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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/17/2025 has been entered.
Response to Arguments
Applicant’s arguments, see pages 9-12, filed 12/17/2025, with respect to the rejection(s) Claims 1, 11 and 21 (and all pending dependent claims thereof) under 35 U.S.C. § 103 have been fully considered but are not persuasive.
The applicant has argued “In accordance with amended claim 1, the processing unit obtains from the first and second patient-wearable devices information that specifies which sensor types are included on each patient-wearable device and uses such information (in addition to body location) to determine which sensors to turn on/off on each patient wearable device. Lee does not even contemplate such a scenario, since Lee describes universal multimodality sensor modules that are termed "universal" precisely because they all include the same set of sensors. It is not surprising, then, that Lee fails to teach or suggest the passing of information concerning which sensor types are included on each sensor module to computing device 130, let alone that each sensor module can communicate its own sensor types to computing device 130. Felice fails to remedy this shortcoming of Lee with respect to amended claim 1, since Felice describes a system that includes a plurality of wireless electrodes that all include a single EKG sensor. Thus, Felice also fails to teach or suggest the relevant features.” (Emphasis added).
Concerning the disclosure of Lee, the Examiner agrees the contacts within each receiver unit 104 are selectively differentiated attach in different manners to respective modules 102 primarily to specify different locations on the body. However, by extension, this also means the contacts within each receiver unit 104 are designed for and configured for connecting to a universal multimodality sensor module 102, specifically. Lee does not teach the contacts within receiver 104 being configured to attach to any other device other than universal multimodality sensor modules. Therefore, when processor 130 communicates with module 102, whose leads 132 have interpreted the specific contacts (i.e. the processor 130 has received information that specifies the body location to which the patient-wearable device is attached), it also receives information that a multimodal module 102 is attached, which implicitly comprises information about which sensor types are included in the plurality of sensors—namely, the sensor types of the universal multimodality sensor module 102.
Furthermore, the amended claims do not exclude the first plurality of sensors and second plurality of sensors being identical types of sensor modules, as contemplated by Lee. The “information that specifies which sensor types are included in the first plurality of sensors” and “information that specifies which sensor types are included in the second plurality of sensors” can be identical informational sets.
For these reasons, the rejection of the claims under 35 U.S.C. § 103 is maintained.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “processing unit” in claim 1.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim 1 is being interpreted under 35 U.S.C. § 112(f) as it:
Uses the nonce term “unit” for the apparatus performing the specified function
“unit” is linked with the transitional phrase “configured to” and modified by the functional language “obtain from the first patient-wearable device first information that specifies the first body location to which the first patient-wearable device is attached and which sensor types are included in the first plurality of sensors, obtain from the second patient-wearable device second information that specifies the second body location to which the second patient-wearable device is attached and which sensor types are included in the second plurality of sensors, and selectively turn on and off individual ones of the sensors in the first plurality of sensors and the second plurality of sensors based on at least the first information and the second information”.
“unit” is not modified by sufficient structure, material, or acts for performing the claimed function.
This claim will be interpreted in accordance with the disclosure of the applicant on [0081] as one or more microprocessors, microcontrollers, digital signal processors, and/or application specific integrated circuits, and equivalents configured to execute software instructions stored in memory to perform the disclosed computer-implemented algorithm.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 3-7, 9, 11, 13-17, 19, 21, 23-27 and 29 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lee (US 20190313967 A1, hereinafter Lee).
Regarding Claim 1, Lee discloses a system (See Fig. 1), comprising:
a first patient-wearable device (Any element 102, Fig. 1; “a system 100 for monitoring and treating head, spine and body abnormality may include a plurality of universal multimodality sensor modules 102 secured to/within respective receiver units 104”, [0029]) that is attachable to a first body location of a patient (“a) providing a plurality of receiver units wherein each receiver unit is configured to be secured at a selected location on a wearer's body; b) mounting a universal multimodality sensor module comprising a power source, a printed circuit board including a processor, memory and communication module, and a plurality of individual sensors to each respective receiver unit”, [0011]) and configured to detect a pulse condition at the first body location (“each universal multimodality sensor module comprises…a pulse oximeter”, [0012]), the first patient-wearable device comprising a first plurality of sensors (See Fig. 4; element 102 comprises a plurality of sensors);
a second patient-wearable device (Any element 102 not considered the first patient-wearable device, Fig. 1) that is attachable to a second body location of the patient (“a) providing a plurality of receiver units wherein each receiver unit is configured to be secured at a selected location on a wearer's body; b) mounting a universal multimodality sensor module comprising a power source, a printed circuit board including a processor, memory and communication module, and a plurality of individual sensors to each respective receiver unit”, [0011]) and configured to detect a pulse condition at the second body location (“each universal multimodality sensor module comprises…a pulse oximeter”, [0012]), the second patient-wearable device comprising a second plurality of sensors (See Fig. 4; element 102 comprises a plurality of sensors); and
