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 .
Status of Claims
Claims 1-20 were previously pending and subject to a non-final Office Action having a notification date of June 3, 2026 (“non-final Office Action”). Following the non-final Office Action, Applicant filed an amendment on August 31, 2026 (the “Amendment”), amending claims 1, 14, 15, 18, and 20; canceling claims 2-4, 16, and 17; and adding new claim 21.
The present Final Office Action addresses pending claims 1, 5-15, and 18-21 in the Amendment.
Response to Arguments
Response to Applicant’s Arguments Regarding Claim Rejections Under 35 USC §112
These rejections are withdrawn in view of the Amendment.
Response to Applicant’s Arguments Regarding Claim Rejections Under 35 USC §102/103
On pages 19-21 of the Amendment, Applicant takes the position that Thng does not disclose "portions of the wearable structure carrying the first electrode and the second electrode have consistent elasticity" as recited in the independent claims. The Examiner disagrees because [0024], [0031], [0032], [0069]-[0070], and [0115] of Thng disclose how the electrodes can be secured to portions of a garment/wearable structure such as an elastic band, where the different portions of the elastic band supporting the electrodes have "consistent" elasticity because they are part of the same elastic band.
Applicant also takes the position that Thng does not disclose "when the human body wears the wearable structure, the first electrode and the second electrode are fitted to anterior superior iliac spine position or posterior superior iliac spine positions on the two sides of a mid-sagittal plane of the human body, respectively," as also recited in the independent claims but instead merely discloses arranging the electrodes "over either hip" or at "pelvic locations." The Examiner disagrees that Thng does not disclose this limitation. As noted in the non-final Office Action and again hereinbelow, the Examiner is interpreting such language to be functional language such that the first and second electrodes are "capable of" being fitted in such positions rather than actually/positively being fitted in such positions to avoid positively claiming the human body and the patent ineligible connotations associated therewith under MPEP 2105(III). In this regard, the Examiner asserts that the positioning of the first and second electrodes at locations over either hip of the user per [0024], [0038]-[0039] of Thng and the flexible/elastic nature of the garment and flexible electric lead per [0031]-[0032], [0038]-[0039], [0069]-[0070], [0115] of Thng would render the first and second electrodes of Thng capable of being fitted to anterior superior iliac spine position or posterior superior iliac spine positions on the two sides of a mid-sagittal plane of the human body.
Response to Applicant’s Arguments Regarding Claim Rejections Under 35 USC §103
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 15 and 18 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The Examiner cannot identify any portion of the original specification providing support for a "heart rate feature extraction processor" or an "analysis processor." For instance, while [0113] discloses how heart rate feature extraction "module" can be configured to extract a heart rate feature and can be integrated into a circuit structure of the wearable device, neither this nor any portion paragraph of the specification appears to provide support for a "heart rate feature extraction processor." Furthermore, while [0114] discloses how analysis "module" can match the heart rate feature with a database of features to obtain a result in one or more manners, neither this nor any portion paragraph of the specification appears to provide support for an "analysis processor."
Claim Rejections - 35 USC § 102
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 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.
Claims 1 and 6-8 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by U.S. Patent App. Pub. No. 2016/0095527 to Thng et al. ("Thng"):
Regarding claim 1, Thng discloses a wearable device (device 300c of Figure 3C and garment of [0069]-[0070] collectively amount to a "wearable device"), comprising:
at least two electrodes configured to fit against a skin of a human body to collect an electrocardiogram (ECG) signal of the human body (first/reference electrode 310c and second/remote electrode 320c fit against the skin and collect ECG signals per [0070]); and
a wearable structure configured to carry the at least two electrodes and fit the at least two electrodes to a waist region of the human body ([0070] discloses how the electrodes can be attached to a housing 330c and flexible substrate 340c which can be fit into a garment; in this regard, the housing 330c and flexible substrate and/or the garment is a "wearable structure"; furthermore [0039] discloses how the first/reference second/remote electrodes can be secured over skin locations located above either hip of the person (waist region)), wherein
the at least two electrodes are spaced apart on the wearable structure (see spacing in Figure 3C; also, [0024], [0047], [0059] discusses spacing),
the at least two electrodes include a first electrode (first/reference electrode 310c) and a second electrode (second/remote electrode 320c), portions of the wearable structure carrying the first electrode and the second electrode have consistent elasticity ([0024], [0031], [0032], [0069]-[0070], [0115] disclose how the electrodes can be secured to portions of a garment/wearable structure such as an elastic band, where the different portions of the elastic band supporting the electrodes have "consistent" elasticity because they are part of the same elastic band), and
when the human body wears the wearable structure (humans wear garments; also see Figure 2),
the first electrode and the second electrode are fitted to anterior superior iliac spine position or posterior superior iliac spine positions on the two sides of a mid-sagittal plane of the human body, respectively (the Examiner is interpreting such language to be functional language such that the first and second electrodes are "capable of" being fitted in such positions rather than actually/positively being fitted in such positions to avoid positively claiming the human body and the patent ineligible connotations associated therewith under MPEP 2105(III); in this regard, the Examiner asserts that the positioning of the first and second electrodes at locations over either hip of the user per [0024], [0038]-[0039] of Thng and the flexible/elastic nature of the garment and flexible electric lead per [0031]-[0032], [0038]-[0039], [0069]-[0070], [0115] of Thng would render the first and second electrodes of Thng capable of being fitted to anterior superior iliac spine position or posterior superior iliac spine positions on the two sides of a mid-sagittal plane of the human body.
