DETAILED ACTION
This action is pursuant to the claims filed on December 9, 2024. Claims 1-20 are pending. A first action on the merits of claims 1-20 is as follows.
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 . 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 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.
Claim Objections
Claims 3-4 are objected to because of the following informalities: Claim 4 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 3. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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 16 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 pre-AIA the applicant regards as the invention.
Claim 16 recites “the sleep score”. However, there is insufficient antecedent basis for said limitation.
Appropriate correction is required.
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Walter et al. (hereinafter ‘Walter’, U.S. PGPub. No. 2010/0234697), in view of Toth et al. (hereinafter ‘Toth’, U.S. PGPub. No. 2015/0351690), and further in view of Woodroof (U.S. Pat. No. 4,303,712).
In regards to independent claim 1, Walter discloses a wearable biopatch device (Fig. 1A, 1B, 2A, 2B disclosing a monitoring patch 100, 150, 200 and 250, respectively) configured for sleep monitoring ([0048]: measuring sleep duration and sleep cycle), the device comprising:
an adhesive substrate ([0034], [0052], [0055]: the monitoring patch of embodiments Figs. 1A, 1B, 2A and 2B may be a flexible substrate including an adhesive for attaching the monitoring patch to, e.g., a subject’s forehead) having an inner surface (surface configured to contact the skin) and an outer surface (surface opposite to the inner surface);
an integrated sensor system ([0039] & [0041]: the monitoring patch includes a plurality of electrodes 252, 254, 256, 258, 260 as shown in Fig. 2C and an electronic apparatus, e.g. 206 in Fig. 2A, comprising microcontroller, microprocessors, EEG apparatus, power management units, ADC, DSP, I/O ports, etc.) coupled to the inner surface of the adhesive substrate (the plurality of electrodes are disposed on the inner surface of the adhesive substrate; note that all elements of the electronic apparatus is generally ‘coupled to’ (e.g. directly or indirectly) to the inner surface of the flexible substrate), the integrated sensor system comprising a plurality of electrodes placed in predetermined locations and electrical connections between the plurality of electrodes (see Fig. 2C, [0042]: the I/O ports of the EEG apparatus of the apparatus 206 is electrically coupled to one or more electrodes each transmitting an electrical signal), including at least three electrodes configured for EEG sensing ([0058]: electrodes 254 in Fig. 2C configured for EEG sensing) and two electrodes ([0058]: EOG electrodes 258 in Fig. 2C);
at least one circuit configured for wireless data transmission disposed on a portion of the substrate ([0082]: wireless transmission of the recorded neural activity data between the monitoring patch and an analysis system inherently requires a wireless transmitter or circuit incorporated on the monitoring patch in communication with the memory).
However, Walter does not disclose an additional EOG electrode to arrive at three EOG electrodes. It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Walter and provide an additional EOG electrode, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8. In addition, Walker discloses that providing an additional electrode provides redundancy in case an electrode loses contact or an electrode malfunction, etc. or as a reference electrode ([0059]).
However, Walter does not disclose a hypoallergenic silicone adhesive substrate as claimed.
Toth teaches a medical patch (patch 1105 in Figs. 11a-11b) comprising an adhesive layer (a patient facing adhesive layer 1155, [0352]; [0193] & [0198]: the adhesive layer is a silicone adhesive) The Examiner notes that the silicone type adhesive is inherently a hypoallergenic material or results in less likely to cause allergic reaction compared to latex or rubber. In addition, Toth teaches providing a substrate above the adhesive layer (substrate 1109 in Fig. 11a; [0198]-[0199]: the substrate is coupled to the thin adhesive layer) to provide stretchability when attached to a skin of a user without nicking, curling or lifting from the skin surface ([0190]). Given that Walter is silent as to the specific material of the adhesive layer, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to substitute the adhesive layer of Walter with a silicone adhesive as taught by Toth, which inherently results in less allergic reaction compared to other allergic prone materials, as the equivalent of various materials such as acrylic adhesive, silicone adhesive, hot melt pressure sensitive adhesive, hydrogel adhesive for attaching a medical patch on to a skin involves routine skill in the art ([0193]). Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to provide a substrate above the modified hypoallergenic silicone adhesive substrate as doing so provides 1) support to one or more interconnects, sensors and circuits and means for securing the patch to a subject and a breathable substrate which allows for stretchability when attached to a skin of a user without nicking, curling or lifting from the skin surface ([0190] & [0203]).
