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 .
Status of Claims
This action is in reply to the present application filed on March 2nd, 2026.
Claims 1, 7, 15, and 25 have been amended.
Claims 1-25 and 28 are currently pending and have been examined.
This action is made final.
Information Disclosure Statement
The information disclosure statement filed on 3/11/2026 is being considered by the Examiner.
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 1-25 and 28 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 Analysis:
Independent Claims 1 and 25 are directed to a system and method respectively and therefore fall into one of the four statutory categories. Dependent Claims 2-24 recite a system, and Claim 28 recites a method, and therefore the dependent claims also fall into one of the four statutory categories.
Step 2A Analysis – Prong One:
The substantially similar independent system and method claims, taking Claim 1 as exemplary, recite the following:
A system for automatically recommending medical devices for vascular access, comprising: an ultrasound probe;
a console operably coupled to the ultrasound probe, the console including: one or more processors;
memory including instructions configured to instantiate one or more processes when executed by the one-or-more processors, the one-or-more processes including:
automatically recommending a medical device for vascular access in accordance with a plurality of data inputs, various operating parameters, or a combination thereof,
using at least logic algorithms, machine learning, artificial intelligence, or a combination thereof;
tracking placement of the medical device while the medical device is being placed by a clinician in a vasculature of a patient; and
confirming the placement of the medical device after the medical device is placed by the clinician in the vasculature of the patient,
the various operating parameters including system-evaluated post-placement evaluations as a measure of clinician proficiency for medical-device placement;
and a display screen optionally integrated into the console, the display screen configured to display: an ultrasound image including one or more blood vessels below a skin surface of the patient;
the medical device recommended for vascular access of the one-or-more blood vessels in the ultrasound image;
and on-screen indicators differentiating veins from arteries in the vasculature of the patient as well as an on-screen indicator identifying the medical device in the vasculature of the patient while the medical device is being placed by the clinician in the vasculature of the patient.
The series of steps as shown in underline above, given the broadest reasonable interpretation, cover the abstract idea of certain methods of organizing human activity because they recite managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions – in this case, recommending a medical device for vascular access in accordance with data inputs and/or operating parameters, tracking placement of the medical device, confirming the placement of the medical device, and providing an indicator identifying the medical device in the vasculature while it is being placed) e.g. see MPEP 2106.04(a)(2). Any limitations not identified as part of the abstract idea are deemed “additional elements” and will be discussed in further detail below.
Dependent Claims 2-13, 16-24 and 28 include other abstract limitations. For example, Claim 2 recites the plurality of data inputs are automatically determined, Claim 3 recites data inputs are selected from blood-vessel size, blood-vessel location, blood-vessel cross section, blood-vessel thickness, and difficulty in blood-vessel access, Claim 4 recites the blood-vessel location includes a determination of a distance from a lens of the ultrasound probe to a top of a blood vessel, a bottom of the blood vessel, or both, Claim 5 recites a largest distance between the lens of the ultrasound probe and the bottom of the blood vessel is a determination parameter, Claim 6 recites the a determination of whether a blood vessel is visible, palpable, torturous, valvular, or a combination, Claim 7 recites automatically guiding optimum blood-vessel size, differentiating between veins from arteries, or both, Claim 8 recites detecting a needle guide and presetting an angle of insertion for the needle guide, Claim 9 recites the plurality of patient condition parameters including temperature, blood pressure, blood oxygenation, pH, lactate concentration, glucose levels, or a combination, Claim 10 recites operating parameters include confirmation of clinician training, Claim 11 recites only clinicians having the confirmation of the clinician training are allowed to use the system to place the medical device for vascular access, Claim 12 recites displaying one or more alternative clinicians allowed to use the system in view of the one-or-more alternative clinicians having the confirmation of the clinician training, Claim 13 the clinician messaging with recommendations for the one-or-more alternative clinicians allowed to use the system is in view of clinician proficiency, Claim 16 recites data inputs include procedure type, one or more clinical rules, clinician experience, one or more clinician preferences, one or more orders for specific medical devices, one or more medical device-trajectory parameters, patient condition, emergent indication, difficulty in blood-vessel access, one or more orders for specific medications, one or more infusion-therapy parameters, one or more imaging parameters, and/or dwell time, Claim 17 recites clinical rules include purchase length for the medical device, blood-vessel occupancy of the medical device, or both when the medical device is a catheter, Claim 18 recites the medical device-trajectory parameters include an insertion angle, a needle-guide configuration, or both when the medical device is a needle, Claim 19 recites the infusion-therapy parameters include fluid replacement, potassium, heparin, insulin, one or more antibiotics, one or more vesicants, one or more irritants, blood, one or more blood products, pain medication, power- injection and/or parameters, Claim 20 recites the one-or-more imaging parameters include at least an intention for power injection, Claim 21 recites the procedure type includes at least an intention for blood aspiration, Claim 22 recites a determination of whether a blood vessel is visible, palpable, torturous, and/or valvular, Claim 23 recites the patient condition includes blood pressure, hydration, nutrition, and/or temperature, Claim 24 recites the clinician experience includes clinician training or proficiency for placing the medical device for vascular access or clinician proficiency for placing the medical device, Claim 28 recites the evaluating of the placement of the medical device contributes to assessing clinician proficiency for medical device placement. These limitations only serve to further narrow the abstract idea set forth in the independent claims, and a claim may not preempt abstract ideas, even if the judicial exception is narrow, see MPEP 2106.04. Additionally, any limitations not addressed above are deemed additional elements to the abstract idea and will be further addressed above. Hence, the dependent claims are thus further directed toward fundamentally the same abstract idea as independent Claims 1 and 25.
Step 2A Analysis – Prong Two:
Claims 1 and 25 are not integrated into practical application because the additional elements (i.e. the non-underlined limitations above – in this case, the ultrasound probe, memory, processor, console, logic algorithm, machine learning, artificial intelligence, and a display screen of Claim 1, and the ultrasound probe, memory, processor, console, and a display screen of Claim 25) are recited at a high level of generality (i.e. as a generic processor performing generic computer functions) such that they amount to no more than mere instructions to apply the exceptions using generic computer components. For example, Applicant’s specification explains that as hardware, logic can refer to circuitry having data-processing or storage functionality. Examples of such circuitry include, but are not limited to, a hardware processor (e.g., a microprocessor, one or more processor cores, a digital-signal processor, a programmable gate array ["PGA"], a microcontroller, an application specific integrated circuit ["ASIC"], etc.), semiconductor memory, or the like (see applicant’s specification, ¶ 0041). The ultrasound image- displaying step includes displaying on a display screen optionally integrated into the console (see applicant’s specification, ¶ 0027). As to automatic input of the plurality of data inputs 116 into the system 100, the plurality of data inputs 116 can be automatically determined by the system 100 by way of the logic 122, the algorithms, the machine learning 124, the artificial intelligence 126, or the combination thereof such as from ultrasound imaging with the system 100 [0051]. Accordingly, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea.
