DETAILED ACTION
Status of Claims
The present application is being examined under the pre-AIA first to invent provisions.
This action is in reply to a request for continued examination (“RCE”) filed 23 February 2026, on an application filed 27 December 2021, which claims domestic priority to provisional applications filed as far back as 12 December 2011.
On 4 April 2024, the Applicant filed and the Office accepted a terminal disclaimer for this application over U.S. Patent No. 11,210,611.
Claims 1, 11 and 12 have been amended.
Claims 1-12 are currently pending and have been examined.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 23 February 2026 has been entered.
EXAMINATION NOTE
The Office notes that the claims contain multiple terms that are not explicitly defined in the claims or the specification as filed. Therefore, the Office is providing the following definitions under a broadest reasonable interpretation analysis.
The online Wiktionary dictionary defines:
web service as a “software system designed to support interoperable machine to machine interaction over a network.”
web server as “software that delivers web pages and other documents to browsers using the HTTP protocol.”
The online Wikipedia describes a gateway as “a link between two computer programs or systems such as Internet Forums. A gateway acts as a portal between two programs allowing them to share information by communicating between protocols on a computer or between dissimilar computers.”
The online Computer Desktop Encyclopedia describes a web client as “[t]he client, or user, side of the Web. It typically refers to the Web browser in the user's machine.”
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), first paragraph:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-12 are rejected under 35 U.S.C. 112, first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 1, 11 and 12 recite the steps of authentication by a hub. The patent application does not provide adequate support for this limitation. For example, the specification, in paragraph [0545] states that a request “may optionally originate from any authorized, authenticated, and/or identified monitoring client”. However, this does not support the limitation indicating that the hub does authentication of any devices. Therefore, one skilled in the art of healthcare intervention, upon reading the specification, would not conclude that the inventor had possession of the claimed inventions on the day the application was filed.
To the extent that other claims rely on claims that are rejected under 35 USC 112 and fail to correct the deficiencies of the claims they rely on, those other claims are rejected for the same reasons as the claims they rely on. Appropriate correction is required.
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 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(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) 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.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
Claims 1, 4-7 and 9-12 are rejected under 35 U.S.C. 103(a) as being obvious over Holland et al. (U.S. PG-Pub 2005/0144043 A1), hereinafter Holland, in view of Baldus et al. (U.S. PG-Pub 2007/0271115 A1), hereinafter Baldus, further in view of Golden (U.S. PG-Pub 2010/0292556 A1), hereinafter Golden.
As per claims 1, 11 and 12, Holland discloses a method and system for electronic patient care (Holland, Figs. 1A and 5.), the system comprising:
a server configured to have an electronic medical records (“EMR”) database (Holland discloses Medication Administration Record [MAR] system #22 of Fig. 1, see paragraph 65.);
a hub configured to have a medical device application being executed within the hub (Holland discloses Medication Management Unit [MMU] #12, see paragraphs 69-71.); and
a plurality of medical devices including a pump, each configured to treat a patient and have … communications with the hub (Holland discloses medical device #14, which is connected to Hub. Hub is operative to control multiple pumps, see paragraphs 27, 28, 69, 74-76. Holland discloses the use of Bluetooth communications, which are known to be paired, see paragraphs 6, 56, 69, 74, 75, 100, 109, 120 and 144.);
a tablet configured to: … and having a user interface and … communications with the hub (Holland discloses PDA #32 containing a user interface, see paragraphs 84 and 154. Holland discloses the use of Bluetooth communications, which are known to be paired, see paragraphs 6, 56, 69, 74, 75, 100, 109, 120 and 144. User must be authorized/authenticated by presentation of a badge or similar article, see paragraph 143; only an authorized/authenticated user can communicate with the hub using the tablet, therefore the communications are authorized and authenticated.); wherein:
when a user updates a prescription within an EMR application via the tablet, the EMR application queries the electronic medical record database on the server to determine safety of the updated prescription for the patient (Holland, Fig. 5 #S 136-140 and paragraph 84: user enters patient ID into PDA ##32 which forwards that to the HIS #18 that communicates with MAR #22, see paragraph 65; HIS responds with a task list for the patient in order to provide a 5-rights check to determine the safety of the prescription for the patient. Accordingly, the EMR application accessed by HIS #18 is utilized by PDA #32 in order to determine the safety of the prescription for the patient. MMU performs the safety check in an alternative embodiment, see paragraph 84. In another embodiment at paragraph 103 updated information is provided to the system, and HIS #18 [that communicates with MAR #22, see paragraph 65] determines whether the an updated order would be safe by. In yet another embodiment, system uses HIS/MMU to access patient photograph information to determine the five-rights check, see paragraph 129. See also the five rights check used by accessing HIS #18 of paragraph 145.);
the server is configured to communicate the determined safety of the updated prescription for the patient to the EMR application (Validated orders are confirmed back to the PDA at step 158. MMU again confirms safety of prescription at Fig. 5A #178 and relays confirmation at 180 to the PDA, see Holland paragraphs 88-90.);
the hub is configured to communicate the updated prescription to the pump (Prescription sent to pump 14 with patient-specific rule set, see Holland paragraph 89 and Fig. 5A #182.);
the pump is configured to infuse the updated prescription into the patient after a user confirms the updated prescription on the user interface of the pump (Fig. 5A #198.),
the pump is configured to infuse a parameter to the hub (Delivery Events are communicated from the pump to the MMU [hub] to the PDS [tablet], see Fig. 5A #200-204 and paragraph 94.); and
the hub is configured to communicate the parameter to the tablet which displays the parameter on the user interface of the tablet upon receipt (Delivery Events are communicated from the pump to the MMU [hub] to the PDS [tablet], see Fig. 5A #200-204 and paragraph 94.);
the hub, the tablet and the pump must be all be available prior to configuration and treatment of the patient (System does not operate without all parts, see Holland Fig. 5A.); and
11,12. the user interface is configured to display a confirmation request of the updated prescription on a user interface of the pump (Prescription presented on pump interface at Fig. 5A #188 to be confirmed by provider, see Holland paragraph 91.).
