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 Objections
Claim 2 is objected to because of the following informalities: In Line 2, the word --cutting-- should be added before the word “window”. Appropriate correction is required.
Claim 3 is objected to because of the following informalities: In Line 3, the words --at least one-- should be added before the word “cutting”. Appropriate correction is required.
Claim 8 is objected to because of the following informalities and should be amended as follows: “wherein during the first interval, the rotary member is configured to rotateduring the second interval, the rotary member is configured to rotate
Claim 11 is objected to because of the following informalities: In Line 2, the words --at least one cutting-- should be added before the word “window”. Appropriate correction is required.
Claim 13 is objected to because of the following informalities: In Line 2, the word --biased-- should be added before the word “alternating”. Appropriate correction is required.
Claim 15 is objected to because of the following informalities: In Line 2, the word --the-- should be added before the word “second”. Appropriate correction is required.
Claim 19 is objected to because of the following informalities and should be amended as follows: “wherein during the first interval, the rotary member is configured to rotateduring the second interval, the rotary member is configured to rotate
Claim 20 is objected to because of the following informalities: In Lines 11 & 13, the word --cutting-- should be added before the word “window”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 4, 11, 14, 15, & 17 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 4 at Lines 1-2 recites the limitation “wherein the frequency of the alignment is adjusted based on an aspiration setting of the rotary surgical apparatus.” There is insufficient antecedent basis for “the frequency of the alignment” since this claim depends from Claim 1. Claims 2 & 3 previously recite “a frequency of an alignment” and “an alignment frequency” but it is unclear which Claim 4 is intended to depend from. For purposes of examination, the claim is being interpreted as “wherein a frequency of an alignment between the at least one window and the opening is adjusted based on an aspiration setting of the rotary surgical apparatus.” Appropriate correction is required.
Claim 11 at Line 2 recites the limitations “the first rotation angle” and “the second rotation angle”. There is insufficient antecedent basis for these two limitations in the claim since this claim depends from Claim 1. Claim 8 previously recites “a first rotation angle” and “a second rotation angle” but it is unclear if Claim 11 is intended to depend from Claim 8, 9 or 10, or not. For purposes of examination, the claim is being interpreted as “a first rotation angle of the rotary member” and “a second rotation angle of the rotary member”. Appropriate correction is required.
Claim 14 recites “wherein the controller an absolute rotational position of the rotary member is not monitored in controlling the motor in the biased alternating sequence.” which renders the claim indefinite as it is unclear what is being recited in this limitation and the specification does not further clarify in order to ascertain what the claim is reciting. For purposes of examination, the limitation is being interpreted as “wherein a rotational position of the rotary member is not monitored in controlling the motor in the biased alternating sequence”. Appropriate correction is required.
Claim 15 recites “wherein the controller adjusts the rotational position in the first direction and second direction without regard adjusting an absolution rotational position of the rotary member or the motor.” which renders the claim indefinite as it is unclear what is being recited in this limitation and the specification does not further clarify in order to ascertain what the claim is reciting. It is unclear how the controller can adjust the rotational position of the rotary member without adjusting a rotational position of the rotary member. It is further unclear what “an absolution rotational position” is. Furthermore, there is insufficient antecedent basis for the term “the rotational position” since this claim depends from Claim 1. Appropriate correction is required.
Claim 17 recites “the rotary surgical apparatus”. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, the limitation is being interpreted as “the arthroscopic surgical tool”. Appropriate correction is required.
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.
Claim(s) 1-3, 5-16 & 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hayes et al. (US PG Pub No. 2014/0277040) in view of Luedi (US PG Pub No. 2022/0167996).
