DETAILED ACTION
Applicant’s arguments, filed on 02/18/2026, have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claims 1-20 are the current claims hereby under examination.
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 .
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.
Claims 1-4 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Silberzahn (US 20220174432) in further view of Lusted (US 9711060).
Regarding independent claim 1, Silberzahn teaches an ear-wearable electronic device (Abstract: “A customized in-ear hearing device includes a light source, photodetector, light emission window, and light transmission window.”) comprising:
a shell having an outer surface ([0003]: “a hearing device comprises a housing shell”);
a mounting void through the outer surface of the shell that exposes an internal volume of the shell ([0016]: “Electronic components of the hearing device can be attached to the faceplate/module and/or provided inside an inner volume enclosed by the housing. For example, a printed circuit board (PCB) including the electronic components can be provided inside the inner volume. Thus, the final assembly includes inserting the electronic components into an inner volume of the shell and covering a lateral opening of the shell with the faceplate attached to the shell”), the mounting void located at an ear-contacting region of the shell ([0020]: “the light emission window 112 is preferably located in the sealing zone of the in-ear device 104 (a portion of the shell 106 that is in contact with the ear canal 102, indicated in FIG. 1) such that no light dissipates to either free field or the residual volume. The sealing zone portion of the in-ear device 104 is preferably customized to the shape of the user's ear canal 102, thereby maximizing possible contact between the in-ear device 104 and the skin of the ear canal 102”).
a photoplethysmography sensor assembly having an optical transmission structure mounted in the mounting void ([0015]: “the disclosure relates to custom hearing devices comprising a housing shell configured to be at least partially inserted into an ear canal, where the housing shell is individually customized to the shape of the ear canal, capable of measuring photoplethysmogram (PPG) data”; [0004]: “the light emission window and the light detection window configured to allow transmission of light through a sidewall of the housing shell”), the optical transmission structure having a distal end exposed proximate the outer surface, the distal end of the optical transmission structure conforming to the outer surface of the shell at the ear-contacting region, the distal end in contact with ear tissue of a user of the ear-wearable electronic device during use ([0021]: “the light emission window 112 and the light detection window 116 are provided in the shell housing 106, in particular in a sidewall 107 of the shell housing 106. The light emission window 112 and the light detection window 116 extend through the sidewall 107. The sidewall 107 may enclose the interior of the shell housing 106, at least within the customized portion of the shell housing 106. The sidewall 107 may be customized to an individual shape of the ear canal 102, at least within the customized portion of the shell housing 106. An inner surface of the sidewall 107 may be oriented toward the interior of the shell housing 106. An outer surface of the sidewall 107 may be at least partially comprise the sealing zone of the shell 106. The outer surface may at least partially be oriented toward the ear canal when the shell 106 is inserted into the ear canal”; Abstract: “The light emission window and light detection window are located at a customized portion of the sidewall of the device that contacts the skin in the ear canal.”).
However, Silberzahn does not teach a shoulder formed contiguously with the shell extending into the internal volume of the shell with the photoplethysmography sensor assembly mounted against the shoulder, wherein the shoulder of the shell is positioned relative to the outer surface of the shell such that the distal end of the optical transmission structure is proximate to the outer surface.
Lusted discloses a biometric sensor ring for monitoring a subject. Specifically, Lusted teaches a shoulder formed contiguously with the device extending into the internal volume of the device; the photoplethysmography sensor assembly mounted against the shoulder and wherein the shoulder of the shell is positioned relative to the outer surface of the device such that the distal end of the optical transmission structure is proximate to the outer surface (Fig. 20, reference character 354; Column 19, lines 32-37: “upper shoulder/setting portion of the housing is configured with an adjustable connection depth interface with said lower band, whereby the sizing of the ring and thus contact pressure with said plurality of bio-sensors is controlled in response to adjusting this connection depth”. Silberzahn includes the PPG sensors in the in-ear device, however the sensor’s depth cannot be controlled or adjusted based on the user’s ear and the location of the device. Lusted discloses a PPG sensor in a ring with a shoulder structure. The shoulder structure allows the device to adjust the contact of the PPG sensor with the user’s skin, which can allow better contact between the sensor and the skin. This ensures that the sensor is picking up the strongest, most accurate measurement from the contact with the skin, which can improve the accuracy of the device.). Silberzahn and Lusted are analogous arts as they are both related to devices that use PPG sensors to measure physiological parameters of a user.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the shoulder from Lusted into the device from Silberzahn as it allows the device to control the depth of the PPG sensor, which ensures it has contact with the user’s skin. This is an important step, as the sensor needs to have close contact with the user’s skin to gather the correct, accurate measurements. The location of the shoulder within the shell would have been obvious as it allows the sensor to be in a position to make contact with the user’s skin in their ear.
