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 .
Notice to Applicant
This communication is in response to the amendment filed 05/18/2026. Claims 1-13, 15-20 have been amended. Claims 1-20 have been presented for examination.
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 1-20 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. Based upon consideration of all of the relevant factors with respect to the claims as a whole, the claims are directed to non-statutory subject matter which do not include additional elements that are sufficient to amount to significantly more than the judicial exception because of the following analysis:
Claim 1 is drawn to a system which is within the four statutory categories (i.e., machine). Claim 15 is drawn to a method which is within the four statutory categories (i.e., method).
Independent claim 1 (which is representative of independent claim 15) recites… at least one responder profile associated with a corresponding responder, the responder profiles including information that identifies one or more characteristics of the one or more responders, the one or more characteristics including a qualification of the one or more responders to assist the patient with the medical device, … match a responder of the one or more responders based on a service request received to render assistance to the patient with a medical device item, of the plurality of medical device items, having the size or the type corresponding to the service request, wherein to match the responder…determine availability of the one or more responders based on at least one of the one or more characteristics including a location of the one or more responders; and receive a reply from at least one matching responder from the available one or more responders…, in response to a notification communicated to the one or more responders; verify…whether a medical device item in the at least one matching responder's inventory is of the size or the type corresponding to the service request; and schedule an appointment between the at least one matching responder and the patient to provide the medical device item verified in the at least one matching responder's inventory and to assist in fitting the medical device on the patient by the at least one matching responder….
Under its broadest reasonable interpretation, the limitations noted above, as drafted, covers certain methods of organizing human activity (i.e., managing personal behavior or relationships or interactions between people…following rules or instructions), but for the recitation of generic computer components. That is, other than reciting “one or more processors” (claim 1), “a central platform” (claim 15), the claim encompasses rules or instructions to help a provider match with a patient and fit a medical device to the patient. If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or relationships or interactions between people, but for the recitation of generic computer components, then it falls within the “Certain Methods of Organizing Human Activity” grouping of abstract ideas. Accordingly, the claims recite an abstract idea.
Claim 1 recites additional elements (i.e., A medical product resource management system, comprising: a medical device configured to selectively provide treatment to a patient, wherein the medical device has a size or a type corresponding to the patient; one or more responder devices associated with one or more responders qualified to assist the patient in using the medical device; an inventory system including one or more databases configured to identify a plurality of medical device items, including a size or a type of each of the plurality of medical device items, available to at least one of the one or more responders; and a central platform including a database of responder profiles; wherein the central platform comprises one or more processors; a responder device of the at least one matching responder; wherein the medical device is configured to: enable, based on a fitment of the medical device on the patient, monitoring of the patient for a medical event; and upon detecting that the medical event is being experienced by the patient, control discharge circuitry of the medical device to deliver a therapy to the patient for the treatment of the medical event, wherein an effectiveness of the delivered therapy is related to an accuracy of the fitment of the medical device on the patient). Claim 15 recites additional elements (i.e., a medical device provisioning system; a central platform; a responder device of the at least one matching responder; wherein the medical device is configured to: enable, based on a fitment of the medical device on the patient, monitoring of the patient for a medical event; and upon detecting that the medical event is being experienced by the patient, controlling discharge circuitry of the medical device to deliver a therapy to the patient for a treatment of the medical event, wherein an effectiveness of the delivered therapy is related to an accuracy of the fitment of the medical device on the patient). Looking to the specifications, an inventory system including one or more databases; a central platform including a database, one or more processors is described at a high level of generality (¶ 0084; ¶ 0097), such that it amounts to no more than mere instructions to apply the exception using generic computer components. Also, “a medical device configured to selectively provide treatment to a patient, wherein the medical device has a size or a type corresponding to the patient” and “wherein the medical device is configured to: enable, based on a fitment of the medical device on the patient, monitoring of the patient for a medical event; and upon detecting that the medical event is being experienced by the patient, control discharge circuitry of the medical device to deliver a therapy to the patient for the treatment of the medical event, wherein an effectiveness of the delivered therapy is related to an accuracy of the fitment of the medical device on the patient” only invokes the medical device merely as a tool in its ordinary capacity to perform an existing process (i.e., monitoring, administering therapy), which amounts to no more than a recitation of the words "apply it" (or an equivalent) and only generally links the claimed invention to a particular technological environment or field of use, which does not impose meaningful limits on the scope of the claim. Furthermore, adding a step of “enable, based on a fitment of the medical device on the patient, monitoring of the patient for a medical event; and upon detecting that the medical event is being experienced by the patient, control discharge circuitry of the medical device to deliver a therapy to the patient for the treatment of the medical event, wherein an effectiveness of the delivered therapy is related to an accuracy of the fitment of the medical device on the patient” to a process that only recites helping a provider match with a patient and fit a medical device to the patient does not add a meaningful limitation to the process of matching a patient with a provider and scheduling between the respective parties, and as such, amounts to insignificant extrasolution activity. Also, “one or more responder devices associated with one or more responders qualified to assist the patient in using the medical device” only invokes the responder device merely as a tool in its ordinary capacity to perform an existing process (i.e., sending data), which amounts to no more than a recitation of the words "apply it" (or an equivalent) and only generally links the claimed invention to a particular technological environment or field of use (i.e., computer technology), which does not impose meaningful limits on the scope of the claim. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements individually. The 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. Accordingly, the claims are directed to an abstract idea.
