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 .
Response to Amendment
As of the reply filed 4/29/2026, claims 1-20 are pending. Claims 1-2, 7, 14, and 19 have been amended.
Response to Arguments
Applicant’s amendments to claims 14 and 19 have overcome the previously filed 35 U.S.C. 112(b) rejections, therefore these rejections are withdrawn.
Applicant’s arguments regarding the 35 U.S.C. 101 rejection of claim 13 are persuasive, therefore this rejection is withdrawn and examination continues in the context that “Claim 13 merely specifies the type of occlusion that the claimed system is configured to treat” (see page 5 of reply) as stated by the Applicant.
Applicant’s arguments with respect to claims 1, 14, and 19 have been considered but are moot in view of Applicant’s amendments to the claims because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 14-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zadno-Azizi et al. (US Patent No. 6,022,336).
With respect to claim 14, Zadno-Azizi et al. discloses a thermal system (see Fig. 1) for removing an occlusion from a blood vessel (col. 6, lines 45-51: “irrigation fluid could be supplied at one pressure through the irrigation pathway as indicated by the small arrows in FIG. 1. Due to the pressure differential in the chamber, fluid begins to flow toward the outer pathway, being assisted by the negative aspiration pressure. Thus, emboli in the chamber are swept through the outer pathway indicated by the arrows”), the thermal system comprising:
a multi-lumen tube (20 in Fig. 1, see multiple lumens 30 and 32, see also Fig. 2) comprising a proximal balloon (26) and an aspiration lumen (32, col. 7, lines 34-36: “irrigation can be performed through the inner pathway 30 and aspiration through the outer pathway 32, or vice versa”), the proximal balloon (26) configured to be inflated proximally of an occlusion (26 is proximal to the unmarked occlusive debris in Fig. 1);
an irrigation catheter (22 with lumen 30, see col. 7, lines 34-36: “irrigation can be performed through the inner pathway 30 and aspiration through the outer pathway 32, or vice versa”) configured to be advanced through and distally out of the aspiration lumen (32) of the multi-lumen tube (20) to the occlusion; and
a distal-balloon catheter (24) comprising a distal balloon (28) configured to be inflated distally of the occlusion (28 is distal relative to the unmarked occlusive debris in Fig. 1), the distal-balloon catheter (24) configured to be advanced through and distally out of the multi-lumen tube (20);
wherein the irrigation catheter (22) is configured to deliver heated fluid to the occlusion to soften or emulsify the occlusion (col. 7, lines 45-47: “irrigation fluid could be supplied at one pressure through the irrigation pathway as indicated by the small arrows in FIG. 1”, a source or means for heating the fluid is not explicitly claimed, 22 is configured to deliver heated fluid, see MPEP 2112.01: “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established”, In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977)); and
wherein the aspiration lumen (32) is configured to aspirate the softened or emulsified occlusion (col. 7, lines 39-42: “Fluid, together with emboli, are evacuated through the other pathway, being assisted by the aspiration pressure which is in reality a suction or negative pressure”).
Regarding claim 15, Zadno-Azizi et al. further discloses wherein the distal-balloon catheter (24 in Fig. 1 of Zadno-Azizi et al.) is advanced through the irrigation catheter (22) in the aspiration lumen (32).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-3, 5, 7-10, and 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Keating et al. (US PGPub 2021/0402157 A1) in view of Hansmann et al. (US PGPub 2005/0240151 A1).
With respect to claim 1, Keating et al. discloses a system for removing an occlusion from a blood vessel (see lesion L and plaque P in Figs. 2A-E), the system comprising:
an irrigation catheter (105 in Figs. 2A-E, see also cross-sectional view of 105 in Fig. 2F with flush lumen 119, PP [0050]: “fluid (e.g., saline, an anti-thrombogenic drug, a plaque sealant, etc.) can be injected into the cavity through the flush lumen 119”) comprising one or more apertures at a distal portion (see aperture 119 in distal portion 111 of 105 in Figs. 2A-E, see also distal end view in Fig. 2F);
wherein the irrigation catheter (105) is configured to be navigated through a blood vessel (see 105 navigate to lesion L in Figs. 2A-E).
