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 .
References to the instant application’s as-filed specification has been made using the USPGPub. version of the specification in this Office action.
Claim Objections
Claim 3 is objected to because of the following informalities: the word "wherein" that normally proceeds further limitations is missing from claim 3. Suggested correction "The method of claim 1, wherein the camera...". Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 10 and 11 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 10, which is directed to a method, recites the limitation of “the method further comprises an on-body sensor”. Therefore, claim 10 is reciting both method and product. MPEP 2173.05(p)(II) states that “A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. See In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303, 1318, 97 USPQ2d 1737, 1748-49 (Fed. Cir. 2011).”
The term “substantially” in claim 11 is a relative term which renders the claim indefinite. The term “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The “real time” parameter is rendered indefinite by the use of the relative term “substantially.”
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Statutory Category
Claims 1-20 recite a method and is therefore a process.
Step 2A—Prong 1: Recited Judicial Exception
Claim 1 recites the following limitations:
receiving temperature data from a continuous temperature monitor worn by a patient
receiving at least one vital sign data from a rPPG device
inputting the received temperature data and the at least one vital sign data to a remote server-side computer system
analyze the received temperature data and the at least one vital sign data for indication of a fever during the collection time period
transmit a notification of a result of the analysis to a personal device of the patient and/or to a clinician
The limitations, as drafted, describe a process that, under its broadest reasonable interpretation, includes performance of the limitation in the mind except for the recitation of a flexible patch comprising a temperature sensor, a rPPG device configured to conduct a remote photoplethysmogram, a remote server-side computer system, and a personal device.
The steps of “receiving signals” from a flexible patch comprising a temperature sensor and a rPPG device configured to conduct a remote photoplethysmogram are not being performed by the temperature sensor and the rPPG device, they are only associated with the type of data being received. The limitation of a personal device, which is nothing more than a generic computer (see [0030] of the specification) likewise does not carry out the limitation of “transmit a notification.”. The server-side computer is nothing more than a generic computer system, and other than being performed by a computer, nothing in the claim precludes the steps from practically being performed in the human mind or being considered as methods of organizing human activity.
MPEP 2106.04(a)(2)(II) states that the sub-grouping "managing personal behavior or relationships or interactions between people" include social activities, teaching, and following rules or instructions and MPEP 2106.04(a)(2)(III) states that “the courts consider a mental process (thinking) that "can be performed in the human mind, or by a human using a pen and paper" to be an abstract idea.” For example, aside from the recitations of “a server-side computer” language, the claim encompasses the medical professional in computing and evaluating temperature and heart-related parameters to determine whether or not patient has a fever (mental process) and communicating the determined condition to another medical professional and/or the patient (organizing human activity).
Step 2A—Prong 2: Integration into a Practical Application
While “a flexible patch comprising a temperature sensor”, “a rPPG device configured to conduct a remote photoplethysmogram”, and “a personal device” are not performing any recited steps, these limitations have been given full consideration under Step 2A, Prong 2 and Step 2B for the purpose of compact prosecution. The additional elements, “a flexible patch comprising a temperature sensor and a rPPG device configured to conduct a remote photoplethysmogram”, are nothing more than the source of the signal received by the system and amount to mere pre-solution data gathering and a personal device to which a signal is sent and amounts to mere post-solution activity of displaying information. The claim recites a server-side computer to perform the abstract steps. This limitation read on a computer implemented system and method and are recited at a high level of generality, i.e., as a generic processor, performing a generic computer function of processing data. This generic processor limitation is no more than mere instructions to apply the exception using a generic computer component. Accordingly, this additional limitation does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea.
Step 2B: Inventive Concept
As discussed with respect to Step 2A Prong Two, the additional elements in the claim amount to no more than pre-solution activity, post-solution activity, or mere instructions to apply the exception using a generic computer component. The same analysis applies here in 2B, i.e., mere instructions to apply an exception on a generic computer and extra-solution activity cannot integrate a judicial except into a practical application at Step 2A or provide an inventive concept in Step 2B.
Under 2019 PEG, a conclusion that an additional element is insignificant extra-solution activity in Step 2A should be re-evaluated in Step 2B to determine if it is more than what is well-understood, routine, conventional activity in the field. The specification in [0009]] does not provide any indication that the computer processor and memory of the server-side computer are anything other than generic, off-the-shelf computer components. Court decisions cited in MPEP 2106.05(d)(II) indicate that computer‐implemented processes not to be significantly more than an abstract idea (and thus ineligible) where the claim as a whole amounts to nothing more than generic computer functions merely used to implement an abstract idea, such as an idea that could be done by a human analog (i.e., by hand or by merely thinking). Accordingly, a conclusion that the generic computer functions merely being used to implement an abstract idea is well-understood, routine, conventional activity is supported under Berkheimer Option 2.
Regarding the rPPG device of claim 1, 3-4, 6-7, & 12. The use of a smartphone or wearable device as a PPG device comprising a wireless transmitter is well-understood, routine, and conventional activity as evidenced by WIPO document WO 2019198991 A1.
