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 .
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 - 13 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant's arguments filed 09/11/2025 have been fully considered but they are not persuasive. Regarding claims 14 – 20, Afzal teaches fibers (refs. 207, 210) extending between the endplates. These fibers are considered the artificial annulus fibrosis.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the artificial annulus fibrosis (AF) of claim 14 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
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.
Claim 13 recites “the first NNF” and “the second NNF”. It is unclear what the first and second NNF are referring to because only the first balloon is filled with an NNF material. For purposes of examination, claim 13 will be assumed to read “wherein the NNF material is either a dilatant or rheopectic NNF”.
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.
Claim(s) 1 – 6, 8, 11 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hudgins et al. (US 2007/0093906 A1) in view of Kleiner et al. (US 2019/0224024 A1).
Regarding claim 1, Hudgins discloses a spinal disc replacement device (Abstract), comprising:
a first balloon (paragraph [0050], ref. 62, Fig. 10) configured for insertion through an annulus fibrosis (AF) and into a cavity within an intervertebral disc (IVD),the cavity-surrounded by an annulus fibrosis (AF) (the first balloon is configured to be placed within a disc space and thus is fully capable of being inserted through an AF and into the disc space/cavity, paragraphs [0036 – 38]);
a first material disposed within the first balloon (paragraph [0041] discloses hydrating the ballon by adding fluid which is considered the first material); and
a second balloon physically separate from the first balloon (paragraph [0052] discloses that the first balloon may completely surround second balloon and Fig. 10 shows them as separated), wherein the first and second balloons are configured for in vivo assembly into a balloon-in-a-balloon assembly (BBA) (paragraph [0052]);
wherein the filled balloon-BBA is configured to support vertebrae disposed above the IVD (paragraph [0053]).
Hudgins is silent wherein the first material includes a first non-Newtonian fluid (NNF) and provides an NNF-filled balloon within the cavity.
Kleiner et al. teaches an analogous device (Abstract) comprising the use of a non-Newtonian fluid (NNF) (paragraph [0243]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the first material of Hudgins to be a NNF, as taught by Kleiner, for the purpose of increased viscosity and further control of stability.
Regarding claim 2, Hudgins in view of Kleiner discloses the spinal disc replacement device of claim 1, wherein the cavity is defined by an amount of a nucleus pulposus (NP) removed from the IVD (Hudgins, paragraph [0036]).
Regarding claim 3, Hudgins in view of Kleiner discloses the spinal disc replacement device of claim 1, wherein a size of the cavity is substantially equal to a volume enclosed by the AF, a first vertebral body beneath the IVD, and a second vertebral body above the AF (Hudgins, paragraph [0038]).
Regarding claim 4, Hudgins in view of Kleiner discloses the spinal disc replacement device of claim 1, wherein the NNF-filled balloon occupies a substantial entirety of a volume of the cavity (Hudgins, paragraph [0038]).
Regarding claim 5, Hudgins in view of Kleiner discloses the spinal disc replacement device of claim 1, wherein the NNF-filled balloon has a discoid shape prior to insertion into the IVD or oblate spheroidal shape (Fig. 9 of Hudgins shows a discoid shape).
Regarding claim 6, Hudgins in view of Kleiner discloses the spinal disc replacement device of claim 1, wherein the cavity has an arbitrary shape defined at least in part by an amount of a nucleus pulposus (NP) removed from the IVD (Hudgins, paragraph [0036-38]), and wherein the NNF-filled balloon substantially conforms to the arbitrary shape of the cavity (paragraph [0038]).
Regarding claim 8, Hudgins in view of Kleiner discloses the spinal disc replacement device of claim 1, wherein the second balloon is disposed within the NNF-filled balloon (Hudgins Fig. 10), and wherein the spinal disc replacement device further comprises:
a second material disposed within the second balloon to provide a second filled balloon within the NNF-filled balloon, wherein the NNF-filled balloon and the second filled balloon provide the BBA (Hudgins discloses that spiral implant ref. 24 filles the second balloon);
wherein the second material is different than the first material (the implant if formed of a plastic, such as polyurethane); and
wherein the second filled balloon provides a solid spacer between adjacent vertebral bones, the solid spacer having a diameter equal to a distance between the adjacent vertebral bones while remaining fully enclosed within the NNF-filled balloon (Hudgins, paragraph [0051] discloses that the second balloon is more solid and configured to receive a load from the vertebrae).
