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 .
Response to Arguments
Applicant’s arguments, see page 6, filed 06JUL2026, with respect to the rejection(s) of claim(s) 1 and 11 under 35 U.S.C. § 103 have been fully considered and are moot in view of new grounds of rejection prompted by Applicant’s amendment to claims. A new ground(s) of rejection is made in view of Korman in view of Schneider, with Schneider teaching a system for aligning surgical tools based on detected anatomy.
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.
Claim(s) 1, 5-8, 11, 17, 18, and 21-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20250017676 A1 (Korman et al.) in view of US 20190000563 A1 (Schneider et al.).
Regarding Claim 1, Korman teaches a delivery device (10) (Fig. 1 showing the overall system with Fig. 6A focusing on the surgical arm) comprising:
a conveyor (20);
one or more imaging devices (22) configured to have an eye of a patient in a field of view thereof ([0140] describing use of the imaging device to view the patient’s eye and provide said image for the operator);
a needle assembly comprising a needle (tools (21) comprising at least syringe (48) of the plurality of taught in [0142]);
a staging assembly (35) mounted to the conveyor (Fig. 6A), the conveyor configured to move the staging assembly in three-dimensional space ([0094] describing movement in three-dimensional space with the use of platform (110)), the staging assembly including one or more actuators (120) and configured to position the needle assembly relative to the eye of the patient ([0141] describing positioning of the needle, as well as [0147] describing placement of the needle relative the eye of the patient); and
a controller (one or more computer processors, via which components of the system interact [0007]) coupled to the conveyor, the one or more imaging devices, and the staging assembly (the computer processor configured to drive the conveyor [0082], operating the needle [0086], and providing control of the imaging device [0140])), the controller configured to:
receive one or more images from the one or more imaging devices (acquiring images [0140]);
detect a location of anatomy of the eye of the patient in the one or more images (visually analyzing the incision region [0174], inserting the needle into the eye through an incision region [0083]); and
activate the one or more actuators to drive the needle into a placement location on the eye of the patient according to the selected entry point [0083].
Korman teaches the selection of an entry point based on an incision region within the eye and control of the device based on said incision region, but fails to explicitly teach that the entry point is based on the detected location of anatomy itself.
Schneider teaches a system for determining the position and orientation of a tool relative to eye tissue of interest [Abstract] wherein eye anatomy is used to create reference markers for a procedure [0022], allowing the creation of virtual boundaries which prevents undesired damage to the tissue [0018].
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Korman to incorporate the anatomy detection for incision location of Schneider to reduce undesired damage [Schneider 0018].
Regarding Claim 5, Korman further teaches the conveyor has at least five degrees of freedom (the three dimensions of the XYZ system, as well as the pitch and yaw of the staging assembly [0014]).
Regarding Claim 6, Korman further teaches the conveyor is a robotic arm (being considered a robotic arm, as seen in Fig. 6A).
Regarding Claim 7, Korman further teaches the needle assembly (21) is configured to force fluid through the needle into the eye (via injector tools [0140]).
Regarding Claim 8, Korman further teaches a fixation target (incision point or incision zone as described in [0017] that is fixed relative to the staging assembly (the site being a fixed location and the system controlling operation based on the remote center of motion (RCM) that coincides with the incision region [0168]), the controller being further configured to activate the one or more actuators to drive the needle into the placement location (actuation being controlled by the controller as discussed in Claim 1) in response to verifying fixation of the eye of the patient on the fixation target (the operator performing steps based on received images [0009]).
Regarding Claim 11, Korman teaches a method for drug delivery (utilizing delivery device (10)) (Fig. 1 showing the overall system with Fig. 6A focusing on the surgical arm) comprising:
activating, by a controller (one or more computer processors, via which components of the system interact [0007]), a conveyor (20) to transport a staging assembly (35) (Fig. 6A) toward an eye of a patient, the staging assembly having a needle assembly mounted thereto ([0141] describing positioning of the needle, as well as [0147] describing placement of the needle relative the eye of the patient);
receiving, by the controller, one or more images from one or more imaging devices mounted to the staging assembly [0140];
detecting a location of anatomy of an eye of the patient in the one or more images (visually analyzing the incision region [0174], inserting the needle into the eye through an incision region [0083]);
activating, by the controller, one or more actuators (120) of the staging assembly to align the needle assembly relative to the location of the anatomy [0083]; and
activating, by the controller, the one or more actuators to drive a needle mounted to the needle assembly into a placement location on the eye of the patient according to the location of the anatomy [0083].
Korman teaches the selection of an entry point based on an incision region within the eye and control of the device based on said incision region, but fails to explicitly teach that the entry point is based on the detected location of anatomy itself.
