Prosecution Insights
Last updated: July 17, 2026
Application No. 18/167,689

PROBIOTIC STRAIN FOR COUNTERING CARIES PATHOGENS

Non-Final OA §101§102§103§112
Filed
Feb 10, 2023
Priority
Feb 10, 2022 — provisional 63/308,833
Examiner
PAK, YONG D
Art Unit
1652
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
The Governing Council of the University of Toronto
OA Round
2 (Non-Final)
75%
Grant Probability
Favorable
2-3
OA Rounds
0m
Est. Remaining
89%
With Interview

Examiner Intelligence

Grants 75% — above average
75%
Career Allowance Rate
704 granted / 944 resolved
+14.6% vs TC avg
Moderate +14% lift
Without
With
+14.1%
Interview Lift
resolved cases with interview
Typical timeline
2y 10m
Avg Prosecution
51 currently pending
Career history
990
Total Applications
across all art units

Statute-Specific Performance

§101
3.4%
-36.6% vs TC avg
§103
33.7%
-6.3% vs TC avg
§102
15.1%
-24.9% vs TC avg
§112
9.6%
-30.4% vs TC avg
Black line = Tech Center average estimate • Based on career data from 944 resolved cases

Office Action

§101 §102 §103 §112
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 The amendment filed on September 19, 2025 has been entered. Election/Restrictions Applicant elected with traverse of Group I in the reply filed on January 9, 2025. Claims 15-26 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on January 9, 2025. Status of the Claims Claims 1-2, 6-9, 12, 15-26, and 33 are pending. Claims 15-26 are withdrawn. Claims 1-2, 6-9, 12, and 33 are under examination. Information Disclosure Statement The information disclosure statement (IDS) submitted on May 1, 2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner. Response to Amendments/Arguments Objection to Specification Applicant’s arguments, see page 8 of the Remarks, filed September 19, 2025, with respect to the specification have been fully considered and are persuasive. The specification has been amended to delete the embedded hyperlink and/or other form of browser-executable code and corrected the spelling of “Methyllanthionine”. Therefore, the objections of the specification have been withdrawn. Claim Objections Applicant’s arguments, see page 9 of the Remarks, filed September 19, 2025, with respect to claim 2 have been fully considered and are persuasive. Claim 2 has been amended to recite “endogenous manL”. Therefore, the objection of claim 2 has been withdrawn. Applicant’s arguments, see page 9 of the Remarks, filed September 19, 2025, with respect to claim 5 have been fully considered and are persuasive. Claim 5 has been cancelled. Therefore, the objections of claim 5 have been withdrawn. Applicant’s arguments, see page 9 of the Remarks, filed September 19, 2025, with respect to claim 12 have been fully considered and are persuasive. Claim 12 has been amended to delete the objected phrases. Therefore, the objection of claim 12 has been withdrawn. 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. 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. Withdrawn Rejections Applicant’s arguments, see page 16 of the Remarks, filed September 19, 2025, with respect to claim 2 have been fully considered and are persuasive. Claim 2 has been amended to recite the reference S. salivarius. Claim 2 has also been amended to recite “deoxyglucose and/or metabolites thereof” to clarify compounds having resistance to the claimed strain. Therefore, the rejections of claim 2 under 35 U.S.C. 112(b) have been withdrawn. Applicant’s arguments, see page 16 of the Remarks, filed September 19, 2025, with respect to claim 6 have been fully considered and are persuasive. Claim 6 has been amended to correct its antecedent basis. Therefore, the rejection of claim 6 under 35 U.S.C. 112(b) has been withdrawn. Applicant’s arguments, see page 16 of the Remarks, filed September 19, 2025, with respect to claims 6-7 have been fully considered and are persuasive. Claims 6-7 have been amended to depend from claim 1, which recites that Pep1-4 have the amino acid sequence of SEQ ID NO:5-8, respectively. Therefore, the rejection of claims 6-7 under 35 U.S.C. 112(b) has been withdrawn. Applicant’s arguments, see page 17 of the Remarks, filed September 19, 2025, with