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 1, 3-6, 9, 11, 12 and 16 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.
The “~” in claims 5, 6, 11, and 12 is a relative symbol which renders the claim indefinite. The term “~” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
The claims recite numerical ranges using the tilde symbol (“~”), e.g., “2 ~ 5”, “10 ~ 50 mm2”, “10 µm ~ 80 µm”, “0.02 ~ 0.2 mm”, and “2 ~ 10 times.”
The use of “~” to express approximation renders the claims indefinite because a person of ordinary skill in the art cannot determine the metes and bounds of the claimed invention with reasonable certainty. The specification does not provide a clear standard for determining the degree of approximation intended by the tilde. See MPEP §2173.05(b).
The following limitations lack antecedent basis:
“the aperture of the first holes” / “the aperture of the second holes” (claims 1, 6).
“the coverage rate” (claims 3, 16).
“one second hole,” “one first hole,” “one or more first holes,” and “two or more first holes” (claims 4, 5). It is unclear whether these refer to the previously recited plurality of first/second holes or to different structures.
“the drug solution” (claims 6, 9)
“the axis line of the first hole,” “the axis line of the second hole,” and “the axis line of the covering member” (claims 5, 11, 15)
“The width of the covering elements” and “the thickness of the covering elements” (claims 11, 12)
Applicant is required to review the entire claim set and correct all antecedent basis, clarity, and typographical errors.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-17 are rejected under 35 U.S.C. 103 as being unpatentable over (US Patent No. 11,559,668), hereinafter, Palmaz, in view of (US Patent No. 6,623,452), hereinafter, Chien.
Regarding claim 1, Palmaz discloses a vascular stenosis treatment apparatus, comprising: a treatment assembly (drug-eluting balloon assembly 10 in figs. 1A-1B; col. 6, lines 33-59) having:
a balloon (balloon 18 in figs. 1A-1B; col. 6, lines 33-36), and the balloon having an unexpanded state (balloon assembly 10 with balloon 18 in its unexpanded diametric state in figs. 1A and 3A; col. 6, lines 39-40) and an expanded state (balloon assembly 10 with balloon 18 in its expanded diametric state in figs. 1B and 3B; col. 6, lines 41-42); and
a covering member (sleeve 12 in figs. 1A-1B; col. 6, lines 34-35), the covering member covering the outside of the balloon and expanding with the expansion of the balloon (sleeve 12 is mounted on underlying drug-eluting balloon catheter 16 and has a proximal end 11 and a distal end 13 that are joined to the drug-eluting balloon catheter 16 to couple the sleeve 12 to the drug-eluting balloon catheter 16 in figs. 1A-1B; col. 6, lines 35-39), the covering member having a plurality of second holes (a plurality of slits 14 are formed in the sleeve 12 and pass through wall surfaces thereof. Each of the plurality of slits 14 are elongate along a longitudinal axis of the sleeve 12 and communicate between a luminal surface of the sleeve 12 and an abluminal surface of the sleeve 12. The plurality of slits 14 are arrayed in a pattern along an intermediate section 17 of the sleeve 12; col. 6, lines 42-59),
Palmaz does not, however, disclose that the wall of the balloon is provided with a plurality of first holes for liquid to pass through and when the balloon is in the expanded state, that the aperture of the first holes is smaller than the aperture of the second holes.
Chien teaches that the wall of the balloon is provided with a plurality of first holes for liquid to pass through (Chien: highly compliant balloon 14 includes a plurality of infusion holes 15 which facilitate the delivery of drugs and other fluids to a specific site in a patient's vascular system in figs. 1A-1B; col. 2, lines 45-47) and that when the balloon is in the expanded state, the aperture of the first holes is smaller than the aperture of the second holes (Chien: size of the infusion holes 15 increases as the balloon 14 is inflated; col. 3, lines 31-32; size and number of the infusion holes 15 may be selected to allow the balloon 14 to inflate up to a prescribed diameter and to obtain the desired drug infusion rate; col. 3, lines 33-42; Chien supplies first holes that enlarge upon expansion; Palmaz supplies second holes (slits) that open significantly on expansion and produces the claimed size relationship as a result).
