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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/14/2025 has been considered by the examiner.
Response to Amendment
No claim has been amended responsive to the Office Action filed 10/07/2025. Claims 1-15 and 17-20 are pending in this application.
Response to Arguments
Applicant’s arguments, see Remarks and Declaration under C.F.R. § 1.132 filed 02/02/2026, with respect to claim 1 have been fully considered but are not persuasive.
Applicant argues that “That is, Comparative Example 3 corresponds to the heating profile disclosed in Hauptmann. As shown in Table B and evidenced in the attached declaration, following the protocol equivalently described in Hauptmann, a worse flexural strength, i.e.,768 MPa, is achieved relative to the claimed invention. which achieves 793 MPa. Moreover, as shown in Table C and evidenced in the attached declaration, Hauptmann's protocol cannot maintain the color numbers (ΔE*ab) as well as the claimed method.” (Remarks, page 3)
These arguments are found to be unpersuasive because:
Even though in the Comparative Example 3 in Declaration under C.F.R. § 1.132 the temperature increase rate (HR3) in the third temperature increase (H3) is same as the temperature increase rate (HR2) in the second temperature increase (H2), the temperature increase rate (HR1) in the first temperature increase (H1) is not within the range of the heating rate of the first heat-treating segment described in Hauptmann (“at least 180 to 240° C./min”, Pa [0072]), thus the Comparative Example 3 does not correspond to the heating profile disclosed in Hauptmann. Furthermore, Hauptmann teaches that the sintered dental zirconia article or restoration obtained by the process described in Hauptmann can typically be characterized by biaxial flexural strength: 800 to 1,400 MPa, determined according to ISO 6872:2015 and being tooth coloured (Pa [0217], [0219] and [0224]). Therefore, unlike Applicant’s allegation, the comparison between the Comparative Example 3 and the Example 3 does not show any critical temperature increases that produce unexpected results.
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 1-7 and 9-20 are rejected under 35 U.S.C. 103 as being unpatentable over Hauptmann et al. (US 2021/0093517). Additional supporting evidence provided herewith by Belov et al. (US 2003/0113254).
With respect to claim 1, Hauptmann teaches a method for producing a zirconia sintered body (“a process of producing a dental zirconia restoration”, Pa [0018]), the method comprising:
firing a zirconia molded body or a zirconia pre-sintered body (“The process of producing the dental article comprises the step of firing a porous dental zirconia article until the porous dental article is sintered.”, Pa [0068]), comprising a temperature increase stage (“the first heat-treating segment” and “the second heat-treating segment”) and a temperature maintaining stage (“the third heat-treating segment”), the temperature increase stage comprising a first temperature increase (H1) (“The firing process comprises one or more heat-treating segments.”, Pa [0070]) and a second heat-treating segment (Pa [0079]),
wherein, when a temperature increase rate in the first temperature increase (H1) is defined as HR1, HR1=50 to 500° C./min, HR1>HR2 (“A first segment of heat-treating is done with a heating rate of … at least 180 to 240° C./min”, Pa [0072]; “the heating rate of the second heat-treating segment is lower than the heating rate of the first heat-treating segment”, Pa [0081]),
wherein starting temperatures in the first and second temperature increases are room temperature to 300° C. in H1 (“With such heating rates a temperature increase of at least 180 to 240° C./min can be obtained.”, Pa [0072]; “the temperature where the sintering of the dental porous zirconia article starts can be reached within a time frame of 4 to 8 min.”, Pa [0073]; “temperature of the first heat-treating segment is typically in the range of 1,200 to 1,400° C.”, Pa [0076]; it provides that the stating temperature is between 0° C and 680° C. In the case where claimed ranges “overlap or lie inside ranges disclosed by prior art” a prima facie case of obviousness exists. (See MPEP 2144.05 (I)), and 900 to 1250° C. in H2 (“the first heat-treating segment is typically followed by a second heat-treating segment back-to-back (i.e. without interruption)”, Pa [0079]; “temperature of the first heat-treating segment is typically in the range of 1,200 to 1,400° C”, Pa [0076]; In the case where claimed ranges “overlap or lie inside ranges disclosed by prior art” a prima facie case of obviousness exists. (See MPEP 2144.05 (I)).
