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 § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 14-18 and 19-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claims 13 and 19 recite “to soften and/or emulsify the occlusion” or “aspirate the softened and/or emulsified occlusion”, which involves a broad recitation (“soften or emulsify” and “softened or emulsified”) followed by a narrower statement of the range/limitation (“soften and emulsify” and “softened and emulsified”). The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. It is unclear whether the aspiration must be configured to soften and emulsify the occlusion, or whether it must be configured to only soften or emulsify the occlusion. It is recommended that the claim be amended to only recite the broader limitation (“soften or emulsify” and “softened or emulsified”). Should the Applicant also wish to claim the narrower recitation, it is recommended that it be included in a subsequent dependent claim separate from the broader recitation to properly define the scope.
Claims 15-18 and 20 each depend from claims 14 and 19, respectively, and therefore inherit the deficiencies as stated above.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claim 13 is rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Claim 13 recites “wherein the occlusion comprises a thrombus”. This limitation encompasses a human organism because it appears to positively recite the occlusion/thrombus of a patient. It is recommended that the claim be amended to recite the thrombus as the object of functional language instead by using “configured to” language, such as by reciting “wherein the thermal system is configured to remove a thrombus” to establish that the thrombus/occlusion itself is not being claimed.
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.
Claims 1-4, 6, 9-11, and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Constantz et al. (US PGPub 2002/0044907 A1).
With respect to claim 1, Constantz et al. discloses a thermal system for removing an occlusion from a blood vessel (abstract, see Fig. 4B), the thermal system comprising:
an irrigation catheter (40) comprising one or more apertures (44) at a distal portion (44 are located on a distal end of 24);
wherein the irrigation catheter (40) is configured to be navigated through a blood vessel to deliver a heated fluid to an occlusion to soften and/or emulsify the occlusion (see Fig. 4B and MPEP 2112.01, the catheter 40 is configured to deliver heated fluid to accomplish this).
Regarding claim 2, Constantz et al. further discloses an aspiration catheter (20 in Fig. 4B) configured to aspirate the softened and/or emulsified occlusion (see arrows in Fig. 4B, see also MPEP 2112.01).
Regarding claim 3, Constantz et al. further discloses wherein the irrigation catheter (40 in Fig. 4B) and the aspiration catheter (20) are configured to be concentrically positioned (see Fig. 4B, 40 is concentrically positioned within 20).
Regarding claim 4, Constantz et al. further discloses wherein the irrigation catheter (40 in Fig. 4B) is configured to be disposed inside the aspiration catheter (20).
Regarding claim 6, Constantz et al. further discloses wherein the one or more apertures (44 in Fig. 4B) of the irrigation catheter (40) are disposed through a peripheral wall of the irrigation catheter (see 44 in wall of 40).
Regarding claim 9, Constantz et al. further discloses a distal balloon (46 in Fig. 4B) configured to be inflated distal of the occlusion (see Fig. 4B with 46 inflated distal of occlusion 34).
Regarding claim 10, Constantz et al. further discloses a proximal balloon (24 in Fig. 4B) configured to be inflated proximal of the occlusion (see Fig. 4B with 24 inflated proximal of occlusion 34).
Regarding claim 11, Constantz et al. further discloses wherein the proximal balloon (24 in Fig. 4B) is disposed on an aspiration catheter (20 is an aspiration catheter).
Regarding claim 13, Constantz et al. further discloses wherein the occlusion comprises a thrombus (34 in Fig. 4B, PP [0049]: “one or both ends of the occlusion may be characterized by being primarily thrombotic material, e.g. a thrombus”).
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 5 is rejected under 35 U.S.C. 103 as being unpatentable over Constantz et al. (US PGPub 2002/0044907 A1).
Regarding claim 5, Constantz et al. fails to disclose wherein the aspiration catheter is configured to be disposed inside the irrigation catheter.
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the Constantz et al. disclosure such that the aspiration catheter is configured to be disposed inside the irrigation catheter. One of ordinary skill in the art would have been motivated to perform this modification as it would have been obvious to try, as there are a finite number of solutions (aspiration catheter within irrigation catheter, irrigation catheter within aspiration catheter, each catheter deployed side by side and not concentrically) that one of ordinary skill in the art could have explored with a reasonable expectation of success.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Constantz et al. (US PGPub 2002/0044907 A1) in view of Andrew et al. (US Patent No. 6,544,211 B1).
