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
Applicant’s argument regarding the restriction between claims 1-18 and claims 19-20 is persuasive and the restriction requirement is withdrawn.
Claim Objections
Claims 3-6 are objected to because of the following informalities:
Claim 3 recites “anterior side distal articulating arm and posterior side distal articulating arm” in lines 1-2. Please correct the grammatical issue: e.g., - “an” anterior side distal articulating arm and “a” posterior side distal articulating arm. Appropriate correction is required.
Claim 4 recites “anterior side proximal articulating arm and posterior side proximal articulating arm” in lines 1-2. Please correct the grammatical issue: e.g., - “an” anterior side proximal articulating arm and “a” posterior side proximal articulating arm. Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-8, 14-17, 19 and 20 is/are rejected under 35 U.S.C. 102a2 as being anticipated by Ries (US 20220395379).
With respect to claim 1, Ries discloses an expandable intervertebral spine implant (1, see para. 44-46 and also fig. 1-3a below) having an anterior side, a posterior side, a distal end and a proximal end (see fig. 1 below), the implant comprising: (a) a center rod (4) having a center rod length comprising a proximal threaded portion (4.2) having a proximal threading direction and a distal threaded portion (4.1) having a distal threading direction opposite the proximal threading direction (see fig. 1-3a below, para. 46); (b) a proximal sled (5a) coupled to the proximal threaded portion and a distal sled (5) coupled to the distal threaded portion (see fig. 1-3a below); (c) at least one pair of anterior side plates comprising an anterior side top plate (2.1) and an anterior side bottom plate (2.3), wherein said anterior side top plate is reversibly connected to said anterior side bottom plate and wherein each anterior side plate is discrete from, and oppose, each other (see fig. 1-3a below); and (d) at least one pair of posterior side plates comprising a posterior side top plate (2.2) and a posterior side bottom plate (2.4), wherein said posterior side top plate is reversibly connected to said posterior side bottom plate and wherein each posterior side plate is discrete from, and oppose, each other (see fig. 1-3a below); wherein when the center rod is rotated in a first rotation direction, the distal sled and the proximal sled move further apart relative to one another along the length of the center rod (see fig. 3, 3a below and also para. 73-74) and wherein when the center rod is rotated in a second rotation direction opposite the first rotation direction the distal sled and the proximal sled move closer along the length of center rod (see fig. 2, 2a below and para. 73-74); and wherein the expandable intervertebral spine implant is configured so that: (i) when the distal sled and the proximal sled are positioned closest to each other within a central portion of the center rod, the implant is in a compact position (see fig. 2, 2a below); (ii) when the distal sled and the proximal sled move farther apart along a first length in each direction from the center portion of the center rod, the anterior side plates and the posterior side plates move farther apart from one another and from the center rod thereby expanding the implant in a first expansion direction (e.g., lateral direction, see fig. 6 and also para. 73-74); and (iii) when the distal sled and the proximal sled move farther apart from the center portion along a second length of the center rod, the anterior side top plate and the anterior side bottom plate move apart from one another thereby expanding the implant on the anterior side in a second expansion direction (e.g., vertical direction, see fig. 7 and also para. 73-74).
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As for claim 2, Ries further discloses the implant of claim 1, wherein the second expansion direction is approximately perpendicular to the first expansion direction (see fig. 6 and 7).
As for claim 3, Ries further discloses the implant of claim 1, wherein the distal sled is connected to anterior side distal articulating arm (5.2.2) and posterior side distal articulating arm (see fig. 2 above).
As for claim 4, Ries further discloses the implant of claim 3, wherein the proximal sled is connected to anterior side proximal articulating arm and posterior side proximal articulating arm (see fig. 2 above).
As for claim 5, Ries further discloses the implant of claim 4, wherein the anterior side distal articulating arm and the anterior side proximal articulating arm are configured to move the anterior side plates (see fig. 2 above).
As for claim 6, Ries further discloses the implant of claim 4, wherein the posterior side distal articulating arm and the posterior side proximal articulating arm are configured to move the posterior side plates (see fig. 2 above).
As for claim 7, Ries further discloses the implant of claim 1, wherein the anterior side top plate and the anterior side bottom plate each have a U-shaped side profile (see fig. 1 above, and note curved shape).
As for claim 8, Ries further discloses the implant of claim 7, wherein the U-shape of the anterior side top plate is configured to reversibly slide into the U-shape of the anterior side bottom plate forming an open space therebetween (e.g., to receive 3, see fig. 6).
As for claim 14, Ries further discloses the expandable variable angulation intervertebral spine implant of claim 1, wherein said implant has dimensions and configuration adapted to allow the implant to be inserted into an intervertebral disc space via Kambin's Triangle (see para. 72 and note that this device is capable of performing this function if one so desires).
As for claim 15, Ries further discloses the implant of claim 1, further comprising a frame (e.g., access sleeve, see para. 72-73 and note incorporated by reference US 20160045334) that couples to and contains the center rod, the distal sled and the proximal sled (see para. 73).
