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 Objections
Claims 10 and 17 are objected to because of the following informalities. Appropriate correction is required.
In re claim 10, the limitation “configured to sense one or physiological signals of the patient” should read “configured to sense one or more physiological signals of the patient”.
In re claim 17, the limitation “at least one of video data or audio data from an other device” should read “at least one of video data or audio data from another device”
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 limitations are
“processing circuitry” (claim 1), which according to the specification [0057] the corresponding structure is “any one or more of a microprocessor, a controller, a graphics processing unit (GPU), a tensor processing unit (TPU), a digital signal processor (DSP), an application specific integrated circuit (ASIC), a field-programmable gate array (FPGA), or equivalent discrete or analog logic circuitry”
“communication circuitry” (claim 1), which according to the specification [0063] is “any suitable hardware, firmware, software, or any combination thereof for wirelessly communicating with another device, such as computing devices 12 and/or IoT devices”
Because these claim limitations are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have these limitations 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 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 limitations recite sufficient structure to perform the claimed function so as to avoid 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 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 3 and 10 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.
In re claim 3, the limitation “wherein the intensity comprises a volume of an audible alarm” raises a clarity concern when viewed in combination with claim 2. Examiner notes that claim 2 only requires selecting at least one of “a duration”, “an intensity” or “a modality” of the alarm. Therefore, the requirement of “the intensity comprises a volume of an audible alarm” raises concern given that “intensity” is an optional limitation in the event that either “a duration” or “a modality” are disclosed. Therefore, for examination purposes, claim 3 will be interpreted as follows:
Claim 3. The computing device of claim 2, wherein, to configure the alarm, the processing circuitry is configured to select the intensity of the alarm, wherein the intensity comprises a volume of an audible alarm
In re claim 10, the limitation “The computing device of claim 1, further comprising one or more sensors, separate from the sensor device” raises a clarity concern given that claim 1 does not positively recite “a sensor device”. Examiner notes that claim 1 simply requires a computing device that comprises circuitry “configured to wirelessly communicate with a sensor device”. For examination purposes, claim 10 will be treated similarly, that is, requiring the “computing device” to be able to “wirelessly communicate with one or more sensors” that are “configured to sense one or physiological signals of the patient”.
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 therefore, subject to the conditions and requirements of this title.
Claims 1-6 and 8-21 are rejected under 35 U.S.C 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1:
Independent claims 1, 19 and 21 are directed to a computing device, a system and a method. Thus, the claims are directed to statutory categories of invention. (Step 1: YES)
Step 2A, Prong 1
Independent claims 1, 19 and 21 recite the following limitations:
“determine an alarm context in response to receiving the episode data and based on a type or severity of the acute health event” (mental process and limitations that further limit the mental process of “determine an alarm context”)
The dependent claims recite the following limitations:
“determine the alarm context based on a location of the patient” (further limiting the abstract idea of “determine the alarm context”) (claim 8)
“determine the alarm context based on the second patient parameter data” (further limiting the abstract idea of “determine the alarm context”) (claim 9, 10)
“determine second patient parameter data based on the one or more physiological signals” (claim 10) (mental process and limitations that further limit the mental process of “determine second patient parameter data”)
“wherein the second patient parameter data comprises one or more of respiration data, fluid data, posture data, activity data, heart state data, electrocardiogram data, heart rate variability data, oxygen saturation data, blood pressure data, or sleep stage data” (further limiting abstract idea of “determine second patient parameter data”)(claim 11)
“determine a classification of the acute health event based on the episode data” (mental process)(claim 13)
“determine the alarm context based on the classification” (mental process and limitations that further limit the mental process of “determine the alarm context”) (claim 13)
“determine at least one of a probability or a confidence level of the classification based on the application of the episode data to the one or more machine learning models” (mental process and limitations that further limit the mental process of “determine at least one of a probability or a confidence level”) (claim 15)
“determine the alarm context based on the probability or confidence level” (mental process and limitations that further limit the mental process of “determine the alarm context”) (claim 15)
“determine the alarm context in response to receiving the episode data and based on the video data or the audio data” (mental process and limitations that further limit the mental process of “determine the alarm context”)(claims 16, 17)
“determine the alarm context based on a time of day” (mental process and limitations that further limit the mental process of “determine the alarm context”) (claim 18)
Regarding the limitations directed to a mental process, the courts consider a mental process (thinking) that “can be performed in the human mind, or by a human using a pen and paper to be an abstract idea. Examples of mental processes include observation, judgement, evaluation and opinion. Examiner notes that the courts do not distinguish between claims that recite mental processes performed by humans and claims that recite mental processes performed on a computer. See MPEP 2106.04(a)(2)(III). The limitations listed above are nothing more than a health care professional deciding whether or not they should notify a patient upon receiving episode data indicative of an acute health event.
