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 was filed in this application after a decision by the Patent Trial and Appeal Board, but before the filing of a Notice of Appeal to the Court of Appeals for the Federal Circuit or the commencement of a civil action. 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examination under 37 CFR 1.114 and the fee set forth in 37 CFR 1.17(e) has been timely paid, the appeal has been withdrawn pursuant to 37 CFR 1.114 and prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant’s submission filed on February 17th, 2026 has been entered.
Claim Status
No claims have been amended by the response submitted on February 17th, 2026. Claims 1-13, 15, 25-31, and 33-34 remain pending and are currently under consideration. Claims 16-24 and 35-36 remain cancelled. Claims 14 and 32 have been newly cancelled. Claims 1 and 25 have been amended.
Response to Arguments
Applicant's arguments filed February 17th, 2026 have been fully considered but they are not persuasive.
Regarding applicant’s argument that the detection system of Rothenberg would not be accurate enough to work as intended to determine the location of the distal tip of the pressurized conduit based on the statement of Rothenberg ¶0054, the examiner does not find this argument persuasive as the statement of Rothenbergs ¶0013 ¶0054 is not stating a sensitivity of the measurement as reasoned by the applicant but is rather stating that when the tip comes within 1cm to 2cm area of proximal of the entrance it will begin to detect the deflection value is known to increase which is simply just stating a biologically measured response to being in the position of 1cm to 2cm proximal to the sin-atrial node and is not a statement of sensitivity of detection in itself which can be seen in the disclosure of ¶0055 which states once the first anode/cathode pair enters the right atrium the deflection value will double. This analysis of deflection value based on the position of a first pair compared to the second pair is enough for one of ordinary skill in the art to be able to utilize deflection values between two anode/cathode pairs in order to determine the positioning of the pressurized fluid catheter in relation to an outer catheter due to the fact that it would have been obvious based on this disclosure that as the inner catheter approached the vasculature the deflection value of the P wave would inherently change and increase and one of ordinary skill in the art would be able to determine what value of deflection correlates to the proper positioning of the catheter. As such this argument is not found to be persuasive.
Regarding applicant’s argument that the systems of Rothenberg requires a plurality of electrodes in order to determine a proximity to the sino-atrial node, and as such is only able to determine a location of the catheter tip once the specific pattern has been detected, the current claim limitations do not require only a single electrode to be used, but simply require the tip tracking system to use the differences between signals received at an electrode to determine the location. The fact that additional data is utilized by Rothenberg is inconsequential as there is currently no claim limitation that requires only a single electrodes data to be utilized.
Arguments pertaining to Elberse are herein considered moot as the Elberse reference is no longer relied upon in the current rejection.
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, 3, 4, 25, and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Clement (U.S. Publication No. 2014/0102445) in view of Kirn (U.S. Publication No. 2013/0190701), Caimi et al. (U.S. Patent No. 5,730,806), and Rothenberg (U.S. Publication 2008/0097232).
Regarding claim 1, Clement discloses an embolectomy system (Figure 1A and 1B) for restoring patency (Paragraph [0004]) to an indwelling catheter (Paragraph [0006]; Figure 1B element 9) having an occlusion (Paragraph [0006]; 14) disposed therein, the indwelling catheter (Paragraph [0006]; 9) including a catheter lumen (see illustrative diagram of Figure 1B below) extending from a proximal end (see illustrative diagram of Figure 1B) of the indwelling catheter to a distal end (see illustrative diagram of Figure 1B below) of the indwelling catheter (Paragraph [0006]; 9), the embolectomy system (Figure 1A and 1B) comprising: a pressurized (Paragraph [0065]) fluid conduit (10) including a conduit body (see illustrative diagram of Figure 1B below) and a conduit lumen (12), the conduit body (see illustrative diagram of Figure 1B below) having an outer diameter (see illustrative diagram of Figure 1B below) less than an inner diameter (see illustrative diagram of Figure 1B below) of the catheter lumen (see illustrative diagram of Figure 1B below) to enable insertion and disposition of the pressurized (Paragraph [0065]) fluid conduit (10) in the catheter lumen; a positive pressure source (58) in fluid communication (Paragraph [0066]) with a proximal end of the conduit lumen (12), the positive pressure source (58) providing a pressurized (Paragraph [0065]) fluid (Paragraph [0066]) , the conduit lumen (12) directing the pressurized (Paragraph [0065]) fluid (Paragraph [0066]) into the occlusion (14) in the catheter lumen (see illustrative diagram of Figure 1B below); and a negative pressure source (Paragraph [0047]) in fluid communication (Paragraph [0054]) with the catheter lumen to aspirate (15; Paragraph [0054]) the occlusion (14) from the catheter lumen (see illustrative diagram of Figure 1B below).
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Illustrative diagram of Figure 1B of Clement (U.S. Publication No. 2014/0102445).
Clement does not expressly disclose the indwelling catheter being an intravascular indwelling catheter, the distal tip of the catheter lumen disposed intravascularly, the negative pressure source being in fluid communication with the proximal end of the catheter lumen disposed external to a vasculature, to aspirate the occlusion from the catheter lumen over at least a portion of an outer surface of the conduit body, the conduit body including a nozzle disposed at a distal-most end thereof, the nozzle defining a nozzle lumen having a converging portion disposed proximally and a diverging portion disposed distally.
However, regarding the negative pressure source being located in fluid communication with the proximal end of the catheter lumen, Kirn, in the same field of endeavor of catheter patency restoration, teaches a system (10) for restoring patency (Paragraph [0025]) to an indwelling (Paragraph [0003] gives examples of tubes for which system can be used) catheter (T) comprising a negative pressure source (Paragraph [0011], suction line) in fluid communication (Paragraph [0007] fitting coupled to medical line and in communication through element 50) with the proximal end (see illustrative diagram of Figure 4 below) of a catheter (T) lumen to aspirate an occlusion (Figure 3 element C) from the catheter (T) lumen over (Figure 3 element H shows flow around element 32) at least a portion of an outer surface of a conduit body (32) for the purpose of assisting in the exhaustion of the fluid and the fragments (Paragraph [0008]).
