DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Terminal Disclaimer
The terminal disclaimer filed on June 5, 2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of 11331153 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-3 and 6-10 are rejected under 35 U.S.C. 103 as being unpatentable over US 2008/0154389 to Smith in view of US 2006/0142657 to Quaid and in further view of US 2011/0112549 to Neubach.
Regarding Claim 1, Smith teaches a method for performing a medical procedure using a medical robot system, comprising:
providing a medical robot system including:
a robot including a display (display 29, fig. 1) and an arm (robot arm 23, fig. 1);
an end effector (30, Fig. 1) coupled to the arm;
a dynamic reference base capable of being coupled to a patient (calibration frame 700, Fig. 16; par. 0128-0132);
an optical tracking system configured to track the position of the arm, the end effector and the reference base (light markers are placed on the robot and reference base for optical tracking, par. 0044, 0129); and
a processor coupled to the robot and the optical tracking system, the processor providing image registration data of the patient and the robot system to the display (steps 270 and 280, fig. 11; as shown in fig. 15A-15B);
wherein the optical tracking system includes optical markers positioned on the reference base (par. 0129-0132) and the robot (par. 0129-0132) to track positions of the patient and the end effector (intended use of the dynamic reference base and robot tracking is to register to a common frame of reference in order to position the robot’s end effector relative to the defined trajectories, as in par. 0132), and
wherein the processor is adapted to automatically generate a planned trajectory (par. 0040; planned trajectory 670, fig. 15B), causing the robot arm to position the end effector along the planned trajectory (par. 0055-0056 automatically generates and follows the planned trajectory in response to user inputs to set or reset the trajectory path), and
steering the end effector along the trajectory while utilizing the optical tracking system to track a real-time location of a tip of the end-effector (par. 0044 optical tracking is used; steps 530, 540, 550, tip position is determined and 563 steered towards the target).
However, while Smith teaches optical markers on the robot (par. 0129), Smith does not teach the precise location of the optical markers on the robot, and therefore does not expressly teach wherein the optical markers on positioned on the end-effector.
In the same field of endeavor with respect to image-guided robotic surgery, Quaid teaches a medical robot system, comprising:
a robot including a display (display 23, fig. 1) and an arm (haptic device robot arm 30, fig. 1, 2A);
an end effector coupled to the arm (end effector 35, fig. 2A);
a dynamic reference base capable of being coupled to a patient (anatomy trackers 43a, 43b, fig. 1);
an optical tracking system configured to track the position of the arm, the end effector and the dynamic reference base (tracking system 40, fig. 1, par. 0128-0130 teaches optical tracking; optical detection device 41, fig. 1); and
a control system coupled to the robot and the optical tracking system, the control unit providing image registration data of the patient and the robot system to the display (computers 21, 31, fig. 1; image registration, e.g. a virtual representation of a tracked surgical tool is superimposed on an image of the anatomy, par. 0128-0129),
wherein the optical tracking system includes optical markers positioned on the arm (array of reflective marker spheres 45, fig. 2A; par. 0135-0136), the reference base (trackers 43a, 43b, fig. 1 are arrays of reflective marker spheres, par. 0134) and the end effector (tracker 47, fig. 6B is an array of reflective marker spheres, par. 0137) to track a position of the patient and the end effector,
wherein the control system is adapted to automatically generate a planned trajectory region causing the robot arm to position the end effector within the planned trajectory region (virtual pathways are used to guide the tool held by the end effector, par. 0108, 0184; the end effector is restrained to the trajectory region, par. 0161, guiding line trajectory 722, fig. 47), and
steering the end effector along the trajectory while utilizing the optical tracking system to track a real-time location of a tip of the end-effector (tip of the tool 50 is tracked and steered to the treatment target area during surgery, par. 0185).
One of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to include the optical markers on the robot arm, the reference base and the end effector of Smith in order to provide successful tracking of the moving components of the robot in a frame of reference as suggested by Smith and expressly taught by Quaid.
Smith also does not teach wherein the planned trajectory is non-linear. Instead, Smith teaches a linear trajectory (670, fig. 15B).
