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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/14/2025 has been entered.
Response to Amendment
In view of the amendment received 11/14/2025, the 35 U.S.C. 103 rejection of claim 4 has been withdrawn from the previous office action.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 6-7, and 9-18 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. the claimed "a peak-to-valley depth of 0.5-2 mm" of the element on line 12 of amended claim 1 does not appear to be supported in the specification as originally filed. On this metric, the specification appears only to state in [0073] of the published application that the distance between the elevation (peak) and the valley (depression) should be approximately 1/5 of the height of all layers.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 6-7, and 9-18 are rejected under 35 U.S.C. 103 as being unpatentable over Reusch (Foreign Publication WO2016071301A1) in view of Nagayama (Published Application US20200262759A1), Volkl (Published Application US20170273764A1), and Schulter (Published Application US20200078143A1).
Regarding claim 1, Reusch discloses a method for producing a ceramic multilayer blank (page 20 lines 6-10, method of producing multilayer multicolored blank) comprising the steps of:
filling at least a first layer of a first ceramic material in pourable condition into a mold (page 20 lines 19-20, layers filled inside the mold layer by layer);
filling at least a second layer of a second ceramic material in pourable condition into the mold (page 20 lines 19-20, layers filled inside the mold layer by layer; page 20 lines 9-10 2 to 6 layers);
wherein the first layer and the second layer are made of ceramic materials of different compositions (page 20 lines 16-17 layers of different compositions), which are filled in pourable condition layer-by-layer into the mold (page 20 lines 19-20, layers filled inside the mold layer by layer);
pressing the ceramic materials together within the mold to form a multilayer blank, and sintering the ceramic multilayer blank (page 20 lines 20-21, pressing biaxially with 100MPa, followed by sintering at 900°C),
wherein the first layer is a pink colored layer (claims 2 and 9, erbium nitrate solution used for forming coloring oxide; page 20 lines 19-20, layer by layer) and the second layer is a first tooth-colored layer (page 20 table 4, VITA dental shades for tooth color), and
wherein the first ceramic material includes erbium oxide (claims 2 and 9, erbium nitrate solution used for forming coloring oxide), further comprising filling the mold with a plurality of additional layers, wherein each of said additional layers is made of a ceramic material, which has a different composition than the first layer, and which has a different or identical composition than the second layer (page 20 lines 19-20, layers filled inside the mold layer by layer; page 20 lines 9-10 2 to 6 layers; page 21 table 4, 4 layers with 4 different compositions).
Reusch further discloses the use of a dental CAD/CAM machine for forming the blank into a dental restoration by machining (page 6 lines 1-6). Implicitly, the limitations of the step of digitally positioning the restoration to be formed from the blank, generating a digital model of the restoration to be manufactured, generating a digital model of the ceramic multilayer blank, and virtually aligning the digital models are met, since CAD/CAM dentistry requires the digital models of the blank and restoration to be manufactured to be generated in order to align the models with one another for creating the necessary software instructions that result in the restoration being machined from the blank.
Reusch does not explicitly disclose:
the first ceramic material including 2 to 25 wt% erbium oxide;
for each layer after the first, macro-structuring the exposed surface of the previously poured layer across its full area using an element with a strictly periodic wave-like, comb-like, or saw-tooth profile, said profile having a peak-to-peak spacing of 1-3 mm and a peak-to-valley depth of 0.5-2 mm, and thereafter, the next layer of a ceramic material in pourable condition is filled into the mold, wherein the volumes of the elevations and depressions are substantially equal, wherein the macro-structuring and pouring steps are repeated for each additional layer until all layers in pourable condition are filled into the mold;
and Reusch further does not explicitly recite the step of digitally positioning a restoration to be formed from the blank such that a future area of human gingiva is located completely inside of the first ceramic layer of the blank, and
virtually aligning the digital models to ensure the future gingival contact area of the restoration is positioned entirely within the pink-colored first ceramic layer prior to manufacturing the restoration;
wherein the pink-colored first ceramic layer comprises sufficient erbium oxide to match natural gingiva coloring.
In the analogous art of ceramic dental prosthesis molding ([0126] dental materials), Nagayama discloses an erbium oxide content of roughly 8.8 wt% of the composite ([0166] 3.2 mol% erbium oxide stabilized zirconia, which makes up 94.64 wt% of the composite) in order to impart a pink color, which is well within the claimed range of 2 to 25 wt%.
