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 ("RCE"), 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 March 2, 2026, has been entered.
Status of Claims
Claims 1, 2, 4-21, 23, 24, 26-29, and 31 were previously pending and subject to a Final Office Action having a notification date of December 29, 2025 (“Final Office Action”). Following the Final Office Action, Applicant filed an amendment on March 2, 2026 (“Amendment”), amending claims 1, 6-9, 28, and 31. The Amendment resulted in an Advisory Action dated March 9, 2026, indicating non-entry of the Amendment. Applicant then filed the RCE on March 26, 2026, requesting entry of the Amendment.
While the status identifier for claims 20 and 21 reads "Currently amended," these claims do not appear to have been amended.
The present non-final Office Action addresses pending claims 1, 2, 4-21, 23, 24, 26-29, and 31 in the Amendment.
Response to Arguments
Response to Applicant’s Arguments Regarding Claim Rejections Under 35 USC §101
In relation to the claim rejections under 35 USC 101 set forth in the Final Office Action, these rejections are now withdrawn when currently pending claims 1, 2, 4-21, 23, 24, 26-29, and 31 are considered in view of the 2019 Revised Patent Subject Matter Eligibility Guidance (which collectively includes the guidance in the January 7, 2019 Federal Register notice and the October 2019 update issued by the USPTO as now incorporated into the MPEP, and as supported by relevant case law) and Applicant' s remarks in the Amendment.
For instance, while independent claims 1, 28, and 31 recite certain limitations that include a “mental process” abstract idea (e.g., receiving patient condition parameters and feedback, generating/determining one or more medical devices for a vascular access including a percent likelihood of success/confidence level, etc.) because they can be practically performed in the human mind (e.g., with pen and paper), the claims recite additional limitations that amount to a “practical application” of the abstract idea and/or are “significantly more” than the abstract idea. For instance, at least the additional limitations of generating electrical signals of a vascular access with an ultrasound probe, using the electrical signals to generate an ultrasound image on a display screen, training an ML model using the electrical signals generated by the ultrasound probe during the vascular access, using the trained ML model to generate the determination of the medical device(s) for the subsequent vascular access, and using the medical device(s) for the vascular access procedure amount to other meaningful limitations beyond generally linking the use of the judicial exception to a particular technological environment. MPEP 2106.05(e). Specifically, such limitations are meaningful “because they integrate the results of the analysis into a specific and tangible method that results in the method moving from abstract scientific principles to specific application.” Id.
Claim Objections
Claims 1 and 11 are objected to because of the following informalities:
In claim 1, line 9, it appears that "patient" should be changed to --a patient--.
In claim 1, line 41, it appears that "vascular access" should be changed to --subsequent vascular access--.
In claim 11, line 1, it appears that "data" should be changed to --data inputs--.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 2, 4-21, 23, 24, 26-29, and 31 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation "the console" in line 7. There is insufficient antecedent basis for this limitation in the claim.
Claim 2 recites the limitation "the plurality of data inputs" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 recites the limitation "the plurality of data inputs" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 12 recites the limitation "the one or more clinical rules" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Claim 13 recites the limitation "the one or more clinical rules" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Claim 20 recites an ultrasound probe operable coupled to the console. However, an ultrasound probe was already recited in claim 1.
Claim 21 recites the limitation "the tip-location" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 27 recites how the system is configured to train the ML model with historical data and feedback. However, these limitations were already recited in claim 1.
Claim 28 recites the limitation "the console" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 28 recites the limitation "the automatic determination" in line 27. There is insufficient antecedent basis for this limitation in the claim.
Claim 28 recites the limitation "the plurality of data inputs" in line 34. There is insufficient antecedent basis for this limitation in the claim.
Claim 28 recites the limitation "the tracking data" in line 35. There is insufficient antecedent basis for this limitation in the claim.
Claim 31 recites the limitation "the ultrasound probe" in line 11. There is insufficient antecedent basis for this limitation in the claim.
Claim 31 recites the limitation "the automatic determination" in line 30. There is insufficient antecedent basis for this limitation in the claim.
The remaining claims are rejected based on their dependency from the above claims.
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.
