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 .
Election/Restrictions
Applicant’s election without traverse of Species IV, shown in Figs. 25-30 in the reply filed on 05/22/2026 is acknowledged. Claims 42-61 are pending.
Claim Objections
Claims 42-61 are objected to because of the following informalities:
The dependency of claims 47 and 48 can’t be determined. For purposes of examination claims 47 and 48 depend from claim 45. Since claims 49, 50 and 52 depend from one of claim 47 or 48 the proper dependency can’t be determined. Appropriate correction is required.
In claim 42, line 4, remove the dash between “the” and “vertebral.”
In claim 44, line 2, change “blocs” to --blocks--.
In claim 49, line 2, delete “which”.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 42-61 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 42 includes the recitation “after said moving the bulk blocks filling up at least a part of the volume of the intraosseous cavity lying outside the non-expanded shape of the intra-vertebral support device.” The recitation is indefinite as it lacks any reference to the filling material. Additionally, lines 11-12 contradict the previous expansion step (lines 5-10) because line 11 first recites “after said moving the bulk blocks,” but references the non-expanded shape of the intra-vertebral support device. The specification and drawings support a maintained expanded shape once expanded.
Claim 52 recites the limitation "the access passage" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 54 includes the recitation that each bulk block is comb-shaped and provided with a plurality of ribs. It is noted that the specification identifies the ribs as element 49 (see Fig. 25). The upper block does not have any identified rib. Furthermore, the elected embodiment does not have a described comb-shape as claimed. The Specification and Drawings lack any reference to the claimed shape.
Claim 60 also claims ribs located on each of the blocks. As noted above, the elected embodiment discloses ribs 49 – only shown in Fig. 25 and only located on the lower block. The claimed structure of claim 60 is therefore indefinite and not supported by the specification or drawings.
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) 42-50, 53, 55-58 and 61 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Olmos et al. (U.S. 2017/0290674 A1).
Concerning claim 42, Olmos et al. disclose a method of vertebral surgery on a human or non-human mammal, comprising: positioning an expandable intra-vertebral support device in an intra-osseous cavity in a vertebra of the mammal (see Fig. 1 and par. 0073), the intra-vertebral support device being in a non-expanded state in which the-vertebral support device has a non-expanded shape;
expanding the intra-vertebral support device positioned in the intra-osseous cavity from the non-expanded state into an expanded state in which the intra-vertebral support device supports the vertebra and resists a load acting on the vertebra (see Fig. 2), said expanding comprising: moving at least two bulk blocks (see Fig. 16B, elements 202 and 204) of the intra-vertebral support device along a pre-
defined path to project out in the expanded state relative to the non-expanded shape of the intra-vertebral support device; and after said moving the bulk blocks filling up at least a part of the volume of the intra- osseous cavity lying outside the non-expanded shape of the intra-vertebral support device (see par. 0073).
Concerning claim 43, wherein: each bulk block (see Fig. 16B, elements 202 and 204 – outer surfaces of the upper and lower body portions that engage and bear load against the vertebral endplates) comprises a bone side surface on which the load acts after moving said least two bulk blocks; and the intra-vertebral support device provides support to bone material present between the bone side surface and the outside of the vertebra after said expanding. Upon expansion, the implant supports the vertebral endplates and the surrounding bone structure.
Concerning clam 44, wherein the device comprises at least one pair of bulk blocks in which the bone side surface of a first bulk block (see Fig. 16B, element 202) of the pair of bulk blocks contacts a wall of the cavity opposite to a wall of the cavity contacted by the bone side surface of a second bulk block (see Fig. 16B, element 204) of the pair of bulk blocks (see Fig. 2). Olmos discloses upper and lower body portions whose outer bone-contacting surfaces engage opposing vertebral endplates, i.e., opposite walls of the intervertebral/intraosseous space).
Concerning claim 45, wherein upon expanding (see Fig. 2) the intra-vertebral support device pushes bone material away from the cavity and at least partially restores a height of the vertebra. Olmos discloses that expansion of the upper and lower body portions separates the vertebral endplates, thereby restoring disc and/or vertebral body height, which inherently involves displacing bone and soft tissue material.
Concerning claim 46, comprising inhibiting the intra-vertebral support device from collapsing from the expanded state into the non-expanded state, said inhibiting comprising securing a position of the bulk blocks in the expanded state. Olmos’ actuator shaft, once advanced, retains the upper and lower body portions in the expanded position, and the wedge/protrusion mechanism inherently resists collapse under load (see par. 0169)
Concerning claim 47, wherein said securing the position of the bulk blocks comprises holding the bulk blocks in position against the load (see par. 0169).
Concerning claim 48, wherein the intra-vertebral device comprises a fixation (see Fig. 18, element 206) and the method comprises inhibiting at least two of the bulk blocks from being moved towards each other by the load, the inhibiting comprising positioning the fixation between said at least two of the bulk blocks (see par. 0169).
Concerning claim 49, wherein the fixation comprises at least one fixation block (see Fig. 18, element 206) and the method comprises translationally moving the fixation block which in an axial direction of the intra-vertebral support device, and exerting by said translationally moving a force on the bulk block which pushes the bulk blocks in a direction of expansion perpendicular to the axial direction (see Figs. 1 and 2).
