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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on October 30, 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings filed on October 30, 2024 are accepted.
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 a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Step 1 of the subject matter eligibility test (see MPEP 2106.03).
Claim 1 is directed to “a system” which describes one of the four statutory categories of patentable subject matter, i.e. a machine or manufacture.
Claim 8 is directed to “a method” which describes one of the four statutory categories of patentable subject matter, i.e. a process.
Claim 15 is directed to “a system” which describes one of the four statutory categories of patentable subject matter, i.e. a machine or manufacture.
Each of Claims 1-20 has been analyzed to determine whether it is directed to any judicial exceptions.
Step 2A of the subject matter eligibility test (see MPEP 2106.04).
Prong One:
Claims 1, 8 and 15 recite (“sets forth” or “describes”) the abstract idea of “managing personal behavior, remotely monitoring a patient” (MPEP 2106.04(a)(2).I.), substantially as follows: “perform a base module to remotely monitor the patient; generate a clinical condition vector using data collected by the base module; receive one or more clinical modules from a module store, the one or more clinical modules received based on the clinical condition vector; and perform the one or more clinical modules to remotely monitor the patient.”
In claims 1, 8 and 15, the above recited steps are managing personal behaviors, remotely monitoring a patient. This arrangement amounts to both managing personal behavior and interactions between people. In sum, we determine that Prong 1 recites a judicial exception, and proceed to Step 2A, Prong 2.
Therefore, each of the above steps are grouped as managing personal behaviors hence an abstract idea.
Claims 1, 8 and 15 recite (“sets forth” or “describes”) the abstract idea of “a mental process” (MPEP 2106.04(a)(2).III.), substantially as follows: “perform a base module to remotely monitor the patient; generate a clinical condition vector using data collected by the base module; receive one or more clinical modules from a module store, the one or more clinical modules received based on the clinical condition vector; and perform the one or more clinical modules to remotely monitor the patient.”
In claims 1, 8 and 15, the above recited steps can be practically performed in the human mind, with the aid of a pen and paper or with a generic computer, in a computer environment, or merely using the generic computer as a tool to perform the steps. If a person were to visually examine, i.e., perform an observation, the patient data, either in a printout or an electronic format, he/she would be able to generate a clinical condition vector and remotely monitor the patient based on the clinical module and clinical condition vector via pen and paper. There is nothing recited in the claim to suggest an undue level of complexity in how the patient data and monitoring is occurring. Therefore, a person would be able to perform the identification of peaks mentally or with a generic computer.
Prong Two: Claims 1, 8 and 15 do not include additional elements that integrate the mental process into a practical application.
This judicial exception is not integrated into a practical application. In particular, the claims recites (1) “remotely monitor the patient”
(2) “at least one processing device; and at least one computer readable data storage device storing software instructions that, when executed by the at least one processing device, cause the device to:”.
The steps in (1) represent merely data gathering or pre-solution activities that are necessary for use of the recited judicial exception and are recited at a high level of generality with conventionally used tools (see below Step IIB for further details).
The steps in (2) merely recite generic computer components used to implement the abstract idea on, as tools.
As a whole, the additional elements merely serve to gather and feed information to the abstract idea and to output a notification based on the abstract idea, while generically implementing it on conventionally used tools. There is no practical application because the abstract idea is not applied, relied on, or used in a meaningful way. No improvement to the technology is evident, and the estimated bio-information is not outputted in any way such that a practical benefit is realized. Therefore, the additional elements, alone or in combination, do not integrate the abstract idea into a practical application.
Step 2B of the subject matter eligibility test (see MPEP 2106.05).
Claims 1, 8 and 15 do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above, the claims recite additional steps of (1) “remotely monitor the patient”
(2) “at least one processing device; and at least one computer readable data storage device storing software instructions that, when executed by the at least one processing device, cause the device to:”.
These steps represents mere data gathering, data outputting or pre/post/extra-solution activities that are necessary for use of the recited judicial exception and are recited at a high level of generality.
The recited processors and computer-readable storage medium are generic computer elements (i.d. para. [0043] describing generic computers).
Therefore, none of the Claims 1, 8 and 15 amounts to significantly more than the abstract idea itself.
