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 Interpretation
The term “sensor” in the claims is interpreted as reading on either a sensor or a tracker, consistent with instant claim 17, which recites that “the first system
reference sensor” comprises a “tracker”.
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 1 - 19 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.
Where applicant acts as his or her own lexicographer to specifically define a term of a claim contrary to its ordinary meaning, the written description must clearly redefine the claim term and set forth the uncommon definition so as to put one reasonably skilled in the art on notice that the applicant intended to so redefine that claim term. Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999). The term “channel” in claim 1 is used by the claim to mean a “groove, notch, or corrugation” (see [0087] - [0089] of the published specification and elements 420A - 420D in figs. 4A - 4B) while the accepted meaning is “a path, pipe, or route where things like water, data, or messages travel.” The term is indefinite because the specification does not clearly redefine the term. Those of ordinary skill in the art would not recognize the disclosed elements 420A - 420D in figs. 4A - 4B as “channels”.
Claims 2 - 19 are indefinite by virtue of dependency.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 3 - 4, 6 - 8, 12 - 14, and 16 - 19 are rejected under 35 U.S.C. 103 as being unpatentable over DiMaio et al. (US 2016/0206384, of record) in view of Onoda et al. (US 2011/0098533, of record), Baur et al. (US 2007/0118140, of record), Mao et al. (“Comparison of the cable pin system with conventional open surgery for transverse patella fractures.” Clin Orthop Relat Res. 2013 Jul;471(7):2361-6, of record), and Rogers et al. (US 2008/0287963).
Regarding claim 1, DiMaio shows a surgical navigation system (sensor system 10, [0030] and fig. 1) comprising:
a multi-core fiber optic cable (“multi-core optical fiber”, [0034] and fig. 2-3), comprising:
a plurality of optical fibers (“multiple optical cores, 52, 54, 56, 58, 60, 62, 64 within a cladding 66”, [0034] and fig. 2-3), a coupler (“sensor devices … coupled … to the interrogation system 12”, [0031] and fig. 1) to optically couple the optical fibers to an optical generator,
a plurality of fiber Bragg gratings (FBGs), where one of the FBGs is in each of the optical fibers, (FBGs within each core, [0035] - [0037]),
a tracking sensor portion comprising one of the FBGs and arranged to be affixed to an anatomy of a patient ([0035] - [0037] and fig. 4 - the “one of the FBGs” is mapped to any relatively distal FBG in either sensor device 16 or 18, and a portion of the device in direct contact therewith is interpreted as the “tracking sensor portion”),
a reference sensor portion comprising a second of the FBGs ([0035] - [0036] - the ‘second FBGs’ is mapped to any FBG adjacent the relatively distal FBG in the core comprising the “one of the FBGs”. The portion of the device in direct contact with the second FBG is interpreted as the “reference sensor portion”), and
a cable shroud (cladding 66, [0034] and fig. 2-3) enclosing the plurality of optical fibers;
an optical signal generator and receiver (“interrogator 12 generates and receives the returned light for each core”, [0037]) coupled to the optical fibers, and configured to transmit an optical excitation signal to the optical fibers and receive an optical reflection signals from the optical fibers, wherein the optical reflection signals are generated by the FBGs (implicit); and
a computing system (“control system 27 … processors … instructions…”, [0039] and fig. 1) comprising processing circuitry and memory comprising instructions configured to cause the processing circuitry to:
receive an indication of the optical excitation signal and the plurality of optical reflection signals (“… 556, the sensor device 16 is interrogated to determine the shape of the of the sensor device…”, [0041] and fig. 5),
identify a tracking information of the tracking sensor portion based on optical reflection signals of the FBG in the tracking sensor portion relative to optical reflection signals of the second of the plurality of FBGs (“… FBG's … determine the amount of bending … known spacings of the FBG regions … used to reconstruct the shape of the fiber… position and orientation of the distal ends 16b, 18b … or other axial portions of the sensor devices may be determined”, [0038]), and
determine a pose of the anatomy of the patient based in part on the optical excitation signal, the tracking information, and the optical reflection signals ([0038]; “measured shapes of the sensor devices are used to determine the position and orientation of the distal ends of each sensor device”, [0040]; “… 560, the relative locations of the target fixtures 32a, 32b, … tracked … the femur 40 and the tibia 42 are moved … attached target fixtures and sensor devices are also moved and the position of the target fixtures is tracked by the sensor devices 16, 18…”, [0043] and figs. 4 - 5).
