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 .
DETAILED ACTION
This action is in reference to the communication filed on 31 MARCH 2026.
Amendments to claims 1, 30, entered and considered, as is the addition of claim 69.
Claims 1-16, 18, 19, 30, 68, 69 are present and have been examined.
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 1-16, 18, 19, 30, 68, 69 rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. As explained below, the claim(s) are directed to an abstract idea without significantly more.
Step One: Is the Claim directed to a process, machine, manufacture or composition of matter? YES
With respect to claim(s) 1-16, 18, 19, 30, 68, 69 the independent claim(s) 1, 30 recite(s) a method and system, both of which fall into a statutory category of invention.
Step 2A – Prong One: Is the claim directed to a law of nature, a natural phenomenon (product of nature) or an abstract idea? YES
With respect to claim(s) 1-16, 18, 19, 30, 68, 69 the independent claim(s) (claims 1, 30) is/are directed, in part, to “receiving first information characterizing a health condition of a patient; retrieving…a generic model which receives, as an input, medication information and provides a generic configuration…and wherein the generic model is automatically identified from a plurality of generic models, the identification based on at least one programming parameter for the medical device, the at least one programming parameter including an initial dosage for the medication to be administered to the patient; generating based on the generic health model and the health condition of the patient, a patient specific model; providing the first information to generate a patient specific configuration…including dosage…; and presenting a configuration recommending comprising the generated patient specific configuration…including dosage…; transmitting a confirmation of the patient specific dosage…; and causing administration of the patient specific dosage for the medication by transmitting [ ] a control message including patient specific configuration; receiving…updated patient information indicating a change in the health condition of the patient during administration of the medication; generating at based at least in part on the patient specific model and the updated information, an updated patient specific model; and in response to determining that the one or more dosage parameters provided by the updated patient specific model do not fall within a predetermined threshold of corresponding parameters of the patient specific model, automatically causing [an] adjust in operation”
These claim elements are considered to be abstract ideas because they are directed to a method of mental processes, which include concepts performed in the human mind including observation, evaluation, judgment, and opinion. Receiving information about a patient and a generic model, and generating a patient specific model based on that information, and using that information make a patient specific recommendation are examples of tasks which require evaluation, judgement, observation, and opinion. An analogous example would be to provide an appropriate dose of an over the counter medication based on a patient’s age. Further, the additional parameters used in the amended limitations are also evidence of the types of information one would use to make a judgement or evaluated opinion. If a claim limitation, under broadest reasonable interpretation, covers commercial and legal interactions, then it falls within the “method of organizing human activity” grouping of abstract ideas.
Further, the modeling/generating of the model are found to be examples of a mathematical relationship/formula/calculation, and as such fall into the mathematical concepts grouping of abstract ideas.
Accordingly, the claims recite abstract idea(s).
Step 2A – Prong Two: Does the claim recite additional elements that integrate the judicial exception into a practical application? NO.
This judicial exception is not integrated into a practical application. In particular, the claim(s) recite(s) additional elements – a “medical device” and a “data storage device” are common to both claims 1, 30, with the medical device used to “administer a medication” via a “dispensing cabinet” configured to allow the dosage to be dispensed. Claim 1 is devoid of any further additional elements for consideration at this step, and claim 30 recites the use of a “a data processor” and “memory storing instructions” to perform the claim steps. The “medical device” and “data storage device” are both recited at a high-level of such that it amounts no more than mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.05(f). Data storage is generally considered insignificant extra solution activity (see MPEP 2106.05g). The “medical device” and “data storage device” both do not seem to be anything beyond a general link to the use of the judicial exception a particular technological field (see MPEP 2106.05h). Further, while the device is amended to administer a medication, this is insufficient to amount to a finding of a particular treatment for a disease or condition (see Vanda Memo) as there is neither a specific treatment for a given disease in the claims. Examiner finds that the dispensing cabinet is again merely used in the implementation of the abstract idea(s) as identified above, rather than improved upon. Similarly, the data processor and memory of claim 30 are not found to recite anything beyond a general like or an application of the computing elements to use the computer as a tool to perform the abstract idea(s). No improvement to the functioning of the computing elements or to any other technology or technical field is found (see MPEP 2106.05a). Accordingly, this/these additional element(s) do(es) not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception? NO.
