Office Action 3: Non-Final Rejection (2024-06-07)
Rejection types: 103 - Obviousness

CLAIMS:
AMENDMENTS TO THE CLAIMS

The listing of claims will replace all prior versions, and listings, of claims in the application:

Listing of Claims:

1-10. (Canceled)29

11\. (Currently Amended) A smart garment for detecting physiological data of a user, the smart garment comprising:a garment configured to be worn on an upper body of the user,
a plurality of textile-based ECG electrodes, wherein each of the plurality of textile-based ECG electrodes comprises interlaced conductive fibers for conducting a plurality of ECG signals with respect to the upper body of the user while in contact with skin of the user;
wherein the plurality of textile-based ECG electrodes includes at least one textile-based ECG generator electrode for transmitting a generated signal through the ser's skin, and at least one textile-based ECG receiver electrode, spaced apart from the textile-based ECG generator electrode, for sensing the generated signal through the user's skin,
a controller device electronically coupled to the plurality of textile-based ECG electrodes, the controller device configured to:
generate the generated signal,
transmit the generated signal through the at least one textile-based ECG generator electrode,
sense a collected signal from the at least one textile-based ECG generator electrode via the one or more textile-based ECG receiver electrodes,
based on the collected signal, determine at least one of the plurality of textile-based ECG electrodes (i) is at least partially out of contact with the skin of the user and/or (ii) causes the generated signal that is transmitted through the at least one of the textile-based ECG generator electrode to be of unacceptable signal quality,
deselect the at least one determined textile-based ECG electrode, and select at least another one of the plurality of textile-based ECG electrodes, and

repeat said generate and said sense of the generated signal using the at least another one of the plurality of textile-based ECG electrodes.

12\. (Previously Presented) The smart garment of claim 11, wherein the controller determines a percentage of contact surface area of one or more of the plurality of textile-based ECG electrodes with the skin of the user.

13\. (Previously Presented) The smart garment of claim 11, wherein the controller detects whether one or more of the plurality of textile-based ECG electrodes are in acceptable contact with the skin of the user.

14\. (Previously Presented) The smart garment of claim 11, further comprising monitoring a signal quality of the generated signal and repeating the process of deselecting the determined textile-based ECG electrode and selecting a different textile-based ECG electrode as a result of said monitoring.

15\. (Previously Presented) The smart garment of claim 11, wherein the interlaced conductive fibers comprise conductive yarns.

16\. (Previously Presented) The smart garment of claim 15, wherein the conductive yarns are knitted into the ECG electrode.

17\. (Previously Presented) The smart garment of claim 11, wherein the controller determines a change in a desired location of one or more of the plurality of the textile-based ECG electrodes.

18\. (Previously Presented) The smart garment of claim 11, further comprising a plurality of the ECG generator electrodes and plurality of the ECG receiver electrodes.

19\. (Previously Presented) The smart garment of claim 18, wherein the generated signal is generated using a given generator electrode of the plurality of textile-based ECG generator electrodes and the collected signal is sensed using a given receiver electrode of the plurality of textile-based ECG receiver electrodes.

20\. (Previously Presented) The smart garment of claim 19, wherein the controller is configured to determine whether the generated signal generated using the given generator electrode and the collected signal sensed using the given receiver electrode does not satisfy a quality threshold, and selects an alternative generator electrode and/or an alternative receiver electrode.

21\. (Previously Presented) The smart garment of claim 20, wherein the controller continues selecting alternative generator electrodes and/or alternative receiver electrodes to choose a generator electrode and receiver electrode pairing that satisfies a signal quality threshold.

22\. (Previously Presented) The smart garment of claim 11, wherein the garment includes a belt portion having at least one of the plurality of textile-based ECG electrodes.

23\. (Previously Presented) The smart garment of claim 11, wherein the interlaced conductive fibers are formed by weaving electrically conductive threads.

24\. (Previously Presented) The smart garment of claim 11, wherein the controller uses physiological data sensed by the plurality of textile-based ECG electrodes to determine a quantity of the user selected from the group consisting of: a PR interval, a QT interval, a corrected QT (QTc) interval, a PR axis, and a QRS axis.

25\. (Previously Presented) The smart garment of claim 11, wherein the plurality of textile-based ECG electrodes are exposed on a first side and insulated on a second side.

26\. (Previously Presented) The smart garment of claim 11, wherein the interlaced conductive fibers are interlaced with non-conductive fibers of a body of the smart garment.

27\. (Previously Presented) The smart garment of claim 11, further comprising a conductive trace connected to the each of the plurality of textile-based ECG electrodes, each of the conductive traces for connecting the plurality textile-based ECG electrodes to the controller for sending and receiving one or more electronic signals using the plurality of textile-based ECG electrodes.

28\. (Previously Presented) The smart garment of claim 27, wherein the controller alternates different pairings chosen from the plurality of textile-based ECG electrodes as one or more selected pairs in order to determine a decided optimum signal from the one or more electronic signals received from the different pairings.

29\. (Currently Amended) A smart garment for detecting physiological data of a user, the smart garment comprising:a plurality of textile-based ECG electrodes, wherein each of the plurality of textile-based ECG electrodes comprises interlaced conductive fibers for conducting a plurality of ECG signals with respect to a body of the user;
wherein the plurality of textile-based ECG electrodes includes at least one textile-based ECG generator electrode for transmitting a generated signal through the ser's skin, and at least one textile-based ECG receiver electrode spaced apart from the textile-based ECG generator electrode for sensing the generated signal through the user's skin,
a controller device electronically coupled to the plurality of textile-based ECG electrodes, the controller device configured to:
generate the generated signal,
transmit the generated signal through the at least one textile-based ECG generator electrode,
sense a collected signal via one or more textile-based ECG receiver electrodes,

based on the collected signal, determine at least one of the plurality of textile- based ECG electrodes (i) is at least partially out of contact with skin of the user and/or (ii) causes the generated signal that is transmitted through the at least one ECG generator electrode to be of unacceptable signal quality,
deselect the at least one determined textile-based ECG electrode, and select at least another one of the plurality of textile-based ECG electrodes, and
repeat said generate and said sense of the generated signal using the at least another one of the plurality of textile-based ECG electrodes.

