DETAILED ACTION
This Office action is responsive to communications filed on 01/19/2026. Claim 1 and 15 has been amended. Claims 3, 7, & 11-12 are canceled. Claim 14 is withdrawn. Presently, Claims 1-2, 4-6, 8-10, 13, and 15-18 remain pending and are hereinafter examined on the merits.
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 .
Response to Arguments
Applicant’s arguments with respect to claim(s) have been considered but are moot because the new ground of rejection does not rely on Gehman et al (US 2008/0214901 A1) in view of Lian et al (US 2013/0116533 A1) in view of in view of Kumar et al (US 20190021671 A1) for Claims 1-2, 4-6, 8, 13, and 17 and/or on Gehman et al (US 2008/0214901 A1) in view of Lian et al (US 2013/0116533 A1) in view of Kumar et al (US 20190021671 A1) in view of Arne et al (US 2014/0051946 A1) for Claims 15-16, and 18 applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
The new grounds of rejection for Claims 1-2, 4-6, 8, 13, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Gehman et al (US 2008/0214901 A1) in view of Lian et al (US 2013/0116533 A1) in view of Bernstein et al (US 2011/0213225 A1).
The new grounds of rejection for Claims 15-16, and 18 Gehman et al (US 2008/0214901 A1) in view of Lian et al (US 2013/0116533 A1) in view of Bernstein et al (US 2011/0213225 A1) in view of Arne et al (US 2014/0051946 A1).
Applicant's arguments filed 01/19/2026 have been fully considered with respect to Gehman et al and Lian et al, but they are not persuasive.
Applicant asserts that neither Gheman nor Lian discloses a second skin-facing surface that entirely covers the top surface of the electronics module. This argument is not persuasive in view of Gehman’s express teachings that the adhesive membrane covers the electronics module as part of the assembly. As noted in the prior Office Action, Gehman discloses, the structural features of a wearable sensor base structure having a first and second skin facing surface. Gehman herein additionally discloses, the newly claimed recitation of: “wherein the second skin facing surface of the base structure covers the entire top surface of the electronics module”
Gehman explicitly discloses: (¶Abstract, ‘The plurality of electrodes and the electronics module are covered by a single adhesive membrane (20) that enables the wearable device to adhere to the surface of the body.”; Claim 1, “wherein said plurality of electrodes and said electronics module are covered by a single adhesive membrane to enable said wearable device to adhere to the surface of the body.”)
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Here below is a side-by-side comparison of Gehman structure compared to the Applicant’s structure, both of which are substantially identical,
The claim does not require direct physical contact without any intervening material, nor does it preclude spacing. Hence, the Applicant’s arguments appears to import a narrower interpretation of “covers” than is supported by the claim language.
With respect to the conductive tracks, the Applicant argues the Gehman does not disclose conductive tracks extending along first and second-facing surfaces of an inclined surface, and that Lian discloses only side-surface ports, allegedly being incompatible with a top surface arrangement. As stated in the previous Office Action filed on 10/22/2025, this argument mischaracterizes the basis of the rejection.
Lian, by contrast, is relied upon for teaching the electrical interconnections and contact interface between conductive tracks with respect to an electronics module. Specifically, Lian teaches wires 130 connecting electrodes 120 to electrically conducting terminals 140, which in turn contact electrically conducting ports 210 on the top surface of the controller 200. The Examiner maintains that these conductive elements of Lian correspond to the claimed “electrically conductive tracks comprises contact terminals in contact with corresponding contact terminals on the top surface of the electronics module”.
The Applicant argues that Lian does not show a “top surface” consistent with the specification definition.
This assertion that Lian’s electronics module is configured with ports on a side surface, not on a top surface as claimed, is an incorrect interpretation of the prior art in view of the Applicant’s specification and under the broadest reasonable interpretation and it contradicts the Applicant’s specification of what constitutes as a “top surface”.
- Applicant’s specification recites at ¶0008: “a bottom side, a bottom surface, a bottom portion etc. may refer to a side, a surface or a portion of the wearable sensor device, or a side, a surface or a portion of any of its components, facing toward the skin surface of the subject when the wearable sensor device is arranged thereto. Likewise, a top side, a top surface, a top portion etc. may refer to a side, a surface, a portion of the wearable sensor device, or a side, a surface, or a portion of any of its components, facing away from the skin of a subject when the wearable sensor device is arranged thereto.”.
-By definition of the Applicant’s specification admits, the “top surface” can be interpreted as a “side” or “portion” of the device, provided it meets the orientation requirement of facing away from the skin. Neither the claims, nor the specification preclude the interpretation that a part or portion of a top surface/side/portion faces away from the skin. Accordingly, the interpretation of the specification and the claims is consistent with the broadest reasonable interpretation (i.e., the Examiner interpretation) in that the top surface of Lian refers to a side or portion of the device, which the corresponding contact terminals, (ports 210) of the electronics module (electronics controller 200), in FIG. 1A-4, and the contact terminals (electrical conducting terminals 140) of the electrically conductive tracks (wires 130), FIG. 1A-4, are on the “side” or “portion” of the electronics module (electronics controller 200); in addition to at least portions of the corresponding contact terminals ((ports 210), and the contact terminals (electrical conducting terminals 140) are facing away from the skin, FIG. 3A, as interpreted in view of the broadest reasonable interpretation and in view of the Applicants specification. Note; the goal of Lian is to achieve disposable unit configured to be adhered to a patient’s skin, ¶0013.