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, 2, 4-6, 10-13, 16-20, 26-29, and 31 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent App. Pub. No. 2022/0406460 to Golan et al. (“Golan”) in view of U.S. Patent App. Pub. No. 2019/0026438 to Ma et al. (“Ma”) and U.S. Patent No. 10,849,689 to Hu et al. (“Hu”):
Regarding claim 1, Golan discloses a system (system 100 in Figure 1) for automatically determining one or more medical devices for vascular access (the bottom of Figure 2, [0020], and [0107]-[0112] illustrate/disclose a method 200 (performed by system 100 per [0027]) including automatically selecting a medical device (e.g., type of catheter) for use in vascular access of a patient per [0063]), comprising:
a measuring device for measuring one or more patient condition parameters prior to or during the vascular access including at least one of: glucose levels, temperature, blood pressure, blood oxygenation, pH, lactate concentration, or a combination thereof ([0077] discloses signal collection devices such as heart rate monitor, blood pressure cuff, etc. (measuring device) as part of data receiving step S210 in Figure 2 which is ultimately used to recommend a particular vasculature device/treatment per S240 at [0063] such that the patient conditions parameters are measured prior to/during the vascular access);
an ultrasound probe (imaging modality in Figure 1 which can be an ultrasound imaging device per [0068], [0071] which necessarily includes a probe) operably coupled to the console (computing device/workstation of healthcare facility in Figure 1), wherein the ultrasound probe is deployed to image the vascular access by placing the ultrasound probe against a skin surface of patient resulting in generation of electrical signals ([0071] notes how the images can depict the vasculature which would be in the form of electrical signals received via placing the US probe on the patient's skin); and
a console to which the measuring device is operably connected (computing device/workstation of healthcare facility in Figure 1), the console including:
one or more processors (a computing system/workstation necessarily includes one or more processors);
memory including instructions configured to instantiate one or more processes that, when executed by the one-or-more processors ([0140] discloses memory/computer-readable medium storing instructions which necessarily instantiate processes) perform operations of:
receiving the one or more patient condition parameters from the measuring device ([0077] discloses how step S210 can include receiving signals (e.g., blood pressure) from a signal collection device (e.g., blood pressure cuff, etc.));
receiving the electrical signals from the ultrasound probe ([0071], [0072], [0076] disclose receiving images (which is necessarily in the form of electrical signals) from imaging modality which can be an ultrasound device having a probe as noted above) and generating an ultrasound image that is displayed on a display screen of the console ([0088] discloses presenting a visualization of the received images at a workstation at the healthcare facility (display screen of console per Figure 1));
…
performing a training operation of a machine learning model with historical data including the electrical signals generated by the ultrasound probe during the vascular access (step S240 in Figure 2 and [0106]-[0112] illustrates/discusses using an ML model to recommend a particular device (e.g., catheter) based on the received/analyzed data at steps S210, S220, S230 and then [0122] discloses training/retraining the model based on an outcome of a procedure based on an output from the method; accordingly, each time the model is retrained, the electrical signals generated by the probe during the vascular access become "historical data" used to train the model along with the corresponding procedure outcome/model output so as to improve predictions generated by the model because that is how ML model retraining works)…;
subsequent to the training operation, providing input to the machine learning model resulting in generation of a determination of one or more medical devices for a subsequent vascular access (after each training/retraining per [0122], then further input is received at S210, analyzed at S220, S230, and provided as input to the ML model to generate a recommended device/catheter per step S240 in Figure 2 and [0106]-[0112]);
…, and
wherein, following the determination by the machine learning model, the one or more medical devices are utilized in a vascular access procedure on a patient ([0063] and [0118] discuss scheduling/performing the vascular access surgical procedure in accordance with the recommended device).
While [0122] discloses training/retraining the model based on an outcome of a procedure based on an output from the method, Golan might be silent regarding receiving feedback on a first medical device used to perform the vascular access such that the training operation includes the feedback on the first medical device
Nevertheless, Ma teaches ([0011] and [0051]) that it was known in the healthcare informatics and machine learning art to mine patient data, provide the data to an ML model to generate a recommended medical procedure/test based on the mined data, and train the model based on feedback from physicians regarding the medical procedures/tests recommended by the ML model to advantageously increase the accuracy of the ML model thereby resulting in improved recommendations.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to receive feedback on a first medical device used to perform the vascular access (e.g., catheter per [0110]-[0112] of Golan) such that the training operation includes the feedback on the first medical device as taught by Ma to advantageously increase the accuracy of the ML model thereby resulting in improved recommendations. 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. Id.
