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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 14 January 2026 has been entered.
Response to Amendment
The amendments filed 16 December 2025 have been entered. Applicant’s amendments have overcome each and every rejection under 35 U.S.C. 112(b) previously set forth in the Office Action mailed 16 September 2025.
Claim Objections
Claim 9 is objected to because of the following informalities:
In claim 9, line 2-3 “wherein one of the plurality of different regimes each indicate different patterns of peristaltic pumping” should be --wherein each [[one]] of the plurality of different regimes s different patterns of peristaltic pumping—or similar.
Appropriate correction is required.
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.
Utilizing the two step process adopted by the Supreme Court (Alice Corp vs CLS Bank Int'l, US
Supreme Court, 110 USPQ2d 1976 (2014) and the recent 101 guideline Federal Register Vol. 84, No., Jan
2019)), determination of the subject matter eligibility under the 35 U.S.C. 101 is as follows: Specifically, the Step 1 requires claim belongs to one of the four statutory categories (process, machine, manufacture, or composition of matter). If Step 1 is satisfied, then in the first part of Step 2A (Prong One), identification of any judicial recognized exceptions in the claim is made. If any limitation in the claim is identified as judicial recognized exception, then in the second part of Step 2A (Prong Two), determination is made whether the identified judicial exception is being integrated into practical application. If the identified judicial exception is not integrated into a practical application, then in Step 2B, the claim is further evaluated to see if the additional elements, individually and in combination provide "inventive concept" that would amount to significantly more than the judicial exception. If the element and combination of elements do not amount to significantly more than the judicial recognized exception itself, then the claim is ineligible under the 35 U.S.C. 101.
Claims 1-17 are rejected under 35 U.S.C. 101.
Claim 1 is rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception, in this case an abstract idea, without significantly more. The claim recite(s) "inputting the planimetry data and the pressure data to a reduced order model using a computer system, generating output as flow data; (d) computing, with the computer system, muscular work data to provide a health assessment of the lumen; (e) generating a regime map using the computer system and classifying the flow data into one of a plurality of different regimes, wherein each regime corresponds to a deformation pattern observed in the planimetry catheter based on a response of a wall of the lumen and allows identification of specific causes of muscular dysfunction". This judicial exception is not integrated into a practical application and the claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception.
Claim 1 satisfies Step 1, namely the claim is directed to one of the four statutory classes, process. Following Step 2A Prong one, any judicial exceptions are identified in the claims. In claim 1, the limitations "inputting the planimetry data and the pressure data to a reduced order model using a computer system, generating output as flow data; (d) computing, with the computer system, muscular work data to provide a health assessment of the lumen; (e) generating a regime map using the computer system and classifying the flow data into one of a plurality of different regimes, wherein each regime corresponds to a deformation pattern observed in the planimetry catheter based on a response of a wall of the lumen and allows identification of specific causes of muscular dysfunction" are abstract ideas as they are directed to a mental process or mathematical concept as the limitation is broadly encompasses utilizing any perceived relationship between the planimetry data and pressure data to generate some output flow data which may thus include relationships simple enough to be utilized in the human mind as well as mathematical concepts such as specific mathematical relationships between the data, wherein classification of data into regimes may be either of a simple judgment or mathematical operation based on, for example, different threshold values, and the generation of a regime map may be done following this classification either mentally or with the aid of pen and paper. With the identification of an abstract idea, the next phase is to proceed Step 2A, Prong Two, wherewith additional elements and taken as a whole, evaluation occurs of whether the identified abstract idea is integrated into a practical application.
In Step 2A, Prong Two, the claim does not recite any additional elements or evidence that amounts to significantly more than the judicial exception. Besides the abstract idea, the claim recites the additional elements “(a) acquiring planimetry data with a planimetry catheter; (b) acquiring pressure data with the planimetry catheter” and “(f) storing the flow data, muscular work data, and regime map in a memory of the computer system”. However, these elements may be seen as the use of well-understood, routine, or conventional elements to perform a non-mental process in order to gather data for the mental process step, much like the example given in MPEP 2106.04(d)(2)(c), such that these limitations are extra-solution activity and thus do not integrate the judicial exception into a practical application. The acquisition steps lead to the final limitation of “generating output as flow data” such that the end result of use of the system is only the creation of data which may include any generic output, or no output at all. As this determination is not defined as requiring any further action, such as a form of prophylaxis or treatment or an improvement to a computer or other technology, the claim limitations constitute mere generation of data, in this case the measurement of data relating to first and second physiological information (in this case, planimetry data and pressure data), such that the claim does not integrate the judicial exception into any practical application. Regarding the step of “computing, with the computer system, muscular work data to provide a health assessment of the lumen”, this step as claimed appears to similarly create data which may include any generic output, or no output at all. Regarding “a computer system”, the limitation amounts to nothing more than an instruction to apply the abstract idea using a generic computer, which does not render an abstract idea eligible. The steps performed by the computer system are, as claimed, capable of being performed in the human mind similar to the examples given in MPEP 2106.04(a)(2)(III)(A)-(C), wherein it is described that “a claim to ‘collecting information, analyzing it, and displaying certain results of the collection and analysis’ where the data analysis steps are recited at a high level of generality such that they could practically be performed in the human mind” recites a mental process and that claims which merely use a computer as a tool to perform a mental process are not eligible when “there is nothing in the claims themselves that foreclose them from being performed by a human, mentally or with pen and paper” such as “mental processes of parsing and comparing data” when the steps are recited at a high level of generality and a computer is used merely as a tool to perform the processes. Furthermore, “inputting the planimetry data and the pressure data to a reduced order model using the computer system, generating output as flow data” may further be seen as a mathematical concept as the broadest reasonable interpretation may be seen to claim merely a mathematical relationship between the planimetry and pressure data and flow data via some mathematical model; the additional limitations similarly fail to integrate this judicial exception into a practical application as they serve as elements of mere data gathering and a mere instruction to apply the abstract idea (the mathematical concept of this relationship between the data) using a generic computer environment. Under the broadest reasonable interpretation, the claim elements are recited with a high level of generality (as written, each claimed step of the process may be performed by a person in an undefined manner) that there are no meaningful limitations to the abstract idea. Consequently, with the identified abstract idea not being integrated into a practical application, the next step is Step 2B, evaluating whether the additional elements provide "inventive concept" that would amount to significantly more than the abstract idea.
