DETAILED ACTION
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 § 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.
(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.
Claim(s) 1-3, 5-6, 9-12, 14, and 16-17 is/are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being disclosed by Abboud et al. (WO 2023/076398) "Abboud".
Regarding Claim 1, Abboud discloses a stemless implant assembly (Abstract) for a humeral implant assembly (Abstract, humeral component 122), comprising: a cup (stemless shell 314, par. [0126], FIG. 27);
a first fixation device (insert 320, par. [0126], FIG. 27) insertable through a first central bore (opening 318, par. [0126], FIG. 27) of the cup;
and a second fixation device (fastener 324, par. [0126], FIG. 27) insertable through a second central bore (aperture 344, par. [0126], FIG. 28) of the first fixation device (pars. [0126]- [0127]).
Regarding Claim 2, Abboud discloses the stemless implant assembly as recited in claim 1, wherein the first fixation device is a major screw (par. [0127]), and the second fixation device is a minor screw (par. [0127], FIGS. 26-28).
Regarding Claim 3, Abboud discloses the stemless implant assembly as recited in claim 1, wherein the first fixation device is an anti-rotation implant, and the second fixation device is a screw (par. [0127]).
Regarding Claim 5, Abboud discloses the stemless implant assembly as recited in claim 4, wherein the second distal section includes a thread (thread 326, par. [0126], FIG. 26).
Regarding Claim 6, Abboud discloses the stemless implant assembly as recited in claim 1, wherein the first central bore extends between a rim (ring structure 342, FIG. 27) and a rounded base (convex portion 316, FIG. 27) of the cup (pars. [0126]- [0127]).
Regarding Claim 9, Abboud discloses the stemless implant assembly as recited in claim 8, wherein the second fixation device includes a thread (threads 326, par. [0126], FIG. 27).
Regarding Claim 10, Abboud discloses the stemless implant assembly as recited in claim 1, wherein the cup includes a cylindrical shaped body having a threaded inner diameter wall and a smooth outer diameter wall (par. [0127], FIG. 28).
Regarding Claim 11, Abboud discloses a humeral implant assembly (Abstract, humeral component 122) for an arthroplasty implant system (Abstract), comprising: an articular implant (ball 122, pars. [0106] and [0126]);
and a stemless implant assembly adapted to establish a convertible platform for receiving the articular implant (Abstract, pars. [0106] and [0126]);
wherein the stemless implant assembly includes a cup (stemless shell 314, par. [0126], FIGS. 26-28), a first fixation device (insert 320, par. [0126], FIGS. 26-28) insertable through the cup, and a second fixation device (fastener 324, par. [0126], FIGS. 26-28) insertable through the first fixation device.
Regarding Claim 12, Abboud discloses the humeral implant assembly as recited in claim 11, wherein the articular implant includes a concave articular surface (concave portion 334, par. [0126], FIGS. 26 and 28).
Regarding Claim 14, Abboud discloses the humeral implant assembly as recited in claim 11, wherein the cup includes a cylindrical shaped body having a threaded inner diameter wall and a smooth outer diameter wall (par. [0127], FIG. 28).
Regarding Claim 16, Abboud discloses the humeral implant assembly as recited in claim 11, wherein the first fixation device is an anti-rotation implant that includes a tapered body having at least two barbs (serrated fins 322, FIGS. 27 and 28), and further wherein each of the at least two barbs includes a ledge (serrated fins 322 outwardly deployed by action of thread 326, causing circumferential shape, par. [0126]) extending circumferentially around at least a portion of the tapered body (par. [0126], FIGS. 27 and 28).
Regarding Claim 17, Abboud discloses the humeral implant assembly as recited in claim 11, wherein the second fixation device is a screw that includes an outer diameter wall and a thread circumferentially disposed about at least a portion of the outer diameter wall (pars. [0126]- [0127], FIGS. 27 and 28).
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.
Claim(s) 4, 7-8, 13, 15, and 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Abboud et al. (WO 2023/076398) "Abboud".
Regarding Claim 4, the main embodiment of Abboud does not disclose a first and second
distal section with different distances from the cup. However, another embodiment of Abboud discloses the stemless implant assembly as recited in claim 1, wherein, in an assembled condition of the stemless implant assembly, a first distal section of the first fixation device is a first distance from the cup, and a second distal section of the second fixation device is a second distance from the cup, and further wherein the second distance is greater than the first distance (par. [0128], FIGS. 29-32). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by the main embodiment of Abboud to include a first and second distal section with different distances from the cup in order to have a specified section for passing sutures and another section for securing the implant (par. [0126]).
