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 .
Priority
The instant application is the national stage entry of PCT/EP2018/068948 filed 12 July 2018. Acknowledgement is made of the Applicant’s claim of foreign priority to application DE102018204655.7 filed 27 March 2018. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e). Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Status of the Claims
Claims 1-19 are pending.
Claims 1-19 are rejected.
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.
Claims 1-19 are rejected under 35 U.S.C. 103 as being unpatentable over Bernert et al. (EP 2316407).
Bernert teaches novel dental cement systems including an aqueous dental glass ionomer composition comprising 1) a reactive particulate glass, 2) a linear or branched polymer comprising acidic groups and a polymer backbone, and 3), dispersed nanoparticles [0011-0012]. The composition can comprise the polymer in 10-80% by weight and the nanoparticles in from 0-75% by weight [0069, 0072]. The nanoparticles may have an average particle size of from 1-100 nm [0072]. The particulate reactive glass usually has an average particle size of from 0.005 to 100 μm [0041]. The composition can further comprise fillers, solvents, pigments, and other agents [0081]. Due to the use of polymers rather than monomers in glass ionomers, the composition of Bernert has no risk of acrylic monomers leaching out [0004]. The cements of Bernert can harden via crosslinking of the glass and the polymer comprising acidic groups [0003, 0097].
Regarding the nanoparticle, the dispersed nanoparticles are said to comprise “grafted linear or branched polymer chains comprising acidic groups, and having a polymer backbone” wherein the polymer chains (i.e. backbone) is obtainable by a process comprising 1) cyclopolymerizing one or more compounds of formula (I) (below) where it is important to note that none of the variables in the structure require an acidic group to be present [0012]. Compound of formula (I) can be formulated with acrylic monomers [0054].
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An example formulation comprises a ground zinc-strontium-calcium-phosphor-aluminum-fluorosilicate glass, tartaric acid, "the polyacid of example 4," wherein the polyacid of example 4 is the polymer of the structure copied below, and demineralized water [0125-0129]. The polyacid (1.8 g) and tartaric acid (0.2 g) are dissolved in 3.0 ml demineralized water, and this liquid is mixed with zinc-strontium-calcium-phosphor-aluminum-fluorosilicate glass in a powder:liquid ratio of 2:1 [0127]. Assuming that 10 g of the glass ionomer was added (to balance out the weight of 5 g of liquid solution), the example composition comprises 66.7% zinc-strontium-calcium-phosphor-aluminum-fluorosilicate glass, 12.0% polyacid, and 20.0% water.
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Regarding claims 13 and 14, Bernert discloses that the "dental composition is a multi-pack, preferably a two-pack composition," and is designed so as to avoid premature curing of the components [0101]. The multi-pack is construed to be a kit of at least two components.
Regarding claim 15, Bernert discloses that "ionomer cements are widely used in the dental field for filling of a cavity, cementing of crowns, inlays, bridges, or orthodontic bands, lining of a cavity, sealing of a root canal, core construction, and preventive sealing" [0004]. Bernert provides for using the claimed ionomer cement as a filling cement.
It would have been prima facie obvious to prepare a dental glass ionomer cement composition comprising a reactive particulate glass (acid-reactive powder), a branched polymer comprising acidic groups such as the polyacid of example 4 (polyprotic acid), water, dispersed nanoparticles (dispersed polymer particles), and other fillers as required in instant claims 1-2, 7, and 9-10. The composition can be stored as a kit, as required in claims 12-14. The base polymer of the nanoparticles is described in formula (I), which notably does not require acidic groups to be present, thus implying that less than 10% falls within the possible range of acidic monomers of the prior art. The particle sizes of instant claims 3, 8, and 16 fall within the broad ranges taught by Bernert. 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). MPEP 2144.05 (I). During formation of the dental cement, water is used to disperse the components prior to use as a hardening agent, thus addressing instant claim 4. The range of nanoparticles (polymer particles) in instant claims 5 and 17-19 fall within the prior art range of from 0-75% by weight and Bernert’s example formulation reads on instant claim 6 (see MPEP 2144.05 (I)). Bernert teaches formulating the composition by mixing it together, addressing instant claim 11, and also teaches using the composition as a dental filling cement, rendering obvious instant claim 15.
Claims 1-19 are accordingly rejected as obvious over the prior art.
Response to Arguments
Applicant's arguments filed 7 July 2025 have been fully considered but they are not persuasive. The Applicant argues, on pages 6-10, that Bernert teaches the creation of a substance with the highest possible crosslinking via chemical/physical bonding of the polymer/nanoparticles to the ionomer matrix, resulting in a compound with improved properties. The Applicant argues that a person of skill in the art would have no motivation to limit the amount of acidic monomers, as it would go directly against the teaching of Bernert.
In response, it has to be appreciated that Bernert teaches a composition comprising both component 2) a linear or branched polymer comprising acidic groups and a polymer backbone, and component 3), dispersed nanoparticles. Bernert further teaches that the nanoparticles, which are not required to comprise acidic groups, are polymerized from compounds of formula (I), which can be formulated with acrylic monomers to read on the polymer particles of the instant claims. Component 2, the linear or branched polymer, can be a polyprotic acid such as exemplified in Example 4 of Bernert. It is the polyprotic acid with acidic groups that forms crosslinking bonds with the glass powder to form the cement. Thus, modifying the additional, and optional, polymer nanoparticles wherein the base polymer comprises less than 10% by weight of acidic monomers would have been obvious and would not have gone against the teaching of Bernert.
The Applicant argues, on pages 10-11, that “while Bernert teaches one skilled in the art to prevent the formation of cracks due to a firm incorporation of the polymer into the ionomer matrix via crosslinking with little to no phase boundaries, the present disclosure aims to not prevent the inevitable formation of cracks, but to impede crack propagation.”
In response to Applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., impeding crack propagation) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
The Applicant argues, on pages 11-13, that a combination of Bernert with Shukla would not lead to the subject matter of the pending claims.
In response, Shukla has been removed from the above rejection. Arguments based on Shukla are considered moot and will not be further addressed.
Conclusion
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.
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/ANDREW S ROSENTHAL/ Primary Examiner, Art Unit 1613
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