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 .
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 central component having at least one hollow channel formed therein configured to receive a suture (claims 1 and 22) 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
Applicant is advised that should claim 6 be found allowable, claim 22 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-6 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 1 has been amended to recite that at least one of the superior plate, the inferior plate, or the central component has at least one hollow channel formed therein to receive a suture. Such a recitation constitutes new matter as the originally-filed disclosure fails to provide support for the central component having such a hollow channel. Instead, superior plate 5 has openings 7, 8, 18, and 19 that define hollow channels and inferior plate 6 has openings 14, 15, 22, and 23 that define hollow channels. There is no indication that the central component, which includes proximal central component 1 and distal central component 9, includes such a hollow channel. As such, claim 1 is rejected due to the addition of new matter. Claims 2-6 depend from claim 1 and are therefore also rejected.
Claims 22 and 23 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. New claim 22 recites that at least one of the superior plate, the inferior plate, or the central component has at least one hollow channel formed therein to receive a suture. Such a recitation constitutes new matter as the originally-filed disclosure fails to provide support for the central component having such a hollow channel. Instead, superior plate 5 has openings 7, 8, 18, and 19 that define hollow channels and inferior plate 6 has openings 14, 15, 22, and 23 that define hollow channels. There is no indication that the central component, which includes proximal central component 1 and distal central component 9, includes such a hollow channel. As such, claim 22 is rejected due to the addition of new matter. Claim 23 depends from claim 22 and is therefore also rejected.
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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-5 are rejected under 35 U.S.C. 103 as being unpatentable over Warren et al. (US 2017/0151065 A1) in view of Trieu et al. (US 2008/0058932 A1) and Abernathie (US 2008/0312742 A1).
Claim 1. Warren discloses an expandable intervertebral device (implant 200) for insertion between two vertebral bodies to reestablish an appropriate space and angle of a patient’s spine, comprising:
a central component (wedge members 206 and 208) having proximal (proximal wedge member 206) and distal (distal wedge member 208) central pieces with superior molded angled interlocks (upper guide member 230 of proximal wedge member 206 and upper guide member 232 of distal wedge member 208) and also with inferior molded angled interlocks (lower guide member 270 of proximal wedge member 206 and lower guide member 272 of distal wedge member 208), the proximal and distal central pieces being configured to slide relative to each other along a longitudinal axis of the expandable intervertebral device (compare Figs. 16A and 16B);
a superior plate (upper body portion 202) having proximal and distal ends with molded angled interlocks (slots 220) configured to connect to the superior molded angled interlocks of the proximal and distal central pieces and allow for uninhibited sliding of the superior plate relative to the proximal and distal central pieces (see Figs. 16A and 16B and para. 0176);
an inferior plate (lower body portion 204) having corresponding proximal and distal ends with corresponding molded angled interlocks (slots 222) configured to connect to the inferior molded angled interlocks of the proximal and distal central pieces and allow for uninhibited sliding of the inferior plate relative to the proximal and distal central pieces (see Figs. 16A and 16B and para. 0176); and
a dual-access screw (actuator shaft 210 is a screw as it has threads 294) configured to connect the proximal and distal central pieces along the longitudinal axis and rotate to modulate compression and expansion of the proximal and distal central pieces along the longitudinal axis and corresponding expansion and compression of the superior plate and the inferior plate respectively transverse to the longitudinal axis (see Figs. 16A and 16B and para. 0180) (Figs. 16A-24B; paras. 0158-0184).
Claim 3. Warren discloses wherein each of the proximal and distal central pieces has a respective threaded opening (aperture 274 in proximal wedge member 206 and aperture 276 in distal wedge member 208) configured to receive the dual-access screw to slide the proximal and distal central pieces relative to each other along the longitudinal axis when the dual-access screw is rotated (Figs. 16A-24B; paras. 0158-0184).
Claim 4. Warren discloses wherein the dual-access screw has a head (tool engagement section 296) having a diameter; and a respective opening in a proximal central piece of the proximal and distal central pieces has a corresponding diameter that is greater than the diameter of the head (see Figs. 16A and 16B) (Figs. 16A-24B; paras. 0158-0184).