As for claim 16, Ries further discloses the implant of claim 15, wherein frame comprises a frame distal end having an insertion component (3a1) configured to facilitate insertion of the implant and a frame proximal end including a socket or opening configured for receipt of an insert tool to rotate the center rod (see fig. 6l below of incorporated by reference US 20160045534).
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As for claim 17, Ries further discloses the implant of claim 16, wherein the frame proximal end comprises an opening configured to allow an insert tool to secure and pivot the implant within an intervertebral disc space and also to contact and rotate the proximal end of the center rod (see fig. 6l above of incorporated by reference US 20160045534 and note that the access sleeve is capable of receiving an insert tool that performs those functions).
As for claim 19, Ries discloses a method for stabilizing a spinal unit of a spinal column of a subject (see para. 72-73, also note the reference to US 20160045334 which has been incorporated by reference), the spinal unit comprising a superior vertebral bone, an inferior vertebral bone, an intervertebral disc space disposed there between (see para. 72-73), the method comprising: (a) forming a skin incision in the subject (see para. 3 of US 20160045334, incorporated by reference); (b) extending a tissue corridor from the skin incision to the intervertebral disc space through a natural opening formed by a superior endplate of an inferior vertebral bone, superior articular process of an inferior vertebral bone and a path of a spinal nerve and a first vertical axis that extends, in a cephalad to caudad direction, along a vertical plane of a spinal column (see para. 3, 62, 88 of US 20160045334, incorporated by reference); (c) approaching the intervertebral disc space with the implant of claim 1 using an insert tool (see para. 72-73), wherein the central rod is rotated and positioned so that the distal sled and the proximal sled are close to the central portion of the center rod thus reducing the dimensions of the implant for insertion (see fig. 2 and para. 73); (d) seating the implant within the intervertebral disc space using the insert tool (see para. 72-73); (e) rotating the center rod using the insert tool to move the distal sled and the proximal sled farther apart along a first length from a center portion of the center rod and thus moving the anterior side plates and the posterior side plates farther apart from one another and from the center rod thereby expanding the implant in a first expansion direction (see fig. 2-3 and 6 and para. 73-74); (f) further rotating the center rod using the insert tool to move the distal sled and the proximal sled farther apart from a center portion along a second length of the center rod and thus move the anterior side top plate and the anterior side bottom plate apart from one another thereby expanding the implant on the anterior side in a second expansion direction (see fig. 6 and 7 and para. 73-75); and (g) removing the insert tool (see para. 97 of US 20160045334, incorporated by reference).
As for claim 20, Ries further teaches the method of claim 19, further comprising, after the step of seating the implant in the intervertebral disc space, pivoting the implant within the intervertebral disc space (see para. 97 of US 20160045334, incorporated by reference and also para. 73-75 and note that the movement of the anterior and posterior plates are pivoted relative to each other during expansion).
Claim Rejections - 35 USC § 103
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.
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ries (US 20220395379), as applied to claim 1 above, in view of Huang (US 20210137695).
As for claim 18, Ries further teaches wherein the proximal threaded portion of center rod comprises a proximal end (e.g., at 4.4, see fig. 2a above) and a distal end (e.g., closest to 4.3), wherein the proximal end comprises a recess configured for receipt of an insert tool to rotate the center rod (see para. 46).
Ries does not teach the distal end comprises a prong configuration to connect to the distal threaded portion.
Huang, also drawn to expandable implants with a center rod actuator, teaches a center rod (40, 21) wherein proximal threaded portion (40) of center rod comprises proximal end (42) a distal end that comprises a prong configuration (e.g., see fig. 15 below) to connect to the distal threaded portion (21) in order to provide an alternate equivalent configuration of a center rod that performs the same function of actuation of the implant between compact and expanded configurations (see para. 40).
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Ries wherein the distal end comprises a prong configuration to connect to the distal threaded portion, in view of Huang, as a matter of engineering design choice, in order to provide an alternate equivalent configuration of a center rod that performs the same function of actuation of the implant between compact and expanded configurations.
Reasons for Allowance
The following is a statement of reasons for the indication of allowable subject matter:
The claims in the instant application have not been rejected using prior art because no references, or reasonable combination thereof, could be found which disclose, or suggest, the claimed combination of limitations recited in independent claim 1 (and dependent claim 7). In particular, none of the cited references teach or suggest wherein the U-shape of the anterior side top plate comprises a flat horizontal central portion, a stepped-up portion on each side of the flat horizontal central portion and a ramping portion on each end of the stepped-up portion opposite the flat horizontal central portion, as required by claim 9.
The claims in the instant application have not been rejected using prior art because no references, or reasonable combination thereof, could be found which disclose, or suggest, the claimed combination of limitations recited in independent claim 1 (and dependent claim 7). In particular, none of the cited references teach or suggest wherein the U-shape of the anterior side bottom plate comprises a flat horizontal central portion, a stepped-up portion on each side of the flat horizontal central portion and an angled ramping portion on each end of the stepped-up portion opposite the flat horizontal central portion, as required by claims 10-13.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Allowable Subject Matter
Claims 9-13 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: US 20160256291; US 20190117409.
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/TARA ROSE E CARTER/ Examiner, Art Unit 3773
/EDUARDO C ROBERT/ Supervisory Patent Examiner, Art Unit 3773