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 with traverse of Group I (claims 1 – 10) in the reply filed on July 17, 2026 is acknowledged. The traversal is on the ground(s) that Applicant asserts “the Examiner has misinterpreted the phrase ‘contribution which each of the inventions, considered as a whole, makes over the prior art’ as relating to patentable claims. While Applicant submits that their claims are patentable, at this early stage of prosecution, the claims have not been examined or rejected, nor has Applicant had a chance to respond to any rejection and/or amended their claims. It is thus incorrect to use the Examiner’s interpretation of the phrase ‘contribution which each of the inventions, considered as a whole, makes over the prior art’ as relating to decidedly patentable claims, as doing so denies Applicant due process” (Remarks, Pg. 3).
Applicant argues, “Applicant further respectfully submits that the Examiner has not provided any indication that the contents of claims interpreted in light of the description were considered in making the assertion of a lack of unity and therefore not met the burden necessary to support the assertion” (Remarks, Pg. 3).
This is not found persuasive because the Examiner explicitly cited Applicant’s specification in order to interpret Applicant’s claim for the restriction requirement under lack of unity.
Applicant argues, “Applicant respectfully submits that the Examiner has not considered the relationship of the inventions of Groups I and II with respect to 37 CFR 1.475(b)(1) and MPEP 806.03. Therefore, the burden necessary according to MPEP 1893.03(d) to sustain the conclusion that the groups lack unity of invention has not been met and the restriction requirement should be withdrawn” (Remarks, Pgs. 3 – 4).
This is not found persuasive. First, independent method claim 11 is not dependent on product claim 1. Claim 1 (Group I) also does not require the method steps of claim 11 (Group II). Therefore, contrary to Applicant’s argument, the relationship between the inventions of Groups I and II do not meet the description of “a product and process specially adapted for the manufacture of said product” under §37 CFR 1.475(b).
Second, in order for claims to have unity of invention, the claims must meet the standards of both rule 37 CFR §1.475(b) and PCT Rule 13.2. See MPEP 1893.03(d). As discussed above, Applicant’s claim 1 do have unity of invention under PCT Rule 13.2 because the claims fail to recite a special technical feature in view of the cited prior art references. Therefore, the restriction was proper for lack of unity under PCT Rule 13.2.
The requirement is still deemed proper and is therefore made FINAL.
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.
Claims 1 – 10 are 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.
Applicant’s claim 1 appears to recite the relative density of the oxide ceramic particles, but the specification suggests Applicant may have intended to recite the relative density of the pre-sintered body (see paragraph [0104] of the originally filed specification). It is assumed Applicant intended to recite the relative density of the pre-sintered body, not the relative density of the oxide ceramic particles.
Claims 2 – 10 are dependent on claim 1 and therefore also rejected.
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.
Claim(s) 1, 6, & 8 – 10 are rejected under 35 U.S.C. 103 as being unpatentable over Schechner et al. (US 2013/0341812 A1), in view of Kudo et al. (WO 2021/100876 A1).
With regards to claim 1, Schechner et al. teach a dental ceramic formed from a pre-sintered ceramic article (paragraph [0035]) comprising zirconia and alumina (ceramic oxides) (“i.e., primary particles”), wherein the pre-sintered ceramic article is characterized by a porosity form about 40 – 60 vol% (paragraphs [0083] – [0086]).
Applicant’s specification, paragraph [0136], teaches the relative density of the sintered body was calculated as follows:
[0136]: The relative density was calculated from the measured porosity, using the following formula.
(Relative density) (%) = {1 - (porosity)} x 100
Therefore, the relative density of the pre-sintered ceramic article taught by Schechner et al. in the range of 1 – [0.40 – 0.60] x 100 = 40 – 60%, which overlaps with Applicant’s claimed range of 43 to 63%.
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).
Schechner et al. do not teach the average roundness of the primary particles.
Kedo et al. teach a zirconia calcined (i.e., “pre-sintered”) body comprising zirconia, preferably as primary particles (i.e., spherical particles having the smallest unit) (pgs. 4 – 5) that have a high degree of sphericity for allowing mixing at the interface between layers when zirconia powders with different compositions are laminated. The higher the sphericity, the higher the packing density. The sphericity of the granules is represented by the circularity. The average circularity of the granules in the zirconia composition is preferably 0.81 or more (pgs. 5 – 6).
Therefore, based on the teachings of Kedo et al., it would have been obvious to one of ordinary skill in the art prior to the effective filing date to form the primary particles taught by Schechner et al. with an average circularity/sphericity (roundness) of 0.81 or more for achieving a calcined body with a high packing density.
