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 .
Election/Restrictions
Applicant’s election with traverse of Group II (claims 1-13) in the reply filed on June 19, 2026 is acknowledged. The traversal is solely on the grounds that claim 20 should be additionally included in Group II, as claim 20 is directed to a tool assembly, not a method. Applicant’s argument is persuasive and claims 1-13 and 20 are considered part of Group II. Claims 13-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1 and 13 are rejected under 35 U.S.C. 102(a)(1) or 102(a)(2) as being anticipated by U.S. Patent Application Publication No. 2018/0014890 (Stanton).
Regarding claim 1, Stanton discloses a surgical system (see Figs. 5A-5G) for performing a procedure on a vertebral body adjacent to a soft tissue (see paragraphs [0050] and [0051]), the surgical system comprising: a robotic manipulator (102, see paragraph [0051]); a dilator probe (509 or an inner stage of the dilator/cannula 505, see paragraphs [0056] and [0059]) configured to be attached to the robotic manipulator (see paragraph [0054] and Fig. 5B); a sleeve (entirety of dilator/cannula 505 or an outer stage of dilator/cannula 505, see paragraphs [0056] and [0059]) disposed coaxially around the dilator probe (see Fig. 5B) and releasably with the dilator probe (see paragraph [0062]); a navigation system (navigation/image guided surgery system, see paragraph [0051]) configured to track the vertebral body and define an insertion trajectory with respect to the vertebral body (see paragraphs [0040], [0051], and [0052], and Figs. 5A-5G); and one or more controllers configured to control the robotic manipulator to align the dilator probe and the sleeve to the insertion trajectory and advance the dilator probe and the sleeve along the insertion trajectory to penetrate the soft tissue (see paragraphs [0027], [0038], [0052], [0071], and [0074]); wherein after penetration of the soft tissue, the sleeve is configured to remain embedded in the soft tissue and the dilator probe is configured to be retracted such that the dilator probe disengages from the sleeve to enable the sleeve to create a working channel through the soft tissue (see paragraph [0062]).
Regarding claim 13, Stanton discloses wherein the soft tissue is located between the vertebral body and a skin layer (see paragraphs [0020], [0049], [0053]-[0057]) and wherein: the sleeve comprises a proximal end defining an opening (507) to facilitate access to the working channel (see paragraph [0054]); the sleeve comprises a distal end (508) opposite the proximal end, the distal end configured to abut the vertebral body (512) during or after penetration of the soft tissue (see paragraph [0060]); and the sleeve comprises a length defined between the proximal end and the distal end, wherein the length is greater than a distance between the vertebral body (512) and the skin layer (outer layer of patient 200, see Figs. 5A-5G) to enable access to the opening of the proximal end above the skin layer (see Figs. 5A-5G).
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 2 is rejected under 35 U.S.C. 103 as being unpatentable over Stanton in view of U.S. Patent Application Publication No. 2016/0030124 (Kishi).
Regarding claim 2, Stanton is silent regarding wherein the one or more controllers are configured to control the robotic manipulator to retract the dilator probe from the sleeve. However, Kishi discloses a surgical tool holding device wherein a controller (157) is configured to control a robotic manipulator (152) to retract a tool (see paragraphs [0077], [0087], [0093] and Abstract). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to have the one or more controllers configured to control the robotic manipulator to retract the probe from the sleeve in order to facilitate precise robotically controlled manipulation of the dilator probe rather than manual manipulation of the dilator probe.
Claims 3 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Stanton in view of Kishi, and further in view of U.S. Patent Application Publication No. 2013/0172905 (Iorgulescu).
Regarding claims 3 and 4, Stanton and Kirshi are silent regarding wherein the one or more controllers control the robotic manipulator to retract the dilator probe by being configured to constrain the dilator probe to the insertion trajectory during retraction (claim 3); and wherein the one or more controllers are configured to enable the dilator probe to deviate from the insertion trajectory in response to detection of the dilator probe exiting the soft tissue (claim 4). However, Iorgulescu discloses a computer-assisted robotic surgical system in which a controller constrains motion of a tool (103) of the system to a limited trajectory (see paragraphs [0027]-[0029] and [0048]), and the controller allows the tool to deviate from the trajectory in response to detection of the tool exiting away from soft tissues a patient (see paragraph [0048]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to have the one or more controllers configured to constrain the dilator prove to an insertions trajectory until the probe is detected as having exited soft tissues as suggested by Iorgulescu in order to facilitate keeping the probe along a preferred trajectory when the probe is near tissue of a patient and capable of damaging the patient tissue, while allowing the probe to be removed from the trajectory and the patient once the probe is safely away from patient tissue and not a threat to damaging the tissue.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Stanton.
