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 Amendments
Applicant's amendments and remarks, filed 12/18/2025, are acknowledged. Applicant's arguments have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. Rejections and/or objections not reiterated from the previous office actions are hereby withdrawn.
Status of Claims
Claims 1, 27-32, 39, 40, 57, 81-85 are currently under examination.
Priority
This application is a divisional of US Application No 17921245, filed 10/25/2022, now Patent No 11896352, which was a national stage entry under §371 of the international application PCT/US2021/030210 which was filed on 04/30/2021.
Applicant’s claim for the benefit of priority under 35 U.S.C. 119(e) to provisional application 62/706,597, filed 08/27/2020, 62/705,613, filed 07/07/2020, 62/704,954, filed 06/04/2020 and 63/017,942, filed 04/30/2020 are acknowledged.
Withdrawn Objections/Rejections
The rejection of claim 39 under 35 U.S.C. 112(b) is withdrawn in view of applicant’s arguments and/or amendments.
Response to Arguments
Applicant’s responses and arguments filed 12/18/2025 regarding claim rejections under 35 USC 103 have been fully considered.
Applicant amended the independent claims with subject matter not previously prosecuted and changing the scope of the claims therefore necessitating new grounds of rejection.
The Applicant is arguing that the references of record are not teaching the amended limitations in the independent claims.
In response, the examiner is considering the arguments as moot since they are directed to amended limitations changing the scope of the claims and necessitating new grounds of rejection. The examiner is considering new references for addressing the amended limitations.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, 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.
Claims 1, 27-30, 39, 40, 57, 81-83 are rejected under 35 U.S.C. 103 as being unpatentable over Kalafut et al. (USPN 20100114064 A1; Pub.Date 05/06/2010; Fil.Date 11/03/2009) in view of Singh et al. (2008 J. Nucl. Med. Technol. 36:69–74; Pub.Date 2018) in view of Gujral et al. (USPN 20190328339 A1; Pub.Date 10/31/2019; Fil.Date 06/29/2018), in view of Mitra (USPN 20210196168 A1; Pub.Date 07/01/2021; Fil.Date 02/17/2017) in view of Aung et al. (USPN 20170340257 A1; Pub.Date 11/30/2017; Fil.Date 12/23/2015) in view of Tsunomori et al. (USPN 20170325771 A1; Pub.Date 11/16/2017; Fil.Date 04/26/2017) in view of Kamada (USPN 20110181286 A1; Pub.Date 07/08/2011; Fil.Date 10/02/2009).
Regarding claim 1, Kalafut teaches a system and method to use it (Title and abstract) comprising:
at least one processor programmed and/or configured to (Fig. 3 processor within a network and Fig. 6 [0089] processing system/control system and [0071] “CIN risk assessment system 300 is, for example, a computer-based system that can, for example, estimate the risk of CIN in a patient before a contrast based imaging or therapeutic procedure is performed. In the depicted embodiment of CIN risk assessment system 300, a CIN risk assessment algorithm or program resides, for example, on a computer system 310 that is operably connected to a computer network", CIN being "contrast induced nephropathy" and the CIN risk assessment is interpreted broadly as the determination a probability that the patient will suffer of CIN as in [0086] “These embodiments of the systems and methods of the present invention can be used in both minimizing the probability of CIN and to provide a personalized treatment and/or a prophylactic paradigm as necessary”):
obtain patient data associated with the patient ([0072]-0073] “a CIN risk assessment computer program has information inputs including, but is not limited to: patient past history of contrast usage, if pre-existing renal insufficiency exists, if diabetes exists, age, if the patient is concurrently using nephrotoxic drugs, hydration level, blood pressure, if previous heart failure exists, if contrast allergy exists, if cirrhosis exists, if nephritic syndrome exists, height, weight, body surface area (BSA), creatinine level, body mass index (BMI), blood urea nitrogen (BUN), Kidney Injury Marker 1 & 2, cardiac output, recent urine volume, planned contrast based imaging procedure, and planned contrast type to be used" and Fig. 6 for displaying “patient data”);
determine, based on the patient data, an initial risk prediction for the patient associated with a fluid injection to be administered to the patient, wherein the initial risk prediction includes a probability that the patient experiences at least one adverse event in response to the fluid injection ([0020] system with methods including patient risk assessment with treatment of contrast induced physiological reactions during a medical procedure, and Fig. 3 and 5A and [0071] “Before a contrast-enhanced imaging or therapeutic procedure is performed the risk of CIN is desirably assessed. One source for accessing the risk of CIN is from the medical history and/or the results of lab tests for the patient. This assessment risk information source may, for example, result in limiting the maximum amount of contrast the patient may be given or serve as a guide to recommend an appropriate amount of contrast for the patient. CIN risk assessment system 300 is, for example, a computer-based system that can, for example, estimate the risk of CIN in a patient before a contrast based imaging or therapeutic procedure is performed” and [0073] “risk assessment computer program takes the various informational inputs just described and, based on algorithms and/or one or more reference table(s) of past empirical data, provides output, including, for example, an objective CIN risk factor for the patient" and “may also be extended to include patient-specific information on patient disease state, treatment history, physiologic state, contrast dosing history (described further herein) or other patient related parameters or factors that impact the potential risk of CIN or other adverse events”);
provide, to a user device, before the fluid injection is administered to the patient, the initial risk prediction ([0073] and Fig. 2 “CIN risk assessment system 300 can, for example, output CIN risk assessment information on, for example, a display screen associated with computer device 240”);
