DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Status of Claims
Claim(s) 1-20 is/are pending of which Claim(s) 1 and 14 is/are presented in independent form. Claims 2-3, 5-7 have been amended.
All references relied up on and not cited in the current Form 892 may be found in previous 892's or IDS'.
Response to Arguments
Applicant's arguments filed 5/22/2026 have been fully considered but they are not persuasive.
Regarding the teachings of Quaid, Applicant argues that Quaid merely provides compensating for the weight of the arm and not the tool (or limb as modified with Zahiri) placed at the end of the arm (Remarks Pages 7-9). Examiner disagrees. Quaid recites “the user perceives the arm 33 as weightless” (see [0115]), and further recites “A weightless feeling may be achieved, for example, by computing gravitational loads acting on the segments 33a, 33b, and 33c of the arm 33 and controlling motors of the haptic device 30 to counteract the gravitational loads. As a result, the user does not have to support the weight of the arm. The haptic device 30 may be in the free mode, for example, until the user is ready to direct the tool 50 to a surgical site on the patient's anatomy” wherein as shown in Fig. 2A the segment 33c includes the arm portion holding the attached “tool 50”. One of ordinary skill in the art would clearly understand that the weight of the arm 33 and in specific the arm portion 33c would include the weight of anything attached onto it further being the attached tool 50 as shown in Fig. 2A. Any force of gravity affecting that arm 33 would include the attached weight and load of the “tool 50” in order to render such a weightless feeling. In order for the user to “perceive the arm 33 as weightless” when grasping the arm, the weight of the tool at the end must be compensated for and there is nothing that would suggest otherwise. Examiner further notes that the combination of record is simply the mechanical arm of Zahiri and its method of usage with an end effector holding a surgical limb holder being modified to have the backdriveability and weightless features as taught by the analogous mechanical arm as provided by Quaid; wherein the weight and gravitational load of the arm includes anything attached onto said mechanical arm. Thus the claim language of compensating… by a mechanical arm… for weight of the limb allows a user to manually reposition the limb” and “wherein the mechanical arm is backdriveable for manipulation of the second holder by a user and compensates for weight of the patient's limb” and other related claim language is taught by the combination of Zahiri and Quaid.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Regarding extra motivation provided by Examiner of Zahiri of manual positioning improvements, Applicant argues that it does not lead one of ordinary skill in the art to the combination (Remarks Pages 7-9). Examiner disagrees. Zahiri’s desire for improved manual positioning for its mechanical arm (Col. 3 lines 50-53) would provide one of ordinary skill in the art when provided with each of the references of Zahiri and Quaid herein with push to combine them as the mechanical arm of Quaid provides improvements of manual mechanical arm positioning (Quaid [0115, 0183]). When looking at analogous arts, we are looking at both common field of inventions as well as common problems being solved. Each of Zahiri and Quaid are dealing with subject matter of mechanical arms that may be controlled by a user and each have disclosure with concerns over the problem of manual positioning and control of mechanical arms. The statement therein thus provides the context for the common problem being looked at by each of the references herein to establish analogousness. The main TSM (teaching, suggestion, motivation) is still provided by Quaid as seen in the rejection below for providing thus an improved manually controlled mechanical arm.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
In response to applicant's argument that the weightless mechanical arm of Quaid would not lead to the weightless limb in the positioner of Zahiri as combined, the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
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.
Claim 7 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 7 recites the limitation "shape or size of implant" in line 2. Claim 3 from which claim 7 now depends recites “a trial implant” wherein there is a lack of clarity on if this “implant” of claim 7 is different from or the same as the “trial implant” of claim 3. For interpretation purposes, will be read as -shape or size of a final installed implant-.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 1, 8-15, and 18-20 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Zahiri (US 5,645,079) in view of Quaid (US 20060142657 A1).