Furthermore, Golan appears to be silent regarding the determination of the one or more medical devices for vascular access including a percent likelihood of success, a confidence level, or both.
Nevertheless, Hu teaches (6:21-49; 13:4-21) that it was known in the healthcare informatics art to utilize an ML model to receive one or more patient/surgical parameters and determine one or more surgical implants (medical devices) and associated confidence levels (e.g., likelihood of fitting a patient) to advantageously improve an accuracy of medical device estimation (1:45-46).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the determination of the one or more medical devices for vascular access of Golan to include a percent likelihood of success, a confidence level, or both as taught by Hu to advantageously improve an accuracy of medical device estimation. 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. Id.
Regarding claim 2, the Golan/Ma/Hu combination discloses the system of claim 1, further including wherein the plurality of data inputs is automatically pulled into the system ([0065] of Golan discloses how receipt of the various datasets can be triggered by the method 200 (automatically pulled into the system 100)).
Regarding claim 4, the Golan/Ma/Hu combination discloses the system of claim 2, further including wherein the plurality of data inputs include orders or patient data from an electronic medical-care-facility system having access to the patient data via electronic medical records for patients ([0075] of Golan discloses receiving data from an EMR/EHR).
Regarding claim 5, the Golan/Ma/Hu combination discloses the system of claim 4, further including wherein the orders are for specific medical devices, specific medications, or a combination thereof ([0068] of Golan discloses receiving images from various types of imaging modalities (specific medical devices) such as CT, MRI, ultrasound, etc.; each of the images is necessarily associated with an order for such imaging modality because orders are required for imaging studies).
Regarding claim 6, the Golan/Ma/Hu combination discloses the system of claim 1, further including wherein the display screen is integrated into the console, the display screen configured to display the one-or-more medical devices recommended for vascular access ([0115] discloses how a message indicating the determined device (e.g., catheter per [0110]-[0112]) can be delivered to the workstation to alert a surgeon (where such message would be presented via a display of the workstation)).
Regarding claim 10, the Golan/Ma/Hu combination discloses the system of claim 1, further including wherein the plurality of data inputs are manually input into the system by a clinician using the system ([0075] of Golan discloses receiving inputs from a specialist (clinician) at the application (manual input)).
Regarding claim 11, the Golan/Ma/Hu combination discloses the system of claim 1, further including wherein the plurality of data inputs include procedure type ([0063] and [0109] of Golan disclose a surgical procedures; also, [0073] discloses procedures the specialist is qualified/certified to perform), clinician experience ([0073] of Golan discloses specialist specialty/certifications/qualifications (experience)), one or more clinician preferences ([0073] of Golan discloses specialist preferences), medical-device inventory ([0073] of Golan discloses device inventory and [0135] discloses inventory information), one or more orders for specific medical devices ([0068] of Golan discloses receiving images from various types of imaging modalities (specific medical devices) such as CT, MRI, ultrasound, etc.; each of the images is necessarily associated with an order for such imaging modality because orders are required for imaging studies), patient data including patient condition or patient location ([0098] of Golan discloses clot type/composition/dimensions; [0136] discloses patient conditions), emergent indication, one or more orders for specific medications, one or more infusion-therapy parameters, one or more imaging parameters if the system includes an imaging modality ([0068], [0076] of Golan disclose receiving images from CT, MRI, etc. while [0092]-[0102] disclose determining parameters), dwell time, or a combination thereof.
Regarding claim 12, the Golan/Ma/Hu combination discloses the system of claim 11, further including wherein the one-or-more clinical rules include purchase length for a medical device ([0110] of Golan discloses how the system can select a particular catheter length based on the path length or the length of one or more vessels; accordingly, because step 240 of triggering the output is executed via computer algorithms and/or ML models, there are computer-implemented rules regarding the length of the catheter as it relates to the vessel length and/or path length), blood-vessel occupancy of the medical device ([0111] discloses how the catheter can have a diameter no larger than a narrowest part of the vessel to pass through; accordingly, there is a rule corresponding to such diameter because the triggering the output is executed via computer algorithms and/or ML models as noted above), dwell time for the medical device, or a combination thereof when the medical device is a catheter.