30\. (Currently Amended) The smart garment of claim 112wherein the controller device is configured to process the collected signal to analyze the physiological data to determine a defined health event of the user.

OFFICE ACTION:
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 .
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 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.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection.  Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.  Applicant's submission filed on 10 May 2024 has been entered.
Status of Claims
Claims 11-30 are pending and currently under consideration for patentability; claims 11, 29, and 30 have been amended; claims 1-10 previously were cancelled.
Information Disclosure Statement
The Information Disclosure Statement submitted on 10 May 2024 has been acknowledged and considered by the Examiner.
Response to Arguments
Applicant’s arguments dated 02 May 2024 have been fully considered, but they are not persuasive or moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant presents a number of arguments regarding the Jain reference as applied in the previous Office Action.  The Examiner respectfully submits that the Jain reference has not been used in the current rejection, as described below, rendering the corresponding arguments moot.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 11-16, 18-23, and 25-30 are rejected under 35 U.S.C. 103 as being unpatentable over Chahine et al. (US 2017/0056644 A1) in view of Chen et al. (US 2010/0041975 A1).
Regarding claim 11, Chahine describes a smart garment for detecting physiological data of a user ([0020]), the smart garment comprising
a garment configured to be worn on an upper body of the user ([0039])
a plurality of textile-based electrodes, wherein each of the plurality of textile-based electrodes comprises interlaced conductive fibers for conducting a plurality of signals with respect to the upper body of the user while in contact with skin of the user ([0022], [0050], [0192])
wherein the plurality of textile-based electrodes includes at least one textile-based generator electrode for transmitting a generated signal through the user’s skin and at least one textile-based receiver electrode spaced apart from the textile-based generator electrode for sensing the generated signal through the user’s skin ([0004], [0151])
a controller device electronically coupled to the plurality of textile-based electrodes ([0004], [0026]), the controller device configured to
generate the generated signal ([0004], [0026])
transmit the generated signal through at least one generator electrode ([0004], [0026])
sense a collected signal from the at least one textile-based generator electrode via the one or more textile-based receiver electrodes ([0020])
Regarding claim 11, Chahine does not explicitly disclose wherein the textile-based electrodes are ECG electrodes, and Chahine does not explicitly disclose wherein the controller device is configured to
based on the collected signal, determine at least one of the plurality of textile-based ECG electrodes (i) is at least partially out of contact with the skin of the user and/or (ii) causes the generated signal that is transmitted through the at least one of the textile-based ECG generator electrode to be of unacceptable signal quality
deselect the at least one determined textile-based ECG electrode, and select at least another one of the plurality of textile-based ECG electrodes
repeat said generate and said sense of the generated signal using the at least another one of the plurality of textile-based ECG electrodes
However, Chen also describes a smart garment for detecting physiological data of a user ([0030] - [0031]), including a plurality of ECG electrodes ([0030]) and a controller device configured to
based on a collected signal, determine at least one of a plurality of ECG electrodes is at least partially out of contact with the skin of the user and/or causes the generated signal that is transmitted through at least one ECG generator electrode to be of unacceptable signal quality ([0011], [0041])
deselect the at least one determined ECG electrode and select at least another one of the plurality of ECG electrodes ([0044] - [0045])
repeat said generate and said sense of the generated signal using the at least another one of the plurality of ECG electrodes ([0045] - [0046])
As Chen is also directed towards detecting physiological data of a user and is in a similar field of endeavor, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to incorporate a signal quality detection component similar to that described by Chen when using the electrodes described by Chahine, as doing so advantageously ensures that the measured physiological data is of acceptable quality for further analysis.
Regarding claim 12, Chen describes wherein the controller determines a percentage of contact surface area of one or more of the plurality of textile-based ECG electrodes with the skin of the user ([0046]).
Regarding claim 13, Chen describes wherein the controller detects whether one or more of the plurality of textile-based ECG electrodes are in acceptable contact with the skin of the user ([0041]).
Regarding claim 14, Chen describes monitoring a signal quality of the generated signal and repeating the process of deselecting the determined textile-based ECG electrode and selecting a different textile-based ECG electrode as a result of said monitoring ([0045] - [0046]).
Regarding claim 15, Chahine describes wherein the interlaced conductive fibers comprise conductive yarns ([0104]).
Regarding claim 16, Chahine describes wherein the conductive yarns are knitted into the electrode ([0148]), and Chen describes wherein the electrode is an ECG electrode ([0044]).
Regarding claim 18, Chen describes a plurality of the ECG generator electrodes and plurality of the ECG receiver electrodes ([0009], [0038]).
Regarding claim 19, Chen describes wherein the generated signal is generated using a given generator electrode of the plurality of textile-based ECG generator electrodes and the collected signal is sensed using a given receiver electrode of the plurality of textile-based ECG receiver electrodes ([0009], [0038]).
Regarding claim 20, Chen describes wherein the controller is configured to determine whether the generated signal generated using the given generator electrode and the collected signal sensed using the given receiver electrode does not satisfy a quality threshold, and selects an alternative generator electrode and/or an alternative receiver electrode ([0041] - [0042], [0044] - [0046], automatic electrode selection algorithm and electrode switching steps as described).
Regarding claim 21, Chen describes wherein the controller continues selecting alternative generator electrodes and/or alternative receiver electrodes to choose a generator electrode and receiver electrode pairing that satisfies a signal quality threshold ([0041] - [0042], [0044] - [0046], automatic electrode selection algorithm and electrode switching steps as described).
Regarding claim 22, Chahine describes wherein the garment includes a belt portion having at least one of the plurality of textile-based electrodes (figures 32-34, “band” configuration).
Regarding claim 23, Chahine describes wherein the interlaced conductive fibers are formed by weaving electrically conductive threads ([0097]).
Regarding claim 25, Chahine describes wherein the plurality of textile-based ECG electrodes are exposed on a first side and insulated on a second side ([0101]).
Regarding claim 26, Chahine describes wherein the interlaced conductive fibers are interlaced with non-conductive fibers of a body of the smart garment ([0108], [0110]).
