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 .
Response to Amendment
The Amendment filed November 06, 2025 has been entered. Currently, claims 20-23 have been newly added, and claims 1-17, 19-23 are pending in the application.
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.
Claims 13-17, 20-23 are rejected under 35 U.S.C. 103 as being unpatentable over Say (U.S. Patent No. 7003340 B2), and further in view of Kempf (U.S. Application No. 20120194981 A1).
Regarding claims 13 and 17, Say discloses a medical electrode (42), comprising (Col. 6, lines 36-44 & Fig. 2);
an electrically insulating substrate material, comprising a ceramic (50) (Col. 7, lines 14-16; Co. 7, lines 66-67 – Col. 8, line 1); and
a plurality of conductor tracks (52) (Col. 7, lines 29-31);
wherein the smallest distance between two adjacent conductor tracks (Col. 12, lines 57-59) is smaller or larger than the height of one of the two conductor tracks (Col. 12, lines 49-53; the claim does not define the direction of the height of the conductor tracks, therefore the length of the conductor extending along the direction, as shown by the arrow in the annotated figure 3A below, is being interpreted by the examiner as the height).
wherein the distance and the height are defined along a common axis (the distance between the two adjacent conductor tracks 52 and the length of the conductor tracks as defined above extend along the annotated axis as shown below).
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wherein the substrate material includes depressions (54) that are cut to less than their entire depth (Col. 10, lines 44-48 & Figs. 3A-3B); and filled with a conductive material (56); and
wherein the conductive material inside the depressions are formed on the insulating substrate by a variety of techniques, including, for example, photolithography, screen printing, or other impact or non-impact printing techniques (Col. 10, lines 35-38).
However, Say does not disclose conductor tracks comprising a cermet material, and wherein the depressions are subsequently sintered such that the ceramic material from the cermet forms a continuous ceramic material with the ceramic of the substrate and such that the ceramic material of the substrate and from the cermet comprises grains which are continuously connected to each other.
Kempf, in the same field of endeavor, teaches a medical electrode for sensing and stimulating body tissue (pa. 0036), while it is not for sensing an analyte or a biomolecule, the structure is analogous to Say, and they both are capable of transmitting sensed signal/information from a patient to a medical device. Kempf further teaches the medical device comprising a housing (20) with a ceramic region (23), and a conductive element/conductor (110, pa. 0136 & Fig. 1) made fully or partly of at least one cermet material (pa. 0067 , 0073) due to their high toughness and wear resistance (pa. 0081, 0095). The ceramic region of the housing and the conducting elements are sintered jointly in order to attain hermetic sealing (pa. 0138), thereby creating a by-product in which the ceramic of the substrate housing and the cermet comprise grains which are continuously connected to each other.
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 have modified the material of the conductor track of Say in order to incorporate cermet due to their high toughness and wear resistance, and it would have been obvious to connect the ceramic material of the substrate to the ceramic of the cermet in order to create a hermetic seal.
Regarding claims 14-16, Say/Kempf combination discloses wherein the distance between two adjacent conductor tracks is smaller than 100 um, smaller than 70 um, and smaller than 50 um (Say, Col. 12, lines 57-59).
Regarding independent claim 20 and claim 22, Say discloses a medical electrode (42), comprising (Col. 6, lines 36-44 & Fig. 2);
an electrically insulating substrate material (50), comprising a first ceramic material (i.e., aluminum oxide) (Col. 7, lines 14-16; Col. 8, lines 26-29), the substrate material defining a depression (54) that does not extend through a full thickness of the substrate material (Col. 10, lines 44-48 & Figs. 3A-3B); and
a conductor track (52) (Col. 7, lines 29-31) arranged in the depression, the conductor track comprising a conductive material (56) (Col. 10, lines 44-48).
