DETAILED ACTION
This office action is responsive to the amendment filed August 10, 2026, and RCE filed September 10, 2026. Claims 1, 10, 12 and 17 were amended; claim 9 was canceled; and claim 21 was newly presented. Claims 1-8 and 10-21 are pending.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 September 10, 2026, has been entered.
Response to Arguments
Applicant's arguments filed August 10, 2026, have been fully considered but they are not persuasive.
The arguments first address the rejection under 35 USC 112(a) of all claims. The arguments state that the amendment to claim 1 was intended to overcome the rejection under 35 USC 112(a).
The issue is not the presence of the sensors, which applicant has helpfully identified at paragraphs [0064]-[0065]. The problem is the claim limitation "a sensor that detects that the robotic arm has received the surgical tool" at line 11 of the claim.
Examiner agrees that the sensor, being a force sensor, is clearly originally disclosed; Examiner disagrees that the determination of receipt of the surgical tool by the robotic arm was originally disclosed.
The emphasized citation at [0064] refers to the sensor's ability to permit a processor to "determine a precise pose in space of the robotic arm (as well as any object or element held by or secured to the robotic arm)". (examiner's emphasis) Determining a pose of a robotic arm (and a tool it does, or does not, carry) is not the same as determining receipt of the tool in (or by) the arm. This is simply insufficient teaching to provide support for the limitation of claim 1.
The emphasized citation at [0065] further is not considered to remedy this situation. The citation points to a teaching of "the sensor 126 may be a force sensor, configured to detect a force applied on the robot arm 116 (e.g. whether via an end effector of the robotic arm 116, a tool held by an end effector of the robotic arm 116, or otherwise).
Examiner reads this section and continues to be of the position that detecting a force applied to the robotic arm (or even to a tool held thereto) is not the same thing as determining receipt of that tool within the robot arm.
There is a link between what is disclosed and what is claimed that is simply incapable of being remedied by any of the originally presented specification, and especially not the sections identified by applicant in these remarks. The determination of receipt of the tool by the arm is a step which is different than all steps which the originally presented sensors were designed to carry out, and claiming such continues to be new matter.
The arguments then address the rejection of claim 1 under 35 USC 103 in view of Netravali et al. (US 2016/0038291) and Tierney (US 2018/0250080). The arguments are based on the claims, as amended. The arguments state that several claimed features are not taught or suggested. The argument then goes on to state that claim 9, now incorporated into claim 1, was previously indicated to be allowable. The argument appears to being applied equally to independent claims 12 and 17.
Examiner notes that the rejection also relied upon Vargas (US 2018/0168761), though such was not noted in the argument.
Examiner agrees that prior claim 9 is now incorporated into claims 1, 12, and 17, and was previously considered to contain allowable subject matter. Examiner has taken the opportunity afforded by the presentation of the RCE to reconsider. Examiner now believes amended claim 1 should continue to be rejected.
Claim 1 is to a system. The system has certain capabilities. While the combination of prior art does not demonstrate correlation between the shape of a custom shaped cavity to that of a head of a pedicle screw, Examiner sees no reason that the combination system is not capable of producing such a shaped cavity. Examiner notes that the pedicle screw is not positively recited, and only inferentially referred to. The rejection will be maintained.
Dependent claims were not individually argued, and are considered to stand or fall along with the independent claim from which they depend.
The rejections of record are maintained, below, as modified only to correlate to the amended claim language; or modified to correlate to examiner’s reconsideration.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-8 and 10-21 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Every claim now requires a sensor being a force sensor, which sensor ‘detects that the robotic arm has received the surgical tool’ (examiner’s emphasis). Examiner is of the position that this capability of this type of sensor was not originally disclosed, and further believes that insufficient detail is present as to how such a sensor is intended to function to achieve this result.
Sensor 126 is discussed at [0064-0066] and [0089]. The disclosure states that sensor 126 may be a force sensor “configured to detect a force applied on the robotic arm 116 (e.g. whether via an end effector of the robotic arm 116, a tool held by an end effector of the robotic arm 116, or otherwise).” At [0066], data from 126 may be used to “calculate a position in space of the robotic arm 116…” Sensor 126 may be used to measure the depth (of a bore) [0089].
Examiner does not find any originally presented disclosure which taught use of a force sensor for detecting that the robotic arm has received a surgical tool. This limitation is considered to be new-matter.
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 and 10-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tierney et al. (US 6,491,701 B2) in view of Netravali et al. (US 2016/0038291 A1) and Vargas et al. (US 2018/0168761 A1).
Regarding claims 1 and 10, Tierney teaches a system for performing a minimally-invasive surgical procedure comprising:
a processor (col. 3, lines 28-38);
a memory storing data for processing by the processor (col. 2, line 60 – col. 3, line 5), the data, when processed, causes the processor to:
determine that a robotic arm 58 has received a surgical tool 54 (fig. 4) through an arm guide 72 of the robotic arm 58 (col. 14, lines 23-39; see fig. 2B to indicate passing a tool 54 through cannula 72 and fig. 14C to indicate attachment of the tool 54 to the adapter 128; col. 17, lines 15-25); and
cause the robotic arm 58 to orient the surgical tool 54 in at least one direction along a trajectory (col. 7, line 61 – col. 8, line 7); and
a sensor that detects that the robotic arm has received the surgical tool (col. 14, lines 22-38; col. 4, line 31 – col. 5, line 17; col. 11, line 57 – col. 12, line 13).
