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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on July 29th, 2026 has been entered.
Claim Status
Claim amendments submitted on July 29th, 2026 have been entered. Claims 1-5 and 7-21 are currently pending. Claim 21 has been newly added. Claims 1, 9, and 16 have been amended. Claim 21 has been newly added. Claims 1-5 and 7-21 are thus under consideration.
Response to Arguments
Applicant's arguments filed July 29th, 2026 have been fully considered but they are not persuasive. The present rejection detailed below relies upon a different primary reference than the previous rejection and as such the arguments pertaining to Muller, U.S. Publication 2017/0028115, are not drawn toward the reference of the current rejection Muller et al., U.S. Publication 2018/0021495) and are therefore considered moot and any deficiencies argued by applicant of the previous rejection are seen to be addressed by the newly presented prior art detailed in the below rejection.
Applicant’s argument pertaining to Muller (U.S. Publication 2017/0028115) not suggesting anywhere in its text that it is possible for air to be trapped in the cavities of the flow diverter have been addressed by Walters et al. (U.S. Publication 2012/0178985) teaching the possibility of air trapped in return side of fluid flow.
Applicant’s argument pertaining to Muller (U.S. Publication 2017/0028115) not suggesting any particular orientation which would prevent air from being trapped in the cavities of the flow diverter or aid in releasing air trapped in the cavities of the flow diverter or any other structure of Muller, is also addressed by Walters et al. (U.S. Publication 2012/0178985) teaching the upward position to aid in purging of air.
Applicant’s argument that the geometry of internal cavities of flow diverter are neither described nor illustrated in Muller, is seen to be addressed in the newly presented Muller et al. reference below which details the structure of the cavities in Fig. 4A.
Regarding applicant’s arguments pertaining to Battiato and Popa, applicant has argued that neither references suggest any reason to arrange the tilt sensor of Battiato with a device such as Muller, which is substantially similar to the device of the newly presented reference, however examiner respectfully disagrees in that Muller (U.S. Publication 2018/0021495) describes the need to purge air from a system and Battiato expressly teaches that the use of its procedure including the tilt sensor allows for a more complete removal of air from the system for the purpose of reducing the potential for accidently injecting air into a patient and as such is seen to provide sufficient reasoning for one of ordinary skill in the art to provide a tilt sensor in a device such as Muller (U.S. Publication 2018/0021495), furthermore Walters (U.S. Publication 2012/0178985), as applied in the rejection of claim 1 below, in the same field of endeavor of intravascular blood pumps, teaches that the catheter should be held in an upward position during purging and that both supply and return fluid lines should be primed to remove air from both positioned providing further motivation to one of ordinary skill in the art to modify the device of Muller (U.S. 2018/0021495) with the teaching of Battiato and Popa.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-5, 7, 9-14, 16-19, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Muller et al. (U.S. Publication 2018/0021495) in view of Battiato (U.S. Patent No. 5,868,710) henceforth referred to as Battiato and further in view of Walters et al. (U.S. Publication 2012/0178985) and Popa et al. (U.S. Publication 2021/0244434).
Regarding claim 1, A system (Figs. 1B, 2, and 4A), comprising:
a catheter 100A, the catheter comprising an elongate tubular portion 120A;
a first connected device 3, the elongate tubular portion configured to be inserted into a patient's blood vessel (¶0056 into a peripheral blood vessel and along the path between that blood vessel and the heart and into a heart chamber) and having a proximal end (¶0051 catheter body extend proximally and couple to the motor assembly, proximal end (end coupled to motor assembly at 19) and a distal end 170A and a lumen 57 extending from the proximal end to the distal end (¶0018 catheter body having a lumen in which fluid flows proximally therethrough; ¶0065 supplied fluid can travel distally toward the impeller assembly 116A to lubricate rotating components in the catheter assembly and/or supply fluid to the patient), the first connected device connected to the proximal end of the elongate tubular portion (Fig. 1B shows connection of 4 to proximal end of 120A; Fig. 4A shows connection of lumen at 19) and having at least one cavity 4, wherein the at least one cavity is in fluid communication with the lumen of the elongate tubular portion (¶0066 after initially cooling distal components some or all of the supplied fluid 35 can flow in a space disposed radially between the drive shaft and the catheter body 120A. The proximally-flowing fluid can flow along a flow pathway which removes heat from the motor assembly. As shown in Fig. 4A, the proximally-flowing fluid (or other cooling fluid) can flow into the rotor chamber of the flow diverter 3).
