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 Objections
Claim 1 is objected to because of the following informalities:
Regarding claim 1, “the device” should be “the implant”. Additionally, “a first vertebrae” should be “a first vertebra”. Additionally, “a second, adjacent vertebrae” should be “a second, adjacent vertebra”.
Appropriate correction is required.
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.
Claims 1, 3, 9-12, and 26 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Application Publication No. 2019/0117410 (Parry).
Regarding claim 1, Parry discloses a dynamic spinal implant (100, see Figs. 2A-2F shown below) configured to be inserted between two adjacent vertebrae (see paragraph [0010], e.g.), the device comprising: a first endplate (116) configured to contact the inferior face of a first vertebrae (see paragraph [0010]); a second endplate (114) substantially opposite the first endplate and configured to contact the superior face of a second, adjacent vertebrae (see paragraph [0010]); an inner structure (142) disposed between the first endplate and the second endplate (see Figs. 2A-2F and paragraph [0104]); and a bone graft or bone substitute material disposed within the dynamic spinal implant (see paragraphs [0103]; bone graft disposed in opening 124), wherein the inner structure is configured to generate a modified strain tensor on the bone graft and/or bone substitute material disposed within the dynamic spinal implant (see paragraphs [0098], [0104], and [0107]; strain on bone graft is modified by the inner structure to minimize risk of stress shielding and promote mechanical stimulus of the graft material in line with Wolff’s law), wherein the inner structure is configured to modify a mechanical load to promote bone growth within the inner structure (see paragraphs [0098] and [0106]; inner structure promotes a mechanical load stimulus and promotes bone growth).
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Regarding claim 3, Parry discloses wherein at least a portion of the inner structure includes a vibrational mode that resonates with the mechanical load (all objects, including the inner structure, inherently have a resonant frequency; thus, the inner structure will vibrate when the mechanical load matches the resonant frequency of the inner structure).
Regarding claim 9, Parry discloses wherein the dynamic spinal implant comprises at least one resonating element (all objects, including the implant and its constituent parts, inherently have a resonant frequency; thus, the implant is entirely comprised of elements capable of resonating).
Regarding claim 10, Parry discloses wherein the dynamic spinal implant further comprises at least one free resonator (all objects, including the implant and its constituent parts, inherently have a resonant frequency; thus, the implant is entirely comprised of parts that are free to resonate). .
Regarding claim 11, Parry discloses wherein the dynamic spinal implant comprises a first resonating element having a first axis of motion, and a second resonating element having a second axis of motion different from the first axis of motion (the inner structure lattice has struts having different longitudinal axis along which they can vibrate at their resonant frequency, see marked-up Fig. 4 below, for example).
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Regarding claim 12, Parry discloses wherein the dynamic spinal implant comprises a resonating element having a first axis of motion, and a free resonator having a second axis of motion different than the first axis of motion (the inner structure lattice has struts having different longitudinal axis along which they are free to vibrate at their resonant frequency, see marked-up Fig. 4 above, for example).
Regarding claim 26, Parry discloses further comprising a side wall (120) disposed between the first endplate and the second endplate.
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.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Parry in view of U.S. Patent Application Publication No. 2019/0046331 (Walsh).
Regarding claim 6, Parry fails to disclose wherein the inner structure is configured to focus the mechanical load toward or away from a predetermined location within the inner structure. However, Walsh discloses an intervertebral implant (1) in which an inner structure is situated to redirect load toward or away from a predetermined location within the inner structure, such as toward a bone graft (see paragraph [0008]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the implant of Parry to focus mechanical load toward a predetermined location, such as a bone gragt, as suggested by Walsh in order to provide benefits such as facilitating bone remodeling and new bone formation, limiting hotspots, reducing subsidence of the graft material, etc. (see Walsh, paragraph [0076]).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Parry in view of U.S. Patent Application Publication No. 2016/00081809 (Schneider).
Regarding claim 14, Parry fails to disclose wherein the inner structure comprises a plurality of orthorhombic body-centered repeating units. However, Parry discloses the inner structure comprising a plurality of body-centered repeating units (see paragraph [0097]). Additionally, Schneider discloses a bone fusion implant (see Abstract) in which the implant has a lattice microstructure of orthorhombic units (see paragraph [0076]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to have the repeating units of Parry be a plurality of orthorhombic body-centered repeating units as suggested by Schneider as Schneider suggests an orthorhombic shape is a suitable shape for a bone fusion implant lattice unit, and such a modification merely involves substituting one known lattice unit shape for another known lattice unit shape without any unpredictable results.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Parry in view of U.S. Patent Application Publication No. 2018/0280145 (Jones).
Regarding claim 16, Parry fails to disclose wherein the inner structure comprises at least one of: a plurality of dode-thin lattice repeating units, a plurality of diamond lattice repeating units, a plurality of auxetic lattice repeating units, or a plurality of S-shaped lattice repeating units. However, Parry discloses the inner structure comprising a plurality of repeating units (see paragraph [0097]). Additionally, Jones discloses a vertebral bone fusion implant (see paragraph [0041]) in which the implant has a lattice structure of diamond units (see paragraph [0049]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to have the repeating units of Parry be a plurality of diamond lattice repeating units as suggested by Jones as Jones suggests a diamond shape is a suitable shape for a bone fusion implant lattice unit, and such a modification merely involves substituting one known lattice unit shape for another known lattice unit shape without any unpredictable results.
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Parry in view of U.S. Patent Application Publication No. 2019/0231555 (Neubardt).
