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 .
Status of Claims
Claims 1-21 are rejected.
Response to Arguments
Claim Rejections - 35 USC § 103
Applicant's arguments filed 12/23/25 have been fully considered but they are not persuasive.
Applicant asserts that Kinast does not disclose the claimed leadset comprising one galvanic patient connector and at least two capacitive connectors and a capacitive patient lead that capacitively connects a patient to the data acquisition device. Kinast was relied upon to teach at least a first capacitive patient connector and a second capacitive patient connector (col. 3 and lines 64-65-cable splits into the individual leadwires, which in turn connect to the individual electrodes; col. 4 and lines 7-8-the leadwires may add additional shunt capacitance), wherein each capacitive patient connector is configured to capacitively couple a respective receiving port of the data acquisition device and the patient (col. 3 and lines 61-65-the trunk portion of the cable spans from the monitoring instrument to the immediate proximity of the patient. At this point, in a fixture often referred to as the yoke, the trunk cable splits into the individual leadwires, which in turn connect to the individual electrodes; col. 4 and lines 43-45-the wires W1 and W2 represent a portion of an ECG cable, each possessing a capacitance). Newly applied reference Fuwamoto is being relied upon to teach the galvanic patient connector configured to galvanically connect a first receiving port of the data acquisition device and the patient (¶12-the direct electrode contacts a skin of the occupant; ¶29-the direct electrode 10 is connected to a ground terminal 60; Fig. 1).
Applicant asserts that the combination of Barua and Antrag does not teach any capacitive leadwire that comprises a capacitor configured to capacitively transmit the physiological signals. However, Barua teaches wherein the capacitive leadwire comprises a capacitor configured to capacitively transmit the physiological signals (col. 17 and lines 30-32-for each lead, comprise a pair of boot strapped capacitors (C1 250 for the first lead, and C2 255 for the second lead); col. 17 and lines 24-27-leads transmit the physiological signal from the electrodes or sensors (not shown) attached to the subject, and into the acquisition circuitry comprising a series of electrical components). The reference clearly teaches leads having capacitors and the leads transmitting the physiological signal to acquisition circuitry.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
data acquisition device in claims 1, 6, 10-11, 13, 15, and 18.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
For “data acquisition device” in claims 1, 6, 10-11, 13, 15, and 18, the specification recites “the data acquisition device 6 is a combined respiration monitor and ECG monitor” (¶25) and “the data acquisition device 6 may be any type of physiological monitoring device involving electrodes to the patient” (¶27). The Examiner is interpreting the data acquisition device to be a respiration monitor and an ECG monitor or any type of physiological monitoring device involving electrodes to the patient.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-5, 11-12, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Kinast (US 6377845 filed on 7/25/00 as cited in the IDS) in view of Fuwamoto (US 20130261477 filed on 5/24/13).
Regarding claim 1, Kinast teaches a patient monitoring system having defibrillation protection, the patient monitoring system comprising: a data acquisition device that records physiological signals from a patient (col. 3 and lines 19-21-use the existing ECG electrodes, as well as the associated ECG cables and leadwires, for respiration monitoring; col. 3 and line 62-monitoring instrument), wherein the physiological signals recorded include respiration potentials and cardiac potentials (col. 3 and lines 19-21-use the existing ECG electrodes, as well as the associated ECG cables and leadwires, for respiration monitoring), the data acquisition device having at least two receiving ports (col. 4 and lines 46-47-voltage generator 11 delivers a total voltage, labeled V, across wires W1 and W2; Fig. 1A), each receiving port configured to connect to a patient connector (col. 3 and lines 61-65-the trunk portion of the cable spans from the monitoring instrument to the immediate proximity of the patient. At this point, in a fixture often referred to as the yoke, the trunk cable splits into the individual leadwires, which in turn connect to the individual electrodes; Fig. 1A); a leadset (col. 6 and lines 36-38-the respiration and ECG circuits might be interconnected, allowing the same cable and electrodes to be shared for both purposes) comprising: at least a first capacitive patient connector and a second capacitive patient connector (col. 3 and lines 64-65-cable splits into the individual leadwires, which in turn connect to the individual electrodes; col. 4 and lines 7-8-the leadwires may add additional shunt capacitance), wherein each capacitive patient connector is configured to capacitively couple a respective receiving port of the data acquisition device and the patient (col. 3 and lines 61-65-the trunk portion of the cable spans from the monitoring instrument to the immediate proximity of the patient. At this point, in a fixture often referred to as the yoke, the trunk cable splits into the individual leadwires, which in turn connect to the individual electrodes; col. 4 and lines 43-45-the wires W1 and W2 represent a portion of an ECG cable, each possessing a capacitance); and wherein the data acquisition device is configured to record the respiration potentials and the cardiac potentials from the patient based exclusively on signals recorded from the leadset (col. 6 and lines 36-38-the respiration and ECG circuits might be interconnected, allowing the same cable and electrodes to be shared for both purposes), including between the first capacitive patient connector and the second capacitive patient connector (col. 6 and lines 36-38-the respiration and ECG circuits might be interconnected, allowing the same cable and electrodes to be shared for both purposes; col. 4 and lines 44-45-a portion of an ECG cable, each possessing a capacitance). However, Kinast does not teach a galvanic patient connector configured to galvanically connect a first receiving port of the data acquisition device and the patient and a third receiving port.
