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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 11/22/2024 and 04/14/2026 are being considered by the examiner.
Claim Objections
Claim 3 is objected to because of the following informalities:
Claim 3, line 2, recites “connector for engaging the tracking array, the connector positioned toward the distal end of the” should read -- connector for engaging the tracking array, the connector positioned toward the proximal end of the --. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2, 10, and 18 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 2, the phrase "can be" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). The examiner interprets this to be “is configured to be visualized by a camera of the robotic navigation system allowing optical tracking and navigation of the dilator within the tissue protector and through soft tissue”.
Regarding claim 10, the phrase "may be" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). It is unclear if the applicant is actively claiming that the “the tissue protector is provided with various lengths and/or widths”. The examiner suggests modifying this to recite “wherein the tissue protector comprises various lengths and/or widths to accommodate surgical instruments and/or patient needs”.
Regarding claim 18, the phrase "can be" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). The examiner interprets this to be “is configured to be visualized by a camera of a robotic navigation system, allowing optical tracking and navigation of the dilator within the tissue protector and through soft tissue”.
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.
Claim(s) 1-12 and 17-20 is/are rejected under 35 U.S.C. 102(a)(1)/102(a)(2) as being anticipated by Wall et al. (US 20210228244 A1) herein referred to as “Wall”.
Regarding claim 1, Wall discloses a spinal surgical system (spinal implant system 10, Paragraph [0047]) comprising: a tissue protector comprising an elongate body having a proximal end, a distal end, and a lumen extending therethrough from the proximal end to the distal end (cannula 150, Figure 18-19, Paragraph [0064]); a dilator sized and shaped to be removably insertable into the lumen of the tissue protector (dilator 3, Figure 14, Paragraph [0052]), the dilator comprising an elongate body extending from a proximal end for separating tissue and a distal end (dilator 30 extends between a proximal end 32 and a distal end 34. Dilator defines a longitudinal axis X1, Paragraph [0050], Figure 4); and the dilator selectively engageable with a tracking array of a robotic navigation system and wherein the tissue protector is engageable with a robot of the robotic navigation system (dilator includes a mating element, for example, a bushing 42, bushing 42 is configured to connect a navigation component 280 with surgical instrument 12, Figures 3-4, Paragraph [0052]).
Regarding claim 2, Wall discloses the spinal surgical system of claim 1, wherein the tracking array of the robotic navigation system can be visualized by a camera of the robotic navigation system allowing optical tracking and navigation of the dilator within the tissue protector and through soft tissue (surface 130 is detectable by image guidance and utilized to determine a position of navigation component 280, and/or surgical instrument 12 during a surgical procedure, surface 130 is configured for connection with a portion of navigation component 280 to facilitate positioning and/or tracking of navigation component 280 and/or surgical instrument 12 during a surgical procedure, Paragraph [0052], Figure 1).
Regarding claim 3, Wall discloses the spinal surgical system of claim 1, wherein the dilator comprises a connector for engaging the tracking array (dilator includes a mating element, for example, a bushing 42, bushing 42 is configured to connect a navigation component 280 with surgical instrument 12, Figures 3-4, Paragraph [0052]), the connector positioned toward the distal end of the dilator (dilator includes a mating element, for example, a bushing 42, bushing 42 is configured to connect a navigation component 280 with surgical instrument 12, Figures 3-4, Paragraph [0052], bushing 42 is towards the proximal end of the dilator 32, Figure 3).
Regarding claim 4, Wall discloses the spinal surgical system of claim 1, wherein the tissue protector comprises a plurality of relief channels formed on an external surface of the elongate body to provide improved movement when traversing through soft tissue (passageway 38 is manufactured by milling overlapping slots 40 through surface 36 along dilator 30, Figure 4, Paragraph [0050]).
Regarding claim 5, Wall discloses the spinal surgical system of claim 4, wherein the relief channels are longitudinally arranged around the elongate body of the tissue protector (passageway 38 is manufactured by milling overlapping slots 40 through surface 36 along dilator 30, Figure 4, Paragraph [0050]).
