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 .
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.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 0 has been entered. Claims 1-13 and 18-25 are pending in the
application. Claim 13 remains withdrawn from consideration and new claims 21-25 have been added. Claims 10 and 14-17 have been cancelled.
Response to Arguments
Applicant's arguments filed 05/16/2026 have been fully considered but they are not persuasive.
Applicant argues that Dehnad does not disclose a coating that forms a single TiNb layer with Ag, in which the Ag is dispersed within the TiNb matrix, and wherein the Ag is in the form of islets, since it is disclosed that the anodic metal (Ag) forms a continuous path through the coating and since the coating of the prior art requires galvanic action. The Examiner disagrees as it is explicitly disclosed in the specification of Dehnad that the Ag can be formed in clusters (e.g. islets, also shown by the “most all” in the recited quote from the reference in the arguments), that the coating can comprise of titanium and niobium (see paragraph [0069] denoting that the cathodic metal can be one or more of a list, said list including titanium and niobium), and as well as states that the Ag can be completely encapsulated by the TiNb coating meaning that they would in essence form a “single layer” (see paragraph [0052] denoting that the anodic metal can be in clusters, see also paragraphs [0058] and [0179] denoting that at least some of the anodic metal (Ag) is completely encapsulated by the cathodic metal (TiNb)). Furthermore, in response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., referring to the argument that the coating of the prior art relies on galvanic action and therefore does not read on the Instant Application) are not recited in the rejected claims. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Regarding the argument that Ziegler teaches away from the “PVD-applied, TiNb matrix with dispersed Ag islets,” one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Ziegler is not a primary reference nor is relied upon for PVD-application (which is a product by process limitation that is given limited patentable weight anyways as seen in the rejections below) or the TiNb matrix with Ag islets, and therefore it is not relevant that the specification of Ziegler teaches away from such limitations.
Regarding the argument that the applied prior art does not read on the new claims 23 and 24 because Gray is silent on “additive-method porosities,” the Examiner disagrees, as there is nothing in the new claims regarding “additive-method porosities,” and the rejections only rely on Gray for the porosity percentages and the size of the pores. Regarding Claims 22 and 25, new rejections have been applied. Regarding the argument that Dehnad would not read on claim 21, the Examiner disagrees as the reference explicitly discloses in the reference that the At% proportion of Ag can be lower than the At% proportion of Ti, thereby making the coating substoichiometric.
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.
Claims 1, 8, 9, 11, 18-19, 21, and 25 are rejected under 35 U.S.C. 103 as being unpatentable over US 20180093013 A1 (hereafter --Dehnad--).
Regarding Claim 1, Dehnad discloses an implant component which comprises: a solid material region; a surface structure connected to the solid material region (see annotated solid material region and surface structure in Figure 1 below); a coating which is provided on the surface structure (see Abstract) wherein the coating is a Physical Vapor Deposition (PVD)-applied (see paragraph [0181]), titanium niobium coating (TiNb-Ag) (see paragraph [0069] denoting that the cathodic metal can be one or more of a list, said list including titanium and niobium) that comprises an At% proportion of Ti as a main component, and Ag having an At% and an at% content of Nb (see Abstract, see also paragraph [0069]); wherein the surface structure comprises undercuts which are coated with the coating (see annotated undercuts in Figure 1 below, see also paragraph [0230] denoting the coating can be applied to the implant 1701), wherein Ti, Nb, and Ag are concurrently deposited as a single layer such that the Ag is present in the form of islets (see paragraph [0052] denoting that the anodic metal can be in clusters) dispersed within a TiNb matrix (see paragraphs [0058] and [0179] denoting that at least some of the anodic metal (Ag) is completely encapsulated by the cathodic metal (TiNb)).
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The limitation “simultaneously formed” is a is being treated as a product by process limitation; that is the coating is simultaneously formed. As set forth in MPEP 2113, product-by-process claims are NOT limited to the manipulations of the recited steps, only to the structure implied by the steps. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of 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). Thus, even though Dehnad as modified is silent as to the coating being “simultaneously formed”, it appears that the coating would be the same as that claimed.
Dehnad teaches the anodic metal (an option being silver) in the coating having an At% of at least 25 At% (see Abstract), in order to result in a network of anodic metal with less than 20% of the anodic metal in the coating fully encapsulated by cathodic metal (see Abstract). Dehnad fails to disclose the Ag having an exact At% proportion of 15-25 At%. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the coating of Dehnad from at least 25 At% to about 15-25 At% as claimed, since in the case where the claimed ranges "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).
