DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendment
This action is in response to the remarks filed on 11/13/2025. The amendments filed on 11/13/2025 have been entered. Accordingly, claims 1-7 and 9-16 remain pending. Claims 1-6 and 11-16 were withdrawn from further consideration pursuant to 37 CFR 1.142(b). Claim 8 is cancelled.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the actuator as claimed in claim 7 must be shown or the feature(s) canceled from the claim(s). It is noted that the present disclosure states “The output of the filtering stage 810 is then sent to the piezoelectric actuators 802 via the multi-element shielded cable coming from the faraday cage 602 patch panel 604” in reference to fig. 8. However, fig. 8 show 802 being “command input” and reference numeral 812 being “piezo actuator”. If those piezo actuators 812 are in fact the actuators, how they are coupled to the manipulator must be shown.
No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 7 is objected to because of the following informalities:
Claim 7 recites the limitation of “comprising a magnetic resosnance imaging (MRI) system” which the word “resosnance” believed to be misspelled.
Claim 7 recites the limitation of “an imaging device comprising a magnetic resonance imaging (MRI) system, enabling visualization of a tissue” which in an interpretation may be construed as not a positive limitation and therefore not be given weight to it. It is suggested to recite more positive limitations (e.g., magnetic resonance imaging (MRI) system, configured for visualization of a tissue).
Appropriate correction is required.
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.
Claims 7, 9-10 and 17 are 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.
Regarding claim 7, the phrase " at least one other manipulator that may be attached to the controller instead of the first actuated manipulator; " renders the claim indefinite because it is unclear whether the limitations following the phrase “may be” are part of the claimed invention. See MPEP § 2173.05(d).
Claim 18 verbatim recites “18. (New) The manipulator comprises two separable components in the form of said actuator and an application specific or patient specific mechanism.” Which is not clear if claim 18 is a dependent claim or independent claim. It is also not clear which claim it depends from if it is a dependent claim.
Further, it is also unclear what are those “two separable components” as the claim merely appear to recite ONE of those as being “in the form of said actuator and an application specific or patient specific mechanism.” For this limitation, the most pertinent section found in the originally filed specification, on the contrary, states “In one embodiment, the manipulator 106 is composed of two separable components, a motor module [hence, not in the form of said actuator] and an application-specific or patient-specific mechanism.”
As the claim best understood in light of the specification, it will be presumed that claim 18 is a dependent claim which depends from claim 7; and the components are “a motor module and an application-specific or patient-specific mechanism.”
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 negatived by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 7 and 9 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Appenrodt et al (US 20090264899, published on 2009-10-22 and filed on 2008-04-17), (hereinafter “Appenrodt”) in view of Ozcan et al (Fast and Efficient Radiological Interventions via a Graphical User Interface Commanded Magnetic Resonance Compatible Robotic Device, Proceedings of the 28th IEEE EMBS Annual International Conference New York City, USA, Aug 30-Sept 3, 2006), (hereinafter “Ozcan”).