Regarding claim 2, the Silberzahn/Lusted combination teaches the ear-wearable device of claim 1, wherein the outer surface of the shell corresponds uniquely to an ear geometry of the user (Silberzahn, [0003]: “at least a portion of the housing shell having a shape that is customized to a shape of a user's ear canal”).
Regarding claim 3, the Silberzahn/Lusted combination teaches the ear-wearable device of claim 1, wherein the photoplethysmography sensor assembly comprises a mating surface that fits up against the shoulder of the shell, contact between the mating surface and shoulder providing depth control for mounting of the photoplethysmography sensor assembly (Lusted, Fig. 20; Column 19, lines 32-37: “upper shoulder/setting portion of the housing is configured with an adjustable connection depth interface with said lower band, whereby the sizing of the ring and thus contact pressure with said plurality of bio-sensors is controlled in response to adjusting this connection depth”).
Regarding claim 4, the Silberzahn/Lusted combination teaches the ear-wearable device of claim 1, further comprising a skim coating over the distal end of the optical transmission structure that conforms to the outer surface of the shell at the ear-contacting region, the skim coating in contact with the ear tissue of the user during the use (Silberzahn, [0032]: “The indentation or through hole 900 can be coated, in particular between the sidewalls of the indentation or through hole 900 provided in the sidewall 107 of the shell 106, with an opaque lacquer to seal and allow transmission of light.”).
Regarding claim 14, the Silberzahn/Lusted combination teaches the ear-wearable device of claim 1, further comprising a flexible conformal covering over the distal end of the photoplethysmography sensor and portions of the outer surface of the shell surrounding the distal end (Silberzahn, [0028]: “as seen in the in-ear device 104 cross-section illustrated in FIG. 7, the waveguide 400, 402 is rigid or flexible light guide (e.g., made of silicone, glass fibers, and the like), in contact with and attached to the light source 114 or photodetector 118, and is freely guided through the in-ear device towards the window 112, 116 at the shell 106”).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over the Silberzahn/Lusted combination as applied to claim 1 above, and further in view of JP ‘997 (JP 2018527997). Citations to JP 2018527997 will refer to the English Machine Translation that accompanies this Office Action.
Regarding claim 5, the Silberzahn/Lusted combination teaches the ear-wearable device of claim 1.
However, the Silberzahn/Lusted combination does not teach wherein the ear-contacting region deviates from an ear geometry causing an interference fit between the ear-contacting region and an ear of the user.
JP ‘997 discloses a device to acquire diagnostic information from a user. Specifically, JP ‘997 teaches wherein the ear-contacting region deviates from an ear geometry causing an interference fit between the ear-contacting region and an ear of the user ([0392]: “FIG. 93C shows the connection with the main unit and the tapered ear canal fitting unit. This taper can help to provide an interference fit into the ear canal and / or to help reduce the movement and maintain the position”). Silberzahn and JP ‘997 are analogous arts as they are both related to in-ear devices used to monitor physiological parameters of a user.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the interference fit from JP ‘997 into the device from the Silberzahn/Lusted combination as it will allow the device to fit comfortably in the user’s ear and reduces the likelihood of the device moving or shifting, ensuring it measures the correct location and does not shift.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over the Silberzahn/Lusted combination as applied to claim 1 above, and further in view of Cohen (US 20190208304).
Regarding claim 6, the Silberzahn/Lusted combination teaches the ear-wearable device of claim 1.
However, the Silberzahn/Lusted combination does not explicitly state wherein the distal end of the optical transmission structure is in contact with a tragal wall of the user of the ear-wearable electronic device during the use.