Regarding Claims 1, 5-6, & 8-10, Hayes et al. discloses a rotary surgical apparatus (tool 10, Figs. 1-14, Paragraphs [0038-0062]) comprising: an outer housing (tubular housing element 32, Fig. 3, Paragraph [0042]) forming an interior passage (lumen through 32, Figs. 2 & 4) extending from an engagement end portion (end adj proximal hub 34, Fig. 4) to an acting end portion (end adj 66, Fig. 4, Paragraph [0045]), the outer housing forming an opening (window 67, Figs. 13-14, Paragraph [0045]) along the acting end portion (Fig. 4); a rotary member (33, Fig. 4, Paragraph [0042]) extending through the interior passage (Figs. 2-4) and in connection with a motor (motor 15, Fig. 1, Paragraph [0039]) at a proximal end portion (hub 80 & drive 81, Figs. 3-4, Paragraph [0046])) and forming at least one cutting window (pair of windows/openings 107 & 108, Figs. 5-6 & 11-12, Paragraph [0048]) at a distal end portion (at tip/distal end 105 of cutting head 100, Figs. 11-12), wherein the rotary member rotates within the interior passage selectively positioning the at least one cutting window relative to the opening (Paragraphs [0051, 0055-0056]); and a controller (control unit, Paragraphs [0055-0056]) in communication with the motor (via cable 18, Paragraph [0055]), wherein the controller is configured to control the motor to rotate the rotatory member in an alternating sequence (oscillation mode between forward/clockwise and reverse/counter clockwise, Paragraph [0059]) between a first direction (forward/clockwise, see arrow in Fig. 14, Paragraph [0056]) and a second direction (reverse/counter clockwise, Paragraph [0057]) opposite the first direction (The cutting element 33 is controlled by a control unit (not shown) connected to the handpiece cable 18, which control unit supplies electrical power to the motor 15 of the handpiece 11 in order to actuate the cutting element 33. Control unit also controls the mode of operation of the cutting element 33, for example by controlling motor 15 so as to drive cutting element 33 in a forward or reverse direction, or in an oscillating manner. Paragraph [0055]), wherein the controller activates the motor to drive the rotary member in the first direction for a first interval (specific number of forward/clockwise cycles, Paragraph [0059]) and the second direction for a second interval (specified number of reverse/counter clockwise cycles) (“The cutting accessory 12 may also be used in the oscillation mode, wherein the cutting element 33 is rotated a specified number of 360 degree cycles in a forward direction before reversing and rotating a specified number of 360 degree cycles in the opposite or reverse direction.” Paragraph [0059]), wherein during the first interval, the rotary member is configured to rotate over a first rotation angle (360 degrees cycles, Paragraph [0059]) and during the second interval, the rotary member is configured to rotate over a second rotation angle (360 degree cycles, Paragraph [0059]).
Hayes et al. does not disclose wherein the alternating sequence is a biased alternating sequence, wherein the first interval is greater than the second interval, and wherein the first rotation angle is at least 10% and at least 50% greater than the second rotation angle, wherein the biased alternating sequence is selectively activated alternatively with a balanced alternating sequence, and wherein the controller controls the motor to rotate the rotary member in approximately equal intervals in the first direction and the second direction in the balanced alternating sequence.
Hayes et al. does disclose in Paragraph [0059] that “The cutting accessory 12 may also be used in the oscillation mode, wherein the cutting element 33 is rotated a specified number of 360 degree cycles in a forward direction before reversing and rotating a specified number of 360 degree cycles in the opposite or reverse direction.” Hayes further discloses a second embodiment of the tool in Figs. 15-22 that is generally similar to the tool 10 (Paragraph [0063]), except only a single cutting window is provided in the cutting head 200 of the second embodiment (Paragraph [0063]), wherein the cutting head may be driven in forward and reverse modes and in oscillating mode (Paragraphs [0067-0068]), wherein “The cutting head 200 may also be driven in the oscillating mode which allows the surgeon to specify a number of forward cycles and a number of reverse cycles for the cutting head 200. In this regard, due to the alignment of the teeth and straight-edged portions of the cutting head 200 as described above, when the cutting head 200 is first driven in the forward mode (for example as indicated by the directional arrow in FIG. 22) for a specified number of rotational cycles, the teeth 214 may leave ragged or grooved tissue in the area(s) where cut. However, when the cutting head 200 is subsequently driven in the reverse mode (for example, in a direction opposite from the arrow in FIG. 22), any ragged or grooved tissue areas adjacent the housing tube window 167 will be cut by the straight-edged portions 217 on the opposite side 212 of the window 207 which will effectively clean up and the ragged or grooved areas of tissue so as to leave a smooth-finish cut.” Furthermore, Paragraph [0010] states “As such, the arrangement according to the invention reduces the number of surgical accessories that are needed during a surgery to achieve the desired result, and accordingly minimizes the need to remove the surgical accessory from the patient and then from the handpiece in order to replace same with another surgical accessory, all of which can save time during a procedure, promote safety during the procedure and reduce overall equipment costs.”
