DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
This office action is in response to the remarks filed on 11/03/2025.
The amendment filed 11/03/2025 has been entered. Claims 1-15 remain pending in the application, claims 16-29 have been canceled, and claims 30-34 have been newly added and withdrawn.
The claim objection to claim 13 has been withdrawn in light of the claim amendments.
The 112(b) rejection has been withdrawn in light of claim amendments.
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 5-10, 13-15, and 30-34 are rejected under 35 U.S.C. 103 as being unpatentable over Nock et al. (US 20160081676 A1, hereinafter "Nock") in view of Alexiuk et al. (US 20120112747 A1, hereinafter "Alexiuk").
Regarding claim 1, Nock teaches a control module (control module (3300) [0198]) for use in an MRI guided biopsy procedure using an MRI coil (configured for use with biopsy device (1000) [0198]; MRI compatible biopsy system [0080]), the control module comprising:
(a) a body, including (control module 3300 has a body as shown in fig. 53 to which the display 3340 is attached to; fig. 53 [0198]):
(i) one or more ports configured to couple the control module to a biopsy device (Tube set interface (3330) [0199]; fig. 53), and
(ii) a display (a display screen (3340) [0198]; fig. 53) configured to output one or more biopsy device status indicators (Display screen (3340) is configured to provide a graphical user interface for the operator. By way of example only, display screen may display information relating to operation of biopsy device (1000) in accordance with the teachings of any of the various references cited herein); and
(iii) a housing (housing labeled in fig. 53 below) of which the display (a display screen (3340) [0198]; fig. 53) and the one or more ports (a tube set interface (3330) [0198]; Tube set interface (3330) is further in communication with a vacuum canister (3332), which is seated in control module (3300)) are affixed (display 3340 and ports 3330 are fixed to the housing, as shown in fig. 53, reproduced below);
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Fig. 53 of Nock reproduced above
Nock, however, is silent regarding (b) a gauss detection assembly at least partially positioned within the housing, the gauss detection assembly including one or more sensors integrated into the body of the control module, each sensor of the one or more sensors being configured to detect an electromagnetic field emitted from the MRI coil for the control module to thereby determine a gauss measurement.
Alexiuk is considered analogous to the instant application as “MRI Safety System” is disclosed (title).
Alexiuk teaches (b) a gauss detection assembly ([0188]-[0189], [0248] discloses Gauss detection) at least partially positioned within the housing (The arrangement described herein consists of a series of magnetic field sensors which are rigidly fixed to ferromagnetic objects in the OR [0060]; Equipment moved may include boom-mounted surgical lights and monitors, anaesthesia machines, patient monitors, carts and navigation systems [0006]; The arrangement described herein consists of a series of magnetic field sensors which are rigidly fixed to ferromagnetic objects in the OR. Many sensors can be deployed in the OR. Each sensor measures the magnetic field strength in 3 perpendicular dimensions. The system collects the measured field strength from each sensor several times a second [0060]), the gauss detection assembly including one or more sensors integrated into the body of the control module (The arrangement described herein consists of a series of magnetic field sensors which are rigidly fixed to ferromagnetic objects in the OR [0060]; Equipment moved may include boom-mounted surgical lights and monitors, anaesthesia machines, patient monitors, carts and navigation systems [0006]; Thus the control unit receives in real time a continual feed of the sensed fields in order to control and detect the relative positions of the components to the magnet and to carry out remedial action in the event that a dangerous condition is encountered [0119]; It is clearly advantageous to mount magnetic field sensors on equipment to create a secondary and automatic means to monitor safety hazards in this environment [0007]), each sensor of the one or more sensors being configured to detect an electromagnetic field emitted from the MRI coil for the control module to thereby determine a gauss measurement (The arrangement described herein consists of a series of magnetic field sensors which are rigidly fixed to ferromagnetic objects in the OR. Many sensors can be deployed in the OR. Each sensor measures the magnetic field strength in 3 perpendicular dimensions. The system collects the measured field strength from each sensor several times a second. When the field strength of any sensor exceeds a threshold T1 (say 5G), the system issues an alert. A second type of alert is issued when the field strength of any sensor exceeds a threshold T2 (say 50G). The alerts are configurable and may consist of an audible noise of a certain frequency, a flashing light in the room and/or the disabling of magnet movement [0060]; a variety of controlled devices, their current relationship (position) with respect to the MRI scanner, and a set of rules that enhance safety [0089]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Nock to modify the control module such that it includes a gauss detection assembly at least partially positioned within the housing, the gauss detection assembly including one or more sensors integrated into the body of the control module, each sensor of the one or more sensors being configured to detect an electromagnetic field emitted from the MRI coil, as taught by Alexiuk. Doing so would allow to enhance safety, as suggested by Alexiuk ([0088]-[0089], [0082]), further, Alexiuk discloses that [s]afety-related activities include moving MR-conditional and MR-unsafe, e.g. ferromagnetic, equipment to the exclusion zone bounded by the 5 gauss field line ([0006]).
Regarding claim 5, modified Nock teaches the control module of claim 1, as discussed above. Nock, however, is silent regarding a signal processing system, the signal processing system being in communication with each sensor of the one or more sensors, the signal processing system being configured to initiate one or more operational controls when the electromagnetic field detected by the one or more sensors exceeds a predetermined threshold.