Further, the additional element of the ultrasound probe is considered to merely generally link the abstract idea to a particular technological field environment or field of use. For example, Applicant’s specification explains that the ultrasound probe 106 can include a probe head 136 housing an array of ultrasonic transducers, wherein the ultrasonic transducers are piezoelectric ultrasonic transducers or capacitive micromachined ultrasonic transducers [0057]. MPEP 2106.04(d)(1) indicates that generally linking an abstract idea to a particular technological environment or field of use cannot provide a practical application. Accordingly, these additional elements do not integrate the abstract idea into a practical application. Therefore, independent Claims 1 and 25 are directed to an abstract idea without practical application.
Dependent Claims 2, 4-5, 7-8, and 10-12, and 14-16 recite additional elements, but these limitations amount to no more than mere instructions to apply an exception. Claim 2 recites the previously recited system, logic algorithm, machine learning, and artificial intelligence and specifies the data inputs are automatically determined by the system by way of the logic, algorithms, machine learning, and/or AI. Claim 4 recites the previously recited ultrasound probe and specifies the blood-vessel location includes a determination of the distance from a lens of the probe to the top or bottom of a blood vessel. Claim 5 recites the previously recited ultrasound probe and specifies the largest distance between the lens of the ultrasound probe and the bottom of the blood vessel is a determination parameter. Claim 7 recites the previously recited algorithms and specifies the algorithms, machine learning, and/or artificial intelligence are configured to automatically guide optimum blood-vessel size and/or differentiating veins from arteries. Claim 8 recites the previously recited algorithms and specifies the algorithms, machine learning, and/or artificial intelligence automatically detect a needle guide and presetting an angle insertion for the needle guide. Claim 10 recites the previously recited display screen as well as a new element of a training module and specifies the parameters include confirmation of clinician training via completion of one or more on-board training modules, the display screen further displaying clinician messaging. Claim 11 recites the previously recited system and specifies only clinicians having confirmation of the clinician training are allowed to use the system to place the devices. Claim 12 recites the previously recited display screen and system and specifies the screen displays the clinician messaging with recommendations for alternative clinicians who can use the system to place the medical device. Claim 14 recites the previously recited system and new elements of an electronic medical-care-facility system and electronic medical records and specifies the plurality of data inputs are automatically pulled into the system by way of an electronic medical-care-facility system, which includes access to patient data via EMR. Claim 15 recites the previously recited elements of an electronic medical-care-facility system and electronic medical records and specifies the electronic medica-care-facility system or the electronic medical records for the patients includes orders for specific medical devices and/or specific medications. Claim 16 recites the previously recited system and specifies the data inputs are input into the system by a clinician using the system. However, these additional elements are used in their expected fashion, so they do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on the abstract idea. These limitations amount to no more than mere instructions to apply an exception, and hence, do not integrate the aforementioned abstract idea into practical application.
Step 2B Analysis:
The claims, when considered individually or in combination, do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to the integration of the abstract idea, the additional elements the ultrasound probe, memory, processor, console, logic algorithm, machine learning, artificial intelligence, and a display screen of Claim 1, and the ultrasound probe, memory, processor, console, and a display screen of Claim 25 amount to no more than mere instructions to apply the exception using generic computer components. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept ("significantly more’). MPEP2106.05(I)(A) indicates that merely saying "apply it” or equivalent to the abstract idea cannot provide an inventive concept ("significantly more").
Also, as discussed above with respect to integration of the abstract idea into a practical application, the additional element of the ultrasound probe was considered to generally link the abstract idea to a particular technological environment or field of use. This has been re-evaluated under the ‘significantly more’ analysis and has been found insufficient to provide significantly more. MPEP2106.05 (A) indicates that generally linking an abstract idea to a particular technological environment or field of use cannot provide an inventive concept (‘significantly more"). Accordingly, even in combination, this additional element does not provide significantly more. As such the independent Claims 1 and 25 are not patent eligible.
Dependent Claims 3, 6, 9, 13, 17-24 and 28 further narrow the abstract idea and do not provide an inventive concept or additional elements. Claim 3 recites data inputs are selected from blood-vessel size, blood-vessel location, blood-vessel cross section, blood-vessel thickness, and difficulty in blood-vessel access, Claim 6 recites the a determination of whether a blood vessel is visible, palpable, torturous, valvular, or a combination, Claim 9 recites the plurality of patient condition parameters including temperature, blood pressure, blood oxygenation, pH, lactate concentration, glucose levels, or a combination, Claim 13 the clinician messaging with recommendations for the one-or-more alternative clinicians allowed to use the system is in view of clinician proficiency, Claim 17 recites clinical rules include purchase length for the medical device, blood-vessel occupancy of the medical device, or both when the medical device is a catheter, Claim 18 recites the medical device-trajectory parameters include an insertion angle, a needle-guide configuration, or both when the medical device is a needle, Claim 19 recites the infusion-therapy parameters include fluid replacement, potassium, heparin, insulin, one or more antibiotics, one or more vesicants, one or more irritants, blood, one or more blood products, pain medication, power- injection and/or parameters, Claim 20 recites the one-or-more imaging parameters include at least an intention for power injection, Claim 21 recites the procedure type includes at least an intention for blood aspiration, Claim 22 recites a determination of whether a blood vessel is visible, palpable, torturous, and/or valvular, Claim 23 recites the patient condition includes blood pressure, hydration, nutrition, and/or temperature, Claim 24 recites the clinician experience includes clinician training or proficiency for placing the medical device for vascular access or clinician proficiency for placing the medical device, Claim 28 recites the evaluating of the placement of the medical device contributes to assessing clinician proficiency for medical device placement.
