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
Applicant’s election of invention I in the reply filed 3/20/2026 is acknowledged.
Claims 1-10 remain pending in the current application.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 1 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim recites a determining a geometric parameter as well as inflation and deflation start times. The limitation of determining parameters and start times as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components. That is, other than reciting that the method is computer implemented nothing in the claim element precludes the step from practically being performed in the mind. For example, but for the computer implemented language, determining parameters and start times in the context of this claim encompasses the user manually analyzing X-ray images. Similarly, the limitation of computing inflation duration, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components. For example, but for the computer implemented language, computing in the context of this claim encompasses the user manually analyzing X-ray images. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea. This judicial exception is not integrated into a practical application. In particular, the claim only recites one additional element – using a processor to perform determining and computing. The processor in both steps is recited at a high-level of generality (i.e., as a generic processor performing a generic computer function of ranking information based on a determined amount of use) such that it amounts no more than mere instructions to apply the exception using a generic computer component. Accordingly, this additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea. The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional element of using a processor to perform both the determining and computing amounts to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. The claim is not patent eligible.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-6, 8, and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Melamud (US 20250325233 A1).
Regarding claim 1, Melamud teaches a computer implemented method for determining an inflation duration of a balloon catheter ([0010] control unit attached to the catheter and configured to receive pressure measurements from the one or more pressure sensors; and to control the inflating unit to control the pressure inside the inflatable balloon based on the received measurements)
determining at least one geometric parameter including a diameter of the balloon catheter based on the sequence of X-ray images, ([0013] image sensors is configured to capture images of the internal shape of said inflatable balloon; [0136] X-Ray imaging)
wherein the diameter is tracked over the sequence of X-ray images receiving a sequence of X-ray images depicting the balloon catheter inside a vessel of a patient ([0026] receiving, optionally in real-time, images from one or more image sensors located inside an inflatable balloon)
determining a first inflation starting time of a first inflation phase, during which the diameter is increasing, based on the diameter; determining a first deflation starting time of a first deflation phase, during which the diameter is decreasing and which lies after the first inflation phase, based on the diameter; and computing the inflation duration depending on a first time difference between the first inflation starting time and the first deflation starting time ([0077] device 200 may include control unit 140 attached to catheter 110 and configured to receive images of the internal shape of inflatable balloon 120 from one or more image sensors 170 and 175; and to control the inflating unit to control the pressure inside inflatable balloon 120 based on the received images. In some embodiments, analysis of the images acquired by the image sensors of the inner surface of the balloon may enable to recreate the shape of the balloon, and thus recreate the pressure profile applied to the balloon by the body cavity; [0045] FIGS. 13A and 13B are a graph and an illustration of measurements of pressure and angle taken using the device; inflation and deflation start and end times and thus inflation durations can clearly be deduced from the graph in fig. 13a)
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Regarding claim 2, Melamud teaches the first inflation starting time is determined as a time of a transition from a first static phase, during which the diameter is essentially constant, to the first inflation phase ([0101] results of pressure measurements from segments (FIG. 13A); [0103] The presented pressure (Ppresented) may be calculated from the pressure reading (Preading) using simple linear equation (1); Ppresented=B+(Preading-PS0)- α; [0104] Where: [0105] B—is the baseline, or the pressure measured by the reference sensor where no external pressure is applied. [0106] PS0—is the pressure reading by the sensor before the pressure was applied. [0107] α—is the coefficient; it can be seen from the graph in fig. 13a that at multiple time points the balloon pressure goes from a plateau phase to a steep incline, indicating the time the balloon began inflating from a static phase)
Regarding claim 3, Melamud teaches the at least one geometric parameter includes a longitudinal end position of the balloon catheter; and where the longitudinal end position is determined to be essentially constant during the first static phase ([0135] catheter 110 of devices 200 and 200A is statically inserted into the rectum or while dynamically moving inside the anal and rectal canals, for example, during deflection; [0090] sealed hollow segments 310A, 310B to 310N are configured to pivotally move one with respect to each other, via connector 318, at least around an axis perpendicular to the longitudinal axis of each sealed hollow segment 310A, 310B to 310N)