Alexiuk, however, teaches a signal processing system, the signal processing system being in communication with each sensor of the one or more sensors, the signal processing system being configured to initiate one or more operational controls when the electromagnetic field detected by the one or more sensors exceeds a predetermined threshold (The sensor network consists of a PC interface, a base station and multiple sensor nodes. A sensor evaluation board is used to compare measurement performance of giant magneto-resistive (GMR) sensors to Hall effect sensors. Hall effect sensors are selected based on lower current draw (sleep and active modes) and larger measurement range. This design is implemented on a custom printed circuit board (FIG. 2). Main sensor components include: power supply, Hall effect sensors, anti-aliasing filters, microcontroller (PIC18F, Microchip) and RF module (MRF24J40MA, Microchip). In monitoring mode, the microcontroller queries the Hall effect sensors sequentially. The magnetic field magnitude is compared to software-set thresholds (5G, 50G) that represent alarm conditions [0093]; Use of the magnitude of the measured magnetic fields to compare against a threshold for possible alarm [0161]; Use of one or more of the (x,y,z) measured magnetic field components in order to determine or estimate the relative position between objects or the absolute position of a single object [0162]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Nock to include a signal processing system, the signal processing system being in communication with each sensor of the one or more sensors, the signal processing system being configured to initiate one or more operational controls when the electromagnetic field detected by the one or more sensors exceeds a predetermined threshold, as taught by Alexiuk. Doing so would allow to enhance safety, as suggested by Alexiuk ([0088]-[0089], [0082]), further, Alexiuk discloses that [s]afety-related activities include moving MR-conditional and MR-unsafe, e.g. ferromagnetic, equipment to the exclusion zone bounded by the 5 gauss field line ([0006]).
Regarding claim 6, modified Nock teaches the control module of claim 1, as discussed above. Nock, however, is silent regarding a signal processing system, the one or more sensors including a plurality of sensors, the signal processing system being in communication with each sensor of the plurality of sensors, the signal processing system being configured to: receive a detected electromagnetic field signal from each sensor of the plurality of sensors, and compute a position of the control module relative to the MRI coil.
Alexiuk, however, teaches a signal processing system, the one or more sensors including a plurality of sensors (mount magnetic field sensors on equipment [0007]), the signal processing system being in communication with each sensor of the plurality of sensors (the control unit receives in real time a continual feed of the sensed fields in order to control and detect the relative positions of the component [0019], the signal processing system being configured to:
receive a detected electromagnetic field signal from each sensor of the plurality of sensors (The sensor network consists of a PC interface, a base station and multiple sensor nodes. A sensor evaluation board is used to compare measurement performance of giant magneto-resistive (GMR) sensors to Hall effect sensors. Hall effect sensors are selected based on lower current draw (sleep and active modes) and larger measurement range. This design is implemented on a custom printed circuit board (FIG. 2). Main sensor components include: power supply, Hall effect sensors, anti-aliasing filters, microcontroller (PIC18F, Microchip) and RF module (MRF24J40MA, Microchip). In monitoring mode, the microcontroller queries the Hall effect sensors sequentially. The magnetic field magnitude is compared to software-set thresholds (5G, 50G) that represent alarm conditions [0093], and
compute a position of the control module relative to the MRI coil (Use of the magnitude of the measured magnetic fields to compare against a threshold for possible alarm [0161]; Use of one or more of the (x,y,z) measured magnetic field components in order to determine or estimate the relative position between objects or the absolute position of a single object [0162]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Nock to include a signal processing system, the one or more sensors including a plurality of sensors, the signal processing system being in communication with each sensor of the plurality of sensors, the signal processing system being configured to: receive a detected electromagnetic field signal from each sensor of the plurality of sensors, and compute a position of the control module relative to the MRI coil, as taught by Alexiuk. Doing so would allow to enhance safety, as suggested by Alexiuk ([0088]-[0089], [0082]), further, Alexiuk discloses that [s]afety-related activities include moving MR-conditional and MR-unsafe, e.g. ferromagnetic, equipment to the exclusion zone bounded by the 5 gauss field line ([0006]).
Regarding claim 7, modified Nock teaches the control module of claim 1, as discussed above. Nock, however is silent regarding a signal processing system, the one or more sensors including a plurality of sensors, the signal processing system being in communication with each sensor of the plurality of sensors, the signal processing system being configured to: receive a detected electromagnetic field signal from each sensor of the plurality of sensors, compute an orientation of the control module relative to the MRI coil, and compare one or more of the detected electromagnetic field signals to a predetermined threshold value corresponding to the computed orientation of the control module relative to the MRI coil.
