DETAILED ACTION
Status of Claims
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This action is in reply to a response filed 13 June 2026, on an application filed 2 April 2025, which claims domestic priority to a provisional application filed 12 April 2024.
Claims 1-3, 5-11 and 13-15 have been amended.
Claim 12 has been canceled.
Claims 1-11 and 13-15 are currently pending and have been examined.
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 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 of this title, 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 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 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.
Claims 1-11 and 13-15 are rejected under 35 U.S.C. 103 as being obvious over Webha, further in view of Coyne et al. (U.S. PG-Pub 2023/0390483 A1), hereinafter Coyne.
As per claims 1 and 13-15, Webha discloses a computer program comprising instructions stored in a non-transitory computer readable medium, a method and a medical system for documenting and managing an administration procedure of drugs, the medical system (Webha, see Figs. 1 and 13.) comprising:
a server implementing a clinical healthcare protocol comprising a drug administration procedure and a documentation procedure (See MMU server #3108 of Figs. 1 and 13, which implements a clinical healthcare protocol, such as entered orders, see paragraphs 10-12 and 63-68, corresponding to a documentation procedure, see documentation form screen of Fig. 6 and paragraphs 67, 77 and 141.);
at least one infusion pump configured to administer an infusion to a patient in accordance with the drug administration procedure implemented by the server, the at least one infusion pump being in data communication with the server and providing status information to the server (Webha, see infusion pump that communicates with MMU server of Figs. 1 #3130 and Fig. 13 in order to provide infusion to the patient in accordance with the drug administration procedure [orders], see paragraphs 63-68.); and
a mobile device configured to receive input information from a user in accordance with the documentation procedure, the mobile device being in data communication with the server and providing the input information to the server (Webha, see POC client/system/PDA that communicates with MMU server of Figs. 1 #3126 and Fig. 13. POC device can be wireless handheld device, see paragraph 10. User documents administration corresponding to procedure, see documentation form screen of Fig. 6 and paragraphs 67, 77 and 141. Also see wherein the system prompts a user for needed information corresponding to documentation requirements, such as height missing a valid number or units of paragraph 70.),
wherein the server is configured to provide drug administration instructions to the at least one infusion pump to infuse at least one drug in accordance with the drug administration procedure and the at least one infusion pump is configured to administer the at least one drug to a patient in response to the drug administration instructions from the server for implementation of the drug administration procedure (Webha, system operative to provide infusion corresponding to orders, see paragraphs 70-77.), and
wherein the server is further configured to receive the status information from the at least one infusion pump and the input information from the mobile device, to process the status information and the input information to determine whether the drug administration procedure and the documentation procedure of the clinical healthcare protocol are being followed, and to submit a notification comprising at least one of a drug infusion instruction to the at least one infusion pump or a warning to the mobile device instructing the user what input information to provide and when, based on whether the drug administration procedure and the documentation procedure of the clinical trial protocol are being followed (Webha, system operative to provide infusion corresponding to orders, see paragraphs 70-77. Webha, server is operative to validate a programming pump request “documentation of the administration protocol” sent from the POC #3126 and based on status information from the pump, such as the pump currently being in use, see paragraph 70. System provides a notification to caregiver to start the infusion pump by pressing the start button, see paragraph 76.).
Webha fails to explicitly disclose using the system in operation with a clinical trial.
Coyne teaches that it was old and well known in the art of healthcare communications before the effective filing date of the claimed invention to utilize a drug infusion system in operation with a clinical trial (Coyne, paragraph 29.).
Therefore, it would have been obvious to one of ordinary skill in the art of healthcare communications before the effective filing date of the claimed invention to modify the drug infusion system of Webha include operations within a clinical trial, as taught by Coyne, in order to produce a clinical trial that utilizes modern treatment procedures via a drug infusion system. 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 Webha and Coyne are directed to the electronic processing of patient healthcare data and specifically to a drug infusion treatment method.