Regarding claim 4, Melamud teaches the first deflation starting time is determined as a time of a transition from the first inflation phase to the first deflation phase or as a time of a transition from a second static phase, during which the diameter is essentially constant and which lies between the first inflation phase and the first deflation phase, to the first deflation phase ([0101] results of pressure measurements from segments (FIG. 13A); [0103] The presented pressure (Ppresented) may be calculated from the pressure reading (Preading) using simple linear equation (1); Ppresented=B+(Preading-PS0)- α; [0104] Where: [0105] B—is the baseline, or the pressure measured by the reference sensor where no external pressure is applied. [0106] PS0—is the pressure reading by the sensor before the pressure was applied. [0107] α—is the coefficient; it can be seen from the graph in fig. 13a that at multiple time points the balloon pressure goes from a plateau phase to a steep decline, indicating the time the balloon began deflating from a static phase)
Regarding claim 5, Melamud teaches a first lateral edge position of the balloon catheter and a second lateral edge position of the balloon catheter are determined based on the sequence of X-ray images and the diameter is determined as a distance between the first lateral edge position and the second lateral edge position ([0077] control unit 140 attached to catheter 110 and configured to receive images of the internal shape of inflatable balloon 120 from one or more image sensors 170 and 175; and to control the inflating unit to control the pressure inside inflatable balloon 120 based on the received images. In some embodiments, analysis of the images acquired by the image sensors of the inner surface of the balloon may enable to recreate the shape of the balloon, and thus recreate the pressure profile applied to the balloon by the body cavity, for example, the rectal muscles. In some embodiments, once the pressure profile of the muscle is applied to the balloon, the shape of the balloon is distorted, and the geometrical pattern visible by the cameras is distorted as well. Measuring the difference between the distorted pattern and the known original pattern may allow recreating the shape of the balloon; [0121] the catheter shape may be presented in catheter coordinates, rotated relative to the Earth coordinates; if the geometric shape and coordinates of the balloon are known the lateral edges of the balloon are also known)
Regarding claim 6, Melamud teaches the at least one geometric parameter includes a lateral center position of the balloon catheter, the method further comprising: determining a first lateral distance between the first lateral edge position and the lateral center position and a second lateral distance between the second lateral edge position and the lateral center position; wherein the first lateral distance and the second lateral distance are determined to be essentially equal during a first static phase during which the diameter is essentially constant ([0077] control unit 140 attached to catheter 110 and configured to receive images of the internal shape of inflatable balloon 120 from one or more image sensors 170 and 175; and to control the inflating unit to control the pressure inside inflatable balloon 120 based on the received images. In some embodiments, analysis of the images acquired by the image sensors of the inner surface of the balloon may enable to recreate the shape of the balloon, and thus recreate the pressure profile applied to the balloon by the body cavity, for example, the rectal muscles. In some embodiments, once the pressure profile of the muscle is applied to the balloon, the shape of the balloon is distorted, and the geometrical pattern visible by the cameras is distorted as well. Measuring the difference between the distorted pattern and the known original pattern may allow recreating the shape of the balloon; [0121] the catheter shape may be presented in catheter coordinates, rotated relative to the Earth coordinates; if the geometric shape and coordinates of the balloon are known the center, lateral edges, and distances relating to the balloon as claimed are also known)
Regarding claim 8, Melamud teaches determining a second inflation starting time of a second inflation phase, during which the diameter is increasing and that lies after the first deflation phase, based on the tracked diameter; determining a second deflation starting time of a second deflation phase, during which the diameter is decreasing and that lies after the second inflation phase, based on the tracked diameter; wherein the inflation duration is further computed depending on a second time difference between the second inflation starting time and the second deflation starting time ([0101] results of pressure measurements from segments (FIG. 13A); [0103] The presented pressure (Ppresented) may be calculated from the pressure reading (Preading) using simple linear equation (1); Ppresented=B+(Preading-PS0)- α; [0104] Where: [0105] B—is the baseline, or the pressure measured by the reference sensor where no external pressure is applied. [0106] PS0—is the pressure reading by the sensor before the pressure was applied. [0107] α—is the coefficient; multiple cycles of inflation and deflation can be seen in fig. 13A)
Regarding claim 10, Melamud teaches the computer implemented method is carried out in real-time while the sequence of X-ray images is acquired ([0137] images may be received (optionally in real-time) from one or more image sensors located inside an inflatable balloon attached to a catheter).
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 9 is rejected under 35 U.S.C. 103 as being unpatentable over Melamud.
Regarding claim 9, although Melamud fails to explicitly teach the inflation duration is computed depending on a sum of the first time difference and the second time difference, it would have been obvious to one of ordinary skill in the art to perform this measurement by calculating the area under the curves in fig. 13 a in order to create a 3D pressure map inside balloon 120 based on the pressure measurements (Melamud [0124]).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Melamud as applied to claim 6 above, and further in view of Pollack (US 20230000515 A1).
