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 .
Claims 1-13, 16-18, and 21-24 are pending; claims 1-10 and 21-24 are examined; claims 11-13, and 16-18 are withdrawn.
Applicant’s arguments, filed 01 June 2026, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 2-5 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 1 has been amended and appears to recite all the limitations of claims 2-5. Accordingly, claims 2-5 fail to further limit the subject matter of claim 1.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claims 1-9 and 24 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 at%’s that appear to overlap 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).
Regarding claim 24 reciting an at% of nitrogen, 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% of N that appears to overlap 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).
Response to Arguments
Applicant mainly asserts that Link does not disclose or suggest the specific structural arrangement recited in claim 1, wherein “a first portion of the silver agglomerates are partially within, and partially exposed from, the titanium nitride” and “a second portion of the silver agglomerates are within the titanium nitride.” Link’s teaching of silver islands on the surface of the coating does not describe this dual-portion configuration where some silver agglomerates are partially exposed while others are entirely within the titanium nitride matrix.
The Examiner appreciates Applicant’s clarification but does not find Applicant’s assertion to be persuasive. As discussed above in the rejection, Link discloses wherein the silver is present in the form of silver agglomerates/islands. The surface of the titanium nitride comprises deposits of silver/silver islands that are embedded to extend the antimicrobial range of protection. The structure of the coating leads to at least part of the silver content being present on the coating surface. Accordingly, it reasonably appears that a portion of the silver, in the form of agglomerates, is on the coating surface, i.e., partially within and partially exposed from titanium nitride; thus, a second portion of the silver would be not on the coating surface, i.e., within the titanium nitride.
Moreover, in any case, purely arguendo, even if the aforementioned arrangement isn’t immediately obvious, Link further explains at para. [0017] that no continuous sections of silver are formed in the thickness direction in the structure of the coating. In other words, owing to the three-dimensional heterogeneous structure of the titanium nitride/silver coating, there is an in principle continuous titanium nitride coating. Link also discloses in para. [0042] that the coating comprises at least one layer of the titanium nitride coating, in which silver is embedded.
Accordingly, it would reasonably appear to one of ordinary skill in the art that Link teaches or at least suggests wherein the structure of the coating layer comprises a portion of the silver agglomerates are partially within and partially exposed from the titanium nitride (i.e. from the outermost layer), and a second portion are within the titanium nitride (i.e. any layers aside from the outermost layer of the coating). As such, Applicant’s assertions are unpersuasive.
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.
Response to Arguments
Applicant does not present specific arguments with regard to Link and Anderson.
Since the Examiner has discussed Link above, this rejection is maintained.
Claims 1-4, 6-10, and 21-24 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 Bauer (US 2018/0193152 A1, 07/12/2018).
Note: for the purposes of translation, the US equivalent of Link (US 2021/0128782 A1) will be cited.
The disclosure of Link has been discussed in detail above. While Link is believed to support a finding of obviousness, purely arguendo, for the purposes of complete prosecution, and for the purposes of this ground of rejection only, Link will be interpreted as though it does not explicitly disclose a porous, titanium alloy as instantly claimed.
Link further discloses wherein the implant component comprises a titanium alloy implant ([0027]).
Link differs from the instant claim insofar as not explicitly disclosing wherein the titanium alloy is a porous structure.
However, Bauer discloses a bone implant having a porous structure and having a size and shape configured for fitment to a bone, wherein the porous structure is comprised of regularly arranged elementary cells whose interior spaces form interconnected pores, wherein the elementary cells are formed by basic elements arranged in layers, wherein the basic elements are shaped like tetrapods, the tetrapods in each layer being arranged in parallel orientation and being positioned in their layer rotated with respect to the tetrapods of an adjacent layer ([0007]). The “tetrapod” is known to the person skilled in the art as being an element having four legs emanating from a common center ([0009]). Such a structure has the advantage that stiffness is not uniform in all three directions of space, demonstrating a higher degree of biocompatibility and avoiding unwanted bone degradation ([0021]). The porous structure may be a biocompatible material including titanium alloys such as Ti6Al4V, which is regularly available and offers higher stiffness, optionally with a coating comprising zirconium ([0028]).
Accordingly, it would have been obvious to one of ordinary skill in the art to have included a bone implant having a porous structure as the implant of Link, since it is a known and effective titanium alloy structure providing improved biocompatibility as taught by Bauer.
Regarding claim 21, Bauer further discloses wherein the average pore width ranges between 0.1 and 1.5 mm (i.e. 100 to 1500 µm) ([0034]). Accordingly, it would have been obvious to one of ordinary skill in the art to have included pores ranging between 0.1-1.5 mm since it is a known and effective range suitable for bone implant structure as taught by Bauer.
Regarding claim 22, Bauer does not explicitly disclose an overall porosity. However, it would have taken no more than the relative skill of one of ordinary skill in the art to have arrived at the claimed ranges (i.e. about 30% to about 90%) through routine experimentation based on the level of porosity desired. "[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).
Regarding claim 23, as discussed above, Bauer discloses wherein the tetrapod structure has four legs emanating from a common center.
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
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, SAHANA KAUP can be reached at (571) 272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LUCY M TIEN/ Examiner, Art Unit 1612
/SAHANA S KAUP/ Supervisory Primary Examiner, Art Unit 1612
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