Furthermore, even though Walter does not explicitly explain where the position of the at least one circuit is on the device, it would have been obvious to one of ordinary skill in the art to position the at least one circuit comprising a thin, flexible film connector on the silicone fabric substrate as taught by Toth (wireless communication 1130 along all the electrical circuitry for collecting signals from electrodes are disposed on the substrate layer 1109 as shown in Fig. 11a, [0351]; [0164], [0234: the wireless communication is in a form of an antenna which can be printed; note that any printed conductive material inherently provides a flexible thin film arrangement).
Toth does not explicitly disclose that the substrate is a silicone fabric. Rather is discloses that the substrate is a polymeric material coated with silicone and/or silicone micro/nano bead layer ([0198]-[0199]).
Woodroof teaches a textile (garment 10 in Fig. 1) comprising a fabric (fabric material 14) and a thin silicone (elastomer 12) disposed on the fabric (col. 3, ln. 19-21 & 36-44) to provide a fabric elastomer composite that is waterproof, breathable and stretchable/flexible (col. 1, ln. 9-15). Given that Toth discloses that the substrate comprises a polymeric material coated with a thin silicone, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to substitute the polymeric material of Toth with a fabric as taught by Woodroof so that the resulting material is a silicone fabric substrate, as doing so provides the same result of waterproof, breathable and stretchable/flexible substrate (col. 1, ln. 9-15).
The Examiner notes that the combination of the modified hypoallergenic silicone adhesive substrate and the silicone fabric substrate of Walter/Toth/Woodroof combination provides a conformal and stretchable substrate for conformal and stretchable contact on a facial area.
In regards to claim 8, Walter/Toth/Woodroof combination further discloses wherein the at least one circuit further comprises an antenna ([0082]: data can be transferred wirelessly from the monitoring patch to an analysis system; therefore, the wireless transfer of data inherently requires an antenna).
Claims 2, 5-7 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Walter, Toth and Woodroof as applied to claim 1 above, and further in view of Kellokoski et al. (hereinafter ‘Kellokoski’, WO 2017/060560).
In regards to claim 2, Walter/Toth/Woodroof combination discloses the invention substantially as claimed in claim 1 and discussed above. Walter/Toth/Woodroof combination further discloses that the wearable patch device is attachable to a forehead portion of the facial area and configured to measure EEG and EOG ([0035]: “The monitoring patch 100 may be attached (e.g., adhered, etc.) to selected areas of the subject's head. For example, the monitoring patch 100 may be attached to the subject's forehead and temple such that it is overlying the frontal and temporal lobes in order to monitor EEG and EOG activity and the temporalis muscle in order to monitor EMG activity, etc.”).
However, Walter/Toth/Woodroof combination does not disclose the device further comprises a second wearable biopatch attachable to the chin and configured to measure EMG, and the second wearable biopatch being electrically linked to the wearable biopatch device to provide synchronous measurements of the EEG sensing, EOG sensing, and EMG sensing.
Kellokoski teaches a wearable biopatch device (Fig. 1) comprising a forehead portion (see patch portion attached to a wearer’s forehead in Fig. 1) having a plurality of electrodes configured for electroencephalography (EEG) signals, electromyography (EMG) and electrooculography (EOG) (see Fig. 2 for the different types of electrodes, pg. 10, ln. 14-20) and a chin portion (see patch portion attached to a wearer’s chin in Fig. 1) comprising EMG electrodes to determine sleep stages and cortical arousal (pg. 6, ln. 14-20; pg. 7, ln. 16-26). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device of Walter/Toth/Woodroof combination and incorporate a second wearable biopatch attachable to the chin of a wearer comprising EMG electrodes such that the second wearable biopatch is electrically connected to the wearable biopatch device of Walter as doing so provides a combination of EEG, EMG and EOG signals to determine sleep stages and cortical arousal (pg. 6, ln. 14-20).