Claim 5. Warren discloses wherein the dual-access screw has a headless portion (end opposite end with tool engagement section 296) and a body having threads (threads 294) with an inner (root diameter of threads 294) and outer diameter (crest diameter of threads 294); and a distal central piece of the proximal and distal central pieces has a corresponding portion (portion with aperture 276) that is threaded (see para. 0184) and matches the inner and outer diameter of the threads of the body of the dual-access screw (see para. 0184) (Figs. 16A-24B; paras. 0158-0184).
Warren fails to disclose at least one of the superior plate, the inferior plate, or the central component having at least one hollow channel formed therein, extending along the longitudinal axis and configured to receive high-strength suture for fixation during surgery to prevent migration of the expandable intervertebral device once inserted between the two vertebral bodies (claim 1), wherein each of the superior plate and the inferior plate has one or more hollow channels formed therein and configured to receive high-strength suture to be threaded through and subsequent fixation to adjacent osseus structures via bone anchors (claim 2).
Trieu teaches an intervertebral device comprising: a superior plate (plate 143) having at least one hollow channel (para. 0040 states that plate 143 includes apertures extending therethrough to receive sutures) formed therein configured to receive high-strength suture for fixation during surgery to prevent migration of the expandable intervertebral device once inserted between the two vertebral bodies (para. 0040 states that the sutures can be used to secure the intervertebral device to the vertebral bodies); and an inferior plate (plate 148) having at least one hollow channel (para. 0040 states that plate 148 includes apertures extending therethrough to receive sutures) formed therein configured to receive high-strength suture for fixation during surgery to prevent migration of the expandable intervertebral device once inserted between the two vertebral bodies (para. 0040 states that the sutures can be used to secure the intervertebral device to the vertebral bodies); wherein the superior and inferior plates can include bone engagement structures, such as ridges, in addition to the hollow channels for receiving sutures (see para. 0040) (Fig. 3; para. 0040).
Abernathie teaches a superior plate (upper half of plate 20) and an inferior plate (lower half of plate 20) having hollow channels extending along a longitudinal axis of an intervertebral device (cage 10) (see Fig. 1), wherein the hollow channels are configured to receive a fixation element to secure the intervertebral device to the vertebral bodies (see para. 0034) (Figs. 1 and 5; para. 0034).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the intervertebral device of Warren such that at least one of the superior plate, the inferior plate, or the central component having at least one hollow channel formed therein, extending along the longitudinal axis and configured to receive high-strength suture for fixation during surgery to prevent migration of the expandable intervertebral device once inserted between the two vertebral bodies (claim 1), wherein each of the superior plate and the inferior plate has one or more hollow channels formed therein and configured to receive high-strength suture to be threaded through and subsequent fixation to adjacent osseus structures via bone anchors (claim 2), as suggested by Trieu and Abernathie, in order to ensure more secure fixation of the intervertebral device to the adjacent vertebral bodies than would be achieved by only the use of surface ridges (see protrusions 260 in Warren).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Warren et al. (US 2017/0151065 A1) in view of Trieu et al. (US 2008/0058932 A1) and Abernathie (US 2008/0312742 A1) as applied to claim 1 above, and further in view of Biedermann et al. (US 6,176,882 B1).
Claim 6. Warren discloses wherein the dual-access screw includes a proximal end (end with tool engagement section 296) and a distal end (end opposite end with tool engagement section 296), and the proximal end is configured to receive a screwdriver for accessing and turning the dual-access screw (via tool engagement section 296) (Figs. 16A-24B; paras. 0158-0184).
Warren, Trieu, and Abernathie fail to teach wherein the distal end is configured to receive a screwdriver for accessing and turning the dual-access screw (claim 6).
