DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 6/19/2026 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 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 8-9, 11, 14-15, 17-18 and 20 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Baynham et al (2007/0270968) in view of Michelson (7,118,579) in view of Michelson (2011/0004310) and further in view of Allain et al (2009/0105832). Evidenced by Allen (5,658,335).
Baynham et al teaches an expandable intervertebral system comprising:
an intervertebral implant defining a proximal end (depicted) and a distal end (depicted) spaced from the proximal end along a distal direction, the implant comprising:
upper and lower body portions 11, 13;
a wedge member 42 disposed between the upper and lower body portions with respect to the vertical direction;
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an actuator shaft 67 coupled to the wedge member, wherein rotation of the actuator shaft in a first direction of rotation causes the wedge member to translate distally, thereby urging the upper body portion away from the lower body portion along the vertical direction. See par. 0029-0030. The proximal end of the actuator shaft is configured to receive a deployment tool engagement member and is between first and second anti-torque apertures (depicted) at a proximal end of the intervertebral implant.
However, Baynham et al is silent regarding the exact configuration of the deployment tool for inserting and expanding the intervertebral implant. It is inherent that some type of deployment tool having a distal engagement member is used to engage the proximal end of the actuator shaft to rotate the actuator shaft (see figure 3).
Referring to at least figure 55, Michelson ‘579 teaches a deployment tool for inserting and expanding an expandable intervertebral implant 1100, the deployment tool comprising:
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a handle section (not shown, attached to 1206 via 1202; also see evidenced deployment tool of Allen below);
a rod 1302 that is supported so as to be rotatable relative to the handle section, the rod having a distal engagement member 1308 that extends straight and linearly in the distal direction and is configured to rotate and is configured to engage an actuator shaft of an intervertebral implant, such that rotation of the rod causes the actuator shaft to rotate, thereby expanding the implant from an unexpanded state to an expanded state; and
first and second anti-torque protrusions 1210 that extend straight and linearly in the distal direction are configured to be inserted in the distal direction into respective anti-torque apertures of the implant (see figure 60 of Michelson ‘579) so as to stabilize the implant as the rod is rotated to cause the actuator shaft to rotate,
wherein the distal engagement member is disposed between the first and second anti-torque protrusions (shown in figure 55) and are fully capable of engaging the proximal end of an actuator shaft.
It would have been obvious to one having ordinary skill in the art to have used a similar deployment tool as taught by Michelson ‘579 for inserting and expanding the expandable intervertebral implant of Baynham et al by modifying the distal engagement member and anti-torque protrusions to extend straight and linearly in a distal direction as necessary to match proximal end of the actuator shaft and the anti-torque apertures at the proximal end of the implant of Baynham et al for deploying, expanding and contracting the implant.
Further, the anti-torque apertures (depicted) of Baynham et al are not open to respective ones of the opposed sides along the horizontal direction.
Allain et al also teaches an intervertebral implant system which includes
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anti-torque aperures 24 open to respective ones of the opposed sides along the the horizontal direction; see par. 0024.
It would have been obvious to one having ordinary skill in the art to have increased the distance between the anti-torque apertures of Baynham et al such that they are slightly open with respective ones of the opposed sides along the the horizontal direction to increase rotational control of the implant relative to the horizontal direction.
Further, it is unclear if the intervertebral implant of Baynman et al has a wedge shape in the expanded state.
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Michelson ‘310 also teaches an expandable implant comprising upper and lower body portions 682, 684, a wedge member and an actuator shaft wherein at least the body portions are configured such that the intervertebral implant has a wedge shape in the expanded stated as shown. It would have been obvious to one have ordinary skill in the art to have configured the upper and lower body portions of Baynham et al as taught by Michelson ‘310 such that the implant of Baynman et al has a wedge shape in the expanded stated to correct spinal curvature such as lordosis.
The examiner further provides Allen as evidence:
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Allen teaches an intervertebral implant deployment tool comprising a straight rod 102 having a distal engagement member that extends straight and linearly in the distal direction and is configured to engage the proximal end of an actuator shaft 50. The tool further comprising a handle section 100 with first and second anti-torque protrusions (depicted) to grasp/engage the proximal end of the implant. It is known in the art that the tool distal engagement member and anti-torque protrusion both engage the proximal end of the implant. Allen teaches:
(10) A conventional, hollow insertion tool 100 is used to gasp a nut assembly 70 to insert the retracted spinal fixator 20 between the two vertebrae bodies 4. Following placement as in FIG. 1, a tool 102 having a terminus defining a hex configuration is inserted through the insertion tool 100 to engage in aperture 60 in the core member 50.
Claim 9, rotation direction controls upper and lower body portions towards or away from each other.
Claims 11 and 17, the rod axis is self-evident and is disposed between first and second protrusions as shown above. The first and second anti-protrusions of Baynhan et al are in a horizontal plane when connected.
Claim 14, sleeve 1202 extends out with respect to the handle section (also see 100 of Allen having a handle section). Rod 1302 is disposed within the sleeve.
Claim 15, sleeve 1202 extends out with from the handle section (also see 100 of Allen having a handle section). Rod 1302 is disposed within the sleeve.
Claim 18, as shown above first and second protrusions 1210 are coplanar with the distal engagement member.
Claim 20, the axes are self-evident.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRUCE EDWARD SNOW whose telephone number is (571)272-4759. The examiner can normally be reached 7:30 am - 5:00 pm Monday through Thursday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached on 5712729062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRUCE E SNOW/ Primary Examiner, Art Unit 3774
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