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 § 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) 11-14, 17 and 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent EP 196784 to Cox et al. (Cox, copy attached) in view of US Pre-Grant Publication 2019/0154470 to Pusheck et al. (Pusheck) and US Pre-Grant Publication 2009/0118667 to Haueter et al. (Haueter hereinafter).
Regarding claim 11, Cox teaches a pressure detection system comprising: a body (11) comprising a chamber (containing pressure P) having an exposed opening through a left side of the body and a flexible membrane (1) fluidically sealed to the exposed opening such as to prevent the fluid from passing through the exposed opening, and configured to change shape responsive to a pressure caused by the fluid accumulated within the chamber satisfying a predetermined threshold, the flexible membrane comprising one or more markings (etching) on a surface (5) of the flexible membrane that deform when the flexible membrane changes shape, a housing (3, 4, 6) above the chamber and having a larger (outer) diameter than the chamber such that the chamber expands into the housing (at 4), housing comprising a floor (6) that circumscribes the exposed opening and comprising at least one wall that partially forms a well (4) within which the flexible membrane is positioned and expands, wherein the flexible membrane is sealed by way of a frame (2) that traverses along and conforms to an inner (right hand) side of the at least one wall of the well with the frame constraining the flexible membrane between the floor and the frame or between the wall and the frame, wherein the housing is separated from but configured to couple to a coupling mechanism of an image sensing device (7).
Cox does not teach a snap-fit cover. Pusheck teaches another pressure sensor generally, and particularly teaches that a cover (130, 152) of a sensor (100) may snap on (via 152) to align and secure the sensor (paragraph 17, orientation). One of ordinary skill in the art would have found it obvious before the effective filing date of the application to us a sensor cover as taught by Pusheck with the sensor of Cox, in order to align and secure the sensor (7) thereof.
Cox further does not teach an input port and an output port, the chamber being configured to accumulate fluid from an upstream portion of an infusion line fluidly coupled to the input port, and to supply the fluid to a downstream portion of the infusion line fluidly connected to the output port. Haueter teaches a pressure detection system comprising: a body (21) comprising a chamber (12), an input port (14a) and an output port (14b), the chamber having an exposed opening (facing toward 20) through a side of the body and being configured to accumulate fluid from an upstream portion (2) of an infusion line fluidly coupled to the input port, and to supply the fluid to a downstream portion (2, 22) of the infusion line fluidly connected to the output port; and a flexible membrane (7) fluidically sealed to the exposed opening such as to prevent the fluid from passing through the exposed opening, and configured to change shape responsive to a pressure caused by the fluid accumulated within the chamber satisfying a predetermined threshold (e.g. “change in pressure”, paragraph 66), the flexible membrane comprising one or more markings (13, paragraph 68) on a surface of the flexible membrane that deform when the flexible membrane changes shape. Haueter teaches that this allows for sensing of pressure in an infusion system, or alternatively, the infusion itself.
Regarding claim 12, Haueter teaches an image sensing device (10), processors (paragraph 57), and configuration to cause the image sensing device to read the markings (paragraph 68), measure a current variation from a default state (“the distances of the elements 13 from one another change”, paragraph 68), and provide an indication of current pressure based on the variation (“identify the change in pressure”, paragraph 68). One of ordinary skill in the art would have found it obvious before the effective filing date of the application to use an image sensor as taught by Haueter in place of the fiber optic element of Cox in order to simplify and make more compact the system thereof, or alternatively to use the simpler or alternative pressure sensing structure of Haueter.
Regarding claim 13, Haueter teaches determining correspondence with a predetermined threshold pressure (“previously stored specified value”, paragraph 73) and providing a notification (“suitable alarm”, paragraph 73) in regard thereof.
Regarding claim 14, Haueter teaches determining that the infusion pump has initiated an infusion (see paragraph 60, “only when the insulin is delivered is it checked whether the membrane 7 has a bulge”). Haueter further teaches activating the sensor (10), capturing an image (paragraph 68), comparing the image to one or more predetermined patterns (lattice, paragraph 36) and determining an overpressure (paragraph 73, “previously stored specified value”), periodically (e.g. every 10 seconds, paragraph 38), and providing an alert (“suitable alarm”, paragraph 73).
Regarding claim 17, Haueter teaches determining non-correspondence with a predetermined threshold pressure (“previously stored specified value”, paragraph 73) and providing a notification (e.g. the absence of the “suitable alarm”, paragraph 73) in regard thereof.
Regarding claim 19, Haueter teaches a flat shape (e.g. Fig. 5a) at a first predetermined pressure threshold, and a convex shape (Fig. 5b) and a second pressure threshold. Haueter further teaches that the markings may be a pattern of lines (e.g. a lattice paragraph 36), and that the processors are configured to detect and match the pattern of curved lines with one or more predetermined patterns (e.g. by change in distance between lines, per paragraph 36). In a digital system, this is tantamount to indexing a matched pattern.
Regarding claim 20, Haueter teaches determination of an expansion state of the membrane based on the markings (paragraph 36) based on an amount of shape change and to determine pressure differential based thereon (from “base signal”, see paragraph 71).
Claim(s) 15, 16 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cox in view of Pusheck and Haueter as applied to claim 12 above, and further in view of WO 2017/002023 to Eitan et al. (Eitan, copy provided herewith).
Regarding claim 15, the previously applied references teach determining that the infusion pump has initiated an infusion (see Haueter, paragraph 60, “only when the insulin is delivered is it checked whether the membrane 7 has a bulge”). Haueter further teaches activating the sensor (10), capturing an image (paragraph 68), comparing the image to one or more predetermined patterns (lattice, paragraph 36) and determining an overpressure (paragraph 73, “previously stored specified value”), periodically (e.g. every 10 seconds, paragraph 38), and providing an alert (“suitable alarm”, paragraph 73). Haueter does not teach stopping infusion responsive to the signal. Eitan teaches another infusion system generally, and particularly teaches that when an alarm state is reached, infusion may be stopped (see e.g. paragraph 60, “an associated medical device may be stopped”) to prevent harm to a patient. One of ordinary skill in the art would have found it obvious before the effective filing date of the application to stop the infusion of insulin in the pump of Haueter as taught by Eitan in order to prevent harm to the patient upon detection of the over-pressure condition.
Regarding claims 16 and 18, Haueter teaches the limitations of claim 15 as discussed above, but does not teach the limitation of determination of infusion based on the image sensing device. Eitan teaches that priming (e.g. an initiation of infusion) may be verified by a pressure sensor (paragraph 10). Eitan teaches that this provides information about the pumped fluid (paragraph 10). One of ordinary skill in the art would have found it obvious before the effective filing date of the application to use the pressure sensing image detection device of Haueter to determine initiation of infusion as taught by Eitan in order to provide additional information about the fluid being infused.
Response to Arguments
Applicant’s arguments, see page 9, filed 25 February 2026, with respect to the rejection(s) of claim(s) under 35 U.S.C. 102 and 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 Cox and Pusheck as set forth 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.
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/PHILIP E STIMPERT/Primary Examiner, Art Unit 3783 29 May 2026
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