Further, example 1-1 of Nagayama results in a pale pink color ([0171]), where for instance in example 2-1, the percentage of 3.2 mol% erbium oxide stabilized zirconia makes up 97 wt% of the composite ([0193]), and results in a bright pink color ([0196]).
Since the pinkness is a variable that can be modified, among others, by adjusting said erbium oxide content, with said pinkness increasing in the first layer as the erbium oxide content is increased, the amount of erbium oxide would have been considered a result effective variable by one having ordinary skill in the art before the effective filing date of the present invention. As such, without showing unexpected results, the claimed 2 to 25 wt% of erbium oxide cannot be considered critical. Accordingly, one of ordinary skill in the art before the effective filing date of the present invention would have optimized, by routine experimentation, the erbium oxide content in the method of Reusch to obtain the desired level of pinkness of the first layer which is sufficient to match natural gingiva coloring, as claimed, such as the 8.8 wt% disclosed by Nagayama, since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (MPEP 2144.05 II).
In the analogous art of ceramic molding, Volkl discloses:
wherein after filling of the second layer ([0169] first layer 114) of the second ceramic material in pourable condition, a surface of the second layer (114) is structured using an element (116) with a strictly periodic wave-like, comb-like, or saw tooth section (Fig 8b, Fig 9, [0169] pattern imparted on first layer 114 by element 116 which has a serrated sawtooth geometry, leaving peaks and valleys in the layer)), said profile having a peak-to-peak spacing of 1-3 mm ([0038]) and a peak-to-valley depth of approximately 1/5 the height of all layers ([0169], also as disclosed in [0073] of the present specification of the present published application), and thereafter, the next layer (124) of a ceramic material in pourable condition is filled into the mold (110) ([0179] Fig 8c second layer 124 material penetrates to bottom of valleys 126 resulting in a continuous transition between layers after pressing), and wherein the volumes of the elevations and depressions are substantially equal ([0037] volume of elevations is equal or approximately equal to volume of depressions or valleys).
Volkl further discloses the method as being useful to produce a dental restoration without any compelling need to manually apply a veneering ceramic to the incisal, and enabling the adjustment of the strength by way of the composition of the ceramic materials, so that the highest flexural strength is attained in the region with the highest loads ([0065]), and to result in a continuous transition between layers after pressing ([0179]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the present invention, to modify the method of Reusch with the formation of peaks and valleys in the layers disclosed by Volkl in order to impart high strength to the preform, and to produce a dental restoration without any compelling need to manually apply a veneering ceramic to the incisal, and enabling the adjustment of the strength by way of the composition of the ceramic materials, so that the highest flexural strength is attained in the region with the highest loads, and to result in a continuous transition between layers after pressing, as suggested by Volkl ([0065]; [0179]).
It would further have been obvious to perform the macro-structuring disclosed by Volkl between each successive layer of ceramic material filled into the mold in order to apply the continuous transition to a higher amount of layers for a more complex gradient and since this repetitious technique was also applied in the other embodiment disclosed by Volkl ([0150] after filling second ceramic material 20 into cavity 18, second cavity 36 may be created and subsequently third ceramic material 38 is filled which may also have a cavity 40 formed in it thereafter).
As the length of layer transition of adjacent layers of the blank is/are variable(s) that can be modified, among others, by adjusting the peak to valley depth of the element, with the length of layer transition increasing as the peak to valley depth is increased, the peak to valley depth would have been considered a result effective variable by one having ordinary skill in the art before the effective filing date of the present invention. As such, without showing unexpected results, the claimed peak to valley depth cannot be considered critical. Accordingly, one of ordinary skill in the art, before the effective filing date of the present invention, would have optimized, by routine experimentation, the peak to valley depth of the element in the invention of modified Reusch to obtain the desired gradient for the color transition between layers of the blank (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223).
In a further analogous art of dental prosthesis manufacturing, Schulter discloses digitally aligning the final restoration product with the blank, while taking into account tooth position and gingiva contours of the final prosthesis prior to manufacturing the restoration ([0149]),
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the present invention, to further modify Reusch with the digital alignment step disclosed by Schulter and to ensure the pink portions of the dental restoration are aligned with the gingiva (which is also pink) in order to form a dental restoration by CAD/CAM machining that is suitable for implantation in a patient where colors of the restoration respectively match the colors of the rest of the patient’s teeth and gingiva, resulting in an aesthetically pleasing and convincing dental prosthesis.
