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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a) because they fail to show “an abrasive mass” as detailed in claim 11 and as described in the specification. Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 1, 6-7, 14, and 19-20 are objected to because of the following informalities:
In claim 1, line 5: “its longitudinal axis in the rotor lumen” should read “a longitudinal axis of the elongate rotor”.
In claim 6, line 3: “its longitudinal axis in the rotor lumen” should read “the longitudinal axis of the elongate rotor”.
In claim 7, line 3: “its longitudinal axis” should read “a longitudinal axis of the cutting tip”.
In claim 7, line 5: “its longitudinal axis in the rotor lumen” should read “a longitudinal axis of the shaftless screw auger”.
In claim 14, line 6: “its longitudinal axis in the rotor lumen” should read “a longitudinal axis of the elongate rotor”.
In claim 14, line 15: “its longitudinal axis in the rotor lumen” should read “the longitudinal axis of the elongate rotor”.
In claim 19, line 7: “its longitudinal axis in the rotor lumen” should read “a longitudinal axis of the elongate rotor”.
In claim 19, line 15: “its longitudinal axis in the rotor lumen” should read “the longitudinal axis of the elongate rotor”.
In claim 20 line 3: “its contact” should read “contact”.
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.
Regarding claims 1 and 14, the phrase "optionally" renders the claim indefinite because it is unclear whether the limitation following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Claims 2-13 are rejected for the same reasons as claim 1 by virtue of dependency on claim 1. Claims 15-18 are rejected for the same reasons as claim 14 by virtue of dependency on claim 14.
Claim Rejections - 35 USC § 102
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, 6-8, and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Evans et al. (US 2001/0031981).
Regarding claim 1, an invention relating to atherectomy devices, Evans discloses (Figs. 20-21 & 25) an atherectomy-angioplasty device (130) , comprising: a tubular body (161) including a rotor lumen [i.e. lumen of element 113] and an inflation lumen [i.e. lumen of element 161 or in element 161] (Par. 0095 & 0102); an elongate rotor (141) disposed in the rotor lumen (Par. 0036 & 0103); a plaque-debulking element (142) actuated by the elongate rotor when the elongate rotor is rotated around its longitudinal axis in the rotor lumen, the plaque-debulking element configured to debulk atherosclerotic or restenotic plaques in a blood-vessel lumen of a patient (Par. 0009, 0091, 0095); and an elongate balloon (159) over a distal portion of the tubular body, the elongate balloon fluidly connected to the inflation lumen for inflating or deflating the elongate balloon as desired (Par. 0102).
Regarding claim 6, Evans discloses the atherectomy-angioplasty device of claim 1. Evans further discloses (Fig. 21) wherein the elongate rotor approximates a shaftless screw auger (141’) that creates a vacuum for aspirating atherosclerotic debris into the rotor lumen when the shaftless screw auger is rotated around its longitudinal axis in the rotor lumen (Par. 0091, 0095, 0103).
Regarding claim 7, Evans discloses the atherectomy-angioplasty device of claim 6. Evans further discloses (Fig. 21) wherein the plaque-debulking element is a rotatable cutting tip (142) coupled to the tubular body, the cutting tip coupled to the shaftless screw auger such that the cutting tip rotates around its longitudinal axis for cutting atherosclerotic or restenotic plaques away from the blood-vessel lumen of the patient when the shaftless screw auger is rotated around its longitudinal axis in the rotor lumen (Par. 0036, 0091, 0095, 0103).
Regarding claim 8, Evans discloses the atherectomy-angioplasty device of claim 7. Evans further discloses wherein the cutting tip includes at least one side aperture (see annotated figure below) in fluid communication with the rotor lumen, the side aperture allowing the atherosclerotic debris to be aspirated into the rotor lumen for extracorporeal collection of the atherosclerotic debris (Par. 0091, 0095, 0102-0103).
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Regarding claim 10, Evans discloses the atherectomy-angioplasty device of claim 1. Evans further discloses wherein the elongate rotor approximates a coiled-spring cable (Par. 0095).