In other words, Applicant contends that Lian’s terminals are disposed on a “side wall” and therefore cannot correspond to the claimed top surface. First, as noted above, the Applicant’s own specification defines “top surface” broadly as a surface side, or portion facing away from the skin. Claim 1, even as amended, defines the top surface functionally by its orientation relative to the skin and its contact and the second skin facing surface of the base structure. To an extent Lian’s ports are located on a portion of the electronics module that faces away from the skin and interfaces with the overlying structure, this reasonably meets the claimed orientation under the broadest reasonable interpretation.
More specifically, Gehman is relied upon for the base structure, including the inclined surface, represented in FIG. 1, and the arrangement of the electronics module with a top surface facing away from the skin. Lian is relied upon for teaching electrically conductive tracks (wires 130) extending along a flexible base structure from electrodes to an electronics module and for teaching contact terminals and corresponding ports. The rejection does not rely on Lian to teach the inclined surface or Gehman to teach the routing of the tracks along multiple surfaces. Rather the combination teaches that it was known to route flexible conductive tracks along a flexible skin adhering base to contact terminals on an electronics module.
The Applicant’s arguments regarding Lian for failing to disclose a top-surface arrangement as defined in claim 1, overlooks that Gehman already teaches an electronics module with conductive pads on its top surface. The rejection relies on Gehman for the top surface contact arrangement and on Lian for the use of flexible conductive tracks and corresponding terminals. Hence, the Applicant’s arguments the Lian along does not disclose the top-surface terminal is therefore directed to a limitation for which Lian was not solely relied upon.
The Applicant’s further assertions that implementing Lian’s track arrangement into Gehman would require substantial redesign and relocation of terminals from a top surface to side surface. This argument is based on the premise that the proposed modification would require a wholesale adoption of the Lian’s specific structural configuration, and thus is conclusory. The rejection proposes incorporating Lian’s known use of flexible conductive tracks with contact terminals into Gehman devices, which already includes top surface conductive pads. Modifying Gehman to employ conductive tracks routed along its base structure to those top surface pads constitutes as a predictable use of known elements performing their established function. There no relocation of Gehman top surface pas is required by the combination as articulated.
Applicant re-states the Lian’s flexibility is disclosed only in the context of conforming to a non-flat surface and does not enable multiple surface routing towards a top surface. However, as noted in the Office Action, Lian expressly teaches that the wires and terminals are enclosed within a flexible, biocompatible polymer housing configured to adhere to skin. A person of ordinary skill in the art would have understood that such flexible conductive tracks may be routed along the contours of a base structure, including transitions between surfaces, particular where Gehman already provides an inclined surface joining two skin facing surfaces.
Therefore, the rejections under 35 USC § 103 are maintained.
Examiners Notes
The Applicant’s specification recites at ¶0008: “a bottom side, a bottom surface, a bottom portion etc. may refer to a side, a surface or a portion of the wearable sensor device, or a side, a surface or a portion of any of its components, facing toward the skin surface of the subject when the wearable sensor device is arranged thereto. Likewise, a top side, a top surface, a top portion etc. may refer to a side, a surface, a portion of the wearable sensor device, or a side, a surface, or a portion of any of its components, facing away from the skin of a subject when the wearable sensor device is arranged thereto.”.
-By definition of the Applicant’s specification admits, the “top surface” can be broadly interpreted as a “side” or “portion” of the wearable sensor device, provided it meets the orientation requirement of facing away from the skin.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-2, 4-6, 8-10, 13, and 15-18 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth 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 1, “the entire top surface”. There is insufficient antecedent basis for this limitation in the claim, as required by MPEP 2173.05(e). For examination purposes, the Examiner assumes a major part of the top surface consistent with the specification. Accordingly, proper antecedent basis is required.
The above rejections to claim 1 apply to claim 15 for substantially identical claim
limitations recited in the claim. Appropriate correction is required.
The dependent claims of the above rejected claims are rejected due to their dependency.
Claim Objections
The following claims are objected to because of the following informalities and should recite:
Claim 1 & 15, “.5 centimeters (cm) and 2 cm”. Appropriate correction is needed.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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 1-2, 4-6, 8, 13, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Gehman et al (US 2008/0214901 A1) in view of Lian et al (US 2013/0116533 A1) in view of Bernstein et al (US 2011/0213225 A1).
Claim 1: Gehman discloses, A wearable sensor device configured for arrangement to a skin surface (30) of a subject, comprising (¶Abstract, ‘A wearable compact, lightweight, noninvasive, wearable “unified” device or system (10)’; ¶0022, ‘The elements of the system 10, shown as applied to a person's skin 30, are contained within (or covered by) an adhesive membrane 20, and include an electronics module 12’)
a base structure (adhesive membrane 20) of the wearable sensor device is configured to be arranged to contact the skin surface of the subject, which provides a first skin facing surface and a second skin facing surface distal to the skin surface of the subject, wherein the first skin facing surface is located closer to the skin surface of the subject than the second skin facing surface when the wearable sensor device is arranged to contact the skin surface of the subject, (FIG. 1, ¶0022, ‘A perspective view of a wearable monitoring system 10 in accordance with the present invention is shown in FIG. 1. The elements of the system 10, shown as applied to a person's skin 30, are contained within (or covered by) an adhesive membrane 20’)
-Refer to FIG. 1 of Gehman below which provides a first and second skin facing surfaces distal to the skin surface of the subject, wherein the first skin facing surface is located closer to the skin surface of the subject than the second skin facing surface when the wearable sensor device is arranged to contact the skin surface of the subject, as required by the claim.
wherein the base structure further comprises an inclined surface at least partly joining the first skin facing surface and the second skin facing surface;
-Gehman further discloses wherein the base structure (adhesive member 20) further comprises an inclined surface at least partly joining the first skin facing surface and the second skin facing surface, refer to FIG. 1 below.
