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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/11/25 has been entered.
Response to Amendment
This action is responsive to the amendments 12/11/25. As directed, Claim 1 has been amended.
Information Disclosure Statement
The IDS filed 12/11/25 has been considered.
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.
Claim(s) 1-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lavrov et al. [WO 2021/077081, hereinafter “Lavrov] in view of Cameron et al. [US 2018/0325610 A1, hereinafter “Cameron”], and further in view of Steinberg [US 20020107573 A1, newly cited] and Link et al. [US 20190380789 A1, hereinafter “Link,” newly cited].
Re. claim 1, Lavrov discloses:
A robotic navigation system [Par. 0053] with a robotic arm [“robotic insertion tool,” Par. 0013, 0053, with the arm being the tool], (for identifying a target nerve within a surgical site for implanting a neuromodulation device within the surgical site: this is the intended use and not given further patentable weight), comprising:
a control system [“computer system”] configured to receive three-dimensional preoperative data comprising a spatial location of bone structures of two adjacent vertebrae within the surgical site [Pars. 0030-0034], the control system comprising a registration system configured to register a coordinate system of the robotic arm with the received three-dimensional preoperative data [that sub-system of the computer system which registers the 2D or 3D coordinates of Par. 0053], wherein the robotic arm is in operative connection and communication with the control system [Par. 0053];
a display screen [“one or more display elements,” Par. 0036] in operative connection and communication with the control system and configured to display the spatial location of the bone structures [Pars. 0035-0036];
wherein the control system is configured to calculate an estimated target nerve location based upon the three-dimensional preoperative data [Pars. 0049-0050], and wherein the control system is configured to display a virtual indicator of the calculated target nerve location on the display screen in the estimated target nerve location relative to the spatial location of the bone structures [Pars. 0047, 0050].
Lavrov further discloses the robotic arm is configured to receive instructions from the control system based on a preoperative plan based on the three-dimensional preoperative data and the calculated estimated target nerve location [“presurgical planning data,” Claim 7; see also Pars. 0030-0036], and
the control system is configured to position the robotic arm preoperatively according to the received instructions over a predetermined incision location [Par. 0053].
Lavrov is silent regarding the safety control system, the arm being positioned over a predetermined location with a predetermined angle, and the requiring of affirmative preoperative confirmation actuation steps.
Regarding the control system configured to position the robotic arm preoperatively according to the received instructions with a predetermined angle of entry, Steinberg teaches, in a robotic navigation surgical system, a control system configured to position the robotic arm preoperatively according to the received instructions with a predetermined angle of entry [Fig. 44A, Par. 1083: “cannula entry angle is extracted from the final real time starting operation plan (Step D in FIG. 44A). The required repositioning of central aperture 220 is carried out by operation of pistons 240 and 242 in response to control inputs supplied thereto by controller 252.”] It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system of Lavrov by configuring the control system to position the arm with a predetermined angle of entry, as taught by Steinberg, in order to ensure that the surgical implement is located at the desired orientation according to the operation plan.
Regarding the safety control system, Cameron teaches, in a robotic navigation surgical system, a safety control system [emergency stop system 300] in operative connection and communication with the control system and configured to be controlled by the control system [Par. 0064, 0066] It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of Lavrov by adding a safety control system as taught by Cameron in order to stop the surgery in case of an emergency [Cameron Par. 0064].
Regarding the control systems requiring affirmative confirmation, Cameron further teaches the control system comprises instructions requiring at least one affirmative preoperative confirmation steps of the preoperative position of the robotic arm from a surgeon prior to making the incision, and wherein the at least one affirmative preoperative confirmation includes the preoperative position of the robotic arm regarding the predetermined location of the incision and the predetermined angle of entry [Pars. 0148, 0149]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of Lavrov by configuring the control system to comprise instructions require a preoperative confirmation of the position and angle as taught by Cameron in order to improve the safety and accuracy of the system.
Regarding the control systems requiring separate, affirmative preoperative confirmation steps requiring separate actuation steps performed by the surgeon: Link teaches, in a control system for a surgical device, requiring separate actuation steps performed by the surgeon as affirmative preoperative confirmation steps [pressing key 240 at least twice to confirm position/angles, see Pars. 0073 and 0076. See also Pars. 0016-0017 and 0020 which describe the angles and position]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system of the modified Lavrov such that the system requires separate, affirmative preoperative confirmation steps requiring separate actuation steps performed by the surgeon, as taught by Link, to confirm the desired position and angle, in order to provide an extra layer of security/quality control.
Regarding the safety control system being the system to require the confirmation steps: this amounts to a rearrangement of parts (the program stored on a control system being stored specifically in the safety control system) which does not affect the operation of the device. See MPEP 2144.04.Vi.C. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system such that it is the safety control system to require the confirmation steps because this is the system which prevents/halts operation in the instance of emergencies [Cameron Par. 0064]
Claim 2. Lavrov further discloses wherein the target nerve is a dorsal root ganglion [Pars. 0049, 0058].
Claim 3. Lavrov further discloses wherein the target nerve is a spinal cord [Pars. 0047, 0050].
Claim 4. Lavrov further discloses, wherein the estimated target nerve location is based upon an MRI [Par. 0030].
Claim 5. Lavrov further discloses, wherein the calculated estimated target nerve location is based upon an estimated anatomical distance from the bone structures [Par. 0027].
Claim 6. Lavrov further discloses, wherein the calculated estimated target nerve location is based upon fiducial markers registered by the registration system [radio opaque markers, Par. 0022].
Claim 7. Lavrov further discloses, wherein the estimated target nerve location is using machine learning [Par. 0035], said machine learning providing said estimated target nerve location based upon an annotated training set of multiple bone structure images and target nerve locations [“machine learning…algorithm…that has been trained to map between anatomical measurement data and medical images…[for] example, an image can be input to a suitably trained machine learning algorithm, generating output as augmented spinal cord anatomy model data, which may include location outputs with respect to vertebrae,” Par. 0035. Note that in order to train the algorithm, more than one image must have been input, and must be annotated in some way including bone structures and target nerve locations. Furthermore, this is a product-by-process claim, and the machine learning algorithm of Lavrov will perform the same function.]
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lavrov in view of Cameron, Steinberg, and Link, as applied to claim 1 and further in view of Kaula et al. [US 20110184308 A1, hereinafter “Kaula”].
Re. claim 8, the modified Lavrov discloses the robotic navigation system of claim 1, but fails to teach the nerve location based on an evoked response. However, Kaula teaches, in a system for determining nerve location, an estimated target nerve location is based upon an evoked response [Par. 0047]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system of Lavrov by determining an estimated target nerve location based on an evoked response, as taught by Kaula, because this amounts to a simple substitution of one nerve location determining method (evoked response in Kaula) for another (the original in Lavrov) known in the art, with predictable results (Kaula’s evoked response “determin[es] nerve proximity and nerve direction to surgical instruments employed in accessing a surgical target site, as well as monitoring the status or health (pathology) of a nerve or nerve root during surgical procedures.,” Par. 0010]
Response to Arguments
Applicant's arguments filed 12/11/25 have been fully considered but they are not persuasive. Although the examiner agrees that Cameron fails to explicitly disclose separate confirmation steps, the examiner finds that this alone does not distinguish the invention over the prior art. Link, above, teaches separate confirmation steps. Furthermore, even if this were not positively recited in a reference, it is not clear that separating one step into two steps would result in a patentable distinction.
Conclusion
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/ERIN MCGRATH/Primary Examiner, Art Unit 3771