determine, using at least one sensor, sensor data associated with the patient and determined after the fluid injection is started ([0077] “Another way to minimize the risk and incidence (CIN) is to monitor the real-time contrast load in the patient, which is the dose of contrast that still remains systemically within a patient's body, before, during, or after contrast agent administration” for monitoring the patient and sensor data including Fig. 5A “extract GFR information” “serum creatinine measurement and BUN” and [0077] “a portable chemistry analyzing device is provided for determining the level of level of blood urea nitrogen (BUN), creatinine, or combinations thereof in the biological fluid sample, with this device residing locally in the control room area of an imaging suite. Such a device may use in CIN risk assessment system 300 for contrast load assessment during an imaging procedure”)
determine, based on the sensor data determined after the fluid injection is started, a current risk prediction for the patient associated with the fluid injection, wherein the current risk prediction includes a probability that the patient experiences the at least one adverse event in response to the fluid injection (Fig. 5A “Serum Creatinine Measurement, BUN” and “Extract GFR Information” leading to “CIN risk assessment” during fluid injection with the stage F with [0095] “ At this point another CIN risk assessment C(d) can occur at least in part on the basis of GFR information extracted from the enhancement curve” in regard to the previous risk assessment to minimize as in [0086] “These embodiments of the systems and methods of the present invention can be used in both minimizing the probability of CIN” from the initial risk/probability as in [0087] “A better prognosticator of CIN risk than serum creatinine level or BUN alone is the glomerular filtration rate. An initial estimate of GFR may, for example, be made by consulting standard look-up tables that treat serum creatinine as an independent parameter along with, for example, BMI, age, and sex” to the current risk/probability as in [0095] stage F); and
provide, to the user device, the current risk prediction ([0079] “During and after the procedure, for example, the clinician may be provided with real-time feedback or a recommended course of treatment or information on recommended medications to be administered to treat the high contrast dose” with Fig. 6 with displaying CIN risk analysis results below patient data).
Kalafut does not teach specifically determine, based on the sensor data determined after the fluid injection is started, a patient distress level; and provide, to the user device, the patient distress level; and automatically control, based on the patient distress level, at least one of the following: a haptic device to produce a haptic output that is feelable by the patient, a speaker to produce an audible output that is hearable by the patient, a display to produce a visible output that is viewable by the patient, or any combination thereof, to guide breathing of the patient, wherein at least one of the haptic output, the audible output, the visible output, or any combination thereof includes instructions for guiding breathing of the patient, and adjust, based on a timing of an imaging operation of an imaging system, the at least one of the haptic output, the audible output, the visible output, or any combination thereof that includes the instructions for guiding breathing of the patient by: (i) in response to determining that the imaging system is actively imaging the patient, automatically adjusting the instructions to instruct the patient to hold the patient's breath and providing an indication to let the patient know when the patient may breathe again; and (ii) in response to determining that the imaging operation has ended or has been paused, automatically adjusting the instructions to indicate that the patient is able to breathe out as in claim 1.
However, Singh teaches within the same field of endeavor of managing contrast iodinated contrast media injection in patient for medical diagnostics (Title and abstract) the adverse reactions which can occur with this contrast agent injection in patient, especially with predisposed patients (p.70 col.2 2nd ¶) with additional anxiety and apprehension to amplify the patient physiological response which can be assess using sensors (as reported in Table 4 and Table 5 with mitigation) with patient presenting persistent burning and swelling at the injection site with possible swelling, pain and discoloration requiring surgical attention or mitigation (p72 col.1 2nd ¶). Additionally, Gujral teaches within the same field of endeavor for monitoring pain and distress (Title and abstract) the use of sensors for biometric signal acquisition to determine distress level in a patient and to communicating it via notifications to specific recipient/remote device (abstract and [0008] heart rate, local temperatures or imaging to provide scores as in [0018] and [0064]-[0067] Fig.5 for the determination of the distress level if that level exceed a threshold), therefore teaching determine, based on the sensor data determined after the fluid injection is started, a patient distress level; and provide, to the user device, the patient distress level .
Therefore it would have been obvious for a person of ordinary skill in the art before the effective filling date of the invention to have modified the system of Kalafut such that the system further comprises: determine, based on the sensor data determined after the fluid injection is started, a patient distress level; and provide, to the user device, the patient distress level, since one of ordinary skill in the art would recognize that combining sensors data for assessing the physiological response of the patient to iodinated contrast media injection was known in the art as taught by Singh and since consequently determining the level of distress or pain in the patient using sensors was also known in the art as taught by Gujral. One of ordinary skill in the art would have expected that this modification could have been made with predictable results since Kalafut and Singh teach using of iodinated contrast in patient for diagnostics and Singh and Gujral teach the presence of pain/distress in patients. The motivation would have been to monitor and mitigate the occurrence of distress in the patient to minimize the secondary effects of the treatments, as suggested by Singh (Tables 4 and 5).