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 drug-eluting balloon of Palmaz to include a plurality of first holes in the balloon wall for liquid to pass through, as taught by Chien, in order to enable active fluid delivery through the balloon wall while retaining the protective, focused-release, and cutting benefits of the expandable outer sleeve of Palmaz.
Regarding claim 2, modified Palmaz discloses the vascular stenosis treatment apparatus according to claim 1, wherein, when the balloon transitions from the unexpanded state (balloon assembly 10 with balloon 18 in its unexpanded diametric state in figs. 1A and 3A; col. 6, lines 39-40) to the expanded state (balloon assembly 10 with balloon 18 in its expanded diametric state in figs. 1B and 3B; col. 6, lines 41-42), both the first holes on the balloon (Chien: highly compliant balloon 14 includes a plurality of infusion holes 15 which facilitate the delivery of drugs and other fluids to a specific site in a patient's vascular system in figs. 1A-1B; col. 2, lines 45-47) and the second holes on the covering member (a plurality of slits 14 are formed in the sleeve 12 and pass through wall surfaces thereof. Each of the plurality of slits 14 are elongate along a longitudinal axis of the sleeve 12 and communicate between a luminal surface of the sleeve 12 and an abluminal surface of the sleeve 12. The plurality of slits 14 are arrayed in a pattern along an intermediate section 17 of the sleeve 12; col. 6, lines 42-59) become larger, and when the balloon is in the expanded state, the degree of enlargement of the second holes is greater than that of the first holes (Chien: size of the infusion holes 15 increases as the balloon 14 is inflated; col. 3, lines 31-32; size and number of the infusion holes 15 may be selected to allow the balloon 14 to inflate up to a prescribed diameter and to obtain the desired drug infusion rate; col. 3, lines 33-42; Chien supplies first holes that enlarge upon expansion; Palmaz supplies second holes (slits) that open significantly on expansion and produces the claimed size relationship as a result).
Regarding claim 3, modified Palmaz discloses the vascular stenosis treatment apparatus according to claim 1 wherein, the coverage rate of the peripheral surface of the balloon by the covering member in the unexpanded state (balloon assembly 10 with balloon 18 in its unexpanded diametric state in figs. 1A and 3A; col. 6, lines 39-40) is greater than that of the peripheral surface of the balloon by the covering member in the expanded state (sleeve 12 is diametrically expandable with a plurality of elongate slits in figs. 1A-1B and 3A-3B; the unexpanded state in figs. 1A and 3A show the slits closed or of minimal width so the sleeve covers a high percentage of the underlying balloon catheter 16; in the expanded state in figs. 1B and 3B, the slits open significantly, thereby decreasing the coverage rate of the balloon surface); and/or,
in the expanded state and/or during the process of moving from the unexpanded state to the expanded state, the balloon and the covering member are attached to each other (sleeve 12 is mounted on underlying drug-eluting balloon catheter 16 and has a proximal end 11 and a distal end 13 that are joined to the drug-eluting balloon catheter 16 to couple the sleeve 12 to the drug-eluting balloon catheter 16 in figs. 1A-1B; col. 6, lines 35-39).
Regarding claim 4, modified Palmaz discloses the vascular stenosis treatment apparatus according to claim 1, wherein, in the expanded state (balloon assembly 10 with balloon 18 in its expanded diametric state in figs. 1B and 3B; col. 6, lines 41-42), the position of the plurality of first holes corresponds to the position of the plurality of second holes (Chien: infusion holes 15 shown in figs. 1A-1B correspond to slits 14 formed on sleeve 12 of Palmaz shown in figs. 1A-1B when combined), such that a plurality of relatively independent drug delivery spaces are formed between the balloon and the covering member (slits 14 open upon expansion to create open spaces for drug delivery between the land regions 15/35 in figs. 1B and 3b); and/or, in the unexpanded state (balloon assembly 10 with balloon 18 in its unexpanded diametric state in figs. 1A and 3A; col. 6, lines 39-40), the position of the first holes corresponds to the position of the second holes; and/or, one second hole is provided corresponding to one or more first holes (infusion holes 15 of Chien shown in figs. 1A-1B correspond to slits 14 formed on sleeve 12 of Palmaz shown in figs. 1A-1B when combined).
