DETAILED ACTION
Remarks
This non-final office action is in response to the CON application filled on 05/09/2025. Claims 1-20 are pending and examined below.
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 .
Priority
Acknowledgment is made of applicant’s claim for domestic benefit of provisional application No. 62/411,258, filed on Oct.21, 2016. Continuation of application No. 18/482,395, filed on Oct. 6, 2023, now Pat. No. 12,295,682, which is a continuation of application No. 17/352,505, filed on Jun. 21, 2021, now Pat. No. 11,806,100, which is a continuation of application No. 15/790,538, filed on Oct. 23, 2017, now Pat. No. 11,039,893.
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, 3, 5-8 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2015/0100066 (“Kostrzewski”), and further in view of US 2017/0165837 (“Asano”).
Regarding claim 1, Kostrzewski discloses a method for performing robotic-assisted surgery (see at least fig 1, where 102 is a surgical robot. see also fig 16, where robotic manipulator is used for surgery), the method comprising:
a robotic arm (see at least [0072], where "the surgical robot 102 includes a robotic arm mounted on a mobile cart”);
an end-effector configured to be attached to the robotic arm and hold a surgical tool (see at least [0072], where "The robotic arm may include a force control end-effector configured to hold a surgical tool");
an actuator to move the robotic arm and positioning of the end-effector (see at least [0072], where "The robot may be configured to control and/or allow positioning and/or movement of the end-effector"; see also [0098], where "Robot arm 310 is also attached to an
actuator that controls movement of the robotic arm and positioning of the end effector 314.
End effector 314 can position a surgical tool accurately and guide movement of the surgical tool. End effector 314 is configured to releasably hold a surgical tool and allows the surgical tool to be removed and replaced with another tool");
tracking markers configured to be attached to a patient (see at least [0013], where “the tracking detector monitors patient position by monitoring the position of one or more vertebrae, or markers placed in spatial relation to one or more vertebrae.”); and
a tracking detector configured to track the position of the tracking markers (see at least [0022] and [0078], where tracking detector 108 monitors the location of patient and surgical robot; see also [0073], where “tracking system tracks the position of the patient or the bone (e.g., by tracking the movement of the marker or position of the marker relative to the robot) as described in relation to FIGS. 1 and 3”; see also [0009]);
obtaining a real-time patient position from the tracking detector and a real-time end-effector position while a surgeon is manually moving the end-effector (see at least [0022] and [0078], where tracking detector 108 monitors the location of patient and surgical robot and surgeon is moving the end-effector manually for positioning. See also [0021], where “aligning (e.g., via force control mode operation) (e.g., manually, semi-manually, and/or automatically) the end effector in accordance with the computed and/or desired trajectory”);
determining whether the manually moving end-effector is within a (see at least [0014] and [0110], where the end-effector is allowed to move an identified distance in an identified direction);
upon determining that the end-effector position is within the (see at least [0026], [0068], ]0110], [0127] and [0160], where surgical system is controlled or actuator is allowed to move along the pre-planned trajectory); and
after the end-effector position has been aligned, performing an automatic and continuous motion compensation by maintaining the alignment of the end-effector position along the pre- planned trajectory (see at least [0078], where “the surgical robot 102 may also change its position and automatically position itself based on trajectories calculated from the real time patient and robotic arm positions captured using the tracking detector 108.”; see also [0074], where “the surgical robot 102 includes a robotic arm comprising joints allowing the arm to be automatically positioned upon user command into various different predetermined configurations convenient for various preparatory, readying, and storage procedures. For example, the surgical robot 102 may be arranged in a standby configuration”; see also [0022] and [0127], where robotic arm is moved toward a planned trajectory).
Kostrzewski does not disclose a threshold distance. However, Asano discloses a robotic surgical system wherein determine the instrument is within a threshold distance of the pre-planned trajectory (see at least [0154], [0155], [0158] and [0166]).
Before the effective filling date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have modified Kostrzewski to incorporate the teachings of Asano by including the above-mentioned feature of surgical robot control to enhance the precision of surgery and minimize the number of errors that occur during surgery.
