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 .
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
communications module, monitoring device, and output module in claim 1
patient verification module in claim 9
patient verification module, communications module, monitoring device, and output module in claim 11
monitoring device, and decompensation module in claim 12
monitoring device, and decompensation module in claim 20
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
Upon review of the disclosure, there appears to be no additional description of the structure of a communications module.
Upon review of the disclosure, the monitoring device appears to comprise the following disclosure(s): “In any of these apparatuses the patient personal output apparatus may include one or more sensors (e.g., non-contract sensors). For example, the control circuitry may further comprise one or more non-contact sensors. In some examples, the one or more non-contact sensors comprises a camera, a LADAR subsystem, or infrared thermography subsystem.” and “In some examples the patient personal output apparatus can be configured to connect to one or more wearable health monitoring devices, such as Apple™ and Samsung™ watches, Fitbits™, etc. This may allow the apparatus to detect and/or prevent decompensation (e.g., sepsis) not only in the community, not limited to inpatient settings. As an example, these apparatuses may combine continuous accelerometry data (e.g., from a Fitbit™ or other patient monitoring device) and/or may use (and combined with) information from the patient’s medical record to enhance the prediction of sepsis readmission. The use of wearable health monitoring devices may allow for continuous monitoring and early detection, even outside of the hospital setting, improving the chances of successful treatment and recovery. The integration of wearable technology into the patient personal output apparatus expands the reach and impact of the solution, further improving patient outcomes.”
Upon review of the disclosure, the output module appears to comprise the following disclosure(s): Fig. 1, “The apparatus may include any output. For example, the one or more outputs may comprise one or more LEDs. The one or more outputs may comprise a screen, display, projector, or speaker. In some examples the body of the patient personal output apparatus is configured to be transparent or translucent and all or a region of the patient personal output apparatus may be configured to be illuminated (e.g., glow, emit light, etc.) that is related to the decompensation score (e.g., risk).”
Upon review of the disclosure, the patient verification module appears to comprise the following disclosure(s): “Any of these patient personal output apparatuses described herein may also optionally include a patient verification module 124, that may verify the patient’s identity and/or may pair the patient to the apparatus. In some examples, patient verification may be based on, or may include, patient proximity. For example, the apparatus may verify and confirm the patient’s identity by voice recognition, by matching the patient to one or more wearable (e.g., identification tags), etc. The apparatuses described herein may also optionally include integrated sensors, such as, e.g., non-contact sensors 128.” and “In order to ensure the accuracy of the patient personal output apparatus, multiple methods of patient identification and authentication may be integrated as part of the patient personal output apparatus. In some examples the apparatus is equipped with voice verification, allowing patients to be identified by their unique vocal characteristics. Alternatively or additionally, the apparatus may utilize location monitoring (GPS) to confirm the patient's location, ensuring that the correct patient is being monitored. In some examples, the apparatus may include a proximity sensor, e.g., using blue-tooth low energy (BLE) technology or others sensing modality (e.g., ultrawideband, RF, etc.) that allows it to detect nearby patient identifiers. This combination of voice verification, location monitoring, and/or wearable (e.g., tag or wristband) identification may provide a robust and secure system for patient identification and authentication, ensuring that the correct patient data is being used and analyzed by the apparatus.”
Upon review of the disclosure, the decompensation module appears to comprise the following disclosure(s): “In one example the trained neural network is ‘Tensorflow Lite’ which is configured to predict Sepsis scores.”
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-11 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim limitation “communications module” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
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 1-22 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 limitation “communications module” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more.
This analysis in view of 35 U.S.C. § 101 is based on MPEP § 2106, please see
this section of the MPEP for additional information.
First, the broadest reasonable interpretation of the claim as a whole is
established:
Claims 1, 11-12, and 20 claim apparatuses and methods for providing personal patient output including a device in proximity to a patient, outputs, control circuitry, and decompensation scoring, the decompensation scoring based on patient data and (depending on the claim) comprising a trained neural network.
Claims 2-3 are directed to aesthetic shape.
Claims 4-5 are directed to the one or more outputs comprising LEDs, a screen, display, projector, or speaker.
Claim 6 includes a memory for storing data obtained from external sources.
