DETAILED ACTION
Claims 1-5, 9, and 11-14 are amended. Claims 16-21 are newly amended claims. A complete action on the merits of pending claims 1-14 and 16-21 appears below.
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 .
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Response to Amendment
Acknowledgment is made to Applicant's amendments filed on 05/12/2026. With regards to the claim objections and 35 USC 112(b) rejections documented in the Non-Final Office Action sent on 02/23/2026, they’re overcome through Applicant’s amendments to the claims and are withdrawn.
Claim Objections
Claims 18 and 21 are objected to because of the following informalities:
Both claims 18 and 21 recite the limitation, “the distal end of the aspiration catheter” which should be “a distal end of the aspiration catheter”. The limitation was first introduced in claims 16 and 19 as “a distal end of the aspiration catheter.” However, claim 18 depends upon claim 17 which depends upon claim 1 and claim 21 depends upon claim 20 which depends upon claim 9, as such there was no previous mention of the limitation in claims 18 and 21 respectively or the claims they depend upon.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
Claim(s) 1-8 and 16-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stevens (US Patent No. 4936845), in view of Gencheff (US PGPUB No. 20150057694), further in view of Torrance (US PGPUB No. 20180280594), and even further in view of Nita (US Patent No. 5427118).
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Regarding claim 1, Stevens teaches, a method for creating a lumen through an obstruction within a venous system within a subject (Col. 2, line 50-52; As disclosed, the invention is to be used generally for obstructed blood vessels which includes vessels of the venous system. It is noted that Stevens in Col. 1, line 18-20, discusses, Arteriosclerosis, which mainly affects arteries, however, it does also on occasions also affect veins; further, Col. 3, line 24-41 explicitly teaches applicability to “blood vessels” broadly, which under BRI encompasses both arterial and venous systems, as venous obstructions like thrombi are known to be treatable by similar catheter based methods in the art), the method comprising:
locating an obstruction (Figure 1, obstruction (12)) in the venous system of the subject (Col. 3, line 24-41); and
positioning a non-rotatable wire guide (Figures 5-6, drive wire (40); Col. 4, line 1-4 and Col. 5, line 4-7; Where the drive wire (40) with distal tip (20a) is non-rotatable in the translational embodiment of Figures 5-6, as it imparts in-and-out axial translation without rotation) within the venous system of the subject (Col. 3, line 24-41 and Col. 6, line 36-38 disclose the positioning of drive catheter (10) which includes drive wire (40) into blood vessels, which under BRI includes the veins/venous system), wherein the non-rotatable wire guide (drive wire (40)) comprises a cutting head (Figures 5-6 and 11-12, distal tip (20a); Col. 6, line 28-35) and the cutting head (distal tip (20a)) is adjacent the obstruction (Col. 6, line 28-35), wherein the cutting head (distal tip (20a)) comprises a proximal end (See annotated Figure 12 above, (Proximal end)) and a distal end (See annotated Figure 12 above, (Distal end)), wherein the proximal end (Proximal end) comprises a concave shape (See annotated Figure 12 above, (Concave shape); Where a concave shape is one that curves inward) and the distal end (Distal end) comprises a convex shape (See annotated Figure 12 above, (Convex shape); Where a convex shape is one that curves outward), wherein the concave shape (Concave shape) comprises a most proximal end (See annotated Figure 12 above, (Most proximal end)) and a most distal end (See annotated Figure 12 above, (Most distal end)), wherein the proximal end (Proximal end) of the cutting head (bearing (50)) comprises a proximal diameter (See annotated Figure 12 above, (Diameter); Col. 6, line 38-46); and
applying energy (Figures 5-6; Col. 5, line 4-7 and line 26-44, disclosing motor energy for axial translation) to the non-rotatable wire guide (drive wire (40)) causing the cutting head (distal tip (20a)) of the non-rotatable wire guide (drive wire (40)) to vibrate (Under the broadest reasonable interpretation (BRI), the term “vibrate” will be interpreted as defined by the Merriam-Webster dictionary, “to move to and fro or from side to side”) without rotating (Col. 5, line 4-7 and line 26-44, disclosing in-and-out axial translation without rotation via the motor-driven reciprocating mechanism).