However, Keating et al. fails to disclose that the system is a thermal system including at least one heating element disposed proximate to the one or more apertures to heat a fluid at the distal portion as the fluid exits the one or more apertures; or
wherein the irrigation catheter is configured to deliver the heated fluid to an occlusion to soften or emulsify the occlusion.
In the same field of intraluminal occlusion removal devices (abstract), Hansmann et al. teaches a thermal system (PP [0001]: “treatment of vascular occlusions with elevated temperatures”) comprising an irrigation catheter including one or more apertures (see fluid delivery lumens 30 in Fig. 3, PP [0040]: “A plurality of fluid delivery ports 58 can be positioned axially along the tubular body 12. Thus, a source of therapeutic compound coupled to the inlet port 32 provides a hydraulic pressure which drives the therapeutic compound through the fluid delivery lumens 30 and out the fluid delivery ports 58”) which includes at least one heating element (40 in Fig. 3) disposed proximate to the one or more apertures to heat a fluid at the distal portion as the fluid exits the one or more apertures (PP [0041]: “in one embodiment, fluid delivery ports closer to the proximal region of the energy delivery section 18 have smaller diameters than fluid delivery ports closer to the distal region of the energy delivery section 18, thereby allowing uniform delivery of therapeutic compound in the energy delivery section”); and
wherein the irrigation catheter is configured to deliver the heated fluid to an occlusion to soften or emulsify the occlusion (PP [0069]: “a heated solution (e.g., the therapeutic compound it self or a fluid passes through the lumen 44 of FIG. 6) can be delivered through the catheter to the treatment zone or the treatment site”, see also claim 8: “activating a heating element positioned within a treatment zone of the catheter comprises providing a heated fluid to the heat source”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the Keating et al. device according to the teachings of Hansmann et al. to include the one or more heating elements as claimed to soften the occlusion. One of ordinary skill in the art would have been motivated to perform this modification since Hansmann et al. teaches that “The efficacy of therapeutic compounds in reducing or removing a vascular occlusion can also be enhanced by increasing the temperature of the therapeutic compound that is provided at the treatment site” (PP [0003]), thus similarly enhancing the ability of the Keating et al. device to reduce or remove the target occlusion in a way that would not alter the main operating principle of the Keating et al. device.
Regarding claim 2, Keating et al. as modified Hansmann et al. by further discloses an aspiration catheter (126 in Figs. 2A-E of Keating et al., PP [0049]: “the delivery tube 126 can include an aspiration lumen”) configured to aspirate the softened or emulsified occlusion (see Figs. 2D-E where portions of lesion L are aspirated).
Regarding claim 3, Keating et al. as modified by Hansmann et al. further discloses wherein the irrigation catheter (105 in Figs. 2A-E of Keating et al.) and the aspiration catheter (126, PP [0049]: “the delivery tube 126 can include an aspiration lumen”) are configured to be concentrically positioned (see Figs. 2A-E, 126 is positioned within 105).
Regarding claim 5, Keating et al. as modified Hansmann et al. further discloses wherein the aspiration catheter (126 in Figs. 2A-E of Keating et al., PP [0049]: “the delivery tube 126 can include an aspiration lumen”) is configured to be disposed inside the irrigation catheter (105, 126 extends through 105 in Figs. 2D-E).
Regarding claim 7, Keating et al. as modified by Hansmann et al. further discloses wherein the heating element (40 in Fig. 3 of Hansmann et al.) is further configured to directly heat the occlusion (PP [0036]: “the heating assembly 42 is capable elevating the temperature of the treatment site”, directly elevating the temperature of the treatment site would also directly heat the occlusion).