The independent claim(s) is/are additionally directed to claim elements such as a “medical device” and a “data storage device” common to both claims 1, 30, with the medical device used to administer a treatment. Claim 1 is devoid of any further additional elements for consideration at this step, and claim 30 recites the use of a “a data processor” and “memory storing instructions”. When considered individually, the “medical device, data storage device, data processor, and memory storing instruction“ elements only contribute generic recitations of technical elements to the claims. It is readily apparent, for example, that the claim is not directed to any specific improvements of these elements. Examiner looks to Applicant’s specification:
[0063] The medical device 22 may be a pump or other infusion device, such as a target-controlled infusion pump, a syringe pump, an anesthesia delivery pump, and/or a patient-controlled analgesic (PCA) pump configured to deliver a medication to a patient. One or more Pk/Pd or other predictive models may be stored on the medical device 22. It should be appreciated that the medical device 22 may be any infusion device configured to deliver a substance (e.g., fluid, nutrients, medication, and/or the like) to a patient's circulatory system or epidural space via, for example, intravenous infusion, subcutaneous infusion, arterial infusion, epidural infusion, and/or the like. Alternatively, the medical device 22 may be an infusion device configured to deliver a substance (e.g., fluid, nutrients, medication, and/or the like) to a patient's digestive system via a nasogastric tube (NG), a percutaneous endoscopic gastrostomy tube (PEG), nasojejunal tube (NJ), and/or the like. Moreover, the medical device 22 may be part of a patient care system, such as the patient care system shown in FIGS. 7A-7C, which includes one or more additional pumps.
[0105] The processor 510 is capable of processing instructions for execution within the computing system 500. Such executed instructions can implement one or more components of, for example, the configuration engine 110. In some example embodiments, the processor 510 can be a single-threaded processor. Alternatively, the processor 510 can be a multi-threaded processor. The processor 510 is capable of processing instructions stored in the memory 520 and/or on the storage device 530 to present graphical information for a user interface provided via the input/output device 540.
[0106] The memory 520 is a computer readable medium such as volatile or non-volatile that stores information within the computing system 500. The memory 520 can store data structures representing configuration object databases, for example. The storage device 530 is capable of providing persistent storage for the computing system 500. The storage device 530 can be a floppy disk device, a hard disk device, an optical disk device, or a tape device, or other suitable persistent storage means.
[0123] The device 802 may be an infusion pump (e.g., the medical device 22), a dispensing cabinet (e.g., the dispensing cabinet 104), a diagnostic device (e.g., the diagnostic system 142), a smart sensor such as a Foley catheter, a laboratory system, a clinical decision support module, or other device for use in acute (e.g., hospital) or non-acute (e.g., home care, nursing home, etc.) facilities. – (i.e. dispensing cabinet is interchangeable with the medical device).
[0131] These various aspects or features can include implementation in one or more computer programs that are executable and/or interpretable on a programmable system including at least one programmable processor, which can be special or general purpose, coupled to receive data and instructions from, and to transmit data and instructions to, a storage system, at least one input device, and at least one output device.
These passages, as well as others, makes it clear that the invention is not directed to a technical improvement. When the claims are considered individually and as a whole, the additional elements noted above, appear to merely apply the abstract concept to a technical environment in a very general sense – i.e. a generic computer receives information from another generic computer, processes the information and then sends information back. The most significant elements of the claims, that is the elements that really outline the inventive elements of the claims, are set forth in the elements identified as an abstract idea. The fact that the generic computing devices are facilitating the abstract concept is not enough to confer statutory subject matter eligibility.
As per dependent claims 2-16, 18, 19, 68:
Dependent claims 2-16, 18, 19, are not directed any additional abstract ideas and are also not directed to any additional non-abstract claim elements. Rather, these claims offer further descriptive limitations of elements found in the independent claims and addressed above – such as types of interactions between the medical device and the system, various types of patient data used in the modeling, and updating the modeling and subsequent repeated steps associated with it. While these descriptive elements may provide further helpful context for the claimed invention these elements do not serve to confer subject matter eligibility to the invention since their individual and combined significance is still not heavier than the abstract concepts at the core of the claimed invention.
Dependent claim 68 recites similar non-abstract elements to exemplary claim 1 as noted above, and as such is not found to recite eligible subject matter for at least the same reasons as identified above.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-3, 8, 10-16, 18, 19, 30, 68, 69 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Condurso et al (US 20110066260 A1, hereinafter Condurso).