respect to claim 8 have been fully considered and are persuasive. Claim 8 has been amended to correct is antecedent basis and to recite “. Applicant’s arguments that the enzymes of the a “lantibotic synthesis protein” are definite has been found persuasive. Therefore, the rejection of claim 8 under 35 U.S.C. 112(b) has been withdrawn. Applicant’s arguments, see pages 17-18 of the Remarks, filed September 19, 2025, with respect to claim 9 have been fully considered and are persuasive. Claim 9 has been amended to clarify the inhibitory activity of the strain. Claim 9 has also been amended to delete the phrase “for example”. Therefore, the rejections of claim 9 under 35 U.S.C. 112(b) have been withdrawn. Applicant’s arguments, see page 18 of the Remarks, filed September 19, 2025, with respect to claim 12 have been fully considered and are persuasive. Claim 12 has been amended to delete the indefinite limitations. Therebefore, the rejection of claim 12 under 35 U.S.C. 112(b) has been withdrawn. Maintained Rejection Claim 8 is 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. Claim 8 recites the limitation “plasmid further expresses..”. The metes and bounds of this phrase in the context of the above claims are not clear. It is unclear how a plasmid express protein. Clarification is requested. Applicant's arguments filed September 19, 2025 have been fully considered but they are not persuasive. Applicant argues that claim 8 has been amended to replace “expresses” with “encodes”. However, claim 8 has not been amended to replace “expresses” with “encodes”. Therefore, the rejection has been maintained. New Rejections Claim 2 is 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 pre-AIA the applicant regards as the invention. Claim 2 recites the limitation “strain comprising LAB813 as show in GenBank ID NO: CP040803, BLIS M18® or BLIS K12®”. The metes and bounds of this limitation in the context of the above claims are not clear. LAB813 are plasmids. The limitations are not reference by any specific SEQ ID NO: and therefore are not fully defined. The polynucleotide sequence identified by an Accession Number or other database/products can be altered, whereas a nucleic acid sequence identified by a SEQ ID NO presented in a Sequence Listing is fixed and definite. Clarification is requested. Claim 2 is 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 pre-AIA the applicant regards as the invention. Claim 2 contains the trademark/trade name BLIS M18® or BLIS K12®”. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe plasmids and, accordingly, the identification/description is indefinite. 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. 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. Withdrawn Rejections Applicant' s arguments, see pages 10-15 of the Remarks, filed September 19, 2025, with respect to claims 1-2, 5-9, and 12 have been fully considered and are persuasive. Claim 1 has been amended to narrow the genus to S. salivarius expressing Pep1-Pep-4 having the amino acid sequence of SEQ ID NO:5-8, respectively. Applicant' s argument that the specification provides numerous examples to support the claimed genus has been found persuasive. Therefore, the rejection of claims 1-2, 5-9, and 12 h under 35 U.S.C. 112(a) for lack of written description has been withdrawn. Applicant' s arguments, see pages 10-15 of the Remarks, filed June 26, 2025, with respect to claims 1-2, 5-9, and 12 have been fully considered and are persuasive. Claim 1 has been amended to narrow the scope to S. salivarius expressing Pep1-Pep-4 having the amino acid sequence of SEQ ID NO:5-8, respectively. Therefore, the rejection of claims 1-2, 5-9, and 12 under 35 U.S.C. 112(a) for lack enablement has been withdrawn. New Rejection Claim 9 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 written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 9 are drawn to S. salivarius having inhibitory or bactericidal activity against carcinogenic bacterial growth”. However, the function of having inhibitory or bactericidal activity against carcinogenic bacterial growth was not described in the application as originally filed nor in any of its