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 .
Continued Examination Under 37 CFR 1.114
Receipt is acknowledged of a request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e) and a submission, filed on 05/08/2026.
Response to Amendment
Examiner acknowledges that no new claim amendments have been entered with claims 4, 13 and 18 cancelled in prosecution. Currently claims 1-3,5-12,14-17 and 19-20 are pending in prosecution.
Claim Rejections - 35 USC § 103
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 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.
Claim(s) 1-3,5-12,14-17 and 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ghaffari (US Patent No 9226678) in view of Dattaram (WIPO publication 2019150398) further in view of Parale (US Patent No 20220369983) further in view of Ward (US Patent No 20170067976). Examiner acknowledges that Parale was published after the filing date of the present application, however Parale has claims to a priority date of 10/05/2020 which is prior to the filing date of the present application and is therefore eligible prior art of record to be used in prosecution.
Regarding claim 1, Ghaffari teaches an apparatus comprising: a housing cable (cable 210, [35]) comprising a plurality of signal cables therein (cable 210 may include a plurality of signal conductors, [35]); four or more electrodes along the housing cable, each of the four or more electrodes to conductively (see fig. 3 which shows the four or more mating devices 320-328 located along the length of the cable 210 which each connect to respective electrodes).
Ghaffari does not explicitly teach to contact a particular location of a user by a direct contact between the each of the four or more electrodes and the particular location of the user. Ghaffari does teach mating devices 320-328 located along the length of the cable 210 which each connect to respective electrodes but does not explicitly teach the electrodes directly contacting the target location of the user as claimed.
However, having ECG signal electrodes directly attached to the target location is well known in the art, and would have therefore been obvious to use in combination with the signal cable apparatus of Ghaffari. For example, see the analogous ECG signal cable and patch system of Dattaram which discloses leads 10 with electrodes V1-V6 which are found in continuous and direct contact with the user’s skin, seen in the description and fig 2E.
Therefore, it would have been obvious for one skilled in the art prior to the effective filing date to combine the housing cable apparatus of Ghaffari with the specific direct electrode placement taught by Dattaram in order to allow for more flexibility in apparatus attachment as well as maximizing noise reduction of connecting components as disclosed by Dattaram.
Ghaffari and Dattaram do not explicitly teach a computing device positioned along the housing cable and operatively coupled to each of the four or more electrodes via a respective signal cable of the plurality of signal cables, the computing device comprising: a memory; and a processing device operatively coupled to the memory, the processing device to: perform, using the four or more electrodes, an electrocardiogram (ECG) of the user.
However, the analogous system and method for remote ECG monitoring taught by Parale does disclose a computing device positioned along the housing cable and operatively coupled to each of the four or more electrodes via a respective signal cable of the plurality of signal cables (the signal processing unit which connects to the respective signal cables is adapted with a computing device which generates and reads the 12-lead ECG signals, [0016]), the computing device comprising: a memory; and a processing device operatively coupled to the memory (the computing or communication device 80 comprises components of at least one memory and at least one processor, [0094]), the processing device to: perform, using the four or more electrodes, an electrocardiogram (ECG) of the user (the processing unit to receive and generate the 12-lead ECG theorem signals, [0094]).
Therefore, it would have been obvious for one skilled in the art prior to the effective filing date to combine the structure of the ECG cable taught by Ghaffari with the processing unit disclosed by Parale in order to effectively automate and control the ECG system for easier and better ECG signals, as disclosed by Parale, [0094].
Furthermore, none of the previous prior art of record go on to teach that the electrodes conductively contact an upper right limb, an upper left limb, a lower left limb, and a chest position as well as each of the four or more electrodes and respectively in having a direct electrical connection to a respective signal cable of the plurality of signal cables.
However, having the electrodes conductively contact an upper right limb, an upper left limb, a lower left limb, and a chest position as well as the four or more electrodes in direct electrical connection to each of the plurality of signal cables is obvious and well known to one of skill in the art. For example, see the analogous 12-lead ECG cable taught by Ward in which it is stated that the system contains a plurality of signal leads in which the plurality of signal leads is electrically coupled to all of the respective individual signal electrodes placed on the respective parts of the body on the patient, as seen in claim 1 and figure 1. Thereby effectively teaching that each electrode is in direct electrical contact to each of the plurality of signal cables as claimed. Furthermore, Ward discloses that the electrodes of the device contact a right arm, left arm, left leg, right leg as well as several electrodes conductively placed along the chest region, [0015].