103 over Stanton.
Regarding claim 5, Stanton appears to disclose the dilator probe configured to be manually retracted from the sleeve be a user (see paragraph [0058]). Alternatively, Stanton discloses that assembly tools are configured to be manually inserted and removed by a user (see paragraphs [0035], [0036], [0058], and [0064]), and it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the dilator probe to be manually retracted from the sleeve by a user as Stanton suggests manual manipulation of the tools by a surgeon facilitates operation of the system on a patient (see Stanton, paragraphs [0035], [0036], [0058], and [0064]).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Stanton in view of U.S. Patent Application Publication No. 2016/0235492 (Morard).
Regarding claim 6, Stevenson is silent regarding wherein: the navigation system is configured to detect a change in pose of the vertebral body and adjust the insertion trajectory to account for the change in pose; and the robotic manipulator is configured to autonomously move the dilator probe and the sleeve to maintain alignment of the dilator probe and the sleeve to the adjusted insertion trajectory. However, Morard discloses a system for precise placement of tools during spinal surgery (see Abstract), wherein a navigation system (108) is configured to detect a change in pose of the patient’s body and adjust an insertion trajectory to account for the change in pose (see paragraphs [0098] and [0101]); and a robotic manipulator (102) is configured to autonomously move to maintain alignment with an adjusted insertion trajectory (see paragraph [0101]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the system of Stevenson to have the navigation configured to detect a change in pose of a patient’s vertebral body and adjust the insertion trajectory to account for the change in pose, and the robotic manipulator be configured to autonomously move the prove and sleeve to maintain alignment with the adjusted insertion trajectory as suggested by Morard in order to ensure proper insertion of surgical tools that accounts for patient movement (see Morard, paragraph [0101]).
Claims 7 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Stanton in view of U.S. Patent Application Publication No. 2011/0092850 (Kulkarni).
Regarding claims 7 and 8, Stanton discloses wherein the dilator probe includes a shaft (513, e.g.), but is silent regarding wherein the dilator probe and the sleeve include complementary locating features configured to axially hold the dilator probe and the sleeve relative to one another using a defeatable frictional engagement (claim 7); wherein the dilator probe includes a seal disposed annularly about the shaft, wherein the seal is configured to engage an inner surface of the sleeve (claim 8). However, Kulkarni discloses a surgical system (see Abstract) that includes a sleeve (800) and a probe (94 or 90), wherein the probe and the sleeve include complementary locating features (816; annular groove for receiving ring 816, see paragraph [0074]) configured to axially hold the probe and the sleeve relative to one another using a defeatable frictional engagement (see paragraph [0072]); wherein the probe includes a seal (816) disposed annularly about a shaft (94 or 90, e.g.) (see paragraphs [0071]-[0074]), wherein the seal is configured to engage an inner surface (808/810, see paragraphs [0071]-[0074]) of the sleeve (800). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the sleeve and probe of Stanton to have complementary features (seal and inner surface groove, e.g.) that frictionally, but not permanently, holds the probe and sleeve relative to each other as suggested by Kulkarni in order to prevent unintended movement of the probe within a patient via provisional, frictional locking engagement of the probe and sleeve together (see Kulkarni, paragraphs [0071]-[0074]).
Claims 9-12 are rejected under 35 U.S.C. 103 as being unpatentable over Stanton in view of U.S. Patent Application Publication No. 2014/0257332 (Zastrozna).
Regarding claim 9, Stanton appears to disclose wherein the sleeve (505) comprises a distal section that tapers in from a first diameter to a second diameter less than the first diameter (see tapering end of sleeve 505, Figs. 5A-5G; see also tapering end of corresponding sleeve 105, Figs. 1A and 1B). Alternatively, Zastrozna discloses a dilating cannula (70) that has a distal section (80) that tapers from a first diameter to a second diameter less than the first diameter (see paragraph [0030]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the sleeve to have a tapered distal section as suggested by Zastrozna in order to facilitate dilating of soft tissues during insertion of the sleeve in a patient (see Zastrozna, paragraph [0030])
Regarding claim 10, Stanton discloses wherein a distal section (508) of the sleeve includes at least one spike that is configured to penetrate the vertebral body (see paragraph [0060]).
