DETAILED ACTION
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 .
Status of the Application
1. Claims 1-17 are pending and subject to examination on the merits. Claims 9-15 are withdrawn from consideration as being drawn to non-elected subject matter.
Election/Restrictions
2. Claims 9-15 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 06 October 2025.
Priority
3. 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.
Information Disclosure Statement
4. The information disclosure statement (IDS) submitted on 06 October 2025 has been considered by the examiner. See initialed and signed PTO/SB/08’s.
Drawings
5. The drawings are objected to because the “X-axis” in Fig. 6A should recite “Time (hours)” to conform with the other figures. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Compliance with Sequence Rules
6. The sequence listing, filed in computer readable form (CRF) and paper copy on , has been received and entered. This application contains sequence disclosures that are encompassed by the definitions for nucleotide and/or amino acid sequences set forth in 37 C.F.R. § 1.821(a)(1) and (a)(2). However, this application fails to fully comply with the requirements of 37 C.F.R. § 1.821 through 1.825; Applicants’ attention is directed to the final rulemaking notice published at 55 FR 18230 (May 1, 1990), and 1114 OG 29 (May 15, 1990).
The following parts of the Specification contain sequences that contain four or more specifically defined amino acids without any corresponding SEQ ID NO:
a) On page 15, Table 1, Paragraph 0068, there needs to be SEQ ID NO: associated with the listed sequence.
Applicants must amend the specification to identify the sequences appropriately by SEQ ID NO:. — See also MPEP 2422.
Claim Objections
7. Claims 2-3 are objected to because of the following informalities: “inserta” should be “incerta.” Appropriate correction is required.
8. Claim 8 is objected to because of the following informalities: “Desemzia sp.” should be italicized to ”Desemzia sp.”
Claim Rejections - 35 USC § 112(a)
9. 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.
10. Claim 8 is 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 claim 8 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 § 112(b)
11. 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.
12. Claims 1-8 and 16-17 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.
13. Claims 1-8 and 16-17 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 joint inventor regards as the invention. This is because the claims attempt to recite a process without setting forth any steps involved in the process. Specifically, claim 1 recites "using a microorganism of the genus Desemzia" and claim 4 recites "uses lactate oxidase" however, it is unclear what the process steps are supposed to be which results in the production of hydrogen peroxide (H2O2) utilizing a microorganism of the genus Desemzia and further a lactate oxidase. It is noted, the recitation of a "use" without any active, positive steps delimiting how the use is practiced is deemed indefinite. See MPEP 2173.05(q). Claims 2-3, 5-8, and 16-17 are included in the instant rejection, since they do not mitigate the issues.
14. Regarding claims 2-3 and 17, the phrase "represented by" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Specifically, it is unclear if “represented by” is merely an example or a definitive sequence. If “represented by” was amended to recite “consisting of” or “comprising,” depending on the desired openness or closedness of language, this would mitigate this issue. For examination purposes, “represented by” is interpreted that SEQ ID NO: 1 is merely an example of the 16S rDNA.
Claim Rejections - 35 USC § 101
15. 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.
16. Claims 1-8 and 16-17 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. whichproduces 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 is a naturally occurring process wherein said strain was isolated from contaminated soil in South Korea. As such, there is no distinguishable modification to delineate this naturally occurring process.
Claim Rejections - 35 USC § 102
17. 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.