Fuwamoto relates to an in-vehicle electrocardiograph device and a vehicle that obtain an electrocardiographic waveform of a vehicle occupant (¶3). Fuwamoto further teaches the invention using the following steps:
a galvanic patient connector configured to galvanically connect a first receiving port of the data acquisition device and the patient (¶12-the direct electrode contacts a skin of the occupant; ¶29-the direct electrode 10 is connected to a ground terminal 60; Fig. 1) and a third receiving port (¶33-the recording control device 30 together with the direct electrode 10; Fig. 1).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Kinast to include a galvanic patient connector configured to galvanically connect a first receiving port of the data acquisition device and the patient and a third receiving port of Fuwamoto in order to obtain an electrocardiographic waveform with less interruption and more accurately detect the difference in electric potential between the electrodes (Fuwamoto, ¶42; ¶55).
Regarding claim 2, the combination of Kinast and Fuwamoto teaches the patient monitoring system of claim 1, wherein the galvanic patient connector is configured to act as a reference electrode (Fuwamoto, ¶43-the electric potential of the direct electrode 10 is used as one of the reference electric potentials; ¶54-55).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Kinast to include wherein the galvanic patient connector is configured to act as a reference electrode of Fuwamoto in order to more accurately detect the difference in electric potential between the electrodes (Fuwamoto, ¶42; ¶55).
Regarding claim 3, the combination of Kinast and Fuwamoto teaches the patient monitoring system of claim 1, further comprising at least a third capacitive patient connector (Fuwamoto, ¶31-the number of the electrodes included in the capacitive-coupled electrode 20 is not limited to two. The capacitive-coupled electrode 20 may include…three or more electrodes that are electrically connected to each other).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Kinast to include at least a third capacitive patient connector of Fuwamoto in order to obtain a more accurate electrocardiographic waveform (Fuwamoto, ¶43).
A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. The combination of Kinast and Fuwamoto reads on the claims as the capacitive and galvanic electrodes could be moved to any location.
Regarding claim 4, the combination of Kinast and Fuwamoto teaches the patient monitoring system of claim 1, wherein the first capacitive patient connector and the second capacitive patient connector are drive electrodes configured to inject an AC current into the patient (Kinast, col. 3 and lines 64-65-cable splits into the individual leadwires, which in turn connect to the individual electrodes; col. 4 and lines 7-8-the leadwires may add additional shunt capacitance; col. 5 and lines 53-57- measuring circuit 45 is an impedance measurement circuit and comprises current source 20, which delivers AC current, I, and voltage measurement device 21, which measures the AC voltage developed across network 40), and the galvanic patient connector is configured to act as a ground (Fuwamoto, ¶29-the direct electrode 10 is connected to a ground terminal 60).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Kinast to include the galvanic patient connector is configured to act as a ground of Fuwamoto in order to more accurately detect the difference in electric potential between the electrodes (Fuwamoto, ¶42; ¶55).
Regarding claim 5, the combination of Kinast and Fuwamoto teaches the patient monitoring system of claim 1, wherein the first capacitive patient connector includes a first capacitive electrode and a first leadwire configured to connect the first capacitive electrode to the respective receiving port (Kinast, col. 3 and lines 64-65-cable splits into the individual leadwires, which in turn connect to the individual electrodes; col. 4 and lines 7-8-the leadwires may add additional shunt capacitance; col. 4 and lines 46-47-voltage generator 11 delivers a total voltage, labeled V, across wires W1 and W2; Fig. 1A); and wherein the second capacitive patient connector includes a second capacitive electrode and a second leadwire configured to connect the second capacitive electrode to the respective receiving port (Kinast, col. 3 and lines 64-65-cable splits into the individual leadwires, which in turn connect to the individual electrodes; col. 4 and lines 7-8-the leadwires may add additional shunt capacitance; col. 4 and lines 7-8-the leadwires may add additional shunt capacitance; col. 4 and lines 46-47-voltage generator 11 delivers a total voltage, labeled V, across wires W1 and W2; Fig. 1A).
