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.
Response to Amendment
The amendment filed 08/10/2026 has been entered. Claims 1-9, 11-12, 19-23, and 25 remain pending in the application. Claims 18 and 24 have been cancelled. New claims 26-27 have been added.
Response to Arguments
Applicant's arguments filed 08/10/2026 have been fully considered but they are not persuasive.
Applicant’s argument that Dehnad discloses the structurally opposite structure than the structure that is in the claims, and therefore does not read on the claims, the Examiner respectfully disagrees. Dehnad disclosing that the 80% of the silver can be interconnected, and therefore cannot be considered as islets, is disagreed upon. Islets, or otherwise defined as agglomerates in the Instant Application, (see paragraph [100721]), is defined as “a jumbled mass or collection” (see Merriam Webster Online), and islet is defined as “a small island” (see Merriam Webster online). The around 80% of connected silver can be considered an islet, and the other 20% can be considered islets as well, since they are jumbled masses and collections of silver. The continuous clumps of silver is exactly that, with only 80% of the silver being connected (see paragraph [0053]), meaning there are other clumps of silver surrounded by the matrix of the continuous coating (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)).
Applicant’s argument that Dehnad wants to “prevent entrapment,” being for a different purpose, and therefore the clusters do not read on the claim, the Examiner disagrees. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Furthermore, Applicant’s argument that the prior art is not structured as claimed, and therefore the product by process rationale should support patentability, the Examiner disagrees. The Examiner asserts that the prior art is structured as claimed as argued above. Applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references.
Applicant’s argument that the prior art does not disclose the “TiNb matrix,” the Examiner respectfully disagrees. The prior art gives options to what the cathodic metal could be, not “alternative cathodic metals,” and the reference explicitly says that the cathodic metals can be one or more of the listed metals (see paragraph [0069] denoting that the cathodic metal can be one or more of a list, said list including titanium and niobium). This in itself is enough disclosure to cover the claimed language.
Regarding Applicants criticism of Ziegler (page 10), mentioning that it teaches away from PVD, the Examiner disagrees that this is relevant to the rejections. For clarification, Ziegler is not relied upon for teaching PVD. Dehnad is relied upon for teaching PVD [0181] in combination with the coating having an at% content of Nb, Ti, Nb, and Ag are as a single layer such that the Ag is present in the form of islets surrounded by and dispersed within a continuous TiNb matrix, wherein no section of the coating that is continuous in a thickness direction of the coating is formed from silver. Zeigler is merely relied upon for teaching the particular makeup of a titanium niobium coating, specifically for having an At% proportion of Ti as a main component, and Ag having an At% proportion of 1-20 At% as a further component. 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). Additionally, a reference does not teach away if it merely expresses a general preference for an alternative invention but does not 'criticize, discredit, or otherwise discourage' investigation into the invention claimed." (quoting In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004)).
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.
Claim 1rejected 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.
Regarding Claim 1, the limitation “wherein no section of the coating that is continuous in a thickness direction of the coating is formed from sliver” is unclear, as it is not clear how the coating can have “Ti, Nb, and Ag are concurrently deposited as a single layer such that the Ag is present in the form of islets surrounded by and dispersed within a continuous TiNb matrix,” while also having no section of the coating in a thickness direction made of silver. The word “sliver” is noted as a misspelling of silver. For purposes of expedited prosecution the Examiner is interpreting this to mean that “wherein no section of the coating that is continuous in a thickness direction of the coating is formed only of silver”. Even if the limitation did mean that there should be no section made of silver, this does not make sense, as the claimed language discloses that all of the elements are within one layer, and there are silver islets throughout the coating meaning there would inevitably be silver in at least a few “sections” of the coating in the “thickness” direction. Clarification is required. Claims 2-9, 11, 12, 19-23, and 25-27 are rejected for being dependent on claim 1.
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, 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 surrounded by and (see paragraph [0052] denoting that the anodic metal can be in clusters) dispersed within a continuous TiNb matrix (see paragraphs [0058] and [0179] denoting that at least some of the anodic metal (Ag) is completely encapsulated (surrounded) by the cathodic metal (TiNb)), wherein no section of the coating that is continuous in a thickness direction of the coating is formed only of sliver (see again paragraphs [0058] and [0179] denoting that at least some of the anodic metal (Ag) is completely encapsulated (surrounded) by the cathodic metal (TiNb)).
PNG
media_image1.png
227
563
media_image1.png
Greyscale
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 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 Dehnad’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]).
