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 § 103
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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 3-7, 11, 13-16 and 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tolkowski et al. (US 2021/0386480) (“Tolkowski”), and further in view of Tillet et al. (US 2020/0146731) (“Tillet”) and Pojskic et al. (Intraoperative Computed Tomography-Based Navigation with Augmented Reality for Lateral Approaches to the Spine, MDPI, Brain Sci., 2021, 11, 646. https://doi.org/ 10.3390/brainsci11050646, Received: 20 April 2021, Accepted: 12 May 2021, Published: 15 May 2021) (“Pojskic”).
With regards to claim 1 and 17, Tolkowsky discloses a surgical navigation [0915] and planning system [0614] [0630][0900] and methods for use in procedures that are performed on skeletal anatomy [0005], comprising:
a display device (FIG. 1B; [0495]; display 30) [0608];
at least one processor (FIG. 1B; computer processor 22);
a non-transitory and tangible computer readable storage medium having programming instructions stored thereon [0957] [0960], which when executed by the at least one processor cause the at least one processor to:
receive patient-specific vertebrae information associated with a vertebrae level for treatment of a patient, the patient-specific vertebrae information comprising at least one image [0603][0604][0681];
determine a first path and orientation for an interbody implant from a first entry incision location to a location proximal the vertebrae level [0609][0614][0632][0640][0744][0747];
calculate, based on the first path, a first plurality of clearance distances between boundary dimensions of the interbody implant and the identified objects [0632][0653]; and
responsive to the first path navigating around the identified objects by at least a margin of error [0816][0913], cause the display device to display a surgical plan including the first path [0636][0744].
Tolkowsky discloses teaches that the surgical navigation system utilizes a sensor to distinguish between cortical bone, cancellous bone, nerves, blood vessels, etc. [0807].
Tolkowsky do not specifically disclose identifying a plurality of objects in least one image, the plurality of objects including a psoas muscle and vessels proximate to the psoas muscle.
Tillet discloses systems and methods for performing spine surgery, including minimally invasive lateral access spine surgery [0003]. Tillet teaches of a system 100 that utilizes a display device 219 to facilitate planning for a surgical procedure. The system and display device enables a surgeon to identify one or more target positions in the patient's body and/or a path or trajectory into the patient's body for inserting surgical tool(s) to reach a target position while minimizing damage to other tissue or organs of the patient [0025]. Further, the reference teaches of a surgical procedure that may be a robot-assisted spinal procedure, such as a minimally-invasive lateral transpsoas interbody fusion (FIGS. 3A-3E; [0051]). The procedure utilizes a motion tracking system ([0051]; FIG. 3B; 105) ([0027] teaches that the motion tracking system can be used on a robotic arm 101) comprising of an optical sensing device 111, two or more cameras 207 and a display device 219 used to display image data of the patient’s anatomy [0025]. The motion tracking device is used to track a marker device 319, an instrument 304, and to continuously track the position and/or orientation of the said instrument 304 relative to the patient 300 [0051]. The reference goes on to teach “… the user (e.g., surgeon) may manipulate the instrument 304 while viewing the augmented patient images on the display device 219 to identify a desired trajectory though the patient 300 to a surgical area. For example, for a lateral transpoas interbody fusion, the surgeon may utilize the instrument 304 to identify a path through the patient's anatomy to the surgical site (e.g., an intervertebral disc requiring a surgical intervention). The path may be selected to minimize disturbance to other anatomic features, such as neural structures (e.g., lumbar nerve plexus) located around or within the psoas muscle [0053].
In view of Tillet, it would have been obvious to one of ordinary skill within the art before the effective filing date of the claimed invention to modify the planning system of Tolkowsky with a method of imaging the psoa muscle and surrounding neural structures. The motivation is to allow the surgeon to observe, define target positions, and track the insertion of a surgical tool into a patient’s vertebrae. This method minimizes risk damage to surrounding neural structures as well as surrounding tissues and organs.
Tillet discloses that for common spinal surgery procedures, such as interbody fusion, surgical space is required to be accessed from the posterior or anterior of the patient. This may require removing bony portions of the vertebral column to access the disc space. This approach may risk damage to major vascular structures and other sensitive organs [0015].
Modified Tolkowsky do not specifically disclose identifying vessels proximate to the psoas muscle.
Pojskic discloses “Intraoperative Computed Tomography-Based Navigation with Augmented Reality for Lateral Approaches to the Spine” (Title). Pojskic teaches a XLIF (Extreme Lateral Interbody Fusion) procedure that uses a transpsoas approach can potentially lead to nerve injury and complications. “Safe working zones” for the placement of a retractor are located in the lumbar spine at L3, L2, or L1 and the psoas muscle should be split into the ventral three-quarters of the vertebral body to avoid nerve injury. Further, the reference teaches “Since vascular and lumbar plexus nerve injuries are a major cause of morbidity in the lateral approach to the spine [33], visualization of these structures is of vital importance for increasing the safety of the procedure.” The reference further discloses that iCT (intraoperative Computed Tomography) with AR (Augmented Reality) can be used to image such “safe-working zones” (pg. 19; 1st, 2nd and 3rd full para.). Finally, this approach can be utilized for automatic navigational registration and provides high accuracy with a target registration error of 0.84 +/- 0.10 mm (Abstract).
In view of Pojskic, it would have been obvious to one of ordinary skill within the art before the effective filing date of the claimed invention to modify the planning system of modified Tolkowsky with the capability of imaging and identifying the psoas muscle and surrounding vascular and lumbar plexus nerves of the vertebrae. The motivation is to image “safe-working zones” of the vertebrae in order to insert a surgical instrument with minimal risk to vascular (vessel) nerve damage.
