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 .
Claim Status
Applicants’ amendments and arguments filed 02/05/2026 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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 1 is canceled.
Claims 2-12 are amended.
Claims 16 and 17 are newly added.
Claims 13-15 remain withdrawn.
Claims 2-12 and 16-17 are examined on the merits.
Terminal Disclaimer
The terminal disclaimer filed on 02/05/2026 disclaiming the terminal portion of any patent granted on this application has been reviewed and is accepted. The terminal disclaimer has been recorded.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 12/01/2026 are being considered by the examiner. The submission is in compliance with the provisions of 37 CFR 1.97.
Claim Interpretations
Claims 4 and 10, recite the term “optionally”, which is interpreted by the examiner to mean any component following these terms in not a required claim limitation.
Claim 4 recites the added limitation of “i) 0.01 to 5 wt% of one or more additives” which is interpreted by the examiner to include anything in addition to the other required components, such as an antimicrobial agent or solvent.
Claims 2, 4, and 10, recite multiple components at a concentration ranges which include 0% (i.e. claim 4, h) water). Examiner notes that this range encompasses 0% which is the absence of the component, therefore, any component including a concentration of 0% is not deemed a requirement of the claim.
In regards to claims 11 and 12, as to the limitation of 'wherein the radical polymerizable composition is used' it is noted that the instant claims are composition claims and future intended use is not given patentable weight. Thus any composition comprising the limitations of instant claim 1 from which these claims depend, will meet this limitation.
New Rejections Necessitated by Claim Amendments
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 5-7, 9, and 16-17 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 5-7, 9, and 16-17 recite the limitation of “wherein the at least one radically polymerizable monomer”. In the instant case, the claims listed claims now depend upon claim 4 which fails to make mention of “at least one radically polymerizable monomer”, but instead says a “A radically polymerizable composition” and then states the composition comprises multiple monomers. Thus, it is unclear if the “radically polymerizable monomer” of the claims are further defining a specific monomer found within the composition of claim 4 or if the claims are added an additional monomer, thus rendering the claim indefinite.
For the purpose of moving prosecution forward, the Examiner broadly interprets the “radically polymerizable monomer” to mean any monomer listed in the composition of claim 4.
Claim 10 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 10 recites “The composition according to claim 4, in the form of two spatially separated components that are to be mixed prior to use, comprising a catalyst paste and a base paste” then lists the components of claim 4 in different sub-compositions (i.e. catalyst paste, c) 2 to 30% of at least one monomer containing an acid group). It is unclear if the catalyst paste or base paste are further added to the composition of claim 4 or if claim 10 is utilizing claim 4 to create a two different compositions that are used together or alone. Further, this is unclear as to which components of instant claim 4 are in which mixture of claim 10. For example, is the glass filler the same in both the base and the catalyst or are they different or additional components. This is further unclear as to the concentration total of each component as a whole. For instance, is the concentration of glass filler just the 10 to 80% of the instant claim 4 or is it a combination of the 10 to 80% in the base paste and the 10 to 80% in the catalyst thus teaching up to 100% filler. Furthermore, Claim 10, which is dependent upon claim 1, recites a “base paste” composition which fails to include the include the polyfunctional monomer with acid group (UDMA) of claim 1. In summary, the limitations of the instant claim 10 remain unclear and indefinite.
Due to the vastly unclear nature of the claim, claim 10 will not be further evaluated.
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.
Claim 2-9, 11-12 and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Salz et al. (US9339443B2, published 05/17/2016, hereafter Salz) in view of Peez et al. (US20160310368A1, published 10/27/2016, hereafter Peez).
