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 Amendments and Arguments
The amendments, filed December 18, 2025 have been entered. Claim 32 has been cancelled and claims 2, 8, 9, 13-21, and 29-30 have previously been cancelled. Claims 1, 6, 11, 31, and 33 have been amended. Claims 35-36 have been added. Claims 1, 3-7, 10-12, 22-28, 31, and 33-36 are currently pending in the application.
The amendments to the claims have overcome the previous rejections under 35 U.S.C. 112(b).
The Terminal Disclaimer, filed December 18, 2025, has overcome the previous nonstatutory double patenting rejection.
Applicant argues, on pages 9-10 of Applicant’s remarks, that the previously cited prior art of Bernardoni (U.S. Publication No. 2015/0231013), Mitsuishi (Patent Publication No. JP 2004348699 A) and Meyer (U.S. Patent No. 10,016,900) does not sufficiently disclose, teach, or suggest the subject matter of the brake being normally active and is electrically deactivatable in conjunction with activation of the respective electric motor as Meyer does not explicitly teach a brake. However, while Meyer is cited for its ability to apply a braking force to the motor, Bernardoni is currently and was previously cited for its disclosure of a brake 74A-C (see Bernardoni, Figures 3 and 5, paragraphs 0077-0080 where the brake comprising components 74A-C is discussed, also see paragraphs 0075 and 0081-0086 which discuss brakes - the safety switches – being applied to every drive unit). As Bernardoni teaches brakes being applied to the drive units of the positioning apparatus, it would have been well within the level of ordinary skill in the art to apply the teachings of Meyer of applying a braking force to the drive units after a period of non-use with the brakes of Bernardoni, as the brakes 74A-C are what Bernardoni utilizes to apply braking force to the drive units.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 3-7, 10-12 22-28, 31, 33, and 34 are rejected under 35 U.S.C. 103 as being unpatentable over Bernardoni (U.S. Publication No. 2015/0231013), in view of Mitsuishi (Patent Publication No. JP 2004348699 A) and further in view of Meyer (U.S. Patent No. 10,016,900).
Regarding claim 1, Bernardoni discloses a patient limb positioning apparatus 20 comprising: a coupling bracket 60 detachably engageable with the patient's limb (Figure 2 and paragraph 0070); a movement assembly 34, 62, 44 operating on the coupling bracket 60 to move the coupling bracket 60 according to a plurality of axes of movement X, Y, Z, and W (Figure 2 and paragraphs 0069, 0071, and 0074); wherein the movement assembly 5 comprises, for at least one of said axes of movement X, Y, Z, and W: a slider 35 and 45, a drive unit 34, 62, 44 activatable to move the coupling bracket 60 according to a predetermined direction of movement (Figure 2 and paragraph 0012); wherein said brake operates between the electric motor (of electric actuators 34, 62, 44) wherein at least one of said drive units 34, 62, and 44 comprises an electric motor 62, 97, 83, 102, and 104 (see Bernardoni, Figures 1 and 3 and paragraph 0110) and a brake selectively activatable to lock the position of the respective slider 35 and 45 or coupling bracket (see Bernardoni, Figures 3 and 5, paragraphs 0077-0080 where the brake comprising components 74A-C is discussed, also see paragraphs 0075 and 0081-0086 which discuss brakes - the safety switches – being applied to every drive unit).
Bernardoni does not disclose a load transducer configured to detect a load transmitted between the coupling bracket and the drive unit in the respective direction of movement, and to emit a signal representative of a detected load value; an electronic control unit operationally connected with said drive unit and with the load transducer; wherein, in a load control command mode, the electronic control unit is configured to compare the detected load value with a pre-set load value, and to command activation of the drive unit when the detected load value differs from the pre-set load value.
