DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. 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.
Claim Rejections - 35 USC § 103
3. 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.
4. Claims 1, 3-6, 8-9, 11-14, 16-17, and 19 rejected under 35 U.S.C. 103 as being unpatentable over Brister U.S. 11,633,133 (herein referred to as “Brister”) and in view of Dickhans U.S. 11,197,715 (herein referred to as “Dickhans”).
5. Regarding Claim 1, Brister teaches a threadlike sensor (see at least Figs. 1B, 2A-2B, 7A-7B, and 10), comprising:
a. a thread core (Fig. 7A1, ref character “E1”),
b. an inner insulating layer (Fig. 7A1, ref character “I” that is immediately adjacent ref character “E1”),
c. an outside electrode layer (Fig. 7A1, ref character “E2”) and
d. an outer insulating layer (Fig. 7A1, ref character “I” that is immediately adjacent ref character “E2”),
e. wherein the inner insulating layer covers the thread core (see Figs. 7A1 and 7A2, ref character “I” adjacent to ref character “E1” covers it; Col. 48, lines 43-44, “Layers of insulating material I (e.g., non-conductive material) separate the electrode layers”) with an end of the thread core being exposed by the inner insulating layer (see Figs. 7A1 and 7A2, ref num “E1” is exposed by “I” adjacent to it on the distal end);
f. the outside electrode layer is disposed outside the inner insulating layer (see Fig. 7A1, ref character “E2” is outside of ref character “I” to the right that covers “E1”);
g. the outer insulating layer covers the outside electrode layer (see Figs. 7A1 and 7A2, ref character “I” adjacent to ref character “E2” covers it; Col. 48, lines 43-44, “Layers of insulating material I (e.g., non-conductive material) with an end of the outside electrode layer being exposed by the outer insulating layer (see Figs. 7A1 and 7A2, ref num “E2” is exposed by “I” adjacent to it on the distal end);
h. one end of the threadlike sensor is a detection end configured for placement in a human body (Col. 61, lines 16-26, “the sensor (e.g., a glucose sensor) is configured for implantation into the host. For example, the sensor may be wholly implanted into the host, such as but not limited to in the host's subcutaneous tissue (e.g., the embodiment shown in FIG. 1A). In other embodiments, the sensor is configured for transcutaneous implantation in the host's tissue. For example, the sensor can have a portion that is inserted through the host's skin and into the underlying tissue, and another portion that remains outside the host's body (e.g., such as described in more detail with reference to FIG. 1B)”; Fig. 1B);
i. the other end of the threadlike sensor is an interface end configured for external connection (Col. 61, lines 16-26, “the sensor (e.g., a glucose sensor) is configured for implantation into the host. For example, the sensor may be wholly implanted into the host, such as but not limited to in the host's subcutaneous tissue (e.g., the embodiment shown in FIG. 1A). In other embodiments, the sensor is configured for transcutaneous implantation in the host's tissue. For example, the sensor can have a portion that is inserted through the host's skin and into the underlying tissue, and another portion that remains outside the host's body (e.g., such as described in more detail with reference to FIG. 1B)”; Fig. 1B); and
j. the thread core and the outside electrode layer are configured for sensitivity testing (Abstract – “first and second working electrodes to measure additional analyte or non-analyte signal. Such measurements may provide a background and/or sensitivity measurement(s)”; Col. 2, lines 24-67 – Col. 3, lines 1-8).
Brister fails to teach two ends of the thread core being exposed by the inner insulating layer and two ends of the outside electrode layer being exposed by the outer insulating layer.
