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 .
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) 1-2 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schneid et al. (U.S. Pub. No. 2007/0260316 A1, hereinafter “Schneid”).
Schneid discloses, regarding claim 1, an implant (1, see Figs. 1-2) for insertion into an intervertebral disc space between two adjacent vertebrae (2-3, see Fig. 1), the implant comprising: a first component (4) having an outer surface (see annotated Fig. 2 below) for engaging one of the adjacent vertebrae (see Fig. 1) and an inner surface opposite the outer surface (see annotated Fig. 2 below), the first component including a fixation element (10) extending from the outer surface (see Fig. 2); a second component (5) having an outer surface for engaging the other of the adjacent vertebrae (see annotated Fig. 2 below) and an inner surface opposite the outer surface (see annotated Fig. 2 below), the second component including a fixation element (9) extending from the outer surface (see Fig. 2); and wherein the fixation element of the first component has a different shape than the fixation element of the second component (see Figs. 1-2).
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Regarding claim 2, wherein the fixation element of the first component comprises a spike (10) and the fixation element of the second component comprises a keel (9).
Claim(s) 1, 8-9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bertagnoli et al. (U.S. Pub. No. 2010/0217395 A1, hereinafter “Bertagnoli”).
Bertagnoli discloses, regarding claim 1, an implant (80, see Fig. 15) for insertion into an intervertebral disc space between two adjacent vertebrae (see Fig. 15), the implant comprising: a first component (88) having an outer surface (see annotated Fig. 15 below) for engaging one of the adjacent vertebrae (see Fig. 15) and an inner surface opposite the outer surface (see annotated Fig. 15 below), the first component including a fixation element (86) extending from the outer surface (see Fig. 15); a second component (84) having an outer surface for engaging the other of the adjacent vertebrae (see annotated Fig. 15 below) and an inner surface opposite the outer surface (see annotated Fig. 15 below), the second component including a fixation element (82) extending from the outer surface (see Fig. 15); and wherein the fixation element of the first component has a different shape than the fixation element of the second component (see Fig. 15, note that 82 is wider and shorter than 86).
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Regarding claim 8, wherein the fixation element of the first component comprises a keel (86, see Fig. 15) and the fixation element of the second component comprises a keel (82, see Fig. 15).
Regarding claim 9, wherein the fixation element of the first component comprises first and second keels laterally offset from a longitudinal axis of the implant (86, see annotated Fig. 15 above).
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) 3-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schneid, as applied to claim 1 above, and in view of Bertagnoli et al. (U.S. Pub. No. 2010/0217395 A1, hereinafter “Bertagnoli”).
Schneid discloses all of the features of the claimed invention, as previously set forth above. Schneid further discloses, regarding claim 3, wherein the fixation element of the first component comprises a spike (10, see Figs. 1-2). Schneid fails to explicitly disclose, regarding claim 3, wherein the fixation element of the second component comprises a first keel and a second keel; regarding claim 4, wherein the first and second keels are laterally offset from a longitudinal axis of the implant.
Bertagnoli discloses an implant (80, see Fig. 15) with a fixation element (86), wherein the fixation element comprises a first keel (86, see annotated Fig. 15 above) and a second keel (86, see annotated Fig. 15 above), wherein the first and second keels are laterally offset from a longitudinal axis of the implant (see annotated Fig. 15 above) in order to keep more vertebra intact along the central axis of the spine to create a stronger bone construct (see paras. [0055]-[0056]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the fixation element of the second component that comprises a keel in Schneid to comprise a first and second keel laterally offset from the longitudinal axis of the implant in view of Bertagnoli in order to keep more vertebra intact along the central axis of the spine to create a stronger bone construct.
Claim(s) 5-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schneid, as applied to claim 1 above, and in view of Marnay et al. (U.S. Pub. No. 2004/0117022 A1, hereinafter “Marnay”).
Schneid discloses all of the features of the claimed invention, as previously set forth above. Schneid further discloses, regarding claim 5, wherein the fixation element of the first component comprises a spike (10, see Figs. 1-2); and regarding claim 6, wherein the fixation element of the first component comprises a spike (10, see Figs. 1-2). Schneid fails to explicitly disclose, regarding claim 5, wherein the fixation element of the second component comprises a keel, wherein the keel comprises first and second ends, wherein the first end comprises a recess extending from the first end to a location between the first and second ends; regarding claim 6, wherein the fixation element of the second component comprises a keel, wherein the keel comprises a main body with first and second ends that extends along an axis of the endplate, wherein the first end flares laterally outward from the main body of the keel.