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
18. Claims 1-8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ko et al (Ko et al., 2022, Microbiology Resource Announcements—cited herein) and as evidenced by AmphibiaWeb (AmphibiaWeb, 2021, Phylogeny, Taxonomy, and Nomenclature—downloaded 22 October 2025 from <https://amphibiaweb.org> as a PDF—cited herein) and Wei et al (Wei et al., 2025, downloaded 22 October 2025 from < https://view.officeapps.live.com/op/view.aspx?src=https%3A%2F%2Fdermatology.upenn.edu%2Fwp-content%2Fuploads%2Fsites%2F5%2F2021%2F02%2FSBDRC_abstract.docx&wdOrigin=BROWSELINK >). Regarding claims 1-8, drawn to a method of producing hydrogen peroxide using a non-pathogenic (claim 5) Desemzia sp. (claim 1), which is classified in the same clade (claim 6) but phylogenetically distinct branch (claim 7) from Desemzia incerta, specifically Desemzia sp strain C1 (claim 8), with a 16S rDNA sequence (claims 2-3), Ko et al. teach a Desemzia sp. strain C1 isolated from oil-contaminated soil in South Korea, producing hydrogen peroxide (abstract). Further, Ko et al. teaches that the Desemzia genus is limited because further novel species have not been reported since 1941 (paragraph 1). Regarding the phylogeny (claims 6-7) of the Desemzia sp., since the Desemzia sp strain C1 and Desemzia incerta share a phylogenetic genus, they share a phylogenetic clade. Additionally, since Desemzia sp. strain C1 is a distinct species to Desemzia incerta, they are found on distinct phylogenetic branches, as evidenced by AmphibiaWeb (p. 4, V. Taxonomy, paragraph 3, p. 5, fig. 5). Regarding the pathogenicity (claim 5), Wei et al. describes Desemzia sp. as a porcine skin commensal (line 9). Regarding claim 4, Ko et al. teaches the genome of Desemzia sp. strain C1 contains genes encoding various oxidases involved in H2O2 production, such as lactate oxidase (LOX) (p. 1, last 2 lines).
It is noted that the authors and inventors listed on this work and the current invention are nearly identical. However, one author differs from the inventors: the inventor listed is Hor Gil Her, while the author listed is Hor Gil Hur. It is unclear if this a typographical error or two different people.
Claim Rejections - 35 USC § 103
18. 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.
19. Claim 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Ko et al (Ko et al., 2022, Microbiology Resource Announcements—cited herein) as evidenced by AmphibiaWeb (AmphibiaWeb, 2021, Phylogeny, Taxonomy, and Nomenclature—downloaded 22 October 2025 from <https://amphibiaweb.org> as a PDF—cited herein) and Wei et al (Wei et al., 2025, downloaded 22 October 2025 from < https://view.officeapps.live.com/op/view.aspx?src=https%3A%2F%2Fdermatology.upenn.edu%2Fwp-content%2Fuploads%2Fsites%2F5%2F2021%2F02%2FSBDRC_abstract.docx&wdOrigin=BROWSELINK > as a PDF) as applied to claims 1 and 4-8 above, and further in view of Morikawa et al (Morikawa et al., 2017, JP2017148804A—cited on the IDS filed 06 October 2025).
The teachings of Ko et al. as evidenced by AmphibiaWeb and Wei et al. are discussed above and incorporated into the instant rejection.
Ko et al. as evidenced by AmphibiaWeb and Wei et al. do not teach the utilization of hydrogen peroxide derived from Desemzia sp. strain C1 to degrade a pollutant. Morikawa et al. teaches bactericidal action of the Fenton reaction, which generates hydroxyl radicals from hydrogen peroxide by the action of divalent iron, where the reaction catalyst can be injected into contaminated soil for sterilization and/or decomposition of harmful substances and hardly decomposable pollutants (p. 2, paragraph 3). Further, Morikawa et al. teaches that the sterilization agent comprising the Fenton reaction can be microorganism derived hydrogen peroxide (p. 6, paragraph 8).
Therefore, it 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 combine the teachings of Ko et al. as evidenced by AmphibiaWeb and Wei et al. and Morikawa et al. to utilize the hydrogen peroxide produced from a Desemzia sp. to degrade a pollutant utilizing a Fenton reaction catalyst in the fields of agriculture and food processing to remove harmful substances, as taught by Morikawa et al. One would be motivated to combine these teachings to arrive at the instant claims to develop and utilize a sterilization method which has no residual effect harmful to the human body and is inexpensive in many industrial fields (p. 1, paragraph 2). There would be reasonable expectation of success, yielding no surprising results when combining the teachings of Ko et al. as evidenced by AmphibiaWeb and Wei et al., since Ko et al. teaches the utilization of microbial derived hydrogen peroxide in the degradation of a pollutant.
Conclusion
19. All claims are rejected.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/CIARA A MCKNIGHT/Examiner, Art Unit 1656
/SUZANNE M NOAKES/Primary Examiner, Art Unit 1656