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 .
Election/Restrictions
Applicant’s election without traverse of Species B, Figures 9A-9H, in the reply filed on 03/28/2026 is acknowledged. However, the applicant asserts that all drawings and related description not grouped in Species A or Species C falls within the scope of the elected species and that for that reason claims 1-20 read on the elected species. However, claim 12 is directed to non-elected species A and claim 14 is directed to non-elected species B.
Claims 12 and 14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a non-elected species, there being no allowable generic or linking claim.
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.
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 1-11, 13, 15-16, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Sikora et al. (US 20150250602 A1) in view of Reed et al. (US 9079263 B2).
Regarding claim 1, Sikora discloses a joint replacement implant (¶0005; 92) comprising: a shaft comprising: a proximal end; a distal end; and a threaded shaft portion (see fig. 1 below); a helical thread disposed about the shaft defining a length of the threaded shaft portion (fig. 1 below illustrates a helical thread disposed about the shaft defining a length of the threaded shaft portion), and an attachment feature at the proximal end of the joint replacement implant (fig. 1 and fig. 3 illustrate an attachment feature 62), wherein: the attachment feature is configured to couple an articular member to the joint replacement implant (fig. 3 illustrates that an attachment feature 62 couples an articular member 22 to the joint replacement implant 92); the articular member comprises at least one artificial articular surface (fig. 1; 26); and the at least one artificial articular surface is shaped to replace at least a portion of a natural articular surface of a joint of a patient (¶0034 discloses that an artificial surface 26 is shaped to replace a portion of a natural articular surface of a joint of a patient e.g. glenoid surface).
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Sikora fails to discloses that the helical thread comprises a concave undercut surface angled towards one of the proximal ends and the distal end of the shaft.
Reed also discloses a shaft (13) comprising: a proximal end (2); a distal end (4); and a threaded shaft portion (12); a helical thread disposed about the shaft defining a length of the threaded shaft portion (see fig. 1). Reed teaches that a helical thread comprises a concave undercut surface angled towards one of the proximal end and the distal end of the shaft (fig. 9 illustrates a helical thread 12 comprising a concave undercut surface angled towards a proximal end of the shaft).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the joint replacement implant of Sikora to include that the helical thread comprises a concave undercut surface angled towards one of the proximal ends and the distal end of the shaft as taught by Reed, in order to have a thread that allows maximum grip of bone and minimizes trauma in comparison to a common thread (Reed col.7 lines 13-16; also see fig. 9).
Regarding claim 2, Sikora in view of Reed discloses the invention as claimed as discussed above with respect to claim 1. Sikora further discloses that the attachment feature comprises at least one of: a post; a Morse taper feature; a passageway; a dovetail feature; a tray feature; a snap-fit feature; and a tab feature (fig. 2-3 illustrates that the attachment feature 62 comprises a passageway 32, ¶0039 discloses that the attachment feature 62 comprises snap-fit features 64 to engage/couple the articular member 22 to the joint replacement implant 20, and ¶0043 discloses that a side wall 94/95 of the shaft has a tapered surface that corresponds to the taper of the passageway 32 of the attachment feature 62 forming a friction fit connection i.e. a morse taper).
Regarding claim 3, Sikora in view of Reed discloses the invention as claimed as discussed above with respect to claim 1. Sikora further discloses that the joint replacement implant further comprises an intermediary component couplably disposed intermediate the attachment feature and the articular member (fig.1 illustrates an intermediary component 42 couplably disposed intermediate the attachment feature 62 and the articular member 22).
Regarding claim 4, Sikora in view of Reed discloses the invention as claimed as discussed above with respect to claim 3. Sikora further discloses that the intermediary component comprises at least one of: an intermediary neck component; and an intermediary tray component (fig. 1 illustrates that the intermediary component comprises a neck component or protrusion).