Regarding claim 11, Kinast teaches a respiration monitoring system having defibrillation protection, the respiration monitoring system comprising: a data acquisition device configured to record cardiac potentials and respiration potentials from a patient (col. 3 and lines 19-21-use the existing ECG electrodes, as well as the associated ECG cables and leadwires, for respiration monitoring; col. 3 and line 62-monitoring instrument), the data acquisition device having at least two receiving ports (col. 4 and lines 46-47-voltage generator 11 delivers a total voltage, labeled V, across wires W1 and W2; Fig. 1A), each receiving port configured to connect to a patient connector (col. 3 and lines 61-65-the trunk portion of the cable spans from the monitoring instrument to the immediate proximity of the patient. At this point, in a fixture often referred to as the yoke, the trunk cable splits into the individual leadwires, which in turn connect to the individual electrodes; Fig. 1A); a leadset (col. 6 and lines 36-38-the respiration and ECG circuits might be interconnected, allowing the same cable and electrodes to be shared for both purposes) comprising a set of capacitive patient connectors (col. 3 and lines 64-65-cable splits into the individual leadwires, which in turn connect to the individual electrodes; col. 4 and lines 7-8-the leadwires may add additional shunt capacitance); the set of capacitive patient connectors comprising at least a first capacitive patient connector and a second capacitive patient connector (col. 3 and lines 64-65-cable splits into the individual leadwires, which in turn connect to the individual electrodes; col. 4 and lines 7-8-the leadwires may add additional shunt capacitance), wherein each capacitive patient connector is configured to capacitively couple a respective receiving port of the data acquisition device and the patient (col. 3 and lines 61-65-the trunk portion of the cable spans from the monitoring instrument to the immediate proximity of the patient. At this point, in a fixture often referred to as the yoke, the trunk cable splits into the individual leadwires, which in turn connect to the individual electrodes; col. 4 and lines 43-45-the wires W1 and W2 represent a portion of an ECG cable, each possessing a capacitance); wherein the first capacitive patient connector and the second capacitive patient connector are configured to transmit the cardiac potentials and the respiration potentials from the patient (col. 10 and lines 50-52-demodulator 34 receives the differential voltage developed across network 39 by the injected charge, through coupling capacitors Cv; col. 6 and lines 36-38-the respiration and ECG circuits might be interconnected, allowing the same cable and electrodes to be shared for both purposes); and wherein the data acquisition device is configured to record the cardiac potentials and the respiration potentials from the patient based exclusively on the signals recorded from the leadset (col. 6 and lines 36-38-the respiration and ECG circuits might be interconnected, allowing the same cable and electrodes to be shared for both purposes), including between the first capacitive patient connector and the second capacitive patient connector (col. 6 and lines 36-38-the respiration and ECG circuits might be interconnected, allowing the same cable and electrodes to be shared for both purposes; col. 4 and lines 44-45-a portion of an ECG cable, each possessing a capacitance). However, Kinast does not teach a third receiving port, a galvanic patient connector, the galvanic patient connector configured to galvanically connect a first receiving port of the data acquisition device and the patient; wherein the galvanic patient connector is configured to act as a reference.
Fuwamoto teaches a third receiving port (¶33-the recording control device 30 together with the direct electrode 10; Fig. 1), a galvanic patient connector (¶29-direct electrode 10), the galvanic patient connector configured to galvanically connect a first receiving port of the data acquisition device and the patient (¶12-the direct electrode contacts a skin of the occupant; ¶29-the direct electrode 10 is connected to a ground terminal 60; Fig. 1); wherein the galvanic patient connector is configured to act as a reference (¶43-the electric potential of the direct electrode 10 is used as one of the reference electric potentials; ¶54-55).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Kinast to include a third receiving port, a galvanic patient connector, the galvanic patient connector configured to galvanically connect a first receiving port of the data acquisition device and the patient; wherein the galvanic patient connector is configured to act as a reference of Fuwamoto in order to obtain an electrocardiographic waveform with less interruption and more accurately detect the difference in electric potential between the electrodes (Fuwamoto, ¶42; ¶55).