In regards to claims 5-6, in view of the combination in claim 1 above, Kellokoski further discloses that the plurality of electrodes are stretchable and formed in a meandering or serpentine structure (pg. 9, ln. 13-14, Fig. 4 illustrates that the electrodes 102 are spiral shaped). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the electrodes of Walter/Toth/Woodroof combination and provide a meandering or serpentine structure as modifying the shape of the electrodes involves routine skill in the art.
In regards to claim 7, in view of the combination in claim 1, Kellokoski further discloses providing a common ground electrode (ground electrode Gnd in Fig. 2) and a common reference electrode (reference electrode Ref in Fig. 2). Any of the EEG electrodes can be a first recording electrode (Af7, Fp1, Fp2, and Af8). In addition, any of the EOG electrodes can be a second recording electrode (E1 and E2). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to provide ground and common electrodes for EEG, EMG and EOG recording as doing so is well-known in the art to improve signal quality by reducing noise (Kellokoski, pg. 15, ln. 1-4).
In regards to claim 11, Walter/Toth/Woodroof combination discloses the invention substantially as claimed in claim 1 and discussed above.
However, Walter/Toth/Woodroof combination does not disclose a chest-mounted cardiorespiratory patch.
Kellokoski teaches a wearable biosensor device comprising a forehead assembly (see forehead patch in Fig. 1) and a chest-mounted cardiorespiratory patch (Fig. 1 shows a chest belt; pg. 9, ln. 1-5: “patient may be connected e.g. to electrocardiography sensors, a pulse oximeter, and/or respiratory effort belts detecting the movements of chest and abdomen…”). Kellokoski teaches that ECG data and respiratory data can be further used to determine sleep stages and sleep disorders (pg. 1, ln. 5-8). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device of Walter/Toth/Woodroof combination and further integrate a cardiorespiratory patch configured to measure ECG and respiratory signals as taught by Kellokoski to determine different sleep stages and diagnose sleep disorders (pg. 1, ln. 5-8).
Claims 3 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Walter, Toth and Woodroof as applied to claim 1 above, and further in view of Lee et al. (hereinafter ‘Lee’, U.S. PGPub. No. 2021/0045675).
In regards to claims 3 & 4, Walter/Toth/Woodroof combination discloses the invention substantially as claimed in claim 1 and discussed above.
Walter/Toth/Woodroof combination discloses the device is configured to monitor brain activity and eye movement to provide the EEG sensing and EOG sensing to an analysis system ([0048]-[0050]: electronic apparatus 206 is configured to monitor the state of vigilance of a wearer or sleep duration and sleep cycles).
However, Walter/Toth/Woodroof combination does not disclose wherein the analysis system configured with a trained machine learning or neural network to provide sleep stage classification and apnea event detection, wherein the trained machine learning or neural network is configured to provide output for monitoring, tracking, and/or diagnose obstructive sleep apnea.
Lee teaches an analysis system (data processing apparatus 100 in Fig. 1) configured to monitor sleep based upon EEG, EOG, EMG and other physiological signals ([0073]). Lee further explains that a sleep stage classification model (120 in Fig. 1) which includes AI model is configured to use the monitored brain activity, eye movements and facial muscle activity signals and to classify a sleep stage corresponding to the signal data and determine for example, sleep apnea, sleep disorder, sleep walking, etc. ([0004], [0013]-[0015], [0070], [0073], [0076]-[0077], [0205]: “it is possible to improve accuracy and reliability of polysomnography by generating a sleep stage determination model through a machine training based on an artificial neural network in which a CNN and an RNN are combined”). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Walter/Toth/Woodroof combination to configure the analysis system of Walter/Toth/Woodroof combination and incorporate a trained machine learning or neural network to provide sleep stage classification and further determine sleep disorder ([0009]-[0015]: determined sleep stage based upon EEG, EOG and EMG is used to determine a sleep disorder based upon an AI model and then using the determined sleep stage, for diagnosing a sleep disorder; a list of sleep disorder is listed in [0004] which includes sleep apnea).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Walter, Toth and Woodroof as applied to claim 1 above, and further in view of Buckman et al. (hereinafter ‘Buckman’, U.S. PGPub. No. 2005/0067816).
