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 all pending claims 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. With respect to Applicant’s amendment to further define the that measurement system includes a permanent prosthetic knee joint coupled to the leg. Roche et al. expressly discloses that their measurement system can be used in both a trial prosthesis (341/342, figures 3A, 3C-3D, ¶44) or in a permanent prosthetic knee joint (500, figure 5, ¶63-64) as they are known equivalents for performing the same function of dynamically tracking and measuring leg alignment through dynamic movement.
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.
Claims 21-22, 24, 26-29, 36 and 38-40 are rejected under 35 U.S.C. 103 as being unpatentable over Nguyen et al. (US 2015/0342516) in view of Roche et al. (US 2012/0232834) in view of Stein (US 2014/0288464).
Regarding claim 21, Nguyen et al. disclose a method of measuring leg alignment, comprising moving a leg through at least one first movement (¶45); generating measurement data corresponding to the at least one first movement via a measurement system (10 + 100, figure 3A) coupled to the leg (¶34-35, ¶41-42, ¶45); using the measurement data corresponding to the at least one first movement, determining a first angle (HKA, figure 1A) included in a triangle formed by a first line extending from a hip joint of the leg to a knee joint of the leg (FM, figure 1A), a second line extending from the knee joint to an ankle joint of the leg (TM, figure 1A), and a third line extending from the hip joint to the ankle joint (LBA, figure 1A); using the first angle, determining an alignment measurement of the leg (¶28-30, ¶32, ¶37, ¶42).
Nguyen et al. fails to expressly teach or disclose displaying the alignment measurement of the leg on a display.
Roche et al. teach the use of a display (108, figure 3D) to display alignment measurement of the leg on the display (figure 3D, ¶19, ¶44).
Accordingly, it would have been obvious to one of ordinary skill in the art at the time of filing to have provided the method of Nguyen et al. to include a display for displaying the alignment measurement of the leg as taught by Roche et al. as it provides additional visual confirmation of the knee alignment. Additionally, Stein fails to expressly teach or disclose the measurement system includes a tibial stem inserted into a tibia. Stein teaches the use of a tibial stem (3124, figures 31-34) inserted into a tibia (¶222). The use of a tibial stem allows for alignment and support of the tibial tray (¶222).
Accordingly, it would have been obvious to one of ordinary skill in the art at the time of filing to have constructed the measurement system include a tibial stem inserted into a tibia of the leg as taught by Stein as the stem allows for alignment and support of the tibial tray. Regarding claim 22, Nguyen et al. disclose the measurement system is included in a prosthetic component (12, figure 2).
Regarding claim 24, Nguyen et al. disclose determining the alignment measurement of the leg includes using the first angle to calculate a frontal plane knee angle of the leg (figure 1A). Regarding claim 26, Nguyen et al. in view of Roche et al. disclose displaying (via 108 of Roche) at least one of the frontal plane knee angle and the sagittal plane knee angle on the display (figure 1A of Nguyen and figure 3D of Roche).
Regarding claim 27, Nguyen et al. disclose moving the leg through at least one second movement (¶45 “rotating and/or positioning the patient’s femur in a number of different position”); generating measurement data corresponding to the at least one second movement via the measurement system coupled to the leg (¶34-35, ¶41-42, ¶45); and using the measurement data corresponding to the at least one second movement, determining a transverse plane knee angle of the leg (figure 1A).
Regarding claim 28, Nguyen et al. in view of Roche et al. disclose displaying (via 108 of Roche) at least one of the frontal plane knee angle and the transverse plane knee angle on the display (figure 1A of Nguyen and figure 3D of Roche).
Regarding claim 29, Nguyen et al. disclose the at least one first movement includes rotating the leg about a joint line of the leg and wherein the at least one second movement includes rotating a tibia of the leg relative to a femur of the leg (¶45).