Stevens fails to teach, positioning a balloon catheter within the venous system of the subject adjacent the obstruction, wherein the balloon catheter comprises an expandable member and the expandable member is expanded within the venous system; positioning an aspiration catheter within the venous system of the subject, wherein the aspiration catheter extends beyond a distal end of the balloon catheter; wherein a ratio of a length between the distal end of the cutting head and the most proximal end of the concave shape relative to the proximal diameter of the cutting head is between 1.5:1 and 3:1; introducing a fluid into the balloon catheter or the aspiration catheter; aspirating the fluid during the vibrating of the cutting head; and wherein the applied energy is specifically ultrasonic energy.
Gencheff discloses an apparatus/device for penetrating an intravascular occlusion. Gencheff teaches, positioning a balloon catheter (Figures 3, 5, and 7, tubular portion (32); Paragraphs [0046] and [0049]) within the venous system (Figure 3, vessel passage (28)) of a subject adjacent an obstruction (Figure 3, occlusion (30)) (Paragraph [0050]), wherein the balloon catheter (tubular portion (32)) comprises an expandable member (Figures 4-5 and 7-9, inflatable bladder (48)) and the expandable member (inflatable bladder (48)) is expanded within the vasculature (Paragraph [0050]).
Torrance discloses a catheter assembly comprising a catheter, an operating head, and a system for removing obstructive material from a target site. Torrance teaches, positioning an aspiration catheter (Figure 2, catheter (60); Paragraph [0038]) within a vasculature of a subject (Paragraph [0035]), wherein the aspiration catheter extends beyond a distal end of the balloon catheter (as configuring the relative axial positions of nested catheters to enable aspiration at the cutting site distal to the balloon is a routine design choice in the art for localized debris removal, supported by Torrance’s Figure 2 and Paragraph [0038] showing the catheter (60) as an extendable aspiration element in a multi-component system); introducing a fluid into the aspiration catheter (Paragraph [0038], discloses, port (56) which communicates with catheter (60) may be operated as an aspiration or infusion port, where infusion port indicates that fluid is being introduced); and aspirating the fluid during operation of a cutting head (Figure 4, operating head (40); Paragraphs [0029] and [0035]-[0036]).
Nita discloses, a method for creating a lumen through an obstruction within a vascular system (Figures 6a-6g; Col. 7, line 59-68). Nita teaches, applying ultrasonic energy (Col. 8, line 12-15) to a non-rotatable wire guide (Figure 1, elongate guidewire body (14) of ultrasonic guidewire device (10); Col. 4, line 51-61; where the guidewire vibrates ultrasonically without rotation, as the energy causes “ultrasonic vibration of the distal tip (46)” for penetration, not rotational motion (Col. 8, line 12-22)) such that a cutting head (Figures 1-2 and 6c-6d, blunt or bulbous distal tip (46); Col. 4, line 51-61 and Col. 8, line 12-22) of the non-rotatable wire guide (elongate guidewire body (14) of ultrasonic guidewire device (10)) vibrates without rotating (Figures 6c-6d illustrating guidewire device (10) with distal tip (46) vibrating to create a passageway (104); Col. 8, line 14-22, “causing ultrasonic vibration of the distal tip 46 of the guidewire device 10. The guidewire device 10 is then slowly advanced into the occlusive lesion OL. The ultrasonic vibration of the distal tip 46 of the ultrasonic guidewire device 10 will facilitate passage of the guidewire 10 through the totally or near-totally occlusive lesion OL, thereby creating a longitudinal bore hole or passageway 104 through the occlusive lesion OL”; where ultrasonic vibration at 18-25kHz indicates high-frequency axial/back-and-forth oscillation/translation without rotation, as the guidewire is “slowly advanced” linearly while vibrating to bore through the lesion).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the method of Stevens such that it includes the step of positioning a balloon catheter within the venous system of the subject adjacent the obstruction, wherein the balloon catheter comprises an expandable member and the expandable member is expanded within the venous system as taught by Gencheff, the step of positioning an aspiration catheter within the venous system of the subject as taught by Torrance, wherein the aspiration catheter taught by Torrance extends beyond a distal end of the balloon catheter taught by Gencheff, further to include the steps of introducing a fluid into the aspiration catheter and aspirating the fluid during the vibrating of the cutting head as taught by Torrance, and to further modify the applied energy to the non-rotatable wire guide to be ultrasonic energy as taught by Nita, such that the ultrasonic energy causes the vibrating without rotation, as all the references and the claimed invention are directed to catheter systems utilized in the treatment of vascular obstructions. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Stevens such that it includes the step of positioning a balloon catheter within the venous system of the subject adjacent the obstruction, wherein the balloon catheter comprises an expandable member and the expandable member is expanded within the venous system as taught by Gencheff, the step of positioning an aspiration catheter within the venous system of the subject as taught by Torrance, wherein the aspiration catheter taught by Torrance extends beyond a distal end of the balloon catheter taught by Gencheff, further to include the steps of introducing a fluid into the aspiration catheter and aspirating the fluid during the vibrating of the cutting head as taught by Torrance, and to further modify the applied energy to the non-rotatable wire guide to be ultrasonic energy as taught by Nita, such that the ultrasonic energy causes the vibrating without rotation, as such a modification would enhance penetration through chronic or tough occlusions (e.g., crosslinked collagen in chronic clots) with high-frequency, low amplitude vibrations, reducing the risk of vessel wall damage compared to purely mechanical motion (Col. 8, line 17-20 of Nita) . Furthermore, such modifications would have been predictable, namely, to stabilize and center the catheter system by primarily preventing radial skewing and inhibiting axial movement. Additionally, will provide means for withdrawal of liquids and debris from a site of intervention. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the cutting head of Stevens to have the appropriate length between the distal end of the cutting head and the most proximal end of the concave shape such that a ratio of the length relative to the proximal diameter of the cutting head is between 1.5:1 and 3:1, especially given that Stevens discloses in Col. 6, line 38-46, the diameter/width of the cutting head (distal tip (20a)) being 0.025 inch and Col. 6, line 30-32, mentions that the cutting head (distal tip (20a)) has a length. Modifying this ratio would optimize performance factors such as tissue capture efficiency (by allowing deeper concave penetration) and cutting stability (by balancing length for controlled vibration without excessive flexing), as such dimensions are result-effective variables in vascular cutting devices per general practice in the art. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have “a ratio of a length between the distal end of the cutting head and the most proximal end of the concave shape relative to the proximal diameter of the cutting head is between 1.5:1 and 3:1,” since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involve only routine skill in the art. In re Aller.
Regarding claim 2, Stevens further teaches, further comprising re-positioning the cutting head (distal tip (20a)) (Col. 5, line 4-7 and Col. 5, line 21-25, disclose that through proximal coupling (60), a reciprocating in and out motion is applied to distal tip (20a), which means that distal tip (20a) is indeed being re-positioned through this motion).
Regarding claim 3, Stevens teaches aspects of claim 1 (See above rejection of claim 1).
Stevens fails to teach, further comprising aspirating the fluid.
Gencheff teaches, other aspects of claim 1 (See above rejection of claim 1).
Torrance teaches, further comprising aspirating the fluid (Paragraphs [0029] and [0038]).
Nita teaches, further aspects of claim 1 (See above rejection of claim 1).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the method of Stevens such that it includes aspirating the fluid as taught by Torrance, as all the references and the claimed invention are directed to catheter systems utilized in the treatment of vascular obstructions. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Stevens such that it includes aspirating the fluid as taught by Torrance, as such a modification would have been predictable, namely, to provide means for withdrawal of liquids and debris from a site of intervention.
Regarding claim 4, Stevens further teaches, wherein the cutting head (distal tip (20a) comprises a plurality of blades (Figures 11-12, grooves (186); Col. 6, line 28-35) evenly spaced around a circumference of the cutting head (Col. 6, line 32-35).
Regarding claim 5, Stevens further teaches, wherein the blades (grooves (186)) are substantially parallel to and aligned with a longitudinal axis of a shaft of the non-rotatable wire guide (The non-rotatable wire guide comprises drive wire (40) and distal tip (20a) in the reciprocating translational embodiment (Figure 5-6; Col. 5, line 4-7 and line 26-44). The shaft is drive wire (40), the elongate core element that extends from the proximal end to the distal tip and transmits the axial motion (Col. 4, line 1-4 and Col. 5, line 4-7). The blades are to be specific the raised lobes/lands (182) separated by grooves/ridges (186) on distal tip (20a) (Figures 11-12; Col. 6, line 27-34). These blades/grooves are indeed substantially parallel to and aligned with the longitudinal axis of drive wire (40), as clearly shown in Figures 11-12, where the grooves (186) and lands (184) run longitudinally, parallel to the central axis of the drive wire (40) that carries the tip. This provides a direct structural and functional correspondence, as drive wire (40) is the moving shaft that carries and orients the cutting features (Col. 6, line 42-43)).
