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 .
Information Disclosure Statement
The information disclosure statement filed February 10, 2023 fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because the information disclosure statement does not include proper identification for all cited references. Specifically, for item number 14, the patent number does agree with the issue date and the inventor name. The information disclosure statement has been placed in the application file, but the information referred to therein has not been considered as to the merits. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
Claim Interpretation
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art.
The transitional phrase “including” in claim 1 and in claim 6, along with the form “includes” in claims 2 and 7, is treated as indicating that an open construction is intended, such that “including” is read as roughly equivalent to “comprising” for purposes of claim interpretation, such a construction appearing to be the broadest reasonable interpretation in view of Applicant’s Specification (see Specification at ¶¶ 0015-0017, and claim 9; see also MPEP 2111.03(IV)).
The phrase “no substantial amount of free MgO” in claim 8 is interpreted as meaning “less than 0.5% free MgO” (see Specification at p. 11, ¶ 0031). Likewise, the phrase “no substantial amount of free CaO” in claims 12 and 15 is interpreted as meaning “less than 0.5% free CaO” (see Specification at p. 11, ¶ 0031).
Claim Objections
Claims 5, 8, 12, and 15 are objected to because of the following informalities: these claims recite “zirconia microstructure” (without a definite article), whereas claims 1, 2, 4, and 14 recite “the zirconia microstructure.” 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.
Claims 1-15 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.
The term “largely” in line 7 of claim 1 and in line 14 of claim 14 is a relative term which renders the claim indefinite. The term “largely” is not defined by the claim, the specification does not provide a definite standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claims 2-13 are rejected by reason of their dependence from claim 1. Claim 15 is rejected by reason of its dependence from claim 14.
For purposes of claim interpretation, “largely free of monoclinic content” will be treated as if reciting “comprising less than 15% by volume of monoclinic content,” this appearing to be the broadest reasonable interpretation consistent with the Specification (see p. 5, ¶ 0015, and see Table on p. 15).
In claim 12, the limitation “the sintered PSZ body is prepared from a PSZ powder” renders the claim indefinite, since it is not clear whether “a PSZ powder” in line 2 of claim 12 is the same PSZ powder previously introduced in line 3 of independent claim 1 (from which claim 12 depends). Moreover, if the “PSZ powder” in line 2 of claim 12 is the same PSZ powder as in claim 1, then it is not clear what patentable weight the limitation “the sintered PSZ body is prepared from a PSZ powder” adds over and above the limitation in line 6 of claim 1.
Additionally, the phrase “pre-stabilized PSZ” in line 2 of claim 12 renders the claim indefinite, as the term “pre-stabilized” is not defined in the claim, the Specification offers no guidance as to the meaning of the term, and it is unclear how, if at all, “pre-stabilized PSZ” is different from “pre-alloyed PSZ” (as used in claim 1 and multiple other claims).
For purposes of claim interpretation, claim 12 will be treated as if reciting that the pre-alloyed PSZ powder includes CaO as the oxide stabilizing agent.
Similarly, in claim 15, the limitation “the sintered PSZ body is prepared from a PSZ powder” in line 2 renders the claim indefinite, since it is not clear whether “a PSZ powder” in line 2 of claim 15 is the same PSZ powder previously introduced in line 4 of independent claim 14 (from which claim 15 depends). Moreover, if the “PSZ powder” in line 2 of claim 15 is the same PSZ powder as in claim 14, then it is not clear what patentable weight the limitation “the sintered PSZ body is prepared from a PSZ powder” adds over and above claim 14.
Additionally, the phrase “pre-stabilized PSZ” in line 3 of claim 15 renders the claim indefinite, as the term “pre-stabilized” is not defined in the claim, the Specification offers no guidance as to the meaning of the term, and it is unclear how, if at all, “pre-stabilized PSZ” is different from “pre-alloyed PSZ” (as used in claim 14).
For purposes of claim interpretation, claim 15 will be treated as if reciting that the pre-alloyed PSZ powder includes CaO as the oxide stabilizing agent.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-4, 6, and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by EP 0131774 B1 to Knapp (hereinafter “Knapp”).
