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 § 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 34 and 40 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.
Claim 34 recites the limitation "the threaded portion" in line 2. There is insufficient antecedent basis for this limitation in the claim.
With respect to claim 40 the claims “a threaded portion that engages a threaded portion of the sleeve…” and then claims “the threaded portion of the shaft engaging threads of the internally threaded cap.” It is unclear how the same threaded portion can engage both the sleeve and the cap in light of the specification and the figures. The specification and drawings show two distinct threaded portions (fig 18, 148 and 143) that are disconnected on opposite ends of the shaft. Claim 40 should distinguish between the two threaded portions.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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) 21-40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Elliot et al. (US Pub 2020/0121396) in view of Garcia et al. (US Pub 2020/0069376).
With respect to claim 21, Elliot discloses a surgical system (see figures 1-3 and 7 below) comprising: a sleeve(fig 1, 106) extending along a longitudinal axis (fig 2, L) between opposite proximal and distal ends, the sleeve defining a passageway (fig 1, 12 and 14); a first image guide (fig 1, 16) coupled to the proximal end, the first image guide being disposed relative to a sensor (abstract) to communicate a signal representative of a position of the first image guide; a shaft (fig 1, 12 and 14)disposed in the passageway. With respect to claim 22, Elliot discloses wherein the distal end of the shaft extends through the distal end of the sleeve (fig 1). With respect to claim 23, Elliot discloses wherein the shaft is rotatable (paragraph 47, rote 12) relative to the sleeve about the longitudinal axis. With respect to claim 24, Elliot discloses wherein the shaft is translatable relative to the sleeve along the longitudinal axis (paragraph 50). With respect to claim 33, Elliot discloses wherein the shaft includes a proximal end (see fig 2 and 3 below) opposite the distal end of the shaft, the proximal end of the shaft defining a threaded portion (paragraph 77, threaded engagement between the navigation sleeve and shaft) that engages a threaded portion of the sleeve to couple the shaft to the sleeve. With respect to claim 34, Elliot discloses further comprising an internally threaded cap (paragraph 51, threaded inner surface of a receiver), wherein the threaded portion (fig 1, 60) of the shaft further engages threads of the internally threaded cap (paragraph 51). With respect to claim 37, Elliot discloses wherein the distal end of the sleeve includes a base and spaced apart arms (see fig 7 below) extending from the base, the arms defining an implant cavity (space between arms can hold a rod) therebetween configured for disposal of a spinal rod. With respect to claim 38, Elliot discloses wherein the implant cavity has an inverted U-shape (see fig 7 below).
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With respect to claim 21, Elliot discloses the claimed invention but does not disclose a second image guide disposed relative to the sensor to communicate a signal representative of a position of the second image guide, a distal end of the shaft engaging the second image guide to couple the second image guide to the shaft.
Garcia discloses a second image guide (fig 8, 220) disposed relative to the sensor (fig 1, 165) to communicate a signal representative of a position of the second image guide (paragraph 35), a distal end of a shaft (fig 8, 206) engaging the second image guide to couple the second image guide to the shaft to allow the instrument to be located in the surgical field tying it to a coordinate system (paragraph 4). With respect to claim 25, Garcia discloses wherein the distal end of the shaft engages the second image guide to couple the second image guide to the shaft such that the second image guide is fixed relative to the shaft (paragraph 62, seated in the housing). With respect to claim 36, of Gracia discloses further comprising a frame (fig 8, 222 of Garcia that is coupled to the second image guide, the frame being configured for engagement with vertebrae (paragraph 30).
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It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Elliot to include a second image guide disposed relative to the sensor to communicate a signal representative of a position of the second image guide, a distal end of the shaft engaging the second image guide to couple the second image guide to the shaft in view of Garcia in order to allow the instrument to be located in the surgical field tying it to a coordinate system. With respect to claim 26, Elliot in view of Gracia discloses wherein the distal end of the shaft includes a projection (the tip of the shaft of Elliot shows a tapered projected tip as shown in figure 3 above) that is disposed in a recess (Garcia discloses the image guide having a recess (fig 8, 236) to recess a tip of a tool) of the second image guide to couple the second image guide to the shaft. With respect to claim 27, Elliot in view of Gracia discloses wherein the projection is tapered (both Garcia and Elliot shows the projected tip to have a taper). With respect to claim 28, Elliot in view of Gracia discloses wherein the projection is cone shaped (both Garcia and Elliot shows the projected tip to have a taper). With respect to claim 29, Elliot in view of Garcia discloses wherein the recess is cone shaped (fig 9, 326 of Garcia) such that the projection is matingly engaged with the recess. With respect to claim 28, Elliot in view of Gracia discloses wherein the distal end of the shaft is threaded (fig 3 of Elliot shows the distal end is threaded) with the second image guide to couple the second image guide to the shaft. With respect to claim 30, Elliot in view of Gracia discloses wherein the projection is ball shaped (For claim 30, the Shaft includes just the adaptor 12 end 42 in Elliot is disclosed as can having a circular shape and Garcia shows a ball shaped protrusion). With respect to claim 31, Elliot in view of Gracia discloses wherein the recess is socket shaped such that the projection is matingly engaged with the recess (fig 8). With respect to claim 35, Elliot in view of Gracia discloses wherein the shaft is coaxial with the sleeve and an emitter array of the second image guide (Elliot shows the sleeve and shaft coaxially arranged while Garcia shows the shaft coaxial to the second guide).
