DETAILED ACTION
Status of the Application
1. Claims 1-3, 5-7, and 16-29 are pending and subject to examination on the merits. Claims 1-3, 5-7, and 16-29 are currently under examination.
Priority
2. Acknowledgement is made of applicant’s claim for foreign priority based on an application filed in KR (KR10-2022-0062765 on 23 May 2022. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Withdrawn Objections/Rejections
3. The objection to the drawings over Fig. 6A is withdrawn, since the amended figure now recites “Time (hours)” conforming with the other figures.
4. The objection to the specification for the recitation of a sequence without the proper sequence identifier at p. 15, Table 1 is withdrawn, since the specification was amended to include that the sequence is SEQ ID NO: 1.
5. The objection to claims 6-7 (invertedly recited as claims 2-3 in the previous office action) for reciting “inserta” has been withdrawn, since the claims were amended to recite “incerta.”
6. The 35 U.S.C. 112(b) indefiniteness rejection to claims 1-8 and 16-17 for reciting “using a microorganism of the genus Desemzia” and “uses lactate oxidase.”
7. The 35 U.S.C. 112(b) indefiniteness rejection to claims 2-3 and 17 for reciting “represented by” is withdrawn, since the claim was amended to recite “comprising.”
8. The 35 U.S.C. 102 anticipation rejection over Ko et al. and as evidenced by AmphibiaWeb and Wei et al. is withdrawn, since the Applicant provided a declaration confirming that “Hor Gil Hur” of the listed Applicants and “Hor Gil Her” of the Ko et al. art is the same person. Additionally, as explained in the declaration, the co-author, Seunghyon Kim, acted under Professor Hor Gil Her’s direction and supervision and did not contribute to the invention, and therefore, is not named as a co-inventor.
9. The 35 U.S.C. 103 obviousness rejection over Ko et al. and as evidenced by AmphibiaWeb and Wei et al. and further in view of Morikawa et al. is withdrawn, since the Applicant provided a declaration confirming that “Hor Gil Hur” of the listed Applicants and “Hor Gil Her” of the Ko et al. art is the same person.
Modified Rejections—necessitated by amendments
Claim Rejections - 35 USC § 112(a)
10. 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.
11. Claims 1-3, 5-7, and 16-29 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 specification fails to provide an enabling disclosure, because the specification does not provide evidence that the claimed biological materials (Desemzia sp. strain C1 (accession number KCTC1520BP)) is : (1) known and readily available to the public; (2) reproducible from the written description; or, (3) deposited in compliance with the criteria set forth in 37 CFR 1.801-1.809 under the Budapest Treaty.
The specification lacks complete deposit information for the strain identified as Desemzia sp. strain C1 (accession number KCTC1520BP). Because it is not clear that the Desemzia sp. strain C1 (accession number KCTC1520BP) designated as Desemzia sp. strain C1 (accession number KCTC1520BP) are known and publicly available or can be reproducibly isolated without undue experimentation, and because the invention of the claims or uses the strain, a suitable deposit for patent purposes is required. Accordingly, filing of evidence of the reproducible production of the bacterial strain is necessary to practice the instant invention or filing of evidence of deposit is required. Without a publicly available deposit of the above bacterial strain, one of ordinary skill in the art could not be assured of the ability to practice the invention as claimed. Exact replication of the bacterial strain is an unpredictable event. Applicants must comply with the criteria set forth in 37 CFR 1.801-1.809.
If the deposits have not been made under the Budapest Treaty, then in order to certify that the deposits meet the criteria set forth in 37 CFR 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.
For each deposit made pursuant to these regulations, the specification shall contain:
The accession number for the deposit;
The date of the deposit;
A description of the deposited biological material sufficient to specifically identify it and to permit examination; and
The name and address of the depository.
A viability statement for each deposit of a biological material not made under the Budapest Treaty on the International Recognition of the deposit of Microorganisms for the Purposes of Patent Procedure must be filed in the application and must contain:
The name and address of the depository;
The name and address of the depositor;
The date of deposit;
The identity of the deposit and the accession number given by the depository;
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.
Applicant must assure that:
Access to the deposit will be available during pendency of the patent application making reference to the deposit.
All restrictions imposed by the depositor on the availability to the public of the deposited material will be irrevocably removed upon the granting of the patent.
As a possible means for completing the record, applicant may also submit a copy of the contract with the depository for deposit and maintenance of each deposit along with the necessary statements in order to meet the criteria set forth in 37 CFR 1.801-1.809.
Applicant’s attention is directed to In re Lundak, 773 F.2nd. 1216, 227 USPQ 90 (CAFC 1985) and 37 CRF 1.801-1.809 for further information concerning deposit practice.
Claim Rejections - 35 USC § 101
12. 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.