Claims 2, 4-5, 7-8, 11-12, and 15-16 recite previously recited additional elements, which are not eligible for the reasons stated above, and further narrow the abstract idea. Claim 2 recites the previously recited system, logic algorithm, machine learning, and artificial intelligence and specifies the data inputs are automatically determined by the system by way of the logic, algorithms, machine learning, and/or AI. Claim 4 recites the previously recited ultrasound probe and specifies the blood-vessel location includes a determination of the distance from a lens of the probe to the top or bottom of a blood vessel. Claim 5 recites the previously recited ultrasound probe and specifies the largest distance between the lens of the ultrasound probe and the bottom of the blood vessel is a determination parameter. Claim 7 recites the previously recited algorithms and specifies the algorithms, machine learning, and/or AI are configured to automatically guide optimum blood-vessel size and/or differentiating between veins and arteries. Claim 8 recites the previously recited algorithms and specifies the algorithms, machine learning, and/or artificial intelligence automatically detect a needle guide and presetting an angle insertion for the needle guide. Claim 11 recites the previously recited system and specifies only clinicians having confirmation of the clinician training are allowed to use the system to place the devices. Claim 12 recites the previously recited display screen and system and specifies the screen displays the clinician messaging with recommendations for alternative clinicians who can use the system to place the medical device. Claim 15 recites the previously recited elements of an electronic medical-care-facility system and electronic medical records and specifies the electronic medica-care-facility system or the EMRs for the patients includes orders for specific medical devices and/or specific medications. Claim 16 recites the previously recited system and specifies the data inputs are input into the system by a clinician using the system.
Claims 10 and 14 recite new additional elements. Claim 10 recites the previously recited display screen as well as a new element of a training module and specifies the parameters include confirmation of clinician training via completion of one or more on-board training modules, the display screen further displaying clinician messaging. Claim 14 recites the previously recited system and new elements of an electronic medical-care-facility system and electronic medical records and specifies the plurality of data inputs are automatically pulled into the system by way of an electronic medical-care-facility system, which includes access to patient data via EMR. Hence, Claims 2-24 and 28 do not include any additional elements that amount to “significantly more” than the judicial exception.
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 does not add anything that is already present when looking at the elements taken individually, and there is no indication that the combination of elements improves the functioning of 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 1-25 and 28 are nonetheless rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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.
Claims 1-4, 6-7, 9, 14-17, 21-25, and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Golan et al. (US 20220406460 A1) in view of Andersen et al. (US 20240416077 A1), Jesneck et al. (US 20240249831 A1), and Dhatt et al. (US 20240156429 A1).
Regarding Claim 1, Golan discloses the following:
A system for automatically recommending medical devices for vascular access, comprising: (Golan discloses making an automatic recommendation of a device for surgery (e.g., automatically selecting a catheter type or size based on a set of machine learning models);…[0020]. As shown in FIG. 1, a system 100 for computer-aided decision guidance includes and/or interfaces with a computing system [0023].)
an ultrasound probe; a console operably coupled to the ultrasound probe, the console including: one or more processors; (Golan discloses the system 100 can optionally include and/or interface with a router 110…, which functions to receive data (e.g., a dataset) to process…The data can optionally include images…[0033]. The router 110 is preferably configured to receive data (e.g., instances, images, study, series, etc.) from a data collection device (e.g., … an imaging modality [e.g., …ultrasound machine,…etc.] [0037].)
memory including instructions configured to instantiate one or more processes when executed by the one-or-more processors, the one-or-more processes including: (Golan discloses the instructions can be executed by computer-executable components integrated with the computer-readable medium and/or processing system. The computer-readable medium may include any suitable computer readable media such as RAMs, ROMs, flash memory,…optical devices (CD or DVD), hard drives, floppy drives, non-transitory computer readable media, or any suitable device. The computer-executable component can include a computing system and/or processing system (e.g., …remote or local processors)…[0140].)
the one-or-more processes including automatically recommending a medical device for vascular access in accordance with a plurality of data inputs, various operating parameters, or a combination thereof, (Golan discloses making an automatic recommendation of a device for surgery (e.g., automatically selecting a catheter type or size based on a set of machine learning models); automatically triggering the selection of a device for surgery (e.g., automatically messaging a surgical technologist to prepare a device for surgery) [0020]. S240 includes automatically recommending a catheter for the removal of a clot, wherein the particular catheter is determined based on a set of vessel diameters (e.g., narrowest part of vessel; diameter immediately before the clot; diameters of vessels at the ICA, MCA, M2, etc.) and/or any other information [0120].)
using at least logic, algorithms, machine learning, or a combination thereof; (Golan discloses the method includes: receiving a set of … images; processing the set of images with a set of trained (e.g., machine learning, deep learning, etc.) models and/or algorithms to segment a set of vessels from the set of images; analyzing the segmented vessels to determine a set of diameters associated with the segmented vessels and/or any other regions associated with the images; …to select a recommended device…[0125].)
and a display screen optionally integrated into the console, the display screen configured to display: an ultrasound image including one or more blood vessels below a skin surface of the patient; (Golan discloses the imaging modalities can include, …ultrasound… the set of images show a brain and/or a brain region of the user, but can additionally or alternatively be associated with any other anatomical regions [0071]. The system 100 includes a mobile device application 130 and a workstation application 130…can be used to connect the applications (e.g., retrieve a case, image set, etc.) and determine the information to be displayed at each application (e.g., variations of image datasets)…the information to be displayed (e.g., compressed images, high-resolution images, etc.) can be determined…[0056, see also Fig. 5A-B which shows a display of blood vessels in the brain].)
and the medical device recommended for vascular access of the one-or-more blood vessels in the ultrasound image. (Golan discloses S240 can additionally include automatically messaging one or more users (e.g., at the client application) with this recommendation and/or automatically placing an order for the device [0120].)
Golan does not disclose tracking and confirmation of the medical device which is met by Andersen:
tracking placement of the medical device while the medical device is being placed by a clinician in a vasculature of a patient; (Andersen teaches various multi-model vascular access placement systems can be used to locate, track, and confirm placement of a catheter or similar VAD at a target location within a patient [0001]. One or both of the sensor 90 and the multi-modal tracking system 80 can detect a magnetic field strength of the magnetic element 180 to track a location of the distal tip 164 of the catheter 160 as it travels through the vasculature towards the target location [0044].)
and confirming the placement of the medical device after the medical device is placed by the clinician in the vasculature of the patient, (Andersen teaches as the distal tip 164 of the catheter 160 approaches a target location, the system 100 can detect an ECG signal at the distal tip 164 of the catheter 160 to confirm a position thereof relative to the target location with much higher accuracy that can be achieved with the magnetic tracking modality. The system 100 can provide one or more electrical pathways to provide the ECG signal to the multi-modal tracking system 80. ECG signals from two or more electrical pathways can be cross-referenced confirm accuracy of placement, and maintain a consistent ECG signal during the placement procedure [0044].)
system-evaluated post-placement evaluations… for medical-device placement (Anderson teaches a console configured to compare one of the first ECG signal and the second ECG signal to determine an accuracy of a location of the distal tip of the catheter [0044].)
…while the medical device is being placed by the clinician in the vasculature of the patient. (Anderson teaches multi-modal vascular access placement systems can be used to locate, track, and confirm placement of a catheter or similar VAD at a target location within a patient [0001].)