Regarding claim 27, Chahine describes a conductive trace connected to the each of the plurality of textile-based electrodes, each of the conductive traces for connecting the plurality textile-based electrodes to the controller for sending and receiving one or more electronic signals using the plurality of textile-based electrodes ([0050]).
Regarding claim 28, Chen describes wherein the controller alternates different pairings chosen from the plurality of textile-based ECG electrodes as one or more selected pairs in order to determine a decided optimum signal from the one or more electronic signals received from the different pairings ([0042]).
Regarding claim 29, Chahine describes a smart garment for detecting physiological data of a user ([0020]), the smart garment comprising
a plurality of textile-based electrodes, wherein each of the plurality of textile-based electrodes comprises interlaced conductive fibers for conducting a plurality of signals with respect to a body of the user ([0050])
wherein the plurality of textile-based electrodes includes at least one textile-based generator electrode for transmitting a generated signal through the user’s skin and at least one textile-based receiver electrode spaced apart from the textile-based generator electrode for sensing the generated signal through the user’s skin ([0004], [0151])
a controller device electronically coupled to the plurality of textile-based electrodes ([0004], [0026]), the controller device configured to
generate the generated signal ([0004], [0026])
transmit the generated signal through the at least one textile-based generator electrode ([0004], [0026])
sense a collected signal via one or more textile-based receiver electrodes ([0020])
Regarding claim 29, Chahine does not explicitly disclose wherein the textile-based electrodes are ECG electrodes, and Chahine does not explicitly disclose wherein the controller device is configured to
based on the collected signal, determine at least one of the plurality of textile-based ECG electrodes (i) is at least partially out of contact with skin of the user and/or (ii) causes the generated signal that is transmitted through the at least one ECG generator electrode to be of unacceptable signal quality
deselect the at least one determined textile-based ECG electrode, and select at least another one of the plurality of textile-based ECG electrodes
repeat said generate and said sense of the generated signal using the at least another one of the plurality of textile-based ECG electrodes
However, Chen also describes a smart garment for detecting physiological data of a user ([0030] - [0031]), including a plurality of ECG electrodes ([0030]) and a controller device configured to
based on a collected signal, determine at least one of a plurality of ECG electrodes is at least partially out of contact with the skin of the user and/or causes the generated signal that is transmitted through at least one ECG generator electrode to be of unacceptable signal quality ([0011], [0041])
deselect the at least one determined ECG electrode and select at least another one of the plurality of ECG electrodes ([0044] - [0045])
repeat said generate and said sense of the generated signal using the at least another one of the plurality of ECG electrodes ([0045] - [0046])
As Chen is also directed towards detecting physiological data of a user and is in a similar field of endeavor, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to incorporate a signal quality detection component similar to that described by Chen when using the electrodes described by Chahine, as doing so advantageously ensures that the measured physiological data is of acceptable quality for further analysis.
Regarding claim 30, Chen describes wherein the controller device is configured to process the collected signal to analyze the physiological data to determine a defined health event of the user ([0003], diagnosing the physiological status and health of an individual).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Chahine in view of Chen, further in view of Kaib et al. (US 2011/0288605 A1).
Regarding claim 17, Chahine in view of Chen suggests the smart garment of claim 11, but neither Chahine nor Chen explicitly disclose wherein the controller determines a change in a desired location of one or more of the plurality of the textile-based ECG electrodes.  However, Kaib also describes a smart garment for detecting physiological data of a user ([0008]), including a controller configured to determine a change in a location of one or more of a plurality of textile-based electrodes ([0091], determining if the electrodes have shifted or moved to a slightly different location).  As Kaib is also directed towards detecting physiological data of a user and is in a similar field of endeavor, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to use Kaib’s feature of determining whether electrodes have changed locations when using the system described by Chahine and Chen, as doing so advantageously allows the resulting system to account for the electrode movements and select a different set of electrodes, if necessary, in order to obtain the highest quality ECG signal.
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Chahine in view of Chen, further in view of Rapin et al. (US 2019/0223739 A1).
Regarding claim 24, Chahine in view of Chen suggests the smart garment of claim 11, but neither Chahine nor Chen explicitly disclose wherein the controller uses physiological data sensed by the plurality of textile-based ECG electrodes to determine a quantity of the user selected from the group consisting of a PR interval, a QT interval, a corrected QT (QTc) interval, a PR axis, and a QRS axis.  However, Rapin also describes analyzing ECG data for monitoring a user’s health ([0002]), including using a controller to determine a PR interval, a QT interval, a corrected QT (QTc) interval, a PR axis, and/or a QRS axis of a user ([0020], [0060]).  As Rapin is also directed towards using ECG data for health analysis and is in a similar field of endeavor, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to use measures similar to those described by Rapin when analyzing the data generated by the textile-based ECG electrodes suggested by Chahine and Chen, as doing so advantageously allows the resulting system to better characterize a patient’s health status and suggest corrective action when necessary.
Statement on Communication via Internet
Communications via Internet e-mail are at the discretion of the applicant.  Without a written authorization by applicant in place, the USPTO will not respond via Internet e-mail to any Internet correspondence which contains information subject to the confidentiality requirement as set forth in 35 U.S.C. 122.  Where a written authorization is given by the applicant, communications via Internet e-mail, other than those under 35 U.S.C. 132 or which otherwise require a signature, may be used.  USPTO employees are NOT permitted to initiate communications with applicants via Internet e-mail unless there is a written authorization of record in the patent application by the applicant.  The following is a sample authorization form which may be used by applicant:
“Recognizing that Internet communications are not secure, I hereby authorize the USPTO to communicate with the undersigned and practitioners in accordance with 37 CFR 1.33 and 37 CFR 1.34 concerning any subject matter of this application by video conferencing, instant messaging, or electronic mail. I understand that a copy of these communications will be made of record in the application file.”
Please refer to MPEP 502.03 for guidance on Communications via Internet.
Conclusion

