DETAILED ACTION
The following is a non-final office action is response to communications received on 07/19/2024. Claims 1-18 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 .
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 11,730,601. The elements of the instant application are to be found in the Patent and therefore are anticipated. Although the conflicting claims are not identical, they are not patentably distinct from each other because the Patent and the instant application all recite the same basic structure with a permutation of similar elements throughout.
Regarding Claims 1 & 6, patent claim 1 recites the same limitations.
Regarding Claims 2 & 13, patent claim 8 recites the same limitations.
Regarding Claim 3, patent claim 2 recites the same limitations.
Regarding Claim 4, patent claim 3 recites the same limitations.
Regarding Claim 5, patent claim 4 recites the same limitations.
Regarding Claim 7, patent claim 5 recites the same limitations.
Regarding Claim 8, patent claim 6 recites the same limitations.
Regarding Claim 9, patent claim 7 recites the same limitations.
Regarding Claim 10, patent claim 8 recites the same limitations.
Regarding Claim 11, patent claim 10 recites the same limitations.
Regarding Claim 12, patent claim 11 recites the same limitations.
Regarding Claim 14, patent claim 12 recites the same limitations.
Regarding Claim 15, patent claim 13 recites the same limitations.
Regarding Claim 16, patent claim 14 recites the same limitations.
Regarding Claim 17, patent claim 15 recites the same limitations.
Regarding Claim 18, patent claim 16 recites the same limitations.
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) 1-6, 9-13 & 16-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nardini et al. (US 2013/0053968) in view of Bateman et al. (US 5,879,404).
Regarding Claim 1, Nardini discloses the invention substantially as claimed. Nardini teaches a method for manufacturing an orthopedic prosthetic (100), the method comprising:
determining a position of an augment (104) on an outer wall (facing the native socket) of a manufactured shell component (102), the position corresponding to a positive contour of a patient's bone when the manufactured acetabular shell component is positioned in a target orientation (implanted orientation as shown in Fig 1) relative to the patient's bone [0014], the target orientation defining an inclination angle (i.e., aligned with the native socket joint) corresponding to a predetermined inclination angle (i.e., the intended angle required for proper joint operation) or a version angle corresponding to a predetermined version angle; and
additively manufacturing [0014] & [0018] the augment (104) coupled to the outer wall (Fig 1) of the manufactured acetabular shell component (102) at the position on the outer wall, wherein the augment 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].
However, Nardini does not specifically disclose wherein the manufactured shell is an acetabular shell for implantation in the acetabulum.
Bateman teaches an acetabular cup and method of making an acetabular cup in the same field of endeavor. Said acetabular cup comprises a concave shell (12) and liner (11) which together articulate a spherically shaped femoral head component to form a ball and socket joint (Col 1: lines 13-21).
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 teachings of Nardini to the acetabular shell component, as taught by Bateman, in order to create a patient-specific acetabular shell configured to fill the patient-specific gaps that exist between the prosthetic shell device 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 to the acetabulum would be obvious to one of ordinary skill in the art.
Regarding Claim 2, Nardini discloses the invention substantially as claimed. Nardini teaches an orthopedic prosthetic component comprising:
a manufactured shell component (102) having an outer wall (facing the outer socket), wherein the outer wall of the manufactured acetabular shell component comprises a distal rim (shown) and an outer surface (shown) that extends from the distal rim, and wherein the distal rim defines a component axis (shown); and
an augment (104) coupled to the outer wall of the manufactured acetabular shell component (Fig 1), wherein the augment comprises an outer surface that defines a customized patient-specific negative contour shaped to conform to a positive contour of a patient's bone [0014], and wherein the position of the augment fixes an orientation (i.e., the implanted orientation) of the component axis relative to the positive contour of the patient's bone [0014], and the orientation defines an inclination angle (i.e., aligned with the native socket joint) that corresponds to a predetermined inclination angle (i.e., the intended angle required for proper joint operation) or a version angle that corresponds to a predetermined version angle.
However, Nardini does not specifically disclose wherein the manufactured shell is an acetabular shell for implantation in the acetabulum.
