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 Group I and Species 4, shown in Figs. 25-30 in the reply filed on 05/29/2026 is acknowledged. Claims 1-21 are pending.
Claim 21 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claim 16 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
Claim Objections
Claim 13 is objected to because of the following informalities:
In claim 13, line 12, insert --block-- after “second fixation.” Appropriate correction is required.
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) 1-5, 8-15 and 20 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 1, Olmos et al. disclose an implantable expandable intra-vertebral support device (see Fig. 1, and par. 0073), the device having an expanded state (see Fig. 2) and a non-expanded state (see Fig. 1), the device comprising: a device body with an outer surface, the device body comprising at least two pre-shaped bulk blocks (see Fig. 16B, elements 202 and 204) which in the non-expanded state (see Fig. 16A) extend through each other and which are movable out of each other in order to project in the expanded state (see Fig. 16B) relative to the outer surface in the non-expanded state; each pre-shaped bulk block comprising: a load supporting surface for supporting in the expanded state a load acting on a vertebra, the load supporting surface forming in the non-expanded state a part of the outer surface of the device body, and a bulk volume, which in the non-expanded state is inside the device body; the pre-shaped bulk blocks comprising a first pre-shaped bulk block (202) and a second pre-shaped bulk block (204), which first pre-shaped bulk block is oriented in the expanded state with its load supporting surface facing away from the load supporting surface of the second pre-shaped bulk block; the first pre-shaped bulk block being movable to project out in the expanded state, along a first predefined path, the second pre-shaped bulk block being movable to project out in the expanded state, along a second predefined path, the first predefined path differing from the second predefined path;
a fixation (see Fig. 16B, elements 206 and 208) for inhibiting the device from collapsing in the expanded state back into the non-expanded state under the load, the fixation securing in the expanded state a position of said pre-shaped bulk blocks on the predefined path; an actuator ((210) for actuating transferring the device from the non-expanded state into the expanded state, the actuator extending through an inside of the device body (see Fig. 18), which actuator is configured to actuate the movement of the bulk blocks away from each other along the respective predefined paths, to take the pre-shaped bulk blocks out of each other.
Concerning claim 2, wherein the device is dimensioned for percutaneous placement in the vertebra (see Fig. 0065).
Concerning claim 3, wherein in the non-expanded state (see Fig. 16A) the pre-shaped bulk blocks are positioned interdigitated with each other, and the pre-shaped bulk blocks are movable to take the mutually interdigitated parts out of each other (see Fig. 16B).
Concerning claim 4, wherein the first pre-shaped bulk block has a bulk volume which is partitioned into slots (see Fig. 16A below) and the second pre-shaped bulk block comprises panel-shaped elements (see Fig. 16A below) which in the non-expanded state are admitted in the slots.
[AltContent: connector][AltContent: textbox (Panel shaped elements)][AltContent: textbox (Slot (2nd slot located on opposite of implant))][AltContent: arrow]
PNG
media_image1.png
589
619
media_image1.png
Greyscale
Concerning claim 5, wherein the first pre-shaped bulk block comprises ribs (see Figs. 20A and 20B, element 242) which partition at least a part of the bulk volume into said slots, the ribs guiding a movement of the panel-shaped elements of the second pre-shaped bulk block admitted in the slots out of said slots, during expansion of the device from the non-expanded state into the expanded state.
Concerning claim 8, wherein the actuator (210) engages on the fixation (206 and 208) to actuate a movement of the fixation and the fixation engages on the pre-shaped bulk blocks to drive a movement of the pre-shaped bulk blocks, when the device transitions from the non- expanded state to the expanded state.
Concerning claim 9, wherein: the fixation comprises at least one fixation block (206) which is movable by the actuator (210) in a moving direction into an interstitial space between the pre-shaped bulk blocks; said at least one fixation block (206) inhibits, when located in the interstitial space, the pre- shaped bulk blocks from moving towards each other; and which fixation block is configured to exert when moving into the interstitial space a force on the pre-shaped bulk blocks in a direction of expansion transverse to the moving direction which force pushes the pre-shaped bulk blocks out of each other.
Concerning claim 10, wherein: said at least one fixation block comprises at least two fixation blocks (206 and 208), the at least two fixation blocks comprising: a first fixation block positioned which, seen in the moving direction, at a first position and a second fixation block positioned at a second position in the non-expanded state; at least one of said at least two fixation blocks are movable by the actuator (210) in the moving direction to change a distance between the first fixation block and the second fixation block; and in the expanded state the fixation blocks are positioned in the interstitial space and maintain a separation between the pre-shaped bulk blocks (see Figs. 16A and 16B).
Concerning claim 11, wherein: each of said pre-shaped bulk blocks comprises a central slot (see Fig. 19, receiving element 210) which extents, in the longitudinal direction of the device body, from a first axial end of the central slot to a second axial end at an opposite side of the central slot; the central slots of the pre-shaped bulk blocks form in the non-expanded state a longitudinal passage through the device body which is located between the pre-shaped bulk blocks; and the actuator extends in the non-expanded state through the longitudinal passage.
Concerning claim 12, wherein: the fixation comprises at least two fixation blocks (see Fig. 18, elements 206 and 208) which, seen in a longitudinal direction of the longitudinal passage, are spaced apart in the non-expanded state, the at least two fixation blocks comprising a first fixation block (206) positioned at a first side of the pre-shaped bulk blocks and a second fixation block (208) positioned in the non-expanded state at a second side of the pre-shaped bulk blocks, which second side is, seen in the longitudinal direction, opposite to the first side; which at least two fixation blocks are movable by the actuator (210) in the longitudinal direction into an interstitial space between the pre-shaped bulk blocks, each fixation block is configured to exert a force on the pre-shaped bulk blocks in a direction of expansion transverse to the longitudinal direction when moving into the interstitial space, which force pushes the pre-shaped bulk blocks out of each other; the actuator retains, at least in the expanded state, the fixation blocks in position relative to each other, when the at least two fixation blocks are positioned in the interstitial space, the at least two fixation blocks maintain a separation between the pre-shaped bulk blocks.