Regarding claim 24, Parry fails to explicitly disclose wherein the strain tensor generated by the dynamic spinal implant causes fusion of the adjacent vertebrae faster than a static spinal implant. However, Parry discloses strain on bone graft is modified by the inner structure to minimize risk of stress shielding and promote mechanical stimulus of the graft material in line with Wolff’s law (see paragraphs [0098], [0104], and [0107]). Additionally, Neubardt discloses that bone heals faster and more reliably when under compression according to Wolff’s Law (see paragraph [0136]). Thus, one of ordinary skill in the art would have recognized that the strain tensor generated by the dynamic spinal implant of Parry causes fusion of the adjacent vertebrae fasten than a static spinal implant, as the dynamic implant of Parry promotes mechanical stimulus of the graft material in line with Wolff’s law, which allows the bone growth fusion to happen faster than in a static implant that does not utilize mechanical stimulus of a bone graft.
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Parry in view of U.S. Patent Application Publication No. 2016/0030194 (Ledet).
Regarding claim 25, Parry fails to explicitly disclose wherein, after implantation between two adjacent vertebrae of a subject, the dynamic spinal implant imparts a strain on surrounding tissue of at least about 8%. However, Ledet discloses an intervertebral cage implanted between two adjacent vertebrae that prevents stress shielding and imparts a strain on surrounding bone of about 2% to 10% (see paragraph [0053]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the implant of Parry to impart a strain on surrounding tissue of about 8% after implantation between two adjacent vertebrae in order to prevent stress shielding (see Ledet, paragraph [0053]), and because in cases where claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. See In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Claims 27-29 are rejected under 35 U.S.C. 103 as being unpatentable over Parry in view of U.S. Patent No. 6,136,031 (Middleton).
Regarding claims 27-29, Parry fails to disclose further comprising a slit disposed on the side wall such that the dynamic spinal implant enables a strain tensor component along its z-axis that is greater than a strain tensor component enabled along its x-axis and that is greater than a strain tensor component enabled along its y-axis (claim 27); wherein the slit is disposed proximal to a fixation area of the side wall (claim 28); wherein the slit is disposed proximal to an instrument interface area (claim 29). However, Middleton discloses an intervertebral implant (500) that comprises slits (512) disposed on the side wall of the implant such that the implant enables a strain tensor component along its z-axis that is greater than a strain tensor component enabled along its x-axis and that is greater than a strain tensor component enabled along its y-axis (see Fig. 10B and col. 6, lines 14-23; greater strain tensor component is enabled by the slits along the z-axis, i.e. height, of the implant to facilitate loading of graft packed within the cage). The slits of Middleton are disposed entirely circumferentially around the side wall of the implant (see Figs. 4-10B). Thus, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to have slits disposed along the entire side wall of the implant of Parry, including proximal to a fixation area or instrument interface area of the implant, in order to facilitate loading of graft material packed within the cage (see Middleton, col. 6, lines 14-23).
Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Parry in view of U.S. Patent Application Publication No. 2001/0016774 (Bresina).
Regarding claim 30, Parry fails to disclose wherein the dynamic spinal implant resists compression along its z-axis at a first resistance level for a first compression distance along the z-axis, and resists compression along its z-axis at a second, greater resistance level for a second compression distance along the z-axis. However, Bresina discloses an intervertebral implant (1) that resists compression along is z-axis (2) at a first resistance level for a first compression distance along the z-axis, and resists compression along its z-axis at a second, greater resistance level for a second compression distance along the z-axis (see paragraph [0040]; first resistance level at a first compression distance before the slots are closed is less than second resistance level at a second compression distance after the slots are closed). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the implant of Parry to be configured to resist compression as suggested by Bresina in order to allow ideal strain levels to be attained in an enclosed graft material under minimal loads, while at the same time, protecting the graft from high strains that can lead to mechanical failure of the graft (see Bresina, paragraph [0016]).
Claims 31-33 are rejected under 35 U.S.C. 103 as being unpatentable over Parry in view of U.S. Patent Application Publication No. 2012/0303128 (Ulrich).
Regarding claim 31, Parry discloses a method of promoting intervertebral bone growth in a subject, the method comprising: inserting a dynamic interbody fusion device (100) of any one preceding claim (dynamic interbody fusion device of claim 1, see analysis of claim 1 above) between two adjacent vertebrae (see paragraph [0010], e.g.).
Further regarding claim 31, Parry appears to disclose applying a mechanical load to the dynamic interbody fusion device for a period of time sufficient to promote bone growth (see paragraph [0005], patient’s weight exerted on intervertebral implants after implantation; see paragraphs [0170] and [0183], load bearing areas of implant; see Abstract and paragraphs [0011]-[0023] and [0098], promotion of bone growth). Additionally, Ulrich discloses a method of using an intervertebral implant in which bone growth is promoted while a mechanical load is applied to the intervertebral implant over a period of time (see paragraphs [0130], [0154], and [0172]). Regarding claims 32 and 33, Ulrich discloses wherein the mechanical load is applied by walking movement of the subject (see paragraph [0172]; load is applied by the subject walking). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the method of Parry to apply a mechanical load by patient walking over a period of time sufficient to promote bone growth, as Parry suggests applying a load to an intervertebral implant helps promote strong bone growth via Wolff’s law (see Parry, paragraph [0098]), and Ulrich suggests a patient walking applies a load to an implanted intervertebral implant while new bone growth is promoted (see Ulrich, paragraphs [0130], [0154], and [0172]).
Conclusion
See PTO-892 for prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Example of relevant references are:
The Hibri references that suggests redirecting loads placed on intervertebral implants.
The Lutz reference that suggests redirecting loads placed on intervertebral implants.
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/NICHOLAS J PLIONIS/Primary Examiner, Art Unit 3773