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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 2/25/2025 has been entered.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, 3, 5-14, and 17-20 as rejected under 35 U.S.C. §§ 101 and 103 have been fully considered but they are not persuasive.
On pp. 8-9, Applicant states that the technological problem of enabling remote, non-contact monitoring of physiological information of a patient, in environments where traditional contact-based patient monitoring systems are unavailable, impractical, or desirable is specifically solved by the technological solution provided by the claimed invention, stating that “while humans can observe patients visually, they cannot replicate the precision of non-contact sensors to determine physiological characteristics via computer-executed operations.”
This is not found persuasive because, as stated previously, nothing in the claims precludes a person from performing the claimed abstract idea. As identified in the rejection below, multiple limitations have been identified as comprising a judicial exception in the form of a process that a person is capable of performing mentally, or with the aid of pen and paper. Particularly in the independent claims, no particularity, precision, or specificity of the physiological data or motion data is claimed, and broadly interpreted, these “physiological characteristic” and “position characteristic” can be simply described as a person deciding if a video capture is of another user who is sleeping, or not sleeping, and in what position. Applicant states that the claimed invention is directed to a system that requires capabilities beyond the mental capacity of a human person visually observing a patient. However, Applicant has refrained from claiming more than elements that structurally replicate the capability of a human person (a video camera as a non-contact sensor, for example, replicates human visual and auditory observation), and algorithmic steps that require complexity beyond what is a human mind is reasonably capable of.
The structural and functional elements of the claimed plurality of imaging sensors capturing images, processor, computer-readable medium, transmitting/receiving, outputting, and displaying have been identified as additional elements in the rejection below. However, they have been determined individually and in combination not to transform the abstract idea into patent eligible subject matter. The claims appear to be directed to implementing the abstract idea on a general purpose computer, using imaging sensors (such as a video camera) and display to nominally tie the abstract idea to a field of use, but ultimately not integrating the abstract idea with a practical application or performing more than insignificant extra-solution activity.
On p. 9, Applicant states that “classification of values against configurable thresholds with alerts based on the classified one or more values exceeding the configurable thresholds transmitted to a remote display for real-time display to a caregiver” explicitly require specific computer implementation beyond mental performance.
It is the examiner’s position that “classification of values against configurable thresholds with alerts based on the classified one or more values exceeding the configurable thresholds” is performable by a human mentally or with the aid of pen and paper. A person is capable of comparing values to a test threshold and thereby classifying the values in the categories and determining an alert status when a value exceeds a threshold for comparison. Transmitting to a remote display for real-time display is considered by the examiner to be a specific computer function, however as an additional element, display and generic computer functions such as transmitting are routine extra-solution activities and do not integrate the abstract idea into a practical application or technical field.
Additionally on p. 9, Applicant goes on to discuss that the claimed “video capture camera, an infrared camera, an infrared emitter, and a thermal camera” are disclosed in the specification as being used to enable determinations that are inherently beyond human capacity: analyzing skin coloration between image frames to derive blood perfusion, and analyzing changes in pixelation between the nose and mouth to determine tidal respiration volume.
The examiner does not dispute that these exemplary calculations of a pixel level imaging analysis may not be considered within the capabilities of the human mind. However, Applicant has not claimed any of these. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., analyzing skin coloration between image frames to derive blood perfusion, and analyzing changes in pixelation between the nose and mouth to determine tidal respiration volume) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
However, the derivation of skin coloration changes between frames of a video and pixelation for determining tidal volume is not an inherent property of the elements which are claimed such as using a video camera, extracting physiological and position information (such as sleep status and position), analyzing pattern in the aggregate of received video (such as a sleep schedule), etc. Applicant may wish to positively claim the elements of the disclosed invention that are beyond the capability of mental work, and integrated into the specific technical field upon which Applicant’s arguments rely.
On p. 11, Applicant contends that the modification in view of the Tiron reference does not teach classification of values to represent at least one physiological characteristic performed on imaging data, further stating that the claims require specific imaging sensor types (video capture camera, infrared camera, infrared emitter, and thermal camera) and that Tiron is “primarily” an acoustic and radio-frequency sensing system.
This is not found persuasive because the classification performed by Tiron is specifically performed on imaging data, including video capture and IR, and thermography (¶¶[0052-0053]) used in the disclosed methods of Tiron.
On p. 12, Applicant states that the “actual classification method” of Tiron uses acoustic and RF signal processing only while acknowledging that Tiron does teach cameras, LIDAR, and other optical sensors.
This is not found persuasive as in the description of camera and IR sensors of Tiron found in ¶¶[0052-0053] the video and IR data acquired is specifically used to determine one or more cough events, a function performed by the classifier. Fig. 7B-2 also makes clear that acoustic information is an input to the classifier, as well as additional characteristics “Motion/Bio-Physical/Sound Characteristic Detection”.
