DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being considered under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 and 11 regarding the amended limitations of “an input element on the housing; wherein the control unit is configured to reset the displacement value when the input element is actuated irrespective of the signals and to continue maintaining the displacement value based on the signals received after the input element is actuated” have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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.
Claim(s) 1-4, 8-10 and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Buesseler (US 2018/0228395 A1)(previously of record) in view of Reisin (US 2021/0007760 A1)(previously of record), further in view of Dalal (US 2014/0171792 A1)(previously of record), further in view of Rand (US 4979898 A).
Regarding claim 1, Buesseler discloses:
An introducer sheath (introducer 66, see Fig. 10B), comprising:
a hub (handle 24, see Fig. 1; the handle 24 is seen to be used with all catheter and introducer sheath embodiments unless otherwise stated) forming a proximal opening to a lumen (as the introducer sheath 66 is extends from the handle 24 and comprises an internal lumen (shown in Fig. 10B), the handle is seen to connect to a proximal end of the lumen of the introducer sheath 66);
a shaft extending distally from the hub (main body of the introducer sheath 66, see Fig. 10B which is seen to extend distally from the handle 24; this interpretation is consistent with the disclosure of the claimed invention in which the shaft (211) is the elongate body of the introducer sheath (210) as shown in Fig. 2 and recited in Para. [0024] of the Specification), the lumen extending through the shaft to form a distal opening (see Fig. 10B); and
a displacement sensor (sensor 70/70A, see Para. [0045]-[0046] and [0050] mentioning wherein sensor 70 can determine the location of the distal end of an internal catheter 56 relative to the distal end of the introducer 66 based on the relative distance(s) between the sensor 70 and longitudinal sensor members 58 positioned along the length of the catheter), comprising:
a sensor unit (position detection module, see Para. [0050]-[0051]) positioned to detect displacement of a catheter (catheter 56, see Fig. 2A and 10B) within the lumen (see Fig. 2A and 10B, see also Para. [0050]-[0051]) and to output signals representing the detected displacement (see Para. [0050]-[0051]); and
a control unit (ECU 42, see Fig. 1, see Para. [0050]-[0051]) that is configured to receive the signals from the sensor unit (see Para. [0050]-[0051]) wherein the control unit is configured to output the displacement value (see Para. [0088]-[0091] mentioning where information from sensors is displayed on a display 40).
However, Buesseler does not expressly disclose:
wherein the displacement sensor comprises a housing positioned along the shaft;
wherein the sensor unit is positioned within or adjacent to the housing;
wherein the control unit is positioned within the housing;
wherein the control unit is configured to maintain a displacement value representing the detected displacement of the catheter within the lumen;
an input element on the housing; and
wherein the control unit is configured to reset the displacement value when the input element is actuated irrespective of the signals and continue maintaining the displacement value based on the signals received after the input element is actuated.
In the same field of endeavor, namely elongate tubular catheter devices, Dalal teaches an elongate catheter device (see Fig. 1) comprising a displacement sensor (sensor 102, see Para. [0026]-[0027]) that is mounted on a tracking housing (device 104, see Fig. 1 and Para. [0026]-[0027]) and comprises a controller positioned therein (see Para. [0026]) which may be modified to generate electromagnetic fields to provide additional displacement guidance (see Para. [0033]).
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 displacement sensor, sensor unit and control unit of Buesseler (i.e., the displacement sensing elements) to be positioned within or adjacent to the a housing positioned along the introducer, as taught and suggested by Dalal to, in this case, provide the position sensing elements within a common housing configured additionally to generate an electromagnetic field to further aid in tracking the displacement of the catheter within the introducer (see Dalal Para. [0026] and [0033]) in addition to protecting the sensor array from environment factors such as bodily fluids.
In the same field of endeavor, namely surgical elongate tubular devices configured to operate within a biological space, Rand teaches wherein an electronic circuit designed for measuring displacement of a prove tip may comprise a reset button which enables a user to reset the measurement(s) made regarding the displacement of the probe tip (see Col. 3, Lines 15-23) which would allow for a new reference location to be set.
