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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on December 4, 2025 has been entered.
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.
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.
Claims 21, 23, 24, 26, 27, 29-31, 33-38, and 40 are rejected under 35 U.S.C. 103 as being unpatentable over McCormack et al. (US 2009/0177205 A1) in view of Michelson (US 6,080,155 A).
Claim 21. McCormack discloses a guide device for accessing a cervical spine, the device comprising: a facet access body (facet access tool 100) comprising: a distal portion (distal end 102) comprising an end portion (distal end 102) configured for insertion in a cervical facet joint (see para. 0007), and a proximal shaft portion (handle 106) extending from the distal portion; wherein a height of the proximal shaft portion of the facet access body is different than a height of at least a part of the distal portion of the facet access body (Figs. 3A-3H and 10).
Claim 23. McCormack discloses wherein the accessing the cervical spine is via a posterior approach (see Fig. 10) (Figs. 3A-3H and 10).
Claim 26. McCormack discloses the use of a drill guide, a drill and/or a decorticator (decorticator 230; see Figs. 14A-14I) (Figs. 3A-3H and 10). McCormack also discloses wherein the decorticator has a similar cross-sectional shape to the facet access body (see Figs. 3E and 14A).
Claim 27. McCormack discloses a guide device for accessing a portion of a facet joint, the device comprising: a facet access tool (facet access tool 100) comprising a distal end portion (distal end 102) configured for insertion at the facet joint (Figs. 3A-3H and 10). McCormack also discloses that the guide device is for accessing the facet joint of the cervical spine (see para. 0007).
Claim 29. McCormack discloses wherein the facet access tool further comprises a proximal portion (handle 106) and the height of the proximal portion is different than a height of at least a part of the distal portion (Figs. 3A-3H and 10).
Claim 30. McCormack discloses wherein the accessing a portion of the facet joint is via a posterior approach (see Fig. 10) (Figs. 3A-3H and 10).
Claim 33. McCormack discloses the use of a drill guide, a drill and/or a decorticator (decorticator 230; see Figs. 14A-14I) (Figs. 3A-3H and 10). McCormack also discloses wherein the decorticator has a similar cross-sectional shape to the facet access tool (see Figs. 3E and 14A).
Claim 34. McCormack discloses a system for accessing a facet joint, the system comprising: a facet access tool (facet access tool 100) comprising a distal portion (distal end 102) configured for insertion at or near the facet joint; wherein the facet access tool comprises a distal end portion (distal end 102) (Figs. 3A-3H and 10). McCormack also discloses that the guide device is for accessing the facet joint of the cervical spine (see para. 0007).
Claim 35. McCormack discloses wherein the facet joint is a cervical facet joint (see para. 0007) (Figs. 3A-3H and 10).
Claim 36. McCormack discloses wherein the facet access tool further comprises a proximal portion (handle 106) and the height of the proximal portion is different than a height of at least a part of the distal portion (Figs. 3A-3H and 10).
Claim 37. McCormack discloses wherein the accessing the facet joint is via a posterior approach (see Fig. 10) (Figs. 3A-3H and 10).
Claim 40. McCormack discloses the use of a drill guide, a drill and/or a decorticator (decorticator 230; see Figs. 14A-14I) (Figs. 3A-3H and 10). McCormack also discloses wherein the decorticator has a similar cross-sectional shape to the facet access tool (see Figs. 3E and 14A).
McCormack fails to disclose a guide tube configured for insertion in the cervical facet joint, the guide tube comprising at least two working lumens coupled together and having parallel and distinct central longitudinal axes, wherein each lumen of the at least two lumens of the guide tube has a cross-section and the cross-section of one lumen overlaps the cross section of a second lumen along at least a portion of a length of the one lumen, wherein the one lumen is configured to provide access to the facet joint and the second lumen is configured to provide access to bone directly above or below the facet joint, wherein the facet access body is received by the guide tube (claim 21), wherein the guide tube is slidable relative to the facet access body (claim 24), wherein the guide tube is configured to receive a drill guide, drill and/or decorticator (claim 26), a guide tube configured for insertion in the facet joint of the cervical spine, the guide tube comprising at least two working lumens coupled together and having parallel and distinct central longitudinal axes, wherein each lumen of the at least two lumens of the guide tube has a cross-section and the cross-section of one lumen overlaps the cross section of a second lumen along at least a portion of a length of the one lumen, wherein the one lumen is configured to provide access to the facet joint and the second lumen is configured to provide access to bone directly above or below the facet joint, wherein the guide tube is configured to receive the facet access tool via at least one of the at least two lumens, (claim 27), wherein the guide tube is slidable relative to the facet access tool (claim 31), wherein the guide tube is configured to receive a drill guide, drill and/or decorticator (claim 33), a guide tube configured for insertion in the facet joint of the cervical spine, the guide tube comprising a first working lumen coupled to a second working lumen, the first and second lumens having parallel and distinct central longitudinal axes, wherein the first lumen has a cross-section and the second lumen has a cross-section and the cross sections overlap along at least a portion of a length of one of the first and second lumen, wherein the one lumen is configured to provide access to the facet joint and the second lumen is configured to provide access to bone directly above or below the facet joint, wherein the distal end portion extends from the first or second lumen of the guide tube (claim 34), wherein the guide tube is slidable relative to the facet access tool (claim 38), and wherein the guide tube is configured to receive a drill guide, drill and/or decorticator (claim 40).
