Detailed Notice
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 .
Status of Claims
Claims 1-20 are currently pending.
Claims 1, 4-5, 12-15, and 19-20 are amended.
Claims 1-20 are rejected.
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.
Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Step 1:
In the instant case, claims 1-14 are directed toward a vascular therapy apparatus (i.e., machine), claims 15-19 are directed toward a vascular therapy method (i.e., machine), and claim 20 is directed toward a balloon angioplasty system (i.e., machine). Thus, each of the claims falls within one of the four statutory categories. Nevertheless, the claims fall within the judicial exception of an abstract idea.
Step 2A—Prong 1:
Independent claims 1, 15, and 20 recites steps that, under their broadest reasonable interpretations, cover performance of the limitations of a certain method of organizing human activity but for the recitation of generic computer components.
Claim 1 recites: “A vascular therapy apparatus, comprising: an electronic processing device comprising at least one electronic processor programmed to: while an angioplasty procedure is performed on a treatment site in a vessel (V) of a patient, obtain data about the angioplasty procedure; determine treatment information for a subsequent vascular therapy treatment of the treatment site by analyzing the data about the angioplasty procedure, the treatment information comprising selection of a vascular therapy device for use in the subsequent vascular therapy; and output the treatment information for performing the subsequent vascular therapy using the vascular therapy device”.
The limitations of while an angioplasty procedure is performed on a treatment site in a vessel (V) of a patient, obtain data about the angioplasty procedure; determine treatment information for a subsequent vascular therapy treatment of the treatment site by analyzing the data about the angioplasty procedure, the treatment information comprising selection… for use in the subsequent vascular therapy; and output the treatment information for performing the subsequent vascular therapy, given the broadest reasonable interpretation, cover the abstract idea of a certain method of organizing human activity because they recite managing personal behavior or relationships or interactions between people (i.e. social activities, teaching, and following rules or instructions—in this case the aforementioned steps recite a process of obtaining, determine, analyzing, and output, which is properly interpreted as a “personal behavior”), but instead automates the process via a computer model, e.g. see MPEP 2106.04(a)(2). Any limitations not identified above as part of the abstract idea are deemed “additional elements”, and will be discussed in further detail below.
Additionally, claim 15 recites: “A vascular therapy method comprising: performing an angioplasty procedure by expanding a balloon at a treatment site in a vessel (V) of a patient; while performing the angioplasty procedure, obtaining data about the angioplasty procedure; analyzing the data about the angioplasty procedure using an electronic processor to determine treatment information for a subsequent vascular therapy treatment of the treatment site, the treatment information comprising selection of a vascular therapy device for use in the subsequent vascular therapy; and performing the subsequent vascular therapy treatment of the treatment site using the vascular therapy device”.
The limitations of performing an angioplasty procedure by expanding a balloon at a treatment site in a vessel (V) of a patient; while performing the angioplasty procedure, obtaining data about the angioplasty procedure; analyzing the data about the angioplasty procedure… to determine treatment information for a subsequent vascular therapy treatment of the treatment site, the treatment information comprising selection… for use in the subsequent vascular therapy; and performing the subsequent vascular therapy treatment of the treatment site, given the broadest reasonable interpretation, cover the abstract idea of a certain method of organizing human activity because they recite managing personal behavior or relationships or interactions between people (i.e. social activities, teaching, and following rules or instructions—in this case the aforementioned steps recite a process of performing, obtaining, determining, selection, and performing, which is properly interpreted as a “personal behavior”), but instead automates the process via a computer model or machine learning), e.g. see MPEP 2106.04(a)(2). Any limitations not identified above as part of the abstract idea are deemed “additional elements”, and will be discussed in further detail below.
Additionally, claim 20 recites: “A balloon angioplasty system, comprising: a catheter; an expandible balloon disposed at a distal end of the catheter; a sensor disposed inside the balloon and configured to measure data about an angioplasty procedure performed at a treatment site using the catheter; and at least one electronic processor programmed to: obtain the measured data during the angioplasty procedure; retrieve a digital twin of the treatment site from a database; and determine treatment information applied to a subsequent vascular therapy treatment of the treatment site using the retrieved digital twin”.
The limitations of obtain the measured data during the angioplasty procedure; retrieve a digital twin of the treatment site; and determine treatment information applied to a subsequent vascular therapy treatment of the treatment site, given the broadest reasonable interpretation, cover the abstract idea of a certain method of organizing human activity because they recite managing personal behavior or relationships or interactions between people (i.e. social activities, teaching, and following rules or instructions—in this case the aforementioned steps recite a process of obtain, retrieve, and determine, which is properly interpreted as a “personal behavior”), but instead automates the process via a computer model or machine learning), e.g. see MPEP 2106.04(a)(2). Any limitations not identified above as part of the abstract idea are deemed “additional elements”, and will be discussed in further detail below.