With respect to claim 1, Zahiri discloses A method of operating a joint positioner (Fig 1), comprising:
securing a first holder of the joint positioner to a first portion of a limb and a second holder of the joint positioner to a second portion of the limb (Fig 1, Fig 10 motor embodiment relied upon but as the numbering is the same Figures 1-9 are referenced), limitation step shown, first portion of the limb is the thigh in first holder 66, second portion is the ankle in second holder 82);
compensating, in a first mode by a mechanical arm extending between the first holder and the second holder, for weight of the limb while the mechanical arm is allowed to manually reposition the limb (col 9 ll 60-70, col 10 ll 25-30, using the joystick to move the apparatus motors the first mode wherein as the usage of the joystick manipulates the mechanical arms of Zahiri, the user using the joystick is manipulating the mechanical arm, movement of the limb from initial held position to an adjusted position indicates that the first mode herein being when the limb is being moved, the weight of the limb is implicitly compensated for when the leg is moved by the mechanical arm as described therein) (Fig 10, col 9 l 60-col 10 l 30, arm is free extending from the table so there is some compensation by the motors as the user manually- with the joystick- moves the leg); and
switching from the first mode to a second mode in which the mechanical arm is fixed in the position (col 9 ll 60-70, position of the leg is held in a second mode by a lock therein).
Zahiri does not disclose compensating in a first mode for weight of the limb while backdriveability of the mechanical arm allows a user to manually reposition the limb.
Examiner notes that Zahiri discloses an exact desire of also being configured to direct manual manipulation by the user (Col. 3 lines 50-53).
However, Quaid teaches an analogous mechanical arm 33 (Fig. 1 and Fig. 2A-2C) that is able to be manually held and adjusted directly by the user (Fig. 2C and [0115] and [0120]) that analogously has a holder 50 (Fig. 2A-2C and [0118, end effector 50 holds weighted tools such as “a surgical tool (such as a burr, drill, probe, saw, etc.), medical device, microscope, laser range finder, camera, light, endoscope, ultrasound probe, irrigation device, suction device, radiotherapy device, and/or any other component useful for surgery, surgical planning, and/or surgical navigation”, wherein a component useful in surgery could also be directly a limb of the surgical patient), wherein the mechanical arm 33 is built to compensate in a first mode for weight of the limb while backdriveability of the mechanical arm allows a user to manually reposition the limb ([0115, 0183] the mechanical arm 33 has backdriveability such that when being manually manipulated by the user, the user does not feel the weight thus providing improved manipulation therein).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the mechanical arm and second holder of Zahiri attached to the end of the mechanical arm therein (Fig. 1-9) to comprise the methodology of compensating in a first mode for weight of the limb while backdriveability of the mechanical arm allows a user to manually reposition the mechanical arm (and thus the limb) as taught by Quaid in order to provide easier manual repositioning as the user would not experience any of the weight of the mechanical arm or anything attached to it thereon (Quaid [0115, 0183] and Zahiri Col. 3 lines 50-53)
With respect to claim 8, Zahiri in view of Quaid discloses The method of Claim 1.
Zahiri as combined with Quaid further discloses wherein compensating, by the mechanical arm, for weight of the limb comprises fully compensating for the weight of the limb such that the limb is weightless for the user manipulating the mechanical arm (Zahiri Fig 10, col 9 l 60-col 10 l 30, arm is free extending from the table so there is some compensation by the motors as the user manually- with the joystick- moves the leg, the weight of the limb is fully held and thus compensated by the mechanical arm implicitly or else the mechanical would fall and be unfunctional, the user using the joystick to manipulate the mechanical arm would not experience any of the weight of the limb thus the limb being weightless for the use manipulating the mechanical arm) (As combined with Quaid [0115], the teachings of Quaid enable the limb to feel weightless as the mechanical arm backdriveable motors may compensate any imbalance of forces such as gravity and as a genus includes the objects at its end effector 35, which as combined with Zahiri is the limb therein).
With respect to claim 9, Zahiri in view of Quaid discloses The method of Claim 1.
Zahiri as combined with Quaid discloses wherein compensating, by the mechanical arm, for the weight of the limb comprises sensing, by the mechanical arm, incremental changes in force as a user articulates the mechanical arm and controlling actuators of the mechanical arm based on the incremental changes (Zahiri Fig 10, col 9 l 60-col 10 l 30, mechanical arm system senses changes in force to the joystick and articulates the mechanical arm to control the actuators according to those changes) (Quaid [0115, 0183] mechanical arm 33 compensates force imbalances that are sensed thereon from the weight of gravity and anything on its end effector 35 such that the actuators therein balance out the forces when the arm is used).
With respect to claim 10, Zahiri in view of Quaid discloses The method of Claim 1.
Zahiri further discloses comprising providing the second mode when a cutting tool is being operated (col 1 ll 10-25, col 9 l 60-col 10 l 30, user is manipulated then surgery commences, system is used in kneed surgery which requires at least one cut or incision by a cutting tool in order to break the skin to use the surgical tools therein).
