Prosecution Insights
Last updated: April 19, 2026
Application No. 17/294,196

ORAL WASH FOR ORAL FLUID COLLECTION AND ANALYSIS AND METHODS OF USE THEREOF

Final Rejection §101§102§103
Filed
May 14, 2021
Examiner
CRAIG, KAILA ANGELIQUE
Art Unit
1618
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Decima Diagnostics LLC
OA Round
4 (Final)
33%
Grant Probability
At Risk
5-6
OA Rounds
3y 5m
To Grant
67%
With Interview

Examiner Intelligence

Grants only 33% of cases
33%
Career Allow Rate
20 granted / 60 resolved
-26.7% vs TC avg
Strong +34% interview lift
Without
With
+33.7%
Interview Lift
resolved cases with interview
Typical timeline
3y 5m
Avg Prosecution
49 currently pending
Career history
109
Total Applications
across all art units

Statute-Specific Performance

§101
2.0%
-38.0% vs TC avg
§103
50.1%
+10.1% vs TC avg
§102
16.9%
-23.1% vs TC avg
§112
22.1%
-17.9% vs TC avg
Black line = Tech Center average estimate • Based on career data from 60 resolved cases

Office Action

§101 §102 §103
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 Status of Claims Cancelled: 2, 3 Withdrawn: 5, 10-18 Examined Herein: 1, 4, 6-9, 19 Priority Priority to PRO 62/768,501 filed on 11/16/2018 and PCT/US2019/062010 filed on 11/18/2019 is acknowledged. Information Disclosure Statement The information disclosure statement (IDS) submitted on 10/4/2022 and 1/15/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. Withdrawn Rejections All rejections of claim 2 are hereby withdrawn. Its cancellation moots the rejections. [Remarks 12/9/2025, Page 5] The rejection of claims 1, 2, 4, 6-9, and 19 under 35 U.S.C. 112(b) is hereby withdrawn in view of Applicant’s amendments which removes the phrase “suitable for rinsing an oral cavity of a human subject,” thereby mooting the rejection. [Remarks 12/9/2025, Page 6] The rejection of claims 1, 2, 6-9, and 19 under 35 U.S.C. 101 is hereby withdrawn in view of Applicant’s amendments to claim 1, which now recites claim elements that are not merely products of nature. [Remarks 12/9/2025, Page 7] The rejection of claims 1 and 6 under 35 U.S.C. 102(a)(1) over Park is hereby withdrawn in view of Applicant’s amendments to claim 1 and Applicant’s persuasive arguments that Park does not disclose the internal tracer is at a concentration that “produces a mass spectrometry signal that is distinguishable from background interference due to a monoisotopic form of the stable heavy isotope-labelled internal tracer.” [Remarks 12/9/2025, Page 10] The rejection of claims 1 and 6-9 under 35 U.S.C. 103 over Hu and Everson is hereby withdrawn in view of Applicant’s amendments to claim 1. [Remarks 12/9/2025, Page 11] The rejection of claims 1, 2, 4, 6, and 19 under 35 U.S.C. 103 over Sager and Everson is hereby withdrawn in view of Applicant’s amendments to claim 1 and Applicant’s persuasive arguments that Sager and Everson do not disclose the internal tracer is at a concentration that “produces a mass spectrometry signal that is distinguishable from background interference due to a monoisotopic form of the stable heavy isotope-labelled internal tracer.” [Remarks 12/9/2025, Page 13-15] Claim Rejections - 35 USC § 102 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. Claims 1 and 7 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Everson (US 2010/0055734 A1, Published 3/4/2010). With respect to claim 1, Everson discloses a composition comprising a saliva stimulating agent, sodium bicarbonate, and a stable heavy isotope-labelled internal tracer, 2,2,4,4-2H-cholic acid. Everson discloses the 2,2,4,4-2H-cholic acid is present at a concentration of about 4 mg/mL, which is a concentration that is detectable by mass spectrometry. [Everson, 0251] An internal tracer that is at least 3 Da higher than that of the natural compound is distinguishable from background interference due to a monoisotopic form of the tracer. 