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 cancellation of claims 1-9 and the addition of new claims 10-25 in the response filed 10/24/25 are acknowledged.
Claims 10-25 are now pending in the application and are examined below.
Election/Restrictions
Applicant’s election without traverse of Group II, figs. 4-6B in the reply filed on 10/24/25 is acknowledged.
Claims 10-25 are drawn to the elected species and are thus examined below.
Claim Objections
Claims 10, 11, and 16 are objected to because of the following informalities:
“including at a” in claim 10, line 7 --including a--
“the circuitry are in the form of a ring-shaped member” in claim 11, line 2 should be amended to recite --the circuitry form a ring-shaped member--
“hyponea” in claim 16, line 2 should be amended to recite --hypopnea--
Appropriate correction is required.
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 22 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.
Regarding claim 22, the term “substantially” in line 2 is a relative term which renders the claim indefinite. The term “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claim 22 is rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Regarding claim 22, the claim positively recites the wearer’s skin in line 3. Language such as “configured” or “adapted” is suggested to avoid claiming a human organism.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 10-13, 15-18, and 23 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by von Badinski et al. US 2015/0220109 A1.
Regarding claim 10, von Badinski discloses a wearable sensor arrangement 100 configured to be worn around a body part of a wearer (fig. 1A and [0159]-[0160], [0162], WCD 110 is a fitness, physical activity, and biological data monitoring device with sensor modules 220; [0155], the WCD can be in the form of a wrist band), comprising:
a first layer having an inner surface configured to contact the wearer’s skin, the first layer having an opening (fig. 1B and [0160], the WCD 110 has an interior wall with an interior window 130, and the WCD 110 makes constant contact with skin);
a second layer spaced away from the first layer and having an outer surface configured to face away from the wearer’s skin (fig. 1A and [0160], the WCD 110 has an exterior wall, and the exterior surface having window 120 is considered the outer surface that would face away from the skin when worn; fig. 4 and [0187], [0189], WCD 410 (“e.g., WCD 110”, indicating that WCD 110 and 410 are equivalent) receives flexible circuit 415 between its inner and outer walls such that elements of the circuit 415 align with the windows; thus, the inner and outer walls are spaced from each other); and
circuitry 415 including a plurality of sensors configured to sense physiological parameters of the wearer (fig. 2 and [0187], circuit 415 may take the form of a printed flexible circuit and may include modules 210-270, which include sensor module 220; [0167], sensor modules 220 can include those related to biological sign monitoring), the plurality of sensors 220 including at least a first sensor 320a-d aligned with the opening 130 (fig. 3B and [0167], sensors 320a-d are positioned in a way that faces the interior window 130, which can be seen in the figure), wherein the circuitry 415, as seen in cross section, being provided between the first and second layers (fig. 4 and [0189], WCD 410 receives flexible circuit 415 between its inner and outer walls, as the circuit 415 is inserted through the edge).
Regarding claim 11, von Badinski discloses the first layer, the second layer and the circuitry 415 being in the form of a ring-shaped member configured to be worn by the wearer (fig. 4 shows the ring shaped nature of the layers and circuitry; [0155], the WCD can be in the form of a wrist band).
Regarding claim 12, von Badinski discloses the ring-shaped member comprising headgear and/or a wrist band ([0155], the WCD can be in the form of a wrist band).
Regarding claim 13, von Badinski discloses the plurality of sensors 220 comprising an accelerometer, gyroscope, a pulse oximeter, an EMG/EOG, EEG, and/or PPG ([0189], the biological feedback sensors may include pulse oximetry).
Regarding claim 15, von Badinski discloses the circuitry 415 including a battery 280 to power the plurality of sensors 220 (fig. 2 and [0162], battery 280 provides electrical power to the WCD 110, which includes its sensors 220).
Regarding claim 16, von Badinski discloses the plurality of sensors 220 being configured to generate data indicative of apnea, temperature, hypopnea, sleep stage, blood oxygen, heart rate, sleeping position and/or body movement of the wearer PPG ([0189], the biological feedback sensors may include pulse oximetry and temperature sensors).
Regarding claim 17, von Badinski discloses the circuitry 415 comprising an actuator to provide a sensory stimulus to the wearer ([0183], the WCD can include polymer or piezo actuators to provide haptic or physical feedback, or audible feedback).
