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 .
Notice of Amendment
In response to the amendment filed on 10/28/2025, amended claims 1 and 23-26 and new claim 35 are acknowledged. Claims 1-35 are currently pending. The following new and reiterated grounds of rejection are set forth:
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1, 5-9, 11-13, 15-16, 18-19, 22-27, and 35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Benning et al. (US Publication No. 2018/0140289 A1) (cited by Applicant), further in view of Asselin et al. (US Patent No. 8,979,832 B2).
Regarding claim 1, Benning et al. discloses a device comprising:
a cylindrical member having a distal end and a proximal end, wherein the cylindrical member includes a plurality of longitudinal slits positioned between the distal end and the proximal end to thereby create a plurality of strips (124, 724) positioned between the plurality of longitudinal slits (see Figures 1-4 and 7-8);
an elongated hollow tube (108, 703) having a distal end and a proximal end, wherein the elongated hollow tube is coupled to the proximal end of the cylindrical member (see Figures 1-4 and 7-8 and [0034] – “One or more bands 124 may be coupled to both a distal end 126 of push rod 122, and to the distal end 110 of piercing shaft 108”); and
a rod (122, 708) having a distal end and a proximal end, wherein the rod is positioned at least partially within the elongated hollow tube, wherein an axial movement of the rod with respect to the elongated hollow tube causes the cylindrical member to transition from a retracted position in which the plurality of strips are aligned with the distal end and the proximal end of the cylindrical member (see Figure 3 and 7) to an expanded position in which the plurality of strips protrude radially outward from the distal end and the proximal end of the cylindrical member (see Figures 1-2, 4, and 8), and wherein a diameter of the cylindrical member in the expanded position is greater than a diameter of the cylindrical member in the retracted position (see Figures 1-2 and 4 and [0034] – “Push rod 122 may be advanced distally relative to a stationary piercing shaft 108 (or piercing shaft 108 may be pulled proximally relative to push rod 122 while push rod 122 is held stationary) to cause the one or more bands 124 to move from the radially-collapsed configuration of FIG. 3 to the radially-expanded configuration of FIG. 2).
Benning et al. teaches each of the plurality of longitudinal slits includes a cutting edge (see [0035] – “For example, band 124 may include sharp outer edges”) but does not specifically teach each of the plurality of longitudinal slits includes a cutting edge oriented to cut in a proximal direction in response to a movement of the cylindrical member in the proximal direction. However, Asselin et al. teaches each of the plurality of longitudinal slits includes a cutting edge oriented to cut in a proximal direction in response to a movement of the cylindrical member in the proximal direction (see Figure 8C and col. 8, lines 54-59 – “In some embodiments, at least one of legs 270 may include an inward facing sharp cutting edge 23 as depicted in FIG. 8C. In an embodiment, each of legs 270 includes a sharp edge 23. A cross-section of leg 270 may be a triangular or a three-sided shape with two curved, concave sides forming the sharp cutting edge 23” and col. 11, lines 39-45 – “For example, this may be accomplished by pulling elongate member 12 proximally relative to sheath 11 so that retrieval assembly 240 begins to retract and collapse into sheath 11, and consequently, a portion of the entrapped object is cut into multiple pieces by the inward facing sharp cutting edges 23 of legs 270”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Benning et al. to include each of the plurality of longitudinal slits includes a cutting edge oriented to cut in a proximal direction in response to a movement of the cylindrical member in the proximal direction, as disclosed in Asselin et al., so as to cut the entrapped object to reduce the entrapped object’s size before removing it from the body (see Asselin et al.: col. 11, lines 13-15).
Regarding claim 5, it is noted Benning et al. does not specifically teach a length of the cylindrical member ranges from about 8 mm to about 15 mm. However, it would have been an obvious matter of design choice to make a length of the cylindrical member between about 8 mm and about 15 mm, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Regarding claim 6, Benning et al. discloses the rod comprises a braided cable (see [0042] – “In some examples, a wire, cable, or other suitable member may be used instead of rod 708”).
Regarding claim 7, Benning et al. discloses the rod is solid (see Figures 7-8 and [0042] – “In some examples, a wire, cable, or other suitable member may be used instead of rod 708”).
