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 .
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-10 and 12-17 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.
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) 1-5, 12, and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schulz (US Patent Application Publication 20190254904) in view of Rousseau (French Patent 2732213) further in view of Broens (US Patent Application Publication 20110185506) further in view of Aboujaoude (US Patent 20120318278).
Regarding claim 1,
Schulz teaches a limb positioning system for positioning and maintaining immobilized a limb of a patient in a desired position with respect to a surgical table during orthopedic surgery, said system comprising: a pivoting member (Figure 5; 106) having a longitudinal portion extending along a corresponding longitudinal axis, said pivoting member being configured such that, when the system is in a normal use configuration, said longitudinal axis is parallel to the surgical table (Figure 1; 106 as shown (unnumbered but shown)); a support hooking member (Figure 3; end of 104 which holds 104a) configured to support the limb of the patient; and an annular part below the longitudinal portion (Figure 4; bottom of 104a as shown), the annular part movably connected to the longitudinal portion through the support part and configured to hang the limb from the longitudinal portion (Figure 1; as shown) said support member comprises a support hooking part (Figure 3; hook at the end of 104, holding 104a) connected to said longitudinal portion and movable along said longitudinal axis (Figure 3; 104 can be adjusted to bring the hooking portion further or closer to 100 through the connection between 100 and 104); a clutch (Figure 7b; 116a/b) connected to the pivoting member (Figure 7b, 118 is connected to the pivoting member 106 through 120, Examiner also Notes Paragraph 81: “In at least one embodiment, the horizontal rod 106 can formed as part of the strut 120 or clamp housing.”) having an open configuration and a locked configuration, wherein, in the open configuration, the clutch enables pivoting of the pivoting member around a rotation axis that is parallel to the longitudinal axis, distinct from the longitudinal axis, and wherein, in the locked configuration, the clutch allows immobilization of the pivoting member in the desired position (Paragraph 55 and Figure 7b; 118’s axis of rotation which is shown in parallel with the axis of 106); and at least one fixation member (Figure 7b; 116c/d) configured to maintain the system in position with respect to the surgical table.
Schulz does not teach the support hooking part is movable along said longitudinal portion and when the limb of the patient is in the desired position, the rotation axis is aligned with an anatomic rotation center of the limb of the patient, the annular part surrounds the limb at a location between the anatomic rotation center and a joint of the limb, and the pivoting member is pivoted about the rotation axis to a location such that the joint of the limb is elevated from the surgical table above the longitudinal portion.
Rousseau teaches the support hooking part is movable along said longitudinal portion (Figure 2; 10 moves along 5 by telescoping which is analogous to the support hooking part (10) and longitudinal portion (5)).
Accordingly, it would have been obvious to one of ordinary skill in the art before the invention was effectively filed to have combined Schulz (directed to a positioning device for patient limbs) and Rosseau (directed to a positioning device for patient limbs including a transverse holder adjustment) and arrived at a positioning device for patient limbs including a transverse holder adjustment. One of ordinary skill in the art would have been motivated to make such a combination to free “the surgeon from any external intervention, while allowing him to perfectly control the angle of flexion of the joint” as taught in Rosseau (Section 3).
Schulz and Rosseau do not teach when the limb of the patient is in the desired position, the rotation axis is aligned with an anatomic rotation center of the limb of the patient.
Broens teaches when the limb of the patient is in the desired position, the rotation axis is aligned with an anatomic rotation center of the limb of the patient (Figures 2 and 8; 21, see also Paragraphs 10 and 11 which discuss aligning the rotation axis of the patient hip joint to be rotated with the rotation axis of the frame joint).
Accordingly, it would have been obvious to one of ordinary skill in the art before the invention was effectively filed to have combined Schulz (directed to a positioning device for patient limbs) and Rosseau (directed to a positioning device for patient limbs including a transverse holder adjustment) and Broens (directed to a patient limb positioning device with axis of rotation alignment) and arrived at a positioning device for patient limbs including a transverse holder adjustment and axis of rotation alignment. One of ordinary skill in the art would have been motivated to make such a combination to prevent great forces applied to and potential dislocation of the patient joint as taught in Broens (Paragraphs 4-8).