Although DiMaio reconstructs the shape of the fibers and discusses determining the position and orientation of the distal ends or other axial portions of the sensor devices ([0038]), DiMaio doesn’t explicitly state that the tracking information that is used for the shape reconstruction and/or device pose determinations includes the position and orientation of the tracking sensor portion. In addition, DiMaio fails to show a first system reference sensor configured to be arranged on the anatomy of the patient and configured to provide an indication of a position of a surgical tool relative to cable pins configured to be attached to the anatomy of the patient. Further, DiMaio fails to show the cable shroud comprises a plurality of channels formed in an exterior surface thereof and located adjacent to one of the FBGs.
Onoda discloses medical shape sensing techniques. Onoda teaches tracking information that is used for shape reconstruction and/or device pose determinations, and includes the position and orientation of a tracking sensor portion (“three FBG sensor sections … calculates a center position … and an orientation … of the neighboring three FBG sensor sections … from the amount of deformation of the FBG sensor sections …”, [0098]; [0099] - [0102]).
Baur discloses orthopedic surgery techniques. Baur teaches a first system reference sensor arranged on the anatomy of the patient and configured to provide an indication of a position of a surgical tool relative to pins attached to the anatomy of the patient (“markers 116 are fixedly mounted on bones 105 (via … pins) … positioned within the field of view of the cameras … track the location and orientation of those bones and/or medical instruments”, [0007] and figs. 1 - 2; [0038] - [0039]).
Mao discloses surgical techniques. Mao teaches pins that are cable pins (title, abstract).
Rogers discloses minimally invasive surgery. Rogers teaches a cable shroud that comprises a plurality of channels formed in an exterior surface thereof ([0069]; “… high performance flexible plastic … periodically notched with a series of linear notches 409 near a plurality of steering points 410A-410N so that it may sufficiently flex to make turns as it is inserted into a body cavity… v-shaped grooves… corrugation …”, [0088] and fig. 4G) and located adjacent to an FBG (fiber optic shape sensors, [0125]).
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 invention of DiMaio to have the tracking information that is used for the shape reconstruction and/or device pose determinations include the position and orientation of the tracking sensor portion, as taught by Onoda, in order to ensure accurate reconstruction of the fiber optic cable pose, to thereby facilitate accurate tracking of within the surgical navigation reference frame, as is understood in the art.
It also 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 combined invention of DiMaio and Onoda to include a first system reference sensor configured to be arranged on the anatomy of the patient and configured to provide an indication of a position of a surgical tool relative to pins configured to be attached to the anatomy of the patient, as taught by Baur, in order to facilitate generating useful information to help the surgeon determine appropriate locations or alignments for prosthetic implants, cutting jigs, saws for cutting bones, and the like, as suggested by Baur ([0007]).
In addition, 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 combined invention of DiMaio, Onoda, and Baur to have the pins comprise cable pins, as taught by Mao, in order to lead to facilitate achieving desired outcomes in knee surgery, as discussed by Mau (“… less early postoperative pain, better mobility angles of the injured knee, higher functional score of the injured knee, and decreased incidence of complications”, Conclusions section of abstract).
Further, 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 combined invention of DiMaio, Onoda, Baur, and Mau to have the cable shroud comprises a plurality of channels formed in an exterior surface thereof and located adjacent to one of the FBGs, as taught by Rogers, in order to provide the shroud with structural characteristics to help control flexibility of the apparatus, as suggested by Rogers ([0088]), and is well-understood and conventional in the art.
Regarding claim 3, the combined invention of DiMaio, Onoda, Baur, Mao, and Rogers discloses the claimed inventions substantially as noted above. DiMaio further shows that the length of the tracking sensor portion is less than or equal to 2 meters, as the tracking sensor portion length is mapped to the length between two adjacent FBGs.
Regarding claim 4, the combined invention of DiMaio, Onoda, Baur, Mao, and Rogers discloses the claimed invention substantially as noted above. DiMaio further shows that the diameter of the sensor is less than or equal to 330 microns (“multi-core optical fiber has a diameter of approximately 200 μm”, [0034]).
