Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
Claims 1-2, 5-10, 13-17, and 20 are currently pending. Claims 3-4, 11-12, and 18-19 are canceled in the Claims filed on February 18, 2026. Claims 17 and 20 were withdrawn in the Claims filed on August 18, 2025.
Information Disclosure Statement
The information disclosure statement submitted on March 3, 2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by Examiner.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-2, 5-6, 9-10, and 13-14 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Step 1
Claims 1-2, 5-6, 9-10, and 13-14 are within the four statutory categories. Claims 1-2 and 5-6 are drawn to a device for managing data pertaining to an infusion operation, which is within the four statutory categories (i.e. machine). Claims 9-10 and 13-14 are drawn to a method for managing data pertaining to an infusion operation, which is within the four statutory categories (i.e. process).
Prong 1 of Step 2A
Claim 1, which is representative of the inventive concept, recites: An infusion device, the infusion device comprising:
a pump;
a display screen; and
a control unit configured by instructions that, when executed by a processor, cause the control unit to:
provide, using the pump, an intravenous infusion of a first medication to a current patient;
display on the display screen, while the infusion is being provided by the pump, a representation of a status of the intravenous infusion;
send, during the infusion, to a remote records system, infusion information including a patient identifier and order identifier for the infusion currently being provided by the pump;
receive, from the remote records system, a confirmation of the infusion information including association information representative of an association between: (a) the infusion of the first medication, (b) the current patient, and (c) the pump;
receive, at the infusion device, an indication of a change to the infusion currently being provided by the pump including changing from the first medication to a new medication;
compare the change with the association information received from the remote records system;
determine, based on comparing the change with the association information received from the remote records system, that a record for the current patient stored at the remote records system has not been updated with an order for the new medication;
update the representation of the status displayed on the display screen to indicate that the association information received from the remote records system no longer applies to the intravenous infusion;
send a message to the remote records system indicating that the infusion device has determined that the association information no longer applies to the changed infusion; and
causing the remote records system to stop recording infusion data pertaining to the first medication and to start recording infusion data pertaining to the new medication.
The underlined limitations as shown above, given the broadest reasonable interpretation, cover the abstract idea of a certain method of organizing human activity because they recite managing personal behavior or relationships or interactions between people (i.e. social activities, teaching, and following rules or instructions – in this case, the steps of displaying the status of the infusion, sending infusion information, receiving a confirmation of the infusion information including association information between the infusion and the current patient or pump, receiving an indication of a change to the infusion, comparing the change with the association information, determining that the change has not yet been reflected in the patient record, updating the representation of the status to indicate that the association no longer applies, sending a message indicating that the association no longer applies, and stopping the recording of infusion data for the first medication and starting the recording of infusion data for the new medication recite following rules or instructions for managing the conveying of information related to an infusion operation), e.g. see MPEP 2106.04(a)(2). Any limitations not identified above as part of the abstract idea are deemed “additional elements,” and will be discussed in further detail below.
Furthermore, the abstract idea for Claim 9 is identical as the abstract idea for Claim 1, because the only difference between Claims 1 and 9 is that Claim 1 recites a device, whereas Claim 9 recites a method.
Dependent Claims 2, 5-6, 10, and 13-14 include other limitations, for example Claims 2 and 10 recite a type of representation of the status, Claims 5 and 13 recite buffering data until the changed infusion is configured, creating an association between the changed infusion and the current patient, and beginning recording data for the changed infusion, and Claims 6 and 14 recite changing a current patient to a new patient and disassociating the current patient from the infusion device, but these only serve to further narrow the abstract idea, and a claim may not preempt abstract ideas, even if the judicial exception is narrow, e.g. see MPEP 2106.04, and/or do not further narrow the abstract idea and instead only recite additional elements, which will be further addressed below. Hence dependent Claims 2, 5-6, 10, and 13-14 are nonetheless directed towards fundamentally the same abstract idea as independent Claims 1 and 9.
Hence Claims 1-2, 5-6, 9-10, and 13-14 are directed towards the aforementioned abstract idea.