13. Claims 1-3, 5-7, and 16-29 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a natural phenomenon) without additional elements that integrate the judicial exception into a practical application. An analysis with respect to the claims as a whole reveals that they do not include additional elements that integrate the judicial exception into a practical application. See MPEP 2106.
Analysis of subject-matter eligibility under 35 U.S.C. § 101 requires consideration of the following steps:
Step (1) whether the claim is directed to one of the four categories recited in §101 (process, machine, manufacture or composition of matter);
Step (Revised 2A - Prong 1) do the claims recite an abstract idea (mathematical concepts, mental processes or method of organizing human activity), law of nature or natural phenomenon;
Step (Revised 2A - Prong 2) do the claims recite additional elements that integrate the judicial exception into a practical application; and
Step (2B) whether the claim as a whole recites something that amounts to significantly more than the judicial exception. (See 2019 Revised Patent Subject Matter Eligibility Guidance (2019 PEG)).
Step 1: Yes; the claims are directed to a method or process.
Step 2A – Prong 1: Yes, the claims recite a natural phenomenon, namely, a naturally occurring process in a bacterial strain, Desemzia sp. strain C1 (accession number KCTC15203BP), which produces hydrogen peroxide.
Step 2A – Prong 2: No, the claims do not recite any additional elements that integrate the judicial exception into a practical application because the claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because there are no additional elements claimed with the Desemzia sp. producing hydrogen peroxide. According, to “Example 1: Isolation and culture of Desemzia sp. strain C1: Soil exposed to waste oil for a long time was collected from an auto repair shop in Buk-gu, Gwangju, South Korea. Next, Desemzia sp. strain C1 (accession number: KCTCl5203BP) was isolated based on the Prussian blue-zone formed by the reaction of ferric cyanide and hydrogen peroxide (H202) in Prussian blue agar medium. It was confirmed that Desemzia sp. strain C1 formed a large Prussian blue-zone by producing a large amount of hydrogen peroxide (H202) (FIG. 1).” (paragraphs 0064-0065). Therefore, this is a naturally occurring phenomenon, where the isolated strain produces hydrogen peroxide.
Step 2B: As noted in answering that of 2A – This judicial exception is not integrated into a practical application because Desemzia sp. producing hydrogen peroxide in the presence of lactate and/or pollutants and obtaining a subsequent concentration reading at an optical density of 600nm is a naturally occurring process (and measurement thereof), wherein said strain was isolated from contaminated soil in South Korea. As such, there is no distinguishable modification to delineate this naturally occurring process.
Applicant’s Arguments and Examiner’s Rebuttal:
The Applicant traverses the 35 U.S.C. 112(a) rejection because they argue that the accession number KCTC1520BP being added to the claim limitation fulfills the enablement requirement. Additionally, the applicant traverses the 35 U.S.C. 101 rejection that the subject matter is ineligible as being directed to a naturally occurring process because the claim now recites the presence of lactate during the culturing step.
Regarding the applicant’s argument that the inclusion of the accession number into claim 1 satisfies the enablement rejection, the examiner respectfully disagrees. The enablement rejection requires in addition to the accession number a declaration, affidavit, and/or statement demonstrating that the strain is: (1) known and readily available to the public; (2) reproducible from the written description; or, (3) deposited in compliance with the criteria set forth in 37 CFR 1.801-1.809 under the Budapest Treaty. In addition, it is unclear if the deposit was made under the Budapest Treaty because the information on the Receipt in the Case of an Original Deposit (filed in this application on 02/07/2023), part IV (Receipt of Request for Conversion), regarding the conversion to a deposit under the Budapest Treaty is incomplete because no date has been stipulated that such a request was ever made. Please review the rejection above and provide the written statement, declaration, and/or affidavit to comply fully with the enablement requirement.
Regarding the applicant’s argument that the culturing of the Desemzia sp. in the presence of lactate is a human controlled process, the examiner respectfully disagrees because lactate is readily found in soil as a product of fermentation by lactic acid bacteria found in natural environments, such as soil, plant surfaces, and decomposing organic matter, as evidenced by FulCrop Sciences (FulCrop Sciences, 2026, “Lactic Acid, Enhancing Microbial Activity, Plant Vitality, and Soil Health,” downloaded on 30 June 2026 as a PDF from <https://fulcropsciences.com/revitalize-the-soil-lactic-acid-in-enhancing-microbial-activity-plant-vitality-and-soil-health/> --provided herein), where the Desemzia sp. was originally isolated from soil.
The examiner does not find the arguments presented by the applicant persuasive, and for these reasons, the rejections of record above apply.
Conclusion
14. THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
15. Any inquiry concerning this communication or earlier communications from the examiner should be directed to CIARA A MCKNIGHT whose telephone number is (703)756-4791. The examiner can normally be reached M-F 8:00am-4:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Manjunath 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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/CIARA A MCKNIGHT/Examiner, Art Unit 1656
/SUZANNE M NOAKES/Primary Examiner, Art Unit 1656
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