Reevaluated under step 2B, the additional elements noted above do not provide “significantly more” when taken either individually or as an ordered combination. The use of a general purpose computer or computers (i.e., an inventory system including one or more databases; a central platform including a database, one or more processors) amounts to no more than mere instructions to apply the exception using generic computer components and does not impose any meaningful limitation on the computer implementation of the abstract idea, so it does not amount to significantly more than the abstract idea. Also, “a medical device configured to selectively provide treatment to a patient, wherein the medical device has a size or a type corresponding to the patient” and “wherein the medical device is configured to: enable, based on a fitment of the medical device on the patient, monitoring of the patient for a medical event; and upon detecting that the medical event is being experienced by the patient, control discharge circuitry of the medical device to deliver a therapy to the patient for the treatment of the medical event, wherein an effectiveness of the delivered therapy is related to an accuracy of the fitment of the medical device on the patient” only invokes the medical device merely as a tool in its ordinary capacity to perform an existing process (i.e., monitoring, administering therapy), which amounts to no more than a recitation of the words "apply it" (or an equivalent) and only generally links the claimed invention to a particular technological environment or field of use, which does not impose meaningful limits on the scope of the claim. Also, the limitations of “enable, based on a fitment of the medical device on the patient, monitoring of the patient for a medical event; and upon detecting that the medical event is being experienced by the patient, control discharge circuitry of the medical device to deliver a therapy to the patient for the treatment of the medical event, wherein an effectiveness of the delivered therapy is related to an accuracy of the fitment of the medical device on the patient” is determined to constitute well-understood, routine, and conventional elements/functions. As evidenced by US 2020/0105404 A1 (hereinafter referred to as "Major") (Major: ¶ 0003; ¶ 0175; ¶ 0180) and US 2012/0191476 A1 (hereinafter referred to as "REID") (REID: ¶ 0475), using a medical device to administer therapy is well-understood, routine, and conventional and thus, cannot provide “significantly more.” Furthermore, receiving or transmitting data over a network has been recognized by the courts as well-understood, routine, and conventional elements/functions. See: MPEP § 2106.05(d)(II). Also, “one or more responder devices associated with one or more responders qualified to assist the patient in using the medical device” only invokes the responder device merely as a tool in its ordinary capacity to perform an existing process (i.e., sending data), which amounts to no more than a recitation of the words "apply it" (or an equivalent) and only generally links the claimed invention to a particular technological environment or field of use (i.e., computer technology), which does not impose meaningful limits on the scope of the claim. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements individually. The combination of elements does not indicate a significant improvement to the functioning of a computer or any other technology and their collective functions merely provide a conventional computer implementation of the abstract idea. Furthermore, the additional elements or combination of elements in the claims, other than the abstract idea per se, amount to no more than a recitation of generally linking the abstract idea to a particular technological environment or field of use, as the courts have found in Parker v. Flook; similarly, the current invention merely limits the claimed calculations to the healthcare industry which does not impose meaningful limits on the scope of the claim. Therefore, there are no limitations in the claims that transform the judicial exception into a patent eligible application such that the claims amount to significantly more than the judicial exception.
Dependent claims 2-14, 16-20 include all the limitations of the parent claims and further elaborate on the abstract idea discussed above and incorporated herein.
Claims 2, 6, 9-14, 16-20 further define the analysis and organization of data for the performance of the abstract idea and do not recite any additional elements. Thus, the claims do not integrate the abstract idea into a practical application and do not provide “significantly more.”
Claim 3 further recites the additional elements of “wherein the medical device includes a wearable support structure that maintains the medical device in a predefined position on a body of the patient when the patient is wearing the medical device,” which does not impose meaningful limits on the scope of the claim because the medical device with a wearable support structure is still invoked merely as a tool in its ordinary capacity to perform an existing process (i.e., monitoring, administering therapy), which amounts to no more than a recitation of the words "apply it" (or an equivalent) and only generally links the claimed invention to a particular technological environment or field of use. Also, functional limitations further define the analysis and organization of data for the performance of the abstract idea. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements individually. Thus, the claims as a whole do not integrate the abstract idea into a practical application and do not provide “significantly more.”
Claims 4-5 further recites the additional elements of “wherein the medical device comprises a user interface to receive an input from the patient to prevent the delivery of the therapy to the patient” and “wherein the user interface is configured to provide visual feedback to the user for resuscitation attempts,” which does not impose meaningful limits on the scope of the claim because the medical device with a user interface is still invoked merely as a tool in its ordinary capacity to perform an existing process (i.e., receiving, providing data), which amounts to no more than a recitation of the words "apply it" (or an equivalent) and only generally links the claimed invention to a particular technological environment or field of use. Also, functional limitations further define the analysis and organization of data for the performance of the abstract idea. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements individually. Thus, the claims as a whole do not integrate the abstract idea into a practical application and do not provide “significantly more.”
Claim 7 further recites the additional elements of “wherein the medical device item comprises the medical device, and wherein the medical device is a defibrillator,” which does not impose meaningful limits on the scope of the claim because the defibrillator is still invoked merely as a tool in its ordinary capacity to perform an existing process (i.e., administering therapy), which amounts to no more than a recitation of the words "apply it" (or an equivalent) and only generally links the claimed invention to a particular technological environment or field of use. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements individually. Thus, the claims as a whole do not integrate the abstract idea into a practical application and do not provide “significantly more.”
Claim 8 further recites the additional elements of “wherein the responder device comprises an interface,” which does not impose meaningful limits on the scope of the claim because the responder device with an interface is still invoked merely as a tool in its ordinary capacity to perform an existing process (i.e., receiving, providing data), which amounts to no more than a recitation of the words "apply it" (or an equivalent) and only generally links the claimed invention to a particular technological environment or field of use. Also, functional limitations further define the analysis and organization of data for the performance of the abstract idea. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements individually. Thus, the claims as a whole do not integrate the abstract idea into a practical application and do not provide “significantly more.”