Tierney fails to teach the processor causing the robotic arm to cause the surgical tool to remove at least a portion of an anatomical element to form a custom shaped cavity in the anatomical element, the cavity being shaped to seat a head of a pedicle screw; and fails to teach the sensor being a force sensor. However, Tierney does teach various cutter tools as the surgical tool. (col. 6, lines 40-57)
Netraveli teaches a system including a processor 10, a memory 12, and the processor causing a robotic arm [0021] S120, S150) to orient a surgical tool 20 in a direction along a trajectory to remove a portion of an anatomical element (bone/cartilage) to form an inferred custom shaped cavity 16 in the anatomical element [0028]. There is no reason the custom cavity cannot be shaped to seat a head of some inferred pedicle screw, or a pedicle screw with a tilted head.
It would have been obvious to one with ordinary skill in the art at the time of the invention to use the Tierney device to carry out the Netravali method. One would have done so by causing Tierney’s robotic arm and programming to conduct the cutting path taught by Netravali. One would have done so in order to produce a cavity 16 in a bone using a tool other than the tool taught by Netravali. One would have done so in a situation where the Netravali tool was not present for a surgeon to use.
The combination continues to fail to teach the sensor being a force sensor.
Vargas teaches a controller using information from a sensor (being a force sensor) [0067] to determine that the surgical tool is fully seated into the driver attachment [0067]:
“In some variations, transition from either the tool engagement state (208) or the tool readiness state (210) to the tool release state (212) may correspond to generation of a sensor signal from one or more surgical tool sensors corresponding to detachment between the surgical tool and the sterile adapter (234). For example, one or more projections (e.g., biasing pegs) of the tool driver may generate a sensor signal corresponding to at least one projection being biased toward a surface of the tool driver (e.g., the sterile adapter partially exerting a downward force against the tool driver) when being detached.”
It would have been obvious to one with ordinary skill in the art at the time of the invention to apply a force sensor to the Tierney device in order to provide the Tierney controller with additional knowledge of an attachment state of a tool. One would have done so in order to improve patient safety during the procedure being carried out by the Tierney device.
For sake of brevity, claims 1, 12 and 17 will be treated together, in the same manner as which they have been treated together in prior office actions and replies from applicant.
Specific to claim 17, Tierney has taught multiple arm guides carried by the surgical robot, which all together, will be considered to be the arm guide. Determination of each portion of the arm guide receiving and using a surgical tool 54 is considered within the scope of what is disclosed.
Regarding claims 2, 14 and 19, the inferred custom shaped cavity 16 has cross-sectional area larger than a cross-sectional area of the surgical tool 20 as seen at Netravali fig. 3A.
Regarding claims 3, 15 and 20, the at least one direction comprises a lateral direction and a depth direction (inherent to cause the tool 20 of Netravali to form the cavity 16 seen in fig. 3A).
Regarding claims 4 and 16, the system includes the arm guide 72, wherein the arm guide 72 comprises a depth stop (top surface of 72 as seen at fig. 2B) to prevent movement of the surgical tool past a predetermined depth (since 54 will not be able to pass the top surface of 72), and wherein the depth stop is adjustable (as by movement of 58).
Regarding claim 5, the memory stores further data for processing by the processor that, when processed, causes the processor to: cause the robotic arm to stop movement of the surgical tool at a predetermined depth (Netravali, [0029]-[0030]: custom instructions clearly include a depth element).
Regarding claim 6, the surgical tool 20 is configured to drill and mill the anatomical element.
Regarding claims 7 and 18, a reamer is known to be a tool for widening a hole. There is no reason that Netravali’s tool 20 cannot be used as a reamer. Netravali teaches that 20 is a rotary bit [0025] or milling tip [0028]. The memory stores further data (instructions as at [0029]-[0030] for processing by the processor 10 that, when processed, causes the processor to: determine that the robotic arm has received a drill bit 20 through the arm guide of the robotic arm; and cause the robotic arm to orient the drill bit 20 in one direction along a drill bit trajectory to form a bore in the anatomical element prior to removal of the at least the portion of the anatomical element by the reamer.
Regarding claim 11, the surgical tool 20 has a diameter larger than a cutting depth of the surgical tool 20 as seen at fig. 3A.
Regarding claims 13 and 21, there is no reason the combination method cited in rejecting claims 1 and 12 cannot be said to be minimally invasive.
Allowable Subject Matter
Claim 8 is 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. No prior art rejection is made related to this claim. The claim cannot be allowed until such time as the outstanding rejection under 35 USC 112 is overcome.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to David Bates whose telephone number is (571)270-7034. The examiner can normally be reached Monday through Friday, 10AM-6PM
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If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Kevin Truong, at (571)272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DAVID W BATES/Primary Examiner, Art Unit 3799