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 housing of Buesseler, as incorporated from the teachings of Dalal, to further comprise a reset button thereon configured to enable a user to reset the currently-measured displacement value as taught and suggested by Rand (see Rand Col. 3, Lines 15-23) which would allow for a new reference location to be set. Since the reset button is external to the measurement system, the resetting functionality would occur irrespective of the currently-measured displacement value.
In the same field of endeavor, namely surgical catheter systems comprising displacement sensors and control units, Reisin teaches wherein a controller (control system, see Para. [0013], [0016] and [0018]) can receive information from a displacement sensor (see Para. [0016]) to, based on pre-set operational parameters, automatically adjust at least one operational parameter based on a machine learning software (i.e., displacement via displacement sensors) (see Para. [0016], [0018] and [0078]).
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 ECU of Buesseler to incorporate the machine learning software of Reisin therein to, in this case, based on changes recorded by the displacement sensor between the introducer sheath and the catheter, automatically adjust the displacement of the two components back to a pre-set displacement position to allow for a continuously-monitored system without relying on a user to provide manual input in response to a change in displacement recorded by the displacement sensor. This maintenance of a pre-set displacement value would correspond to the displacement detected and measured by the ECU of Buesseler since, whereas the ECU of Buesseler is configured to output a displacement value to a display (see Buesseler Para. [0088]-[0091]), the maintained, pre-set displacement value would also be continuously measured by the ECU of Buesseler whilst maintaining and adjusting the relative displacement between the catheter and introducer. Therefore any position of displacement, whether adjusted or maintained, is understood to be measured and output by the ECU of Buesseler, once modified by the machine learning software of Reisin.
Regarding claim 2, the combination of Buesseler, Dalal, Reisin and Rand disclose the invention of claim 1, Buesseler further discloses wherein the displacement sensor further comprises a display (display 40, see Fig. 1), and wherein outputting the displacement value comprises causing the displacement value to be displayed on the display (see Para. [0040] and [0088]-[0091]).
Regarding claim 3, the combination of Buesseler, Dalal, Reisin and Rand disclose the invention of claim 1, Buesseler further discloses wherein the introducer sheath further comprises the catheter (see Figs. 2A-2B showing wherein the catheter 56 is disposed within the shaft 66), wherein the catheter is disposed within the lumen (see Figs. 2A-2B) and configurated to receive a device, wherein the catheter comprises a guide catheter (see Buesseler Para. [0033] mentioning wherein the shaft of the device can be used with a guide sheath (i.e., guide catheter); the catheter of Buesseler may therefore take the form of a guide catheter), wherein the device comprises a microcatheter or guidewire (see Buesseler Para. [0033] mentioning wherein shaft can be used with a guidewire to navigate the device to a desired position).
Regarding claim 4, the combination of Buesseler, Dalal, Reisin and Rand disclose the invention of claim 1, Buesseler, as modified by Dalal further discloses wherein the sensor unit includes an inductive element, and wherein the signals representing the detected displacement represent variations in inductance (see Buesseler Para. [0089] mentioning wherein the sensor can include an inductive element to monitor the displacement and location of the catheter and introducer sheath via changes in inductance), wherein the inductive element is disposed within the housing and contacting an exterior wall of the shaft (the sensor elements of Buesseler are consolidated into the housing, as incorporated from the device of Dalal and any components thereof would also be located within the sensor housing, which is in contact with the introducer sheath which extends distally from said housing – the term “contacting” is interpreted to broadly include both direct abutments and indirect contacts until otherwise limited by the claim language).
Regarding claim 8, the combination of Buesseler, Dalal, Reisin and Rand disclose the invention of claim 1, Buesseler, as modified by Reisin, further discloses wherein the input element is a display (sensors of Buesseler is configured to send received information on any changes in displacement to a display 40 (vie ECU 42) as an input, see Buesseler Para. [0088]-[0091]) and wherein outputting the displacement value comprises causing the displacement value to be displayed on the display (the display 40 receives input from the sensor and provides a visual output of the displacement as a visual image for a user, see Buesseler Para. [0088]-[0091]).