Regarding claim 3, Kostrzewski further discloses a method wherein controlling the actuator to automatically take over and move the robotic arm includes moving the robotic arm to snap the end-effector into the pre-planned trajectory (see at least [0021], where “aligning (e.g., via force control mode operation) (e.g., manually, semi-manually, and/or automatically) the end effector in accordance with the computed and/or desired trajectory; and maneuvering the surgical tool into/onto patient tissue, wherein the surgical tool is constrained by the end effector (e.g., end effector is a drill bit tube, the surgical tool comprises a drill bit, and the drill bit is maneuvered through the tube). In certain embodiments, the robotic surgical system is an embodiment of the robotic surgical system described above or elsewhere herein. In some embodiments, the desired trajectory is determined automatically or semi-automatically, using a software algorithm and/or using input from the surgeon.”; see also [0074] and [0078]).
Regarding claim 5, Kostrzewski further discloses a method comprising inserting the surgical tool through a through hole of the end effector (see at least [0072]).
Regarding claim 6, Kostrzewski further discloses a method comprising inserting a drill bit as the surgical tool through a through hole of the end effector (see at least [0021] and [0122], where drill bit as surgical tool is described).
Regarding claim 7, Kostrzewski further discloses a method comprising inserting an awl as the surgical tool through a through hole of the end effector (see at least [0027] and [0122], where awl as surgical tool is described).
Regarding claim 8, Kostrzewski further discloses a method comprising inserting a pedicle screw in bone using the surgical tool held by the end-effector (see at least [0021] and [0137], where positioning of pedicle screw using a surgical tool is described).
Regarding claim 10, Kostrzewski further discloses a method comprising inserting a pedicle screw in bone using the surgical tool held by the end-effector while the end-effector is aligned along the pre-planned trajectory (see at least [0137]).
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2015/0100066 (“Kostrzewski”), and in view of US 2017/0165837 (“Asano”), as applied to claim 1 above, and further in view of US 2004/0016077 (“Song”).
Regarding claim 2, Asano further discloses a method wherein performing an automatic and continuous motion compensation includes: repeatedly calculating a difference between a planned position and an actual position of the end-effector relative to the patient (see at least [0155] and [0158]);
controlling the actuator to move the end-effector to the planned position if the calculated difference (see at least [0166], where 212 determines the difference between actual position and expected position. If the difference is above a predetermined threshold that is a sign of failure and correct the position of the robotic arm).
Kostrzewski in view of Asano does not disclose calculating a variance between positions. However, Song discloses a method wherein calculate a variance between the positions (see [0057], where "During the running of robot cleaner 10, the amount of the position variance of robot cleaner 10 is calculated by comparing the position information of the recognition mark appearing in the upper image received from the upper camera 14 with the memorized initial position value (Step 140).").
Before the effective filling date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have modified Kostrzewski in view of Asano to incorporate the teachings of Song by including the above feature, calculate a variance between the positions, for avoiding hurting patient during surgery by providing adjusted movement command.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2015/0100066 (“Kostrzewski”), and in view of US 2017/0165837 (“Asano”), as applied to claim 1 above, and in view of US 2004/0016077 (“Song”), as applied to claim 2 above, and further in view of US 9,675,272 (“Selover”).
Regarding claim 4, Kostrzewski in view of Asano and Song does not disclose claim 4. However, Selover discloses a method wherein controlling the actuator to move the end-effector to the planned position includes controlling the actuator to move if the calculated variance is greater than 0.5 cm (see column 21, lines 43-56, column 22, lines 3-10, where the offset of predetermined trajectory can be pre-programmed into determination module 202 and see also column 9, lines 39-41, where variance corresponds to deviance). Selover teaches that 3 or more degrees of position, including different distance thresholds can be determined for each instrument (column 21, line 4-column 22, line 33, see esp. column 21, lines 4-30 and column 22, lines 11-33). In this context, the threshold distance is presented as a results effective variable that may be optimized in a predictable manner to determine whether the instrument should be adjusted to match the instrument's trajectory to the predetermined trajectory (column 21, lines 4-30).
As explained in MPEP §§ 2143 and 2144.05(II), courts have recognized that where optimization of a results effective variable is within the level of ordinary skill in the art and may be carried out by combining prior art elements according to known methods to yield predictable results, it would have been obvious to a person of ordinary skill in the art to carry out such optimization. In the present case, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to optimize the distance threshold to include 3 or more degrees of precision with varying distance intervals in order to determine whether the instrument should be adjusted, as taught by Selover (column 21, line 4- column 22, line 33).