Regarding claim 6, Stevens further teaches, wherein the blades (grooves (186)) have a proximal end (See annotated Figure 12 below, (Proximal end)), a distal end (See annotated Figure 12 below, (Distal end)), a height (See annotated Figure 12 below, (Height)) and a width (See annotated Figure 11 below, (Width)).
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Regarding claim 7, Stevens further teaches, wherein the height (Height) of at least one of the plurality of blades (grooves (186)) increases from the distal end (Distal end) to the proximal end (Proximal end) of the at least one of the plurality of blades (As clearly seen in Figure 12, the height/depth of grooves (186) is clearly increasing from the (Distal end) to the (Proximal end)).
Regarding claim 8, Stevens further teaches, wherein the width (Width) of at least one of the plurality of blades (grooves (186)) increases from the distal end (Distal end) to the proximal end (Proximal end) of the at least one of the plurality of blades (As clearly seen in Figure 11, the width of grooves (186) is clearly increasing from the (Distal end) to the (Proximal end)).
Regarding claim 16, modified Stevens teaches, wherein the aspiration catheter extending beyond the distal end of the balloon catheter causes the fluid to enter the venous system between the distal end of the balloon catheter and a distal end of the aspiration catheter (Stevens, as modified by Gencheff, teaches positioning a balloon catheter (Gencheff: tubular portion (32) with expandable bladder (48)) within the venous system adjacent the obstruction. Torrance teaches an aspiration catheter (catheter (60)) configured to extend beyond the distal end of an outer sheath/balloon structure. Torrance further discloses fluid introduction such that irrigation fluid flows distally in the annular space and enters the vessel between the distal end of the outer sheath/balloon catheter and the distal end of the inner aspiration catheter (Torrance: Figure 2, port (56) and nested catheter arrangement; Paragraphs [0038] and [0042]-[0043]). It would have been obvious to one of ordinary skill in the art to configure the aspiration catheter to extend beyond the balloon catheter so that fluid enters the venous system between the distal end of the balloon catheter and the distal end of the aspiration catheter in order to provide localized irrigation at the treatment site while the balloon provides stabilization).
Regarding claim 17, modified Stevens teaches, wherein the concave shape of the proximal end of the cutting head is configured to direct the fluid and clot debris into a suction lumen of the aspiration catheter to aid in aspiration of the fluid during the vibrating of the cutting head (Stevens teaches a cutting head having a concave proximal end (distal tip (20a) with concave geometry/land, see annotated Figure 12 above). Torrance teaches aspiration of fluid and debris through a suction lumen located proximal to or near the operating head (Figure 2, port (56); Figure 3, aspiration port (78); Paragraphs [0036] & [0041]). Nita teaches ultrasonic vibration of the cutting head. The combination renders obvious the use of the concave proximal shape of the cutting head to direct fluid and clot debris into the suction lumen of the aspiration catheter during vibration, as concave proximal geometries in vibrating/reciprocating cutters are known to channel debris proximally toward aspiration paths (Torrance, Paragraph [0043]; Stevens Col. 3, line 49–68 discussing fluid/debris management). One of ordinary skill would have found this configuration obvious to improve aspiration efficiency during ultrasonic vibration).
Regarding claim 18, modified Stevens teaches, wherein the fluid and the clot debris exit the venous system during the aspiration between a distal end of the aspiration catheter and a distal end of the non-rotatable wire guide (Torrance teaches that aspirated fluid and debris exit the vessel through the annular space between the distal end of the aspiration catheter and the operating element (Paragraphs [0015]-[0016], [0038] and [0041]). When combined with the vibrating non-rotatable wire guide of Nita and the cutting head of Stevens, it would have been obvious for the fluid and clot debris to exit the venous system during aspiration between the distal end of the aspiration catheter and the distal end of the non-rotatable wire guide. This annular exit path is a conventional design choice for efficient debris removal in coaxial catheter systems).
Claim(s) 9-14 and 19-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stevens, in view of Gencheff, and further in view of Torrance.
