DETAILED ACTION
Status of the Claims
Claims 9, 13-15, 17, 19-29 are pending in the instant application and are being examined on the merits in the instant application. Claims 21-29 are newly presented.
Request for Continued Examination
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 11/21/2025 has been entered.
Advisory Notice
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
All rejections and/or objections not explicitly maintained in the instant office action have been withdrawn per Applicants’ claim amendments and/or persuasive arguments.
Priority
The U.S. effective filing date has been determined to be 10/22/2020, the filing date of the U.S. Provisional Application No. 63/104,241.
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 9, 14-15, 19-22, 24-25 and 27-29 are rejected under 35 U.S.C. 103 as being unpatentable over OSTRUM (US 2013/0344123; published December, 2013) in view of Outten et al. (“Development of Titanium Nitride Fractal Coatings for Cardiac and Neural Electrostimulation Electrodes,” 2014; 57th Annual Technical Conference Proceedings, pp. 33-37); Samberg et al. (“Biocompatibility analysis of an electrically-activated silver-based antibacterial surface system for medical device applications,” 2013; Journal of Materials Science: Materials in Medicine, Vol. 24, No. 3, pp. 755-760) and FIELDS (US 6,539,252; published March, 2003).
Applicants Claims
Applicant claims an electrode article that is implantable in a subject, the article comprising: an electrode substrate having a surface; a bacterial layer comprising a bactericidal metal element and a titanium nitride (TiN) or zirconium nitride (ZrN) columnar microstructure; wherein the bactericidal metal element comprises copper or silver, wherein the TiN or ZrN columnar microtructure comprises pilliars having pores therebetween, and wherein the bactericidal layer is stably adhered to at least on portion of the surface of the electrode substrate; and a power source configured to apply an electrical potential to the bactericidal layer, wherein the bactericidal layer, wherein ions of the bictericidal metal element are released from the compositeinto the pores of the bactericidal layer in response to the application of electrical potential to the bactericidal layer, and wherein the pores of the bactericidal layer allow for released ions of the bactericidal metal element to diffuse into a bodily fluid which is in contact with the electrode article. (instant claim 9).
Applicant claims an electrode article that is implantable in a subject, the article comprising: an electrode substrate having a surface; a bactericidal layer comprising a multilayer structure comprising: a composite layer comprising a bactericidal metal element and a first portion of a TiN or ZrN columnar microstructure, a TiN or ZrN layer comprising a second portion of the TiN or ZrN columnar microstructure, but without the bactericidal metal element, wherein the bactericidal metal element comprises copper or silver, wherein the TiN or ZrN columnar microstructure formed by the composite layer and the TiN or ZrN layer comprises pillars having pores therebetween, wherein the bactericidal layer is stably adhered to at least one portion of the surface of the electrode substrate; and a power source configured to apply an electrical potential to the bactericidal layer; wherein ions of the bactericidal metal element are released from the composite layer into the pores of the bactericidal layer in response to the application of electrical potential to the bactericidal layer, and wherein the pores of the bactericidal layer allow for released ions of the bactericidal metal to diffuse into a bodily fluid which is in contact with the electrode (new claim 22).
Determination of the scope
and content of the prior art (MPEP 2141.01)
OSTRUM teaches use of silver-containing layers at implant surfaces, “The silver is present in a microparticulate or nanoparticulate form, which exerts antimicrobial activity when bacteria (e.g., in a body fluid) contact the coated surface.” (see whole document, particularly the title & abstract).
Regarding claims 9 and 22 OSTRUM teaches "coatings that contain silver," wherein the silver "exerts antimicrobial activity when bacteria… contact the coated surface" (Abstract), and that articles comprising the coating are implantable in an animal (Claim 1). OSTRUM further teaches that "the surface can also be coated with other substances, such as diamond-like carbon or alumina, either as a discrete layer or intermixed with the silver-containing particles" [emphasis added](Abstract). And further that: “The antimicrobial layer can include or be coated with other materials, such as alumina or diamond-like carbon (DLC). By way of example, these materials can be uniformly mixed, laminated as separate layers (e.g., a porous layer enclosing the antimicrobial layer), or mixed such that the composition varies in different portions of the layer.” [emphasis added]([0013]).
