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 .
Election/Restrictions
Applicant’s election of Species 2, shown in Figs. 11-14 in the reply filed on 08/25/2025 is acknowledged. The traversal is on the ground(s) “that the embodiment of Figure 10 was inadvertently included in the embodiment of Figures 11 through 14 by Applicant, and Applicant filed herewith a Substitute Specification (Marked-Up and Clean Copies) and a Replacement Drawing Sheet for Figure 10 which clarifies that the embodiments of Figures 10 and Figures 11 through 14 are separate embodiments, even though these embodiments may share many similar features and/or uses thereof.” The examiner acknowledges that Species 2 is illustrated in Figs. 11-14.
The requirement is still deemed proper and is therefore made FINAL.
Claim Rejections - 35 USC § 102
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 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) 1-2 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Carls et al. (U.S. 2008/0300685 A1).
Concerning claim 1, Carls et al. discloses a surgical method for creating a desired lordosis or kyphosis between a first upper vertebrae and a second lower vertebrae, comprising:
removing at least a portion of a natural intervertebral disc from between the upper and lower vertebrae to create a disc space (see par. 0006); resecting at least a portion of a natural endplate (see par. 0064) and at least a portion of a natural pedicle (see par. 0055) of the lower vertebrae to create a resected lower vertebral surface which exposes a cancellous bone (see Fig. A below – noting that element 58 is structured to engage and therefore expose cancellous bone) interior of the lower vertebra and which extends outside of the disc space (cancellous bone is exposed out of the disc space by removal of the pedicle); inserting a lower portion of a first arthroplasty device (see Fig. 3, element 34) at least partially into the disc space, the first arthroplasty device including a lower surface (see Fig. 3, element 50 and par. 0064) that substantially matches the resected lower vertebral surface and extends at least partially outside of the disc space; and attaching the first arthroplasty device to the lower vertebrae with a bone fastener (see Fig. 3, element 68 and par. 0068).
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Concerning claim 2, wherein the bone fastener extends through at least a portion of a cortical wall of the resected pedicle (see par. 0068). Extension through the pedicle results in extension through at least a portion of a cortical wall of the resected pedicle.
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.
Claim(s) 3-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Carls et al. (U.S. 2008/0300685 A1).
Carls et al. disclose the invention substantially as described above. However, Carls et al. do not explicitly disclose that the bone fastener extends through a central axis of the resected pedicle.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Carls’ method by simply altering the fastener extension angle through the resected pedicle because doing so may be necessary to grip the best portion of the receiving bone, or to avoid other implants or nerves. The spine is a delicate region and implant placement, and anchoring methods vary by the specific anatomy and needs of the patient. An operating surgeon would radiograph the implant region and ensure a proper trajectory and depth of the screw that provides optimal stability and avoids damage to nerves and blood vessels.
Regarding claim 4, Carls et al. do not explicitly disclose that the step of resecting at least a portion of the natural endplate and at least a portion of the natural pedicle of the lower vertebrae is accomplished concurrently. It is noted that depending on patient anatomy – including other implants or neural structures that require avoidance, the operating surgeon could utilize a tool to resect both a portion of the endplate and portion of the natural pedicle concurrently. In fact, implantation of screw 68 would resect at least a portion of the natural endplate and at least a portion of the natural pedicle at the same time during threading into bone.
Regarding claim 5, it is noted that Carls discloses the use of a rasp (see par. 0064) to resect vertebral portions. As stated above, one of ordinary skill in the art before the effective filing date of the claimed invention would find it obvious to resect at least a portion of the natural endplate and at least a portion of the natural pedicle of the lower vertebrae concurrently. The utilization of a powered rasp for this step is inherent as it is well known that powered surgical tools include greater precision, efficiency, and accuracy in procedures leading to shorter operation time and improved patient recovery.
Claim(s) 6-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Carls et al. (U.S. 2008/0300685 A1) in view of Lang et al. (U.S. 8,062,302 B2).
