DETAILED ACTION
This is the first office action on the merits in this application. The claims of October 15, 2024, are under consideration. Claims 1-57 are pending.
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 .
Specification
The disclosure is objected to because of the following informalities: the term “joint pace” is used several times through the disclosure. Examiner presumes this to be a typographical error, and intend the term “joint space”.
Appropriate correction is required.
Claim Objections
Claims 3, 7, 12, 16, 20, 24 and 33 are objected to because of the following informalities: It appears that the term “joint pace” should read “joint space”. Appropriate correction is required.
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 32-52 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 32 requires a second series of cut paths. Claim 32 depends from claim 1 which does not provide antecedent basis for first paths. As such, it is unclear if claim 32 is requiring the first paths in addition to the second path. Examiner suggests re-naming the second path to a non-numerical name to obviate this rejection; or else changing dependence of this claim to depend from a claim which recites the first paths.
Claim 37 requires a third series of cut paths. Claim 37 depends from claim 1 which does not provide antecedent basis for first or second paths. As such, it is unclear if claim 37 is requiring the first and second paths in addition to the third path. Examiner suggests re-naming the second path to a non-numerical name to obviate this rejection; or else changing dependence of this claim to depend from a claim which recites the first and second paths.
Claim 41 requires a fourth series of cut paths. Claim 41 depends from claim 1 which does not provide antecedent basis for first, second or third paths. As such, it is unclear if claim 41 is requiring the first second and third paths in addition to the fourth path. Examiner suggests re-naming the fourth path to a non-numerical name to obviate this rejection; or else changing dependence of this claim to depend from a claim which recites the first, second and third paths.
Claim 45 requires a fifth series of cut paths. Claim 45 depends from claim 1 which does not provide antecedent basis for first, second, third or fourth paths. As such, it is unclear if claim 45 is requiring the first, second, third and fourth paths in addition to the fifth path. Examiner suggests re-naming the second path to a non-numerical name to obviate this rejection; or else changing dependence of this claim to depend from a claim which recites the first, second, third and fourth paths.
Claim 49 requires a sixth series of cut paths. Claim 49 depends from claim 1 which does not provide antecedent basis for first, second, third, fourth or fifth paths. As such, it is unclear if claim 49 is requiring the first, second, third, fourth and fifth paths in addition to the sixth path. Examiner suggests re-naming the second path to a non-numerical name to obviate this rejection; or else changing dependence of this claim to depend from a claim which recites the first, second, third, fourth and fifth paths.
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) 1, 53 and 57 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Abbasi et al. (US 2016/0206375 A1).
Regarding claims 1, 53, and 57, Abbasi teaches an active robotic system as at fig. 1, comprising:
an articulated arm 16 comprising a plurality of arm segments as seen at fig. 1 defining longitudinal axes, and adjustable joints coupled between adjacent arm segments that are configured to adjust the orientation of the axes of the adjacent arm segments;
a sagittal cutting blade 48 (see fig. 2) defining a cutting edge that is configured to cut while being oscillated along an oscillation pathway that extends on a plane defined by the blade; and
an end effector 18 coupled to an end arm segment of the plurality of arm segments and the sagittal cutting blade 48, the end effector comprising a powered drive portion that oscillates the sagittal cutting blade along the oscillation pathway,
wherein the robotic system of fig. 1 is configured to autonomously adjust the relative orientation of the arm segments of the articulated arm 16 while the sagittal cutting blade 48 oscillates along the cutting pathway to autonomously spatially translate the cutting edge of the sagittal cutting blade 48 along a plurality of optimized programmed cut paths 102, 104, 106, 108, 110, 112 ([0055], [0057], fig. 7, 8) to perform resections of portions of a proximal tibia and/or a distal femur of a patient via the sagittal cutting blade 48 to facilitate implantation of a femoral component and a tibial component, respectively, of a total knee arthroplasty prosthesis thereon. ([0052], e.g. fig. 8)
It is considered clear that memory discussed at [0035] must be utilized to store the cut paths.
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.
Claim(s) 2 and 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Abbasi in view of Bowling et al. (US 2016/0338782 A1).
Regarding claim 2, Abbasi teaches the limitations of claim 1, above, and the cut paths therein are considered a first series of cut paths.
However, Abbasi does not specify a plurality of optimized programmed cut paths comprise a first series of cut paths that are configured to create a tibial resection on the proximal tibia while preventing injury to the patient's patellar tendon, medial collateral ligament (MCL), lateral collateral ligament (LCL), and posterior cruciate ligament (PCL).
Bowling teaches cutting paths 70 for use in a patient’s knee (see e.g. fig. 3). The cutting paths include boundaries as discussed at [0082] to include constraints of the tool at certain tissues. The tool may be a saw blade [0066].
It would have been obvious to one with ordinary skill in the art at the time of the invention to modify the Abbasi teaching to include providing additional boundaries, or modifying the boundaries provided by Abbassi, in order to protect particular patient tissues, as suggested by Bowling. One would have done so in order to permit maintaining the native soft tissues while performing a knee surgery in order to simplify post-surgical healing.
Regarding claim 3, the first series of cut paths are configured to enter the joint space between the patient's proximal tibia and the distal femur as in Abbasi fig. 8 via an entry region on an anterior-medial bone region (see figs. 7 and 8).
The trajectories of the cut paths of the first series of cut paths extend in what appears to be a region between the patient's MCL and patellar tendon, though no explicit teaching of such is provided by Abbasi. In view of Bowling’s teaching to avoid soft tissues including ligaments, it would have been obvious to have the region shown in Abbasi fig. 7 include boundaries which would prevent interference with the MCL and patella tendon.
Claim(s) 4, 5, 54-56 is/are rejected under 35 U.S.C. 103 as being unpatentable over Abbasi in view of Bowling and Mittelstadt et al. (US 8,936,596 B2).
Regarding claims 4 and 54-56, the limitations of claim 3 were suggested by the combination, as above. However, the combination does not teach a first series of cut paths comprising a first counterclockwise anterior to posterior trajectory cut path that arcuately extends along a lateral bone boundary of the proximal tibia, and a second anterior to posterior clockwise trajectory cut path that arcuately extends along a medial bone boundary of the proximal tibia.
Mittelstadt suggests various cut paths in a bone (compare figs. 1C, 4, 5A, 5B and 11. Note that curved and arcuate cuts which read on what are claimed can be seen as at e.g. fig. 5B. Note that Mittelstadt teaches use of a saw blade with corresponding modifications to the cut paths (col. 9, lines 38-43). The cutting paths are considered to fall entirely within a particular boundary area. (e.g. cut patterns demonstrated at figs. 7A-9). In the fig. 11 version, then oriented as at fig. 5B, two cut paths with the claimed orientations would exist. Millstadt’s cut paths are taught being autonomously carried out. (col. 8, lines 15-22)
It would have been obvious to one with ordinary skill in the art at the time of the invention to carry out cuts in the claimed paths as suggested by Mittelstadt within boundary regions shown in the combination. One would have done so as a matter of causing a cutting tool to pass over all areas of bone within the boundary area.
Regarding claim 5, limiting the Mittelstadt counterclockwise and clockwise paths (suggested by fig. 5B and fig. 11) to only the “long” portions of the cut, and referring to the connecting lines between the long cuts as a third cut would result in the claimed cuts being made.
Allowable Subject Matter
Claims 6-56 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The claims cannot be allowed until such time as any rejections under 35 USC 112 are overcome.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to David Bates whose telephone number is (571)270-7034. The examiner can normally be reached Monday through Friday, 10AM-6PM
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/DAVID W BATES/Primary Examiner, Art Unit 3799