Alexiuk, however, teaches:
a signal processing system, the one or more sensors including a plurality of sensors (mount magnetic field sensors on equipment [0007]), the signal processing system being in communication with each sensor of the plurality of sensors (the control unit receives in real time a continual feed of the sensed fields in order to control and detect the relative positions of the component [0019], the signal processing system being configured to:
receive a detected electromagnetic field signal from each sensor of the plurality of sensors (Use of the magnitude of the measured magnetic fields to compare against a threshold for possible alarm [0161]; Use of one or more of the (x,y,z) measured magnetic field components in order to determine or estimate the relative position between objects or the absolute position of a single object [0162]),
compute the orientation of the control module relative to the MRI coil (Use of one or more of the (x,y,z) measured magnetic field components in order to determine or estimate the relative position between objects or the absolute position of a single object [0162]), and
compare one or more of the detected electromagnetic field signals to a predetermined threshold value corresponding to the computed orientation of the control module relative to the MRI coil (Thus the control unit receives in real time a continual feed of the sensed fields in order to control and detect the relative positions of the components to the magnet and to carry out remedial action in the event that a dangerous condition is encountered [0119]; Use of the magnitude of the measured magnetic fields to compare against a threshold for possible alarm [0161])
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Nock to include a signal processing system, the one or more sensors including a plurality of sensors, the signal processing system being in communication with each sensor of the plurality of sensors, the signal processing system being configured to: receive a detected electromagnetic field signal from each sensor of the plurality of sensors, compute an orientation of the control module relative to the MRI coil, and compare one or more of the detected electromagnetic field signals to a predetermined threshold value corresponding to the computed orientation of the control module relative to the MRI coil, as taught by Alexiuk. Doing so would allow to enhance safety, as suggested by Alexiuk ([0088]-[0089], [0082]), further, Alexiuk discloses that [s]afety-related activities include moving MR-conditional and MR-unsafe, e.g. ferromagnetic, equipment to the exclusion zone bounded by the 5 gauss field line ([0006]).
Regarding claim 8, modified Nock teaches control module of claim 1, as discussed above. Nock, however, is silent regarding a signal processing system, the one or more sensors including a plurality of sensors, the signal processing system being in communication with each sensor of the plurality of sensors, the signal processing system being configured to: receive a detected electromagnetic field signal from each sensor of the plurality of sensors, compute an orientation of the control module relative to the MRI coil, compare one or more of the detected electromagnetic field signals to a predetermined threshold value corresponding to the computed orientation of the control module relative to the MRI coil, and initiate one or more operational controls when the predetermined threshold value is exceeded by one or more of the detected electromagnetic field signals.
Alexiuk, however, teaches
a signal processing system, the one or more sensors including a plurality of sensors (mount magnetic field sensors on equipment [0007]), the signal processing system being in communication with each sensor of the plurality of sensors (the control unit receives in real time a continual feed of the sensed fields in order to control and detect the relative positions of the component [0019], the signal processing system being configured to:
receive a detected electromagnetic field signal from each sensor of the plurality of sensors (Use of the magnitude of the measured magnetic fields to compare against a threshold for possible alarm [0161]; Use of one or more of the (x,y,z) measured magnetic field components in order to determine or estimate the relative position between objects or the absolute position of a single object [0162]),
compute an orientation of the control module relative to the MRI coil (Use of one or more of the (x,y,z) measured magnetic field components in order to determine or estimate the relative position between objects or the absolute position of a single object [0162]), and
compare one or more of the detected electromagnetic field signals to a predetermined threshold value corresponding to the computed orientation of the control module relative to the MRI coil (Thus the control unit receives in real time a continual feed of the sensed fields in order to control and detect the relative positions of the components to the magnet and to carry out remedial action in the event that a dangerous condition is encountered [0119]; Use of the magnitude of the measured magnetic fields to compare against a threshold for possible alarm [0161]),
initiate one or more operational controls when the predetermined threshold value is exceeded by one or more of the detected electromagnetic field signals (Use of the magnitude of the measured magnetic fields to compare against a threshold for possible alarm [0161]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Nock to include a signal processing system, the one or more sensors including a plurality of sensors, the signal processing system being in communication with each sensor of the plurality of sensors, the signal processing system being configured to: receive a detected electromagnetic field signal from each sensor of the plurality of sensors, compute an orientation of the control module relative to the MRI coil, compare one or more of the detected electromagnetic field signals to a predetermined threshold value corresponding to the computed orientation of the control module relative to the MRI coil, and initiate one or more operational controls when the predetermined threshold value is exceeded by one or more of the detected electromagnetic field signals, as taught by Alexiuk. Doing so would allow to enhance safety, as suggested by Alexiuk ([0088]-[0089], [0082]), further, Alexiuk discloses that [s]afety-related activities include moving MR-conditional and MR-unsafe, e.g. ferromagnetic, equipment to the exclusion zone bounded by the 5 gauss field line ([0006]).
Regarding claim 9, modified Nock teaches control module of claim 1, as discussed above. Nock, however, is silent regarding a signal processing system and an indicator, the signal processing system being in communication with each sensor of the one or more sensors, the signal processing system being further in communication with the indicator, the signal processing system being configured to initiate one or more operational controls via the indicator when the electromagnetic field detected by the one or more sensors exceeds a predetermined threshold.