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Here below is a side-by-side comparison of Gehman structure compared to the Applicant’s structure, both of which are substantially identical,
one or more electrodes (electrodes 14, FIG. 1. ¶Abstract, ‘The system includes at least one pair of sense electrodes (14)’) arranged on the first skin facing surface of the base structure (refer to FIG. 1, the one or more electrodes 14 are arranged on the first skin facing surface of the base structure, as required by the claim) and configured to provide an electrical signal containing information of the subject; (¶0010, ‘The device includes a plurality of electrodes, including at least one pair of sense electrodes and a reference electrode, each configured to be adhesively attached to a surface of the body. An electronics module of the device is in electrical communication with each of the electrodes, includes a power source, and processes and analyzes signals provided by the electrodes. In accordance with the invention, the plurality of electrodes and the electronics module are covered by a single adhesive membrane which enables the wearable device to adhere to the surface of the body.’; ¶0026, ‘The electronics module 12 receives a signal from the sense electrodes 14 used to monitor at least one physiological condition and processes and analyzes the output.’)
an electronics module (electronics module 12) configured to process the electrical signal provided by the one or more electrodes, (¶0010, the electronics module is in electrical communication with each of the electrodes and includes a power source.) the electronics module having a bottom surface and a top surface and a height between the bottom and top surfaces (FIG. 1. The electronics module has a bottom surface and a top surface and a height between the bottom and top surfaces, as required by the claim), the electronics module comprising a printed circuit board, (¶0029, ‘the electronics module 12 may be mounted on flexible circuitry, for example, with a circuit area of about 1 inch by 2 inches (2.5 by 5 cm), or on multiple rigid circuitry pieces with flexible interconnections’) sensory electronics (¶0011, ‘the electronics module includes a wireless transmitter and, upon detection by the electronics module of a predetermined condition, the wireless transmitter transmits an alarm status.’), and a battery (Claim 3, ‘wherein said electronics module includes a battery.’),
the bottom surface being in contact with the skin surface of the subject when the wearable sensor device is arranged thereto (FIG. 1, ¶0022, ‘The elements of the system 10, shown as applied to a person's skin 30’; the electronics module is arranged with the bottom surface being in contact with the skin of the subject when the wearable sensor device is arranged thereto, as required by the claim. The claim does not specify how the electronics module is arranged with the bottom surface being in contact with the skin surface.) and with the top surface being in contact with the second skin facing surface of the base structure (FIG. 1 the top surface of the electronics module is in contact with the second skin face surface of the base structure, as required by the claim.), wherein the second skin facing surface of the base structure covers the entire top surface of the electronics module; (FIG. 1)
-Gehman explicitly teaches, “the adhesive membrane” (20), covers the entire assembly which includes the electronics module, see below: Hence, the second skin facing surface of the base structure covers the entire (interpreted as a major part in view of the broadest reasonable interpretation under 35 USC § 112(b)) top surface of the electronics module, as required by the claim. Note; the claim does not further specify how the second skin facing surface of the base structure “covers” the entire top surface of the electronics module. The claim does not preclude an interpretation that space can exist between the second skin facing surface of the base structure and the top surface of the electronics module.
Accordingly, Gehman explicitly discloses: (¶Abstract, ‘The plurality of electrodes and the electronics module are covered by a single adhesive membrane (20) that enables the wearable device to adhere to the surface of the body.”; Claim 1, “wherein said plurality of electrodes and said electronics module are covered by a single adhesive membrane to enable said wearable device to adhere to the surface of the body.”)
corresponding contact terminals on the top surface of the electronics module, (¶0013, ‘The electronics module may also have a plurality of conductive pads formed on its top and bottom surfaces’; ¶0022, ‘an electronics module 12 (that includes two silver plated conductive pads 13 on its top surface), at least two sense electrodes 14,’)
wherein said one or more electrodes and the electronics module are arranged on a same side of the base structure (FIG. 1, the one or more electrodes and the electronics module arranged to face the skin on the same side of the base structure. That is, the base structure covers both the one or more electrodes and the electronics module such that each are arranged on the same side.) and
wherein when the wearable sensor device is arranged to contact the skin surface of the subject, said one or more electrodes and the electronics module are arranged in-between the skin surface of the subject and the base structure (FIG. 1).
Gehman fails to disclose: electrically conductive tracks electrically connecting said one or more electrodes to the electronics module, wherein the electrically conductive tracks extend along the first and second skin facing surfaces, wherein the electrically conductive tracks comprise contact terminals in contact with corresponding contact terminals on the top surface of the electronics module,
However, Lian in the context of electronic components attached to the skin of a patient, discloses, electrically conductive tracks (wires 130, FIG. 4) electrically connecting said one or more electrodes (electrodes 120) to the electronics module (electronics controller 200, Fig. 4), wherein the electrically conductive tracks extend along the first and second skin facing surfaces (FIG. 4, the electrically conductive tracks extend along the first and second skin facing surfaces.), wherein the electrically conductive tracks comprise contact terminals (electrical conducting terminals 140, FIG. 4, ¶0044, ‘The electrodes 120 are connected to the respective electrical conducting terminals 140 via the conducting wires 130’) in contact with corresponding contact terminals (electrical conducting ports 210, ¶0044, ‘Both conducting wires 130 and the electrical conducting terminals 140 are enclosed inside the disposable unit 100 which has a watertight housing that is made of a flexible biocompatible polymer.’; ¶0047, ‘The electrical conducting ports 210 on the surface of the electronic controller 200 make secure contact with the respective electrical conducting terminals 140’) on the top surface of the electronics module (FIG. 4, the electrical conducting ports 210 are on a top surface of the electronics module of Lian.),
-Note; the Applicant’s specification recites at ¶0008: “a bottom side, a bottom surface, a bottom portion etc. may refer to a side, a surface or a portion of the wearable sensor device, or a side, a surface or a portion of any of its components, facing toward the skin surface of the subject when the wearable sensor device is arranged thereto. Likewise, a top side, a top surface, a top portion etc. may refer to a side, a surface, a portion of the wearable sensor device, or a side, a surface, or a portion of any of its components, facing away from the skin of a subject when the wearable sensor device is arranged thereto.”.
