DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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.
Claim 1, 7, and 12-15is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Moskowitz et al. (Pat. No. US 7,083,650 B2) in view of Boehm JR et al. (Pub. No. US 2006/0217754 A1).
Regarding claims 1, 7, and 14, Moskowitz et al. discloses a method for intervertebral implant placement (col. 14, lines 12-30), comprising: inserting a distractor tool into a patient (col. 14, lines 12-30); performing disc removal through the protected surgical corridor while the distractor tool remains expanded (col. 14, lines 23-26); inserting an interbody device 100 through an internal passage of the distractor tool while the distractor tool maintains distraction (col. 14, lines 12-30); actuating a deployment mechanism 102 of the interbody device 100 to reposition structural elements of the interbody device within the intervertebral space (figures 1A-1B); and actuating an expansion mechanism of the interbody device to achieve a selected implant geometry prior to removal of the distractor tool (figures 2A-2B; col. 14, lines 12-30). The protected surgical corridor enables placement of an implant having an anterior-posterior footprint exceeding that of the distractor tool prior to deployment (this is a functionally recited limitation. The corridor can enable placement of an expandable implant, so it meets the claimed limitations).
Moskowitz et al. discloses the claimed invention except wherein the distractor tool is inserted into the intervertebral space, the distractor tool having actuatable anterior-posterior and rostral-caudal expandable structures; expanding the distractor tool to create a protected surgical corridor that shields posterior neural elements and anterior vascular structures; wherein the expansion mechanism of the distractor tool includes a first pair of blades to controllably expand or retract in the anterior- posterior direction, and a second set of blades to controllably expand or retract in the rostral- caudal direction.
Boehm et al. teaches a method comprising a distractor tool 15 that is inserted into the intervertebral space (figure 12), the distractor tool 15 having actuatable anterior-posterior and rostral-caudal expandable structures 16; expanding the distractor tool 15 to create a protected surgical corridor that shields posterior neural elements and anterior vascular structures (figure 13); wherein the expansion mechanism of the distractor tool includes a first pair of blades to controllably expand or retract in the anterior- posterior direction, and a second set of blades to controllably expand or retract in the rostral- caudal direction (figure 13). Boehm et al. teaches that using an expandable distractor tool is advantageous because it allows a broader range of surgical procedures to be carried out. Additionally, it allows for a smaller incision.
It would have been obvious to a person having ordinary skill in the art at the time the invention was effectively filed to modify the method disclosed by Moskowitz et al., such that the distractor tool is an expandable distractor tool, as taught by Boehm et al., wherein the distractor tool is inserted into the intervertebral space, the distractor tool having actuatable anterior-posterior and rostral-caudal expandable structures; expanding the distractor tool to create a protected surgical corridor that shields posterior neural elements and anterior vascular structures; wherein the expansion mechanism of the distractor tool includes a first pair of blades to controllably expand or retract in the anterior- posterior direction, and a second set of blades to controllably expand or retract in the rostral- caudal direction, in order to provide a distractor tool which can alleviate the pressure in the vertebral disc by expanding in the intervertebral space, be inserted through a smaller incision, and protect the surrounding tissue.
Regarding claim 12, as modified, disc removal, implant insertion, implant deployment, and implant expansion are performed without releasing distraction between steps (Boehm et al. teaches that the distractor tool is used during insertion of artificial discs. In order to insert the artificial disc, the distraction must be maintained during all steps of the process).
Regarding claim 13, Moskowitz et al. discloses the step of fluoroscopic confirmation of implant position (col. 13, line 45-col. 14, lines 5), and Boehm et al. teaches that the distractor is utilized during the insertion of the spinal prosthesis. Therefore, as modified, fluoroscopic confirmation of implant position is carried out prior to release of the distractor tool.
Regarding claim 15, as modified, the steps of actuating the deployment mechanism and actuating the expansion mechanism are performed while the distractor tool remains expanded because the distractor tool as taught by Boehm et al. is utilized during the entire insertion of the interbody device.
Claims 16-21 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Moskowitz et al. Pat. No. US 7,083,650 B2) in view of Smith et al. (Pub. No. US 2007/0208227 A1).
