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 .
DETAILED ACTION
Application Status
This application is a Non-Provisional patent application filed on 06/23/2023.
Claims 1, 11-12, 13-16 and 17 are currently pending in the instant application.
The preliminary amendment filed on 06/23/2023, amending claim 1, canceling claims 2-10, and adding new claims 11-17 is acknowledged.
Election/Restriction
Applicant's election without traverse of Group I, Claims 1, 11 and 12, drawn to a microbial biological control agent (MBCA), comprising a Streptomyces ardesiacus HL-06, wherein the Streptomyces ardesiacus HL-06 has been deposited on June 9, 2022 in the China General Microbiological Culture Collection Center (CGMCC) at NO.1 West Beichen Road, Chaoyang District, Beijing 100101, with a deposit number of CGMCC No.25033 in the response filed on 04/10/2026 is acknowledged.
Claims 13-16 and 17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Applicants request for rejoinder is noted. However, current claims of elected Group I are not allowable at this time. When Group I would be allowable, rejoinder request would be evaluated at that time.
The requirement is still deemed proper and is therefore made FINAL.
Claims 1, 11 and 12 are present for examination.
Priority
Acknowledgement is made of applicants claim for foreign priority under 35 U.S.C. 119(a)-(d) to a foreign patent application CHINA 202210898538.3, filed on 07/28/2022 without English translation.
Information Disclosure Statement
There are no IDSs with this application.
Drawings Objections-Non-Compliance of Sequence Rule
The disclosure is objected to because of the following informalities:
2422.01-.04 The Requirement for Exclusive Conformance; Sequences Presented
in the Drawing Figures (see, Fig. 1. 37 CFR 1.821(b) requires….Any sequence more than 10 nucleotides or more than 3 amino acids, regardless of the format or the manner of presentation of that sequence in the Claims, Specification or Drawings the sequence must still be included in the Sequence Listing and the sequence identifier (“SEQ ID NO:X”) must be used (see, Fig. 1 in the Drawings). It should be noted, though, that when a sequence is presented in a drawing, regardless of the format or the manner of presentation of that sequence in the drawing, more than 10 nucleotides or more than 3 amino acids, regardless of the format or the manner of presentation of that sequence in the Claims, Specification or Drawing the sequence must still be included in the Sequence Listing and the sequence identifier (“SEQ ID NO:X”) must be used (see, Fig. 1 in the Drawings). See particularly 37 CFR 1.821(d).
Appropriate correction is required.
Drawings Objections
Drawings submitted on 06/23/2023 are not accepted by the Examiner because of Non-compliance of Sequence Rule and Fig. 1 of Drawings recite the nucleic acids sequence or amino acids sequence without a corresponding sequence identifier, i.e. SEQ ID NO:. See particularly 37 CFR 1.821(d). Applicants are also advised to correct any Sequence Rule issues in the Specification. Applicant is required to comply with the sequence rules by inserting the sequence identification numbers of all sequences recited within the claims and/or specification. See particularly 37 CFR 1.821(d).
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.
The claimed invention is directed to a naturally-occurring nucleic acid or fragment thereof, whether isolated or not, that is not patent-eligible pursuant to the Supreme Court decision in Association for Molecular Pathology v. Myriad Genetics, Inc., -- U.S. -- (June 13, 2013).
Claims 1, 11 and 12 are rejected under 35 U.S.C. 101 because the claimed invention is not directed to patent eligible subject matter. The instant rejection is issued because of recent "Guidance for Determining Subject Matter Eligibility Of Claims Reciting Or Involving Laws of Nature, Natural Phenomena, & Natural Products", currently accessible from <http://www.uspto.gov/patents/law/exam/myriad-mayo_guidance.pdf>.
In the instant case, when a claim is determined to recite or involve one or more judicial exceptions, the key inquiry becomes whether the claim as a whole recites something significantly different than the judicial exception. The Guidance provides weighing factors for determining whether a claim recites something that is significantly different than the judicial exception. If the totality of the relevant factors weighs toward eligibility, the claim qualifies as eligible subject matter. However, if the totality of the relevant factors weighs against eligibility, the claim should be rejected.