Prong 2 of Step 2A
Claims 1 and 9 are not integrated into a practical application because the additional elements (i.e. the non-underlined limitations above – in this case, the providing of the intravenous infusion to the patient, and the hardware limitations of the pump, the control unit, the processor, the display screen, and the remote records system) amount to no more than limitations which:
amount to mere instructions to apply an exception – for example, the recitation of the control unit, the processor, the display screen, and the remote records system, which amounts to merely invoking a computer as a tool to perform the abstract idea, e.g. see [0045]-[0046] and [0051] of the as-filed Specification, and see MPEP 2106.05(f);
generally link the abstract idea to a particular technological environment or field of use – for example, the claim language of the pump, which amounts to limiting the abstract idea to the field of medication infusion, e.g. see MPEP 2106.05(h); and/or
add insignificant extra-solution activity to the abstract idea – for example, the recitation of providing the intravenous infusion of the medication, and performing various operations while the infusion is occurring, which amounts to an insignificant application, e.g. see MPEP 2106.05(g).
Additionally, dependent Claims 2, 5-6, 10, and 13-14 include other limitations, but these limitations also amount to generally linking the abstract idea to a particular technological environment or field of use (e.g. the particular types of data recited in dependent Claims 5-6 and 13-14), and/or do not include any additional elements beyond those already recited in independent Claims 1 and 9, and hence also do not integrate the aforementioned abstract idea into a practical application.
Hence Claims 1-2, 5-6, 9-10, and 13-14 do not include additional elements that integrate the judicial exception into a practical application.
Step 2B
Claims 1 and 9 do not include additional elements that are sufficient to amount to “significantly more” than the judicial exception because the additional elements (i.e. the non-underlined limitations above – in this case, the providing of the intravenous infusion to the patient, and the hardware limitations of the pump, the control unit, the processor, the display screen, and the remote records system), as stated above, are directed towards no more than limitations that amount to mere instructions to apply the exception, generally link the abstract idea to a particular technological environment or field of use, and/or add insignificant extra-solution activity to the abstract idea, wherein the additional elements comprise limitations which:
amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields, as demonstrated by:
The present Specification expressly disclosing that the structural additional elements are well-understood, routine, and conventional in nature:
[0045]-[0046] and [0051] of the as-filed Specification discloses that the additional elements (i.e. the control unit, the processor, the display screen, and the remote records system) comprise a plurality of different types of generic computing systems;
Relevant court decisions: The functional limitations interpreted as additional elements are analogized to the following examples of court decisions demonstrating well-understood, routine and conventional activities, e.g. see MPEP 2106.05(d)(II):
Receiving or transmitting data over a network, e.g. see Intellectual Ventures v. Symantec – similarly, the additional elements recite sending/receiving infusion and confirmation data over a network to/from the remote records system and the infusion device, e.g. see [0087] of the as-filed Specification;
Electronic recordkeeping, e.g. see Alice Corp v. CLS Bank – similarly, the additional elements merely recite the creating and maintaining of infusion information at the remote records system, and stopping and starting the recording of infusion information based on the medication being infused;
Storing and retrieving information in memory, e.g. see Versata Dev. Group, Inc. v. SAP Am., Inc. – similarly, the additional elements recite storing infusion information in the remote records system, and retrieving the infusion information in order to perform the comparison, the updating of the representation of the status, and the sending of the message;
Cutting hair after first determining the hair style, e.g. see In re Brown – similarly, the additional elements merely recite providing the intravenous infusion of the medication at a high level of generality;
Dependent Claims 2, 5-6, 10, and 13-14 include other limitations, but none of these limitations are deemed significantly more than the abstract idea because the additional elements recited in the aforementioned dependent claims similarly amount to generally linking the abstract idea to a particular technological environment or field of use (e.g. the particular types of data recited in dependent Claims 3-6 and 11-14), and/or the limitations recited by the dependent claims do not recite any additional elements not already recited in independent Claims 1 and 9, and hence do not amount to “significantly more” than the abstract idea.
Hence, Claims 1-2, 5-6, 9-10, and 13-14 do not include any additional elements that amount to “significantly more” than the judicial exception.
Thus, taken alone, the additional elements do not amount to significantly more than the abstract idea identified above. Furthermore, looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually, and there is no indication that the combination of elements improves the functioning of a computer or improves any other technology, and their collective functions merely provide conventional computer implementation.