Regarding temperature sensor of claim 1 and 12 a flexible patch configured to be attached to the patient's skin comprising a temperature sensor a wireless transmitter is a is well-understood, routine, and conventional product as evidenced by the applicant’s own specification citing the body temperature logging patch described in any of U.S. Pat. Nos. 11,819,313; 10,849,501; 9,782,082; and/or 9,693,689 and commercially available TempTraq® brand temperature logging patch in [0021] of the specification.
Dependent claims 2-12 and 13-20 further limit the abstract idea already indicated in independent claim 1 and they are ineligible for the same reasons provided for claim 1 above.
For claim 13, the limitation that “the patient is undergoing or has undergone chimeric antigen receptor T-cell (CAR-T) therapy” is not a method step but further defines the patient population being evaluated. The limitation of “the fever is caused by cytokine release syndrome” is directed to a natural phenomenon of cytokine release syndrome causing fever in a patient. Therefore, claim 13 is ineligible for the same reasons provided for claim 1 above.
For these reasons, there is no inventive concept in the claim and thus it is ineligible.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-3, 6-7, 10-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 6, 7, 9, 16, & 17 of U.S. Patent No. 11819313 in view of Frank (US 2021/0275034).
With respect to instant claims 1-3, 6-7, 10-20
Instant Application18/971,654
Conflicting Patent
US 11819313 B2
Differences
Claim 1
A method comprising: receiving temperature data from a continuous temperature monitor worn by a patient, the continuous temperature monitor comprising a flexible patch configured to be attached to the patient's skin, the flexible patch comprising a temperature sensor that is configured to automatically collect at least one temperature of the patient every five minutes during a collection time period;
Claim 1
A method comprising: receiving temperature data from a continuous temperature monitor worn by a patient, the continuous temperature monitor comprising a flexible patch configured to be attached to the patient's skin, the flexible patch comprising a temperature sensor that is configured to automatically collect at least one temperature of the patient every five minutes during a collection time period;
receiving at least one vital sign data from a rPPG device configured to conduct a remote photoplethysmogram (rPPG) comprising a plethysmogram that is optically obtained by detection of blood volume changes in the microvascular bed of tissue of the patient via a non-contact and non-invasive transdermal optical imaging using a camera to measure and analyze variations in the light reflected off the patient’s skin;
receiving at least one vital sign data from a rPPG device configured to conduct a remote photoplethysmogram (rPPG) comprising a plethysmogram that is optically obtained by detection of blood volume changes in the microvascular bed of tissue of the patient via a non-contact and non-invasive transdermal optical imaging using a camera to measure and analyze variations in the light reflected off the patient’s skin;
inputting the received temperature data and the at least one vital sign data to a remote server-side computer system comprising at least a processor and database/memory,
inputting the received temperature data to a machine learning system, the machine learning system
and the at least one vital sign data
wherein the remote server-side computer system is configured to:
the machine learning system being trained to output a predictive temperature profile of the patient based upon the received temperature data,
analyze the received temperature data and the at least one vital sign data for indication of a fever during the collection time period;
analyzing the predictive temperature profile for an indication of a fever
and transmit a notification of a result of the analysis to a personal device of the patient and/or to a clinician, wherein the notification comprises an alert when the result of the analysis indicates the fever.
transmitting a notification of a result of the analysis to a personal device of the patient and/or to a clinician, wherein the notification comprises an alert when the result of the analysis indicates the fever
Claim 2
The method of claim 1, wherein the at least one vital sign data comprises at least one of the patient’s pulse or heart rate, heart rate variability, blood pressure, blood-oxygen levels, and/or respiratory rate.
The method of claim 1 (as above),
wherein the at least one vital sign data comprises at least one of the patient’s pulse or heart rate, heart rate variability, blood pressure, blood-oxygen levels, and/or respiratory rate.
Claim 3
The method of claim 1, the camera is part of the rPPG device comprising at least one of a smartphone, tablet, or other computer device.
The method of claim 1 (as above),
the camera is part of the rPPG device comprising at least one of a smartphone, tablet, or other computer device.
Claim 6
The method of claim 3, wherein the rPPG device is the personal device of the patient.
The method of claim 1 (as above),
The method of claim 3, wherein the rPPG device is the personal device of the patient.
Claim 7
The method of claim 3, wherein the rPPG device comprises a processor and non-transient memory that is configured to execute a computer program application to operate the camera and obtain the at least one vital sign data by conducting the remote photoplethysmogram using the camera.
The method of claim 1 (as above),
The method of claim 3, wherein the rPPG device comprises a processor and non-transient memory that is configured to execute a computer program application to operate the camera and obtain the at least one vital sign data by conducting the remote photoplethysmogram using the camera.
Claim 10
The method of claim 1, wherein the method further comprises an on-body sensor that is physically worn upon the patient’s body to conduct an auxiliary photoplethysmogram (PPG) scan.
