DETAILED ACTION
This action is pursuant to claims filed on 8/16/2024. Claims 1-21 are pending. A first action on the merits of claims 1-21 is as follows.
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 .
Claim Objections
Claims 1, 2, 3, 10, 11, 12 are objected to because of the following informalities: each of the listed claims recites “subset of the electrodes.” This should be corrected to --subset of the plurality of electrodes-- to maintain consistency and make it clear that the subsets of electrodes are from the plurality of electrodes and not other electrodes on the device.
Appropriate corrections are required.
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 20 is 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.
Claim 20 recites “the electrically conductive pathway” in line 1. This statement lacks antecedent basis as it is dependent upon claim 18 and 10 which do not introduce the conductive pathway.
Claim Rejections - 35 USC § 102
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.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-4, 6-12, 14, 17-19, and 21 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Kaib et al. (hereinafter ‘Kaib’, US 20160045156 A1).
Regarding independent claim 1, Kaib discloses a method of sensing electrophysiological signals using dynamically changing lead configurations ([0027]: method of monitoring ECG; [0038]: the method further comprises acts of determining, from the quality of the respective ECG signal provided by a first pairing of ECG sensors of the identified at least one of the plurality of different pairings, that one or more of the ECG sensors of the first pairing may have at least partially lost contact with the body of the patient; selecting another paring of ECG sensors to replace the first pairing of ECG sensors; and monitoring the other pairing of ECG sensors), the method comprising:
providing a garment system (garment 100) having a plurality of electrodes (electrodes 10; [claim 10]: comprising a garment that is configured to be worn about the body of the patient, wherein the plurality of sensing electrodes are attached to the garment), each disposed to contact a respective body portion of a plurality of body portions of a wearer of the garment system (contact the body as seen in Fig. 1; [0043]: Fig. 1A illustrates an electrode system of a portable medical device in which a plurality of ECG sensing electrodes are integrated into a garment, such as a shirt or vest that can be worn on the body of the patient, and in which the electrodes are generally disposed in a plane of the patient’s heart);
sensing electrophysiological signals of the wearer in a first lead configuration of the garment system using a first subset of the electrodes ([claim 1]: instruct the electrode signal acquisition circuit to select at least one of the plurality of different pairings to monitor based upon at least a quality of the respective signal provided by the selected at least one of the plurality of different pairings);
detecting at least one change in contact location between the electrodes and the body portions ([0038]: the method further comprises acts of determining, from the quality of the respective ECG signal provided by a first pairing of ECG sensors of the identified at least one of the plurality of different pairings, that one or more of the ECG sensors of the first pairing may have at least partially lost contact with the body of the patient – a partial loss of contact with the body entails a change in contact location because it is no longer in the exact same spot); and
upon said detecting, sensing further electrophysiological signals of the wearer in a second lead configuration of the garment system using a second subset of the electrodes ([0038]: selecting another paring of ECG sensors to replace the first pairing of ECG sensors; and monitoring the other pairing of ECG sensors; [0078]: Different pairings of ECG sensing electrodes having a similar phase difference, or representing different phase differences may be selected – the claim is written very broadly and “lead configuration” is not defined in the claim so when the subsets of electrodes are different electrodes, different leads can be measured, like when the first pair is on the right side of the body vs the second pair on the left side of the body; when the electrode subsets are the same, they still can move on the body which changes the configuration even if the lead measured might be the same since the electrode placement forms a different configuration), wherein the second lead configuration provides an improved signal quality relative to the first lead configuration ([0076]: the control unit 30 may include a signal acquisition circuit that is capable of selecting, from among the plurality of ECG sensing electrodes 10, those pairs of electrodes that provide the best ECG signals, in terms of signal level, noise, phase discrimination, or any other criteria; [0091]: each time the electrode belt or garment is worn, the electrodes may move to a slightly different location, resulting in a change to the ECG signal. With multiple electrode configurations, the detection system can scan the multiple paths and select the highest quality signals).