For the reasons above, Examiner asserts that the claims recite a judicial exception, specifically an abstract idea (Step 2A, Prong 1: Yes).
Step 2A, Prong 2
Claims 1, 19 and 21 recite the following additional elements:
“a computing device” (generic computer component)
“communication circuitry” (generic computer component)
“ a sensor device on a patient or implanted within the patient” (generic component; see Step 2B below)
“one or more output devices” (generic computer component)
“processing circuitry” (generic computer component)
“receive episode data for an acute health event detected by the sensor device via the communication circuitry, the episode data transmitted by the sensor device in response to detecting the acute health event” (insignificant extra solution activity, specifically, data gathering)
“configure an alarm for the acute health event based on the alarm context” (insignificant extra solution activity)
“control the one or more output devices to output the alarm that is configured based on the alarm context” (insignificant extra solution activity)
The above additional elements, “a computing device”, “communication circuitry”, “a sensor device”, “one or more output devices” and “processing circuitry”, are examples of generic computer components. These additional elements fail to provide significantly more because they amount to merely applying the abstract idea using generic computer components.
The remaining additional elements are examples of insignificant extra solution activity. Examiner notes these additional elements fail to provide significantly more because they are insignificant extra solution activity.
The dependent claims 2-6, 8-18 and 20 recite the following additional elements:
“wherein, to configure the alarm, the processing circuitry is configured to select at least one of a duration, an intensity, or a modality of the alarm based on the alarm context” (further limiting the additional element of “configure the alarm”)(claim 2)
“wherein an intensity comprises a volume of an audible alarm” (further limiting the additional element of “configure the alarm”) (claim 3)
“to configure the alarm, the processing circuitry is configured to transmit, via the communication circuitry, a communication to another device configured to cause the other device to output at least a portion of the alarm.” (further limiting the additional element of “configure the alarm”) (claim 4)
“wherein the other device comprises an internet of things device” (further limiting additional element of “transmit…a communication to another device”) (claim 5)
“wherein the Internet of Things device comprises a smart speaker” (further limiting additional element “transmit…a communication to another device” )(claim 6)
“one or more sensors, separate from the sensor device, configured to sense one or physiological signals of the patient , wherein the episode data comprises first patient parameter data” (further limiting existing additional element of “receiving episode data” and generic components used to implement additional element) (claim 10)
“wherein the processing circuitry is configured to increase at least one of the duration or the intensity of the alarm based on at least one of posture data, respiration data, or sleep stage data satisfying one or more low alertness criteria.” (insignificant extra solution activity) (claim 12)
“at least one of a camera configured to generate video data or a microphone configured to generate audio data” (generic computer element)(claim 16)
The additional elements listed above fail to provide significantly more because they amount to insignificant extra solution activity.
Step 2B
The claims do not include any additional elements that amount to significantly more than the judicial exception.
As discussed above, in Step 2A, Prong 2 the additional elements amount to no more than applying the abstract idea using generic computer components and insignificant extra solution activity.