Regarding claim 13, the Golan/Ma/Hu combination discloses the system of claim 11, further including wherein the one-or-more clinical rules are factored into any automatic recommendations of the one-or-more medical devices for vascular access (the above-discussed rules are factored into the determination of medical devices/catheters for vascular access).
Regarding claim 16, the Golan/Ma/Hu combination discloses the system of claim 11, further including wherein the procedure type includes at least an intention for blood aspiration ([0108]-[0110] of Golan discloses how the procedure can involve aspiration and then how a medical device for such procedure can be determined; accordingly, the aspiration procedure is an input to determine the medical device type for such procedure).
Regarding claim 17, the Golan/Ma/Hu combination discloses the system of claim 11, further including wherein the prior difficulty in vascular access includes a determination of whether a blood vessel was visible, palpable, torturous, valvular, or a combination thereof ([0096]-[0099] of Golan disclose determination of vessel tortuosity which is then used as an input to determine the medical device per [0105] and Figure 2; the more tortuosity in the vessels there is, the greater the prior-difficulty in blood-vessel access there is).
Regarding claim 18, the Golan/Ma/Hu combination discloses the system of claim 11, further including wherein the patient condition includes blood pressure, hydration, nutrition, temperature, or a combination thereof ([0077] of Golan discloses blood pressure).
Regarding claim 19, the Golan/Ma/Hu combination discloses the system of claim 11, further including wherein the clinician experience includes clinician training for placing the one-or-more medical devices for vascular access or clinician proficiency for placing the one-or-more medical devices for vascular access ([0073] of Golan discloses specialist specialty/certifications/qualifications (experience) for performing procedures while [0031] discloses neurovascular specialists and vascular neurologists which thus have training/proficiency for placing medical devices for vascular access).
Regarding claim 20, the Golan/Ma/Hu combination discloses the system of claim 1, further including an ultrasound probe operably coupled to the console for ultrasound imaging (Figure 1 of Golan illustrates how an imaging modality is coupled to workstation (console) while [0071] discloses how the imaging modality can include an ultrasound scanner which are known to have a probe for operation).
Regarding claim 26, the Golan/Ma/Hu combination discloses the system of claim 1, further including wherein the one-or-more processes are further for automatically compiling and analyzing data (step 220 in Figure 2, [0079], and [0086] of Golan illustrate/disclose analyzing the dataset/signals) to identify data trends for reporting internally to a clinic including the system or externally to another care provider ([0087] of Golan discloses presenting (reporting) the analyzed data to one or more clinicians, medical device sales reps, etc.; furthermore, [0051] discloses how the outputs provided by the application (which are determined via analyzing the dataset/signals per 220/230 in Figure 2 and which are provided to a healthcare facility per [0046]) can include analytics related to tracking a workflow or activity in real-time which provides an indication of data trends).
Regarding claim 27, the Golan/Ma/Hu combination discloses the system of claim 1, further including wherein the system is configured to train the machine-learning model with the historical data (step S240 in Figure 2 and [0106]-[0112] illustrate using an ML model to recommend a particular device (e.g., catheter) based on the received/analyzed data at steps S210, S220, S230 and then [0122] discloses training/retraining the model based on an outcome of a procedure based on an output from the method; accordingly, each time the model is retrained, the electrical signals generated by the probe during the vascular access become "historical data" used to train the model along with the corresponding procedure outcome/model output so as to improve predictions generated by the model because that is how ML model retraining work) including a clinician-chosen medical device among the one-or-more medical devices recommended for vascular access, clinician feedback on whether the clinician-chosen medical device was successful for vascular access, a tracking record for the clinician-chosen medical device, or a combination thereof (Ma teaches ([0011] and [0051]) mining patient data, providing the data to an ML model to generate a recommended medical procedure/test based on the mined data, and training the model based on feedback from physicians regarding the medical procedures/tests recommended by the ML model to advantageously increase the accuracy of the ML model thereby resulting in improved recommendations; therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the historical data on which the ML model is trained to include clinician feedback on whether the clinician-chosen medical device was successful for vascular access as taught by Ma to advantageously increase the accuracy of the ML model thereby resulting in improved recommendations. 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. Id.).