APPLICANT REBUTTAL: REMARKS
Claims 1-10 were previously canceled. Claims 11-30 are currently pending. Claims 11, 14, 18, 19, 20, 29, and 30 are currently amended.
35 USC
Claims 11-16, 18-23, and 25-30 are rejected as being unpatentable over Chahine et al. (US 2017/0056644) in view of Chen et al. (US 2010/0041975).
1. Chen does not teach or suggest "sense the generated signal from the at least one textile- based ECG generator electrode via the one or more textile-based ECG receiver electrode" as
recited by amended claims 11 and 29.
The present claims require a textile-based ECG electrode pairing having a textile-based ECG generator electrode
that generates
the generated signal, and a textile-based ECG receiver electrode that senses the generated signal.
Chen, paragraph [0046], describes: an "automatic selection process involves two steps in determining which electrodes to select to generate physiological data. First, the system searches electrode connections until it determines that a patient has come into contact with selected electrodes. Then, the processability and/or quality of the signal acquired is accessed."
The foregoing paragraph of Chen, describes a process of selecting
sensing
electrodes based on patient
"
phy
sio
logical
data."
As such, Chen does not describe generating the generated signal, transmitting the generated signal through the at least one textile-based ECG generator electrode, and sensing the generated signal from the at least one textile-based ECG generator electrode via the one or more at least one textile-based ECG receiver electrode.
At least for this reason, claims 11 and 29 are considered to be patentable over the cited art.
2. Chen does not teach or suggest "based on sensing the generated signal... deselect the at least
one determined textile-based ECG electrode from the electrode pairing, and select another
textile-based ECG electrode pairing, repeat said generate and said sense of the generated
signal using the another textile-based ECG electrode pairing" as recited by amended claims
11 and 29.
Claim 11 as amended requires certain steps in response to sensing the generated signal. In particular, deselecting the ECG electrode pairing, selecting another ECG electrode pairing, and repeating the process of generating and sensing the generated signal using the another electrode pairing. As discussed above, Chen does not have a generator electrode, and therefore, fails to teach the claimed ECG electrode pairing.
Furthermore, even if Chen is understood to have taught or suggested the claimed textile- based ECG generator electrode, there is no teaching or suggestion of: based on sensing the generated signal via the at least one textile-based ECG receiver electrode, determining that the at least one textile-based ECG generator electrode and/or the at least one textile-based receiver electrode of the textile-based ECG electrode pairing (i) is at least partially out of contact with the skin of the user and/or (ii) causes the generated signal that is transmitted through the at least one of the textile-based ECG generator electrode to be of unacceptable signal quality,
At least for this reason, claims 11 and 29 are considered to be patentable over the cited art.
CONCLUSION