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Illustrative diagram of Figure 4 of Kirn (U.S. Publication 2013/0190701).
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 negative pressure source of Clement that performs the function of removing fluid and occlusion fragments from a catheter for the negative pressure source of Kirn since these elements perform the same function of removing fluid and occlusion fragments from a catheter. Simply substituting one fluid and occlusion removal means for another would yield the predictable result of allowing an occlusion removing device to remove fluid and occlusion fragments from a catheter. See MPEP 2143.
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Regarding the conduit body including a nozzle disposed at a distal-most end thereof, the nozzle defining a nozzle lumen having a converging portion disposed proximally and a diverging portion disposed distally, Caimi, in the same field of endeavor of pressurized fluid delivery, discloses a conduit body 42 including a nozzle 18 disposed at a distal-most end thereof, the nozzle 18 defining a nozzle lumen 34 having a converging portion (see illustrative diagram of Figure 3 below) disposed proximally (see below illustrative diagram of Figure 3 below) and a diverging portion (see illustrative diagram of Figure 3 below) disposed distally (see below illustrative diagram of Figure 3 below) for the purpose of causing acceleration of the liquid as it passes through the nozzle passages (Col. 3 lines 1-19).
Illustrative diagram of Figure 3 of Caimi (U.S. Patent No. 5,730,806).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the conduit body disclosed by Clement to have included the nozzle as taught by Caimi for the purpose of causing acceleration of the liquid as it passes through the nozzle passages (Col. 3 lines 1-19 of Caimi).
Regarding the catheter being an intravascular indwelling catheter, the distal tip of the catheter lumen being disposed intravascularly, and the proximal end of the catheter lumen being disposed external to a vasculature, the limitations of “intravascular”, “disposed intravascularly”, “disposed external to a vasculature” are considered functional language (terminology indicates the placement of the catheter within a patient’s vascular system). 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 Clement in view of Kirn and Caimi suggest all the structure as claimed, and is further indicated as an indwelling catheter dictating the placement of the device within a patient. As such, it is capable of performing the functions as claimed (i.e., it is capable of being an intravascular indwelling catheter with one end placed into the vasculature of a patient).
Clement in view of Kirn and Caimi do not expressly disclose an electrode coupled with a distal tip of the pressurized fluid conduit and configured for detecting one or more ECG signals, and a tip tracking system for receiving a first ECG signal and a second ECG signal from the electrode and determining, based on differences in overall amplitude between the first ECG signal and the second ECG signal, if the distal tip of the pressurized fluid conduit is proximate a distal tip of the indwelling catheter. However, Rothenberg, in the same field of endeavor of catheters intended to be inserted, teaches including an electrode (150, 152, 154, or 156) coupled with a distal tip (112) of a fluid conduit (100) and configured for detecting (Paragraph [0046] ECG waveforms detected) one or more ECG signals (Paragraph [0046] ECG trace), and a tip tracking system (200; Paragraph [0065]) for receiving (Paragraph [0065]) a first ECG signal (signal of first position “P1” and a second ECG signal (signal of second position P2) from the electrode (¶0012 ECG trace made by electrode) and determining based on differences in overall amplitude (Fig.1A and 1B show the difference in amplitude of P-wave produced at different locations) between the first ECG signal and the second ECG signal (difference in amplitude of P-wave detected determine relative position of distal tip as amplitude is seen to increase as it gets closer to SA node () if the distal tip (112) of the fluid conduit is proximate a desired location (Paragraph [0034]) for the purpose of properly locating the tip and exposing patients to fewer risks (Paragraph [0034]) such as perforation of blood vessels (Paragraph [0005]).
Furthermore, Clement teaches that the pressurize (Paragraph [0065]) fluid (Paragraph [0066]) conduit should not be over-inserted (Paragraph [0008]) beyond a distal tip (Paragraph [0008] of the indwelling catheter (Paragraph [0006]; Figure 1B element 9).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the distal tips of the catheter lumen and the pressurized fluid conduits of Clement in view of Kirn and Caimi to have included an electrode coupled with the distal tip of the fluid conduits and a tip tracking system that receives a first ECG signal and a second ECG signal from the electrodes and determines based on differences in overall amplitude between the first ECG signal and the second ECG signal if the distal tip of the fluid conduit is proximate a desired location as taught by Rothenberg wherein the desired location is the distal tip of indwelling catheter for the pressurized fluid conduit, as Clement reasons that the tip of the obstruction clearing device should not be over inserted into the catheter (Paragraph [0008]) and therefore would benefit from determining its proximity to the distal tip of the catheter lumen. As the tip tracking system of Rothenberg determines changes in catheter positioning based on changes in the amplitude of an ECG trace, it would have been obvious for the pressurized fluid conduit’s location to also be tracked utilizing differences in amplitude of an ECG trace which would inherently increase as the tip proceeded in a proximate direction toward the catheter lumen distal tip.
Regarding claim 3, Clement in view of Kirn and Caimi suggest the embolectomy system according to claim 1. Clement in view of Kirn and Caimi further suggest the converging portion extending from a first diameter (start of convergence diameter) at a proximal end thereof to a second diameter 36 at a distal end thereof, the second diameter 36 being less than the first diameter, and the diverging portion extending from the second diameter 36 at a proximal end thereof to the first diameter (end of divergence equivalent to start of convergence) at a distal end thereof (See illustrative diagram of Figure 3 of Caimi above), such that it would have been obvious to one of skill before the effective filing date to modify the embolectomy system of Clement according to Kirn and Caimi, and one of skill would have been motivated to do so, in order to provide a smaller second diameter at the distal end of the converging portion that pressure is maintained to sufficient levels for the system to work properly.
