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 .
Response to Arguments
Applicant’s arguments with respect to claim(s) 30 below have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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.
Claims 30, 32-33, 35-38, 40, 41 are rejected under 35 U.S.C. 103 as being unpatentable over Mehl US 2016/0287301 in view of Marino US, Greenhalgh JP-2014014717 (reference is made to the English Translation attached), and Sweeny US 2006/0264954.
Regarding Claim 30, Mehl discloses an interintervertebral device (#40, Fig 4, paragraph 81 where #40 is similar to #10 shown in Fig 1-2 but #40 has fill holes #46-#48, Fig 23, paragraph 3, 81, where it is also capable of being placed across a bone joint such as between two bones such as between two vertebrae), comprising:
(i) an interintervertebral stabilizing screw (Fig 4), comprising:
a main body (#42, synonymous with #12 in Fig 1) with an axial hole (Fig 4, fill holes #46-48 lead into an axial hole, paragraph 82) and a distal thread (#44) for securing to the bone, located at a distal end of the main body (paragraph 82, Fig 4);
a hollow proximal secondary body (#14) configured to slide along the length of the main body (threadably slides along the main body via threads #18, paragraph 82),
wherein the hollow proximal secondary body (#12) further includes an external thread (#19, paragraph 78, Fig 4) for securing to the bone (paragraph 78),
said main body comprises a first fill hole and a second fill hole (#46, #47, paragraph 82), located between the distal thread (#44) and a distal end of the hollow proximal secondary body (bottom end of #14, Fig 4), for connecting an interintervertebral space to said through hole axial hole (Fig 23, capable of being placed between adjacent vertebra such that the fill hole is capable of being placed in the interintervertebral space),
wherein the main body is a single piece body (as seen in Fig 1, 4) separated by a proximal area (covered by the secondary body #14 in Fig 4 but shown as #27 in Fig 1) and a distal area (#49, Fig 4) in which the distal thread (#44) is disposed (Fig 4, 1).
Mehl discloses that the location of where the fill holes (#46-48) on the main body constitutes as a middle section for the main body, located between the proximal and distal areas (Fig 1, 4, see Fig below) but does not disclose:
the axial hole is an axial through hole, and a travel stop for the hollow proximal secondary body, located on an outer surface of the main body,
(ii) a composition for bone remodeling, comprising: a polymerizable bone cement; a calcium phosphate provider; and an oxygen providing compound,
wherein said travel stop is a step formed by a variation in an external diameter of the main body and configured to limit travel of the hollow proximal secondary body,
the first fill hole and second fill hole are located between the distal thread and said travel stop,
wherein a maximum external diameter of said travel stop equals the external diameter of the main body where the first fill hole and second fille hole are located, the main body is a single piece body separated by the travel stop into a proximal area and a distal area in which the distal thread is disposed,
a maximum external diameter of the thread of the hollow proximal secondary body is greater than a maximum diameter of the distal thread,
wherein a direction in which the first fil hole penetrates the main body is configured to be substantially 90 degrees relative to a direction in which the second fill hole penetrates the main body.
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Marino also discloses a bone screw (Fig 6a), where the screw (#600, Fig 6a, which is similar to the embodiment of Fig 1-2) has a hollow proximal secondary body (proximal portion of #600, see also Fig 1-2) and a main body (remainder of the screw #600) having fill hole (#635) where the entire screw including the main body includes an axial through hole (#640, paragraph 53) so that screw including the axial through hole and fill hole can be filled with a composition for bone remodeling (paragraph 37, 49, 61), a maximum external diameter of a thread (#615) of the hollow proximal secondary body is greater than a maximum diameter (#625) of the distal thread (Fig 6a) and also has a different pitches, where the distal thread is first threaded into the bone and this configuration aids in compressing bones together (Fig 6a, paragraph 48, 53).
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 Mehl and have the axial hole be a axial through hole, a maximum external diameter of the thread of the hollow proximal secondary body is greater than a maximum diameter of the distal thread, and for the device to be filled with a composition for bone remodeling in view of Marino above because it is known that screw with fill holes are used for bone growth/fusion, where the axial through hole allows the device to be filled with a composition for bone remodeling and the different diameters aid in compressing bones together. Examiner notes that it is known in the art to provide compressive force to help stimulate bone growth/fusion.
Marino also discloses another embodiment (#100, Fig 1a-1b) having a main body (#130) and a plurality of fill holes (four holes #135), where the fill holes are substantially 90 degrees off set from each other (as seen in Fig 1a and see also Fig 3 where a first pair of fill holes, left-most and right-most holes #135 are diametrically oppose to each other with a middle fill hole #135 therebetween), such that wherein a direction in which a first fill hole (left-most or right-most fill hole #135 in Fig 3) penetrates the main body is configured to be substantially 90 degrees relative to a direction in which a second fill hole (middle fill hole #135, Fig 3) penetrates the main body, where there is provides known locations for filles for the purpose of bone growth (Fig 1a, 3, paragraph 49).