Accordingly, Claims 1, 8 and 15 are not patent eligible and rejected under 35 U.S.C. 101 as being directed to abstract ideas implemented on a generic computer in view of the Supreme Court Decision in Alice Corporation Pty. Ltd. v. CLS Bank International, et al. and 2019 PEG.
Dependent Claims
The following dependent claims merely further define the abstract idea and are, therefore, directed to an abstract idea for similar reasons:
Claims 3-7, 10-14 and 20 recitations further limits the abstract idea above, generating scores and further monitoring the patient data merely further defines the mental process or managing personal behaviors discussed above.
The following dependent claims merely further describe the extra-solution activities and therefore, do not amount to significantly more than the judicial exception or integrate the abstract idea into a practical application for similar reasons:
Claims 2, 9, and 18 further define the sensors used for insignificant extra-solution activity (data collection).
Claims 16-17 and 19 recitations merely recite data transmission to the output device discussed above as extra-solution activity (data output).
Taken alone and in combination, the additional elements do not integrate the judicial exception into a practical application at least because the abstract idea is not applied, relied on, or used in a meaningful way. They also do not add anything significantly more than the abstract idea. Their collective functions merely provide computer/electronic implementation and processing, and no additional elements beyond those of the abstract idea. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements individually. There is no indication that the combination of elements improves the functioning of a computer, output device, improves technology other than the technical field of the claimed invention, etc. Therefore, the claims are rejected as being directed to non-statutory subject matter.
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 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.
Claims 1-16, 18 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tran et al. (US 2012/0242501 A1) (“Tran”).
Regarding claim 1, Tran discloses A system for remotely monitoring a patient, the system comprising (Abstract and entire document):
at least one processing device (FIG. 1 and [0011], [0302], [0306]); and
at least one computer readable data storage device storing software instructions that, when executed by the at least one processing device, cause the device to (FIG. 1 and [0011], [0058], [0064]):
perform a base module to remotely monitor the patient (FIG. 1 and [0064], [0058] discussing monitoring patient with wearable, heart rate, ECG, blood oxygen, vital signs, etc.);
generate a clinical condition vector using data collected by the base module ([0064], “The server 20 also executes one or more software modules to analyze data from the patient. A module 50 monitors the patient's vital signs such as ECG/EKG and generates warnings should problems occur.” Data is analyzed and condition is determined);
receive one or more clinical modules from a module store, the one or more clinical modules received based on the clinical condition vector ([0064], “The server 20 also executes one or more software modules to analyze data from the patient. A module 50 monitors the patient's vital signs such as ECG/EKG and generates warnings should problems occur.” A warning or alert is a clinical module, based on the determined condition or clinical vector); and
perform the one or more clinical modules to remotely monitor the patient ([0056], “In one embodiment, appliances 8 monitor the patient and activates the camera 10 to capture and transmit video to an authorized third party for providing assistance should the appliance 8 detects that the user needs assistance or that an emergency had occurred.” And [0249 – 0250]).
Regarding claim 2, Tran discloses The system of claim 1, wherein the instructions, when executed by the at least one processing device, further cause the system to: activate one or imaging modalities based on the one or more clinical modules ([0056], “In one embodiment, appliances 8 monitor the patient and activates the camera 10 to capture and transmit video to an authorized third party for providing assistance should the appliance 8 detects that the user needs assistance or that an emergency had occurred.” And [0249 – 0250]).
Regarding claim 3, Tran discloses The system of claim 1, wherein the instructions, when executed by the at least one processing device, further cause the system to: simultaneously perform the one or more clinical modules while continuously performing the base module for remotely monitoring the patient ([0282]).
Regarding claim 4, Tran discloses The system of claim 1, wherein the instructions, when executed by the at least one processing device, further cause the system to: return the one or more clinical modules to the module store due to changes in the clinical condition vector calculated by the base module ([0064], the condition is analyzed and returned to store if not alerted or if condition is now better and alert isn’t needed anymore).
Regarding claim 5, Tran discloses The system of claim 1, wherein the data collected by the base module includes image data identifying equipment in operation around the patient, presence of medical personnel around the patient, and medical activities performed on the patient ([0136], [0178]).