Specifically regarding the multilayer structure including a bactericidal metal element composite layer below a layer without the bactericidal metal element (instant claim 22, lines 4-8), OSTRUM teaches that: “The antimicrobial layer can include or be coated with other materials, such as alumina or diamond-like carbon
(DLC). By way of example, these materials can be uniformly mixed, laminated as separate layers (e.g., a porous layer enclosing the antimicrobial layer), or mixed such that the composition varies in different portions of the layer.” ([0013]). And that: “For instance, use of multiple sources facilitates deposition of discrete layers of different materials, mixing of sputtered materials at the atomic level, or a combination of these.” ([0029]). OSTRUM teaches the embodiment wherein: “The implants described have a coating which includes Ag. In one embodiment, Ag is intermixed with a DLC material, and the mixed material is laid down ( e.g., via simultaneous sputtering from discrete Ag and DLC sputtering cathodes) as a substantially homogenous DLC-Ag matrix. HA [(hydroxyapatite)] can also be co-sputtered with Ag, or with both Ag and DLC to form similarly substantially homogenous matrices. Alternatively, or in addition, discrete layers of one or more of these materials can be laid down in a coating by operating the corresponding sputtering cathode(s) selectively. Thus, for example, a titanium implant having a coating can be made by sputtering substantially only HA onto a titanium surface of
the implant, then sputtering a mixture of Ag and HA to form a mixed Ag-HA layer, then sputtering a mixture of Ag, HA, and DLC to form a mixedAg-HA-DLC layer, then sputtering a mixture of Ag and DLC to form a mixedAg-DLC layer, and finally sputtering substantially only DLC to form an outer DLC layer. In such an example, HA (or borosilicate glass used in its place) can serve to anchor the coating to the titanium surface, Ag mixed with the HA and DLC materials can release Ag ions and exert an antimicrobial effect, and DLC can inhibit adhesion of bacteria and other biomaterials to the coated implant.” [emphaisis added]([0034]).
OSTRUM further teaches that: “
Thin-films, on the orderofl 0 nm to 10 micrometers thick, can be readily synthesized using sputtering techniques. Sputtered films have several major advantages when compared to films grown using other technologies. Those advantages include excellent adhesion to many substrate materials, outstanding compositional control when deposited from mutiple sources, ability to form discrete layers or allow atomic mixing, and the technique is applicable as a deposition method for most materials.” ([0037]).
The example substrates include titanium and stainless steel (Example 1, page 6)(instant claim 14 & 24). OSTRUM teaches coated implants including pacemaker components (e.g., the outer case), nerve-interface electrodes ([0026], [0027])(instant claims 9 & 21, a power source configured to apply an electrical potential to the bactericidal layer).
OSTRUM teaches that: “Ag exhibits bactericidal properties both upon bacterial cells that are in direct contact with an Ag-containing surface and upon bacterial cells that do not directly contact the Ag-containing surface. Without being bound by any particular theory of operation, it is believed that the non-contact bactericidal effect of Ag is mediated by Ag ions.” [emphasis added]([0051]).
Ascertainment of the difference between
the prior art and the claims (MPEP 2141.02)
The difference between the rejected claims and the teachings of OSTRUM is that OSTRUM does not expressly teach a columnar microstructure.
Outten et al. teaches that: "Development of Titanium Nitride Fractal Coatings for Cardiac and Neural Electrostimulation Electrodes," (title, see whole document), and particularly, “This work deals with the development of reactively sputtered fractal titanium nitride coatings for use in electrostimulation and recording electrodes. Electrical stimulation of cardiac and nerve tissues is an active area of research. This presentation will focus on the process development and characterization of porous, columnar titanium nitride coatings that exhibit high electrochemically active surface areas. Depositions were conducted in an industrial-scale sputtering system with substrate temperature varying between 25 – 130°C. Low-temperature deposition of high surface area coatings is presented. These coatings are of particular interest for stimulation electrodes where dimensional stability is a concern, for example implantable neural prostheses leads. The coating microstructure was investigated with Focused Ion Beam Microscopy. These results were used to assess the impact of substrate temperature on film porosity and grain size.” [emphasis added](Abstract, page 33). Outten further teaches that these coatings “are used to improve the performance of electrostimulation and recording electrodes for cardiac and neural prostheses and treatments” [emphasis added](Introduction, page 33)(instant claim 1, An electrode article that is implantable in a subject, the article comprising: an electrode substrate having a surface […] wherein the columnar microstructure comprises pillars having pores therebetween”; instant claims 11-12 - metal nitride, titanium nitride).
