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
1. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 07/30/2026 has been entered.
Response to Arguments
2. Applicant's arguments filed 07/21/2026 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, including the present amendments, teach receiving vital signs from a user, analyzing these signals to determine if the patient is experiencing sepsis, and then, if they are, outputting this data to be displayed visually – this visual representation showing the status of applied sepsis administration. 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 what phase of treatment they are in. A physician would also be capable of updating/monitoring this in real time or continuously.
Further, there is no actual treatment being claimed that would integrate these claims into practical application. If there was an actual treatment step (i.e., the data is being used to adjust fluid, as disclosed in claim 8), then that would integrate the concept into practical application. The current amendment would not be enough to integrate the claims into practical application since there is not an actual step about administering treatment or controlling treatments based on the predicted diagnosis/treatment plan. The Examiner points to the MPEP 2106.04(d)(2).
Examiners should keep in mind that in order to qualify as a "treatment" or "prophylaxis" limitation for purposes of this consideration, the claim limitation in question must affirmatively recite an action that effects a particular treatment or prophylaxis for a disease or medical condition. An example of such a limitation is a step of "administering amazonic acid to a patient" or a step of "administering a course of plasmapheresis to a patient." If the limitation does not actually provide a treatment or prophylaxis, e.g., it is merely an intended use of the claimed invention or a field of use limitation, then it cannot integrate a judicial exception under the "treatment or prophylaxis" consideration. For example, a step of "prescribing a topical steroid to a patient with eczema" is not a positive limitation because it does not require that the steroid actually be used by or on the patient, and a recitation that a claimed product is a "pharmaceutical composition" or that a "feed dispenser is operable to dispense a mineral supplement" are not affirmative limitations because they are merely indicating how the claimed invention might be used.
Based on the bolded portion of the recited passage, the step of predicting sepsis and displaying how far into treatment a patient is is not enough to integrate a judicial exception into practical application. The rejection still stands.
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, a memory device, and a deck supported by a frame. The Applicant has not indicated that these sensors, processors, decks, 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.
Applicant’s arguments, filed 07/21/2026, with respect to the rejection(s) of claim(s) 1, 3-7, 14-16 and 18-20 under U.S.C. 102 (a)(1) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Fitzgibbons (US 20200275877 A1).
Regarding the Applicant’s arguments that the art of Terry does not teach “a point of care device coupled to the patient support apparatus and providing a second signal indicative of a white blood cell count of the patient…”, the Examiner respectfully disagrees and points to Par. 0045 and 0142 of Terry. These paragraphs teach “In some embodiments, the method of the sixth aspect further may include receiving at the analytics engine laboratory data of the patient and using the laboratory data in connection with calculating the risk score. Optionally, the laboratory data may include data that may pertain to one or more of the following… normal white blood count (WBC) with greater than 10% neutrophils … partial thromboplastin time (PTT), or white blood cell count.” This clearly indicates that white blood cell count can be a signal sent to the system.
Applicant’s arguments, filed 07/21/2026, with respect to the rejection(s) of claim(s) 8-11 and 13 under U.S.C. 102(a)(1) have been fully considered but are not persuasive. The Applicant argues that the art of Terry does not teach automatically adjusting a patient infusion system to provide a fluid input to the patient. The Examiner respectfully disagrees. Par. 0096 explcity teaches “Thus, in some embodiments, a message received by one or more of sources 12 from analytics engine 20 results in a risk reduction protocol or function of the source 12 being activated automatically (e.g., an alternating pressure function of a mattress being turned on automatically or an infusion pump for delivery of IV antibiotics being turned on automatically or a bed exit/patient position monitoring function of a bed being turned on automatically). 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.
3. 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.
4. Claim(s) 8-11 and 13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Terry (US 20190307405 A1).
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).
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.
5. Claim(s) 1, 3-7, 14-16, and 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Terry (US 20190307405 A1) in view of Fitzgibbons (US 20200275877 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 coupled to the patient support apparatus and providing a second signal indicative of a white blood cell count of the patient (Par. 0045 teaches there can be a medical engine laboratory, i.e. point of care device, that can provide data such as white blood cell count); and
a controller located on the patient support apparatus and 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).
