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 .
Specification
The specification amendment filed 11/26/25 has been entered.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “threaded fastener” and the “bias fastener” recited in Claims 3 & 4 and 17 & 18 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 12 is objected to because of the following informalities: In Line 4, the limitation “the fixation members” should be replaced with the limitation --the at least one fixation member--. Appropriate correction is required.
Claim 15 is objected to because of the following informalities and should be amended as follows in order to avoid positively reciting the human body: “wherein is configured to contact [[and]] the first vertebra or second vertebra such that [[prevents]] movement of the spacer body in the posterior direction is prevented.” Appropriate correction is required.
Claim 22 is objected to because of the following informalities: In Line 2, the word “couped” should be replaced with the word --coupled--. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 13 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 13 recites “wherein removing the spacer body further comprises applying a force to the spacer body in the anterior direction.” which is previously recited in Claim 9 from which Claim 13 depends.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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) 1-6, 8, 14-19 & 21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kirwan (US PG Pub. No. 2013/0110242).
Regarding Claim 1, Kirwan et al. discloses an anti-retropulsion lumbar interbody device (20, Figs. 1-8, Paragraphs [0034-0049]) comprising: a spacer body (22, Figs. 1-2) positionable between a first vertebra (26) and a second vertebra (28)(See Fig. 21 for example of similar embodiment, Paragraph [0034]); at least one fixation member (24, Figs. 3-5) connected to the spacer body (Figs. 6-7, Paragraph [0044]), the at least one fixation member movable between a retracted position (Fig. 5, when 24 is not yet fully inserted into 22) and a deployed position (Fig. 8, when 24 is fully inserted into 22), wherein in the deployed position at least a portion of the at least one fixation member (distal ends 78 of upper blade 66 & lower blade 68, Figs. 3 & 6-8) is extendable from the spacer body to contact the first or second vertebra when the spacer body is positioned between the first and second vertebra (Figs. 6-8 & 21); and wherein when the spacer body is moved in an anterior direction from the deployed position by a force in the anterior direction (such as via removal through the neck during a cervical procedure, “It should be appreciated that this allows the device 20 to be smaller, such as for use in cervical spine procedures for example.” “In some circumstances, the surgeon may desire to remove or reposition the device 20.”, Paragraphs [0040, 0052]), the at least one fixation member is self-retractable (Paragraphs [0035-0036, 0046-0047]), wherein the at least one fixation member is configured to self-retract by contact between the at least one fixation member and the first vertebra or the second vertebra (the anchor 24 is deflectable/deformable/resilient in that it may be repeatedly deformed and return to its original shape prior to its elastic limit being exceeded, Paragraph [0046]), thereby allowing the spacer body to be removed from between the first and second vertebra (“While the embodiments herein discusses the spinal procedures with respect to an anterior insertion approach, the claimed invention may also be used in other spinal procedures, such as but not limited to posterior insertion and lateral insertion for example.”, Paragraphs [0035-0036, 0040, 0052]) (upon engaging 20 anteriorly with a tool 56 at end 32 and pulling it anteriorly, such as through the front of the neck in the cervical spine area, the upper and lower blades 66 & 68 of 24 would deform and self-retract by contacting the upper and lower vertebrae during removal from the disc space).
Regarding Claim 2, Kirwan et al. discloses a fixation member releasing mechanism (90/90, Fig. 4, Paragraph [0044]; OR 106 of 56, Figs. 9-11, Paragraph [0050]) located on a posterior side of the spacer body (96, Fig. 7; OR through openings 52 & 54, Fig. 1), wherein activation of the fixation member releasing mechanism deploys the at least one fixation member to the deployed position (“To couple the anchor 24 and the cage 22, the surface 92 engages the sidewalls of opening 62, and the latching surface 94 engages a cage surface 96 (FIG. 6) when the anchor 24 is moved to the deployed or second position.”; OR “Once the cage 22 is positioned, the pusher rod 106 is actuated to linearly slide the anchor 24 from the opening 110 and deployed towards the second position.”, Paragraph [0051]).
Regarding Claim 3, Kirwan et al. discloses wherein the fixation member releasing mechanism (106) is a threaded fastener (“The pusher rod 106 may have a threaded end sized to couple with the threaded opening 70 of the anchor 24.”, Paragraph [0050]).
Regarding Claim 4, Kirwan et al. discloses wherein the fixation member releasing mechanism (90/90) is a bias fastener (each head portion 90 is deformable and biases to extend past cage surface 98 until the latching surface 94 engages 96 to fully secure 24 to 22, Paragraphs [0044, 0047]).
