DETAILED ACTION
Status of Claims
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-20 are pending.
Response to Arguments
Applicant makes three related arguments. Applicant argues that one of ordinary skill in the art would not modify the invention taught by Aljuri with the teachings of Lang because (1) Lang teaches other ways of tracking (not just using markers, (2) there is no objective reason to combine the references; and (3) Aljuri’s device is already stabilized using the balloon once inserted into the urethra. See Remarks at 6-9.
Applicant’s argument has been fully considered but it is not persuasive. Lang teaches that, as a matter of objective rationale, markers can be used to help the surgeon accurately place and position a device (emphases added):
[0934] In embodiments, one or more virtual medical devices, virtual implants, virtual implant components, virtual implant portions, virtual anchors, attachment or fixation members, and/or virtual instruments and/or virtual surgical tools can be moved, aligned, superimposed, projected or attached using one or more assistive tools. Such assistive tools can, for example, include handheld devices. The one or more assistive tools can be tracked using any of the tracking means described in the specification, including combinations thereof, including, but not limited to, optical markers, e.g. with one or more geometric patterns, and/or LED's, for example tracked using an image and/or video capture system or camera system integrated into, attached to or separate from an OHMD, navigation markers, e.g. infrared or RF marker's, e.g. tracked with a navigation system, IMU's, calibration phantoms, and/or reference phantoms. The one or more assistive tools can also be tracked using intrinsic tracking methods. The one or more assistive tools can also be directly recognized by one or more image capture systems or video systems and/or 3D scanners integrated into, attached to or separate from an OHMD, wherein the direct recognition and tracking allows to track the one or more assistive tools in one or more coordinate systems, e.g. a common coordinate system. In embodiments, a handheld device can have a wand, baton, stick, dowel like shape, which can be tracked directly, e.g. using one or more image capture or video capture systems and/or 3D scanners, or optionally with one or more optical markers, LED's, navigation markers, IMU's, phantom's and the like attached to a first and, optionally, a second end. The surgeon can hold the wand, baton, stick or dowel like handheld device, for example, between a thumb and an index or other finger. The surgeon can execute commands, e.g. a virtual command or a voice command, to activate direct tracking or tracking of the wand, baton, stick or dowel like handheld device or to stop tracking of the wand, baton, stick or dowel like handheld device. One or more assistive tools can also be attached to the surgeon, e.g. the surgeon's wrist or arm. As the surgeon moves the wrist or arm, the position, orientation, alignment, direction of movement and/or speed of movement can be tracked. As the system tracks the position and/or orientation, and/or alignment and/or direction of movement and/or speed of movement, e.g. in a common coordinate system or any coordinate system, the position and/or orientation, and/or alignment and/or direction of movement and/or speed of movement can be translated into a corresponding position and/or orientation, and/or alignment and/or direction of movement and/or speed of movement or corresponding change in position and/or orientation, and/or alignment and/or direction of movement and/or speed of movement of the one or more projected virtual medical device, virtual implant or implant component, virtual anchor, attachment or fixation member, and/or virtual instrument and/or virtual tool. Thus, in this example, by moving the handheld device or assistive tool the surgeon can effect a movement of the virtual medical device, virtual implant or implant component, virtual anchor, attachment or fixation member, and/or virtual instrument and/or virtual tool displayed by the OHMD and the surgeon can virtually position, orient, align, superimpose or project the virtual medical device, virtual implant or implant component, virtual anchor, attachment or fixation member, and/or virtual instrument onto the physical anatomy or pathology of the patient, the physical surgical site, a resected tissue, a resected bone or cartilage, a hidden tissue, an area deep inside the tissue, e.g. inside a bone, a physical medical device present in the tissues of the patient and/or any surrounding, adjacent or subjacent tissues. As the surgeon moves the one or more assistive tools and the position, orientation, alignment, direction and/or speed of movement is tracked, the corresponding change in position, orientation, alignment, direction and/or speed of movement and/or coordinates of the virtual medical device, virtual implant, virtual implant component, virtual anchor, attachment or fixation member, and/or virtual instrument can be the same or can be less or more. For example, changes in position, orientation, alignment, direction and/or speed of movement and/or coordinates of the assistive tool can optionally be translated into corresponding changes in the position, orientation, alignment, direction and/or speed of movement and/or coordinates of the virtual device, virtual implant, virtual implant component, virtual anchor, attachment or fixation member, virtual instrument or virtual surgical tool with a 1.5:1, 2:1, 3:1, 4:1, 5:1 or any other ratio. In this example, the movement of the virtual device, virtual implant, virtual implant component, virtual anchor, attachment or fixation member, virtual instrument and/or virtual surgical tool is smaller than the movement of the assistive tool, which can help the surgeon placing the virtual device, virtual implant, virtual implant component, virtual instrument and/or virtual surgical tool with high accuracy over an intended area, e.g. an implantation site. In another example, changes in position, orientation, alignment, direction and/or speed of movement and/or coordinates of the assistive tool can optionally be translated into corresponding changes in the position, orientation, alignment, direction and/or speed of movement and/or coordinates of the virtual device, virtual implant, virtual implant component, virtual anchor, attachment or fixation member, virtual instrument or virtual surgical tool with a 1:1.5, 1:2, 1:3, 1:4, 1:5 or any other ratio. In this example, the movement of the virtual device, virtual implant, virtual implant component, virtual anchor, attachment or fixation member, virtual instrument and/or virtual surgical tool is larger than the movement of the assistive tool, which can help the surgeon placing the virtual device, virtual implant, virtual implant component, virtual instrument and/or virtual surgical tool with high speed over an intended area, e.g. an implantation site. The surgeon or an operator can optionally change these ratios. Non-linear ratios can be applied. For example, at the beginning of a virtual placement or alignment or fitting or selection, the movement of the virtual device, virtual implant, virtual implant component, virtual anchor, attachment or fixation member, virtual instrument or virtual surgical tool can intentionally be larger than the movement of the assistive tool in order to facilitate quick and time efficient placement, alignment and/or evaluation or any of the foregoing steps, including the ones tabulated in Table 15. As the procedure progresses, the movement of the virtual device, virtual implant, virtual implant component, virtual anchor, attachment or fixation member, virtual instrument or virtual surgical tool can intentionally be smaller than the movement of the assistive tool in order to facilitate accurate and reproducible placement, alignment and/or evaluation or any of the foregoing steps, including the ones tabulated in Table 15.