Claim(s) 9 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2015/0100066 (“Kostrzewski”), and in view of US 2017/0165837 (“Asano”), and further in view of US 2006/0247517 (“Labadie”).
Regarding claim 9, Kostrzewski in view of Asano does not discloses claim 9. However, Labadie discloses a method comprising determining a position of the surgical tool by tracking markers attached to the surgical tool (see at least fig 2, where 132 optical emitters attached with the surgical tool. See also [0060-62]).
Regarding claim 12, Kostrzewski in view of Asano discloses claim 12, see citation above in claim 1 except optical tracking marker. However, Labadie discloses a method comprising optical marker attached with to the patient (see at least fig 2, where 134 optical emitters attached with a skull. See also [0060-62]).
Before the effective filling date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have modified Kostrzewski in view of Asano to incorporate the teachings of Labadie by including the above-mentioned feature for avoiding any damage of patient body parts and surgical tools by assisting th surgeon to track the location of patient as well as surgical components.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2015/0100066 (“Kostrzewski”), and in view of US 2017/0165837 (“Asano”), as applied to claim 1 above, and further in view of US 2011/0087074 (“Hardenbrook”).
Regarding claim 11, Kostrzewski further discloses a method comprising inserting a screw/tool tool held by the end-effector while the end-effector is aligned along the pre-planned trajectory (see citation above). Kostrzewski in view of Asano does not disclose inserting an intervertebral spacer. However, Hardenbrook discloses a method wherein a tool is inserting an intervertebral spacer (see at least [0105]).
Before the effective filling date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have modified Kostrzewski in view of Asano to incorporate the teachings of Hardenbrook by including the above-mentioned feature for avoiding any immediate decompression of pinched nerves, restoration of natural disc height, and enhanced spinal stability.
Regarding claim 13, see citation on claim 2 above.
Regarding claim 14, see citation on claim 4 above.
Regarding claim 15, see citation on claim 5 above.
Regarding claim 16, see citation on claim 6 above.
Regarding claim 17, see citation on claim 7 above.
Regarding claim 18, see citation on claim 10 above.
Regarding claim 19, see citation on claim 9 above.
Regarding claim 20, see citation on claim 11 above.
Non-Statutory 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 conflicting claims 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); 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 nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP §§ 706.02(l) (1) - 706.02(l) (3) for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claim(s) 1, 7, 8, 12 and 17 is/are non-provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 9, 10 and 12 of US Patent No. 11,806,100.
This is a non-provisional non-statutory double patenting rejection since the claims directed to the reference patent have in fact been patented. Table below shows the claim matching between the application an issued patent:
Application No.
claims
claims
claim
19/203,773
1/12
7/17
8
17/352,505 (Patent No. 11,806,100)
1/12
9
10
Although the claims at issue are not identical, they are not patentably distinct from each other.
Claim(s) 1, 2, 4, 6-8 and 12-14 is/are non-provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 6, 8-10, 12, 13 and 17 of US Patent No. 12,295,682.
This is a non-provisional non-statutory double patenting rejection since the claims directed to the reference patent have in fact been patented. Table below shows the claim matching between the application an issued patent:
Application No.
claims
claims
claims
claim
Claim
claim
19/203,773
1/12
2/13
4/14
8
7
6
18/482,395 (Patent No. 12,295,682)
1/12
2/13
6/17
10
9
8
Although the claims at issue are not identical, they are not patentably distinct from each other.
Claim(s) 1, 2, 4, 6-8, 12 and 13 is/are non-provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 6-9, 11, 13 and 17 of US Patent No. 11,039,893.
This is a non-provisional non-statutory double patenting rejection since the claims directed to the reference patent have in fact been patented. Table below shows the claim matching between the application an issued patent:
Application No.
claims
claims
claims
claim
Claim
claim
19/203,773
1/12
2/13
4/14
8
7
6
15/790,538 (Patent No. 11,039,893)
1/11/17
2/13
6/17
9
8
7
Although the claims at issue are not identical, they are not patentably distinct from each other.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SOHANA TANJU KHAYER whose telephone number is (408)918-7597. The examiner can normally be reached on Monday - Thursday, 7 am-5.30 pm, PT.
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/SOHANA TANJU KHAYER/Primary Examiner, Art Unit 3657
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