Salz teaches a dental restorative material based on an antimicrobially active compound (title). Salz claims the dental composition comprises (a) a filler (b) at least one radically polymerizable monomer and (c) at least one initiator for the radical polymerization (claim 1; according to the limitations of the instant claim 4). Salz teaches a catalyst paste sample composition comprising (a) about 3 to 8% acidic mono, preferably methacyloyloxydecyl dihydrogen phosphate (MDP); (b) about 25 to about 37% radically polymerizable monomer, preferably urethane dimethacrylate (UDMA); (d) about 0.5 to about 2.5% of a photoinitiator system; and (e) about 20 to about 70% filler, preferably about 5 to about 25 wt.-% X-ray opaque filler, in particular ytterbium trifluoride, about 2 to about 5.5 wt.-% SiO2 particles, about 10 to about 45 wt.-% splinter polymerisate and about 5 to about 45 wt.-% finely-ground glass filler, in particular barium glass or strontium glass filler (column 22, lines 14-30; according to the limitations of the instant claims 4, 7, and 16-17). Furthermore, Salz teaches that adhesive and primer compositions preferably have a composition comprising a) about 0.05 wt% to about 10 wt% of compound of Formula (I) (defined as an antimicrobial agent in claim 1); b) about 10 to about 20% cross-linking monomer, in particular glycerol dimethacrylate (GDMA) or triethylene glycol dimethacrylate (TEGDMA); c) about 30 to about 50 wt% hydrophilic monomer, preferably 2-hydroxyethyl methacrylate (HEMA); d) about 20 to about 30 wt % acidic monomer, preferably methacryloyloxydecyl dihydrogen phosphate (MDP); e) about 0.5 to about 2.5% initiator; f) about 5 to about 20% organic solvent, preferably ethanol (column 21, lines 44-61; in regards to the limitations of the instant claims 4, 7, and 16-17). Salz provides a sample composition comprising from about 5 to about 55% water (column 23, lines 19-20; according to the claim limitations of the instant claim 4). Salz teaches a self-adhesive composition and/or self-conditioning fixing cements preferably having the following composition: Base paste: (a) about 0.05 to about 20 wt.% Formula I (active), (b) about 25 to about 40 wt% radically polymerizable monomer, preferably urethane dimethyacrylate,
Salz fails to teach the glass filler is acid washed with hydrochloric acid as in instant claims 3-4 and 10. Furthermore, Salz fails to the teach the glass filler to have one of the compositions of the instant claim 2.
Peez teaches a dental composition for curing with a glass ionomer cement (title and [0001]). Peez teaches the composition comprises acid-reactive inorganic filler, non acid-reactive filler, and polyacid (claim 1; according to the claim limitations of the instant claim 4). Peez teaches the polyacid to be selected from homopolymers and copolymers of acrylic acid, methacrylic acid, itaconic acid, maleic acid, glutaconic acid, aconitic acid, citraconic acid, mesaconic acid, fumaric acid, tiglic acid, copolymers of maleic acid and ethylene and mixtures thereof (claim 5; according to the claim limitations of the instant claim 4). Peez further claims the composition comprising an initiator suitable to cure polymerizable components or monomers (claim 2; according to the claim limitations of the instant claim 4). Peez teaches the filler can be radiopaque or radiolucent ([0118]; according to the claim limitations of the instant claim 4). Furthermore, Peez teaches the powder typically comprises a acid reactive filler to be a fluoroalumino silicate glass (claims 1 and 3 and [0002]; according to the claim limitations of the instant claim 4). Peez claims the acid-reactive inorganic filler to be selected from a group to include basic metal oxides, metal hydroxides, aluminosilicate glasses, fluoroaluminosilicate glasses, glasses having a Si/Al ratio by wt.