In reference to claim 1, 30:
Condurso teaches: A method of configuring a medical device (at least [071, 075] “patient care devices and systems 205, 210, 215 and 220 are capable of being customized through installation of data, rules and operating parameters derived from a universal configuration database containing institutionally-established guidelines for medical treatments, such as a drug dosing parameters and rules, device operating characteristics and communication parameters.”), as well as : A system comprising at least one data processor, and at least one memory storing instructions which when executed by the at least one data processor, result in operations comprising (at least [fig 1 and related text]). :
receiving first information characterizing a health condition of a patient (at least [fig 9 and related text, including 0144-0146] “A course of therapy is planned for a patient based upon patient information, such as physiology and condition, disease diagnosis …information from other hospital or institutional systems 520, information received from monitoring devices 525, which may be received directly from the monitoring devices, or retrieved from information generated by the monitoring devices, such as blood pressure, temperature, laboratory results and the like, and stored in a database accessible to the system using the communication network. Finally, patient input may also be used as a factor in generating a recommended dosing and monitoring schedule.”);
retrieving, from a model data storage device, a generic model, wherein the generic model receives, as an input, medication information for a medication, and wherein the generic model provides, as an output, a generic configuration for the medical device, and wherein the generic model automatically identified from a plurality of generic models, the identification based at least one at least one programming parameter for the medical device, the at least one programming parameter including an initial dose for the medication to be administered to the patient (at least [fig 9 and related text, including 0128-0138] “Pharmacokinetic (PK) models permit computation of the theoretical time distribution and concentration (disposition) of an infused drug within various compartments of the body including blood plasma and various "effect site" tissues. Inputs to the PK model typically include the time course of dose (Q), the drug's "parameters" obtained from controlled clinical studies and patient characteristics such as weight, age, gender, blood volume, renal clearance if available.” “…pharmacokinetic models defined by the institution to provide both initial guidance and continuing feedback to the care giver related to the delivery of medication to a patient. In a typical application, a drug is selected for delivery within a given profile for a specific patient. Pertinent patient-specific data is retrieved by the system and used to optimize the PK model for this patient. Alternatively, the system may request that the care giver enter appropriate patient information into the system to facilitate calculations using a selected PK model. There may be more than one PK model, including a plurality of PK models associated with specific drugs. Thus, in some instances, the care giver will select the appropriate PK model to use by making a selection from among a list of PK models presented to the care giver by the system….Using the selected PK model, the embodiment of the therapy management system of the present invention may provide recommendations concerning bolus and continuous dose rates needed to achieve the desired level of the drug within the patient's plasma… Further, in one embodiment of the system of the present invention, the system provides ongoing computation of compartment concentrations which are compared with institutional defined compartment limits to provide alerts, alarms and other guidance directly through the infusion system as well as via secondary communication methods such as pagers, cell phones or other hospital information systems.” At [023] “ In yet another aspect, at least one institutionally determined rule stored on the database of the system of the present invention is a pharmacokinetic model. In one alternative, the at least one institutionally determined rule is a pharmacodynamic model, while in another alternative, at least one institutionally determined rule contains information related to drug incompatibilities.” At [080, 0103, 108] starting dose, see also [0139] “For example, sodium nitroprusside may be administered to a patient experiencing acute hypertension to lower the patient's blood pressure. Sodium nitroprusside, a potent vasodilator, is typically infused by IV with an initial bolus dose followed by a continuous maintenance dose intended to rapidly achieve a specific target effect-site concentration.” – bolus dose is initial dose );
generating, based at least in part on the generic model and the health condition of the patient, a patient-specific model (at least [0137-0140] “In a typical application, a drug is selected for delivery within a given profile for a specific patient. Pertinent patient-specific data is retrieved by the system and used to optimize the PK model for this patient. Alternatively, the system may request that the care giver enter appropriate patient information into the system to facilitate calculations using a selected PK model. There may be more than one PK model, including a plurality of PK models associated with specific drugs. Thus, in some instances, the care giver will select the appropriate PK model to use by making a selection from among a list of PK models presented to the care giver by the system.”);
providing the first information to the patient-specific model to generate a patient-specific configuration for the medical device including a patient specific dosage for the medication (at least [0137-0140] “Pertinent patient-specific data is retrieved by the system and used to optimize the PK model for this patient... Using the selected PK model, the embodiment of the therapy management system of the present invention may provide recommendations concerning bolus and continuous dose rates needed to achieve the desired level of the drug within the patient's plasma… The therapy management system applies a selected PK model to evaluate the patient's data and, based upon the evaluation, make specific recommendations regarding bolus and continuous dosing amounts which are within the institution's defined limits for the delivery of nitroprusside.”) ; and
presenting a configuration recommendation, the configuration recommendation comprising the generated patient-specific configuration including the patient specific dosage for the medication (at least [0138-0140] “Using the selected PK model, the embodiment of the therapy management system of the present invention may provide recommendations concerning bolus and continuous dose rates needed to achieve the desired level of the drug within the patient's plasma.”);
transmitting, based on a confirmation of a patient specific dosage the patient specific dosage to a dispensing cabinet, the dispensing cabinet configured to allow the patient specific dosage to be dispensed (at least [070] “Additionally, for a continuous infusion, the label may include the drug name, dose, diluent (if any), drug concentration and infusion rate. Similarly, for an infusion that is to be given intermittently or as needed, the label may include the drug name, dose, diluent, concentration and administration schedule. The label is affixed to the medication container before the prescription is transported to the unit nursing station. Medications are preferably transported from the pharmacy to the nurse's station by institutional personnel, pneumatic tubes or contained within drug dispensing cabinets near the nurse's station. Alternatively, drugs may be transported using a robotic system, such as a PYXIS system (Pyxis Corporation, San Diego, Calif.). If the drug is to be distributed from a unit nursing station, then the same type of label may be printed, or hand written, at the nursing station and affixed to the drug container.”