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the systems and methods for the automatic recommendation of a medical device for vascular access by using an ultrasound and a display screen as disclosed by Golan to incorporate the tracking and placement of the medical device as taught by Andersen. This modification would ensure the efficacy of the treatment and to prevent undue trauma to the patient (see Andersen, ¶ 0001).
Golan and Andersen do not teach a evaluating a measure of clinician proficiency which is met by Jesneck:
the various operating parameters including system-evaluated post-… evaluations as a measure of clinician proficiency…; (Jesneck teaches a data management platform for determining a competency score for a…healthcare progressional, the platform comprising:…calculating a competency score [skill score] for the target healthcare progressional for the procedure….[0019-0025]. The level of skill or competency of the healthcare professional can be characterized according to either continuous or ordinal scales, for example, the following three levels: i. Competent: the minimum skill required of a practitioner to perform the procedure independently ii. Proficient: a higher level of skill, indicating that the practitioner is capable of performing the procedure efficiently and with better outcomes [0133] iii. Mastery: the highest level of skill,…[0130-0133].)
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the systems and methods for the automatic recommendation of a medical device for vascular access which uses technology to assist physicians as disclosed by Golan to incorporate evaluating the performance of the clinician as an identification of clinician proficiency as taught by Jesneck. This modification would create a system and methods which can objectively and timely provide performance evaluation about how well trained and proficient a doctor is with performing a specific medical procedure (see Jesneck, ¶ 0007).
Golan, Andersen, and Jesneck do not teach a on screen indicators which is met by Dhatt:
and on-screen indicators differentiating veins from arteries in the vasculature of the patient (Dhatt teaches particular organizations of arteries and veins can be detected as a unified structure. For example, a triad is a vein-artery-vein collection where a central artery is closely bounded on either side by a vein. In one example, the AI can distinctly detect and classify the veins and arteries in the triad as individual components [0045].)
as well as an on-screen indicator identifying the medical device in the vasculature of the patient…(Dhatt teaches the ultrasound system includes an image module that generates one or more ultrasound images based on ultrasound echo signals, a neural network module and a processor(s) that operate together to perform blood vessel identification and/or generate and display guidance information for instrument insertion, …the instrument can be a catheter, needle or another medical tool [0128]. The process includes processing logic determining diameters and depths of the blood vessels (processing block 1926) and determining, for a blood vessel of the blood vessels, a threshold insertion length of a catheter to be inserted into the blood vessel based on a diameter of the blood vessel (processing block 1927). The threshold insertion length indicates an amount of the catheter inside the blood vessel [0156, see also Fig. 20A].)
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the systems and methods for the automatic recommendation of a medical device for vascular access which uses technology to assist physicians as disclosed by Golan to incorporate the use of on-screen indicators for veins, arteries, and the device as taught by Dhatt. This modification would create a system which aids in minimizing clinician error in catheterization (see Dhatt, ¶ 0004-5).
Regarding Claim 25, this claim recites substantially similar limitations to that of Claim 1 above; thus, the same rejection applies. Golan further discloses:
a method of a system for automatically recommending a medical device for vascular access…(Golan discloses as shown in FIG. 2, a method 200 for computer aided decision guidance includes: receiving a set of data S210; determining a set of parameters associated with the set of data S230; and triggering an output based on the set of parameters S230 [0060].)
Regarding Claim 2, Golan, Andersen, Jesneck, and Dhatt teach the limitations as shown in the rejection of Claim 1 above. Golan further discloses:
the plurality of data inputs are automatically determined by the system by way of the logic, the algorithms, the machine learning, the artificial intelligence, or the combination thereof. (Golan discloses any or all of the information can be determined with artificial intelligence (AI), such as a with any or all of: a set of machine learning models and/or algorithms, a set of deep learning models and/or algorithms (e.g., neural networks, convolutional neural networks, etc.), a set of mappings, a decision tree, and/or with any other tools [0042]. The method 200 can include determining a set of parameters associated with the set of data S230…[0090]. The set of parameters determined in S230 can include any or all of: vessel diameters…[0096]. The set of parameters is preferably at least partially determined automatically, such as with a set of models (e.g., trained models, machine learning models, deep learning models, etc.) [0093].)
Regarding Claim 3, Golan, Andersen, Jesneck, and Dhatt teach the limitations as shown in the rejection of Claim 1 above. Golan further discloses:
plurality of data inputs are selected from blood-vessel size, blood-vessel location, blood-vessel cross section, blood-vessel thickness, and difficulty in blood-vessel access. (Golan discloses in variations involving vasculature, such as vessels in the brain, the set of parameters can include, for instance, one or more vessel diameters, such as any or all of: a vessel diameter immediately before (e.g., proximal and adjacent to) an occlusion or other landmark (e.g., along a path that the surgeon would take with a catheter); a diameter of the narrowest part of a vessel needed to reach the occlusion or other landmark; a total length of the vessels needed to reach the occlusion or other landmark [0096].)
Regarding Claim 4, Golan, Andersen, Jesneck, and Dhatt teach the limitations as shown in the rejection of Claim 3 above. Golan, Andersen, and Jesneck do not teach the following limitations met by Dhatt:
wherein the blood-vessel location includes a determination of a distance from a lens of the ultrasound probe to a top of a blood vessel, a bottom of the blood vessel, or both. (Dhatt teaches the ultrasound machine determines a desired entry point for an interventional instrument. The ultrasound machine can then calculate the distance from a transducer face (e.g., an edge of a probe) to the desired entry point, and display an indicator of the distance on a display of the ultrasound machine [0049]. A point of a blood vessel is tracked between frames, and the ultrasound system measures movement of the point. In the case of a point, the information related to the point may include a center, a top, a bottom, a left, a right, or a centroid point of a blood vessel region, and the difference in location of the same point between two ultrasound images is evaluated [0064].)
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the systems and methods for the automatic recommendation of a medical device for vascular access as disclosed by Golan to incorporate measuring the distance between either the top or bottom of the vessel and the ultrasound probe as taught by Dhatt. This modification would create a system and methods which would allow the clinician to easily identify the location of the blood vessel and improve the time it takes to effectively insert a device into the blood vessel (see Dhatt, ¶ 0003-5).
Regarding Claim 6, Golan, Andersen, Jesneck, and Dhatt teach the limitations as shown in the rejection of Claim 3 above. Golan further discloses:
the difficulty in blood-vessel access includes a determination of whether a blood vessel is visible, palpable, torturous, valvular, or a combination thereof; (Golan discloses the set of parameters can include…one or more parameters associated with the tortuosity of the vessels (e.g., sharpest angle along a proposed path for reaching an occlusion, average tortuosity of the vessel(s), etc.); and/or any other parameters [0096].)
