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 .
Claim Status
Claim amendments submitted on October 3rd, 2025 have been entered. Claims 1-20 are currently pending. Claim 20 has been newly added. Claims 1-4, 6, 8-12, and 16-18 have been amended. Claims 1-20 are thus under consideration.
Response to Arguments
Applicant's arguments filed March 5th, 2026 have been fully considered but they are not persuasive. Examiner agrees with applicant that the amended claim limitations has overcome the prior rejection of record as detailed in the Final Office Action mailed on December 8th, 2025. However, in light of a different interpretation of the device disclosed by Muller detailed in the rejection below, the amended claims 1 and 9 are seen to have been obvious to one of ordinary skill in the art and are thus rejected below. As such the applicant’s arguments have been considered but are moot because the new ground of rejections relies upon a different interpretation of the device of Muller necessitated by the change in scope of the claims through the amendment of the claim language and therefore does not rely upon the reference as applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
No further arguments directly drawn to any of the current rejection have been detailed by the applicant.
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 1-7, 9-14, and 16-19 are rejected under 35 U.S.C. 103 as being unpatentable over Muller (U.S. Publication 2017/0028115) in view of Battiato (U.S. Patent No. 5,868,710) henceforth referred to as Battiato and further in view of Popa et al. (U.S. Publication 2021/0244434).
Regarding claim 1, Muller discloses a system (Fig. 4), comprising a catheter (Fig. 4 element 100A), the catheter comprising an elongate tubular portion 120A; a first connected device (201 and 203), the elongate tubular portion 120A configured to be inserted into a patient's blood vessel (¶0053 into a peripheral blood vessel into the left ventricle; ¶0054 maneuver the impeller assembly over the guidewire until the impeller assembly reaches the distal end of the guidewire in the heart) and having a proximal end and a distal end (distal end 170A proximal end opposite distal end connecting at 201) and a lumen extending from the proximal end to the distal end (¶0012 lumen extending therebetween), the first connected device connected to the proximal end of the elongate tubular portion (¶0051 catheter body extends proximally and couples to a driven assembly 201) and having at least one cavity (¶0057 driven assembly can include a flow diverter 205…flow diverter can be configured with a plurality of internal cavities that are configured to route fluid to and from the patient during a medical procedure), wherein the at least one cavity is in fluid communication with the lumen of the elongate tubular portion (¶0057 infusate flows into the catheter body 120A, keeping blood from entering certain parts of the catheter assembly, ability of blood to enter suggests that it is in fluid communication with the blood circuit of the assembly as well, ¶0057 route fluid to patient suggests that it is in fluid communication with patient and thus in fluid communication with patient through catheter body 120A).
Muller further discloses expelling air from the impeller assembly through the use of an infusate (¶0048 introducing fluid into the sealed priming apparatus to expel air…fluid can be introduced distally through the elongate body 174A, ¶0050 infuse the system), 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 (¶0047), as well as infusate being delivered through internal cavities of the driven assembly, i.e. first connected device (¶0057 infusate directed into the flow diverted from a source of infusate).
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 for detecting an orientation of at least one of the elongate tubular portion and the at least one 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 rout fluid to and from 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 (¶0057 keeping blood from entering certain parts of the catheter assembly, as well as configured to route fluid to and from the patient during a medical procedure suggest fluid communication with patient) 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.
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 Popa 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 Popa 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 Popa 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 Popa 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 6, Muller in view of Battiato and Popa suggest the system of claim 1. Battiato further suggests the sensor being arrange in the device and configured to detect an orientation of the device (158 arrange on circuit board 55).
Muller in view of Battiato and Popa do not expressly disclose or suggest the sensor being arranged in the first connected device. However, it would have been obvious to one of ordinary skill in the art to have positioned it in the connected device as this portion of the device comprises internal cavities in which air could be potentially trapped prior to priming these cavities with infusate. As such one would have been motivated to include the sensor in the connected device disclosed by Muller for the purpose of ensuring that all air was purged from these cavities prior to connection of the device with the patient.
