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 .
Election/Restrictions
Applicant’s election of Group I, claims 1-18, in the reply filed on 12/12/2025 is acknowledged. Because Applicant did not distinctly and specifically point out the supposed errors in the restriction requirement between Groups I to III, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 19-21 and 23 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/12/2025.
Applicant's election with traverse of species (a-i), drawn to the second layer having a continuous color gradient, in the reply filed on 12/12/2025 is acknowledged. The traversal is on the grounds that the specification does not distinguish continuous and discontinuous gradients as patentably distinct species. This is not found persuasive because firstly, as Applicant notes the specification discloses the increase in the yttrium content may be continuous or incremental (p. 11, lines 23-24). This indicates the color gradient may be continuous or discontinuous. Thus, it is clear there are two distinct species of the color gradient of the second layer. However, the Applicant has amended the claims to remove the species set forth in Category A of the Office Action mailed 10/28/2025. Therefore, the restriction between species is withdrawn.
Claim Objections
Claims 1, 3, 6-8, 10, 12 and 14-16 are objected to because of the following informalities:
In reference to claim 1, it is suggested to (1) in line 3, after “based on” and before “zirconium”, insert “a”; (2) in line 4, after “based on” and before “zirconium”, insert “a”; (3) in line 7, amend “the course” to “a course” and (4) in line 10 after “viewed in” and “plan view”, insert “a”, in order to ensure consistency and proper antecedent basis in the claim language. Appropriate correction is required.
In reference to claim 3, in line 4, it is suggested to amend “the content” to “a content”, in order to ensure proper antecedent basis in the claim language. Appropriate correction is required.
In reference to claim 6, it is suggested to (1) in line 1, amend “blankaccording” to “blank according”; (2) in lines 7-8, amend “the proportion” to “a proportion”; (3) in line 8, amend “the amount” to “an amount” and (4) in line 9, amend “the sum of the amounts of substance” to “a sum of amounts of substances”, in order to ensure proper antecedent basis in the claim language. Appropriate correction is required.
In reference to claim 7, it is suggested to (1) in line 2, after “made of” and before “zirconium”, insert “the” and (2) in line 3 after “mixture of” and before “zirconium”, insert “the”, in order to ensure proper antecedent basis in the claim language. Appropriate correction is required.
In reference to claim 8, it is suggested to (1) in line 5, amend “the proportion of the amount of” to “a proportion of an amount of”; (2) in lines 6-7, amend “the sum of the amounts of substance” to “a sum of amounts of substances”; (3) in line 9, amend “the amount” to “an amount”; (4) in line 10, amend “the sum of the amounts of substance” to “a sum of amounts of substances” and (5) in line 11, amend “the sum of the erbium and yttrium” to “a sum of the erbium content and the yttrium”, in order to ensure proper antecedent basis in the claim language. Appropriate correction is required.
In reference to claim 12, in line 3 it is suggested to amend “the shape” to “a shape”, in order to ensure proper antecedent basis in the claim language. Appropriate correction is required.
In reference to claims 14 and 15, in line 2 after “viewed in” and before “plan view”, it is suggested to insert “the”, in order to ensure proper antecedent basis in the claim language. Appropriate correction is required.
In reference to claim 16, it is suggested to (1) in line 3, amend “the wave” to “a wave”; (2) in line 4, amend “the wave” to “a wave”; (3) in line 5, amend “the projection” to “a projection” and (4) in line 7, delete “,” before “.”, in order to ensure consistency and proper antecedent basis in the claim language. Appropriate correction is required.
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.
Claim 6 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.
In reference to claim 6, the limitation “the yttrium content” is recited in line 7. There is insufficient antecedent basis for this limitation in the claim. In order to ensure proper antecedent basis in the claim language, it is suggested to amend “the yttrium content” to “the yttrium content of the first layer and the yttrium content of the outer layer”.
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, 9, 11-16 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Kato et al. (US 2021/0128283) (Kato) in view of Geier et al. (US 2020/0015947) (Geier).
