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 .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim(s) 6-7 is/are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 6 recites the limitations "the first intradiscal implant" in line 1 and “the second intradiscal implant” in line 2. There is insufficient antecedent basis for this limitation in the claim. It appears that the claim should instead recite “the first rod” and “the second rod” in order to refer back to the limitations in claim 1 and have sufficient antecedent basis, and for the purpose of compact prosecution, will be examined below under this assumption.
Claim 7 recites the limitation "the first and second intradiscal implants" in line 1. There is insufficient antecedent basis for this limitation in the claim. It appears that the claim should instead recite “the first rod” and “the second rod” in order to refer back to the limitations in claim 1 and have sufficient antecedent basis, and for the purpose of compact prosecution, will be examined below under this assumption.
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.
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.
Claim(s) 1-4, 6-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over McGraw et al. (U.S. Pub. No. 2008/0033432 A1, hereinafter “McGraw”) in view of Matityahu et al. (U.S. Pub. No. 2010/0016903 A1, hereinafter “Matityahu”) and in view of Sharifi-Mehr (U.S. Patent 10,485,675 B2, hereinafter “Sharifi-Mehr”).
McGraw discloses, regarding claim 1, a system for stabilizing the spine (see Fig. 2) comprising: a first rod (10, see Fig. 2) from configured to be positioned through an ipsilateral pedicle of the inferior vertebra (L5, see Fig. 2), thru the disc space (20, see Fig. 2), and into a vertebral body of the superior vertebra (L4, see Fig. 2); a second rod (10, see para. [0050] “the procedure is repeated on the contralateral side, producing a total of four stabilization devices 10, 10’ used at each level to be stabilized”) configured to be positioned through a contralateral pedicle of the inferior pedicle (L5, see Fig. 2), thru the disc space (20, see Fig. 2), and into the vertebral body of the superior vertebra (L4, see Fig. 2).
Regarding claim 6, wherein the first rod is deployed through an ipsilateral cannula (16, see Fig. 2) and the second rod is deployed through a contralateral cannula (16, see para. [0050]).
Regarding claim 8, wherein the first and second rods are each deployed with a deployment instrument (16 and 29) having a deployment tube (16) and a shaft (46) with an impaction cap (54, see para. [0063]), wherein each rod is deployed by striking the impaction cap (see para. [0063]), thereby forcing the rod to deploy out of the deployment tube (see para. [0063]).
McGraw fails to disclose, regarding claim 1, an expandable interbody implant configured to be positioned in a disc space between superior and inferior vertebrae, the expandable interbody implant having three articulating and expandable legs; a first pedicle screw positioned through the ipsilateral pedicle of the inferior vertebra and driving the first pedicle screw over the first rod to anchor the first rod; a second pedicle screw positioned through the contralateral pedicle of the inferior pedicle and driving the second pedicle screw over the second rod to anchor the second rod; regarding claim 2, wherein the three legs of the expandable interbody implant are articulated relative to one another to increase the overall footprint of the implant; regarding claim 3, wherein the expandable interbody implant is placed along the apophyseal ring of the vertebrae for cortical bone support; regarding claim 4, wherein the expandable interbody implant is expanded to independently control sagittal and coronal correction; and regarding claim 7, wherein the first and second rods are positioned medially relative to the expandable interbody implant.
Matityahu discloses a system for stabilizing the spine (see Fig. 10) with first and second rods (38, see Figs. 7-8), wherein the system further includes a first pedicle screw (30) positioned through the ipsilateral pedicle of the inferior vertebra and driving the first pedicle screw over the first rod to anchor the first rod (see Fig. 7); a second pedicle screw (31)positioned through the contralateral pedicle of the inferior pedicle and driving the second pedicle screw over the second rod to anchor the second rod (see Fig. 8) in order to enable the rods to be attached to pedicle screws to allow interconnection with rods via tulips (see para. [0068]) to provide stabilization and immobility of adjacent vertebrae (see para. [0039]).