Dickhans teaches a wire of analogous art (Fig. 1), wherein the wire comprises an outside electrode layer (Fig. 1, ref num 120; Col. 7, lines 44-45, “an outer conductive braid 120”), an outer insulating layer (Fig. 1, ref nums 230 and 330; Col. 15, lines 66, “shrink tube 230, which is formed from PET”; Col. 12, line 67 – Col. 13, line 1, “choke tube 330, formed from PTFE”; it is understood that the outer insulating layer is formed by ref num 230 at the distal end and ref num 330 at the proximal end), a thread core (Fig. 1, ref num 140), and an inner insulating layer (Fig. 3, ref num 130). The outside electrode layer has two ends exposed by the outer insulating layer (Fig. 1, ref num 120 is exposed at ‘43’ breakaway and ‘48’ breakaway). By exposing the outer electrode layer, this regulates the temperature of the wire (Col. 6, lines 54-55). The thread core also has two ends exposed by the inner insulating layer (Fig. 1, ref num 140 is exposed at ref num 142 and Fig. 19, ref num 140 is exposed at ref num 144). This forms the portion of the sensor in which contacts the tissue for treatment (Col. 6, lines 47-51). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Brister to expose two ends of the outside electrode layer in order to regulate the temperature of the threadlike sensor and two ends of the thread core exposed in order to contact tissue for treatment purposes.
6. Regarding Claim 3, Brister teaches the outside electrode layer is formed by winding an outside electrode wire around the inner insulating layer (see Fig. 7B, the outside electrode layer, in this figure is ref character “E1” is wound around ref character “E2” which is coated with an inner insulating layer; Col. 49, lines 15-17). In another embodiment of Brister, the outside electrode wire is wound by at least one layer (Fig. 7K, ref num 703 is wound around ref character “E1”; Col. 66, lines 45-62, “the non-conductive material can be coated on or wrapped around the grouped or bundled electrodes… a second non-conductive material 703”). This configuration prevents direct contact between the various electrode layers (Col. 66, lines 45-62). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Brister to have the outside electrode layer configured in such a way in order to prevent direct contact between the various electrode layers.
7. Regarding Claim 4, Brister teaches the inner insulating layer is an insulating coating (Col. 49, lines 15-17, “the surfaces of the electrodes are coated with an insulator, to prevent direct contact between the electrodes”).
8. Regarding Claim 5, Brister teaches the thread core is a working electrode (Col. 49, lines 25-26, “the first electrode E1 can be a working electrode”); a specific enzyme is disposed on an outer wall surface of the working electrode (Fig. 7K, ref num 702; Col. 54, lines 10-13, “the first working electrode E1 formed within the insulator I leaving space for an enzyme. For example, an enzyme solution 702 (e.g., GOx for detecting glucose) is disposed within the space 701”); the inner insulating layer covers the specific enzyme (Col. 54, lines 10-13, “the first working electrode E1 formed within the insulator I leaving space for an enzyme. For example, an enzyme solution 702 (e.g., GOx for detecting glucose) is disposed within the space 701”); and the specific enzyme located at the detection end is exposed by the inner insulating layer (Col. 34, lines 32-41, “the membrane system includes a plurality of domains, for example, one or more of an electrode domain 24, an optional interference domain 26, an enzyme domain 28 (for example, including glucose oxidase)…the membrane system can be deposited on the exposed electroactive surfaces”; this indicates that the enzyme is exposed by the inner insulating layer).
9. Regarding Claim 6, Brister teaches the thread core is metal (Col. 54, lines 7-8, “two electrodes E1, E2 (e.g., metal wires)”) but fails to teach the thread core is a soft threadlike titanium strip or a soft threadlike gold strip.
Dickhans teaches the thread core is formed of a gold strip (Col. 7, lines 50-51), “The inner conductor 140 is formed of a solid conductive material (e.g., copper, stainless steel, silver, gold…)”). It would have been obvious to one having ordinary skill in the art at the time the invention was made to have the thread core formed of a soft threadlike gold strip, 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.
10. Regarding Claim 8, Brister teaches the thread core is a working electrode (Col. 49, lines 25-26, “the first electrode E1 can be a working electrode”) and the outside electrode layer is a counter electrode (Col. 49, lines 26-28, “the second electrode E2 can be a reference or auxiliary electrode”).
11. Regarding Claim 9, Brister teaches a wearable device (Col. 67, lines 26-30, “in the case of a transcutaneous sensor, the reference and/or counter electrodes can be located on the ex vivo portion of the sensor or reside on the host's skin, such as a portion of an adhesive patch”) comprising a wearing unit provided with the threadlike sensor (Figs. 1A and 1B) provided with the threadlike sensor according to claim 1 (see Claim 1 rejection above).
