DETAILED ACTION
Claims 9 and 16 are amended. A complete action on the merits of pending claims 1-21 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 11/12/2025 which are entered. With regards to the specification objections documented in the Non-Final Office Action sent on 08/28/2025 all but one (not addressed in amendments or remarks) are overcome through Applicant’s amendments and arguments and are withdrawn (See updated objection below).
Specification
The disclosure is objected to because of the following informalities:
Page 8, line 24-25, “(such as via fluid introduced to the interior of the vessel a certain temperature)” should be “(such as via fluid introduced to the interior of the vessel at a certain temperature)”.
The suggested amendments are illustrative only and must be supported by the as-filed disclosure to avoid introduction of new matter (35 U.S.C. 132(a)). Appropriate correction is required.
Claim Rejections - 35 USC § 103
Claim(s) 1, 2, and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schwartz (US Patent No. 6746463 B1).
Regarding claim 1, Schwartz teaches, an apparatus for engaging a thrombus in a vessel (Figure 1, system (10); Col. 3, line 30-32; “for engaging a thrombus in a vessel” is intended use, system (10) is disclosed as a system for incising tissue in the vasculature of a patient (Col. 1, line 8-10)), comprising:
a catheter (Figure 1, catheter (12); Col. 3, line 32-34) having a first expandable element (Figure 1, balloon (18); Col. 3, line 34-35), the catheter further including a plurality of scrapers (Figure 1, cutting blades (26 (26a & 26b); Col. 3, line 48-51).
Schwartz teaches the opposite attachment: blades attached proximally (Figures 1-2B; Col. 3, line 60-65), extending distally alongside balloon, distal ends (40) unattached (Col. 4, line 10-14), adapted to insert between thrombus and vessel (functional; distal end capable).
It would have been obvious to one of ordinary skill in the art before the effective filing date to invert the attachment (distal vs. proximal), as there are only finite directions (2), and such would be predictable to achieve similar scraping/capture functionality in reverse direction (e.g., retraction for peripheral engagement). KSR v. Teleflex (550 U.S. 398, 2007): Obvious to try finite, predictable solutions. In thrombectomy, bidirectional devices are known; inversion allows retraction-based capture without deep penetration, reducing fragmentation (applicant’s problem). No change in principle – controlled incision via pulling remains; orientation swap is simple substitution.
Regarding claim 2, Schwartz further teaches, wherein the first expandable element (balloon (18)) comprises an inflatable balloon (Col. 4, line 31-34).
Regarding claim 8, Schwartz further teaches, wherein each of the plurality of scrapers (cutting blades (26 (26a & 26b)) is adapted to pass into a space between the thrombus and the vessel without buckling (Figure 5 along with Col. 4, line 45-65, describe the operation of the system (10) which includes the radial deployment of cutting blades (26) which are then used to incise tissue in the vasculature of a patient, as such, cutting blades (26 (26a & 26b) are indeed capable of passing into a space between the thrombus and the vessel without buckling).
Claim(s) 3, 4, 6, and 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schwartz, in view of Gershony (US Patent No. 8632559 B2).
Regarding claim 3, Schwartz teaches, the plurality of scrapers (cutting blades (26 (26a & 26b).
Schwartz fails to teach, wherein the plurality of scrapers each comprise a shape memory material.
Gershony discloses, a valvuloplasty catheter used in treating a stenosed aortic valve. Gershony teaches, a plurality of scrapers (Figures 2A-2B, proximal connecting links (26), scoring elements (22), distal connecting links (24) of metal cage (20)) each comprise a shape memory material (Col. 4, line 58-Col. 5, line 21; Where it is disclosed that the metal cage (20) is elastic (self-closes) and formed from a highly elastic metal, such as nitinol or spring stainless steel).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the plurality of scrapers of Schwartz such that each comprise a shape memory material as taught by Gershony, as both references and the claimed invention are directed to systems for incising tissue in the vasculature of a patient. 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 plurality of scrapers of Schwartz such that each comprise a shape memory material as taught by Gershony, as such a modification would have been predictable, namely, enable self-closing over the balloon once it is deflated.