Regarding claim 9, Stevens teaches, a catheter system (Figures 5-6, drive catheter (10); Col. 5, line 4-7) comprising:
a non-rotatable wire guide (Figures 5-6, drive wire (40); Col. 4, line 1-4 and Col. 5, line 4-7; Where the drive wire (40) with distal tip (20a) is non-rotatable in the translational embodiment of Figures 5-6, as it imparts in-and-out axial translation without rotation) comprising a cutting head (Figures 5-6 and 11-12, distal tip (20a); Col. 6, line 28-35), wherein the cutting head (distal tip (20a)) comprises a proximal end (See annotated Figure 12 above, (Proximal end)) and a distal end (See annotated Figure 12 above, (Distal end)), wherein the proximal end (Proximal end) comprises a concave shape (See annotated Figure 12 above, (Concave shape); Where a concave shape is one that curves inward) and the distal end (Distal end) comprises a convex shape (See annotated Figure 12 above, (Convex shape); Where a convex shape is one that curves outward), wherein the concave shape (Concave shape) comprises a most proximal end (See annotated Figure 12 above, (Most proximal end)) and a most distal end (See annotated Figure 12 above, (Most distal end)), wherein the proximal end (Proximal end) of the cutting head (distal tip (20a)) comprises a proximal diameter (See annotated Figure 12 above, (Diameter); Col. 6, line 38-46), wherein the non-rotatable wire guide (drive wire (40)) is configured to vibrate (Under the broadest reasonable interpretation (BRI), the term “vibrate” will be interpreted as defined by the Merriam-Webster dictionary, “to move to and fro or from side to side”) without rotating (Col. 5, line 4-7 and line 26-44, disclosing in-and-out axial translation without rotation via the motor-driven reciprocating mechanism).
Stevens fails to teach, a balloon catheter comprising an expandable member; an aspiration catheter configured to extend beyond a distal end of the balloon catheter; and wherein a ratio of a length between the distal end of the cutting head and the most proximal end of the concave shape relative to the proximal diameter of the cutting head is between 1.5:1 and 3:1.
Gencheff discloses an apparatus/device for penetrating an intravascular occlusion. Gencheff teaches, a balloon catheter (Figures 3, 5, and 7, tubular portion (32); Paragraphs [0046] and [0049]) comprising an expandable member (Figures 4-5 and 7-9, inflatable bladder (48); Paragraph [0050]).
Torrance discloses a catheter assembly comprising a catheter, an operating head, and a system for removing obstructive material from a target site. Torrance teaches, an aspiration catheter (Figure 2, catheter (60); Paragraph [0038]) configured to extend beyond a distal end of the balloon catheter (as configuring the relative axial positions of nested catheters to enable aspiration at the cutting site distal to the balloon is a routine design choice in the art for localized debris removal, supported by Torrance’s Figure 2 and Paragraph [0038] showing the catheter (60) as an extendable aspiration element in a multi-component system).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Stevens such that it comprises a balloon catheter comprising an expandable member as taught by Gencheff, through which the non-rotatable wire guide of Stevens can pass through and to further comprise/integrate an aspiration catheter as taught by Torrance and which is configured to extend beyond a distal end of the balloon catheter taught by Gencheff, as all the references and the claimed invention are directed to catheter systems utilized in the treatment of vascular obstructions. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Stevens such that it comprises a balloon catheter comprising an expandable member as taught by Gencheff, through which the non-rotatable wire guide of Stevens can pass through and to further comprise/integrate an aspiration catheter as taught by Torrance and which is configured to extend beyond a distal end of the balloon catheter taught by Gencheff, as such modifications would have been predictable, namely, to stabilize and center the catheter system by primarily preventing radial skewing and inhibiting axial movement. Additionally, will provide means for withdrawal of liquids and debris from a site of intervention. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the cutting head of Stevens to have the appropriate length between the distal end of the cutting head and the most proximal end of the concave shape such that a ratio of the length relative to the proximal diameter of the cutting head is between 1.5:1 and 3:1, especially given that Stevens discloses in Col. 6, line 38-46, the diameter/width of the cutting head (distal tip (20a)) being 0.025 inch and Col. 6, line 30-32, mentions that the cutting head (distal tip (20a)) has a length. Modifying this ratio would optimize performance factors such as tissue capture efficiency (by allowing deeper concave penetration) and cutting stability (by balancing length for controlled vibration without excessive flexing), as such dimensions are result-effective variables in vascular cutting devices per general practice in the art. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have “a ratio of a length between the distal end of the cutting head and the most proximal end of the concave shape relative to the proximal diameter of the cutting head is between 1.5:1 and 3:1,” since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involve only routine skill in the art. In re Aller.
