DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. 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 (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.
Continued Examination Under 37 CFR 1.114
2. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 15 June 2026 has been entered.
Status of Claims
3. Claims 13-14, 32-33, 40-49, and 65-70 are pending, of which claim 13, 32, 42, 47-49 have been amended; claim 70 has been added; claims 1-12, 15-31, 34-39, and 51-64 have been canceled; and claims 13-14, 32-33, 40-50, and 65-69.
Response to Arguments
4. Applicant’s arguments dated 15 June 2026, referred to herein as “the Arguments”, have been fully considered, but they are not persuasive in view of the new grounds of rejection necessitated by Applicant’s amendments to the claims.
The Examiner has addressed the amended limitations within the 103 rejection section below.
The Examiner previously rejected claims 13-14, 32-33, 40-49, and 65-69 under 35 U.S.C. 101. However, Applicant argues that 101 rejections should be withdrawn in response to the amendment which integrates the claims into a practical application and the claims recite a non-conventional arrangement of additional elements. The Examiner respectfully disagrees, as the amendments introduces elements (e.g., energy storage module comprising rechargeable circuit and rechargeable batteries) that are known conventional element and do not provide significantly more to the claim. Furthermore, the amendment recites that “the agent of interest is being evaluated for regeneration of tissue at the injury site” which does not add significantly more to the claim. In this case, its routine and conventional to utilize sensors for continuously monitoring the status of an injury (e.g., wounded tissue) before and after the administration of an agent to determine if the injury is healing. Thus, the Examiner respectfully maintains the 101 rejections, as the claims are still drawn to an abstract idea (e.g., monitoring a subject with sensors before and after the administration of agent) and mathematical algorithms (e.g., comparing sensed data) without significantly more.
Applicant argues that Brownhill, Brockway, Bhavaraju, Cheng, Gao, and Davis do not explicitly suggests the claim amendments reciting a system that includes a skin wearable printed sensor that acquires signals of an animal subject to provide real-time, continuous monitoring of electrophysiological parameters of the animal subject that was administered an agent of interest and subjected to an injury, wherein the agent of interest is being evaluated for regeneration of tissue at the injury site, and where the animal subject is an animal model that exhibits impaired regeneration of tissue at the injury site. The Examiner has introduced additional references (e.g., Jacobs) in the updated text below to address the limitation that recites wherein the agent of interest is being evaluated for regeneration of tissue at the injury site. However, the Examiner respectfully submits that Brownhill still provides teachings for a skin-wearable printed sensor that acquires signals from an animal subject (the sensors 406 may be printed onto the fabric of the garment or compression apparatus 402 which is applied to animal’s body [0036-0037, 0249, 0276, FIG. 4A]) and the administration of an agent of interest ([0212]). Specifically, Brownhill teaches wherein the animal subject is an animal model that exhibits impaired regeneration of tissue at the injury site (the processor 404 of the system 400 may determine that the wound is not healing well (e.g., impaired regeneration) based on the EMG data obtained from the sensors 406 [0210, 0276, 0297, 0302]). Meanwhile, Brockway was relied upon for specifically teaching a stretchable graphene sensor that is applied to an animal ([0001, 0012, 0037, 0052]). Furthermore, Bhavaraju was relied upon for specifically teaching the continuous collection of the sensor data before and after the administration of the agent, rather than teaching the animal subject (the monitoring sensor platform 330 comprises a comparator that is configured to compare the physiological signals which were obtain before and after the administration of the medication or agent [0026, 0040, 0050-0051, 0059]). The Examiner further submits that the other references (e.g., Cheng, Gao, and Davis) were introduced in the dependent claims to address structural features of the device (e.g., electrodes), rather than teaching the animal subject (see the rejection below). In response to applicant's argument that each of the additional references do not teach an animal subject, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
Claim Objections
5. Claims 65 and 70 are objected to because of the following informalities.
Claims 65 and 70 recites the limitation wherein the animal model is a craniofacial VML model. The Examiner respectfully submits that term acronym “VML” needs to be defined.
Appropriate correction is required.
Claim Rejections - 35 USC § 101
6. 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.
7. Claims 13-14, 32-33, 40-49, and 65-70 are rejected under 35 U.S.C. 101 because the claimed invention is directed to abstract idea and mathematical algorithms without significantly more. Specifically, claims 13-14, 32-33, 40-49, and 65-70 recite the comparison of physiological signals or parameters that are collected by a skin-wearable printed sensor. This judicial exception is not integrated into a practical application because the claims are directed to using sensors to monitor a subject (abstract idea) and comparing data (mathematical algorithms). Furthermore, the claimed sensors are considered to be routine and conventional elements that collect data, such as an electrocardiogram sensor, electroencephalogram sensor, infrared sensor, impedance sensor, or an electrical sensor. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the data collected from the sensors is not utilized to provide a substantial step (e.g., feedback loops, therapy adjustments, diagnosis, etc.).
