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 .
DETAILED ACTION
Status of the Application
Claims 1-37 are currently pending in this case and have been examined and addressed below. This communication is a Non-Final Rejection in response to the Amendment to the Claims filed on 09/20/2024.
Claims 1-17 are canceled and not considered at this time.
Claims 18-37 are newly added.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 09/10/2024 and 09/11/2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. However, in view of the excessive volume of references provided, Examiner was only able to give a cursory review of the documents.
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 18-37 are rejected because the claimed invention is directed to an abstract idea without significantly more.
Step 1
Claims 18-37 fall within the statutory category of an apparatus or system.
Step 2A, Prong One
As per Claim 18, the limitations of receiving a plurality of patient inputs to configure a plurality of alarm threshold levels for one of the physiological parameters and a plurality of alerts, wherein different alerts are transmitted for the plurality of alarm threshold levels; and in response to one of the plurality of alarm threshold levels being exceeded by the one or more physiological parameter values, transmit a corresponding alert, under its broadest reasonable interpretation, covers managing personal behaviors and personal interactions. If a claim limitation, under its broadest reasonable interpretation, covers managing personal behaviors and personal interactions, then it falls within the “certain methods of organizing human activity” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
Step 2A, Prong Two
The judicial exception is not integrated into a practical application because the additional elements and combination of additional elements do not impose meaningful limits on the judicial exception. In particular, the claim recites the additional elements – a wearable patient sensor device configured to measure physiological parameters from a patient, a patient device in communication with the wearable patient sensor device comprising a memory device configured to store instructions, and a hardware processor to execute instructions. The wearable patient sensor device in these steps is recited at a high-level of generality, such that it amounts to no more than mere instructions to apply the exception using a generic computer component. The wearable sensor device recites measure physiological parameters which is the sensor device used for its ordinary purpose, which amounts to mere instructions to apply the exception, as per MPEP 2106.05(f)(2). The patient device in communication with the wearable patient sensor device comprising a memory device and hardware processor is recited at a high level of generality, such that it amounts to no more than mere instructions to apply the exception. Accordingly, these additional elements do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claim also recites the additional elements of measuring physiological parameters from a patient, storing instructions in memory, receiving physiological parameter values generated by the wearable sensor device, and outputting a plurality of user interfaces for receiving data. The storing of instructions in memory amounts to mere instructions to apply the exception, as per MPEP 2106.05(f)(2) in which the courts have found the use of a computer in its ordinary capacity for tasks such as storing data to be mere instructions to apply the exception. The claim also recites the additional element of outputting a plurality of user interfaces for receiving data which amounts to mere instructions to apply the exception similar to MPEP 2106.05(f)(2) remotely accessing user-specific information through a mobile interface and pointers to retrieve the information without any description of how the mobile interface and pointers accomplish the result of retrieving previously inaccessible information, Intellectual Ventures v. Erie Indem. Co., 850 F.3d 1315, 1331, 121 USPQ2d 1928, 1939 (Fed. Cir. 2017). The steps of measuring physiological parameters from a patient and receiving physiological parameter values generated by the wearable sensor device amount to insignificant extra-solution activity because they are mere data gathering. Measuring physiological parameters from a patient is mere data gathering similar to performing clinical tests on individuals, as per MPEP 2106.05(g)(3). Receiving physiological parameter values amounts to mere data gathering necessary for the abstract idea which amounts to insignificant extra-solution activity, as per MPEP 2106.05(g)(3). Because the additional elements do not impose meaningful limitations on the judicial exception, the claim is directed to an abstract idea.
