CTFR 17/759,406 CTFR 90102 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Priority The instant claims are the national stage entry of PCT/IB2021/050678 filed 28 January 2021. Acknowledgement is made of the Applicant’s claim of domestic priority to provisional US application 62/968,104 filed 30 January 2020. Examiner's Note Applicant's amendments and arguments filed 21 April 2026 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. In the Applicant's response, filed 21 April 2026, it is noted that claims 1, 7-8 and 22-23 have been amended and claim 25 newly added. No new matter has been added. Support can be found in the claims as originally filed. Status of the Claims Claims 1, 4, 6-14, and 16-25 are pending. Claims 14 and 16-21 are withdrawn. Claims 1, 4, 6-13, and 22-25 are rejected. Claim Rejections - 35 USC § 103 07-06 AIA 15-10-15 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. 07-20-aia AIA 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. 07-23-aia AIA 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. 07-20-02-aia AIA 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. 07-21-aia AIA Claim s 1, 4, 6-13, and 22-25 are rejected under 35 U.S.C. 103 as being unpatentable over Hatanaka et a. (WO2018/092889) in view of Tosaki et al. (US 2003/0011191) in view of Farrar et al. (US 2022/0218743) in view of Ngo et al. (US 6,461,161) in view of Antler (US 2008/0052847) in view of Sipos (US 4,396,599) . Hatanaka teaches a tooth surface material that suppresses the progress of dental caries and hypersensitivity without impairing the aesthetic surface of the treatment site (abstract). The material may contain silver ions, iodide ions, and water [0008] wherein the silver ions can be derived from silver fluoride [0010]. The iodide ion can be derived from an iodide salt such as potassium iodide [0013] and can be present in from 5-60 mass% [0038]. The concentration of the silver ions is from 10-125,000 mass ppm (up to 12.5%) [0028]. The fluoride salt can be included in 0.01-5.0% of fluorine ion concentration [0036]. In one example, potassium iodide (4.55 g) is mixed with water (4.55 g) to prepare a 50 mass% solution [0058]. Next, silver fluoride (0.9 g) is added to the solution to create a tooth surface material comprising silver cations, fluoride anions, iodide anions, and water, as required in instant claim 1 [0058]. Hatanaka teaches that application of the treatment material can be done by treating the tooth surface with a microbrush that has been treated with the material [0075]. Hatanaka does not teach a package for the applicator nor does it teach using floss as the applicator. Hatanaka does not teach using the silver in 13-20 wt%. Hatanaka does not teach further including thiocyanate anion in the composition. Tosaki teaches that prophylactic measures for preventing dental caries include the use of dental floss or the use of an interdental brush [0030]. Farrar teaches that silver fluoride solutions are known to provide protection to affected teeth by killing bacteria associated with dental caries and promoting the remineralization of the collagen [0002]. Silver fluoride can also reduce tooth sensitivity [0002]. It is also disclosed that silver fluoride solutions have poor stability and the AgF tends to precipitate out upon storage [0005-0006]. To solve this issue, Farrar teaches that simply adjusting the pH to a range of 4.0-5.3 achieves solution stability [0011]. Farrar demonstrates stability up to 37.6% w/v (Table 1). Ngo teaches that a concentration of silver from 2-75 wt% is preferred for treating dental caries (abstract; col 2, lns 45-50). Antler teaches that interdental brushes can be stored in suitably sized containers for carrying in one’s pocket or purse [0004]. The container is sealed for sanitary purposes and to keep the brush clean [0005, 0008]. In addition, the sealed container can keep any moisture from leaking (and by the same rationale, prevent any moisture from entering the packaging) [0008]. Sipos teaches that the rate of development of dental enamel caries can be prevented or slowed by daily application of a composition comprising fluoride salt and zinc salt in a ratio of at least 7:1 (col 2, lns 10-22). The fluoride salt can be ammonium fluoride and the zinc salt can be zinc thiocyanate (col 2, lns 28-39). It would have been prima facie obvious to apply the composition of Hatanaka to the teeth by way of a microbrush that has been saturated with the tooth surface material in order to suppress the progress of dental caries and reduce hypersensitivity. Since the brush has to comprise the dental formulation in order to apply to the teeth, it would have been obvious to pre-saturate the brush prior to tooth application. At this point, the brush/applicator is in contact with the silver-fluoride solution. The