Regarding claim 10, Stevens further teaches, wherein the cutting head (distal tip (20a) comprises a plurality of blades (Figures 11-12, grooves (186); Col. 6, line 28-35) evenly spaced around a circumference of the cutting head (Col. 6, line 32-35).
Regarding claim 11, Stevens further teaches, wherein the plurality of blades (grooves (186)) are substantially parallel to and aligned with a longitudinal axis of the wire guide (drive wire (40); As clearly seen in Figures 11-12, a longitudinal axis of drive wire (40), which would run from along the very center/core of drive wire (40) from its proximal end to its distal end would clearly be substantially parallel to and aligned with grooves (186)).
Regarding claim 12, Stevens further teaches, wherein the plurality of blades (grooves (186)) have a proximal end (See annotated Figure 12 above, (Proximal end)), a distal end (See annotated Figure 12 above, (Distal end)), a height (See annotated Figure 12 above, (Height)) and a width (See annotated Figure 11 above, (Width)).
Regarding claim 13, Stevens further teaches, wherein the height (Height) of at least one blade of the plurality of blades (grooves (186)) increases from the distal end (Distal end) to the proximal end (Proximal end) of the at least one blade of the plurality of blades (As clearly seen in Figure 12, the height/depth of grooves (186) is clearly increasing from the (Distal end) to the (Proximal end)).
Regarding claim 14, Stevens further teaches, wherein the width (Width) of at least one blade of the plurality of blades (grooves (186)) increases from the distal end (Distal end) to the proximal end (Proximal end) of the at least one blade of the plurality of blades (As clearly seen in Figure 11, the width of grooves (186) is clearly increasing from the (Distal end) to the (Proximal end)).
Regarding claim 19, modified Stevens teaches, wherein the aspiration catheter extending beyond the distal end of the balloon catheter causes the fluid to enter the venous system between the distal end of the balloon catheter and a distal end of the aspiration catheter (Stevens, as modified by Gencheff, teaches positioning a balloon catheter (Gencheff: tubular portion (32) with expandable bladder (48)) within the venous system adjacent the obstruction. Torrance teaches an aspiration catheter (catheter (60)) configured to extend beyond the distal end of an outer sheath/balloon structure. Torrance further discloses fluid introduction such that irrigation fluid flows distally in the annular space and enters the vessel between the distal end of the outer sheath/balloon catheter and the distal end of the inner aspiration catheter (Torrance: Figure 2, port (56) and nested catheter arrangement; Paragraphs [0038] and [0042]-[0043]). It would have been obvious to one of ordinary skill in the art to configure the aspiration catheter to extend beyond the balloon catheter so that fluid enters the venous system between the distal end of the balloon catheter and the distal end of the aspiration catheter in order to provide localized irrigation at the treatment site while the balloon provides stabilization).
Regarding claim 20, modified Stevens teaches, wherein the concave shape of the proximal end of the cutting head is configured to direct the fluid and clot debris into a suction lumen of the aspiration catheter to aid in aspiration of the fluid during the vibrating of the cutting head (Stevens teaches a cutting head having a concave proximal end (distal tip (20a) with concave geometry/land, see annotated Figure 12 above) and configured to vibrate. Torrance teaches aspiration of fluid and debris through a suction lumen located proximal to or near the operating head (Figure 2, port (56); Figure 3, aspiration port (78); Paragraphs [0036] & [0041]). The combination renders obvious the use of the concave proximal shape of the cutting head to direct fluid and clot debris into the suction lumen of the aspiration catheter during vibration, as concave proximal geometries in vibrating/reciprocating cutters are known to channel debris proximally toward aspiration paths (Torrance, Paragraph [0043]; Stevens Col. 3, line 49–68 discussing fluid/debris management). One of ordinary skill would have found this configuration obvious to improve aspiration efficiency during ultrasonic vibration).
Regarding claim 21, modified Stevens teaches, wherein the fluid and the clot debris exit the venous system during the aspiration between a distal end of the aspiration catheter and a distal end of the non-rotatable wire guide (Torrance teaches that aspirated fluid and debris exit the vessel through the annular space between the distal end of the aspiration catheter and the operating element (Paragraphs [0015]-[0016], [0038] and [0041]). When combined with the vibrating non-rotatable wire guide and the cutting head of Stevens, it would have been obvious for the fluid and clot debris to exit the venous system during aspiration between the distal end of the aspiration catheter and the distal end of the non-rotatable wire guide. This annular exit path is a conventional design choice for efficient debris removal in coaxial catheter systems).