Regarding Claim 5, Kirwan et al. discloses wherein at least an outer surface of the at least one fixation member is configured to be in contact with at least one of the first or second vertebra (“The distal end 74 may include an edge 78 that facilitates the insertion of the blades 66, 68 into the vertebrae.”, Paragraph [0043]), See Fig. 21 for example of similar embodiment, Paragraph [0034]).
Regarding Claim 6, Kirwan et al. discloses wherein the at least one fixation member has an exteriorly concave shape (outer surfaces of blades 66 & 68 are concave as seen in Figs. 3, 5 & 8).
Regarding Claim 8, Kirwan et al. discloses wherein the at least one fixation member further comprises: a first fixation member (upper blade 66 of 24, Figs. 3-7, Paragraph [0037]) extendable outwards from a top surface (36, Fig. 8) of the spacer body; and a second fixation member (lower blade 68 of 24, Figs. 3-7, Paragraph [0037]) extendable outwards from a bottom surface (38, Fig. 8) of the spacer body, wherein the first and second fixation members self-retract when the spacer body is moved in the anterior direction (as stated above, upon engaging 20 anteriorly with a tool 56 at end 32 and pulling it anteriorly, such as through the front of the neck in the cervical spine area, the upper and lower blades 66 & 68 of 24 would deform and self-retract by contacting the upper and lower vertebrae during removal from the disc space).
Regarding Claim 14, Kirwan et al. discloses a system for spacing vertebrae (Figs. 1-11 & 21) comprising: a spacer body (20, Figs. 1-8, Paragraphs [0034-0049]) configured to be located between a first vertebra (26) and a second vertebra (28)(See Fig. 21 for example of similar embodiment, Paragraph [0034]), wherein the spacer body is capable of being positioned surgically from a posterior of a patient (“While the embodiments herein discusses the spinal procedures with respect to an anterior insertion approach, the claimed invention may also be used in other spinal procedures, such as but not limited to posterior insertion and lateral insertion for example.”, Paragraph [0035]); and at least one fixation member (24, Figs. 3-5) comprising an elongated structure (Fig. 3) connected to the spacer body (Figs. 5-8) and positioned in a deployed position (Figs. 6-8), wherein when in the deployed position, at least a portion of the at least one fixation member (distal ends 78 of upper blade 66 & lower blade 68, Figs. 3 & 6-8) is extended from the spacer body and is configured to be in contact with the first vertebra or second vertebra (Figs. 6-8 & 21), and wherein movement of the spacer body in an anterior direction from the deployed position (such as via removal through the neck during a cervical procedure, “It should be appreciated that this allows the device 20 to be smaller, such as for use in cervical spine procedures for example.” “In some circumstances, the surgeon may desire to remove or reposition the device 20.”, Paragraphs [0040, 0052]) causes the at least one fixation member to self-retract (the anchor 24 is deflectable/deformable/resilient in that it may be repeatedly deformed and return to its original shape prior to its elastic limit being exceeded, Paragraphs [0035-0036, 0046-0047]), wherein: the at least one fixation member is configured to self-retract by contact between the at least one fixation member and the first vertebra of the second vertebra (the anchor 24 is deflectable/deformable/resilient in that it may be repeatedly deformed and return to its original shape prior to its elastic limit being exceeded, Paragraph [0046]), thereby allowing the spacer body to be removed from between the first vertebra and second vertebra (“While the embodiments herein discusses the spinal procedures with respect to an anterior insertion approach, the claimed invention may also be used in other spinal procedures, such as but not limited to posterior insertion and lateral insertion for example.”, Paragraphs [0035-0036, 0040, 0052]) (upon engaging 20 anteriorly with a tool 56 at end 32 and pulling it anteriorly, such as through the front of the neck in the cervical spine area, the upper and lower blades 66 & 68 of 24 would deform and self-retract by contacting the upper and lower vertebrae during removal from the disc space).
Regarding Claim 15, Kirwan et al. discloses wherein contact between the at least one fixation member and the first vertebra or second vertebra prevents movement of the spacer body in the posterior direction (Paragraphs [0046-0047]).
Regarding Claim 16, Kirwan et al. discloses a fixation member releasing mechanism (90/90, Fig. 4, Paragraph [0044]; OR 106 of 56, Figs. 9-11, Paragraph [0050]) located on a posterior side of the spacer body (96, Fig. 7; OR through openings 52 & 54, Fig. 1), wherein activation of the fixation member releasing mechanism deploys the at least one fixation member to the deployed position (“To couple the anchor 24 and the cage 22, the surface 92 engages the sidewalls of opening 62, and the latching surface 94 engages a cage surface 96 (FIG. 6) when the anchor 24 is moved to the deployed or second position.”; OR “Once the cage 22 is positioned, the pusher rod 106 is actuated to linearly slide the anchor 24 from the opening 110 and deployed towards the second position.”, Paragraph [0051]).