Outten et al. teaches that: “This work has shown that fractal TiN coatings can be deposited by DC magnetron sputtering […].” (p. 36, col. 2, lines 1-2), which is consistent with the disclosure of OSTRUM teaching the advantages of sputtering techniques – “Sputtered films have several major advantages when compared to films grown using other technologies.” ([0037]).
OSTRUM teaches that the silver coating may comprise additional layers (Abstract), and that the coating may be applied to pacemakers (Paragraph [0018]), and while Outten et al. teaches that the titanium nitride coating may be applied to devices for cardiac electrostimulation, and that titanium nitride “is an ideal material for [electrostimulation] applications due to its electrical conductivity, chemical stability, and biocompatibility” (Introduction, page 33), one of ordinary skill in the art at the time of instant filing would be motivated to combine the teachings of OSTRUM and Outten et al. because OSTRUM teaches a coating that may be applied to a pacemaker, and Outten et al. teaches a coating that is beneficial for electrostimulation. Such a combination would result in a composite coating that is antibacterial, with high conductivity, chemical stability, and biocompatibility with the silver composite layer adhering over the surface and the columnar layer adhering to the silver composite layer. The adhering would take place due to the coating procedures including sputtering.
Furthermore, the silver coating of OSTRUM and the titanium nitride coating of Outten et al. are construed to be equivalents known in the art to be beneficial for coating implants. "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (MPEP § 2144.06). Thus, it is obvious to combine them to form a coating suitable for an implant.
OSTRUM teaches that the silver is deposited via a sputter deposition technique (Example 1, page 6) and that “[s]puttering of Ag is simple with a direct current (DC) power supply connected to a DC magnetron cathode” (Paragraph [0038]). OSTRUM further teaches that “[b]y mixing reactive gases (e.g., oxygen containing gases such as O2 and nitrogen containing gases such as N2) during deposition, the dissolution rate can be… modified” (Paragraph [0055]) and that “[t]his understanding provides a technique for selecting the dissolution rate and the rate of bactericidal action of the coatings” (Paragraph [0056]). Outten et al. teaches that “[f]ractal TiN films were deposited using DC reactive magnetron” (Experimental Procedures, page 33) and that “depositions were carried out in an Ar and N2 gas mixture” (Surface Morphology, page 34). It is obvious to use the method disclosed by OSTRUM and Outten et al. to deposit the coating layers disclosed therein. Thus, an electrode article produced via known methods resulting in a product of claims 9 and 22 are obvious.
Outten et al. teaches "titanium nitride coatings for use in electrostimulation and recording electrodes," wherein the coatings are "porous, columnar titanium nitride coatings that exhibit high electrochemically active surface areas" (Abstract, page 33). Outten et al. further teaches that these coatings “are used to improve the performance of electrostimulation and recording electrodes for cardiac and neural prostheses and treatments” (Introduction, page 33).
OSTRUM teaches that the silver coating may comprise additional layers (Abstract), and that the coating may be applied to pacemakers (Paragraph [0018]), while Outten et al. teaches that the titanium nitride coating may be applied to devices for cardiac electrostimulation, and that titanium nitride “is an ideal material for [electrostimulation] applications due to its electrical conductivity, chemical stability, and biocompatibility” (Introduction, page 33). One of ordinary skill in the art before the time of instant filing would be motivated to combine the teachings of OSTRUM and Outten et al. because OSTRUM teaches a coating that may be applied to a pacemaker, and Outten et al. teaches a coating that is beneficial for electrostimulation. Such a combination would result in multi-layered coating that is antibacterial, with high conductivity, chemical stability, and biocompatibility.
The silver coating of OSTRUM and the titanium nitride coating of Outten et al. are construed to be equivalents known in the art to be beneficial for coating implants. "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (MPEP § 2144.06). Thus, it is obvious to combine them to form a coating suitable for an implant.
Furthermore, because OSTRUM and Outten et al. both disclose that the coatings may be applied to pacemakers (OSTRUM: [0018]) and “electrodes for cardiac and neural prostheses treatments” (Outten et al., Introduction, page 33), it is obvious that the combination of these coatings could be applied to components of a pacemaker, which would inherently include an electrode.