Additionally, Mitra teaches within the same field of endeavor and concern about measuring emotional state level (Title and abstract) the use of emotional sensoring (abstract and [0033]) with the automated sensory feedback ([0029]) wherein consequently to a transitional emotional state a sensory feedback is provided ([0090]-[0093]) via “a friendly nudge or pat in real time, a speaker providing a supporting sound, such as a hurray, a sigh or the like, a display or light showing a supporting text message, picture or color, or the like” ([0093] such as visual, textual, sound, haptic, taste and/or olfactory signal). Additionally, Aung teaches within the same field of endeavor of responding to the distress of a user (Title and abstract and [0005] affecting breathing) the use of audible and visual breathing instructions via a display to assist an individual to relax ([0096]) therefore in combination with Mitra automatically control, based on the patient distress level, at least one of the following: a haptic device to produce a haptic output that is feelable by the patient, a speaker to produce an audible output that is hearable by the patient, a display to produce a visible output that is viewable by the patient, or any combination thereof, to guide breathing of the patient, wherein at least one of the haptic output, the audible output, the visible output, or any combination thereof includes instructions for guiding breathing of the patient as claimed.
Therefore it would have been obvious for a person of ordinary skill in the art before the effective filling date of the invention to have modified the system of Kalafut as modified by Singh and Gujral such that the system further comprises: automatically control, based on the patient distress level, at least one of the following: a haptic device to produce a haptic output that is feelable by the patient, a speaker to produce an audible output that is hearable by the patient, a display to produce a visible output that is viewable by the patient, or any combination thereof, to guide breathing of the patient, wherein at least one of the haptic output, the audible output, the visible output, or any combination thereof includes instructions for guiding breathing of the patient, since one of ordinary skill in the art would recognize that using an emotional sensoring system for assessing the emotional level of the subject and consequently automatically providing an emotional feedback to the subject were known in the art as taught by Mitra and since determining the level of distress or pain in the patient using sensors was also known in the art as taught by Gujral and since providing instruction for the patient via a display/screen with audio and visual breathing instruction for the patient to relax was also known in the art as taught by Aung. One of ordinary skill in the art would have expected that this modification could have been made with predictable results since Mitra and Gujral both are teaching the evaluation of the emotional/stress level of a subject with Aung teaching a solution for the patient. The motivation would have been to continuously monitor and mitigate the transitional emotional stress of the subject to improve the subject treatment, as suggested by Mitra ([0090]-[0093]) and Aung ([0096]).
Kalafut, Singh, Gujral, Mitra and Aung do not specifically teach to adjust, based on a timing of an imaging operation of an imaging system, the at least one of the haptic output, the audible output, the visible output, or any combination thereof that includes the instructions for guiding breathing of the patient by: (i) in response to determining that the imaging system is actively imaging the patient, automatically adjusting the instructions to instruct the patient to hold the patient's breath and providing an indication to let the patient know when the patient may breathe again; and (ii) in response to determining that the imaging operation has ended or has been paused, automatically adjusting the instructions to indicate that the patient is able to breathe out as in claim 1.
However, Tsunomori teaches within the same field of endeavor of imaging patient with perfusion (Title and abstract) the use of breathing instructions for adjusting the breathing of the patient with breath-hold session while imaging part of the patient’s body using an imaging system with a screen/display providing the timing for the patient to breath for respiratory guidance for ([0009]-[0011] and [0059] for controlling the imaging including the breathing instructions during timings for the dynamic imaging procedure) therefore teaching to adjust, based on a timing of an imaging operation of an imaging system, the at least one of the haptic output, the audible output, the visible output, or any combination thereof that includes the instructions for guiding breathing of the patient as claimed. Additionally, Tsunomori teaches ([0059]) starting the sequence for dynamic imaging with then providing a respiratory guidance indicator such as sound or display indication such as “breath in”, “breath out” “hold it” therefore additionally teaching by: (i) in response to determining that the imaging system is actively imaging the patient, automatically adjusting the instructions to instruct the patient to hold the patient's breath and providing an indication to let the patient know when the patient may breathe again. Similarly Kamada teaches within the same field of endeavor of medical imaging (Title and abstract) the performance of breath-holding during imaging wherein instructions automatically are provided to the patient to perform starting or stopping breath-holding according to the imaging planning and to stop the breath-holding when the imaging sequence ended, therefore teaching breath holding as and (ii) in response to determining that the imaging operation has ended or has been paused, automatically adjusting the instructions to indicate that the patient is able to breathe out as claimed.
Therefore it would have been obvious for a person of ordinary skill in the art before the effective filling date of the invention to have modified the system of Kalafut as modified by Singh, Gujral, Mitra and Aung such that the system further comprises: to adjust, based on a timing of an imaging operation of an imaging system, the at least one of the haptic output, the audible output, the visible output, or any combination thereof that includes the instructions for guiding breathing of the patient by: (i) in response to determining that the imaging system is actively imaging the patient, automatically adjusting the instructions to instruct the patient to hold the patient's breath and providing an indication to let the patient know when the patient may breathe again; and (ii) in response to determining that the imaging operation has ended or has been paused, automatically adjusting the instructions to indicate that the patient is able to breathe out, since one of ordinary skill in the art would recognize that instructing the patient with breathing control commands via a display/screen or other means for controlling the patient breathing according to the timing of the imaging procedure was known in the art as taught by Tsunomori and Kamada. One of ordinary skill in the art would have expected that this modification could have been made with predictable results since Tsunomori, Kamada, Mitra and Aung are teaching the use of a screen/display and sound for instructing the patient to follow a given breathing pattern. The motivation would have been to have the patient to be able to control his breathing according to the requirement of the imaging conditions, as suggested by Tsunomori and Kamada.