Dependent claims 2-14 and 16-19 include other limitations, as well as specific step of data to be processed, received, and applied, but these only serve to further limit the abstract idea and do not add and additional elements, and hence are nonetheless directed towards fundamentally the same abstract idea as independent claims 1, 15, and 20. However, recitation of an abstract idea is not the end of the 35 U.S.C. 101 analysis. Each of the claims must be analyzed for additional elements that indicate the abstract idea is integrated into a practical application to determine whether the claim is considered to be “directed to” an abstract idea.
Step 2A—Prong 2:
Claims 1-20 are not integrated into a practical application because the additional elements (i.e. any limitations that are not identified as part of the abstract idea) amount to no more than limitations which:
Amount to mere instructions to apply an exception—for example, the recitation of “electronic processing device”, “electronic processor”, “vascular therapy device”, “catheter”, “sensor”, “balloon”, “database”, and “digital twin”, which amount to merely invoking a computer as a tool to perform the abstract idea, e.g. see [0025], [0028]-[0029], and [0036], of the present specification, and see further MPEP 2106.05(f);
Generally linking the abstract idea to a particular technological environment or field of use, for example, “an electronic processing device comprising at least one electronic processor programmed to”, “of a vascular therapy device”, “using the vascular therapy device”, “using an electronic processor”, “a catheter; an expandible balloon disposed at a distal end of the catheter; a sensor disposed inside the balloon and configured to measure data about an angioplasty procedure performed at a treatment site using the catheter; and at least one electronic processor programmed to”, “from a database”, and “using the retrieved digital twin”, which amounts to limiting the abstract idea to the field of technology/the environment of computers, see MPEP 2106.05(h); and/or
Merely acquiring information for further analysis by the system and the particular manner of acquisition is not described or shown to be important, for example, “obtain data about the angioplasty procedure” and “obtain the measured data during the angioplasty procedure; retrieve a digital twin of the treatment site from a database”, which amounts to insignificant extra-solution activity in the form of mere data gathering because it merely functions tangentially to the main idea of the invention and serves only to bring in the data necessary for the inventions main analysis, see MPEP 2106.05(g).
Additionally, dependent claims 2-14 and 16-19 include other limitations, but as stated above, the limitations recited by these claims do not include any additional elements beyond those already recited in independent claims 1, 15, and 20, and hence also do not integrate the aforementioned abstract idea into a practical application.
Step 2B:
The claims do not include additional elements (i.e., “electronic processing device”, “electronic processor”, “vascular therapy device”, “catheter”, “sensor”, “balloon”, “database”, and “digital twin”) that are sufficient to amount to “significantly more” than the judicial exception because the additional elements (i.e. the elements other than the abstract idea), as stated above, are directed towards no more than limitations that amount to mere instructions to apply the exception, and/or generally link the abstract idea to a particular technological environment or field of use, which even when reevaluated under the considerations of Step 2B of the analysis, do not amount to “significantly more” than the abstract idea.
Dependent claims 2-14 and 16-20 include other limitations, but none of these limitations are deemed significantly more than the abstract idea because, as stated above, the aforementioned dependent claims do not recite any additional elements not already recited in independent claims 1, 15, and 20, and hence do not amount to “significantly more” than the abstract idea.
Additionally, the additional elements (i.e., “obtain data about the angioplasty procedure” and “obtain the measured data during the angioplasty procedure; retrieve a digital twin of the treatment site from a database”), add extra solution activity, which comprises limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in a particular field as demonstrated by:
Relevant court decisions (See MPEP 2106.05(d)(II)):
Receiving or transmitting data over a network, e.g., using the Internet to gather data, Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information); TLI Communications LLC v. AV Auto. LLC, 823 F.3d 607, 610, 118 USPQ2d 1744, 1745 (Fed. Cir. 2016) (using a telephone for image transmission); OIP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015) (sending messages over a network); buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and sends information over a network); but see DDR Holdings, LLC v. Hotels.com, L.P., 773 F.3d 1245, 1258, 113 USPQ2d 1097, 1106 (Fed. Cir. 2014) (“Unlike the claims in Ultramercial, the claims at issue here specify how interactions with the Internet are manipulated to yield a desired result‐‐a result that overrides the routine and conventional sequence of events ordinarily triggered by the click of a hyperlink.” (emphasis added)).