With respect to claim 11, Zahiri in view of Quaid discloses The method of Claim 1.
Zahiri as combined with Quaid discloses wherein switching between the first mode and the second mode is performed in response to a user input requesting to fix the position of the joint positioner (Zahiri col 10 ll 20-30, response from a moving to a locked mode is responsive to the user and then the lack of user input, computer program is an example of a user input and it controls the motors from the first to the second mode, also the joystick operation by a user is an example of inputs and control the motors from the first to second mode, wherein the joystick being in a neutral position is a deliberate choice of the user using the invention of Zahiri it being an implicit act of user input requesting the joint positioner to be in a locked position) (Quaid [0132, 0182-0183] further teaches also being able to lock the mechanical arm into a particular pose being the second mode from a free mode being a first mode with free movement of the mechanical arm).
With respect to claim 12, Zahiri in view of Quaid discloses The method of Claim 1.
Zahiri discloses wherein the second portion of the limb comprises an ankle and the first portion of the limb comprises a femur (Fig 1, Fig 10, second portion is ankle brace 82 and first portion is femur brace 66).
With respect to claim 13, Zahiri in view of Quaid discloses The method of Claim 1.
Zahiri discloses wherein securing the first holder of the joint positioner to the first portion of the limb comprises strapping the first holder to the first portion of the limb (Fig 1, straps 67 of first portion 66).
With respect to claim 14, Zahiri discloses a joint positioner (Fig 10 motor embodiment relied upon but as the numbering is the same Figures 1-9 are referenced), comprising:
a first holder configured to hold a first portion of a patient's limb (Fig 1, Fig 10, first portion of the limb is the thigh in first holder 66);
a second holder configured to hold a second portion of the patient's limb (Fig 1, Fig 10, second portion is the ankle in second holder 82); and
a mechanical arm comprising arm segments extending in series between the first holder and the second holder (Fig 1, arm is device 110, segmented by the motors);
wherein:
the mechanical arm compensates for weight of the patient’s limb during manipulation by the user (col 9 ll 60-70, col 10 ll 25-30, using the joystick to move the apparatus motors the first mode wherein as the usage of the joystick manipulates the mechanical arms of Zahiri, the user using the joystick is manipulating the mechanical arm, movement of the limb from initial held position to an adjusted position indicates that the first mode herein being when the limb is being moved, the weight of the limb is implicitly compensated for when the leg is moved by the mechanical arm as described therein) (Fig 10, col 9 l 60-col 10 l 30, arm is free extending from the table so there is some compensation by the motors as the user manually- with the joystick- moves the leg).
Zahiri does not disclose the mechanical arm is backdriveable for manipulation of the second holder by a user and compensates for weight of the patient’s limb during the manipulation by the user.
Examiner notes that Zahiri discloses an exact desire of also being configured to direct manual manipulation by the user (Col. 3 lines 50-53).
However, Quaid teaches an analogous mechanical arm 33 (Fig. 1 and Fig. 2A-2C) that is able to be manually held and adjusted directly by the user (Fig. 2C and [0115] and [0120]) that analogously has a holder 50 (Fig. 2A-2C and [0118, end effector 50 holds weighted tools such as “a surgical tool (such as a burr, drill, probe, saw, etc.), medical device, microscope, laser range finder, camera, light, endoscope, ultrasound probe, irrigation device, suction device, radiotherapy device, and/or any other component useful for surgery, surgical planning, and/or surgical navigation”, wherein a component useful in surgery could also be directly a limb of the surgical patient), wherein the mechanical arm 33 is built to compensate in a first mode for weight of the limb while backdriveability of the mechanical arm allows a user to manually reposition the limb ([0115, 0183] the mechanical arm 33 has backdriveability such that when being manually manipulated by the user, the user does not feel the weight thus providing improved manipulation therein).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the mechanical arm and the second holder of Zahiri attached at the end of the mechanical arm (Fig. 1-9) to comprise the mechanical arm is backdriveable for manipulation of the second holder by a user and compensates for weight of the mechanical arm (and thus the patient’s limb) during the manipulation by the user as taught by Quaid in order to provide easier manual repositioning as the user would not experience any of the weight of the mechanical arm or anything attached to it thereon (Quaid [0115, 0183] and Zahiri Col. 3 lines 50-53)
With respect to claim 15, Zahiri in view of Quaid discloses the joint positioner of Claim 14.