Quaid further suggests wherein the planned trajectory is non-linear (cone-shaped, funneling the trajectory to a target object in an “approach mode”, par. 0184; cone-shaped is both non-linear and curved; Quaid further teaches that certain tissues should be avoided, suggesting that guide line trajectories could be designed to be curved/non-linear along any desired path to avoid critical anatomy, par. 0161).
It is noted that for claim interpretation, the term “non-linear” is considered to be any trajectory that is not a straight line. For example, a curved trajectory is considered as being non-linear in this instance. 3D haptic objects also appear to meet this definition of non-linear. Although Quaid teaches that the system may move non-linearly within a 3D haptic object, Quaid does not expressly teach “planning” to move along a non-linear trajectory.
Neubach teaches robotically controlled movement along a non-linear (i.e. curved) path by manipulating an effector base (par. 0004; robot arm 25 is shown in Fig. 2 coupled with needle end effector 24). The end effector is first positioned at an entry point (step 52, fig. 9). Then a trajectory to a target is planned (step 53-54, fig. 9). The trajectory between the entry point and the target is non-linear (i.e. curved) in order to avoid critical anatomy (par. 0108, abstract). The end effector is then manipulated by the robot to move it along the trajectory to the target point (steps 55-65, fig. 9, especially steps 56, 64). It is inherent that going around critical anatomy situated between a point and a target presents a non-linear trajectory.
One of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to utilize the robot manipulation of Neubach to reach the target along a non-linear trajectory in order to advantageously and predictably avoid critical anatomy, as expressly taught by Neubach and suggested by Smith and Quaid.
Regarding Claim 2, Smith further teaches wherein the end effector is a tube having a pitch axis, a roll axis and a tube axis defining an axis of rotation of the tube (par. 0013, Figs. 5-8; Quaid also teaches this features as an end effector 35 has a cylindrical shape that fits onto tube 36, fig. 2B-2C, 6B and necessarily has axes defining pitch, roll, and rotation in order to provide 3D positioning as illustrated as DOF1-5 in fig. 2B; additional degrees of freedom may also be provided in the end effector via tube 36, par. 0114). Quaid also teaches varying the speed of the end effector travel based on known velocity relationship (abstract). For example, traversing near critical areas would tolerate less permissible error and require more iterations of the feedback loop of Neubach’s Fig. 9, which would slow the travel velocity (i.e. speed) down. One of ordinary skill would find it obvious to optimize the system in such a way and only predictable results would be achieved.
Regarding Claims 3, Smith further teaches wherein the end effector comprises a needle (par. 0046; Quaid also teaches that the end effector may hold any desired instrument for a guided surgical procedure and that instruments may be interchanged during the procedure, par. 0118, surgical tool 50, fig. 2C).
Regarding Claim 6, Smith does not teach auditory feedback but does teach visual feedback (fig. 15). Quaid further discloses wherein when the end effector coincides with the trajectory vector an auditory feedback is provided to indicate the desired trajectory has been achieved (beeps are emitted to indicate correct position of the tool, par. 0190; other auditory feedback may also be provided for indicating a condition, par. 0094, 0132). One of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to additional provide auditory feedback to indicate the trajectory match in the system of Smith in order to decrease reliance on the visual screen for the surgeon as taught by Quaid.
Regarding Claim 7, Smith teaches autonomous robot arm movement at the planned trajectory (par. 0078, 0135). Quaid further teaches wherein the control unit autonomously causes the robot arm to be adjusted to position the end effector at the trajectory vector based on detected optical markers (haptic mode is entered automatically when the end effector achieves a predetermined range from a target of interest, par. 0185; for example, when the end effector is outside the predetermined range 720, motion is free, but when the end effector is inside the predetermined range, it is automatically constrained to the trajectory vector 722, fig. 47, par. 0161).
Regarding Claim 8, Smith further teaches wherein the processor comprises a specially-configured computer (programmed computer, par. 0072).
Regarding Claim 9, Smith suggests wherein the end effector position can only be moved along the trajectory vector (automatically moved along the trajectory unless too much resistance is detected, par. 0135). Quaid further teaches wherein the end effector position can only be moved along the trajectory vector (constrained to 722, fig. 47; par. 0161). One of ordinary skill in the art before the effective filing date of the invention would have found it obvious to constrain the end effector to the trajectory vector in the system of Smith in order to avoid critical anatomy as taught by Quaid.