Regarding claim 18, von Badinski discloses the actuator being configured to generate vibration, noise or tactile stimulus to the wearer ([0183], the WCD can include polymer or piezo actuators to provide haptic or physical feedback, or audible feedback).
Regarding claim 23, von Badinski discloses the outer surface including an opening 120 to align with one component 350 of the circuitry 415 (fig. 3A and [0173], antenna/communication module 350 is aligned with exterior window 120), the opening 120 in the outer surface being offset from and not aligned with the opening 130 in the inner surface (since the windows 120 and 130 are on the outer and inner walls, respectively, the can be considered offset from and not aligned with each other, as they are not on the same wall).
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.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over von Badinski et al. US 2015/0220109 A1 in view of Patel et al. US 11,751,790 B1.
Regarding claim 14, von Badinski discloses the claimed invention as discussed above.
Von Badinski is silent on the circuitry including a ground electrode and a reference electrode.
However, Patel teaches an analogous device 150 for measuring physiological signals (fig. 1 and col. 2, lines 57-61), the circuitry 300 including a ground electrode 306 and a reference electrode 304 (col. 5, line 63-col. 6, line 5).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the circuitry of von Badinski to include a ground electrode and a reference electrode, as taught by Patel, to measure physiological signals (col. 5, lines 63-64).
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over von Badinski et al. US 2015/0220109 A1 in view of Mirov et al. US 2022/0015703 A1.
Regarding claim 19, von Badinski discloses the claimed invention as discussed above.
Von Badinski is silent on the actuator being configured to generate white or pink noise, a binaural beat or localized temperature change to the wearer.
However, Mirov teaches an analogous sensing system for the body ([0003], sensing systems for processing physiological signals) comprising an analogous actuator configured to generate white or pink noise ([0062], module 818 may actuate the speaker 836 to provide audible cues including white noise to provide aural feedback to the wearer), a binaural beat or localized temperature change to the wearer.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the actuator of von Badinski to be configured to generate white or pink noise, a binaural beat or localized temperature change to the wearer, as taught by Mirov, as white noise is a well tolerated form of sound that can alert users without discomfort.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over von Badinski et al. US 2015/0220109 A1 in view of Stanfield et al. US 2016/0317383 A1.
Regarding claim 20, von Badinski discloses the claimed invention as discussed above.
Von Badinski is silent on the circuitry including a processor configured to receive signals from the plurality of sensors and generate control signals to control the actuator.
However, Stanfield teaches an analogous wearable sensor system ([0030], wearable device to collect sensory related data) comprising circuitry including a processor configured to receive signals from the plurality of sensors and generate control signals to control the actuator ([0030], the control center has a processor with a transceiver that receives sensory related data, and in response, it sends activating signals to actuate sensor devices to activate sensory events).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have provided the circuitry of von Badinksi with a processor configured to receive signals from the plurality of sensors and generate control signals to control the actuator, as taught by Stanfield, to allow the state of the wearer to determine the necessary stimulation, providing greater accuracy and customization.
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over von Badinski et al. US 2015/0220109 A1 in view of Gopalakrishnan et al. US 2015/0164349 A1.
Regarding claim 21, von Badinski discloses the claimed invention as discussed above.
Von Badinski further discloses the circuitry 415 being configured to wirelessly communicate with an external computing device and provide feedback to the wearer regarding sleep quality or health levels ([0184], the WCD 110 can be used with a mobile device for data communication; fig. 10 shows a user interface displaying the readings (i.e., live feedback regarding health levels) on the mobile device; [0174], communication module 250 allows for wireless data transmission).
Von Badinski is silent on the circuitry being configured to provide recommendations for improving the wearer’s health.
However, Gopalakrishnan teaches an analogous wearable monitoring device 1400 (fig. 14 and [0116]) comprising circuitry configured to provide recommendations for improving the wearer’s health (fig. 12 and 12A and [0113], the mobile app has a page for goals and recommendations).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the circuitry that is configured to wirelessly communicate with an external computing device of von Badinski to be configured to provide recommendations for improving the wearer’s health, as taught by Gopalakrishnan, to enhance the wearer’s health based on current physiological metrics.
Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over von Badinski et al. US 2015/0220109 A1 in view of Young et al. US 2020/0107734 A1.
Regarding claim 22, von Badinski discloses the claimed invention as discussed above.
Von Badinski is silent on a portion of the at least one first sensor and the inner surface surrounding the opening forming a substantially flat surface, in cross section, that is in contact with the wearer’s skin.