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 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Evans et al. (US 2001/0031981) as applied to claim 10 above, and further in view of Piippo Svendsen et al. (US 2020/0214736) [i.e. Piippo].
Regarding claim 11, Evans discloses the atherectomy-angioplasty device of claim 10. However, Evans fails to disclose wherein the plaque-debulking element is an abrasive mass in a distal portion of the coiled-spring cable that orbits around a longitudinal axis of the coiled-spring cable for abrading atherosclerotic or restenotic plaques away from the blood-vessel lumen of the patient when the coiled-spring cable is rotated around its longitudinal axis in the rotor lumen.
In the same field of endeavor, which is atherectomy devices, Piippo discloses wherein a plaque-debulking element is an abrasive mass (138) in a distal portion of a coiled-spring cable (136; Par. 0039) that orbits around a longitudinal axis (139) of the coiled-spring cable for abrading atherosclerotic or restenotic plaques away from the blood-vessel lumen of the patient when the coiled-spring cable is rotated around its longitudinal axis in the rotor lumen (Par. 0037-0038).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Evans to have wherein the plaque-debulking element is an abrasive mass in a distal portion of the coiled-spring cable that orbits around a longitudinal axis of the coiled-spring cable for abrading atherosclerotic or restenotic plaques away from the blood-vessel lumen of the patient when the coiled-spring cable is rotated around its longitudinal axis in the rotor lumen. Doing so would remove or reduce stenotic lesions in blood vessels (Par. 0006), as taught by Piippo.
Regarding claim 12, Evans, as modified by Piippo, further discloses wherein the abrasive mass includes an abrasive band around a bump in cable diameter of the coiled-spring cable [i.e. burr coated with abrasive media such as diamond grit, see Piippo paragraph 0045].
Regarding claim 13, Evans, as modified by Piippo, further discloses the atherectomy-angioplasty device of claim 10. Evans further discloses (Figs. 18F & 22) wherein an axial channel (115) through the coiled-spring cable provides a guidewire lumen for a guidewire (Par. 0097-0098).
Claims 1 is rejected under 35 U.S.C. 103 as being unpatentable over Straub et al. (US 5,873,882) in view of Piippo Svendsen et al. (US 2020/0214736) [i.e. Piippo].
Regarding claim 1, an invention relating to atherectomy devices, Straub discloses (Figs. 1-2) an atherectomy-angioplasty device (12, 20, 24), comprising: a tubular body (22) including a rotor lumen [i.e. space occupied by elements 24 & 32] (Fig. 7); an elongate rotor (32) disposed in the rotor lumen (Fig. 7); a plaque-debulking element (14 & 16; Col. 3, lines 19-23) actuated by the elongate rotor when the elongate rotor is rotated around its longitudinal axis in the rotor lumen, the plaque-debulking element configured to debulk atherosclerotic or restenotic plaques in a blood-vessel lumen of a patient (Col. 3, lines 23-25 & Col. 4, lines 1-49). However, Straub fails to disclose the tubular body including an inflation lumen; and an elongate balloon over a distal portion of the tubular body, the elongate balloon fluidly connected to the inflation lumen for inflating or deflating the elongate balloon as desired, optionally, for angioplasty therewith.
In the same field of endeavor, which is atherectomy devices, Piippo teaches (Fig. 2) a tubular body (132) including an inflation lumen (Par. 0035); and an elongate balloon (134) over a distal portion of the tubular body, the elongate balloon fluidly connected to the inflation lumen for inflating or deflating the elongate balloon as desired, optionally, for angioplasty therewith (Par. 0035 & 0057).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Straub to have the tubular body including an inflation lumen; and an elongate balloon over a distal portion of the tubular body, the elongate balloon fluidly connected to the inflation lumen for inflating or deflating the elongate balloon as desired, optionally, for angioplasty therewith. Doing so would stabilize the drive shaft assembly in the vessel during the rotational atherectomy procedure (Par. 0035) and would provide a means of angioplasty (Par. 0057), as taught by Piippo.