In Step 2B, claim 1 does not include additional elements that are sufficient to amount to significantly more than the judicial exception. The limitation of “(a) acquiring planimetry data with a planimetry catheter; (b) acquiring pressure data with the planimetry catheter” and “(f) storing the flow data in a memory of the computer system” and “storing the flow data, muscular work data, and regime map in a memory of the computer system” constitutes extra-solution activity to the judicial exception, which does not amount to an inventive concept when the activity is well-understood, routine, or conventional, and are thus not indicative of integration into a practical application. The claim limitation constitutes adding a generic planimetry catheter and a generic computer, which McMahon (US 20080161730 A1) describes as well-understood, routine, or conventional in its description of the longstanding use of impedance planimetry to determine features of a lumen (Paragraph 0010--During the past two decades, impedance planimetry has been used in gastroenterology to determine wall tension and strain in animal experiments and human studies. Impedance planimetry provides a measure of cross-sectional area in the LOS and is therefore a better basis than manometry measurement for determination of compliance in the sphincters of the GI tract) and using a personal computer to receive, analyze, and record data (Paragraph 0045, 0064). It is additionally noted that the instant specification discloses that catheter used in the method may be a well-understood, routine, or conventional element (see paragraphs 0023--can utilize data captured by standard planimetry catheters during clinical use; paragraph 0026--For instance, the balloon dilation catheter can be an endolumenal functional lumen imaging probe (EndoFLIP; Crospon, Ireland) or other such device capable of measuring planimetry and pressure data.). As discussed above with respect to integration of the abstract idea into a practical application, the present elements amount to no more than mere indications to apply the exception.
In Summary, claim 1 recites abstract idea without being integrated into a practical application, and does not provide additional elements that would amount to significantly more. As such, taken as a whole, the claim and is ineligible under the 35 U.S.C. 101.
Claims 2-17 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception, in this case an abstract idea, without significantly more. As each of these claims depends from claim 1, which was rejected under 35 U.S.C. 101 in paragraph 7 of this action, these claims must be evaluated on whether they sufficiently add to the practical application of claim 1, or comprise significantly more than the limitations of claim 1.
Besides the abstract idea of claim 1, claims 2-7 may further encompass additional details of the mental step or mathematical concept of generating output as flow data; claims 8-9 and 17 recite additional limitations of the planimetry data and pressure data which may be similarly seen as extra solution activity as described in claim 1 and additional mental step limitations such as “generating…muscular work data” and additional details of the mental process classification step; claims 10-16 recite further extra-solution limitations of the extra solution activity as described in claim 1.
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) 1-4, 6, 9-15, and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over McMahon (US 20080161730 A1) in view of Franco (US 20190350511 A1).
