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
The amendment filed 03/23/2026 has been entered. Claim 1-3, 5-16, 19-20, 24 are pending in the application.
Claim Objections
Claim 16 is objected to because of the following informalities:
Claim 16: on line 3, “optical elements configure to” is grammatically incorrect and should recite “optimal element configured to”.
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.
The factual inquiries 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 1-3, 5, 7, 9, 16, 19-20, 24 are rejected under 35 U.S.C. 103 as being unpatentable over Jacobson (US 2009/0157040) in view of Newberry (US 2017/0014035).
Regarding Claim 1, Jacobson discloses a monitoring device (100, Fig 2) comprising: a reusable housing (104, Fig 3) comprising attachment means for releasably attaching said reusable housing directly to a body part of a user (See Fig 2; “secured on the patient 10”, Para 0033), said reusable housing being configured to receive and hold a removable sensor module (102, Fig 3) having one or more sensor elements (110, 116, Fig 4) for measuring at least one property or condition of a fluid media received from an external source and streamed through said removable sensor module for delivery to said user (Para 0038); electrical circuitry (124, Fig 4) provided in said reusable housing and configured to: (i) acquire measurement data/signals from the one or more sensor elements of said removable sensor module (Para 0038); and (ii) generate based on (I) the measurement data/signals from said removable sensor module, control data/signals for controlling flow rate of said fluid media by an internal or external flow control device (Para 0017, Para 0039); and a display (Para 0039)
Jacobson is silent regarding at least one sensing device mounted to a body-facing surface of said reusable housing and configured to non-invasively measure one or more physiological parameters directly from a tissue of said body part of the user; generate based on at least on both (I) the measurement data/signals from said removable sensor module and (II) said at least one sensing device mounted to the body-facing surface of said reusable housing, control data/signals for controlling flow rate; a display for presenting data or alerts indicative of: (a) the measurement data/signals from said removable sensor module; and (b) the one or more physiological parameters from said at least one sensing device mounted to the body-facing surface of the reusable housing.
Newberry teaches a monitoring device (50, Fig 2) configured for controlling flow rate; wherein at least one sensing device (110, Fig 16A) mounted to a body-facing surface of said reusable housing (See Fig 16A) and configured to non-invasively measure one or more physiological parameters directly from a tissue of said body part of the user (Para 0058); generate based on said at least one sensing device mounted to the body-facing surface of said reusable housing, control data/signals for controlling flow rate (Para 0062, 0155); a display (118, Fig 2) for presenting data or alerts indicative of: (a) the one or more physiological parameters from said at least one sensing device mounted to the body-facing surface of the reusable housing (Para 0063).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed by Jacobson to include a sensing device mounted to a body-facing surface of the housing and a display for presenting sensor data as taught by Newberry in order to adjust drug delivery based on biosensor data to automatically treat a condition (Para 0062, 0155) and for the user to easily monitor and view the data from the sensor (Para 0145).
Regarding Claim 2, the modified invention of Jacobson and Newberry discloses the electrical circuitry is configured to wirelessly communicate the measurement and/or the control data/signals to one or more external devices (Para 0039 -Jacobson).
Regarding Claim 3, the modified invention of Jacobson and Newberry discloses one or more processors configured to generate the control data/signals (Para 0020, 0039 -Jacobson)
Regarding Claim 5, the modified invention of Jacobson and Newberry discloses the fluid media streamed through the removable sensor module comprises a medicament (Para 0035 -Jacobson).
Regarding Claim 7, the modified invention of Jacobson and Newberry discloses the at least one sensor element of the removable sensor module is configured to measure one or more of the following: pressure of the streamed fluid media; flow rate of the streamed fluid media (Para 0038 -Jacobson); temperature of the streamed fluid media and/or of the user; electrical conductivity and/or resistance; dielectric constant and/or dissipation factor of the streamed fluid media; pH level of the streamed fluid media; optical transparency and/or transmission of the streamed fluid media; and/or acoustic signals transferred through the streamed fluid media
Regarding Claim 9, the modified invention of Jacobson and Newberry discloses the housing and the attachment means are configured to form a wrist-wear device (See Fig 2; “secured on the patient 10”, Para 0033 -Jacobson; Examiner notes that the device is shown on a wrist of a patient and thus is a wrist-wear device) (Newberry also teaches a wrist-wear device in Para 0054).
Regarding Claim 16, the modified invention of Jacobson and Newberry discloses the housing and/or the one or more sensor elements of the removable sensor module comprise optical elements configured to measure at least one optical property of the fluid media streamed through the removable sensor module (Para 0066 -Newberry).