Zahiri as combined with Quaid discloses wherein the joint positioner is configured to switch the mechanical arm between a first mode in which the mechanical arm allows manipulation of the second holder by the user and a second mode in which the mechanical arm is fixed in position (Zahiri Col 9 ll 60-70, col 10 ll 25-30, a moving and a non-moving mode) (Quaid [0182-0183] mechanical arm may be switched between locked and free modes).
With respect to claim 18, Zahiri in view of Quaid discloses the joint positioner of Claim 14.
Zahiri as combined with Quaid discloses comprising processing circuitry programmed to control the mechanical arm (Zahiri col 9 l 60-col 10 l 30, there is a computer 115 therein able to be programmed for fine control of the mechanical arm position) (Quaid [0183] computing processor for the mechanical arm) to compensate for weight of the patient’s limb in the first mode by sensing incremental changes in force as the user manipulates the mechanical arm (Zahiri Fig 10, col 9 l 60-col 10 l 30, arm is free extending from the table so there is some compensation by the motors as the user manually- with the joystick- moves the leg; Fig 10, col 9 l 60-col 10 l 30, mechanical arm system senses changes in force to the joystick and articulates the mechanical arm to control the actuators according to those changes)
(Quaid [0115, 0183] as combined provides mechanical arm 33 compensates force imbalances that are sensed thereon from the weight of gravity and anything on its end effector 35 such that the actuators therein balance out the forces when the arm is used).
With respect to claim 19, Zahiri in view of Quaid discloses the joint positioner of Claim 14.
Zahiri discloses wherein the mechanical arm comprises actuators and is further configured to automatically move via operation of the actuators (col 9 l 60-col 10 l 30, computer programming to move from start to secondary position).
With respect to claim 20, Zahiri in view of Quaid discloses the joint positioner of Claim 14.
Zahiri discloses wherein the second holder is an ankle holder (Fig 10, Fig 1, ankle holder 82).
Claim(s) 2, 6 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Zahiri (US 5,645,079) in view of Quaid (US 20060142657 A1) in view of Branch (US 20120046540 A1).
With respect to claim 2, Zahiri in view of Quaid discloses The method of Claim 1.
Zahiri further discloses comprising performing a stage of a surgical procedure on the limb while the mechanical arm is fixed in the position (col 9 l 65-col 10 l 5, position of the leg is held and operation occurs).
Zahiri in view of Quaid does not provide for preoperatively obtaining, by the joint positioner, a preoperative set of data relating to soft tissue balance of a joint of the limb; and obtaining, by the joint positioner after completion of the surgical procedure, a postoperative set of data relating to the soft tissue balance of the joint of the limb.
However, Branch teaches an analogous joint positioner comprising a robotic arm having a limb holder therein (Fig. 1, tibia positioning assembly 100 and foot rotation assembly 200 being limb holders being robotically controlled [0003, 0071, 0240-0241]) wherein the joint positioner herein provides the method of obtaining, by the joint positioner, a set of data relating to soft tissue balance of a joint of the limb (see [0016, 0025-0027, 0240, 0251-0253-0275] wherein the limb positioner performs automated motions for measuring the state of the ligaments of joints wherein the state of the ligaments are a set of data relating to the soft tissue balance of the limb such as knee joints placed in the positioner, taking many measurements of the state of the soft tissues and their balance of the joint limb), wherein the measurements may be obtained both preoperatively for a preoperative set of data (see [0016] measurements taken before surgery to verify knee diagnosis of the issue) and postoperatively for a postoperative set of data (see [0016] measurements taken post ligament reconstruction to verify the ligament restoration and success thereof).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the limb positioner of Zahiri/Quad with the method and invention of preoperatively obtaining, by the joint positioner, a preoperative set of data relating to soft tissue balance of a joint of the limb; and obtaining, by the joint positioner after completion of the surgical procedure, a postoperative set of data relating to the soft tissue balance of the joint of the limb as taught by Branch in order to provide an improved surgical system able to diagnose and track a ligament reconstruction surgery performed thereof (Branch [0016]).
With respect to claim 6, Zahiri in view of Quaid discloses The method of Claim 1.
