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 filed 09/22/2025 have been fully considered but they are not persuasive.
Regarding the interpretation of the “coupling mechanism” in claims 6, 13 and 18, applicant argues that the coupling mechanism is defined by a sufficient act for perform the claimed function. The only recitation of an act was found in the limitation “configured to facilitate coupling”. This is not found persuasive because such a limitation does not specify the any detailed requirements or steps of the “acts”. The recited “act” appears to be a recitation of the function, “coupling”. Therefore, the acts themselves are only generically claimed and do provide sufficient steps to perform the function of coupling.
Regarding the rejection under Dewey, applicant argues that Dewey does not describe or depict a vertical implant wherein the body includes a plurality of fenestrated openings configured to facilitate migration of injected bone cement out of the interbody cage. The Office respectfully disagrees. Dewey discloses a plurality of fenestrated openings (refs. 60, 160). Dewey discloses that the openings are configured to facilitate the flow of bone graft and/or other material from the body. The limitation of the material being injected is treated as an intended use limitation in which the bone material is fully capable of being injected via an injection tool.
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 – 7 and 11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dewey et al. (US 2012/0101576 A1).
Regarding claim 1, Dewey discloses a system for decompression and vertebral fusion (Abstract), the system comprising:
a vertebral implant (Fig. 2):
an interbody cage comprising:
a superior endplate (see remarked Fig. 2 below);
an inferior endplate (see remarked Fig. 2 below);
a body between the superior endplate and the inferior endplate (Fig. 2, refs. 90, 74, 34); and
an injection port (paragraph [0035], ref. 44) configured for receiving a bone cement injector such that bone cement may be injected through the injection port into the body (paragraph [0035]);
wherein the body includes a plurality of fenestrated openings (refs. 60, 106) configured to facilitate migration of injected bone cement out of the interbody cage, into disc space, and around the vertebral implant (paragraph [0038]); and
bone cement for injection into the interbody cage and migration out of the interbody cage, into disc space, and around the vertebral implant (paragraphs [0035-38]).
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Regarding claim 2, Dewey discloses the system of claim 1, wherein the body is defined by a wall extending at least partially between the superior endplate and the inferior endplate (the exterior surface of refs. 90, 74 and 34 is considered to be the wall).
Regarding claim 3, Dewey discloses system of claim 2, wherein the wall includes the plurality of fenestrated openings for facilitating the migration of injected bone cement (refs. 60, 106).
Regarding claim 4, Dewey discloses the system of claim 1, wherein the wall is telescoping and a height of the interbody cage may be adjusted by telescoping the wall (paragraph [0004]).
Regarding claim 5, Dewey discloses the system of claim 4, wherein at least one of the superior endplate and the inferior endplate includes fenestrated openings for facilitating the migration of injected bone cement (Fig. 3, ref. 60).
Regarding claim 6, Dewey discloses the system of claim 1, wherein the injection port includes a coupling mechanism configured to facilitate coupling to the bone cement injector (paragraph [0035] discloses a threaded connection which is considered to the coupling mechanism).
Regarding claim 7, Dewey discloses the system of claim 6, wherein the coupling mechanism is threading within an inner cannula of the injection port (paragraph [0035\).
Regarding claim 11, Dewey discloses the system of claim 1, wherein the superior endplate has a width and the inferior endplate has a width, and wherein the width of the inferior endplate matches the width of the superior endplate (Fig. 1).
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) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dewey et al. (US 2012/0101576 A1) in view of Smith et al. (US 9,700,425 B1).
Regarding claim 9, Dewey discloses the system of claim 1, except wherein both of the superior endplate and the inferior endplate includes fenestrated openings for facilitating the migration of injected bone cement ().
Smith teaches an analogous system (Abstract) wherein endplates include fenestrated openings (ref. 25, Fig. 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 both endplates of Dewey to include fenestrated openings, as taught by Smith, to better promote bone fusion (Smith, Col. 5, ref. 55 – 65).
Claim(s) 8, 13, 18 - 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dewey et al. (US 2012/0101576 A1) in view of Capote (US 2012/0109303 A1).