-% of below 1.5 and mixtures thereof (claim 3; according to the claim limitations of the instant claim 2). Peez teaches the preferred acid-reactive glass is fluoroaluminosilicate (FAS)and that suitable acid-reactive filler include metal oxides, metal hydroxides, acid-reactive glasses. Typical metal oxides include barium oxide, strontium oxide, calcium oxide, magnesium oxide, zinc oxide. Typical metal hydroxides include calcium hydroxide, magnesium hydroxide, strontium hydroxide and mixtures thereof ([0106-0107]; according to the claim limitations of the instant claims 2 and 4). Furthermore, Peez teaches examples of suitable non acid-reactive fillers are naturally occurring or synthetic materials including, but not limited to: quartz; nitrides (e.g., silicon nitride); glasses derived from, e.g., Zr, Sr, Ce, Sb, Sn, Ba, Zn, and Al; feldspar; borosilicate glass; kaolin; talc; cation reduced aluminosilicate glasses (sometimes also referred to as cation depleted glasses), silica particles ([0125]); according to the claim limitations of the instant claim 2). Peez claims the acid-reactive inorganic filler to be fluoroalumina silicate glass at a concentration of about 10 to about 95% and the non acid-reactive inorganic filler to be selected from a group to include from quartz, nitrides, silica, kaolin, feldspar, borosilicate glass, strontium oxide based glass, barium oxide based glass, cation reduced aluminosilicate glasses, and mixtures thereof at a concentration of about 5 to about 30% (claims 4 and 10; according to the claim limitations of the instant claim 2). Table 1 of Salz provides a composition for the glass powder with the following: Si: 10-15 wt.%; Al: 10-15 wt.%; Sr: 23-26.5 wt.%; Na: 2.0-4.0 wt.%; F: 11.0-14.5 wt.%; P: 2-3.5 wt.%; La: 4.5-7 wt.%; O: 26-30 wt.% ([0228]; according to the claim limitations of the instant claim 2). Peez further teaches the glass powder of Table 1 is prepared by washing the glass particles in hydrochloric acid (1 mol/l) ([0228]; according to the claim limitations of the instant claims 3-4). Table 1 of Peez further provides a composition for the silicate glass non acid-reactive components: : Al2O3: 15 wt.%: B2O3: 15 wt.%; SrO: 20 wt.% ([0228]; according to the claim limitations of the instant claim 2). Peez teaches increasing the polycarboxylic acid in a glass filler increased the flexural strength of the composition, however this resulted in the mixture becoming too viscous ([0003]; according to the claim limitations of the instant claim 4). Peez teaches that cation reduced aluminosilicate glasses react much slower upon contact with polyacrylic acid in water and that these can be achieved by surface treatments such as acid washing ([0055-0058]; according to the claim limitations of the instant claims 3-4). Furthermore, Peez teaches these acid washed filler to have a higher shear rate (fig. 1 and [0055]; according to the claim limitations of the instant claim 4). Lastly, Peez teaches that water is present in the amounts of about 5 to about 16% ([0149]; according to the claim limitations of the instant claim 4).
It would be obvious to one skilled in the art before the effective filing date of the claimed invention would claim a dental radical polymerizable composition comprising UDMA, MDP, a glass filler, and a initiator as outlined by Salz with the ready for improvement with the known technique of acid washing the glass filler with hydrochloric acid and utilizing silicon aluminum filler compositions with the desired ingredients at the desired concentrations to a polymerizable dental composition as outlined by Peez. Adding and adjusting the forementioned components to a radical polymerizable composition comprising UDMA, MDP, and a polymerizable initiator as claimed by instant claims 2-9, 11-12, and 16-17 would yield predictable results, such as making the glass filler less reactive to carboxylic acid solutions or making the glass filler have a higher shear rate, thus making them of obviousness as modification of a known product with a known technique is within the purview of the skilled artisan. Furthermore, in regards to claim 4, it would be obvious to one of ordinary skill in the art would know how to optimize the ranges of Salz, as the MPEP 2144.05 states “Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.”
Response to Applicant’s Arguments
Applicant’s arguments filed on 02/05/2026 have been considered.