Therefore, it would have been obvious for one skilled in the art prior to the effective filing date to combine the previously taught ECG signal combination with that of the 12-lead individual electrode connections and anatomical placements taught by Ward, in order to more efficiently send and compute ECG signals and shield each respective electrode from the other, as disclosed by Ward, [abstract].
Regarding claim 2, the combination teaches the apparatus of claim 1, wherein to perform an ECG of the user, the processing device is to: measure a signal generated by each of the four or more electrodes when the housing cable is connected to the user; and calculate ECG data comprising a set of leads of the ECG based on the signal generated by each of the four or more electrodes (from Parale, the second component is a signal processing unit (20) operably/operatively and electrically coupled (i.e. physically) to the first component (i.e. the electrode sensor assembly (10) which is coupled via the four or more electrodes to the body) for receiving the 12-lead ECG signals (raw signals) and generating the 12-lead ECG (processed signals) therefrom, [0078]).
Regarding claim 3, the combination teaches the apparatus of claim 2, wherein the computing device further comprises: a transceiver to transmit the ECG data to a computing device (from Parale, the cable interface also contains a wireless transceiver which the 12-lead ECG signals are transmitted to the computing unit 80, [0078]).
Regarding claim 5, the combination teaches the apparatus of claim 1, wherein each of the four or more electrodes are dry electrodes (from Parale, wherein the electrode sensors are preferably dry electrode sensors, [0087]).
Regarding claim 6, the combination teaches the apparatus of claim 5, wherein each of the four or more electrodes comprises a coupling mechanism to secure the electrode to a corresponding respective location of the user (from Ghaffari, the electrodes are electrode pads placed and the conventional places of the user, in which they are mated using the mating devices 320-328, [38], which is the same as coupling to the body).
Regarding claim 7, the combination teaches the apparatus of claim 1, wherein each of the four or more electrodes comprises an adhesive material to connect the electrode to a corresponding respective location of the user (from Ghaffari, the leads 110 are connected to the electrode pads which are adhesively applied to the skin, [31]).
Regarding claim 8, Ghaffari teaches an apparatus comprising: a housing cable (cable 210, [35]) comprising a plurality of signal cables therein (cable 210 may include a plurality of signal conductors, [35]); four or more electrodes along the housing cable to maintain conductive contact with a particular location of a user (see fig. 3 which shows the four or more mating devices 320-328 located along the length of the cable 210 which each connect to respective electrodes) without any muscular activity of the user when the four or more electrodes are connected to the user (electrode pads may require no movement for an EKG test, [42])
Ghaffari does not explicitly teach to contact a particular location of a user by a direct contact between the each of the four or more electrodes and the particular location of the user when the four or more electrodes are connected to the user. Ghaffari does teach mating devices 320-328 located along the length of the cable 210 which each connect to respective electrodes but does not explicitly teach the electrodes directly contacting the target location of the user as claimed.
However, having ECG signal electrodes directly attached to the target location is well known in the art, and would have therefore been obvious to use in combination with the signal cable apparatus of Ghaffari. For example, see the analogous ECG signal cable and patch system of Dattaram which discloses leads 10 with electrodes V1-V6 which are found in continuous and direct contact with the user’s skin, seen in the description and fig 2E.
Therefore, it would have been obvious for one skilled in the art prior to the effective filing date to combine the housing cable apparatus of Ghaffari with the specific direct electrode placement taught by Dattaram in order to allow for more flexibility in apparatus attachment as well as maximizing noise reduction of connecting components as disclosed by Dattaram.
Ghaffari and Dattaram does not teach a computing device positioned along the housing cable and operatively coupled to each of the four or more electrodes via a respective signal cable of the plurality of signal cables, the computing device comprising: a memory; and a processing device operatively coupled to the memory, the processing device to: perform, using the four or more electrodes, an electrocardiogram (ECG) of the user.