Examiner notes that the conductive material which fills the depressions is formed using a precursor material, such as a conductive ink or paste (Col. 10, lines 66-67 – Col. 11, line 1), wherein the conductive ink contains a binder (e.g., polyurethane resins; known for its hermetic sealing properties since it provides an excellent barrier against moisture and environmental damages) which is cured to further bind the conductive material within the depression and/or on the substrate (Col. 11, lines 20-24 and lines 29-31).
However, Say does not disclose the conductor track comprising a cermet, wherein the cermet itself comprises a second ceramic material and a metallic component, nor wherein an interface between the substrate material and the conductor track comprises a continuous, monolithic ceramic matrix formed from the first ceramic material and the second ceramic material, such that grains of the first ceramic material and grains of the second ceramic material are continuously connected to each other, nor wherein the first ceramic material and the second ceramic material are the same.
Kempf, in the same field of endeavor, teaches a medical electrode for sensing and stimulating body tissue (pa. 0036), while it is not for sensing an analyte or a biomolecule, the structure is analogous to Say, and they both are capable of transmitting sensed signal/information from a patient to a medical device. Kempf further teaches the medical device comprising a housing (20) with a ceramic region (23) made of a ceramic material such as aluminum oxide (pa. 0070), and a conductive element/conductor (110, pa. 0136 & Fig. 1) made fully or partly of at least one cermet material (pa. 0067 , 0073) due to their high toughness and wear resistance (pa. 0081, 0095), wherein the cermet itself comprises a second ceramic material (e.g., aluminum oxide) and a metallic component (e.g., platinum) (pa. 0082-0083). The ceramic region of the housing and the conducting elements are sintered jointly in order to attain hermetic sealing (pa. 0138), thereby creating a continuous, monolithic ceramic matrix by-product in which the ceramic of the substrate housing and the ceramic of the cermet comprise grains which are continuously connected to each other.
Examiner notes that the sintering process between ceramic components of the same material is designed to create a single, monolithic unit since the process causes the atoms to diffuse across the boundaries of the original particles or components, fusing them together into one solid, dense mass. As particles bond, the contact points grow and become grain boundaries, (i.e., interfaces between adjacent grains within the new, unified structure) and this results in a physically and chemically continuous, strong, and durable solid structure, referred to as a monolithic ceramic.
Therefore, 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 have substituted the conductive material of the conductor track of Say with the cermet material of Kempt due to their high toughness and wear resistance, and also it would have been obvious to have incorporated the sintering manufacturing process between the two ceramic materials in order to create a true hermetic seal.
Regarding claim 21, Say/Kempf combination discloses wherein the distance between two adjacent conductor tracks is smaller than 100 um (Say, Col. 12, lines 57-59).
Regarding claim 23, Say/Kempf combination discloses comprising several electrode segments (58, 60, 62) which are each connected in an electrically conducting manner to different conductor tracks (Say, See Fig. 2).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Say and Kempf, as applied to claim 13 above, and further in view of Rodriguez (U.S. Application No. 20080140156 A1).
Regarding claim 19, Say/Kempf combination discloses the invention substantially as claimed in claim 13 discussed above.
However, they do not teach several electrode segments which are each connected in an electrically conducting manner to different conductor tracks.
Rodriguez, in the same field of endeavor, teaches electrode segments connected to different conductor tracks (pa. 0051 & Fig. 1).
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 have modified the medical electrode of Broderick to the separate electrode connections for the purpose of electrically isolating each component (Rodriguez, pa. 0055).
Response to Arguments
Applicant’s arguments, filed 11/06/2025, with respect to the 103 rejection of claim 13 under Say in view of Kempf have been fully considered but are not persuasive.