Regarding Claim 8, Dehnad as modified discloses the implant component according to claim 1, wherein the silver proportion of the coating is at least 18 At%, 20 At% or 22 At% and at most 23 At%, 24 At% or 25 At% (see claim 1 rejection above).
Regarding Claim 9, Dehnad as modified discloses the implant component according to claim 1, wherein the coating is a PVD coating (see paragraph [0181]).
Regarding Claim 11, Dehnad as modified implant component according to claim 1, wherein the coating has a thickness of 1-6 um, 2.5-6 um or 3.5-5.5 um (see paragraph [0182]).
Dehnad as modified fails to disclose the Ag having an exact thickness of 1-6 um, 2.5-6 um or 3.5-5.5 um. Dehnad teaches the thickness of the anodic metal (an option being silver/Ag) to be between 10 microinches (0.254 um) to 500 microinches (12.7 um) (see paragraph [0182]), in order to be able to select the amount and duration (and/or timing) of the release of anodic metal (see paragraph [0182]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the thickness of the coating be from 10 microinches (0.254 um) to 500 microinches (12.7 um) to about -6 um, 2.5-6 um or 3.5-5.5 um as claimed, since in the case where the claimed ranges "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).
Regarding Claim 18, Dehnad as modified discloses the implant component according to claim 16.
Dehnad as modified fails to disclose wherein the silver islets are in a range of 1 pm to 50 pm. Dehnad teaches the thickness of the particles of anodic metal (an option being silver/Ag) to be under 0.01 mm, or under 10 um (see paragraph [0177]), as it is well known within the art to have the anodic metal in a coating form clusters of this size that are connected to an outer surface of the coating, so that they are exposed to the electrolytic bodily fluid (e.g., blood) (see paragraph [0177]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the size of the agglomerates be from under 10 um to about 1 um to 50 um as claimed, since in the case where the claimed ranges "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).
Regarding Claim 19, Dehnad as modified discloses the implant component according to claim 16.
Dehnad as modified fails to disclose wherein the silver islets are in a range of 5 pm to 30 pm. Dehnad teaches the thickness of the particles of anodic metal (an option being silver/Ag) to be under 0.01 mm, or under 10 um (see paragraph [0177]), as it is well known within the art to have the anodic metal in a coating form clusters of this size that are connected to an outer surface of the coating, so that they are exposed to the electrolytic bodily fluid (e.g., blood) (see paragraph [0177]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the size of the agglomerates be from under 10 um to about 5 um to 30 um as claimed, since in the case where the claimed ranges "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).
Regarding Claim 21, Dehnah as modified discloses the implant component according to claim 1, wherein the At% proportion of Ag is lower than the At% proportion of Ti, such that the distribution is substoichiometric (see paragraphs [0052] and [0081]).
Regarding Claim 25, Dehnah as modified discloses the implant component according to claim 1.
Dehnah fails to disclose wherein the coating is substantially stoichiometric.
The Instant Application does not disclose the coating being substantially stoichiometric solves any problem or is for any particular purpose, nor does it place criticality on the limitation (see paragraph [100791] denoting that it is not necessary for a stoichiometric distribution to be present, and that the distribution can be superstoichiometric or substoichiometric). It appears that Dehnah’s coating would perform equally and function as intended with the coating being substantially stoichiometric. Therefore, it would have been obvious to one having ordinary skill in the art to make the coating be substantially stoichiometric, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Claims 1 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over US 20130075267 A1 (hereafter --Shawcross--), in view of US 20180093013 A1 (hereafter --Dehnad--), and in further view of US 20200282108 A1 (hereafter --Wilson--).
Regarding Claim 1, Shawcross discloses an implant component which comprises: a solid material region; a surface structure connected to the solid material region (see annotated solid material region and polished regions in Figure 1 below, see paragraph [0041] denoting that the coating extends onto the polished portion for a distance of 0.5 mm, making that 0.5 mm portion of the implant that is polished with coating the “surface structure”); a coating which is provided on the surface structure (see paragraphs [0035] and [0041]) wherein the coating comprises an At% proportion of Ti as a main component (see paragraph [0035]).
