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 § 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.
Claim(s) 1-10, 13-17 and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Al (CN 111067591 A, translation attached) in view of Zhou (US 2014/0039358 A1).
Regarding claim 1, Al discloses (pgs. 1-6; figs. 1-10) a catheter (fig. 1) for treating occlusions in blood vessels (treats CTO, see background technique, pg. 1), comprising:
a tubular inner member (outer elongated member 201, pg. 4, fig. 3a) comprising:
a base segment (includes portion of 201 comprising lumens, annotated fig. 3a) defining:
a first lumen (211), and
a second lumen defining a fluid outlet port (212, pg. 4 describes lumens 211 and 212 serving as fluid inlet and outlet ports, such that 212 is considered to serve as the fluid outlet port);
an extension segment (inner elongated member 204) distal to the base segment (extends distal to the base segment, see annotated fig. 3a), wherein the extension segment has a reduced cross-section relative to the base segment (depicted in fig. 3a);
an emitter assembly (includes conductive wires 206, 207 and hollow cover 214) comprising:
a first insulated wire (206, considered to be insulated at least via insulating coating 202, pg. 5 also describes an insulating layer provided around each guide wire) extending through a third lumen (considered to extend through either lumen 209 or 210, pg. 4),
a second insulated wire (207, considered to be insulated at least via insulating coating 202, pg. 5 also describes an insulating layer provided around each guide wire), and
a conductive sheath (cover 214) wrapped circumferentially around the first insulated wire, the second insulated wire, and the extension segment (covers distal end of 201, fig. 3a, pg. 4), and
a cap or balloon (203, pg. 4) surrounding the emitter assembly (considered to surround emitter assembly at least at a distal end, pgs. 4-5, fig. 3a), said cap or balloon being fillable with conductive fluid (fluid 401, pgs. 4-5).
However, Al fails to disclose the first insulated wire extending specifically through the second lumen.
Zhou teaches (paras. [0044]-[0047]; figs. 3-4), in the same field of endeavor, a catheter for treating occlusions in blood vessels (abstract) comprising a wire (172) extending through a lumen fluidly communicating with a balloon cavity (128 is capable of circulating fluid, paras. [0044]-[0047]), for the purpose of absorbing ultrasound energy so as to increase the transmission of ultrasound energy to a thrombosis, so that fluid can be rapidly heated upon the application of energy or circulated to cool the emitting element (paras. [0037]-[0038] and [0046]).
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 device of Al such that the first insulated wire extends through the second lumen defining the fluid outlet port, in order to increase the transmission of energy to an occlusion, by rapidly heating fluid upon the application of energy or circulating fluid to cool the wires when desired, based on the teachings of Zhou (paras. [0037]-[0038] and [0046]). Note the combination would further consolidate the lumens and free up space within member 201.
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Annotated Figure 3A of Al
Regarding claim 2, Al (as modified) teaches the catheter of claim 1. Al further discloses wherein the extension segment is configured to receive a guidewire (205, pg. 6, fig. 3a).
Regarding claim 3, Al (as modified) teaches the catheter of claim 1. Al further discloses wherein the extension segment is connected to a third lumen (208) within the base segment (fig. 2b), and wherein the extension segment is formed by removing walls of the first lumen and the second lumen at the distal end of the inner member (considered to be capable of being formed by removing walls of lumens formed in member 201, note the limitation “formed by removing walls of the first lumen and the second lumen at the distal end of the inner member” is being treated as a product by process limitation, in which determination of patentability is based on the product itself; since Al discloses an extension segment at a distal end of the inner member including a first lumen and a second lumen, the limitation is considered to be met, see MPEP 2113).
