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 .
Response to Amendment
The amendment filed 03/24/2026 has been entered. Claims 1-15 remain pending in the application.
Response to Arguments
Applicant's arguments with respect to claims 1-15 have been considered but are not seen as persuasive, see reasoning below.
Regarding claim 1, applicant argues that Lappalainen does not explicitly disclose a carrier structure that is a shape-stable within a tolerance range without external force exerted by a user and deformed under external force exerted by the user. While applicant does not define “shape-stable” in the claim nor in the specification or arguments, examiner interprets “shape-stable” as a material that will retain its physical geometry and not deform under stress, such that claim 1 recites that the carrier structure will deform under external force by the user. Such that, looking at Lappalainen, Figure 2, the carrier structure, 100, maintains the shape and configuration shown when no external force is exerted by the user. Examiner also wants to acknowledge in Paragraph [0028] of Lappalainen, it is stated that carrier structure (the body part) structure is the reasons the positions of the electrodes remain unchanged and the positioning of the electrodes are in the correct places on the persons face therefore basically proving that the carrier structure is shape-stable since the physical geometry is retain and does not deform under stress within a tolerance range, such when a user applies external force to the carrier structure to attach the electrodes then the carrier structure will bend to fit around a patients head therefore not changing the overall shape, only allowing for it to be applied to a head which is curved. Applicant also argues that a person skilled in the art would not even consider to combine Lappalainen with Souhoka since Lappalainen does not require separate gels or pastes for attachment. Examiner wants to point towards MPEP 2145 III in which it is stated “The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference.... Rather, the test is what the combined teachings of those references would have suggested to those of ordinary skill in the art.". Therefore, it would be obvious for a person skilled in the art to come to the conclusion to use a device like Lappalainen but with wet electrodes especially since wet electrodes are widely used in the art. Therefore, Examiner stands by the rejection.
Regarding claim 5, Examiner is persuaded by the argument that Lappalainen does provide a shape for below the ear and not above the ear. Therefore, Examiner is reopening and new rejection of claim 5 is provided below.
Regarding claim 7, applicant argues that Blum disclosed a sleeve to be worn on an arm therefore by amending the claim, it is more direct to the user is applying the electrode arrangement to the head and not the arm. Examiner disagrees, while the amended claim 7 now recites the electrode arrangement is to be worn on the head of the user, Lappalainen already discloses the electrode arrangement to be worn on the head. Lappalainen does not disclose wherein the carrier structure is configured to extend a distance between two electrodes of the electrode arrangement by a maximum of 10%. While Blum’s electrode structure is worn on the arm, examiner uses the art to teach a carrier structure material that allows for extension within a distance between two electrodes of the electrode arrangement by a maximum of 10%. Therefore, the combination of Lappalainen in view of Souhoka device, and using the carrier structure material taught by Blum allows for this deficiency to be taught. Therefore, Examiner stands by the rejection.
Regarding claim 8, applicant argues that Toth does not explicitly the removable stiffening member element is to be attached on a side facing away from the electrode arrangement. In which as stated in the non-final rejection, Lappalainen discloses this portion of the claim in paragraph [0032]. Toth is brought in to disclose the deficiency of the stiffening element being removable. Applicant argues that this would not be possible in Lappalinen device in which examiner wants to point towards MPEP 2145 III in which it is stated “The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference.... Rather, the test is what the combined teachings of those references would have suggested to those of ordinary skill in the art.". Such that it would be obvious to onw of the ordinary skill in the art to create a device similar to Lappalainens that would allow for a removable stiffening element. Therefore, Examiner stands by the rejection.
Claim Interpretation
The use “for” in the claim is seen as intended use and therefore is given limited patentable weight and the prior art used below would be capable of performing the “for” function based on structure.
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.
Claims 1-4, 6, 9-12 & 14-15 is rejected under 35 U.S.C 103 as being unpatentable over Lappalainen et al (US 20150238106) herein referred to as Lappalainen, in view of SOUHOKA et al. (US 20200383594) herein referred to as SOUTHOKA.