However, the analogous system and method for remote ECG monitoring taught by Parale does disclose a computing device positioned along the housing cable and operatively coupled to each of the four or more electrodes via a respective signal cable of the plurality of signal cables (the signal processing unit which connects to the respective signal cables is adapted with a computing device which generates and reads the 12-lead ECG signals, [0016]), the computing device comprising: a memory; and a processing device operatively coupled to the memory (the computing or communication device 80 comprises components of at least one memory and at least one processor, [0094]), the processing device to: perform, using the four or more electrodes, an electrocardiogram (ECG) of the user (the processing unit to receive and generate the 12-lead ECG theorem signals, [0094]).
Therefore, it would have been obvious for one skilled in the art prior to the effective filing date to combine the structure of the ECG cable taught by Ghaffari with the electrode placement and processing unit disclosed by Parale in order to effectively automate and control the ECG system for easier and better ECG signals, as disclosed by Parale, [0094].
Furthermore, none of the previous prior art of record go on to teach that the electrodes conductively contact an upper right limb, an upper left limb, a lower left limb, and a chest position as well as each of the four or more electrodes and respectively in having a direct electrical connection to a respective signal cable of the plurality of signal cables.
However, having the four or more electrodes in direct electrical connection to each of the plurality of signal cables is obvious and well known to one of skill in the art. For example, see the analogous 12-lead ECG cable taught by Ward in which it is stated that the system contains a plurality of signal leads in which the plurality of signal leads is electrically coupled to all of the respective individual signal electrodes placed on the respective parts of the body on the patient, as seen in claim 1 and figure 1. Thereby effectively teaching that each electrode is in direct electrical contact to each of the plurality of signal cables as claimed. Furthermore, Ward discloses that the electrodes of the device contact a right arm, left arm, left leg, right leg as well as several electrodes conductively placed along the chest region, [0015].
Therefore, it would have been obvious for one skilled in the art prior to the effective filing date to combine the previously taught ECG signal combination with that of the 12-lead individual electrode connections taught by Ward, in order to more efficiently send and compute ECG signals and shield each respective electrode from the other, as disclosed by Ward, [abstract].
Regarding claim 9, the combination teaches the apparatus of claim 8, wherein the housing cable comprises an elastic material (from Parale, the unit is made from an elastic/elastomeric material known in the art for flexibility features, [0084]).
Regarding claim 10, the combination teaches the apparatus of claim 9, wherein the plurality of signal cables comprises one or more flexible printed circuits (from Ghaffari, the cable 210 which includes a plurality of conductors are formed through printed circuit conductive traces, [54]).
Regarding claim 11, the combination teaches the apparatus of claim 8, wherein each of the four or more electrodes comprises a coupling mechanism to secure the direct contact between the each of the four or more electrodes and the particular location of the user (from Ghaffari, the electrodes are electrode pads placed and the conventional places of the user, in which they are mated using the mating devices 320-328, [38], which is the same as coupling to the body).
Regarding claim 12, the combination teaches the apparatus of claim 11, wherein the coupling mechanism comprise one of: a clamp, a suction cup, a band, or a cuff brace (from Ghaffari, the mating devices may be any form of mating device capable of holding the cable to the electrode without departing the scope of the invention, [38], furthermore see fig 3 which depicts the mating devices as a clamp).
Although Ghaffari does not explicitly state the coupling device to include a clamp, a suction cup, a band, and a cuff brace, it does say that any mating device can be used as long as it maintains the scope of the disclosure. Therefore, it would be obvious for one of reasonably apprised skill in the art to choose the mating device to be a clamp, a suction cup, a band, and a cuff brace.
Regarding claim 14, the combination teaches the apparatus of claim 8, wherein the four or more electrodes are dry electrodes (from Parale, wherein the electrode sensors are preferably dry electrode sensors, [0087]).
Regarding claim 15, Ghaffari teaches a system comprising: an apparatus comprising: a housing cable (cable 210, [35]) comprising a plurality of signal cables therein (cable 210 may include a plurality of signal conductors, [35]); four or more electrodes along the housing cable and respectively in electrical connection to the plurality of signal cables, each of the four or more electrodes to conductively contact a particular location (see fig. 3 which shows the four or more mating devices 320-328 located along the length of the cable 210 which each connect to respective electrodes).