Muller further discloses expelling air from the impeller assembly through the use of an infusate (¶0049 introducing fluid into the sealed priming apparatus to expel air…fluid can be introduced distally through the elongate body 174A), e.g., any air that is trapped within the housing or that remains within the elongate body near the distal end so that air bubbles are not allowed to enter and/or injure the patient (¶0048), as well as supplied fluid being delivered through internal cavities of the driven assembly, i.e. first connected device (¶0066 after initially cooling distal components some or all of the supplied fluid 35 can flow in a space disposed radially between the drive shaft and the catheter body 120A. The proximally-flowing fluid can flow along a flow pathway which removes heat from the motor assembly. As shown in Fig. 4A, the proximally-flowing fluid (or other cooling fluid) can flow into the rotor chamber of the flow diverter 3)).
Muller does not expressly disclose the full extent of what the procedure to expel that air is or the system comprising at least one sensor arrange in the first connected device and configured to detect an orientation of the first connected device; or a control unit configured to: receive data from the at least one sensor including a detected orientation of the first connected device, and concurrently display, on a user interface, (i) a visual representation of the detected orientation, and (ii) a visual representation of a predetermined orientation of the first connected device.
However, Battiato, in the same field of endeavor of detecting the orientation of a device, teaches a procedure to expel air (Col. 19 lines 57-67, remove air from syringe) from a system that includes providing a sensor (158) in communication (Col. 19 lines 49-56, receives signal from tilt sensor) with a control unit (CPU 175) for detecting an orientation of a connected device (Col. 19 lines 49-56, indicative of the angle relative to Earth gravity), the control unit configured to: receive data from the sensor (Col. 19 lines 49-56, receives signal from tilt sensor) including the orientation detected by the sensor (Col. 19 lines 49-67 175 receives signal from tilt sensor indicative of the angle relative to earth gravity, determines angle with respect to Earth gravity), and displaying a representation of the detected orientation and a representation of a predetermined orientation (Col. 19 lines 49-67 and Col. 20 lines 1-35, the controller determines/controls how the device may function based on the region the angle is determined to be within, the lack of ability of an operator to perform the actions described in Col. 19 line 49 to Col. 20 line 35 displays to the user a representation of both the detected orientation and the predetermined orientations which include Regions 1-4 of Fig. 13A, for example if the power head has a detected orientation with the predetermined orientation of Region 1 the operator will be able to fill the syringe, displaying to the user that the detected orientation is within the predetermined orientation of Region 1) for the purpose of reducing the potential for accidently injecting air into a patient (Col. 1 lines 22-33) by controlling function of the device based on the angle at which the device is positioned (Col. 19 lines 57-67, allows operator to remove air when positioned within region 1 or regions 2a or 2b and preventing other protocols from being initiated until moved into region 4 Col. 20 lines 1-16) and providing warnings to operator when the device is tilted in a certain range.
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 device of Mueller to have included the sensor and controller of Battiato for the purpose of implementing a procedure of expelling air out of the system that reduced the potential for accidently injecting air into a patient by indicating to the user a tilt angle of the device and controlling functions of the device based on the angle at which the device is positioned such that priming of the device could be performed an angle sufficient to expel all the air from the device and use of the device could be prevented until such angle and subsequent priming had occurred.
While Muller in view of Battiato do not expressly disclose the point in the system at which the sensor would be positioned and therefore do not expressly disclose the sensor being for detecting an orientation of the first connected device at the proximal end, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have positioned the sensor to detect the orientation of the first connected device disclosed by Muller as the first connected device is configured to have internal cavities that are in fluid communication with the patient during the procedure and is fluidly connected to the catheter in such a manner that any air present in these cavities would be at risk of entering the patient (¶0051 fluid supply device is configured to allow for fluid to enter the catheter assembly of the catheter pump and/or for waste fluid to leave the catheter assembly of the catheter pump; ¶0065 supplied fluid can travel distally toward the impeller assembly to lubricate rotating components in the catheter assembly and supply fluid to the patient…¶0066 fluid from the catheter pump can flow proximally through an inner lumen of the catheter body. For example, after initially cooling distal components some or all of the supplied fluid can flow within the drive shaft and/or around the periphery of the drive shaft. After initially cooling distal components some or all of the supplied fluid can flow in a space disposed radially between the drive shaft and the3 catheter body. The proximally flowing fluid can flow along a flow pathway which removes heat from the motor assembly. As shown in Fig. 4A, the proximally-flowing fluid can flow into the rotor chamber of the flow diverter.)) and as such one would have been motivated to provide the sensor disclosed by Battiato such that the orientation of the first connected device could be detected or the purpose of implementing a procedure of expelling air out of the system that reduced the potential for accidently injecting air into a patient by indicating to the user a tilt angle of the device and controlling functions of the device based on the angle at which the device is positioned such that priming of the device could be performed an angle sufficient to expel all the air from the device and use of the device could be prevented until such angle and subsequent priming had occurred.
