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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 8/26/25 and 9/23/25 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Objections
Claim 10 is objected to because of the following informalities: in line 2, “the lumen” should read --the aspiration lumen--. Appropriate correction is required.
Claim 20 is objected to because of the following informalities: in line 2, “the lumen” should read --the aspiration lumen--. Appropriate correction is required.
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 13 and 14 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.
Claim 13 recites the limitation "the console" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claim 14 is dependent on rejected claim 13, thus is also rendered indefinite.
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.
Claims 1-11, 13, 14, 19, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Pyro et al. (US 2021/0228274 A1) (“Pyro”) in view of Bhatta (5,152,768) and Nguyen et al. (US 2019/0388110 A1) (“Nguyen”).
Regarding claims 1-11, 13, and 14, Pyro discloses (Figure 6) a medical device capable of treating a thrombotic lesion (paragraph 0027), comprising: an elongate catheter (606) including a proximal end region, a distal end region, an aspiration lumen (609) and a wire lumen (housing 607a/607b) extending therein; a support shaft (604) coupled to the elongate catheter, wherein the support shaft includes a support lumen (618) and a distal end coupled to a reflector (612); a laser emitter (607a/607b) extending within a portion of the wire lumen with a distal end region positioned adjacent to the reflector; wherein the emitter is configured to discharge a beam (Ba/Bb) directed toward the distal end region of the elongate catheter (Ra/Rb). Pyro discloses (Figure 6) that the support lumen is in communication with the wire lumen, and wherein the laser emitter (607a/607b) extends within at least a portion of the support lumen. Pyro discloses (Figure 6) that the reflector (612) is spaced away from a distal end of the elongate catheter (606). Pyro discloses (Figure 6) that the reflector is parabolic-shaped and defines a concave surface (614) facing the distal end of the elongate catheter. Pyro discloses (Figure 6) that the emitter (607a/607b) is configured to be positioned adjacent to the concave surface (614) of the reflector (612). Pyro discloses that the emitter creates a positive pressure which engages the concave surface (614) and travels proximally toward the distal end of the elongate catheter (paragraphs 0024, 0025, 0068). Pyro discloses that the vacuum generated in the aspiration lumen (609) of the catheter (606) generates a negative pressure adjacent to the distal end of the catheter, and wherein the negative pressure is directed proximally into the aspiration lumen of the catheter (paragraphs 0030 and 0066). Pyro discloses (Figure 6) that the positive pressure and the negative pressure are configured to transport thrombus from the thrombotic lesion into the aspiration lumen of the catheter (paragraphs 0024, 0025, 0068). The positive pressure and the negative pressure disclosed by Pyro are capable of being generated at substantially the same time period (paragraphs 0024, 0025, 0068).
Pyro discloses a laser emitter instead of: an electrically conductive member extending within a portion of the wire lumen, and wherein the conductive member includes a distal end region positioned adjacent to the reflector; an emitter coupled to the distal end region of the conductive member; wherein the emitter is configured to discharge an electrical pulse directed toward the distal end region of the elongate catheter. Pyro fails to explicitly disclose the proximal end region of the catheter is coupled to a pump, and wherein the pump is configured to generate a vacuum within the aspiration lumen of the catheter, wherein the pump is configured to maintain the vacuum within the lumen of the catheter to aspirate the thrombus from a patient. Pyro fails to disclose the distal end of the electrically conductive member is coupled to a controller, and wherein the controller is coupled to the console, wherein the controller includes one or more actuators, and wherein the one or more actuators are configured to generate the electrical pulse, the vacuum within the catheter lumen, or both the electrical pulse and the vacuum within the catheter lumen.
In the same field of endeavor, Bhatta teaches that a pulsed laser source or a pulsed electrical voltage source can provide a pulse of energy to produce a rapid vapor expansion that causes a high-velocity jack-hammer type impact on a target deposit. Bhatta teaches (Figures 1-4) an electrically conductive member (40) and an emitter (36) coupled to the distal end region of the conductive member. Bhatta teaches that the emitter is configured to discharge an electrical pulse directed toward the distal end region of the elongate catheter (Column 3, lines 6-25).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to substitute an electrically conductive member and an emitter coupled to the distal end region of the conductive member, wherein the emitter is configured to discharge an electrical pulse directed toward the distal end region of the elongate catheter, as taught by Bhatta, for the laser emitter disclosed by Pyro. Substitution of one known element (pulsed electrical voltage via a conductor and emitter) for another element (pulsed laser source) providing the same function to yield predictable results (a rapid vapor expansion) would have been obvious to one of ordinary skill in the art at the time of the invention.