Claim Rejections - 35 USC § 103
8. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
9. Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Brownhill et al. (US 2020/0297244 A1) in view of Brockway et al. (US 2016/0345850 A1), Jayalth et al. (US 2014/0135593 A1), Bhavaraju et al. (US 2011/0224912 A1), and Jacobs (US 2008/0281244 A1).
Regarding claim 13, Brownhill teaches a system comprising (the embodiments of the invention comprise an apparatus having one or more sensors that are configured to monitor an injury of animal’s tissue or muscle [0035-0037, 0051, 0297]. For example, the compression apparatus 402 comprises one or more sensors 406 (e.g., electromyography sensors) that are configured to detect muscle activity at the injured or wounded location of the animal’s body [0035-0036, 0258, 0276, 0297]), comprising:
a skin-wearable printed sensor (the sensors 406 may be printed onto the fabric of the garment or compression apparatus 402 which is applied to animal’s body [0036-0037, 0249, 0276, FIG. 4A]);
electronics coupled to the skin-wearable printed sensor (the Examiner respectfully submits that it is inherent that that sensors 406 would include electronics or circuitry [0035-0037, 0249, 0276])
an animal subject ([0035-0036]) comprising the skin-wearable printed sensor over the animal subject's skin (the compression apparatus 402 comprises one or more sensors 406 (e.g., electromyography sensors) that are configured to detect muscle activity at the injured or wounded location of the animal’s body [0035-0036, 0258, 0276, 0297]. Specifically, the compression apparatus 402 may be positioned on the animal’s head, neck, chest, thigh, or calf [0036, 00249-0250, 0276]. Furthermore, the sensors 406 may be printed onto the fabric of the garment or compression apparatus 402 which is applied to animal’s body [0036-0037, 0249, 0276, FIG. 4A]), wherein the animal subject was subjected to an injury ([0035-0036]), wherein the sensors are configured to monitor the regeneration of a tissue at the injury site (the sensors 406 may monitor the healing of the wound (e.g., tissue regeneration) [0210, 0276, 0297, 0302]. For example, the processor 404 of the system 400 may determine if the wound is not healing well (e.g., impaired regeneration) based on the EMG data obtained from the sensors 406 [0210, 0276, 0297, 0302]);
wherein the animal subject is an animal model that exhibits impaired regeneration of tissue at the injury site (the compression apparatus 402 comprises one or more sensors 406 (e.g., electromyography sensors) that are configured to detect muscle activity at the injured or wounded location of the animal’s body [0035-0036, 0258, 0276, 0297]. The Examiner respectfully submits that the sensors 406 may monitor the healing of the wound [0210, 0276, 0297]. For example, the processor 404 of the system 400 may determine if the wound is healing well or if the wound is not healing well (e.g., impaired regeneration) based on the EMG data obtained from the sensors 406 [0210, 0276, 0297, 0302]);
an energy storage module configured to provide energy for the skin-wearable sensor system and sensors, wherein the energy storage module comprises a rechargeable circuit and rechargeable batteries (the energy storage module (e.g., control module) contains a power source, such as rechargeable batteries coupled with electronic circuits to drive the sensors [0234, 0240]), wherein the batteries are sized for a first duration (the Examiner respectfully submits that the rechargeable batteries may be a Lithium ion battery which is known to last for a duration before it needs to be recharged [0234, 0240]);
wherein the skin-wearable printed sensor comprises one or more sensors configured as a sensor selected from the group consisting of an electromyogram (EMG) sensor or an electrical sensor (the compression apparatus 402 comprises one or more sensors 406 (e.g., electromyography sensors) that are configured to measure the muscle activity at the injured or wounded location of the animal’s body [0035-0036, 0258, 0276, 0297]. Specifically, the processor 404 may monitor the electromyography (EMG) data from the sensors 406 to determine if the injured or wounded location is healing [0258, 0276, 0297]. Furthermore, the one or more sensors 406 may also include an electrical or complex conductivity sensor ([0251]), wherein the wearable printed sensor continuously acquires signals of the animal subject’s electrophysiological parameters in real-time over multiples of the first durations (the compression apparatus 402 comprises one or more sensors 406 (e.g., electromyography sensors) that are configured to continuously measure the muscle activity and movement at the injured or wounded location of the animal’s body [0035-0036, 0258, 0276, 0297]. Specifically, the processor 404 may continuously monitor the electromyography (EMG) data from the sensors 406 to determine if the injured or wounded location is healing [0258, 0276, 0297, 0302]. For example, the processor 404 of the system 400 may continuously monitor the data EMG from the sensors 406 to determine the wound healing rate or the percent healed (e.g., 10, 20, 50, 70, or 100% healed) during the treatment [0258, 0276, 0297, 0302]. As stated previously above, the energy storage module (e.g., control module) contains a power source, such as rechargeable batteries (e.g., lithium-ion batteries) coupled with electronic circuits to drive the sensors [0234, 0240]. The Examiner respectfully submits that it is inherent that the rechargeable batteries will have to be recharged to operate the sensors over multiple durations (e.g., battery life durations) [0234, 0240]);
a computer having instructions stored thereon ([0244, 0316]); and
a processor ([abstract, 0244, 0316]).