Regarding claim 4, Schwartz teaches, the plurality of scrapers (cutting blades (26 (26a & 26b).
Schwartz fails to teach, wherein each of the plurality of scrapers is longer than the first expandable element.
Gershony teaches, wherein each of the plurality of scrapers (proximal connecting links (26), scoring elements (22), distal connecting links (24) of metal cage (20)) is longer than the first expandable element (Figures 2A-2B, balloon (18); Col. 4, line 58-62) (Col. 4, line 58-59, describe metal cage (2) which is comprised of proximal connecting links (26), scoring elements (22), distal connecting links (24) as being mounted over balloon (18), further, Col. 5, line 11-14, describes, distal connecting links (24) and proximal connecting links (26) being connected to the catheter shaft (12) or compliance tube (14) via collars (30 & 32) as seen in Figures 2A-2B, indicating, that indeed as they mount over balloon (18) they extend beyond it to anchor at the respective ends and are thus longer than balloon (18)).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the plurality of scrapers of Schwartz such that each of the plurality of scrapers is longer than the first expandable element as taught by Gershony, as both references and the claimed invention are directed to systems for incising tissue in the vasculature of a patient. 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 plurality of scrapers of Schwartz such that each of the plurality of scrapers is longer than the first expandable element as taught by Gershony, as such a modification would have been predictable, namely, provide a greater/larger clearance.
Regarding claim 6, Schwartz teaches, the plurality of scrapers (cutting blades (26 (26a & 26b).
Schwartz fails to teach, wherein each of the plurality of scrapers has a width greater than a thickness.
Gershony teaches, each of the plurality of scrapers (proximal connecting links (26), scoring elements (22), distal connecting links (24) of metal cage (20)) has a width greater than a thickness (Figure 2C; Col. 4, line 11-19 and line 31-32).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the plurality of scrapers of Schwartz such that each of the plurality of scrapers has a width greater than a thickness as taught by Gershony, as both references and the claimed invention are directed to systems for incising tissue in the vasculature of a patient. 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 plurality of scrapers of Schwartz such that each of the plurality of scrapers has a width greater than a thickness as taught by Gershony, as such a modification would have been predictable, namely, to provide flat struts/scrapers that can be placed along a balloon and track without buckling.
Regarding claim 7, Schwartz teaches, the plurality of scrapers (cutting blades (26 (26a & 26b).
Schwartz fails to teach, further including a web interconnecting the plurality of scrapers.
Gershony teaches, a web (Figure 2B, connection points (28) and zig-zag rings (29)) interconnecting the plurality of scrapers (Col. 5, line 1-11).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the plurality of scrapers of Schwartz such that a web interconnecting the plurality of scrapers is included as taught by Gershony, as both references and the claimed invention are directed to systems for incising tissue in the vasculature of a patient. 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 plurality of scrapers of Schwartz such that a web interconnecting the plurality of scrapers is included as taught by Gershony, as such a modification would have been predictable, namely, enable simultaneous and coordinated self-closing over the balloon once it is deflated.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schwartz, in view of Piccagli (US PGPUB No. 20170105758 A1).
Regarding claim 5, Schwartz teaches, the first expandable element (balloon (18)).
Schwartz fails to teach, further including a second expandable element distal of the first expandable element.
Piccagli discloses, a scoring balloon catheter for use in administering treatments to relieve a stenotic region, or to widen a constricted blood flow, bodily lumen, or tubular lumen. Piccagli teaches, a second expandable element (Figure 1, distal control balloon (146)) distal of a first expandable element (Figure 1, scoring balloon (140); Paragraph [0023]).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the system for incising tissue in the vasculature of a patient of Schwartz such that it includes including a second expandable element distal of the first expandable element as taught by Piccagli, as both references and the claimed invention are directed to systems for widening a constricted blood flow, bodily lumen, or tubular lumen. 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 system for incising tissue in the vasculature of a patient of Schwartz such that it includes including a second expandable element distal of the first expandable element as taught by Piccagli, as such a modification would have been predictable, namely, to improve position and alignment control.
