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
DETAILED ACTION
Response to Amendment
Applicant’s amendment filed on 03/27/2026 has been entered. Claims 1-20 are still pending in this application.
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 1-7, 10-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ryan (US 20220160439) in view of Singh et al. (US 20230088370) and Smistad et al. (US 20220304653).
Regarding claim 1, Ryan teaches a computer-assisted surgical system, comprising:
a neuromonitoring probe configured to obtain neuromonitoring data regarding activity of a nerve in a patient (p0358:Probe (e.g., needle, injection, pin, screw, etc.) ); a navigation array attached to the neuromonitoring probe (p0267: sensor suite 210 can be used for navigation and p0290:the AR headset 3600 could be connected wirelessly to a neuromonitoring/nerve localization system, to provide the user 106 );
a tracking system to detect and track elements of the navigation array (p0269: optical tracking);
an augmented reality (AR) device (104 in fig. 1);
a robotic arm having a cutting instrument (p0003:cutting tools and p0300: cutting tool); and
a controller having at least one processor configured to:
receive neuromonitoring data from the neuromonitoring probe (p0290:patient's actual nerves have been imaged and reconstructed into 3D models, if the system detects that a particular nerve has been stimulated or is being approached by the stimulating probe);
receive probe positional data from the tracking system to determine a three-dimensional position and orientation of the neuromonitoring probe (p0358:The system 10 continues to track a position and an orientation of a probe)
correlate the neuromonitoring data to the positional data to determine neuromapping data indicating a nerve position in the patient (p0290: detects that a particular nerve has been stimulated or is being approached);
overlay a representation of the neuromapping data over three-dimensional position and orientation of the patient to establish a boundary around the nerve (p0290: the hologram representing that nerve structure can be highlighted to the user 106 to make it easier);
control the robotic arm to avoid the cutting instrument entering the boundary; and display the boundary on the AR device (p0290: nerve structure can be highlighted to the user 106 to make it easier to avoid contact with or injury to the nerve structure);use the neuromapping data to define a boundary around the nerve; associate the boundary with three-dimensional position and orientation of the patient (p0290: when used in conjunction with pre-operative imaging in which the patient's actual nerves have been imaged and reconstructed into 3D models, if the system detects that a particular nerve has been stimulated or is being approached by the stimulating probe, the hologram representing that nerve structure can be highlighted to the user 106 to make it easier to avoid contact with or injury to the nerve structure).
Ryan does not explicitly disclose overlay a representation of data to the overlay a representation.
Singh teaches overlay a representation of data to the overlay a representation (p0104: integrate that data with ultrasound data, and display the combined data on the ultrasound image (e.g., as an additional overlay or an adjacent image).
Ryan and Singh are combinable because they both deal with surgical procedure. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the application to combine the teachings of Ryan the teaching of Singh for purpose for determining safe passage through human tissue without damaging nearby neurovascular structures (p0002).
Ryan in view of Singh still does not teach nuromapping data to define a boundary around the nerve.
Smistad teaches nuromapping data to define a boundary around the nerve (abstract:processing the images to identify boundary features (4, 5, 6) representative of the boundaries of at least one of the optic nerve and the optic nerve ).
Ryan in view of Singh and Smistad are combinable because they both deal with surgical procedure. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the application to combine the teachings of Ryan in view of Singh the teaching of Smistad for purpose for for alignment of an ultrasound image obtained with an ultrasound probe for obtaining images in relation to the optic nerve or associated anatomical structures.
Regarding claim 2, Ryan teaches the system of claim 1, further comprising a second navigation array affixed to the patient or a surgical surface (600 in fig. 6).
Regarding claim 3, Ryan teaches The system of claim 1, wherein the view of the patient is image data from is a live video feed (p0230:video camera).
Regarding claim 4, Ryan teaches the system of claim 1, wherein the live video feed is from an endoscope (p0230:This would activate voice and video camera recording allowing the user 106).
Regarding claim 5, Ryan teaches the system of claim 1, wherein the view of the patient is image data from a 3D image (p0230:video camera recording allowing the user 106 to capture and narrate the complaint in 3D while the issue is occurring).
Regarding claim 6, Ryan teaches the system of claim 1, wherein the image is a 2D image (p0285: the 2D ultrasound image relative to the marker's 1300 Position).
Regarding claim 7, Ryan teaches the system of claim 1, wherein the controller is further configured to convey a warning if a predetermined threshold is exceeded (p0278:actual drill bit moves outside a safe target trajectory, the color of the virtual target 3400 changes to alert the user and an audible warning is emitted).
Regarding claim 10, claim 10 recites very similar limitations as claim1, therefore it is rejection for same reason as claim 1. In addition, teaches control the robotic arm to avoid the cutting instrument entering the boundary (00290: to avoid contact with or injury to the nerve structure); and display the boundary on the AR device (p0290: the hologram representing that nerve structure can be highlighted to the user 106 to make it easier to avoid contact with or injury to the nerve structure).