Schulz as modified does not teach the annular part surrounds the limb at a location between the anatomic rotation center and a joint of the limb, and the pivoting member is pivoted about the rotation axis to a location such that the joint of the limb is elevated from the surgical table above the longitudinal portion.
Aboujaoude teaches the annular part surrounds the limb at a location between the anatomic rotation center and a joint of the limb, and the pivoting member is pivoted about the rotation axis to a location such that the joint of the limb is elevated from the surgical table above the longitudinal portion (Figure 1; see piece holding the calf above the ankle (between the rotation portion of the thigh and the joint of the ankle), where the ankle is able to be elevated above longitudinal portion which is equivalent to the portion which that holding piece is mounted on. See also Figure 2; at 260/270).
Accordingly, it would have been obvious to one of ordinary skill in the art before the invention was effectively filed to have combined Schulz (directed to a positioning device for patient limbs) and Rosseau (directed to a positioning device for patient limbs including a transverse holder adjustment) and Broens (directed to a patient limb positioning device with axis of rotation alignment) and Aboujaoude (directed to a patient limb positioning device with a support member which can rotate about the longitudinal portion) and arrived at a positioning device for patient limbs including a transverse holder adjustment and axis of rotation alignment and a rotational support member attachment. One of ordinary skill in the art would have been motivated to make such a combination to allow for the “ability to rotate the distal aspect of the limb during distraction or compression.” (Aboujaoude Paragraph 8)
Regarding claim 2, Schulz does not teach the pivoting member is movable relative to the clutch for varying a distance between the longitudinal axis and the rotation axis. Rousseau teaches the pivoting member is movable relative to the clutch for varying a distance between the longitudinal axis and the rotation axis (Figure 2; 7, 8 are vertically adjustable and analogous to the arm 120 of Schulz). Accordingly, it would have been obvious to one of ordinary skill in the art before the invention was effectively filed to have combined Schulz (directed to a positioning device for patient limbs) and Rosseau (directed to a positioning device for patient limbs including a vertical adjustment of the pivoting member) and arrived at a positioning device for patient limbs including vertical adjustment of the pivoting member. One of ordinary skill in the art would have been motivated to make such a combination to free “the surgeon from any external intervention, while allowing him to perfectly control the angle of flexion of the joint” as taught in Rosseau (Section 3).
Regarding claim 3, Schulz teaches the fixation member is configured to clamp the system to the surgical table (Paragraph 55; Figure 7b 116 and see also Figure 3; bottom of 100).
Regarding claim 4, Schulz teaches the fixation member is configured to clamp the system to the surgical table (Paragraph 55; Figure 7b 116 and see also Figure 3; bottom of 100).
Regarding claim 5, Schulz teaches the fixation member comprises a setting module configured to modify the position of the pivoting member, the support member and the clutch in a plane orthogonal to the rotation axis (Paragraph 55; Figure 7b 116 and see also Figure 3; bottom of 100).
Regarding claim 12, Schulz teaches the support hooking part is detachably connected to the annular part so that the annular part is detachable from the longitudinal portion (Figure 3; the end of 104 is detachable connected to 104a as shown).
Regarding claim 14, Schulz teaches a switching member (Figure 7b; 118) for switching the clutch between the open configuration and locked configuration, said switching member being located below the rotation axis (Figure 7b; at least a portion of 118 is located below the rotation axis, i.e. each of the four protrusions) and at a predetermined distance from the floor when the system is in a normal use configuration (Figure 3; as shown).
Claim(s) 6-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schulz (US Patent Application Publication 20190254904) in view of Rousseau (French Patent 2732213) in view of Broens (US Patent Application Publication 20110185506) further in view of Aboujaoude (US Patent 20120318278) further in view of Konsin (US Patent Application Publication 20190029906).