Regarding claim 2, Kaib discloses the method of claim 1, wherein the first subset of the electrodes and the second subset of the electrodes are the same ([0102]: the present invention utilizes a selection process to account for any potential repositioning of the electrodes and the electrode system may select those pairings of ECG sensing electrodes that provide the highest quality ECG signals, irrespective of whether those pairings of ECG electrodes are the same, or different from those selected previously – i.e. the subsets are the same if the first subset provides the highest quality signal).
Regarding claim 3, Kaib discloses the method of claim 1, wherein the first subset of the electrodes and the second subset of the electrodes are different ([0102]: the present invention utilizes a selection process to account for any potential repositioning of the electrodes and the electrode system may select those pairings of ECG sensing electrodes that provide the highest quality ECG signals, irrespective of whether those pairings of ECG electrodes are the same, or different from those selected previously – i.e. the subsets are different if a new subset provides the highest quality signal).
Regarding claim 4, Kaib discloses the method of claim 1, wherein the change in contact location includes a change in contact of a given one of the electrodes from a given one of the body portions to a different one of the body portions ([0091]: each time the electrode belt or garment is worn, the electrodes may move to a slightly different location, resulting in a change to the ECG signal. With multiple electrode configuration, the detection system can scan the multiple paths and select the highest quality signal – the claim does not define the body portions so as long as the location changes on the body, it moves from one body portion to another).
Regarding claim 6, Kaib discloses the method of claim 1, wherein said sensing electrophysiological signals includes sensing at least one of ECG, EEG, EMG, EOG, or bioimpedance signals ([0027]: a method for monitoring ECG signals is provided).
Regarding claim 7, Kaib discloses the method of claim 1, further comprising: establishing baseline readings for the wearer based on said sensing in the first lead configuration ([0105]: In act 610 the at least one processor monitors and analyzes selected ECG signals from different pairings of ECG sensing electrodes. The pairings of ECG sensing electrodes that are monitored and analyzed in act 610 may have been previously selected – initial readings are taken from the electrode pairs which serve as the baseline, this includes the first electrode subset as they have changed contact location yet; the claim does not define what the baseline being measured is and is thus interpreted as the initial reading).
Regarding claim 8, Kaib discloses the method of claim 7, further comprising: detecting a deviation from the baseline readings based on said sensing in the first lead configuration ([0105]: In act 620, the at least one processor makes a determination as to whether there is noise in the ECG signal of a selected pairing of ECG sensing electrodes, or whether there has been a fall-off or at least partial loss of contact with the body of the patient by a selected pairing of ECG sensing electrodes. Where it is determined in act 620 that there is no appreciable noise or a diminished signal or a lack of signal on any of the selected pairings of ECG sensing electrodes, the at least one processor returns to act 610 and continues monitoring the selected ECG signals. Alternatively, where it is determined that there is appreciable noise or a diminished signal or lack of signal from one of the selected pairings of ECG sensing electrodes, the process proceeds to act 630 – thus the processor inherently determines whether the signal deviates from the original baseline to determine if an electrode has lost contact; losing contact is a change in location).
Regarding claim 9, Kaib discloses the method of claim 8, further comprising: upon said detecting, providing a notification to the wearer to cause the garment system to transition to the second lead configuration ([0107]: The at least one processor 410 may also send a message to the user of portable medical device (or a bystander) via the user interface 418 to notify the user that one or more of the ECG sensing electrodes of the selected pairing may have a noise issue or may have at least partially lost contact with the body of the patient, and may further request the user to reposition the ECG sensing electrodes of the selected pairing – thus the processor notifies the user to reposition the electrode which would allow it be used in sensing in the second lead configuration – the claim is not specific as to what constitutes transitioning to the second lead configuration or what the second lead configuration even is).