Regarding claims 16-20, Moskowitz et al. discloses an intervertebral implant system, comprising: an interbody device 100 having a compact insertion configuration (figure 4A) and a deployed configuration (figure 4D), the device 100 including: first and second structural elements (Q1/Q2/Q3/Q4 and Q5, Q6, Q7, Q8) movable relative to one another within an intervertebral space (figures 4A-4D); at least one deployment mechanism 102 operable to reposition the first and second structural elements relative to one another after insertion (the portion of 102 which adjusts the width, figure 4D); and at least one expansion mechanism 102 operable to change a dimension of at least one of the structural elements within the intervertebral space (the portion of 102 which changes the height/width of the structural elements as shown in figures 4B and 4C); and a distractor tool “endoscope” (col. 14, lines 14-22) comprising: an elongate body defining an internal passage sized to receive the interbody device therethrough (col. 14, lines 14-22); wherein the distractor tool is configured to maintain protection of neural and vascular structures while permitting deployment of the interbody device from the compact insertion configuration to the deployed configuration within the intervertebral space (col. 14, lines 12-25). The internal passage of the distractor tool is configured to receive at least one of the interbody device, a disc removal instrument, and an inserter or deployment tool (col. 14, lines 12-22). The interbody device remains mechanically coupled to an inserter tool during deployment and expansion (col. 13, lines 35-60).
Moskowitz et al. discloses the claimed invention except wherein the distractor tool comprises a first expandable structure configured to expand in an anterior-posterior direction to create a protected anterior corridor; and a second expandable structure configured to expand in a rostral-caudal direction to create a protected superior-inferior corridor, wherein the first expandable structure and the second expandable structure are mechanically independent and configured to independently lock; wherein the distractor tool includes mechanical limits to prevent overexpansion; wherein the first and second expandable structures self-maintain at selected distraction settings without an external manual force;
Smith et al. teaches a distractor tool (figure 67) wherein the distractor tool comprises a first expandable structure 10 configured to expand in an anterior-posterior direction to create a protected anterior corridor; and a second expandable structure 300 configured to expand in a rostral-caudal direction to create a protected superior-inferior corridor (figure 67), wherein the first expandable structure 10 and the second expandable structure 300 are mechanically independent and configured to independently lock (figure 66); wherein the distractor tool includes mechanical limits to prevent overexpansion 36 and 328 (figure 66); wherein the first and second expandable structures 10, 300 self-maintain at selected distraction settings without an external manual force (figure 66). Smith et al. teaches that it is advantageous to include such a distraction tool because it provides a less invasive access to the surgical site while avoiding neural structures (paragraph 0101).
It would have been obvious to a person having ordinary skill in the art at the time the invention was effectively made to modify the distractor tool such that it comprises a first expandable structure configured to expand in an anterior-posterior direction to create a protected anterior corridor; and a second expandable structure configured to expand in a rostral-caudal direction to create a protected superior-inferior corridor, wherein the first expandable structure and the second expandable structure are mechanically independent and configured to independently lock; wherein the distractor tool includes mechanical limits to prevent overexpansion; wherein the first and second expandable structures self-maintain at selected distraction settings without an external manual force, as taught by Smith et al., in order to provide a distractor to establish a minimally invasive corridor which avoids neural structures and is adaptable to the patient’s anatomy and the surgeon’s needs.
Claim 22 and 23 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Moskowitz et al. Pat. No. US 7,083,650 B2) in view of Smith et al. (Pub. No. US 2007/0208227 A1) and further in view of Ferree (Pub. No. US 2004/0249461 A1).
Regarding claims 22 and 23, Moskowitz et al. as modified by Smith et al. disclose the claimed invention except wherein the system further comprising a flexible containment structure deployable through the distractor tool after deployment of the interbody device; wherein the containment structure is configured to expand following deployment of the interbody device to occupy void spaces created by repositioning of the structural elements.
Ferree et al. teaches wherein a system further comprises a flexible containment structure 300 deployable through the distractor tool after deployment of the interbody device; wherein the containment structure 300 is configured to expand following deployment of the interbody device to occupy void spaces created by repositioning of the structural elements (figure 4-5B), for the purpose of containing graft material (paragraph 0054).
It would have been obvious to a person having ordinary skill in the art at the time the invention was effecit3elvy filed to modify the system disclose by Moskowitz et al. and Smith et al. to further comprise a flexible containment structure deployable through the distractor tool after deployment of the interbody device; wherein the containment structure is configured to expand following deployment of the interbody device to occupy void spaces created by repositioning of the structural elements, as taught by Ferree et al., for the purpose of containing graft material that can be inserted into the device to assist in bony ingrowth.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 and 7 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 Lynnsy Summitt whose telephone number is (571)270-78567856. The examiner can normally be reached on Monday through Thursday from 8am until 5pm.
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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/LYNNSY M SUMMITT/ Primary Examiner, Art Unit 3773
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