Mitsuishi teaches a patient limb positioning apparatus (shown in Figure 1) comprising: a coupling bracket 110 and 111 detachably engageable with the patient's limb K (Figure 1); a drive unit 62, 97, 83, 102, and 104 which can be activated activatable to move the coupling bracket 110 and 111 according to a predetermined direction of movement (paragraphs 0089 and Figure 3); a load transducer 114 configured to detect a load transmitted between the coupling bracket 110 and 111 and the drive unit 62, 97, 83, 102, and 104 in the respective direction of movement (paragraph 0022, 0088-0089, and 0102-0119 and Figure 3), and to emit a signal representative of a detected load value (paragraph 0104); an electronic control unit 113 operationally connected with said drive unit 62, 97, 83, 102, and 104 and with the load transducer 114 (paragraphs 0102-0104 and 110); wherein, in a load control command mode, the electronic control unit 113 is configured to compare the detected load value (defined by the force detected when a force is applied to a patient’s limb, see paragraphs 0109-0010) with a pre-set load value (defined by the detection reference force, paragraphs 0107-0110), and to command activation of the drive unit 62, 97, 83, 102, and 104 when the detected load value differs from the pre-set load value (paragraph 0110).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have combined Bernardoni (directed to a limb positioning apparatus) with Mitsuishi (also directed to a patient limb positioning apparatus) and arrived at a limb positioning apparatus comprising a force detection system and associated drive unit. One of ordinary skill in the art would have been motivated to do so because the drive unit of Mitsuishi provides a power assist in the positioning of a patient’s limb, thereby lowering the force required to properly position the limb for medical procedures (paragraphs 0011-0013).
Additionally, Bernardoni does not explicitly disclose wherein at least one of the said drive units comprises an electric motor, wherein said brake is normally active and is electrically deactivatable in conjunction with activation of the respective electric motor, to enable sliding of the respective slider or rotation of the coupling bracket.
Meyer teaches wherein at least one of the said drive units 115 comprises an electric motor (Col. 17, lines 40-53), wherein said brake is normally active and is electrically deactivatable in conjunction with activation of the respective electric motor, to enable sliding of the respective slider or rotation of the coupling bracket (Col. 26, line 64-Col. 27, line 9, where, when no force or little force below a certain threshold is maintained for a period of time, a braking force is applied to all motors to stop movement of the arm, but applying a force to the arm would reenable movement).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have combined Bernardoni, as modified, (directed to a limb positioning apparatus) with Meyer (directed to a force-controlled medical and surgical system) and arrived at an electrical braking system. One of ordinary skill in the art would have been motivated to do so because the electric braking system of Meyer allows for the medical device to be held in a desired position automatically upon letting go of the device without the need for additional inputs (Col. 26, line 64-Col. 27, line 9).
Regarding claim 3, Bernardoni, as modified, discloses the subject matter as discussed above with regard to claim 1. Bernardoni, as modified, further discloses wherein in the load control command mode the electronic control unit 113 is configured to reduce the difference between the detected load value (defined by the force detected when a force is applied to a patient’s limb, see Mitsuishi, paragraphs 0109-0010) and the pre-set load value (defined by the detection reference force, see Mitsuishi, paragraphs 0102-0110).
Regarding claim 4, Bernardoni, as modified, discloses the subject matter as discussed above with regard to claim 1. Bernardoni, as modified, further discloses wherein in the load control command mode the electronic control unit 113 is configured to command activation of the drive unit 62, 97, 83, 102, and 104 so as to move the coupling bracket 110 and 111 in the direction of movement (see Mitsuishi, paragraph 0110).
Regarding claim 5, Bernardoni, as modified, discloses the subject matter as discussed above with regard to claim 1. Bernardoni, as modified, further discloses wherein the electronic control unit is switchable to a load setting operating mode (defined by the mode through which foot switch 121 is depressed, see paragraph 0107 and Figure 8A) in which the electronic control unit 113 is configured to store the pre-set load value (defined by the “detection reference force”, see Mitsuishi, paragraphs 0107-0108).