Claims 7-8 include non-contact sensors, or a camera, LADAR subsystem, or infrared thermographic subsystem.
Claims 9, 13-14 adds patient verification.
Claim 10, 15-16 specifies the decompensation as sepsis risk, or sepsis, kidney failure, heart failure, or respiratory failure
Claim 17 requires real-time and ongoing determination
Claims 18-19 specify modulation of light emitted by the device and changing the appearance of the device based on the decompensation score and region of the body.
Step 1 of the analysis is the question: “Is the claim to a process, machine,
manufacture, or composition of matter?” and the answer is determined to be yes, as the
claims as a whole are directed to a manufacture and a method.
For Step 2, the preliminary question is whether the eligibility of the claim is self-
evident. The answer is determined to be no, as the claim is not immediately self-evident
as statutory.
Step 2A Prong One: Is the claim directed to a law of nature, a natural phenomenon (product of nature) or an abstract idea?
A claim is directed to a judicial exception when a law of nature, a natural
phenomenon, or an abstract idea is recited (i.e., set forth or described) in the claim.
While the terms “set forth” and “describe” are thus both equated with “recite”, their
different language is intended to indicate that there are different ways in which an
exception can be recited in a claim. For instance, the claims in Diehr set forth a
mathematical equation in the repetitively calculating step, the claims in Mayo set forth
laws of nature in the wherein clause, meaning that the claims in those cases contained
discrete claim language that was identifiable as a judicial exception. The claims in Alice
Corp., however, described the concept of intermediated settlement without ever explicitly using the words “intermediated” or “settlement.”
Claim 1 (and equivalently in claim 13/14) recites the following limitations:
“a communications module configured to communicate with one or more of the patient’s electronic health record”
“a decompensation scoring module comprising a trained neural network configured to output a decompensation score based on the patient data”
The above identified elements comprise an explicit claim recitation of an abstract idea. Therefore, rather than merely involve a judicial exception, the claims are directed to the identified judicial exception.
This claim language is identified as an abstract idea, because in MPEP §
2106.04(a)(2) III B. this language is similar to concepts relating to organizing or
analyzing information in a way that can be performed mentally or are analogous to
human mental work. For example, Synopsys, Inc. v. Mentor Graphics Corp., 839 F.3d
1138, 120 USPQ2d 1473 (Fed. Cir. 2016). In Synopsys, the patentee claimed methods
of logic circuit design, comprising converting a functional description of a level sensitive
latch into a hardware component description of the latch. 839 F.3d at 1140; 120 USPQ2d at 1475. Although the patentee argued that the claims were intended to be
used in conjunction with computer-based design tools, the claims did not include any
limitations requiring computer implementation of the methods and thus do not involve
the use of a computer in any way. 839 F.3d at 1145; 120 USPQ2d at 1478-79. The
court therefore concluded that the claims “read on an individual performing the claimed
steps mentally or with pencil and paper,” and were directed to a mental process of
“translating a functional description of a logic circuit into a hardware component
description of the logic circuit.” 839 F.3d at 1149-50; 120 USPQ2d at 1482-83.
In the instant case, the identified abstract idea is similar to Synopsys because the
language reads on an individual clinician performing the claimed scoring mentally or with a pencil and paper. They do not require any specific computer function for implementation and therefore are directed to a mental process of determining a decompensation score for a patient using externally acquired data and observing and evaluating the patient.
Yes. The claim is directed to an abstract idea.
Step 2A Prong Two: Does the claim recite additional elements that integrate the judicial exception into a practical application?
First, the additional elements are identified.
In claim 1, 11-12, 20: apparatus outer body, outputs, control circuitry, monitoring device, output module
In claims 2-3: outer body shape
In claim 4: LEDs
In claim 5: screen, display, projector, or speaker
In claim 6: memory
In claim 7: non-contact sensors
In claim 8: camera, a LADAR subsystem, or infrared thermography subsystem
In claim 18, 20: modulating a light
In claim 19: outputting a visual indicator
All of the monitoring device, electronic health record, non-contact sensors, and camera, LADAR subsystem, or infrared thermographic subsystem, are only nominally tied to the abstract idea and the data acquisition is all performed as pre-solution activity to the abstract idea claimed. The camera is particularly analogous to human visual observation. Therefore the claimed sensors amount to mere data gathering and considered an insignificant extra-solution activity.