Regarding the limitation “a sensor device…implanted within a patient”, see Arzbaecher et al. (US 2005/0065445) which discloses an implantable medical device (FIG. 1: 15; [0043]). Thus, the limitation “a sensor device…implanted within a patient” is well understood, routine and conventional (as evidenced by Arzbaecher).
Regarding the limitation “configure an alarm for the acute health event based on alarm context” and see Kaib et al. (US 2016/0328529) which discloses a computing device (FIG. 1: 100) that configures an alarm for an event based on determined alarm context (abstract; examples described in [0080-0114]). Thus, the limitation “configure an alarm for the acute health event based on alarm context” is well understood, routine and conventional (as evidenced by Kaib).
Regarding the limitation “control the one or more output devices to output the alarm that is configured based on the alarm context” also see Kaib et al. (US 2016/0328529) which further discloses delivering the alarm based on the alarm context ([0080-0114]). Thus, the limitation “control the one or more output devices to output the alarm that is configured based on the alarm context” is well understood, routine and conventional (as evidenced by Kaib).
Regarding the limitation “increase at least one of the duration or the intensity of the alarm based on at least one of posture data, respiration data, or sleep stage data satisfying one or more low alertness criteria”, also see Kaib et al. (US 2016/0328529) which further discloses modifying features of an alarm (like intensity [0105], duration [0105] and modality [0106]) based on physiological factors like heart rate, respiration, and presence of motion [0105]. Thus, the limitation “increase at least one of the duration or the intensity of the alarm based on at least one of posture data, respiration data, or sleep stage data satisfying one or more low alertness criteria” is well understood, routine, and conventional (as evidenced by Kaib).
Moreover, reconsidering the claim limitations individually and as an ordered combination, the claims fail to meet the requirements for eligibility under 35 U.S.C. 101. (Step 2B: NO)
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 2, 4, 8, 9, 11, 13 and 19-21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fischell et al. (US 7,558,623).
In re claim 1, Fischell discloses, a computing device (FIG. 1: 60) comprising:
communication circuitry (161, 165) configured to wirelessly communicate (col. 15, line 4) with a sensor device (5) on a patient or implanted within the patient (col. 13, line 57: “implanted cardiosaver 5”);
one or more output devices (57); and
processing circuitry (56) configured to:
receive episode data (53) for an acute health event (col. 15, lines 3-5: “cardiac event”) detected by the sensor device via the communication circuitry (col. 15, lines 3-5), the episode data transmitted by the sensor device in response to detecting the acute health event (col. 15, lines 3-5);
determine an alarm context ( FIG. 11: 600; col. 36, lines 38-40) in response to receiving the episode data (apparent see previous bullet) and based on a type or severity (610, 620, 630) of the acute health event;
configure an alarm for the acute health event based on the alarm context (represented by arrows leaving bottom of 610, 620, and 630); and
control the one or more output devices to output the alarm that is configured based on the alarm context (“MAJOR EVENT ALARM”, “SEE DOCTOR ALARM”; described further in col. 4, lines 27-43).
In re claim 2, Fischell discloses, wherein, to configure the alarm the processing circuitry is configured to select at least one of a duration (col. 4, lines 44-49), an intensity, or *a modality (col. 15, lines 12-19) of the alarm based on the alarm context.
*Under the broadest reasonable interpretation “a modality” is being interpreted as the means in which the “the alarm is delivered”.
In re claim 4, Fischell discloses, wherein, to configure the alarm, the processing circuitry is configured to transmit, via the communication circuitry, a communication (65) to another device (device of 67) configured to cause the other device to output at least a portion of the alarm (col. 15, lines 12-19).
In re claim 8, Fischell discloses, wherein the processing circuitry is configured to determine the alarm context based on a location of the patient (col. 5, lines 60-67).