Claims 6-10 are rejected under 35 U.S.C. 103 as being unpatentable over Straub et al. (US 5,873,882), in view of Piippo Svendsen et al. (US 2020/0214736) [i.e. Piippo], as applied to claim 1 above, and in the alternative and further in view of Straub (US 2007/0219484) [i.e. Straub’484].
Regarding claim 6, Straub, as modified by Piippo, discloses the atherectomy-angioplasty device of claim 1. Straub further discloses (Fig. 2) wherein the elongate rotor approximates a shaftless screw auger (32) that creates a vacuum for aspirating atherosclerotic debris into the rotor lumen when the shaftless screw auger is rotated around its longitudinal axis in the rotor lumen (Col. 4, lines 1-8).
In the alternative and in the analogous art of atherectomy device, Straub’484 teaches (Fig. 3) an elongate rotor approximates a shaftless screw auger (13) that creates a vacuum for aspirating atherosclerotic debris into a rotor lumen (see annotated figure below) when the shaftless screw auger is rotated around its longitudinal axis in the rotor lumen (Par. 0074).
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Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Straub, in view of Piippo, to have wherein the elongate rotor approximates a shaftless screw auger that creates a vacuum for aspirating atherosclerotic debris into the rotor lumen when the shaftless screw auger is rotated around its longitudinal axis in the rotor lumen. Doing so would suck removable material from hollow bodies, in particular of thrombi and emboli from human blood vessels (Abstract & Par. 0074), as taught by Straub’484.
Regarding claim 7, Straub, as modified by Piippo and Straub’484 in the alternative, discloses the atherectomy-angioplasty device of claim 6. Straub further discloses (Fig. 2) wherein the plaque-debulking element is a rotatable cutting tip (14 & 16; Col. 3, lines 19-23) coupled to the tubular body, the cutting tip coupled to the shaftless screw auger such that the cutting tip rotates around its longitudinal axis for cutting atherosclerotic or restenotic plaques away from the blood-vessel lumen of the patient when the shaftless screw auger is rotated around its longitudinal axis in the rotor lumen (Col. 3, lines 19-30 & Col. 4, lines 1-8).
Regarding claim 8, Straub, as modified by Piippo and Straub’484 in the alternative, discloses the atherectomy-angioplasty device of claim 7. Straub further discloses (Fig. 2) wherein the cutting tip includes at least one side aperture (14b-c) in fluid communication with the rotor lumen, the side aperture allowing the atherosclerotic debris to be aspirated into the rotor lumen for extracorporeal collection of the atherosclerotic debris (Col. 2, lines 12-15 & Col. 4, lines 9-30).
Regarding claim 9, Straub, as modified by Piippo and Straub’484 in the alternative, discloses the atherectomy-angioplasty device of claim 6. Straub further discloses wherein an absence of a shaft in the shaftless screw auger provides a guidewire lumen for a guidewire (Col. 4, lines 3-4).
Regarding claim 10, Straub, as modified by Piippo and Straub’484 in the alternative, discloses the atherectomy-angioplasty device of claim 1. Straub further discloses wherein the elongate rotor approximates a coiled-spring cable (Col. 4, lines 1-3).
Claims 2-4 are rejected under 35 U.S.C. 103 as being unpatentable over Straub et al. (US 5,873,882), in view of Piippo Svendsen et al. (US 2020/0214736) [i.e. Piippo], as applied to claim 1 above, and in the alternative and further in view of Sampognaro et al. (US 2011/0172598).
Regarding claim 2, Straub, as modified by Piippo, discloses wherein the elongate balloon is compactly folded in a ready-to-deploy state of the atherectomy-angioplasty device [i.e. a deflated low-profile configuration] (Par. 0056).