The control circuitry, memory, display, outputs, output module, communication module, speaker, visual outputs, and modulating only lights, etc. appear to be an addition of a general purpose computer post-hoc to an abstract idea and is therefore not considered to transform the abstract idea into patent eligible subject matter. Use of a display is considered to be insignificant extra-solution activity as to displaying certain aspects of the abstract idea. These additional elements appear to use the typical functions of a general purpose computer to facilitate the normal interaction between the physician and patient, but do not rely on any specific computer functions or computer technology. Therefore they appear to be directed to merely implementing the identified abstract idea on a general purpose computer, rather than improving a technology or integrating the abstract idea with a particular machine or technical field.
The remaining features in the claims are directed to further specifying the intended use but do not impose further limits to the recited system because they are generally linking the use of the judicial exception to a particular field of use or technological environment.
Step 2B: Does the claim recite additional elements that amount to significantly
more than the judicial exception?
The additional elements were identified in the above section under Step 2A Prong Two.
All of the monitoring device, electronic health record, non-contact sensors, and camera, LADAR subsystem, or infrared thermographic subsystem, are only nominally tied to the abstract idea and the data acquisition is all performed as pre-solution activity to the abstract idea claimed. The camera is particularly analogous to human visual observation. Therefore the claimed sensors amount to mere data gathering and considered an insignificant extra-solution activity.
The control circuitry, memory, display, outputs, output module, communication module, speaker, visual outputs, and modulating only lights, etc. appear to be an addition of a general purpose computer post-hoc to an abstract idea and is therefore not considered to transform the abstract idea into patent eligible subject matter. Use of a display is considered to be insignificant extra-solution activity as to displaying certain aspects of the abstract idea. These additional elements appear to use the typical functions of a general purpose computer to facilitate the normal interaction between the physician and patient, but do not rely on any specific computer functions or computer technology. Therefore they appear to be directed to merely implementing the identified abstract idea on a general purpose computer, rather than improving a technology or integrating the abstract idea with a particular machine or technical field.
The remaining features in the claims are directed to further specifying the intended use but do not impose further limits to the recited system because they are generally linking the use of the judicial exception to a particular field of use or technological environment.
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.
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.
Claim(s) 1-8, 10, 12, and 15-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Maslik et al. (U.S. Patent Application Publication No. 2021/0398666) hereinafter referred to as Maslik; in view of Chang et al. (U.S. Patent Application Publication No. 2024/0164703) hereinafter referred to as Chang.
Regarding claim 1, Maslik teaches a patient personal output apparatus (¶[0007]), the apparatus comprising:
an outer body (¶[0057] apparatus 120, Fig. 4A-D) configured to be positioned near a patient (Abstract “within a sensing range of the patient” and Fig. 1, Fig. 3A-B);
one or more outputs coupled to the outer body (¶[0073] speaker for user feedback, ¶[0074] RGB indicator lights);
a control circuitry within the outer body (¶[0042] may be processed on the device, ¶[0077]), the control circuitry comprising:
a communications module configured to communicate with one or more of: the patient’s electronic health record, or a monitoring device monitoring the patient to receive patient data (¶[0072], ¶[0077]);
a scoring module (¶[0224]) comprising a trained neural network (¶¶[0201-0202], ¶[0234]) configured to output a score based on the patient data (¶[0224]); and
an output module configured to output a representation of the score (Fig. 2, data monitoring and visualization, ¶[0009] display metrics).
Maslik further teaches detecting early signs of pulmonary decompensation (¶¶[0269-0270]) but does not go so far as to teach a decompensation score based on patient data or present the decompensation score on the body of the device.
Attention is brought to the Chang reference, which teaches a decompensation score based on patient data (¶[0035], ¶[0038]) and outputting the decompensation score on the body of the device (¶[0036]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the monitoring device of Maslik to include calculating and outputting a decompensation score, as taught by Chang, because it provides a “specific, dynamically updating list of patient sepsis levels and associated causal/triggering criteria…improving the capability of the healthcare system, by providing one or more sepsis alert GUIs,” (Chang, ¶[0145]).
