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 § 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, 25, 26, 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 an assembly for accessing a facet joint between a first vertebra and a second vertebra adjacent said first vertebra, said assembly comprising:
a facet access portion (facet access tool 100) comprising:
a proximal elongated body portion (handle 106) comprising a first central longitudinal axis, and
at least one distal blade portion (distal tip 102 includes blade 112) configured for insertion into said facet joint (Figs. 3A-3H and 10).
McCormack also discloses accessing a posterior portion of one of the first vertebra and the second vertebra (see Fig. 10) and the use of at least one instrument (decorticator 230; see Figs. 14A-14I).
Claim 22. McCormack discloses wherein the at least one instrument comprises one of a drill, a rasp and a decorticator (decorticator 230; see Figs. 14A-14I) (Figs. 3A-3H and 10).
Claim 25. McCormack discloses wherein the posterior portion consists of a portion of a lateral mass of said first vertebra or second vertebra (see Fig. 10) (Figs. 3A-3H and 10).
Claim 26. McCormack discloses wherein the facet joint is a cervical facet joint (para. 0007) (Figs. 3A-3H and 10).
McCormack fails to disclose a guide portion defining at least a first lumen, wherein said first lumen comprises a second central, longitudinal axis, and a second lumen, said second lumen comprising a third central longitudinal axis, wherein the portions of the guide portion defining the first and second lumen are coupled and the first lumen is in communication with the second lumen, wherein said first and second central longitudinal axes are distinct and parallel, wherein said second and third central longitudinal axes are distinct and parallel and wherein said first lumen of said guide portion provides access to a posterior portion of one of the first vertebra and the second vertebra, and further wherein the first lumen of the guide portion is configured to receive and guide at least one instrument to said posterior portion, wherein the facet access portion is in a fixed position relative to the guide portion (claim 21), wherein said at least one distal blade portion extends distally beyond a distal end of said first lumen (claim 23), and wherein at least one of the first and second lumens is configured to receive the elongated body portion of said facet access portion (claim 40).
However, McCormack teaches that, in use, it may be desirable to use the facet access portion (facet access tool 100) in conjunction and in parallel with an introducer tool (introducer 150) (Fig. 10).
Michelson teaches a guide portion (dual outer sleeve 1350) defining at least a first lumen (lumen in hollow cylinder 1352 that receives distractor 1320), wherein said first lumen comprises a second central, longitudinal axis, and a second lumen (lumen in hollow cylinder 1354 that receives distractor 1322), said second lumen comprising a third central longitudinal axis, wherein the portions of the guide portion defining the first and second lumen are coupled and the first lumen is in communication with the second lumen, wherein said second and third central longitudinal axes are distinct and parallel and wherein said first lumen of said guide portion provides access to a portion of one of a first vertebra and a second vertebra, and further wherein the first lumen of the guide portion is configured to receive and guide at least one instrument (distractor 1320) to said first vertebra or said second vertebra, wherein the first and second lumens are shaped complementary to the instruments (distractors 1320 and 1322) for a fitted, fixed relationship between the instruments and the respective lumens (see Fig. 38) (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 portion of McCormack and provide a guide portion defining at least a first lumen, wherein said first lumen comprises a second central, longitudinal axis, and a second lumen, said second lumen comprising a third central longitudinal axis, wherein the portions of the guide portion defining the first and second lumen are coupled and the first lumen is in communication with the second lumen, wherein said second and third central longitudinal axes are distinct and parallel and wherein said first lumen of said guide portion provides access to one of a first vertebra and a second vertebra, and further wherein the first lumen of the guide portion is configured to receive and guide at least one instrument to said first vertebra or said second vertebra (claim 21), wherein the first and second lumens are shaped complementary to the instruments/tools received therein for a fitted, fixed relationship between the instruments and the respective lumens, as suggested by Michelson, as such a guide portion 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, the facet access portion would be in a fixed position relative to the guide portion (claim 21) when inserted therein. Furthermore, it would have been obvious to insert the facet access portion of McCormack into the second lumen as such is one of a finite number of lumens in the guide portion and insert the facet access portion such that it extends distally beyond a distal end of the guide portion as the distal blade portion of the facet access portion would necessarily need to be exposed in order to be able to be used as shown in Fig. 10 of McCormack. In view of the aforementioned modifications, and because McCormack discloses posterior access of the facet joint, said first and second central longitudinal axes would be distinct and parallel (claim 21), said first lumen of said guide portion would provide access to the posterior portion of one of the first vertebra and the second vertebra (claim 21), said at least one distal blade portion would extend distally beyond a distal end of said first lumen (claim 23), and at least one of the first and second lumens is would be configured to receive the elongated body portion of said facet access portion (claim 40).