Luedi discloses a rotary surgical cutting apparatus (10, Figs. 1-5, Paragraphs [0028-0058]) comprising a proximal housing (handle portion, Fig. 2A), a motor (22, Paragraph [0031]), an outer tube (40), and an inner rotary member (50, Fig. 2A) configured to oscillate between forward and reverse directions to cut bone and other tissue at a surgical access site (Paragraph [0028]), wherein the rotary member is configured to be driven at different frequencies or at different degrees of rotation, wherein the dissection head can be configured “to rotate just one or two degrees, or more than two degrees, such as 5 degrees or more, 10 degrees or more, 15 degrees or more, 30 degrees or more, 45 degrees or more, 90 degrees or more, 120 degrees or more, 180 degrees or more, 360 degrees or more, 720 degrees or more, etc., before reversing and rotating fully back to the initial position, such that the dissection head alternates rotating an equal number of degrees in each direction (clockwise and counterclockwise).” “The frequency for a given procedure can be chosen depending on numerous factors, including the character of the bone, the geometry of the tip, the angle of displacement or contact with the target surface, the rotational speed of the dissection head, etc.” (Paragraph [0037]) “Considering the limitations of the procedure to be performed, the optimum range of rotation can be determined, as at operation 306. Like frequency, the optimum range of rotation can depend on any of the limitations of the procedure, or other considerations as well. For example, a procedure which must be completed rapidly or involves a target with little surrounding tissue in danger of becoming entangled with the dissection head can be performed using a large range of rotation, e.g., 360 degrees of rotation between reversals. In another example, the target can be porous or have other characteristics which make the target prone to unintended fractures, or the target can be surrounded by tissue which is very likely to be become entangled with the dissection head, such as nerves or blood vessels, in which case the procedure can be performed using a relatively small range of motion, e.g., 60 degrees of rotation between reversals. In embodiments, the optimum frequency and the optimum range of rotation can be chosen together, as one can impact the other. …the device can be configured such that the range of rotation can be varied, such as by adjusting a dial or other control” (Paragraphs [0053-0054, 0056]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the controller of Hayes et al. so that the alternating sequence is biased between the first and second directions, wherein the first interval is greater than the second interval, and the first rotation angle is greater than the second rotation angle by at least 10% or by at least 50%, wherein the biased alternating sequence is selectively activated alternatively with a balanced alternating sequence, and wherein the controller controls the motor to rotate the rotary member in approximately equal intervals in the first direction and the second direction in the balanced alternating sequence, as taught by Leudi based on a patient’s anatomy and particular needs, the specific surgical site, and the surgeon’s preference in order to achieve a desired surgical outcome.
Regarding Claims 2-3, the combination of Hayes et al. and Luedi discloses the claimed invention as stated above in claim 1, and Hayes et al. further discloses wherein a frequency of an alignment between the at least one cutting window and the opening (when the lower window 108 of the cutting element 33 aligns with window 67, and when the upper window 107 aligns with window 67, Paragraph [0056]) is maintained over a plurality of cycles of the biased alternating sequence by controlling a relative rotational position of the rotary member (Paragraph [0056]) (based on a constant rotational speed of 33), and wherein the controller controls a ratio of the first interval to the second interval (Paragraphs [0004, 0055])(and Paragraphs [0053-0054, 0056] of Luedi), thereby controlling an alignment frequency between the at least one cutting window and the opening (“Thus, with a single rotation of the cutting element 33 through 360 degrees within the outer housing tube 32, two types of cuts are provided, the first type of which occurs via the scissoring action between the tooth 114/straight-edged portion 115 (of the window 107) and the opposed edge 70 after the tooth 114 grabs tissue and pulls same into the window 67, and the second type of which occurs via the subsequent scissoring action between the straight-edged portion 133 (of the window 108) and the edge 70 which serves to provide a finishing or smoothing cut. Further, during rotation of the cutting element 33 in the direction indicated by the arrow in FIG. 14, the tooth 132 of the lower cutting window 108, when the housing tube window 67 opens due to its alignment with lower cutting window 108, will act in the same manner as described above with respect to tooth 114 and thus will pull tissue towards the edge 70 of the housing tube window 67. Any grooving or raggedness left in the tissue by tooth 132 will thus be cleaned up or finished by the straight-edged portion 115 of the upper window 107 when same again aligns with housing tube window 67.” Paragraph [0056]).
Regarding Claim 7, the combination of Hayes et al. and Luedi discloses the claimed invention as stated above in claim 1, and Hayes et al. further discloses wherein the biased alternating sequence is activated in response to a user input to a user interface of the controller (“The cutting element 33 is controlled by a control unit (not shown) connected to the handpiece cable 18, which control unit supplies electrical power to the motor 15 of the handpiece 11 in order to actuate the cutting element 33. Control unit also controls the mode of operation of the cutting element 33, for example by controlling motor 15 so as to drive cutting element 33 in a forward or reverse direction, or in an oscillating manner. If cutting of tissue is desired, then the motor 15 is activated so as to cause the cutting element 33 to rotate within and relative to the outer housing element 32. In this regard, it will be appreciated that the control unit may include appropriate control buttons so as to allow the surgeon or operator to select the desired accessory operations. These control functions of the cutting element 33 may alternatively be performed directly from the handpiece 11 which would then include the appropriate control buttons thereon. Alternatively, the control unit may be associated with a switch, either through a suitable cable or wirelessly, to allow the surgeon to operate the controls remotely. Such a switch may be a footswitch or a hand switch.”, Paragraph [0055]).