Based on the anatomy of an ear, it is obvious that the structure can come in contact to the tragal wall. Additionally, Cohen discloses an apparatus for forming a custom earpiece. Specifically, Cohen teaches wherein the distal end of the optical transmission structure is in contact with a tragal wall of the user of the ear-wearable electronic device during the use ([0050]: “The outer ear 20 includes an ear canal 2 leading to an ear drum (not shown). An ear lobe 1 forms a lower portion of the outer ear 20 and a helix 6 extends from the ear lobe 1 to a top portion of the outer ear 20. The ear canal 2 is surrounded by the cavum conchae 3, the crus helix 5, the tragus 10, and the antitragus 12”). Silberzahn and Cohen are analogous arts as they are both devices related to in-ear devices which can be fit to the user’s ear.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to have a tragal wall as being part of the tissue to be contacted by the device because ear tissue is contacted and Cohen teaches what such tissue is involved in such contact.
Claims 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Silberzahn/Lusted as applied to claim 1 above, and further in view of Stewart (US 20180234781) and Colaizzi (US 20170095209).
Regarding claim 7, the Silberzahn/Lusted combination teaches the ear-wearable device of claim 1.
However, the Silberzahn/Lusted combination is silent on the material type of the shell.
Stewart discloses a hearing assistance device. Specifically, Stewart teaches wherein the shell comprises a rigid shell ([0034]: “the shell 20 can be made, at least in part, of any suitable material or materials, e.g., polymeric, metallic, or inorganic materials, and combinations thereof”). Silberzahn and Stewart are analogous arts as they are both devices related to in-ear devices which can be fit to the user’s ear.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the rigid shell material from Stewart into the Silberzahn/Lusted combination as the combination is silent on the type of material used, and Stewart discloses a suitable material in an analogous device.
However, the Silberzahn/Lusted/Stewart combination does not teach the ear-wearable device further comprising a compliant mounting structure between the photoplethysmography sensor and the mounting void through the rigid shell.
Lusted teaches a compliant mounting structure between the photoplethysmography sensor and the device structure (Column 9, lines 12-14 and 16-19: “one embodiment of the present disclosure utilizes a memory foam 256 that is similar to that used for ear plugs … the user inserts a finger and allows the foam to expand, as seen in FIG. 12B, against the upper part of the finger which places the lower surface firmly against the sensor section”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the foam structure from Lusted into the Silberzahn/Lusted/Stewart combination as it allows the sensor to be in the correct location and to allow the device to adjust the location dependent on the user’s ear anatomy.
However, the Silberzahn/Lusted/Stewart combination is silent on how much pressure is applied through the compliant mounting structure.
Colaizzi discloses a sensor mount for a reflective photo-optic sensor. Specifically, Colaizzi teaches the compliant mounting structure causing a pressure applied between the distal end of the optical transmission structure and the tissue to be within a predetermined pressure range during the use of the device ([0033]: “the foam back pad provides a contact force on the sensor to provide a contact force or contact pressure in the range of 60-180 mm Hg against a skin surface of a wearer”). Silberzahn and Colaizzi are analogous arts as they are both structures that use photo-optic sensors to measure physiological parameters of a user.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the predetermined pressure range from Colaizzi into the Silberzahn/Lusted/Stewart combination as the combination is silent on the amount of pressure required for the mounting structure, and Colaizzi discloses a suitable pressure range to maintain the correct location of the sensor without causing pain or incorrect measurements from too much pressure.
Regarding claim 8, into the Silberzahn/Lusted/Stewart/Colaizzi combination teaches the ear-wearable device of claim 7.
However, the Silberzahn/Lusted/Stewart/Colaizzi combination does not teach wherein the compliant mounting structure comprises a foam encapsulation around the optical transmission structure.