Claim(s) 9-10, and 12-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Piccagli, in view of Giasolli (US PGPUB No. 20200155815 A1).
Regarding claim 9, Piccagli teaches, an apparatus (Figure 1, catheter system (100); Paragraph [0023]) for engaging a thrombus in a vessel (Figures 13A-13F; Paragraph [0054]), comprising:
a catheter (Figures 1-2, scoring balloon catheter (102); Paragraph [0023]) including a distal end portion (Figure 1 shows the distal end portion of scoring balloon catheter (102) that is primarily comprised of distal tip (128), distal control balloon (146), and distal portions of scoring elements (152)) having a first expandable element (Figure 1, distal control balloon (146); Paragraph [0023]), the catheter including a plurality of scrapers (Figure 1, scoring elements (152); Paragraph [0023]) extending at least partially alongside the first expandable element (Figures 1-2; Paragraph [0032]), a proximal end portion of the plurality of scrapers extending at least partially alongside a second expandable element (Figure 1, scoring balloon (140); Paragraph [0023]) proximal of the distal end portion (As clearly seen in Figure 1, indeed scoring balloon (140) is proximal of the distal end portion of scoring balloon catheter (102) that is primarily comprised of distal tip (128), distal control balloon (146), and distal portions of scoring elements (152)), the plurality of scrapers forming a cage lacking any expandable element therein (As seen in Figure 1, the scoring elements (152) are indeed forming a cage lacking any expandable element therein, specifically between distal control balloon (146) and scoring balloon (140)) and adapted to capture the thrombus (Paragraphs [0055]-[0056], describe scoring elements (152) coming into contact with lesion (410) seen in Figures 13A-13F, such that scoring elements (152) can then incise the lesion (410), as such, scoring elements (152) are indeed capable of capturing thrombus).
Piccagli fails to teach, at least one expandable collar attaching to at least one of the proximal end portion of the plurality of scrapers or the distal end portion of the plurality of scrapers, said at least one expandable collar at least partially surrounding at least one of the first expandable element or the second expandable element.
Giasolli discloses, balloon catheters with scoring elements for treating vascular lesions. Giasolli teaches, at least one expandable collar (Figures 15A-15B, rings (12, 13, 14); Paragraph [0132], “… the rings 12, 14 can be composed of a heat shrink material or a material with elastic properties …”; Paragraph [0150], “When the ring 12, 14 is made from an elastic material, such as rubber or polymer, or metallic alloy or a design with elastic properties like a spring, the ring 12, 14 can be used to provide tension on the cage 10 …”) attaching to at least one of the proximal end portion of the plurality of scrapers or the distal end portion of the plurality of scrapers (Paragraph [0108], “The cage 10 can include a first ring 12 and second ring 14, and a plurality of strips 16. Each strip can extend longitudinally between the first ring 12 and the second ring 14.”; Paragraph [0130], “… the strips 16 can be attached to the rings 12, 14 first before positioning around a balloon, or the cage can be assembled around a balloon.”), said at least one expandable collar at least partially surrounding at least one of the first expandable element or the second expandable element (Paragraph [0168], “… rings 12, 14, 13 can be used to retain the strip on the surface of the balloon 20.”; Paragraph [0131], “The rings 12, 14 can be any number of different materials including one or more of a metal, polymer, copolymer, elastomer, thermoplastic elastomer, glue, or hydrogel.”; as the rings are placed over the balloon to secure the strips, they surround the balloon, and their elastic/heat-shrink nature allows them to accommodate balloon expansion while providing tension).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the apparatus of Piccagli to include at least one expandable collar attaching to the ends of the scrapers and surrounding the expandable elements as taught by Giasolli, as both references and the claimed invention are directed to balloon catheters with scoring elements for treating vascular lesions. 