Regarding claim 1, McMahon teaches a method for generating flow data from planimetry data acquired with a planimetry catheter positioned within a lumen (Paragraph 0043-0048--impedance planimetry can be used to describe the geometric and mechanical characteristics of luminal areas), the method comprising:
(a) acquiring planimetry data with a planimetry catheter (Paragraph 0043-0048—geometry of the sphincter or other narrowing region may be obtained by using a multi-electrode planimetry system, said system being capable of measuring multiple cross-sectional areas along the length of the balloon…method of measurement from an impedance planimetry version of the apparatus…; paragraph 0064-0066, 0071--While the balloon is inflated data on pressure inside the balloon, pressure at the distal end of the catheter, pressure at the proximal end of the catheter and multiple cross sectional areas (CSAs) inside the balloon may be recorded on a personal computer and then they can be used to construct a 3 dimensional geometric surface profile of the sphincter);
(b) acquiring pressure data with the planimetry catheter (Paragraph 0043-0048--the apparatus is provided with means for measuring at least one of the following physical properties of the balloon…the strain of the balloon, the pressure of a fluid inside the balloon; paragraph 0052—cross-sectional area (CSA) measured at a certain pressure; paragraph 0064-0066, 0071--While the balloon is inflated data on pressure inside the balloon, pressure at the distal end of the catheter, pressure at the proximal end of the catheter and multiple cross sectional areas (CSAs) inside the balloon may be recorded on a personal computer and then they can be used to construct a 3 dimensional geometric surface profile of the sphincter; paragraph 0075--The pressure of the fluid is monitored, possibly by a pressure gauge inside the balloon. Alternatively to measuring the pressure, the volume of the fluid being pumped may be monitored, either when being pumped to the balloon or after having been pumped to the balloon);
(c) inputting the planimetry data and the pressure data to a reduced order model using a computer system, generating output as flow data (Paragraph 0026, 0038-0041--distension can be used to derive pressure-cross sectional area (CSA) and pressure-diameter diagrams with subsequent evaluation of the circumferential wall tension, force of closure, strain, compliance and flow characteristics. In relation to the wall tension, it is the active, passive and total forces inducing tension and stress, which is derived. This length-tension test provides data on the passive nature of the tissue, on the maximum force generated by the smooth muscle, and the strain corresponding to the maximum force; Paragraph 0078--Data collected on the multiple CSAs, volume and pressure inside the balloon could be used to calculate wall tension, to derive force data such as total force and passive force. Strain may be calculated from data on volume, diameter and CSA; paragraph 0102-0104-- Calculations of flow through the LOS during swallowing can also be made when the probe is in situ in the sphincter. The patient performs both water and air swallows and the CSA and pressure readings are recorded for the relaxation of the LOS as a result of the swallows. Using Newton's law of motion applied to force, rates for air and water in both the control and patient groups can be estimated using the following equation Q =.DELTA.P* D4/CVL where Q=flow rate, .DELTA.P=Pressure Difference, D=Diameter, C=Constant, V=Viscosity, L=length);
(d) computing, with the computer system, muscular work data (Paragraph 0026, 0038-0041--distension can be used to derive pressure-cross sectional area (CSA) and pressure-diameter diagrams with subsequent evaluation of the circumferential wall tension, force of closure, strain, compliance and flow characteristics. In relation to the wall tension, it is the active, passive and total forces inducing tension and stress, which is derived. This length-tension test provides data on the passive nature of the tissue, on the maximum force generated by the smooth muscle, and the strain corresponding to the maximum force);
(e) generating a regime map using the computer system and classifying the flow data into one of a plurality of different regimes, wherein each regime corresponds to a deformation pattern observed in the planimetry catheter based on a response of a wall of the lumen and allows identification of specific causes of muscular dysfunction (Paragraph 0011, 0023-0026, 044-0047, 0102--applying stimuli to sphincters in the GI tract and to simultaneously measure physical properties of the apparatus applying the stimuli, which are representative of the response of the stimulated sphincter…it is possible to make multiple cross-sectional area or diameter measurements in an axial direction such that a three-dimensional profile of the balloon can be obtained and analysed with respect to geometry and mechanical parameters… Development of balloon distension protocols is useful in order to correlate biomechanics, motor control, sensation and the valvular action of the LOS, in particular in the gastrointestinal tract in vivo and in vitro. The distension can be used to derive pressure-cross sectional area (CSA) and pressure-diameter diagrams with subsequent evaluation of the circumferential wall tension, force of closure, strain, compliance and flow characteristics… Signal analysis from the apparatus may include reconstruction of three dimensional geometry…; paragraph 0064-- data on pressure inside the balloon, pressure at the distal end of the catheter, pressure at the proximal end of the catheter and multiple cross sectional areas (CSAs) inside the balloon may be recorded on a personal computer and then they can be used to construct a 3 dimensional geometric surface profile of the sphincter). In particular, it is noted that as changes in pressure or flow are mechanical parameters which may be measured and used to create a 3D map of the surface of the lumen, the determined surface profile may correspond to a classification of the data into a regime as it relates to the determined 3D properties and subsequent formation of a regime map based on this data which can allow identification of causes of muscular dysfunction such as narrowing, inflammation, etc. (see also claim 41 of McMahon-- means for deriving data from the measuring means on change of geometry and the force-deformation relationship establishing change of geometry, lumen dynamics or tissue properties of the sphincter or narrowing region caused by a disease or a treatment). For example, the flow may be seen to be classified into regimes which correspond to narrowing or widening of the lumen such that the regime map of the 3D profile may demonstrate deformation patterns observed based on the response of the wall of the lumen.
(f) storing the flow data, other data, and regime map in a memory of the computer system (Paragraph 0042—means for recording flow of fluid; paragraph 0045-- Electronic hardware and software used to interpret, display, make calculations from and store data).
McMahon additionally discloses that work-related data may correspond to a health of a lumen (Paragraph 0010-011--Impedance planimetry provides a measure of cross-sectional area in the LOS and is therefore a better basis than manometry measurement for determination of compliance in the sphincters of the GI tract…Achalasia which is an uncommon primary oesophageal motor disorder that is characterized by incomplete relaxation of the LOS on swallowing and an absence of peristalsis of the oesophageal body).
However, McMahon fails to explicitly disclose computing, with the computer system, muscular work data to provide a health assessment of the lumen.