While Terry does teach a monitor/display system to indicate that a user is experiencing sepsis/what the user’s risk score is for developing sepsis, they do not teach monitoring a status of sepsis protocol administration and cause the sepsis notification system to provide an indication of the status of the sepsis protocol administration, wherein the sepsis notification system is communicatively coupled to the controller and comprises an indicator panel coupled to the patient support apparatus and configured to display the first visual indication, wherein the indicator panel is viewable from a position adjacent to the patient support apparatus.
However, in the same field of endeavor, Fitzgibbons teaches a patient support system for determining if a user is experiencing sepsis and providing treatment (Abstract and Par. 0002) wherein there is a display, that is viewable by a patient (see Fig 1) and that can show updates on the patient’s care protocols/treatment steps (Par. 0068 and Fig 5) in order to help the user determine what actions are needed for compliance with the sepsis protocols (Par. 0068).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have taken the teachings of Terry and modified them by having the system display the status of the sepsis protocol administration, as taught and suggested by Fitzgibbons, in order to help the user determine what actions are needed for compliance with the sepsis protocols (Par. 0068 of Fitzgibbons).
In regards to claim 3, the combined teachings of Terry and Fitzgibbons as applied to claim 1 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 or Par. 0045 teaches it can be a laboratory that).
In regards to claim 4, the combined teachings of Terry and Fitzgibbons as applied to claim 1discloses the patient support apparatus of claim 1, wherein the point of care device is a cell quality monitor (Par. 0045 and 0142 of Terry.)
In regards to claim 5, the combined teachings of Terry and Fitzgibbons as applied to claim 1 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 of Terry teaches a blood test system to check CBC).
In regards to claim 6, the combined teachings of Terry and Fitzgibbons as applied to claim 1 discloses the patient support apparatus of claim 1, wherein the controller is configured to communicate with an external nurse call station (Par. 0104 pf Terry taches communicating with nurse call systems).
In regards to claim 7, the combined teachings of Terry and Fitzgibbons as applied to claim 1 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 of Terry teaches the system in communication with medical health records to receive that information).
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 coupled to the patient care device, 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 coupled to the patient support apparatus and providing a second signal indicative of a white blood cell count of the patient (Par. 0045 teaches there can be a medical engine laboratory, i.e. point of care device, that can provide data such as white blood cell count); and
processing the first signal and the second signal by a controller located on the patient support apparatus and coupled to the sensor and the point of care device 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).
While Terry does teach a monitor/display system to indicate that a user is experiencing sepsis/what the user’s risk score is for developing sepsis, they do not teach monitoring a status of sepsis protocol administration and cause the sepsis notification system to provide an indication of the status of the sepsis protocol administration, wherein the sepsis notification system is communicatively coupled to the controller and comprises an indicator panel coupled to the patient support apparatus and configured to display the first visual indication, wherein the indicator panel is viewable from a position adjacent to the patient support apparatus.
However, in the same field of endeavor, Fitzgibbons teaches a patient support system for determining if a user is experiencing sepsis and providing treatment (Abstract and Par. 0002) wherein there is a display, that is viewable by a patient (see Fig 1) and that can show updates on the patient’s care protocols/treatment steps (Par. 0068 and Fig 5) in order to help the user determine what actions are needed for compliance with the sepsis protocols (Par. 0068).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have taken the teachings of Terry and modified them by having the system display the status of the sepsis protocol administration, as taught and suggested by Fitzgibbons, in order to help the user determine what actions are needed for compliance with the sepsis protocols (Par. 0068 of Fitzgibbons).
In regards to claim 15, the combined teachings of Terry and Fitzgibbons as applied to claim 14 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 of Terry teaches a gateway/router that can transmit the data to an analytics machine to determine sepsis risk).
In regards to claim 16, the combined teachings of Terry and Fitzgibbons as applied to claim 14 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 of Terry teaches the system in communication with medical health records to receive that information).
In regards to claims 18 and 19, the combined teachings of Terry and Fitzgibbons as applied to claim 14 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 of Terry)
In regards to claim 20, the combined teachings of Terry and Fitzgibbons as applied to claim 14 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 of Terry).
Conclusion
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.
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/S.L.C./Examiner, Art Unit 3792
/LYNSEY C Eiseman/Primary Examiner, Art Unit 3796
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