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
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/30/2025 has been entered.
Response to Amendment
3. This action is responsive to the amendments filed 12/30/2025. Claims 1 and 15 have been amended. No claims were canceled or newly added.
Response to Arguments
Applicant’s response with respect to art rejections have been considered but are 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.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 1-8,15, and 17-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 (and similarly claim 15) recite the limitations of “synthesize a second set of ECG waveforms of the user based on the first set of ECG waveforms, the second set of ECG waveforms corresponding to all leads not formed by the first set of electrodes and the second set of electrodes together”. The claim limitations are indefinite and the scope of the claims is unclear. At the onset, the claims do not introduce the term “all leads”. Furthermore, the claims do not state a third set of electrodes from which additional leads can be derived from. For the purposes of examination, the limitation will be interpreted as all leads that are formed by the first set of electrodes alone as well as all leads formed by the second set of electrodes alone or leads formed by a separate set of electrodes. Although it should be noted that the technical definition of sets can include an empty set and thus would still fall within the combination of “the first set of electrodes and the second set of electrodes together”.
7. Claims 2-8 and 17-20 are rejected at least because they depend from a claim(s) which is indefinite.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-7, 9-13, 15, and 17-20 are rejected under 35 U.S.C 103 as being unpatentable over Kranz et al. (US Pub.: 2024/0197229 A1, – Previously Cited) and further in view of Albert et al. (International Publication No.: WO 2015/035251 A1, – Previously Cited) and further in view of Schreck et al. (US Pub.: 2017/0188861 A1).
Regarding claim 1, Kranz teaches an apparatus comprising:
a first housing (e.g. Fig. 8 – housing of element 448) comprising:
a first set of electrodes to contact a first location and second location of a user (e.g. Fig. 8 – electrodes 449 and 450);
and a cable (e.g. Fig. 8 – element 1032);
and a second housing (e.g. Fig. 8 – element 445 multi-channel base), the second housing operatively coupled to the first housing via the cable (e.g. Fig. 8 – element 1032),
the second housing (e.g. Fig. 8 – element 445 multi-channel base) further comprising:
a second set of electrodes to contact a third location and a fourth location of the user (e.g. Fig. 8 – electrodes 446 and 447);
a memory (e.g. paragraphs 0027, 0119);
and a processing device operatively coupled to the second set of electrodes and the memory (e.g. paragraphs 0027, 0119), the processing device configured to:
measure, using the first and second set of electrodes, a first set of electrocardiogram (ECG) waveforms of the user (e.g. paragraph 0119), the first set of ECG waveforms corresponding to leads formed by the first and second set of electrodes (e.g. paragraph 0119).
However, Kranz does not explicitly teach the second housing having a circular shape and the second housing comprising a socket in which the cable is removably attached as well as synthesize a second set of ECG waveforms of the user based on the first set of ECG waveforms, the second set of ECG waveforms corresponding to all leads not formed by the first set of electrodes and the second set of electrodes together.
Kranz, in another embodiment, discloses a socket in which the cable is removably attached (e.g. Fig. 44 – pin connector 779 and socket connector 780).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kranz to include a socket in which the cable is removably attached, as taught and suggested by another embodiment of Kranz, in order to provide the predictable results of allowing the use of interchangeable different type of electrode arrays as well as allowing for the cables to be changed/replaced when necessary.
However, the modified Kranz reference still does not explicitly teach the second housing having a circular shape as well as synthesize a second set of ECG waveforms of the user based on the first set of ECG waveforms, the second set of ECG waveforms corresponding to all leads not formed by the first set of electrodes and the second set of electrodes together.
Albert, in a same field of endeavor of electrocardiogram devices, discloses a housing having a circular shape (e.g. paragraph 00019).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kranz to incorporate a circular shape for the housing, as taught and suggested by Albert, because it is a simple substitution of one known shape for a housing for another in order to obtain the predictable results of effective electrocardiogram monitoring.
However, Kranz in view of Albert does not explicitly teach synthesizing a second set of ECG waveforms of the user based on the first set of ECG waveforms, the second set of ECG waveforms corresponding to all leads not formed by the first set of electrodes and the second set of electrodes together.