parent applications. Therefore, claim 9 contain new matter. Applicant in the Remarks filed on September 29, 2025 indicate that support for newly amended claim 9 can be found in the specification at paragraphs [0070]-[0073]. However, upon perusal of the specification at the above paragraphs, support for the amendment was not found. Given this lack of description of the newly introduced function, the specification fails to sufficiently describe the claimed invention in such full, clear, concise, and exact terms that a skilled artisan would recognize that applicants were in possession of the inventions of claim 9 at the time of filing of the instant application. Claim Rejections - 35 USC § 102 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. The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action: A person shall be entitled to a patent unless – (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. (a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention. Withdrawn Rejections Applicant’s arguments, see page 19 of the Remarks, filed September 19, 2025, with respect to claims 1, 6-7, 9, and 12 have been fully considered and are persuasive. Claim 1 has been amended to incorporate the subject matter of claim 5, which is not taught by Chilcott (WO 03/070919 – cited previously on form PTO-892). Therefore, the rejection of claims 1, 6-7, 9, and 12 under 102(a)(1) and 102(a)(2) as being anticipated by Chilcott has been withdrawn. Applicant’s arguments, see pages 19-20 of the Remarks, filed September 19, 2025, with respect to claims 1-2, 6-7, 9, and 12 have been fully considered and are persuasive. Claim 1 has been amended to incorporate the subject matter of claim 5, which is not taught by Pelletier et al. (Biochemistry 37:1604-1612, Published: 1998 – cited previously on form PTO-892). Therefore, the rejection of claims 1-2, 6-7, 9, and 12 under 102(a)(1) as being anticipated by Chilcott has been withdrawn. Claim(s) 1, 6-7, 9, 12, and 33 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gong (Complete Genome Sequence of Megaplasmid-Bearing Streptococcus salivarius Strain LAB813, Isolated from the Dental Plaque of a Caries-Free Child. Microbiol. Resour. Announc. 2019, 8, e01092-19 – form PTO-892) and evidenced by CP040803 (GenBank Database. September 6, 2019 – form PTO-892) and Goldberg (Inhibitory Effects of Streptococcus salivarius LAB813 on Cariogenic Microbial Biofilms. Master of Science Orthodontics. Faculty of Dentistry University of Toronto. Pages 1-93. 2021. – form PTO-892). Regarding claims 1 and 9, Gong discloses an isolated Streptococcus salivarius strain comprising the megaplasmid LAB813, wherein the nucleic acid sequence is disclosed in CP040803 (abstract, pages 1-2). The Streptococcus salivarius strain expresses four lantibiotic salivaricn M peptides having 100% sequence identity to Pep1-Pep4 of SEQ ID NO:5-8, respectively, of the instant application, as evidenced by CP040803 (pages 1-3 and see the sequence alignments below). Regarding the property of having antimicrobial activity against Streptococcus mutans, the Streptococcus salivarius strain comprising the megaplasmid LAB813 has antimicrobial activity against Streptococcus mutans, as evidenced by Goldberg (see Abstract). Regarding claim 6, the Streptococcus salivarius LAB813 strain express the four peptides as a multipeptide protein. Regarding claim 7, the Streptococcus salivarius LAB813 strain is comprised of 184,700 base pairs as evidenced by CP040803 (page 1). Regarding claim 12, since the Streptococcus salivarius strain comprising the megaplasmid LAB813 has antimicrobial activity against Streptococcus mutans, a major cariogenic bacterial species, the Streptococcus salivaris strain comprising the megaplasmid LAB813 has caries prevention activity. Regarding claim 33, MPEP 2111.02.II. states that “statements in the preamble reciting the purpose or intended use of the claimed invention must be evaluated to determine whether or not the recited purpose or intended use results in a structural difference (or, in the case of process claims, manipulative difference) between the claimed invention and the prior art. If so, the recitation serves to limit the claim..”