DETAILED ACTION
Status
This Final Office Action is in response to the communication filed on 23 September 2025. Claims 1-67 and 69-170 have been canceled, claim 68 has been amended and claims 171-189 have been added; therefore, claims 68 and 171-189 are pending and presented for examination.
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 .
Response to Amendment
A summary of the Examiner’s Response to Applicant’s amendment:
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 23 September 2025 was filed after the mailing date of the application on 18 May 2023. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Examiner’s Note
The Examiner notes that “luminal tissue” does not appear to actually defined by Applicant’s specification; however, the background information (at Applicant p. 1, line 13 as submitted, ¶ 0002 as published) and description (at least at p. 14, lines 23-27 and p. 14, line 31 – p. 15, line 3), in addition to the Applicant’s and Inventor’s other patent applications (e.g., U.S. Patent Application Publication No. 2022/0287730 at ¶ 0047) indicates that “luminal tissue” is, or encompasses, vessels and/or arteries of the vascular system.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 187-189 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 187-188 are indicated as method claims that purport to depend from system claim 68 (since they recite an earlier claim and apparently attempt to limit that earlier parent claim – see MPEP § 608.01(n)(III)). MPEP § 2173.05(p)(II) says that “A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.” Claims 187-189 only recite limitations regarding the use of the system of claim 68; therefore, it is indefinite when infringement may or would occur.
Claim 189 depends from claim 188, but does not resolve the above issues and inherit the deficiencies of the parent claim(s); therefore claim 189 is also indefinite.
Claims 175 and 189 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claims 175 and 189 recite “wherein the catheter-based intravascular lithotripsy procedure comprises a method of imparting pulsatile energy to an internal luminal tissue location”.
However, the plain and ordinary meaning of the term “intravenous lithotripsy”, as required at parent claims 68 and 188 (depending from, and requiring the system of claim 68), is that the required intravascular lithotripsy procedure of the parent claims necessarily comprises imparting pulsatile energy to an internal luminal tissue location.
As such, both claims 175 and 189 only recite a limitation that is already required at the parent claim(s). Therefore, claims 175 and 189 fail to further limit the subject matter of the claim upon which they depend.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 68 and 171-189 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Please see the following Subject Matter Eligibility (“SME”) analysis:
For analysis under SME Step 1, the claims herein are directed to a method (claims) and system (claim 68 and 171-189), which would be classified under one of the listed statutory classifications (SME Step 1=Yes).
For analysis under revised SME Step 2A, Prong 1, independent claim 68 is directed to a system comprising: a catheter-based procedure information module, comprising: a first processor comprising memory operably coupled to the first processor, wherein the memory comprises instructions stored thereon, which, when executed by the first processor, cause the first processor to: receive data regarding a catheter-based intravascular lithotripsy procedure from a catheter-based system; employ an algorithm to generate configuration settings for a catheter-based intravascular lithotripsy procedure based at least in part on accessing a repository of data comprising data from different locations and different subjects; and transmit the configuration settings to the catheter-based system; the catheter-based system, comprising: a catheter-based device; a second processor comprising memory operably coupled to the second processor, wherein the memory comprises instructions stored thereon, which, when executed by the second processor, cause the second processor to: transmit data regarding the catheter-based intravascular lithotripsy procedure to the catheter-based procedure information module; receive the configuration settings from the catheter-based procedure information module; and configure the catheter-based device based at least in part on the configuration settings received from the catheter-based procedure information module; and an operable connection between the catheter-based procedure information module and the catheter-based system.
The dependent claims (claims 171-189) appear to be encompassed by the abstract idea of the independent claims since they merely indicate the algorithm further using data from the intravascular lithotripsy procedure (claim 171), the algorithm comparing data from the intravascular lithotripsy procedure against previous procedure stored data (claim 172), accessing stored data (claim 173), the algorithm comprising a machine learning algorithm component (claim 174), the intravascular lithotripsy procedure imparting pulsate energy to an internal luminal tissue location (claims 175 and 189), the catheter-based procedure module being remote from the catheter-based system (claim 176), using distributed storage and/or cloud-based storage (claims 177-178), the catheter-based procedure module being configured to receive and transmit data regarding a plurality of catheter-based procedures (claim 179) at least two of which are performed at different locations such as treatment locations (claims 180-181), the received intravascular lithotripsy procedure data is pre-treatment or peri-treatment data (claims 182-183), the module being configured to receive from, and transmit to, a plurality of systems, including at different locations (claims 184-185), displaying the received settings for operator approval (claim 186), performing a intravascular lithotripsy procedure using the system of claim 68 (claim 187), and/or deploying the system settings and engaging the system as at claim 68 (claim 188).