Claim 28 is rejected in view of the Golan/Ma/Hu combination similar to as discussed in relation to claim 1 above. In relation to receiving feedback corresponding to the one-or-more medical devices as used in the vascular access procedure on the patient for the plurality of data inputs, wherein the feedback is incorporated into the historical data along with the tracking data and utilized in re-training the machine learning model, (step S240 in Figure 2 and [0106]-[0112] of Golan illustrates/discusses using an ML model to recommend a particular device (e.g., catheter) based on the received/analyzed data at steps S210, S220, S230 and then [0122] discloses training/retraining the model based on an outcome of a procedure based on an output from the method; accordingly, each time the model is retrained, the electrical signals generated by the probe during the vascular access become "historical data" used to train the model along with the corresponding procedure outcome/model output so as to improve predictions generated by the model because that is how ML model retraining work. Furthermore, Ma teaches ([0011] and [0051]) that it was known in the healthcare informatics and machine learning art to mine patient data, provide the data to an ML model to generate a recommended medical procedure/test based on the mined data, and train the model based on feedback from physicians regarding the medical procedures/tests recommended by the ML model to advantageously increase the accuracy of the ML model thereby resulting in improved recommendations. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to receive feedback corresponding to the one-or-more medical devices as used in the vascular access procedure on the patient for the plurality of data inputs, wherein the feedback is incorporated into the historical data along with the tracking data and utilized in re-training the machine learning model as taught by Ma to advantageously increase the accuracy of the ML model thereby resulting in improved recommendations. 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. Id.
Claim 29 is rejected in view of the Golan/Ma/Hu combination similar to as discussed in relation to claim 6 above.
Claim 31 is rejected in view of the Golan/Ma/Hu combination similar to as discussed in relation to claim 1 above. In relation to the generation of the determination of the medical device(s) for the subsequent vascular access using the trained ML model being in accordance with (i) the plurality of data inputs including tracking data including from ultrasound imaging, a tip-location sensor, fiber-optic shape sensing, or any combination thereof, and the patient condition parameters measured by the measuring device, and (ii) historical data of the plurality of data inputs, Golan discloses how the data inputs can include ultrasound image/tracking data ([0065], [0068], [0071]). Furthermore, step S240 in Figure 2 and [0106]-[0112] of Golan illustrates/discusses using an ML model to recommend a particular device (e.g., catheter) based on the received/analyzed data at steps S210, S220, S230 and then [0122] discloses training/retraining the model based on an outcome of a procedure based on an output from the method; accordingly, each time the model is retrained, the electrical signals generated by the probe during the vascular access become "historical data" used to train the model along with the corresponding procedure outcome/model output so as to improve predictions generated by the model because that is how ML model retraining work. Accordingly, as the ML is trained with the historical data, then generation of the determination of the medical device(s) for the subsequent vascular access using the trained ML model is "in accordance with" the historical data).
Claims 7 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent App. Pub. No. 2022/0406460 to Golan et al. (“Golan”) in view of U.S. Patent App. Pub. No. 2019/0026438 to Ma et al. (“Ma”) and U.S. Patent No. 10,849,689 to Hu et al. (“Hu”), and further in view of U.S. Patent App. Pub. No. 2020/0234812 to Willybiro et al. (“Willybiro”):
Regarding claim 7, the Golan/Ma/Hu combination discloses the system of claim 6, but appears to be silent regarding wherein the determination of the one-or-more medical devices for vascular access is further in accordance with 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.
Nevertheless, Willybiro teaches that it was known in the healthcare informatics art for a therapy system 200 to receive data regarding type of catheters previously used, length that catheter was present in patient’s body, etc. (operating parameters) ([0028], [0053]) including data regarding a clinician’s training/qualifications to use certain types of catheters via a clinician training module ([0033], [0054]) and determine and display via a user device (e.g., tablet) a recommendation of a medical device (e.g., catheter) to be used for a medical procedure ([0027], [0034], [0055]) based on the parameters/data. Figure 2 illustrates how the user device/tablet includes a display of a decision tree that incorporates clinician training status per [0033] (where such display of the decision tree and training amounts to “clinician messaging” because it conveys a message to a clinician regarding the training, etc.). This arrangement advantageously recommends medical devices (e.g., catheters) that correspond to a particular level of training of the clinician thereby avoiding adverse patient outcomes ([0033]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the automatic determination of the one-or-more medical devices for vascular access in the Golan/Ma/Hu combination to further be in accordance with various operating parameters including 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. 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. Id.