Although the dependent claims add additional limitations, they only serve to further limit the abstract idea by reciting limitations on what the information is and how it is received and used. These information characteristics do not change the fundamental analogy to the abstract idea grouping of “Certain Methods of Organizing Human Activity,” and, when viewed individually or as a whole, they do not add anything substantial beyond the abstract idea. Furthermore, the combination of elements does not indicate a significant improvement to the functioning of a computer or any other technology. Therefore, the claims when taken as a whole are ineligible for the same reasons as the independent 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.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2020/0105404 A1 (hereinafter referred to as "Major") in view of U.S. Patent App. Pub. No. US 2019/0122760 A1 (hereinafter referred to as "Wang") and U.S. Patent App. Pub. No. US 2017/0056682 A1 (hereinafter referred to as "KUMAR").
Regarding (currently amended) claim 1, Major teaches a medical product resource management system, comprising:
a medical device configured to selectively provide treatment to a patient, wherein the medical device has a size or type corresponding to the patient (Major: ¶ 0097, i.e., “the prescription parameters may call for a wearable cardiac device to include one or more pacing or defibrillating routines to be applied in response to a respective cardiac event”);
one or more responder devices associated with one or more responders (Major: ¶ 0112, i.e., “A medical service person 570 uses a mobile device 560”) qualified to assist the patient in using the medical device (Major: ¶ 0121-0122);
an inventory system including one or more databases configured to identify a plurality of medical device items, including a size or type of each of the plurality of medical device items, available to at least one of the one or more responders (Major: ¶ 0093, i.e., “an inventory storage 320 configured to store information about the medical device inventory on hand at the depot location. Such information may include identifiers of individual components (e.g., serial or inventory number), as well as their type (e.g., defibrillator), make, model, size, location within the depot (e.g., aisle, shelf, rack, etc. designated by a predetermined reference scheme), version (e.g., firmware version), expiration date, next service date, and deployment status”); and
a central platform (Major: ¶ 0112, i.e., “central server 550”)…, at least one responder profile associated with a corresponding responder, the responder profile including information that identifies one or more characteristics of the one or more responders, the one or more characteristics including a qualification of the one or more responders to assist the patient with the medical device (Major: ¶ 0121, i.e., “the medical service personnel information includes information about one or more medical service persons”; ¶ 0122, i.e., “the medical service person's authorization to perform certain assignments, or the medical service person's access rights to one or more depot locations. For example, a medical service person may…be suitably trained or authorized to assign a wearable cardiac device to a new patient and instruct the patient on its use”),
wherein the central platform comprises one or more processors (Major: ¶ 0112, i.e., “The central server includes a processor 552”) configured to:
match a responder of the one or more responders based on a service request received to render assistance to the patient with a medical device item, of the plurality of medical device items, having the size or the type corresponding to the service request (Major: ¶ 0096, i.e., “”; ¶ 0108), wherein to match the responder, the one or more processors are configured to:
determine availability of the one or more responders based on at least one of the one or more characteristics including a location of the one or more responders (Major: ¶ 0121, i.e., “The central server may determine the suitability of the medical service person according to a number of predetermined personnel criteria, including…location of the patient and/or medical service personnel”; ¶ 0123, i.e., “the central server may identify the most suitable medical service persons, and may selectively offer the assignment to the most suitable first…the server may automatically identify the most suitable medical service person or persons based on a series of configurable rules stored in a memory associated with the central server. For example, the rules may specify based on certain types of fields in the prescription parameters the type of medical service person to be assigned to the patient”; ¶ 0159); and
receive a reply from at least one matching responder from the available one or more responders via a responder device of the at least one matching responder, in response to a notification communicated to the one or more responders (Major: ¶ 0116, i.e., “The medical service person's interactions with the central server, the depot device(s), and other components as described herein may be performed through a mobile application (“app”) executed on the mobile device”; ¶ 0125, i.e., “the medical service person either accepts…the assignment, with the acceptance or rejection being transmitted by the mobile device to the central server”; ¶ 0126, i.e., “if the medical service person has accepted the assignment, the prescription/patient are assigned to the medical service person, and the assignment is confirmed to the medical service person”);
verify, from the one or more databases of the inventory system, whether a medical device item in the at least one matching responder's inventory is of the size or the type corresponding to the service request (Major: ¶ 0108, i.e., “the central server 450 requests and receives from a depot site (e.g., one associated with depot device 410b) inventory information at that depot location, including information indicative of whether the required device and components are at the depot location and available. If the necessary inventory is available at that depot location, the central server 450 may transmit to one or more medical service persons 470a-c a request that the equipment be retrieved from the appropriate depot location”; ¶ 0127, i.e., “If more than one of those medical service persons indicates a willingness to accept the assignment, then the central server 450 may pick from among those accepting medical service persons based on who is closest to the depot and/or the patient”; ¶ 0128); and
schedule an appointment between the at least one matching responder and the patient to provide the medical device item verified in the at least one matching responder's inventory and to assist in fitting the medical device on the patient by the at least one matching responder (Major: ¶ 0136-0137; ¶ 0138, i.e., “a schedule field 924 that the medical service person can interact with to schedule an appointment with or contact the patient”),
Yet, Major does not explicitly teach, but Wang teaches, in the same field of endeavor,
a central platform including a database of responder profiles (Wang: figure 1, i.e., “Server” 102 includes “Database” 108; ¶ 0082, i.e., “Database(s) 108 can store…caregiver data…Caregiver data can include caregivers' profiles”; ¶ 0083)…;
Therefore, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to include a central platform including a database of responder profiles, as taught by Wang, within the system of Major, with the motivation of “to provide and maintain a prescheduled service application in order to dispatch a compatible caregiver based on a patient's preferences and needs” (Wang: ¶ 0084).
