DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant's election with traverse of Group I, claims 1, 3-9, 12, 14-17, 24, 25, reading thereon in the reply filed on 4/22/2025 remains acknowledged.
Applicant's election with traverse of:
zinc citrate as a zinc carboxylate;
ammonia as amine containing ligand (now recited in amended claim 1); and
ammonium fluoride as source of fluoride anion,
in the reply filed on 4/22/2025 remains acknowledged.
Claims 9, 27 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 4/22/2025.
Claims 18-20, 22-23 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 4/22/2025.
Claim Rejections - 35 USC § 103
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 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, 3-7, 9, 12, 14, 17, 24-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Willey et al. (US 2018/0221210 A1; 2018), in view of Jaracz et al. (WO 2016/064412 A1; 2016).
Willey teaches compositions that comprise, inter alia, a gasotransmitter, and treating a variety of disease states (abstract), [0011]. Gasotransmitters is applied to, for example, inter alia, Applicant elected ammonia [0012]. Examiner notes that alternative compound is a soluble nitrite salt [0013]; the sodium nitrite in Table 1 D uses 5.0%, rendering this concentration obvious for the alternative ammonia, rendering the range of claim 14 prima facie obvious.
See MPEP 2144.05(I), second paragraph: Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985)
Therapeutic systems for bringing one or more gastransmitters into therapeutic contact at a tissue site; such systems include dressings, bandages and the like [0018].
Compositions include Oral Care Compositions; the electrochemical composition may be an oral care composition to be topically applied to the mucosal tissue of the oral cavity, to the gingival tissue of the oral cavity, to the surface of the teeth or any combination (construed as a dental article configured to access an interproximal gap) [0090].
Actives that may be used in place of or in combination with the pyrophosphate salt are materials that include Applicant elected zinc citrate trihydrate [0098] (reading on claims 6 & 7). Pyrophosphate at from about 0.5 to about 5% of the pyrophosphate by weight [0096] renders prima facie obvious the range starting at 5% of the alternative zinc citrate trihydrate required by claim 15.
See MPEP 2144.05 (I): In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (The prior art taught carbon monoxide concentrations of "about 1-5%" while the claim was limited to "more than 5%." The court held that "about 1-5%" allowed for concentrations slightly above 5% thus the ranges overlapped.);
Regarding the obvious 5% of zinc citrate, this percentage corresponds to about 0.765 mol of zinc (atomic weight 65.38 g/mol); regarding the obvious 5% of ammonia (molecular weight 17.031 g/mol), this percentage corresponds to about 2.936 mol of ammonia (assuming densities about 1.00 mg/mL); the ratio of zinc:ammonia is 0.261, or 1:3.84, construed to be within about 1:3, reading on the claim 17 range, or alternatively, obvious as close to the range recited by claim 17.
Regarding the source of fluoride anion, Application of fluoride ions to dental enamel serves to protect teeth against decay; examples include Applicant elected ammonium fluoride [0100] (reading on claim 12). Examiner notes that application is construed to be a teaching of an applicator; additional applicators taught include carrier materials, effective to contain and preserve the gasotransmitter-generation composition, such as, inter alia, gauze, foam, sponge, which can be positioned at a therapeutic site so as to bring to bear a therapeutically effective amount and concentration of the gasotransmitter [0143]. Examiner notes that gauze, foam and sponge are construed to be equivalent to the swab applicator embodiment of claim 3, or alternatively, rendering a swab as obvious over these closely related carrier materials. Pre-saturation of these applicators (claim 4) is construed to be taught by the therapeutically effective amount and concentration of the gasotransmitter composition taught
Regarding the water, in aqueous composition, the composition may comprise from 0.1% to 99%, by weight of the composition of water [0039]. This range encompasses the claimed range of claim 16, rendering the claimed range prima facie obvious.
See MPEP 2144.05 (I): In the case where the claimed ranges "… lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding the pH, Willey teaches pH values that include about 8.0 and specific values of pH 8.0, reading on and rendering obvious the pH of at least 8, required by claim 1.
Regarding the homogeneous solution at the recited temperature range, the obvious combination of the same components as Applicant elected is presumed to have the same properties as claimed, absent evidence to the contrary.
