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 .
Election/Restrictions
Applicant’s election without traverse of Group 1 in the reply filed on 11/17/2025 is acknowledged.
Claim(s) 18-24 is/are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/17/2025.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim(s) 2, 5-7 & 9 is/are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding Claim 2
Claim 2 recites, “wherein the electrode vest does not include any electrical leads or traces for conducting the electrophysiological signals from the electrodes”. The Specification as originally filed states in Para 0009:
The exposed connector portions are accessible from the exterior side of the vest (when worn), such that each electrode can be individually connected to an external electrical lead for transmitting the signal to the ECGi measurement apparatus. This means the vest does not include any integrated or embedded metal electrical leads or traces connected to the electrodes for conducting the electrophysiological signals to another location, e.g. to one or more connectors, which in turn makes the vest entirely washable and thereby re-useable. That is, the electrical leads can be disconnected after use for washing. It also means that the vest is compatible with cardiovascular magnetic resonance (CMR) imaging, because the electrical leads can be disconnected from each electrode prior to performing CMR imaging.
The claim limitation of “wherein the electrode vest does not include any electrical leads or traces for conducting the electrophysiological signals from the electrodes” is interpreted as vest as having no leads or traces. However, this is not physically possible. There needs to be a means for the signals to measured by the ECGi measurement apparatus. Based on Para 0009, it appears that the Applicant is intending to claim no integrated or embedded leads or traces within the vest. Because the ECGi vest would not be able to function as claimed with out leads or traces unless the ECGi electrodes were wireless. There is no disclosure within the Disclosure as originally filed that the ECGi electrodes are wireless. It is unclear how to interpret the claim limitation. For the purpose of examination, the Examiner is providing both an 1) non-integrated wire interpretation and 2) wireless interpretation.
Regarding Claim 5-7
Claim 5-7 are directed to the specific parts of the electrode. However, there appears to be overlap in elements. For example, “sensing portion” seems to be the same as the “third part”. A similar analysis could be applied to “exposed connector portion”, “electrode body”, “first part”, “second part”, “first flange”, “second flange”, etc. The specific overlaps of one claimed element to another are not exactly clear to the Examiner. It seems that the claimed elements from Claim 5 should be elements of the sensing portion and connector portion of the electrode from Claim 1. Furthermore, it is not clear the relationship between the electrode elements of Claim 1 and the electrode elements of Claims 5-7. For the purpose of examination, the Examiner is interpreting the claimed elements as described below within the rejection.
Regarding Claim 6
Claim 6 states, “optionally or preferably”. This claim limitation is confusing as it is not understood if the claim limitation is being claimed or not. The Examiner is interpreting the claim limitation as not being required.
Regarding Claim 9
Claim 9 recites, “substantially”. The term “substantially” in Claim 9 is a relative term which renders the claim indefinite. The term “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1 & 3-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Robinson et al. (U.S. Patent Application 2018/0318606 A1) and further in view of O’Keefe et al. (U.S. Patent Application 2016/0331321 A1).
Claim 1: Robinson teaches –
An electrocardiographic imaging (ECGi) [Electrocardiographic Imaging (ECGI)] (Para 0038) electrode vest [wearing a vest of electrodes] (Para 0038) and an ECGi measurement apparatus [electrical potential measuring device] (Para 0045) [noninvasive systems…comprising a noninvasive means…wherein the noninvasive imaging means comprises an electrical potential measuring device and a geometry determining device] (Para 0045).