Franco, in the same field of endeavor of a method for monitoring a lumen of a body based on data acquired by a catheter (Abstract), discloses a method including computing, with a computer system, muscular work data (Paragraph 0037-0040-- Work in thermodynamics for a closed cavity is represented by dw=Pdv. Thus, the change in work is equal to the pressure times the change in volume. Accordingly, the inventors have determined that the work done by a bladder (or done when filling or voiding the bladder) is equal to the mathematical integral of the aforementioned equation or otherwise stated W=∫.sub.0.sup.V Pdv where V is the final volume and P is the pressure for each delta V.) to provide a health assessment of the lumen (Paragraph 0037-0040, 0055-0056, 0068-- the inventors have determined that such work at various sections of a P v V (pressure v volume) curve may result in improved and more quantitative means for determining whether the detrusor muscle is actuating too frequently, for example, which would be represented by an increased amount of work or, in the case of underactive bladder, where the detrusor muscle is not actuating enough at certain stages (such as during micturition)…to determine the work done by the bladder from the area under a pressure vs. volume curve (hereinafter referred to as a urodynamic curve) and use that work to determine abnormality of bladder functions… The result is a more standardized means of determining a healthy or unhealthy bladder).
Franco additionally teaches generating a regime map using the computer system and classifying the flow data into one of a plurality of different regimes, wherein each regime corresponds to a deformation pattern observed in the planimetry catheter based on a response of a wall of the lumen and allows identification of specific causes of muscular dysfunction (Paragraph 0060-0061-- flow curves and the distinctive patterns associated with these curves such as; bell, plateau, tower, interrupted and staccato, in one aspect, are calculated and used to define certain medical conditions associated with abnormal urination. For example, in one embodiment, the flow rate loaded into the data model is then used to calculate slopes of the curve at various points during urination to determine if the detrusor or other features of the bladder are excreting at an extremely high rate. A system to define the slope (acceleration of the initial void to the maximal flow velocity includes or initial acceleration) can be used to define these diagnostic categories especially when combined with the ability to measure the area under the curve.).
As McMahon discloses that work-related data may correspond to the health of a lumen and Franco discloses that work data may be used to assess a lumen as being over- or under-active, it would have been obvious to one having ordinary skill in the art at the time of filing to modify the method of McMahon to utilize the teachings of Franco to compute, with the computer system, muscular work data to provide a health assessment of the lumen in order to predictably improve the method by monitoring not just a general state of the lumen but also determining whether this state corresponds to a healthy or unhealthy lumen which may prompt further diagnostic investigation or treatments.
Regarding claim 2, the combination of McMahon and Franco teaches the method of claim 1. McMahon additionally teaches wherein the reduced order model comprises a one-dimensional fluid mechanics-based model (paragraph 0102-0104-- Calculations of flow through the LOS during swallowing can also be made when the probe is in situ in the sphincter. The patient performs both water and air swallows and the CSA and pressure readings are recorded for the relaxation of the LOS as a result of the swallows. Using Newton's law of motion applied to force, rates for air and water in both the control and patient groups can be estimated using the following equation Q =.DELTA.P* D4/CVL where Q=flow rate, .DELTA.P=Pressure Difference, D=Diameter, C=Constant, V=Viscosity, L=length).
Regarding claim 3, the combination of McMahon and Franco teaches the method of claim 1. McMahon additionally teaches wherein the reduced order model incorporates effects of a nonlinear relationship between pressure and area on a value of work done during peristalsis (paragraph 0026, 0032-0035, 0038-0041-- The distension can be used to derive pressure-cross sectional area (CSA) and pressure-diameter diagrams with subsequent evaluation of the circumferential wall tension, force of closure, strain, compliance and flow characteristics. In relation to the wall tension, it is the active, passive and total forces inducing tension and stress, which is derived. This length-tension test provides data on the passive nature of the tissue, on the maximum force generated by the smooth muscle, and the strain corresponding to the maximum force; paragraph 0102-0104-- Calculations of flow through the LOS during swallowing can also be made when the probe is in situ in the sphincter. The patient performs both water and air swallows and the CSA and pressure readings are recorded for the relaxation of the LOS as a result of the swallows. Using Newton's law of motion applied to force, rates for air and water in both the control and patient groups can be estimated using the following equation Q =.DELTA.P* D4/CVL where Q=flow rate, .DELTA.P=Pressure Difference, D=Diameter, C=Constant, V=Viscosity, L=length).
Regarding claim 4, the combination of McMahon and Franco teaches the method of claim 1. McMahon additionally teaches wherein the reduced order model is constructed to model peristaltic activation waves to have a non-constant velocity (paragraph 0026, 0032-0035, 0038-0041-- The distension can be used to derive pressure-cross sectional area (CSA) and pressure-diameter diagrams with subsequent evaluation of the circumferential wall tension, force of closure, strain, compliance and flow characteristics. In relation to the wall tension, it is the active, passive and total forces inducing tension and stress, which is derived. This length-tension test provides data on the passive nature of the tissue, on the maximum force generated by the smooth muscle, and the strain corresponding to the maximum force; paragraph 0102-0104-- Calculations of flow through the LOS during swallowing can also be made when the probe is in situ in the sphincter. The patient performs both water and air swallows and the CSA and pressure readings are recorded for the relaxation of the LOS as a result of the swallows. Using Newton's law of motion applied to force, rates for air and water in both the control and patient groups can be estimated using the following equation Q =.DELTA.P* D4/CVL where Q=flow rate, .DELTA.P=Pressure Difference, D=Diameter, C=Constant, V=Viscosity, L=length).
