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 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.
Claim(s) 1-5, 7-10, 12-16, 22-24 and 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2020/0078103 to Duindam et al. “Duindam” in view of U.S. Publication No. 2019/0142511 to Wahr et al. “Wahr” and U.S. Publication No. 2012/0184955 to Pivotto et al. “Pivotto”.
As for Claims 1, 10-11, 13, 17-21, 24-25 and 27, Duindam discloses a pulmonary treatment system and method for treating a target within an airway of a subject (Abstract; Figs. 12-13 and corresponding descriptions) comprising a catheter assembly with an ablation assembly (Paragraphs [0049], [0052], [0126]) and a control assembly including a display configured to display a three dimensional (3D) graphical rendering of the airway of the subject for real-time tracking via electromagnetic (EM) tracking of the ablation assembly during treatment of the target tissue (Paragraphs [0035], [0043], [0052]-[0053], [0068]). Duindam discloses wherein the display can include a plurality of virtual markers along the airway and a target marker (e.g. 630 in Fig. 6 and corresponding descriptions) and a virtual roadmap (e.g. 520 in Fig. 5) in the form of a line or tick marks (e.g. plurality of virtual markers) or distance to target tick marks (Paragraph [0078]).
However, Duindam does not expressly disclose wherein the ablation assembly includes both an energy emitting member and a cooling member on an expanded expandable member as claimed. Duindam also does not expressly disclose a step of only emitting energy when the catheter is proximate to the target indicated on the display.
Wahr teaches from within a similar field of endeavor with respect to pulmonary treatment systems and methods to create nerve attenuating lesions (Paragraphs [0007]-[0009]) wherein a catheter assembly includes an ablation means with one or more energy emitters (e.g. RF, microwave, ultrasound emitter) and a cooling means (e.g. cooling supply) on an expandable member (e.g. balloon) (Paragraphs [0014], [0044] and Fig. 5 and corresponding descriptions). Wahr makes it clear that ablation may be monitored under bronchoscope manipulation and visualization (Paragraph [0011]).
Accordingly, one skilled in the art would have been motivated to have modified the catheter assembly described by Duindam with a conventionally known catheter assembly including both an energy emitting ablation means and a cooling means on a balloon member as described by Wahr in order to enhance patient safety during ablation. Such a modification merely involves combining prior art elements according to known techniques to yield predictable results (MPEP 2143).
As for monitoring the location of the device prior to and/or during ablation, Pivotto teaches from within a similar field of endeavor with respect to catheter ablation systems and methods where the position of the catheter can be measured and recorded using fluoroscopy and/or 3D mapping systems such that the operator could monitor the automated targeted operations an could shut off the system if there is any deviation from a planned and targeted ablation procedure (Paragraph [0336]). Pivotto further discloses where ablation may be automatically stopped if the catheter is no longer close enough to the ablation site (e.g. target) (Paragraph [0425]).
Accordingly, one skilled in the art would have been motivated to have modified the pulmonary treatment system and method for treating a target within an airway of a subject described by Duindam with a safety feature that only permits ablation at the target sites seen on the display as described by Pivotto in order to enhance patient safety. Such a modification merely involves combining prior art elements according to known techniques to yield predictable results (MPEP 2143). Examiner notes in the modified system and method, the catheter’s position relative to virtual markers indicating the target would be monitored to determine if ablation is permitted or not and would read on the claimed limitations of emitting energy only when positioned proximate to the target and ceasing to deliver energy when the catheter has been repositioned to another virtual marker not indicative of the target in its broadest reasonable interpretation.
Regarding Claims 2 and 14, Examiner notes that the EM tracking system described above would generate an EM field sufficient to surround a portion of the subject in order to provide the real-time tracking.
With respect to Claim 3, Duindam explains that conventional diagnostic imaging (e.g. CT, MRI, ultrasound, OCT, thermal imaging, etc.) (Paragraph [0042]) may be used to render the airway map in combination with real-time images generated by a bronchoscope (Paragraphs [0052] Figs. 12-13 and corresponding descriptions). Wahr also discloses use of a bronchoscope (Abstract; Paragraphs [0008], [0011] and [0043]).
Regarding Claims 4-5 and 15-16 Duindam explains wherein the system may include sensors (e.g. position sensors, shape sensors or other sensor modalities) configured to sense one or more parameters of the airway and/or the position of the ablation assembly in the airway (Paragraphs [0033] and [0055]). Accordingly, one skilled in the art would have been motivated to have rearranged Duindam’s sensors onto the modified catheter assembly (e.g. on the energy emitter) in order to track the location of the ablation means.
Regarding Claim 7, Wahr discloses wherein the catheter assembly includes a sensor configured to monitor the temperature of the coolant or a pressure sensor (Paragraph [0047]). Examiner notes one skilled in the art would have been motivated to have positioned the monitoring sensor at any position within the ablation assembly in order to monitor the ablation and enhance patient safety.
As for Claims 8 and 22, Duindam discloses wherein the system can create a virtual roadmap indicating a predetermined route leading to a target location along with “tick marks” such as distance to target tick marks (e.g. waypoints; Paragraph [0078]; Figs. 6, 12-13) which is considered to read a plotted position of the device in real time on a rendering of an airway in its broadest reasonable interpretation.
With respect to Claims 9 and 23, Duindam discloses wherein the tracking may take into account alternating motion such as breathing (Paragraph [0048]).
Regarding Claims 12, 26 and the indication step of Claim 27, Duindam discloses wherein data points may be color coded according to the data they represent (Paragraph [0039]) and where road map points (e.g. line) may be colored based on proximity to the target (Paragraphs [0078], [0083]-[0084], [0092]). In addition, target indicators may change when a stage of navigation is complete (Paragraphs [0118]-[0120]) and indicators may be used to indicate locations of “previous procedures”. Accordingly one skilled in the art would have been motivated to have color coded previous procedures (e.g. complete ablations) once they are complete in order to convey pertinent information to the user.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Duindam, Wahr and Pivotto as applied to claims 4 above, and further in view of U.S. Publication No. 2021/0068784 to Hill et al. “Hill”.
As for Claim 6, Duindam, Wahr and Pivotto disclose a pulmonary treatment system and method including monitoring when a catheter assembly reaches a pre-planned target as described above. However, Duindam, Wahr and Pivotto do not expressly disclose an offset location of the sensor.
Hill teaches from within a similar field of endeavor with respect to tracking treatment devices (Abstract) wherein an EM sensor’s spatial relationship is known with respect to the treatment end (e.g. distal end) (Paragraphs [0045] and [0048]).
Accordingly, one skilled in the art would have been motivated to have repositioned the EM sensor at any known, offset position as described by Hill in order to enhance the accuracy of the measurement.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-27 have been considered but are moot in view of the updated grounds of rejection necessitated by amendment.
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 CHRISTOPHER L COOK whose telephone number is (571)270-7373. The examiner can normally be reached M-F approximately 8AM-5PM.
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/CHRISTOPHER L COOK/Primary Examiner, Art Unit 3797
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