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 .
Priority
The current claims have support going back to US Provisional 63/249,797 filed September 29, 2021 and have an effective filing date of September 29, 2021.
Information Disclosure Statement
Applicant should note that the large number of references in the attached IDS have been considered by the examiner in the same manner as other documents in Office search files are considered by the examiner while conducting a search of the prior art in a proper field of search. See MPEP 609.05(b). Applicant is requested to point out any particular references in the IDS which they believe may be of particular relevance to the instant claimed invention in response to this office action.
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, 5-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jimenez US 2015/0272743.
Regarding Claim 1, Jimenez discloses an expandable intervertebral cage device (Fig 1a-1b) adapted to be implanted into an intervertebral disc space in a patient's body (paragraph 2), comprising:
a first base plate (see Fig below) having a first outer bearing surface configured to interface with a first vertebra of the intervertebral disc space (see Fig below, paragraph 45);
a second base plate (see Fig below) having a second outer bearing surface configured to interface with a second vertebra of the intervertebral disc space (see Fig below, paragraph 45);
a proximal block (see Fig below) comprising internal threading (#48, see also Fig 7, paragraph 51);
a distal block (see Fig below) comprising an internal passage (see Fig below), the distal block further including a block protrusion extending outwardly from each of a first side of the distal block and the second side of the distal block (see Fig below, where only one block protrusion is shown, there is another block protrusion on the other side, paragraph 47, where each block protrusion couples with arms #16, #18);
two arm assemblies, wherein one arm assembly is on each of the first side of the device and the second side of the device (see Fig below, paragraph 47, where there are arms #16, #18 at each of the first and second sides) and
wherein each arm assembly comprises: a first arm pivotally coupled to the first base plate and the block protrusion on the corresponding side of the device the distal block (see Fig below, where only one block protrusion is shown, there is another block protrusion on the other side, paragraph 47, where each block protrusion couples with upper arms #16 that engage with the first base plate and see also paragraph 53, Fig 1a, 2a where the arms pivot/rotate); and
a second arm pivotally coupled to the second base plate and the block protrusion on the corresponding side of the device the distal block (see Fig below, where only one block protrusion is shown, there is another block protrusion on the other side, paragraph 47, where each block protrusion couples with lower arms #18 that engage with the second base plate and see also paragraph 53, Fig 1a, 2a where the arms pivot/rotate); and
a screw (#19, see Fig below) extending between internal threading of the proximal block and the internal passage of the distal block (see Fig below, paragraph 49), such that rotation of the screw relative to the proximal block causes a change in distance between the distal block and the proximal block, and a corresponding change in the spacing and lordosis of the device (paragraph 49, 53 where rotation of the screw changes the height of the device, as seen in Fig 1a-2d).
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Regarding Claim 5, Jimenez discloses only two arm assemblies (as discussed above in claim 1, see Figs above in claim 1 where there are only two arm assemblies, one on each of the first and second lateral sides).
Regarding Claim 6, Jimenez discloses the first base plate and the second base plate each have an opening defined therein configured to allow bone growth into an open space defined by the device (see Fig below, paragraph 45 where both plates have a similar configuration where each would have an opening).
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Regarding Claim 7, Jimenez discloses the screw is threadedly coupled to the internal threading of the proximal block (as seen in Fig 1d, 2d, paragraph 51), and the distal block includes a non-threaded rotational coupling to which the screw is non-threadedly rotationally coupled (see Fig below, paragraph 49 where the screw has a non-threaded portion coupled to passage #42).
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Regarding Claim 8, Jimenez discloses the screw includes a first portion (threaded portion as seen in Fig 2d) having a first diameter (Fig 2d) and a second portion (non-threaded portion in the internal passage as seen in Fig 2d) having a second diameter (Fig 2d).
Regarding Claim 9, Jimenez discloses rotation of the screw relative to the proximal block further causes the arm assemblies to expand an angle of the first base plate and the second base plate relative to each other (paragraph 49, 53 where rotation of the screw changes the height of the device and the angle of the base plates relative to each other, as seen in Fig 1a-2d).