In reference to claims 1 and 14-15, Kato teaches a denture block having a two layer structure of a white part serving as a tooth part of the denture and a gingival colored part serving as a denture base part of the denture ([0035]) (corresponding to a blank for dental prostheses comprising a first layer; and a second layer). Zirconia is used as a material used for the white part and the gingival color part ([0040]-[0041]; [0058]) (corresponding to a first layer based on zirconium oxide ceramic and a second layer based on zirconium oxide ceramic). The zirconia of the white part and gingival color part differ in color ([0058]) (corresponding to the first layer and the second layer differing in color).
At a boundary part between the gingival color part and the white part there is a plurality of convex portions and concave portions ([0062]; [0063]; [0069]) (corresponding to the first layer and the second layer forming a boundary surface; the boundary surface is formed, in the course of dental arch, in an undulating shape with alternating wave troughs and wave crests).
Kato does not explicitly teach vertex lines of the convex portions, viewed in a plan view of the boundary surface, extend radially in a mesial-distal direction, as presently claimed.
Geier teaches a two-colored blank for a dental prosthesis ([0014]). The portion from which the dental arch will subsequently be formed is tooth-colored, and the portion from which the denture base will subsequently be formed is gum-colored ([0014]). A boundary surface exists between the materials which, as viewed along the course of the dental arch, extends in a wave-shaped manner ([0016]). The waveform is adapted to resemble the gingival margin ([0017]).
FIG. 2, provided below, shows a top view of the dental arch to be created in the blank disc ([0053]). The crests and troughs extend from a central region of the blank outwardly, in a ray shape (FIG.2) (corresponding to vertex lines of the wave crests, viewed in plan view of the boundary surface, extend radially in a mesial-distal direction). In a region of the anterior teeth, the crests and troughs of the undulating course extend radially ([0019]; FIGS. 1-6) (corresponding to the boundary surface, viewed in plan view of the boundary surface, in a region of anterior teeth to be produced has, in an oral-vestibular direction, vertex lines of wave crests in a fan shape). At least in the area of the molars the crests and troughs extend parallel to each other ([0021]) (corresponding to the boundary surface, viewed in plan view of the boundary surface, in a region of molars to be produced has, in an oral-buccal direction, radiating vertex lines of the wave troughs or vertex lines of the wave troughs which are substantially parallel to one another). This allows to improve both the function and the aesthetics of the dental prosthesis ([0022]).
In light of the motivation of Geier, it would have been obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention to have the boundary surface of Kato have the waveform of Geier, in order to provide a waveform that resemble the gingival margin and improve both the function and the aesthetics of the dental protheses, and
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thereby arriving at the presently claimed invention.
In reference to claim 7, Kato in view of Geier teaches the limitations of claim 1, as discussed above. Kato teaches as a material of the gingival color part zirconia (zirconium oxide) is used ([0041]; [0058]) (corresponding to the first layer is made of zirconium oxide ceramic).
In reference to claim 9, Kato in view of Geier teaches the limitations of claim 1, as discussed above. Kato further teaches the upper part of the block is a pre-colored white part serving as a tooth part of a denture, and a lower part is a pre-colored gingival color part serving as a denture base part ([0011]) (corresponding to the first layer is whitish or pinkish and the second layer is tooth-colored).
In reference to claim 11, Kato in view of Geier teaches the limitations of claim 1, as discussed above. Kato further teaches the white part and the gingival part are integrally formed by being brought into close contact with each other with no gap therebetween ([0011]; [0015]) (corresponding to the first layer and the second layer are connected to each other by integral manufacture).
Further, claim 11 defines the product by how the product was made. Thus, claim 11 is product-by-process claim. For purposes of examination, product-by-process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps. See MPEP 2113. In the present case, the recited steps imply a structure including the first layer and the second layer being integral. The reference suggests such a product.