Robinson fails to teach the specifics regarding the electrode vest. However, O’keefe teaches –
An electrode vest [precordial overlay vest] (Figure 5, Element 200) comprising:
Examiner’s Note: Precordial means1 – situated or occurring in front of the heart. In other words, the prior art vest covers a patient’s cheat area.
a flexible [a wearable material, for example, an elastic material, foam, mesh, polymer, composite, or the like] (Para 0033) base layer [A conductive band circumscribes the elongated slot] (Para 0005 and Figure 1, Element 122A-122F & Figure 5, Element 210) configured to cover at least a patient's chest area [precordial overlay vest] (Figure 5, Element 200); and
Examiner’s Note: O’Keefe discloses in Para 0034:
It should be understood that any of the embodiments and components of the electrode placement device 100 described above may be incorporated into the electrode placement device 200 having the precordial overlay vest 210 depicted in FIG. 5
It is not an improper combination of embodiments to refer to Figures 1-5 for what it teaches regarding the respectively named elements. In other words, referencing Element 130A-130F is understood to be the same as and/or similar to Element 230A-230F.
a plurality of dry contact [direct contact] (Para 0020) electrodes [electrodes] (Figure 5, Element 230A-230F) attached to the flexible base layer [electrodes 230A-230F may be adjustably positioned within the elongated slots] (Para 0034) [precordial overlay vest 210 may comprise a one or more elongated slots 220A-220F] (Para 0034) and
distributed over at least a chest area (as shown in Figure 5) of the flexible base layer to acquire electrophysiological signals from the patient's skin surface [monitor the electrical activity of a patient's heart. ECG devices include a plurality of electrodes that may be positioned on a patient to monitor this electrical activity] (Para 0002);
wherein each electrode [electrodes] (Figure 5, Element 230A-230F) comprises a sensing portion [annular portion] (Figure 2, Element 134) having an exposed sensing surface [direct contact] (Para 0020) on an interior skin facing side of the electrode to contact the user's skin surface [an electrode 130A-130F positioned within an individual elongated slot 120A-120F extends through the harness 110 and may, in operation, contact a patient] (Para 0016) when the vest is worn [precordial overlay vest] (Figure 5, Element 200), and
an exposed connector portion [conducting disc] [sensor stud] (Figure 2, Element 140 & 142) on an exterior side of the electrode for removably connecting [electrode placement devices include electrode receiving portions within the elongated slots to allow electrodes to be removably coupled to the elongated slots for adjustment reuse] (Para 0035) with an electrical lead [lead wires 282A-282F electrically coupled to the electrodes 230A-230F] (Para 0034) of an ECG measurement apparatus [device that transmits and/or electronically stores the ECG data measured by the electrodes] (Para 0034) in order to allow for a reusable vest with adjustable and removeable electrodes for quick and precise placement of the electrodes on to the patient (Para 0035)
Examiner’s Note: O’Keefe teaches electrodes that are removably connected to the lead wires through elongated slots. The electrodes of O’Keefe are secured to the vest with Element 134 and 132 via a snap-fit (Para 0023) with the conductive band therebetween.
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 ECGi electrode vest of Robinson to include the specific details of the electrode vest construction as taught by O’Keefe in order to allow for a reusable vest with adjustable and removeable electrodes for quick and precise placement of the electrodes on to the patient (Para 0035).
Claim 3/1: Robinson fails to teach the specifics regarding the electrode vest. However, O’Keefe teaches wherein at least part of the electrodes are formed of or comprise a conductive polymer material [The conducting disc 140 may comprise a conductive material, for example, conductive metals, conductive polymers, or the like] (Para 0018) in order to allow for a reusable vest with adjustable and removeable electrodes for quick and precise placement of the electrodes on to the patient (Para 0035).
Claim 4/1: Robinson teaches an ECGi measurement apparatus [electrical potential measuring device] (Para 0045). Robinson fails to teach the specifics regarding the electrode vest. However, O’Keefe teaches wherein the connector portion [conducting disc] [sensor stud] (Figure 2, Element 140 & 142) comprises a protrusion [sensor stud] (Figure 2, Element 142) for removably connecting [electrode placement devices include electrode receiving portions within the elongated slots to allow electrodes to be removably coupled to the elongated slots for adjustment reuse] (Para 0035) with an electrical lead [lead wires 282A-282F electrically coupled to the electrodes 230A-230F] (Para 0034) of an ECG measurement apparatus [device that transmits and/or electronically stores the ECG data measured by the electrodes] (Para 0034) in order to allow for a reusable vest with adjustable and removeable electrodes for quick and precise placement of the electrodes on to the patient (Para 0035).
