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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 10/27/2025 has been entered.
Priority
This application claims priority from provisional application 61/020,082, filed 01/09/2008.
Status of Claims
Claims 1-15 are pending.
Information Disclosure Statement
The information disclosure statement filed on 10/28/2025 has been considered.
Drawings
The drawings remain objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore the step of delivering the implant between first and second articulating subchondral surfaces of the facet joint (claims 1 and 11) 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 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 1-15 are rejected under 35 U.S.C. 103 as being unpatentable over Moskovitz et al (Moskovitz) USPN 5,891,147 in view of Bryan USPN 6,500,206 B1 and Schmitz et al (Schmitz) US 2007/0225703 A1.
Moskovitz discloses the invention substantially as claimed being a method of minimally invasively accessing a facet joint to deliver an implant between a first and second articulating subchondral surface of the facet joint (Figures 3 and 19), the method comprising:
accessing the facet joint from a posterior-lateral approach (10 Figure 3) by piercing a facet capsule with a facet access tool (8:47-9:6 Figures 8-9), the facet access tool 50 comprising:
an elongate handle 56/59 having a proximal end and a distal end (Figure 29B); decorticating the facet joint with a decortication apparatus (Burr described in 10:14-24); and
delivering an implant between the first and second articulating subchondral surfaces of the facet joint (10:41-50) via an implant introducer (110 Figure 20) comprising an elongate shaft 111 having a proximal end and a distal end opposite the proximal end.
However, Moskovitz does not disclose the blade structure of the facet access tool or the specific structure of the decortication apparatus.
Bryan teaches the use of a system of spinal instruments including an access tools (Figures 8D-F) including blades with flat leading edges in the same field of endeavor for the purpose of enabling cutting and shaping of the access tunnel.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to combine the flat cutting edge of Bryan with the leading edge of the facet access tool of Moskovitz in order to enable the operator to cut a cleaner access tunnel.
Schmitz teaches the use of a decortication apparatus comprising a flexible rasp (10 Figure 3A-B [0083]) comprising a plurality of shafts including at least one with a beveled distal end (13 has blower distal end near shaft 14 with a beveled shape as clearly seen in Figure 3B) in the same field of endeavor for the purpose of flexing down a curved tunnel to remove tissue or bone.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to replace the rasp of combination 1 with the flexible rasp of having a shaft with a beveled distal end of Schmitz in order to better accommodate the curves of the access tunnel and conform to the site being modified.
2. 7. and 12. Schmitz discloses the decortication apparatus 10 comprises a flat (rasp portions of embodiments shown in Figures 5A-21), flexible [0002], spatula-shaped (spatulas come in all shapes and sizes including elongated rectangles like those of embodiments shown in Figures 5A-21) rasp configured to decorticate at least one of the articulating surfaces [0013].
3. 8. and 13. Schmitz discloses the shaft of the decortication apparatus is attached to the rasp (as seen in Figures 3A-B all pieces of the decortication apparatus are connected to each other including the shaft 13 and rasp).
4. 9. and 14. Schmitz discloses the decortication apparatus comprises a flat device with cutting surface (rounded and rolled cutting surfaces edges shown in Figures 9, 10, 14, 15, 20, 21, or 43-51) configured to be used with a rolling motion (the device is capable of any type of motion because it has a handle that allows for rolling) decorticate at least one of the articulating surfaces.
5. 10. and 15. Moskovitz discloses the implant comprises bone material (allograft 10:51-59).
6. Moskovitz discloses an system for minimally invasively accessing an interior region of a facet joint to deliver an implant from a posterior-lateral approach (explained above), the facet joint comprising first and second articulating subchondral surfaces defining first and second boundaries of a facet cavity, the facet joint further comprising a facet capsule defining a third boundary of the facet cavity (the language defining where and how the system is used is considered intended use and given limited weight, as explained above the system of Moskovitz is fully capable of performing as claimed), the system comprising:
a facet access tool configured to pierce the capsule (50 Figures 8-9, the tool as modified is fully capable of piercing the fragile material of the capsule with its blade) the tool comprising: an elongate handle 56/59 having a proximal end and a distal end; and
a blade disposed at the distal end of the handle 52, the blade comprising a flat leading edge (see modification above in view of Bryan);
a decortication apparatus configured to decorticate at least one of the first and second articulating subchondral surfaces (Burr described in 10:14-24); and
an implant introducer (110 Figure 20) comprising an elongate shaft 111 having a proximal end and a distal end opposite the proximal end, wherein the introducer delivers an implant between the first and second articulating subchondral surfaces of the facet joint (10:41-50).
11. Moskovitz discloses a method of minimally invasively delivering an implant to a facet joint with the system of claim 6 between the first and second articulating subchondral surfaces of the facet joint from a posterior-lateral approach (see explanations above), the method comprising: accessing the facet joint with the facet access tool by piercing the facet capsule (8:47-9:6 50 Figures 8-9); decorticating the facet joint with the decortication system (Burr described in 10:14-24); and delivering the implant into the facet joint (10:41-50) via the introducer (110 Figure 20).
Response to Arguments
Applicant's arguments filed 10/28/2025 have been fully considered but they are not persuasive.
In regards to the drawing objections the applicant cited Figure 10 and paragraphs [0088]-[0093] for support for the step of delivering the implant between the first and second articulating subchondral surfaces. However neither of these portions overcome the drawing objection. Specifically Figure 10 does not show any implant or the portions of the implant site it contacts because it is showing earlier steps of using tools to prep the site. Furthermore the cited portions of the specification does not clarify as to where the implant is depicted because they describe the steps and tools shown in Figure 10.
In regards to the prior art rejection the applicant argues that the claimed distraction apparatus with a shaft including a beveled surfaces is not disclosed by the prior art. As an initial note the claims (1, 3, 6, and 8) are requiring the decortication apparatus to have the shaft with beveled surface not a distraction apparatus. If the applicant intended for the other to be claimed the claims must be further amended. Additionally, the prior art combination relies on Schmitz for teaching the claimed decortication apparatus. Schmitz clearly discloses a tool with a plurality of shafts including 13 which has a beveled distal end shown best in Figure 3B.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER D PRONE whose telephone number is (571)272-6085. The examiner can normally be reached Monday-Friday 10 am - 6 pm (HST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie R Tyson can be reached on (571)272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Christopher D. Prone/Primary Examiner, Art Unit 3774