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 .
Examiner’s Note
The Examiner acknowledges the amendments of claim 1. Claims 11 & 13 have been cancelled. Claims 12 & 14 were previously withdrawn from consideration. Claims 1 – 10 are examined herein.
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.
Claim(s) 1 – 7 & 9 – 10 are rejected under 35 U.S.C. 103 as being unpatentable over Kudo (*WO 2019/026811 A1).
*US2020/0369573 A1 is cited herein as the English language equivalent of WO 2019/0206811 A1
**Shinichi et al., “Measurement of odorous substances caused by pyrolysis materials, Journal of Environmental Laboratories Association,” (Journal of Environment Laboratories Association, (13), 1998, p. 150 – 154).
**Submitted by Applicant with IDS filed 12/04/2023
With regard to claim 1, Kudo (‘573) teaches a zirconia molded body comprising zirconia particles containing 2.0 – 9.0 mol% yttria (paragraphs [0010], [0042]), with an average particle diameter of 30 nm or less nm (paragraphs [0009], [0017], [0040]). Furthermore, the molded body comprises a plasticizer, and a binder. The plasticizer may include polyethylene glycol (PEG) or glycerin (i.e., “a polyol”) (paragraph [0073]).
Examples of the binder include polyvinyl alcohol (paragraph [0072]).
Kudo (‘573) teach working examples 15 & 16 comprises 2 mass% PEG2 (polyol) and 2 mass% PVA (binder) relative to the mass of zirconia, which is within Applicant’s claimed range of 0.01 – 8 mass% of 100 mass% of zirconia. Ex.15 polyvinyl alcohol in amount of 2 mass% relative to the mass of zirconia (paragraphs [0244] & [0246]), which is within Applicant’s claimed range of 0.01 – 10 mass% of binder relative to 100 mass% of zirconia. Furthermore, the ratio of binder:polyol is 1:1, which is within Applicant’s claimed range of 10:1 to 1:10. It would have been obvious to one of ordinary skill in the art to use the same amount of glycerin as PEG as the polyol used in the working examples because the reference teaches glycerin and PEG are functional equivalents used for the same purpose of behaving as a desiccant (paragraph [0073]).
Kudo (‘573) fails to explicitly teach the combustion temperatures of polyvinyl alcohol and polyethylene glycol are X1 < Y1 < X2 < Y2 ≤ 500°C.
**Shinichi et al. teach the loss of heating vs heating temperature (i.e., “combustion temperature”) start temperature and end temperature of the polyvinyl alcohol are about Y1 ~ 100°C and Y2 ~ 500°C (Fig. 2).
Furthermore, Applicant’s Table 1 (paragraph [0178]) teaches the combustion temperature of glycerin is in the range of 77 – 266°C (wherein X1 is 77°C and X2 is 266°C).
MPEP 2112 [R-3] states:
The express, implicit, and inherent disclosures of a prior art reference may be relied upon in the rejection of claims under 35 U.S.C. 102 or 103. “The inherent teaching of a prior art reference, a question of fact, arises both in the context of anticipation and obviousness.” In re Napier, 55 F.3d 610, 613, 34 USPQ2d 1782, 1784 (Fed. Cir. 1995) (affirmed a 35 U.S.C. 103 rejection based in part on inherent disclosure in one of the references). See also In re Grasselli, 713 F.2d 731, 739, 218 USPQ 769, 775 (Fed. Cir. 1983).
Therefore, Kudo (‘573) inherently teaches an embodiment in which glycerin (i.e., “a polyol”) has a combustion start temperature (X1) of 77°C, polyvinyl alcohol (binder) has a combustion start temperature (Y1) of about 100°C, glycerin has a combustion end temperature (X2) of 266°C, and polyvinyl alcohol has a combustion end temperature of about 500°C, such that X1 < Y1 < X2 < Y2 ~ 500°C.
With regard to claim 2, Kudo (‘573) teaches the zirconia powder was molded into a plate shape measuring 80 mm x 40 mm x 10 mm in size (paragraph [0208]), which is within Applicant’s claimed thickness range of 10 mm or more.
