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 has amended claims 1 and 7. Claim objections have been withdrawn.
Applicant has amended claim 1. 35 U.S.C. 112 rejection has been withdrawn.
Applicant’s arguments, filed August 7, 2025, with respect to the rejection(s) of claim(s) 1-8 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made. Please direct attention to rejection below, specifically reference -Bojarski regarding the amended limitations including
calculating a mechanical axis and an anatomical axis of the femur and the tibia in the system separately for determining an angle needed for correction of the varus and valgus deformity via the software installed in the system
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 1-8 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Pub. No. 2009/0131941 to Park et al. in view of U.S. Patent Pub. No. 2011/0029091 to Bojarski et al. in view of U.S. Patent Pub. No. 2012/0041446 to Wong et al.
As to Claim 1, Park discloses a method [0014] for fabricating a patient-specific cut and screw guide for a high tibial osteotomy to address a varus and valgus deformity occurring in a patient’s knee joint by detecting an angular deformity in a femur and a tibia [0015-0017]. The method includes the steps of scanning the patient's knee joint via a radiological image scanning device for obtaining a plurality of radiological images of the femur and the tibia in a jpeg format [0035], transferring the plurality of radiological images of the femur and the tibia in jpeg format to a system installed with a software module for detecting the angular deformity of the varus and the valgus deformity in the femur and the tibia of the patient [0015, 0018, 0035, 0040], calculating a mechanical axis and an anatomical axis of the femur and the tibia in the system for determining correction of the varus and valgus deformity via the software installed in the system [0015, 0041-0044, 0049, 0061], and modelling of obtained results on a per-patient basis for producing the cut and screw guide (33) from a medically biocompatible material by a rapid production machine [0016, 0020, 0036, 0053-0056].
As to Claim 3, Park discloses a cut and screw guide (33) produced by a method according to claim 1 [0016, 0020, 0036, 0053-0056].
As to Claim 4, Park discloses a cut and screw guide (33) comprising a proximal guide section and a distal guide section ([0036-0039], Fig. 3B).
As to Claim 7, Park discloses a cut and screw guide (33) characterized by comprising a cut area with adjustable angle tailored to person where saw goes into cut and screw guide for cutting bone (osteotomy) and angled based on angle measured in software-based system [0037-0038, 0044, 0061].
As to Claim 8, Park discloses a cut and screw guide (33) wherein the guide further comprises plate housing in a manner to place a plate into the proximal guide section and the distal guide section (fixation of proximal and distal portions of implant described in [0038]).
As to Claims 1-8, Park discloses the claimed invention except for calculating a mechanical axis and an anatomical axis of the femur and the tibia in the system separately for determining an angle needed for correction of the varus and valgus deformity via the software installed in the system, wherein the cut and screw guide is produced by 3D printing, comprising a process step of performing the modelling by solid works program, the guide further comprising tibia support flaps in flap form to provide holding of cut and screw guide onto tibia bone or skin during operation, and wherein the guide further comprises a kishner wire guide holes to provide fixation of cut and screw guide to bone.
Bojarski discloses a method to detect curve in a bone for a correction cut in the bone and produce a personalized cut and screw guide for an implanting method of a high tibial osteotomy operations for treatment of varus and valgus deformities occurring in a knee joint [0006-0007] including calculating a mechanical axis and an anatomical axis of the femur and the tibia in the system separately [0117-0118] for determining an angle needed for correction of the varus and valgus deformity via the software installed in the system [0118, 01210122, 0124-0125] in order to provide a precise degree of correction required to correct the varus and valgus deformity of the patient [0118].
Wong discloses a method to detect curve in a bone for a correction cut in the bone and produce a personalized cut and screw guide for an implanting method of a high tibial osteotomy operations for treatment of varus and valgus deformities occurring in a knee joint [0018-0019, 0177, 0181], wherein the cut and screw guide is produced by 3D printing [0391, 0660]. The process step of performance of the modelling can be performed by the solid works program [0639, 0641]. The guide (2320, [0504-0508]) further comprises tibia support flaps (2326) in flap form (Fig. 15B) to provide holding of cut and screw guide onto tibia bone or skin during operation [0507]. The guide further comprises a kishner wire guide holes to provide fixation of cut and screw guide to bone [0070, 0369, 0394] in order to provide a method for automated construction of the implant based on the custom modeling data [0391] and means for securely fixating the guide to the target bone surface [0507].
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the method and cut and screw guide of Park with the angle correction determination of Bojarski in order to provide a precise degree of correction required to correct the varus and valgus deformity of the patient, and with the 3D printing and guide fixation modification of Wong in order to provide a method for automated construction of the implant based on the custom modeling data and means for securely fixating the guide to the target bone surface.
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 CHRISTOPHER J BECCIA whose telephone number is (571)270-7391. The examiner can normally be reached Mon - Fri 8:30-5:00.
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/CHRISTOPHER J BECCIA/Primary Examiner, Art Unit 3775