Schneider teaches a system for determining the position and orientation of a tool relative to eye tissue of interest [Abstract] wherein eye anatomy is used to create reference markers for a procedure [0022], allowing the creation of virtual boundaries which prevents undesired damage to the tissue [0018].
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Korman to incorporate the anatomy detection for incision location of Schneider to reduce undesired damage [Schneider 0018].
Regarding Claim 17, Korman further teaches the needle assembly (21) is configured to force fluid through the needle into the eye (via injector tools [0140]).
Regarding Claim 18, Korman further teaches activating, by the controller, a fixation target (incision point or incision zone as described in [0017] that is fixed relative to the staging assembly (the site being a fixed location and the system controlling operation based on the remote center of motion (RCM) that coincides with the incision region [0168]), the controller being further configured to activate the one or more actuators to drive the needle into the placement location (actuation being controlled by the controller as discussed in Claim 1) in response to verifying fixation of the eye of the patient on the fixation target (the operator performing steps based on received images [0009]).
Regarding Claims 21-23, Korman fails to teach detecting the location of anatomy comprises identifying a limbus of the eye in the one or more images, and wherein the selected entry point is selected relative to the detected limbus, the selected entry point is selected based on a detected location of at least one of a lens or a retina of the eye to avoid damage to the at least one of the lens or the retina, or wherein the controller is further configured to generate a three-dimensional model of the eye, and wherein the selected entry point is selected based on the three-dimensional model.
Schneider further teaches detecting the location of anatomy comprises identifying a limbus of the eye in the one or more images, and wherein the selected entry point is selected relative to the detected limbus ([0022] teaching the detection of various anatomical features, which include the limbus);
wherein the selected entry point is selected based on a detected location of at least one of a lens or a retina [0024] of the eye to avoid damage to the at least one of the lens or the retina [0018];
wherein the controller is further configured to generate a three-dimensional model of the eye [0016, 0018], and wherein the selected entry point is selected based on the three-dimensional model [0018].
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Korman to incorporate the anatomy detection for incision location of Schneider to reduce undesired damage [Schneider 0018].
Claim(s) 1, 5-8, 11, 17, 18, and 21-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Korman in view of Schnieder, and further in view of US 20050049486 A1 (Urquhart et al.).
Regarding Claim 2, Korman fails to teach clamping actuators configured to restrict movement of a head of the patient.
Urquhart teaches a delivery device (10) (Fig. 1) wherein clamping actuators are configured to restrict movement of a head of the patient, screw driver (104) (Fig. 8B) performing adjustments to control head movement/retention and therefore considered a clamping actuator [0075], the one or more clamping actuators are mounted to a support to which the conveyor is mounted.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Korman in view of Schneider to incorporate the clamping actuators of Urquhart to allow automatic adjustment of the head [Urquhart 0075].
Regarding Claim 12, Korman fails to teach activating, by the controller, one or more clamping actuators, to restrict movement of a head of the patient.
Urquhart teaches a delivery device (10) (Fig. 1) wherein clamping actuators are configured to restrict movement of a head of the patient, screw driver (104) performing adjustments to control head movement/retention and therefore considered a clamping actuator [0075], the one or more clamping actuators are mounted to a support to which the conveyor is mounted.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Korman in view of Schneider to incorporate the clamping actuators of Urquhart to allow automatic adjustment of the head [Urquhart 0075].
Claim(s) 3, 4, 13, and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Korman in view of Schneider and Urquhart, and further in view of US 20200297358 A1 (Cameron et al.)
Regarding Claim 3, Korman in view of Schneider and Urquhart fails to teach the one or more clamping actuators are mounted to the conveyor, the conveyor configured to move the one or more clamping actuators in the three-dimensional space.
Cameron teaches a delivery device (100) (Fig. 1B) wherein a stereotactic frame ((134) corresponding to the clamping actuators of Korman in view of Urquhart) are mounted to the conveyor (106) ([0048] describing connection to (106)).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the clamping actuators of Korman in view of Schneider and Urquhart by mounting said actuators to the conveyor as taught by Cameron to prevent relative movement of the patient with respect to components of the robot during surgery [Cameron 0048].
As Korman teaches movement in three-dimensional space to control device placement [0012], the combined device is considered to teach a conveyor configured to move the one or more clamping actuators in the three-dimensional space.
Regarding Claim 4, Korman in view of Schneider and Urquhart fails to teach the one or more clamping actuators are mounted to a support to which the conveyor is mounted.
