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 .
Claims Accounting
Applicant' s arguments, filed 08 October 2025, have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicants have amended their claims, filed 08 October 2025, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Claims 1 has been amended.
Claims 21 and 22 have been newly presented.
Claims 1-9 and 21-22 are the current claims hereby under examination.
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.
Claims 1-9, 21, and 22 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 1, the claim recites “without using the respiratory wire for measuring any ECG data” in lines 9-10 and “the respiratory wire therefore being dedicated for measuring the respiratory electrical activity by not being used for measuring any ECG data” in lines 12-13. It is unclear how the respiratory wire is not being used for measuring any ECG data. Any electrodes placed on the body will collect data that contains ECG artifacts or voltage references that may be used for ECG. Therefore it is unclear how the respiratory wire is capable of not measuring any ECG data while being used for measuring respiratory data. Clarification is requested.
For the purposes of examination, the claim is interpreted as “without using the respiratory wire for measuring any of the first set of cardiac electrical activity” and “the respiratory wire therefore being dedicated for measuring the respiratory electrical activity by not being used for measuring any of the first set of cardiac electrical activity”.
All claims not explicitly addressed above are rejected under 35 U.S.C. 112(b) are rejected by virtue of their dependency on a rejected base claim.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-6, 21, and 22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Patent 7,351,208 B2 by Brodnick et al., (hereby referred to as "Brodnick" – previously cited).
Regarding claim 1, Brodnick teaches
A system for measuring electrocardiogram (ECG) data and respiratory data (Fig. 1, Col. 3, lines 55-57, “respiration monitoring system 100 which includes an ECG monitor 102”) for a patient, the system comprising:
at least four ECG wires (Fig. 1, electrical lead wires 104) configured to communicate a first set of cardiac electrical activity (Col. 4, lines 10-20, monitor is capable of monitoring ECG signals using standard leads (may be 4-12 leads)) from the patient;
a respiratory wire distinct from the at least four ECG wires (Fig 1 depicts five wires, four of which are considered the at least four ECG wires and the remaining one being the respiratory wire. It is also noted that Brodnick teaches there may be more than five wires (Wires may be attached at any of the positions shown in Figs. 2-3, such as HV5R, HV6R, V5R or V6R); Col. 3, line 58 through Col. 4 line 2 teaches that some electrodes are connected to the monitor 102 through wires 104, and several are not used for respiration, but for ECG.) and configured to communicate respiratory electrical activity from the patient (Col. 4, lines 41-51, configured to produce a respiration parameter for a patient); and
a control system (Fig. 1, Col. 3, lines 55-57, monitor 102) electrically coupled to the at least four ECG wires and to the respiratory wire (Fig. 1, Col. 3, lines 55-57, monitor 102 and electrical lead wires 104 that are connected to monitor 102 at one end), wherein the control system is configured to measure the ECG data based on the first set of cardiac electrical activity from the at least four ECG wires (Col.5, lines 9-14, “The electrodes receive signals generated by the heart and transmit these signals through the ECG lead wires to monitor 102. Monitor 102 amplifies and processes these signals and displays them on the monitor's display screen as traces.”) without using the respiratory wire for measuring ECG data (Col. 5, lines 15-22 disclose that the ECG circuits require voltage and that the reference voltage may simply provide a passive low resistance path to ground or it may be connected to an active circuit in monitor 102 typically called a “right leg driver”, therefore the ECG circuit can rely on the right leg driver as its voltage reference instead of a shared wire), and wherein the control system is configured to measure the respiratory data based on the respiratory electrical activity (Col. 4, lines 41-51. The monitor 102 receives input signals from the first electrode to measure the respiration data”) from the respiratory wire (Fig 1, Col. 5, lines 1-3, "Monitor 102 is preferably configured to simultaneously monitor ECG signals at the same time it is monitoring the subject's respiration."), the respiratory wire therefore being dedicated for measuring the respiratory electrical activity by not being used for measuring any ECG data (HV5R, HV6R, V5R or V6R do not need to be shared with the ECG circuit when the ECG circuit uses the right leg driver as the voltage reference).
Regarding claim 2, Brodnick teaches the system according claim 1, wherein the at least four ECG wires and the respiratory wire are each configured to be electrically coupled to the patient via electrodes (Fig. 1, Col.3, lines 64-66 "Several of these electrodes are attached to the other end of corresponding electrical lead wires 104."), and wherein a respiratory electrode (the first electrode of Col. 6, lines 5-8) associated with the respiratory wire is unshared with any of the electrodes associated with the at least four ECG wires (Fig 2, Col 6, lines 5-8, “The first electrode is preferably located on a leg, more preferably on a leg on the side of the thorax ipsilateral (same side as) the heart, more particularly at the LL or RL locations.” Fig 2 shows the positions of the electrodes configured for ECG: V1-V6, LA, and RA (Col. 3, lines 58-64) being unshared with HV5R, HV6R, V5R, V6R, LL, or RL). It is noted that there are multiple configurations in which the at least four ECG wires do not share a wire with the electrodes associated with the respiratory wire.