Regarding claim 5, modified Palmaz discloses the vascular stenosis treatment apparatus according to claim 4 comprising a second hole.
Modified Palmaz fails, however, to disclose that when one second hole is provided corresponding to one first hole, the axis line of the first hole coincides with the axis line of the second hole or when one second hole is provided corresponding to two or more first holes, the two or more first holes are uniformly distributed within the range of the second hole; and/or one second hole is provided corresponding to 2 ~ 5 first holes.
Chien teaches a corresponding first hole. Combined with the device of Palmaz, the axis line of the first hole coincides with the axis line of the second hole or when one second hole is provided corresponding to two or more first holes, the two or more first holes are uniformly distributed within the range of the second hole; and/or one second hole is provided corresponding to 2 ~ 5 first holes (Chien: infusion holes 15 are uniformly distributed about the highly compliant balloon 14 as illustrated in figs. 1A-1B and can be geometrically placed as an array under a larger opening; col. 3, lines 21-32; Palmaz discloses the relatively larger opening having slits 14; col. 6, lines 42-59).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to arrange the first holes of the modified Palmaz device so that one second hole corresponds to a small plurality (2-5) of first holes that are substantially uniformly distributed within the area of the second hole, as a matter of routine optimization of hole density and spacing to achieve controlled drug delivery through the opened slits (as shown in the annotated figure below).
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Regarding claim 6, modified Palmaz discloses the vascular stenosis treatment apparatus according to claim 1, wherein, the number and aperture of the first holes are provided so that, in the expanded state (balloon assembly 10 with balloon 18 in its expanded diametric state in figs. 1B and 3B; col. 6, lines 41-42), the drug solution can be sprayed out from the first holes (Chien: size and number of the infusion holes 15 may be selected to allow the balloon 14 to inflate up to a prescribed diameter and to obtain the desired drug infusion rate; col. 3, lines 33-35); and/or
in the expanded state, the cross-sectional area of the second holes is 10 ~ 50 mm2, and/or, the shape of the second holes is rhombus (shape of the slits is rhombic, or diamond-shaped, in figs. 3B, 3C, 5, and 7), and/or, the aperture of the first holes is 10 µm ~ 80 µm and
an unexpanded state (balloon assembly 10 with balloon 18 in its unexpanded diametric state in figs. 1A and 3A; col. 6, lines 39-40)
Modified Palmaz fails, however, to expressly disclose that in the unexpanded state and during the process of moving from the unexpanded state to the expanded state, the drug solution remains inside the balloon or only a small amount of drug solution seeps out from the first holes.
Chien teaches that in the unexpanded state and during the process of moving from the unexpanded state to the expanded state, the drug solution remains inside the balloon or only a small amount of drug solution seeps out from the first holes (Chien: infusion holes 15 are preferably open when the balloon 14 is deflated; balloon 14 is inflated using the inflation syringe by slowly infusing the desired volume of inflation fluid. In some embodiments, inflation fluid will immediately leak out of the infusion holes 15, and therefore it is desirable to quickly inflate the balloon 14 such that the balloon 14 engages the vascular wall or occlusive material without substantial loss of inflation fluid; col. 3, lines 25-32 and col. 7, lines 7-15).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select the number and aperture of the first holes of modified Palmaz such that, in the expanded state, the drug solution can be sprayed out from the first holes, while in the unexpanded state and during expansion only a small amount of drug solution seeps out (or remains substantially inside the balloon), as taught by Chien, in order to allow controlled inflation of the balloon with minimal premature drug loss and effective delivery once the balloon is fully expanded and the outer sleeve slits have opened.
