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 .
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.
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Claim(s) 1 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 10 of U.S. Patent No. 12,343,264. Although the claims at issue are not identical, they are not patentably distinct from each other because:
The table below shows the application claims and the patent claims side by side for direct comparison, with the differences between the claims are highlighted below by bolding all the limitations that differ, italicizing additional limitations, and underlining limitations that will be addressed below.
Application Claims:
Patent Claims:
1. An intervertebral implant comprising:
a body insertable into an intervertebral space, the body comprising a first face, a second face connected to and opposite the first face, and an axis of rotation extending from the first face to the second face, wherein the body defines a spherical segment- shaped hollow space between the first and second faces configured to accommodate an engagement portion of an insertion device, the hollow space being accessible from outside the body through an opening formed between the first and second faces; wherein when viewed in a cross-section perpendicular to the axis of rotation, the intervertebral implant has an outer profile defining the opening that has a first abutment surface with a flat contour for engaging the insertion device in a form-fit manner at a first angular position and a second abutment surface with a flat contour for engaging the insertion device in a form-fit manner at a different second angular position when the engagement portion of the insertion device is in the hollow space.
9. An intervertebral implant comprising: a body insertable into an intervertebral space, the body comprising a first face, a second face connected to and opposite the first face, and an axis of rotation extending from the first face to the second face, wherein the body defines a hollow space between the first and second faces configured to accommodate an engagement portion of an insertion device, the hollow space being accessible from outside the body through an opening formed between the first and second faces; wherein when viewed in a cross-section perpendicular to the axis of rotation, the intervertebral implant has an outer profile defining the opening that has a first abutment surface having a flat contour that engages the insertion device in a form-fit manner at a first angular position, a second abutment surface having a flat contour that engages the insertion device in a form-fit manner at a second angular position, and a curved contour that extends circumferentially around the axis of rotation between the first and second abutment surfaces to facilitate pivoting of the intervertebral implant relative to the insertion device at least partially between the first and second angular positions, the curved contour further being configured to engage the insertion device to hold the intervertebral implant at at least one angular position different from the first and second angular positions when the engagement portion of the insertion device is in the hollow space.
10. The intervertebral implant of claim 9, wherein the hollow space comprises a spherical portion.
As is evident from the table above Patent claim 1 discloses all of the features of application claim 1, while Patent claim 10 uses slightly different wording e.g. “a spherical portion” instead of “spherical segment- shaped”; it is clear that a spherical portion would consist of a spherical shaped segment.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 8-9, 11, 13, 15-16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Andre et al. (U.S. Pub. No. 2005/0096745 A1, hereinafter “Andre”).
Andre discloses, regarding claim 8, an intervertebral implant (1, see Fig. 1) comprising: a body (e.g. body of 1) insertable into an intervertebral space (see para. [0031]), the body comprising a first face (see annotated Fig. 1 below), a second face (see annotated Fig. 1 below) connected to and opposite the first face (see Fig. 1), and an axis of rotation extending from the first face to the second face (see annotated Fig. 1 below), wherein the body defines a first hollow space (9) that is accessible through a first opening (14) formed between the first and second faces (see Fig. 1, see ABSTRACT) and a second hollow space (8) that is accessible through a second opening (14) formed between the first and second faces (see Fig. 1, see ABSTRACT), wherein the first and second hollow spaces are shaped similarly to interchangeably accommodate an engagement portion of an insertion device (see Fig. 1, see ABSTRACT, see para. [0030]); wherein the first opening extends circumferentially around the axis of rotation from a first end to a second end that is angled relative to the first end to facilitate circumferential pivoting of the intervertebral implant relative to the insertion device around the axis of rotation when the engagement portion of the insertion device is in the first hollow space (see annotated Fig. 1 below), and wherein the second opening extends circumferentially from a first end to a second end that is substantially parallel to the first end (see annotated Fig. 1 below) to restrict circumferential pivoting of the intervertebral implant relative to the insertion device when the engagement portion of the insertion device is in the second hollow space (e.g. when cage carrying device 15 is locked to cage 1, see para. [0040]).
