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 .
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.
Claim(s) 1-6, 8-9, and 11-16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Walzman (US 2020/0246014, hereinafter “Walzman”).
Referring to claim 1, Walzman discloses an apparatus (catheter 300 as shown in FIG. 5A), comprising:
a shaft 390 (FIG. 5A; ¶ [0236]) defining a lumen, the shaft including a distal portion configured to be disposed within a vessel lumen near a thrombus;
a plurality of fenestrations 330 (FIG. 5A; ¶ [0236]) disposed on the shaft, the plurality of fenestrations being fluidically coupled to the lumen, the lumen and the plurality of fenestrations configured to deliver a fluid into a treatment area containing the thrombus (¶ [0236]: “The rear hole 350 is capable of receiving a fluid from outside a patient's body, and each of the side holes 330 and front hole 340 are capable of ejecting fluid out of the central tube 390 into the vasculature of a patient.”);
at least one set of one or more agitation elements 360 (FIG. 5A; ¶ [0134]: “360 are all maceration loops.” ¶ [0250], ¶ [0254]) disposed at different locations along the distal portion of the shaft, each set of agitation elements including at least one agitation element configured to extend from an outer surface of the shaft to a wall of the vessel lumen (¶ [0263]), the sets of agitation elements 360 configured to independently translate and rotate to reshape or fragment the thrombus (in paragraph [0233] Walzman discloses loop structures 230 (which is equivalent to “the agitation element” as claimed in the claims) are made of a flexible material that allows the loop structures to bend and spring back to its original shape. Thus, the loop structures 360 (agitation elements 360) would have the same properties as the loop structures 230. Since loop structures 360 are not attached to each other, one of ordinary skill in the art will understand that loop structures 360 are independently translate and rotate with respect to each other).
Referring to claim 2, Walzman discloses the apparatus of claim 1, wherein each set of agitation elements 360 (FIG. 5A) includes a plurality of loops disposed circumferentially around the shaft (¶¶ [0254]-[0257]).
Referring to claim 3, Walzman discloses the apparatus of claim 2, wherein each of the plurality of loops 360 is configured to contact the wall of the vessel lumen and to deform to a shape of the vessel lumen (in paragraph [0243] Walzman discloses the diameter of tube 390 is from 1 French to 34 French. Examiner notes that 3 French catheter will have an diameter of 1 mm, thus, 30 French catheter will have an diameter of 10 mm. In paragraph [0263] Walzman discloses the loop structures 360 extend from the outer surface of tube 390 by a length equivalent to one half of the diameter of tube 390 or one time of the diameter of tube 390 or double the diameter of tube 390 or greater than six times the diameter of tube 390. Thus, tube 390 with a diameter of 1 mm with the loop structures 360 that extend from the outer surface of tube 390 by a length of double or triple the diameter of tube 390 will contact the wall of a vessel that has a 3 mm diameter).
Referring to claim 4, Walzman discloses the apparatus of claim 2, wherein each of the plurality of loops 360 is configured to have a length of between about 2 mm and about 20 mm (¶ [0243] and see rejection of claim 3 above and ¶ [0306]).
Referring to claim 5, Walzman discloses the apparatus of claim 2, wherein each of the plurality of loops 360 is configured to have a width of between about 2 mm and about 20 mm (FIG. 5A shows the width, which is the vertical length of loop structures 360, is about twice of the extended length, from the outer surface of tube 390 to the apex of loop structure 360, of the loop structures 360. Based on the disclosure in paragraph [0243] one of ordinary skill in the art will understand that Walzman discloses each of the loop structures 360 have a width of between about 2 mm and about 20 mm. ¶ [0306]).
Referring to claim 6, Walzman discloses the apparatus of claim 2, wherein the sets of agitation elements include a first set of agitation elements having a first plurality of loops and a second set of agitation elements having a second plurality of loops, the first plurality of loops being set at an angle relative to a longitudinal axis of the shaft that is different than an angle at which the second plurality of loops is set relative to the longitudinal axis of the shaft (¶¶ [0254]-[0257]).
Referring to claim 8, Walzman discloses the apparatus of claim 2, wherein the sets of agitation elements include a first set of agitation elements having a first plurality of loops and a second set of agitation elements having a second plurality of loops, the first plurality of loops being offset circumferentially from the second set of loops (¶¶ [0254]-[0257]).
