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 .
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 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.
Status of the Claims
The current office action is made responsive to claims filed 5/11/2026.
Acknowledgement is made to the cancellation of claims 7-16.
Acknowledgement is made to applicant’s election without traverse of Invention I, claims 1-6 and 17-26.
Any claims listed above as cancelled have sufficiently overcome any rejections set forth in any of the prior office actions.
Claims 1-6 and 17-26 are pending. A complete action on the merits appears below.
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.
Claims 1-6 are rejected under 35 U.S.C. 103 as being unpatentable over Nair (US 20140180273 A1) in view of Lakkireddy (US 20190223734 A1) and Noonan (US 20190000575 A1).
Regarding claim 1, Nair teaches a method for treating a disorder ([0173]), comprising:
generating an image of an area to be treated ([0174] teaches utilizing the imaging apparatus to obtain images of the target area);
generating a treatment plan of the area, the treatment plan comprising a target location at which to apply a computed dose of treatment energy ([0179] teaches determining the treatment plan based on the imaging data of the target area);
steering a catheter to the treatment location, the catheter configured to deliver the treatment energy ([0173]); and
applying the computed dose of treatment energy at the target location ([0188]).
However, Nair fails to teach the method for treating a disorder as being treating an area having a disorder of the bronchial tree.
Nair instead teaches the methods as being relevant to a variety of ablation applications, such as cardiac ablation ([0209]).
Lakkireddy teaches a method for managing and treating tissue during a medical procedure which includes imaging the tissue and applying an ablation to the tissue (Abstract).
Lakkireddy further teaches the ablation as being cardiac ablation or bronchial tissue ablation (Abstract).
Therefore, it would have been obvious to a person having ordinary skill before the effective filing date to have substituted the cardiac ablation as is taught by Nair with the bronchial tissue ablation as is taught by Lakkireddy as both forms of ablation perform the same function of treating patient tissue within methods for managing and treating tissue during medical procedures which involve tissue imaging, as is taught by Lakkireddy and it has been held that substituting parts of an invention which perform the same function involves only routine skill in the art. MPEP 2144.06(II).
Nair further fails to teach the catheter as being a robotic catheter.
Noonan teaches a system which treats patient tissue by a procedure, such as a cardiac ablation, by the use of a surgical device, such as an ablation catheter, based on a provided surgical plan (Abstract, [0034]).
Noonan further teaches the procedure as being performed either manually or robotically ([0068]).
Therefore, it would have been obvious to a person having ordinary skill before the effective filing date to have substituted the catheter as is taught by Nair with the catheter being robotic as is taught by Noonan as both manually or robotically controlled catheters perform the same function of performing procedures within the anatomy of a patient, as is taught by Noonan, and it has been held that substituting parts of an invention which perform the same function involves only routine skill in the art. MPEP 2144.06(II).
Regarding claim 2, Nair teaches the method of claim 1, wherein the image is a three- dimensional image obtained using at least one of a CT scan or MRI imaging ([0173]).
Regarding claim 3, Nair teaches the method of claim 1, wherein the energy comprises one or more of thermal energy ([0059]), non-thermal ablation energy, a pulsed electrical field, irreversible electroporation, dielectrophoresis, or mechanical energy.
Regarding claim 4, Nair teaches the method of claim 1, wherein applying the computed dose of treatment energy comprises applying the treatment energy with the catheter while moving the catheter in a region including the target location ([0106]- [0108]).
While Nair does not specifically teach continuously applying the treatment energy, Applicant has not disclosed that this being continuous produces an unexpected result and it has been held that separation of parts is an obvious modification (MPEP 2144.04(V)(E)).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to have provided any functional process such as that of applying the treatment energy as is taught by Nair as being performed continuously as long as each functional element retains its ability to function in a desired and predictable manner.
Regarding claim 5, Nair teaches the method of claim 1, wherein the treatment location comprises a wall of a body lumen ([0065]), and further comprising programmatically positioning the catheter within the body lumen based on the treatment plan ([0173]).
Regarding claim 6, Nair teaches the method of claim 1, further comprising identifying a second target location as part of the treatment plan, and automatically maneuvering the catheter to the second target location after applying the computed dose of treatment energy ([0177]).
In accordance with the above provided rejection, Noonan teaches the catheter as being robotic ([0068]).
Claim 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Viswanathan (US 10842572 B1) in view of Lakkireddy (US 20190223734 A1).
Regarding claim 17, Viswanathan teaches a method for treating a disorder, comprising:
generating an image of an area to be treated (Col. 12, Lines 40-65);
displaying the image on a console display (Col. 18, Lines 32-35);
overlaying the displayed image with a visual element indicating a previous dose applied to a treatment location (Fig. 12; ablation zones 1220, 1222, 1224);
moving a catheter to the treatment location, the catheter configured to deliver treatment energy (Col. 18, Lines 15-30); and
applying a dose of treatment energy at the target location (Col. 18, Lines 15-30).
However, Viswanathan fails to teach the area of the disorder being treated as being the bronchial tree.
Viswanathan instead teaches the methods as being relevant to a variety of ablation applications, such as cardiac ablation (Col. 5, Lines 35-40).
Lakkireddy teaches a method for managing and treating tissue during a medical procedure which includes imaging the tissue and applying an ablation to the tissue (Abstract).
Lakkireddy further teaches the ablation as being cardiac ablation or bronchial tissue ablation (Abstract).