Zahiri discloses further comprising automatically moving, in a third mode, the second holder relative to the first holder via operation of actuators of the mechanical arm (col 9 l 60-col 10 l 30, computer programming to move from start to secondary position where the user would then manually adjust using the joystick, wherein movement of the second holder or the first holder would always be relative one another implicitly).
Zahiri as combined does not provide thereby moving a joint of the limb through a range of motion, while collecting measurements representative of tension in the joint and providing forces or torques to the joint.
However, Branch teaches an analogous joint positioner comprising a robotic arm having a limb holder therein (Fig. 1, tibia positioning assembly 100 and foot rotation assembly 200 being limb holders being robotically controlled [0003, 0071, 0240-0241]) wherein the joint positioner herein provides moving a joint of the limb through a range of motion, while collecting measurements representative of tension in the joint and providing forces or torques to the joint (see [0016, 0025-0027, 0240, 0251-0253-0275] wherein the limb positioner performs automated motions for measuring the state of the ligaments of joints wherein the state of the ligaments are a set of data relating to the soft tissue balance of the limb such as knee joints placed in the positioner) ([0006] increased ligament length is measured which corresponds with a gap distance within a joint as a ligament crosses across a joint having a gap between the bones in a joint corresponding with a measure of tension in the joint) (tibia knee torque is measured as force being applied to the limb/joint [0071]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the limb positioner of Zahiri/Quad with the method and invention thereby moving a joint of the limb through a range of motion, while collecting measurements representative of tension in the joint and providing forces or torques to the joint as taught by Branch in order to provide an improved surgical system able to diagnose and track a state of the ligaments of a joint (Branch [0016]).
Claim(s) 3, 5, and 7 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Zahiri (US 5,645,079) in view of Quaid (US 20060142657 A1) in view of Branch (US 20120046540 A1), in further view of Bojarski (US 20110029091 A1).
With respect to claim 3, Zahiri in view of Quaid and Branch discloses the method of claim 2.
Branch as combined herein provides for the joint positioner itself being able to obtain a trial set of data relating to the soft tissue balance of the joint (see claim 2 combination above).
Zahiri in view of Quaid and Branch fails to disclose intraoperatively obtaining, by the joint positioner, a trial set of data relating to the soft tissue balance of the joint with a trial implant in place in the joint.
However, Bojarski teaches an analogous surgical method of a joint relating to a knee joint and avoiding ligament problems thereof (Abstract, surgical method of knee replacement to provide improved ligament outcomes [0023, 0091]) comprising the analogous steps of obtaining, a preoperative set of data relating to soft tissue balance of a joint of the limb (pre-operative patient specific data is obtained [0080], which may be data related to the soft tissue balance of the joint [0020, 0022]), and further provides the method step of intraoperatively obtaining (Table 8, intraoperative measurements, and [0160, 0186] intraoperative optimization and assessment) a trial set of data relating to the soft tissue balance of the joint with a trial implant in place in the joint ([0021-022, 0186, 0193] the soft tissue balance of the joint is intraoperatively obtained and optimized through usage of applying trial implants) (see [0021, 0193-0194] wherein this may be a trial set of data with trial implants).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the method of use of the joint positioner of Zahiri/Quaid/Branch to further comprise the step of intraoperatively obtaining, by the joint positioner, a trial set of data relating to the soft tissue balance of the joint with a trial implant in place in the joint as taught by Bojarski in order to enable the limb positioner system herein be able to aid in a knee replacement surgery (Bojarski [0021, 0023, 0091-00194] and provide improved outcomes therein of the ligaments of the user).
With respect to claim 5, Zahiri in view of Quaid and Branch discloses The method of claim 2.
Branch as combined teaches wherein the preoperative set of data comprises a gap distance in the joint ([0006] ligament length is measured which corresponds with a gap distance within a joint as a ligament crosses across a joint having a gap between the bones in a joint) and a force acting on the joint ([0071] tibia knee torque is measured).
Branch as combined does not explicitly provide for teaches wherein the preoperative set of data comprises a gap distance in the joint and a force acting on the joint.