Regarding Claim 1, Lappalainen discloses a device (Figure 2) comprising: an electrode arrangement with a plurality of electrodes for measuring electric signals on a face surface of a head of a user and behind an ear of the user (Figure 1 & Figure 2), a carrier structure (Figure 1, 100); wherein the carrier structure at least partially defines a relative position of the electrodes to one another (Paragraph [0023]; wherein carrier structure 100 according to the disclosure can include an electrode placement configuration, by means of which the mutual placements of the electrodes 102 can be maintained essentially the same with respect to one another); and wherein the carrier structure is shape-stable within a tolerance range without external force exerted by a user and deformable under external force exerted by the user in order to change a distance between two adjacently arranged electrodes and to area-comprehensively adapt to face and head structures (Figure 2, Paragraph [0028]; wherein the carrier structure conforms to the contours of a face when applied to a user, such that when being applied to a user, force would be being applied to attach the carrier structure the face), wherein the carrier structure is configured to position at least a part of the electrode arrangement on the face surface and behind the ear (Figure 1, Paragraph [0028]; wherein the electrodes fixed to the body part can be placed in the hairless areas on the patient's forehead, temples, cheeks and bridge of the nose, as well as behind the ears. In addition, one electrode can be placed on the chest for ECG monitoring); wherein the carrier structure is configured in the shape of a net structure with branching connecting ribs that follow a course of the face surface (Figure 2, Paragraph [0028]; wherein the electrodes fixed to the body part can be placed in the hairless areas on the patient's forehead, temples, cheeks and bridge of the nose, as well as behind the ears. In addition, one electrode can be placed on the chest for ECG monitoring); and wherein the branched connecting ribs comprise a rib width corresponding to, at most, three times the electrode diameter of an electrode of the plurality of the electrodes (See annotated Figure 2 below) . However, Lappalainen does not explicitly disclose wherein the electrodes of the plurality of electrodes are wet electrodes.
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SOUHOKA discloses a device for measuring electric signals of a user (Figure 3) wherein the electrodes of the plurality of electrodes are wet electrodes (Paragraph [0047]; wherein electrodes are formed as wet electrodes). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the electrodes as taught by Lappalainen. The motivation being for easy removal and application (SOUHOKA, Paragraph [0026]).
Regarding claim 2, Lappalainen in view of SOUHOKA discloses the device according to claim 1. Lappalainen also discloses wherein the carrier structure follows the face surface as a human face shape (Figure 1 & Figure 2; wherein the carrier structure when applied to the face follows the electrode marks shown in Figure 1), and the plurality of electrodes are arranged on the carrier structure (Figure 2, 102); wherein a first electrode position that is assigned to a first electrode of the plurality of electrodes corresponds to a position of a first distinctive point (B) of the face surface (See annotated Figure 1); and a second electrode position that is assigned to a second electrode of the plurality of electrodes corresponds to a position of a second distinctive point (A) of the face surface (See annotated Figure 1); and a third electrode position that is assigned to a third electrode of the plurality of electrodes results starting from the first electrode position and the second electrode position on the face surface within a tolerance range determined by the carrier structure (See annotated Figure 1).
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Regarding claim 3, Lappalainen in view of SOUHOKA discloses the device according to claim 2. Lappalainen also discloses wherein the first distinctive point (B) of the face surface corresponds to an upper cheekbone (See annotated Figure 1 below), and the second distinctive point (A) corresponds to a position in front of the tragus of an ear of the user (See annotated Figure 1 below); and wherein the carrier structure comprises a connecting rib that at least partially connects the first electrode position and/or the second electrode position, on one side, to the third electrode position, on the other side, and wherein the third electrode position corresponds, within a tolerance range of 1 to 2 cm determined by the carrier structure (See annotated Figure 2 below; Paragraph [0061]; wherein the carrier structure is made up a polyester film such that it is flexible and conforms better to the contours of the face therefore would allow for a tolerance range of 1 to 2cm), to a position (C) on a forehead of the face surface in an area of 1 cm to 3 cm above the eyebrow line, vertically above a nasion of the user (See annotated Figure 1); and/or wherein the carrier structure comprises a connecting rib that at least partially connects the first electrode position and/or the second electrode position, on one side, to a fourth electrode position that is assigned to a fourth electrode of the plurality of electrodes (See annotated Figure 2 below), on the other side, and wherein the fourth electrode position corresponds, within a tolerance range determined by the carrier structure, to a position (D) behind the ear of the user (See annotated Figure 1 below); and/or wherein the carrier structure comprises a connecting rib that at least partially connects the first electrode position and/or the second electrode position, on one side, to a fifth electrode position that is assigned to a fifth electrode of the plurality of electrodes, on the other side, and wherein the fifth electrode position corresponds, within a tolerance range determined by the carrier structure, to a position (E) on the chin of the face surface of the user.
