DETAILED ACTION
Notice to Applicant
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This communication is in response to the Applicant arguments filed on 11/24/2025. Claims 44-45, 47-55, 57, and 59-63 are pending. Insofar as no claim listing has been provided with the response filed on 11/24/25, the Examiner understands that no additional claim amendments have been made with the 11/24/25 response. The claims of record are those submitted on 7/1/2025.
Information Disclosure Statement
The IDSs filed on 2/18/26 have been considered by the Examiner.
The information disclosure statement filed 11/24/25 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. The IDS has been placed in the application file, but the following references referred to therein have not been considered:
CHAN, Katherine Yin-Yee. "Mitigating Risks Associated with Secondary Intravenous Infusions: An Empirical Evaluation of a Technology-Based, Training-Based, and Practice-Based Intervention." Order No. 1570719 University of Toronto (Canada), 2013. Ann Arbor: ProQuest. Web. 23 Nov. 2024, pp. 182.
WANG et al., "Infusion Monitoring System Based on Wireless Transmission", 2011 4th IEEE International Symposium on Microwave, Antenna, Propagation and EMC Technologies for Wireless Communications, pp. 656-659.
All other references cited on the 11/24/25 IDS have been considered.
Double Patenting
The double patenting rejection of Claims 44-45, 47-55, 57, and 59-63, has been withdrawn in light of the Terminal Disclaimer filed, and approved on 11/24/25.
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.
Claim(s) 44-45, 47-55, 57, and 59-63 is/are rejected under 35 U.S.C. 103 as being unpatentable over Blomquist et al (US 20150081894 A1) in view of Jayant et al (US 20030069963 A), and in further view of Kimoto (US 20070288423 A1)
Claims 44 and 54. Blomquist teaches a system for and method of dynamic configuration of security or network protocol of an infusion pump, the system comprising:
a memory configured to store a hospital policy; and (par. 92-database 504; par. 103-admins. Software; par. 105- a listing of library files available to the administrative software 700. The library files contain one or more libraries, which in turn contain a collection of pump protocols)
a hardware processor (par. 78) configured to:
retrieve the stored hospital policy; (par. 88-90)
determine one or more parameters associated with an infusion pump, wherein the one or more parameters corresponds to stored plurality of parameters in the hospital policy and wherein one or more rules are associated with each of the stored plurality of parameters (par. 56-57- plurality of pump parameters; par. 92; See also par. 100- multiple pump programs reside within the pump 102, and the pump protocol 510 contains a parameter which dictates which pump program is to be used…the pump program within the pump is altered based on one or more of the pump parameters included in the pump protocol 510)
identify one or more rules corresponding to the determined parameter from the stored hospital policy; (par. 103- Once criteria are selected, the administrative software 700 applies rules and other logic that assembles sets of pump parameters into a pump protocol… administrative software 700 might be used to select one delivery pattern and enable bolus delivery if the selected therapy is for delivering pain medication and another delivery pattern and not enable bolus delivery if the selected therapy is for parenteral nutrition; restricting range of permissible delivery rates; See also par. 106-107-access rights and access levels--can be set according to a variety of criteria)
alter a functionality of the infusion pump based on the identified one or more rules. (par. 103, par. 106-107)
Blomquist teaches, wherein the parameter comprises quality of service. (par. 153-alerting user that infusion device is malfunctioning), but does not disclose determining a parameter comprising a quality of service (QoS) parameter corresponding to data traffic.
Jayant discloses a system and method including determining a quality of service (QoS) parameter corresponding to data traffic (par. 44; par. 60: QoS parameters may be transmitted to the expert system as real-time signaling on a per session basis, as a one-time set up per user or client, par. 70-72: to adjust the actual parameters of the user, client, network or source/server to implement the optimization determined by the expert system. The number of bits "N" may depend on the number of states for each of the QoS parameters or on the number of control states of the expert system or both; see also Table 1; ) and determine a priority parameter, wherein the priority parameter is separate from the QoS parameter and corresponds to an operation of the infusion pump. (par. 71-72-providing the dynamic priority calculation/ dynamic prioritization). At the time of filing it would have been obvious to one of ordinary skill in the art to modify the system/method of Blomquist with the teaching of Jayant to include wherein the parameter comprises a quality of service (QoS) parameter corresponding to data traffic and a priority parameter. As suggested by Jayant, one would have been motivated to include this feature to balance quality, complexity, delay, and data rate, thereby minimizing delay and maximizing throughput. (abstract).
