DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 December 22, 2025 has been entered. By this amendment, claims 1 and 16 are amended, claims 8 and 9 are cancelled, and claims 1-7, 10-12, and 14-22 are now pending in the application.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-3, 5, 6, 10-12, and 14-22 are rejected under 35 U.S.C. 103 as being unpatentable over Hyde (U.S. 2017/0258995, previously cited) in view of Dupelle et al. (U.S. 2011/0313482). Regarding claim 1, Hyde discloses a wearable physical health testing system, comprising: an article of clothing 102/102a/102b/107/102c/502a/502b/502c/502c’ configured to be worn by a user (see Figures 1A-2C and 5A-5C); a communications hub 119 (“the controller 112 can include an interface 119 operably coupled thereto and configured to communicate with and receive sensed data 109 from the one or more sensors, signals 113 from the processor, or input from a user (e.g., the subject or medical professional)”, paragraph [0126]) integrated into the article of clothing (“the controller 112 can be mounted on, attached to, embedded in, or housed in the flexible compression garment or a wearable device”, paragraph [0125]); and a plurality of physical health testing devices (sensors 108/108’) integrated into the article of clothing and communicatively coupled to the communications hub (see Figures 1A-2C, 4, and 5A-5C), wherein the plurality of physical health testing devices includes a plurality of electrocardiogram (ECG) electrodes (“the one or more additional types of sensors can include one or more heart rate sensors that are configured to sense a heart rate of the subject 106 or one or more electrocardiography sensor”, paragraph [0079]); and an adjustment assembly integrated into the article of clothing and configured to adjust a position of at least one of the plurality of physical health testing devices relative to the user such that the at least one physical health testing device is in alignment with a corresponding body portion of the user for detecting accurate health data (“the wearable device 107 can be attached to the body part 105 by an attachment device (e.g., adhesive, hook and loop material, clips, or other suitable device)”, paragraph [0036], and “the wearable device 107′ can be configured as a wrist band having an adjustable strap thereon, wherein the adjustable strap can be adjusted out to allow the wrist band to fit around a portion of the leg of the subject, or around the head of the subject 106”, paragraph [0149]), wherein each physical health testing device of the plurality of physical health testing devices is configured to automatically generate physical health data of the user and to transmit generated physical health data to the communications hub (“The processor 114 can be configured to receive sensed data 109 from one or more sensors 108 and determine if the sensed data 109 indicates a change (e.g., initiation, increase, decrease, or termination) or maintenance of the current delivery state of the one or more medicaments is required. The processor 114 can access the memory 116 via an operable connection 115 therebetween. The operable connection 115 can be a wireless connection (e.g., Bluetooth, Wi-Fi, infrared beams, etc.) or hardwired connection. The processor 114 can receive and process the one or more sensed signals 109 (e.g., as relayed through the interface 119). The processor 114 can send the sensed or processed data to the memory 116 for storage via the operable connection 115.”, paragraph [0126]). Further, Hyde discloses that the article of clothing has a slot and/or pouch 110 sized and shaped to retain a gel pack with electrically conductive gel (see Figures 1A-2C and 5A-5C and “The fluid can be a mixture of one or more medicaments, such as in a solution, a dispersion, an emulsion, a suspension, a gel, or any of mixture of the foregoing substances. In an embodiment, the one or more medicaments can be dispensed as a solid (e.g., a dissolvable solid in an emulsion or bound to the surface of a protrusion).”, paragraph [0033], and “In an embodiment, the one or more reservoirs can include a bag, a tube (e.g., a syringe), a chamber, a porous medicament bearing material (e.g., a fabric, a gel, or a sponge), each of which can be constructed of or confined within a medically sterile material (e.g., a rigid or flexible polymer or plastic, glass, etc.).”, paragraph [0090]). However, Hyde fails to disclose that the slot and/or pouch is positioned beneath at least one of the plurality of ECG electrodes and the adjustment assembly is configured to compress the article of clothing to break the gel packet and distribute the electrically conductive gel between one or more of the plurality of ECG electrodes. Dupelle teaches electrical contact electrodes 120 contained in a wearable housing 205 and electrically conductive gel packs disposed beneath the electrodes that can break to distribute the electrically conductive gel between one or more of the plurality of ECG electrodes (“gel may be placed in a series of packs disposed on stimulation electrodes 120. In this example, these gel packs can burst when applied to the subject or when stimulation electrodes 120 are activated, dispersing the gel between the subject and stimulation electrodes 120.”, paragraph [0044]), in order to enhance the electric conductivity of the electrodes (“intervening elements to facilitate conductivity” and “a conductive fluid such as a gel or a conductive solid such as a paste can be applied to the conductive plates of stimulation electrodes 120, or to the subject's body at the location where stimulation electrodes 120 are brought into contact with the subject (e.g., a limb)”, paragraph [0044]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Hyde to position the slot and/or pouch beneath at least one of the plurality of ECG electrodes and the adjustment assembly is configured to compress the article of clothing to break the gel packet and distribute the electrically conductive gel between one or more of the plurality of ECG electrodes, as taught by Dupelle, in order to enhance conductivity of the electrodes and facilitate electrical connection to the patient’s body.