Regarding claim 4, Clement in view of Kirn and Caimi suggest the embolectomy system according to claim 1. Clement further discloses the pressurized (Paragraph [0065] of Clement) fluid (Paragraph [0066] of Clement) including saline (Paragraph [0066] of Clement).
Regarding claim 25, Clement discloses an embolectomy system (Figure 1A and 1B) for removing (Paragraph [0006]) an occlusion (14) from an indwelling catheter (Paragraph [0006]; Figure 1B element 9), comprising: a pressurized (Paragraph [0065]) fluid conduit (10) including a conduit lumen (12), a distal tip (112) of the pressurized fluid conduit disposed within a lumen (see illustrative diagram of Figure 1B of Clement above) of the indwelling catheter and a second (11) conduit lumen; a positive pressure source (58) in fluid communication (Paragraph [0066]; element 16) with the first (12) conduit lumen, the positive pressure source (58) providing a pressurized (Paragraph [0065]) fluid (Paragraph [0066]) for ablating (Paragraph [0058]) the occlusion (14); and a negative pressure source (Paragraph [0047]) in fluid communication (Paragraph [0054]; element 15) with the second conduit lumen (11), the negative pressure source (Paragraph [0047]) providing (Paragraph [0047]) a negative pressure for aspirating (element 15; Paragraph [0047]) the occlusion (14) from the indwelling catheter (Paragraph [0006]; Figure 1B element 9).
Clement does not expressly disclose the indwelling catheter being disposed intravascularly, a distal tip of the indwelling catheter disposed intravascularly, the negative pressure source being in fluid communication with a proximal end of the lumen of the indwelling catheter or the first conduit lumen including a nozzle defining a nozzle lumen and disposed at a distal-most end thereof, the nozzle lumen having a converging portion disposed proximally and a diverging portion disposed distally.
However, regarding the negative pressure source being located in fluid communication with the proximal end of the catheter lumen, Kirn, in the same field of endeavor of catheter patency restoration, teaches a system (10) for restoring patency (Paragraph [0025]) to an indwelling (Paragraph [0003] gives examples of tubes for which system can be used) catheter (T) comprising a negative pressure source (Paragraph [0011], suction line) in fluid communication (Paragraph [0007] fitting coupled to medical line and in communication through element 50) with the proximal end (see illustrative diagram of Figure 4 below) of a catheter (T) lumen to aspirate an occlusion (Figure 3 element C) from the catheter (T) lumen over (Figure 3 element H shows flow around element 32) at least a portion of an outer surface of a conduit body (32) for the purpose of assisting in the exhaustion of the fluid and the fragments (Paragraph [0008]).
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Illustrative diagram of Figure 4 of Kirn (U.S. Publication 2013/0190701).
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 negative pressure source of Clement that performs the function of removing fluid and occlusion fragments from a catheter for the negative pressure source of Kirn since these elements perform the same function of removing fluid and occlusion fragments from a catheter. Simply substituting one fluid and occlusion removal means for another would yield the predictable result of allowing an occlusion removing device to remove fluid and occlusion fragments from a catheter. See MPEP 2143.
Regarding the first conduit lumen including a nozzle, Caimi, in the same field of endeavor of pressurized fluid delivery, discloses a conduit body 42 including a nozzle 18 disposed at a distal-most end thereof, the nozzle 18 defining a nozzle lumen 34 having a converging portion (see illustrative diagram of Figure 3 above) disposed proximally (see illustrative diagram of Figure 3 above) and a diverging portion (see illustrative diagram of Figure 3 above) disposed distally (see below illustrative diagram of Figure 3 above) for the purpose of causing acceleration of the liquid as it passes through the nozzle passages (Col. 3 lines 1-19).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the conduit body disclosed by Clement to have included the nozzle as taught by Caimi for the purpose of causing acceleration of the liquid as it passes through the nozzle passages (Col. 3 lines 1-19 of Caimi).
Regarding the catheter being an intravascular indwelling catheter, the distal tip of the catheter lumen being disposed intravascularly, and the proximal end of the catheter lumen being disposed external to a vasculature, the limitations of “intravascular”, “disposed intravascularly”, “disposed external to a vasculature” are considered functional language (terminology indicates the placement of the catheter within a patient’s vascular system). 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 Clement in view of Kirn and Caimi suggest all the structure as claimed, and is further indicated as an indwelling catheter dictating the placement of the device within a patient. As such, it is capable of performing the functions as claimed (i.e., it is capable of being an intravascular indwelling catheter with one end placed into the vasculature of a patient).
Clement in view of Kirn and Caimi do not expressly disclose an electrode coupled with a distal tip of the pressurized fluid conduit and configured for detecting one or more ECG signals, and a tip tracking system for receiving a first ECG signal and a second ECG signal from the electrode and determining, based on differences in overall amplitude between the first ECG signal and the second ECG signal, if the distal tip of the pressurized fluid conduit is proximate a distal tip of the indwelling catheter. However, Rothenberg, in the same field of endeavor of catheters intended to be inserted, teaches including an electrode (150, 152, 154, or 156) coupled with a distal tip (112) of a fluid conduit (100) and configured for detecting (Paragraph [0046] ECG waveforms detected) one or more ECG signals (Paragraph [0046] ECG trace), and a tip tracking system (200; Paragraph [0065]) for receiving (Paragraph [0065]) a first ECG signal (signal of first position “P1” and a second ECG signal (signal of second position P2) from the electrode (¶0012 ECG trace made by electrode) and determining based on differences in overall amplitude (Fig.1A and 1B show the difference in amplitude of P-wave produced at different locations) between the first ECG signal and the second ECG signal (difference in amplitude of P-wave detected determine relative position of distal tip as amplitude is seen to increase as it gets closer to SA node () if the distal tip (112) of the fluid conduit is proximate a desired location (Paragraph [0034]) for the purpose of properly locating the tip and exposing patients to fewer risks (Paragraph [0034]) such as perforation of blood vessels (Paragraph [0005]).
