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 § 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 and 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Thomas (US 2018/0303558) in view of Murphy, M.D. (US 2020/0375666).
Regarding claim 1, Thomas discloses a method for augmented reality for surgery (Thomas, [0006], “a method of using an augmented reality device”. In addition, in paragraph [0044], “the surgeon 501 may be wearing the augmented reality device 10. The augmented reality device 10 is another mechanism to provide the surgeon 501 with information to guide the surgery”), comprising:
using a physical registration object to determine a reference coordinate system for an augmented reality scene (Thomas, [0050], “a navigation coordinate system 702 tracks the position of objects in the real world space, including fiducial markers 710 mounted to a patient reference object 600 (FIG. 6)”. In addition, in paragraph [0049], “a registration process for the augmented reality device”. The patient reference object including fiducial markers is considered as the physical registration object and the navigation coordinate system is considered as a reference coordinate system), the physical registration object comprising at least one of a surgical implant, surgical instrument, or a surgical guide for the surgery (Thomas, [0050], “a navigation coordinate system 702 tracks the position of objects in the real world space, including fiducial markers 710 mounted to a patient reference object 600 (FIG. 6)”. In addition, in paragraph [0064], “a navigation system for optically-guided surgery”. The patient reference object including fiducial markers is considered a surgical guide for the surgery);
one or more virtual objects with respect to at least the physical registration object in the augmented reality scene (Thomas, [0051], “The registration process results in determining a first transform T1 between an image coordinate system 704 and the navigation coordinate system 702. This allows image data in the image coordinate system 704 to be converted to image data in the navigation coordinate system 702, which may then be rendered on a display screen together with tracked instruments and objects for which the navigation system determines a location in the real world”. In addition, in paragraph [0054], “the registration process for the augmented reality device includes rendering a model of a trackable real world object on the display. The model rendered in augmented reality matches the size and shape of the corresponding real world object”);
determining, using a sensor, a position of the physical registration object in the augmented reality scene (Thomas, [0045], “determining its position in the real world and then attempting to track its movement in the real world using various sensors”. In addition, in paragraph, [0050], “a navigation coordinate system 702 tracks the position of objects in the real world space, including fiducial markers 710 mounted to a patient reference object 600 (FIG. 6)”); and
displaying the one or more virtual objects within the augmented reality scene at a desired relative position with respect to the physical registration object (Thomas, [0044], “the augmented reality device 10 may render a model of the tool aligned directly with the real-world tool so that as the surgeon manipulates the tool into layers of the patient's brain and loses real-world sight of the tip of the tool, the modelled version still shows the position of the tip of the tool, which may further be supplemented by rendering on the augmented reality device 10 of a planned trajectory or other information to aid the surgeon 501 in guiding the tip of the tool”);
Thomas does not expressly disclose “receiving a surgical plan”;
Murphy, M.D. (hereinafter Murphy) discloses receiving a surgical plan (Murphy, [0012], “During a planning phase”);
an indication of desired relative position of one or more virtual objects with respect to at least a physical object (Murphy, [0012], “specific prosthetic components may be selected and their locations within the patient's body determined, e.g., to meet one or more goals of the surgery. 3D models of surgical tools, such as reamers and cup impactors, may be generated and their locations for implanting the selected components at the desired locations planned. The desired locations may be final locations, e.g., of a particular tool, or a sequence of locations, e.g., a tool path, from a starting point of a tool to its final location. At least some of the 3D models may be exported into a form that may be used by the head-mounted AR device to generate respective virtual images”).
the one or more virtual objects comprising at least part of an anatomy of a patient (Murphy, [0012], “anatomical structures may be prepared to receive the prosthetic components as planned, and the selected components may be implanted at the planned locations”);
displaying augmented reality scene based on the surgical plan (Murphy, [0016], “holograms of the one or more coordinate systems and/or guides for implanting one or more prosthetic components at the planned locations may be rendered by the AR device and appear as though they are in the surgical field in order to assist the surgeon in placing the prosthetic components”).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the augmented reality device in a surgical procedure of Thomas to incorporate the surgical guides disclosed in Murphy for implanting one or more prosthetic components at the planned locations. The motivation for doing so would have been improving accuracy and consistency in prosthetic placement.
Regarding claim 2, Thomas as modified by Murphy with the same motivation from claim 1 discloses a cutting guide (Murphy, [0345], “The cutting block 3300 provides an Anterior cutting guide 3402, a Posterior cutting guide 3405, and two angled chamfer cutting guides 3403 and 3404. A surgeon may place a saw blade 3406 in the cutting guides, e.g., the Anterior cutting guide 3402, of the cutting block 3300 to make the planned cuts”).