reaching temperatures in the first and third temperature increases are 900 to 1250° C. in H1 (“temperature of the first heat-treating segment is typically in the range of 1,200 to 1,400° C”, Pa [0076]; In the case where claimed ranges “overlap or lie inside ranges disclosed by prior art” a prima facie case of obviousness exists. (See MPEP 2144.05 (I)), and 1400 to 1650° C. in H3 (“the sintering temperature for dental zirconia materials described in the present text is typically at least 1,500° C. and not more than 1,650° C”, Pa [0084]).
Hauptmann further teaches that the first heat-treating segment is typically followed by a second heat-treating segment back-to-back (i.e. without interruption) (Pa [0079]), the heating rate of the second heat-treating segment is lower than the heating rate of the first heat-treating segment (Pa [0081]), heating rates which can be used are typically 2K/sec (or less) or 1K/sec (or less) (which provides the range of 120° C./min or less) (Pa [0082]), the second heat-treating segment is typically done until the sintering temperature of the dental zirconia article is reached (Pa [0083]), the sintering temperature for dental zirconia materials described in the present text is typically at least 1,500° C. and not more than 1,650° C. (Pa [0084]), but does not explicitly teach that the firing step comprises at least three temperature increase steps including the first temperature increase step (H1), a second temperature increase step (H2), and a third temperature increase step (H3), when a temperature increase rate in the second temperature increase step (H2) is defined as HR2, and a temperature increase rate in the third temperature increase step (H3) is defined as HR3, HR2=11 to 300° C./min, HR3=10 to 299° C./min, HR2/HR3>1, starting temperature is 1300 to 1550° C. in H3, and reaching temperature is 1300 to 1550° C. in H2.
However, Hauptmann further teaches that the duration of the second heat-treating segment is typically dependent from the size and dimensions of the porous dental zirconia article to be sintered (Pa [0085]) and the duration of the second heat-treating segment is typically in the range of 1 to 15 min or 2 to 14 min or 5 to 12 min (Pa [0086]), and the second heat-treating segment is typically followed by a third heat-treating segment back-to-back (Pa [0088]), and during the third heat-treating segment the temperature is typically not further increased but maintained for a so-called dwell time (Pa [0089]). Thus, one would have found it obvious to select the optimum the heating rates of the second heat-treating segment within the range of 120° C./min or less by routine experimentation in order to adjust the duration time of the second heat-treating segment based on the size and dimensions of the porous dental zirconia article to be sintered, since it has been held that “[W]here 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.” See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Furthermore, since the third heat-treating segment where the temperature is maintained follows the second heat-treating segment, one would have found it obvious to reduce the heating rate later the second heat-treating segment in order to stop increasing the temperature at the end of the second heat-treating segment and go on to the third heat-treating segment. Regarding the ranges of heating rates and temperatures, in the case where claimed ranges “overlap or lie inside ranges disclosed by prior art” a prima facie case of obviousness exists. (See MPEP 2144.05 (I)).
With respect to claim 2, Hauptmann as applied to claim 1 above further teaches that HR2 is 13 to 280° C./min (“heating rates which can be used are typically 2K/sec (or less) or 1K/sec (or less)”, Pa [0082] which provides the range of 120° C./min or less). In the case where claimed ranges “overlap or lie inside ranges disclosed by prior art” a prima facie case of obviousness exists. (See MPEP 2144.05 (I)).
With respect to claim 3, Hauptmann as applied to claim 1 above further teaches that HR3 is 13 to 250° C./min (“heating rates which can be used are typically 2K/sec (or less) or 1K/sec (or less)”, Pa [0082] which provides the range of 120° C./min or less). In the case where claimed ranges “overlap or lie inside ranges disclosed by prior art” a prima facie case of obviousness exists. (See MPEP 2144.05 (I)).
