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 .
Status of Claims
This action is in reply to the application filed on 02/12/2025.
Claims 1-20 are currently pending and have been examined.
Claim Rejections – 35 § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites “analyzing the patient data, so as to determine one or more target rules which are satisfied by the patient data”. It is unclear what is meant by analyzing the patient data. Is the analysis of the patient data being performed by comparing the patient data to a chart or a table? Is the analysis of the patient data being performed by using a specific formula or algorithm? It is unclear what is meant by “so as to determine one or more target rules which are satisfied by the patient data”, as it appears to be intended use. Claim 1 is therefore found to be indefinite, because the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. All dependent claims, namely claims 2-15, are rejected for at least the same reason.
Claim 16 recites “analyzing the patient data, so as to determine a patient state of the patient and a physiological reason which results in the patient state”. It is unclear what is meant by analyzing the patient data. Is the analysis of the patient data being performed by comparing the patient data to a chart or a table? Is the analysis of the patient data being performed by using a specific formula or algorithm? It is unclear what is meant by “so as to determine a patient state of the patient and a physiological reason which results in the patient state”, as it appears to be intended use. Claim 16 is therefore found to be indefinite, because the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. All dependent claims, namely claims 17-20, are rejected for at least the same reason.
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 an abstract idea without significantly more.
Claims 1-20: Step 1
Claims 1-20 are drawn to a system for processing vital information, which is within the four statutory categories (i.e. machine).
Claims 1-20: Step 2A Prong One
Claim 1 recites obtaining multiple types of patient data of a patient, analyzing the patient data to determine one or more target rules which are satisfied by the patient data, and determining a patient state of the patient which corresponds to the one or more target rules. Claim 16 recites obtaining patient data of a patient, analyzing the patient data to determine a patient state of the patient and a physiological reason which results in the patient state, wherein the patient state at least comprises a state of a physiological system of the patient, wherein the physiological system of the patient comprises at least one of a nervous system, a circulatory system, and a respiratory system, of the patient.
These limitations, as drafted, given the broadest reasonable interpretation, but for the recitation of generic computer components, encompass managing personal behavior by manually following rules or instructions, which is a subgrouping of Certain Methods of Organizing Human Activity. But for the recitation of generic computer components, these limitations encompass a user obtaining multiple types of patient data of a patient, analyzing the patient data to determine one or more target rules which are satisfied by the patient data, and determining a patient state of the patient which corresponds to the one or more target rules. But for the recitation of generic computer components, these limitations encompass a user obtaining patient data of a patient, analyzing the patient data to determine a patient state of the patient and a physiological reason which results in the patient state, wherein the patient state at least comprises a state of a physiological system of the patient, wherein the physiological system of the patient comprises at least one of a nervous system, a circulatory system, and a respiratory system, of the patient. These steps could be carried out manually by a user following rules or instructions, which is a subgrouping of Certain Methods of Organizing Human Activity.
Claims 2-15 and 17-20 incorporate the abstract idea identified above and recite additional limitations that expand on the abstract idea, but for the recitation of generic computer components. For example, but for the recitation of generic computer components, Claims 2, 5, 17 and 19 further define analyzing the patient data. Claim 3 further defines determining the patient state. Claim 4 further defines the each preset rule. Claim 6 further defines the analysis result. Claim 7 further defines the operation of determining a patient state. Claim 8 further defines determining a state level of the patient. Claims 9, 10, 12 and 18 further define determining a physiological reason which results in the patient state. Claim 11 further defines controlling the display. Claim 13 further defines the patient state. Claim 14 further defines displaying indication information. Claim 15 further defines the patient data. Claim 20 further defines displaying an indication. Therefore, these claims are similarly drawn to Certain Methods of Organizing Human Activity.
Claims 1-20: Step 2A Prong Two
This judicial exception is not integrated into a practical application because the remaining elements amount to no more than general purpose computer components programmed to perform the abstract ideas along with insignificant, extra-solution data gathering activity, and adding limitations similar to adding the words “apply it” to the abstract idea. Claim 1 recites the additional elements of system for processing vital information, comprising a memory, a processor, and a display, the memory is configured to store an executable program, and the processor is configured to execute the executable program. Claim 16 recites additional elements of a system for processing vital information, comprising a memory, a processor, and a display, the memory is configured to store an executable program, and the processor is configured to execute the executable program.