Regarding claim 3, Thomas as modified by Murphy with the same motivation from claim 1 discloses an anatomy of the patient comprises bone (Murphy, [0009], “recognize the registration and tracking device as configured for the patient and docked to the patient's anatomy, some portion of the patient's anatomy, such as a bone surface visisble through an incision”).
Regarding claim 4, Thomas as modified by Murphy with the same motivation from claim 1 discloses soft tissue (Murphy, [0323], “an anatomical measure, may check the ligament balance”).
Regarding claim 5, Thomas as modified by Murphy with the same motivation from claim 1 discloses anatomical landmarks (Murphy, [0367], “preparing the femur based purely on anatomical landmarks”).
Regarding claim 7, Thomas as modified by Murphy with the same motivation from claim 1 discloses a drilling trajectory (Murphy, [0422], “generate other, e.g., more sophisticated, holograms such as one showing the exact trajectory of a planned drill hole, or the exact size and location of the implant itself”).
Regarding claim 8, Thomas as modified by Murphy with the same motivation from claim 1 discloses a cutting plane (Murphy, [0346], “present holograms of the planned Anterior, Posterior, and angled chamfer cutting planes as planned. The surgeon may then check that these holograms of the cutting planes are co-located”).
Claims 6 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Thomas (US 2018/0303558) in view of Murphy, M.D. (US 2020/0375666), as applied to claim 1, in further view of Lang (US 2017/0258526).
Regarding claim 6, Thomas as modified by Murphy with the same motivation from claim 1 discloses surgical screws (Murphy, [0168], “determine where to insert one or more screws for holding the physical cup component in place”); Thomas as modified by Murphy does not expressly disclose “virtual surgical screws”;
Lang discloses virtual surgical screws (Lang, [0245], “The virtual data can also include a medical device, such as a pedicle screw, wherein the virtual data of the pedicle screw shows its intended location, orientation or path in relationship to the spine, and/or a pedicle, and/or a vertebral body”).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate Lang’s virtual surgical screw into the augmented reality display of Thomas as modified by Murphy. The motivation for doing so would have been improving the overall accuracy of the surgical procedure.
Regarding claim 9, Thomas as modified by Murphy and Lang with the same motivation from claim 6 discloses safety zones or margins where a procedure may be executed (Lang, [1530], “The area or volume that includes the click can be registered as a safety zone which the pedicle screw and any instruments used for the placement should not enter. A safety margin, e.g. of 2, 3, 4, 5, 7 or 10 mm can be added to the safety zone”).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Thomas (US 2018/0303558) in view of Murphy, M.D. (US 2020/0375666) in view of Lang (US 2017/0258526), as applied to claim 1, in further view of Edwards (Computer-Assisted Craniomaxillofacial Surgery, Oral Maxillofacial Surg Clin N Am, 2010).
Regarding claim 10, Thomas teaches using the sensor; Thomas as modified by Murphy and Lang with the same motivation from claim 6 discloses displaying a first block shape of a series block shapes based on determining that the physical block is in a first configuration (Lang, [1582], “FIGS. 19A-D provide an illustrative, non-limiting example of the use of virtual surgical guides such as a distal femoral cut block displayed by an OHMD and physical surgical guides such as physical distal femoral cut blocks”);
displaying a second block shape of the series of block shapes based on determining that the physical block is in a second configuration (Lang, [1586], “FIGS. 20A-C provide an illustrative, non-limiting example of the use of virtual surgical guides such as an AP femoral cut block displayed by an OHMD and physical surgical guides such as physical AP cut blocks for knee replacement”);
Thomas as modified by Murphy and Lang does not expressly disclose “a physical plate for craniomaxillofacial surgery”;
Edwards discloses a physical plate for craniomaxillofacial surgery (Edwards, Fig. 10 illustrates physical plate for craniomaxillofacial surgery)
a series of plate shapes (Edwards, Figs. 10-11 and 13-14 illustrate a series of plate shapes);
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to apply the techniques of Edwards’s craniomaxillofacial surgery to the orthopedic surgery procedures of Thomas as modified by Murphy and Lang. The motivation for doing so would have been improving surgical accuracy, planning and guidance in orthopedic procedures.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYLE ZHAI whose telephone number is (571)270-3740. The examiner can normally be reached 9AM-5PM.
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/KYLE ZHAI/ Primary Examiner, Art Unit 2611