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 .
Election/Restrictions
Claims 35-41 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 5/28/2024.
Applicant’s election without traverse of Group I, drawn to a tissue cutter, in the reply filed on 5/28/2024 is acknowledged.
Response to Arguments
The previous objection of claim 1 due to minor informalities has been withdrawn in light of applicant’s amendments made 12/31/2025.
Applicant's arguments filed 12/31/2025 have been fully considered but they are not persuasive. Applicant argues the cutting element of Ahrens (US 2020/0229829) is positioned within a recess at the distal end of the shaft, but Ahrens fails to teach or disclose a spacing element sized and configured to substantially fill an initial discectomy channel formed by the tissue cutter within the intervertebral disc adjacent the at least one vertebral body, the spacing element comprising a housing having an internal cavity positioned between opposing first and second sides as claimed. The examiner respectfully disagrees as the recess formed at the distal end of the shaft of Ahrens forms the claimed cavity. For example, the walls of the brackets 60, 61 form opposing first and second sides, in between which is an internal cavity that the pinion 20 of the cutting arm 10 is positioned within (Figs. 2-3). Accordingly, the cutting element (10) is positioned at least partially within the internal cavity of the spacing element as claimed.
Applicant’s arguments that Carter does not cure the defect of Ahrens are moot in light of Ahrens disclosing the amended claim language as discussed above. Applicant’s arguments that one of ordinary skill in the art would not be motivated to combine features of Carter with features of Ahrens since any such combination would likely increase the cross sectional area of the tool in violation of the teachings of Ahrens are not found persuasive because the modification of Ahrens in view of Carter does not increase the size of the support 50 and instead provides the additional benefit of limiting the distance the tissue cutter is inserted into vertebrae, preventing over insertion into disc space.
Based on the above remarks, the application is not found in condition for allowance at this time.
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.
Claim(s) 24-27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ahrens et al. (US 2020/0229829 A1) in view of Carter et al. (US 2016/0213415 A1).
Regarding claim 24, Ahrens discloses a tissue cutter (surgical cutting instrument 1; Figs. 1-5), comprising: a spacing element (support 50) sized and configured to substantially fill an initial discectomy channel (channel formed by inserting the distal end of the device into a spinal disc; [0079]) formed by the tissue cutter within the intervertebral disc adjacent at least one vertebral body (as the cutting arm 10 and the support 50 together have a profile which is no greater in cross-sectional area than that of the surgical instrument body 2; [0071]), the spacing element (50) comprising a housing (body of 50) having an internal cavity (opening between brackets 60, 61; Figs. 2-3) positioned between opposing first and second sides (60 61); and a cutting element (cutting arm 10) comprising at least one cutting flange (right side 41 and left side 42 of blade 40 of cutting arm 10), each cutting flange having at least one cutting edge (cutting edges on both upper periphery 44 and lower periphery 45) for expanding the initial discectomy channel (by pivoting rotation of cutting arm 10; Figs. 3-4); wherein the cutting element (10) is positioned at least partially within the internal cavity (as at least pinion 20 of the cutting arm 10 is positioned in the opening between brackets 60, 61; Figs. 2-3) of the spacing element (50; Figs. 1-4).
Ahrens fails to disclose an elongate body having a longitudinal axis, and comprising at least one depth stop configured to abut at least one vertebral body adjacent an intervertebral disc within an intervertebral disc space, wherein the cutting element is configured to translate within the intervertebral disc space relative to the at least one depth stop and the elongated body along the longitudinal axis.
However, Carter teaches a tissue cutter (Fig. 2), comprising: an elongated body (guide cannula 30) having a longitudinal axis, and comprising at least one depth stop (distal end face of 30 which surrounds surgical tool 10; therefore, limits access of surgical tool therethrough; Fig. 2; it is further noted that applicant’s own depth stop may be configured as a second cannula; [0090]) configured to abut at least one vertebral body adjacent an intervertebral disc within an intervertebral disc space (Fig. 2), a cutting element (tissue scraping elements 15s; Fig. 7c), wherein the cutting element (15s) is configured to translate relative to the at least one depth stop (distal end face of 30) and the elongated body (30) along the longitudinal axis (as the tubular support member 40 can slidably receive and releasably hold the guide cannula 30 and tool barrel 10b, which carries tissue scraping elements 15s; [0143]).