Concerning claim 50, comprising rotating a rod (see Fig. 18, element 210) which extends through the at least one fixation block (206) and thereby actuating a translational movement of the fixation block in the axial direction, the rod retains the fixation block in position in the longitudinal direction of the rod when not rotating. Olmos expressly discloses an actuator shaft that is rotated to drive axial translation of the fixation blocks, and when rotation ceases, the shaft retains the protrusions in their axial position by virtue of the threaded engagement.
Concerning claim 53, wherein: said bulk blocks comprise at least one expandable pair of bulk blocks (see Fig. 16A, elements 202 and 204) in which a first bulk block (202) of the expandable pair of bulk blocks extends in the non-expanded state through a second bulk block (204) of the expandable pair of bulk blocks; and the first bulk block (202) moves at least partially out of the second bulk block (204) and the combined shape of the expandable pair is changed when the intra-vertebral support device is brought into the expanded state (see Fig. 16B).
Concerning claim 55, wherein the first bulk block comprises a first matrix of open cells and the second bulk block comprises a second matrix of open cells (see par. 0132 – implant formed from open cell foam material); wherein in the non-expanded state the first matrix has a first overlapping part which extends through at least a second overlapping part of the second matrix (see Fig. 20B, element 242; and Fig. 21A, element 240); and wherein, when expanding the intra-vertebral support device, the first matrix and the second matrix are moved relative to each other such that a size of the first overlapping part and the second overlapping part is reduced (see Fig. 18).
Concerning claim 56, comprising osseo-incorporating the intra-vertebral support device into the vertebra. Olmos discloses that the implant is a spinal fusion device, and fusion, i.e., osseointegration of the implant with the vertebral endplates and surrounding bone is the express purpose of the device and an inherent result of its implantation.
Concerning claim 57, as best understood, wherein each of said bulk blocks is movably attached via a form-closed connection to an intermediate object (actuator shaft assembly) located in the expanded state between the bulk blocks. Olmos discloses the upper and lower body portions being mechanically coupled to and guided by the actuator shaft assembly, which is the intermediate fixating element positioned between the bulk blocks in the expanded state. The form-closed connection is provided by the side portions and wedge surface engagement.
Concerning claim 58, wherein the intra-vertebral support device (see Figs. 16A-19) comprises a device body with an, exposed, exterior surface and each bulk block (202 and 204) forms a partial device body of the intra-vertebral support device; and wherein each of said bulk blocks comprises: an inside facing another of said bulk blocks, and a bone side surface, facing away from the other of said bulk blocks, the bone side surface forming in the non-expanded state (see Fig. 16A) part of the exposed exterior surface of the device body; and wherein said moving at least two bulk blocks comprises moving the bone side surface relative to the exposed exterior surface of the device body (see Fig. 16B). Olmos discloses that the upper and lower body portions each have an outer bone contacting surface that forms part of the overall device exterior in both collapsed and expanded states, and expansion moves these surfaces outward relative to the device body as a whole.
Concerning claim 61, wherein the intra-vertebral support device comprises a device body with an, exposed, exterior surface, the device body having an elongated shape (see Fig. 16B).
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) 51, 52 and 59 is/are rejected under 35 U.S.C. 103 as being unpatentable over Olmos et al. (U.S. 2017/0290674 A1).
Concerning claim 51, wherein the intra-osseous cavity is surgically made through an access passage and the method comprises inserting the intra-vertebral support device into the intra-osseous cavity through the access passage. Olmos discloses that the implant is inserted through a surgical approach into the prepared space. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that in an intravertebral application, the cavity would be created through a defined access passage such as a transpedicular channel, as this was standard surgical technique for intravertebral expandable implant delivery.
Concerning claim 52, wherein in the expanded state a diameter of the intra-vertebral support device in a direction of expansion is larger than the diameter of the access passage, and the intra-vertebral support device is inserted with the direction of expansion oriented perpendicular to the longitudinal direction of the access passage. Olmos discloses that the implant is inserted in a low-profile, non-expanded configuration with a height less than the expanded height, meaning the expanded dimension exceeds the insertion dimension. The direction of expansion is perpendicular to the longitudinal axis of insertion. For minimally invasive surgeries it is obvious to form the access passage just large enough to pass the smallest dimension of the implant therethrough.
Concerning claim 59, wherein each of said bone side surfaces has an elongated shape (see Fig. 16B below) which extends from a first transversal end of the bone side surface to a second, opposite transversal end of the bone side surface, with lateral edges (see Fig. 16B below) between the transversal ends defining respective lateral sides of the bone side surface, and the bone side surfaces are curved around a longitudinal axis extending in the direction of the first transversal end towards the second transversal end (it is noted that all edges of implant are curved). For a complete prosecution the examiner will also note that it would have been an obvious matter of design choice to one skilled in the art before the effective filing date of the claimed invention to construct the upper and lower blocks with a more rounded top, since applicant has not disclosed that such solve any stated problem or is anything more than one of numerous shapes or configurations a person ordinary skill in the art would find obvious for the purpose of fusing adjacent vertebrae. In re Dailey and Eilers, 149 USPQ 47 (1966). Curvature of the bone side surfaces around a longitudinal axis would have been obvious to one of ordinary skill in the art as a routine anatomical contouring feature well-known in the expandable interbody implant art to conform to the curvature of the vertebral endplate and improve load distribution and endplate contact.
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Conclusion
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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