Regarding Claim 10, Smith does not expressly teach wherein the end effector position can be locked at a fixed distance from the patient, although Smith system would have the capability of guiding the end effector to any desired location. Quaid further teaches wherein the end effector position can be locked at a fixed distance from the patient (the robot arm/end effector may be locked in place, par. 0140-0142) in order to improve calibration. Therefore one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to lock the end effector position in place in the system of Smith in order to improve calibration as taught by Quaid.
Claims 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over US 2008/0154389 to Smith in view of US 2006/0142657 to Quaid and US 2011/0112549 to Neubach, as applied to claim 1 above, and in further view of US 2006/0036264 to Selover.
Regarding Claim 4, Smith does not expressly teach wherein the end effector is coupled with a curved guide tube. However, Smith teaches that the end effector may hold any desired instrument for a guided surgical procedure (par. 0046). Quaid also teaches that the end effector may hold any desired instrument for a guided surgical procedure and that instruments may be interchanged during the procedure (par. 0118, surgical tool 50, fig. 2C).
Selover teaches a robot arm optically guided for an image-guided procedure (fig. 5A), wherein a curved guide tube is coupled to the end effector for use during the procedure (par. 0040, curved guide tube 46, fig. 1).
One of ordinary skill in the art before the effective filing date of the invention would have found it obvious to provide a curved guide tube instrument in the system of Smith in order to provide a guided tube during an image-guided procedure as taught by Selover to be a suitable instrument used during an image-guided procedure and produce only predictable results.
Regarding Claim 5, Smith does not expressly teach wherein a laser light indicates the end effector position by projecting a beam down the trajectory vector and wherein the laser light is positioned at a top portion of the end effector. However, Smith suggests precision laser scan to determine distance (par. 0129).
Selover teaches a robot arm optically guided for an image-guided procedure (fig. 5A), wherein a laser light is projected to mark a planned trajectory (insertion trajectory on tissue is highlighted with a laser beam, par. 0044-0045, 0053-0055).
One of ordinary skill in the art before the effective filing date of the invention would have found it obvious to provide the laser light of Selover in the system of Smith in order to provide the predictable result of highlighting an insertion trajectory on the tissue. Further, one of ordinary skill in the art would recognize that the location of the laser light is a matter of design choice, so long as it is registered with the system and provides optical access along the desired trajectory, as exampled in Selover. As such, one of ordinary skill in the art before the effective filing date of the invention would have found it obvious to place the laser light positioned on the end effector and only expected results would occur, since the end effector is a registered system component that would provide optical access along the desired trajectory.
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.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of copending Application No. 17727013 (reference application, published as US20220241037). Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims are narrower in scope than the instant claims and therefore necessarily teach the claimed invention. They correspond in a one-to-one mapping (e.g. instant claim 1 corresponds to conflicting claim 1, etc). Patent claim 1 teaches instant claim 1 limitation “steering the end effector along the non-linear planned trajectory while utilizing the optical tracking system to track a real-time location of a tip of the end-effector” implicitly because it is using optical tracking and causes the robot arm to position the end effector tip along the planned trajectory, which is non-linear.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant's arguments filed December 23, 2025 have been fully considered but they are not persuasive. Applicant argues Neubach does not teach or suggest “steering the end effector along the non-linear planned trajectory while utilizing the optical tracking system to track a real-time location of a tip of the end-effector” because Neubach teaches ultrasonic tracking instead of optical tracking. This is not found persuasive because the base system of Smith relies on optical tracking. Quaid also relies upon optical tracking. Neubach is relied upon for teaching non-linear trajectories, not its type of tracking system. It appears all the tracking systems would be functionally equivalent and the type is not critical, so long as the objects are tracked. As such, in combination, Smith, Quaid and Neubach arrive at the claim limitation as outlined in the rejection above. Nonobviousness cannot be shown 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).
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 ANGELA MARIE HOFFA whose telephone number is (571)270-7408. The examiner can normally be reached Monday - Friday 9:30 am - 6:00 pm.
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ANGELA M. HOFFA
Primary Examiner
Art Unit 3799
/Angela M Hoffa/Primary Examiner, Art Unit 3799