Holland fails to explicitly disclose:
A tablet that is authenticated by said hub;
the hub includes first and second processors;
paired communications between devices;
the hub, the tablet, and the pump each include a ranging module; and
devices must be within a predetermined distance relative to each other as indicated by the respective ranging module prior to operate.
Baldus discloses wherein:
three devices each include a ranging module (Baldus, discloses a ranging module system for inclusion with at least three devices, such as patient sensor system “CCC”, hospital staff and patient monitors, see paragraphs 37, 40, 41, 61 and 62.) ; and
three devices must be within a predetermined distance relative to each other as indicated by the respective ranging module prior to operate (Baldus discloses a system wherein the monitor display is turned off when rules are not met, such as patient CCC, patient monitor and hospital staff being within a detectable vicinity of the location device 19, see paragraphs 37, 40, 41, 61 and 63.),
in order to provide “as a function of the determined location of the medical device, to provide automatic configuration or adaptation of configuration to the new situation of the medical device” (Baldus, paragraph 8.).
Therefore, it would have been obvious to one of ordinary skill in the art of healthcare data processing at the time of the invention/filing to modify the medication management system of Holland to include three devices containing a ranging module that must be determined to be within a particular distance, as taught by Baldus, in order to provide a medication management system wherein “as a function of the determined location of the medical device, to provide automatic configuration or adaptation of configuration to the new situation of the medical device” (Baldus, paragraph 8.).
Neither Holland nor Baldus disclose device to device authentication, a multiprocessor device, nor paired communications between devices.
Golden, however, teaches that it was old and well known in the art of patient monitoring and treatment application at the time of the invention/filing to provide device to device authentication (See paragraphs 109: “may also be configured to authorize and grant/deny access to a secure environment operating on a medical device. This feature prohibits unauthorized devices and/or medical applications from communicating with the medical device”), two or more processors dedicated separately to the secure and the non-secure sides (See Fig. 2A #250 and corresponding text.), and paired communications between devices (Golden, disclose the use of a secure communication environment, see paragraph 109. The online dictionary Wiktionary defines pairing as “to link two electronic devices wirelessly together, especially through a protocol such as Bluetooth.”), in order to provide “methods and systems for managing, controlling and monitoring medical devices via a software application functioning in a secure environment” (Golden, paragraph 2).
Therefore, it would have been obvious to one of ordinary skill in the art of healthcare data processing at the time of the invention/filing to modify the medication management system of Holland/Baldus to include use of a multiprocessor device that enables device to device authentication and pairing, as taught by Golden, in order to result in a medication management system that provides “methods and systems for managing, controlling and monitoring medical devices via a software application functioning in a secure environment” (Golden, paragraph 2).
Holland, Baldus and Golden are all directed to the processing of healthcare data to provide care to a patient. Moreover, merely adding a well-known element into a well-known system, to produce a predictable result to one of ordinary skill in the art, does not render the invention patentably distinct over such combination (see MPEP 2141).