Regarding claims 19 and 27, as discussed above for claims 9 and 22, it is obvious that the coatings could be applied to a pacemaker, which would inherently comprise a power source. Outten et al. teaches the electrochemical properties of the TiN-coated substrate at voltages ranging from -0.8 to +0.8 V (Fig. 3, page 35). A person of ordinary skill in the art would have a reasonable expectation of success that the optimal electrical potential for a coating that comprises TiN would fall somewhere in that range, and a person of ordinary skill in the art, through routine optimization, could determine the optimal electrical potential to maximize the efficiency of the electrostimulation device. Additionally, FIELDS teaches “A method and apparatus for destroying blood borne pathogens is disclosed which utilizes a low intensity direct current to generate positive particles from various metals which destroy viral pathogens.” (Abstract). And that: “As will be discussed below, the power supply 110 supplies a low intensity direct current to the electrode 35. Because the electrode 35 releases silver cations, there is a chemical reaction that occurs on the surface of the electrode involving silver and oxygen that results in a nonconductive oxide on its surface. Over the treatment period, this oxide increases the surface resistance on the electrode 35. This increased resistance requires that the power supply 110 increase the voltage applied to the electrode 35 to produce the same number of silver ions throughout the treatment period. Thus in a preferred embodiment, the power supply 110 adjusts its voltage to maintain the proper current level and hence voltage level. However, at 0.88 volts and higher, the oxide can be forced off of the electrode, which could cause blood clots, stroke and the like. Therefore, a preferred embodiment of the present invention has a voltage limit of 0.86 volts. If the power supply 110 is required to supply more than 0.86 volts, it will shut down.” (paragraph bridging cols. 8-9). FIELDS further teaches the electrode comprises silver, copper and platinum “In a preferred embodiment, the electrode 35 is an alloy comprised of 97.8 percent silver, 0.2 percent copper, and 2.0 percent platinum.” (col. 7, lines 38-41; claims 9-10)(instant claims 9, 21, 22 & 29).
Regarding claims 20 and 28, OSTRUM teaches coatings that may be applied to objects implanted in animals (Claim 1), that they may be applied to devices such as pacemakers. Outten et al. teaches that the coating may be applied to “electrostimulation and recording electrodes for cardiac and neural prostheses and treatments” (Introduction, page 33). While they do not explicitly recite humans, devices such as these are often developed and implanted into humans. A person of ordinary skill in the art would immediately recognize that these devices can be implanted into humans, and would have a reasonable expectation of success that if the article of claim 9 were implanted into a human, it would function as designed. Additionally, note that claim 20 is to an article and not to a method of using the article where human would be more relevant. Nonetheless, the article of OSTRUM and Outten et al. is capable of use in humans.
Samberg et al. teaches that: “The costs associated with the treatment of medical device and surgical site infections are a major cause of concern in the global healthcare system. To prevent transmission of such infections, a prophylactic surface system that provides protracted release of antibacterial silver ions using low intensity direct electric current (LIDC; 28 lA system current at 6 V) activation has been recently developed.” (abstract, see whole document).
Samberg et al. teaches that: “the objective of this study was to assess the biocompatibility of the prophylactic surface system that uses electrical activation as a delivery mechanism for antibacterial Ag+. Specifically, investigations of the cytotoxicity to human epidermal keratinocytes (HEK), human dermal fibroblasts (HDF) and human osteoblasts (OST), and the antibacterial efficacy to Escherichia coli and S. aureus of electrically liberated Ag+ from interdigitated silver ink electrodes at specific current and voltage levels within a range of electrical parameters previously determined to kill the bacterial strains were conducted” (p. 756, col. 2, lines 9-19). And that: “The antimicrobial surface system consists of an interdigitated pattern of alternate electrically charged positive and negative silver-based electrodes separated by an electrically resistive insulation, and activated by LIDC. The system functions on the principle of oligodynamic iontophoresis; when the surface is in contact with any conducting liquid, the LIDC in the system causes the release and diffusion of antibacterial Ag+ from the silver anodes into the liquid medium. Surfaces in healthcare environments (e.g. medical implants, surgical tools) are frequently exposed to bacteria in the form of aqueous liquid media such as blood or other body fluids. In presence of such infected media on the surface, the resulting electrically stimulated Ag+ trigger the system to self-sterilize. This surface system design and its working principle are explained in more details elsewhere.” (p. 756, col. 2, §2.1, 1st paragraph).