Regarding claim 7, Appenrodt teaches a modular system for image guided robotic assisted medical procedure (see fig. 1-16; “As illustrated in FIGS. 1-15, the drive system 12 can be used to guide one or more exemplary instruments 14, such as one or more electrodes, into the brain 98.” [0095]; “tracking system 54 can continuously recompute the relative position of the DRF 64 and the instrument 14 during localization and relate this spatial information to patient registration data to enable image guidance of the instrument 40 within and/or relative to the patient 16.” [0049]), the system comprising:
a manipulator for performing a deep brain stimulation procedure (“instruments 14 can be advanced by the drive system 12 into the anatomy, including those examples discussed herein, such as … DBS probes, macroelectrode stimulators, or other appropriate instruments” [0054]);
a plurality of computer-controlled actuators coupled to said manipulator (“The drive system 12 [of instruments 14] can include a driven or control portion 100, a connector rod or support portion 102, a drive portion 104 and a guide system 106” [0054]);
a controller connected to said actuators for providing siqnals to said actuators in order to move said manipulator in at least one deqree of freedom for creatinq computer-controlled motion thereof, said controller and said actuators also capable of coupling to and directing at least one other manipulator that may be attached to the controller instead of the first actuated manipulator (“drive system 12 to control the insertion and withdrawal of one or more instruments 14 from the anatomy” [0028]; “The drive system 12 can be interconnected with various guide or support portions, such as …robotic devices, or guide devices, to drive various instruments into selected portions of the anatomy. For example, the stereotactic head frame 68 a can comprise any suitable stereotactic head frame … The drive system 12 can be interconnected with the head frames 68 to position the drive system 12 at any appropriate location to drive various instruments 14 into a cranium 108. Any appropriate instruments 14 can be advanced by the drive system 12 into the anatomy, including those examples discussed herein, such as electrodes” [0054], also see [0055]-[0063]);
an imaging device comprising a magnetic resonance imaging (MRI) system, enabling visualization of a tissue at said deep brain stimulation procedure (“navigation system 10 that can include the imaging device 18… any appropriate imaging system, navigation system, patient specific data, and non-patient specific data can be used…intraoperative imaging system can include an MRI imaging system” [0031]; “an imaging device controller 30, to identify whether or not the imaging device 18 is actively imaging” [0033]; also see [0034]-[0039]); and
a computer communicatively coupled to said imaging device and said controller, wherein the computer collects and processes images from said imaging device and instructs said controller to direct said manipulator (“the x-ray source 20 generates the x-rays that propagate to the x-ray receiving section 22, the radiation sensors 26 can sense the presence of radiation, which is forwarded to an imaging device controller 30, to identify whether or not the imaging device 18 is actively imaging” [0040]; also see [0041]-[0053]);
wherein the computer collects and processes images from said imaging device and said controller to direct said manipulator via said signals to said at least one actuator module to move said manipulator by said computer from said imaging device in order to perform the deep brain stimulation procedure (“imaging device 18 … include an MRI imaging system…the navigation system 10 can incorporate or be used with any appropriate preoperatively or intraoperatively acquired image data. For example, images from atlas models can be used to produce patient images” [0031]; “imaging device 18 … other alternative 2D, 3D or 4D imaging modality may also be used. For example, any 2D, 3D or 4D imaging device, such as … magnetic resonance imaging (MRI), … MRI may also be used to acquire 2D, 3D or 4D pre- or post-operative and/or real-time images or patient image data 36 of the patient 16” [0035]).
Appenrodt does not seem to point out the specifics of coupling to and directing at least one other manipulator that may be attached to the controller instead of the first actuated manipulator; and wherein the computer instructs said controller to direct said manipulator under computer control via said signals to said actuators to move said manipulator based upon said images collected by said computer from said imaging device.
However, in the same field of endeavor, Green teaches FIG. 4 illustrates a perspective view of a workstation 400 that can be used to control manipulator 100 (or two such manipulators) and surgical tool 150 (or two such surgical tools, one held by each of two such manipulators). In certain embodiments, workstation 400 comprises input devices 20 shown in FIGS. 1A and 1B to control movement of manipulator 100 [0047].
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the method and device of the modified combination of references as outlined above with controller capable of directing at least one other manipulator as taught by Green because it would help user to execute a command instructing the medical robot to perform the movement without the need for the user to manipulate an input device to cause real-time responsive movement of the medical robot (abst of Green).
Further, also in the same field of endeavor, Ozcan teaches graphical user interface for an MR compatible robotic device has the capability of displaying oblique MR slices in 2D and a 3D virtual environment along with the representation of the robotic arm in order to swiftly complete the intervention (abst). The patient is placed in the scanner along with the robot and the slices of interest are imaged using the scanner. The raw data are transferred to the operator's computer (Fig. 5) including the coordinates of the slices and the fast Fourier transform is computed to obtain the images. The images are presented with the graphical user interface (GUI) in two different fashions (see Fig. 3). First, two dimensional images are shown in the windows placed on top of the GUI to decide about the entry and target point of the intervention. These windows are called slice windows. Second, there is an additional window, called 3D window, that provides a virtual presentation of the robot, of the slices displayed in their physical positions and of the gantry. As shown in Fig. 3 each of the slice windows is associated with a marker. The first window displays the entry point marker and the second displays the target point marker. Using the mouse, the operator can move any of these points in order to decide about the best insertion path for the intervention. The markers are also shown in the 3D environment on their respective locations on the slices. As soon as any of the points is moved in the slice windows, the markers in 3D follow the motion of their 2D counterparts. The virtual robot in the 3D window positions itself inline with the insertion path defined by the entry and the target point. This is accomplished by solving the inverse kinematics of the robot [10]. This mode of operation is called automatic placement.
