DETAILED ACTION
The following is a non-final office action is response to communications received on 03/04/2024. Claims 1-10 are currently pending and addressed below.
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 § 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.
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.
Claim(s) 1-5 & 7-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schroeder (US 6,682,567) in view of Nardini et al. (US 2013/0053968).
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Regarding Claim 1, Schroeder discloses the invention substantially as claimed. Schroeder teaches a method for manufacturing an orthopedic prosthetic, the method comprising: additively manufacturing (Col 4: lines 15-26) a monoblock acetabular shell (12) component.
However, Schroeder does not disclose wherein the method comprises identifying a positive contour of a patient’s bone based on one or more medical images of the patient’s bone; wherein the monoblock acetabular shell component comprises an adjunct extending outwardly from the monoblock acetabular shell component, wherein the adjunct comprises an outer surface that defines a customized patient-specific negative contour shaped to conform to the positive contour of a patient’s bone.
Nardini teaches a method of manufacturing a patient specific joint prosthesis in the same field of endeavor. Said manufacturing method comprising identifying a positive contour of a patient’s bone [0014] based on one or more medical images of the patient’s bone [0014]; wherein the shell component (102) comprises an adjunct (104) extending outwardly from the monoblock acetabular shell component (Fig 1), wherein the adjunct comprises an outer surface that defines a customized patient-specific negative contour shaped to conform to the positive contour of a patient’s bone ([0014] and [[0018]). Further, Nardini teaches that the adjunct can be utilized to treat any ball and socket joint of the body [0011].
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It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to apply the patient specific adjunct and teachings, as taught by Nardini, to the acetabular shell component, as taught by Schroeder, in order to create a patient-specific acetabular shell configured to fill the patient-specific gaps that exist between the prosthetic acetabular shell and the bone surface. As Nardani teaches that the implant can be used to treat any ball and socket joint of the body [0011], applying Nardini to the acetabulum would be obvious to one of ordinary skill in the art.
Regarding Claim 2, the combination teaches wherein identifying the positive contour comprises generating a three-dimensional model of the patient’s bone based on the one or more medical images of the patient’s bone (Nardini [0014]).
Regarding Claim 3, the combination teaches wherein the method further comprises capturing the one or more medical images of the patient’s bone, wherein identifying the positive contour comprises identifying the positive contour in response to capturing the one or more medical images (Nardini [0014] & [0018]).
Regarding Claim 4, the combination teaches wherein additively manufacturing the monoblock acetabular shell component comprises additively manufacturing a solid substrate (Schroeder 22), a porous outer layer (Schroeder 20) coupled to the solid substrate, and a porous inner layer (Schroeder 18) coupled to the solid substrate (Fig 2), wherein the adjunct (Nardini 104) is coupled to the porous outer layer, and wherein each of the porous outer layer and the porous inner layer has a porosity greater than the solid substrate (as the solid substrate 22 is non-porous).
Regarding Claim 5, the combination teaches wherein additively manufacturing the monoblock acetabular shell component further comprises additively manufacturing (Schroeder Col 4: lines 38-50) an inner bearing (14) coupled to the porous inner layer, wherein the inner bearing comprises a bearing surface.
Regarding Claim 7, the combination teaches wherein the method further comprises manufacturing an inner bearing (14) coupled to (Schroeder Col 4: lines 52-53) the porous inner layer (18) of the monoblock acetabular shell component, wherein the inner bearing comprises a bearing surface.
Regarding Claim 8, the combination teaches wherein manufacturing the inner bearing (14) comprises injection molding the inner bearing or compression molding the inner bearing (Schroeder Col 4: lines 38-57).
Regarding Claim 9, the combination teaches wherein the inner bearing comprises a polymeric material (Schroeder Col 4: lines 41-42).
Regarding Claim 10, the combination teaches wherein additively manufacturing the monoblock acetabular shell component comprises forming an aperture (Nardini 210) defined through the outer surface of the adjunct (Nardini Fig 5), wherein the aperture is sized to receive a fastener (Nardini [0016]).
Allowable Subject Matter
Claim 6 is 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
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Dines et al., Novel Solution for Massive Glenoid Defects in Shoulder Arthroplasty: A Patient-Specific Glenoid Vault Reconstruction System, The American Journal of Orthopedics, pgs. 104-108, March 2017. Dines et al. teaches a method for manufacturing an orthopedic prosthetic, the method comprising: identifying a positive contour of a patient’s bone based (pg.105) on one or more medical images of the patient’s bone (pg. 105); and additively manufacturing (pg. 105) a monoblock shell component, wherein the monoblock shell component comprises an adjunct extending outwardly from the monoblock shell component (pg. 105), wherein the adjunct comprises an outer surface that defines a customized patient-specific negative contour shaped to conform to the positive contour of a patient’s bone (pg. 105).
Stoffelen et al., The use of 3D printing technology in reconstruction of a severe glenoid defect: a case report with 2.5 years of follow-up, Journal of Shoulder and Elbow Surgery, 2015, pgs. 218-222. Stoffelen et al. teaches a method for manufacturing an orthopedic prosthetic, the method comprising: identifying a positive contour of a patient’s bone based (pgs. 218-219) on one or more medical images of the patient’s bone (pgs. 218-219); and additively manufacturing (pgs. 218-219) a monoblock shell component, wherein the monoblock shell component comprises an adjunct extending outwardly from the monoblock shell component (pgs. 218-219), wherein the adjunct comprises an outer surface that defines a customized patient-specific negative contour shaped to conform to the positive contour of a patient’s bone (pgs. 218-219).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN AINSLEY DUKERT whose telephone number is (571)270-3258. The examiner can normally be reached Mon-Fri 6am-4pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached at (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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/BRIAN A DUKERT/Primary Examiner, Art Unit 3774
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