DETAILED CORRESPONDENCE
Status of the Application
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-6 are pending in the application and are being examined on the merits.
Priority
This application is filed under 5 U.S.C. 120 as a continuation application of international application PCT/CN2021/139199, filed December 17, 2021, which claims foreign priority under 35 U.S.C. 119(a)-(e) to Chinese application no. 202110200261.8, filed February 23, 2021.
A certified copy of the foreign priority document has been received in this application on September 25, 2023. Should applicant desire to obtain the benefit of the filing date of the foreign priority application, a certified English translation of the application must be submitted. Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on August 15, 2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS has been considered by the examiner.
Foreign patent document citation no. 6 is lined through because there is no concise explanation of the relevance, as it is presently understood by the individual designated in 37 CFR 1.56(c) most knowledgeable about the content of the information, of each reference listed that is not in the English language. See 37 CFR 1.98(a)(3)(i).
Claim Objections
Claims 1-6 are objected to because of the following informalities:
Claim 1 is objected to and in the interest of improving claim form, it is suggested that the claim be amended to recite “Bacillus subtilis SK01 deposited at the China Center for Type Culture Collection (CCTCC) with the deposit number CCTCC M2020812.”
Claim 2 is objected to and in the interest of improving claim form, it is suggested that the claim be amended to recite “A microparticle capsule comprising the Bacillus subtilis SK01 of claim 1 coated with a coating consisting of lactic acid and methyl silicone oil or a coating consisting of chitosan and methyl silicone oil.”
Claim 3 is objected to and in the interest of improving claim form, it is suggested that the claim be amended to recite “The microparticle capsule of claim 2, wherein the microparticle capsule is a dry solid, and wherein the weight percent of the total weight of the dry solid for each component is 49-53% of the Bacillus subtilis SK01, 45-47% of the lactic acid or chitosan, and 1-4% of the methyl silicone oil of the total weight of the dry solid.”
Claim 4 is objected to and in the interest of improving claim form, it is suggested that the claim be amended to recite “A biodegradable plastic masterbatch produced by mixing and granulating the Bacillus subtilis microparticle capsule of claim 2, polyolefin, calcium carbonate, dispersant and zinc stearate.”
Claim 5 is objected to and in the interest of improving claim form, it is suggested that the claim be amended to recite “A biodegradable plastic masterbatch produced by mixing and granulating the Bacillus subtilis microparticle capsule of claim 3, polyolefin, calcium carbonate, dispersant and zinc stearate.
Claim 6 is objected to and in the interest of improving claim form, it is suggested that the claim be amended to recite “The biodegradable plastic masterbatch of claim 4, wherein the biodegradable plastic masterbatch is a dry solid, and wherein the weight percent of the total weight of the dry solid for each component is 0.3-1% of Bacillus subtilis microparticle capsule, 12-16% of polyolefin, 80-87% of calcium carbonate, 2% of dispersant, and 1% of zinc stearate.”
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.
Claims 4-6 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 4 (claim 6 dependent therefrom) recites the limitation "the bacillus subtilis microparticle capsule, polyolefin, calcium carbonate, dispersant and zinc stearate according to the claims 2.” There is insufficient antecedent basis for this limitation in the claim because claim 2 does not recite polyolefin, calcium carbonate, dispersant and zinc stearate as a component of the microparticle capsule. Applicant may consider amending claim 4 to recite “A biodegradable plastic masterbatch produced by mixing and granulating the Bacillus subtilis microparticle capsule of claim 2, polyolefin, calcium carbonate, dispersant and zinc stearate.”
Similarly, claim 5 recites the limitation "the bacillus subtilis microparticle capsule, polyolefin, calcium carbonate, dispersant and zinc stearate according to the claims 3.” There is insufficient antecedent basis for this limitation in the claim because claim 3 does not recite polyolefin, calcium carbonate, dispersant and zinc stearate as a component of the microparticle capsule. Applicant may consider amending claim 5 to recite “A biodegradable plastic masterbatch produced by mixing and granulating the Bacillus subtilis microparticle capsule of claim 3, polyolefin, calcium carbonate, dispersant and zinc stearate.”
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.
Claims 1-6 are rejected under 35 U.S.C. 112(a) 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 claims are drawn to or recite Bacillus subtilis SK01. Since the Bacillus subtilis SK01 is essential to the claimed invention, it must be obtainable by a repeatable method set forth in the specification or otherwise be readily available to the public. In this case, the specification does not disclose a repeatable process to obtain Bacillus subtilis SK01 and it is not apparent if the Bacillus subtilis SK01 is readily available to the public. Accordingly, it is deemed that a deposit of this bacterium should have been made in accordance with 37 CFR 1.801-1.809 and the enablement requirements of 35 U.S.C. § 112 may be satisfied by a deposit of Bacillus subtilis SK01.
If the strain has been deposited and accepted under the terms of 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 and accepted under the Budapest Treaty and that the strain will be irrevocably and without restriction or condition released to the public upon the issuance of the patent, would satisfy the deposit requirement made herein.
If the strain has been deposited, but not under the terms of the Budapest treaty, then in order to certify that the deposit meets the criteria set forth in 37 CFR 1.801-1.809, applicant may provide assurance or compliance by an affidavit or declaration, or by a statement by an attorney of record over his or her signature and registration number, including:
A statement that a deposit of the material has been made in a depository affording permanence of the deposit and ready accessibility thereto by the public if a patent is granted. The depository is to be identified by name and address.