Furthermore, Clement teaches that the pressurize (Paragraph [0065]) fluid (Paragraph [0066]) conduit should not be over-inserted (Paragraph [0008]) beyond a distal tip (Paragraph [0008] of the indwelling catheter (Paragraph [0006]; Figure 1B element 9).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the distal tips of the catheter lumen and the pressurized fluid conduits of Clement in view of Kirn and Caimi to have included an electrode coupled with the distal tip of the fluid conduits and a tip tracking system that receives a first ECG signal and a second ECG signal from the electrodes and determines based on differences in overall amplitude between the first ECG signal and the second ECG signal if the distal tip of the fluid conduit is proximate a desired location as taught by Rothenberg wherein the desired location is the distal tip of indwelling catheter for the pressurized fluid conduit, as Clement reasons that the tip of the obstruction clearing device should not be over inserted into the catheter (Paragraph [0008]) and therefore would benefit from determining its proximity to the distal tip of the catheter lumen. As the tip tracking system of Rothenberg determines changes in catheter positioning based on changes in the amplitude of an ECG trace, it would have been obvious for the pressurized fluid conduit’s location to also be tracked utilizing differences in amplitude of an ECG trace which would inherently increase as the tip proceeded in a proximate direction toward the catheter lumen distal tip.
Regarding claim 27, Clement in view of Kirn, Rothenberg, and Caimi suggest the embolectomy system according to claim 1. Clement in view of Kirn, Rothenberg, and Caimi further suggest the converging portion extending from a first diameter (start of convergence diameter) at a proximal end thereof to a second diameter 36 at a distal end thereof, the second diameter 36 being less than the first diameter, and the diverging portion extending from the second diameter 36 at a proximal end thereof to the first diameter (end of divergence equivalent to start of convergence) at a distal end thereof (See illustrative diagram of Figure 3 of Caimi above).
Claims 2 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Clement (U.S. Publication No. 2014/0102445) in view of Kirn (U.S. Publication No. 2013/0190701), Caimi et al. (U.S. Patent No. 5,730,806), and Rothenburg (U.S. Publication 2008/0097232) and further in view of Neracher (U.S. Patent No. 5,135,482).
Regarding claim 2, Clement in view of Kirn, Caimi, and Rothenburg suggest the embolectomy system according to claim 1. Clement in view of Kirn and Caimi further disclose the embolectomy system (Figure 1A and 1B of Clement) wherein the conduit lumen (12 of Clement) being in fluid communication with an opening (see illustrative diagram of Figure 1B above of Clement) disposed at a distal (Paragraph [0022] of Clement) end of the conduit body (see illustrative diagram of Figure 1B above of Clement) and the pressurized (Paragraph [0065] of Clement) fluid (Paragraph [0066] of Clement) exiting (16 of Clement) the opening (see illustrative diagram of Figure 1B above of Clement), but does not expressly disclose the pressurized (Paragraph [0065] of Clement) fluid (Paragraph [0066] of Clement) exiting the nozzle at an angle relative to a longitudinal axis of the conduit lumen.
However, Neracher, in the same field of endeavor of eliminating obstructions from tube structures, teaches an embolectomy system (Col. 1 lines 10-20) wherein a pressurized (Col. 1 lines 10-20) fluid exiting a nozzle (Figure 9) at an angle (β) relative to a longitudinal axis (see illustrative diagram of Figure 9 below) of the conduit lumen (see illustrative diagram of Figure 9 below) for the purpose of directing the stream toward the deposit to be eliminated (Col. 1 lines 10-20) and improving selectivity between the vessel wall and the deposit through direction of the liquid jet (Col. 1 lines 33-35).
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Illustrative Diagram of Figure 9 of Neracher (U.S. Patent No. 5,135,482)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the opening as disclosed by Clement with the nozzle that provides an adjusted opening as taught by Neracher for the purpose of directing the stream toward the deposit to be eliminated (Col. 1 lines 10-20) and improving selectivity between the vessel wall and the deposit through direction of the liquid jet (Col. 1 lines 33-35).
Regarding claim 26, Clement in view of Kirn, Caimi, and Rothenburg suggest the embolectomy system according to claim 25. Clement in view of Kirn, Caimi, and Rothenburg suggest the embolectomy system according to claim 25 as rejected above, wherein the first (12 of Clement) conduit lumen includes an opening (see illustrative diagram of Figure 1B above of Clement) at the distal (Paragraph [0022] of Clement) end that directs (16 of Clement) the pressurized (Paragraph [0065] of Clement) fluid (Paragraph [0066] of Clement), but does not expressly disclose the pressurized fluid being directed at an angle relative to a longitudinal axis of the first conduit lumen by the nozzle.
However, Neracher, in the same field of endeavor of eliminating obstructions from tube structures, teaches an embolectomy system (Col. 1 lines 10-20) wherein a nozzle (Figure 9) directs a pressurized (Col. 1 lines 10-20) fluid at an angle (β) relative to a longitudinal axis (see above diagram of Figure 9) of a conduit lumen (see above diagram of Figure 9) for the purpose of directing the stream toward the deposit to be eliminated (Col. 1 lines 10-20) and improving selectivity between the vessel wall and the deposit through direction of the liquid jet (Col. 1 lines 33-35).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the opening as disclosed by Clement with the opening as taught by Neracher the purpose of directing the stream toward the deposit to be eliminated (Col. 1 lines 10-20) and improving selectivity between the vessel wall and the deposit through direction of the liquid jet (Col. 1 lines 33-35).