Biedermann teaches an expandable intervertebral device comprising: a superior plate (element 60); an inferior plate (element 61); a central component (wedge members 45 and 46) having proximal and distal central pieces (wedge members 45 and 46); and a dual-access screw (threaded spindle 15) configured to connect the proximal and distal central pieces, wherein the dual-access screw includes proximal and distal ends (first end 16 and second end 17) both configured to receive a screwdriver for accessing and turning the dual-access screw (via first hexagon head 21 and second hexagon head 22) (Fig. 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the intervertebral device of Warren such that the distal end of the dual-access screw is configured to receive a screwdriver for accessing and turning the dual-access screw (claim 6), as suggested by Biedermann, as such would allow the surgeon to access the dual-access screw from both the proximal and distal ends of the intervertebral device, thereby allowing for either proximal or distal end to act as the insertion end or trailing end as needed for a particular patient.
Claims 21 and 24-26 are rejected under 35 U.S.C. 103 as being unpatentable over Warren et al. (US 2017/0151065 A1) in view of Biedermann et al. (US 6,176,882 B1).
Claim 21. Warren discloses an expandable intervertebral device (implant 200) for insertion between two vertebral bodies to reestablish an appropriate space and angle of a patient’s spine, comprising:
a central component (wedge members 206 and 208) having proximal (proximal wedge member 206) and distal (distal wedge member 208) central pieces with superior molded angled interlocks (upper guide member 230 of proximal wedge member 206 and upper guide member 232 of distal wedge member 208) and also with inferior molded angled interlocks (lower guide member 270 of proximal wedge member 206 and lower guide member 272 of distal wedge member 208), the proximal and distal central pieces being configured to slide relative to each other along a longitudinal axis of the expandable intervertebral device (compare Figs. 16A and 16B);
a superior plate (upper body portion 202) having proximal and distal ends with molded angled interlocks (slots 220) configured to connect to the superior molded angled interlocks of the proximal and distal central pieces and allow for uninhibited sliding of the superior plate relative to the proximal and distal central pieces (see Figs. 16A and 16B and para. 0176);
an inferior plate (lower body portion 204) having corresponding proximal and distal ends with corresponding molded angled interlocks (slots 222) configured to connect to the inferior molded angled interlocks of the proximal and distal central pieces and allow for uninhibited sliding of the inferior plate relative to the proximal and distal central pieces (see Figs. 16A and 16B and para. 0176); and
a dual-access screw (actuator shaft 210 is a screw as it has threads 294) configured to connect the proximal and distal central pieces along the longitudinal axis and rotate to modulate compression and expansion of the proximal and distal central pieces along the longitudinal axis and corresponding expansion and compression of the superior plate and the inferior plate respectively transverse to the longitudinal axis (see Figs. 16A and 16B and para. 0180), the dual-access screw having a proximal end (end with tool engagement section 296) and a distal end (end opposite end with tool engagement section 296), the proximal end is configured to receive a screwdriver for accessing and turning the dual-access screw (via tool engagement section 296) (Figs. 16A-24B; paras. 0158-0184).
Claim 24. Warren discloses wherein each of the proximal and distal central pieces has a respective threaded opening (aperture 274 in proximal wedge member 206 and aperture 276 in distal wedge member 208) configured to receive the dual-access screw to slide the proximal and distal central pieces relative to each other along the longitudinal axis when the dual-access screw is rotated (Figs. 16A-24B; paras. 0158-0184).
Claim 25. Warren discloses wherein the dual-access screw has a head (tool engagement section 296) having a diameter; a respective opening in a proximal central piece of the proximal and distal central pieces has a corresponding diameter that is greater than the diameter of the head (see Figs. 16A and 16B); and the dual-access screw has a headless portion (end opposite end with tool engagement section 296) and a body having threads (threads 294) with an inner (root diameter of threads 294) and outer diameter (crest diameter of threads 294) (Figs. 16A-24B; paras. 0158-0184).
Claim 26. Warren discloses wherein the dual-access screw has a headless portion (end opposite end with tool engagement section 296) and a body having threads (threads 294) with an inner (root diameter of threads 294) and outer diameter (crest diameter of threads 294); and the distal central piece of the proximal and distal central pieces has a corresponding portion (portion with aperture 276) that is threaded (see para. 0184) and matches the inner and outer diameter of the threads of the body of the dual-access screw (see para. 0184) (Figs. 16A-24B; paras. 0158-0184).
