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 .
This Office action is in response to the amendment filed 12/15/2025. Claims 1-5, 7-11, and 14-20 remain pending.
Election/Restrictions
Applicant elected Species 2 in the reply filed on 06/23/2025.
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 1-5, 7-11 and 14-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10,821,003 B2 in view of Yu et al. (U.S. 2008/0027547 A1).
Claims 1-20 of the patent disclose the invention of claims 1-5, 7-11 and 14-20 of the application except for explicitly disclose the implantation step of a second spinal prosthetic implant, and the preparing of the endplates for implant reception, wherein a first resected plane at a first orientation is different than a second resected plant at a second orientation..
Yu et al. teach a method for creating a desired lordosis or kyphosis between an upper vertebra and a lower vertebrae comprising the method steps of implanting first and second spinal prosthetic implants, and preparing the endplates for implant reception (see Fig. 4 and par. 0056) in the same field of endeavor.
It would have been obvious to one having ordinary skill in the art to include two separate implant components since it has been held that constructing a formerly integral structure in various elements involves only routine skill in the art. Nerwin v. Erlichman, 168 USPQ 177, 179. Furthermore, two smaller sized implants can more accurately address the patient’s specific spinal anatomy and can be tailored to have different heights should an intervertebral space be worn to require more height on one particular side. Additionally, the preparation of endplates for receipt of the implants is a well-known concept in the art.
Regarding the orientation of the resected plane, the specific resection plane is determined by the operating surgeon to create the desired lordosis or kyphosis. This would inherently result in differing resection planes.
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) 1-5 and 7-10 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. disclose a surgical method for creating a desired lordosis or kyphosis between an upper vertebra (V1) and a lower vertebrae (V2), comprising the steps of: removing at least a portion of a natural intervertebral disc (see par. 0064, lines 1-4 “some or all of the affected disc D1 and surrounding tissue may be removed”) from between the upper and lower vertebrae to create a disc space in a targeted spinal region; selecting a proper size of a spinal prosthetic implant (see Fig. 13 and note that the implant is sized to fit within the intervertebral space; and see par. 0060); preparing at least a portion of a first endplate of the upper vertebrae to create a first resected plane at a first orientation (see par. 0064, lines 4-13 “some or all of the surrounding tissue may be removed...the superior endplate 24 of the vertebra V2 may be milled, rasped, or otherwise resected to match the profile of the outer contact surface 50 of the lower joint component 34…the preparation of the endplate 24 of vertebra V2 may result in surface contours that match corresponding features on the outer contact surface 50” – “The inferior endplate 18 of the vertebra V1 may be similarly prepared to receive the upper joint component 32”); preparing at least a portion of the second endplate of the lower vertebrae to create a second resected plane at a second orientation (see par. 0064, lines 13-16 “some or all of the surrounding tissue may be removed...the superior endplate 24 of the vertebra V2 may be milled, rasped, or otherwise resected to match the profile of the outer contact surface 50 of the lower joint component 34…the preparation of the endplate 24 of vertebra V2 may result in surface contours that match corresponding features on the outer contact surface 50”), wherein the first resected plane at the first orientation (see Fig. 3 below) is different than the second resected plane at the second orientation (see Fig. 3 below); and implanting the spinal prosthetic implant within the disc space onto the prepared upper endplate of the upper vertebrae and the prepared lower endplate of the lower vertebrae (see Fig. 13).
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“According to at least one of these approaches, an incision, such as a midline incision, may be made in the patient's back and some or all of the affected disc D1 and surrounding tissue may be removed via the foramina. The superior endplate 24 of the vertebra V2 may be milled, rasped, or otherwise resected to match the profile of the outer contact surface 50 of the lower joint component 34 to normalize stress distributions on the endplate 24, and/or to provide initial fixation prior to bone ingrowth. The preparation of the endplate 24 of vertebra V2 may result in a flattened surface or in surface contours such as pockets, grooves, or other contours that may match corresponding features on the outer contact surface 50. The inferior endplate 18 of the vertebra V1 may be similarly prepared to receive the upper joint component 32 to the extent allowed by the exiting nerve root and the dorsal root ganglia. Depending on whether the facet joint 26 is being replaced, the natural facet joint and the corresponding articular processes 16, 22 may be trimmed to make room for the bridge component 62.”