With regards to claim 6, as discussed above for claim 1, Schechner et al. teach the oxide ceramic particles comprise zirconia and/or alumina.
With regards to claim 8, Schechner et al. teach the ceramic article may comprise stabilizers (i.e., “sintering aids”), such as Ca, Mg (Group 2 elements,) Ce, or Y (paragraphs [0068] – [0069]).
With regard to claims 9 – 10, Schechner et al. do not teach the ceramic body has a surface roughness Ra of 1.40 µm or less after being fired into a sintered body under atmospheric pressure without a hot isostatic pressing process and do not teach the ceramic body has a has a surface roughness Rz of 51 µm or less after being fired into a sintered body under atmospheric pressure without a hot isostatic pressing process.
However, the elected independent claim 1 and dependent claims 9 – 10 are drawn to a pre-sintered ceramic body, not a sintered body. Therefore, the recited sintering treatment and properties resulting from said treatment are considered matters of intended use. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In the current case, the pre-sintered ceramic body taught by Schechner et al. is capable of being sintered under atmospheric pressure without a hot isostatic pressing process and have a surface roughness Ra of 1.40 µm or less and a surface roughness Rz of 51 µm or less.
Claim(s) 2 – 3 are rejected under 35 U.S.C. 103 as being unpatentable over Schechner et al. & Kudo et al., as applied to claim 1 above, and further in view of Yamada et al. (US 2016/0074142 A1).
With regards to claim 2, Schechner et al. do not teach the average particle diameter of the primary particles.
Yamada et al. teach a zirconia pre-sintered body for use in a dental prosthesis, wherein the comprising a pulverized primary particle, such as zirconia powder, has an average particle size of 0.13 µm (i.e., 130 nm) (paragraph [0130]).
Therefore, based on the teachings of Yamada et al., it would have been obvious to one of ordinary skill in the art prior to the effective filing date to form a pre-sintered body for use in dental prosthesis, wherein the body comprises primary particles that have an average particle size of 130 nm, which within Applicant’s claimed range of 30 to 600 nm. The Supreme Court has held that is obvious to apply a known technique to a known device ready for improvement to yield predictable results. KSR, 550 U.S. at 415-21, 82 USPQ2d at 1395-97. See MPEP 2141.III. and 2143. In the current case, it would have been obvious to one of ordinary skill in the art prior to the effective filing date apply the known technique of using zirconia particles of a particular average diameter to a known device, such as a dental prosthesis, for improvement to yield predictable results.
With regards to claim 3, Schechner et al. do not explicitly teach the three-point flexural strength of the pre-sintered body.
Yamada et al. teach a pre-sintered zirconia body for use as a dental prosthetic that has a three-point flexural strength of not less than 38 MPa (paragraphs [0071] & [0103]). The flexural strength may be achieved by adjusting the content of stabilizer (i.e., sintering aid) (paragraph [0061]).
Therefore, based on the teachings of Yamada et al., it would have been obvious to one of ordinary skill in the art prior to the effective filing date to form a pre-sintered zirconia body used as a dental prosthetic that has a three-point flexural of at least 38 MPa, which overlaps with Applicant’s claimed range of 10 – 50 MPa. 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).
Claim(s) 5 is rejected under 35 U.S.C. 103 as being unpatentable over Schechner et al. & Kudo et al., as applied to claim 1 above, and further in view of Feith (US 2010/0119994 A1).
With regards to claim 5, Schechner et al. do not teach the pre-sintered ceramic body has a has a surface roughness Rz of 54 µm or less after polishing.
Feith teaches an artificial dental prosthesis, wherein there is a need for adequate surface roughness via roughening of a portion of the green compact (pre-sintered body) (paragraph [0068]). In order to improve the integration of the anchoring part 30 of the prosthesis, the outer surface of the subgingival section has a particular roughness - the average roughness value, Rz, is between 15 and 30 µm (paragraph [0065]). The higher the roughness of the outer surface increases the osteointegration and thus secure the dental implant in the bone (paragraph [0036]).
Therefore, based on the teachings of Feith, it would have been obvious to one of ordinary skill in the art prior to the effective filing date to form the pre-sintered ceramic body taught by Schechner et al. with an average surface roughness Rz between 8 and 30 um, which is within Applicant’s claimed range of 54 µm or less, in order improve osteointegration (i.e., secure the dental prosthesis into the bone).
Feith does not explicitly teach the surface roughness Ra or Rz of the pre-sintered ceramic were achieved after a polishing treatment.