With regards to claim 3, modified Tolkowsky discloses the surgical navigation and planning system of claim 1, wherein the programming instructions that cause the processor to identify the plurality of objects in the at least one image comprise programming instructions that cause the at least one processor to apply a trained neural network to the at least one image. (Tolkowsky; [0720])
With regards to claim 4, modified Tolkowsky discloses the surgical navigation and planning system of claim 1, wherein the programming instructions that cause the processor to cause the display device to display the surgical plan comprise programming instructions that cause the at least one processor to cause the display device to display the identified objects and the calculated clearance distances. (Tolkowsky; [0632][0634][0636])
With regards to claim 5, modified Tolkowsky discloses the surgical navigation and planning system of claim 1, wherein the margin of error is a programmable margin of error. (Tolkowsky; [0913][0952]) (Pojskic; Abstract)
With regards to claim 6, modified Tolkowsky discloses the surgical navigation and planning system of claim 1, wherein the programming instructions that cause the processor to identify the vessels proximate to the psoas muscle comprise programming instructions that cause the processor to identify an aorta (Pojskic; Figure 5).
With regards to claim 7, modified Tolkowsky discloses the surgical navigation and planning system of claim 1, wherein the computer readable storage medium further comprises one or more programming instructions that, when executed by the at least one processor cause the at least one processor to:
determine a second entry incision location (Tolkowsky; [0863][0864][0898]);
determine a second path for the interbody implant from the second entry incision location to the location proximal the vertebrae level (Tolkowsky; [0761][0762][0763]); and
calculate, based on the second path, a second plurality of clearance distances between the boundary dimensions of the interbody implant and the identified objects. (Tolkowsky; [0632])
With regards to claim 11, modified Tolkowsky disclose the surgical navigation and planning system of claim 1, wherein the computer readable storage medium further comprises one or more programming instructions that, when executed by the at least one processor cause the at least one processor to receive aggregated historical data comprising clinical outcomes of completed surgeries utilizing a substantially similar interbody device. (Pojskic; Abstract; Methods)
With regards to claim 13, modified Tolkowsky disclose the surgical navigation and planning system of claim 1, further comprising an imaging system including a source for generating X-rays and a detector for detecting X-rays that pass through the patient. (Tolkowsky; [0553])
With regards to claim 14, modified Tolkowsky disclose the surgical navigation and planning system of claim 13, wherein the computer readable storage medium further comprises one or more programming instructions that, when executed by the at least one processor cause the at least one processor to receive the patient-specific vertebrae information comprising the at least one image from the imaging system. (Tolkowsky; [0897]) (Pojskic; Abstract; Methods)
With regards to claim 15, modified Tolkowsky disclose the surgical navigation and planning system of claim 13, further comprising a navigation system configured to register the first path with the patient. (Tolkowsky; [0630][0652][0653][0659])(Tillet; [0052][0054][0058])
With regards to claim 16, modified Tolkowsky disclose the surgical navigation and planning system of claim 15, wherein the navigation system is further configured to track an instrument relative to the patient. (Tolkowsky; [0912]) (Tillet; [0020][0021])
With regards to claim 18, modified Tolkowsky disclose the method of claim 17, further comprising registering a navigation system with the patient. (Tolkowsky; [0008][0019]) (Tillet; [0020][0021])
With regards to claim 19, modified Tolkowsky disclose the method of claim 18, further comprising tracking the interbody implant along the corridor during the treatment of the patient. (Tolkowsky; [0912]) (Tillet; [0020][0021])
With regards to claim 20, modified Tolkowsky disclose the method of claim 18 further comprising displaying the tracked position of the interbody implant. (Tolkowsky; [0912])(Tillet; [0020][0021])
Allowable Subject Matter
Claims 2, 8-10 and 12 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
With regards to claim 2, modified Tolkowsky discloses the surgical navigation and planning system of claim 1, wherein the programming instructions further cause the at least one processor to:
determine a plurality of paths for the interbody implant from the first entry incision location to the location proximal the vertebrae level;
for each of the plurality of paths, calculate clearance distances between the boundary dimensions of the interbody implant and the identified objects; and
rank the plurality of paths based on the calculated clearance distances.
With regards to claim 8, modified Tolkowsky do not specifically disclose the surgical navigation and planning system of claim 1, wherein the computer readable storage medium further comprises programming instructions that, when executed by the at least one processor cause the at least one processor to:
compare the first plurality of clearance distances to the second plurality of clearance distances; and
rank the first path and the second path based on the comparison of the first plurality of clearance distances and the second plurality of clearance distances.
Claims 9-10 are objected due to being dependent on objected base claim 8.
With regards to claim 12, modified Tolkowsky do not disclose the surgical navigation and planning system of claim 1, wherein the computer readable storage medium further comprises one or more programming instructions that, when executed by the at least one processor cause the at least one processor to receive individual surgeon preferences.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Ma et al. (US 2021/0279868)
Abdou (US 10,973,648)
Udupa et al. (US 11,232,319)
Naidu et al. (US 2022/0401062)
Akyuz et al. (US 2011/0160585)
Shenai et al. (US 2011/0306873)
Zucker (US 2022/0142709)
Chen Liu et al. (A patient with left-sided inferior vena cava who received oblique lumbar interbody fusion surgery: a case report, Liu et al. Journal of Medical Case Reports (2020) 14:21, https://doi.org/10.1186/s13256-020-2342-y, Journal of Medical Case Reports
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/HUGH MAUPIN/ Primary Examiner, Art Unit 2884