Claims 1-20, directly or indirectly, recite the following generic computer components: “memory,” and “processor” which are similar to adding the words “apply it” to the abstract idea. The written description does not appear to further describe the computer hardware or the computer program, but rather repeats the recitation from the claim limitations themselves. The written description discloses that the recited computer components encompass generic components including “The processor 120 of the system for processing vital information 100 can be a central processing unit (CPU), or another general-purpose processor, a digital signal processor (DSP), an application-specific integrated circuit (ASIC), a field-programmable gate array (FPGA), or another programmable logic device, a discrete gate or a transistor logic device, a discrete hardware components etc. A general purpose processor may be a microprocessor, or any conventional processor or the likes“ (see at least Paragraph [0327]) and “the memory 110 may include a high-speed random access memory and may also include a non-volatile memory, such as a hard disk, a memory, a plug-in hard disk, a smart memory card, a secure digital card, a flash memory card, multiple disk storage devices, a flash memory device, or another volatile solid-state storage device” (see at least Paragraph [0328]) . Although the additional element “machine learning model” limits the identified judicial exceptions, this type of limitation merely confines the use of the abstract idea to a particular technological environment (machine learning), and thus fails to add an inventive concept to the claims. See MPEP 2106.05 (h). As set forth in the 2019 Eligibility Guidance, 84 Fed. Reg. at 55 “merely include[ing] instructions to implement an abstract idea on a computer” is an example of when an abstract idea has not been integrated into a practical application.
Claims 1-20: Step 2B
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because as discussed above with respect to integration into a practical application, the additional elements (for example, machine learning model) are recited at a high level of generality, and the written description indicates that these elements are generic computer components. Using generic computer components to perform abstract ideas does not provide a necessary inventive concept. See Alice, 573 U.S. at 223 (“mere recitation of a generic computer cannot transform a patent-ineligible abstract idea into a patent-eligible invention.”). As explained above, the generic computer components and machine learning are at best the equivalent of merely adding the words “apply it” to the judicial exception.
Receiving and transmitting data over a network (i.e. receiving and communicating data or signals) has been recognized as well-understood, routine, and conventional activity of a general-purpose computer (see MPEP 2106.05(d) and buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014)).
Gathering and analyzing information using conventional techniques and displaying the result has also been found to be insufficient to show an improvement to technology, (see MPEP 2106.05(a) and TLI Communications, 823 F.3d at 612-13, 118 USPQ2d at 1747-48).
Insignificant, extra solution, data gathering activity has been found to not amount to significantly more than an abstract idea (see MPEP 2106.05(g) and Electric Power Group, LLC v. Alstom S.A., 830 F.3d 1350, 1354-55, 119 USPQ2d 1739, 1742 (Fed. Cir. 2016)). Therefore, the high-level recitation of an output of results also fails to include additional elements that are sufficient to amount to significantly more than the judicial exception.
Therefore, whether considered alone or in combination, the additional elements do not amount to significantly more than the abstract idea.
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.
(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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-6, 8-11, 13-16 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wang et al., WIPO Application Publication WO 2020/132827 A1.
Claim 1:
Wang discloses the following limitations as shown below:
comprising a memory, a processor, and a display (see at least Page 2, A display configured to display information; A memory that stores executable program instructions, and A processor configured to execute executable program instructions to implement the steps);
wherein the memory is configured to store an executable program, and the processor is configured to execute the executable program, so as to enable the processor to perform following operations (see at least Page 2, A memory that stores executable program instructions, and A processor configured to execute executable program instructions to implement the steps):
obtaining multiple types of patient data of a patient (see at least Page 2, acquire at least one physiological data of the monitoring object; Page 3, may include arterial pressure, heart rate, systolic blood pressure, blood oxygen saturation, inhaled oxygen concentration, cardiac preload related parameters, cardiac output related parameters and etc., … It can be understood that the specific types of the physiological parameters listed above are only examples, and other types of physiological parameters may also be included in this embodiment, which is not specifically limited);
analyzing the patient data, so as to determine one or more target rules which are satisfied by the patient data (see at least Page 2, analyze and process the at least one physiological data to obtain an analysis result; Page 4, monitoring device acquires monitoring data of at least one physiological parameter of the monitored object … When the target data satisfies a preset condition, it is determined to correspond to the target data);
determining a patient state of the patient which corresponds to the one or more target rules (see at least Page 5, when the analysis result is that the target data is greater than the first shock risk state threshold, the monitoring device determines that the prompt information is a mild shock risk (reads on “patient state”));
and controlling the display to display indication information which indicates the patient state, and to display at least a portion of the one or more target rules (see at least Page 4, The prompt information is information used to represent the physiological sign state of the monitoring object, and the physiological sign state includes at least one of the volume responsive state, the oxygenation risk state, and the shock risk state, and then displayed on the display interface prompt display Area … analyze and calculate the collected physiological parameter monitoring data to obtain the target data, and use the target data as an indicator to determine the prompt information corresponding to the target data, which is no longer just for a single physiological parameter Threshold alarm, the prompt information displayed by the monitoring equipment is more intelligent and more valuable for reference; Page 6, the display area shown in FIG. 2 is the prompt display area on the display interface of the monitoring device, and the “PPV greater than 15%, with capacity reactivity” displayed on the prompt display area is the prompt information).
