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 .
Applicants’ Amendment
1) Acknowledgment is made of Applicants’ amendment filed 02/04/26 in response to the non-final Office Action mailed 11/05/25.
Status of Claims
2) Claims 1-3 and 6 have been canceled via the amendment filed 02/04/26.
New claims 15 and 16 have been added via the amendment filed 02/04/26.
Claims 4, 5 and 7-16 are pending.
Claims 4, 5, 15 and 16 are under examination.
The Myung Hee Kim Declaration
3) Acknowledgment is made of the declaration by Myung Hee Kim filed 02/04/26 under37 C.F.R 1.130(a). The declarant states that Kibaek Lee is an author of the applied reference of Noori et al. (Bioresource Technology 352: 127077, pages 1-8, Available online 01 April 2022, of record), but is not listed as an inventor because Kibaek Lee did not contribute to the conception of the claimed invention. The declarant further states that Byungkook Hwang is not an author of the reference, but contributed to the application and system using the bacteria disclosed and claimed in the present application.
Biological Material Deposit-related Statements
4) Acknowledgment is made of the statements of the attorney of record filed 02/04/2026 regarding the deposit of the biological material, i.e., the Bacillus sp. SDC-U1 strain deposited with the accession number KCTC 14857BP.
Priority Application
5) Acknowledgment is made of Applicants’ filing on 02/04/26 of a copy of the certified English translation of the Korean priority application 10-2022-0071579 filed 06/13/2022.
Prior Citation of Title 35 Sections
6) The text of those sections of Title 35 U.S. Code not included in this action can be found in a prior Office Action.
Prior Citation of References
7) The references cited or used as prior art in support of one or more rejections in the instant Office Action and not included on an attached form PTO-892 or form PTO-1449 have been previously cited and made of record.
Priority Application
8) Acknowledgment is made of Applicants’ filing on 02/04/26 of a copy of the certified English translation of the Korean priority application 10-2022-0071579 filed 06/13/2022.
Objection(s) Moot
9) The objections to claims 1 and 3 set forth at paragraphs 16(a) and 16(b) of the Office Action mailed 11/05/2025 are moot in light of Applicants’ cancellation of the claims.
Rejection(s) Moot
10) The rejection of claims 1-3 and 6 set forth at paragraph 9 of the Office Action mailed 11/05/2025 under 35 U.S.C § 101 as being directed to a judicial exception without significantly more is moot in light of Applicants’ cancellation of the claims.
11) The rejection of claims 1-3 and 6 set forth at paragraph 11 of the Office Action mailed 11/05/2025 under 35 U.S.C § 112(a) or 35 U.S.C § 112 (pre-AIA ), first paragraph, with regard to the biological material deposit issue is moot in light of Applicants’ cancellation of the claims.
12) The rejection of claim 3 set forth at paragraph 13 of the Office Action mailed 11/05/2025 under 35 U.S.C § 112(b) or 35 U.S.C § 112 (pre-AIA ), second paragraph, as being indefinite is moot in light of Applicants’ cancellation of the claim.
13) The rejection of claims 1-3 and 6 set forth at paragraph 15 of the Office Action mailed 11/05/2025 under 35 U.S.C § 102(a) as being anticipated by Noori et al. (Bioresource Technology 352: 127077, pages 1-8, Available online 01 April 2022, of record) is moot in light of Applicants’ cancellation of the claims.
Rejection(s) Withdrawn
14) The rejection of claims 4 and 5 set forth at paragraph 9 of the Office Action mailed 11/05/2025 under 35 U.S.C § 101 as being directed to a judicial exception without significantly more is withdrawn in light of Applicants’ claim amendments. A new rejection is set forth below in this Office Action to address the claims as amended.
Applicants state that claim 4 is amended to incorporate the limitations of claim 6, such that the composition of claim 4 now recites specific carriers and the new claims 15 and 16 further describe said carriers. Applicants submit that the isolated Bacillus SDC-U1 strain and carrier composition is patentable subject matter under 35 U.S.C § 101.