Furthermore, Walters et al., in the same field of endeavor of blood pumps, teaches providing infusant for expelling air from the pump (¶0169 expulsion of air from the heart pump) down both the delivery flow path and return flow path (¶0169 infusant flow path down both the delivery flow path and return flow path) and placing the heart pump in a vertical position (¶0170 heart pump can be held vertically with the distal tip of the impeller upward so that air bubbles can float out) for the purpose of improving air expulsion by providing multiple pathways via which the infusant can flow to displace the air (¶0173 multiple pathways via which the infusant can flow to displace the air and expel it from the catheter) as air can be trapped along the infusant return flow path rather than expelled (¶0172 air that is not removed from the pump catheter body can be trapped (such as in the infusant return line) and insuring the heart pump is in a position that allows air bubbles to float out of the device (¶0170 heart pump can be held vertically with the distal tip of the impeller upward so that air bubbles can float out).
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 device of Muller with the teachings of Battiato as Walters has described the potential problem of air being trapped downstream in the return flow path and as such one would have been motivated to provide the device of Battiato in the first connected device for the purpose of ensuring that the chambers of the first connected device are placed into an upright vertical position as Walters has taught that this placement allows air bubbles to float out of the device prior to inserting the heart pump into the patient (¶0170).
Muller in view of Battiato fail to disclose or suggest the displayed representation of the detected and predetermined orientations being visual representations displayed concurrently on the user interface.
However, Popa, in the same field of endeavor of catheter position detection, teaches a display 506 wherein a visual representation of a detected catheter orientation (arrow 526) is displayed concurrently with a visual representation of a predetermined orientation (¶0143 pre-defined orientation relative to one another, reference mark orientation 524) for the purpose of clearly displaying to the operator which direction to rotate the source catheter to attain alignment (¶0145).
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 device suggested by Muller in view of Battiato to have displayed a visual representation of the detected orientation concurrently with the reference orientations established in Fig. 13a of Battiato for the purpose of clearly displaying to the operator which direction to rotate the catheter in order to attain alignment of the device, as taught by Popa in ¶0145.
Regarding claim 2, Muller in view of Battiato and further in view of Popa and Walters suggest the system of claim 1. Battiato further suggests the control unit 175 being configured to determine whether the detected orientation matches the predetermined orientation wherein air is releasable from the at least one cavity (Col. 19 lines 49-67 175 receives signal from tilt sensor indicative of the angle relative to earth gravity, determines angle with respect to Earth gravity and determines how the device may function based on the region the angle is determined to be within. Regions 1, 2a and 2b are determined to be regions in which air is releasable, allows for removal of air in these regions and therefore determines whether the detected orientation matches on of these region orientations). Thus, it would be obvious to one of skill in the art to provide the above combination of elements and features, and one of skill would have been motivated to do so.
Regarding claim 3, Muller in view of Battiato and further in view of Popa and Walters suggest the system of claim 1. Battiato further suggests the control unit being configured to compute a difference of the detected orientation and the predetermined orientation to guide a user to change the orientation of the first connected device in order to approach the predetermined orientation (CPU computes detected orientation against predetermined orientation, if not in proper region of orientation the system will not allow the user to perform certain functions, this inability to perform functions guides user to change orientation in order to perform the function). Furthermore, Popa further teaches displaying the measured alignment angle through calculation of the alignment angle by a processor (¶0143). Thus, it would be obvious to one of skill in the art to provide the above combination of elements and features, and one of skill would have been motivated to do so as in order to display the alignment angle of the detected orientation to the predetermined orientation the control unit must first process the sensed orientation and calculate the alignment angle of the sensed orientation to the reference orientation in order to provide the concurrent representation.
Regarding claim 4, Muller in view of Battiato and further in view of Popa and Walters suggest the system of claim 1. Battiato and Popa further suggests the control unit being configured to display a first indicator indicating matching of the detected orientation with the predetermined orientation (controller of Battiato prevents purging of air from the system until positioned in Region 1, 2a, or 2b which displays the indicator of the system not allowing the function to the user) and a second indicator indicating a difference between the detected orientation and the predetermined orientation (display of the detected orientation concurrently with the predetermined orientation inherently indicates a difference between them to the user through their respective displayed orientation to one another). Thus, it would be obvious to one of skill in the art to provide the above combination of elements and features, and one of skill would have been motivated to do so.