Regarding claim 2, Hyde discloses that the adjustment assembly is configured to compress the wearable system about the user (“the wearable device 107 can be attached to the body part 105 by an attachment device (e.g., adhesive, hook and loop material, clips, or other suitable device)”, paragraph [0036], and “the wearable device 107′ can be configured as a wrist band having an adjustable strap thereon, wherein the adjustable strap can be adjusted out to allow the wrist band to fit around a portion of the leg of the subject, or around the head of the subject 106”, paragraph [0149]).
Regarding claim 3, Hyde discloses that the adjustment assembly includes one or more adjustment motors and one or more adjustment cables (“the one or more actuators 354 include a gear system configured to constrict or dilate (e.g., tighten or loosen) the at least a portion of the at least one flexible compression garment 302c. For example, the gear system can include a reel having gears therein and lacing connected therethrough.”, paragraph [0117]).
Regarding claim 5, Hyde discloses that the plurality of physical health testing devices includes at least one blood pressure and/or heart rate cuff configured to generate blood pressure and/or heart rate health data of the user (“the one or more sensors 108 can be located in the flexible compression garment at a position therein configured to correspond to an anatomical feature of the subject (e.g., at a joint, at a point suitable for determining a pulse or blood pressure, at sweat gland, etc.) when worn by the subject”, paragraph [0051]).
Regarding claim 6, Hyde discloses that the plurality of ECG electrodes includes one or more redundant ECG electrodes (Figure 2A shows at least five electrodes 108/108’, wherein more than one can be considered “redundant”).
Regarding claim 10, Hyde discloses that the plurality of physical health testing devices includes one or more stethoscope microphones configured to generate heart and/or lung activity health data of the user (“sensor 108 can be configured to detect pressure or sound indicating a pulse of the subject in a specific location.”, paragraph [0047]).
Regarding claims 11 and 12, Hyde discloses the invention substantially as claimed, including a stethoscope positioned at a desired location (“sensor 108 can be configured to detect pressure or sound indicating a pulse of the subject in a specific location.”, paragraph [0047], where the “specific location” is the desired location as claimed), but fails to disclose that the one or more stethoscope microphones include at least two stethoscope microphones. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to include at least two stethoscope microphones, including a redundant stethoscope microphone, as it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. MPEP 2144.04
Regarding claim 14, Hyde discloses a user device in wired and/or wireless communication with the communications hub and/or with individual physical health testing devices of the plurality of physical health testing devices, wherein- the user device includes a display and a software application, using the display, the software application is configured to present to the user (i) instructions for performing a physical exam using the plurality of physical health testing devices and/or (ii) health data generated by at least one physical health testing device of the plurality of physical health testing devices (“In an embodiment, the controller 112 can include or be a remote device separate from the flexible compression garment and the wearable device. For example, the remote device can include a computer (e.g., a desktop or laptop computer), a tablet, a smartphone, a communication device, or another electronic device. The remote device can be accessed and used by the subject or another person, such as a medical professional.”, paragraph [0125]).
Regarding claim 15, Hyde discloses one or more remote servers and/or databases, wherein the communications hub and/or a/the user device is/are configured to transmit all or a subset of the generated physical health data to the one or more remote servers and/or databases for storage in one or more database entries associated with an account of the user (“In an embodiment, the controller 112 can include or be a remote device separate from the flexible compression garment and the wearable device. For example, the remote device can include a computer (e.g., a desktop or laptop computer), a tablet, a smartphone, a communication device, or another electronic device. The remote device can be accessed and used by the subject or another person, such as a medical professional.”, paragraph [0125]).