Claims 5, 6, 7, 11, 12, 28, and 34 are rejected under 35 U.S.C. 103 as being unpatentable over Clement (U.S. Publication No. 2014/0102445) in view of Kirn (U.S. Publication No. 2013/0190701), Caimi (U.S. Patent No. 5,730,806) and Rothenberg (U.S. Publication 2008/0097232), and further in view of Ofek et al. (U.S. Publication No. 2017/0354777), henceforth referred to as Ofek.
Regarding claim 5, Clement in view of Kirn, Caimi, and Rothenburg suggest the embolectomy system according to claim 1. Clement in view of Kirn, Caimi, and Rothenburg do not expressly disclose or suggest the positive pressure source providing the pressurized fluid of between 0.1 psi to 400 psi. However, Ofek, in the same field of endeavor of removing occlusions in catheters, teaches a positive pressure source (38) providing a pressurized fluid (Paragraph [0022]) between 0.1 psi to 400 psi (Paragraph [0039]) for the purpose of controlling the pressure of impulses delivered to the catheter tube depending on factors including catheter length, catheter lumen size, burst strength, impulse duration, rest period duration, and other catheter configurations (Paragraph [0039]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the pressure of Clement as modified by Kirn and Caimi, from between 0.1 psi to 400 psi as applicant appears to have placed no criticality on the claimed range (¶[0005] “The positive pressure source provides the pressurized fluid between 0.1 psi to 400 psi”) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). In the instant case, Clement would not operate differently with the claimed range. Further, applicant places no criticality on the ranged claimed, indicating simply that the pressure is between 0.1 psi to 400 psi (¶[0005] “The positive pressure source provides the pressurized fluid between 0.1 psi to 400 psi”)
Furthermore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the positive pressure source of Clement to provide the pressurized fluid of between 0.1 psi to 400 psi for the purpose of controlling the pressure of impulses delivered to the catheter tube depending on factors including catheter length, catheter lumen size, burst strength, impulse duration, rest period duration, and other catheter configuration (Paragraph [0039]).
Regarding claim 6, Clement in view of Kirn, Caimi, and Rothenburg suggest the embolectomy system according to claim 1. Clement in view of Kirn, Caimi, and Rothenburg do not expressly disclose or suggest the positive pressure source providing the pressurized fluid of between 110 psi to 130 psi. However, Ofek, in the same field of endeavor of removing occlusions in catheters, teaches the positive pressure source (38) providing the pressurized fluid (Paragraph [0022]) between 110 psi to 130 psi (Paragraph [0039]) for the purpose of controlling the pressure of impulses delivered to the catheter tube depending on factors including catheter length, catheter lumen size, burst strength, impulse duration, rest period duration, and other catheter configurations (Paragraph [0039]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the pressure of Clement as modified by Kirn and Caimi, from between 110 psi to 130 psi as applicant appears to have placed no criticality on the claimed range (¶[0005] “The positive pressure source provides the pressurized fluid between 110 psi to 130 psi”) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). In the instant case, Clement would not operate differently with the claimed range. Further, applicant places no criticality on the ranged claimed, indicating simply that the pressure is between 110 psi to 130 psi (¶[0005] “The positive pressure source provides the pressurized fluid between 110 psi to 130 psi”)
Furthermore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the positive pressure source of Clement to provide the pressurized fluid of between 110 psi to 130 psi for the purpose of controlling the pressure of impulses delivered to the catheter tube depending on factors including catheter length, catheter lumen size, burst strength, impulse duration, rest period duration, and other catheter configuration (Paragraph [0039]).
Regarding claim 7, Clement in view of Kirn, Caimi, and Rothenburg suggest the embolectomy system according to claim 1. Clement in view of Kirn, Caimi, and Rothenburg do not expressly disclose or suggest the positive pressure source providing a pulsed pressurized fluid that varies in pressure between 0.1 psi and 400 psi at a rate of between 1 Hz to 150 Hz. However, Ofek, in the same field of endeavor of removing occlusions in catheters, teaches a positive pressure source (38) providing a pulsed (Figure 8-10; Paragraph [0051]) pressurized fluid (Paragraph [0022]) that varies in pressure between 0.1 psi and 400 psi (Paragraph [0039]) at a rate of between 1 Hz to 150 Hz (Paragraph [0039]) for the purpose of controlling pressure of impulses delivered to the catheter tube depending on factors including catheter length, catheter lumen size, burst strength, impulse duration, rest period duration, and other catheter configurations (Paragraph [0039]), as well as to set the impulse frequency to match the resonant frequency of the catheter enabling improved propagation of the impulses distally through the lumen (Paragraph [0039]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the pressure of Clement as modified by Kirn and Caimi, from between 0.1 psi to 400 psi at a rate of between 1 Hz to 150 Hz as applicant appears to have placed no criticality on the claimed range (¶[0005] “The positive pressure source provides the pressurized fluid between 0.1 psi to 400 psi at a rate of between 1 Hz to 150 Hz”) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). In the instant case, Clement would not operate differently with the claimed range. Further, applicant places no criticality on the ranged claimed, indicating simply that the pressure is between 0.1 psi to 400 psi at a rate of between 1 Hz to 150 Hz (¶[0005] “The positive pressure source provides the pressurized fluid between 0.1 psi to 400 psi at a rate of between 1 Hz to 150 Hz”).