Regarding claim 6, Reusch further discloses wherein the ceramic multilayer blank includes two to five additional layers (example 4, page 20 line 10, 2 to 6 layers).
Regarding claim 7, Reusch further discloses wherein the ceramic material of the second layer and/or the ceramic material of the third layer includes at least one oxide of the elements selected from the group consisting of Mn, Co, Fe, and Er (page 16 lines 7-10, Mn2O3, Er2O3, Co2O3, Fe2O3); and wherein the ceramic material of the first layer further comprises at least one oxide of the elements selected from the group consisting of Mn, Co, and Fe (page 16 lines 7-10, Mn2O3, Co2O3, Fe2O3).
Regarding claim 9, Reusch further discloses wherein the ceramic material of the first layer and/or the ceramic material of the second layer and/or the ceramic material of the third layer and/or the ceramic material of all additional layers of the ceramic multilayer blank further comprises between 0.0005 and 0.02 wt% of an oxide of the element Mn (page 16 line 10, 0.001-0.01 wt% Mn2O3); or the ceramic material of the first layer and/or the ceramic material of the second layer and/or the ceramic material of the third layer and/or the ceramic material of all additional layers of the ceramic multilayer blank further comprises between 0.0005 and 0.1 wt% of an oxide of the element Co (page 16 line 9, 0.001-0.01 wt% Co2O3).
Regarding claim 10, Reusch further discloses the general principle of defining a smooth color gradient with 2 to 6 layer fillings by using proportionally increasing and decreasing amounts of respective coloring oxides in each of the layers (page 20 lines 9-13).
Modified Reusch is silent on specifically the wt% of the at least one oxide of the element Mn continuously increasing from the second layer to the third layer or from the second layer via a first of the additional layers continuously further to a last layer added.
Since Reusch teaches the general principle of defining a smooth color gradient with 2 to 6 layer fillings by using proportionally increasing and decreasing amounts of respective coloring oxides in each of the layers (page 20 lines 9-13) and the parameters of the composition weight required in the invention, through routine experimentation, one ordinary skill in the art would find the workable range of each layer. 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 (MPEP 2144.05 II A). It is clear that each oxide, described as ‘coloring oxides’ by Reusch (page 6 lines 24-32), would each be considered result-effective variables, with the color of the composite being tunable according to the amount of each coloring oxide used, for example as explained with erbium oxide referenced above in the 35 U.S.C. 103 rejection of claim 1. One skilled in the art, before the effective filing date of the present invention, would have optimized the amount of coloring oxide in each layer to tune the color of each layer and achieve the desired final appearance of the multicolored blank.
Regarding claim 11, Reusch discloses wherein the ceramic multilayer blank is substantially or completely, free of any oxide of the element Co (page 16 lines 9-10, Co and Mn oxides recited in alternative).
Modified Reusch is further silent on wherein the wt% of the at least one oxide of the element Mn continuously increases specifically by a total of 1 to 50 ppm from the second layer to the third layer or from the second layer to a last layer added.
It would however have been obvious to one of ordinary skill in the art, before the effective filing date of the present invention, to further modify Reusch to increase the content of the Mn oxide from 1 to 50ppm in order to achieve the desired color gradient, and as a matter of routine optimization of a result effective variable, since the proportional amount of the coloring oxide in a given layer relates directly to the color imparted to the layer by the coloring oxide as stated in the above rejection of claim 10, which includes the establishment of the result effective variable.
Regarding claim 12, Reusch further discloses the general principle of defining a smooth color gradient with 2 to 6 layer fillings by using proportionally increasing and decreasing amounts of respective coloring oxides in each of the layers (page 20 lines 9-13).
Modified Reusch is silent on specifically the wt% of the at least one oxide of the element Co continuously increasing from the second layer to the third layer or from the second layer via a first of the additional layers continuously further to a last layer added.