Regarding claim 5, Muller in view of Battiato and further in view of Popa and Walters suggest the system of claim 3. Battiato further suggests the predetermined orientation being a conical range around a vertical axis defined by a predetermined angle (Regions 1, 2a, and 2b represent range of angles around a vertical axis that is representative of a conical shape around the vertical axis). Thus, it would be obvious to one of skill in the art to provide the above combination of elements and features, and one of skill would have been motivated to do so.
Regarding claim 7, Muller in view of Battiato and further in view of Popa and Walters suggest the system of claim 1. Battiato further suggests the sensor including an accelerometer (Col. 15 lines 20-31). Thus, it would be obvious to one of skill in the art to provide the above combination of elements and features, and one of skill would have been motivated to do so.
Regarding claim 9, Muller discloses A method (¶0048 primed with fluid) of preparing a catheter 100A for use in a patient,
the catheter comprising an elongate tubular portion 120A and a first connected device 3, the elongate tubular portion being configured to be inserted into a blood vessel of the patient's blood vessel (¶0056 into a peripheral blood vessel and along the path between that blood vessel and the heart and into a heart chamber) and having a proximal end (¶0051 catheter body extend proximally and couple to the motor assembly) and a distal end 170A and a lumen 57 extending from the proximal end to the distal end (¶0018 catheter body having a lumen in which fluid flows proximally therethrough; ¶0065 supplied fluid can travel distally toward the impeller assembly 116A to lubricate rotating components in the catheter assembly and/or supply fluid to the patient), wherein a the first connected device is connected to the proximal end of the elongate tubular portion (Fig. 1B shows connection of 4 to proximal end of 120A; Fig. 4A shows connection of lumen at 19) and having the first connected device has at least one cavity 4, wherein the at least one cavity is in fluid communication with the lumen of the elongate tubular portion (¶0066 after initially cooling distal components some or all of the supplied fluid 35 can flow in a space disposed radially between the drive shaft and the catheter body 120A. The proximally-flowing fluid can flow along a flow pathway which removes heat from the motor assembly. As shown in Fig. 4A, the proximally-flowing fluid (or other cooling fluid) can flow into the rotor chamber of the flow diverter 3),the method comprising the steps of supplying a fluid into the at least one cavity of the first connected device (¶0066 after initially cooling distal components some or all of the supplied fluid 35 can flow in a space disposed radially between the drive shaft and the catheter body 120A. The proximally-flowing fluid can flow along a flow pathway which removes heat from the motor assembly. As shown in Fig. 4A, the proximally-flowing fluid (or other cooling fluid) can flow into the rotor chamber of the flow diverter 3) and the lumen of the elongate tubular portion (¶0065 supplied from a source to an outer lumen of the catheter body) to purge the at least one cavity and the lumen (¶0048 primed with fluid…to expel air from the impeller assembly).
Muller further discloses expelling air from the impeller assembly through the use of an infusate (¶0049 introducing fluid into the sealed priming apparatus to expel air…fluid can be introduced distally through the elongate body 174A), e.g., any air that is trapped within the housing or that remains within the elongate body near the distal end so that air bubbles are not allowed to enter and/or injure the patient (¶0048), as well as supplied fluid being delivered through internal cavities of the driven assembly, i.e. first connected device (¶0066 after initially cooling distal components some or all of the supplied fluid 35 can flow in a space disposed radially between the drive shaft and the catheter body 120A. The proximally-flowing fluid can flow along a flow pathway which removes heat from the motor assembly. As shown in Fig. 4A, the proximally-flowing fluid (or other cooling fluid) can flow into the rotor chamber of the flow diverter 3)).
Muller does not expressly disclose detecting, with at least one sensor arranged in the first connected device, an orientation of at least one of the elongate tubular portion and the at least one connected device, and concurrently displaying, on a user interface, a visual a representation of the detected orientation and a visual representation of a predetermined orientation of the first connected device.