Regarding claim 7, modified Palmaz discloses the vascular stenosis treatment apparatus according to claim 1, wherein, the distal end (distal end 13 in figs. 1A-1B) of the covering member (sleeve 12 in figs. 1A-1B) is fixedly connected to the distal end of the balloon, and the proximal end (proximal end 11 in figs. 1A-1B) of the covering member is fixedly connected to the proximal end of the balloon (sleeve 12 is mounted on an underlying drug-eluting balloon catheter 16. The sleeve 12 has a proximal end 11 and a distal end 13 that are joined to the drug-eluting balloon catheter 16 to couple the sleeve 12 to the drug-eluting balloon catheter 16; col. 6, lines 35-39); and/or
the vascular stenosis treatment apparatus further comprises a first catheter partially located within the balloon and connected to the distal end of the balloon in a sealed manner or integrally formed with the distal end of the balloon, a second catheter sleeved outside the first catheter and connected to the proximal end of the balloon in a sealed manner or integrally formed with the proximal end of the balloon, and a catheter seat respectively connected to the proximal end of the first catheter and the proximal end of the second catheter, forming a drug delivery channel between the first catheter and the second catheter.
Regarding claim 8, modified Palmaz discloses the vascular stenosis treatment apparatus according to claim 1, wherein the covering member is provided that part or all of the covering member moves relative to the outer surface of the balloon to generate a cutting action when the balloon is expanded (when sleeve 12 is expanded against a diseased surface in the body, such as vascular plaque, the elongate member acts as a cutting surface to penetrate into the diseased tissue; col. 2, lines 32-34; col. 6, lines 18-32).
Regarding claim 9, modified Palmaz discloses the vascular stenosis treatment apparatus according to claim 8, wherein when the balloon transitions from the unexpanded state (balloon assembly 10 with balloon 18 in its unexpanded diametric state in figs. 1A and 3A; col. 6, lines 39-40) to the expanded state (balloon assembly 10 with balloon 18 in its expanded diametric state in figs. 1B and 3B; col. 6, lines 41-42), the contact area between part or all of the covering member and the peripheral surface of the balloon is changed to realize the cutting of an intravascular lesion site by the covering member (when sleeve 12 is expanded against a diseased surface in the body, such as vascular plaque, the elongate member acts as a cutting surface to penetrate into the diseased tissue; col. 2, lines 32-34; col. 6, lines 18-32); and/or
during or after the covering member carries out the cutting, the drug solution is sprayed out from the first holes.
Regarding claim 10, modified Palmaz discloses the vascular stenosis treatment apparatus according to claim 9, wherein the covering member (sleeve 20 configured as a tubular sleeve 30 in figs. 3A-3B; col. 8, lines 64-66) comprises a plurality of covering elements (land regions 35 in figs. 3A-3C) and a plurality of connection points (hinge regions 37 in figs. 3A-3C);
when the covering member is in the unexpanded state (balloon assembly 10 with balloon 18 in its unexpanded diametric state in figs. 1A and 3A; col. 6, lines 39-40), each of the covering elements has a length extending along the axial direction of the covering member, and the plurality of covering elements is distributed along the circumferential direction (land regions 35 are oriented in the axial direction of sleeve 20 with a plurality of land regions 35 distributed along the circumferential direction in figs. 3A-3B; col. 8, line 57 – col. 9, line 45);
two adjacent covering elements are fixedly connected through the plurality of connection points, and two adjacent connection points on the same covering element are respectively located on two opposite sides of the covering element and are staggered with each other (adjacent regions are connected via hinge regions 37 which are arranged in an off-set pattern with each other in figs. 3A-3C);
when the covering member transitions from the unexpanded state to the expanded state (balloon assembly 10 with balloon 18 in its expanded diametric state in figs. 1B and 3B; col. 6, lines 41-42), the covering elements are flipped, and two adjacent connection points connected to the same covering element move respectively towards directions close to the balloon and away from the balloon (when sleeve 12 is expanded against a diseased surface in the body, such as vascular plaque, the elongate member acts as a cutting surface to penetrate into the diseased tissue; col. 2, lines 25-39; land regions 35 rotate about their own axis and projects outwardly to penetrate or press into adjacent biological tissue, such as vascular tissue, to aid in drug absorption; col. 6, lines 18-32).