. In the instant case, the recited intended use “for preventing or treating streptococcal throat infections and/or periodontal diseases” do not result in a structural different between the claimed strain and the strain of the prior art. Therefore, the recitation does not limit claim 33. Therefore, the reference of Gong anticipates claims 1, 6-7, 9, 12, and 33. Claim Rejections - 35 USC § 103 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. The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows: 1. Determining the scope and contents of the prior art. 2. Ascertaining the differences between the prior art and the claims at issue. 3. Resolving the level of ordinary skill in the pertinent art. 4. Considering objective evidence present in the application indicating obviousness or nonobviousness. This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention. Claim(s) 1-2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gong (Complete Genome Sequence of Megaplasmid-Bearing Streptococcus salivarius Strain LAB813, Isolated from the Dental Plaque of a Caries-Free Child. Microbiol. Resour. Announc. 2019, 8, e01092-19 – form PTO-892), Pelletier (The phosphoenolpyruvate:mannose phosphotransferase system of Streptococcus salivarius. Functional and biochemical characterization of IIABL(Man) and IIABH(Man). Biochemistry. 1998 Feb 10;37(6):1604-12 - cited previously on form PTO-892), and Gauthier (Positive selection for resistance to 2-deoxyglucose gives rise, in Streptococcus salivarius, to seven classes of pleiotropic mutants, including ptsH and ptsI missense mutants. Mol Microbiol. 1994 Sep;13(6):1101-9 - form PTO-892) and evidenced by CP040803 (GenBank Database. September 6, 2019 – form PTO-892) and Goldberg (Inhibitory Effects of Streptococcus salivarius LAB813 on Cariogenic Microbial Biofilms. Master of Science Orthodontics. Faculty of Dentistry University of Toronto. Pages 1-93. 2021. – form PTO-892). Regarding claim 1, Gong discloses an isolated Streptococcus salivarius strain comprising the megaplasmid LAB813, wherein the nucleic acid sequence is disclosed in CP040803 (abstract, pages 1-2). The Streptococcus salivarius strain expresses four lantibiotic salivaricn M peptides having 100% sequence identity to Pep1-Pep4 of SEQ ID NO:5-8, respectively, of the instant application, as evidenced by CP040803 (pages 1-3 and see the sequence alignments below). Regarding the property of having antimicrobial activity against Streptococcus mutans, the Streptococcus salivarius strain comprising the megaplasmid LAB813 has antimicrobial activity against Streptococcus mutans, as evidenced by Goldberg (see Abstract). The reference of Gong does not disclose deleting the endogenous manL gene. Pelletier discloses that Streptococcus salivarius comprising a deletion of its endogenous ManL gene do not take up 2-deoxyglucose (2-DG) and therefore is resistant to 2-DG (abstract and last paragraph at page 1612). Use of 2-DG resistant strains, including Streptococcus salivarius, as a positive selection marker was well known in the art, see Gauthier (Abstract and pages 1105-1106). Therefore, in combining the above references, it would have been obvious to one having ordinary skill in the art before the time the claimed invention was effectively filed to delete the endogenous ManL gene in the Streptococcus salivarius strain of Gong. One having ordinary skill in the art would have been motivated to do so in order to use the Streptococcus salivarius strain of Gong as a positive 2-DG selection marker. One having ordinary skill in the art would have has a reasonable expectation of success since Pelletier discloses deleting the endogenous ManL gene in Streptococcus salivarius. Therefore, the above references render claims 1-2 prima facie obvious. 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. Withdrawn Rejection Applicant’s arguments, see page 19 of the Remarks, filed September 19, 2025, with respect to the rejection(s) of claim(s) 1, 6-7, 9, and 12 under 35 U.S.C. 101 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Gong (Complete Genome Sequence of Megaplasmid-Bearing Streptococcus salivarius Strain LAB813, Isolated from the Dental Plaque of a Caries-Free Child. Microbiol. Resour. Announc. 