Regarding claim 6, Thng discloses the wearable device of claim 1, further including wherein the at least two electrodes protrude from a surface of the wearable structure surrounding the at least two electrodes (Figure 1B illustrates how the electrodes can protrude from a surface of flexible substrate/wearable structure 140).
Regarding claim 7, Thng discloses the wearable device of claim 1, further including wherein the at least two electrodes further include a reference electrode (one of the remote electrodes 321c-324c is a "reference electrode"), the first electrode and the second electrode are spaced apart and disposed on a surface of the wearable structure that is close to the skin of the human body (first/reference electrode 310c and second/remote electrode 320c are spaced apart on a surface of the wearable structure (also, [0024], [0047], [0059] discusses spacing) close to the skin (see skin locations in [0039])), and the reference electrode is disposed between the first electrode and the second electrode (see Figure 3C).
Regarding claim 8, Thng discloses the wearable device of claim 7, further including wherein a dimension of the reference electrode along a second extension direction of the wearable structure is not less than a dimension of the first electrode or the second electrode along the second extension direction of the wearable structure (see Figure 3C).
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 5, 9, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent App. Pub. No. 2016/0095527 to Thng et al. ("Thng") in view of U.S. Patent App. Pub. No. 2010/0185076 to Jeong et al. ("Jeong"):
Regarding claim 5, Thng discloses the wearable device of claim 1, further including wherein the wearable structure has a first extension direction (left-right/horizontal in Figures 2 and 3c) and a second extension direction (up-down/vertical in Figures 2 and 3c) , the second extension direction being perpendicular to the first extension direction (horizontal is perpendicular to vertical), the first electrode and the second electrode are spaced apart along the first extension direction of the wearable structure (see Figure 3c), …
However, Thng appears to be silent regarding a dimension of the first electrode or the second electrode in the first extension direction is in a range of 5 mm ~ 50 mm, and a dimension of the first electrode or the second electrode in the second extension direction is in a range of 5 mm ~ 50 mm.
Nevertheless, Jeong teaches (Figure 1, [0035], [0042]) that it was known in the wearable monitoring art for a physiological signal sensing electrode 120 attached to a garment 110 for measuring ECG signals of a user to have rectangular or circular shape with a diameter in the range of 25-35 mm.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the first and second electrodes of Thng to be for instance circular electrodes with a diameter of 25-35 mm (in a range of 5-50 mm) in the first and second extension directions as Jeong teaches that such electrode dimensions are suitable for obtaining physiological signals in the context of wearable garments, a person of ordinary skill in the art would have been motivated to combine the prior art to achieve the claimed invention, and there would have been a reasonable expectation of success in doing so. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). Furthermore, "where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The courts have made clear that the teaching, suggestion, or motivation test is flexible and an explicit suggestion to combine the prior art is not necessary. The motivation to combine may be implicit and may be found in the knowledge of one of ordinary skill in the art, or, in some cases, from the nature of the problem to be solved. DyStar Textilfarben GmbH & Co. Deutschland KG v. C.H. Patrick Co., 464 F.3d 1356, 1360, 80 USPQ2d 1641, 1645 (Fed. Cir. 2006).
Regarding claim 9, Thng discloses the wearable device of claim 8, but appears to be silent regarding wherein the dimension of the reference electrode along the second extension direction is in a range of 5 mm ~ 80 mm.