The method of claim 1 (as above),
wherein the method further comprises an on-body sensor that is physically worn upon the patient’s body to conduct an auxiliary photoplethysmogram (PPG) scan.
Claim 11
The method of claim 1, wherein the notification from the remote server-side computer system is transmitted in substantially real time with the receipt of the temperature data, the at least one vital sign data, and result of the analysis.
Claim 1
The method of claim 1 (as above), and wherein the notification is transmitted in substantially real time with the receipt of the temperature data and result of the analysis.
the at least one vital sign data
Claim 12
The method of claim 1, wherein each of the flexible patch and the rPPG device comprise a wireless transmitter, and wherein the remote server-side computer system is remotely connected to the continuous temperature monitor, the rPPG device, and to the clinician via a network.
Claim 2
The method of claim 1 (as above), and wherein the flexible patch comprises a wireless transmitter, and wherein the machine learning system is remotely connected to the continuous temperature monitor and to the clinician via a network.
the rPPG device
Claim 13
The method of claim 1, wherein the patient is undergoing or has undergone chimeric antigen receptor T-cell (CAR-T) therapy, and the fever is caused by cytokine release syndrome.
Claim 16
The method of claim 1 (as above), and wherein the patient is undergoing or has undergone chimeric antigen receptor T-cell (CAR-T) therapy, and the fever is caused by cytokine release syndrome.
Claim 14
The method of claim 1, wherein analyzing the temperature data and the at least one vital sign data for indication of a fever comprises comparing the temperature data and the at least one vital sign data to respective predetermined thresholds.
Claim 6
The method of claim 1 (as above), and wherein analyzing the predictive temperature profile for the fever comprises comparing the predicted temperature values to a predetermined threshold.
and the at least one vital sign data
Claim 15
The method of claim 1, wherein analyzing the temperature data and the at least one vital sign data for indication of a fever comprises comparing a rate of increase of the temperature data and the at least one vital sign data to respective predetermined thresholds.
Claim 7
The method of claim 1 (as above, and wherein analyzing the predictive temperature profile for the fever comprises comparing a rate of increase of the predictive temperature profile to a predetermined threshold
and the at least one vital sign data
Claim 16
The method of claim 1, wherein the notification from the remote server-side computer system further comprises an instruction to the patient to seek medical attention when the result of the analysis indicates the fever.
Claim 9
The method of claim 1 (as above, and wherein the notification further comprises an instruction to the patient to seek medical attention when the result of the analysis indicates the fever.
Claim 17
The method of claim 1, wherein the remote server-side computer system further provides a visual clinician dashboard that displays the temperature data and at least one vital sign data from one or more patients upon a computer screen.
Claim 17
The method of claim 1 (as above, and the notification further comprises a time series graph of the predicted temperature values
and at least one vital sign data
Claim 18
The method of claim 17, wherein the temperature data and the at least one vital sign data are time-correlated on the visual clinician dashboard.
Claim 17
The method of claim 1 (as above, and at the plurality of corresponding times in the future time period.
and the at least one vital sign data
Claim 19
The method of claim 17, wherein the remote server-side computer system causes the visual clinician dashboard to display the temperature data and at least one vital sign data in substantially real time.
Claim 17
The method of claim 1 (as above and the notification is transmitted in substantially real time with the receipt of the temperature data and result of the analysis), and the notification further comprises a time series graph.
and the at least one vital sign data
Claim 20
The method of claim 17, wherein the visual clinician dashboard further displays the alert when the result of the analysis indicates the fever.
Claim 9
The method of claim 1 (as above, and the notification further comprises an instruction to the patient to seek medical attention when the result of the analysis indicates the fever
Claim 17
the notification further comprises a time series graph of the predicted temperature values
Therefore, claims in U.S. Patent No. 11819313 recites limitations of instant claims 1-3, 6-7, 10-20, except for
receiving at least one vital sign data from a rPPG device configured to conduct a remote photoplethysmogram (rPPG) comprising a plethysmogram that is optically obtained by detection of blood volume changes in the microvascular bed of tissue of the patient via a non-contact and non-invasive transdermal optical imaging using a camera to measure and analyze variations in the light reflected off the patient’s skin, and the at least one vital sign data;
wherein the at least one vital sign data comprises at least one of the patient’s pulse or heart rate, heart rate variability, blood pressure, blood-oxygen levels, and/or respiratory rate;
the camera is part of the rPPG device comprising at least one of a smartphone, tablet, or other computer device;
wherein the rPPG device is the personal device of the patient;
wherein the rPPG device comprises a processor and non-transient memory that is configured to execute a computer program application to operate the camera and obtain the at least one vital sign data by conducting the remote photoplethysmogram using the camera;
wherein the method further comprises an on-body sensor that is physically worn upon the patient’s body to conduct an auxiliary photoplethysmogram (PPG) scan.
