Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 21-35, 44 and 45 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Shoham (US 2012/0143084) in view of Haider et al. (US 2008/0009697).
Regarding claim 21, Shoham discloses a system for treating tissue during a medical procedure, the system comprising: an instrument (10; Figure 1) adapted to be manually supported and moved by a user, the instrument including a hand-held portion (11; Figure 1), a cutting tool (13; ¶[0037]) movably coupled to the hand-held portion (Figures 1-2; ¶[0036]-[0038]), a plurality of actuators (14 or 34) operatively coupled to the cutting tool for moving the cutting tool in a plurality of degrees of freedom relative to the hand-held portion (Figure 2; ¶[0033]), and a tracking device (2 or 4) for tracking the instrument (¶[0035]); a navigation system (6) for determining a position of the cutting tool relative to a plane associated with the tissue being treated (¶[0035]); and a control system (8) in communication with the actuators to control the actuators to move the cutting tool relative to the hand-held portion (¶[0036]-[0038]); the control system configured to establish a home position of the cutting tool relative to the hand-held portion and track deviation of the cutting tool from the home position as the cutting tool moves in one or more of the plurality of degrees of freedom relative to the hand-held portion (¶[0036]-[0039]; any position along the predetermined path can be considered as a home position as claimed since any deviation from the allowed pose, even when not moving along the path, would be corrected by the control system).
Shoham fails to explicitly disclose that the cutting tool comprises a saw. However, Shoham discloses that saws are known in the art for cutting or shaping bone (¶[0002]) and that the cutting tool is intended to shape bone (¶[0032], [0034]).
Haider et al. disclose the similar system above and further disclose using a saw (100 or 510) for shaping bone (¶[0147]).
It would have been obvious to one of ordinary skill in the art at the time of Applicant’s invention and in view of Haider et al. to have provided the cutting tool of Shoham as a saw in order to take advantage of this known means for performing Shoham’s intended task of cutting or shaping bone.
Shoham fails to disclose a display in communication with the navigation system for indicating the position of the saw blade relative to the plane; wherein the display indicates a deviation of the saw blade from a home position, a position of the saw blade and the plane. Shoham discloses providing an operator with a warning if the cutting tool is moved into an unwanted position (¶[0039]).
However, Haider et al. disclose a display (85) in communication with a navigation system for indicating the position of the saw blade relative to a tissue target which graphically warns an operator if the blade is positioned in an area outside of the target to avoid damaging unintended tissue (¶[0097], [0122]).
It would have been obvious to one of ordinary skill in the art at the time of Applicant’s invention to have provided the display, and associated software, of Haider et al. with the system of Shoham in order to graphically warn an operator if the blade is positioned in an area outside of the target to avoid damaging unintended tissue. Since Applicant’s display does not comprise any special software or circuitry to indicate the position of the saw blade relative to the plane or indicate a deviation of the saw blade from a home position, a position of the saw blade and the plane (published application - ¶[0159]-[0161]), the display provided in view of Haider et al., being capable of displaying these claimed features, is readable by the claim.
Regarding claim 22, the plurality of actuators are configured to move the saw blade in a plurality of degrees of freedom relative to the hand-held portion to orientate the saw blade to the plane (Figures 1-2; ¶[0036]-[0038] of Shoham).
Regarding claim 23, the display provided in view of Haider et al. would be capable of showing a virtual representation of a femur and the saw blade if supplied with the appropriate signals from a computer. Applicant has not disclosed any software or circuitry within the display that would enable this and appears to rely on data received from an external computer (published application - ¶[0159]-[0161]).
Regarding claim 24, the plurality of actuators are configured to correct for deviations in alignment of the saw blade as cutting is underway by changing a pitch or a roll of the saw blade (Figures 1-2; ¶[0036]-[0038] of Shoham).
Regarding claims 25-27, Shoham fails to disclose that the control system is configured to maintain a level of a speed of the saw blade as long as deflection of the saw blade is within a set percentage of a maximum cumulative deflection. However, Haider et al. disclose a control system which attenuates the cutting speed of a saw blade (and provides at least one of an aural and a tactile feedback signal to the user) if it is moved away from an intended target by a set percentage in order to avoid damaging unintended tissue (¶[0034], [0142]; thereby maintaining the cutting speed as claimed). Therefore, in order to avoid damaging unintended tissue, it would have been obvious to one of ordinary skill in the art at the time of Applicant’s invention and in view of Haider to have configured the control system as claimed. It is noted that an ability to track or measure the deflection is not required by the claims.
Regarding claim 28, the display is configured to indicate when an amount of acceptable deviation of the saw blade in a pitch direction or a roll direction is decreasing.
Regarding claim 29, the system further comprises a patient tracking device (2 of Shoham) mounted to a bone (18) and registered to the navigation system (¶[035]), and wherein the patient tracking device is configured to be registered to the navigation by touching several points on a surface of the bone (a further registration or modification to the registration could be made as claimed). Shoham fails to disclose that the bone is a femur. However, Haider et al. disclose cutting or milling a femur using a similar tool and tracking device (¶[0050], [0052], [0071]). It would have been obvious to one of ordinary skill in the art at the time of Applicant’s invention to have placed the tracking device of Shoham on a femur as a suitable bone taught by the prior art for performing guided bone cutting or milling.