Therefore, it would have been obvious to a person having ordinary skill before the effective filing date to have substituted the cardiac ablation as is taught by Viswanathan with the bronchial tissue ablation as is taught by Lakkireddy as both forms of ablation perform the same function of treating patient tissue within methods for managing and treating tissue during medical procedures which involve tissue imaging, as is taught by Lakkireddy and it has been held that substituting parts of an invention which perform the same function involves only routine skill in the art. MPEP 2144.06(II).
Regarding claim 18, Viswanathan teaches the method of claim 17, wherein the dose of treatment energy is applied based on a computed dosage amount determined by the console (Col. 17, Lines 12-28 teaches the claim limitation as broadly as is currently claimed).
However, Viswanathan fails to teach the application being automatic.
While Viswanathan does not specifically teach the application as being automatic, Applicant has not disclosed that these components being automated produces an unexpected result and it has been held that automation of a manual activity is an obvious modification (MPEP 2144.04(III)).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to have provided any manual activity such as the application of energy as is taught by Viswanathan as being automated as long as each functional element and/or activity retains its ability to function in a desired and predictable manner.
Claim 19-20, 23, and 25-26 are rejected under 35 U.S.C. 103 as being unpatentable over Viswanathan (US 10842572 B1) in view of Lakkireddy (US 20190223734 A1) further in view of Noonan (US 20190000575 A1).
Regarding claim 19, Viswanathan teaches the method of claim 17, wherein moving the catheter to the treatment location comprises moving the catheter using a system based on a treatment plan stored at the console (Col. 7, Lines 5-10).
However, Viswanathan fails to teach the movement being automatic.
While Viswanathan does not specifically teach the movement as being automatic, Applicant has not disclosed that these components being automated produces an unexpected result and it has been held that automation of a manual activity is an obvious modification (MPEP 2144.04(III)).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to have provided any manual activity such as the movement as is taught by Viswanathan as being automated as long as each functional element and/or activity retains its ability to function in a desired and predictable manner.
Viswanathan further fails to teach the system as being a robotic system
Noonan teaches a system which treats patient tissue by a procedure, such as a cardiac ablation, by the use of a surgical device, such as an ablation catheter, based on a provided surgical plan (Abstract, [0034]).
Noonan further teaches the procedure as being performed either manually or robotically ([0068]).
Therefore, it would have been obvious to a person having ordinary skill before the effective filing date to have substituted the catheter as is taught by Viswanathan with the catheter being robotic as is taught by Noonan as both manually or robotically controlled catheters perform the same function of performing procedures within the anatomy of a patient, as is taught by Noonan, and it has been held that substituting parts of an invention which perform the same function involves only routine skill in the art. MPEP 2144.06(II).
Regarding claim 20, Viswanath teaches the method of claim 17, further comprising receiving confirmation from a user of the console, and sending a command signal to apply the dose of treatment energy in response to receiving the confirmation, wherein the console is configured not to apply the dose in the absence of the command signal (Col. 18, Line 55- Col. 19, Line 15).
Regarding claim 23, Viswanathan teaches the method of claim 21, wherein the visual element comprises a color filter based on one or more previous locations of the catheter during one or more previous dose applications (Col. 7, Lines 15-25).
Regarding claim 25, Viswanathan teaches the method of claim 23, wherein the previous locations of the catheter are determined by the console using information that is indicative of locations where energy has been previously applied (Col. 18, Lines 55-65).
Regarding claim 26, Viswanathan teaches the method of claim 24, wherein the previous locations of the catheter are determined by the console using information that is indicative of locations where energy has been previously applied (Col. 18, Lines 55-65).
Claim 21-22 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Viswanathan (US 10842572 B1) in view of Lakkireddy (US 20190223734 A1) further in view of Ryan (US 20180049622 A1).
Regarding claim 21, Viswanathan teaches the method of claim 17, further comprising generating a map of the treatment area while navigating the catheter using image recognition software ([0072]).
In accordance with the above rejection, Lakkireddy further teaches the treatment area as being the bronchial tree (Abstract).
However, Viswanathan fails to teach the map as being three- dimensional.
Ryan teaches a surgical navigation system which uses sensed data to provide a map of the surface of the anatomical object of interest (Abstract).
Ryan further teaches the mapping of the surface as being 3D to guide the surgeon ([0125]).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the map as being 3D, as is taught by Ryan, into the mapping as is taught by Viswanathan, to produce the predictable result of guiding the surgeon using a mapping, as is taught by Ryan, as it has been held that the incorporation and/or combination of prior art elements according to known methods to yield predictable results is an obvious modification. MPEP 2141(III).
Regarding claim 22, Ryan further teaches the method of claim 21, wherein the three-dimensional map is a mesh map ([0125]).
Regarding claim 24, Viswanathan further teaches the method of claim 21, wherein the visual element comprises one or more reference points based on one or more previous locations of the catheter during one or more previous dose applications (Fig. 12; shows the expected ablation zone with reference to the points of the previously ablated zones).
However, Viswanathan further fails to teach the reference points as specifically being fiducial reference points.
Ryan teaches the known use of visual markers to visually track a distinct object, such as a location within an anatomical object ([0079]).
Ryan further teaches the known use of the markers as being fiduciary markers ([0099]).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the markers as being fiduciary markers, as is taught by Ryan, into the reference points as is taught by Viswanathan, to produce the predictable result of visually tracking an object such as a location of an anatomical object, as is taught by Ryan, as it has been held that the incorporation and/or combination of prior art elements according to known methods to yield predictable results is an obvious modification. MPEP 2141(III).
Conclusion
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/L.R.L./Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
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