2019, 8, e01092-19 – form PTO-892). New Rejection Claims 1, 6-7, 9, 12, and 33 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. Claim interpretation Regarding claims 1, 6-7, and 9, Gong discloses Streptococcus salivaris strain comprising the megaplasmid LAB813 (183,700 base pair) isolated from the dental plaque biofilm of a caries-free child with healthy oral tissues (page 1 of Gong and page 10 lines 6-9 of the instant specification), wherein the nucleic acid sequence is disclosed in CP040803 (abstract, pages 1-2). The Streptococcus salivaris strain expresses four lantibiotic salivaricn M peptides having 100% sequence identity to Pep1-Pep4 of SEQ ID NO:5-8, respectively, of the instant application, as evidenced by CP040803 (pages 1-3 and see the sequence alignments below). Regarding the property of having antimicrobial activity against Streptococcus mutans, the Streptococcus salivaris strain comprising the megaplasmid LAB813 has antimicrobial activity against Streptococcus mutans, as evidenced by Goldberg (see Abstract). Regarding claim 12, since the Streptococcus salivaris strain comprising the megaplasmid LAB813 has antimicrobial activity against Streptococcus mutans, a major cariogenic bacterial species, the Streptococcus salivaris strain comprising the megaplasmid LAB813 has caries prevention activity. Regarding claim 33, MPEP 2111.02.II. states that “statements in the preamble reciting the purpose or intended use of the claimed invention must be evaluated to determine whether or not the recited purpose or intended use results in a structural difference (or, in the case of process claims, manipulative difference) between the claimed invention and the prior art. If so, the recitation serves to limit the claim..”. In the instant case, the recited intended use “for preventing or treating streptococcal throat infections and/or periodontal diseases” do not result in a structural different between the claimed strain and the strain of the prior art. Therefore, the recitation does not limit claim 33. Therefore, claims 1, 6-7, 9, 12, and 33 are directed to a nature-based product, Streptococcus salivaris strain comprising the megaplasmid LAB813 CP040803 (“Streptococcus salivaris LAB813”). Step 1: This part of the eligibility analysis evaluates whether the claim falls within any statutory category (see MPEP 2106.03). Since the claims are directed to an isolated Streptococcus salivaris, the claims are directed to a composition of matter, which is one of the statutory categories of invention. (Step 1: YES) Step 2A Prong 1: This part of the eligibility analysis evaluates whether the claim recites a judicial exception (see MPEP 2106.04). The claimed isolated Streptococcus salivaris is not considered to have markedly different characteristics from what occurs in nature, a naturally occurring Streptococcus salivaris LAB813 isolated from the dental plaque biofilm of a caries-free child with healthy oral tissues, and is considered to be a law of nature exception. There is no indication in the specification or in the prior art that isolating the Streptococcus salivaris results in the Streptococcus salivaris having any characteristics (structural, functional, or otherwise) that are different from the naturally occurring Streptococcus salivaris LAB813. Because there is no difference in characteristics (structural, functional, or otherwise) between the claimed Streptococcus salivaris and the naturally occurring Streptococcus salivaris LAB813, the claimed Streptococcus salivaris is directed to a judicial exception. Step 2A Prong 2: This part of the eligibility analysis evaluates whether the claim as a whole integrates the recited judicial exception into a practical application (see MPEP 2106.04(d)). This evaluation is performed by (a) identifying whether there are any additional recited elements in the claim beyond the judicial exception and (b) evaluating those additional elements individually and in combination to determine whether the claim as a whole integrates the exception into a practical application. There are no additional elements recited in the claims beyond the judicial exception. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claimed Streptococcus salivaris is found naturally occurring in nature (Streptococcus salivaris LAB813). (Step2 A: YES) Step 2B: This part of the eligibility analysis evaluates whether the claim as a whole amounts to significantly more than the recited exception, i.e., whether any additional element, or combination of additional elements, adds an inventive concept to the claim (see MPEP § 2106.05). The claim only recites the laws of nature and do not include any additional elements that could add significantly more to the judicial exceptions. (Step 2B: NO). As such, the claims do not qualify as eligible subject matter. Conclusion Claims 1-2, 6-9, 12, 15-26, and 33 are pending. Claims 15-26 are withdrawn. Claims 1-2, 6-9, 12, and 33 are rejected. Any inquiry concerning this communication or earlier communications from the examiner should be directed to YONG D PAK whose telephone number is (571)272-0935. The examiner can normally be reached M-Th: 5:30 am - 3:30 pm. 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, Robert Mondesi can be reached on 408-918-7584. 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. /YONG D PAK/Primary Examiner, Art Unit 1652 Sequence alignment between Pep1 of SEQ ID NO:5 of the instant application (“Qy”) and the Lantibiotic salivaricin M peptide of GenBank CP040803 (“Db”) A0A0S2IJA2_STRSL ID A0A0S2IJA2_STRSL Unreviewed; 60 AA. AC A0A0S2IJA2; DT 17-FEB-2016, integrated into UniProtKB/TrEMBL. DT 17-FEB-2016, sequence version 1. DT 28-JAN-2026, entry version 15. DE SubName: Full=Lantibiotic salivaricin M {ECO:0000313|EMBL:QEM31433.1}; DE SubName: Full=SrnA {ECO:0000313|EMBL:ALO23662.1}; GN Name=srnA' {ECO:0000313|EMBL:ALO23662.1}; GN ORFNames=FHI56_00035 {ECO:0000313|EMBL:QEM31433.1}, FHI56_00865 GN {ECO:0000313|EMBL:QEM31569.1}; OS Streptococcus salivarius. OG Plasmid pSAL813 {ECO:0000313|EMBL:QEM31433.1}, and OG Plasmid psal813 {ECO:0000313|Proteomes:UP000322622}. OC Bacteria; Bacillati; Bacillota; Bacilli; Lactobacillales; Streptococcaceae; OC Streptococcus. OX NCBI_TaxID=1304 {ECO:0000313|EMBL:ALO23662.1}; RN [1] {ECO:0000313|EMBL:ALO23662.1} RP NUCLEOTIDE SEQUENCE. RC STRAIN=JH {ECO:0000313|EMBL:ALO23662.1}; RA Walker G.V., Wescombe P.A., Heng N.C.K., Tagg J.R.; RT "Salivaricin E and abundant dextranase activity may contribute to the anti- RT cariogenic potential of the probiotic candidate Streptococcus salivarius RT JH."; RL Submitted (JUN-2015) to the EMBL/GenBank/DDBJ databases. RN [2] {ECO:0000313|EMBL:QEM31433.1, ECO:0000313|Proteomes:UP000322622} RP NUCLEOTIDE SEQUENCE [LARGE SCALE GENOMIC DNA]. RC STRAIN=LAB813 {ECO:0000313|EMBL:QEM31433.1, RC ECO:0000313|Proteomes:UP000322622}; RC PLASMID=psal813 {ECO:0000313|Proteomes:UP000322622}, and pSAL813 RC {ECO:0000313|EMBL:QEM31433.1}; RA Levesque C.M., Gong S.-G., Dufour D., Barbour A.; RT "Complete genome sequence of Streptococcus salivarius LAB813."; RL Submitted (JUN-2019) to the EMBL/GenBank/DDBJ databases. CC --------------------------------------------------------------------------- CC Copyrighted by the UniProt Consortium, see https://www.uniprot.org/terms CC Distributed under the Creative Commons Attribution (CC BY 4.0) License CC --------------------------------------------------------------------------- DR EMBL; KT032116; ALO23662.1; -; Genomic_DNA. DR EMBL; CP040803; QEM31433.1; -; Genomic_DNA. DR EMBL; CP040803; QEM31569.1; -; Genomic_DNA. DR RefSeq; WP_149561018.1; NZ_CP040803.1. DR AlphaFoldDB; A0A0S2IJA2; -. DR Proteomes; UP000322622; Plasmid pSAL813. DR NCBIfam; NF040663; salivaricin_M; 1. PE 4: Predicted; KW Plasmid {ECO:0000313|EMBL:QEM31433.1}. SQ SEQUENCE 60 AA; 6535 MW; E1E617CFEC7DBC1D CRC64; Query Match 100.0%; Score 324; Length 60; Best Local Similarity 100.0%; Matches 60; Conservative 0; Mismatches 0; Indels 0; Gaps 0; Qy 1 MAKNTSRPEIDSLSFEVENQELSGKSGSGWFTAVQLTLAGRCGRWFTGSFECTTNNVKCG 60 |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||| Db 1 MAKNTSRPEIDSLSFEVENQELSGKSGSGWFTAVQLTLAGRCGRWFTGSFECTTNNVKCG 60 Sequence alignment between Pep2 of SEQ ID NO:6 of the instant application (“Qy”) and the Lantibiotic