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 apparatus of Piccagli to include at least one expandable collar attaching to the ends of the scrapers and surrounding the expandable elements as taught by Giasolli, as such a modification would have been predictable, namely, because such collars would enhance the secure attachment of the scoring elements (scrapers) to the balloons, preventing movement, sliding, tilting, or twisting of the elements during expansion and providing elastic tension to aid in returning the structure to a deflated configuration, thereby improving reliability and control during the procedure (as explicitly motivated by Giasolli, Paragraph [0132], “… a material with elastic properties that binds, captures, or restrains the plurality of strips 16 and prevents or limits the strips 16 from moving, sliding, tilting or twisting at any point along the length of the strips but especially at either end of the balloon 20.”; Paragraph [0150], “… the ring 12, 14 can be used to provide tension on the cage 10 to enable the cage 10 to return to the relaxed, deflated balloon 20 position.”). This modification involves applying a known technique (Giasolli’s expandable rings for securing scoring strips over a balloon) to improve a similar device (Piccagli’s scoring elements attached to control balloons for lesion incision) in the same way, yielding the predictable result of enhanced element stability and deflation assistance without compromising the thrombus-engaging function, consistent with MPEP 2143(I)(C).
Regarding claim 10, Piccagli further teaches, wherein a first end (Figure 2, distal end (156)) of each of the plurality of scrapers (scoring elements (152)) is attached to the first expandable element (distal control balloon (146); Paragraph [0032]) and a second end of each of the plurality of scrapers is attached to the second expandable element (Paragraph [0056], describes, “As scoring balloon (140) expands radially outward, it engages scoring elements (152).” As such, a second end/proximal end of each of the scoring elements (152) is indeed also attaching/engaging scoring balloon (140)).
Regarding claim 12, Piccagli further teaches, wherein the first and second expandable elements (distal control balloon (146) & scoring balloon (140)) each comprise an inflatable balloon (Paragraph [0025]).
Regarding claim 13, Piccagli further teaches, wherein the plurality of scrapers (scoring elements (152)) comprise a shape memory material (Paragraph [0032], discloses, “Scoring elements (152) may be constructed of any suitable material, such as, but not limited to, nitinol and stainless steel wire.”).
Regarding claim 14, Piccagli further teaches, wherein each of the plurality of scrapers (scoring elements (152)) is longer than the second expandable element (scoring balloon (140); Given that as seen in Figures 1-2 and disclosed in paragraph [0032]-[0033], where scoring elements (152) are extending over scoring balloon (140) to couple/bond to proximal and distal control balloons (134/146), indeed makes scoring elements (152) longer than scoring balloon (140)).
Regarding claim 15, Piccagli further teaches, wherein each of the plurality of scrapers (scoring elements (152)) is adapted for insertion between the thrombus and the vessel without buckling (Paragraphs [0055]-[0056], describe scoring elements (152) coming into contact with lesion (410) seen in Figures 13A-13F, such that scoring elements (152) can then incise the lesion (410), as such, scoring elements (152) are indeed capable for insertion between the thrombus and the vessel. Further, Paragraph [0032], discloses, “Scoring elements (152) may be of any shape suitable for the application including, but not limited to circular, rectangular, or square wire.” This aids in insertion between the thrombus and the vessel without buckling).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Piccagli, in view of Giasolli, and further in view of Gershony.
Regarding claim 11, Piccagli teaches, the plurality of scrapers (scoring elements (152)) and that they may be of any shape suitable for the application including, but not limited to circular, rectangular, or square wire (Paragraph [0032]).
Piccagli fails to teach, wherein each of the plurality of scrapers has a width greater than a thickness.
Giasolli teaches, aspects of the apparatus according to claim 9 (See above rejection of claim 9).