Step 2B
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements when considered both individually and as an ordered combination do not amount to significantly more than the abstract idea. As discussed above with the respect to integration of the abstract idea into a practical application, the additional element of a wearable patient sensor device configured to measure physiological parameters from a patient, a patient device in communication with the wearable patient sensor device comprising a memory device configured to store instructions, and a hardware processor to perform the method of the invention amounts to no more than mere instructions to apply the exception using a generic computing component. The wearable patient sensor device is recited at a high level of generality and does not specify a particular or specific sensor and is therefore a general purpose sensor device. The patient device is also not specified or described by any particular device. The specification describes a system including a memory device and hardware processor, which Examiner interprets to be the patient device (Specification [0010]) which is not specified beyond any general purpose computer. The claim also recites the additional elements of storing instructions in memory and outputting a plurality of user interfaces for receiving data which are found to be mere instructions to apply the exception. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. The claim also includes the additional elements of measuring physiological parameters from a patient which is well-understood, routine, and conventional activity in life sciences arts, similar to determining the level of a biomarker in blood by any means, Mayo, 566 U.S. at 79, 101 USPQ2d at 1968; Cleveland Clinic Foundation v. True Health Diagnostics, LLC, 859 F.3d 1352, 1362, 123 USPQ2d 1081, 1088 (Fed. Cir. 2017), as per MPEP 2106.05(d)(II)(i). The claim also recites the additional element of receiving physiological parameter values generated by the wearable sensor device, which is well-understood, routine and conventional computer functions in the field of data management because they are claimed at a high level of generality and include receiving or transmitting data, which has been found to be well-understood, routine and conventional computer functions by the Court (MPEP 2106.05(d)(II)(i) Receiving or transmitting data over a network, e.g., using the Internet to gather data, Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information); TLI Communications LLC v. AV Auto. LLC, 823 F.3d 607, 610, 118 USPQ2d 1744, 1745 (Fed. Cir. 2016) (using a telephone for image transmission); OIP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015) (sending messages over a network); buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and sends information over a network); but see DDR Holdings, LLC v. Hotels.com, L.P., 773 F.3d 1245, 1258, 113 USPQ2d 1097, 1106 (Fed. Cir. 2014) ("Unlike the claims in Ultramercial, the claims at issue here specify how interactions with the Internet are manipulated to yield a desired result‐‐a result that overrides the routine and conventional sequence of events ordinarily triggered by the click of a hyperlink." (emphasis added). Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of the computer or improves another technology. The claim does not amount to significantly more than the underlying abstract idea.
Dependent Claims
Dependent Claims 19-37 add further limitations which are also directed to an abstract idea. Claims 19-25, 27, 30-31, 34, and 36-37 include limitations which further serve to specify or limit the elements of the independent claim and are therefore directed to the same abstract idea as Claim 18. Claim 26, 28, 32, 33 include further description of the user interfaces and are therefore directed to the same abstract idea as Claim 18. Claim 29 includes receiving patient input of an address which is an additional element that amounts to mere data gathering which is insignificant extra-solution activity that does not integrate into a practical application or provide significantly more for the same reasons as the independent claim. Claim 35 includes outputting a recent events element summarizing a number of events at alarm threshold levels which describes mere data outputting, which is insignificant extra-solution activity that does not integrate into a practical application or provide significantly more for the same reasons as the independent claim. Because the additional elements do not impose meaningful limitations on the judicial exception and the additional elements are well-understood, routine and conventional functionalities in the art, the claims are directed to an abstract idea and are not patent eligible.
Claim Rejections - 35 USC § 103
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 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.
Claims 18-20, 23-26, and 30-37 are rejected under 35 U.S.C. 103 as being unpatentable over Sanyal et al. (US 2017/0372026 A1), hereinafter Sanyal, in view of Sampath et al. (US 2018/0174680 A1), hereinafter Sampath.
As per Claim 18, Sanyal discloses a system for patient care and monitoring, the system comprising:
a wearable patient sensor device configured to measure physiological parameters from a patient ([0018] and Table 1 wearable sensors to monitor physiological parameters of a patient);
a patient device in communication with the wearable patient sensor device ([0015] mobile or portable device in communication with the sensors), the patient device comprising:
a memory device configured to store instructions; and a hardware processor ([0019] portable device houses an application, i.e. instructions, where the portable device is a smart phone including a processor) configured to execute instructions to:
receive one or more physiological parameter values generated by the wearable patient sensor device ([0024] sensor performs measurements of the parameter and data is processed and transmitted to mobile device);
output a plurality of user interfaces ([0024] user interface of the mobile device receives the sensor data, [0033] display of the smartphone allows for visualization of the data/results) configured to receive a plurality of patient inputs ([0060] user interface for user to enter personal information and requests) wherein different alerts are transmitted for the plurality of alarm threshold levels ([0054-0058] alerts with different colors for different levels normal, critical, and life-threatening); and
in response to one of the plurality of alarm threshold levels being exceeded by the one or more physiological parameter values, transmit a corresponding alert ([0004] based on comparison of physiological parameter to bounds, provide alerts, [0029] sending notifications when physiological data values are within bounds of normal, critical, or life-threatening for the parameter).