With regards to claim 13, Applicant argues that the previous Office Action has failed to provide any articulated reasoning or rational underpinning as to why a person of ordinary skill in the art would have been motivated to combine the teachings of the Say and Kempf references to arrive at the claimed invention with a reasonable expectation of success. Specifically, Applicant contends the use of improper hindsight since there is no motivation in the Say reference to provide a hermetic seal since the only reason the Kempf reference teaches such sealing practices is to prevent connection between the interior surfaces with the exterior surfaces of the medical implant. However, Examiner, respectfully disagrees.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). In this case, the Say reference discloses an implantable analyte sensor (42) for the in vivo and/or in vitro determination of an analyte, such as glucose, lactate, or oxygen, in a fluid (Col. 5, lines 4-6). The sensor comprises a ceramic substrate (50) and a plurality of conductor tracks (52), wherein the tracks are formed on the substrate using recessed channels/depressions (54) filled with a conductive material (56) (Col. 10, lines 44-48). The conductive material which fills the depressions is often formed using a precursor material, such as a conductive ink or paste (Col. 10, lines 66-67 – Col. 11, line 1), wherein the conductive ink may also contain a binder (e.g., polyurethane resins; known for its hermetic sealing properties since it provides an excellent barrier against moisture and environmental damages) which is cured to further bind the conductive material within the depressions and/or on the substrate (Col. 11, lines 20-24 and lines 29-31). Hence, the conductive material which fills the depressions provides a sealing/encapsulating function that is necessary for the proper performance of the sensor of Say since it is implanted in wet/fluid environments.
The Kempf reference teaches a medical device with a conductive element (110) comprising a cermet material and a housing (20) comprising a ceramic region (23) (pa. 0067 and 0136). The ceramic region and the conducting element are sintered jointly by forming a media-tight firmly bonded connection between the two ceramic-containing materials of the conducting element and of the housing (pa. 0138).It would have been obvious to one of ordinary skill in the art to have substituted/modified the conductive material which fills the depressions of Say with the conductive element comprising the cermet material of Kempf since they both would yield to a type of hermetic sealing between the substrate and the conductive tracks. Therefore, Examiner maintains the rejection based on the combination of Say and Kempf set-forth above.
With regards to newly added claims 20-23, Applicant argues that none of the art of record, individually or combined, teaches or suggests the claimed structure. Particularly, Applicant asserts that the method of curing ink in a channel in the Say reference would only create a mechanical interface, not a continuous, monolithic ceramic matrix, and the Kempf reference provides no motivation to create such a structure within a blind depression, as its teachings are specific to through-holes. However, Examiner disagrees.
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). In this case, Examiner only utilized the Say reference to teach the electrode comprising a ceramic substrate, a plurality of conductor tracks, and depressions filled with conductive material (see Office Action above). Examiner agrees that Say does not teach a continuous, monolithic ceramic matrix, therefore the Kempf reference is implemented to cure such and only deficiencies. Kempf teaches a conductive element comprising a cermet material and a housing comprising a ceramic region (see action above), wherein both the ceramic region of the housing and the ceramic component of the cermet consist of aluminum oxide (pa. 0070, 0082). This allows for a sintering bonding process to occur between the two ceramics (pa. 0138). The sintering process between ceramic components of the same material is designed to create a single, monolithic unit since the process causes the atoms to diffuse across the boundaries of the original particles or components, fusing them together into one solid, dense mass. As particles bond, the contact points grow and become grain boundaries, (i.e., interfaces between adjacent grains within the new, unified structure) and this results in a physically and chemically continuous, strong, and durable solid structure, referred to as a monolithic ceramic.
As already described above, the specific structural arrangement (i.e. , the through-hole configuration) of the medical device of the Kempf reference is not used in the rejection. Rather, only the composition of the conductive material (i.e., cermet) of Kempt is used to substitute the conductive material taught in Say, and the specific sintering manufacturing process between the ceramic of the cermet material and the ceramic of the substrate of Kempt is incorporated into the bond between the conductive material (i.e., now modified to the cermet material of Kempf) and the ceramic substrate of Say in order to create a true hermetic seal.
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.
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/A.V.G./Examiner, Art Unit 3794
/Ronald Hupczey, Jr./Primary Examiner, Art Unit 3794