Regarding claim 12, the combination of Kinast and Fuwamoto teaches the respiration monitoring system of claim 11, further comprising at least a third capacitive patient connector (Fuwamoto, ¶31-the number of the electrodes included in the capacitive-coupled electrode 20 is not limited to two. The capacitive-coupled electrode 20 may include…three or more electrodes that are electrically connected to each other).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Kinast to include at least a third capacitive patient connector of Fuwamoto in order to obtain a more accurate electrocardiographic waveform (Fuwamoto, ¶43).
A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. The combination of Kinast and Fuwamoto reads on the claims as the capacitive and galvanic electrodes could be moved to any location.
Regarding claim 14, the combination of Kinast and Fuwamoto teaches the respiration monitoring system of claim 11, wherein the first capacitive patient connector includes a first capacitive electrode and a first leadwire connecting the first capacitive electrode to the respective receiving port (Kinast, col. 3 and lines 64-65-cable splits into the individual leadwires, which in turn connect to the individual electrodes; col. 4 and lines 7-8-the leadwires may add additional shunt capacitance; col. 4 and lines 46-47-voltage generator 11 delivers a total voltage, labeled V, across wires W1 and W2; Fig. 1A); and wherein the second capacitive patient connector includes a second capacitive electrode and a second leadwire connecting the second capacitive electrode to the respective receiving port (Kinast, col. 3 and lines 64-65-cable splits into the individual leadwires, which in turn connect to the individual electrodes; col. 4 and lines 7-8-the leadwires may add additional shunt capacitance; col. 4 and lines 7-8-the leadwires may add additional shunt capacitance; col. 4 and lines 46-47-voltage generator 11 delivers a total voltage, labeled V, across wires W1 and W2; Fig. 1A).
Claims 6 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Kinast in view of Fuwamoto as applied to claims 1-5, 11-12, and 14 above, and further in view of Zdeblick (US 20100204766 filed on 12/22/06).
Regarding claim 6, the combination of Kinast and Fuwamoto teaches the patient monitoring system of claim 1. However, the combination of Kinast and Fuwamoto does not teach wherein the first capacitive patient connector and the second capacitive patient connector each include a capacitive leadwire configured to connect to a galvanic electrode, the capacitive leadwire comprising: an electrode end configured to connect to the galvanic electrode; a first conductive layer extending from the electrode end; a device end connectable to the data acquisition device; a second conductive layer extending from the device end; and wherein the first conductive layer is galvanically isolated from the second conductive layer such that the first conductive layer and the second conductive layer form a capacitor.
Zdeblick teaches wherein the first capacitive patient connector and the second capacitive patient connector each include a capacitive leadwire configured to connect to a galvanic electrode, the capacitive leadwire comprising: an electrode end configured to connect to the galvanic electrode (¶269-each lead L1-LN then includes a ground line S1; ¶118-desired electrodes can couple to S1); a first conductive layer extending from the electrode end (¶245-a capacitor with a first conductive layer 2001); a device end connectable to the data acquisition device (¶509-the central control unit may be electrically coupled to the lead by a connector, such as a proximal end IS-1 connection); a second conductive layer extending from the device end (¶245-a second conductive layer 2003); and wherein the first conductive layer is galvanically isolated from the second conductive layer such that the first conductive layer and the second conductive layer form a capacitor (¶245-a capacitor with a first conductive layer 2001, a dielectric layer 2002, and a second conductive layer 2003).
Zdeblick relates to enabling robust, reliable control functionality for effectors present on intraluminal structures, e.g., vascular leads, as well as other types of implantable devices (¶81).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Kinast to include wherein the first capacitive patient connector and the second capacitive patient connector each include a capacitive leadwire configured to connect to a galvanic electrode, the capacitive leadwire comprising: an electrode end configured to connect to the galvanic electrode; a first conductive layer extending from the electrode end; a device end connectable to the data acquisition device; a second conductive layer extending from the device end; and wherein the first conductive layer is galvanically isolated from the second conductive layer such that the first conductive layer and the second conductive layer form a capacitor of Zdeblick in order to act as a blocking capacitor that prevents charge build-up in the electrode (Zdeblick, ¶229).