a processing unit (Element 130, Fig. 6) that is communicatively connected to the first patient-wearable device and the second patient-wearable device (“each universal multimodality sensor module 102 may communicate with each other universal multimodality sensor module 102 and/or a computing device 130”, [0030]) and that is configured to obtain from the first patient-wearable device first information (“computing device 130 may include a software application configured to selectively communicate with each individual universal multimodality sensor module 102. Wearer 106 (or a physician) may utilize the application to instruct each universal multimodality sensor module 102 which sensors 114-122 are to be powered and unpowered”, [0032]) that specifies the first body location to which the first patient-wearable device is attached (“leads 132 may also engage contacts within receiver units 104. In accordance with an aspect of the present invention, the contacts within receiver units 104 may be selectively differentiated so that receiver units with specific contacts may be located at specified locations on wearer 106. When universal multimodality sensor module 102 is coupled to a receiver unit 104, leads 132 may interpret the specific contacts whereby processor 124 may selectively control which sensors 114-122 are powered by battery 110 to receive health data from the wearer”, [0032]) and which sensor types are included in the first plurality of sensors (“computing device 130 may include a software application configured to selectively communicate with each individual universal multimodality sensor module 102”, [0032]; receiving information from a module 102 implicitly comprises information about which sensor types are included in the plurality of sensors—namely, the sensor types of a first universal multimodality sensor module 102), obtain from the second patient-wearable device second information (“computing device 130 may include a software application configured to selectively communicate with each individual universal multimodality sensor module 102. Wearer 106 (or a physician) may utilize the application to instruct each universal multimodality sensor module 102 which sensors 114-122 are to be powered and unpowered”, [0032]) that specifies the second body location to which the second patient-wearable device is attached (“leads 132 may also engage contacts within receiver units 104. In accordance with an aspect of the present invention, the contacts within receiver units 104 may be selectively differentiated so that receiver units with specific contacts may be located at specified locations on wearer 106. When universal multimodality sensor module 102 is coupled to a receiver unit 104, leads 132 may interpret the specific contacts whereby processor 124 may selectively control which sensors 114-122 are powered by battery 110 to receive health data from the wearer”, [0032]) and which sensor types are included in the second plurality of sensors (“computing device 130 may include a software application configured to selectively communicate with each individual universal multimodality sensor module 102”, [0032]; receiving information from a module 102 implicitly comprises information about which sensor types are included in the plurality of sensors—namely, the sensor types of a second universal multimodality sensor module 102), and selectively turn on and off individual ones of the sensors in the first plurality of sensors and the second plurality of sensors based on at least the first information and the second information (“computing device 130 may include a software application configured to selectively communicate with each individual universal multimodality sensor module 102. Wearer 106 (or a physician) may utilize the application to instruct each universal multimodality sensor module 102 which sensors 114-122 are to be powered and unpowered”, [0032]).
Regarding Claim 3, Lee discloses the system of claim 1, wherein:
the first plurality of sensors and the second plurality of sensors include a same variety of sensor types (“each universal multimodality sensor module comprises a 9-axis accelerometer, a pulse oximeter, an electromyography (EMG) sensor and a mechanomyography (MMG) sensor”, [0012]).
Regarding Claim 4, Lee discloses the system of claim 3, wherein:
the first plurality of sensors includes at least a first inertial measurement unit (IMU) (“each universal multimodality sensor module comprises a 9-axis accelerometer, a pulse oximeter, an electromyography (EMG) sensor and a mechanomyography (MMG) sensor”, [0012]) and a first acoustic sensor (See element 122 in element 102, Fig. 4; “Additional auxiliary sensors 122 may include an MMG sensor, a force sensor and/or a speaker/microphone”, [0029]); and
the second plurality of sensors includes at least a second IMU (“each universal multimodality sensor module comprises a 9-axis accelerometer, a pulse oximeter, an electromyography (EMG) sensor and a mechanomyography (MMG) sensor”, [0012]) and a second acoustic sensor (See element 122 in element 102, Fig. 4; “Additional auxiliary sensors 122 may include an MMG sensor, a force sensor and/or a speaker/microphone”, [0029]).
Regarding Claim 5, Lee discloses the system of claim 4, wherein the first plurality of sensors and the second plurality of sensors further include, respectively:
a first echocardiogram (ECG) sensor and a second ECG sensor;
a first carbon dioxide sensor and a second carbon dioxide sensor; or
a first blood oxygen sensor and a second blood oxygen sensor (“ sensors 114-122 are capable of selectively detecting…blood oxygen level”, [0034]).
Regarding Claim 6, Lee discloses the system of claim 1, wherein the processing unit comprises part of a computing device that is separate from and communicatively connected to the first patient-wearable device and the second patient-wearable device (See Fig. 6; “each universal multimodality sensor module 102 may communicate with each other universal multimodality sensor module 102 and/or a computing device 130, such as without limitation thereto, a mobile computing device (e.g., a smartphone, smartwatch or tablet computer) or a desktop computer (e.g., a personal computer (PC)”, [0030]).
Regarding Claim 7, Lee discloses the system of claim 1, wherein the processing unit comprises part of the first patient-wearable device (See element 124, Fig. 4, which is part of the universal multimodality sensor module).
Regarding Claim 9, Lee discloses the system of claim 1, wherein the processing unit is configured to selectively turn on all sensors of a first type in the first plurality of sensors and turn off all sensors of the first type in the second plurality of sensors (“By way of example, receiver unit 104c located at the chest of wearer 106 may power ECG sensor 118 while leaving oximeter 114 unpowered. Conversely, receiver unit 104k located proximate the knee of wearer 106 may power speaker/microphone 122 while leaving unpowered ECG sensor 118”, [0032]).