Nevertheless, Jeong teaches (Figure 1, [0035], [0042]) that it was known in the wearable monitoring art for a physiological signal sensing electrode 120 attached to a garment 110 for measuring ECG signals of a user to have rectangular or circular shape with a diameter in the range of 25-35 mm.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the dimension of the reference electrode of Thng along the second extension direction to have a diameter of 25-35 mm (range of 5 mm ~ 80 mm) as Jeong teaches that such electrode dimensions are suitable for obtaining physiological signals in the context of wearable garments, a person of ordinary skill in the art would have been motivated to combine the prior art to achieve the claimed invention, and there would have been a reasonable expectation of success in doing so. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). Furthermore, "where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The courts have made clear that the teaching, suggestion, or motivation test is flexible and an explicit suggestion to combine the prior art is not necessary. The motivation to combine may be implicit and may be found in the knowledge of one of ordinary skill in the art, or, in some cases, from the nature of the problem to be solved. DyStar Textilfarben GmbH & Co. Deutschland KG v. C.H. Patrick Co., 464 F.3d 1356, 1360, 80 USPQ2d 1641, 1645 (Fed. Cir. 2006).
Regarding claim 21, the Thng/Jeong combination discloses the wearable device of claim 5, further including wherein material, dimensions in the first extension direction and the second extension direction, and thickness of the first electrode and the second electrode are consistent ([0061] discloses how the first/reference and second/remote electrodes can be composed of the same material; Figures 2 and 3C illustrates how the dimensions in the first and second extension dimensions are the same; and Figure 1B illustrates how the thickness of the first/reference and second/remote electrodes is the same).
Claims 10-13 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent App. Pub. No. 2016/0095527 to Thng et al. ("Thng") in view of U.S. Patent App. Pub. No. 2018/0344171 to Straka et al. ("Straka"):
Regarding claim 10, Thng discloses the wearable device of claim 1, further including a circuit structure configured to process the ECG signal collected by the at least two electrodes (signal conditioner 630/processor 650 of [0070], [0085]-[0101]), …
While Thng discloses how one of the electrodes is connected to the "circuit structure" via lead/wire 648, Thng appears to be silent regarding wherein the circuit structure is disposed on a side of the wearable structure away from the at least two electrodes, and the at least two electrodes are electrically connected to the circuit structure via a wire.
Nevertheless, Straka teaches (Figures 1, 3 and [0015]-[0016], [0022]) that it was known in the wearable monitoring art for a flexible wearable band 10 to include ECG electrodes 12a on an inner surface thereof and a computer device 14 including processor 16, memory 18, etc. (circuit structure) disposed on an opposite outer surface of the band 10 away from the electrodes, where the electrodes 12a are electrically connected to the "circuit structure" via conductive communication pathways/wires 30. This arrangement advantageously maintains contact between the electrodes and the user's skin without inference by the circuit structure while allowing flexibility in positioning of the electrodes on the band, thereby improving device utilization.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the circuit structure to be disposed on a side of the wearable structure away from the at least two electrodes, and the at least two electrodes to be electrically connected to the circuit structure via a wire in the system of Thng as taught by Straka to advantageously maintain contact between the electrodes and the user's skin without inference by the circuit structure while allowing flexibility in positioning of the electrodes on the band, thereby improving device utilization. A person of ordinary skill in the art would have been motivated to combine the prior art to achieve the claimed invention and there would have been a reasonable expectation of success in doing so. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). Furthermore, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. Id.
Regarding claim 11, the Thng/Straka combination discloses the wearable device of claim 10, further including wherein the circuit structure includes a contact impedance measurement circuit configured to obtain contact impedance when the at least two electrodes are fitted to a surface of the skin ([0050] of Thng discloses how the signal conditioner/circuit structure can measure impedance relative to the electrodes).
Regarding claim 12, the Thng/Straka combination discloses the wearable device of claim 10, but appears to be silent regarding a fixing seat, wherein the fixing seat includes a female seat and a sub-seat, the female seat is connected to the wearable structure, the sub-seat is detachably connected to the female seat, and the circuit structure is located within the sub-seat.
Nevertheless, Straka teaches (Figure 3) that it was known in the wearable monitoring art for a wearable device to include a fixing seat including a female seat and a sub-seat, the female seat is connected to the wearable structure, the sub-seat is detachably connected to the female seat, and the circuit structure is located within the sub-seat (see annotated version of Figure 3 below). This arrangement advantageously facilitates attachment of the circuit structure to the wearable device.