salivaricin M peptide of GenBank CP040803 (“Db”) A0A0S2IJ22_STRSL ID A0A0S2IJ22_STRSL Unreviewed; 60 AA. AC A0A0S2IJ22; DT 17-FEB-2016, integrated into UniProtKB/TrEMBL. DT 17-FEB-2016, sequence version 1. DT 28-JAN-2026, entry version 15. DE SubName: Full=Lantibiotic salivaricin M {ECO:0000313|EMBL:QEM31432.1}; DE SubName: Full=SrnA {ECO:0000313|EMBL:ALO23661.1}; GN Name=srnA {ECO:0000313|EMBL:ALO23661.1}; GN ORFNames=FHI56_00030 {ECO:0000313|EMBL:QEM31432.1}, FHI56_00860 GN {ECO:0000313|EMBL:QEM31568.1}; OS Streptococcus salivarius. OG Plasmid pSAL813 {ECO:0000313|EMBL:QEM31432.1}, and OG Plasmid psal813 {ECO:0000313|Proteomes:UP000322622}. OC Bacteria; Bacillati; Bacillota; Bacilli; Lactobacillales; Streptococcaceae; OC Streptococcus. OX NCBI_TaxID=1304 {ECO:0000313|EMBL:ALO23661.1}; RN [1] {ECO:0000313|EMBL:ALO23661.1} RP NUCLEOTIDE SEQUENCE. RC STRAIN=JH {ECO:0000313|EMBL:ALO23661.1}; RA Walker G.V., Wescombe P.A., Heng N.C.K., Tagg J.R.; RT "Salivaricin E and abundant dextranase activity may contribute to the anti- RT cariogenic potential of the probiotic candidate Streptococcus salivarius RT JH."; RL Submitted (JUN-2015) to the EMBL/GenBank/DDBJ databases. RN [2] {ECO:0000313|EMBL:QEM31432.1, ECO:0000313|Proteomes:UP000322622} RP NUCLEOTIDE SEQUENCE [LARGE SCALE GENOMIC DNA]. RC STRAIN=LAB813 {ECO:0000313|EMBL:QEM31432.1, RC ECO:0000313|Proteomes:UP000322622}; RC PLASMID=pSAL813 {ECO:0000313|EMBL:QEM31432.1}, and psal813 RC {ECO:0000313|Proteomes:UP000322622}; RA Levesque C.M., Gong S.-G., Dufour D., Barbour A.; RT "Complete genome sequence of Streptococcus salivarius LAB813."; RL Submitted (JUN-2019) to the EMBL/GenBank/DDBJ databases. CC --------------------------------------------------------------------------- CC Copyrighted by the UniProt Consortium, see https://www.uniprot.org/terms CC Distributed under the Creative Commons Attribution (CC BY 4.0) License CC --------------------------------------------------------------------------- DR EMBL; KT032116; ALO23661.1; -; Genomic_DNA. DR EMBL; CP040803; QEM31432.1; -; Genomic_DNA. DR EMBL; CP040803; QEM31568.1; -; Genomic_DNA. DR RefSeq; WP_149561017.1; NZ_CP040803.1. DR AlphaFoldDB; A0A0S2IJ22; -. DR Proteomes; UP000322622; Plasmid pSAL813. DR NCBIfam; NF040663; salivaricin_M; 1. PE 4: Predicted; KW Plasmid {ECO:0000313|EMBL:QEM31432.1}. SQ SEQUENCE 60 AA; 6749 MW; 2369460D1AA8A838 CRC64; Query Match 100.0%; Score 330; Length 60; Best Local Similarity 100.0%; Matches 60; Conservative 0; Mismatches 0; Indels 0; Gaps 0; Qy 1 MRKNNNRKEIDTLDFEVKNQELSGKSGSGWFTAVQLTLAGRCGRWFTGSYECTTNNVKCG 60 |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||| Db 1 MRKNNNRKEIDTLDFEVKNQELSGKSGSGWFTAVQLTLAGRCGRWFTGSYECTTNNVKCG 60 Sequence alignment between Pep3 of SEQ ID NO:7 of the instant application (“Qy”) and the Lantibiotic salivaricin M peptide of GenBank CP040803 (“Db”) A0A0S2IK08_STRSL ID A0A0S2IK08_STRSL Unreviewed; 60 AA. AC A0A0S2IK08; DT 17-FEB-2016, integrated into UniProtKB/TrEMBL. DT 17-FEB-2016, sequence version 1. DT 28-JAN-2026, entry version 16. DE SubName: Full=Lantibiotic salivaricin M {ECO:0000313|EMBL:QEM31431.1}; DE SubName: Full=SrnA {ECO:0000313|EMBL:ALO23663.1}; GN Name=srnA'' {ECO:0000313|EMBL:ALO23663.1}; GN ORFNames=FHI56_00025 {ECO:0000313|EMBL:QEM31431.1}, FHI56_00855 GN {ECO:0000313|EMBL:QEM31567.1}; OS Streptococcus salivarius. OG Plasmid pSAL813 {ECO:0000313|EMBL:QEM31431.1}, and OG Plasmid psal813 {ECO:0000313|Proteomes:UP000322622}. OC Bacteria; Bacillati; Bacillota; Bacilli; Lactobacillales; Streptococcaceae; OC Streptococcus. OX NCBI_TaxID=1304 {ECO:0000313|EMBL:ALO23663.1}; RN [1] {ECO:0000313|EMBL:ALO23663.1} RP NUCLEOTIDE SEQUENCE. RC STRAIN=JH {ECO:0000313|EMBL:ALO23663.1}; RA Walker G.V., Wescombe P.A., Heng N.C.K., Tagg J.R.; RT "Salivaricin E and abundant dextranase activity may contribute to the anti- RT cariogenic potential of the probiotic candidate Streptococcus salivarius RT JH."; RL Submitted (JUN-2015) to the EMBL/GenBank/DDBJ databases. RN [2] {ECO:0000313|EMBL:QEM31431.1, ECO:0000313|Proteomes:UP000322622} RP NUCLEOTIDE SEQUENCE [LARGE SCALE GENOMIC DNA]. RC STRAIN=LAB813 {ECO:0000313|EMBL:QEM31431.1, RC ECO:0000313|Proteomes:UP000322622}; RC PLASMID=psal813 {ECO:0000313|Proteomes:UP000322622}, and pSAL813 RC {ECO:0000313|EMBL:QEM31431.1}; RA Levesque C.M., Gong S.