Regarding Claim 11, Lee discloses a method performed by a processing unit (Element 130, Fig. 6), comprising:
establishing communication with a first patient-wearable device (Any element 102, Fig. 1; “each universal multimodality sensor module 102 may communicate with each other universal multimodality sensor module 102 and/or a computing device 130”, [0030]) that is attached to a first body location of a patient (“a) providing a plurality of receiver units wherein each receiver unit is configured to be secured at a selected location on a wearer's body; b) mounting a universal multimodality sensor module comprising a power source, a printed circuit board including a processor, memory and communication module, and a plurality of individual sensors to each respective receiver unit”, [0011]) and configured to detect a pulse condition at the first body location (“each universal multimodality sensor module comprises…a pulse oximeter”, [0012]), the first patient-wearable device comprising a first plurality of sensors (See Fig. 4; element 102 comprises a plurality of sensors);
establishing communication with a second patient-wearable device (Any element 102 not considered the first patient-wearable device, Fig. 1; “each universal multimodality sensor module 102 may communicate with each other universal multimodality sensor module 102 and/or a computing device 130”, [0030]) that is attached to a second body location of the patient (“a) providing a plurality of receiver units wherein each receiver unit is configured to be secured at a selected location on a wearer's body; b) mounting a universal multimodality sensor module comprising a power source, a printed circuit board including a processor, memory and communication module, and a plurality of individual sensors to each respective receiver unit”, [0011]) and configured to detect a pulse condition at the second body location (“each universal multimodality sensor module comprises…a pulse oximeter”, [0012]), the second patient-wearable device comprising a second plurality of sensors (See Fig. 4; element 102 comprises a plurality of sensors);
obtaining, from the first patient-wearable device, first information (“computing device 130 may include a software application configured to selectively communicate with each individual universal multimodality sensor module 102. Wearer 106 (or a physician) may utilize the application to instruct each universal multimodality sensor module 102 which sensors 114-122 are to be powered and unpowered”, [0032]) that specifies the first body location to which the first patient-wearable device is attached (“leads 132 may also engage contacts within receiver units 104. In accordance with an aspect of the present invention, the contacts within receiver units 104 may be selectively differentiated so that receiver units with specific contacts may be located at specified locations on wearer 106. When universal multimodality sensor module 102 is coupled to a receiver unit 104, leads 132 may interpret the specific contacts whereby processor 124 may selectively control which sensors 114-122 are powered by battery 110 to receive health data from the wearer”, [0032]) and which sensor types are included in the first plurality of sensors (“computing device 130 may include a software application configured to selectively communicate with each individual universal multimodality sensor module 102”, [0032]; receiving information from a module 102 implicitly comprises information about which sensor types are included in the plurality of sensors—namely, the sensor types of a first universal multimodality sensor module 102);
obtaining, from the second patient-wearable device, second information (“computing device 130 may include a software application configured to selectively communicate with each individual universal multimodality sensor module 102. Wearer 106 (or a physician) may utilize the application to instruct each universal multimodality sensor module 102 which sensors 114-122 are to be powered and unpowered”, [0032]) that specifies the second body location to which the second patient-wearable device is attached (“leads 132 may also engage contacts within receiver units 104. In accordance with an aspect of the present invention, the contacts within receiver units 104 may be selectively differentiated so that receiver units with specific contacts may be located at specified locations on wearer 106. When universal multimodality sensor module 102 is coupled to a receiver unit 104, leads 132 may interpret the specific contacts whereby processor 124 may selectively control which sensors 114-122 are powered by battery 110 to receive health data from the wearer”, [0032]) and which sensor types are included in the second plurality of sensors (“computing device 130 may include a software application configured to selectively communicate with each individual universal multimodality sensor module 102”, [0032]; receiving information from a module 102 implicitly comprises information about which sensor types are included in the plurality of sensors—namely, the sensor types of a second universal multimodality sensor module 102); and
communicating control signals to the first patient-wearable device and the second patient- wearable device to selectively turn on and off individual ones of the sensors in the first plurality of sensors and the second plurality of sensors based on at least the first information and the second information (“computing device 130 may include a software application configured to selectively communicate with each individual universal multimodality sensor module 102. Wearer 106 (or a physician) may utilize the application to instruct each universal multimodality sensor module 102 which sensors 114-122 are to be powered and unpowered”, [0032]).
Regarding Claim 13, Lee discloses the method of claim 11, wherein:
the first plurality of sensors and the second plurality of sensors include a same variety of sensor types (“each universal multimodality sensor module comprises a 9-axis accelerometer, a pulse oximeter, an electromyography (EMG) sensor and a mechanomyography (MMG) sensor”, [0012]).
Regarding Claim 14, Lee discloses the method of claim 13, wherein:
the first plurality of sensors includes at least a first inertial measurement unit (IMU) (“each universal multimodality sensor module comprises a 9-axis accelerometer, a pulse oximeter, an electromyography (EMG) sensor and a mechanomyography (MMG) sensor”, [0012]) and a first acoustic sensor (See element 122 in element 102, Fig. 4; “Additional auxiliary sensors 122 may include an MMG sensor, a force sensor and/or a speaker/microphone”, [0029]); and
the second plurality of sensors includes at least a second IMU (“each universal multimodality sensor module comprises a 9-axis accelerometer, a pulse oximeter, an electromyography (EMG) sensor and a mechanomyography (MMG) sensor”, [0012]) and a second acoustic sensor (See element 122 in element 102, Fig. 4; “Additional auxiliary sensors 122 may include an MMG sensor, a force sensor and/or a speaker/microphone”, [0029]).