However, attention is brought to the Frank reference with teaches a wearable-based system that can help determine whether a user is healthy, comprising, in one embodiment, a photoplethysmogram signal (PPG signal) (receiving at least one vital sign data from a rPPG device) and a temperature measurement (abstract). This system includes the use of wearable devices with sensors that measure physiological signals of their wearers. An example of such a wearable device are smartglasses with embedded sensors. For example, the smartglasses may include some of the following sensors: a photoplethysmogram (PPG) sensor that measures blood flow and blood oxygen saturation (the at least one vital sign data comprises at least one of the patient’s pulse or heart rate, blood-oxygen levels,) at a region on the face, a thermal sensor that measures temperature at region on the face, an acoustic sensor that takes audio recordings indicative of voice, respiration (and/or respiratory rate), and/or coughing, a movement sensor, and more ([0016]). The system uses these measurements taken by a wearable device worn by a user to calculate a health score, which may refer to an extent to which a user displays symptoms of a certain disease certain disease or refer to an extent to which a user is considered healthy according to general wellness considerations that involve one or more of the user's vital signs (e.g., whether the core body temperature is elevated, blood oxygen saturation is in a normal range, etc.) ([0017]).
Fig 14A illustrates one possible use of such a system and Frank discloses that device (802) is configured to measure first and second signals indicative of photoplethysmogram signals and that in one embodiment, device (802) is a video camera (the camera is part of the rPPG device) that is not head-mounted, such as a camera of a mobile phone, a camera of a laptop, and/or a webcam (comprising at least one of a smartphone, tablet, or other computer device) ([0399]-[0400]) and that essentially all functions attributed to the computer herein, such as capturing and analyzing PPG images, may be performed by a processor on a wearable device (e.g., smartglasses to which the head-mounted devices are coupled) and/or some other device carried by the user, such as a smartwatch or smartphone ([0418]) and functions attributed to the computer may be performed by a computer on a wearable device (e.g., smartglasses) and/or a computer of the user (e.g., smartphone) ([1022]) (wherein the rPPG device is the personal device of the patient). In other embodiments various devices such as the device (802) and/or the computer (800) may be physically coupled to the frame (810), which may belong to smartglasses or to a smart-helmet (an on-body sensor that is physically worn upon the patient’s body) ([0404]) and that at least some feature values may be generated based on additional PPG signals (to conduct an auxiliary photoplethysmogram (PPG) scan) acquired using additional PPG devices (in addition to the device (802)) ([0448]).
Frank further discloses that the steps outlined for the operation of the device as illustrated in Fig. 14A-C, including operating a PPG device, may be performed by a processor running a computer program having instructions for implementing the method. Optionally, the instructions may be stored on a computer-readable medium, which may optionally be a non-transitory computer-readable medium (a processor and non-transient memory that is configured to execute a computer program application to operate the camera and obtain the at least one vital sign data by conducting the remote photoplethysmogram using the camera) ([0458]) Frank further clarifies that “The embodiments are not limited in their applications to the order of steps of the methods, or to details of implementation of the devices, set in the description, drawings, or example” in [1040].
It would have been obvious to one of ordinary skill in the art at the time of filing of the instant application to utilize the photoplethysmogram device of the system taught by Frank to augment the method of US 11819313 for the purpose of help determining whether a user is healthy.
Claims 4 & 5 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11819313 in view of Frank as applied to claims 1 & 3 above, and further in view of Berry (US 2013/0141697).
With respect to instant claims 4 & 5
Claim 4
The method of claim 3, wherein the camera of the rPPG device is a front-facing camera that is arranged on the same side as a video display screen of the rPPG device that displays a live video feed of the patient’s face when the remote photoplethysmogram scan is conducted.
The method of claim 1 (as above),
The method of claim 3, wherein the camera of the rPPG device is a front-facing camera that is arranged on the same side as a video display screen of the rPPG device that displays a live video feed of the patient’s face when the remote photoplethysmogram scan is conducted.
Claim 5
The method of claim 4, wherein alignment indicia is overlaid onto the live video feed to assist the patient maintain their face within a predetermined target zone during the remote photoplethysmogram scan.
The method of claim 1 (as above),
The method of claim 4, wherein alignment indicia is overlaid onto the live video feed to assist the patient maintain their face within a predetermined target zone during the remote photoplethysmogram scan.
The claims of existing US 11819313 in view of Frank do not recite wherein the camera of the rPPG device is a front-facing camera that is arranged on the same side as a video display screen of the rPPG device that displays a live video feed of the patient’s face when the remote photoplethysmogram scan is conducted, nor do they recite wherein alignment indicia is overlaid onto the live video feed to assist the patient maintain their face within a predetermined target zone during the remote photoplethysmogram scan.
However, attention is brought to the Berry reference which teaches a systems, methods, and computer program products related to interactive medical testing and the diagnosis of medical conditions using portable consumer devices ([0003]). Self-testing and self-examination have become increasingly common alternatives to travel to a medical facility. However, these self-diagnosis tests, which are often designed and/or carried out without professional guidance or expert knowledge, are frequently fraught with inaccuracies resulting from a consumer performing the test incorrectly. To facilitate self-testing or self-examination in a manner that can eliminate much of the inaccuracy, Berry teaches an invention that can be used to help improve the foregoing state of medical testing, particularly self-testing, by providing rich, interactive medical testing environments through computing devices, such as portable consumer devices which are linked to professional systems ([0040-0042]).