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Shawcross fails to disclose wherein the coating is a Physical Vapor Deposition (PVD)-applied, simultaneously formed titanium niobium coating (TiNb-Ag), the coating having Ag as a further component having an At% proportion of 15-25 At%, and an at% content of Nb, and wherein the surface structure comprises undercuts which are coated with the coating, wherein Ti, Nb, and Ag are concurrently deposited as a single layer such that the Ag is present in the form of islets dispersed within a TiNb matrix.
Dehnad discloses an implant component which comprises: a solid material region; a surface structure connected to the solid material region (see annotated solid material region and surface structure in Figure 1 below); a coating which is provided on the surface structure (see Abstract) wherein the coating comprises an At% proportion of Ti as a main component, and Ag having an At% as a further component (see Abstract); wherein the surface structure comprises undercuts which are coated with the coating (see annotated undercuts in Figure 1 below, see also paragraph [0230] denoting the coating can be applied to the implant 1701). Dehnad teaches wherein the coating is a Physical Vapor Deposition (PVD)-applied (see paragraph [0181]), titanium niobium coating (TiNb-Ag) (see paragraph [0069] denoting that the cathodic metal can be one or more of a list, said list including titanium and niobium) that comprises an at% content of Nb (see Abstract, see also paragraph [0069]); the anodic metal (an option being silver) in the coating having an At% of at least 25 At% (see Abstract), in order to result in a network of anodic metal with less than 20% of the anodic metal in the coating fully encapsulated by cathodic metal (see Abstract), and wherein Ti, Nb, and Ag are concurrently deposited as a single layer such that the Ag is present in the form of islets (see paragraph [0052] denoting that the anodic metal can be in clusters) dispersed within a TiNb matrix (see paragraphs [0058] and [0179] denoting that at least some of the anodic metal (Ag) is completely encapsulated by the cathodic metal (TiNb)). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to provide Shawcross’s coating with Ag as a further component having an At% of Ag of at least 25 At%, wherein the coating is a Physical Vapor Deposition (PVD)-applied (see paragraph [0181]), titanium niobium coating (TiNb-Ag), and wherein Ti, Nb, and Ag are concurrently deposited as a single layer such that the Ag is present in the form of islets dispersed within a TiNb matrix, as taught by Dehnad as by doing so would enable the implant to have the antimicrobial ions (silver) be sustained on the implant over a predetermined time period of continuous or intermittent exposure to the bodily fluid (see paragraph [0049]), and would enable the implant to be used in delivering an antimicrobial ion (e.g., silver ions) to a bone repair site to prevent or treat infection (see paragraph [0230]). Further, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the coating of Dehnad to be from at least 25 At% to about 15-25 At% as claimed, since in the case where the claimed ranges "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). It additionally would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have the coating be a titanium niobium coating (TiNb-Ag) that comprises an at% content of Nb, as taught by Dehnad, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
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The limitation “Physical Vapor Deposition (PVD)-applied, simultaneously formed” is a is being treated as a product by process limitation; that is the coating is PVD-applied, simultaneously formed. As set forth in MPEP 2113, product-by-process claims are NOT limited to the manipulations of the recited steps, only to the structure implied by the steps. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of 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). Thus, even though Shawcross as modified is silent as to the coating being “PVD-applied, simultaneously formed”, it appears that the coating would be the same as that claimed.
Shawcross as modified further fails to disclose wherein the surface structure comprises undercuts which are coated with the coating.
Wilson discloses an orthopedic implant that has a surface structure that has a titanium substrate with silver deposited onto the implant, thereby having a polymeric coating on the implant (see paragraph [0058], see also implant in Figure 16A below). Wilson teaches wherein the surface structure comprises undercuts which are coated with the coating (see annotated undercuts in Figures 16A and 16B below, see also paragraph [0259]).
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Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the implant of Shawcross as modified to have the surface structure comprise of undercuts which are coated with the coating, as doing so would reduce the amount of contact points between the antimicrobial coating and the internal surfaces of the bone canal, thereby reducing the risk of abrasion of the antimicrobial coating (see paragraphs [0258] and [0259]).
Regarding Claim 6, Shawcross as modified by Dehnad and Wilson discloses the implant according to claim 1, wherein the surface structure is formed with a thickness of 0.5 mm (see annotated solid material region and polished regions in Figure 1 above, see paragraph [0041] denoting that the coating extends onto the polished portion for a distance of 0.5 mm, making that 0.5 mm portion of the implant that is polished with coating the “surface structure”).
