” which is a product, not a method. Because the claim recites a process of making the claimed product, it is interpreted as a product-by-process claim. MPEP 2113(I) states: “The structure implied by the process steps should be considered when assessing the patentability of product-by-process claims over the prior art….” However, it is not clear what actions are encompassed by the phrase “using a Bacillus subtilis RF1-6 strain.” Because the phrase is not defined in the specification, the process of “using” a B. subtilis RF1-6 is indefinite and does not permit one of ordinary skill in the art to identify the step(s) used to make the recombinant B. subtilis strain and what structural features (if any) the process imparts to the claimed strain. From MPEP 2173.05(q): “Attempts to claim a process without setting forth any steps involved in the process generally raises an issue of indefiniteness under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph…because it merely recites a use without any active, positive steps delimiting how this use is actually practiced. Ex parte Erlich, 3 USPQ2d 1011 (Bd. Pat. App. & Inter. 1986).” Because the claim does not recite steps for the process of “using a Bacillus subtilis RF1-6 strain”, one of ordinary skill in the art could not determine how the process limits the structure of the claimed recombinant B. subtilis. In the interest of compact prosecution, the step of “using a Bacillus subtilis RF1-6 strain as an original strain” is interpreted as transforming B. subtilis RF1-6 (i.e., the host strain) with the claimed recombinant plasmid. Clarification is requested.
Claim 2 also recites, “the zwf gene, the ywlf gene, and the ribBA gene are preferably ligated to the original plasmid in a homologous recombination manner….” However, the phrase “homologous recombination manner” is not defined in the specification. Thus, it is unclear what is encompassed by the phrase and how it limits the structure of the recombinant B. subtilis. From MPEP 2173.05(a)(I): “The meaning of every term used in a claim should be apparent from the prior art or from the specification and drawings at the time the application is filed. Claim language may not be ‘ambiguous, vague, incoherent, opaque, or otherwise unclear in describing and defining the claimed invention.’ In re Packard, 751 F.3d 1307, 1311, 110 USPQ2d 1785, 1787 (Fed. Cir. 2014). Applicants need not confine themselves to the terminology used in the prior art, but are required to make clear and precise the terms that are used to define the invention whereby the metes and bounds of the claimed invention can be ascertained.” If the same structure can be produced by ligating the zwf, ywlf, and ribBA genes into the original plasmid by another process, then the claim is not limited to B. subtilis strains comprising the recombinant plasmid made by ligating the zwf, ywlf, and ribBA genes by homologous recombination. See MPEP 2113. Clarification is requested.
Claim 3 recites, “EcoRI and KpnI restriction sites of the recombinant plasmid….” There is insufficient antecedent basis for this limitation in the claim. The usage of “the recombinant plasmid” refers back to claim 2: “a recombinant plasmid, wherein a zwf gene, a ywlf gene, and a ribBA gene are inserted into the recombinant plasmid”. Claim 2 does not recite that the plasmid has EcoRI and KpnI restriction sites, and the plasmid of claim 2 is not limited by the preferable statement reciting a specific plasmid (see Claim Interpretation section above). MPEP 2173.05(e) states that “Inherent components of elements recited have antecedent basis in the recitation of the elements themselves”, but having these restriction sites is not defined in the specification as being an inherent feature of “a recombinant plasmid”. Therefore, one of ordinary skill in the art would not be able to clearly determine whether the recombinant plasmids in claim 2 are limited to those having EcoRI and KpnI restriction sites, or whether this is a newly introduced limitation on the recombinant plasmids of claim 3.Thus, in the interest of compact prosecution, claim 3 is interpreted as limiting the recombinant plasmid of claim 2 to plasmids containing EcoRI and KpnI sites, and the zwf, ywlf, and ribBA genes are inserted in sequence between those sites in the recombinant plasmid. Clarification is requested.
Claims 5 and 17 each recite, “wherein the strong promoter P43 in inserted at the EcoRI site in an upstream region of the zwf gene.” As written, it is unclear if claim requires the P43 promoter to be inserted into an upstream region of the zwf gene (i.e., inserted into the gene) or inserted in a region upstream of the zwf gene (i.e., not inserted into the gene). In the interest of compact prosecution, both interpretations will be searched in the prior art. Clarification is requested.