Regarding Claim 11, the combination of Hayes et al. and Luedi discloses the claimed invention as stated above in claim 1, and Hayes et al. further discloses a rotation difference between a first rotation angle (when each forward/clockwise cycle is 360 degrees, Paragraph [0059]) and a second rotation angle (when each reverse/counter clockwise cycle is 360 degrees, Paragraph [0059]) causes the at least one cutting window to align with the opening at a controlled frequency (“Thus, with a single rotation of the cutting element 33 through 360 degrees within the outer housing tube 32, two types of cuts are provided, the first type of which occurs via the scissoring action between the tooth 114/straight-edged portion 115 (of the window 107) and the opposed edge 70 after the tooth 114 grabs tissue and pulls same into the window 67, and the second type of which occurs via the subsequent scissoring action between the straight-edged portion 133 (of the window 108) and the edge 70 which serves to provide a finishing or smoothing cut. Further, during rotation of the cutting element 33 in the direction indicated by the arrow in FIG. 14, the tooth 132 of the lower cutting window 108, when the housing tube window 67 opens due to its alignment with lower cutting window 108, will act in the same manner as described above with respect to tooth 114 and thus will pull tissue towards the edge 70 of the housing tube window 67. Any grooving or raggedness left in the tissue by tooth 132 will thus be cleaned up or finished by the straight-edged portion 115 of the upper window 107 when same again aligns with housing tube window 67.”, Paragraph [0056]).
Regarding Claim 12, the combination of Hayes et al. and Luedi discloses the claimed invention as stated above in claim 1, and Hayes et al. further discloses wherein a rotational start position of the rotary member for each successive rotation in the first direction or the second direction is controlled relative to a rotation end position of a previous rotation (the start position of a single rotation of the cutting element 33 through 360 degrees within the outer housing tube 32 would begin immediately following the end position of the previous rotation, Paragraph [0056]).
Regarding Claim 13, the combination of Hayes et al. and Luedi discloses the claimed invention as stated above in claim 1, and Hayes et al. further discloses wherein the motor controls successive rotations of the alternating biased sequence based on a relative position control (“These control functions of the cutting element 33 may alternatively be performed directly from the handpiece 11 which would then include the appropriate control buttons thereon. Alternatively, the control unit may be associated with a switch, either through a suitable cable or wirelessly, to allow the surgeon to operate the controls remotely. Such a switch may be a footswitch or a hand switch.”, Paragraph [0055]).
Regarding Claim 14, the combination of Hayes et al. and Luedi discloses the claimed invention as stated above in claim 1, and Hayes et al. further discloses wherein a rotational position of the rotary member is not monitored in controlling the motor in the biased alternating sequence (33 does not need be directly visually monitored by a surgeon in order to set the rotational direction via the controls, Paragraph [0055]).
Regarding Claim 15, the combination of Hayes et al. and Luedi discloses the claimed invention as stated above in claim 1, and Hayes et al. further discloses wherein the controller adjusts a rotational position of the rotary member in the first direction and in the second direction (Paragraph [0059]).
Regarding Claims 16, 18 & 19, Hayes et al. discloses a method for controlling an arthroscopic surgical tool (tool 10, Figs. 1-14, Paragraphs [0038-0062]) comprising a rotary member (33, Fig. 4, Paragraph [0042]) with a cutting window (pair of windows/openings 107 & 108, Figs. 5-6 & 11-12, Paragraph [0048]) that selectively aligns rotationally with an opening (window 67 of tubular housing element 32, Figs. 3, 13-14, Paragraphs [0042, 0045]), the method comprising: rotating the rotary member in a first direction (forward/clockwise, see arrow in Fig. 14, Paragraph [0056]) over a first interval (specific number of forward/clockwise cycles, Paragraph [0059]); and rotating the rotary member in a second direction (reverse/counter clockwise, Paragraph [0057]), opposite the first direction, over a second interval (specified number of reverse/counter clockwise cycles), and wherein a ratio of the first interval to the second interval controls an alignment frequency between the cutting window and the opening (when the lower window 108 of the cutting element 33 aligns with window 67, and when the upper window 107 aligns with window 67, Paragraph [0056]) (based on the “specified number of 360 degree cycles in a forward direction before reversing and rotating a specified number of 360 degree cycles in the opposite or reverse direction.”, Paragraph [0059]); wherein a rotational start position of the rotary member for each successive rotation in the first direction or the second direction is controlled relative to a rotation end position of a previous rotation (the start position of a single rotation of the cutting element 33 through 360 degrees within the outer housing tube 32 would begin immediately following the end position of the previous rotation, Paragraph [0056]); and wherein during the first interval, the rotary member is configured to rotate over a first rotation angle and during the second interval, the rotary member is configured to rotate over a second rotation angle.