Regarding Claim 17, Kirwan et al. discloses wherein the fixation member releasing mechanism (106) is a threaded fastener (“The pusher rod 106 may have a threaded end sized to couple with the threaded opening 70 of the anchor 24.”, Paragraph [0050]).
Regarding Claim 18, Kirwan et al. discloses wherein the fixation member releasing mechanism (90/90) is a bias fastener (each head portion 90 is deformable and biases to extend past cage surface 98 until the latching surface 94 engages 96 to fully secure 24 to 22, Paragraphs [0044, 0047]).
Regarding Claim 19, Kirwan et al. discloses wherein the at least one fixation member has an exteriorly concave shape (outer surfaces of blades 66 & 68 are concave as seen in Figs. 3, 5 & 8).
Regarding Claim 21, Kirwan et al. discloses wherein the at least one fixation member substantially conforms to the shape of the spacer body (Figs. 3 & 5-7 Paragraph [0043]).
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) 9-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kirwan (US PG Pub. No. 2013/0110242) in view of Duggal et al. (US PG Pub No. 2009/0076616).
Regarding Claims 9-13, Kirwan et al. discloses a method for using an anti-retropulsion lumbar interbody device (20, Figs. 1-8, Paragraphs [0034-0049]), the method comprising: locating a spacer body (22, Figs. 1-2) between a first vertebra (26) and a second vertebra (28)(See Fig. 21 for example of similar embodiment, Paragraph [0034]); removing the spacer body from between the first vertebra and the second vertebra (“In some circumstances, the surgeon may desire to remove or reposition the device 20.”, Paragraph [0052]); and self-retracting (Paragraphs [0035-0036, 0046-0047]) at least one fixation member (24, Figs. 3-5) comprising an elongated structure (Fig. 3) (the anchor 24 is deflectable/deformable/resilient in that it may be repeatedly deformed and return to its original shape prior to its elastic limit being exceeded, Paragraph [0046]) (“the surgeon may reattach the tool 56 to the device 20 by coupling the rods 100 to the cage 22 and the pusher rod 106 to the anchor 24. With the tool 56 and the device 20 coupled, the surgeon may then actuate (e.g. pull) the pusher rod 106 away from the patients spine with sufficient force to cause the arms 84, 86 to deflect and disengage the latching surface 94 from the cage surface 96. Thus the insertion of device 20 is reversible without having to resort to any cutting or machining of material from the device 20 within the patient., Paragraph [0052]), wherein the at least one fixation member is configured to contact the first vertebra or the second vertebra (See Fig. 21 for example of similar embodiment); inserting the spacer body between the first vertebra and second vertebra from a posterior direction (“While the embodiments herein discusses the spinal procedures with respect to an anterior insertion approach, the claimed invention may also be used in other spinal procedures, such as but not limited to posterior insertion and lateral insertion for example.”, Paragraph [0035]); and deploying the at least one fixation member of the spacer body by moving at least a portion of the at least one fixation member outwards to contact the first vertebra or the second vertebra (Paragraph [0045], Figs. 5-8).
Kirwan et al. does not disclose removing the spacer body by moving the spacer body in an anterior direction from an anterior position via a force in the anterior direction and self-retracting the at least one fixation member when the spacer body is moved, wherein the self-retracting is induced as the at least one fixation member contacts the first vertebra or the second vertebra, wherein removing the spacer body further comprises: cutting anteriorly into a patient; applying a force in the anterior direction to the spacer body, whereby applying the force causes the at least one fixation member to self-retract by moving in a direction towards the spacer body; wherein self-retracting of the at least one fixation member further comprises contact between at least one of the first or second vertebra and an outside surface of the at least one fixation member. Kirwan et al. does disclose in Paragraph [0035] that “While the embodiments herein discusses the spinal procedures with respect to an anterior insertion approach, the claimed invention may also be used in other spinal procedures, such as but not limited to posterior insertion and lateral insertion for example.” And further discloses in Paragraph [0040] that “It should be appreciated that this allows the device 20 to be smaller, such as for use in cervical spine procedures for example.” And even further discloses in Paragraph [0052] that “In some circumstances, the surgeon may desire to remove or reposition the device 20.” One having ordinary skill in the art would recognize that it is well known and common to insert an intervertebral spacer posteriorly or anteriorly depending on the type of procedure and anatomy, and remove the intervertebral spacer posteriorly or anteriorly from an anterior position during revision surgeries in the spine, such as through or from the front of the neck during cervical spinal surgery.
