DETAILED ACTION
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 .
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-4, 7-11, 14-18 and 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Pre-Grant Publication 2014/0288947 to Simpson et al. (Simpson hereinafter).
Regarding claims 1, 8 and 15, Simpson teaches starting an infusion session (paragraph 206) within a memory (see paragraph 187, store-and-forward requires memory, see also Fig. 4 and paragraph 91) of an infusion device (120) responsive to an administration of a medication (124) to a patient (112) by the infusion device; recording, in the infusion session, first physiological data associated with the patient (see paragraph 173, e.g. blood pressure or weight, paragraph 271), and a plurality of modifications (paragraph 219) to one or more operating parameters of the infusion device; receiving, from the infusion device, a request (via PumpDataListener function, see paragraph 121) to send a selected portion of the infusion session to a remote device (e.g. PDA), the selected portion of the infusion session being defined by a start time and an end time selected at the infusion device (see e.g. paragraph 206, “end-of-shift” including start time, end time); providing (via the PumpDataListener function), to the remote device over a network, from the infusion device, the portion of the infusion session corresponding to the start time and the end time, the portion of the infusion session including a subset of the first physiological data (paragraph 227, “criteria can include values for various parameters related to patient condition”) and a subset of the plurality of modifications received at the infusion device (paragraph 219); generating a graphical representation of the infusion session for display at the remote device (paragraph 99), the graphical representation including a graphical visualization (408) of the subset of the first physiological data and the subset of the plurality of modifications (514) received at the infusion device; receiving, from the remote device, an updated operating parameter (e.g. 516) provided to the graphical visualization, the updated operating parameter corresponding to at least one of the subset of the plurality of modifications; and providing the operating parameter to the infusion device, wherein the updated operating parameter is displayed by a display screen of the infusion device (paragraph 300) and the administration of the medication to the patient is adjusted based on the updated operating parameter (paragraph 302, “new flow rate”). Regarding the “while the infusion session is ongoing” limitation of claim 8, the examiner notes that Simpson discloses the provision of real-time data, per at least paragraph 168.
Regarding claims 2, 9 and 16, Simpson teaches identifying, based on physiological data, an alert condition (paragraph 244) indicative on an undesirable response, generating a workflow for resolving the condition (see paragraph 396, workflow including “steps to take to resolve the problem”) and providing a graphical representation of the workflow (e.g. paragraph 396, “message accompanying this indication”).
Regarding claim 3, 10 and 17, Simpson teaches displaying the graphical representation of the workflow, receiving user input to adjust or enter operational parameters according to the workflow (paragraph 430, “condition may be resolved at the medical device”).
Regarding claims 4, 11 and 18, Simpson teaches at least a partial copy of a user interface from the infusion pump at pharmacy (see paragraphs 222-223).
Regarding claims 7, 14 and 20, Simpson teaches assigning a pseudo identifier (paragraph 361, data can be entered manually) at the infusion system (paragraph 288), receiving modifications (514) to the infusion parameters and adjusting infusion based thereon, receiving further physiological data (paragraph 244) which are indicative of a response to the adjusted administration, recording the modifications and data (see again PumpDataListener, paragraph 121 and others), receiving a known medication identifier (512a, see paragraph 332) after adjustments and assigning it to the infusion session in substitution for the pseudo identifier, and generating a graphical representation (paragraph 295) of the session including the modifications and physiological data.
Claim Rejections - 35 USC § 103
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) 5-6, 12-13 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Simpson in view of US Pre-Grant Publication 2014/0236617 to Oberfest et al. (Oberfest).
Regarding claims 5, 12 and 19, Simpson teaches associating an identifier (112a) with a patient, receiving modifications (514), modifying the infusion, receiving second physiological data (paragraph 244), recording the data and the modifications (PumpDataListener paragraph 121), and assigning the data to the identifier. Simpson does not teach assigning and replacing a pseudo-identifier. Oberfest teaches another infusion management system, and particularly teaches assigning a pseudo-identifier, verifying identity, and subsequently assigning data to a verified patient identifier in substitution of the pseudo-identifier (paragraph 61). Oberfest teaches that this allows data-sharing without sensitive information transfer (paragraph 60). One of ordinary skill in the art would have found it obvious before the effective filing date of the application to use a pseudo-identifier and accompanying process steps as taught by Oberfest with the system of Simpson in order to allow for data sharing without sensitive information transfer.
Regarding claims 6 and 13, Simpson teaches that multiple modifications (514) may be received, implemented (paragraph 121), and recorded (e.g. paragraph 244).
Response to Arguments
Applicant's arguments filed 29 December 2025 have been fully considered but they are not persuasive.
With respect to applicant's argument that "[g]enerating a report is not the same as starting an infusion session within a memory of an infusion device", the examiner is not persuaded. First, Simpson does explicitly teach that the medical device (100) may be an infusion pump or controller (paragraph 91), and that the medication manager (302) is part of such a device (as illustrated in Fig. 4). Second, there is at least overlap between the reports disclosed by Simpson and the broadest reasonable interpretation of "an infusion session". The infusion session is required only to record physiological data, modifications to operating parameters, and a start and end time selected at the infusion device. As discussed above, the reports of Simpson may include all of these elements and therefore satisfy all requirements of the claimed "infusion session". Furthermore, the examiner is unaware of any scenario in which the reports of Simpson would be operably distinct from administration of medication via the infusion device, as parameters of that session are recorded in the reports. Applicant also argues that their specification defines the term “infusion session”, but as this definition is prefaced by “[f]or the purpose of this disclosure”, it is not clear that this definition extends into the claims.
Regarding physiological data, the examiner notes that at least physiological data relating to weight is utilized (paragraph 271).
Regarding modifications, the examiner notes Fig. 6, and in particular modifications (514) discussed with reference thereto (paragraph 239).
In view of the above, the examiner maintains that the claimed invention does not patentably distinguish over the cited prior art.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PHILIP E STIMPERT whose telephone number is (571)270-1890. The examiner can normally be reached Monday-Friday, 8a-4p.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at 571-270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PHILIP E STIMPERT/Primary Examiner, Art Unit 3783
23 April 2026
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