DETAILED ACTION
This office action is responsive to the amendment and request for continued examination of October 10, 2025. The supplemental amendment of that same date is considered. Claims 21, 31, and 46 were amended; claim 47 was canceled; and claim 49 was newly presented.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Status
Examiner notes a full listing of the claims is not presented. Claims 1-20 should be indicated as ‘canceled’ in the claim listing.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114 was filed in this application after a decision by the Patent Trial and Appeal Board, but before the filing of a Notice of Appeal to the Court of Appeals for the Federal Circuit or the commencement of a civil action. Since this application is eligible for continued examination under 37 CFR 1.114 and the fee set forth in 37 CFR 1.17(e) has been timely paid, the appeal has been withdrawn pursuant to 37 CFR 1.114 and prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant’s submission filed on October 10, 2025, has been entered.
Response to Arguments
No substantive arguments are presented. The previously presented rejections are maintained, as below. The rejections stand, even in view of the amendments to the claims of October 10, 2025.
It is noted that newly presented claim 49 is indicated as including allowable subject matter.
Claim Interpretation
The claim term “end effector” is understood to be a device which is ‘intermediary between the tool and the base’. The tool is understood to be the ‘distal component which performs work on a target structure’. These understandings correlate to the disclosure of the instant application.
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) 21-23, 29, 41, 42, 44, 46 and 48 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bozung (US 2013/0060278 A1) in view of Moore, Sr. (US 4,515,504).
Regarding claim 21, Bozung teaches a surgical system, comprising:
a base 500 configured to be manipulated by a user's hand;
an end-effector 207 for mounting a surgical tool 202 ([0136], fig. 16);
an actuation unit (seen in fig.17, including pitch adjustment mechanism 312, yaw adjustment mechanism 412, and z-axis adjustment mechanism including motors 220, 222, 224, and associated transmission means, [0170], etc.) connected between the base 500 and the end-effector 207 for moving the end-effector 207, and therefore the surgical tool 202, independently, with respect to the base 500 (the actuation unit functions to move the tool 202 independent of movement of the base 500);
a tracking unit 114/116/108 configured to determine in real time a pose of any of the tool 202, the end-effector 207, and the base 500 with respect to the patient's body (all can be determined since these components are all coupled together; [0144], etc.); and
a control unit 112/120 for controlling the actuation unit of fig. 17, the control unit configured to:
determine a path of the surgical tool ([0145], [0147], [0149] – 112 determines position and orientation data of the base; 120 determines location of the tip of 202 (i.e. path of the tool);
if the path falls within a planned volume, move the end-effector 207 independently of the base 500 to keep the path within the planned volume (the controller 120, controlled by 112, causes the end effector to move [0145], [0148]); and
if the path falls outside the planned volume, determine a new pose of the base [0294], [0295], [0296].
Discussion of the “active mode” at [0297]-[0305] is considered to be of importance in relation to the instant claims.
Bozung does not teach a support unit, as claimed.
Moore teaches a drill assembly as at fig. 6, which includes a base (the handheld drill), and end effector (the drill bit), and a support unit 10. The support unit is connected solely to the base and is capable of being brought into contact with a patient’s body (analogous to the workpiece in fig. 6) to provide a partial mechanical link between the base (handheld drill) and a patient's body. The support unit comprises an elastic element (resilient, claim 1) capable of adjustably dampening a reaction force in response to at least user movement in at least one direction (inherently due to the resilience, thereof; e.g. movement pressing the drill toward the workpiece which causes 10 to deflect).
The new limitation “solely” is considered acceptable for finding support in at least the instant figures. Moore’s straps 16 attach the support unit 10 solely to the base (the body of the handheld drill).
The term “partial mechanical link” is defined in applicant’s specification to mean “a mechanical link between at least two parts, wherein a relative movement of said at least two parts in at least one degree of freedom is possible”. This is achieved as at fig. 6 of Moore where support unit 10 is capable of flexing at at least joints 26 and 27.