In regards to claim 9, Walter/Toth/Woodroof combination discloses the invention substantially as claimed in claim 1 and discussed above.
However, Walter/Toth/Woodroof combination does not disclose wherein the silicone fabric substrate comprises polytetrafluoroethylene (PTFE).
Buckman teaches that waterproof fabric can further be achieved by using polyurethane or PTFE woven to maximize strength and to form a barrier cloth that is impermeable to gas ([0083]). Therefore, the it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the fabric of Walter/Toth/Woodroof combination and weave PTFE to maximize the strength of the knitted fabric and provide a barrier fabric that is impermeable to gas ([0083]).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Walter, Toth and Woodroof as applied to claim 1 above, and further in view of Longinotti-Buitoni et al. (hereinafter ‘Longinotti-Buitoni’, U.S. PGPub. No. 2017/0319132).
In regards to claim 10, Walter/Toth/Woodroof combination discloses the invention substantially as claimed in claim 1 and discussed above.
However, Walter/Toth/Woodroof combination is silent as to the hypoallergenic silicone adhesive substrate that is between 50 micrometers and 300 micrometers.
Longinotti generally teaches that an adhesive coating is generally thin and that the thickness is between 10 and 200 micrometers ([0059]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the hypoallergenic silicone adhesive substrate of Walter/Toth/Woodroof combination and provide a thin layer of adhesive having a thickness generally between 10 and 200 micrometers as taught by Longinotti as doing so involves routine skill in the art to allow the patch to flex and conform to the skin while minimizing the overall bulkiness.
Claim 12 and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Walter, Toth and Woodroof as applied to claim 1 above, in view of Lee and further in view of Barnacka et al. (hereinafter ‘Barnacka’, U.S. PGPub. No. 2022/0218273).
In regards to claims 12 and 14-15, Walter/Toth/Woodroof combination discloses the wearable biopatch device as claimed in claim 1 and discussed above.
Walter/Toth/Woodroof combination further discloses the device comprising an analysis system ([0048]-[0050]: electronic apparatus 206 is configured to monitor the state of vigilance of a wearer or sleep duration and sleep cycles).
However, Walter/Toth/Woodroof combination does not disclose wherein the analysis system is configured with a trained machine learning or neural network to provide sleep stage classification and apnea event detection, wherein the trained machine learning or neural network is configured to provide a sleep score associated with a sleep stage classification and apnea event detection.
Lee teaches an analysis system (data processing apparatus 100 in Fig. 1) configured to monitor sleep based upon EEG, EOG, EMG and other physiological signals ([0073]). Lee further explains that a sleep stage classification model (120 in Fig. 1) which includes AI model is configured to use the monitored brain activity, eye movements and facial muscle activity signals and classify a sleep stage corresponding to the signal data and determine for example, sleep apnea, sleep disorder, sleep walking, etc. ([0004], [0013]-[0015], [0070], [0073], [0076]-[0077], [0205]: “it is possible to improve accuracy and reliability of polysomnography [sleep study] by generating a sleep stage determination model through a machine training based on an artificial neural network in which a CNN and an RNN are combined”). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Walter/Toth/Woodroof combination to configure the analysis system of Walter/Toth/Woodroof combination and incorporate a trained machine learning or neural network to provide sleep stage classification and further determine sleep disorder ([0009]-[0015]: determined sleep stage based upon EEG, EOG and EMG is used to determine a sleep disorder based upon an AI model and then using the determined sleep stage, for diagnosing a sleep disorder; a list of sleep disorder is listed in [0004] which includes sleep apnea).
However, Walter/Toth/Woodroof/Lee combination does not disclose wherein the analysis system is a remote analysis system separate from the wearable biopatch device and configured to receive signals from the wearable biopatch device and either (i) relay the received signal to a cloud analysis system having the trained machine learning or neural network or (ii) perform the analysis with a locally executing train machine learning or neural network, wherein the remote analysis system or the cloud analysis system.
