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 .
Response to Arguments
1. Applicant's arguments filed 02/05/2026 regarding the U.S.C. 101 rejections applied to claims 1, 3-7, 14-16 and 18-20 have been fully considered but they are not persuasive.
Regarding claims 1 and 14, The Applicant argues that the claims cannot be practically performed in the mind of a user. The Examiner respectfully disagrees. The claims as a whole teach receiving vital signs from a user, analyze these to determine if the patient is experiencing sepsis, and then if they are, outputting this data to be displayed visually. These steps are the same steps that a physician or medical personnel would take when making a diagnosis of a patient. For instance, a physician could look at vital signs, determine if the user is experiencing septic symptoms, and then notify the patient A physician would also be capable of updating/monitoring this in real time.
Regarding the additional elements, these do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The additional elements include sensors, processors, and a memory device. The Applicant has not indicated that these sensors, processors, or memory are made or used in such a way that they would be considered unconventional. As they are currently written, they well-understood, routine, conventional activity that is widely prevalent or common use in the relevant industry. The use of sensors/processors/etc. to gather and analyze patient information are well known in the art as disclosed by the following references: US 20190307405 A1 and US 20140288953 A1, If there is something about the Applicant’s sensors/processor that would make them unconventional, then they are advised to indicate this.
Regarding independent claim 8, the U.S.C. 101 rejection has been removed since the Applicant has amended to integrate the claims into practical application, that being adjusting the fluid input to the patient based on the sensor gathering and analysis.
Applicant's arguments filed 02/05/2026 regarding the U.S.C. 102 rejections applied to claims 1, 3-11, 13-16 and 18-20 have been fully considered but they are not persuasive.
The Applicant argues that the art of Terry does not teach “a notification system operable to display a first visual indication showing if the patient has risk for sepsis or has been diagnosed with sepsis, the controller further operable to monitor and update the first visual indication in real time until administration of a sepsis protocol is completed.” The Examiner respectfully disagrees. Par. 0095 teaches “In each of these cases of increasing risk score, the analytics engine 20 initiates an alert to one or more caregivers assigned to the patient in some embodiments. Such alerts may be sent to a mobile device (e.g., pager, personal digital assistant (PDA), smart phone, or tablet computer) carried by the respective one or more caregivers. Such alerts may also be displayed on graphical displays 36 and dome lights 38 of system 10.” Thus teaching the portion about providing a visual indication. Par. 0135 then goes on to teach “The risk profiles for each patient are updated in substantially real time by the analytics engine as the incoming data changes.”, thus teaching the second limitation. Therefore, the rejection still stands.
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.
2. Claims 1, 3-7, 14-16 and 18-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The independent claims 1 and 14 recite a method for determining if a patient is at risk for sepsis. The limitation, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components. For example, gathering sensor data and patient support data to determine if a patient is at risk for sepsis can simply be done by looking at the data on a printout or screen and then making a mental determination. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. This judicial exception is not integrated into a practical application.
The components are recited at a high-level of generality such that it amounts no more than any structure that can gather and analyze data. Further, the use of sensors, processors/memory devices, and a patient support/mattress in the claims, are merely insignificant extra-solution activity of data gathering. 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 is directed to an abstract idea.
The additional elements, such as the sensors and patient supports to gather patient data as well as processors/memories to analyze data, while being mere structures for data gathering are also well-understood, routine, conventional activity that is widely prevalent or common use in the relevant industry. The use of sensors/processors/etc. to gather and analyze patient information are well known in the art as disclosed by the following references: US 20190307405 A1 and US 20140288953 A1. Well-understood, routine and conventional activity cannot be significantly more than the abstract idea itself. The claims are not patent eligible.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