Duggal et al. discloses systems and methods for vertebral disc replacement (Fig. 1) comprising an interbody device (100) including a spacer body (102/104) and upper and lower fixation members (130, 131) extending outwardly therefrom (Figs. 2-3, Paragraphs [0101-0106]) and configured to cut into the vertebrae during insertion (Paragraph [0107]) of the interbody device between two adjacent vertebrae (upper 2 and lower 4, Fig. 1). Duggal et al. further discloses in Paragraph [0157] that “Each implant described herein may be revised or removed in the same or a subsequent procedure. For implant revision or removal, the patient is again prepared in a neutral posture position, and the target disc level of the spine is exposed from an anterior approach. Optionally, the adjustable retainer 800 and pins, or a distractor, may be used to distract the vertebral bodies. FIG. 42 illustrates a remover tool 1150 gripping implant 100 prior to removal. FIG. 43 illustrates a distal end of remover tool 1150 gripping the implant 100, and FIG. 44 is an exploded view of the distal end of the remover tool 1150.”
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the method of Kirwan et al. with the steps of exposing a target disc level of the spine from an anterior approach, removing the spacer body from between the first and second vertebrae by applying a force in the anterior direction with the remover tool to move the spacer body anteriorly from an anterior position, thus self-retracting the deformable upper and lower blades of the fixation member during implant repositioning or removal as taught by Duggal et al. as a well-known and common step of accessing the interbody device for revising or replacement after implantation if need be based on a patients particular needs.
Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kirwan (US PG Pub. No. 2013/0110242) in view of Tanaka et al. (US PG Pub No. 2015/0202051).
Regarding Claim 22, Kirwan et al. discloses the claimed invention as stated above in Claim 2, except wherein the fixation member releasing mechanism is a removably coupled sleeve.
Tanaka et al. discloses a spinal fusion system comprising an interbody fusion cage and an implanter tool (Abstract), wherein the implanter tool comprises a distal cage engagement portion (26, Fig. 12), an elongated body portion (44), and a proximal handle portion (42) for manually gripping by a user, wherein the cage (12, Paragraph [0075]) comprises left and right tool apertures for corresponding engagement with left and right projections (54 & 56, Paragraph [0083]) of distal cage engagement portion of the implanter tool (18, Fig. 12), and a central tool hole for corresponding engagement with a threaded distal termination (72, Paragraphs [0086-0087]) of an elongate central pusher shaft (76, Fig. 13) which extends through a central tubular outer sleeve (64, Paragraph [0085]), and wherein the pusher shaft is moveable and rotatable via a T-handle (74, Fig. 12) extending through the proximal handle portion for controlling the threaded distal termination, such that that the implanter tool is configured to removably couple to the cage for insertion, repositioning, or removing the cage (Paragraph [0018]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the inserter tool used with the spacer of Kirwan et al. to add a central outer sleeve over the pusher rod which extends through a proximal handle portion and is controlled by a T-handle at the proximal end thereof as taught by Tanaka et al. in order to provide the inserter tool with a handle and actuation means for manually controlling the distal end of the inserter as needed by a user.
Response to Arguments
Applicant’s amendments, filed 11/26/25, have overcome the objections to Claims 1, 5, 7-10, 12, 14-20.
Applicant’s amendments, filed 11/26/25, have overcome the 101 rejections for Claims 5, 7, 14 & 20.
Applicant’s amendments, filed 11/26/25, have overcome the 112(b) rejection for Claim 10.
In regards to the Applicant’s arguments, filed 11/26/25, with respect to the drawing objection: The Applicant’s argument has been fully considered but the drawing objection has been upheld as seen in the office action above. The Applicant contends that one having ordinary skill in the art would recognize that the fixation member releasing mechanism 160 as shown in Fig. 5 is “a fastener structure which is threaded” and a bias fastener is one that has a spring element that can be biased”. The element 160 in Fig. 5 does not appear to be either a threaded fastener or a bias fastener, and on the contrary, it appears to show an aperture which receives the tool 162. Thus, the drawings remain objected to as failing to show claimed subject matter as stated above. Appropriate correction is required.
In regards to the Applicant’s arguments, filed 11/26/25, with respect to the 103 rejection of Claims 1-8 & 14-20 as being unpatentable over Reed et al. in view of Carlson et al.: The Applicant’s arguments have been fully considered but are moot in view of the new grounds of rejection based on the newly amended claims.
In regards to the Applicant’s arguments, filed 11/26/25, with respect to the 103 rejection of Claims 9-13 as being unpatentable over Reed et al. in view of Carlson et al. and Duggal: The Applicant’s arguments have been fully considered but are moot in view of the new grounds of rejection based on the newly amended claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
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 JESSICA WEISS whose telephone number is (571) 270-5597. The examiner can normally be reached Monday through Friday, 8:00 am to 4:00 pm EST. If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, KEVIN T. TRUONG, at 571-272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JESSICA WEISS/Primary Examiner, Art Unit 3775