Brownhill does not explicitly teach the sensors to be composed of a stretchable graphene material; and
wherein the rechargeable circuit and rechargeable batteries are wireless recharged via inductive charging operations.
Although Brownhill teaches the administration of an agent of interest and the sensing of physiological parameters ([0212]), Brownhill does not explicitly teach wherein the skin-printed wearable sensor continuously acquires signals of the animal subject’s electrophysiological parameter before and after administration of an agent of interest; and
wherein execution of the instructions by the processor of the computer causes the processor to:
compare the continuously acquired signals of the animal subject before and after administration of an agent of interest over the multiple first durations;
analyze a result from the comparison step to assess a physiological parameter of the subject over the multiple first durations; and
wherein the physiological parameter provides an indication that the agent of interest is a therapeutic agent.
Although Brownhill teaches the sensors to monitor the regeneration of tissue at the injury site ([0210, 0276, 0297, 0302]), Brownhill does not explicitly teach wherein the agent of interest is being evaluated for regeneration of tissue at the injury site.
The prior art by Brockway is analogous to Brownhill, as they both teach wearable physiological sensors or electrodes that are configured to monitor physiological signals from an animal ([0001]).
Brockway teaches the sensors to be composed of a stretchable graphene material (the sensing electrodes may be composed of a stretchable graphene material that is highly conductive [0001, 0012, 0037, 0052]).
The prior art by Jayalth is analogous to Brownhill, as they both teach wearable physiological sensors that are configured monitor physiological signals from an animal ([abstract, 0028]).
Jayalth teaches wherein the rechargeable circuit and rechargeable batteries are wireless recharged via inductive charging operations ([0054]).
The prior art by Bhavaraju is analogous to Brownhill, as they both teach the administration of an agent and monitoring physiological parameters ([abstract, 0040, 0042, 0051]).
Bhavaraju wherein the skin-printed wearable sensor continuously acquires signals of the animal subject’s electrophysiological parameter before and after administration of an agent of interest (the monitoring sensor platform 330 (e.g., ECG, EMG, or EEG sensors) is configured to obtain physiological signals from the patient’s body 300 [0025-0026, 0029, 0040, 0046]. Furthermore, the monitoring sensor platform 330 comprises a comparator that is configured to compare the physiological signals which were obtain before and after the administration of the medication or agent [0026, 0040, 0050-0051, 0059]); and
wherein execution of the instructions by the processor of the computer causes the processor to:
compare the continuously acquired signals of the animal subject before and after administration of an agent of interest over the multiple first durations (Bhavaraju teaches the monitoring sensor platform 330 comprising a comparator that is configured to compare the physiological signals which were obtain before and after the administration of the medication or agent [0026, 0050-0051, 0059]. As stated previously, Brownhill taught rechargeable batteries that are recharged to operate the sensors over multiple durations (e.g., battery life durations) [0234, 0240]);
analyze a result from the comparison step to assess a physiological parameter of the subject over the multiple first durations (Bhavaraju teaches the comparator being configured to compare the sensed physiological signals which were obtain before and after the administration of the medication or agent [0026, 0051, 0059-0060]. Specifically, the comparator can determine if the medication or agent has produced a desired or non-desired physiological outcome [0026, 0029, 0051, 0059]. As stated previously, Brownhill taught rechargeable batteries that are recharged to operate the sensors over multiple durations (e.g., battery life durations) [0234, 0240]); and
wherein the physiological parameter provides an indication that the agent of interest is a therapeutic agent (the comparator is configured to compare the physiological signals which were obtain before and after the administration of the medication or agent [0026, 0051, 0059]. Specifically, the comparator can determine if the medication or agent has produced a desired or non-desired physiological outcome [0026, 0029, 0051, 0059]. The Examiner respectfully submits that the medication or agent is determined to have a therapeutic effect if the desired physiological outcome is achieved [0059]).
The prior art by Jacobs is analogous to Brownhill, as they both teach a wearable device that is configured to monitor the healing of a wound ([0018, 0039, 0045]).
Jacobs teaches wherein the agent of interest is being evaluated for regeneration of tissue at the injury site (the wearable bandage 22 comprises treatment portion 32 having sensors that are configured to monitor the healing of a wound during the administration of a drug [0018, 0039, 0045]. Specifically, the display 104 monitor the administration of the drug source and the healing locations of the tissue [0045]).