Furthermore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the positive pressure source of Clement to include providing a pulsed pressurized fluid that varies in pressure as taught by Ofek for the purpose of controlling pressure of impulses delivered to the catheter tube depending on factors including catheter length, catheter lumen size, burst strength, impulse duration, rest period duration, and other catheter configurations (Paragraph [0039]), as well as to set the impulse frequency to match the resonant frequency of the catheter enabling improved propagation of the impulses distally through the lumen (Paragraph [0039])
Regarding claim 11, Clement in view of Kirn, Caimi, and Rothenburg suggest the embolectomy system according to claim 1. Clement in view of Kirn, Caimi, and Rothenburg do not expressly disclose or suggest further including an ultrasound transducer coupled to the pressurized fluid conduit or the pressurized fluid and providing ultrasonic wave energy therethrough to the occlusion to fragment the occlusion. However, Ofek, in the same field of endeavor of removing occlusions in catheters, teaches including an ultrasound transducer (Paragraph [0040]) coupled (Paragraph [0040]) to a pressurized fluid conduit (Paragraph [0040]) and providing ultrasonic wave energy (Paragraph [0040]) therethrough to the occlusion (Paragraph [0040]) to fragment (Paragraph [0040]) the occlusion for the purpose of providing ultrasonic signals that are of sufficient frequency, intensity, and duty cycle to dislodge occlusions present in lumens (Paragraph [0040]).
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the pressurized fluid conduit of Clement to have included an ultrasound transducer as taught by Ofek for the purpose of providing ultrasonic signals that are of sufficient frequency, intensity, and duty cycle to dislodge occlusions present in lumens (Paragraph [0040]).
Regarding claim 12, Clement in view of Kirn, Caimi, and Rothenburg suggest the embolectomy system according to claim 1. Clement in view of Kirn, Caimi, and Rothenburg do not expressly disclose or suggest further including an ultrasound transducer coupled to the indwelling catheter and providing ultrasonic wave energy through the catheter to the occlusion to fragment the occlusion. However, Ofek, in the same field of endeavor of removing occlusions in catheters, teaches including an ultrasound transducer (Paragraph [0040]) coupled (Paragraph [0040]) to a catheter and providing ultrasonic wave energy (Paragraph [0040]) through the catheter to the occlusion to fragment the occlusion (Paragraph [0040]) for the purpose of providing ultrasonic signals that are of sufficient frequency, intensity, and duty cycle to dislodge occlusions present in lumens (Paragraph [0040]).
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the pressurized fluid conduit of Clement to have included an ultrasound transducer as taught by Ofek for the purpose of providing ultrasonic signals that are of sufficient frequency, intensity, and duty cycle to dislodge occlusions present in lumens (Paragraph [0040]).
Regarding claim 28, Clement in view of Kirn, Caimi, and Rothenburg suggest the embolectomy system according to claim 25. Clement in view of Kirn, Caimi, and Rothenburg do not expressly disclose or suggest the positive pressure source providing a pulsed pressurized fluid that varies in positive pressure between 0.1 psi and 400 psi at a rate of between 1 Hz to 150 Hz. However, Ofek, in the same field of endeavor of removing occlusions in catheters, teaches providing a pulsed (Figure 8-10; Paragraph [0051]) pressurized fluid (Paragraph [0022]) that varies in positive pressure between 0.1 psi and 400 psi (Paragraph [0039]) at a rate of between 1 Hz to 150 Hz (Paragraph [0039]) for the purpose of controlling pressure of impulses delivered to the catheter tube depending on factors including catheter length, catheter lumen size, burst strength, impulse duration, rest period duration, and other catheter configurations (Paragraph [0039]), as well as to set the impulse frequency to match the resonant frequency of the catheter enabling improved propagation of the impulses distally through the lumen (Paragraph [0039]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the pressure of Clement in view of Kirn, Caimi, and Rothenburg, from between 0.1 psi to 400 psi at a rate of between 1 Hz to 150 Hz as applicant appears to have placed no criticality on the claimed range (¶[0005] “The positive pressure source provides the pressurized fluid between 0.1 psi to 400 psi at a rate of between 1 Hz to 150 Hz”) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). In the instant case, Clement would not operate differently with the claimed range. Further, applicant places no criticality on the ranged claimed, indicating simply that the pressure is between 0.1 psi to 400 psi at a rate of between 1 Hz to 150 Hz (¶[0005] “The positive pressure source provides the pressurized fluid between 0.1 psi to 400 psi at a rate of between 1 Hz to 150 Hz”).
Furthermore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the positive pressure source of Clement to include providing a pulsed pressurized fluid that varies in pressure as taught by Ofek for the purpose of controlling pressure of impulses delivered to the catheter tube depending on factors including catheter length, catheter lumen size, burst strength, impulse duration, rest period duration, and other catheter configurations (Paragraph [0039]), as well as to set the impulse frequency to match the resonant frequency of the catheter enabling improved propagation of the impulses distally through the lumen (Paragraph [0039]).
Regarding claim 34, Clement in view of Kirn, Caimi, and Rothenburg suggest the embolectomy system according to claim 25. Clement in view of Kirn, Caimi, and Rothenburg do not expressly disclose or suggest further including an ultrasound transducer coupled to one of the pressurized fluid conduit, the indwelling catheter, or the pressurized fluid and configured to provide ultrasonic wave energy therethrough to the occlusion to fragment the occlusion. However, Ofek, in the same field of endeavor of removing occlusions in catheters, teaches an ultrasound transducer (Paragraph [0040]) coupled to the pressurized fluid conduit (Paragraph [0040]) and configured to provide ultrasonic wave energy (Paragraph [0040]) therethrough to the occlusion to fragment the occlusion (Paragraph [0040]) for the purpose of providing ultrasonic signals that are of sufficient frequency, intensity, and duty cycle to dislodge occlusions present in lumens (Paragraph [0040]).