Regarding claim 8, Dewey discloses the system of claim 6, except wherein the injection port further includes a seal for sealing the injection port such that injected bone cement cannot exit the injection port away from the interbody cage.
Capote teaches an analogous system (Abstract) wherein an injection port (Fig. 8, ref. 66) further includes a seal for sealing the injection port such that injected bone cement cannot exit the injection port away from the interbody cage (paragraph [0044] discloses a self-sealing valve). 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 system of Dewey such that wherein the injection port further includes a seal for sealing the injection port such that injected bone cement cannot exit the injection port away from the interbody cage, as taught by Capote for the purpose of preventing injectable substances or material from flowing in one direction or another (paragraph [0044]).
Regarding claim 13, Dewey discloses a vertebral implant for decompression and vertebral fusion (Abstract), the implant comprising:
an interbody cage (Fig. 2) comprising:
a superior endplate (see remarked Fig. 2 below);
an inferior endplate (see remarked Fig. 2 below);
a body between the superior endplate and the inferior endplate (refs. 90, 74, 34), wherein
the body is defined by a wall extending between and coupled to the superior endplate and the inferior endplate (the outer surface is considered to be the wall), and wherein the wall includes a plurality of fenestrated openings (refs. 60, 106); and
an injection port (ref. 44) configured for receiving a bone cement injector such that bone cement may be injected through the injection port into the body (paragraph [0035]), wherein the injection port includes a coupling mechanism configured to facilitate coupling to the bone cement injector (paragraphs [0038, 55] discloses threads) and;
wherein the fenestrated openings are configured to facilitate migration of injected bone cement out of the interbody cage, into disc space, and around the vertebral implant (paragraph [0038]).
Dewey is silent regarding a seal for sealing the injection port such that injected bone cement cannot exit the injection port away from the interbody cage.
Capote teaches an analogous system (Abstract) wherein an injection port (Fig. 8, ref. 66) further includes a seal for sealing the injection port such that injected bone cement cannot exit the injection port away from the interbody cage (paragraph [0044] discloses a self-sealing valve). 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 system of Dewey such that wherein the injection port further includes a seal for sealing the injection port such that injected bone cement cannot exit the injection port away from the interbody cage, as taught by Capote for the purpose of preventing injectable substances or material from flowing in one direction or another (paragraph [0044]).
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Regarding claim 18, Dewey discloses a vertebral implant for decompression and vertebral fusion (Abstract), the implant comprising:
an expandable interbody cage (Figs. 1 – 2) comprising:
a superior endplate (see remarked Fig. 2 below);
an inferior endplate (see remarked Fig. 2 below);
a body between the superior endplate and the inferior endplate (Fig. 2, refs. 90, 74, 34), wherein the body is defined by a wall extending at least partially between the superior endplate and the inferior endplate (the outer surfaces are considered to be the wall), wherein the wall includes a plurality of fenestrated openings (ref. 60);
an injection port (ref. 44) configured for receiving a bone cement injector such that bone cement may be injected through the injection port into the body (paragraph [0035]), wherein the injection port includes a coupling mechanism configured to faciliate coupling to the bone cement injector (paragraph [0035] discloses threads);
wherein the fenestrated openings are configured to facilitate migration of injected bone cement out of the interbody cage, into disc space, and around the vertebral implant (paragraph [0038]).
Dewey is silent regarding a seal for sealing the injection port such that injected bone cement cannot exit the injection port away from the interbody cage.
Capote teaches an analogous system (Abstract) wherein an injection port (Fig. 8, ref. 66) further includes a seal for sealing the injection port such that injected bone cement cannot exit the injection port away from the interbody cage (paragraph [0044] discloses a self-sealing valve). 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 system of Dewey such that wherein the injection port further includes a seal for sealing the injection port such that injected bone cement cannot exit the injection port away from the interbody cage, as taught by Capote for the purpose of preventing injectable substances or material from flowing in one direction or another (paragraph [0044]).
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Regarding claim 19, Dewey in view of Capote discloses the vertebral implant of claim 18, wherein the interbody cage is expandable in an inferior/superior direction (Figs. 1 – 2, Dewey).