NEXT OFFICE ACTION: DETAILED ACTION
This office action is in response to the communication dated 27 September 2024 concerning Application No. 18/081,984 filed on 15 December 2022.
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 .
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 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.
Status of Claims
Claims 11-30 are pending and currently under consideration for patentability; claims 11, 14, 18-20, 29, and 30 have been amended; claims 1-10 previously were cancelled.
Response to Arguments
Applicant’s arguments dated 27 September 2024 have been fully considered, but they are not persuasive or moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
The Examiner has addressed the amended limitations in the updated text of the rejection below.
Applicant argues that “Chen does not teach or suggest sense the generated signal from the at least one textile- based ECG generator electrode via the one or more textile-based ECG receiver electrode as recited by amended claims 11 and 29” (Arguments, p. 7).  The Examiner has addressed the amended limitations in the updated text below.  The Examiner also respectfully notes that the Chahine reference, not Chen, was used to teach or suggest similar limitations in the previous Office Action.
Applicant argues that “Chen does not teach or suggest based on sensing the generated signal... deselect the at least one determined textile-based ECG electrode from the electrode pairing, and select another textile-based ECG electrode pairing, repeat said generate and said sense of the generated signal using the another textile-based ECG electrode pairing as recited by amended claims 11 and 29” (Arguments, pp. 7-8).  The Examiner has addressed the amended limitations in the updated text below.  Regarding the non-amended portions of the limitations, the Examiner respectfully disagrees and directs Applicant at least to Chen’s paragraphs [0044] - [0046] and [0048], which describe an electrode selection algorithm which changes the sensing electrodes if it is determined that the signal quality is low, for example by considering “contact between the skin and the electrodes” (Chen, [0046]).  Therefore, the Examiner respectfully maintains that Chen describes deselecting one electrode and selecting a different electrode based on the sensed signal.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 11-16, 18-23, and 25-30 are rejected under 35 U.S.C. 103 as being unpatentable over Chahine et al. (US 2017/0056644 A1) in view of Chen et al. (US 2010/0041975 A1).
Regarding claim 11, Chahine describes a smart garment for detecting physiological data of a user ([0020]), the smart garment comprising
a garment configured to be worn on an upper body of the user ([0039])
a plurality of textile-based electrodes, wherein each of the plurality of textile-based electrodes comprises interlaced conductive fibers for conducting a plurality of signals with respect to the upper body of the user while in contact with skin of the user ([0022], [0050], [0192])
wherein the plurality of textile-based electrodes includes a textile-based ECG electrode pairing ([0026], [0028]) comprising at least one textile-based generator electrode for transmitting a generated signal through the skin of the user and at least one textile-based receiver electrode spaced apart from the textile-based generator electrode for sensing the generated signal through the user’s skin ([0004], [0151])
a controller device electronically coupled to the plurality of textile-based electrodes ([0004], [0026]), the controller device configured to
generate the generated signal ([0004], [0026])
transmit the generated signal through at least one generator electrode ([0004], [0026])
sense the generated signal from the at least one textile-based generator electrode via the at least one textile-based receiver electrodes ([0020])
Regarding claim 11, Chahine does not explicitly disclose wherein the textile-based electrodes are ECG electrodes, and Chahine does not explicitly disclose wherein the controller device is configured to
based on sensing the generated signal via the at least one textile-based ECG receiver electrode, determine that the at least one textile-based ECG generator electrode and/or the at least one textile-based ECG receiver electrode of the textile-based ECG electrode pairing (i) is at least partially out of contact with the skin of the user and/or (ii) causes the generated signal that is transmitted through the at least one of the textile-based ECG generator electrode to be of unacceptable signal quality
deselect the at least one textile-based ECG generator electrode and/or the at least one textile-based ECG receiver electrode of the textile-based ECG electrode pairing, and select another textile-based ECG electrode pairing
repeat said generating and said sensing of the generated signal using the another textile-based ECG electrode pairing
However, Chen also describes a smart garment for detecting physiological data of a user ([0030] - [0031]), including a plurality of ECG electrodes ([0030]) and a controller device configured to
based on sensing a generated signal via at least one textile-based ECG receiver electrode, determine that the at least one textile-based ECG generator electrode and/or the at least one textile-based ECG receiver electrode of the textile-based ECG electrode pairing is at least partially out of contact with the skin of the user and/or causes the generated signal that is transmitted through at least one ECG generator electrode to be of unacceptable signal quality ([0011], [0041])
deselect the at least one textile-based ECG generator electrode and/or the at least one textile-based ECG receiver electrode of the textile-based ECG electrode pairing, and select another textile-based ECG electrode pairing ([0044] - [0045])
repeat said generating and said sensing of the generated signal using the another textile-based ECG electrode pairing ([0045] - [0046])
As Chen is also directed towards detecting physiological data of a user and is in a similar field of endeavor, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to incorporate a signal quality detection component similar to that described by Chen when using the electrodes described by Chahine, as doing so advantageously ensures that the measured physiological data is of acceptable quality for further analysis.
Regarding claim 12, Chen describes wherein the controller determines a percentage of contact surface area of one or more of the plurality of textile-based ECG electrodes with the skin of the user ([0046]).
Regarding claim 13, Chen describes wherein the controller detects whether one or more of the plurality of textile-based ECG electrodes are in acceptable contact with the skin of the user ([0041]).
Regarding claim 14, Chen describes monitoring a signal quality of the generated signal and repeating deselecting the determined textile-based ECG electrode and selecting a different textile-based ECG electrode as a result of said monitoring ([0045] - [0046]).
Regarding claim 15, Chahine describes wherein the interlaced conductive fibers comprise conductive yarns ([0104]).
Regarding claim 16, Chahine describes wherein the conductive yarns are knitted into the electrode ([0148]), and Chen describes wherein the electrode is an ECG electrode ([0044]).
Regarding claim 18, Chen describes a plurality of the textile-based ECG generator electrodes and plurality of the textile-based ECG receiver electrodes ([0009], [0038]).
Regarding claim 19, Chen describes wherein the generated signal is generated using a given generator electrode of the plurality of textile-based ECG generator electrodes and the generated signal is sensed using a given receiver electrode of the plurality of textile-based ECG receiver electrodes ([0009], [0038]).
Regarding claim 20, Chen describes wherein the controller is configured to determine whether the generated signal generated using the given generator electrode and the generated signal sensed using the given receiver electrode does not satisfy a quality threshold, and selects an alternative generator electrode and/or an alternative receiver electrode ([0041] - [0042], [0044] - [0046], automatic electrode selection algorithm and electrode switching steps as described).
Regarding claim 21, Chen describes wherein the controller continues selecting alternative generator electrodes and/or alternative receiver electrodes to choose a generator electrode and receiver electrode pairing that satisfies a signal quality threshold ([0041] - [0042], [0044] - [0046], automatic electrode selection algorithm and electrode switching steps as described).
Regarding claim 22, Chahine describes wherein the garment includes a belt portion having at least one of the plurality of textile-based electrodes (figures 32-34, “band” configuration).
Regarding claim 23, Chahine describes wherein the interlaced conductive fibers are formed by weaving electrically conductive threads ([0097]).
Regarding claim 25, Chahine describes wherein the plurality of textile-based ECG electrodes are exposed on a first side and insulated on a second side ([0101]).