The underlined portions of the claims are an indication of elements additional to the abstract idea (to be considered below).
The claim elements may be summarized as the idea of communicating data to receive procedure device settings; however, the Examiner notes that although this summary of the claims is provided, the analysis regarding subject matter eligibility considers the entirety of the claim elements, both individually and as a whole (or ordered combination). This idea is primarily within the Certain methods of organizing human activity (e.g. … commercial or legal interactions such as … legal obligations, … or business relations; and/or managing personal behavior or relationships between people such as social activities, teaching, and following rules or instructions) grouping(s) of subject matter. However, aside from the use of the processor(s) and computer-based communication, a human can or could collect or retrieve the data required at the claims and generate configuration settings for the intravascular lithotripsy procedure. As such, the instant claims can also be grouped in the mental process grouping of abstract ideas. Further, the Examiner notes that the only apparent argument presented regarding the amendment overcoming the earlier eligibility rejection(s) is that the algorithm generating configuration settings is alleged to prevent the abstract idea from being one of certain methods of organizing human activity (23 September 2025 Remarks at 8-9); however, the use of the algorithm is, at best, merely the use of the mathematical concepts grouping. The Examiner notes in relation to secondary or additional groupings that MPEP § 2106.04(II)(A)(2) indicates that
Because a judicial exception is not eligible subject matter, Bilski, 561 U.S. at 601, 95 USPQ2d at 1005-06 (quoting Chakrabarty, 447 U.S. at 309, 206 USPQ at 197 (1980)), if there are no additional claim elements besides the judicial exception, or if the additional claim elements merely recite another judicial exception, that is insufficient to integrate the judicial exception into a practical application. See, e.g., RecogniCorp, LLC v. Nintendo Co., 855 F.3d 1322, 1327, 122 USPQ2d 1377 (Fed. Cir. 2017) ("Adding one abstract idea (math) to another abstract idea (encoding and decoding) does not render the claim non-abstract"); Genetic Techs. Ltd. v. Merial LLC, 818 F.3d 1369, 1376, 118 USPQ2d 1541, 1546 (Fed. Cir. 2016) (eligibility "cannot be furnished by the unpatentable law of nature (or natural phenomenon or abstract idea) itself.").
Therefore, the claims are found to be directed to an abstract idea.
For analysis under revised SME Step 2A, Prong 2, the above judicial exception is not integrated into a practical application because the additional elements do not impose a meaningful limit on the judicial exception when evaluated individually and as a combination. The additional elements are using a system comprising: a catheter-based procedure information module, comprising: a first processor comprising memory operably coupled to the first processor, wherein the memory comprises instructions stored thereon, which, when executed by the first processor, cause the first processor to perform some activities, and a catheter-based system comprising: a catheter-based device; a second processor comprising memory operably coupled to the second processor, wherein the memory comprises instructions stored thereon, which, when executed by the second processor, cause the second processor to perform other of the indicated activities via the system, device(s); processor(s), memory(ies), and module(s). These additional elements do not reflect an improvement in the functioning of a computer or an improvement to other technology or technical field, implement the judicial exception with, or by using in conjunction with, a particular machine or manufacture that is integral to the claim, effect a transformation or reduction of a particular article to a different state or thing (there is no transformation/reduction of a physical article), and/or apply or use the judicial exception in some other meaningful way beyond generically linking use of the judicial exception to a particular technological environment.