-By definition of the Applicant’s specification, the “top surface” can be interpreted as a “side” or “portion” of the device, provided it meets the orientation requirement of facing away from the skin. Neither the claims, nor the specification preclude the interpretation that a part or portion of a top surface/side/portion faces away from the skin. Accordingly, the interpretation of the specification and the claims is consistent with the broadest reasonable interpretation (i.e., the Examiner interpretation) in that the top surface of Lian refers to a side or portion of the device, which the corresponding contact terminals, (ports 210) of the electronics module (electronics controller 200), in FIG. 1A-4, and the contact terminals (electrical conducting terminals 140) of the electrically conductive tracks (wires 130), FIG. 1A-4, are on the “side” or “portion” of the electronics module (electronics controller 200); in addition to at least portions of the corresponding contact terminals ((ports 210), and the contact terminals (electrical conducting terminals 140) are facing away from the skin, FIG. 3A, as interpreted in view of the broadest reasonable interpretation and in view of the Applicants specification. Note; the goal of Lian is to achieve disposable unit configured to be adhered to a patient’s skin, ¶0013.
-Lian provides contextual evidence regarding the nature of the components surrounding and containing the wires 130, which implies flexibility, integral to the design. The conducting wires 130 connect the electrodes 120 to the electrical conducting terminals, ¶0044. The conducting wries 130, along the electrical conducting terminals 140, are enclosed inside the disposable unit 100, ¶0044. Crucially, the disposable unit has a watertight housing that is made of a flexible biocompatible polymer, ¶0044, ‘Both conducting wires 130 and the electrical conducting terminals 140 are enclosed inside the disposable unit 100 which has a watertight housing that is made of a flexible biocompatible polymer.’. The disposable unit is configured to be adhered to the patient’s skin and includes a substantially flat and flexible skin contacting portions, ¶0013. The watertight chamber (which accommodates the electronic controller 200) is attached to or integrated within this flat and flexible skin contacting portion, ¶0016-0017. Hence, the wires 130 would be flexible such that the goal of achieving flexible design is accomplished.
Note; Gehman is relied upon to teach the inclined surface, see FIG. 4 highlighted above.
Note; Lian teaches wires 130 (i.e., electrically conductive tracks) as being flexible, see ¶0013, ¶0016-0017, ¶0044, supported by the context and design requirement.
Therefore, it would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the device of Gehman such that it includes electrically conductive tracks electrically connecting said one or more electrodes to the electronics module, wherein the electrically conductive tracks extend along the first and second skin facing surfaces, and to include the electrically conductive tracks to comprise contact terminals in contact with corresponding contact terminals on the top surface of the electronics module as taught by Lian for the advantage of providing an improved apparatus with such an apparatus being able to electrically connect the respective electrodes, as suggested by ¶0047 of Lian.
The modified combination would disclose: wherein the electrically conductive tracks (of Lian) extend along the first and second skin facing surfaces and along the inclined surface (of Gehman)
Gehman fails to disclose the specific dimensions of the electronics module having a height defining a distance between the bottom and top surfaces of between 0.5 cm and 2 cm. (i.e., wherein the electronics module has a height defining a distance between the bottom and top surfaces of between 0.5 cm and 2 cm), as required by the claim.
However, Bernstein in the context of medical devices (i.e., adhesive patches) for attachment on a skin surface on the body of a user includes an electronics 110 (i.e., an electronics module), discloses, wherein the electronics module has a height defining a distance between the bottom and top surfaces of between 0.5 cm and 2 cm (¶0111, ‘Referring to FIGS. 2A-2B, on body electronics 110 in certain embodiments is sized and shaped such that the height or thickness profile is minimized (for example, to less than or equal to about 10 mm, e.g., or less than or equal to about 7 mm, e.g., or less than or equal to about 5 mm, e.g., or less than or equal to about 4.5 mm, e.g., or less than or equal to about 4 mm or less).’)
-Less than or equal to about 10 mm equates to (1 cm).
-Less than or equal to about 7 mm equates to (0.7 cm).
-Less than or equal to about 5 mm equates to (0.5 cm).
Therefore, Bernstein teaches, “explicitly discloses” wherein the electronics module (body electronics 110) has a height defining a distance between the bottom and top surfaces of between 0.5 cm and 2 cm.
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the height of the electronics module of modified Gehman such that it is a height of 1 cm or 0.7 cm or 0.5 cm as taught by Bernstein. The motivation to do this yield predictable results such as minimizing the height profile of the electronics module to optimize the device for reduction, thereby maximizing comfort for the user during use and wear, as suggested by Bernstein, ¶0111, ¶0115.
Claim 2: Modified Gehman discloses all the elements above in claim 1, Gehman discloses, wherein the first skin facing surface is adapted to extend at least partly along a circumference of the second skin facing surface (FIG. 1, the first skin facing surface extends at least partly along a circumference of the second skin facing surface. The claim does not require how the first skin facing surface is adapted to extend at least partly along a circumference of the second skin facing surface. The claim does not specify the size, shape, or location of the surfaces.).