12. Regarding Claim 11, Brister teaches the outside electrode layer is formed by winding an outside electrode wire around the inner insulating layer (see Fig. 7B, the outside electrode layer, in this figure is ref character “E1” is wound around ref character “E2” which is coated with an inner insulating layer; Col. 49, lines 15-17). In another embodiment of Brister, the outside electrode wire is wound by at least one layer (Fig. 7K, ref num 703 is wound around ref character “E1”; Col. 66, lines 45-62, “the non-conductive material can be coated on or wrapped around the grouped or bundled electrodes… a second non-conductive material 703”). This configuration prevents direct contact between the various electrode layers (Col. 66, lines 45-62). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Brister to have the outside electrode layer configured in such a way in order to prevent direct contact between the various electrode layers.
13. Regarding Claim 12, Brister teaches the inner insulating layer is an insulating coating (Col. 49, lines 15-17, “the surfaces of the electrodes are coated with an insulator, to prevent direct contact between the electrodes”).
14. Regarding Claim 13, Brister teaches the thread core is a working electrode (Col. 49, lines 25-26, “the first electrode E1 can be a working electrode”); a specific enzyme is disposed on an outer wall surface of the working electrode (Fig. 7K, ref num 702; Col. 54, lines 10-13, “the first working electrode E1 formed within the insulator I leaving space for an enzyme. For example, an enzyme solution 702 (e.g., GOx for detecting glucose) is disposed within the space 701”); the inner insulating layer covers the specific enzyme (Col. 54, lines 10-13, “the first working electrode E1 formed within the insulator I leaving space for an enzyme. For example, an enzyme solution 702 (e.g., GOx for detecting glucose) is disposed within the space 701”); and the specific enzyme located at the detection end is exposed by the inner insulating layer (Col. 34, lines 32-41, “the membrane system includes a plurality of domains, for example, one or more of an electrode domain 24, an optional interference domain 26, an enzyme domain 28 (for example, including glucose oxidase)…the membrane system can be deposited on the exposed electroactive surfaces”; this indicates that the enzyme is exposed by the inner insulating layer).
15. Regarding Claim 14, Brister teaches the thread core is metal (Col. 54, lines 7-8, “two electrodes E1, E2 (e.g., metal wires)”) but fails to teach the thread core is a soft threadlike titanium strip or a soft threadlike gold strip.
Dickhans teaches the thread core is formed of a gold strip (Col. 7, lines 50-51), “The inner conductor 140 is formed of a solid conductive material (e.g., copper, stainless steel, silver, gold…)”). It would have been obvious to one having ordinary skill in the art at the time the invention was made to have the thread core formed of a soft threadlike gold strip, 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.
16. Regarding Claim 16, Brister teaches the thread core is a working electrode (Col. 49, lines 25-26, “the first electrode E1 can be a working electrode”) and the outside electrode layer is a counter electrode (Col. 49, lines 26-28, “the second electrode E2 can be a reference or auxiliary electrode”).
17. Regarding Claim 17, Brister teaches a method for fabricating a threadlike sensor (see at least Figs. 1B, 2A-2B, 7A-7B, and 10), comprising the following steps:
a. disposing an inner insulating layer (Fig. 7A1, ref character “I” that is immediately adjacent ref character “E1”) outside a thread core (Fig. 7A1, ref character “E1”) such that the inner insulating layer covers the thread core (see Figs. 7A1 and 7A2, ref character “I” adjacent to ref character “E1” covers it; Col. 48, lines 43-44, “Layers of insulating material I (e.g., non-conductive material) separate the electrode layers”) and an end of the thread core being exposed by the inner insulating layer (see Figs. 7A1 and 7A2, ref num “E1” is exposed by “I” adjacent to it on the distal end);
b. disposing an outside electrode layer (Fig. 7A1, ref character “E2”) outside the inner insulating layer (see Fig. 7A1, ref character “E2” is outside of ref character “I” to the right that covers “E1”); and
c. disposing an outer insulating layer (Fig. 7A1, ref character “I” that is immediately adjacent ref character “E2”) outside the outside electrode layer such that the outer insulating layer covers the outside electrode layer (see Figs. 7A1 and 7A2, ref character “I” adjacent to ref character “E2” covers it; Col. 48, lines 43-44, “Layers of insulating material I (e.g., non-conductive material) and an end of the outside electrode layer being exposed by the outer insulating layer (see Figs. 7A1 and 7A2, ref num “E2” is exposed by “I” adjacent to it on the distal end
Brister fails to teach two ends of the thread core being exposed by the inner insulating layer and two ends of the outside electrode layer being exposed by the outer insulating layer.