Regarding claim 26, Chahine describes wherein the interlaced conductive fibers are interlaced with non-conductive fibers of a body of the smart garment ([0108], [0110]).
Regarding claim 27, Chahine describes a conductive trace connected to the each of the plurality of textile-based electrodes, each of the conductive traces for connecting the plurality textile-based electrodes to the controller for sending and receiving one or more electronic signals using the plurality of textile-based electrodes ([0050]).
Regarding claim 28, Chen describes wherein the controller alternates different pairings chosen from the plurality of textile-based ECG electrodes as one or more selected pairs in order to determine a decided optimum signal from the one or more electronic signals received from the different pairings ([0042]).
Regarding claim 29, Chahine describes a smart garment for detecting physiological data of a user ([0020]), the smart garment comprising
a plurality of textile-based electrodes, wherein each of the plurality of textile-based electrodes comprises interlaced conductive fibers for conducting a plurality of signals with respect to a body of the user ([0050])
wherein the plurality of textile-based electrodes includes at least one textile-based generator electrode for transmitting a generated signal through the user’s skin and at least one textile-based receiver electrode spaced apart from the textile-based generator electrode for sensing the generated signal through the user’s skin ([0004], [0151]), wherein the textile-based generator electrode that generates the generated signal and the textile-based receiver electrode that senses the generated signal define a textile-based electrode pairing ([0026], [0028])
a controller device electronically coupled to the plurality of textile-based electrodes ([0004], [0026]), the controller device configured to
generate the generated signal ([0004], [0026])
transmit the generated signal through the at least one textile-based generator electrode ([0004], [0026])
sense the generated signal via one or more textile-based receiver electrodes ([0020])
Regarding claim 29, Chahine does not explicitly disclose wherein the textile-based electrodes are ECG electrodes, and Chahine does not explicitly disclose wherein the controller device is configured to
based on the sensing the generated signal, determine at least one of the plurality of textile-based ECG electrodes from the textile-based ECG electrode pairing (i) is at least partially out of contact with skin of the user and/or (ii) causes the generated signal that is transmitted through the at least one ECG generator electrode to be of unacceptable signal quality
deselect the at least one determined textile-based ECG electrode from the electrode pairing, and select another textile-based ECG electrode pairing
repeat said generate and said sense of the generated signal using the another textile-based ECG electrode pairing
However, Chen also describes a smart garment for detecting physiological data of a user ([0030] - [0031]), including a plurality of ECG electrodes ([0030]) and a controller device configured to
based on the sensing the generated signal, determine at least one of the plurality of textile-based ECG electrodes from the textile-based ECG electrode pairing is at least partially out of contact with the skin of the user and/or causes the generated signal that is transmitted through at least one ECG generator electrode to be of unacceptable signal quality ([0011], [0041])
deselect the at least one determined textile-based ECG electrode from the electrode pairing, and select another textile-based ECG electrode pairing ([0044] - [0045])
repeat said generate and said sense of the generated signal using the another textile-based ECG electrode pairing ([0045] - [0046])
As Chen is also directed towards detecting physiological data of a user and is in a similar field of endeavor, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to incorporate a signal quality detection component similar to that described by Chen when using the electrodes described by Chahine, as doing so advantageously ensures that the measured physiological data is of acceptable quality for further analysis.
Regarding claim 30, Chen describes wherein the controller device is configured to process the generated signal to analyze the physiological data to determine a defined health event of the user ([0003], diagnosing the physiological status and health of an individual).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Chahine in view of Chen, further in view of Kaib et al. (US 2011/0288605 A1).
Regarding claim 17, Chahine in view of Chen suggests the smart garment of claim 11, but neither Chahine nor Chen explicitly disclose wherein the controller determines a change in a desired location of one or more of the plurality of the textile-based ECG electrodes.  However, Kaib also describes a smart garment for detecting physiological data of a user ([0008]), including a controller configured to determine a change in a location of one or more of a plurality of textile-based electrodes ([0091], determining if the electrodes have shifted or moved to a slightly different location).  As Kaib is also directed towards detecting physiological data of a user and is in a similar field of endeavor, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to use Kaib’s feature of determining whether electrodes have changed locations when using the system described by Chahine and Chen, as doing so advantageously allows the resulting system to account for the electrode movements and select a different set of electrodes, if necessary, in order to obtain the highest quality ECG signal.
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Chahine in view of Chen, further in view of Rapin et al. (US 2019/0223739 A1).
Regarding claim 24, Chahine in view of Chen suggests the smart garment of claim 11, but neither Chahine nor Chen explicitly disclose wherein the controller uses physiological data sensed by the plurality of textile-based ECG electrodes to determine a quantity of the user selected from the group consisting of a PR interval, a QT interval, a corrected QT (QTc) interval, a PR axis, and a QRS axis.  However, Rapin also describes analyzing ECG data for monitoring a user’s health ([0002]), including using a controller to determine a PR interval, a QT interval, a corrected QT (QTc) interval, a PR axis, and/or a QRS axis of a user ([0020], [0060]).  As Rapin is also directed towards using ECG data for health analysis and is in a similar field of endeavor, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to use measures similar to those described by Rapin when analyzing the data generated by the textile-based ECG electrodes suggested by Chahine and Chen, as doing so advantageously allows the resulting system to better characterize a patient’s health status and suggest corrective action when necessary.
Statement on Communication via Internet
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Conclusion
Applicant’s amendment necessitated the new ground(s) of rejection presented in this Office action.  Accordingly, THIS ACTION IS MADE FINAL.  See MPEP § 706.07(a).  Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
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CITED REFERENCE SUMMARIES: Ref US20110288605A1: Claims:
An ambulatory medical device, comprising: a plurality of electrodes configured to be disposed at spaced apart positions about a body of a patient; an electrode signal acquisition circuit having a plurality of inputs, each respective input of the plurality of inputs being electrically coupled to a respective electrode of the plurality of electrodes, the electrode signal acquisition circuit being configured to sense a respective signal provided by a plurality of different pairings of the plurality of electrodes; and a monitoring circuit, electrically coupled to an output of the electrode signal acquisition circuit, the monitoring circuit being configured to analyze the respective signal provided by each of the plurality of different pairings and to instruct the electrode signal acquisition circuit to select at least one of the plurality of different pairings to monitor based upon at least one of a quality of the respective signal provided by the selected at least one of the plurality of different pairings, a phase difference between the respective signal provided by the selected at least one of the plurality of different pairings and the respective signal provided by another selected at least one of the plurality of different pairings, a position of the respective electrodes of the selected at least one of the plurality of different pairings relative to the body of the patient, a plane defined by the respective electrodes of the selected at least one of the plurality of different pairings, and a cardiac cycle of a heart of the patient.
a plurality of electrodes configured to be disposed at spaced apart positions about a body of a patient;