Claims 1, 7-8, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over US 8834576 B1 (hereafter --Serafin--), in view of US 20180093013 A1 (hereafter --Dehnad--), in even further view of US 20060161256 A1 (hereafter --Ziegler--).
Regarding Claim 1, Serafin discloses an implant component which comprises: a solid material region; a surface structure connected to the solid material region (see annotated solid material region and surface structure in Figure 1 below); a coating which is provided on the surface structure (see column 5, lines 40-43); wherein the surface structure comprises undercuts which are coated with the coating (see annotated undercuts in Figure 1 below, see also column 5, lines 6-15).
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Serafin fails to disclose wherein the coating is a Physical Vapor Deposition (PVD)-applied, simultaneously formed titanium niobium coating (TiNb-Ag), the coating having Ag as a further component having an At% proportion of 15-25 At%, and an at% content of Nb, and wherein the surface structure comprises undercuts which are coated with the coating, wherein Ti, Nb, and Ag are concurrently deposited as a single layer such that the Ag is present in the form of islets dispersed within a TiNb matrix.
Ziegler discloses a coating to be put onto an implant (see Abstract). Ziegler teaches wherein the coating comprises an At% proportion of Ti as a main component, and Ag having an At% proportion of 1-20 At% as a further component (see paragraph [0035] the preferable percentage of the metal ions is 1-20%, see also paragraph [0036] that the metal ions could be silver salts or silver acetate). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to provide Serafin’s coating having an At% proportion of Ti as a main component, and Ag having an At% proportion of 1-20 At% as a further component as taught by Ziegler, as by doing so would enable the anti-microbial effect of the coating to be enhanced since in this case there would be an option to have a higher amount of metal ions having an anti-bacterial effect by ranging the At% according to specific needs (see paragraph [0042]). Further, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the coating of Ziegler to be from at least 1-20 At% to about 15-25 At% as claimed, since in the case where the claimed ranges "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).
Furthermore, Serafin as modified by Ziegler fails to disclose wherein the coating is a Physical Vapor Deposition (PVD)-applied, simultaneously formed titanium niobium coating (TiNb-Ag), wherein the coating comprises of an at% content of Nb, and wherein the surface structure comprises undercuts which are coated with the coating, wherein Ti, Nb, and Ag are concurrently deposited as a single layer such that the Ag is present in the form of islets dispersed within a TiNb matrix.
Dehnad discloses an implant component which comprises: a solid material region; a surface structure connected to the solid material region (see annotated solid material region and surface structure in Figure 1 below); a coating which is provided on the surface structure (see Abstract) wherein the coating comprises an At% proportion of Ti as a main component, and Ag having an At% as a further component (see Abstract); wherein the surface structure comprises undercuts which are coated with the coating (see annotated undercuts in Figure 1 below, see also paragraph [0230] denoting the coating can be applied to the implant 1701). Dehnad teaches wherein the coating is a Physical Vapor Deposition (PVD)-applied (see paragraph [0181]), titanium niobium coating (TiNb-Ag) (see paragraph [0069] denoting that the cathodic metal can be one or more of a list, said list including titanium and niobium) that comprises an at% content of Nb (see Abstract, see also paragraph [0069]), and wherein Ti, Nb, and Ag are concurrently deposited as a single layer such that the Ag is present in the form of islets (see paragraph [0052] denoting that the anodic metal can be in clusters) dispersed within a TiNb matrix (see paragraphs [0058] and [0179] denoting that at least some of the anodic metal (Ag) is completely encapsulated by the cathodic metal (TiNb)).
Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have the coating be a wherein the coating is a Physical Vapor Deposition (PVD)-applied, titanium niobium coating (TiNb-Ag), wherein the coating comprises of an at% content of Nb, wherein Ti, Nb, and Ag are concurrently deposited as a single layer such that the Ag is present in the form of islets dispersed within a TiNb matrix titanium niobium coating (TiNb-Ag) that comprises an at% content of Nb, as taught by Dehnad, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
The limitation “Physical Vapor Deposition (PVD)-applied, simultaneously formed” is a is being treated as a product by process limitation; that is the coating is PVD-applied, simultaneously formed. As set forth in MPEP 2113, product-by-process claims are NOT limited to the manipulations of the recited steps, only to the structure implied by the steps. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of 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). Thus, even though Serafin as modified is silent as to the coating being “PVD-applied, simultaneously formed”, it appears that the coating would be the same as that claimed.