Regarding claim 8, Keating et al. as modified by Hansmann et al. further discloses a crossing element (123 in Figs. 2C-E of Keating et al.) configured to be heated to facilitate penetrating the occlusion (PP [0048]: “when expanded in circumference, the plaque displacement apparatus 123 can contact the plaque P within the walls of the blood vessel, such that portions (fragments) F of plaque become displaced”, 123 is configured to be heated via contact with the heated fluid since it is in fluid communication with flush lumen 119).
Regarding claim 9, Keating et al. as modified by Hansmann et al. further discloses a distal balloon (109 in Figs. 2A-E of Keating et al.) configured to be inflated distal of the occlusion (109 is distal to lesion L).
Regarding claim 10, Keating et al. as modified by Hansmann et al. further discloses a proximal balloon (113 in Figs. 2A-E of Keating et al.) configured to be inflated proximal of the occlusion (113 is proximal to lesion L).
Regarding claim 12, Keating et al. as modified by Hansmann et al. further discloses a temperature sensor (20 in Fig. 6 of Hansmann et al.) configured to sense a temperature of the heated fluid (PP [0048]: “one or more temperature sensors 20 that are positioned within the energy delivery section 18”, PP [0049]: “In embodiments wherein the temperature sensors 20 are thermocouples, the temperature can be calculated from the voltage in the circuit using, for example, a sensing circuit 63, which can be located within the external control circuitry 100”), wherein the thermal system is configured to adjust the temperature of the heated fluid based on the sensed temperature (see control system 100 in Fig. 1, PP [0037]: “the heating assembly 42 comprises five groups G1, G2, G3, G4, G5 of heating members 40 that are electrically connected to each other. The five groups are also electrically connected to the control system 100”, PP [0005]: “A temperature sensor is in the treatment zone. A control system is configured to maintain the treatment zone at an elevated temperature for a specified amount of time”).
Regarding claim 13, Keating et al. as modified by Hansmann et al. further discloses wherein the occlusion comprises a thrombus (Keating et al. PP [0064]: “Methods for treatment using any of the example systems 100, 100A, 100B, 100C can further include a step whereby the thrombectomy device 142 is used to extract clot material or plaque P”).
Claims 4, 6, and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Keating et al. (US PGPub 2021/0402157 A1) in view of Hansmann et al. (US PGPub 2005/0240151 A1), as applied to claim 1 above, and further in view of Zadno-Azizi et al. (US Patent No. 6,022,336).
Regarding claim 4, Keating et al. as modified Hansmann et al. fails to disclose wherein the irrigation catheter is configured to be disposed inside the aspiration catheter, since in Figs. 2A-E of Keating et al. the aspiration catheter (126) is disposed within the irrigation catheter (105) instead.
In the same field of transluminal occlusion removal devices (abstract), Zadno-Azizi et al. teaches a catheter system (see Fig. 1) for removing debris from the vasculature of a patient, wherein the catheter system includes an irrigation catheter (22 with pathway 30, see arrows showing an irrigating flow, col. 7, lines 34-36: “irrigation can be performed through the inner pathway 30”) configured to be disposed inside of an aspiration catheter (20 with pathway 32, see arrows showing an aspiration flow, col. 7, lines 34-36: “aspiration through the outer pathway 32”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the combination as proposed to further include wherein the irrigation catheter is configured to be disposed inside the aspiration catheter. One of ordinary skill in the art would have been motivated to perform this modification because doing so would be a simple substitution of parts that would have yielded predictable results, simply swapping the aspiration/irrigation functionality of the Keating et al. device such that lumen 119 of catheter 105 aspirates material, and tube 126 provides a flush lumen. Keating et al. already contemplates a variety of placements for the aspiration lumen (PP [0049]: “the system 100 can include a lumen not illustrated to aspirate the dislodged portions F. For instance, the BGC 105 can include an additional lumen, the inner tube 121 can include an aspiration lumen, and/or the delivery tube 126 can include an aspiration lumen”), and Zadno-Azizi et al. teaches a substantially similar device illustrating both the claimed arrangement and the one displayed by the Keating et al. device, further acknowledging that the structural arrangements are interchangeable (col. 7, lines 34-36: “irrigation can be performed through the inner pathway 30 and aspiration through the outer pathway 32, or vice versa”). The modification as proposed would not affect the main operating principle of the Keating et al. device but would simply alter which catheter is for irrigation and which is for aspiration, changing the locations of the flush lumen and the aspiration lumen in a predictable way to one of ordinary skill in the art.
