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 .
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the claims at issue are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
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Claim(s) 1, 3-10, 15 and 16 is/are rejected on the ground of nonstatutory double patenting as being anticipated by claim(s) 7 of U.S. Patent No. 11849932. Although the claims at issue are not identical, they are not patentably distinct from each other because the difference between the application claims and the patent claims lies in the fact that the patent claims include many more elements and are thus much more specific as shown below (note that underlined and/or bolded sections indicate comparable elements):
Invention 19/232052
US Patent 11849932
1. A surgical retractor system, comprising: a retractor having a distal end for insertion into a surgical site of a patient to retract tissue, wherein an outer surface of the retractor engages the tissue and an inner surface of the retractor defines a working channel; a first sensor disposed on the outer surface of the retractor to gather data relating to a retracted tissue parameter and a second sensor disposed on the retractor, wherein the first sensor and the second sensor have different modalities; and a controller configured to: receive data from the sensors; and based on the received data, determine to output a command to the retractor or a command to a surgical robot arm operably attached to the retractor to: stimulate the retracted tissue; or move the retractor to alleviate pressure on the retracted tissue.
7. A surgical retractor system comprising: a retractor having a proximal end configured to couple to a surgical robot arm and a distal end for insertion into a surgical site of a patient to retract tissue, wherein an outer surface of the retractor engages the tissue and an inner surface of the retractor defines a working channel; a sensor coupled to the outer surface of the retractor, wherein the sensor is configured to gather data including a parameter related to force exerted on a nerve on the retracted tissue; and a controller operatively coupled to the sensor and at least one of the robot arm or the retractor, the controller configured to receive data from the sensor, and determine output at least one of a command to the retractor or a command to the surgical robot arm to: stimulate the retracted tissue; or move the retractor to alleviate pressure on the retracted tissue; wherein the sensor is a force sensor, a pressure sensor, an optical sensor, a temperature sensor, a strain gauge, a torque sensor, an ultrasound sensor, or a nerve health sensor; wherein at least two different modalities of sensors are coupled to the outer surface of the retractor.
3. The system of claim 1, wherein the received data represents a force exerted by the outer surface of the retractor on the retracted tissue.
Claim 7, see the bolded sections above, note pressure sensor and strain gauge
4. The system of claim 3, wherein the controller is further configured to determine a length of time the retracted tissue is at or above a predetermined force.
Claim 7, see the bolded sections above and note that this device is capable of performing this function
5. The system of claim 1, wherein the received data represents a pressure exerted by the outer surface of the retractor on the retracted tissue.
Claim 7, see the bolded sections above, note pressure sensor and strain gauge
6. The system of claim 5, wherein the controller is further configured to determine a length of time the retracted tissue is at or above a predetermined pressure.
Claim 7, see the bolded sections above and note that this device is capable of performing this function
7. The system of claim 1, wherein the received data represents a blood flow in the retracted tissue.
Claim 7, see the bolded sections above, note optical sensor
8. The system of claim 1, wherein the received data represents a blood oxygenation in the retracted tissue.
Claim 7, see the bolded sections above, note optical sensor
9. The system of claim 1, wherein the received data represents a temperature variation in the retracted tissue.
Claim 7, see the bolded sections above, note temperature sensor
10. The system of claim 1, wherein the received data represents a health of a nerve in the retracted tissue.
Claim 7, see the bolded sections above, note nerve health sensor
15. The system of claim 1, wherein the first sensor is a pressure sensor, and wherein the controller is further configured to determine a length of time the retracted tissue is at or above a predetermined pressure, and when the determined time exceeds a threshold, to output the command to the retractor or the command to the surgical robot arm.
Claim 7, see the bolded sections above
16. The system of claim 1, wherein the controller is further configured to generate an alert.
Claim 7, see the bolded sections above and note that this device is capable of performing this function
Thus, the invention of US Patent 111849932, claim 7, respectively, is in effect a “species” of the “generic” invention of the application claims. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since the application claims are anticipated by the patent claims, they are not patentably distinct from the patent claims.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 3-6 and 11-13 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Friedrich (US 20180132839).