In reference to claim 12, Kato in view of Geier teaches the limitations of claim 1, as discussed above. Kato teaches the denture block is a circular disc (FIGS. 1-3, 7-8 & 10-13) (corresponding to at least partially circular-arc-shaped and has the shape of a disc).
In reference to claim 13, Kato in view of Geier teaches the limitations of claim 1, as discussed above. Kato further teaches a ridge portion is formed at a vertical central portion of a side surface of the cylinder (Abstract; [0015]) (corresponding to a protrusion formed on an outer circumference of the blank). The ridge portion is gripped during the integral manufacture of the denture ([0015]) (corresponding to a protrusion having an outwardly projecting clamping edge).
In reference to claim 16, Kato in view of Geier teaches the limitations of claim 12, as discussed above. Kato in view of Geier further teaches the undulated course of the boundary surface is modelled to match a human gingival margin (Geier, [0060]). The recess in the distal region is deeper than the mesial region. This results in greater height of the tooth colored material in the distal direction than in the mesial direction (Geier, [0087]).
While Kato in view of Geier does not explicitly disclose an angle between a fictitious straight line connecting a lower point of a wave trough for a second molar to be produced with a lowest point of a wave trough for a central incisor to be produced and the projection of said fictitious straight line onto a base surface of the block being 2.0º to 4.5º as presently claimed, it has long been an axiom of United States patent law that it is not inventive to discover the optimum or workable ranges of result-effective variables by routine experimentation. In re Peterson, 315 F.3d 1325, 1330 (Fed. Cir. 2003) ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages."); In re Boesch, 617 F.2d 272, 276 (CCPA 1980) ("[D]iscovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art."); In re Aller, 220 F.2d 454, 456 (CCPA 1955) ("[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."). "Only if the 'results of optimizing a variable' are 'unexpectedly good' can a patent be obtained for the claimed critical range." In re Geisler, 116 F.3d 1465, 1470 (Fed. Cir. 1997) (quoting In re Antonie, 559 F.2d 618, 620 (CCPA 1977)).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention to vary the angle between the fictitious line and the base surface of the block of Kato in view of Geier, including over the presently claimed, in order to provide a gingival margin matching a human gingival margin and accurately and rapidly mill undercuts using short milling cutters (Geier, [0087]).
In reference to claim 18, Kato in view of Geier teaches the limitations of claim 12, as discussed above. Kato in view of Geier further teaches an angle between an occlusal plane and the rib (i.e., wave crest) can largely be adapted to the requirements, for example the angle can be 10 to 20 degrees (Geier, [0095]) (corresponding to an angle between a base surface of the circular-arc-shaped blank and a vertex line of the wave crests of the undulating boundary surface is 7º to 13º).
As set forth in MPEP 2144.05, in the case where the claimed range “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); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Claims 2-6 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Kato in view of Geier as applied to claim 1 above, and further in view of Kato et al. (WO 2020/138316) (Ito).
It is noted that when utilizing WO 2020/138316, the disclosures of the reference are based on US 2022/0017423 which is an English language equivalent of the reference. Therefore, the paragraphs cited with respect to WO 2020/138316 are found in US 2022/0017423.
In reference to claim 2-6, Kato in view of Geier teaches the limitations of claim 1, as discussed above.
Kato in view of Geier does not explicitly teach the white part has a color gradient, as presently claimed.
