DETAILED ACTION
Acknowledgements
This office action is in response to the claims filed January 09, 2026
Claims 1-3 and 6-9 and 12-20 are pending.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendments
Claims 1-3 and 6-9 and 12-20 remain pending. Drawing objection has been overcome.
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 1-3 and 6-9 and 12-20 are rejected to under 35 U.S.C 101 as not being directed to eligible subject matter based on the grounds set out in detail below:
Independent Claims 1, 16, and 20:
Eligibility Step 1 (does the subject matter fall within a statutory category?):
Independent Claim 1 falls within the statutory category of process
Independent Claim 16 falls within the statutory category of machine
Independent Claim 20 falls within the statutory category of article of manufacture
Eligibility Step 2A-1 (does the claim recite an abstract idea, law of nature, or natural phenomenon?): Independent claims 1, 16, and 20 (claim 1 being representative below) claimed invention is directed to an abstract idea without significantly more.
The claim elements which set forth the abstract idea in claims 1, 16, and 20 (claim 1 being representative) are:
A method for vascular access device placement, comprising:
stores identification data associated with a type of the vascular access device,
determining, a location of the vascular access device in the facility
and using the known location
recording, vascular access attempt data associated with an attempted placement of the vascular access device
wherein the vascular access attempt data is recorded in response
receiving, clinician identification data associated with at least one clinician including a first clinician and patient identification data associated with at least one patient including a first patient,
receive, the clinician identification data and the patient identification data,
communicate the clinician identification data and the patient identification data together with the type of the vascular access device and the location of the vascular access device
wherein the vascular access attempt data comprises at least one of: an update to patient data associated with the first patient; an update to clinician data associated with the first clinician; a first access point at which the attempted placement was performed; an indication of whether the attempted placement was successful; and a time from when placement was ordered to the attempted placement;
generating, at least one first probability of successful placement by the first clinician at an access point of the first patient based on the patient data associated with the first patient, the clinician data associated with the first clinician, and the vascular access attempt data,
wherein generating the at least one first probability comprises generating the at least one first probability , based on historical clinician data associated with a plurality of clinicians and historical patient data associated with a plurality of patients,
and wherein generating the at least one first probability includes automatically using most recent clinician data and most recent patient data, as stored so that a probability of successful placement by the first clinician is updated in real time based on the most recent clinician data and patient data available;
before generating the at least one first probability, based on the historical clinician data and the historical patient data, the historical clinician data including historical placement data for a plurality of clinicians for a plurality of attempted placements recorded
generating, instructions for placement at the access point associated with the at least one first probability;
causing, to present at least a portion of the instructions for placement at the access point associated with the at least one first probability;
before presenting the instructions for placement
determining, that the first probability does not satisfy a threshold;
and generating, the instruction message indicating an instruction for at least one intervention for placement based on the at least one first probability failing to satisfy the threshold,
wherein the at least one intervention comprises instructions to use at least one of a second clinician for placement;
generating, , each of: at least one second probability of successful placement by the first clinician at the at least one access point of the first patient based on the patient data associated with the first patient,
the clinician data associated with the first clinician, and guidance data associated of the at least one intervention;
at least one third probability of successful placement by a second clinician of the at least one clinician at the at least one access point of the first patient based on the patient data associated with the first patient and the clinician data associated with the second clinician;
and at least one fourth probability of successful placement by the second clinician at the at least one access point of the first patient based on the patient data associated with the first patient, the clinician data associated with the second clinician, and the guidance data associated with the at least one intervention;
determining, the at least one intervention to instruct based on the second probability, the third probability, and the fourth probability;
receiving, input data based on the attempted placement;
adjusting, based on the input data, the threshold, and storing, the input data as updated clinician data and updated patient data,
automatically uses the updated clinician data and the updated patient data as the most recent clinician data and the most recent patient data for generating the at least one first probability and for generating instruction messages for future placements
This abstract idea is merely collecting and manipulating data to aid in placing a medical device by identifying devices and generating probabilities of successful vascular access placement for a patient and communicating placement instructions to a clinician. This is no more than managing the personal behavior or interactions a medical professional should take to give the best care when determining the correct vascular access placement for a patient prior to performing and this can be done mentally or with pen and paper aid for example which is managing personal behavior or interactions between people by following rules and instructions within “certain methods of organizing human activity” See MPEP § 2106.04(a)(2).
Eligibility Step 2A-2 (does the claim recite additional elements that integrate the judicial exception into a practical application?): For Independent claims 1, 16, and 20 this judicial exception is not integrated into a practical application.
