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, 11, 12, 18, and 20, and Claims 2-10, 13-17, and 19 by dependency, 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 Independent Claim 1, Claim 1 recites “the associated respective at least one of the plurality of spatial regions.” There is insufficient antecedent basis for this limitation in the claim (i.e., there is insufficient antecedent basis for modifying the recited “respective at least one of the plurality of spatial regions” with the term “the associated”). It is unclear what the term “the associated” is in reference to: the feedback parameters, the spatial regions, or something else.
Regarding Claims 11, 12, 18 and 20, Claims 11, 12, 18 and 20 also recite “the associated respective at least one of the plurality of spatial regions,” and are indefinite for the same reasons as explained above with respect to Claim 1.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 2, 8-13, 15, and 18-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2019/0000556 A1 to Sela et al. (“Sela”).
Regarding Independent Claim 1, Sela discloses:
A method for supporting users in an operating room by triggering feedback regarding one or more medical instruments, the method being performed by at least one processor and comprising: (Title, “Medical electronic device with multi-tracking cameras;” Para. [0010], “FIG. 2 is a perspective view of a medical procedure room in which a medical electronic device in accordance with example embodiments of the present disclosure is used;” Para. [0053], “Exemplary aspects of the disclosure can be implemented via processor(s) (such as the processor 311 of the medical tracking system 302 and/or a processor of the control and processing unit 304)) coupled with memory;” Abstract, “The processor is configured to determine, based on data received from the first tracking system and data received from the second tracking system, transposition information to map data received from the first tracking system and data received from the second tracking system into a common space.”);
Sela’s “determin[ing] … transposition information…” is such “triggering feedback” as claimed.
obtaining spatial information indicative of a plurality of spatial regions in the operating room, (Para. [0034], “The medical tracking system of FIG. 2 includes a first tracking system 206 which acts as a primary tracking system. The first tracking system 206 is providing a first tracking region 207. The first tracking region 207 is a region in front of the first tracking system 206 that the first tracking system 206 is able to observe. That is, the first tracking region 207 is an area that is represented in data generated by the first tracking system 206. The first tracking system 206 is configured to track the tracked instrument within the first tracking region;” Para. [0041], “The second tracking system 208 is providing a second tracking region 209. … The second tracking system 208 is configured to track the tracked instrument within the second tracking region.”);
each of the plurality of spatial regions being associated with one or more feedback parameters; (Para. [0045], “The tracking systems may track the tracking markers and, more particularly, the tracked instrument, based on light reflected. That is, the tracked instrument may be tracked based on the light reflected from the tracking markers on the tracked instrument.”);
Sela’s “the light reflected from the tracking markers on the tracked instrument” is such a feedback parameter as claimed.
obtaining tracking information indicative of tracked poses of a plurality of medical instruments in the operating room; (Para. [0050], “The processor 311 may be configured to track the tracked instrument using data from the first tracking system 206 and data from the second tracking system 208;” Para. [0032], “…for example, the optical tracking system knows the position in space of a tip of a medical instrument relative to the tracking markers being tracked;” Para. [0031]);
associating, based on the spatial information and the tracking information, each of the plurality of medical instruments to a respective at least one of the plurality of spatial regions; (Para. [0005], “ The processor is configured to receive, data from the first tracking system. The first tracking system is providing a first tracking region and the first tracking system is configured to track a tracked instrument within the first tracking region. The processor is further configured to receive data from the second tracking system. The second tracking system is providing a second tracking region. The second tracking system is configured to track the tracked instrument within the second tracking region. The processor is further configured to determine, based on data received from the first tracking system and data received from the second tracking system, transposition information to map data received from the first tracking system and data received from the second tracking system into a common space.”);
and triggering feedback, for each of the medical instruments, according to the one or more feedback parameters of the associated respective at least one of the plurality of spatial regions. (Para. [0033], “A medical navigation system 205 comprising an equipment tower, tracking system (which is an optical tracking system in the embodiment of FIG. 2), displays and tracked instruments 211 assist the surgeon 201 during his procedure.”).
Regarding Claim 2, Sela discloses the entirety of Claim 1 as explained above.
