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 the following species in the reply filed on November 17, 2025 is acknowledged:
Preoperative Method
Fig. 1
Preoperative Imaging Protocol
Fig. 2A
Intraoperative Procedure
Fig. 3B
Accessing the Localized Spine Segment
Fig. 5
Completing a Decompression Technique
Fig. 6B
Selecting a Proper Spinal Implant Size
Fig. 7B
Determining Proper Spinal Implant Height
Fig. 8D
Determining Proper Implant Height
Fig. 12D
Preparing Intervertebral Space
Fig. 15C
Preparing the Caudal Vertebral Body
Fig. 16D
Preparing the Cranial Vertebral Body
Fig. 18B
Completing a Keel Channel on the Caudal Vertebral Body
Fig. 20C
Completing a Keel Channel on the Cranial Vertebral Body
Fig. 21D
Implanting a Spinal Implant
Fig. 26C
Removing a Spinal Implant
Fig. 32
Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claim Objections
Claim 1 is objected to because of the following informalities: the claim ends with a semicolon instead of a period. 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 1-20 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 1 recites the limitation "a first side" in line 8, line 10, and line 14. However, claim 1 already recites a first side (line 3). Thus, it is unclear whether “a first side” in lines 8, 10, and 14 is intended to refer to an additional first side or the first side recited in line 3. For examination purposes, the Examiner is interpreting “a first side” in lines 8, 10, and 14 as “the first side.” Claims 2-20 are rejected because they depend from claim 1.
Claims 1-20 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 1 recites the limitation "a second side" in line 9, line 11, line 12, and line 18. However, claim 1 already recites a second side (line 4). Thus, it is unclear whether “a second side” in lines 9, 11, 12, and 18 is intended to refer to an additional second side or the second side recited in line 4. For examination purposes, the Examiner is interpreting “a second side” in lines 9, 11, 12, and 18 as “the second side.” Claims 2-20 are rejected because they depend from claim 1.
Claim 7 is 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 7 recites the limitation "the one or more imaging techniques" in line 1. There is insufficient antecedent basis for this limitation in the claim as claim 1 recites “completing an operative imaging protocol…using one technique.” For examination purposes, the Examiner is interpreting claim 7 as reciting “the imaging technique.”
Claim 7 is 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. The use of “and/or any combination thereof” is indefinite because claim 1 recites “completing an operative imaging protocol…using one technique.” For examination purposes, the Examiner is interpreting claim 7 as reciting “a radiograph, an MRI, a CT scan, or an ultrasound.”
Claim 11 is 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. The use of “and/or any combination thereof” is indefinite because the scope of “and any combination thereof” is unclear. For examination purposes, the Examiner is interpreting claim 11 as reciting “or any combination thereof.”
Claim 13 is 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. The use of “at least one or more” is indefinite because “at least one” and “one or more” have the same scope. Thus, the scope of “at least one or more” is unclear. For examination purposes, the Examiner is interpreting claim 13 as reciting “one or more localized spine segments.”
Claims 14 and 16-18 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 14 recites the limitation "the step of selecting a first spinal implant size" in line 1. There is insufficient antecedent basis for this limitation in the claim as claim 1 recites “selecting a spinal implant size on a first side.” For examination purposes, the Examiner is interpreting claim 14 as reciting “the step of selecting a spinal implant size on a first side.” Claims 16-18 are rejected because they depend from claim 14.
Claim 15 is 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 15 recites the limitation "the step of selecting a second spinal implant size" in line 1. There is insufficient antecedent basis for this limitation in the claim as claim 1 recites “selecting a spinal implant size on a second side.” For examination purposes, the Examiner is interpreting claim 15 as reciting “the step of selecting a spinal implant size on a second side.”
Claim 16 is 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. The use of “may comprise” is indefinite because it is unclear whether the limitations following the phrase are necessarily included. For examination purposes, the Examiner is interpreting claim 16 as reciting “comprises.”
Claim 16 is 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 16 recites the limitation "the second soft tissue balancing" in line 2. There is insufficient antecedent basis for this limitation in the claim as claim 15 introduces a second soft tissue balancing. Note, however, that claim 16 cannot properly depend from claim 15 because “the first soft tissue balancing” would then not have proper antecedent basis.