However, Battiato, in the same field of endeavor of detecting the orientation of a device, discloses a procedure to expel air (Col. 19 lines 57-67, remove air from syringe) from a system that includes providing sensor (158) in communication (Col. 19 lines 49-56, receives signal from tilt sensor) with a control unit (CPU 175) for detecting an orientation of a connected device (Col. 19 lines 49-56, indicative of the angle relative to Earth gravity), the control unit configured to: receive data from the sensor (Col. 19 lines 49-56, receives signal from tilt sensor) including the orientation detected by the sensor (Col. 19 lines 49-67 175 receives signal from tilt sensor indicative of the angle relative to earth gravity, determines angle with respect to Earth gravity), and displaying a representation of the detected orientation and a representation of a predetermined orientation (Col. 19 lines 49-67 and Col. 20 lines 1-35, the controller determines/controls how the device may function based on the region the angle is determined to be within, the lack of ability of an operator to perform the actions described in Col. 19 line 49 to Col. 20 line 35 displays to the user a representation of both the detected orientation and the predetermined orientations which include Regions 1-4 of Fig. 13A, for example if the power head has a detected orientation with the predetermined orientation of Region 1 the operator will be able to fill the syringe, displaying to the user that the detected orientation is within the predetermined orientation of Region 1) for the purpose of reducing the potential for accidently injecting air into a patient (Col. 1 lines 22-33) by controlling function of the device based on the angle at which the device is positioned (Col. 19 lines 57-67, allows operator to remove air when positioned within region 1 or regions 2a or 2b and preventing other protocols from being initiated until moved into region 4 Col. 20 lines 1-16) and providing warnings to operator when the device is tilted in a certain range.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modified the method of Mueller to have included the step of detecting an orientation of at least one of the elongate tubular portion and the at least one connected device; and displaying a representation of the detected orientation and a representation of a predetermined orientation through the inclusion of the sensor and controller of Battiato for the purpose of implementing a procedure of expelling air out of the system that reduced the potential for accidently injecting air into a patient by indicating to the user a tilt angle of the device and controlling functions of the device based on the angle at which the device is positioned such that priming of the device could be performed an angle sufficient to expel all the air from the device and use of the device could be prevented until such angle and subsequent priming had occurred.
Furthermore, Walters et al., in the same field of endeavor of blood pumps, teaches providing infusant for expelling air from the pump (¶0169 expulsion of air from the heart pump) down both the delivery flow path and return flow path (¶0169 infusant flow path down both the delivery flow path and return flow path) and placing the heart pump in a vertical position (¶0170 heart pump can be held vertically with the distal tip of the impeller upward so that air bubbles can float out) for the purpose of improving air expulsion by providing multiple pathways via which the infusant can flow to displace the air (¶0173 multiple pathways via which the infusant can flow to displace the air and expel it from the catheter) as air can be trapped along the infusant return flow path rather than expelled (¶0172 air that is not removed from the pump catheter body can be trapped (such as in the infusant return line) and insuring the heart pump is in a position that allows air bubbles to float out of the device (¶0170 heart pump can be held vertically with the distal tip of the impeller upward so that air bubbles can float out).
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 device of Muller with the teachings of Battiato as Walters has described the potential problem of air being trapped downstream in the return flow path and as such one would have been motivated to provide the device of Battiato in the first connected device for the purpose of ensuring that the chambers of the first connected device are placed into an upright vertical position as Walters has taught that this placement allows air bubbles to float out of the device prior to inserting the heart pump into the patient (¶0170).
Muller in view of Battiato fail to disclose or suggest the displayed representation of the detected and predetermined orientations being visual representations displayed concurrently on the user interface.
However, Popa, in the same field of endeavor of catheter position detection, teaches a display 506 wherein a visual representation of a detected catheter orientation (arrow 526) is displayed concurrently with a visual representation of a predetermined orientation (¶0143 pre-defined orientation relative to one another, reference mark orientation 524) for the purpose of clearly displaying to the operator which direction to rotate the source catheter to attain alignment (¶0145).
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 device suggested by Muller in view of Battiato to have displayed a visual representation of the detected orientation concurrently with the reference orientations established in Fig. 13a of Battiato for the purpose of clearly displaying to the operator which direction to rotate the catheter in order to attain alignment of the device, as taught by Popa in ¶0145.
Regarding claim 10, Muller in view of Battiato and further in view of Popa and Walters suggest the system of claim 9. Battiato further suggests determining whether the detected orientation matches the predetermined orientation wherein air is releasable from the cavity (Col. 19 lines 49-67 175 receives signal from tilt sensor indicative of the angle relative to earth gravity, determines angle with respect to Earth gravity and determines how the device may function based on the region the angle is determined to be within. Regions 1, 2a and 2b are predetermined to be regions in which air is releasable, allows for removal of air in these regions and therefore determines whether the detected orientation matches on of these region orientations). Thus, it would be obvious to one of skill in the art to provide the above combination of elements and features, and one of skill would have been motivated to do so.