Similar to Brownhill, Jacobs also teaches an energy storage module configured to provide energy for the skin-wearable sensor system and sensors, wherein the energy storage module comprises a rechargeable circuit and rechargeable batteries (the energy storage module or power supply 106 having a rechargeable battery that is coupled with a flexible electronic controller 34 [0046] Specifically, the flexible electronic controller 34 controls the wearable bandage 22 consisting of sensors [0018, 0039, 0045-0046]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify the Brownhill’s wearable sensors to be composed of a stretchable graphene material, as taught by Brockway. The stretchable graphene material is beneficial, as the graphene material will enhance the flexibility of the sensor (e.g., electrode) such that it can conform easily to the contours of the body surface (see paragraphs [0001, 0012, 0037, 0045, 0052] by Brockway). Specifically, the stretchable graphene material will enhance the sensor’s (e.g., electrode) conductive properties (see paragraphs [0012, 0037, 0045, 0052] by Brockway). Additionally, it would have been obvious to modify Brownhill’s rechargeable circuit and rechargeable batteries to be wirelessly recharged via inductive charging operations, as taught by Jayalth. This modification is beneficial, as wireless charging will allow the device to be charged without having to rely on cables (see paragraph [0054] by Jayalth). Furthermore, it would have been obvious to a person having ordinary skill in the art to modify Brownhill’s processor to compare the electrophysiological parameters before and after the administration of an agent of interest to determine if the agent of interest is a therapeutic agent, as taught by Bhavaraju. The advantage of such modification will help determine physiological effects or events resulting from administering the agent or medication (see paragraphs [0026, 0040, 0050-0051, 0059] by Bhavaraju). Lastly, it would have been obvious to a person having ordinary skill in the art to modify Brownhill’s agent of interest to be evaluated for regeneration of tissue at the injury site, as further taught Jacobs. The advantage of such modification will help determine if the wound is healing in response to the administration of the agent or drug (see paragraphs [0018, 0039, 0045] by Jacobs).
10. Claims 32-33, 48-49, and 67 are rejected under 35 U.S.C. 103 as being unpatentable over Bhavaraju et al. in view of Brownhill et al.
Regarding claim 32, Bhavaraju teaches a method of identifying therapeutic agent ([abstract]), the method comprising:
contacting a skin-wearable sensor with a subject's skin (the monitoring sensor platform 330 may be adhered or coupled to the patient’s body 300 [0023, 0025, 0046]);
acquiring signals from the skin-wearable sensor on the subject's skin (the monitoring sensor platform 330 is configured to obtain physiological signals (e.g., heart rate, blood pressure, etc.) from the patient’s body 300 [0025-0026, 0029, 0046]);
administering an agent of interest to the subject (a medication or agent is administered to the patient [0051, 0059]);
acquiring signals from the skin-wearable sensor on the subject's skin following administration of the agent of interest (the monitoring sensor platform 330 is configured to obtain physiological signals (e.g., heart rate, blood pressure, etc.) after the administration of the medication or agent [0026, 0029, 0046, 0059]);
executing instructions stored by a processor of a computer (figure 1 illustrates a cell phone or handheld computing device (e.g., the data collection device 120) which includes one or more comparators to compare the sensed physiological signals that were obtained before and after the administration of the medication or agent [0020, 0049-0051, 0059, FIG. 1]. The Examiner respectfully submits that it is inherent that the cell phone or handheld computing device (e.g., the data collection device 120) would have a processor which provides instructions for the comparator to compare the sensed physiological signals that were obtained before and after the administration of the medication or agent [0020, 0049-0051, 0059, FIG. 1]) to cause the processor to:
compare the signals of the subject before and after administration of the agent of interest (the comparator is configured to compare the physiological signals which were obtain before and after the administration of the medication or agent [0026, 0051, 0059]); and
analyze a result from the comparison step to assess a physiological parameter of the subject (the comparator is configured to compare the physiological signals which were obtain before and after the administration of the medication or agent [0026, 0051, 0059-0060]. Specifically, the comparator can determine if the medication or agent has produced a desired or non-desired physiological outcome (e.g., heart rate, blood pressure, etc.) [0026, 0029, 0051, 0059]);
wherein the physiological parameter provides an indication that the agent of interest is a therapeutic agent (the comparator is configured to compare the physiological signals which were obtain before and after the administration of the medication or agent [0026, 0051, 0059]. Specifically, the comparator can determine if the medication or agent has produced a desired or non-desired physiological outcome (e.g., heart rate, blood pressure, etc.) [0026, 0029, 0051, 0059]. The Examiner respectfully submits that the medication or agent is determined to have a therapeutic effect if the desired physiological outcome is achieved [0059]).
Bhavaraju does not explicitly teach the skin-wearable sensor to be a skin-wearable printed sensor;
and wherein the skin-wearable printed sensor is applied to an animal subject’s skin; and
wherein the animal subject is an animal model that exhibits impaired regeneration of tissue at an injury site.