The Examiner notes that the claims indicate an intravascular lithotripsy procedure; however, the claims merely recite configuration settings for the system, and do not recite performance of this procedure – except at dependent claims 187-189, which merely indicate performing the procedure. Applicant claim 186 indicates the display of the received configuration settings “for operator approval”; therefore, the received settings are not necessarily used for the procedure at parent claim 68, and thus also not necessarily used at dependent claims 187-189. MPEP § 2106.04(d)(2) discusses “Particular Treatment and Prophylaxis in Step 2A Prong Two”, where subsection “a. The Particularity Or Generality Of The Treatment Or Prophylaxis” recites, in part and as a continuation of an example, “consider a claim that recites the same abstract idea and ‘administering a suitable medication to a patient.’ This administration step is not particular, and is instead merely instructions to "apply" the exception in a generic way. Thus, the administration step does not integrate the mental analysis step into a practical application.” The current claims, even if considered as the procedure being performed, merely provides (and if the configuration settings were used, the use of) the configuration settings that are the same as or analogous to, “administering a suitable medication” – i.e., “administering the procedure with suitable device settings”.
Therefore, the claims appear to merely apply the judicial exception, include instructions to implement an abstract idea on a computer, or merely use a computer as a tool to perform the abstract idea. The additional elements appear to merely add insignificant extra-solution activity to the judicial exception and/or generally link the use of the judicial exception to a particular technological environment or field of use.
For analysis under SME Step 2B, the claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements, as indicated above, are merely “[a]dding the words ‘apply it’ (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, e.g., a limitation indicating that a particular function such as creating and maintaining electronic records is performed by a computer, as discussed in Alice Corp.” that MPEP § 2106.05(I)(A) indicates to be insignificant activity
There is no indication the Examiner can find in the record regarding any specialized computer hardware or other “inventive” components, but rather, the claims merely indicate computer components which appear to be generic components and therefore do not satisfy an inventive concept that would constitute “significantly more” with respect to eligibility. Applicant specification pg. 9, line 4 to pg. 10, line 6 (as submitted, ¶¶ 0030-0032 as published) indicates the use or envisioning of general purpose processors and/or equipment.
The individual elements therefore do not appear to offer any significance beyond the application of the abstract idea itself, and there does not appear to be any additional benefit or significance indicated by the ordered combination, i.e., there does not appear to be any synergy or special import to the claim as a whole other than the application of the idea itself.
The dependent claims, as indicated above, appear encompassed by the abstract idea since they merely limit the idea itself; therefore the dependent claims do not add significantly more than the idea.
Therefore, SME Step 2B=No, any additional elements, whether taken individually or as an ordered whole in combination, do not amount to significantly more than the abstract idea, including analysis of the dependent claims.
Please see the Subject Matter Eligibility (SME) guidance and instruction materials at https://www.uspto.gov/patent/laws-and-regulations/examination-policy/subject-matter-eligibility, which includes the latest guidance, memoranda, and update(s) for further information.
NOTICE
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 of this title, 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.
Claims 68 and 171-189 are rejected under 35 U.S.C. 103 as being unpatentable over Adams et al. (U.S. Patent No. 5,318,533, hereinafter Adams) in view of Roman et al. (U.S. Patent Application Publication No. 2007/0223574, hereinafter Roman) in further view of Nguyen et al. (U.S. Patent Application Publication No. 2019/0388110, hereinafter Nguyen) and in still further view of Ughi et al. (U.S. Patent Application Publication No. 2025/0339034, hereinafter Ughi).
