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 .
Detailed Action
Previous Rejections
Applicants' arguments, filed 11/03/25, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Upon further consideration, the finality of the previous office action has been withdrawn and new rejections have been made in this office action. Therefore, this action is Non-final.
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.
Claims 39-43, 46-51 and 59-60 are rejected under 35 U.S.C. 103 as being unpatentable over Zhongping Yao et al. (“Effect of Na2S0O4 on Structure and Corrosion Resistance of Ceramics Coatings Containing Zirconium Oxide on Ti-GAI-4V Alloy", JOURNAL OF THE AMERICAN CERAMIC SOCIETY., vol. 89, no. 9, 12 June 2006 (2006-06-12), pages 2929-2932, presented in IDS) in view of Jerome Chevalier et al. ( "The Tetragonal-Monoclinic Transformation in Zirconia: Lessons Learned and Future Trends", JOURNAL OF THE AMERICAN CERAMIC SOCIETY, vol. 92, no. 9, 1 September 2009 (2009-09-01), pages 1901-1920, presented in IDS) and Trolliard et al. ("Pure orthorhombic zirconia islands grown on single- crystal sapphire substrates", ACTA MATERIALIA, ELSEVIER, OXFORD, GB, vol. 55, no. 17, 21 September 2007 (2007-09-21), pages 6011-6018, presented in IDS) and Anderson et al. (US PG Pub. 2010/0131062A1) in view of Malshe et al. (US PG Pub. 2012/0276336A1).
Zhongping et al. discloses a biomedical implant comprising a Ti-6Al-4V substrate (Ti-6AI-4V) which is a titanium alloy used in medicine to manufacture implantable devices as orthopedic prosthesis, tooth implants and stents, coated by micro-plasma oxidation (i.e. by electro plasma oxidation), see (abstract; sections "I." "l.1" and "IL2 and 3"; figure 2; Figure 4). The coating comprises monoclinic ZrO2, and KZr2(PO4)3. Comparing Figure 2 of Zhongping et. al with Figure 5 of the instant application, it appears that the peaks marked with an empty square in the reference correspond to the peaks marked "O" in the present application. Therefore, the peaks interpreted as orthorhombic zirconia in the present application, are attributed to tetragonal zirconia in the reference. The coating has a thickness of 94 or 206 micrometers. While the coatings are different in dimensions in the reference, the skilled person would have considered providing different coating thicknesses, in particular there would be no technical challenge in providing thinner thicknesses due to the method used, it would be sufficient to perform the process for shorter time. The methods listed are examples of known methods used in the art that the skilled person would have selected based on common general knowledge. The coating taught in the reference does not have a uniform composition from the substrate to top of the coating and can be divided in 3 portions, an inner portion rich in Ti and poor in Zr; an intermediate zone richer in Zr and poorer in Ti; and an outer zone, poorer in Titanium and Zirconium and more porous. It appears that the signals defined as belonging to orthorhombic zirconia in figure 5 of the present application, are, in reality, signals belonging to the tetragonal phase (see e.g. Zhongping et al., figure 2, showing a sample obtained under conditions comparable to the sample tested in the present application).
The reference does not teach the exact monoclinic or orthorhombic phases of zirconium oxide, however from the figure it appears similar and the reference suggests that implants are made of ceramic coatings. Therefore, it would be obvious to one of ordinary skill to have an implant comprising zirconium oxide of specific phase and for coating purposes.
However, Chevalier et al. teaches that zirconia usually exists in 3 allotropes monoclinic, tetragonal and cubic. Monoclinic form is stable up to 1170 °C where it transforms to tetragonal and then cubic at temperatures above 2370 °C (see, abstract; Section II, 2nd paragraph; figure A1). It is also taught that “zirconia ceramics have found broad applications in a variety of energy and biomedical applications because of their unusual combination of strength, fracture toughness, ionic conductivity, and low thermal conductivity. These attractive characteristics are largely associated with the stabilization of the tetragonal and cubic phases through alloying with aliovalent ions. The large concentration of vacancies introduced to charge compensate of the aliovalent alloying is responsible for both the exceptionally high ionic conductivity and the unusually low, and temperature independent, thermal conductivity. The high fracture toughness exhibited by many of zirconia ceramics is attributed to the constraint of the tetragonal-to-monoclinic phase transformation and its release during crack propagation. In other zirconia ceramics containing the tetragonal phase, the high fracture toughness is associated with ferroelastic domain switching. However, many of these attractive features of zirconia, especially fracture toughness and strength, are compromised after prolonged exposure to water vapor at intermediate temperatures (~ 30°-300°C) in a process referred to as low-temperature degradation (G.TD), and initially identified over two decades ago. This is particularly so for zirconia in biomedical applications, such as hip implants and dental restorations. Less well substantiated is the possibility that the same process can also occur in zirconia used in other applications, for instance, zirconia thermal barrier coatings after long exposure at high temperature. Based on experience with the failure of zirconia femoral heads, as well as studies of LTD, it is shows that many of the problems of LTD can be mitigated by the appropriate choice of alloying and/or process control, see abstract.
