DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 03/02/2026 has been entered.
Response to Amendment
The amendment of 02/03/2026 has been entered and fully considered by the examiner. Claims 1, 15, are amended. Claims 8-14, 16, and 21-26 are canceled. Claims 1-7, 15, and 17-20 are currently pending in the application with claims 1 and 15 being independent.
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 1-7, 15, and 17-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1 of the subject matter eligibility test (see MPEP 2106.03).
Claim 1 is directed to an a “method” which describes one of the four statutory categories of patentable subject matter, i.e., a process.
Claim 15 is directed towards an “apparatus” which describes one of the four statutory categories of patentable subject matter, i.e., a machine.
Claims 1 and 15 are directed to Step 2A of the subject matter eligibility test (see MPEP 2106.04).
Prong One:
Claims 1 and 15 recite (“sets forth” or “describes”) the abstract idea of a mental process, substantially as follows: monitoring one or more device attributes during a procedure, detecting device manipulations based on attributes including monitoring of relative distances between one or more sensors over time to detect mechanical manipulations and determining whether the deice may be reprocessed for subsequent use based at least in part on the detected device manipulations, updating a total usage capability of the medical device based on type and magnitude of mechanical manipulations and determined whether the device may be reprocessed for use in a subsequent procedure.
In claims 1 15, the above recited steps can be practically performed in the human mind, with the aid of a pen and paper or with a generic computer, in a computer environment, or merely using the generic computer as a tool to perform the steps. If a person were to visually examine, i.e., perform an observation, he/she would be able to identify the movements of the device or its erosion over time or the way the device moves or operates visually. He/she would further be able to determine whether the device is usable or suitable for further use or not based on the observations. There is nothing recited in the claim to suggest an undue level of complexity in how the attributes and manipulations are to be detected. Therefore, a person would be able to perform the monitoring, detection and determination steps mentally or with a generic computer.
Prong Two: Claims 1and 15 do not include additional elements that integrate the mental process into a practical application.
This judicial exception is not integrated into a practical application. In particular, claims 8 and 15 recite (1) additional steps of receiving location information from sensors, and (2) further an addition step of storing the detected device manipulations.
The steps in (1) represent merely data gathering or pre-solution activities that are necessary for use of the recited judicial exception and are recited at a high level of generality with conventionally used tools (see below Step IIB for further details).
The step in (2) represents merely notification outputting the data and a post-solution activity and is recited at a high level of generality.
As a whole, the additional elements merely serve to gather and feed information to the abstract idea and to output a notification based on the abstract idea, while generically implementing it on conventionally used tools. There is no practical application because the abstract idea is not applied, relied on, or used in a meaningful way. No improvement to the technology is evident, and the estimated bio-information is not outputted in any way such that a practical benefit is realized. Therefore, the additional elements, alone or in combination, do not integrate the abstract idea into a practical application.
Step 2B of the subject matter eligibility test (see MPEP 2106.05).
Claims 1, 15 do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above, the claims recite additional steps of receiving location data from sensors, and saving the output information. These steps represents mere data gathering, data outputting or pre/post/extra-solution activities that are necessary for use of the recited judicial exception and are recited at a high level of generality.
Accordingly, these additional steps and tools for measuring the movements and store the results amount to no more than insignificant conventional extra-solution activity. Mere insignificant conventional extra-solution activity cannot provide an inventive concept. The claims hence are not patent eligible.
Dependent Claims
The following dependent claims merely further define the abstract idea and are, therefore, directed to an abstract idea for similar reasons:
Defining the attributes determined (claim 2, 6, 10)
defining the bio-information (claim 13).