Claim 2:
Wang discloses the limitations as shown in the rejections above. Wang further discloses the following limitations:
wherein the memory is further configured to store one or more preset rules (see at least Page 5, It should be noted that the first shock risk state threshold and the second shock risk state threshold can be customized by the user. For example, the user can set the first shock risk state threshold to 1.5 and set the second shock risk state threshold to 2. The present invention does not limit the specific values of the first shock risk state threshold and the second shock risk state threshold; Page 10, memory 501 is used to pre-correlate and store the analysis result and the prompt information based on the physiological data of the monitored object. The prompt information is used for display on the display, and the prompt information includes at least the physiological sign state of the monitored object Description information. Specifically, the association storage of the analysis result and the prompt information may be stored in the form of a correspondence table, or the memory 501 may be an associated memory);
the operation of analyzing the patient data, so as to determine one or more target rules which are satisfied by the patient data, comprises (see at least Page 5, when the analysis result is that the target data is greater than the first shock risk state threshold, the monitoring device determines that the prompt information is a mild shock risk (reads on “patient state”)):
analyzing the patient data, so as to obtain one or more analysis results (see at least Page 5, when the analysis result is that the target data is greater than the first shock risk state threshold, the monitoring device determines that the prompt information is a mild shock risk (reads on “patient state”));
determining whether the one or more analysis results satisfy the one or more preset rules, and using preset rules which are satisfied as the one or more target rules (see at least Page 5, when the analysis result is that the target data is greater than the first shock risk state threshold, the monitoring device determines that the prompt information is a mild shock risk (reads on “patient state”)).
Claim 3:
Wang discloses the limitations as shown in the rejections above. Wang further discloses the following limitations:
wherein the memory is further configured to store corresponding relationship(s) between the preset rules and preset patient states (see at least Page 5, It should be noted that the first shock risk state threshold and the second shock risk state threshold can be customized by the user. For example, the user can set the first shock risk state threshold to 1.5 and set the second shock risk state threshold to 2. The present invention does not limit the specific values of the first shock risk state threshold and the second shock risk state threshold);
the operation of determining a patient state of the patient which corresponds to the one or more target rules, comprises: determining the patient state of the patient which corresponds to the one or more target rules, according to said corresponding relationships (see at least Page 5, when the analysis result is that the target data is greater than the first shock risk state threshold, the monitoring device determines that the prompt information is a mild shock risk (reads on “patient state”)).
Claim 4:
Wang discloses the limitations as shown in the rejections above. Wang further discloses the following limitations:
wherein each preset rule comprises a preset condition for single analysis result, and/or, each preset rule comprises preset conditions for at least two analysis results (see at least Page 5, It should be noted that the first shock risk state threshold and the second shock risk state threshold can be customized by the user. For example, the user can set the first shock risk state threshold to 1.5 and set the second shock risk state threshold to 2. The present invention does not limit the specific values of the first shock risk state threshold and the second shock risk state threshold).
Claim 5:
Wang discloses the limitations as shown in the rejections above. Wang further discloses the following limitations:
wherein the operation of analyzing the patient data, so as to obtain one or more analysis results, comprises (see at least Page 5, when the analysis result is that the target data is greater than the first shock risk state threshold, the monitoring device determines that the prompt information is a mild shock risk (reads on “patient state”)):
analyzing a single type of the patient data, so as to obtain the analysis results; and/or analyzing at least two types of the patient data, so as to obtain the analysis results (see at least Page 5, when the analysis result is that the target data is greater than the first shock risk state threshold, the monitoring device determines that the prompt information is a mild shock risk (reads on “patient state”)).
Claim 6:
Wang discloses the limitations as shown in the rejections above. Wang further discloses the following limitations:
wherein the analysis result comprises at least one of: a parameter value, an event, a result from secondary processing of parameter value, a result from secondary processing of event (see at least Page 5, when the analysis result is that the target data is greater than the first shock risk state threshold, the monitoring device determines that the prompt information is a mild shock risk (reads on “patient state”));
wherein the event comprises at least one of an alarm for exceeding a threshold, an abnormal event, and a clinical event (see at least Page 5, when the analysis result is that the target data is greater than the first shock risk state threshold, the monitoring device determines that the prompt information is a mild shock risk (reads on “patient state”)).
Claim 8:
Wang discloses the limitations as shown in the rejections above. Wang further discloses the following limitations:
determining a state level which represents a severity of the patient state, and controlling the display to display indication information which indicates the state level (see at least Page 5, when the analysis result is that the target data is greater than the first shock risk state threshold, the monitoring device determines that the prompt information is a mild shock risk (reads on “patient state”)).