Regarding claims 2-3, Maslik as modified teaches the apparatus of claim 1.
Maslik as modified does not teach wherein the outer body is configured as an anthropomorphized animal shape or wherein the outer body is configured as a cartoon animal or mythical creature.
However, upon review of Applicant’s disclosure filed 3/18/2024, there appears to be no specific advantage or criticality to the shape of the device as described.
Therefore, it nevertheless would have been obvious to one of ordinary skill in the art at the time of filing to modify the outer body of the monitoring device of Maslik as modified to be configured in any aesthetic shape, because courts have held that matters relating to ornamentation only which have no mechanical function cannot be relied upon to patentably distinguish the claimed invention from the prior art. In re Seid, 161 F.2d 229, 73 USPQ 431 (CCPA 1947).
Regarding claim 4, Maslik as modified teaches the apparatus of claim 1.
Maslik further teaches wherein the one or more outputs comprises one or more LEDs (¶[0074] RGB LED indicator lights).
Regarding claim 5, Maslik as modified teaches the apparatus of claim 1.
Maslik further teaches wherein the one or more outputs comprises a screen, display, projector, or speaker (¶[0073] speaker).
Regarding claim 6, Maslik as modified teaches the apparatus of claim 1.
Maslik further teaches wherein the control circuitry further comprises a memory for storing data from the patient’s electronic health record, or a monitoring device monitoring the patient (¶[0076] memory for limited data storage).
Regarding claim 7, Maslik as modified teaches the apparatus of claim 1.
Maslik further teaches wherein the control circuitry further comprises one or more non-contact sensors (¶¶[0042-0043], ¶[0050] continuous, non-contact data collection of a patient).
Regarding claim 8, Maslik as modified teaches the apparatus of claim 7.
Maslik further teaches wherein the one or more non-contact sensors comprises a camera, a LADAR subsystem, or infrared thermography subsystem (¶[0071] video, infrared, laser, ¶[0072] thermographic camera).
Regarding claim 10, Maslik as modified teaches the apparatus of claim 1.
Maslik further teaches wherein the scoring module (¶[0224]) comprises a trained neural network (¶¶[0201-0202], ¶[0234]) configured to output a score (¶¶[0269-0270]) based on the patient data (¶[0224]).
Chang further teaches wherein the decompensation scoring module comprises a is configured to output a decompensation score representing a risk of sepsis based on the patient data (¶[0035], ¶[0038]).
Regarding claim 12, the claim is directed to a method comprising substantially the same subject matter as claim 1 and is rejected under substantially the same sections of Maslik and Chang.
Regarding claim 15, Maslik as modified teaches the method of claim 12.
Chang further teaches wherein determining the decompensation score based on the received data comprises determining a risk of one or more of: sepsis (¶[0035], ¶[0038]), kidney failure, heart failure, or respiratory failure.
Regarding claim 16, Maslik as modified teaches the method of claim 12.
Chang further teaches wherein determining the decompensation score based on the received data comprises determining a risk of sepsis (¶[0035], ¶[0038]).
Regarding claim 17, Maslik as modified teaches the method of claim 12.
Chang further teaches wherein determining the decompensation score based on the received data comprises determining the decompensation score in real time in an ongoing manner (¶[0069]).
Claim(s) 2-3 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Maslik and Chang as applied to claim 1 above, and further in view of Kalensky (U.S. Patent Application Publication No. 2019/0224444) hereinafter referred to as Kalensky.
Regarding claims 2-3, Maslik as modified teaches the apparatus of claim 1.
Maslik as modified does not teach wherein the outer body is configured as an anthropomorphized animal shape or wherein the outer body is configured as a cartoon animal or mythical creature.
In case Applicant disagrees with the above rejection of claims 2-3 in view of Maslik and Chang, attention is further drawn to the Kalensky reference, which teaches a patient sensing apparatus comprising an outer body configured as an anthropomorphized animal shape or wherein the outer body is configured as a cartoon animal or mythical creature (Fig. 2 ¶[0014], ¶[0023], ¶[0025]).
It would have been obvious to one of ordinary skill in the art to modify the shape of the monitoring apparatus of Maslik as modified to use a real or imaginary animal from realism or fantasy to promote the cognitive relationship between the patient and the monitoring apparatus (Kalensky ¶[0014]).
