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 .
Response to Arguments
Applicant’s arguments with respect to claims 1-18 have been considered but are moot because the new ground of rejection does not rely on any combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-18 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Amended claim 1 recites “filter axial shift data…corresponding to linear translation”. Applicant mentions in the remarks that the support can be found in ¶0036, ¶0053 and Fig 3. However, none of the sections recites specifically any linear translation. “Positional change of the ablation probe along its trajectory e.g., along an axis of the ablation probe’s shaft”, as in ¶0053 (and throughout spec.) is broader in scope than axial shift along linear translation, and includes any data related to an axial shift. Examiner’s analysis of the specification does not find any data filtering specifically for this axial shift for linear translation only. Hence the originally filed specification does not support this limitation and claim is rejected as new matter. For examination purpose, examiner interprets as -----displacement data along the axis of the device---.
Claims 2-18 recite or encompass similar limitations and are rejected for same reasons as above.
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.
Claims 1-2, 7-8, 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Dalal [US 20140171792 A1] in view of Kallio [US 20050006986 A1].
As per claim 7, Dalal teaches a method for monitoring movement of an ablation probe during a microwave ablation procedure (Dalal Fig 1, ¶0041), the method comprising:
tracking position
in three-dimensional space (implied since the ablation system is in a 3d space),
the ablation probe defining a longitudinal axis (Dalal Fig 1 axis of probe 108, directional arrow 110);
determining axial shift data from the position
generating an alert based on the
The difference from claim is that Dalal does not teach tracking position
Kallio, in a related field of positioning/localization of an operating instruments, teaches, tracking position
Hence it is known from Kallio that displacement information could be determined from 3D space information, which includes information from other axes as well. Before the effective filing date of the claimed invention it would have been obvious to a person of ordinary skill in the art to modify the method in Dalal by using this method, so as to find deflections in the direction of y- and z-axes, in addition to axial displacements (Kallio ¶0026).
As per claim 8, Dalal in view of Kallio further teaches 8. (Original) The method of claim 7, wherein generating the alert includes generating at least one of an audible alert or a visual alert (Dalal Fig 1 step 312 display is visual alert).
As per claims 1-2, have limitations similar to claims 7-8 and are rejected for same reasons as above. Dalal in view of Kallio further teaches a system for performing a microwave ablation procedure (Dalal Fig 1, ¶0041),
the system comprising: an ablation probe configured to couple to an electrosurgical generator (Dalal ¶0002, ¶0021, ¶0027 a electrosurgical generator is implied for RF, heating, cooling or cryoablation) and
including an electromagnetic sensor (Dalal ¶0026 “The displacement tracking device 104 may include a signal emitter 102, such as … electromagnetic (EM) field generator”),
Claims 13-14 are directed to embody method of claims 7-8 in a “non-transitory computer-readable storage medium”. Before the effective filing date of the claimed invention it would have been obvious to a person of ordinary skill in the art to embody method of claims 7-8 in a “non-transitory computer readable storage medium” so that the instructions can be automatically executed.
Claims 3, 9, 15 rejected under 35 U.S.C. 103 as being unpatentable over Dalal in view of Kallio as applied to claims 1, 7, 13 above, and further in view of Webster [US 20070016067 A1] and further in view of Weng [US 5782766 A].
As per claims 3, 9, 15, Dalal in view of Kallio does not expressly teach determining a movement velocity of the linear translation of the ablation probe along the longitudinal axis based on the filtered axial shift data; and modulating the alert based on the determined movement velocity.
Webster, in a related field of guiding surgical needles teaches determining a movement velocity of the linear translation of the ablation probe along the longitudinal axis based on the filtered axial shift data (Webster ¶0021 “steering a needle having a bevel. The method comprises determining a desired position and orientation of the bevel; and computing a bevel translation speed”).
Before the effective filing date of the claimed invention it would have been obvious to a person of ordinary skill in the art to modify the method and system in Dalal in view of Kallio, by determining translation speed so as to steer without substantially without deflecting or distorting the tissue (Webster abstract).
Dalal in view of Kallio and Webster does not expressly teach modulating the alert based on the determined movement velocity.
Weng, in a related field of ultrasonic diagnostic imaging, teaches modulating the alert based on the determined movement velocity (Weng Fig 9 speedometer display 916).
Before the effective filing date of the claimed invention it would have been obvious to a person of ordinary skill in the art to modify the apparatus in Dalal in view of Kallio and Webster by integrating a speedometer display as in Weng, so as to indicates to the user whether the movement is within acceptable speed limits (Weng Col 14 lines 15-22).
Claims 4-5, 10-11, 16-17 rejected under 35 U.S.C. 103 as being unpatentable over Dalal in view of Kallio as applied to claims 1, 7, 13 above, and further in view of Szapucki [US 20050203331 A1].
As per claims 4, 10, 16, Dalal in view of Kallio further teaches determining a distance of the axial movement of the ablation probe along the trajectory axis from a baseline point on the trajectory axis based on the filtered axial shift data (Dalal ¶0027 “ configured to measure a distance 110 between a point (A) on the sensor 102 and a point (B) on the skin surface 112 (e.g., a distance between points A and B)”).
Dalal in view of Kallio does not expressly teach modulating the alert based on the determined distance.
Szapucki, in a related field of neurological instruments teaches, modulating the alert based on the determined distance (Szapucki 0016 “an output signal generator 17 for providing a surgeon with either an acoustical alarm and/or light emitter of varying intensity depending upon whether the radiation sensor 12 is being moved closer to (increasing intensity) or further ”)
Before the effective filing date of the claimed invention it would have been obvious to a person of ordinary skill in the art to modify the method in Dalal in view of Kallio, by integrating alerting technique as in Szapucki. The motivation would be permitting the surgeon to quickly and easily locate the surgical target location (Szapucki 0004-0005).
As per claims 5, 11, 17, Dalal in view of Kallio and Szapucki further teaches the baseline point corresponds to a location of the ablation probe when a microwave ablation procedure is initiated (Dalal ¶0027 “ configured to measure a distance 110 between a point (A) on the sensor 102 and a point (B) on the skin surface 112 (e.g., a distance between points A and B)”).
Claims 6, 12, 18 rejected under 35 U.S.C. 103 as being unpatentable over Dalal in view of Kallio and Szapucki as applied to claims 4, 10, 16 above, and further in view of Badilini [US 20020172404 A1]
As per claims 6, 12, 18, Dalal in view of Kallio and Szapucki does not expressly teach wherein the baseline point is selectable by a user.
Badilini in a related field of cardiology teaches wherein the baseline point is selectable by a user ( Badilini 0052 “the user clicks a button of mouse 68 over a starting point for baseline 136 and then drags mouse 68 to and releases the mouse button at an ending point for baseline 136”).
Before the effective filing date of the claimed invention it would have been obvious to a person of ordinary skill in the art to modify method in Dalal in view of Kallio and Szapucki by using the interfacing (click and drag) techniques as in Badilini. This would provide capability of manually determining locations from which readings or deviations are calculated, thereby providing access to customizable measurements.
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 OOMMEN JACOB whose telephone number is (571)270-5166. The examiner can normally be reached 8:00-4:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, ANNE M KOZAK can be reached at 571-270-0552. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Oommen Jacob/Primary Examiner, Art Unit 3797