The prior art by Brownhill is analogous to Bhavaraju, as they both teach the administration of agents and the sensing of physiological parameters ([0035-0037, 0212])
Brownhill teaches the skin-wearable sensor to be a skin-wearable printed sensor (the sensors 406 may be printed onto the fabric of the garment or compression apparatus 402 which is applied to animal’s body [0036-0037, 0249, 0276, FIG. 4A]);
wherein the skin-wearable printed sensor is applied to an animal subject’s skin (the sensors 406 may be printed onto the fabric of the garment or compression apparatus 402 which is applied to animal’s body [0036-0037, 0249, 0276, FIG. 4A]); and
wherein the animal subject is an animal model that exhibits impaired regeneration of tissue at an injury site (the compression apparatus 402 comprises one or more sensors 406 (e.g., electromyography sensors) that are configured to detect muscle activity at the injured or wounded location of the animal’s body [0035-0036, 0258, 0276, 0297]. The Examiner respectfully submits that the sensors 406 may monitor the healing of the wound [0210, 0276, 0297]. For example, the processor 404 of the system 400 may determine if the wound is healing well or if the wound is not healing well (e.g., impaired regeneration) based on the EMG data obtained from the sensors 406 [0210, 0276, 0297, 0302]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify Bhavaraju’s skin-wearable sensor to be a skin-wearable printed sensor that is applied to an animal subject that exhibits impaired regeneration of tissue at an injury site, as further taught by Brownhill. The advantage of such modification will provide a sensor skin-wearable printed sensor formed on garment that conforms to the animal subject to determine if the animal’s wound is healing or not healing (see paragraphs [0035-0036, 0258, 0276, 0297, 0302] by Brownhill).
Regarding claim 33, Bhavaraju in view of Brownhill suggests the method of claim 32. Brownhill teaches wherein the therapeutic agent improves an injury on the subject (the sensor monitors the healing of a wound during the administration of antimicrobials or other therapeutic agents [0210, 0212-0213, 0223]. Specifically, the sensors may monitor temperature, tissue color, pH, and oxygen saturation or SpO2 to determine if the wound is healing [0210, 0212-0213, 0223]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify the therapeutic agent suggested by Bhavaraju in view of Brownhill to improve an injury, as further taught by Brownhill. The advantage of such modification will allow the sensor to monitor the characteristics of the wound as it heals (see paragraphs [0210, 0212-0213, 0223] by Brownhill).
Regarding claim 48, Bhavaraju teaches wherein the sensor is an electrical sensor ([0040]).
Regarding claim 49, Bhavaraju teaches wherein the electrical sensor is selected from an electrocardiogram (ECG) sensor, an electroencephalogram (EEG) sensor, or an electromyogram (EMG) sensor ([0040]).
Regarding claim 67, Bhavaraju in view of Brownhill suggests the method of claim 32. Brownhill teaches wherein the skin-wearable printed sensor comprises a skin-wearable printed EMG sensor (the sensors 406 may be printed onto the fabric of the garment or compression apparatus 402 which is applied to animal’s body [0036-0037, 0249, 0276, FIG. 4A]. Specifically, the sensors 406 (e.g., electromyography sensors) that are configured to detect muscle activity at the injured or wounded location of the animal’s body [0035-0036, 0258, 0276, 0297]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify the skin-wearable printed sensor suggested by Bhavaraju in view of Brownhill to comprise a skin-wearable printed EMG sensor, as further taught by Brownhill. This modification is beneficial, as the processor may continuously monitor the electromyography (EMG) data from the sensors to determine if the injured or wounded location is healing ([0258, 0276, 0297, 0302] by Brownhill).
11. Claim 40 is rejected under 35 U.S.C. 103 as being unpatentable over Brownhill et al. in view of Brockway et al., Jayalth et al., Bhavaraju et al., Jacobs, and further in view of Cheng et al. (US 2017/0367654 A1).
Regarding claim 40, Brownhill in view of Brockway, Jayalth, Bhavaraju, and Jacobs suggests the system of claim 13. Brownhill teaches wherein the skin-wearable printed sensor comprises at least two electrodes (as stated previously in claim 13, the one or more sensors 406 may be printed onto the fabric of the garment or compression apparatus 402 which is applied to animal’s body [0037, 0249, 0276, FIG. 4A]. Specifically, the one or more sensors 406 may include conductivity sensors and/or EMG sensors [0251]. Furthermore, the conductivity sensors may include electrodes [0230, 0251]).
Meanwhile, Brockway teaches wherein skin-wearable printed sensor comprises a conductive flexible film (the electrode sensing surface is constructed of a thin flexible sheet or film 200 with a conductive surface [0045]).
Brownhill, Brockway, Jayalth, Bhavaraju, and Jacobs do not explicitly teach wherein the skin-wearable printed sensor comprises:
an elastomeric substrate.