Marnay discloses an implant (10, see Fig. 1) having a fixation element that comprises a keel (16), the keel comprises a main body with first and second ends that extends along an axis of the endplate (see annotated Fig. 1 below), wherein the first end comprises a recess (17) extending from the first end to a location between the first and second ends (see annotated Fig. 1 below), wherein the first end flares laterally outward from the main body of the keel (18, see annotated Fig. 1 below, see also para. [0044]) in order to enable the keel to be firmly grasped by an insertion tool (see para. [0060]) and in order to better anchor the anterior end of the keel in the cutout in the vertebrae (see para. [0044]).
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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 keel in Schneid to include a recess and a first end that flares laterally outward in view of Marnay in order to enable the keel to be firmly grasped by an insertion tool and in order to better anchor the anterior end of the keel in the cutout in the vertebrae.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schneid, as applied to claim 1 above, and in view of Berger et al. (U.S. Pub. No. 2016/0228259 A1, hereinafter “Berger”).
Schneid discloses all of the features of the claimed invention, as previously set forth above. Schneid further discloses, regarding claim 7, wherein the implant has a longitudinal axis (see annotated Fig. 1 below) and the fixation element of the first component comprises a first set of spikes laterally offset from the longitudinal axis (see annotated Fig. 1 below). Schneid fails to disclose, regarding claim 7, wherein the implant has a second set of at least two spikes laterally offset from the longitudinal axis on an opposite side of the longitudinal axis.
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Berger discloses an implant (10, see Fig. 2), with a first component (22, see Fig. 11C), wherein the fixation element comprises with a first set of spikes (see annotated Fig. 11C below) and a second set of at least two spikes (see annotated Fig. 11C below) laterally offset from the longitudinal axis (see annotated Fig. 11C below) in order to enable the spikes to create their own tracks in the vertebral surface on each side of the implant to engage with bone and resist expulsion forces (see para. [0103]).
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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 fixation element of the first component in Schneid to include a second set of at least two spikes laterally offset from the longitudinal axis in view of Berger in order to enable the spikes to create their own tracks in the vertebral surface on each side of the implant to engage with bone and resist expulsion forces.
Claim(s) 10-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bertagnoli, as applied to claim 1 above, and in view of Marnay et al. (U.S. Pub. No. 2004/0117022 A1, hereinafter “Marnay”).
Bertagnoli discloses all of the features of the claimed invention, as previously set forth above. Bertagnoli further discloses, regarding claim 10, wherein the fixation element of the second component comprises a keel (82); regarding claim 11, wherein the fixation element of the second component comprises a keel (82). Bertagnoli fails to disclose, regarding claim 10, wherein the keel having a main body with first and second ends that extends along an axis of the endplate, wherein the first end flares laterally outward from the main body; and regarding claim 11, wherein the keel comprises first and second ends, wherein the first end comprises a recess extending from the first end to a location between the first and second ends.
Marnay discloses an implant (10, see Fig. 1) having a fixation element that comprises a keel (16), the keel comprises a main body with first and second ends that extends along an axis of the endplate (see annotated Fig. 1 above), wherein the first end comprises a recess (17) extending from the first end to a location between the first and second ends (see annotated Fig. 1 above), wherein the first end flares laterally outward from the main body of the keel (18, see annotated Fig. 1 above, see also para. [0044]) in order to enable the keel to be firmly grasped by an insertion tool (see para. [0060]) and in order to better anchor the anterior end of the keel in the cutout in the vertebrae (see para. [0044]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the keel in Bertagnoli to include a recess and a first end that flares laterally outward in view of Marnay in order to enable the keel to be firmly grasped by an insertion tool and in order to better anchor the anterior end of the keel in the cutout in the vertebrae.
Claim(s) 12-13, and 15-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schneid et al. (U.S. Pub. No. 2007/0260316 A1, hereinafter “Schneid”) in view of Guyer et al. (U.S. Pub. No. 2020/0214849 A1, hereinafter “Guyer”).
