Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant’s arguments, see Remarks, filed 11/14/2025, with respect to the rejections under 35 USC 101 have been fully considered and are persuasive in light of the amendments. The 35 USC 101 rejections of claims 1-15 has been withdrawn.
Applicant's arguments filed 11/18/2025 have been fully considered but they are not persuasive. The applicant argues that the reference of Gerber does not require that the physiological parameter and temperature to be obtained at the same time and therefore the simultaneous recording of the parameters in the present invention is novel and patentable over the prior art. However, Gerber teaches that “the monitored indicator is indicative of an infection (520, 540), as appropriate depending on whether an event is determined to have occurred within a predetermined period of time or is occurring (530)” ([0059]). Both the physiological parameter and the temperature are “monitored indicators” and both are analyzed in a “predetermined period of time”.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-14 is/are rejected under 35 U.S.C. 103 as being obvious in view of Lee et al (US20080064980A1); hereinafter Lee (cited previously), Gerber et al (US20080262379A1); hereinafter Gerber (both cited previously), and Centers for Medicare and Medicaid Services Guide to Choosing a Hospital (https://www.tha.org/wp-content/uploads/2024/04/Guide-to-Choosing-a-Hospital.pdf).
Regarding claim 1, Lee discloses an active implantable medical device (chronically implanted sensor [0006]), comprising a processor (microprocessor 64), a memory unit (memory 62), a detection unit (sensors 78) configured to detect a cardiac physiologic parameter (CRM devices [0024], heart rate [0056]), and a temperature sensor for sensing a body temperature (temperature sensor [0034]), wherein the memory unit comprises a computer-readable program (program storage [0034]) that causes the processor to perform the following steps when executed on the processor:
a) causing the temperature sensor to repeatedly sense a body temperature of a person to whom the active implantable medical device is implanted (temperature changes [0037] - measuring changes implies that it is measured repeatedly);
b) storing body temperature values ([0034] memory is for data storage and data comprises temperature) obtained in step a) in the memory unit;
c) causing the detection unit to repeatedly sense a cardiac physiologic parameter of the person ([0056] detecting a trend requires repeated detection);
d) storing cardiac physiologic parameter values obtained in step c) in the memory unit ([0034] memory is for data storage and data comprises cardiac physiological parameters);
e) determining whether at least one of the body temperature values exceeds a predefined body temperature threshold (check to see if physiological parameters (temperature) have exceeded a particular threshold value [0047]);
f) classifying an infection of the person as a systemic infection by determining that at least one of the cardiac physiologic parameter values obtained exceeds a predefined cardiac physiologic parameter threshold ([0056] heart rate greater than about 90 beats per minute), ([0057] body temperature of greater than 100 degrees Fahrenheit)
g) classifying an infection of the person as a local infection by determining that at least one of the cardiac physiological parameter values obtained does not exceed the predefined cardiac physiological parameter threshold (fig 12 yes in step 704 and no in step 708), ([0039] where the temperature of pocket is found to increase, this may indicate the presence of infection in pocket 322);
wherein the cardiac physiologic parameter includes a heart rate and/or a heart rate at rest([0056]), wherein the computer-readable program causes the processor to determine an excess of the cardiac physiologic parameter threshold when the heart rate or the heart rate at rest is at least 110% of a mean heart rate([0056] increased heart rate over average, >90 bpm) or a mean heart rate at rest, respectively, over a first number of last days prior to the determining ([0048] setting a time frame), wherein the first number is a number chosen from a range between 3 and 400 ([0049] the actual time period used for changing thresholds can depend on various factors),
wherein when the infection is classified as a systemic infection the patient is classified for treatment in a hospital specialized on the treatment of infectious diseases, and wherein when the infection is classified as a local infection the patient is classified for treatment at a hospital not specialized on the treatment of infectious disease ([0006] use of sensors to monitor for signs of infection, where often these signs of infection are sub-clinical, allowing early intervention, and possibly preventing the need for system explant and subsequently preventing complications – the early intervention is when the infection is identified as local and the system explant is when the infection is identified as systemic, see also the difference in step 506 in fig. 9 and step 606 in fig. 10, see also fig. 12 where an alert or intervention occurs is the infection is systemic and an urgent alert is sent if the infection is systemic, claim 24 treatment threshold).
