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 06/12/2026. Claims 1-18 are pending with claims 4-18 newly added.
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, 6, 10, 13-16 and 18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-7 and 9-17 of U.S. Patent No. 12,268,613 in view of Baynham et al. (U.S. 8,083,799 B2).
Concerning claim 1, claim 1 of the patent recites a spinal implant comprising an upper surface including a first porous portion and a first non-porous portion; a lower surface including a second porous portion and a second non-porous portion; a cavity formed through the upper and lower surfaces; first and second side walls extending between the upper and lower surfaces; a front section extending between the upper and lower surfaces; and a rear section extending between the upper and lower surfaces.
Claim 5 of the patent recites that the rear section includes an opening extending into the spinal implant, and claim 6 that the opening is a threaded opening. Claim 7 recites that the threaded opening and the first and second chamfer are configured to cooperate with an insertion tool for insertion of the spinal implant at a surgical site.
Claim 9 of the patent independently recites a body having a front end, a rear end, and opposed side walls extending between the ends; upper and lower surfaces defined respectively by a non-porous upper outer rim and a non-porous lower outer rim; a non-porous front wall extending at the front end between at least the upper and lower outer rims; and a non-porous rear wall extending at the rear end between at least the upper and lower outer rims.
Claim 14 of the patent recites that each of the side walls includes openings extending into the cavity.
The patent claims therefore recite the elongate body architecture of claim 1 of the application including a front section and a rear section, the rear section having a rear wall, upper and lower surfaces extending therebetween, first and second side walls extending between the upper and lower surfaces, openings in each side wall, an internally threaded opening at the rear section, chamfers, and cooperation with an insertion tool.
Concerning claim 2, claim 9 of the patent recites each of the side walls including at least one non-porous strut extending therebetween, and a porous structure integrally formed with the upper rim, the lower rim, and the at least one strut, the porous structure extending from the body outer perimeter to the body inner perimeter such that the porous structure is encased within a non-porous structure. Claim 12 of ’613 further recites that the at least one non-porous strut contacts the opposed side walls, and claim 13 that the strut contacts the cavity.
Application claim 2 recites a body including porous and non-porous sections, with one or more non-porous struts extending through the porous section from the first side wall to the second side wall, and is therefore anticipated by, or at minimum rendered obvious by, claims 9, 12, and 13 of the patent. A non-porous strut that contacts both opposed side walls and passes through a porous structure encased in non-porous material is not patentably distinct from a non-porous strut extending through the porous section from the first side wall to the second side wall.
However, the application claims differ from the patent claims in that the application claims recite: (a) first and second recesses in the first and second side walls; (b) chamfered edges at the intersection of the first side wall with the upper surface and of the second side wall with the lower surface; (c) the insertion tool positively recited as an element of a claimed system; and (d) insertion in a first orientation with the side walls contacting the vertebrae, followed by rotation 90° to a second orientation with the upper and lower surfaces contacting the vertebrae.
As to (a), claim 14 of the patent recites openings extending into the cavity in each side wall. To the extent the instant “first recess” and “second recess” are broader than or equivalent to such openings, no patentable distinction results.
As to (c), claim 7 of the patent already recites the implant as configured to cooperate with an insertion tool. Positively reciting the cooperating tool as a system element rather than reciting the implant as configured to cooperate with it is not a patentable distinction. The recitations that the tool is “removably attachable” and “adapted to insert… and rotating” remain functional.
As to (d), and as further support for (a), Baynham teaches a spinal implant having a first recess formed in one elongated side wall and a second recess formed in the opposite elongated side wall, provided specifically to reduce the frictional forces opposing rotation and to reduce the space traversed between adjacent vertebrae, thereby minimizing stress on the vertebrae; an implant tool removably connected to a threaded opening in an end wall; and insertion of the implant in a low-profile orientation with the side walls contacting the adjacent vertebrae, followed by rotation of approximately 90° so that the toothed upper and lower peripheries engage the vertebral end plates.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the implant of the patent claims with the side wall recesses and the insert-and-rotate methodology of Baynham, for the reasons Baynham expressly identifies.
Regarding claim 3, claim 10 of the patent recites that the upper and lower surfaces comprise surface serrations, and that a contour of each surface serration is defined by a non-porous cross strut and a curved contoured portion. A serration is by definition a projection extending beyond the surface from which it rises; a non-porous cross strut defining the contour of such a serration therefore extends beyond the upper or lower surface.
Regarding claim 4, claim 14 of the patent recites that each of the side walls includes openings extending into the cavity. Claim 15 recites that each of the openings includes porous and non-porous sections. An opening extending through a side wall into the cavity is a lateral window.
Regarding claim 6, claim 3 of the patent recites that the front section is tapered to define a wedge-shaped end, and claim 4 that the wedge-shaped end is configured to distract vertebral bodies during insertion. Baynham further teaches a leading end configured for low-profile entry between the adjacent vertebrae prior to rotation. The recitation “to permit insertion… in the first orientation” is functional.
Regarding Claim 10, claim 10 of the patent recites that the upper surface and lower surface comprise surface serrations.
Regarding claim 13, claim 16 of the patent recites a porous structure having an average pore diameter between 100 and 1000 microns, and claim 17 recites an average porosity between 30% and 80%. The ranges are coextensive.
Regarding claim 14, the claimed range falls entirely within the 30%–80% range of claim 17 of the patent. Where the claimed range lies inside a range disclosed by the reference, a prima facie case of obviousness exists.
Concerning claim 15, claim 1 of the patent recites a cavity formed through the upper and lower surfaces. Claim 9 recites a porous structure extending from the body outer perimeter to the body inner perimeter about the cavity, and claim 11 recites that the inner perimeter is defined by porous and non-porous sections.