With regard to claim 3, as discussed above for claim 1, glycerin (i.e., “the polyol”) inherently has a combustion start temperature (X1) of 77°C, which is in the range of 50°C or higher.
With regard to claim 5, Kudo (‘573) teaches the molded body of zirconia powder has a crystal grain size of 180 nm or less after being sintered at 1100°C, which is within Applicant’s claimed range of 900 to 1200°C, under ordinary pressure (paragraph [0098]).
With regard to claim 6, Kudo (‘573) teaches the molded body has a three-point flexural strength of 500 MPa or more after being sintered at 1100°C under ordinary pressure (paragraph [0099), which is within Applicant’s claimed range of 900 – 1200°C under ordinary pressure.
With regard to claim 7, Kudo (‘573) teaches the molded body has a transmittance of 40% or more for light of 700 nm wavelength at a thickness of 0.5 mm after being sintered at 1100°C, which is within Applicant’s claimed range of 900 – 1200°C, under ordinary pressure (paragraphs [0017] & [0100]).
With regard to claim 9, Kudo (‘573) does not explicitly teach the molded body has ten or fewer pores with a diameter of 50 nm or more per 28.5 µm2 cross sectional area after being sintered at 900 – 1200°C under ordinary pressure.
However, Applicant’s specification, paragraph [0142], suggests the structural features of claim 9 are the inherent results of forming the molded zirconia body sintered of claim 1 in the range of 900 – 1200°C under ordinary pressure. Further, Kudo (‘573) teaches the same type of pore forming agent (i.e., glycerin or PEG). Therefore, Kudo (‘573) teach a zirconia body comprising zirconia-stabilized-yttria comprising the same amount of yttria, and pores that have been formed using the same type of pore-forming agent sintered at the same temperature and pressure as disclosed in Applicant’s specification.
It has been held that where the claimed and prior art products are identical or substantially identical in structure or are produced by identical or a substantially identical processes, a prima facie case of either anticipation or obviousness will be considered to have been established over functional limitations that stem from the claimed structure. In re Best, 195 USPQ 430, 433 (CCPA 1977), In re Spada, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). The prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed products. In re Best, 195 USPQ 430, 433 (CCPA 1977).
With regard to claims 4 & 10, Kudo (‘573) fails to explicitly teach the molded body has a ΔL*(W-B) of 5 or more at a thickness of 1.5 mm, including after being pre-sintered at 200 – 800°C.
However, Kudo (‘573) teaches a calcined zirconia body and a sintered zirconia body of similar composition and method of manufacturing as Applicant’s claimed pre-sintered zirconia body and sintered body (see table below).
As discussed above for claim 1, PEG (X1) does not have a lower combustion starting temperature than PVA (Y1) (despite the fact that Applicant’s teaches PEG and PVA as embodiments of the polyol and binder, respectively).
However, as discussed above for claim 1, Kudo (‘573) teach the plasticizer (i.e., polyol) of the body may include glycerol, which has a lower combustion starting temperature (X1) than PVA (Y1).
It would have been obvious to one of ordinary skill in the art to substitute the amount of PEG of examples 15 – 16 with the same amount of any of the plasticizers taught in the broader teachings of Kudo (‘573), such as glycerin.
Therefore, one of ordinary skill in the art would conclude the molded body taught by Kudo (‘573) inherently has the same property, such as a ΔL*(W-B) of 5 or more at a thickness of 1.5 mm after being pre-sintered at 200 – 800°C, as the zirconia molded body claimed by Applicant.
It has been held that where the claimed and prior art products are identical or substantially identical in structure or are produced by identical or a substantially identical processes, a prima facie case of either anticipation or obviousness will be considered to have been established over functional limitations that stem from the claimed structure. In re Best, 195 USPQ 430, 433 (CCPA 1977), In re Spada, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). The prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed products. In re Best, 195 USPQ 430, 433 (CCPA 1977).