Alexiuk, however, teaches a signal processing system and an indicator, the signal processing system being in communication with each sensor of the one or more sensors, the signal processing system being further in communication with the indicator (The system collects the measured field strength from each sensor several times a second. When the field strength of any sensor exceeds a threshold T1 (say 5G), the system issues an alert….The alerts are configurable and may consist of an audible noise of a certain frequency, a flashing light in the room and/or the disabling of magnet movement [0060]), the signal processing system being configured to initiate one or more operational controls via the indicator when the electromagnetic field detected by the one or more sensors exceeds a predetermined threshold (Thus the control unit receives in real time a continual feed of the sensed fields in order to control and detect the relative positions of the components to the magnet and to carry out remedial action in the event that a dangerous condition is encountered [0119]; Use of the magnitude of the measured magnetic fields to compare against a threshold for possible alarm [0161]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Nock to include a signal processing system and an indicator, the signal processing system being in communication with each sensor of the one or more sensors, the signal processing system being further in communication with the indicator, the signal processing system being configured to initiate one or more operational controls via the indicator when the electromagnetic field detected by the one or more sensors exceeds a predetermined threshold, as taught by Alexiuk. Doing so would allow to enhance safety, as suggested by Alexiuk ([0088]-[0089], [0082]), further, Alexiuk discloses that [s]afety-related activities include moving MR-conditional and MR-unsafe, e.g. ferromagnetic, equipment to the exclusion zone bounded by the 5 gauss field line ([0006]).
Regarding claim 10, modified Nock teaches control module of claim 9, as discussed above. Nock further teaches a first illuminator, a second illuminator, and a third illuminator (a plurality of light emitters (3354) [0201]; three light emitters depicted in fig. 54 on assembly 3350) the signal processing system being configured to illuminate each of the first illuminator, second illuminator, and third illuminator (assembly (3350) further includes a biopsy device connector (3356). Biopsy device connector (3356) may be used as an alternative port by which biopsy device (1000) may connect to control module (3300) [0202]). Nock, however, is silent regarding, [the signal processing system being configured to illuminate each of the first illuminator, second illuminator, and third illuminator] based on the electromagnetic field detected by the one or more sensors.
Alexiuk, however, teaches signal processing system being configured to illuminate each of the … illuminator(s), based on the electromagnetic field detected by the one or more sensors (The system collects the measured field strength from each sensor several times a second. When the field strength of any sensor exceeds a threshold T1 (say 5G), the system issues an alert. A second type of alert is issued when the field strength of any sensor exceeds a threshold T2 (say 50G). The alerts are configurable and may consist of an audible noise of a certain frequency, a flashing light in the room and/or the disabling of magnet movement [0060]; multiple OR alarms shown in fig. 1).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Nock to modify the illuminators such that it is illuminated based on the electromagnetic field detected by the one or more sensors, as taught by Alexiuk. Doing so would allow to enhance safety, as suggested by Alexiuk ([0088]-[0089], [0082]), further, Alexiuk discloses that [s]afety-related activities include moving MR-conditional and MR-unsafe, e.g. ferromagnetic, equipment to the exclusion zone bounded by the 5 gauss field line ([0006]).
Regarding claim 13, modified Nock teaches the control module of claim 9. Nock, however is silent regarding, the indicator including a wheel lock associated with one or more wheels attached to the body, the signal processing system being further configured to transition the wheel lock from an open position to a closed position when the electromagnetic field detected by the one or more sensors exceeds a predetermined threshold.
Alexiuk, however, teaches the signal processing system being further configured to transition the wheel lock from an open position to a closed position when the electromagnetic field detected by the one or more sensors exceeds a predetermined threshold (the system is primarily designed for use with the IMRIS movable magnet arrangement, the same system can be used with a fixed magnet and moving objects or components. The above system is still relevant to increasing safety in the room in that the distributed sensors provide information of the magnetic field for the moving objects. …. When the equipment is moved toward a potentially dangerous area of higher magnetic field, a safety mechanism locks the wheels of the equipment or triggers alarm [0085]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Nock to include the signal processing system being further configured to transition the wheel lock from an open position to a closed position when the electromagnetic field detected by the one or more sensors exceeds a predetermined threshold, as taught by Alexiuk. Doing so would allow to enhance safety, as suggested by Alexiuk ([0088]-[0089], [0082]), further, Alexiuk discloses that [s]afety-related activities include moving MR-conditional and MR-unsafe, e.g. ferromagnetic, equipment to the exclusion zone bounded by the 5 gauss field line ([0006]).
Regarding claim 14, modified Nock teaches the control module of claim 9, as discussed above. Nock, further teaches the indicator being remotely positioned relative to the body (Light emitters (3354) may be configured to indicate basic information regarding biopsy device (1000) to a user [0201]; indicators 3354 are positioned relative to the body of the control module 3330 as shown in figs. 53 and 54).
Regarding claim 15, modified Nock teaches the control module of claim 1, as discussed above. Nock, however is silent regarding each sensor of the one or more sensors including a hall effect sensor.
Alexiuk, however, teaches each sensor of the one or more sensors including a hall effect sensor (Three single-axis Hall Effect sensors may be used in conjunction to measure a magnetic field in three directions [0169]; Main sensor components include: power supply, Hall effect sensors [0093]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Nock to include each sensor of the one or more sensors including a hall effect sensor, as suggested by Alexiuk ([0088]-[0089], [0082]), further, Alexiuk discloses that [s]afety-related activities include moving MR-conditional and MR-unsafe, e.g. ferromagnetic, equipment to the exclusion zone bounded by the 5 gauss field line ([0006]).
