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 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(s) 1, 2, 4-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schifano (20200281729A1) in view of Petit (2004/0082953A1).
In regard to claim 1, Schifano teaches an extra-articular stabilization implant (fig 26a) comprising:
a body portion (433, 434) defining a longitudinal axis and having a proximal end (top) and a distal end (bottom);
a first thread 406 formed on the body portion (on 434), the first thread having a first major diameter and a first minor diameter (the claim does not require these diameters be different, see fig 26a),
the first thread 406 includes a sharp bottom end 435, wherein the sharp bottom end 435 and the thread 406 are configured to be embedded into fragments to be coupled (capable of being used in this manner due to the sharp distal ends);
a second thread (406 is on both arms, see 406 on 433) formed on the body portion (434, 433), the second thread 406 having a second major diameter and a second minor diameter (the claim does not require these diameters to be different, see fig 26a),
the second thread 406 includes a sharp bottom end (at 435), wherein the sharp bottom end 435 and the thread 406 are configured to be embedded into fragments to be coupled; (capable of being used in this manner due to the sharp distal ends);
and a head portion (432) disposed at the proximal end of the body portion, the head portion having a driver receiving portion 402 [0128: complimentary to a bit recess in the implant inserter].
However, Schifano remains silent to if the threading is helical or extends to the sharp bottom end of the implant where the sharp bottom end is located.
Petit teaches a similar bone implant for use in a spine which helical threading 10 along the entire body of the implant to the bottom end (see figs 5-6). [0065]
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the threading of Petite in place of the threading of Schifano on both the first and second bodies (434, 433) because the threading allows the implant to self cut into the bone [0065; 0061] and because thread along the entire implant length will allow for a stronger hold than only being partially threaded. When the threading of Petit is applied to the body 434 and 433 of Petit, the threads will extend to the sharp bottom end 435 of Schifano.
In regard to claim 2, Schifano meets the claim limitations as discussed in the rejection of claim 1, and further teaches the body portion (434, 433) is a tube defined by an inner surface of the first helical thread and the second helical thread. (see fig 25d, the two arms of the body portion 433 and 434 form a tube; since the helical thread 406 is on the arms, the thread also forms the tube)
In regard to claim 4, Schifano meets the claim limitations as discussed in the rejection of claim 2, and further teaches the driver receiving portion 402 includes a radial notch. (see notches around the circumference of 402 in figure 25c; [0133])
In regard to claim 5, Schifano meets the claim limitations as discussed in the rejection of claim 4, but does not teach the helical threads as claimed.
Petit further teaches the first major diameter and the second major diameter are equal. The threading of Petit is the same across the implant body (figure 5) and will be applied to both the first and second bodies 434, 433 in the same manner, therefore having the same major (maximum) diameters.
In regard to claim 6, Schifano meets the claim limitations as discussed in the rejection of claim 4, but does not teach the helical threads as claimed.
Petit further teaches the first minor diameter and the second minor diameter are equal. The threading of Petit is the same across the implant body (figure 5) and will be applied to both the first and second bodies 434, 433 in the same manner, therefore having the same minor (minimum) diameters.
In regard to claim 7, Schifano meets the claim limitations as discussed in the rejection of claim 6, and further teaches the extra-articular stabilization implant further comprises a gap between the first thread 406 on 434 and the second thread 406 on 433. (Each thread 406 is located on a separate arm, 434 and 433. Therefore there will be a gap between the first and second helical threads).
As discussed in the rejection of claim 1, the threads being helical are taught by Petit.
In regard to claim 8, Schifano teaches an extra-articular stabilization implant (figure 26a) comprising:
a body portion (434, 433) defining a longitudinal axis (vertical axis) and having a proximal end (top) and a distal end (bottom),
the body portion (434, 433) is a tube (see fig 25d, forms a tube) defined by an inner surface of the threads (inner surface of the threads 406 is interpreted as the side opposite to the threaded side; 434, 433 forms a tube)
a first thread 406 formed on the body portion 434, the first thread having a first major diameter (maximum) and a first minor diameter (minimum) (fig 26a);
a second thread 406 formed on the body portion 433, the second thread having a second major diameter (maximum) and a second minor diameter (minimum) (fig 26a);
and a head portion 432 disposed at the proximal end of the body portion (434, 433), the head portion 432 having a driver receiving portion 402 [0128: head having a structure that is complimentary to a bit recess on the implant inserter].
However, Schifano remains silent to if the threads are helical.
Petit teaches a similar bone implant for use in a spine which helical threading 10 along the entire body of the implant (see figs 5-6). [0065] When applied to Schifano the inner surface (interpreted as the opposite surface to the threads) will define a tube (see figures 5-6)
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the threading of Petite in place of the threading of Schifano on both the first and second bodies (434, 433) because the threading allows the implant to self cut into the bone [0065; 0061] and because threading the entire implant will provide a more secure hold in the bone.
Claim(s) 3, 9, 10-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schifano (20200281729A1) in view of in view of Petit (2004/0082953A1) and further in view of Hung (20110262883A1).
In regard to claim 3, Schifano meets the claim limitations as discussed in the rejection of claim 2, but does not teach the driver receiving portion is a pentagonal opening.
Hung teaches the driver receiving portion includes a pentagonal opening. [0002]
It would have been obvious to one of ordinary skill in the art of bone implants and surgical tools, at the time the invention was filed to use the pentagonal shape slot in place of the slot shape of Schifano through functional equivalents since it appears that either shape would work equally well depending on the type of driver tool used. Absent a teaching of criticality (new or unexpected results), this arrangement is deemed to have been known by those skilled in the art at the time the invention was filed. MPEP 2144.06II
In regard to claim 9, Schifano meets the claim limitations as discussed in the rejection of claim 8, but does note teach the driver receiving portion includes a pentagonal opening.