Applicant’s originally filed specification
Kudo (‘573)
Composition
Zirconia particles w/2.0 – 9.0 mol% Yttria (claim 1)
Glycerin or PEG (¶70), wherein polyol content is equal to or less than binder content (¶79) and more than 0.01 mass% (P76).
Polyvinyl alcohol binder (¶71) should be present in the amount of 0.2 mass% or more and 7 mass% or less, relative to 100 mass% of zirconia (¶79).
Zirconia particles w/2.0 – 9.0 mol% Yttria (¶10 & ¶42)
Glycerin or PEG (¶73)
Polyvinyl alcohol binder (¶72).
Ex.15 polyvinyl alcohol in amount of 2 mass% relative to the mass of zirconia (¶244).
Ex. 16 PVA & PEG 2 mass% relative to zirconia (¶246)
Method of Pre-Sintering/Calcination
1.5 mm thickness pre-sintered body (claim 10)
Rate of temperature increase 0.5°C/min to 50°C/min (¶156)
200 – 800°C (claims 4 & 10) for 0.4 - 10 hours (¶157)
Electric furnace or debinding furnace (¶158)
Disc shape of 1.5 mm thickness calcined body (¶208)
700°C for 2 hours (¶208)
Ordinary pressure (¶208)
Electric furnace or debinding furnace (¶153)
Method of Sintering
900°C – 1200°C (¶44, ¶161) for 5 minutes or more and 6 hours or less (¶161)
Ordinary pressure (¶164)
Electric or debinding furnace (¶163)
900°C – 1200°C (¶167) for 5 minutes or more and 6 hours or less (¶168)
Ordinary pressure
Electric or debinding furnace (¶169)
Claim(s) 8 is rejected under 35 U.S.C. 103 as being unpatentable over Kudo (‘573), as applied to claim 1 above, and further in view of Cekic-Nagas et al. (“Light transmittance of zirconia as a function of thickness and microhardness of resin cements under different thickness of zirconia,” Med Oral Patol Oral Cir Bucal. 2013 Feb 5;18(2):e212–e218).
With regard to claim 8, Kudo (‘573) teach transmittance of light of 700 nm wavelength through a thickness of 0.5 mm in the zirconia sintered body at 1100°C under ordinary pressure is 35% or more (paragraphs [0178] & [0194] – [0195]).
Kudo (‘573) does not explicitly teach the molded body has a linear light transmittance of 1% or more at a thickness of 1.0 mm after being sintered at 900 – 1200°C under ordinary pressure.
Cekic-Nagas et al. teach the transparency of a zirconia body is inversely proportional to its thickness (abstract & e217).
Therefore, absent a showing of criticality with respect to thickness (a result effective variable), it would have been obvious to a person of ordinary skill in the art prior to the effective filing date to adjust the thickness through routine experimentation in order to achieve a zirconia body with the desired light transmittance properties. It has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Declaration
The declaration under 37 CFR 1.132 filed December 30, 2025 is insufficient to overcome the rejection of claims 1 – 10 based upon the rejections under 35 U.S.C. 102(a)(1) as set forth in the last Office action (or the rejections under 35 U.S.C. 103 as set forth in the current Office action) because:
Applicant’s showing is not commensurate in scope with the claims--; etc. See MPEP § 716.
It refer(s) only to the system described in the above referenced application and not to the individual claims of the application. Thus, there is no showing that the objective evidence of nonobviousness is commensurate in scope with the claims. See MPEP § 716.
In view of the foregoing, when all of the evidence is considered, the totality of the rebuttal evidence of nonobviousness fails to outweigh the evidence of obviousness.
Response to Arguments
Applicant argues, “This is especially the case now in view of Applicants’ above amendments to Claim 1, further requiring 0.01 – 8 mass % of a polyol relative to 100 mass% of zirconia, 0.01 – 10 mass, 0.01 – 10 mass % o a binder relative to 100 mass % of zirconia, a mass ratio of binder:polyol of 10:1 to 1:10, and that X1 be 200°C or less. Under no interpretation of the law of anticipation, including In re Petering, would Kudo ‘811 be considered to be anticipatory of the subject matter of Claim 1 under 35 U.S.C. 102(a)(1).