Regarding claim 5, Sikora in view of Reed discloses the invention as claimed as discussed above with respect to claim 1. Sikora further discloses that Discloses that the joint replacement implant is configured to receive at least one of: a pin; a fastener; and a keel, wherein the pin, the fastener, and the keel are configured to stabilize the joint replacement implant relative to a bone of the patient (¶0045 discloses that the joint replacement implant 92 receives a fastener/driver into its receptable 98 to drive the implant/shaft 92 into the bone of a patient).
Regarding claim 6, Sikora in view of Reed discloses the invention as claimed as discussed above with respect to claim 1. Sikora discloses that the shaft of the joint replacement implant is shaped and/or capable of being at least partially received within an intramedullary canal of a bone of the patient given the joint replacement implant’s (92) helical threads may comprises ribs, protrusions, barbs, or the like in order to threadably engage and connect with the bone (¶ 0044).
Regarding claim 7, Sikora in view of Reed discloses the invention as claimed as discussed above with respect to claim 1. Sikora further discloses that the shaft comprises a tapered shaft portion; and the helical thread comprises a tapered helical thread disposed about the tapered shaft portion (see fig. 1 below).
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Regarding claim 8, Sikora discloses a joint replacement implant system (Abstract) comprising: a joint replacement implant (¶0005; 92) comprising: a shaft comprising: a proximal end; a distal end; and a threaded shaft portion (see fig. 1 above); and a helical thread disposed about the shaft defining a length of the threaded shaft portion (fig. 1 above illustrates a helical thread disposed about the shaft defining a length of the threaded shaft portion); and an articular member coupled to the proximal end of the joint replacement implant (fig. 3 illustrates an articular member 22 coupled to the proximal end of the joint replacement implant 92); wherein: the articular member comprises at least one artificial articular surface (fig. 1; 26); and the at least one artificial articular surface is shaped to replace at least a portion of a natural articular surface of a joint of a patient (¶0034 discloses that an artificial surface 26 is shaped to replace a portion of a natural articular surface of a joint of a patient e.g. glenoid surface).
Reed also discloses a shaft (13) comprising: a proximal end (2); a distal end (4); and a threaded shaft portion (12); a helical thread disposed about the shaft defining a length of the threaded shaft portion (see fig. 1). Reed teaches that a helical thread comprises a concave undercut surface angled towards one of the proximal end and the distal end of the shaft (fig. 9 illustrates a helical thread 12 comprising a concave undercut surface angled towards a proximal end of the shaft).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the joint replacement implant of Sikora to include that the helical thread comprises a concave undercut surface angled towards one of the proximal ends and the distal end of the shaft, as taught by Reed, in order to have a thread that allows maximum grip of bone and minimizes trauma in comparison to a common thread (Reed col.7 lines 13-16; also see fig. 9).
Regarding claim 9, Sikora in view of Reed discloses the invention as claimed as discussed above with respect to claim 8. Sikora further discloses that the joint replacement implant further comprises an attachment feature at the proximal end of the joint replacement implant configured to couple the articular member to the joint replacement implant (fig. 1 and fig. 3 illustrate that a joint replacement implant 92 comprises an attachment feature 62 coupled to the proximal end 97 of the joint replacement implant and configured to couple the articular member 22).
Regarding claim 10, Sikora in view of Reed discloses the invention as claimed as discussed above with respect to claim 9. Sikora further discloses that the joint replacement implant further comprises an intermediary component couplably disposed intermediate the attachment feature and the articular member and configured to couple therebetween (fig.1 illustrates an intermediary component 42 couplably disposed intermediate the attachment feature 62 and the articular member 22).
Regarding claim 11, Sikora in view of Reed discloses the invention as claimed as discussed above with respect to claim 8. Sikora further discloses that the joint replacement implant system further comprises at least one of: a pin; a fastener; and a keel, wherein the pin, the fastener, and the keel are configured to stabilize the joint replacement implant relative to a bone of the patient (¶0045 discloses that the joint replacement implant 92 receives a fastener/driver into its receptable 98 to drive the implant/shaft 92 into the bone of a patient).