The following dependent claims merely further describe the extra-solution activities and therefore, do not amount to significantly more than the judicial exception or integrate the abstract idea into a practical application for similar reasons:
determining various information bout the device (claim 3-4, 7, 14, 16-20);
details about the device used in the method (claim 5, 12, 13);
details about the sensors used (claims 9, 11);
Taken alone and in combination, the additional elements do not integrate the judicial exception into a practical application at least because the abstract idea is not applied, relied on, or used in a meaningful way. They also do not add anything significantly more than the abstract idea. Their collective functions merely provide computer/electronic implementation and processing, and no additional elements beyond those of the abstract idea. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements individually. There is no indication that the combination of elements improves the functioning of a computer, output device, improves technology other than the technical field of the claimed invention, etc. Therefore, the claims are rejected 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 6-7, 15-17, 19, and 20 are rejected under 35 U.S.C. 102 as being unpatentable over Hunter et al. (U.S. Publication No. 2020/0281471) hereinafter “Hunter” in view of Ruffaldi et al. (U.S. Publication No. 2024/0227191) hereinafter “Ruffaldi”.
Regarding claim 1, Hunter discloses a method of monitoring total usage capability of an insertable medical device, [see [0009] and [0012] of Hunter; the medical devices and associated insertable implants such as catheters, medical tubes, balloons, guidewires, trocars, endoscopes, microsurgical tools, etc.] the method comprising:
monitoring one or more device attributes associated with the insertable medical device during a duration of a procedure; [see [0016] of Hunter disclosing: “sensors can be placed in various locations in order to monitor function, physical integrity, wear, performance, potential side effects, of the medical device and its interface with the issue.] in which the insertable medical device is inserted within a patient’s body, wherein the one or more device attributes include location data associate with each of a plurality of sensors located on the insertable medical device; [see [0073]-[0074] and [0096]; a plurality of sensors are used and they can determined the absolute position of the sensor modules that are located on the device can be known], and wherein the location data is monitored continuously over a duration of the procedure. [see [0026]-[0027] and [0192] and [637]; the position data is recorded over time]
detecting device manipulations during the procedure based on the one or more device attributes; and [see [0015], [0019], [0026] and [0212] of Hunter disclosing that there are pressure sensors, location sensors, etc. that can detect any shock, tilt and rotation of the device and contact pressure with surrounding tissue, etc.], wherein detecting device manipulations during the procedure includes analyzing the monitored location data associated with each of the plurality of sensors relative to one another during the duration of the procedure to detect mechanical device manipulations including flexing and/or bending of the medical device during the procedure. [see [0019] disclosing that different types of sensors can detect bending, cracking, breaking of the device]
Updating a total usage capability of the medical device base, at least in part, on the type and magnitude of mechanical device manipulations; and [see [0218]; the state of the degradation of the insertable medical device is detected from time to time based on changes in the sensor data (i.e. manipulations); see also [0637] disclosing that the sensor outputs are monitored and displayed over time]
determining whether the medical device may be reprocessed for use in a subsequent procedure based, on the updated total usage capability of the insertable medical device [see at least [0019], [0027] and [0218] of Hunter discloses determining whether the stent implanted has reached the end of its life or that a device is cracked, bent, and not capable of being used]
Hunter does not expressly disclose wherein analyzing the monitored location data associated with each of the plurality of sensors relative to one another during the duration of the procedure to detect mechanical device manipulations includes monitoring relative distances between one or more sensors over time to detect mechanical device manipulations, wherein the monitored relative distances between one or more sensors are compared to one or more threshold values to determine a type and magnitude of a mechanical device manipulation;