Regarding Claim 7, the main embodiment of Abboud does not disclose a rim including a flange. However, another embodiment of Abboud discloses the stemless implant assembly as recited in claim 6, wherein the rim (ring structure 342, FIGS. 27 and 28) includes a flange (cavity 510 to accept insert 512, par. [0138], FIGS. 45 and 46). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by the main embodiment of Abboud to include a rim with a flange in order to have a port to accept and secure other biocompatible devices (par. [0138]).
Regarding Claim 8, the main embodiment of Abboud does not disclose a first fixation device including a thread or barb. However, another embodiment of Abboud discloses the stemless implant assembly as recited in claim 1, wherein the first fixation device includes a thread (proximally threaded portion 352, par. [0128], FIG. 30) or a barb. It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by the main embodiment of Abboud to include a first fixation device with a thread or barb in order to promote bony ingrowth (par. [0126]).
Regarding Claim 13, the main embodiment of Abboud does not disclose an articular implant with a convex articular surface. However, another embodiment of Abboud discloses the humeral implant assembly as recited in claim 11, wherein the articular implant includes a convex articular surface (hemispherical head 722 with surface 724, par. [0149], FIG. 63). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by the main embodiment of Abboud to include an articular implant with a convex articular surface in order to properly connect to the glenoid component that is adapted to attach to the scapula (par. [0008]).
Regarding Claim 15, the main embodiment of Abboud does not disclose a first fixation device that is a screw with an outer diameter wall and a thread. However, another embodiment of Abboud discloses the humeral implant assembly as recited in claim 11, wherein the first fixation device is a screw that includes an outer diameter wall and a thread circumferentially disposed about at least a portion of the outer diameter wall (proximally threaded portion 352, par. [0128], FIG. 30). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by the main embodiment of Abboud to include a first fixation device that is a screw with an outer diameter wall and a thread in order to promote bony ingrowth (par. [0126]).
Regarding Claim 18, the main embodiment of Abboud does not disclose a first and second distal section with different distances from the cup. However, another embodiment of Abboud the humeral implant assembly as recited in claim 11, wherein, in an assembled condition of the stemless implant assembly, a first distal section of the first fixation device is a first distance from the cup, and a second distal section of the second fixation device is a second distance from the cup, and further wherein the second distance is greater than the first distance. (par. [0128], FIGS. 29-32). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by the main embodiment of Abboud to include a first and second distal section with different distances from the cup in order to have a specified section for passing sutures and another section for securing the implant (par. [0126]).
Regarding Claim 19, the main embodiment of Abboud does not disclose a cup, first fixation device, and second fixation device that are coaxially arranged along a central axis. However, another embodiment of Abboud discloses the humeral implant assembly as recited in claim 11, wherein the cup, the first fixation device, and the second fixation device are coaxially arranged along a central longitudinal axis of the stemless implant assembly (pars. [0006] and [0123], FIGS. 23, 26-28). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by the main embodiment of Abboud to include a cup, first fixation device, and second fixation device that are coaxially arranged along a central axis in order to reduce off-axis forces on the implant (par. [0006]).
Regarding Claim 20, the main embodiment of Abboud discloses a surgical method, comprising: preparing a humerus for receiving a cup of a stemless implant assembly (pars. [0004] and [0006], Abstract);
positioning the cup within the prepared humerus (pars. [0008] and [0006], Abstract);
inserting a first fixation device of the stemless implant assembly through the cup and into a cancellous bone of the humerus (pars. [0008] and [0126]);
but does not disclose inserting the second fixation device through the first fixation device wherein the second fixation device extends further. However, another embodiment of Abboud discloses inserting a second fixation device of the stemless implant assembly through the first fixation device and into the cancellous bone, wherein the second fixation device extends further into the cancellous bone than the first fixation device after the inserting (pars. [0126]- [0127], FIGS. 23 and 27). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by the main embodiment of Abboud to include inserting the second fixation device through the first fixation device wherein the second fixation device extends further into the cancellous bone in order to help compress the stemless portion into the bone, which will help secure the device (par. [0191]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATALIE NICOLE THOMAS whose telephone number is (571)272-0004. The examiner can normally be reached Monday - Friday 8:30am-5pm.
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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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/NATALIE N THOMAS/Examiner, Art Unit 3774
/KATRINA M STRANSKY/Primary Examiner, Art Unit 3700