Regarding Claim 7, Serafin as modified by Ziegler and Dehnad discloses the implant component according to claim 1, wherein the silver proportion of the coating is at least 18 At%, 20 At% or 22 At% and at most 23 At%, 24 At% or 25 At% (see paragraph [0035] the preferable percentage of the metal ions is 1-20%, see also paragraph [0036] that the metal ions could be silver salts or silver acetate).
Regarding Claim 8, Serafin as modified by Ziegler and Dehnad discloses the implant component according to claim 1.
Serafin fails to disclose wherein the coating comprises an At% proportion of N and/[or an At% proportion of Nb as a further coating component.
Zielger teaches wherein the coating comprises an At% proportion of N and/[or an At% proportion of Nb as a further coating component] (see paragraph [0026]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the coating of Serafin to include an At% proportion of N, as it is well known in the art to use nitrogen in multiple use cases for a coating, including in the form of nitrates as a counter ion (see paragraph [0036]), in the form of nitric acid as a mineral peptization acid (see paragraph [0032]), or in the form of nitrogen-containing alkyl or alkenyl radicals enabling coating formation and bonding (see paragraph [0026]).
Regarding Claim 12, Serafin as modified by Ziegler and Dehnad discloses the implant component according to claim 1.
Serafin as modified fails to disclose wherein the solid material region comprises an alloy or consists of said alloy and the alloy preferably comprises titanium as a main alloy component.
Ziegler teaches wherein the solid material region comprises an alloy or consists of said alloy and the alloy preferably comprises titanium as a main alloy component (see claims 5 and 6).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the solid material region of Serafin comprise an alloy or consists of said alloy and the alloy preferably comprises titanium as a main alloy component, as taught in Zielger, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Claims 2-5, 23, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over US 8834576 B1 (hereafter --Serafin--), in view of US 20180093013 A1 (hereafter --Dehnad--), in view of US 20060161256 A1 (hereafter --Ziegler--) as applied to claim 1 above, and further view of US 20190254840 A1 (hereafter --Gray--).
Regarding Claim 2, Serafin as modified by Ziegler and Dehnad discloses the implant component according to claim 1. Serafin as modified by Ziegler and Dehnad fails to disclose wherein the undercuts of the surface structure are at least partially formed by an open-pore structure.
Gray discloses a titanium implant (see paragraph [0033]) that has a surface structure with undercuts that has a porous or silver coating applied thereto (see paragraphs [0014] and [0036], see also implant 100 and annotated undercuts 112A/112B in Figures 4 and 5 below). Gray teaches wherein the undercuts of the surface structure are at least partially formed by an open-pore structure (see paragraph [0037]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the undercuts of the surface structure of Serafin to be at least partially formed by an open-pore structure, as by doing so would facilitate bone fusion with the implant as taught by Gray (see paragraph [0038]).
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Regarding Claim 3, Serafin as modified by Ziegler, Dehnad, and Gray discloses the implant component according to claim 2, wherein the open-pore structure was generated by means of a plasma spray coating (see column 5, lines 34-39 denoting that there could be a plasma spray coating). The claimed phrase “wherein the open-pore structure was generated by means of a plasma spray coating” is being treated as a product by process limitation; that is the open-pore structure were generated by means of a plasma spray coating. As set forth in MPEP 2113, product-by-process claims are NOT limited to the manipulations of the recited steps, only to the structure implied by the steps. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of 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). Thus, even though Serafin as modified is silent as to the process used to make the open-pore structure of the implant article, it appears that the open-pore structure would be the same as that claimed.
Regarding Claim 4, Serafin as modified by Ziegler, Dehnad, and Gray discloses the implant component according to claim 2, wherein the open-pore structure (as modified by Gray) comprises substantially regularly arranged unit cells and the unit cells are preferably designed as tetrapod-like basic elements (see annotated unit cells in Figure 1 above being square shaped with four sides).
Regarding Claim 5, Serafin as modified by Ziegler, Dehnad, and Gray discloses the implant component according to claim 2.
Serafin as modified fails to disclose wherein the open-pore structure has a porosity of 10% to 80% and/or a pore width of 45 to 1000 um.