Schreck, in a same field of endeavor of electrocardiogram devices, discloses synthesizing a second set of ECG waveforms of the user based on the first set of ECG waveforms, the second set of ECG waveforms corresponding to all leads not formed by the first set of electrodes and the second set of electrodes together (e.g. paragraphs 056-0058, – using leads I, aVF, and V2 to derive/synthesize additional leads (i.e. leads III, aVR, V3, etc.)).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Kranz and Albert to incorporate synthesizing a second set of ECG waveforms of the user based on the first set of ECG waveforms, the second set of ECG waveforms corresponding to all leads not formed by the first set of electrodes and the second set of electrodes together, as taught and suggested by Schreck, for the purpose of obtaining additional electrical viewpoints of the heart so that a clinician can provide a more accurate diagnosis to a patient.
Regarding claim 2, Kranz in view of Albert in view of Schreck teaches the apparatus of claim 1 as discussed above, and Kranz further teaches wherein:
one or more of the first set of electrodes are positioned on a top side of the first housing to contact the first location of the user (e.g. Fig. 8 – electrode 449)
and one or more of the first set of electrodes are positioned on a bottom side of the first housing to contact the second location of the user (e.g. Fig. 8 – electrode 450);
and one or more of the second set of electrodes are positioned on a top side of the second housing to contact the third location of the user (e.g. Fig. 8 – element 446)
and one or more of the second set of electrodes are positioned on a bottom side of the second housing to contact the fourth location of the user (e.g. Fig. 8 – element 447).
Regarding claim 3, Kranz in view of Albert in view of Schreck teaches the apparatus of claim 1 as discussed above, and Kranz further teaches wherein the processing device is further configured to: determine one or more diagnoses based on the first and second set of ECG waveforms (e.g. paragraphs 0132, 0183).
Regarding claim 4, Kranz in view of Albert in view of Schreck teaches the apparatus of claim 3 as discussed above, and Kranz further teaches wherein the second housing further comprises: a transceiver to transmit the one or more diagnoses to a computing device (e.g. paragraph 0126).
Regarding claim 5, Kranz in view of Albert in view of Schreck teaches the apparatus of claim 1 as discussed above, and Kranz further teaches wherein the one or more of the first set of electrodes positioned on the top side of the first housing comprises a single electrode to contact the first location of the user (e.g. Fig. 8 – electrode 449; paragraph 0119), wherein the first location of the user corresponds to a left arm of the user (e.g. Fig. 8 – electrode 449; paragraph 0119, – additionally this limitation contains functional language (see MPEP 2114) and is the intended use of the device. The device of the prior art is interpreted to be fully capable of performing this function and therefore meets the scope of the limitation).
Regarding claim 6, Kranz in view of Albert in view of Schreck teaches the apparatus of claim 1 as discussed above, and Kranz further teaches wherein the one or more of the first set of electrodes positioned on the top side of the first housing comprises a first electrode and a second electrode positioned on the top side of the first housing to contact the first location of the user (e.g. paragraph 0119), wherein the first location of the user corresponds to a left arm of the user (e.g. paragraph 0119 – additionally this limitation contains functional language (see MPEP 2114) and is the intended use of the device. The device of the prior art is interpreted to be fully capable of performing this function and therefore meets the scope of the limitation).
Regarding claim 7, Kranz in view of Albert in view Schreck teaches the apparatus of claim 1 as discussed above, and Kranz further teaches wherein the first, second, third, and fourth locations of the user correspond to a right arm, chest, left arm, and left leg of the user respectively (e.g. paragraph 0119 – additionally this limitation contains functional language (see MPEP 2114) and is the intended use of the device. The device of the prior art is interpreted to be fully capable of performing this function and therefore meets the scope of the limitation).