Regarding Claim 15, Lee discloses the method of claim 14, wherein the first plurality of sensors and the second plurality of sensors further include, respectively:
a first echocardiogram (ECG) sensor and a second ECG sensor;
a first carbon dioxide sensor and a second carbon dioxide sensor; or
a first blood oxygen sensor and a second blood oxygen sensor (“ sensors 114-122 are capable of selectively detecting…blood oxygen level”, [0034]).
Regarding Claim 16, Lee discloses the method of claim 11, wherein the processing unit comprises part of a computing device that is separate from and communicatively connected to the first patient-wearable device and the second patient-wearable device (See Fig. 6; “each universal multimodality sensor module 102 may communicate with each other universal multimodality sensor module 102 and/or a computing device 130, such as without limitation thereto, a mobile computing device (e.g., a smartphone, smartwatch or tablet computer) or a desktop computer (e.g., a personal computer (PC)”, [0030]).
Regarding Claim 17, Lee discloses the method of claim 11, wherein the processing unit comprises part of the first patient-wearable device (See element 124, Fig. 4, which is part of the universal multimodality sensor module).
Regarding Claim 19, Lee discloses the method of claim 11, wherein selectively turning on and off the individual ones of the sensors in the first plurality of sensors and the second plurality of sensors comprises:
selectively turning on all sensors of a first type in the first plurality of sensors and turning off all sensors of the first type in the second plurality of sensors (“By way of example, receiver unit 104c located at the chest of wearer 106 may power ECG sensor 118 while leaving oximeter 114 unpowered. Conversely, receiver unit 104k located proximate the knee of wearer 106 may power speaker/microphone 122 while leaving unpowered ECG sensor 118”, [0032]).
Regarding Claim 21, Lee discloses a computer-readable medium (“a computing device including a computer processor and a computer memory”, [0011]) having instructions stored thereon that (“computing device 130 may include a software application configured to selectively communicate with each individual universal multimodality sensor module 102”, [0032]), when executed by a processing unit (“The processor unit within computing device 130”, [0034]), cause the processing unit to perform operations comprising:
establishing communication with a first patient-wearable device (Any element 102, Fig. 1; “each universal multimodality sensor module 102 may communicate with each other universal multimodality sensor module 102 and/or a computing device 130”, [0030]) that is attached to a first body location of a patient (“a) providing a plurality of receiver units wherein each receiver unit is configured to be secured at a selected location on a wearer's body; b) mounting a universal multimodality sensor module comprising a power source, a printed circuit board including a processor, memory and communication module, and a plurality of individual sensors to each respective receiver unit”, [0011]) and configured to detect a pulse condition at the first body location (“each universal multimodality sensor module comprises…a pulse oximeter”, [0012]), the first patient-wearable device comprising a first plurality of sensors (See Fig. 4; element 102 comprises a plurality of sensors);
establishing communication with a second patient-wearable device (Any element 102 not considered the first patient-wearable device, Fig. 1; “each universal multimodality sensor module 102 may communicate with each other universal multimodality sensor module 102 and/or a computing device 130”, [0030]) that is attached to a second body location of the patient (“a) providing a plurality of receiver units wherein each receiver unit is configured to be secured at a selected location on a wearer's body; b) mounting a universal multimodality sensor module comprising a power source, a printed circuit board including a processor, memory and communication module, and a plurality of individual sensors to each respective receiver unit”, [0011]) and configured to detect a pulse condition at the second body location (“each universal multimodality sensor module comprises…a pulse oximeter”, [0012]), the second patient-wearable device comprising a second plurality of sensors (See Fig. 4; element 102 comprises a plurality of sensors);
obtaining, from the first patient-wearable device, first information (“computing device 130 may include a software application configured to selectively communicate with each individual universal multimodality sensor module 102. Wearer 106 (or a physician) may utilize the application to instruct each universal multimodality sensor module 102 which sensors 114-122 are to be powered and unpowered”, [0032]) that specifies the first body location to which the first patient-wearable device is attached (“leads 132 may also engage contacts within receiver units 104. In accordance with an aspect of the present invention, the contacts within receiver units 104 may be selectively differentiated so that receiver units with specific contacts may be located at specified locations on wearer 106. When universal multimodality sensor module 102 is coupled to a receiver unit 104, leads 132 may interpret the specific contacts whereby processor 124 may selectively control which sensors 114-122 are powered by battery 110 to receive health data from the wearer”, [0032]) and which sensor types are included in the first plurality of sensors (“computing device 130 may include a software application configured to selectively communicate with each individual universal multimodality sensor module 102”, [0032]; receiving information from a module 102 implicitly comprises information about which sensor types are included in the plurality of sensors—namely, the sensor types of a first universal multimodality sensor module 102); and
obtaining, from the second patient-wearable device, second information (“computing device 130 may include a software application configured to selectively communicate with each individual universal multimodality sensor module 102. Wearer 106 (or a physician) may utilize the application to instruct each universal multimodality sensor module 102 which sensors 114-122 are to be powered and unpowered”, [0032]) that specifies the second body location to which the second patient-wearable device is attached (“leads 132 may also engage contacts within receiver units 104. In accordance with an aspect of the present invention, the contacts within receiver units 104 may be selectively differentiated so that receiver units with specific contacts may be located at specified locations on wearer 106. When universal multimodality sensor module 102 is coupled to a receiver unit 104, leads 132 may interpret the specific contacts whereby processor 124 may selectively control which sensors 114-122 are powered by battery 110 to receive health data from the wearer”, [0032]) and which sensor types are included in the second plurality of sensors (“computing device 130 may include a software application configured to selectively communicate with each individual universal multimodality sensor module 102”, [0032]; receiving information from a module 102 implicitly comprises information about which sensor types are included in the plurality of sensors—namely, the sensor types of a second universal multimodality sensor module 102); and
communicating control signals to the first patient-wearable device and the second patient- wearable device to selectively turn on and off individual ones of the sensors in the first plurality of sensors and the second plurality of sensors based on at least the first information and the second information (“computing device 130 may include a software application configured to selectively communicate with each individual universal multimodality sensor module 102. Wearer 106 (or a physician) may utilize the application to instruct each universal multimodality sensor module 102 which sensors 114-122 are to be powered and unpowered”, [0032]).