Lee discloses using a heart rate above 90 bpm to indicate an infection but does not explicitly mention a heart rate above 110% of a mean heart rate at rest. However, the Examiner notes that a typical average resting heart rate of a human adult is approximately 60 bpm, thus making 90 bpm well above 110% of a typical resting heart rate. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to utilize a threshold of at least 110% of a resting heart rate to detect an elevated heart rate, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Lee fails to teach the step of providing advice for which kind of medical center to go to based on the result of the determination. Centers teaches:
h) when the infection is classified as a local infection, providing advice to the person to be examined and/or treated in a hospital or medical center that has performed the implantation of the active implantable medical device (page 7 - some considerations patients should make are “Which hospitals have the best experience with your condition?”, and “Should you consider a specialty hospital…”); and
i) when the infection is classified as a systemic infection, providing advice to the person to contact a hospital or medical center specialized in management and treatment of pandemic diseases (pg. 7 - some considerations patients should make are “Which hospitals have the best experience with your condition?”, and “Should you consider a specialty hospital…”)
It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify Lee with Centers because it is well-known and prima facie obvious to select a hospital that is suited to treat the type of infection or disorder a patient has.
Lee discloses that checking temperature and/or heart rate does distinguish between local infections and systemic infections (sepsis) ([0059]) but does not disclose checking temperature first before checking heart rate as required in step f or that the period of time in which the physiological parameter is measured is the same as when the temperature is measured. Gerber teaches checking temperature first before checking heart rate in a same time period that the body temperature value exceeds the predefined body temperature threshold as required in step f (fig. 6 – parts 520 and 540, [0055] whether a value associated with the monitored information has crossed a first threshold indicative of infection (520). For example, processor 110 may compare a value associated with the monitored indicator to a value in a look-up table stored in memory 120 (see, e.g. FIG. 7) to determine whether the first threshold is crossed. If the first threshold is not crossed, the indicator of infection may continue to be monitored (500). If the threshold is crossed, a determination may be made as to whether an event associated with the device has occurred (530). The event is one that may affect a monitored indicator value or a determination as to whether the monitored indicator is indicative of infection. If the event has not occurred within a predetermined time frame), ([0059] predetermined period of time). It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify Lee with Gerber because there is some teaching, suggestion, or motivation to do so. Gerber teaches this “can be used to monitor an infection in proximity to an implanted medical device and which take into account events that may affect the monitored indicator when making a determination as to whether an infection is in proximity to the implanted device” ([0007]).
Regarding claim 2, the combination of Lee and Gerber discloses an active implantable medical device according to claim 1, wherein the active implantable medical device is an implantable pulse generator([0027] device includes pulse generator 28), an implantable cardioverter-defibrillator([0023]), a cardiac resynchronization therapy device([0023]), or a neurostimulator([0061] implantable neurostimulation devices).
Regarding claim 3, the combination of Lee and Gerber discloses an active implantable medical device according to claim 1, wherein the cardiac physiologic parameter further includes a respiratory rate([0055]), or a cardiac impedance([0060]).
Regarding claim 4, the combination of Lee and Gerber discloses an active implantable medical device according to claim 1, wherein the cardiac physiologic parameter is a heart rate or a heart rate at rest , wherein the cardiac physiologic parameter threshold is a heart rate in a range of 80 to 110 beats per minute([0056] increased heart rate over average, >90 bpm).