Claim 17 is 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 16 recites the limitation "the second spinal implant length" in line 2. There is insufficient antecedent basis for this limitation in the claim as claim 15 introduces a second spinal implant length. Note, however, that claim 17 cannot properly depend from claim 15 because “the first spinal implant length on the first side” would then not have proper antecedent basis.
Claim 18 is 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 18 recites the limitation "the second spinal implant height" in line 2. There is insufficient antecedent basis for this limitation in the claim as claim 15 introduces a second spinal implant height. Note, however, that claim 18 cannot properly depend from claim 15 because “the first spinal implant height on the first side” would then not have proper antecedent basis.
Claim 19 is 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 19 recites the limitation "the step of selecting a first spinal implant size on the first side" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim as claim 1 recites “selecting a spinal implant size on a first side.” For examination purposes, the Examiner is interpreting claim 19 as reciting “the step of selecting a spinal implant size on a first side.”
Claim 20 is 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 20 recites the limitation "the step of selecting a second spinal implant size on the second side" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim as claim 1 recites “selecting a spinal implant size on a second side.” For examination purposes, the Examiner is interpreting claim 20 as reciting “the step of selecting a spinal implant size on a first side.”
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.
Claims 1-13, 19, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pacheco (US 2008/0009945 A1).
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 technique (see para. 0039, which states that CT scan, MRI, or fluoroscopy is used to generate images of the spine region) to create a first one or more preoperative measurements on a first side (see para. 0041, which states that the images are used to determine the height, width, depth, and lordosis angle of a disc space; the measured disc space is being interpreted as the first side as it is located on a first, or cranial side, of a specific vertebra, such as disc space L2/L3 as shown in Fig. 20, which is located on the cranial side of the L3 vertebra; for dependent claims 14-18 only, use disc space L1/L2) and a second one or more preoperative measurements on a second side (see para. 0060, which states that the process is repeated for all disc spaces; the measured disc space is being interpreted as the second side as it is located on a second, or caudal side, of a specific vertebra, such as disc space L3/L4 as shown in Fig. 20, which is located on the caudal side of the L3 vertebra; for dependent claims 14-18 only, use disc space L2/L3);
selecting a surgical approach (see para. 0049, which states that the surgeon can choose an anterior, lateral, or posterior approach for the procedure);
positioning the patient properly (it is inherent that the patient would be positioned in a manner consistent with the chosen approach, and thus the patient would be positioned properly);
completing an operative imaging protocol to acquire at least one image using one technique (see para. 0051, which states that intraoperative fluoroscopy is performed) to create a first one or more operative measurements on a first side (see para. 0053, which refers to measured square areas obtained from the intraoperative fluoroscopy), a second one or more operative measurements on a second side (see para. 0060, which states that the process is repeated for all disc spaces), and confirming the first one or more operative measurements on a first side relative to the first one or more preoperative measurements (see para. 0053, which states that the intraoperative fluoroscopic images are superimposed on the computer generated image created from the preoperative images and that the two are compared to ensure that the measured areas are equal) and the second one or more operative measurements on a second side relative to the second one or more preoperative measurements on a second side (see para. 0060, which states that the process is repeated for all disc spaces);
accessing at least one localized spine segment in a spine region (see para. 0057, which states that the disc space is drilled to the desired depth, and therefore must be accessed);
selecting a spinal implant size on a first side (see para. 0042, which states that the computer identifies an appropriate prosthetic disc volume based on height, width, depth, and lordosis angle);
preparing an intervertebral space within the at least one localized spine segment in the spine region on the first side (see para. 0057, which states that the disc space is drilled to the desired depth; see para. 0058, which states that the disc space is sounded);
implanting the selected spinal implant into the first side (see para. 0059, which states that the prosthetic disc is placed into the disc space);
selecting a spinal implant size on a second side (see para. 0060, which states that the process is repeated for all disc spaces);
preparing an intervertebral space within the at least one localized spine segment in the spine region on the second side (see para. 0060, which states that the process is repeated for all disc spaces); and
implanting the selected spinal implant into the second side (see para. 0060, which states that the process is repeated for all disc spaces).
