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 .
EXAMINER’S COMMENT
There does not appear to be any overlapping subject matter requiring a Double Patenting over US Patents 12059181, 12274477 and 11839414 at this time.
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 20 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Singh (US 20200323571).
With respect to claim 20, Singh discloses an apparatus (see fig. 13c below) comprising: a cannulated tubular body (906) configured to be inserted into a surgical site (see fig. 13a); and an elongated mechanical support (918) configured to (i) be axially aligned with the cannulated tubular body when in a collapsed state (see para. 115), and (ii) bend outward in a radial direction when in an expanded state (see fig. 13c below, para. 115), wherein the cannulated tubular body includes a slot (917), and wherein the elongated mechanical support is configured to protrude through the slot when in the expanded state (see fig. 13c below and para. 115).
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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.
Claims 1, 2, 4 and 6-8 is/are rejected under 35 U.S.C. 103 as being obvious over Singh (US 20200323571) in view of Nijenbanning (US 20080262497).
With respect to claim 1, Singh teaches a device (see fig. 13c below) comprising: a cannulated tubular body (906) having a first end (e.g., at 912) configured to be inserted into a spinal surgical site and a second end (e.g., at 910) (see para. 106); and an expansion component (e.g., 908/916) coupled to the cannulated tubular body comprising: a plurality of elongated mechanical supports (e.g., 918) (see para. 106-108) configured to (i) be axially aligned with the cannulated tubular body when in a collapsed state (e.g., see para. 106-108, 115, note that until 918 reaches 917, axial alignment is maintained), and (ii) bend outward in a radial direction when in an expanded state (see fig. 13c below and para. 106-109, 115); and a plug (e.g., 920) positioned within the cannulated tubular body configured to move in an axial direction and to contact and apply a force to the mechanical supports such that movement of the adjustment element plug toward the first end of the cannulated tubular body shifts the mechanical supports from the collapsed state to the expanded state (see fig. 13c below and para. 115), wherein the cannulated tubular body includes a plurality of slots (e.g., 917), and wherein each of the elongated mechanical supports is configured to protrude through one of the plurality of slots when in the expanded state (see fig. 13c below).
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Singh teaches stabilization of a femur (see fig. 13a) and does not appear to teach the device for a spinal stabilization procedure.
Nijenbanning, also drawn to devices with expandable mechanical supports (see fig. 4-9), further teaches such devices for a variety of stabilization procedures including spinal (see fig. 1 and 3 below) in order to provide minimally invasive stabilization between bony elements as is well known in the art (see para. 12 and 14).
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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 Singh wherein the device is for a spinal stabilization procedure, in view of Nijenbanning, in order to provide minimally invasive stabilization between bony elements as is well known in the art.
As for claim 2, Singh, as modified by Nijenbanning, further teaches the device of claim 1, wherein each of the elongated mechanical supports are formed of flexible rods configured to undergo a change in shape when in the expanded state (see para. 108).
As for claim 4, Singh, as modified by Nijenbanning, further teaches the device of claim 2, wherein each of the elongated mechanical supports is formed of an elastic material and is configured to bend throughout its length to shift to the expanded state (see para. 108).
As for claim 6, Singh, as modified by Nijenbanning, further teaches the device of claim 1, wherein the each of the elongated mechanical supports is configured to not protrude through the plurality of slots when in the collapsed state (see para. 115).
As for claim 7, Singh, as modified by Nijenbanning, further teaches the device of claim 1, wherein the plug is configured to contact an end of each of the elongated mechanical supports (see para. 115, fig. 13c above and note that 920 appears to be integral with 908/916/918).
As for claim 8, Singh, as modified by Nijenbanning, further teaches the device of claim 1, wherein each of the elongated mechanical supports is disconnected from the cannulated tubular body (e.g., before insertion into 906 or upon exit from 917).
Claims 9, 11 and 21 is/are rejected under 35 U.S.C. 103 as being obvious over Singh (US 20200323571) in view of Nijenbanning (US 20080262497), as applied to claim 1 above, in view of Levy (US 20110319946).
As for claim 9, Singh, as modified by Nijenbanning, teaches use of a mechanical stop (e.g., 915) located on 906 to prevent the plug from backing out (see para. 106) but does not teach wherein the cannulated tubular body includes an internal threaded portion at the second end which is axially adjacent to the plug when the mechanical supports are in the collapsed state.
Levy, also drawn to devices with expandable mechanical supports (see fig. 15a), wherein the cannulated tubular body (18) includes an internal threaded portion (27) at a second end which is axially adjacent to a plug (24) when mechanical supports (22) are in the collapsed state (see fig. 1a, 1c) in order to provide an alternate equivalent mechanical fastening mechanism that will perform the same function of communication/coupling with the plug while preventing the plug from backing out while deploying the mechanical supports (see para. 27, 99).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the mechanical stop of Singh, as modified by Nijenbanning, to instead include wherein the cannulated tubular body includes an internal threaded portion at the second end which is axially adjacent to the plug when the mechanical supports are in the collapsed state, in view of Levy, in order to provide an alternate equivalent mechanical fastening mechanism that will perform the same function of communication/coupling with the plug while preventing the plug from backing out while deploying the mechanical supports.