Concerning claim 16, the cavity of claim 1 of the patent, being an open volume formed through the upper and lower surfaces, is structurally capable of containing such material. This is a statement of intended use.
Concerning claim 18, claim 9 of the patent recites a porous structure extending from the body outer perimeter to the body inner perimeter such that the porous structure is encased within a non-porous structure, with the upper and lower surfaces defined by non-porous outer rims forming non-porous exterior surfaces, and each side wall including at least one non-porous strut. Claim 12 recites that the non-porous strut contacts the opposed side walls.
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, 4, 6-8, 10 and 12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Baynham et al. (U.S. 8,083,799 B2).
Regarding claim 1, Baynham discloses a spinal implant system comprising a spinal implant (cage 10) having an elongate body with: a central longitudinal axis extending through the body (Baynham, claim 1, referencing the longitudinal centerline CL of the implant; Fig. 5); a front section and a rear section (end walls 15 and 14), the rear section having a rear wall and an internally threaded opening (col. 3; end wall 15 has threaded opening 32 to which the implant tool is removably connected, and Baynham expressly states that openings 31 and 32 may be reversed, such that the internally threaded opening is located in the trailing end wall 14); an upper surface and a lower surface each extending between the front section and the rear section (top portion 11 and bottom portion 13, defined by the toothed peripheries of the elongated side walls bounding opening 30); a first side wall and a second side wall (elongated side walls 16 and 12) extending between the upper surface and the lower surface on first and second sides of the longitudinal axis, the first and second side walls comprising a first recess and a second recess, respectively (recess 80 formed on side wall 16; recess 81 formed on the opposite side wall 12 — see Figs. 6 and 8, and Baynham claim 1, reciting that the first recess is formed on one elongated side and the second recess is located on the elongated side opposite the first recess);
wherein an intersection of the first side wall and the upper surface comprises a first chamfered edge and an intersection of the second side wall and the lower surface comprises a second chamfered edge (first recess 80 is located at the top portion 11 and is cut into the exterior surface of side wall 16, and second recess 81 is an inverse mirror image located at the bottom portion 13 of side wall 12; the edge of each recess slopes at approximately 45° from the longitudinal centerline, and may range from 1° to 89°, thereby defining a chamfered edge at each said intersection); and wherein the rear wall is generally perpendicular to the first side wall and the second side wall (end walls 14 and 15 are rectilinear, with the side walls attached to opposite sides of the rectangle). Baynham further discloses an insertion tool removably attachable to the implant and adapted to insert the implant between adjacent vertebrae in a first orientation with the first and second side walls configured to contact the adjacent vertebrae, and to rotate the implant 90° to a second orientation with the upper and lower surfaces configured to contact the adjacent vertebrae. Specifically, Baynham teaches an implant tool removably connected to the threaded opening and used to manipulate the implant, that the implant is slid into the prepared site with one side wall contacting the upper vertebra and the other side wall contacting the lower vertebra in a low-profile insertion orientation, and that the implant is thereafter rotated approximately 90° to engage the teeth of the top and bottom peripheries with the vertebral end plates.
Concerning claim 4, the first recess includes a first lateral window (see Fig. 1, element 18) extending through the first side wall and the second recess includes a second lateral window (see Fig. 1, element 18 (opposite)) extending through the second side wall.
Concerning claim 6, wherein the front section includes a nose (see Fig. 1, near element 15) having sidewalls angled to permit insertion of the implant between the adjacent vertebrae in the first orientation.
Concerning claim 7, wherein the implant further includes a visual identifier (see Fig. 4, element 65) at the rear section configured to identify an orientation of the implant.
Concerning claim 8, wherein the visual identifier includes a dimple (see Fig. 4, element 61) provided at the rear section.
Concerning claim 10, wherein each of the upper surface and the lower surface includes a plurality of serrations (see Fig. 1, element 25).
Concerning claim 12, wherein the serrations (see Fig. 1, element 25) are oriented at an angle within a range of 60 degrees to 80 degrees to resist back-out of the implant from between the adjacent vertebrae.
Concerning claim 15, wherein the body further includes a cavity formed through the upper surface and the lower surface, an interior of the cavity being at least partially formed of porous material (see col. 1, lines 19-26).
Concerning claim 16, wherein the cavity is configured to contain a bone growth promoting material therein (see col. 1, lines 19-26).
Concerning claim 17, wherein the body includes titanium and is formed by an additive manufacturing process (see col. 2, lines 61-65).
Concerning claim 18, wherein the first side wall and the second side wall are each formed solid on an exterior of the body (see col. 2, lines 61-65) and porous on an interior of the body (see col. 1, line 66 – col. 2, line 2).
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) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Baynham et al. (U.S. 8,083,799 B2) in view of Paul (U.S. 2005/0143822 A1).
Baynham et al. disclose the invention substantially as described above. However, Baynham et al. do not explicitly disclose than an intersection of the first side wall and the lower surface includes a third chamfered edge and an intersection of the second side wall and the upper surface comprises a fourth chamfered edge.
Paul disclose a spinal implant having a chamfered edge (see Fig. 2A, element 40) in the same field of endeavor for the purpose of providing more efficient insertion of the implant.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Bayham’s implant to include chamfered edges, as disclosed by Paul in order to prevent a squared leading corner of the implant from scraping or gouging the vertebral endplate.
Allowable Subject Matter
Claim 11 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Response to Arguments
Applicant’s arguments filed 06/12/2026 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.
Conclusion
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 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
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