Regarding Claim 7, Golan, Andersen, Jesneck, and Dhatt teach the limitations as shown in the rejection of Claim 2 above. Golan, Andersen, and Jesneck do not teach the following limitations met by Dhatt:
wherein the logic, the algorithms, the machine learning, the artificial intelligence, or the combination thereof are further configured for automatically guiding optimum blood-vessel size, differentiating between the veins from arteries, or both. (Dhatt teaches an ultrasound system for identifying blood vessels includes an image module to generate one or more ultrasound images based on ultrasound echo signals, and a neural network module to identify the blood vessels in the one or more ultrasound images and assign one of a vein classification or an artery classification to each blood vessel of the blood vessels [0009].)
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the systems and methods for the automatic recommendation of a medical device for vascular access as disclosed by Golan to incorporate the system’s ability to differentiate a vein from an artery as taught by Dhatt. This modification would create a system and methods which allow the clinician to easily identify the target blood vessel and improve the time it takes to effectively insert a device into the blood vessel (see Dhatt, ¶ 0003-5).
Regarding Claim 9, Golan, Andersen, Jesneck, and Dhatt teach the limitations as shown in the rejection of Claim 1 above. Golan further discloses:
wherein automatically recommending the medical device for vascular access is further in accordance with a plurality of patient condition parameters input by an input device, (Golan discloses S210 includes retrieving a set of inputs, such as retrieving historical information (e.g., prior imaging studies), demographic information, medical information (e.g., from medical records), and/or any other information associated with a patient [0074]. S210 includes receiving a set of signals (.e.g. ECG signals, heart rate signals, etc.) from a signal collection device [0077, Fig. 8]. The Examiner interprets receiving a set of patient-specific signals as receiving patient condition parameters input from an input device.)
the plurality of patient condition parameters including temperature, blood pressure, blood oxygenation, pH, lactate concentration, glucose levels, or a combination thereof. (Golan discloses S210 includes receiving a set of signals (e.g., ECG signals, heart rate signals, etc.) from a signal collection device (e.g., ECG signal collection device, heart rate monitor, blood pressure cuff, vital signs monitor, etc.) [0077].)
Regarding Claim 14, Golan, Andersen, Jesneck, and Dhatt teach the limitations as shown in the rejection of Claim 1 above. Golan further discloses:
the plurality of data inputs are automatically pulled into the system by way of an electronic medical-care-facility system, which, in turn, optionally includes access to patient data via electronic medical records for patients. (Golan discloses the set of data is preferably received at a computing system from any or all of: a router, a set of applications… another computing system and/or database [0070]. The set of inputs can further additionally or alternatively include any inputs received from a user (e.g., specialist, device representative, etc.) at the application …inputs received from a database (e.g., EMR, EHR, etc.), and/or any other inputs [0075]. The set of parameters is preferably at least partially determined automatically, such as with a set of models (e.g., trained models, machine learning models, deep learning models, etc.) and/or algorithms (e.g., as utilized in S220),…[0093].)
Regarding Claim 15, Golan, Andersen, Jesneck, and Dhatt teach the limitations as shown in the rejection of Claim 1 above. Golan further discloses:
the electronic medical-care-facility system or the electronic medical record for the patients includes orders for specific medical devices, specific medications, or a combination thereof (Golan discloses S240 is performed with a computing system [0167]. S240 can optionally additionally or alternatively include triggering any other actions such as,… the automatic ordering of a medical device [0118].)
Regarding Claim 16, Golan, Andersen, Jesneck, and Dhatt teach the limitations as shown in the rejection of Claim 1 above. Golan further discloses:
the plurality of data inputs are manually input into the system by the clinician using the system, (Golan discloses the set of inputs can further additionally or alternatively include any inputs received from a user (e.g., specialist, device representative, etc.) at the application (e.g., as described above, as described below, etc.), inputs received from a database (e.g., EMR, EHR, etc.), and/or any other inputs [0075]. A user herein refers to anyone using the system and/or interfacing with the method, such as… specialist (e.g., neurovascular specialist,… oncologist, surgeon, etc.) [0031].)
the plurality of data inputs including procedure type, one or more clinical rules, clinician experience, one or more clinician preferences, one or more orders for specific medical devices, one or more medical device-trajectory parameters, patient condition, emergent indication, difficulty in blood-vessel access, one or more orders for specific medications, one or more infusion-therapy parameters, one or more imaging parameters, dwell time, or a combination thereof. (Golan discloses the set of inputs can additionally or alternatively include any other inputs, such as other patient information … specialist information (e.g., preferences, specialty, procedures the specialist is qualified and/or certified to perform, procedures the specialist prefers performing and/or is most qualified performing, on-call schedule, etc.,), device information (e.g.., device handbooks, device specifications, device parameters such as size parameters, device inventory at a particular healthcare facility, etc.,), device representative information (e.g., contact information, availability, location, etc.), and/or any other suitable information [0073]. S240 can optionally additionally or alternatively include triggering any other actions such as,… the automatic ordering of a medical device [0118].)
Regarding Claim 17, Golan, Andersen, Jesneck, and Dhatt teach the limitations as shown in the rejection of Claim 16 above. Golan further discloses:
the one-or-more clinical rules include purchase length for the medical device, blood-vessel occupancy of the medical device, or both when the medical device is a catheter. (Golan discloses selecting the medical device can include any or all of: a type of medical device, features (e.g., size, material composition, features, etc.) of a medical device, and/or any other information. In some variations, for instance, S240 can include selecting any or all of: a catheter diameter (e.g., based on vessel diameter, based on smallest vessel diameter, based on vessel diameter immediately before the occlusion, etc.), a catheter length (e.g., based on path length, based on length of one or more vessels, etc.) [0110]. Further, S240 can include selecting a diameter of a catheter that is as large as possible while being no larger than a diameter of the narrowest part of the vessel needed to pass through to access the clot [0111].)
Regarding Claim 21, Golan, Andersen, Jesneck, and Dhatt teach the limitations as shown in the rejection of Claim 16 above. Golan further discloses:
the procedure type includes at least an intention for blood aspiration. (Golan discloses S240 can optionally include selecting (e.g., recommending, initiating, etc.) a type of procedure and/or other treatment option for the patient. In the case of an acute brain condition (e.g., stroke), for instance, this can include selecting: a procedure vs. medication-only treatment…a type of procedure (e.g.,…aspiration,…) [0108]. Selecting the medical device can include any or all of: … whether or not aspiration is involved in the procedure (e.g., based on calcification of clot), a device type (e.g., catheter, revascularization device, coil, braid, aspiration system, etc.) [0110].)