dental treatment composition comprises silver fluoride (source of silver cations and source of fluoride anions), potassium iodide (source of iodide anions), and water as required in instant claim 1. It would have been obvious to use floss in place of the microbrush, or to use both floss and a microbrush (interdental brush) based on the teachings in the prior art that both are useful for treating dental caries. Generally, it is prima facie obvious to substitute one equivalent component or process for another, each of which is taught by the prior art to be useful for the same purpose (see MPEP 2144.06). In addition, it would have been obvious to package the application device (floss or microbrush) in a package that is sealed for sanitary reasons as well as to prevent moisture from leaking out of, or in to, the container. Furthermore, it would have been obvious to prepare the dental caries treatment composition comprising silver fluoride (source of silver cations and source of fluoride anions), potassium iodide (source of iodide anions), and water and further include zinc thiocyanate in order to further slow the rate of dental caries development. The thiocyanate anion would be used in a ratio of at least 7:1 with the fluoride (and accordingly, the silver cations) as taught by Sipos, which translates to a silver to thiocyanate ratio of 1:7 or 0.14:1. Regarding the amounts of ions, Hatanaka teaches the silver cation can be used in from 10-125,000 mass ppm, which is 0.001-12.5%, while Ngo teaches that a concentration of silver from 2-75 wt% is preferred for treating dental caries. That being said, Farrar recognized the solution instability of higher concentrations of silver and determined that adjusting the pH to a range of 4.0-5.3 achieves solution stability. Therefore, it would have been obvious to increase the amount of silver ions to 13-20 wt% so as to impart a stronger response to dental caries and further adjust the pH of the solution to counter solubility issues. Hatanaka teaches the fluoride anion can be present in from 0.01-5.0% and the iodide anions from 5-60%. Regarding the amount of water, examples include water in various amounts including 30% [0056], 45% [0058], and 93% [0055]. It would have been obvious to use water in any amount ranging from 30-93%, rendering obvious instant claims 9-10. Hatanaka teaches that the silver ions are useful as antibacterial agents and for suppressing dental caries [0023], thus it would have been obvious to adjust the amount outside the suggested range as high as 75%, as taught by Ngo. That being said and in lieu of objective evidence of unexpected results, the amount of silver ions can be viewed as a variable which achieves the recognized result of successfully suppressing dental caries. The optimum or workable range of silver ions can be accordingly characterized as routine optimization and experimentation (see MPEP 2144.05 (II)B). “[Discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” In re Boesch, 617 F.2d 272, 276 (CCPA 1980). Appellants provide no evidence of any secondary consideration such as unexpected results that would render the optimized amounts of silver ions nonobvious. As such, it would have been obvious to use silver ions in 13-20%, fluoride ions in 2%, and iodide ions in 35%, thus rendering obvious the concentration amounts of the instant claims. Regarding the molar ratio of silver to iodide ions and the molar ratio of silver to thiocyanate ions, Hatanaka teaches an example using 0.9 g of silver which is 0.008 moles of silver (0.9 g/ 107.57 g/mol = 0.008 mol) and 4.55 g of KI which is 0.027 mol of iodide (4.55 g/166 g/mol = 0.027 mol). The ratio of 0.008/0.027 is 0.296, which is less than 0.42:1. Regarding the thiocyanate ion, it is taught that zinc thiocyanate can be used in 0.14:1 ratio with ammonium fluoride. Applying the same ratio when using zinc thiocyanate with the silver fluoride of Hatanaka results in a similar 0.14:1 (silver to thiocyanate) ratio by weight. The silver in Hatanaka is used in 0.9 g and Sipos suggests that zinc salts should be used at least 7-fold greater than fluoride, thus rendering obvious an amount of about 6.3 g of zinc thiocyanate. The moles of thiocyanate are accordingly 0.108 mol (6.3 g/ 58.08 g/mol = 0.108 mol), thus a ratio of silver to thiocyanate of 0.074 (0.008/0.108) would have been obvious. A kit to treat dental caries comprising the applicator floss and/or microbrush, along with instructions, would have been obvious to prepare in order to provide the product of Hatanaka to a patient in need thereof, thus rendering obvious instant claims 1, 4, 6-13, and 22-25 . Response to Arguments 07-37 AIA Applicant's arguments filed 21 April 2026 have been fully considered but they are not persuasive. The Applicant argues, on pages 7-8 of their