Regarding claim 8, Benning et al. discloses the rod includes a lumen (120), and wherein the distal end of the elongated hollow tube includes a plurality of through-holes to enable suction of samples extracted via the plurality of strips out of the lumen of the rod (see [0037] – “the band 124 may be a substantially hollow wire having one or more holes (not shown) disposed on its surface. This arrangement may facilitate additional capabilities, such as irrigation, aspiration, medication delivery, or lubrication, before, during, or after the cutting process”).
Regarding claim 9, Benning et al. discloses a cap (112, 712) positioned at the distal end of the cylindrical member, wherein the distal end of the rod is coupled to the cap (see Figures 1-4 and 7-8).
Regarding claim 11, Benning et al. discloses a diameter of the cap is equal to the diameter of the cylindrical member in the retracted position (see Figure 3).
Regarding claim 12, it is noted Benning et al. does not specifically teach the cap is cylindrical in shape. However, it would have been an obvious matter of design choice to one skilled in the art before the effective filing date of the claimed invention to construct the cap to be cylindrical in shape, since applicant has not disclosed that such solves any stated problem or is anything more than one of numerous shapes or configurations a person of ordinary skill in the art would find obvious for the purpose of coupling the rod to the cap. In re Dailey and Eilers, 149 USPQ 47 (1966).
Regarding claim 13, Benning et al. discloses the cap is conical in shape (see [0032] – “The piercing tip 112 may have any suitable piercing or needle tip shapes and/or geometries, such as, e.g., a single bevel, multiple bevels, conical, Sprotte, diamond, Franseen, Tuohy, or the like”).
Regarding claim 15, Benning et al. discloses the cylindrical member comprises a shape memory material (see [0035] – “The one or more bands 124 may include any suitable material, such as, e.g., stainless steel, a shape memory material (nitinol, elgiloy or the like), or another suitable material”).
Regarding claim 16, Benning et al. discloses the rod comprises a guidewire (see [0042] – “In some examples, a wire, cable, or other suitable member may be used instead of rod 708”), and wherein the device further includes:
a clamp (148) configured to prevent a longitudinal movement of the guidewire (see [0038] – “Subassembly 144 may be coupled to a proximal end of push rod 122, and may move longitudinally within housing 142 to transition biopsy device 100 from the radially-collapsed configuration to the radially-expanded configuration. One or more locking features 148 may be disposed on an outer surface of subassembly 144, and may be configured to interact with corresponding locking features 151 on an inner surface of housing 142. The interaction of locking features 148 and 151 may maintain subassembly 144 in a distal portion of housing 142, which may help keep biopsy device 106 in the radially-expanded configuration. Subassembly 144 also may be configured to rotate biopsy device 106 in order to allow the one or more bands 124 to slice through tissue”); and
a hand grip (142) coupled to the proximal end of the elongated hollow tube, wherein the hand grip is positioned between the clamp and the elongated hollow tube (see Figures 5-6).
Regarding claim 18, Benning et al. discloses the plurality of strips are coupled to an electrical source to provide heat to the plurality of strips (see [0035] – “For example, band 124 may conduct electricity. Electrocauterization is the process of damaging or destroying tissue using heat generated by passing an electric current through a conductive probe or wire”).
Regarding claim 19, Benning et al. discloses the plurality of strips include spikes extending in a radial direction away from an outer surface of the plurality of strips (see [0037] – “Band 124 may also comprise abrasive coatings or projections, such as barbs, saw, or blades, although such protrusions may be sized to allow movement of the bands 124 through openings 114”).
Regarding claim 22, Benning et al. discloses a sheath (102, 702) configured to be removably positioned over at least a portion of the elongated hollow tube and at least a portion of the cylindrical member (see Figures 1 and 7).