Hung teaches the driver receiving portion includes a pentagonal opening. [0002]
It would have been obvious to one of ordinary skill in the art of bone implants and surgical tools, at the time the invention was filed to use the pentagonal shape slot in place of the slot shape of Schifano through functional equivalents since it appears that either shape would work equally well depending on the type of driver tool used. Absent a teaching of criticality (new or unexpected results), this arrangement is deemed to have been known by those skilled in the art at the time the invention was filed. MPEP 2144.06II
In regard to claim 10, Schifano meets the claim limitations as discussed in the rejection of claim 9, and further teaches the driver receiving portion 402 includes a radial notch. (see fig 25c; 0128: notches)
In regard to claim 11, Schifano meets the claim limitations as discussed in the rejection of claim 10, but does not teach the threading as claimed.
Petit further teaches the first major diameter (maximum diameter) and the second major diameter (maximum diameter) are equal. The major diameter is interpreted as the largest diameter of the thread. The threading of Petit is the same across the implant body (figure 5) and will be applied to both the first and second bodies 434, 433 in the same manner, therefore having the same diameters.
In regard to claim 12, Schifano meets the claim limitations as discussed in the rejection of claim 10, but does not teach the threading as claimed.
Petit further teaches the first minor diameter and the second minor diameter are equal. The minor diameter is interpreted as the smallest diameter of the thread. The threading of Petit is the same across the implant body (figure 5) and will be applied to both the first and second bodies 434, 433 in the same manner, therefore having the same diameters.
In regard to claim 13, Schifano meets the claim limitations as discussed in the rejection of claim 12, and further teaches the extra-articular stabilization implant further comprises a gap between the first thread (406 on 434) and the second thread (406 on 433). Since each thread is on a different arm, the threads must necessarily contain a gap. However, Schifano does not teach the threads are helical as claimed. As discussed in the rejection of claim 8, Petit teaches the threads are helical and therefore when they are applied to teach arm of Schifano 434, 433, the threads will have a gap due to the arm structure.
In regard to claim 14, Schifano teaches an extra-articular stabilization implant (fig 26a) comprising:
a body portion (433, 434) defining a longitudinal axis (vertical axis) and having a proximal end (top) and a distal end (bottom);
a first thread 406 formed on the body portion 434, the first thread having a first major diameter (max) and a first minor diameter (min) (fig 26a);
a second thread formed 406 on the body portion 433, the second thread having a second major diameter (max) and a second minor diameter (min) (fig 26a);
and a head portion 432 disposed at the proximal end of the body portion (433, 434), the head portion 432 having a driver receiving portion 402.
However, Schifano does not teach the thread is helical and does not teach the driver receiving portion includes a pentagonal opening.
Hung teaches the driver receiving portion includes a pentagonal opening. [0002]
It would have been obvious to one of ordinary skill in the art of bone implants and surgical tools, at the time the invention was filed to use the pentagonal shape slot in place of the slot shape of Schifano through functional equivalents since it appears that either shape would work equally well depending on the type of driver tool used. Absent a teaching of criticality (new or unexpected results), this arrangement is deemed to have been known by those skilled in the art at the time the invention was filed. MPEP 2144.06II
Petit teaches a similar bone implant for use in a spine which helical threading 10 along the entire body of the implant (see figs 5-6). [0065]
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the threading of Petite in place of the threading of Schifano because the threading allows the implant to self cut into the bone [0065; 0061] and because thread along the entire implant length will allow for a stronger hold than only being partially threaded.
In regard to claim 15, Schifano meets the claim limitations as discussed in the rejection of claim 14, and further teaches the body portion 343, 433 is a tube (see fig 25a).
However, Schifano does not teach the first and second threads are helical or that the threads define a tube.
Petit further teaches a tube defined by an inner surface of the first helical thread and the second helical thread. (see figures 5-6; the inner surface of the threads is interpreted as the surface opposite to the thread points or internal to the tube). The examiner suggests further describing the location of the threads in the claims.
In regard to claim 16, Schifano meets the claim limitations as discussed in the rejection of claim 15, and further teaches the driver receiving portion 432 includes a radial notch (see notch on 402 in fig 25c; 0128: notches).
In regard to claim 17, Schifano meets the claim limitations as discussed in the rejection of claim 16, but does not teach the threads as claimed.
Petite further teaches the first major diameter and the second major diameter are equal. The threading of Petit is the same across the implant body (figure 5) and will be applied to both the first and second bodies 434, 433 in the same manner, therefore having the same diameters. Major diameter is interpreted as the maximum diameter of the threads.
In regard to claim 18, Schifano meets the claim limitations as discussed in the rejection of claim 16, but does not teach the threads as claimed.
Petit further teaches the first minor diameter and the second minor diameter are equal. The threading of Petit is the same across the implant body (figure 5) and will be applied to both the first and second bodies 434, 433 in the same manner, therefore having the same diameters. The minor diameter is interpreted as the minimum diameter)
In regard to claim 19, Schifano meets the claim limitations as discussed in the rejection of claim 18, and further teaches the extra-articular stabilization implant further comprises a gap between the first thread (406 on 434) and the second thread (406 on 433). Since each thread is on a different arm, the threads must necessarily contain a gap.
However, Schifano does not teach the threads are helical.
As discussed in the rejection of claim 14, Petit teaches the threads are helical.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTIE BAHENA whose telephone number is (571)270-3206. The examiner can normally be reached M-F 9-3.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Barrett can be reached at 571-272-4746. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/CHRISTIE BAHENA/Primary Examiner, Art Unit 3774