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 .
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.
Claim Objections
Claims 28, 34, 37, and 39 objected to because of the following informalities:
In claim 28, line 1, “claim 23” should be “claim 26”.
In claim 34, line 3, “positioning femoral component” should be “positioning a femoral component”.
In claim 37, line 1, “claim 34” should be “claim 35”.
In claim 39, line 1, “claim 34” should be “claim 37”.
Appropriate correction is required.
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.
Claim(s) 23-24, 31-35, 37, and 39 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gotfried (US7455673).
Regarding claim 23, Gotfried discloses a method of repairing a bone, the method comprising the steps of: positioning an intramedullary structure (412,416; Fig. 8) including a first hole (426) at least partially within the bone (see Fig. 8); positioning an extramedullary structure (406, 450, 462) including a second hole (458) adjacent the bone; attaching an alignment arm (448) to the intramedullary structure (via 408; see Fig. 8); and guiding the insertion of a first fastener (e.g., 424 and/or bone screw) through the first and second holes with the alignment arm (Fig. 8, col 12 lines 1-27).
Regarding claim 24, Gotfried further discloses the method of claim 23, further comprising the step of positioning the alignment arm (448) to be aligned with the first (426) and second (458) holes (see Fig. 8).
Regarding claim 31, Gotfried further discloses the method of claim 23, wherein the positioning of the intramedullary structure (see Fig. 8, 412, 416) includes positioning a femoral nail (col 12, lines 63-67, intramedullary nail is located in a femur thus meaning that it is a femoral nail) at least partially within the bone (see Fig. 8, intramedullary nail (412) is within femur (402)).
Regarding claim 32, Gotfried further discloses the method of claim 23, wherein the positioning of the extramedullary structure (406, 450, 462) includes positioning a femoral component (see Fig. 8, extramedullary structure (406, 450, 462) is positioned outside a femur and stabilizes movement of the bone) adjacent the bone (see Fig. 8, col 11, lines 63-67 and col 12, lines 1-5).
Regarding claim 33, Gotfried further discloses the method of claim 23, wherein the guiding of the insertion of the first fastener (e.g., 424 and/or bone screw) through the first and second holes (426, 458) is at least partially through a portion of the alignment arm (see Fig. 8, pin 424 goes through alignment arm (448)).
Regarding claim 34, Gotfried discloses a surgical method comprising: positioning a femoral nail (412,416) least partially within a bone; positioning a femoral component (406, 450, 462) adjacent an exterior surface of the bone (Fig. 8); attaching an alignment arm (448) to the femoral nail; and securing the femoral nail and femoral component to the bone using the alignment arm (see Fig. 8).
Regarding claim 35, Gotfried further discloses the method of claim 34, wherein the securing step comprises positioning the alignment arm (448) to permit a first fastener to be received within a first opening (426) of the femoral nail (412, 416) and a second opening (458) of the femoral component (406, 450, 462).
Regarding claim 37, Gotfried further discloses the method of claim 35, wherein the securing step comprises positioning the alignment arm (448) to permit a second fastener (screw) to be received within a third opening (444) of the femoral nail (412, 416).
Regarding claim 39, Gotfried further discloses the method of claim 37, wherein the securing step comprises positioning the alignment arm (448) to permit a third fastener (pin or bone screw) to be received within a fourth opening (middle element of 458) of the femoral component (406, 450, 462).
Claim(s) 42-44 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Smith et al. (US20160374738).
Regarding claim 42, Smith discloses a surgical method comprising the steps of: positioning an intramedullary structure (intramedullary nail 610) at least partially within a bone (see Fig. 14A-B); positioning an extramedullary structure (fixation plate 102) on an exterior surface of the bone (see Fig. 14B); attaching an alignment structure (606) to the intramedullary structure (610; see Fig. 14A-B); and using the alignment structure to guide insertion of a first fastener (screw 1206) into a first hole (826c) of the intramedullary structure and a second hole (208) of the extramedullary structure.
Regarding claim 43, Smith further discloses the method of claim 42, wherein the attaching step includes threading the alignment structure (606) to the intramedullary structure (610) (see Fig. 8A-B and paragraph [0066] - [0067], triangulating screw guide 606 has a threaded portion 802 which threads through a thumb screw socket 806 and into a first coupler 812 that is on intramedullary nail 610 to attach the triangulating screw guide to the intramedullary nail).
