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 .
Status of Claims
Claims 1-20 have been examined.
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).
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Claims 115 and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 11 of U.S. Patent No. 11,114,199. Although the claims at issue are not identical, they are not patentably distinct from each other because both claims recite a workflow controller configured to access a pre-scripted workflow or prescribed steps in workflow having a plurality of workflow steps associated with the surgical procedure.
Claims 1, 15 and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 11 of U.S. Patent No. 11,114,199. Although the claims at issue are not identical, they are not patentably distinct from each other because both claims recite a workflow controller configured to access a pre-scripted workflow or prescribed steps in workflow having a plurality of workflow steps associated with the surgical procedure
Claims 1, 15 and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 11 of U.S. Patent No. 12,349,988. Although the claims at issue are not identical, they are not patentably distinct from each other because both claims recite a workflow controller configured to access a pre-scripted workflow or prescribed steps in workflow having a plurality of workflow steps associated with the surgical procedure
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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 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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Lang (US 20170258526 ).
With respect to claim 1, Lang teaches a head-mounted device (HMD) comprising:
a head-mountable structure (‘526; Para 0004);
a camera supported by the head-mountable structure (‘526; Para 0050: FIG. 11 illustrates how a virtual surgical plan can be generated using intraoperative data, e.g. intra-operative measurements, for example measurements obtained with one or more cameras, an image capture system or a video capture system integrated into, attached to or separate from an optical head mount display);
a display supported by the head-mountable structure and being positionable in front of eyes of a user of the HMD (‘526; Para 0004: a simultaneous visualization of live data of the patient, e.g. a patient's spine or joint, and digital representations of virtual data such as virtual cuts and/or virtual surgical guides including cut blocks or drilling guides through an optical head mounted display (OHMD). In some embodiments, the surgical site including live data of the patient, the OHMD, and the virtual data are registered in a common coordinate system); and
a controller (‘526; Para 0674-0675) configured to:
obtain surgical procedure information (‘526; Para 0156; head movement can be used to control a surgical instrument. For example, in a robot assisted procedure with haptic feedback from the robot, the surgeon can use his or her hands in controlling the direction of a surgical instrument. The surgeon can move the head forward. This forward motion is captured by an IMU and translated into a forward movement of a robotic arm holding a surgical instrument along the direction of the surgical instrument.) ;
determine, based on the surgical procedure information, a prescribed arrangement of one or more surgical objects in an operating room to facilitate a surgical procedure for a patient (‘526; Para 0430: If more than one optical marker are used, the optical markers can be arranged at predefined angles and locations, e.g. 90 degrees or less than 90 degrees or more than 90 degrees. The insert can have similar dimensions to a representative saw blade used with the cutting block or guide. The insert can indicate the position, location, orientation, alignment and direction of travel for a saw blade that will subsequently be inserted.); and
provide, on the display and in front of the eyes of the user, a computer-generated image to guide the user of the HMD to arrange the one or more surgical objects in the operating room according to the prescribed arrangement, wherein the computer-generated image is combined with, or overlaid on, real-world views (‘526; Para 0295: the computer or monitor displays shows a pre-operative or intra-operative imaging study of the patient, these can be displayed in 2D (e.g. cross-sectional) or 3D using pseudo-3D display techniques, for example with surface reconstruction and shading. Overlaying or superimposing, for example, a true 3D, e.g. stereoscopic 3D, view of the anatomy from the pre- or intra-operative imaging study and/or virtual surgical plan of the patient using the OHMD display onto the same anatomic structures and/or virtual surgical plan displayed in 2D or pseudo 3D by the standalone or separate computer or display monitor can be beneficial for the surgeon as he or she executes surgical plans or plans next surgical plans during a procedure.).
Claims 15 and 20 are rejected as the same reason with claim 1.
With respect to claim 2, Lang teaches the HMD of claim 1, wherein the surgical procedure information comprises information from a pre-operative surgical plan specific to the patient (‘526; Para 1295: when the computer or monitor displays shows a pre-operative or intra-operative imaging study of the patient, these can be displayed in 2D (e.g. cross-sectional) or 3D using pseudo-3D display techniques, for example with surface reconstruction and shading. Overlaying or superimposing, for example, a true 3D, e.g. stereoscopic 3D, view of the anatomy from the pre- or intra-operative imaging study and/or virtual surgical plan of the patient using the OHMD display onto the same anatomic structures and/or virtual surgical plan displayed in 2D or pseudo 3D by the standalone or separate computer or display monitor can be beneficial for the surgeon as he or she executes surgical plans or plans next surgical plans during a procedure).