Regarding claim 16, Hyde discloses a method for generating a physical exam report of a user, the method comprising: generating physical health data of the user using a wearable physical health testing system, wherein the wearable system includes an article of clothing 102/102a/102b/107/102c/502a/502b/ 502c/502c’, 119 (“the controller 112 can include an interface 119 operably coupled thereto and configured to communicate with and receive sensed data 109 from the one or more sensors, signals 113 from the processor, or input from a user (e.g., the subject or medical professional)”, paragraph [0126]) integrated into the article of clothing (“the controller 112 can be mounted on, attached to, embedded in, or housed in the flexible compression garment or a wearable device”, paragraph [0125]), and a plurality of physical health testing devices (sensors 108/108’) integrated into the article of clothing and communicatively coupled to the communications hub(see Figures 1A-2C, 4, and 5A-5C), and an adjustment assembly integrated into the article of clothing (“the wearable device 107 can be attached to the body part 105 by an attachment device (e.g., adhesive, hook and loop material, clips, or other suitable device)”, paragraph [0036], and “the wearable device 107′ can be configured as a wrist band having an adjustable strap thereon, wherein the adjustable strap can be adjusted out to allow the wrist band to fit around a portion of the leg of the subject, or around the head of the subject 106”, paragraph [0149]), wherein the plurality of physical health testing devices includes a plurality of electrocardiogram (ECG) electrodes (“the one or more additional types of sensors can include one or more heart rate sensors that are configured to sense a heart rate of the subject 106 or one or more electrocardiography sensor”, paragraph [0079]), and each physical health testing device of the plurality of physical health testing devices is configured to automatically generate a corresponding portion of the physical health data of the user and to transmit the corresponding portion of the generated health data to the communications hub (“The processor 114 can be configured to receive sensed data 109 from one or more sensors 108 and determine if the sensed data 109 indicates a change (e.g., initiation, increase, decrease, or termination) or maintenance of the current delivery state of the one or more medicaments is required. The processor 114 can access the memory 116 via an operable connection 115 therebetween. The operable connection 115 can be a wireless connection (e.g., Bluetooth, Wi-Fi, infrared beams, etc.) or hardwired connection. The processor 114 can receive and process the one or more sensed signals 109 (e.g., as relayed through the interface 119). The processor 114 can send the sensed or processed data to the memory 116 for storage via the operable connection 115.”, paragraph [0126]); adjusting, via the adjustment assembly, a position of at least one of the plurality of physical health testing devices relative to the user such that the at least one physical health testing device is in alignment with a corresponding body portion of the user for detecting accurate health data (“the wearable device 107 can be attached to the body part 105 by an attachment device (e.g., adhesive, hook and loop material, clips, or other suitable device)”, paragraph [0036], and “the wearable device 107′ can be configured as a wrist band having an adjustable strap thereon, wherein the adjustable strap can be adjusted out to allow the wrist band to fit around a portion of the leg of the subject, or around the head of the subject 106”, paragraph [0149]); comparing at least a portion of the generated physical health data of the user to one or more corresponding predetermined ranges of healthy data values (“comparing current sensed data with baseline or model sensed data for the same at least one characteristic.”, paragraph [0058]); and based on the comparison(s), generating a physical exam report that includes all or a subset of the generated health data and that indicates any generated physical health data outside of the one or more corresponding predetermined range(s) of healthy data values (“in an embodiment, the controller 112 (e.g., processor 114) is configured to determine if a body part of the subject is fatigued (e.g., via a comparison one or more sensor data over time indicative of a slowing pace or activity level, or by detecting a depletion of chemical components in a body fluid), swollen (e.g., via localized pressure applied to one or more sensors), injured, or strained (e.g., sensor data indicating that the subject is favoring a body part). Responsive to the determination, the controller 112 (e.g., processor 114) is configured to send a signal 113 to direct the one or more actuators (not shown) in the one or more medicament dispensers 110 to selectively manage delivery of the one or more medicaments.”, paragraph [0139]). However, Hyde fails to disclose compressing, via the adjustment assembly, the article of clothing to break a gel backet with electrically conductive gel and distribute the electrically conductive gel between one or more of the plurality of ECG electrodes and the user. Dupelle teaches electrical contact electrodes 120 contained in a wearable housing 205 and electrically conductive gel packs disposed beneath the electrodes that can break to distribute the electrically conductive gel between one or more of the plurality of ECG electrodes (“gel may be placed in a series of packs disposed on stimulation electrodes 120. In this example, these gel packs can burst when applied to the subject or when stimulation electrodes 120 are activated, dispersing the gel between the subject and stimulation electrodes 120.”, paragraph [0044]), in order to enhance the electric conductivity of the electrodes (“intervening elements to facilitate conductivity” and “a conductive fluid such as a gel or a conductive solid such as a paste can be applied to the conductive plates of stimulation electrodes 120, or to the subject's body at the location where stimulation electrodes 120 are brought into contact with the subject (e.g., a limb)”, paragraph [0044]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Hyde to include compressing, via the adjustment assembly, the article of clothing to break a gel backet with electrically conductive gel and distribute the electrically conductive gel between one or more of the plurality of ECG electrodes and the user, as taught by Dupelle, in order to enhance conductivity of the electrodes and facilitate electrical connection to the patient’s body.