The remaining arguments on p. 12 are directed to whether Levi teaches the claimed classification, which is taught in combination by Levi and Tiron as indicated above. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Claim Rejections - 35 USC § 101
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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, 3, 5-14, and 17-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more.
This analysis in view of 35 U.S.C. § 101 is based on MPEP § 2106, please see
this section of the MPEP for additional information.
First, the broadest reasonable interpretation of the claim as a whole is
established:
Claims 1, 13 and 20 claim systems and a method comprising imaging sensors, a processor, and computer-readable medium for aggregating imaging data, analyzing patterns at targeted data segments of the imaging data using algorithms to classify the values and represent a physiological state and position of a patient, output data and display.
Claims 3, 14 include additional algorithmic processes for configuring the algorithm and data capture.
Claims 9-10, 12, 17-19 add additional derived parameters from a plurality of possible sensors.
Claims 5-6, 8, 13 include a housing that holds the sensors, processor, and memory.
Claims 7, 11 include a user interface.
Step 1 of the analysis is the question: “Is the claim to a process, machine,
manufacture, or composition of matter?” and the answer is determined to be yes, as the
claims as a whole are directed to a manufacture and a method.
For Step 2, the preliminary question is whether the eligibility of the claim is self-
evident. The answer is determined to be no, as the claim is not immediately self-evident
as statutory.
Step 2A Prong One: Is the claim directed to a law of nature, a natural phenomenon (product of nature) or an abstract idea?
A claim is directed to a judicial exception when a law of nature, a natural
phenomenon, or an abstract idea is recited (i.e., set forth or described) in the claim.
While the terms “set forth” and “describe” are thus both equated with “recite”, their
different language is intended to indicate that there are different ways in which an
exception can be recited in a claim. For instance, the claims in Diehr set forth a
mathematical equation in the repetitively calculating step, the claims in Mayo set forth
laws of nature in the wherein clause, meaning that the claims in those cases contained
discrete claim language that was identifiable as a judicial exception. The claims in Alice
Corp., however, described the concept of intermediated settlement without ever explicitly using the words “intermediated” or “settlement.”
Claim 1 (and equivalently in claim 13/20) recites the following limitations:
aggregate the received imaging data
analyze patterns at targeted data segments of the aggregated imaging data using one or more algorithms to determine one or more values
classify the one or more values determined from the analyzed patterns to represent at least one physiological characteristic and at least one position characteristic of the individual wherein the values are classified against configurable thresholds to represent a physiological state determination
The above identified elements comprise an explicit claim recitation of an abstract idea. Therefore, rather than merely involve a judicial exception, the claims are directed to the identified judicial exception.
This claim language is identified as an abstract idea, because in MPEP §
2106.04(a)(2) III B. this language is similar to concepts relating to organizing or
analyzing information in a way that can be performed mentally or are analogous to
human mental work. For example, Synopsys, Inc. v. Mentor Graphics Corp., 839 F.3d
1138, 120 USPQ2d 1473 (Fed. Cir. 2016). In Synopsys, the patentee claimed methods
of logic circuit design, comprising converting a functional description of a level sensitive
latch into a hardware component description of the latch. 839 F.3d at 1140; 120 USPQ2d at 1475. Although the patentee argued that the claims were intended to be
used in conjunction with computer-based design tools, the claims did not include any
limitations requiring computer implementation of the methods and thus do not involve
the use of a computer in any way. 839 F.3d at 1145; 120 USPQ2d at 1478-79. The
court therefore concluded that the claims “read on an individual performing the claimed
steps mentally or with pencil and paper,” and were directed to a mental process of
“translating a functional description of a logic circuit into a hardware component
description of the logic circuit.” 839 F.3d at 1149-50; 120 USPQ2d at 1482-83.
In the instant case, the identified abstract idea is similar to Synopsys because the
language reads on an individual aggregating, analyzing, and classification mentally or with a pencil and paper. They do not require any computer implementation and therefore are directed to a mental process of watching or evaluating image data from a camera and determining the physiological state or positioning of the individual.
Yes. The claim is directed to an abstract idea.
Step 2A Prong Two: Does the claim recite additional elements that integrate the judicial exception into a practical application?
First, the additional elements are identified.
In claim 1 and 20: plurality of imaging sensors, processor, computer-readable medium, receiving imaging data from the imaging sensors, outputting data corresponding to classified values, displaying output data, video capture camera, infrared camera, infrared emitter, thermal camera, transmitting, and a display
Claims 5, 8, 13: housing
Claims 7, 11: user interface
The sensors are recited broadly as any of a variety of imaging sensors without reference to a particular arrangement or configuration. The imaging sensors are only nominally tied to the abstract idea and the data acquisition is all performed as pre-solution activity to the abstract idea claimed. Therefore the claimed sensors amount to mere data gathering and considered an insignificant extra-solution activity. A generally recited portable housing is also considered only a nominal tie to a field of use and not providing a particular machine.