Thus, taken alone, the additional elements do not amount to significantly more than the abstract idea identified above. Furthermore, looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually, and there is no indication that the combination of elements improves the functioning of a computer or improves any other technology, and their collective functions merely provide conventional computer implementation.
Therefore, whether taken individually or as an ordered combination, claims 1-20 are nonetheless rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
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) 1-19 are rejected under 35 U.S.C. 103 as being unpatentable over Hunter et al. (WO 2016044651 A1), hereinafter Hunter, in view of Grace et al. (US 20160184570 A1), hereinafter Grace.
Regarding claim 1 Hunter teaches a vascular therapy apparatus (Hunter, Abstract), comprising: an electronic processing device comprising at least one electronic processor programmed to (Hunter, [0093] and [0122]: “remote data-receiving device 82 may be, or include, a smart phone or tablet computer having circuitry sufficient to receive, demodulate, and recover sensor data from the wireless signal that the sensor module 10 transmits via the antenna 22. And the device 82 may also be configured to analyze, or otherwise process, the recovered sensor data”): while an angioplasty procedure is performed on a treatment site in a vessel (V) of a patient (Hunter, [0253]: “the implementation of a medical or surgical procedure or device [e.g. , coronary angioplasty, peripheral angioplasty, angiography, dilation of an artery and/or placement of a stent, balloon septostomy, balloon sinuplasty, catheter-based ablation, balloon dilation catheters (esophageal, biliary, tracheal, bronchial, urethral, etc.)]”), obtain data about the angioplasty procedure (Hunter, [0256]: “Figure 18 illustrates a balloon catheter having one or more ISMs containing a variety of sensors positioned in or on the balloon catheter (and/or potentially the guidewire) in order to monitor, in situ, the real-time operation of the catheter, the inflation and deflation of the balloon, the forces exerted by the balloon against adjacent tissues or devices {e.g. stents), flow levels through and around the balloon, and the catheter performance acutely and over time… While in certain embodiments, ISMs containing contact sensors, pressure sensors, and positions sensors can be utilized as shown in Figure 18, a wide variety of other sensors can also be used within the ISM that is placed in, on, or within the balloon catheter, including for example, fluid pressure sensors, accelerometers, vibration sensors, pulse sensors, liquid {e.g. , blood) volume sensors, liquid {e.g. , blood) flow sensors, liquid {e.g. , blood) chemistry sensors, liquid {e.g. , blood) metabolic sensors, mechanical stress sensors, and temperature sensors”); determine treatment information for a subsequent vascular therapy treatment of the treatment site by analyzing the data about the angioplasty procedure (Hunter, [0257], [0273]: “Many of these parameters are important in the monitoring the need, effectiveness, timing and frequency of dialysis treatments and would be a great assistance to the clinician managing a renal patient; similarly comparing values in the arterial arm of the catheter, the venous arm of the catheter and the systemic circulation would also provide useful clinical data”, and [0374]).
Hunter does not teach the treatment information comprising selection of a vascular therapy device for use in the subsequent vascular therapy and output the treatment information for performing the subsequent vascular therapy using the vascular therapy device.
However, Grace teaches the treatment information comprising selection of a vascular therapy device for use in the subsequent vascular therapy (Grace, [0005], [0122]-[0123]: “The present disclosure relates generally to the use of medical devices for the treatment of vascular conditions. In particular, the present disclosure provides materials and methods for using electrode-induced pressure waves to disrupt vascular blockages and to deliver therapeutic agents to the blockage area”, [0129-0140]: “There may be any number of electrode assemblies located at the distal end of the catheter and enclosed by the balloon” with alternate versions of the balloon-catheter system and different polymers for use therein and [0155] {the examiner asserts that each version of the balloon-catheter system being its own therapy device}) and output the treatment information for performing the subsequent vascular therapy using the vascular therapy device (Grace, FIG. 9, [0005], [0066], [0122]-[0123]: “The present disclosure relates generally to the use of medical devices for the treatment of vascular conditions. In particular, the present disclosure provides materials and methods for using electrode-induced pressure waves to disrupt vascular blockages and to deliver therapeutic agents to the blockage area”, [0150]-[0151], and [0161]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify Hunter to incorporate the teachings of Grace and account for improving therapeutic outcomes for people suffering from coronary artery disease and peripheral artery disease improve therapeutic outcomes for people suffering from CAD and PAD (Grace, Abstract and [0003]-[0006]).