Regarding claim 6, Wall discloses the spinal surgical system of claim 1, wherein the robotic navigation system provides real-time visualization and navigation of the dilator and tissue protector within soft tissue (navigation component 280 is configured to generate a signal representative of the anchor 14 relative to the tissue, Paragraph [0068], tracking system 316 can include various portions that are associated or included with surgical navigation system 306, in some embodiments tracking system 316 can also include an optical tracking system that includes an optical localizer, the information can be used by surgical navigation system 306 to allow for a display of position of an item such as a patient tracking device, Paragraph [0074]).
Regarding claim 7, Wall discloses the spinal surgical system of claim 1, wherein the robot of the robotic navigation system comprises a guide tube and wherein the tissue protector is insertable into the guide tube (surgical instrument 12 is configured for use with a guide member, for example, an end effector 200 of robotic arm R to determine axial trajectory of a surgical pathway and/or facilitate positioning of one or more instruments, implants, and/or components of spinal implant system 10 in alignment with the axial trajectory of a surgical pathway, Paragraph [0078], Figure 21, cannula is insertable into the guide tube 200, Figure 21).
Regarding claim 8, Wall discloses the spinal surgical system of claim 1, wherein the tissue protector has a distal end for engaging bone (drill guide 100 is mounted with anchor 14, Figure 19, end 104 of drill guide 100 extends from distal end of cannula 150 to engage bone B1, Paragraph [0082]).
Regarding claim 9, Wall discloses the spinal surgical system of claim 8, wherein the tissue protector has a toothed distal end (see end 104 of drill guide, Figure 19).
Regarding claim 10, Wall discloses the spinal surgical system of claim 1, wherein the tissue protector may be provided in various lengths and/or widths to accommodate surgical instruments and/or patient needs (surgical instrument 12 is inserted into cannula 150, Paragraph [0067]).
Regarding claim 11, Wall discloses the spinal surgical system of claim 1, wherein the dilator has a distal end for engaging bone (distal end of dilator is used to engage with bone B1, Figure 20, Paragraph [0080]).
Regarding claim 12, Wall discloses the spinal surgical system of claim 1, wherein the dilator has a distal end for traversing through soft tissue (end 34 includes a tapered configuration to facilitate spacing of tissue, Paragraph [0051], the term “tissue” includes soft tissue, Paragraph [0042]).
Regarding claim 17, Wall discloses a spinal surgical system (spinal implant system 10, Paragraph [0047]) comprising: a tissue protector comprising an elongate body having a proximal end, a distal end, and a lumen extending therethrough from the proximal end to the distal end (cannula 150, Figure 18-19, Paragraph [0064]), the tissue protector insertable through a guide tube of a robot (surgical instrument 12 is configured for use with a guide member, for example, an end effector 200 of robotic arm R to determine axial trajectory of a surgical pathway and/or facilitate positioning of one or more instruments, implants, and/or components of spinal implant system 10 in alignment with the axial trajectory of a surgical pathway, Paragraph [0078], Figure 21, cannula is insertable into the guide tube 200, Figure 21); a dilator sized and shaped to be removably insertable into the lumen of the tissue protector (tissue protector 150 receives the dilator 30, Figure 1), the dilator comprising an elongate body extending from a proximal end for passing through tissue and a distal end (dilator 30 extends between a proximal end 32 and a distal end 34. Dilator defines a longitudinal axis X1, Paragraph [0050], Figure 4); a tracking array selectively connectable to the dilator (dilator includes a mating element, for example, a bushing 42, bushing 42 is configured to connect a navigation component 280 with surgical instrument 12, Figures 3-4, Paragraph [0052]); and a scalpel handle insertable through the guide tube of the robot (a scalpel (not shown) is oriented for disposal with end effector 200 of robotic arm R, as described herein, Paragraph [0064]).
