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 .
Election/Restrictions
Claims 24-38 remain withdrawn as being directed towards a non-elected invention.
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 21 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over US 20170079553 to Gliner in view of US 20170071691 to Crawford, in further view of US 20180296074 to Trulson.
Regarding Claim 21, Gliner teaches a surgical system comprising:
(a) a magnetic field radiation assembly configured to surround a head of a patient (assembly 24, Figure 2; the radiators 26 surround the head of the patient, par. 0034);
(b) a probe configured to be inserted into the head of the patient, wherein the probe includes an exterior and a distal end (probe 28, Figure 1 includes distal end 34 and implicitly includes an exterior);
(d) a first sensor (sensor 32, Figure 1) configured to provide signals indicative of a position and orientation of the distal end relative to the patient (par. 0035, tracking of the distal end is provided with respect to the patient while the probe is inserted into the nasal sinus); and
(e) a sensor holder (sensor holder 64, Figure 3A-3B) configured to selectively couple the first sensor with the probe (via setscrew 72), wherein the sensor holder includes a through hole sized and configured to receive the exterior of the probe (through hole 68 in Figure 3B), wherein the sensor holder is moveable along the exterior of the probe between first and second longitudinal positions (using set screw 72, the holder is adjusted along the probe 28, par. 0043).
However, Gliner does not teach a robotic system, wherein (c) a robot arm is selectively coupled with the probe and configured to manipulate the probe relative to the head of the patient. Instead, Gliner teaches a handheld probe manipulated by the surgeon relative to the head of the patient (probe 52, Figure 1).
Crawford teaches a robotic system, wherein a robot arm is selectively coupled with the probe (as shown in Figure 8, the probe 608 is removably slid into the guide tube holder 606 of the robot end effector 602; par. 0034) and configured to manipulate the probe relative to the patient (as shown in Figures 1-2, the robot is utilized to move the probe relative to the patient; par. 0035-0036). Crawford further teaches drawbacks of manual holding surgical tools, such as being tedious, time-consuming and largely dependent on user dexterity (par. 0003), while providing a robotic system helps to solve these problems.
As such, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to include a robot arm to hold and manipulate the probe of Gliner, as taught by Crawford to provide the predicted results of being less tedious, less time-consuming and less dependent on operator dexterity due to automating a previously manual process. Further, courts have held that broadly providing an automatic or mechanical means to replace a manual activity which accomplished the same result is not sufficient to distinguish over the prior art (In re Venner, 262 F.2d 91, 95, 120 USPQ 193, 194 (CCPA 1958).
While Gliner further teaches a processor configured to tracking the movement of the probe within the patient based on signals from the first sensor (processor 40, par. 0036-0037, par. 0035, tracking of the distal end is provided with respect to the patient while the probe is inserted into the nasal sinus), Gliner does not teach wherein the processor is configured to calculate the insertion path of the probe based on the tracked movement or calculate a reinsertion path for the probe based on the calculated insertion path.
Trulson teaches a robotic tracking system wherein a probe in inserted into a human body and tracked. Similar to Gliner, a processor is utilized to calculate the relative position of the probe with respect to the anatomy. A trajectory of insertion and reinsertion are implicitly determined as the tracking data is recorded and then utilized to match it to a reinsertion path (par. 0099, “targeting having the probe reinserted into a position that it had traversed before….whether the probe is on the same path”). Trulson teaches the benefit is to provide visual guidance and suggestions to aid the user to maintain the probe on the same reinsertion path (par. 0099).
As such, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide both insertion paths and reinsertion paths as in Trulson, in order to provide guidance and suggestions to the user to maintain the probe on the same reinsertion path.
Regarding Claim 23, Gliner further teaches wherein the sensor holder completely encapsulated the first sensor (as shown in Figures 3A-3B, the sensor 32 is completely encapsulated by holder 64, par. 0039).
Claims 22 is rejected under 35 U.S.C. 103 as being unpatentable over US 20170079553 to Gliner in view of US 20170071691 to Crawford and US 20180296074 to Trulson, as applied to Claim 21 above, in further view of US 5829444 to Ferre.
Regarding Claim 22, Gliner further teaches wherein the magnetic field radiation assembly includes a plurality of magnetic field radiators (26, Figure 2) configured to radiate alternating magnetic fields at respective frequencies into a region that includes the head of a patient (par. 0034), wherein the alternating magnetic fields are configured to induce signal in the first sensor (sensor 32 contains coils where the signal is induced by the alternative magnetic field, par. 0034).
Gliner does not teach a second sensor configured to attach to the patient and corresponding induction of signals by the magnetic field radiation assembly. However, Gliner teaches that tracking of the probe with sensor is done with respect to the patient based on the signals induced by the magnetic fields (par. 0034-0035) thereby implying that the patient position is being tracked with respect to the magnetic field frame of reference. However, Gliner does not state how the patient is being tracked.
Similarly to Gliner, Ferre teaches external magnetic field generators to track positions of an inserted medical probe via signals induced in a sensor attached to the probe (field generator 88, probe 16, Figure 10, col. 6, lines 37-51; probe 16 contains sensor 40, as shown in Figures 5-6 that picks up the magnetic field induced signal, col. 4, lines 48-65). Ferre further discloses a second sensor (patient reference sensor 92, Figure 10) configured to attach to the patient (as shown in Figure 10) and correspondingly receives induction of signals by the magnetic field generator in order to track the patient in the same frame of reference (col. 6, lines 37-51).
One of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to provide the second sensor of Ferre in the system of Gliner in order to track the patient in the same frame of reference, i.e. to track the position of the patient with respect to the field generator, so the medical instrument’s position with respect to the patient can be known.
Response to Arguments
Applicant’s arguments with respect to claim(s) 21-23 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. The newly added Trulson reference teaches the amended features in combination with Gliner and Crawford. Examiner notes that as claimed, the reinsertion path can be a mirror of the insertion path (as in Trulson). However, in the disclosure, Applicant also teaches motion compensation on the reinsertion path.
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 ANGELA MARIE HOFFA whose telephone number is (571)270-7408. The examiner can normally be reached Monday - Friday 9:30 am - 6:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Keith Raymond can be reached at (571)270-1790. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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ANGELA M. HOFFA
Primary Examiner
Art Unit 3799
/Angela M Hoffa/Primary Examiner, Art Unit 3799
Prosecution Insights