With respect to claim 39, Elliot discloses a surgical system (see figures 1-3 and 7 below) comprising: a sleeve(fig 1, 106) extending along a longitudinal axis (fig 2, L) between opposite proximal and distal ends, the sleeve defining a passageway (fig 1, 12 and 14); a first image guide (fig 1, 16) coupled to the proximal end, the first image guide being disposed relative to a sensor (abstract) to communicate a signal representative of a position of the first image guide; a shaft (fig 1, 12 and 14)disposed in the passageway; wherein the shaft includes a proximal end (see fig 3 above) opposite the distal end of the shaft, the proximal end of the shaft defining a threaded portion that engages a threaded portion of the sleeve to couple the shaft to the sleeve (paragraph 77, threaded engagement between the navigation sleeve and shaft).
With respect to claim 39, Elliot does not disclose a second image guide disposed relative to the sensor to communicate a signal representative of a position of the second image guide, a distal end of the shaft engaging the second image guide to couple the second image guide to the shaft; and a frame that is coupled to the second image guide, the frame being configured for engagement with vertebrae, wherein the distal end of the shaft includes a tapered projection that is disposed in a recess of the second image guide to couple the second image guide to the shaft.
Garcia discloses a second image guide (fig 8, 220) disposed relative to the sensor (fig 1, 165) to communicate a signal representative of a position of the second image guide (paragraph 35), a distal end of a shaft (fig 8, 206) engaging the second image guide to couple the second image guide to the shaft wherein the distal end of the shaft (Fig 8, 200) includes a tapered projection (Fig 8, 208) that is disposed in a recess of the second image guide to couple the second image guide to the shaft and a frame (fig 8, 222 of Garcia that is coupled to the second image guide, the frame being configured for engagement with vertebrae (paragraph 30) to allow the instrument to be located in the surgical field tying it to a coordinate system (paragraph 4).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Elliot to include a second image guide disposed relative to the sensor to communicate a signal representative of a position of the second image guide, a distal end of the shaft engaging the second image guide to couple the second image guide to the shaft; and a frame that is coupled to the second image guide, the frame being configured for engagement with vertebrae, wherein the distal end of the shaft includes a tapered projection that is disposed in a recess of the second image guide to couple the second image guide to the shaft in view of Garcia in order to allow the instrument to be located in the surgical field tying it to a coordinate system.
With respect to claim 40, Elliot discloses a surgical system (see figures 1-3 and 7 below) comprising: a sleeve(fig 1, 106) extending along a longitudinal axis (fig 2, L) between opposite proximal and distal ends, the sleeve defining a passageway (fig 1, 12 and 14); a first image guide (fig 1, 16) coupled to the proximal end, the first image guide being disposed relative to a sensor (abstract) to communicate a signal representative of a position of the first image guide; a shaft (fig 1, 12 and 14) disposed in the passageway wherein the shaft includes a proximal end (see fig 2 and 3 below) opposite the distal end of the shaft, the proximal end of the shaft defining a threaded portion (paragraph 77, threaded engagement between the navigation sleeve and shaft) that engages a threaded portion of the sleeve to couple the shaft to the sleeve wherein the system comprising an internally threaded cap (paragraph 51, threaded inner surface of a receiver), wherein the threaded portion (fig 1, 60) of the shaft further engages threads of the internally threaded cap (paragraph 51), and wherein the shaft is coaxial with the sleeve (fig 1).
With respect to claim 40, Elliot discloses the claimed invention except for and a second image guide disposed relative to the sensor to communicate a signal representative of a position of the second image guide, a distal end of the shaft engaging the second image guide to couple the second image guide to the shaft, wherein the distal end of the shaft includes a tapered projection that is disposed in a recess of the second image guide to couple the second image guide to the shaft,
Garcia discloses a second image guide (fig 8, 220) disposed relative to the sensor (fig 1, 165) to communicate a signal representative of a position of the second image guide (paragraph 35), a distal end of a shaft (fig 8, 206) engaging the second image guide to couple the second image guide to the shaft wherein the distal end of the shaft (Fig 8, 200) includes a tapered projection (Fig 8, 208) that is disposed in a recess of the second image guide to couple the second image guide to the shaft and a frame (fig 8, 222 of Garcia that is coupled to the second image guide, the frame being configured for engagement with vertebrae (paragraph 30) to allow the instrument to be located in the surgical field tying it to a coordinate system (paragraph 4).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Elliot to include a second image guide disposed relative to the sensor to communicate a signal representative of a position of the second image guide, a distal end of the shaft engaging the second image guide to couple the second image guide to the shaft; and a frame that is coupled to the second image guide, the frame being configured for engagement with vertebrae, wherein the distal end of the shaft includes a tapered projection that is disposed in a recess of the second image guide to couple the second image guide to the shaft in view of Garcia in order to allow the instrument to be located in the surgical field tying it to a coordinate system. With respect to claim 40, Elliot in view of Gracia discloses wherein the shaft is coaxial with the sleeve and an emitter array of the second image guide (Elliot shows the sleeve and shaft coaxially arranged while Garcia shows the shaft coaxial to the second guide).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 20040167391 A1 discloses a system with image guides
US 20070016009 A1 discloses a system with image guides
US 20150105833 A1 discloses a system with image guides and instruments
US 9179984 B2 discloses a system with image guides with frames
US 20200330160 A1 discloses a system with image guides and instruments
US 10285715 B2 discloses a system with image guides and instruments
US 6226548 B1 discloses a system with image guides and instruments and a frame
US 20180296283 A1 discloses a system with image guides and instruments
US 11389252 B2 discloses a system with image guides and instruments and frame
US 9848922 B2 discloses a system with image guides and instruments
US 8939995 B2 discloses a system with image guides and instruments and frame
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/S.J.C/Examiner, Art Unit 3773 /EDUARDO C ROBERT/Supervisory Patent Examiner, Art Unit 3773