Applicants’ arguments have been considered. Applicants are referred to the rejection set forth below in this Office Action to address the claims as amended.
15) The rejection of claims 4 and 5 set forth at paragraph 11 of the Office Action mailed 11/05/2025 under 35 U.S.C § 112(a) or 35 U.S.C § 112 (pre-AIA ), first paragraph, with regard to the biological material deposit issue is withdrawn in light of Applicants’ compliance with the biological material deposit Rules. Applicants have submitted a copy of the Notice from the depository that identifies the biological material, i.e., the Bacillus sp. SDC-U1 strain deposited with the accession number KCTC 14857BP.
16) The rejection of claims 4 and 5 set forth at paragraph 15 of the Office Action mailed 11/05/2025 under 35 U.S.C § 102(a) as being anticipated by Noori et al. (Bioresource Technology 352: 127077, pages 1-8, Available online 01 April 2022, of record) is withdrawn in light of the 02/04/26 Myung Hee Kim acknowledged supra.
Double Patenting Rejection(s)
17) The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the claims at issue are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/patent/patents-forms/. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
18) Claims 4, 5 and 15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 3 and 4 of the co-pending application 18395897. Although the conflicting claims are not identical, they are not patentably distinct from each other because said claims of the co-pending ‘897 application claiming a quorum quenching media composition comprising a carrier as recited in claim 3 therein and as recited in claim 4 therein and quorum quenching microbes on the carrier read on instant claims. As in In re Basell Pollolefine Italia S.P.A., 89 USPQ2d 1030, 1036 (Fed. Cir. 2008), the specification of the co-pending ‘897 application, for example at sections [63] and [64], identifies the Bacillus sp. SDC-U1 as a quorum quenching microbe of the invention thus indicating that the Bacillus sp. SDC-U1
is intended to fall within the coverage and/or meaning of the claims. Note that ‘[The specification] may be used to learn the meaning of terms and in interpreting the coverage of a claim’ [Emphasis added]. In re Basell Pollolefine Italia S.P.A., 89 USPQ2d 1030, 1036 (Fed. Cir. 2008).
Rejection(s) under 35 U.S.C § 101
19) 35 U.S.C § 101 states:
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.
20) Claims 4, 5, 15 and 16 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.
Claims 4 and 5 are directed to a composition comprising Bacillus sp. SDC-U1 strain deposited with the accession number KCTC 14857BP or cultures thereof and a carrier such as an organic material, an inorganic material, or an organic-inorganic composite. The organic carrier per new claim 15 is a polymer and the inorganic material per claim 16 is silica or metal.
Because the claimed Bacillus sp. SDC-U1 strain and the carrier are composed of matter, at least one embodiment encompassed within the broadest reasonable interpretation (BRI) of the instant claim is directed to a statutory category, i.e., a composition of matter (Step 1: YES). The Bacillus sp. SDC-U1 strain is a naturally occurring strain. For example, Kim et al. J. Membrane Science 690: 122198, pages 1-8, 23 October 2023 (of record) teach that Bacillus sp. SDC-U1, a QQ bacterium, was isolated from a display industry wastewater sludge. See first sentence under section 2.1. There is no evidence that the claimed Bacillus sp. SDC-U1 strain is markedly different from what exists in nature. MPEP 2106.04(c)(II)(C) (“Thus, in order to be markedly different, applicant must have caused the claimed product to possess at least one characteristic that is different from that of the [closest naturally occurring] counterpart.”). Supreme Court has made it clear in Myriad that eligibility requires the creation of something not naturally occurring, which is markedly different from what exists in nature. Unlike the Chakrabarty bacterium, which was new “with markedly different characteristics from any found in nature” 447 U.S., at 310, 100 S. Ct. 2204, 65 L. Ed. 2d 144, due to the multiple additional plasmids and resultant “capacity for degrading oil”, there is no indication that the instantly claimed strain is genetically manipulated or structurally modified in any marked or significant way such that the structural difference results in change of properties of the strain. Note that in Chakrabarty and Myriad, the marked difference inquiry was focused on the structural characteristics of the product, not how it was used or how it was made. Furthermore, that silica is naturally deposited on Bacillus species is recognized in the art. For example, see at least Abstract/Summary and page 254 of Ikeda et al. J. Biosci. Bioengineer. 