Colaizzi teaches wherein the compliant mounting structure comprises a foam encapsulation around the optical transmission structure ([0026]: “The sensor holder device 100 of FIG. 2 includes foam elements 106, 108 that cooperate together to both contain the sensor and position the sensor with respect to the adhesive layer in order to have a uniform application of force around the sensor against the skin to direct the sensor against the skin surface for obtaining a biological signal with good signal quality and integrity … The body element 108 is formed or machined from a sheet of foam material and is configured to define a cavity or recess 109 therein. The recess 109 is sized and configured for containing both the sensor 102 and a foam back pad 106 that lies behind the sensor 102 in accordance with an embodiment of the invention”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the mounting structure encapsulating the optical transmission structure from Colaizzi into the Silberzahn/Lusted/Stewart/Colaizzi combination as it allows the sensor to have adequate connection to the skin, ensuring the most accurate measurement is recorded.
Regarding claim 9, the Silberzahn/Lusted/Stewart/Colaizzi combination teaches the ear-wearable device of claim 7.
However, the Silberzahn/Lusted/Stewart/Colaizzi combination is silent on the manufacturing steps of the compliant mounting structure.
Stewart teaches wherein the compliant mounting structure comprises a 3-D printed first material at the ear-contacting region that is formed integrally with a 3-D printed second material of the shell that is stiffer than the first material ([0046]: “The shell 20 and the frame 50 can be manufactured using any suitable technique or techniques, e.g., injection molding, insert molding, 3D printing, etc”; Abstract: “an indentation hardness value of the frame is greater than an indentation hardness value of the shell”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the 3D-printing step from Stewart into the device from the Silberzahn/Lusted/Stewart/Colaizzi combination as the combination is silent on the manufacturing process, and Stewart provides a suitable manufacturing process in an analogous device.
Claims 15-16 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Silberzahn, in further view of Lusted and Colaizzi.
Regarding independent claim 15, Silberzahn teaches an ear-wearable electronic device (Abstract: “A customized in-ear hearing device includes a light source, photodetector, light emission window, and light transmission window.” ) comprising:
a shell having an outer surface ([0003]: “a hearing device comprises a housing shell”);
a mounting void through the outer surface of the shell that exposes an internal volume of the shell ([0016]: “Electronic components of the hearing device can be attached to the faceplate/module and/or provided inside an inner volume enclosed by the housing. For example, a printed circuit board (PCB) including the electronic components can be provided inside the inner volume. Thus, the final assembly includes inserting the electronic components into an inner volume of the shell and covering a lateral opening of the shell with the faceplate attached to the shell”), the mounting void located at an ear-contacting region of the shell ([0020]: “the light emission window 112 is preferably located in the sealing zone of the in-ear device 104 (a portion of the shell 106 that is in contact with the ear canal 102, indicated in FIG. 1) such that no light dissipates to either free field or the residual volume. The sealing zone portion of the in-ear device 104 is preferably customized to the shape of the user's ear canal 102, thereby maximizing possible contact between the in-ear device 104 and the skin of the ear canal 102”);
a biometric sensor assembly having a distal end exposed proximate the outer surface ([0015]: “the disclosure relates to custom hearing devices comprising a housing shell configured to be at least partially inserted into an ear canal, where the housing shell is individually customized to the shape of the ear canal, capable of measuring photoplethysmogram (PPG) data”; [0004]: “the light emission window and the light detection window configured to allow transmission of light through a sidewall of the housing shell”), the distal end of the biometric sensor conforming to the outer surface of the shell at the ear-contacting region, the distal end in contact with ear tissue of a user during use ([0021]: “the light emission window 112 and the light detection window 116 are provided in the shell housing 106, in particular in a sidewall 107 of the shell housing 106. The light emission window 112 and the light detection window 116 extend through the sidewall 107. The sidewall 107 may enclose the interior of the shell housing 106, at least within the customized portion of the shell housing 106. The sidewall 107 may be customized to an individual shape of the ear canal 102, at least within the customized portion of the shell housing 106. An inner surface of the sidewall 107 may be oriented toward the interior of the shell housing 106. An outer surface of the sidewall 107 may be at least partially comprise the sealing zone of the shell 106. The outer surface may at least partially be oriented toward the ear canal when the shell 106 is inserted into the ear canal”; Abstract: “The light emission window and light detection window are located at a customized portion of the sidewall of the device that contacts the skin in the ear canal.”).
However, Silberzahn does not disclose further comprising a compliant mounting structure between the photoplethysmography sensor and the mounting void, the compliant mounting structure causing a pressure applied between the distal end of the optical transmission structure and the ear tissue to be within a predetermined pressure range during the use of the ear-wearable device.