As per claims 2-11 and 14, Webha/Coyne discloses claims 1 and 13, discussed above. Webha also discloses:
2. wherein the server is configured to at least one of store drug administration information or receive the drug administration information from a hospital information system that is in data communication with the server (MMU stores drug libraries, see Webha paragraphs 8-10 and 57.);
3. wherein the drug administration information comprises identification information and the server is configured to automatically link the drug administration information to the documentation procedure through the identification information (MMU uses drug libraries that identify drugs to check against the programming parameters sent by the POC; see Webha paragraphs 8-11.);
4. wherein the server is configured to send infusion order information based on the drug administration information to the at least one infusion pump (MMU validates order information input by POC, determining whether it is within an acceptable range before sending to the pump, see paragraphs 11 and 70.);
5. wherein the server is configured to at least one of receive an approval input that approves the documentation procedure or any changes made to the documentation procedure before sending the infusion order information based on the drug administration information to the at least one infusion pump (POC nurse enters adjusted program settings to the MMU, which then transmits order to the pump, see paragraphs 85-86 and 129-130.);
6. wherein at least one of the status information provided by the at least one infusion pump or the input information provided by the mobile device comprise time stamp information (Webha, paragraph 149: “The MMU 3108, 3208 can automatically expire unutilized pump programs or send alarms or error messages to the pump 3130, 3230 and/or POC system 3125, 3225 when a time stamp from the MMU or POC system indicates a program age greater than a predetermined program age.”);
7,14. wherein the server is configured to determine if the input information is being received by the mobile device at least one of in an established order or in a timely manner in accordance with the documentation procedure, based on the time stamp information, and to submit a warning to the mobile device if the input information has not been received in the established order or in a timely manner (Webha, paragraph 149: “The MMU 3108, 3208 can automatically expire unutilized pump programs or send alarms or error messages to the pump 3130, 3230 and/or POC system 3125, 3225 when a time stamp from the MMU or POC system indicates a program age greater than a predetermined program age.”);
8. wherein the server is configured to analyze/compare the status information provided by the at least one infusion pump and/with the input information received by the mobile device to determine if the documentation procedure is being followed (Webha, server is operative to validate a programming pump request “documentation of the administration protocol” sent from the POC #3126 and based on status information from the pump, such as the pump currently being in use, see paragraph 70.);
9. wherein the input information received by the mobile device is at least one of binary or descriptive and comprises parameter values or text data (Webha, paragraph 95: “ the POC client 3126 then sends or transmits the medical device specific identification information, such as the pump ID, the caregiver specific identification information, such as the nurse's ID, the patient specific identification information, such as the patient ID, the order ID obtained or retrieved from one of the drug container specific identification information or from the associated medication order stored in the memory associated with the POC computer 3124, 3224 and/or POC client 3126, and the medical device specific delivery information, such as the pump settings for the order, to the MMU computer”.);
10. wherein the status information provided by the at least one infusion pump comprises at least one of infusion start time, infusion end time, infusion flow rate, administered drug dose, or drug name Webha, paragraph 163: “The pump 3130, 3230 continuously sends status information (i.e., current settings and state) and event logs (i.e., historical activity, alarms, alerts, overrides, etc.) to the MMU 3108, 3208 pursuant to step 4002.”); and
11. wherein the server is configured to determine if the input information provided by the mobile device is erroneous or illogical input information that would falsify the drug administration procedure and submits the warning to the mobile device when the input information is determined to be erroneous or illogical input information that would falsify the drug administration procedure (Webha, server is operative to validate a programming pump request “documentation of the administration protocol” sent from the POC #3126 and based on status information from the pump, such as the pump currently being in use, see paragraph 70: “If the validation is unsuccessful, the MMU 3108 notifies the PDA 3126 via a program pump reply message and does not transform or send the order to the infusion pump 3130. Likewise, if the infusion pump 3130 is currently infusing, the MMU 3108 will reject the request and indicate with an error description in the program pump reply that the infusion pump 3130 is not ready to receive an order.”).
Response to Arguments
Applicant’s arguments filed 13 June 2026 concerning the rejection of all claims under 35 U.S.C. 101 and 112 have been fully considered and are persuasive in view of the amendments to the claims. Accordingly, these rejections have been withdrawn.
Furthermore, in regards to patent-eligibility under 35 U.S.C. §101, Applicant’s claimed invention is patent-eligible because of comparison to elements of Examples 37, 39 and 42 from the 2019 PEG. A system that utilizes and controls a drug infusion to a patient corresponding to a drug administration procedure would be a practical application of an abstract idea that otherwise would be defined as an abstract idea overall. Alternatively, the limitations amount to “significantly more’ than the abstract idea. For at least these reasons, the claims are patent eligible under 35 U.S.C. §101.
Applicant’s arguments filed 13 June 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 prior art rejection of the independent claims, Applicant argues on pages 9-12 that the amendments to the claims overcome the application of Webha.
Applicant's arguments have been fully considered but are moot in view of the new ground(s) of rejection, specifically with reference to the new citation of the previously cited reference, Coyne, as necessitated by amendment, as detailed above, or because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references.
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 Webha and Coyne, 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 Action (13 March 2026), and incorporated herein.
Conclusion
Unused but cited relevant prior art includes:
Hanina et al. (U.S. Patent 9,183,601 B2) discloses a method and apparatus for collection of protocol adherence data for use in confirming administration of a medication in a clinical trial or other medication administration scenario.
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 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.
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/MARK HOLCOMB/
Primary Examiner, Art Unit 3685
14 August 2026
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