With respect to claim 1, Friedrich discloses a surgical retractor system (see para. 8), comprising: a retractor (2010) having a distal end (e.g., at blades 2012) for insertion into a surgical site of a patient to retract tissue (see para. 152, fig. 20 below), wherein an outer surface of the retractor engages the tissue and an inner surface of the retractor defines a working channel (see para. 152, fig. 20 below); a first sensor (e.g., 2070) disposed on the outer surface of the retractor to gather data relating to a retracted tissue parameter (e.g., amount of force/torque, see para. 153 below) and a second sensor disposed (e.g., another of 2070, see para. 154-157) on the retractor (see para. 24), wherein the first sensor and the second sensor have different modalities (e.g., force and/or torque, see para. 156 and note that measuring a pushing force is a different modality to measuring a twisting force); and a controller (2050) configured to: receive data from the sensors (see fig. 20 below); and based on the received data, determine to output a command to the retractor or a command to a surgical robot arm operably attached to the retractor to: stimulate the retracted tissue; or move the retractor to alleviate pressure on the retracted tissue (see para. 157, 175).
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As for claim 3, Friedrich further discloses the system of claim 1, wherein the received data represents a force exerted by the outer surface of the retractor on the retracted tissue (see para. 151-158).
As for claim 4, Friedrich further discloses the system of claim 3, wherein the controller is further configured to determine a length of time the retracted tissue is at or above a predetermined force (see para. 151-158 and note that this is a functional recitation that this device is capable of performing this function if one so desires).
As for claim 5, Friedrich further discloses the system of claim 1, wherein the received data represents a pressure exerted by the outer surface of the retractor on the retracted tissue (see fig. 20 above and note force and/or torque sensors 2070).
As for claim 6, Friedrich further discloses the system of claim 5, wherein the controller is further configured to determine a length of time the retracted tissue is at or above a predetermined pressure (see para. 151-158 and note that this is a functional recitation that this device is capable of performing this function if one so desires).
As for claim 11, Friedrich further discloses the system of claim 1, wherein the controller command to the surgical robot arm to move the retractor includes a fine adjustment of the retractor placement comprising at least one of a three-dimensional position, configuration, rotation, or angulation to alleviate pressure on the retracted tissue while allowing continued access to the working channel (see para. 181-185).
As for claim 12, Friedrich further discloses the system of claim 1, wherein the controller command to move the retractor causes a change in diameter of the working channel (see para. 181-185).
As for claim 13, Friedrich further discloses the system of claim 1, wherein the retractor includes a plurality of retractor blades, and wherein the controller command to move the retractor causes at least one of the plurality of retractor blades to change position (see para. 181-185).
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) 7-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Friedrich (US 20180132839), as applied to claim 1 above, in view of Zand (WO2006113394A2).
As for claims 7-10, Friedrich does not appear to teach wherein the received data represents a blood flow in the retracted tissue; wherein the received data represents a blood oxygenation in the retracted tissue; wherein the received data represents a temperature variation in the retracted tissue; and wherein the received data represents a health of a nerve in the retracted tissue.
Zand, also drawn to sensors used with surgical instruments for detecting tissue properties (see abstract below), teaches wherein the received data represents a blood flow in the retracted tissue (see para. 112); wherein the received data represents a blood oxygenation in the retracted tissue (see para. 112); wherein the received data represents a temperature variation in the retracted tissue (see para. 112); and wherein the received data represents a health of a nerve (e.g., determined by nerve activity) in the retracted tissue (see para. 112) in order to allow a surgeon to assess a physical condition of the subject tissue and/or guide a procedure being performed on the tissue (see abstract below).
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the sensor of Friedrich wherein the received data represents a blood flow in the retracted tissue; wherein the received data represents a blood oxygenation in the retracted tissue; wherein the received data represents a temperature variation in the retracted tissue; and wherein the received data represents a health of a nerve in the retracted tissue, in view of Zand, in order to allow a surgeon to assess a physical condition of the subject tissue and/or guide a procedure being performed on the tissue.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Friedrich (US 20180132839) in view of Miles (US 20080097164).