Regarding claim 4, Al (as modified) teaches the catheter of claim 1. Al further discloses wherein the first lumen defines a fluid inlet port (pg. 4 describes lumens 211 and 212 serving as fluid inlet and outlet ports, such that lumen 211 is considered to serve as the fluid inlet port), and wherein the fluid inlet port comprises a tubing extending from the first lumen (lumens are fluid channels leading to the tip lumen, channel of 201 is considered to comprise tubing, note the claim limitation does not specify how the tubing extends, such that the tubing is considered to extend within the first lumen as a channel of 201).
Regarding claim 5, Al (as modified) teaches the catheter of claim 4.
However, Al (as modified) fails to teach wherein the second wire extends through the first lumen.
Zhou teaches (paras. [0044]-[0047]; figs. 3-4), in the same field of endeavor, a catheter for treating occlusions in blood vessels (abstract) comprising a wire (172) extending through a lumen fluidly communicating with a balloon cavity (128 is capable of circulating fluid, paras. [0044]-[0047]), for the purpose of absorbing ultrasound energy so as to increase the transmission of ultrasound energy to a thrombosis, so that fluid can be rapidly heated upon the application of energy or circulated to cool the emitting element (paras. [0037]-[0038] and [0046]).
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 device of Al (as modified) such that the second wire extends through the first lumen, in order to increase the transmission of energy to an occlusion, by rapidly heating fluid upon the application of energy or circulating fluid to cool the wires when desired, based on the teachings of Zhou (paras. [0037]-[0038] and [0046]). Note the combination would further consolidate the lumens and free up space within member 201.
Regarding claim 6, Al (as modified) teaches the catheter of claim 5. Al further discloses wherein a distal end of the first lumen is sealed (considered to be sealed by crown, pgs. 2 and 4) to expose only a portion of the second wire (combination considered to further teach a distal portion of wire 207 exposed to cavity by lumen) and a portion of the tubing (portion of tubing considered to be exposed to a degree, note the claim language does not specify what the term “expose” is relative to (e.g. exposed relative to what other structure), such that the tubing formed by the lumen/201 is considered to be exposed internally to the device).
Regarding claim 7, Al (as modified) teaches the catheter of claim 1. Al further discloses wherein the conductive fluid is configured to flow around the conductive sheath (flows within cavity 215 formed by cover 214, considered to flow internally around 214, fig. 3a) and exit via a crack (at interface of cavity 215 and 212, note this appears consistent with the instant spec., describing the crack as a portion of a lumen) formed by the outside of the conductive sheath and the second lumen (outer portion of 214 and 212 considered to form crack, since 214 and 212 create boundaries of cavity 215 through which fluid is circulated and then exits through 212).
Regarding claim 8, Al (as modified) teaches the catheter of claim 1. Al further discloses wherein the emitter assembly comprises: a first electrode pair comprising the conductive sheath and a conductive distal end of the first insulated wire spaced apart from the conductive sheath (first arc which interacts with cover 214, pgs. 4-5); and a second electrode pair comprising the conductive sheath and a conductive distal end of the second insulated wire spaced apart from the conductive sheath (second arc which interacts with cover 214, pgs. 4-5).
Regarding claim 9, Al (as modified) teaches the catheter of claim 8. Al (as modified) further teaches wherein the first electrode pair and the second electrode pair are located approximately 180 degrees apart circumferentially around the conductive sheath (combination considered to further teach wires spaced similarly to lumens in fig. 2b, depicted as 180 degrees apart).
Regarding claim 10, Al (as modified) teaches the catheter of claim 1. Al further discloses wherein the proximal ends of the first wire and the second wire are connectable to a pulsed voltage source (105, pg. 4; fig. 1).
Regarding claim 13, Al (as modified) teaches the catheter of claim 1.
Al further discloses wherein the cap or balloon is flexible (via elastic material and expanded state, pgs. 4-6) and can be expanded by inflation with the conductive fluid (pgs. 4-5).