Finding of prima facie obviousness
Rationale and Motivation (MPEP 2142-2143)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of OSTRUM and Outten et al. because OSTRUM teaches a coating that may be applied to a pacemaker, and Outten et al. teaches a coating that is beneficial for electrostimulation, and a combination would result in composite multi-layered coating that is antibacterial, with high conductivity, chemical stability, and biocompatibility with the silver layer adhering over the surface and the columnar layer adhering to the silver layer, and further to modify the coatings to actively release silver ions, by electrical stimulation as suggseted by FIELDS, for their antimicrobial effect of self-sterilizing without causing toxicity in vivo, as suggested by Samberg et al. to reduce the high costs associated with surgical treatments. Furthermore, the silver coating of OSTRUM and the titanium nitride coating of Outten et al. are construed to be equivalents known in the art to be beneficial for coating implants. "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (MPEP § 2144.06). Thus, it is obvious to combine them to form a coating suitable for an implant.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
Claims 13, 17, 23 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over OSTRUM in view of Outten et al.; Samberg et al. and FIELDS, as applied to claims 9, 14-15, 19-22, 24-25 and 27-29 above, and further in view of Saubade et al. (“Effectiveness of titanium nitride silver coatings against Staphylococcus spp. in the presence of BSA and whole blood conditioning agents” 2019; ELSEVIER; International Biodeterioration & Biodegradation, Vol. 141, pp. 44-51) and Whitehead et al. (“Surface topography and physicochemistry of silver containing titanium nitride nanocomposite coatings,” 2010; Journal of Vacuum Science and Technology B, Vol. 28, No. 1, pp. 180-187).
Applicants Claims
Applicant claims an electrode article that is implantable in a subject, the article comprising: an electrode substrate having a surface; a bacterial layer comprising a bactericidal metal element and a titanium nitride (TiN) or zirconium nitride (ZrN) columnar microstructure, as discussed above.
Applicant claims an electrode article that is implantable in a subject, the article comprising: an electrode substrate having a surface; a bactericidal layer comprising a multilayer structure comprising: a composite layer comprising a bactericidal metal element and a first portion of a TiN or ZrN columnar microstructure, as discussed above. Applicant further claims the amount of the bactericidal metal element ranges from 5% to 18% (mol/mol) based on a total amount of metal elements in the bactericidal layer (instant claims 13 & 23). And wherein the bactericidal layer is synthesized by codeposition of the bactericidal metal element and Ti onto at least a portion of the substrate’s surface under a partial pressure of Nitrogen (instant claims 17 and 26).
Determination of the scope
and content of the prior art (MPEP 2141.01)
OSTRUM teaches use of silver-containing layers at implant surfaces, as discussed above and incorporated herein by reference.
Outten et al. teaches titanium nitride coatings for use in electrostimulation and recording electrodes, and that the coatings are porous, columnar titanium nitride coatings that exhibit high electrochemically active surface areas, a discussed above and incorporated herein by reference.
Ascertainment of the difference between
the prior art and the claims (MPEP 2141.02)
The difference between the rejected claims and the teachings of OSTRUM and Outten et al. is that these references do not expressly teach the amount of
Regarding claims 17 and 26, these claim are construed to be product-by-process claims. "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. 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) (MPEP § 2113(I)).
Nonetheless, OSTRUM teaches that the silver is deposited via a sputter deposition technique (Example 1, page 6) and that “[s]puttering of Ag is simple with a direct current (DC) power supply connected to a DC magnetron cathode” (Paragraph [0038]). OSTRUM further teaches that “[b]y mixing reactive gases (e.g., oxygen containing gases such as O2 and nitrogen containing gases such as N2) during deposition, the dissolution rate can be… modified” (Paragraph [0055]) and that “[t]his understanding provides a technique for selecting the dissolution rate and the rate of bactericidal action of the coatings” (Paragraph [0056]). Outten et al. teaches that “[f]ractal TiN films were deposited using DC reactive magnetron” (Experimental Procedures, page 33) and that “depositions were carried out in an Ar and N2 gas mixture” (Surface Morphology, page 34). It is obvious to use the method disclosed by OSTRUM and Outten et al. to deposit the coating layers disclosed therein. Thus, a product produced via the methods of claims 16 and 17 are obvious.