Regarding claim 1, Knapp discloses a method for producing toughened zirconia materials (Col. 1, lines 23-29) including processing zirconia and an oxide stabilizing agent to produce a partially stabilized zirconia (PSZ) powder (Col. 1, lines 39-43), where the oxide stabilizing agent is dissolved into the zirconia microstructure (“co-fused,” Col. 1, line 41), resulting in a pre-alloyed PSZ powder (Col. 1, lines 24-26). Knapp further discloses wherein the method includes using the pre-alloyed PSZ powder to produce a sintered PSZ body, made of the pre-alloyed PSZ powder (Col. 1, lines 43-44). Knapp teaches wherein the sintered PSZ body remains stabilized and exhibits tetragonal crystal phase (Col. 1, line 61—Col. 2, line 2, and Col. 2, lines 32-35); thus, the sintered PSZ body remains largely free of monoclinic content.
Regarding claim 2, Knapp teaches wherein the step of processing zirconia and an oxide stabilizing agent to produce a pre-alloyed PSZ powder includes mixing the zirconia and the oxide stabilizing agent to prepare a mixture of a desired composition (Col. 1, lines 55-56) and treating the prepared mixture to elicit the reaction or dissolution of the oxide stabilizing agent into the zirconia microstructure (melting followed by rapid quenching, see Col. 1, lines 39-42 and Col. 2, lines 12-22), resulting in a pre-alloyed PSZ material (Col. 1, lines 24-27).
Regarding claim 3, Knapp teaches wherein the step of treating the prepared mixture is a thermal based operation (melting followed by rapid quenching, see Col. 1, lines 39-42 and Col. 2, lines 12-22).
Regarding claim 4, Knapp teaches wherein the step of treating the prepared mixture heats the mixture to melt both constituents and induce integration of the oxide stabilizing agent into the zirconia microstructure (see Col. 1, lines 39-42 and Col. 2, lines 12-22).
Regarding claim 6, Knapp teaches wherein, in some embodiments, the pre-alloyed PSZ material includes “some smaller amount of monoclinic zirconia” (Col. 2, line 25), implicitly indicating that the raw materials include monoclinic zirconia. Knapp teaches wherein the method according to claim 1 further includes selecting raw materials that include an oxide stabilizing agent source including MgO (Col. 2, line 5; claim 2).
Regarding claim 12, Knapp teaches the method according to claim 1, wherein the sintered PSZ body is prepared from a pre-alloyed PSZ powder including CaO as the oxide stabilizing agent, which is reacted or dissolved in the zirconia microstructure (see Col. 2, line 4; claim 2). Although Knapp does not explicitly teach that the pre-alloyed PSZ powder includes no substantial amount of free CaO, given the substantial similarity between the claimed invention and the method for producing toughened zirconia materials taught by Knapp, one of ordinary skill in the art reasonably would expect that pre-alloyed PSZ powder produced by the method of Knapp likewise includes no substantial amount of free CaO. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established (see MPEP 2112.01(I), first paragraph).
Claim(s) 1-3, 5-6 and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mustafa et al., “Phase stability and microstructural characteristics of 12 mol% (Mg, Ca)-PSZ prepared via polymeric route,” Ceramics International 29(2) [2003], pp. 189-194 (hereinafter “Mustafa”).
Regarding claim 1, Mustafa teaches a method for producing toughened zirconia materials (Abstract) including processing zirconia and an oxide stabilizing agent to produce a partially stabilized zirconia (PSZ) powder (p. 190), where the oxide stabilizing agent is dissolved into the zirconia microstructure (p. 191, col. 1, discussing “dissociation reaction” whereby CaO and/or MgO oxide stabilizing agent is dissolved into zirconia solid solutions), resulting in a pre-alloyed PSZ powder (p. 191, col. 1). Mustafa further discloses wherein the method includes using the pre-alloyed PSZ powder to produce a sintered PSZ body, made of the pre-alloyed PSZ powder (p. 190, col. 2, subsection 2.4). Mustafa teaches wherein the sintered PSZ body remains stabilized and largely free of monoclinic content (see p. 191, col. 2, teaching that in “MgO-containing mixes Z8, Z9 and Z10, the stability of tetragonal zirconia increased and the amount of monoclinic zirconia decreased to less than 10%”; see also p. 192, Fig. 5, showing that XRD analysis of samples Z9 and Z10 showed almost no residual peaks associated with monoclinic crystal phase).