Regarding claim 6, Bernardoni, as modified, discloses the subject matter as discussed above with regard to claims 1 and 5. Bernardoni, as modified, further discloses wherein the electronic control unit 113 is switchable to a load setting operating mode (see Mitsuishi, paragraph 0107) in conjunction with a command disabling a different control mode (see Mitsuishi, paragraphs 0107-0110 where the mode is enabled by pressing on switch 121).
Bernardoni, as modified, does not disclose a position control command mode in which it is configured to store a pre-set position of the coupling bracket with respect to the drive unit in the respective direction of movement, and to control activation of the drive unit when the detected position differs from the pre-set position.
Meyer teaches a position control command mode (see Meyer, Col 18, line 52-Col. 19, line 3) in which it is configured to store a pre-set position of the coupling bracket with respect to the drive unit in the respective direction of movement (see Meyer, Col 18, line 52-Col. 19, line 3), and to control activation of the drive unit when the detected position differs from the pre-set position (see Meyer, Col. 5, lines 7-21, Col. 16, lines 20-23, and Col. 19, lines 13-23 which describe pre-set poses or postures that the surgical arms may be positioned in).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have combined Bernardoni, as modified, (directed to a limb positioning apparatus) with Meyer (directed to a force-controlled medical and surgical system) and arrived at an electrical braking system. One of ordinary skill in the art would have been motivated to do so because the position transducer of Meyer would allow a caregiver to automatically put in the apparatus in predetermined positions, such as a specific alignment with a patient or a set up position, which may be useful in medical procedures (Col. 5, lines 7-21, Col. 16, lines 20-23, and Col. 19, lines 13-23).
Regarding claim 7, Bernardoni, as modified, discloses the subject matter as discussed above with regard to claim 1. Bernardoni, as modified, further discloses wherein the pre-set load value (defined by the “detection reference force”, see Mitsuishi, paragraphs 0107-0108) corresponds to the load value measured by the load transducer 114 while the drive unit 62, 97, 83, 102, and 104 holds the coupling bracket 110 and 111 in a stationary position in the direction of movement (see Mitsuishi, paragraphs 0107-0108).
Regarding claim 10, Bernardoni, as modified, discloses the subject matter as discussed above with regard to claims 1 and 5. Bernardoni, as modified, further discloses wherein in the load setting operating mode (defined by the mode through which foot switch 121 is depressed, see Mitsuishi, paragraph 0107 and Figure 8A) the electronic control unit 113 is configured to store the load value measured by the load transducer 114 while the drive unit 62, 97, 83, 102, and 104 holds the coupling bracket 110 and 111 in a stationary position in the direction of movement (see Mitsuishi, paragraphs 0107-0108).
Regarding claim 11, Bernardoni, as modified, discloses the subject matter as discussed above with regard to claim 1. Bernardoni, as modified, further discloses wherein said drive unit 62, 97, 83, 102, and 104 further comprises an electric motor 62, 97, 83, 102, and 104 (see Mitsuishi, Figures 1 and 3 and paragraph 0110) and a torque limiter 74A-C operationally interposed between the motor 62 and the coupling bracket 110 and 111 (Figures 3 and 5, paragraphs 0077-0080 where the torque limiter comprising components 74A-C is discussed, also see paragraphs 0075 and 0081-0086 which discuss torque limiters - the safety switches – being applied to every drive unit).
Regarding claim 12, Bernardoni, as modified, discloses the subject matter as discussed above with regard to claims 1 and 11. Bernardoni, as modified, further discloses wherein the load transducer 114 is operationally interposed between the torque limiter 74A-C and said coupling bracket 110 and 111 (see Mitsuishi, Figures 3 and 5 and see paragraphs 0077-0080).