2,2,4,4-2H-cholic acid contains 4 deuterium atoms and is 4 Da higher than cholic acid. Accordingly, 2,2,4,4-2H-cholic acid necessarily produces a mass spectrometry signal that is distinguishable from background interference due to a monoisotopic form that is at least 3 Da less than the tracer. The tracer is not tartrazine and the tracer comprises a heavy isotope, 2H. [Everson, 0251] The limitation “wherein the oral wash composition is for rinsing an oral cavity of a human subject and subsequent collection therefrom” recites an intended use. A recitation of an intended use must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Sodium bicarbonate and cholic acid are non-toxic components that are capable of being placed into the oral cavity of a human subject and subsequent collection therefrom. Therefore, the limitations of claim 1 have been met. With respect to claim 7, Everson discloses the composition further comprises a sweetening agent/flavor-enhancing agent, grape or apple juice, thus meeting the limitations of claim 7. [Everson, 0251] Claims 1 and 19 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Gao (US 2002/0168775 A1, Published 11/14/2002). With respect to claim 1, Gao discloses a composition comprising an internal standard selected from beclomethasone, d3-bupivacaine, d9-bupivacaine, flumethasone, or pentylcaine and a solvent selected from methanol, acetonitrile, and distilled water. Accordingly, Gao discloses an embodiment of a composition comprising a saliva stimulating agent, distilled water, and a stable heavy isotope-labelled internal tracer, d9-bupivacine. Gao does not expressly disclose this specific combination as arranged in the claim. However, one of ordinary skill in the art would ‘at once envisage’ the claimed composition in view of the finite number of internal standards and solvents specifically named by Gao. [Gao, 0046] Gao discloses the tracer is present at a concentration of 100 ng/mL, which is a concentration that is detectable by mass spectrometry. [Gao, 0046] An internal tracer that is at least 3 Da higher than that of the natural compound is distinguishable from background interference due to a monoisotopic form of the tracer. d9-bupivacaine contains 9 deuterium atoms and has a monoisotopic mass about 9 Da greater than bupivacaine. Accordingly, d9-bupivacaine necessarily produces a mass spectrometry signal that is distinguishable from background interference due to a monoisotopic form that is at least 3 Da less than the tracer. The tracer is not tartrazine and the tracer comprises a heavy isotope, 2H. [Gao, 0046] The limitation “wherein the oral wash composition is for rinsing an oral cavity of a human subject and subsequent collection therefrom” recites an intended use. A recitation of an intended use must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Distilled water and bupivacaine are non-toxic components are capable of being placed into the oral cavity of a human subject and subsequent collection therefrom. Therefore, the limitations of claim 1 have been met. With respect to claim 19, Gao discloses the tracer is present at a concentration of 100 ng/mL. [Gao, 0046] 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. Claims 1, 6, and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Everson, in view of Griep-Raming (US 2018/0226238 A1, Published 8/9/2019). With respect to claim 1, Everson discloses a composition comprising a saliva stimulating agent, sodium bicarbonate, and caffeine. Everson discloses the caffeine is present at a concentration of about 7.5 mg/mL, which is a concentration detectable by mass spectrometry. [Everson, 0138-0139] Everson further discloses the caffeine that is present in the composition may be “distinguishable” caffeine. Everson defines distinguishable caffeine as caffeine linked to different distinguishable isotopes (e.g. stable isotopes: 13C, 2H, 15N). [Everson, 0110] With respect to claim 7, Everson discloses the composition further comprises a sweetening agent/flavor-enhancing agent, grape or apple juice. [Everson, 0138-0139] Everson does not disclose the composition comprises a stable heavy isotope-labelled internal tracer. However, with respect to claim 1 and 6, Griep-Raming discloses caffeine isotopologues including 13C-caffeine, 18O-caffeine, 13C2-caffeine, 13C,2H-caffeine, 13C15N2-caffeine, and 15N2-caffeine. [Griep-Raming, 0123-0124 and Figure 6] Griep-Raming further discloses these isotopologues produce a mass spectrometry signal that is distinguishable from background interference due to a monoisotopic form of caffeine. [Griep-Raming, Figure 6] Griep-Raming additionally discloses the isotopologues comprise a heavy isotope, 2H, 13C, or 15N. [Griep-Raming, 0123-0124] Modifying the composition disclosed by Everson by replacing the monoisotopic caffeine with 13C-caffeine, 13C2-caffeine, 13C,2H-caffeine, or 13C15N2-caffeine, results in the composition of claim 1 comprising: A saliva stimulating agent, sodium carbonate, and a stable heavy isotope-labelled internal tracer, 