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 .
DETAILED ACTION
Status of Claims
This office action is responsive to the amendment filed on 08/05/2026. As directed by the amendment: claims 10-12 are withdrawn and claims 13-26 are presently pending in this application.
Response to Arguments
Applicant's arguments with respect to claims 13-26 have been considered but are moot in view of the new ground(s) of rejection.
Rejection under 35 USC 112 (b) of claim 19 has been withdrawn.
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.
Claim 13 recites the limitation "the body”. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 14 it is unclear as to how the cortical bone of the talar dome is removed from the three-dimensional model of the talar dome. Claim 13 requires the talar surface of the talar dome is modified and then the images of the modified talar dome are used to create a three-dimensional model of the talar dome. It’s not clear how the cortical bone would be removed from a three-dimensional model of the modified talar dome.
Claims 15-26 are rejected as being dependent from rejected 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.
Claims 13, 15, 18, 20-21, 23-24 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Mahfouz (2016/0361071) in view of Schon et al. (2015/0051706) “Schon”.
Regarding claim 13, as best understood, Mahfouz discloses a method of forming a talar component 86 (Fig. 7) of an ankle replacement system comprising steps of: obtaining image data of talar dome 27 (par. 0045-0046 disclose obtaining X-ray, CT and MRI imaging); using the obtained image data to create a three-dimensional model of the talar dome (par. 0046 discloses Talus 3D models can be created from multiple modalities including CT, MRI, X-ray, ultrasound modalities); and forming a body 86 having a talar surface (bottom surface having posts 92A/B; Fig. 7) that if configured to exactly fit with a portion of the surface of the three-dimensional model of the talar dome (par. 0060 discloses the talus model 27 can be used to produce patient specific instruments which includes implants, par. 0061 discloses a surgical planner involving manipulating component/implant positioning on the model and par. 0062 discloses choosing the implant size based on surgical planner where the implant size depends on the patient specific talus model interface fully capable of performing this intended use of being configured to exactly fit with a portion of the surface of the three-dimensional model of the talar dome); except for modifying a portion of the talar surface of the talar dome to compensate for injury to or disease of the talus prior to forming the body and obtaining image data of the modified talar dome.
However, Schon teaches a similar method of forming a talar component comprising the steps of modifying a portion of the talar surface of the talar dome to compensate for injury to or disease of the talus prior to forming the body (method claim 18 discloses resecting the talar bone and then fabricating a prosthesis to match the resected shape) and obtaining image data of the modified talar dome (the combination of the resection of Schon and the imaging of Mahfouz arrives at the imaging of the modified or resected bone).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify the method in Mahfouz to include a steps of: modifying a portion of the talar surface of the talar dome to compensate for injury to or disease of the talus prior to forming the body and obtaining image data of the modified talar dome, as taught and suggested by Schon, for providing a minimally resected talar surface prepared to receive a prosthesis (claim 18).
Regarding claim 15, Mahfouz discloses further comprising a step of: altering the image data to compensate for injury or disease on the surface of the talar dome prior to using the image data to create the three-dimensional model of the talar dome (par. 0044 discloses creating 3D segmentation from 700 talus bones include bone images capturing osteophyte growth in the images of the talus and adding osteophyte areas to bone models which includes the talar dome).
Regarding claim 18, Mahfouz discloses as step of forming at least one protrusion (92A/92B; Fig. 7) on a portion of the talar surface of the body 86 (Fig. 7).
Regarding claim 20, Mahfouz discloses wherein the talar component for use in an ankle replacement system comprises: a body 86 including: a talar surface having a portion contoured to approximately or exactly fit with a surface portion of a three-dimensional rendering of bone of a talar dome (par. 0060 discloses the 3D talus model 27 can be used to produce patient specific instruments which includes implants, par. 0061 discloses a surgical planner involving manipulating component/implant positioning on the model and par. 0062 discloses choosing the implant size based on surgical planner where the implant size depends on the patient specific talus model interface); and a tibial surface (surface that engages bearing 88; Fig. 7) configured for forming a joint with a second component 84 of the ankle replacement system (Fig. 7).
Regarding claim 21, Mahfouz discloses wherein the three-dimensional rendering includes cortical bone of the talar dome (talus model 27 includes 3D segmentation of the talus which includes cortical bone (par. 0044-0045).
Regarding claims 23-24, Mahfouz discloses wherein the portion of the talar surface approximately or exactly fits with a resected surface portion of the corresponding surface portion of the bone of the talar dome 25 and wherein the talar surface further comprises at least one protrusion 92A/B shaped to fit a resected portion of bone of the talar dome 25 (par. 0065 discloses talar surface having posts 92A-92B is for implanting into talus 25).
Regarding claim 26, Mahfouz discloses wherein the portion of the talar surface approximately fits with the corresponding surface portion of the three dimensional rendering of the bone of the talar dome or approximately fits with the corresponding surface portion of the bone of the talar dome (par. 0065 discloses talar surface having posts 92A-92B is for implanting into talus 25).