-G., Dufour D., Barbour A.; RT "Complete genome sequence of Streptococcus salivarius LAB813."; RL Submitted (JUN-2019) to the EMBL/GenBank/DDBJ databases. CC --------------------------------------------------------------------------- CC Copyrighted by the UniProt Consortium, see https://www.uniprot.org/terms CC Distributed under the Creative Commons Attribution (CC BY 4.0) License CC --------------------------------------------------------------------------- DR EMBL; KT032116; ALO23663.1; -; Genomic_DNA. DR EMBL; CP040803; QEM31431.1; -; Genomic_DNA. DR EMBL; CP040803; QEM31567.1; -; Genomic_DNA. DR RefSeq; WP_114865144.1; NZ_CP040803.1. DR AlphaFoldDB; A0A0S2IK08; -. DR Proteomes; UP000322622; Plasmid pSAL813. DR NCBIfam; NF040663; salivaricin_M; 1. PE 4: Predicted; KW Plasmid {ECO:0000313|EMBL:QEM31431.1}. SQ SEQUENCE 60 AA; 6779 MW; 4CAFD2C7FA87CE87 CRC64; Query Match 100.0%; Score 340; Length 60; Best Local Similarity 100.0%; Matches 60; Conservative 0; Mismatches 0; Indels 0; Gaps 0; Qy 1 MKSKKVNTEIDTLEFEIDNQELNGTSGSGWWYTAFKMTLAGRCGLCFTCSYECTTNNVHC 60 |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||| Db 1 MKSKKVNTEIDTLEFEIDNQELNGTSGSGWWYTAFKMTLAGRCGLCFTCSYECTTNNVHC 60 Sequence alignment between Pep4 of SEQ ID NO:8 of the instant application (“Qy”) and the Lantibiotic salivaricin M peptide of GenBank CP040803 (“Db”) A0AB37CJZ2_STRSL ID A0AB37CJZ2_STRSL Unreviewed; 58 AA. AC A0AB37CJZ2; DT 05-FEB-2025, integrated into UniProtKB/TrEMBL. DT 05-FEB-2025, sequence version 1. DT 28-JAN-2026, entry version 3. DE SubName: Full=Lantibiotic salivaricin M {ECO:0000313|EMBL:QEM31430.1}; GN ORFNames=FHI56_00020 {ECO:0000313|EMBL:QEM31430.1}, FHI56_00850 GN {ECO:0000313|EMBL:QEM31566.1}; OS Streptococcus salivarius. OG Plasmid pSAL813 {ECO:0000313|EMBL:QEM31430.1}, and OG Plasmid psal813 {ECO:0000313|Proteomes:UP000322622}. OC Bacteria; Bacillati; Bacillota; Bacilli; Lactobacillales; Streptococcaceae; OC Streptococcus. OX NCBI_TaxID=1304 {ECO:0000313|EMBL:QEM31430.1, ECO:0000313|Proteomes:UP000322622}; RN [1] {ECO:0000313|EMBL:QEM31430.1, ECO:0000313|Proteomes:UP000322622} RP NUCLEOTIDE SEQUENCE [LARGE SCALE GENOMIC DNA]. RC STRAIN=LAB813 {ECO:0000313|EMBL:QEM31430.1, RC ECO:0000313|Proteomes:UP000322622}; RC PLASMID=psal813 {ECO:0000313|Proteomes:UP000322622}, and pSAL813 RC {ECO:0000313|EMBL:QEM31430.1}; RA Levesque C.M., Gong S.-G., Dufour D., Barbour A.; RT "Complete genome sequence of Streptococcus salivarius LAB813."; RL Submitted (JUN-2019) to the EMBL/GenBank/DDBJ databases. CC --------------------------------------------------------------------------- CC Copyrighted by the UniProt Consortium, see https://www.uniprot.org/terms CC Distributed under the Creative Commons Attribution (CC BY 4.0) License CC --------------------------------------------------------------------------- DR EMBL; CP040803; QEM31430.1; -; Genomic_DNA. DR EMBL; CP040803; QEM31566.1; -; Genomic_DNA. DR RefSeq; WP_149561016.1; NZ_CP040803.1. DR AlphaFoldDB; A0AB37CJZ2; -. DR Proteomes; UP000322622; Plasmid pSAL813. DR NCBIfam; NF040663; salivaricin_M; 1. PE 4: Predicted; KW Plasmid {ECO:0000313|EMBL:QEM31430.1}. SQ SEQUENCE 58 AA; 6588 MW; 50B07A1460011044 CRC64; Query Match 100.0%; Score 326; Length 58; Best Local Similarity 100.0%; Matches 58; Conservative 0; Mismatches 0; Indels 0; Gaps 0; Qy 1 MKQDNFEIDSLDYEINSQELNGKSAAGWSTAVRLTVQGRCGWWFTHSYECTSPNVRCG 58 |||||||||||||||||||||||||||||||||||||||||||||||||||||||||| Db 1 MKQDNFEIDSLDYEINSQELNGKSAAGWSTAVRLTVQGRCGWWFTHSYECTSPNVRCG 58
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Prosecution Timeline

Feb 10, 2023
Application Filed
Mar 20, 2025
Non-Final Rejection mailed — §101, §102, §103
Sep 19, 2025
Response Filed
Jun 18, 2026
Non-Final Rejection mailed — §101, §102, §103 (current)

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Prosecution Projections

2-3
Expected OA Rounds
75%
Grant Probability
89%
With Interview (+14.1%)
2y 10m (~0m remaining)
Median Time to Grant
Moderate
PTA Risk
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