Regarding claim 7, Constantz et al. fails to disclose wherein the irrigation catheter comprises one or more heated elements to heat the heated fluid.
In the same field of tissue removal (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”) via a heating element (col. 3, lines 3-4: “The fluid source is heated by a heating element (not shown) that can be located within or outside of the handpiece 12”).
It would have been prima facie obvious for one of ordinary skil in the art before the effective filing date for one of ordinary skill in the art to have modified the Constantz et al. device to incorporate the teachings of Andrew et al. and include a heating element for heating the supplied fluid. 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 a similar method (the tissue removal method as disclosed by Solar 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 in the removal of thrombi within the vasculature (col. 4, lines 41-42: “The present method may also be used in such areas as… vascular atherectomy/thrombectomy…”). Furthermore, modifying the Constantz et al. device such that the heating element is located within the irrigation catheter would have been a simple rearrangement of parts (see MPEP 2144.04 VI. C., In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950)) since changing the location of the heated element would not modify the operation of the device as proposed.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Constantz et al. (US PGPub 2002/0044907 A1) in view of Kapur et al. (US PGPub 2013/0325003 A1).
Regarding claim 8, Constantz et al. fails to disclose a crossing element configured to be heated to facilitate penetrating the occlusion.
In the same field of clot removal (abstract), Kapur et al. teaches a device (see Fig. 1A) comprising a guidewire (proximal end of 122 in Fig. 4) including a crossing element (122 in Figs. 5A-B) configured to be heated to facilitate penetrating an occlusion (PP [0057]: “Communication between the electrode(s) 126 and the energy source 102 energizes the material removal element 122 by imparting the material removal element 122 with non-mechanical energy. It is envisioned that the energy source 102 may be capable of generating various types of non-mechanical energy suitable for the intended purpose of facilitating removal of the occlusion O (FIG. 1) including, but not being limited to, resistive heating, RF energy, microwave energy, ultrasonic energy, or the like”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the Constantz et al. device to incorporate the teachings of Kapur et al. and include the crossing element as taught. One of ordinary skill in the art would have been motivated to perform this modification as it is a simple substitution of guidewires (see guidewire lumen 28 in Fig. 2A of Constantz et al. which would be a lumen for wire 122 of Kapur et al.) that would have yielded predictable results, since the wire 122 of Kapur et al. is intended to provide an enhanced ability to cross total occlusions or order chronic occlusions (PP [0059]: “The smaller cross section of the wire making up the material removal element 122 at the debriding member 124 is better able to enter a total occlusion O and harder chronic occlusions”) which would enable deployment of the Constantz et al. device (PP [0055]: “In FIG. 4A, artery 36 is totally occluded by calcified vascular occlusion 32. Coaxial catheter assembly made up of total occlusion catheter insert 30 inside of aspiration catheter 20 is positioned proximal to one surface of occlusion 32, e.g. by advancement over a guidewire with imaging”).
Regarding claim 12, Constantz 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 clot removal (abstract), Kapur et al. teaches a device (see Fig. 1A) comprising a guidewire (proximal end of 122 in Fig. 4) including a crossing element (122 in Figs. 5A-B) configured to be heated to facilitate penetrating an occlusion (PP [0057]: “Communication between the electrode(s) 126 and the energy source 102 energizes the material removal element 122 by imparting the material removal element 122 with non-mechanical energy. It is envisioned that the energy source 102 may be capable of generating various types of non-mechanical energy suitable for the intended purpose of facilitating removal of the occlusion O (FIG. 1) including, but not being limited to, resistive heating, RF energy, microwave energy, ultrasonic energy, or the like”). Kapur et al. further teaches 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 (PP [0063]: “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”)
Claims 14-15 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Solar et al. (PGPub US 2015/0314111 A1) in view of Hochaeron (US PGPub 2014/0207060 A1).