Yet, Major and Wang do not explicitly teach, but KUMAR teaches, in the same field of endeavor,
wherein the medical device is configured to:
enable, based on a fitment of the medical device on the patient, monitoring of the patient for a medical event (KUMAR: ¶ 0189-0190); and
upon detecting that the medical event is being experienced by the patient, control discharge circuitry of the medical device to deliver a therapy to the patient for the treatment of the medical event (KUMAR: ¶ 0190, i.e., “Based on the analysis of the patient data…If the patient is determined to have a treatable arrhythmia then the wearable defibrillator can provide a therapeutic shock to the patient”), wherein an effectiveness of the delivered therapy is related to an accuracy of the fitment of the medical device on the patient (KUMAR: ¶ 0190, i.e., “the transthoracic impedance of the patient between the first defibrillator pad electrode and the second defibrillator pad electrode can be measured prior to delivering the electrical shock. The impedance can be measured to confirm proper electrical contact and to tailor the characteristics of the waveform based on the transthoracic impedance to deliver the desired amount of electrical energy to the patient”; ¶ 0191).
Therefore, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to include wherein the medical device is configured to:
enable, based on a fitment of the medical device on the patient, monitoring of the patient for a medical event; and upon detecting that the medical event is being experienced by the patient, control discharge circuitry of the medical device to deliver a therapy to the patient for the treatment of the medical event, wherein an effectiveness of the administered therapy is related to an accuracy of a fitment of the medical device on the patient, as taught by KUMAR, with the system of Major and Wang, with the motivation “to determine if the patient may be in need of a treatment or if the device may need to be adjusted or replaced” (KUMAR: ¶ 0189).
Regarding (currently amended) claim 2, Major, Wang, and KUMAR teach the medical product resource management system of claim 1, wherein one or more readings acquired by the medical device are based on the fitment of the medical device (KUMAR: ¶ 0187; ¶ 0189-0190).
The obviousness of combining the teachings of Major, Wang, and KUMAR are discussed in the rejection of claim 1, and incorporated herein.
Regarding (currently amended) claim 3, Major, Wang, and KUMAR teach the medical product resource management system of claim 1, wherein the medical device includes a wearable support structure that maintains the medical device in a predefined position on a body of the patient when the patient is wearing the medical device (Major: figure 13, i.e., medical device 1300 includes garment 1310, belt 1350; ¶ 0176), and wherein the wearable support structure is adjustable to assist in the fitment of the medical device on the patient (Major: figure 13, i.e., garment 1310 and belt 1350 can be adjusted via hooks and fasteners; ¶ 0177).
The obviousness of combining the teachings of Major, Wang, and KUMAR are discussed in the rejection of claim 1, and incorporated herein.
Regarding (currently amended) claim 4, Major, Wang, and KUMAR teach the medical product resource management system of claim 1, wherein the medical device comprises a user interface to receive an input from the patient to prevent the delivery of the therapy to the patient (Major: ¶ 0181, i.e., “an authorized person can access a protected user interface of the medical device and select a preconfigured option or perform some other user action via the user interface to deactivate the therapeutic elements of the medical device”).
Regarding (currently amended) claim 5, Major, Wang, and KUMAR teach the medical product resource management system of claim 4.
Yet, Major, Wang, and KUMAR do not explicitly teach, but KUMAR teaches, in the same field of endeavor, wherein the user interface is configured to provide feedback (KUMAR: ¶ 0226, i.e., under broadest reasonable interpretation, a person having ordinary skill in the art would have understood the “small visual display” of KUMAR as the “user interface” of Major, which is the claimed user interface) for resuscitation attempts (Examiner interprets this limitation as not patentably distinguishing the claimed invention from the cited prior art because it merely recites a statement of purpose, which is not given weight when it simply expresses the intended result or natural consequence of the recited “provide feedback”).
Therefore, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to include wherein the user interface is configured to provide feedback for resuscitation attempts, as taught by KUMAR, with the system of Major, Wang, and KUMAR, with the motivation “to provide information and/or instructions to the user” (KUMAR: ¶ 0226).
Regarding (currently amended) claim 6, Major, Wang, and KUMAR teach the medical product resource management system of claim 1, wherein the central platform is configured to determine the location of the at least one matching responder based on a geographic proximity to the patient, and wherein the matching of the at least one matching responder is prioritized at least in part based on the location of the at least one matching responder and a severity of the medical event (Major: ¶ 0069; ¶ 0121-0123; ¶ 0127).
Regarding (currently amended) claim 7, Major, Wang, and KUMAR teach the medical product resource management system of claim 1, wherein the medical device item comprises the medical device, and wherein the medical device is a defibrillator (Major: ¶ 0097; ¶ 0176).
Regarding (currently amended) claim 8, Major, Wang, and KUMAR teach the medical product resource management system of claim 1, wherein the responder device comprises an interface configured to enable the at least one matching responder to communicate with the patient via the central platform (Major: figure 9, i.e., interface 920 includes “Tap to contact patient” 924; ¶ 0133, i.e., “A block diagram of a mobile device 760 (e.g., such as mobile device 560 for use by a medical service person) is shown in FIG. 7…The mobile device 760 includes… a network interface 766, and a user interface 768”; ¶ 0134, i.e., “an example user interface 810 in which a mobile device of a medical service person (e.g., mobile device 760)”; ¶ 0137, i.e., “In the interface 910 shown in FIG. 9, the medical service person is presented with various options discussed above with respect to interface 810”) to provide training to the patient on how to position and wear the medical device (Examiner interprets this limitation as not patentably distinguishing the claimed invention from the cited prior art because it merely recites a statement of purpose, which is not given weight when it simply expresses the intended result or natural consequence of the recited “allow the at least one matching responder to communicate with the patient via the central platform”).