Regarding the dependent claims 27-30, all the elements of these claims are instantly disclosed or fully envisioned by the teaching of Kalafut, Singh, Gujral, Mitra, Aung, Tsunomori and Kamada.
Regarding claim 27, as discussed for claim 1, Gujral teaches the determination of the patient distress level an comparing it to a threshold ([0064]-[0067] Fig.5 for the determination of the distress level if that level exceed a threshold, to send a notification or alert that the level exceed a threshold ([0061])) wherein Kalafut teaches also an automatically control, based on the current risk prediction, at least one of: (i) a fluid injection system to stop the fluid injection; and (ii) an imaging system to adjust a timing of an imaging operation (Fig. 5A “unacceptable CIN risk assessment” leading to stop the injection, [0091] “ If it is determined that there is an unacceptable risk of CIN, the procedure can be stopped” and [0077] “This real-time contrast load may, for example, be used as a parameter or informational input to the CIN risk assessment system 300 and, more particularly, the algorithm residing in computer system 310 (and/or computer device 240 in system 200 of FIG. 2) to control or modify the imaging procedure” and [0093] “Scanner parameters that can be determined include, but are not limited to, the amount of radiation transmitted to the patient, power inputs (for example, voltage or current), timing (for example, scan start time, stop time, delay time and/or duration)”) therefore teaching wherein the at least one processor is further programmed and/or configured to: compare the patient distress level to at least one threshold level; and in response to determining that the patient distress level satisfies the at least one threshold level, at least one of: provide, to a user device, an alert; and automatically control at least one of: (i) a fluid injection system to stop the fluid injection; and (ii) an imaging system to adjust a timing of an imaging operation as claimed.
Regarding claim 28, as discussed above for claim 27, Gujral teaches the change of the distress level with time ([0064]-[0067] and Fig.5) therefore teaching determining a change in one or more parameters of the sensor data over a period of time, and comparing the change in the one or more parameters to at least one threshold change as claimed.
Regarding claim 29, as discussed above for claim 1, Singh presents some different parameters for quantifying the secondary effects of the iodinated contrast media injection such as a temperature at the injection site, a heart rate, oxygenation (p.71 col.1 6th ¶ temperature and Table 4 and 5 for heart rate and oxygenation) therefore teaching the sensor data includes at least one of the following parameters associated with the patient: a heart rate, an oxygen saturation, a skin resistivity, a skin color, a movement level, a temperature proximate an injection site, or any combination thereof as claimed.
Regarding claim 30, as discussed above for claim 29, Singh teaches the monitoring of the temperature at the injection site and oxygen saturation (p.71 col.1 6th ¶ temperature and Table 4 and 5 for heart rate and oxygenation) therefore teaching a pulse oximeter, a skin resistance sensor, a skin color sensor, an accelerometer, a temperature sensor, or any combination thereof as claimed.
Regarding independent claim 39, claim 39 is directed to a system as such Kalafut teaches a system and method to use it (Title and abstract) comprising: at least one sensor configured to determine sensor data associated with a patient at least one of before, during, and after a fluid injection associated with the patient ([0077] “Another way to minimize the risk and incidence (CIN) is to monitor the real-time contrast load in the patient, which is the dose of contrast that still remains systemically within a patient's body, before, during, or after contrast agent administration” for monitoring the patient and sensor data including Fig. 5A “extract GFR information” “serum creatinine measurement and BUN” and [0077] “a portable chemistry analyzing device is provided for determining the level of level of blood urea nitrogen (BUN), creatinine, or combinations thereof in the biological fluid sample, with this device residing locally in the control room area of an imaging suite. Such a device may use in CIN risk assessment system 300 for contrast load assessment during an imaging procedure”)
at least one processor programmed and/or configured to (Fig. 3 processor within a network and Fig. 6 [0089] processing system/control system and [0071] “CIN risk assessment system 300 is, for example, a computer-based system that can, for example, estimate the risk of CIN in a patient before a contrast based imaging or therapeutic procedure is performed. In the depicted embodiment of CIN risk assessment system 300, a CIN risk assessment algorithm or program resides, for example, on a computer system 310 that is operably connected to a computer network", CIN being "contrast induced nephropathy" and the CIN risk assessment is interpreted broadly as the determination a probability that the patient will suffer of CIN as in [0086] “These embodiments of the systems and methods of the present invention can be used in both minimizing the probability of CIN and to provide a personalized treatment and/or a prophylactic paradigm as necessary”).
Kalafut does not specifically teach determine, based on the sensor data, a wellbeing level of the patient at least one of before, during, and during the fluid injection; and provide, to a user device, the wellbeing level of the patient and automatically control, based on the wellbeing level of the patient, at least one of the following: a haptic device to produce a haptic output that is feelable by the patient, a speaker to produce an audible output that is hearable by the patient, a display to produce a visible output that is viewable by the patient, or any combination thereof, to guide breathing of the patient, wherein at least one of the haptic output, the audible output, the visible output, or any combination thereof includes instructions for guiding breathing of the patient; and adjust, based on a timing of an imaging operation of an imaging system, the at least one of the haptic output, the audible output, the visible output, or any combination thereof that includes the instructions for guiding breathing of the patient as in claim 39.