With respect to claim 4, as recites above, since the third heat-treating segment where the temperature is maintained follows the second heat-treating segment, one would have found it obvious to reduce the heating rate later the second heat-treating segment in order to stop increasing the temperature at the end of the second heat-treating segment and go on to the third heat-treating segment. Furthermore, one would have found it obvious to select the reduced heating rate later the second heat-treating segment by routine experimentation in order to stop increasing the temperature at the end of the second heat-treating segment and go on to the third heat-treating segment, since it has been held that “[W]here 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.” See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
With respect to claim 5, Hauptmann as applied to claim 1 above further teaches that a maximum firing temperature in the first, second, and third temperature increases is 1400 to 1650° C. (“the final sintering temperature is typically within a range of 1,500 to 1,650° C.”, Pa [0094]) and a duration in which the maximum firing temperature is maintained is 15 minutes or less (“A suitable dwell time is typically 8 min to 1 min or 5 min to 1 min or 3 min to 1 min.”, Pa [0089]).
With respect to claim 6, Hauptmann as applied to claim 1 above further teaches decreasing a temperature from a maximum firing temperature in the first, second, and third temperature increases to 1100° C. at a temperature decrease rate of 10° C./min or more (“The third heat-treating segment is typically followed by a cooling-down segment back-to-back. The cooling-down rate is typically at least 3K/sec or at least 4K/sec. During the cooling-down segment, the sintered dental zirconia article is cooled down to about 1,000° C.”, (Pa [0096]-[0098]). In the case where claimed ranges “overlap or lie inside ranges disclosed by prior art” a prima facie case of obviousness exists. (See MPEP 2144.05 (I)).
With respect to claim 7, Hauptmann as applied to claim 1 above further teaches that a total firing time from a start of a temperature increase in the first temperature increase (H1) to an end of a duration in which a maximum firing temperature is maintained is 50 minutes or less in the firing (“within a time frame of 4 to 8 min”, Pa [0073]; “The duration of the second heat-treating segment is typically in the range of 1 to 15 min”, Pa [0086]; “A suitable dwell time is typically 8 min to 1 min”, Pa [0089]).
With respect to claims 9 and 11, Hauptmann as applied to claim 1 above further teaches that the zirconia molded body or the zirconia pre-sintered body comprises a stabilizer present in a range of from 2 to 8 mol %, based on a total number of moles present in the zirconia molded body or the zirconia pre-sintered body (“the porous dental zirconia article…being composed of a zirconia material containing about 4 mol % yttria”, Pa [0022]).
With respect to claim 10, Hauptmann as applied to claim 1 above does not explicitly mention that in the zirconia molded body or the zirconia pre-sintered body, at least a portion of the stabilizer is not dissolved in zirconia as a solid solution. However, Hauptmann further teaches that crystal structures include tetragonal, monoclinic, cubic zirconia and mixtures thereof (Pa [0034]), and additional supporting evidence (Belov et al., US 2003/0113254) teaches that the critical characteristic of this YSZ powder responsible for performance at high temperatures is homogeneity of the yttria stabilizer distribution throughout the zirconia crystal lattice, and insufficient homogeneity reveals itself as a presence of deleterious monoclinic phase or non-stabilized zirconia (Pa [0002]), the stabilized zirconia can have no monoclinic phase in it, i.e. having stabilizer ions distributed with an atomic scale uniformity (Pa [0004]), and the conventional methods make form the product including some monoclinic phase by volume even though they pursue high chemical homogeneity of the product (Pa [0005], [0007] and [0024]). Thus, one having skill in the art would have considered that at least a portion of the stabilizer is not dissolved in zirconia as a solid solution in the zirconia molded body or the zirconia pre-sintered body because of no 100% fully homogeneity of the yttria stabilizer distribution throughout the zirconia crystal lattice.
With respect to claim 12, Hauptmann as applied to claim 1 above further teaches that the zirconia molded body or the zirconia pre-sintered body has a predetermined shape of a dental product (“a process of producing a dental zirconia restoration”, Pa [0018]).
