DETAILED ACTION
Specification
The disclosure is objected to because of the following informalities: The specifications repeatedly refer to the same reference character 211 as the “distal end” or “proximal end” in different areas. For example, in [0027] of the printed publication, 211 is defined as the proximal end while in [0029] it’s defined as the distal end. In order for the specifications to provide support for claim 8, the distal end should be 212.
Appropriate correction is required.
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.
Claim(s) 1, 5-7, and 9-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Boock (US 2023/0008671) in view of Brister (US 2006/0016700).
As to claim 1, Boock teaches an invasive (0088)) multi-electrode electrochemical sensor ([0005], [0054]), comprising: a substrate ([0063] – support sheet; a plurality of wire electrodes (wire 310), wherein each said wire electrode comprises an electrically conductive core (conductive wire core 330) and an insulating sheath (320), each said insulating sheath substantially covers a corresponding one of the electrically conductive cores while exposing a proximal end and a distal end of the corresponding one of the electrically conductive cores ([0064] – insulation having a portion of its end removed to form a flat surface 340; [0095] – sensor wires 2701 attached to the PCB-style contacts), each said wire electrode has a substrate section (Fig. 36A – wire 3328 covered by wire guide 3334) and an invasion section (wire 3328 on the opposite end), the proximal end and the distal end of the electrically conductive core of each said wire electrode are located at the substrate section and the invasion section of the each said wire electrode respectively (Fig. 36A), the substrate section of each said wire electrode is provided on the substrate, the invasion section of each said wire electrode extends outward from an edge of the substrate (Fig. 36A), wherein the distal end of at least one of the electrically conductive cores is made of a material different from that of the other portion of the electrically conductive core ([0064] – a carbon or carbon/graphene/pyrrole sheet is placed on the partially removed core, and thus this portion of the core is made of a material different than that of the other portion of the electrically conductive core).
Boock does not expressly teach the invasion sections of the wire electrodes are at least partially wound around one another in a spiral manner. Brister teaches an electrochemical analyte sensor in which the various electrodes can be formed in double, triple, quad, etc helix configurations along its length, e.g. surrounding a reference electrode ([0182]). It would have been obvious to modify Boock with Brister to utilize an electrode configuration that is known to work as it would be obvious to try.
As to claims 5-7, Boock teaches the diameters for each of the sensor wires may be, for example, from 0.002 inches to 0.007 inches (~50.8 to ~177.8 microns). It is noted that the “core” portion of such a wire would be even less than that lower range (Fig. 3). Similarly, Brister teaches that each electrode is formed from a fine wire with a diameter of from about 0.001 or less to about 0.010 inches or more (~25.4 to ~254 microns). It would have been a matter of routine optimization to derive at a range recited in one of the claims in the absence of any recited criticality, particularly when, across the 3 claims, the collective range of recited diameters is effectively from 0 to infinite.
As to claim 9, Boock teaches a cover plate provided on the substrate such that the substrate sections of the wire electrodes are at least partially fixed between the cover plate and the substrate ([0120] - protrusion 3350 which is situated such that the wire is between the opening and the protrusion).
As to claim 10, Boock teaches a length for which each of the invasion sections extends outward from the edge is greater than 10 mm ([0113] – sensor is implanted 6 to 10 mm underneath the skin – since some portion of the invasion section does not fully get implanted, the total length must be greater than 10 mm).
Claim(s) 2-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Boock (US 2023/0008671) in view of Brister (US 2006/0016700), and further in view of Neel et al. (US 2005/0045476).
As to claim 2, Boock teaches a plurality of gold fingers provided on the substrate, wherein the electrically conductive core in the substrate section of each said wire electrode is electrically connected to a corresponding one of the gold fingers ([0095] – sensor wires attached to the PCB-style contacts; [0108] – contacts with gold-plating in its opening). The above combination fails to expressly teach that at least a part of the gold fingers is printed on the substrate by screen printing. Neel teaches a system for blood glucose sensing in which electrical contacts are formed by screen-printing conductive ink onto a base layer ([0065]). It would have been obvious to modify the above combination with Neel to utilize a common manufacturing process to form electrical contacts as it would be obvious to try.
As to claim 3, Boock teaches the proximal ends of the wire electrodes are electrically connected to the gold fingers, respectively (Fig. 36A).
As to claim 4, Boock teaches the proximal ends of the wire electrodes are welded to the gold fingers, respectively ([0095]).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Boock (US 2023/0008671) in view of Brister (US 2006/0016700), and further in view of Wilson et al. (US 2003/0104119).
As to claim 8, the above combination fails to teach the distal end of each electrically conductive core is sunken into an end face of the corresponding insulating sheath while satisfying the relationship Hw/Ø < 50, where Hw is a depth to which the distal end is sunken into the end face and Ø is a diameter of the electrically conductive cores. Wilson teaches a sensor made from a wire in which one end of a Teflon-coated Pt wire was stripped over 1 mm length to expose the metal surface 12 as a sensing cavity 14 by scribing a circular cut in the coating and then sliding the Teflon out to create a cavity of 1 mm in length, with the area of the exposed wire was 0.534 mm2 ([0083]). Hw = 1000 microns, diameter = 170 microns, thus ratio is 5.9 or under 50. It would’ve been obvious to modify the above combination with Wilson to recess each distal end below the sheath end face as it was a known way to create an electroactive area that is known to be usable as an electrochemical sensor.
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CHRISTIAN JANG
Primary Examiner
Art Unit 3791
/CHRISTIAN JANG/Primary Examiner, Art Unit 3791 8/24/26
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