Regarding claim 2 Hunter further teaches the electronic processor is programmed to determine the treatment information by operations including (Hunter, [0257], [0273]: “Many of these parameters are important in the monitoring the need, effectiveness, timing and frequency of dialysis treatments and would be a great assistance to the clinician managing a renal patient; similarly comparing values in the arterial arm of the catheter, the venous arm of the catheter and the systemic circulation would also provide useful clinical data”, and [0374]): retrieving a digital twin of the treatment site from a database (Hunter, [0588] and [0590]); and determining the treatment information by analyzing the data about the angioplasty procedure using the retrieved digital twin (Hunter, [0256]-[0257], [0273]: “Many of these parameters are important in the monitoring the need, effectiveness, timing and frequency of dialysis treatments and would be a great assistance to the clinician managing a renal patient; similarly comparing values in the arterial arm of the catheter, the venous arm of the catheter and the systemic circulation would also provide useful clinical data”, and [0374]).
Regarding claim 3 Hunter further teaches the digital twin is configured to determine data related to tissue compliance of a stenosis and surrounding tissue at the treatment site (Hunter, [0168], [0188], and [0514]).
Regarding claim 4 Hunter further teaches the obtained data about the angioplasty procedure includes one or more of inflation pressure of an associated balloon used in the angioplasty procedure, inflation volume of the associated balloon used in the angioplasty procedure, and/or imaging data of the treatment site obtained before, during and/or after the angioplasty procedure (Hunter, [0194], [0256]-[0259], [0273]: “Many of these parameters are important in the monitoring the need, effectiveness, timing and frequency of dialysis treatments and would be a great assistance to the clinician managing a renal patient; similarly comparing values in the arterial arm of the catheter, the venous arm of the catheter and the systemic circulation would also provide useful clinical data”, [0310]-[0311], and [0374]).
Regarding claim 5 Hunter further teaches the vascular therapy device comprises a self-expanding vascular therapy device, and wherein the selection of the associated vascular therapy device includes selection of at least one of a stiffness of the self-expanding vascular therapy device to be used in the subsequent vascular therapy treatment and a diameter of the self-expanding vascular therapy device to be used in the subsequent vascular therapy treatment, and a length of the self-expanding vascular therapy device to be used in the subsequent vascular therapy treatment (Hunter, [0186]: “Most often the stent is delivered to the deployment site in a compressed form and then expanded into place (often by inflating a balloon with the stent or through the use of "self-expanding" stents) to open the organ lumen back up to its original size and shape”, [0194]: “if it is correctly implanted anatomically, if the stent is appropriately sized for the vessel in which it is placed, if it is completely opened (deployed) during balloon expansion (or during self-expansion), if it exerts too much (or too little) pressure against the vessel wall, if stent segments are correctly assembled, if there is an optimal amount of overlap between adjacent stents, if there is kinking or deformation of the stent, if there is cracking or fracturing of the stent, and if there is uniform flow through the device - to name but a few important functions. Stents of the present invention can allow the operating physician to monitor many valuable parameters that can lead to better and less traumatic stent placement and deployment”, [0217], and [0505]: “In addition to heart valves, delivery devices are also provided. In the context of percutaneous heart valve delivery, particularly preferred delivery devices comprise a guidewire, delivery catheter, catheters with a "sheath" that deploy self-expanding devices, catheters with an expandable balloon, and anchoring suture devices”)
Regarding claim 6 Hunter further teaches the obtained data about the angioplasty procedure includes at least one of inflation pressure and inflation volume of an associated balloon used in the angioplasty procedure (Hunter, [0194], [0256]-[0259], and [0310]-[0311]); and the determined treatment information includes at least one tissue property of treatment site (Hunter, [0257], [0273]: “Many of these parameters are important in the monitoring the need, effectiveness, timing and frequency of dialysis treatments and would be a great assistance to the clinician managing a renal patient; similarly comparing values in the arterial arm of the catheter, the venous arm of the catheter and the systemic circulation would also provide useful clinical data”, and [0374]).
Regarding claim 7 Hunter further teaches the obtained data comprises inflation volume of an associated balloon used in the angioplasty procedure, and the at least one electronic processor is programmed to (Hunter, [0093] and [0122]: “remote data-receiving device 82 may be, or include, a smart phone or tablet computer having circuitry sufficient to receive, demodulate, and recover sensor data from the wireless signal that the sensor module 10 transmits via the antenna 22. And the device 82 may also be configured to analyze, or otherwise process, the recovered sensor data”): input inflation volume to the digital twin; analyze the digital twin; and output the treatment information comprising a blockage stiffness of the stenosis (S) (Hunter, [0301] and [0514]).