Regarding claim 6, the combination of McMahon and Franco teaches the method of claim 1. McMahon additionally teaches wherein the flow data comprise pressure field data indicative of pressure values along an extent of the planimetry catheter (Paragraph 0026, 0041, 0043, 0071-0075--The distension can be used to derive pressure-cross sectional area (CSA) and pressure-diameter diagrams…force-deformation diagrams such as length-tension diagrams, pressure-CSA diagrams, pressure-diameter diagrams, tension-strain diagrams, stress-strain diagrams and pressure-geometry data such as wall thickness, lumen size and safe under various conditions such as during administration of drugs in animals or persons with diseases).
Regarding claim 9, the combination of McMahon and Franco teaches the method of claim 1. McMahon additionally teaches wherein one of the plurality of different regimes each indicate different patterns of peristaltic pumping that are defined based on a response of the wall of the lumen and fluid within the lumen to an applied activation (Paragraph 0011, 0023-0026, 044-0047, 0102--applying stimuli to sphincters in the GI tract and to simultaneously measure physical properties of the apparatus applying the stimuli, which are representative of the response of the stimulated sphincter…it is possible to make multiple cross-sectional area or diameter measurements in an axial direction such that a three-dimensional profile of the balloon can be obtained and analysed with respect to geometry and mechanical parameters… Development of balloon distension protocols is useful in order to correlate biomechanics, motor control, sensation and the valvular action of the LOS, in particular in the gastrointestinal tract in vivo and in vitro. The distension can be used to derive pressure-cross sectional area (CSA) and pressure-diameter diagrams with subsequent evaluation of the circumferential wall tension, force of closure, strain, compliance and flow characteristics… Signal analysis from the apparatus may include reconstruction of three dimensional geometry…; paragraph 0064-- data on pressure inside the balloon, pressure at the distal end of the catheter, pressure at the proximal end of the catheter and multiple cross sectional areas (CSAs) inside the balloon may be recorded on a personal computer and then they can be used to construct a 3 dimensional geometric surface profile of the sphincter).
Regarding claim 10, the combination of McMahon and Franco teaches the method of claim 1. McMahon additionally teaches wherein the planimetry data comprise measurements of geometry along an extent of a balloon of the planimetry catheter (Paragraph 0032-0035, 0037, 0086-0088-- measurements of geometry, including surface geometry… measuring lumen diameters, multiple cross-sectional areas along the length of the balloon, circumferences, the contour, the three-dimensional geometry or the wall thickness of the region of interest with or without the balloon pressure).
Regarding claim 11, the combination of McMahon and Franco teaches the method of claim 1. McMahon additionally teaches wherein the planimetry data comprise measurements of area along an extent of a balloon of the planimetry catheter (Paragraph 0037, 0043-0046, 0071-- measuring lumen diameters, multiple cross-sectional areas along the length of the balloon, circumferences, the contour, the three-dimensional geometry or the wall thickness of the region of interest with or without the balloon pressure).
Regarding claim 12, the combination of McMahon and Franco teaches the method of claim 1. McMahon additionally teaches wherein the planimetry data comprise measurements of at least one of internal diameter, cross-section, or distensibility of the lumen into which the planimetry catheter has been positioned (Paragraph 0027, 0031-0035, 0043-0046, 0071-0072, 0078, 0089-- force-deformation properties such as compliance, distensibility parameters, length-tension diagrams, tension-strain diagrams, and stress-strain diagrams …measuring lumen diameters, multiple cross-sectional areas along the length of the balloon, circumferences, the contour, the three-dimensional geometry or the wall thickness of the region of interest with or without the balloon pressure…).
Regarding claim 13, the combination of McMahon and Franco teaches the method of claim 1. McMahon additionally teaches wherein the pressure data are measured at a point along an extent of the planimetry catheter (Paragraph 0064-- While the balloon is inflated data on pressure inside the balloon, pressure at the distal end of the catheter, pressure at the proximal end of the catheter and multiple cross sectional areas (CSAs) inside the balloon may be recorded on a personal computer and then they can be used to construct a 3 dimensional geometric surface profile of the sphincter; paragraph 0026, 0041, 0043, 0071-0075-- pressure-cross sectional area (CSA) and pressure-diameter diagrams with subsequent evaluation of the circumferential wall tension, force of closure, strain, compliance and flow characteristics… from the measurements deriving force-deformation diagrams such as length-tension diagrams, pressure-CSA diagrams, pressure-diameter diagrams, tension-strain diagrams, stress-strain diagrams and pressure-geometry data such as wall thickness, lumen size…; paragraph 0006-0007-- detect the pressure at a certain distance from the oral or nasal opening and in a certain radial orientations… As the pressure sensors reach the LOS in a normal subject there will be a pressure increase indicating the tensioned area of the LOS).