Claim 4: Modified Gehman discloses all the elements above in claim 1, Gehman discloses, wherein the base structure comprises a flexible material. (¶0016, ‘The electrodes and the processor are mounted together within the confines of a single flexible adhesive material adapted to be adhered to the human body, such that the electrodes and processor avoid interfering with the motion and flexibility of the human body.’; ¶0030, ‘The entire assembly is covered by the adhesive membrane 20, which may be a flexible, waterproof, breathable, and/or biocompatible adhesive membrane to aid in adhering it to the body 30.’)
Claim 5: Modified Gehman discloses all the elements above in claim 1, Gehman discloses, wherein the base structure comprises two or more first skin facing surface portions, wherein at least one electrode of said one or more electrodes is arranged on each of the two or more first skin facing surface portions (FIG. 1, the base structure of Gehman would disclose two or more first skin surface portions which equates to regions where the respective electrodes lies. Such that at least one electrode of said one or more electrodes is arranged on each of the two or more first skin facing surfaces. The term “portion” is broadly recited and does not specify the size, shape, or location.).
Claim 6: Modified Gehman discloses all the elements above in claim 5, Gehman discloses, wherein said one or more electrodes comprises at least two electrodes arranged on a single first skin facing surface portion (FIG. 1, said one or more electrodes are the two electrodes (14), which are arranged on a single first skin facing surface portion. The term “portion” is broadly recited and does not specify the size, shape, or location.).
Claim 8: Modified Gehman discloses all the elements above in claim 1, Gehman fails to disclose: discloses, wherein the electronics module is arranged on the contact terminals of the electrically conductive tracks.
However, Lian is relied upon above discloses: wherein the electronics module (electronic controller 200) is arranged on the contact terminals of the electrically conductive tracks (FIG. 4, ¶0047, ‘The electrical conducting ports 210 on the surface of the electronic controller 200 make secure contact with the respective electrical conducting terminals 140’)
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the electronics modules of modified Gehman such that it is arranged on the contact terminals of the electrically conductive tracks, as taught by Lian for the advantage of providing an improved apparatus with such an apparatus being able to electrically connect the respective electrodes, as suggested by Lian ¶0047.
Claim 13: Modified Gheman discloses all the elements above in claim 1, Gehman discloses, wherein the wearable sensor device is adapted to be fixed to a skin surface using an adhesive (Abstract, ‘The system includes at least one pair of sense electrodes (14) and one reference electrode (16), each configured to be adhesively attached to a surface of the body (30).’).
Claim 17: Modified Gheman discloses all the elements above in claim 1, Gehman discloses, wherein an elevation distance between the first and second skin facing surfaces, joined by the inclined surface, corresponds to the height of the electronics module.
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Here below is a side-by-side comparison of Gehman structure compared to the Applicant’s structure, both of which are substantially identical,
-The elevation distance between identified first and second skin facing surfaces, are joined by the inclined surface, corresponding to the height of the electronics model (12) of Gehman, see the side-by-side comparison above.
Claims 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Claims 1-6, 8, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Gehman et al (US 2008/0214901 A1) in view of Lian et al (US 2013/0116533 A1) in view of Bernstein et al (US 2011/0213225 A1), as applied to claim 1 above, in further view of Trapero Martin et al (US 2021/0228134 A1).
Claim 9: Modified Gehman discloses all the elements above in claim 1, Gehman fails to disclose: wherein the electronics module comprises one or more sensors configured to face the skin surface of the subject when the wearable sensor device is arranged thereto.
However, Trapero Martin in the context of wearable sensor devices discloses, wherein the electronics module comprises one or more sensors configured to face the skin surface of the subject when the wearable sensor device is arranged thereto. [0073], ‘an optical sensor can be coupled to a PCB, such as by being soldered to the PCB, and the base can include an opening that optically exposes the optical sensor to the skin of the user when the PCB is installed in the electronics module and the smart patch is worn by a user’. Refer to FIG. 2 of Trapero Martin wherein the optical sensor 236 is arranged such that it faces the skin surface when the wearable sensor device is arranged.
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the electronics module of modified Gehman to comprises sensors as taught by Trapero Martin. The motivation to do this would be to obtain PPG singals of the subject to detect the heart rate of the subject, as suggested by Trapero Martin [0074].
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the sensor of modified Gehman such that it is arranged to face the skin of the surface when the wearable sensor device is arranged thereto as taught by Trapero Martin. The motivation to do this yields predictable results such as improving the access of the skin to detect the heart rate of the user and/or blood oxygenation of the user among other health metrics, as suggested by Trapero Martin [0074].
Claim 10: Modified Gehman discloses all the elements above in claim 9, Gehman fails to disclose, wherein at least one of the one or more sensors is an optical sensor.
However, Trapero Martin is relied upon above discloses, wherein at least one of the one or more sensors is an optical sensor. [0073], ‘an optical sensor can be coupled to a PCB, such as by being soldered to the PCB, and the base can include an opening that optically exposes the optical sensor to the skin of the user when the PCB is installed in the electronics module and the smart patch is worn by a user’. Refer to FIG. 2 of Trapero Martin wherein the optical sensor 236 is arranged such that it faces the skin surface when the wearable sensor device is arranged.
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the sensor of modified Gehman such that it is an optical sensor as taught by Trapero Martin. The motivation to do this would be to obtain PPG singals of the subject to detect the heart rate of the subject, as suggested by Trapero Martin [0074].
