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 . The prior Office action stated that the application was being examined under the pre-AIA first to invent provisions. That statement was in error. As set forth in the prior Office action and maintained below, each of pending claims 1–9 and 21–25 has an effective filing date of 04/09/2018. Because the application contains claims to a claimed invention having an effective filing date on or after March 16, 2013, it is subject to the first inventor to file provisions of the AIA .
This Office action is in response to the amendment filed 06/16/2026. Claims 1-9 and 21-25 are pending.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 120 is acknowledged. For the reasons set forth in the prior Office action, the disclosure of prior-filed Application No. 15/712,046, now U.S. Patent No. 10,631,995, fails to provide adequate support under 35 U.S.C. 112(a) for “the first resected surface being asymmetrical to the second resected surface,” as recited in each of independent claims 1, 22 and 24. Applicant has not traversed this determination. Accordingly, the effective filing date of claims 1–9 and 21–25 remains 04/09/2018.
Claim Objections
Claims 5 and 9 are objected to because of the following informalities: in each claim, “the second vertebrae” should read “the second vertebra” to conform to the antecedent “a second vertebra” in claim 1. 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 5-7 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 removing portions of “a superior endplate of the first vertebra” to create the first and second resected surfaces on which the dynamic interbody devices are positioned. The superior endplate of the first vertebra faces the disc space only if the first vertebra is the lower of the two vertebrae, so the inferior component of the first dynamic interbody device is seated on the first vertebra. Claim 5, however, recites that “the inferior component of the first dynamic interbody device is fixed to the second vertebrae by a fastener,” i.e., to the upper vertebra. It is unclear how the inferior component, seated on the first (lower) vertebra, is fixed to the second (upper) vertebra. The limitation also appears inconsistent with the disclosure, in which the fastener secures the inferior component to the vertebra on which it is seated. Claims 6 and 7 depend from claim 5 and are rejected for the same reason. For purposes of examination, claim 5 is interpreted as reciting that the inferior component is fixed to the first vertebra.
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 1-9 and 21-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 3 and 20 of U.S. Patent No. 10,821,003 B2 in view of Carls et al. (U.S. 2008/0300685 A1) and Cecchinato et al. (Eur. Spine J. 2015), and, as to claims 22 and 23, further in view of Gordon et al. (U.S. 2006/0241769 A1). Although the claims at issue are not identical, they are not patentably distinct from each other for the reasons below.
Concerning claim 1, claim 3 of the patent (which includes the limitations of patent claims 1 and 2) discloses a surgical method comprising: removing at least a portion of a natural intervertebral disc from between upper and lower vertebrae to create a disc space; milling at least a portion of the natural endplate of the lower vertebra to match a profile of an outer contact surface of a first arthroplasty device, i.e., creating a first resected surface of the superior endplate of the first vertebra; inserting upper and lower portions of the first arthroplasty device into the disc space, the lower portion having an upwardly facing articulation surface that movably engages a downwardly facing articulation surface of the upper portion, i.e., a first dynamic interbody device having a superior component and an inferior component and configured to facilitate movement of the vertebrae; the lower portion including a lower extension limiter positioned posteriorly of the lower articulation surface; and attaching the device to the lower vertebra with a bone fastener.
Claim 3 of the patent discloses the invention of claim 1 of the application except for explicitly disclosing: (a) accessing the disc space via first and second posterior surgical approaches and installing a second dynamic interbody device on a second resected surface, with a majority of each device on opposite sides of the sagittal plane; (b) a superior flexion limiter at an anterior end and a superior extension limiter at a posterior end of the superior component, and an inferior flexion limiter at an anterior end of the inferior component, with the inferior extension limiter proximate to a midpoint of the inferior component; and (c) the first resected surface being asymmetrical to the second resected surface.
Carls discloses (a) and (b) in the same field of endeavor: a second prosthetic device, identical or similar to prosthetic device 30, inserted through a bilaterally opposite TLIF or PLIF approach [par. 0063]; and upper joint component 32 having motion limiters 40 (anterior, flexion) and 42 (posterior, extension), with lower joint component 34 having motion limiters 44 (anterior, flexion) and 46 (extension) positioned between articulation surface 38 and bridge 62 (see Figs. 3, 8 and 9). Cecchinato discloses (c): resecting bone of a vertebra asymmetrically through a posterior approach, with a shorter cut on one side and a higher cut on the opposite side, to correct coronal imbalance (see Abstract; Methods).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to install a second, bilaterally placed device through a second posterior approach, and to provide flexion and extension limiters on both components, as taught by Carls, in order to limit axial rotation through the bilateral pair and to prevent dislocation of each articulating joint at the limits of flexion and extension [Carls par. 0071]. It would also have been obvious to form the first and second resected surfaces asymmetrically, as taught by Cecchinato, in order to correct a coronal (medial/lateral) imbalance of the treated segment.