Regarding claim 18, Wall discloses the spinal surgical system of claim 17, wherein the tracking array can be visualized by a camera of a robotic navigation system (surface 130 is detectable by image guidance and utilized to determine a position of navigation component 280, and/or surgical instrument 12 during a surgical procedure, surface 130 is configured for connection with a portion of navigation component 280 to facilitate positioning and/or tracking of navigation component 280 and/or surgical instrument 12 during a surgical procedure, Paragraph [0052], Figure 1), allowing optical tracking and navigation of the dilator within the tissue protector and through soft tissue (surface 130 is detectable by image guidance and utilized to determine a position of navigation component 280, and/or surgical instrument 12 during a surgical procedure, surface 130 is configured for connection with a portion of navigation component 280 to facilitate positioning and/or tracking of navigation component 280 and/or surgical instrument 12 during a surgical procedure, Paragraph [0052], Figure 1, end 34 includes a tapered configuration to facilitate spacing of tissue, Paragraph [0051], the term “tissue” includes soft tissue, Paragraph [0042]).
Regarding claim 19, Wall discloses a spinal surgical system (spinal implant system 10, Paragraph [0047]) comprising: a tissue protector comprising an elongate body having a proximal end, a distal end, and a lumen extending therethrough from the proximal end to the distal end (cannula 150, Figure 18-19, Paragraph [0064]); a dilator sized and shaped to be removably insertable into the lumen of the tissue protector (tissue protector 150 receives the dilator 30, Figure 1), the dilator comprising an elongate body extending from a proximal end for separating tissue and a distal end (dilator 30 extends between a proximal end 32 and a distal end 34. Dilator defines a longitudinal axis X1, Paragraph [0050], Figure 4, end 34 includes a tapered configuration to facilitate spacing of tissue, Paragraph [0051]) and the dilator selectively engageable with a tracking array of a robotic navigation system (dilator includes a mating element, for example, a bushing 42, bushing 42 is configured to connect a navigation component 280 with surgical instrument 12, Figures 3-4, Paragraph [0052]).
Regarding claim 20, Wall discloses a method of forming a working channel for surgery, the method comprising: selecting a robot having a guide tube surgical instrument 12 is configured for use with a guide member, for example, an end effector 200 of robotic arm R to determine axial trajectory of a surgical pathway and/or facilitate positioning of one or more instruments, implants, and/or components of spinal implant system 10 in alignment with the axial trajectory of a surgical pathway, Paragraph [0078], Figure 21, cannula is insertable into the guide tube 200, Figure 21); selecting a scalpel with a scalpel handle that is sized and shaped to fit in the guide tube (a scalpel (not shown) is oriented for disposal with end effector 200 of robotic arm R, as described herein, Paragraph [0064]); inserting the scalpel into the guide tube and performing a plunge incision to form an incision (an incision is made in the skin 51 of a patient with the scalpel, which creates a surgical pathway for implantation of components of spinal implant system 10, Paragraph [0064]); attaching a tracking array to a dilator (dilator includes a mating element, for example, a bushing 42, bushing 42 is configured to connect a navigation component 280 with surgical instrument 12, Figures 3-4, Paragraph [0052]), the dilator sized and shaped to be removably insertable into a lumen of a tissue protector (tissue protector 150 receives the dilator 30, Figure 1), the dilator comprising an elongate body extending from a proximal end for passing through tissue and a distal end (dilator 30 extends between a proximal end 32 and a distal end 34. Dilator defines a longitudinal axis X1, Paragraph [0050], Figure 4, end 34 includes a tapered configuration to facilitate spacing of tissue, Paragraph [0051]); inserting the dilator into the lumen of the tissue protector to form an assembled dilator-tissue protector assembly (A cannula 150 is inserted into end effector 200 and is inserted into the surgical pathway, Paragraph [0064]), the tissue protector comprising an elongate body having a proximal end, a distal end, and the lumen extending therethrough from the proximal end to the distal end (cannula 150, Figure 18-19, Paragraph [0064]), the tissue protector insertable through the guide tube of the robot (surgical instrument 12 is configured for use with a guide member, for example, an end effector 200 of robotic arm R to determine axial trajectory of a surgical pathway and/or facilitate positioning of one or more instruments, implants, and/or components of spinal implant system 10 in alignment with the axial trajectory of a surgical pathway, Paragraph [0078], Figure 21, cannula is insertable into the guide tube 200, Figure 21); and inserting the tissue protector of the assembled dilator-tissue protector assembly into the guide tube of the robot (surgical instrument 12 is configured for use with a guide member, for example, an end effector 200 of robotic arm R to determine axial trajectory of a surgical pathway and/or facilitate positioning of one or more instruments, implants, and/or components of spinal implant system 10 in alignment with the axial trajectory of a surgical pathway, Paragraph [0078], Figure 21, cannula is insertable into the guide tube 200, Figure 21).