Regarding claim 2, Mustafa teaches wherein the step of processing zirconia and an oxide stabilizing agent to produce a pre-alloyed PSZ powder includes mixing the zirconia and the oxide stabilizing agent to prepare a mixture of a desired composition (p. 190, subsection 2.2, Fig. 1, Table 1) and treating the prepared mixture to elicit the reaction or dissolution of the oxide stabilizing agent into the zirconia microstructure (p. 190, subsection 2.2, Fig. 1), resulting in a pre-alloyed PSZ material (p. 190, subsection 2.3).
Regarding claim 3, Mustafa teaches wherein the step of treating the prepared mixture is a thermal or chemical based operation (p. 190, subsections 2.2-2.3, teaching preparation of pre-alloyed PSZ powder by a polymerization reaction to form polymer resin, following by thermal operations including calcining at 600°C).
Regarding claim 5, Mustafa teaches wherein the step of treating the prepared mixture chemically reacts the zirconia-stabilizing oxide mixture to induce integration of the oxide stabilizing agent into the zirconia microstructure (p. 190, subsection 2.2, teaching preparation of pre-alloyed PSZ powder by a polymerization reaction to form polymer resin gels integrating the Zr cations and the cations of the oxide stabilizing agent).
Regarding claim 6, Mustafa teaches the method according to claim 1 further including selecting raw materials from a zirconia source including zirconium chemicals (zirconium oxychloride, p. 190, subsection 2.1).
Regarding claim 12, Mustafa teaches wherein the sintered PSZ body is prepared from a PSZ powder (p. 190, subsection 2.4) and wherein the powder is pre-alloyed PSZ powder using CaO as the oxide stabilizing agent (see p. 190, Table 1), which is reacted or dissolved in the zirconia microstructure (p. 191, col. 1). Mustafa teaches wherein the pre-alloyed PSZ powder includes no substantial amount of free CaO (see p. 192, Fig. 5, showing no XRD peaks associated with free CaO).
Claim Rejections - 35 USC § 103
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.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Pat. Pub. 2012/0292832 to Serafin et al. (hereinafter “Serafin”) in view of either Knapp or Mustafa.
Regarding claim 7, Serafin teaches a method for producing a ceramic body prosthetic implant or prosthetic implant component (Abstract). Serafin teaches that the process includes using a zirconia powder to produce a sintered PSZ body (see ¶¶ 0085, 0095).
However, Serafin does not teach that the process for producing a ceramic body prosthetic implant or prosthetic implant component includes processing zirconia and an oxide stabilizing agent materials to produce a pre-alloyed partially stabilized zirconia (PSZ) powder, according to the method according to claim 1.
Knapp, in a closely related field of endeavor (processes for producing partially stabilized zirconia ceramics), discloses the method for producing toughened zirconia materials according to claim 1, as set forth above (see p. 6). Mustafa, in a closely related field of endeavor (processes for producing partially stabilized zirconia ceramics), discloses the method for producing toughened zirconia materials according to claim 1, as set forth above (see p. 8).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Serafin by substituting, for the step in Serafin of introducing a zirconia powder, a step of processing zirconia and an oxide stabilizing agent to produce a pre-alloyed PSZ powder, as taught by Knapp or Mustafa. Design incentives, such as the desire for a strong material to be used in a ceramic body prosthetic implant or prosthetic implant component (see Serafin at ¶¶ 0003, 0014), would prompt one of ordinary skill in the art to look to references like Knapp and Mustafa for stronger variations on the partially stabilized zirconia used in Serafin and for methods of providing those stronger variations of partially stabilized zirconia used in Serafin’s method (see Knapp at Col. 3, lines 34-42; Mustafa at p. 194). One of ordinary skill in the art would have been able to incorporate the method steps taught by Knapp or Mustafa into the Serafin method (i.e., substituting pre-alloyed PSZ powder, as taught by Knapp or Mustafa, for the zirconia powder in Serafin), with predictable results and a high probability of success. See MPEP 2143(I)(F).