Lusted teaches a compliant mounting structure between the photoplethysmography sensor and the device structure (Column 9, lines 12-14 and 16-19: “one embodiment of the present disclosure utilizes a memory foam 256 that is similar to that used for ear plugs … the user inserts a finger and allows the foam to expand, as seen in FIG. 12B, against the upper part of the finger which places the lower surface firmly against the sensor section”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the foam structure from Lusted into the Silberzahn/Lusted combination as it allows the sensor to be in the correct location and to allow the device to adjust the location dependent on the user’s ear anatomy.
However, the Silberzahn/Lusted combination is silent on how much pressure is applied through the compliant mounting structure.
Colaizzi discloses a sensor mount for a reflective photo-optic sensor. Specifically, Colaizzi teaches the compliant mounting structure causing a pressure applied between the distal end of the optical transmission structure and the tissue to be within a predetermined pressure range during the use of the device ([0033]: “the foam back pad provides a contact force on the sensor to provide a contact force or contact pressure in the range of 60-180 mm Hg against a skin surface of a wearer”). Silberzahn and Colaizzi are analogous arts as they are both structures that use photo-optic sensors to measure physiological parameters of a user.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the predetermined pressure range from Colaizzi into the Silberzahn/Lusted combination as the combination is silent on the amount of pressure required for the mounting structure, and Colaizzi discloses a suitable pressure range to maintain the correct location of the sensor without causing pain or incorrect measurements from too much pressure.
Regarding claim 16, the Silberzahn/Lusted/Colaizzi combination teaches the ear-wearable device of claim 15, wherein the outer surface of the shell corresponds uniquely to an ear geometry of the user of the ear-wearable device (Silberzahn, [0003]: “at least a portion of the housing shell having a shape that is customized to a shape of a user's ear canal”).
Regarding claim 19, the Silberzahn/Lusted/Colaizzi combination teaches the ear-wearable device of claim 15.
However, the Silberzahn/Lusted/Colaizzi combination does not teach wherein the compliant mounting structure comprises a foam encapsulation around the optical transmission structure.
Colaizzi teaches wherein the compliant mounting structure comprises a foam encapsulation around the optical transmission structure ([0026]: “The sensor holder device 100 of FIG. 2 includes foam elements 106, 108 that cooperate together to both contain the sensor and position the sensor with respect to the adhesive layer in order to have a uniform application of force around the sensor against the skin to direct the sensor against the skin surface for obtaining a biological signal with good signal quality and integrity … The body element 108 is formed or machined from a sheet of foam material and is configured to define a cavity or recess 109 therein. The recess 109 is sized and configured for containing both the sensor 102 and a foam back pad 106 that lies behind the sensor 102 in accordance with an embodiment of the invention”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the mounting structure encapsulating the optical transmission structure from Colaizzi into the Silberzahn/Lusted/Colaizzi combination as it allows the sensor to have adequate connection to the skin, ensuring the most accurate measurement is recorded.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over the Silberzahn/Lusted/Colaizzi combination as applied to claim 15 above, and further in view of JP ‘997 (JP 2018527997).
Regarding claim 17, the Silberzahn/Lusted/Colaizzi combination teaches the ear-wearable device of claim 15.
However, the Silberzahn/Lusted/Colaizzi combination does not teach wherein the ear-contacting region deviates from an ear geometry causing an interference fit between the ear-contacting region and an ear of the user.
JP ‘997 teaches wherein the ear-contacting region deviates from an ear geometry causing an interference fit between the ear-contacting region and a surface of the user's ear ([0392]: “FIG. 93C shows the connection with the main unit and the tapered ear canal fitting unit. This taper can help to provide an interference fit into the ear canal and / or to help reduce the movement and maintain the position”). Silberzahn and JP ‘997 are analogous arts as they are both related to in-ear devices used to monitor physiological parameters of a user.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the interference fit from JP ‘997 into the device from the Silberzahn/Lusted/Colaizzi combination as it will allow the device to fit comfortably in the user’s ear and reduces the likelihood of the device moving or shifting, ensuring it measures the correct location and does not shift.