Regarding claim 9, the combination of Buesseler, Dalal, Reisin and Rand disclose the invention of claim 1, Buesseler further discloses wherein the control unit is further configured to output an alarm in response to the displacement value being changed (see Buesseler Para. [0090] mentioning wherein the ECU may transmit changes in displacement as lights, vibration, or other feedback which constitute an alert to the user).
Regarding claim 10, the combination of Buesseler, Dalal, Reisin and Rand disclose the invention of claim 1.
However, none of either Buesseler, Dalal, Rand or Reisin, as currently presented, expressly disclose wherein the displacement sensor further comprises wireless circuitry within the housing, and wherein outputting the displacement value comprises causing the displacement value to be transmitted via the wireless circuitry to an external device.
However, Reisin teaches wherein the processor and sensor of the displacement system may be wirelessly coupled (see Para. [0114]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, as a matter of simple substitution of one known element for another (see KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007)) to have obtained the predictable result of having the sensors and ECU of the device of Buesseler to be wirelessly coupled together to send and receive data therebetween as disclosed by Reisin since Reisin discloses wherein a central processor and sensor “may” be coupled together in a wireless manner (see Reisin Para. [0114]). The use of the phrase “may” in the disclosure of Reisin indicates that this is not an important feature and one of ordinary skill in the art would have expected the device of Buesseler to operate properly with either a wired or wireless connection between the sensors and ECU since this is not indicated to be a critical feature and may be interchangeable between wired and wireless based upon the disclosure of Reisin.
Regarding claim 21, Buesseler discloses:
A method for tracking displacement of a catheter, the method comprising:
providing an introducer sheath (introducer 66, see Fig. 10B), comprising:
a hub (handle 24, see Fig. 1; the handle 24 is seen to be used with all catheter and introducer sheath embodiments unless otherwise stated) forming a proximal opening to a lumen (as the introducer sheath 66 is extends from the handle 24 and comprises an internal lumen (shown in Fig. 10B), the handle is seen to connect to a proximal end of the lumen of the introducer sheath 66);
a shaft extending distally from the hub (main body of the introducer sheath 66, see Fig. 10B which is seen to extend distally from the handle 24; this interpretation is consistent with the disclosure of the claimed invention in which the shaft (211) is the elongate body of the introducer sheath (210) as shown in Fig. 2 and recited in Para. [0024] of the Specification), the lumen extending through the shaft to form a distal opening (see Fig. 10B); and
a displacement sensor (sensor 70/70A, see Para. [0045]-[0046] and [0050] mentioning wherein sensor 70 can determine the location of the distal end of an internal catheter 56 relative to the distal end of the introducer 66 based on the relative distance(s) between the sensor 70 and longitudinal sensor members 58 positioned along the length of the catheter), comprising:
a sensor unit (position detection module, see Para. [0050]-[0051]) configured to detect displacement of a catheter (catheter 56, see Fig. 2A and 10B) within the lumen (see Fig. 2A and 10B, see also Para. [0050]-[0051]) and to output signals representing the detected displacement (see Para. [0050]-[0051]);
a control unit (ECU 42, see Fig. 1, see Para. [0050]-[0051]) that is configured to receive the signals from the sensor unit (see Para. [0050]-[0051]);
wherein the control unit is configured to output the displacement value (see Para. [0088]-[0091] mentioning where information from sensors is displayed on a display 40);
inserting the catheter into the lumen to a first position (see Para. [0008] mentioning wherein the device is configured to be positioned and located with at least a first position with a human body);
However, Buesseler does not expressly disclose:
wherein the displacement sensor comprises a housing positioned along the shaft;
wherein the sensor unit is positioned within or adjacent to the housing;
wherein the control unit is positioned within the housing;
wherein the control unit is configured to maintain a displacement value representing the detected displacement of the catheter within the lumen;
an input element on the housing; and
wherein the control unit is configured to reset the displacement value when the input element is actuated irrespective of the signals and continue maintaining the displacement value based on the signals received after the input element is actuated;
while the catheter is at the first position, actuating the input element a first time to reset the displacement value a first time;
advancing the catheter into the lumen until the displacement value reaches a desired value indicative of the catheter being at a second position in the lumen; and
while the catheter is at the second position, actuating the input element a second time to reset the displacement value a second time.