Regarding Claim 10, Jimenez discloses wherein the change in distance between the distal block and the proximal block causes a distance between a proximal end of the first base plate and a proximal end of the second base plate to vary (paragraph 49, 53, Fig 1a, 2d where the distance between the distal and proximal blocks varies due to rotation of screw #19).
Claims 11-14, 19-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kuyler US 2017/0112630.
Regarding Claim 11, Kuyler discloses an expandable intervertebral cage device (Fig 30-33) adapted to be implanted into an intervertebral disc space in a patient's body (paragraph 1), comprising:
a first base plate (see Fig below) having a first outer bearing surface configured to interface with a first vertebra of the intervertebral disc space (see Fig below, paragraph 109);
a second base plate (see Fig below) having a second outer bearing surface configured to interface with a second vertebra of the intervertebral disc space (see Fig below, paragraph 110);
a proximal block (see Fig below) comprising internal threading (paragraph 116 where screw #721 is threaded onto the internal threading);
a distal block (see Fig below) comprising an internal passage (paragraph 119 where the screw #721 is within the internal passage),
two arm assemblies, wherein one arm assembly is on each of the first side of the device and the second side of the device (see Fig below, where there are arm assemblies on each lateral side) and
wherein each arm assembly comprises:
a first arm (see Fig below) pivotally coupled to the first base plate and the distal block (paragraph 118-119, Fig 31-32, where the arms pivot/rotate); and
a second arm (see Fig below) pivotally coupled to the second base plate and the distal block (paragraph 118-119, Fig 31-32 where the arms pivot/rotate),
wherein the second arm (see Fig below) comprises a body portion (see Fig below) and an arm protrusion (see Fig below) raised from the body portion (see Fig below); and
a screw (see Fig below) extending between the internal threading of the proximal block and the internal passage of the distal block (see Fig below), such that rotation of the screw relative to the proximal block causes a change in distance between the distal block and the proximal block (change in distance seen in Fig 31-32, paragraph 119) and the arm assemblies to expand from a collapsed configuration (as seen in Fig 31, paragraph 118-119) to an expanded configuration (as seen in Fig 32, paragraph 118-119), wherein in the collapsed confirmation each first arm nests with the corresponding second arm with the first arm overlapping the body portion and abutting the arm protrusion of the corresponding second arm (as seen in Fig 31 and see Fig 33 where the first arm nests with the second arm).
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Regarding Claim 12, Kuyler discloses only two arm assemblies (as seen in Fig 30-33 where there are only two arm assemblies).
Regarding Claim 13, Kuyler discloses both the first arm and the second arm of each arm assembly are mechanically coupled to a common point (Fig 32, where both arms are coupled on each side are coupled to a common point on pin #662, see Fig below, where the other common point is opposite the identified common point below) on the respective side of the distal block.
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Regarding Claim 14, Kuyler discloses the common point is an arm protrusion (#662 and #662a) extending outwardly from each of a first side and a second side of the distal block (pin or arm protrusions #662a, #662 extend out from their respective sides).
Regarding Claim 19, Kuyler discloses wherein rotation of the screw relative to the proximal block further causes the arm assemblies to expand an angle of the first base plate and the second base plate relative to each other (as seen in Fig 30-31, paragraph 118-119 where the arms are rotated when the screw is rotated).
Regarding Claim 20, Kuyler discloses the change in distance between the distal block and the proximal block causes a distance between a proximal end of the first base plate and a proximal end of the second base plate to vary, where the distal block moves with the screw when the screw is rotated (as seen in Fig 30-31, paragraph 118-119 where the distance between the blocks change when rotated when the screw is rotated).
Claims 1-2 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kuyler US 2017/0112630.
