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 .
Claim Objections
Claims 1 and 12 are objected to because of the following informalities:
In reference to claim 1, in line 12 after “the blank is” and before “circular-arc-”, it is suggested to delete “at least partially”, in order to ensure consistency in the claim language. Appropriate correction is required.
In reference to claim 12, in line 2 after “wherein the” and before “circular-arc-”, it is suggested to delete “at least partially”, in order to ensure consistency in the claim language. Appropriate correction is required.
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, 3-7, 9-15 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) and 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 claims 1, 3-6 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 (1) vertex lines of the convex portions, viewed in a plan view of the boundary surface, extend radially in a mesial-distal direction and (2) the white part has a color gradient, as presently claimed.
With respect to (1), 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 a 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 the 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 the 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.
With respect to (2), 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 a 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.
Kato in view of Geier and Ito 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 and Ito 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
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undercuts using short milling cutters (Geier, [0087]).
In reference to claim 7, Kato in view of Geier and Ito 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 and Ito 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 10, Kato in view of Geier teaches the limitations of claim 1, as discussed above. Kato in view of Geier and Ito teaches the zirconium material of the white part, additional layer and gingival color part are a 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 (Ito, [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 (Ito, [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).
In reference to claim 11, Kato in view of Geier and Ito 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 and Ito 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 and Ito 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 18, Kato in view of Geier and Ito teaches the limitations of claim 1, as discussed above. Kato in view of Geier and Ito 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 7 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Kato in view of Geier and Ito 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 and Ito 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 and Ito 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 and Ito be the ceramic material of the pink colored layer 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 and Ito 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 and Ito teaches the limitations of claim 1, as discussed above.
Kato in view of Geier and Ito 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 and Ito 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).
Response to Arguments
In response to amended claim 1, 3, 6-8, 12, 14-15 and cancelled claim 16, the previous Claim Objections of record are withdrawn. However, the amendments necessitate a new set of Claim Objections, as discussed above.
In response to amended claim 6, the previous 35 USC 112(b) rejections of record are withdrawn.
Applicant primarily argues:
“The Examiner's combination does not account for the claimed geometry as a coordinated system. Reference is made to the Declaration Under Rule 132 by José Pulido, a co-inventor in this application. The Declaration is being submitted along with this response. While Geier discloses a wave-shaped boundary, the Declaration explains that the claimed invention is not merely directed to a waveform, but to a specific geometric configuration of the boundary surface in the course of a dental arch in combination with a defined angular relationship and material system, which together produce technical effects not achieved in the prior art.
The claimed angular range (2.0°-4.5°) is critical and produces unexpected results. Conventional blanks (e.g., acrylic/PMMA) use angles ≥ 5°. The claimed range is 2.0°-4.5°. This reduction increases vertical space, improves anatomical tooth reproduction, enhances color/translucency transition and produces a more natural appearance.
The Examiner asserts that varying the angle would have been an obvious matter of design choice. However, the Declaration ( 10-12) demonstrates that this is not the case.”
Remarks, p. 10
The examiner respectfully traverses as follows:
The Declaration filed 05/13/2026 has been fully considered. However, the Declaration does not provide any evidence (i.e., data) to support the position that the claimed angular range produces unexpected results.
Attorney argument cannot take the place of evidence where evidence (i.e., data) is required. It is noted that “the arguments of counsel cannot take the place of evidence in the record”, In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965). It is the examiner’s position that the arguments provided by the Applicant regarding unexpected results and the criticality of the claimed angular range of 2.0º-4.5º must be supported by evidence (i.e., data) in a declaration or affidavit. As set forth in MPEP 716.02(g), “the reason for requiring evidence in a declaration or affidavit form is to obtain the assurances that any statements or representations made are correct, as provided by 35 U.S.C. 24 and 18 U.S.C. 1001”.
Applicant further argues:
“The Examiner relies on Ito to supply a composition gradient. However, as explained in the Declaration (¶11), the improved color and translucency gradient is not merely a result of material composition, but arises from the interaction between the reduced angular configuration and the boundary geometry, which increases the available transition zone within the restoration.
Neither Ito, Kato nor Geier recognize or suggest that modifying the geometric relationship of the boundary surface, particularly the claimed angular range, would enhance or control gradient effects in this manner.
The claimed invention overcomes the larger angles of the prior art PMMA systems. The claimed invention uses a smaller angle enabled by zirconia, which leads to improved manufacturability and aesthetics.
In view of the foregoing, even if the references were combined, there would have been no reasonable expectation that modifying the geometry of Kato in view of Geier and further incorporating Ito would result in the unexpected improvements described in the Declaration.
The Declaration provides evidence that the claimed angular range and geometric configuration are not arbitrary, but instead produce unexpected and synergistic effects in dental restorations. For all the reasons stated, the claims are not rendered obvious by the combination of Kato, Geier and Ito.”
Remarks, p. 11-12
The examiner respectfully traverses as follows:
It is noted the claims only require the second layer has a color gradient, the claims do not require a translucency gradient. As discussed in the rejection above, Kato in view of Geier and Ito teaches a blank having a second layer with a color gradient and the claimed angle between a fictious straight line and a projection of the fictious straight line onto a base surface of the circular-arc-shape blank, as claimed.
The reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by Applicant. See, e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed.Cir. 2006); Cross Med. Prods., Inc. v. Medtronic Sofamor Danek, Inc., 424 F.3d 1293, 1323, 76 USPQ2d 1662,1685 (Fed. Cir. 2005); In re Linter, 458 F.2d 1013, 173 USPQ 560 (CCPA 1972) (discussed below); In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1990), cert. denied, 500 U.S. 904 (1991). MPEP 2144 IV.
Further, as noted above the Applicant has not provided any evidence (i.e., data) to support the claimed angular range produces unexpected effects.
Therefore, Applicant's arguments filed 05/13/2026 have been fully considered but they are not persuasive.
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 Mary I Omori whose telephone number is (571)270-1203. The examiner can normally be reached M-F 8am-4pm.
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, Humera Sheikh can be reached at (571) 272-0604. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARY I OMORI/Primary Examiner, Art Unit 1784
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