Regarding (currently amended) claim 9, Major, Wang, and KUMAR teach the medical product resource management system of claim 1.
Yet, Major, Wang, and KUMAR do not explicitly teach, but Wang teaches, in the same field of endeavor, wherein the central platform is configured to receive the service request from the patient who has been given a prescription (Wang: ¶ 0003, i.e., under broadest reasonable interpretation, a person having ordinary skill in the art would have understood the “service requests received from…patients” of Wang as the “prescription or new electronic order for one or more patients…input by a… authorized person after a new medical order is received from an attending, consulting, or other physician responsible for the patient” of Major, which is the information included in the claimed service request).
Therefore, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to include wherein the central platform is configured to receive the service request from the patient who has been given a prescription, as taught by Wang, with the system of Major, Wang, and KUMAR, with the motivation of “[to] enable patients or caregivers to prioritize their categories of preferences or limitations, respectively, in order to further resolve any conflicts arising during the prescheduling process and facilitate automated matching and scheduling” (Wang: ¶ 0018).
Regarding (currently amended) claim 10, Major, Wang, and KUMAR teach the medical product resource management system of claim 1.
Yet, Major, Wang, and KUMAR do not explicitly teach, but Wang teaches, in the same field of endeavor, wherein the service request includes one or more time slots during which the patient is available for the appointment (Wang: ¶ 0094, i.e., under broadest reasonable interpretation, a person having ordinary skill in the art would have understood the “service details such as pick-up and drop-off locations as well as desired pick-up and visit end times” in the “service request” of Wang as the “the prescription parameters” of Major, which is the information included in the claimed service request).
Therefore, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to include wherein the service request includes one or more time slots during which the patient is available for the appointment, as taught by Wang, with the system of Major, Wang, and KUMAR, with the motivation of “[to] enable patients or caregivers to prioritize their categories of preferences or limitations, respectively, in order to further resolve any conflicts arising during the prescheduling process and facilitate automated matching and scheduling” (Wang: ¶ 0018).
Regarding (currently amended) claim 11, Major, Wang, and KUMAR teach the medical product resource management system of claim 1, wherein the service request includes information indicative of physical measurements of the patient (Major: ¶ 0070, i.e., “prescription parameters can include…[the patient’s] identifying characteristics and biometric information…the patient's size and fit”).
Regarding (currently amended) claim 12, Major, Wang, and KUMAR teach the medical product resource management system of claim 1, wherein the service request includes information indicative of a medical history of the patient (Major: ¶ 0070, i.e., “prescription parameters can include…the patient's underlying medical condition”).
Regarding (currently amended) claim 13, Major, Wang, and KUMAR teach the medical product resource management system of claim 1.
Yet, Major, Wang, and KUMAR do not explicitly teach, but Wang teaches, in the same field of endeavor, wherein the service request includes information indicative of the patient's preferences for the responder of the one or more responders (Wang: ¶ 0130, i.e., under broadest reasonable interpretation, a person having ordinary skill in the art would have understood “the service request [requiring] that the caregiver be fluent in a particular language” of Wang as the “prescription parameters” of Major, which is the information included in the claimed service request; ¶ 0166).
Therefore, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to include wherein the service request includes information indicative of the patient's preferences for the responder of the one or more responders, as taught by Wang, with the system of Major, Wang, and KUMAR, with the motivation of “[to] enable patients or caregivers to prioritize their categories of preferences or limitations, respectively, in order to further resolve any conflicts arising during the prescheduling process and facilitate automated matching and scheduling” (Wang: ¶ 0018).
Regarding (original) claim 14, Major, Wang, and KUMAR teach the medical product resource management system of claim 13, wherein the patient's preferences includes one or more of language fluency, gender, and/or experience in providing assistance to use the medical device (Wang: ¶ 0130, i.e., “the service request requires that the caregiver be fluent in a particular language”; ¶ 0166).
The obviousness of combining the teachings of Major, Wang, and KUMAR are discussed in the rejection of claim 13, and incorporated herein.
Regarding (currently amended) claim 15, claim 15 recites substantially similar limitations analogous to those already addressed in claim 1, and thus, claim 15 is similarly analyzed and rejected in a manner consistent with the rejection of claim 1.
Regarding (currently amended) claim 16, claim 16 recites substantially similar limitations analogous to those already addressed in claim 13, and thus, claim 16 is similarly analyzed and rejected in a manner consistent with the rejection of claim 13.
Regarding (currently amended) claim 17, Major, Wang, and KUMAR teach the method of claim 16, wherein the patient's preference or preferences includes language fluency (Wang: ¶ 0130, i.e., “the service request requires that the caregiver be fluent in a particular language”; ¶ 0166).
The obviousness of combining the teachings of Major, Wang, and KUMAR are discussed in the rejection of claim 13, and incorporated herein.
Regarding (currently amended) claim 18, Major, Wang, and KUMAR teach the method of claim 16, wherein the patient's preference or preferences includes a gender for the responder (Wang: ¶ 0166, i.e., “Preset preferences for a patient…can include, but are not limited to, preferences related to…gender… Gender preference allows a patient to choose a caregiver of a certain gender”).
