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
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.
Claim(s) 21-38 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cheal et al. (US 2012/0323244; “Cheal”).
Claim 21, Cheal discloses a system (Fig. 1) for use in orthopedic surgery on a bone (abstract), the system comprising: a cut guide (Fig. 2; 52, 54) configured to be positioned adjacent the bone (Fig. 2; paragraph [0042]), the cut guide comprising a guide body (52, 54) configured to be coupled to the bone (Fig. 2; paragraph [0042]), the guide body having a bone-facing surface (Fig. 2; surface facing the bone) and a guide member (54) configured to guide a cutting tool along a planned planar cutting trajectory (Fig. 2; paragraph [0042]); wherein the cut guide includes two or more reconfigurable landing members (See Fig. A below showing a possibility of what could be considered the landing members, the screw coming off 52 towards the bone can still be considered a landing member as well) configured to securely and fixedly position the cut guide adjacent the bone (Fig. 2; paragraph [0042]), wherein the two or more reconfigurable landing members comprise a structure separate from the guide body and fixable with the guide body so as to couple the guide body adjacent the bone (Fig. 2; paragraphs [0042]-[0044]), wherein the two or more reconfigurable landing members are configured to removably couple to a landing site of the bone (Fig. A; note how the landing members are coupled to bone via the device; paragraph [0042]); a processing device (Fig. 1; 100) including cut guide positioning planning instructions stored therein to generate a cut guide positioning plan (paragraphs [0044]-[0072]), wherein the cut guide positioning plan is generated at least in part using a bone model (paragraphs [0044]-[0072]); a computer-controlled robotic arm (50) configured to assist an operator in positioning the cut guide adjacent the bone based on the cut guide positioning plan (paragraphs [0038]-[0045]); a communication interface (30) configured to display a real time perioperative target bone representation and the planned planar cutting trajectory of the bone (paragraphs [0051]-[0072]).
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Fig. A: Annotated Fig. 2 of Cheal to help show claim limitations.
Claim 22, Cheal discloses the system of claim 21, wherein the guide body is configured to provide a secure attachment of the cut guide to the bone during performance of at least one bone cut (Fig. 2; paragraph [0048]).
Claim 23, Cheal discloses the system of claim 21, wherein the bone model includes a data set representing a bone having an anatomical origin comparable to the bone to be altered by the system (paragraphs [0046]-[0048]).
Claim 24, Cheal discloses the system of claim 21, further comprising a coupling receptacle preparation tool (Fig. 2; paragraph [0042]; the saw prepares the bone for receiving the implant) configured to be operated manually by the operator to create a plurality of receptacles on the bone (Figs. 1-5; paragraphs [0042] and [0055]).
Claim 25, Cheal discloses the system of claim 24, wherein the cut guide is configured to conform to the bone (Fig. 2).
Claim 26, Cheal discloses the system of claim 21, wherein the processing device further includes a surgical planning module (paragraph [0038]) configured to generate a surgical plan for altering at least a portion of the bone when the cut guide is positioned adjacent the bone (paragraphs [0038], [0045], and [0047]).
Claim 27, Cheal discloses the system of claim 26, wherein the cutting tool is configured to be positioned within the guide member for resecting the bone based on the surgical plan (paragraphs [0042]; [0045], and [0047]).
Claim 28, Cheal discloses the system of claim 21, wherein the guide body is configured to be adjustably coupled to the bone using pins (Fig. 2; you could put a pin through the slot 54 if desired).
Claim 29, Cheal discloses the system of claim 21, wherein the bone model is one of a parametric model, a statistical model, or a statistical shape model (paragraphs [0046]-[0048]).
Claim 30, Cheal discloses the system of claim 21, wherein the bone model is generated using two-dimensional image data of the bone (paragraphs [0046]-[0048] and [0062]-[0069]).
Claim 31, Cheal discloses the system of claim 21, wherein the bone is a femur (abstract; paragraphs [0001]-[0003]).
Claim 32, Cheal discloses the system of claim 31, wherein the planned planar cutting trajectory corresponds to a distal femur cut in a total knee arthroplasty procedure (paragraphs [0001]-[0003]).
Claim 33, Cheal discloses the system of claim 21, wherein the bone is a tibia (paragraphs [0001]-[0003]).
Claim 34, Cheal discloses the system of claim 33, wherein the planned planar cutting trajectory corresponds to a proximal tibial cut in a total knee arthroplasty procedure (paragraphs [0001]-[0003]).
Claim 35, Cheal discloses the system of claim 21, wherein the cut guide positioning plan can be modified intraoperatively (Fig. 8; paragraphs [0050] and [0055]).
Claim 36, Cheal discloses a system (Fig. 1) for use in orthopedic surgery on a bone (abstract), the system comprising: a cut guide (Fig. 2; 52, 54) to be positioned adjacent the bone (Fig. 2; paragraph [0042]), the cut guide comprising a guide body (52, 54) configured to be coupled to the bone (Fig. 2; paragraph [0042]), the guide body having an exterior surface (Fig. 2; outer surface) and a guide member (54) configured to guide a cutting tool along a planned planar cutting trajectory (Fig. 2; paragraph [0042]); wherein the cut guide includes two or more reconfigurable landing members (See Fig. A above showing a possibility of what could be considered the landing members, the screw coming off 52 towards the bone can still be considered a landing member as well) configured to securely and fixedly position the cut guide adjacent the bone (Fig. 2; paragraph [0042]), wherein the two or more reconfigurable landing members comprise a structure separate from the guide body and fixable with the guide body so as to couple the guide body adjacent the bone (Fig. 2; paragraphs [0042]-[0044]), wherein the two or more reconfigurable landing members are configured to removably couple to a landing site of the bone (Fig. A; note how the landing members are coupled to bone via the device; paragraph [0042]); a processing device (Fig. 1; 100) including cut guide positioning planning instructions stored therein to generate a cut guide positioning plan (paragraphs [0044]-[0072]), wherein the cut guide positioning plan is generated at least in part using a bone model (paragraphs [0044]-[0072]); a communication interface (30) configured to display a real time perioperative target bone representation and the planned planar cutting trajectory of the bone (paragraphs [0051]-[0072]).
Claim 37, Cheal discloses the system of claim 36, further comprising a coupling receptacle preparation tool (Fig. 2; paragraph [0042]; the saw prepares the bone for receiving the implant) configured to be operated manually by the operator to create a plurality of receptacles on the bone (Figs. 1-5; paragraphs [0042] and [0055]).
Claim 38, Cheal discloses the system of claim 36, wherein the cut guide is configured to be adjustably positioned to conform to the bone (Figs. 2 and 8; paragraph [0043]).
Response to Arguments
In response to Applicant’s arguments that Cheal fails to disclose the landing members being couplable to the bone, the Examiner respectfully disagrees. The entire device 50 is said to be mountable to the bone (paragraph [0042]). Therefore, the two landing members as pointed out by Fig. A, which are part of device 50, are removably coupled to the bone.
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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Zade Coley whose telephone number is (571)270-1931. The examiner can normally be reached M-F (9-5) PT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Truong can be reached at (571)272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Zade Coley/Primary Examiner, Art Unit 3775
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