It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to "prove that subject matter shown to be in the prior art does not possess characteristic relied on" (205 USPQ 594, second column, first full paragraph).
Regarding the recited package, packaging is taught at [0123]; materials include polyethylene terephthalate, known to hold (impermeable) to aqueous solutions, which is also construed to be impermeable to water vapor.
Willey teaches each of the elected components, and renders obvious amounts and the ratio required by claims 14-17. The components require selection from different parts of this document, not considered taught together sufficient for anticipation. However, combination of each of these elements required by the instant claims would have been prima facie obvious, selected for the reasons taught by Willey. While cases have been set forth rendering amounts and the ratio obvious, starting with this amounts it would alternatively have been obvious to optimize amounts of each of the elected components and the pH, rendering each concentration and the ratio prima facie obvious as a result of routine optimization to determine workable concentrations.
Regarding claim 24, instructions are taught [0021]; it would have been obvious to instruct a user to contact the aqueous solution containing zinc fluoride to a tooth/teeth, surface, as part of the kit taught, as topical application to the surface of the teeth is taught [0090].
Regarding claim 25, a methacylate mixture is taught for the purpose of viscosity increasing agent [0058], which would have been obvious to include; the recited photo-curable property is construed to be characteristic of the same material.
It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to "prove that subject matter shown to be in the prior art does not possess characteristic relied on" (205 USPQ 594, second column, first full paragraph).
Regarding the concentration of zinc citrate (a zinc carboxylate), the amount of zinc citrate and fluoride of amended claim 1 are not taught by Willey. The skilled artisan would have found it obvious to evaluate other relevant prior art for amounts of these components. Such a reference is Jaracz:
Jaracz teaches preparation of zinc citrate and of Zinc Citrate-Containing oral care compositions. A procedure employs a suspension of zinc oxide, to which citric acid is added, followed by agitating the suspension until a clear solution is obtained, and additional oral care ingredients are then added to the solution [0012].
Table 5 documents zinc citrate may be present in an amount ranging from 0.1 to 10 weight % [0077]. This overlaps with the claimed range of 5-15 wt %, rendering the claimed zinc citrate concentration obvious.
Regarding the concentration of fluoride, fluoride ions may be added as the additional oral care ingredient, in amounts up to 5% or up to 10%, encompassing a range of at least 4 wt %, reading on claim 4 (Applicant elected ammonium fluoride is preferred by Willey), which would have been an obvious source of fluoride ions in the obvious amounts taught by Jaracz.
Regarding water in the amended range, water is taught by Willey in the range from 0.1 to 99% [0039], rendering obvious the claimed subrange from within the prior art range.
A solution is taught by Jaracz, and would have reasonably been expected for the concentrations of the claims, when following the procedure taught by Jaracz.
Applicant argues that Willey does not teach zince citrate amounts higher than 5%. But Jaracz does. The concentration range higher is taught by Jaracz. And higher amounts would also have been obvious as a result of routine optimization, starting with ranges taught by Jaracz. The procedure of Jaracz appears to overcome issues cited by applicant. The obviousness of ammonia is based on this component taught by Wiley
Double Patenting
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.
Claims 1, 3-9, 12, 14-17, 24-25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-14 & 18 of copending Application No. 17/789,430 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are drawn to a dental article comprising at least one applicator and zinc-fluoride composition and a package, whereas the copending claims at drawn to a dental composition containing the same composition as the instant zinc-fluoride composition, when the copending amine-containing ligand corresponds to copending claim 8 embodiment of ammonia. Thus, the instant claims anticipate the copending claims, rendering the claims obvious over each other. Additionally, the applicator of swab in the instant claims is obvious from the application step of copending claim 17
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Examiner notes the Terminal Disclaimer has been disapproved, and suggests resubmitting the td.
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 TIMOTHY P THOMAS whose telephone number is (571)272-8994. The examiner can normally be reached M-Th 6:30-5:00.
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, Ali Soroush can be reached at (571)272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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TIMOTHY P. THOMAS
Primary Examiner
Art Unit 1614
/TIMOTHY P THOMAS/Primary Examiner, Art Unit 1614