However, Singh teaches within the same field of endeavor of managing contrast iodinated contrast media injection in patient for medical diagnostics (Title and abstract) the adverse reactions which can occur with this contrast agent injection in patient, especially with predisposed patients (p.70 col.2 2nd ¶) with additional anxiety and apprehension to amplify the patient physiological response which can be assess using sensors (as reported in Table 4 and Table 5 with mitigation) with patient presenting persistent burning and swelling at the injection site with possible swelling, pain and discoloration requiring surgical attention or mitigation (p72 col.1 2nd ¶). Additionally, Gujral teaches within the same field of endeavor for monitoring pain and distress (Title and abstract) the use of sensors for biometric signal acquisition to determine distress level in a patient and to communicating it via notifications to specific recipient/remote device (abstract and [0008] heart rate, local temperatures or imaging to provide scores as in [0018] and [0064]-[0067] Fig.5 for the determination of the distress level if that level exceed a threshold). Gujral teaches also to provide management strategies to minimize the threats from those induced distress factors (p.74 col.1 3rd ¶). The examiner therefore notes that the distress level has the opposite definition than the wellbeing level of the patient. Since Gujral teaches the distress level is defined for the sensor data being below the fixed threshold separating the distress range from the wellbeing range for the patient for which the Gujral device does not provide an alert or warning therefore Singh and Gujral are found to obviously teach determine, based on the sensor data, a wellbeing level of the patient at least one of before, during, and during the fluid injection; and provide, to a user device, the wellbeing level of the patient as claimed.
Therefore it would have been obvious for a person of ordinary skill in the art before the effective filling date of the invention to have modified the system of Kalafut such that the system further comprises: determine, based on the sensor data, a wellbeing level of the patient at least one of before, during, and during the fluid injection; and provide, to a user device, the wellbeing level of the patient, since one of ordinary skill in the art would recognize that combining sensors data for assessing the physiological response of the patient to iodinated contrast media injection was known in the art as taught by Singh and since one of ordinary skill in the art would consider that the same threshold below which the determined level from the sensor data defines a distress region will be the same threshold above which the determined level of the sensor data would define a wellbeing region for the patient, therefore the level of wellbeing would be obviously known in the art as taught by Gujral defining the level of the sensor data defining a distress for the patient. One of ordinary skill in the art would have expected that this modification could have been made with predictable results since Kalafut and Singh teach using of iodinated contrast in patient for diagnostics and Singh and Gujral teach the presence or absence of pain/distress in patients. The motivation would have been to monitor wellbeing of the patient for optimizing the injection rate for the patient, as suggested by Singh (Tables 4 and 5).
Additionally, Mitra teaches within the same field of endeavor and concern about measuring emotional state level (Title and abstract) the use of emotional sensoring (abstract and [0033]) with the automated sensory feedback ([0029]) wherein consequently to a transitional emotional state a sensory feedback is provided ([0090]-[0093]) via “a friendly nudge or pat in real time, a speaker providing a supporting sound, such as a hurray, a sigh or the like, a display or light showing a supporting text message, picture or color, or the like” ([0093] such as visual, textual, sound, haptic, taste and/or olfactory signal) Additionally, Aung teaches within the same field of endeavor of responding to the distress of a user (Title and abstract and [0005] affecting breathing) the use of audible and visual breathing instructions via a display to assist an individual to relax ([0096]) therefore in combination with Mitra automatically control, based on the patient distress level, at least one of the following: a haptic device to produce a haptic output that is feelable by the patient, a speaker to produce an audible output that is hearable by the patient, a display to produce a visible output that is viewable by the patient, or any combination thereof, to guide breathing of the patient, wherein at least one of the haptic output, the audible output, the visible output, or any combination thereof includes instructions for guiding breathing of the patient as claimed.
Therefore it would have been obvious for a person of ordinary skill in the art before the effective filling date of the invention to have modified the system of Kalafut as modified by Singh and Gujral such that the system further comprises: automatically control, based on the patient distress level, at least one of the following: a haptic device to produce a haptic output that is feelable by the patient, a speaker to produce an audible output that is hearable by the patient, a display to produce a visible output that is viewable by the patient, or any combination thereof, to , to guide breathing of the patient, wherein at least one of the haptic output, the audible output, the visible output, or any combination thereof includes instructions for guiding breathing of the patient, since one of ordinary skill in the art would recognize that using an emotional sensoring system for assessing the emotional level of the subject and consequently automatically providing an emotional feedback to the subject were known in the art as taught by Mitra and since determining the level of distress or pain in the patient using sensors was also known in the art as taught by Gujral and since providing instruction for the patient via a display/screen with audio and visual breathing instruction for the patient to relax was also known in the art as taught by Aung. One of ordinary skill in the art would have expected that this modification could have been made with predictable results since Mitra and Gujral both are teaching the evaluation of the emotional/stress level of a subject with Aung teaching a solution for the patient. The motivation would have been to continuously monitor and mitigate the transitional emotional stress of the subject to improve the subject treatment, as suggested by Mitra ([0090]-[0093]) and Aung ([0096]).
