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 without traverse of Species 1B - Fig 3b; Species 2B - Fig 6b; Species 3B - Fig 7b; Species 4B - Fig 8b; Species 5C - Fig 12c; Species 6B - Fig 15b; Species 6B - Fig 16b; Species 7D - Fig 18d; Species 8B - Fig 20b; Species 9B - Fig 21b and Species 10B - Fig 26b in the reply filed on 6/11/2026 is acknowledged.
Drawings
The drawings were received on 10/30/2023. These drawings are accepted.
New corrected drawings for Figures 36a, 36c-m, 36o, in compliance with 37 CFR 1.121(d) are required in this application because a) the lines, numbers, figures and letters are not uniform, clean and well defined (of a generally poor quality) (37 CFR 1.84(I)). They appear to be photocopies. Applicant is advised to employ the services of a competent patent draftsperson outside the Office, as the U.S. Patent and Trademark Office no longer prepares new drawings. The corrected drawings are required in reply to the Office action to avoid abandonment of the application. The requirement for corrected drawings will not be held in abeyance.
Claim Objections
Claims 1-20 are objected to because of the following informalities:
The semi-colon at the end of claim 1 should be a period.
Claim 8 should recite “wherein the [[confirmation]] confirming the one or more operative measurements relative to the one or more preoperative measurements comprises” to stay consistent with claim terminology.
Appropriate correction is required.
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.
Claims 2, 8, 11, 15 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 2 recites “one or more static and dynamic patient positions” where it is not clear if the “one” patient position would include 1. a static position or a dynamic patient position or 2. Both a static and dynamic patient position. For examination purposes, the examiner will treat “one” patient position as being one of static of dynamic.
Claim 6 recites the alternative “the surgical approach comprises a TLIF and/or a PLIF”, where there is an interpretation that the approach is both TLIF and PLIF. As such, it is not clear how the approach can be both the TLIF and PLIF. Clarification is requested.
Regarding claim 11, the phrase “may comprise” is similar to the phrase "such as" and thus renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). For examination purposes, the examiner is treating claim 8 as the localized spine segment comprises L1 to L5 since the spinal region is already defined as the lumbar region in parent claim 10.
Regarding claim 15, the phrase “should be” (which is similar to the phrase "such as") renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). For examination purposes, the examiner is treating the limitation as optional, that the central axis should be positioned as claimed but it is not necessary to do so.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 11 rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 1 recites “at least one localized spine segment in a spine region” where dependent claim 10 recites that the spine region is a “lumbar region” where the lumbar region is L1 to L5 and as such the localized spine segment is in the lumbar region, L1-L5. As such Claim 11 (which recites “the localized spine segment may comprise L1 to L5”) does not further limit the parent claim. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
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.
Claims 1-11, 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pacheco US 2008/0009945.
Regarding Claim 1, Pacheco discloses a method of restoring spinal alignment and range of motion comprises the steps of:
completing a preoperative imaging protocol to acquire at least one image using one or more imaging techniques to create one or more preoperative measurements (paragraph 39, CT, MRI or fluoroscopy is used to generate images of the spine);
selecting a surgical approach (paragraph 49, various approaches are available and selected by the surgeon);
positioning the patient properly (not explicitly disclosed but paragraph 49 that once the approach is selected, the patient would inherently be placed in a proper position to carry out the procedure);
completing an operative imaging protocol to acquire at least one image using one or more imaging techniques (paragraph 51 fluoroscopy is performed) to create one or more operative measurements and confirming the one or more operative measurements relative to the one or more preoperative measurements (paragraph 53 operative measurements are “superimposed” with preoperative measurements);
accessing at least one localized spine segment in a spine region (paragraph 57 where in order to drill, the spine segment is accessed);
selecting a spinal implant size on at least one side (paragraph 42 where the maximum allowed sized implant is determined and an appropriate sized implant is selected, see also paragraph 59, see also Fig 20, 22 where multiple sides of the disc space, including lateral sides “PLC” as seen in Fig 22, one of which can be considered as the “at least one side” are taken into account to determine the appropriate sized implant);
preparing an intervertebral space within the at least one localized spine segment in the spine region on the at least one side (paragraph 57, disc space is prepared via drilling to a desired depth); and
implanting the at least one selected spinal implant into the at least one side (paragraph 59).