With respect to claim 3, Lang teaches the HMD of claim 2, wherein the pre-operative surgical plan comprises a type of procedure for the patient and identification of an operative side of the patient (‘526; Para 1295).
With respect to claim 4, Lang teaches the HMD of claim 2, wherein the pre-operative surgical plan comprises surgeon preferences (‘526; Para 0886: surgeon preferences).
With respect to claim 5, Lang teaches the HMD of claim 1, wherein the controller is configured to determine the prescribed arrangement by being configured to match the surgical procedure information to one of a plurality of prescribed arrangements listed in a look-up table or database (‘526; Para 0150-0153).
Claim 16 is rejected as the same reason with claim 5.
With respect to claim 6, Lang teaches the HMD of claim 1, wherein the controller is configured to provide, on the display, the computer-generated image as an overhead layout plan of the operating room (‘526; Paras 0242-0243).
Claim 17 is rejected as the same reason with claim 6.
With respect to claim 7, Lang teaches the HMD of claim 1, wherein the computer-generated image is specifically tailored to responsibilities of the user of the HMD (‘526; Para 0032).
Claim 18 is rejected as the same reason with claim 7.
With respect to claim 8, Lang teaches the HMD of claim 1, wherein the prescribed arrangement relates to arrangement of a surgical tool in the operating room (‘‘526; Para 0076:surgical tool).
With respect to claim 9, Lang teaches the HMD of claim 1, wherein the prescribed arrangement relates to arrangement of a surgical robotic manipulator in the operating room (‘526; Paras 0139, 0156: an IMU or components thereof can be coupled with or registered with a navigation system or a robot, for example by registering a body or portions of a body within a shared coordinate system).
With respect to claim 10, Lang teaches the HMD of claim 1, wherein the prescribed arrangement relates to arrangement of a patient anatomy in the operating room (‘526; Para 0146: navigation system can be used in conjunction with an OHMD without the use of an IMU. For example, navigation markers including infrared markers, retroreflective markers, RF markers can be attached to an OHMD and, optionally, portions or segments of the patient or the patient's anatomy. The OHMD and the patient or the patient's anatomy can be cross-referenced in this manner or registered in one or more coordinate systems used by the navigation system and movements of the OHMD or the operator wearing the OHMD can be registered in relationship to the patient within these one or more coordinate systems).
With respect to claim 11, Lang teaches the HMD of claim 1, wherein the prescribed arrangement comprises workflow steps (‘526; Paras 0051: workflow for generating a virtual surgical plan; Para 0040: FIG. 2 shows a workflow for segmentation and select subsequent steps).
With respect to claim 12, Lang teaches the HMD of claim 11, wherein the controller is configured to: obtain, from the camera, camera data related to an environment of the operating room; monitor the camera data to detect a deviation or a potential deviation from one or more of the workflow steps; generate an instruction or a recommendation to assist the user in taking action to address the deviation or the potential deviation; produce an additional computer-generated image related to the instruction or the recommendation; and provide the computer-generated image on the display (‘526; Para 0675: to transmit or receive data or information back and forth from the one or more OHMDs to a control unit or computer, optionally with a user interface. In this example, LED's participating or connected in the one or more LIF networks can be integrated into or attached to the OHMD. LED's participating or connected in the one or more LIF networks can be attached to or, when applicable, integrated into any location or site on the surgeon, the OR staff, the patient, the surgical site, one or more OHMD's, one or more navigation systems, one or more navigation markers, e.g. retroreflective markers, infrared markers, RF markers; one or more optical markers, calibration or registration phantoms.).
Claim 19 is rejected as the same reason with claim 12.
With respect to claim 13, Lang teaches the HMD of claim 1, wherein: the camera is configured to generate real-world video of an environment of the operating room; and the controller is configured to combine the computer-generated image with the real-world video (‘526; Para 0032, Para 0050).
With respect to claim 14, Lang teaches the HMD of claim 1, wherein: the display is transparent to enable the user to see-through the display to observe an environment of the operating room; and the controller is configured to overlay the computer-generated image onto the display (‘526; Para 1295: he computer or monitor displays shows a pre-operative or intra-operative imaging study of the patient, these can be displayed in 2D (e.g. cross-sectional) or 3D using pseudo-3D display techniques, for example with surface reconstruction and shading. Overlaying or superimposing, for example, a true 3D, e.g. stereoscopic 3D, view of the anatomy from the pre- or intra-operative imaging study).
Conclusion
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/HIEP V NGUYEN/Primary Examiner, Art Unit 3686
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