Regarding claim 11, modified Palmaz discloses the vascular stenosis treatment apparatus according to claim 10, wherein the plurality of connection points is respectively located in a plurality of planes parallel to each other, the planes are perpendicular to the axis line of the covering member, and the distances between two adjacent planes are equal; and/or
when the covering member is in the unexpanded state, the width of the covering elements is greater than the thickness of the covering elements; and/or
the connection points have a length of 0.5 ~ 3 mm; and/or, the connection points have a thickness of 0.02 ~ 0.2 mm; and/or, the connection points have a width of 0.1 ~ 0.5 mm; and/or, the thickness of the connection points is equal to the thickness of the covering elements; and/or,
the plurality of covering elements and the plurality of connection points together form the plurality of second holes (a plurality of slits 14 are formed in the sleeve 12 and pass through wall surfaces thereof. Each of the plurality of slits 14 are elongate along a longitudinal axis of the sleeve 12 and communicate between a luminal surface of the sleeve 12 and an abluminal surface of the sleeve 12. The plurality of slits 14 are arrayed in a pattern along an intermediate section 17 of the sleeve 12; col. 6, lines 42-59), and in the expanded state (balloon assembly 10 with balloon 18 in its expanded diametric state in figs. 1B and 3B; col. 6, lines 41-42), the covering elements (land regions 35 in figs. 3A-3C) enclose outside the first holes to form a plurality of independent drug delivery spaces (slits 14 open upon expansion to create open spaces for drug delivery between the land regions 15/35 in figs. 1B and 3b); and/or,
when the covering member is in the expanded state, the second holes are rhombic, and in the same rhombus, the connection points at two opposite vertexes of this rhombus are located on the inner side of the covering member, and the connection points at the other two opposite vertexes of this rhombus are located on the outer side of the covering member.
Regarding claim 12, modified Palmaz discloses the vascular stenosis treatment apparatus according to claim 11, wherein when the covering member (sleeve 20 configured as a tubular sleeve 30 in figs. 3A-3B; col. 8, lines 64-66) is in the unexpanded state (balloon assembly 10 with balloon 18 in its unexpanded diametric state in figs. 1A and 3A; col. 6, lines 39-40), the width of the covering elements is 2 ~ 10 times the thickness of the covering elements (land region 35 widths may be between about 5μm and about 50μm; col. 6, lines 6-7; land region 35 thickness is equivalent to the thickness of the sleeve; col. 6, lines 8-10; sleeve 12/20 has thickness in range 0.1µm - 75µm; therefore, choosing 2.5μm - 5μm thickness is within claimed range of covering element thickness and correlates to 5μm - 50μm width).
Regarding claim 13, modified Palmaz discloses the vascular stenosis treatment apparatus according to claim 8, wherein the covering member is formed by cutting a cylindrical tube; and/or, the material of the covering member is metal; and/or, the material of the covering member is selected from the group consisting of memory alloy, stainless steel, titanium alloy, nickel alloy, cobalt-chromium alloy, and combinations thereof (sleeve 12 is preferably made of super-elastic material, including metals such as nickel-titanium alloys; col. 4, line 66 – col. 5, line 13).
Regarding claim 14, modified Palmaz discloses the vascular stenosis treatment apparatus according to claim 10, wherein the covering member (sleeve 12 is mounted on underlying drug-eluting balloon catheter 16 and has a proximal end 11 and a distal end 13 that are joined to the drug-eluting balloon catheter 16 to couple the sleeve 12 to the drug-eluting balloon catheter 16 in figs. 1A-1B; col. 6, lines 35-39) further comprises a first connecting member located at the distal end (distal end 13 of sleeve 12 connection to drug-eluting balloon catheter 16 in figs. 1A-1B) of the covering member and a second connecting member located at the proximal end of the covering member (proximal end 11 of sleeve 12 connection to drug-eluting balloon catheter 16 in figs. 1A-1B), the first connecting member is fixedly connected to the distal end of the balloon and the distal ends of the covering elements, respectively, and the second connecting member is fixedly connected to the proximal end of the balloon and the proximal ends of the covering elements, respectively (proximal end 11 and distal end 13 may be used to couple the sleeve 12 to the drug-eluting balloon catheter 16 in figs. 1A-1B; col. 6, lines 51-53); and/or
the covering member further comprises a first connecting member located at the distal end of the covering member, a second connecting member located at the proximal end of the covering member, a first extension member fixedly connected to the proximal end of the first connecting member and the distal ends of the covering elements and capable of being elongated or shortened, and a second extension member fixedly connected to the distal end of the second connecting member and the proximal ends of the covering elements and capable of being elongated or shortened, the first connecting member is fixedly connected to the distal end of the balloon, and the second connecting member is fixedly connected to the proximal end of the balloon; the length of the first extension member when the balloon is in the unexpanded state is less than that of the first extension member when the balloon is in the expanded state, and the length of the second extension member when the balloon is in the unexpanded state is less than that of the second extension member when the balloon is in the expanded state.