Regarding claim 23, Benning et al. discloses each of the plurality of strips includes a first edge adjacent a first slit of the plurality of longitudinal slits and a second edge adjacent a second slit of the plurality of longitudinal slits, and wherein the first edge comprises cutting edge (see [0035] – “In one example, band 124 may be any suitable wire capable of cutting tissue. For example, band 124 may include sharp outer edges”). Asselin et al. also teaches each of the plurality of strips includes a first edge adjacent a first slit of the plurality of longitudinal slits and a second edge adjacent a second slit of the plurality of longitudinal slits, and wherein the first edge comprises cutting edge (see Figure 8C and col. 8, lines 54-59 – “In some embodiments, at least one of legs 270 may include an inward facing sharp cutting edge 23 as depicted in FIG. 8C. In an embodiment, each of legs 270 includes a sharp edge 23. A cross-section of leg 270 may be a triangular or a three-sided shape with two curved, concave sides forming the sharp cutting edge 23”).
Regarding claim 24, Benning et al. discloses the cutting edge is serrated (see [0037] – “Band 124 may also comprise abrasive coatings or projections, such as barbs, saw, or blades, although such protrusions may be sized to allow movement of the bands 124 through openings 114”).
Regarding claim 25, Benning et al. discloses the cutting edge comprises a plurality of teeth (see [0037] – “Band 124 may also comprise abrasive coatings or projections, such as barbs, saw, or blades, although such protrusions may be sized to allow movement of the bands 124 through openings 114”).
Regarding claim 26, Benning et al. discloses the cutting edge comprises a plurality of barbs (see [0037] – “Band 124 may also comprise abrasive coatings or projections, such as barbs, saw, or blades, although such protrusions may be sized to allow movement of the bands 124 through openings 114”).
Regarding claim 27, Benning et al. discloses both the first edge and the second edge are cutting edges (see [0035] – “In one example, band 124 may be any suitable wire capable of cutting tissue. For example, band 124 may include sharp outer edges”). Asselin et al. further teaches both the first edge and the second edge are cutting edges (see Figure 8C and col. 8, lines 54-59 – “In some embodiments, at least one of legs 270 may include an inward facing sharp cutting edge 23 as depicted in FIG. 8C. In an embodiment, each of legs 270 includes a sharp edge 23. A cross-section of leg 270 may be a triangular or a three-sided shape with two curved, concave sides forming the sharp cutting edge 23”).
Regarding claim 35, Asselin et al. teaches when the cylindrical member is in the expanded position, the cutting edges of the plurality of longitudinal slits extend along an entire diameter of the cylindrical member (see Figures 8A-C and col. 8, lines 54-59 – “In some embodiments, at least one of legs 270 may include an inward facing sharp cutting edge 23 as depicted in FIG. 8C. In an embodiment, each of legs 270 includes a sharp edge 23. A cross-section of leg 270 may be a triangular or a three-sided shape with two curved, concave sides forming the sharp cutting edge 23”).
Claim(s) 2-3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Benning et al. and Asselin et al., further in view of Rains et al. (US Publication No. 2012/0179161 A1) (previously cited).
Regarding claim 2, it is noted neither Benning et al. nor Asselin et al. specifically teach each of the plurality of longitudinal slits comprise a first straight section, a second straight section, and an angled section between the first straight section and the second straight section. However, Rains et al. teaches each of the plurality of longitudinal slits (26b) comprise a first straight section, a second straight section, and an angled section between the first straight section and the second straight section (see Figures 12-16 and [0049] – “The helical cutting arms 26b reduce tensile and shear stresses at the bases 29 (FIG. 16) of the cutting arm 26b so as to reduce the possibility of device failure. The helix formed by the helical cutting arms 26b can be designed to optimize the ease of cutting. The helix can be left-hand helical or right-hand helical and can be formed at an angle from about negative 60 degree to about 60 degrees from a longitudinal axis of the surgical instrument”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Benning et al. and Asselin et al. to include each of the plurality of longitudinal slits comprise a first straight section, a second straight section, and an angled section between the first straight section and the second straight section, as disclosed in Rains et al., so as to optimize the ease of cutting and reduce the possibility of device failure (see Rains et al.: [0049]).
Regarding claim 3, Rains et al. teaches an angle between the first straight section and the angled section ranges from about 105 degrees to about 135 degrees (see [0049] – “The helical cutting arms 26b reduce tensile and shear stresses at the bases 29 (FIG. 16) of the cutting arm 26b so as to reduce the possibility of device failure. The helix formed by the helical cutting arms 26b can be designed to optimize the ease of cutting. The helix can be left-hand helical or right-hand helical and can be formed at an angle from about negative 60 degree to about 60 degrees from a longitudinal axis of the surgical instrument”).