Ruffaldi, directed towards robotic surgical tool performance monitoring [see abstract of Ruffaldi] further discloses wherein analyzing the monitored location data associated with each of the plurality of sensors relative to one another during the duration of the procedure to detect mechanical device manipulations includes monitoring relative distances between one or more sensors over time to detect mechanical device manipulations [see [0122]-[0137]; the relative distance between two points are determined by the position sensor data], wherein the monitored relative distances between one or more sensors are compared to one or more threshold values [see [0132]-[0137] disclosing comparing the relative distances to a threshold] to determine a type and magnitude of a mechanical device manipulation; [see [0137]-[0139]; the type of anomaly can be determined for example distance above a max distance at rest can indicate structural damage., or twist (angles that are not within threshold); the magnitude of manipulation is the same as the relative distance between sensors which is determined (see [0122]-[0137]) of Ruffaldi)]
It would have been obvious to a person of ordinary skill level in the art at the time of the filing of the invention to modify the design of Hunter wherein analyzing the monitored location data associated with each of the plurality of sensors relative to one another during the duration of the procedure to detect mechanical device manipulations includes monitoring relative distances between one or more sensors over time to detect mechanical device manipulations, wherein the monitored relative distances between one or more sensors are compared to one or more threshold values to determine a type and magnitude of a mechanical device manipulation according to the teachings of Ruffaldi in order to provide efficient and reliable methods to determine functional integrity of surgical tools [see [0007] of Ruffaldi]
Regarding claim 6, Hunter further discloses that determining whether the medical device may be reprocessed for use in a subsequent procedure based, at least in part, on the detected device manipulations includes calculating a total usage capability of the insertable medical device [see [0028] of Hunter discloses that by getting information from various sensors of the device the integrity (i.e. usage capability) of the device can be determined]
Regarding claim 7, Hunter further discloses that detecting device manipulations during the procedure includes identifying the procedure, wherein identifying the procedure includes analyzing sensor the location data to determine: at least one overall geometry assumed by the insertable medical device during the procedure; or a path of the insertable medical device. [see [0644] disclosing that the plurality of sensors on the medical device can “provide information on the size, shape (i.e. geometry), (integrity, alignment and location of changes to the medical device, and/or medical device movement/migration. In particular, as noted above the image data can be collected over time, in order to visually show changes (e.g., a “movie” or ‘moving images”, which may be in 2D or 3D” (i.e. path) ]
Regarding claim 15, Hunter discloses a data process and analysis system [see [0008]; system of Hunter] configured to receive inputs measured by a plurality of sensors associated with an insertable medical device [see [0016] and [0020] of Hunter] during insertion of the insertable medical device within a patient’s body for a duration of a procedure. [see [0016] of Hunter disclosing: “sensors can be placed in various locations in order to monitor function, physical integrity, wear, performance, potential side effects, of the medical device and its interface with the issue.] the data process and analysis system including a processor [CPU/DSP 808] and memory for storing instructions executed by the processor [see [0658] of Hunter] to:
determine locations of the sensors based on inputs received from sensors during the duration of the procedure; [see [0096]; the absolute position of the sensor modules that are located on the device can be known],
detect device manipulations associated with the insertable medical device during the procedure based on the determined locations of the sensors; and [see [0016]-[0017] of Hunter and [0019] disclosing that different types of sensors can detect bending, cracking, breaking of the device]
update total usage capability of the insertable medical device base, at least in part, on the type and magnitude of mechanical device manipulations; and [see [0218]; the state of the degradation of the insertable medical device is detected from time to time based on changes in the sensor data (i.e. manipulations); see also [0637] disclosing that the sensor outputs are monitored and displayed over time]
determine whether the insertable medical device may be reprocessed for use in a subsequent medical procedure based, on the updated total usage capability of the insertable medical device. [see [0028] of Hunter discloses that by getting information from various sensors of the device the integrity (i.e. usage capability) of the device can be determined]
Hunter does not expressly disclose wherein analyzing the monitored location data associated with each of the plurality of sensors relative to one another during the duration of the procedure to detect mechanical device manipulations includes monitoring relative distances between one or more sensors over time to detect mechanical device manipulations, wherein the monitored relative distances between one or more sensors are compared to one or more threshold values to determine a type and magnitude of a mechanical device manipulation;