A statement of the name and address of the depositor.
A statement of the date of deposit.
A statement that the deposited material has been accorded a specific (recited) accession number given by the depository.
A viability statement in accordance with 37 CFR 1.807(a) including the date of the viability test, the procedures used to obtain a sample if the test is not done by the depository, and a statement that the deposit is capable of reproduction.
A statement that all restrictions upon the availability to the public of the material so deposited will be irrevocably removed upon the granting of a patent.
A statement that the material has been deposited under conditions that access to the material will be available during the pendency of the patent application to one determined by the Commissioner to be entitled thereto under 37 CFR 1.14 and 35 U.S.C § 122.
A statement that the deposited material will be maintained with all the care necessary to keep it viable and uncontaminated for a period of at least five years after the most recent request for the furnishing of a sample of the deposited microorganism, and in any case, for a period of at least thirty (30) years after the date of deposit for the enforceable life of the patent, whichever period is longer.
That he/she declares further that all statements made therein of his/her own knowledge are true and that all statements made on information and belief are believed to be true, and further that these statements were made with knowledge that willful false statements and the like so made are punishable by fine or imprisonment, or both, under section 1001 of Title 18 of the United States Code and that such willful false statements may jeopardize the validity of the instant patent application or any patent issuing thereon.
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 1-3 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Applicant’s attention is directed to the "Guidance for Determining Subject Matter Eligibility Of Claims Reciting Or Involving Laws of Nature, Natural Phenomena, & Natural Products”, released on December 16, 2014.
Claim 1
Claim Interpretation: Claim 1 is drawn to Bacillus subtilis SK01, collected by China Center for Type Culture Collection CCTCC NO: M2020812.
According to the specification, the Bacillus subtilis SK01 was taken from dry rice straw (paragraph [0049]).
Given a broadest reasonable interpretation, claim 1 encompasses a naturally-occurring Bacillus subtilis bacterium.
Patent Eligibility Analysis Step 1: The claim is drawn to a composition of matter, which is one of the statutory categories of invention.
Patent Eligibility Analysis Step 2A Prong 1: The claim recites a naturally occurring bacterium, which is considered to be a law of nature or a natural phenomenon (a natural product). The Bacillus subtilis SK01 of claim 1 is not considered to have markedly different characteristics from what occurs in nature, and is considered to be a “product of nature” exception. Accordingly, claim 1 is directed to a judicial exception.
Patent Eligibility Analysis Step 2A Prong 2: There are no additional elements recited in the claim beyond the judicial exception.
Patent Eligibility Analysis Step 2B: The claim only recites the product of nature, without more and does not include any additional elements that could add significantly more to the judicial exception.
As such, claim 1 does not qualify as eligible subject matter.
Claims 2-3
Claim Interpretation: Claims 2-3 are drawn to a microparticle capsule of Bacillus subtilis, wherein a coat for Bacillus subtilis SK01 according to the claim 1, which consists of lactic acid or chitosan and methyl silicone oil.
Given a broadest reasonable interpretation, claims 2-3 encompass a combination of naturally occurring components – a naturally-occurring bacterium and lactic acid.
Patent Eligibility Analysis Step 1: The claims are drawn to a composition of matter, which is one of the statutory categories of invention.
Patent Eligibility Analysis Step 2A Prong 1: The claims recite a combination of naturally occurring components, which is considered to be a law of nature or a natural phenomenon (a natural product). There is no evidence of record of a naturally occurring counterpart to the claimed combination, so the combination is compared to the individual components as they occur in nature (see MPEP 2106.04(c).II.A). There is no indication in the specification or evidence of record that the combination of components has any characteristics (structural, functional, or otherwise) that are different from the corresponding individual components as each occurs in nature. Furthermore, there is no indication in the specification or evidence of record that combining these components changes the structure, function, or other properties of the naturally occurring components. In other words, the overall combination of components does not render the resulting composition different from each of the individual components. Thus, the microparticle capsule of claims 2-3 is not considered to have markedly different characteristics from what occurs in nature, and is considered to be a “product of nature” exception. Accordingly, the microparticle capsule of claims 2-3 is directed to a judicial exception.
Patent Eligibility Analysis Step 2A Prong 2: There are no additional elements recited in the claims beyond the judicial exception.
Patent Eligibility Analysis Step 2B: The claims only recite the products of nature, without more and do not include any additional elements that could add significantly more to the judicial exception.
As such, the claims do not qualify as eligible subject matter.
For these reasons the claims are rejected under section 101 as being directed to non-statutory subject matter.
Allowable Subject Matter
The closest prior art of record is considered to be Wu et al. (CN 112375720 A; cited on the IDS filed August 15, 2023) disclosing a Bacillus subtilis WS1811 bacterium isolated from river sludge for degradation of water-based polyurethane. The prior art of record does not teach or suggest Bacillus subtilis SK01. Therefore, the Bacillus subtilis SK01, microparticle capsule, and biodegradable plastic masterbatch of claims 1-6 are free of the prior art of record.
Conclusion
Status of the claims:
Claims 1-6 are pending.
Claims 1-6 are rejected.
No claim is in condition for allowance.
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/David Steadman/Primary Examiner, Art Unit 1656