Warren fails to disclose wherein the distal end is configured to receive a screwdriver for accessing and turning the dual-access screw (claim 21).
Biedermann teaches an expandable intervertebral device comprising: a superior plate (element 60); an inferior plate (element 61); a central component (wedge members 45 and 46) having proximal and distal central pieces (wedge members 45 and 46); and a dual-access screw (threaded spindle 15) configured to connect the proximal and distal central pieces, wherein the dual-access screw includes proximal and distal ends (first end 16 and second end 17) both configured to receive a screwdriver for accessing and turning the dual-access screw (via first hexagon head 21 and second hexagon head 22) (Fig. 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the intervertebral device of Warren such that the distal end of the dual-access screw is configured to receive a screwdriver for accessing and turning the dual-access screw (claim 21), as suggested by Biedermann, as such would allow the surgeon to access the dual-access screw from both the proximal and distal ends of the intervertebral device, thereby allowing for either proximal or distal end to act as the insertion end or trailing end as needed for a particular patient.
Claims 22 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Warren et al. (US 2017/0151065 A1) in view of Biedermann et al. (US 6,176,882 B1) as applied to claim 21 above, and further in view of Trieu et al. (US 2008/0058932 A1) and Abernathie (US 2008/0312742 A1).
Warren and Biedermann fail to teach at least one of the superior plate, the inferior plate, or the central component having at least one hollow channel formed therein, extending along the longitudinal axis and configured to receive high-strength suture for fixation during surgery to prevent migration of the expandable intervertebral device once inserted between the two vertebral bodies (claim 22), wherein each of the superior plate and the inferior plate has one or more hollow channels formed therein and configured to receive high-strength suture to be threaded through and subsequent fixation to adjacent osseus structures via bone anchors (claim 23).
Trieu teaches an intervertebral device comprising: a superior plate (plate 143) having at least one hollow channel (para. 0040 states that plate 143 includes apertures extending therethrough to receive sutures) formed therein configured to receive high-strength suture for fixation during surgery to prevent migration of the expandable intervertebral device once inserted between the two vertebral bodies (para. 0040 states that the sutures can be used to secure the intervertebral device to the vertebral bodies); and an inferior plate (plate 148) having at least one hollow channel (para. 0040 states that plate 148 includes apertures extending therethrough to receive sutures) formed therein configured to receive high-strength suture for fixation during surgery to prevent migration of the expandable intervertebral device once inserted between the two vertebral bodies (para. 0040 states that the sutures can be used to secure the intervertebral device to the vertebral bodies); wherein the superior and inferior plates can include bone engagement structures, such as ridges, in addition to the hollow channels for receiving sutures (see para. 0040) (Fig. 3; para. 0040).
Abernathie teaches a superior plate (upper half of plate 20) and an inferior plate (lower half of plate 20) having hollow channels extending along a longitudinal axis of an intervertebral device (cage 10) (see Fig. 1), wherein the hollow channels are configured to receive a fixation element to secure the intervertebral device to the vertebral bodies (see para. 0034) (Figs. 1 and 5; para. 0034).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the intervertebral device of Warren such that at least one of the superior plate, the inferior plate, or the central component having at least one hollow channel formed therein, extending along the longitudinal axis and configured to receive high-strength suture for fixation during surgery to prevent migration of the expandable intervertebral device once inserted between the two vertebral bodies (claim 22), wherein each of the superior plate and the inferior plate has one or more hollow channels formed therein and configured to receive high-strength suture to be threaded through and subsequent fixation to adjacent osseus structures via bone anchors (claim 23), as suggested by Trieu and Abernathie, in order to ensure more secure fixation of the intervertebral device to the adjacent vertebral bodies than would be achieved by only the use of surface ridges (see protrusions 260 in Warren).
Response to Arguments
Applicant’s arguments with respect to claims 1 and 21 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 JULIANNA N HARVEY whose telephone number is (571)270-3815. The examiner can normally be reached Mon.-Fri. 8:00am-5:00pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Eduardo Robert can be reached 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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/JULIANNA N HARVEY/Primary Examiner, Art Unit 3773