However, Al (as modified) fails to teach wherein the maximum inflated diameter of the flexible cap or balloon is no more than 15% greater than the deflated diameter of the flexible cap.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Al (as modified) to have a maximum inflated diameter of the flexible cap or balloon to be no more than 15% greater than the deflated diameter, since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Al (as modified) would not operate differently with the claimed diameter and since crown 203 of Al extends distally during expansion to contact a CTO and apply shock waves, the device would function appropriately having the claimed diameter. Further, it appears that applicant places no criticality on the range claimed, indicating simply that the claimed range is exemplary (para. [0078] of the published application).
Regarding claim 14, Al (as modified) teaches the catheter of claim 1.
Al further discloses wherein the cap or balloon is made of material having elastomeric properties (composed of an elastic material, pg. 4).
However, Al (as modified) fails to teach after being inflated, the cap or balloon returns to a low profile configuration when deflated.
Zhou teaches (para. [0063]), in the same field of endeavor, a catheter for treating occlusions in blood vessels (abstract), comprising a balloon returning to a low profile configuration when deflated (para. [0063]), in order to provide the treatment system a lower profile for removal (para. [0063]).
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 device of Al (as modified) such that crown 203 of Al returns to a low profile configuration when deflated, in order to provide the system with a lower profile for removal from the blood vessel, conforming the crown along portions of the device for easier removal, based on the teachings of Zhou (para. [0063]).
Regarding claim 15, Al (as modified) teaches the catheter of claim 1. Al further discloses wherein the cap comprises an extruded polymer tube (cap may be composed of polyurethane, considered to be a polymer tube, further note the term “extruded” is being treated as a product by process limitation, in which determination of patentability is based on the product itself; since Al discloses crown 203 formed of a polymer material, the limitation is considered to be met, see MPEP 2113).
Regarding claim 16, Al (as modified) teaches the catheter of claim 1. Al further discloses wherein the cap or balloon is a balloon (crown 203 formed of an elastic material, considered to be a balloon), and wherein when the balloon is in a deflated state, a surface area of the balloon is small enough that the balloon is not folded when the catheter is advanced into a blood vessel (considered to be state of crown 203 prior to the expanded state, depicted as not folded in fig. 3a, see fig. 4a depicting the expanded state of the crown).
Regarding claim 17, Al (as modified) teaches the catheter of claim 1. Al further discloses wherein the first wire and the second wire are flattened (distal ends of wires are flush to the distal side 213 of 201, considered to be flattened at distal ends to remain flush with the distal side, pg. 4, fig. 3a).
Regarding claim 19, Al (as modified) teaches the catheter of claim 1.
However, with respect to the cited embodiment, Al (as modified) fails to teach further comprising a soft tip that tapers toward the distal end of the catheter.
However, in a separate embodiment, Al teaches (pg. 5, figs. 5a-c), in the same field of endeavor, a catheter comprising a soft tip (crown 503 formed of an elastic material, considered to be soft) that tapers toward a distal end of the catheter (fig. 5c), for the purpose of forming a protrusion that can contact the proximal cap of the CTO while significantly reducing the outer diameter of the outer elongated member (pg. 5).
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 crown of Al (as modified) to taper toward the distal end of the catheter, in order to provide a distinct protrusion for contacting the proximal cap of the CTO, based on the teachings of the separate embodiment of Al (pg. 5).
Regarding claim 20, Al discloses (pgs. 1-6; figs. 1-10) a method for treating an occlusion in a blood vessel (pgs. 4-5) comprising:
advancing a catheter (fig. 1) within the blood vessel to the occlusion (pgs. 4-6) such that at least one emitter assembly (includes conductive wires 206, 207 and hollow cover 214) of the catheter is positioned proximate the occlusion (makes contact with CTO, pg. 4), wherein the at least one emitter assembly comprises:
a first wire (206), a second wire (207), and a conductive sheath (cover 214) extending around the first wire and the second wire (covers distal end of 201, pg. 4, fig. 3a), and a fluid outlet port of the catheter (port of 212, pg. 4 describes lumens 211 and 212 serving as fluid inlet and outlet ports, such that 212 is considered to serve as the fluid outlet port); and
generating one or more shock waves by the at least one emitter assembly to treat the occlusion (pgs. 4-6).