Note that Aljuri is silent on this initial step of positioning and placing the surgical device. Importantly, Aljuri’s disclosure relates to stabilizing the device after it has been positioned. Specifically, Aljuri discloses that “[o]nce the catheter 10 has been positioned so that the anchoring balloon 24 is located just distal of the bladder neck BN (FIG. 3B) the balloon can be inflated, preferably to occupy substantially the entire interior of the bladder, as shown in FIG. 3C. Once the anchoring balloon 24 is inflated, the position of the prostatic tissue debulking device 10 will be fixed and stabilized within the urethra U so that the energy source 20 is positioned within the prostate P.” See [0040].
Lastly, even though Lang discloses a few alternative solutions, it would be obvious to try Lang’s teaching of using markers. See MPEP 2143 (“Examples of rationales that may support a conclusion of obviousness include . . . (E) "Obvious to try" – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success . . .”).
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.
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.
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, 5-7, 10, 13, 15, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Aljuri et al. (US 20090227998 A1, 2009-09-10) (hereinafter “Aljuri”) in view of Lang (US 20200138518 A1, 2020-05-07).
Regarding claims 1, 5-7, 10, 13, 15, and 19-20, as discussed above (Response to Arguments incorporated by reference herein), Aljuri teaches a robotically controlled laser bone resection device comprising: a handheld housing (e.g., comprising 60, 100) comprising: a treatment laser (e.g., [0018]; 22, Fig. 1) configured to generate a treatment laser beam, a laser scanner configured to direct the treatment laser beam (e.g., [0046]), a water nozzle configured to emit a laminar waterjet (e.g., “FS”), and an aperture (e.g., 34, 82) configured to emit the treatment laser beam within the laminar waterjet; (e.g., Figs. 2, 6; [0013], [0016], [0039])
Aljuri does not teach a tracking marker attached to the handheld housing. Lang teaches use of tracking markers for medical handheld devices. See, e.g., [0934].
Aljuri also does not teach the various optical parameters and sensor types recited in the claims. Lang teaches use of various wavelengths (e.g., [0253], [0387]), laser-based distance sensors (e.g., [0316]), ultrasound transducers (e.g., [0373]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the teachings of Lang with the invention taught by Aljuri such that the invention further comprises a tracking marker attached to the handheld housing (as recited in claim 1); further comprising a laser emitter within a visible spectrum configured to aid in targeting the treatment laser beam (e.g., [0253], [0387] of Lang) (as recited in claims 5 and 19); further comprising a laser emitter configured to measure a distance between the device and a target surface (e.g., [0316] of Lang) (as recited in claims 6 and 20); further comprising an ultrasound transducer configured to detect acoustic waves generated by optical excitation of a target (e.g., [0373] of Lang) (as recited in claim 7); a surgical laser resection system comprising: a handheld device (e.g., comprising 60, 100) comprising: a treatment laser (e.g., [0018]; 22, Fig. 1) configured to generate a treatment laser beam, a laser scanner configured to direct the treatment laser beam (e.g., [0046]), a water nozzle configured to emit a laminar waterjet (e.g., “FS”), an aperture configured to emit the treatment laser beam within the laminar waterjet t(e.g., 34, 82), and a tracking marker (e.g., [0934] of Lang); and a control unit (e.g., 214) configured to control the treatment laser and control water flow to the water nozzle; a tracking system configured to detect a position of the tracking marker (e.g., [0255] of Lang); a power generator (e.g., [0660] of Lang) electrically coupled to the treatment laser; and a cable harness interfacing the control unit and the power generator to the handheld device (Official Notice is given cable harnesses are well-known and widely-used in the art) (as recited in claim 13); further comprising a tip, wherein the treatment laser produces a resection larger than the tip such that the tip can enter the resection (e.g., construed as the capability of the device taught by Aljuri) (as recited in claim 10); further comprising an external control device configured to enable/disable the treatment laser (Official Notice is given switches and other external control devices are well-known and widely-used in the art) (as recited in claim 15) in order to improve the accuracy of the treatment.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Aljuri in view of Lang, as applied to claim 1, and further in view of Zabar et al. (US 20170079718 A1, 2017-03-23) (hereinafter “Zabar”).