Kalafut, Singh, Gujral, Mitra and Aung do not specifically teach to adjust, based on a timing of an imaging operation of an imaging system, the at least one of the haptic output, the audible output, the visible output, or any combination thereof that includes the instructions for guiding breathing of the patient by: (i) in response to determining that the imaging system is actively imaging the patient, automatically adjusting the instructions to instruct the patient to hold the patient's breath and providing an indication to let the patient know when the patient may breathe again; and (ii) in response to determining that the imaging operation has ended or has been paused, automatically adjusting the instructions to indicate that the patient is able to breathe out as in claim 1.
However, Tsunomori teaches within the same field of endeavor of imaging patient with perfusion (Title and abstract) the use of breathing instructions for adjusting the breathing of the patient with breath-hold session while imaging part of the patient’s body using an imaging system with a screen/display providing the timing for the patient to breath for respiratory guidance for ([0009]-[0011] and [0059] for controlling the imaging including the breathing instructions during timings for the dynamic imaging procedure) therefore teaching to adjust, based on a timing of an imaging operation of an imaging system, the at least one of the haptic output, the audible output, the visible output, or any combination thereof that includes the instructions for guiding breathing of the patient as claimed. Additionally, Tsunomori teaches ([0059]) starting the sequence for dynamic imaging with then providing a respiratory guidance indicator such as sound or display indication such as “breath in”, “breath out” “hold it” therefore additionally teaching by: (i) in response to determining that the imaging system is actively imaging the patient, automatically adjusting the instructions to instruct the patient to hold the patient's breath and providing an indication to let the patient know when the patient may breathe again. Similarly Kamada teaches within the same field of endeavor of medical imaging (Title and abstract) the performance of breath-holding during imaging wherein instructions automatically are provided to the patient to perform starting or stopping breath-holding according to the imaging planning and to stop the breath-holding when the imaging sequence ended, therefore teaching breath holding as and (ii) in response to determining that the imaging operation has ended or has been paused, automatically adjusting the instructions to indicate that the patient is able to breathe out as claimed.
Therefore it would have been obvious for a person of ordinary skill in the art before the effective filling date of the invention to have modified the system of Kalafut as modified by Singh, Gujral, Mitra and Aung such that the system further comprises: to adjust, based on a timing of an imaging operation of an imaging system, the at least one of the haptic output, the audible output, the visible output, or any combination thereof that includes the instructions for guiding breathing of the patient by: (i) in response to determining that the imaging system is actively imaging the patient, automatically adjusting the instructions to instruct the patient to hold the patient's breath and providing an indication to let the patient know when the patient may breathe again; and (ii) in response to determining that the imaging operation has ended or has been paused, automatically adjusting the instructions to indicate that the patient is able to breathe out, since one of ordinary skill in the art would recognize that instructing the patient with breathing control commands via a display/screen or other means for controlling the patient breathing according to the timing of the imaging procedure was known in the art as taught by Tsunomori and Kamada. One of ordinary skill in the art would have expected that this modification could have been made with predictable results since Tsunomori, Kamada, Mitra and Aung are teaching the use of a screen/display and sound for instructing the patient to follow a given breathing pattern. The motivation would have been to have the patient to be able to control his breathing according to the requirement of the imaging conditions, as suggested by Tsunomori and Kamada.
Regarding independent claim 40, as discussed above for independent claim 39, Kalafut, Singh, Gujral, Mitra, Aung, Tsunomori and Kamada teach a system comprising: at least one processor programmed and/or configured to: obtain sensor data associated with the patient and determined after a fluid injection associated with the patient is started; determine, based on the sensor data determined after the fluid injection is started, a wellbeing level of the patient during the fluid injection; provide, to a user device, the wellbeing level of the patient and automatically control, based on the wellbeing level of the patient, at least one of the following: a haptic device to produce a haptic output that is feelable by the patient, a speaker to produce an audible output that is hearable by the patient, a display to produce a visible output that is viewable by the patient, or any combination thereof, to guide breathing of the patient, wherein at least one of the haptic output, the audible output, the visible output, or any combination thereof includes instructions for guiding breathing of the patient; and adjust, based on a timing of an imaging operation of an imaging system, the at least one of the haptic output, the audible output, the visible output, or any combination thereof that includes the instructions for guiding breathing of the patient. Additionally, Kalafut teaches also an automatically control, based on the current sensor data analysis an imaging system to adjust a timing of an imaging operation (Fig. 5A “unacceptable CIN risk assessment” leading to stop the injection, [0091] “ If it is determined that there is an unacceptable risk of CIN, the procedure can be stopped” and [0077] “This real-time contrast load may, for example, be used as a parameter or informational input to the CIN risk assessment system 300 and, more particularly, the algorithm residing in computer system 310 (and/or computer device 240 in system 200 of FIG. 2) to control or modify the imaging procedure” and [0093] “Scanner parameters that can be determined include, but are not limited to, the amount of radiation transmitted to the patient, power inputs (for example, voltage or current), timing (for example, scan start time, stop time, delay time and/or duration)”) wherein the wellbeing level of the patient is directly related to the distress level of the patient as discussed above, therefore Kalafut is teaching an automatically control, based on the wellbeing level of the patient, at least one of: (i) a fluid injection system to adjust at least one of a maximum flow rate, a maximum pressure, an injection duration, a total volume of fluid, or any combination thereof, of the fluid injection; and (ii) an imaging system to adjust a timing of an imaging operation. Therefore Kalafut, Singh, Gujral, Mitra, Aung, Tsunomori and Kamada teach independent claim 40.
