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 .
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
PROSECUTION REOPENED
In view of the appeal brief filed on 11/14/2025, PROSECUTION IS HEREBY REOPENED. A new grounds of rejection is set forth below.
To avoid abandonment of the application, appellant must exercise one of the following two options:
(1) file a reply under 37 CFR 1.111 (if this Office action is non-final) or a reply under 37 CFR 1.113 (if this Office action is final); or,
(2) initiate a new appeal by filing a notice of appeal under 37 CFR 41.31 followed by an appeal brief under 37 CFR 41.37. The previously paid notice of appeal fee and appeal brief fee can be applied to the new appeal. If, however, the appeal fees set forth in 37 CFR 41.20 have been increased since they were previously paid, then appellant must pay the difference between the increased fees and the amount previously paid.
A Supervisory Patent Examiner (SPE) has approved of reopening prosecution by signing below:
Claim Objections
Claims 4 and 9 are objected to because of the following informalities:
Claim 4 should be amended to the following, “The method of claim 1, wherein the cutting head comprises a plurality of blades evenly spaced around a circumference of the cutting head.”
Claim 9 should be amended to the following, “A catheter system comprising:
a balloon catheter comprising an expandable member;
an aspiration catheter configured to extend beyond a distal end of the balloon catheter; and
a non-rotatable wire guide comprising a cutting head, wherein the cutting head comprises a proximal end and a distal end, wherein the proximal end comprises a concave shape and the distal end comprises a convex shape, wherein the concave shape comprises a most proximal end and a most distal end, wherein the proximal end of the cutting head comprises a diameter, 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 diameter of the cutting head is between 1.5:1 and 3:1, wherein the non-rotatable wire guide is configured to translate back and forth axially without rotating.”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
Claims 5-8 and 12-14 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 5 recites the limitation "the shaft". There is insufficient antecedent basis for this limitation in the claim. Claim 5 depends from claim 4 (which depends from claim 1), but neither claim 1 nor claim 4 recites or introduces “a shaft” as a structural element of the non-rotatable wire guide or any other component. A person of ordinary skill in the art cannot reasonably ascertain the scope of the claim, as it is unclear what structure constitutes “the shaft” to which the blades must be aligned/parallel. For the purpose of examination, “the shaft” is interpreted as referring to the non-rotatable wire guide (or its elongate body), consistent with the specification’s support (e.g., Paragraph [0069], describing blades “aligned with and/or parallel to the longitudinal axis of the non-rotatable wire guide (110), including the wire guide shaft (165) and the cutting head (200)”). However, appropriate amendment is required to clarify the claim language, such as by changing “the shaft” to “the non-rotatable wire guide” or introducing “a shaft” in a parent claim.
Claims 6-8 are rejected by virtue of their dependency on claim 5.
Claim 12 recites the limitation “the blades.” There is insufficient antecedent basis for this limitation in the claim. Claim 12 depends from claim 9, but claim 9 does not recite or introduce “blades” or “a plurality of blades.” A person of ordinary skill in the art cannot reasonably ascertain the scope of the claim, as it is unclear what structure constitutes “the blades.” For the purpose of examination, “the blades” is interpreted as referring to cutting features on the cutting head, consistent with the specification’s support (e.g., Paragraphs [0069]-[0070] describing blade geometry). However, appropriate amendment is required to clarify the claim language, such as by changing claim 12 to depend from claim 10 (which introduces “a plurality of blades”) or by reintroducing the blades explicitly in claim 12 (e.g., “wherein the cutting head comprises a plurality of blades, and the blades have a proximal end…”).
Claims 13-14 are rejected by virtue of their dependency on claim 12.
Claim Rejections - 35 USC § 103
Claim(s) 1-8 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 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)) such that the cutting head (distal tip (20a)) of the non-rotatable wire guide (drive wire (40)) translates back and forth axially 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 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 translation 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)) translates back and forth axially 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 translation 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 axial back-and-forth translation 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 translation 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 axial back-and-forth translation 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 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 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 a step of 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 a step of aspirating the fluid.
Gencheff teaches, other aspects of claim 1 (See above rejection of claim 1).
Torrance teaches, further comprising a step of 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 the step of 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 the step of 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, as best understood in view of the 112(b) issue noted above, Stevens further teaches, wherein the blades (grooves (186)) are substantially parallel to and aligned with a longitudinal axis of the non-rotatable wire guide (drive wire (40); Col. 6, line 42-43; 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 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)).
Claim(s) 9-14 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 diameter (See annotated Figure 12 above, (Diameter); Col. 6, line 38-46), wherein the non-rotatable wire guide (drive wire (40)) is configured to translates back and forth axially 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 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 Grencheff, 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 Grencheff, 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 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 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 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, as best understood in view of the 112(b) issue noted above, Stevens further teaches, wherein the 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 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 14, 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)).
Response to Arguments
Applicant’s arguments, see Appeal Brief, filed 11/14/2025, with respect to the rejection(s) of claim(s) 1-14 under 35 U.S.C. 103 have been fully considered and are persuasive.
Regarding the Mapping of “Non-Rotatable Wire Guide” and “Comprises a Cutting Head”: Applicant contends that Stevens fails to teach a “non-rotatable wire guide” that “comprises a cutting head” because the sleeve bearing (50) is a separate component from the drive wire (40) and distal tip (20a) assembly, and the drive wire/tip is rotatable in certain embodiments while the bearing remains non-rotatable.