However, Al fails to specifically disclose wherein the first wire extends through the fluid outlet port of the catheter.
Zhou teaches (paras. [0044]-[0047]; figs. 3-4), in the same field of endeavor, a catheter for treating occlusions in blood vessels (abstract) comprising a wire (172) extending through a lumen fluidly communicating with a balloon cavity (128 is capable of circulating fluid, paras. [0044]-[0047]), for the purpose of absorbing ultrasound energy so as to increase the transmission of ultrasound energy to a thrombosis, so that fluid can be rapidly heated upon the application of energy or circulated to cool the emitting element (paras. [0037]-[0038] and [0046]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Al such that the first wire extends through the fluid outlet port, in order to increase the transmission of energy to an occlusion, by rapidly heating fluid upon the application of energy or circulating fluid to cool the wires when desired, based on the teachings of Zhou (paras. [0037]-[0038] and [0046]). Note the combination would further consolidate the lumens and free up space within member 201.
Claim(s) 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Al in view of Zhou as applied to claim 1 above, and further in view of Genstler (US 2012/0289889 A1).
Regarding claim 11, Al (as modified) teaches the catheter of claim 1.
Al further discloses a sheath (cover 202) wrapped circumferentially around the tubular inner member (pg. 4, fig. 3a).
However, Al (as modified) fails to teach further comprising: the sheath being a reinforced wire sheath.
Genstler teaches (para. [0035]), in the same field of endeavor, a catheter (12) for treating occlusions in blood vessels (abstract, para. [0002]) comprising reinforced wire (nickel titanium or stainless steel wires placed along tubular body 12, para. [0035]), for the purpose of providing increased kink resistance and pushability through the patient’s vasculature to a treatment site (para. [0035]).
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 cover 202 of Al (as modified) to further include reinforced wire, therefore constituting a reinforced wire sheath wrapped circumferentially around 201 of Al, in order to provide increased kink resistance and pushability through the patient’s vasculature to a treatment site, based on the teachings of Genstler (para. [0035]).
Regarding claim 12, Al (as modified) teaches the catheter of claim 11. Al (as modified) further teaches wherein the reinforced wire sheath comprises at least one braided metal wire (para. [0035] of Genstler) encapsulated in a polymer (braiding incorporated into tubular body 12 of Genstler made of polymers, combination considered to further teach braiding encapsulated by polymer cover 202 of Al).
Claim(s) 18 is rejected under 35 U.S.C. 103 as being unpatentable over Al in view of Zhou as applied to claim 1 above, and further in view of Bonde (US 2012/0323254 A1).
Regarding claim 18, Al (as modified) teaches the catheter of claim 1.
However, Al (as modified) fails to teach wherein the conductive sheath is oval-shaped.
Bonde teaches (abstract, paras. [0049] and [0067]; fig. 7b), in the analogous art of the claimed invention, a catheter (712) which is oval-shaped (oblong lumen), for the purpose of introducing multiple tools/devices into a defined space through a single entry (para. [0049]).
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 shape of the sheath of Al (as modified) to be oval-shaped, in order to provide an oblong lumen with additional space for entry of more conductive fluid, or additional space to allow for larger or smaller gaps between the conductive wires and the sheath to be utilized dependent on the desired arcs generated between the conductive wires and the sheath, based on the suggestions and teachings of Bonde (para. [0049]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 2018/0360482 A1 to Nguyen, disclosing a device and method for generating forward directed shock waves.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIGID K BYRD whose telephone number is (571)272-7698. The examiner can normally be reached Mon-Fri 8:00-5:00.
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/BRIGID K BYRD/Examiner, Art Unit 3771
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