Regarding Claim 2, Pacheco discloses the preoperative imaging protocol comprises one or more static and dynamic patient positions (paragraph 39 where CT scan, MRI would be static, likewise fluoroscopy can also be used where when the patient is still, then it would be static but if the patient moves, breathes etc, then it would be dynamic).
Regarding Claim 3, Pacheco discloses the one or more preoperative measurements comprises an angle of correction (paragraph 41, lordosis angle is determined) and/or center of rotation.
Regarding Claim 4, Pacheco discloses the angle of correction comprises a sagittal angle (paragraph 41, lordosis angle is determined which would be in the sagittal plane and thus the correction angle comprises a sagittal angle) and/or a coronal angle.
Regarding Claim 5, Pacheco discloses the one or more imaging techniques comprises a radiograph, an MRI, a CT scan, an ultrasound and/or any combination thereof (paragraph 39, 51, CT, MRI or fluoroscopy can be used).
Regarding Claim 6, Pacheco discloses the surgical approach comprises a TLIF and/or a PLIF (Fig 20 and paragraph 49 where a posterior approach can be used).
Regarding Claim 7, Pacheco discloses the one or more operative measurements comprise the same measurements as the one or more preoperative measurements (paragraph 53 where intraoperative images are superimposed on preoperative images to ensure the two are equal).
Regarding Claim 8, Pacheco discloses the confirmation comprises matching or substantially matching the one or more operative measurements relative to the one or more preoperative measurements (paragraph 53 where intraoperative images are superimposed on preoperative images to ensure the two are equal).
Regarding Claim 9, Pacheco discloses the spine region comprises a cervical region, a thoracic region, a lumbar region, a sacral region, and/or any combination thereof (Fig 19-20, lumbar region).
Regarding Claim 10, Pacheco discloses the spine region comprises a lumbar region (Fig 19-20, lumbar region).
Regarding Claim 11, Pacheco discloses the localized spine segment may comprise L1 to L5 (Fig 19-20, lumbar region).
Regarding Claim 13, Pacheco discloses the step of selecting a spinal implant size comprises the steps of determining a spinal implant length on the at least one side (as discussed in claim 1 above, paragraph 42, Fig 19 where the maximum allowed sized implant is determined and an appropriate sized implant is selected, see also paragraph 59, see also Fig 20, 22 where the dimension, including length, of multiple sides, including the at least one side “PLC”, of the disc space are taken into account to determine the appropriate sized implant ); and
determining the proper spinal implant height on the at least one side (as discussed above and paragraph 42, Fig 19, height in at least one side is also taken into account).
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.
Claims 1, 13-15, 18 are rejected under 35 U.S.C. 103 as being unpatentable over Carls US 2008/0300685 in view of Pacheco US 2008/0009945.
Regarding Claim 1, Carls discloses a method of restoring spinal alignment and range of motion comprises the steps of:
selecting a surgical approach (paragraph 63, TLIF or PLIF is selected);
positioning the patient properly (not explicitly disclosed but in paragraph 63 once the approach is selected, the patient would inherently be placed in a proper position to carry out the procedure);
accessing at least one localized spine segment (Fig 2, where implant #30 is to be implanted in) in a spine region (Fig 1) (paragraph 64 an incision is made to access the localized spine segment);
selecting a spinal implant size on at least one side (paragraph 59, due to the approach and space allowed by the anatomy on at least one side of the spine segment, likewise see also paragraph 60 where patients anatomy is also factored to “create a desired lordosis or kyphosis”);
preparing an intervertebral space within the at least one localized spine segment in the spine region on the at least one side (paragraph 64, disc space is prepared); and
implanting the at least one selected spinal implant into the at least one side (paragraph 65).
Carls discloses the use of fluoroscopy or other visualization methods (paragraph 54) and where the implant is selected based on the surgical approach and anatomy of the patient (paragraph 59-60 where it would be obvious that preoperative imaging would have been required) but does not explicitly disclose completing a preoperative imaging protocol to acquire at least one image using one or more imaging techniques to create one or more preoperative measurements; completing an operative imaging protocol to acquire at least one image using one or more imaging techniques to create one or more operative measurements and confirming the one or more operative measurements relative to the one or more preoperative measurements.