Claim 2. Pacheco discloses wherein the preoperative imaging protocol comprises one or more static and dynamic patient positions (see para. 0039, which states that CT scan, MRI, or fluoroscopy is used to generate images of the spine region; note that the patient’s position for each image must necessarily be one of static or dynamic because if a position is static, then it is necessarily not dynamic, and if a position is dynamic, then it is necessarily not static).
Claim 3. Pacheco discloses wherein the first one or more preoperative measurements comprises a first angle of correction (see para. 0041, which states that the images are used to determine the lordosis angle of a disc space) and/or first center of rotation and the second one or more preoperative measurements comprises a second angle of correction and/or a second center of rotation (see para. 0060, which states that the process is repeated for all disc spaces).
Claim 4. Pacheco discloses wherein the first angle of correction comprises a first sagittal angle (see para. 0041, which states that the images are used to determine the lordosis angle of a disc space; it is well-known that the lordosis angle is taken in the sagittal plane and thus is a sagittal angle) and/or a first coronal angle and the second angle of correction comprises a second sagittal angle and/or a second coronal angle (see para. 0060, which states that the process is repeated for all disc spaces).
Claim 5. Pacheco discloses wherein the first angle of correction comprises a different angle than the second angle of correction (see Fig. 20, which shows different lordosis values for disc space L2/L3 and disc space L3/L4).
Claim 6. Pacheco discloses wherein the first center of rotation is different than the second center of rotation (note that claim 3 does not require that the measurements include a center of rotation as they can include just the angle of correction).
Claim 7. Pacheco discloses wherein the one or more imaging techniques comprises a radiograph, an MRI, a CT scan, an ultrasound and/or any combination thereof (see para. 0039, which states that CT scan, MRI, or fluoroscopy is used to generate images of the spine region; see para. 0051, which states that intraoperative fluoroscopy is performed).
Claim 8. Pacheco discloses wherein the surgical approach comprises a TLIF and/or a PLIF (see para. 0049, which states that the surgeon can choose a posterior approach for the procedure).
Claim 9. Pacheco discloses wherein the first one or more operative measurements comprise the same measurements as the first one or more preoperative measurements (see para. 0053, which states that the intraoperative fluoroscopic images are superimposed on the computer generated image created from the preoperative images and that the two are compared to ensure that the measured areas are equal) and the second one or more operative measurements comprise the same measurements as the second one or more preoperative measurements (see para. 0060, which states that the process is repeated for all disc spaces).
Claim 10. Pacheco discloses wherein the confirmation comprises matching or substantially matching the first one or more operative measurements relative to the first one or more preoperative measurements (see para. 0053, which states that the intraoperative fluoroscopic images are superimposed on the computer generated image created from the preoperative images and that the two are compared to ensure that the measured areas are equal), and second one or more operative measurements relative to the second one or more preoperative measurements (see para. 0060, which states that the process is repeated for all disc spaces).
Claim 11. Pacheco discloses wherein the spine region comprises a cervical region, a thoracic region, a lumbar region (see Figs. 19 and 20, which identify lumbar disc spaces), a sacral region, and/or any combination thereof.
Claim 12. Pacheco discloses wherein the spine region comprises a lumbar region (see Figs. 19 and 20, which identify lumbar disc spaces).
Claim 13. Pacheco discloses wherein the lumbar region comprises at least one or more localized spine segment, the localized spine segments include L1 to L5 (see Figs. 19 and 20, which identify lumbar disc spaces L1/L2, L2/L3, L3/L4, and L4/L5).
Claim 19. Pacheco discloses wherein the step of selecting a first spinal implant size on the first side comprises the steps of: determining a first spinal implant length on the first side (see para. 0042, which states that the computer identifies an appropriate prosthetic disc volume based on width and depth, which are measurements of length); and determining the first spinal implant height on the first side (see para. 0042, which states that the computer identifies an appropriate prosthetic disc volume based on height).