Regarding claim 5, the combination of Lee and Gerber discloses an active implantable medical device according to claim1, wherein the body temperature threshold is a temperature lying in a range from 37.5°C (99.5 degrees F) to 38.5°C (101.3 degrees Fahrenheit) ([0057] body temperature of greater than 100 degrees Fahrenheit or a body temperature of less than 96 degrees Fahrenheit).
Regarding claim 6, the combination of Lee and Gerber discloses an active implantable medical device according to claim 1, characterized in that the computer-readable program causes the processor to sense the body temperature multiple times per day ([0046] - [0047] continuous monitoring implies multiple times per day).
Regarding claim 7, the combination of Lee and Gerber discloses an active implantable medical device according to claim 1, wherein the computer-readable program causes the processor to sense the body temperature for multiple days ([0046] over a period of time, [0048] monitoring period can be several months).
Regarding claim 8, the combination of Lee and Gerber discloses an active implantable medical device according claim1, wherein the computer-readable program causes the processor to output an alert ([0059] alert or notification) if the actual body temperature value exceeds the body temperature threshold ([0059] if an infection is detected) and if optionally also the cardiac physiologic parameter value exceeds the cardiac physiologic parameter threshold ([0059]).
Regarding claim 9, Lee discloses an arrangement ([0008]), comprising an active implantable medical device ([0008] implantable medical device)and an evaluation unit ([0027] programmer) separate from the active implantable medical device (outside the patient's body, near the patient), wherein the active implantable medical device comprises a first processor (circuitry for processing signals), a first memory unit(memory 62), a detection unit (sensors 78) configured to detect a cardiac physiologic parameter(atrial sensing channel), a temperature sensor for sensing a body temperature([0034] sensors 78 includes temperature sensor), and a data communication unit(controller 18, telemetry module 80), wherein the first memory unit comprises a first computer-readable program that causes the first processor to perform the following steps when executed on the first processor ([0027]):
causing the temperature sensor to repeatedly sense a body temperature of a person to whom the active implantable medical device is implanted (temperature changes [0037] - measuring changes implies that it is measured repeatedly);
causing the detection unit to repeatedly sense a cardiac physiologic parameter of the person ([0056] detecting a trend requires repeated detection);
transmitting body temperature values obtained in step a) and cardiac physiologic parameters obtained in step b) via the data communication unit to the evaluation unit located outside a body of the person ([0027] communicating with device outside patient's body); and in that the evaluation unit comprises a second processor ([0034]) and a second memory unit ([0034]), wherein the second memory unit comprises a second computer-readable program that causes the second processor to perform the following steps when executed on the second processor (the external programmer can be a patient management system which includes a processor and a memory unit):
storing body temperature values ([0034] memory is for data storage and data comprises temperature) obtained in step a) in the second memory unit;
determining that at least one of the body temperature values exceeds a predefined body temperature threshold (check to see if physiological parameters (temperature) have exceeded a particular threshold value [0047]);
classifying an infection of the person as a systemic infection by determining that at least one of the cardiac physiologic parameter values exceeds a predefined cardiac physiologic parameter threshold ([0056] heart rate greater than about 90 beats per minute)([0057] body temperature of greater than 100 degrees Fahrenheit)
classifying an infection of the person as a local infection by determining that at least one of the cardiac physiological parameter values obtained within time period Tphys ([0059] predetermined period of time) does not exceed the predefined cardiac physiological parameter (fig 12 yes in step 704 and no in step 708)
wherein the cardiac physiologic parameter is a heart rate or a heart rate at rest([0056]), wherein the computer-readable program causes the processor to determine an excess of the cardiac physiologic parameter threshold if the heart rate or the heart rate at rest is at least 110% of a mean heart rate([0056] increased heart rate over average, >90 bpm) or a mean heart rate at rest, respectively, over a first number of last days prior to the determining ([0048] setting a time frame),
wherein the first number is a number chosen from a range between 3 and 400 ([0049] the actual time period used for changing thresholds can depend on various factors).