Claim 5/1: Robinson fails to teach the specifics regarding the electrode vest. However, O’Keefe teaches –
wherein the base layer [a wearable material, for example, an elastic material, foam, mesh, polymer, composite, or the like] (Para 0033) comprises a plurality of openings [elongated slots] (Figure 5, Element 220A-220F) [A conductive band circumscribes the elongated slot] (Para 0005 and Figure 1, Element 122A-122F & Figure 5, Element 210), and
wherein each electrode [electrodes] (Figure 5, Element 230A-230F) extends through (as shown in Figures 2 & 5) a respective one of the plurality of openings [elongated slots] (Figure 5, Element 220A-220F) and comprises
first [electrode foam] (Figure 2, Element 138) and second flanges [conducting disc] (Figure 2, Element 140) that extend over opposite sides of the base layer [A conductive band circumscribes the elongated slot] (Para 0005 and Figure 1, Element 122A-122F & Figure 5, Element 210) to grip the base layer therebetween [a portion of the harness 110, e.g., the conductive band 122A-122F, is disposed between the electrode foam 138 and the conducting disc 140 of each electrode 130A-130F] (Para 0021) in order to allow for a reusable vest with adjustable and removeable electrodes for quick and precise placement of the electrodes on to the patient (Para 0035).
Examiner’s Note: Element 138 and Element 140 are disc-shaped that use a snap-fit to couple to the vest through the elongated slots. The disc shaped property of the elements acts as a flange to allow the electrode to be positioned on the vest.
Claim 6/5/1: Robinson fails to teach the specifics regarding the electrode vest. However, O’Keefe teaches –
wherein each electrode [electrodes] (Figure 5, Element 230A-230F) comprises
an electrode body [electrodes] (Figure 2, Element 130) with a first part (Figure 2, Element 138 & 132) and a second part (Figure 2, Element 140 & 142),
the first part including the first flange [electrode foam] (Figure 2, Element 138) and
the second part including the second flange [conducting disc] (Figure 2, Element 140),
the first and second parts being connectable to each other through a respective opening [elongated slots] (Figure 5, Element 220A-220F) in the base layer [a wearable material, for example, an elastic material, foam, mesh, polymer, composite, or the like] (Para 0033) to attach the electrode body to the base layer [The electrode 130 may further comprises electrode foam 138 and a conducting disc 140, each comprising a hole… When assembled, the extending portion 136 of the eyelet 132 may extend through the holes of both the electrode foam 138 and the conducting disc 140] (Para 0018),
optionally or preferably, wherein the first and second parts are connectable in a snap-fit manner [sensor stud 142 or other electrode component(s) may provide a snap fit location] (Para 0023) in order to allow for a reusable vest with adjustable and removeable electrodes for quick and precise placement of the electrodes on to the patient (Para 0035).
Claim 7/6/5/1: Robinson fails to teach the specifics regarding the electrode vest. However, O’Keefe teaches –
wherein each electrode comprises a third part [annular portion] (Figure 2, Element 134) disposed on or embedded in a skin facing side [an electrode 130A-130F positioned within an individual elongated slot 120A-120F extends through the harness 110 and may, in operation, contact a patient] (Para 0016) of the base layer [A conductive band circumscribes the elongated slot] (Para 0005 and Figure 1, Element 122A-122F & Figure 5, Element 210) adjacent the respective opening [elongated slots] (Figure 5, Element 220A-220F) and having an exposed sensing surface to contact the user's skin surface [an electrode 130A-130F positioned within an individual elongated slot 120A-120F extends through the harness 110 and may, in operation, contact a patient] (Para 0016) when the vest is worn [Patients wore a vest of 256 electrodes] (Para 0095),
the third part electrically contacting [sensor stud 142 may be electrically coupled to the extending portion 136 of the eyelet] (Para 0019) the electrode body [electrodes] (Figure 2, Element 130) when the first and second parts are connected through the respective opening [elongated slots] (Figure 5, Element 220A-220F) to extend the sensing surface [electrode foam] (Figure 2, Element 138) of the electrode [The electrode 130 may further comprises electrode foam 138 and a conducting disc 140, each comprising a hole… When assembled, the extending portion 136 of the eyelet 132 may extend through the holes of both the electrode foam 138 and the conducting disc 140] (Para 0018) in order to allow for a reusable vest with adjustable and removeable electrodes for quick and precise placement of the electrodes on to the patient (Para 0035).