causing the medical device to administer the patient specific dosage for the medication by transmitting to the medical device a control message including the patient specific configuration (at least [052, 0108, 0117, 0122] infusion pump 75/400 administers the medication, and the administration may be monitored remotely and/or changed based on the infusion progress; see [fig 1 and related text] CPOE system sends control to bedside control unit 55, which administers infusion pump 75);
receiving from one or more monitoring devices, updated patient information indicating a change in the health condition of the patient during the administration of the medication (at least [0139] applicability to sodium nitroprusside, at [0140] “ The patient's blood pressure may be continuously monitored using, for example, a monitoring device designed to monitor blood pressure in the patient's radial artery. Samples of the patient's blood, urine and other fluids or tissues may be drawn to evaluate the patient's hematology and renal function.” (At least [0113] “…the various modules of the therapy management system tracks the administration of therapy to a patient, including the results of various laboratory tests performed on the patient or the patient's blood. This data may also be integrated with information received from various clinical devices that are monitoring the patient's vital signs, such as blood pressure, EtCO.sub.2 or SpO.sub.2. Applying rules and guidelines stored in a database of information reflecting acceptable levels and good practices of the institution, the programs of the therapy management system of the present invention may analyze the data and identify when a prescribed therapy is achieving a desired result, and may also identify when the desired results are not being achieved, indicating that adjustments to the therapy being delivered to the patient require adjustment.”);
generating based at least in part on the patient specific model and the updated information, an updated patient specific model (at least [0139-0143] “Referring again to the example of sodium nitroprusside infusion, a suitably programmed embodiment of the present invention may access and retrieve stored data representing sequential measurements of arterial blood pressure for a specific patient and compute the effect-site drug concentration. The system is programmed to evaluate this data and calculate a pharmacodynamic concentration-response curve for the patient. From this response curve, the patient's sensitivity to changes in effect-site concentration may be determined from the rate of change of the response to the effect site concentration. The patient's response sensitivity, in turn, may be used by the system to generate recommendations related to adjusting the dosing therapy to achieve a specific clinical target such as a reduced blood pressure level. For example, an estimate of the relation between blood pressure and effect site concentration of nitroprusside by the system would inform the care giver of how much to increase or decrease dosage in order to achieve the desired endpoint. Further, in another embodiment, the system may provide the care giver with specific recommendations for modifying the dosing protocol to achieve the desired effect.”); and
in response to determining that one or more dosage parameters provided by the updated patient-specific model do not fall within a predetermined threshold of corresponding parameters of the patient specific model, automatically causing the medical device to adjust operation (at least [0141] “ Later, when appropriate laboratory testing results, such as results for renal function, for the patient are entered into the system and become available, the system evaluates this data to determine the appropriateness of the initial limits used to determine the recommended delivery parameters. For example, if the laboratory test results indicate that renal clearance is limited, the upper dosing limit for delivery of the nitroprusside to the specific patient may need to be readjusted. Additionally, the effect-site concentration limit may be lowered as a function of the sub-optimal renal clearance to avoid buildup of toxic metabolic by products of the nitroprusside.” [014] “For example, the rule for maximum and minimum dose of a vasoactive drug such as sodium nitroprusside can be made dependent on the arterial blood pressure measured by a separate instrument. If the mean blood pressure exceeds a predetermined limit or meets a certain categorization such as "high", then the dosing parameter defining the upper continuous dose limit would be reduced in accordance with the parameters of the dosing rule for that drug within a selected behavior descriptor, as that term will be defined below.”)