Claim(s) 4 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Benning et al. and Asselin et al., further in view of Majercak et al. (US Publication No. 2016/0374714 A1) (cited by Applicant).
Regarding claim 4, it is noted neither Benning et al. nor Asselin et al. specifically teach an outer diameter of the cylindrical member ranges from about 0.5 mm to about 4 mm. However, Majercak et al. teaches an outer diameter of the cylindrical member ranges from about 0.5 mm to about 4 mm (see [0031] – “While the initial working diameter D1 is shown here, it is noted that the starting diameter D of the cutting basket is intended to be smaller and not significantly greater than the outermost diameter of the catheter 100. In most instances, the starting outer diameter of the outer cutting basket will be substantially the same as the inner diameter of the delivery catheter” and [0032] – “In the embodiments described herein, D is about 1.2 mm, D1 is about 1.6 mm, D2 is about 2.0 mm and D3 is about 3.5 mm”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Benning et al. and Asselin et al. to include an outer diameter of the cylindrical member ranges from about 0.5 mm to about 4 mm, as disclosed in Majercak et al., so as to configure the device to work with the largest biological vessel without damaging the vessel wall (see Majercak et al.: [0032]).
Regarding claim 14, it is noted neither Benning et al. nor Asselin et al. specifically teach the diameter of the cylindrical member in the expanded position ranges from about 1.25 times greater than the diameter of the cylindrical member in the retracted position to about 3 times greater than the diameter of the cylindrical member in the retracted position. However, Majercak et al. teaches the diameter of the cylindrical member in the expanded position ranges from about 1.25 times greater than the diameter of the cylindrical member in the retracted position to about 3 times greater than the diameter of the cylindrical member in the retracted position (see [0032] – “In the embodiments described herein, D is about 1.2 mm, D1 is about 1.6 mm, D2 is about 2.0 mm and D3 is about 3.5 mm”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Benning et al. and Asselin et al. to include the diameter of the cylindrical member in the expanded position ranges from about 1.25 times greater than the diameter of the cylindrical member in the retracted position to about 3 times greater than the diameter of the cylindrical member in the retracted position, as disclosed in Majercak et al., so as to configure the device to work with the largest biological vessel without damaging the vessel wall (see Majercak et al.: [0032]).
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Benning et al. and Asselin et al., further in view of Sankaran et al. (US Patent No. 9,089,347 B2) (previously cited).
Regarding claim 17, it is noted neither Benning et al. nor Asselin et al. specifically teach a ratchet mechanism positioned between the clamp and the elongated hollow tube, wherein the ratchet mechanism maintains a position of the hand grip with respect to the cylindrical member to hold the cylindrical member in the expanded position until the ratchet mechanism is released. However, Sankaran et al. teaches a ratchet mechanism positioned between the clamp and the elongated hollow tube, wherein the ratchet mechanism maintains a position of the hand grip with respect to the cylindrical member to hold the cylindrical member in the expanded position until the ratchet mechanism is released (see col. 24, lines 49-52 – “In addition, any of the embodiments of a medical device can include a ratchet mechanism operatively coupled to the actuator. This would allow the medical device to be actuated or expanded/collapsed at different increments and /or sizes”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Benning et al. and Asselin et al. to include a ratchet mechanism positioned between the clamp and the elongated hollow tube, wherein the ratchet mechanism maintains a position of the hand grip with respect to the cylindrical member to hold the cylindrical member in the expanded position until the ratchet mechanism is released, as disclosed in Sankaran et al., so as to allow the cylindrical member to be expanded/collapsed at different increments and/or sizes (see Sankaran et al.: col. 24, lines 49-52).
Claim(s) 20-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Benning et al. and Asselin et al., further in view of Chu (US Publication No. 2017/0319222 A1) (previously cited).