Hayes et al. does not disclose wherein the first interval is greater than the second interval, and wherein the first rotation angle is at least 10% greater than the second rotation angle.
Hayes et al. does disclose in Paragraph [0059] that “The cutting accessory 12 may also be used in the oscillation mode, wherein the cutting element 33 is rotated a specified number of 360 degree cycles in a forward direction before reversing and rotating a specified number of 360 degree cycles in the opposite or reverse direction.” Hayes further discloses a second embodiment of the tool in Figs. 15-22 that is generally similar to the tool 10 (Paragraph [0063]), except only a single cutting window is provided in the cutting head 200 of the second embodiment (Paragraph [0063]), wherein the cutting head may be driven in forward and reverse modes and in oscillating mode (Paragraphs [0067-0068]), wherein “The cutting head 200 may also be driven in the oscillating mode which allows the surgeon to specify a number of forward cycles and a number of reverse cycles for the cutting head 200. In this regard, due to the alignment of the teeth and straight-edged portions of the cutting head 200 as described above, when the cutting head 200 is first driven in the forward mode (for example as indicated by the directional arrow in FIG. 22) for a specified number of rotational cycles, the teeth 214 may leave ragged or grooved tissue in the area(s) where cut. However, when the cutting head 200 is subsequently driven in the reverse mode (for example, in a direction opposite from the arrow in FIG. 22), any ragged or grooved tissue areas adjacent the housing tube window 167 will be cut by the straight-edged portions 217 on the opposite side 212 of the window 207 which will effectively clean up and the ragged or grooved areas of tissue so as to leave a smooth-finish cut.” Furthermore, Paragraph [0010] states “As such, the arrangement according to the invention reduces the number of surgical accessories that are needed during a surgery to achieve the desired result, and accordingly minimizes the need to remove the surgical accessory from the patient and then from the handpiece in order to replace same with another surgical accessory, all of which can save time during a procedure, promote safety during the procedure and reduce overall equipment costs.”
Luedi discloses a rotary surgical cutting apparatus (10, Figs. 1-5, Paragraphs [0028-0058]) comprising a proximal housing (handle portion, Fig. 2A), a motor (22, Paragraph [0031]), an outer tube (40), and an inner rotary member (50, Fig. 2A) configured to oscillate between forward and reverse directions to cut bone and other tissue at a surgical access site (Paragraph [0028]), wherein the rotary member is configured to be driven at different frequencies or at different degrees of rotation, wherein the dissection head can be configured “to rotate just one or two degrees, or more than two degrees, such as 5 degrees or more, 10 degrees or more, 15 degrees or more, 30 degrees or more, 45 degrees or more, 90 degrees or more, 120 degrees or more, 180 degrees or more, 360 degrees or more, 720 degrees or more, etc., before reversing and rotating fully back to the initial position, such that the dissection head alternates rotating an equal number of degrees in each direction (clockwise and counterclockwise).” “The frequency for a given procedure can be chosen depending on numerous factors, including the character of the bone, the geometry of the tip, the angle of displacement or contact with the target surface, the rotational speed of the dissection head, etc.” (Paragraph [0037]) “Considering the limitations of the procedure to be performed, the optimum range of rotation can be determined, as at operation 306. Like frequency, the optimum range of rotation can depend on any of the limitations of the procedure, or other considerations as well. For example, a procedure which must be completed rapidly or involves a target with little surrounding tissue in danger of becoming entangled with the dissection head can be performed using a large range of rotation, e.g., 360 degrees of rotation between reversals. In another example, the target can be porous or have other characteristics which make the target prone to unintended fractures, or the target can be surrounded by tissue which is very likely to be become entangled with the dissection head, such as nerves or blood vessels, in which case the procedure can be performed using a relatively small range of motion, e.g., 60 degrees of rotation between reversals. In embodiments, the optimum frequency and the optimum range of rotation can be chosen together, as one can impact the other. …the device can be configured such that the range of rotation can be varied, such as by adjusting a dial or other control” (Paragraphs [0053-0054, 0056]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the method of Hayes et al. so that the first interval is greater than the second interval and the first rotation angle is greater than the second rotation angle by at least 10% as taught by Leudi based on a patient’s anatomy and particular needs, the specific surgical site, and the surgeon’s preference in order to achieve a desired surgical outcome.