Ruffaldi, directed towards robotic surgical tool performance monitoring [see abstract of Ruffaldi] further discloses wherein analyzing the monitored location data associated with each of the plurality of sensors relative to one another during the duration of the procedure to detect mechanical device manipulations includes monitoring relative distances between one or more sensors over time to detect mechanical device manipulations [see [0122]-[0137]; the relative distance between two points are determined by the position sensor data], wherein the monitored relative distances between one or more sensors are compared to one or more threshold values [see [0132]-[0137] disclosing comparing the relative distances to a threshold] to determine a type and magnitude of a mechanical device manipulation; [see [0137]-[0139]; the type of anomaly can be determined for example distance above a max distance at rest can indicate structural damage., or twist (angles that are not within threshold); the magnitude of manipulation is the same as the relative distance between sensors which is determined (see [0122]-[0137]) of Ruffaldi)]
It would have been obvious to a person of ordinary skill level in the art at the time of the filing of the invention to modify the design of Hunter wherein analyzing the monitored location data associated with each of the plurality of sensors relative to one another during the duration of the procedure to detect mechanical device manipulations includes monitoring relative distances between one or more sensors over time to detect mechanical device manipulations, wherein the monitored relative distances between one or more sensors are compared to one or more threshold values to determine a type and magnitude of a mechanical device manipulation according to the teachings of Ruffaldi in order to provide efficient and reliable methods to determine functional integrity of surgical tools [see [0007] of Ruffaldi]
Regarding claim 16, Hunter further discloses that detecting device manipulations includes analyzing sensor location to detect mechanical device manipulations including flexing and/or bending of the insertable medical device. [see [0019] disclosing that different types of sensors can detect bending, cracking, breaking of the device
Regarding claim 17, Hunter further discloses that the system is further configured to measure time of use of the insertable medical device, wherein determining whether the medical device may be reprocessed for subsequent use is further based on the time of use of the insertable medical device. [see claims 49-50 and [0026]-[0027] discloses that the integrity of the device is determined over time]
Regarding claim 19, Hunter further discloses that determining whether the insertable medical device may be reprocessed includes calculating a total usage capability of the insertable medical device.[see [0435] disclosing that “Movement between the internal (implanted) sensors and external sensors can be utilized to assess whether anatomical segments have become misaligned, and whether such misalignment might need to be adjusted or corrected in a further procedure” which indicates that the location of various sensors are compared with respect to other ones]
Regarding claim 20, Hunter further discloses that detecting device manipulations during the procedure includes identifying the procedure performed with the insertable medical device by determining at least one of: a path of the insertable medical device; or an overall geometry assumed by the insertable medical device during the procedure; [see [0644] disclosing that the plurality of sensors on the medical device can “provide information on the size, shape, integrity, alignment and location of changes to the medical device, and/or medical device movement/migration. In particular, as noted above the image data can be collected over time, in order to visually show changes (e.g., a “movie” or ‘moving images”, which may be in 2D or 3D”]
Claims 4, 11, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Hunter et al. (U.S. Publication No. 2020/0281471) hereinafter “Hunter” in view of in view of Ruffaldi et al. (U.S. Publication No. 2024/0227191) hereinafter “Ruffaldi” as applied to claim 1 above and further in view of Hauck et al. (U.S. Publication No. 2017/0000381) hereinafter “Hauck”.
Regarding claim 4, Hunter in view of Ruffaldi discloses all the limitations of claim 1 [see rejection of claim 1]
Hunter further discloses that the insertable medical device is includes a curve [see FIG. 21; the device is a kyphoplasty balloon including a curved section (i.e. balloon)] and including one or more sensors located on a loop portion of the distal end, [see [0379] of Hunter] and wherein sensor location of each sensor is analyzed to detect at least one of: opening or closing of the loop; [see [0379] disclosing: “ Position sensors and location markers are also useful to monitor the expansion of the vertebral body (by, for example monitoring the position of the balloon walls as the balloon is progressively inflated) to achieve a more precise expansion”] engagement of the loop against tissue; [see [0379] disclosing: “ISMs containing contact sensors can also be placed on or within the kyphoplasty balloon in order to monitor contact between the balloon and the cancellous bone of the vertebral body”] or deployment and retraction of the loop from within an introducer.
Hunter in view of Ruffaldi does not disclose that the curved device is a loop catheter.