“In still other alternative embodiments, the heights of the upper and lower joint components may increase or decrease along the length of the component to create a desired lordosis or kyphosis. The ability to modify the resulting angle between the upper and lower contact surfaces may allow the surgeon to address variations among patient anatomies or between levels of the vertebral column, such as at the lumbosacral joint (L5-S1). Allowing the surgeon to vary the height, angulation, and performance of the prosthetic device based on the vertebral level or the patient's anatomy may ensure a better fit and a better prognosis for the patient.”
As noted above, specifically in par. 0060, the first resected plane has a first orientation that is different than the second resected plane at the second orientation to create a desired lordosis or kyphosis. Angled end plate preparation is the key to creating kyphosis or lordosis. Asymmetric distraction of the disc space (more posterior for lordosis, more anterior for kyphosis) allows angled rasps and trials to cut the bony end plate at a calculated angle. It is inherent that the first resected plane would be different and asymmetrical to the second resected plane.
Concerning claim 2, wherein the step of selecting the proper size of the spinal prosthetic implant comprises the step of tensioning the soft tissues within the disc space (see par. 0060).
Concerning claim 3, wherein the step of selecting the proper size of the spinal prosthetic implant comprises the steps of: tensioning the soft tissues within the disc space (see par. 0060, lines 1-10); and
trialing at least one dimension of the spinal prosthetic implant using one or more trialing tools (“adding material to increase the overall height of the lower component” – see par. 0060, lines 5-6) to maintain tensioning of the soft tissues within the disc space.
Concerning claim 4, wherein the at least one dimension comprises at least one height dimension (see par. 0060, lines 5-6) or at least one length dimension.
Concerning claim 5, wherein the at least one dimension comprises at least one height dimension (see par. 0060, lines 5-6) and at least one length dimension (see par. 0060, lines 10-13).
Concerning claim 7, wherein the second resected plane (see Fig. 13 above) at the second orientation comprises an angled orientation (see par. 0060).
Concerning claim 8, wherein the first resected plane of the first orientation comprises a planar orientation (see Fig. 13 below).
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Concerning claim 9, wherein the second resected plane at a second orientation is below a native anatomical plane of the second endplate (see Fig. 13 above).
Concerning claim 10, wherein the spinal prosthetic implant comprises an upper joint component and a lower joint component, the upper joint component comprises an upper articulation surface, the upper articulation surface includes a concave shape (see Fig. 13 above and par. 0048), the lower joint component comprises a lower articulation surface, the lower articulation surface includes a convex shape (see Fig. 13 above and par. 0048), the upper articulation surface of the upper joint component engages with the lower articulation surface of the lower joint component to create a ball-and-socket joint (see Figs. 8-9) that permits motion between the upper and lower vertebrae.
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) 11, 14-16, 19 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Carls et al. (U.S. 2008/0300685 A1) in view of Yu et al. (U.S. 2008/0027547 A1).
Concerning claims 11, 19 and 20, Carls et al. disclose a surgical method for creating a desired lordosis or kyphosis between an upper vertebra and a lower vertebrae (see par. 0060, lines 12-13), comprising the steps of: removing at least a portion of a natural intervertebral disc from between the upper and lower vertebrae to create a disc space in a targeted spinal region (see par. 0064, lines 1-4); removing at least a first portion of an upper endplate (see par. 0064, lines 4-13) and at least a portion of a first pedicle of the lower vertebrae to create a first resected plane at a first orientation (see Fig. 13 and par. 0064, lines 16-20); implanting a first spinal prosthetic implant within the disc space onto the first resected plane to obtain a first desired tension of a first annulus portion (see par. 0060 and see Fig. 13), wherein the first orientation and the second orientation are asymmetrical.
However, Carls et al. do not disclose the method steps of removing at least a second portion of the upper endplate and at least a portion of a second pedicle of the lower vertebrae to create a second resected plane at a second orientation; implanting a second spinal prosthetic implant within the disc space onto the second resected plane to obtain a second desired tension of a second annulus portion, the second spinal prosthetic implant spaced apart from the first spinal prosthetic implant; wherein the first and second desired tensions are balanced to enable an articulation of the upper vertebrae relative to the lower vertebrae between a first flexed position and a second extended position.
Yu et al. disclose a method for creating a desired lordosis or kyphosis between an upper vertebra and a lower vertebrae comprising the steps of utilizing two separate implant components.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify Carl’s method to include implanting two separate implant components, the concept of which is disclosed by Yu et al., since it has been held that constructing a formerly integral structure in various elements involves only routine skill in the art. Nerwin v. Erlichman, 168 USPQ 177, 179. Furthermore, two smaller sized implants can more accurately address the patient’s specific spinal anatomy and can be tailored to have different heights should an intervertebral space be worn to require more height on one particular side.