The prior art by Cheng is analogous to Brownhill, as they both teach sensing electrodes that are coupled to a patient’s body ([0049, 0075]).
Cheng teaches wherein the skin-wearable printed sensor comprises:
an elastomeric substrate (the sensor patch 200 may comprise a plurality of sensing electrodes 204 that are printed on an elastic substrate 202 [0044, 0049, 0059, 0075]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify the skin-wearable printed sensor suggested by Brownhill in view of Brockway, Jayalth, Bhavaraju, and Jacobs to comprise an elastomeric substrate, as taught by Cheng. This modification is beneficial, as an elastomeric substrate can conform to various contours and/or swelling (e.g., bumps) of the skin surface (see paragraphs [0044, 0059, 0111]).
12. Claim 41-42 are rejected under 35 U.S.C. 103 as being unpatentable over Brownhill et al. in view of Brockway et al., Jayalth et al., Bhavaraju et al., Jacobs, Cheng et al., and further in view of Gao et al. (US 2020/0359942 A1).
Regarding claim 41, Brownhill in view of Brockway, Jayalth, Bhavaraju, Jacobs, and Cheng suggests the system of claim 40. Specifically, Brockway teaches wherein the electrodes comprise a graphene layer ([0011-0012, 0052]). Meanwhile, Cheng teaches a polyimide (PI) layer (the elastomeric substrate 202 may include a polyimide layer [0044, 0061]).
Brownhill, Brockway, Jayalth, Bhavaraju, Jacobs, and Cheng do not explicitly teach wherein the graphene layer of the electrodes is in contact with the polyimide layer.
The prior art by Gao is analogous to Brownhill, as they both teach sensing electrodes that are configured to monitor a biological signal from a patient ([abstract, 0052, 0066]).
Gao teaches wherein the graphene layer of electrodes is in contact with polyimide layer (the multimodal sensing layer 120 includes a polyimide film or substrate [0006, 0055]. Meanwhile, the graphene electrode 130 is laser scribed or engraved onto the polyimide film of the multimodal sensing layer 120 [0006, 0055, 0086]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify the graphene layer and the polyimide layer suggested by Brownhill, Brockway, Jayalth, Bhavaraju, Jacobs, and Cheng to contact each other, as taught by Gao. This modification is beneficial, as it may enhance the sensor’s detection of vital signals from the patient (see paragraphs [0006, 0052, 0055, 0086] by Gao).
Regarding claim 42, Cheng teaches wherein a polyimide layer is in contact with the elastomeric substrate (the elastomeric substrate 202 may include a polyimide layer [0044, 0061]).
13. Claims 43-46 are rejected under 35 U.S.C. 103 as being unpatentable over Brownhill et al. in view of Brockway et al., Jayalth et al., Bhavaraju et al., Jacobs, Cheng et al., and further in view of Davis et al. (US 2013/0110415 A1).
Regarding claim 43, Brownhill in view of Brockway, Jayalth, Bhavaraju, Jacobs, and Cheng suggests the system of claim 40. Brownhill, Brockway, Jayalth, Bhavaraju, Jacobs, and Cheng do not explicitly teach wherein the conductive flexible film connects the device with electronics.
The prior art by Davis is analogous to Brownhill, as they both teach wearable sensing devices ([0069-0071]).
Davis teaches wherein the conductive flexible film connects the device with electronics (the flexible strip 315 (e.g., conductive film) comprises electronic components that are connected with the wearable sensing components (e.g., sensor 210 or 310) [0069-0071]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify the conductive flexible film suggested by Brownhill in view of Brockway, Jayalth, Bhavaraju, Jacobs, and Cheng to connect the device with electronics, as taught by Davis. This modification is beneficial, as the conductive flexible film (e.g., flexible strip 315) has an encapsulation layer to protect the electronic components on the film which allows for maintaining a reliable connection to the wearable sensors (see paragraphs [0069-0071] by Davis).
Regarding claim 44, Davis teaches wherein the electronics comprise thin-film components (the electrical components are integrated on the flexible strip 315 (e.g., conductive film) [0070-0071]).
Regarding claim 45, Brownhill in view of Brockway, Jayalth, Bhavaraju, Jacobs, Cheng, and Davis suggest the system of claim 43. Davis teaches an alternate embodiment, wherein the electronics comprise wireless components (the electronics of the flexible strip 715 (e.g., conductive film) may be in wireless communication with a display 730 and/or the body sensors 750 [0095]).
The Examiner respectfully submits that each of the embodiments are drawn to conductive flexible films comprising electronics (the electronics of the flexible strip 315 and the electronics of the flexible strip 715 [0070-0071, 0095]). Thus, it would have been obvious to a person having ordinary skill in the art to combine each of the embodiments to arrive at an overall device similar to the one claimed. Specifically, the combination of the embodiments will result in the electronics having wireless components (the electronics of the flexible strip 715 (e.g., conductive film) may be in wireless communication with a display 730 and/or the body sensors 750 [0095]). The advantage of such modification will provide the conductive flexible film with electronics that can wirelessly communicate with a display and/or body sensors (see paragraph [0095] by Davis).