Independent claims recite the additional claim elements below:
at least one processor of a vascular access device placement modeling system
a reader device of a plurality of reader devices comprises a transmitter configured to transmit an interrogation signal and a receiver configured to receive a response signal with signals for predetermined locations within a facility
a vascular access device identification device included with a protective covering of a vascular access device, the protective covering prevents access to the vascular access device identification device by the vascular access device placement modeling system until the protective covering is opened, wherein the vascular access device identification device is configured to produce the signal in response to opening of the protective covering of the vascular access device;
at least one clinician identification device comprising a first clinician identification device comprises a radio frequency identification (RFID) tag
an RFID communication connection
a device associated with the vascular access device
at least one patient identification device comprising a first patient identification device comprises a radio frequency identification (RFID) tag
at least one user device
at least one database
at least one guidance system
A computer program product for vascular access device placement comprising at least one non-transitory computer-readable medium including one or more instructions execute by a processor
A trained neural network
Examiner takes the applicable considerations stated in MPEP 2106.04 (d) and analyzes them below in light of the instant applications disclosure and claim elements as a whole.
The noted above additional claim element, (1) at least one processor of a vascular access device placement modeling system and (2) A computer program product for vascular access device placement comprising at least one non-transitory computer-readable medium including one or more instructions execute by a processor, is executing the abstract idea and recited in the manner of merely invoking the element as a tool using terms such as “apply-it” or an equivalent (e.g., “generating with at least one processor”)
The additional elements, (1) at least one clinician identification device comprising a first clinician identification device comprises a radio frequency identification (RFID) tag, (2) a device associated with the vascular access device, (3) a vascular access device identification device included with a protective covering of a vascular access device, the protective covering prevents access to the vascular access device identification device by the vascular access device placement modeling system until the protective covering is opened, wherein the vascular access device identification device is configured to produce the signal in response to opening of the protective covering of the vascular access device; and (4) at least one patient identification device comprising a first patient identification device comprises a radio frequency identification (RFID) tag, are generally linking the abstract idea to the environment of vascular medical devices
The additional elements, (1) a reader device of a plurality of reader devices comprises a transmitter configured to transmit an interrogation signal and a receiver configured to receive a response signal with signals for predetermined locations within a facility, (2) an RFID communication connection, (3) at least one database, (4) at least one guidance system, and (5) at least one user device are recited in the manner of merely invoking the element as a tool using terms such as “apply-it” or an equivalent for gathering data
The additional element, a trained neural network, is merely apply-it to analyze data
Accordingly, independent claims 1, 16, and 20 as a whole do not integrate the recited abstract idea into a practical application (MPEP 2106.05(f)).
Eligibility Step 2B (Does the claim amount to significantly more?): The independent claims 1, 16, and 20 do not include additional elements that are sufficient to amount to significantly more than the judicial exception because as analyzed above in step 2A prong 2, these additional elements, are merely generally linking or “apply-it”. The same analysis also applies here. Therefore, the claims do not amount to significantly more and the claims are patent ineligible.
Dependent Claims 2, 3, 6-9, 12-15, and 17-19:
Eligibility Step 1 (does the subject matter fall within a statutory category?):
The dependent claims 2, 3, 6-9, 12-15 fall within the statutory category of process
The dependent claims 17-19 fall within the statutory category of machine.
Eligibility Step 2A-1 (does the claim recite an abstract idea, law of nature, or natural phenomenon?): Dependent claims 2, 3, 6-9, 12-15, and 17-19 claimed invention is directed to an abstract idea without significantly more. The claims further limit the abstract idea by (1) further limiting the types of patient and clinician data, (2) further limiting the process of coming to the probability, and (3) further limiting generation of the vascular placement guidance. The claims further depend from independent claims 1 and 16 thus inheriting the same abstract idea which is managing personal behavior or interactions between people within “certain methods of organizing human activity” See MPEP § 2106.04(a)(2).
Eligibility Step 2A-2 (does the claim recite additional elements that integrate the judicial exception into a practical application?): For claims 2, 3, 6-9, 12-15, and 17-19 this judicial exception is not integrated into a practical application.
The claims recite the additional elements below not already recited in the independent claims:
at least one graphical user interface (GUI)
at least one server
Examiner takes the applicable considerations stated in MPEP 2106.04 (d) and analyzes them below in light of the instant applications disclosure and claim elements as a whole.