Regarding Claim 20, Hayes et al. discloses a rotary surgical apparatus (tool 10, Figs. 1-14, Paragraphs [0038-0062]) comprising: an outer housing (tubular housing element 32, Fig. 3, Paragraph [0042]) forming an interior passage (lumen through 32, Figs. 2 & 4) extending from an engagement end portion (end adj proximal hub 34, Fig. 4) to an acting end portion (end adj 66, Fig. 4, Paragraph [0045]), the outer housing forming an opening (window 67, Figs. 13-14, Paragraph [0045]) along the acting end portion (Fig. 4); a rotary member (33, Fig. 4, Paragraph [0042]) extending through the interior passage (Figs. 2-4) and in connection with a motor (motor 15, Fig. 1, Paragraph [0039]) at a proximal end portion (hub 80 & drive 81, Figs. 3-4, Paragraph [0046])) and forming at least one cutting window (pair of windows/openings 107 & 108, Figs. 5-6 & 11-12, Paragraph [0048]) at a distal end portion (at tip/distal end 105 of cutting head 100, Figs. 11-12), wherein the rotary member rotates within the interior passage selectively positioning the at least one cutting window relative to the opening (Paragraphs [0051, 0055-0056]); and a controller (control unit, Paragraphs [0055-0056]) in communication with the motor (via cable 18, Paragraph [0055]), wherein the controller is configured to: control the motor to position the rotary member over a first angular range (via oscillation mode in the forward/clockwise direction, see arrow in Fig. 14)(“The cutting accessory 12 may also be used in the oscillation mode, wherein the cutting element 33 is rotated a specified number of 360 degree cycles in a forward direction before reversing and rotating a specified number of 360 degree cycles in the opposite or reverse direction.”, Paragraph [0059]) overlapping the at least one window with the opening (when the lower window 108 of the cutting element 33 aligns with window 67, and when the upper window 107 aligns with window 67, Paragraph [0056]) in a first cutting sequence (“specified number of 360 degree cycles” in the forward/clockwise direction, Paragraphs [0056-0057, 0059]); control the motor to position the rotary member over a second angular range (via oscillation mode in the reverse/counter clockwise direction)(“The cutting accessory 12 may also be used in the oscillation mode, wherein the cutting element 33 is rotated a specified number of 360 degree cycles in a forward direction before reversing and rotating a specified number of 360 degree cycles in the opposite or reverse direction.”, Paragraph [0059]) overlapping the at least one window with the opening (when the lower window 108 of the cutting element 33 aligns with window 67, and when the upper window 107 aligns with window 67, Paragraph [0056]) in a second cutting sequence (“specified number of 360 degree cycles” in the reverse/counter clockwise direction, Paragraphs [0056-0057, 0059]).
Hayes et al. does not disclose the controller configured to selectively adjust a duty cycle between the first cutting sequence and the second cutting sequence.
Hayes et al. does disclose in Paragraph [0059] that “The cutting accessory 12 may also be used in the oscillation mode, wherein the cutting element 33 is rotated a specified number of 360 degree cycles in a forward direction before reversing and rotating a specified number of 360 degree cycles in the opposite or reverse direction.” Hayes further discloses a second embodiment of the tool in Figs. 15-22 that is generally similar to the tool 10 (Paragraph [0063]), except only a single cutting window is provided in the cutting head 200 of the second embodiment (Paragraph [0063]), wherein the cutting head may be driven in forward and reverse modes and in oscillating mode (Paragraphs [0067-0068]), wherein “The cutting head 200 may also be driven in the oscillating mode which allows the surgeon to specify a number of forward cycles and a number of reverse cycles for the cutting head 200. In this regard, due to the alignment of the teeth and straight-edged portions of the cutting head 200 as described above, when the cutting head 200 is first driven in the forward mode (for example as indicated by the directional arrow in FIG. 22) for a specified number of rotational cycles, the teeth 214 may leave ragged or grooved tissue in the area(s) where cut. However, when the cutting head 200 is subsequently driven in the reverse mode (for example, in a direction opposite from the arrow in FIG. 22), any ragged or grooved tissue areas adjacent the housing tube window 167 will be cut by the straight-edged portions 217 on the opposite side 212 of the window 207 which will effectively clean up and the ragged or grooved areas of tissue so as to leave a smooth-finish cut.” Furthermore, Paragraph [0010] states “As such, the arrangement according to the invention reduces the number of surgical accessories that are needed during a surgery to achieve the desired result, and accordingly minimizes the need to remove the surgical accessory from the patient and then from the handpiece in order to replace same with another surgical accessory, all of which can save time during a procedure, promote safety during the procedure and reduce overall equipment costs.”
