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 .
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 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.
Previous Rejections
Applicant’s arguments, filed January 26, 2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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.
Claim Status
Claims 1-19 are pending and are examined on the merits in this prosecution.
CLAIM REJECTIONS
Failure to further limit a previous claim
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS: Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 6 is rejected under 35 U.S.C. 112(d) as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 1, upon which claim 6 depends, recites the term “effective to prevent nucleation”, while claim 6 recites the term “the formation of complexes inhibits calcium ions from forming crystallized hydroxyapatite.” The term “prevents” in claim 1 is interpreted as no nucleation is occurring, while the term “inhibits” is interpreted as reducing the amount of nucleation from the typical amount formed.
Applicant may cancel the claim, amend the claim to place the claim in proper dependent form, rewrite the claim in independent form, or present a sufficient showing that the dependent claim complies with the statutory requirements
Obviousness Rejection
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
1) Claim 1-6 and 11-18 are rejected under 35 U.S.C. 103 as being unpatentable over Gruber (WO 2020/207618 A1; citations herein are from the English language equivalent, US 2022/0202655 A1; each reference of record), in view of Benedict (US 4,661,341).
Gruber teaches a toothpaste or gel comprising remineralizing dental material, having at least one cation and at least one anion, which are configured as partner ions for forming a remineralization substance. Gruber teaches a composition containing calcium chloride and the sodium salt of acrylic acid (pg 7, [0148], Example 2). Gruber teaches the composition is preferably formulated as a gel or paste (pg 3. [0045]).
Gruber teaches an embodiment wherein the hydrous coacervate is based on polyacrylic acid and Ca2+ ions, and further teaches that, in this embodiment, phosphate may be used as partner ion in a concentration of 10 mM to 250 mM (pg 4, [0065]). It is noted that the Examiner calculates a 10 mM phosphate solution is about 0.1% in phosphate ion, meeting the definition of “essentially free” set forth in the instant specification (pg 9, [22]).
Gruber teaches the combination of a polyelectrolyte such as acrylic acid and a calcium salt form a coacervate (pg 2, [0027]-[0029]), reading on claim 2.
Regarding claims 3 and 4, Gruber teaches the gel composition is formulated for application/remineralization to dentin and enamel(pg 6, [0105]).
For claim 5, Gruber teaches a calcium compound (Example 1).
For claim 6, Gruber teaches remineralization in the instant case refers to a process involving the formation of new inorganic material forming at the remineralization site that is not crystalline hydroxyapatite (pg 2, [0012]).
For claim 11, Gruber teaches the pH of the composition is at least 5 (pg 3, [0058]), overlapping the claimed range. Because the claimed range overlaps with the range disclosed by the prior art, a prima facie case of obviousness exists.
For claim 12, as discussed above, the instant disclosure provides no definition or standard of measurement for the term “viscous”. Therefore, Gruber’s teaching of a “gel” ([0045]) is considered to meet the limitation of a “viscous gel”.
For claims 13-15, Gruber’s teaching of a gel comprising a pH of greater than 6 meets the claimed limitations.
For claim 17, Gruber teaches the inclusion of bioactive glasses in the composition to improve mechanical properties (pg 4, [0058]).
For claim 18, Gruber teaches the composition is “able to be able to be secured adhesively on the dentin in the step of use itself” (pg 2, [0024]).
Gruber does not teach the newly added limitation of prevention of nucleation of a surface calcium phosphate precipitate layer on enamel, or the presence of a surfactant in the composition.
Benedict teaches the missing elements of Gruber.
Benedict teaches polyacrylic acid (PAA) present in a dental composition inhibits or retards the formation of dental calculus (Abstract: col 2: 60-65).
For claim 2, Benedict teaches the dentifrice compositions typically contain emulsifying agents including non-soap anionic, nonionic, cationic, zwitterionic and amphoteric organic synthetic detergents (col 4: 61-69). For claim 16, Benedict teaches polyethylene glycol 600 as a nonionic surfactant.
The skilled artisan would have expected success in preventing nucleation of surface calcium phosphate utilizing the composition of Gruber, which contains polyacrylic acid, because Benedict teaches that polyacrylic acid acts as an inhibitor of the formation of dental calculus. It is noted that dental calculus is also known as “a layer of hydroxyapatite on the enamel” comprising calcium phosphate (instant Specification, pg 2, [4]).
2) Claims 7-9 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Gruber (cited above), in view of Benedict (cited above), and Kohli (US 2011/0014136 A1; of record).
The teachings of Gruber and Benedict are discussed above.
The combination of Gruber and Benedict does not teach the amount of water in the composition (claims 7 and 19) or the presence of calcium L-lactate or calcium formate as the active calcium species.
Kohli teaches the missing element of the combination of Gruber and Benedict.
Kohli teaches oral care compositions comprising an effective amount of a basic amino acid in free or salt form, together with a soluble calcium salt (Abstract). Kohli teaches the composition is in the form of a gel (pg 4, [0099]).
For claims 7 and 19, Kohli teaches water may also be present in the oral compositions in an amount of about 10% to about 30% (pg 8, [0172]), overlapping the instant range.
For claims 8 and 9, Kohli teaches the calcium salt may be selected from calcium lactate or calcium formate (pg 10, claim 3). While Kohli does not teach the “L” enantiomer of lactic acid, one of ordinary skill would be motivated to use the L-lactic acid stereoisomer since L-lactic acid is the predominant naturally-occurring isomer.
Kohli teaches soluble calcium salts may be present in an amount of from about 0.01 wt% to about 10 wt% (pg 5, [0105]), and sodium polyacrylate gels may be present (pg 8, [0165]) in amount of from 0.05% to 5% as an agent that enhances the delivery and retention of active agents to a tooth surface (pg 8, [0166]), in each instance overlapping the range recited in claims 8 and 9.