In reference to claim 2:
Condurso further teaches: identifying the medical device associated with the patient (at least [fig 1 and related text, including 052] controller 55 as it pertains to patient devices); and
transmitting, to the medical device associated with the patient, a control message including the patient-specific configuration (at least [052-053] “Bedside controller 55 communicates with other institutional systems using communication system 50. In one embodiment, controller 55 sends information to and receives information and/or operational commands or parameters from server 60. Server 60 includes various modules such as a rules database and engine 90, event reporting module 95, a module for tracking clinical device location and status 100, and other modules 105, such as a reporting module that may generate either standardized reports for use within the institution, or which may be programmed by input from care givers, technicians, or other institutional personnel to provide customized reports.”).
In reference to claim 3:
Condurso further teaches: wherein the patient-specific configuration is different from the generic configuration (at least [0137-0140] “pharmacokinetic models defined by the institution to provide both initial guidance and continuing feedback to the care giver related to the delivery of medication to a patient. In a typical application, a drug is selected for delivery within a given profile for a specific patient. Pertinent patient-specific data is retrieved by the system and used to optimize the PK model for this patient…” see example in [0139-0140]).
In reference to claim 8:
Condurso further teaches:
receiving second information characterizing a second health condition of the patient at a second time that is after a first time of the first health condition (at least [0113-117] “the various modules of the therapy management system tracks the administration of therapy to a patient, including the results of various laboratory tests performed on the patient or the patient's blood. This data may also be integrated with information received from various clinical devices that are monitoring the patient's vital signs, such as blood pressure, EtCO.sub.2 or SpO.sub.2.” see also [052, 066, 086] for monitoring of existing health conditions; see 0144 for monitoring example);
generating, based at least in part on the patient-specific model and the second information, an updated patient-specific model (at least [0113-0117, 0144-0145] using the modeling technique in 0128-0141, models are continuously updated); and
providing the second information to the updated patient-specific model to generate an updated patient-specific configuration for the medical device (at least [0113-0117, 0144-0145] “Applying rules and guidelines stored in a database of information reflecting acceptable levels and good practices of the institution, the programs of the therapy management system of the present invention may analyze the data and identify when a prescribed therapy is achieving a desired result, and may also identify when the desired results are not being achieved, indicating that adjustments to the therapy being delivered to the patient require adjustment. In another embodiment, the therapy management system may analyze the various patient related data from the laboratory system, vital signs monitoring devices and therapy administration devices and by applying rules and guidelines stored in a rules database to the analyzed information and suggest alternative courses of treatment, or adjustment of current treatment parameters, to achieve a desired result.” See also [0122-127] for discussion of second medication interactions).
In reference to claim 10
Condurso further teaches: generating an alert indicating that an updated patient-specific configuration has been generated (at least [0105-6, 0138, 0144] “the system provides ongoing computation of compartment concentrations which are compared with institutional defined compartment limits to provide alerts, alarms and other guidance directly through the infusion system as well as via secondary communication methods such as pagers, cell phones or other hospital information systems.”).
In reference to claim 11:
Condurso further teaches: determining that the second health condition is different from the first health condition (at least [0113-0117, 0122-0127] vital signs are monitored, an updated issue with a vital sign is a distinct condition and/or in consideration of a second medication needing to be dosed; see further [052, 066, 086] for monitoring of existing health conditions; see 0144 for monitoring example.).
In reference to claim 12:
Condurso further teaches: generating an alert indicating that the patient-specific configuration should be updated. (at least [0105-6, 0138, 0144] “the system provides ongoing computation of compartment concentrations which are compared with institutional defined compartment limits to provide alerts, alarms and other guidance directly through the infusion system as well as via secondary communication methods such as pagers, cell phones or other hospital information systems.” “If the system determines the parameters are not appropriate, the system may alert the care giver, and, in some embodiments, provide the care giver with recommendations for adjusting the delivery parameters of the drugs to ensure that delivery of the drugs is performed as set forth by the institutionally determined rules. Moreover, the system, applying the PD model in accordance with clinical and laboratory results, as well as pertinent patient information, may dynamically adjust the defined dose and compartment concentration limits.”).
In reference to claim 13:
Condurso further teaches: causing a change in operation of the medical device (at least [0144] “If the system determines the parameters are not appropriate, the system may alert the care giver, and, in some embodiments, provide the care giver with recommendations for adjusting the delivery parameters of the drugs to ensure that delivery of the drugs is performed as set forth by the institutionally determined rules. Moreover, the system, applying the PD model in accordance with clinical and laboratory results, as well as pertinent patient information, may dynamically adjust the defined dose and compartment concentration limits.”).
In reference to claim 14:
Condurso further teaches: causing the medical device to stop operation according to the patient-specific configuration (at least [021] “server also communicates a command to the processor of the medication delivery device to stop delivery of the medication.”).