Regarding claim 15, the combination of Kinast and Fuwamoto teaches the respiration monitoring system of claim 14. However, the combination of Kinast and Fuwamoto does not teach wherein the first capacitive patient connector and the second capacitive patient connector each include a capacitive leadwire configured to connect to a galvanic electrode, the capacitive leadwire comprising: an electrode end configured to connect to the galvanic electrode; a first conductive layer extending from the electrode end; a device end connectable to the data acquisition device; a second conductive layer extending from the device end toward the electrode end; and wherein the first conductive layer is galvanically isolated from the second conductive layer such that the first conductive layer and the second conductive layer form a capacitor.
Zdeblick teaches wherein the first capacitive patient connector and the second capacitive patient connector each include a capacitive leadwire configured to connect to a galvanic electrode, the capacitive leadwire comprising: an electrode end configured to connect to the galvanic electrode (¶269-each lead L1-LN then includes a ground line S1; ¶118-desired electrodes can couple to S1); a first conductive layer extending from the electrode end (¶245-a capacitor with a first conductive layer 2001); a device end connectable to the data acquisition device (¶509-the central control unit may be electrically coupled to the lead by a connector, such as a proximal end IS-1 connection); a second conductive layer extending from the device end toward the electrode end (¶245-a second conductive layer 2003); and wherein the first conductive layer is galvanically isolated from the second conductive layer such that the first conductive layer and the second conductive layer form a capacitor (¶245-a capacitor with a first conductive layer 2001, a dielectric layer 2002, and a second conductive layer 2003).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Kinast to include wherein the first capacitive patient connector and the second capacitive patient connector each include a capacitive leadwire configured to connect to a galvanic electrode, the capacitive leadwire comprising: an electrode end configured to connect to the galvanic electrode; a first conductive layer extending from the electrode end; a device end connectable to the data acquisition device; a second conductive layer extending from the device end toward the electrode end; and wherein the first conductive layer is galvanically isolated from the second conductive layer such that the first conductive layer and the second conductive layer form a capacitor of Zdeblick in order to act as a blocking capacitor that prevents charge build-up in the electrode (Zdeblick, ¶229).
Claims 7-9 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Kinast in view of Fuwamoto and further in view of Zdeblick as applied to claims 1-6, 11-12, and 14-15 above, and further in view of LONGINOTTI-BUITONI (WO 2016009277 filed on 7/14/15), hereinafter referred to as Long.
Regarding claim 7, the combination of Kinast, Fuwamoto, and Zdeblick teaches the patient monitoring system of claim 6. However, the combination of Kinast, Fuwamoto, and Zdeblick does not teach wherein the first conductive layer and the second conductive layer are parallel wires divided by a substrate.
Long teaches wherein the first conductive layer and the second conductive layer (Long, ¶59-conductive trace may include a conductive ink layer on the inner and outer surfaces of the garment) are parallel wires divided by a substrate (Long, ¶67-parallel conductive ink traces; ¶77-substrate).
Long relates generally to wearable electronics formed of compression garments onto which stretchable and conductive ink is patterned. In particular, described herein are structures having enhanced conductivity and stretchability in which the conductive ink forms a partially-mixed gradient with an insulative and adhesive base that can be applied directly or transferred onto a compression fabric, and used to form wearable electronics (¶3). Long additionally relates to an electrocardiogram (ECG) sensor and a respiratory sensor (¶55).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective
filing date of the claimed invention to modify the invention of Kinast to include wherein the first conductive layer and the second conductive layer are parallel wires divided by a substrate of Long in order to continuously monitor a wearer’s electrocardiogram (ECG) and respiration (Long, ¶55; ¶67; ¶79).
Regarding claim 8, the combination of Kinast, Fuwamoto, Zdeblick and Long teaches the patient monitoring system of claim 7, wherein the first conductive layer and the second conductive layer (Long, ¶59-conductive trace may include a conductive ink layer on the inner and outer surfaces of the garment) are comprised of a conductive ink printed on a substrate (Long, ¶77-conductive material on a substrate, conductive ink).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective
filing date of the claimed invention to modify the invention of Kinast to include wherein the first conductive layer and the second conductive layer are comprised of a conductive ink printed on a substrate of Long in order to continuously monitor a wearer’s electrocardiogram (ECG) and respiration (Long, ¶55; ¶67; ¶79).
