DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Election/Restrictions
Applicant’s election without traverse of Group I, Species 2, shown in Figs. 11-14 in the reply filed on 08/13/2025 is acknowledged. It is noted that Fig. 10 is directed to a non-elected embodiment. 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. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of the first paragraph of 35 U.S.C. 112. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed applications, Application No. 15/712,046, filed on 09/21/2017, now Pat. No. 10,631,995, fail to provide adequate support or enablement in the manner provided by the first paragraph of 35 U.S.C. 112 for claims 1-9 and 21-25 of this application. It is noted that the claimed subject matter has been presented for the first time in this application and is not supported in the prior-filed application. Independent claim 1 includes the method step of “removing at least a second portion of the superior endplate of the first vertebra to create a second resected surface of the superior endplate, the first resected surface being asymmetrical to the second resected surface.”
Accordingly, the effective filing date for the claimed subject matter in the current application is 04/09/2018 and will be treated as such for examination purposes.
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 21, 23 and 25 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.
The term “substantially” in claims 21, 23 and 25 is a relative term which renders the claims indefinite. The term “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
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, 22 and 24 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 Gordon et al. (U.S. 2006/0241769 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because the differences amount to minor changes in the arrangement and phraseology of the claim limitations. The claims of both the issued patent and the present application are directed to substantially the same invention. Claims 1, 22 and 24 of the application recite that the surgical approach is posterior, and that the resected surfaces are asymmetrical.
Gordon et al. teach a posterior surgical approach to the spine that includes asymmetric resection of the vertebral bodies. In par. 0151 and 0156 Gordon et al. disclose the removal of osteophytes and tissue. Tissue and osteophytes differ from each side of the vertebral body and therefore the resection on each side of the vertebral body will be tailored for receipt of the specific bimodal device (see par. 0151 and 0062) to be implanted. A bimodal approach aims to provide a more physiologically appropriate solution that balances the need for stability with the preservation of natural spinal motion, potentially reducing adjacent segment disease that can occur with symmetrical resection without regard to the specific patient’s anatomy.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the method of the patent to include a posterior approach to the spine that includes asymmetrical resection, the concept of which is disclosed by Gordon et al., in order to access the disc space in a manner that avoids nerve damage, and addresses the specific needs of the patient by tailoring resection to receive the implant and provide balance.
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 pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim(s) 1-9 and 21-25 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Gordon et al. (U.S. 2006/0241769 A1).
Concerning claim 1, Gordon et al. disclose a method of altering a medial/lateral tilt of a human spine, comprising: accessing an intervertebral disc space between a first vertebra and a second vertebra
via a first posterior surgical approach and a second posterior surgical approach (see par. 0151), removing at least a portion of an intervertebral disc within the intervertebral disc space via at least one of the first and second posterior surgical approaches (see par. 0151, lines 10-12), removing at least a first portion of a superior endplate of the first vertebra to create a first resected surface of the superior endplate (see par. 0156, lines 12-14), removing at least a second portion of the superior endplate of the first vertebra to create a second resected surface of the superior endplate (see par. 0156, lines 12-14), the first resected surface being asymmetrical to the second resected surface (it is noted that osteophytes and tissue will be different on each side of the vertebrae and therefore the resection on each side for receipt of bimodal devices (see par. 0151 and 0062) would be asymmetrical). A bimodal approach aims to provide a more physiologically appropriate solution that balances the need for stability with the preservation of natural spinal motion, potentially reducing adjacent segment disease that can occur with symmetrical resection. Gordon further discloses installing a first dynamic interbody device and a second dynamic interbody device between the first vertebra and the second vertebra (see Fig. 1, elements 50’ and 50”), the first dynamic interbody device (50’) being positioned on the first resected surface and the second dynamic interbody device (50”) being positioned on the second resected surface, wherein at least one of the first and second dynamic interbody devices is configured to facilitate movement of the first vertebra relative to the second vertebra, and wherein a majority of the first dynamic interbody device is configured to be disposed on a first side of a sagittal plane of the human spine and wherein a majority of the second dynamic interbody device is configured to be
disposed on a second side of the sagittal plane of the human spine (see Fig. 1); the first dynamic interbody device including a superior component (see Figs. 6 and 7, element 60) and an inferior
component (see Figs. 3-5, elements 56 and 58), the superior component including a superior flexion limiter (see Fig. 7, element 102 and par. 0093) positioned at an anterior end of the superior component and a superior extension limiter (see Fig. 7, element 100 and par. 0093) positioned at a posterior end of the superior component, the inferior component including an inferior flexion limiter (see Fig. 2 below) positioned at an anterior end of the inferior component and an inferior extension limiter (see fig. 5, element 88) positioned proximate to a midpoint of the inferior component.
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Concerning claim 2, wherein the superior component includes a superior articulating surface (see Fig. 7, element 106) positioned between the superior flexion limiter (102) and the superior extension limiter (100).
Concerning claim 3, wherein the inferior component includes an inferior articulating surface (see Fig. 5, elements 90) positioned between the inferior flexion limiter and the inferior extension limiter.