Regarding claim 13, Sikora in view of Reed discloses the invention as claimed as discussed above with respect to claim 8. Sikora further discloses that the articular member comprises a tibial insert prosthesis (¶0026 discloses that the implant assembly 20 can be used to repair and/or replace any joint in the body); and the artificial articular surface comprises one or more concave artificial articular surfaces (¶0034 discloses and fig. 1 illustrates an articular surface 26 with a concave surface).
Regarding claim 15, Sikora discloses a method for replacing at least a portion of a natural articular surface of a joint of a patient comprising (¶ 0026/0036 disclose an implant assembly for repairing and/or replacing a joint in the body): preparing a bone of the patient to receive a joint replacement implant therein (¶ 0036 discloses preparing/forming an excision site in an articular surface of a patient’s bone); and inserting the joint replacement implant into the bone of the patient (¶ 0043 discloses inserting/securing a joint replacement implant 92 into a patient’s bone); wherein: the joint replacement implant (92) comprises: a shaft comprising: a proximal end; a distal end; and a threaded shaft portion (see fig. 1 above); a helical thread disposed about the shaft defining a length of the threaded shaft portion (fig. 1 above illustrates a helical thread disposed about the shaft defining a length of the threaded shaft portion), and an attachment feature at the proximal end of the joint replacement implant (fig. 1 and fig. 3 illustrate an attachment feature 62); wherein: the attachment feature is configured to couple an articular member to the joint replacement implant (fig. 3 illustrates that an attachment feature 62 couples an articular member 22 to the joint replacement implant 92); the articular member comprises at least one artificial articular surface (fig. 1; 26); and the at least one artificial articular surface is shaped to replace at least a portion of the natural articular surface of the joint of the patient (¶0034 discloses that an artificial surface 26 is shaped to replace a portion of a natural articular surface of a joint of a patient e.g. glenoid surface).
Sikora fails to discloses that the helical thread comprises a concave undercut surface angled towards one of the proximal ends and the distal end of the shaft.
Reed also discloses a shaft (13) comprising: a proximal end (2); a distal end (4); and a threaded shaft portion (12); a helical thread disposed about the shaft defining a length of the threaded shaft portion (see fig. 1). Reed teaches that a helical thread comprises a concave undercut surface angled towards one of the proximal end and the distal end of the shaft (fig. 9 illustrates a helical thread 12 comprising a concave undercut surface angled towards a proximal end of the shaft).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the joint replacement implant of Sikora to include that the helical thread comprises a concave undercut surface angled towards one of the proximal ends and the distal end of the shaft, as taught by Reed, in order to have a thread that allows maximum grip of bone and minimizes trauma in comparison to a common thread (Reed col.7 lines 13-16; also see fig. 9).
Regarding claim 16, Sikora in view of Reed discloses the invention as claimed as discussed above with respect to claim 15. Sikora in view of Reed discloses preparing the bone of a patient to receive the joint replacement implant therein as discussed in claim 15. Sikora further discloses that preparing the bone to receive the joint replacement implant further comprises: forming a bone tunnel in the bone configured to receive at least a portion of the joint replacement implant therein (¶ 0048 discloses drilling holes into the bone, i.e. bone tunnels, to receive the joint replacement implant 92).
Regarding claim 19, Sikora in view of Reed discloses the invention as claimed as discussed above with respect to claim 16. Sikora further discloses that inserting the joint replacement implant into the bone further comprises: placing the helical thread of the joint replacement implant adjacent the bone tunnel; and rotating the joint replacement implant relative to the bone tunnel to: form a helical bone thread about the bone tunnel via one or more self-tapping features of the joint replacement implant; and insert the joint replacement implant into the bone tunnel (¶ 0048 discloses drilling holes into the bone to receive the joint replacement implant 92 and then inserting the joint replacement implant into the hole and rotating it to engage and connect with the bone and ¶ 0044 discloses that the joint replacement implant 92 comprises helical threads that secure/threadably engage the implant to the bone i.e. a self-tapping feature).