Regarding Claim 19, Jacobson discloses a method of controlling fluid flow through a wearable device, the method comprising: attaching a reusable acquisition unit (104, Fig 3) to a body part of a user (See Fig 2; “secured on the patient 10”, Para 0033); connecting fluid supply and dispensing conduits to a removable sensor module (See Fig 2), said removable sensor module having a fluid passage and one or more sensor elements (110, 116, Fig 4) configured to measure one or more properties of fluid media streamed through said fluid passage (Para 0038); removably coupling between said removable sensor module and said reusable acquisition unit for communication of data/signals therebetween; acquiring by said reusable acquisition unit measurement data/signals from the one or more sensor elements of said removable sensor module (Para 0038); generating control data/signals for controlling flow rate of said fluid media by an internal or external flow control device based on the measurement data/signals acquired (I) the removable sensor module (Para 0017, Para 0039); and displaying in a display (Para 0039).
Jacobson is silent regarding said reusable acquisition unit comprising at least one sensing device mounted to a body-facing surface of said reusable acquisition unit and configured to non-invasively measure one or more physiological parameters directly from a tissue of said body part of the user; generate based on at least on both (I) the measurement data/signals from said removable sensor module and (II) said at least one sensing device mounted to the body-facing surface of said reusable housing, control data/signals for controlling flow rate; a display for presenting data or alerts indicative of: (a) the measurement data/signals from said removable sensor module; and (b) the one or more physiological parameters from said at least one sensing device mounted to the body-facing surface of the reusable housing.
Newberry teaches a monitoring device (50, Fig 2) configured for controlling flow rate; wherein at least one sensing device (110, Fig 16A) mounted to a body-facing surface of said reusable housing (See Fig 16A) and configured to non-invasively measure one or more physiological parameters directly from a tissue of said body part of the user (Para 0058); generate based on said at least one sensing device mounted to the body-facing surface of said reusable housing, control data/signals for controlling flow rate (Para 0062, 0155); a display (118, Fig 2) for presenting data or alerts indicative of: (a) the one or more physiological parameters from said at least one sensing device mounted to the body-facing surface of the reusable housing (Para 0063).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed by Jacobson to include a sensing device mounted to a body-facing surface of the housing and a display for presenting sensor data as taught by Newberry in order to adjust drug delivery based on biosensor data to automatically treat a condition (Para 0062, 0155) and for the user to easily monitor and view the data from the sensor (Para 0145).
Regarding Claim 20, the modified invention of Jacobson and Newberry discloses at least one of the following: communicating the measurement data/signals from the reusable acquisition unit to at least one external device (Para 0039 -Jacobson); processing the measurement data/signals and identifying at least one substance contained in the dispensed fluid media; and analyzing the one or more one physiological parameters measured from the at least one sensing devic
Regarding Claim 24, the modified invention of Jacobson and Newberry discloses the electrical circuitry comprises at least one of the following: an energy harvesting module configured to harvest energy for powering the removable sensor module; data/signals communication conductors for communicating data/signals with the removable sensor module, and/or a wireless data communication module for wirelessly communicating data/signals with the removable sensor module, the at least one sensing device mounted to the body-facing surface of the reusable housing, and/or one or more external devices (Para 0039 -Jacobson).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Jacobson (US 2009/0157040) in view of Newberry (US 2017/0014035) and further in view of Lowery (US 8,523,797)
Regarding Claim 8, one or more processors configured to process the measurement data/signals from the one or more sensor elements of the removable sensor module and identify based thereon one or more substances comprised in the streamed fluid media.
Lowery discloses one or more processors configured to process measurement data or signals from the one or more sensor elements of the removable sensor module and identify based thereon one or more substances comprised in the dispensed fluid media (Col 9, line 54 – Col 10, line 17).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the removable sensor module to have a fluid sensor in order to detect and ensure that no air is present in the fluid line (Col 9, line 54 – Col 10, line 17).
Claims 10-15 are rejected under 35 U.S.C. 103 as being unpatentable over Jacobson (US 2009/0157040) in view of Newberry (US 2017/0014035) and further in view of Shmilovich (US 2016/0339431).
Regarding claim 10, the modified invention of Jacobson and Newberry discloses a measurement arrangement comprising: the monitoring device of claim 1 (See rejection of claim 1); and the removable sensor module (102, Fig 3 -Jacobson) removably disposed in the reusable housing (104, Fig 3 -Jacobson) (Para 0035 -Jacobson), wherein at least one of the one or more sensor elements of said removable sensor module made at least partially of polymeric or plastic materials (Col 12, lines 22-28 -Lowery), however, is silent regarding having one or more transducing element formed thereon or therein.
Shmilovich teaches one or more sensor elements (20, Fig 10A) made at least partially of polymeric or plastic materials (“Polymeric materials for fluidic MEMS offer various advantages “, Para 0012) and having one or more transducing elements (88, Fig 10A) formed thereon or therein (Para 0166-0168).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the removable sensor module disclosed by Jacobson with the removable sensor module having a transducer as taught by Shmilovich in order to have a more robust, more durable, and biocompatible sensor module that can be mass produced (Para 0013).
Regarding claim 11, the modified invention of Jacobson, Newberry and Shmilovich discloses the removable sensor module is a disposable sensor module (Para 0035 -Jacobson).