Regarding independent claim 57, claim 57 is directed to a method reciting the functional limitations of the claimed system of claim 1 and of claim 27. Since Kalafut, Singh, Gujral, Mitra, Aung, Tsunomori and Kamada teach independent claim 1 and dependent claim 27, therefore, claim 57 is therefore made obvious by the teachings of Kalafut, Singh, Gujral, Mitra, Aung, Tsunomori and Kamada discussed above mutandis mutatis.
Regarding the dependent claims 81-83 from independent claim 57, all the elements of these claims are instantly disclosed or fully envisioned by the teaching of Kalafut, Singh, Gujral, Mitra, Aung, Tsunomori and Kamada.
Regarding claim 81, as discussed above for claim 57 with claim 1 and 27, Gujral teaches the change of the distress level with time ([0064]-[0067] and Fig.5) therefore teaching determining a change in one or more parameters of the sensor data over a period of time, and comparing the change in the one or more parameters to at least one threshold change as claimed.
Regarding claim 82, as discussed above for claim 57 with claim 1, Singh presents some different parameters for quantifying the secondary effects of the iodinated contrast media injection such as a temperature at the injection site, a heart rate, oxygenation (p.71 col.1 6th ¶ temperature and Table 4 and 5 for heart rate and oxygenation) therefore teaching the sensor data includes at least one of the following parameters associated with the patient: a heart rate, an oxygen saturation, a skin resistivity, a skin color, a movement level, a temperature proximate an injection site, or any combination thereof as claimed.
Regarding claim 83, as discussed above for claim 82, Singh teaches the monitoring of the temperature at the injection site and oxygen saturation (p.71 col.1 6th ¶ temperature and Table 4 and 5 for heart rate and oxygenation) therefore teaching a pulse oximeter, a skin resistance sensor, a skin color sensor, an accelerometer, a temperature sensor, or any combination thereof as claimed.
Claims 31, 84 are rejected under 35 U.S.C. 103 as being unpatentable over Kalafut et al. (USPN 20100114064 A1; Pub.Date 05/06/2010; Fil.Date 11/03/2009) in view of Singh et al. (2008 J. Nucl. Med. Technol. 36:69–74; Pub.Date 2018) in view of Gujral et al. (USPN 20190328339 A1; Pub.Date 10/31/2019; Fil.Date 06/29/2018) in view of Mitra (USPN 20210196168 A1; Pub.Date 07/01/2021; Fil.Date 02/17/2017) in view of Aung et al. (USPN 20170340257 A1; Pub.Date 11/30/2017; Fil.Date 12/23/2015) in view of Tsunomori et al. (USPN 20170325771 A1; Pub.Date 11/16/2017; Fil.Date 04/26/2017) in view of Kamada (USPN 20110181286 A1; Pub.Date 07/08/2011; Fil.Date 10/02/2009) as applied to claim 27 and claim 57 and further in view of Delia (USPN 20160310085 A1; Pub.Date 10/27/2016; Fil.Date 04/21/2016).
Kalafut, Singh, Gujral, Mitra, Aung, Tsunomori and Kamada teach a system as set forth above. As discussed above, Kalafut, Singh, Gujral, Mitra, Aung and Tan teach a sensor device with different sensor elements therefore teaching a sensor device, wherein the at least one sensor is included in the sensor device.
Kalafut, Singh, Gujral, Mitra, Aung, Tsunomori and Kamada do not specifically teach, wherein the sensor device includes a glove shaped housing configured to be worn on a hand of the patient, wherein the housing includes the at least one sensor and a wireless communication device, and wherein the wireless communication device is configured to wirelessly transmit the sensor data to an external device as in claim 31 and claim 84.
However, Delia teaches within the same field of endeavor of medical examination device (Title and abstract) the design of a glove including a pulse oximeter ([0039]) as part of a glove housing comprising hardware for sending signals/data from the sensor devices via wireless communication for remote access and analysis ([0004], [0039], Fig. 3 and 5 with element 12) therefore teaching wherein the sensor device includes a glove shaped housing configured to be worn on a hand of the patient, wherein the housing includes the at least one sensor and a wireless communication device, and wherein the wireless communication device is configured to wirelessly transmit the sensor data to an external device as claimed.
Therefore it would have been obvious for a person of ordinary skill in the art before the effective filling date of the invention to have modified the system of Kalafut as modified by Singh, Gujral, Mitra, Aung, Tsunomori and Kamada such that the system further comprises: wherein the sensor device includes a glove shaped housing configured to be worn on a hand of the patient, wherein the housing includes the at least one sensor and a wireless communication device, and wherein the wireless communication device is configured to wirelessly transmit the sensor data to an external device, since one of ordinary skill in the art would recognize that placing multiple pulse oximeters in a glove with a wireless communication for transmitting data was known in the art as taught by Delia. One of ordinary skill in the art would have expected that this modification could have been made with predictable results since Delia and Singh teach using of oxygen saturation data for monitoring the patient. The motivation would have been to have a convenient wearable sensor device capable to transmit wirelessly data in order to monitor remotely the patient reaction without interacting with the patient, as suggested by Delia.
