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 .
Information Disclosure Statement
Applicant should note that the large number of references in the attached IDS have been considered by the examiner in the same manner as other documents in Office search files are considered by the examiner while conducting a search of the prior art in a proper field of search. See MPEP 609.05(b). Applicant is requested to point out any particular references in the IDS which they believe may be of particular relevance to the instant claimed invention in response to this office action.
The information disclosure statement filed 6/10/2024 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document (cite #10, #12 on pg 29); each non-patent literature publication (NPL Cite #1 on pg 4) or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered.
The information disclosure statement filed 6/12/2024 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document (cite #39, #40, #44 on pgs 9-10); each non-patent literature publication (NPL Cite #4 on pg 10) or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered.
The information disclosure statement filed 6/10/2024 fails to comply with 37 CFR 1.98(a)(3)(i) because it does not include a concise explanation of the relevance (for NPL cite #11 to T.H. Marnay), as it is presently understood by the individual designated in 37 CFR 1.56(c) most knowledgeable about the content of the information, of each reference listed that is not in the English language. It has been placed in the application file, but the information referred to therein has not been considered.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-3 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 18-20 of copending Application No. 18/236,367 (hereinafter ‘367).
Regarding Claim 1, ‘367 discloses a method of restoring spinal alignment and range of motion comprises the steps of (preamble, claim 1):
completing a preoperative imaging protocol to acquire at least one image using one or more imaging techniques to create one or more preoperative measurements (claim 1 “completing a preoperative imaging protocol…” step);
selecting a surgical approach (claim 1, “selecting a surgical approach” step);
positioning the patient properly (see claim 1, while not explicitly disclosed, one of ordinary skill in the art recognizes that the patient would need to be positioned properly in order to acquire the desired images, as well as placing the patient properly to perform a procedure);
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 (claim 1, “completing an operative imaging protocol..” step);
accessing at least one localized spine segment in a spine region (claim 1, “accessing..” step);
selecting a spinal implant size on at least one side (claim 1 “selecting a spinal implant size..” step);
preparing a caudal vertebral body on the at least one side (claim 18 “preparing a caudal..” step);
preparing a cranial vertebral body on the at least one side (claim 18, “preparing a cranial..” step);
completing at least one caudal keel channel on the caudal vertebral body on the at least one side (claim 18 “completing at least one caudal keel channel..” step);
completing at least one cranial keel channel on the cranial vertebral body and verifying alignment on the at least one side; and implanting the at least one selected spinal implant into the at least one side (claim 18 “completing at least one cranial keel channel..” step).
‘367 also discloses the limitations of Claim 2 (see claim 19) and Claim 3 (see claim 20).
This is a provisional nonstatutory double patenting rejection.
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 4-5, 7-8, 11, 12 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 4 recites the limitation "the angle of correction" in line 2. There is insufficient antecedent basis for this limitation in the claim. The examiner will treat with art as best understood.
Claim 4 recites the limitation "the angle of correction" in line 3. There is insufficient antecedent basis for this limitation in the claim. The examiner will treat with art as best understood.
Claim 7 recites the limitation "the caudal resected surface" in line 3. There is insufficient antecedent basis for this limitation in the claim. The examiner will treat with art as best understood.
Claim 11 recites the limitation "the caudal vertical axis" in line 3. There is insufficient antecedent basis for this limitation in the claim. The examiner will treat with art as best understood.
Claim 12 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 or dynamic.
Claim 16 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.
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 1-18, 20 are rejected under 35 U.S.C. 103 as being unpatentable over Carls US 2008/0300685 in 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 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 one the least one side of the spine segment, likewise see paragraph 60 where patients anatomy is also considered to “create desired lordosis or kyphosis”);
preparing a caudal vertebral body on the at least one side (paragraph 64, the disc space and upper/cranial “V1” and lower/caudal vertebra “V2” are prepared);
preparing a cranial vertebral body on the at least one side (paragraph 64, the disc space and upper/cranial “V1” and lower/caudal vertebra “V2” are prepared);
completing at least one caudal keel channel on the caudal vertebral body on the at least one side (paragraph 64, Fig 1-2, Fig below in Carls where a keel channel is made to match keel #58 on a lower end of the implant);
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 Fig below in Carls where a keel channel is made to match keel #52 on an upper end of the implant, verification would be needed to ensure the keel #32 matches up with the keel channel); and
implanting the at least one selected spinal implant into the at least one side (paragraph 65).
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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 2, 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 in Carls 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 in Carls).
Regarding Claim 3, 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 in Carls), the path trajectory follows along, matches or substantially matches the transverse pedicle angle (paragraph 56, Fig 3 in Carls 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).
Regarding Claim 4, Carls as modified discloses the resected surface comprises a sagittal angle (Fig 13 in Carls where the resected surface is angled along a sagittal plane), the angle matches or substantially matches the angle of correction (paragraph 60 in Carls where patients anatomy and placement of the implant #30 and thus the sagittal angle of the resected surface is considered to “create desired lordosis or kyphosis” or angle of correction) from the one or more preoperative measurements (with the modification in view of Pacheco as discussed above in claim 1, where in order to create the desired angle of correction, lordosis or kyphosis, preoperative measurements would be taken to take into account implant dimension and placement).