Regarding claim 30, the display is configured to display portions of bone to be removed in one color and to display material to remain in a different color (capable of this function - see remarks in regard to claim 23).
Regarding claim 31, Shoham discloses a system for treating tissue during a medical procedure, the system comprising: an instrument (10; Figure 1) adapted to be manually supported and moved by a user, the instrument including a hand-held portion (11), a cutting tool (13) movably coupled to the hand-held portion (Figures 1-2; ¶[0036]-[0038]), a plurality of actuators (14 or 34) operatively coupled to the cutting tool for moving the saw blade in a plurality of degrees of freedom relative to the hand-held portion (Figures 1-2; ¶[0033]), and a tracking device (2 or 4) for tracking the instrument; a navigation system (6) for determining a position of the cutting tool relative to a virtual boundary associated with the tissue being treated; and a control system (8) in communication with the actuators to control the actuators to move the saw blade relative to the hand-held portion (¶[0036]-[0038]); the control system configured to establish a home position of the cutting tool relative to the hand-held portion and track deviation of the cutting tool from the home position as the cutting tool moves in one or more of the plurality of degrees of freedom relative to the hand-held portion (¶[0036]-[0039]; any position along the predetermined path can be considered as a home position as claimed since any deviation from the allowed pose, even when not moving along the path, would be corrected by the control system).
Shoham fails to explicitly disclose that the cutting tool comprises a saw. However, Shoham discloses that saws are known in the art for cutting or shaping bone (¶[0002]) and that the cutting tool is intended to shape bone (¶[0032], [0034]).
Haider et al. disclose the similar system above and further disclose using a saw (100 or 510) for shaping bone (¶[0147]).
It would have been obvious to one of ordinary skill in the art at the time of Applicant’s invention and in view of Haider et al. to have provided the cutting tool of Shoham as a saw in order to take advantage of this known means for performing the Shoham’s intended task of cutting or shaping bone.
Shoham fails to disclose a display in communication with the navigation system for indicating the position of the saw blade relative to the virtual boundary wherein the display is configured to indicate adjustments to the user to locate and orientate the hand-held portion of instrument such that the virtual boundary is within the adjustment range of where the instrument is capable of adjusting to locate and orientate the saw blade relative to the virtual boundary. Shoham discloses providing an operator with a warning if the cutting tool is moved into an unwanted position (¶[0039]).
However, Haider et al. disclose a display (85) in communication with a navigation system for indicating the position of the saw blade relative to a tissue target which graphically warns an operator if the blade is positioned in an area outside of the target to avoid damaging unintended tissue (¶[0097], [0122]).
It would have been obvious to one of ordinary skill in the art at the time of Applicant’s invention to have provided the display, and associated software, of Haider et al. with the system of Shoham in order to graphically warn an operator if the blade is positioned in an area outside of the target to avoid damaging unintended tissue. Since Applicant’s display does not comprise any special software or circuitry to perform the claimed functions and appears to rely completely on data supplied by an external computer (published application - ¶[0159]-[0161]), the display provided in view of Haider et al., being capable of displaying these claimed features, is readable by the claim.
Regarding claim 32, Shoham fails to disclose that the control system can attenuate the cutting speed of the saw blade when it deviates from a first position. However, Haider et al. disclose a control system which attenuates the cutting speed of a saw blade if it is moved away from an intended target or first position in order to avoid damaging unintended tissue (¶[0034], [0142]). Therefore, in order to avoid damaging unintended tissue, it would have been obvious to one of ordinary skill in the art at the time of Applicant’s invention and in view of Haider to have configured the control system as claimed.
Regarding claim 33, the system comprises one or more sensors (29 of Shoham) capable of monitoring an extent to which the saw blade has deviated from a first position (¶[0040]).
Regarding claim 34, the display is configured to show a virtual representation of a femur and the saw blade; and wherein the display screen is configured to indicate a deviation of the saw blade relative to a first position (capable of this function - see remarks in regard to claim 23).
Regarding claim 35, the display is configured to provide a translation marker, the translation marker indicative of a deviation of a distal tip of the saw blade from a first position (capable of this function - see remarks in regard to claim 23).
Regarding claims 44 and 45, any generic computer display (as provided in view of Haider et al.) would be capable of performing the claimed function under the command of an appropriate control system.
Allowable Subject Matter
Claim 43 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Response to Arguments
Applicant's arguments filed January 13th 2026 have been fully considered but they are not persuasive. Applicant has argued that Haider et al. fails to disclose a cutting blade which can be controlled by a control system as claimed because it is fixed to the handle. The above rejection only incorporates the saw blade and display from Haider et al.; not the fixed coupling of the saw blade to its handle. Applicant has argued that Shoham et al. fail to disclose a control system as claimed. As explained above, if the instrument of Shoham et al. were held stationary while the surgical tool is deflected too far from the intended pose (or home position) using the actuators, a visual alarm would be sent to the user. The display provided from Haider et al., acting as the visual alarm, would be capable of indicating this deviation as claimed.
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 Thomas McEvoy whose telephone number is (571) 270-5034 and direct fax number is (571) 270-6034. The examiner can normally be reached on Monday-Friday, 9:00 am – 6:00 pm.
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/THOMAS MCEVOY/Primary Examiner, Art Unit 3771
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