Regarding claim 6, Keating et al. as modified by Hansmann et al. fails to disclose wherein the one or more apertures of the irrigation catheter are disposed through a peripheral wall of the irrigation catheter, since the flush aperture (119 in Fig. 2F of Keating et al.) is a distal-end aperture.
In the same field of intraluminal catheters for the removal of occlusive material (abstract), Zadno-Azizi et al. teaches an irrigation catheter (14 in Figs. 9A-B) comprising one or more apertures (240 and 242, PP [0090]: “which contains side ports 240 near the distal end and/or an irrigation hole 242 at its distal end”), wherein the one or more apertures (240 and 242) are disposed through a peripheral wall of the irrigation catheter (240 are disposed through a wall of catheter 14).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the combination as proposed to include the teachings of Zadno-Azizi et al. and include wherein the one or more apertures of the irrigation catheter are disposed through a peripheral wall of the irrigation catheter. One of ordinary skill in the art would have been motivated to perform this modification as it is a simple substitution of aperture location that would have yielded predictable results, as Zadno-Azizi et al. teaches that peripheral apertures and a distal aperture are interchangeable options (PP [0090]: “which contains side ports 240 near the distal end and/or an irrigation hole 242 at its distal end”, emphasis added) that would not affect the main operating principle of the Keating et al. device. Irrigation would still occur with the aperture placement as proposed, and the modification would simply and predictably alter the location and directionality of the one or more apertures.
Regarding claim 11, Keating et al. as modified by Hansmann et al. fails to disclose wherein the proximal balloon is disposed on an aspiration catheter, since the proximal balloon of Keating et al. (see 113 in Figs. 2A-E) is disposed on an irrigation catheter (105).
In the same field of transluminal occlusion removal devices (abstract), Zadno-Azizi et al. teaches a catheter system (see Fig. 1) for removing debris from the vasculature of a patient, wherein the catheter system includes an irrigation catheter (30, see arrows showing an irrigating flow, col. 7, lines 34-36: “irrigation can be performed through the inner pathway 30”) configured to be disposed inside of an aspiration catheter (32, see arrows showing an aspiration flow, col. 7, lines 34-36: “aspiration through the outer pathway 32”). Zadno-Azizi et al. further teaches a proximal balloon (26), wherein the proximal balloon is disposed on the aspiration catheter (20 with pathway 32, see arrows showing an aspiration flow, col. 7, lines 34-36: “aspiration through the outer pathway 32”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the combination as proposed to switch the irrigation/aspiration catheter such that the proximal balloon is disposed on an aspiration catheter. One of ordinary skill in the art would have been motivated to perform this modification because doing so would be a simple substitution of parts that would have yielded predictable results, simply swapping the aspiration/irrigation functionality of the Keating et al. device such that lumen 119 of catheter 105 aspirates material, and tube 126 provides a flush lumen. Keating et al. already contemplates a variety of placements for the aspiration lumen (PP [0049]: “the system 100 can include a lumen not illustrated to aspirate the dislodged portions F. For instance, the BGC 105 can include an additional lumen, the inner tube 121 can include an aspiration lumen, and/or the delivery tube 126 can include an aspiration lumen”), and Zadno-Azizi et al. teaches a substantially similar device illustrating both the claimed arrangement and the one displayed by the Keating et al. device, further acknowledging that the structural arrangements are interchangeable (col. 7, lines 34-36: “irrigation can be performed through the inner pathway 30 and aspiration through the outer pathway 32, or vice versa”). The modification as proposed would not affect the main operating principle of the Keating et al. device but would simply alter which catheter is for irrigation and which is for aspiration, changing the locations of the flush lumen and the aspiration lumen in a predictable way to one of ordinary skill in the art such that the proximal balloon taught by Keating et al. is on an aspiration catheter as demonstrated by the Zadno-Azizi et al. reference.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Zadno-Azizi et al. (US Patent No. 6,022,336), as applied to claim 14 above, and further in view of Kapur et al. (US PGPub 2013/0325003 A1).