However, Sanyal may not explicitly disclose the following which is taught by Sampath: configure a plurality of alarm threshold levels for one of the physiological parameters and a plurality of alerts ([0200] user input/interface for altering patient settings including alarm types and physiological alarm limits/thresholds).
Therefore, it would have been obvious to a person of ordinary skill in the art before the filing of the current application to combine the known concept of configuring alarm threshold levels for physiological parameters and plurality of alerts from Sampath with the known system of monitoring a physiological parameter and sending alerts when the values exceed one of a plurality of threshold levels from Sanyal in order to determine whether to increase the level of medical care given to a patient based on the determined patient condition (Sampath [0003]).
As per Claim 19, Sanyal and Sampath discloses the system of Claim 18. Sanyal also teaches the one of the physiological parameters comprises blood oxygen saturation or SpO2 (see Fig. 1 parameter including oxygen saturation; [0002]/Table 1 parameters measured include oxygen saturation, SpO2).
As per Claim 20, Sanyal and Sampath discloses the system of Claim 18. Sanyal also teaches a portion of the wearable patient sensor device is configured to be attached to a wrist of the patient ([0020] sensor worn on the wrist, [0021] sensor is wrist-mounted).
As per Claim 23, Sanyal and Sampath discloses the system of Claim 18. Sanyal also teaches the patient device is in wireless communication with the wearable patient sensor device ([0003] multiple components wirelessly communicating with one another, [0015] mobile or portable device in communication with the sensors, see Fig. 6 wireless connection between sensors and mobile device/smartphone).
As per Claim 24, Sanyal and Sampath discloses the system of Claim 18. Sanyal also teaches the plurality of alarm threshold levels comprises an emergency level ([0029] ranges for parameter values include life-threatening).
As per Claim 25, Sanyal and Sampath discloses the system of Claim 24. Sanyal also teaches the alert corresponding to the emergency level comprises notifying an emergency contact or emergency medical responders ([0029] ranges for parameter values include life-threatening, when life threatening bounds have been exceeded, the mobile device will initiate a call to 911, i.e. emergency medical responders, [0030] alerts sent to emergency services, see also [0058-0059]).
As per Claim 26, Sanyal and Sampath discloses the system of Claim 25. Sanyal may not explicitly disclose the following which is taught by Sampath: the plurality of user interfaces are further configured to allow the patient to set an amount of time after the emergency level has been exceeded before notifying the emergency contact or emergency medical responders ([0403] configuring the patient monitor to wait until a predetermined alarm notification delay time has elapsed before transmitting a notification to a clinician, i.e. emergency responder, [0226] configuration preferences for patient monitoring device include settings such as parameter alarm limits, see Fig. 9 which includes a user interface for configuration settings).
Therefore, it would have been obvious to a person of ordinary skill in the art before the filing of the current application to combine the known concept of a user interface for configuring alarm settings such as alarm delay time from Sampath with the known system of monitoring a physiological parameter and sending alerts when the values exceed one of a plurality of threshold levels from Sanyal in order to determine whether to increase the level of medical care given to a patient based on the determined patient condition (Sampath [0003]).
As per Claim 30, Sanyal and Sampath discloses the system of Claim 18. Sanyal also teaches the plurality of alarm threshold levels comprises a warning level ([0056-0057] alert for when the vital parameter exceeds the normal bounds and is within a critical range).
As per Claim 31, Sanyal and Sampath discloses the system of Claim 30. Sanyal also teaches the alert corresponding to the warning level comprises outputting a warning message to the patient on a display of the patient device ([0056-0057] alert for when the vital parameter exceeds the normal bounds and is within a critical range, the alert outputting a yellow color to the user on the mobile device, [0029] push notifications sent to mobile device as text or other symbols/codes to indicate critical bounds with an orange code).
As per Claim 32, Sanyal and Sampath discloses the system of Claim 31. Sampath also teaches the plurality of user interfaces are further configured to allow the patient to set an amount of time after the warning level has been exceeded before displaying the warning message ([0403] configuring a wait or delay time to elapse from the time of the alarm condition until the alarm is transmitted).
