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 December 4, 2025, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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
Claim 7 is cancelled.
Claims 1-6 and 8-13 are pending and are examined on the merits in this prosecution.
CLAIM REJECTIONS
Obviousness Rejections
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) Claims 1-6, 8-9, and 13 are rejected under U.S.C. 103 as being unpatentable over Asgary (US 8,105,086; of record), in view of Agnihotri (“Nanometals in Dentistry: Applications and Toxicological Implications-a Systematic Review,” Biological Trace Element Research (2020) 197: 70-88; of record), and as evidenced by Auffin ("Towards a definition of inorganic nanoparticles from an environmental, health and safety perspective," Nature Nanotechnology Vol 4, October 2009, 634-641; of record).
Asgary teaches a dental biomaterial for sealing and/or filling tooth cavities. In the invention, the calcium salt, calcium oxide, calcium silicate, and calcium phosphate compounds are mixed with water and a bioactive phosphate and calcium enriched mixture is prepared. The composition forms hydroxyapatite during and after setting. The dental biomaterial is biocompatible, antibacterial and capable of forming an effective seal against reentrance of microorganisms into the filled cavity. The biomaterial is compatible to handle and set in an aqueous environment and to stimulate soft/hard tissue healing/generation/regeneration (Abstract).
For claim 2, Asgary teaches the powder component may comprise from 0.5 to 98 weight percent of an active/non-active additive such as Portland cement (col 22: 33-35). For claim 3, Asgary teaches the size of the powdered component is a nanosized particle or a microsized particle (col 32-33, claim 10), overlapping the claimed range.
For claim 4, Asgary teaches that calcium-silicate/calcium-aluminate cement comprising tetracalcium aluminoferrite is an alternative powder component to Portland cement (col 22: 32-38), not a component of Portland cement.
For claims 5 and 6, Asgary teaches the amount of nano-titanium oxide is from 0.5% to 25% by weight (col 34, claim 16), overlapping the range recited in claims 5 and 6, and the amount of the powder component may comprise from 0.5 to 98 weight percent of an active/non-active additive such as Portland cement (col 22: 33-35), overlapping the claimed range.
For claim 13, Asgary teaches the composition is useful as a root canal sealant or root canal filling (col 9: 16-24).
Asgary does not teach the titanium species of nanoparticulate metallic titanium in a dental composition.
Agnihotri teaches the missing element of Asgary.
Agnihotri teaches application nanoparticulate biomaterials dental compositions, including metal nanoparticles (NP) such as titanium. Agnihotri teaches enhanced antimicrobial, mechanical, and regenerative properties of these materials (Abstract; pg 70, Introduction).
Regarding the claim 8 limitation of purity of the nano titanium particles, it would have been obvious to one of ordinary skill to select a particle of 99.9%+ of titanium since the product is being used inside a living subject and impurities can lead to enhanced toxicity. As set forth in MPEP 2144.04(VII): “Purer forms of known products may be patentable, but the mere purity of a product, by itself, does not render the product nonobvious.”
Agnihotri teaches application nanoparticulate biomaterials dental compositions, including metal nanoparticles (NP) like titanium. Agnihotri teaches enhanced antimicrobial, mechanical, and regenerative properties of these materials (Abstract; pg 70, Introduction).
Regarding the claim 8 limitation of purity of the nano titanium particles, it would have been obvious to one of ordinary skill to select a particle of 99.9%+ of titanium since the product is being used inside a living subject and impurities can lead to enhanced toxicity. As set forth in MPEP 2144.04(VII): “Purer forms of known products may be patentable, but the mere purity of a product, by itself, does not render the product nonobvious.”
The claim 9 limitation of the average particle diameter of the “pure titanium is 1 nm to 300 nm” is met by Agnihotri’s teaching of titanium nano particles since nanoparticles are generally considered to be in the range of 1-100 nm (see the Auffan evidentiary reference, of record, cited above).
The skilled artisan would have expected success in substituting Agnihotri's nano titanium particles for the titanium dioxide nanoparticles in Asgary’s dental cement composition since Agnihotri teaches the nano titanium particles are effective antimicrobials in dental compositions.
2) Claims 10-12 are rejected under U.S.C. 103 as being unpatentable over Asgary (cited above), in view of Agnihotri (cited above) and Song (KR20150115183 (A), citations herein are from the machine translation provided by EPO; of record) and the Wikipedia Entry for Portland Cement (dated August 8, 2017; downloaded 5/30/2025 from the Wayback Machine at https://en.wikipedia.org/wiki/Portland_ cement; of record).
The teachings of Asgary and Agnihotri are discussed above.
Asgary teaches calcium sulfate in the composition in an amount of 5% (col 24, Example One, lines 51-55), within the claimed range of claims 11 and 12, but Asgary does not specifically disclose the species of calcium sulfate employed in the inventive composition.