Regarding claim 11, Muller in view of Battiato and further in view of Popa and Walters suggest the system of claim 9. Battiato further suggests computing a difference of the detected orientation and the predetermined orientation to guide a user to change the orientation in order to approach the predetermined orientation (CPU computes detected orientation against predetermined orientation, if not in proper region of orientation the system will not allow the user to perform certain functions, this inability to perform functions guides user to change orientation in order to perform the function). Furthermore, Popa further teaches displaying the measured alignment angle through calculation of the alignment angle by a processor (¶0143). Thus, it would be obvious to one of skill in the art to provide the above combination of elements and features, and one of skill would have been motivated to do so as in order to display the alignment angle of the detected orientation to the predetermined orientation the control unit must first process the sensed orientation and calculate the alignment angle of the sensed orientation to the reference orientation in order to provide the concurrent representation.
Regarding claim 12, Muller in view of Battiato and further in view of Popa and Walters suggest the system of claim 9. Battiato and Popa further suggests the control unit being configured to display a first indicator indicating matching of the detected orientation with the predetermined orientation (controller of Battiato prevents purging of air from the system until positioned in Region 1, 2a, or 2b which displays the indicator of the system not allowing the function to the user) and a second indicator indicating a difference between the detected orientation and the predetermined orientation (display of the detected orientation concurrently with the predetermined orientation inherently indicates a difference between them to the user through their respective displayed orientation to one another). Thus, it would be obvious to one of skill in the art to provide the above combination of elements and features, and one of skill would have been motivated to do so.
Regarding claim 13, Muller in view of Battiato and further in view of Popa and Walters suggest the system of claim 9. Battiato further suggests the predetermined orientation being a conical range around a vertical axis defined by a predetermined angle (Regions 1, 2a, and 2b represent range of angles around a vertical axis that is representative of a conical shape around the vertical axis). Thus, it would be obvious to one of skill in the art to provide the above combination of elements and features, and one of skill would have been motivated to do so.
Regarding claim 14, Muller in view of Battiato and further in view of Popa and Walters suggest the system of claim 9. Battiato further suggests supplying the fluid comprises activating a fluid supply of the fluid when the detected orientation matches the predetermines orientation, and the fluid supply being deactivated when the detected orientation differs from the predetermines orientation (allows purging of air when in regions 1, 2a, or 2b and does not allow for purging of air when in regions 3 or 4 which do not correspond to regions 1, 2a, or 2b). Thus, it would be obvious to one of skill in the art to provide the above combination of elements and features, and one of skill would have been motivated to do so.
Regarding claim 16, Muller in view of Battiato and further in view of Popa and Walters suggest the system of claim 9. Battiato further suggests the orientation being detected by means of at least one sensor 158, wherein the at least one sensor includes an accelerometer (Col. 15 lines 20-31), wherein the at least one sensor is arranged in the device (158 arrange on circuit board 55 located inside housing of device).
Regarding claim 17, Muller in view of Battiato and further in view of Popa and Walters suggest the system of claim 1. Muller further discloses a pump unit 116a of an intravascular blood pump (Fig. 1B), the pump unit connected to the distal end 170A of the elongate tubular portion 174A and the pump unit including an impeller (¶0047 impeller with one or more blades) which is rotatable about an axis of rotation (¶0047 rotates to pump blood) to convey blood from a blood flow inlet to a blood flow outlet (¶0042 inlet in left ventricle pump to outlet of aorta) of the pump unit.
Regarding claim 18, Muller in view of Battiato and further in view of Popa and Walters suggest the system of claim 1. Muller further discloses the first connected device being a handle (see examiner note) portion (Fig. 2 with external housing attached to 11A and B ¶0059) of an intravascular blood pump (Fig. 1B).
Examiner notes that while Muller does not expressly disclose the elements 201 and 203 as a handle, however, the limitation of “handle” is considered functional language (describes the ability of the portion to be “handled” or grasped by a user). While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does (Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990)). Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, the device of Muller in view of Battiato and Popa discloses all the structure as claimed. As such, it is capable of performing the functions as claimed (i.e. it is capable of functioning as a handle).
Regarding claim 19, Muller in view of Battiato and further in view of Popa and Walters suggest the system of claim 1. Popa further suggests the visual representation of the detected orientation being displayed relative to the visual representation of the predetermined orientation to indicate a difference in orientation between the detected orientation and the predetermined orientation (Popa discloses the detected orientation alongside the reference mark for the purpose of defining the orientation relative to one another ¶0143). Thus, it would be obvious to one of skill in the art to provide the above combination of elements and features, and one of skill would have been motivated to do so.