Carls et al. disclose the invention substantially as described above. However, Carls et al. do not explicitly disclose that the step of resecting at least a portion of the natural endplate and at least a portion of the natural pedicle of the lower vertebrae is accomplished by a surgical robot.
Lang et al. teach the use of a robotic device to prepare an implant site in the same field of endeavor (see col. 80, lines 31-33).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to utilize a surgical robot to resect the endplate and pedicle, the concept of which is disclosed by Lang et al., in order to enhance the precision and accuracy of the resection by reducing the instance of human tremor. It is also well known that the use of robotics permits smaller incisions leading to reduced tissue trauma.
Regarding claim 7, Lang et al. also teach the use of surgical guidance systems (see col. 30, lines 18-32). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to utilize a surgical guidance system when resecting at least a portion of the natural endplate and at least a portion of the natural pedicle of the lower vertebrae, as taught by Lang et al., in order to avoid nerves or other critical structures near the resection region leading to better patient recovery time.
Claim(s) 8-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Carls et al. (U.S. 2008/0300685 A1) in view of Humphreys et al. (U.S. 2005/0171610 A1).
Carls et al. disclose a surgical method for creating a desired lordosis or kyphosis between a first upper vertebrae and a second lower vertebrae, comprising: removing at least a portion of a natural intervertebral disc from between the upper and lower vertebrae to create a disc space (see par. 0064); resecting at least a first portion of a natural endplate and at least a first portion of a first natural pedicle of the lower vertebrae to create a first resected lower vertebral surface which exposes a cancellous bone interior of the lower vertebra and which extends outside of the disc space (see par. 0064 – trimming of facet; see also Fig. A above which illustrates the location of cancellous bone). The cancellous bone would be exposed during the resection of the vertebral body endplate to match the outer profile of the implant – see Fig. 3, element 58). The method further includes the step of inserting a lower portion of a first arthroplasty device at least partially into the disc space, the first arthroplasty device including a first lower surface that substantially matches the first resected lower vertebral surface and extends at least partially outside of the disc space (see par. 0064 and Fig. 13 which illustrates extension of an implant out of the disc space); and attaching the first arthroplasty device to the lower vertebrae with a first bone fastener (see Fig. 3, element 68).
However, Carls et al do not disclose the additional steps of resecting at least a second portion of the natural endplate and at least a second portion of a second natural pedicle of the lower vertebrae to create a second resected lower vertebral surface which extends outside of the disc space;
inserting a lower portion of a second arthroplasty device at least partially into the disc space, the second arthroplasty device including a second lower surface that substantially matches the second resected lower vertebral surface and extends at least partially outside of the disc space; and
attaching the second arthroplasty device to the lower vertebrae with a second bone fastener.
Humphreys et al. teach a surgical method for creating a desired lordosis or kyphosis between upper a first upper vertebrae and a second lower vertebrae by utilizing two separate implants.
It would have been obvious to one having ordinary in the art before the effective filing date of the claimed invention to modify Carls’ method by including two smaller sized implants that fit on each side of a patient’s spine, the concept of which is disclosed by Humphreys et al., in order address spinal degradation which may differ from side to side and therefore distribute compressive loads more evenly. Furthermore, the use of two separate implants within a single disc space leads to an increased surface area and biomechanical stability. Finally, it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
Regarding claims 9 and 10, it is noted that one of ordinary skill in the art before the effective filing date of the claimed invention would find it obvious to form the first resected lower vertebral surface nonparallel/non-coplanar to the second resected lower vertebral surface after analyzing the patient’s spine and addressing the placement in the best way to enhance mobility and stability of the implants within the disc space. As noted above, spinal degradation or previous injury or implant may require different implant positioning from side to side.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELLEN HAMMOND whose telephone number is (571)270-3819. The examiner can normally be reached Monday-Friday 8 - 4 PM .
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.
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/ELLEN C HAMMOND/Primary Examiner, Art Unit 3773