In Fig. 3 and in [0069] Berry discloses a component (308, a consumer device; 303, a front-facing camera that is arranged on the same side as; 305 a video display screen;) that can display a silhouette or outline of a face/head on a display (305, a video display screen), along with an overlay (alignment indicia is overlaid onto the live video feed) of a dynamically-captured image of the user's face. The user can then adjust one or more settings at the portable consumer device and/or reposition the portable consumer device so that the user's face is aligned with the silhouette or outline (to assist the patient maintain their face within a predetermined target zone). This embodiment can be useful to ensure the portable device is positioned at a proper distance/alignment prior to selecting and performing the test.
It would have been obvious to a person of ordinary skill in the art at the time of filing of the instant application to apply the method of aligning an overlay with the image of the user’s face taught by Berry to a portable device used in the system and method of US 11819313 in view of Frank for the purpose of ensuring the portable device is positioned at a proper distance/alignment prior to selecting and performing the test.
Claims 8 & 9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11819313 in view of Frank as applied to claims 1 & 3 above, and further in view of Wong (US 2022/0287563).
With respect to instant claims 8 & 9
Claim 8
The method of claim 7, wherein the computer program application comprises a clock and is configured to provide the patient at least one of a reminder to conduct the photoplethysmogram at predetermined time intervals, or an alert that a photoplethysmogram has been missed.
The method of claim 1 (as above),
The method of claim 7, wherein the computer program application comprises a clock and is configured to provide the patient at least one of a reminder to conduct the photoplethysmogram at predetermined time intervals, or an alert that a photoplethysmogram has been missed.
Claim 9
The method of claim 8, wherein the predetermined time interval comprises the collection time period, and wherein the collection time period is four hours long.
The method of claim 1 (as above),
The method of claim 8, wherein the predetermined time interval comprises the collection time period, and wherein the collection time period is four hours long.
The claims of existing US 11819313 in view of Frank do not recite the computer program application comprises a clock and is configured to provide the patient at least one of a reminder to conduct the photoplethysmogram at predetermined time intervals, or an alert that a photoplethysmogram has been missed, nor do the recite wherein the predetermined time interval comprises the collection time period, and wherein the collection time period is four hours long.
However, attention is brought to the Wong reference which teaches a behavior modification methods and systems (abstract) that facilitates lifestyle changes necessary to maintain his or her health or recover from ailments or medical procedures ([0003]). This system includes having a device with a processor provide behavior-support intervention which can include electronic alarms, reminders, and messages ([0006]) that providing help when the individual begins to fail in adhering or continuing with the prescribed behavior modification ([0004]). These behavior modifications include structured collection procedures where biomarker data (blood glucose value, an interstitial glucose value, an HbA1c value, a heart rate measurement, a blood pressure measurement, lipids, triglycerides, cholesterol, and the like as described in [0035]) is measured under prescribed conditions such as time related conditions ([0039]).
Wong discloses the use of an internal clock (computer program application comprises a clock) that provides date and time stamps to a processor for the purpose of tracking when a health event such as glucose measurement or inulin administration occurs ([0064]). Using this timing information, the software also permits reminders for biomarker measurements. For example, in one embodiment, the processor provides an alarm and/or alert message for a reminder via the indicator and/or on the display, respectively, to provide a measurement (provide the patient at least one of a reminder to conduct the photoplethysmogram) ([0151]).
Further attention is also drawn to the Frank reference, which also teaches “the computer receives additional measurements of the user taken with the wearable device at least four hours after the current measurements were taken” (the predetermined time interval comprises the collection time period, and wherein the collection time period is four hours long) in [0328]).
It would have been obvious to one of ordinary skill in the art at the time of filing of the instant application to apply the method of providing an alarm or alert reminder for a scheduled health activity taught by Wong to the method of US 11819313 in view of Frank for the purpose of providing help when the individual begins to fail in adhering or continuing with the behavior modification of taking regular PPG measurements, and to apply the four hour time interval taught by Frank to the method taught by Gannon as described above.
Claim Rejections - 35 USC § 102
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.
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, 6-7, 10-11, 14-15, & 17-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Frank.