“The same situation obtains for Kudo WO 2020/0179876 (Kudo ‘876). As such, Applicants request the reconsideration and withdrawal of the anticipation rejection over these two references” (Remarks, Pg. 6).
EXAMINER’S RESPONSE: Agreed. In light of Applicant’s amendment of claim 1, the rejection over Kudo has now been modified as a rejection under 35 U.S.C. § 103 because it would have been obvious to one of ordinary skill in the art to substitute the polyol taught in the working examples with a functionally equivalent polyol taught in the broader teachings of the reference.
Applicant argues, “Essentially for these same reasons, Applicants request reconsideration of the obviousness rejections herein. Neither of Kudo references, even when supplemented by Cekic-Nagas, suggests what Applicants are claiming herein or the surprising and unexpected results provided by the claimed zirconia molded body” (Remarks, Pg. 6).
EXAMINER’S RESPONSE: Applicant's arguments have been fully considered but they are not persuasive. First, with regard to the obviousness of Applicant’s claimed subject matter, Applicant is directed to the discussion above regarding the fact that it would have been obvious to a person of ordinary skill in the art substitute the polyol of a working example with one of the functional equivalents disclosed in the broader teachings of the same reference.
With regard to Applicant’s assertion of unexpected results, Applicant is directed to the discussion above under the subtitle “Declaration” and a more thorough discussion of Applicant’s data below.
Applicant argues, “As noted in the Declaration, which largely forms the basis of the following comments, this application includes twelve examples and four comparative examples, these examples and comparative examples demonstrating the unexpected and superior properties provided by the presently claimed zirconia molded body. Importantly, and as emphasized by Examiner Gugliotta during the interview, these examples and comparative examples fully support the full scope of amended Claim 1.
“In particular, and as explained in the present application, the claimed zirconia molded body can be pre-sintered to provide a pre-sintered body (mill blank), which is then sintered after being cut (milled) into a shape of a desired dental prosthesis. Example 1 herein describes this process, resulting in zirconia sintered bodies, including crown-shaped dental prostheses. Comparative Examples 1 – 4 were similarly prepared using differing compositions, as shown in Table 3…Here, we see that, as compared to Comparative Example 4, Example 1 according to the present claims provides a material having a linear light transmittance that is six times higher, a light transmittance that is 22% higher, a number of pores 50 nm or larger that is one-third or less, and a three -point bending strength that is approximately five times higher” (Remarks, Pgs. 6 – 8).
EXAMINER’S RESPONSE: Applicant's arguments have been fully considered but they are not persuasive. Applicant’s examples only use one polyol (glycerin) and various types of acrylic binder (KFE-124). The polyol and the binder of Applicant’s independent claim 1 are not limited to these species. Applicant does not provide evidence for unexpected results based on other species of polyol and other types of binder within the claimed genus. Therefore, the evidence is not commensurate in scope with the claims. See MPEP § 716.
Example 1 comprised 1 mass% of glycerin and 2 mass% of acrylic binder KFE-124, both relative to 100 mass% of zirconia (spec, pg. 46, lines 2 – 4). Examples 2 – 11 of the specification have similar glycerin and acrylic binder KFE-124 content. Example 12 comprised 2 mass% polyol and 2 mass% binder content. Contrary to Applicant’s assertion, Applicant’s examples do not cover the entire claimed polyol range of 0.01 – 8 mass% or the entire claimed binder range of 0.01 – 10 mass%. Therefore, the evidence is not commensurate in scope with the claims. See MPEP § 716.
The declaration asserts the working examples have a linear light transmittance that is six times higher, a light transmittance 22% higher, a number of pores of 50 nm or larger that is one third or less, and a three-point bending strength that is approximately 5x higher than comparative examples.
Kudo ‘573 teaches the zirconium sintered mold of their invention has a transmittance of 45% or more (paragraph [0100]), which is greater than Applicant’s example 1 that has a light transmittance of 42%. Therefore, Applicant’s data fails to demonstrate unexpected results with regard to light transmittance.