With respect to claim 14, Friedrich teaches a surgical retractor system (see para. 8), comprising: a retractor (2010) having a distal end (e.g., at blades 2012) for insertion into a surgical site of a patient to retract tissue (see para. 152, fig. 20 below), wherein an outer surface of the retractor engages the tissue and an inner surface of the retractor defines a working channel (see para. 152, fig. 20 below); a first sensor (e.g., 2070) disposed on the outer surface of the retractor to gather data relating to a retracted tissue parameter (e.g., amount of force/torque, see para. 153 below) and a second sensor disposed (e.g., another of 2070, see para. 154-157) on the retractor (see para. 24), wherein the first sensor and the second sensor have different modalities (e.g., force and/or torque, see para. 156 and note that measuring a pushing force is a different modality to measuring a twisting force); and a controller (2050) configured to: receive data from the sensors (see fig. 20 below); and based on the received data, determine to output a command to the retractor (e.g., to move the retractor, see para. 157, 175).
Friedrich does not appear to teach the limitation: or a command to a surgical robot arm operably attached to the retractor to: stimulate the retracted tissue; wherein the controller command to the retractor to stimulate the retracted tissue causes the retractor to output one or more of vibrations, thermal energy, or electrical stimulations.
Miles, also drawn to surgical retractor systems (see abstract), teaches the use of sensors (electrodes) in order to provide known sensors (electrodes) to a command neuromonitoring and stimulation to a surgical target site distracted by the retractor (see para. 39-44 and fig. 15-16) and provide an improved manner of atraumatically establishing a distraction corridor (see para. 42).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the sensors of Friedrich to include the ability to command to a surgical robot arm operably attached to the retractor to: stimulate the retracted tissue; wherein the controller command to the retractor to stimulate the retracted tissue causes the retractor to output one or more of vibrations, thermal energy, or electrical stimulations, in view of Miles, in order to provide known sensors to command neuromonitoring and stimulation to a surgical target site distracted by the retractor and provide an improved manner of atraumatically establishing a distraction corridor.
Claim(s) 15-18 and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Friedrich (US 20180132839), as applied to claim 1 above, in view of Xia (US 20110184245).
As for claims 15-18, Friedrich further teaches wherein the first sensor is a pressure sensor (see para. 156) and to output a command to the retractor or the command to the surgical robot arm (see para. 156, fig. 20 above), but does not appear to teach wherein the controller is further configured to determine a length of time the retracted tissue is at or above a predetermined pressure, and when the determined time exceeds a threshold; wherein the controller is further configured to generate an alert; wherein the alert is generated when a force applied by the retractor exceeds a threshold; and wherein the controller is further configured to determine a length of time, and wherein the alert is generated when one or more of a time of retractor deflection exceeds a threshold, or a pressure applied by the retractor over a given time exceeds a threshold.
Xia, also drawn to tissue monitoring surgical retraction systems (see abstract), teaches wherein the controller is further configured to determine a length of time the retracted tissue is at or above a predetermined pressure, and when the determined time exceeds a threshold (see para. 31); wherein the controller is further configured to generate an alert (see para. 31); wherein the alert is generated when a force applied by the retractor exceeds a threshold (see para. 31); and wherein the controller is further configured to determine a length of time (see para. 31), and wherein the alert is generated when one or more of a time of retractor deflection exceeds a threshold, or a pressure applied by the retractor over a given time exceeds a threshold (see para. 31) in order to assess and provide an indication of trauma levels above a preset threshold during a surgical procedure (see para. 31).
It would have been obvious to one of ordinary skill in art before the effective filing date of the invention to modify Friedrich wherein the controller is further configured to determine a length of time the retracted tissue is at or above a predetermined pressure, and when the determined time exceeds a threshold; wherein the controller is further configured to generate an alert; wherein the alert is generated when a force applied by the retractor exceeds a threshold; and wherein the controller is further configured to determine a length of time, and wherein the alert is generated when one or more of a time of retractor deflection exceeds a threshold, or a pressure applied by the retractor over a given time exceeds a threshold, in view of Xia, in order to assess and provide an indication of trauma levels above a preset threshold during a surgical procedure.
With respect to claim 21, Friedrich discloses a surgical retractor system (see para. 8), comprising: a retractor (2010) having a distal end (e.g., at blades 2012) for insertion into a surgical site of a patient to retract tissue (see para. 152, fig. 20 below), wherein an outer surface of the retractor engages the tissue and an inner surface of the retractor defines a working channel (see para. 152, fig. 20 below); a first sensor (e.g., 2070) disposed on the outer surface of the retractor to gather data relating to a retracted tissue parameter (e.g., amount of force/torque, see para. 153 below) and a second sensor disposed (e.g., another of 2070, see para. 154-157) on the retractor (see para. 24); and a controller (2050) configured to: receive data from the sensors (see fig. 20 below); and based on the received data, and output a command to the retractor or a command to a surgical robot arm operably attached to the retractor to: stimulate the retracted tissue (see para. 157, 175); or move the retractor to alleviate pressure on the retracted tissue (see para. 157, 175).