With regard to claim 1 Frank teaches a method comprising (“Fig.s 1 & 2 and “a wearable-based system that can help determine in a privacy-preserving manner whether a user is healthy” in [0015]): receiving temperature data from a continuous temperature monitor worn by a patient, (“842 in Fig. 1, “The wearable device comprising… a second sensor configured to measure a temperature of the user” in [0015]) the continuous temperature monitor comprising a flexible patch configured to be attached to the patient's skin, (“the temperature sensor 842 may be a contact temperature sensor, such as a sensor embedded in… a patch attached to a region of the user's body” in [0148]) the flexible patch comprising a temperature sensor that is configured to automatically collect at least one temperature of the patient every five minutes during a collection time period; (“thermal measurements upon which the one or more operations are performed are taken during a window of time of a certain length… the window may be shorter than one or more of the following durations: five seconds, fifteen seconds, one minute, five minutes” in [0489]) receiving at least one vital sign data from a rPPG device (“the smartglasses may include some of the following sensors: a photoplethysmogram (PPG) sensor that measures blood flow and blood oxygen saturation” in [0016]) configured to conduct a remote photoplethysmogram (rPPG) comprising a plethysmogram that is optically obtained by detection of blood volume changes in the microvascular bed of tissue of the patient via a non-contact and non-invasive transdermal optical imaging using a camera to measure and analyze variations in the light reflected off the patient's skin; (“a non-contact camera that captures images of the skin, where a computer extracts the PPG signal from the images using an imaging photoplethysmography (iPPG) technique.” in [0106] and “a PPG signal is recognizable from color changes in a region in images” refer to effects of blood volume changes due to pulse waves that may be extracted from a series of images of the region” in [0413]) and transmit a notification of a result of the analysis to a personal device of the patient and/or to a clinician, wherein the notification comprises an alert when the result of the analysis indicates the fever (“For example, their health scores may be below a threshold. In this example, a user interface may be utilized to notify a symptomatic user” in [0354] and “Detecting fever and intoxication from images and temperatures” in [0147]).
With regard to claim 2 Frank teaches the method of claim 1, wherein the at least one vital sign data comprises at least one of the patient's pulse or heart rate, heart rate variability, blood pressure, blood-oxygen levels, and/or respiratory rate (“Some examples of physiological signals that may be used to calculate the health score include one or more of the following: heart rate, blood oxygen saturation, respiration rate, skin and/or core body temperature, blood pressure” in [0017]).
With regard to claims 3 and 6 Frank teaches the method of claim 1, the camera is part of the rPPG device comprising at least one of a smartphone, tablet, or other computer device, which would be a personal device of the patient (“Fig. 14A and “The device 802 is configured to measure first and second signals indicative of photoplethysmogram signals… There are various types of devices which the device 802 may be or include. In one embodiment, the device 802 is a video camera that is not head-mounted, such as a camera of a mobile phone, a camera of a laptop, and/or a webcam” in [0399-0400]).
With regard to claim 7 Frank teaches the method of claim 3, wherein the rPPG device comprises a processor and non-transient memory that is configured to execute a computer program application to operate the camera and obtain the at least one vital sign data by conducting the remote photoplethysmogram using the camera (802, 803, and 800 in Fig. 14A and “The steps described below may be performed by running a computer program having instructions for implementing the method. Optionally, the instructions may be stored on a computer-readable medium, which may optionally be a non-transitory computer-readable medium. In response to execution by a system including a processor and memory, the instructions cause the system to perform the following steps” in [0458]).
With regard to claim 10 Frank teaches the method of claim 1, wherein the method further comprises an on-body sensor that is physically worn upon the patient's body to conduct an auxiliary photoplethysmogram (PPG) scan (“the computer 847 receives additional measurements of the user 874 taken with the wearable device 840 at least four hours after the current measurements were taken” in [0328]).
With regard to claim 11 Frank teaches the method of claim 1, wherein the notification (“A user interface (UI) may be utilized, in some embodiments, to notify the user and/or some other entity, such as a caregiver, about the physiological response and/or present an alert responsive to an indication that the extent of the physiological response reaches a threshold” in [0510]) from the remote server-side computer system is transmitted in substantially real time with the receipt of the temperature data, the at least one vital sign data, and result of the analysis (“A user interface (UI) may be utilized, in some embodiments, to notify the user and/or some other entity, such as a caregiver, about the physiological response and/or present an alert responsive to an indication that the extent of the physiological response reaches a threshold” in [0510]).
With regard to claim 14 Frank teaches the method of claim 1, wherein analyzing the temperature data and the at least one vital sign data for indication of a fever comprises comparing the temperature data and the at least one vital sign data to respective predetermined thresholds (“In one example, the physiological signal is body temperature, and the calculating of the health score utilizes a function that returns a value that is below the first threshold when a current body temperature is greater than an expected body temperature by at least a certain margin” in [0027]).
With regard to claim 15 Frank teaches the method of claim 1, wherein analyzing the temperature data and the at least one vital sign data for indication of a fever comprises comparing a rate of increase of the temperature data and the at least one vital sign data to respective predetermined thresholds (“For example, a fast increase due to an allergic reaction may correspond to an increase of more than 0.8° C. within a period of less than 10 minutes” in [0701]”).