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Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the wearable device of the Thng/Straka combination to include a fixing seat, wherein the fixing seat includes a female seat and a sub-seat, the female seat being connected to the wearable structure, the sub-seat being detachably connected to the female seat, and the circuit structure being located within the sub-seat as taught by Straka to advantageously facilitate attachment of the circuit structure to the wearable device. A person of ordinary skill in the art would have been motivated to combine the prior art to achieve the claimed invention and there would have been a reasonable expectation of success in doing so. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). Furthermore, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. Id.
Regarding claim 13, the Thng/Straka combination discloses the wearable device of claim 10, further including a sensor module configured to collect movement data of the human body, the sensor module being communicatively connected to the circuit structure ([0055], [0073], [0100] of Thng discloses accelerometers which would necessarily collect movement of the human body and be communicatively connected to the "circuit structure").
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent App. Pub. No. 2016/0095527 to Thng et al. ("Thng") in view of U.S. Patent No. 4,026,278 to Ricketts et al. ("Ricketts"):
Regarding claim 14, Thng discloses the wearable device of claim 1, further including wherein the wearable structure is an elastic strap-like structure (see Figure 3C; also, [0031], [0032], [0069]-[0070], [0115] disclose how the electrodes can be secured to portions of a garment/wearable structure such as an elastic band), …
However, Thng appears to be silent regarding a first hook and loop patch is provided on a side of the wearable structure in contact with the human body, a second hook and loop patch is provided on a side of each of the at least two electrodes away from a side where the electrode is fitted to the human body, and the each of the at least two electrodes is detachably connected with the wearable structure via the first hook and loop patch and the second hook and loop patch.
Nevertheless, Ricketts teaches (Abstract and claim 1) that it was known in the wearable monitoring art to utilize a Velcro loop fabric (first hook and loop patch) on an inner surface of a belt (side of wearable structure in contact with human body) and a Velcro hook fabric (second hook and loop patch) on the back of electrodes (on side away from where electrode fitted to human body) to provide a convenient manner of detachably connecting the electrodes with the wearable structure.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for a first hook and loop patch to be provided on a side of the wearable structure in contact with the human body and a second hook and loop patch to be provided on a side of each of the at least two electrodes away from a side where the electrode is fitted to the human body in the wearable device of Thng as taught by Ricketts to provide a convenient manner of detachably connecting the electrodes with the wearable structure. A person of ordinary skill in the art would have been motivated to combine the prior art to achieve the claimed invention and there would have been a reasonable expectation of success in doing so. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). Furthermore, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. Id.
Claims 15 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent App. Pub. No. 2016/0095527 to Thng et al. ("Thng") in view of U.S. Patent App. Pub. No. 2004/0127806 to Sweeney et al. ("Sweeney"):
Regarding claim 15, Thng discloses a cardiac monitoring system (device 600 of Figure 6), comprising:
a wearable device configured to acquire an ECG signal of a human body (device 600 can include device 300c which is a device configured to acquire an ECG signal of a human body per [0069]-[0070]);
a heart rate feature extraction processor configured to extract a heart rate feature of the human body based on the ECG signal ([0037], [0045], [0056], [0106] discuss how the program instructions 672 are configured to determine features of the ECG signals such as Q-T intervals, QRS complex parameters, etc. (heart rate features); in this regard, the combination of the processor 650 in Figure 6 and [0088] and the portion of the program instructions 672 configured to determine such features amounts to a "heart rate feature extract processor");
an analysis processor configured to … obtain a heart rate analysis result ([0106] discloses how the determined Q-T intervals, QRS complex parameters, etc. (heart rate features) can be used to determine a health or other state of the user ("heart rate analysis result"); in this regard, the combination of the processor 650 in Figure 6 and [0088] and the portion of the program instructions 672 configured to determine such result amounts to an "analysis processor"); and
a terminal device configured to receive and display the heart rate analysis result ([0113] discloses a processor and user interface (collectively a "terminal device") for displaying alerts regarding the medical condition/state).
The remaining limitations of claim 15 regarding the wearable device are disclosed by Thng as discussed above in relation to claim 1.
However, Thng might be silent regarding the heart rate analysis result specifically being obtained via matching the heart rate feature with a database of heart rate features.