Therefore, whether taken individually or as an ordered combination, Claims 1-2, 5-6, 9-10, and 13-14 are nonetheless rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Examiner further notes that Claims 7-8 and 15-16 are not rejected under 35 U.S.C. because they recite “adjusting infusion parameters on the infusion device to implement the change to the infusion when the confirmation is received,” “terminating the infusion when the confirmation is not received,” “determining a second infusion being provided,” and “terminating the second infusion” when the confirmation is not received. The aforementioned limitations are interpreted as additional elements that integrate the abstract idea into a practical application because they recite the application of the judicial exception by or with a particular machine, e.g. see MPEP 2106.05(b). The limitations of Claims 7-8 and 15-16 recite a particular machine (i.e. the infusion device) that physically implements the steps of the method to change the infusion parameters (i.e. the infusion device receives the adjusted infusion parameters and confirmation, and implements the change to infusion when confirmation is received, and in the case where confirmation is not received, terminates the infusion). This is in contrast to the recitations of independent Claims 1 and 9, which merely recite that the infusion device provides an intravenous infusion of a medication irrespective of any preceding determinations, and wherein the infusion operation is further not affected by any subsequent determinations, and hence the infusion operation recited in Claims 1 and 9 are, as shown above, reasonably interpreted as an insignificant extra-solution activity. For the aforementioned reasons, Claims 7-8 and 15-16 are not rejected under 35 U.S.C. 101.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 6, 9, and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mihai (US 2004/0167465) in view of Heavelyn (US 2019/0348160), further in view of Guerra (US 2020/0230316).
Regarding Claim 1, Mihai teaches the following: An infusion device, the infusion device comprising:
a pump (The system includes a medical device comprising an infusion pump, e.g. see Mihai [0090].);
a display screen (The infusion pump includes a display, e.g. see Mihai [0205].); and
a control unit configured by instructions that, when executed by a processor (The medical device is controlled by a processor, e.g. see Mihai [0177].), cause the control unit to:
provide, using the pump, an intravenous infusion of a medication to a current patient (The system begins infusion of a medication to a patient, e.g. see Mihai [0301]-[0302].);
display on a display screen, while the infusion is being provided by the pump, a representation of a status of the intravenous infusion (The system displays infusion information on an electronic computing device and the pump, e.g. see Mihai [0179].);
send, during the infusion, to a remote records system, infusion information including a patient identifier and order identifier for the infusion currently being provided by the pump (The system periodically transmits infusion information for each infusion device to a hub or a first/second central computer or server system, e.g. see Mihai [0090] and [0109], wherein the hub enables a clinician to view the infusion status information on a clinician digital assistant, e.g. see Mihai [0091]. Furthermore, the clinician may view the infusion status information after the infusion pump has initiated a therapy (i.e. during the infusion), wherein the infusion status information includes a patient identification and identification information for the medication of the therapy, e.g. see Mihai [0396], Fig. 43.);
receive, at the infusion device, an indication of a change to the infusion currently being provided by the pump (The system enables a user to modify an existing infusion order via a clinician digital assistant or the pump, e.g. see Mihai [0241], wherein a change may include changing the channel of a pump when the infusion associated with the patient was listed in a second central server database, e.g. see Mihai [0438] and [0473].);
compare the change with association information received from the remote records system (The system transmits a “change pump channel” action (i.e. the change) to a second central server, which, upon determining that the “change pump channel” action is valid, generates a “change pump channel” XML document (i.e. association information) that is sent to the first central server, wherein the first central server verifies that the XML document is valid, e.g. see Mihai [0474]-[0479].);
determine, based on comparing the change with the association information received from the remote records system, that a record for the current patient stored at the remote records system has not been updated (The first central server determines whether the “change pump channel” XML document is valid, and when it is valid, displays a series of prompts for the user enabling the changing of the pump channel, e.g. see Mihai [0477]-[0479], wherein the system includes documentation that tracks data for every step in the infusion administration process including infusion order information and changes in real-time, e.g. see Mihai [0326] and [0328]-[0329]. That is, the system determines when a change has occurred, verifies that the change is valid (i.e. the record has not been updated), and then updates the documentation to reflect the change.);
update the representation of the status displayed on the display screen to indicate that the association information received from the remote records system no longer applies to the intravenous infusion (The system displays a series of prompts, for example a “continue” button and a “cancel” button, that enable the user to proceed with the changing of the pump channel, e.g. see Mihai [0479]-[0484].); and
send a message to the remote records system indicating that the infusion device has determined that the association information no longer applies to the changed infusion (The system transmits a record to the first central server indicating that the change of the pump channel was successful, e.g. see Mihai [0484].).