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the method and device of the modified combination of references as outlined above with wherein the computer instructs said controller to direct said manipulator via said signals to said at least one actuator module to move said manipulator based upon said images collected by said computer from said imaging device as taught by Ozcan because it provided advantages of saving time and effort and it is safer for the medical staff and is more comfortable for the patient (See abst of Ozcan).
Regarding claim 9, Appenrodt teaches the manipulator is designed to operate in the MRI environment (“MRI may also be used to acquire 2D, 3D or 4D pre- or post-operative and/or real-time images or patient image data 36 of the patient 16. For example, an intra-operative MRI system, may be used such as the PoleStar® MRI system” [0035]).
Claims 10 and 17 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Appenrodt in view of Green and Ozcan as applied to claim 7 above and further in view of Mozer et al (Robotic Image-Guided Needle Interventions of the Prostate, [Rev Urol. 2009;11(1):7-15]).
Regarding the claim 10, the combination noted above teaches all the limitations of claims as noted above including real-time MRI images being acquired intraoperatively see Appenrodt [0035] which indicates the minimal degradation of MRI image. Similarly, Green also indicates the minimal degradation of MRI image see [0059].
Despite the teachings noted above, the combination does not specifically note MRI compatible manipulator or as appeared to be intended to claim limitation of “manipulator is designed to operate with a minimal degradation of MRI image quality”.
However, in the same field of endeavor, Mozer teaches Image-guided robots have stringent requirements for MRI imager compatibility. A robot’s compatibility with a medical imager refers to the capability of the robot to safely operate within the confined space of the imager while performing its clinical function, without interfering with the functionality of the imager (pg. 9 most right col. last par.). The MrBot robot was constructed to be multi-imager compatible, which includes compatibility with all classes of medical imaging equipment and it is the only fully MRI compatible motor (pg. 13 middle and right col.).
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the method and device of the modified combination of references as outlined above with manipulator is designed to operate with a minimal degradation of MRI image quality as taught by Mozer because it helps to establish a digital platform for integrating medical imaging data (conclusion of Mozer).
Regarding claim 17, the combination noted above teaches all the limitations of claims as noted above except for piezoelectric motors.
However, in the same field of endeavor, Mozer teaches A robotic intervention assistant was constructed for open MRI to provide a guide for needles and probes. To minimize image interference from the piezoelectric motors, the robot had to be located distally, at the top of the imager between the vertical coils of the MRI. To operate at the isocenter, long arms had to be extended, which made them flexible (Prostate DIGI Robots section).
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the method and/or device of the modified combination of reference(s) as outlined above with piezoelectric motors as taught by because it helps to minimize image interference (Prostate DIGI Robots section of Mozer).
Claim 18 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Appenrodt in view of Green and Ozcan as applied to claim 7 above and further in view of Sutherland et al (US 20080161830 A1).
Regarding claim 18, the combination noted above teaches all the limitations of claims as noted above except for manipulator comprises two separable components in the form of said actuator and an application specific or patient specific mechanism.
However, in the same field of endeavor, Sutherland teaches piezoelectric motors are used for the robot drive mechanisms. They have the advantage of being non-magnetic, self-braking, MR-compatible, and able to meet the operating time specifications [0058]. The robot's work envelope is tailored to a specific procedure, and suitably restricted [0074].
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the method and/or device of the modified combination of reference(s) as outlined above with manipulator comprises two separable components in the form of said actuator and an application specific or patient specific mechanism as taught by Sutherland because it helps to overcome the limited capabilities of devices which cause them to fall into disuse (of Sutherland).
Response to Arguments
Applicant’s arguments have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 extension fee 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.
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/SERKAN AKAR/ Primary Examiner, Art Unit 3793