Regarding claim 9, Kranz teaches an apparatus comprising:
a housing (e.g. Fig. 8 – element 445 multi-channel base), the housing comprising:
a set of electrodes to contact two or more locations of a user (e.g. Fig. 8 – electrodes 446 and 447);
a cable (e.g. Fig. 8 – element 1032);
a memory (e.g. paragraphs 0027, 0119);
and a processing device operatively coupled to the set of electrodes, and the memory (e.g. paragraphs 0027, 0119), the processing device configured to:
perform, using the set of electrodes, an electrocardiogram (ECG) of the user (e.g. paragraph 0119), the ECG comprising a set of ECG waveforms corresponding to leads formed by the set of electrodes (e.g. paragraph 0119).
However, Kranz does not explicitly teach the housing having a circular shape and the housing comprising a socket configured to removably couple to a cable as well as synthesize a second set of ECG waveforms of the user based on the set of ECG waveforms, the second set of ECG waveforms corresponding to leads not formed by the set of electrodes.
Kranz, in another embodiment, discloses a socket configured to removably couple to a cable (e.g. Fig. 44 – pin connector 779 and socket connector 780).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kranz to include a socket that is configured to removably couple to a cable, as taught and suggested by another embodiment of Kranz, in order to provide the predictable results of allowing the use of interchangeable different type of electrode arrays as well as allowing for the cables to be changed/replaced when necessary.
However, the modified Kranz reference still does not explicitly teach the housing having a circular shape as well as synthesize a second set of ECG waveforms of the user based on the set of ECG waveforms, the second set of ECG waveforms corresponding to leads not formed by the set of electrodes.
Albert, in a same field of endeavor of electrocardiogram devices, discloses a housing having a circular shape (e.g. paragraph 00019).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kranz to incorporate a circular shape for the housing, as taught and suggested by Albert, because it is a simple substitution of one known shape for a housing for another in order to obtain the predictable results of effective electrocardiogram monitoring.
However, Kranz in view of Albert does not explicitly teach synthesizing a second set of ECG waveforms of the user based on the set of ECG waveforms, the second set of ECG waveforms corresponding to leads not formed by the set of electrodes.
Schreck, in a same field of endeavor of electrocardiogram devices, discloses synthesizing a second set of ECG waveforms of the user based on the set of ECG waveforms, the second set of ECG waveforms corresponding to leads not formed by the set of electrodes (e.g. paragraphs 056-0058, – using leads I, aVF, and V2 to derive/synthesize additional leads (i.e. leads III, aVR, V3, etc.)).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Kranz and Albert to incorporate synthesizing a second set of ECG waveforms of the user based on the set of ECG waveforms, the second set of ECG waveforms corresponding to leads not formed by the set of electrodes, as taught and suggested by Schreck, for the purpose of obtaining additional electrical viewpoints of the heart so that a clinician can provide a more accurate diagnosis to a patient.
Regarding claim 10, Kranz in view of Albert in view of Schreck teaches the apparatus of claim 9 as discussed above, and Kranz further teaches wherein the set of electrodes comprises: a first electrode and a second electrode positioned on a top side of the housing to contact the first and the second location of the user respectively (e.g. Fig. 8 – element 446 has two electrodes); and a third electrode are positioned on a bottom side of the housing to contact a third location of the user (e.g. Fig. 8 – element 447), wherein the processing device performs a two-lead ECG (e.g. paragraph 0119, 0130).
Regarding claim 11, Kranz in view of Albert in view of Schreck teaches the apparatus of claim 9 as discussed above, and Kranz further teaches wherein the set of electrodes comprises: a first electrode positioned on a top side of the housing to contact the first location of the user (e.g. Fig. 8 – element 446); and a second electrode positioned on a bottom side of the housing to contact the second location of the user (e.g. Fig. 8 – element 447), wherein the processing device performs a single-lead ECG (e.g. paragraph 0108, 0119).
Regarding claim 12, Kranz in view of Albert in view of Schreck teaches the apparatus of claim 9 as discussed above, and Kranz further teaches wherein the processing device is further configured to: determine one or more diagnoses based on the first and second set of ECG waveforms (e.g. paragraphs 0132, 0183).
Regarding claim 13, Kranz in view of Albert in view of Schreck teaches the apparatus of claim 12 as discussed above, and Kranz further teaches wherein the housing further comprises: a transceiver to transmit the one or more diagnoses to a computing device (e.g. paragraph 0126).