Regarding claim 14, the combination of McMahon and Franco teaches the method of claim 1. McMahon additionally teaches wherein the point is adjacent a tip of the planimetry catheter (Paragraph 0064-- While the balloon is inflated data on pressure inside the balloon, pressure at the distal end of the catheter, pressure at the proximal end of the catheter and multiple cross sectional areas (CSAs) inside the balloon may be recorded on a personal computer and then they can be used to construct a 3 dimensional geometric surface profile of the sphincter; paragraph 0026, 0041, 0043, 0071-0075-- pressure-cross sectional area (CSA) and pressure-diameter diagrams with subsequent evaluation of the circumferential wall tension, force of closure, strain, compliance and flow characteristics… from the measurements deriving force-deformation diagrams such as length-tension diagrams, pressure-CSA diagrams, pressure-diameter diagrams, tension-strain diagrams, stress-strain diagrams and pressure-geometry data such as wall thickness, lumen size…; paragraph 0006-0007-- detect the pressure at a certain distance from the oral or nasal opening and in a certain radial orientations… As the pressure sensors reach the LOS in a normal subject there will be a pressure increase indicating the tensioned area of the LOS).
Regarding claim 15, the combination of McMahon and Franco teaches the method of claim 1. McMahon additionally teaches wherein the pressure data are measured at multiple points along an extent of the planimetry catheter (Paragraph 0064-- While the balloon is inflated data on pressure inside the balloon, pressure at the distal end of the catheter, pressure at the proximal end of the catheter and multiple cross sectional areas (CSAs) inside the balloon may be recorded on a personal computer and then they can be used to construct a 3 dimensional geometric surface profile of the sphincter; paragraph 0026, 0041, 0043, 0071-0075-- pressure-cross sectional area (CSA) and pressure-diameter diagrams with subsequent evaluation of the circumferential wall tension, force of closure, strain, compliance and flow characteristics… from the measurements deriving force-deformation diagrams such as length-tension diagrams, pressure-CSA diagrams, pressure-diameter diagrams, tension-strain diagrams, stress-strain diagrams and pressure-geometry data such as wall thickness, lumen size…; paragraph 0006-0007-- detect the pressure at a certain distance from the oral or nasal opening and in a certain radial orientations… As the pressure sensors reach the LOS in a normal subject there will be a pressure increase indicating the tensioned area of the LOS).
Regarding claim 17, the combination of McMahon and Franco teaches the method of claim 1. McMahon additionally teaches performing volume correction on at least one of the planimetry data or the pressure data using a bag volume of the planimetry catheter as a basis for the volume correction (Paragraph 0026, 0031, 0041, 0043, 0062, 0066, 0071-0075, 0078-- the denomination "balloon" will be used, because this is the commonly used denomination, although the balloon may be as a bag…enable the use of a catheter that has slim and smooth properties so as to minimise the discomfort to patients when it is inserted into any of the body openings where hollow organs can be accessed, all the while ensuring that the balloon contained within it can be re-inflated for the purpose of stimulation and measurement with the minimum amount of error being introduced by the mechanical properties of the balloon…The pressure of the fluid is monitored, possibly by a pressure gauge inside the balloon. Alternatively to measuring the pressure, the volume of the fluid being pumped may be monitored, either when being pumped to the balloon or after having been pumped to the balloon. The inflation of the balloon constitutes a mechanical stimulus of the sphincter or of a hollow organ restriction in the area under investigation.).
Claim(s) 5 and 7-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over McMahon in view of Franco, further in view of Gregersen (US 20090062684 A1).
Regarding claim 5, the combination of McMahon and Franco teaches the method of claim 1. However, McMahon does not explicitly disclose wherein the flow data comprise fluid velocity data indicative of fluid velocity values along an extent of the planimetry catheter. Gregersen, in analogous art of medical measurement systems for evaluation of organ function including lumen properties, discloses inputting the planimetry data and the pressure data to a reduced order model using the computer system, generating output as flow data (Paragraph 0124-0126— calculations of flow through the organ can also be made when the probe is in situ…CSA and pressure are recorded…equation 8: Using Newton's law of motion applied to force, rates for air and water in both the control and patient groups can be estimated using the following equation; Q =.DELTA.P* D4/CVL where Q=flow rate, .DELTA.P=Pressure Difference, D=Diameter, C=Constant, V=Viscosity, L=length…these equations together with the measurement of the volume passing a given point using the impedance technique, various unknowns such as the viscosity can be determined; paragraph 0057-0058—determination of fluid conductivity…viscosity measurements; paragraph 0107-0110—different volumes of gas are swallowed in order to determine parameters such as parallel conductance…conductivity of saliva can be measured…the CSA and volume data are used in further analysis of flow, volume loops, max flow-volume loops, isovolumteric pressure-flow (IVPF), flow-pressure loops, tension diagrams including active-passive tensions based on pharmacological modulation of organ function, mechanical parameters such as tension-strain, stress-strain relations, velocity curves and other muscle function and elasticity diagrams),
wherein the flow data comprise fluid velocity data indicative of fluid velocity values along an extent of the planimetry catheter (Paragraph 0006, 0027, 0077--By measuring multiple cross-sectional areas it is possible to determine the 3D geometry of the lumen and by using time delays and changes in cross-sectional areas it is possible to measure velocity of bolus transport; Paragraph 0077, 0104-0110—different volumes of gas are swallowed in order to determine parameters such as parallel conductance…conductivity of saliva can be measured…the CSA and volume data are used in further analysis of flow, volume loops, max flow-volume loops, isovolumteric pressure-flow (IVPF), flow-pressure loops, tension diagrams including active-passive tensions based on pharmacological modulation of organ function, mechanical parameters such as tension-strain, stress-strain relations, velocity curves and other muscle function and elasticity diagrams; Paragraph 0124-0126— calculations of flow through the organ can also be made when the probe is in situ…CSA and pressure are recorded…equation 8: Using Newton's law of motion applied to force, rates for air and water in both the control and patient groups can be estimated using the following equation; Q =.DELTA.P* D4/CVL where Q=flow rate, .DELTA.P=Pressure Difference, D=Diameter, C=Constant, V=Viscosity, L=length…these equations together with the measurement of the volume passing a given point using the impedance technique, various unknowns such as the viscosity can be determined). It would have been obvious to one having ordinary skill in the art at the time of filing to modify the system of McMahon to utilize flow data as taught by Gregersen because the modification would allow the system to predictably make additional determinations related to lumen health and physiology, thus improving the usability of the device in different diagnostic cases.