Regarding claim 22, Bernardoni, as modified, discloses the subject matter as discussed above with regard to claim 1. Bernardoni, as modified, further discloses wherein the drive unit 34, 62, 44 comprises a traction drive unit 34 (see Bernardoni, Figure 2 and paragraphs 0068-0069), a rotation drive unit 62 (see Bernardoni, paragraph 0071), and an extension drive unit 44 (see Bernardoni, paragraph 0074), and the movement assembly comprises: a traction arm 30 having a proximal end 31 constrainable to an operating table (see Bernardoni, Figure 2 and paragraph 0066); a traction slider 35 movable along the traction arm 30 upon command by the traction drive unit 34 (see Bernardoni, paragraph 0069); wherein the rotation drive unit 62 is borne by the traction slider 35, and operates on said coupling bracket 60 to rotate 60 the coupling bracket around a rotation axis Y that is substantially coplanar to a traction axis X of the traction arm 30 (see Bernardoni, Figure 2 and paragraph 0070-0071); a guide column 42 rising from a base 41; and an extension slider 45 constrained to a distal end 39 of the traction arm 30 and movable along the guide column 42 upon command of the extension drive unit 44 (see Bernardoni, Figure 2 and paragraphs 0072-0075).
Regarding claim 23, Bernardoni, as modified, discloses the subject matter as discussed above with regard to claims 1 and 22. Bernardoni, as modified, further discloses wherein the load transducer 114 comprises a torsional load cell 114 operationally associated with the rotation drive unit 62 (see Mitsuishi, Figure 3 and paragraph 0098).
Regarding claim 24, Bernardoni, as modified, discloses the subject matter as discussed above with regard to claims 1 and 22. Bernardoni, as modified, further discloses wherein the load transducer 114 comprises an axial load cell 114 operationally associated with the traction drive unit 97 (see Mitsuishi, Figure 3 and paragraph 0098).
Regarding claim 25, Bernardoni, as modified, discloses the subject matter as discussed above with regard to claims 1 and 22. Bernardoni, as modified, further discloses wherein the electronic control unit 113 is configured to operate in load control command mode at least on the traction axis Y and/or rotation axis R, during the movement of the extension slider 64 upon activation of the extension drive unit 83 (see Mitsuishi, paragraph 0147, where the operations of the positioning apparatus may be performed simultaneously).
Regarding claim 26, Bernardoni, as modified, discloses the subject matter as discussed above with regard to claims 1 and 22. Bernardoni, as modified, further discloses wherein the electronic control unit 113 is switchable to the load control command mode on at least the traction axis Y and/or rotation axis R, in response to the activation of the extension drive unit 83 (see Mitsuishi, paragraph 0018, where a switching means is provided to turn the driving means on or off, such that all driving units are activated simultaneously, additionally see paragraph 0147, where the operations of the positioning apparatus may be performed simultaneously, such that a force applied in more than one direction such as in the R and Z direction, the driving means would apply the power assist simultaneously).
Regarding claim 27, Bernardoni, as modified, discloses the subject matter as discussed above with regard to claims 1 and 22. Bernardoni, as modified, further discloses wherein the electronic control unit 113 is configured to operate in the load control command mode on at least the traction axis Y and/or rotation axis R, during an adduction movement wherein the base 56 and the guide column 79 translate concentrically to the proximal end 53 of the traction arm (see Mitsuishi, paragraph 0147, where the operations of the positioning apparatus may be performed simultaneously, and see Bernardoni, Figure 2 and paragraph 0066 where traction arm 30 is hinged to the operating table at proximal end 31).
Regarding claim 28, Bernardoni, as modified, discloses the subject matter as discussed above with regard to claims 1 and 22. Bernardoni, as modified, does not disclose at least one position transducer for each of said traction, rotation and extension drive units.