Regarding claim 30, Nock teaches a control module for use in an MRI guided biopsy procedure using an MRI coil (configured for use with biopsy device (1000) [0198]; MRI compatible biopsy system [0080]), the control module comprising:
(a) a body(control module 3300 has a body as shown in fig. 53 to which the display 3340 is attached to; fig. 53 [0198]), including:
(i) one or more ports configured to couple the control module to a biopsy device (Tube set interface (3330) [0199]; fig. 53), and
(ii) a display (a display screen (3340) [0198]; fig. 53) configured to output one or more biopsy device status indicators (Display screen (3340) is configured to provide a graphical user interface for the operator. By way of example only, display screen may display information relating to operation of biopsy device (1000) in accordance with the teachings of any of the various references cited herein); and
Nock, however, does not teach:
(b) a gauss detection assembly, the gauss detection assembly including one or more sensors integrated into the body of the control module, each sensor of the one or more sensors being configured to detect a field emitted from the MRI coil,
wherein the display is further configured to indicate a position of the control module relative to the MRI coil based on the detected field emitted from the MRI coil.
Alexiuk is considered analogous to the instant application as “MRI Safety System” is disclosed (title).
(b) a gauss detection assembly ([0188]-[0189], [0248] discloses Gauss detection, the gauss detection assembly including one or more sensors integrated into the body of the control module (The arrangement described herein consists of a series of magnetic field sensors which are rigidly fixed to ferromagnetic objects in the OR [0060]; Equipment moved may include boom-mounted surgical lights and monitors, anaesthesia machines, patient monitors, carts and navigation systems [0006]; Thus the control unit receives in real time a continual feed of the sensed fields in order to control and detect the relative positions of the components to the magnet and to carry out remedial action in the event that a dangerous condition is encountered [0119]; It is clearly advantageous to mount magnetic field sensors on equipment to create a secondary and automatic means to monitor safety hazards in this environment [0007]), each sensor of the one or more sensors being configured to detect a field emitted from the MRI coil (The arrangement described herein consists of a series of magnetic field sensors which are rigidly fixed to ferromagnetic objects in the OR. Many sensors can be deployed in the OR. Each sensor measures the magnetic field strength in 3 perpendicular dimensions. The system collects the measured field strength from each sensor several times a second. When the field strength of any sensor exceeds a threshold T1 (say 5G), the system issues an alert. A second type of alert is issued when the field strength of any sensor exceeds a threshold T2 (say 50G). The alerts are configurable and may consist of an audible noise of a certain frequency, a flashing light in the room and/or the disabling of magnet movement [0060]; a variety of controlled devices, their current relationship (position) with respect to the MRI scanner, and a set of rules that enhance safety [0089]).,
wherein the display is further configured to indicate a position of the control module relative to the MRI coil based on the detected field emitted from the MRI coil (Integrate the system with the magnet mover, or an audio/visual display, or a real-time asset tracking system [0068]; On receipt of an alarm condition, the location of the sensor is displayed based on the configuration look-up table. Further room control actions are also possible).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Nock to modify the control module such that it includes a gauss detection assembly, the gauss detection assembly including one or more sensors integrated into the body of the control module, each sensor of the one or more sensors being configured to detect a field emitted from the MRI coil, and wherein the display is further configured to indicate a position of the control module relative to the MRI coil based on the detected field emitted from the MRI coil, as taught by Alexiuk. Doing so would allow to enhance safety, as suggested by Alexiuk ([0088]-[0089], [0082]), further, Alexiuk discloses that [s]afety-related activities include moving MR-conditional and MR-unsafe, e.g. ferromagnetic, equipment to the exclusion zone bounded by the 5 gauss field line ([0006]).
Regarding claim 31, modified Nock teaches control module of claim 30, as discussed above. Nock, however, does not teach wherein the control module is configured to trigger an alert in the biopsy device upon a proximation of the control module relative to the MRI coil.
Nock, however, teaches wherein the control module is configured to trigger an alert in the biopsy device upon a proximation of the control module relative to the MRI coil (The arrangement described herein consists of a series of magnetic field sensors which are rigidly fixed to ferromagnetic objects in the OR [0060]; Equipment moved may include boom-mounted surgical lights and monitors, anaesthesia machines, patient monitors, carts and navigation systems [0006]; Thus the control unit receives in real time a continual feed of the sensed fields in order to control and detect the relative positions of the components to the magnet and to carry out remedial action in the event that a dangerous condition is encountered [0119]; It is clearly advantageous to mount magnetic field sensors on equipment to create a secondary and automatic means to monitor safety hazards in this environment [0007]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Nock to modify the control module such that it includes wherein the control module is configured to trigger an alert in the biopsy device upon a proximation of the control module relative to the MRI coil, as taught by Alexiuk. Doing so would allow to enhance safety, as suggested by Alexiuk ([0088]-[0089], [0082]), further, Alexiuk discloses that [s]afety-related activities include moving MR-conditional and MR-unsafe, e.g. ferromagnetic, equipment to the exclusion zone bounded by the 5 gauss field line ([0006]).