Therefore, it would have been obvious to a person of ordinary skill in the art before the filing of the current application to combine the known concept of configuring an amount of time to wait before sending alarm from Sampath with the known system of monitoring a physiological parameter and sending alerts when the values exceed one of a plurality of threshold levels from Sanyal in order to reduce the number of false positive alarms which clinicians must respond to (Sampath [0404]).
As per Claim 33, Sanyal and Sampath discloses the system of Claim 18. Sanyal also teaches the plurality of user interfaces are further configured to allow the patient to set a different parameter value for each of the plurality of alarm threshold levels ([0036] parameter ranges are customized for the patient).
As per Claim 34, Sanyal and Sampath discloses the system of Claim 18. Sanyal also teaches the plurality of alarm threshold levels comprises a good range, a caution range, a serious range, and/or a critical range (see Fig. 2/[0004] ranges for alarm thresholds are normal, critical, and life-threatening).
As per Claim 35, Sanyal and Sampath discloses the system of Claim 34. Sanyal also teaches the hardware processor is configured to execute further instructions to output for display a recent events element summarizing a number of events at one or more of the plurality of alarm threshold levels ([0040] provide long-term trends for vital parameters consisting of parameters measured over time and displayed to the mobile device).
As per Claim 36, Sanyal and Sampath discloses the system of Claim 18. Sampath also teaches the hardware processor is configured to execute further instructions to transmit an alert related to low sensor battery ([0082] alarms for low battery for the pulse oximeter sensor; [0075] alerts transmitted to end users over shared network).
Therefore, it would have been obvious to a person of ordinary skill in the art before the filing of the current application to combine the known concept of sending a low battery alarm from Sampath with the known system of monitoring a physiological parameter and sending alerts when the values exceed one of a plurality of threshold levels from Sanyal in order to determine whether to increase the level of medical care given to a patient based on the determined patient condition (Sampath [0003]).
As per Claim 37, Sanyal and Sampath discloses the system of Claim 18. Sampath also teaches the hardware processor is configured to execute further instructions to transmit a sensor-off alert ([0082] alarms for sensor off patient; [0075] alerts transmitted to end users over shared network).
Therefore, it would have been obvious to a person of ordinary skill in the art before the filing of the current application to combine the known concept of sending a sensor-off alert from Sampath with the known system of monitoring a physiological parameter and sending alerts when the values exceed one of a plurality of threshold levels from Sanyal in order to determine whether to increase the level of medical care given to a patient based on the determined patient condition (Sampath [0003]).
Claims 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Sanyal (US 2017/0372026 A1), in view of Sampath (US 2018/0174680 A1), in view of Haahr et al. (Rasmus G. Haahr, Sune B. Duun, Mette H. Toft, Bo Belhage, Jan Larsen, Karen Birkelund, Erik V. Thomsen; An Electronic Patch for Wearable Health Monitoring by Reflectance Pulse Oximetry; February 2012; IEEE Transactions on Biomedical Circuits and Systems, Vol. 6, No. 1, pp 45-53), hereinafter Haahr.
As per Claim 21, Sanyal and Sampath discloses the system of Claim 18. Sanyal also teaches the wearable patient sensor device comprises a fingertip pulse oximeter ([0020-0021] sensors worn on locations including fingertip).
However, Sanyal and Sampath may not explicitly disclose the following which is taught by Haahr: the fingertip sensor is a pulse oximeter (Page 49 Col. 2 oxygen saturation measured using pulse oximeter places on the third digit of the left hand).
Therefore, it would have been obvious to a person of ordinary skill in the art before the filing of the current application to combine the known concept of measuring patient data with a fingertip pulse oximeter from Haahr with the known system of monitoring a physiological parameter and sending alerts when the values exceed one of a plurality of threshold levels from Sanyal and Sampath in order to allow for monitoring that can be worn at all times and allows for improved movement of the patient (Haahr Page 45 Col. 2).
As per Claim 22, Sanyal and Sampath discloses the system of Claim 18. However, Sanyal and Sampath may not explicitly disclose the following which is taught by Haahr: the wearable patient sensor device comprises a disposable device coupled to a reusable device (Page 48 E. Packaging patch has reusable and disposable parts which are snapped together).