Regarding Claim 1, Kuyler discloses an expandable intervertebral cage device (Fig 30-33) adapted to be implanted into an intervertebral disc space in a patient's body (paragraph 1), comprising:
a first base plate (see Fig below) having a first outer bearing surface configured to interface with a first vertebra of the intervertebral disc space (see Fig below, paragraph 109);
a second base plate (see Fig below) having a second outer bearing surface configured to interface with a second vertebra of the intervertebral disc space (see Fig below, paragraph 110);
a proximal block (#644, see Fig below) comprising internal threading (paragraph 116 where screw #721 is threaded onto the internal threading);
a distal block (#720, see Fig below) comprising an internal passage (paragraph 119 where the screw #721 is within the internal passage), the distal block further including a block protrusion (#662, #662a, as seen in Fig 33) extending outwardly from each of a first side of the distal block and the second side of the distal block (see Fig below, where only one block protrusion is shown, there is another block protrusion on the other side, paragraph 47, where each block protrusion couples with arms #16, #18);
two arm assemblies, wherein one arm assembly is on each of the first side of the device and the second side of the device (see Fig below, where there are arm assemblies on each lateral side) and
wherein each arm assembly comprises:
a first arm (see Fig below) pivotally coupled to the first base plate and the block protrusion on the corresponding side of the device the distal block (paragraph 118-119, Fig 31-32, where the arms pivot/rotate); and
a second arm (see Fig below) pivotally coupled to the second base plate and the block protrusion on the corresponding side of the device the distal block (paragraph 118-119, Fig 31-32 where the arms pivot/rotate); and
a screw (#721, see Fig below) extending between internal threading of the proximal block and the internal passage of the distal block (Fig 30-32, paragraph 116-117), such that rotation of the screw relative to the proximal block causes a change in distance between the distal block and the proximal block, and a corresponding change in the spacing and lordosis of the device (paragraph 119, as seen in Fig 31-32).
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Regarding Claim 2, Kuyler discloses each first arm includes a block connection aperture and each second arm includes a block connection aperture (see Fig 33, paragraph 111-112 where each arm has an aperture that receives a respective block protrusion #662, #662a), and wherein the block connection aperture of each first arm and the block connection aperture of the corresponding second arm are aligned and inserted onto the block protrusion on the corresponding side of the device (as seen in Fig 33, paragraph 111-112).
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 15 is rejected under 35 U.S.C. 103 as being unpatentable over Kuyler US 2017/0112630 in view of Jimenez US 2015/0272743.
Kuyler discloses the claimed invention as discussed above where the arm protrusion (#662, #662a) couples to the first arm and the second arm on each side of the device but does not disclose a ring coupling the arm protrusion to the first arm and the second arm on each side of the device.
Jimenez discloses an arm protrusion (#26, Fig 1a) with a groove (#52, Fig 8) that is coupled to an arm (#16, Fig 1a), a ring (#20, Fig 1a, Fig 5) coupling the arm protrusion to the arm via the groove to support the interconnection and prevents lateral movement between the arm protrusion and arm (paragraph 48).
It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify the arm protrusions of Kuyler to each include a groove and a ring in view of Jimenez because the ring snaps onto the groove and supports support the interconnection and prevents lateral movement between the respective arm protrusion and first and second arms.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Kuyler US 2017/0112630 in view of Butler US 2017/0224505
Kuyler discloses the claimed invention as discussed above where the proximal block has an opening (Fig 31, where the screw #721 is inserted through an opening in the proximal block, where screw #721 is shown partially extending out from the opening) defined sized and configured to receive the screw (Fig 31), where the device is for bone growth (paragraph 53, 55) but does not disclose the opening is sized and configured to enable insertion of a bone growth material into an open area within the device.
Butler discloses a fusion cage device (Fig 33) with upper and lower base plates (#218, #220), a screw (#216) having ports (#238), a proximal block (#214), the screw (#216) received through an opening in the proximal block (Figs 31-32, 34), the opening sized and configured to receive the screw and enable insertion of a bone growth material into an open area (as seen in Fig 31-32, 34 where ports #238 are in communication with an open area) within the device (Fig 31-32, 33, paragraph 57, where growth material is inserted through the opening and through the screw and out the ports) to provide a fluid path with the open space of the device for the insertion of bone growth materials.