The obviousness of combining the teachings of Major, Wang, and KUMAR are discussed in the rejection of claim 13, and incorporated herein.
Regarding (currently amended) claim 19, Major, Wang, and KUMAR teach the method of claim 16, wherein the patient's preference or preferences includes experience in providing assistance on using the medical device (Wang: ¶ 0166, i.e., “Preset preferences for a patient…can include, but are not limited to, preferences related to… care experience… Years of experience preference allows a patient to preset the number of years' experience he/she may prefer his/her caregiver to have”).
The obviousness of combining the teachings of Major, Wang, and KUMAR are discussed in the rejection of claim 13, and incorporated herein.
Regarding (currently amended) claim 20, Major, Wang, and KUMAR teach the method of claim 15, wherein the medical device item comprises the medical device, and wherein the medical device is a defibrillator (Major: ¶ 0097; ¶ 0176).
Response to Arguments
Applicant's arguments filed 05/18/2026 have been fully considered but they are not persuasive. Applicant’s arguments will be addressed hereinbelow in the order in which they appear in the response filed 05/18/2026.
In the remarks, Applicant argues in substance that:
Regarding the 112(a) rejections, the amendments overcome the rejections.
Regarding the 101 rejections,
“the features of monitoring the patient for a medical event, and upon detection of the medical event, controlling discharge circuitry of the medical device to deliver a therapy to the patient for the treatment of the medical event, such that the effectiveness of the delivered therapy is related to the accuracy of fitting the medical device, as recited in amended claims 1 and 15 and their dependent claims, are directed to a system for treatment. In particular, the medical device is accurately fitted for implementing an effective treatment for the patient experiencing the medical event. Implementation of Applicant's claimed technology constitutes a particular treatment or prophylaxis for a medical condition/event”;
“the claimed subject matter inextricably requires "one or more processors" for accessing remote databases including information of available medical device items with each responder, monitoring health parameters of the patient to detect an health event/condition, and further controlling a discharge circuitry to deliver a therapy to the patient to treat the heath condition, which cannot possibly be a method of organizing human activity. Therefore, the claimed features are inextricably tied to a machine and do not represent "certain methods of organizing human activity"”; and
“amended claim 1 provides a specific, structured, and technical solution for efficiently providing skilled and trained patient service responders for proper fitment of a medical device, e.g., a Wearable Cardioverter Defibrillator (WCD). Particularly, the solution relates to immediate and efficient provision of a trained patient service responder based on a plurality of characteristics of the responders or preferences of the patient and further related to provision of highly effective therapy to the patient based on the fitting of the WCD by the patient service responder…Amended independent claim 1 achieves a concrete technological improvement in the field of medical product resource management.”
Regarding the 103 rejections, the cited prior art reference(s) fails to teach the amended claim limitations (i.e., “verify, from the one or more databases of the inventory system, whether a medical device item in the responder's inventory is of the size or the type corresponding to the service request”) because “the meaning of "depot" as disclosed in Major would be warehouses that service particular neighborhoods or districts. As such, Major's depots apparently contain inventory that is not a particular medical service person's inventory but rather is for a geographical area…"depots" as disclosed in Major are not equivalent to "PSR inventory" as recited in claim 1; rather, Major's "depots" are more similar to warehouses or inventory storage locations mentioned in the present application.”
It is respectfully submitted that Examiner has considered Applicant’s arguments and does not find them persuasive. Examiner has attempted to address all of the arguments presented by Applicant; however, any arguments inadvertently not addressed are not persuasive for at least the following reasons:
In response to Applicant’s argument that (a) regarding the 112(a) rejections, the amendments overcome the rejections:
It is respectfully submitted that Examiner withdraws the aforementioned 112(a) rejections of Office Action dated 02/17/2026 because the amendments have rendered the rejections moot.
In response to Applicant’s argument that (b) regarding the 101 rejections,
“the features of monitoring the patient for a medical event, and upon detection of the medical event, controlling discharge circuitry of the medical device to deliver a therapy to the patient for the treatment of the medical event, such that the effectiveness of the delivered therapy is related to the accuracy of fitting the medical device, as recited in amended claims 1 and 15 and their dependent claims, are directed to a system for treatment. In particular, the medical device is accurately fitted for implementing an effective treatment for the patient experiencing the medical event. Implementation of Applicant's claimed technology constitutes a particular treatment or prophylaxis for a medical condition/event”:
It is respectfully submitted that per broadest reasonable interpretation of the claim in light of the specification, the claims of the present invention encompass the activity of (to paraphrase) rules or instructions to help a provider match with a patient and fit a medical device to the patient, which covers the sub-grouping of managing personal behavior or relationships or interactions between people in the “Certain Methods of Organizing Human Activity” grouping of abstract ideas. Put another way, the claimed invention amounts to a series of rules or steps that a user (i.e., coordinator) would follow to collect and match a patient with a service provider to fit a medical device to the patient. This is an abstract idea. That the steps are performed on a well-known, general purpose computer (i.e., an inventory system including one or more databases; a central platform including a database, one or more processors) does not remove the invention from being directed to an abstract idea.
