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 .
2. 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
3. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 08/06/2025 has been entered.
Response to Arguments
4. Applicant’s arguments with respect to claim(s) 1-7 and 9-17 have been considered but are moot because the new ground of rejection does not rely on any reference or combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Rejections - 35 USC § 112
5. Claim 12 was previously rejected under 35 U.S.C. 112(b) as being indefinite. However, Claim 12 has been amended to overcome the deficiencies. Therefore, the rejection is withdrawn.
Claim Rejections - 35 USC § 103
6. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
7. Claims 1-4, 6, 9-11, and 13-17 are rejected under 35 U.S.C. 103 as being unpatentable over Carabajal U.S. 2018/0214161 (herein referred to as “Carabajal”), and in view of Kaib U.S. 2017/0143977 (herein referred to as “Kaib”) and Parris U.S. 8,690,835 (herein referred to as “Parris”).
8. Regarding Claim 1, Carabajal teaches a biosensory garment (Figs. 1A-1C, 3 and Fig. 11A, see at least ref nums 1102, 1103, 1104, 1105, 1108, etc.) comprising:
a. one or more wearable portions (Fig. 1A, ref num 101; Fig. 11A, ref nums 1102, 1103, 1104, 1105, 1108) which include inflatable segments (Fig. 1A, ref num 110; each wearable portion in Fig. 11A has an inflatable segment) associated with an air supply (Fig. 3, ref num 320 = air supply routed to the inflatable segments, ref nums 310, 311, 312…and 319) and one or more microprocessor controlled air valves specially adapted to inflate and deflate and maintain inflation pressure of the inflatable segments (Fig. 3, ref nums 340, 341, 342…349 = air valves; para 0040) to control blood flow or to operate as an occlusive tourniquet (para 0053, 0071, 0080);
b. the one or more wearable portions able to be attached together (Fig. 13, ref nums 1310, 1311, 1312, and 1313 are attached to together via ref num 1301);
d. the one or more portions having at least one physiological sensor in contact with the wearer's body (Fig. 15, ref num 1560, 1562; para 0046);
e. a central processor adapted to remotely receive signals from the at least one physiological sensor (Fig. 15, ref num 1570; para 0070);
f. the central processor to process and remotely transmit sensor information to a command computer (Fig. 15, ref num 1575 = command computer; para 0070);
g. wherein in operation, the physical condition of the wearer can be monitored in real time or recorded over a period of time by the command computer in facilitating any medical intervention or ongoing recovery or rehabilitation of the wearer (para 0095; Fig. 24, ref num 2420; para 0097; Fig. 25, ref nums 2530, 2540, 2550, 2560, 2570); and,
g. wherein, via the central processor, the command computer is able to coordinate and control the operation of air valves in order to inflate and deflate the inflatable segments (para 0037, “each of the at least one switch may be configured to operate one of the at least one valve”; para 0038, “switch configured to cause inflation of the inflatable chamber”; para 0046, “the at least one processing unit may be configured to communicate at least one command to at least one of at least one switch. The at least one command may be based at least in part on at least one of the at least one physiological signal”; para 0071, 0073; also see Fig. 22; para 0089).
Carabajal fails to teach (b) the one or more wearable portions are attached together by releasable fasteners and wherein the one or more wearable portions can be individually removed to permit access to various parts of a wearer's body; and, (c) the one or more wearable portions comprising removable sections or panels to permit access to a part of the wearer’s body that is covered by a particular wearable portion of the one or more wearable portions without requiring removal of the particular wearable portion.
Kaib teaches a biosensory garment of analogous art (Fig. 5A; para 0196) that comprises one or more wearable portions (Figs. 13A and 13B comprise a plurality of side portions, ref nums 1304, a front portion, ref num 1308, and a rear portion, ref num 1310) which are attached together by releasable fasteners (Fig. 13A, ref num 1302, 1306; para 0226; para 0121 “one or more of the anterior, posterior, side and/or shoulder portions may be independent and separable from each other”). The one or more wearable portions can be individually removed to permit access to various parts of a wearer’s body (para 0121, 0132, 0138). By having the wearable portions releasably attached to one another allows for personalization of the device for comfort of wear, while also allowing for the modular configuration to utilize the biosensory components at various body parts as needed (para 0117, 0121). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the one or more wearable portions of the biosensory garment taught by Carabajal to include releasable fasteners to attach the wearable portions, as this provides customized configurations of the biosensory device.