3. Claim(s) 1, 3-11, 13-16, and 18-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Terry (US 20190307405 A1).
In regards to claim 1, Terry discloses a patient support apparatus (Abstract) comprising:
a deck supported by a frame and siderails configurable to block egress of a patient (Par. 0074 teaches a patient support deck)
a sensor providing a first signal indicative of a vital sign of a patient positioned on the patient support apparatus (Par. 0075 teaches a sensor integrated into the patient support [14] to sense vital signals);
a point of care device providing a second signal (Par. 0078 teaches the use of a monitor [18] like an ECG, EEG, of EKG etc. that can take in second signals); and
a controller coupled to the sensor and the point of care device, including a processor and a memory device (Par. 0085 teaches a gateway/router than takes in the sensor and point of care data),
the memory device including instructions that, when executed, cause the controller to receive the first signal from the sensor and the second signal from the point of care device, analyze the first and the second signals to determine data indicative of sepsis (Par. 0087 teaches the data from the first and second signals is then used to assess the patients risk of developing sepsis),
compare the data indicative of sepsis to pre-established acceptable limits, and if the patient is assessed to have a risk for sepsis or has been diagnosed with sepsis, output a signal to a notification system operable to display a first visual indication showing if the patient has risk for sepsis or has been diagnosed with sepsis (Par. 0087-0088 teach developing a risk score for the patient and if the score is out of normal then an alert can be transmitted. Par. 0095 teaches a risk score can be displayed on an interface),
the controller further operable to monitor and update the first visual indication in real time until administration of a sepsis protocol is completed (Par. 0135 teaches making real time updates).
In regards to claim 3, Terry discloses the patient support apparatus of claim 1, wherein the point of care device is a peripheral device or a connected device (Par. 0078 teaches the point of care device can be a monitor [18]; i.e. connected device).
In regards to claim 4, Terry discloses the patient support apparatus of claim 1, wherein the point of care device is a cell counter or a cell quality monitor (Par. 0142 teaches using a cel count.)
In regards to claim 5, Terry discloses the patient support apparatus of claim 1, wherein the point of care device is a blood test module and comprises disposable tools for testing blood cell count or blood cell quality (Par. 0115 teaches a blood test system to check CBC).
In regards to claim 6, Terry discloses the patient support apparatus of claim 1, wherein the controller is configured to communicate with an external nurse call station (Par. 0104 taches communicating with nurse call systems).
In regards to claim 7, Terry discloses the patient support apparatus of claim 1, wherein the controller is configured to communicate with an electronic medical record system to receive information from the electronic medical record system indicative of a medical history of a patient supported on the patient support apparatus (Par. 0110 teaches the system in communication with medical health records to receive that information).
In regards to claim 8, Terry discloses a patient support apparatus (Abstract) comprising:
a deck supported by a frame and siderails configurable to block egress of a patient (Par. 0074 teaches a patient support deck),
a sensor providing a first signal indicative of a first vital sign of a patient supported on the patient support apparatus (Par. 0075 teaches a sensor integrated into the patient support [14] to sense vital signals);
a point of care device providing a second signal indicative of a cardiac output of the patient (Par. 0078 teaches the use of a monitor [18] like an ECG, EEG, of EKG etc. that can take in second signals); and
a controller coupled to the sensor and the point of care device, and including a processor and a memory device (Par. 0085 teaches a gateway/router than takes in the sensor and point of care data),
the memory device including instructions that, when executed, cause the controller to receive the first and second signals, calculate a sepsis risk severity and an optimal fluid challenge amount based on the first and second signals (Par. 0087 teaches the data from the first and second signals is then used to assess the patient’s risk of developing sepsis; Par. 0146 also teaches determining optimal fluid rates from a patient).
the controller operable to automatically adjust a patient infusion system to provide a fluid input to the patient, and provide a first visual indication on a notification system to indicate fluid responsiveness of the patient after fluid infusion (Par. 0096 teaches using an infusion pump can that automatically monitor and deliver fluid).
