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
This action is pursuant to the claims filed on 07/12/2024. Claims 1-20 are pending. A first action on the merits of claims 1-20 is as follows.
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 18-20 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.
Claims 18, 19, and 20 each recite dependency to claim 1. Claims 18-20 are recited as method claims referring to a base apparatus claim in claim 1. Such claimed dependency also introduces numerous antecedent basis issues. However, it appears claims 18-20 are intended to claim dependency to method claim 15. As such, these claims will be interpreted to be dependent from claim 15 to cure these deficiencies.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 3-4, 6-8, 10-12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wenger (U.S. PGPub No. 2004/0210149).
Regarding claim 1, Wenger teaches A wearable device for generating electrocardiogram data, the wearable device comprising a chest strap having an interior side and an opposing exterior side (Fig 5 chest mask 11) and a plurality of precordial electrodes disposed around the interior side (Fig 5 ECG sensors 15 on inner side of strap to contact skin for ECG measurement).
Regarding claim 3, Wenger teaches wherein the plurality of precordial electrodes comprises one or more electrodes each corresponding to a position selected from the group consisting of V3R, V4R, V5R, and V6R (see Figs 4-5).
Regarding claim 4, Wenger teaches wherein the electrodes are disposed in two or more rows around the interior side (Fig 5, electrodes are arranged in at least 3 or more rows).
Regarding claim 6, Wenger teaches wherein the electrodes comprise two or more electrodes for each of one or more precordial positions (Fig 3, V5 and V6 positions comprise two or more electrodes for the same precordial position dependent on patient size)
Regarding claim 7, Wenger teaches one or more visual indicators disposed on the exterior side of the strap, wherein the one or more visual indicators each independently indicate position and/or orientation of the chest strap or collectively indicate position and/or orientation of the chest strap (see Fig 5 and the plurality of visual indicators as claimed).
Regarding claim 8, Wenger teaches wherein the one or more visual indicators comprises a graphical indicator, a physical indicator, or both (see Figs 3-5 and plurality of visual and graphical indicators).
Regarding claim 10, Wenger teaches wherein the one or more visual indicators comprise a graphical indicator disposed on a physical indicator (Fig 4, indicator 33 comprises line (graphical) indicator 33 with the word (physical) indicator thereon).
Regarding claim 11, Wenger teaches wherein the one or more visual indicators comprises a sternum indicator (Fig 4 sternum indicator 33).
Regarding claim 12, Wenger teaches wherein the strap comprises elastic or spandex ([0048] device formed of elastic material).
Claim(s) 15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Crawford (U.S. PGPub No. 2011/0125040).
Regarding claim 15, Crawford teaches A method for alerting a user to a likelihood of a health emergency for the user, the method comprising: notifying, by a processor of a computing device, the user to obtain an electrocardiogram using, at least in part, a wearable (Fig 8A, [0056]); receiving, by the processor, electrocardiogram data generated from one or more electrodes comprised in the wearable (Fig 8B [0056]); and generating, by the processor, the electrocardiogram based, at least in part, on the electrocardiogram data (see Fig 8B [0056]).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 2, 9, 13-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wenger (U.S. PGPub No. 2004/0210149) in view of McClung (U.S. PGPub No. 2022/0175292).
Regarding claim 2, Wenger teaches the device of claim 1 as stated above.
Wenger fails to teach wherein the plurality of precordial electrodes comprises one or more electrodes each corresponding to a position selected from the group consisting of V7, V8, and V9.
In related prior art, McClung teaches wherein the plurality of precordial electrodes comprises one or more electrodes each corresponding to a position selected from the group consisting of V7, V8, and V9 (Fig 3, electrode positions V7-V9). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Wenger in view of McClung to incorporate electrodes V7-V9 to arrive at claim 2. Doing so would advantageously provide more ECG electrodes to provide more views of the heart in ECG readings for improved diagnostic and monitoring purposes.
Regarding claim 9, Wenger teaches the device of claim 8 as stated above, Wenger teaches wherein the one or more visual indicators comprises a physical indicator (Fig 4, indicator 33 comprises line (graphical) indicator 33 with the word (physical) indicator thereon).
Wenger fails to teach the physical indicator houses a data module and/or a wireless module
McClung teaches a similar device wherein a physical indicator houses a data module and/or wireless module (Fig 2 wireless transmitter 175 is located within electrode connector 170 and defines a physical indicator (i.e., shape and protrusions of device can be interpreted as a “physical indicator”)). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Wenger in view of McClung to incorporate a wireless transmitter within a physical indicator of the device to arrive at claim 9. Doing so would advantageously provide the device as wireless without an necessary external wires connecting to a processor or data module to provide a more comfortable user experience.
Regarding claim 13, Wenger teaches the device of claim 1 as stated above.
Wenger fails to teach wherein the strap comprises a closure.
McClung further teaches wherein the strap comprises a closure (Fig 3 and [0108] disclosing hook and loop closures for adjustment). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the attachment mechanism of Wenger in view of McClung to incorporate the closure to arrive at claim 13. Doing so would advantageously provide the strap with the ability to fully enclose around a subject for secure attachment while providing adjustable straps for heat and girth adjustments ([0108]).
Regarding claim 14, Wenger teaches the device of claim 1 as stated above, and further teaches electrodes corresponding to 6 precordial leads (see Figs 3-5)
Wenger fails to teach wherein the plurality of precordial electrodes correspond to V7, V8, and V9.