Parris teaches a garment of analogous art (Figs. 1 and 8), wherein the garment comprises one or more wearable portions (Fig. 2, ref nums 12, 18A, 18B) attached together (Fig. 2, ref nums 26 attach ref nums 18A and 18B together; Col. 3, lines 41-42, “the front and back portions 18, 12 are joined at sides thereof”). The one or more wearable portions comprise removable sections or panels (Fig. 8, ref nums 42’ and 42”; Col. 4, lines 34-36, “flaps 42’ and 42” may be releasably attached, by which is meant that the flap may be non-destructably detached”; Col. 5, lines 40-41, “flaps 42’, 42” may be detachably attach to first subportion 18A”) to permit access to a part of the wearer’s body that is covered by a particular wearable portion of the one or more wearable portions (Fig. 8, ref num 34 shows the access to the wearer’s body; Col. 4 lines 38-42, describes the covering and not covering of the access opening of ref num 34) without requiring removal of the particular wearable portion (see Fig. 8, 8A, 8B, ref nums 42’ and 42” are removed without removing ref num 18A). While this type of configuration provides the same expected result of access to the wearer (see at least abstract), it also provides customization to the garment depending on the access required. For example, it may provide access to medical equipment attached to the wearer, and by having sections/panels removable from the wearable portions, the size of these sections/panels may be tailored to the type of equipment (Col. 5, lines 35-41). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified Carabajal to include removable sections/panels to the one or more wearable portions in order to provide the same expected result of providing access to the wearer, as well as provide the advantage of tailoring the garment to said wearer.
9. Regarding Claim 2, Carabajal teaches the one or more wearable portions comprises a single or one piece wearable portion (para 0038, “The at least one tourniquet may be at least partially coupled to a suit, a uniform, a piece of body armor, an article of clothing, combinations thereof, and/or the like”).
10. Regarding Claim 3, Carabajal teaches the one or more wearable portions comprises two wearable portions of a top or shirt portion and a bottom or pants portion (para 0038, also see Figs. 11A, 11B, 12, and 13 where the wearable portions comprise of a top and bottom portion).
11. Regarding Claim 4, Carabajal teaches the one or more wearable portions comprises two or more wearable portions (para 0038, Figs. 11A, 11B, 12, and 13) but fails to teach the wearable portions are attachable together with releasable fastener including hook and eye fasteners, Velcro, press studs, magnetic studs or any other releasable fastening means.
Kaib teaches a biosensory garment of analogous art (Fig. 5A; para 0196) that comprises two or more wearable portions (Figs. 13A and 13B comprise a plurality of side portions, ref nums 1304, a front portion, ref num 1308, and a rear portion, ref num 1310) which are attached together by releasable fasteners (Fig. 13A, ref num 1302, 1306; para 0226, 0229; para 0121 “one or more of the anterior, posterior, side and/or shoulder portions may be independent and separable from each other”). The one or more wearable portions can be individually removed to permit access to various parts of a wearer’s body (para 0121, 0132, 0138). By having the wearable portions releasably attached to one another allows for personalization of the device for comfort of wear, while also allowing for the modular configuration to utilize the biosensory components at various body parts as needed (para 0117, 0121). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the one or more wearable portions of the biosensory garment taught by Carabajal to include releasable fasteners to attach the two or more wearable portions, as this provides customized configurations of the biosensory device.
12. Regarding Claim 6, Carabajal teaches the at least one or more physiological sensor include ECG, body temperature, subcutaneous blood flow, blood pressure, oximetery, galvanic skin response or other non-invasive sensor (para 0046).
13. Regarding Claim 9, Carabajal teaches the air supply includes an air pump (para 0041).
14. Regarding Claim 10, Carabajal teaches the air supply includes a cylinder of compressed gas (para 0041).
15. Regarding Claim 11, Carabajal teaches the central processor transmits information from the at least one or more physiological sensor to the command computer over a wireless personal network area protocol (para 0047, “wirelessly communicated”; para 0048 and 0105) and wherein the command computer can comprise a remote server or smart device including a mobile phone, personal digital assistance, laptop or tablet computer (Figs. 19A, 19B, ref nums 1900, 1901 = command computer).