Gershony teaches, a plurality of scrapers (Figures 2A-2B, proximal connecting links (26), scoring elements (22), distal connecting links (24) of metal cage (20)), and wherein each of the plurality of scrapers (proximal connecting links (26), scoring elements (22), distal connecting links (24) of metal cage (20)) has a width greater than a thickness (Figure 2C; Col. 4, line 11-19 and line 31-32).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the plurality of scrapers of Piccagli such that each of the plurality of scrapers has a width greater than a thickness as taught by Gershony, as both references and the claimed invention are directed to systems for incising tissue in the vasculature of a patient. 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 plurality of scrapers of Piccagli such that each of the plurality of scrapers has a width greater than a thickness as taught by Gershony, as such a modification would have been predictable, namely, to provide flat struts/scrapers that can be placed along a balloon and track without buckling.
Claim(s) 16-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gershony, in view of Gordon (US Patent No. 5938645 A).
Regarding claim 16, Gershony teaches, an apparatus for engaging a thrombus in a vessel (Figure 1; Col. 2, line 32-43), comprising:
a catheter (Figure 1, valvuloplasty catheter (10); Col. 4, line 42-44) including a distal end portion (Figures 2A-2B) having an expandable element (Figures 1-2B, balloon/expansible shell (18); Col. 4, line 52-57), the catheter including a plurality of scrapers (Figures 2A-2B, proximal connecting links (26), scoring elements (22), distal connecting links (24) of metal cage (20); Col. 5, line 1-21) attached at one end portion (Figures 2A-2B, distal connecting links (24)) to the distal end portion of the catheter (Col. 5, line 11-13, disclose, “The distal connecting links (24), in turn, are attached to the catheter shaft (12) by a distal collar (30)…”) and extending at least partially alongside the expandable element (As clearly seen in Figures 2A-2B, proximal connecting links (26), scoring elements (22), distal connecting links (24) of metal cage (20) are indeed extending alongside the balloon (18)), a second opposite end portion (Figures 2A-2B, proximal connecting links (26)) of the plurality of scrapers being attached to an elastomeric collar (Figures 1-2B, proximal collar (32); note: while Gershony does not explicitly state “elastomeric,” the collar is part of a compliant structure allowing elongation and rotation (Col. 5, line 16-21, “In this way, when the expansible shell 18 is inflated or otherwise radially expanded, the compliance tube 14 can elongate (in the direction of the linear arrow in FIG. 2B) to accommodate any foreshortening and can also torque or rotate, as shown by the circular arrow in FIG. 2B.”), and use of elastomeric materials for such flexible collars in catheters is conventional, but for purposes of this rejection, the term is interpreted under the broadest reasonable interpretation (BRI) consistent with the specification (Page 12, line 16-17) describing the collar as comprising flexible material such as an elastomer) connected to the catheter proximal of the expandable element (Col. 5, line 13-14, discloses, “…the proximal connector links (26) are connected to the compliance tube (14) by a proximal collar (32). The compliance tube (14) is unattached to the catheter shaft (12) except for an attachment point (34) at its proximal end.”).
Gershony fails to teach, wherein the catheter includes a longitudinal gap along the catheter between the expandable element and the elastomeric collar.
Gordon discloses, a device used to break up and extract blood clots or thrombi which form within blood vessels. Gordon teaches, a longitudinal gap (Figure 5(b), slit (48); Col. 8, line 64-67) along the catheter (Col. 6, line 38-42, “A "partial rapid exchange" design can be accomplished using a long guidewire lumen with a slit from the proximal end, extending to several inches (less than 10 cm) from the distal end.”) in an embodiment including a distal expandable element (Figure 11(a), dilation balloon (80); Col. 10, line 5-11, “The embodiment shown in FIGS. 11(a) and 11(b) has a dilatation balloon 80 concentrically positioned around catheter 82. Catheter 82 comprises three lumens, namely, suction lumen 84, guidewire lumen 86, and inflation lumen 88. Balloon 80 is in fluid communication with inflation lumen 88 by means of any conventional configuration or arrangement, such as one or more inflation port 90.”), where this balloon embodiment is explicitly a variation of the embodiment with the slit in the guidewire lumen (Col. 9, line 54-56, “The embodiments of the invention shown in FIGS. 9(a) to 11(b) represent variations of the embodiment depicted in FIGS. 5(a) to 5(c).”), and the slit is in the guidewire lumen (46) (Col. 8, line 64-67, “A cross-sectional of the proximal portion of the catheter 18 is depicted in FIG. 5 (b) showing the internal guidewire lumen 46, which in this section of the catheter is provided with a slit 48 for easy removal of the guidewire.”), such that the slit extends along the catheter proximal of the distal end where the balloon is located in the variation.
