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 .
The response filed May 12, 2026, has been received and entered.
Claims 1-12 are pending.
Election/Restrictions
Applicant’s election of Group I, claims 1-9 and 11, in the reply filed on May 12, 2026, is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 10 and 12 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim.
Claims 1-9 and 11 are examined on the merits.
Claim Objections
Claims 1-9 and 11 are objected to because of the following informalities:
Claims 1-9 and 11 recite the genus name “Streptomyces” without italicization. Every recitation of “Streptomyces” should be italicized.
Claim 4 is objected to because the full name corresponding to the abbreviation “IAA” should be recited. The abbreviation “IAA” is known in the technical field of the claimed invention as corresponding to “indole-3-acetic acid,” which is also known as “indole acetic acid.” See the abstract of Chouyia (Frontiers in Plant Science. 2020. 11:1137. 10 pages) and the abstract of Gopalakrishnan 2014 (Microbiological Research. 2014. 169: 40-48).
Claims 5-7 are objected to because of the comma after the recitation “wherein” in line 2 of each claim. The comma should be deleted for proper grammar.
Appropriate correction is required.
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 5-7 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.
The term “grow well” in claim 5 is a relative term which renders the claim indefinite. The term “grow well” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear what level of growth is required for the Streptomyces sp. CS13-6 to be considered as growing “well.” The term “grow well” is a subjective term that renders the claim indefinite; see MPEP 2173.05(b)(IV). For the purpose of applying prior art, growth in the initial culture medium with pH 5-10 is being interpreted as meeting the claimed term of “grow well.”
Also, the term “high acid and alkali resistance” in claim 5 is a relative term which renders the claim indefinite. The term “high acid and alkali resistance” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear what level of acid and alkali resistance is required for it to be considered “high.” For the purpose of applying prior art, any acid and alkali resistance is being interpreted as meeting the claimed term “high acid and alkali resistance.”
The term “grow well” in claim 6 is a relative term which renders the claim indefinite. The term “grow well” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear what level of growth is required for the Streptomyces sp. CS13-6 to be considered as growing “well.” The term “grow well” is a subjective term that renders the claim indefinite; see MPEP 2173.05(b)(IV). For the purpose of applying prior art, growth at 20-40ºC is being interpreted as meeting the claimed term of “grow well” at 20-40ºC.
Also, the term “wide temperature adaptability” in claim 6 is a relative term which renders the claim indefinite. The term “wide temperature adaptability” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear what level of temperature adaptability is required for it to be considered “wide.” The scope of the term “wide temperature adaptability” is unclear.
Claim 7 is indefinite because it is unclear what is meant by “grow normally.” It is unclear what would be considered a ‘normal’ growth. The specification as filed does not define “grow normally.’ It is unclear what type and level of growth is required for the Streptomyces sp. CS13-6 to be considered as growing “normally.” For the purpose of applying prior art, growth when the NaCl content is 4% is being interpreted as meeting the claimed term of “grow normally” when the NaCl content is 4%.
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 1-9 and 11 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.
The microorganism Streptomyces sp. CS13-6 is recited in the claims, and thus is essential to the claimed invention. Since the microorganism is essential to the claimed invention, it must be obtainable by a repeatable method set forth in the specification or otherwise readily available to the public. If the microorganism is not so obtainable or available, the requirements of 35 U.S.C. § 112 may be satisfied by a deposit of the biological material.
The specification does not disclose a repeatable process to obtain the microorganism, and it is not apparent if the biological material is readily available to the public. It noted that the deposit information for the microorganism is on page 2, lines 14-17 and page 5, lines 21-25 of the originally filed specification, but there is no indication in the specification as to public availability of the strain.
If the deposit is made under the Budapest Treaty, then an affidavit or declaration by applicant, or a statement by an attorney of record over his or her signature and registration number, stating that the specific strain has been deposited under the Budapest Treaty and that the specific strain will be irrevocably and without restriction or condition released to the public upon the issuance of a patent, would satisfy the deposit requirement 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 may 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.