Regarding claim 32, modified Nock teaches the control module of claim 30, as discussed above. Nock, however, does not teach wherein the gauss detection assembly is configured to control the biopsy device to thereby prevent a collection of a tissue sample.
Alexiuk, however, teaches wherein the gauss detection assembly is configured to control the biopsy device to thereby prevent a collection of a tissue sample (wherein the gauss detection assembly is configured to control the biopsy device to thereby prevent a collection of a tissue sample. [0082] ; [0113]-[0016] discloses that all components within the room are tracked, including surgical instruments;; [0188]-[0190] discloses that when an alarm is triggered, operations including stopping the MRI magnet is stopped).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Nock to include wherein the gauss detection assembly is configured to control the biopsy device to thereby prevent a collection of a tissue sample, as suggested by Alexiuk ([0088]-[0089], [0082]), further, Alexiuk discloses that [s]afety-related activities include moving MR-conditional and MR-unsafe, e.g. ferromagnetic, equipment to the exclusion zone bounded by the 5 gauss field line ([0006]).
Regarding claim 33, Nock teaches a control module for use in an MRI guided biopsy procedure using an MRI coil, the control module comprising:
(a) a body (control module 3300 has a body as shown in fig. 53 to which the display 3340 is attached to; fig. 53 [0198]), including:
(i) one or more ports configured to couple the control module to a biopsy device (Tube set interface (3330) [0199]; fig. 53),
(ii) a display (a display screen (3340) [0198]; fig. 53) configured to output one or more biopsy device status indicators (Display screen (3340) is configured to provide a graphical user interface for the operator. By way of example only, display screen may display information relating to operation of biopsy device (1000) in accordance with the teachings of any of the various references cited herein);, and
(iii) an illumination device (Light emitters (3354) may be configured to indicate basic information regarding biopsy device (1000) to a user. For instance, in some examples light emitters (3354) may be color coded to indicate an error condition (red), a warning condition (yellow), and a ready condition (green) [0201]; and
Nock, however, does not teach:
(b) a gauss detection assembly, the gauss detection assembly including one or more sensors integrated into the body of the control module, each sensor of the one or more sensors being configured to detect an electromagnetic field emitted from the MRI coil, the gauss detection assembly being in electrical communication with the display and with the illumination device to thereby be configured to indicate the detected electromagnetic field on each of the display and the illumination device.
Alexiuk is considered analogous to the instant application as “MRI Safety System” is disclosed (title). Alexiuk teaches:
(b) a gauss detection assembly ([0188]-[0189], [0248] discloses Gauss detection), the gauss detection assembly including one or more sensors integrated into the body of the control module (The arrangement described herein consists of a series of magnetic field sensors which are rigidly fixed to ferromagnetic objects in the OR [0060]; Equipment moved may include boom-mounted surgical lights and monitors, anaesthesia machines, patient monitors, carts and navigation systems [0006]; Thus the control unit receives in real time a continual feed of the sensed fields in order to control and detect the relative positions of the components to the magnet and to carry out remedial action in the event that a dangerous condition is encountered [0119]; It is clearly advantageous to mount magnetic field sensors on equipment to create a secondary and automatic means to monitor safety hazards in this environment [0007]), each sensor of the one or more sensors being configured to detect an electromagnetic field emitted from the MRI coil (The arrangement described herein consists of a series of magnetic field sensors which are rigidly fixed to ferromagnetic objects in the OR. Many sensors can be deployed in the OR. Each sensor measures the magnetic field strength in 3 perpendicular dimensions. The system collects the measured field strength from each sensor several times a second. When the field strength of any sensor exceeds a threshold T1 (say 5G), the system issues an alert. A second type of alert is issued when the field strength of any sensor exceeds a threshold T2 (say 50G). The alerts are configurable and may consist of an audible noise of a certain frequency, a flashing light in the room and/or the disabling of magnet movement [0060]; a variety of controlled devices, their current relationship (position) with respect to the MRI scanner, and a set of rules that enhance safety [0089]), the gauss detection assembly being in electrical communication with the display and with the illumination device (Certain status messages can be shown on a LCD mounted directly over top of the Base Station [0215]) to thereby be configured to indicate the detected electromagnetic field on each of the display and the illumination device (The arrangement described herein consists of a series of magnetic field sensors which are rigidly fixed to ferromagnetic objects in the OR. Many sensors can be deployed in the OR. Each sensor measures the magnetic field strength in 3 perpendicular dimensions. The system collects the measured field strength from each sensor several times a second. When the field strength of any sensor exceeds a threshold T1 (say 5G), the system issues an alert. A second type of alert is issued when the field strength of any sensor exceeds a threshold T2 (say 50G). The alerts are configurable and may consist of an audible noise of a certain frequency, a flashing light in the room and/or the disabling of magnet movement [0060]; a variety of controlled devices, their current relationship (position) with respect to the MRI scanner, and a set of rules that enhance safety [0089]).
Regarding claim 34, modified Nock teaches the control module of claim 33, as discussed above. Nock, however, does not teach wherein the illumination device is positioned above the display.
Alexiuk, however teaches wherein the illumination device is positioned above the display.
