DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Status of the Claims
Claims 1-12 are pending and under consideration in this action.
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 11 and 12 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a natural phenomenon) without significantly more. Claim 11 recites a strain of Mitsuaria noduli deposited at the CNCM on July 30, 2021, under the number I-5724 or I-5725, and claim 12 recites a composition comprising at least one strain as defined in claim 11.
As evidenced by Fan et al. (Int J Syst Evol Microbiol; published 2018), Mitsuaria noduli is a naturally occurring strain known to be found on the root nodules of Robinia pseudoacacia growing in a lead-zinc mine in Mianxian County, Shaanxi, China (abstract). There is no indication in the Specification that the claimed deposited strains of Mitsuaria noduli has any characteristics (structural, functional, or otherwise) that are different from its naturally occurring counterpart, or that is was modified in any way from its naturally occurring counterpart. Thus, the specific deposited strain does not have markedly different characteristics from what occurs in nature, and is a “product of nature” exception. The claims do not include any additional features that could add significantly more to the exception.
Claims 9 and 10 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because both claims are “use” claims. As noted in MPEP 2173.05(q): “Use” claims that do not purport to claim a process, machine, manufacture, or composition of matter fail to comply with 35 U.S.C. 101. In re Moreton, 288 F.2d 708, 709, 129 USPQ 227, 228 (CCPA 1961)(“one cannot claim a new use per se, because it is not among the categories of patentable inventions specified in 35 U.S.C. § 101”).
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 2 and 10-12 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.
Claims 2, 10, and 11 recite deposit numbers of strains of Mitsuaria noduli. Claim 12 incorporates claim 11 and therefore also incorporates limitations of the aforementioned deposit numbers. If the deposit is made under the terms of the Budapest Treaty, then an affidavit or declaration by Applicants, or a statement by an attorney of record over his or her signature and registration number, or someone empowered to make such a statement, stating that the instant invention will be irrevocably and without restriction released to the public upon issuance of a patent, would satisfy the deposit requirement made herein. In instances where the claimed invention consists of sexually unstable material a deposit of the parental material is required if the parental material is considered sexually stable.
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 CFR 1.801-1.809 and MPEP 2402-2411.05, Applicant may provide assurance of compliance by affidavit or declaration, or by someone empowered to make the same, or by a statement by an attorney of record over his or her signature and registration number showing that:
during the pendency of the application, access to the invention will be afforded to the Commissioner upon request;
all restrictions upon availability to the public will be irrevocably removed upon granting of the patent;
the deposit will be maintained in a public depository for a period of 30 years, or after 5 years after the last request or for the enforceable life of the patent, whichever is longer;
a test of the viability of the biological material at the time of deposit (see 37 CFR 1.807); and the deposit will be replaced if it should ever become inviable.
If the deposit(s) was/were made after the effective filing date of the application for a patent in the United States, a verified statement is required from a person in a position to corroborate that the strains described in the specification as filed are the same as that deposited in the depository. Corroboration may take the form of a showing of a chain of custody from applicant to the depository coupled with corroboration that the deposit is identical to the biological material described in the specification and in the applicant’s possession at the time the application was filed.
Applicant has not provided clear evidence that the Deposit has been "made and accepted" under the Budapest Treaty. Thus, the subject matter was not described in the specification in such a way to enable one skilled in the art to make and use the invention without undue experimentation.
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 3-10 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.
With regards to Claim 3, the term “typically” renders the claim indefinite because it is unclear whether the claimed elements following the term are required or optional.
With regards to Claims 4-8, each of the claims recite “aims to improve”. The phrase renders each of the claims unclear as to what the scope of the claims are. In particular, as the claims are directed to methods claims, it is unclear if the action following the phrase must be achieved in order to read on the claim, or if merely the application to the target plant is sufficient to read on the claim, regardless of whether or not the claimed action (e.g., improved yield in the case of claim 5) is achieved.
With regards to Claims 9 and 10, both are directed to the “use” of the claimed bacterial strain and do not set forth any steps involved in the method/process, and thus it is unclear what method/process they are intended to encompass. A claim is indefinite where it merely recites a use without any active, positive steps delineating how the use is actually practiced.
Claim Rejections - 35 USC § 103
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 3, and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Shimizu et al. (Shimizu) (US 2020/0359635 A1; published Nov. 19, 2020) and Fan et al. (Int J Syst Evol Microbiol; published 2018).
Shimizu is directed to bacterial strains of genus Mitsuaria, and to bacterial plant disease control agents and plant growth regulators using such strains (para.0001).
With regards to Claims 1 and 9, Shimizu discloses a method for regulating plant growth, comprising the step of contacting viable bacteria of a strain belonging to genus Mitsuaria and having a bacterial plant disease control effect, such as Mitsuaria chitosanitabida, to a plant and/or a soil (para.0013, 0014, 0024).
Compositions comprising the Mitsuaria strain may be sprayed against crops, seeds, and onto soil (para.0067).
With regards to Claim 3, the concentration of viable bacteria contained in a bacterial plant disease control agent is not particularly limited as long as the bacterial plant disease control agent can produce the desired effect. However, because a bacterial concentration that is too low often fails to produce sufficient results, and a bacterial concentration that is too high is wasteful of bacteria, the bacterial concentration is appropriately adjusted in a range of 1x105 to 1x1010 CFU/ml in the case of, for example, a liquid preparation (para.0063).
