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 .
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 1-20 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 1 recites “interoperative” in line 3. There is confusion as to what is being meant. In applicant specification, applicant seems to interchangeably describe this. In the spec., specifically in the abstract, claims, summary and until ¶0047, the term “interoperative” is used to describe the imaging (using c-arm, for example). From there onwards, till ¶0189 (end of spec.), the term “intraoperative” is being used to describe the different figures and examples using the c-arm. Hence, it is not certain what is being claimed here, and if there is any difference between intraoperative and interoperative intended by the applicant. For examination purpose, examiner interprets that the terms can be interchangeably used, to represent any imaging during a surgical procedure.
Claim 1 recites “identified as” in line 10. It is clear what this means. There is no identification previously recited. Examiner interprets as some features were initially identified for the preoperative plan.
Claim 1 recites “corresponding plurality” in line 10. It is not understood what this is corresponding to. There is only one identification of anatomical features. There is nothing else to correspond to. Examiner interprets that these anatomical features are the preoperative registration makers.
Claim 1 recites similar limitations with regards to the interoperative registration markers in lines14-17. Claim 1 rejected for same reasons as above.
Claims 2-20 recite or encompass similar limitations and are rejected for same reasons as above.
Note, all rejections that follow are in view of the rejections and interpretations.
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.
Claims 1-5, 7-11, 13-20 rejected under 35 U.S.C. 103 as being unpatentable over Avalos [US 20180280611 A1] in view of Aghdasi [US 11295460 B1]
As per claim 1, Avalos teaches an image-guided robotic spine injection system (Avalos Fig 37), comprising:
a spine injection robot (Avalos Fig 37, ¶0164 “deliver neural progenitor cells expressing glial cell line derived neurotrophic factor into a patient's spinal cord”) comprising an end effector configured to hold an injection device (Avalos ¶0164 “guiding arm of the stereotactic device can be used to advance the hollow needle of the floating cannula”, i.e. guiding arm and floating cannula corresponds to the claimed end effector and injection device),
said spine injection robot being configured to be registered to an interoperative imaging system (Avalos ¶0125 “intraoperative imaging (e.g. MRI and/or CT, and/or ultrasound, and the like)… sensors and/or cameras communicate with a computer”) for real-time guidance of said injection device (Avalos ¶0125 “the coordinates are registered continuously in order to account for any patient motion before or during the injection process.”, ¶0115 “…provide feedback to a central control unit, which is configured for controlling one or more component of the device, so that the relative position of each arm can be determined and properly adjusted during a procedure.’); and
a guidance system (Avalos ¶0117 “a computing device”) configured to communicate with said spine injection robot and said interoperative imaging system during an injection procedure (Avalos ¶0114 “Stereotactic Device Automation”, ¶0117 “Cannula Device Automation”, ¶0120 “Syringe Pump Device Automation” ¶0124, communication with the control device is implied from these sections),
wherein said guidance system comprises a preoperative injection plan for a planned injection procedure on a subject (Avalos ¶0125 “a user may input or select coordinates and/or a region of interest on a computing device … from a pre-operative image”), said preoperative injection plan being based on preoperative imaging data of at least a portion of a subject's spine (Avalos ¶0125 “…the coordinates may be based on landmarks determined from a pre-operative image”, ¶0124 “various imaging techniques, … determine localization of the cannula within the spinal cord”), said preoperative injection plan comprising a plurality of anatomical features identified as a corresponding plurality of preoperative registration markers (Avalos ¶0125 “the coordinates may be based on landmarks determined”),
wherein said guidance system is configured to receive interoperative imaging data from said interoperative imaging system of at least said portion of said subject's spine (Avalos ¶0125 “information received from the one or more camera (as described above) and/or additional intraoperative imaging”), wherein said guidance system is further configured to receive as input from a user an indication of a plurality of anatomical features (Avalos ¶0125 “a user may input or select coordinates and/or a region of interest … the coordinates may be based on landmarks”, ¶0126 “prompt a user to select a range of possible coordinates for injection, or give an option to input exact coordinates. In some embodiments, the user may manually input the coordinates.”)
wherein said guidance system is further configured to register said plurality of interoperative registration markers with said plurality of preoperative registration markers (Avalos ¶0125 “register and optionally re-register relative coordinates of the device and/or vasculature (determined by IR or visible range imaging). In some embodiments, the coordinates are registered continuously…”) to transform said preoperative injection plan to an interoperative injection plan (Avalos ¶0125-¶0126 “account for any patient motion before or during the injection process… automatically adjust the position of one or more arms …the user may select the number of injections need for the procedure and/or the time needed between injections and/or the volume of fluid introduced by each injection… the stereotactic device (and cannula and needle attached thereto) will be automatically positioned to the location of interest based on the confirmed coordinates.” This an interoperative injection plan that was “transformed” or calculated and changed, based on the registering and re-registering described),
and wherein said guidance system is further configured to provide injection guidance instructions to said spine injection robot to perform autonomous injections into the spine of a subject by said injection device (Avalos ¶0114-¶0124, ¶0164, ¶0059).
In view of 112 rejection above, Avalos does not expressly teach identifying as a plurality of interoperative registration markers that correspond in a one-to-one relationship to each respective one of said plurality of preoperative registration markers.
Aghdasi, in a related field of mediated-reality viewer, teaches teach identifying as a plurality of interoperative registration markers that correspond in a one-to-one relationship to each respective one of said plurality of preoperative registration markers (Aghdasi Col 2 lines 54-62 “The processing device can globally and/or locally register the preoperative image data to the intraoperative image data by, for example, registering/matching fiducial markers and/or other feature points … further apply a transform to the preoperative image data based on the registration to, for example, substantially align”).