Claim 8/1: Robinson fails to teach the specifics regarding the electrode vest. However, O’Keefe teaches wherein the electrodes are capable of being uniformly distributed in an array over at least the chest area of the base layer [The elongated slots 120A-120F may be uniform or variable in length with respect to one another…Additionally, the elongated slots 120A-120F may have a uniform height] (Para 0017)
Examiner’s Note: The user of the device places the electrodes in desirable locations and the slots within O’Keefe are uniform. Thus the user is capable of placing the electrodes in a uniform manner.
Claim 9/1: Robinson teaches further comprising a plurality of fiducial markers substantially co-located with the plurality of electrodes [Patients wore a vest of 256 electrodes (BioSemi, Netherlands) with small radiopaque markers attached at the location of the electrodes to visualize on cardiac imaging] (Para 0095).
Claim(s) 2, 14 & 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Robinson et al. (U.S. Patent Application 2018/0318606 A1) and O’Keefe et al. (U.S. Patent Application 2016/0331321 A1) and further in view of Price (U.S. Patent 6,141,575 A).
Claim 2/1: Robinson fails to teach the specifics with regarding to the electrode vest. O’Keefe teaches integrated electrical leads or traces [lead wires] (Figure 5, Element 282A-282F) in to the electrode vest [precordial overlay vest] (Figure 5, Element 210).
However, Price teaches wherein the electrode [electrode] (Figure 4, Element V4) does not include any integrated (See 35 USC § 112 rejection above) electrical leads or traces [lead or wire] (Col. 4, Line 50) for conducting the electrophysiological signals [electrodes which lead to the electrocardiograph] (Col. 1, Line 14-15) from the electrodes (Figure 4, Element V4) in order to have ECG assemblies that are economical to produce (Col. 2, Line 5-8) as integrating wires into vests is more complex and more expensive to manufacture.
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 integrated wires of Robinson and O’Keefe to be non-integrated as taught by Price in order to have ECG assemblies that are economical to produce (Col. 2, Line 5-8).
Examiner’s Note: See 35 USC § 112 rejection above, the Examiner is interpreting the claim limitation as interpretation (1.
Claim 14/1: Robinson teaches –
An electrocardiographic imaging (ECGi) system [Electrocardiographic Imaging (ECGI)] (Para 0038), comprising:
the ECGi electrode vest of claim 1 (See rejection above of Claim 1); and
an ECGi measurement apparatus [noninvasive systems…comprising a noninvasive means…wherein the noninvasive imaging means comprises an electrical potential measuring device and a geometry determining device] (Para 0045) comprising:
a data acquisition system with a plurality of measurement channels [ECGI can utilize an electrode vest strapped to the subject's torso and connected to a multichannel mapping system measured BSP] (Para 0039); and
a plurality of electrical leads [recording leads on the body surface] (Para 0039 and Figure 1A, Element Multi-channel ECG Mapping & 250 ECGs),
Robinson and O’Keefe fail to teach the specifics regarding the electrode lead. However, Price teaches each electrical lead [Each electrode assembly comprises an electrode to receive a lead wire] (Abstract) comprising an electrode connector head [cap head] (Figure 3, Element 28) at one end thereof configured to removably connect to a respective connector portion [conductive metal post] (Figure 3, Element 25) of a respective electrode [electrode] (Figure 4, Element V4) of the electrode band [elongated band] (Figure 3, Element 11) for transmitting electrophysiological signals to a respective measurement channel of the data acquisition system (functional claim language carrying little to no patentable weight and the prior art element is capable of performing the function) in order to have ECG assemblies that are economical to produce (Col. 2, Line 5-8) as integrating wires into vests is more complex and more expensive to manufacture.