Regarding claims 18-19, Maslik as modified teaches the method of claim 12.
Maslik as modified does not teach wherein outputting the visual indicator of the decompensation score from the patient personal output apparatus comprises modulating a light emitted by the patient personal output apparatus while the patient personal output apparatus is positioned proximate to the patient, or wherein outputting the visual indicator of the decompensation score comprises changing the appearance of a region of the patient personal output apparatus corresponding to a region of the body related to the decompensation score.
Maslik in view of Chang, above, teaches the decompensation score.
Attention is drawn to the Kalensky reference, which teaches modulating a light emitted by a patient personal output apparatus while the patient personal output apparatus is positioned proximate to a patient in order to provide a visual indicator of patient status (¶[0041] lighting elements, synchronizing an output pattern to the biometric data) and wherein outputting the visual indicator of the patient health comprises changing the appearance of a region of the patient personal output apparatus corresponding to a region of the body related to the patient health (¶[0041] simulated respiratory, heart, or other synchronization, note the Maslik reference teaches that respiratory rate is an early index for decompensation as shown in the rejection of claims 1 and 12, ¶¶[0061-0062], Fig. 1-2 the outputs are in the region of the body related to respiration, e.g.).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the patient monitoring apparatus of Maslik as modified to include modifying lighting element outputs according to the patient health status, as taught by Kalensky, because Kalensky teaches interaction with a patient health device, including engagement with therapeutic outputs, improves health (Kalensky ¶[0003]).
Regarding claim 20, Maslik teaches a method comprising:
a patient personal output apparatus, (¶[0057] apparatus 120, Fig. 4A-D) that is positioned proximate to the patient (Abstract “within a sensing range of the patient” and Fig. 1, Fig. 3A-B);
receiving data specific to a patient from one or more of: a patient’s electronic health record and/or a monitoring device associated with the patient (¶[0072], ¶[0077]), wherein the data is received by a control circuitry of a patient personal output apparatus (¶[0042] may be processed on the device, ¶[0077]);
determining, from a scoring module (¶[0224]) of the patient personal output apparatus, a score indicating a risk of a health condition (¶[0224]), and based on the received data (¶[0224]); and
outputting a visual indicator of the score (Fig. 2, data monitoring and visualization, ¶[0009] display metrics).
Maslik further teaches detecting early signs of pulmonary decompensation (¶¶[0269-0270]) but does not go so far as to teach a decompensation score based on patient data in real time in an ongoing manner or present the decompensation score on the body of the device by modulating a light emitted by the patient personal output apparatus while the patient personal output apparatus is positioned proximate to the patient, associating the personal patient output apparatus to the patient, or wherein the patient personal output apparatus comprises an anthropomorphized animal shape.
Attention is brought to the Chang reference, which teaches a decompensation score based on patient data (¶[0035], ¶[0038]) in real time in an ongoing manner (¶[0069]) and outputting the decompensation score on the body of the device (¶[0036]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the monitoring device of Maslik to include calculating and outputting a decompensation score, as taught by Chang, because it provides a “specific, dynamically updating list of patient sepsis levels and associated causal/triggering criteria…improving the capability of the healthcare system, by providing one or more sepsis alert GUIs,” (Chang, ¶[0145]).
Maslik as modified does not teach associating the personal patient output apparatus to the patient, or wherein the patient personal output apparatus comprises an anthropomorphized animal shape, modulating a light emitted by the patient personal output apparatus while the patient personal output apparatus is positioned proximate to the patient in order to provide a visual indicator of patient status, associating the personal patient output apparatus to the patient, or wherein the patient personal output apparatus comprises an anthropomorphized animal shape.
Attention is further drawn to the Kalensky reference, which teaches a patient sensing apparatus, associating the patient sensing apparatus to the patient (¶[0018] customized for a specific patient, ¶¶[0070-0071] user specific interactions and learning) and comprising an outer body configured as an anthropomorphized animal shape (Fig. 2 ¶[0014], ¶[0023], ¶[0025]), and modulating a light emitted by the patient personal output apparatus while the patient personal output apparatus is positioned proximate to the patient in order to provide a visual indicator of patient status (¶[0041] lighting elements, synchronizing an output pattern to the biometric data).