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Regarding claim 9, wherein a width of the first opening measured circumferentially around the axis of rotation is greater than a height of the first opening measured in a direction parallel to the axis of rotation (see Fig. 1), and wherein a height of the second opening measured in the direction parallel to the axis of rotation is at least a width of the second opening measured circumferentially around the axis of rotation (see Fig. 1, note that a height of the second opening is at least a width of the second opening).
Regarding claim 11, wherein when viewed in a cross-section perpendicular to the axis of rotation, at least part of an outer profile defining the first opening has a curved contour that extends circumferentially around the axis of rotation to facilitate the pivoting of the intervertebral implant relative to the insertion device (see annotated Fig. 1 above).
Regarding claim 13, wherein a sidewall that extends between the first and second faces comprises two opposite long sides and two opposite short sides extending between the long sides, and wherein the first opening extends from a first one of the long sides to a first one of the short sides (see annotated Fig. 1 above).
Regarding claim 15, wherein the second opening is configured to connect the intervertebral implant to the insertion device at a fixed angular position (e.g. when cage carrying device 15 is locked to cage 1, see para. [0040]).
Regarding claim 16, wherein the intervertebral implant is monolithic (see Fig. 1).
Claim Rejections - 35 USC § 103
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) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Andre, as applied to claim 8 above, and in view of Asaad (U.S. Pub. No. 2011/0264218 A1, hereinafter “Asaad”).
Andre discloses all of the features of the claimed invention, as previously set forth above, except regarding claim 12, wherein when viewed in a cross-section perpendicular to the axis of rotation, at least part of an outer profile defining the first opening has a flat contour for engaging the insertion device in a form-fit manner at a first angular position.
Asaad discloses an intervertebral implant (10, see Fig. 1A), with an axis of rotation (see annotated Fig. 1D below), wherein when viewed in a cross-section perpendicular to the axis of rotation (see annotated Fig. 1D below), the intervertebral implant has an outer profile defining the opening (56, see Fig. 1D) that has a flat contour (see annotated Fig. 1D below) for engaging the insertion device in a form-fit manner (see paras. [0072]-[0073] and [0079]) in order to provide distinct stops for the amount of angulation that enable the prevention of rotation when the insertion instrument is positioned against the surfaces until the insertion instrument is loosened to enable repositioning at a different amount of angulation (see paras. [0072], [0079] and [0081]).
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It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the intervertebral implant in Andre to include flat contours in view of Asaad in order to provide distinct stops for the amount of angulation that enable the prevention of rotation when the insertion instrument is positioned against the surfaces until the insertion instrument is loosened to enable repositioning at a different amount of angulation.
Claim(s) 1-7, 17-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Biedermann et al. (U.S. Pub. No. 2017/0056194 A1, hereinafter “Biedermann”) in view of Asaad (U.S. Pub. No. 2011/0264218 A1, hereinafter “Asaad”).
Biedermann discloses, regarding claim 1, an intervertebral implant (1, see Figs. 2A-2B) comprising: a body (e.g. body of 1) insertable into an intervertebral space (see para. [0077]), the body comprising a first face (17), a second face (16) connected to and opposite the first face (see Fig. 2A), and an axis of rotation extending from the first face to the second face (“A”, see Fig. 6A), wherein the body defines a spherical segment- shaped hollow space (5b, see para. [0087]) between the first and second faces configured to accommodate an engagement portion (56) of an insertion device (50, see Fig. 2B), the hollow space being accessible from outside the body through an opening (8) formed between the first and second faces (see Fig. 2A, see para. [0087]).
Regarding claim 2, wherein the axis of rotation extends through a center of the hollow space (see Figs. 6A-6B), such that the insertion device is pivotable relative to the insertion device around the axis of rotation (see Fig. 6B) at least between a first and a second angular positions when the engagement portion of the insertion device is in the hollow space (see annotated Fig. 6B below).