Claim 9:
Wang discloses the limitations as shown in the rejections above. Wang further discloses the following limitations:
wherein the processor is further configured to perform following operations: reason which results in the patient state according to the patient data (see at least Page 6, the display area shown in FIG. 2 is the prompt display area on the display interface of the monitoring device, and the “PPV greater than 15%, with capacity reactivity” displayed on the prompt display area is the prompt information); and
controlling the display to display indication information which indicates the physiological reason (see at least Page 4, The prompt information is information used to represent the physiological sign state of the monitoring object, and the physiological sign state includes at least one of the volume responsive state, the oxygenation risk state, and the shock risk state, and then displayed on the display interface prompt display Area … analyze and calculate the collected physiological parameter monitoring data to obtain the target data, and use the target data as an indicator to determine the prompt information corresponding to the target data, which is no longer just for a single physiological parameter Threshold alarm, the prompt information displayed by the monitoring equipment is more intelligent and more valuable for reference; Page 6, the display area shown in FIG. 2 is the prompt display area on the display interface of the monitoring device, and the “PPV greater than 15%, with capacity reactivity” displayed on the prompt display area is the prompt information).
Claim 10:
Wang discloses the limitations as shown in the rejections above. Wang further discloses the following limitations:
wherein the memory is further configured to store one or more preset rules, and corresponding relationship(s) between the preset rules and preset physiological reasons (see at least Page 5, It should be noted that the first shock risk state threshold and the second shock risk state threshold can be customized by the user. For example, the user can set the first shock risk state threshold to 1.5 and set the second shock risk state threshold to 2. The present invention does not limit the specific values of the first shock risk state threshold and the second shock risk state threshold; Page 10, memory 501 is used to pre-correlate and store the analysis result and the prompt information based on the physiological data of the monitored object. The prompt information is used for display on the display, and the prompt information includes at least the physiological sign state of the monitored object Description information. Specifically, the association storage of the analysis result and the prompt information may be stored in the form of a correspondence table, or the memory 501 may be an associated memory);
the operation of determining a physiological reason which results in the patient state according to the patient data, comprises: analyzing the patient data, so as to obtain one or more analysis results (see at least Page 2, analyze and process the at least one physiological data to obtain an analysis result; Page 4, monitoring device acquires monitoring data of at least one physiological parameter of the monitored object … When the target data satisfies a preset condition, it is determined to correspond to the target data);
determining whether the one or more analysis results satisfy the one or more preset rules, and using preset rules which are satisfied as the one or more target rules (see at least Page 2, analyze and process the at least one physiological data to obtain an analysis result; Page 4, monitoring device acquires monitoring data of at least one physiological parameter of the monitored object … When the target data satisfies a preset condition, it is determined to correspond to the target data);
determining the physiological reason which results in the patient state according to said corresponding relationships (see at least Page 4, monitoring device acquires monitoring data of at least one physiological parameter of the monitored object … When the target data satisfies a preset condition, it is determined to correspond to the target data; Page 5, when the analysis result is that the target data is greater than the first shock risk state threshold, the monitoring device determines that the prompt information is a mild shock risk (reads on “patient state”)).
Claim 11:
Wang discloses the limitations as shown in the rejections above. Wang further discloses the following limitations:
controlling the display to associatively display at least a portion of the one or more target rules, and the physiological reason (see at least Fig. 3; Page 6, as shown in FIG. 3, the display information includes at least one of waveform display information and numeric display information. Wherein, the waveform display information may include a physiological waveform signal analog waveform diagram and/or a physiological diagram parameter trend diagram).
Claim 13:
Wang discloses the limitations as shown in the rejections above. Wang further discloses the following limitations:
wherein the patient state of the patient comprises at least one of: an overall state of the patient, a state of a physiological system of the patient, a state of an organ of the patient, a state of a physiological part of the patient, a state of a tissue of the patient (see at least Fig. 3; Page 6, as shown in FIG. 3, the display information includes at least one of waveform display information and numeric display information. Wherein, the waveform display information may include a physiological waveform signal analog waveform diagram and/or a physiological diagram parameter trend diagram).
Claim 14:
Wang discloses the limitations as shown in the rejections above. Wang further discloses the following limitations:
wherein the operation of displaying indication information which indicates the patient state, comprises: displaying the patient state via text or graph (see at least Fig. 3; Page 6, as shown in FIG. 3, the display information includes at least one of waveform display information and numeric display information. Wherein, the waveform display information may include a physiological waveform signal analog waveform diagram and/or a physiological diagram parameter trend diagram).