Barnacka discloses a sleep monitoring analysis and management system (Fig. 1A) comprising a wearable sensing device (biosensor system 102) configured to be worn by an individual and cloud analysis system (a network cloud 108) in communication with the wearable sensing device or indirectly via a remote analysis system (a user device 107) configured for a short-range communication interface ([0082]). Barnacka specifically discloses that the remote analysis system (user device 107 receive 101R raw data from a controller board 105 of the biosensor system 102, [0082] and relays the received signals to the cloud analysis system (the biosignal 101C is transferred over link 6-2 to an application server 132 of the data analysis system 209, [0082]). In addition, the cloud analysis system comprises a trained machine learning or neural network (the data analysis system 109 of the network cloud 108 analyzes the biosignals 101 and can access machine learning models 1186, access sleep stage models 188, the snore models 182…; [00170]: the data analysis system 109 identifies the awake state, the sleep stage, and to identify and characterize sleep events; [0173]: The data analysis system 109 can also detect sleep disorder; [0183]: the snore module is configured to determine obstructive sleep apnea). Barnacka further discloses that the sleep system can analyze the detected biosignal locally ([0022]), through a cloud analysis system ([0021]) and wirelessly via a user device ([0020]: smartphone) where the cloud analysis system comprises cloud infrastructure ([0021]: the remote network can be public or private cloud network such as Amazon Web Servies (AWS), Microsoft Cloud services, IBM Cloud Services, Oracle Cloud Infrastructure, or other public or private cloud service), thus meeting claim 15. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Walter/Toth/Woodroof combination and incorporate various means to analyze signals from the wearable biopatch including a cloud analysis system and a remote analysis system as taught by Barnacka as doing so involves routine skill in the art and a predictable result of having various ways to analyze the incoming sensor data would ensue.
Claim 13 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Walter, Toth, Woodroof, Barnacka and further in view of Colman et al. (hereinafter ‘Colman’, U.S. PGPub. No. 2013/0096404).
In regards to claims 13 and 16, Walter/Toth/Woodroof/Lee/Barnacka combination discloses the invention substantially as claimed in claim 12 and 14, respectively. Barnacka further teaches that the sleep system can analyze the detected biosignal locally ([0022]), through a cloud analysis system ([0021]) and wirelessly via a user device ([0020]: smartphone).
Walter/Toth/Woodroof/Lee/Barnacka combination does not disclose that the remote analysis system or the cloud analysis system configured to provide a sleep score associated with a sleep stage classification and apnea event detection.
Coleman teaches a sleep monitoring system configured to use various physiological sensed information such as EEG data, chest movement and additional parameters ([0061]) to compute a sleep score ([0061]: the method further comprises monitoring one or more additional parameters selected from the group consisting of: heart rate, encephalogram (EEG), breath flow and chest movement, wherein the computing of the continuous integrated sleep score is further based on one or more of the additional parameters). The sleep score is calculated by linear or non-linear function based upon values of the parameters which correlate to sleep quality and apnea ([0015]) where a sleep score of 100 out of 100 indicates a normal range; however, if the sleep score decreases to 80, indicates a chronic pulmonary disease with relatively low oxygen level ([0118]-[0119]). Furthermore, the sleep score is presented on a display ([0086]). Given that Walter/Toth/Woodroof/Lee/Barnacka combination is concerned with sleep stage and diagnosing sleep disorder, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to provide a single score by weighing the parameters such as the sleep stage and a parameter related to apnea (e.g. breathing cessation) as taught by Coleman, as doing so provides a single indicator to easily determine an overall sleep quality and breathing ([0118]-[0120]).
Claims 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Kellokoski, Toth, Woodroof, and further in view of Lee.