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 electrode lead of Robinson and O’Keefe to be removeable as taught by Price in order to have ECG assemblies that are economical to produce (Col. 2, Line 5-8).
Claim 15/14/1: Robinson fails to teach the specifics with regards to the electrode vest. O’Keefe teaches wherein each connector portion [sensor stud] (Figure 2, Element 142) of each electrode [electrode] (Figure 2, Element 130) comprises a protrusion (as shown in Figure 2 with respect to Element 142). Robinson and O’Keefe fail to teach the female connector. However, Price teaches wherein each electrode [electrode] (Figure 4, Element V4) connector head [cap head] (Figure 3, Element 28) comprises a female connector (as shown in Figure 3) configured to receive and frictionally and/or mechanically engage the protrusion [conductive metal post] (Figure 3, Element 25) in order to have ECG assemblies that are economical to produce (Col. 2, Line 5-8) as integrating wires into vests is more complex and more expensive to manufacture.
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 electrode lead of Robinson and O’Keefe to have a female connector as taught by Price in order to have ECG assemblies that are economical to produce (Col. 2, Line 5-8).
Claim(s) 10-13 & 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Robinson et al. (U.S. Patent Application 2018/0318606 A1) and O’Keefe et al. (U.S. Patent Application 2016/0331321 A1) and further in view of Bao et al. (WO 2017/133226 A1; enclosed herein and English Translation referenced).
Claim 10/1: Robinson teaches –
An electrocardiographic imaging kit (ECGi) [Electrocardiographic Imaging (ECGI)] (Para 0038), comprising:
the ECGi electrode vest of claim 1 (See rejection above of Claim 1);
Robinson and O’Keefe fail to teach the inflatable gilet.
However, Bao teaches –
an inflatable gilet [Airbags (1-1, 1-2, 1-3, 1-4, 1-5, 1-6, 1-7, 1-8)] (Abstract) configured to be worn over the electrode vest [ECG monitoring garment] (Para 0040 and as shown in Figure 2 & 3) during electrophysiological signal acquisition [ECG signal acquisition] (Para 0040) to improve the skin-electrode contact [The gap between the clothes and the human body achieves the purpose of tightness, so that a plurality of conductive airbags located on the chest can collect the ECG signals of the human body, thereby improving the reliability and accuracy of the ECG signal acquisition] (Para 0040) in order to allow for flexible conversion between monitoring and non-monitoring so the patient can comfortably wear the ECG monitor (Para 0040)
Examiner’s Note: The English translation makes clear that gel adhesive is not needed as the electrodes will be pressed to the patient through the inflation of the vest.
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 electrode vest of Robinson and O’Keefe to include the inflatable gilet as taught by Bao in order to allow for flexible conversion between monitoring and non-monitoring so the patient can comfortably wear the ECG monitor (Para 0040).
Claim 11/10/1: Robinson and O’Keefe fail to teach the inflatable gilet.
However, Bao teaches wherein the inflatable gilet [Airbags (1-1, 1-2, 1-3, 1-4, 1-5, 1-6, 1-7, 1-8)] (Abstract) is configured, when worn over the electrode vest [a plurality of airbags may be disposed on the ECG monitoring garment] (Para 0035) and inflated [the airbag string 1 around the front and back of the ECG monitoring garment is inflated, and the inflated airbag itself is filled up] (Para 0040), to exert a compressive force on the electrode vest to bias the electrodes towards a patient's skin surface [The gap between the clothes and the human body achieves the purpose of tightness, so that a plurality of conductive airbags located on the chest can collect the ECG signals of the human body, thereby improving the reliability and accuracy of the ECG signal acquisition] (Para 0040) in order to allow for flexible conversion between monitoring and non-monitoring so the patient can comfortably wear the ECG monitor (Para 0040).