In the same field of endeavor, namely elongate tubular catheter devices, Dalal teaches an elongate catheter device (see Fig. 1) comprising a displacement sensor (sensor 102, see Para. [0026]-[0027]) that is mounted on a tracking housing (device 104, see Fig. 1 and Para. [0026]-[0027]) and comprises a controller positioned therein (see Para. [0026]) which may be modified to generate electromagnetic fields to provide additional displacement guidance (see Para. [0033]).
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 displacement sensor, sensor unit and control unit of Buesseler (i.e., the displacement sensing elements) to be positioned within or adjacent to the a housing positioned along the introducer, as taught and suggested by Dalal to, in this case, provide the position sensing elements within a common housing configured additionally to generate an electromagnetic field to further aid in tracking the displacement of the catheter within the introducer (see Dalal Para. [0026] and [0033]) in addition to protecting the sensor array from environment factors such as bodily fluids.
In the same field of endeavor, namely surgical elongate tubular devices configured to operate within a biological space, Rand teaches wherein an electronic circuit designed for measuring displacement of a prove tip may comprise a reset button which enables a user to reset the measurement(s) made regarding the displacement of the probe tip (see Col. 3, Lines 15-23) which would allow for a new reference location to be set during new, additional measurements (see Col. 3, Lines 23-30).
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 housing of Buesseler, as incorporated from the teachings of Dalal, to further comprise a reset button thereon configured to enable a user to reset the currently-measured displacement value as taught and suggested by Rand (see Rand Col. 3, Lines 15-23) which would allow for a new reference location to be set. Since the reset button is external to the measurement system, the resetting functionality would occur irrespective of the currently-measured displacement value. As modified by Rand, each position at which the device of Buesseler is positioned within the body can include a step of resetting the reference displacement value to zero to utilize each target position as a reference site for a given procedure (see Rand Col. 3, Lines 15-30]).
In the same field of endeavor, namely surgical catheter systems comprising displacement sensors and control units, Reisin teaches wherein a controller (control system, see Para. [0013], [0016] and [0018]) can receive information from a displacement sensor (see Para. [0016]) to, based on pre-set operational parameters, automatically adjust at least one operational parameter based on a machine learning software (i.e., displacement via displacement sensors) (see Para. [0016], [0018] and [0078]).
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 ECU of Buesseler to incorporate the machine learning software of Reisin therein to, in this case, based on changes recorded by the displacement sensor between the introducer sheath and the catheter, automatically adjust the displacement of the two components back to a pre-set displacement position to allow for a continuously-monitored system without relying on a user to provide manual input in response to a change in displacement recorded by the displacement sensor. This maintenance of a pre-set displacement value would correspond to the displacement detected and measured by the ECU of Buesseler since, whereas the ECU of Buesseler is configured to output a displacement value to a display (see Buesseler Para. [0088]-[0091]), the maintained, pre-set displacement value would also be continuously measured by the ECU of Buesseler whilst maintaining and adjusting the relative displacement between the catheter and introducer. Therefore any position of displacement, whether adjusted or maintained, is understood to be measured and output by the ECU of Buesseler, once modified by the machine learning software of Reisin.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Buesseler (US 2018/0228395 A1)(previously of record) in view of Reisin (US 2021/0007760 A1) (previously of record), further in view of Dalal (US 2014/0171792 A1)(previously of record), further in view of Rand (US 4979898 A), as applied to claim 1, further in view of Barrish (US 2017/0157361 A1) (previously of record), further in view of Moore (US 2018/0261237 A1)(previously of record).