However, Young teaches an analogous vital monitoring device 102 (figs. 1 and 2 and [0002]) comprising a portion of an analogous at least one first sensor 112-120 and the inner surface surrounding the opening 122 forming a substantially flat surface, in cross section, that is in contact with the wearer’s skin (fig. 2 and [0040], sensor module 102 includes apertures 122 to support sensors 112-120, and the sensors may be flush with the surface 108 to contact the patient’s skin).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the at least one first sensor on the inner surface of von Badinski such that a portion of the at least one first sensor and the inner surface surrounding the opening form a substantially flat surface, in cross section, that is in contact with the wearer’s skin, as taught by Young, to provide a smooth inner surface so that the device is comfortable to wear on the skin while still allowing for monitoring.
Claim(s) 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over von Badinski et al. US 2015/0220109 A1 in view of Gopalakrishnan et al. US 2015/0164349 A1 further in view of Chausiaux et al. US 2017/0311886 A1.
Regarding claim 24, von Badinski discloses the claimed invention as discussed above.
Von Badinski further discloses the circuitry 415 including a battery configured to power the circuitry 415 (fig. 2 and [0162], battery 280 provides electrical power to the WCD 110, which includes its circuitry 415), wherein the plurality of sensors 220 are configured to generate data related to sleep stage, blood oxygen, heart rate, skin temperature and physical movement of the wearer ([0169], the sensor modules 220 can enable the WCD 110 to perform multiple functions, including sleep monitor (which is related to sleep stage), pulse oximetry, heart rate sensor, skin temperature, and pedometer), wherein the processor 210 is configured to collect and process signals from the plurality of sensors 220 ([0164], the processor module 210 is coupled to all modules including sensor module 220 for data and control signal transmission), and wherein the circuitry 415 is configured to wirelessly communicate with an external computing device to provide feedback to the wearer regarding sleep quality or health levels ([0184], the WCD 110 can be used with a mobile device for data communication; fig. 10 shows a user interface displaying the readings (i.e., live feedback regarding health levels) on the mobile device; [0174], communication module 250 allows for wireless data transmission).
Von Badinski is silent on the circuitry being configured to provide recommendations for improving health of the wearer.
However, Gopalakrishnan teaches an analogous wearable monitoring device 1400 (fig. 14 and [0116]) comprising circuitry configured to provide recommendations for improving health of the wearer (fig. 12 and 12A and [0113], the mobile app has a page for goals and recommendations).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the circuitry that is configured to wirelessly communicate with an external computing device of von Badinski to be configured to provide recommendations for improving health of the wearer, as taught by Gopalakrishnan, to enhance the wearer’s health based on current physiological metrics.
Von Badinski in view of Gopalakrishnan is silent on the circuitry including a transceiver for the wireless communication.
However, Chausiaux teaches an analogous sensing system for the body (fig. 5a and [0002]) comprising a transceiver for the wireless communication ([0049], transceiver 29 can transmit data to another device such as a smartphone).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the circuitry of von Badinski in view of Gopalakrishnan to include a transceiver for the wireless communication, as taught by Chausiaux, to allow for convenient transmission of data.
Claim(s) 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over von Badinski et al. US 2015/0220109 A1 in view of Gopalakrishnan et al. US 2015/0164349 A1 further in view of Chausiaux et al. US 2017/0311886 A1 and Mirov et al. US 2022/0015703 A1.
Regarding claim 25, von Badinski in view of Gopalakrishnan further in view of Chausiaux discloses the claimed invention as discussed above.
Von Badinski further teaches the plurality of sensors 220 including a blood oxygen sensor, a temperature sensor, and an accelerometer ([0169], the sensor modules 220 can enable the WCD 110 to perform multiple functions, including pulse oximetry, skin temperature, and an accelerometer).
Von Badinski in view of Gopalakrishnan further in view of Chausiaux is silent on the sensors including a PPG sensor.
However, Mirov teaches an analogous sensing system for the body ([0003], sensing systems for processing physiological signals) comprising a PPG sensor ([0045], the circuit components 518 may include a PPG sensor, among other sensors).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have provided the plurality of sensors of von Badinski in view of Gopalakrishnan further in view of Chausiaux with a PPG sensor, as taught by Mirov, to further evaluate biometrics of the wearer, such as heart rhythm.
Conclusion
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/MICHELLE J LEE/ Primary Examiner, Art Unit 3786