Meyer teaches at least one position transducer for each of said traction, rotation and extension drive units (Col. 17, line 54-Col. 18, line 3, where a position sensor is provided on each joint 113 on each arm 111).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have combined Bernardoni, as modified, (directed to a limb positioning apparatus) with Meyer (directed to a force-controlled medical and surgical system) and arrived at each drive unit comprising a position transducer. One of ordinary skill in the art would have been motivated to do so because the position transducer of Meyer would allow a caregiver to automatically put in the apparatus in predetermined positions, such as a specific alignment with a patient or a set up position, which may be useful in medical procedures (Col. 5, lines 7-21, Col. 16, lines 20-23, and Col. 19, lines 13-23).
Regarding claim 31, Bernardoni, as modified, discloses the subject matter as discussed above with regard to claims 1, 22, and 30. Bernardoni, as modified, further discloses wherein said brake operates between the electric motor (of electric actuators 34, 62, 44) and the respective slider 35 and 45 or coupling bracket (see Bernardoni, paragraphs 0075-0077).
Regarding claim 33, Bernardoni, as modified, discloses the subject matter as discussed above with regard to claims 1, 22, and 30. Bernardoni, as modified, wherein said brake 74A-C operates between the electric motor 62, 97, 83, 102, and 104 and the load transducer 114 (see Bernardoni, Figures 3 and 5, paragraphs 0077-0080 where the brake comprising components 74A-C is discussed, also see paragraphs 0075 and 0081-0086 which discuss brakes - the safety switches – being applied to every drive unit).
Regarding claim 34, Bernardoni, as modified, discloses the subject matter as discussed above with regard to claim 1. Bernardoni, as modified, further discloses a surgery method for a patient limb, comprising positioning the patient limb by the apparatus as claimed in claim 1 (see Bernardoni, paragraph 0006 and see discussion of claim 1, above).
Claim 35 is rejected under 35 U.S.C. 103 as being unpatentable over Bernardoni in view of Mitsuishi and Meyer and further in view of Koch (U.S. Publication No. 2020/0360215).
Regarding claim 35, Bernardoni, as modified, discloses the subject matter as discussed above with regard to claim 1. Bernardoni, as modified, further discloses said electric motor 62, 97, 83, 102, and 104 (see Bernardoni, Figures 1 and 3 and paragraph 0110). Bernardoni, as modified, does not explicitly disclose a stator and a shaft carrying a respective rotor, wherein said brake is attached to the stator and selectively activatable to brake the shaft carrying the respective rotor.
Koch teaches a stator 42 and a shaft 17 carrying a respective rotor 30, wherein said brake 22 is attached to the stator 42 and selectively activatable to brake the shaft 17 carrying the respective rotor 30 (Figure 3 and paragraphs 0057-0064).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have combined Bernardoni, as modified, (directed to a limb positioning apparatus) with Koch (also directed to a limb positioning apparatus and arrived at the brake being attached to a stator and a rotor. One of ordinary skill in the art would have been motivated to do so because doing so would merely amount to a simple substitution of one known element (the brake of Bernardoni) for another (the brake comprising a stator and rotor) that would not provide unexpected results, as the stator and rotor brake configuration of Koch is able to provide sufficient braking force in a patient limb positioning apparatus. In this regard, MPEP 2143(B) and KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007) are relevant.
Claim 36 is rejected under 35 U.S.C. 103 as being unpatentable over Bernardoni in view of Mitsuishi and further in view of Koch.
Regarding claim 36, Bernardoni discloses a patient limb positioning apparatus 20 comprising: a coupling bracket 60 detachably engageable with the patient's limb (Figure 2 and paragraph 0070); a movement assembly 34, 62, 44 operating on the coupling bracket 60 to move the coupling bracket 60 according to a plurality of axes of movement X, Y, Z, and W (Figure 2 and paragraphs 0069, 0071, and 0074); wherein the movement assembly 34, 44, 62 comprises, for at least one of said axes of movement X, Y, Z, and W: a slider 35 and 45; a drive unit 34, 62, 44 activatable to move the coupling bracket 60 according to a predetermined direction of movement (Figure 2 and paragraph 0012); an electric motor 62, 97, 83, 102, and 104 (see Bernardoni, Figures 1 and 3 and paragraph 0110); and a brake selectively activatable to lock the position of the respective slider 35 and 45 or coupling bracket (see Bernardoni, Figures 3 and 5, paragraphs 0077-0080 where the brake comprising components 74A-C is discussed, also see paragraphs 0075 and 0081-0086 which discuss brakes - the safety switches – being applied to every drive unit).