Regarding claim 16, Zadno-Azizi et al. fails to disclose a heated element configured to penetrate the occlusion for crossover.
In the same field of intraluminal clot removal devices (abstract), Kapur et al. teaches a device (see Fig. 1A) comprising a guidewire (proximal end of 122 in Fig. 4) including a heated element (122 in Figs. 5A-B) to penetrate the occlusion for crossover (see PP [0057]).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have further modified the combination as proposed to incorporate the teachings of Kapur et al. and include penetrating the occlusion with a heated element to facilitate crossover. One of ordinary skill in the art would have been motivated to perform this modification because doing so involves the use of a known technique (the use of a heated crossing guidewire for placing a device through an occlusion) to improve the known device of Zadno-Azizi et al. in the same way, by enhancing the device’s ability to cross total occlusions or harder chronic occlusions (PP [0059] of Kapur et al.).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Zadno-Azizi et al. (US Patent No. 6,022,336) and Kapur et al. (US PGPub 2013/0325003 A1), as applied to claim 16 above, and further in view of Simpson et al. (US Patent No. 5,462,529).
Regarding claim 17, Zadno-Azizi et al. as modified by Kapur et al. fails to disclose wherein the heated element is configured to be advanced through and distally out of the distal-balloon catheter (24 in Fig. 1 of Zadno-Azizi et al.), since the distal-balloon catheter (24) lacks a distal lumen for the guidewire of Kapur et al. to extend through and out of.
In the same field of intraluminal devices for the removal of occlusive debris (abstract), Simpson et al. teaches a device (see Figs. 8-10) comprising an aspiration catheter (110) comprising a proximal balloon (114), and a distal-balloon catheter (112) comprising a distal balloon (118), wherein a guidewire is configured to be advanced through and distally out of the distal-balloon catheter (see Fig. 10 where 156 extends through and beyond 112).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the combination as proposed according to the teachings of Simpson et al. such that the distal-balloon catheter (24 in Fig. 1 of Zadno-Azizi et al.) includes both an inflation lumen (144 in Fig. 8) and a guidewire lumen (154 in Fig. 10 with guidewire 156 extending through) such that the heated element is configured to be advanced through and distally out of the distal-balloon catheter. One of ordinary skill in the art would have been motivated to perform this modification as doing so constitutes a combination of prior art elements according to known methods to yield predictable results. Modifying the Zadno-Azizi et al. device to include the guidewire lumen of Simpson et al. would not have altered the main operating principle of the Zadno-Azizi et al. device, since both references are concerned with intraluminal chamber catheters for removing debris from the vasculature, but would have simply and predictably enabled the distal passage of a guidewire through the distal-balloon catheter as each combined element merely performs the same function as it does separately.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Zadno-Azizi et al. (US Patent No. 6,022,336), as applied to claim 14 above, and further in view of Hansmann et al. (US PGPub 2005/0240151 A1).
Regarding claim 18, Zadno-Azizi et al. fails to disclose a temperature sensor configured to sense a temperature of the heated fluid, wherein the thermal system is configured to adjust the temperature of the heated fluid based on the sensed temperature.