Regarding Claim 22, Golan, Andersen, Jesneck, and Dhatt teach the limitations as shown in the rejection of Claim 16 above. Golan further discloses:
the difficulty in blood-vessel access includes a determination of whether a blood vessel is visible, palpable, torturous, valvular, or a combination thereof. (Golan discloses the set of parameters can include…one or more parameters associated with the tortuosity of the vessels (e.g., sharpest angle along a proposed path for reaching an occlusion, average tortuosity of the vessel(s), etc.); and/or any other parameters [0096].)
Regarding Claim 23, Golan, Andersen, Jesneck, and Dhatt teach the limitations as shown in the rejection of Claim 16 above. Golan further discloses:
the patient condition includes blood pressure, hydration, nutrition, temperature, or a combination thereof. (Golan discloses S210 includes receiving a set of signals (e.g., ECG signals, heart rate signals, etc.) from a signal collection device (e.g., ECG signal collection device, heart rate monitor, blood pressure cuff, vital signs monitor, etc.) [0077].)
Regarding Claim 24, Golan, Andersen, Jesneck, and Dhatt teach the limitations as shown in the rejection of Claim 16 above. Golan further discloses:
The clinician experience includes clinician training or proficiency for placing the medical devices…(Golan discloses specialist information (e.g., preferences, specialty, procedures the specialist is qualified and/or certified to perform, procedures the specialist prefers performing and/or is most qualified performing, on-call schedule, etc.) [0073].)
…medical devices automatically recommended by the system for vascular access. (Golan discloses making an automatic recommendation of a device for surgery (e.g., automatically selecting a catheter type or size…); automatically triggering the selection of a device for surgery (e.g., automatically messaging a surgical technologist to prepare a device for surgery) [0020]. S240 includes automatically recommending a catheter for the removal of a clot, wherein the particular catheter is determined based on a set of vessel diameters (e.g., narrowest part of vessel; diameter immediately before the clot; diameters of vessels at the ICA, MCA, M2, etc.) and/or any other information [0120].)
Regarding Claim 28, Golan, Andersen, Jesneck, and Dhatt teach the limitations as shown in the rejection of Claim 25 above. Golan does not disclose the following limitations met by Andersen:
wherein the evaluating of the placement of the medical device… for medical-device placement (Anderson teaches a console configured to compare one of the first ECG signal and the second ECG signal to determine an accuracy of a location of the distal tip of the catheter [0044].)
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the systems and methods for the automatic recommendation of a medical device for vascular access by using an ultrasound and a display screen as disclosed by Golan to incorporate evaluating the placement accuracy of the medical device as taught by Andersen. This modification would ensure the efficacy of the treatment and to prevent undue trauma to the patient (see Andersen, ¶ 0001).
Golan and Andersen do not teach assessing clinician proficiency which is met by Jesneck:
contributes to assessing clinician proficiency. (Jesneck teaches the level of skill or competency of the healthcare professional can be characterized according to either continuous or ordinal scales, for example, the following three levels: i. Competent: the minimum skill required of a practitioner to perform the procedure independently ii. Proficient: a higher level of skill, indicating that the practitioner is capable of performing the procedure efficiently and with better outcomes [0133] iii. Mastery: the highest level of skill,…[0130-0133].)
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the systems and methods for the automatic recommendation of a medical device for vascular access which uses technology to assist physicians as disclosed by Golan to incorporate evaluating the performance of the clinician as an identification of clinician proficiency as taught by Jesneck. This modification would create a system and methods which can objectively and timely provide performance evaluation about how well trained and proficient a doctor is with performing a specific medical procedure (see Jesneck, ¶ 0007).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Golan, Andersen, Jesneck, and Dhatt in view of Urabe et al. (US 20210186467 A1).
Regarding Claim 5, Golan, Andersen, Jesneck, and Dhatt teach the limitations as shown in the rejection of Claim 4 above. Golan, Andersen, Jesneck, and Dhatt do not teach the following limitations met by Urabe:
a largest distance between the lens of the ultrasound probe and the bottom of the blood vessel is a determination parameter (Urabe teaches in a case where a measurement region has been already set or in a case where a specified position specified by a user exists when ultrasound diagnostic apparatus A (Doppler parameter setting section 12) according to the present embodiment automatically sets a measurement region in the Doppler mode, ultrasound diagnostic apparatus A sets a search condition (for example, weights or a search range) such that the measurement region is automatically set near the measurement region that has been already set or near the specified position, and then executes processing of searching for a position of a blood vessel [0099].)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the various operating parameters of Golan to include the distance between the blood vessel and the ultrasound probe being a determination parameter as taught by Urabe to advantageously recommend medical devices (e.g., catheters) that correspond to a particular distance between the probe and the target vessel. This modification would it is possible to reduce, while reflecting the intention of a user, an operation load for a user when setting a measurement region in the Doppler mode (see Urabe, ¶ 0163). A person of ordinary skill in the art would have been motivated to combine the prior art to achieve the claimed invention and there would have been a reasonable expectation of success in doing so." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). Furthermore, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Golan, Andersen, Jesneck, and Dhatt, in view of Prince et al. (US 20210085282 A1).
Regarding Claim 8, Golan, Andersen, Jesneck, and Dhatt teach the limitations as seen in the rejection of Claim 2 above. Golan, Andersen, Jesneck, and Dhatt do not teach the following limitations met by Prince:
wherein the logic, the algorithms, the machine learning, the artificial intelligence, or the combination thereof are further configured for automatically detecting a needle guide and presetting an angle of insertion for the needle guide. (Prince teaches the angle of insertion of the cannula is entered to the system 10 by the clinician…the system 10 is able to determine the angle of insertion by detecting the presence of the cannula within an angled needle guide, coupled to the ultrasound probe 12 [0049].)
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the systems and methods for the automatic recommendation of a medical device for vascular access as disclosed by Golan to incorporate the detection of the needle guide and insertion angle as taught by Prince. This modification would create a system and methods which can ensure the optimal administration of vascular-based therapies and minimizes failed attempts at vascular access (see Prince, ¶ 0002).
Claims 10-13 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Golan, Andersen, Jesneck, and Dhatt in view of Willybiro et al. (US 20200234812 A1).