wherein when the infection is classified as a systemic infection the patient is classified for treatment in a hospital specialized on the treatment of infectious diseases, and wherein when the infection is classified as a local infection the patient is classified for treatment at a hospital not specialized on the treatment of infectious disease ([0006] use of sensors to monitor for signs of infection, where often these signs of infection are sub-clinical, allowing early intervention, and possibly preventing the need for system explant and subsequently preventing complications – the early intervention is if the infection is identified as local and the system explant is if the infection is identified as systemic, see also the difference in step 506 in fig. 9 and step 606 in fig. 10, see also fig. 12 where an alert or intervention occurs is the infection is systemic and an urgent alert is sent if the infection is systemic, claim 24 treatment threshold).
Lee fails to teach the step of providing advice for which kind of medical center to go to based on the result of the determination. Centers teaches:
h) when the infection is classified as a local infection, providing advice to the person to be examined and/or treated in a hospital or medical center that has performed the implantation of the active implantable medical device (page 7 - some considerations patients should make are “Which hospitals have the best experience with your condition?”, and “Should you consider a specialty hospital…”); and
i) when the infection is classified as a systemic infection, providing advice to the person to contact a hospital or medical center specialized in management and treatment of pandemic diseases (pg. 7 - some considerations patients should make are “Which hospitals have the best experience with your condition?”, and “Should you consider a specialty hospital…”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify Lee with Centers it is well-known and prima facie obvious to select a hospital that is suited to treat the type of infection or disorder a patient has.
Lee discloses that checking temperature and/or heart rate does distinguish between local infections and systemic infections (sepsis) ([0059]) but does not disclose checking temperature first before checking heart rate as required in step f. Gerber teaches checking temperature first before checking heart rate in a same time period that the body temperature value exceeds the predefined body temperature threshold as required in step f (fig. 6 – parts 520 and 540, [0055] whether a value associated with the monitored information has crossed a first threshold indicative of infection (520). For example, processor 110 may compare a value associated with the monitored indicator to a value in a look-up table stored in memory 120 (see, e.g. FIG. 7) to determine whether the first threshold is crossed. If the first threshold is not crossed, the indicator of infection may continue to be monitored (500). If the threshold is crossed, a determination may be made as to whether an event associated with the device has occurred (530). The event is one that may affect a monitored indicator value or a determination as to whether the monitored indicator is indicative of infection. If the event has not occurred within a predetermined time frame) ([0059] predetermined period of time). It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify Lee with Gerber because there is some teaching, suggestion, or motivation to do so. Gerber teaches this “can be used to monitor an infection in proximity to an implanted medical device and which take into account events that may affect the monitored indicator when making a determination as to whether an infection is in proximity to the implanted device” ([0007]).
Lee discloses using a heart rate above 90 bpm to indicate an infection but does not explicitly mention a heart rate above 110% of a mean heart rate at rest. However, the Examiner notes that a typical average resting heart rate of a human adult is approximately 60 bpm, thus making 90 bpm well above 110% of a typical resting heart rate. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to utilize a threshold of at least 110% of a resting heart rate to detect an elevated heart rate, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 10, the combination of Lee and Gerber discloses an arrangement according to claim 9, wherein the data communication unit is arranged and designed to transfer data to the evaluation unit in a wireless manner ([0044] wireless communication, fig 3 telemetry interface 80 must be wireless to communicate from inside the patient to outside).
Regarding claim 11, the combination of Lee and Gerber discloses an arrangement according to claim 9, wherein the first computer- readable program causes the first processor to transmit the body temperature values ([0034] temperature sensor data is transmitted) and the cardiac physiologic parameter values ([0034] atrial sensing) at least once a day ([0032] averaged over time period to smooth out daily variation - implies that daily measurements must be taken).