Regarding claim 20, it is noted neither Benning et al. nor Asselin et al. specifically teach a pre-loaded spring configured to rotate the cylindrical member once the cylindrical member is in the expanded position. However, Chu teaches a pre-loaded spring (50) configured to rotate the cylindrical member once the cylindrical member is in the expanded position (see [0033] – “A resilient element 50 is depicted in FIGS. 1A-B as being placed in cavity 45. Element 50 may be a spring, which may made of metal or other resilient material. Interface 46 may be attached to distal end 40D of housing 40 to, for example, retain catch portion 22 of plunger 20 and resilient element 50 in interior cavity 45, thereby allowing plunger 20 to be mounted for movement in housing 40”, [0035] – “Resilient element 50 biases plunger 20 proximally along axis X-X by generating an axial response force that, when axial force A is released, moves plunger 20 proximally. Element 50 also may bias plunger 20 rotationally about axis X-X towards an initial position of alignment with housing 40. For example, element 50 may be a spring that is attached to plunger 20 and housing 40 and, thus, torqued when plunger 20 is rotated about axis X-X, under rotational force R, resulting in a rotational response force that, when rotational force R is released, returns plunger 20 to the initial position”, and [0055] – “In one example, step 410 may further comprise positioning an opening 71 of end effector 70 adjacent material 1M, and applying axial force A to plunger 20 in order to place material 1M into basket 72 by moving (e.g., flexing) one or more segments 73 until the opening 71 is large enough to receive material 1M (e.g., FIG. 5A). In another example, step 410 may comprise positioning an opening 71 adjacent material 1M such that at least one segment 73 is placed in contact with an interior surface of the body cavity 1, and using rotational force R to “spin scoop” material 1M into basket 72 by moving (e.g., rotating) at least one segment 73 against the interior surface and towards another segment 73 until the opening 71 is large enough to receive material 1M (e.g., FIG. 5B). In either example, when axial force A or rotational force R is released, then the resiliency of basket 72, and/or the responsive forces applied by resilient element 50, may aid in capturing material 1M”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Benning et al. and Asselin et al. to include a pre-loaded spring configured to rotate the cylindrical member once the cylindrical member is in the expanded position, as disclosed in Chu, so as to “spin scoop” material into the cylindrical member by rotating the cylindrical member against an interior surface of the body cavity (see Chu: [0055]).
Regarding claim 21, Chu teaches the pre-loaded spring is automatically triggered once the rod exceeds a certain length of movement in a proximal direction (see [0033] – “A resilient element 50 is depicted in FIGS. 1A-B as being placed in cavity 45. Element 50 may be a spring, which may made of metal or other resilient material. Interface 46 may be attached to distal end 40D of housing 40 to, for example, retain catch portion 22 of plunger 20 and resilient element 50 in interior cavity 45, thereby allowing plunger 20 to be mounted for movement in housing 40”, [0035] – “Resilient element 50 biases plunger 20 proximally along axis X-X by generating an axial response force that, when axial force A is released, moves plunger 20 proximally. Element 50 also may bias plunger 20 rotationally about axis X-X towards an initial position of alignment with housing 40. For example, element 50 may be a spring that is attached to plunger 20 and housing 40 and, thus, torqued when plunger 20 is rotated about axis X-X, under rotational force R, resulting in a rotational response force that, when rotational force R is released, returns plunger 20 to the initial position”, and [0055] – “In one example, step 410 may further comprise positioning an opening 71 of end effector 70 adjacent material 1M, and applying axial force A to plunger 20 in order to place material 1M into basket 72 by moving (e.g., flexing) one or more segments 73 until the opening 71 is large enough to receive material 1M (e.g., FIG. 5A). In another example, step 410 may comprise positioning an opening 71 adjacent material 1M such that at least one segment 73 is placed in contact with an interior surface of the body cavity 1, and using rotational force R to “spin scoop” material 1M into basket 72 by moving (e.g., rotating) at least one segment 73 against the interior surface and towards another segment 73 until the opening 71 is large enough to receive material 1M (e.g., FIG. 5B). In either example, when axial force A or rotational force R is released, then the resiliency of basket 72, and/or the responsive forces applied by resilient element 50, may aid in capturing material 1M”).
Claim(s) 28-34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Benning et al. in view of Asselin et al., or Benning et al. in view of Asselin et al. and Rains et al., or Benning et al. in view of Asselin et al. and Majercak et al., or Benning et al. in view of Asselin et al. and Sankaran et al., or Benning et al. in view of Asselin et al. and Chu.