Regarding claim 9, the combination of Kinast, Fuwamoto, Zdeblick, and Long teaches the patient monitoring system of claim 8, wherein the galvanic patient connector (Long, ¶439-2 electrodes…legs; ¶472-when used as a connector; ¶138-leg leads; ¶71-reference line may be a “ground.sup”; ¶344-ground signal) includes a conductive leadwire configured to connect to a galvanic electrode (Long, ¶71-reference line may be a “ground.sup”; ¶344-ground signal; ¶472-when used as a connector; ¶80-leads), wherein the conductive leadwire is comprised of a conductive ink printed on a substrate (Long, ¶77-conductive material on a substrate, conductive ink), and further comprising a resistor of at least 1 kilo-ohm printed on the conductive leadwire (Long, ¶88-resistivity of the conductive trace may be less than about 10 Kohms/square; ¶398).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective
filing date of the claimed invention to modify the invention of Kinast to include wherein the galvanic patient connector includes a conductive leadwire configured to connect to a galvanic electrode, wherein the conductive leadwire is comprised of a conductive ink printed on a substrate, and further comprising a resistor of at least 1 kilo-ohm printed on the conductive leadwire of Long in order to continuously monitor a wearer’s electrocardiogram (ECG) and respiration (Long, ¶55; ¶67; ¶79).
Regarding claim 16, the combination of Kinast, Fuwamoto, and Zdeblick teaches the respiration monitoring system of claim 15. However, the combination of Kinast, Fuwamoto, and Zdeblick does not teach wherein the first conductive layer and the second conductive layer are parallel wires divided by a substrate.
Long teaches wherein the first conductive layer and the second conductive layer (Long, ¶59-conductive trace may include a conductive ink layer on the inner and outer surfaces of the garment) are parallel wires divided by a substrate (Long, ¶67-parallel conductive ink traces; ¶77-substrate).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective
filing date of the claimed invention to modify the invention of Kinast to include wherein the first conductive layer and the second conductive layer are parallel wires divided by a substrate of Long in order to continuously monitor a wearer’s electrocardiogram (ECG) and respiration (Long, ¶55; ¶67; ¶79).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Kinast in view of Fuwamoto as applied to claims 1-5, 11-12, and 14 above, and further in view of Asselin (WO 2016044933 filed on 9/23/15).
Regarding claim 10, the combination of Kinast and Fuwamoto teaches the patient monitoring system of claim 1, and wherein the leadset includes the galvanic patient connector (Fuwamoto, ¶29-the direct electrode 10 contacts the driver's skin, the direct electrode 10 is connected to a ground terminal 60; Fig. 1). The combination of Kinast and Fuwamoto does not teach wherein the data acquisition device is a 12 lead electrocardiograph configured to record the cardiac potentials from the patient, the 12 lead electrocardiograph having 10 receiving ports; and nine capacitive patient connectors.
Asselin teaches wherein the data acquisition device is a 12 lead electrocardiograph configured to record the cardiac potentials from the patient, the 12 lead electrocardiograph having 10 receiving ports (Asselin, ¶92; Fig. 11); and nine capacitive patient connectors (Asselin, ¶65-sensors 10 arranged in a matrix configuration such that no matter how the patient is placed on the matrix 202, there would always be at least one sensor at a location on the patient's body that corresponds to the physical placement of a conventional ECG electrode; ¶43-senor array captures ECG signals without direct contact with the patient's skin; Fig. 5).
Asselin generally relates to electro-cardiogram systems (¶2). Asselin additionally relates to
circumventing issues associated with contact electrodes by being contactless and by allowing multi-
hour, multiple lead monitoring on a daily basis and for life (¶13).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective
filing date of the claimed invention to modify the invention of Kinast to include wherein the data acquisition device is a 12 lead electrocardiograph configured to record the cardiac potentials from the patient, the 12 lead electrocardiograph having 10 receiving ports; and nine capacitive patient connectors of Asselin in order for frequent, inexpensive and accessible recording of ECG data from any patient or person easily, unobtrusively and quickly by eliminating the need to manually identify and prepare areas on the patient's body for contact sensors and to place sensors on those areas (Asselin, ¶13).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Kinast in view of Fuwamoto as applied to claim 1-5, 11-12, and 14 above, and further in view of Chiu Brun del Re (US 20040073104 filed on 8/21/03), hereinafter referred to as Brun.
Regarding claim 13, the combination of Kinast and Fuwamoto teaches the respiration monitoring system of claim 12. However, the combination of Kinast and Fuwamoto does not teach wherein the data acquisition device is configured to utilize the galvanic patient connector to remove noise caused by a change in a DC offset in the cardiac potentials recorded between each of the first capacitive patient connector, the second capacitive patient connector, and the third capacitive patient connector.