Pacheco discloses a method of restoring spinal alignment and range of motion comprises the steps of:
completing a preoperative imaging protocol to acquire at least one image using one or more imaging techniques to create one or more preoperative measurements (paragraph 39, CT, MRI or fluoroscopy is used to generate images of the spine);
selecting a surgical approach (paragraph 49, various approaches are available and selected by the surgeon);
positioning the patient properly (not explicitly disclosed but paragraph 49 that once the approach is selected, the patient would inherently be placed in a proper position to carry out the procedure);
completing an operative imaging protocol to acquire at least one image using one or more imaging techniques (paragraph 51 fluoroscopy is performed) to create one or more operative measurements and confirming the one or more operative measurements relative to the one or more preoperative measurements (paragraph 53 operative measurements are “superimposed” with preoperative measurements);
accessing at least one localized spine segment in a spine region (paragraph 57 where in order to drill, the spine segment is accessed);
selecting a spinal implant size on at least one side (paragraph 42 where the maximum allowed sized implant is determined and an appropriate sized implant is selected, see also paragraph 59, see also Fig 20, 22 where multiple sides of the disc space, including lateral sides “PLC” as seen in Fig 22, one of which can be considered as the “at least one side” are taken into account to determine the appropriate sized implant);
preparing an intervertebral space within the at least one localized spine segment in the spine region on the at least one side (paragraph 57, disc space is prepared via drilling to a desired depth); and
implanting the at least one selected spinal implant into the at least one side (paragraph 59). Pacheco discloses the “complete a preoperative imaging protocol” step allows one to gather the dimensions of the vertebra (paragraph 39-41) to help determine size of the implant (paragraph 42) and the “completing an operative imaging protocol” provides verification of the preoperative images were proper (paragraph 53).
It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify Carls and include the “complete a preoperative imaging protocol” step and the “completing an operative imaging protocol” step in view of Pacheco above because the “complete a preoperative imaging protocol” step allows one to gather the dimensions of the vertebra to help determine size of the implant and the “completing an operative imaging protocol” provides verification of the preoperative images were proper.
Regarding Claim 13, Carls as modified discloses the step of selecting a spinal implant size comprises the steps of determining a spinal implant length on the at least one side (paragraph 59-60 in Carls and see also paragraph 42, 59, Fig 19-22 in Pacheco where dimensions of the disc space in the at least one side is taken into account in determining the appropriate length of the spinal implant, likewise see paragraph 54 in Carls where measurements are taken to know where central axis #19 is located and to ensure that the center of rotation of the implant is posterior to central axis #19); and
determining the proper spinal implant height on the at least one side (paragraph 59-60 in Carls and see also paragraph 42, 59, Fig 19-22 in Pacheco where dimensions of the disc space in the at least one side is taken into account in determining the appropriate height of the spinal implant).
Regarding Claim 14, Carls as modified discloses the step of determining proper spinal implant length on the at least one side comprises the step of verifying the center of rotation (COR)(see paragraph 54 in Carls where measurements are taken to know where central axis #19 is located and to ensure that the center of rotation of the implant is posterior to central axis #19).
Regarding Claim 15, Carls as modified discloses the COR comprises a central axis (central axis of the COR of the implant #30 of Carls), the central axis should be positioned at least 40% anterior from the posterior end of the caudal endplate of the cranial vertebral body (see 112 rejection above, paragraph 54 in Carls where the center of rotation be located just posterior to the central axis #19 and is able to be at least 40% from posterior end of caudal endplate of vertebral body #14, Fig 2 in Carls).
Regarding Claim 18, Carls as modified discloses the step of preparing an intervertebral space within the at least one localized spine segment in the spine region on the at least one side comprises the steps of:
preparing the caudal vertebral body (V2, Fig 2 in Carls) on the at least one side (paragraph 64);
preparing the cranial vertebral body (V1, Fig 2 in Carls) on the at least one side (paragraph 64);
completing at least one caudal keel channel on the caudal vertebral body on the at least one side (paragraph 64, Fig 1-2 in Carls where a keel channel is made to match keel #58 on a lower end of the implant); and
completing at least one cranial keel channel on the cranial vertebral body and verifying alignment on the at least one side (paragraph 64, Fig 1-2 in Carls where a keel channel is made to match keel #52 on an upper end of the implant).