Dickhans teaches a method of analogous art (Fig. 1), wherein the wire comprises an outside electrode layer (Fig. 1, ref num 120; Col. 7, lines 44-45, “an outer conductive braid 120”), an outer insulating layer (Fig. 1, ref nums 230 and 330; Col. 15, lines 66, “shrink tube 230, which is formed from PET”; Col. 12, line 67 – Col. 13, line 1, “choke tube 330, formed from PTFE”; it is understood that the outer insulating layer is formed by ref num 230 at the distal end and ref num 330 at the proximal end), a thread core (Fig. 1, ref num 140), and an inner insulating layer (Fig. 3, ref num 130). The outside electrode layer has two ends exposed by the outer insulating layer (Fig. 1, ref num 120 is exposed at ‘43’ breakaway and ‘48’ breakaway). By exposing the outer electrode layer, this regulates the temperature of the wire (Col. 6, lines 54-55). The thread core also has two ends exposed by the inner insulating layer (Fig. 1, ref num 140 is exposed at ref num 142 and Fig. 19, ref num 140 is exposed at ref num 144). This forms the portion of the sensor in which contacts the tissue for treatment (Col. 6, lines 47-51). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Brister to expose two ends of the outside electrode layer in order to regulate the temperature of the threadlike sensor and two ends of the thread core exposed in order to contact tissue for treatment purposes.
18. Regarding Claim 19, Brister as modified teaches a method of claim 17, as well as each of the inner insulating layer, outside electrode layer, and outer insulating layer is one of a coating and a plating (Col. 33, lines 34-39, “one or more electrodes are covered with an insulating material, for example, a non-conductive polymer. Dip-coating, spray-coating, vapor-deposition, or other coating or deposition techniques can be used to deposit the insulating material on the electrode(s)”; Col. 32, lines 49-50, “it can be advantageous to form the electrodes from plated wire”):
a. disposing the inner insulating layer (Fig. 7A1, ref character “I” that is immediately adjacent ref character “E1”) outside the thread core (Fig. 7A1, ref character “E1”) such that the inner insulating layer covers the thread core (see Figs. 7A1 and 7A2, ref character “I” adjacent to ref character “E1” covers it; Col. 48, lines 43-44, “Layers of insulating material I (e.g., non-conductive material) separate the electrode layers”);
b. disposing the outside electrode layer (Fig. 7A1, ref character “E2”) outside the inner insulating layer (see Fig. 7A1, ref character “E2” is outside of ref character “I” to the right that covers “E1”); and
c. disposing the outer insulating layer (Fig. 7A1, ref character “I” that is immediately adjacent ref character “E2”) outside the outside electrode layer such that the outer insulating layer covers the outside electrode layer (see Figs. 7A1 and 7A2, ref character “I” adjacent to ref character “E2” covers it; Col. 48, lines 43-44, “Layers of insulating material I (e.g., non-conductive material) and an end of the outside electrode layer being exposed by the outer insulating layer (see Figs. 7A1 and 7A2, ref num “E2” is exposed by “I” adjacent to it on the distal end).
Brister fails to teach removing a first flexible film and second flexible film to expose the two ends of the thread core by the inner insulating layer and the two ends of the outside electrode layer by the outer insulating layer.