(Sensors register with the base station and go into sleep mode. The base station is connected to a central room control system which includes displays and audio alarms [0095]; Certain status messages can be shown on a LCD mounted directly over top of the Base Station [0215];
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Nock to include wherein the illumination device is positioned above the display as suggested by Alexiuk ([0088]-[0089], [0082]), further, Alexiuk discloses that [s]afety-related activities include moving MR-conditional and MR-unsafe, e.g. ferromagnetic, equipment to the exclusion zone bounded by the 5 gauss field line ([0006]).
Claims 2-4 are rejected under 35 U.S.C. 103 as being unpatentable over Nock et al. (US 20160081676 A1, hereinafter "Nock") in view of Alexiuk et al. (US 20120112747 A1, hereinafter "Alexiuk") and Kopp (US 20030171669 A1).
Regarding claim 2, combined Nock teaches the control module of claim 1, as discussed above. The combined invention, however, is silent regarding a detector array, each sensor of the one or more sensors being arranged on the detector array.
Kopp is considered analogous to the instant application as “MRI protector” is disclosed (title).
Kopp teaches a detector array, each sensor of the one or more sensors being arranged on the detector array (deployment of the array of Hall effect sensors to scan the residual magnetic field that exists in the vicinity of an MRI apparatus and recognize the characteristic signature of ferrous intrusion [0015]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Nock to include a detector array, each sensor of the one or more sensors being arranged on the detector array, as taught by Kopp. Doing so would prevent the introduction of ferrous objects into the magnetic field of an MRI apparatus where their uncontrolled movement may become a danger to personnel and the MRI apparatus, as suggested by Kopp ([0013]).
Regarding claim 3, modified Nock teaches control module of claim 2, as discussed above. Nock, however is silent regarding the detector array including a single sensor.
Kopp, however, teaches the detector array including a single sensor (deployment of the array of Hall effect sensors to scan the residual magnetic field that exists in the vicinity of an MRI apparatus and recognize the characteristic signature of ferrous intrusion [0015]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Nock to include the detector array including a single sensor, as taught by Kopp. Doing so would prevent the introduction of ferrous objects into the magnetic field of an MRI apparatus where their uncontrolled movement may become a danger to personnel and the MRI apparatus, as suggested by Kopp ([0013]).
Regarding claim 4, modified Nock teaches control module of claim 2, as discussed above. Nock, however, is silent regarding the detector array including a plurality of sensors, each sensor being positioned along an axis aligned with a geometric feature of the body, each sensor being configured to detect the electromagnetic field emitted from the MRI coil in a single dimension or multiple dimensions.
Alexiuk, however teaches the detector array including a plurality of sensors, each sensor being positioned along an axis aligned with a geometric feature of the body (Preferably each sensor measures the magnetic field strength in three perpendicular dimensions [0027]), each sensor being configured to detect the electromagnetic field emitted from the MRI coil in a single dimension or multiple dimensions (The arrangement described herein consists of a series of magnetic field sensors which are rigidly fixed to ferromagnetic objects in the OR. Many sensors can be deployed in the OR. Each sensor measures the magnetic field strength in 3 perpendicular dimensions. The system collects the measured field strength from each sensor several times a second [0060]; Thus the control unit receives in real time a continual feed of the sensed fields in order to control and detect the relative positions of the components to the magnet and to carry out remedial action in the event that a dangerous condition is encountered [0119]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Nock to modify the control module such that it includes the detector array including a plurality of sensors, each sensor being positioned along an axis aligned with a geometric feature of the body, each sensor being configured to detect the electromagnetic field emitted from the MRI coil in a single dimension or multiple dimensions, as suggested by Alexiuk. Doing so would allow to enhance safety, as suggested by Alexiuk ([0088]-[0089], [0082])
Claims 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Nock et al. (US 20160081676 A1, hereinafter "Nock") in view of Alexiuk et al. (US 20120112747 A1, hereinafter "Alexiuk") and Susi et al (US 20240410913 A1, hereinafter “Susi”).
Regarding claim 11, modified Nock teaches the control module of claims 9, as discussed above. Nock, however, is silent regarding the signal processing system being configured to the light of the predetermined color based on the electromagnetic field detected by the one or more sensors.
Susi is considered analogous to the instant application as “FERROMAGNETIC DETECTOR AND THREAT ANALYSIS” is disclosed (title).
Susi teaches regarding the signal processing system (outputting the first signal to a processing means (e.g., one or more processors, such as microprocessors) [0028]) being configured to the light of the predetermined color based on the electromagnetic field detected by the one or more sensors (The first sensor array is configured to generate one or more first signals (e.g., a first signal) in response to detecting a magnetic field indicating the presence of a ferromagnetic object in proximity to the first sensor array and to output the first signal [0005]; The alert may include activating one or more LEDs or light sources. The alert may be one or more colors depending on the level of severity of the threat if the LEDs or other light sources are capable of displaying different colors. In some embodiments, the threat may be output to a display [0110]; a plurality of light-emitting diodes (“LEDs”) configured to secure to the passageway and emit light of one or more colors (e.g., one, two, three, or more colors). Each of the one or more colors may indicate a unique status or condition of an alert, and the statuses or conditions of alert may include, for example, (1) no threat, (2) potential threat, and/or (3) actual threat. In one example, no threat may correspond to a green color, potential threat may correspond to a yellow color, and actual threat may correspond to a red color [0013]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Nock to include the signal processing system being configured to the light of the predetermined color based on the electromagnetic field detected by the one or more sensors, as taught by Susi. Doing so would provide a more accurate and more robust system that is less prone to false alarms that would likely lead to disabling or ignoring of the alarm system, which would, in turn, reduce safety instead of enhancing safety, as suggested by Susi ([0065]).