remarks, that the molar ratio in the prior art is about 0.436:1 which is greater than the recited molar ratio of 0.42:1. The Applicant further argues, on pages 11 of their remarks, that Sipos does not teach the silver cations ratio of less than 0.37:1 . In response, as described above, the molar ratio of silver to iodide ions is 0.296, which is less than 0.42:1. In addition, the ratio of silver to thiocyanate ions is 0.074, which is less than 0.37:1. The Applicant argues, on pages 8-9 of the remarks, that Antler’s disclosure is different from a package for containing an applicator pre-loaded with a silver-fluoride composition. The Applicant argues that Farra states that silver fluoride-containing solutions often exhibit poor stability upon storage. In response, Antler teaches that interdental brushes can be stored in suitably sized containers for carrying in one’s pocket or purse, wherein the container is sealed for sanitary purposes and to keep the brush clean, and wherein the sealed container can keep any moisture from leaking. That being said, it would have been obvious to keep the cleaning solution pre-loaded on the applicator inside the package which is air-tight and water-tight. The pre-loaded solution would remain ready to apply and since it is stored in a sealed package, it would be expected to have good stability over time (since it is not exposed to oxygen). Moreover, Farrar does identify stability as being an issue, wherein the AgF tends to precipitate out of solution, but also teaches a solution to this this issue which is the further addition of ammonia to the solution. The Applicant argues, on pages 9-10 of their remarks, that modification of Hatanaka would render it unsatisfactory for its intended purpose and that the reference states reasons not to increase dissolved silver concentration, which does not improve antibacterial performance above 12,000 ppm by mass. In response, the Applicant is erroneously pointing to narrow embodiments expressly disclosed within the prior art reference as representing the sum total of information conveyed by each. Art is art, not only for what it expressly teaches, but also for what it would reasonably suggest to the skilled artisan, including alternative or non-preferred embodiments (see MPEP § 2123). Although Hatanaka teaches that there is little benefit to amounts over 12,000 ppm by mass, the broader disclosure teaches using amounts up to 125,000 ppm. Furthermore, Ngo teaches that a concentration of silver from 2-75 wt% is preferred for treating dental caries. As such, varying and broad ranges of silver concentration would have been obvious to use in a composition for treating dental caries, wherein there would have been a reasonable expectation of success with the broad ranges. The Applicant argues, on page 11 of their remarks, that Sipos does not teach water present in an amount less than 57.1 wt% of the dental composition. In response, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller , 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Regarding the amount of water, examples in Hatanaka include water in various amounts including 30%, 45%, and 93%, therefore it would have been obvious to use water in any amount ranging from 30-93%. The Applicant argues, on page 12 of their remarks, that zinc thiocyanate is not among the thiocyanate sources recited in claim 13. In response, claim 13 provides two alternative limitations separated by “or” thus implying that only one of the two must be true at any given time. The prior art clearly teaches potassium iodide as a source of iodide ions, which renders obvious the first portion of instant claim 13 . Double Patenting 08-33 AIA 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 conflicting claims 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); 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 nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined 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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13. The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer. 08-36 AIA Claim s 1, 4, 6-13, and 22-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 1-5 and 10 of U.S. Patent No. 11,666,516 in view of Tosaki et al. (US 2003/0011191) in view of Antler (US 2008/0052847) . Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘516 claims are towards an aqueous composition comprising silver cations, thiocyanate anions, fluoride anions, and water with overlapping ranges and ratios of concentrations. Claim 10 of ‘516 requires the kit to have an applicator. Tosaki teaches that prophylactic measures for preventing dental caries include the use of dental floss or the use of an interdental brush [0030]. Antler teaches that interdental brushes can be stored in suitably sized containers for carrying in one’s pocket or purse [0004]. The container is sealed for sanitary purposes and to keep the brush clean [0005, 0008]. In addition, the sealed container can keep any moisture from leaking (and by the same rationale, prevent any moisture from entering the packaging) [0008]. Therefore, it would have been obvious to use the floss and/or microbrush of Tosaki in the package of Antler with the composition of ‘516 which requires an applicator, thus reading on instant claims 1, 4, 6-13, and 22-23 . 