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 § 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.
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.
Claim(s) 1-2 and 6-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Anderson (US 8182469 B2) in view of Lakin (7840256 B2).
Regarding claims 1 and 12, Anderson discloses an apparatus, comprising: a first clamp body (eg. Fig. 12, clamp body 400 with base 402) having: (i) a mounting surface configured to support the tracking array (eg. top surface of the clamp to grasp an accessory (eg. Fig. 15-17, top surface of drape portion 270a, Col. 14, Ln. 1-17); (ii) a first fastener (Eg. Fig. 12, lever portion 406, Fig. 19, first lever handle 604 and detent 606 and fixated parts on 608); and (iii) a first clamping surface (eg. Fig. 15-17, clamping surface shaped for the jaws to grasp in portion 270a, Col. 13, Ln. 50-57 clamp jaw 404); and a second clamp body having: (i) a second fastener complementary with the first fastener (Eg. other half of clamp jaw 404, eg. Fig. 12), the second fastener configured to engage with the first fastener to couple the first clamp body to the second clamp body (Eg. Fig. 19, second lever handle 604 and detent 606 and fixated parts on 608); (ii) a second clamping surface configured, when the second clamp body is coupled with the first clamp body, to define a clamping jaw for retaining an instrument (Eg. Fig. 17D-E, cannula 300) but does not disclose a tracking array having a plurality of fiducial markers.
Lakin teaches a fiducial marker tracker array (eg. Fig. 5A-D, markers 504, 506, 508 Col. 8 Ln. 39-57) on a mounting surface (eg. frame 502 with arm members 501a-c, Col. 8, Ln. 58 – Col. Col. 9, Ln. 5) and is attached to track a surgical instrument (eg. Fig. 5D, surgical instrument 640, Col. 9, Ln. 6-34).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the invention of Tierny to include Lakin’s tracking array with fiducial markers to enable real-time tracking of the clamped instrument’s position and orientation during image-guided surgery, enhancing accuracy and reducing the need for multiple specialized tools (eg. Col. 1, Ln. 40-55).
Regarding claim 2, the combined invention of Anderson and Lakin discloses the first fastener and the second fastener are configured to couple the first clamp body to the second clamp body to define the clamping jaw with variable size (eg. Anderson, Col. 12, Ln. 55 – Col. 13, Ln. 30, Col. 15, Ln. 20-67).
Regarding claim 6, the combined invention of Anderson and Lakin discloses the mounting surface is configured to receive the tracking array at a selected one of a plurality of predefined positions (eg. Lakin Fig. 5A-D, markers 504, 506, 508 Col. 8 Ln. 39- Col. 9, Ln. 34, markers movable around retainers 516a-f).
Regarding claim 7, the combined invention of Anderson and Lakin discloses the mounting surface includes a plurality of first guide structures arranged about an axis of the first clamp body; and wherein the tracking array includes a complementary guide structure configured to engage with one of the first guide structures and fix an angular position of the tracking array about the axis (eg. Lakin Fig. 5A-D, markers 504, 506, 508 Col. 8 Ln. 39- Col. 9, Ln. 54, markers movable around retainers 516a-f, Fig. 5-8).
Regarding claim 8, the combined invention of Anderson and Lakin discloses the guide structures include radial grooves; and wherein the complementary guide structure includes a ridge receivable within the radial grooves (eg. Lakin, Fig, 6, Col. 9, Ln. 15-54).
Regarding claim 9, the combined invention of Anderson and Lakin discloses a fastener to affix the tracking array to the first clamp body (eg. Lakin, Fig, 6, Col. 9, Ln. 5-54 attachment means readily known within the art).
Regarding claim 10, the combined invention of Anderson and Lakin discloses the fastener includes a bolt configured to extend through an aperture of the tracking array; and wherein the first clamp body includes a nut configured to receive the bolt (eg. Lakin, Fig, 6, Col. 9, Ln. 5-54 attachment means readily known within the art such as threading, one of ordinary skill would have been able to use screws and nuts as a fastener since screws and nuts are common in the art).
Regarding claim 11, the combined invention of Anderson and Lakin discloses at least one of the first clamp body and the second clamp body are manufacturing via injection molding or 3D printing (eg. Anderson, Col. 14, Ln. 1-16, HDPE or polyurethane which commonly uses injection molding to form parts).
Claim(s) 3-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Anderson (US 8182469 B2) in view of Lakin (7840256 B2), further in view Bales (US 5176702).
Regarding claim 3, the combined invention of Anderson and Lakin discloses the invention of claim 1, but does not disclose one of the first fastener and the second fastener includes a slot and a toothed tab; and wherein the other of the first fastener and the second fastener includes a serrated tongue receivable within the slot to engage with the toothed tab to prevent retraction of the tongue.
Bales teaches a handle with a slot (eg, 402 with toothed tab on a leaf spring 404, Col. 10, Ln. 59 – Col. 12, Ln. 43) with a ratchet mechanism with a lever arm with a barbed arm (Eg. 400).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the invention of Anderson and Lakin with the ratchet mechanism as taught by Bales to provide a commonly known secure, stepwise adjustable locking mechanism for variable clamping sizes, preventing unintended retraction, etc. while using Anderson’s clamp mechanism.
Regarding claim 4, the combined invention of Anderson, Lakin, and Bales discloses the toothed tab is deformable to release the tongue from the slot (Eg. Bales, Col. 7, Ln. 63 – Col. 8, Ln. 46, Col. 11, Ln. 24-51, claim 1, leaf spring 404 with toothed tab deforms via camming latch 408 to release the strip).
Regarding claim 5, the combined invention of Anderson, Lakin, and Bales discloses the first fastener includes the slot and the toothed tab; and wherein the second fastener includes the serrated tongue (eg Bales, Col. 11, Ln. 59 – Col. 12, Ln. 68, slot 402 and toothed tab on leaf spring 404 with the resilient strip 400).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL J LAU whose telephone number is (571)272-2317. The examiner can normally be reached 8-5:30 PM.
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/MICHAEL J LAU/Examiner, Art Unit 3796