Dickhans teaches a method of analogous art (Fig. 1), wherein the wire comprises an outside electrode layer (Fig. 1, ref num 120; Col. 7, lines 44-45, “an outer conductive braid 120”), an outer insulating layer (Fig. 1, ref nums 230 and 330; Col. 15, lines 66, “shrink tube 230, which is formed from PET”; Col. 12, line 67 – Col. 13, line 1, “choke tube 330, formed from PTFE”; it is understood that the outer insulating layer is formed by ref num 230 at the distal end and ref num 330 at the proximal end), a thread core (Fig. 1, ref num 140), and an inner insulating layer (Fig. 3, ref num 130). The outside electrode layer has two ends exposed by the outer insulating layer (Fig. 1, ref num 120 is exposed at ‘43’ breakaway and ‘48’ breakaway). This is done by removing a length of the inner insulating layer (Col. 11, lines 2-4, “the length L9 of the dielectric is then removed or stripped to expose the inner conductor 140 along the length L9” this is known as the first flexible film) and removing a length of the outer insulating layer (Col. 14, lines 55-56, “The choke tube 330 is trimmed back a length L.sub.330 from the end 144”; this is known as the second flexible film). By exposing the outer electrode layer, this regulates the temperature of the wire (Col. 6, lines 54-55). The thread core also has two ends exposed by the inner insulating layer (Fig. 1, ref num 140 is exposed at ref num 142 and Fig. 19, ref num 140 is exposed at ref num 144). This forms the portion of the sensor in which contacts the tissue for treatment (Col. 6, lines 47-51). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Brister to expose two ends of the outside electrode layer in order to regulate the temperature of the threadlike sensor and two ends of the thread core exposed in order to contact tissue for treatment purposes.
19. Claims 2, 10, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Brister and Dickhans, and further in view of Salahieh U.S. 2017/0042614 (herein referred to as “Salahieh”).
20. Regarding Claim 2, Brister teaches that the conductive and insulative layers are arranged in a coaxial configuration such as a cylinder surrounding one another (see Figs. 7A1 and 7A2). However, Brister fails to teach an inner insulating wire is wound around the thread core to form the inner insulating layer, and the inner insulating wire is wound by at least one layer; and/or an outer insulating wire is wound around the outside electrode layer to form the outer insulating layer, and the outer insulating wire is wound by at least one layer.
Salahieh teaches a threadlike sensor of analogous art (Figs. 33A-33B; para 0192, “mapping electrodes can be used, for example, to sense”), wherein the sensor comprises a core (Figs. 33A and 33B, ref num 74) and an insulating layer (Fig. 33A, ref num 75), such that the insulating layer is formed by an insulating wire (para 0203, “mapping electrode structure includes a mapping wire”) wound around the core (Fig. 33B, ref num 75 is a wire wound around ref num 74; para 0203, “an insulated coil 75 of a non-conductive material can be wound around the inner assembly”). The insulating wire is wound by at least one layer (see Fig. 33B, ref num 96 is at certain intervals). This creates the conductive sections in order to provide the sensing function (para 0203). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Brister to have either the outer or inner insulating layer be wound around its respective electrode layer, as this configuration provides the expected result of sensing the target.
21. Regarding Claim 10, Brister teaches that the conductive and insulative layers are arranged in a coaxial configuration such as a cylinder surrounding one another (see Figs. 7A1 and 7A2). However, Brister fails to teach an inner insulating wire is wound around the thread core to form the inner insulating layer, and the inner insulating wire is wound by at least one layer; and/or an outer insulating wire is wound around the outside electrode layer to form the outer insulating layer, and the outer insulating wire is wound by at least one layer.
Salahieh teaches a threadlike sensor of analogous art (Figs. 33A-33B; para 0192, “mapping electrodes can be used, for example, to sense”), wherein the sensor comprises a core (Figs. 33A and 33B, ref num 74) and an insulating layer (Fig. 33A, ref num 75), such that the insulating layer is formed by an insulating wire (para 0203, “mapping electrode structure includes a mapping wire”) wound around the core (Fig. 33B, ref num 75 is a wire wound around ref num 74; para 0203, “an insulated coil 75 of a non-conductive material can be wound around the inner assembly”). The insulating wire is wound by at least one layer (see Fig. 33B, ref num 96 is at certain intervals). This creates the conductive sections in order to provide the sensing function (para 0203). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Brister to have either the outer or inner insulating layer be wound around its respective electrode layer, as this configuration provides the expected result of sensing the target.