Regarding independent claim 10, Kaib discloses a garment system (garment 100) for sensing electrophysiological signals using dynamically changing lead configurations ([0027]: a method of monitoring ECG signals is provided; [0038]: the method further comprises acts of determining, from the quality of the respective ECG signal provided by a first pairing of ECG sensors of the identified at least one of the plurality of different pairings, that one or more of the ECG sensors of the first pairing may have at least partially lost contact with the body of the patient; selecting another paring of ECG sensors to replace the first pairing of ECG sensors; and monitoring the other pairing of ECG sensors), the system comprising:
a plurality of electrodes (electrodes 10), each disposed to contact a respective body portion of a plurality of body portions of a wearer of the garment system (contact the body as seen in Fig. 1; [0043]: Fig. 1A illustrates an electrode system of a portable medical device in which a plurality of ECG sensing electrodes are integrated into a garment, such as a shirt or vest that can be worn on the body of the patient, and in which the electrodes are generally disposed in a plane of the patient’s heart);
wherein the garment system is operable to:
sense electrophysiological signals of the wearer in a first lead configuration using a first subset of the electrodes ([claim 1]: instruct the electrode signal acquisition circuit to select at least one of the plurality of different pairings to monitor based upon at least a quality of the respective signal provided by the selected at least one of the plurality of different pairings);
detect at least one change in contact location between the electrodes and the body portions ([0038]: the method further comprises acts of determining, from the quality of the respective ECG signal provided by a first pairing of ECG sensors of the identified at least one of the plurality of different pairings, that one or more of the ECG sensors of the first pairing may have at least partially lost contact with the body of the patient – a partial loss of contact with the body entails a change in contact location because it is no longer in the exact same spot); and
sense further electrophysiological signals of the wearer in a second lead configuration using a second subset of the electrodes ([0038]: selecting another paring of ECG sensors to replace the first pairing of ECG sensors; and monitoring the other pairing of ECG sensors; [0078]: Different pairings of ECG sensing electrodes having a similar phase difference, or representing different phase differences may be selected – the claim is written very broadly and “lead configuration” is not defined in the claim so when the subsets of electrodes are different electrodes, different leads can be measured, like when the first pair is on the right side of the body vs the second pair on the left side of the body; when the electrode subsets are the same, they still can move on the body which changes the configuration even if the lead measured might be the same since the electrode placement forms a different configuration), wherein the second lead configuration provides an improved signal quality relative to the first lead configuration ([0076]: the control unit 30 may include a signal acquisition circuit that is capable of selecting, from among the plurality of ECG sensing electrodes 10, those pairs of electrodes that provide the best ECG signals, in terms of signal level, noise, phase discrimination, or any other criteria; [0091]: each time the electrode belt or garment is worn, the electrodes may move to a slightly different location, resulting in a change to the ECG signal. With multiple electrode configurations, the detection system can scan the multiple paths and select the highest quality signals).
Regarding claim 11, Kaib discloses the system of claim 10, wherein the first subset of the electrodes and the second subset of the electrodes are the same ([0102]: the present invention utilizes a selection process to account for any potential repositioning of the electrodes and the electrode system may select those pairings of ECG sensing electrodes that provide the highest quality ECG signals, irrespective of whether those pairings of ECG electrodes are the same, or different from those selected previously – i.e. the subsets are the same if the first subset provides the highest quality signal).
Regarding claim 12, Kaib discloses the system of claim 10, wherein the first subset of the electrodes and the second subset of the electrodes are different ([0102]: the present invention utilizes a selection process to account for any potential repositioning of the electrodes and the electrode system may select those pairings of ECG sensing electrodes that provide the highest quality ECG signals, irrespective of whether those pairings of ECG electrodes are the same, or different from those selected previously – i.e. the subsets are different if a new subset provides the highest quality signal).
Regarding claim 14, Kaib discloses the system of claim 10, wherein at least one of the electrodes is disposed on an interior garment surface ([0071]: the electrodes are integrated into a garment such as a belt worn over the torso of a patient and the ECG electrodes are distributed around the torso; [0084]: the electrodes are intended to contact the body of the patient; [0066]: the plurality of ECG electrodes can be conductive electrodes – thus, the electrodes inherently are on the inside of the garment if they are conductive electrodes that contact the torso of the user).