Regarding claim 11, Hudgins in view of Kleiner discloses the spinal disc replacement device of claim 8, except wherein a volume ratio of the NNF-filled balloon to the second filled balloon is in a range of about 5:1 to 8:1. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Hudgins in view of Kleiner such that the range is about 5:1 to 8:1 since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 12, Hudgins in view of Kleiner discloses the spinal disc replacement device of claim 8, wherein the second filled balloon has a spheroidal shape (Hudgins, Fig. 10).
Claim(s) 7 and 13 (as best understood) is/are rejected under 35 U.S.C. 103 as being unpatentable over Hudgins et al. (US 2007/0093906 A1) in view of Kleiner et al. (US 2019/0224024 A1) and further in view of Corrigan (US 2018/0318693 A1).
Regarding claim 7, Hudgins in view of Kleiner discloses the spinal disc replacement device of claim 1, except wherein the first NNF includes a dilatant NNF.
Regarding claim 13 (as best understood), Hudgins in view of Kleiner discloses the spinal disc replacement device of claim 8, except wherein one of the first NNF and the second NNF includes a dilatant NNF, and wherein the other one of the first NNF and the second NNF includes a rheopectic NNF.
Corrigan teaches medical and surgical materials for use on the spine (Abstract) wherein the material may be a dilatant NNF (paragraph [0168]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the NNF of Hudgins in view of Kleiner to be a dilatant NNF, as taught by Corrigan, since such materials are force-reactive with improved impact resistance and energy absorption.
Claim(s) 1 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Aflatoon (US 2009/0248159 A1) in view of Kleiner et al. (US 2019/0224024 A1).
Regarding claim 1, Aflatoon discloses a spinal disc replacement device (Abstract), comprising:
a first balloon (paragraph [0051], ref. 134, Fig. 4) configured for insertion through an annulus fibrosis (AF) and into a cavity within an intervertebral disc (IVD),the cavity-surrounded by an annulus fibrosis (AF) (the first balloon is configured to be placed within a disc space and thus is fully capable of being inserted through an AF and into the disc space/cavity, paragraph [0025]);
a first material disposed within the first balloon (paragraph [0052] discloses filling the first balloon with a first material, e.g. liquid or viscous substances); and
a second balloon physically separate from the first balloon (paragraph [0051] discloses a separate second balloon ref. 136), wherein the first and second balloons are configured for in vivo assembly into a balloon-in-a-balloon assembly (BBA) (the balloon are fully capable of being assembled in vivo, paragraph [0054])
wherein the filled balloon-BBA is configured to support vertebrae disposed above the IVD (paragraphs [00 52 - 55]).
Aflatoon is silent wherein the first material includes a first non-Newtonian fluid (NNF) and provides an NNF-filled balloon within the cavity.
Kleiner et al. teaches an analogous device (Abstract) comprising the use of a non-Newtonian fluid (NNF) (paragraph [0243]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the first material of Aflatoon to be a NNF, as taught by Kleiner, for the purpose of increased viscosity and further control of stability.
Regarding claim 8, Aflatoon in view of Kleiner discloses the spinal disc replacement device of claim 1, wherein the second balloon is disposed within the NNF-filled balloon (Aflatoon Fig. 4), and wherein the spinal disc replacement device further comprises:
a second material disposed within the second balloon to provide a second filled balloon within the NNF-filled balloon, wherein the NNF-filled balloon and the second filled balloon provide the BBA (Aflatoon, paragraph [0052]);
wherein the second material is different than the first material (paragraph [0052]); and
wherein the second filled balloon provides a solid spacer between adjacent vertebral bones, the solid spacer having a diameter equal to a distance between the adjacent vertebral bones while remaining fully enclosed within the NNF-filled balloon (Fig. 4 and paragraph [0052] disclose a curring resin a material for second balloon 136 which hardens and thus becomes solid).
Claim(s) 9 - 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Aflatoon (US 2009/0248159 A1) in view of Kleiner et al. (US 2019/0224024 A1) and in view of Trieu (US 2009/0222096 A1).