PNG
media_image2.png
248
435
media_image2.png
Greyscale
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 surrounded by and dispersed within a continuous TiNb matrix, wherein no section of the coating that is continuous in a thickness direction of the coating is formed from sliver.
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 surrounded by and (see paragraph [0052] denoting that the anodic metal can be in clusters) dispersed within a continuous TiNb matrix (see paragraphs [0058] and [0179] denoting that at least some of the anodic metal (Ag) is completely encapsulated (surrounded) by the cathodic metal (TiNb)), wherein no section of the coating that is continuous in a thickness direction of the coating is formed only of sliver (see again paragraphs [0058] and [0179] denoting that at least some of the anodic metal (Ag) is completely encapsulated (surrounded) 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 surrounded by and dispersed within a continuous TiNb matrix, wherein no section of the coating that is continuous in a thickness direction of the coating is formed from sliver, 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 taught by 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.
PNG
media_image1.png
227
563
media_image1.png
Greyscale
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]).
PNG
media_image3.png
435
680
media_image3.png
Greyscale
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).
Furthermore, Serafin as modified 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 Nbwherein Ti, Nb, and Ag are as a single layer such that the Ag is present in the form of islets surrounded by and dispersed within a continuous TiNb matrix, wherein no section of the coating that is continuous in a thickness direction of the coating is formed from sliver.
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 surrounded by and (see paragraph [0052] denoting that the anodic metal can be in clusters) dispersed within a continuous TiNb matrix (see paragraphs [0058] and [0179] denoting that at least some of the anodic metal (Ag) is completely encapsulated (surrounded) by the cathodic metal (TiNb)), wherein no section of the coating that is continuous in a thickness direction of the coating is formed only of sliver (see again paragraphs [0058] and [0179] denoting that at least some of the anodic metal (Ag) is completely encapsulated (surrounded) by the cathodic metal (TiNb)).
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 of Serafin be a 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 surrounded by and dispersed within a continuous TiNb matrix, wherein no section of the coating that is continuous in a thickness direction of the coating is formed from sliver, 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.
PNG
media_image4.png
360
386
media_image4.png
Greyscale
Serafin as modified further fails to disclose wherein the coating has Ag as a further component having an At% proportion of 15-25 At%, and an at% content of Nb.
Ziegler discloses another implant with a coating (see Abstract) and teaches a particular composition suitable for coating an implant. 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). This composition has the benefit of enhancing the antimicrobial effect of the coating, 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]). In light of Ziegler’s teaching, one of ordinary skill in the art would have found it obvious to use the composition taught by Ziegler for the coating of Serafin, being an At% proportion of Ti as a main component, and Ag having an At% proportion of 1-20 At% as a further component, in order to 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).
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 27 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]).
PNG
media_image5.png
637
655
media_image5.png
Greyscale
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 27, Serafin as modified discloses the implant according to claim 2, wherein the open-pore structure comprises substantially regularly arranged unit cells (see annotated unit cells in Figure 1 above being square shaped with four sides).
The limitation “wherein the open-pore structure comprises substantially regularly arranged unit cells produced by an electron beam layer-melting method” is a is being treated as a product by process limitation; that is the regularly arranged unit cells are produced by an electron beam layer-melting method. 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 unit cells being “produced by an electron beam layer-melting method”, it appears that the open-pore structure would be the same as that claimed.
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).
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over US 20180093013 A1 (hereafter --Dehnad--), in view of US 20250195888 A1 (hereafter –Chiapetta--).
Rgearding Claim 26, Dehnad discloses the implant component according to claim 1.
Dehnah fails to disclose wherein the coating comprises an At% proportion of N and an At% proportion of Nb such that the coating is a titanium nitride-niobium coating with a silver proportion (TiNbN-Ag).
Chiapetta discloses an implant that goes into the body, that has a coating on said implant (see Abstract, see paragraph [0079]). Chiapetta teaches wherein the coating could be comprised of silver, niobium, and titanium nitride (see paragraph [0079]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention for the coating to comprise of an At% proportion of N and an At% proportion of Nb such that the coating is a titanium nitride-niobium coating with a silver proportion (TiNbN-Ag), 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.
Conclusion
THIS ACTION IS MADE FINAL. 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 PARIS MARIE BLASS whose telephone number is (703)756-5375. The examiner can normally be reached Monday - Thursday 9 a.m. - 7 p.m. ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached at 571-272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/PARIS MARIE BLASS/Examiner, Art Unit 3774
/SARAH W ALEMAN/Primary Examiner, Art Unit 3774
Prosecution Insights