Response to Arguments
Applicant's arguments filed on 05/12/2026 have been fully considered but they are not persuasive.
With regards to the rejection of claim 1 under 35 U.S.C 103: Applicant argues that Stevens does not teach “vibrate,” that there is no motivation to combine Stevens with Nita, and that the combination would impermissibly change the principle of operation of Stevens. Applicant also challenges the motivation for the balloon/aspiration catheter arrangement and the result-effective variable analysis regarding the claimed ratio.
Examiner’s Response:
“Vibrate” limitation: Under the broadest reasonable interpretation (BRI), the term “vibrate” encompasses high-frequency axial oscillation or reciprocation. Nita expressly discloses ultrasonic energy (18–25 kHz) causing the distal tip to vibrate axially without rotation to bore through an occlusion (Nita, Col. 8, line 12-22; Figures 6c-6d). Stevens already teaches axial back-and-forth motion of the cutting head without rotation (Stevens, Col. 5, line 26-44). Substituting Nita’s ultrasonic driver for Stevens’ mechanical eccentric drive is a predictable substitution of one known axial-motion means for another to achieve the same result (penetrating an occlusion).
Motivation to Combine Stevens and Nita: There is ample motivation to combine. Both references are directed to devices for creating a lumen through vascular obstructions. Stevens recognizes the difficulty of crossing hardened obstructions with purely mechanical means (Stevens, Col. 1, line 18-Col. 2, line 2). Nita teaches that ultrasonic vibration improves the ability to penetrate tough occlusive material while reducing trauma (Nita, Col. 3, line 56-Col. 4, line 4 and Col. 8, line 17-20). A person of ordinary skill would have been motivated to apply Nita’s ultrasonic vibration to Stevens’ non-rotating reciprocating tip to better address chronic/hardened clots. The combination does not change the principle of operation of Stevens. Both Stevens and the modified device rely on axial motion of a non-rotating distal tip to create a lumen. Replacing a mechanical reciprocating drive with an ultrasonic transducer is a substitution of known equivalents that does not alter the fundamental principle of axial, non-rotational penetration (see MPEP 2143(I)(B); In re Ratti is inapposite because the principle of operation remains axial translation of a cutting tip). One of ordinary skill would have had a reasonable expectation of success.
Balloon Catheter & Aspiration Catheter Extension: The Office Action did not rely solely on “routine design choice.” Torrance discloses nested catheter systems in which an inner aspiration catheter extends beyond an outer sheath to enable localized aspiration and fluid delivery at the treatment site distal to the outer member (Torrance, Figure 2, port (56) and catheter (60); Paragraphs [0038] and [0041]-[0043]). Gencheff provides the centering balloon. Configuring the aspiration catheter to extend beyond the balloon to create an annular irrigation zone is a predictable variation supported by the combined teachings.
Claimed Ratio (1.5:1 to 3:1): Stevens discloses a cutting tip having both length and diameter (Col. 6, line 30-46). The ratio of length to proximal diameter is a result-effective variable that affects tissue capture, cutting efficiency, and vibrational stability. Optimizing such a dimensional ratio through routine experimentation is obvious (In re Aller, 220 F.2d 454 (CCPA 1955)). Applicant has not provided evidence that the prior art failed to recognize length-to-diameter as result-effective, nor has Applicant shown any unexpected results for the claimed range. The Antonie and Dupont v. Synvina line of cases does not apply where, as here, the general conditions (a tip with measurable length and diameter) are disclosed and optimization is routine.
Thus, the rejection of claim 1 and its dependents are maintained.
With regards to the rejection of claim 1 under 35 U.S.C 103: Applicant relies on the same arguments presented for claim 1. For the reasons set forth above, the rejection of independent claim 9 and its dependents are also maintained.
See updated rejections above, including those of newly added claims 16-21.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OSAMA NEMER whose telephone number is (571)272-6365. The examiner can normally be reached Monday-Friday 7:30-5:00.
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, Jackie Ho can be reached at (571)272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/O.N./Examiner, Art Unit 3771 /TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771
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