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Regarding claim 6, wherein a sidewall that extends between the first and second faces comprises two opposite long sides and two opposite short sides extending between the long sides, and wherein the opening extends from one of the long sides to one of the short sides (see annotated Fig. 6B above).
Regarding claim 7, wherein the intervertebral implant is monolithic (see Fig. 2B).
Biedermann discloses, regarding 17, an intervertebral implant (1, see Figs. 2A-2B) comprising: a body (e.g. body of 1) insertable into an intervertebral space (see para. [0077]), the body comprising a first face (17), a second face (16) connected to and opposite the first face (see Fig. 2A), and an axis of rotation extending from the first face to the second face (“A”, see Fig. 6A), wherein the body defines a hollow space (5) between the first and second faces configured to accommodate an engagement portion (56) of an insertion device (50, see Fig. 2B), the hollow space being accessible from outside the body through an opening (8) formed between the first and second faces (see Fig. 2A, see para. [0087]).
Biedermann fails to disclose, regarding claim 1, wherein when viewed in a cross-section perpendicular to the axis of rotation, the intervertebral implant has an outer profile defining the opening that has a first abutment surface with a flat contour for engaging the insertion device in a form-fit manner at a first angular position and a second abutment surface with a flat contour for engaging the insertion device in a form-fit manner at a different second angular position when the engagement portion of the insertion device is in the hollow space; regarding claim 3, wherein the axis of rotation is substantially parallel to a sidewall that extends between the first and second faces; regarding claim 4, wherein when viewed in the cross-section perpendicular to the axis of rotation, the outer profile defining the opening of the intervertebral implant further has a curved contour that extends circumferentially around the axis of rotation between the first and second abutment surfaces; regarding claim 5, wherein the first and second angular positions are arranged at about 90° relative to each other; regarding claim 17, wherein when viewed in a cross-section perpendicular to the axis of rotation, the intervertebral implant has an outer profile defining the opening that has three distinct abutment surfaces each having a flat contour for respectively engaging the insertion device in a form-fit manner at three different angular positions and a separate curved contour that extends circumferentially around the axis of rotation to facilitate pivoting of the intervertebral implant relative to the insertion device when the engagement portion of the insertion device is in the hollow space; regarding claim 18, wherein two of the three distinct abutment surfaces are arranged at about 90° relative to each other; regarding claim 19, wherein a third distinct abutment surface of the three distinct abutment surfaces is arranged between and separates the two of the three distinct abutment surfaces; and regarding claim 20, wherein a first one of the three distinct abutment surfaces extends past a first end of the opening in a first circumferential direction around the axis of rotation, while a second one of the three distinct abutment surfaces extends past an opposite second end of the opening in a circumferential direction around the axis of rotation opposite the first circumferential direction.