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 13-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wall in view of Peters et al. (US 20170172589 A1) herein referred to as “Peters”.
Regarding claim 13, Wall discloses the spinal surgical system of claim 1, wherein the tracking array comprises a tracking array body removably attachable to the dilator (dilator 30 includes a mating element, for example, a bushing 42, bushing 42 is configured to connect a navigation component 280 with surgical instrument 12, Paragraph [0052], Figure 1), a plurality of arms extending outwardly from the tracking array body (Figure 1), each of the plurality of arms having a distal end (Figure 1).
However Wall does not explicitly disclose a plurality of trackers, the trackers attachable to the distal end of one of the plurality of arms.
Peters discloses a surgical instrument configured for connection to an image guide (Abstract) wherein the device comprises a tracking body array (navigation component 30 includes a tracking device having an emitter ray 50 that extends from and is connected to housing 32 via post 42, Paragraph [0035]) wherein the tracking body array comprises a plurality of trackers, the trackers attachable to the distal end of one of the plurality of arms (emitter array 50 includes four spaced apart arms having a substantially X-shape, emitter array 50 includes markers, such as, for example fiducials 52, fiducials 52 appear in an image produced by a surgical navigation system, Figure 5, Paragraph [0036]).
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 Wall to incorporate
the teachings of Peters by including a plurality of trackers, the trackers attachable to the distal end of one of the plurality of arm. The motivation to do so being to use the fiducials as a point of reference or a measure in the image produced by the surgical navigation system (Peters, Paragraph [0036]). US 20170172589 A1
Regarding claim 14, Wall in view of Peters discloses the spinal surgical system of claim 13.
However Wall does not explicitly disclose wherein the trackers are optically detectable by the robotic navigation system to facilitate navigation of the dilator during spinal surgery.
Peters discloses wherein the trackers are optically detectable by the robotic navigation system to facilitate navigation of the dilator during spinal surgery (emitter array 50 includes four spaced apart arms having a substantially X-shape, emitter array 50 includes markers, such as, for example fiducials 52, fiducials 52 appear in an image produced by a surgical navigation system, Figure 5, Paragraph [0036]).
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 Wall to incorporate the teachings of Peters by including wherein the trackers are optically detectable by the robotic navigation system to facilitate navigation of the dilator during spinal surgery. The motivation to do so being to use the fiducials as a point of reference or a measure in the image produced by the surgical navigation system (Peters, Paragraph [0036]).
Regarding claim 15, Wall in view of Peters discloses the spinal surgical system of claim 13.
Wall discloses wherein the tracking array body comprises an attachment mechanism to securely attach the tracking array body to the dilator (attachment mechanism comprises the post connected to the center of the tracking array body, Figure 1).
Regarding claim 16, Wall in view of Peters discloses the spinal surgical system of claim 15.
Wall further discloses wherein the tracking array body comprises a through-channel for selectively receiving a portion of the dilator (navigation component 280 includes a collar 282 having an inner surface 284 and an outer surface 286, surface 284 defines a passageway 288 wherein dilator 30 is received within the passageway, Paragraph [0053]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Crawford et al. (US 10624710 B2) discloses a surgical robot system, Sharifi-Mehr et al. (EP 3669801 A2) discloses a spinal marking system including a navigation tool, Finley et al. (US 11350995 B2) discloses a system for surgical navigation the one or more arrays secured with the spine of a patient, Finley et al. (US 20180092699 A1) discloses a system for surgical navigation wherein the one or more arrays are releasably secured with the spine, Crawford et al. (US 20180256259 A1) discloses a surgical implant comprising a planning computer positions an implant device relative to a bone of a patient, Cicchini et al. (US 20190388161 A1) discloses a surgical robot system, and Dace et al. (US 20200085500 A1) discloses a spinal implant system comprising robotic guidance.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Dana Stumpfoll whose telephone number is (703)756-4669. The examiner can normally be reached 9-5 pm (CT), M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Rodden can be reached at (303) 297-4276. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/D.S./Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
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