In regards to the 35 USC § 103 rejection over Salz in view of Peez, Applicant first argues that column 20 of Salz does not teach a mixture of polyfunctional and monofunctional monomers, let alone the claimed amounts. Next Applicant argues that the filling material found in column 21, lines 4-21 of Salz does not contain an acidic polyfunctional monomer and the coating material of column 21, lines 25-43, do not contain acidic monomer. Further, Applicant argues that the self-adhesive and self-conditioning cements of column 21, line 62 to column 22 line 30 of Salz do not contain monofunctional monomers. Additionally, Applicant argues that Salz alone does not teach the acid washed glass filler and that one skilled in the art would not use the glass filler of Peez with the materials of Salz. Specifically Applicant argues that Peez is directed towards a glass ionomer cement and not radically polymerizable materials as disclosed by Salz. Applicant furthers this argument by claiming Peez is preferably free of polymerizable components with methacrylate group referencing one paragraph, [0036] of Peez.
In regards to Applicant’s arguments against specific embodiments of Salz, specifically Salz alone, it is first noted that 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). Further, it is noted the rejection of record is a 35 USC § 103 rejection in which a reference is analyzed using its broadest teachings. MPEP 2123 [R-5]. “[W]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious”. KSR v. Teleflex, 127 S,Ct. 1727, 1740 (2007)(quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious”, the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR v. Teleflex, 127 S.Ct. 1727, 1741 (2007). The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742. A person of ordinary skill in the art who is not an automaton is capable of producing the composition of the instant claims with predictable results. As outlined in the 35 USC § 103 rejection over Salz in view of Peez above, Salz teaches that adhesive and primer compositions preferably have a composition comprising a) about 0.05 wt% to about 10 wt% of compound of Formula (I) (defined as an antimicrobial agent in claim 1); b) about 10 to about 20% cross-linking monomer, in particular glycerol dimethacrylate (GDMA) (a polyfunctional monomer) or triethylene glycol dimethacrylate (TEGDMA) (a polyfunctional monomer); c) about 30 to about 50 wt% hydrophilic monomer, preferably 2-hydroxyethyl methacrylate (HEMA); d) about 20 to about 30 wt % acidic monomer, preferably methacryloyloxydecyl dihydrogen phosphate (MDP) (a monofunctional monomer); e) about 0.5 to about 2.5% initiator; f) about 5 to about 20% organic solvent, preferably ethanol (column 21, lines 44-61; Therefore, Applicant’s argument against one example or table in Salz alone is an improper rebuttal to obviousness since obviousness is not limited to ‘preferred embodiments’, but instead the reference as a whole. It is also noted that Applicant’s instant claims makes no mention of a “coating” or “filling” as Applicant is arguing.
In regards to Applicant’s argument that one would not combine Salz and Peez because Peez is directed towards ionomer cements. It is noted that Peez teaches ““polymerizable components” is any component which can be cured or solidified e.g. by heating to cause polymerization, chemical crosslinking, radiation-induced polymerization or crosslinking by using a redox initiator. A polymerizable component may contain only one, two, three or more polymerizable groups ([0035]). Further, it is noted that both Salz and Peez are directed towards restorative dental curable materials containing FAS glass, thus they are considered to be within the same field. Further, in regards to Applicant’s claim that Salz teaches away from the use of methacrylate groups, it is again noted that this is a 35 USC § 103 rejection that is taken as a whole and a reference to a single example is an improper rebuttal. To add to this point, Salz further teaches typical examples of polymerizable groups include unsaturated carbon groups, such as a vinyl group being present i.a. in a (methyl)acrylate group ([0035]). Thus, in summary the teachings of both Salz and Peez are not only used in the same field of study, but also contain multiple of the same ingredients, thus making them obvious to combine as they are both known in the art.
In summary, Applicant’s arguments are not found persuasive. The rejections have been maintained and updated for claim amendments and new claims.
In regards to the Non-Statutory Double Patenting rejections, Applicant’s approved terminal disclaimer overcomes the rejections of record. Thus, the previous rejections are withdrawn.
Conclusion
No claims allowed.
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.
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/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
/A.N.I./ Examiner, Art Unit 1611
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