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 without traverse of Group I, claims 1-10, in the reply filed on 24 January 2026 is acknowledged. Accordingly, claims 11-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
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 9-10 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.
Claim 9 recites wherein the coating comprises about 35% at% titanium structural component. The claim is indefinite because the scope of the claim is unclear. It is not clear whether the titanium structural component recited in claim 9 refers to the titanium alloy structural component of claim 1, or the titanium coating component of claim 1.
Claim 10 recites the silver comprising coating. Claim 10 recites the limitation "the silver comprising coating" in line 2-3 of the claim. There is insufficient antecedent basis for this limitation in the claim. Claim 1, from which it depends, recites a coating comprising a silver coating component. To obviate this issue, it is suggested for claim 10 to recite either the coating or the silver coating component.
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.
Claims 1-9 are rejected under 35 U.S.C. 103 as being unpatentable over Link et al. (WO 2019/214992 A1, 11/14/2019) (hereinafter Link) in view of Pressacco (US 2021/0178015 A1, 06/17/2021).
Note: for the purposes of translation, the US equivalent of Link (US 2021/0128782 A1) will be cited.
Link discloses an implant component coated with a titanium nitride coating having 5-30 at% Ag (silver) in addition to an at% content Ti (titanium) and an at% content N (nitrogen) (abs). The at % content can be adjusted in its order of magnitude to the desired composition of the coating ([0030]). The silver is present in the form of silver agglomerates/islands, arranged next to the titanium nitride lattice ([0042]). The surface of the titanium nitride comprises deposits of silver or silver islands that is embedded to extend the antimicrobial range of protection ([0048]). The structure of the coating leads to at least part of the silver content being present on the coating surface ([0049]). The coating has a thickness of 2.5-6 µm ([0016]). The implant is suitable as bone implant ([0011]).
Link differs from the instant claims insofar as not explicitly disclosing a porous, titanium alloy structure.
However, Pressacco discloses protheses suitable as bone substitutes ([0001]) comprising titanium-based metal alloys, such as Ti6Al4V (abbreviated Ti64) ([0002]). The titanium-based metal alloys have high biocompatibility and high capacity to firmly attach to the bone (i.e. high osteointegration) and are therefore used to produce prostheses that are configured with a porous or trabecular shape ([0004]).
Accordingly, it would have been obvious for one of ordinary skill in the art to have included a titanium-based metal alloy, such as Ti6Al4V having a porous shape, as the implant of Link, since it is a known and effective substrate for bone implant offering high biocompatibility and high osteointegration as taught by Pressacco.
Regarding claim 9 reciting an at% of silver coating component, the claimed ranges (i.e. about 10 at%) would have been obvious to one of ordinary skill in the art since they overlap with the ranges of the prior art (i.e. 5-30 at% Ag). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP § 2144.05(I).
Regarding claim 9 reciting an at% of titanium and an at% of nitrogen, Link further discloses wherein the coating may comprise a content of at least 70 at% titanium nitride ([0047]).
Accordingly, it would have been obvious to one of ordinary skill in the art to have selected a content of Ti and a content of N, such that the total content is within the disclosed range of at least 70 at%. Such amounts selected would have equated to an at% that overlaps with the claimed ranges. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP § 2144.05(I). Moreover, in any case, the selection of appropriate atomic percentages would appear to require no more than routine testing on the part of the skilled artisan, and so alternatively it would have been obvious to determine workable ranges to arrive at the claimed amounts in at %. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." See MPEP § 2144.05(II)(A).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Link et al. (WO 2019/214992 A1, 11/14/2019) (hereinafter Link) in view of Pressacco (US 2021/0178015 A1, 06/17/2021), further in view of Anderson (US 2009/0054985 A1, 02/26/2009).
The disclosures of Link and Pressacco have been discussed in detail above, and differs from the instant claim insofar as not explicitly disclosing a Zr coating.
However, Anderson discloses a prosthetic device comprising an articulating titanium member, and a zirconium oxide layer formed by applying a coating of zirconium onto the titanium member (abs), thereby reducing wear of a prosthetic device ([0005]). The prosthetic device includes implantable devices such as artificial hips, knees, ankles, elbows, shoulders, as well as spinal cord implants ([0002]).
Accordingly, it would have been obvious to one of ordinary skill in the art to have included a zirconium layer adjacent to the titanium structure of Link, since it is a known and effective coating providing reduced wear of a titanium structure as taught by Anderson.
Citation of the State of the Art and Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Davidson (US 5,415,704 A, 05/16/1995), directed to biocompatible metallic medical implants.
Lee et al. (CN 105603375 A, 05/25/2016, IDS reference 03/08/2024), directed to a TiN/Ag film whose surface is rich in silver and doped with nitrogen.
Gan et al. (CN 105963781 A, 09/28/2016), directed to silver coated Ti6Al4V suitable as an implant.
Lee et al. (CN 105126167 A, 12/09/2015), directed to 3D printed porous Ti6Al4V alloy.
Moseke et al. (“Hard implant coatings with antimicrobial properties”, 10/16/2011, IDS reference 03/08/2024), directed to silver ion doped TiN coatings on Ti substrates, advantageously allowing for good mechanical properties of TiN and silver induced bactericidity.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LUCY TIEN whose telephone number is (571)272-8267. The examiner can normally be reached Monday - Thursday 8:30 AM - 6:30 PM EST.
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/LUCY M TIEN/ Examiner, Art Unit 1612
/SAHANA S KAUP/ Supervisory Primary Examiner, Art Unit 1612