Regarding claim 28, Benning et al. teaches a method for extracting a biopsy sample from a target anatomy, the method comprising:
positioning the cylindrical member of the device of any one of claims 1-27 (see rejections above) adjacent the target anatomy;
transitioning the cylindrical member from the retracted position to the expanded position (see [0034] – “The bands 124 may be reciprocally movable between a radially-collapsed configuration (FIG. 3) and a radially-expanded configuration (FIG. 2) via actuation of push rod 122”);
moving the cylindrical member with respect to the target anatomy to capture the biopsy sample from the target anatomy (see [0045] – “A physician may collect a sample disposed radially outward of a surface that defines a body lumen with either biopsy device 106 or biopsy device 700 by piercing the surface via a respective piercing tip, while the biopsy device is in the closed configuration. Then, the respective biopsy device may be transitioned from the closed configuration to the expanded configuration by an actuating mechanism, such as, e.g., handle 140 described with reference to FIGS. 5 and 6. Once the one or more bands are radially expanded, they may be rotated to pierce through the tissue to be collected. Once the tissue has been cut, the biopsy device may be repositioned to place bands 124 radially outward of the severed tissue, after which bands 124 may be transitioned back to the radially collapsed configuration, trapping removed tissue within the device”);
transitioning the cylindrical member from the expanded position to the retracted position (see [0045] – “A physician may collect a sample disposed radially outward of a surface that defines a body lumen with either biopsy device 106 or biopsy device 700 by piercing the surface via a respective piercing tip, while the biopsy device is in the closed configuration. Then, the respective biopsy device may be transitioned from the closed configuration to the expanded configuration by an actuating mechanism, such as, e.g., handle 140 described with reference to FIGS. 5 and 6. Once the one or more bands are radially expanded, they may be rotated to pierce through the tissue to be collected. Once the tissue has been cut, the biopsy device may be repositioned to place bands 124 radially outward of the severed tissue, after which bands 124 may be transitioned back to the radially collapsed configuration, trapping removed tissue within the device”); and
removing the device from the target anatomy (see [0045] – “A physician may collect a sample disposed radially outward of a surface that defines a body lumen with either biopsy device 106 or biopsy device 700 by piercing the surface via a respective piercing tip, while the biopsy device is in the closed configuration. Then, the respective biopsy device may be transitioned from the closed configuration to the expanded configuration by an actuating mechanism, such as, e.g., handle 140 described with reference to FIGS. 5 and 6. Once the one or more bands are radially expanded, they may be rotated to pierce through the tissue to be collected. Once the tissue has been cut, the biopsy device may be repositioned to place bands 124 radially outward of the severed tissue, after which bands 124 may be transitioned back to the radially collapsed configuration, trapping removed tissue within the device”).
Regarding claim 29, Benning et al. teaches moving the cylindrical member with respect to the target anatomy to capture the biopsy sample from the target anatomy comprises rotating the cylindrical member about a longitudinal axis of the cylindrical member (see [0038] – “Subassembly 144 also may be configured to rotate biopsy device 106 in order to allow the one or more bands 124 to slice through tissue” and [0045] – “Once the one or more bands are radially expanded, they may be rotated to pierce through the tissue to be collected”).
Regarding claim 30, Benning et al. teaches moving the cylindrical member with respect to the target anatomy to capture the biopsy sample from the target anatomy comprises moving the cylindrical member in a proximal direction with respect to the target anatomy (see [0034] – “Push rod 122 may be advanced distally relative to a stationary piercing shaft 108 (or piercing shaft 108 may be pulled proximally relative to push rod 122 while push rod 122 is held stationary) to cause the one or more bands 124 to move from the radially-collapsed configuration of FIG. 3 to the radially-expanded configuration of FIG. 2”). Asselin et al. teaches moving the cylindrical member with respect to the target anatomy to capture the biopsy sample from the target anatomy comprises moving the cylindrical member in a proximal direction with respect to the target anatomy (see col. 11, lines 39-45 – “For example, this may be accomplished by pulling elongate member 12 proximally relative to sheath 11 so that retrieval assembly 240 begins to retract and collapse into sheath 11, and consequently, a portion of the entrapped object is cut into multiple pieces by the inward facing sharp cutting edges 23 of legs 270”).