137: 254-259, 2024. The art recognizes that Bacillus species are ubiquitous in nature, biosilicification of which species forms a significant amount of silica. See 1st full sentence on page 1329 of Ikeda et al. Biosci. Biotechnol. Biochem. 85: 1324-1331, 2021. Silica is incorporated by organisms during the process of natural biosilicification. Biosilicification is the process by which organisms incorporate soluble, monomeric silicic acid, Si(OH)4, in the form of polymerized insoluble silica, SiO2. See abstract of Ikeda et al. J. Biosci. Bioengineer. 137: 254-259, 2024. It is further known in the art that long-chain organic polyamine compounds are embedded in Bacillus biosilica. See Abstract/Summary and 2nd full paragraph in right column of page 254 of Ikeda et al. J. Biosci. Bioengineer. 137: 254-259, 2024. Thus, the Bacillus sp. SDC-US strain and the carrier as recited are naturally occurring elements. In Funk Brothers, the Court held that the composition was not patent eligible because the patent holder did not alter the bacteria in any way. In the instant case, the Bacillus sp. SDC-U1 strain and the carrier are ‘product of nature’ exceptions, and the claims are directed to judicial exceptions (Step 2A Prong One: YES). Judicial exceptions include all natural products including those derived from natural sources or patients such as naturally occurring microorganisms, proteins, peptides, glycoproteins, glycopeptides, carbohydrates, and other substances found in or derived therefrom, or from nature. Next, the claims as a whole are analyzed to determine whether any additional element, or combination of elements, is sufficient to ensure that the claims amount to significantly more than the exceptions. There is nothing that provides significantly more or that integrates the claimed naturally occurring strain and the carrier, i.e., the judicial exceptions, into a practical application (Step 2A Prong Two: NO). The claims as a whole do not amount to significantly more than a ‘product of nature’ (Step 2B: NO). Therefore, the claims are not directed to a patent eligible subject matter.
The rationale for this determination is formed in view of the 2019 PEG, the 2015 Update of the 2014 Interim Guidance on Patent Subject Matter Eligibility (79 FR 4618) (hereafter Interim Eligibility Guidance) dated 16 December 2014, the Life Sciences Examples issued in May 2016, and in view of Myriad v Ambry, CAFC 2014-1361, -1366, 17 December 2014. The unpatentability of laws of nature was confirmed by the U.S. Supreme Court in Mayo Collaborative Services v. Prometheus Laboratories, Inc., No. 10-1150 (March 20, 2012). The unpatentability of natural products was confirmed by the U.S. Supreme Court in Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U. S. (June13, 2013).
Conclusion
21) No claims are allowed.
22) Applicants’ amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 C.F.R 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 extension fee pursuant to 37 C.F.R 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.
Correspondence
23) Any inquiry concerning this communication or earlier communications from the Examiner should be directed to S. Devi, Ph.D., whose telephone number is (571) 272-0854. A message may be left on the Examiner’s voice mail system. The Examiner is on a flexible work schedule, however she can normally be reached Monday to Friday from 8.00 a.m. to 4.00 p.m. (EST). If attempts to reach the Examiner by telephone are unsuccessful, the Supervisor of AU 1645, Daniel E. Kolker, can be reached at (571) 272-3181. The fax phone number for the organization where this application or proceeding is assigned (571) 273-8300.
24) Information regarding the status of an application may be obtained from Patent Center. Status information for unpublished applications is available through Patent Center or Private PAIR to authorized users only. Should you have questions about access to Patent Center or the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). 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.
/S. DEVI/
S. Devi, Ph.D.Primary Examiner
Art Unit 1645
February, 2026