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the catheter of Gershony to include a longitudinal gap (slit in the guidewire lumen) as taught by Gordon, located along the catheter between the expandable element and elastomeric collar (i.e., along the compliance tube (14) or shaft (12) proximal of the balloon (18) and distal of the proximal collar (32)), as both references and the claimed invention are directed to endovascular catheters for removing thrombus from blood vessels. 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 catheter of Gershony to include a longitudinal gap (slit in the guidewire lumen) as taught by Gordon, located along the catheter between the expandable element and elastomeric collar (i.e., along the compliance tube (14) or shaft (12) proximal of the balloon (18) and distal of the proximal collar (32)), as such a modification would have been predictable, namely, to provide a partial rapid exchange configuration that facilitates easy loading and removal of the catheter over the guidewire without disrupting the guidewire’s position in the vessel, thereby improving procedural efficiency during exchanges (as explicitly motivated by Gordon, Col. 6, line 47-53, “To remove the catheter, it is withdrawn over the wire to the point where the guidewire lumen is exposed and then the catheter is peeled off of the guidewire as it is withdrawn to the end of the slit. The last two inches are then pulled off. At this point another rapid exchange catheter can be advanced over the guidewire but not another thrombectomy catheter.”). This combination applies Gordon’s known rapid exchange slit technique to Gershony’s similar over-the-wire thrombectomy/engagement catheter in the same way to yield the predictable result of enhanced usability in vascular procedures, as both devices are guidewire-based catheters for thrombus interaction in blood vessels (MPEP 2143(I)(C)).
Regarding claim 17, Gershony further teaches, wherein each of the plurality of scrapers (proximal connecting links (26), scoring elements (22), distal connecting links (24) of metal cage (20)) has a width greater than a thickness (Figure 2C; Col. 4, line 11-19 and line 31-32).
Regarding claim 18, Gershony further teaches, wherein the expandable element (balloon/expansible shell (18)) comprises an inflatable balloon (Col. 4, line 52-62).
Regarding claim 19, Gershony further teaches, wherein the plurality of scrapers (proximal connecting links (26), scoring elements (22), distal connecting links (24) of metal cage (20)) comprise a shape memory material (Col. 4, line 58-Col. 5, line 21; Where it is disclosed that the metal cage (20) is elastic (self-closes) and formed from a highly elastic metal, such as nitinol or spring stainless steel).
Regarding claim 20, Gershony further teaches, wherein each of the plurality of scrapers (proximal connecting links (26), scoring elements (22), distal connecting links (24) of metal cage (20)) is longer than the expandable element (Col. 4, line 58-59, describe metal cage (2) which is comprised of proximal connecting links (26), scoring elements (22), distal connecting links (24) as being mounted over balloon (18), further, Col. 5, line 11-14, describes, distal connecting links (24) and proximal connecting links (26) being connected to the catheter shaft (12) or compliance tube (14) via collars (30 & 32) as seen in Figures 2A-2B, indicating, that indeed as they mount over balloon (18) they extend beyond it to anchor at the respective ends and are thus longer than balloon (18)).