Claim 20. Pacheco discloses wherein the step of selecting a second spinal implant size on the second side comprises the steps of: determining a second spinal implant length on the second side (see claim 19 above; see para. 0060, which states that the process is repeated for all disc spaces); and determining the second spinal implant height on the second side (see claim 19 above; see para. 0060, which states that the process is repeated for all disc spaces).
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 14-18 are rejected under 35 U.S.C. 103 as being unpatentable over Pacheco (US 2008/0009945 A1) in view of Glenn et al. (US 2004/0059421 A1).
Claim 14. Pacheco discloses wherein the step of selecting a first spinal implant size comprises the steps of: determining a first spinal implant length on the first side (see para. 0042, which states that the computer identifies an appropriate prosthetic disc volume based on width and depth, which are measurements of length); and determining a first spinal implant height on first side (see para. 0042, which states that the computer identifies an appropriate prosthetic disc volume based on height).
Claim 15. Pacheco discloses wherein the step of selecting a second spinal implant size comprises the steps of: determining a second spinal implant length on the second side (see claim 14 above; see para. 0060, which states that the process is repeated for all disc spaces); and determining a second spinal implant height on the second side (see claim 14 above; see para. 0060, which states that the process is repeated for all disc spaces).
Claim 17. Pacheco discloses wherein the first spinal implant length on the first side comprises a different length than the second spinal implant length (see Fig. 20, which shows different widths and depths for disc space L1/L2 and disc space L2/L3).
Claim 18. Pacheco discloses wherein the first spinal implant height on the first side comprises a different height than the second spinal implant height (see Fig. 20, which shows different heights for disc space L1/L2 and disc space L2/L3).
Pacheco fails to disclose completing a first soft tissue balancing on the first side (claim 14), completing a second soft tissue balancing on the second side (claim 15), and the first soft tissue balancing may comprise a different tension and/or balancing than the second soft tissue balancing (claim 16).
Glenn teaches that correcting a spinal deformity by restoring disc space height and restoring lordosis by completing soft tissue balancing via distracting vertebrae and placing adjacent soft tissue structures in tension (see para. 0003, 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 Pacheco by completing a first soft tissue balancing on the first side (claim 14) and completing a second soft tissue balancing on the second side (claim 15), as suggested by Glenn, as such is performed in order to correct a spinal deformity (with regard to claim 15, note that Pacheco discloses repeating the process for all disc spaces in para. 0060). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the first soft tissue balancing may comprise a different tension and/or balancing than the second soft tissue balancing (claim 16), due to the different measurements with respect to the L1/L2 disc space and the L2/L3 disc space (see Fig. 20 of Pacheco).
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 1-4, 7-15, 19, and 20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of copending Application No. 18/236,367 in view of Casey (US 2020/0078180 A1).
The claims correspond as follows:
This Application
Copending App. No. 18/236,367
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The difference between the claims of the present application and those of the copending application is that the claims of the present application include more elements as the identified actions are also performed on a second side in addition to a first side (the steps of completing a preoperative imaging protocol, completing an operative imaging protocol, selecting an implant size, preparing an intervertebral space, and implanting the selected implant in claim 1; the one or more preoperative measurements in claim 3; the angle of correction in claim 4; the one or more operative measurements and the one or more preoperative measurements in claim 9; the one or more operative measurements and the one or more preoperative measurements in claim 10; the step of selecting a second spinal implant size in claim 15; and the step of selecting a second spinal implant size in claim 20). Casey teaches that correcting spinal deformities (see para. 0040) can require performing steps related to imaging, measuring, and implanting at multiple spinal levels, such as L1 through S (see Figs. 7-9 and 11 and paras. 0047-0050, 0055-0056, and 0060), such that the steps are performed on a first side (such as, for example, the cranial side of L3, which would be the disc space located between L2 and L3) and a second side (the caudal side of L3, which would be the disc space located between L3 and L4). 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 the copending application such that the identified actions are also performed on a second side in addition to a first side, as suggested by Casey, as performing the steps at multiple levels may be required to adequately correct a spinal deformity.
This is a provisional nonstatutory double patenting rejection.
Conclusion
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.
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/JULIANNA N HARVEY/Primary Examiner, Art Unit 3773