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 § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claim 13 recites the limitation "the standard setting step”. There is insufficient antecedent basis for this limitation in the claim. The limitation should be amended to claim “the measurement standard setting step” in order to be consistent with claim 1.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-14 are rejected under 35 U.S.C. 102(a)(1) and 102 (a)(2) as being anticipated by Wuestemann et al. (2013/0197866) “Wuestemann”.
Regarding claim 1, Wuestemann discloses femoral stem design method (par. 0007 and Figs. 9-11) comprising: a data collection step of collecting femur data from a plurality of patients (par. 0029 and Fig. 1C disclose step A comprising CT scans of femurs are inputted into a database); a measurement standard setting step of setting a standard for designing a femoral stem with respect to the femur data of the plurality of patients collected in the data collection step (par. 0029 discloses step B comprising determining a boundary between cortical and cancellous bones); a measurement step of measuring a predetermined part of the femur from the femur data of the plurality of patients (par. 0029 discloses step C comprising measurements are determined at increments along the anatomic axis of the femurs); a dimension determination step of determining a dimension of each part of a plurality of implants to be inserted into the femur (par. 0009 discloses revising dimensions of femurs based on the data; pars. 0062-0073 disclose determining dimensions) and a shape determination step of determining shapes of the plurality of implants according to the dimension of the plurality of implants determined in the dimension determination step (par. 0029 discloses step G comprising designing a shape of the femoral stems), wherein the measurement standard setting step comprises: a boundary setting step of setting a boundary that distinguishes the cortical bone and the cancellous bone from the femur data of the plurality of patients (pars. 0029-0030 disclose determining the boundary between cancellous and cortical bones); and an axis setting step of setting an axis (Axis B; Fig. 6) extending from the proximal part to the distal part of the femur (par. 0034 discloses defining an axis extending from proximal part distally to a distal part).
Regarding claim 2, Wuestemann discloses wherein the measurement step comprises: a step of measuring a width from the axis to a lateral boundary at a position spaced by a predetermined distance proximally apart from the lesser trochanter of the femur along the axis; a step of measuring a width from the axis to a medial boundary; and a step of measuring a width from the medial boundary to the lateral boundary at a position spaced by a predetermined distance distally apart from the lesser trochanter of the femur (par. 0035 and Fig. 6).
Regarding claim 3, Wuestemann discloses wherein the measurement step further comprises a step of measuring a distance from the axis to a center of the femoral head and a distance from the lesser trochanter to the center of the femoral head (section 1; Fig. 15).
Regarding claims 4-6, Wuestemann discloses wherein the dimension determination step comprises a step of determining a plurality of proximal widths on the basis of the widths from the axis to the lateral boundary and the medial boundary measured in the measurement step, and the plurality of proximal widths determined in the dimension determination step gradually increase or decrease; wherein the dimension determination step further comprises a step of determining a plurality of distal widths on the basis of the width from the medial boundary to the lateral boundary, and the determined plurality of distal widths gradually increase or decrease; wherein the plurality of proximal widths and the plurality of distal widths determined in the dimension determination step increase or decrease at regular intervals (par. 0019 and Fig. 6 disclose measurements taken at gradual and regular increments extending from proximal to distal direction).
Regarding claim 7, Wuestemann discloses wherein the dimension determination step further comprises a step of determining lengths of the plurality of implants so that the lengths of the implants change in proportion to the determined proximal widths (par. 0047 and 0086 disclose custom lengths).
Regarding claims 8-10, Wuestemann discloses wherein the shape determination step determines the shapes of the implants so that a medial part of each of the implants increases as a size of the implant increases, and the shape determination step comprises: a standard setting step for setting a part serving as a standard for determining the shapes of the implants; a medial curvature determination step of determining a curvature of the medial part extending distally in a curve from a medial end of each of the implants; and an extension length determination step of determining a length of the curvature portion extending distally with the curvature from the medial end; wherein the medial curvature determination step determines the curvature so that respective curvature portions of the plurality of implants extend with the same curvature; wherein the extension length determination step determines a plurality of extension lengths so that lengths of the curvature portions increase as the proximal widths of the implants increase (pars. 0036, 0042 and 0086 and Figs. 9-13 discloses measuring the medial and lateral curvatures which depends on the length of the stem to enhance femoral fit).
Regarding claims 11-12, Wuestemann discloses wherein the shape determination step further comprises a connection portion curve determination step of determining a shape from an end of the curvature portion to an end of a distal part of each of the implants; wherein the connection portion curve determination step determines the shape from a distal end of the curvature portion to the end of the distal part of the implant to correspond to an anatomical shape of the inside of the femur (Figs. 12-13).
Regarding claim 13, as best understood, Wuestemann discloses wherein the standard setting step sets the axis and the lesser trochanter as the standard so that the shapes of the plurality of implants are determined to be aligned with respect to the axis and the lesser trochanter (Fig. 6 and par. 0019).
Regarding claim 14, Wuestemann discloses at least one implant having a shape determined by the femoral stem design method of claim 1 (par. 0009 discloses the implants; Figs. 9-11).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YASHITA SHARMA whose telephone number is (571)270-5417. The examiner can normally be reached on 8am-5pm M-Th; 8am-4pm Fri (MT).
If attempts to reach the examiner by telephone are unsuccessful, the examiner' s supervisor, Jerrah Edwards, can be reached at 408-918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/YASHITA SHARMA/
Primary Examiner, Art Unit 3774