Regarding claim 8 Hunter further teaches the at least one electronic processor is programmed to: output the treatment information on a display device of the electronic processing device (Hunter, [0133], [0248] and [0606]: “procedural and post-operative "real time" imaging of the medical device and the surrounding anatomy, the early identification of the development of medical device complications (often prior to becoming evident by other medical diagnostic procedures), and the patient's overall health status and response to treatment”).
Regarding claim 9 Hunter further teaches a catheter having a balloon disposed at a distal end thereof, the catheter being used to perform the angioplasty procedure (Hunter, [0160]-[0163], [0175], and [0272]).
Regarding claim 10 Hunter further teaches a sensor disposed inside of the balloon, the sensor configured to measure the data about the angioplasty procedure that is obtained by the electronic processor (Hunter, [0256]: “Figure 18 illustrates a balloon catheter having one or more ISMs containing a variety of sensors positioned in or on the balloon catheter (and/or potentially the guidewire) in order to monitor, in situ, the real-time operation of the catheter, the inflation and deflation of the balloon, the forces exerted by the balloon against adjacent tissues or devices {e.g. stents), flow levels through and around the balloon, and the catheter performance acutely and over time… While in certain embodiments, ISMs containing contact sensors, pressure sensors, and positions sensors can be utilized as shown in Figure 18, a wide variety of other sensors can also be used within the ISM that is placed in, on, or within the balloon catheter, including for example, fluid pressure sensors, accelerometers, vibration sensors, pulse sensors, liquid {e.g. , blood) volume sensors, liquid {e.g. , blood) flow sensors, liquid {e.g. , blood) chemistry sensors, liquid {e.g. , blood) metabolic sensors, mechanical stress sensors, and temperature sensors”).
Regarding claim 11 Hunter further teaches the sensor comprises one of a pressure sensor, an ultrasound sensor, a capacitive sensor, or an optical sensor (Hunter, [0256]: “Figure 18 illustrates a balloon catheter having one or more ISMs containing a variety of sensors positioned in or on the balloon catheter (and/or potentially the guidewire) in order to monitor, in situ, the real-time operation of the catheter, the inflation and deflation of the balloon, the forces exerted by the balloon against adjacent tissues or devices {e.g. stents), flow levels through and around the balloon, and the catheter performance acutely and over time… While in certain embodiments, ISMs containing contact sensors, pressure sensors, and positions sensors can be utilized as shown in Figure 18, a wide variety of other sensors can also be used within the ISM that is placed in, on, or within the balloon catheter, including for example, fluid pressure sensors, accelerometers, vibration sensors, pulse sensors, liquid {e.g. , blood) volume sensors, liquid {e.g. , blood) flow sensors, liquid {e.g. , blood) chemistry sensors, liquid {e.g. , blood) metabolic sensors, mechanical stress sensors, and temperature sensors” and [0269]-[0270]).
Regarding claim 12 Hunter further teaches the vascular therapy device used to perform the subsequent vascular therapy treatment, comprises a self-expanding vascular therapy device being deployed using the treatment information (Hunter, FIG. 11, [0041], [0154], and [0188]).
Regarding claim 13 Hunter further teaches an imaging device configured to acquire the data of the treatment site that is obtained by the electronic processor (Hunter, [0232], [0274], and [0555]).
Regarding claim 14 Hunter further teaches the imaging device comprises one of a computed tomography (CT) imaging device or an ultrasound (US) imaging device or an X-ray imaging device (Hunter, [0232], [0274], and [0555]).