Sela additionally discloses:
wherein the one or more feedback parameters are region-specific and/or differ between two or more of the plurality of spatial regions. (Para. [0034], “…the first tracking region 207 is an area that is represented in data generated by the first tracking system 206. The first tracking system 206 is configured to track the tracked instrument within the first tracking region;” Para. [0041], “The second tracking system 208 is configured to track the tracked instrument within the second tracking region.”).
Sela’s “feedback parameters are region-specific” in that each tracking region tracks only markers in that region, which markers (as explained above) reflect light whose detection is such a feedback parameter as claimed.
Regarding Claim 8, Sela discloses the entirety of Claim 1 as explained above.
Sela additionally discloses:
wherein the spatial information is determined or defined based on patient image data comprising one or more medical images of at least a portion of a patient’s body (Para. [0037], “By observing the tracked instrument 211 during the patient registration procedure, the medical electronic device may determine the location of the patient 202 in space. This allows the medical electronic device to map the physical coordinate space of the operating room to the image space of the magnetic resonance imaging (MRI) image, computerized tomography (CT) image, or image of another type.”).
Regarding Claim 9, Sela discloses the entirety of Claim 8 as explained above.
Sela additionally discloses:
further comprising: obtaining information indicative of the spatial regions in a coordinate system of the patient image data; obtaining a transformation between the coordinate system of the patient image data and a real-world coordinate system; (Para. [0037], “…fiducial points may be identified on images and then the tracked instrument may be used to touch the associated locations. By observing the tracked instrument 211 during the patient registration procedure, the medical electronic device may determine the location of the patient 202 in space. This allows the medical electronic device to map the physical coordinate space of the operating room to the image space of the magnetic resonance imaging (MRI) image, computerized tomography (CT) image, or image of another type.”);
and determining the spatial information by transforming the information indicative of the spatial regions from the coordinate system of the patient image data into the real-world coordinate system based on the obtained transformation. (Para [0059], “In such embodiments, a coordinate system may be defined with reference to the first tracking system and data associated with the second camera may be mapped to that coordinate system;” Para. [0061], “For example, the transposition information may represent a transposition that may be applied to the position of a tracking marker in a second space (such as a coordinate system associated with the second tracking system) to transpose it to a first space (such as a coordinate system associated with the first tracking system);” Para. [0052]).
Regarding Claim 10, Sela discloses the entirety of Claim 1 as explained above.
Sela additionally discloses:
wherein at least one of the spatial information and the tracking information is obtained for multiple points in time and the feedback is iteratively triggered for two or more of the multiple points in time. (Para. [0002], “ The tracking system may track tracking markers that are provided on a medical instrument, for example. By tracking the tracking markers, the medical electronic device can determine the location, in space, of the tracked tool or instrument. This location information may be used, for example, to facilitate a medical procedure. For example, in some embodiments, the location of the tracked tool or instrument may be used to automatically reposition a robotic arm associated with the medical electronic device;” Para. [0062], “The data from the first tracking system and the data from the second tracking system that are used to determine the position of the tracked instrument are received at substantially the same time to reduce errors from movements of the tracked instrument. In at least some embodiments, the data from the first tracking system and the data from the second tracking system may include respective time stamps or other timing information which indicates the time that such data was acquired;” Para. [0068]; Para. [0033]).
Regarding Claim 11, Sela discloses the entirety of Claim 10 as explained above.
Sela additionally discloses:
wherein one or more of the associated respective at least one of the plurality of spatial regions are updated based on a movement of one or more of the plurality of medical instruments as indicated by the tracking information obtained for multiple points in time. (Paras. [0071] through [0073]; Fig. 4, “Detect Repositioning 408” and “Re-Calibrate 410”).
Regarding Claim 12, Sela discloses the entirety of Claim 11 as explained above.