16. Regarding Claim 13, Carabajal teaches there is a portable rechargeable battery power supply to operate the at least one or more physiological sensor, the central processor, the air supply or the one or more microprocessor controlled air valves (para 0069, 0074, 0080; implicit that the battery is portable since the device/power source is portable/wearable).
17. Regarding Claim 14, Carabajal teaches the command computer coordinates and controls the operation of the at least one or more physiological sensor via the central processor (para 0089, “the processing unit 2270 may be configured to communicate with the at least one physiological sensor”; Fig. 22).
18. Regarding Claim 15, Carabajal teaches the ambulatory acquisition of vital signs and health status monitoring external to a clinical environment over extend time period in the recovery and treatment of an injured wearer (para 0083, 0090-0091; Fig. 20).
19. Regarding Claim 16, Carabajal teaches that the biosensory garment is used as a military garment to facilitate the acquisition of vital signs and health status of combatants during normal operational duties and wherein the vital signs and health status information can also be used to anticipate any necessary medical intervention or treatment by first responders or medical prior to rescue and evacuation of an injured combatant (para 0002-0003, 0038, 0047, 0083, 0090-0091, 0110).
20. Regarding Claim 17, Carabajal teaches the garment is used as an ambulatory sports activity and fitness monitoring device in the training and optimization of athletic performance and in the treatment and recovery of an athlete from a sports injury (para 0002-0003, 0038, 0083, 0090-0091, 0110).
21. Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Carabajal, Kaib, and Parris, and further in view of Longinotti-Buitoni U.S. 2018/0067516 (herein referred to as “Longinotti-Buitoni”).
22. Regarding Claim 5, Carabajal fails to teach the one or more wearable portions comprises a close fitted hood or balaclava portion including EEG sensors adapted to be in contact with the head of the wearer.
Longinotti-Buitoni teaches a biosensory garment of analogous art (Fig. 22A and 22C), wherein the garment comprises a hood (see Fig. 22A, ref num 2205) that includes an EEG sensor adapted to be contact with the head of the wearer (Fig. 22A, ref num 2209, para 0438; para 0057). The EEG measures electrical activity of the brain (para 0287), which provides the user with feedback that may be used to treat the patient (para 0307). Therefore, it would have been obvious to one of ordinary skill in art before the effective filing date of the claimed invention to have further modified the at least one or more wearable portions of Carabajal to include a hood, as well an EEG sensor that is disposed in the hood of the wearable portion in order to collected data about the brain to better formulate a treatment for the patient based on the feedback from the EEG.
23. Claims 7, 18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Carabajal, Kaib, and Parris, and further in view of Anderson U.S. 2020/0337563 (herein referred to as “Anderson”).
24. Regarding Claim 7, Carabajal fails to teach a transceiver receptive to signals from an implanted sensor such as a cardiac pacemaker and wherein the central processor transmits the signal information received by the transceiver to the command computer.
Anderson teaches a biosensory wearable device of analogous art (Fig. 1B), the device comprising at least one or more wearable portions (Figs. 1A, 6A, and 6B, ref num 122) and a transceiver (Fig. 7, ref num 708). The transceiver is receptive to signals from an implanted sensor such as a cardiac pacemaker (Fig. 1A, ref nums 102a/102b = implanted sensor/cardiac pacemaker; para 0012, 0036; the implanted sensor communicates with the wearable device via electrodes, such as ref nums 115a/115b in Fig. 1A and/or ref nums 634 in Fig. 6B; para 0108, “amplifier and filter circuitry 740 which is coupled to at least two electrodes 634”; para 0112, “amplifier and filter circuitry 740 amplify and filter conductive communication signals that are transmitted through patient tissue by an IMD that is implanted within the patient that is wear the device 122”). The device also comprises a central processor (Fig. 7, ref num 712) and a command computer (Fig. 1, ref num 139; para 0113), such that the central processor transmits the signal information received by the transceiver to the command computer (para 0113). This communication between a transceiver in the wearable device and an implanted sensor of the wearer allows for continuous monitoring of different parameters, such as arterial/blood pressure, of the patient (para 0001, 0009-0010). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Carabajal to include a transceiver that is receptive to signals from an implanted sensor, as this provides an improved monitoring system that allows for chronically monitoring a patient’s vitals that are collected via the implanted device.