Regarding claim 5, the combination of Buesseler, Dalal, Rand and Reisin disclose all of the limitations of the invention of claim 1, Buesseler further discloses wherein the introducer sheath further comprises the catheter (see Fig. 10B), wherein the catheter is disposed within the lumen and configured to receive a device (see Fig. 10B), wherein the catheter comprises a plurality of markings spaced apart along a length of the catheter (sensors 58A, see Figs. 2A-2B), wherein the sensor (70/70A) of the introducer is configured to detect displacement by measuring the proximity of the sensors (58B) of the catheter in relation thereto (see Para. [0055]).
However, none of either Buesseler, Dalal, Rand or Reisin expressly discloses wherein the sensor unit includes one or more optical sensors, and wherein the signals representing the detected displacement represent light received by the one or more optical sensors wherein the one or more optical sensors are disposed within a wall of the shaft and proximate the housing, wherein the markings are configured to reflect light emitted by the one or more optical sensors such that the markings are detected by the one or more optical sensors.
In the same field of endeavor, namely articulation systems and methods for catheter systems, Barrish teaches wherein optical sensors can be utilized to determine and track axial displacement or movement of a catheter relative to an introducer to measure displacement between the two devices and transmit commands in response thereto (see Para. [0132]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, as a matter of simple substitution of one known element for another (see KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 416, 82 USPQ2d 1385, 1395 (2007)) to obtain the predictable result of having an optical sensor to detect displacement of the catheter via light received by the optical sensor, as disclosed by Barrish because Buesseler discloses wherein the displacement of the catheter can include other types of signal typically generated by a sensor that can be used to detect movement and/or proximity of a sensor member (see Buesseler Para. [0089]), indicating that the displacement sensor of Buesseler may be interchangeable with other types of sensors, including the optical sensor of Barrish which also measures displacement of a catheter relative to an introducer by detecting changes in wavelength, frequency or polarization of light to be sent to the ECU to make corrective adjustments in response thereto through (see Barrish Para. [0132], noting that optical sensors inherently operate by measuring changes in wavelength, frequency or polarization of light). As both sensor types are configured to detect displacement of a catheter within an introducer, in combination with Buesseler’s disclosure that one sensor may be interchangeable for another, one of ordinary skill in the art would have expected the device of Buesseler to function equally well with either the displacement sensor of Buesseler, or the optical sensor of Barrish. In this combination, should the sensor (70A) of Buesseler be an optical sensor, in order for the function of the detection mechanism to remain functional, the sensors (58A) of the catheter would be subjected to polarizing light and the reflection of this light would be used to determine the relative distances between the sensor (70A) of the introducer and the sensors of the internal catheter. This is understood to be an obvious change since the sensors of the catheter are also disclosed to be able to, broadly, be formed from material that facilitates detection by the sensor of the introducer sheath (see Buesseler Para. [0054]) and would thus be formed from a material the at least partially reflects light so as to enable the detection mechanism of Buesseler to operate normally with the obvious substitution to an optical-based system.
In the field of endeavor of optical sensors, Moore teaches wherein optical sensor elements require a direct line-of-sight to operate (see Para. [0004]) and thus the examiner notes that any optical sensor would need to have direct sight with the element that is tracked and would thus need to be positioned within the exterior wall of the shaft (66) within the area disposed radially-inward of the housing in order to operate effectively.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Buesseler (US 2018/0228395 A1) (previously of record) in view of Reisin (US 2021/0007760 A1) (previously of record), further in view of Dalal (US 2014/0171792 A1)(previously of record), further in view of Rand (US 4979898 A), further in view of Van Egmond (US 5709661 A) (previously of record).
Regarding claim 6, the combination of Buesseler, Dalal, Rand and Reisin disclose all of the limitations of the invention of claim 1.
However, none of either Buesseler, Dalal, Rand or Reisin expressly disclose wherein the sensor unit includes one or more rollers, and wherein the signals representing the detected displacement represent rotation of the one or more rollers, wherein the one or more rollers extend through a sidewall of the shaft such that the one or more rollers are disposed partially within the lumen and partially within the housing.