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the pressurized fluid conduit of Clement to have included an ultrasound transducer as taught by Ofek for the purpose of providing ultrasonic signals that are of sufficient frequency, intensity, and duty cycle to dislodge occlusions present in lumens (Paragraph [0040]).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Clement (U.S. Publication No. 2014/0102445) in view of Kirn (U.S. Publication No. 2013/0190701), Caimi et al. (U.S. Patent No. 5,730,806), Caimi (U.S. Patent No. 5,730,806) and Rothenberg (U.S. Publication 2008/0097232), and further in view of Khosrowshahi (U.S. Patent No. 10,188,816).
Regarding claim 8, Clement in view of Kirn, Caimi, and Rothenburg suggest the embolectomy system of claim 1. Clement in view of Kirn, Caimi, and Rothenburg do not expressly disclose the negative pressure source providing a medical vacuum of between -11 psi and -3 psi. However, Khosrowshahi, in the same field of endeavor of removing build-up in catheters, teaches a negative pressure source (Col. 4 lines 65-67 and Col. 5 lines 1-5, aspirator) providing a medical vacuum of between -11 psi and -3 psi (Col. 4 lines 65-67 and Col. 5 lines 1-5) for the purpose of drawing fluids to a canister (Col. 4 lines 65-67 and Col. 5 lines 1-5).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the medical vacuum of Clement in view of Kirn, Caimi, and Rothenburg, to be from between -11 psi and -3 psi as applicant appears to have placed no criticality on the claimed range (¶[0005] “The negative pressure source provides a medical vacuum of between -11 psi and -3 psi”) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). In the instant case, Clement would not operate differently with the claimed range. Further, applicant places no criticality on the ranged claimed, indicating simply that the medical vacuum is between -11 psi and -3 psi (¶[0005] “The negative pressure source provides a medical vacuum of between -11 psi and -3 psi”).
Furthermore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to have modified the negative pressure source of Clement to provide a medical vacuum at -4 psi (200 mmHg) as taught by Khosrowshahi for the purpose of drawing fluids to a canister (Col. 4 lines 65-67 and Col. 5 lines 1-5).
Claims 9 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Clement (U.S. Publication No. 2014/0102445) in view of Kirn (U.S. Publication No. 2013/0190701), Caimi (U.S. Patent No. 5,730,806) and Rothenberg (U.S. Publication 2008/0097232), and further in view of Yang et al. (U.S. Publication No. 2020/0205845), henceforth referred to as Yang.
Regarding claim 9, Clement in view of Kirn and Caimi suggest the embolectomy system of claim 1. Clement in view of Kirn and Caimi do not expressly disclose the pressurized fluid conduit including a reinforcement member extending through a portion of a wall of the pressurized fluid conduit. However, Yang, in the same field of endeavor of removing obstructions from tube-like structures, teaches a fluid conduit (Paragraph [0294], catheter) including a reinforcement member (Paragraph [0294], nitinol coil) extending through a portion of a wall (Paragraph [0294]) of the fluid conduit (Paragraph [0294], catheter) for the purpose of providing kink resistance (Paragraph [0294]) to the conduit to resist kinking and help the conduit return to its original shape (Paragraph [0294]).
It would have been prima facie obvious to one of ordinary skill before the effective filing date to have incorporated the reinforcement member as taught by Look into the pressurized fluid conduit of Clement for the purpose of providing kink resistance (Paragraph [0294]) to the conduit to resist kinking and help the conduit return to its original shape (Paragraph [0294]).
Regarding claim 10, Clement in view of Kirn and Caimi and further in view of Yang suggest the embolectomy system according to claim 9. Clement in view of Kirn and Caimi and further in view of Yang further suggest the reinforcement member (Paragraph [0294] of Yang) including a nitinol coil (Paragraph [0294] of Yang).
Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Clement (U.S. Publication No. 2014/0102445) in view of Kirn (U.S. Publication No. 2013/0190701), Caimi (U.S. Patent No. 5,730,806) and Rothenberg (U.S. Publication 2008/0097232), and further in view of Sepetka (U.S. Patent No. 4,955,862).
Regarding claim 29, Clement in view of Kirn, Rothenberg, and Caimi suggest the embolectomy system according to claim 25. Clement in view of Kirn, Rothenberg, and Caimi do not expressly disclose the pressurized fluid conduit including a reinforcement member. However, Sepetka, in the same field of endeavor of guiding tubes intended for insertion, teaches a conduit lumen (lumen formed by element 36) including (Col. 5 lines 29-34) a reinforcement member (38) for the purpose of providing an uninterrupted contact surface for a guide wire in order to prevent contact between the guide wire and the inner surface of the tube (Col. 5 Lines 44-58).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to have modified the pressurized fluid conduit as discloses by Clement, to have included the reinforcement member as taught by Sepetka for the purpose of providing an uninterrupted contact surface for a guide wire in order to prevent contact between the guide wire and the inner surface of the tube (Col. 5 Lines 44-58).
Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Clement (U.S. Publication No. 2014/0102445) in view of Kirn (U.S. Publication No. 2013/0190701), Caimi (U.S. Patent No. 5,730,806) and Rothenberg (U.S. Publication 2008/0097232), and Sepetka (U.S. Patent No. 4,955,862) as applied to claim 29 above and further in view of Yang (U.S. Publication No. 2020/0205845).
