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 .
DETAILED ACTION
Response to Arguments
Applicant’s arguments, see pages 6-8, filed 01/14/2026, with respect to the rejection(s) of claims 1-17 under non-statutory double patenting, and of claims 8-13 under 35 U.S.C. 112(b), and of claims 1-17 under 35 U.S.C. 102(a)(1) have been fully considered and are persuasive. Therefore, the rejections have been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Sullivan et al (US 2005/0015115).
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 1-7 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.
Claims 2-7 comprise preamble directed toward the method of claim 1; however, claim 1 is directed to a system comprising a recording device and lacks a clearly defined method.
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.
Claims 1-17 are rejected under 35 U.S.C. 103 as being unpatentable over Sullivan et al (US 2016/0135706) in view of Sullivan et al (2005/0015115).
Regarding claim 1, Sullivan ‘706 discloses a system for assisting in obtaining ECG waveforms from a patient comprising:
an ECG recording device 100 comprising:
one or more electrodes 112 configured to detect bioelectric impedance on a patient;
a measuring device 305 configured to receive raw data from the electrodes and generate an ECG waveform; and a
transceiver 539 configured to transmit and receive data;
an analysis server 8065 configured to analyze processed ECG data, see paragraph [0506];
wherein the ECG recording device 100 is programmed to:
sense an initial ECG waveform from the patient using the ECG recording device in a first
lead configuration, see paragraph [0353];
generate an initial analysis at the ECG recording device based on the ECG waveform obtained from the patient by the recording device, see paragraph [0364];
communicate the recorded ECG waveform and the initial analysis from the recording device to the analysis server;
receive a recommended action from the analysis server, see paragraph [0514]; and
operate to carry out the recommended action on the patient; wherein the analysis server is programmed to:
analyze the recorded ECG waveform and the initial analysis;
determine the recommended action, see paragraphs [0311] [0513].
Sullivan ‘706 teaches the ECG signal may be received from any appropriate source of patient ECG data. For example, ECG data may be received real time from two or more or three or more ECG electrodes attached to a patient or previously recorded data can be received from a storage device, see paragraph [0408].
Sullivan ‘115 teaches an expanded electrode set can be used to detect ECG signals more efficiently than using two electrodes 14 and 16, and can be used to provide a more thorough analysis of a condition of the heart of patient 8, see paragraph [0049].
Clearly, Sullivan ‘706 teaches sensing multiple ECG waveforms. One of ordinary skill in the art would have found it obvious to sense a second ECG waveform using a different lead configuration than a first lead configuration to provide a more thorough analysis of a condition of the heart as suggested by Sullivan ‘115.
The use of a different lead configuration rendered obvious over Sullivan ‘706 in view of Sullivan ‘115 is not limited to an initial patient monitoring, or any cardiac monitoring where an initial first configuration using two or three electrodes yields a cardiac condition requiring a more thorough analysis using a twelve lead configuration with a second ECG sensed waveform.
Thus, it is obvious to communicate the recommended action to the recording device, see paragraph [0514] in Sullivan ‘706, wherein the recommended action comprises sensing a second ECG waveform using a different lead configuration than the first lead configuration.
Regarding claims 2, 9 and 15, Sullivan ‘706 in view of Sullivan ‘115 render obvious the different lead configuration comprises a configuration having different leads than the first lead configuration, see paragraph [0353] in Sullivan ‘706.
Regarding claims 3, 10 and 16, Sullivan ‘706 in view of Sullivan ‘115 render obvious the different lead configuration comprises a configuration having a different amount of leads than the first lead configuration, see paragraph [0408] in Sullivan ‘706 and paragraph [0049] in Sullivan ‘115.
Regarding claim 4 and 11, Sullivan ‘706 in view of Sullivan ‘115 render obvious the analysis server is programmed to determine the recommended action by:
comparing the initially sensed ECG waveform to previous patient ECG waveforms using machine learning; and
generating the recommended action based on machine learning analysis, see paragraphs [0300] and [0379] in Sullivan ‘706.
Regarding claims 5 and 12, Sullivan ‘706 in view of Sullivan ‘115 render obvious the recommended action is communicated to the recording device 100 while the patient is at the recording device 100, see paragraph [0513] in Sullivan ‘706.
Regarding claims 6 and 13, Sullivan ‘706 in view of Sullivan ‘115 render obvious the recommended action is determined based on previously determined recommended actions, see paragraph [0514] in Sullivan ‘706.