However, in the same field of endeavor, namely catheter systems with sensors measuring displacement, Van Egmond teaches wherein a displacement sensing roller and idle roller between which a catheter can be advanced or retracted (see Col. 2, Lines 44-54) can be used to measure the displacement of a catheter (see Col. Col. 2, Lines 44-54, see also Col. 3, Lines 59-67 and Col. 4, Lines 1-16), wherein the catheter is in direct contact with and rotated between the pair of rollers in order to track displacement thereof (see Col. 3, Lines 58-64, see also Figs. 4-5)
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, as a matter of simple substitution of one known element for another (see KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 416, 82 USPQ2d 1385, 1395 (2007)) to obtain the predictable result of having the sensor unit of Buesseler include one or more rollers, and wherein the signals representing the detected displacement represent rotation of the one or more rollers as disclosed by Van Egmond because Buesseler discloses wherein the displacement of the catheter can include other types of signal typically generated by a sensor that can be used to detect movement and/or proximity of a sensor member (see Buesseler Para. [0089]), indicating that the displacement sensor of Buesseler may be interchangeable with other types of sensors, including the roller elements of Van Egmond which also measure the displacement of a catheter (see Col. Col. 2, Lines 44-54, see also Col. 3, Lines 59-67 and Col. 4, Lines 1-16) via movement of the catheter along said rollers. As both sensor types are configured to detect displacement of a catheter within an introducer, in combination with Buesseler’s disclosure that one sensor may be interchangeable for another, one of ordinary skill in the art would have expected the device of Buesseler to function equally well with either the displacement sensor of Buesseler, or the roller system of Van Egmond. The resulting combination would yield a roller assembly that is partially disposed within the lumen of the introducer, so as to contact and detect displacement of the catheter disposed therein, and partially exposed from the lumen since the rollers need to be in communication with an actuation element disposed within the handpiece, outside the lumen of the introducer so as to be in communication with the actuation mechanism, as can be seen in Van Egmond Fig. 1.
Claim(s) 11-13 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Buesseler (US 2018/0228395 A1) (previously of record) in view of Reisin (US 2021/0007760 A1) (previously of record), further in view of Rand (US 4979898 A).
Regarding claim 11, Buesseler discloses:
An introducer sheath (introducer 66, see Fig. 10B) comprising:
a hub (handle 24, see Fig. 1; the handle 24 is seen to be used with all catheter and introducer sheath embodiments unless otherwise stated) forming a proximal opening to a lumen (as the introducer sheath 66 is extends from the handle 24 and comprises an internal lumen (shown in Fig. 10B), the handle is seen to connect to a proximal end of the lumen of the introducer sheath 66);
a shaft extending distally from the hub (main body of the introducer sheath 66, see Fig. 10B which is seen to extend distally from the handle 24; this interpretation is consistent with the disclosure of the claimed invention in which the shaft (211) is the elongate body of the introducer sheath (210) as shown in Fig. 2 and recited in Para. [0024] of the Specification), the lumen extending through the shaft to form a distal opening (see Fig. 10B); and
a displacement sensor (sensor 70/70A, see Para. [0045]-[0046] and [0050] mentioning wherein sensor 70 can determine the location of the distal end of an internal catheter 56 relative to the distal end of the introducer 66 based on the relative distance(s) between the sensor 70 and longitudinal sensor members 58 positioned along the length of the catheter), comprising:
a sensor unit (position detection module, see Para. [0050]-[0051]) positioned to detect displacement of a catheter (catheter 56, see Fig. 2A and 10B) within the lumen (see Fig. 2A and 10B, see also Para. [0050]-[0051]) and to output signals representing the detected displacement (see Para. [0050]-[0051]); and
a control unit (ECU 42, see Fig. 1, see Para. [0050]-[0051]) that is configured to receive the signals from the sensor unit (see Para. [0050]-[0051]); and
a display (display 40, see Fig. 1) on which the control unit displays the displacement value (see Para. [0088]-[0091] mentioning where information from sensors is displayed on a display 40 by the ECU).