Song and the Wikipedia Entry for Portland Cement teach the missing element of the combination of Asgary and Agnihotri.
Song teaches a dental cement composition that comprises 3% gypsum (CaSO4.2H2SO4), within the range claimed in claims 11 and 12. See pg 11, [0059]).
The Wikipedia Entry for Portland Cement teaches gypsum is present in Portland Cement in an amount of 2-10%. This art also teaches: “To achieve the desired setting qualities in the finished product, a quantity (2-8%, but typically 5%) of calcium sulfate (usually gypsum or anhydrite) is added to the clinker, and the mixture is finely ground” (pg 4, “Cement grinding)
The skilled artisan would have expected success in adding the claimed amount of gypsum (calcium sulfate dihydrate) to the cement taught by the combination of Asgary and Agnihotri in the Portland cement-based dental composition of Asgary because Song teaches the amount of gypsum claimed in claims 11 and 12 may be added to dental cement and the Wikipedia Entry for Portland Cement teaches the claimed amount of gypsum in Portland cement is used to achieve the desired setting qualities in the finished product.
Examiner’s Reply to the Declaration under 37 CFR §1.132 by
Inventor Yoshisugu Terauchi, dated 12/12/2025
Inventor Dr. Yoshisugu Terauchi submitted a Declaration under 37 CFR §1.132. In the Declaration, Dr. Terauchi presents experimental data disclosing the following result: “The composition without pure titanium (Sample 1) showed a compression strength of 17.59 MPa. whereas the composition containing pure titanium (Sample 2) exhibited a significantly higher value of 23.42 MPa. Such results would not have been expected.”
The Examiner acknowledges the argument and evidence presented, but does not consider them persuasive. As set forth in MPEP 716.02(b), the applicant has the burden of explaining proffered data as evidence of non-obviousness. In the present Declaration, Dr. Terauchi presents data and offers only the conclusory statement “Such results would not have been expected.” As discussed above, Agnihotri teaches enhanced mechanical properties of cements comprising titanium nanoparticles. Also supporting the fact that it was known in the art prior to the instant application that titanium particles provide enhanced strength to medical and dental implants is provided by the evidentiary art of Karakus (Journal of Orthopaedic Surgery and Research (2018) 13:94), a reference that was not cited in the above rejection. Karakus discloses experimental results that shows an improvement in compression strength of a bone cement upon addition of titanium dust (Abstract – Results):
Compression pressure measurements of the pure cement group ranged between 79.2 and 81.1 MPa; average was 80.25±0.42 MPa. Measurements of titanium-added group ranged from 79.5 to 81.2 MPa; average was 80.46 ± 0.68 MPa.
As such, the results disclosed by Dr. Terauchi were, in fact, predictable, based on the prior art of Karakus.
Examiner’s Reply to Attorney Arguments dated 12/4/2025
The applicant argues the applied references fail to disclose or suggest the claim 1 limitations of a dental composition comprising a cement component and pure titanium, and the prior art of Agnihotri discloses such a feature.
The Examiner acknowledges the arguments presented, but does not consider them persuasive. The quotation from the Agnihotri Introduction cited by the applicant states that “Besides improving their physiochemical and mechanical properties, the NPs of metals like Ag, Cu, Au, Ti, and Zn are antibacterial in nature.” The paragraph then cites examples of the metal nanoparticles: “Among them, the NPs of Ag, Au, ZrO2 , and TiO have been added to the orthodontic adhesives to increase their compressive, tensile, and shear bond strengths”.
Furthermore, the abstract states:
Nanotechnology is a vital part of health care system, including the dentistry. This branch of technology has been incorporated into various fields of dentistry ranging from diagnosis to prevention and treatment The latter involves application of numerous biomaterials that help in restoration of esthetic and functional dentition. Over the past decade, these materials were modified through the incorporation of metal nanoparticles (NP) like silver (Ag), gold (Au), titanium (Ti), zinc (Zn), copper (Cu), and zirconia (Zr). They enhanced antimicrobial, mechanical, and regenerative properties of these materials.
As interpreted by the Examiner, this passage supports the position that pure titanium metal nanoparticles enhance the antimicrobial, mechanical, and regenerative properties of dental implants (“esthetic and functional dentition”).
The applicant further argues that a dental composition containing pure titanium exhibits superior compressive strength compared to a dental composition without pure titanium particularly when used as a root canal treatment material, as supported by the attached Declaration under 37 CFR §1.132 by Inventor Yoshisugu Terauchi.
As discussed above, the Examiner acknowledges the argument and evidence presented, but is unpersuaded. In view of the teaching of Agnihotri and the previously evidentiary article by Karakus cited and discussed above, the results reported in the Declaration by Dr. Terauchi regarding the increase compression strength of dental cement doped with metallic titanium particles are neither unexpected nor surprising.
CONCLUSION
THIS ACTION IS MADE FINAL. 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, Frederick Krass can be reached on (571)272-0580. 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