Claims 32, 85 are rejected under 35 U.S.C. 103 as being unpatentable over Kalafut et al. (USPN 20100114064 A1; Pub.Date 05/06/2010; Fil.Date 11/03/2009) in view of Singh et al. (2008 J. Nucl. Med. Technol. 36:69–74; Pub.Date 2018) in view of Gujral et al. (USPN 20190328339 A1; Pub.Date 10/31/2019; Fil.Date 06/29/2018) in view of Mitra (USPN 20210196168 A1; Pub.Date 07/01/2021; Fil.Date 02/17/2017) in view of Aung et al. (USPN 20170340257 A1; Pub.Date 11/30/2017; Fil.Date 12/23/2015) in view of Tsunomori et al. (USPN 20170325771 A1; Pub.Date 11/16/2017; Fil.Date 04/26/2017) in view of Kamada (USPN 20110181286 A1; Pub.Date 07/08/2011; Fil.Date 10/02/2009) as applied to claim 27 and claim 57 and further in view of Delia (USPN 20160310085 A1; Pub.Date 10/27/2016; Fil.Date 04/21/2016) and Morley et al. (USPN 20120229270 A1; Pub.Date 09/13/2012; Fil.Date 03/11/2011).
Kalafut, Singh, Gujral, Mitra, Aung, Tsunomori and Kamada teach a system as set forth above. As discussed above, Kalafut, Singh, Gujral, Mitra, Aung and Tan teach a sensor device with different sensor elements therefore teaching a sensor device, wherein the at least one sensor is included in the sensor device.
Kalafut, Singh, Gujral, Mitra, Aung, Tsunomori and Kamada do not specifically teach, an elongated housing extending between a first end and a second end; and a pulse oximeter connected to the elongated housing via a wire, wherein the elongated housing is configured to surround at least one of a hand and a wrist of a patient, wherein the elongated housing includes a wireless communication device and at least one of a skin resistance sensor, an accelerometer, a temperature sensor, or any combination thereof, wherein the pulse oximeter and the at least one of the skin resistance sensor, the accelerometer, the temperature sensor, or any combination thereof are configured to determine the sensor data, and wherein the wireless communication device is configured to wirelessly transmit the sensor data to an external device as in claim 32 and claim 85.
However, Delia teaches within the same field of endeavor of medical examination device (Title and abstract) the design of a glove as elongated housing surrounding the hand and the wrist and including a pulse oximeter ([0039]) as part of a glove housing comprising hardware for sending signals/data from the sensor devices via wireless communication for remote access and analysis ([0004], [0039], Fig. 3 and 5 with element 12) wherein the sensors 1 are connected to the glove (wires as doted lines in Fig.5). Additionally Morley teaches within a similar glove the design of including a temperature sensor ([0011], [0023] and [0044], claim 9) for monitoring the temperature of the patient skin therefore Delia and Morley teaching an elongated housing extending between a first end and a second end; and a pulse oximeter connected to the elongated housing via a wire, wherein the elongated housing is configured to surround at least one of a hand and a wrist of a patient, wherein the elongated housing includes a wireless communication device and at least one of a skin resistance sensor, an accelerometer, a temperature sensor, or any combination thereof, wherein the pulse oximeter and the at least one of the skin resistance sensor, the accelerometer, the temperature sensor, or any combination thereof are configured to determine the sensor data, and wherein the wireless communication device is configured to wirelessly transmit the sensor data to an external device as claimed.
Therefore it would have been obvious for a person of ordinary skill in the art before the effective filling date of the invention to have modified the system of Kalafut as modified by Singh, Gujral, Mitra, Aung, Tsunomori and Kamada such that the system further comprises: an elongated housing extending between a first end and a second end; and a pulse oximeter connected to the elongated housing via a wire, wherein the elongated housing is configured to surround at least one of a hand and a wrist of a patient, wherein the elongated housing includes a wireless communication device and at least one of a skin resistance sensor, an accelerometer, a temperature sensor, or any combination thereof, wherein the pulse oximeter and the at least one of the skin resistance sensor, the accelerometer, the temperature sensor, or any combination thereof are configured to determine the sensor data, and wherein the wireless communication device is configured to wirelessly transmit the sensor data to an external device, since one of ordinary skill in the art would recognize that placing multiple pulse oximeters connected to the glove with wire and including a wireless communication for transmitting data was known in the art as taught by Delia and since such glove with temperature sensors were also known in the art as taught by Morley. One of ordinary skill in the art would have expected that this modification could have been made with predictable results since Morley, Delia and Singh teach using of oxygen saturation data for monitoring the patient. The motivation would have been to have a convenient wearable sensor device capable to transmit wirelessly data in order to monitor remotely the patient reaction without interacting with the patient, as suggested by Delia.
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 PATRICK M MEHL whose telephone number is (571)272-0572. The examiner can normally be reached Monday-Friday 9AM-6PM.
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/PATRICK M MEHL/Examiner, Art Unit 3798
/KEITH M RAYMOND/Supervisory Patent Examiner, Art Unit 3798