Referring to claim 9, Walzman discloses the apparatus of claim 8, wherein the first plurality of loops is offset from the second plurality of loop by about 90 degrees or less (¶¶ [0254]-[0257]).
Referring to claim 11, Walzman discloses the apparatus of claim 1, wherein the plurality of fenestrations 330 (FIG. 5A; ¶¶ [0236], [0238]-[0241) is disposed in a pattern along a length of the distal portion of the shaft 390.
Referring to claim 12, Walzman discloses the apparatus of claim 1, wherein the plurality of fenestrations 330 is configured to deliver the fluid into the treatment area at a predefined rate or to deliver a predefined volume of the fluid over a set period of time into the treatment area (¶ [0267]).
Referring to claim 13, Walzman discloses the apparatus of claim 1, wherein the fluid includes at least one of: a thrombolytic fluid, a therapeutic fluid, a diagnostic fluid, or saline (¶¶ [0218]).
Referring to claim 14, Walzman discloses the apparatus of claim 1, wherein the shaft 390 is configured to be advanced to the treatment site over another medical device (FIG. 5A shows blood filter device, which includes cable 396 and filter body 395, is located inside tube 390. It is well known that the filter device have to deploy at the distal end of the treatment site before an atherectomy device or an angioplasty device is advanced to the treatment site. Thus, based on the disclosure in FIG. 5A one of ordinary in the art will understand that the device 300 is configured to be advanced to the treatment site over the cable 396).
Referring to claim 15, Walzman discloses the apparatus of claim 1, wherein the shaft is configured to be translated or rotated to translate or rotate the sets of agitation elements (¶ [0235]).
Referring to claim 16, Walzman discloses the apparatus of claim 1, wherein each of the sets of agitation elements includes at least two agitation elements 360 positioned at different locations about a circumference of the shaft 390 (¶¶ [0254]-[0257]).
Claim(s) 17, 24-26 and 29 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Imran (US 5,947,985, hereinafter “Imran”).
Referring to claim 17, Imran discloses an apparatus 101 (FIG. 4. Examiner notes that the main occlusion balloon catheter 12 as shown in FIG. 4 is the main occlusion balloon catheter 12 of the embodiment as shown in FIGS. 1-3. Similarly, the distal occlusion balloon catheter 13 of the embodiment as shown in FIG. 4 is the distal occlusion balloon catheter 13 as shown in FIGS. 1-3; col. 5, ln 9 to col. 6, ln 33), comprising:
a catheter 76 (distal occlusion catheter 13 as shown in FIGS. 1-3 and FIG. 4) defining a first lumen and including a first encapsulation element (balloon 79) disposed on a distal end of the catheter 76, the first lumen configured to receive a guidewire to enable the catheter to be advanced along the guidewire to a treatment area in a vessel lumen that includes a thrombus (col. 3, ln 33-37: “It should be appreciated that if desired, a movable guide wire can be provided with the distal occlusion balloon catheter 13. It is merely necessary to provide an additional guide wire lumen through which the guide wire can extend through the flexible elongate tubular member 76.”);
an outer sheath 12 (main occlusion balloon catheter 12 as shown in FIG. 4; col. 2, ln 13-35) defining a second lumen 19 and including a second encapsulation element (balloon 21 as shown in FIGS. 1-4) disposed on a distal end of the outer sheath 12, the first encapsulation element (balloon 79) and second encapsulation element (balloon 21 as shown in FIGS. 1-4) each configured to transition from an undeployed state to a deployed state, the first and second encapsulation elements in the deployed state collectively configured to isolate the treatment area including the thrombus (FIGS. 1-4; col. 2, ln 13-28);
an agitation device (therapeutic catheter 102 as shown in FIG. 4) disposable within the second lumen and defining a third lumen configured to receive the catheter (distal occlusion catheter 13 as shown in FIGS. 1-3 and FIG. 4) such that the agitation element can be advanced along the catheter, the agitation element including a plurality of agitation elements (col. 5, ln 12-27: “A modified therapeutic catheter 102 is provided in which the helix 56 on the therapeutic catheter 14 has been replaced by a basket-like structure 103 mounted on the distal extremity of the flexible elongate tubular member 36. The basket-like structure 103 is provided with a plurality of circumferentially spaced apart longitudinally extending spring-like arms 104 formed of a suitable material such as stainless steel or preferably of a shape memory alloy.” Each arm 104 has been interpreted as an agitation elements), the plurality of agitation elements 104 configured to be disposed between the first encapsulation element and second encapsulation element such that the plurality of agitation elements 104 can engage with the thrombus and reshape or fragment the thrombus (FIG. 4 shows arms 104 are engaging thrombus 64); and
a plurality of infusion ports 111 (FIG. 4) disposed on
Referring to claim 24, Imran discloses the apparatus of claim 17, further comprising an extracorporeal assembly, the extracorporeal assembly including a connector configured to couple the first and second encapsulation elements to an inflation source (FIG. 1 shows proximal occlusion catheter 12 includes fitting 26 and ports 27-29. Imran discloses port 27 is used for inflating balloon 21 (col. 2, ln 26-38)).