Concerning claim 4, wherein the first dynamic interbody device has a first longitudinal axis and the second dynamic interbody device has a second longitudinal axis, and the first longitudinal axis is not parallel to the second longitudinal axis when the first and second dynamic interbody devices are installed between the first vertebra and the second vertebra. See par. 0151 which specifies that the implants may be bimodal devices. Accordingly, the method steps of implanting a first dynamic interbody device on the first side and implanting a second dynamic device on the contralateral side of the patient’s vertebral space (see pars. 0153 and 1054) would inherently lead to non-parallel orientations between the longitudinal axes of the devices. Removal of osteophytes and tissue would create asymmetry between sides of the vertebral body. Furthermore, the intervertebral space is typically not even on both sides in most people due to spinal curvature, scoliosis, degenerative changes, developmental variations, and postural habits. When surgeons implant intervertebral devices they must account for these asymmetries. Bimodal devices come in asymmetric or adjustable designs to accommodate the patient’s specific anatomy and would be implanted in an orientation, i.e., non-parallel to best support the spine.
Concerning claim 5, wherein the inferior component of the first dynamic interbody device is fixed to the second vertebrae by a fastener (see par. 0079 – “a bone fastener of the posterior stabilization system may be positioned in the slot 76”).
Concerning claim 6, wherein the fastener is a bone screw (see par. 0079).
Concerning claim 7, wherein the fastener extends through an opening (see Fig. 3, element 76) in the inferior component positioned proximate to a posterior end of the inferior component.
Concerning claim 8, wherein the inferior component includes an inferior bone facing surface having a keel (see Fig. 3, element 62) extending downward therefrom.
Concerning claim 9, wherein the superior component of the first dynamic interbody device is not fixed to the second vertebrae by a bone screw fastener (see Fig. 26).
Concerning claim 21, as best understood, wherein the first and second dynamic interbody devices are identical in size and shape (see par. 0062 – 50’ and 50” – may be mirror images).
Concerning claim 22, Gordon et al. disclose a method of altering an alignment of a human spine, comprising: accessing an intervertebral disc space between a first vertebra and a second vertebra
via at least one posterior surgical approach (see par. 0151), removing at least a portion of an intervertebral disc within the intervertebral disc space (see par. 0151, lines 10-12), removing at least a first portion of a superior endplate of the first vertebra to create a first resected surface of the superior endplate and removing at least a second portion of the superior endplate of the first vertebra to create a second resected surface of the superior endplate (see par. 0156), the first resected surface being asymmetrical to the second resected surface (see rejection of claim 1), installing a first dynamic interbody device and a second dynamic interbody device between the first vertebra and the second vertebra (see Fig. 1), the first dynamic interbody device positioned on the first resected surface and the second dynamic interbody device positioned on the second resected surface, wherein at least one of the first and second dynamic interbody devices is configured to facilitate movement of the first vertebra relative to the second vertebra, and wherein a majority of the first dynamic interbody device is configured to be disposed on a first side of a sagittal plane of the human spine and wherein a majority of the second dynamic interbody device is configured to be disposed on a second side of the sagittal plane of the human spine, wherein the first and second dynamic interbody devices are not in contact with each other when installed between the first vertebra and the second vertebra (see Fig. 30).
Concerning claim 23, wherein the first and second dynamic interbody devices are substantially identical in size and shape (see par. 0062 – 50’ and 50” – may be mirror images).
Concerning claim 24, Gordon et al. disclose a method of altering an alignment of a human spine, comprising: accessing an intervertebral disc space between a first vertebra and a second vertebra
via at least one posterior surgical approach (see par. 0151), removing at least a portion of an intervertebral disc within the intervertebral disc space (see par. 0151, lines 10-12), removing at least a first portion of a superior endplate of the first vertebra to create a first resected surface of the superior endplate and removing at least a second portion of the superior endplate of the first vertebra to create a second resected surface of the superior endplate (see par. 0156, lines 12-14), the first resected surface being asymmetrical to the second resected surface (it is noted that osteophytes and tissue will be different on each side of the vertebrae and therefore the resection on each side for receipt of bimodal devices (see par. 0151 and 0062) would be asymmetrical). A bimodal approach aims to provide a more physiologically appropriate solution that balances the need for stability with the preservation of natural spinal motion, potentially reducing adjacent segment disease that can occur with symmetrical resection. Gordon et al. further disclose installing a first dynamic interbody device and a second dynamic interbody device between the first vertebra and the second vertebra (see Fig. 1, elements 50’ and 50”), the first dynamic interbody device positioned on the first resected surface and the second dynamic interbody device positioned on the second resected surface, wherein at least one of the first and second dynamic interbody devices is configured to facilitate movement of the first vertebra relative to the second vertebra, and wherein a majority of the first dynamic interbody device is configured to be disposed on a first side of a sagittal plane of the human spine and wherein a majority of the second dynamic
interbody device is configured to be disposed on a second side of the sagittal plane of the human spine,
wherein the first dynamic interbody device includes a first articulating ball and socket joint (see Fig. 8, elements 110 and 108) and the second dynamic interbody device includes a second articulating ball and socket joint, and the first and second articulating ball and socket joints are spaced apart from each
other when installed between the first vertebra and the second vertebra (see Fig. 1, elements 50’ and 50”).
Concerning claim 25, as best understood, wherein the first and second dynamic interbody devices are identical in size and shape (see par. 0062 – 50’ and 50” – may be mirror images).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The art includes two separate intervertebral components that are implanted within a single disc space and positioned side by side in a non-parallel manner.
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