Regarding claim 44, Smith further discloses the method of claim 42, further comprising the step of using the alignment structure (606) to guide insertion of a second fastener (screw 1204) into a third hole (826b) of the intramedullary structure.
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(s) 25-29, 36, 38, and 40 are rejected under 35 U.S.C. 103 as being unpatentable over Gotfried (US7455673) as applied to claims 23, 35, 37, and 39 above, and further in view of Davison et al. (US7056322).
Regarding claim 25, Gotfried discloses all limitations as recited in claim 23, but fails to disclose the step of aligning a first cannula with the first and second holes.
Davison also discloses a method of repairing a bone comprising the step of inserting a fastener (bone screw) through a first hole (100) of an intramedullary structure (94) and a second (42) hole of an extramedullary device (see Figs.8-9 and col 9, lines 61-65). Davison teaches the step of aligning a first cannula (sheath 122) with the first (100) and the second (42) holes (Fig. 9). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have included a first cannula in Gotfried and perform the step of aligning a first cannula with the first and second holes, as taught by Davison, in order to improve alignment of the fasteners with the holes of the intramedullary nail (see col 1, lines 54-56).
Regarding claim 26, Gotfried discloses all limitations as recited in claim 23, but fails to disclose the step of guiding the insertion of a second fastener through a third hole of the intramedullary structure with the alignment arm.
Davison also discloses a method of repairing a bone comprising the step of inserting a fastener (bone screw) through a first hole (100) of an intramedullary structure (94) and a second (42) hole of an extramedullary device (see Fig.9 and col 9, lines 61-65). Davison teaches the step of guiding the insertion of a second fastener (bone screw) through a third hole (104) of the intramedullary structure with the alignment arm (32; see Fig. 9 and col 10, lines 6-26). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have included a second fastener in Gotfried and perform the step of guiding the insertion of the second fastener through a third hole of the intramedullary structure with the alignment arm, as taught by Davison, in order to ensure that the bone fasteners are placed in the correct hole of the intramedullary nail (see col 1, lines 26-31).
Regarding claim 27, Gotfried in view of Davison teach all limitations recited in claim 26, but fails to teach the step of aligning a second cannula with the third hole.
Davison further teaches the step of aligning a second cannula (sheath 126) with a third hole (104) of the intramedullary structure (see Fig. 9). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have included a second cannula in Gotfried and perform the step of aligning a second cannula with the third hole, as taught by Davison, in order to improve alignment of the fasteners with the holes of the intramedullary nail (see col 1, lines 54-56).
Regarding claim 28, Gotfried in view of Davison teaches all the limitations of claim 26, but fails to teach the step of guiding the insertion of a third fastener through a fourth hole of the extramedullary structure.
Davison further teaches the step of guiding the insertion of a third fastener (bone screw) through a fourth hole (54) of the extramedullary structure (see Fig. 9, col 10, lines 6-26). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have included a third fastener in Gotfried and perform the step of guiding the insertion of the third fastener through a fourth hole of the extramedullary structure, as taught by Davison, in order to ensure that the bone fasteners are placed in the correct hole of the intramedullary nail (see col 1, lines 26-31).
Regarding claim 29, Gotfried in view of Davison teach all the limitation as recited in claim 28, but fail to teach the step of aligning a third cannula with the fourth hole.
Davison further teaches the step of aligning a third cannula (sheath 130) with the fourth hole (54) (see Fig. 9). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have included a third cannula in Gotfried and perform the step of aligning a third cannula with the fourth hole, as taught by Davison, in order to improve alignment of the fasteners with the holes of the intramedullary nail (see col 1, lines 54-56).
Regarding claim 36, Gotfried discloses all the limitations as recited in claim 35, but fails to disclose wherein the securing step comprises positioning a first cannula to permit a first fastener to be received within the first and second openings.