Claims 44 and 54 have been amended to recite “wherein the priority parameter is higher for auto programming operation in comparison to downloading an update operation.”
Blomquist and Jayant in combination disclose the method and system of claims 44 and 54 as explained, but do not expressly disclose “wherein the priority parameter is higher for auto programming operation in comparison to downloading an update operation.”
Kimoto discloses a system and method wherein different priorities are given to different operations associated with the functioning of a device. (par. 14- it is possible that control information indicating a priority order of update operations between programs are stored in advance, so as to determine on the basis of this control information; Fig. 3- 4; par. 61: the control information, in which apparatus type information 51, category information 52 in regard to programs and drivers to be employed in the apparatus type concerned, a current version 53 of each program, information 54 indicating a rule for the latest and appropriate combination of a program and a driver among them mentioned in the above, are correlated with each other, are stored for every apparatus type. Par. 62: Each priority order indicated in the control information table 50 shown in FIG. 3 is established on the basis of such a rule that "a priority order of the second program, which influences the operations of the first program, overrides a priority order of the first program". For instance, since the operations of the automatic document feeder (ADF) 32 influence the operations of the engine and the operations of the engine influence the operations of the finisher (FNS) 33, the priority orders of them are established in order of the ADF (1)>the engine (2)>the FNS (3), wherein symbol ">" indicates a term of "being higher than". Further, since the statuses of the apparatuses concerned, such as the engine, the ADF, the FNS, etc., tend to influence the operations and settings of the drivers for them, the priority order of each driver program is set at a level lower than those of the other programs.)
At the time of filing, it would have been obvious to one of ordinary skill in the art to further modify Blomquist and Jayant in combination with the teaching of Kimoto to include a priority parameter which alters the priority of an order of operations for an infusion device (i.e. wherein the priority parameter is higher for auto programming operation in comparison to downloading an update operation.”) One would have been motivated to include this feature to ensure that unnecessary update operations are not conducted, and to prevent program update operations being implemented in a conflicting sequence. (Kimoto: par.7-8 )
claims 45, and 55 Blomquist teaches wherein the parameter alters functionality based on location of the infusion pump. (par. 106- Access levels can be set according to a variety of criteria. Examples include the type of caregiver (e.g., physician, nurse, pharmacist), location (e.g., hospital, clinic, pharmacy, manufacturer), or a particular department within a location; See also par. 109- Entity attributes can be properties specific to the library, such as a name of a doctor, a name of a healthcare regimen, or a location of the medical infusion pump or pump network, for example the hospital or department at which the pump is located.)
Claims 47 and 57: Blomquist discloses the parameter alters functionality based on signal strength. (par. 59-62; par. 77- wired/wireless signal connections)
Claim 48: Blomquist discloses a system/method as explained in the rejections of claims 44. Blomquist discloses, system and method wherein operation comprises an infusion pump programming operation and wherein the rule corresponding to the infusion pump programming operation comprises using a regulated wireless technology. (par. 59-60- the communications link 106 connects the pump 102 and computing system 104. In various embodiments, the communications link 106 can include serial or parallel connections, wired or wireless connections, and a direct or networked connection to a computer. Additionally, the pump 102 and the computing system 104 can communicate using any protocol appropriate for data communication; par. 103-104; See also Bloomquist 11/003,147: par. 17- altered function- manner of communication while programming/being programmed (‘147 is incorporated by reference, published as US 20050177395 A1) which explains that the medical pump 110 has a wireless network connector and can connect directly to the network 11 through a wireless link rather than through a computer 104 or a mobile computing platform 108. In yet another possible embodiment, the medical pump 110 could include a hardwired network connection)
Claims 49 and 59 Blomquist teaches wherein the rule comprises disabling a network interface of the infusion pump. (par. 146- a user of the administrative software 700 to control when protocols become available for use by user software. In some circumstances, it can be advantageous to prevent user software from accessing data, particularly while that data is being edited in the administrative software 700)
Claims 50 and 60 Blomquist discloses the recited system/method as explained in the rejections of claims 44 and 54. Blomquist does not expressly disclose, but Jayant teaches a system and method wherein the rule comprises disabling a device debugging mode of the infusion pump. (par. 39, par. 41-adjusting error checking : in the network protocol process will involve changes to the error checking processes applied to received packets. Error checking is frequently based on error protection coding, also called channel coding… error checking could be modified to reflect the varied levels of importance) At the time of filing, it would have been obvious to one of ordinary skill in the art to modify the system of Blomquist to include these features, with the motivation of maximizing quality provided within constraints by minimizing delay and maximizing throughput. (Abstract)
Claims 51 and 61 Blomquist teaches wherein the rule comprises resetting the infusion pump to a factory default setting. (par. 111; par. 115-the administrative software includes a number of default settings or pump parameter modifications used when specific therapies, qualifiers, or drugs are selected; par. 202)
Claims 52, 62 Blomquist teaches wherein the rule comprises switching network protocol. (par 60-62; See also par. 73)
Claims 53, and 63 Blomquist teaches wherein the hospital policy can be dynamically updated over a network.(par. 109- User attributes define the users allowed to access and modify pump parameters for protocols associated with a particular library by using the medical infusion pump, and can also define users allowed to modify pump protocols using user software; par. 178- user will have a set access level allowing the user to view or edit pump application protocols and parameters within the user software 2600. Access levels are set using the user rights module 716 of the administrative software 700, described above in conjunction with FIG. 7. Access levels can be set by a user of the administrative software 700 according to a variety of criteria)
Response to Arguments
Applicant's arguments filed 11/24/25 have been fully considered but they are not persuasive.