Regarding claim 30, Clement in view of Kirn, Rothenberg, Caimi, and Sepetka suggest the embolectomy system according to claim 29. Clement in view of Kirn, Rothenberg, Caimi, and Sepetka discloses the reinforcement member (39 of Sepetka) including a metal coil (Col. 5 lines 35-40 of Sepetka), but does not expressly disclose the metal being nitinol. Yang, in the same field of endeavor of removing obstructions from tube-like structures, teaches a reinforcement member (Paragraph [0347]) including a nitinol (Paragraph [0347]) coil for the purpose of providing a coil made of a shape memory material (Paragraph [0347].
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the metal coil of Clement in view of Sepetka to have been a nitinol coil as taught by Yang, for the purpose of providing a coil made of a shape memory material (Paragraph [0347]).
Allowable Subject Matter
Claims 13, 15, 31, and 33 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claims 13 and 31 while independent claims 1 and 25 are considered to be obvious in light of Clement (U.S. Publication No. 2014/0102445) in view of in view of Kirn (U.S. Publication No. 2013/0190701), Caimi (U.S. Patent No. 5,730,806) and Rothenberg (U.S. Publication 2008/0097232), it would not have been obvious to one of ordinary skill in the art to have further includes a tip location system for tracking a magnetic element included with a distal portion of the pressurized fluid conduit in combination with the tip tracking system as disclosed in claims 1 and 25.
Werp (U.S. Patent No. 6,015,414), in the same field of endeavor of catheter intended to be inserted, teaches including a tip location system (Figures 5 and 6) for tracking a magnetic element (Figure 3B element 30) included (Col. 5 lines 43-58) with a distal portion (see above diagram of Figure 3A and 3B) of a fluid conduit (34) for the purpose of magnetically steering an implant in the body with high accuracy and controllability (Col. 3 lines 32-35), however there is no motivation present as to why one of ordinary skill in the art would combine this device with the device as claimed by claim 1 and claim 25 that includes a tip tracking system that tracks a tips location according to ECG signals as the ECG signal based system would already perform the tracking functions of the magnetic based tip location system. While one of ordinary skill may be motivated to modify the device with one of these systems individual, one of ordinary skill would not have been seen to have any motivation of modifying the device to include both of these features together in one device.
As such one of ordinary skill in the art would not have been motivated to modify the device suggested by Clement (U.S. Publication No. 2014/0102445) in view of in view of Kirn (U.S. Publication No. 2013/0190701), Caimi (U.S. Patent No. 5,730,806) and Rothenberg (U.S. Publication 2008/0097232) to have included a tip location system for tracking a magnetic element included with a distal portion of the pressurized fluid conduit in combination with the tip tracking system as disclosed in claims 1 and 25.
As such claims 13 and 31, if incorporated into independent claims 1 and 25 respectively would be considered to be allowable over the prior art.
Regarding claims 15 and 33, while independent claims 1 and 25 are considered to be obvious in light of Clement (U.S. Publication No. 2014/0102445) in view of in view of Kirn (U.S. Publication No. 2013/0190701), Caimi (U.S. Patent No. 5,730,806) and Rothenberg (U.S. Publication 2008/0097232), it would not have been obvious to one of ordinary skill in the art to have further includes first and second electrodes included with the distal portion of the pressurized fluid conduit wherein the first and second electrodes are configured for detecting an intra-luminal conductance at a first position and a second position respectively, and a lumen localization system for measuring changes in relative conductance between the first position and the second position to determine a change in intraluminal cross-section area, indicating a distal tip of the pressurized fluid conduit is proximate a distal tip of the indwelling catheter.
Kassab (U.S. Publication 20150080762), in the same field of endeavor of catheters intended for insertion, teaches including a first electrode (Figure 1 element 114) and a second electrode (116)included with a distal portion (Paragraph [0099]) of the pressurized fluid conduit (100), the first electrode (114) configured for detecting an intra-luminal conductance (Paragraph [0088]) at a first position and the second electrode (116) configured for detecting an intra-luminal conductance (Paragraph [0088]) at a second position, and a lumen localization system (500) for measuring changes (Paragraph [0107]) in relative (Paragraph [0098]) conductance between the first position and the second position to determine a change (Paragraph [0098]) in intraluminal cross-sectional area (Paragraph [0098]) indicating a distal tip of the fluid conduit is proximate the desired location for the purpose of proper placement of the conduit in relation of the patient in order to prevent patient complication (Paragraph [0003]) and provide real-time, feedback to the clinician without the assistance of x-ray guidance (Paragraph [0007]) however there is no motivation present as to why one of ordinary skill in the art would combine this device with the device as claimed by claim 1 and claim 25 that includes a tip tracking system that tracks a tips location according to ECG signals as the ECG signal based system would already perform the tracking functions of the intra-luminal conductance based tip location system. While one of ordinary skill may be motivated to modify the device with one of these systems individual, one of ordinary skill would not have been seen to have any motivation of modifying the device to include both of these features together in one device.
As such one of ordinary skill in the art would not have been motivated to modify the device suggested by Clement (U.S. Publication No. 2014/0102445) in view of in view of Kirn (U.S. Publication No. 2013/0190701), Caimi (U.S. Patent No. 5,730,806) and Rothenberg (U.S. Publication 2008/0097232) to have included first and second electrodes included with the distal portion of the pressurized fluid conduit wherein the first and second electrodes are configured for detecting an intra-luminal conductance at a first position and a second position respectively, and a lumen localization system for measuring changes in relative conductance between the first position and the second position to determine a change in intraluminal cross-section area, indicating a distal tip of the pressurized fluid conduit is proximate a distal tip of the indwelling catheter in combination with the tip tracking system as disclosed in claims 1 and 25.
As such claims 15 and 33, if incorporated into independent claims 1 and 25 respectively would be considered to be allowable over the prior art.
Conclusion
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/PETER DANIEL SMITH/Examiner, Art Unit 3781
/JACQUELINE F STEPHENS/Primary Examiner, Art Unit 3781