Regarding claim 46, Davis teaches wherein the thin film components comprises antenna or Bluetooth (the electronics of the flexible strip 715 (e.g., conductive film) may be in wireless communication with a display 730 and/or the body sensors 750 [0095]. The Examiner respectfully submits that that the wireless communication would inherently require the use of antennas or Bluetooth technology [0095]).
14. Claims 47 is rejected under 35 U.S.C. 103 as being unpatentable over Bhavaraju et al. in view of Brownhill et al., further in view of Brockway.
Regarding claim 47, Bhavaraju in view of Brownhill suggests the method of claim 32. Bhavaraju and Brownhill do not explicitly teach wherein the skin-wearable printed sensor comprises one or more stretchable graphene sensors.
The prior art by Brockway is analogous to Bhavaraju, as they both teach physiological sensors or electrodes ([0001]).
Brockway teaches wherein the skin-wearable printed sensor comprises one or more stretchable graphene sensors (the sensing electrodes may be composed of a stretchable graphene material that is highly conductive [0001, 0012, 0037, 0052]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify the skin-wearable printed sensor suggested by Bhavaraju in view of Brownhill to be composed of a stretchable graphene material, as taught by Brockway. The stretchable graphene material is beneficial, as the graphene material will enhance the flexibility of the sensor (e.g., electrode) such that it can conform easily to the contours of the body surface (see paragraphs [0001, 0012, 0037, 0045, 0052] by Brockway).
15. Claim 68 is rejected under 35 U.S.C. 103 as being unpatentable over Bhavaraju et al. in view of Brownhill et al., further in view of Brockway and Cheng et al.
Regarding claim 68, Bhavaraju in view of Brownhill suggests the method of claim 32. Brownhill teaches wherein the skin-wearable printed sensor comprises at least two electrodes (the one or more sensors 406 may be printed onto the fabric of the garment or compression apparatus 402 which is applied to animal’s body [0037, 0249, 0276, FIG. 4A]. Specifically, the one or more sensors 406 may include conductivity sensors and/or EMG sensors [0251]. Furthermore, the conductivity sensors may include electrodes [0230, 0251]).
Bhavaraju and Brownhill do not explicitly teach wherein the skin-wearable printed sensor comprises:
a conductive flexible film; and
an elastomeric substrate.
The prior art by Brockway is analogous to Bhavaraju, as they both teach physiological sensors or electrodes ([0001]).
Brockway teaches wherein skin-wearable printed sensor comprises a conductive flexible film (the electrode sensing surface is constructed of a thin flexible sheet or film 200 with a conductive surface [0045]).
The prior art by Cheng is analogous to Bhavaraju, as they both teach sensing electrodes that are coupled to a subject ([0049, 0075]).
Cheng teaches wherein the skin-wearable printed sensor comprises:
an elastomeric substrate (the sensor patch 200 may comprise a plurality of sensing electrodes 204 that are printed on an elastic substrate 202 [0044, 0049, 0059, 0075]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify the skin-wearable printed sensor suggested by Bhavaraju in view of Brownhill to comprise a conductive flexible film, as taught by Brockway. The advantage of such modification will improve the conductivity of the sensor (see paragraph [0045] by Brockway). Furthermore, it would have been obvious to a person having ordinary skill in the art to modify the skin-wearable printed sensor suggested by Bhavaraju in view of Brownhill to comprise an elastomeric substrate, as taught by Cheng. This modification is beneficial, as an elastomeric substrate can conform to various contours and/or swelling (e.g., bumps) of the skin surface (see paragraphs [0044, 0059, 0111]).
16. Claim 69 is rejected under 35 U.S.C. 103 as being unpatentable over Bhavaraju et al. in view of Brownhill et al., Brockway, Cheng et al., and further in view of Gao et al.
Regarding claim 69, Bhavaraju in view of Brownhill, Brockway, and Cheng suggests the method of claim 68. Specifically, Brockway teaches wherein the electrodes comprise a graphene layer ([0011-0012, 0052]). Meanwhile, Cheng teaches a polyimide (PI) layer (the elastomeric substrate 202 may include a polyimide layer [0044, 0061]).
Bhavaraju, Brownhill, Brockway, and Cheng do not explicitly teach wherein the graphene layer of the electrodes is in contact with the polyimide layer.
The prior art by Gao is analogous to Bhavaraju, as they both teach sensing electrodes that are configured to monitor a biological signal ([abstract, 0052, 0066]).