Regarding claim 7, the combination of McMahon and Franco teaches the method of claim 1. McMahon additionally teaches wherein the flow data comprises pressure field data indicative of pressure values along an extent of the planimetry catheter. However, McMahon fails to disclose the flow data comprise fluid velocity data indicative of fluid velocity values along an extent of the planimetry catheter (Paragraph 0026, 0041, 0043, 0071-0075--The distension can be used to derive pressure-cross sectional area (CSA) and pressure-diameter diagrams…force-deformation diagrams such as length-tension diagrams, pressure-CSA diagrams, pressure-diameter diagrams, tension-strain diagrams, stress-strain diagrams and pressure-geometry data such as wall thickness, lumen size and safe under various conditions such as during administration of drugs in animals or persons with diseases). Gregersen teaches wherein the flow data comprise both pressure field data indicative of pressure values along an extent of the planimetry catheter and fluid velocity data indicative of fluid velocity values along an extent of the planimetry catheter (Paragraph 0053, 0063, 0077; Paragraph 0107-0110—different volumes of gas are swallowed in order to determine parameters such as parallel conductance…conductivity of saliva can be measured…the CSA and volume data are used in further analysis of flow, volume loops, max flow-volume loops, isovolumteric pressure-flow (IVPF), flow-pressure loops, tension diagrams including active-passive tensions based on pharmacological modulation of organ function, mechanical parameters such as tension-strain, stress-strain relations, velocity curves and other muscle function and elasticity diagrams; Paragraph 0124-0126— calculations of flow through the organ can also be made when the probe is in situ…CSA and pressure are recorded…equation 8: Using Newton's law of motion applied to force, rates for air and water in both the control and patient groups can be estimated using the following equation; Q =.DELTA.P* D4/CVL where Q=flow rate, .DELTA.P=Pressure Difference, D=Diameter, C=Constant, V=Viscosity, L=length…these equations together with the measurement of the volume passing a given point using the impedance technique, various unknowns such as the viscosity can be determined). It would have been obvious to one having ordinary skill in the art at the time of filing to modify the system of McMahon to utilize flow data comprising both pressure field data and fluid velocity data as taught by Gregersen because the modification would allow the system to predictably make additional determinations related to lumen health and physiology, thus improving the usability of the device in different diagnostic cases.
Regarding claim 8, the combination of McMahon, Franco, and Gregersen teaches the method of claim 7. McMahon additionally teaches wherein the planimetry data and pressure data are acquired while the planimetry catheter has been positioned within a tubular organ, and further comprising generating with the computer system, muscular work data from the pressure field data and the fluid velocity data, wherein the muscular work data quantify work done by a muscle associated with the tubular organ (Paragraph 0026, 0038-0041--distension can be used to derive pressure-cross sectional area (CSA) and pressure-diameter diagrams with subsequent evaluation of the circumferential wall tension, force of closure, strain, compliance and flow characteristics. In relation to the wall tension, it is the active, passive and total forces inducing tension and stress, which is derived. This length-tension test provides data on the passive nature of the tissue, on the maximum force generated by the smooth muscle, and the strain corresponding to the maximum force)
Gregersen additionally teaches wherein the planimetry data and pressure data are acquired while the planimetry catheter has been positioned within a tubular organ, and further comprising generating with the computer system, muscular work data from the pressure field data and the fluid velocity data, wherein the muscular work data quantify work done by a muscle associated with the tubular organ (Paragraph 0026-0027, 0053, 0063, 0077--measuring the conductivity of the fluid in the lumen it is possible to determine exact changes in the parallel conductance and thereby to obtain important information on the wall properties; Paragraph 0107-0110—different volumes of gas are swallowed in order to determine parameters such as parallel conductance…conductivity of saliva can be measured…the CSA and volume data are used in further analysis of flow, volume loops, max flow-volume loops, isovolumteric pressure-flow (IVPF), flow-pressure loops, tension diagrams including active-passive tensions based on pharmacological modulation of organ function, mechanical parameters such as tension-strain, stress-strain relations, velocity curves and other muscle function and elasticity diagrams; Paragraph 0124-0126— calculations of flow through the organ can also be made when the probe is in situ…CSA and pressure are recorded…equation 8: Using Newton's law of motion applied to force, rates for air and water in both the control and patient groups can be estimated using the following equation; Q =.DELTA.P* D4/CVL where Q=flow rate, .DELTA.P=Pressure Difference, D=Diameter, C=Constant, V=Viscosity, L=length…these equations together with the measurement of the volume passing a given point using the impedance technique, various unknowns such as the viscosity can be determined; paragraph 0114-0115—resistance load parameter can be computer…impedance and conductance measurements are used in characterizing body sphincters…).