Regarding claim 6, Schulz, as modified, does not teach a weight compensation device configured to provide a weight compensation force to the pivoting member, said force being opposed to a weight of the limb applied to the pivoting member. Konsin teaches a weight compensation device configured to provide a weight compensation force to the pivoting member, said force being opposed to a weight of the limb applied to the pivoting member (Figure 9; 152 and Paragraph 76 describe that spring 152 biases trigger 142 to lock rotation of disk 132 (thus working against any force placed on rotatable element 132 such as weight). Accordingly, it would have been obvious to one of ordinary skill in the art before the invention was effectively filed to have combined Schulz (directed to a positioning device for patient limbs) and Rosseau (directed to a positioning device for patient limbs including a transverse holder adjustment) and Broens (directed to a patient limb positioning device with axis of rotation alignment) and Aboujaoude (directed to a patient limb positioning device with a support member which can rotate about the longitudinal portion) and Konsin (directed to a patient positioning device including a safety lockout) and arrived at a positioning device for patient limbs including a transverse holder adjustment and axis of rotation alignment and a rotational support member attachment and safety lockout. One of ordinary skill in the art would have been motivated to make such a combination because “Positioning patient supports should be performed with consideration for the safety and security of the patient.” (Konsin Paragraph 3).
Regarding claim 7, Schulz, as modified, does not teach the weight compensation device is a passive device or an active device such as an actuator. Konsin teaches the weight compensation device is a passive device (Figure 9; 152 and Paragraph 76 describe that spring 152 biases trigger 142 to lock rotation of disk 132 (thus working against any force placed on rotatable element 132 such as weight) or an active device such as an actuator (Figure 24a; 174/176 and actuator 172). Accordingly, it would have been obvious to one of ordinary skill in the art before the invention was effectively filed to have combined Schulz (directed to a positioning device for patient limbs) and Rosseau (directed to a positioning device for patient limbs including a transverse holder adjustment) and Broens (directed to a patient limb positioning device with axis of rotation alignment) and Aboujaoude (directed to a patient limb positioning device with a support member which can rotate about the longitudinal portion) and Konsin (directed to a patient positioning device including a safety lockout) and arrived at a positioning device for patient limbs including a transverse holder adjustment and axis of rotation alignment and rotational support member attachment and safety lockout. One of ordinary skill in the art would have been motivated to make such a combination because “Positioning patient supports should be performed with consideration for the safety and security of the patient.” (Konsin Paragraph 3).
Regarding claim 8, Schulz, as modified, does not teach the passive device is a spring. Konsin teaches the passive device is a spring (Figure 9; 152 and Paragraph 76 describe that spring 152 biases trigger 142 to lock rotation of disk 132 (thus working against any force placed on rotatable element 132 such as weight). Accordingly, it would have been obvious to one of ordinary skill in the art before the invention was effectively filed to have combined Schulz (directed to a positioning device for patient limbs) and Rosseau (directed to a positioning device for patient limbs including a transverse holder adjustment) and Broens (directed to a patient limb positioning device with axis of rotation alignment) and Aboujaoude (directed to a patient limb positioning device with a support member which can rotate about the longitudinal portion) and Konsin (directed to a patient positioning device including a safety lockout) and arrived at a positioning device for patient limbs including a transverse holder adjustment and axis of rotation alignment and rotational support member attachment and a safety lockout. One of ordinary skill in the art would have been motivated to make such a combination because “Positioning patient supports should be performed with consideration for the safety and security of the patient.” (Konsin Paragraph 3).
Regarding claim 9, Schulz, as modified, does not teach the active device is an actuator. Konsin teaches the active device is an actuator (Figure 24a; 174/176 and actuator 172). Accordingly, it would have been obvious to one of ordinary skill in the art before the invention was effectively filed to have combined Schulz (directed to a positioning device for patient limbs) and Rosseau (directed to a positioning device for patient limbs including a transverse holder adjustment) and Broens (directed to a patient limb positioning device with axis of rotation alignment) and Aboujaoude (directed to a patient limb positioning device with a support member which can rotate about the longitudinal portion) and Konsin (directed to a patient positioning device including a safety lockout) and arrived at a positioning device for patient limbs including a transverse holder adjustment and axis of rotation alignment and a rotational support member attachment and a safety lockout. One of ordinary skill in the art would have been motivated to make such a combination because “Positioning patient supports should be performed with consideration for the safety and security of the patient.” (Konsin Paragraph 3).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schulz (US Patent Application Publication 20190254904) in view of Rousseau (French Patent 2732213) further in view of Aboujaoude (US Patent 20120318278) in view of Broens (US Patent Application Publication 20110185506) further in view of Sugarman (US Patent 4428571).