Regarding claim 31, Benning et al. teaches moving the cylindrical member with respect to the target anatomy to capture the biopsy sample from the target anatomy comprises simultaneously rotating the cylindrical member about a longitudinal axis of the cylindrical member and moving the cylindrical member in a proximal direction with respect to the target anatomy (see [0034] – “Push rod 122 may be advanced distally relative to a stationary piercing shaft 108 (or piercing shaft 108 may be pulled proximally relative to push rod 122 while push rod 122 is held stationary) to cause the one or more bands 124 to move from the radially-collapsed configuration of FIG. 3 to the radially-expanded configuration of FIG. 2”, [0039] – “Other handles and actuation mechanisms are also contemplated, including, e.g., manually-operated handles and mechanisms that cause the longitudinal and rotational movement of the bands 124”, and [0045] – “Then, the respective biopsy device may be transitioned from the closed configuration to the expanded configuration by an actuating mechanism, such as, e.g., handle 140 described with reference to FIGS. 5 and 6. Once the one or more bands are radially expanded, they may be rotated to pierce through the tissue to be collected. Once the tissue has been cut, the biopsy device may be repositioned to place bands 124 radially outward of the severed tissue, after which bands 124 may be transitioned back to the radially collapsed configuration, trapping removed tissue within the device”). Asselin et al. teaches moving the cylindrical member with respect to the target anatomy to capture the biopsy sample from the target anatomy comprises simultaneously rotating the cylindrical member about a longitudinal axis of the cylindrical member and moving the cylindrical member in a proximal direction with respect to the target anatomy (see col. 11, lines 26-30 – “To assist in cutting away the portion of the entrapped object extending outside of legs 17, 170, 270, 370, elongate member 12 may be rotated relative to sheath 11 and cutting device 13 while being pulled in the proximal direction”).
Regarding claim 32, Majercak et al. teaches positioning a guidewire (GW) adjacent the target anatomy (see Figure 2); and
loading the device onto the guidewire to thereby position the cylindrical member of the device adjacent the target anatomy (see [0040] – “In use, a small incision is made on a patient, typically in the femoral artery. An access or introducer sheath is utilized to gain access to the artery via the incision. A guidewire and a guide catheter (e.g., 101) may be used to allow access of the cutting catheter 100 (or 100′) to the occlusion or lesion site, as is well known in the art and therefore needs not belabored here”).
Regarding claim 33, Benning et al. teaches applying suction to a sheath that is removably positioned over at least a portion of the elongated hollow tube and at least a portion of the cylindrical member to thereby remove the biopsy sample from the cylindrical member (see [0037] – “In another example, the band 124 may be a substantially hollow wire having one or more holes (not shown) disposed on its surface. This arrangement may facilitate additional capabilities, such as irrigation, aspiration, medication delivery, or lubrication, before, during, or after the cutting process”). Majercak et al. also teaches applying suction to a sheath that is removably positioned over at least a portion of the elongated hollow tube and at least a portion of the cylindrical member to thereby remove the biopsy sample from the cylindrical member (see [0023] – “Control handle 200 is provided with a trigger arm 202, control switch 203 (for motor 300), saline inlet port 204, and an aspiration outlet 206 connected to a vacuum source that may have a pressure regulator to control the aspiration rate of plaque debris previously dislodged by the cutting catheter device 100”).
Regarding claim 34, Asselin et al. teaches the target anatomy comprises a bile duct (see col. 6, lines 29-31 – “For example, retrieval assembly 14 may have dimensions adapted for placement in a biliary duct having a particular size”).
Allowable Subject Matter
Claim 10 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Response to Arguments
Applicant’s arguments with respect to the claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Instead, Applicant’s arguments are directed to the newly added subject matter of the amended claims, which is addressed in the new grounds of rejection as outlined above.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEVIN B HENSON whose telephone number is (571)270-5340. The examiner can normally be reached M-F 7 AM ET - 5 PM ET.
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/DEVIN B HENSON/ Primary Examiner, Art Unit 3791
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