13C-caffeine, 13C2-caffeine, 13C,2H-caffeine, or 13C15N2-caffeine. The tracer is present at a concentration of about 7.5 mg/mL, which is detectable by mass spectrometry and the tracer produces a mass spectrometry signal that is distinguishable from background interference due to a monoisotopic form of the tracer. The tracer is not tartrazine and comprises a heavy isotope, 2H, 13C, or 15N. Moreover, the limitation “wherein the oral wash composition is suitable for rinsing an oral cavity of a human subject and subsequent collection therefrom” recites an intended use. A recitation of intended use must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Sodium carbonate and caffeine are non-toxic components and capable of being placed into the oral cavity of a human subject and subsequent collection therefrom. Accordingly, with respect to claim 6, Everson and Griep-Raming disclose the tracer comprises 13C. It would be obvious to one of ordinary skill in the art to modify the composition disclosed by Everson by replacing the monoisotopic caffeine with 13C-caffeine, 13C2-caffeine, 13C,2H-caffeine, or 13C15N2-caffeine and have a reasonable expectation of success. Everson discloses a composition comprising a saliva stimulating agent and caffeine. Everson further discloses the caffeine present in the composition may be “distinguishable” caffeine, or caffeine linked to a distinguishable isotope (e.g. stable isotopes: 13C, 2H, 15N). Griep-Raming discloses several species of caffeine linked to a distinguishable isotope including 13C-caffeine, 13C2-caffeine, 13C,2H-caffeine, and 13C15N2-caffeine. Thus, the combined teachings of Everson and Griep-Raming suggest that the caffeine present in the composition disclosed by Everson may be 13C-caffeine, 13C2-caffeine, 13C,2H-caffeine, or 13C15N2-caffeine. Therefore, it is reasonable to expect the composition disclosed by Everson may be modified by replacing caffeine with 13C-caffeine, 13C2-caffeine, 13C,2H-caffeine, or 13C15N2-caffeine. One would have been motivated to do so because it is prima facie obvious to combine references when some advantage or expected beneficial result would have been produced by their combination. MPEP 2144(II) In the instant case, Everson discloses distinguishable agents may be metabolically tracked by assessing saliva samples in a subject. [Everson, 0110] Therefore, one would have been motivated by the expectation that the aforementioned modification could enable the composition disclosed by Everson to be used to assess the metabolism of a subject. Claims 1, 4, 6, and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Everson, in view of Cambridge Isotope Laboratories, Inc. (hereinafter “Cambridge”) (Stable Isotope-Labeled Products for Metabolomics, 9/6/2018, Eurisotop - A Cambridge Isotope Laboratories Company). With respect to claim 1, Everson discloses a composition comprising a saliva stimulating agent, sodium bicarbonate, and caffeine. Everson discloses the caffeine is present at a concentration of about 7.5 mg/mL, which is detectable by mass spectrometry. [Everson, 0138-0139] Everson further discloses the caffeine present in the composition may be “distinguishable” caffeine. Everson defines distinguishable caffeine as caffeine linked to different distinguishable isotopes (e.g. stable isotopes: 13C, 2H, 15N). [Everson, 0110] With respect to claim 7, Everson discloses the composition further comprises a sweetening agent/flavor-enhancing agent, grape or apple juice. [Everson, 0138-0139] Everson does not disclose the composition comprises a stable heavy isotope-labelled internal tracer. However, with respect to claim 1, 4, and 6, Cambridge discloses a caffeine isotopologue, caffeine (trimethyl-13C3), comprising caffeine linked to 13C. [Cambridge, Page 6, “Caffeine and Metabolites”] An internal tracer that is at least 3 Da higher than that of the natural compound is distinguishable from background interference due to a monoisotopic form of the tracer. Caffeine (trimethyl-13C3) contains three 13C atoms and has a monoisotopic mass about 3 Da greater than caffeine. Accordingly, caffeine (trimethyl-13C3) necessarily produces a mass spectrometry signal that is distinguishable from background interference due to a monoisotopic form that is at least 3 Da less than the tracer. Modifying the composition disclosed by Everson by replacing the monoisotopic caffeine with caffeine (trimethyl-13C3), results in the composition of claim 