But Mihai does not teach and Heavelyn teaches the following:
receive, from the remote records system, a confirmation of the infusion information including association information representative of an association between: (a) the infusion of the first medication, (b) the current patient, and (c) the pump (The system generates an order (i.e. association information) for a pump including a pump identifier, a patient identifier, and medication information including a volume to be infused, e.g. see Heavelyn [0101]-[0102].);
Furthermore, before the effective filing date, it would have been obvious to one ordinarily skilled in the art of healthcare to modify Mihai to incorporate automatically associating the pump, the patient, and the medication with each other as taught by Heavelyn in order to reduce the time and burden required for patient documentation, e.g. see Heavelyn [0005] and [0043].
But the combination of Mihai and Heavelyn does not teach and Guerra teaches the following:
wherein the change includes changing from the first medication to a new medication (The system comprises an infusion pump to deliver medication to a patient, e.g. see Guerra [0031], wherein the infusion pump may include a first and second syringe including different medications, e.g. see Guerra [0032], wherein the first syringe may be replaced by (i.e. changed to) the second syringe, e.g. see Guerra [0036] and [0042]. Additionally, the system may include a plurality of pumps, with each pump representing a pump channel, e.g. see Guerra [0070].);
wherein the update includes an order for a new medication (The system includes a tracking engine that tracks the volumes of medications delivered to the patient, including the volumes for the first medication and the second (i.e. new) medication, e.g. see Guerra [0033], and further includes a dose counter that updates based on the medications delivered to the patient, e.g. see Guerra [0038]-[0039].); and
causing the remote records system to stop recording infusion data pertaining to the first medication and to start recording infusion data pertaining to the new medication (The system determines when the second syringe contains a second medication rather than additional volume of a first medication, and tracks the volume of the second medication dispensed rather than continuing to track the volume of the first medication, e.g. see Guerra [0036], and [0039]-[0043].).
Furthermore, before the effective filing date, it would have been obvious to one ordinarily skilled in the art of healthcare to modify the combination of Mihai and Heavelyn to incorporate the new medication and tracking the dispensing of the new medication as taught by Guerra in order to make it easier to track multiple medications and reduce and/or eliminate opportunities for abuse or diversion, e.g. see Guerra [0029].
Regarding Claim 6, the combination of Mihai, Heavelyn, and Guerra teaches the limitations of Claim 1, and Mihai further teaches the following:
The infusion device of Claim 1, wherein the change to the infusion currently being provided by the infusion device comprises changing the current patient to a new patient (The operations performed by the infusion pump include scanning a pump channel, e.g. see Mihai [0438], wherein scanning the pump channel includes scanning for a valid channel identifier and for a valid patient identifier, wherein if a scanned or entered patient identifier does not match a patient identifier in a database (i.e. the scanned or entered patient identifier is for a new patient), the system presents various messages to the user, for example indicating that a different patient is associated with the channel but that the different patient may be overwritten, e.g. see Mihai [0465]-[0467].), and wherein determining that the association information received from the remote records system no longer applies to the changed infusion comprises determining, by the control unit of the infusion device, that the infusion device has not been assigned to the new patient at the remote records system (The system determines that the scanned patient identifier does not match the patient identifier in the database (i.e. the infusion device has not been assigned to the new patient at the remote records system), and may enable a user to overwrite the existing data to remove the association with the previous patient and associate the new patient with the device, e.g. see Mihai [0465]-[0467].), and
wherein sending the message to the remote records system comprises:
instructing the remote records system to disassociate the current patient from the infusion device (The system determines that the scanned patient identifier does not match the patient identifier in the database, and may enable a user to overwrite the existing data to remove the association with the previous patient and associate the new patient with the device, e.g. see Mihai [0465]-[0467].).