Cameron teaches a delivery device (100) (Fig. 1B) wherein a stereotactic frame ((134) corresponding to the clamping actuators of Korman in view of Urquhart) wherein the one or more clamping actuators are mounted to a support (107) to which the conveyor (106) is mounted.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the clamping actuators of Korman in view of Schneider and Urquhart by mounting said actuators to a support to which the conveyor is mount as taught by Cameron to prevent relative movement of the patient with respect to components of the robot during surgery [Cameron 0048].
Regarding Claim 13, Korman in view of Scheider and Urquhart fails to teach the one or more clamping actuators are mounted to the conveyor, the conveyor configured to move the one or more clamping actuators in the three-dimensional space.
Cameron teaches a delivery device (100) (Fig. 1B) wherein a stereotactic frame ((134) corresponding to the clamping actuators of Korman in view of Urquhart) are mounted to the conveyor (106) ([0048] describing connection to (106)).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the clamping actuators of Korman in view of Schneider and Urquhart by mounting said actuators to the conveyor as taught by Cameron to prevent relative movement of the patient with respect to components of the robot during surgery [Cameron 0048].
As Korman teaches movement in three-dimensional space to control device placement [0012], the combined device is considered to teach a conveyor configured to move the one or more clamping actuators in the three-dimensional space.
Regarding Claim 14, Korman in view of Schneider and Urquhart fails to teach the one or more clamping actuators are mounted to a support to which the conveyor is mounted.
Cameron teaches a delivery device (100) (Fig. 1B) wherein a stereotactic frame ((134) corresponding to the clamping actuators of Korman in view of Urquhart) wherein the one or more clamping actuators are mounted to a support (107) to which the conveyor (106) is mounted.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the clamping actuators of Korman in view of Schneider and Urquhart by mounting said actuators to a support to which the conveyor is mount as taught by Cameron to prevent relative movement of the patient with respect to components of the robot during surgery [Cameron 0048].
Claim(s) 9 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Korman in view of Schneider, and further in view of US 20200188612 A1 (Brown et al.).
Regarding Claim 9, Korman fails to teach the controller is further configured to activate the one or more actuators to drive the needle into the placement location in response to an authorization received from a remote observer over a network.
Brown teaches a surgical system (100) wherein the controller (processor [0137]) is further configured to activate the one or more actuators (operating conduits (44) or other tools in the system [0137]) in response to an authorization received from a remote observer over a network (allowing the system to be controlled remotely, as well as executing commands received from a practitioner [0137]).
The combined device is therefore considered to be configured to activate the one or more actuators to drive the needle into the placement location in response to an authorization received from a remote observer over a network.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Korman in view of Schneider to allow remote authorization and control as taught by Brown to allow a practitioner to operate a system remotely [Brown 0136].
Regarding Claim 19, Korman fails to teach the controller is further configured to activate the one or more actuators to drive the needle into the placement location in response to an authorization received (by the controller) from a remote observer over a network.
Brown teaches a surgical system (100) wherein the controller (processor [0137]) is further configured to activate the one or more actuators (operating conduits (44) or other tools in the system [0137]) in response to an authorization received from a remote observer over a network (allowing the system to be controlled remotely, as well as executing commands received from a practitioner [0137]).
The combined device is therefore considered to be configured to activate the one or more actuators to drive the needle into the placement location in response to an authorization received from a remote observer over a network.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Korman in view of Schneider to allow remote authorization and control as taught by Brown to allow a practitioner to operate a system remotely [Brown 0136].
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Korman in view of Schneider, and further in view of US 20240058079 A1 (Kim et. al.).
Regarding Claim 10, Korman teaches the use of worm gear (134) to control pitch which would result in arcuate movement, but teaches control of yaw through rotation about a central axis [0160, 0162], and therefore fails to teach the one or more actuators include two arcuate actuators and a linear actuator.
Kim teaches a delivery device (10) (Fig. 1) comprising a plurality of linear actuators (32, 36, 40) and a plurality of arcuate actuators (50, 31, 38, 42) [0023] for controlling movement with five degrees of freedom [0055].
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the actuators of Korman to include two or more arcuate and linear actuators in order to provide movement with five degrees of freedom [Kim 0055].
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
US 20210228292 A1 discloses a system and method for automated robotic intraocular surgery.
US 20090161827 A1, US 20210228284 A1, and US 20150335480 A1 disclose image-based robotic medical systems.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HANS KALIHER whose telephone number is (303)297-4453. The examiner can normally be reached Monday-Friday 08:00-05:00 MT.
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/HANS KALIHER/Examiner, Art Unit 3781
/JESSICA ARBLE/Primary Examiner, Art Unit 3781
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