Regarding claim 21, Muller in view of Battiato and further in view of Popa and Walters suggest the system of claim 1. Muller further discloses the first connected device comprising an inlet (position of seal 19 where fluid exits chamber 5 and enters chamber 4) and the system further comprising a purge line 6 connected to the inlet of the first connected device (connected to 5 which is connected to inlet as detailed in ¶0066 after initially cooling distal components some or all of the supplied fluid 35 can flow in a space disposed radially between the drive shaft and the catheter body 120A. The proximally-flowing fluid can flow along a flow pathway which removes heat from the motor assembly. As shown in Fig. 4A, the proximally-flowing fluid (or other cooling fluid) can flow into the rotor chamber of the flow diverter 3), the purge line configured to supply a purge fluid 35 to the at least one cavity through the inlet (¶0066 after initially cooling distal components some or all of the supplied fluid 35 can flow in a space disposed radially between the drive shaft and the catheter body 120A. The proximally-flowing fluid can flow along a flow pathway which removes heat from the motor assembly. As shown in Fig. 4A, the proximally-flowing fluid (or other cooling fluid) can flow into the rotor chamber of the flow diverter 3), wherein, in the predetermined orientation (vertical as taught by Walters and Battiato), the inlet is positioned vertically below the proximal end of the elongate tubular portion as measured in a direction of gravity (inlet being positioned at the proximal end of the elongate body 174A with the catheter body held vertically as taught by Walters would result in the inlet being below the proximal end of the elongate tubular portion as measured in the direction of gravity).
Claims 8 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Muller (U.S. Publication 2018/0021495) in view of Battiato (U.S. Patent No. 5,868,710) henceforth referred to as Battiato and Walters et al. (U.S. Publication 2012/0178985) and Popa et al. (U.S. Publication 2021/0244434) as rejected in claim 1, and further in view of Muller (U.S. Publication 2017/0028115).
Regarding claim 8, Muller in view of Battiato and further in view of Popa and Walters suggest the system of claim 1. Muller further discloses a handle portion (Fig. 2 with external housing attached to 11A and B ¶0059, see below examiners note), a pump unit 116A, and a drive unit 15 to provide an intravascular blood pump for percutaneous (¶0004, percutaneously) insertion into a patient's blood vessel (¶0057 clinician urging the guidewire through the patient’s vascular system until the distal end of the guidewire is positioned in the desired position…once the distal end of the guidewire is positioned in the heart, the clinician can maneuver the impeller assembly over the guidewire until the impeller assembly reaches the distal end of the guidewire in the heart, blood vessel), wherein the handle portion is the first connected device 3 and the pump unit 116A is a second connected device 116A, wherein the pump unit 116A is disposed at the distal end 170A of the elongate tubular portion of the catheter and comprises a cavity (cavity housing impeller blades) in fluid communication with the lumen of an elongate tubular portion (¶0049 fluid introduced into the priming apparatus through the elongate body into the priming apparatus and thus in fluid communication with the cavity), the pump unit including an impeller (¶0047 impeller with one or more blades) which is rotatable about an axis of rotation (¶0047 rotates to pump blood) to convey blood from a blood flow inlet to a blood flow outlet (¶0042 inlet in left ventricle pump to outlet of aorta) of the pump unit, wherein the pump unit is an expandable pump unit (¶0043 expandable) with the impeller being coupled to a drive shaft 16 which extends through the lumen of the elongate tubular portion of the catheter (¶0051 drive shaft extends through catheter body 120A, catheter body pass within elongate catheter body 174A), and wherein the drive unit 15 is disposed in the at least one cavity of the handle portion (Fig. 4A shows rotor positioned within cavity 4; ¶0059 rotor chamber 4 within which the rotor is disposed)), wherein the drive unit is coupled to the drive shaft so as to cause rotation of the impeller (¶0061 rotor causes the output shaft to rotate, which in turn causes the drive shaft and the impeller to rotate, drive shaft thus rotatably coupled to the rotor through the output shaft).
Examiner notes that while Muller does not expressly disclose the housing described in ¶0059, the external housing attached to 11A and B, as a handle, however, the limitation of “handle” is considered functional language (describes the ability of the portion to be “handled” or grasped by a user). While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does (Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990)). Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, the device of Muller in view of Battiato and Popa discloses all the structure as claimed. As such, it is capable of performing the functions as claimed (i.e. it is capable of functioning as a handle).