Claims 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over the Silberzahn/Lusted/Stewart/Colaizzi combination as applied to claim 7 above, and further in view of Goldstein (US 20170112671) and Norgard (CN 108209933). Citations to CN 108209933 will refer to the English Machine Translation that accompanies this Office Action.
Regarding claim 10, the Silberzahn/Lusted/Stewart/Colaizzi combination teaches the ear-wearable device of claim 7.
However, the Silberzahn/Lusted/Stewart/Colaizzi combination does not teach wherein the compliant mounting structure comprises an elastomer boot that surrounds the optical transmission structure, wherein the elastomer boot further comprises: a glue pocket wing on a first side of the elastomer boot; and a snap finger on a second side opposed to the first side, and wherein the shell further comprises interface features formed contiguously with the shell extending into the internal volume of the shell, the interface features including: a snap window having a snap void through which the snap finger attaches; and a bonding surface to which the glue pocket wing is attached.
Goldstein discloses a physiological monitor. Goldstein teaches wherein the compliant mounting structure comprises an elastomer boot that surrounds the optical transmission structure ([0176]: “Preferably, the can be made of flexible material such as elastomeric material to enable a snug and sealing fit to the opening as the actuator is actuated.”). Silberzahn and Goldstein are analogous arts as they are both devices used to monitor physiological parameters of a user.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the elastomer boot from Goldstein into the Silberzahn/Lusted/Stewart/Colaizzi combination as it allows the optical transmission structure to be covered by a flexible material, which can allow it to fit into the device and the ear of the user better, and give more structure to the transmission structure.
However, the Silberzahn/Stewart/Colaizzi/Goldstein combination is silent on the connection structure of the elastomer boot.
Norgard discloses an ear probe for hearing testing. Specifically, Norgard teaches wherein the elastomer boot further comprises: a glue pocket wing on a first side of the elastomer boot; and a snap finger on a second side opposed to the first side, and wherein the shell further comprises interface features formed contiguously with the shell extending into the internal volume of the shell, the interface features including: a snap window having a snap void through which the snap finger attaches; and a bonding surface to which the glue pocket wing is attached ([0021]: “the combined structure is "snap" engagement with shell structure after assembly, after the electric component such as lead is soldered to a PCB. Thus, the components may be by glue or other suitable means (such as by the PCB and the element to be fixed to PCB mechanically fixed connection element and/or structure) is tightly fixed in the shell.”). Silberzahn, Stewart, Goldstein, and Norgard are analogous arts as they are all related to devices used to measure health parameters of a user.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the connection structure from Norgard into the Silberzahn/Lusted/Stewart/Colaizzi/Goldstein combination as the combination is silent on the connection structure and Norgard provides a suitable connection structure in an analogous device.
Regarding claim 11, the Silberzahn/Stewart/Colaizzi/Goldstein/Norgard combination teaches the ear-wearable device of claim 10, wherein the interface features further comprise one or more rigid snap fingers through which one or more edges of the elastomer boot squeeze through, the one or more rigid snap fingers retaining the elastomer boot in the mounting void (Norgard, [0021]: “the combined structure is "snap" engagement with shell structure after assembly, after the electric component such as lead is soldered to a PCB. Thus, the components may be by glue or other suitable means (such as by the PCB and the element to be fixed to PCB mechanically fixed connection element and/or structure) is tightly fixed in the shell.”).
Claims 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over the Silberzahn/Lusted/Stewart/Colaizzi combination as applied to claim 7 above, and further in view of Goldstein and Burwinkel (WO 2021188360).
Regarding claim 12, the Silberzahn/Stewart/Colaizzi combination teaches the ear-wearable device of claim 7.
However, the Silberzahn/Lusted/Stewart/Colaizzi combination does not teach further comprising a pressure sensor coupled between the shell and the photoplethysmography sensor, the pressure sensor operable to measure or estimate the pressure applied between the distal end of the optical transmission structure and the ear tissue, a signal generated by the pressure sensor coupled to a processor of the ear-wearable device.
