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 .
Response to Amendment
This office action is responsive to the amendment filed on 1/23/26. As directed by the amendment: claims 26 and 57 have been amended, claims 1-25, 35-53, and 58 have been cancelled, and no new claims have been added. Thus, claims 26-34, 54-57, and 59-65 are presently pending in this application, claims 31-34, 54-56, 61, and 65 being withdrawn from consideration.
The amendments to the claims are sufficient to overcome the rejections under 35 U.S.C. 112(b) from the previous action.
Claim Objections
Claims 31-34, 54-56, 61, and 65 are marked with the (Withdrawn) status identifier; however, the full text of these claims is missing from the claim set filed 1/23/26. The full text of the withdrawn claims should be included in the next filing unless the claims are to be cancelled, in which case the appropriate status identifier (Canceled) should be utilized. Appropriate correction is required.
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) 26, 28-30, 57, 59, 60, and 62-64 is/are rejected under 35 U.S.C. 103 as being unpatentable over Peterfreund et al. (US 20140303591) in view of El-Khatib et al. (US 20210016006).
Regarding claim 26, Peterfreund et al. discloses a noninvasive drug level estimator pump (fig. 1A), the pump comprising: a memory (par. 0148) configured to store a drug library (par. 0088), the drug library comprising a drug half-life (par. 0127) and two or more fields selected from the following group: drug name, concentration or container volume, dosing unit, lower limit, upper limit, catch-up dose permission, maximum catch-up dose, drug expiration, and drug source (par. 0088-0090); the memory further configured to track and record pump behavior (par. 0091-0101); a processor (par. 0010-0011) configured to use the drug library and pump behavior to calculate predicted drug levels in the patient without input from in-vivo sensors (par. 0091-0101); and an interface configured to display the predicted drug levels and periodic pump behavior indicators (par. 0013, 0016, 0046). Peterfreund et al. further discloses utilization of pump motor or actuator pauses to achieve low flow rates (par. 0036; dispensing a predetermined amount of fluid repeatedly after predetermined time intervals), but fails to disclose the tracked and recorded pump behavior specifically comprises pump motor or actuator pauses used to achieve a low flow rate, and/or pauses due to an air or bubble, kinked line or other occlusion alarm, pump repositioning, infusion line disconnection or replacement, movement to another hospital room, replacement of syringe or IV bag and/or battery limitations. However, El-Khatib et al. teaches tracking and recording the number of times that operation has been paused (par. 0175), and further teaches utilizing this tracked behavior as a pump input (par. 0163-0168). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the pump of Peterfreund et al. to utilize tracked and record pump behavior in the form of number of times that operation has been paused, as taught by El-Khatib et al., for the purpose of providing sufficient functionality to monitor type of interval based flow rates described in Peterfruend et al. par. 0036 for the purposes of pump/dosage control.
Regarding claim 28, Peterfeund et al. discloses the pump as claimed, except for the memory is further configured to store a patient profile, the patient profile comprising demographic, medical, or identifying data specific to the patient. However, El-Khatib et al. teaches utilizing patient demographic/medical data to generate control algorithms for pump delivery (par. 0230). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the pump of Peterfreund et al. to store patient demographic/medical data, as taught by El-Khatib et al., for the purpose of tailoring control algorithm values to the particular patient (par. 0230).
Regarding claim 29, Peterfreund et al. discloses the pump behavior includes real-time information concerning forward fluid flow and paused fluid flow (par. 0046; par. 0091-0101).
Regarding claim 30, Peterfreund et al. discloses the pump behavior includes total volume infused (par. 0105).