Claim 15:
Wang discloses the limitations as shown in the rejections above. Wang further discloses the following limitations:
wherein the patient data comprises at least one of: vital sign data of the patient, monitoring data and/or device data which is acquired by a ventilator device, monitoring data and/or device data which is acquired by an anesthesia machine, monitoring data and/or device data which is acquired by an infusion pump device, medical condition data, test data, and examination data (see at least Page 5, The physiological parameters obtained by the monitoring device include heart rate and systolic blood pressure);
wherein the vital sign data comprises at least one of: electrocardiogram data, blood pressure data, pulse oximetry data, respiration data, body temperature data, cardiac output data, carbon dioxide data, movement data, video data, respiratory mechanics parameter data, hemodynamic parameter data, oxygen metabolism parameter data, electroencephalogram parameter data, bi- spectral index data, and microcirculation parameter data (see at least Page 5, The physiological parameters obtained by the monitoring device include heart rate and systolic blood pressure); and/or the medical condition data comprises at least one of: basic patient information data, disease diagnosis data, treatment data, nursing data, and electronic medical record data; and/or the test data comprises at least one of: routine blood test data, liver function test data, kidney function test data, thyroid test data, urine test data, immune test data, coagulation test data, blood gas test data, routine stool test data, tumor marker test data; and/or the examination data comprises at least one of: DR imaging data, CT imaging data, MRI imaging data, PET imaging data, ultrasound imaging data, scale data, and physical examination data.
Claim 16:
Wang discloses the following limitations as shown below:
A system for processing vital information, comprising a memory, a processor, and a display (see at least Page 2, A display configured to display information; A memory that stores executable program instructions, and A processor configured to execute executable program instructions to implement the steps);
wherein the memory is configured to store an executable program, and the processor is configured to execute the executable program, so as to enable the processor to perform following operations (see at least Page 2, A memory that stores executable program instructions, and A processor configured to execute executable program instructions to implement the steps):
obtaining patient data of a patient (see at least Page 2, acquire at least one physiological data of the monitoring object; Page 3, may include arterial pressure, heart rate, systolic blood pressure, blood oxygen saturation, inhaled oxygen concentration, cardiac preload related parameters, cardiac output related parameters and etc., … It can be understood that the specific types of the physiological parameters listed above are only examples, and other types of physiological parameters may also be included in this embodiment, which is not specifically limited);
analyzing the patient data, so as to determine a patient state of the patient and a physiological reason which results in the patient state (see at least Page 2, analyze and process the at least one physiological data to obtain an analysis result; Page 4, monitoring device acquires monitoring data of at least one physiological parameter of the monitored object … When the target data satisfies a preset condition, it is determined to correspond to the target data);
wherein the patient state at least comprises a state of a physiological system of the patient (see at least Page 3, The at least one physiological parameter may include arterial pressure, heart rate, systolic blood pressure, blood oxygen saturation, inhaled oxygen concentration, cardiac preload related parameters, cardiac output related parameters and cardiac postload related parameters, etc., wherein the cardiac preload is related);
wherein the physiological system of the patient comprises at least one of: a nervous system, a circulatory system, and a respiratory system, of the patient (see at least Page 3, It can be understood that the specific types of the physiological parameters listed above are only examples, and other types of physiological parameters may also be included in this embodiment, which is not specifically limited herein ; Page 4, The prompt information is information used to represent the physiological sign state of the monitoring object, and the physiological sign state includes at least one of the volume responsive state, the oxygenation risk state, and the shock risk state, and then displayed on the display interface prompt display Area … analyze and calculate the collected physiological parameter monitoring data to obtain the target data, and use the target data as an indicator to determine the prompt information corresponding to the target data, which is no longer just for a single physiological parameter); and
controlling the display to display indication information which indicates the patient state, and to display indication information which indicates the physiological reason (see at least Page 4, The prompt information is information used to represent the physiological sign state of the monitoring object, and the physiological sign state includes at least one of the volume responsive state, the oxygenation risk state, and the shock risk state, and then displayed on the display interface prompt display Area … analyze and calculate the collected physiological parameter monitoring data to obtain the target data, and use the target data as an indicator to determine the prompt information corresponding to the target data, which is no longer just for a single physiological parameter Threshold alarm, the prompt information displayed by the monitoring equipment is more intelligent and more valuable for reference; Page 6, the display area shown in FIG. 2 is the prompt display area on the display interface of the monitoring device, and the “PPV greater than 15%, with capacity reactivity” displayed on the prompt display area is the prompt information);
wherein the indication information which indicates the patient state at least comprises an overall assessment of the state of the physiological system (see at least Page 4, different target data may correspond to different prompt information, and the monitoring device may prompt at least one of a volume reactive state, an oxygenation risk state, or a shock risk state according to the different target data; Page 5, Specifically, when the analysis result is that the target data is less than the first oxygenation risk state threshold, the monitoring device determines that the prompt information is mild oxygenation risk. When the analysis result is that the target data is less than the second oxygenation risk state threshold, the monitoring device determines that the prompt message is serious oxygenation risk. It is understandable that both mild oxygenation risk and severe oxygenation risk belong to one of the oxygenation risk states).