Regarding claim 17, Hyde discloses that generating the physical health data of the user using the plurality of physical health testing devices includes: generating blood pressure and/or heart rate health data of the user using a blood pressure and/or heart rate cuff integrated into a sleeve of the article of clothing (“the one or more sensors 108 can be located in the flexible compression garment at a position therein configured to correspond to an anatomical feature of the subject (e.g., at a joint, at a point suitable for determining a pulse or blood pressure, at sweat gland, etc.) when worn by the subject”, paragraph [0051]); generating ECG health data of the user using the plurality of ECG electrodes (“the one or more additional types of sensors can include one or more heart rate sensors that are configured to sense a heart rate of the subject 106 or one or more electrocardiography sensor”, paragraph [0079]); and generating heart and/or lung activity health data of the user using one or more stethoscope microphones of the plurality of physical health testing devices (“sensor 108 can be configured to detect pressure or sound indicating a pulse of the subject in a specific location.”, paragraph [0047]).
Regarding claim 18, Hyde discloses presenting all or a subset of the generated physical health data and/or the generated physical exam report to the user using a software application running on a mobile device of the user (“the method 600 can include indicating or displaying any of the information related to the system (e.g., status of medicament delivery, sensed data, threshold conditions, health condition of the subject, power status of the system, etc.) on the reporting device.”, paragraph [0176]).
Regarding claim 19, Hyde discloses storing all or a subset of the generated health data and/or the generated physical exam report on one or more remote servers and/or databases in one or more database entries associated with an account of the user (“In an embodiment, the controller 112 can include or be a remote device separate from the flexible compression garment and the wearable device. For example, the remote device can include a computer (e.g., a desktop or laptop computer), a tablet, a smartphone, a communication device, or another electronic device. The remote device can be accessed and used by the subject or another person, such as a medical professional.”, paragraph [0125], and “The memory 116 can include a hard disk drive (e.g., magnetic or optical memory storage), solid state memory device, virtual or cloud based memory storage, or any other memory device. The processor 114 can access stored data in the memory 116 for use in processing or other operations. Stored data can include stored sensed data 109, look-up tables, programs (e.g., pre-programmed programs), actuation data corresponding to the selective delivery of one or more medicaments, threshold levels, or other data related to the operation of the system 100 or health care of the subject 106. The stored data can be used to determine if sensed data 109 indicates that a change or maintenance in a delivery state of the one or more medicament dispensers 110 is required. For example, the stored data can include a look-up table which is accessed by the processor 114 to determine if the sensed data 109 indicates that a threshold condition has been met or exceeded. The stored data can include look-up tables or other information (e.g., physiological, environmental, or other information) related to one or more specific subjects or one or more demographics that a subject can be included in. In other embodiments, the stored data can include a program configured to direct the delivery of the one or more medicaments according to the program instructions therein.”, paragraph [0127]).
Regarding claim 20, Hyde discloses that based at least in part on the generated physical exam report, recommending the user consult a healthcare professional; generating a code associated with the user and all or a subset of the generated physical exam report; and/or transmitting the code and/or all or a subset of the generated physical exam report to the healthcare professional (“the method 600 can include indicating or displaying any of the information related to the system (e.g., status of medicament delivery, sensed data, threshold conditions, health condition of the subject, power status of the system, etc.) on the reporting device.”, paragraph [0176]).
