DETAILED ACTION
Applicant's preliminary amendments and remarks, filed 3/14/24, are fully acknowledged by the Examiner. Currently, claims 1-15 are pending with claims 1-14 amended. The following is a complete response to the 3/14/24 communication.
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 (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.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 12 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 12 recites the limitation "the output data" in line 1. There is insufficient antecedent basis for this limitation in the claim.
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.
Claim(s) 1-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Coulombe (US 2020/0179029) in view of Brannan (US 2016/0051327).
Regarding claim 1, Coulombe teaches a processing system for aiding a balloon ablation therapy procedure that uses an ablation balloon to occlude an anatomical cavity of a subject during the balloon ablation therapy procedure (balloon 26 to occlude a cavity as in Fig. 3), the processing system comprising:
an input interface configured to receive input data representing a plurality of electrical signals obtained from a plurality of electrodes disposed in the vicinity of the ablation balloon (56 with a receiving function that receives input data from electrodes 30 as in par. [0043]);
a processing unit communicatively coupled to the input interface and configured to process the plurality of electrical signals contained in the input data to produce a combined signal (56 with a processing function to process electrical signals for a combined signal of occlusion as in par. [0043]), wherein each one of the plurality of electrical signals contributes to the combined signal only when one or more characteristics of said electrical signal meets one or more predetermined criteria (temperature sensed by electrodes contributes to a signal, but only when balloon 26 reaches ablation temperature, as in par. [0040] and [0043]).
Coulombe teaches injecting fluid into a cavity (saline), but is not explicit wherein each one of the plurality of electrical signals is sensitive to the presence of a dielectric medium injected into the anatomical cavity.However, Brannan teaches use of a saline injected near a balloon to alter the dielectric constant and ablation of a region (par. [0028] and [0091]).It would have been obvious to one of ordinary skill in the art that the injected saline of Coulombe would be a dielectric medium that alters the dielectric constant of a region, as in Brannan, in order to alter the delivered signals.
Regarding claim 2, Coulombe teaches wherein the combined signal is a single, time-dependent value (occlusion dependent in part, on time).
Regarding claim 3, Coulombe teaches wherein the one or more characteristics of the electrical signal comprise an amplitude of the electrical signal and the one or more predetermined criteria comprise the amplitude of the electrical signal breaching a first predetermined threshold (temperature sensed amplitude, and the threshold as the ablation temperature as in par. [0040]).
Regarding claim 4, Coulombe teaches wherein the plurality of electrodes are arranged around a hypothetical closed shape in the anatomical cavity (electrodes 30 around a catheter of the device as in Fig. 3).
Regarding claim 5, Coulombe teaches wherein the plurality of electrodes are positioned distally of the ablation balloon in the anatomical cavity and/or upstream of a blood flow direction through the anatomical cavity (electrodes 30 distal of the balloon as in at least Fig. 3 and abst.).
Regarding claim 6, Coulombe teaches wherein the one or more characteristics of the electrical signal comprise a gradient of the amplitude of the electrical signal (change over time as in par. [0042]) and the one or more predetermined criteria comprises the gradient of the amplitude of the electrical signal breaching a second predetermined threshold (change over time in temperature as a threshold as in par. [0042]).
Regarding claim 7, Coulombe teaches wherein: each electrical signal and the combined signal is time dependent (temperature changes over time during an ablation procedure); and each electrical signal only contributes to the combined signal (par. [0043]), at a particular point in time for the combined signal (par. [0043]), when one or more characteristics of the electrical signal at the particular point in time meets one or more predetermined criteria (only when ablation temperature reached as in par. [0040]).
Regarding claim 8, Coulombe teaches wherein the combined signal comprises a sum of the electrical signals that contribute to the combined signal (par. [0043] data from all electrodes used).
Regarding claim 9, Coulombe teaches wherein: the input data represents each electrical signal as a sequence of sampled values (sequence of values as in Figs. 6a-8c), wherein each sampled value represents a sample of the electrical signal at the respective electrode at a respective point in time and each sequence is of a same length (value at a point in time as the graph figures); and the combined signal comprises a sequence of combined values having a same length as each sequence of sampled values (par. [0037] values at a set point in time), each combined value corresponding to a respective sampled value from each sequence of sampled values (par. [0037] changes in value at different times evaluated to determine different occlusion ratings), wherein each corresponding sampled value contributes to the combined value only when one or more characteristics of the sampled value meets one or more predetermined criteria (temperature sensed by electrodes contributes to a signal, but only when balloon 26 reaches ablation temperature, as in par. [0040] and [0043]).
Regarding claim 10, Coulombe teaches wherein the value of each combined value is a sum of the sampled values that contribute to the combined value (par. [0043] data from all electrodes used).
Regarding claim 11, Coulombe teaches wherein each electrical signal comprises a difference between an electrical response of the respective electrode and an electrical response of a reference electrode (reference electrode 34 as in par. [0025], [0030]).
Regarding claim 12, Coulombe teaches wherein the output data comprises a waveform representing the combined signal (audio alert output as in par. [0043]).
Regarding claim 13, the combination teaches a system for aiding a balloon ablation therapy procedure, the system comprising: the processing system of claim 12 (see claim 12 rejection); and
a control device (input as in par. [0028]) configured to:
communicate with the plurality of electrodes (controls interacting with computer that is in electrical communication with electrodes 30 as in par. [0028]); and
control the plurality of electrodes to provide local electric fields and measure the response to the local electric fields (user controls to control electrodes as in par. [0028]).
Regarding claim 14, Coulombe teaches a computer-implemented method for aiding a balloon ablation therapy procedure that uses an ablation balloon to occlude an anatomical cavity of a subject during the balloon ablation therapy procedure (balloon 26 as in Fig. 3 occluding a cavity of a subject), the computer-implemented method comprising:
receiving input data representing a plurality of electrical signals (56 receives input data from electrodes 30 as in par. [0043]), each electrical signal being measured by a respective one of a plurality of electrodes disposed in the vicinity of the ablation balloon (measuring electrodes 30 as in par. [0043]);
processing the plurality of electrical signals contained in the input data to produce a combined signal (56 processes the signals to produce a combined signal as in par. [0053]), wherein each one of the plurality of the electrical signals contributes to the combined signal only when one or more characteristics of said electrical signal meets one or more predetermined criteria (temperature sensed by electrodes contributes to a signal, but only when balloon 26 reaches ablation temperature, as in par. [0040] and [0043]).Coulombe teaches injecting fluid into a cavity (saline), but is not explicit wherein each one of the plurality of electrical signals is sensitive to the presence of a dielectric medium injected into the anatomical cavity.However, Brannan teaches use of a saline injected near a balloon to alter the dielectric constant and ablation of a region (par. [0028] and [0091]).It would have been obvious to one of ordinary skill in the art that the injected saline of Coulombe would be a dielectric medium that alters the dielectric constant of a region, as in Brannan, in order to alter the delivered signals.
Regarding claim 15, the combination teaches a computer program product comprising computer program code (at least pars. [0010], [0028]) means which, when executed on a computing device having a processing system, cause the processing system to perform all of the steps of the method according to claim 14 (see the rejection to claim 14).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Ingle (US 2009/0326526) teaches an occlusion balloon for an ablation procedure, with sensing components.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BO OUYANG whose telephone number is (571)272-8831. The examiner can normally be reached M-F 8-5 EST.
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/BO OUYANG/Examiner, Art Unit 3794
/MICHAEL F PEFFLEY/Primary Examiner, Art Unit 3794