Regarding claim 10, Schulz, as modified, does not teach a bone grasping support having a first portion fixed to the pivoting member and comprising, at one end of a second portion, a grasping member configured to be rigidly fixed to at least one bone of the patient. Sugarman teaches a bone grasping support (Figure 1; 16) having a first portion fixed to the pivoting member (Figure 1; 24 is attached at a portion analogous to the pivoting member of the combination and comprising, at one end of a second portion, a grasping member (Figure 1; 35) configured to be rigidly fixed to at least one bone of the patient. Accordingly, it would have been obvious to one of ordinary skill in the art before the invention was effectively filed to have combined Schulz (directed to a positioning device for patient limbs) and Rosseau (directed to a positioning device for patient limbs including a transverse holder adjustment) and Broens (directed to a patient limb positioning device with axis of rotation alignment) and Aboujaoude (directed to a patient limb positioning device with a support member which can rotate about the longitudinal portion) and Sugarman (directed to a patient positioning device including a grasping member) and arrived at a positioning device for patient limbs including a transverse holder adjustment and axis of rotation alignment and rotational support member attachment and grasping member. One of ordinary skill in the art would have been motivated to make such a combination “to mechanically hold the limb, particularly the leg, in the optimum position for performing surgery thereon” (Sugarman Column 1; lines 7-10).
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schulz (US Patent Application Publication 20190254904) in view of Rousseau (French Patent 2732213) in view of Broens (US Patent Application Publication 20110185506) further in view of Aboujaoude (US Patent 20120318278) further in view of Hiratsuka (US Patent Application Publication 20180289575).
Regarding claim 13, Schulz, as modified, does not teach the clutch is an electromagnetic power off brake. Hiratsuka teaches the clutch is an electromagnetic power off brake (Paragraphs 77-78 describe providing electromagnetic brakes on rotatable joints). Accordingly, it would have been obvious to one of ordinary skill in the art before the invention was effectively filed to have combined Schulz (directed to a positioning device for patient limbs) and Rosseau (directed toa positioning device for patient limbs including a transverse holder adjustment) and Broens (directed to a patient limb positioning device with axis of rotation alignment) and Aboujaoude (directed to a patient limb positioning device with a support member which can rotate about the longitudinal portion) and Hiratsuka (directed to a patient positioning device including an electromagnetic power off brake) and arrived at a positioning device for patient limbs including a transverse holder adjustment and axis of rotation alignment and a rotational support member attachment and an electromagnetic power off brake. One of ordinary skill in the art would have been motivated to make such a combination to allow the positioning of the joints to be maintained by turning on the electromagnetic breaks (Hiratsuka Paragraph 77), as well as to allow for automated operation of the system and ease use.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schulz (US Patent Application Publication 20190254904) in view of Rousseau (French Patent 2732213) in view of Broens (US Patent Application Publication 20110185506) further in view of Aboujaoude (US Patent 20120318278)further in view of Branch (US Patent Application Publication 20180333318).
Regarding claim 15, Schulz, as modified, does not teach the switching member comprises two switches located respectively on both sides of the fixation member. Branch teaches the switching member comprises two switches (Figure 16; 107 and 109/111) located respectively on both sides of the fixation member (Figure 16; the fixation member is analogous to pinch blocks 97; see also Paragraph 109 “In using the locking mechanism 83 to fix the location of the positioning system 53, a clinician may step down on the locking pedal 109 of either of the pedal assemblies 107” and Paragraph 105 “the clinician can operate the locking mechanism 83 from either side of the RKT apparatus.” Examiner notes that adopting the two pedal system of Branch would allow the pedals to be located on either side of the bed, such that someone on the opposite side of the bed from the fixation members position shown in Figure 1 of Schulz (i.e., someone adjacent the raised limb in figure 1 of Schulz) could operate to slide the fixation member without moving around the bed, as shown and described in Branch). Accordingly, it would have been obvious to one of ordinary skill in the art before the invention was effectively filed to have combined Schulz (directed to a positioning device for patient limbs) and Rosseau (directed to a positioning device for patient limbs including a transverse holder adjustment) and Broens (directed to a patient limb positioning device with axis of rotation alignment) and Aboujaoude (directed to a patient limb positioning device with a support member which can rotate about the longitudinal portion) and Branch (directed to a positioning system with dual side pedal unlocking) and arrived at a positioning device for patient limbs including a transverse holder adjustment and axis of rotation alignment and a rotational support member attachment and dual side pedal unlocking. One of ordinary skill in the art would have been motivated to make such a combination so that “the clinician can operate the locking mechanism 83 from either side of the ... apparatus” (Branch Paragraph 105).