Hauk, directed towards providing location information sensors on a loop catheter [see abstract of Hauk] further discloses that the curved device [see FIG. 2 and [0029]; the catheter 20 is a loop catheter] including multiple position sensors is a loop catheter. [see [0024] and [0027] of Hauk]
It would have been obvious to a person of ordinary skill level in the art at the time of the filing of the invention to modify the curved device of Hunter in view of Ruffaldi and make it a loop catheter in order to locate each portion of the loop catheter and track its operation. [see [0006] of Hauk]
Regarding claim 11, Hunter in view of Ruffaldi discloses all the limitations of claim 10 [see rejection of claim 10]
Hunter further discloses that the medical device is a curved device[see FIG. 21; the device is a kyphoplasty balloon including a curved section (i.e. balloon)] including a first sensor located on a loop portion of the loop catheter [see [0379] of Hunter], wherein a location of the first sensor located on the loop portion is utilized to determine whether the loop is open or closed[see [0379] disclosing: “ Position sensors and location markers are also useful to monitor the expansion of the vertebral body (by, for example monitoring the position of the balloon walls as the balloon is progressively inflated) to achieve a more precise expansion”]
Hunter in view of Ruffaldi does not disclose that the curved device is a loop catheter.
Hauk, directed towards providing location information sensors on a loop catheter [see abstract of Hauk] further discloses that the curved device [see FIG. 2 and [0029]; the catheter 20 is a loop catheter] including multiple position sensors is a loop catheter. [see [0024] and [0027] of Hauk]
It would have been obvious to a person of ordinary skill level in the art at the time of the filing of the invention to modify the curved device of Hunter in view of Ruffaldi and make it a loop catheter in order to locate each portion of the loop catheter and track its operation. [see [0006] of Hauk]
Regarding claim 12, Hunter in view of Ruffaldi and Hauk discloses all the limitations of claim 11 [see rejection of claim 11]
Hunter further discloses the curved device includes a second sensor, see [0379] of Hunter] wherein a location of the second sensor relative to the first sensor is utilized to determine whether the loop is open or closed, [see [0379] disclosing: “ Position sensors and location markers are also useful to monitor the expansion of the vertebral body (by, for example monitoring the position of the balloon walls as the balloon is progressively inflated) to achieve a more precise expansion”] wherein the second sensor is located proximal to the loop portion or on the loop portion. [see Fig. 21 of Hunter]
Hunter in view of Ruffaldi does not disclose that the curved device is a loop catheter.
Hauk, directed towards providing location information sensors on a loop catheter [see abstract of Hauk] further discloses that the curved device [see FIG. 2 and [0029]; the catheter 20 is a loop catheter] including multiple position sensors is a loop catheter. [see [0024] and [0027] of Hauk]
It would have been obvious to a person of ordinary skill level in the art at the time of the filing of the invention to modify the curved device of Hunter in view of Ruffaldi and make it a loop catheter in order to locate each portion of the loop catheter and track its operation. [see [0006] of Hauk]
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Hunter et al. (U.S. Publication No. 2020/0281471) hereinafter “Hunter” in view of Ruffaldi et al. (U.S. Publication No. 2024/0227191) hereinafter “Ruffaldi” as applied to claim 1 above and further in view of Papini (U.S. Publication No. 2021/0330213) hereinafter “Papini”.
Regarding claims 5, Hunter in view of Ruffaldi discloses all the limitations of claims 1 and 10 [see rejection of claims 1 above]
Hunter in view of Ruffaldi does not expressly disclose that the medical device is a grid array catheter including a distal end having a plurality of flexible arms each carrying one or more sensors, wherein sensor location is analyzed to detect flexing of the plurality of flexible arms.
Papini, directed towards a grid array catheter with a plurality of position sensors [see abstract of Papini] further discloses that the medical device is a grid array catheter [see [0082] of Papini] including a distal end having a plurality of flexible arms each carrying one or more sensors, [see [0097]; plurality of position sensors 220A-1, 220A-2] wherein sensor location is analyzed to detect flexing of the plurality of flexible arms. [see [0062]-[0064] and [0097]-[0099] of Papini]
It would have been obvious to a person of ordinary skill level in the art at the time of the filing of the invention to modify the design of Hunter in view of Ruffaldi such that the medical device is a grid array catheter including a distal end having a plurality of flexible arms each carrying one or more sensors, wherein sensor location is analyzed to detect flexing of the plurality of flexible arms according to the teachings of Papini in order to determine the shape of the catheter and avoid any distortion caused from wrong mechanical shape of the catheter [see [0006] of Papini]
Claim 2, 3, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Hunter et al. (U.S. Publication No. 2020/0281471) hereinafter “Hunter” in view of Ruffaldi et al. (U.S. Publication No. 2024/0227191) hereinafter “Ruffaldi” as applied to claim 1 above and further in view of Elmouelhi et al. (U.S. Publication No. 2006/0079883) hereinafter “Elmouelhi”.