Regarding claim 17, Kaib discloses the system of claim 10, further comprising a contact surface for a hand of the wearer that is removably attachable to a garment ([0066]: the electrodes can be attached to the garment by hook and loop fastener – the user can grab any electrode with their hand as that is intended use and the hook and loop fastener allows the electrodes to be removable and attachable).
Regarding claim 18, Kaib discloses the system of claim 10, further comprising a controller operable to process the electrophysiological signals and the further electrophysiological signals ([0092]: the control unit 30 comprises a processor; [0095]: the critical purpose of the processor is configured to perform critical functions that require real time processing, such as the sampling and analysis of ECG information).
Regarding claim 19, Kaib discloses the system of claim 18, wherein the controller is communicatively coupled to at least one of the electrodes by way of an electrically conductive pathway ([0067]: Insulated lead wires 15 electrically couple each ECG sensing electrode of the plurality of ECG sensing electrodes 10 to a control unit 30).
Regarding claim 21, Kaib discloses the garment system of claim 18, wherein the plurality of electrodes includes a textile electrode formed of conductive yarn ([0066]: some or all of the electrodes may be formed from electrically conductive threads sewn into the garment).
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.
Claim(s) 5, 13, 15, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Kaib as applied to claims 1 and 10, respectively, and described above, in view of Freeman et al. (hereinafter ‘Freeman’, US 20220008715 A1).
Regarding claim 5, Kaib discloses the method of claim 1 as described above. Kaib further discloses that the electrodes may move to different locations, resulting in a change in ECG signal ([0091]). Donning and adjusting the belt is inherently done by the hands and it is possible for an individual to touch individual electrodes with their hands to move them.
However, Kaib does not explicitly state the electrode locations are adjusted with the hands of the user.
Freeman teaches a garment configured to be worn continuously around a torso of a patient with a plurality of ECG measurement electrodes supported by the garment to monitor ECG signals of the patient ([claim 66]). Similar to Kaib, the sensor interface 212 may identify one or more optimal pairings of sensing electrodes 112 and control a state of the multiplexer to receive ECG signals from the identified pairings ([0201]). Freeman further that the user can interact with and adjust the device while worn and the device includes elements that enable adjusting the locations of one or more of the sensing electrodes ([0152]). The ability to adjust portions of the garment aid in increasing comfort and ease of user ([0152]). The device allows for the disengagement of sensor electrodes by the user prior to the expiration of a prescribed duration of wear ([0248]). This is inherently caused by a hand touching or adjusting the electrodes which would change location of the electrode. Thus, when the first subset of electrodes is touched and moved by the hand, a hand comes into contact with the electrodes during the change in contact location portion. The claims do not require that the hand must stay in contact with the electrode during the second sensing phase. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to utilize the ability to change the locations of the electrodes, which is inherently caused by the hand of the user, as taught by Freeman to enhance the comfort of the device of Kaib.
Regarding claim 13, Kaib discloses the system of claim 10 as described above. Kaib further discloses that the electrodes can be attached to the garment in a variety of ways such as hook and loop fasteners and magnets ([0066]).
However, Kaib is silent to the at least one of the electrodes is disposed in a garment pocket.
Freeman teaches a garment configured to be worn continuously around a torso of a patient with a plurality of ECG measurement electrodes supported by the garment to monitor ECG signals of the patient ([claim 66]). Similar to Kaib, the sensor interface 212 may identify one or more optimal pairings of sensing electrodes 112 and control a state of the multiplexer to receive ECG signals from the identified pairings ([0201]). In order to attach the electrodes to the garment, the garment may include pockets for receiving the sensing electrodes ([0192]). The pockets are shaped and sized to allow the electrodes to fit in the receptables in only one direction and orientation ([0193]). Also similar to Kaib, Freeman teaches that other methods of electrode attachment such as hook and loop fasteners, magnets, and other restraints may be used ([0162]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to substitute the pockets of Freeman for the attachment mechanism of Kaib since Freeman teaches they are equivalent in the art and the pockets provide for orientation control of the electrodes.