Claim 68. (Currently Amended) A system comprising:
a catheter-based procedure information module (see Adams at least at, e.g., column:lines 7:1-33, “Microprocessor 110 includes an EPROM program memory 112 and a RAM data memory 114. Memory 112 contains the software program for operating processor 110, whereas memory 114 stores data processed by the processor for display and/or later recording. Real time clock 116 generates time information, and battery backup 118 maintains the operation of clock 116 and the contents of memory 114 in the event of a power failure. Data is processed by microprocessor 110 for storage in memory 114 as well as for display on display device 120. Thus, RAM memory 114 contains data regarding the history of the procedure, including pressures and times of inflation. Data may be printed to a permanent record by printer 122. Keyboard 124 provides input to the microprocessor for inputting other data, such as patient information and preestablished limits to pressure and duration. Alarm 126 is responsive to microprocessor 110 to provide an audible and/or visual alarm in the event a limit is exceeded. Data memory card 128 is optionally provided to permit patient data to be pre-recorded thereon and to permit data to be recorded concerning the history of the procedure, the memory card being a permanent part of the patient's record. Conveniently, at least display device 120, alarm 126 and light sensitive diode 102 are in the room where the angioplasty procedure is being performed. For example, these units may be enclosed in a housing mounted to the wall of the operating room or to an IV pole in the view of the cardiologist performing the procedure. It may be convenient to enclose the other components of FIG. 5 in the same housing, or they may be at a different location”; citation hereafter by number only), comprising:
a first processor comprising memory operably coupled to the first processor, wherein the memory comprises instructions stored thereon, which, when executed by the first processor, cause the first processor (7:1-33 as above) to:
receive data regarding a catheter-based procedure from a catheter-based system (7:1-33 as above); and
the catheter-based system , comprising:
a catheter-based device 7:1-33, angioplasty being performed requires the device, 7:34-35 balloon catheter);
transmit data regarding the catheter-based … procedure to the catheter-based procedure information module (7:1-33 as above);
receive the configuration settings (8:9-10, “limits of duration, pressure and number of inflations may be preset into microprocessor”, 8:20-26, “The program stored in EPROM program memory 112 controls microprocessor 110 to determine current pressure, maximum pressure, duration of inflation, number of inflations and other relevant information related to the time, pressure and duration of the procedure. Patient data, preestablished limits and other information may be inputted”) ; and
configure the catheter-based device based at least in part on the configuration settings received from the catheter-based procedure information module (8:9-10, “limits of duration, pressure and number of inflations may be preset into microprocessor”, 8:20-26, “The program stored in EPROM program memory 112 controls microprocessor 110 to determine current pressure, maximum pressure, duration of inflation, number of inflations and other relevant information related to the time, pressure and duration of the procedure. Patient data, preestablished limits and other information may be inputted”).
Adams, however, does not appear to explicitly disclose a second processor comprising memory operably coupled to the second processor, wherein the memory comprises instructions stored thereon, which, when executed by the second processor, cause the second processor to [perform the procedure], the settings being from the catheter-based procedure information module, transmit the configuration settings to the catheter-based system, that the procedure is an intravascular lithotripsy procedure, employ an algorithm to generate configuration settings for a catheter- based intravascular lithotripsy procedure based at least in part on accessing a repository of data comprising data from different locations and different subjects, and an operable connection between the catheter-based procedure information module and the catheter-based system. Where Adams indicates setting and controlling the procedure device, such as via keyboard or other instructions, and indicates that “Conveniently, at least display device 120, alarm 126 and light sensitive diode 102 are in the room where the angioplasty procedure is being performed…. It may be convenient to enclose the other components of FIG. 5 in the same housing, or they may be at a different location” (Adams at 7:25-33), it is does not appear explicit that a second processor is transmitting the configuration. Roman, though, teaches “A method of and apparatus for transmitting video images preferably allows a specially trained individual to remotely supervise, instruct, and observe administration of medical tests conducted at remote locations…. The transmitting device transmits the video images to the remote receiving device either for live display through the source device or for pre-recorded display through a video recorder device. The remote receiving device is also capable of communicating with the transmitting device while simultaneously receiving video images. The source device is preferably a medical test device such as an ultrasound, a sonogram, an echocardiogram, an angioplastigram, and the like. This medical test device preferably generates video images for the transmitting device. The transmitting device captures the video images in real-time from the source device and compresses these video images utilizing a compression method prior to transmitting data representing the video images to the remote receiving device. Remote users utilizing the remote receiving devices are capable of remotely controlling a number of parameters relating to the source device and the transmitting device. Such parameters include compression method, image quality, storage of the video images on the transmitting device, manipulating and controlling the source device, and the like” (Roman at 0009). Therefore, the Examiner understands and finds that to use a second processor operatively connecting the procedure information module and the catheter device so as to transmit the device configuration to the catheter system is applying a known technique to a known device, method, or product ready for improvement to yield predictable results so as to provide settings and remote control capabilities without requiring all the persons and controls be at the same location.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine or modify the procedures and devices of Adams with the remote controls of Roman in order to use a second processor operatively connecting the procedure information module and the catheter device so as to provide settings and remote control capabilities without requiring all the persons and controls be at the same location.