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over McMahon in view of Franco, further in view of Pandolfino (US 20180008156 A1).
Regarding claim 16, the combination of McMahon and Franco teaches the method of claim 1. However, McMahon fails to explicitly disclose increasing a sampling density of at least one of the planimetry data or the pressure data by interpolating the at least one of the planimetry data or the pressure data to the sampling density. Pandolfino, in analogous art of a system for obtaining measurements of a lumen (Paragraph 0027), teaches increasing a sampling density of at least one of the planimetry data or the pressure data by interpolating the at least one of the planimetry data or the pressure data to the sampling density (Paragraph 0053-- Tracings of each channel's measured luminal diameter can be electronically generated with corresponding volume distension and intra-bag pressure by time…topography plot of the interpolated luminal diameters can also be electronically generated…). It would have been obvious to one having ordinary skill in the art at the time of filing to modify the system of McMahon to increase a sampling density by interpolating the data as taught by Pandolfino in order to predictably improve the volume of output flow data by providing additional samples.
Response to Arguments
Applicant's arguments filed 16 December 2025 regarding the rejection of the claims under 35 U.S.C. 101 have been fully considered but they are not persuasive.
The applicant argues that the claimed invention recites an improvement to current balloon dilation catheter technology such that any abstract idea is integrated into a practical application and further argues that the recitation of the planimetry catheter demonstrates the use of a particular machine that is integral to the claim.
However, the current claim language only reflects “enabling the measurement and reporting of quantities (e.g., pressure field, fluid velocity, muscular work” in the form of a judicial exception, namely a mental process or mathematical calculation as described above. While the abstract idea itself may be an improvement over the existing technology, per Genetic Technologies Limited v. Merial LLC (Fed Cir., 2016) the inventive concept of step 2 of the Alice/Mayo analysis cannot be supplied by the abstract idea. The inventive concept necessary at step two of the Mayo/Alice analysis cannot be furnished by the unpatentable abstract idea itself. That is, under the Mayo/Alice framework, a claim directed to a newly discovered abstract idea cannot rely on the novelty of that discovery for the inventive concept necessary for patent eligibility; instead, the application must provide something inventive, beyond mere “well-understood, routine, conventional activity.” Mayo, 132 S. Ct. at 1294; see also Myriad, 133 S. Ct. at 2117; Ariosa, 788 F.3d at 1379. For this reason, the abstract limitations may not be seen as an improvement which integrates the judicial exception into a practical application.
Furthermore, the applicant’s specification and arguments (page 6 of remarks) describe that planimetry and pressure data are acquired with a balloon dilation catheter, such that the catheter itself is not improved nor is it a particular machine which includes improvements over existing technology, and any improvement is limited to the processing of the data in the steps identified as judicial exceptions. The recitation of the planimetry catheter of claim 1 is additionally extra-solution activity which contributes to the claimed method insignificantly in a data gathering step as the purported improvement and inventive concept are directed to the processing of data, where the gathering of data is merely performed to provide input for the processing steps which have been identified as abstract. See MPEP 2106.05(b)(I-III) which notes that it has been held that “mere ‘[data-gathering] step[s] cannot make an otherwise nonstatutory claim statutory.’" 654 F.3d at 1375, 99 USPQ2d at 1694”.
Applicant's arguments filed 16 December regarding the rejection of the claims under 35 U.S.C. 102/103 have been fully considered but they are not persuasive.
While the applicant argues that McMahon fails to disclose the newly amended step (e) as claimed, the examiner notes that the broadest reasonable interpretation of the claim limitations is disclosed by McMahon as described above in this action. Although the applicant argues that “McMahon does not teach any classification system, regime categorization, or method for organizing data into distinct regimes based on deformation patterns”, it may be seen that McMahon discloses determining mechanical parameters of a lumen such as flow and determining a 3D profile of a lumen based on these parameters, such that the parameters themselves are effectively classified into regimes corresponding to narrower or wider 3D geometry which is based on deformation patterns.
Franco additionally provides some disclosure (noted above) which under the broadest reasonable interpretation of the claim language may be considered classifying data into different regimes to form a regime map.
The claims remain rejected under 35 U.S.C. 103.
Conclusion
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/ANNA ROBERTS/Examiner, Art Unit 3791