Regarding claim 15 Hunter teaches a vascular therapy method (Hunter, Abstract) comprising: performing an angioplasty procedure by expanding a balloon at a treatment site in a vessel (V) of a patient (Hunter, [0253]: “the implementation of a medical or surgical procedure or device [e.g. , coronary angioplasty, peripheral angioplasty, angiography, dilation of an artery and/or placement of a stent, balloon septostomy, balloon sinuplasty, catheter-based ablation, balloon dilation catheters (esophageal, biliary, tracheal, bronchial, urethral, etc.)]”); while performing the angioplasty procedure (Hunter, [0253]: “the implementation of a medical or surgical procedure or device [e.g. , coronary angioplasty, peripheral angioplasty, angiography, dilation of an artery and/or placement of a stent, balloon septostomy, balloon sinuplasty, catheter-based ablation, balloon dilation catheters (esophageal, biliary, tracheal, bronchial, urethral, etc.)]”), obtaining data about the angioplasty procedure (Hunter, [0256]: “Figure 18 illustrates a balloon catheter having one or more ISMs containing a variety of sensors positioned in or on the balloon catheter (and/or potentially the guidewire) in order to monitor, in situ, the real-time operation of the catheter, the inflation and deflation of the balloon, the forces exerted by the balloon against adjacent tissues or devices {e.g. stents), flow levels through and around the balloon, and the catheter performance acutely and over time… While in certain embodiments, ISMs containing contact sensors, pressure sensors, and positions sensors can be utilized as shown in Figure 18, a wide variety of other sensors can also be used within the ISM that is placed in, on, or within the balloon catheter, including for example, fluid pressure sensors, accelerometers, vibration sensors, pulse sensors, liquid {e.g. , blood) volume sensors, liquid {e.g. , blood) flow sensors, liquid {e.g. , blood) chemistry sensors, liquid {e.g. , blood) metabolic sensors, mechanical stress sensors, and temperature sensors”); analyzing the data about the angioplasty procedure using an electronic processor to determine treatment information for a subsequent vascular therapy treatment of the treatment site (Hunter, [0257], [0273]: “Many of these parameters are important in the monitoring the need, effectiveness, timing and frequency of dialysis treatments and would be a great assistance to the clinician managing a renal patient; similarly comparing values in the arterial arm of the catheter, the venous arm of the catheter and the systemic circulation would also provide useful clinical data”, and [0374]).
Hunter does not teach the treatment information comprising selection of a vascular therapy device for use in the subsequent vascular therapy and performing the subsequent vascular therapy treatment of the treatment site using the vascular therapy device.
However, Grace teaches the treatment information comprising selection of a vascular therapy device for use in the subsequent vascular therapy (Grace, [0005], [0122]-[0123]: “The present disclosure relates generally to the use of medical devices for the treatment of vascular conditions. In particular, the present disclosure provides materials and methods for using electrode-induced pressure waves to disrupt vascular blockages and to deliver therapeutic agents to the blockage area”, [0155], and [0129-0140]: “There may be any number of electrode assemblies located at the distal end of the catheter and enclosed by the balloon” with alternate versions of the balloon-catheter system and different polymers for use therein and [0155] {the examiner asserts that each version of the balloon-catheter system being its own therapy device})); and performing the subsequent vascular therapy treatment of the treatment site using the vascular therapy device (Grace, FIG. 9, [0005], [0066], [0122]-[0123]: “The present disclosure relates generally to the use of medical devices for the treatment of vascular conditions. In particular, the present disclosure provides materials and methods for using electrode-induced pressure waves to disrupt vascular blockages and to deliver therapeutic agents to the blockage area”, [0150]-[0151], and [0161]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify Hunter to incorporate the teachings of Grace and account for improving therapeutic outcomes for people suffering from coronary artery disease and peripheral artery disease improve therapeutic outcomes for people suffering from CAD and PAD (Grace, Abstract and [0003]-[0006]).
Regarding claim 16 Hunter further teaches the obtaining of data includes measuring a maximum pressure and/or maximum expanded volume of the balloon during the angioplasty procedure (Hunter, [0180], [0194], [0257], and [0341]).
Regarding claim 17 Hunter further teaches the obtaining of data includes measuring an expanded volume of the balloon using imaging of the balloon during the balloon angioplasty procedure or measuring a volume of fluid flowed into the balloon during the angioplasty procedure (Hunter, [0180], [0194], [0257], [0341]-[0342], and [0487]).
Regarding claim 18 Hunter further teaches the analyzing of the data about the angioplasty procedure to determine the treatment information includes analyzing the pressure and/or expanded volume of the balloon during the angioplasty procedure to determine the treatment information comprising a tissue stiffness at the treatment site (Hunter, [0248], [0257], [0341], and [0606]: “procedural and post-operative "real time" imaging of the medical device and the surrounding anatomy, the early identification of the development of medical device complications (often prior to becoming evident by other medical diagnostic procedures), and the patient's overall health status and response to treatment”).
Regarding claim 19 Hunter further teaches the analyzing of the data about the angioplasty procedure to determine the treatment information includes analyzing the pressure and/or expanded volume of the balloon during the angioplasty procedure to determine the treatment information including a diameter and/or stiffness the vascular therapy device for use in the subsequent vascular therapy treatment (Hunter, [0248], [0253]: “the implementation of a medical or surgical procedure or device [e.g., coronary angioplasty, peripheral angioplasty, angiography, dilation of an artery and/or placement of a stent, balloon septostomy, balloon sinuplasty, catheter-based ablation, balloon dilation catheters (esophageal, biliary, tracheal, bronchial, urethral, etc.)]”, [0256]- [0257], [0341], and [0606]: “procedural and post-operative "real time" imaging of the medical device and the surrounding anatomy, the early identification of the development of medical device complications (often prior to becoming evident by other medical diagnostic procedures), and the patient's overall health status and response to treatment”).