Applicant argues “the features of monitoring the patient for a medical event, and upon detection of the medical event, controlling discharge circuitry of the medical device to deliver a therapy to the patient for the treatment of the medical event, such that the effectiveness of the delivered therapy is related to the accuracy of fitting the medical device, as recited in amended claims 1 and 15 and their dependent claims, are directed to a system for treatment. In particular, the medical device is accurately fitted for implementing an effective treatment for the patient experiencing the medical event. Implementation of Applicant's claimed technology constitutes a particular treatment or prophylaxis for a medical condition/event.” However, there is no particularity within the meaning of Vanda to overcome the 101 rejection. Per MPEP § 2106.04(d)(2)(a): “the claim limitation in question must affirmatively recite an action that effects a particular treatment or prophylaxis for a disease or medical condition. An example of such a limitation is a step of "administering amazonic acid to a patient" or a step of "administering a course of plasmapheresis to a patient." If the limitation does not actually provide a treatment or prophylaxis, e.g., it is merely an intended use of the claimed invention or a field of use limitation, then it cannot integrate a judicial exception under the "treatment or prophylaxis" consideration.”
Furthermore, “a medical device configured to selectively provide treatment to a patient, wherein the medical device has a size or a type corresponding to the patient” and “wherein the medical device is configured to: enable, based on a fitment of the medical device on the patient, monitoring of the patient for a medical event; and upon detecting that the medical event is being experienced by the patient, control discharge circuitry of the medical device to deliver a therapy to the patient for the treatment of the medical event, wherein an effectiveness of the delivered therapy is related to an accuracy of the fitment of the medical device on the patient” only invokes the medical device merely as a tool in its ordinary capacity to perform an existing process (i.e., monitoring, administering therapy), which amounts to no more than a recitation of the words "apply it" (or an equivalent) and only generally links the claimed invention to a particular technological environment or field of use, which does not impose meaningful limits on the scope of the claim. Furthermore, adding a step of “enable, based on a fitment of the medical device on the patient, monitoring of the patient for a medical event; and upon detecting that the medical event is being experienced by the patient, control discharge circuitry of the medical device to deliver a therapy to the patient for the treatment of the medical event, wherein an effectiveness of the delivered therapy is related to an accuracy of the fitment of the medical device on the patient” to a process that only recites helping a provider match with a patient and fit a medical device to the patient does not add a meaningful limitation to the process of matching a patient with a provider and scheduling between the respective parties, and as such, amounts to insignificant extrasolution activity. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements individually. The 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. Reevaluated under Step 2B, “a medical device configured to selectively provide treatment to a patient, wherein the medical device has a size or a type corresponding to the patient” and “wherein the medical device is configured to: enable, based on a fitment of the medical device on the patient, monitoring of the patient for a medical event; and upon detecting that the medical event is being experienced by the patient, control discharge circuitry of the medical device to deliver a therapy to the patient for the treatment of the medical event, wherein an effectiveness of the delivered therapy is related to an accuracy of the fitment of the medical device on the patient” only invokes the medical device merely as a tool in its ordinary capacity to perform an existing process (i.e., monitoring, administering therapy), which amounts to no more than a recitation of the words "apply it" (or an equivalent) and only generally links the claimed invention to a particular technological environment or field of use, which does not impose meaningful limits on the scope of the claim. Also, the limitations of “enable, based on a fitment of the medical device on the patient, monitoring of the patient for a medical event; and upon detecting that the medical event is being experienced by the patient, control discharge circuitry of the medical device to deliver a therapy to the patient for the treatment of the medical event, wherein an effectiveness of the delivered therapy is related to an accuracy of the fitment of the medical device on the patient” is determined to constitute well-understood, routine, and conventional elements/functions. As evidenced by US 2020/0105404 A1 (hereinafter referred to as "Major") (Major: ¶ 0003; ¶ 0175; ¶ 0180) and US 2012/0191476 A1 (hereinafter referred to as "REID") (REID: ¶ 0475), using a medical device to administer therapy is well-understood, routine, and conventional and thus, cannot provide “significantly more.” Furthermore, receiving or transmitting data over a network has been recognized by the courts as well-understood, routine, and conventional elements/functions. See: MPEP § 2106.05(d)(II). Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements individually. Therefore, there are no limitations in the claims that transform the judicial exception into a patent eligible application such that the claims amount to significantly more than the judicial exception.
“the claimed subject matter inextricably requires "one or more processors" for accessing remote databases including information of available medical device items with each responder, monitoring health parameters of the patient to detect an health event/condition, and further controlling a discharge circuitry to deliver a therapy to the patient to treat the heath condition, which cannot possibly be a method of organizing human activity. Therefore, the claimed features are inextricably tied to a machine and do not represent "certain methods of organizing human activity"”:
Applicant argues “a “polyglot healthcare information system” that solves the concrete, real-world problem of medical record interoperability across healthcare systems, institutions, and countries.” However, Applicant fails to point to the claim limitations to which Applicant seem to refer. Regardless, it is noted that the features upon which applicant relies (i.e., a “polyglot healthcare information system”) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Furthermore, the computing system did not cause the argued problem (i.e., “medical record interoperability”) and thus it is not a technical problem caused by the technological environment to which the claims are confined (i.e., a well-known, general purpose computer). While the specification need not explicitly set forth the improvement, the disclosure does not provide sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing any technical improvement or any physical improvement to the computer. See MPEP § 2106.04(d)(1) and 2106.05(a).