Thus, in view of Serafin as modified by Knapp or Mustafa, a method comprising every limitation of claim 7 would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Claims 8-11 and 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Serafin in view of Mustafa.
Regarding claim 8, Serafin as modified by Mustafa teaches the method according to claim 7, as set forth above (see p. 11). Further, Serafin as modified by Mustafa teaches wherein the oxide stabilizing agent is MgO (see Serafin at ¶ 0085; see Mustafa at p. 190, Table 1) and is reacted or dissolved in the zirconia microstructure, with no substantial amount of free MgO remaining (see Mustafa at p. 192, Fig. 5, showing no XRD peaks associated with free MgO).
Regarding claim 9, Serafin as modified by Mustafa teaches the method according to claim 8, as set forth above. Further, Serafin as modified by Mustafa teaches wherein the sintered PSZ body comprises a ceramic body prosthetic implant or prosthetic implant component of Mg-PSZ ceramic (see Serafin at ¶ 0087).
Regarding claim 10, Serafin as modified by Mustafa teaches the method according to claim 8, as set forth above. Further, Serafin as modified by Mustafa teaches wherein the sintered PSZ body is formed using cold isostatic pressing (see Serafin at Abstract).
Regarding claim 11, Serafin as modified by Mustafa teaches the method according to claim 10, as set forth above. Further, Serafin as modified by Mustafa teaches wherein an initial green body made from the pre-alloyed PSZ powder is machined to near final shape, or the body is bisque fired and then machined, with the machined body then being fired using a PSZ sintering cycle (see Serafin at ¶¶ 0099, 0118).
Regarding claim 13, Serafin teaches a biomedical implant made from magnesium oxide stabilized transformation toughened zirconia (i.e., partially stabilized zirconia) (Abstract). However, Serafin does not teach that the biomedical implant is made from pre-alloyed PSZ powder produced in accordance with the method of claim 1.
Mustafa teaches a sintered PSZ body made from pre-alloyed PSZ powder produced in accordance with the method of claim 1, as set forth above (see p. 8).
It would have been obvious to one of ordinary skill in the art to modify the biomedical implant of Serafin by substituting, for the magnesium oxide stabilized transformation toughened zirconia of Serafin, the pre-alloyed PSZ powder taught by Mustafa. Design incentives, such as the desire for a strong material to be used in biomedical implant (see Serafin at ¶¶ 0003, 0014), would prompt one of ordinary skill in the art to look to art like Mustafa for stronger variations on the partially stabilized zirconia used in Serafin (see Mustafa at p. 194). One of ordinary skill in the art would have been able to incorporate pre-alloyed PSZ powder as taught by Mustafa for the zirconia powder in Serafin, with predictable results and a high probability of success. See MPEP 2143(I)(F).
Regarding claim 14, Serafin teaches a partially stabilized zirconia material, including the step of producing a ceramic body prosthetic implant or prosthetic implant component (Abstract).
However, Serafin does not teach wherein the partially stabilized zirconia material produced in accordance with a method that includes processing zirconia and an oxide stabilizing agent materials to produce a partially stabilized zirconia (PSZ) powder, where the oxide stabilizing agent is dissolved into the zirconia microstructure, resulting in a pre-alloyed PSZ powder, and wherein the step of processing zirconia and an oxide stabilizing agent to produce a pre-alloyed PSZ powder includes mixing the zirconia and the oxide stabilizing agent to prepare a mixture of a desired composition and treating the prepared mixture to elicit the reaction or dissolution of the oxide stabilizing agent into the zirconia microstructure, resulting in a pre-alloyed PSZ material, and using the pre-alloyed PSZ powder, producing a sintered PSZ body, made of the pre-alloyed PSZ powder, which remains stabilized and largely free of monoclinic content.