Brun teaches wherein the data acquisition device is configured to utilize the galvanic patient
connector to remove noise caused by a change in a DC offset in the cardiac potentials recorded between
each of the first capacitive patient connector, the second capacitive patient connector, and the third
capacitive patient connector (¶72-serves to discharge the input of DC offsets; ¶139-artifacts
disappeared; ¶129-ECG inputs grounded to the subject body-reference; ¶75-capacitive electrodes, ECG;
¶113).
Brun relates generally to electrodes for bio-electric field sensing. In particular, it relates to
electrodes for electro-cardiograms (ECG), electro encephalograms (BEG), heart rate monitoring systems and the like (¶1). Brun additionally relates to long term monitoring of patient heart rate and ECGs
without the use of uncomfortable adhesives found in typical existing ohmic electrodes (¶113).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective
filing date of the claimed invention to modify the invention of Kinast to include wherein the data
acquisition device is configured to utilize the galvanic patient connector to remove noise caused by a
change in a DC offset in the cardiac potentials recorded between each of the first capacitive patient
connector, the second capacitive patient connector, and the third capacitive patient connector of Brun
in order for the long term monitoring of patient heart rate and ECGs without the use of uncomfortable
adhesives found in typical existing ohmic electrodes (Brun, ¶113).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Barua (US 11444646 filed on 12/31/15) in view of Fuwamoto.
Regarding claim 17, Barua teaches a leadset for recording physiological signals from a patient, the leadset comprising: and at least two capacitive patient connectors (col. 17 and line 18-two electrodes or sensor lead cables), wherein each capacitive patient connector includes a capacitive leadwire configured to connect to a galvanic electrode (col. 5 and lines 23-25-the first capacitor and second capacitor coupled in series being connected between the first resistor and the ground terminal; col. 19 and lines 2-3-grounding electrode 450), wherein the capacitive leadwire comprises a capacitor configured to capacitively transmit the physiological signals (col. 17 and lines 30-32-for each lead, comprise a pair of boot strapped capacitors (C1 250 for the first lead, and C2 255 for the second lead); col. 17 and lines 24-27-leads transmit the physiological signal from the electrodes or sensors (not shown) attached to the subject, and into the acquisition circuitry comprising a series of electrical components). However, Barua does not explicitly recite a galvanic patient connector comprising a conductive leadwire and a galvanic electrode.
a galvanic patient connector comprising a conductive leadwire and a galvanic electrode (¶12-the direct electrode contacts a skin of the occupant; ¶29-the direct electrode 10 is connected to a ground terminal 60; Fig. 1).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Kinast to include a galvanic patient connector comprising a conductive leadwire and a galvanic electrode of Fuwamoto in order to obtain an electrocardiographic waveform with less interruption and more accurately detect the difference in electric potential between the electrodes (Fuwamoto, ¶42; ¶55).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Barua in view of Fuwamoto as applied to claim 17 above, and further in view of Zdeblick (US 20100204766 filed on 12/22/06).
Regarding claim 18, the combination of Barua and Fuwamoto teaches the leadset of claim 17. However, the combination of Barua and Fuwamoto does not teach wherein each capacitive leadwire comprises: an electrode end connecting to the galvanic electrode; a first conductive layer extending from the electrode end; a device end connectable to a data acquisition device; a second conductive layer extending from the device end toward the electrode end; and wherein the first conductive layer is galvanically isolated from the second conductive layer such that the first conductive layer and the second conductive layer form the capacitor.
Zdeblick teaches wherein each capacitive leadwire comprises: an electrode end connecting to the galvanic electrode (¶269-each lead L1-LN then includes a ground line S1; ¶118-desired electrodes can couple to S1); a first conductive layer extending from the electrode end (¶245-a capacitor with a first conductive layer 2001); a device end connectable to a data acquisition device (¶509-the central control unit may be electrically coupled to the lead by a connector, such as a proximal end IS-1 connection); a second conductive layer extending from the device end toward the electrode end (¶245-a second conductive layer 2003); and wherein the first conductive layer is galvanically isolated from the second conductive layer such that the first conductive layer and the second conductive layer form the capacitor (¶245-a capacitor with a first conductive layer 2001, a dielectric layer 2002, and a second conductive layer 2003).