Regarding claim 14, the Golan/Ma/Hu combination discloses the system of claim 11, but appears to be silent regarding wherein the one-or-more infusion-therapy parameters include fluid replacement, potassium replacement, 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.
Nevertheless, Willybiro teaches that it was known in the healthcare informatics art that catheters are used for a wide variety of infusion therapies ([0002]) and to access data including medicament infusions (fluid replacement, medications) and determine and display via a user device (e.g., tablet) a recommendation of a medical device (e.g., catheter) to be used for a medical procedure ([0027], [0034], [0055]) based on the data to advantageously recommended medical devices that are more closely tailored to a type of infusion being administered and thereby avoid adverse patient outcomes.
Therefore, it would have been obvious to one of ordinary skill in the art before 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 the Golan/Ma/Hu combination 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. 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. Id.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent App. Pub. No. 2022/0406460 to Golan et al. (“Golan”) in view of U.S. Patent App. Pub. No. 2019/0026438 to Ma et al. (“Ma”), U.S. Patent No. 10,849,689 to Hu et al. (“Hu”), and U.S. Patent App. Pub. No. 2020/0234812 to Willybiro et al. (“Willybiro”), and further in view of U.S. Patent App. Pub. No. 2018/0204155 to Bradbury et al. (“Bradbury”):
Regarding claim 8, the Golan/Ma/Hu/Willybiro combination discloses the system of claim 7, but appears to be silent regarding wherein only clinicians having the confirmation of the clinician training are allowed to use the system for the determination of the one-or-more medical devices for vascular access.
Nevertheless, Bradbury teaches ([0028]) that it was known in the healthcare informatics art to prevent unauthorized access to a health risk computing system by a user unless the user has appropriate training and qualifications which would advantageously prevent use of the system by unqualified users and maintain validity and reliability of the system ([0026]).
Therefore, it would have been obvious to one of 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 the Golan/Ma/Hu/Willybiro combination as taught by Bradbury to advantageously prevent use of the system by unqualified users and maintain validity and reliability of the system. 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. Id.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent App. Pub. No. 2022/0406460 to Golan et al. (“Golan”) in view of U.S. Patent App. Pub. No. 2019/0026438 to Ma et al. (“Ma”) and U.S. Patent No. 10,849,689 to Hu et al. (“Hu”), and further in view of U.S. Patent App. Pub. No. 2006/0149214 to Breitner et al. (“Breitner”):
Regarding claim 15, the Golan/Ma/Hu combination discloses the system of claim 11, further including receiving images from CT, MRI, etc. ([0068], [0076], and Figure 1 of Golan) and determining parameters ([0092]-[0102]) for input into the ML model for determining the medical devices ([0105], [0110]).
However, the Golan/Ma/Hu combination appears to be silent regarding wherein the one-or-more imaging parameters include at least an intention for power injection while imaging.
Nevertheless, Breitner teaches that it was known in the healthcare informatics art to utilize power injectors to inject contrast media into patients during vascular imaging (CT, MRI) ([0092]) which is known to improve the clarity and visibility of structures in obtained images and to use particular types of catheters designed for power injection that advantageously support the high pressure and high flow rate environments of contrast media power injection ([0005]-[0006]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize power injectors to inject contrast media into the patient during vascular imaging in the system of the Golan/Ma/Hu combination as taught by Breitner to improve the clarity and visibility of structures in the obtained images and for the one-or-more imaging parameters of the Golan/Ma/Hu combination to include at least an intention for power injection while imaging as taught by Breitner to advantageously facilitate selection of catheters specifically designed to withstand the high pressure and high flow rate environments of contrast media power injection thereby improving the likelihood of a successful injection. 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. Id.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent App. Pub. No. 2022/0406460 to Golan et al. (“Golan”) in view of U.S. Patent App. Pub. No. 2019/0026438 to Ma et al. (“Ma”) and U.S. Patent No. 10,849,689 to Hu et al. (“Hu”), and further in view of U.S. Patent App. Pub. No. 2009/0234328 to Cox et al. (“Cox”):
Regarding claim 21, the Golan/Ma/Hu combination discloses the system of claim 20, where the determined medical device can be a catheter ([0110] of Golan), but appears to be silent regarding the system further including a tip-location sensor configured to rest upon a chest of a patient, the tip-location sensor configured to locate a tip of a medical device within a vasculature of the patient.