Regarding Claims 9 and 14, the limitations of Claims 9 and 14 are substantially similar to those claimed in Claims 1 and 6, with the sole difference being that Claims 1 and 6 recite a device, whereas Claims 9 and 14 recite a method. Specifically pertaining to Claims 9 and 14, Examiner notes that Mihai teaches that the invention may be embodied as methods an apparatuses, e.g. see Mihai [0004]-[0005], and hence the grounds of rejection provided above for Claims 1 and 6 are similarly applied to Claims 9 and 14.
Claims 2 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Mihai, Heavelyn, and Guerra in view of Hickle (US 2003/0135087).
Regarding Claim 2, the combination of Mihai, Heavelyn, and Guerra teaches the limitations of Claim 1, but does not teach and Hickle teaches the following:
The infusion device of Claim 1, wherein the representation of the status comprises a single colored light, and wherein updating the representation comprises changing a color of the single colored light from a first color to a second color (The system includes an LED that lights a particular color based on the status of infusion device, for example changing the status of a medication cassette changes the color of the light, e.g. see Hickle [0069].).
Furthermore, before the effective filing date, it would have been obvious to one ordinarily skilled in the art of healthcare to modify the combination of Mihai, Heavelyn, and Guerra to incorporate the LED indicator changing colors to represent the changes as taught by Hickle in order to present clear and unambiguous controls and UI designs to prevent user error, e.g. see Hickle [0008].
Regarding Claim 10, the limitations of Claim 10 are substantially similar to those claimed in Claim 2, with the sole difference being that Claim 2 recites a device, whereas Claim 10 recites a method. Specifically pertaining to Claim 10, Examiner notes that Mihai teaches that the invention may be embodied as methods an apparatuses, e.g. see Mihai [0004]-[0005], and hence the grounds of rejection provided above for Claim 2 are similarly applied to Claim 10.
Claims 5 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Mihai, Heavelyn, and Guerra in view of Karol (US 2019/0316948).
Regarding Claim 5, the combination of Mihai, Heavelyn, and Guerra teaches the limitations of Claim 1, and Mihai and Guerra further teaches the following: The infusion device of Claim 1, wherein sending the message to the remote records system comprises:
wherein, on the changed infusion being confirmed at the remote records system, the remote records system creates an association between the changed infusion and the current patient, and begins recording data provided by the infusion device for the changed infusion in association with the current patient (The system tracks data for every step in the infusion administration process including infusion order information and changes in real-time, e.g. see Mihai [0326] and [0328]-[0329], wherein a change may include changing a channel, e.g. see Mihai [0472]-[0474], and wherein a pump may include different medications for different channels, e.g. see Guerra [0070].).
Furthermore, before the effective filing date, it would have been obvious to one ordinarily skilled in the art of healthcare to modify the combination of Mihai and Heavelyn to incorporate the new medication and tracking the infusion of the new medication as taught by Guerra in order to make it easier to track multiple medications and reduce and/or eliminate opportunities for abuse or diversion, e.g. see Guerra [0029].
But the combination of Mihai, Heavelyn, and Guerra does not teach and Karol teaches the following:
instructing the remote records system to buffer infusion data pertaining to the new medication until the changed infusion is confirmed at the remote records system (The system includes an automation computer that controls the therapy devices and a user interface computer that enables data exchange, e.g. see Karol [0560], wherein the data signals from the therapy devices are stored in a buffer memory until called for by the automation computer and validated for use by a receiving computer, e.g. see Karol [0617]-[0618], and wherein the therapy devices are configured to accept changes to the therapy by a user, e.g. see Karol [0812].).
Furthermore, before the effective filing date, it would have been obvious to one ordinarily skilled in the art of healthcare to modify the combination of Mihai, Heavelyn, and Guerra to incorporate recording the swap from the old drug profile to the new drug profile upon swapping to the new drug as taught by Shelton in order to ensure that the new drug is properly delivered with regards to safety and efficacy, e.g. see Shelton [0004].
Regarding Claim 13, the limitations of Claim 13 are substantially similar to those claimed in Claim 5, with the sole difference being that Claim 5 recites a device, whereas Claim 13 recites a method. Specifically pertaining to Claim 13, Examiner notes that Mihai teaches that the invention may be embodied as methods an apparatuses, e.g. see Mihai [0004]-[0005], and hence the grounds of rejection provided above for Claim 5 are similarly applied to Claim 13.