Claim 12/11/10/1: Robinson teaches further comprising a CMR compatible fiducial marker vest for wearing during CMR imaging [cardiovascular magnetic resonance imaging (CMR)] (Para 0040), the fiducial marker vest comprising a layer [wore a vest] (Para 0095) configured to cover at least a patient's chest area [ECGI can utilize an electrode vest strapped to the subject's torso] (Para 0039), and a plurality of fiducial markers distributed over a chest area of the base layer in the same locations as the electrodes of the electrode vest [Patients wore a vest of 256 electrodes (BioSemi, Netherlands) with small radiopaque markers attached at the location of the electrodes to visualize on cardiac imaging] (Para 0095).
Robinson fails to teach the specifics regarding the electrode vest. However, O’Keefe teaches the vest [precordial overlay vest] (Figure 5, Element 200) comprising a flexible base layer [a wearable material, for example, an elastic material, foam, mesh, polymer, composite, or the like] (Para 0033) configured to cover at least a patient's chest area [precordial overlay vest] (Figure 5, Element 200) in order to allow for a reusable vest with adjustable and removeable electrodes for quick and precise placement of the electrodes on to the patient (Para 0035)
Claim 13/10/1: Robinson teaches further comprising a plurality of electrical leads [recording leads on the body surface] (Para 0039 and Figure 1A, Element Multi-channel ECG Mapping & 250 ECGs), an electrode vest [wearing a vest of electrodes] (Para 0038) and ECGi measurement apparatus [noninvasive systems…comprising a noninvasive means…wherein the noninvasive imaging means comprises an electrical potential measuring device and a geometry determining device] (Para 0045).
Robinson and O’Keefe fail to teach the specifics regarding the electrode lead. However, Price teaches each electrical lead [Each electrode assembly comprises an electrode to receive a lead wire] (Abstract) comprising an electrode connector head [cap head] (Figure 3, Element 28) at one end of thereof configured to removably connect with a respective connector portion [conductive metal post] (Figure 3, Element 25) of a respective electrode [electrode] (Figure 4, Element V4) of the electrode band [elongated band] (Figure 3, Element 11) for transmitting electrophysiological signals to an ECGi measurement apparatus (functional claim language carrying little to no patentable weight and the prior art element is capable of performing the function) in order to have ECG assemblies that are economical to produce (Col. 2, Line 5-8) as integrating wires into vests is more complex and more expensive to manufacture.
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 electrode lead of Robinson and O’Keefe to be removeable as taught by Price in order to have ECG assemblies that are economical to produce (Col. 2, Line 5-8).
Claim 17/14/1: Robinson and O’Keefe fail to teach the inflatable gilet.
However, Bao teaches further comprising an inflatable gilet [Airbags (1-1, 1-2, 1-3, 1-4, 1-5, 1-6, 1-7, 1-8)] (Abstract) configured to be worn over the electrode vest [a plurality of airbags may be disposed on the ECG monitoring garment] (Para 0035) during electrophysiological signal acquisition [ECG signal acquisition] (Para 0040) to improve the skin-electrode contact [the airbag string 1 around the front and back of the ECG monitoring garment is inflated, and the inflated airbag itself is filled up] (Para 0040) in order to allow for flexible conversion between monitoring and non-monitoring so the patient can comfortably wear the ECG monitor (Para 0040).
Claim(s) 2 & 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Robinson et al. (U.S. Patent Application 2018/0318606 A1) and O’Keefe et al. (U.S. Patent Application 2016/0331321 A1) and further in view of Khair (U.S. Patent Application 2012/0165633 A1).
Claim 2/1: Robinson fails to teach the specifics with regarding to the electrode vest. O’Keefe teaches integrated electrical leads or traces [lead wires] (Figure 5, Element 282A-282F) in to the electrode vest [precordial overlay vest] (Figure 5, Element 210).
