DETAILED ACTION
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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on April 29th, 2026 has been entered.
Claim 34 remains pending in the application. Claims 1-33 are cancelled.
Response to Arguments
Applicant’s arguments with respect to the rejections under 35 U.S.C. 112(b) have been considered and are moot because claim 33 has been cancelled.
Applicant’s arguments with respect to the rejections under 35 U.S.C. 103 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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.
Claim 34 is rejected under 35 U.S.C. 103 as being unpatentable over Mazar (US 20140012154 A1 – previously cited) in view of Elwood (US 20220338792 A1 – previously cited), further in view of Datta (US 20220296165 A1), and further in view of Clements (US 20200138313 A1).
Regarding claim 34, Mazar discloses a wearable activity signal sensor (adherent device 100, fig. 1A) sized, adapted and configured to (Examiner’s Note: functional language/intended use, i.e., capable of) be at a location on a subject (“adhered to a patient P at many locations”, para. [0045]), comprising: a flexible electrode housing (adherent patch 110, figs. 1B-C; “thin, flexible, breathable patch, para. [0077]) comprising a plurality of electrodes (electrodes 112A-112D, para. [0053], figs. 1B-1C), the flexible electrode housing having a skin-facing surface (patient side 110A, para. [0053]); an electronics member (electronics housing 160 & waterproof cover 162, figs. 1G-1H, “electronics module”, para. [0044]) that is configured and sized to be releasably coupled with the flexible electrode housing (“reusable electronics module”; “electronics module … removable ... releasable connection”, para. [0049, 0075]), the electronics member including a plurality of electrode couplers (connectors 122A-D, para. [0055], figs. 1D & 1I), each of which is sized and positioned to be placed in electrical communication with one of the plurality of electrodes when the electronics member is coupled with the flexible electrode housing (“electrically couple the flex PCB with the electrodes”, para. [0055], fig. 1I), where each of the plurality of electrode couplers (connectors 122A-D, para. [0055]) is, in a side view of the wearable activity signal sensor (as seen in fig. 1I), aligned with one of the plurality of electrodes (“connectors 122A … positioned on flex PCB 120 in alignment with electrodes 112A …”, para. [0055], as seen in fig. 1I).
Mazar does not expressly disclose a/the wearable brain activity signal sensor sized, adapted and configured to be secured at the behind the ear location on a subject.
However, Elwood discloses a wearable brain activity signal sensor (sensor 101a,b, figs. 1A-1B, “EEG”, Abstract) sized, adapted and configured to be at a behind an ear location on a subject (“behind ear”; “small size … worn continuously”, para. [0024, 0026], fig. 1B). Elwood further discloses the sensor features a small size and can be located in a variety of positions, reducing the burden on the user during prolonged wear and that the sensor is designed to be discreet and water-resistant, allowing for continuous use in all facets of a person's normal daily life (para. [0021, 0024]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Mazar such that the smart patch is a wearable brain activity signal sensor sized, adapted and configured to be at a behind an ear location on a subject, in view of the teachings of Elwood, as this would aid in providing a discreet and water-resistant sensor with a small size that can be located in a variety of positions, reducing the burden on the user during prolonged wear, and facilitating long-term monitoring of EEG data (Elwood, para. [0021, 0024, 0026-0027]).
Mazar, as modified by Elwood hereinabove, does not disclose does not disclose that the plurality of electrodes is a plurality of flexible electrodes, the flexible electrode housing and the flexible electrodes are both flexible to facilitate conformability between the wearable brain activity signal sensor and the subject's skin, each of the plurality of flexible electrodes having a skin-facing surface, and a photoplethysmography sensor.
However, Datta directed to a wearable patch discloses a flexible electrode housing (flexible patch body 211, para. [0044], fig. 2b) and a plurality of flexible electrodes (“flexible electrodes”, para. [0050-0051, 0079], dry electrodes 241 & 242, as seen in fig. 2b), the flexible electrode housing (211, fig. 2b) and the flexible electrodes (241 & 242, fig. 2b) are both flexible (“flexible”, para. [0044, 0079]) to facilitate conformability between the wearable activity signal sensor and the subject's skin (“flexible patch body conforms to the body contour”; “flexible electrodes … improves overall conformability”, para. [0044, 0079]), each of the plurality of flexible electrodes having a skin-facing surface (“contact the user’s skin … dry electrodes”; “skin-electrode contact”, para. [0050-0051, 0063, 0079], as seen in fig. 2b & 2h), and a photoplethysmography sensor (PPG sensor 248, fig. 2b, para. [0053, 0128, 0153]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Mazar, as modified by Elwood hereinabove, such that that the plurality of electrodes are flexible electrodes, the flexible electrode housing and the flexible electrodes are both flexible to facilitate conformability between the wearable brain activity signal sensor and the subject's skin, each of the plurality of flexible electrodes having a skin-facing surface, in view of the teachings of Datta, as this would aid in improving the overall conformability to the user’s body, providing non-irritating contact with the skin, avoiding the need for gels, and enhancing the electrical connection with the skin while reducing motion artifacts by incorporating the flexible hydrogel electrodes of Datta (Datta, para. [0044, 0050, 0079]).
Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Mazar, as modified by Elwood and Datta hereinabove, such that that wearable brain activity signal sensor comprises a photoplethysmography sensor, in view of the teachings of Datta, as this would aid in obtaining PPG signals for detecting saturated oxygen levels of the user (Datta, para. [0053, 0153]).
Mazar further discloses that the patches are replaceable/disposable and that the releasable connection may be Velcro.TM., a known hook and loop connection, and/or snap directly to the electrodes (Mazar, para. [0049, 0075]). Mazar, as modified by Elwood and Datta hereinabove, does not disclose that the electronics member is configured and sized to be magnetically releasably coupled with the flexible electrode housing.
However, Clements directed to an electrode patch discloses an electrode patch 100 including a flexible substrate 102, an electrode array 104 comprising electrodes 106 arranged on the flexible substrate (para. [0054], fig. 2), an electronics module 150 (para. [0064, 0067], fig. 12), and that the electronics member is configured and sized to be magnetically releasably coupled with the flexible electrode housing (“electronics module … magnetic connector 132 … electrode patch … magnets 134 are used to mechanically couple”; “disposable”, para. [0064, 0124, 0140]). Clements further discloses that a connector is important to interface the electrode patch with external electronics and that the electrode patch is designed to be disposable (para. [0140]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Mazar, as modified by Elwood and Datta hereinabove, such that the electronics member is configured and sized to be magnetically releasably coupled with the flexible electrode housing, as such a modification would have been merely a substitution of the Velcro.TM., known hook and loop connection, and/or snap connection of Mazar for the magnetic connector comprising magnets of Clements as this would aid in mechanically coupling a disposable electrode patch and reusable electronics member.
Conclusion
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/A.E.H./Examiner, Art Unit 3791
/AURELIE H TU/Primary Examiner, Art Unit 3791
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