Based upon consideration of all of the relevant factors with respect to the claims as a whole, the factors weigh against something that is significantly different than a law or product of nature and therefore the claims do not qualify as eligible subject matter. The rationale for this determination is explained below:
Claim 1 is drawn to under Broadest Reasonable Interpretation (BRI) - A microbial biological control agent (MBCA), comprising a Streptomyces ardesiacus HL-06, wherein the Streptomyces ardesiacus HL-06 has been deposited on June 9, 2022 in the China General Microbiological Culture Collection Center (CGMCC) at NO.1 West Beichen Road, Chaoyang District, Beijing 100101, with a deposit number of CGMCC No.25033.
Given the broadest reasonable interpretation (BRI), the claimed “A microbial biological control agent (MBCA), comprising a Streptomyces ardesiacus HL-06, wherein the Streptomyces ardesiacus HL-06 has been deposited on June 9, 2022 in the China General Microbiological Culture Collection Center (CGMCC) at NO.1 West Beichen Road, Chaoyang District, Beijing 100101, with a deposit number of CGMCC No.25033” is to be a product/Law of nature. To be eligible, the claimed product is not markedly different in structure from a naturally occurring bacterial strain, In this case, the recited bacterial strain Streptomyces ardesiacus HL-06 is not markedly different from naturally occurring bacterial strain. See Association for Molecular Pathology v. Myriad
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Genetics Inc. 106 USPQ2d 1972 (U.S. Supreme Court 2013). As such, the claimed recited bacterial strain Streptomyces ardesiacus HL-06, is not markedly different in structure from naturally occurring bacterial strain, and thus, the claimed “bacterial strain Streptomyces ardesiacus HL-06 is not patent eligible subject matter.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because of the following analysis:
Step 1) Are the claims directed to a process, machine, manufacture or composition of matter?
Yes, the claims are drawn to a composition of matter or manufacture (a product).
Step 2a, Prong 1) Does the claim recite an Abstract Idea, Law of Nature or Natural Phenomenon?
Yes, the claim 1 is drawn to a Natural Phenomenon and Law of Nature, bacterial strain Streptomyces ardesiacus HL-06 would meet the defined claim and render it non-patent eligible.
Step 2a, Prong 2) Does the claim recite additional elements that integrate the Judicial Exception into a Practical Application?
The answer is No. the claimed bacterial strain Streptomyces ardesiacus HL-06 doesn’t improve any technology or technical field, apply or use the JE to effect to a particular application or apply/use the JE in some other meaningful way.
Step 2B) Does the claim recite additional elements that amount to significantly more than the Judicial Exception?
The answer is No, therefore, the recited bacterial strain Streptomyces ardesiacus HL-06 is not patent eligible.
Claims 11 and 12 are also not patent eligible for the same reason as discussed above for claim 1.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 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, 11 and 12 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 invention appears to employ novel microorganisms. Since the microorganisms are essential to the claimed invention, they must be obtainable by a repeatable method set forth in the specification or otherwise be readily available to the public. The recited microorganisms have not been shown to be publicly known and freely available. The enablement requirements of 35 U.S.C. 112 may be satisfied by a deposit of the microorganisms. The specification does not disclose a repeatable process to obtain the microorganisms and it is not apparent if the microorganisms are readily available to the public. Accordingly, it is deemed that a deposit of these plasmids should have been made in accordance with 37 CFR 1.801-1.809.
It is noted that applicants have deposited some of the organisms but there is no indication in the specification as to public availability. If the deposit was 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, stating that the specific strain has been deposited under the Budapest Treaty and that the strain will be available to the public under the conditions specified in 37 CFR 1.808, 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 CFR 1.801-1.809, applicants 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, showing that:
1. during the pendency of this application, access to the invention will be afforded to the Commissioner upon request;
2. upon granting of the patent the strain will be available to the public under the conditions specified in 37 CFR 1.808;
3. the deposit will be maintained in a public repository for a period of 30 years or 5 years after the last request or for the effective life of the patent, whichever is longer; and
4. the deposit will be replaced if it should ever become unavailable.
Conclusion
Status of the claims:
Claims 1, 11 and 12 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to IQBAL H CHOWDHURY whose telephone number is (571)272-8137. The examiner can normally be reached on M-F, at 9:00-5:00 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Manjunath N. Rao, can be reached on 571-272-0939. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Iqbal H. Chowdhury, Primary Patent Examiner
Art Unit 1656 (Recombinant Enzymes and Protein Crystallography)
US Patent and Trademark Office
Ph. (571)-272-8137 and Fax (571)-273-8137
/IQBAL H CHOWDHURY/
Primary Examiner, Art Unit 1656
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