In the alternative and in the analogous art of atherectomy device, Sampognaro teaches wherein an elongate balloon is compactly folded in a ready-to-deploy state of an atherectomy-angioplasty device (Par. 0024).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Straub, in view of Piippo, to have the elongate balloon is compactly folded in a ready-to-deploy state of the atherectomy-angioplasty device, as taught by Sampognaro. Piippo discloses the inflatable member is configured in its deflated, low-profiled configuration during the advancing (Par. 0056), thus Sampognaro’s balloon would have provided Piippo with an elongate balloon that is compactly folded in a ready-to-deploy state of an atherectomy-angioplasty device.
Regarding claim 3, Straub, as modified by Piippo and Sampognaro in the alternative, discloses further comprising an expandable stent over the elongate balloon in the ready-to-deploy state of the atherectomy-angioplasty device [i.e. stent can placed at lesion by inflatable member, see Piippo paragraph 0057].
Regarding claim 4, Straub, as modified by Piippo and Sampognaro in the alternative, discloses further comprising a retractable sheath over the elongate balloon in the ready-to-deploy state of the atherectomy-angioplasty device [i.e. introducer sheath, see Piippo paragraph 0056].
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Straub et al. (US 5,873,882), in view of Piippo Svendsen et al. (US 2020/0214736) [i.e. Piippo] and Sampognaro et al. (US 2011/0172598) in the alternative, as applied to claim 4 above, and in the alternative and further in view of McCaffrey et al. (US 2020/0129196).
Regarding claim 5, Straub, as modified by Piippo and Sampognaro in the alternative, discloses the atherectomy-angioplasty device of claim 4. However, the combination fails to disclose wherein the elongate balloon includes a coating of an antiproliferative drug on an external surface of the elongate balloon, the retractable sheath protecting the coating prior to retracting the retractable sheath and inflating the elongate balloon for angioplasty therewith.
In the same field of endeavor, which is atherectomy, McCaffrey teaches wherein an elongate balloon [i.e. treatment balloon] includes a coating of an antiproliferative drug on an external surface of the elongate balloon (Par. 0181)
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Straub, in view of Piippo and Sampognaro in the alternative, to have wherein the elongate balloon includes a coating of an antiproliferative drug on an external surface of the elongate balloon, the retractable sheath protecting the coating prior to retracting the retractable sheath and inflating the elongate balloon for angioplasty therewith [Note, given Piippo’s teachings of the retractable sheath obviously the retractable sheath protecting the coating prior to retracting the retractable sheath and inflating the elongate balloon for angioplasty therewith]. Doing so would help prevent restenosis of the vessel or otherwise treat the vessel or lesion (Par. 0181), as taught by McCaffrey.
Claims 14 and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Straub et al. (US 5,873,882) in view of Piippo Svendsen et al. (US 2020/0214736) [i.e. Piippo].
Regarding claim 14, an invention relating to atherectomy devices, Straub discloses (Figs. 1-2) an atherectomy-angioplasty system (12, 20, 24), comprising: atherectomy-angioplasty device including: a tubular body (22) including a rotor lumen [i.e. space occupied by elements 24 & 32] (Fig. 7); an elongate rotor (32) disposed in the rotor lumen (Fig. 7); a plaque-debulking element (14 & 16; Col. 3, lines 19-23) actuated by the elongate rotor when the elongate rotor is rotated around its longitudinal axis in the rotor lumen, the plaque-debulking element configured to debulk atherosclerotic or restenotic plaques in a blood-vessel lumen of a patient (Col. 3, lines 23-25 & Col. 4, lines 1-49); and a drive unit (20) operably connected to the atherectomy-angioplasty device, the drive unit including a drive mechanism configured to rotate the elongate rotor around its longitudinal axis in the rotor lumen of the atherectomy-angioplasty device (Col. 3, lines 19-39 & 53-61).
In the same field of endeavor, which is atherectomy devices, Piippo teaches (Fig. 2) a tubular body (132) including an inflation lumen (Par. 0035); and an elongate balloon (134) over a distal portion of the tubular body, the elongate balloon fluidly connected to the inflation lumen for inflating or deflating the elongate balloon as desired, optionally, for angioplasty therewith (Par. 0035 & 0057).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Straub to have a tubular body including an inflation lumen; and an elongate balloon over a distal portion of the tubular body, the elongate balloon fluidly connected to the inflation lumen for inflating or deflating the elongate balloon as desired, optionally, for angioplasty therewith. Doing so would stabilize the drive shaft assembly in the vessel during the rotational atherectomy procedure (Par. 0035) and would provide a means of angioplasty (Par. 0057), as taught by Piippo.