It would have been obvious to one with ordinary skill in the art at the time of the invention to add a support unit of Moore to the Bozung device, such as by wrapping straps 16 of Moore about the Bozung device. One would have done so in order to collect debris from a procedure carried out by the Bozung device (Moore, abstract). It is noted that during use, the Moore device 10 flexes as the drill advances (Moore, abstract). Such modification would have resulted in the end effector of the modified Bozung device extending beyond the support unit when the Moore portion 10 at least when flexed. Further, the actuation unit would move the end effector 207 independently of the support unit in such an arrangement. One would have made this modification in order to prevent material drilled by Bozung from being inadvertently released into a surgical site.
Regarding claims 22 and 23, in some situations (depending on the size the treatment area), the new pose is capable of permitting treatment of the entire volume, or an iteration of poses is capable of being implemented to treat the entire volume.
Regarding claims 29 and 42, the support unit 160 of the combination is capable of contacting an area of the patient’s body distal from a part of the patient’s body to be treated such that the support unit does no obstruct the path of the tool 202, as in Moore fig. 6. It is noted that the support is located a distance away from the tool. The interaction of the support unit with the patient is considered to be “non-invasive”.
Examiner presumes the term “distal” to be used in this case to mean “some distance away from”, rather than a “distal/proximal relationship”. If applicant argues that the Moore arrangement is not “distal”, examiner will issue a rejection under 35 USC 112(b) stating that this is an indefinite relative term.
Regarding claim 41, the support unit and the tool are at two distinct, non-parallel axes when formed as suggested. This is considered to be “off-axis” positioning. As at fig. 6 of Moore, the support unit contacts the work piece (patient’s body) at an off-axis location.
Regarding claim 44, during use, the tool 202 is capable of extending distally beyond a distal end of the support unit (e.g. upon flexing of the support unit, abstract, Moore).
Regarding claim 46, Bozung teaches a surgical system, comprising:
a handheld base 500;
an actuation unit (as seen at fig. 17, including pitch adjustment mechanism 312, yaw adjustment mechanism 412, and z-axis adjustment mechanism including motors 220, 222, 224, and associated transmission means, [0170], etc.) attached to the base 500 (all components assembled into a single assembly such that all components are attached to one another), the actuation unit configured to move a surgical tool or a tool guide independently of the base 500; and
a control unit 112/120 for controlling the actuation unit of fig. 17, the control unit configured to:
determine a path of the surgical tool [0145], [0147], [0149]: 112 determines position and orientation data of the base; 120 determines location of the tip of 202 (i.e. path of the tool);
if the path falls within a planned volume, move the actuation unit independently of the base 500 to keep the path within the planned volume (the controller 120, controlled by 112, causes the end effector to move [0145], [0148]); and
if the path falls outside the planned volume, determine a new pose of the base so that the path of the tool will reach at least a portion of the planned volume, and provide an indication of at least one direction to move the base to achieve the new pose. [0294], [0295], [0296] Discussion of the “active mode” at [0297]-[0305] is considered to be of importance in relation to the instant claims.
The new limitation “solely” is considered acceptable for finding support in at least the instant figures. Moore’s straps 16 attach the support unit 10 solely to the base (the body of the handheld drill).
Bozung does not teach a support unit, as claimed.
Moore teaches a drill assembly as at fig. 6, which includes a base (the handheld drill), and end effector (the drill bit), and a support unit 10. The support unit is connected solely to the base (handheld drill) and is capable of being brought into contact with a patient’s body (analogous to the workpiece in fig. 6) to provide a partial mechanical link between the base (handheld drill) and a patient's body. The support unit reduces degrees of freedom of movement of the base (handheld drill) while not affecting degrees of freedom of movement of the tool (due to reduction of movement of the handheld drill in various directions – rotation/tilting of the handheld drill is permitted but translation in X and Y axes is not). Note the support unit is resilient (claim 1).