Regarding claim 13 and 17, Saubade et al. teaches “medical grade stainless steel substrata… coated with… titanium nitride/silver (TiN/14.94 at %Ag or TiN/19.04 at %Ag)” (Abstract, page 44, results/discussion), and that these surfaces are antibacterial (Fig. 3, page 48). These substrates comprise 14.94% or 19.04% silver (Substrate, page 45). Saubade et al. teaches that: “To the authors knowledge, the effect of a conditioning film on bacterial retention and antimicrobial activity on TiNAg, coatings, i.e., nanocomposite coatings containing silver particles in a titanium nitride matrix, has not been previously described.” [emphasis added](p. 45, col. 1, lines 12-16). And that: “Coatings were deposited onto the stainless steel coupons, (titanium nitride (TiN), titanium nitride with 14.94% silver (TiN/14.94 at.%Ag) and 19.04% (TiN/19.04 at.%Ag) using an adapted magnetron sputtering method (Whitehead et al., 2010a,b).” [emphasis added](p. 45, col. 1, §2.1).
Whitehead et al. teaches that: “Silver has also long been thought to have antimicrobial and anti-inflammatory properties being effective against a broad range of yeast, fungi, viruses, and Gram-negative and Gram positive bacteria (including methicillin-resistant Staphylococcus aureus). Combining the properties of titanium nitride with the inherent antimicrobial nature of silver particularly when present in nanocrystalline form, opens up a number of novel applications for TiN/Ag nanocomposite films in, for example, the biomedical or food processing industries
where surfaces that are durable, safe, readily clean able, and resistant to microbial contamination are required.” (p. 180, col. 2, lines 5-16). Whitehead et al. teaches that: “Titanium nitride (TiN) is a hard, wear-resistant coating material, which is widely applied to components operating in an abrasive wear environment. When codeposited with silver, the coating forms a nanocomposite structure consisting of nanoparticles of silver embedded in a TiN matrix. TiN/Ag coatings were deposited by cosputtering onto bright annealed stainless steel substrates. By control of the target powers, the silver content of the films was varied in the range of 0–16.7 at. %.” (abstract, see whole document)(instant claims 13, 17, 23, and 26).
Whitehead et al. teaches that: “To combine the properties of titanium nitride together with silver in a coating, the physical vapor deposition technique of closed field unbalanced magnetron sputtering has been used. TiN and Ag are immiscible, thus when deposited together by cosputtering from two targets, the coating forms a structure that consists of a matrix of TiN surrounding nanoparticles of silver. This occurs since during deposition titanium has a very strong affinity for nitrogen whereas silver nitride is unstable. Novel titanium nitride/silver (TiN/Ag) nanocomposite coatings were therefore deposited and analyzed using a range of surface analytical techniques to determine surface roughness, topography, and physicochemical characteristics in order to assess the effect of increased silver concentration on surface properties.” (p. 181, col. 1, 4th paragraph). Whitehead et al. teaches that: “Deposition took place in Ar–N2 atmospheres at 0.24 Pa with an Ar flow volume of 15 SCCM (SCCM denotes cubic centimeter per minute at STP). The chamber pressure was 0.23 Pa before N2 was introduced.” (p. 181, col. 2, lines 6-9)(instant claim 13).
One of ordinary skill in the art at the time of instant filing would be motivated to combine the teachings of OSTRUM, Outten et al., and Saubade et al., as OSTRUM teaches antibacterial coatings comprising silver, Outten et al. teaches the benefits of coatings comprising titanium nitride, and Saubade et al. teaches an appropriate ratio of silver to titanium nitride. Such a combination would result in an effective antibacterial composition as recognized by Saubade et al. See MPEP 2144.05 regarding obviousness of ranges and close values.
Finding of prima facie obviousness
Rationale and Motivation (MPEP 2142-2143)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize a bactericidal effective amount of silver biocide in the implant coating suggested by OSTRUM and Outten et al., to actively release silver ions, by electrical stimulation as suggseted by FIELDS, as discussed above, the bactericidal amount being in the range of ~14-19% silver, as suggested by Saubade et al. in order to effectively mitigate/prevent infection in a biocide coated implant, as Saubade et al. teaches an appropriate ratio of silver to titanium nitride, such a combination would result in an effective antibacterial composition as recognized by Saubade. See MPEP 2144.05 regarding obviousness of ranges.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
Response to Arguments:
Applicant's arguments filed 11/21/2025 have been fully considered but they are not persuasive.