Regarding claim 12, modified Nock teaches the control module of claim 9, as discussed above. Nock, however, is silent regarding the indicator including a first indicator and a second indicator, the first indicator being configured to emit a green light and to emit a yellow light, the second indicator including a buzzer, the signal processing system being configured to emit the green light or the yellow light based on the electromagnetic field detected by the one or more sensors, the signal processing system being further configured to initiate the buzzer when the electromagnetic field detected by the one or more sensors exceeds a predetermined threshold.
Susi, however, teaches the indicator including a first indicator and a second indicator (Multiple sets of LEDs 9 (e.g., three-color LEDs) [0071]) , the first indicator being configured to emit a green light and to emit a yellow light (green can indicate the passage is clear of threats, yellow can indicate that the sensors 8 detect a possible magnetic threat in range, and red can indicate that the threat's speed and direction along with magnetic signal threshold [0071]), the second indicator including a buzzer (The alert may also include audible alerts in addition to visible alerts [0014]), the signal processing system being configured to emit the green light or the yellow light based on the electromagnetic field detected by the one or more sensors (green can indicate the passage is clear of threats, yellow can indicate that the sensors 8 detect a possible magnetic threat in range, and red can indicate that the threat's speed and direction along with magnetic signal threshold [0071]),, the signal processing system being further configured to initiate the buzzer when the electromagnetic field detected by the one or more sensors exceeds a predetermined threshold (The alert may also include audible alerts in addition to visible alerts [0014])
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Nock to include the indicator including a first indicator and a second indicator, the first indicator being configured to emit a green light and to emit a yellow light, the second indicator including a buzzer, the signal processing system being configured to emit the green light or the yellow light based on the electromagnetic field detected by the one or more sensors, the signal processing system being further configured to initiate the buzzer when the electromagnetic field detected by the one or more sensors exceeds a predetermined threshold, as taught by Susi. Doing so would provide a more accurate and more robust system that is less prone to false alarms that would likely lead to disabling or ignoring of the alarm system, which would, in turn, reduce safety instead of enhancing safety, as suggested by Susi ([0065]).
Response to Arguments
Applicant's arguments filed 11/03/2025 have been fully considered but they are not persuasive.
Regarding the 35 USC § 103 rejection of claim 1, applicant argues on pages 7-8, that the prior art does not teach the newly added limitation regarding “a gauss detection assembly at least partially positioned within the housing”. In response the examiner asserts that Alexiuk discloses that a gauss detection assembly ([0188]-[0189], [0248] discloses Gauss detection) at least partially positioned within the housing (The arrangement described herein consists of a series of magnetic field sensors which are rigidly fixed to ferromagnetic objects in the OR [0060]; Equipment moved may include boom-mounted surgical lights and monitors, anaesthesia machines, patient monitors, carts and navigation systems [0006]). In other words, the sensors are fixed/within the housing/body of the control module.
Accordingly, the argument is not persuasive.
Regarding the 35 USC § 103 rejection of the remaining dependent claims, applicant argument’s on page 8 are premised upon the assertion that the claims are allowable as it is not taught or suggested in the prior art. The examiner respectfully disagrees for the reasons stated above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Molyneaux (US20070132581A1)
[0006] Embodiments can improve magnetic resonance imaging (MRI) safety and increase the safety of MRI facilities. Embodiments of the subject system can detect a given magnetic field strength around a magnetic resonance imaging (MRI) machine and alert users to the field's presence.
[0020] As the subject badge may be worn on the body, the temperature of the device can be considered to compensate for thermoelectric, or other temperature-related effects. In an embodiment, the badge can be constructed of non-ferromagnetic materials to prevent it from being projected toward the magnet. An embodiment of the magnetic sensor badge can use three linear Hall affect sensors to detect magnetic fields in three perpendicular directions. The badge can sound an alarm and/or light up an LED or other visual display, or trigger other alerting signals, in the presence of a certain magnitude magnetic field. In various embodiments, the magnitude of the magnetic field that triggers the alert is a 5 Gauss field, a 10 Gauss field, a 20 Gauss field, and a 50 Gauss field, respectively. In another embodiment, a certain magnetic field, for example, a 100 Gauss field, can trigger a buzzer to sound where the buzzer has a different sound, volume, or other characteristic. Other techniques, such as a mechanical vibration, can be used to alert the wearer of the badge and/or others.
[0038] The magnetic field detection badge shown in FIG. 2 has three major functional subsystems: field detection, status generation, and power. These three groups are managed with a small, low power microcontroller.
THIS ACTION IS MADE FINAL. 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.
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/N.B./ Examiner, Art Unit 3798
/PASCAL M BUI PHO/ Supervisory Patent Examiner, Art Unit 3798