Claims 7-8 and 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Mihai, Heavelyn, and Guerra in view of Kamen (US 2013/0177455).
Regarding Claim 7, the combination of Mihai, Heavelyn, and Guerra teaches the limitations of Claim 1, but does not teach and Kamen teaches the following: The infusion device of Claim 1, wherein the control unit is further configured to:
display on the display screen an indication that the remote records system is not synchronized with the changed infusion to include the association between the changed infusion and the current patient or the infusion device (The system checks every adjustment against a series of defined limits and displays an alert (i.e. an indication that the remote records system is not synchronized with the changed infusion) when the change is greater than a predefined percentage, e.g. see Kamen [0927].);
prompt for a confirmation to proceed with the changed infusion (Each alert may require confirmation before performing the adjustment and moving on to the next step, e.g. see Kamen [0927].);
adjusting infusion parameters on the infusion device to implement the change to the infusion when the confirmation is received (The system makes the adjustment after confirmation, e.g. see Kamen [0927].); and
terminating the changed infusion when the confirmation is not received (The system stops the infusion until the user confirmation has been received, e.g. see Kamen [0927].).
Furthermore, before the effective filing date, it would have been obvious to one ordinarily skilled in the art of healthcare to modify the combination of Mihai, Heavelyn, and Guerra to incorporate requiring confirmation of the changes as taught by Kamen in order to improve safety and provide more opportunities for user input errors to be caught, e.g. see Kamen [0914].
Regarding Claim 8, the combination of Mihai, Heavelyn, Guerra and Kamen teaches the limitations of Claim 7, and Kamen further teaches the following: The infusion device of Claim 7, wherein the control unit is further configured to, when the confirmation is not received:
determine a second infusion being provided by the infusion device (The system may be configured to provide multiple infusions via multiple pumps, wherein the alert issued requiring user confirmation may be issued pertaining to any of the infusions from any of the pumps, e.g. see Kamen [0930], Fig. 303.); and
terminating the second infusion (The system stops the infusion in the alert until the user confirmation has been received, e.g. see Kamen [0930].).
Furthermore, before the effective filing date, it would have been obvious to one ordinarily skilled in the art of healthcare to modify the combination of Mihai, Heavelyn, and Guerra to incorporate requiring confirmation of the changes for each of the infusions as taught by Kamen in order to improve safety and provide more opportunities for user input errors to be caught, e.g. see Kamen [0914].
Regarding Claims 15-16, the limitations of Claims 15-16 are substantially similar to those claimed in Claims 7-8, with the sole difference being that Claims 7-8 recites a device, whereas Claims 15-16 recites a method. Specifically pertaining to Claims 15-16, Examiner notes that Mihai teaches that the invention may be embodied as methods an apparatuses, e.g. see Mihai [0004]-[0005], and hence the grounds of rejection provided above for Claims 7-8 are similarly applied to Claims 15-16.
Response to Arguments
Applicant’s arguments, see Remarks, filed February 18, 2026, with respect to the rejections of Claims 7-8 and 15-16 under 35 U.S.C. 112(b) have been fully considered and, in combination with the claim amendments, are persuasive. The rejections of Claims 7-8 and 15-16 under 35 U.S.C. 112(b) have been withdrawn.
Applicant’s arguments, see Remarks, filed February 18, 2026, with respect to the rejections of Claims 1-2, 5-10, and 13-16 under 35 U.S.C. 101 have been fully considered but are not persuasive.
Applicant first alleges that the claimed invention recited in Claims 1-2, 5-10, and 13-16 is patent eligible because it recites a specific physical medical device, name an infusion device, that performs the claimed operations, and is hence not properly characterized as reciting an abstract idea, e.g. see pgs. 8-9 of Remarks – Examiner disagrees.
Examiner first notes that the evaluation of whether or not the claims recite the implementation of an abstract idea with or using a particular machine is considered in prong 2 of step 2A and/or step 2B, e.g. see MPEP 2106.04(d)(I) and 2106.05(b). That is, a claim that recites a particular machine implementing an abstract idea still nonetheless recites an abstract idea, but may be found to be eligible under prong 2 of step 2A and/or step 2B of the two-step analysis. Hence, Applicant’s arguments regarding the “particular machine” will be addressed below with regards to prong 2 of step 2A and step 2B.