In the same field of intraluminal occlusion removal devices (abstract), Hansmann et al. teaches a thermal system (PP [0001]: “treatment of vascular occlusions with elevated temperatures”) comprising an irrigation catheter including one or more apertures (see fluid delivery lumens 30 in Fig. 3, PP [0040]: “A plurality of fluid delivery ports 58 can be positioned axially along the tubular body 12. Thus, a source of therapeutic compound coupled to the inlet port 32 provides a hydraulic pressure which drives the therapeutic compound through the fluid delivery lumens 30 and out the fluid delivery ports 58”) which includes at least one heating element (40 in Fig. 3) disposed proximate to the one or more apertures to heat a fluid at the distal portion as the fluid exits the one or more apertures (PP [0041]: “in one embodiment, fluid delivery ports closer to the proximal region of the energy delivery section 18 have smaller diameters than fluid delivery ports closer to the distal region of the energy delivery section 18, thereby allowing uniform delivery of therapeutic compound in the energy delivery section”); wherein the irrigation catheter is configured to deliver the heated fluid to an occlusion to soften or emulsify the occlusion (PP [0069]: “a heated solution (e.g., the therapeutic compound it self or a fluid passes through the lumen 44 of FIG. 6) can be delivered through the catheter to the treatment zone or the treatment site”, see also claim 8: “activating a heating element positioned within a treatment zone of the catheter comprises providing a heated fluid to the heat source”). Hansmann et al. further discloses a temperature sensor (20 in Fig. 6) configured to sense a temperature of the heated fluid (PP [0048]: “one or more temperature sensors 20 that are positioned within the energy delivery section 18”, PP [0049]: “In embodiments wherein the temperature sensors 20 are thermocouples, the temperature can be calculated from the voltage in the circuit using, for example, a sensing circuit 63, which can be located within the external control circuitry 100”), wherein the thermal system is configured to adjust the temperature of the heated fluid based on the sensed temperature (see control system 100 in Fig. 1, PP [0037]: “the heating assembly 42 comprises five groups G1, G2, G3, G4, G5 of heating members 40 that are electrically connected to each other. The five groups are also electrically connected to the control system 100”, PP [0005]: “A temperature sensor is in the treatment zone. A control system is configured to maintain the treatment zone at an elevated temperature for a specified amount of time”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the Zadno-Azizi et al. device according to the teachings of Hansmann et al. to include heating elements to facilitate delivering heated fluid and temperature sensors for monitoring the temperature of the heated fluid. One of ordinary skill in the art would have been motivated to perform this modification since Hansmann et al. teaches that “The efficacy of therapeutic compounds in reducing or removing a vascular occlusion can also be enhanced by increasing the temperature of the therapeutic compound that is provided at the treatment site” (PP [0003]), thus similarly enhancing the ability of the Keating et al. device to reduce or remove the target occlusion in a way that would not alter the main operating principle of the Keating et al. device. Additionally, one of ordinary skill in the art would have been motivated to modify the Keating et al. device to include temperature sensors in order to monitor and control the temperature at the treatment site “for optimal performance” (PP [0061]) when treating occlusions.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Zadno-Azizi et al. (US Patent No. 6,022,336) in view of Andrew et al. (US Patent No. 6,544,211 B1).