an electrode signal acquisition circuit having a plurality of inputs, each respective input of the plurality of inputs being electrically coupled to a respective electrode of the plurality of electrodes, the electrode signal acquisition circuit being configured to sense a respective signal provided by a plurality of different pairings of the plurality of electrodes; and
a monitoring circuit, electrically coupled to an output of the electrode signal acquisition circuit, the monitoring circuit being configured to analyze the respective signal provided by each of the plurality of different pairings and to instruct the electrode signal acquisition circuit to select at least one of the plurality of different pairings to monitor based upon at least one of a quality of the respective signal provided by the selected at least one of the plurality of different pairings, a phase difference between the respective signal provided by the selected at least one of the plurality of different pairings and the respective signal provided by another selected at least one of the plurality of different pairings, a position of the respective electrodes of the selected at least one of the plurality of different pairings relative to the body of the patient, a plane defined by the respective electrodes of the selected at least one of the plurality of different pairings, and a cardiac cycle of a heart of the patient.
The ambulatory medical device of claim 1 , further comprising a garment that is configured to be worn about the body of the patient, wherein the plurality of electrodes are integrated into the garment.
The ambulatory medical device of claim 2 , wherein the plurality of electrodes are ECG sensing electrodes, and wherein the monitoring circuit is a cardiac monitoring and arrhythmia detection circuit.
The ambulatory medical device of claim 3 , wherein the plurality of ECG sensing electrodes includes at least three ECG sensing electrodes.
The ambulatory medical device of claim 4 , wherein the plurality of ECG sensing electrodes are not all located in a common plane.
The ambulatory medical device of claim 5 , wherein the cardiac monitoring and arrhythmia detection circuit is configured to analyze the respective signal provided by each of the plurality of different pairings and to instruct the electrode signal acquisition circuit to select the at least one of the plurality of different pairings to monitor based upon the quality of the respective signal provided by the selected at least one of the plurality of different pairings and the phase difference between the respective signal provided by the selected at least one of the to plurality of different pairings and the respective signal provided by the other selected at least one of the plurality of different pairings.
The ambulatory medical device of claim 6 , further comprising: a plurality of therapy electrodes integrated into the garment and configured to deliver a defibrillating shock to the body of the patient in response to detection of a treatable cardiac arrhythmia by the cardiac monitoring and arrhythmia detection circuit.
a plurality of therapy electrodes integrated into the garment and configured to deliver a defibrillating shock to the body of the patient in response to detection of a treatable cardiac arrhythmia by the cardiac monitoring and arrhythmia detection circuit.
The ambulatory medical device of claim 5 , wherein the cardiac monitoring and arrhythmia detection circuit is configured to analyze the respective signal provided by each of the plurality of different pairings and to instruct the electrode signal acquisition circuit to select the at least one of the plurality of different pairings to monitor based upon the quality of the respective signal provided by the selected at least one of the plurality of different pairings and the plane defined by the respective electrodes of the selected at least one of the plurality of different pairings.
The ambulatory medical device of claim 5 , wherein the cardiac monitoring and arrhythmia detection circuit is configured to analyze the respective signal provided by each of the plurality of different pairings and to instruct the electrode signal acquisition circuit to select the at least one of the plurality of different pairings to monitor based upon the position of the respective electrodes of the selected at least one of the plurality of different pairings relative to the body of the patient and the cardiac cycle of the heart of the patient.
The ambulatory medical device of claim 5 , wherein the cardiac monitoring and arrhythmia detection circuit is configured to select at least three of the plurality of different pairings to monitor based upon the at least one of the quality of the respective signal provided by each of the selected at least three of the plurality of different pairings, the phase difference between the respective signal provided by each of the selected at least three of the plurality of different pairings, the position of the respective electrodes of the selected at three of the plurality of different pairings relative to the body of the patient, the plane defined by the respective electrodes of the selected at least three of the plurality of different pairings, and the cardiac cycle of the heart of the patient.
The ambulatory medical device of claim 1 , further comprising a garment that is configured to be worn about the body of the patient, wherein the plurality of electrodes are integrated into the garment, and wherein the plurality of electrodes includes at least four ECG sensing electrode that are not all located in a common plane.
The ambulatory medical device of claim 11 , wherein the monitoring circuit is configured to analyze the respective signal provided by each of the plurality of different pairings and to instruct the electrode signal acquisition circuit to select the at least one of the plurality different pairings to monitor based upon the quality of the respective signal provided by the selected at least one of the plurality of different pairings and the phase difference between the respective signal provided by the selected at least one of the plurality of different pairings and the respective signal provided by the other selected at least one of the plurality of different pairings.
The ambulatory medical device of claim 11 , wherein the monitoring circuit is configured to analyze the respective signal provided by each of the plurality of different pairings and to instruct the electrode signal acquisition circuit to select the at least one of the plurality of different pairings to monitor based upon the quality of the respective signal provided by the selected at least one of the plurality of different pairings and the plane defined by the respective electrodes of the selected at least one of the plurality of different pairings.
The ambulatory medical device of claim 11 , wherein the monitoring circuit is configured to analyze the respective signal provided by each of the plurality of different pairings and to instruct the electrode signal acquisition circuit to select the at least one of the plurality of different pairings to monitor based upon the position of the respective electrodes of the selected at least one of the plurality of different pairings relative to the body of the patient and the cardiac cycle of the heart of the patient.
The ambulatory medical device of claim 11 , wherein the monitoring circuit is configured to select at least three of the plurality of different pairings to monitor based upon the at least one of the quality of the respective signal provided by each of the selected at least three of the plurality of different pairings, the phase difference between the respective signal to provided by each of the selected at least three of the plurality of different pairings, the position of the respective electrodes of the selected at three of the plurality of different pairings relative to the body of the patient, the plane defined by the respective electrodes of the selected at least three of the plurality of different pairings, and the cardiac cycle of the heart of the patient.
The ambulatory medical device of claim 15 , wherein the monitoring circuit is configured to select at least two of the selected at least three of the plurality of different pairings to monitor during a first time interval and to select a different at least two of the selected at least three of the plurality of different pairings to monitor during a second time interval.
The ambulatory medical device of claim 1 , wherein the plurality of electrodes are ECG sensing electrodes, and wherein the monitoring circuit is a cardiac monitoring and arrhythmia detection circuit.
The ambulatory medical device of claim 17 , wherein the plurality of ECG sensing electrodes includes at least three ECG sensing electrodes.