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 1-8 and 11 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon without significantly more.
The claims have been analyzed for eligibility in accordance with their broadest reasonable interpretation. The claims are directed to a statutory category, i.e. a composition of matter (Step 1: YES).
Claim 1: Claim 1 recites the Streptomyces sp. CS13-6 strain. The instant specification indicates that the strain was isolated from tailing sand samples of an iron mine in China (page 4, lines 4-5). Since the CS13-6 strain was obtained from a natural source, then the strain is naturally occurring.
Claim 1 further recites that the strain is “silicate solubilizing.” This is a property inherent in the CS13-6 strain. This is evidenced by Example 2 of the specification in which silicate solubilization was determined as a feature of the CS13-6 strain (page 5, line 26 through page 6, line 12). Accordingly, the claimed silicate solubilizing Streptomyces sp. CS13-6 is a naturally occurring product, signifying that claim 1 recites a ‘product of nature’ exception (Step 2A, Prong One: YES).
This judicial exception is not integrated into a practical application. Claim 1 only recites the judicial exception (a silicate solubilizing Streptomyces sp. CS13-6) which is a product of nature. Thus claim 1 does not recite any ‘additional element’ other than the judicial exception that integrates the judicial exception into a practical application (Step 2A, Prong Two: NO). As such, claim 1 is directed to a judicial exception (Step 2A: YES).
Claim 1 does not include additional elements that are sufficient to amount to significantly more than the judicial exception because claim 1 does not recite any ‘additional element’ other than the judicial exception (Step 2B: NO). Accordingly, claim 1 is not eligible subject matter under 35 U.S.C. 101.
Claims 2-8: Claim 2-8 each recite properties of the CS13-6 strain. These are properties are inherent in the CS13-6 strain. Therefore, claims 2-8 are rejected under the same basis as parent claim 1.
Claim 11: Claim 11 recites a composition comprising the silicate solubilizing Streptomyces sp. CS13-6 according to claim 1 as an active ingredient. As discussed above with respect to claim 1, the silicate solubilizing Streptomyces sp. CS13-6 is a product of nature. Accordingly, a composition comprising the CS13-6 strain is nature-based composition.
Under Step 2A, Prong One of the analysis, the claimed nature-based composition is compared to its naturally occurring counterpart in its natural state to identify markedly different characteristics based on structure, function, and/or other properties. Claim 11 recites that the composition is a bio-silicon fertilizer and/or a soil conditioner composition. The specification does not require that the bio-silicon fertilizer comprises a silicon. Instead, a bio-silicon fertilizer (i.e. biological silicon fertilizer as in the abstract) is produced by using the CS13-6 strain as an active ingredient (page 3, lines 5-6). Furthermore, the CS13-6 strain produces the silicon through its silicate solubilizing capability. See page 4, lines 15-18 and Example 2 (page 5, line 26 through page 6, line 12) of the specification. Thus, the “bio-silicon fertilizer” limitation is an inherent property of the CS13-6 strain, particularly since the CS13-6 strain is recited as the active ingredient. Moreover, the recitations of a ‘fertilizer’ and a ‘soil conditioner’ composition are directed to the intended use(s) of the composition. Therefore, the limitations of a “bio-silicon fertilizer” and/or a “soil conditioner composition” do not set forth any markedly different characteristic of the claimed composition as compared to its naturally occurring counterpart (a composition comprising the CS13-6 strain). Accordingly, claim 11 recites a ‘product of nature’ exception (Step 2A, Prong One: YES).