In the same field of endeavor, Nguyen teaches (Figures 1-6) a proximal end region of the catheter is coupled to a pump, and wherein the pump is configured to generate a vacuum within the aspiration lumen of the catheter, wherein the pump is configured to maintain the vacuum within the lumen of the catheter to aspirate the thrombus from a patient (paragraph 0039). Nguyen teaches (Figures 1-6) a distal end of an electrically conductive member (112) is coupled to a controller (510), and wherein the controller is coupled to the console (502), wherein the controller includes one or more actuators, and wherein the one or more actuators are configured to generate the electrical pulse (paragraphs 0034, 0039, 0042).
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 proximal end region of the catheter taught by Pyro in view of Bhatta to be coupled to the pump, wherein the pump is configured to generate a vacuum within the aspiration lumen of the catheter, and wherein the pump is configured to maintain the vacuum within the lumen of the catheter to aspirate the thrombus from a patient, as taught by Nguyen. This modification would provide rapid removal of debris during the procedure (Nguyen, paragraph 0038). It also would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify a distal end of the electrically conductive member taught by Pyro in view of Bhatta to be coupled to a controller, wherein the controller is coupled to a console, wherein the controller includes one or more actuators, and wherein the one or more actuators are configured to generate the electrical pulse, as further taught by Nguyen. These modifications would provide a control console that allows an operator to adjust various parameters during an operation (Nguyen, paragraphs 0034, 0039, 0042)
Regarding claim 19, Pyro discloses (Figure 6) a medical device system capable of treating a thrombotic lesion (paragraph 0027), comprising: an elongate catheter (606) including a proximal end region, a distal end region, an aspiration lumen (609) and a wire lumen (housing 607a, 607b) extending therein; a support shaft (604) coupled to the elongate catheter, wherein the support shaft includes a support lumen (618) and a distal end coupled to a reflector (612); a laser emitter (607a/607b) extending along the elongate catheter with a distal end region positioned adjacent to the reflector; wherein the emitter is configured to discharge a beam (Ba/Bb) directed toward the distal end region of the elongate catheter (Ra/Rb).
Pyro discloses a laser emitter instead of: an electrically conductive member extending along the elongate catheter, wherein the proximal end region is coupled to a controller; an emitter coupled to the distal end region of the conductive member; wherein the emitter is configured to discharge an electrical pulse directed toward the distal end region of the elongate catheter. Pyro fails to disclose a console including a pump and an arc discharge generator; the controller coupled to the console; wherein the proximal end region of the catheter is coupled to the console.
In the same field of endeavor, Bhatta teaches that a pulsed laser source or a pulsed electrical voltage source can provide a pulse of energy to produce a rapid vapor expansion that causes a high-velocity jack-hammer type impact on a target deposit. Bhatta teaches (Figures 1-4) an electrically conductive member (40) and an emitter (36) coupled to the distal end region of the conductive member. Bhatta teaches that the emitter is configured to discharge an electrical pulse directed toward the distal end region of the elongate catheter (Column 3, lines 6-25).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to substitute an electrically conductive member and an emitter coupled to the distal end region of the conductive member, wherein the emitter is configured to discharge an electrical pulse directed toward the distal end region of the elongate catheter, as taught by Bhatta, for the laser emitter disclosed by Pyro. Substitution of one known element (pulsed electrical voltage via a conductor and emitter) for another element (pulsed laser source) providing the same function to yield predictable results (a rapid vapor expansion) would have been obvious to one of ordinary skill in the art at the time of the invention.
In the same field of endeavor, Nguyen teaches (Figure 1-6) a console (502) including a pump (paragraph 0039) and an arc discharge generator (506); a controller (510) coupled to the console (Figure 5); wherein the proximal end region of the catheter (100) is coupled to the console (Figure 5). Nguyen teaches an electrically conductive member (112) extending along the elongate catheter, wherein the proximal end region of the catheter is coupled to a controller; an emitter (102) coupled to the distal end region of the conductive member (112); wherein the emitter is configured to discharge an electrical pulse directed toward the distal end region of the elongate catheter (paragraphs 0039 and 0042).