In re claim 9, Fischell discloses,
wherein the episode data comprises first patient parameter data (FIG. 11: “heart rate” being “low”, “normal” or “too high”; col. 32, lines 1-4),
wherein the processing circuitry is configured to:
receive second patient parameter data (FIG. 11: “ST shift events”; col. 32, lines 5-10) from the sensor device; and
determine the alarm context based on the second patient parameter data (see FIG. 11 (611, 612, 613, 615, 621) which shows alarm context being determined at least partially based on a patients “ST shift events”).
In re claim 11, Fischell discloses, wherein the second patient parameter data comprises one or more of
respiration data,
fluid data,
posture data,
activity data,
heart state data,
electrocardiogram data (FIG. 11: “ST shift events”; col. 32, lines 5-10),
heart rate variability data,
oxygen saturation data,
blood pressure data, or
sleep stage data.
In re claim 13, Fischell discloses, wherein the processing circuitry is configured to:
determine a classification of the acute health event based on the episode data (see examples of “classifications” in FIG. 11: “Major EVENT”, “ISCHEMIA”, “MINOR EVNENT”); and
determine the alarm context based on the classification (FIG. 11).
In re claim 19, see above (In re claim 1).
Fischell also discloses,
A system (abstract; FIG. 1) comprising a sensor device (5).
In re claim 20, Fischell discloses wherein the sensor device comprises an insertable cardiac monitor (col. 13, line 57: “implanted cardiosaver 5”).
In re claim 21, see above (In re claim 1).
Fischell also discloses,
A method (col. 4, line 50 – col. 5, line 14; see FIGS. 8-10 which describe specific alarm “routines”).
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.
Claims 3, 10, 12 and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Fischell et al. (US 7,558,623), in view of Kaib et al. (US 2016/0328529).
In re claim 3, Fischell does not disclose, wherein the intensity comprises a volume of an audible alarm.
Kaib discloses an analogous computing device (FIG. 1) that modifies features of an alarm based on situational context (abstract). In one example Kaib discloses selecting a volume level of an alarm according to an urgency of the alarm [0126].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the processing circuitry of Fischell to select an intensity of an alarm based on the alarm context, wherein the intensity comprises a volume of an audible alarm, as taught by Kaib. One would have been motivated to make this modification because doing so would provide another perceivable distinction between alarms that correspond to more and less severe events.
In re claim 10, Fischell discloses
wherein the episode data comprises first patient parameter data (FIG. 11: “heart rate” being “low”, “normal” or “too high”; col. 32, lines 1-4)
Fischell does not disclose,
further comprising one or more sensors, separate from the sensor device, configured to sense one or physiological signals of the patient (see above section Claim Rejections 112b (In re claim 10))
wherein the processing circuitry is configured to:
determine second patient parameter data based on the one or more physiological signals and
determine the alarm context based on the second parameter data.
As mentioned above, Kaib discloses an analogous computing device (FIG. 1) that modifies features of an alarm based on situational context (abstract). As shown in FIG. 1, the computing device includes communication circuitry (106), an output device (108), processing circuitry (118, 114) and a sensor interface (112). The sensor interface enables the computing device to exchange information with one or more sensing devices [0057], including but not limited to: body temperature sensors, respiration monitors, environmental sensors, accelerometers, GPS location, and hygrometers [0059]. Kaib further discloses using physiological data collected by the one or more sensing devices to modify alarm features like intensity [0105], duration [0105], and modality [0106].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the processing circuitry of Fischell to be configured to
wirelessly communicate with one or more sensors that are configured to sense one or more physiological signals of the patient,
determine second patient parameter data based on the one or more physiological signals, and
determine the alarm context based on the second parameter data,
as taught by Kaib. One would have been motivated to make this modification to tailor the alarm to fit the traits and preferences of particular patients (Kaib, [0008]).
In re claim 12, Fischell does not disclose, wherein the processing circuitry is configured to increase at least one of the duration or the intensity of the alarm based on at least one of posture data, respiration data, or sleep stage data satisfying one or more low alertness criteria.