The skilled artisan would have expected success in substituting Kohli's calcium lactate or calcium formate for the calcium chloride in the composition of Gruber because Gruber teaches water soluble calcium salts increase the mineral content and ion reservoir available to the tooth surface (pg 4, [0058]) and Kohli teaches calcium formate and calcium lactate as effective, water soluble calcium species (0010]).
It is noted that inclusion of a non-ionic surfactant to the composition of Benedict, as taught by Benedict and Kohli (pg 7, [0157]), would have an expectation of success because Kohli teaches nonionic surfactants are stable within a wide pH range (pg 7, [0153]), and nonionic surfactants would not be expected to interact with the cationic calcium salt or the anionic polyacrylate salt, while potentially increasing the distribution of the active agents in the composition.
3) Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Gruber (cited above), in view of Kohli (cited above), Benedict (cited above), and Chen (CN 2021/11143027 A; equivalent of CN113749955B; for the purpose of English translation, the US equivalent US 2024/0238173 A1 is cited herein; each reference of record).
The teachings of Gruber, Benedict, and Kohli are discussed above.
The combination of Gruber, Benedict, and Kohli does not teach the amount of a bioglass in the composition.
Chen teaches the missing element of the combination of Gruber, Benedict, and Kohli.
Chen teaches a tooth gel with remineralization capability that bioactive glass in an amount of 1-35% of active ingredients (Abstract), overlapping the claimed range. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art”, a prima facie case of obviousness exists. MPEP 2144.05 (I). It is noted that Chen also teaches the remineralizing composition contains sodium polyacrylate (pg 10, claim 13).
Examiner’s Reply to Attorney Arguments dated 1/26/2026
1. Rejection of claims 1, 3-6, 11-15, and 17-18 under 35 U.S.C. § 103 over Gruber
The applicant argues that Gruber's disclosure is concerned with creating mineralizing phases, not with suppressing mineral nucleation at the enamel surface, and “ Nothing in Gruber teaches or suggests preventing nucleation of calcium phosphate at the enamel surface”. As such, the applicant argues that “Gruber does not disclose all elements of [amended] Claim 1, and the Examiner has not established a prima facie case of obviousness.” The applicant argues that there is no teaching in Gruber that prevention of nucleation is an inherent property.
The Examiner acknowledges the arguments presented, but does not consider them persuasive. The newly added limitation of nucleation-inhibiting calcium-polyanion complexes has necessitated the addition of the prior art of Benedict to the rejection. Benedict, as discussed above, teaches the inhibition of formation of calcium-phosphate complexes on the enamel surface. As such, there is no need to reject on the basis of inherency to meet the limitations of claim 1 as presently amended.
The applicant argues the rejection selectively extracts individual ingredients (e.g., calcium salts and sodium polyacrylate) while discarding the defining coacervate-based framework that governs how those ingredients interact and function in Gruber.
The Examiner acknowledges the arguments presented, but does not consider them persuasive. As discussed above, Gruber teaches compositions comprising calcium salts and polyacrylic acid (see [0065]). Regarding the teaching of a coacervate, the composition of Gruber is a toothpaste or tooth gel, with the coacervate as an ingredient. It is noted that the instant claims do not exclude a coacervate, and there is no evidence presented by the applicant that a coacervate comprising calcium salts and polyacrylic acid would prevent formation of a calcium phosphate precipitate, especially in view of the teaching of Benedict that the presence of polyacrylic acid in toothpaste is sufficient to prevent formation of the calcium phosphate precipitate.
2. Rejection of claims 2, 7-9, 16, and 19 under 35 U.S.C. § 103 over Gruber and Kohli
The applicant argues that this rejection is based on “impermissible hindsight” since “is no articulated reasoning why a person of ordinary skill in the art would have combined Gruber's coacervate-based system with Kohli's surfactants to achieve phosphate-free, nucleation-inhibiting calcium-polyanion complexes with a reasonable expectation of success.”
The applicant further argues “Kohli does not teach or suggest using a non-ionic surfactant to promote complex formation between calcium-containing remineralizing agents and poly(acrylic acid) sodium salt, nor does Kohli associate surfactants with control of calcium-polyanion interactions or suppression of mineral nucleation,” and further argues that “Neither Gruber nor Kohli teaches or suggests this role for a non-ionic surfactant, and there is no articulated reasoning why a person of ordinary skill in the art would have combined Gruber's coacervate-based system with Kohli's surfactants to achieve phosphate-free, nucleation-inhibiting calcium-polyanion complexes with a reasonable expectation of success.
The Examiner acknowledges the arguments presented, but does not consider them persuasive. Initially, the Examiner notes that the inclusion of a nonionic surfactant is taught by the newly added prior art of Benedict, a reference necessitated by applicant’s amendment. Benedict teaches the nonionic surfactant as a typical ingredient in a toothpaste composition.
3. Rejection of claim 10 under 35 U.S.C. § 103 over Gruber, Kohli, and Chen
The applicant has provided no argument regarding the correctness of this rejection. As set forth above, it is the position of the Examiner that claim 1 is properly rejected. Since applicant did not set forth additional arguments regarding the correctness of the rejection of claim 10, this rejection is considered proper, in view of the additional reference of Benedict.
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 MICHAEL P COHEN whose telephone number is (571)270-7402. The examiner can normally be reached on M-Th 8:30-5:30; F 9-4.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana Kaup, can be reached on (571) 272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL P COHEN/Primary Examiner, Art Unit 1612
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