Regarding claim 2, Hunter in view of Ruffaldi discloses all the limitations of claim 1 [see rejection of claim 1]
Hunter does not expressly disclose that the one or more device attributes includes at least one of: time of use of the device; or a measure of ablation activation time
Elmouelhi, directed toward detecting functionality of an ablation system [see abstract of Elmouelhi] further discloses that the one or more device attributes includes at least one of: time of use of the device; or a measure of ablation activation time. [see [0053]-[0055]; a total ablation time, or total elapsed time is used]
It would have been obvious to a person of ordinary skill level in the art at the time of the filing of the invention to modify the design of Hunter in view of Ruffaldi such that the one or more device attributes includes at least one of: time of use of the device; or a measure of ablation activation time according to the teachings of Elmouelhi in order to arrive at an accurate determination of usability of the device [see [0052] of Elmouelhi]
Regarding claim 3, Hunter in view of Ruffaldi and Elmouelhi discloses all the limitations of claim 2 [see rejection of claim 2]
Elmouelhi further discloses updating a total usage capability of the medical device based on a combination of the one or more device attributes including detected device manipulations, time of use of the device, and the measure of ablation activation time, [see [0058]-[0060] many parameters such as total activation time, number of times the device is used, etc. are considered] wherein determining whether the medical device may be reprocessed for use in a subsequent procedure is based on a comparison of the updated total usage capability to a threshold value. [see [0058]-[0060]; the time of use is compared to parameters such as maximum allowable amount of time (i.e. threshold) to determine functionality]
It would have been obvious to a person of ordinary skill level in the art at the time of the filing of the invention to modify the design of Hunter in view of Ruffaldi as modified by Elmouelhi such that a total usage capability of the medical device based on a combination of the one or more device attributes including detected device manipulations, time of use of the device, and the measure of ablation activation time, [see [0058]-[0060] many parameters such as total activation time, number of times the device is used, etc. are considered] wherein determining whether the medical device may be reprocessed for use in a subsequent procedure is based on a comparison of the updated total usage capability to a threshold value according to the teachings of Elmouelhi in order to arrive at an accurate determination of usability of the device [see [0052] of Elmouelhi]
Regarding claim 18, Hunter in view of Ruffaldi discloses all the limitations of claim 17 [see rejection of claim 17]
Hunter in view of Ruffaldi does not expressly disclose that the system is further configured to measure ablation time of the medical device, wherein determining whether the medical device may be reprocessed for subsequent use is further based on the ablation time of the medical device.
Elmouelhi, directed towards ablation system [see abstract of Elmouelhi] further discloses that the system is further configured to measure ablation time of the medical device, wherein determining whether the medical device may be reprocessed for subsequent use is further based on the ablation time of the medical device. [see [0052] of Elmouelhi]
It would have been obvious to a person of ordinary skill level in the art at the time of the filing of the invention to modify the design of Hunter in view of Ruffaldi such that the system is further configured to measure ablation time of the medical device, wherein determining whether the medical device may be reprocessed for subsequent use is further based on the ablation time of the medical device according to the teachings of Elmouelhi in order to determine the integrity of the device for further use [see [0052] of Elmouelhi]
Response to Arguments
Applicant's arguments filed 07/1/6/2025 have been fully considered but they are not persuasive.
Rejection of claims under U.S.C., 102 and 103
Applicant’s arguments with respect to claim(s) 1 and 15 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
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARJAN - SABOKTAKIN whose telephone number is (303)297-4278. The examiner can normally be reached M-F 9 am-5pm CT.
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/MARJAN SABOKTAKIN/Examiner, Art Unit 3797
/MICHAEL J CAREY/Supervisory Patent Examiner, Art Unit 3795