Goldstein teaches further comprising a pressure sensor coupled between the shell and the photoplethysmography sensor ([0059]: “Exemplary physiological and environmental sensors that may be incorporated into a Bluetooth® or other type of earpiece module include, but are not limited to accelerometers, auscultatory sensors, pressure sensors, humidity sensors, color sensors, light intensity sensors, pulse oximetry sensors, pressure sensors, etc”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the pressure sensor from Goldstein into the Silberzahn/Lusted/Stewart/Colaizzi combination as it allows the device to take more measurements, which can provide more information to the user and create a more accurate assessment of the user’s health condition.
However, the Silberzahn//Lusted/Stewart/Colaizzi/Goldstein combination does not teach the pressure sensor operable to measure or estimate the pressure applied between the distal end of the optical transmission structure and the ear tissue, a signal generated by the pressure sensor coupled to a processor of the ear-wearable device.
Burwinkel discloses a posture detection using hearing instruments. Specifically, Burwinkel teaches the pressure sensor operable to measure or estimate the pressure applied between the distal end of the optical transmission structure and the ear tissue ([0037]: “Furthermore, in the example of FIG. 2, sensors 114A include an inertial measurement unit (IMU) 226 that is configured to generate data regarding the motion of hearing instrument 102 A. IMU 226 may include a set of sensors. For instance, in the example of FIG. 2, IMU 226 includes one or more accelerometers 228, a gyroscope 230, a magnetometer 232, combinations thereof, and/or other sensors for determining the motion of hearing instrument 102A. Furthermore, in the example of FIG. 2, hearing instrument 102Amay include one or more additional sensors 236. Additional sensors 236 may include a photoplethysmography (PPG) sensor, blood oximetry sensors, blood pressure sensors, electrocardiograph (EKG) sensors, body temperature sensors, electroencephalography (EEG) sensors, environmental temperature sensors, environmental pressure sensors, environmental humidity sensors, skin galvanic response sensors, and/or other types of sensors.”). Silberzahn, Stewart, Goldstein, and Burwinkel are analogous arts as they are all related to devices used to measure health parameters of a user.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the pressure measurements from Burwinkel into the Silberzahn/Lusted/Stewart/Colaizzi/Goldstein combination as it allows the device to take more measurements, which can provide more information to the user and create a more accurate assessment of the user’s health condition.
The Silberzahn/Lusted/Stewart/Colaizzi/Goldstein/Burwinkel combination teaches a signal generated by the pressure sensor coupled to a processor of the ear-wearable device (Silberzahn, [0035]: “the light source 114 and the photodetector 118 are electronically connected to sensor processing circuitry, which may include a processor, discrete circuit components, and the like”).
Regarding claim 13, the Silberzahn/Lusted/Stewart/Colaizzi/Goldstein/Burwinkel combination teaches the ear-wearable device of claim 12.
However, the Silberzahn/Lusted/Stewart/Colaizzi/Goldstein/Burwinkel combination does not teach wherein the signal generated by the pressure sensor is used to perform at least one of: detecting motion artifacts and modify audio processing by the ear-wearable device based on the motion artifacts; and alerting the user when the pressure applied between the distal end of the optical transmission structure and the ear tissue is too low.
Goldstein teaches wherein the signal generated by the pressure sensor is used to perform at least one of: detecting motion artifacts and modify audio processing by the ear-wearable device based on the motion artifacts; and alerting the user when the pressure applied between the distal end of the optical transmission structure and the ear tissue is too low ([0131]: “The communication module may utilize audible or visible alerts if the user is meeting their physiological targets or exceeding safe physiological limits”; [0132]: “an entertaining or aggravating sound or song can be used to alert the user to favorable or unfavorable personal health and environmental factors occurring in real-time”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the alert from Goldstein into the Silberzahn/Lusted/Stewart/Colaizzi/Goldstein/Burwinkel combination as it allows the device to alert the user of any issues, which can ensure the proper measurements are being taken.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over the Silberzahn/Lusted/Colaizzi combination as applied to claim 15 above, and further in view of Cohen.
Regarding claim 18, the Silberzahn/Lusted/Colaizzi combination teaches the ear-wearable device of claim 15.
However, the Silberzahn/Lusted/Colaizzi combination does not explicitly state wherein the distal end of the optical transmission structure is in contact with a tragal wall of the user of the ear-wearable electronic device during the use.