Concerning claims 14-15, the modification of Carls in view of Yu et al. would lead one of ordinary skill in the art before the effective filing date of the claimed invention to decide whether to resect the first and second planes in a symmetrical or asymmetrical orientation based on the specific anatomy of the patient, any previous injury, and a desired lordosis or kyphosis. Proper spinal alignment is decided on a case by case basis and involves resection planes and implant structure assessment before, during and after placement. Specifically, regarding the recitation in claim 14, it is noted that an operating surgeon would select the first orientation and second orientation to induce a sagittal correction between the upper and lower vertebrae if the patient’s specific anatomy required as such. Likewise, an operating surgeon would select the first orientation and second orientation to induce a combined coronal and sagittal correction between the upper and lower vertebrae if the patient’s anatomy required as such for proper spinal alignment.
Concerning claim 16, it is noted that Carls et al. disclose the method step of using a rasp on the endplate (see par. 0064), and the step of removing all or a portion of the pedicle (see par. 0055). Carls et al. do not explicitly disclose that the pedicle and endplate are removed concurrently. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to concurrently remove the endplate and pedicle with a rasp if the patient’s anatomy and operating surgeon found that concurrent rasping to benefit the patient and achieve the desired tissue removal.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Carls et al. (U.S. 2008/0300685 A1) in view of Yu et al. (U.S. 2008/0027547 A1), as applied to claim 16 above, further in view of Gordon et al. (U.S. 2006/0241769 A1).
Carls et al. in view of Yu et al. disclose the invention substantially as described above. However, Carls et al. in view of Yu et al. do not explicitly disclose that the surgical rasp is attached to a surgical guidance system.
Gordon et al. teach the use of a surgical guidance system (see Fig. 29) in the same field of endeavor for the purpose of performing a discectomy.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to use a surgical guidance system, the concept of which is disclosed by Yu et al., in order to ensure the rasp is properly positioned within the disc space for tissue removal. The guidance system provide direction on tool location which can’t be viewed during minimally invasive procedures.
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Carls et al. (U.S. 2008/0300685 A1) in view of Yu et al. (U.S. 2008/0027547 A1), as applied to claim 16 above, further in view of Lang et al. (U.S. 8,337,507 B2).
Carls et al. in view of Yu et al. disclose the invention substantially as described above. However, Carls et al. in view of Yu et al. do not explicitly disclose that the surgical rasp is attached to a surgical robot.
Lang et al. teach the use of a robotic device (see col. 31, lines 7-9) in the same field of endeavor for the purpose of preparing implant sites.
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 robotic device to operate the surgical rasp, the concept of which is disclosed by Lang et al., in order to assist in proper tissue removal. The robot can utilize electronic images thereby enhancing the accuracy of removal during a minimally invasive procedure.
Response to Arguments
Applicant's arguments filed 12/15/2025 have been fully considered but they are not persuasive. In response to Applicant’s argument that “Carls is completely silent as to any angles of resection or endplate preparation,” it is noted that Carls is very specific about angles of resection and endplate preparation. For example, in par. 0064 Carls discloses “According to at least one of these approaches, an incision, such as a midline incision, may be made in the patient's back and some or all of the affected disc D1 and surrounding tissue may be removed via the foramina. The superior endplate 24 of the vertebra V2 may be milled, rasped, or otherwise resected to match the profile of the outer contact surface 50 of the lower joint component 34 to normalize stress distributions on the endplate 24, and/or to provide initial fixation prior to bone ingrowth. The preparation of the endplate 24 of vertebra V2 may result in a flattened surface or in surface contours such as pockets, grooves, or other contours that may match corresponding features on the outer contact surface 50. The inferior endplate 18 of the vertebra V1 may be similarly prepared to receive the upper joint component 32 to the extent allowed by the exiting nerve root and the dorsal root ganglia. Depending on whether the facet joint 26 is being replaced, the natural facet joint and the corresponding articular processes 16, 22 may be trimmed to make room for the bridge component 62.” In par. 0060 Carls notes that the implant may be angled to achieve the desired lordosis or kyphosis. With endplate preparation disclosed as matching the implant, the resection plane of the endplate of V1 would inherently be angled and different than the resection plane of V2.
Angled end plate preparation is the key to creating kyphosis or lordosis. Asymmetric distraction of the disc space (more posterior for lordosis, more anterior for kyphosis) allows angled rasps and trials to cut the bony end plate at a calculated angle. It is inherent that the first resected plane would be different and asymmetrical to the second resected plane.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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