Schneid discloses, regarding 12, an implant (1, see Figs. 1-2) for insertion into an intervertebral disc space between two adjacent vertebrae (2-3, see Fig. 1), the implant comprising: a first component (4) having an outer surface (see annotated Fig. 2 above) for engaging one of the adjacent vertebrae (see Fig. 1) and an inner surface opposite the outer surface (see annotated Fig. 2 above), the first component including a fixation element (10) extending from the outer surface (see Fig. 2); a second component (5) having an outer surface (see annotated Fig. 2 above) for engaging the other of the adjacent vertebrae (see Fig. 1) and an inner surface opposite the outer surface (see annotated Fig. 2 above), the second component including a fixation element (9) extending from the outer surface (see Fig. 2); wherein the fixation element of the first component has a different shape than the fixation element of the second component (see Figs. 1-2).
Regarding claim 17, wherein the fixation element of the first component comprises a spike (10, see Fig. 2) and the fixation element of the second component comprises a keel (9, see Fig. 2).
Schneid fails to disclose, regarding claim 12, wherein the outer surface of one of the first and second components has a substantially domed shape; regarding claim 13, wherein the outer surface of the other of the first and second components is substantially flat; regarding claim 15, wherein the outer surface of the upper endplate extends from an anterior edge to a posterior edge opposite the anterior edge and is substantially convex from the anterior edge to the posterior edge; and regarding claim 16, wherein the outer surface of the upper endplate extends from a first lateral edge to a second lateral edge opposite the first lateral edge and is substantially convex from the first lateral edge to the second lateral edge.
Guyer discloses an implant (10, see Fig. 1) with a first component (100) with an outer surface (110) and a second component (200) with an outer surface (210), wherein the outer surface of the first component is substantially domed shaped (see Fig. 1), and the outer surface of the second component is substantially flat (see Fig. 1, see para. [0058]); wherein the outer surface of the upper endplate extends from an anterior edge to a posterior edge opposite the anterior edge (104, 108) and is substantially convex from the anterior edge to the posterior edge (110b, see Fig. 4, see para. [0053]); and wherein the outer surface of the upper endplate extends from a first lateral edge to a second lateral edge opposite the first lateral edge (114, 116) and is substantially convex from the first lateral edge to the second lateral edge (110a, see Fig. 3, see para. [0051]) in order to enable the outer surface of the first component to more closely conform to the natural concavity of the adjacent vertebral endplates to be fitted using less cutting or shaving of the vertebral endplates to inhibit migration of the implant without the intervertebral space (see para. [0053]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the outer surface of the first component in Schneid to be substantially domed shaped and be substantially convex between the anterior and posterior edge and between the first and second lateral edges in view of Guyer in order to in order to enable the outer surface of the first component to more closely conform to the natural concavity of the adjacent vertebral endplates to be fitted using less cutting or shaving of the vertebral endplates to inhibit migration of the implant without the intervertebral space.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schneid in view of Guyer, as applied to claim 12 above, and in further view of Arramon (U.S. Pub. No. 2013/0274880 A1, hereinafter “Arramon”).
Schneid in view of Guyer discloses all of the features of the invention, as previously set forth above, except regarding claim 14, wherein the outer surface of the other of the first and second components has a substantially domed shape.
Arramon discloses an implant (27, see Fig. 2C), wherein the outer surface (41) of the second component (35) has a substantially domed shape (see Fig. 2C, see para. [0025]) in order to enable the implant more accurately match the anatomy of the majority of patients while reducing the risk of unintended migration (see paras. [0025] and [0026]).
It would have been able to one having ordinary skill in the art at the time the invention was made to modify the outer surface of the second component in Schneid in view of Guyer to have a substantially domed shape in further view of Arramon in order to enable the implant more accurately match the anatomy of the majority of patients while reducing the risk of unintended migration.
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schneid in view of Guyer, as applied to claim 12 above, and in further view of Bertagnoli et al. (U.S. Pub. No. 2010/0217395 A1, hereinafter “Bertagnoli”).
Schneid in view of Guyer discloses all of the features of the claimed invention, as previously set forth above. Schneid in view of Guyer further discloses, regarding claim 18, wherein the fixation element of the first component comprises a spike (10, see Figs. 1-2). Schneid in view of Guyer fails to explicitly disclose, regarding claim 18, wherein the fixation element of the second component comprises a first keel and a second keel laterally offset from a longitudinal axis of the implant.
