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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 July 27, 2026 has been entered.
Examiner’s Note
The Examiner acknowledges the amendments of claims 1 & 3, the addition of new claims 15 – 16, the cancelation of claims 11 & 13, and the withdraw of non-elected claims 12 & 14. Claims 1 – 10 & 15 – 16 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, & 15 – 16 are rejected under 35 U.S.C. 103 as being unpatentable over Kudo (*WO 2019/026811 A1), in view of Salam et al., “Pyrolysis of poly-methyl methacrylate (PMMA) binder in thermoelectric green tapes made by the tape casting method,” Journal of the European Ceramic Society 20 (2000) 335 – 345.
*US2020/0369573 A1 is cited herein as the English language equivalent of WO 2019/0206811 A1
**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]).
Kudo (‘573) teaches examples of the binder include acrylic resin (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 acrylic binder as PVA used in the working examples and the same amount of glycerin as PEG as the polyol used in the working examples because the reference teaches the PVA and acrylic resin are functional equivalents used for the same purpose of behaving as a binder (paragraph [0072]) and 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 and temperature of 99.5% weight reduction observed of acrylic binder and polyethylene glycol, such that X1 < Y1 < X2 < Y2 ≤ 500°C.
However, with regard to X1 & X2, 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 and a combustion end temperature (X2) of 266°C.
Furthermore, Kudo (‘573) teach the binder may be an acrylic binder, but do not explicitly teach the combustion temperature range (i.e., “Y1” and “Y2”) of said acrylic binder.
Salam et al. teach polymethylmethacrylate (PMMA) (i.e., “acrylic”) binder is used in green tape casting (i.e., “a ceramic molded body”) for its low burnout (i.e., “combustion”) temperature. The PMMA binders in general leave very small amounts of char after burnout. The B-67 and the B-7MEK binders have been optimized for low char burnout by altering their chemical structures. Fig. 1 shows the bulk of weight loss (almost 85%) of acrylic binder B-67 in air combusts in the range between 214°C (Y1) and 307°C (Y2) using thermogravimetric analysis (TGA). Fig. 2 shows 80% bulk loss of acrylic Binder B-7MEK in air starts at 262.2°C (Y1) and ends at 385.8C (Y2) using TGA.
Therefore, based on the teachings of Salam et al., it would have been obvious to one of ordinary skill in the art prior to the effective filing date to use as the acrylic binder taught by Kudo ‘573 a polymethylmethacrylate binder with a low burnout (combustion) temperature that leaves very small amounts of char after burnout, such as acrylic binders B-67 or B-7MEK that have a combustion start temperature (Y1) within the combustion temperature range (X1 – X2) of the polyols taught by Kudo ‘573 and a combustion end temperature (Y2) greater than X2.
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) & Salam et al.
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)
Acrylic resin binder (¶72).
Ex.15 polyvinyl alcohol binder in amount of 2 mass% relative to the mass of zirconia (¶244).
Ex. 16 PVA & PEG 2 mass% relative to zirconia (¶246).
It would be obvious to substitute the amount of PVA binder with the same amount of acrylic resin binder.
Salam et al. teach a PMMA (acrylic) binder in Applicant’s claimed Y1-Y2 range.
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)
With regard to claims 15 – 16, as discussed above for claim 1, Kudo et al. teach the polyol is selected from polyethylene glycol or glycerin.
Claim(s) 8 is rejected under 35 U.S.C. 103 as being unpatentable over Kudo (‘573) & Salam et al., 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 July 27, 2026 is insufficient to overcome the rejection of claims 1 – 10 based upon the rejections under 35 U.S.C. 103 as set forth in the last 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, “Withdrawn Claims 12 and 14 both refer to the elected zirconia molded body of Claim 1 and thus fall within a rejoinable category. Their rejoinder is requested” (Remarks, Pg. 6).
EXAMINER’S RESPONSE: Applicant's arguments have been fully considered but they are not persuasive. The groups of the restriction requirement (mailed July 10, 2025) continue to lack unity of invention for lacking the same or corresponding special technical feature under PCT Rule 13.1 & 13.2. Therefore, the restriction requirement has been maintained.
Applicant argues, “The Office, referencing Examples 15 and 16 of Kudo, has acknowledged that ‘Kudo (‘573) fails to explicitly teach the combustion temperatures of polyvinyl alcohol and polyethylene glycol are X1 < Y1 < X2 < Y2 ≤ 500°C. Shinichi is then cited as allegedly providing a Y1 of about 100C and a Y2 of about 500C for a polyvinyl alcohol.
“As set forth in the attached second Declaration of Shinsuke Suzuki, the polyvinyl alcohol described in Shinichi does not disclose either the degree of saponification or the degree of polymerization thereof, and therefore the particular polyvinyl alcohol being discussed in Shinichi remains unidentified. It is well known to a person skilled in the art that the physical properties of a particular polyvinyl alcohol vary depending on its degree of saponification and degree of polymerization. In particular, the properties of polyvinyl alcohol vary significantly with the degree of saponification, and differences in the degree of saponification are considered to result in different thermal characteristics, including combustion start temperature and decomposition behavior. Given this, there is no reason to believed that the polyvinyl alcohol disclosed in Shinichi corresponds in any way to the polyvinyl alcohol described in Kudo” (Remarks, Pgs. 6 – 7).