Regarding claim 20, Dewey in view of Capote discloses the vertebral implant of claim 19, wherein the body is telescoping (Dewey, paragraph [0004]).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dewey et al. (US 2012/0101576 A1) in view of Josse et al. (US 2017/0333219 A1)
Regarding claim 10, Dewey discloses the system of claim 1, except wherein the superior endplate has a width and the inferior endplate has a width, and wherein the width of the inferior endplate exceeds the width of the superior endplate.
Josse teaches an analogous device (Abstract) wherein a superior endplate (ref. 22) has a width and the inferior endplate (ref. 26) has a width, and wherein the width of the inferior endplate exceeds the width of the superior endplate (Fig. 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 system of Dewey such that the width of the inferior endplate exceeds the width of the superior endplate, as taught by Josse, for the purpose of better the anatomical width of the vertebra and for improved stability by having a broader base of support.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dewey et al. (US 2012/0101576 A1) in view of Paz et al. (“Graphene oxide versus graphene for optimization of PMMA bone cement for orthopedic applications”, 2017) (see attached copy)
Regarding claim 12, Dewey discloses the system of claim 1, wherein the bone cement comprises a polymethyl methacrylate (paragraph [0035], “PMMA”), but is silent that the PMMA is modified to have a low polymerization temperature and high porosity compare to unmodified polymethyl methacrylate.
Paz teaches that adding graphene oxide (GO) to PMMA results in lower curing heat or peak temperature compared to stand PMMA (Abstract, section 3.4 Thermal properties) and that porosity increased (section 3.3 Porosity). 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 bone cement of Dewey such that the PMMA is modified to have a low polymerization temperature and high porosity compare to unmodified polymethyl methacrylate, as taught by Paz, for the purpose of improved mechanical performance of the bone cement (section 5, conclusions).
Claim(s) 14 - 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dewey et al. (US 2012/0101576 A1) in view of Capote (US 2012/0109303 A1) and in view of Zdeblick et al. (US 6,613,091 B1).
Regarding claim 14, Dewey in view of Capote discloses the vertebral implant of claim 13, except wherein the seal comprises an end cap.
Zdeblick teaches a vertebral implant (Abstract) comprising an end cap (ref. 300). 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 implant of Dewey in view of Capote such that the seal comprises an end cap, as taught by Zdeblick, for the purpose of preventing expulsion of material (Col. 15, lines 8 – 12).
Regarding claim 17, Dewey in view of Capote and in view of Zdeblick discloses the vertebral implant of claim 14, wherein at least one of the superior endplate and the inferior endplate includes a plurality of fenestrated openings to facilitate the migration of injected bone out of the interbody cage, into disc space, and around the vertebral implant (Fig. 3, ref. 54, 60, 86 and 104).
Claim(s) 15 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dewey et al. (US 2012/0101576 A1) in view of Capote (US 2012/0109303 A1) and in view of Zdeblick et al. (US 6,613,091) and in view of Wallenstein et al. (US 2017/0079807 A1).
Regarding claim 15, Dewey in view of Capote and in view of Zdeblick discloses the vertebral implant of claim 14, except wherein the fenestrated openings are either evenly distributed over the body or distributed more densely in a middle portion of the body than at upper and lower ends of the body.
Wallenstein teaches an analogous device (Abstract) comprising a body (ref. 510) and a plurality of openings distributed more densely in a middle portion of the body that at upper and lower ends (Fig. 1 shows more opening around the middle of the body than at the ends). 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 openings of Dewey in view of Capote and in view of Zdeblick such that the fenestrated openings are distributed more densely in a middle portion of the body than at upper and lower ends of the body for the purpose of enhanced bone growth around the body.
Regarding claim 16, Dewey in view of Capote and in view of Zdeblick and in view of Wallenstien discloses the vertebral implant of claim 15, wherein the fenestrated openings are distributed more densely in a middle portion of the body than at upper and lower ends of the body (Wallenstien, Fig. 1).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892 for references used in the current rejection not previously cited.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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