1 comprising: A saliva stimulating agent, sodium carbonate, and a stable heavy isotope-labelled internal tracer, caffeine (trimethyl-13C3). The tracer is present at a concentration of about 7.5 mg/mL, which is detectable by mass spectrometry and the tracer produces a mass spectrometry signal that is distinguishable from background interference due to a monoisotopic form. The tracer is not tartrazine and comprises a heavy isotope, 13C, or 15N. Moreover, the limitation “wherein the oral wash composition is suitable for rinsing an oral cavity of a human subject and subsequent collection therefrom” recites an intended use. A recitation of intended use must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Sodium carbonate and caffeine are non-toxic components and are capable of being placed into the oral cavity of a human subject and subsequent collection therefrom. Accordingly, with respect to claim 4, Everson and Cambridge disclose the tracer is caffeine-13C3. With respect to claim 6, Everson and Cambridge disclose the tracer comprises 13C. It would be obvious to one of ordinary skill in the art to modify the composition disclosed by Everson by replacing the monoisotopic caffeine with caffeine (trimethyl-13C3) and have a reasonable expectation of success. Everson discloses a composition comprising a saliva stimulating agent and caffeine. Everson further discloses the caffeine present in the composition may be “distinguishable” caffeine, or caffeine linked to a distinguishable isotope (e.g. stable isotopes: 13C, 2H, 15N). Cambridge discloses a caffeine isotopologue, caffeine (trimethyl-13C3), comprising caffeine linked to 13C. Thus, the combined teachings of Everson and Cambridge suggest that the caffeine present in the composition disclosed by Everson may be caffeine (trimethyl-13C3). Therefore, it is reasonable to expect the composition disclosed by Everson may be modified by replacing caffeine with caffeine (trimethyl-13C3). One would have been motivated to do so because it is prima facie obvious to combine references when some advantage or expected beneficial result would have been produced by their combination. MPEP 2144(II) In the instant case, Everson discloses distinguishable agents may be metabolically tracked by assessing saliva samples in a subject. [Everson, 0110] Therefore, one would have been motivated by the expectation that the aforementioned modification could enable the composition disclosed by Everson to be used to assess the metabolism of a subject. Claims 1 and 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Hu (US 2020/0124609 A1, Filed 10/19/2018), in view of Cambridge. With respect to claim 1, Hu discloses a composition comprising a saliva stimulating agent, vitamin C, and galactose. [Hu, 0017, 0041, Table 3, Formula 14] Hu discloses the caffeine is present at a concentration of about 40 mg/mL, which is detectable by mass spectrometry. [Hu, 0041] With respect to claim 7, Hu discloses the composition further comprises a flavor enhancer, citrate buffer. [Hu, 0041, Table 3, Formula 14] With respect to claim 8 and 9, Hu discloses the composition has a pH of 4.5. [Hu, 0017, 0041, Table 3, Formula 14] Hu further discloses the galactose present in the composition may be a stable isotope and/or D-galactose. [Hu, 0017, 0033] Hu does not disclose the composition comprises a stable heavy isotope-labelled internal tracer. However, with respect to claim 1 and 6, Cambridge discloses D-Galactose-13C6 is a stable isotope of galactose. [Cambridge, Page 7, Col. 1] An internal tracer that is at least 3 Da higher than that of the natural compound is distinguishable from background interference due to a monoisotopic form of the tracer. D-Galactose-13C6 contains six 13C atoms and has a monoisotopic mass about 6 Da greater than bupivacaine. Accordingly, D-Galactose-13C6 necessarily produces a mass spectrometry signal that is distinguishable from background interference due to a monoisotopic form that is at least 3 Da less than the tracer. Modifying the composition disclosed by Hu by replacing galactose with D-Galactose-13C6 results in the composition of claim 1 and 6 comprising: a saliva stimulating agent, vitamin C, and a stable heavy isotope-labelled internal tracer, D-galactose-13C6. The tracer is present at a concentration of about 40 mg/mL, which is detectable by mass spectrometry and the tracer produces a mass spectrometry signal that is distinguishable from background