Gray further teaches wherein the open-pore structure has a porosity of 75% to 85% with 300-800 um pores (see paragraph [0037]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have Serafin’s modified surface structure undercuts be partially formed of an open-pore structure that has a porosity of 75% to 85% with 300-800 um pores as taught by Gray, as by doing so would make the surface of the implant undercuts have a stiffness equal to or greater than cancellous bone (see paragraph [0037]), to facilitate bone fusion with the implant (see paragraph [0038]). Further, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the open-pore structure of Gray have a porosity of 75% to 85% with 300-800 um pores to about 10% to 80% with 45-1000 um pores as claimed, since in the case where the claimed ranges "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).
Regarding Claim 23, Serafin as modified discloses the implant component according to claim 2.
Serafin fails to disclose wherein the open-pore structure has a porosity of 50% to 80%.
Gray further teaches wherein the open-pore structure has a porosity of 75% to 85% (see paragraph [0037]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have Serafin’s modified surface structure undercuts be partially formed of an open-pore structure that has a porosity of 75% to 85% as taught by Gray, as by doing so would make the surface of the implant undercuts have a stiffness equal to or greater than cancellous bone (see paragraph [0037]), to facilitate bone fusion with the implant (see paragraph [0038]). Further, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the open-pore structure of Gray have a porosity of 75% to 85% to about 50% to 80% as claimed, since in the case where the claimed ranges "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).
Regarding Claim 24, Serafin as modified discloses the implant component according to claim 2, wherein the open-pore structure has a pore width in a range of 100 pm to 300 pm. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the modified region of Serafin as modified to extend from between 100 pm to 300 pm to 300 pm to 900 pm as claimed, since in the case where the claimed ranges "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). Further, applicant appears to have placed no criticality on the claimed range (see [100711] indicating the range can be within 100 to 1000 pm).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over US 8834576 B1 (hereafter --Serafin--), in view of US 20180093013 A1 (hereafter --Dehnad--), in view of US 20060161256 A1 (hereafter --Ziegler--) in further view of US 20190254840 A1 (hereafter --Gray--), as applied to claim 2 above, in even further view of US 20130204078 A1 (hereafter --Li--).
Regarding Claim 20, Serafin as modified by Ziegler, Dehnad, and Gray discloses the implant component according to claim 2.
Serafin as modified by Ziegler, Dehnad, and Gray fails to disclose wherein a ratio between a widest cross section and a narrowest cross section of a pore of the open-pore structure is 4:1 or less.
Li discloses surgical films for soft tissue repair for implantation into a patient (see Abstract), in which the films comprise of an open porous structure (see paragraphs [0020] and [0040]). Li teaches wherein a ratio between a widest cross section and a narrowest cross section of a pore of the open-pore structure is 4:1 or less (see paragraph [0041] denoting that the shape of a pore can be oval with one plane of symmetry, the ratio between length and width being within a range of 2:1-5:1, which overlaps with 4:1 or less as claimed), as it is well known within the art to alter the size and shape of pores of an implant to prevent or promote tissue in-growth based on the use case (see paragraphs [0040] and [0041]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the size of the agglomerates be from within the range of range of 2:1-5:1 about 4:1 or less as claimed, since in the case where the claimed ranges "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 22 is rejected under 35 U.S.C. 103 as being unpatentable over US 20180093013 A1 (hereafter --Dehnad--), in view of US 20050171615 A1 (hereafter –Georgette--).
Regarding Claim 22, Dehnad discloses the implant component according to claim 1.
Dehnad fails to disclose wherein the surface structure has a roughness Ra in the range of 20 pm to 80 pm.
Georgette discloses an implant with a surface structure and a coating applied to said surface (see Abstract, see also paragraph [0190]). Georgette teaches wherein the surface structure has a roughness Ra in the range of 0.02 pm to 75 pm (see paragraph [0038]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the surface structure of Dehnah as modified be in the range of 0.02 pm to 75 pm. Doing so would promotes attachment of the implant to neighboring tissues, encourages tissue in-growth, and helps to prevent movement of the device after implantation (see paragraph [0038]). Further, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the roughness of the surface structure of Dehnad be in the range of 0.02 pm to 75 pm to in the range of 20 pm to 80 pm as claimed, since in the case where the claimed ranges "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). Further, applicant appears to have placed no criticality on the claimed range (see [100631] indicating the roughness “can” be within the claimed range).
Conclusion
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/PARIS MARIE BLASS/Examiner, Art Unit 3774
/MELANIE R TYSON/Supervisory Patent Examiner, Art Unit 3774
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