Claim 9 recites, “A microbial inoculant, comprising the Bacillus subtilis strain according to claim 2.” Claim 15 (upon which claims 16-22 depend) recites, “A microbial inoculant, comprising the Bacillus subtilis strain according to claim 3.” The instant specification does not specifically define the term “microbial inoculant”, but it is defined in the art as “bacteria, fungi, or other microorganisms, typically isolates, that are intentionally introduced to an environment to enhance a target function.” (See Kaminsky et al., 2019, Trends Biotechnol., pg. 2, “Glossary”) Based on this definition, it is unclear how claims 9 and 15 further limit the subject matter of claims 2 and 3, respectively, as it is unclear whether/how incorporating a bacterial strain into a “microbial inoculant” results in a structurally different product compared to said bacterial strain. Claims 16-17, 19-20, and 22, which depend upon claim 15, recite the same limitations to the microbial inoculant of claim 15 that claims 4-5, 11-12, and 13 (respectively) recite limiting the B. subtilis strain of claim 3. Note that if “microbial inoculant” is merely an intended use of the claimed B. subtilis strains, but does not further limit the structure of the recited B. subtilis strains, then, should claims 2-5 be found allowable, claims 9, 15-17, 19-20, and 22 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. Note also that claims 18 and 21 recite “microbial inoculants” having combinations of limitations found in “recombinant strain” claims 3-5 and 6-7 and may also become amended into substantial duplicates during the course of examination. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m) for the proper form of claims and MPEP § 2111.02 for the discussion of the effect of the preamble on claim interpretation. Clarification is requested.
Claim Rejections - 35 USC § 112(a)
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 2-9 and 11-22 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 Bacillus subtilis RF1-6 strain deposited at China Center for Type Culture Collection (CCTCC) under accession number M 2022565 and Bacillus subtilis RF1-6ZYRS strain deposited at CCTCC under accession number M 2022566 are required to practice the claimed invention (see claims 2 and 8, respectively). 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 Bacillus subtilis RF1-6 and RF1-6ZYRS strains.
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 materials considered necessary to make and use the invention is both known and readily available to the public. The specification teaches that the claimed Bacillus subtilis RF1-6 strain was produced by introducing the mutagenized plasmid pBT2-M4 (para. 52) into the riboflavin-producing B. subtilis RF1 containing a reporter plasmid (para. 53), followed by mutagenizing the cells by atmospheric room temperature plasma (para. 54). Mutagenesis by atmospheric room temperature plasma causes random mutations leading to DNA damage and a “high diversity of mutants” (see Wang et al., 2020, Sci. Rep., pg. 2, para. 2 and pg. 8, para. 3); thus, the process of producing B. subtilis RF1-6 cannot be replicated. The claimed Bacillus subtilis RF1-6ZYRS strain could not be reproduced without knowing the exact sequences of the zwf, ywlf, and ribBA genes inserted into the recombinant plasmid in B. subtilis. The instant specification does not teach the exact sequences or point to where the sequences are described in the art (such as a sequence accession number) and does not teach the bacterial source of the genes (i.e., are the genes B. subtilis genes or from another species, such as E. coli?). Thus, one of ordinary skill in the art would not be able to make the claimed recombinant B. subtilis strain or use it to make the microbial inoculants of claims 9 and 15-22.
It is noted that Applicants have deposited biological material but there is no indication in the specification as to public availability of either deposited strain.
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 requirement made herein.
If the deposit is a non-Budapest Treaty deposit, then in order to certify that the deposit meets the requirements set forth in 37 CFR 1.801-1.809 and MPEP 2402-2411.05, a statement, affidavit or declaration by Applicant 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 would satisfy the requirements herein by stating and providing that:
(a) During the pendency of the 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; and
(d) Provide evidence of the test of the viability of the biological material at the time of deposit (see 37 CFR 1.807).
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BAILEY M MORGAN whose telephone number is (703)756-5388. The examiner can normally be reached M-F 9-5 ET.
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/BAILEY M MORGAN/Examiner, Art Unit 1645
/VANESSA L. FORD/Supervisory Patent Examiner, Art Unit 1674