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 Mehl as modified to have four fill holes that are substantially 90 degrees off set from each other such that the a first fill hole penetrates the main body is configured to be substantially 90 degrees relative to a direction in which a second fill hole penetrates the main body in view of another embodiment of Marino above because this provides a known number and location for fill holes on a body to provide predictable results of promoting bone growth through the fill holes.
Greenhalgh teaches a composition for bone remodeling for bone growth/fusion (page 15, paragraph 3-4), comprising: a polymerizable bone cement (page 15, paragraph 4, PMMA); a calcium phosphate provider (page 15, paragraph 4); and an oxygen providing compound (page 15, paragraph 4, demineralized water bone matrix). Regarding Claim 41, Greenhalgh further teaches the composition further comprises an osteogenic factor (page 15, paragraph 3 “osteogenic and osteoinductive growth factors”).
It would have also been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to have the composition of Mehl as modified to include a bone cement, calcium phosphate provider, and an oxyfen providing compound in view of Greenhalgh above because this provides a known composition to promote bone growth/fusion.
Sweeny discloses a screw (Fig 8-9), comprising: a main body (#120) a distal thread (#170) for securing to the bone, located at a distal end of the main body (paragraph 37, Figs 8-9), a hollow proximal secondary body (#110) that can slide along the length of a proximal portion (#150) the main body (Fig 8-9, paragraph 36); and
a travel stop (#240) for the proximal secondary body, located on an outer surface of the main body (Fig 8-9, paragraph 53), said travel stop is a step (#240) formed by a variation in an external diameter of the main body (Fig 8-9) and configured to limit travel of the hollow proximal secondary body (paragraph 53), said main body comprises middle section (#160), located between the distal thread and said travel stop (Fig 8-9), a maximum external diameter of said travel stop (#240) equals the external diameter of the main body where the middle section (#160) is located (as seen in Figs 8-9), the main body is a single piece body (Fig 8-9) separated by the travel stop (#240) into a proximal area (#150) and a distal area (#170) in which the distal thread is disposed (Fig 8-9), where the proximal portion (#150) of the main body is smaller in diameter than the middle section (#160) to form the travel stop (#240, Fig 8-9) where the travel stop limits the slideable position of the hollow proximal secondary body (paragraph 53).
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 Mehl to have the proximal area of Mehl have a smaller diameter than the middle section (where the fill holes are located) so as to form a travel stop in view of Sweeney above because the travel stop limits the slideable position of the hollow proximal secondary body. Examiner notes that looking at Fig 4 of Mehl, one of ordinary skill in the art can recognize that one would not want the hollow proximal secondary body to move closer to the distal area since that would block the fill holes.
Regarding Claim 32, Mehl as modified discloses an external diameter of the thread of the hollow proximal secondary body is greater than a diameter of the distal thread (as discussed with the modification in view of Marino where the max external diameter of the threads of the secondary body is greater than that of the distal thread).
Regarding Claims 33, Mehl as modified discloses wherein said travel stop consists of the step (as discussed above with the modification in view of Sweeney and as seen in Fig 8-9 in Sweeney) which impedes the travel of the hollow proximal secondary body up to said at least one fill hole (as discussed above in claim 30, the travel stop would be located above the fill holes so that the secondary body will not cover the fill holes).
Regarding Claims 35, Mehl as modified discloses said at least one fill hole comprises at least two fill holes (#46, #47, #48, paragraph 82 in Mehl).
Regarding Claims 36, Mehl as modified discloses said at least one fill hole has a radial course (Fig 4, paragraph 82, in Mehl the fill holes #46-48 at least partially radially surrounds the main body about its circumference).
Regarding Claims 37, Mehl as modified discloses said at least one fill hole comprises at least two fill holes and has a diametric course, with two outlets that connect opposite points of the wall of the main body (Fig 4, paragraph 82 in Mehl, where there can be four holes that are “evenly spaced” such that two of the holes are diametrically opposed to each other so that you can see completely through the screw).
Regarding Claim 38, Mehl as modified discloses the claimed invention as discussed above (paragraph 81 in Mehl where the embodiment of Fig 4 is similar to Fig 1 but has the fill openings) where both the main body and the hollow proximal secondary body have at the proximal end (#29 of the main body, paragraph 77 in Mehl and #23-#24 of the secondary body, paragraph 78 in Mehl) thereof devices for receiving a percutaneous tool (paragraph 77, 78 in Mehl). Alternatively, the secondary body of Mehl is hollow such that there is an opening at the proximal end (Fig 7 in Mehl), where a tool can be received through the opening and into socket #29 at the proximal end of the main body, paragraph 77 in Mehl).