As discussed above for claim 8, it would have been obvious to a person of ordinary skill in the art prior to the effective filing date to adjust the thickness through routine experimentation in order to achieve a zirconia body with the desired light transmittance properties. It has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980). Therefore, Applicant’s measured linear light transmittance is not an unexpected result.
With regard to Applicant’s asserted unexpected result for the pore count test, dipentaerythritol (polyol) used in the comparative example 4 has a higher molecular weight than glycerin used in the inventive example 1. The molecular weight of Applicant’s acrylic binder used in all samples are unknown. As such, one of ordinary skill in the art would conclude the molecular weight (i.e., size) of the polyol and binder may have a greater effect on Applicant’s results than the combustion temperature. It is well understood by one of ordinary skill in the art that when the small organic particles are burned off during the debinding phase of sintering, small pores are formed and larger organic molecules form larger pores. Therefore, one of ordinary skill in the art would expect a smaller molecule, such as glycerin polyol in Applicant’s inventive example 1, to form smaller pores (e.g., less than 50 nm) than the dipentaerythritol polyol in Applicant’s comparative example), and also would have expected the comparative example to contain a larger number of pores that are 50 nm or larger.
Furthermore, Kudo (‘573) teaches a three-point bending strength upper endpoint of 1500 MPa (paragraph [0099]) and Kudo (‘649) teaches a three-point bending strength upper endpoint of 1500 MPa (paragraph [0038]), which is greater than Applicant’s asserted unexpected result of a three-point flexural strength of 1021 MPa (Example 1). Therefore, Applicant’s assertion of unexpected results with regard to the three-point flexural strength is not persuasive.
Applicant argues, “Kudo ‘811 thus clearly does not direct one of ordinary skill in the art to the presently claimed zirconia molded body, nor does the reference acknowledge or suggest what Applicants have found in this application – that by identifying X1, Y1, X2, and Y2 as result-effective variables and arranging them in the relational formula X1 < Y1 < X2 < Y2 ≤ 500°C as in Claim 1 a zirconia molded body that provides superior and unexpected results over anything disclosed in Kudo ‘811 is obtained” (Remarks, Pg. 8).
EXAMINER’S RESPONSE: Applicant's arguments have been fully considered but they are not persuasive. Regarding a rejection of obviousness, it is not necessary for a cited reference to provide guidance or acknowledgement of relative properties (combustion start and end temperatures) that are inherent of the components (plasticizer (X) and binder (Y)) disclosed therein. As discussed above, Applicant’s claim 1 is rejected under obviousness (rather anticipation) over the cited prior art with regard to Applicant’s recited content of polyol. Applicant has failed to demonstrate the polyol content in the zirconia molded body yields a surprising or unexpected result.
Applicant argues, “Kudo ‘876 is even further removed from the present claims, as it uses, in the examples thereof, metal powder (SUS316L) whose main metal components are chromium, nickel, and molybdenum, and the disclosure only refers to ceramic powder ([0015], [0059]). Zirconia is not suggested” (Remarks, Pg. 8).
EXAMINER’S RESPONSE: Applicant's arguments have been fully considered but they are not persuasive. Applicant has misread the teachings of Kudo ‘876 (equivalent to US 2022/0153649 A1). The title, abstract, and claimed invention of Kudo ‘876 (Kudo ‘649) are drawn to a zirconium sintered body/compact. Contrary to Applicant’s assertion, all working examples a produced from a zirconia slurry (see paragraphs [0217], [0220], [0222], [0225], & [0226] of Kudo ‘649).
Kudo ‘876 does not teach the amount of polyol or binder in the zirconium sintered bodies of their invention. Therefore, the rejection over Kudo ‘876 has been withdrawn.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 NICOLE T GUGLIOTTA whose telephone number is (571)270-1552. The examiner can normally be reached M - F (9 a.m. to 10 p.m.).
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/NICOLE T GUGLIOTTA/Examiner, Art Unit 1781
/FRANK J VINEIS/Supervisory Patent Examiner, Art Unit 1781
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