Sela additionally discloses:
wherein: the associated respective at least one of the plurality of spatial regions is updated such that the medical instrument associated with said respective at least one of the plurality of spatial regions remains within said at least one of the plurality of spatial regions; and/or the associated respective at least one of the plurality of spatial regions is updated such that a medical instrument not associated with said respective at least one of the plurality of spatial regions remains outside said at least one of the plurality of spatial regions. (Para. [0063], “…a plurality of reference tracking markers may be fixedly positioned in a medical procedure room within the first tracking region associated with the first tracking system and the second tracking region associated with the second tracking system;” Para. [0068], “…when the tracked instrument is visible to both tracking systems, data from both tracking systems may be used to determine the position of the tracked instrument. In some embodiments, when the tracked instrument is visible to both tracking systems, the processor determines a position of a tracked instrument within the first tracking region using data from the first tracking system and determines the position of the tracked instrument within the first tracking region using data from the second tracking system.”).
Regarding Claim 13, Sela discloses the entirety of Claim 1 as explained above.
Sela additionally discloses:
wherein the plurality of medical instruments comprises instruments handled simultaneously (Para. [0048], “The medical tracking system 302 may be employed to track one or more of medical instruments 310 (such as the tracked instruments described above) and spatially register the one or more tracked instruments to an intraoperative reference frame.”).
Regarding Claim 15, Sela discloses the entirety of Claim 1 as explained above.
Sela additionally discloses:
wherein the one or more feedback parameters define at least one of an auditory feedback, a haptic feedback and a visual feedback (Para. [0033], “A medical navigation system 205 comprising an equipment tower, tracking system (which is an optical tracking system in the embodiment of FIG. 2), displays and tracked instruments 211 assist the surgeon 201 during his procedure.”).
Regarding Independent Claim 18, Sela discloses:
A system comprising at least one processor configured to: (Para. [0053]; Abstract);
obtain spatial information indicative of a plurality of spatial regions in an operating room, each of the plurality of spatial regions being associated with one or more feedback parameters; (Para. [0034]; Para. [0041]; Para. [0045]);
obtain tracking information indicative of tracked poses of a plurality of medical instruments in the operating room; (Para. [0050]; Para. [0032]; Para. [0031]);
associate, based on the spatial information and the tracking information, each of the plurality of medical instruments to a respective at least one of the plurality of spatial regions; (Para. [0005]);
and trigger feedback, for each of the plurality of medical instruments, according to the one or more feedback parameters of the associated respective at least one of the plurality of spatial regions. (Para. [0033]).
Regarding Claim 19, Sela discloses the entirety of Claim 18 as explained above.
Sela additionally discloses:
further comprising at least one of the following components: a tracking system configured to track the poses of the plurality of medical instruments in the operating room; (Fig. 2, “first tracking system 206” and “second tracking system 208”);
a feedback unit configured to provide the feedback to at least one user in the operating room; (Para. [0047], “The control and processing unit 304 may be interfaced with other external devices, such as the medical tracking system 302 and other devices 306. The other devices 306 may include, for example, data storage, and external user input and output devices, which may include, for example, one or more of a display…;” see also Para. [0033], with reference to “medical navigation system 205” of Fig. 2, noting it to contain the display elaborated upon at Para. [0047])
and a robot configured to handle a medical tool (Para. [0002], “…in some embodiments, the location of the tracked tool or instrument may be used to automatically reposition a robotic arm associated with the medical electronic device.”).
Regarding Independent Claim 20, Sela discloses:
A computer program product comprising non-transitory computer storage medium storing instructions which, when executed on at least one processor, cause the at least one processor to: (Para. [0053]; Abstract);
obtain spatial information indicative of a plurality of spatial regions in the operating room, each of the plurality of spatial regions being associated with one or more feedback parameters; (Para. [0034]; Para. [0041]; Para. [0045]);
obtain tracking information indicative of tracked poses of a plurality of medical instruments in an operating room; (Para. [0050]; Para. [0032]; Para. [0031]);
associate, based on the spatial information and the tracking information, each of the plurality of medical instruments to a respective at least one of the plurality of spatial regions; (Para. [0005]);
and trigger feedback, for each of the plurality of medical instruments, according to the one or more feedback parameters of the associated respective at least one of the plurality of spatial regions. (Para. [0033]).
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 3-5, 14 and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over US 2019/0000556 A1 to Sela et al. (“Sela”) as applied to Claims 1 and 15 above, and further in view of WO 2021003401 A1 to Malackowski et al. (“Malackowski”).
Regarding Claim 3, Sela discloses the entirety of Claim 1 as explained above.