In regards to claim 9, Terry discloses the patient support apparatus of claim 8, wherein the controller further receives and analyzes information from an electronic medical record storing patient information for the patient (Par. 0110 teaches the system in communication with medical health records to receive that information).
In regards to claim 10, Terry discloses the patient support apparatus of claim 8, wherein the apparatus further comprises the notification system responding to the signal from the controller to provide a second visual indication that shows that the patient has risk for sepsis or has been diagnosed with sepsis (Par. 0095 teaches a risk score can be displayed on an interface).
In regards to claim 11, Terry discloses the patient support apparatus of claim 8, wherein the apparatus further comprises the notification system responding to the signal from the controller to provide a second visual indication that shows that the patient has risk for sepsis or has been diagnosed with sepsis, and a third visual indication that shows an amount of fluid needed for fluid administration (Par. 0087-0088 teach developing a risk score for the patient. Par. 0050 teaches the patient can be treated with fluids and medical records can be used to determine the amount of fluids/medications needed.
In regards to claim 13, Terry discloses the patient support apparatus of claim 11, wherein the first visual indication shows a sepsis graph indicating a rate of improvement in the patient after fluid infusion (Par. 088 teaches graphical displays that can show using lights which level of risk the patient is ranging from green to red; i.e. if the patient is getting better the light would go from red to yellow to green).
In regards to claim 14, Terry discloses a method of predicting sepsis in a patient on a patient support apparatus (Abstract) comprising an inflatable mattress (Par. 0077 teaches a mattress), the method comprising the steps of:
monitoring a first signal from a sensor, wherein the first signal is indicative of a vital sign of the patient (Par. 0075 teaches a sensor integrated into the patient support [14] to sense vital signals);
monitoring a second signal from a point of care device (Par. 0078 teaches the use of a monitor [18] like an ECG, EEG, of EKG etc. that can take in second signals);
processing the first signal and the second signal to determine data indicative of sepsis (Par. 0087 teaches the data from the first and second signals is then used to assess the patient’s risk of developing sepsis);
comparing the data indicative of sepsis to pre-established acceptable limits to assess if the patient has sepsis or has a risk for sepsis; and outputting a command signal to indicate if the patient has sepsis or has a risk for sepsis (Par. 0087-0088 teach developing a risk score for the patient and if the score is out of normal then an alert can be transmitted),
display a first visual indication on the notification system showing if the patient has risk for sepsis or has been diagnosed with sepsis, and updating the first visual indication in real time until administration of a sepsis protocol is completed (Par. 0095 and 0135 teach a visual indication that can be updated in real time)
In regards to claim 15, Terry discloses the method of claim 14, wherein processing the first signal and the second signal to determine data indicative of sepsis comprises a controller analyzing the first and the second signals to determine data indicative of sepsis and comparing the data indicative of sepsis to pre-established acceptable limits (Par. 0085 teaches a gateway/router that can transmit the data to an analytics machine to determine sepsis risk).
In regards to claim 16, Terry discloses the method of claim 15, wherein processing the first signal and the second signal further comprises the controller receiving and analyzing information from an electronic medical record storing patient information for the patient Par. 0110 teaches the system in communication with medical health records to receive that information).
In regards to claims 18 and 19, Terry discloses the method of claim 14, wherein the method further comprises the notification system responding to the signal from the controller to provide a second visual indication that shows if the patient needs fluid administration (Par. 0146 and 0096)
In regards to claim 20, Terry discloses the method of claim 19, wherein the method further comprises the controller communicating with a patient infusion system to automatically adjust fluid input to the patient (Par. 0096).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SKYLAR LINDSEY CHRISTIANSON whose telephone number is (571)272-0533. The examiner can normally be reached Monday-Friday, 7:30-5:30 EST.
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, Niketa Patel can be reached at (571) 272-4156. 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.
/S.L.C./Examiner, Art Unit 3792
/NIKETA PATEL/Supervisory Patent Examiner, Art Unit 3792
Prosecution Insights