Regarding claim 15, modified Palmaz discloses the vascular stenosis treatment apparatus according to claim 14, wherein the balloon comprises a first head portion at the distal end, a second head portion at the proximal end, and a balloon body fixedly connected to the first head portion and the second head portion, the first connecting member is fixedly connected to the first head portion, the second connecting member is fixedly connected to the second head portion, and the covering elements extend on the peripheral surface of the entire balloon; and/or,
the first connecting member (distal end 13 of sleeve 12 connection to drug-eluting balloon catheter 16 in figs. 1A-1B) and the second connecting member (proximal end 11 of sleeve 12 connection to drug-eluting balloon catheter 16 in figs. 1A-1B) are respectively circular rings (proximal and distal ends of sleeve 12 connecting to drug-eluting balloon catheter 16 are joined as annular, or ring-like, connection structures in figs. 1A-1B), or are respectively closed rings having peaks and valleys regularly arranged along the circumferential direction with the axis line of the covering member as the axis; and/or,
in the unexpanded state, the first extension member and the second extension member are respectively a plurality of wavy lines uniformly distributed along the circumferential direction with the axis line of the covering member as the axis; and/or,
in the expanded state, the connections between the first extension member and the covering elements and the connections between the second extension member and the covering elements are located in the positions where the diameter of the balloon becomes to increase when it transitions from the unexpanded state to the expanded state; and/or,
the connection between the first connecting member and the first extension member and the connection between the second connecting member and the second extension member are located in the positions where the diameter of the balloon becomes to increase when it transitions from the unexpanded state to the expanded state.
Regarding claim 16, modified Palmaz discloses the vascular stenosis treatment apparatus according to claim 2, wherein, the coverage rate of the peripheral surface of the balloon by the covering member in the unexpanded state (balloon assembly 10 with balloon 18 in its unexpanded diametric state in figs. 1A and 3A; col. 6, lines 39-40) is greater than that of the peripheral surface of the balloon by the covering member in the expanded state (sleeve 12 is diametrically expandable with a plurality of elongate slits in figs. 1A-1B and 3A-3B; the unexpanded state in figs. 1A and 3A show the slits closed or of minimal width so the sleeve covers a high percentage of the underlying balloon catheter 16; in the expanded state in figs. 1B and 3B, the slits open significantly, thereby decreasing the coverage rate of the balloon surface); and/or,
in the expanded state and/or during the process of moving from the unexpanded state to the expanded state, the balloon and the covering member are attached to each other (sleeve 12 is mounted on underlying drug-eluting balloon catheter 16 and has a proximal end 11 and a distal end 13 that are joined to the drug-eluting balloon catheter 16 to couple the sleeve 12 to the drug-eluting balloon catheter 16 in figs. 1A-1B; col. 6, lines 35-39).
Regarding claim 17, modified Palmaz discloses the vascular stenosis treatment apparatus according to claim 7, wherein, the covering member (sleeve 12 in figs. 1A-1B; col. 6, lines 34-35) is provided that part or all of the covering member moves relative to the outer surface of the balloon to generate a cutting action when the balloon is expanded (when sleeve 12 is expanded against a diseased surface in the body, such as vascular plaque, the elongate member acts as a cutting surface to penetrate into the diseased tissue; col. 2, lines 32-34; col. 6, lines 18-32).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZACHARIAH K WHITROCK whose telephone number is (571) 272-3534. The examiner can normally be reached Monday - Friday 8:00 am - 5:00 pm.
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/ZACHARIAH K WHITROCK/Patent Examiner, Art Unit 3783
/WESLEY G HARRIS/Examiner, Art Unit 3783
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