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 .
Amendment Entered
This Office action is responsive to the Amendment filed on August 25th, 2025. The examiner acknowledges the cancellation of claims 1-32. Claims 33-34 have been added.
Response to Arguments
Applicant’s arguments, filed, 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 § 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 33 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 33 recites the limitation "the plurality of electrodes" in line 23. There is insufficient antecedent basis for this limitation in the claim. The limitation is suggested to recite “aligned with one the exposed surfaces of the first and second sensing electrode or ground electrode”.
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 33 is rejected under 35 U.S.C. 103 as being unpatentable over Mazar (US 20140012154 A1) in view of Lunner (US 20160081623 A1), further in view of Donnett (US 20080243022 A1), further in view of Trapero (US 20250017532 A1), and further in view of Elwood (US 20220338792 A1).
Regarding claim 33, Mazar disclose a wearable activity signal sensor sized, adapted and configured to be secured at a location on a subject, comprising: a flexible electrode housing, the flexible electrode housing having a skin-facing surface; only one pair of first and second sensing electrodes secured to the flexible electrode housing (two inner/measurement electrodes 112B & 112C; “two electrodes to measure”, para. [0009, 0053, 0062]) and spaced apart (unlabeled, but as seen in figs. 1C, 1H); wherein each of the first electrode, second electrode, having at least one exposed surface (unlabeled, but as seen in figs. 1H, 1I, 1J); and 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”, para. [0049, 0075]), the electronics member including a plurality of electrode couplers (connectors 122A-D, para. [0055], figs. 1D & 1I) each sized and positioned to be placed in electrical communication with one of the exposed surfaces of the first and second sensing electrode or ground electrode when the electronics member is coupled with the flexible electrode housing (“electrically couple the flex PCB with the electrodes”, para. [0055], as seen in 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 disclose the first and second sensing electrodes spaced apart at a first distance therebetween; a ground electrode secured to the flexible electrode housing and spaced from the first and second sensing electrodes, the ground electrode spaced from a nearest of the first and second sensing electrodes at a second distance greater than the first distance, wherein each of the first electrode, second electrode, and ground electrode having at least one exposed surface, the first and second sensing electrodes and the ground electrode each having a skin-facing surface.
However, Lunner directed to a hearing assistance system having first and second parts configured for picking up EEG signals comprising EEG and reference electrodes (para. [0074]) discloses only one pair of first (EEGe11, fig. 1B) and second (EEGe12, fig. 1B) sensing electrodes (“active EEG-electrode”; “EEG-electrodes”, para. [0004, 0087]), the first and second sensing electrodes spaced apart at a first distance therebetween (distances between the electrodes are necessarily small (e.g., S10 mm), para. [0004]); a ground electrode (REFe/REFe1/REFe2, para. [0004], figs. 1A-1B & 3) secured to the housing (P1/P2, fig. 3) (“REFe2 … located at … a surface of the … housing to allow … contact the skin”; “hearing devices each comprise EEG-electrodes … and a reference electrode”, para. [0089, 0096], as seen in fig. 3) and spaced from the first and second sensing electrodes (as seen in figs. 1A-1B & fig. 3), the ground electrode spaced from a nearest of the first and second sensing electrodes at a second distance greater than the first distance ((to reduce or avoid ‘cross-talk’ between them), the reference electrode is preferably located at a distance from the EEG-electrodes, e.g. larger away than the typical distance between the active EEG-electrodes (e.g. larger than 10 mm, such as larger than 50 mm), as seen in figs. 1A-1B), wherein each of the first electrode, second electrode, and ground electrode (EEGe11 & EEGe12 & REFe/REFe2, figs. 1A-1B) having at least one exposed surface (unlabeled, but as seen in figs. 2C-3), the first and second sensing electrodes and the ground electrode each having a skin-facing surface (EEGe11 & EEGe12 & REFe2 as seen in fig 1B). Lunner further discloses the electrodes of the ear pieces are positioned to have electrical contact with the skin of the user to enable the sensing of brainwave signals (para. [0093]).
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 wearable activity signal sensor comprises only one pair of first and second sensing electrodes spaced apart at a first distance therebetween; a ground electrode secured to the flexible electrode housing and spaced from the first and second sensing electrodes, the ground electrode spaced from a nearest of the first and second sensing electrodes at a second distance greater than the first distance, wherein each of the first electrode, second electrode, and ground electrode having at least one exposed surface, the first and second sensing electrodes and the ground electrode each having a skin-facing surface, in view of the teachings of Lunner, as such a modification would have been merely a substitution of the electrodes of Mazar for the active electrodes and reference electrode of Lunner in order to position the electrodes to have electrical contact with the skin of the user to enable sensing of brainwave/EEG signals and reduce or avoid ‘cross-talk’ (Lunner, para. [0004, 0093]).
Mazar, as modified by Lunner hereinabove, does not disclose the sensor configured to operate in a monopolar sensing mode between each of the first and second sensing electrodes and the ground electrode, and in a bipolar sensing mode between the first and second sensing electrodes.