However, McCormack teaches that, in use, it may be desirable to use the facet access body/tool (facet access tool 100) in conjunction and in parallel with an introducer tool (introducer 150) (Fig. 10). McCormack further teaches that the facet access body/tool is configured to access the facet joint (facet joint 16) and the introducer tool is configured to access bone (the vertebral body of vertebra 12) directly above the facet joint (Fig. 10).
Michelson teaches a guide tube (dual outer sleeve 1350) comprising at least two working lumens (one lumen is in hollow cylinder 1352 and receives distractor 1320; the other lumen is in hollow cylinder 1354 and receives distractor 1322) coupled together and having parallel and distinct central longitudinal axes, wherein each lumen of the at least two lumens of the guide tube has a cross-section (note that the cross-section of each lumen is circular as shown in Fig. 37) and the cross-section of one lumen overlaps the cross section of a second lumen along at least a portion of a length of the one lumen (the cross-sections overlap near the middle of dual outer sleeve 1350 at a location near prongs 1364b and 1364e), wherein each lumen is configured to slidably receive a tool (distractor 1320 or distractor 1322) such that the tools can be used in conjunction and parallel to each other (Figs. 36-41).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the facet access body/tool and introducer tool of McCormack and provide a guide tube comprising at least two working lumens coupled together and having parallel and distinct central longitudinal axes, wherein each lumen of the at least two lumens of the guide tube has a cross-section and the cross-section of one lumen overlaps the cross section of a second lumen along at least a portion of a length of the one lumen (claims 21, 27, and 34), as suggested by Michelson, wherein the guide tube is configured to receive the facet access body/tool and introducer tool in conjunction and parallel to each other, as suggested by Michelson, as such a guide tube can ensure both tools are inserted along the proper trajectory while also protecting soft tissue from the distal ends of the tools during insertion. In view of such a modification, and because McCormack discloses using the facet access body/tool and introducer tool in the facet joint of the cervical spine (see para. 0007), it is obvious that the guide tube would be configured for insertion in the cervical facet joint of the cervical spine (claims 21, 27, and 34). Furthermore, in view of such a modification, and because McCormack teaches that the facet access body/tool is configured to access the facet joint and the introducer tool is configured to access bone directly above the facet joint, the one lumen would be configured to provide access to the facet joint and the second lumen would be configured to provide access to bone directly above or below the facet joint (claims 21, 27, and 34). Also, in view of such a modification, the facet access body would be received by the guide tube (claim 21), the guide tube would be slidable relative to the facet access body/tool (claims 24, 31, and 38), the guide tube would be configured to receive a drill guide, drill and/or decorticator (claims 26, 33, and 40), the guide tube would be configured to receive the facet access tool via at least one of the at least two lumens (claim 27), and the distal end portion would extend from the first or second lumen of the guide tube (claim 34).
Response to Arguments
Applicant argues that the access tool of McCormack is not received by the introducer (see pg. 5), that there is no reason to add a dual lumen guide tube (see pg. 5), and that the tool of McCormack is for access to the disc space, not the facet joint (see pg. 5 and pg. 6). The Examiner disagrees and notes that these arguments were addressed in the Final Rejection mailed on September 4, 2025 (see pgs. 8-9).
Applicant also argues that the present device has a vertical orientation compared to the horizontal orientation of Michelson’s device (see pgs. 5-6). The Examiner disagrees. First of all, the orientation is based on the intended use and Michelson’s device could be held in such a manner that one lumen provides access to a facet joint and a second lumen provides access to bone directly above or below the facet joint. Furthermore, such argument is disregarding that the teachings of Michelson are being combined with McCormack. As stated in the rejection above, McCormack teaches at the facet access body/tool (facet access tool 100) is configured to access the facet joint (facet joint 16) and the introducer tool (introducer 150) is configured to access bone (the vertebral body of vertebra 12) directly above the facet joint (Fig. 10). Thus, combining the teachings of Michelson with regard to the structure of the guide tube with the aforementioned use taught by McCormack would result in the one lumen being configured to provide access to the facet joint and the second lumen being configured to provide access to bone directly above or below the facet joint as recited in the claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JULIANNA N HARVEY whose telephone number is (571)270-3815. The examiner can normally be reached Mon.-Fri. 8:00am-5:00pm EST.
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/JULIANNA N HARVEY/Primary Examiner, Art Unit 3773