This judicial exception is not integrated into a practical application. The recitation of the intended use of the composition (bio-silicon fertilizer and/or soil conditioner) is the ‘additional element’ of the claim other than the judicial exception. The intended use does not integrate the claimed product of nature into a practical application since it does not require that the intended use is performed as claim 11 recites a product rather than a process. Accordingly, the ‘additional element’ recited in claim 11 does not integrate the product of nature into a practical application (Step 2A, Prong Two: NO). Therefore, claim 11 is directed to a judicial exception (Step 2A: YES).
Claim 11 does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As pointed out above, the ‘additional element’ other than the judicial exception (the product of nature) is the intended use of the composition (as set forth by the recitations of “bio-silicon fertilizer” and “soil conditioner”). The intended use corresponds to properties inherently possessed by the CS13-6 strain, and thus does not amount to significantly more than the judicial exception. As such, the additional element recited in claim 11 does not amount to significantly more than the claimed judicial exception (Step 2B: NO). Accordingly, claim 11 is not eligible subject matter under 35 U.S.C. 101.
Relevant Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Chouyia (Frontiers in Plant Science. 2020. 11: 1137. 10 pages) discloses Streptomyces roseocinereus MS1B15 as a phosphate-solubilizing bacteria (abstract). Additionally, the MS1B15 strain possesses plant growth-promoting traits which include production of siderophores and indole-3-acetic acid (IAA), and nitrogen fixation (abstract). Therefore, the MS1B15 strain shares at least the following properties with the claimed Streptomyces sp. CS13-6: a Streptomyces microorganism, capability of dissolving phosphorus (instant claims 3 and 8), fixing nitrogen (instant claims 3 and 8), siderophore and IAA production capability (instant claim 4), and promoting plant growth (instant claim 9). However, there is insufficient evidence to support a conclusion that the MS1B15 strain of Chouyia is the claimed CS13-6 strain. Furthermore, the MS1B15 strain of Chouyia was isolated from Moroccan oat rhizosphere (abstract) whereas the claimed CS13-6 strain was isolated from the tailing sand samples of an iron mine in Chengde, Hebei Province, China (page 4, lines 3-6 of the instant specification). Moreover, the claimed CS13-6 strain is closest to Streptomyces regalis in taxonomy (page 5, lines 12-13 of the specification) whereas the MS1B15 strain is a Streptomyces roseocinereus strain.
Gopalakrishnan 2014 (Microbiological Research. 2014. 169: 40-48) discloses Streptomyces sp. strain KAI-180 which has in vitro plant growth-promoting properties (abstract). Additionally, the KAI-180 strain produces indole acetic acid (IAA) (abstract). The KAI-180 strain also has good growth at 20, 30, and 40ºC (Table 1 on page 44). According to Gopalakrishnan 2022 (3 Biotech. 2022. 12: 318. 11 pages. Published online October 10, 2022), the KAI-180 strain is capable of solubilizing silica (abstract) as determined by using a silicate medium for growing the strain (page 2, right column, first paragraph). Therefore, the KAI-180 strain shares at least the following properties with the claimed CS13-6 strain: a Streptomyces microorganism, silicate solubilizing capability, IAA production capability (instant claim 4), growth at 20-40ºC (instant claim 6), and promoting plant growth (instant claim 9). However, there is insufficient evidence to support a conclusion that the KAI-180 strain of the Gopalakrishnan references is the claimed CS13-6 strain. Furthermore, the KAI-180 strain differs from the claimed CS13-6 strain in that the KAI-180 strain does not grow at pH 5 (see Table 1 on page 44 of Gopalakrishnan 2014, and page 7, line 12 of the instant specification) and the KAI-180 strain was isolated from the botanical Oryza sativa (page 41, left column, first full paragraph and page 42, right column, last full paragraph of Gopalakrishnan 2014) whereas the claimed CS13-6 strain was isolated from the tailing sand samples of an iron mine in Chengde, Hebei Province, China (page 4, lines 3-6 of the instant specification).
Conclusion
No claims are allowed.
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Sef
/SUSAN E. FERNANDEZ/Examiner, Art Unit 1651
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