Claim 20:
Wang discloses the limitations as shown in the rejections above. Wang further discloses the following limitations:
wherein, displaying indication information which indicates the physiological reason, comprises: associatively displaying the indication information which indicates the physiological reason and at least a portion of the one or more target rules (see at least Page 4, The prompt information is information used to represent the physiological sign state of the monitoring object, and the physiological sign state includes at least one of the volume responsive state, the oxygenation risk state, and the shock risk state, and then displayed on the display interface prompt display Area … analyze and calculate the collected physiological parameter monitoring data to obtain the target data, and use the target data as an indicator to determine the prompt information corresponding to the target data, which is no longer just for a single physiological parameter Threshold alarm, the prompt information displayed by the monitoring equipment is more intelligent and more valuable for reference; Page 6, the display area shown in FIG. 2 is the prompt display area on the display interface of the monitoring device, and the “PPV greater than 15%, with capacity reactivity” displayed on the prompt display area is the prompt information).
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 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 of this title, if the differences between the claimed invention and the prior art axe 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.
Claims 7 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al., WIPO Application Publication WO 2020/132827 A1 in view of Golan et al., U.S. Patent Application Publication U.S. 2022/0406460 A1.
Claim 7:
Wang discloses the limitations as shown in the rejections above. Wang may not specifically disclose the following limitations, but Golan as shown does:
using the patient data and a first machine learning model for determining patient state to determine the patient state of the patient which corresponds to the one or more target rules (see at least Paragraph 57, The application can include and/or interface with any suitable algorithms or models (e.g., AI models, machine learning models, deep learning models, etc.) for analysis (e.g., at a computing and/or processing system, retrieved from storage, retrieved from remote storage, etc.), and part or all of the method 200 can be performed by a processor associated with the application; Paragraph 135, for each of the set of parameters, comparing a portion or all of the set of parameters with a set of thresholds to determine if an associated condition is suspected; if a condition is suspected, further processing (e.g., with a set of models and/or algorithms, with a set of rules and/or lookup tables and/or databases, etc.) any or all of the associated set of parameters (e.g., a different subset of parameters than those used to detect the suspected condition, a same subset of parameters as those used to detect the suspected condition, an overlapping subset with those used to detect the suspected condition, etc.) to determine a set of recommendations (e.g., recommended device and/or treatment for the pathology, recommended specialist to contact, etc.) )
At the time of the filing of the application it would have been obvious to one of ordinary skill in the art to combine the teaching of the display and monitoring method and system of Wang with the computer-aided decision guidance of Golan with the motivation of providing “… the benefit of helping physicians make fast and accurate decisions related to the treatment (e.g., surgery, drug administration, etc.) of patients experiencing an acute, time-sensitive condition (e.g., stroke), which can in turn function to reduce waste, improve outcomes, and/or otherwise benefit the patient or users” (Golan, see at least Paragraph 18).
Claim 12:
Wang discloses the limitations as shown in the rejections above. Wang may not specifically disclose the following limitations, but Golan as shown does:
using the patient data and a second machine learning model for determining physiological reason to determine the physiological reason which results in the patient state (see at least Paragraph 57, The application can include and/or interface with any suitable algorithms or models (e.g., AI models, machine learning models, deep learning models, etc.) for analysis (e.g., at a computing and/or processing system, retrieved from storage, retrieved from remote storage, etc.), and part or all of the method 200 can be performed by a processor associated with the application; Paragraph 77, In another set of variations, S210 includes receiving a set of signals (e.g., ECG signals, heart rate signals, etc.) from a signal collection device (e.g., ECG signal collection device, heart rate monitor, blood pressure cuff, vital signs monitor, etc.); Paragraph 85, Additionally or alternatively, S220 can include annotating any or all of the set of images (e.g., to efficiently indicate particular regions to a user, to convey measurements and/or parameters associated with a suspected pathological condition and/or anatomical region, to indicate a potential and/or recommended surgical pathway, etc.) and/or any other processes; Paragraph 135, for each of the set of parameters, comparing a portion or all of the set of parameters with a set of thresholds to determine if an associated condition is suspected; if a condition is suspected, further processing (e.g., with a set of models and/or algorithms, with a set of rules and/or lookup tables and/or databases, etc.) any or all of the associated set of parameters (e.g., a different subset of parameters than those used to detect the suspected condition, a same subset of parameters as those used to detect the suspected condition, an overlapping subset with those used to detect the suspected condition, etc.) to determine a set of recommendations (e.g., recommended device and/or treatment for the pathology, recommended specialist to contact, etc.)).