Regarding claim 17, Straub, as modified by Piippo, discloses the atherectomy-angioplasty system of claim 14. Straub discloses (Fig. 1) further comprising a collection unit (28) fluidly connected to the rotor lumen of the atherectomy-angioplasty device, the collection unit configured for collecting atherosclerotic debris aspirated into the rotor lumen (Abstract & Col. 3, lines 28-30 and 55-64).
Regarding claim 18, Straub, as modified by Piippo, discloses the atherectomy-angioplasty system of claim 14. Straub discloses further comprising: a guidewire (24) configured for advancing the atherectomy-angioplasty device over the guidewire such that the plaque-debulking element is adjacent the atherosclerotic or restenotic plaques in the blood-vessel lumen of the patient (Col. 3, lines 48-53). Straub, as modified by Piippo, discloses a fluid-delivery device configured for inflating or deflating the elongate balloon via the inflation lumen with a fluid [i.e. source of saline, see Piippo paragraphs 0035].
Claim 15 rejected under 35 U.S.C. 103 as being unpatentable over Straub et al. (US 5,873,882), in view of Piippo Svendsen et al. (US 2020/0214736) [i.e. Piippo], as applied to claim 14 above, and in the alternative and further in view of Sampognaro et al. (US 2011/0172598).
Regarding claim 15, Straub, as modified by Piippo, further discloses the atherectomy-angioplasty device further comprising an expandable stent over a compactly folded elongate balloon in a ready-to-deploy state of the atherectomy-angioplasty device [i.e. stent can placed at lesion by inflatable member, see Piippo paragraph 0057].
In the alternative and in the analogous art of atherectomy device, Sampognaro teaches wherein an elongate balloon is compactly folded in a ready-to-deploy state of an atherectomy-angioplasty device (Par. 0024).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Straub, in view of Piippo, to have the elongate balloon is compactly folded in a ready-to-deploy state of the atherectomy-angioplasty device, as taught by Sampognaro. Piippo discloses the inflatable member is configured in its deflated, low-profiled configuration during the advancing (Par. 0056), thus Sampognaro’s balloon would have provided Piippo with an elongate balloon that is compactly folded in a ready-to-deploy state of an atherectomy-angioplasty device.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Straub et al. (US 5,873,882), in view of Piippo Svendsen et al. (US 2020/0214736) [i.e. Piippo], as applied to claim 14 above, and in the alternative and further in view of McCaffrey et al. (US 2020/0129196).
Regarding claim 16, Straub, as modified by Piippo, discloses the atherectomy-angioplasty system of claim 14. Straub fails to further disclose wherein the elongate balloon includes a coating of an antiproliferative drug on an external surface of the elongate balloon.
In the same field of endeavor, which is atherectomy, McCaffrey teaches wherein an elongate balloon [i.e. treatment balloon] includes a coating of an antiproliferative drug on an external surface of the elongate balloon (Par. 0181)
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Straub, in view of Piippo, to have wherein the elongate balloon includes a coating of an antiproliferative drug on an external surface of the elongate balloon, the retractable sheath protecting the coating prior to retracting the retractable sheath and inflating the elongate balloon for angioplasty therewith [Note, given Piippo’s teachings of the retractable sheath obviously the retractable sheath protecting the coating prior to retracting the retractable sheath and inflating the elongate balloon for angioplasty therewith]. Doing so would help prevent restenosis of the vessel or otherwise treat the vessel or lesion (Par. 0181), as taught by McCaffrey.
Claims 19-22 are rejected under 35 U.S.C. 103 as being unpatentable over Straub et al. (US 5,873,882) in view of Piippo Svendsen et al. (US 2020/0214736) [i.e. Piippo].
