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 .
Information Disclosure Statement
In the Information Disclosure Statement of October 8, 2024, several references were not considered because the respective dates (37 CFR § 1.98(b)(5); MPEP § 609.04(a)I) are not indicated.
Abstract
The abstract of the disclosure is objected to because on line 7, --of-- should be inserted after “acetabulum”. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text (MPEP § 608.01(b)).
Specification
The disclosure is objected to because of the following informalities: At the beginning of the specification, the status of the parent, grandparent, and great-grandparent applications should be updated. 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.
Claims 65-70, 73-82, and 84-86 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by Hladio et al., US 2014/0275940 A1, which discloses a method of performing a hip joint replacement procedure, the method comprising positioning a femur in an initial position relative to a pelvis (Figures 4-6; paragraphs 0023, 0025, 0041-0042, 0059), coupling a femoral fixation structure to the femur (Figures 2, 4-5, 10; paragraphs 0035, 0067-0068, 0071+), registering a point of the femoral fixation structure (Figures 3, 7; paragraphs 0026-0027, 0029-0030, 0045, 0058), inserting an acetabular shell into an acetabulum of the pelvis (paragraphs 0044, 0078-0080), registering a hip center after insertion of the acetabular shell (paragraphs 0046, 0050-0051, 0054, 0059-0060), repositioning the femur within a range of the initial position (Figure 6; paragraphs 0023-0024, 0051, 0055, 0059), and registering the point of the femoral fixation structure after insertion of the acetabular shell (paragraphs 0044-0046, 0060, 0080).
Regarding claims 66-68, the femur is repositioned in a continuum of angles within the range of ±20° flexion and rotation and ±15° abduction in order to establish sufficient accuracy (Figure 4; paragraphs 0051, 0059-0060); moreover, many patients have limited angular ranges of movement (paragraph 0083). Regarding claims 69-70, the initial position of the femur is in a neutral flexion and a standing position of the patient (Figure 7; paragraphs 0020, 0042). Regarding claims 73, 76, 78, and 86, the femoral fixation structure 1002 is low profile and plate-like in nature (Figure 10; paragraphs 0043, 0067-0068) and preferably positioned on the greater trochanter (Figure 2; paragraph 0067). Regarding claims 74-75, a display or graphical user interface (GUI) indicates when the femur is in the same position before and after inserting the acetabular shell into the acetabulum, and registering the point of the femoral fixation structure after inserting the acetabular shell comprises confirming leg length, joint offset, and rotational orientation of the femoral neck (Figures 4-6; abstract; paragraphs 0001, 0008-0009, 0026, 0034, 0042, 0045, 0060, 0080).
Regarding claim 77, the system corrects for changes in relative orientation by a virtual rotation about a center of rotation (paragraphs 0055, 0059-0060, 0079). Regarding claims 79 and 82, stored and displayed metrics include vectors along a superior-inferior direction or axis for leg lengths and vectors along a medial-lateral direction or axis for joint offsets (Figure 5; paragraphs 0020-0021, 0041+, 0054). Regarding claims 80-81, leg length and joint offset are more sensitive to abduction angle (paragraphs 0081-0083) and less sensitive to rotation about a mechanical axis of the femur (paragraphs 0055, 0059-0060). Regarding claims 84-85, a surgeon exchanges or repositions the acetabular shell based on goals from a pre-operative image and to adjust leg length and joint offset (Figure 6; paragraphs 0003, 0042, 0044, 0060, 0080).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 71-72 and 83 are rejected under 35 U.S.C. 103 as being unpatentable over Hladio et al., US 2014/0275940 A1. Regarding claims 71 and 83, displaying an error message if a joint angle and/or leg length associated with subluxation exceeds a threshold value or limit would have been obvious to the ordinary practitioner at the effective filing date of the instant invention in order to initiate corrections (paragraphs 0024-0025, 0081-0083). Regarding claims 71-72, displaying guidance on altering femoral angulation would likewise have been obvious in order to facilitate such corrections (paragraphs 0081-0083: “clinical adjustments”; “ ‘cone of stability’ ”).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to David H. Willse, whose telephone number is 571-272-4762. The examiner can normally be reached on Monday through Thursday. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor Melanie Tyson can be reached at telephone number 571-272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DAVID H WILLSE/ Primary Examiner, Art Unit 3774
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