Regarding claim 7, Melamud fails to teach a first marker position of a first radio-opaque marker of the balloon catheter and a second marker position of a second radio-opaque marker of the balloon catheter based on the sequence of x-ray images; and determining the lateral center position depending on a straight line connecting the first marker position to the second marker position.
However, Pollack teaches a first marker position of a first radio-opaque marker of the balloon catheter and a second marker position of a second radio-opaque marker of the balloon catheter based on the sequence of x-ray images; and determining the lateral center position depending on a straight line connecting the first marker position to the second marker position ([0040] at least one radiopaque marker which indicates an expected bending direction of said penetration tool tip; [0151] the geometry of the tip is identified using an X-ray image. Optionally, one or more fiduciary markers are used to judge the rotational aspect of the tip; [0212] In some embodiments of the invention, small radio-opaque markers are used, which may be more radio-opaque than other parts of the system, for example. In one example, a radio-opaque marker is provided at penetration tip 206. FIG. 16B shows an example radiopaque marker 1650, shaped so that an orientation of the tip 206 can be discerned. In this example, the marker includes an asymmetrical arrangement of radio-opaque portions on either side of a midline, which is optionally also marked with a radio-opaque portion); [0302] FIG. 25A also shows exemplary radio-opaque markers, for example, a radially extreme marker 2512 showing a radial extent of expansion of balloon 2508 and optionally also used to determine an orientation thereof. One or more radio-opaque markers 2514 and 1516 on shaft 2510 are optionally used to indicate an axial start and/or end of an expanding portion of balloon 2508)
Malamud and Pollack are considered analogous because both disclose systems to track invasively implanted medical balloons. Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the pending application to determine a midline of the catheter through a series of radiopaque fiducial markers in order to indicate an expected bending direction of said penetration tool tip (Pollack [0040])
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Janssen (US 20240306929 A1) teaches [abst] Method of determining whether a balloon of a balloon catheter is positioned in the stomach of a person. The balloon catheter comprises a catheter and a balloon. The method comprises the steps of: a) inflating (1401) the balloon and determining (1402) a pressure inside the balloon, until at least one of the following conditions is satisfied: (i) a predefined target volume is inserted in the balloon, and (ii) the determined pressure is larger than a threshold: b) testing (1403) whether the determined pressure (p) is or was larger than the threshold, and if so, deflating (1405) the balloon; and if not, providing (1406) a signal indicative of correct positioning of the balloon catheter. A system comprising a balloon catheter (130), and an inflation device (113), and a pressure sensor, and a control unit (110) for performing such a method, and optionally a food pump (112)
Wesselmann (US 20220288359 A1) teaches [abst] A balloon catheter system includes a balloon extending in an axial direction. A stent is crimped onto an outer surface of the balloon. A catheter is connected to the balloon and includes a lumen in fluid communication with a balloon interior of the balloon. At least one sensor associated with the balloon measures expansion of the balloon in a radial direction (R). A processing unit receives a signal from the at least one sensor and is connected to terminate filling of the balloon interior with a fluid medium (M) and/or to prompt a display device to output a display if the signal reaches a threshold value above a predefined reference value, the signal being indicative of a current diameter (D) of the balloon in the radial direction (R), the reference value corresponding to a balloon diameter upon contact of a proximal and/or distal balloon end with a vessel wall, and the threshold value exceeding the reference value by 5% to 20%
Quint (US 20240198061 A1) teaches [abst] A balloon catheter system has a catheter with a catheter shaft surrounding a lumen. A balloon is connected to a distal end of the catheter shaft such that a fluid inflation medium can be introduced into or removed from a balloon interior via the lumen. A pressure sensor is configured to measure an instantaneous pressure (p) of the inflation medium in the lumen during inflation and/or deflation of the balloon. A flow sensor is configured to measure an instantaneous volume flow (v) of the inflation medium during the inflation and/or deflation. An evaluation unit is configured to record the instantaneous pressure and the instantaneous volume flow and to determine therefrom a time curve of the flow resistance (R)
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GABRIEL VICTOR POPESCU whose telephone number is (571)272-7065. The examiner can normally be reached M-F 8AM-5PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anne 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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/GABRIEL VICTOR POPESCU/ Examiner, Art Unit 3797 /SERKAN AKAR/Primary Examiner, Art Unit 3797
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