Regarding claim 12, Lee discloses a non-transitory computer readable medium ([0034] program storage) comprising computer-readable code that causes a processor to perform the following steps when executed on the processor:
storing body temperature values obtained from a temperature sensor of an active implantable medical device ([0034] memory is for data storage and data comprises temperature) and cardiac physiologic parameter values obtained from a detection unit of the same active implantable medical device ([0034] memory is for data storage and data comprises cardiac physiological parameters) in a memory unit of the implantable medical device or of an evaluation unit located outside a body of a person to whom the active implantable medical device is implanted ([0027] device outside patient’s body);
determining that at least one of the body temperature values exceeds a predefined body temperature threshold (check to see if physiological parameters (temperature) have exceeded a particular threshold value [0047]);
classifying an infection of the person as a systemic infection by determining that at least one of the cardiac physiologic parameter values exceeds the predefined cardiac physiologic parameter threshold ([0056] heart rate greater than about 90 beats per minute)
classifying an infection of the person as a local infection by determining that at least one of the cardiac physiological parameter values does not exceed a predefined cardiac physiological parameter threshold (fig 12 yes in step 704 and no in step 708)
wherein the cardiac physiologic parameter is a heart rate or a heart rate at rest([0056]),
wherein the computer-readable program causes the processor to determine an excess of the cardiac physiologic parameter threshold when the heart rate or the heart rate at rest is at least 110% of a mean heart rate([0056] increased heart rate over average, >90 bpm) or a mean heart rate at rest, respectively, over a first number of last days prior to the determining ([0048] setting a time frame), wherein the first number is a number chosen from a range between 3 and 400 ([0049] the actual time period used for changing thresholds can depend on various factors).
wherein when the infection is classified as a systemic infection the patient is classified for treatment in a hospital specialized on the treatment of infectious diseases, and wherein when the infection is classified as a local infection the patient is classified for treatment at a hospital not specialized on the treatment of infectious disease ([0006] use of sensors to monitor for signs of infection, where often these signs of infection are sub-clinical, allowing early intervention, and possibly preventing the need for system explant and subsequently preventing complications – the early intervention is if the infection is identified as local and the system explant is if the infection is identified as systemic, see also the difference in step 506 in fig. 9 and step 606 in fig. 10, see also fig. 12 where an alert or intervention occurs is the infection is systemic and an urgent alert is sent if the infection is systemic, claim 24 treatment threshold).
Lee fails to teach the step of providing advice for which kind of medical center to go to based on the result of the determination. Centers teaches:
h) when the infection is classified as a local infection, providing advice to the person to be examined and/or treated in a hospital or medical center that has performed the implantation of the active implantable medical device (page 7 - some considerations patients should make are “Which hospitals have the best experience with your condition?”, and “Should you consider a specialty hospital…”); and
i) when the infection is classified as a systemic infection, providing advice to the person to contact a hospital or medical center specialized in management and treatment of pandemic diseases (pg. 7 - some considerations patients should make are “Which hospitals have the best experience with your condition?”, and “Should you consider a specialty hospital…”). It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify Lee with Centers because it is well-known and prima facie obvious to select a hospital that is suited to treat the type of infection or disorder a patient has.
Lee discloses that checking temperature and/or heart rate does distinguish between local infections and systemic infections (sepsis) ([0059]) but does not disclose checking temperature first before checking heart rate as required in step f. Before the effective filing date of the claimed invention, it would have been an obvious matter of design choice to a person of ordinary skill in the art to check temperature before heart rate because Applicant has not disclosed that doing so provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected the process of Lee, and applicant' s invention, to perform equally well with either the checking temperature and heart rate at the same time or heart rate first and then temperature as taught by Lee or the claimed checking temperature first and then heart rate because both processes would perform the same function of identifying infection equally well considering both temperature and heart rate, individually, are used to check for infection. The order does not matter. Therefore, it would have been prima facie obvious to modify Lee to obtain the invention as specified in claim 1 because such a modification would have been considered a mere design consideration which fails to patentably distinguish over the prior art of Lee.