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 medical device system taught by Pyro in view of Bhatta to include a console including a pump and an arc discharge generator; a controller coupled to the console; wherein the proximal end region of the catheter is coupled to the console; and wherein the electrically conductive member extends along the elongate catheter and has a proximal region coupled to the controller, as taught by Nguyen. These modifications would provide a control console that allows an operator to adjust various parameters during an operation as well as providing aspiration and removal of debris (paragraphs 0034, 0039, 0041).
Regarding claim 20, Pyro as modified by Bhatta and Nguyen teaches that the electrical pulse creates a positive pressure which travels proximally toward the lumen of the catheter (Pyro, paragraphs 0024, 0025, 0068).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Pyro et al. (US 2021/0228274 A1) (“Pyro”) in view of Bhatta (5,152,768) and Nguyen et al. (US 2019/0388110 A1) (“Nguyen”) as applied to claim 10, and in further view of Brady et al. (US 2019/0239910 A1) (“Brady”).
Regarding claim 12, Pyro as modified by Bhatta and Nguyen teaches the invention substantially as claimed. However, the combined teaching fails to explicitly teach that the positive pressure and the negative pressure are generated in sequence.
In the same field of endeavor, Brady teaches (Figures 5A-5E) removing blood clots by applying pulsatile energy comprising a sequence of alternating forces through an aspiration lumen of a catheter. Brady teaches that the sequence of pulsatile forces has the effect of both deforming the clot in addition to aspirating the clot back through the catheter (paragraph 0016). Brady teaches this cyclical motion results in a symmetrical sinusoidal wave form of positive and negative pressure (paragraph 0034).
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 medical device taught by Pyro in view of Bhatta and Nguyen to generate positive and negative pressure in sequence, as taught by Brady. This modification would provide a sinusoidal waveform that facilitates deforming a clot as well as aspirating a clot back through the catheter (Brady, paragraphs 0016 and 0034).
Claims 15-18 are rejected under 35 U.S.C. 103 as being unpatentable over Tozzi (US 2019/0150961 A1) in view of Ruggio (US 5,476,450).
Regarding claim 15, Tozzi discloses (Figures 1-3) a medical device for treating a thrombotic lesion, comprising: an elongate catheter (20) including a proximal end region, a distal end region, and a wire lumen (Figure 2) extending therein; a support shaft (1) coupled to the elongate catheter (paragraph 0066), wherein the support shaft includes a support lumen and a distal end coupled to a first reflector (3) and a second reflector (3); an electrically conductive member (5) extending within a portion of the wire lumen, wherein the conductive member includes a first end region positioned adjacent to the first reflector and a second end region positioned adjacent to the second reflector; a first emitter (4) coupled to the first end region of the conductive member, the first emitter positioned adjacent to the first reflector (paragraph 0057); a second emitter (4) coupled to the second end region of the conductive member, the second emitter positioned adjacent to the second reflector (paragraph 0057); wherein the first emitter and the second emitter are configured to discharge an electrical pulse directed toward the distal end region of the elongate catheter (paragraph 0068).
Tozzi fails to disclose the elongate catheter including an aspiration lumen.
In the same field of endeavor, Ruggio teaches (Figures 6-15) an elongate catheter (240) with multiple lumens (244, 246). Ruggio teaches the elongate multi-lumen catheter includes an aspiration lumen (246).
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 elongate catheter disclosed by Tozzi to include an aspiration lumen, as taught by Ruggio. This modification would allow removal of residue from the thrombotic lesion (Column 17, lines 28-34).
Regarding claim 16, Tozzi as modified by Ruggio teaches (Tozzi, Figure 2) that the support lumen is in communication with the wire lumen (the support lumen of Tozzi is slidably disposed in the wire lumen, paragraph 0066), and wherein the electrically conductive member (5) extends within at least a portion of the support lumen (Tozzi, paragraph 0057).
Regarding claim 17, Tozzi as modified by Ruggio teaches (Tozzi, Figures 2 and 3) the first reflector (3) is spaced away from a distal end of the elongate catheter (paragraph 0066), and wherein the second reflector (3) is spaced away from the first reflector (Figure 3 shows the reflectors 3 are radially spaced apart from each other).
Regarding claim 18, Tozzi as modified by Ruggio teaches that the first emitter (4) and the second emitter (4) are each capable of discharging an electrical pulse at substantially the same time (paragraphs 0056-0058, 0068, 0075-0076, 0083).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTIAN D KNAUSS whose telephone number is (571)272-8641. The examiner can normally be reached M-F 12:30-8:30.
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/C.D.K/Examiner, Art Unit 3771
/BRIGID K BYRD/Examiner, Art Unit 3771
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