The rationale for combining in this manner is that to use a second processor operatively connecting the procedure information module and the catheter device is applying a known technique to a known device, method, or product ready for improvement to yield predictable results so as to provide settings and remote control capabilities without requiring all the persons and controls be at the same location as explained above.
Adams in view of Roman, however, does not appear to explicitly disclose that the procedure is an intravascular lithotripsy procedure, and employ an algorithm to generate configuration settings for a catheter- based intravascular lithotripsy procedure based at least in part on accessing a repository of data comprising data from different locations and different subjects. Nguyen, though, teaches that “More recently, a system has been developed wherein electrodes are disposed in the angioplasty balloon. Once the balloon is initially positioned adjacent a blockage, a series of high voltage pulses are applied to the electrodes in a manner to generate a series of shock waves. The shock waves act to crack calcified lesions. Once the lesions are cracked, the balloon can be inflated, in a more gentle fashion, to expand the vessel and improve circulation” (Nguyen at 0004), with configuration settings for procedures (see Nguyen at least at 0030, “one or more of the other factors that affect the efficiency of the operation, such as the flow rate of the conductive fluid, the applied voltage, the shape and composition of the occlusion, are taken into account when setting distance B to achieve an optimal configuration”, and 0039, “The system 500 further includes a control console 502 having an infusion pump 504 and a generator 506. The infusion pump provides the flow of conductive fluid (e.g., saline) toward the forward bubble generating tip via the irrigation lumen. In some examples, an auxiliary pump may be used for aspiration and removal of debris. The generator serves as a voltage supply for the electrodes at the forward bubble generating tip. The pulses have a voltage in the range of 500 to 3000 volts and more preferably 600 to 1000 volts. Ideal electrical energies applied for CTO crossing are very low (between 5 and 50 mJ per pulse) to avoid generating excess heat, and more preferably 30 mJ. Current ranges from 1-15 Amperes. The pulses are generated with a repetition rate in the range of 14 to 800 Hz”), where the where the indications are applicable to angioplasty or intravascular lithotripsy (Nguyen at 0040, “After the occlusion is crossed, the forward bubble generating tip can be withdrawn, while the guidewire can remain to allow the access of other tools such as angioplasty or Lithoplasty™ balloons using over the wire entry. Lithoplasty is the trademark of assignee directed to its intravascular lithotripsy (shock wave) catheters”). Therefore, the Examiner understands and finds that to perform an intravenous lithotripsy procedure is applying a known technique to a known device, method, or product ready for improvement to yield predictable results so as to enable applying shock waves to crack lesions.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine or modify the procedures and devices of Adams in view of Roman with the indication of intravenous lithotripsy of Nguyen in order to perform an intravenous lithotripsy procedure so as to enable applying shock waves to crack lesions.
The rationale for combining in this manner is that to perform an intravenous lithotripsy procedure is applying a known technique to a known device, method, or product ready for improvement to yield predictable results so as to enable applying shock waves to crack lesions as explained above.
Adams in view of Roman in further view of Nguyen, however, does not appear to explicitly disclose to employ an algorithm to generate configuration settings for a catheter-based intravascular lithotripsy procedure based at least in part on accessing a repository of data comprising data from different locations and different subjects. Ughi, though, teaches a “System 10 [that] can be configured to calculate various data metrics (e.g. via algorithms 315, 415, and/or 1015 described herein) which can be displayed to aid the operator. For example, prior to an interventional procedure (e.g. a stenting procedure)” such as “measuring the degree of tapering of identified side-branches (e.g. using a “branch law”, such as Murray's law)” …, an ‘ideal stent expansion’,” etc. as related to “e.g. angioplasty and/or stent implantation” (Ughi at 0183) and that “Diagnostic and/or therapeutic medical procedure data, including OCT image data and other clinical data collected by system 10 and other medical devices, is collected at one or more (e.g. many) clinical sites (CS). This collected medical procedure data, “MP data” herein, can be transferred to a centralized data storage and/or processing location, such as server 400 shown and described herein (e.g. a cloud-based server as shown in FIG. 29). MP Data can be transferred from server 400 to one or more clinical sites CS. MP Data (e.g. from multiple patients treated at multiple clinical sites CS) can be analyzed via one or more algorithms of system 10 (e.g. an AI algorithm, such as algorithm 1015 as described herein), such as to generate improved treatment plans for the diagnosis and/or therapeutic treatment of future patients” (Ughi at 0243). Therefore, the Examiner understands and finds that to analyze multiple patients from multiple locations for an algorithm related to intravenous procedures is applying a known technique to a known device, method, or product ready for improvement to yield predictable results so as to provide procedure insights.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine or modify the procedures and devices of Adams in view of Roman in further view of Nguyen with the algorithm of Ughi in order to analyze multiple patients from multiple locations for an algorithm related to intravenous procedures so as to provide procedure insights.