Since Reusch teaches the general principle of defining a smooth color gradient with 2 to 6 layer fillings by using proportionally increasing and decreasing amounts of respective coloring oxides in each of the layers (page 20 lines 9-13) and the parameters of the composition weight required in the invention, through routine experimentation, one ordinary skill in the art would find the workable range of each layer. 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 (MPEP 2144.05 II A). It is clear that each oxide, described as ‘coloring oxides’ by Reusch (page 6 lines 24-32), would each be considered result-effective variables, with the color of the composite being tunable according to the amount of each coloring oxide used, as is the case with erbium oxide referenced above in the 35 U.S.C. 103 rejection of claim 1. One skilled in the art, before the effective filing date of the present invention, would have optimized the amount of coloring oxide in each layer to tune the color of each layer and achieve the desired final appearance of the multicolored blank.
Regarding claim 13, Reusch discloses wherein the ceramic multilayer blank is substantially or completely, free of any oxide of the element Mn (page 16 lines 9-10, Co and Mn oxides recited in alternative).
Modified Reusch is further silent on wherein the wt% of the at least one oxide of the element Co continuously increases specifically by a total of 1 to 100 ppm from the second layer to the third layer or from the second layer to a last layer added.
It would however have been obvious to one of ordinary skill in the art, before the effective filing date of the present invention, to further modify Reusch to increase the content of the Co oxide from 1 to 100ppm in order to achieve the desired color gradient, and as a matter of routine optimization of a result effective variable, since the proportional amount of the coloring oxide in a given layer relates directly to the color imparted to the layer by the coloring oxide as stated in the above rejection of claim 12, which includes the establishment of the result effective variable.
Regarding claim 14, Reusch discloses the use of Co or Mn oxides in the cited layers (page 16 lines 9-10), and the general principle of defining a smooth color gradient with 2 to 6 layer fillings by using proportionally increasing and decreasing amounts of respective coloring oxides in each of the layers (page 20 lines 9-13).
Modified Reusch is silent on the use of both Co and Mn oxides in the cited layers, and specifically the wt% of the oxides of the elements Mn and Co continuously increasing from the second layer to the third layer or from the second layer via a first of the additional layers continuously further to a last layer added.
Since Reusch teaches the general principle of defining a smooth color gradient with 2 to 6 layer fillings by using proportionally increasing and decreasing amounts of respective coloring oxides in each of the layers (page 20 lines 9-13) and the parameters of the composition weight required in the invention, through routine experimentation, one ordinary skill in the art would find the workable range of each layer. 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 (MPEP 2144.05 II A). It is clear that each oxide, described as ‘coloring oxides’ by Reusch (page 6 lines 24-32), would each be considered result-effective variables, with the color of the composite being tunable according to the amount of each coloring oxide used, for example as explained in the case with erbium oxide referenced above in the 35 U.S.C. 103 rejection of claim 1. One skilled in the art, before the effective filing date of the present invention, would have optimized the amounts of coloring oxides, including using both Co and Mn oxides in the same layers, in each layer in order tune the color of each layer and achieve the desired final appearance of the multicolored blank.
Regarding claim 15, Modified Reusch is further silent on wherein the wt% of the oxides of the elements Mn and Co continuously increases for the oxide of the element Mn specifically by a total of 1 to 35 ppm while continuously increasing for the oxide of the element Co by a total of 1 to 70 ppm from the second layer to the third layer or from the second layer to a last layer added.
It would however have been obvious to one of ordinary skill in the art, before the effective filing date of the present invention, to further modify Reusch to increase the content of the Mn oxide from 1 to 35ppm while increasing the content of the Co oxide from 1 to 70ppm in order to achieve the desired color gradient, and as a matter of routine optimization of a result effective variable, since the proportional amount of the coloring oxide in a given layer relates directly to the color imparted to the layer by the coloring oxide as stated in the above rejection of claim 14, which includes the establishment of the result effective variable.
Regarding claim 16, Reusch discloses the use of Co or Mn oxides in the cited layers (page 16 lines 9-10) and Fe and Er oxides (page 16 lines 7-8), and the general principle of defining a smooth color gradient with 2 to 6 layer fillings by using proportionally increasing and decreasing amounts of respective coloring oxides in each of the layers (page 20 lines 9-13).
Modified Reusch is silent on the use of both Co and Mn oxides in the cited layers, and specifically the wt% of the oxides of the elements Mn and Co continuously increasing from the second layer to the third layer or from the second layer via a first of the additional layers continuously further to a last layer added, and the content of at least one oxide of the elements Fe, Tb, Pr, and Er continuously decreasing from the second layer to the third layer; or from the second layer via the first of the additional layers continuously further to a last layer added.