Nevertheless, Sweeney teaches ([0011]) that it was known in the healthcare informatics art to compare an extracted set of cardiac features to a set of identified complexes with known cardiac arrhythmias (where such set of identified complexes with known cardiac arrhythmias would necessarily be stored in some database/data structure) to advantageously facilitate real-time classification of the extracted signals.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the heart rate analysis result of Thng to specifically be obtained via matching the heart rate feature with a database of heart rate features as taught by Sweeney to advantageously facilitate real-time classification of the extracted signals. A person of ordinary skill in the art would have been motivated to combine the prior art to achieve the claimed invention and there would have been a reasonable expectation of success in doing so. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). Furthermore, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. Id.
Regarding claim 18, the Thng/Sweeney combination discloses the cardiac monitoring system of claim 15, further including wherein the terminal device includes a processor (processor 650 in Figure 6 of Thng) and a prompting module ([0113] of Thng discloses generating alerts/messages; in this regard, there is necessarily a set of computer-readable instructions executable by the processor 650 for generating/sending such alerts/messages as that is how computers function), the processor is configured to issue a command based on the heart rate analysis result ([0113] of Thng discloses generating an alert based on the detected medical condition which would necessarily involve triggering or issuing a command to the "prompting module" based on the medical condition (heart rate analysis result) to generate the alert), and control the prompting module to send out a prompting message, make a phone call, or send a message ([0113] of Thng discloses generating an alert).
Claims 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent App. Pub. No. 2016/0095527 to Thng et al. ("Thng") in view of U.S. Patent App. Pub. No. 2021/0121134 to Xia et al. ("Xia"):
Regarding claim 19, Thng discloses a cardiac monitoring system (device 600 of Figure 6), comprising:
a wearable device configured to acquire an ECG signal of a human body (device 600 can include device 300c which is a device configured to acquire an ECG signal of a human body per [0069]-[0070]);
a … model configured to output a heart rate analysis result based on the ECG signal as an input ([0106] discloses how determined Q-T intervals, QRS complex parameters, etc. determined from the ECG signals can be used to determine a health or other state of the user ("heart rate analysis result"); determining the health state/heart rate analysis result based on the features of the ECG signal is necessarily determining such result based on the ECG signal itself because the features are extracted from the ECG signal; furthermore, the set of computer readable instructions configured to perform the aforementioned function is a "model"); and
a terminal device configured to receive and display the heart rate analysis result ([0113] discloses a processor and user interface (collectively a "terminal device") for displaying alerts regarding the medical condition/state).
The remaining limitations of claim 19 regarding the wearable device are disclosed by Thng as discussed above in relation to claim 1.
However, Thng might be silent regarding the model configured to output a heart rate analysis result based on the ECG signal as an input specifically being a trained machine learning model.
Nevertheless, Xia teaches that it was known in the healthcare informatics art to input ECG signal features into a trained model (necessarily a trained ML model as it is trained) to determine a heart disorder of the patient which advantageously increases accuracy of generated predictions by uncovering hidden trends and correlations in the training data as ML is known to do.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the model configured to output a heart rate analysis result based on the ECG signal as an input of Thng to specifically be a trained machine learning model as taught by Xia to advantageously increase accuracy of generated predictions by uncovering hidden trends and correlations in the training data as ML is known to do. A person of ordinary skill in the art would have been motivated to combine the prior art to achieve the claimed invention and there would have been a reasonable expectation of success in doing so. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). Furthermore, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. Id.
Regarding claim 20, the Thng/Xia combination discloses the cardiac monitoring system of claim 19, further including wherein the terminal device includes a processor (processor 650 in Figure 6 of Thng) and a prompting module ([0113] of Thng discloses generating alerts/messages; in this regard, there is necessarily a set of computer-readable instructions executable by the processor 650 for generating/sending such alerts/messages as that is how computers function), the processor is configured to issue a command based on the heart rate analysis result ([0113] of Thng discloses generating an alert based on the detected medical condition which would necessarily involve triggering or issuing a command to the "prompting module" based on the medical condition (heart rate analysis result) to generate the alert), and control the prompting module to send out a prompting message, make a phone call, or send a message ([0113] of Thng discloses generating an alert).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892.
Int'l Pub. No. WO 2017/009878 discloses (Figure 1 and 9:7-11) a wearable structure including one electrode positioned on the left anterior superior iliac spine position and another electrode positioned on the right anterior superior iliac spine position.
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 JONATHON A. SZUMNY whose telephone number is (303) 297-4376. The examiner can normally be reached Monday-Friday 7-5.
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/JONATHON A. SZUMNY/Primary Examiner, Art Unit 3686