Gao teaches wherein the graphene layer of electrodes is in contact with polyimide layer (the multimodal sensing layer 120 includes a polyimide film or substrate [0006, 0055]. Meanwhile, the graphene electrode 130 is laser scribed or engraved onto the polyimide film of the multimodal sensing layer 120 [0006, 0055, 0086]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify the graphene layer and the polyimide layer suggested by Bhavaraju in view of Brownhill, Brockway, and Cheng to contact each other, as taught by Gao. This modification is beneficial, as it may enhance the sensor’s detection of vital signals from the patient (see paragraphs [0006, 0052, 0055, 0086] by Gao).
Allowable Subject Matter
17. Claims 14, 65-66, and 70 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims and if the 101 rejections noted above was overcome.
The following is a statement of reasons for the indication of allowable subject matter: The Examiner has provided an explanation below that describes how the prior art of record fails to suggest the corresponding claims.
Regarding claim 14, Brownhill in view of Brockway, Jayalth, Bhavaraju, and Jacobs suggests the system of claim 13. Brownhill teaches wherein the injury comprises a muscle injury (the compression apparatus 402 comprises one or more sensors 406 (e.g., electromyography sensors) that are configured to detect muscle activity at the injured or wounded site of the animal’s body [0035-0036, 0258, 0276, 0297]. Specifically, the processor 404 may monitor the electromyography (EMG) data from the sensors 406 to determine if the injured or wounded location is healing [0258, 0276, 0297]).
Brownhill, Brockway, Jayalth, Bhavaraju, and Jacobs do not explicitly teach wherein the injury comprises biopsy punch-induced masseter muscle injury.
The Examiner further concludes that the prior art does not provide the requisite teaching, suggestion, and motivation to suggest the recited claim limitations. Therefore, the inventive features recited in the pending claims are not disclosed by the prior art and are not suggested by an obvious combination of the most analogous prior art elements.
Regarding claim 65, Brownhill in view of Brockway, Jayalth, Bhavaraju, and Jacobs suggests the system of claim 13. Brownhill teaches the animal model (the compression apparatus 402 comprises one or more sensors 406 (e.g., electromyography sensors) that are configured to detect muscle activity at the injured or wounded site of the animal’s body [0035-0036, 0258, 0276, 0297]. Specifically, the processor 404 may monitor the electromyography (EMG) data from the sensors 406 to determine if the injured or wounded location is healing [0258, 0276, 0297]).
Brownhill, Brockway, Jayalth, Bhavaraju, and Jacobs do not explicitly teach wherein the animal model is a craniofacial VML model.
The Examiner further concludes that the prior art does not provide the requisite teaching, suggestion, and motivation to suggest the recited claim limitations. Therefore, the inventive features recited in the pending claims are not disclosed by the prior art and are not suggested by an obvious combination of the most analogous prior art elements.
Regarding claim 66, Bhavaraju in view of Brownhill suggests the method of claim 32. Brownhill teaches wherein the injury comprises a muscle injury (the compression apparatus 402 comprises one or more sensors 406 (e.g., electromyography sensors) that are configured to detect muscle activity at the injured or wounded site of the animal’s body [0035-0036, 0258, 0276, 0297]. Specifically, the processor 404 may monitor the electromyography (EMG) data from the sensors 406 to determine if the injured or wounded location is healing [0258, 0276, 0297]).
Bhavaraju and Brownhill do not explicitly teach wherein the injury comprises biopsy punch-induced masseter muscle injury.
The Examiner further concludes that the prior art does not provide the requisite teaching, suggestion, and motivation to suggest the recited claim limitations. Therefore, the inventive features recited in the pending claims are not disclosed by the prior art and are not suggested by an obvious combination of the most analogous prior art elements.
Regarding claim 70, Bhavaraju in view of Brownhill suggests the method of claim 32. Brownhill teaches the animal model (the compression apparatus 402 comprises one or more sensors 406 (e.g., electromyography sensors) that are configured to detect muscle activity at the injured or wounded site of the animal’s body [0035-0036, 0258, 0276, 0297]. Specifically, the processor 404 may monitor the electromyography (EMG) data from the sensors 406 to determine if the injured or wounded location is healing [0258, 0276, 0297]).
Bhavaraju and Brownhill do not explicitly teach wherein the animal model is a craniofacial VML model.
The Examiner further concludes that the prior art does not provide the requisite teaching, suggestion, and motivation to suggest the recited claim limitations. Therefore, the inventive features recited in the pending claims are not disclosed by the prior art and are not suggested by an obvious combination of the most analogous prior art elements.
Conclusion
18. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSHUA BRENDON SOLOMON whose telephone number is (571)270-7208. The examiner can normally be reached on 7:30am -4:30pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Niketa Patel can be reached on (571)272-4156. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see https://ppair-my.uspto.gov/pair/PrivatePair. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JOSHUA BRENDON SOLOMON/Examiner, Art Unit 3792
Prosecution Insights