The ambulatory medical device of claim 1 , wherein the monitoring circuit is configured to analyze the respective signal provided by each of the plurality of different pairings and to instruct the electrode signal acquisition circuit to select the at least one of the plurality different pairings to monitor based upon the quality of the respective signal provided by the selected at least one of the plurality of different pairings and the phase difference between the respective signal provided by the selected at least one of the plurality of different pairings and the respective signal provided by the other selected at least one of the plurality of different pairings.
The ambulatory medical device of claim 1 , wherein the monitoring circuit is configured to analyze the respective signal provided by each of the plurality of different pairings and to instruct the electrode signal acquisition circuit to select the at least one of the plurality of different pairings to monitor based upon the quality of the respective signal provided by the selected at least one of the plurality of different pairings and the plane defined by the respective electrodes of the selected at least one of the plurality of different pairings.
The ambulatory medical device of claim 1 , wherein the monitoring circuit is configured to analyze the respective signal provided by each of the plurality of different pairings and to instruct the electrode signal acquisition circuit to select the at least one of the plurality of different pairings to monitor based upon the position of the respective electrodes of the selected at least one of the plurality of different pairings relative to the body of the patient and the cardiac cycle of the heart of the patient.
The ambulatory medical device of claim 1 , wherein the electrode signal acquisition circuit includes: a selection circuit having a plurality of inputs and a plurality of outputs, each respective input of the plurality of inputs of the selection circuit being electrically coupled to a respective one of the plurality of electrodes; and a plurality of differential amplifiers, each respective differential amplifier having a pair of inputs and an output, each respective input of the pair of inputs being electrically coupled to a respective one of the plurality of outputs of the selection circuit, each respective output of the plurality of differential amplifiers providing an output signal corresponding to a difference between the pair of inputs of the respective differential amplifier.
a selection circuit having a plurality of inputs and a plurality of outputs, each respective input of the plurality of inputs of the selection circuit being electrically coupled to a respective one of the plurality of electrodes; and
a plurality of differential amplifiers, each respective differential amplifier having a pair of inputs and an output, each respective input of the pair of inputs being electrically coupled to a respective one of the plurality of outputs of the selection circuit, each respective output of the plurality of differential amplifiers providing an output signal corresponding to a difference between the pair of inputs of the respective differential amplifier.
The ambulatory medical device of claim 1 , wherein the electrode signal acquisition circuit includes: a plurality of differential amplifiers each having a pair of inputs and an output, the plurality of differential amplifiers including a respective differential amplifier for each unique pairing of the plurality of electrodes; and a selection circuit configured to select at least one output of the plurality of differential amplifiers to provide to the monitoring circuit.
a plurality of differential amplifiers each having a pair of inputs and an output, the plurality of differential amplifiers including a respective differential amplifier for each unique pairing of the plurality of electrodes; and
a selection circuit configured to select at least one output of the plurality of differential amplifiers to provide to the monitoring circuit.
The ambulatory medical device of claim 1 , wherein the electrode signal acquisition circuit includes: an analog multiplexor having a plurality of inputs and an output, each of the plurality of inputs being electrically coupled to a respective one of the plurality of electrodes; and an analog-to-digital converter having an input electrically coupled to the output of the analog multiplexer.
an analog multiplexor having a plurality of inputs and an output, each of the plurality of inputs being electrically coupled to a respective one of the plurality of electrodes; and
an analog-to-digital converter having an input electrically coupled to the output of the analog multiplexer.
The ambulatory medical device of claim 24 , wherein the analog-to digital converter has a sampling rate that is at least N times a desired sampling rate of a signal provided by each of the plurality of electrodes, where N is the number of the plurality of electrodes that are to be monitored.
The ambulatory medical device of claim 24 , wherein the monitoring circuit includes at least one processor configured to receive a first digital signal corresponding to a first electrode of the plurality of electrodes and a second digital signal corresponding to a second electrode of the plurality of electrodes, to invert one of the first and second digital signals and sum the inverted one of the first and second digital signals with the other of the first and second digital signals to analyze the respective signal provided by a pairing of the first electrode and the second electrode.
The ambulatory medical device of claim 1 , wherein the electrode signal acquisition circuit includes a plurality of analog-to-digital converters, each respective analog-to-digital converter having a respective input that is electrically coupled to a respective one of the plurality of electrodes.
The ambulatory medical device of claim 27 , wherein each of the plurality of analog-to-digital converters is connected to another of the plurality of analog-to-digital converters by a serial bus.
A method of monitoring ECG signals, the method comprising acts of: selecting, from among a plurality of ECG sensors, a plurality of different pairings of ECG sensors; analyzing a respective ECG signal provided by each of the plurality of different pairings; identifying at least one of the plurality of different pairings to monitor based upon at least one of a quality of the respective ECG signal provided by the identified at least one of the plurality of different pairings, a phase difference between the respective ECG signal provided by the identified at least one of the plurality of different pairings and the respective ECG signal provided by another identified at least one of the plurality of different pairings, a position of to respective ECG sensors of the identified at least one of the plurality of different pairings relative to a body of a patient, a plane defined by the respective ECG sensors of the identified at least one of the plurality of different pairings, and a cardiac cycle of a heart of the patient; and monitoring the identified at least one of the plurality of different pairings.
selecting, from among a plurality of ECG sensors, a plurality of different pairings of ECG sensors;
analyzing a respective ECG signal provided by each of the plurality of different pairings;
identifying at least one of the plurality of different pairings to monitor based upon at least one of a quality of the respective ECG signal provided by the identified at least one of the plurality of different pairings, a phase difference between the respective ECG signal provided by the identified at least one of the plurality of different pairings and the respective ECG signal provided by another identified at least one of the plurality of different pairings, a position of to respective ECG sensors of the identified at least one of the plurality of different pairings relative to a body of a patient, a plane defined by the respective ECG sensors of the identified at least one of the plurality of different pairings, and a cardiac cycle of a heart of the patient; and
monitoring the identified at least one of the plurality of different pairings.
The method of claim 29 , wherein the act of identifying at least one of the plurality of different pairings to monitor is based upon the quality of the respective ECG signal provided by the identified at least one of the plurality of different pairings and the phase difference between the respective ECG signal provided by the identified at least one of the plurality of different pairings and the respective ECG signal provided by the other identified at least one of the plurality of different pairings.
The method of claim 30 , wherein the act of selecting the plurality of different pairings of ECG sensors from among the plurality of ECG sensors includes an act of selecting, from among the plurality of ECG sensors, each unique pairing of ECG sensors; and wherein the act of analyzing the respective ECG signal provided by each of the plurality of different pairings includes analyzing the respective ECG signal provided by each unique pairing of ECG sensors.
The method of claim 31 , wherein the act of monitoring includes: monitoring the identified at least one of the plurality of different pairings to 
[Truncated to input limit]