Lee discloses using a heart rate above 90 bpm to indicate an infection but does not explicitly mention a heart rate above 110% of a mean heart rate at rest. However, the Examiner notes that a typical average resting heart rate of a human adult is approximately 60 bpm, thus making 90 bpm well above 110% of a typical resting heart rate. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to utilize a threshold of at least 110% of a resting heart rate to detect an elevated heart rate, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Lee fails to teach that the time period of collecting physiological data and the temperature data is the same. Gerber teaches that Tphys and Ttemp are the same ([0059] predetermined period of time). It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify Lee with Gerber because there is some teaching, suggestion, or motivation to do so. Gerber teaches that in order for the infection to be detected, the values must be measured in the same period.
Regarding claim 13, Lee discloses a method for distinguishing between a local infection and a systemic infection of a patient to whom an active implantable medical device has been implanted (fig 12, distinguishing between infection and sepsis), the method comprising the following steps:
repeatedly sensing a body temperature of a patient to whom an active implantable medical device has been implanted with a temperature sensor of the active implantable medical device (temperature changes [0037] - measuring changes implies that it is measured repeatedly), wherein the active implantable medical device further comprises a processor (microprocessor 64), a memory unit (memory 62), and a detection unit (sensors 78) configured to detect a cardiac physiologic parameter (CRM devices [0024], heart rate [0056]);
storing body temperature values ([0034] memory is for data storage and data comprises temperature) obtained in step a) in the memory unit;
repeatedly sensing a cardiac physiologic parameter of the patient ([0056] detecting a trend requires repeated detection);
storing cardiac physiologic parameter values obtained in step c) in the memory unit ([0034] memory is for data storage and data comprises cardiac physiological parameters);
determining that at least one of the body temperature values obtained within time period Ttemp ([0059] predetermined period of time)exceeds a predefined body temperature threshold (check to see if physiological parameters (temperature) have exceeded a particular threshold value [0047]);
classifying an infection of the person as a systemic infection by determining that at least one of the cardiac physiologic parameter values obtained ([0059] predetermined period of time)exceeds a predefined cardiac physiologic parameter threshold ([0056] heart rate greater than about 90 beats per minute), and the body temperature value exceeds the predefined body temperature threshold ([0057] body temperature of greater than 100 degrees Fahrenheit) and classifying an infection of the person as a systemic infection,
classifying an infection of the person as a local infection by determining that at least one of the cardiac physiological parameter values obtained does not exceed the predefined cardiac physiological parameter threshold (infection within pocket 233)
wherein the cardiac physiologic parameter is a heart rate or a heart rate at rest([0056]),
wherein the computer-readable program causes the processor to determine an excess of the cardiac physiologic parameter threshold if the heart rate or the heart rate at rest is at least 110% of a mean heart rate([0056] increased heart rate over average, >90 bpm) or a mean heart rate at rest, respectively, over a first number of last days prior to the determining ([0048] setting a time frame), wherein the first number is a number chosen from a range between 3 and 400 ([0049] the actual time period used for changing thresholds can depend on various factors).
wherein if the infection is classified as a systemic infection the patient is classified for treatment in a hospital specialized on the treatment of infectious diseases, and wherein when the infection is classified as a local infection the patient is classified for treatment at a hospital not specialized on the treatment of infectious disease ([0006] use of sensors to monitor for signs of infection, where often these signs of infection are sub-clinical, allowing early intervention, and possibly preventing the need for system explant and subsequently preventing complications – the early intervention is if the infection is identified as local and the system explant is if the infection is identified as systemic, see also the difference in step 506 in fig. 9 and step 606 in fig. 10, see also fig. 12 where an alert or intervention occurs is the infection is systemic and an urgent alert is sent if the infection is systemic, claim 24 treatment threshold).