Concerning claim 13, wherein said at least one fixation block comprises a first fixation block (see Fig. 18, element 206) positioned at a first side of the pre-shaped bulk blocks and a second fixation block (see Fig. 18, element 208) positioned at a second side of the pre-shaped bulk blocks, which second side is, seen in a longitudinal direction of the longitudinal passage, opposite to the first side; the fixation blocks are in the expanded state positioned in an interstitial space between the pre-shaped bulk blocks and maintain a separation between the pre-shaped bulk blocks; and the first fixation block and the second fixation block are movable relative to each other in the longitudinal direction by the actuator (210), the actuator comprising a rod which extends through the passage, which rod is in threaded (210) engagement with at least one of the first fixation block and the second fixation block to actuate a translational movement along the rod of the engaged fixation block upon a rotation of the rod around an axis extending in the longitudinal direction (see par. 0153).
Concerning claim 14, wherein: the first fixation block (208) remains in the longitudinal direction in position relative to the rod upon the rotation of the rod; and the rod is in threaded engagement (210) with the second fixation block (206) and upon the rotation of the rod the fixation block moves over the rod towards the first fixation block.
Concerning claim 15, wherein at least one fixation block (206) comprises a base with a base passage (see Fig. 19, receiving element 210) which extends through the base, which base passage lies in the non-expanded state in the prolongation of the longitudinal passage, and wherein the rod (210) extends through the base passage.
Concerning claim 20, wherein a longitudinal passage (see Fig. 19, receiving element 210) extends through the device body in the non-expanded state, which longitudinal passage is located between the pre-shaped bulk blocks, the passage having a first opening at a first side of the bulk blocks and a second opening at a second side of the bulk blocks , which first side is seen in the longitudinal direction of the passage opposite to the second side; the actuator comprises a rod (210) which extends through the passage between the pre-shaped bulk blocks (202 and 204), and which rod projects with a first axial end through the first opening and with a second axial end through the second opening, which rod is rotatable in the passage around a longitudinal axis of the rod relative to the pre-shaped bulk blocks (see par. 0153); the fixation comprises a first fixation block (208) mounted on the rod (210) at the first side and a second fixation block (206) mounted on the rod at the second side, the rod engaging on the first fixation block and the second fixation block to convert a rotational motion of the rod around the longitudinal axis into a linear motion along the longitudinal axis of at least one of the first fixation block and the second fixation block (see Figs. 16A and 16B); the first pre-shaped bulk block (206) is attached with a first attachment to the rod, and the first pre-shaped bulk block is movable relative to the rod in a first radial direction transverse to the longitudinal axis with a maximum displacement of the first pre-shaped bulk block relative to the rod determined by the first attachment; the second pre-shaped bulk block (208) is attached with a second attachment to the rod, and the second pre-shaped bulk block is movable relative to the rod in a second radial direction transverse to the longitudinal axis with a maximum displacement of the second pre-shaped bulk block relative to the rod determined by the second attachment; the first fixation block and the second fixation block engage with an interstitial space side of the first pre-shaped bulk block and of the second pre-shaped bulk block, the interstitial space side defining in the expanded state a side of an interstitial space between the first pre-shaped bulk block and the second pre-shaped bulk block; at least one of the first fixation block and the second fixation block cooperates with the interstitial space side to exert, when moving along the longitudinal axis of the rod, a first force in the first radial direction on the first pre-shaped bulk block and a second force in the second radial direction on the second pre-shaped bulk block, which first force and second force push the pre-shaped bulk blocks out of each other (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) 6-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Olmos et al. (U.S. 2017/0290674 A1) in view of Abernathie (US 20060212118 A1).
Olmos et al. disclose the invention substantially as described above. However, Olmos et al. do not explicitly disclose that the device body has a tubular shape with a longitudinal axis, and the device body is which is curved in a transversal direction, around the longitudinal axis; the load supporting surface extends in a longitudinal direction parallel to the longitudinal axis, from a first transversal end of the load supporting surface to a second, opposite transversal end of the load supporting surface; the load supporting surface has lateral edges extending between the transversal ends which define respective lateral sides of the pre-shaped bulk block, which lateral edges are in the non-expanded state flush with the outer surface of the device body, wherein the load supporting surface of at least one of the pre-shaped bulk blocks is curved in a transversal direction transverse to the longitudinal direction.
Abernathie disclose a tubular shaped expandable intra-vertebral support device in the same field of endeavor for the purpose of preserving or restoring proper lordotic or kyphotic curvature of the spine.
It would have been an obvious matter of design choice to one skilled in the art at the time the invention was made form Abernathie’s implant in a tubular shape, since applicant has not disclosed that such solves any stated problem or is anything more than one of numerous shapes or configurations a person of ordinary skill in the art before the effective filing date of the claimed invention would find obvious for the purpose of inserting the implant through a tubular/cannulated retractor system, improve load distribution, or allow self-centering during placement, or simply as a known alternative cage geometry suited to the same surgical approach. In re Dailey and Eilers, 149 USPQ 47 (1966).
Allowable Subject Matter
Claims 17-19 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.
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.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ELLEN C HAMMOND/Primary Examiner, Art Unit 3773
Prosecution Insights