Regarding claim 19, an invention relating to atherectomy devices, Straub discloses (Figs. 1-2) a method of an atherectomy-angioplasty system (Abstract), comprising: obtaining an atherectomy-angioplasty device (12, 20, 24), the atherectomy-angioplasty device including: a tubular body (22) including a rotor lumen [i.e. space occupied by elements 24 & 32] (Fig. 7); an elongate rotor (32) disposed in the rotor lumen (Fig. 7); a plaque-debulking element (14 & 16; Col. 3, lines 19-23) actuated by the elongate rotor when the elongate rotor is rotated around its longitudinal axis in the rotor lumen; advancing the plaque-debulking element to a treatment area within a blood-vessel lumen of a patient (Col. 3, lines 23-25, 48-67 & Col. 4, lines 1-49); driving a drive unit operably connected to the atherectomy-angioplasty device, the drive unit (20) including a drive mechanism configured to rotate the elongate rotor around its longitudinal axis in the rotor lumen of the atherectomy-angioplasty device to debulk an atherosclerotic or restenotic plaque in the treatment area (Col. 3, lines 19-39, 53-61 & Col. 4, lines 4-8). However, Straub fails to disclose a tubular body including an inflation lumen; and an elongate balloon over a distal portion of the tubular body, the elongate balloon fluidly connected to the inflation lumen for inflating or deflating the elongate balloon; and inflating the elongate balloon via the inflation lumen with fluid from a fluid-delivery device such that the elongate balloon is at least in contact with a blood-vessel wall in the treatment area.
In the same field of endeavor, which is atherectomy devices, Piippo teaches (Fig. 2) a tubular body (132) including an inflation lumen (Par. 0035); and an elongate balloon (134) over a distal portion of the tubular body, the elongate balloon fluidly connected to the inflation lumen for inflating or deflating the elongate balloon; and inflating the elongate balloon via the inflation lumen with fluid from a fluid-delivery device such that the elongate balloon is at least in contact with a blood-vessel wall in the treatment area (Par. 0035 & 0057).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Straub to have a tubular body including an inflation lumen; and an elongate balloon over a distal portion of the tubular body, the elongate balloon fluidly connected to the inflation lumen for inflating or deflating the elongate balloon; and inflating the elongate balloon via the inflation lumen with fluid from a fluid-delivery device such that the elongate balloon is at least in contact with a blood-vessel wall in the treatment area. Doing so would stabilize the drive shaft assembly in the vessel during the rotational atherectomy procedure (Par. 0035) and would provide a means of angioplasty (Par. 0057), as taught by Piippo.
Regarding claim 20, Straub, as modified by Piippo, discloses further wherein inflating the elongate balloon is performed before driving the drive unit to debulk the atherosclerotic or restenotic plaque in the blood-vessel lumen of the patient, the elongate balloon blocking blood flow by way of its contact with the blood-vessel wall and, thereby, preventing dispersion of atherosclerotic debris from the treatment area [see Piippo paragraph 0035].
Regarding claim 21, Straub, as modified by Piippo, discloses further wherein inflating the elongate balloon is performed after driving the drive unit to debulk the atherosclerotic or restenotic plaque in the blood-vessel lumen of the patient, the elongate balloon effectuating angioplasty in the treatment area [see Piippo paragraph 0057].
Regarding claim 22, Straub, as modified by Piippo, discloses the method of claim 19. Straub (Fig. 1) discloses further comprising collecting atherosclerotic debris from the rotor lumen of the atherectomy-angioplasty device with a collection unit (28) fluidly connected to the rotor lumen (Abstract & Col. 3, lines 28-30 and 55-64).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Examiner Chima Igboko whose telephone number is (571)272-8422. The examiner can normally be reached on Monday-Friday 9:00am-6:00pm.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Jackie Ho, at (571) 272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/C.U.I/ Examiner, Art Unit 3771
/ASHLEY L FISHBACK/Primary Examiner, Art Unit 3771 June 1, 2026
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