Ito teaches a zirconia pre-sintered body that can be fired into a sintered body having translucency and strength suited for dental use (Abstract). The zirconia pre-sintered body comprises a plurality of layers that differ from each other in content of the stabilizer relative to the total mole of the zirconia and the stabilizer, wherein the stabilizer is yttria ([0016]; [0038]) (corresponding to the second layer has a color gradient; the zirconium oxide ceramic of the second layer comprises yttrium and the color gradient is formed by a gradient of the content of yttrium). The yttria content relative to the total mole of zirconia and yttria in a layer containing one end of the zirconia per-sintered body is 4.5 mol% or more and 7.0 mol% or less ([0046]) (corresponding to the second layer comprises an outer layer; the outer layer being adjacent the outer surface of the second layer). When the yttria content in this layer is 4.5 mol% or more and 7.0 mol% or less, the zirconia sintered body has increased translucency, and such translucency is suited as the translucency of a cut end portion of a dental prosthesis ([0046]) (corresponding to the outer layer has an yttrium content from 3.5 to 8.0 mol%). Ito further teaches the yttria content relative to the total mole of zirconia and yttria in the layer containing the other end of the zirconia pre-sintered body is 2.0 mol% or more and less than 4.5 mol% ([0046]) (corresponding to the second layer comprises an inner layer; the inner layer has an yttrium content of from 2.0 to 6.0 mol%; the content of yttrium in the second layer increases from the boundary surface to an outer surface of the second layer opposite the boundary surface). This allows for a translucency suitable for a cervical portion of a dental prosthesis ([0046]).
Ito further teaches the zirconia pre-sintered body allows for the zirconia sintered body to have translucency changing gradually between its cervical portion and cut end portion, similar to that of a natural tooth ([0046]).
In light of the motivation of Ito, it would have been obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention to have the white part of Kato in view of Geier be a zirconia pre-sintered body including the plurality of layers that differ from each other in the content of yttria, in order to appropriately set the translucency and strength required for each portion of the zirconia sintered body obtained from the zirconia pre-sintered body and provide the sintered body with translucency similar to that of a natural tooth, and thereby arriving at the presently claimed invention.
In reference to claim 10, Kato in view of Geier teaches the limitations of claim 1, as discussed above. Kato in view of Geier further teaches an additional layer of material having different refractive properties between the white part and the gingival colored part (Geier, [0048]).
Ito teaches a zirconia pre-sintered body that can be fired into a sintered body having translucency and strength suited for dental use (Abstract). The zirconia pre-sintered body comprises a plurality of layers that differ from each other in content of the stabilizer relative to the total mole of the zirconia and the stabilizer ([0016]) (corresponding to the zirconium oxide ceramic are pre-sintered). The zirconia per-sintered body has a density of 2.7 to 4.0 g/cm3 ([0037]) (corresponding to the zirconium oxide ceramic have a density of 1.8 to 4.4 g/cm3).
As set forth in MPEP 2144.05, in the case where the claimed range “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); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Ito further teaches in view of achieving translucency and strength suited for dental use, zirconia in a zirconia pre-sintered body of the present invention needs to predominantly comprise a monoclinic crystal system ([0039]).
In light of the motivation of Ito, it would have been obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention to have the zirconium material of the white part, additional layer and gingival color part of Kato in view of Geier be pre-sintered zirconia including a stabilizer, in order to provide translucency and strength suited for dental use, and thereby arriving at the presently claimed invention.
Claims 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Kato in view of Geier as applied to claim 1 above, and further in view of Fecher et al. (WO 2022/132647) (Fecher).
In reference to claims 7 and 8, Kato in view of Geier teaches the limitations of claim 1, as discussed above. Kato further teaches the material used for the gingival color part is zirconia ([0041]; [0058]) (corresponding to the first layer is made of zirconium oxide ceramic).
Kato in view of Geier does not explicitly teach the zirconia comprises erbium and/or yttrium, as presently claimed.