Response to Arguments
Applicant's arguments filed September 15, 2025 have been fully considered but they are not persuasive.
Applicant argues that the access tool of McCormack is not in a defined or fixed position relative to the introducer, much less with an introducer in the claimed configuration with two working lumens (see pg. 5). The Examiner notes that Applicant appears to be interpreting the rejection as modifying the introducer of McCormack to have two lumens. As stated in the rejection above, this is not occurring. Instead, an additional instrument is being provided, wherein that additional instrument is a guide portion as taught by Michelson.
Applicant argues that there is no reason to add an additional tool, such as a dual lumen guide tube (see pg. 5). The Examiner disagrees. As stated in the rejection above, McCormack teaches that, in use, it may be desirable to use the facet access portion (facet access tool 100) in conjunction and in parallel with an introducer tool (introducer 150) (Fig. 10). Furthermore, the rationale for providing an additional tool in the form of a guide portion as taught by Michelson, is that such a guide portion can ensure both tools (facet access tool 100 and introducer 150) are inserted along the proper trajectory while also protecting soft tissue from the distal ends of the tools during insertion. Such a guide portion effectively functions as a cannula to (a) protect soft tissue, (b) provide an insertion trajectory, and (c) in doing (a) and (b), allow for a more minimally invasive surgical approach. It is well-known in the art that a minimally invasive surgical approach, which would minimize the size of the incision and the size of the surgical opening, is advantageous in that healing time is reduced.
Applicant argues that Michelson teaches access to the disc space not the facet joint (see pgs. 5-6). The Examiner notes that Michelson was merely relied upon to teach the use of a guide portion, and not for access to a specific surgical site. Furthermore, the claims at issue are apparatus claims, not method claims, and thus a guide portion as taught by Michelson is capable of being used to provide access to a different spinal surgical site to that taught by Michelson.
Applicant also argues that McCormack already has an introducer and thus there is no need for an additional tool (see pg. 6). The Examiner disagrees. As stated in both the rejection and response above, the rationale for providing an additional tool in the form of a guide portion as taught by Michelson, is that such a guide portion can ensure both tools (facet access tool 100 and introducer 150) are inserted along the proper trajectory while also protecting soft tissue from the distal ends of the tools during insertion.
In response to Applicant's argument that the Examiner's conclusion of obviousness is based upon improper hindsight reasoning (see pg. 6), it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). In the instant case, it is well-known in the art that protecting soft tissue, providing a proper insertion trajectory, and allowing for a more minimally invasive surgical approach are all advantages to the use of a cannula in a surgical procedure. As stated by the Examiner, doing so minimizes the size of the incision and the size of the surgical opening, allowing for a reduced healing time.
Applicant also argues that McCormack teaches that the tip of the introducer is configured to provide a point of entry and to enable distraction, decortication, decompression, and fusion and thus there is no room for another tool (see pg. 6). The Examiner disagrees. McCormack does not require that the introducer act as a point of entry for other tools, but merely states that the introducer is configured such that it may act in such a manner if so desired. For example, McCormack states in the following paragraph that distraction can be accomplished via a number of methods (see para. 0090).
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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