As per claims 4-7, 9 and 10, Holland/Baldus/Golden disclose claim 1, discussed above. Holland also discloses:
4. wherein a medical device of the plurality of medical devices is an infusion pump (Holland, hub is operative to control multiple pumps, see paragraphs 27, 28, 69, 74-76.);
5. wherein the hub is configured to control access from the medical device application to at least one hardware resource (Holland, MMU hub is operative to control multiple pumps, see paragraphs 27, 28, 69, 74-76.);
6. wherein the hub is configured to prioritize access to an alarm resource (Holland discloses the MMU accessing and controlling an audible alarm, see paragraphs 23-24.);
7. wherein the alarm resource is a speaker (Holland discloses the MMU accessing and controlling an audible alarm, see paragraphs 23-24. It is the Office’s position that given the system of Holland which provides an audible alarm, it would obvious to one of ordinary skill in the art to provide the audible alarm using a speaker.);
9. wherein the tablet is configured to communicate the parameter to the server (All delivery events are communicated to hospital information system, see Fig. 5A #208 of Holland.);
10. wherein the pump is configured to broadcast the parameter (As shown above, Holland discloses a pump transmitting data. The online Wiktionary dictionary defines broadcast as “Communicated, signaled, or transmitted through radio waves or electronic means.” Accordingly, any transmission of data through electronic means would comprise a broadcast, as shown in Holland.).
Claims 2, 3 and 8 are rejected under 35 U.S.C. 103(a) as being obvious over Holland/Baldus/Golden, further in view of Blomquist (U.S. Patent 8,954,336 B2), hereinafter Blomquist.
As per claims 2, 3 and 8, Holland/Baldus/Golden discloses claim 57, discussed above. Holland/Baldus/Golden also discloses 8. wherein the medical device application is configured to route the at least two alarm conditions to the tablet (Holland, Fig. 5A #178.).
Holland/Baldus/Golden fails to explicitly disclose:
2. a gateway, wherein the gateway is configured to provide a web server of a web service and a medical device of the plurality of medical devices is a client of the web service;
3. wherein the web service is a transaction-based web service; and
8. using an Extensible Markup Language (“XML”).
Blomquist teaches that it was old and well known in the art of patient monitoring and treatment application at the time of the invention/filing to include:
2. further comprising a gateway, wherein the gateway is configured to provide a web server of a web service and a medical device of the plurality of medical devices is a client of the web service (Blomquist, C3L61-C4L10, where the pump server serves a web service (web browser interface) to the medical device and Fig. 7. Note the definitions of gateway, web service, web client and web server indicated above. The pump server #100 provides a gateway to communicate with the medical device via a web service, the pump interface driver. See also C3L61-C4L10, where the pump server serves a web service (web browser interface) to the medical device and Fig. 7.);
3. wherein the web service is a transaction-based web service (Blomquist, C3L61-C4L10, where the pump server serves a web service (web browser interface) to the medical device and Fig. 7. This is clearly the transmission and processing of an item of data. Note the definitions of gateway, web service, web client and web server indicated above.); and
8. using an Extensible Markup Language (“XML”) (Blomquist C6L23-26.);
in order to “permit a remote device to communicate with a medical device … without the use of a … server and without the need for a special program or other interface loaded on the remote device” (Blomquist, C2L19-23).
Therefore, it would have been obvious to one of ordinary skill in the art of medical claim analysis and patient treatment at the time of the invention/filing to modify the medication management system of Holland/Baldus/Golden to include a gateway, which is a web server of a web service and the medical device is a client of the web service; and wherein the web service is a transaction-based web service; and wherein the medical device is an infusion pump, in order to provide the medication management system that can “permit a remote device to communicate with a medical device … without the use of a … server and without the need for a special program or other interface loaded on the remote device” (Blomquist, C2L19-23.). Moreover, merely adding a well-known element into a well-known system, to produce a predictable result to one of ordinary skill in the art, does not render the invention patentably distinct over such combination (see MPEP 2141).
Both Holland and Blomquist are directed to the processing of healthcare data to provide care to a patient.
Response to Arguments
Applicant’s arguments filed 23 February 2026 concerning the rejection of all claims under 35 U.S.C. 103(a) have been fully considered but they are not persuasive.
With regard to the rejection of the claims under 35 USC 103, Applicant argues on pages 6-7 that the cited references fail to disclose authentication by a hub.
The Office respectfully disagrees. As shown above, Golden discloses device to device authentication.
Accordingly, the rejection is upheld.
In conclusion, all of the limitations which Applicant disputes as missing in the applied references, including the features newly added by amendment, have been fully addressed by the Office as either being fully disclosed or obvious in view of the collective teachings of Holland, Baldus, Golden and Blomquist, based on the logic and sound scientific reasoning of one ordinarily skilled in the art at the time of the invention, as detailed in the remarks and explanations given in the preceding sections of the present Office Action and in the prior Office Actions (5 September 2025, 20 May 2025, 4 March 2025, 19 September 2024, 14 March 2024 and 30 August 2023), and incorporated herein.
Conclusion
Any inquiry of a general nature or relating to the status of this application or concerning this communication or earlier communications from the Examiner should be directed to Mark Holcomb, whose telephone number is 571.270.1382. The Examiner can normally be reached on Monday-Friday (8-5). If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, Kambiz Abdi, can be reached at 571.272.6702.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MARK HOLCOMB/
Primary Examiner, Art Unit 3685
20 March 2026