The Examiner and Supervisory Patent Examiners (SPEs), Jackie Ho and Gregory Swiatocha, during the appeal conference held on 01/28/2026 carefully considered this argument in light of the specification and drawings of the instant application. The specification describes the “non-rotatable wire guide” (110) as an elongate, guidewire-like member that receives ultrasonic energy at its proximal end and transmits axial back-and-forth vibration/translation (without rotation) to a distal cutting head (200 or 700) attached thereto (see e.g., Figures 5-6, 6A and Paragraphs [0059]-[0061], [0067]-[0069]). The wire guide includes a shaft (169) with the cutting head affixed at its distal end, such that the assembly oscillates axially as a unit.
In prior Office Actions, the Examiner mapped the “non-rotatable wire guide” to the sleeve bearing (50) in Stevens, interpreting it as a non-rotatable sheath or tube. Upon further review consistent with the broadest reasonable interpretation (BRI) in view of the present disclosure, the Examiner agrees that the more accurate mapping is to the drive wire (40) with attached distal tip (20a) in the axial-reciprocation embodiment of Stevens (Figures 5-6 and 11-12; Col. 5, line 4-7 and Col. 6, line 28-35). In this embodiment, the drive wire (40) is reciprocated axially (in-and-out translation) without rotation to advance the distal tip (20a) through an obstruction (Col. 6, line 28-30). The distal tip (20a) is fixedly attached (e.g., by welding) to the distal end of the drive wire (40), such that the drive wire “comprises” the cutting head under the open-ended transitional term “comprises”.
The sleeve bearing (50) in Stevens is a separate, tightly coiled outer sheath/coil that surrounds and guides the drive wire (40) during insertion and motion (Col. 4, line 1-14). While the bearing (50) may remain stationary or minimally move, the active, motion-transmitting element analogous to the claimed non-rotatable wire guide is the drive wire (40) with its attached distal tip (20a). The fact that the drive wire may rotate in other embodiments of Stevens (e.g., Figure 10) does not negate the clear teaching of the non-rotating axial-reciprocation mode relied upon herein.
This updated mapping aligns with the specification’s disclosure of the wire guide as the ultrasonic-vibrating guidewire-like component (shaft + attached head), rather than a surrounding passage or sheath.
Regarding “Applying Ultrasonic Energy” to Cause Axial Translation Without Rotation: Applicant argues that Stevens lacks any disclosure of ultrasonic energy, that the axial translation in Stevens is achieved by mechanical means (motor (80) and reciprocating drive shaft (72)), and that neither inherency nor obvious substitution is supported by objective evidence of record.
The Examiner acknowledges that Stevens does not explicitly disclose ultrasonic energy. To address this limitation, the rejection now relies on Nita (US Patent No. 5427118) as teaching the application of ultrasonic energy to produce the claimed axial back-and-forth translation without rotation.
Nita teaches an ultrasonic guidewire device (10) comprising an elongate guidewire body (14) having a distal tip (46), wherein ultrasonic energy (preferably 18-25 kHz) is applied proximally to cause ultrasonic vibration of the distal tip, facilitating passage through an occlusive lesion by creating a longitudinal bore hole or passageway (Col. 7, Example 1, Figures 6a-6g, Col. 8, line 12-22, “Ultrasonic energy preferably having a frequency of 18-25 KHz is then passed through the ultrasonic guidewire device 10 causing ultrasonic vibration of the distal tip 46 … The ultrasonic vibration of the distal tip 46 … will facilitate passage … thereby creating a longitudinal bore hole or passageway 104”).
One of ordinary skill in the art would have had a rational underpinning to modify the drive wire (40) and the distal tip (20a) assembly of Stevens – which already achieves controlled axial back-and-forth motion without rotation – by applying ultrasonic energy as taught by Nita. Both references are directed to penetrating vascular obstructions and creating a passageway therethrough. Stevens teaches the functional requirement of axial translation without rotation using mechanical actuation. Nita demonstrates that ultrasonic vibration is a known, effective alternative for achieving precisely such axial motion in guidewire devices, with advantages including enhanced penetration of tough lesions via cavitation and microstreaming, and reduced risk of vessel trauma compared to purely mechanical reciprocation.
The proposed modification is therefore predictable, yields no more than the expected result of the same axial translation (but via ultrasonic means), and would have had a reasonable expectation of success in view of the established use of ultrasonic guidewires for vascular applications by the effective filing date of the claimed invention.
Applicant’s assertion that the Advisory Action’s prior statements regarding inherency or conclusory substitution lack support is noted. The current rejection relies on the explicit teachings of Nita combined with the motivation derived from the shared objectives of Stevens and Nita, not on inherency in Stevens alone.
Regarding Dependent Claims: Applicant’s traversal of dependent claims 2-8 and 10-14 is predicated on the alleged patentability of independent claims 1 and 9. As set forth above, the independent claims are properly rejected over the combination of references with the updated mapping and addition of Nita. Accordingly, the dependent claims remain unpatentable for at least the reasons applied to the independent claims from which they depend, as well as the specific additional limitations mapped in the rejection.
See updated rejections above.
Conclusion
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/O.N./Examiner, Art Unit 3771 /TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771