Claims 15-16, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Gehman et al (US 2008/0214901 A1) in view of Lian et al (US 2013/0116533 A1) in view of Bernstein et al (US 2011/0213225 A1) in view of Arne et al (US 2014/0051946 A1).
Claim 15: Gehman discloses, A method of measuring a bio-impedance signal of a subject, comprising: (¶Abstract, ‘A wearable compact, lightweight, noninvasive, wearable “unified” device or system (10)’; ¶0022, ‘The elements of the system 10, shown as applied to a person's skin 30, are contained within (or covered by) an adhesive membrane 20, and include an electronics module 12’; ¶0026, ‘The electronics module 12 receives a signal from the sense electrodes 14 used to monitor at least one physiological condition and processes and analyzes the output.’)
providing a wearable sensor device for arrangement to a skin surface of the subject, (¶Abstract, ‘A wearable compact, lightweight, noninvasive, wearable “unified” device or system (10)’) wherein the wearable sensor device comprises:
a base structure (adhesive membrane 20) of the wearable sensor device is configured to be arranged to contact the skin surface of the subject, which provides a first skin facing surface and a second skin facing surface distal to the skin surface of the subject, wherein the first skin facing surface is located closer to the skin surface than the second skin facing surface when the wearable sensor device is arranged to contact the skin surface of the subject; (FIG. 1, ¶0022, ‘A perspective view of a wearable monitoring system 10 in accordance with the present invention is shown in FIG. 1. The elements of the system 10, shown as applied to a person's skin 30, are contained within (or covered by) an adhesive membrane 20’)
-Refer to FIG. 1 of Gehman below which provides a first and second skin facing surfaces distal to the skin surface of the subject, wherein the first skin facing surface is located closer to the skin surface of the subject than the second skin facing surface when the wearable sensor device is arranged to contact the skin surface of the subject, as required by the claim.
wherein the base structure further comprises an inclined surface at least partly joining the first skin facing surface and the second skin facing surface;
-Gehman further discloses wherein the base structure (adhesive member 20) further comprises an inclined surface at least partly joining the first skin facing surface and the second skin facing surface, refer to FIG. 1 below.
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Here below is a side-by-side comparison of Gehman structure compared to the Applicant’s structure, both of which are substantially identical,
one or more electrodes (electrodes 14, FIG. 1. ¶Abstract, ‘The system includes at least one pair of sense electrodes (14)’) arranged on the first skin facing surface of the base structure (refer to FIG. 1, the one or more electrodes 14 are arranged on the first skin facing surface of the base structure, as required by the claim) and configured to provide an electrical signal containing information of the subject; (¶0010, ‘The device includes a plurality of electrodes, including at least one pair of sense electrodes and a reference electrode, each configured to be adhesively attached to a surface of the body. An electronics module of the device is in electrical communication with each of the electrodes, includes a power source, and processes and analyzes signals provided by the electrodes. In accordance with the invention, the plurality of electrodes and the electronics module are covered by a single adhesive membrane which enables the wearable device to adhere to the surface of the body.’; ¶0026, ‘The electronics module 12 receives a signal from the sense electrodes 14 used to monitor at least one physiological condition and processes and analyzes the output.’)
an electronics module (electronics module 12) configured to process the electrical signal provided by the one or more electrodes, (¶0010, the electronics module is in electrical communication with each of the electrodes and includes a power source.) the electronics module having a bottom surface and a top surface and a height between the bottom and top surfaces, (FIG. 1. The electronics module has a bottom surface and a top surface and a height between the bottom and top surfaces, as required by the claim) the electronics module comprising a printed circuit board, (¶0029, ‘the electronics module 12 may be mounted on flexible circuitry, for example, with a circuit area of about 1 inch by 2 inches (2.5 by 5 cm), or on multiple rigid circuitry pieces with flexible interconnections’) sensory electronics, (¶0011, ‘the electronics module includes a wireless transmitter and, upon detection by the electronics module of a predetermined condition, the wireless transmitter transmits an alarm status.’) and a battery (Claim 3, ‘wherein said electronics module includes a battery.’),
the bottom surface being in contact with the skin surface of the subject when the wearable sensor device is arranged thereto (FIG. 1, ¶0022, ‘The elements of the system 10, shown as applied to a person's skin 30’; the electronics module is arranged with the bottom surface being in contact with the skin of the subject when the wearable sensor device is arranged thereto, as required by the claim. The claim does not specify how the electronics module is arranged with the bottom surface being in contact with the skin surface.) and with the top surface being in contact with the second skin facing surface of the base structure; (FIG. 1 the top surface of the electronics module is in contact with the second skin face surface of the base structure, as required by the claim.), wherein the second skin facing surface of the base structure covers the entire top surface of the electronics module; (FIG. 1)
-Gehman explicitly teaches, “the adhesive membrane” (20), covers the entire assembly which includes the electronics module, see below: Hence, the second skin facing surface of the base structure covers the entire (interpreted as a major part in view of the broadest reasonable interpretation under 35 USC § 112(b)) top surface of the electronics module, as required by the claim. Note; the claim does not further specify how the second skin facing surface of the base structure “covers” the entire top surface of the electronics module. The claim does not preclude an interpretation that space can exist between the second skin facing surface of the base structure and the top surface of the electronics module.