interference due to a monoisotopic form. The tracer is not tartrazine and comprises a heavy isotope, 13C. Moreover, the limitation “wherein the oral wash composition is suitable for rinsing an oral cavity of a human subject and subsequent collection therefrom” recites an intended use. A recitation of intended use must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Vitamin C and galactose are non-toxic components and are capable of being placed into the oral cavity of a human subject and subsequent collection therefrom. It would be obvious to one of ordinary skill in the art to modify the composition disclosed by Hu by replacing galactose with D-Galactose-13C6 and have a reasonable expectation of success. Hu discloses a composition comprising a saliva stimulating agent and galactose. Hu further discloses the galactose may be present in the composition as a stable isotope and/or D-galactose. Cambridge discloses the compound, D-Galactose-13C6, which is a D configuration of galactose comprising a stable isotope. Thus, the combined teachings of Hu and Cambridge suggest that D-Galactose-13C6 may function as the stable isotope of D-galactose in the composition disclosed by Hu. Therefore, it is reasonable to expect the composition disclosed by Hu may be modified by replacing galactose with D-Galactose-13C6. One would have been motivated to do so because the selection of a known material based on its suitability for its intended use is prima facie obvious. MPEP 2144.07 In the instant case, Hu discloses galactose may be present in the composition as D-galactose and/or a stable isotope galactose. [Hu, 0017] Therefore, the selection of a known compound, D-galactose-13C6, based on its suitability as D-galactose and a stable isotope galactose for use in the composition disclosed by Hu is prima facie obvious. Response to Arguments Applicant’s arguments with respect to the rejection under 35 U.S.C. 101 have been fully considered and are persuasive. Accordingly, the rejection has been withdrawn. Applicant's arguments filed 12/9/2025 with respect to the rejection under 35 U.S.C 102(a)(1) and 102(a)(2) over Everson have been fully considered but they are not persuasive. Applicant asserts Everson fails to disclose the limitations of claim 1, as amended and “nothing in Everson discloses including 2,2,4,4-2H-cholic acid, or any other type of isotope, at a concentration that is capable of producing a mass spectrometry signal that is distinguishable from background interference due to a monoisotopic form of the same compound.” [Remarks 12/9/2025, Page 8, Paragraph 2-3] Applicant’s argument is not persuasive because the limitation “capable of producing a mass spectrometry signal that is distinguishable from background interference due to a monoisotopic form of the same compound” recites a property of the stable heavy isotope-labelled internal tracer. However, the claiming of a property which is inherently present in the prior art does not make the claim patentable. Everson discloses the tracer is present at a concentration that is detectable by mass spectrometry. Moreover, the ability of 2,2,4,4-2H-cholic acid to produce a mass spectrometry signal that is distinguishable from background interference due to a monoisotopic form of cholic acid is inherent to the tracer itself. This is at least evidenced by Sargent (Guide to achieving reliable quantitative LC-MS measurements, RSC Analytical Methods Committee, 2013. ISBN 978-0-948926-27-3). Sargent discloses a labelled compound should have a monoisotopic mass at least 3 Da higher than that of the natural compound to avoid spectral overlap. [Sargent, Page 48, Paragraph 2] Sargent further discloses a suitable mass spectrometer is able to separate masses that differ by one mass unit or less (typically 0.7 Da FWHM). [Sargent, Page 42, 6.7.1] Thus, 2,2,4,4-2H-cholic acid necessarily produce a mass spectrometry signal that is distinguishable from background interference due to a monoisotopic form of the same compound that is at least 3 Da less than the tracer. Therefore, Applicant is claiming an inherent characteristic of 2,2,4,4-2H-cholic acid that necessarily flows from Everson but this is not sufficient to overcome the anticipation rejection. Applicant asserts the following: “Moreover, the oral solution described at para. [0251] of Everson is ingested by the patient which is different than an oral wash composition for rinsing an oral cavity of a human subject and