Regarding Claim 5, 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 in Carls) and a sagittal angle (Fig 13 in Carls where the resected surface is angled along a sagittal plane), the path trajectory follows along, matches or substantially matches the transverse pedicle angle (paragraph 56, Fig 3 in Carls 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) and the sagittal angle matches or substantially matches the angle of correction (paragraph 60 in Carls where patients anatomy and placement of the implant #30 and thus the sagittal angle of the resected surface is considered to “create desired lordosis or kyphosis” or angle of correction) from the one or more preoperative measurements (with the modification in view of Pacheco as discussed above in claim 1, where in order to create the desired angle of correction, lordosis or kyphosis, preoperative measurements would be taken to take into account implant dimension and placement).
Regarding Claim 6, Carls as modified discloses wherein the step of preparing the cranial vertebral body on the at least one side comprises the step of preparing a portion of an endplate on the at least one side of the cranial vertebral body to create a cranial resected or cranial prepared surface (paragraph 64 in Carls as discussed above in claim 1).
Regarding Claim 7, Carls as modified discloses the step of preparing the cranial vertebral body on the at least one side further comprises the step of confirming alignment of the cranial resected or prepared surface (paragraph 64 in Carls as discussed above in claim 1) relative to the 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 in Carls 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 in Carls) on the at least one side (one would confirm the alignment of the cranial prepared surface with the caudal resected surface in order to accommodate upper and lower portions of implant #30).
Regarding Claim 8, Carls as modified discloses the step of confirming the alignment comprises confirming parallel or substantially parallel alignment of the cranial prepared or resected surface relative to the caudal resected surface (as seen in Fig 5 of Carls where the cranial prepared or resected surface the caudal resected surface line up with upper and lower portions of implant #30, the upper and lower portions of implant #30 are substantially parallel to each other).
Regarding Claim 9, Carls as modified discloses the step of completing at least one caudal keel channel on the caudal vertebral body on the at least one side comprises the step of creating at least one caudal keel channel extending below the caudal resected surface on the at least one side (paragraph 64 in Carls as discussed above in claim 1, the keel channels would be opposing to each other to accommodate respective keels #52, #58 of the implant #30), the at least one caudal keel channel including a caudal vertical axis (Fig 3 in Carls, the caudal keel channel would include a caudal vertical axis aligned with the height of keel #58).
Regarding Claim 10, Carls as modified discloses the step of completing at least one cranial keel channel on the cranial vertebral body on the at least one side comprise the step of creating at least one cranial keel channel above the cranial resected or prepared surface of the cranial vertebral body that aligns with the at least one caudal keel channel (paragraph 64 in Carls as discussed above in claim 1, the keel channels would be opposing to each other to accommodate respective keels #52, #58 of the implant #30), the at least one cranial keel channel including a cranial vertical axis (Fig 3 in Carls, the cranial keel channel would include a cranial vertical axis aligned with the height of keel #52).
Regarding Claim 11, Carls as modified discloses the alignment comprises the caudal vertical axis of the at least one caudal keel channel and the cranial vertical axis of the at least one cranial keel channel is aligned co-linearly (as discussed in claims 9-10 above, the vertical axes is aligned with the height of their respective keels #52, #58 where the keels are directly opposite each other and as seen in Fig 2-3, 13 the vertical axes would be aligned co-linearly ).
Regarding Claim 12, Carls as modified discloses the preoperative imaging protocol comprises one or more static and dynamic patient positions (paragraph 39 in Pacheco 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 13, Carls as modified discloses the one or more preoperative measurements comprises an angle of correction (see rejection for claim 1 above and see also paragraph 60 in Carls a goal is to have an angle or correction to “create desired lordosis or kyphosis”) and/or center of rotation.
Regarding Claim 14, Carls as modified discloses the angle of correction comprises a sagittal angle and/or a coronal angle (see rejection for claim 13 above where an angle of correction to “create desired lordosis or kyphosis” would involve at least a sagittal angle)
Regarding Claim 15, Carls as modified discloses the one or more imaging techniques comprises a radiograph, an MRI, a CT scan, an ultrasound and/or any combination thereof (paragraph 39 in Pacheco).
Regarding Claim 16, Carls as modified discloses the surgical approach comprises a TLIF and/or a PLIF (paragraph 63 in Carls, can be TLIF or PLIF).
Regarding Claim 17, Carls as modified discloses the one or more operative measurements comprise the same measurements as the one or more preoperative measurements (paragraph 53 in Pacheco where the intraoperative images are superimposed on the preoperative images to ensure the two are equal).
Regarding Claim 18, Carls as modified discloses the confirmation comprises matching or substantially matching the one or more operative measurements relative to the one or more preoperative measurements (paragraph 53 in Pacheco where the intraoperative images are superimposed on the preoperative images to ensure the two are equal).
Regarding Claim 20, Carls as modified discloses the step of selecting a spinal implant size comprises the steps determining 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 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).
Claims 19 is 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.
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.
Conclusion
See PTO-892 for art of cited interest, Cite B and C show implants being implanted within at least one side of the disc space. Examiner notes references cited by applicant which also show implants located on one side of the disc space, Peterman US 2018/0228619 and US 2021/0322178.
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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