The term “partial mechanical link” is defined in applicant’s specification to mean “a mechanical link between at least two parts, wherein a relative movement of said at least two parts in at least one degree of freedom is possible”. This is achieved by Hudson where support unit 10/20 is capable of movement in a horizontal direction (as by actuating screw-adjustment sleeve 48) or by permitting pivoting of the drill relative thereto.
It would have been obvious to one with ordinary skill in the art at the time of the invention to add a support unit 10 of Moore to the Bozung device, such as by wrapping straps 16 of Moore about the Bozung device. One would have done so in order to collect debris from a procedure carried out by the Bozung device (Moore, abstract). It is noted that during use, the Moore support unit 10 flexes as the drill advances (Moore, abstract). Such modification would have resulted in the end effector of the modified Bozung device extending beyond the support unit when the Moore support unit 10 at least when flexed. Further, the actuation unit would move the end effector 207 independently of the support unit in such an arrangement, such that degrees of freedom of the tool 202, itself, are not reduced by use of the support unit. One would have made this modification in order to prevent material drilled by Bozung from being inadvertently released into a surgical site.
Regarding claim 48, an end of the support unit 10 is V-shaped (as at fig. 6 of Moore; portions 11 and 12 considered to form a V about hinge 27).
Claim 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bozung (US 2013/0060278 A1) in view of Moore, Sr. (US 4,515,504) and Apkarian (US 8,511,945 B2).
Regarding claim 25, the combination suggests the limitations of claim 21 but Bozung does teach an arm which supports the base and is capable of coupling to an operating table.
Apkarian teaches a drill 600 having an unlabeled support unit as at fig. 5. The drill further includes an arm support 616 for the tool coupled to the base 600. There is no particular reason the arm base 614 could not be coupled to an operating table.
It would have been obvious to one with ordinary skill in the art at the time of the invention to provide Bozung with an articulated arm which was capable of being coupled to an operating table, and being connected to the base of the tool, as suggested by Apkarian. One would have done so in order relieve the surgeon from having to hold and support the instrument during a surgical procedure.
Claim(s) 31-36, 40, 43 and 45 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bozung (US 2013/0060278 A1) in view of Hudson (US 4,080,092).
Regarding claim 31, Bozung teaches a surgical system as at fig. 1. The system includes
a base 500 configured to be manipulated by a user's hand;
an end-effector 207 for mounting a surgical tool 202;
an actuation unit (seen in fig.17, including pitch adjustment mechanism 312, yaw adjustment mechanism 412, and z-axis adjustment mechanism including motors 220, 222, 224, and associated transmission means, [0170], etc.) connected between the base 500 and the end-effector 207 for moving the end-effector 207, and therefore the surgical tool 202 with respect to the base 500;
a tracking unit 114/116/108 configured to determine in real time a pose of any of the tool 202, the end-effector 207, and the base 500 with respect to the patient's body; and
a control unit 112/120 for controlling the actuation unit, the control unit 112/120 configured to determine a capability of the tool 202 to reach a planned volume to be treated by movement of the actuation unit of fig. 17 independently of the base 500; and if not all the planned volume can be reached, provide an indication to the user to move the base 500 to a new pose of the base 500. ([0145], [0147]-[0149], [0294]-[0305].
Bozung does not teach a support unit, as claimed.
Hudson teaches a base 14 configured to be manipulated in a user’s hand; an end effector and tool (chuck and drill bit); and a support unit 10/20 (choosing the fig. 7 embodiment of arrangement for horizontal base 16) coupled solely to the base 14. The support unit includes a v-shaped end 16d as at fig. 7 capable of contacting a support surface (no reason this could not be a patient’s body). It is noted that the fig. 7 embodiment is specifically adapted for use on surfaces of various contour (col. 1, line 24), such surfaces known to be found in a patient’s body. Interaction between 16 and a work surface is considered to be a partial mechanical link. As clearly seen in fig. 1, the support unit does not obstruct path of the tool. A longitudinal axis exists through 10/20 along a longest portion of the support unit which is not parallel to a longitudinal axis of the base 14 along a longest portion, thereof. (See marked up figure)
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The term “partial mechanical link” is defined in applicant’s specification to mean “a mechanical link between at least two parts, wherein a relative movement of said at least two parts in at least one degree of freedom is possible”. This is achieved by Hudson where support unit 10/20 is capable of movement in a horizontal direction (as by actuating screw-adjustment sleeve 48) or by permitting pivoting of the drill relative thereto.