As for claim 11, Singh, as modified by Nijenbanning, teaches use of a mechanical stop (e.g., 915) located on 906 to prevent the plug from backing out (see para. 106) and the use of a force applied to the plug to actuate the mechanical supports (see para. 115) but does not teach a bolt with threads configured to be rotated to apply a downward force on the plug.
Levy, also drawn to devices with expandable mechanical supports (22), teaches a bolt (24) with threads configured to be rotated to apply a downward force on a plug (e.g., 15) in order to provide an alternate equivalent mechanical actuating mechanism that will perform the same function of communication/coupling with the plug to deploy the mechanical supports (see para. 27, 99).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the mechanical actuator of Singh, as modified by Nijenbanning, to include a bolt with threads configured to be rotated to apply a downward force on the plug, in view of Levy, in order to provide an alternate equivalent mechanical actuating mechanism that will perform the same function of communication/coupling with the plug to deploy the mechanical supports.
As for claim 21, Singh, as modified by Nijenbanning, does not teach wherein the cannulated tubular body includes a plurality of fenestrations configured to allow delivery of bone cement through the cannulated tubular body.
Levy, also drawn to devices with expandable mechanical supports (22), teaches wherein the cannulated tubular body includes a plurality of fenestrations (e.g., via lattice or other pattern of holes, see para. 84) configured to allow delivery of bone cement through the cannulated tubular body (see para. 84) in order to provide known structure that will permit bony ingrowth through the device (see para. 84).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Singh, as modified by Nijenbanning, wherein the cannulated tubular body includes a plurality of fenestrations configured to allow delivery of bone cement through the cannulated tubular body, in view of Levy, in order to provide known structure that will permit bony ingrowth through the device.
Claim 10 is/are rejected under 35 U.S.C. 103 as being obvious over Singh (US 20200323571) in view of Nijenbanning (US 20080262497), as applied to claim 1 above, in view of Reimels (US 10172656).
Singh, as modified by Nijenbanning, does not appear to teach wherein each of the plurality of elongated mechanical supports are formed of a material comprising nitinol.
Reimels, also drawn to expandable surgical devices (screws), teaches wherein the mechanical supports are formed of a material comprising nitinol (see abstract and col. 7 lines 4-10) in order to provide a known biocompatible material that allows for a preset expansion trajectory using the addition of the material properties that will permit the desired radial expansion (see col. 1 lines 5-7).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Singh, as modified by Nijenbanning, wherein each of the plurality of elongated mechanical supports are formed of a material comprising nitinol, in view of Reimels, in order to provide a known biocompatible material that allows for a preset expansion trajectory using the addition of the material properties that will permit the desired radial expansion.
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. In particular, none of the cited references teach or suggest the device including a plurality of elongated mechanical supports configured to be axially aligned with the cannulated tubular body when in a collapsed state and wherein the cannulated tubular body includes a plurality of slots, wherein each of the elongated mechanical supports is configured to protrude through one of the plurality of slots when in the expanded state; wherein each of the elongated mechanical supports has a uniform width along its length, as required by claim 3.
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. In particular, none of the cited references teach or suggest the device including wherein the mechanical supports are configured to contact and expand the mesh in the expanded state, as required by claim 12.
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 13. In particular, none of the cited references teach or suggest the device including a plurality of elongated mechanical supports configured to be axially aligned with the cannulated tubular body when in a collapsed state, wherein each of the plurality of elongated mechanical supports has a uniform width along its length; wherein the cannulated tubular body includes a plurality of slots, wherein each of the elongated mechanical supports is configured to protrude through one of the plurality of slots when in the expanded state, as required by claims 13-15, 17-19 and 22.
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 13-15, 17-19 and 22 are allowed.
Claims 3 and 12 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.
Response to Arguments
The Double Patenting rejection is withdrawn in view of the amendment entered on 4/6/2026.
Previously pending claims 5 and 16 were indicated as containing allowable subject matter and incorporated into claims 1 and 13, respectively. Upon further search, Singh has been used as the primary prior art to reject claims 1, 2, 4, 6-11, 20 and 21 as stated in the US 103(a) rejection above. Please see the Reasons for Allowance regarding claims 3 and 12 as well as the Reasons for Allowance regarding claims 13 (and dependent claims 14, 15, 17-19 and 22).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: US 20080262497 (fig. 4-9); US 20210177609 (fig. 5c); US 9452003 (fig. 18).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Tara Carter whose telephone number is (571) 272-3402. The examiner can normally be reached on M-F 7am-3pm.
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If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Eduardo Robert, at (571) 272-4719. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TARA ROSE E CARTER/ Examiner, Art Unit 3773
/EDUARDO C ROBERT/ Supervisory Patent Examiner, Art Unit 3773
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