Bojarski also teaches an analogous surgical method of a joint relating to a knee joint and avoiding ligament problems thereof (Abstract, surgical method of knee replacement to provide improved ligament outcomes [0023, 0091]) comprising the analogous steps of obtaining, a preoperative set of data relating to soft tissue balance of a joint of the limb (pre-operative patient specific data is obtained [0080], which may be data related to the soft tissue balance of the joint [0020, 0022]), wherein the preoperative set of data comprises a gap distance in the joint and a force acting on the joint ([0022] ligament tension/soft tissue balance obtained from measuring a medical joint gap distance and a force being tension acting on the joint).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have provided wherein the preoperative set of data comprises a gap distance in the joint and a force acting on the joint as taught by Bojarski to the combined method system of Zahiri in view of Quaid and Branch in order to provide completeness to the assessment of a user’s ligament state (Bojarski [0022]).
With respect to claim 7, Zahiri in view of Quaid and Branch and Bojarski discloses the method of Claim 3.
Branch as combined teaches measuring the tension (an analogous system of applying force to a user’s limb teaching the steps of measuring the tension [0271], measure the location and the laxity of a joint is a measure of tension at least at the start of the device use).
Bojarski as combined provides modifying the knee or choosing an alternative shape or size of implant based on the trial set of data so as to achieve a desired relationship between the preoperative set of data and the postoperative set of data (see [0186] during a knee surgery the knee may be operated on for replacement with implants wherein intraoperatively the shape and size of the implant may be altered based on trial implant data obtained thereof, see [0021] wherein trial data may influence the shape and optimization, thus achieving a relationship between data obtained preoperatively and postoperatively of the knee, further see [0084, 0114, 0186, 0193-0194]).
Claim 4 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Zahiri/Quaid in view of Horton (US 7,234,180) and Lamb (US 6,286,164).
With respect to claim 4, Zahiri in view of Quaid discloses the method of Claim 1.
Zahiri discloses wherein the first holder is coupled to and positioned at a table (Fig 1, table 12).
Zahiri/Quaid is silent on the method further comprising reorienting, by a motor, the first holder relative to the table.
However, Horton teaches an analogous series of supports having an analogous first holder and teaches method further comprising reorienting, by a motor, the first holder relative to the table (col 6 ll 30-35, col 7 ll 10-20, first holder 92a moveable along axis 100 relative to remainder of support/table 12, may be any system that can raise and lower and motors are taught to be able to suitable moving systems).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add mobility to the first holder of Zahiri/Quaid as taught by Horton in order to better orient the user (Horton col 1 ll 40-50).
Zahiri/Horton is not specific that the raising and lowering of the first member is by motor.
However, Lamb teaches raising and lowering a first member by motor (Fig 2, col 5 ll 30-40, member 16, motor 302).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a motor in the first member of Zahiri/Horton/Quaid as taught by Lamb in order to ensure cost effectiveness and proper elevation (Lamb col 1 ll 55-65).
Claim 16 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Zahiri/Quaid in view of Albu-Shaffer (US 2007/0120512).
With respect to claim 16, Zahiri/Quaid discloses the joint positioner of Claim 14.
Zahiri/Quaid is silent on wherein the arm segments are cylindrical
Albu-Shaffer teaches an analogous multi-segment robotic arm wherein the arm segments are cylindrical (Fig 1, [0040], rod shaped elements 16, a rod is a cylinder).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the segments of Zahiri/Quaid to be the cylindrical and jointed segments as taught by Albu-Shaffer in order to allow for more joints and thus more movements and positions (Albu-Shaffer [0030]).
Claim 17 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Zahiri/Quaid in view of Horton (US 7,234,180).
With respect to claim 17, Zahiri/Quaid discloses The joint positioner of Claim 14.
Zahiri discloses a table coupled to the first holder (Fig 1, table 12).
Zahiri is silent comprising and an actuator operable to reorient the first holder relative to the table.
Horton teaches an analogous series of supports comprising and an actuator operable to reorient the first holder relative to the table (col 6 ll 30-35, col 7 ll 10-20, first holder 92a moveable along axis 100 relative to remainder of support/table 12).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add mobility to the first holder of Zahiri as taught by Horton in order to better orient the user (Horton col 1 ll 40-50).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 1, 8, 9, 14, and 18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 11 and 1 of U.S. Patent No. 12,245,975 (“Kang ‘975”). Although the claims at issue are not identical, they are not patentably distinct from each other because the more limitingly claimed invention of Kang ‘975 anticipates the claimed genus in the application being examined and, therefore, a patent to the genus would improperly extend the right to exclude granted by a patent to the species or sub-genus should the genus issue as a patent after the species or sub-genus.