Regarding claim 6, Tran discloses The system of claim 1, wherein the data collected by the base module includes vital sign measurements, medications, diagnoses, and chronic conditions of the patient (FIG. 1 and [0064], [0058] discussing monitoring patient with wearable, heart rate, ECG, blood oxygen, vital signs, etc.).
Regarding claim 7, Tran discloses The system of claim 1, wherein the clinical condition vector is a multi-vector score of clinical conditions observed by the base module ([0064] vital signs and combinations of vital signs and context is analyzed such that a multi-vector score is generated based on patient condition from multiple different sensors/cameras).
Regarding claim 8, Tran discloses A method of remotely monitoring a patient, the method comprising (Abstract and entire document):
performing a base module to remotely monitor the patient (FIG. 1 and [0064], [0058] discussing monitoring patient with wearable, heart rate, ECG, blood oxygen, vital signs, etc.);
generating a clinical condition vector using data collected by the base module ([0064], “The server 20 also executes one or more software modules to analyze data from the patient. A module 50 monitors the patient's vital signs such as ECG/EKG and generates warnings should problems occur.” Data is analyzed and condition is determined);
receiving one or more clinical modules from a module store, the one or more clinical modules received based on the clinical condition vector ([0064], “The server 20 also executes one or more software modules to analyze data from the patient. A module 50 monitors the patient's vital signs such as ECG/EKG and generates warnings should problems occur.” A warning or alert is a clinical module, based on the determined condition or clinical vector); and
performing the one or more clinical modules to remotely monitor the patient ([0056], “In one embodiment, appliances 8 monitor the patient and activates the camera 10 to capture and transmit video to an authorized third party for providing assistance should the appliance 8 detects that the user needs assistance or that an emergency had occurred.” And [0249 – 0250]).
Regarding claim 9, Tran discloses The method of claim 8, further comprising: activating one or imaging modalities based on the one or more clinical modules ([0056], “In one embodiment, appliances 8 monitor the patient and activates the camera 10 to capture and transmit video to an authorized third party for providing assistance should the appliance 8 detects that the user needs assistance or that an emergency had occurred.” And [0249 – 0250]).
Regarding claim 10, Tran discloses The method of claim 8, further comprising: simultaneously performing the one or more clinical modules while continuously performing the base module for remotely monitoring the patient ([0282]).
Regarding claim 11, Tran discloses The method of claim 8, further comprising: returning the one or more clinical modules to the module store due to changes in the clinical condition vector calculated by the base module ([0064], the condition is analyzed and returned to store if not alerted or if condition is now better and alert isn’t needed anymore).
Regarding claim 12, Tran discloses The method of claim 8, wherein the data collected by the base module includes image data identifying equipment in operation around the patient, presence of medical personnel around the patient, and medical activities performed on the patient ([0136], [0178]).
Regarding claim 13, Tran discloses The method of claim 8, wherein the data collected by the base module includes vital sign measurements, medications, diagnoses, and chronic conditions of the patient (FIG. 1 and [0064], [0058] discussing monitoring patient with wearable, heart rate, ECG, blood oxygen, vital signs, etc.).
Regarding claim 14, Tran discloses The method of claim 8, wherein the clinical condition vector is a multi-vector score of clinical conditions observed by the base module ([0064] vital signs and combinations of vital signs and context is analyzed such that a multi-vector score is generated based on patient condition from multiple different sensors/cameras).
Regarding claim 15, Tran discloses A system for providing clinical assessment of a patient, the system comprising (Abstract and entire document):
at least one processing device (FIG. 1 and [0011], [0302], [0306]); and
at least one computer readable data storage device storing software instructions that, when executed by the at least one processing device, cause the device to (FIG. 1 and [0011], [0058], [0064]):
receive a clinical condition vector, the clinical condition vector being a multi-vector score of clinical conditions observed by a base module (FIG. 1 and [0064], [0058] discussing monitoring patient with wearable, heart rate, ECG, blood oxygen, vital signs, etc. and see [0064] vital signs and combinations of vital signs and context is analyzed such that a multi-vector score is generated based on patient condition from multiple different sensors/cameras);
match one or more clinical modules to the clinical condition vector ([0064], “The server 20 also executes one or more software modules to analyze data from the patient. A module 50 monitors the patient's vital signs such as ECG/EKG and generates warnings should problems occur.” Data is analyzed and condition is determined and matched to a known condition); and
send the one or more clinical modules to a video analytics system for locally processing data inside a patient environment to remotely monitor the patient ([0056], “In one embodiment, appliances 8 monitor the patient and activates the camera 10 to capture and transmit video to an authorized third party for providing assistance should the appliance 8 detects that the user needs assistance or that an emergency had occurred.” And [0249 – 0250]).