Regarding claim 20, Sikora in view of Reed discloses the invention as claimed as discussed above with respect to claim 15. Sikora discloses coupling the articular member to the attachment feature of the joint replacement implant (¶ 0043 discloses and fig. 3 illustrates coupling an articular member 20 to the attachment feature 62 of the joint replacement implant 92).
Claims 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Sikora et al. (US 20150250602 A1) in view of Reed et al. (US 9079263 B2) as applied to claim 16 above, in further view of Assell (US 20090138053 A1).
Regarding claim 17, Sikora in view of Reed discloses the invention as claimed as discussed above with respect to claim 16. Sikora in view of Reed discloses preparing the bone of a patient to receive the joint replacement implant therein as discussed in claim 15. Sikora in view of Reed fails to disclose preparing the bone of a patient to receive the joint replacement implant therein further comprises tapping a helical bone thread about the bone tunnel formed in the bone.
Assell discloses analogous art pointing to a device/implant (40) for treating the joint of a patient (Abstract). Assell further discloses that the implant (40) comprises a shaft comprising: a proximal end; a distal end; and a threaded shaft portion; and a helical thread disposed about the shaft defining a length of the threaded shaft portion (see fig. 2 annotated below).
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Assell teaches tapping a helical bone thread about the bone tunnel formed in the bone (¶ 0097 discloses drilling a pilot hole/tunnel and tapping or pre-threading the pilot hole/tunnel, i.e. a helical bone thread, before inserting the implant 40 and ¶ 0098 discloses using a tap 130 comprising a helical thread as seen in fig. 8c). Both the invention of Sikora in view of Reed and the invention of Assell point to analogous devices/implants such as screws result in a screw (or shaft with a helical thread) implanted, embedded, fixated, or engaged within a bone to treat a joint (or may be configured to treat other articulating joints elsewhere in the body - Assell ¶ 0020).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method for replacing at least a portion of a natural articular surface of a joint of a patient of modified Sikora to include tapping a helical bone thread about the bone tunnel formed in the bone, as taught by Assell, as the modification merely involves a combination as the modification merely involves a combination of known methods of inserting a helical fastener into bone that achieves predictable results of anchoring an implant.
Regarding claim 18, Sikora in view of Reed and in further view of Assell discloses the invention as claimed as discussed above with respect to claim 17. Sikora in view of Reed discloses inserting the joint replacement implant into the bone of the patient as discussed in claim 15. Sikora in view of Reed fails to disclose that inserting the joint replacement implant into the bone of the patient further comprises: placing the helical thread of the joint replacement implant adjacent the helical bone thread tapped about the bone tunnel; and rotating the joint replacement implant relative to the bone tunnel to: insert the helical thread into the helical bone thread; and insert the joint replacement implant into the bone tunnel.
Assell teaches placing the helical thread of device/implant analogous to a joint replacement implant, as discussed in claim 17, adjacent the helical bone thread tapped about the bone tunnel; and rotating the joint replacement implant relative to the bone tunnel to: insert the helical thread into the helical bone thread; and insert the joint replacement implant into the bone tunnel (¶ 0108 discloses advancing/placing the implant 40 adjacent the helical bone thread about the bone tunnel/pre-tapped channel, that a tool/driver rotates/torques the implant 40 with the helical thread (fig. 2) causing it to engage with the pre-tapped channel/helical bone thread and inserting the implant into the bone tunnel (see fig. 3c)).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ADRIANA BAUTISTA whose telephone number is (571)272-0927. The examiner can normally be reached Monday-Friday 7:30am-5:00pm.
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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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/A.G.B./Examiner, Art Unit 3774
/SARAH W ALEMAN/Primary Examiner, Art Unit 3774
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