Luedi discloses a rotary surgical cutting apparatus (10, Figs. 1-5, Paragraphs [0028-0058]) comprising a proximal housing (handle portion, Fig. 2A), a motor (22, Paragraph [0031]), an outer tube (40), and an inner rotary member (50, Fig. 2A) configured to oscillate between forward and reverse directions to cut bone and other tissue at a surgical access site (Paragraph [0028]), wherein the rotary member is configured to be driven at different frequencies or at different degrees of rotation, wherein the dissection head can be configured “to rotate just one or two degrees, or more than two degrees, such as 5 degrees or more, 10 degrees or more, 15 degrees or more, 30 degrees or more, 45 degrees or more, 90 degrees or more, 120 degrees or more, 180 degrees or more, 360 degrees or more, 720 degrees or more, etc., before reversing and rotating fully back to the initial position, such that the dissection head alternates rotating an equal number of degrees in each direction (clockwise and counterclockwise).” “The frequency for a given procedure can be chosen depending on numerous factors, including the character of the bone, the geometry of the tip, the angle of displacement or contact with the target surface, the rotational speed of the dissection head, etc.” (Paragraph [0037]) “Considering the limitations of the procedure to be performed, the optimum range of rotation can be determined, as at operation 306. Like frequency, the optimum range of rotation can depend on any of the limitations of the procedure, or other considerations as well. For example, a procedure which must be completed rapidly or involves a target with little surrounding tissue in danger of becoming entangled with the dissection head can be performed using a large range of rotation, e.g., 360 degrees of rotation between reversals. In another example, the target can be porous or have other characteristics which make the target prone to unintended fractures, or the target can be surrounded by tissue which is very likely to be become entangled with the dissection head, such as nerves or blood vessels, in which case the procedure can be performed using a relatively small range of motion, e.g., 60 degrees of rotation between reversals. In embodiments, the optimum frequency and the optimum range of rotation can be chosen together, as one can impact the other. …the device can be configured such that the range of rotation can be varied, such as by adjusting a dial or other control” (Paragraphs [0053-0054, 0056]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the controller of Hayes et al. to selectively adjust a duty cycle between the first cutting sequence and the second cutting sequence as taught by Leudi based on a patient’s anatomy and particular needs, the specific surgical site, and the surgeon’s preference in order to achieve a desired surgical outcome.
Claim(s) 4 & 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hayes et al. (US PG Pub No. 2014/0277040) in view of Luedi (US PG Pub No. 2022/0167996) as applied to Claims 1 & 16 above and further in view of Berman et al. (US Patent No. 5,733,298).
Regarding Claim 4 as best understood, the combination of Hayes et al. and Luedi discloses the claimed invention as stated above in claim 1, except wherein a frequency of an alignment between the at least one cutting window and the opening is adjusted based on an aspiration setting of the rotary surgical apparatus. Hayes et al. does disclose in Paragraphs [0046 & 0061] that “Drive shaft 88 defines therein a suction passage 89 which is in communication with a suction port 90 defined in the neck 85, which suction port 90 is in turn in communication with the suction passage 20 of handpiece 11.” “If desirable or necessary, suction can be provided at the surgical site by manipulating the valve 22 on handpiece 11 to draw surgical debris from the surgical site through the window 67 of the housing element 32 and the window 107 or 108 of the cutting element 32 aligned therewith, into the drive shaft suction passage 89, into the handpiece suction passage 20 and proximally through the handpiece 11 towards the suction pump.”
Berman et al. discloses a rotary surgical cutting apparatus (100, Fig. 3) comprising a handpiece (102) controlled by a controller (104), an cannulated outer housing (120) comprising a distal opening (126) at the distal/acting end, and a rotary member (110) extending through the cannulated outer housing and comprising a cutting window (116 )(Fig. 4), wherein “Handpiece 102 comprises a body 140 having a conventional motor means 142 joined by cable 144 to control system 104. Control system 104 comprises, in addition to conventional subassemblies required to operate the shaver blade assembly, a window control circuit 150 which is responsive to sensor 132 in order to provide suitable signals to motor control 152 to drive the motor output so as to position inner member 114 as desired. Activation of control system 104 to stop the inner member in a desired position may be achieved by an "aspirate" button 38 on control panel 14 or on foot switch 12. As shown in Fig. 4, the inner and outer openings 116 and 126 may be stopped fully open, i.e. in alignment, to maximize the lumen aperture. Any size opening is achievable between fully open and fully closed. One may envision numerous configurations adapted to achieve the goals of the present invention. One such system is disclosed in the co-pending parent application hereof (incorporated by reference). For example, the control system may continually monitor the position of the inner member so that at any point in time when a signal is received to stop the motor, the control system may delay the actual stop (by no more than one rotation) until the sensor on the inner member is directly opposite the indicator means. Alternatively, the control system may simply monitor the position of the indicator means once per revolution so that when a stop signal is received, the motor speed could be automatically decreased from several thousand rpm to a very slow speed on the order to 1-10 rpm so that upon the next occurrence of the indicator means being opposite the sensor means the motor could be immediately automatically stopped. The control system could also be adapted to work with a stepper motor and to count motor pulses per revolution so the motor could be stopped when desired, either automatically when a certain reference point is reached or manually under visualization of the lumen aperture through an arthroscope (endoscope). (10) While the preferred embodiment disclosed has been presented in the form of a rotatable system, it should be understood that the invention is adaptable to other systems in which the inner member moves relative to the outer in some other fashion (e.g. reciprocal motion). It would be advantageous to control the position at which the motion of the inner member is stopped so that the size of the aperture could be controlled to improve the efficiency of aspiration during those times when the surgeon wants to use the shaver assembly for aspiration only. Such control would also enable the inner member to be stopped in a closed position to prevent aspiration and permit use of the shaver as a simple probe, thus limiting the need to use other instruments.”