However, while Buesseler discloses wherein sensors 70 are configured to display displacement data collected to ECU controller 42 (see Para. [0050]-[0051] and [0088]-[0091]), Buesseler does not expressly disclose:
wherein the control unit is configured to maintain a displacement value based on the signals representing the detected displacement of the catheter within the lumen;
an input element; and
wherein the control unit is configured to reset the displacement value when the input element is actuated irrespective of the signals and continue maintaining the displacement value based on the signals received after the input element is actuated.
In the same field of endeavor, namely surgical catheter systems comprising displacement sensors and control units, Reisin teaches wherein a controller (control system, see Para. [0013], [0016] and [0018]) can receive information from a displacement sensor (see Para. [0016]) to, based on pre-set operational parameters, automatically adjust at least one operational parameter based on a machine learning software (i.e., displacement via displacement sensors) (see Para. [0016], [0018] and [0078]).
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 ECU of Buesseler to incorporate the machine learning software of Reisin therein to, in this case, based on changes recorded by the displacement sensor between the introducer sheath and the catheter, automatically adjust the displacement of the two components back to a pre-set displacement position to allow for a continuously-monitored system without relying on a user to provide manual input in response to a change in displacement recorded by the displacement sensor. This maintenance of a pre-set displacement value would correspond to the displacement detected and measured by the ECU of Buesseler since, whereas the ECU of Buesseler is configured to output a displacement value to a display (see Buesseler Para. [0088]-[0091]), the maintained, pre-set displacement value would also be continuously measured by the ECU of Buesseler whilst maintaining and adjusting the relative displacement between the catheter and introducer. Therefore any position of displacement, whether adjusted or maintained, is understood to be measured and output by the ECU of Buesseler, once modified by the machine learning software of Reisin.
In the same field of endeavor, namely surgical elongate tubular devices configured to operate within a biological space, Rand teaches wherein an electronic circuit designed for measuring displacement of a prove tip may comprise a reset button which enables a user to reset the measurement(s) made regarding the displacement of the probe tip (see Col. 3, Lines 15-23) which would allow for a new reference location to be set.
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 housing of Buesseler, as incorporated from the teachings of Dalal, to further comprise a reset button thereon configured to enable a user to reset the currently-measured displacement value as taught and suggested by Rand (see Rand Col. 3, Lines 15-23) which would allow for a new reference location to be set. Since the reset button is external to the measurement system, the resetting functionality would occur irrespective of the currently-measured displacement value.
Regarding claim 12, the combination of Buesseler, Reisin and Rand disclose the invention of claim 11, Buesseler further discloses wherein the sensor unit includes an inductive element that is positioned adjacent the lumen, wherein the signals representing the detected displacement represent variations in inductance of the inductive element caused when the catheter is displaced within the lumen (see Para. [0045] mentioning wherein the displacement sensor is positioned in the introducer, see also Para. [0089] mentioning wherein the sensor can include an inductive element to monitor the displacement and location of the catheter and introducer sheath via changes in inductance).
Regarding claim 13, the combination of Buesseler, Reisin and Rand disclose the invention of claim 12, Buesseler further discloses wherein the introducer sheath further comprises the catheter (see Fig. 2A and 10B) and another catheter, wherein the catheter is positioned within the other catheter within the lumen (see Buesseler Para. [0033] mentioning wherein the shaft can be used with a guide sheath (i.e., guide catheter) and a guidewire and is thus fully capable of being used with a guide catheter and guide wire. The examiner notes that as the catheter is only functionally claimed in claim 11, the catheter of Buesseler merely needs to be capable of being used in the recited manner.
Regarding claim 17, the combination of Buesseler, Reisin and Rand disclose the invention of claim 11, Buesseler, as modified by Rand, further discloses wherein the display comprises the input element (as the reset button Rand, as incorporated into the device of Buesseler, resets the relative displacement value between the introducer and catheter back to zero, the display would be affected since the input to-be-displayed would be changed; therefore, the reset button is a part of the display circuitry).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Buesseler (US 2018/0228395 A1) (previously of record) in view of Reisin (US 2021/0007760 A1) (previously of record), further in view of Rand (US 4979898 A), as applied to claim 11, further in view of Syed (US 2019/0298182 A1) (previously of record).