Before the effective filing date of the claimed invention it would have been obvious to a person of ordinary skill in the art to modify the apparatus in Avalos by integrating registration matching as in Aghdasi, so as to overlay a 3D graphical representation and present the mediated-reality view that enables, simultaneously viewing of surgical site the underlying 3D anatomy (Aghdasi Col 3 lines 1-6).
As per claim 2, Avalos in view of Aghdasi further teaches wherein said plurality of anatomical features are at least a portion of each of a plurality of vertebrae of said subject (Avalos ¶0125 “an anatomical target (e.g. spinal cord injection site)”), and wherein said registering said plurality of interoperative registration markers with said plurality of preoperative registration markers accounts for relative movement of said subject's vertebrae in the interoperative imaging data compared to the preoperative imaging data (Avalos ¶0125 “the coordinates are registered continuously in order to account for any patient motion before or during the injection process”).
As per claim 3, Avalos in view of Aghdasi further teaches wherein said preoperative injection plan includes boundaries (Avalos ¶0147 “provide a space or distance between the distal edge of the base cannula 406 and the distal stopper 410b. This will allow the floating cannula 404 a limited range of movement along the longitudinal axis of the cannulas”) to prevent said injection device from damaging said subject's spinal cord or other nerves (This is intended use of the claimed limitation).
As per claim 4, Avalos in view of Aghdasi further teaches a tracking system configured to communicate with said guidance system (Avalos ¶0118), wherein said tracking system is arranged to be registered to and track said spine injection robot (Avalos ¶0118), said end effector of said spine injection robot (Avalos ¶0118 “track relative motion between cannula parts (e.g. the floating and base cannulas of the cannula system) and/or between one or more cannula parts and the stereotactic device,”), a needle (Avalos ¶0118 “track the depth of injection of the cannula needle”) and injection device when attached to said end effector (Avalos ¶0118), an imaging portion of said interoperative imaging system, and said plurality of vertebrae of said subject while in operation (Avalos ¶0124, ¶0125 “sensors and/or cameras communicate with a computer that is used to register and optionally re-register relative coordinates of the device and/or vasculature”).
As per claim 5, Avalos in view of Aghdasi further teaches said tracking system provides closed-loop control of said spine injection robot based on tracking information from said tracking system (Avalos ¶0115 “…provide feedback to a central control unit”).
As per claim 7, Avalos in view of Aghdasi further teaches further comprising said interoperative imaging system (Avalos ¶0125 “MRI and/or CT, and/or ultrasound, and the like”).
As per claim 8, Avalos in view of Aghdasi further teaches wherein said preoperative imaging data is three-dimensional preoperative imaging data (Aghdasi Col 2lines 56-58 “feature points visible in 3D data sets representing both the preoperative…”), and wherein said interoperative imaging system is configured to provide a plurality of two-dimensional interoperative images from a plurality of different views (Aghdasi Col 5 lines 44-Col 6 line 3 “the camera array 110 includes a plurality of cameras 112 … that are each configured to capture images of a scene 108 from a different perspective … all or a subset of the cameras 112 and the trackers 113 can have different extrinsic parameters, such as position and orientation.”).
As per claims 9-11, 13-20, have limitations similar to claims 1-5, 8 and are rejected for same reasons as above. As per claims 18-20, Avalos in view of Aghdasi further teaches a non-transitory computer-readable medium storing a set of instructions (Avalos ¶0117).
Claims 6, 12 rejected under 35 U.S.C. 103 as being unpatentable over Avalos in view of Aghdasi as applied to claims 1, 9 above, and further in view of Yang [US 20130060146 A1].
As per claim 6, Avalos in view of Aghdasi further teaches a preoperative planning module configured to receive preoperative imaging data of said at least said portion of said subject's spine (Avalos ¶0125 “preoperative imaging (e.g. MRI and/or CT, and/or ultrasound, and the like)… visually select and virtually mark an anatomical target (e.g. spinal cord injection site), implies spine as target area”),
Avalos in view of Aghdasi does not expressly teach wherein said preoperative planning module is further configured to receive a planned injection point and a planned destination point from a user and to display a corresponding calculated needle path to said user.
Yang, in a related field of image-guided target tracking, teaches wherein said preoperative planning module is further configured to receive a planned injection point and a planned destination point from a user and to display a corresponding calculated needle path to said user (Yang Fig. 7, ¶0102 “acquiring preoperative imaging data and developing a surgical plan, … displaying or otherwise communicating this surgical guidance information to a surgeon or operator.”, ¶0109 “the vertebrae 23 preoperative position is used to develop the surgical plan. In developing the surgical plan, the principle axis 26 is determined to ensure avoidance of the spinal cord 24. The preoperative positions of the structures are indicated with solid lines. … provides a dynamically updated surgical plan”).
Before the effective filing date of the claimed invention it would have been obvious to a person of ordinary skill in the art to modify the apparatus in Avalos in view of Aghdasi, by integrating preoperative plan development and displaying as in Yang. The motivation would be to for generating guidance feedback (Yang ¶0102).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OOMMEN JACOB whose telephone number is (571)270-5166. The examiner can normally be reached 8:00-4:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, ANNE M KOZAK can be reached at 571-270-0552. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Oommen Jacob/ Primary Examiner, Art Unit 3797