Claim 20 of the patent (which includes the limitations of patent claim 12) likewise discloses resecting at least a portion of the natural endplate and pedicle of the lower vertebra, a first arthroplasty device whose lower portion includes a lower flexion limiter positioned anteriorly of the lower articulation surface, and attaching the device with a bone fastener. Claim 20 differs from claim 1 of the application by the same items (a) through (c), which would have been obvious for the same reasons.
Regarding claim 22, see claim 1 above. The patent claims and Carls do not explicitly disclose that the first and second devices are not in contact with each other when installed. Gordon discloses two dynamic interbody devices 50’, 50’’ installed in a disc space spaced apart from each other (see Fig. 30) in the same field of endeavor. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to install the bilateral devices spaced apart, as taught by Gordon, in order to use two narrow devices that limit the bone and tissue removed for posterior insertion (see Gordon, par. 0063).
Regarding claim 24, see claim 1 above, and Carls discloses that articulation surfaces 36, 38 form a ball-and-socket style joint [par. 0070], so that the identical bilateral devices provide first and second ball-and-socket joints spaced apart on opposite sides of the sagittal plane.
Regarding claims 2–9, 21, 23 and 25, Carls teaches each added limitation as set forth in the rejection under 35 U.S.C. 103 below, and the claims would have been obvious over the patent claims in view of Carls and Cecchinato (and Gordon, for claim 23) for the same reasons.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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 1-9, 21, 24 and 25 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Carls et al. (U.S. 2008/0300685 A1) in view of Cecchinato et al., “Asymmetrical pedicle subtraction osteotomy in the lumbar spine in combined coronal and sagittal imbalance,” Eur. Spine J., Vol. 24, Suppl. 1 (2015).
Concerning claim 1, Carls discloses a method comprising: accessing an intervertebral disc space between a first vertebra (lower vertebra V2) and a second vertebra (upper vertebra V1) via a first posterior surgical approach and a second posterior surgical approach (a TLIF or PLIF approach for prosthetic device 30, and a bilaterally opposite TLIF or PLIF approach for a second prosthetic device [par. 0063); removing at least a portion of an intervertebral disc (D1) within the disc space via at least one of the approaches (disc removed via the foramina [par. 0047]); removing at least a first portion of a superior endplate (24) of the first vertebra to create a first resected surface (endplate 24 milled, rasped or otherwise resected to match the profile of outer contact surface 50 of lower joint component 34 [par. 0064]); removing at least a second portion of the superior endplate to create a second resected surface (the second device is inserted through the opposite approach “in substantially the same manner,” i.e., onto a correspondingly resected endplate on the second side); installing a first dynamic interbody device (30) and a second dynamic interbody device (the identical or similar second device) between the vertebrae, each positioned on its respective resected surface; wherein at least one device is configured to facilitate movement of the first vertebra relative to the second vertebra (articulation surfaces 36, 38 permit flexion/extension, lateral bending and rotation [par. 0070]); wherein a majority of the first device is disposed on a first side of the sagittal plane and a majority of the second device is disposed on a second side (bilateral pair placed through bilaterally opposite approaches); the first device including a superior component (upper joint component 32) and an inferior component (lower joint component 34 with bridge 62), the superior component including a superior flexion limiter (motion limiter 40) at an anterior end and a superior extension limiter (motion limiter 42) at a posterior end of the superior component (see Figs. 3, 8 and 9), and the inferior component including an inferior flexion limiter (motion limiter 44) at an anterior end of the inferior component and an inferior extension limiter (motion limiter 46) positioned proximate to a midpoint of the inferior component, i.e., between articulation surface 38 and bridge 62 (see Figs. 3 and 9).
Carls does not disclose the first resected surface being asymmetrical to the second resected surface.
Cecchinato teaches, in the same field of endeavor of surgically altering spinal alignment by resecting vertebral bone through a posterior approach, resecting bone from a vertebra asymmetrically, with a shorter cut on the side of the coronal imbalance and a higher cut on the opposite side, so that coronal as well as sagittal alignment is corrected (see Abstract; Methods). Carls itself contemplates adjusting the angulation between the vertebral contact surfaces to address variations in patient anatomy [par. 0060].
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to resect the superior endplate of Carls by different amounts on the first and second sides, such that the first resected surface is asymmetrical to the second resected surface, as taught by Cecchinato, in order to correct a coronal (medial/lateral) imbalance of the treated segment while preserving motion with Carls’ bilateral devices. The modification applies a known technique to a known posterior procedure that already resects the endplate on each side, with predictable results. The resulting method alters the medial/lateral tilt of the spine.
Concerning claim 2, wherein the superior component includes a superior articulating surface (36) positioned between the superior flexion limiter (40) and the superior extension limiter (42) (see Fig. 3).
Concerning claim 3, wherein the inferior component includes an inferior articulating surface (38) positioned between the inferior flexion limiter (44) and the inferior extension limiter (46), the limiters being spaced apart from surface 38 (see Fig. 3; see claim 16 and par. 0050).