As discussed above, Kaib discloses an analogous computing device (FIG. 1) that modifies features of an alarm based on situational context (abstract). As shown in FIG. 1, the computing device includes a sensor interface (112) that enables the computing device to exchange information with one or more sensing devices [0057]. Kaib further discloses using physiological data collected by the one or more specialized sensing devices to modify features of the alarm like intensity [0105], duration [0105], and modality [0106]. In one example, Kaib discloses increasing the alarm intensity in response to determining that a patient is asleep [0105]. Examiner notes that Kaib describes determining that the patient is asleep by analyzing heart rate, respiration, a time of day, and the presence (or lack) of patient motion [0105].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the processing circuitry of Fischell to be configured to increase the intensity of the alarm based on at least one of posture data, respiration data or sleep stage data satisfying one or more low alertness criteria, as taught by Kaib. One would have been motivated to make this modification because doing so would ensure that the patient still perceives the alarm even if they are in a lower alertness state, e.g., asleep (Kaib, [0105]).
In re claim 17, Fischell discloses, wherein the processing circuitry is configured to:
determine the alarm context in response to receiving the episode data (see above In re claim 1).
Fischell does not disclose the processing circuitry being configured to:
receive at least one of video data or audio data from an other device via the communication circuitry; and
determine the alarm context in response to receiving the episode data and based on the video data or the audio data
As previously disclosed, Kaib discloses an analogous computing device that modifies features of an alarm based on situational context (abstract). In one example, Kaib discloses using audio input to determine if a mood or stress level of a patient may be an inhibiting factor or may affect the patient’s response to the alarm [0096]. If it is determined that the patient is stressed, associated processing circuitry of the computing device may decrease an intensity or duration of the alarm to prevent panic or some other negative reaction [0096].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the processing circuitry of Fischell to be configured to receive at least one of video data or audio data from another device via the communication circuitry and determine the alarm context in response to receiving the episode data and based on the video data or the audio data, as taught by Kaib. One would have been motivated to make this modification to increase the probability that the patient will respond to the alarm in a suitable manner (Kaib, [0008, 0096]).
In re claim 18, Fischell does not disclose, wherein the processing circuitry is configured to determine the alarm context based on a time of day.
As discussed above, Kaib discloses an analogous computing device (FIG. 1) that modifies features of an alarm based on situational context (abstract). In one example, Kaib discloses associated processing circuitry of the computing device adapting alarms to accommodate a time of day in which a patient is normally slow to respond, such as during sleep [0101].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the processing circuitry of Fischell to be configured to determine the alarm context based on a time of day, as taught by Kaib. One would have been motivated to make this modification because doing so would make it such that the alarm is tailored to traits and preferences of the patients (Kaib, [0008]).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Fischell et al. (US 7,558,623), in view of Fischell et al. (US 11,357,439; herein referred to as Fischell II)
In re claim 5, Fischell does not disclose, wherein the other device comprises an Internet of Things device.
Fischell II discloses an analogous computing device (FIG. 3: 120) that is configured to establish a communication protocol that interacts with Internet of Things devices that are established at Emergency departments (col. 19, lines 55-63).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of emergency medical services of Fischell to be an Internet of Things device, as taught by Fischell II. One would have been motivated to make this modification because Emergency Departments are known to have Internet of Things devices that automatically establish time of arrival of a patient after an alarm occurs, as evidenced by Fischell II.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Fischell et al. (US 7,558,623), in view of Fischell et al. (US 11,357,439; herein referred to as Fischell II), in view of Gollakota et al. (US 2023/0363654).
In re claim 6, the proposed combination does not yield, wherein the Internet of Things device comprises a smart speaker.