Shimizu does not appear to explicitly disclose wherein the bacterial strain is the species Mitsuaria noduli. Fan is relied upon for this disclosure. The teachings of Fan are set forth herein below.
Fan discloses a novel endophytic bacterium, designated strain HZ7 (Mitsuaria noduli), which was isolated from the root nodules of Robinia pseudoacacia growing in a lead-zinc mine in Mianxian County, Shaanxi, China. Mitsuaria noduli was found to be a close phylogenetic relative of Mitsuaria chitosanitabida 3001 (99.05% similarity) (abstract).
Fan discloses that the genus contains Gram-negative, obligately aerobic, oxidase- and catalase-positive and chitosanase-producing bacteria. The genus Mitsuaria has increasingly been considered as an important source of chitosanase. Chitosanase can hydrolyze chitosan into different-length chitosan oligosaccharides and plays a role in morphogenesis and/or autolysis in chitin-containing organisms such as fungi, insects ,and crustaceans. The chitosan oligosaccharides have been reported to possess several important biological properties, including antifungal and antibacterial activities (p.87, col.1, para.1).
Mitsuaria noduli was found to be positive for catalase- and chitosan-degrading activity (p.91, col.1, para.1).
As discussed above, Shimizu discloses a method for regulating plant growth, comprising the step of contacting viable bacteria of a strain belonging to genus Mitsuaria and having a bacterial plant disease control effect, such as Mitsuaria chitosanitabida, to a plant and/or a soil. In light of Fan’s disclosure that Mitsuaria noduli is a close phylogenic relative of Mitsuaria chitosanitabida and was also found to also have chitosan-degrading activity, which ultimately plays an antifungal and antibacterial role, one of ordinary skill in the art would have found it prima facie obvious before the effective filing date of the instant invention to combine the teachings of Shimizu with the teachings of Fan and try Fan’s Mitsuaria noduli as the Mitsuaria genus bacterial strain, either in addition to or in lieu of Shimizu’s Mitsuaria chitosanitabida, to spray onto crops, seeds, or soil to regulate the growth of the plant and control bacterial plant disease. One of ordinary skill in the art would been motivated to do so Mitsuaria noduli was found to be a close phylogenetic relative of Mitsuaria chitosanitabida, and was found to also have chitosan-degrading activity, which would suggest Mitsuaria noduli would ultimately also provide antifungal and antibacterial activities. One of ordinary skill in the art would have had a reasonable expectation of success in doing so as Shimizu discloses the application of Mitsuaria genus bacterial strain, and Fan discloses that Mitsuaria noduli is a close phylogenetic relative to Mitsuaria chitosanitabida and possesses chitosan-degrading activity.
Therefore, the claimed invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention, because the combined teachings of the prior art references is fairly suggestive of the claimed invention.
Claims 5-8 are rejected under 35 U.S.C. 103 as being unpatentable over Shimizu et al. (Shimizu) (US 2020/0359635 A1; published Nov. 19, 2020) and Fan et al. (Int J Syst Evol Microbiol; published 2018) as applied to Claims 1, 3, and 9 set forth above, further in view of Shimizu et al. (Shimizu 2024) (US 2024/0196907 A1; priority date: May 31, 2021).
The teachings of Shimizu and Fan and the motivation for their combination as they apply to Claims 1, 3, and 9 are set forth above and incorporated herein.
The combined teachings of Shimizu and Fan do not appear to explicitly disclose application of the composition to strawberries (Claims 5 and 6), sunflowers (Claim 7), or rapeseed (Claims 5 and 8). Shimizu 2024 is relied upon for this disclosure. The teachings of Shimizu 2024 are set forth herein below.
Shimizu 2024 discloses a bacterial strain of genus Lysinibacillus having a plant growth promoting effect and use thereof (para.0001). Shimizu 2024 provides a material that can contribute to crop production by increasing profit with its plant growth regulatory effect while reducing loss by controlling disease (para.0041).
The Lysinibacillus may be used in combination with other agrichemicals, such as germicides and plant growth regulators. Among the suitable germicidal active components or disease control agents that may be used in combination with the Lysinibacillus strain includes Mitsuaria chitosanitabida (para.0094-0096).
Shimizu 2024’s material may be applied to plants, such as strawberries, rapeseed, and common sunflower (para.0090).
With regards to the particular target crops as recited in Claims 5-8, as discussed above, Shimizu discloses that their compositions comprising a Mitsuaria genus bacterial strain may be applied to crops. One of ordinary skill in the art would have found it prima facie obvious before the effective filing date of the instant invention to further combine the teachings of Shimizu and Fan with the teachings of Shimizu 2024 and try spraying the composition of the combined teachings of Shimizu and Fan onto strawberries, rapeseed, or sunflowers. One of ordinary skill in the art would have been motivated so do so in order to provide such crops with plant growth promoting effects. One of ordinary skill in the art would have had a reasonable expectation of success in doing so Shimizu discloses that application of Mitsuaria genus bacterial strains on crops, and Shimizu 2024 discloses that bacterial plant growth regulators, including Mitsuaria genus bacteria, are known to be applied to strawberries, rapeseed, and sunflowers.
Therefore, the claimed invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention, because the combined teachings of the prior art references is fairly suggestive of the claimed invention.
Conclusion
Claims 1-12 are rejected. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MONICA A. SHIN whose telephone number is (571)272-7138. The examiner can normally be reached Monday-Friday (9:00AM-5:00PM EST).
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/MONICA A SHIN/Primary Examiner, Art Unit 1616