It would have been obvious to one of ordinary skill in the art to modify the shape of the monitoring apparatus of Maslik as modified to use a real or imaginary animal from realism or fantasy to promote the cognitive relationship between the patient and the monitoring apparatus (Kalensky ¶[0014]).
Claim(s) 9, 11, and 13-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Maslik and Chang as applied to claims 1 and 12 above, and further in view of Shouldice et al. (U.S. Patent Application Publication No. 2018/0106897) hereinafter referred to as Shouldice.
Regarding claims 9 and 13-14, Maslik as modified teaches the apparatus/method of claim 1/12.
Maslik as modified does not teach associating the patient with the patient personal output apparatus or verifying the patient identity of a patient associated with a patient personal output apparatus.
Attention is drawn to the Shouldice reference, which teaches a non-contact sensing apparatus in the vicinity of a patient (Fig. 1), associating the patient with a patient personal output apparatus (¶¶[0077-0079] a user is considered the specific user of the device by use of a biometric signature creation and verification process) or verifying the patient identity of a patient associated with a patient personal output apparatus (¶[0089]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the monitoring apparatus of Maslik as modified to include patient association and verification, as taught by Shouldice, because authentication is desirable (Shouldice ¶[0020]) for rejection of impersonation with respect to data collection (Shouldice ¶[0021] and to assure compliance (Shouldice, ¶[0021]).
Regarding claim 11, Maslik teaches a patient personal output apparatus (¶[0007]), the apparatus comprising:
an outer body (¶[0057] apparatus 120, Fig. 4A-D) configured to be positioned near a patient (Abstract “within a sensing range of the patient” and Fig. 1, Fig. 3A-B);
one or more outputs coupled to the outer body (¶[0073] speaker for user feedback, ¶[0074] RGB indicator lights);
a control circuitry within the outer body (¶[0042] may be processed on the device, ¶[0077]), the control circuitry comprising:
a communications module configured to communicate with one or more of: the patient’s electronic health record, or a monitoring device monitoring the patient to receive patient data (¶[0072], ¶[0077]);
a scoring module (¶[0224]) comprising a trained neural network (¶¶[0201-0202], ¶[0234]) configured to output a score based on the patient data (¶[0224]); and
an output module configured to output a representation of the score (Fig. 2, data monitoring and visualization, ¶[0009] display metrics).
Maslik further teaches detecting early signs of pulmonary decompensation (¶¶[0269-0270]) but does not go so far as to teach a decompensation score based on patient data or present the decompensation score on the body of the device, or a patient verification module configured to verify the identity of the patient or wherein the outer body is configured as an anthropomorphized animal shape.
Attention is brought to the Chang reference, which teaches a decompensation score representing a risk of sepsis based on patient data (¶[0035], ¶[0038]) and outputting the decompensation score on the body of the device (¶[0036]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the monitoring device of Maslik to include calculating and outputting a decompensation score, as taught by Chang, because it provides a “specific, dynamically updating list of patient sepsis levels and associated causal/triggering criteria…improving the capability of the healthcare system, by providing one or more sepsis alert GUIs,” (Chang, ¶[0145]).
Maslik as modified does not teach wherein the outer body is configured as an anthropomorphized animal shape.
However, upon review of Applicant’s disclosure filed 3/18/2024, there appears to be no specific advantage or criticality to the shape of the device as described.
Therefore, it nevertheless would have been obvious to one of ordinary skill in the art at the time of filing to modify the outer body of the monitoring device of Maslik as modified to be configured in any aesthetic shape, because courts have held that matters relating to ornamentation only which have no mechanical function cannot be relied upon to patentably distinguish the claimed invention from the prior art. In re Seid, 161 F.2d 229, 73 USPQ 431 (CCPA 1947).