In reference to claim 15:
Condurso further teaches: causing the medical device to operate according to the updated patient-specific configuration (at least [0144] “If the system determines the parameters are not appropriate, the system may alert the care giver, and, in some embodiments, provide the care giver with recommendations for adjusting the delivery parameters of the drugs to ensure that delivery of the drugs is performed as set forth by the institutionally determined rules. Moreover, the system, applying the PD model in accordance with clinical and laboratory results, as well as pertinent patient information, may dynamically adjust the defined dose and compartment concentration limits.”).
In reference to claim 16:
Condurso further teaches: wherein the first information comprises patient data, the patient data representing one or more of a genetic test result, a genomic test result, a change in organ function of the patient, a severity of illness of the patient, a type of health condition of the patient, an allergy of the patient, a medication prescribed for the patient, a liver function test result, a kidney function test result, a molecular test result, a drug level test result, and a blood cell panel (at least [0113] “…various modules of the therapy management system tracks the administration of therapy to a patient, including the results of various laboratory tests performed on the patient or the patient's blood. This data may also be integrated with information received from various clinical devices that are monitoring the patient's vital signs, such as blood pressure, EtCO.sub.2 or SpO.sub.2.” at [0129] “patient characteristics such as weight, age, gender, blood volume, renal clearance if available.” At [0146] “…information about the patient's age, weight, gender, allergies and other conditions and the like may be used by the system to develop an appropriate dosing and monitoring schedule. Additionally, information from the patient regarding the patient's assessment of his or her condition, such as a patient's rating of pain he or she is experiencing, may also be inputted into the system.”).
In reference to claim 18:
Condurso further teaches: wherein the patient-specific model is further generated based at least in part on whether the health condition of the patient is improving or worsening (at least [0113] “Applying rules and guidelines stored in a database of information reflecting acceptable levels and good practices of the institution, the programs of the therapy management system of the present invention may analyze the data and identify when a prescribed therapy is achieving a desired result, and may also identify when the desired results are not being achieved, indicating that adjustments to the therapy being delivered to the patient require adjustment.”).
In reference to claim 19:
Condurso further teaches: wherein the patient-specific model is further generated based at least in part on medical device data, the medical device data comprising one or more medication-specific or diagnostic-specific information (at least [0128-0141] “When the patient is admitted to the institution, the patient's age, weight, gender and other specific data are entered into the institution's information system and thus may be accessed and retrieved by the therapy management system of the present invention. The patient's blood pressure may be continuously monitored using, for example, a monitoring device designed to monitor blood pressure in the patient's radial artery. Samples of the patient's blood, urine and other fluids or tissues may be drawn to evaluate the patient's hematology and renal function. All of this information may be stored in one or more databases resident on the institutions information.”).
In reference to claim 68:
Condurso further teaches wherein the at least one programming parameter for the medical device upon which the identification of the generic model is based includes a care area, or use of the medical device (at least [fig 9 and related text, including 0128-0138] “…pharmacokinetic models defined by the institution to provide both initial guidance and continuing feedback to the care giver related to the delivery of medication to a patient. In a typical application, a drug is selected for delivery within a given profile for a specific patient. Pertinent patient-specific data is retrieved by the system and used to optimize the PK model for this patient. Alternatively, the system may request that the care giver enter appropriate patient information into the system to facilitate calculations using a selected PK model. There may be more than one PK model, including a plurality of PK models associated with specific drugs. Thus, in some instances, the care giver will select the appropriate PK model to use by making a selection from among a list of PK models presented to the care giver by the system … Further, in one embodiment of the system of the present invention, the system provides ongoing computation of compartment concentrations which are compared with institutional defined compartment limits to provide alerts, alarms and other guidance directly through the infusion system as well as via secondary communication methods such as pagers, cell phones or other hospital information systems.” At [0023] “ In yet another aspect, at least one institutionally determined rule stored on the database of the system of the present invention is a pharmacokinetic model. In one alternative, the at least one institutionally determined rule is a pharmacodynamic model, while in another alternative, at least one institutionally determined rule contains information related to drug incompatibilities.” – i.e. institution rules/area of care).