Ghaffari does not explicitly teach to contact a particular location of a user by a direct contact between the each of the four or more electrodes and the particular location of the user when the four or more electrodes are connected to the user. Ghaffari does teach mating devices 320-328 located along the length of the cable 210 which each connect to respective electrodes but does not explicitly teach the electrodes directly contacting the target location of the user as claimed.
However, having ECG signal electrodes directly attached to the target location is well known in the art, and would have therefore been obvious to use in combination with the signal cable apparatus of Ghaffari. For example, see the analogous ECG signal cable and patch system of Dattaram which discloses leads 10 with electrodes V1-V6 which are found in continuous and direct contact with the user’s skin, seen in the description and fig 2E.
Therefore, it would have been obvious for one skilled in the art prior to the effective filing date to combine the housing cable apparatus of Ghaffari with the specific direct electrode placement taught by Dattaram in order to allow for more flexibility in apparatus attachment as well as maximizing noise reduction of connecting components as disclosed by Dattaram.
Ghaffari does not teach a first computing device positioned along the housing cable and operatively coupled to each of the four or more electrodes via a respective signal cable, the computing device comprising: a memory; and a processing device operatively coupled to the memory, the processing device to: measure a signal generated by each of the four or more electrodes; determine first ECG data of the user based on the signal generated by each of the four or more electrodes, the first ECG data corresponding to leads measured by the processing device; and transmit the first ECG data; and a second computing device to: receive the first ECG data; and synthesize second ECG data of the user based on the first ECG data, the second ECG data corresponding to leads that were not measured by the processing device.
However, the analogous system and method for remote ECG monitoring taught by Parale does disclose a first computing device positioned along the housing cable and operatively coupled to each of the four or more electrodes via a respective signal cable (the signal processing unit which connects to the respective signal cables is adapted with a computing device which generates and reads the 12-lead ECG signals from the four respective electrodes, [0016]), the computing device comprising: a memory; and a processing device operatively coupled to the memory (the computing or communication device 80 comprises components of at least one memory and at least one processor, [0094]), the processing device to: measure a signal generated by each of the four or more electrodes; determine first ECG data of the user based on the signal generated by each of the four or more electrodes, the first ECG data corresponding to leads measured by the processing device (the processing unit to receive and generate the 12-lead ECG theorem signals, from the leads on the four respective electrodes [0094]); and transmit the first ECG data (wireless transceiver which the 12-lead ECG signals are transmitted to the computing unit 80, [0078]); and a second computing device (the ECG signal acquisition unit 40, [0060]) to: receive the first ECG data; and synthesize second ECG data of the user based on the first ECG data (in which the ECG acquisition unit goes through post processing and signal transformation to generate the second ECG of the user, [0060]), the second ECG data corresponding to leads that were not measured by the processing device (this information was generated and transformed from a post processing unit and therefore not measured by the processing device, [0060]).
Therefore, it would have been obvious for one skilled in the art prior to the effective filing date to combine the structure of the ECG cable taught by Ghaffari with the electrode placement and processing unit disclosed by Parale in order to effectively automate and control the ECG system for easier and better ECG signals, as disclosed by Parale, [0094].
Furthermore, none of the previous prior art of record go on to teach that the electrodes conductively contact an upper right limb, an upper left limb, a lower left limb, and a chest position as well as each of the four or more electrodes and respectively in having a direct electrical connection to a respective signal cable of the plurality of signal cables.
However, having the four or more electrodes in direct electrical connection to each of the plurality of signal cables is obvious and well known to one of skill in the art. For example, see the analogous 12-lead ECG cable taught by Ward in which it is stated that the system contains a plurality of signal leads in which the plurality of signal leads is electrically coupled to all of the respective individual signal electrodes placed on the respective parts of the body on the patient, as seen in claim 1 and figure 1. Thereby effectively teaching that each electrode is in direct electrical contact to each of the plurality of signal cables as claimed. Furthermore, Ward discloses that the electrodes of the device contact a right arm, left arm, left leg, right leg as well as several electrodes conductively placed along the chest region, [0015].