Regarding claim 21, Hyde discloses that adjusting comprises adjusting one or more positions of the plurality of ECG electrodes such that individual ones of the plurality of ECG electrodes are at positions on the user's body (the adjustment mechanism of Hyde, as set forth in the independent claim tightens the article clothing against the body of the user and, therefore, positions the plurality of ECG electrodes such that individual ones of the plurality of ECG electrodes are at positions on the user’s body). It is respectfully submitted that the recitation “for capturing an accurate ECG reading of the user's heart” is directed to an intended use recitation that fails to further define the claimed invention over that of the prior art.
Regarding claim 22, Hyde discloses that the plurality of physical health testing devices includes a stethoscope microphone (“sensor 108 can be configured to detect pressure or sound indicating a pulse of the subject in a specific location.”, paragraph [0047]). Further, it is respectfully submitted that the adjusting performed by Hyde, where the article of clothing is tightened against the body of the user would result in adjustment of a position of the stethoscope microphone such that the stethoscope microphone is at a position on the user's body for capturing an accurate PCG recording of the user's heart and lungs.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Hyde (U.S. 2017/0258995, previously cited) in view of Dupelle (U.S. 2011/0313482) as applied to claims 1-3, 5, 6, 10, and 14-22 above, and further in view of Beers (U.S. Patent No. 10,085,517, previously cited). Hyde in view of Dupelle provides the invention substantially as claimed, but fails to disclose that an adjustment motor of the one or more adjustment motors is configured to track an amount of cable drawn into the adjustment motor in a first direction, and wherein the wearable system is configured to determine a shape and/or a size of a corresponding portion of the user based at least in part on the amount of cable drawn into the adjustment motor in the first direction. Beers teaches a tensioning system for articles of footwear and articles of apparel (“a tensioning system may not be limited to footwear and in other embodiments a tensioning system could be used with various kinds of apparel, including clothing”, col. 5, ln. 62-64), wherein an adjustment motor is configured to track an amount of cable drawn in to the adjustment motor and determine a shape and/or size of a corresponding portion of the user based at least in part on the amount of cable drawn in (“Methods of digitally tracking tensioning data measured by one or more tension sensors could be used in some embodiments. The average tension of the device could also be tracked, to measure swelling, atrophy, etc.”, col. 31, ln. 58-61). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Hyde in view of Dupelle such that an adjustment motor of the one or more adjustment motors is configured to track an amount of cable drawn into the adjustment motor in a first direction, and wherein the wearable system is configured to determine a shape and/or a size of a corresponding portion of the user based at least in part on the amount of cable drawn into the adjustment motor in the first direction, as taught by Beers, in order to measure swelling or atrophy in a user.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Hyde (U.S. 2017/0258995, previously cited) in view of Dupelle (U.S. 2011/0313482) as applied to claims 1-3, 5, 6, 10, and 14-22 above, and further in view of Lewis (U.S. 2016/0287470, previously cited). Hyde in view of Dupelle provides the invention substantially as claimed, but fails to disclose that the communications hub is configured to determined which ECG electrode of a first group of ECG electrodes of the plurality of ECG electrodes is collecting accurate ECG health data of the user. Lewis teaches a medical device that includes a wearable garment configured to be worn by a user (see Figure 3), including ECG electrodes 312 and a communications hub 200 configured to determine which ECG electrode of a first group of ECG electrodes of the plurality of ECG electrodes is collecting accurate ECG health data of the user (“the heart monitoring protocol care protocol module 700 determines whether the ECG signal integrity is of sufficient quality to support an accurate interpretation (e.g., the ECG signal integrity exceeds a threshold)”, paragraph [0124]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Hyde in view of Dupelle to configure the communications hub to determined which ECG electrode of a first group of ECG electrodes of the plurality of ECG electrodes is collecting accurate ECG health data of the user, as taught by Lewis, as it has been held that combining prior art elements according to known methods to yield predictable results requires only routine skill in the art. KSR Int'l Co. v. Teleflex Inc., 127 S.Ct. 1727, 1742, 82 USPQ2d 1385, 1396 (2007).
Response to Arguments
Applicant’s arguments with respect to claims 1-7, 10-12, and 14-22 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
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/TAMMIE K MARLEN/Primary Examiner, Art Unit 3796