Attention is drawn to the Shouldice reference, which teaches a non-contact sensing apparatus in the vicinity of a patient (Fig. 1), associating the patient with a patient personal output apparatus (¶¶[0077-0079] a user is considered the specific user of the device by use of a biometric signature creation and verification process) or verifying the patient identity of a patient associated with a patient personal output apparatus (¶[0089]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the monitoring apparatus of Maslik as modified to include patient association and verification, as taught by Shouldice, because authentication is desirable (Shouldice ¶[0020]) for rejection of impersonation with respect to data collection (Shouldice ¶[0021] and to assure compliance (Shouldice, ¶[0021]).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over unpatentable over Maslik et al. (U.S. Patent Application Publication No. 2021/0398666) hereinafter referred to as Maslik; in view of Chang et al. (U.S. Patent Application Publication No. 2024/0164703) hereinafter referred to as Chang; further in view of Shouldice et al. (U.S. Patent Application Publication No. 2018/0106897) hereinafter referred to as Shouldice; and Kalensky (U.S. Patent Application Publication No. 2019/0224444) hereinafter referred to as Kalensky.
Regarding claim 11, Maslik teaches a patient personal output apparatus (¶[0007]), the apparatus comprising:
an outer body (¶[0057] apparatus 120, Fig. 4A-D) configured to be positioned near a patient (Abstract “within a sensing range of the patient” and Fig. 1, Fig. 3A-B);
one or more outputs coupled to the outer body (¶[0073] speaker for user feedback, ¶[0074] RGB indicator lights);
a control circuitry within the outer body (¶[0042] may be processed on the device, ¶[0077]), the control circuitry comprising:
a communications module configured to communicate with one or more of: the patient’s electronic health record, or a monitoring device monitoring the patient to receive patient data (¶[0072], ¶[0077]);
a scoring module (¶[0224]) comprising a trained neural network (¶¶[0201-0202], ¶[0234]) configured to output a score based on the patient data (¶[0224]); and
an output module configured to output a representation of the score (Fig. 2, data monitoring and visualization, ¶[0009] display metrics).
Maslik further teaches detecting early signs of pulmonary decompensation (¶¶[0269-0270]) but does not go so far as to teach a decompensation score based on patient data or present the decompensation score on the body of the device, or a patient verification module configured to verify the identity of the patient or wherein the outer body is configured as an anthropomorphized animal shape.
Attention is brought to the Chang reference, which teaches a decompensation score representing a risk of sepsis based on patient data (¶[0035], ¶[0038]) and outputting the decompensation score on the body of the device (¶[0036]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the monitoring device of Maslik to include calculating and outputting a decompensation score, as taught by Chang, because it provides a “specific, dynamically updating list of patient sepsis levels and associated causal/triggering criteria…improving the capability of the healthcare system, by providing one or more sepsis alert GUIs,” (Chang, ¶[0145]).
Maslik as modified does not teach a patient verification module configured to verify the identity of the patient or wherein the outer body is configured as an anthropomorphized animal shape.
Attention is drawn to the Shouldice reference, which teaches a non-contact sensing apparatus in the vicinity of a patient (Fig. 1), associating the patient with a patient personal output apparatus (¶¶[0077-0079] a user is considered the specific user of the device by use of a biometric signature creation and verification process) or verifying the patient identity of a patient associated with a patient personal output apparatus (¶[0089]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the monitoring apparatus of Maslik as modified to include patient association and verification, as taught by Shouldice, because authentication is desirable (Shouldice ¶[0020]) for rejection of impersonation with respect to data collection (Shouldice ¶[0021] and to assure compliance (Shouldice, ¶[0021]).
In case Applicant disagrees with the above rejection of claims 11 in view of Maslik, Chang, and Shouldice, attention is further drawn to the Kalensky reference, which teaches a patient sensing apparatus comprising an outer body configured as an anthropomorphized animal shape or wherein the outer body is configured as a cartoon animal or mythical creature (Fig. 2 ¶[0014], ¶[0023], ¶[0025]).
It would have been obvious to one of ordinary skill in the art to modify the shape of the monitoring apparatus of Maslik as modified to use a real or imaginary animal from realism or fantasy to promote the cognitive relationship between the patient and the monitoring apparatus (Kalensky ¶[0014]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
U.S. Patent Application Publication No. 2018/0098739 to Freeman et al. teaches a neural network system outputting early warning scores including risk of sepsis.
U.S. Patent No. 10,490,309 to McNair teaches a neural network model estimating patient risks for decompensation or deterioration, including sepsis as a condition.
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/AMANDA L STEINBERG/ Examiner, Art Unit 3792
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