However, Donnett discloses the sensor (electrode assembly 200A, para. [0097]) configured to operate in a monopolar sensing mode between each of the first and second sensing electrodes and the ground electrode, and in a bipolar sensing mode between the first and second sensing electrodes (figures 3A & 3C- 3D, para. [0096, 0105], the at least one electrode 102 can include multiple electrodes ... for monopolar or bipolar intrinsic neural signal acquisition, ... a voltage observed between first and second electrodes; the user-provided information can be used for electrode configuration ... monopolar, bipolar, tripolar ... used for acquiring intrinsic brain signals).
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 Lunner hereinabove, such that the sensor is configured to operate in a monopolar sensing mode between each of the first and second sensing electrodes and the ground electrode, and in a bipolar sensing mode between the first and second sensing electrodes, in view of the teachings of Donnett, as such a modification would have yielded predictable results, namely acquiring intrinsic brain signals by incorporating user-provided information to select which electrode(s) of a particular electrode assembly are used for acquiring intrinsic brain signals, or whether a monopolar, bipolar, tripolar, or other electrode configuration is used for acquiring intrinsic brain signals (Donnett, para. [0096, 0105]).
Mazar, as modified by Lunner and Donnett hereinabove, does not disclose the flexible electrode housing flexible to facilitate conformability between the sensor and the subject's skin.
However, Trapero directed to a wearable smart patch 800 having electrodes 982A-F and a detachable electronics module 802 (figs. 8-9, para. [0107-0110]) discloses the flexible electrode housing flexible to facilitate conformability between the sensor and the subject's skin (“shaped to fit comfortably … flexible … conforms”, “flexible … facilitate adhesion … to the user’s skin … while conforming to the shape of the user’s anatomy”, para. [0104, 0127]). Trapero further discloses that the material of the flexible patch 660 and its design can facilitate long-term adhesion to the user without discomfort (para. [0100]).
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 Lunner and Donnett hereinabove, such that the flexible electrode housing is flexible to facilitate conformability between the sensor and the subject's skin, in view of the teachings of Trapero, for the obvious advantage of facilitating long-term adhesion to the user without significant discomfort by conforming to the shape of the user’s anatomy.
Mazar, as modified by Lunner, Donnett, and Trapero hereinabove, does not disclose a wearable brain activity signal sensor sized, adapted and configured to be secured at a behind an 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, as modified by Lunner, Donnett, and Trapero hereinabove, 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, for the obvious advantage of 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]).
Claim 34 is rejected under 35 U.S.C. 103 as being unpatentable over Mazar (US 20140012154 A1) in view of Trapero (US 20250017532 A1), and further in view of Elwood (US 20220338792 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]); and 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”, 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 the flexible electrode housing being flexible to facilitate conformability between the wearable activity signal sensor and the subject's skin, and each of the plurality of electrodes having a skin-facing surface.
However, Trapero directed to a wearable smart patch 800 having electrodes 982A-F and a detachable electronics module 802 (figs. 8-9, para. [0107-0110]) discloses the flexible electrode housing flexible to facilitate conformability between wearable activity signal sensor and the subject's skin (“shaped to fit comfortably … flexible … conforms”, “flexible … facilitate adhesion … to the user’s skin … while conforming to the shape of the user’s anatomy”, para. [0104, 0127]) and each of the plurality of electrodes having a skin-facing surface (unlabeled, but as seen in fig. 9, “ skin-electrode interface”; “”dry” electrode … directly contacts the user’s skin”, para. [0012, 0123, 0126]). Trapero further discloses that the material of the flexible patch 660 and its design can facilitate long-term adhesion to the user without discomfort (para. [0100]).
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 flexible electrode housing is flexible to facilitate conformability between the wearable activity signal sensor and the subject's skin, and each of the plurality of electrodes having a skin-facing surface, in view of the teachings of Trapero, as such a modification would have been merely a substitution of the electrodes of Mazar for the “dry” electrodes of Trapero that directly contact the user’s skin and would provide the obvious advantage of facilitating long-term adhesion to the user without significant discomfort by conforming to the shape of the user’s anatomy.
Mazar, as modified by Trapero hereinabove, does not expressly disclose a 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, as modified by Trapero hereinabove, 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, for the obvious advantage of 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]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Reykhert (US 20210241900 A1) directed to a smart patch 100 having a body 102 comprising PCBs 206 & 214, an adhesive 108 supporting electrodes 106, and metal connectors 218 to facilitate connection of the electrodes to the PCB (para. [0032, 0040-0044], fig. 2B)
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 ANDREW ELI HOFFPAUIR whose telephone number is (571)272-4522. The examiner can normally be reached Monday-Friday 8:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Marmor II can be reached at (571) 272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHARLES A MARMOR II/Supervisory Patent Examiner
Art Unit 3791
/A.E.H./Examiner, Art Unit 3791