Applicant argues that: “Applicant respectfully submits that none of the applied references teaches or suggests the features of amended claim 9, which recite a composite bactericidal layer comprising TiN/ZrN and Ag/Cu. The composite bactericidal layer comprises TiN or ZrN pillars, which define pores therebetween. When ions of the bactericidal metal element are released from the composite layer in response to the application of electrical potential, they enter the pores and diffuse into the bodily fluid which is in contact with the electrode article.” And “Initially, none of the applied references teaches or suggests a ZrN-based film.” (p. 8, §Third Criterion of the KSR Test).
In response the examiner argues that the rejection is based on a combination of references and claims are rejected based on obviousness under 103. Additionally, the ZrN-based film is an alternative, and not required.
Applicant argues that: “Furthermore, Ostrum describes coatings containing silver, which exert antimicrobial activity when bacteria (e.g., in a body fluid) contact the coated surface (Ostrum, Abstract). Ostrum is silent regarding a composite layer having the structure recited in amended claim 9.” And “Outten describes titanium nitride fractal coatings for cardiac and neural electrostimulation electrodes (Outten, Title and Abstract). The coatings of Outten comprise a TiN film comprising TiN pillars (Fig. 1 of Outten), but no bactericidal elements.” (p. 9, last two paragraphs). Applicant further argues that: “Samberg describes an electrically-activated silver-based antibacterial surface system comprising a silver-containing layer, which releases bactericidal silver ion in response to the application of electric potential (Samberg, Title and Abstract). Samberg is silent regarding a composite layer having the structure recited in amended claim 9, as well.” (p. 10, 3rd paragraph).
In response to applicant's arguments against the references individually, 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).
Applicant further argues that: “In addition, Outten does not show that Outten’s TiN film has pores that are large enough to allow the passage of ions of body fluids, or bactericidal ions. As described in the attached Declaration under 37 CFR 1.132 ("Declaration"), TiN films having such diffusible pores were not common knowledge at the effective filing date of the present application (Declaration, paragraphs 15-25). Indeed, the present application describes various experiments, such as imaging and cyclic voltammogram, which confirmed that TiN layers prepared according to the present application have such diffusible pores, and the cyclic voltammogram of Outten (Fig. 2 therein) indicates that the TiN films of Outten did not have such diffusible pores.” (p. 10, 1st paragraph).
In response the examiner argues that the instant claims are not limited by pore size and the recitation that: “wherein the pores of the bactericidal layer allow for released ions of the bactericidal metal to diffuse into the bodily fluid which is in contacte with the electrode article” does not limit the pore size (or, e.g., pore surface area). And no side-by-side comparative data has been provided, for example, showing specific conditions needed to achieve the porous layer different from those known in the prior art. Additionally, OSTRUM claims “An article that is implantable in an animal, the article comprising a microparticular silver-containing antimicrobial layer stably adhered upon at least one surface of the article (claim 1). And includes “a porosity sufficient to permit an antimicrobially effective amount of silver to least from the antimicrobial layer to the distal surface of the exterior layer when the article is implanted in the animal.” (claim 9). The disclosure of OSTRUM uses sputtering to produce the films of the invention including composite films ([0029], [0034], [0037]).
Applicant argues that: “As described in the Declaration, none of the applied references teaches or suggest a TiN film having pores as recited in claim 9; in fact, such structural features were not common knowledge at the effective filing date of the present application (Declaration, paragraphs 15-25). Without the knowledge provided for the first time in the present application, one of ordinary skill in the art would have been unable to prepare the composite layer of amended claim 9, and would have not be motivated to combine or modify the applied references in an attempt to achieve this composite layer.” (p. 10, §First Criterion of the KSR Test, 2nd paragraph). And that: “As commented above, without the knowledge that the pores as recited in amended claim 9 can be introduced into TiN-based layers, one of ordinary skill in the art would have had no reasonable expectation of success to modify or combining Ostrum, Outten, and Samberg to arrive at the features of amended claim 9.” (claim 11, 1st paragraph).