Applicant argues “The system uses these mappings to automatically translate a patient’s medical records from the coding standard of the patient’s system into the standard required by the clinician’s system (see Specification at paragraph [0130]), enabling a patient presenting at any healthcare facility to have their records accurately interpreted and used by the treating clinician. This is a specific, technical solution to a recognized interoperability challenge in healthcare informatics, not a generic “apply it” instruction. The optical-code delivery mechanism further provides a specific solution to resolving security issues associated with patient-controlled health record access.” However, the claim limitations to which Applicant seem to refer as the “mappings” (i.e., “using a mapping to translate the first medical information to obtain second medical information that is encoded in accordance with a second coding scheme”) and “optical-code delivery mechanism” are interpreted as rules or instructions to access and exchange healthcare information between users, which is the abstract idea, and not additional elements to be interpreted in Step 2A, Prong Two. Furthermore, "enabling a patient presenting at any healthcare facility to have their records accurately interpreted and used by the treating clinician" and “resolving security issues associated with patient-controlled health record access” addresses administrative problems, and not a technical problem to any specific devices, technology, or computers for that matter, and thus, the claims do not provide a technical solution. For example, the computing system did not cause the argued problem and thus it is not a technical problem caused by the technological environment to which the claims are confined. Even if the claims provide the alleged improvements, any alleged benefits of the invention are at best, an improvement to the abstract idea of rules or instructions to access and exchange healthcare information between users. However, an improved abstract idea is still an abstract idea and the claims do not provide a technical improvement.
Thus, the claims are directed to an abstract idea.
“amended claim 1 provides a specific, structured, and technical solution for efficiently providing skilled and trained patient service responders for proper fitment of a medical device, e.g., a Wearable Cardioverter Defibrillator (WCD). Particularly, the solution relates to immediate and efficient provision of a trained patient service responder based on a plurality of characteristics of the responders or preferences of the patient and further related to provision of highly effective therapy to the patient based on the fitting of the WCD by the patient service responder…Amended independent claim 1 achieves a concrete technological improvement in the field of medical product resource management”:
Applicant argues “a specific, structured, and technical solution for efficiently providing skilled and trained patient service responders for proper fitment of a medical device, e.g., a Wearable Cardioverter Defibrillator (WCD). Particularly, the solution relates to immediate and efficient provision of a trained patient service responder based on a plurality of characteristics of the responders or preferences of the patient and further related to provision of highly effective therapy to the patient based on the fitting of the WCD by the patient service responder…Amended independent claim 1 achieves a concrete technological improvement in the field of medical product resource management.” However, ” efficiently providing skilled and trained patient service responders for proper fitment of a medical device,” “immediate and efficient provision of a trained patient service responder,” and “medical product resource management” addresses administrative problems, not a technical problem, and thus, the claims do not provide a technical solution. Even if the claims provide the aforementioned alleged improvements, these alleged benefits are at best, an improvement to the abstract idea of rules or instructions to help a provider match with a patient and fit a medical device to the patient. However, an improved abstract idea is still an abstract idea.
While the specification need not explicitly set forth the improvement, the disclosure does not provide sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement. See MPEP § 2106.04(d)(1) and 2106.05(a). The computing system did not cause the argued problem and thus it is not a technical problem caused by the technological environment to which the claims are confined (i.e., a well-known, general purpose computer). The disclosure does not provide sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing a physical improvement to the computer, either. See MPEP § 2106.04(d)(1) and 2106.05(a). Examiner notes that even a technical solution to a nontechnical problem does not integrate the judicial exception into a practical application.
Thus, the claim as a whole does not integrate the recited judicial exception into a practical application.
Reevaluated under step 2B, the additional elements noted above do not provide “significantly more” when taken either individually or as an ordered combination.
Thus, the claim as a whole does not amount to significantly more than the judicial exception.
Thus, Examiner maintains the 101 rejections of claims 1-20, which have been updated to address Applicant’s remarks and to comply with the 2019 Revised Patent Subject Matter Eligibility Guidance and the 2024 Guidance Update on Patent Subject Matter Eligibility, Including on Artificial Intelligence in the above Office Action.
In response to Applicant’s argument that (c) regarding the 103 rejections, the cited prior art reference(s) fails to teach the amended claim limitations (i.e., “verify, from the one or more databases of the inventory system, whether a medical device item in the responder's inventory is of the size or the type corresponding to the service request”) because “the meaning of "depot" as disclosed in Major would be warehouses that service particular neighborhoods or districts. As such, Major's depots apparently contain inventory that is not a particular medical service person's inventory but rather is for a geographical area…"depots" as disclosed in Major are not equivalent to "PSR inventory" as recited in claim 1; rather, Major's "depots" are more similar to warehouses or inventory storage locations mentioned in the present application””:
It is respectfully submitted that Applicant argues “the meaning of "depot" as disclosed in Major would be warehouses that service particular neighborhoods or districts. As such, Major's depots apparently contain inventory that is not a particular medical service person's inventory but rather is for a geographical area…"depots" as disclosed in Major are not equivalent to "PSR inventory" as recited in claim 1; rather, Major's "depots" are more similar to warehouses or inventory storage locations mentioned in the present application.”” However, Applicant fails to specify how “"depots" as disclosed in Major are not equivalent to "PSR inventory" as recited in claim 1.” Per broadest reasonable interpretation in light of the specification, even if “Major's depots…contain inventory…for a geographical area,” the inventory of Major’s depots are the inventory of the claimed “matching responder's inventory” because “The medical service person 470b may be instructed to proceed to the depot location and interact with the depot device located there (e.g., depot device 410b) and/or the equipment and components there in order to customize the necessary equipment for the patient. The medical service person 470b can then take possession of the equipment and deliver it to the patient 480b” (Major: ¶ 0108).
Examiner has updated passages and citations to the amended claims and applied new passages and citations accordingly, at the present time, as addressed in the above Office Action, and the analogous independent claims and the remaining dependent claims have been taught by the applied/recited passages and citations, as addressed in the above Office Action.
Thus, the cited prior art references teach the aforementioned amended claim limitations.
Conclusion
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Emily Huynh whose telephone number is (571)272-8317. The examiner can normally be reached on M-Th 8-5 PM.
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/EMILY HUYNH/Primary Examiner, Art Unit 3683
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