With regard to claim 17 & 18 Frank teaches the method of claim 1, wherein the remote server-side computer system further provides a visual clinician dashboard that displays the temperature data and at least one vital sign data from one or more patients upon a computer screen (Fig. 44 & 59 and “FIG. 44 illustrates an exemplary UI that shows statistics about the dominant nostril and mouth breathing during the day” in [0566]) wherein the temperature data and the at least one vital sign data are time-correlated on the visual clinician dashboard (“FIG. 59 illustrates a scenario in which a system (which measures the forehead, right and left periorbital areas, nose, and below the nostrils) suggests to the user to take a break in order to reduce the stress level of the user” in [0851], see annotated figure 59 below).
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With regard to claim 19 Frank teaches the method of claim 17, wherein the remote server-side computer system causes the visual clinician dashboard to display the temperature data and at least one vital sign data in substantially real time (“the computer 486 may provide real-time indications of potential stressors. Upon detecting that those potential stressors … the UI notifies the user” in [0899].).
With regard to claim 20 Frank teaches the method of claim 17, wherein the visual clinician dashboard further displays the alert when the result of the analysis indicates the fever (“A user interface (UI) may be utilized, in some embodiments, to notify the user and/or some other entity, such as a caregiver, about the physiological response and/or present an alert responsive to an indication that the extent of the physiological response reaches a threshold. The UI may include a screen to display the notification and/or alert” in [0510]).
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 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Frank in view of Berry.
With regard to claims 4-5, Frank teaches the method of claim 3 (as above).
Frank does not teach wherein the camera of the rPPG device is a front-facing camera that is arranged on the same side as a video display screen of the rPPG device that displays a live video feed of the patient's face when the remote photoplethysmogram scan is conducted, nor wherein alignment indicia is overlaid onto the live video feed to assist the patient maintain their face within a predetermined target zone during the remote photoplethysmogram scan.
However, Berry teaches systems, methods, and computer program products related to interactive medical testing and the diagnosis of medical conditions using portable consumer devices ([0003]). Self-testing and self-examination have become increasingly common alternatives to travel to a medical facility. However, these self-diagnosis tests, which are often designed and/or carried out without professional guidance or expert knowledge, are frequently fraught with inaccuracies resulting from a consumer performing the test incorrectly. To facilitate self-testing or self-examination in a manner that can eliminate much of the inaccuracy, Berry teaches an invention that can be used to help improve the foregoing state of medical testing, particularly self-testing, by providing rich, interactive medical testing environments through computing devices, such as portable consumer devices which are linked to professional systems ([0040-0042]).
In Fig. 3 and in [0069] Berry discloses a component (308, a consumer device; 303, a front-facing camera that is arranged on the same side as; 305 a video display screen;) that can display a silhouette or outline of a face/head on a display (305, a video display screen), along with an overlay (indicia is overlaid onto the live video feed) of a dynamically-captured image of the user's face. The user can then adjust one or more settings at the portable consumer device and/or reposition the portable consumer device so that the user's face is aligned with the silhouette or outline (to assist the patient maintain their face within a predetermined target zone). This embodiment can be useful to ensure the portable device is positioned at a proper distance/alignment prior to selecting and performing the test.
It would have been obvious to a person of ordinary skill in the art at the time of filing of the instant application to apply the method of aligning an overlay with the image of the user’s face taught by Berry to a portable device used in the system taught by Frank for the purpose of ensuring the portable device is positioned at a proper distance/alignment prior to selecting and performing the test.
Claims 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Frank in view of Wong.
With regard to claims 8-9, Frank teaches the method of claim 7 (as above) and wherein the predetermined time interval comprises the collection time period, and wherein the collection time period is four hours long (“the computer 847 receives additional measurements of the user 874 taken with the wearable device 840 at least four hours after the current measurements were taken” in [0328])).
Frank does not teach wherein the rPPG device comprises a processor and non-transient memory that is configured to execute a computer program application to operate the camera and obtain the at least one vital sign data by conducting the remote photoplethysmogram using the camera.
However, Wong teaches a behavior modification methods and systems (abstract) that facilitates lifestyle changes necessary to maintain his or her health or recover from ailments or medical procedures ([0003]). This system includes having a device with a processor provide behavior-support intervention which can include electronic alarms, reminders, and messages ([0006]) that providing help when the individual begins to fail in adhering or continuing with the prescribed behavior modification ([0004]). These behavior modifications include structured collection procedures where biomarker data (blood glucose value, an interstitial glucose value, an HbA1c value, a heart rate measurement, a blood pressure measurement, lipids, triglycerides, cholesterol, and the like as described in [0035]) is measured under prescribed conditions such as time related conditions ([0039]).
Wong discloses the use of an internal clock (computer program application comprises a clock) that provides date and time stamps to a processor for the purpose of tracking when a health event such as glucose measurement or inulin administration occurs ([0064]). Using this timing information, the software also permits reminders for biomarker measurements. For example, in one embodiment, the processor provides an alarm and/or alert message for a reminder via the indicator and/or on the display, respectively, to provide a measurement (provide the patient at least one of a reminder to conduct the photoplethysmogram) ([0151]).