Friedrich does not appear to teach the controller determine: a length of time the retracted tissue is at or above a predetermined parameter value.
Xia, also drawn to tissue monitoring surgical retraction systems (see abstract), teaches wherein the controller is further configured to determine a length of time the retracted tissue is at or above a predetermined pressure, and when the determined time exceeds a threshold (see para. 31) in order to assess and provide an indication of trauma levels above a preset threshold during a surgical procedure.
It would have been obvious to one of ordinary skill in art before the effective filing date of the invention to modify Friedrich wherein the controller is further configured to determine a length of time the retracted tissue is at or above a predetermined pressure, in view of Xia, in order to assess and provide an indication of trauma levels above a preset threshold during a surgical procedure.
Claim(s) 19 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Friedrich (US 20180132839) and Xia (US 20110184245), as applied to claim 16 above, in further view of Lee (US 9795367).
As for claims 19 and 20, Friedrich, as modified by Xia, further teaches wherein the alert is generated when a pressure above a threshold is applied to, or within a predetermined range of, a tissue (see para. 31); or wherein the alert is generated when one or more of a tissue health deteriorates below a threshold (see para. 31), a maximum elongation limit of a tissue is reached (see para. 31 below), a temperature in the retracted tissue exceeds a threshold, or blood oxygenation or blood flow in the retracted tissue falls below a threshold. Friedrich, as modified by Xia does not appear to teach wherein the tissue is a nerve.
Lee, also drawn to tissue monitoring surgical retraction systems (see abstract), teaches wherein the tissue is a nerve (see abstract and col. 3 lines 17-25, 30-35 and col. 7 lines 18-40) in order to allow the surgeon to monitor the nerves by tracking the amount of pressure applied to the nearby tissue and/or nerves by the retractor, as is well known in the art (see col. 7 lines 23-40).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Friedrich, as modified by Xia, wherein the tissue is a nerve, in view of Lee, in order to allow the surgeon to monitor the nerves by tracking the amount of pressure applied to the nearby tissue and/or nerves by the retractor, as is well known in the art.
Response to Arguments
Applicants’ arguments filed 8/25/2026 have been fully considered but they are not persuasive.
The rejection of claim 14 has been updated to reflect the amendment to claim 14. Previously, claim 14 was dependent upon claim 1 which provided two “or” stipulations in lines 9-12: “based on the received data, determine to output a command to the retractor or a command to the robot arm operably attached to the retractor to: stimulate the retracted tissue; or move the retractor to alleviate pressure on the retracted tissue.”, with claim 14 further limiting the first part of the second “or” clause. In the Non-Final rejection mailed on 5/12/2026, the “or move the retractor to alleviate pressure on the retracted tissue” clause was selected. The amendment removes this clause from claim 14 and the teaching provided by Miles is used teach the “stimulate” limitation as stated in the rejection to claim 14 above.
Applicant argues (see Remarks page 7) that because a Double Patenting Rejection was not made between two previously pending parent cases, the Double Patenting Rejection in this case should not be made between US Patent 11849932 and the invention. This is not found to be persuasive as the relationship being argued between the parent cases has no bearing to the Double Patenting Rejection concerning the invention.
Applicant further argues that Friedrich does not disclose “wherein the first sensor and the second sensor have different modalities” (see Remarks page 7-8). This is not found to be persuasive as Friedrich teaches two sensors (note there are multiple sensors 2707, see para. 153) that each provides one or both of measuring a pushing force and/or a twisting force. Pushing and twisting are different types of measurements, and thus, have different modalities.
The rejection of claims 1, 3-13 and 15-20 is maintained. Newly presented claim 21 has been rejected.
Conclusion
Applicants’ amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicants are 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.
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/TARA ROSE E CARTER/Examiner, Art Unit 3773 /EDUARDO C ROBERT/Supervisory Patent Examiner, Art Unit 3773