Mustafa teaches Mustafa teaches a method for producing toughened zirconia materials (Abstract) including processing zirconia and an oxide stabilizing agent to produce a partially stabilized zirconia (PSZ) powder (p. 190), where the oxide stabilizing agent is dissolved into the zirconia microstructure (p. 191, col. 1, discussing “dissociation reaction” whereby CaO and/or MgO oxide stabilizing agent is dissolved into zirconia solid solutions), resulting in a pre-alloyed PSZ powder (p. 191, col. 1). Mustafa teaches wherein the step of processing zirconia and an oxide stabilizing agent to produce a pre-alloyed PSZ powder includes mixing the zirconia and the oxide stabilizing agent to prepare a mixture of a desired composition (p. 190, subsection 2.2, Fig. 1, Table 1) and treating the prepared mixture to elicit the reaction or dissolution of the oxide stabilizing agent into the zirconia microstructure (p. 190, subsection 2.2, Fig. 1), resulting in a pre-alloyed PSZ material (p. 190, subsection 2.3). Mustafa further teaches using the pre-alloyed PSZ powder to produce a sintered PSZ body, made of the pre-alloyed PSZ powder (p. 190, col. 2, subsection 2.4). Mustafa teaches wherein the sintered PSZ body remains stabilized and largely free of monoclinic content (see p. 191, col. 2, teaching that in “MgO-containing mixes Z8, Z9 and Z10, the stability of tetragonal zirconia increased and the amount of monoclinic zirconia decreased to less than 10%”; see also p. 192, Fig. 5, showing that XRD analysis of samples Z9 and Z10 showed almost no residual peaks associated with monoclinic crystal phase).
It would have been obvious to one of ordinary skill in the art to modify the prosthetic implant or prosthetic implant component of Serafin by substituting, for the magnesium oxide stabilized transformation toughened zirconia of Serafin, the pre-alloyed PSZ powder taught by Mustafa. Design incentives, such as the desire for a strong material to be used in prosthetic implant or prosthetic implant component (see Serafin at ¶¶ 0003, 0014), would prompt one of ordinary skill in the art to look to art like Mustafa for stronger variations on the partially stabilized zirconia used in Serafin (see Mustafa at p. 194). One of ordinary skill in the art would have been able to incorporate pre-alloyed PSZ powder as taught by Mustafa for the zirconia powder in Serafin, with predictable results and a high probability of success. See MPEP 2143(I)(F).
Thus, in view of Serafin as modified by Mustafa, a material meeting all of the limitations of claim 14 would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Regarding claim 15, Serafin as modified by Mustafa teaches the material produced in accordance with the method of claim 14, and Serafin as modified by Mustafa further teaches wherein the sintered PSZ body is prepared from a PSZ powder (see Mustafa at p. 190, subsection 2.4) and wherein the powder is pre-alloyed PSZ powder using CaO as the oxide stabilizing agent (see Mustafa at p. 190, Table 1), which is reacted or dissolved in the zirconia microstructure (Mustafa at p. 191, col. 1). Serafin as modified by Mustafa teaches wherein the pre-alloyed PSZ powder includes no substantial amount of free CaO (see Mustafa at p. 192, Fig. 5, showing no XRD peaks associated with free CaO).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
U.S. Pat. Pub. 2021/0171402 to Okamura et al. (hereinafter “Okamura”) teaches sintered material includes a cubic boron nitride, a zirconium-containing oxide, a zirconium-containing nitride, and an aluminum-containing oxide (Abstract). Okamura teaches that the zirconium-containing oxide preferably comprises cubic ZrO2 more preferably consists of partially stabilized ZrO2 (¶ 0035). Okamura teaches wherein the partially stabilized zirconia is stabilized by calcium oxide and/or magnesium oxide (¶ 0034).
Pavlyuchkov et al., “Experimental Investigation and Thermodynamic Modeling of the ZrO2–MgO System,” Adv. Eng. Mater., 15 (2013), pp. 618-626 (hereinafter “Pavlyuchkov”) teaches partially stabilized zirconia with various MgO concentrations (p. 618). Pavlyuchkov discloses a sintered body produced from pre-alloyed partially stabilized zirconia with 12 mol.% MgO which exhibits only 4 vol.% monoclinic crystal phase and substantially no free MgO (see p. 621, Table 2, Sample Mg-PSZ-4).
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/P.A.F./Examiner, Art Unit 1731
/JENNIFER A SMITH/Primary Patent Examiner, Art Unit 1731