It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify the screw of Kuyler to include ports in view of Butler such that the opening of the proximal block provide a fluid path with the open space of the device for the insertion of bone growth materials. The examiner notes that with the modification, the opening would be sized and configured to enable insertion of a bone growth material into an open area within the device.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Kuyler US 2017/0112630.
Regarding Claim 17, Kuyler discloses the claimed invention as discussed above where the device is used for bone growth/fusion (paragraph 53, 55) and has an open space therein (as seen in Fig 30-33 where the screw #721 and distal block #720 are located in the open space) but does not explicitly disclose the first base plate and the second base plate each have an opening defined therein configured to allow bone growth into an open space defined by the device.
Kuyler discloses another embodiment (Fig 7-16) where the first base plate and the second base plate each have an opening defined therein configured to allow bone growth into an open space defined by the device (see Fig below) to allow bone to grow through the implant (paragraph 53, 55).
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It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify Kuyler to have the first and second base plates to each include an opening in view of another embodiment of Kuyler above in order for bone to grow through the implant.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Kuyler US 2017/0112630 in view of Jimenez US 2015/0272743.
Kuyler discloses the claimed invention as discussed above wherein the screw is threadedly coupled to the internal threading of the proximal block (paragraph 116 where screw #721 is threaded onto the internal threading) but does not disclose the distal block includes a non-threaded rotational coupling to which the screw is non-threadedly rotationally coupled.
Jimenez discloses a similar device (see rejection for claim 1 in view of Jimenez above) with a screw (#19) is threadedly coupled to the internal threading (#48) of the proximal block (#24, paragraph 51) and the distal block (#22) includes a non-threaded rotational coupling to which the screw is non-threadedly rotationally coupled (see Fig below, paragraph 49) such that the distal block moves along with the screw to change the distance between the first and second base plates (paragraph 49 )
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Kuyler US 2017/0112630 in view of Jimenez US 2015/0272743.
Kuyler discloses the claimed invention as discussed above where the arm protrusion (#662, #662a) couples to the first arm and the second arm on each side of the device but does not disclose a ring configured to be inserted over the block protrusion on each side of the device on an outside of the first arm and the second arm.
Jimenez discloses a similar device (see rejection for claim 1 in view of Jimenez) with a protrusion (#26, Fig 2a, paragraph 48) with a groove (#52, Fig 8), an arm (#16) coupled to the protrusion (Fig 2a, paragraph 48), a ring (#20, Fig 2a, Fig 5) coupling the protrusion to the arm via the groove to support the interconnection and prevents lateral movement between the protrusion and arm (paragraph 48).
It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify the arm protrusions of Kuyler to each include a groove and a ring in view of Jimenez because the ring snaps onto the groove and supports support the interconnection and prevents lateral movement between the respective arm protrusion and first and second arms. The examiner notes that with the modification, the ring would be in over the block protrusion on each side of the device on an outside or exterior of the first arm and the second arm as the ring would not be placed in between the arms.
Allowable Subject Matter
Claim 4 is 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: Kuyler in view of Jimenez is the closest pieces of prior art as this combination discloses the claimed invention as discussed above in claim 3. However, the ring (#20 in Jimenez) couples to a groove (#52, Fig 8 in Jimenez) on a protrusion (#26) and does not disclose the groove is in the first arm. As such, “the ring fits into a groove in the first arm..” in claim 4 is not taught by the prior art. It is noted that rings to prevent backing out of shafts is known in other orthopedic areas, for example see Bailey US 2002/0151899 which has a plate (#36) with a groove (#80) for a ring (#16)(Fig 1, 4) to prevent backing out of screw (#25), where the ring (#16) of Bailey (and devices similar to Bailey, such as Speirs US 2006/0009770) does not seem applicable to modify the spinal implant of Kuyler having pivotal arms. See PTO-892 for art of cited interest, in particular other spinal implants with pivoting arms.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAN CHRISTOPHER L MERENE whose telephone number is (571)270-5032. The examiner can normally be reached Mon-Fri 8:30 am - 6pm EST.
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/JAN CHRISTOPHER L MERENE/ Primary Examiner, Art Unit 3773