With respect to claim 13, Hauptmann as applied to claim 12 above further teaches that the dental product is a dental prosthesis (“crowns (including monolithic crowns), …veneers”, Pa [0029]).
With respect to claims 14 and 16, Hauptmann as applied to claim 1 above teaches that the starting temperature in the first increase is room temperature to 200°C in H1 (“With such heating rates a temperature increase of at least 180 to 240° C./min can be obtained.”, Pa [0072]; “the temperature where the sintering of the dental porous zirconia article starts can be reached within a time frame of 4 to 8 min.”, Pa [0073]; “temperature of the first heat-treating segment is typically in the range of 1,200 to 1,400° C.”, Pa [0076]; it provides that the stating temperature is between 0° C and 680° C. In the case where claimed ranges “overlap or lie inside ranges disclosed by prior art” a prima facie case of obviousness exists. (See MPEP 2144.05 (I)).
With respect to claim 15, Hauptmann as applied to claim 1 above further teaches that the starting temperature in the second temperature increase is 950 to 1230°C in H2 (“the first heat-treating segment is typically followed by a second heat-treating segment back-to-back (i.e. without interruption)”, Pa [0079]; “temperature of the first heat-treating segment is typically in the range of 1,200 to 1,400° C”, Pa [0076]; In the case where claimed ranges “overlap or lie inside ranges disclosed by prior art” a prima facie case of obviousness exists. (See MPEP 2144.05 (I)).
With respect to claim 17, Hauptmann as applied to claim 1 above further teaches that the starting temperature in the second temperature increase is 1000 to 1220°C in H2 (“the first heat-treating segment is typically followed by a second heat-treating segment back-to-back (i.e. without interruption)”, Pa [0079]; “temperature of the first heat-treating segment is typically in the range of 1,200 to 1,400° C”, Pa [0076]; In the case where claimed ranges “overlap or lie inside ranges disclosed by prior art” a prima facie case of obviousness exists. (See MPEP 2144.05 (I)).
With respect to claim 18, Hauptmann as applied to claim 1 above further teaches that the starting temperature in the second temperature increase is 1050 to 1200°C in H2 (“the first heat-treating segment is typically followed by a second heat-treating segment back-to-back (i.e. without interruption)”, Pa [0079]; “temperature of the first heat-treating segment is typically in the range of 1,200 to 1,400° C”, Pa [0076]; In the case where claimed ranges “overlap or lie inside ranges disclosed by prior art” a prima facie case of obviousness exists. (See MPEP 2144.05 (I)).
With respect to claim 19, Hauptmann as applied to claim 1 above further teaches that the HR1 is 60 to 450°C/min (“A first segment of heat-treating is done with a heating rate of … at least 180 to 240° C./min”, Pa [0072]).
With respect to claim 20, Hauptmann as applied to claim 1 above further teaches that the HR1 is 70 to 400°C/min (“A first segment of heat-treating is done with a heating rate of … at least 180 to 240° C./min”, Pa [0072]).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Hauptmann et al. (US 2021/0093517) as applied to claim 1 above, and further in view of Matsui et al. (US 2022/0212999).
With respect to claim 8, Hauptmann as applied to claim 1 above does not explicitly teach that 55% or more of the zirconia pre-sintered body is crystalline and crystalizes in a monoclinic crystal system.
In the same field of endeavor, a sintered body containing zirconia and a method for producing the sintered body or powder, Matshui teaches that the sintered body according to the present embodiment may be produced by any method and is preferably produced by a method comprising using as a raw material a powder that contains a stabilizer and zirconia with a monoclinic fraction of more than 70%, wherein monoclinic zirconia has a crystallite size of more than 23 nm and 80 nm or less, and such a powder may be formed and sintered by a known method (Pa [0086])
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Hauptmann with the teachings of Matshui and provide Matshui’s zirconia with a monoclinic fraction of more than 70% in Hauptmann’s method for the purpose of producing a zirconia sintered body, since it has been held that Applying a known technique to a known device (method or product) ready for improvement to yield predictable results is likely to be obvious. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, D.).
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.
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/YUNJU KIM/Primary Examiner, Art Unit 1742