The additional element, at least one graphical user interface (GUI), is generally linking the abstract idea to computer implementation
The additional element, at least one server, is merely used as a tool to implement the abstract idea and is “apply-it”
Therefore, the claims do not overcome eligibility step 2A-2 and do not integrate into a practical application.
Eligibility Step 2B (Does the claim amount to significantly more?): The additional elements considered in the dependent claims both alone and in an ordered combination do not amount to more than the judicial exception as they are generally linking or merely “apply-it”. The claims are not patent eligible.
Subject Matter Free of Prior Art
Claims 1-3 and 6-9 and 12-20 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. § 101 and any objections, set forth in this Office action.
The cited prior art of record fails to expressly teach or suggest, either alone or in combination, the features found within the independent claims (Claim 1 recited here as representative). In particular, the cited prior art of record fails to expressly teach or suggest the combination of limitations found in the independent claims and were not found as positively recited in the prior art. For additional reasons of allowance, see pages 3-4 of applicant’s remarks filed June 26, 2025.
The most remarkable prior art of record is as follows:
• Morris et. al: WO2020160550A1
o A vascular access guidance system is provided for guiding a practitioner
in association with various types of medical procedures, including needle or
probe insertion procedures involving different vessels or tissues of a human or animal patient, for example. The guidance system may include a guidance device including a clamping mechanism portion and an imaging apparatus, among other elements. The clamping mechanism can be structured to secure one or more kinds of handheld mobile devices which provide a screen display for displaying images during the medical procedure. The guidance system is designed to for manual manipulation in a single hand of a user. In certain embodiments, a computer-based or software-based a vascular assessment tool can be provided which may be downloaded or installed for use on the mobile device. The vascular access guidance system and/or the vascular assessment tool may be applied in the context of certain training devices and educational tools described herein.
• Black: US11065080B2
o Medical procedure related objects ( e.g. , instruments , sup plies ) tagged with transponders ( e.g. , RFID transponders , dumb transponders ) are accounted for in a medical or clinical environment via an accounting system using a number of antennas and interrogators / readers . A first set of antennas and RFID interrogator ( s ) interrogate portions of the environment for RFID tagged objects , for example proximate a start and an end of a procedure . A cannula of a trocar may include one or more trocar antennas positioned and oriented to integrate tapped objects that pass through a lumen of the cannula . Shielded packaging and / or shielded receptacles shield tagged objects , preventing interrogation except for those objects in unshielded portions of the environment . A data store may maintain information including a current status or count of each instrument or supply , for instance as checked in or checked out . A handheld antenna and / or second set of antennas interrogates a body of a patient for retained instruments or supplies tagged with dumb transponders.
Qi et. al: US11445996B2
o A method of navigating and positioning an endovascular device in a vasculature is disclosed . Initially , a system including an endovascular device and at least one transducer is inserted into the lumen of a patient . An acoustic signal is then transmitted within the lumen . A reflected signal is pre - processed to extract one or more acoustic features . The one or more acoustic features are processed using a com puter readable set of rules to produce an output related to guidance of the instrument within a blood vessel or a position of the instrument within the blood vessel.
Meng et. al: US20160203288A1
o Systems and methods for identifying historical vasculature cases are disclosed. A method may use a case database and a processor. One Such method comprises the step of retrieving (an image of the vasculature, demographic factors, morphological factors, and hemodynamic factors of the individual. The image is segmented and a geometry is calculated using the processor. Fluid flow may be simulated based on the hemodynamic factors and the calculated geometry. Calculations and factors are stored in the case database and relevant cases are identified based on the calculated geometry of the vasculature, the simulated fluid flow, and the demographic factors in comparison to the cases in the case database.
THUERING. et. al: US20230157552A1
o Systems and methods for identifying historical vasculature cases are disclosed. A method may use a case database and a processor. One Such method comprises the step of retrieving (an image of the vasculature, demographic factors, morphological factors, and hemodynamic factors of the individual. The image is segmented and a geometry is calculated using the processor. Fluid flow may be simulated based on the hemodynamic factors and the calculated geometry. Calculations and factors are stored in the case database and relevant cases are identified based on the calculated geometry of the vasculature, the simulated fluid flow, and the demographic factors in comparison to the cases in the case database.