Regarding Claim 23, Lee discloses the computer-readable medium of claim 21, wherein:
the first plurality of sensors and the second plurality of sensors include a same variety of sensor types (“each universal multimodality sensor module comprises a 9-axis accelerometer, a pulse oximeter, an electromyography (EMG) sensor and a mechanomyography (MMG) sensor”, [0012]).
Regarding Claim 24, Lee discloses the computer-readable medium of claim 23, wherein:
the first plurality of sensors includes at least a first inertial measurement unit (IMU) (“each universal multimodality sensor module comprises a 9-axis accelerometer, a pulse oximeter, an electromyography (EMG) sensor and a mechanomyography (MMG) sensor”, [0012]) and a first acoustic sensor (See element 122 in element 102, Fig. 4; “Additional auxiliary sensors 122 may include an MMG sensor, a force sensor and/or a speaker/microphone”, [0029]); and
the second plurality of sensors includes at least a second IMU (“each universal multimodality sensor module comprises a 9-axis accelerometer, a pulse oximeter, an electromyography (EMG) sensor and a mechanomyography (MMG) sensor”, [0012]) and a second acoustic sensor (See element 122 in element 102, Fig. 4; “Additional auxiliary sensors 122 may include an MMG sensor, a force sensor and/or a speaker/microphone”, [0029]).
Regarding Claim 25, Lee discloses the computer-readable medium of claim 24, wherein the first plurality of sensors and the second plurality of sensors further include, respectively:
a first echocardiogram (ECG) sensor and a second ECG sensor;
a first carbon dioxide sensor and a second carbon dioxide sensor; or
a first blood oxygen sensor and a second blood oxygen sensor (“ sensors 114-122 are capable of selectively detecting…blood oxygen level”, [0034]).
Regarding Claim 26, Lee discloses the computer-readable medium of claim 21, wherein the processing unit comprises part of a computing device that is separate from and communicatively connected to the first patient-wearable device and the second patient-wearable device (See Fig. 6; “each universal multimodality sensor module 102 may communicate with each other universal multimodality sensor module 102 and/or a computing device 130, such as without limitation thereto, a mobile computing device (e.g., a smartphone, smartwatch or tablet computer) or a desktop computer (e.g., a personal computer (PC)”, [0030]).
Regarding Claim 27, Lee discloses the computer-readable medium of claim 21, wherein the processing unit comprises part of the first patient-wearable device (See element 124, Fig. 4, which is part of the universal multimodality sensor module).
Regarding Claim 29, Lee discloses the computer-readable medium of claim 21, wherein selectively turning on and off the individual ones of the sensors in the first plurality of sensors and the second plurality of sensors comprises:
selectively turning on all sensors of a first type in the first plurality of sensors and turning off all sensors of the first type in the second plurality of sensors (“By way of example, receiver unit 104c located at the chest of wearer 106 may power ECG sensor 118 while leaving oximeter 114 unpowered. Conversely, receiver unit 104k located proximate the knee of wearer 106 may power speaker/microphone 122 while leaving unpowered ECG sensor 118”, [0032]).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 2, 12, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Lee in view of Andre et al (US 20120245439 A1, hereinafter Andre).