subsequent collection therefrom, as claimed. Accordingly, Everson cannot disclose a concentration for an oral composition that is for washing/rinsing and collection thereafter, as opposed to one that is meant to be ingested like Everson's.” [Remarks 12/9/2025, Page 8, Paragraph 4 – Page 9, Paragraph 1] “These tests are understood to be multi-isotope tests requiring at least two types of different isotopes and at least two different routes of administration (i.e., cholate clearance test) or administration at different times and dosages with metabolic tracking (i.e., liver metabolism assessment). [Remarks 12/9/2025, Page 9, Paragraph 9] Applicant's argument is based on an intended use of the claimed invention. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In the instant case, sodium bicarbonate and cholic acid are non-toxic components that are capable of being placed in the oral cavity into the oral cavity of a human subject and subsequent collection therefrom. Therefore, Everson meets the claimed limitations. Moreover, a reference may be directed to an entirely different problem than the one addressed by the inventor, or may be from an entirely different field of endeavor than that of the claimed invention, yet the reference is still anticipatory if it explicitly or inherently discloses every limitation recited in the claims. MPEP 2131.05 Thus, the difference in use between the claimed composition and the composition disclosed by Everson is immaterial because Everson explicitly and inherently discloses every limitation recited in the claims. Applicant's arguments filed 12/9/2025 with respect to the cited reference, Hu, have been fully considered but they are not persuasive. Applicant asserts “Hu cannot disclose or suggest a concentration for an oral composition that is for washing/rinsing and collection thereafter, as opposed to one that is meant to be ingested like Hu' s…. Thus, Hu cannot suggest an oral wash composition with a stable heavy isotope-labelled internal tracer at a concentration sufficient to produce a mass spectrometry signal that is distinguishable from background interference due to a monoisotopic form of the same internal tracer, as claimed.” [Remarks, 12/9/2025, Page 12, Paragraph 2] Applicant's argument is based on an intended use of the claimed invention. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In the instant case, vitamin C and galactose are non-toxic components that are capable of being placed in the oral cavity into the oral cavity of a human subject and subsequent collection therefrom. Therefore, Hu meets the claimed limitations. Applicant’s arguments, filed 12/9/2025, with respect to the rejection under 35 U.S.C 102(a)(1) and 102(a)(2) over Park [Remarks 12/9/2025, Page 10] and 35 U.S.C 103 over Sager [Remarks 12/9/2025, Page 13-15] have been fully considered and are persuasive. Applicant’s arguments essentially state that the references do not teach the claim limitations, as amended. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground of rejection is made in view of the references cited above Conclusion Applicant's 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 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. Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAILA A CRAIG whose telephone number is (703)756-4540. The examiner can normally be reached Monday-Friday 0800-1600. 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, Michael Hartley can be reached at 571-272-0616. 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. /K.A.C./Examiner, Art Unit 1618 /Michael G. Hartley/Supervisory Patent Examiner, Art Unit 1618
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Prosecution Timeline

May 14, 2021
Application Filed
Jul 01, 2024
Non-Final Rejection — §101, §102, §103
Oct 07, 2024
Response Filed
Dec 02, 2024
Final Rejection — §101, §102, §103
May 06, 2025
Examiner Interview Summary
May 06, 2025
Applicant Interview (Telephonic)
May 12, 2025
Request for Continued Examination
May 14, 2025
Response after Non-Final Action
Sep 03, 2025
Non-Final Rejection — §101, §102, §103
Dec 09, 2025
Response Filed
Mar 09, 2026
Final Rejection — §101, §102, §103
Apr 03, 2026
Interview Requested

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Prosecution Projections

5-6
Expected OA Rounds
33%
Grant Probability
67%
With Interview (+33.7%)
3y 5m
Median Time to Grant
High
PTA Risk
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