Regarding claim 7, Muller in view of Battiato and Popa 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 of preparing a catheter for use in a patient (¶0047 method of expelling air through priming), comprising an elongate tubular portion 120A; a first connected device (201 and 203), the elongate tubular portion 120A configured to be inserted into a patient's blood vessel (¶0053 into a peripheral blood vessel into the left ventricle; ¶0054 maneuver the impeller assembly over the guidewire until the impeller assembly reaches the distal end of the guidewire in the heart) and having a proximal end and a distal end (distal end 170A proximal end opposite distal end connecting at 201) and a lumen extending from the proximal end to the distal end (¶0012 lumen extending therebetween), the first connected device connected to the proximal end of the elongate tubular portion (¶0051 catheter body extends proximally and couples to a driven assembly 201) and having at least one cavity (¶0057 driven assembly can include a flow diverter 205…flow diverter can be configured with a plurality of internal cavities that are configured to route fluid to and from the patient during a medical procedure), wherein the at least one cavity is in fluid communication with the lumen of the elongate tubular portion (¶0057 infusate flows into the catheter body 120A, keeping blood from entering certain parts of the catheter assembly, ability of blood to enter suggests that it is in fluid communication with the blood circuit of the assembly as well, ¶0057 route fluid to patient suggests that it is in fluid communication with patient and thus in fluid communication with patient through catheter body 120A).
the method comprising the steps of: supplying a fluid into the at least one cavity of the first connected device and the lumen of the elongate tubular portion to purge the at least one cavity and the lumen (¶0057 flow diverter 205 configured with a plurality of internal cavities, passages, and cahnnels that are configured to rout fluid to and from the patient..infusate directed into flow diverter. Infusate flows into the catheter body to keep blood from entering certain parts of the catheter assembly).
Muller further discloses expelling air from the impeller assembly through the use of an infusate (¶0048 introducing fluid into the sealed priming apparatus to expel air…fluid can be introduced distally through the elongate body 174A, ¶0050 infuse the system), 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 (¶0047), as well as infusate being delivered through internal cavities of the driven assembly, i.e. first connected device (¶0057 infusate directed into the flow diverted from a source of infusate).
Muller does not expressly disclose 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.
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.
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 Popa 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 Popa 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 Popa 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 Popa 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 Popa 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 Popa 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),
Muller in view of Battiato and Popa do not expressly disclose or suggest the sensor being arranged in the first connected device of the device.
However, it would have been obvious to one of ordinary skill in the art to have positioned it in the connected device as this portion of the device comprises internal cavities in which air could be potentially trapped prior to priming these cavities with infusate. As such one would have been motivated to include the sensor in the connected device disclosed by Muller for the purpose of ensuring that all air was purged from these cavities prior to connection of the device with the patient.
Regarding claim 17, Muller in view of Battiato and Popa suggest the system of claim 1. Muller further discloses a pump unit 1400 of an intravascular blood pump (Fig. 4), the pump unit connected to the distal end 170A of the elongate tubular portion 174A and the pump unit including an impeller (¶0046 impeller with one or more blades) which is rotatable about an axis of rotation (¶0046 rotates to pump blood) to convey blood from a blood flow inlet to a blood flow outlet (see illustrative diagram of Fig. 3 below) of the pump unit.
Regarding claim 18, Muller in view of Battiato and Popa suggest the system of claim 1. Muller further discloses the first connected device being a handle (see examiner note) portion 201, 203 of an intravascular blood pump (Fig. 4).
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 Popa 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.
Claims 8 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Muller (U.S. Publication 2017/0028115) in view of Battiato (U.S. Patent No. 5,868,710) henceforth referred to as Battiato and Popa et al. (U.S. Publication 2021/0244434) as rejected in claim 1, and further in view of Aboul-Hosn et al. (U.S. Publication 2015/0073202) further referred to as Aboul.
Regarding claim 8, Muller in view of Battiato and Popa suggest the system of claim 1. Muller further discloses a handle portion (201 and 203, see below examiners note), a pump unit 116A, and a drive unit (201, 203, and 208) to provide an intravascular blood pump for percutaneous (¶0003, percutaneously) insertion into a patient's blood vessel(¶0053 through a needle into a peripheral blood vessel), wherein the handle portion (201 and 203) is the first connected device and the pump unit 116A is a second connected device 116A and 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 (¶0048 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 (¶0046 impeller with one or more blades) which is rotatable about an axis of rotation (¶0046 rotates to pump blood) to convey blood from a blood flow inlet to a blood flow outlet (see illustrative diagram of Fig. 3 below) of the pump unit, wherein the pump unit is an expandable pump unit (¶0050 expandable portion) with the impeller being coupled to a flexible (¶0095 flexible member such as drive shaft) drive shaft 208 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 (201, 203, and 208) is disposed in the at least one cavity (drive shaft of the handle portion (201 and 203) which is another one of the at least one connected device and which is coupled to the flexible drive shaft so as to cause rotation of the impeller (coupled to 201 to drive 208 to rotate the impeller).
