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 Objections
Claims 1, 2, 6-8 and 17 objected to because of the following informalities: “AP taper”. The Examiner suggests using the full description of the “AP” such as, --- first and second anterior-posterior taper---. Appropriate correction is required.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the second AP taper must be shown or the feature(s) canceled from the claim(s). No new matter should be entered. Does the two taper lines at the Tp is the second AP taper? If yes, looking at the drawing (Fig. 10) it seems like the second AP taper is part of the transition point and is not extending from the transition point. Claim 1 says the second AP taper is extending from the transition point and not part of the transition point. Correction or clarification is required.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-15 and 17 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The “first AP taper” and “the second AP taper” are indefinite, since, it is not clear what is tapering. Does the AP taper is the area tapering at the lateral side, as shown in Fig. 10?
Regarding claims 7 and 8, The AP taper angle has an angle relative to what? To the longitudinal axis of the implant? Correction is required.
Regarding claims 15 and 20, what does the applicant’s representative means with having “a constant arc of curvature”? Does the perimeter of the medial side from the shoulder towards the distal end is the one having the constant arc of curvature? Correction or clarification is required.
Claim Rejections - 35 USC § 102
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.
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 1-9, 11 and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fridshtand et al US Patent Pub. 2006/0190092 A1.
Fridshtand et al discloses a hip stem implant comprising: a body including an anterior side, a posterior side, a medial side, a lateral side, a shoulder, and a distal tip (see Figs. 1, 2, 11 and 12), the body defining a proximal region and a distal region (see figure below); wherein the anterior and posterior sides include: a first anterior-posterior taper extending toward each other, the first anterior-posterior taper extending from the shoulder to a transition point; a second anterior-posterior taper extending toward each other, the second anterior-posterior taper extending from the transition point to the distal tip; and the second anterior-posterior taper is different from the first anterior-posterior taper. See figure below for the Examiner’s interpretation.
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Regarding claim 2, the AP taper is symmetrical.
Regarding claim 3, see Fig. 1 showing the lateral side (where element 24 is pointing) having a convex lateral outer surface.
Regarding claim 6, see elements 80 and 100 showing that the second AP taper is larger than the first AP taper.
Regarding claims 7 and 8, see paragraph 25 and claim 2.
Regarding claim 9, see paragraph 27, element 60 disclosing the porous coating.
Regarding claim 11, see element 100 as the distal region including a non-porous coated region.
Regarding claim 15, see Fig. 2 disclosing a constant arc at the exterior perimeter of the medial side of the implant in the proximal region.
Regarding claim 4 and 5, the Examiner has a different interpretation of the second AP taper (see below), therefore, the Examiner can select a random point along the length of the stem (see figure below for selected random point) to be called the transition point so it can be positioned at a point between 15 to 25 percent of the total length of the body and also being positioned at a point between 18mm to 35mm from the distal tip.
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Claims 16 and 18-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Serbousek et al US Patent 6,652,591B2.
Regarding claim 16, Serbousek et al discloses a hip stem implant comprising a body including an anterior side, a posterior side, a medial side, a lateral side, a shoulder, and a distal tip (see Figs. 1 and 3). The body defining a proximal region and a distal region; wherein the proximal region includes a porous coated surface (92), see column 9, lines 42-51, the distal region being configured as a non-porous coated region (see Fig. 1), and the anterior and posterior sides of the proximal region further include a plurality of grooves formed therein, the plurality of grooves formed on the anterior side extend to the medial side such that the plurality of grooves wrap around an anterior-medial corner of the body (see Fig. 1 and col. 8, lines 51-53 and Fig. 3 showing how the grooves extends to the medial side).
Regarding claim 18, see Fig. 2A disclosing that the connection between surfaces 76, 82 and 80 form a concave surface.
Regarding claim 19, see Fig. 1 disclosing angled downward grooves extending from the lateral side to the medial side.
Regarding claim 20, see Fig. 3 showing a constant arc at the exterior perimeter of the medial side of the implant in the proximal region.
Claim Rejections - 35 USC § 103
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.
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 10, and 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over Fridshtand et al US Patent Pub. 2006/0190092 A1 in view of Serbousek et al US Patent 6,652,591B2.
Fridshtand et al discloses the invention substantially as claimed. However, Fridshtand et al does not disclose hydroxyapatite, a plurality of grooves in the anterior and posterior sides, a plurality of angled grooves extending downward from the lateral side to the medial side and that the grooves extends to the medial side.
As disclosed above the Serbousek et al reference discloses all the missing limitations from the Fridshtand et al reference. See Figs. 1, 1A and 3 and the structural limitations of the implant above.
It would have been obvious to one ordinary skill in the art to substitute the one single groove of the Fridshtand et al reference with the multiple declined grooves of the Serbousek et al for the purpose of promoting the anchoring of the implant during installation and to promote the fixation of the implant after the implant is set in position.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Serbousek et al US Patent 6,652,591B2 in view of Fridshtand et al US Patent Pub. 2006/0190092 A1.
Serbousek et al discloses the invention substantially as claimed. However, Serbousek et al does not disclose a first AP taper, a second AP taper and wherein the second AP taper is different from the first AP taper.
As disclosed above the Fridshtand et al reference discloses all the missing limitations from the Serbousek et al reference.
It would have been obvious to one ordinary skill in the art to modify the proximal and distal regions of the Serbousek et al implant by forming two distinct AP taper as disclosed by the Fridshtand et al reference in order to create a strong attachment between the implant and the intramedullary canal of the patient.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALVIN J STEWART whose telephone number is (571)272-4760. The examiner can normally be reached Monday-Friday 8:30AM-6PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Barrett can be reached at 571-272-4746. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALVIN J STEWART/Primary Examiner, Art Unit 3799 9/10/26
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