08-36 AIA Claim s 1, 4, 6-13, and 22-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 1-13 and 18-20 of U.S. Patent No. 11,793,734 in view of Tosaki et al. (US 2003/0011191) in view of Antler (US 2008/0052847) . Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘734 claims are towards an aqueous composition comprising silver cations, iodide anions, fluoride anions, and water with overlapping ranges and ratios of concentrations. Claim 18 of ‘734 requires the kit to have an applicator. Tosaki teaches that prophylactic measures for preventing dental caries include the use of dental floss or the use of an interdental brush [0030]. Antler teaches that interdental brushes can be stored in suitably sized containers for carrying in one’s pocket or purse [0004]. The container is sealed for sanitary purposes and to keep the brush clean [0005, 0008]. In addition, the sealed container can keep any moisture from leaking (and by the same rationale, prevent any moisture from entering the packaging) [0008]. Therefore, it would have been obvious to use the floss and/or microbrush of Tosaki in the package of Antler with the composition of ‘734 which requires an applicator, thus reading on instant claims 1, 4, 6-13, and 22-23 . 08-37 AIA Claim s 1, 4, 6-13, and 22-25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 1-14 and 20 of copending Application No. 18/469,859 in view of in view of Tosaki et al. (US 2003/0011191) in view of Antler (US 2008/0052847). The ‘859 claims are towards an aqueous composition comprising silver cations, iodide anions, fluoride anions, and water with overlapping ranges and ratios of concentrations. Claim 20 of ‘859 requires the kit to have an applicator. Tosaki teaches that prophylactic measures for preventing dental caries include the use of dental floss or the use of an interdental brush [0030]. Antler teaches that interdental brushes can be stored in suitably sized containers for carrying in one’s pocket or purse [0004]. The container is sealed for sanitary purposes and to keep the brush clean [0005, 0008]. In addition, the sealed container can keep any moisture from leaking (and by the same rationale, prevent any moisture from entering the packaging) [0008]. Therefore, it would have been obvious to use the floss and/or microbrush of Tosaki in the package of Antler with the composition of ‘859 which requires an applicator, thus reading on instant claims 1, 4, 6-13, and 22-23 . This is a provisional nonstatutory double patenting rejection. Response to Arguments 07-37 AIA Applicant's arguments filed 21 April 2026 have been fully considered but they are not persuasive. As applicants have advanced no arguments in addition to those rebutted above, this rejection stands for the reasons set forth by the examiner above . Conclusion 07-40 AIA 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 ANDREW S ROSENTHAL whose telephone number is (571)272-6276. The examiner can normally be reached M-F 8-5pm EST. 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, Brian Kwon can be reached at 571-272-0581. 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. 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If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /ANDREW S ROSENTHAL/Primary Examiner, Art Unit 1613 Application/Control Number: 17/759,406 Page 2 Art Unit: 1613 Application/Control Number: 17/759,406 Page 3 Art Unit: 1613 Application/Control Number: 17/759,406 Page 4 Art Unit: 1613 Application/Control Number: 17/759,406 Page 5 Art Unit: 1613 Application/Control Number: 17/759,406 Page 6 Art Unit: 1613 Application/Control Number: 17/759,406 Page 7 Art Unit: 1613 Application/Control Number: 17/759,406 Page 8 Art Unit: 1613 Application/Control Number: 17/759,406 Page 9 Art Unit: 1613 Application/Control Number: 17/759,406 Page 10 Art Unit: 1613 Application/Control Number: 17/759,406 Page 11 Art Unit: 1613 Application/Control Number: 17/759,406 Page 12 Art Unit: 1613 Application/Control Number: 17/759,406 Page 13 Art Unit: 1613 Application/Control Number: 17/759,406 Page 14 Art Unit: 1613 Application/Control Number: 17/759,406 Page 15 Art Unit: 1613 Application/Control Number: 17/759,406 Page 16 Art Unit: 1613 Application/Control Number: 17/759,406 Page 17 Art Unit: 1613
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