Regarding claim 16, Tran discloses The system of claim 15, wherein the instructions, when executed by the at least one processing device, further cause the system to: display a prompt on a graphical user interface, the prompt including a first option to accept implantation of the one or more clinical modules, and a second option to decline implantation of the one or more clinical modules ([0255], [0056], [0282 – 0285], option is given to activate video data for remote monitoring or not, [0277]).
Regarding claim 18, Tran discloses The system of claim 15, wherein the one or more clinical modules activate one or imaging modalities on the video analytics system ([0056], “In one embodiment, appliances 8 monitor the patient and activates the camera 10 to capture and transmit video to an authorized third party for providing assistance should the appliance 8 detects that the user needs assistance or that an emergency had occurred.” And [0249 – 0250]).
Regarding claim 20, Tran discloses The system of claim 15, wherein the one or more clinical modules cause selection of a continuous mode or an interval mode for one or more sensors on a vital signs monitor capturing vital sign measurements of the patient ([0277], [0270]).
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Tran in view of Naveh et al. (US 2024/0008766 A1) (“Naveh”).
Regarding claim 17, Tran discloses The system of claim 15, Tran fails to disclose wherein the instructions, when executed by the at least one processing device, further cause the system to: display usage comparisons of the one or more clinical modules between a healthcare facility where the patient is admitted and a benchmark healthcare facility.
However, in the same field of endeavor, Naveh teaches wherein the instructions, when executed by the at least one processing device, further cause the system to: display usage comparisons of the one or more clinical modules between a healthcare facility where the patient is admitted and a benchmark healthcare facility ([0332 – [0345] comparing facility of patients, risk estimation, usage).
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 as taught by Tran to include wherein the instructions, when executed by the at least one processing device, further cause the system to: display usage comparisons of the one or more clinical modules between a healthcare facility where the patient is admitted and a benchmark healthcare facility as taught by Naveh to detect risk ([0332 – [0345]).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Tran in view of Tran in view of Tessmer et al. (US 2019/0083337 A1) (“Tessmer”).
Regarding claim 19, Tran discloses The system of claim 15, Tran fails to disclose wherein the one or more clinical modules cause selection of a triggering event for a bed exit alert on a bed where the patient is resting.
However, in the same field of endeavor, Tessmer teaches wherein the one or more clinical modules cause selection of a triggering event for a bed exit alert on a bed where the patient is resting ([0051] activate bed exit alarm).
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 as taught by Tran to include wherein the one or more clinical modules cause selection of a triggering event for a bed exit alert on a bed where the patient is resting as taught by Tessmer to alert caregiver ([0051]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Evanyk (US 2004/0225199 A1) (“Evanyk”) directed to a real time video image of an animate body, such as a patient/athlete, may be transmitted to a remotely located monitor for monitoring along with the transmitted physiological/biological patient parameters.
Ribble et al. (US 2020/0105422 A1) (“Ribble”) directed to An apparatus for remote at-home care of a patient is disclosed. The apparatus monitors a patient with a deployable sensor system and communicates the data sensed by the sensor system to a patient care hub located within a patient's home. A patient interface and a caregiver controller are in wireless communication with each other and the patient care hub. The patient care hub generates an alert(s) in view of the sensed data and wirelessly communicates the alert(s) to the patient interface and/or the caregiver controller.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH A TOMBERS whose telephone number is (571)272-6851. The examiner can normally be reached on M-TH 7:00-16:00, F 7:00-11:00(Eastern).
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, Robert Chen can be reached on 571-272-3672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see https://ppair-my.uspto.gov/pair/PrivatePair. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JOSEPH A TOMBERS/ Examiner, Art Unit 3791
Prosecution Insights