EXAMINER’S RESPONSE: Applicant's arguments have been fully considered but they are not persuasive. In light of Applicant’s amendment of claim 1 reciting an acrylic binder, the previous rejection based on polyvinyl alcohol as a binder of the molded body, evidenced by Shinichi reference, is not pertinent to the current claims.
Therefore, the declaration of Shinsuke Suzuki is not pertinent to the current rejection based on the teachings of Kudo in view of Salam et al. Applicant is directed to the new rejection of the elected claims discussed above.
Applicant argues, “In addition, the above amendment to Claim 1 requires the presence of 0.01 – 10 mass % of an acrylic binder relative to 100 mass % of zirconia. This binder is not present in combination with 0.01 – 8 mass% of polyol selected from… As previous explained, and as further set forth in the attached second Declaration of Shinsuke Suzuki, the presently claimed zirconia molded body comprising this binder and this poyol in the specified mass ratio of binder:polyol of 10:1 to 1:10 and satisfying the relational formula X1 < Y1 < X2 < Y2 ≤ 500°C in combination with the specified zirconia particle is not only not disclosed or suggested by Kudo and Shinichi but also provides both surprising and unexpected results when the totality of L*, three-point flexural strength, light transmittance, linear light transmittance, pore count, and fabrication ability are considered.
“In addition, the second Declaration of Shinsuke Suzuki finds that the examples in this application are fully representative of all the zirconia molded bodies described in amended Claim 1 above, and that they evidence surprising beneficial results both in general and over anything that one of ordinary skill in the art would expect based on the disclosures in Kudo and Shinichi” (Remarks, Pg. 7).
EXAMINER’S RESPONSE: Applicant's arguments have been fully considered but they are not persuasive. First, in light of Applicant’s amendment of claim 1, a new prior art rejection has been written. Applicant is directed to the rejection above.
Second, the data presented in Applicant’s declaration filed July 27, 2026 is merely a copy of Table 3 from Applicant’s originally filed specification. Thus, Applicant’s declaration does not provide any additional data than provided in the originally filed specification. The statements in the Suzuki declaration are repetitive from the previous Suzuki declaration filed December 30, 2025.
Third, contrary to Applicant’s assertion, the data provided by Applicant is not fully representative (commensurate in scope) with amended claim 1 and/or the evidence fails to demonstrate the criticality of the claimed ranges of amended claim 1. For example:
Applicant’s claim 1 recites “a polyol selected from the group consisting of ethylene glycol, propylene glycol, diethylene glycol, 3-methyl-1,5-pentanediol, 2-methylpentane-2,4-diol, 3-methyl-1,3-butanediol, polyethylene glycol, glycerin, 1,2,3-butanediol, 1,2,4-butanediol, polyglycerin, sugars, and mixtures thereof.” However, Applicant’s originally filed specification, paragraphs [0177] – [0178], Table 1, indicate the only polyols of the working examples (inventive and comparative) were glycerin, polyethylene glycol (PEG-6000P), propylene glycol, and polyglycerin #310. In other words, Applicant does not provide data for a significant number of polyol species recited in amended claim 1.
Applicant’s evidence is based on a small number of species of acrylic binder. However, amended claim 1 only recites the large genus of “an acrylic binder.” Claim 1 does not limit the species of acrylic binder to those that were presented in Applicant’s evidence. (See Applicant’s Table 2 in paragraph [0179] of the originally filed specification.)
Applicant’s claim 1 recites 0.1 – 10 mass% binder. However, all of the samples tested only contained 0 or 2 mass% binder.
Applicant’s claim 1 recites 0.1 – 8 mass% polyol. However, the inventive samples tested only contained 1 mass% polyol and two comparative examples contained 0 or 2 mass% polyol.
Applicant’s claim 1 recites a zirconia particle comprising 2.0 – 9.0 mol% of yttria relative to the total number of moles of zirconia. However, the samples tested only contains 3 – 5 mol% yttria.
Applicant’s claim 1 recites the polyol has a combustion start temperature (X1) of 50°C or higher and 200°C or less. However, Applicant’s Table 1 indicates Applicant’s tested polyols (glycerin, polyethylene glycol, propylene glycol, and polyglycerin) had X1 values in the range of 64°C – 193°C.
The list above is not conclusive but contain just a few examples of ways in which Applicant’s evidence is insufficient for meeting the minimum standards for demonstrating unexpected results: (1) evidence commensurate in scope with the claims (See MPEP § 716.02(d)) and (2) demonstrating criticality of the claimed ranges (See MPEP § 716.02(d).II.).
Fourth, the Examiner maintains the reasons given in the remarks section of the final rejection mailed May 8, 2026 as to why Applicant’s results regarding light transmittance, pore sizes, and three-point flexural bending strength would have been expected by one of ordinary skill in the art. Therefore, Applicant’s assertion of unexpected results is not persuasive. See MPEP § 716.02(c).
Conclusion
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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