Response to Arguments Regarding 35 U.S.C § 101 Rejection
The applicant argues on pages 1-3 of the submitted remarks that the amended claims under 35 U.S.C § 101 are eligible for the following arguments: The claimed invention, as amended, is not directed merely to an abstract "method of organizing human activity", "prediction" or "recommendation," but to a specific, technologically implemented vascular access device placement modeling system that includes: (i) RFID tags on vascular access devices, clinicians, and patients; (ii) a plurality of RFID reader devices at known locations in a facility; and (iii) a neural-network-based modeling system that automatically uses most recent clinician and patient data read from these RFID tags and stored its own database to update probabilities in real time. First, the claim recites that the vascular access device identification device is an RFID tag included with a protective covering, and that "the signal is inaccessible to the at least one processor until the protective covering is opened" and the tag "is configured to produce the signal in response to opening of the protective covering." In combination with a plurality of reader devices disposed at different known predetermined locations and RFID tags worn by the clinician and patient, the system automatically detects: (1) when a sterile device is actually opened, (2) where in the facility this occurs, and (3) which clinician and which patient are involved. The claimed invention further requires that vascular access attempt data is recorded in response to the signal being received and communicated to the processor. This is not generic data gathering; it is a concrete RFID-based sensing and tracking infrastructure that automatically and reliably captures real-world vascular access attempts tied to specific devices, clinicians, patients, times, and locations.
Second, the claim requires that the neural network model "automatically [uses] most recent clinician data and most recent patient data, as stored by the vascular access device placement modeling system in at least one database ... for each placement ... so that a probability of successful placement ... is updated in real time based on the most recent clinician data and patient data available." Thus, the modeling system continually ingests the automatically captured attempt data from the RFID infrastructure, stores it, and dynamically updates the probabilities for subsequent placements in real time. This is a particular manner of operating the system through an online, continuously updating predictive engine driven by automatically sensed attempt events rather than a generic, static application of a model to arbitrary data.
Under the 2019 Revised Patent Subject Matter Eligibility Guidance, these additional elements integrate any alleged abstract idea into a practical application (Step 2A, Prong Two). The claims are rooted in a specific technical environment that includes a tagged sterile device, tagged clinician and patient, and a plurality of RFID readers, and the claims use that environment to automatically generate, store, and exploit accurate, real-time attempt data to control how the neural network operates. Even if a judicial exception were found at Step 2A, the combination of: (1) RFID-only, package-gated access to device identity; (2) location-resolving plurality of readers; (3) clinician and patient RFID tags; and (4) real-time, database-driven updating of probabilities by the neural network, is not a conventional or generic use of computers or RFID, and supplies an inventive concept under Step 2B. Accordingly, when viewed as a whole, the claimed invention, as amended, is directed to a specific, real-time adaptive RFID-based vascular access system, not to an abstract idea. Withdrawal of the rejection under 35 U.S.C. § 101 is respectfully requested.
Respectfully examiner disagrees and concludes that the applicant’s arguments are not persuasive.
The MPEP states in 2106.05(b), “It is noted that while the application of a judicial exception by or with a particular machine is an important clue, it is not a stand-alone test for eligibility. The particularity or generality of the elements of the machine or apparatus, i.e., the degree to which the machine in the claim can be specifically identified (not any and all machines). One example of applying a judicial exception with a particular machine is Mackay Radio & Tel. Co. v. Radio Corp. of America, 306 U.S. 86, 40 USPQ 199 (1939). In this case, a mathematical formula was employed to use standing wave phenomena in an antenna system. The claim recited the particular type of antenna and included details as to the shape of the antenna and the conductors, particularly the length and angle at which they were arranged. 306 U.S. at 95-96; 40 USPQ at 203. Another example is Eibel Process, in which gravity (a law of nature or natural phenomenon) was applied by a Fourdrinier machine (which was understood in the art to have a specific structure comprising a headbox, a paper-making wire, and a series of rolls) arranged in a particular way to optimize the speed of the machine while maintaining quality of the formed paper web. Eibel Process Co. v. Minn. & Ont. Paper Co., 261 U.S. 45, 64-65 (1923).