In reference to claim 69:
Condurso further teaches wherein automatically causing the medical device to adjust operation comprises one or more of disabling power to a hardware element of the medical device, causing the medical device to stop administration of the medication, or causing the medical device to operate according to an updated patient-specific configuration (at least [0139] applicability to sodium nitroprusside, at [0140] “ The patient's blood pressure may be continuously monitored using, for example, a monitoring device designed to monitor blood pressure in the patient's radial artery. Samples of the patient's blood, urine and other fluids or tissues may be drawn to evaluate the patient's hematology and renal function.” (At least [0113] “…the various modules of the therapy management system tracks the administration of therapy to a patient, including the results of various laboratory tests performed on the patient or the patient's blood. This data may also be integrated with information received from various clinical devices that are monitoring the patient's vital signs, such as blood pressure, EtCO.sub.2 or SpO.sub.2. Applying rules and guidelines stored in a database of information reflecting acceptable levels and good practices of the institution, the programs of the therapy management system of the present invention may analyze the data and identify when a prescribed therapy is achieving a desired result, and may also identify when the desired results are not being achieved, indicating that adjustments to the therapy being delivered to the patient require adjustment.”).
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) 4-7, 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Condurso in view of White et al (US 6790198 B1, hereinafter White).
In reference to claim 4:
Condurso as cited teaches all the limitations above, however, while Condurso does teach a confirmation or alert, as well as badge/medication scanning, in the interest of compact prosecution Examiner notes it does not specifically disclose requesting a confirmation. White however does teach: requesting confirmation that the generated patient-specific configuration should be transmitted to the medical device (at least [fig 5 and related text] “… a nurse brings up a patient's medication administration record (MAR) on the hand-held unit 98 at step 69. The nurse then confirms that the infusion data and IV pump operating characteristics are appropriate for the MAR information for the identified patient at step 71. Where the characteristics are appropriate, data is communicated to the HIMS at step 73 and the nurse activates the read-wireless data menu on the IV pump at step 75. With the read-wireless data menu item activated, the infusion data and characteristics are transmitted to the pump via wireless signal, according to step 77 in FIG. 5. With the infusion pump characteristics thus entered wirelessly into the infusion pump, the nurse may validate that the data received by the IV pump is correct. This may be done by observing the pump display 40. Upon validating the accuracy of the entry, the beginning of infusion may be authorized at step 79.”). Condurso and White are analogous as both disclose similar means of monitoring patient specific treatments. One of ordinary skill in the art would have found the confirmation request of White to be an obvious addition to the multiple checks and balances for dosing as taught by Condurso, particularly in view of the emphasis placed on responding to alerts in Condurso. Further, White teaches the interactive approval request allows for an additional checkpoint, thereby ensuring patient safety and medical professional compliance with the individual dosing for a given patient, and that the request for confirmation can ensure all providers are on the same page (see Col 2).
In reference to claim 5:
Condurso/White teaches all the limitations above. White further teaches: receiving, in response to the requested confirmation, the confirmation (at least [fig 5 and related text] “In this method, a nurse brings up a patient's medication administration record (MAR) on the hand-held unit 98 at step 69. The nurse then confirms that the infusion data and IV pump operating characteristics are appropriate for the MAR information for the identified patient at step 71. Where the characteristics are appropriate, data is communicated to the HIMS at step 73 and the nurse activates the read-wireless data menu on the IV pump at step 75. With the read-wireless data menu item activated, the infusion data and characteristics are transmitted to the pump via wireless signal, according to step 77 in FIG. 5. With the infusion pump characteristics thus entered wirelessly into the infusion pump, the nurse may validate that the data received by the IV pump is correct. This may be done by observing the pump display 40. Upon validating the accuracy of the entry, the beginning of infusion may be authorized at step 79.”) Condurso and White are analogous as both disclose similar means of monitoring patient specific treatments. One of ordinary skill in the art would have found the confirmation request of White to be an obvious addition to the multiple checks and balances for dosing as taught by Condurso, particularly in view of the emphasis placed on responding to alerts in Condurso. Further, White teaches the interactive approval request allows for an additional checkpoint, thereby ensuring patient safety and medical professional compliance with the individual dosing for a given patient, and that the request for confirmation can ensure all providers are on the same page (see Col 2).
In reference to claim 6:
Condurso/White teaches all the limitations above. White further teaches: receiving in response to the requested confirmation, an adjustment of the patient specific configuration (at least [fig 5, 6A] nurse validates the data, if the data is not validated the nurse may correct or enter into manual mode). Condurso and White are analogous as both disclose similar means of monitoring patient specific treatments. One of ordinary skill in the art would have found the confirmation request of White to be an obvious addition to the multiple checks and balances for dosing as taught by Condurso, particularly in view of the emphasis placed on responding to alerts in Condurso. Further, White teaches the interactive approval request allows for an additional checkpoint, thereby ensuring patient safety and medical professional compliance with the individual dosing for a given patient, and that the request for confirmation can ensure all providers are on the same page (see Col 2).