Regarding Claim 19, Carls as modified discloses the step of preparing the caudal vertebral body on the at least one side comprises the step of preparing a portion of an endplate (paragraph 64 in Carls as discussed above in claim 18, endplate is prepared to create the caudal keel channel) and a portion of a pedicle on the at least one side of the caudal vertebral body to create a caudal resected surface (as seen in Fig 13 in Carls, paragraph 55, 64, the caudal resected surface accommodates the lower surface of the implant #30)(it is noted that Fig 13 shows a different embodiment for the implant but the method of implanting the embodiment shown in Fig 13 is substantially the same for implant #30, see paragraph 84, 87).
Regarding Claim 20, Carls as modified discloses the resected surface comprises a path trajectory (since the implant is implanted along the resected surface as discussed above, paragraph 64, 55-56), the path trajectory follows along, matches or substantially matches the transverse pedicle angle (paragraph 56, Fig 3 where fastener #68 extends through a pedicle extrapedicularly and thus when looking at the disc space in along a transverse plane, the path trajectory for the implant would match or substantially match the transverse pedicle angle).
Claims 12, 17 are rejected under 35 U.S.C. 103 as being unpatentable over Carls US 2008/0300685 and Pacheco US 2008/0009945, as applied claim 1 above, and in further view of Glenn US 2004/0059421.
Regarding Claim 12, Carls as modified discloses wherein the step of selecting a spinal implant size comprises the steps of: determining a spinal implant length on the at least one side (paragraph 59-60 in Carls and see also paragraph 42, 59, Fig 19-22 in Pacheco where dimensions of the disc space in the at least one side is taken into account in determining the appropriate length of the spinal implant, likewise see paragraph 54 in Carls where measurements are taken to know where central axis #19 is located and to ensure that the center of rotation of the implant is posterior to central axis #19); and
determining the proper spinal implant height on the at least one side (paragraph 59-60 in Carls and see also paragraph 42, 59, Fig 19-22 in Pacheco where dimensions of the disc space in the at least one side is taken into account in determining the appropriate height of the spinal implant).
Carls does not disclose completing soft tissue balancing on at least one side.
Glenn teaches that correcting a spinal deformity by restoring overall disc space height and restoring lordosis by completing soft tissue balancing via distracting vertebrae and placing adjacent soft tissue structures in tension (see paragraph 3, which states that ligaments are placed in tension and height of the disc space is restored).
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 method of Carls as modified by completing a first soft tissue balancing on at least one side in view of Glenn in order to correct a spinal deformity and to hold the vertebra in a fixed position. Examiner notes that since the disc space height is to be restored tissue balancing would be performed on the at least one side.
Regarding Claim 17, Carls as modified discloses the step of determining proper spinal implant height on the at least one side comprises the step of verifying tissue balancing and spinal implant plane angulation (paragraph 3 in Glenn and paragraph 42, the tissue balancing would have to be verified in order to provide a desired disc height and restore lordosis of the disc space and then appropriate spinal implant height and plane angulation for lordosis for the implant would then then be determined).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Carls US 2008/0300685, Pacheco US 2008/0009945 and Glenn US 2004/0059421, as applied to claim 12 above and in further view of Peterman WO 2020/097613.
Carls as modified discloses the claimed invention as discussed above where the implant is introduced along the transverse pedicle angle (paragraph 56, 59 in Carls, see also rejection for claim 20 above) but does not disclose the step of determining proper spinal implant length on the at least one side comprises the step of introducing at least one length trial on the at least one side that follows along the transverse pedicle angle.
Peterman discloses a method of implanting a spinal implant (Fig 8a), and the step of determining proper spinal implant length on the at least one side comprises the step of introducing at least one length trial on the at least one side that follows along the transverse pedicle angle (paragraph 87, as seen in Fig 14 where a trial is implanted along one side of the disc space along the transverse pedicle angle)(it is noted that two trials are used along opposing sides of the disc), where the trial is used to ensure that a desired angular correction has been established, and/or that a desired tension of the lateral annulus will be achieved once the final implant has been emplaced (paragraph 87) .
It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify the method of Carls as modified to introduce a trial along the transverse pedicle angle in view of Peterman above because the trial is used to ensure that a desired angular correction has been established, and/or that a desired tension of the lateral annulus will be achieved once the final implant has been emplaced.
Conclusion
See PTO-892 for art of cited interest, in particular other references which show implants being implanted within one side of the disc space.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAN CHRISTOPHER L MERENE whose telephone number is (571)270-5032. The examiner can normally be reached Mon-Fri 8:30 am - 6pm EST.
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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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/JAN CHRISTOPHER L MERENE/Primary Examiner, Art Unit 3773
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