Bateman teaches an acetabular cup and method of making an acetabular cup in the same field of endeavor. Said acetabular cup comprises a concave shell (12) and liner (11) which together articulate a spherically shaped femoral head component to form a ball and socket joint (Col 1: lines 13-21).
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 teachings of Nardini to the acetabular shell component, as taught by Bateman, in order to create a patient-specific acetabular shell configured to fill the patient-specific gaps that exist between the prosthetic shell device 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 to the acetabulum would be obvious to one of ordinary skill in the art.
Regarding Claim 3, the combination (Nardini) teaches wherein the method further comprises identifying the positive contour of the patient's bone based on one or more medical images of the patient's bone [0014].
Regarding Claim 4, the combination (Nardini) 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 [0014].
Regarding Claim 5, the combination (Nardini) teaches wherein the method further comprises capturing the one or more medical images of the patient's bone [0014], wherein identifying the positive contour comprises identifying the positive contour in response to capturing the one or more medical images [0014].
Regarding Claims 6 & 13, the combination (Nardini) teaches wherein the outer wall of the manufactured acetabular shell component comprises a distal rim (shown) and an outer surface (shown) that extends from the distal rim, and wherein the augment extends outwardly from the outer surface at a position adjacent to the distal rim (Fig 1).
Regarding Claims 9 & 16, the combination (Nardini) teaches wherein the positive contour of the patient's bone defines a void in the patient's bony geometry [0014].
Regarding Claims 10 & 18, the combination (Nardini) teaches wherein the augment comprises an additively manufactured [0014] metallic component [0015].
Regarding Claim 11, the combination (Nardini) teaches wherein the augment comprises a porous outer surface [0015]
Regarding Claim 12, the combination discloses the invention substantially as claimed. Further, the combination teaches wherein the augment is coupled to the outer wall of the shell. However, the combination does not disclose wherein the manufactured acetabular shell component comprises a porous coating coupled to the outer wall. Bateman teaches wherein the outer surface of the acetabular shell comprises a porous coating to encourage bone ingrowth (Col 3: lines 22-25). 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 porous coating as taught by Bateman to the outer surface of the acetabular shell of the combination in order to encourage bone ingrowth and therefore enhance implant fixation.
Regarding Claim 17, the combination discloses the invention substantially as claimed. However, the combination does not disclose wherein the manufactured acetabular shell component comprises a forged metallic component or a machined metallic component. Bateman teaches wherein the acetabular shell can be manufactured form known techniques including machining and molding (Col 4: lines 11-13) in order to properly size and shape the device. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to utilize a machined of forged acetabular shell, as taught by Bateman, in the construction of the device of the combination in order to properly size and shape the device. Further it would be obvious to use well-known manufacturing techniques in the construction of any implant device.
Claims 7, 8, 14 & 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nardini et al. (US 2013/0053968) in view of Bateman et al. (US 5,879,404) and in further view of Bojarski et al. (US 2011/0087332).
Regarding Claims 7, 8, 14 & 15, as set forth supra, the combination discloses the invention substantially as claimed. However, the combination does not specifically disclose wherein the positive contour of the patient's bone comprises a bony landmark of the patient's bony geometry and a transverse acetabular ligament landmark.
Bojarski teaches patient-specific implants in the same field of endeavor. Said implants are modeled pre-operatively [0209] and based on surgical imaging data [0264] in order to best match the patient’s biological features [0203]. This system can be utilized in the manufacture of hip implants in order to negatively match the targeted bone-facing surface [0238]. The model can be utilized to reflect any cut or uncut surface of the structure including any bone ridges, plateaus, cartilage surfaces, and/or ligament surfaces [0275]. Lastly, if desired, the implant can be designed to stay clear of ligament structures [0334].
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to utilize the pre-operative planning/modelling, as taught by Bojarski, to further enhance the pre-operative planning of the combination and fabricate an acetabular shell with a bone-facing side that matched any of the underlying bony landmarks and/or any of the underlying ligaments (e.g., the transverse acetabular ligament). Said matching would enhance fixation of the device, minimize resection, and best mimic the remaining native geometry of the acetabular space.
Conclusion
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