Regarding Claim 2, Lee discloses the system of claim 1. Lee discloses the claimed invention except for expressly disclosing wherein at least one of the first patient-wearable device and the second patient-wearable device is configured to detect a subpulse condition at the respective body location. However, Andre, which also discloses a patient-wearable device (Element 400, Fig. 4; [0029]), teaches wherein the patient-wearable device is configured to detect a subpulse condition (“the device and method of the present invention utilizes development of mathematic formulas and/or algorithms to determine the presence of a critical care parameter. As used herein, a critical care parameter is one that indicates the existence of a critical illness or injury. Such illnesses or injury can include, but are not limited to… 1) non-traumatic hemorrhage 2) traumatic hemorrhage; 3) acute and chronic heart failure including myocardial infarction and acute arhythmias; 4) cardiac arrest and cardiogenic shock”, [0085]; traumatic hemorrhages correspond to traumatic blood loss and drops in blood pressure, which corresponds to the applicant’s definition of a subpulse condition in [0004] of the instant specification) at the respective body location (“The time of the arrival of the corresponding pressure wave at a given location on the body can be measured using any one of a number of pressure sensors. Such pressure sensors may include, but are not limited to, pulse oximeters, Doppler arrays, single piezoelectric sensors, acoustic piezoelectric sensors, fiber optic acoustic sensors, blood volume pressure or BVP sensors, optical plethysmographic sensors, micropower impulse radar detectors, and seismophones.”, [0177]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Lee to detect subpulse conditions, as taught by Andre, for the advantage of detecting a critical illness or injury, as suggested by Andre ([0085]).
Regarding Claim 12, Lee discloses the method of claim 11. Lee discloses the claimed invention except for expressly disclosing wherein at least one of the first patient-wearable device and the second patient-wearable device is configured to detect a subpulse condition at the respective body location. However, Andre, which also discloses a patient-wearable device (Element 400, Fig. 4; [0029]), teaches wherein the patient-wearable device is configured to detect a subpulse condition (“the device and method of the present invention utilizes development of mathematic formulas and/or algorithms to determine the presence of a critical care parameter. As used herein, a critical care parameter is one that indicates the existence of a critical illness or injury. Such illnesses or injury can include, but are not limited to… 1) non-traumatic hemorrhage 2) traumatic hemorrhage; 3) acute and chronic heart failure including myocardial infarction and acute arhythmias; 4) cardiac arrest and cardiogenic shock”, [0085]; traumatic hemorrhages correspond to traumatic blood loss and drops in blood pressure, which corresponds to the applicant’s definition of a subpulse condition in [0004] of the instant specification) at the respective body location (“The time of the arrival of the corresponding pressure wave at a given location on the body can be measured using any one of a number of pressure sensors. Such pressure sensors may include, but are not limited to, pulse oximeters, Doppler arrays, single piezoelectric sensors, acoustic piezoelectric sensors, fiber optic acoustic sensors, blood volume pressure or BVP sensors, optical plethysmographic sensors, micropower impulse radar detectors, and seismophones.”, [0177]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Lee wherein at least one of the first patient-wearable device and the second patient-wearable device detects subpulse conditions, as taught by Andre, for the advantage of detecting a critical illness or injury, as suggested by Andre ([0085]).
Regarding Claim 22, Lee discloses the computer-readable medium of claim 21. Lee discloses the claimed invention except for expressly disclosing wherein at least one of the first patient-wearable device and the second patient-wearable device is configured to detect a subpulse condition at the respective body location. However, Andre, which also discloses a patient-wearable device (Element 400, Fig. 4; [0029]), teaches wherein the patient-wearable device is configured to detect a subpulse condition (“the device and method of the present invention utilizes development of mathematic formulas and/or algorithms to determine the presence of a critical care parameter. As used herein, a critical care parameter is one that indicates the existence of a critical illness or injury. Such illnesses or injury can include, but are not limited to… 1) non-traumatic hemorrhage 2) traumatic hemorrhage; 3) acute and chronic heart failure including myocardial infarction and acute arhythmias; 4) cardiac arrest and cardiogenic shock”, [0085]; traumatic hemorrhages correspond to traumatic blood loss and drops in blood pressure, which corresponds to the applicant’s definition of a subpulse condition in [0004] of the instant specification) at the respective body location (“The time of the arrival of the corresponding pressure wave at a given location on the body can be measured using any one of a number of pressure sensors. Such pressure sensors may include, but are not limited to, pulse oximeters, Doppler arrays, single piezoelectric sensors, acoustic piezoelectric sensors, fiber optic acoustic sensors, blood volume pressure or BVP sensors, optical plethysmographic sensors, micropower impulse radar detectors, and seismophones.”, [0177]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the operations of Lee such that at least one of the first patient-wearable device and the second patient-wearable device detects subpulse conditions, as taught by Andre, for the advantage of detecting a critical illness or injury, as suggested by Andre ([0085]).
Claims 8, 18, and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Lee in view of McKenna et al (US 20110213217 A1, hereinafter McKenna).
Regarding Claim 8, Lee discloses the system of claim 1. Lee discloses the claimed invention except for expressly disclosing wherein the processing unit is further configured to selectively turn on and off the individual ones of the sensors in the first plurality of sensors and the second plurality of sensors based on one or more of:
one or more factors associated with an environment of the patient; or a type of medical procedure.