At the time of the filing of the application it would have been obvious to one of ordinary skill in the art to combine the teaching of the display and monitoring method and system of Wang with the computer-aided decision guidance of Golan for at least the same reasons given for claim 7 above.
Claims 17, 18 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al., WIPO Application Publication WO 2020/132827 A1 in view of Burton, U.S. Patent Application Publication U.S. 2021/0169417 A1.
Claim 17:
Wang discloses the limitations as shown in the rejections above. Wang further discloses the following limitations:
analyzing the patient data, so as to determine one or more target rules which are satisfied by the patient data (see at least Page 2, analyze and process the at least one physiological data to obtain an analysis result; Page 4, monitoring device acquires monitoring data of at least one physiological parameter of the monitored object … When the target data satisfies a preset condition, it is determined to correspond to the target data); and
determining the physiological reason which corresponds to said one or more target rules (see at least Page 4, The prompt information is information used to represent the physiological sign state of the monitoring object, and the physiological sign state includes at least one of the volume responsive state, the oxygenation risk state, and the shock risk state, and then displayed on the display interface prompt display Area … analyze and calculate the collected physiological parameter monitoring data to obtain the target data, and use the target data as an indicator to determine the prompt information corresponding to the target data, which is no longer just for a single physiological parameter Threshold alarm, the prompt information displayed by the monitoring equipment is more intelligent and more valuable for reference; Page 6, the display area shown in FIG. 2 is the prompt display area on the display interface of the monitoring device, and the “PPV greater than 15%, with capacity reactivity” displayed on the prompt display area is the prompt information);
when the physiological system of the patient comprises the circulatory system of the patient, said one or more target rules comprise an indicator which is related to hemodynamics or perfusion (see at least Page 2, acquire at least one physiological data of the monitoring object; Page 3, may include arterial pressure, heart rate, systolic blood pressure, blood oxygen saturation, inhaled oxygen concentration, cardiac preload related parameters, cardiac output related parameters and etc., … It can be understood that the specific types of the physiological parameters listed above are only examples, and other types of physiological parameters may also be included in this embodiment, which is not specifically limited; Page 5, The physiological parameters obtained by the monitoring device include heart rate and systolic blood pressure);
when the physiological system of the patient comprises the respiratory system of the patient, said one or more target rules comprise an indicator which is related to oxygenation (see at least Page 4, The prompt information is information used to represent the physiological sign state of the monitoring object, and the physiological sign state includes at least one of the volume responsive state, the oxygenation risk state, and the shock risk state, and then displayed on the display interface prompt display Area … analyze and calculate the collected physiological parameter monitoring data to obtain the target data, and use the target data as an indicator to determine the prompt information corresponding to the target data, which is no longer just for a single physiological parameter Threshold alarm, the prompt information displayed by the monitoring equipment is more intelligent and more valuable for reference).
Wang may not specifically disclose the following limitations, but Burton as shown does:
wherein when the physiological system of the patient comprises the nervous system of the patient, said one or more target rules comprise an indicator which is related to a cranial nerve (see at least Paragraph 1234, The activity may be seen in the chin or anterior tibial EMG derivations, as well as in EEG or EOG deviations, the latter indicating activity of cranial nerve innervated muscles such as the facial muscles and scalp. The activity is maximal in association with rapid eye movements.), EEG activity in range of 4-7 Hz combined with slowing of background frequencies (i.e. by >1 Hz from those of stage wake), sleep spindle, drowsiness, vigilance, attention, sleep; [1235] “health conditions” relating to any sleep parameter related measures or associated indices can include (but is not limited to) sleep efficiency, wake after sleep onset, delayed sleep measures, sleep-architecture measures, deep-sleep measures, REM sleep measures, and other sleep indices) ;
At the time of the filing of the application it would have been obvious to one of ordinary skill in the art to combine the teaching of the display and monitoring method and system of Wang with the system feature of Burton with the motivation of providing the benefit “… to improve personal and mobile access to health-monitoring, analysis and ultimately improved quality of life and health outcomes using minimalisation monitoring techniques, unique automatic and optionally online analysis processes, and devices capable of providing combined routine sleep and health management tracking with enhanced data access” (Burton, see at least Paragraph 2148).