The processing circuitry, memory, display, user interface, and transmitting/receiving appears to be an addition of a general purpose computer post-hoc to an abstract idea and is therefore not considered to transform the abstract idea into patent eligible subject matter. Use of a display is considered to be insignificant extra-solution activity as to displaying certain aspects of the abstract idea.
The remaining features in the claims are directed to further specifying the intended use but do not impose further limits to the recited system because they are generally linking the use of the judicial exception to a particular field of use or technological environment.
Step 2B: Does the claim recite additional elements that amount to significantly
more than the judicial exception?
The sensors are recited broadly as any of a variety of imaging sensors (video camera, infrared, infrared emitter, thermal camera) without reference to a particular arrangement or configuration. The imaging sensors are only nominally tied to the abstract idea and the data acquisition is all performed as pre-solution activity to the abstract idea claimed. Therefore the claimed sensors amount to mere data gathering and considered an insignificant extra-solution activity. A generally recited portable housing is also considered only a nominal tie to a field of use and not providing a particular machine.
The processing circuitry, memory, display, user interface, and transmitting/receiving appears to be an addition of a general purpose computer post-hoc to an abstract idea and is therefore not considered to transform the abstract idea into patent eligible subject matter. Use of a display is considered to be insignificant extra-solution activity as to displaying certain aspects of the abstract idea.
The remaining features in the claims are directed to further specifying the intended use but do not impose further limits to the recited system because they are generally linking the use of the judicial exception to a particular field of use or technological environment.
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.
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.
Claim(s) 1, 3, 5-9, 11-14, 17, and 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Levi et al. (U.S. Patent Application Publication No. 2021/0401298) hereinafter referred to as Levi; in view of Tiron et al. (U.S. Patent Application Publication No. 2023/0190140) hereinafter referred to as Tiron.
Regarding claim 1, Levi teaches a system for remotely monitoring an individual (Abstract), the system comprising:
a plurality of imaging sensors capturing images of a target individual, wherein the plurality of imaging sensors are non-contact sensors, and wherein non-contact refers to the absence of physical contact with the individual (Fig. 3A, cameras, Figs. 15A-C, ¶¶[0134-0135]), the plurality of imaging sensors comprising one or more of: a video capture camera; an infrared camera; an infrared emitter; and a thermal camera (Fig. 3A, cameras, Figs. 15A-C, ¶¶[0134-0135]);
a processor (¶[0135] processing unit element 12); and
a computer-readable medium storing instructions (¶[0134], ¶[0137] memory element 28) that are operative upon execution by the processor to:
receive imaging data from the plurality of imaging sensors, wherein the plurality of imaging sensors are configured to extract physiological and position information from the target individual without using physical contact sensors (¶[0135]);
aggregate the received imaging data (¶¶[0163-0164]);
analyze patterns at targeted data segments (Fig. 11, ROI) of the aggregated imaging data using one or more algorithms to determine one or more values (Fig. 11, analysis flowchart for patterns and determining values, ¶[0155]);
classify the one or more values determined from the analyzed patterns to represent at least one position characteristic (Fig. 11, ¶[0196], ¶[0207] posture); and
output data corresponding to the classified one or more values (¶[0158]); and
display the output data on a display (¶[0136], ¶[0156] GUI module showing data to the user), wherein the output display data is transmitted to a remote display for real-time (¶[0123], ¶[0126] real-time system, ¶[0170] real-time processing) display to a caregiver (¶[0165] caregiver responsible for monitoring a patient), the output data comprises one or more alerts based on the classified one or more values exceeding the configurable thresholds (¶[0165] alerts, electronic messages sent to carefgiver if any of the values are abnormal).
Levi does not teach classifying the one or more values determined from the analyzed patterns to represent at least one physiological characteristic, wherein the values are classified against configurable thresholds to represent a physiological state determination.
Attention is brought to the Tiron reference, which teaches a remote monitoring system including imaging sensors (¶[0040], Fig. 7C-1 monitoring system 7000) sensing physiological parameters remotely (¶[0052]) and classifying the one or more values determined from analyzed patterns (¶[0067]) to represent at least one physiological characteristic (¶[0068] classifying may include identifying one of an affirmation and a negation of a presence of a number of sleep disordered breathing events exceeding a threshold for a sleep session, ¶¶[0069-0070] sleep stage cluster flag based on similar process), wherein the values are classified against configurable thresholds to represent a physiological state determination (¶[0068] classifying may include identifying one of an affirmation and a negation of a presence of a number of sleep disordered breathing events exceeding a threshold for a sleep session, ¶¶[0069-0070] sleep stage cluster flag based on similar process) in real time (¶[0333], ¶[0598]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the system of Levi to include classification of analyzed physiological values to represent a physiological characteristic, as taught by Tiron, because simple, easy to access sleep screening may have a significant societal benefit (Tiron ¶[0022]) and because unobtrusive sensing provides a more complete methodology for monitoring a user (Tiron ¶[0214]).
