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 are pending in the present application with claims 1, 15, and 19 being independent.
Specification
The use of the term Velcro, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
Claims 1, 15, 18, and 19 are objected to because of the following informalities:
In each of claims 1, 15, and 19, the last two limitations are identical. Therefore, it is recommended that Applicant removes one of such limitations.
As claim 18 depends on itself, the Examiner will assume it depends from independent claim 15.
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: the "heart rate feature extraction module" and "analysis module" in claim 15.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 14 is 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 14 contains the trademark/trade name Velcro. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe patches and, accordingly, the identification/description is indefinite.
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 1-4 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 [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), 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 iliac positions on the two sides of a mid-sagittal plane of the human body, respectively (positioning the first and second electrodes at locations over either hip of the person corresponds to iliac positions on the two sides of a mid-sagittal plane of the human body; furthermore, 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; in this regard, the Examiner asserts that the first and second electrodes are capable of being fitted in the recited positions),
the first electrode and the second electrode are fitted to lower back positions on the two sides of the mid-sagittal plane of the human body, respectively (positioning the first and second electrodes at locations over either hip of the person corresponds to lower back positions on the two sides of the mid-sagittal plane of the human body; furthermore, 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; in this regard, the Examiner asserts that the first and second electrodes are capable of being fitted in the recited positions), or
the first electrode and the second electrode are fitted to lower back positions on the two sides of the mid-sagittal plane of the human body, respectively (positioning the first and second electrodes at locations over either hip of the person corresponds to lower back positions on the two sides of the mid-sagittal plane of the human body; furthermore, 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; in this regard, the Examiner asserts that the first and second electrodes are capable of being fitted in the recited positions).
Regarding claim 2, Thng discloses the wearable device of claim 1, further including wherein when the human body wears the wearable structure, the first electrode and the second electrode are fitted to anterior superior iliac spine positions on the two sides of the mid-sagittal plane of the human body, respectively (positioning the first and second electrodes at locations over either hip of the person corresponds to anterior superior iliac spine positions on the two sides of the mid-sagittal plane of the human body, respectively; furthermore, 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; in this regard, the Examiner asserts that the first and second electrodes are capable of being fitted in the recited positions).
Regarding claim 3, Thng discloses the wearable device of claim 1, further including wherein when the human body wears the wearable structure, the first electrode and the second electrode are fitted to posterior superior iliac spine positions on the two sides of the mid-sagittal plane of the human body, respectively (positioning the first and second electrodes at locations over either hip of the person corresponds to anterior superior iliac spine positions on the two sides of the mid-sagittal plane of the human body, respectively; furthermore, 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; in this regard, the Examiner asserts that the first and second electrodes are capable of being fitted in the recited positions).
Regarding claim 4, Thng discloses the wearable device of claim 1, further including wherein when the human body wears the wearable structure, the first electrode and the second electrode are disposed symmetrically with respect to the mid-sagittal plane of the human body (positioning the first and second electrodes at locations over either hip of the person corresponds to the first and second electrodes being symmetrically disposed relative to the mid-sagittal plane of the human body, respectively; furthermore, 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; in this regard, the Examiner asserts that the first and second electrodes are capable of being fitted in the recited positions).
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 and 9 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 4, 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).
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), …
However, Thng appears to be silent regarding a first Velcro patch is provided on a side of the wearable structure in contact with the human body, a second Velcro 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 Velcro patch and the second Velcro patch.
Nevertheless, Ricketts teaches (Abstract and claim 1) that it was known in the wearable monitoring art to utilize a Velcro loop fabric (first Velcro patch) on an inner surface of a belt (side of wearable structure in contact with human body) and a Velcro hook fabric (second Velcro 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 Velcro patch to be provided on a side of the wearable structure in contact with the human body and a second Velcro 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 15-18 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 module 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 portion of the program instructions configured to determine such features amount to a "heart rate feature extract module");
an analysis module 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")); 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 16, the Thng/Sweeney combination discloses the cardiac monitoring system of claim 15, further including wherein when the human body wears the wearable structure, the first electrode and the second electrode are fitted to anterior superior iliac spine positions on the two sides of the mid-sagittal plane of the human body, respectively (positioning the first and second electrodes at locations over either hip of the person per [0039] of Thng corresponds to anterior superior iliac spine positions on the two sides of the mid-sagittal plane of the human body, respectively; furthermore, 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; in this regard, the Examiner asserts that the first and second electrodes are capable of being fitted in the recited positions).
Regarding claim 17, the Thng/Sweeney combination discloses the cardiac monitoring system of claim 15, further including wherein when the human body wears the wearable structure, the first electrode and the second electrode are fitted to posterior superior iliac spine positions on the two sides of the mid-sagittal plane of the human body, respectively (positioning the first and second electrodes at locations over either hip of the person per [0039] of Thng corresponds to anterior superior iliac spine positions on the two sides of the mid-sagittal plane of the human body, respectively; furthermore, 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; in this regard, the Examiner asserts that the first and second electrodes are capable of being fitted in the recited positions).
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. The references cited on the attached PTO-892 disclose various wearable garments/straps/belts that incorporate electrodes for measuring ECG data of a user, extracting heart related features, and determining analytical results.
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/JONATHON A. SZUMNY/Primary Examiner, Art Unit 3686
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