The rationale for combining in this manner is that to analyze multiple patients from multiple locations for an algorithm related to intravenous procedures is applying a known technique to a known device, method, or product ready for improvement to yield predictable results so as to provide procedure insights as explained above.
Claim 171: Adams in view of Roman in further view of Nguyen in still further view of Ughi discloses the system according to claim 68, wherein the algorithm is configured to generate configuration settings further based at least in part on data regarding the catheter-based intravascular lithotripsy procedure received by the catheter-based procedure information module from the catheter-based system (Roman at 0009, Nguyen at 0004, 0030, and 0039-0040 as above, Ughi at 0183 and 0243, as above, as combined above and using the rationale as at the combination above).
Claim 172: Adams in view of Roman in further view of Nguyen in still further view of Ughi discloses the system according to claim 68, wherein the algorithm is configured to compare at least a subset of data regarding the catheter-based intravascular lithotripsy procedure against data from a previous catheter-based procedure stored in the repository (Ughi at 0183 and 0243, as above, as combined above and using the rationale as at the combination above).
Claim 173: Adams in view of Roman in further view of Nguyen in still further view of Ughi discloses the system according to claim 68, wherein the algorithm is configured to access data regarding a plurality of previous catheter-based procedures stored in the repository (Ughi at 0183 and 0243, as above, as combined above and using the rationale as at the combination above).
Claim 174: Adams in view of Roman in further view of Nguyen in still further view of Ughi discloses the system according to claim 68, wherein the algorithm comprises a machine learning algorithm component (Ughi at 0040, 0172, 0193, as above, as combined above and using the rationale as at the combination above).
Claim 175: Adams in view of Roman in further view of Nguyen in still further view of Ughi discloses the system according to claim 68, wherein the catheter-based intravascular lithotripsy procedure comprises a method of imparting pulsatile energy to an internal luminal tissue location (Nguyen at 0004 and 0040 as above, and using the rationale as at the combination above).
Claim 176: Adams in view of Roman in further view of Nguyen in still further view of Ughi discloses the system according to claim 68, wherein the catheter-based procedure information module is remote from the catheter-based system (Adams at 7:25-33, Roman at 0009 as above, as combined above and using the rationale as at the combination above).
Claim 177: Adams in view of Roman in further view of Nguyen in still further view of Ughi discloses the system according to claim 68, wherein the repository of data is stored in distributed data storage (Ughi at 0243, “cloud-based server”, as combined above and using the rationale as at the combination above).
Claim 178: Adams in view of Roman in further view of Nguyen in still further view of Ughi discloses the system according to claim 68, wherein the repository of data is stored in cloud-based data storage (Ughi at 0243, “cloud-based server”, as combined above and using the rationale as at the combination above).
Claim 179: Adams in view of Roman in further view of Nguyen in still further view of Ughi discloses the system according to claim 68, wherein the catheter-based procedure information module is configured to receive and transmit data regarding a plurality of catheter-based procedures (Adams as above, Roman at 0009, Nguyen at 0004, 0030, and 0039-0040 as above, Ughi at 0183 and 0243, as above, as combined above and using the rationale as at the combination above)
Claim 180: Adams in view of Roman in further view of Nguyen in still further view of Ughi discloses the system according to claim 179, wherein at least two of the plurality of catheter-based procedures are performed at different locations (Ughi at 0183 and 0243, as above, as combined above and using the rationale as at the combination above)
Claim 181: Adams in view of Roman in further view of Nguyen in still further view of Ughi discloses the system according to claim 180, wherein the different locations comprise different catheter-based procedure treatment locations (Roman at 0009, Nguyen at 0004, 0030, and 0039-0040 as above, Ughi at 0183 and 0243, as above, as combined above and using the rationale as at the combination above).