Sela does not disclose:
wherein the plurality of spatial regions are defined based on a pose of at least one reference object in the operating room
Malackowski describes “[s]ystems and methods … wherein a localizer is configured to detect a position of a first object and a vision device is configured to generate a depth map of surfaces near the first object.” Malackowski is analogous art.
Malackowski teaches:
wherein the plurality of spatial regions are defined based on a pose of at least one reference object in the operating room (Para. [0100], “ During an initial phase of a surgical procedure, the trackers 34, 36 may be firmly affixed to the femur F and tibia T of the patient respectively. The position of coordinate systems FBONE and TBONE may then be mapped to the coordinate systems BTRK1 and BTRK2, respectively. For instance, a pointer instrument P (FIG. 1) … having its own tracker PT, may be used to register the femur coordinate system FBONE and tibia coordinate system TBONE to the bone tracker coordinate systems BTRK1 and BTRK2, respectively. The fixed positional relationship between the femur coordinate system FBONE and the bone tracker coordinate system BTRK1, and the fixed positional relationship between the tibia coordinate system TBONE and the bone tracker coordinate system BTRK2, may be stored on the navigation controller 22 as transformation data 83.”).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Sela with the teachings of Malackowski (i.e., to define Sela’s spatial regions based on a pose of at least one reference object in the operating room in the manner of Malackowski) in order to facilitate maneuvering of a surgical instrument in proximity to sensitive anatomical structures while avoiding other objects adjacent the target volume, such as other medical tools and adjacent anatomical structures (Malackowski at Paras. [0003] and [0042]).
Regarding Claim 4, the combination of Sela and Malackowski renders obvious the entirety of Claim 3 as explained above.
Malackowski additionally teaches:
wherein the at least one reference object comprises at least a portion of a patient?s body and/or at least a portion of a medical tool and/or at least a portion of a medical instrument. (Para. [0100], “ During an initial phase of a surgical procedure, the trackers 34, 36 may be firmly affixed to the femur F and tibia T of the patient respectively. The position of coordinate systems FBONE and TBONE may then be mapped to the coordinate systems BTRK1 and BTRK2, respectively.”).
Regarding Claim 5, the combination of Sela and Malackowski renders obvious the entirety of Claim 4 as explained above.
Malackowski additionally teaches:
wherein different ones of the plurality of spatial regions comprise different portions of the patient’s body. (Para. [0100], “ During an initial phase of a surgical procedure, the trackers 34, 36 may be firmly affixed to the femur F and tibia T of the patient respectively. The position of coordinate systems FBONE and TBONE may then be mapped to the coordinate systems BTRK1 and BTRK2, respectively. For instance, a pointer instrument P (FIG. 1) … having its own tracker PT, may be used to register the femur coordinate system FBONE and tibia coordinate system TBONE to the bone tracker coordinate systems BTRK1 and BTRK2, respectively.”).
Regarding Claim 14, Sela discloses the entirety of Claim 1 as explained above.
Sela does not disclose:
wherein different subsets of the plurality of spatial regions are associated with different surgeons
Malackowski is analogous art, as explained above.
Malackowski teaches:
wherein different subsets of the plurality of spatial regions are associated with different surgeons (Para. [0042], “ During a surgical procedure, the surgical navigation system 12 may track the position (location and orientation) of objects of interest within a surgical workspace using a combination of tracker-based localization and machine vision. … The tracked objects may include, but are not limited to … anatomical structures of surgical personal such as a surgeon’s hand or fingers.”).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Sela with the teachings of Malackowski (i.e., to associate different spatial regions with different surgeons in the manner of Malackowski) in order to “provide an accurate and efficient mechanism for the surgical navigation system … to determine the position of such objects in the surgical workspace” (Malackowski at Para. [0043]).
Regarding Claim 16, Sela discloses the entirety of Claim 15 as explained above.
Sela does not disclose:
wherein the visual feedback includes display of a navigation view visualizing the pose of the respective medical instrument
Malackowski is analogous art, as explained above.