Sharifi-Mehr discloses an expandable interbody implant (see Figs. 18-21B) in a disc space between superior and inferior vertebrae (see Fig. 19, note that the disc space is between a superior and inferior vertebrae), the expandable interbody implant having three articulating and expandable legs (212, 214, 215, see also lines 1-14 of column 16 “pistons 238 may be independently controlled”); wherein the three legs of the expandable interbody implant are articulated relative to one another to increase the overall footprint of the implant (see Figs. 18-19, note that the legs have been pivoted to create a larger footprint in Fig. 19); wherein the expandable interbody implant is placed along the apophyseal ring of the vertebrae for cortical bone support (see Fig. 19); wherein the expandable interbody implant is expanded to independently control sagittal and coronal correction (see lines 1-14 of column 16 “pistons 238 may be independently controlled”) in order to provide a spacer between two vertebrae being treated providing additional stability (see lines 14-24 of column 1) and to apply different forces at different locations along the implant to create different amounts of expansion to correct lordosis (see lines 59-67 of column 13).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system in McGraw to include a first pedicle screw positioned through the ipsilateral pedicle of the inferior vertebra and driving the first pedicle screw over the first rod to anchor the first rod; a second pedicle screw positioned through the contralateral pedicle of the inferior pedicle and driving the second pedicle screw over the second rod to anchor the second rod in view of Matityahu in order to enable the rods to be attached to pedicle screws to allow interconnection with rods via tulips to provide stabilization and immobility of adjacent vertebrae. And it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system in McGraw to include an expandable interbody implant configured to be positioned in a disc space between superior and inferior vertebrae, the expandable interbody implant having three articulating and expandable legs that are articulated relative to one another to increase the overall footprint of the implant and expanded to independently control sagittal and coronal correction in view of Sharifi-Mehr in order to provide a spacer between two vertebrae being treated providing additional stability and to apply different forces at different locations along the implant to create different amounts of expansion to correct lordosis. It is noted that the first and second rods in McGraw would be positioned medially relative to the expandable interbody implant of Sharifi-Mehr.
Allowable Subject Matter
Claim(s) 9-10 is/are allowed.
Claim(s) 5 is/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.
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:
A system for stabilizing the spine comprising: an expandable interbody implant, the expandable interbody implant having three articulating and expandable legs; a first rod from configured to be positioned through an ipsilateral pedicle of the inferior vertebra, thru the disc space, and into a vertebral body of the superior vertebra; a second rod configured to be positioned through a contralateral pedicle of the inferior pedicle, thru the disc space, and into the vertebral body of the superior vertebra; and
a first pedicle screw positioned over the first rod to anchor the first rod; and a second pedicle screw positioned over the second rod to anchor the second rod; and as per claim 5, wherein the expandable interbody implant is positioned in the disc space by inserting a magnetic cable assembly attached to the expandable interbody implant through an ipsilateral cannula, inserting an articulating magnet retrieval tool through a contralateral cannula to magnetically attract and connect to the magnetic cable assembly, and retracting the articulating magnet retrieval tool back through the contralateral cannula, thereby pulling the cable assembly into the contralateral cannula and positioning the expandable interbody implant in the disc space.
A system for stabilizing two adjacent vertebrae comprising: an expandable interbody implant; the expandable interbody implant having a first expandable lateral leg, a second expandable lateral leg, and a third central leg pivotably connected between the first and second lateral legs; and as per claim 9, a cable assembly including a cable with a magnetic tip at one end and attachable to an expandable interbody implant at the other end, an articulating magnet retrieval tool configure to be positioned through a contralateral cannula; wherein the articulating magnet retrieval tool is configured to magnetically attract and connect to the magnetic tip of the cable assembly.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michelle C. Green whose telephone number is (571)270-7051. The examiner can normally be reached on Monday-Friday between 9am-5pm.
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, please contact the examiner’s supervisor, Eduardo C. Robert, at (571) 272-4719. 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.
/M.C.G/ Examiner, Art Unit 3773 /EDUARDO C ROBERT/ Supervisory Patent Examiner, Art Unit 3773
Prosecution Insights