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 tissue cutter of Ahrens to include the elongated body and depth stop taught by Carter in order to contact adjacent vertebrae to prevent over insertion of the tissue cutter into the disc space.
Regarding claim 25, Ahrens modified discloses the invention as claimed above and Ahrens further discloses wherein the at least one cutting edge (cutting edges on both upper periphery 44 and lower periphery 45) is extendable past the opposing first and second sides (60, 61; Figs. 2-4).
Regarding claim 26, Ahrens modified discloses the invention as claimed above and Ahrens further discloses wherein the cutting element (10) comprises at least one cutting flange (41 or 42) positioned along a lateral edge of the elongated body (as 41 and 42 are on the sides of the elongate body 3).
Regarding claim 27, Ahrens modified discloses the invention as claimed above and Ahrens further discloses wherein the at least one cutting flange (41, 42) is configured to pivot in a sweeping arc motion such that the at least one cutting edge (44, 45) advances through tissue within the intervertebral disc space to expand the initial discectomy channel (Figs. 3-4).
Claim(s) 28-29 and 31-32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ahrens et al. (US 2020/0229829 A1) in view of Carter et al. (US 2016/0213415 A1), as applied to claim 24 above, and further in view of Osman et al. (US 2015/0282817 A1).
Regarding claims 28-29 and 31-32, modified Ahrens fails to disclose a second cutting element positioned at least partially within the internal cavity of the spacing element comprising at least one cutting flange having at least one cutting edge for expanding the initial discectomy channel, the at least one cutting flange of the second cutting element is configured to pivot in a sweeping arc motion past the opposing first and second sides such that at least one cutting edge of the second cutting element advances through tissue within the intervertebral disc space to expand the initial discectomy channel, wherein the cutting element and the second cutting element are positioned on opposing sides of the spacing element, and wherein the cutting element and the second cutting element are configured to operate simultaneously.
However, Ahrens discloses the cutting element (10) positioned at least partially within the internal cavity (as 20 is between 60, 61) of the spacing element (Figs. 2-3), the cutting element comprising at least one cutting flange (41, 42), each cutting flange of the cutting element having at least one cutting edge (44, 45) for expanding the initial discectomy channel (Figs. 3-4), the at least one cutting flange of the cutting element is configured to pivot in a sweeping arc motion past the opposing first and second sides (60, 61; Figs. 2-4) such that at least one cutting edge of the cutting element advances through tissue within the intervertebral disc space to expand the initial discectomy channel (Figs. 3-4; [0078]) and Osman teaches first and second cutting elements (cutting elements 332) on opposing sides of a spacing element (head portion 330; Fig. 3C) that are actuated simultaneously (via actuation means 310; [0052]) with a gear system ([0053]) in order to remove disc material between vertebral bodies ([0052]). Thus, Ahrens discloses a drive element to allow for pivoting of the geared body of the cutting element in a sweeping arc motion and Osman teaches opposing blades that operate on a geared drive to expand.
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 tissue cutter of modified Ahrens to include a duplicate cutting element on the opposing side of the spacing element in light of the teachings of Osman in order to increase the range of cutting simultaneously. The court has held that a mere duplication of parts has no patentable significance unless a new and unexpected result is produced. In the instant case, an unexpected result is not produced, rather an increased range of cutting is provided. Further, the duplication of the cutting element of modified Ahrens on the opposing side of the spacing element would result in the cutting element having at least one cutting flange and at least one cutting edge for further expanding the initial discectomy channel by pivoting the cutting elements simultaneously.
Allowable Subject Matter
Claims 1, 3-5, 7-8 and 33-34 are allowed.
The following is a statement of reasons for the indication of allowable subject matter: Applicant’s arguments filed 8/01/2025 with respect to claim 1 over Ahrens in view of Bourque and Josse have been found persuasive, as discussed in the response to arguments on pages 2-3 of the Non-Final Rejection mailed 10/01/2025.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 SARAH A LONG whose telephone number is (571)270-3865. The examiner can normally be reached Monday-Friday 9am-5pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached on (571)272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SARAH A LONG/Primary Examiner, Art Unit 3771