In related prior art, McClung teaches wherein the plurality of precordial electrodes comprises one or more electrodes each corresponding to a position selected from the group consisting of V7, V8, and V9 (Fig 3, electrode positions V7-V9). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Wenger in view of McClung to incorporate electrodes V7-V9 to arrive at claim 14. Doing so would advantageously provide more ECG electrodes to provide more views of the heart in ECG readings for improved diagnostic and monitoring purposes.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wenger (U.S. PGPub No. 2004/0210149) in view of Dabby (U.S. PGPub No. 2018/0271441).
Regarding claim 5, Wenger teaches the device of claim 4 as stated above.
Wenger fails to teach wherein the two or more rows comprise electrodes for identical precordial positions.
In related prior art, Dabby teaches a similar device wherein the two or more rows comprise electrodes for identical precordial positions (Fig 1 with rows of electrodes 120 that can correspond to identical precordial positions; [0013] disclosing ECG measurement with electrodes/sensors). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Wenger in view of Dabby to incorporate two or more rows of electrodes corresponding to identical precordial positions to arrive at claim 5. Duplicating a row of electrodes of Wenger would advantageously increase the number of physiological signals capable of being measured from the heart to provide for a better and more complete view of the heart during physiological monitoring.
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Crawford in view of Albert (U.S. PGPub No. 2020/0375458).
Regarding claim 16, Crawford teaches the method of claim 15 as stated above.
Crawford fails to teach capturing one or more images with a camera, by the processor; analyzing, by the processor, at least a portion of the one or more images to identify a location of a torso of the user; displaying, by the processor, an icon corresponding to a correct position and/or orientation of the wearable on the user relative to location of the torso of the user; and optionally, indicating, by the processor, to the user when the position and/or orientation of the strap is correct.
In related prior art, Albert teaches capturing one or more images with a camera, by the processor ([0121]); analyzing, by the processor, at least a portion of the one or more images to identify a location of a torso of the user ([0121] processor compares picture to database of electrode placement which implicitly requires identification of a torso); displaying, by the processor, an icon corresponding to a correct position and/or orientation of the wearable on the user relative to location of the torso of the user ([0121] processor presents an image of patient showing positions for conventional ECG electrode positions on the taken image); and optionally, indicating, by the processor, to the user when the position and/or orientation of the strap is correct (Examiner notes this limitation is recited in the alternative and need not be taught by the prior art). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Crawford in view of Albert to incorporate the step of capturing an image and analyzing the image to determine correct electrode position on the torso as claimed to arrive at claim 16. Doing so would advantageously allow for an inexperienced user to accurately position the electrodes as needed on the torso to acquire a quality ECG recording.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Crawford in view of Ambrose (U.S. PGPub No. 2005/0085736).
Regarding claim 17, Crawford teaches the method of claim 15 as stated above.
Crawford fails to teach determining, by the processor, whether ST-segment elevation is or may be indicated in the electrocardiogram.
In related prior art, Ambrose teaches a similar method comprising determining, by the processor, whether ST-segment elevation is or may be indicated in the electrocardiogram ([0007], [0059-0060] and Fig 5b). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Crawford in view of Ambrose to incorporate the step of determining whether ST-segment elevation is or may be indicated in the ECG to arrive at claim 17. Doing so would advantageously enable the device and method to detect potential myocardial infarction ([0007]).
Claim(s) 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Crawford in view of McClung.
Regarding claims 18-19, Crawford teaches the method of claim 15 as stated above.
Crawford fails to teach wherein the one or more electrodes comprises one or more electrodes each independently in a position selected from the group consisting of: V7, V8, V9, V3R, V4R, V5R, and V6R; wherein the electrocardiogram comprises at least (e.g., exactly) 9 precordial leads.
In related prior art, McClung teaches wherein the one or more electrodes comprises one or more electrodes each independently in a position selected from the group consisting of: V7, V8, V9, V3R, V4R, V5R, and V6R; wherein the electrocardiogram comprises at least 9 precordial leads (see Fig 3 comprising at least 9 precordial leads and V7-9 and V3R-V6R as claimed) Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Crawford in view of McClung to incorporate the increased number of precordial electrodes as claimed to arrive at claims 18-19. Doing so would advantageously provide more ECG electrodes to provide more views of the heart in ECG readings for improved diagnostic and monitoring purposes.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Crawford in view of Vajdic (U.S. PGPub No. 2021/0219902).
Regarding claim 20, Crawford teaches the method of claim 15 as stated above.
Crawford fails to teach receiving, by the processor, patient history data for the user; receiving, by the processor, current health data from the user, the current health data comprising the electrocardiogram; and determining, by the processor, one or more probabilistic measurements at least in part by comparing the current health data to the patient history data, the one or more probabilistic measurements corresponding to the likelihood of a health emergency.
In related prior art, Vajdic teaches receiving, by the processor, patient history data for the user ([0029] method includes receiving an initial baseline ECG measurement); receiving, by the processor, current health data from the user, the current health data comprising the electrocardiogram ([0104] “test recording” is the current health data); and determining, by the processor, one or more probabilistic measurements at least in part by comparing the current health data to the patient history data ([0104] heath data is compared to baseline), the one or more probabilistic measurements corresponding to the likelihood of a health emergency ([0104-0105] comparison of baseline recording to current recording that results in a difference is used to determine a health emergency) .
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Adam Z Minchella whose telephone number is (571)272-8644. The examiner can normally be reached M-Fri 7-3 EST.
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/ADAM Z MINCHELLA/Primary Examiner, Art Unit 3794