Regarding claim 3, Brodnick teaches the system according claim 1, wherein the control system receives additional electrical activity measured on the patient (Col. 4, lines 52-57; the second electrode is used to measure impedance between it and the first electrode), and wherein the control system measures the respiratory data by analyzing the respiratory electrical activity and the additional electrical activity (col. 4, lines 52-57) measured on the abdomen of the patient.
It is noted that the electrode used to measure the additional electrical activity is capable of measuring the additional electrical activity from an abdomen of the patient (Col. 6, lines 9-17: “Of course, non-standard positions may also be used.”).
Regarding claim 4, Brodnick teaches the system according to claim 3, wherein the additional electrical activity is communicated via one of the at least four ECG wires (as applied in claim 3 of this Office action, second electrode is one of the plurality of inputs coupled to the processing circuit (Col. 4, lines 41-46) via wires (Fig 1. electrical lead wires 104) which is connected by one of the at least four ECG wires to the monitor 102.).
One of the at least four ECG wires as applied in claim 1 is capable of being placed on the abdomen and used as the additional electrical activity (Col. 6 lines 16-17; “Of course, non-standard positions may also be used”).
Regarding claim 5, Brodnick teaches the system according claim 1, wherein the system is configured such that the respiratory electrical activity is measured via an electrode positioned closer to a left armpit of the patient than to a sternum of the patient. Col. 6, lines 9-35 teaches using the second electrode at an armpit area, and using signals from that second electrode to determine respiratory electrical activity.
Regarding claim 6, Brodnick teaches the system according claim 1, wherein the respiratory wire is a first respiratory wire and the respiratory electrical activity is a first set of respiratory electrical activity measured in a first location on the patient and communicated by the first respiratory wire (First electrode and corresponding wire is the first electrical activity (Col. 2, lines 15-17), further comprising a second respiratory wire configured to communicate a second set of respiratory electrical activity measured in a second location on the patient (Col. 2, lines 15-17, second electrode and corresponding wire is the second electrical activity), wherein the control system receives additional electrical activity measured on the patient, and wherein the control system measures the respiratory data by analyzing the first set of respiratory electrical activity and the second set of respiratory electrical activity to the additional electrical activity (Col. 2, lines 20-25, the first and second electrodes are used to measure the respiratory parameter and the third electrode is used as a reference, wherein the third electrode is used is compared to both the first and second set).
Regarding claim 21, Brodnick teaches the system according to claim 1, wherein the at least four ECG wires and the respiratory wire are within an actual number of wires electrically coupling the patient to the control system (See the rejection of claim 1, the at least four ECG wires and the respiratory wire coupled the electrodes on the body of the subject to the control system), wherein the control system is configured to receive the first set of cardiac electrical activity collectively from all of the actual number of wires except for the respiratory wire (Each of the wires may be used to collect cardiac electrical activity except for the respiratory wire, which is coupled to an electrode at HV5R, HV6R, V5R or V6R. This wire does not need to be shared with the ECG circuit when the ECG circuit uses the right leg driver as the voltage reference).
Regarding claim 22, Brodnick teaches the system according to claim 21, wherein the actual number is at least six wires (The at least four ECG wires may comprise a conventional 12-lead ECG configuration (Col. 3, lines 58-64, “System 100 also includes a complete or partial subset of electrodes RA, RL, LA, LL, V1, V2, V3, V4, V5, and V6 (i.e., electrodes configured to be mounted to the subject's body at the standard RA, RL, LA, LL, V1, V2, V3, V4, V5, and V6 electrode locations).).
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.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Brodnick, as applied to claim 1, in view of Burks US Patent 7,215,989 B1 (hereby referred to as “Burks” – previously cited).
Brodnick teaches the system according to claim 1.
Brodnick further teaches electrodes by which the at least four ECG wires and the respiratory wire receive the first set of cardiac electrical activity and the respiratory electrical activity from the patient, respectively (Col.3, lines 58-67).
However, Brodnick is silent regarding one of the electrodes is configured to communicate with two separate wires among the respiratory wire and the at least four ECG wires.
Burks teaches a single electrode assembly 10 with multiple lead attachments 14 (Fig. 4, Col. 57-60) that allows for multiple wired connections. Burks is considered to be in the same field of endeavor as Brodnick, as they are both in the field of ECG sampling.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Brodnick such that the HV6R and HV5R leads shown in Figure 3 are connected to a single electrode assembly with multiple lead attachments, as Burks teaches that this would reduce costs since fewer assemblies would be used than would ordinarily be required (Burks Col. 3, lines 46-50). The modification to Brodnick would combine prior art elements according to known methods to yield predictable results (See MPEP § 2143 I(A)).