However, McKenna, which also teaches wherein the processing unit is configured to selectively turn on and off the individual ones of the sensors (“The subset of subsensors that have been flagged as active and the sensing functions that will be used is known as a "data collection modality”, [0027]), teaches wherein the processing unit is configured to selectively turn on and off the individual ones of the sensors (Step 92, Fig. 3; “Such discrete data may then be evaluated with respect to certain update factors 92 of FIG. 4 and used to determine (block 86) or update the data collection modality”, [0029]) based on one or more of:
one or more factors associated with an environment of the patient (“A sixth example of an update factor 92 may be the current location 104 of the patient…For example, if the patient is currently located in a medical facility room…”, [0044]; an interior of a medical facility is also associated with the indoor environment of the patient); or a type of medical procedure (“For example, it may be desirable that the wireless sensor 14 generate different types or amounts of patient data depending on whether the patient 34 is in surgery…Thus, the current location of the patient may be considered as one of the update factors 92.”, [0044]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Lee with the teachings of McKenna for the advantages of conserving power as taught by McKenna (“To conserve the amount of power used by the wireless sensor 14, the microprocessor 38 may set the data collection modality, the data collection rate for each one of the subsensors in the data collection modality”, [0026]; [0044]).
Regarding Claim 18, Lee discloses the method of claim 11. Lee discloses the claimed invention except for expressly disclosing wherein selectively turning on and off the individual ones of the sensors in the first plurality of sensors and the second plurality of sensors based on at least the first information and the second information further comprises selectively turning on and off the individual ones of the sensors in the first plurality of sensors and the second plurality of sensors based on one or more of:
one or more factors associated with an environment of the patient; or
a type of medical procedure.
However, McKenna, which also teaches selectively turning on and off the individual ones of the sensors (“The subset of subsensors that have been flagged as active and the sensing functions that will be used is known as a "data collection modality”, [0027]), teaches selectively turning on and off the individual ones of the sensors (Step 92, Fig. 3; “Such discrete data may then be evaluated with respect to certain update factors 92 of FIG. 4 and used to determine (block 86) or update the data collection modality”, [0029]) based on one or more factors associated with an environment of the patient (“A sixth example of an update factor 92 may be the current location 104 of the patient…For example, if the patient is currently located in a medical facility room…”, [0044]; an interior of a medical facility is also associated with the indoor environment of the patient); or a type of medical procedure (“For example, it may be desirable that the wireless sensor 14 generate different types or amounts of patient data depending on whether the patient 34 is in surgery…Thus, the current location of the patient may be considered as one of the update factors 92”, [0044]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Lee with the teachings of McKenna, such that selectively turning on and off the individual ones of the sensors in the first plurality of sensors and the second plurality of sensors based on at least the first information and the second information further comprises selectively turning on and off the individual ones of the sensors in the first plurality of sensors and the second plurality of sensors based on one or more of: one or more factors associated with an environment of the patient; or a type of medical procedure, for the advantages of conserving power as taught by McKenna (“To conserve the amount of power used by the wireless sensor 14, the microprocessor 38 may set the data collection modality, the data collection rate for each one of the subsensors in the data collection modality”, [0026]; [0044]).
Regarding Claim 28, Lee discloses the computer-readable medium of claim 21. Lee discloses the claimed invention except for expressly disclosing wherein selectively turning on and off the individual ones of the sensors in the first plurality of sensors and the second plurality of sensors based on at least the first information and the second information further comprises selectively turning on and off the individual ones of the sensors in the first plurality of sensors and the second plurality of sensors based on one or more of:
one or more factors associated with an environment of the patient; or
a type of medical procedure.
However, McKenna, which also teaches selectively turning on and off the individual ones of the sensors (“The subset of subsensors that have been flagged as active and the sensing functions that will be used is known as a "data collection modality”, [0027]), teaches selectively turning on and off the individual ones of the sensors (Step 92, Fig. 3; “Such discrete data may then be evaluated with respect to certain update factors 92 of FIG. 4 and used to determine (block 86) or update the data collection modality.”, [0029]) based on one or more factors associated with an environment of the patient (“A sixth example of an update factor 92 may be the current location 104 of the patient…For example, if the patient is currently located in a medical facility room…”, [0044]; an interior of a medical facility is also associated with the indoor environment of the patient); or a type of medical procedure (“For example, it may be desirable that the wireless sensor 14 generate different types or amounts of patient data depending on whether the patient 34 is in surgery…Thus, the current location of the patient may be considered as one of the update factors 92.”, [0044]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Lee with the teachings of McKenna, such that selectively turning on and off the individual ones of the sensors in the first plurality of sensors and the second plurality of sensors based on at least the first information and the second information further comprises selectively turning on and off the individual ones of the sensors in the first plurality of sensors and the second plurality of sensors based on one or more of: one or more factors associated with an environment of the patient; or a type of medical procedure, for the advantages of conserving power as taught by McKenna (“To conserve the amount of power used by the wireless sensor 14, the microprocessor 38 may set the data collection modality, the data collection rate for each one of the subsensors in the data collection modality”, [0026]; [0044]).
Claims 10, 20, and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Lee in view of Venkatraman et al (US 20220054008 A1, hereinafter Venkatraman).