Accordingly, Gehman explicitly discloses: (¶Abstract, ‘The plurality of electrodes and the electronics module are covered by a single adhesive membrane (20) that enables the wearable device to adhere to the surface of the body.”; Claim 1, “wherein said plurality of electrodes and said electronics module are covered by a single adhesive membrane to enable said wearable device to adhere to the surface of the body.”)
corresponding contact terminals on the top surface of the electronics module, (¶0013, ‘The electronics module may also have a plurality of conductive pads formed on its top and bottom surfaces’; ¶0022, ‘an electronics module 12 (that includes two silver plated conductive pads 13 on its top surface), at least two sense electrodes 14,’)
wherein said one or more electrodes and the electronics module are arranged on a same side of the base structure, (FIG. 1, the one or more electrodes and the electronics module arranged to face the skin on the same side of the base structure. That is, the base structure covers both the one or more electrodes and the electronics module such that each are arranged on the same side.) and
wherein when the wearable sensor device is arranged to contact the skin surface of the subject, said one or more electrodes and the electronics module are arranged in-between the skin surface of the subject and the base structure, applying the wearable sensor device the skin surface of the subject (FIG. 1),
Gehman fails to disclose: electrically conductive tracks electrically connecting said one or more electrodes to the electronics module, wherein the electrically conductive tracks extend along the first and second skin facing surfaces, wherein the electrically conductive tracks comprise contact terminals in contact with corresponding contact terminals on the top surface of the electronics module,
However, Lian in the context of electronic components attached to the skin of a patient, discloses, electrically conductive tracks (wires 130, FIG. 4) electrically connecting said one or more electrodes (electrodes 120) to the electronics module (electronics controller 200), wherein the electrically conductive tracks extend along the first and second skin facing surfaces (FIG. 4, the electrically conductive tracks extend along the first and second skin facing surfaces.), wherein the electrically conductive tracks comprise contact terminals (electrical conducting terminals 140, FIG. 4, ¶0044, ‘The electrodes 120 are connected to the respective electrical conducting terminals 140 via the conducting wires 130’) in contact with corresponding contact terminals (electrical conducting ports 210, ¶0047, ‘The electrical conducting ports 210 on the surface of the electronic controller 200 make secure contact with the respective electrical conducting terminals 140’) on the top surface of the electronics module (FIG. 4, the electrical conducting ports 210 are on the top surface of the electronics module of Lian.),
-Note; the Applicant’s specification recites at ¶0008: “a bottom side, a bottom surface, a bottom portion etc. may refer to a side, a surface or a portion of the wearable sensor device, or a side, a surface or a portion of any of its components, facing toward the skin surface of the subject when the wearable sensor device is arranged thereto. Likewise, a top side, a top surface, a top portion etc. may refer to a side, a surface, a portion of the wearable sensor device, or a side, a surface, or a portion of any of its components, facing away from the skin of a subject when the wearable sensor device is arranged thereto.”.
-By definition of the Applicant’s specification, the “top surface” can be interpreted as a “side” or “portion” of the device, provided it meets the orientation requirement of facing away from the skin. Neither the claims, nor the specification preclude the interpretation that a part or portion of a top surface/side/portion faces away from the skin. Accordingly, the interpretation of the specification and the claims is consistent with the broadest reasonable interpretation (i.e., the Examiner interpretation) in that the top surface of Lian refers to a side or portion of the device, which the corresponding contact terminals, (ports 210) of the electronics module (electronics controller 200), in FIG. 1A-4, and the contact terminals (electrical conducting terminals 140) of the electrically conductive tracks (wires 130), FIG. 1A-4, are on the “side” or “portion” of the electronics module (electronics controller 200); in addition to at least portions of the corresponding contact terminals ((ports 210), and the contact terminals (electrical conducting terminals 140) are facing away from the skin, FIG. 3A, as interpreted in view of the broadest reasonable interpretation and in view of the Applicants specification. Note; the goal of Lian is to achieve disposable unit configured to be adhered to a patient’s skin, ¶0013.
-Lian provides contextual evidence regarding the nature of the components surrounding and containing the wires 130, which implies flexibility, integral to the design. The conducting wires 130 connect the electrodes 120 to the electrical conducting terminals, ¶0044. The conducting wries 130, along the electrical conducting terminals 140, are enclosed inside the disposable unit 100, ¶0044. Crucially, the disposable unit has a watertight housing that is made of a flexible biocompatible polymer, ¶0044, ‘Both conducting wires 130 and the electrical conducting terminals 140 are enclosed inside the disposable unit 100 which has a watertight housing that is made of a flexible biocompatible polymer.’. The disposable unit is configured to be adhered to the patient’s skin and includes a substantially flat and flexible skin contacting portions, ¶0013. The watertight chamber (which accommodates the electronic controller 200) is attached to or integrated within this flat and flexible skin contacting portion, ¶0016-0017. Hence, the wires 130 would be flexible such that the goal of achieving flexible design is accomplished.
Note; Gehman is relied upon to teach the inclined surface, see FIG. 4 highlighted above.
Note; Lian teaches wires 130 (i.e., electrically conductive tracks) as being flexible, see ¶0013, ¶0016-0017, ¶0044, supported by the context and design requirement.
Therefore, it would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the device of Gehman such that it includes electrically conductive tracks electrically connecting said one or more electrodes to the electronics module, wherein the electrically conductive tracks extend along the first and second skin facing surfaces, and to include the electrically conductive tracks to comprise contact terminals in contact with corresponding contact terminals on the top surface of the electronics module as taught by Lian for the advantage of providing an improved apparatus with such an apparatus being able to electrically connect the respective electrodes, as suggested by ¶0047 of Lian.