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Regarding claim 4, Lappalainen in view of SOUHOKA discloses the device according to claim 1. Lappalainen also discloses wherein the electrodes further comprise an adhesive electrolyte gel for lowering the impedance and for affixing the plurality of electrodes and the carrier structure on the face surface (Paragraph [0033]; wherein a good contact of the electrodes with the skin can be ensured by areas of hydrogel film attached at the electrodes. In accordance with an exemplary embodiment, a booster is in addition used non-conductive hydrogel around each electrode, such that hydrogel is widely used an electrolyte gel); wherein the adhesive electrolyte gel is covered, at least in some sections, by a removable protective film (Paragraph [0033]; wherein the hydrogel layer can be covered with a protective layer (release liner layer) which gives support during the mounting of the electrode). SOUHOKA discloses wherein the carrier structure comprises an adhesive material for affixing the plurality of electrodes and the carrier structure on the face surface (Figure 1, 105b) and wherein the adhesive material is covered by the removable protective film (Figure 1, 107b), wherein the protective film comprises a plurality of protective film portions that are independently removable from the carrier structure and the plurality of electrodes (Figure 1, 107a & 107b). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the carrier structure and electrodes as taught by Lappalainen to include the adhesive material and protective films as taught by SOUHOKA. The motivation being this allows the electrode carrier to be fully prepared, ready for use, and requiring only the removable layer to be peeled off for use as well as allows for clean storage and transportation and prevention of the electrode carrier to stick to other objects, more specifically packaging, prior to use (SOUHOKA, Paragraph [0031])
Regarding claim 6, Lappalainen in view of SOUHOKA discloses the device according to claim 1. Lappalainen also discloses wherein a shape of the carrier structure is configured to position the plurality of electrodes at a corresponding plurality of positions on the face surface (Figure 1 & Figure 2); wherein the plurality of positions is configured for a detection of the electric signals on the face surface for at least one linear combination of the electric signals for mapping signals from a predetermined head region of the user (Paragraph [0011]; wherein the arrangement includes electrodes for producing measurement data connected to the body part; means for transmitting the measurement data connected to the body part; a measurement data unit for receiving the measurement data transmitted by the means for further processing of the measurement data, and which body part includes an electrode placement configuration for maintaining mutual placements of the electrodes with respect to one another, and an electroconductive active attachment surface located between the electrodes and the surface of the skin for forming an electroconductive attachment contact between the electrodes and the surface of the skin for transmitting measurable signals from the patient's head to the electrodes through the electroconductive active attachment surface to produce measurement data).
Regarding claim 9, Lappalainen in view of SOUHOKA discloses the device according to claim 1. Lappalainen also discloses wherein the carrier structure comprises at least one extension comprising an adhesive material at a position at which an electrode of the electrode arrangement is arranged (Paragraph [0033]; wherein A good contact of the electrodes with the skin can be ensured by areas of hydrogel film attached at the electrodes. In accordance with an exemplary embodiment, a booster is in addition used non-conductive hydrogel around each electrode).
Regarding claim 10, Lappalainen in view of SOUHOKA discloses the device according to claim 1. Lappalainen also discloses wherein the plurality of electrodes comprises active electrodes comprising a circuit that is configured to perform an impedance conversion of the measured electric signal, and/or amplify the measured electric signal (Paragraph [0033]; each of the transmission lines, which are connected to the electrodes, ends in the sensor's projecting part, from which the measured signals can be guided by means of a quick coupling to an amplifier. A coupling can be used, which can be either an MRI-compatible coupling or an easily disconnected/reconnected coupling, for example so-called ZIF-type connector.).