Regarding claim 57, Peterfreund et al. discloses an interface configurable for selecting an infusate delivery rate (par. 0013, 0016, 0018, 0046, 0077); a pump mechanism 105a/b/c configured to achieve the selected infusate delivery rates and, for low selected rates, use intermittent mechanical movement having periodic pauses (par. 0036); the memory further configured to store pump mechanism operation details and to store information that associates infusate delivery rates with pump mechanism operation details (par. 0076); the processor configured to accept the selected infusate delivery rate, access the memory, and use the pump operation details to calculate expected infusate arrival time (par. 0091-0101); and the user interface configurable to provide a clinician with selected infusate delivery rate and an expected infusate arrival time (par. 0013, 0016, 0018, 0046, 0077), except for disclosing the pump mechanism operation details specifically comprising length and frequency of the pump motor or actuator pauses that have actually occurred. However, El-Khatib et al. teaches, as noted for claim 26 above, tracking and recording the length and frequency of times that operation has been paused (par. 0175), and further teaches utilizing this tracked behavior as a pump input (par. 0163-0168). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the pump of Peterfreund et al. to utilize tracked and record pump behavior in the form of length and frequency of pauses, as taught by El-Khatib et al., for the purpose of providing sufficient functionality to monitor type of interval based flow rates described in Peterfruend et al. par. 0036 for the purposes of pump/dosage control
Regarding claim 59, Peterfreund et al. disclosed feedback sensors positioned within the infusion pump, wherein the processor is further configured to accept input from these sensors and account for this input in the expected infusate arrival time provided through the user interface (par. 0047, 0099).
Regarding claim 60, Peterfreund et al. discsloses the memory stores information incorporating pharmacodynamic models specific to the type of medication being delivered (par. 0088), and the processor is further configured to account for this input in displaying the predicted drug level through the user interface (par. 0088-0101).
Regarding claim 62, as best understood, Peterfreund et al. discloses the pump as claimed, except for the computer memory is further configured to store patient characteristics received from a user interface or a hospital information system, those received characteristics comprise a patient's sensitivity to a particular medication, and the processor is further configured to combine these characteristics with the pharmacodynamic models in calculating and displaying predicted drug levels through the at least one user interface. However, El-Khatib et al. teaches medicament sensitivity levels as a parameter in the tracking of administered therapy (par. 0145). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the pump of Peterfreund et al. to utilize patient drug sensitivity its calculations, as taught by El-Khatib et al., since El-Khatib et al. teaches that such a parameter can change over time and have an effect on therapeutic levels (par. 0145).
Regarding claim 63, Peterfreund et al. discloses the drug library includes data accounting for drug decay from at least one of metabolization, diffusion, and absorption and: taken from at least one empirical data source; using a pulished in-vivo half-life; or output from a two-compartment pharmacodynamics model (par. 0127).
Regarding claim 64, Peterfreund et al. discloses the user interface is further configurable to provide at least one of the following: the present effective expected drug level with respect to a predicted or desired equilibrium level (par. 0091-0101).
Claim(s) 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Peterfreund et al. in view of El-Khatib et al., and further in view of Gannon et al. (US 20110072381).
Regarding claim 27, Peterfreund et al. discloses the pump as claimed, except for the processor is further configured to compare a drug expiration to an expected drug arrival time and the pump is configured to alert a user if the drug will expire before it is predicted to reach the patient. However, Gannon et al. teaches comparing drug expiration to drug expiration and sending a notification when the drug will expire before reaching the patient (par. 0090-0093). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the pump of Peterfreund et al. to include sufficient structure and functionality to notify a user when drug will expire prior to delivery, as taught by Gannon et al., for the purpose of preventing the patient from receiving expired drug and/or enabling adjustment to delivery parameters to ensure drug is delivered prior to expiration.
Response to Arguments
Applicant's arguments filed 1/23/26 have been fully considered but they are not persuasive.
Applicant argues, on pg. 5-6 of the Remarks, that Peterfreund et al. fails to disclose newly amended limitations of claim 26. In response to those amendments, Peterfruend et al. is now modified by El-Khatib et al. in rejection of claim 26, as set forth above, to address these limitations. Applicant additionally argues that Peterfruend et al. fails to disclose calculating predicted drug levels without input form in-vivo sensors. However, particularly in at least cited par. 0099, Peterfruend et al. discloses predicting an arrival drug concentration based on modelling.
Applicant further argues, on pg. 6-7 of the Remarks, that El-Khatib et al. only discloses providing a report of information and nothing of the report being used by the processor. Examiner respectfully disagrees. Specifically, in addition to par. 0175, see the discussion of par. 0163-0168 of El-Khatib et al., as cited in the rejection of claim 26 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATHAN R PRICE whose telephone number is (571)270-5421. The examiner can normally be reached Mon-Fri 8:00am-4:00pm Eastern time.
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/NATHAN R PRICE/Primary Examiner, Art Unit 3783
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