Regarding claim 9, Aflatoon in view of Kleiner discloses the spinal disc replacement device of claim 8, except wherein the second material includes a bone cement, and wherein the second filled balloon includes a cement-filled balloon.
Trieu teaches an expandable intervertebral disc device (Abstract) comprising a balloon filled with bone cement (paragraph [0044]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the second material of Aflatoon, to be bone cement, as taught by Trieu, for the purpose of the second balloon becoming hard while also being biocompatible (paragraph [0044]).
Regarding claim 10, Aflatoon in view of Kleiner and in view of Trieu discloses the spinal disc replacement device of claim 9, wherein the bone cement includes polymethylmethacrylate (PMMA) (Trieu, paragraph [0044]).
Claim(s) 14 – 17 and 26 are is/are rejected under 35 U.S.C. 103 as being unpatentable over Afzal (US 2009/0076610 A1) in view of Kleiner et al. (US 2019/0224024 A1).
Regarding claim 14, Afzal discloses a spinal disc replacement device (Abstract), comprising:
an upper endplate (Fig. 2-3, ref. 202) and a lower endplate (ref. 204) configured for attachment to vertebral bodies at a bone-implant interface and along respective outer surfaces of the upper and lower endplates (Fig. 4);
a fluid filled balloon interposing the upper endplate and the lower endplate (paragraph [0032], ref. 206), the filled balloon attached to each of the upper and lower endplates along respective inner surfaces of the upper and lower endplates (Figs. 2 – 3); and
an artificial annulus fibrosis (AF) surrounding the NNF-filled balloon (paragraph [0032, 35], refs. 207, 210).
Afzal is silent that the fluid is a non-Newtonian fluid.
Kleiner et al. teaches an analogous device (Abstract) comprising the use of a non-Newtonian fluid (NNF) (paragraph [0243]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the fluid of Afzal to be a NNF, as taught by Kleiner, for the purpose of increased viscosity and further control of stability.
Regarding claim 15, Afzal in view of Kleiner discloses the spinal disc replacement device of claim 14, wherein the upper and lower endplates are composed of a metal, a metal alloy, a plastic, or a combination thereof (Afzal, paragraph [0034]).
Regarding claim 16, Afzal in view of Kleiner discloses the spinal disc replacement device of claim 14, wherein the upper and lower endplates include teeth, screw attachments, or keels along the respective outer surfaces of the upper and lower endplates (paragraph [0048], ref. 218, Fig. 3).
Regarding claim 17, Afzal in view of Kleiner discloses the spinal disc replacement device of claim 14, wherein the upper and lower endplates are coated along the respective outer surfaces of the upper and lower endplates with a porous layer of a different metal that encourages bone from respective ones of the vertebral bodies to grow onto the upper and lower endplates (paragraph [0050]).
Regarding claim 26, Afzal in view of Kleiner discloses the spinal disc replacement device of claim 14, wherein the NNF-filled balloon is attached, by an adhesive, to each of the upper and lower endplates along the respective inner surfaces of the upper and lower endplates (Afzal, paragraph [0055] discloses adhesive to joint together the endplates, fibers and balloons)
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Afzal (US 2009/0076610 A1) in view of Kleiner et al. (US 2019/0224024 A1) and in view of Trieu (US 2009/0222096 A1).
Regarding claim 18, Afzal in view of Kleiner discloses the spinal disc replacement device of claim 14, except for further comprising a cement-filled balloon disposed within the NNF-filled balloon, wherein the cement filled balloon includes polymethylmethacrylate (PMMA).
Trieu teaches an analogous device (Abstract) comprising a first balloon (Fig. 6, ref. 64) and a second PMMA cement-filled balloon (Fig. 6, ref. 62, paragraph [0037]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Afzal to include the second cement-filled balloon, as taught by Trieu, for the purpose of better securing the device the endplates of the patient (paragraph [0037]).
Allowable Subject Matter
Claims 21 – 23, 25, 27 and 28 are allowed.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 TESSA M MATTHEWS whose telephone number is (571)272-8817. The examiner can normally be reached M - F 8am - 1pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Eduardo Robert can be reached at (571) 272-4719. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TESSA M MATTHEWS/Examiner, Art Unit 3773