In reference to claim 7:
Condurso further teaches: generating the patient-specific configuration for the medical device (at least [0137-0141] patient information used to create a patient specific dosing using the medical device(s)/infusion pumps, see also [052] for discussion of devices).
In reference to claim 9:
Condurso as cited teaches all the limitations above, however, while Condurso does teach a confirmation or alert, as well as an updated patient specific configuration (at least [0113-0117, 0144-0145]), as well as badge/medication scanning, in the interest of compact prosecution Examiner notes it does not specifically disclose requesting a confirmation. White however does teach: requesting confirmation that the generated patient-specific configuration should be transmitted to the medical device (at least [fig 5 and related text] “… a nurse brings up a patient's medication administration record (MAR) on the hand-held unit 98 at step 69. The nurse then confirms that the infusion data and IV pump operating characteristics are appropriate for the MAR information for the identified patient at step 71. Where the characteristics are appropriate, data is communicated to the HIMS at step 73 and the nurse activates the read-wireless data menu on the IV pump at step 75. With the read-wireless data menu item activated, the infusion data and characteristics are transmitted to the pump via wireless signal, according to step 77 in FIG. 5. With the infusion pump characteristics thus entered wirelessly into the infusion pump, the nurse may validate that the data received by the IV pump is correct. This may be done by observing the pump display 40. Upon validating the accuracy of the entry, the beginning of infusion may be authorized at step 79.”). Condurso and White are analogous as both disclose similar means of monitoring patient specific treatments. One of ordinary skill in the art would have found the confirmation request of White to be an obvious addition to the multiple checks and balances for dosing as taught by Condurso, particularly in view of the emphasis placed on responding to alerts in Condurso. Further, White teaches the interactive approval request allows for an additional checkpoint, thereby ensuring patient safety and medical professional compliance with the individual dosing for a given patient, and that the request for confirmation can ensure all providers are on the same page (see Col 2).
Response to Arguments
Applicant’s remarks as filed on 31 MARCH 2026 have been fully considered.
Applicant begins with a discussion of the 101 rejection on page 7, with a reproduction of exemplary claim 1. Applicant makes reference to Ex Parte Desjardins on page 8, and asserts an improvement is present. Examiner respectfully disagrees with Applicant’s characterization of an improvement to a computer/technology – instead, Applicant’s remarks and cited portions of the specification are found to recite an improvement to patient dosing, rather than controlling a medical device. Patient conditions change regardless of the device, and such consequences arise based on the dosing, rather than the controlling of a medical device as alleged.
Applicant turns to a discussion of a practical application on page 9. Again, Applicant’s citations and discussions appear to recite an improvement it patient dosing – this is not an inherently technical problem as per the analysis/MPEP. Providing correct dosing is of course important, given how for example insulin can require routine updates to doses, however, the dosing calculations are not a technical problem being improved. Examiner does not disagree that Applicant’s claims recite the improvement, instead, Examiner finds that, as stated, the improvement itself is not technical. Applicant is apparently arguing an abstract idea not being present at the bottom of page 9, however, it is unclear how this pertains to the improvement asserted. As per Applicant’s newly amended limitations, the discussion on page 9 is found to be unpersuasive. A control message is not itself administering the medical device. Applicant is not claiming a medical device so much as controlling one. Telling someone to administer a dose of medication is not the same as actually administering the medication itself. Determining a relationship to a threshold is similarly, not the same as actually acting upon. Applicant’s remarks regarding the disabling of power to a medical device are noted, however, Examiner notes that these limitations are recited in the alternative and as such the claim may actually only require operating according to an updated configuration.
Applicant’s remarks regarding the prior art rejection being on page 11 with a recitation of exemplary independent claim 1. In view of the above updated rejection, Examiner respectfully disagrees with Applicant’s statement that the reference does not teach the newly amended limitations. Examiner notes Claim 69 recites the three options in the alternative.
Applicant’s remarks regarding the 103 rejection on page 12 are noted, Examiner respectfully disagrees as White is not cited to these limitations.
Relevant Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 2020/0245925 to Inwald, which discloses patient specific dosing for medication.
US 2018/0218782, to Spotts discloses monitoring dosing to a given patient and adjusting as needed.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE KOLOSOWSKI-GAGER whose telephone number is (571)270-5920. The examiner can normally be reached Monday - Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mamon Obeid can be reached at 571-270-1813. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHERINE . KOLOSOWSKI-GAGER/
Primary Examiner
Art Unit 3687
/KATHERINE KOLOSOWSKI-GAGER/Primary Examiner, Art Unit 3687
Prosecution Insights