Regarding claim 11, Ryan in view Singh teaches wherein the boundary is displayed as an overlay image based on the neuromapping data (Singh: p0096-97: the B-mode overlay 450 of the psoas muscle, which the computer displays in color… instructs the computer to display location and proxmity information of any nerves in the psoas muscle within the view of the probe 12).
The rational applied to the rejection of claim 10 has been incorporated herein.
Regarding claim 12, Ryan in view of Singh teaches the system of claim 11, wherein the overlay image comprises a plurality of zones around the nerve (Singh: 450 in fig. 44).
The rational applied to the rejection of claim 10 has been incorporated herein.
Regarding claim 13, Ryan in view of Singh teaches the system of claim 12, wherein the overlay image comprises a first portion having a first appearance and a second portion having a second appearance (Singh: fig.45: 1, 2 and 3), wherein the second portion is more distal with respect to the nerve (Singh: fig. 45: 464).
The rational applied to the rejection of claim 10 has been incorporated herein.
Regarding claim 18, the limitations is same as limitations of claim 13, therefore it is rejected for the same reason as claim 13.
Regarding claim 14, Ryan in view of Singh teaches the system of claim 13, wherein the overlay image further comprises a third portion distal to the second portion to represent a margin (singh: p0097:the displayed nerve may be up to 120% or more of identified size to build in a safety margin).
The rational applied to the rejection of claim 11 has been incorporated herein.
Regarding claim 15, Ryan teaches the system of claim 10, wherein the controller is further configured to provide haptic feedback to a user when the cutting instrument comes within a predefined proximity to the boundary (p0278).
Regarding claim 16, claim 10 recites similar limitations as claim 16, therefore it is rejected for the same reason as claim 10, except when a user of the AR device is looking at the nerve position, display the boundary on the AR device as an overlay image over the real world view based on the neuromapping data.
Ryan further teaches when a user of the AR device is looking at the nerve position, display the boundary on the AR device as an overlay image over the real world view based on the neuromapping data (p00204: display device 104 for viewing by the user 106).
Regarding claim 17, Ryan teaches the system of claim 16, wherein the controller is further configured to perform at least one of: control the robotic arm to avoid the cutting instrument entering the boundary (p0290: nerve structure can be highlighted to the user 106 to make it easier to avoid contact with or injury to the nerve structure)); or provide haptic feedback to the user of the AR device when the cutting instrument comes within a predefined proximity to the boundary.
Claims 8-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ryan in view of Singh and Smisad as applied to claim 1 above, and further in view of Polidoro (US 7001361).
Regarding claim 8, Ryan in view of Singh and Smisad does not teach the system of claim 1, wherein the controller is further configured to receive temperature data from a temperature probe.
Polidoro teaches wherein the controller is further configured to receive temperature data from a temperature probe (col.7 Line:45-50: using a temperature or pressure probe to assess blood temperature or pressure in an vein or artery).
Ryan in view of Singh and Smisad and Polidoro are combinable because they both deal with surgical procedure. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the application to combine the teachings of Ryan in view of Singh and Smisad with the teaching of Polidoro for purpose of performing surgical procedures.
Regarding claim 9, Ryan in view of Singh and Smisad and Polidoro teaches the system of claim 1, wherein the controller is further configured to receive strain data from a pressure sensor (Polidoro: col.7 Line:45-50).
The rational applied to the rejection of claim 8 has been incorporated herein.
Claim 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ryan in view of Singh and Smisad, further in view of Visser (US 8519999).
Regarding claim 19, Ryan in view of Singh and Smisad does not teach the system of claim 18, wherein the first appearance and the second appearance differ in color.
Visser teaches wherein the first appearance and the second appearance differ in color (col.3 Lines:50-51: These segmented regions are usually rendered in a distinctive way, often using a different colour).
Ryan in view of Singh and Smisad and Visser are combinable because they both deal with surgical procedure. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the application to combine the teachings of Ryan in view of Singh with the teaching of Visser for purpose instantly recognizable within the image.
Claim 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ryan in view of Singh and Smisad, further in view of Nawana (US 20250186145 ).
Regarding claim 20, Ryan in view of Singh and Smisad does not teach the system of claim 16, wherein the controller is further configured to update the overlay image to account for a change in perspective of the user of the AR device.
Nawana teaches wherein the controller is further configured to update the overlay image to account for a change in perspective of the user of the AR device (p0055: updates the output image such that image is adjusted based on the user's head movement).
Ryan in view of Singh and Smisad and Nawana are combinable because they both deal with surgical procedure. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the application to combine the teachings of Ryan in view of Singh with the teaching of Nawana for purpose reduce a total number of operating rooms within a hospital as multiple operating rooms may be combined during a renovation (p0005).
Response to Arguments
Applicant's arguments with respect to claims have been considered but are moot in view of the new ground(s) of rejection.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HELEN Q ZONG whose telephone number is (571)270-1600. The examiner can normally be reached on Mon-Fri 9-6.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Merouan, Abderrahim can be reached on (571) 270-5254. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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HELEN ZONG
Primary Examiner
Art Unit 2683
/HELEN ZONG/Primary Examiner, Art Unit 2683
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