Claim 182: Adams in view of Roman in further view of Nguyen in still further view of Ughi discloses the system according to claim 68, wherein data regarding the catheter-based intravascular lithotripsy procedure communicated to the catheter-based procedure information module comprises pre-treatment data (Adams at 7:1-33, 87:67-8:32).
Claim 183: Adams in view of Roman in further view of Nguyen in still further view of Ughi discloses the system according to claim 68, wherein data regarding the catheter-based intravascular lithotripsy procedure communicated to the catheter-based procedure information module comprises peri-treatment data (Adams at 7:1-33, 87:67-8:32).
Claim 184: Adams in view of Roman in further view of Nguyen in still further view of Ughi discloses the system according to claim 68, wherein the catheter-based procedure information module is configured to receive data from, and transmit data to, a plurality of catheter-based systems (Roman at 0009, Nguyen at 0004, 0030, and 0039-0040 as above, Ughi at 0183 and 0243, as above, as combined above and using the rationale as at the combination above).
Claim 185: Adams in view of Roman in further view of Nguyen in still further view of Ughi discloses the system according to claim 184, wherein at least two of the plurality of catheter-based systems are located at different locations (Ughi at 0183 and 0243, as above, as combined above and using the rationale as at the combination above).
Claim 186: Adams in view of Roman in further view of Nguyen in still further view of Ughi discloses the system according to claim 68, wherein the catheter-based system is configured to cause the configuration settings received from the catheter-based procedure information module to be displayed for operator approval (Adams at 7:1-33, Roman at 0009, Nguyen at 0004, 0030, and 0039-0040 as above, Ughi at 0183 and 0243, as above, as combined above and using the rationale as at the combination above).
Claim 187: Adams in view of Roman in further view of Nguyen in still further view of Ughi discloses a method of administering treatment to a subject by performing a catheter-based intravascular lithotripsy procedure to impart pulsatile energy to an internal luminal tissue location using a system according to claim 68 (Adams at 7:1-33, Roman at 0009, Nguyen at 0004, 0030, and 0039-0040 as above, Ughi at 0183 and 0243, as above, as combined above and using the rationale as at the combination above).
Claim 188: Adams in view of Roman in further view of Nguyen in still further view of Ughi discloses a method comprising: deploying a system according to claim 68, wherein the catheter-based system is configured based on configuration settings for a catheter-based intravascular lithotripsy procedure generated by the catheter-based procedure information module; and engaging the catheter-based system to administer the catheter-based intravascular lithotripsy procedure to a subject (Adams at 7:1-33, Roman at 0009, Nguyen at 0004, 0030, and 0039-0040 as above, Ughi at 0183 and 0243, as above, as combined above and using the rationale as at the combination above).
Claim 189: Adams in view of Roman in further view of Nguyen in still further view of Ughi discloses the method according to claim 188, wherein the catheter-based intravascular lithotripsy procedure comprises a method of imparting pulsatile energy to an internal luminal tissue location (Adams at 7:1-33, Roman at 0009, Nguyen at 0004, 0030, and 0039-0040 as above, Ughi at 0183 and 0243, as above, as combined above and using the rationale as at the combination above).
Response to Arguments
Applicant's arguments filed 23 September 2025 have been fully considered but they are not persuasive.
Applicant first argues the 101 rejection (Remarks at 7-9), indicating that the amendment regarding employing an algorithm to generate configuration settings overcomes the previous rejection (Id. at 8). However, as noted above at the current rejection, merely adding elements from another or secondary grouping of abstract ideas does not indicate that the claims are not still directed to an abstract idea. The Examiner notes that it would appear analogous to employ an algorithm from a person’s memory or from consultation with others (the algorithm need not be complex or complicated – it just appears to require some form of rule(s) or general relation to a subject so as to provide relatively appropriate settings. As such, the “algorithm” appears to be analogous to an operator’s memory regarding settings to use based on performing the same procedure at various locations and times on multiple patients, and/or having been trained with respect to the appropriate settings based on the data.