However, Khair teaches wherein the electrode [electrode assembly] (Figure 2, Element 20) does not include any electrical leads or traces [transceiver unit for transmitting and receiving wireless communications] (Para 0020) for conducting the electrophysiological signals [wireless ECG measurement system for use with a patient so as to acquire ECG signals] (Para 0024) from the electrodes [electrode assembly] (Figure 2, Element 20) in order to have ECG assemblies that are economical to produce (Col. 2, Line 5-8) as integrating wires into vests is more complex and more expensive to manufacture.
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 integrated wires of Robinson and O’Keefe to be wireless as taught by Khair in order for measuring of bio-potential electrical activity of the heart that uses measurements obtained across a much smaller separation distance between electrode contact points, but yet retains the presentation of ECG waveforms which corresponds closely to existing ECG measurement standards, thereby preserving the waveform morphology, amplitude, and frequency components (Para 0003).
Examiner’s Note: See 35 USC § 112 rejection above, the Examiner is interpreting the claim limitation as interpretation (2.
Claim 16/14/1: Robinson and O’Keefe fail to teach a signal pre-amplifier. However, Khair teaches wherein each electrode connector head [electronic patch layer] (Figure 2, Element 22) comprises a signal pre-amplifier (Figure 3 show Element 22 of Figure 2 and comprising Element 28a-28d and 30a-30c) in order for measuring of bio-potential electrical activity of the heart that uses measurements obtained across a much smaller separation distance between electrode contact points, but yet retains the presentation of ECG waveforms which corresponds closely to existing ECG measurement standards, thereby preserving the waveform morphology, amplitude, and frequency components (Para 0003).
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 electrode of Robinson and O’Keefe to be have a pre-amplifier as taught by Khair in order for measuring of bio-potential electrical activity of the heart that uses measurements obtained across a much smaller separation distance between electrode contact points, but yet retains the presentation of ECG waveforms which corresponds closely to existing ECG measurement standards, thereby preserving the waveform morphology, amplitude, and frequency components (Para 0003).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Collins et al. (U.S. Patent 3,612,061 A) – Collins teaches a porous sheet of elastic material supports an array of electrodes adapted to contact the wearer's skin. The sheet and electrodes are conformed to the wearer's body configuration by an outer less flexible sheath, interposed resilient material, and adjustable fastening means. The several electrodes are connected to a cable fed with electrical pulses adapted to produce a two-dimensional electrical skin stimulation pattern representing or depicting a visible object
Ryu et al. (U.S. Patent Application 2005/0137472 A1) – Ryu teaches an electrode-connector protecting cap for ambulatory physiological signal measurement comprising a hemisphere cap, a wing positioned at a periphery of the hemisphere cap and having a contact surface connected to the electrode-connector; and an opening for a wire to be passed through and formed in the hemisphere cap, and an electrode-connector including the same, whereby a connection between the electrode and the connector can be protected and the noise occurrence can be prevented.
Yang (U.S. Patent Application 2012/0238845 A1) – Yang teaches an electronic device includes an upper layer made of a non-conductive material; a lower layer made of a non-conductive material, wherein at least one of the upper layer and the lower layer is made of a resilient material having a sufficient elasticity such that it will return to an original shape after being deformed, wherein the upper layer comprises an upper conductor and the lower layer comprises a lower conductor and a space is provided between the upper conductor and the lower conductor such that the upper conductor and the lower conductor are not in contact until a force is applied to deform at least one of the upper layer and the lower layer. A sensor device for human body testing connected with the lower conductor, or the lower conductor is configured to function as part of a sensor device for human body testing.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HELENE C BOR whose telephone number is (571)272-2947. The examiner can normally be reached Mon - Fri 10:30 - 6:30.
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/Helene Bor/Examiner, Art Unit 3797
/CHRISTOPHER KOHARSKI/Supervisory Patent Examiner, Art Unit 3797
1 https://www.merriam-webster.com/medical/precordial