Concerning claim 4, wherein the first device has a first longitudinal axis and the second device has a second longitudinal axis that is not parallel to the first when installed. Carls inserts the devices through bilaterally opposite TLIF approaches, which “are typically more oblique” than PLIF approaches [par. 0063], with bridge 62 extending along pedicle 25 of the lower vertebra [par. 0055]. Devices inserted along mirror-image oblique trajectories from opposite sides have converging, i.e., non-parallel, longitudinal axes. To the extent Carls does not expressly disclose this orientation, it would have been obvious to orient each device along its oblique TLIF path and its respective pedicle, yielding non-parallel axes, in order to seat each bridge 62 against its pedicle 25 and distribute load on the lower vertebra.
Concerning claim 5, as best understood, wherein the inferior component (34) is fixed to the vertebra on which it is seated by a fastener (68) (see Fig. 3).
Concerning claim 6, wherein the fastener (68) is a bone screw.
Concerning claim 7, wherein the fastener (68) extends through an opening (connection component 66, a passage at distal end 64 of bridge 62) positioned proximate to a posterior end of the inferior component (see Fig. 3).
Concerning claim 8, wherein the inferior component includes an inferior bone facing surface (outer contact surface 50) having a keel (58) extending downward therefrom (see Fig. 3).
Concerning claim 9, wherein the superior component (32) is not fixed to the second vertebra by a bone screw fastener (upper joint component held in place by a friction fit [par. 0066]).
Concerning claim 21, wherein the first and second dynamic interbody devices are identical in size and shape (second prosthetic device “identical or similar” to device 30 [par. 0069]).
Concerning claim 24, see claim 1 above, Carls in view of Cecchinato also disclose the method of accessing the disc space via at least one posterior surgical approach. Carls further discloses wherein the first device includes a first articulating ball and socket joint (articulation surfaces 36, 38 produce a “ball-and-socket style anterior joint” [par. 0070]) and the identical second device includes a second ball and socket joint, the joints being spaced apart from each other when installed because the devices lie on opposite sides of the sagittal plane.
Concerning claim 25, wherein the first and second devices are identical in size and shape (see claim 21 above).
Claims 22 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Carls et al. (U.S. 2008/0300685 A1) in view of Cecchinato et al. (Eur. Spine J. 2015) and Gordon et al. (U.S. 2006/0241769 A1).
Concerning claim 22, see claim 1 above, and Carls in view of Cecchinato teach accessing the disc space via at least one posterior surgical approach. Carls does not expressly disclose that the first and second devices are not in contact with each other when installed. Gordon teaches two dynamic interbody devices (50’, 50’’) installed in a disc space spaced apart from each other (see Fig. 30) in the same field of endeavor. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to install the bilateral devices of Carls spaced apart, as taught by Gordon, in order to use two narrow devices that limit the bone and tissue removed for posterior insertion (see Gordon, par. 0063).
Concerning claim 23, wherein the first and second devices are identical in size and shape (Carls, second device “identical or similar” to device 30 [par. 0069]).
Response to Arguments
Applicant's arguments filed 06/16/2026 regarding the double patenting rejection have been fully considered but they are not persuasive. Applicant argues that, because embodiments of each claimed invention fall outside the claims of the other, there is no basis for a statutory double patenting rejection (Remarks, p. 7, citing MPEP § 804(II)(A)). It is noted that the claims were rejected on the ground of nonstatutory double patenting, not statutory double patenting. Whether one claim can be infringed without infringing the other is the test for statutory, “same invention” double patenting. The test for nonstatutory double patenting is whether the examined claim is anticipated by, or would have been obvious over, the reference claims. Additional limitations in the reference claims do not avoid the rejection, because a narrower reference claim may anticipate or render obvious a broader examined claim. Additional limitations in the examined claims are addressed in the obviousness analysis.
Applicant also argues that the differences are not “minor changes in the arrangement and phraseology of the claim limitations” (Remarks, p. 6). The new rejection below identifies each difference between the claims and explains why it would have been obvious.
Applicant further argues that Gordon does not teach asymmetric resection surfaces (Remarks, p. 8). This argument is persuasive for the reasons given below. Because the prior nonstatutory double patenting rejection relied on Gordon for that limitation, that rejection is withdrawn. A new nonstatutory double patenting rejection is set forth below.
Applicant’s arguments that Gordon does not disclose “the first resected surface being asymmetrical to the second resected surface” (Remarks, pp. 8–9) have been fully considered and are persuasive. Accordingly, the rejection of claims 1–9 and 21–25 under 35 U.S.C. 102 as anticipated by Gordon is withdrawn.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELLEN HAMMOND whose telephone number is (571)270-3819. The examiner can normally be reached Monday-Friday 8 - 4 PM .
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Eduardo C. Robert, at 571 272-4719. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ELLEN C HAMMOND/Primary Examiner, Art Unit 3773