(A) Applicant argues that the Jayant reference does not disclose a priority parameter, in the same way that the claimed invention uses priority parameter.
In response, the Examiner disagrees. The Jayant reference discloses determining a priority parameter which corresponds to an operation of the infusion pump as claimed (e.g. transmission of data). As explained in the rejection Jayant discloses: “the QoS expert system may provide QoS signaling to the application layer, the dynamic priority calculation, the packet replication, packet interleaving, loss recovery, buffer manager, and rate control. For example, the application layer may receive QoS information that adjusts the error correction techniques or the start up delay; the dynamic priority calculation may receive information that adjusts the display rate, the start-up delay, or the E2E delay.”
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). The limitation of “wherein the priority parameter is higher for auto programming operation in comparison to downloading an update operation” has been addressed by the Kimoto reference which teaches Kimoto discloses a system and method wherein different priorities are given to different operations associated with the functioning of a device. (par. 14- it is possible that control information indicating a priority order of update operations between programs are stored in advance, so as to determine on the basis of this control information; Fig. 3- 4; par. 61: the control information, in which apparatus type information 51, category information 52 in regard to programs and drivers to be employed in the apparatus type concerned, a current version 53 of each program, information 54 indicating a rule for the latest and appropriate combination of a program and a driver among them mentioned in the above, are correlated with each other, are stored for every apparatus type. Par. 62: Each priority order indicated in the control information table 50 shown in FIG. 3 is established on the basis of such a rule that "a priority order of the second program, which influences the operations of the first program, overrides a priority order of the first program". For instance, since the operations of the automatic document feeder (ADF) 32 influence the operations of the engine and the operations of the engine influence the operations of the finisher (FNS) 33, the priority orders of them are established in order of the ADF (1)>the engine (2)>the FNS (3), wherein symbol ">" indicates a term of "being higher than". Further, since the statuses of the apparatuses concerned, such as the engine, the ADF, the FNS, etc., tend to influence the operations and settings of the drivers for them, the priority order of each driver program is set at a level lower than those of the other programs.)
(B) Applicant further argues that the “higher priority “ for "auto programming in comparison to downloading an update operation" can refer to in non-limiting embodiment to types of communication protocols to use for different operations of an infusion pump.
In response, the limitations argued by the applicant are not claimed. Applicant appears to argue for a narrower interpretation of the claim language than is required based upon the current claim language. The claims do not recite information regarding communication protocols. The claim language does not explain or specify the type of “operation of the infusion pump.” Moreover, the only explanation of what is being prioritized is the clause “wherein the priority parameter is higher for auto programming operation in comparison to downloading an update operation.” As understood by the examiner, the claim is drawn to prioritization of operations performed by/ with regard to the infusion pump.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Kamen et al (WO 2014/100687 A3) discloses a system and method in which attempts by the device app 14820 to violate the DERS 14826, the local policies 14828, or inhibit the dock/hub 14828 to perform its primary functions (e.g., designated, high-priority functions) will be prevented by other software running on the dock/hub 14812 (e.g., an operating system such as the android operating system, IOs, 30 Linux, Windows, or Windows CE that controls the execution of the sandbox via one or more process control blocks or one or more threads from a thread pool) (par. 00696)
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 Rachel L Porter whose telephone number is (571)272-6775. The examiner can normally be reached M-F, 10-6:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Shahid Merchant can be reached on 571-270-1360. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Rachel L. Porter/Primary Examiner, Art Unit 3626