Regarding claim 11, Stanton discloses wherein: the dilator probe includes a shaft (509 or inner stage of 505 are shafts with diameters) with a diameter; the distal section of the sleeve includes an opening (507) that is sized to the diameter of the shaft (see paragraph [0056]); and when the dilator probe and the sleeve are engaged to one another, the shaft is configured to occupy the opening to prevent ingress of the soft tissue (see paragraph [0056] and Fig. 5C; shaft and opening have substantially corresponding diameters; thus, the shaft can fill the opening to prevent ingress of soft tissue).
Regarding claim 12, Stanton discloses wherein: the dilator probe includes a shaft (513) and a tip (511) located at an end of the shaft; the distal section of the sleeve includes an opening (507); and when the dilator probe and the sleeve are engaged to one another, the tip of the dilator probe extends through the opening such that the tip is configured to assist in penetration of the soft tissue (see Fig. 4C and paragraphs [0057]-[0059]).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Stanton in view of Kishi, Zastrozna, and Kulkarni.
Regarding claim 20, Stanton discloses a tool assembly (505/509) for a robotic manipulator (102), the tool assembly comprising: a dilator probe (509 or an inner stage of the dilator/cannula 505, see paragraphs [0056] and [0059]) including a shaft (inner stage body of dilator/cannula 505 or 513) having a diameter and comprising a proximal end (513) and a distal end (511), wherein the distal end comprises a tip (511); and a sleeve (entirety of dilator/cannula 505 or an outer stage of dilator/cannula 505, see paragraphs [0056] and [0059]) configured to be disposed coaxially around the dilator probe (see Figs. 5A-5G), the sleeve comprising a distal section that defines an opening (507) sized to the diameter of the shaft (see paragraph [0056] and Fig. 5C; shaft and opening have substantially corresponding diameters); and when the dilator probe and the sleeve are axially held relative to one another, the shaft of the dilator probe is configured to occupy the opening and the tip is configured to extend through the opening beyond the distal section (see Figs. 5A-5G and paragraphs [0057]-[0059]).
Stanton is silent regarding wherein the proximal end of the dilator probe comprises an interface that is configured to attach to the robotic manipulator. However, Kishi discloses a surgical tool holding device wherein a tool (120) has an interface configured to attach to a robotic manipulator (152/153) for manipulation by the robotic manipulator (see paragraphs [0075], [0077], [0087], [0093] and Abstract). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to have the dilator probe have an interface configured to attach to the robotic manipulator in order to facilitate precise robotically controlled manipulation of the dilator probe rather than manual manipulation of the dilator probe.
Stanton appears to disclose wherein the sleeve (505) comprises a distal section that is tapered (see tapering end of sleeve 505, Figs. 5A-5G; see also tapering end of corresponding sleeve 105, Figs. 1A and 1B). Alternatively, Zastrozna discloses a dilating cannula (70) that has a distal section (80) that tapers from a first diameter to a second diameter less than the first diameter (see paragraph [0030]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the sleeve to have a tapered distal section as suggested by Zastrozna in order to facilitate dilating of soft tissues during insertion of the sleeve in a patient (see Zastrozna, paragraph [0030]).
Stanton is silent regarding wherein the dilator probe and the sleeve include complementary locating features configured to axially hold the dilator probe and the sleeve relative to one another using a defeatable frictional engagement. However, Kulkarni discloses a surgical system (see Abstract) that includes a sleeve (800) and a probe (94 or 90), wherein the probe and the sleeve include complementary locating features (816; annular groove for receiving ring 816, see paragraph [0074]) configured to axially hold the probe and the sleeve relative to one another using a defeatable frictional engagement (see paragraph [0072]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the sleeve and probe of Stanton to have complementary features (seal and inner surface groove, e.g.) that frictionally, but not permanently, holds the probe and sleeve relative to each other as suggested by Kulkarni in order to prevent unintended movement of the probe within a patient via provisional, frictional locking engagement of the probe and sleeve together (see Kulkarni, paragraphs [0071]-[0074]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICHOLAS J PLIONIS whose telephone number is (571)270-3027. The examiner can normally be reached on Monday - Friday, 10:00 a.m. - 6:00 p.m. EST.
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/NICHOLAS J PLIONIS/Primary Examiner, Art Unit 3773
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