In regards to independent claim 17, Kellokoski discloses a method of sleep monitoring (pg. 1, ln. 1-3: “method for determination of sleep stages”) comprising:
providing a wearable biopatch device (providing a facial assembly of Fig. 1 on a forehead and chin of a wearer, pg. 9, ln. 24-25 & pg. 13, ln. 14-21); wherein the wearable biopatch device comprises:
a substrate (pg. 14, ln. 4-6: “base layer is used… such as Mylar, Kapton, polyester, polyethene, polypropene or polyimide film…”);
an integrated sensor system (Fig. 2 shows all the electrodes arranged on the facial assembly) coupled to an inner surface of a substrate (the electrodes are arranged on a skin facing surface); and
at least one circuit configured for wireless data transmission (pg. 10, ln 24-28: the means 104 for transmitting the measurement data can be implemented by wired or wireless signal transmission techniques. The wireless means 104 comprises transmitter for sending the measurement data and a receiver for receiving the measurement data);
sensing, via the plurality of electrodes, EEG signals from at least three electrodes configured for EEG sensing (six EEG electrodes Fp1, Epf2, Af7, Af8, T9, T10 in Fig. 2) and EOG signals from two electrodes configured for EOG sensing (two EOG electrodes E1 and R2) over a period spanning at least one REM cycle (pg. 17, ln. 9-10: the examiner notes that a full polysomnography inherently includes REM cycle of the sleep stage);
processing and segmenting, at the local computing device, the sensed EEG signals and the sensed EOG signals (pg. 14, ln. 26-27: “determination of sleep stages…”; note that the determination step inherently requires a processing means which uses the physiological signals acquired from the EEG, EOG and EMG electrodes and segments or classifies the incoming signals into different sleep stages);
transmitting the sensed EEG signals and the sensed EOG signals to local computing device (pg. 10, ln 24-28: the means 104 for transmitting the measurement data can be implemented by wired or wireless signal transmission techniques. The wireless means 104 comprises transmitter for sending the measurement data and a receiver for receiving the measurement data to a measurement data unit).
However, Kellokoski Lee does not disclose that at least three electrodes comprising EOG electrodes. It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Lee and provide an additional EOG electrode, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8. In addition, providing an additional electrode provides redundancy in case an electrode loses contact or an electrode malfunction, etc. or as a reference electrode ([0059]).
However, Kellokoski does not disclose the wearable biopatch device comprising a hypoallergenic silicone adhesive substrate and a fabric substrate.
Toth teaches a medical patch (patch 1105 in Figs. 11a-11b) comprising an adhesive layer (a patient facing adhesive layer 1155, [0352]; [0193] & [0198]: the adhesive layer is a silicone adhesive). The Examiner notes that the silicone type adhesive is inherently a hypoallergenic material or results in less likely to cause allergic reaction compared to latex or rubber. In addition, Toth teaches providing a substrate above the adhesive layer (substrate 1109 in Fig. 11a; [0198]-[0199]: the substrate is coupled to the thin adhesive layer) to provide stretchability when attached to a skin of a user without nicking, curling or lifting from the skin surface ([0190]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to substitute the adhesive layer of Kellokoski with a silicone adhesive as taught by Toth, which inherently results in less allergic reaction compared to other allergic prone materials, as the equivalent of various materials such as acrylic adhesive, silicone adhesive, hot melt pressure sensitive adhesive, hydrogel adhesive for attaching a medical patch on to a skin involves routine skill in the art ([0193]). Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to provide a substrate above the modified hypoallergenic silicone adhesive substrate as doing so provides 1) support to one or more interconnects, sensors and circuits and means for securing the patch to a subject and a breathable substrate which allows for stretchability when attached to a skin of a user without nicking, curling or lifting from the skin surface ([0190] & [0203]).
Furthermore, even though Kellokoski/Toth combination does not explicitly explain where the position of the at least one circuit (e.g. wireless transmission means) is on the device, it would have been obvious to one of ordinary skill in the art to position the at least one circuit comprising a thin, flexible film connector on the silicone fabric substrate as taught by Toth (wireless communication 1130 along all the electrical circuitry for collecting signals from electrodes are disposed on the substrate layer 1109 as shown in Fig. 11a, [0351]; [0164], [0234: the wireless communication is in a form of an antenna which can be printed; note that any printed conductive material inherently provides a flexible thin film arrangement).
However, Kellokoski/Toth combination does not disclose that the fabric substrate is a silicone fabric substrate.