Regarding claim 15, Kaib discloses the system of claim 10, wherein at least one of the electrodes is disposed on an exterior garment surface (the claim does not define what the interior and exterior of the garment are or whether the garment is being worn in relation to the surfaces, so it is interpreted as a side facing away from the body when the system is not in use; the straps in the harness shown in Fig. 1E are capable of being flipped so that the electrodes are then on an exterior surface of the garment because it faces away from the body.
While it is the examiner’s opinion that Kaib discloses the claim as written and broadly interpreted, Freeman further teaches this limitation.
Freeman further teaches that the sensing electrodes 112 may be mounted to an inner surface of the garment or an outer surface of the garment ([0227]). Modifying the location of the electrodes on the garment is well within the level of ordinary skill in the art and changing the mounting surface of the electrodes would maintain functionality of Kaib since Freeman discloses utilizing electrode pairs to measure ECG ([0201]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to move at least one electrode from an interior surface to an outer surface as taught by Freeman, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
Regarding claim 16, Kaib discloses the system of claim 10 as described above. Kaib further discloses the harness includes an adjustable belt ([0072]).
However, while the electrodes of Kaib are arranged around the belt as seen in Fig. 1E, Kaib does not show that the belt is made of flaps that can be manipulated between interior and exterior positions.
Freeman further teaches where the belt is made of flaps on which the electrodes are disposed as seen in Fig. 12B. The garment of Freemen includes adjustable and disengageable straps ([0034]). Forming flaps like those shown in Fig. 12A and B of Freemen into the belt of Kaib would be of routine skill in the art and provide for an adjustable and disengageable connection. Furthermore, the flap with the sensing electrodes can be located on an interior of the garment when covered by the other flap, and can be located on the exterior of the garment when it covers the other flap. The claim does not provide any specificity to the flap, the electrode moving from interior to exterior positions, or if the device is actually operating when the flap is adjusted. Therefore, it would have been obvious to one of ordinary skill in the art prior to the filing date of the instant application to utilize flaps such as those taught by Freemen on the belt of Kaib to provide an adjustable and disengageable attachment means for the belt, resulting in the claimed configuration and functionality.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Kaib as applied to claim 10 and described above, in view of Mrvaljevic (US 20230157605 A1).
Regarding claim 20, Kaib discloses the system of claim 18 as described above. Kaib further discloses that the sensing electrodes are connected to the control unit by wires, but the invention is not so limited ([0066]). Kaib further contemplates the use of conductive thread to form the electrodes ([0066]: some or all of the electrodes may be formed from electrically conductive threads sewn into the garment).
However, Kaib is silent to the electrically conductive pathway is formed of conductive yarn.
Mrvaljevic teaches clothing that are equipped with sensors to determine the load expended by a user ([0008]). The clothing can comprise ECG sensors 202a and EMG sensors 202b as seen in Figs. 1 and 2 ([0021]). These sensors are operationally connected to a controller utilizing thin, resilient flexible wires and/or conductive thread woven into the clothing ([0021]). Mrvaljevic clearly teaches that conductive thread is a known substitute for wires for connecting ECG sensors to a controller in an ECG sensing garment. The substitution of one known element (the conductive yarn of Mrvaljevic) for another (the wires of Kaib) would have been obvious to one of ordinary skill in the art at the time of the invention since the substitution of the conductive yarn would have yielded predictable results, namely, an electrical connection between the electrodes and the controller for the transmission of sensed signals.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM E MOSSBROOK whose telephone number is (703)756-1936. The examiner can normally be reached M-F 8-5.
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/LINDA C DVORAK/Primary Examiner, Art Unit 3794
/W.M./Examiner, Art Unit 3794
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