With respect to claim 14, Solar et al. discloses a thermal system for removing an occlusion from a blood vessel (see Figs. 14A-B and abstract), the thermal system comprising:
a multi-lumen tube (320, see multiple lumens in Fig. 14B) comprising a proximal balloon (328) and an aspiration lumen (320, PP [0063]: “Thrombus 220 may then be aspirated into outer elongated element 320”), the proximal balloon (328) configured to be inflated proximally of an occlusion (see Fig. 17D with 328 inflated proximal of 202);
an irrigation lumen (320, PP [0046]: “Hub 330 includes an infusion port 340 for introducing a delivery substance such as a drug solution into delivery lumen 378 (i.e. outer elongated element lumen 321)”); and
a distal-balloon catheter (322) comprising a distal balloon (329) configured to be inflated distally of the occlusion (see Fig. 17D where 329 is distal to occlusion 202), the distal-balloon catheter (322) configured to be advanced through and distally out of the multi-lumen tube (320, see Figs. 14A-B);
wherein the irrigation lumen is configured to deliver heated fluid (see MPEP 2112.01, the irrigation lumen 321 is configured to deliver heated fluid) to the occlusion to soften and/or emulsify the occlusion (PP [0046]: “Hub 330 includes an infusion port 340 for introducing a delivery substance such as a drug solution into delivery lumen 378 (i.e. outer elongated element lumen 321)”); and
wherein the aspiration lumen is configured to aspirate the softened and/or emulsified occlusion (PP [0063]: “Thrombus 220 may then be aspirated into outer elongated element 320”).
However, Solar et al. fails to disclose an irrigation catheter configured to be advanced through and distally out of the multi-lumen tube to the occlusion configured to deliver heated fluid, since the Solar et al. device both aspirates and irrigates via catheter 320.
In the same field of occlusion devices for debris removal (see abstract and PP [0055]), Hochaeron teaches a system (120 in Fig. 7) comprising separate irrigation (132) and aspiration (134) catheters.
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the method of Solar et al. according to the teachings of Hochaeron to incorporate advancing a separate irrigation catheter extending through the multi-lumen tube to the occlusion to deliver fluid. One of ordinary skill in the art would have been motivated to perform this modification “to prevent a dead space” and provide overlap between aspiration and irrigation to optimize the procedure (see PP [0087] of Hochaeron).
Regarding claim 15, Solar et al. as modified by Hochaeron further discloses wherein the distal-balloon catheter (322 in Figs. 14A-B of Solar et al.) is advanced through the irrigation catheter in the aspiration lumen (the combination as proposed would yield a separate irrigation catheter through 320 through which 322 extends).
Regarding claim 18, Solar et al. as modified by Hochaeron further discloses a temperature sensor (Solar et al. PP [0069]: “In order to more closely monitor physiological parameters during a procedure, sensors 50 may be placed at or near exit port 24, shown schematically in FIGS. 1A and 1B. Sensors 50 can include one or several sensors, capable of measuring pressure, temperature, flow, or a combination thereof”) configured to sense a temperature of the heated fluid, where the thermal system is configured to adjust the temperature of the heated fluid based on the sensed temperature (PP [0051]: “Hub 330 may connect supply elongated element 20 and inner elongated element 322 to a control unit, as described hereinbelow with reference to FIG. 2”).
Claims 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Solar et al. (PGPub US 2015/0314111 A1) in view of Hochaeron (US PGPub 2014/0207060 A1), as applied to claim 14 above, and further in view of Kapur et al. (US PGPub 2013/0325003 A1).
Regarding claim 16, Solar et al. as modified by Hochaeron fails to disclose a heating element configured to penetrate the occlusion for crossover.
In the same field of clot removal (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 (PP [0057]: “Communication between the electrode(s) 126 and the energy source 102 energizes the material removal element 122 by imparting the material removal element 122 with non-mechanical energy. It is envisioned that the energy source 102 may be capable of generating various types of non-mechanical energy suitable for the intended purpose of facilitating removal of the occlusion O (FIG. 1) including, but not being limited to, resistive heating, RF energy, microwave energy, ultrasonic energy, or the like”).
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 of Solar et al., Hochaeron, and Andrew et al. to incorporate the teachings of Kapur et al. and include the heated element as taught. One of ordinary skill in the art would have been motivated to perform this modification as it is a simple substitution of guidewires (see 332 in Fig. 17D of Solar et al. which would be replaced with the wire 122 of Kapur et al.) that would have yielded predictable results, since the wire 122 of Kapur et al. is intended to provide an enhanced ability to cross total occlusions or order chronic occlusions (PP [0059]: “The smaller cross section of the wire making up the material removal element 122 at the debriding member 124 is better able to enter a total occlusion O and harder chronic occlusions”).