Woodroof teaches a textile (garment 10 in Fig. 1) comprising a fabric (fabric material 14) and a thin silicone (elastomer 12) disposed on the fabric (col. 3, ln. 19-21 & 36-44) to provide a fabric elastomer composite that is waterproof, breathable and stretchable/flexible (col. 1, ln. 9-15). Given that Kellokoski/Toth combination discloses that the substrate comprises a polymeric material, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to substitute the polymeric material of Kellokoski/Toth combination with a fabric as taught by Woodroof so that the resulting material is a silicone fabric substrate, and as doing so provides the same result of waterproof, breathable and stretchable/flexible substrate (col. 1, ln. 9-15). The Examiner notes that the combination of the modified hypoallergenic silicone adhesive substrate and the silicone fabric substrate of Kellokoski/Toth/Woodroof combination provides a conformal and stretchable substrate for conformal and stretchable contact on a facial area.
However, Kellokoski/Toth/Woodroof combination does not disclose analyzing, via the local computing device or a remote analysis system that received the data from the local computing device, the segmented EOG signals and the segment EEG signals via a trained machine learning operation; and provide a sleep score associated with a sleep disorder to a graphical user interface based on the analyzed brain activity data.
Lee teaches a sleep stage analysis system (data processing apparatus 100 in Fig. 1) configured to process and segment EEG and EOG signals via a trained machine learning operation ([0074]: The signal data detected through the polysomnography may be interpreted as biometric data that is measured from a subject through at least one detection device among an electroencephalogram (EEG) sensor, an electrooculography (EOG) sensor, an electromyogram (EMG) sensor; [0078]: the sleep stage classification model processor 120 may classify the sleep stage by applying an AASM sleep stage scoring rule or an R&K sleep stage scoring rule to the processed signal data). Lee further teaches providing a sleep score associated with a sleep disorder to a graphical user interface based on the analyzed brain activity data ([0091]: the sleep stage classification model processor 120 according to example embodiments may generate a sleep state determination model through machine training based on an artificial neural network in which a convolution neural network (CNN) and a recurrent neural network (RNN) are combined, thereby improving accuracy and reliability of the scoring results of polysomnography; [0180] referring to the output result 500 of FIG. 5, a vertical axis represents each sleep stage and a horizontal axis represents a line length in a time domain; the examiner notes that out of normal range of the scoring result is potentially associated with a sleep disorder). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the local computing device of Kellokoski/Toth/Woodroof combination so that it operates sleep stage determination using a trained machine learning 2and provides a sleep score to a graphical user interface as taught by Lee, for diagnostic purposes of sleep disorder involves routine skill in the art ([0004]).
In regards to claim 18, in view of the combination in claim 17, Lee further teaches classifying, based on the sleep score, a sleep stage; and detecting, based on the sleep score, a sleep apnea event ([0091]: The sleep stage classification model processor 120 according to example embodiments may generate a sleep state determination model through machine training based on an artificial neural network in which a convolution neural network (CNN) and a recurrent neural network (RNN) are combined, thereby improving accuracy and reliability of the scoring results of polysomnography; the examiner notes that a real-time determination of the sleep score inherently depends on the previous sleep stage and sleep apnea event).
In regards to claim 19, in view of the combination of claim 17, Kellokoski further discloses wherein the at least three electrodes associated with the EEG sensing are placed on the forehead to acquire the EEG signals (EEG electrodes Fp1, Fp2, Af7, Af8 in Fig. 2), and wherein the at least three electrodes associated with the EOG sensing are placed at the temple to acquire the EOG signals (E1 and E2 and an additional E1 and E2 in case of malfunction as shown in Fig. 2).
In regards to claim 20, in view of the combination in claim 17, Kellokoski/Toth/Woodroof/Lee combination further discloses wherein the wearable biopatch device is self-applying to be installed by the subject (Toth, a medical patch 1105 in Figs. 11a-11bcomprising a silicone adhesive layer which is configured for self-applying, [0352]; [0193] & [0198]) and wherein the EEG signals and EOG signals are monitored by a user at a remote location (Kellokoski, pg. 10, ln 24-28: The wireless means 104 comprises transmitter for sending the measurement data and a receiver for receiving the measurement data to a measurement data unit).
Conclusion
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/EUN HWA KIM/Primary Examiner, Art Unit 3794 8/13/2026
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