Regarding Claim 10, Lee discloses the system of claim 1. Lee discloses the claimed invention except for expressly disclosing wherein the processing unit is configured to selectively turn on all sensors of a first type in the first plurality of sensors and the second plurality of sensors and to turn off all sensors of a second type in the first plurality of sensors and the second plurality of sensors. However, Venkatraman, which is also directed towards a first and second patient-wearable device (“The biological sensor data may be acquired by multiple sensors, which may be located on a single device or on multiple devices”, [0026]; “The monitoring device 102 may be a specially designed device for sensing a certain type or types of patient data via placement on a patient's body…”, [0033]), teaches wherein the processing unit (Element 112, Fig. 2A; in the alternative, element 142, Fig. 2A) is configured to selectively turn on all sensors of a first type (“Thus, the remote clinician may request via communication link with the transmitting device (which may be either central server based connection or peer-to-peer connection) that the transmitting device may selectively transmit a subset of biological sensor data, which is lung sounds in this example”, [0127] – the sensors for generating the subset of biological sensor data associated with the lung sounds is considered “all sensors of a first type” as claimed) in the first plurality of sensors and the second plurality of sensors (“The biological sensor data may be acquired by multiple sensors, which may be located on a single device or on multiple devices”, [0026]) and to turn off all sensors of a second type (“Responsive to the selective transmission request from the receiving device, the transmitting device may initiate another request from the transmitting device to power off corresponding monitoring devices that do not generate the selected biological sensor data…the transmitting device may automatically generate a second request to terminate connection with the PPG sensor while maintaining wireless communication with the monitoring device acquiring the lung sounds”, [0127]) in the first plurality of sensors and the second plurality of sensors (“The biological sensor data may be acquired by multiple sensors, which may be located on a single device or on multiple devices”, [0026]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Lee, with the teachings of Venkatraman, for the advantage of receiving sensor data that is more relevant to the patient’s condition, as taught by Venkatraman ([0127]).
Regarding Claim 20, Lee discloses the method of claim 11. Lee discloses the claimed invention except for expressly disclosing wherein selectively turning on and off the individual ones of the sensors in the first plurality of sensors and the second plurality of sensors comprises:
selectively turning on all sensors of a first type in the first plurality of sensors and the second plurality of sensors and turning off all sensors of a second type in the first plurality of sensors and the second plurality of sensors.
However, Venkatraman teaches wherein selectively turning on and off the individual ones of the sensors in the first plurality of sensors and the second plurality of sensors comprises:
selectively turning on all sensors of a first type (“Thus, the remote clinician may request via communication link with the transmitting device (which may be either central server based connection or peer-to-peer connection) that the transmitting device may selectively transmit a subset of biological sensor data, which is lung sounds in this example”, [0127] – the sensors for generating the subset of biological sensor data associated with the lung sounds is considered “all sensors of a first type” as claimed) in the first plurality of sensors and the second plurality of sensors (“The biological sensor data may be acquired by multiple sensors, which may be located on a single device or on multiple devices”, [0026]) and turning off all sensors of a second type (“Responsive to the selective transmission request from the receiving device, the transmitting device may initiate another request from the transmitting device to power off corresponding monitoring devices that do not generate the selected biological sensor data…the transmitting device may automatically generate a second request to terminate connection with the PPG sensor while maintaining wireless communication with the monitoring device acquiring the lung sounds”, [0127]) in the first plurality of sensors and the second plurality of sensors (“The biological sensor data may be acquired by multiple sensors, which may be located on a single device or on multiple devices”, [0026]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Lee, with the teachings of Venkatraman, for the advantage of receiving sensor data that is more relevant to the patient’s condition, as taught by Venkatraman ([0127]).
Regarding Claim 30, Lee discloses the computer-readable medium of claim 21. Lee discloses the claimed invention except for expressly disclosing wherein selectively turning on and off the individual ones of the sensors in the first plurality of sensors and the second plurality of sensors comprises:
selectively turning on all sensors of a first type in the first plurality of sensors and the second plurality of sensors and turning off all sensors of a second type in the first plurality of sensors and the second plurality of sensors.
However, Venkatraman discloses wherein selectively turning on and off the individual ones of the sensors in the first plurality of sensors and the second plurality of sensors comprises:
selectively turning on all sensors of a first type (“Thus, the remote clinician may request via communication link with the transmitting device (which may be either central server based connection or peer-to-peer connection) that the transmitting device may selectively transmit a subset of biological sensor data, which is lung sounds in this example”, [0127] – the sensors for generating the subset of biological sensor data associated with the lung sounds is considered “all sensors of a first type” as claimed) in the first plurality of sensors and the second plurality of sensors (“The biological sensor data may be acquired by multiple sensors, which may be located on a single device or on multiple devices”, [0026]) and turning off all sensors of a second type (“Responsive to the selective transmission request from the receiving device, the transmitting device may initiate another request from the transmitting device to power off corresponding monitoring devices that do not generate the selected biological sensor data…the transmitting device may automatically generate a second request to terminate connection with the PPG sensor while maintaining wireless communication with the monitoring device acquiring the lung sounds”, [0127]) in the first plurality of sensors and the second plurality of sensors (“The biological sensor data may be acquired by multiple sensors, which may be located on a single device or on multiple devices”, [0026]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the instructions of Lee, with the teachings of Venkatraman, for the advantage of receiving sensor data that is more relevant to the patient’s condition, as taught by Venkatraman ([0127]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
See Chiu (US 9364182 B2).
See Rodgers et al (US 20210361165 A1).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONATHAN EPHRAIM COOPER whose telephone number is (571)272-2860. The examiner can normally be reached Monday-Friday 7:30AM-5:30PM EST.
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/JONATHAN E. COOPER/Examiner, Art Unit 3791
/JACQUELINE CHENG/Supervisory Patent Examiner, Art Unit 3791