Applicant further argues that “the claims integrate any alleged abstract idea … into a practical application that improves the functioning of catheter-based systems in performing catheter-based intravascular lithotripsy procedures…. That is, generating configuration settings with the benefit of historical procedure information constitutes an improvement to technology or a technical field, such that the instant claims, as amended, integrate any alleged abstract idea into a practical application. Similarly, such improvements to technology or a technical field also constitute an inventive concept such that the claims, as amended, amount to significantly more than any alleged abstract idea.” (Id. at 9). However, there is no improvement to any technology – any settings provided are apparently all available for use regardless of the algorithm use, so any technology is apparently exactly the same. The only apparent “improvement”, if there is one, is the data selection – i.e., the configuration settings, and not the technology used.
Applicant then argues the prior art rejections (Remarks at 9-18); however, the amending necessitates new grounds of rejection. Therefore, the arguments are considered moot and not persuasive. Please see the current rejections above.
Conclusion
THIS ACTION IS MADE FINAL. 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.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Mansker et al. (U.S. Patent Application Publication No. 2014/0188515, hereinafter Mansker) describes data communication and storage related to, among others, catheter devices or procedures, including distributed storage such as cloud-based storage (see Mansker at 0040, 0073)
Kreidieh et al., Utility of a cloud-based lesion data collection software to record, monitor, and analyze an ablation strategy. Heart Rhythm O2. 2022 Apr 6;3(3):319-322. doi: 10.1016/j.hroo.2022.03.006. PMID: 35734303; PMCID: PMC9207725. Downloaded from https://www.sciencedirect.com/science/article/pii/S2666501822000964?via%3Dihub on 17 Jun 2025. Describing cloud-based data collection and storage related to catheter procedures.
Galougahi et al., Intravascular Lithotripsy in Cardiovascular Interventions, American College of Cardiology, dated 17 July 2020, downloaded from https://www.acc.org/Latest-in-Cardiology/Articles/2020/07/17/08/00/Intravascular-Lithotripsy-in-Cardiovascular-Interventions on 6 November 2025, indicating that “intravascular lithotripsy (IVL) … [is where a] balloon-catheter system includes miniaturized and arrayed lithotripters that are integrated into a semi-compliant balloon filled with a mixture of contrast and saline (Figure 1). The lithotripters generate shock waves that are similar in their waveform to the shock waves generated by the lithotripters” (at p. 1).
Hall, Hurst (Lanny), Intravascular lithotripsy: Using sonic waves to break up plaque in heart arteries, dated 27 April 2022, downloaded 6 November 2025 from https://utswmed.org/medblog/intravascular-lithotripsy-unclog-arteries/, indicating that
Approved by the U.S. Food and Drug Administration (FDA) in February 2021, IVL is based on technology developed in the early 1980s that uses shock waves to break apart kidney stones.
Similarly, IVL employs sonic waves to create cracks in the calcium deposits in an artery, providing just enough wiggle room for the stent to properly expand. The process improves blood flow with no pain and less arterial wall damage.
(at p. 2)
Honton et al., Best Practice in Intravascular Lithotripsy. Interv Cardiol. 2022 Jan 28;17:e02. doi: 10.15420/icr.2021.14. PMID: 35154381; PMCID: PMC8826142. Downloaded from https://pmc.ncbi.nlm.nih.gov/articles/PMC8826142/ on 7 November 2025, discusses intravascular lithotripsy (IVL) (at pp. 1-2), and that “In our experience, optical coherence tomography (OCT) is the preferred imaging modality due to its high spatial resolution and ability to measure calcification thickness. Intravascular ultrasound imaging (IVUS) is a valid alternative” (at Pre-procedural Evaluation, p. 3), and Several studies have suggested a pre-defined algorithm for analysing plaque characteristics and guiding the selection of PCI strategies and plaque preparation using OCT or IVUS (Figure 2)” (Id.).
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/SCOTT D GARTLAND/
Primary Examiner, Art Unit 3685
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