Claim(s) 16 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schulz (US Patent Application Publication 20190254904) in view of Rousseau (French Patent 2732213) in view of Broens (US Patent Application Publication 20110185506) further in view of Aboujaoude (US Patent 20120318278) further in view of Kang (US Patent Application Publication 20140188129).
Regarding claim 16, Schulz, as modified, does not teach a surgical robotic device, wherein the limb positioning system and robotic device are connected to each other's. Kang teaches a surgical robotic device (Figure 1; 6, 14, 18, 20, 22), wherein the limb positioning system and robotic device are connected to each other (Figure 1; 6, 14, 18, 20, 22 are a robotic arm for surgical positioning attached to a thigh and foot positioner at 2, 4). Accordingly, it would have been obvious to one of ordinary skill in the art before the invention was effectively filed to have combined Schulz (directed to a positioning device for patient limbs) and Rosseau (directed to a positioning device for patient limbs including a transverse holder adjustment) and Broens (directed to a patient limb positioning device with axis of rotation alignment) and Aboujaoude (directed to a patient limb positioning device with a support member which can rotate about the longitudinal portion) and Kang (directed to a positioning system with an attached robotic device) and arrived at a positioning device for patient limbs including a transverse holder adjustment and axis of rotation alignment and a rotational support member attachment and an attached robotic device. One of ordinary skill in the art would have been motivated to make such a combination so that “The user can easily and effectively maintain or adjust the position of the patient's joint using the motorized joint positioner described herein, which may increase efficiency in the doctor's office or operating room” (Kang Paragraph 4).
Regarding claim 17, Schulz, as modified, does not teach the surgical robotic device comprises at least one movable member configured to pivot around a rotation axis coinciding with the rotation axis of the pivoting member of the limb positioning system. Kang teaches the surgical robotic device comprises at least one movable member configured to pivot around a rotation axis coinciding with the rotation axis of the pivoting member of the limb positioning system (Figure 1; 6, 14, 18, 20, 22 are a robotic arm for surgical positioning attached to a thigh positioner at 2, 4 which pivots around the axis of rotation of the pivoting member (at 6). When applied to the combination of Schulz, the pivoting joint 6 would be the rotation axis of the pivoting member (or the pivoting axis of 118 in Figure 7b of Schulz)). Accordingly, it would have been obvious to one of ordinary skill in the art before the invention was effectively filed to have combined Schulz (directed to a positioning device for patient limbs) and Rosseau (directed toa positioning device for patient limbs including a transverse holder adjustment) and Broens (directed to a patient limb positioning device with axis of rotation alignment) and Aboujaoude (directed to a patient limb positioning device with a support member which can rotate about the longitudinal portion) and Kang (directed to a positioning system with an attached robotic device) and arrived at a positioning device for patient limbs including a transverse holder adjustment and axis of rotation alignment and a rotational support member attachment and an attached robotic device. One of ordinary skill in the art would have been motivated to make such a combination so that “The user can easily and effectively maintain or adjust the position of the patient's joint using the motorized joint positioner described herein, which may increase efficiency in the doctor's office or operating room” (Kang Paragraph 4).
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 MORGAN J MCCLURE whose telephone number is (571)270-0362. The examiner can normally be reached Tuesdays 12pm-10pm and Thursdays 12pm-10pm.
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/MORGAN J MCCLURE/Examiner, Art Unit 3673
/Matthew Troutman/Supervisory Patent Examiner, Art Unit 3679