Lee fails to teach the step of providing advice for which kind of medical center to go to based on the result of the determination. Centers teaches:
h) when the infection is classified as a local infection, providing advice to the person to be examined and/or treated in a hospital or medical center that has performed the implantation of the active implantable medical device (page 7 - some considerations patients should make are “Which hospitals have the best experience with your condition?”, and “Should you consider a specialty hospital…”); and
i) when the infection is classified as a systemic infection, providing advice to the person to contact a hospital or medical center specialized in management and treatment of pandemic diseases (pg. 7 - some considerations patients should make are “Which hospitals have the best experience with your condition?”, and “Should you consider a specialty hospital…”)
It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify Lee with Centers because it is well-known and prima facie obvious to select a hospital that is suited to treat the type of infection or disorder a patient has.
Lee discloses that checking temperature and/or heart rate does distinguish between local infections and systemic infections (sepsis) ([0059]) but does not disclose checking temperature first before checking heart rate as required in step f or that the temperature and the physiologic parameter. Gerber teaches checking temperature first before checking heart rate in a same time period that the body temperature value exceeds the predefined body temperature threshold as required in step f (fig. 6 – parts 520 and 540, [0055] whether a value associated with the monitored information has crossed a first threshold indicative of infection (520). For example, processor 110 may compare a value associated with the monitored indicator to a value in a look-up table stored in memory 120 (see, e.g. FIG. 7) to determine whether the first threshold is crossed. If the first threshold is not crossed, the indicator of infection may continue to be monitored (500). If the threshold is crossed, a determination may be made as to whether an event associated with the device has occurred (530). The event is one that may affect a monitored indicator value or a determination as to whether the monitored indicator is indicative of infection. If the event has not occurred within a predetermined time frame). Gerber teaches that Tphys and Ttemp overlap ([0059] predetermined period of time). It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify Lee with Gerber because there is some teaching, suggestion, or motivation to do so. Gerber teaches this “can be used to monitor an infection in proximity to an implanted medical device and which take into account events that may affect the monitored indicator when making a determination as to whether an infection is in proximity to the implanted device” ([0007]).
Lee discloses using a heart rate above 90 bpm to indicate an infection but does not explicitly mention a heart rate above 110% of a mean heart rate at rest. However, the Examiner notes that a typical average resting heart rate of a human adult is approximately 60 bpm, thus making 90 bpm well above 110% of a typical resting heart rate. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to utilize a threshold of at least 110% of a resting heart rate to detect an elevated heart rate, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 14, Lee discloses the method according to claim 13, wherein the method further comprises deciding to examine and/or treat the patient in a hospital specialized on the treatment of infectious diseases ([0059] take immediate medical action at step 710) if the infection of the patient has been classified as systemic infection([0059] if sepsis is detected).
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being obvious in view of Lee et al (US20080064980A1); hereinafter Lee and the Centers for Medicare and Medicaid Services Guide to Choosing a Hospital (https://www.tha.org/wp-content/uploads/2024/04/Guide-to-Choosing-a-Hospital.pdf) (cited previously). Lee fails to teach that the hospital selected in claim 14 is specialized on the treatment of a particular disease. However, it would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to select a hospital particular to a disease as it is well-known and prima facie obvious to select a hospital that is suited to treat the type of infection or disorder a patient has. The Centers of Medicare and Medicaid Services have an official government booklet providing guidance to patients on how to select the best hospital for their care and among the checklist provided on page 7, some considerations patients should make are “Which hospitals have the best experience with your condition?”, and “Should you consider a specialty hospital…”. Therefore, selecting a hospital that specializes in COVID-19 or any particular disease is well-known and obvious.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Dhrasti SNEHAL Dalal whose telephone number is (571)272-0780. The examiner can normally be reached Monday - Thursday 8:30 am - 6:00 pm, Alternate Friday off, 8:30 am - 5:00 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Carl Layno can be reached at (571) 272-4949. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/D.S.D./Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796