Instant Application
Kang ‘975
1. A method of operating a joint positioner, comprising:
securing a first holder of the joint positioner to a first portion of a limb and a second holder of the joint positioner to a second portion of the limb;
compensating, in a first mode, a mechanical arm extending between the first holder and the second holder,
for weight of the limb while backdriveability of the mechanical arm allows a user to manually reposition the limb;
switching from the first mode to a second mode in which the mechanical arm is fixed in position.
11. A method for robotically-assisted soft tissue balancing for an arthroplasty procedure, comprising:
…forces to a first holder holding a first bone of a limb a second holder holding a second bone of the limb;…
…controlling a robotic device to apply, using back driveable actuators of the robotic device, …
enabling manual repositioning of the limb of the patient by counteracting, by the forces, weight of the limb by applying the forces to the first holder and the second holder such that the limb feels weightless to a user manually repositioning the first holder and the second holder;…
(claim limitations rearranged to correspond to the matching elements of the instant application, irrelevant limitations omitted)
8. The method of Claim 1, comprising compensating, by the mechanical arm, for weight of the limb comprises fully compensating for the weight of the limb such that the limb is weightless for the user manipulating the mechanical arm.
11. … such that the limb feels weightless to a user manually repositioning the first holder and the second holder;…
(still substantially identical scope)
9. The method of Claim 1, wherein compensating, by the mechanical arm, for the weight of the limb comprises sensing, by the mechanical arm, incremental changes in force as a user articulates the mechanical arm and controlling actuators of the mechanical arm based on the incremental changes.
11. … enabling manual repositioning of the limb of the patient by counteracting, by the forces, weight of the limb by applying the forces to the first holder and the second holder such that the limb feels weightless to a user manually repositioning the first holder and the second holder;…
14. A joint positioner, comprising:
a first holder configured to hold a first portion of a patient's limb;
a second holder configured to hold a second portion of the patient's limb; and
a mechanical arm comprising arm segments extending in series between the first holder and the second holder;
the mechanical arm is backdriveable for manipulation of the second holder by a user and compensates for weight of the patient’s limb during the manipulation by the user.
1. A robot-aided knee arthroplasty system, comprising:
a robotic device comprising a first holder for holding a first portion of a limb of a patient,
a second holder for holding a second portion of the limb of the patient, and
a plurality of back driveable actuators operable to apply forces to the first holder and the second holder;
a controller communicable with the robotic device and programmed to: control the robotic device to enable manual repositioning of the limb of the patient by counteracting weight of the limb by applying the forces to the first holder and the second holder such that the limb feels weightless to a user manually repositioning the first holder and the second holder;
control the robotic device to apply an additional force configured to increase a gap distance at a joint between the first portion of the limb and the second portion of the limb; and
collect measurements of the gap distance as the robotic device applies the force.
18. The joint positioner of Claim 14, comprising processing circuitry programmed to control the mechanical arm to compensate for weight of the patient’s limb by sensing incremental changes in force caused by the manipulation of the second holder by the user.
1. … a controller communicable with the robotic device and programmed to: control the robotic device to enable manual repositioning of the limb of the patient by counteracting weight of the limb by applying the forces to the first holder and the second holder such that the limb feels weightless to a user manually repositioning the first holder and the second holder;…
Claims 2-7, 10-13, 15-17, 19-20 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 11 and 1 of U.S. Patent No. 12,245,975 (“Kang ‘975”) in view of Zahiri (US 5,645,079) and Quaid (US 20060142657 A1) and Horton (US 7,234,180) and Lamb (US 6,286,164) and Branch (US 2012/0046540) and Bojarski (US 20110029091 A1) and Albu-Shaffer (US 2007/0120512).
As seen in the rejections of claims 1-20, the cited prior art renders the claimed features (of claims 2-7, 10-13, 15-17, 19-20) novel and/or obvious as detailed above. Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have utilized such features in combination with the U.S. Patent No. 12,245,975 (“Kang ‘975”) claims for the purpose of providing a positional limb apparatus that is weightless and thus easy to move and position as needed by a surgeon near the limb positioner.
Conclusion
THIS ACTION IS MADE FINAL. 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 KEVIN S ALBERS whose telephone number is (571)272-0139. The examiner can normally be reached Monday-Friday 7:30 am to 5:00 pm.
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/KEVIN S ALBERS/Patent Examiner, Art Unit 3786
/RACHAEL E BREDEFELD/Supervisory Patent Examiner, Art Unit 3786
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