Regarding claim 21, Gershony further teaches, wherein each of the plurality of scrapers (proximal connecting links (26), scoring elements (22), distal connecting links (24) of metal cage (20)) is adapted to pass into a space between the thrombus and the vessel without buckling (Col. 1, line 16-18 and Col. 2, line 32-43, disclose the apparatus/metal cage (20) as being used in valvuloplasty, where the balloon (18) expands and further allows metal cage (20) to also expand and engage with the stenotic material, such as calcified plaque, by fracturing and displacing it to increase the area of blood flow, this indicates that the proximal connecting links (26), scoring elements (22), distal connecting links (24) of metal cage (20) are inherently designed to withstand outward balloon expansion and press against tough calcific valve deposits, so they inherently resist buckling. They also do pass into spaces between plaque/calcific deposits and vessel/valve tissue when expanded, given that they press outward upon expansion, wedging between deposits/thrombus and vessel wall).
Response to Arguments
Applicant's arguments filed 11/12/2025 have been fully considered but they are not persuasive for the reasons set forth below.
Rejection of claim 1, 2, and 8 under 35 U.S.C. 103 as being unpatentable over Schwartz (US Patent No. 6746463 B1): Applicant contends that the rejection lacks a prima facie case of obviousness because it relies on impermissible hindsight, fails to provide a reasoned motivation with predictable results, and that the proposed modification (inverting the blade attachment direction in Schwartz) would change the principle of operation of Schwartz and teach away from the modification. These arguments are unpersuasive.
First, the rejection is not based merely on what "could" or "can" be done, but on what a person of ordinary skill in the art (POSITA) would have been motivated to do with a reasonable expectation of success. As set forth in the rejection, there are only two finite, predictable axial directions for attaching blades to a balloon catheter for vascular incision: (1) proximal attachment with distal extension (as in Schwartz), or (2) distal attachment with proximal extension (the claimed arrangement). Both orientations are known and used in the analogous art of balloon-deployed cutting/scoring devices for stenotic/vascular tissue, as evidenced by the prior art landscape (including Lary (US PGPUB No. 20030144677 A1), which teaches distal attachment on a tapered balloon with proximal blade extension along the taper; see Paragraph [0025], Figures 2-3). The finite nature of these choices, combined with the reasonable expectation that either would allow balloon inflation to deploy blades for incision during relative axial movement, supports obviousness under KSR v. Teleflex, 550 U.S. 398 (2007) ("When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp.").
The motivation is not hindsight-driven but is rooted in the problem Applicant seeks to solve and the teachings of the reference itself. Applicant's background (Page 1, line 16-Page 2, line 3) identifies the drawback of radial pushing of mesh stents through thrombus (fragmentation into small pieces, risk of embolism) and seeks a peripheral scraping/capture approach that reduces such breakup. Schwartz explicitly teaches retraction-based incision: after advancement through the stenosis with blades collapsed/covered, the inflated device is retracted proximally to incise with free distal ends (Col. 4, line 59–62: "the system 10 is then retracted in a proximal direction through the aortic valve 54 and into the aorta 56... the cutting edges 42 of respective blades 26 incise the aortic valve 54 …"). Inverting the attachment to distal-fixed/proximal-free would allow the free proximal ends to enter the interstitial space during the same retraction motion, achieving peripheral scraping and capture consistent with Applicant's objective of reducing fragmentation risk. This is not hindsight; it is applying the retraction-based incision principle of Schwartz to address the very problem Applicant identifies in the specification.
Applicant argues that inversion would prevent "controlled shallow incisions" and alter the principle of operation, citing Schwartz's objective of treating aortic valve stenosis with shallow leaflet incisions during withdrawal (Col. 1, line 8–10; Figure 5). This is not persuasive. The principle of operation in Schwartz is balloon inflation to radially deploy blades, followed by controlled axial movement (retraction) to incise stenotic tissue. Inversion does not change this: the balloon still deploys the blades radially, and retraction still provides controlled proximal movement for incision. The difference is merely which end is free — the free end still extends farther radially (Schwartz, Col. 4, line 10–22) and performs the cutting during pull. Applicant’s assertion that a reversed (proximal-free) blade would "directly pierce" the valve ignores that the blade orientation (angle α, 0°–45° per Schwartz Col. 4, line 19-22) and balloon taper would still allow shallow, controlled entry during retraction, just as Schwartz's distal-free blades do. No evidence shows that the free end must be distal for control; the control comes from the pulling motion itself, which Applicant acknowledges is more precise than pushing due to reduced buckling (Applicant's argument, page 3).