Claim Rejections - 35 USC § 102
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 20 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hunter et al. (WO 2016044651 A1), hereinafter Hunter.
Regarding claim 20, Hunter teaches a balloon angioplasty system (Hunter, Abstract), comprising: a catheter (Hunter, [0012]: “Representative examples include drills, drill guides, mallets, guidewires, catheters, balloons, trocars, endoscopes, bone tunneling catheters, microsurgical tools and general surgical tools”, [0048], [0248], and [0250]); an expandible balloon disposed at a distal end of the catheter (Hunter, FIG. 34A, [0048], [0051], and [0064]); and a sensor disposed inside the balloon and configured to measure data about an angioplasty procedure performed at a treatment site using the catheter (Hunter, [0256]: “Figure 18 illustrates a balloon catheter having one or more ISMs containing a variety of sensors positioned in or on the balloon catheter (and/or potentially the guidewire) in order to monitor, in situ, the real-time operation of the catheter, the inflation and deflation of the balloon, the forces exerted by the balloon against adjacent tissues or devices {e.g. stents), flow levels through and around the balloon, and the catheter performance acutely and over time… While in certain embodiments, ISMs containing contact sensors, pressure sensors, and positions sensors can be utilized as shown in Figure 18, a wide variety of other sensors can also be used within the ISM that is placed in, on, or within the balloon catheter, including for example, fluid pressure sensors, accelerometers, vibration sensors, pulse sensors, liquid {e.g. , blood) volume sensors, liquid {e.g. , blood) flow sensors, liquid {e.g. , blood) chemistry sensors, liquid {e.g. , blood) metabolic sensors, mechanical stress sensors, and temperature sensors”); and at least one electronic processor programmed to (Hunter, [0093]: “Still referring to FIG. 1, the sensor-module controller 18 is configured to control the operations of the power supply 12, the sensor channel 36, the wireless interface 20, and other components of the sensor module 10, according to an embodiment, and includes a microcontroller or microprocessor 52, a memory 54, and a co-controller or co-processor, such as a digital- signal processor (DSP) 56, according to an embodiment. For clarity, hereinafter the microcontroller/microprocessor 52 is referred to as a microcontroller, it being understood that the microcontroller may instead be a microprocessor” and [0591]: “ the illustrated modules and/or systems are software modules/systems that include software instructions which, when executed by the CPU/DSP 808 or other processor, will program the processor to automatically perform the described operations for a module/system”): obtain the measured data during the angioplasty procedure (Hunter, [0180], [0194], [0257], and [0341]); retrieve a digital twin of the treatment site from a database (Hunter, [0588] and [0590]); and determine treatment information applied to a subsequent vascular therapy treatment of the treatment site using the retrieved digital twin (Hunter, [0256]-[0257], [0273]: “Many of these parameters are important in the monitoring the need, effectiveness, timing and frequency of dialysis treatments and would be a great assistance to the clinician managing a renal patient; similarly comparing values in the arterial arm of the catheter, the venous arm of the catheter and the systemic circulation would also provide useful clinical data”, and [0374]).
Response to Arguments
Applicant's arguments filed 03/17/2026 have been fully considered. Regarding the previous Claim Objections, the amendments to the claims have corrected the informalities.
Regarding the 35 U.S.C. 101 Rejection, Applicant argues the claims do not recite an abstract idea of certain method of organizing human activity. Applicant argues the Examiner did not identify whether claims recite the subgrouping of “social activities, teaching, or following rules or instructions”. Examiner respectfully disagrees. The Office Action clearly states the certain methods of organizing human activity subgrouping (see above “cover the abstract idea of a certain method of organizing human activity because they recite managing personal behavior or relationships or interactions between people (i.e. social activities, teaching, and following rules or instructions”). A person is a capable of performing the limitations of performing, obtaining, retrieving, determining, selecting, and performing. MPEP 2106.04(a)(2) states “the sub-groupings encompass both activity of a single person (for example, a person following a set of instructions or a person signing a contract online) and activity that involves multiple people (such as a commercial interaction), and thus, certain activity between a person and a computer (for example a method of anonymous loan shopping that a person conducts using a mobile phone) may fall within the “certain methods of organizing human activity” grouping”.