Therefore, it would have been obvious for one skilled in the art prior to the effective filing date to combine the previously taught ECG signal combination with that of the 12-lead individual electrode connections taught by Ward, in order to more efficiently send and compute ECG signals and shield each respective electrode from the other, as disclosed by Ward, [abstract].
Regarding claim 16, the combination teaches the system of claim 15, wherein the second computing device is further to: determine one or more interpretations based on the first and second ECG data (wherein the ECG acquisition unit 40 goes through generated post processing of the raw ECG signal in order to present the human-readable data in an ideal format, [0060], therefore through the postprocessing the ECG acquisition unit 40 must go through signal interpretations to display the correct processed ECG data between the first raw ECG and the second processed ECG).
Regarding claim 17, the combination teaches the system of claim 16, further comprising: a mobile computing device (from Parale, communication device 80, claim 1) to: provide instructions to the user for connecting the apparatus to themselves such that each of the four or more electrodes is contacting the respective location of the user (from Parale, communication device (80) for establishing the communication network (60) therebetween and therewithin to enable effective real-time monitoring and management of the cardiovascular health of the user by the healthcare provider, wherein, instruction for adherence of the four limb electrode sensors (RA, LA, RL, LL) and said positions on the chest is provided, claim 1).
Regarding claim 19, the combination teaches the system of claim 15, wherein the four or more electrodes are dry electrodes (from Parale, wherein the electrode sensors are preferably dry electrode sensors, [0087]).
Regarding claim 20, the combination teaches the system of claim 15, wherein the four or more electrodes comprise an adhesive material to maintain contact between the electrode and the respective location of the user (from Ghaffari, the leads 110 are connected to the electrode pads which are adhesively applied to the skin, [31]).
Response to Arguments
Applicant’s arguments, see remarks, filed 05/08/2026, with respect to the rejection(s) of claim(s) 1, 8 and 15 under the prior art of Parale have been fully considered and are persuasive as agreed upon in the examiner interview. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of the newly considered prior art of Ward.
The examiner agrees with the applicant that the prior art or Parale in its exact structure does not teach the placement of the electrodes in the claimed sections of the upper right, upper left, lower left limbs and the chest. Therefore, the prior art of Parale has been withdrawn from that limitation rejection. However, upon further consideration it has been found that the analogous prior art of Ward suggests and discloses the limitation of and ECG cable which the electrodes of the device contact a right arm, left arm, left leg, right leg as well as several electrodes conductively placed along the chest region, [0015]. Therefore, as the prior art of Ward teaches the previous deficiencies of the prior art of Parale, the independent claims 1, 8 and 15 remains rejected under the prior art of record rejection of Ghaffari in view of Dattaram further in view of Parale further in view of the newly considered prior art of Ward set forth in the present office action.
Furthermore, regarding the argument that the prior art of Parale does not teach “a computing device positioned along the housing cable and operatively coupled to each of the four electrodes,” has been considered but ultimately falls unpersuasive. The examiner would like to reemphasize the disclosure brought forth in the previous office action and the present office action in which Parale teaches at the bottom of the specification paragraph [0016] that the signal processing unit which connects to the respective signal cables is adapted with a computing device which generates and reads the 12-lead ECG signals from the four respective electrodes. Furthermore, as stated in the specification paragraph [0016] the first component is in electrical communication or electrical connection with the second component. The first component being the electrode sensor assembly, and the second component being the signal processing unit adapted with a computing device. Therefore, as the electrode assembly is in communication and connection with the processing unit, the computing device is operatively coupled to the signal cables under the broadest reasonable interpretation of the claim language. Therefore, as the claim is interpreted under the broadest reasonable interpretation, the prior art of Parale reasonably discloses a computing device which is positioned in line with the housing cable via the respective signal cables. Therefore, as the claimed computing device is reasonably taught by Parale, the independent claims 1, 8 and 15 remain rejected under the prior art of record rejection of Ghaffari in view of Dattaram further in view of Parale set forth in the present office action.
As no further arguments or remarks were made in regards to any of the dependent claims, all dependents also remain rejected under the new prior art of record rejection set forth in the present office action.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYLE M BROWN whose telephone number is (703)756-4534. The examiner can normally be reached 8:00-5:00pm EST, Mon-Fri, alternating Fridays off.
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/KYLE M. BROWN/Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
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