However, claims 4 – 5 define the product by how the product was made. Thus, claims 4 – 5 are product-by-process claims. 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 pre-sintered ceramic body having a particular surface roughness (Ra, Rz). The reference suggests such a product.
Examiner refers applicant to MPEP § 2113 [R - 1] regarding product-by-process claims. “The patentability of a product does not depend on its method or production. If the product in the product-by-process claim is the same as or obvious from a product or the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777, F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citation omitted)
Once the examiner provides a rationale tending to show that the claimed product appears to be same or similar to that of the prior art, although produced by a different process, the burden shifts to the applicant to come forward with evidence establishing an unobvious difference between the claimed product and the prior art product. In re Marosi, 710 F.2d 798, 802, 218, USPQ 289, 292 (Fed. Cir. 1983)
Claim(s) 7 is rejected under 35 U.S.C. 103 as being unpatentable over Schechner et al. & Kudo et al., as applied to claim 1 above, and further in view of Watanabe et al. (U.S. Patent No. 6,306,788 B1).
With regards to claim 7, Schechner et al. do not teach the alumina comprises alpha-alumina particles with a purity of 99.5% or more.
Watanabe et al. teach a sintered ceramic body comprising alpha-alumina primary particles. The alpha-alumina is a single particle powder in which the primary particle is homogeneous, has no defect inside, has polyhedral form and a D/H ratio of from 0.5 or more to 3.0 or less and the primary particles does not coagulate each other, as well as a purity of the powder of 99.99% or more. When this alpha-alumina is used as a raw material, there can be obtained a formed product in which particle arrangement is uniform and cavity size between particles is uniform due to sharp particle size distribution (Col. 2, Lines 53 – 62).
Therefore, based on the teachings of Watanabe et al., it would have been obvious to one of ordinary skill in the art prior to the effective filing date to use alpha--alumina with a purity of 99.99% or more as the primary aluminum oxide particles of the pre-sintered ceramic article by Schechner et al. because alpha-particles form a uniform particle arrangement in the ceramic article.
Claim(s) 4 & 9 – 10 are rejected under 35 U.S.C. 103 as being unpatentable over Schechner et al. & Kudo et al., as applied to claim 1 above, and further in view of Ghosh et al. (US 2005/0261795 A1).
With regard to claim 4, Schechner et al. do not teach the pre-sintered body has a surface roughness Ra of 1.70 µm or less after polishing.
With regards to claim 9, Schechner et al. do not teach the ceramic body has a surface roughness Ra of 1.40 µm or less after being fired into a sintered body under atmospheric pressure without a hot isostatic pressing process.
With regards to claim 10, Schechner et al. do not teach the ceramic body has a has a surface roughness Rz of 51 µm or less after being fired into a sintered body under atmospheric pressure without a hot isostatic pressing process.
Ghosh et al. teach a method of making ceramic dental restorations, wherein a brown ceramic blank (i.e., “pre-sintered ceramic”) restoration has a surface roughness (Ra) after milling (i.e., “polishing”) in the range of 1.0 – 2.0 µm, more preferably 1.2 µm (paragraph [0067]) and the sintered ceramic restoration preferably has an average surface roughness (Ra) of 0.4 – 0.8 µm and a mean roughness depth (Rz) of 2.7 – 4.3 µm (paragraphs [0062] – [0063] & [0068]). The desired surface roughness was obtained by microwave sintering (paragraphs [0032] & [0051]), cosmetic polishing (paragraph [0057]). Ghost et al. is silent with regard to the pressure and hot isostatic pressing during the sintering process. One of ordinary skill in the art would assume a given method step is conducted at atmospheric pressure when a reference is silent with regard to pressure.
Therefore, based on the teachings of Ghost et al., it would have been obvious to one of ordinary skill in the art to form the pre-sintered ceramic article taught by Schechner et al. with an average surface roughness (Ra) of 1.0 – 2.0 µm, preferably 1.2 µm, and a sintered ceramic article taught by Schechner et al. with an average surface roughness (Ra) of 0.4 – 8 µm and a mean roughness depth (Rz) of 2.7 – 4.3 µm for desired use in dental restorations, and to form such ceramic article by sintering and polishing, without the treatment of pressure (i.e., atmospheric pressure) or hot isostatic pressing during sintering.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Frank Vineis can be reached at 571-270-1547. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NICOLE T GUGLIOTTA/Examiner, Art Unit 1781
/FRANK J VINEIS/Supervisory Patent Examiner, Art Unit 1781
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