Regarding claim 15, Kranz teaches a system comprising:
an electrocardiogram (ECG) monitoring (e.g. Fig. 8) device comprising:
a first housing (e.g. Fig. 8 – housing of element 448) comprising
a first set of electrodes to contact a first location and second location of a user (e.g. Fig. 8 – electrodes 449 and 450);
a cable (e.g. Fig. 8 – element 1032);
and a second housing (e.g. Fig. 8 – element 445 multi-channel base), the second housing operatively coupled to the first housing via the cable (e.g. Fig. 8 – element 1032), the second housing (e.g. Fig. 8 – element 445 multi-channel base) further comprising:
a second set of electrodes to contact a third location and a fourth location of the user (e.g. Fig. 8 – electrodes 446 and 447);
a memory (e.g. paragraphs 0027, 0119);
and a processing device operatively coupled to the second set of electrodes and the memory (e.g. paragraphs 0027, 0119), the processing device configured to:
measure, using the first and second set of electrodes, a first set of electrocardiogram (ECG) waveforms of the user (e.g. paragraph 0119), the first set of ECG waveforms corresponding to leads formed by the first and second set of electrodes (e.g. paragraph 0119); and determine one or more diagnoses based on the first and second set of ECG waveforms (e.g. paragraphs 0119, 0183);
and a computing device (e.g. Fig. 11 – PC 962; paragraph 0126) to:
provide instructions to the user for placing the ECG monitoring device on a body of the user such that each of the set of electrodes is contacting a respective location of the user (e.g. paragraphs 0119, 0126 – additionally this limitation contains functional language (see MPEP 2114) and is the intended use of the device. The device of the prior art is interpreted to be fully capable of performing this function and therefore meets the scope of the limitation); and receive the determined one or more diagnoses from the ECG monitoring device (e.g. Fig. 11; paragraphs 0119, 0126).
However, Kranz does not explicitly teach the second housing having a circular shape and the second housing comprising a socket in which the cable is removably attached as well as synthesize a second set of ECG waveforms of the user based on the first set of ECG waveforms, the second set of ECG waveforms corresponding to all leads not formed by the first set of electrodes and the second set of electrodes together.
Kranz, in another embodiment, discloses a socket in which the cable is removably attached (e.g. Fig. 44 – pin connector 779 and socket connector 780).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kranz to include a socket in which the cable is removably attached, as taught and suggested by another embodiment of Kranz, in order to provide the predictable results of allowing the use of interchangeable different type of electrode arrays as well as allowing for the cables to be changed/replaced when necessary.
However, the modified Kranz reference still does not explicitly teach the second housing having a circular shape as well as synthesize a second set of ECG waveforms of the user based on the first set of ECG waveforms, the second set of ECG waveforms corresponding to all leads not formed by the first set of electrodes and the second set of electrodes together.
Albert, in a same field of endeavor of electrocardiogram devices, discloses a housing having a circular shape (e.g. paragraph 00019).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kranz to incorporate a circular shape for the housing, as taught and suggested by Albert, because it is a simple substitution of one known shape for a housing for another in order to obtain the predictable results of effective electrocardiogram monitoring.
However, Kranz in view of Albert does not explicitly teach synthesizing a second set of ECG waveforms of the user based on the first set of ECG waveforms, the second set of ECG waveforms corresponding to all leads not formed by the first set of electrodes and the second set of electrodes together.
Schreck, in a same field of endeavor of electrocardiogram devices, discloses synthesizing a second set of ECG waveforms of the user based on the first set of ECG waveforms, the second set of ECG waveforms corresponding to all leads not formed by the first set of electrodes and the second set of electrodes together as well as determining one or more diagnoses (e.g. paragraphs 056-0058, – using leads I, aVF, and V2 to derive/synthesize additional leads (i.e. leads III, aVR, V3, etc.); paragraphs 0067-0068).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Kranz and Albert to incorporate synthesizing a second set of ECG waveforms of the user based on the first set of ECG waveforms, the second set of ECG waveforms corresponding to all leads not formed by the first set of electrodes and the second set of electrodes together, as taught and suggested by Schreck, for the purpose of obtaining additional electrical viewpoints of the heart so that a clinician can provide a more accurate diagnosis to a patient.