Regarding claim 8, Aljuri (in view of Lang) teaches a robotically controlled laser bone resection device comprising, except comprising optical elements configured to shape the treatment laser beam into a top-hat beam.
Zabar teaches the advantages of using a top-hat beam in the surgical context. See, e.g., [0024] (“Such a laser a priori outputs a beam with low spatial coherence, and therefore reduces the prevalence to damage in the bulk of the fiber due to interference phenomena. Such a laser outputs a beam which is significantly closer to having a uniform beam profile, known as a top-hat configuration, than the prior art, high quality lasers generally used in such systems. In order to improve the immunity from fiber damage even more, prior art homogenization, beam manipulation methods can also advantageously be applied to such a flat-topped beam, with accordingly improved performance.”).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the teachings of Zabar with the invention taught by Aljuri (in view of Lang) such that the invention further comprises optical elements configured to shape the treatment laser beam into a top-hat beam in order to improve the reliability of the device.
Claims 9 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Aljuri in view of Lang, as applied to claim 1, and further in view of Assa et al. (US 20090186318 A1, 2009-07-23) (hereinafter “Assa”).
Regarding claims 9 and 12, Aljuri (in view of Lang) teaches a robotically controlled laser bone resection device comprising, except comprising an erbium yttrium-aluminum-garnet laser and an extraction system comprising a pressurized microcavity running parallel to the treatment laser beam.
Assa teaches use of erbium yttrium-aluminum-garnet lasers to generate cavitation effects for ablation. See, e.g., [0016].
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the teachings of Assa with the invention taught by Aljuri (in view of Lang) such that the invention further comprises the treatment laser is an erbium yttrium-aluminum-garnet laser (e.g., [0016] of Assa) (as recited in claim 9); further comprising an extraction system comprising a pressurized microcavity running parallel to the treatment laser beam (e.g., [0016] of Assa) (as recited in claim 12) to improve the efficacy of the device.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Aljuri in view of Lang, as applied to claim 1, and further in view of Lang (US 20150223941 A1, 2015-08-13) (hereinafter Lang ‘941).
Regarding claim 11, Aljuri (in view of Lang) teaches a robotically controlled laser bone resection device comprising, except wherein the tip is configured to be removeable and disposable.
Lang ‘941 teaches the advantages of using disposable instruments and components in the surgical context. See, e.g., [0056] (“Various embodiments described herein further include the use of patient-specific anatomical data in design and/or selecting of surgical instruments and guide tools for preparing a patient's glenoid and humerus, with the glenoid instrument and companion humeral instruments (e.g., instruments and guide tools) generated and provided to guide and accomplish the resection of bone in preparation for the implantation of the various components of the total shoulder implant system. The various humeral and glenoid instruments can be defined and manufactured from any biocompatible material, including, sterilizable plastic, polymers, ceramics, metals or combinations thereof, using various manufacturing processes. The tools can be disposable and can be combined or used with reusable and non patient-specific cutting and guiding components. The instruments will desirably be steam sterilizable and biocompatible.”).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the teachings of Lang ‘941 with the invention taught by Aljuri (in view of Lang) such that the invention further comprises wherein the tip is configured to be removeable and disposable in order to improve the sterility of the surgical treatment.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Aljuri in view of Lang, as applied to claim 1, and further in view of McFarlin et al. (US 20070100336 A1, 2007-05-03) (hereinafter “McFarlin”).
Regarding claim 16, Aljuri (in view of Lang) teaches a robotically controlled laser bone resection device comprising, except wherein the control unit is configured to automatically disable the treatment laser based on achieving a predetermined resection depth. McFarlin teaches automatic disabling of resection for purposes of safety. See, e.g., [01016]. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the teachings of Lang ‘941with the invention taught by Aljuri (in view of Lang) such that the invention further comprises wherein the control unit is configured to automatically disable the treatment laser based on achieving a predetermined resection depth in order to improve the safety of the surgical treatment.
Allowable Subject Matter
Claim 2-4, 14, and 17-18 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 prior art of record does not teach or suggest the claimed invention of the device of claim 1, further comprising: a handle; and a gross positioning actuator; wherein the gross positioning actuator provides two degrees of freedom of movement between the handle and the handheld housing (as recited in claims 2 and 14); further comprising a fine positioning actuator configured to position the laser scanner (as recited in claims 3 and 17).
For these reasons the claims are believed to be allowable over the art of record.
Conclusion
THIS ACTION IS MADE FINAL. 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SCOTT T LUAN whose telephone number is (571)270-1860. The examiner can normally be reached on 9am-5pm, M-F (generally).
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Gary Jackson, can be reached on 571-272-4697. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Scott Luan
/SCOTT LUAN/Primary Examiner, Art Unit 3792
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