Regarding claim 14, the combination of Buesseler, Reisin and Rand disclose all of the limitations of the invention of claim 11.
However, none of either Buesseler, Rand or Reisin expressly disclose wherein the sensor unit includes one or more optical sensors, and wherein the signals representing the detected displacement represent light reflected from markings on the catheter when the catheter is displaced within the lumen.
However, in the same field of endeavor, namely catheter systems comprising sensors for measuring displacement, Syed teaches a catheter system (see Fig. 1) comprising an optical sensor (optical sensors A and B, see Para. [0091] and [0092]) is configured to measure light reflect from markings (optical markings 1910, see Para. [0091]-[0092]) on an elongate tubular member (guidewire, see Para. [0091]-[0092], noting that light is reflected off of the markings 1910 while being recorded by the sensors) to detect displacement of the elongate member based on the location of the optical markings 1910 in relation to the sensors (see Para. [0091]-[0092]).
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 catheter system of Buesseler to have the catheter 56 comprise a series of optical markings to be detected via an optical sensor within the system as taught and suggested by Syed to, in this case, measure the displacement of the catheter of Buesseler in relation to the location of the optical sensors to measure axial displacement of the catheter (see Syed Para. [0091]-[0092]).
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Buesseler (US 2018/0228395 A1) (previously of record) in view of Reisin (US 2021/0007760 A1) (previously of record), further in view of Rand (US 4979898 A), further in view of Van Egmond (US 5709661 A) (previously of record).
Regarding claim 15, the combination of Buesseler, Reisin and Rand disclose all of the limitations of the invention of claim 11.
However, none of either Buesseler, Rand or Reisin expressly disclose wherein the sensor unit includes one or more rollers, and wherein the signals representing the detected displacement represent rotation of the one or more rollers caused by the catheter when the catheter is displaced within the lumen.
However, in the same field of endeavor, namely catheter systems with sensors measuring displacement, Van Egmond teaches wherein a displacement sensing roller and idle roller between which a catheter can be advanced or retracted (see Col. 2, Lines 44-54) can be used to measure the displacement of a catheter (see Col. Col. 2, Lines 44-54, see also Col. 3, Lines 59-67 and Col. 4, Lines 1-16).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, as a matter of simple substitution of one known element for another (see KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 416, 82 USPQ2d 1385, 1395 (2007)) to obtain the predictable result of having the sensor unit of Buesseler include one or more rollers, and wherein the signals representing the detected displacement represent rotation of the one or more rollers as disclosed by Van Egmond because Buesseler discloses wherein the displacement of the catheter can include other types of signal typically generated by a sensor that can be used to detect movement and/or proximity of a sensor member (see Buesseler Para. [0089]), indicating that the displacement sensor of Buesseler may be interchangeable with other types of sensors, including the roller elements of Van Egmond which also measure the displacement of a catheter (see Col. Col. 2, Lines 44-54, see also Col. 3, Lines 59-67 and Col. 4, Lines 1-16) via movement of the catheter along said rollers. As both sensor types are configured to detect displacement of a catheter within an introducer, in combination with Buesseler’s disclosure that one sensor may be interchangeable for another, one of ordinary skill in the art would have expected the device of Buesseler to function equally well with either the displacement sensor of Buesseler, or the roller system of Van Egmond.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s
disclosure. See the attached PTO-892 Notice of References Cited. Specifically, US 6398755 B1 to Belef, US 20070000498 A1 to Glynn, US 20150216473 A1 to Yu, US 8970207 B2 to Baumgartner and US 5957869 A to Caruso all disclose surgical devices comprising a displacement sensor with a reset function to designate a desired relative position of the surgical device as a reference displacement position.
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.
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/M.B.H./Examiner, Art Unit 3771
/SHAUN L DAVID/Primary Examiner, Art Unit 3771