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Nguyen et al. (US 2015/0342516) in view of Roche et al. (US 2012/0232834) in view of Stein (US 2014/0288464) in further view of Fitz (US 2013/0310841).
Regarding claim 23, Nguyen et al. in view of Roche et al. and Stein fail to expressly teach or disclose a step of inserting the tibial stem into an opening that is drilled into the tibia. Fitz discloses a step of drilling (¶92) a tibia (¶92) prior to inserting the tibial stem into the tibia as this is a standard operating procedure/practice (¶92).
Accordingly, it would have been obvious to one of ordinary skill in the art at the time of filing to have constructed the method to include a step of drilling an opening into the tibia for insertion of the tibial stem as taught by Fitz as this is a standard operating procedure/practice and would ease insertion of the tibial stem into the tibia.
Claims 36 and 38-40 are rejected under 35 U.S.C. 103 as being unpatentable over Nguyen et al. (US 2015/0342516) in view of Roche et al. (US 2012/0232834)
Regarding claim 36, Nguyen et al. disclose a method of measuring leg alignment, comprising moving a leg through at least one first movement (¶45); generating measurement data corresponding to the at least one first movement via a measurement system (10 + 100, figure 1A) included in a prosthetic knee joint (12) coupled to the leg (figure 3A); using the measurement data corresponding to the at least one first movement, determining a first alignment measurement of the leg (figure 1A, ¶28-30, ¶32, ¶37, ¶42). Nguyen et al. fails to expressly teach or disclose displaying the first alignment measurement of the leg on a display and the measurement system is included in a permanent prosthetic knee joint coupled to the leg. Roche et al. teach the use of a display (108, figure 3D) to display alignment measurement of the leg on the display (figure 3D, ¶19, ¶44). Additionally, Roche et al. disclose the measurement system is included in a permanent prosthetic knee joint (500, figure 5, ¶63-64) coupled to the leg or alternatively can be used in a trial/temporary prosthetic knee joint (300, figures 3A, 3C-3D, ¶44) and is an equivalent structure known in the art. Therefore, because these two measurement system components were art-recognized equivalents at the time the invention was made, one of ordinary skill in the art would have found it obvious to substitute the permanent prosthetic of Roche et al. in for the trial of Nguyen et al. discloses the claimed invention except that the prosthesis is temporary instead of permanent.
Accordingly, it would have been obvious to one of ordinary skill in the art at the time of filing to have provided the method of Nguyen et al. to include a display for displaying the alignment measurement of the leg as taught by Roche et al. as it provides additional visual confirmation of the knee alignment. Regarding claim 38, Nguyen et al. in view of Roche et al. disclose moving the leg through at least one second movement (¶45 “rotating and/or positioning the patient’s femur in a number of different position” of Nguyen); generating measurement data corresponding to the at least one second movement via the measurement system included in the prosthetic knee joint coupled to the leg (¶34-35, ¶41-42, ¶45 of Nguyen et al.); using the measurement data corresponding to the at least one second movement, determining a second alignment measurement of the leg (figure 1A, ¶45 of Nguyen); and displaying the first alignment measurement of the leg and the second alignment measurement of the leg on the display (108, figure 3D, ¶19, ¶44 of Roche).
Regarding claim 39, Nguyen et al. disclose the at least one second movement includes rotating a tibia of the leg relative to a femur of the leg and wherein the second alignment measurement is a transverse plane knee angle (¶45).
Regarding claim 40, Nguyen et al. disclose the first alignment measurement is indicative of an alignment of a femur of the leg relative to a mechanical axis of the leg or an alignment of a tibia of the leg to the mechanical axis of the leg (figure 1A).
Allowable Subject Matter
Claims 31-35 are allowed.
Claim 25, 30 and 37 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
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 MATTHEW JAMES LAWSON whose telephone number is (571)270-7375. The examiner can normally be reached Mon - Fri 6:30-3:00.
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/MATTHEW J LAWSON/Primary Examiner, Art Unit 3619