Regarding claim 6, the combined invention of DiMaio, Onoda, Baur, Mao, and Rogers discloses the claimed inventions substantially as noted above. Further, in the combined invention of the prior art, the at least one tracking sensor portion comprises a plurality of tracking sensor portions, as each of the FBGs is tracked relative to the others.
Regarding claims 7 - 8, the combined invention of DiMaio, Onoda, Baur, Mao, and Rogers discloses the claimed inventions substantially as noted above. DiMaio further shows a surgical system reference sensor (reference fixture, [0032]; [0041] - [0043]), wherein the processing circuitry is configured to identify surgical system coordinates based on the surgical system reference sensor and translate the pose into the surgical system coordinates ([0041] - [0043]), wherein the surgical system coordinates are three-dimensional cartesian coordinates (“three-dimensional space (e.g., three degrees of translational freedom along Cartesian X, Y, Z coordinates)”, [0028]).
Regarding claim 12, the combined invention of DiMaio, Onoda, Baur, Mao, and Rogers discloses the claimed inventions substantially as noted above. Further, the system of Dimaio is at least physically capable of being used with anatomy of the patient that is a bone, and the tracking sensor portion is at least physically capable of being coupled to the patient via a bone screws or a bone pin (see [0055] and fig. 14), and therefore meets the claim.
Regarding claim 13, the combined invention of DiMaio, Onoda, Baur, Mao, and Rogers discloses the claimed inventions substantially as noted above. Further, the tracking sensor portion of Dimaio is at least physically capable of being coupled to the patient via cement, adhesive, or a clamp (see [0033], [0055], and fig. 14), and therefore meets the claim.
Regarding claim 14, the combined invention of DiMaio, Onoda, Baur, Mao, and Rogers discloses the claimed inventions substantially as noted above. DiMaio further shows that the multi-core fiber optic cable is disposed in an IM nail ([0054] and fig. 13).
Regarding claim 16, the combined invention of DiMaio, Onoda, Baur, Mao, and Rogers discloses the claimed inventions substantially as noted above. Further, in the combined invention of the prior art, the cable pins comprise at least a first cable pin attached to a first portion of the patient anatomy and at least a second cable pin attached to a second portion of the patient anatomy, the second portion spaced apart from the first portion, as these are implicit from the recitations of claim 1.
Regarding claims 17 - 18, the combined invention of DiMaio, Onoda, Baur, Mao, and Rogers discloses the claimed inventions substantially as noted above. Further, in the combined invention of the prior art, the first system reference sensor comprises an optical tracker/marker and is attached to the patient anatomy (Baur: “markers 116 are fixedly mounted on bones 105 (via … pins) … positioned within the field of view of the cameras … track the location and orientation of those bones and/or medical instruments”, [0007] and figs. 1 - 2; [0038] - [0039]).
Regarding claim 19, the combined invention of DiMaio, Onoda, Baur, Mao, and Rogers discloses the claimed inventions substantially as noted above. DiMaio further shows a second system reference sensor configured to be attached to the surgical tool to help the surgical navigation system determine the position of the surgical tool relative to the surgical space (“instrument 22 is moved to treat the patient leg, the target fixture 32c is moved and tracked by the sensor device 20. Thus, the relative location of the instrument with respect to the target fixtures on the femur and tibia may be tracked”, [0043]).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over DiMaio, Onoda, Baur, Mao, and Rogers as applied to claim 1 above, and further in view of De Montmorillon et al. (EP 2116877, of record).
Regarding claim 2, the combined invention of DiMaio, Onoda, Baur, Mao, and Rogers discloses the claimed inventions substantially as noted above.
DiMaio fails to show that the cable shroud comprises a flattened shape, wherein a cross-section of the cable shroud has a first dimension that is longer than a second dimension thereof, wherein the second dimension substantially orthogonal to the first dimension.
De Montmorillon discloses optical fibers. De Montmorillon teaches a cable shroud comprising a flattened shape, wherein a cross-section of the cable shroud has a first dimension that is longer than a second dimension thereof, wherein the second dimension substantially orthogonal to the first dimension (trapezoidal or flat cross-section, [0109]).