Fecher teaches a ceramic multilayer blank comprising at least a first layer of a first ceramic material and at least a second layer of a second ceramic material (p. 1, lines 8-12). The first layer is a pink colored layer, wherein the first ceramic material comprises 2 to 25 wt% erbium oxide (p. 2, lines 24-25) (corresponding to the first layer comprising erbium; the first layer having an erbium content of 0.0 to 4.5 mol%, wherein the erbium content is defined as the proportion of the amount of substance of Er2O3 relative to the sum of the amounts of substance of Er2O3, ZrO2 and HfO2-). The pink colored ceramic material for dental restoration applications is similar to human gingiva (p. 2, lines 26-28). The percentage of yttrium oxide in the pink colored layer is between 0.3 wt% and 10.5 wt% (p. 6, line 32) (corresponding to the first layer comprises erbium and yttrium; an yttrium content of 0.0 to 4.5 mol%, wherein the yttrium content is defines as a proportion of the amount of substance of Y2O3 relative to the sum of the amounts of substance of Y2O3, ZrO2 and HfO2). Thus, it is clear the pink colored ceramic material has a sum of erbium oxide and yttrium oxide of 2.3 to 35.5 wt% (i.e., 2+0.3 = 2.3; 25+10.5 = 35.5) (corresponding to the sum of the erbium and yttrium content being 1.5 to 6.0 mol%).
While Fecher does not explicitly disclose the amount of erbium oxide and yttrium oxide in mol%, however, given that Fecher broadly disclose having 2 to 25 wt% erbium oxide and 0.3 wt% and 10.5 wt% yttrium oxide, it is clear that it would necessarily include the presently claimed (i.e., 0.0 to 4.5 mol % of erbium oxide and 0.0 to 4.5 mol% yttrium oxide).
As set forth in MPEP 2144.05, in the case where the claimed range “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); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
In light of the motivation of Fecher, it would have been obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention to have the zirconia material of the gingival color part of Kato in view of Geier be the ceramic material of the pink colored later of Fecher, in order to provide a gingival color part suitable for dental restorations and having a color similar to that of human gingiva, and thereby arriving at the presently claimed invention.
Further, as disclosed in Fecher the zirconia including yttrium and erbium is a known material for a gingival color part of a dental restoration blank and it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious engineering choice. In re Leshin, 125 USPQ 416.
The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination (MPEP 2144.07).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Kato in view of Geier as applied to claim 12 above, and further in view of Reusch (US 2022/01404925) (Reusch).
In reference to claim 17, Kato in view of Geier teaches the limitations of claim 12, as discussed above.
Kato in view of Geier does not explicitly teach the denture block has a height of not more than 30 mm or (i) a height of the gingival color part is 5.0 to 9.0 mm and/or (ii) a height of the white part is 15.0 to 25.0 mm, as presently claimed.
Reusch teaches a multi-layered zirconia dental blank (Abstract). The blank has a total height from 10 mm to 30 mm ([0134]) (corresponding to the denture block has a height of not more than 30 mm). The multi-layered zirconia dental blank includes a bottom having a colour resembling the dentin or cervical part of a tooth close to the gingiva, a top layer resembling the top enamel area of a tooth, at least two intermediate layers and at least two reverse layers between the bottom and top layers ([0015]-[0018];[0092]; [0095]-[0097]; [0111]-[0117]). The thickness of the top layer is from 1 mm to 5 mm, the thickness of the intermediate layers ranges from 0.6 mm to 5 mm, the thickness of the reverse layers ranges from 0.6 mm to 1.2 mm and the thickness of the bottom layer is 1 to 25 mm ([0135]-[0142]). Thus, it is clear the tooth colored part of the multi-layer zirconia dental blank is 3.4 mm to 28.4 mm (i.e., 1mm+ (4*0.6mm) = 3.4 mm) (corresponding to a height of the first layer is 5.0 to 9.0 mm; a height of the second layer is 15.0 to 25.0 mm).
As set forth in MPEP 2144.05, in the case where the claimed range “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); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
In light of the motivation of Reusch, it would have been obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention to have the block of Kato in view of Geier have a height between 10 and 30 mm with a white part having a height from 3.4 mm to 28.4 mm and a gingival color part from 1 to 25 mm, in order to provide a block suitable for making a dental prosthesis with a smooth colour and translucency gradient closely resembling the colour and translucency gradient of a natural tooth (Reusch, p. 3, lines 29-35).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Mary I Omori whose telephone number is (571)270-1203. The examiner can normally be reached M-F 8am-4pm.
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/MARY I OMORI/Primary Examiner, Art Unit 1784