Muller does not expressly disclose the drive shaft being flexible, however, Muller (U.S. Publication 2017/0028115), in the same field of endeavor of intravascular blood pumps, teaches a drive shaft that is flexible (¶0095 flexible member such as drive shaft).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the drive shaft of Muller (U.S. Publication 2018/0021495) that performs the function of providing rotating force to an impeller of a blood pump for the flexible drive shaft of Muller (U.S. Publication 2017/0028115) since these elements perform the same function of providing rotating force to an impeller of a blood pump. Simply substituting one drive shaft means for another would yield the predictable result of allowing a(n) rotating force to be applied to an impeller of a blood pump. See MPEP 2143.
Furthermore, the drive shaft of Muller (U.S. Publication 2018/0021495) is intended to extend through elongate lumen 174a which is intended to be navigated through a patient’s blood vessel. This extension and intended navigation of the device through a patient’s blood vessel would have made it obvious to one of ordinary skill in the art to have modified the drive shaft of Muller (U.S. Publication 2018/0021495) to have been flexible so as to be capable of navigating through the patient’s blood vessel which would be known to not be perfectly straight in nature.
Regarding claim 20, Muller in view of Battiato and further in view of Popa and Walters suggest the system of claim 17. Muller further discloses a drive unit 15 and a drive shaft 16, the drive shaft coupled to the impeller (¶0061 rotor causes the output shaft to rotate, which in turn causes the drive shaft and the impeller to rotate, drive shaft thus rotatably coupled to the rotor through the output shaft), the drive shaft extending through the lumen of the elongate tubular portion 120a of the catheter (¶0051 drive shaft extends through catheter body 120A, catheter body pass within elongate catheter body 174A) wherein the drive unit is disposed in the at least one cavity of the first connected device (Fig. 4A shows disposition of the drive unit within cavity 4), and the drive shaft extends through the lumen of the elongate tubular portion of the catheter and into the at least one cavity of the first connected device (Fig. 4A shows extension of drive shaft).
Muller does not expressly disclose the drive shaft being flexible, however, Muller (U.S. Publication 2017/0028115), in the same field of endeavor of intravascular blood pumps, teaches a drive shaft that is flexible (¶0095 flexible member such as drive shaft).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the drive shaft of Muller (U.S. Publication 2018/0021495) that performs the function of providing rotating force to an impeller of a blood pump for the flexible drive shaft of Muller (U.S. Publication 2017/0028115) since these elements perform the same function of providing rotating force to an impeller of a blood pump. Simply substituting one drive shaft means for another would yield the predictable result of allowing a(n) rotating force to be applied to an impeller of a blood pump. See MPEP 2143.
Furthermore, the drive shaft of Muller (U.S. Publication 2018/0021495) is intended to extend through elongate lumen 174a which is intended to be navigated through a patient’s blood vessel. This extension and intended navigation of the device through a patient’s blood vessel would have made it obvious to one of ordinary skill in the art to have modified the drive shaft of Muller (U.S. Publication 2018/0021495) to have been flexible so as to be capable of navigating through the patient’s blood vessel which would be known to not be perfectly straight in nature.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Muller (U.S. Publication 2018/0021495) in view of Battiato (U.S. Patent No. 5,868,710) and Walters et al. (U.S. Publication 2012/0178985) and Popa et al. (U.S. Publication 2021/0244434) and further in view of Vecten et al. (U.S. Publication 2020/0316283).
Regarding claim 15, Muller in view of Battiato and further in view of Popa and Walters suggest the method of claim 9. Muller in view of Battiato and further in view of Popa and Walters do not expressly disclose or suggest measuring a volume of the supplied fluid.
However, Vecten, in the same field of endeavor of priming fluid lines to remove air, discloses measuring a volume of fluid supplied (¶0598 determines volume of solution based on measurement data of the supply container weight) through a line to expel air (¶0473, remove fluid initially present air), for the purpose of automating the priming of the fluid lines ¶0019 and stopping a fluid supplying pump when a determined volume of solution has been moved ¶0598.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the method step of measuring a volume of the supplied fluid as taught by Vecten to the method of Muller in view of Battiato and further in view of Popa and Walters for the purpose of automating the priming of the fluid lines ¶0019 and stopping a fluid supplying pump when a determined volume of solution has been moved ¶0598.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PETER DANIEL SMITH whose telephone number is (571)272-8564. The examiner can normally be reached Monday - Friday 7:30am-5:00pm.
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/PETER DANIEL SMITH/Examiner, Art Unit 3781
/CATHARINE L ANDERSON/Primary Examiner, Art Unit 3781
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