Regarding claim 17, Solar et al. as modified by Hochaeron and Kapur et al. further discloses wherein the heated element (122 in Figs. 5A-B) is configured to be advanced through and distally out of the distal-balloon catheter (322 in Fig. 14A of Solar et al., the combination as proposed would swap 332 in Fig. 17D with 122 of Kapur et al. such that the heated element 122 extends through and out of distal-balloon catheter 322).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Solar et al. (PGPub US 2015/0314111 A1) in view of Hochaeron (US PGPub 2014/0207060 A1) and Andrew et al. (US Patent No. 6,544,211 B1).
With respect to claim 19, Solar et al. discloses a method of applying heated fluid to an occlusion for removal (see PP [0037] and Figs. 14A-B), the method comprising:
proximally positioning a multi-lumen tube (320, see the multiple lumens in Fig. 14B) relative to an occlusion (see Fig. 17D with 220 positioned proximal to 202);
inflating a proximal balloon (328) of the multi-lumen tube (320);
advancing a distal-balloon catheter (322) through the multi-lumen tube (320) to position a distal balloon (329) distal of the occlusion (329 is distal of 202);
inflating the distal balloon (see Fig. 17E where 329 is inflated);
delivering fluid to the occlusion to soften and/or emulsify the occlusion (PP [0046]: “Hub 330 includes an infusion port 340 for introducing a delivery substance such as a drug solution into delivery lumen 378 (i.e. outer elongated element lumen 321)”); and
aspirating the softened and/or emulsified occlusion (PP [0063]: “Thrombus 220 may then be aspirated into outer elongated element 320”).
However, Solar et al. fails to disclose advancing an irrigation catheter through the multi-lumen tube to the occlusion, and further fails to disclose delivering heated fluid by way of the irrigation catheter, since the Solar et al. device both aspirates and irrigates via catheter 320.
In the same field of occlusion devices for debris removal (see abstract and PP [0055]), Hochaeron teaches a system (120 in Fig. 7) comprising separate irrigation (132) and aspiration (134) catheters.
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the method of Solar et al. according to the teachings of Hochaeron to incorporate advancing a separate irrigation catheter through the multi-lumen tube to the occlusion. One of ordinary skill in the art would have been motivated to perform this modification “to prevent a dead space” and provide overlap between aspiration and irrigation to optimize the procedure (see PP [0087] of Hochaeron).
However, Solar et al. as modified by Hochaeron further fails to disclose delivering heated fluid.
In the same field of tissue removal (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 further modified the combination of Solar et al. and Hochaeron to include the teachings of Andrew et al. and incorporate delivering heated fluid. 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 a similar method (the tissue removal method as disclosed by Solar 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 in the removal of thrombi within the vasculature (col. 4, lines 41-42: “The present method may also be used in such areas as… vascular atherectomy/thrombectomy…”).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Solar et al. (PGPub US 2015/0314111 A1) in view of Hochaeron (US PGPub 2014/0207060 A1) and 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, Solar et al. as modified by Hochaeron and Andrew et al. fails to disclose penetrating the occlusion with a heated element to facilitate crossover.
In the same field of clot removal (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 (PP [0057]: “Communication between the electrode(s) 126 and the energy source 102 energizes the material removal element 122 by imparting the material removal element 122 with non-mechanical energy. It is envisioned that the energy source 102 may be capable of generating various types of non-mechanical energy suitable for the intended purpose of facilitating removal of the occlusion O (FIG. 1) including, but not being limited to, resistive heating, RF energy, microwave energy, ultrasonic energy, or the like”).
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 of Solar et al., Hochaeron, and Andrew et al. to incorporate the teachings of Kapur et al. and include the heated element as taught. One of ordinary skill in the art would have been motivated to perform this modification as it is a simple substitution of guidewires (see 332 in Fig. 17D of Solar et al. which would be replaced with the wire 122 of Kapur et al.) that would have yielded predictable results, since the wire 122 of Kapur et al. is intended to provide an enhanced ability to cross total occlusions or order chronic occlusions (PP [0059]: “The smaller cross section of the wire making up the material removal element 122 at the debriding member 124 is better able to enter a total occlusion O and harder chronic occlusions”).
Conclusion
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.
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/BRIDGET E. RABAGLIA/Examiner, Art Unit 3771
/TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771