Asaad discloses an intervertebral implant (10, see Fig. 1A), with an axis of rotation (see annotated Fig. 1D below), wherein when viewed in a cross-section perpendicular to the axis of rotation (see annotated Fig. 1D below), the intervertebral implant has an outer profile defining the opening (56, see Fig. 1D) that has a first abutment surface with a flat contour (see annotated Fig. 1D below) for engaging the insertion device in a form-fit manner (see paras. [0072]-[0073] and [0079]) at a first angular position (see annotated Fig. 1D below) and a second abutment surface with a flat contour (see annotated Fig. 1D below) for engaging the insertion device in a form-fit manner at a different second angular position when the engagement portion of the insertion device is in the hollow space (see paras. [0072]-[0073] and [0079]); wherein the axis of rotation is substantially parallel to a sidewall that extends between the first and second faces (see annotated Fig. 1D below); wherein when viewed in the cross-section perpendicular to the axis of rotation, the outer profile defining the opening of the intervertebral implant further has a curved contour that extends circumferentially around the axis of rotation between the first and second abutment surfaces (see annotated Fig. 1A below); wherein the first and second angular positions are arranged at about 90° relative to each other (see Fig. 5); wherein when viewed in a cross-section perpendicular to the axis of rotation (see Fig. 1D), the intervertebral implant has an outer profile defining the opening that has three distinct abutment surfaces each having a flat contour (see annotated Fig. 1D below) for respectively engaging the insertion device in a form-fit manner at three different angular positions (see paras. [0072]-[0073] and [0079]) and a separate curved contour that extends circumferentially around the axis of rotation to facilitate pivoting of the intervertebral implant relative to the insertion device when the engagement portion of the insertion device is in the hollow space (see annotated Fig. 1A below); wherein two of the three distinct abutment surfaces are arranged at about 90° relative to each other (see Fig. 5); wherein a third distinct abutment surface of the three distinct abutment surfaces is arranged between and separates the two of the three distinct abutment surfaces (see Fig. 1D); and wherein a first one of the three distinct abutment surfaces extends past a first end of the opening in a first circumferential direction around the axis of rotation (see Fig. 1D), while a second one of the three distinct abutment surfaces extends past an opposite second end of the opening in a circumferential direction around the axis of rotation opposite the first circumferential direction (see Fig. 1D) in order to provide distinct stops for the amount of angulation that enable the prevention of rotation when the insertion instrument is positioned against the surfaces until the insertion instrument is loosened to enable repositioning at a different amount of angulation (see paras. [0072], [0079] and [0081]).
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It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the intervertebral implant in Biedermann to include first, second, and third abutment surfaces with flat contours at first, second and third angular positions in view of Asaad in order to provide distinct stops for the amount of angulation that enable the prevention of rotation when the insertion instrument is positioned against the surfaces until the insertion instrument is loosened to enable repositioning at a different amount of angulation.
Allowable Subject Matter
Claim(s) 10, 14 is/are 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.
The following is a statement of reasons for the indication of allowable subject matter: The claims in the instant application have not been rejected using prior art because no references, or reasonable combination thereof could be found which disclose, or suggest:
An intervertebral implant comprising: a body with a first face, a second face connected to and opposite the first face, wherein the body defines a first opening extends circumferentially around the axis of rotation from a first end to a second end that is angled relative to the first end to facilitate circumferential pivoting of the implant relative to the insertion device around the axis of rotation when the engagement portion of the insertion device is in the first hollow space, and a second opening extends circumferentially from a first end to a second end that is substantially parallel to the first end to restrict circumferential pivoting of the intervertebral implant relative to the insertion device when the engagement portion of the insertion device is in the second hollow space, wherein a width of the first opening measured circumferentially around the axis of rotation is greater than a height of the first opening measured in a direction parallel to the axis of rotation, and wherein a height of the second opening measured in the direction parallel to the axis of rotation is at least a width of the second opening measured circumferentially around the axis of rotation; and as per claim 10, wherein the height of the second opening is greater than the width of the second opening.
An intervertebral implant comprising: a body with a first face, a second face connected to and opposite the first face, wherein the body defines a first opening extends circumferentially around the axis of rotation from a first end to a second end that is angled relative to the first end to facilitate circumferential pivoting of the intervertebral implant relative to the insertion device around the axis of rotation when the engagement portion of the insertion device is in the first hollow space, and a second opening extends circumferentially from a first end to a second end that is substantially parallel to the first end to restrict circumferential pivoting of the intervertebral implant relative to the insertion device when the engagement portion of the insertion device is in the second hollow space; wherein a sidewall that extends between the first and second faces comprises two opposite long sides and two opposite short sides extending between the long sides, and wherein the first opening extends from a first one of the long sides to a first one of the short sides; and as per claim 14, wherein the second opening is formed entirely in one of the long sides or one of the short sides.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892.
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/M.C.G/ Examiner, Art Unit 3773 /JACQUELINE T JOHANAS/Primary Patent Examiner, Art Unit 3773