Claim 18:
The combination of Wang/Burton discloses the limitations as shown in the rejections above. Wang further discloses the following limitations:
wherein the memory is further configured to store multiple preset rules, and corresponding relationships between said preset rules and preset physiological reasons (see at least Page 5, It should be noted that the first shock risk state threshold and the second shock risk state threshold can be customized by the user. For example, the user can set the first shock risk state threshold to 1.5 and set the second shock risk state threshold to 2. The present invention does not limit the specific values of the first shock risk state threshold and the second shock risk state threshold; Page 10, memory 501 is used to pre-correlate and store the analysis result and the prompt information based on the physiological data of the monitored object. The prompt information is used for display on the display, and the prompt information includes at least the physiological sign state of the monitored object Description information. Specifically, the association storage of the analysis result and the prompt information may be stored in the form of a correspondence table, or the memory 501 may be an associated memory);
the operation of determining the physiological reason which corresponds to said one or more target rules, comprises: determining the physiological reason, which corresponds to said one or more target rules and results in the patient state, according to said corresponding relationship(s) which is(are) stored by the memory (see at least Page 2, analyze and process the at least one physiological data to obtain an analysis result; Page 4, monitoring device acquires monitoring data of at least one physiological parameter of the monitored object … When the target data satisfies a preset condition, it is determined to correspond to the target data; Page 5, when the analysis result is that the target data is greater than the first shock risk state threshold, the monitoring device determines that the prompt information is a mild shock risk (reads on “patient state”) … It should be noted that the first shock risk state threshold and the second shock risk state threshold can be customized by the user. For example, the user can set the first shock risk state threshold to 1.5 and set the second shock risk state threshold to 2. The present invention does not limit the specific values of the first shock risk state threshold and the second shock risk state threshold; Page 10, memory 501 is used to pre-correlate and store the analysis result and the prompt information based on the physiological data of the monitored object. The prompt information is used for display on the display, and the prompt information includes at least the physiological sign state of the monitored object Description information. Specifically, the association storage of the analysis result and the prompt information may be stored in the form of a correspondence table, or the memory 501 may be an associated memory).
Claim 19:
Wang discloses the limitations as shown in the rejections above. Wang further discloses the following limitations:
analyzing the patient data, so as to determine one or more target rules which are satisfied by the patient data (see at least Page 2, analyze and process the at least one physiological data to obtain an analysis result; Page 4, monitoring device acquires monitoring data of at least one physiological parameter of the monitored object … When the target data satisfies a preset condition, it is determined to correspond to the target data); and
determining the patient state which corresponds to said one or more target rules (see at least Page 5, when the analysis result is that the target data is greater than the first shock risk state threshold, the monitoring device determines that the prompt information is a mild shock risk (reads on “patient state”));
when the physiological system of the patient comprises the circulatory system of the patient, said one or more target rules comprise an indicator which is related to hemodynamics or perfusion (see at least Page 2, acquire at least one physiological data of the monitoring object; Page 3, may include arterial pressure, heart rate, systolic blood pressure, blood oxygen saturation, inhaled oxygen concentration, cardiac preload related parameters, cardiac output related parameters and etc., … It can be understood that the specific types of the physiological parameters listed above are only examples, and other types of physiological parameters may also be included in this embodiment, which is not specifically limited; Page 5, The physiological parameters obtained by the monitoring device include heart rate and systolic blood pressure);
when the physiological system of the patient comprises the respiratory system of the patient, said one or more target rules comprise an indicator which is related to oxygenation (see at least Page 4, The prompt information is information used to represent the physiological sign state of the monitoring object, and the physiological sign state includes at least one of the volume responsive state, the oxygenation risk state, and the shock risk state, and then displayed on the display interface prompt display Area … analyze and calculate the collected physiological parameter monitoring data to obtain the target data, and use the target data as an indicator to determine the prompt information corresponding to the target data, which is no longer just for a single physiological parameter Threshold alarm, the prompt information displayed by the monitoring equipment is more intelligent and more valuable for reference).
Wang may not specifically disclose the following limitations, but Burton as shown does:
wherein when the physiological system of the patient comprises the nervous system of the patient, said one or more target rules comprise an indicator which is related to a cranial nerve (see at least Paragraph 1234, The activity may be seen in the chin or anterior tibial EMG derivations, as well as in EEG or EOG deviations, the latter indicating activity of cranial nerve innervated muscles such as the facial muscles and scalp. The activity is maximal in association with rapid eye movements.), EEG activity in range of 4-7 Hz combined with slowing of background frequencies (i.e. by >1 Hz from those of stage wake), sleep spindle, drowsiness, vigilance, attention, sleep; [1235] “health conditions” relating to any sleep parameter related measures or associated indices can include (but is not limited to) sleep efficiency, wake after sleep onset, delayed sleep measures, sleep-architecture measures, deep-sleep measures, REM sleep measures, and other sleep indices);
At the time of the filing of the application it would have been obvious to one of ordinary skill in the art to combine the teaching of the display and monitoring method and system of Wang with the system feature of Burton for at least the same reasons given for claim 17 above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Joy Chng whose telephone number is 571.270.7897. The examiner can normally be reached on Monday-Friday, 9:00am-5:00pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, JASON DUNHAM can be reached on 571.272.8109. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Joy Chng/
Primary Examiner, Art Unit 3686
Prosecution Insights