Applicant's safety concerns (potential exposure of sharp edges during advancement, risk of unintended cutting) are also unpersuasive. In Schwartz, the balloon is deflated during advancement, covering the blades (Schwartz, Col. 4, line 49–51: "… when the balloon 18 is in its deflated configuration, material of the balloon 18 will cover the blades 26 …"). Inversion does not inherently expose edges; the deflated balloon would still sheath them. Moreover, the art recognizes both directions as viable (e.g., Lary uses distal attachment/proximal extension with safe advancement when deflated, Paragraphs [0029]–[0033]).
In sum, the modification is a simple, predictable reorientation of known blade attachment to achieve the same retraction-based incision function in a configuration that aligns with Applicant's goal of peripheral capture during pull. The rejection is maintained.
Rejection of claims 9, 10, and 12–15 under 35 U.S.C. 102 over Piccagli (US PGPUB No. 20170105758 A1): Applicant notes that claim 9 has been amended to recite "at least one expandable collar attaching to at least one of the proximal end portion of the plurality of scrapers or the distal end portion of the plurality of scrapers, said at least one expandable collar at least partially surrounding at least one of the first expandable element or the second expandable element." Applicant asserts that Piccagli fails to disclose any such expandable collar.
This argument is persuasive in light of the amendment. Upon reconsideration, Piccagli teaches scoring elements (152, 252, 352) coupled directly to the proximal and distal control balloons (134/146, 234/246, 334/346) at bonding points (166), with overmolding/polymeric material (168) and flattening for adhesion (Paragraph [0033], Figure 7), but does not disclose an expandable collar that attaches to the scraper ends and at least partially surrounds one of the expandable elements (control balloons). The control balloons themselves are not collars, and no separate expandable collar/ring structure is shown or described surrounding a balloon while attaching scraper ends.
Accordingly, the rejection of claims 9-10 and 12–15 under 35 U.S.C. 102 over Piccagli is withdrawn. However, a new ground of rejection under 35 U.S.C. 103 over Piccagli in view of Giasolli (US PGPUB NO. 20200155815 A1) is set forth above; for brevity here, note that Giasolli teaches expandable rings/collars (12, 14) attaching to strip ends and surrounding/retaining on the balloon, Paragraphs [0128]–[0137], with motivation to improve secure attachment and tension return.
Rejection of claims 16–21 under 35 U.S.C. 102 over Gershony (US Patent No. 8632559 B2): Applicant notes that claim 16 has been amended to recite "wherein the catheter includes a longitudinal gap along the catheter between the expandable element and the elastomeric collar." Applicant asserts that Gershony does not disclose any such arrangement, as the balloon (18) is coextensive with the metal cage.
This argument is persuasive. Gershony's compliance tube (14) and proximal collar (32) are proximal of the balloon (18), but the metal cage (20) extends fully over and coextensive with the balloon (Figures 2A–2B; Col. 4, line 58–Col. 5, line 21), with no longitudinal gap (slit, slot, or separation) along the catheter shaft between the balloon and the proximal collar/compliance tube region. The compliance tube (14) is described as elongateable/torqueable but not as having a gap feature.
Accordingly, the rejection of claims 16–21 under 35 U.S.C. 102 over Gershony is withdrawn. However, a new ground of rejection under 35 U.S.C. 103 over Gershony in view of Gordon (US Patent No. 5938645 A) is set forth above; Gordon teaches a longitudinal slit/gap in a guidewire lumen along the catheter proximal of distal structures for partial rapid exchange, Col. 6, line 39-55 and Col. 8, line 64-67, with motivation to facilitate catheter removal/exchange while maintaining guidewire position.
See updated rejections above.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/O.N./Examiner, Art Unit 3771 /TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771