Since Reusch teaches the general principle of defining a smooth color gradient with 2 to 6 layer fillings by using proportionally increasing and decreasing amounts of respective coloring oxides in each of the layers (page 20 lines 9-13) and the parameters of the composition weight required in the invention, through routine experimentation, one ordinary skill in the art would find the workable range of each layer. 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 (MPEP 2144.05 II A). It is clear that each oxide, described as ‘coloring oxides’ by Reusch (page 6 lines 24-32), would each be considered result-effective variables, with the color of the composite being tunable according to the amount of each coloring oxide used, for example as explained in the case with erbium oxide referenced above in the 35 U.S.C. 103 rejection of claim 1. One skilled in the art, before the effective filing date of the present invention, would have optimized the amounts of coloring oxides, including using both Co and Mn oxides in the same layers, in each layer in order tune the color of each layer and achieve the desired final appearance of the multicolored blank.
Regarding claim 17, Reusch further discloses wherein the ceramic material of all layers of the ceramic multilayer blank comprises zirconium dioxide doped with yttrium oxide (Y2O3), wherein the zirconium dioxide is doped with yttrium oxide, wherein the percentage of yttrium oxide in the layers other than the first layer is between 1 wt% and 15 wt% (page 11 lines 10-12, zirconium oxide, yttrium oxide, 5.2 wt%; page 12 lines 13-17, ratio between granulate and coloring solution ranges from 20:1 to 5:1; 1000g of 3Y-TZP granulate would have 52g of yttrium oxide for 5.2%, and adding 50g of coloring solution per the 20:1 ratio would yield 4.95% yttrium oxide in the colored granulate or 4.33% yttrium oxide in the colored granulate for the 5:1 ratio for any layer of the blank, both well within the claimed range of between 1 wt% and 15 wt%).
Regarding claim 18, Reusch further discloses wherein the ceramic material of all layers of the ceramic multilayer blank comprises zirconium dioxide doped with yttrium oxide (Y2O3), wherein the zirconium dioxide is doped with yttrium oxide, wherein the percentage of yttrium oxide in the pink colored layer is between 0.3 wt% and 10.5 wt% (page 11 lines 10-12, zirconium oxide, yttrium oxide, 5.2 wt%; page 12 lines 13-17, ratio between granulate and coloring solution ranges from 20:1 to 5:1; 1000g of 3Y-TZP granulate would have 52g of yttrium oxide for 5.2%, and adding 50g of coloring solution per the 20:1 ratio would yield 4.95% yttrium oxide in the colored granulate or 4.33% yttrium oxide in the colored granulate for the 5:1 ratio for any layer of the blank, both well within the claimed range of between 1 wt% and 15 wt%).
Response to Arguments
Applicant’s arguments received 11/14/2025 with respect to amended claim(s) 1 have been considered but they are not persuasive.
In response to applicant's argument regarding claim 1 on page 7 of applicant's remarks that Volkl provides no guidance or suggestion regarding the repetition of the interface restructuring process for every subsequent layer, the examiner disagrees. As stated in the rejection above, Volkl discloses this repetition for the other embodiment: [0150] “…after filling the second ceramic material 20 into the cavity 18, a second cavity 36 may possibly be created…” and subsequently a third ceramic material 38 is filled which may also have a cavity 40 formed in it thereafter.
In response to applicant's argument regarding claim 1 on page 7 of applicant's remarks that Volkl is silent on any quantitative geometric parameters, such as the required periodicity, spacing, depth, or volumetric equality of the structured surface, the examiner disagrees, and notes as stated above in the rejection, that Volkl discloses the profile having a peak-to-peak spacing of 1-3 mm ([0038]) and a peak-to-valley depth of approximately 1/5 the height of all layers ([0169]), the latter of which is identically disclosed in the present specification in paragraph [0073], while the 0.5-2 mm valley depth to peak distance claimed further is absent from the present disclosure.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIMOTHY HEMINGWAY whose telephone number is (571)272-0235. The examiner can normally be reached M-Th 6-4.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Susan Leong can be reached at (571) 270-1487. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/T.G.H./Examiner, Art Unit 1754
/SUSAN D LEONG/ Supervisory Patent Examiner, Art Unit 1754