Trolliard et al. teaches that orthorhombic zirconia is described in literature, but it is a form which requires either high pressure (e.g. above 3.5 GPa) to transform monoclinic zirconia into orthorhombic zirconia; specific dopants; or specific substrates (see, section 1, first paragraph and section 5).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have utilized either tetragonal, monoclinic or orthorhombic phases of zirconium oxide as taught by Chevelier and Trolliard et al. into the zirconium coated coating materials of Zhongping et al. One of ordinary skill would have been motivated to do so because Chevelier teaches that “zirconia ceramics have found broad applications in a variety of energy and biomedical applications because of their unusual combination of strength, fracture toughness, ionic conductivity, and low thermal conductivity. These attractive characteristics are largely associated with the stabilization of the tetragonal and cubic phases through alloying with aliovalent ions. And Trolliard provides guidance to make orthorhombic zirconium oxide by teaching that orthorhombic zirconia is described in literature, but it is a form which requires either high pressure to transform monoclinic zirconia into orthorhombic zirconia; specific dopants; or specific substrates (see, section 1, first paragraph and section 5).
The references discussed above do not teach the average grain-size of the coating as claimed.
Andersson et al teaches a method of applying crystalline nanoparticles onto the surface of an implant to produce an implant with a crystalline nanoparticle layer on the surface of implant. The nanoparticle application is designed to control the thickness and uniformity of the nanoparticle layer, while simultaneously retaining the microroughness of the implant, see title and abstract. Anderson teaches that the implant body can comprise zirconium oxide and metals such as zirconium, titanium and aluminum, see [0060]. The implants are used in medical use such as joint, dental and for human and veterinary use, see [0059]. The exemplary crystalline nanoparticles include zirconium oxide, and calcium phosphate, tetracalcium phosphate or tricalcium phosphate nanoparticles and combinations thereof, see [0061]. The nanoparticles are in dispersion, dry form or non-dry form, see [0063]. The reference teaches calcium phosphate nanocrystals in the range of from about 20nm to about 100nm, see [0069].
Malshe et al. teaches a hydroxyapatite coating for dental and orthopedic implant, see title. The reference teaches that zinc oxide nanoparticles may be incorporated to form nanoparticles coating material for its intrinsic antimicrobial property, see abstract. The reference teaches coating to be nanocrystalline in nature and ranging from grain size from 50 to 300nm, see [0010] and [0045]. The reference teaches that the resulting coating is micro-patterned and has inter-connected nanopores, and is believed to offer osseointegration, antimicrobial activities, and a reduced tendency to form cracks, see [0010].
It would have been obvious to one of ordinary skill in the art before the effective filing date of he claimed invention to have utilized a nanocrystalline coating comprising orthorhombic ZrO2, and KZr2(PO4)3 into the coatings of Zhongping et al. as modified by the teachings of Chevalier et al. and Trolliard et al. One of ordinary skill would have been motivated to do so because Anderson et al. teaches a method of applying crystalline nanoparticles onto the surface of an implant to produce an implant with a crystalline nanoparticle layer on the surface of implant comprising zirconium oxide and calcium phosphate wherein nanoparticle application is designed to control the thickness and uniformity of the nanoparticle layer, while simultaneously retaining the microroughness of the implant as discussed above and Malshe et al. teaches nanocrystalline coating on to an implant comprising hydroxy apatite and metal oxide in nanoparticle form wherein the micro-pattered or nanopores have a reduced tendency to form cracks. Thus, the references provide guidance as to the formation and application of nanocrystalline particles of coating comprising zirconium phosphate cand metal phosphate used for coating a substrate in an implant while having a benefit of controlling uniformity of nanoparticle layer along with reduced tendency of forming cracks as discussed above. Therefore, based on the guidance provided by Anderson et al. and Malshe et al. one of ordinary would have reasonable expectation of success in obtaining a nanocrystalline coating comprising the zirconium dioxide and multi-metal phosphate taught by Zhongping et al. as modified by Chevalier and Trolliard et al.
Regarding the CIELAB colour space, surface roughness and porosity falling in the claimed range, since the references discussed above make obvious the claimed metal body coated with the claimed zirconium oxide and group I-IV multi-metal phosphate, the above property would necessarily be present since property cannot be separated from the chemistry of the composition. "Products of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present, see MPEP 2112.01 (II).
(Note: The Examiner suggests writing “Groups” before I-IV multi-metal in claims).
Applicant’s arguments are moot in view of the new rejections made above addressing limitations of nanocrystalline coating.
Correspondence
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/SNIGDHA MAEWALL/Primary Examiner, Art Unit 1612