Bernardoni does not disclose a load transducer configured to detect a load transmitted between the coupling bracket and the drive unit in the respective direction of movement, and to emit a signal representative of a detected load value; an electronic control unit operationally connected with said drive unit and with the load transducer; wherein, in a load control command mode, the electronic control unit is configured to compare the detected load value with a pre-set load value, and to command activation of the drive unit when the detected load value differs from the pre-set load value; wherein at least one of said drive units comprises: an electric motor including a stator and a shaft carrying a respective rotor, and a brake attached to the stator and selectively activatable to lock the position of the respective slider or coupling bracket, by braking the shaft carrying the respective rotor.
Mitsuishi teaches a patient limb positioning apparatus (shown in Figure 1) comprising: a coupling bracket 110 and 111 detachably engageable with the patient's limb K (Figure 1); a drive unit 62, 97, 83, 102, and 104 which can be activated activatable to move the coupling bracket 110 and 111 according to a predetermined direction of movement (paragraphs 0089 and Figure 3); a load transducer 114 configured to detect a load transmitted between the coupling bracket 110 and 111 and the drive unit 62, 97, 83, 102, and 104 in the respective direction of movement (paragraph 0022, 0088-0089, and 0102-0119 and Figure 3), and to emit a signal representative of a detected load value (paragraph 0104); an electronic control unit 113 operationally connected with said drive unit 62, 97, 83, 102, and 104 and with the load transducer 114 (paragraphs 0102-0104 and 110); wherein, in a load control command mode, the electronic control unit 113 is configured to compare the detected load value (defined by the force detected when a force is applied to a patient’s limb, see paragraphs 0109-0010) with a pre-set load value (defined by the detection reference force, paragraphs 0107-0110), and to command activation of the drive unit 62, 97, 83, 102, and 104 when the detected load value differs from the pre-set load value (paragraph 0110); and an electric motor 62 (paragraph 0034 and 0076-0077 and Figure 5).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have combined Bernardoni (directed to a limb positioning apparatus) with Mitsuishi (also directed to a patient limb positioning apparatus) and arrived at a limb positioning apparatus comprising a force detection system and associated drive unit. One of ordinary skill in the art would have been motivated to do so because the drive unit of Mitsuishi provides a power assist in the positioning of a patient’s limb, thereby lowering the force required to properly position the limb for medical procedures (paragraphs 0011-0013).
Koch teaches a stator 42 and a shaft 17 carrying a respective rotor 30, wherein said brake 22 is attached to the stator 42 and selectively activatable to brake the shaft 17 carrying the respective rotor 30 (Figure 3 and paragraphs 0057-0064).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have combined Bernardoni, as modified, (directed to a limb positioning apparatus) with Koch (also directed to a limb positioning apparatus and arrived at the brake being attached to a stator and a rotor. One of ordinary skill in the art would have been motivated to do so because doing so would merely amount to a simple substitution of one known element (the brake of Bernardoni) for another (the brake comprising a stator and rotor) that would not provide unexpected results, as the stator and rotor brake configuration of Koch is able to provide sufficient braking force in a patient limb positioning apparatus. In this regard, MPEP 2143(B) and KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007) are relevant.
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 ALISON N LABARGE whose telephone number is (571)272-6098. The examiner can normally be reached M-F 8-4:00.
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/ALISON N LABARGE/Examiner, Art Unit 3679
/Matthew Troutman/Supervisory Patent Examiner, Art Unit 3679
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