Claims 8 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Brodnick, as applied to claim 1.
Regarding claim 8, Brodnick teaches the system of claim 1.
Figure 4 of Brodnick further teaches wherein the control system (monitor 102) comprises a first control system (element 206; Col. 6, lines 42-59), and a second control system (element 202) separate from the first control system (It can be seen in Fig. 4 that element 202 and the element 206 are separate within the patient monitor 102) and electrically coupled to additional ECG wires (Col. 4, lines 41-43 “Monitor 102 is a patient monitoring system which includes a plurality of inputs being configured to be coupled to the plurality of electrodes as noted above”, and Col. 6, lines 42-59), configured to communicate additional cardiac electrical activity measured from the patient (Col. 4, lines 10-12, “monitor 102 is also capable of monitoring ECG signals using standard leads”), wherein the ECG data is measured based on the first set of cardiac electrical activity from the at least four ECG wires and also the additional cardiac electrical activity from the additional ECG wires (Col. 5, lines 9-14, "The ECG circuits of monitor 102 include amplifier circuits. The electrodes receive signals generated by the heart and transmit these signals through the ECG lead wires to monitor 102. Monitor 102 amplifies and processes these signals and displays them on the monitor's display screen as traces.”).
While Figure 4 of Brodnick shows the various control systems of the control system (patient monitor 102), it fails to explicitly recite that the control system is coupled to the at least four ECG wires and the respiratory wire. However, one of ordinary skill in the art would realize that the control systems are either coupled via a wired, electrical connection or via a wireless connection. As such, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the first control system 206 is electrically coupled to the second control system 202, as it would be choosing from a finite number of identified, predictable solutions (connecting control system via electrical coupling or via a wireless connection), with a reasonable expectation of success (See MPEP § 2143 I(E)). As modified, the first control system 206 of Brodnick would be electrically coupled to the at least four ECG wires and the respiratory wire via its electrical connections to elements 202 and 204 of Figure 4.
Regarding claim 9, Brodnick teaches the system of claim 8.
Brodnick further teaches wherein the additional ECG wires are leads V2 through V6 in a conventional 12-lead ECG configuration (Col. 3, lines 58-64, “System 100 also includes a complete or partial subset of electrodes RA, RL, LA, LL, V1, V2, V3, V4, V5, and V6 (i.e., electrodes configured to be mounted to the subject's body at the standard RA, RL, LA, LL, V1, V2, V3, V4, V5, and V6 electrode locations), as well as one or more electrodes located at non-standard locations HV5, HV6, V5R, V6R, HV5R, and HV6R.”).
Response to Arguments
Applicant's arguments filed 08 October 2025 have been fully considered.
Applicant argues that Brodnick does not teach any respiratory electrode/wire/lead that is used for only respiration purposes, and not for measuring any ECG data. Brodnick teaches the limitations recited in the claims as the monitoring configuration may include leads connected to electrodes at each of the locations shown in Fig. 2 (Col 3, lines 36-40 and 58-64). Respiration monitoring can be done with electrode positions using a vector extending from a leg on one side of the subject's body to the subject's upper thorax on the opposing side of the body (Col. 6, lines 1-4). The ECG monitoring may use the right leg driver as the voltage reference (Col. 5, lines 15-22). The respiratory wire can be defined as either of the other wires not used for ECG, but used for respiration, such as any of the wires extending from the electrodes at the positions on subject's upper thorax on the opposing side of the body (this can include HV5R, HV6R, V5R or V6R). If the right leg driver is used as the ECG voltage reference, then the wires extending from electrodes placed at HV5R, HV6R, V5R or V6R are used only for collecting respiratory electrical activity, and not a first set of cardiac respiratory activity.
During the interview on 18 September 2025, the parties agreed that Brodnick does not explicitly state that the system comprises a “dedicated” respiratory wire. However, during the interview, the examiners asserted that the system of Brodnick can be configured as a 12-lead system with additional leads for respiration monitoring. Examiners further asserted that any of the additional leads for respiration monitoring can be considered a respiratory wire, and the respiratory data of Brodnick is based on the respiratory electrical activity from the respiratory wire. The additional leads may comprise leads such as (V5R, HV5R, V6R, or HV6R) and do not need to be shared with the ECG monitoring circuit, as the ECG circuit may utilize a right leg driver for its voltage reference.
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).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NELSON A GLOVER whose telephone number is (571)270-0971. The examiner can normally be reached Mon-Fri 8:00-5:00 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jason Sims can be reached at 571-272-7540. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/NELSON ALEXANDER GLOVER/Examiner, Art Unit 3791
/ETSUB D BERHANU/Primary Examiner, Art Unit 3791