Bertagnoli discloses an implant (80, see Fig. 15) with a fixation element (86), wherein the fixation element comprises a first keel (86, see annotated Fig. 15 above) and a second keel (86, see annotated Fig. 15 above), wherein the first and second keels are laterally offset from a longitudinal axis of the implant (see annotated Fig. 15 above) in order to keep more vertebra intact along the central axis of the spine to create a stronger bone construct (see paras. [0055]-[0056]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the fixation element of the second component that comprises a keel in Schneid in view of Guyer to comprise a first and second keel laterally offset from the longitudinal axis of the implant in further view of Bertagnoli in order to keep more vertebra intact along the central axis of the spine to create a stronger bone construct.
Claim(s) 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schneid in view of Guyer, as applied to claim 12 above, and in further view of Marnay et al. (U.S. Pub. No. 2004/0117022 A1, hereinafter “Marnay”).
Schneid in view of Guyer discloses all of the features of the claimed invention, as previously set forth above. Schneid in view of Guyer further discloses, regarding claim 19, wherein the fixation element of the second component comprises a keel (9, see Figs. 1-2); and regarding claim 20, wherein the fixation element of the second component comprises a keel (9, see Figs. 1-2). Schneid in view of Guyer fails to explicitly disclose, regarding claim 19, wherein the keel comprises a main body with first and second ends that extends along an axis of the endplate, wherein the first end flares laterally outward from the main body of the keel; regarding claim 20, the keel comprises first and second ends, wherein the first end comprises a recess extending from the first end to a location between the first and second ends.
Marnay discloses an implant (10, see Fig. 1) having a fixation element that comprises a keel (16), the keel comprises a main body with first and second ends that extends along an axis of the endplate (see annotated Fig. 1 above), wherein the first end comprises a recess (17) extending from the first end to a location between the first and second ends (see annotated Fig. 1 above), wherein the first end flares laterally outward from the main body of the keel (18, see annotated Fig. 1 above, see also para. [0044]) in order to enable the keel to be firmly grasped by an insertion tool (see para. [0060]) and in order to better anchor the anterior end of the keel in the cutout in the vertebrae (see para. [0044]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the keel in Schneid in view of Guyer to include a recess and a first end that flares laterally outward in further view of Marnay in order to enable the keel to be firmly grasped by an insertion tool and in order to better anchor the anterior end of the keel in the cutout in the vertebrae.
Claim(s) 12-13, 15-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bertagnoli et al. (U.S. Pub. No. 2010/0217395 A1, hereinafter “Bertagnoli”) in view of Guyer et al. (U.S. Pub. No. 2020/0214849 A1, hereinafter “Guyer”).
Bertagnoli discloses, regarding 12, an implant (80, see Fig. 15) for insertion into an intervertebral disc space between two adjacent vertebrae (see Fig. 15), the implant comprising: a first component (88) having an outer surface (see annotated Fig. 15 above) for engaging one of the adjacent vertebrae (see Fig. 15) and an inner surface opposite the outer surface (see annotated Fig. 15 above), the first component including a fixation element (86) extending from the outer surface (see Fig. 15); a second component (84) having an outer surface (see annotated Fig. 15 above) for engaging the other of the adjacent vertebrae (see Fig. 15) and an inner surface opposite the outer surface (see annotated Fig. 15 above), the second component including a fixation element (82) extending from the outer surface (see Fig. 15); wherein the fixation element of the first component has a different shape than the fixation element of the second component (see Fig. 15, note that 82 is wider and shorter than 86).
Bertagnoli fails to disclose, regarding claim 12, wherein the outer surface of one of the first and second components has a substantially domed shape; regarding claim 13, wherein the outer surface of the other of the first and second components is substantially flat; regarding claim 15, wherein the outer surface of the upper endplate extends from an anterior edge to a posterior edge opposite the anterior edge and is substantially convex from the anterior edge to the posterior edge; and regarding claim 16, wherein the outer surface of the upper endplate extends from a first lateral edge to a second lateral edge opposite the first lateral edge and is substantially convex from the first lateral edge to the second lateral edge.