Therefore, it would have been obvious to a person of ordinary skill in the art before the filing of the current application to combine the known concept of a wearable sensor which has disposable and reusable portions from Haahr with the known system of monitoring a physiological parameter and sending alerts when the values exceed one of a plurality of threshold levels from Sanyal and Sampath in order to allow for monitoring that can be worn at all times and allows for improved movement of the patient (Haahr Page 45 Col. 2).
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Sanyal (US 2017/0372026 A1), in view of Sampath (US 2018/0174680 A1), in view of Hossain (M. A. Hossain & S. K. Ray, "A Technology Assisted Framework for Medical Emergencies Involving Formal and Informal Caregivers," 2018 IEEE Intl Conf on Parallel & Dist'd Processing w/Applications, Ubiquitous Computing & Comms, etc., Australia, 2018, pp. 1064-1070), hereinafter Hossain.
As per Claim 27, Sanyal and Sampath discloses the system of Claim 26. Sanyal and Sampath may not explicitly disclose the following which is taught by Hossain: the amount of time after the emergency level has been exceeded before notifying the emergency contact is different from the amount of time after the emergency level has been exceeded before notifying the emergency medical responders (Page 1065 Introduction an escalation process, Page 1066 III. TAME Framework leveraging information carer such as family, friends to respond to medical emergency situation, Page 1068 broadcast low severity emergencies to informal caregivers, use a waiting timer to keep track of response from informal caregiver and when no response, i.e. a different amount of time, escalate to a formal caregiver response, see Algorithm 1 escalation process where a second wait time is the different amount of time).
Therefore, it would have been obvious to a person of ordinary skill in the art before the filing of the current application to combine the known concept of different wait times for sending alerts from Hossain with the known system of monitoring a physiological parameter and sending alerts when the values exceed one of a plurality of threshold levels from Sanyal and Sampath in order to provide prompt medical care when required in emergency situations (Hossain Page1064 Abstract).
Claim 28-29 are rejected under 35 U.S.C. 103 as being unpatentable over Sanyal (US 2017/0372026 A1), in view of Sampath (US 2018/0174680 A1), in view of Zhang (WO 2015/143085 A1), hereinafter Zhang.
As per Claim 28, Sanyal and Sampath discloses the system of Claim 25. Sanyal and Sampath may not explicitly disclose the following which is taught by Zhang: the plurality of user interfaces are further configured to allow the patient to configure repeat notifications to the emergency contact ([0057] monitoring device is configured to repeatedly send alert notification, [0120] user interface provides functionality of setting the monitoring device).
Therefore, it would have been obvious to a person of ordinary skill in the art before the filing of the current application to combine the known concept of a user interface for configuring repeat notifications from Zhang with the known system of monitoring a physiological parameter and sending alerts when the values exceed one of a plurality of threshold levels from Sanyal and Sampath in order to ensure that the alert is received by the recipient (Zhang [0057]).
As per Claim 29, Sanyal and Sampath discloses the system of Claim 25. Sanyal and Sampath may not explicitly disclose the following which is taught by Zhang: hardware processor is configured to execute further instructions to receive a patient input to set an address that the emergency medical responders respond to in response to being notified of the emergency level ([0173] patient medical information includes physical address for the patient, [0211] configuration data received at a graphical user interface on user device including medical-related device, [0244-0245] users can input medical-related data into user device).
Therefore, it would have been obvious to a person of ordinary skill in the art before the filing of the current application to combine the known concept of setting an address for the patient from Zhang with the known system of monitoring a physiological parameter and sending alerts when the values exceed one of a plurality of threshold levels from Sanyal and Sampath in order to more quickly respond to individuals suffering from emergency medical situations (Zhang [0002]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Ahmed et al. (US 2019/0320988 A1) teaches an alarm notification system to send alarms when patient who is being monitored has data which has passed a threshold value.
Otavio (US 2018/0342139 A1) teaches an alert system for prioritizing when to send alerts.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Evangeline Barr whose telephone number is (571)272-0369. The examiner can normally be reached Monday to Friday 8:00 am to 4:00 pm.
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, Fonya Long can be reached at 571-270-5096. 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.
/EVANGELINE BARR/Primary Examiner, Art Unit 3682