In response the examiner argues that OSTRUM claims “An article that is implantable in an animal, the article comprising a microparticular silver-containing antimicrobial layer stably adhered upon at least one surface of the article (claim 1). And includes “a porosity sufficient to permit an antimicrobially effective amount of silver to least from the antimicrobial layer to the distal surface of the exterior layer when the article is implanted in the animal.” (claim 9). The disclosure of OSTRUM uses sputtering to produce the films of the invention including composite films ([0029], [0034], [0037]). Outten et al. teaches the development of titanium nitride (TiN) fractal coatings for electrodes (title), the “Fractal TiN films were deposited using DC reactive magnetron sputtering from a titanium (Ti) […].” (p. 33, col. 2, 2nd paragraph). Therefore one of ordinary skill in the art would have recognized that the sputtering technique could produce a porous coating that includes “a porosity sufficient to permit an antimicrobially effective amount of silver to least from the antimicrobial layer to the distal surface of the exterior layer when the article is implanted in the animal.” (OSTRUM claim 9).
Applicant argues that: “Even if one of ordinary skill in the art would have been motivated to combine the applied reference in an attempt to obtain a bactericidal layer, they would have obtained only a multilayered structure, which is not ideal for use in an implantable device
As discussed in the Declaration, combining Ostrum, Outten, and Samberg would result only in a multilayered structure with the TiN layers of Outten on top of the silver layers of Ostrum or Samberg. Such configuration is wholly distinct from the composite layer as recited in amended claim 9 and is not suitable for use as coatings on an implantable device, because the consumption of the silver atoms would eventually cause the detachment of the TiN layer inside the patients' bodies (Declaration, paragraphs 26-29).” (p. 11, lines 11-19).
In respones the examier argues that codeposition using sputtering is clearly taught by OSTRUM, for example, see paragraph ([0034]). Additionally, both Staubade et al. and Whitehead et al. teach codeposition by sputtering (cosputtering) of silver with TiN producing a nanocomposite layer.
Applicant further argues unexpected results from the claimed compositions, particularly, “because it allows on-demand bactericidal ion release, which greatly extends the longevity of the coatings.” And that: “As described in the Declaration, the coatings as described in Ostrum has been found to be highly effective in suppressing various species of bacteria. However, their lifespans are relatively short because the elution of the silver ion from the coatings are uncontrolled and continuous. In contrast, the composite layer of amended claim 9 releases bactericidal ions only in response to the electric potential applied by the power source; as such, the ion release from the claimed electrode article is highly controllable and programmable, and can be easily configured to happen only when the need arises, resulting in much longer longevities needed for implantable devices (Declaration, paragraphs 6-9).”
In respones the examiner argues that the instant claims do not require any limitation of the lifespan of the silver ion elution nor do the claims require that: “the composite layer of amended claim 9 releases bactericidal ions only in response to the electric potential applied by the power source” [emphasis added]. While the instant claims require that: “wherein ions of the bactericidal metal element are released from the composite into the pores of the bactericidal layer in response ot the application of electrical potential” the claims not exclude passive release of silver (i.e. bactericidal metal) ions from the silver layer. Therefore, the argument is not commensurate with the claims, and is not convincincing.
Respones to Applicants §1.132 declaration filed 11/21/2025:
The examiner has fully considered Applicants declaration filed 11/21/2025 and finds the declaration not convincing because (1) the declaration does not include comparative data (side-by-side comparison with the closest prior art or closer – MPEP §716.02(e), and is considered an opinion declaration, and (2) the positions in the declaration are not considered commesurate with the rejected claims. Particularly Applicant suggests that: “In summary, the composite bactericidal layer of the present application achieves antibacterial effects similar to Ostrum, but with a much longer longevity due to the feature of on-demand ion release, which allows the release of bactericidal ions only when there is a need. This is a significant and unexpected improvement over Ostrum.” (item 14), however, the claims are not limited to compositions having “a much longer longevity due to the feature of on-demand ion release, which allows the release of bactericidal ions only when there is a need”. And is therefore a convincing basis for allowance of the instant claims.
Conclusion
Claims 9, 13-15, 17, 19-29 are pending and have been examined on the merits. Claims 9, 13-15, 17, 19-29 are rejected under 35 U.S.C. 103. No claims allowed at this time.
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/IVAN A GREENE/Examiner, Art Unit 1619
/TIGABU KASSA/Primary Examiner, Art Unit 1619