Regarding Claim 10, Golan, Andersen, Jesneck, and Dhatt teach the limitations as seen in the rejection of Claim 1 above. Golan, Andersen, Jesneck, and Dhatt do not teach the following limitations met by Willybiro:
the various operating parameters include confirmation of clinician training via completion of one or more on-board training modules, the display screen further configured to display clinician messaging with the confirmation of the clinician training. (Willybiro teaches the computing device 300 may also include the clinician training module 334. The clinician training module 334 may be executed by the processor 302 to receive data regarding certificates associated with the operating clinician and off-site and real scenario training the clinician has received. Additionally, the clinician training module 334 may access the EMR database 332 to determine the medical procedures the clinician has engaged in as well as the IV catheters used on various patients by the clinician [0054]. Figure 2 illustrates how the user device/tablet includes a display of a decision tree that incorporates clinician training status. This display is interpreted as clinician messaging because it conveys a message to the clinician regarding training.)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the various operating parameters of Golan to include confirmation of clinician training via completion of one or more on-board training modules, the display screen further configured to display clinician messaging with the confirmation of the clinician training as taught by Willybiro to advantageously recommend medical devices (e.g., catheters) that correspond to a particular level of training of the clinician thereby avoiding adverse patient outcomes. This modification would create a system and methods which can verify the clinician’s ability to use certain devices (see Willybiro, ¶ 0063).
Regarding Claim 11, Golan, Andersen, Jesneck, Dhatt and Willybiro teach the limitations as shown in the rejection of Claim 10 above. Golan further discloses:
the medical devices automatically recommended by the system for vascular access (Golan discloses making an automatic recommendation of a device for surgery (e.g., automatically selecting a catheter type or size based on a set of machine learning models); automatically triggering the selection of a device for surgery [0020]. S240 includes automatically recommending a catheter for the removal of a clot, wherein the particular catheter is determined based on a set of vessel diameters (e.g., narrowest part of vessel; diameter immediately before the clot; …etc.) and/or any other information [0120].)
Golan, Andersen, Jesneck, and Dhatt do not teach the following limitations met by Willybiro:
only clinicians having the confirmation of the clinician training are allowed to use the system to place the medical devices… for vascular access (Willybiro teaches the decision tree 235 may also include data relative to the clinician's training and qualifications to use certain types of IV catheters… The clinician may have used the intravenous therapy selection system 200 to report successful achievement of certain clinical qualifications that indicate that the clinician is proficient in using a certain type of IV catheter…the decision tree 235 may include options associated with these qualifications and provide alternative IV catheters to use [0033].)
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention for only clinicians having the confirmation of the clinician training to be allowed to use the system for the automatic determination of the one-or more medical devices for vascular access in the system of Golan as taught by Willybiro. This modification would create a system and methods which can verify the clinician’s ability to use certain devices and ensure only qualified clinicians are performing procedures (see Willybiro, ¶ 0063).
Regarding Claim 12, Golan, Andersen, Jesneck, Dhatt, and Willybiro teach the limitations as shown in the rejection of Claim 11 above. Golan further discloses:
the display screen is further configured to display the clinician messaging with recommendations for one or more alternative clinicians allowed to use the system to place the medical devices automatically recommended by the system for vascular access…(Golan disclose the set of inputs can include specialist information (e.g. preferences, specialty, procedures the specialist is qualified and/or certified to perform, procedures the specialist prefers performing and/or is most qualified performing…etc.) [0073]. The method 200 functions to assist physicians…making recommendations related to… an optimal surgical team to assemble [0063].)
Golan, Andersen, Jesneck, and Dhatt do not teach the following limitation met by Willybiro:
…in view of the one-or-more alternative clinicians having the confirmation of the clinician training. (Willybiro teaches the decision tree 235 may also include data relative to the clinician's training and qualifications to use certain types of IV catheters… The clinician may have used the intravenous therapy selection system 200 to report successful achievement of certain clinical qualifications that indicate that the clinician is proficient in using a certain type of IV catheter [0033].)
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention for only clinicians having the confirmation of the clinician training to be allowed to use the system for the automatic determination of the one-or more medical devices for vascular access in the system of Golan as taught by Willybiro. This modification would create a system and methods which can verify the clinician’s ability to use certain devices and ensure only qualified clinicians are performing procedures (see Willybiro, ¶ 0063).
Regarding Claim 13, Golan, Andersen, Jesneck, Dhatt and Willybiro teach the limitations as shown in the rejection of Claim 12 above. Golan further discloses:
the clinician messaging with the recommendations for the one-or-more alternative clinicians …being further in view of the clinician proficiency (Golan discloses the set of inputs can include specialist information (e.g. preferences, specialty, procedures the specialist is qualified and/or certified to perform, procedures the specialist prefers performing and/or is most qualified performing…etc.) [0073]. The method 200 functions to assist physicians…making recommendations related to… an optimal surgical team to assemble [0063].)
Golan is silent regarding only proficient clinicians being allowed to use the system. This limitations is nevertheless taught by Willybiro:
…clinicians allowed to use the system… (Willybiro teaches the decision tree 235 may also include data relative to the clinician's training and qualifications to use certain types of IV catheters… The clinician may have used the intravenous therapy selection system 200 to report successful achievement of certain clinical qualifications that indicate that the clinician is proficient in using a certain type of IV catheter…the decision tree 235 may include options associated with these qualifications and provide alternative IV catheters to use [0033]. These qualifications may be IV catheter-specific qualifications or may be qualifications that allow or qualify the clinician 405 to use certain IV catheters on a patient and engage in other medical activities related to the patient [0063].)
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the system and methods for the recommendation of a medical device including recommending alternate clinicians for the procedure as disclosed by Golan to incorporate only proficient clinicians allowed to use the system as taught by Willybiro. This modification would create a system and methods which can verify the clinician’s ability to use certain devices and ensure only qualified clinicians are performing procedures (see Willybiro, ¶ 0063).
Regarding Claim 19, Golan, Andersen, Jesneck, and Dhatt teach the limitations as seen in the rejection of Claim 16 above. Golan, Andersen, Jesneck, and Dhatt do not teach the following limitations met by Willybiro:
the one-or-more infusion-therapy parameters include fluid replacement, potassium, heparin, insulin, one or more antibiotics, one or more vesicants, one or more irritants, blood, one or more blood products, pain medication, power-injection parameters, or a combination thereof. (Willybiro teaches catheters may be used for a variety of infusion therapies. Catheters are used for infusing fluid, such as normal saline solution, various medicaments, and total parenteral nutrition, into a patient, withdrawing blood from a patient, or monitoring various parameters of the patient's vascular system. The clinician may be presented with a patient that is to receive an IV catheter at a blood vessel in order to administer a medicament into the patient's blood stream [0030]. (Medicament infusion is interpreted as fluid replacement or medications). Further, the system provides, via a display device, an IV device recommendation based on data descriptive of a first patient and first clinician [0006].)