Guyer discloses an implant (10, see Fig. 1) with a first component (100) with an outer surface (110) and a second component (200) with an outer surface (210), wherein the outer surface of the first component is substantially domed shaped (see Fig. 1), and the outer surface of the second component is substantially flat (see Fig. 1, see para. [0058]); wherein the outer surface of the upper endplate extends from an anterior edge to a posterior edge opposite the anterior edge (104, 108) and is substantially convex from the anterior edge to the posterior edge (110b, see Fig. 4, see para. [0053]); and wherein the outer surface of the upper endplate extends from a first lateral edge to a second lateral edge opposite the first lateral edge (114, 116) and is substantially convex from the first lateral edge to the second lateral edge (110a, see Fig. 3, see para. [0051]) in order to enable the outer surface of the first component to more closely conform to the natural concavity of the adjacent vertebral endplates to be fitted using less cutting or shaving of the vertebral endplates to inhibit migration of the implant without the intervertebral space (see para. [0053]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the outer surface of the first component in Bertagnoli to be substantially domed shaped and be substantially convex between the anterior and posterior edge and between the first and second lateral edges in view of Guyer in order to in order to enable the outer surface of the first component to more closely conform to the natural concavity of the adjacent vertebral endplates to be fitted using less cutting or shaving of the vertebral endplates to inhibit migration of the implant without the intervertebral space.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bertagnoli in view of Guyer, as applied to claim 12 above, and in further view of Arramon (U.S. Pub. No. 2013/0274880 A1, hereinafter “Arramon”).
Bertagnoli in view of Guyer discloses all of the features of the claimed invention, as previously set forth above except, regarding claim 14, wherein the outer surface of the other of the first and second components has a substantially domed shape.
Arramon discloses an implant (27, see Fig. 2C), wherein the outer surface (41) of the second component (35) has a substantially domed shape (see Fig. 2C, see para. [0025]) in order to enable the implant more accurately match the anatomy of the majority of patients while reducing the risk of unintended migration (see paras. [0025] and [0026]).
It would have been able to one having ordinary skill in the art at the time the invention was made to modify the outer surface of the second component in Bertagnoli in view of Guyer to have a substantially domed shape in further view of Arramon in order to enable the implant more accurately match the anatomy of the majority of patients while reducing the risk of unintended migration.
Claim(s) 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bertagnoli in view of Guyer, as applied to claim 12 above, and in further view of Marnay et al. (U.S. Pub. No. 2004/0117022 A1, hereinafter “Marnay”).
Bertagnoli in view of Guyer discloses all of the features of the claimed invention, as previously set forth above. Bertagnoli in view of Guyer further discloses, regarding claim 19, wherein the fixation element of the second component comprises a keel (82, see Fig. 15); and regarding claim 20, wherein the fixation element of the second component comprises a keel (82, see Fig. 15). Bertagnoli in view of Guyer, fails to disclose regarding claim 19, the keel having a main body with first and second ends that extends along an axis of the endplate, wherein the first end flares laterally outward from the main body; and regarding claim 20, the keel having first and second ends, wherein the first end comprises a recess extending from the first end to a location between the first and second ends.
Marnay discloses an implant (10, see Fig. 1) having a fixation element that comprises a keel (16), the keel comprises a main body with first and second ends that extends along an axis of the endplate (see annotated Fig. 1 above), wherein the first end comprises a recess (17) extending from the first end to a location between the first and second ends (see annotated Fig. 1 above), wherein the first end flares laterally outward from the main body of the keel (18, see annotated Fig. 1 above, see also para. [0044]) in order to enable the keel to be firmly grasped by an insertion tool (see para. [0060]) and in order to better anchor the anterior end of the keel in the cutout in the vertebrae (see para. [0044]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the keel in Bertagnoli in view of Guyer to include a recess and a first end that flares laterally outward in further view of Marnay in order to enable the keel to be firmly grasped by an insertion tool and in order to better anchor the anterior end of the keel in the cutout in the vertebrae.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michelle C. Green whose telephone number is (571)270-7051. The examiner can normally be reached on Monday-Friday between 9am-5pm.
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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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/M.C.G/ Examiner, Art Unit 3773 /EDUARDO C ROBERT/ Supervisory Patent Examiner, Art Unit 3773
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