It is important to note that a general purpose computer that applies a judicial exception, such as an abstract idea, by use of conventional computer functions does not qualify as a particular machine. Ultramercial, Inc. v. Hulu, LLC, 772 F.3d 709, 716-17, 112 USPQ2d 1750, 1755-56 (Fed. Cir. 2014). See also TLI Communications LLC v. AV Automotive LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (mere recitation of concrete or tangible components is not an inventive concept); Eon Corp. IP Holdings LLC v. AT&T Mobility LLC, 785 F.3d 616, 623, 114 USPQ2d 1711, 1715 (Fed. Cir. 2015) (noting that Alappat’s rationale that an otherwise ineligible algorithm or software could be made patent-eligible by merely adding a generic computer to the claim was superseded by the Supreme Court’s Bilski and Alice Corp. decisions). If applicant amends a claim to add a generic computer or generic computer components and asserts that the claim recites significantly more because the generic computer is 'specially programmed' (as in Alappat, now considered superseded) or is a 'particular machine' (as in Bilski), the examiner should look at whether the added elements integrate the exception into a practical application or provide significantly more than the judicial exception. Merely adding a generic computer, generic computer components, or a programmed computer to perform generic computer functions does not automatically overcome an eligibility rejection. Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 573 U.S. 208, 223-24, 110 USPQ2d 1976, 1983-84 (2014). See In re Alappat, 33 F.3d 1526, 1545, 31 USPQ2d 1545, 1558 (Fed. Cir. 1994); In re Bilski, 545 F.3d 943, 88 USPQ2d 1385 (Fed. Cir. 2008).
Integral use of a machine to achieve performance of a method may integrate the recited judicial exception into a practical application or provide significantly more, in contrast to where the machine is merely an object on which the method operates, which does not integrate the exception into a practical application or provide significantly more. See CyberSource v. Retail Decisions, 654 F.3d 1366, 1370, 99 USPQ2d 1690, 1694 (Fed. Cir. 2011) ("We are not persuaded by the appellant's argument that the claimed method is tied to a particular machine because it ‘would not be necessary or possible without the Internet.’ . . . Regardless of whether "the Internet" can be viewed as a machine, it is clear that the Internet cannot perform the fraud detection steps of the claimed method"). For example, as described in MPEP § 2106.05(f), additional elements that invoke computers or other machinery merely as a tool to perform an existing process will generally not amount to significantly more than a judicial exception. See, e.g., Versata Development Group v. SAP America, 793 F.3d 1306, 1335, 115 USPQ2d 1681, 1702 (Fed. Cir. 2015) (explaining that in order for a machine to add significantly more, it must "play a significant part in permitting the claimed method to be performed, rather than function solely as an obvious mechanism for permitting a solution to be achieved more quickly").
and states in 2106.05(a), “It is important to note, the judicial exception alone cannot provide the improvement. The improvement can be provided by one or more additional elements.”
In response to applicants arguments examiner notes that to the point of a technical improvement in which applicant argues that the amendments as positively claimed provide a concrete RFID-based sensing and tracking infrastructure that automatically and reliably captures real-world vascular access attempts tied to specific devices, clinicians, patients, times, and locations, the recited RFID technology and various computer devices are apply – it level used as a tool to gather data. The RFID additional element as well as the other additional elements recited by examiner are not improved within the claim construction themselves and do not perform the steps as recited in the claim of generating instruction information based on abstract data gathered and analyzed for guidance of the vascular access placement, rather these steps are confined to a general processor and mere automation of an abstract idea via a general processor does not in this case integrate the abstract idea into a practical application.
Secondly, the argument made that the practical application comes from the modeling system continually ingesting the automatically captured attempt data from the RFID infrastructure, storing it, and dynamically updating the probabilities for subsequent placements in real time therefore it is a particular manner of operating the system through an online, continuously updating predictive engine driven by automatically sensed attempt events rather than a generic, static application of a model to arbitrary data, examiner respectfully disagrees this makes it integrated into a practical application. While the real time aspect is considered it does not make it dispositive of being directed to an abstract idea as data can be viewed in real time by a human and decisions made from this data and abstract. The abstract idea cannot bring about the practical application. The trained neural network modeling system is broadly applied to analyze the probability data and there is no technical problem identified where there is an issue between static and dynamic neural network modeling and no reflection or recited improvement to the neural network modelling system itself within the confines of the general purpose computer environment the claims are constructed under. The remainder of the statistical data gathering, storing, and analyzing steps are abstract and the abstract idea cannot bring forth the practical application. For these aforementioned reasons the claims also do not bring about significantly more.
Examiner maintains the 35 U.S.C § 101 rejection even in light of the amendments to the claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ashley Elizabeth Evans whose telephone number is (571) 270-0110. The examiner can normally be reached Monday – Friday 8:00 AM – 5:00 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mamon Obeid can be reached on (571) 270-1813. The fax phone number for the organization where this application or proceeding is assigned 571-273-8300.
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/ASHLEY ELIZABETH EVANS/Examiner, Art Unit 3687
/MAMON OBEID/Supervisory Patent Examiner, Art Unit 3687
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