Claims 16, 17, 19 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Mahfouz (2016/0361071) in view of Schon et al. (2015/0051706) “Schon further in view of Bojarski et al. (2011/0029093) “Bojarski”.
Mahfouz in view of Schon teaches the claimed invention of claims 13, 18 and 20; except for further comprising a step of: creating at least one recess in a surface of the three-dimensional model prior to forming the body; further comprising a step of: altering the image data to include the at least one recess prior to using the image data to create the three-dimensional model of the talar dome and wherein each said at least one protrusion aligns with at least said recess in the surface of the three-dimensional model; and wherein the portion of the talar surface exactly fits with the corresponding surface portion of the three dimensional rendering of the bone of the talar dome.
However, Bojarski teaches a similar invention directed to articular implants and surgical procedures derived from images of patients’ ankle joints (abstract and par. 0868 and Table 4 disclose ankle joints) comprising; a step of: creating at least one recess in a surface of the three-dimensional model prior to forming the body; further comprising a step of: altering the image data to include the at least one recess prior to using the image data to create the three-dimensional model of the talar dome (par. 0281-0282 discloses generating models after forming drill holes in the generated models); wherein the portion of the talar surface exactly fits with the corresponding surface portion of the three dimensional rendering of the bone of the talar dome (par. 0439 discloses virtually fitting designed implants to the generated virtual bone models). The combination of the protrusions 92A/B of Mahfouz and recesses in Bojarski would arrive at each said at least one protrusion aligns with at least said recess in the surface of the three-dimensional model.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify the method in Mahfouz in view of Schon to include a step of: creating at least one recess in a surface of the three-dimensional model prior to forming the body; further comprising a step of: altering the image data to include the at least one recess prior to using the image data to create the three-dimensional model of the talar dome and wherein each said at least one protrusion aligns with at least said recess in the surface of the three-dimensional model; and wherein the portion of the talar surface exactly fits with the corresponding surface portion of the three dimensional rendering of the bone of the talar dome, as taught and suggested by Bojarski, for providing implants having features that closely mimic individual patient specific anatomy (par. 0012 of Bojarski).
Claims 14 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Mahfouz (2016/0361071) in view of Schon et al. (2015/0051706) “Schon further in view of Hensley et al. (2013/0204384) “Hensley”.
As best understood, Mahfouz in view of Schon discloses the method of claim 13; except for modifying a portion of the talar surface of the three-dimensional model of the talar dome to compensate for injury to or disease of the talus prior to forming the body comprises removing cortical bone of the talar dome to expose bone of the talar dome to provide a modified talar dome and the three-dimensional rendering includes a portion of the cancellous bone of the talar dome that is exposed by resection of a portion of cortical bone of the talar dome. However, Hensley teaches a similar invention comprising modifying a portion of the talar surface of the three-dimensional model of the talar dome to compensate for injury to or disease of the talus prior to forming the body comprises removing cortical bone of the talar dome to expose bone of the talar dome to provide a modified talar dome (Fig. 5 discloses the outer sections of the bone which would comprise cortical bone [dense outer surface of a bone] are resected and par. 0031 further discloses that cortical bone is only mirrored as a “possibility” and is only involved in “some edge locations” which implies the removal of cortical bone except around the edge locations; par. 0029 discloses resection planes 74/76/78/80/82 of cancellous bone) and a three-dimensional rendering of cancellous bone of the talar dome (par. 0026 discloses ankle joint and par. 0031 discloses imaging of cancellous bone); wherein the three dimensional rendering includes a portion of cancellous bone of the talar dome that is exposed by resection of a portion of cortical bone of the talar dome (Fig. 5 discloses the outer sections of the bone which would comprise cortical bone [dense outer surface of a bone] are resected and par. 0031 further discloses that cortical bone is only mirrored as a “possibility” and is only involved in “some edge locations” which implies the removal of cortical bone except around the edge locations; par. 0029 discloses resection planes 74/76/78/80/82 of cancellous bone). Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify the talar component in Mahfouz in view of Schon to include modifying a portion of the talar surface of the three-dimensional model of the talar dome to compensate for injury to or disease of the talus prior to forming the body comprises removing cortical bone of the talar dome to expose bone of the talar dome to provide a modified talar dome and wherein the three dimensional rendering includes a portion of cancellous bone of the talar dome that is exposed by resection of a portion of cortical bone of the talar dome, as taught and suggested by Hensley, for providing custom implants that mirror the surface of patient’s porous bone structure (par. 0004 of Hensley).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YASHITA SHARMA whose telephone number is (571)270-5417. The examiner can normally be reached on 8am-5pm M-Th; 8am-4pm Fri. 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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/YASHITA SHARMA/
Primary Examiner, Art Unit 3774