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).
Muller does not expressly disclose the how the drive unit is connected internally to the infusate fluid simply stating that the fluid flows into the catheter body to cool moving parts and keeping blood from entering certain parts of the catheter assembly and that the infusate is diverted distally by flow channels in the flow diverter ¶0057, and as such does not expressly disclose the pump unit comprising a cavity in fluid communication with the lumen of the elongate tubular portion or the drive unit being disposed in the at least one cavity of the handle portion.
However, Aboul, in the same field of endeavor of impeller driven blood pumps to be inserted into a patient, teaches a catheter system (Fig. 13) comprising a handle portion 96 and a pump unit 12 comprising a cavity (cavity formed by shroud 36) in fluid communication (¶0068 purge fluid flows distally around the capble adapter, through the ball bearing assemblies, and onward past the radial seal. This egress of purge fluid past the radial seal can be controlled to effectively thwart the ingress of blood past the radial seal) with a lumen 74 of an elongate tubular portion 32 that is in fluid communication with a cavity 98 of the handle portion 96 wherein the drive unit is disposed in the at least one cavity (¶0070 drive shaft 62 coupled at 86 within chamber 98).
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 infusate pathway of Muller that performs the function of preventing blood from entering certain parts of the catheter assembly (¶0057) for the infusate pathway of Aboul since these elements perform the same function of providing infusate to catheter assembly to prevent blood from entering certain parts (¶0068 of Aboul thwart the ingress of blood past the radial seal). Simply substituting one infusate pathway means for another would yield the predictable result of allowing a(n) driven assembly to supply infusate to the catheter parts. See MPEP 2143.
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 Muller to have had the drive unit disposed in the cavity and the flexible drive shaft extending through the lumen of the elongate tubular portion of the catheter and into the at least one cavity for the purpose of coupling the flexible drive shaft to the motor assembly as taught by Aboul which would allow for the drive shaft and subsequent parts to be exposed to the infusate for cooling as suggested by Muller ¶0057.
Regarding claim 20, Muller in view of Battiato and Popa suggest the system of claim 17. Muller further discloses a drive unit and a flexible drive shaft, the flexible drive shaft coupled to the impeller, the flexible drive shaft extending through the lumen of the elongate tubular portion 120a of the catheter.
Muller does not expressly disclose the drive unit being disposed in the at least one cavity of the first connected device, or the flexible drive shaft extending through the lumen of the elongate tubular portion of the catheter and into the at least one cavity of the first connected device.
However, Aboul, in the same field of endeavor of impeller driven blood pumps to be inserted into a patient, teaches a catheter system (Fig. 13) comprising a cavity 98 comprising a drive unit (86 and 62) disposed in the cavity and a flexible drive shaft 62 extending through a lumen 74 of an elongate tubular portion 32 of the catheter (Fig. 13) and into the at least one cavity for the purpose of coupling the flexible drive shaft to a motor assembly (¶0070).
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 Muller to have had the drive unit disposed in the cavity and the flexible drive shaft extending through the lumen of the elongate tubular portion of the catheter and into the at least one cavity for the purpose of coupling the flexible drive shaft to the motor assembly as taught by Aboul which would allow for the drive shaft and subsequent parts to be exposed to the infusate for cooling as suggested by Muller ¶0057.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Muller (U.S. Publication 2017/0028115) in view of Battiato (U.S. Patent No. 5,868,710) 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 Popa suggest the method of claim 9. Muller in view of Battiato and Popa 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 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
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PETER DANIEL SMITH whose telephone number is (571)272-8564. The examiner can normally be reached Monday - Friday 7:30am-5:00pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at 571-272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PETER DANIEL SMITH/Examiner, Art Unit 3781
/CATHARINE L ANDERSON/Primary Examiner, Art Unit 3781
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