Regarding claim 11, Lappalainen in view of SOUHOKA discloses a system (Paragraph [0011]) comprising: a device according to claim 1 (See claim 1 rejection above); and an evaluation arrangement that is configured to evaluate the electric signals measured by the plurality of electrodes (Lappalainen, Paragraph [0011]; wherein a measurement data unit for receiving the measurement data transmitted by the means for further processing of the measurement data such that the means for processing of the measurement data is seen as evaluation arrangement)
Regarding claim 12, Lappalainen in view of SOUHOKA discloses the system according to claim 11. Lappalainen also discloses wherein the evaluation arrangement is configured to, based on the electric signals provide an information on a sleep architecture of the user; or provide an information on an epileptic behavior of the user; or indicate a neurological disorder of the user; or provide a cognitive psychological information (Paragraph [0038]; wherein the system can provide information of epileptic behavior; Paragraph [0060]; wherein the system can diagnosis brain-related disorders which is the same as neurological disorders).
Regarding claim 14, Lappalainen in view of SOUHOKA discloses a method (Paragraph [0036]) for using the device according to claim 1 (See claim 1 rejection above), comprising: applying the device on a face surface of a head of a user by the user themselves or by another person (Lappalainen, Paragraph [0036]; wherein a paramedic is able to attach the disclosure on the patient's forehead and face within a few minutes); monitoring the user by means of the electric signals measured by the plurality of electrodes (Lappalainen, Paragraph [0036]; wherein changes in the EEG due to possible conditions requiring emergency care can be detected immediately and the patient can be referred to the appropriate treatment as quickly as possible).
Regarding claim 15, Lappalainen in view of SOUHOKA discloses the method according to claim 14. Lappalainen also discloses wherein applying the device on the face surface of the head of the user comprises: feeling an upper cheekbone and affixing a first electrode on the upper cheekbone (Paragraph [0036]; wherein a paramedic is able to attach the disclosure on the patient's forehead and face within a few minutes such that a paramedic will feel a cheekbone when affixing the electrode; See annotated Figure 1 below); affixing a second electrode in front of the tragus of an ear of the user (Paragraph [0036]; wherein a paramedic is able to attach the disclosure on the patient; See annotated Figure 1 below); affixing a third electrode on a forehead, vertically above a nasion, in an area of 1-3 cm above an eyebrow line (Paragraph [0036]; wherein a paramedic is able to attach the disclosure on the patient; See annotated Figure 1 below); affixing a fourth electrode behind the ear (Paragraph [0036]; wherein a paramedic is able to attach the disclosure on the patient; See annotated Figure 1 below).
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Claim 5 is rejected under 35 U.S.C 103 as being unpatentable over Lappalainen in view of SOUHOKA in view of Torch (US RE395339) herein referred to as Torch.
Regarding Claim 5, Regarding claim 5, Lappalainen in view of SOUHOKA discloses the device according to claim 1. Lappalainen also discloses wherein a connecting rib of the branching connecting rib is curved at one end so that the carrier structure comprises a curved end piece that is configured to be affixed behind an ear of the user (See annotated Figure 2 below), and wherein the connecting rib is configured to run from the face of the user below the ear to the curved end piece (See annotated Figure 2 below), and wherein at least one electrode of the plurality of electrodes is arranged at the curved end piece (See annotated Figure 2 below). . However, Lappalainen in view of SOUHOKA does not explicitly disclose the connecting rib to run from the face of the user above the ear to the curved end piece.
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Torch discloses a device (Figure 13) wherein a connecting rib of the branching connecting rib is curved at one end so that the carrier structure comprises a curved end piece that is configured to be affixed behind an ear of the user (Figure 13, 816), and wherein the connecting rib is configured to run from the face of the user above the ear to the curved end piece (Figure 13, 816; wherein branch 816 is connected to the 812 which is the face of the user and wraps bove the ear to the curved end piece), and wherein at least one electrode of the plurality of electrodes is arranged at the curved end piece (Figure 13, 856). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the connecting rib taught by Lappalainen in view of SOUHOKA to go above the ear instead of behind it. The motivation being it would be obvious to try different connecting rib locations around the ear to see what would provide the most comfort to the user as well as allow for accurate electrode measurements (MPEP 2143 (D)).
Claim 7 is rejected under 35 U.S.C 103 as being unpatentable over Lappalainen in view of SOUHOKA in further view of Blum et al. (US 20230191115) herein referred to as Blum.