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the controller of the combination to adjust an alignment frequency between the at least one cutting window and the opening based on an aspiration setting of the apparatus as taught by Berman et al. in order to control the size of the at least one cutting window to improve or decrease aspiration through the at least one cutting window/opening as needed during a procedure.
Regarding Claim 17 as best understood, the combination of Hayes et al. and Luedi discloses the claimed invention as stated above in claim 16, except wherein the alignment frequency is adjusted based on an aspiration setting of the arthroscopic surgical tool. Hayes et al. does disclose in Paragraphs [0046 & 0061] that “Drive shaft 88 defines therein a suction passage 89 which is in communication with a suction port 90 defined in the neck 85, which suction port 90 is in turn in communication with the suction passage 20 of handpiece 11.” “If desirable or necessary, suction can be provided at the surgical site by manipulating the valve 22 on handpiece 11 to draw surgical debris from the surgical site through the window 67 of the housing element 32 and the window 107 or 108 of the cutting element 32 aligned therewith, into the drive shaft suction passage 89, into the handpiece suction passage 20 and proximally through the handpiece 11 towards the suction pump.”
Berman et al. discloses a rotary surgical cutting apparatus (100, Fig. 3) comprising a handpiece (102) controlled by a controller (104), an cannulated outer housing (120) comprising a distal opening (126) at the distal/acting end, and a rotary member (110) extending through the cannulated outer housing and comprising a cutting window (116 )(Fig. 4), wherein “Handpiece 102 comprises a body 140 having a conventional motor means 142 joined by cable 144 to control system 104. Control system 104 comprises, in addition to conventional subassemblies required to operate the shaver blade assembly, a window control circuit 150 which is responsive to sensor 132 in order to provide suitable signals to motor control 152 to drive the motor output so as to position inner member 114 as desired. Activation of control system 104 to stop the inner member in a desired position may be achieved by an "aspirate" button 38 on control panel 14 or on foot switch 12. As shown in Fig. 4, the inner and outer openings 116 and 126 may be stopped fully open, i.e. in alignment, to maximize the lumen aperture. Any size opening is achievable between fully open and fully closed. One may envision numerous configurations adapted to achieve the goals of the present invention. One such system is disclosed in the co-pending parent application hereof (incorporated by reference). For example, the control system may continually monitor the position of the inner member so that at any point in time when a signal is received to stop the motor, the control system may delay the actual stop (by no more than one rotation) until the sensor on the inner member is directly opposite the indicator means. Alternatively, the control system may simply monitor the position of the indicator means once per revolution so that when a stop signal is received, the motor speed could be automatically decreased from several thousand rpm to a very slow speed on the order to 1-10 rpm so that upon the next occurrence of the indicator means being opposite the sensor means the motor could be immediately automatically stopped. The control system could also be adapted to work with a stepper motor and to count motor pulses per revolution so the motor could be stopped when desired, either automatically when a certain reference point is reached or manually under visualization of the lumen aperture through an arthroscope (endoscope). (10) While the preferred embodiment disclosed has been presented in the form of a rotatable system, it should be understood that the invention is adaptable to other systems in which the inner member moves relative to the outer in some other fashion (e.g. reciprocal motion). It would be advantageous to control the position at which the motion of the inner member is stopped so that the size of the aperture could be controlled to improve the efficiency of aspiration during those times when the surgeon wants to use the shaver assembly for aspiration only. Such control would also enable the inner member to be stopped in a closed position to prevent aspiration and permit use of the shaver as a simple probe, thus limiting the need to use other instruments.”
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the tool used in the method of the combination to adjust an alignment frequency between the at least one cutting window and the opening based on an aspiration setting of the apparatus as taught by Berman et al. in order to control the size of the at least one cutting window to improve or decrease aspiration through the at least one cutting window/opening as needed during a procedure.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
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/JESSICA WEISS/Primary Examiner, Art Unit 3775