Regarding prong 1 of step 2A, Examiner notes that the claims are not directed towards the particulars of a hardware machine itself, but instead are directed towards the functional operations performed by a machine. That is, Applicant has not invented a specific type of infusion pump, but instead recites the use of an infusion pump to perform the claimed functions. The claimed invention is not deemed patent eligible merely because it involves the use an infusion pump recited at a high level of generality. Hence, Examiner maintains that the claimed invention of Claims 1-2, 5-10, and 13-16 is properly characterized as reciting the abstract idea of a certain method of organizing human activities, specifically following rules or instructions in performing an infusion process.
Regarding prong 2 of step 2A and step 2B, as noted above, the language of Claims 1-2, 5-10, and 13-16 recite that a control unit “[provides], using the pump, an intravenous infusion of a first medication to a current patient.” However, this language represents the only operation performed in Claims 1-2, 5-10, and 13-16 that actually involve a physical product (i.e. the medication itself being provided via intravenous infusion), and this operation is recited at a high level of generality. That is, the intravenous infusion providing the medication merely represents an insignificant application because it is performed entirely unrelated to/independent from the subsequent data processing steps. This is in contrast to the invention recited in Claims 7-8 and 15-16, which, as stated above, actually performs concrete operations (i.e. adjusting infusion parameters, terminating infusion) on a physical product (i.e. the medications) that is being handled by the infusion pump that is specifically configured to perform these steps (i.e. a particular machine).
Applicant further alleges that the claimed invention of Claims 1-2, 5-10, and 13-16 is patent eligible because it improves safety and reliability of computerized infusion systems, e.g. see pgs. 9-10 of Remarks – Examiner disagrees.
Examiner asserts that the problem of “inaccurate or mismatched infusion records when a medication change occurs mid-infusion” is not a technical problem, but instead represents a problem in the process of medical recordkeeping and/or a problem with the process of providing a patient with an infusion, both of which are problems that have existed since long before the advent of any type of computer technology. Hence, an improvement to the aforementioned problems would represent, at most, an improvement to the abstract idea of a certain method of organizing human activities, and an improvement in the abstract idea itself is not an improvement in technology, e.g. see MPEP 2106.05(a)(II).
Similarly, performing a real-time comparison of infusion changes and altering how infusion data is recorded also represent problems in the process of medical recordkeeping and/or a problem with the process of providing a patient with an infusion, and hence are not properly interpreted as technological problems, and any improvement to the aforementioned problems represent, at most, an improvement to the abstract idea of a certain method of organizing human activities, and an improvement in the abstract idea itself is not an improvement in technology, e.g. see MPEP 2106.05(a)(II).
Additionally, even assuming, arguendo, that the claimed invention “governs machine behavior,” it does not automatically follow that the claimed invention is patent eligible. For example, an invention that recites a generic computer programmed to perform a particular function represents an invention that “governs machine behavior,” but said generic computer is not automatically deemed patent eligible.
For the aforementioned reasons, Claims 1-2, 5-10, and 13-16 are rejected under 35 U.S.C. 101.
Applicant’s arguments, see Remarks, filed February 18, 2026, with respect to the rejections of Claims 1, 6, 9, and 14 under 35 U.S.C. 102(a)(1) have been fully considered and, in combination with the claim amendments, are persuasive. The rejections of Claims 1, 6, 9, and 14 under 35 U.S.C. 102(a)(1) have been withdrawn. However, Claims 1, 6, 9, and 14 are nonetheless rejected under 35 U.S.C. 103 for the reasons disclosed above.
Applicant’s arguments, see Remarks, filed February 18, 2026, regarding the previous rejections under 35 U.S.C. 103 have been considered but are moot because the arguments do not apply to any of the references being used in the current rejection.
As stated above, the newly amended claim limitations of Claims 1 and 9 has necessitated the new grounds of rejection. For example, Mihai is not cited to teach the newly amended language that defines the change as a change from a first medication to a new medication, and Guerra is now cited to address this limitation.
Hence Claims 1-2, 5-10, and 13-16 are rejected under 35 U.S.C. 103 for the reasons disclosed above.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/JOHN P GO/Primary Examiner, Art Unit 3681