DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
According to the Amendment filed on 11/24/25, Claims 24, 26, 38 are amended, and claims 24, 26-39 are pending.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 24, 26-39 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Arcenio et al. (US 20090240335) in view of Gharib et al. (US 20050075578 A1) and further in view of To (US 20110098531 A1).
Arcenio et al discloses a method for performing orthopedic surgery, comprising: introducing a guide member (an access cannula) 40, fig. 16-18 along a trajectory toward a Kambin’s triangle para. 108; and inserting an intervertebral implant fig. 16-18; and through the access cannula 40 into an intervertebral space through the Kambin’s triangle para. 108; and expanding the intervertebral implant fig. 16 and 20.
Arcenio et al fails to teach determining that a nerve has been stimulated with an electrical current during the introducing step when the guide approaches or comes into contact with the nerve, and avoiding the nerve while insertion of the implant, wherein the guide member comprises a guide wire, further comprising driving at least one dilator tube over the guide wire, further comprising inserting at least one additional dilator tube over the dilator tube, further comprising inserting an access cannula over an outermost one of the at least one additional dilator tube, further comprising removing the at least one dilator tube and the guide wire prior to the inserting step, wherein the determining step comprises visually observing a visual indication that the guide member is approaching the nerve or observing movement of a leg of a patient, further comprising attaching a pedicle screw to a pedicle of a vertebra.
Gharib teaches determining that a nerve has been stimulated with an electrical current during the introducing step when the guide approaches or comes into contact with the nerve (para. 89, 91) and avoiding the nerve while insertion of the implant (para. 57, 59, 96, 99), wherein the guide member comprises a guide wire 46, fig. 16, further comprising driving at least one dilator tube 48, fig. 16 over the guide wire, further comprising inserting at least one additional dilator tube 48, fig. 17 over the dilator tube, further comprising inserting an access cannula 50, fig. 18 over an outermost one of the at least one additional dilator tube, further comprising removing the at least one dilator tube and the guide wire prior to the inserting step fig. 19, wherein the determining step comprises visually observing a visual indication that the guide member is approaching the nerve (para. 94, 96) or observing movement of a leg of a patient figs 20-28, further comprising attaching a pedicle screw to a pedicle of a vertebra (para. 100).
It would have been obvious to a person of ordinary skill in the art at the time of the invention was made to modify the method of Arcenio with the steps of stimulating the nerve with an electrical current during the introducing step when the guide approaches or comes into contact with the nerve, and avoiding the nerve while the insertion of the implant in view of Gharib in order to successfully create the operative corridor without impinging or otherwise compromising the nerves (para. 57).
Also It would have been obvious to a person of ordinary skill in the art at the time of the invention was made to modify the guide member of Arcenio with a guide wire, at least one dilator tube over the guide wire, inserting at least one additional dilator tube over the dilator tube, further comprising inserting an access cannula over an outermost one of the at least one additional dilator tube in view of Gharib in order to effectively creating an operative corridor to a surgical target site (such as K-wires, sequentially dilating cannula systems, distractor systems, and/or retractor systems) (para. 14) for retracting or otherwise protecting a nerve root before, during and/or after surgery (such as a nerve root retractor) (para. 52).
Arcenio in view of Gharib fail to teach performing a foraminoplasty so as to enlarge the Kambin's triangle before inserting an intervertebral implant.
To teaches “ a hooded burr or other bone removal instrument configured to protect or resist nerve injury may be used to shave or otherwise remove bone to enlarge the foramen.” (para. 162)
It would have been obvious to a person of ordinary skill in the art at the time of the invention was made to modify the method of Arcenio in view of Gharib with the step of performing a foraminoplasty so as to enlarge the Kambin's triangle before inserting an intervertebral implant further in view of To in order to protect or resist nerve injury.
Response to Arguments
Applicant’s arguments, with respect to the rejection(s) of claim(s) 24, 26-39 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of To.
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 SAMEH RAAFAT BOLES whose telephone number is (571)270-5537. The examiner can normally be reached 9-5 pm.
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/SAMEH R BOLES/Primary Examiner, Art Unit 3775