Applicant argues any alleged abstract idea is integrated into a practical application because of the vascular therapy device. Examiner respectfully disagrees. The vascular therapy device is recited at a high level and merely is being applied to the abstract idea. MPEP 2106.05(f) states “Use of a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not integrate a judicial exception into a practical application or provide significantly more. See Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). Similarly, “claiming the improved speed or efficiency inherent with applying the abstract idea on a computer” does not integrate a judicial exception into a practical application or provide an inventive concept. Intellectual Ventures I LLC v. Capital One Bank (USA), 792 F.3d 1363, 1367, 115 USPQ2d 1636, 1639 (Fed. Cir. 2015)”. Furthermore, the limitation of “performing the subsequent vascular therapy using the vascular therapy device” in claim 15 and “determine treatment information applied to a subsequent vascular therapy treatment of the treatment site using the retrieved digital twin” in claim 20 do not integrate the identified abstract idea into a practical application as there is no improvement to the selected vascular therapy device or retrieved digital twin (e.g., no improvement to technology, technical field, underlying computer or devices), the basis of vascular device selection or digital twin retrieval is not specific or particular or addresses any technical problem, and thus, “using” the vascular therapy device or retrieved digital twin amounts to generally linking the additional elements to the abstract idea in an “apply it” manner.
Applicant argues the claims recite a technical improvement of improving vascular therapy based on data from a preceding angioplasty procedure by enabling selection of an appropriate vascular therapy device to use in the vascular therapy. Examiner respectfully disagrees. The improvement is a not a technological improvement to the device or other additional elements, but rather a business practice improvement. There is no basis in the claims in which the vascular therapy device is selected; selection of a vascular therapy device for use in subsequent vascular therapy is encompassed within the step of determin[ing] treatment information for a subsequent therapy treatment in claim 1. In claim 15, the determined treatment information again comprises selection of a vascular therapy device for use, but is based on analyzing data about the angioplasty procedure; however, there is still no basis in which the vascular therapy device is selected, even based on the analysis of angioplasty procedure data. There is no tie between the angioplasty procedure and subsequent vascular therapy treatment. Instead, the selected vascular therapy device may be based on other factors, such as availability, or preference. Thus, there is nothing recited in the claim that clearly shows or demonstrates how the selected vascular therapy device improves vascular therapy. Furthermore, the selection of a vascular therapy device for use in subsequent vascular therapy is considered to be part of the abstract idea, and not an additional element.
See MPEP 2106.05(a) states “It is important to note, the judicial exception alone cannot provide the improvement. The improvement can be provided by one or more additional elements. See the discussion of Diamond v. Diehr, 450 U.S. 175, 187 and 191-92, 209 USPQ 1, 10 (1981)) in subsection II, below. in addition, the improvement can be provided by the additional element(s) in combination with the recited judicial exception. See MPEP § 2106.04(d) (discussing Finjan, Inc. v. Blue Coat Sys., Inc., 879 F.3d 1299, 1303-04, 125 USPQ2d 1282, 1285-87 (Fed. Cir. 2018))” and “An important consideration in determining whether a claim improves technology is the extent to which the claim covers a particular solution to a problem or a particular way to achieve a desired outcome, as opposed to merely claiming the idea of a solution or outcome. McRO, 837 F.3d at 1314-15, 120 USPQ2d at 1102-03; DDR Holdings, 773 F.3d at 1259, 113 USPQ2d at 1107. In this respect, the improvement consideration overlaps with other considerations, specifically the particular machine consideration (see MPEP § 2106.05(b)), and the mere instructions to apply an exception consideration (see MPEP § 2106.05(f))”.
Applicant argues the claims amount to significantly more than the abstract idea. Examiner respectfully disagrees. As stated above the additional elements are recited at a high level such that they amount to merely apply it to the abstract idea (see MPEP 2106.05(f) and MPEP 2106.05: “Based on this analysis, the Court concluded that the claims amounted to “‘nothing significantly more’ than an instruction to apply the abstract idea of intermediated settlement using some unspecified, generic computer”, and therefore held the claims ineligible because they were directed to a judicial exception and failed the second part of the Alice/Mayo test. Alice Corp., 573 U.S. at 225-27, 110 USPQ2d at 1984”). Therefore, the 35 U.S.C. 101 Rejection is maintained.
Applicant’s arguments with respect to claims 1 and 15 with the amendments of “the treatment information comprising selection of a vascular therapy device for use in the subsequent vascular therapy” and “performing the subsequent vascular therapy treatment of the treatment site using the vascular therapy device” have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/R.S.S./Examiner, Art Unit 3681
/PETER H CHOI/Supervisory Patent Examiner, Art Unit 3681
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