The modified combination would disclose: wherein the electrically conductive tracks (of Lian) extend along the first and second skin facing surfaces and along the inclined surface (of Gehman)
Gehman fails to disclose the specific dimensions of the electronics module having a height defining a distance between the bottom and top surfaces of between 0.5 cm and 2 cm. (i.e., wherein the electronics module has a height defining a distance between the bottom and top surfaces of between 0.5 cm and 2 cm), as required by the claim.
However, Bernstein in the context of medical devices (i.e., adhesive patches) for attachment on a skin surface on the body of a user includes an electronics 110 (i.e., an electronics module), discloses, wherein the electronics module has a height defining a distance between the bottom and top surfaces of between 0.5 cm and 2 cm (¶0111, ‘Referring to FIGS. 2A-2B, on body electronics 110 in certain embodiments is sized and shaped such that the height or thickness profile is minimized (for example, to less than or equal to about 10 mm, e.g., or less than or equal to about 7 mm, e.g., or less than or equal to about 5 mm, e.g., or less than or equal to about 4.5 mm, e.g., or less than or equal to about 4 mm or less).’)
-Less than or equal to about 10 mm equates to (1 cm).
-Less than or equal to about 7 mm equates to (0.7 cm).
-Less than or equal to about 5 mm equates to (0.5 cm).
Therefore, Bernstein teaches, “explicitly discloses” wherein the electronics module (body electronics 110) has a height defining a distance between the bottom and top surfaces of between 0.5 cm and 2 cm.
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the height of the electronics module of modified Gehman such that it is a height of 1 cm or 0.7 cm or 0.5 cm as taught by Bernstein. The motivation to do this yield predictable results such as minimizing the height profile of the electronics module to optimize the device for reduction, thereby maximizing comfort for the user during use and wear, as suggested by Bernstein, ¶0111, ¶0115.
Although Gehman discloses, analyzing signals provided by the electrodes used to monitor physiological condition of the subject (¶0010, ¶0026); Gehman fails to disclose and measuring a bio-impedance signal of the subject via the wearable sensor device.
However, Arne in the context of electronic modules for capturing physiological and physical parameters associated with a living subject discloses, and measuring a bio-impedance signal of the subject via the wearable sensor device. ([0029], ‘For example, the re-wearable wireless device 102 may be configured to monitor parameters, such as, without limitation, skin impedance, electro cardiogram signals, conductively transmitted current signal, position of wearer, temperature, heart rate, perspiration rate, humidity, altitude/pressure, global positioning system (GPS), proximity, bacteria levels, glucose level, chemical markers, blood oxygen levels, among other physiological and physical parameters.’)
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the electronic module of modified Gehman to be configured to measure a bio-impedance signal of the subject via the wearable device as taught by Arne. The motivation to do this yields predictable results such as ensuring reliable contact conditions between the skin and the monitoring device (i.e., skin impedance).
Claim 16: Modified Gehman discloses all the elements above in claim 1, Gehman discloses, wherein the first skin facing surface is adapted to extend along the circumference of the second skin facing surface in an amount of from 50% to 100%.
-Referring to FIG. 1 of Gehman discloses, wherein the first skin facing surface is adapted to extend along the circumference of the second skin facing surface in an amount of from 50% to 100%. The limitation “an amount of from 50% to 100%” merely amounts to the first skin facing surface extends along the circumference of the second skin facing surface in an amount of 100%. In other words, the second skin facing surface is within the first skin facing surface. Accordingly, the first skin facing surface would extends 100% along the circumference of the second skin facing surface.
Claim 18: Modified Gheman discloses all the elements above in claim 15, Gehman discloses, wherein an elevation distance between the first and second skin facing surfaces, joined by the inclined surface, corresponds to the height of the electronics module. (see highlighted figures below)
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Here below is a side-by-side comparison of Gehman structure compared to the Applicant’s structure, both of which are substantially identical,
-The elevation distance between identified first and second skin facing surfaces, are joined by the inclined surface, corresponding to the height of the electronics model (12) of Gehman, see the side-by-side comparison above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Wawro et al (US 2019/0150739 A1) discloses a modular vital signs monitor having a module wearable by the subject with conductive traces each having a different diameters along a surface.
Hadley et al (US 2018/0035909 A1) discloses a conductive adhesive connection to electronics module with conductive traces in electrical contact to the electronics modules.
Balczewski et al (US 2019/0282167 A1) discloses a wearable device patch connection with an electronics module and flexible circuit assembly disposed between the upper and lower surfaces configured to electrically couple the sensors to the electronics module.
Manicka et al (US 2014/0330136 A1) discloses an adherent device with multiple sensors connected to an electronics module wherein the flexible printed circuit board includes a plurality of traces that extend to connectors along surface portions.
Kroecker et al (US 2006/0155183 A1) disclose an electronics module with conductive tracks along surface portions of the device.
Bianchi (US 2016/0331961 A1) discloses an electronics module with a flexible circuit, both disposed and connected along surface portions defined by a gap.
Semler (US 2003/0069510 A1), discloses a wearable sensor device with multiple skin facing surfaces, with a base structure comprising an inclined surface joining the skin facing surfaces, one or more electrodes arranged on the first skin facing surface providing an electrical signal of the subject, an integrated circuit (electronics module) having a bottom and top surface, where the second skin facing surface of the base structure covers the entire top surface of the electronic module, electrically conductive tracks corresponding to respect contact terminals when the wearable device is arranged to contact the skin of the subject.
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 Nicholas Robinson whose telephone number is (571)272-9019. The examiner can normally be reached M-F 9:00AM-5:00PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Pascal Bui-Pho can be reached at (571) 272-2714. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/N.A.R./Examiner, Art Unit 3798
/PASCAL M BUI PHO/Supervisory Patent Examiner, Art Unit 3798
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