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 combined invention of DiMaio, Onoda, Baur, Mao, and Rogers to have the cable shroud comprise a flattened shape, wherein a cross-section of the cable shroud has a first dimension that is longer than a second dimension thereof, wherein the second dimension substantially orthogonal to the first dimension, as taught by De Montmorillon, in order to optimize the form factor, for example, to help prevent any undesired rolling of the fiber relative to the longitudinal axis. It is noted that such changes in shape and or/dimensions are considered routine matters in the art, and are notoriously well-understood and conventional. See MPEP 2144.04. IV.A - B.
Claims 9 - 10 are rejected under 35 U.S.C. 103 as being unpatentable over DiMaio, Onoda, Baur, Mao, and Rogers as applied to claim 1 above, and further in view of Flexman et al. (US 2017/0273746, of record).
Regarding claims 9 - 10, the combined invention of DiMaio, Onoda, Baur, Mao, and Rogers discloses the claimed inventions substantially as noted above. DiMaio further shows overlaying a computed tomography image (“…present images of the surgical site … computerized tomography …”, [0062]) with surgical navigation information ([0063]; superimposed, [0064]).
DiMaio is not specific to the overlayed surgical navigation information comprising the pose of the anatomy of the patient.
Flexman discloses optical shape sensing in orthopedics. Flexman teaches overlayed surgical navigation information comprising the pose of the anatomy of the patient ([0024]; “displaying the deformations of soft tissue and the relative position of bones overlaid on an anatomic map 136 (e.g., an anatomical image of volume 131) … display of the position(s) of the optical shape sensing devices 102 with respect to each other and the anatomic map 136 …”, [0046]).
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 combined invention of DiMaio, Onoda, Baur, Mao, and Rogers to have the overlayed surgical navigation information comprise the pose of the anatomy of the patient, as taught by Flexman, in order to improve visualization of the surgical field.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over DiMaio, Onoda, Baur, Mao, and Rogers as applied to claim 1 above, and further in view of Larkin et al. (US 2007/0156019, of record).
Regarding claim 11, the combined invention of DiMaio, Onoda, Baur, Mao, and Rogers discloses the claimed inventions substantially as noted above.
DiMaio fails to show fiber tips that are exposed.
Larkin discloses surgical procedures using shape sensing. Larkin teaches fiber tips that are exposed (distal end of the fiber is exposed, [0080]).
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 combined invention of DiMaio, Onoda, Baur, Mao, and Rogers to include fiber tips that are exposed as taught by De Larkin, in order to provide illumination from the fibers in applications for internal use, as suggested by Larkin ([0080]).
In the combined invention of the prior art, the exposed fiber tips are at least physically capable of being inserted into a canal of respective cortical pins, and therefore meet the claim.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over DiMaio, Onoda, Baur, Mao, and Rogers as applied to claim 1 above, and further in view of Manzke et al. (US 2014/0088377, of record).
Regarding claim 15, the combined invention of DiMaio, Onoda, Baur, Mao, and Rogers discloses the claimed inventions substantially as noted above.
DiMaio fails to show FBGs arranged in a grid to form an FBG mesh.
Manzke discloses optical shape sensing. Manzke teaches FBGs arranged in a grid to form an FBG mesh (abstract; [0046]).
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 combined invention of DiMaio, Onoda, Baur, and Mao to include FBGs arranged in a grid to form an FBG mesh, as taught by Manzke, in order to improve measurement of dynamic movement, as suggested by Manzke (abstract).
Allowable Subject Matter
Claim 5 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: Regarding claim 5, the prior art of record, either singly or in combination, fails to teach or reasonably suggest the surgical navigation system of claim 1, wherein the at least one tracking sensor portion comprises: an exposed fiber tip arranged to be inserted into a canal of a cortical pin; and a cortical pin coupler arranged to couple to the cortical pin and fix the exposed fiber tip a known distance in the canal.
Response to Arguments
Applicant’s arguments with respect to claim 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 AMELIE R DAVIS whose telephone number is (571)270-7240. The examiner can normally be reached Monday-Friday, 9:30 - 6:00 PST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Pascal Bui-Pho can be reached at (571)272-2714. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AMELIE R DAVIS/Primary Examiner, Art Unit 3798
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