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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 18 February 2026 has been entered.
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) 1-2, 11-12 and 21-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent 5,478,211 to Dominiak et al. (Dominiak hereinafter) in view of US Pre-Grant Publication 2019/0294184 to Al Kunaizi et al. (Al Kunaizi).
Regarding claim 1, Dominiak teaches an infusion pump (10), comprising: a pumping mechanism (including at least 86, 132, 140) comprising at least one occluder element (122, 124) configured to compress a fluid tubing (142) filled with a fluid to isolate the fluid in an upstream portion (62) of the fluid tubing from a downstream portion (16) of the fluid tubing when the fluid tubing is received by the infusion pump; a pumping element (120) configured to compress an intermediate portion (140) of the tubing, between the downstream portion and the upstream portion; at least one pressure sensor (126); and a processor (540, 542) configured to: activate the at least one occluder element of an infusion pump to compress a fluid tubing filled to isolate the fluid in an upstream portion of the tubing from a downstream portion of the tubing (e.g. at block 795 in Fig. 36B); and while the fluid tubing is compressed by the occluder element: cause the pumping element to compress an intermediate portion of the fluid tubing, between the downstream portion and the upstream portion, to cause a pressure increase within the intermediate portion of the fluid tubing (block 796); and determine, using the at least one pressure sensor, whether the pressure increase is present in a portion of the fluid tubing on a side, of the activated at least one occluder element, opposite the intermediate portion of the tubing (at block 790, see also col. 37, ln. 55-60). Furthermore, Dominiak teaches upstream (122) and a downstream (124) occluder elements, and also teaches causing tube compression with both (e.g. as in Fig. 31C) with the intermediate portion between. Dominiak does not teach pressure monitoring opposite the intermediate portion relative to a valve. Al Khunaizi teaches a valve integrity checking system generally, and particularly teaches that an increase in pressure downstream of a valve with higher pressure on the opposite side may indicate a leak (paragraph 41), as well as providing an indication of such (paragraph 41, “leak failure signal”). One of ordinary skill in the art would have found it obvious before the effective filing date of the application to use a downstream pressure sensor and a detection of a downstream pressure rise as taught by Al Khunaizi to detect leaks in the system of Dominiak, either in addition to or instead of sensing the pressure loss in the pumping chamber.
Regarding claim 2, Dominiak teaches upstream (122) and a downstream (124) occluder elements, and also teaches causing tube compression with both (e.g. as in Fig. 31C) with the intermediate portion between.
Regarding claims 11 and 21, Dominiak teaches the method of operation and its storage on a non-transitory computer storage medium (see discussion of processor above). Furthermore, Dominiak teaches upstream (122) and a downstream (124) occluder elements, and also teaches causing tube compression with both (e.g. as in Fig. 31C) with the intermediate portion between. Dominiak does not teach pressure monitoring opposite the intermediate portion relative to a valve. Al Khunaizi teaches a valve integrity checking system generally, and particularly teaches that an increase in pressure downstream of a valve with higher pressure on the opposite side may indicate a leak (paragraph 41), as well as providing an indication of such (paragraph 41, “leak failure signal”). One of ordinary skill in the art would have found it obvious before the effective filing date of the application to use a downstream pressure sensor and a detection of a downstream pressure rise as taught by Al Khunaizi to detect leaks in the system of Dominiak, either in addition to or instead of sensing the pressure loss in the pumping chamber.
Regarding claim 12, Dominiak teaches upstream (122) and a downstream (124) occluder elements, and also teaches causing tube compression with both (e.g. as in Fig. 31C) with the intermediate portion between.