Further attention is also drawn to the Frank reference, which also teaches “the computer receives additional measurements of the user taken with the wearable device at least four hours after the current measurements were taken” (the predetermined time interval comprises the collection time period, and wherein the collection time period is four hours long) in [0328]).
It would have been obvious to one of ordinary skill in the art at the time of filing of the instant application to apply the method of providing an alarm or alert reminder for a scheduled health activity taught by Wong to the system taught by Frank for the purpose of providing help when the individual begins to fail in adhering or continuing with the behavior modification of taking regular PPG measurements.
Claims 12-13 & 16 are rejected under 35 U.S.C. 103 as being unpatentable over Frank in view of Gannon.
With regard to claims 12-13 & 16, Frank teaches the method of claim 1 (as above), wherein the remote server-side computer system is remotely connected to the continuous temperature monitor, the rPPG device (847 in Fig. 1 and “These sensors may provide signals that can be utilized by the computer 847 to determine the user's health state, as discussed further below” in [0144]), and to the clinician via a network (“In some embodiments, at least some of the calculations attributed to the computer 847, and possibly all of those calculations, may be performed on a remote processor that is not on the wearable device 840, such as a processor on the user's smartphone and/or a cloud-based server” in [0157]).
Frank does not teach wherein each of the flexible patch and the rPPG device comprise a wireless transmitter, wherein the patient is undergoing or has undergone chimeric antigen receptor T-cell (CAR-T) therapy, and the fever is caused by cytokine release syndrome, nor wherein the notification from the remote server-side computer system further comprises an instruction to the patient to seek medical attention when the result of the analysis indicates the fever.
However, Gannon teaches that patients undergoing Car-T therapy are at risk for an increase in cytokine levels which can progress to cytokine release syndrome (CRS), a condition in which can escalate and progress quickly to life-threatening vasodilatory shock, capillary leak, hypoxia, and end-organ dysfunction ([0004]). Gannon also teaches that the fever associated with CRS has certain distinguishing characteristics that may be used for identification/diagnosis of CRS and/or the onset of fever, generally. In other words, CRS temperature and fever profiles (e.g., those shown and discussed below) are distinct from other known temperature and fever profiles caused by other known disease conditions and/or treatments, such as those from a transplant patient that has not received CAR-T therapy and is therefore is not experiencing a CRS event or those from a cancer patient receiving chemotherapy and experiencing a febrile neutropenia event. Accordingly, CRS fevers (and fevers associated with other causes) have profiles that can be identified (thus identifying CRS or the other cause) by analyzing temperature data collected by the above-described temperature monitors [0019] (wherein the patient is undergoing or has undergone chimeric antigen receptor T-cell (CAR-T) therapy, and the fever is caused by cytokine release syndrome). Given the rapid nature of fevers associated with CRS traditional temperature measurements occurring only once every two to four hours per the current standard of care are insufficient to provide the desired level of care, but continuous temperature monitoring can be utilized to recognize such temperature and fever profiles ([0026]) so that early detection of fever in patients susceptible to CRS can help identify CRS onset so that it may be timely treated [0016]. To perform this monitoring, Gannon teaches a body temperature logging patch (200 in Fig. 8) that can record a patient's temperature at a frequency of once every ten seconds ([0018]) and may communicate with a personal device (204 in Fig. 8) via any short range communication including, for example, Bluetooth, near field communication (wherein each of the flexible patch and the rPPG device comprise a wireless transmitter), and the like. The collected temperature data is then transmitted over a network (e.g., the Internet, 206 in Fig. 8) to a server-side computer system (208 in Fig. 8). Gannon also teaches a notification comprises an alert and an instruction to the patient to seek medical attention when the result of the analysis indicates the fever ([0006]) (the notification from the remote server-side computer system further comprises an instruction to the patient to seek medical attention when the result of the analysis indicates the fever).
It would have been obvious to one of ordinary skill in the art at the time of filing of the instant application to apply the wireless transmitter, CRS fever profiles, and instructions to seek medical attention taught by Gannon to the continuous health monitoring system and alerts taught by Ari to allow early detection of fever in patients susceptible to CRS so that it may be timely treated.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 20230197289 A1, published 2023-06-22 (WO 2021222601 is an equivalent document)
Abstract - Systems and methods for monitoring the spread of pandemic pneumonia using IOT technology is provided. Sensor data from wearable devices is utilized to determine: a probability of developing complications from a pandemic for an unexposed user using existing indicators of the wearer’s health; the impact of lockdown measures on health; a probability that a user exposed to the pathogen experiences complications; and a probability of various disease stages for the user including normal, asymptomatic, pre-symptomatic, symptomatic, complication development and recovery is provided.
Field of Invention - The invention relates to the tracking of transmission, disease stages, vulnerability to complications and impact of regulations to control the spread of a novel pathogen using location and physiological data gathered by mobile sensors including wearables and GPS.
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/W.P.A./ Examiner, Art Unit 3792
/UNSU JUNG/ Supervisory Patent Examiner, Art Unit 3792
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