Regarding Claim 40, Mehl as modified discloses the main body and the hollow proximal secondary body are threaded together (paragraph 78 in Mehl, via threads #26 and #18), in such a way that said sliding along the length of the main body comprises a relative rotation therebetween (paragraph 78 in Mehl).
Claim 31 is rejected under 35 U.S.C. 103 as being unpatentable over Mehl US 2016/0287301 in view of Marino US, Greenhalgh JP-2014014717 (reference is made to the English Translation attached), and Sweeny US 2006/0264954, as applied to claim 30 above, and in further view of Russell US 2011/0060373.
Mehl as modified discloses the claimed invention as discussed above but does not disclose comprising at least two of said intervertebral stabilizing screws.
Russell teaches a kit with one or more screws (#1)(paragraph 22), where the kit contains a composition (paragraph 22).
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 device of Mehl as modified to include at least another intervertebral stabilizing screw in a kit, which would also include the composition in view of Russell above because a kit provides the device ready for use, where one of ordinary skill in the art can recognize the other intervertebral screw can be used as a spare.
Claim 39 is rejected under 35 U.S.C. 103 as being unpatentable over Mehl US 2016/0287301 in view of Marino US, Greenhalgh JP-2014014717 (reference is made to the English Translation attached), and Sweeny US 2006/0264954, as applied to claim 30 above, and in further view of Braun US 2003/0088251.
Mehl discloses the claimed invention as discussed above where the axial through hole may be filled with material after implantation (paragraph 49 in Marino) but does not disclose a proximal cover to close off access to the axial hole once the intervertebral screw is installed.
Braun discloses a screw main body (#30) with an axial through hole (#44, Fig 3) that is filled with material (paragraph 32), a proximal cover (#60) to close off access to the axial hole once the screw is installed (Fig 8), the proximal cover (#60) compresses the material in the axial through hole of the screw (paragraph 32, 42).
It would have been obvious to one having ordinary skill in the art at a time before the invention was made to modify Mehl as modified to include a proximal cover in view of Braun because it helps compresses the material within the through hole of the screw.
Claim 42 is rejected under 35 U.S.C. 103 as being unpatentable over Mehl US 2016/0287301 in view of Marino US, Greenhalgh JP-2014014717 (reference is made to the English Translation attached), and Sweeny US 2006/0264954, as applied to claim 30 above, and in further view of D’Agostino US 2014/0178328 (cited by applicant).
Mehl as modified discloses the claimed invention as discussed above but does not disclose the composition further comprises a contrast agent.
D’Agostino discloses a composition for tissue growth (paragraph 51), the composition further comprises a contrast agent (paragraph 52) to enhance visualization of the composition during implantation (paragraph 52).
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 composition of Mehl as modified to include a contrast agent in view of D’Agostino above because it enhances visualization of the composition during implantation.
Claim 48 is rejected under 35 U.S.C. 103 as being unpatentable over Mehl US 2016/0287301 in view of Marino US, Greenhalgh JP-2014014717 (reference is made to the English Translation attached), and Sweeny US 2006/0264954, as applied to claim 30 above, and in further view of Lichty US 4,456,005.
Mehl as modified discloses the claimed invention as discussed above where the device is Mehl is used for bone compression (paragraph 81 in Mehl ) but does not disclose a location of the travel stop is determined such that a proximal end of the main body projects from the proximal secondary body when the proximal secondary body contacts the travel stop.
Lichty also discloses a similar device comprising compression screw (Fig 1) having a main body (#10, Fig 1-2), a proximal secondary body (#12) threaded onto a proximal portion (#22) of the main body (Fig 3-4), the main body having sufficient length to project above the proximal secondary body during use so that a nut (second nut #14) can be threaded onto the main body after the bone has been compressed to help secure the device in place (Col 3 lines 15-20).
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 Mehl as modified to extend the length of the proximal threaded portion of the main body proximal secondary body (see annotated Fig of Mehl above in claims 1, 8, 10 above) such that a nut can be installed after the bone has been compressed, in view of Lichty above because the nut helps secure the device in place. It is noted that with the modification, the main body has sufficient length such that a location of the travel stop is determined (adjacent the least one fill hole, see rejection above in claim 1), such that a proximal end of the main body projects (projects such that a nut can be installed in view of Lichty above) from the proximal secondary body when the proximal secondary body contacts the travel stop.
It is noted, the modification is for including only one nut in view of Lichty for the purpose of securing/locking the device in place, where the one nut would aid in preventing the hollow proximal secondary body from separating/backing (loosening) out from the main body.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Eduardo Robert can be reached 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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/JAN CHRISTOPHER L MERENE/Primary Examiner, Art Unit 3773