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 .
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, 7, 11, 13-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Palmatier et al. (U.S. Publication No. 2018/0085232)
Palmatier et al. discloses a method for inserting a spinal implant into a vertebral space, the method comprising: connecting a spinal implant (150) to an inserter (12) comprising a shaft (14) having a navigation component (70) positioned thereon, the shaft defining a central axis (A1) of the inserter; selectively moving the navigation component from a first fixed position on the shaft to a second fixed position on the shaft by rotating the navigation component about a circumference of the shaft (paragraph 48); receiving, by a sensor array (202) of a navigation system, spatial data from the navigation component corresponding to a position of the inserter and/or implant relative to the vertebral space (Figure 7); displaying the spatial data on a monitor (222); manipulating the inserter to deliver the spinal implant into the vertebral space; and disengaging the inserter from the spinal implant ((Figure 8, 9, paragraph 86).
Regarding claim 7, the navigation component includes a first emitter array 82 in communication with the sensor array (202) of the navigation system; the sensor array is in communication with a processor (220); and wherein the method further includes sending a signal, including the spatial data, from the first emitter array to the sensor array of the navigation system (paragraph 51 and 77).
Regarding claim 11, the spatial data from the navigation component corresponds to a trajectory of the inserter and/or implant relative to the vertebral space (paragraph 77, “real time tracking” is correlated to the trajectory).
Regarding claim 13, the method further comprising receiving, by the sensor array of the navigation system, spatial data from a second emitter array (216) corresponding to a position and/or orientation of the navigation component relative to the inserter (paragraph 74).
Regarding claim 14, connecting the inserter to the spinal implant includes engaging one or more prongs (64) on an end of the inserter with one or more mating surfaces on an end of the spinal implant (Figure 6).
Regarding claim 15, the shaft extends between a first end and a second end along the central axis, the second end including a first mating surface disposed on a side thereof and having a protrusion (106); the spinal implant includes a body extending between a first end and a second end (Figure 6), the second end including a second mating surface disposed on a side thereof and having a groove (Figure 1, 6, it can be seen that in figure 1 and 6 that there is a groove); and the method further comprises engaging the protrusion of the first mating surface with the groove of the second mating surface (Figure 1, 6).
Regarding claim 16, the protrusion is configured to engage the groove when the protrusion and the groove are in a first orientation relative to one another and the protrusion is prevented from engaging the groove when the protrusion and the groove are in a second orientation relative to one another. It can be seen in figure 1 and 2 that the protrusion can fit in the groove in the shown orientation but would not fit if the implant were rotated about its long axis 90 degrees.
Regarding claim 17, the method further comprising manipulating an inner sleeve (34) disposed along the central axis of the shaft to draw the spinal implant in tight fixation with the second end.
Regarding claim 18, the implant includes a body disposed between a first end and a second end and having a first width; and the implant includes a tip disposed at the second end (Figure 6).
Regarding claim 19, the tip is configured to prevent an incorrect insertion orientation of the implant within an intervertebral disc space (Figure 6, the tip is asymmetric and thus provides an visual indication of a desired orientation)
Regarding claim 20, the tip extends at an angle relative to the body and has a second width greater than the first width. In this case, the body can be considered the circular region where element 64 attaches (Figure 6) and the tip is the rest of the implant, thus having an angle and a width greater than the body.
Allowable Subject Matter
Claims 2-6, 8-10, 12 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: The prior art alone or in combination fails to disclose the method of inserting a spinal implant where the implant is connected to an inserter having a navigation component that is rotatable about a shaft axis from a first fixed position to a second fixed position, receiving spatial data by a sensor array of a position of the inserter and or implant, displaying the spatial data on a monitor and delivering the implant to a vertebral space. The navigation element being rotated in order to align with the sensor array via its rotational connection with the shaft. Further features of the connection are also not disclosed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW YANG whose telephone number is (571)272-3472. The examiner can normally be reached 9:00 - 9:00 M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Truong can be reached at 571-272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANDREW YANG/Primary Examiner, Art Unit 3775
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