Regarding claim 7, Sullivan ‘706 in view of Sullivan ‘115 render obvious the recommended action is determined based on previously determined recommended actions associated with the patient, see paragraph [0514] in Sullivan ‘706.
Regarding claim 8, Sullivan ‘706 discloses system for assisting in obtaining ECG waveforms from a patient, comprising:
one or more processors, see paragraph [0261];
one or more memory storing instructions, see paragraph [0261];
wherein the one or more processors are configured to execute the instructions to:
receive, from a recording device 100, an initial ECG waveform sensed from the patient using a first lead configuration and an initial analysis of the ECG waveform;
determine a recommended action based on at least one of the initially sensed ECG waveform and the initial analysis, see paragraphs [0311] and [0513]; and
transmit the recommended action to the recording device 100, see paragraph [0514].
Sullivan ‘706 teaches the ECG signal may be received from any appropriate source of patient ECG data. For example, ECG data may be received real time from two or more or three or more ECG electrodes attached to a patient or previously recorded data can be received from a storage device, see paragraph [0408].
Sullivan ‘115 teaches an expanded electrode set can be used to detect ECG signals more efficiently than using two electrodes 14 and 16, and can be used to provide a more thorough analysis of a condition of the heart of patient 8, see paragraph [0049].
Clearly, Sullivan ‘706 teaches sensing multiple ECG waveforms. One of ordinary skill in the art would have found it obvious to sense a second ECG waveform using a different lead configuration than a first lead configuration to provide a more thorough analysis of a condition of the heart as suggested by Sullivan ‘115.
The use of a different lead configuration rendered obvious over Sullivan ‘706 in view of Sullivan ‘115 is not limited to an initial patient monitoring, or any cardiac monitoring where an initial first configuration using two or three electrodes yields a cardiac condition requiring a more thorough analysis using a twelve lead configuration with a second ECG sensed waveform.
Thus, it is obvious to communicate the recommended action to the recording device, see paragraph [0514] in Sullivan ‘706, wherein the recommended action comprises sensing a second ECG waveform using a different lead configuration than the first lead configuration.
Regarding claim 14, Sullivan ‘706 discloses system for assisting in obtaining ECG waveforms from a patient, comprising:
one or more processors, see paragraph [0261];
one or more memory storing instructions, see paragraph [0261];
wherein the one or more processors are configured to execute the instructions to:
receive, from a recording device 100, an initial ECG waveform sensed from the patient using a first lead configuration and an initial analysis of the ECG waveform, see paragraph [0353];
determine a recommended action based on at least one of the initially sensed ECG waveform and the initial analysis, see paragraphs [0311] and [0513].
Sullivan ‘706 teaches the ECG signal may be received from any appropriate source of patient ECG data. For example, ECG data may be received real time from two or more or three or more ECG electrodes attached to a patient or previously recorded data can be received from a storage device, see paragraph [0408].
Sullivan ‘115 teaches an expanded electrode set can be used to detect ECG signals more efficiently than using two electrodes 14 and 16, and can be used to provide a more thorough analysis of a condition of the heart of patient 8, see paragraph [0049].
Clearly, Sullivan ‘706 teaches sensing multiple ECG waveforms. One of ordinary skill in the art would have found it obvious to sense a second ECG waveform using a different lead configuration than a first lead configuration to provide a more thorough analysis of a condition of the heart as suggested by Sullivan ‘115.
The use of a different lead configuration rendered obvious over Sullivan ‘706 in view of Sullivan ‘115 is not limited to an initial patient monitoring, or any cardiac monitoring where an initial first configuration using two or three electrodes yields a cardiac condition requiring a more thorough analysis using a twelve lead configuration with a second ECG sensed waveform.
Thus, it is obvious to transmit the recommended action to the recording device 100, see paragraph [0514] in Sullivan ‘706, wherein the recommended action comprises sensing a second ECG waveform using a different lead configuration than the first lead configuration.
Regarding claim 17, Sullivan ‘706 discloses one or more processors are configured to execute the instructions to control a display to display information corresponding to the recommended action, see paragraphs [0260], [0266] and [0268].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to George Manuel whose telephone number is (571) 272-4952.
The examiner can normally be reached on regular business days.
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, Benjamin Klein can be reached on (571) 270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/George Manuel/
Primary Examiner
Art Unit: 3792
2/18/2026