Regarding Claim 7, Lappalainen in view of SOUHOKA discloses the device according to claim 1 wherein the carrier structure comprises polyurethane material, polymer material, and/or silicone material as a carrier material (Paragraph [0061]; wherein the carrier is made of Mylar and Mylar is a non-conductive polymer which is disclosed in Paragraph [0009]), wherein the carrier material is elastic or stretchable (Paragraph [0022]; wherein the carrier structure conforms to the patients face therefore is seen as elastic); wherein the electrodes are connected to conductive traces (Figure 2, 104), and wherein the conductive traces comprise a slung course on or in the carrier structure in order to correspondingly extend upon stretching of the carrier structure (Paragraph [0028]; wherein conductive traces 104 are integrated into the carrier structure). However, Lappalainen in view of SOUHOKA does not explicitly disclose wherein the carrier structure is configured to extend a distance between two electrodes of the electrode arrangement by a maximum of 10%.
Blum discloses a device for measuring electric signals (Figure 1) wherein the carrier structure is configured to extend a distance between two electrodes of the electrode arrangement by a maximum of 10% (Paragraph [0038]; wherein a there is stretch percentage of 7-25% of a carrier structure containing electrode). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the carrier structure disclosed by Lappalainen in view of SOUHOKA to be stretched by a maximum of 10% as taught by Blum. The motivation being allows for the device to be comfortably worn while producing sufficient compression force against the electrodes (Blum, Paragraph [0038]).
Claim 8 is rejected under 35 U.S.C 103 as being unpatentable over Lappalainen in view of SOUHOKA in view of Toth et al. (US 20150351690) herein referred to as Toth.
Regarding Claim 8, Lappalainen in view of SOUHOKA discloses the device according to claim 1 wherein on a side facing away from the electrode arrangement, the carrier structure comprises a stiffening element that is configured to at least locally stiffen the carrier structure (Paragraph [0032]; wherein the outmost layer is a stiffener layer which would locally stiffen the carrier structure). However, Lappalainen in view of SOUHOKA does not explicitly disclose wherein the stiffening element is removeable.
Toth discloses a device for measuring electric signals (Figure 1, 50) comprising a removeable stiffening element (Paragraph [0037]). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the carrier structure taught by Lappalainen in view of SOUHOKA to allow for the stiffening element to be removable as taught by Toth. The motivation being the temporary stiffening member configured to provide retention of the shape of the patch interface prior to attachment to the subject, the stiffening member being removable from the substrate after attachment to the subject (Toth, Paragraph [0037]).
Claim 13 is rejected under 35 U.S.C 103 as being unpatentable over Lappalainen in view of SOUHOKA in view of Thompson et al. (US 20140206976) herein referred to as Thompson.
Regarding Claim 13, Lappalainen in view of SOUHOKA disclose the system according to claim 11. However, Lappalainen in view of SOUHOKA does not explicitly disclose a hearing aid; wherein the evaluation arrangement is configured to control the hearing aid based on the electric signals, wherein the evaluation arrangement is configured to correlate the signals measured by the device with an envelope of an audio signal recorded by the hearing aid in order to control a beam former of the hearing aid.
Thompson discloses a system for measuring electric signals (Figure 30) comprising a hearing aid (Paragraph [0123]; wherein the subject 602 may wear a form or hearing aid); wherein the evaluation arrangement is configured to control the hearing aid based on the electric signals (Paragraph [0123]; wherein the feedback module allows for signals to be sent between the hearing aid and the device), wherein the evaluation arrangement is configured to correlate the signals measured by the device with an envelope of an audio signal recorded by the hearing aid in order to control a beam former of the hearing aid (Paragraph [0123]; wherein the signal is an audible frequency and may be implemented in the form of text-to-speech or in the form of audible "beeps" of varying pitch, which can be controlled to be “higher” or “lower” in a sense to construct melodies). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the system taught by Lappalainen in view of SOUHOKA to include the hearing aid as taught by Thompson. The motivation being to allow audio communication between the user and the device (Thompson, Paragraph [0123]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALYSSA M PAPE whose telephone number is (703)756-5947. The examiner can normally be reached M-F 7:30-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Rodden can be reached at 303-297-4276. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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ALYSSA M. PAPE
Examiner
Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
Prosecution Insights