Based on the anatomy of an ear, it is obvious that the structure can come in contact to the tragal wall. Additionally, Cohen discloses an apparatus for forming a custom earpiece. Specifically, Cohen teaches wherein the distal end of the optical transmission structure is in contact with a tragal wall of the user of the ear-wearable electronic device during the use ([0050]: “The outer ear 20 includes an ear canal 2 leading to an ear drum (not shown). An ear lobe 1 forms a lower portion of the outer ear 20 and a helix 6 extends from the ear lobe 1 to a top portion of the outer ear 20. The ear canal 2 is surrounded by the cavum conchae 3, the crus helix 5, the tragus 10, and the antitragus 12”). Silberzahn and Cohen are analogous arts as they are both devices related to in-ear devices which can be fit to the user’s ear.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to have a tragal wall as being part of the tissue to be contacted by the device because ear tissue is contacted and Cohen teaches what such tissue is involved in such contact.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over the Silberzahn/Lusted/Colaizzi combination as applied to claim 15 above, and further in view of Armstrong (US 20160029125).
Regarding claim 20, the Silberzahn/Lusted/Colaizzi combination teaches the ear-wearable device of claim 15.
However, the Silberzahn/Lusted/Colaizzi combination does not teach further comprising a fabric covering the distal end of the biometric sensor and portions of the outer surface of the shell surrounding the distal end.
Armstrong discloses a system for anticipating activity using earphones with biometric sensors. Specifically, Armstrong teaches further comprising a fabric covering the distal end of the biometric sensor and portions of the outer surface of the shell surrounding the distal end ([0040]: “The tip may be made with softer materials such as rubber, silicone, fabric, or other materials as would be appreciated by one of ordinary skill in the art.”). Silberzahn and Armstrong are analogous arts as they are all related to devices used to measure health parameters of a user.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the fabric covering from Armstrong into the Silberzahn/Lusted/Colaizzi combination as it allows the device to have a protective cover, and allows the cover to be removed and replaced if necessary.
Response to Arguments
All of applicant’s argument regarding the rejections and objections previously set forth have been fully considered and are persuasive unless directly addressed subsequently.
Applicant's arguments filed 02/18/2026 have been fully considered but they are not persuasive. Applicant argues that there is no explanation of how the ring-sized mechanism from Lusted would be incorporated into the ear canal shell from Silberzahn. However, as stated in the 103 rejection above, the entire ring-shaped mechanism from Lusted is not being incorporated into the device from Silberzahn, only the shoulder used to adjust the depth of the sensor, which would be integrated into the sensor already present in Silberzahn.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Applicant also argues that the shoulder from Lusted is not the same as the shoulder from the claimed invention, however, the shoulder structure from Lusted allows the sensor to be moved closer to the location of the skin, which when incorporated into the device from Silberzahn, allows for depth control, which performs the same function as the shoulder in the claims.
Applicant argues that Lusted does not teach the shoulder being contiguous with the shell or extending into the internal volume of the shell, however this is taught by the combination of Silberzahn and Lusted, since the structure surrounding the sensor from Lusted is incorporated into the location of the sensor from Silberzahn, which therefore would place it as being contiguous with the shell and positioned to extend into the internal volume of the shell.
Applicant also argues that Lusted does not teach the compliant mounting structure. However, as stated above in the 103 rejection, Lusted teaches including the memory foam between the user’s skin and the device, which can include the mounting void. Additionally, Applicant argues that Lusted’s memory foam presses the finger towards the sensor and not the sensor towards the skin, however pushing the sensor towards the skin is not a limitation required in the claims, therefore this argument is not applicable. The complaint structure is only required to cause pressure between the sensor and the skin tissue, which is being taught by Colaizzi in the rejection, not Lusted.
Applicant also argues that the mounting structure from Colaizzi is not equivalent to the mounting structure from claim 15. However, both mounting structures are foam structures used to keep a sensor in contact with a user’s skin, therefore they are similar structures.
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/E.K.M./Examiner, Art Unit 3791
/MATTHEW KREMER/Primary Examiner, Art Unit 3791
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