Gollakota discusses use of smart speaker devices in health monitoring, specifically highlighting their increased adoption in hospital enviornments [0011].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the Internet of Things device of the proposed combination to comprise a smart speaker, given that smart speakers are known to be used in hospital environments as evidenced Gollakota.
Claims 14 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Fischell et al. (US 7,558,623), in view of Sullivan et al. (US 2016/0135706).
In re claim 14, Fischell does not disclose,
wherein the processing circuitry is configured to apply the episode data to one or more machine learning models to determine the classification.
Sullivan discloses an analogous computing device (530) configured to wirelessly communicate (see dotted line connecting 100 and 530) with a wearable medical device (100; [0300]). As disclosed by Sullivan, the computing device may receive electrocardiogram (ECG) data from the wearable medical device and use the electrocardiogram data to detect an acute health event [0300]. In some examples, the acute health event is detected using a machine learning classification system [0300, 0314].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the processing circuitry of Fischell to be configured to apply the episode data to one or more machine learning models to determine the classification, as taught by Sullivan. One would have been motivated to make this modification because use of machine learning models to predict potential health events is known in the art, as evidenced by Sullivan.
In re claim 15, Fischell does not disclose, wherein the processing circuitry is configured to:
determine at least one of a probability or a confidence level of the classification based on the application of the episode data to the one or more machine learning models; and
determine an alarm context based on the probability or confidence level.
Sullivan further discloses having the machine learning classification system determines a risk score associated with the acute health event [0327]. In some instances, a patient’s risk score being above a threshold can lead to a direct notification to the patient, the patient’s medical team, or a responsible third party [0377, 0378] .
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the processing circuitry of Fischell to be configured to 1) determine at least one of a probability or a confidence level of the classification based on the application of the episode data to the one or more machine learning models and 2) determine an alarm context based on the probability or confidence level, as taught by Sullivan. One would have been motivated to make this modification because determining risk scores associated with patients can lead to actionable outcomes that impact the patient’s health, as evidenced by Sullivan [0377, 0378, 0381, 0390].
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Fischell et al. (US 7,558,623).
In re claim 16, Fischell discloses,
wherein the processing circuitry is configured to determine the alarm context in response to receiving the episode data (see above In re claim 1).
Fischell does not disclose,
further comprising at least one of
a camera configured to generate video data or
a microphone configured to generate audio data,
wherein the processing circuitry is configured to determine the alarm context in response to receiving the episode data and based on the video data or the audio data.
An alternative embodiment of Fischell discloses an analogous computing device (FIG. 16: 720) that also includes a microphone (729). As disclosed in Fischell, processing circuitry of the computing device will activate various alarm protocols that in part depend on whether or not an audio connection can be established between a patient and a remote diagnostic center (col. 40, lines 53-col. 41 line 22).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the computing device to further comprise a microphone configured to generate audio data and the processing circuitry to be configured to determine the alarm context in response to receiving the episode data and based on the audio data, as taught by an alternative embodiment of Fischell. One would have been motivated to make this modification to provide the patient with a way to easily contact and communicate with a remote diagnostic center in the case of an emergency (Fischell, col. 40, lines 53-56).
Conclusion
The following prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Gordon et al. (US 2006/0017576) discloses a system (abstract; FIG. 1) that alerts a clinician (32) to an occurrence of an event (abstract) detected by an implantable medical device (24).
Breske et al. (US 2019/0329054) discloses a wearable cardiac defibrillator (104) capable of detecting and determining a severity of an event (abstract). Breske further discloses activating an alarm based on the severity of the event (abstract).
Annamalai (US 2019/0274003) discloses smart speakers being used in a hospital environment to relay information to medical personnel and patients [0018; 0048; 0069; 0080].
Contact
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLIVIA WALKER whose telephone number is (571)272-7052. The examiner can normally be reached M-F: 7-4pm CT.
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/OLIVIA WALKER/Examiner, Art Unit 3796
/DAVID HAMAOUI/SPE, Art Unit 3796
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