25. Regarding Claim 18, Carabajal teaches the portable rechargeable battery power supply to operate the central processor, the transceiver, the air supply, or the one or more microprocessor controlled air valves (para 0069, 0074, 0080; implicit that the battery is portable since the device/power source is portable/wearable).
26. Regarding Claim 20, Carabajal fails to teach the transceiver of claim 7, and therefore fails to teach the command computer coordinates and controls the operation of the transceiver via the central processor.
Anderson teaches a biosensory wearable device of analogous art (Fig. 1B), the device comprising at least one or more wearable portions (Figs. 1A, 6A, and 6B, ref num 122) and a transceiver (Fig. 7, ref num 708). The transceiver is receptive to signals from an implanted sensor such as a cardiac pacemaker (Fig. 1A, ref nums 102a/102b = implanted sensor/cardiac pacemaker; para 0012, 0036; the implanted sensor communicates with the wearable device via electrodes, such as ref nums 115a/115b in Fig. 1A and/or ref nums 634 in Fig. 6B; para 0108, “amplifier and filter circuitry 740 which is coupled to at least two electrodes 634”; para 0112, “amplifier and filter circuitry 740 amplify and filter conductive communication signals that are transmitted through patient tissue by an IMD that is implanted within the patient that is wear the device 122”). The device also comprises a central processor (Fig. 7, ref num 712) and a command computer (Fig. 1, ref num 139; para 0113), such that the central processor transmits the signal information received by the transceiver to the command computer (para 0113). The implanted sensor also receives operating parameters from the wearable device (para 0153; Fig. 10), such that the wearable device receives the operating parameters from the command computer via the central processor (para 0153, 0087, 0084, 0039). This communication between the command computer, a transceiver in the wearable device, and an implanted sensor of the wearer allows for continuous monitoring of different parameters, such as arterial/blood pressure, of the patient (para 0001, 0009-0010). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Carabajal to include a transceiver that is receptive to signals from an implanted sensor, and that the command computer controls operations of the transceiver, as this provides an improved monitoring system that allows for chronically monitoring a patient’s vitals that are collected via the implanted device.
27. Claims 12 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Carabajal, Kaib, and Parris, and further in view of Gueritee U.S. 2021/0282472 (herein referred to as “Gueritee”).
28. Regarding Claim 12, Carabajal fails to teach that there are one or more heating elements associated with the one or more wearable portions to maintain or increase body temperature as required.
Gueritee teaches a biosensory garment of analogous art (Fig. 1, ref num 110; para 0034, “wearable article 110”), comprising one or more wearable portions (ref num 110 is a wearable portion) and one or more heating elements (Fig. 1, ref num 104; para 0034, “temperature adjusting element 104”). The one or more heating elements are associated with the wearable portion (para 0034, 0038) to maintain or increase body temperature as required (para 0038, “temperature adjusting element provides heat to increase the skin temperature of the user”). The one or more heating elements are distributed across multiple locations of the wearable portions of the garment (para 0182-0183) which provides the advantage of selectively activating the heating device at the desired location that is below a desired temperature, reducing the power consumption of the device (para 0186). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Carabajal to include one or more heating elements associated with the one or more wearable portions, as this provides the advantage of selective heating portions of the garment, as well as reducing the power consumption of the heating elements and, ultimately, the device.
29. Regarding Claim 19, Carabajal teaches the portable rechargeable battery power supply to operate the central processor, the one or more heating elements, the air supply, or the one or more microprocessor controlled air valves (para 0069, 0074, 0080; implicit that the battery is portable since the device/power source is portable/wearable).
Conclusion
30. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNIE L SHOULDERS whose telephone number is (571)272-3846. The examiner can normally be reached Monday-Friday (alternate Fridays) 8AM-5PM EST.
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/ANNIE L SHOULDERS/Examiner, Art Unit 3794