22. Regarding Claim 18, Brister as modified teaches the method of Claim 17, as well as the outside electrode layer is formed by winding an outside electrode wire around the inner insulating layer (see Fig. 7B, the outside electrode layer, in this figure is ref character “E1” is wound around ref character “E2” which is coated with an inner insulating layer; Col. 49, lines 15-17). In another embodiment of Brister, the outside electrode wire is wound by at least one layer (Fig. 7K, ref num 703 is wound around ref character “E1”; Col. 66, lines 45-62, “the non-conductive material can be coated on or wrapped around the grouped or bundled electrodes… a second non-conductive material 703”). This configuration prevents direct contact between the various electrode layers (Col. 66, lines 45-62). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Brister to have the outside electrode layer configured in such a way in order to prevent direct contact between the various electrode layers.
Brister also teaches that the conductive and insulative layers are arranged in a coaxial configuration such as a cylinder surrounding one another (see Figs. 7A1 and 7A2). However, Brister fails to teach an inner insulating wire is wound around the thread core to form the inner insulating layer, and the inner insulating wire is wound by at least one layer; and an outer insulating wire is wound around the outside electrode layer to form the outer insulating layer, and the outer insulating wire is wound by at least one layer.
Salahieh teaches a threadlike sensor of analogous art (Figs. 33A-33B; para 0192, “mapping electrodes can be used, for example, to sense”), wherein the sensor comprises a core (Figs. 33A and 33B, ref num 74) and an insulating layer (Fig. 33A, ref num 75), such that the insulating layer is formed by an insulating wire (para 0203, “mapping electrode structure includes a mapping wire”) wound around the core (Fig. 33B, ref num 75 is a wire wound around ref num 74; para 0203, “an insulated coil 75 of a non-conductive material can be wound around the inner assembly”). The insulating wire is wound by at least one layer (see Fig. 33B, ref num 96 is at certain intervals). This creates the conductive sections in order to provide the sensing function (para 0203). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Brister to have both the outer and inner insulating layer be wound around its respective electrode layer, as this configuration provides the expected result of sensing the target.
23. Claims 7 and 15 rejected under 35 U.S.C. 103 as being unpatentable over Brister and Dickhans, and further in view of Advances of Prussian blue and its analogues in (bio)sensors by A.A. Karaykin (herein referred to as “Karaykin”).
24. Regarding Claim 7, Brister teaches the thread core is a working electrode (Col. 49, lines 25-26, “the first electrode E1 can be a working electrode”).
Brister fails to teach the thread core comprises an insulating inner core and a Prussian blue-graphite paste layer covering the insulating inner core.
However, Karyakin teaches that the use of a Prussian blue-graphite paste layer covering an insulating inner core would provide the advantage of improving sensitivity, selectivity, and operational stability of the sensor (Section Prussian blue-based biosensors – “Biosensors based on Prussian blue are extremely attractive due to remarkably improved selectivity… The dramatically improved sensitivity, selectivity and operational stability were observed for glucose and lactate biosensors”). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Brister to have an insulating inner core that is cover by a Prussian blue-graphite paste layer in order to improve the sensitivity and stability of the sensor when perform the diagnostic testing.
25. Regarding Claim 15, Brister teaches the thread core is a working electrode (Col. 49, lines 25-26, “the first electrode E1 can be a working electrode”).
Brister fails to teach the thread core comprises an insulating inner core and a Prussian blue-graphite paste layer covering the insulating inner core.
However, Karyakin teaches that the use of a Prussian blue-graphite paste layer covering an insulating inner core would provide the advantage of improving sensitivity, selectivity, and operational stability of the sensor (Section Prussian blue-based biosensors – “Biosensors based on Prussian blue are extremely attractive due to remarkably improved selectivity… The dramatically improved sensitivity, selectivity and operational stability were observed for glucose and lactate biosensors”). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Brister to have an insulating inner core that is cover by a Prussian blue-graphite paste layer in order to improve the sensitivity and stability of the sensor when perform the diagnostic testing.
Conclusion
26. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNIE L SHOULDERS whose telephone number is (571)272-3846. The examiner can normally be reached Monday-Friday (alternate Fridays) 8AM-5PM EST.
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, Joseph Stoklosa can be reached at 571-272-1213. 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.
/ANNIE L SHOULDERS/Examiner, Art Unit 3794