Regarding claim 17, Kranz in view of Albert in view of Schreck teaches the system of claim 15 as discussed above, and Kranz further teaches wherein the second housing further comprises: a transceiver to transmit the one or more diagnoses to the computing device (e.g. paragraph 0126 – additionally this limitation contains functional language (see MPEP 2114) and is the intended use of the device. The device of the prior art is interpreted to be fully capable of performing this function and therefore meets the scope of the limitation).
Regarding claim 18, Kranz in view of Albert in view of Schreck teaches the system of claim 15 as discussed above, and Kranz further teaches wherein the computing device further comprises: a display to display the determined one or more diagnoses (e.g. Fig. 11 – element 962; paragraph 0126, – a PC inherently has a display).
Regarding claim 19, Kranz in view of Albert in view of Schreck teaches the system of claim 15 as discussed above, and Kranz further teaches wherein: one or more of the first set of electrodes are positioned on a top side of the first housing to contact the first location of the user (e.g. Fig. 8 – electrode 449) and one or more of the first set of electrodes are positioned on a bottom side of the first housing to contact the second location of the user (e.g. Fig. 8 – electrode 450); and one or more of the second set of electrodes are positioned on a top side of the second housing to contact the third location of the user (e.g. Fig. 8 – element 446) and one or more of the second set of electrodes are positioned on a bottom side of the second housing to contact the fourth location of the user (e.g. Fig. 8 – element 447).
Regarding claim 20, Kranz in view of Albert in view of Schreck teaches the system of claim 15 as discussed above, and Kranz further teaches wherein the first, second, third, and fourth locations of the user correspond to a right arm, chest, left arm, and left leg of the user respectively (e.g. paragraph 0119 – additionally this limitation contains functional language (see MPEP 2114) and is the intended use of the device. The device of the prior art is interpreted to be fully capable of performing this function and therefore meets the scope of the limitation).
Claims 8 and 14 are rejected under 35 U.S.C 103 as being unpatentable over Kranz and further in view of Albert and further in view of Schreck and further in view of Vajdic et al. (US Pub.: US 2021/0219902 A1, – Previously Cited).
Regarding claim 8, Kranz in view of Albert in view of Schreck teaches the
apparatus of claim 1 as discussed above. However, Kranz in view of Albert in view of Schreck does not explicitly teach wherein each of the first set of electrodes and each of the second set of electrodes comprises an adhesive material to maintain contact between the electrode and a respective location of the user.
Vajdic, in a same field of endeavor of electrocardiogram devices, discloses wherein each of the first set of electrodes and each of the second set of electrodes comprises an adhesive material to maintain contact between the electrode and a respective location of the user (e.g. paragraph 0168).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Kranz, Albert, and Schreck to incorporate adhesive material to the electrodes, as taught and suggested by Vajdic, in order to provide the predictable results of improving electrode contact as well as increasing the accuracy of the measured electrocardiogram data by reducing the movement of the electrodes.
Regarding claim 14, Kranz in view of Albert in view of Schreck teaches the
apparatus of claim 9 as discussed above. However, Kranz in view of Albert in view of Schreck does not explicitly teach wherein each of the set of electrodes comprises an adhesive material to maintain contact between the electrode and a respective location of the user.
Vajdic, in a same field of endeavor of electrocardiogram devices, discloses wherein each of the set of electrodes comprises an adhesive material to maintain contact between the electrode and a respective location of the user (e.g. paragraph 0168).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Kranz, Albert, and Schreck to incorporate adhesive material to the electrodes, as taught and suggested by Vajdic, in order to provide the predictable results of improving electrode contact as well as increasing the accuracy of the measured electrocardiogram data by reducing the movement of the electrodes.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL TEHRANI whose telephone number is (571)270-0697. The examiner can normally be reached 9:00am-5:00pm.
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/D.T./Examiner, Art Unit 3792
/Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792