Nevertheless, Cox teaches ([0075]) that it was known in the healthcare informatics art to utilize a tip location sensor configured to rest on the chest of a patient to advantageously assist in the navigation of a catheter tip to a desired location within the patient’s vasculature.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the system of the Golan/Ma/Hu combination to include a tip-location sensor configured to rest upon a chest of a patient, the tip-location sensor configured to locate a tip of a medical device within a vasculature of the patient, as taught by Cox to advantageously assist in the navigation of a catheter tip to a desired location within the patient’s vasculature. 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. Id.
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent App. Pub. No. 2022/0406460 to Golan et al. (“Golan”) in view of U.S. Patent App. Pub. No. 2019/0026438 to Ma et al. (“Ma”) and U.S. Patent No. 10,849,689 to Hu et al. (“Hu”), and further in view of Int'l Pub. No. WO 2022/254436 to Shachar et al. ("Shachar"):
Regarding claim 23, the Golan/Ma/Hu combination discloses the system of claim 1, further including wherein the console is a …computing device with a display screen integrated therein (computing system/workstation of Figure 1 of Golan which includes a display screen integrated therein at least because [0088] of Golan discloses presenting a visualization of the received images at the workstation of the healthcare facility);
However, the Golan/Ma/Hu combination might be silent regarding the computing system/workstation specifically being portable.
Nevertheless, Shachar teaches that it was known in the healthcare informatics art for a system used to manage insertion of a medical instrument (2:18-31) such as a catheter (13:31-14:1) into a patient using machine learning (5:14-6:8) and ultrasound imaging (18:25-29) to include a portable workstation/controller including a display to monitor obtained images (Figure 1B; 16:29-17:24) to advantageously allow the controller/workstation to be moved to a convenient location thereby facilitating its use and improving its utility.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the computing system/workstation of the Golan/Ma/Hu combination to specifically be portable as taught by Shacher to advantageously allow the computing system/workstation to be moved to a convenient location thereby facilitating its use and improving its utility. 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. Id.
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent App. Pub. No. 2022/0406460 to Golan et al. (“Golan”) in view of U.S. Patent App. Pub. No. 2019/0026438 to Ma et al. (“Ma”) and U.S. Patent No. 10,849,689 to Hu et al. (“Hu”), and further in view of U.S. Patent No. 11,974,813 to Donhowe et al. (“Donhowe”):
Regarding claim 24, the Golan/Ma/Hu combination discloses the system of claim 1, further including wherein the system is further for automatic determination of additional procedure-related items for the vascular access with the one-or-more medical devices ([0110] of Golan discloses coils, braids, revascularization device, etc.), …
However, the Golan/Ma/Hu combination appears to be silent regarding the additional procedure-related items including gowns, drapes, gloves based upon size, or a combination thereof.
Nevertheless, Donhowe teaches (5:8-11; 8:10-19) that it was known in the healthcare informatics art for a surgical procedure analysis system 104 to analyze surgical data to determine recommendations for improving a surgical procedure such as suggestions for particular drape quantities to be included in a surgical procedure setup plan to advantageously avoid delays caused by running out of drapes during the surgical procedure.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the automatically determined additional procedure-related items of the Golan/Ma/Hu combination to include particular drape quantities as taught by Donhowe to advantageously avoid delays caused by running out of drapes during the surgical procedure. 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. Id.
Allowable Subject Matter
Claim 9 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 9, the Golan/Ma/Hu/Willybiro/Bradbury combination discloses the system of claim 8, but fails to further specifically disclose or suggest the display screen to be further configured to display the clinician messaging with recommendations for escalation including one or more alternative clinicians allowed to use the system for the determination of the one or more medical devices for vascular access in view of the one or more alternative clinicians having the confirmation of the clinician training.
Conclusion
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/JONATHON A. SZUMNY/Primary Examiner, Art Unit 3686
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