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention for the data inputs to include one-or-more infusion-therapy parameters including fluid replacement/medication in the system of Golan as taught by Willybiro because catheters are used for a wide variety of infusion therapies and to advantageously recommend medical devices that are more closely tailored to a type of infusion being administered and thereby avoid adverse patient outcomes. This modification would create a system and methods which can select the proper catheter based upon the procedure or treatment being conducted (see Willybiro, ¶ 0002).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Golan, Andersen, Jesneck, and Dhatt in view of Southard et al. (US 20200237403 A1).
Regarding Claim 18, Golan, Andersen, Jesneck, and Dhatt teaches the limitations as shown in the rejection of Claim 16 above. Golan, Andersen, Jesneck, and Dhatt do not teach the following limitations met by Southard:
the one-or-more medical device-trajectory parameters include an insertion angle, a needle-guide configuration, or both when the medical device is a needle. (Southard teaches an ultrasound-imaging system is configured to perform a set of operations for accessing a blood vessel, recommending a proper approach angle for approaching the blood vessel with the medical device [0050]. FIG. 10, specifically, illustrates an ultrasound image including the position and orientation of a needle. See, also, FIG. 6 for the angle of insertion θ, the depth of the blood vessel d, the distance or length from the probe 1140 to the insertion location, and known length of the needle 1200.)
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the systems and methods for the automatic recommendation of a medical device for vascular access as disclosed by Golan to incorporate the determination of the optimal insertion angle as taught by Southard. This modification would create a system and methods which can ensure the proper placement of the devices (see Southard, abstract).
Claims 20 is rejected under 35 U.S.C. 103 as being unpatentable over Golan, Andersen, Jesneck, and Dhatt in view of Krimsky et al. (US 20180036084 A1).
Regarding Claim 20, Golan, Andersen, and Jesneck teach the limitations as shown in the rejection of Claim 16 above. Golan, Andersen, and Jesneck do not teach the following limitations met by Krimsky:
the one-or-more imaging parameters include at least an intention for power injection. (Krimsky teaches the endoscopic navigation catheter 26 can be used to inject dyes or fluorescent materials at a target site enabling them to be better visualized by the clinician [0054].)
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the systems and methods for the automatic recommendation of a medical device for vascular access as disclosed by Golan to incorporate the potential use of power injection as taught by Krimsky. This modification would create a system and methods which can assist the clinician in finding the proper placement location and minimize procedure error (see Krimsky, ¶ 0003).
Relevant Prior Art of Record Not Currently Being Applied
The prior art made of record and not relied upon is considered pertinent to the applicant’s disclosure.
Southard et al. (US 20180015256 A1) teaches systems and methods for assisting with the placement of a catheter within a blood vessel using ultrasound imaging. The systems and methods utilize an automatic size comparison tool to determine optimal catheter size as well as a display to provide the clinician with a view of the ultrasound images.
Response to Arguments
Regarding objections to Claim 15, Applicant’s amendments have been considered, and the objection has been withdrawn.
Regarding rejections under 35 USC 101 to Claims 1-25 and 28, Applicant’s arguments have been considered but are not persuasive. The rejection has been updated in light of the amendments above.
Applicant argues MPEP 2106.04(d) indicates that a claim integrating elements in addition to an alleged judicial exception is patient eligible by way of Prong 2 of Step 2A if there is “an improvement in the functioning of a computer, or an improvement to other technology or technical field.” At the very least, the claimed system for automatically recommending medical devices for vascular access improves the medical field, particularly with respect to ensuring the best procedural outcomes for establishing vascular access under ultrasound. Indeed, conventional procedure for establishing vascular access under ultrasound requires a clinician to differentiate veins from arteries in an ultrasound image of a patient's vasculature before attempting vascular access with a clinician-chosen medical device. The claimed system differentiates veins from arteries with on-screen indicators and tracks the system-recommended medical device with another on-screen indicator while the medical device is being placed, thereby reducing clinician error and improving the conventional procedure with the claimed system (see Applicant’s Remarks, p. 9)
Examiner respectfully disagrees. The claims do not claim how the medical device differentiates veins from arteries, let alone in an improved manner. The claims merely display on screen indicators which show veins and arteries, but the differentiation of the two is outside of the scope of the claimed invention. The instant claims do not provide a technological solution to a technological problem because there is no technological problem present. The distributed nature of the claimed invention is not, in itself, dispositive in determining whether the claimed invention recites an abstract idea because the concept of establishing vascular access is not a technological solution to a technological problem – that is, the concept of “determining the proper medical device” has existed since long before the advent of computer technology, and thus cannot properly be considered a technological improvement and/or improvement to the computer itself. Additionally, reducing human error is not a technical problem.
Examiner notes that the recommending of a medical device does not actually mean that the recommendation is followed or implemented. There is nothing in the claims that ensures what medical device is utilized. Additionally, the placement of the medical device is claimed as being evaluated post-placement, so the invention is not preventing misplacement of a medical device.
Furthermore, the claimed solution of automatically recommending a medical device provides an automation of a process that can already be done manually. Efficiency is not enough to amount to a practical application via an improvement to computer or technology under Step 2A Prong 2 (see MPEP § 2106.05(a)(I) examples that the courts have indicated may not be sufficient to show an improvement in computer-functionality: ii. accelerating a process of analyzing audit log data when the increased speed comes solely from the capabilities of a general-purpose computer, FairWarning IP, LLC v. Iatric Sys., 839 F.3d 1089, 1095, 120 USPQ2d 1293, 1296 (Fed. Cir. 2016)) (also see MPEP § 2106.05(f)(2) stating “"claiming the improved speed or efficiency inherent with applying the abstract idea on a computer" does not provide an inventive concept (Intellectual Ventures I LLC v. Capital One Bank (USA), 792 F.3d 1363, 1367 (Fed. Cir. 2015)”), and, thus, the combination of the generic computer components do not provide a non-conventional and non-generic arrangement of known, conventional pieces; note this is applied to Step 2B as well as Step 2A Prong 2).
Regarding rejection to Claims 1-25 and 28 under 35 USC 103, Applicant’s arguments and amendments have been considered and are persuasive, therefore, the rejection has been withdrawn. However, upon further consideration, a new grounds for rejection has been made in light of the amendments, rejecting the independent claims over Golan in view of Andersen, Jesneck, and Dhatt.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLIVIA R GEDRA whose telephone number is (571)270-0944. The examiner can normally be reached Monday - Friday 8:00am-5:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Peter H Choi can be reached on (469)295-9171. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/OLIVIA R. GEDRA/Examiner, Art Unit 3681
/PETER H CHOI/Supervisory Patent Examiner, Art Unit 3681
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