Davison also discloses a method of repairing a bone comprising the step of positioning an alignment arm (32) to permit a first fastener (bone screw) to be received within a first opening (100) of a femoral nail (94) and a second opening (42) of a femoral component (38) (see Figs.8-9 and col 9, lines 61-65). Davison teaches the securing step comprises positioning a first cannula (sheath 122) to permit the first fastener (bone screw) to be received within the first (100) and second (42) openings. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have included a first cannula in Gotfried and perform the step of positioning the first cannula to permit a first fastener to be received within the first and second openings, as taught by Davison, in order to improve alignment of the fasteners with the holes of the intramedullary nail (see col 1, lines 54-56).
Regarding claim 38, Gotfried discloses all the limitations as recited in claim 37, but fails to disclose wherein the securing step comprises positioning a second cannula to permit the second fastener to be received within the third opening.
Davison also discloses a method of repairing a bone comprising the step of positioning an alignment arm (32) to permit a second fastener (bone screw) to be received within a third opening (104) of the femoral nail (94) (see Fig. 9 and col 10, lines 6-26). Davison teaches the securing step comprises positioning a second cannula (126) to permit the second fastener (bone screw) to be received within the third opening (104) (see Fig. 9). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have included a second cannula in Gotfried and perform the step of positioning a second cannula to permit the second fastener to be received within the third opening, as taught by Davison, in order to improve alignment of the fasteners with the holes of the intramedullary nail (see col 1, lines 54-56).
Regarding claim 40, Gotfried discloses all the limitations as recited in claim 39, but fails to disclose wherein the securing step comprises positioning a third cannula to permit the third fastener to be received within the fourth opening.
Davison also discloses a method of repairing a bone comprising the securing step of positioning the alignment arm (32) to permit a third fastener (bone screw) to be received within a fourth opening (54) of the femoral component (48) (see Fig.9 and col 10, lines 6-26). Davison teaches the securing step comprises positioning a third cannula (130) to permit the third fastener (bone screw) to be received within the fourth opening (54) (see Fig. 9). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have included a third cannula in Gotfried and perform the step of positioning a third cannula to permit the third fastener to be received within the fourth opening, as taught by Davison, in order to improve alignment of the fasteners with the holes of the intramedullary nail (see col 1, lines 54-56).
Claim(s) 30 and 41 are rejected under 35 U.S.C. 103 as being unpatentable over Gotfried (US7455673) as applied to claims 23 and 34 above, and further in view of Neufeld (US4103683).
Regarding claim 30, Gotfried discloses all limitations as recited in claim 23, but fails to disclose wherein the attaching the alignment arm to the intramedullary structure includes threading the alignment arm to the intramedullary structure.
Neufeld also discloses an alignment arm (27) connected to an intramedullary structure (10). Neufeld teaches the step of threading the alignment arm to the intramedullary structure (bolt 30 of arm 27 is threaded in 31 of structure 10). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have included the threaded component of Neufeld in the alignment arm of Gotfried and perform the step of threading the alignment arm to the intramedullary structure, as taught by Neufeld, in order to securely attach the alignment arm to the intramedullary structure and to allow for ease of disassembly and resetting of the intramedullary structure during surgical operation (col 1, lines 29-35).
Regarding claim 41, Gotfried discloses all limitations as recited in claim 34, but fails to disclose wherein attaching the alignment arm to the femoral nail includes threading the alignment arm to the femoral nail.
Neufeld also discloses an alignment arm (27) connected to femoral nail (10). Neufeld teaches the step of threading the alignment arm to the femoral nail (bolt 30 of arm 27 is threaded in 31 of structure 10). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have included the threaded component of Neufeld in the alignment arm of Gotfried and perform the step of threading the alignment arm to the femoral nail, as taught by Neufeld, in order to securely attach the alignment arm to the femoral nail and to allow for ease of disassembly and resetting of the femoral nail during surgical operation (col 1, lines 29-35).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JUSTIN ZHI-DE YAO whose telephone number is (571)272-5449. The examiner can normally be reached Monday - Friday 8:00 am to 5:00 pm.
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, Melanie Tyson can be reached at 571-272-9062. 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.
/JUSTIN ZHI-DE YAO/Patent Examiner, Art Unit 3774
/MELANIE R TYSON/Supervisory Patent Examiner, Art Unit 3774