It would have been obvious to one with ordinary skill in the art at the time of the invention to add a support unit of Hudson to the Bozung device, such as by having element 10/20 and associated structure be attached to the Bozung device on the bracket structure 700 (near that marking in fig. 2) near the end effector and tool (and including an aperture in Bozung’s bracket with properly interacts with the formations of element 20 of Hudson). Making such a combination would have resulted in the actuation unit moving independently of the support unit. One would have done so in order to securely and accurately guide the Bozung device during use (Hudson, col. 1, lines 19-20). Such modification would have resulted in the end effector of the device extending beyond the support unity (in order for it to continue to be able to accomplish its goal of reaching target tissue). Further, the actuation unit would move the end effector 207 independently of the support unit in such an arrangement. Additionally, such modification would have been an ergonomic improvement for the surgeon in that less weight must be held in place by the surgeon’s strength during the operation.
Regarding claims 32 and 33, in some situations (depending on the size the treatment area), the new pose is capable of permitting treatment of the entire volume, or an iteration of poses is capable of being implemented to treat the entire volume.
Regarding claims 34 and 35, the support unit 10/20 of Hudson is considered to include a damping element 20. Examiner takes the position that all elements are “capable of absorbing” some amount of “reaction forces exerted” thereon. Further, all materials are known to have some amount of elasticity based on the material, size, shape, etc., such elasticity being a damping action. 20 is taught being formed of a “stout structural material” as at col. 2, line 39. Support 10/20 is capable of pressing against a part of the patient’s body adjacent to the part to be treated. Characteristics of the damping element are considered adjustable either by providing bar 20 of different material, thickness, size, shape, etc.; and/or by adjusting length and angular placement of 10 relative to 20 by actuation of element 48 and 30 (e.g. changing length of a bending cantilevered portion of the bar 20).
In an alternative interpretation, sliding arrangement of 20 relative to the housing 14 is permitted, and frictional interaction therebetween is adjustable by a spring-pressed ball detent. (col. 3, lines 17-30) which can be adjusted to vary frictional interengagement. Such can also be considered an adjustable damping means.
Regarding claim 36, the length and angle of the Hudson support are adjustable by actuation of elements 48 and 30. There is no reason that 16 cannot be set on a surface distal from a part of the patient’s body to be treated.
Examiner presumes the term “distal” to be used in this case to mean “some distance away from”, rather than a “distal/proximal relationship”. If applicant argues that the Apkarian arrangement is not “distal”, examiner will issue a rejection under 35 USC 112(b) stating that this is an indefinite relative term.
Regarding claims 40 and 43, Bozung teaches the system including a user interface 1402 configured to indicate feedback information to the user [0154], wherein the feedback information provided by the user interface comprises an indication of whether treatment of the planned volume is achievable without changing the pose of the base 500 with respect to a part of the patient’s body to be treated, including a direction to move the base 500. ([0317], [0323], [0325], [0423], [0426], etc.)
Regarding claim 45, the support of Hudson is taught being slidable relative to the housing (col. 3, line 8). When pressed and slid down by engagement of 10 to the work piece, the tool is capable of extending beyond the support unit.
Allowable Subject Matter
Claim 49 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to David Bates whose telephone number is (571)270-7034. The examiner can normally be reached Monday through Friday, 10AM-6PM
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/DAVID W BATES/Primary Examiner, Art Unit 3799