Regarding claim 22, as previously discussed, Dominiak teaches the method of operation of claim 11, which includes all steps of the method of claim 22, save for the step of determining whether a pressure decrease is present. Dominiak further teaches monitoring in the intermediate portion for pressure decreases (see full discussion of the Fill and Valve Leak Test Sequence Routine beginning in col. 37, particularly regarding comparisons between pressures “B”-“F”). Furthermore, Dominiak teaches upstream (122) and a downstream (124) occluder elements, and also teaches causing tube compression with both (e.g. as in Fig. 31C) with the intermediate portion between. Dominiak does not teach pressure monitoring opposite the intermediate portion relative to a valve. Al Khunaizi teaches a valve integrity checking system generally, and particularly teaches that an increase in pressure downstream of a valve with higher pressure on the opposite side may indicate a leak (paragraph 41), as well as providing an indication of such (paragraph 41, “leak failure signal”). One of ordinary skill in the art would have found it obvious before the effective filing date of the application to use a downstream pressure sensor and a detection of a downstream pressure rise as taught by Al Khunaizi to detect leaks in the system of Dominiak, either in addition to or instead of sensing the pressure loss in the pumping chamber.
Claim(s) 3-10, 13-20 and 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dominiak in view of Shekalim as applied to their parent claims above, and further in view of U.S. Patent 5,078,362 to Lawless et al. (Lawless) and U.S. Patent 5,217,355 to Hyman et al. (Hyman).
Regarding claims 3 and 13, the previously applied references teach the limitations of the parent claims as discussed above, but does not teach the use of upstream and downstream pressure sensors. Lawless teaches another infusion pump generally and particularly teaches upstream (44) and downstream (56) pressure sensors. Lawless further teaches that these sensors may be used to monitor pump operation (col. 6, ln. 6-14). Additionally, Hyman teaches that system pressures may be monitored to detect leaks and other conditions (col. 2, ln. 28-58). One of ordinary skill in the art would have found it obvious before the effective filing date of the application to provide upstream and downstream pressure sensors to the pump of Dominiak as taught by Lawless in order to monitor operation thereof, including particularly monitoring pressure to detect leaks as taught by Hyman. Those of ordinary skill will appreciate that one of the conditions indicative of the presence of a leak is an increase in pressure in an otherwise unpressurized component, such as an inlet or outlet when isolated from the pumping chamber.
Regarding claim 4, 14 and 23, Dominiak teaches a camshaft (292, 307, 316) configured to cause the upper and lower occluder elements to open and close independently according to a predetermined pattern that corresponds to a degree of rotation of the cam shaft (see e.g. Figs. 18A-18D). Dominiak further teaches rotating the cam shaft (esp. at 316) and thereby locking a cam in place on the cam shaft to thereby cause pumping action (col. 14, ln. 10-29).
Regarding claim 5 and 15, Dominiak teaches rotating in reverse to lock the cam in place, at least temporarily (see col. 14, ln. 30-40).
Regarding claim 6 and 16, Dominiak teaches causing forward rotation (clockwise, 90 degrees, see col. 16, ln. 16-48), after both elements are activated (same citation, valve position 2: both valves closed), not causing a decompression of the tubing, and reverse rotation (counterclockwise, same citation) of smaller magnitude (i.e. during the rotation).
Regarding claim 7 and 17, Dominiak teaches alternation of rotation direction (col. 16, ln. 16-48). It would have been obvious to perform the pressure monitoring of Hyman during each step in order to promptly detect the presence of a malfunction.
Regarding claims 8 and 18, to the extent that the claim defines a “pump maintenance mode”, a mode in which malfunctions are detected appears to satisfy this limitation. Accordingly, the automatic activation of the occluders of Dominiak and the pressure sensing taught by Hyman render these limitations obvious.
Regarding claims 9-10 and 19-20, according to the combination, sensing is performed at both claimed locations, and error signals are responsively generated (see e.g. block 924 of Fig. 36G).
Response to Arguments
Applicant’s arguments, see page 9, filed 18 February 2026, with respect to the rejection(s) of claim(s) under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Al Khunaizi.
Conclusion
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/PHILIP E STIMPERT/Primary Examiner, Art Unit 3746 19 March 2026