Malackowski teaches:
wherein the visual feedback includes display of a navigation view visualizing the pose of the respective medical instrument (Para. [0143], “During a surgical procedure, the navigation controller 22, such as via the surgical navigator 81, may be configured to display the illustration of FIG. 14 along with an image or virtual model for the surgical instrument 16 at the current position of the surgical instrument 16 in the common coordinate system, such as tracked with the localizer 18, to aid a surgeon in guiding the surgical instrument 16 to the target volume 202.”).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Sela with the teachings of Malackowski (i.e., to include display of a navigation view visualizing the pose of the respective medical instrument in the manner of Malackowski) in order to “aid a surgeon in guiding the surgical instrument … to the target volume….” (Malackowski at Para. [0143]).
Regarding Claim 17, Sela discloses the entirety of Claim 16 as explained above.
Malackowski additionally teaches:
wherein the one or more feedback parameters define at least one setting of the navigation view, the at least one setting comprising: a type of medical image data used for rendering the navigation view; a criterion for highlighting structures in the navigation view; a criterion for indicating planned objects in the navigation view; an orientation of the navigation view; and/or a perspective of the navigation view. (Para. [0133], “The model data 82 may also define predetermined profiles for various objects potentially present in the target site, each profile setting forth one or more features specific to the object that aid the navigation controller 22 in identifying the object from the actual depth map. For example, a profile for a given object may include, without limitation, one or more of a color palate, wavelength range, signal intensity range, distance or depth range, area, volume, shape, polarization, and deep metrics output from a learned or statistical model corresponding to the object;” Para. [0135], “… a user may interact with the user interface 24 to manually select an object of the identified portion segmented by the navigation controller 22, and/or to select a predefined profile for the selected object.”).
Claims 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over US 2019/0000556 A1 to Sela et al. (“Sela”) in view of WO 2021003401 A1 to Malackowski et al. (“Malackowski”) as applied to Claim 5 above, and further in view of US 2017/0312035 A1 to May et al. (“May”).
Regarding Claim 6, the combination of Sela and Malackowski renders obvious the entirety of Claim 5 as explained above.
The combination of Sela and Malackowski does not disclose:
wherein at least some of the plurality of spatial regions are separated from one another by one or more virtual planes that are optionally defined relative to the patient?s body.
May describes a “SURGICAL SYSTEM HAVING ASSISTED NAVIGATION” (Title). May is analogous art.
May teaches:
wherein at least some of the plurality of spatial regions are separated from one another by one or more virtual planes that are optionally defined relative to the patient’s body (Para. [0029], “FIG. 2 is a block diagram of an exemplary surgical navigation system embodiment in accordance with the present teachings, such as an Acumen™ Surgical Navigation System…. The Acumen™ Surgical Navigation System can operate in a variety of imaging modes such as a fluoroscopy mode creating a two-dimensional x-ray image, a computer-tomography (CT) mode creating a three-dimensional image, and an imageless mode creating a virtual image or planes and axes by defining anatomical points of the patient's anatomy.”).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of combined Sela and Malackowski with the teachings of May (i.e., to separate the spatial regions of combined Sela and Malackowski with such a virtual plane as taught by May) in order to simplify the required setup by reducing the number of devices required to construct spatial regions (May at Para. [0029]).
Regarding Claim 7, the combination of Sela, Malackowski and May renders obvious the entirety of Claim 6 as explained above.
May additionally teaches:
wherein the one or more virtual planes comprise at least one anatomical plane, at least one user-defined plane and/or at least one plane associated with an anatomical element of the patient’s body. (Para. [0029], “FIG. 2 is a block diagram of an exemplary surgical navigation system embodiment in accordance with the present teachings, such as an Acumen™ Surgical Navigation System…. The Acumen™ Surgical Navigation System can operate in a variety of imaging modes such as a fluoroscopy mode creating a two-dimensional x-ray image, a computer-tomography (CT) mode creating a three-dimensional image, and an imageless mode creating a virtual image or planes and axes by defining anatomical points of the patient's anatomy.”).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER J MUTCHLER whose telephone number is (571)272-8012. The examiner can normally be reached M-F 7:00 am - 4:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer McDonald can be reached at 571-270-3061. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/C.J.M./Examiner, Art Unit 3796
/Jennifer Pitrak McDonald/Supervisory Patent Examiner, Art Unit 3796
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