Zdeblick relates to enabling robust, reliable control functionality for effectors present on intraluminal structures, e.g., vascular leads, as well as other types of implantable devices (¶81).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Barua to include wherein each capacitive leadwire comprises: an electrode end connecting to the galvanic electrode; a first conductive layer extending from the electrode end; a device end connectable to a data acquisition device; a second conductive layer extending from the device end toward the electrode end; and wherein the first conductive layer is galvanically isolated from the second conductive layer such that the first conductive layer and the second conductive layer form the capacitor of Zdeblick in order to act as a blocking capacitor that prevents charge build-up in the electrode (Zdeblick, ¶229).
Claims 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Barua in view of Fuwamoto and further in view of Zdeblick as applied to claim 18 above, and further in view of LONGINOTTI-BUITONI (WO 2016009277 filed on 7/14/15), hereinafter referred to as Long.
Regarding claim 19, the combination of Barua, Fuwamoto, and Zdeblick teaches the leadset of claim 18. However, the combination of Barua, Fuwamoto, and Zdeblick does not teach wherein the first conductive layer and the second conductive layer are parallel wires divided by a substrate.
Long teaches wherein the first conductive layer and the second conductive layer (Long, ¶59-conductive trace may include a conductive ink layer on the inner and outer surfaces of the garment) are parallel wires divided by a substrate (Long, ¶67-parallel conductive ink traces; ¶77-substrate).
Long relates generally to wearable electronics formed of compression garments onto which stretchable and conductive ink is patterned. In particular, described herein are structures having enhanced conductivity and stretchability in which the conductive ink forms a partially-mixed gradient with an insulative and adhesive base that can be applied directly or transferred onto a compression fabric, and used to form wearable electronics (¶3). Long additionally relates to an electrocardiogram (ECG) sensor and a respiratory sensor (¶55).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective
filing date of the claimed invention to modify the invention of Barua to include wherein the first conductive layer and the second conductive layer are parallel wires divided by a substrate of Long in order to continuously monitor a wearer’s electrocardiogram (ECG) and respiration (Long, ¶55; ¶67; ¶79).
Regarding claim 20, the combination of Barua, Fuwamoto, and Zdeblick teaches the leadset of claim 18. However, the combination of Barua, Fuwamoto, and Zdeblick does not teach wherein the first conductive layer and the second conductive layer are comprised of a conductive ink printed on a substrate.
Long teaches wherein the first conductive layer and the second conductive layer (Long, ¶59-conductive trace may include a conductive ink layer on the inner and outer surfaces of the garment) are comprised of a conductive ink printed on a substrate (Long, ¶77-conductive material on a substrate, conductive ink).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective
filing date of the claimed invention to modify the invention of Barua to include wherein the first conductive layer and the second conductive layer are comprised of a conductive ink printed on a substrate of Long in order to continuously monitor a wearer’s electrocardiogram (ECG) and respiration (Long, ¶55; ¶67; ¶79).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Barua in view of Fuwamoto as applied to claim 17 above, and further in view of Kinast.
Regarding claim 21, the combination of Barua and Fuwamoto teaches the leadset of claim 17. While Fuwamoto teaches an electric potential of the capacitive-coupled electrode 20 , which fluctuates in accordance with fluctuations in the electric potential of the driver's body, is transmitted to the recording control device 30 (¶31) and the voltage follower 32 transmits the voltage signal from the capacitive-coupled electrode 20 to the output terminal 32 C (¶35), the combination of Barua and Fuwamoto does not teach wherein each capacitive patient connector is configured to transmit the physiological signals from the patient, including respiration potentials and cardiac potentials.
Kinast teaches wherein each capacitive patient connector is configured to transmit the physiological signals from the patient, including respiration potentials and cardiac potentials (col. 10 and lines 50-52-demodulator 34 receives the differential voltage developed across network 39 by the injected charge, through coupling capacitors Cv; col. 6 and lines 36-38-the respiration and ECG circuits might be interconnected, allowing the same cable and electrodes to be shared for both purposes)
Therefore, it would have been obvious to one of ordinary skill in the art before the effective
filing date of the claimed invention to modify the invention of Barua to include wherein each capacitive patient connector is configured to transmit the physiological signals from the patient, including respiration potentials and cardiac potentials of Kinast in order to allow the same cable and electrodes to be shared for both purposes (Kinast, col. 6 and lines 36-38).
Conclusion
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/L.N.H./Examiner, Art Unit 3792
/UNSU JUNG/Supervisory Patent Examiner, Art Unit 3792