Regarding claim 3, Levi as modified teaches the system of claim 1.
Levi further teaches wherein the values are classified against configurable areas of interest to represent the positioning of the individual (¶[0030], ¶[0171]).
Regarding claim 5, Levi as modified teaches the system of claim 1.
Levi does not teach a housing that houses the plurality of imaging sensors.
Attention is drawn to the Tiron reference, which teaches a housing that houses the plurality of imaging sensors (Fig. 7C-1, element 7000 houses the unobtrusive and contactless sensors in a housing).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the system of Levi to a housing for the imaging sensors, as taught by Tiron, because simple, easy to access sleep screening may have a significant societal benefit (Tiron ¶[0022]) and because unobtrusive sensing provides a more complete methodology for monitoring a user (Tiron ¶[0214]).
Regarding claim 6, Levi as modified teaches the system of claim 5.
Tiron further teaches the processor and computer readable medium disposed in the housing, and performing the receiving, aggregating, analyzing, classifying, and outputting the data corresponding to the classified one or more values (¶[0228] integrated with processing device).
Regarding claim 7, Levi as modified teaches the system of claim 6.
Levi further teaches comprising a display that is configured to display a user interface (UI) indicative of the output data corresponding to the classified one or more values (¶¶[0155-0156]).
Regarding claim 8, Levi as modified teaches the system of claim 5.
Tiron further teaches wherein the housing is portable such that it can be readily moved from a first location to a second location (Fig. 7C-1, element 7000 houses the unobtrusive and contactless sensors in a housing which is self-evidently portable).
Regarding claim 9, Levi as modified teaches the system of claim 1.
Levi further teaches wherein the plurality of imaging sensors capturing images of a target individual are configured to capture one or more of the following physiological characteristics for a target patient:
respiration; heart rate; and temperature (¶[0123] heart rate, breathing rate, and body temperature), and
wherein the plurality of imaging sensors capturing images of a target individual are configured to capture one or more of the following position characteristics for a target patient:
eye movement; head movement; and body movement (¶[0184]).
Regarding claim 11, Levi as modified teaches the system of claim 1.
Tiron further teaches comprising a display that is configured to display a user interface (UI) indicative of one or more physiological conditions of a target patient (¶[0457], ¶[0462]), and a motion condition of the target patient.
Regarding claim 12, Levi as modified teaches the system of claim 11.
Levi further teaches the UI comprising indicators of one or more of the following for a target patient: respiration condition; temperature condition; position; movement; real-time images; heart rate condition; and medical background and instructions (Fig. 14, ¶¶[0155-156]).
Regarding claims 13-14, 17 and 19/20, the claim is directed to a system comprising substantially the same subject matter as claims 1-5, 9, and 11-12/1 and is rejected under substantially the same sections of Levi and Tiron.
Claim(s) 10 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Levi and Tiron as applied to claims 1 and 13 above, and further in view of Addison et al. (U.S. Patent Application Publication No. 2019/0209046) hereinafter referred to as Addison.
Regarding claims 10 and 18, Levi as modified teaches the system of claim 9/13.
Levi further teaches heart rate is indicated by blood perfusion (¶[0169]); and temperature is indicated by forehead temperature, distal temperature, global temperature, and/or ROI temperature (¶[0160]), and
wherein each of blood perfusion, and temperature are determined based upon imaging data received from the plurality of imaging sensors without using physical contact sensors (Fig. 3A, cameras, Figs. 15A-C, ¶¶[0134-0135]).
Levi as modified does not teach respiration is indicated by tidal respiration volume; wherein tidal respiration volume is determined based upon imaging data received from the plurality of imaging sensors without using physical contact sensors.
Attention is drawn to the Addison reference, which teaches respiration indicated by tidal respiration volume (¶[0081], ¶[0083], ¶[0087]); wherein tidal respiration volume is determined based upon imaging data received from the plurality of imaging sensors without using physical contact sensors (Fig. 1, contactless remote camera sensor, ¶¶[0081-0082]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the system of Levi as modified to include tidal respiration volume monitoring, as taught by Addison, because it improves recordkeeping, patient care, error rate, accuracy, and overall monitoring of patients (Addison ¶¶[0078-0079]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMANDA L STEINBERG whose telephone number is (303)297-4783. The examiner can normally be reached Mon-Fri 8-4.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Unsu Jung can be reached at (571) 272-8506. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/AMANDA L STEINBERG/Examiner, Art Unit 3792
Prosecution Insights