Referring to claim 25, Imran discloses the apparatus of claim 17, further comprising an extracorporeal assembly, the extracorporeal assembly including a connector configured to couple the plurality of fenestrations to an infusion source (Imran discloses irrigation liquid being supplied to ports 111 and distal occlusion catheter 13 is located inside the therapeutic catheter 13. Thus, Imran inherently discloses the proximal end of the therapeutic catheter 102 includes a fitting and ports similar to the proximal occlusion catheter 12 for receiving irrigation fluid and the distal occlusion catheter 13).
Referring to claim 26, Imran discloses the apparatus of claim 17, further comprising an extracorporeal assembly, the extracorporeal assembly including a connector configured to couple the second lumen of the outer sheath to a vacuum source such that particles of thrombus within the treatment area can be aspirated out of the treatment area via the second lumen by applying the vacuum (col. 2, ln 28-34: “A fitting 26 is mounted on the proximal extremity 17 of the flexible elongate tubular member 16 and is provided with a balloon inflation side port 27 in communication with the balloon inflation lumen 22. The fitting 26 is also provided with another side port 28 which serves as an aspiration port and which is in communication with the lumen 19.”).
Referring to claim 29, Imran discloses a method, comprising:
deploying first encapsulation element (balloon 79 as shown in FIG. 4) and second encapsulation element (balloon 21 as shown in FIG. 4) of a catheter system 101 disposed within a vessel lumen to isolate a treatment area of the vessel lumen containing a thrombus 64;
deploying a plurality of agitation elements 104 (FIG. 4) of the catheter system within the treatment area, the plurality of agitation elements when deployed being configured to contact a wall of the vessel lumen; and
translating and rotating the plurality of agitation elements to reshape or fragment the thrombus (col. 5, ln 40-55: “With the arms 104 in an expanded position, the therapeutic catheter 102 can be rotated from the proximal extremities to cause the arms 104 to remove the plaque 64 from the wall 62. At the same time or thereafter, the basket-like structure 103 can be moved forward and then back until the entire interior surface area of the wall 62 has been cleaned and the particles removed therefrom aspirated through the main occlusion balloon catheter 12.”).
Claim Rejections - 35 USC § 103
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 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.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Walzman.
Referring to claim 10, Walzman discloses the apparatus of claim 2, but fails to specifically discloses wherein the plurality of loops is formed of at least one of: PEEK, Pebax, or nitinol. In paragraph [0233] Walzman discloses loop structures are made from a flexible material that that allows the loop structures to bend and spring back to its original shape. In paragraph [0298] Walzman discloses “The various components of the described invention may comprise one or more materials. For example, according to some embodiments, the components can comprise one or more of a thermoplastic, a thermoset, a composite or a radiopaque filler.” In paragraph [0299] Walzman discloses “Thermoplastics include, but are not limited to, nylon, polyethylene terephthalate (PET), urethane, polyethylene, polyvinyl chloride (PVC) and polyether ether ketone (PEEK).” Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the application, to have made the microwire 370 of loop structures 360 from polyether ether ketone (PEEK) since it has been held that since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TUAN V NGUYEN whose telephone number is (571)272-5962. The examiner can normally be reached Monday - Friday 8:30 AM - 5:30 PM.
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/TUAN V NGUYEN/Primary Examiner, Art Unit 3771