With respect to claim 19, Zadno-Azizi et al. discloses a method of applying fluid to an occlusion for removal (col. 6, lines 45-51: “irrigation fluid could be supplied at one pressure through the irrigation pathway as indicated by the small arrows in FIG. 1. Due to the pressure differential in the chamber, fluid begins to flow toward the outer pathway, being assisted by the negative aspiration pressure. Thus, emboli in the chamber are swept through the outer pathway indicated by the arrows”), the method comprising:
proximally positioning a multi-lumen tube (20 in Fig. 1) relative to an occlusion (see Fig. 1, the tube has lumens 30 and 32, shown also in Fig. 2, see also unmarked occlusive debris in Fig. 1, the tube 20 is proximal relative to that debris);
inflating a proximal balloon of the multi-lumen tube (balloon 26);
advancing a distal-balloon catheter (24) through the multi-lumen tube to position a distal balloon distal of the occlusion (28 is disposed on 24 and is positioned distal to the unmarked occlusive debris in Fig. 1);
inflating the distal balloon (28);
advancing an irrigation catheter (22 with irrigation lumen 30, col. 7, lines 34-36: “irrigation can be performed through the inner pathway 30 and aspiration through the outer pathway 32, or vice versa”) through an aspiration lumen (32, see col. 7, lines 34-36 as cited above) of the multi-lumen tube (20) to the occlusion;
delivering fluid by way of the irrigation catheter (22) to the occlusion to soften or emulsify the occlusion (col. 7, lines 45-47: “irrigation fluid could be supplied at one pressure through the irrigation pathway as indicated by the small arrows in FIG. 1”); and
aspirating the softened or emulsified occlusion (col. 7, lines 39-42: “Fluid, together with emboli, are evacuated through the other pathway, being assisted by the aspiration pressure which is in reality a suction or negative pressure”).
However, Zadno-Azizi et al. fails to disclose wherein the applied fluid is heated.
In the same field of intraluminal occlusion removal devices (abstract, col. 4, lines 41-42: “The present method may also be used in such areas as… vascular atherectomy/thrombectomy”), Andrew et al. teaches supplying heated fluid to a target tissue to destroy it and enable aspiration (abstract: “A biocompatible fluid is heated and contacted with target tissue so that the target tissue is melted while non-target tissue remains intact. As the target tissue is being melted it is also aspirated from the body”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the Zadno-Azizi et al. method to incorporate the teachings of Andrew et al. and include delivering heated fluid to an occlusion for removal. One of ordinary skill in the art would have been motivated to perform this modification because doing so would have constituted the use of a known method (the use of heated fluid as taught by Andrew et al.) to improve the similar method of Zadno-Azizi et al. ready for improvement to yield predictable results. The results would have been predictable because Andrew et al. explicitly teaches that using heated fluid is appropriate for the removal of thrombi within the vasculature (Andrew et al. col. 4, lines 41-42: “The present method may also be used in such areas as… vascular atherectomy/thrombectomy”) and thus the combination as proposed would not alter the main operating principle of the Zadno-Azizi et al. device or method.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Zadno-Azizi et al. (US Patent No. 6,022,336) in view of Andrew et al. (US Patent No. 6,544,211 B1), as applied to claim 19 above, and further in view of Kapur et al. (US PGPub 2013/0325003 A1).
Regarding claim 20, Zadno-Azizi et al. as modified by Andrew et al. further fails to disclose penetrating the occlusion with a heated element to facilitate crossover.
In the same field of intraluminal clot removal devices (abstract), Kapur et al. teaches a device (see Fig. 1A) comprising a guidewire (proximal end of 122 in Fig. 4) including an element (122 in Figs. 5A-B) configured to be heated to facilitate crossover through an occlusion (see PP [0057]).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have further modified the combination as proposed to incorporate the teachings of Kapur et al. and include penetrating the occlusion with a heated element to facilitate crossover. One of ordinary skill in the art would have been motivated to perform this modification because doing so involves the use of a known technique (the use of a heated crossing guidewire for placing a device through an occlusion) to improve the known device of Zadno-Azizi et al. in the same way, by enhancing the device’s ability to cross total occlusions or harder chronic occlusions (PP [0059] of Kapur et al.).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Bridget E. Rabaglia whose telephone number is (571)272-2908. The examiner can normally be reached Monday - Thursday, 7am - 5pm.
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.
/BRIDGET E. RABAGLIA/Examiner, Art Unit 3771
/TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771
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