Regarding claim 12, the modified invention of Jacobson, Newberry and Shmilovich the one or more sensor elements comprise electrical contacts (75, Fig 10A -Shmilovich) electrically connected to the one or more transducing elements (88, Fig 10A - Shmilovich) formed on, or at least partially in, a deformable element (53, Fig 10A -Shmilovich) (Para 0166 -Shmilovich).
Regarding claim 13, the modified invention of Jacobson, Newberry and Shmilovich discloses the deformable element (53, Fig 10A - Shmilovich) is made of an integrated multilayered foil or film (See Fig 10B – Shmilovich; This illustrates the deformable member is a film or thin layer).
Regarding claim 14, the modified invention of Jacobson, Newberry and Shmilovich discloses at least one external layer of the integrated multilayered foil or film is configured to enable attachment to an injected molded plastic for assembly in a body of the removable sensor module (Para 0071 - Shmilovich)
Regarding claim 15, the modified invention of Jacobson, Newberry and Shmilovich discloses the one or more transducing elements are configured to form at least one differential pressure measurement circuitry (Para 0078, 0168 - Shmilovich).
Claims 1, 6 are rejected under 35 U.S.C. 103 as being unpatentable over Smoll (US 5,450,758) in view of Jacobson (US 2009/0157040) and further in view of Newberry (US 2017/0014035).
Regarding Claim 1, Smoll discloses a monitoring device comprising: a reusable housing (31, Fig 3) comprising, said reusable housing being configured to receive and hold a removable sensor module (34, Fig 3) having one or more sensor elements (37a-c, Fig 3) for measuring at least one property or condition of a fluid media received from an external source and streamed through said removable sensor module for delivery to said user (Col 5, lines 16-45);
Smoll is silent regarding attachment means for releasably attaching said reusable housing to a body part of a user; at least one sensing device mounted to a body-facing surface of said reusable housing and configured to non-invasively measure one or more physiological parameters directly from a tissue of said body part of the user; electrical circuitry provided in said reusable housing and configured to: (i) acquire measurement data/signals from the one or more sensor elements of said removable sensor module and from said at least one sensing device mounted to the body-facing surface of said reusable housing; and (ii) generate based at least on both (I) the measurement data/signals from said removable sensor module and (II) said at least one sensing device mounted to the body-facing surface of said reusable housing, control data/signals for controlling flow rate of fluid media by an internal or external flow control device; and a display configured to present for presenting data or alerts indicative of: (a) the measurement data/signals from said removable sensor module; and (b) the one or more physiological parameters from said at least one sensing device mounted to the body-facing surface of the reusable housing.
Jacobson discloses an analogous monitoring device (100, Fig 2) comprising: a reusable housing (104, Fig 3) comprising attachment means for releasably attaching said reusable housing directly to a body part of a user (See Fig 2; “secured on the patient 10”, Para 0033), said reusable housing being configured to receive and hold a removable sensor module (102, Fig 3) having one or more sensor elements (110, 116, Fig 4) for measuring at least one property or condition of a fluid media received from an external source and streamed through said removable sensor module for delivery to said user (Para 0038); electrical circuitry (124, Fig 4) provided in said reusable housing and configured to: (i) acquire measurement data/signals from the one or more sensor elements of said removable sensor module (Para 0038); and (ii) generate based on (I) the measurement data/signals from said removable sensor module, control data/signals for controlling flow rate of said fluid media by an internal or external flow control device (Para 0017, Para 0039); and a display (Para 0039)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reusable housing to have an attachment means and modify the device to have an electrical circuitry to acquire measurement data and generate control signals as taught by Jacobson in order to implement the monitoring device in line with an IV to monitor delivered medication and be able to selectively vary the flow rate of the medication based on the flow sensor data (Para 0033, 0020).
The modified invention of Smoll and Jacobson is silent regarding at least one sensing device mounted to a body-facing surface of said reusable housing and configured to non-invasively measure one or more physiological parameters directly from a tissue of said body part of the user; generate based on at least on both (I) the measurement data/signals from said removable sensor module and (II) said at least one sensing device mounted to the body-facing surface of said reusable housing, control data/signals for controlling flow rate; a display for presenting data or alerts indicative of: (a) the measurement data/signals from said removable sensor module; and (b) the one or more physiological parameters from said at least one sensing device mounted to the body-facing surface of the reusable housing.
Newberry teaches a monitoring device (50, Fig 2) configured for controlling flow rate; wherein at least one sensing device (110, Fig 16A) mounted to a body-facing surface of said reusable housing (See Fig 16A) and configured to non-invasively measure one or more physiological parameters directly from a tissue of said body part of the user (Para 0058); generate based on said at least one sensing device mounted to the body-facing surface of said reusable housing, control data/signals for controlling flow rate (Para 0062, 0155); a display (118, Fig 2) for presenting data or alerts indicative of: (a) the one or more physiological parameters from said at least one sensing device mounted to the body-facing surface of the reusable housing (Para 0063).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed by Smoll and Jacobson to include a sensing device mounted to a body-facing surface of the housing and a display for presenting sensor data as taught by Newberry in order to adjust drug delivery based on biosensor data to automatically treat a condition (Para 0062, 0155) and for the user to easily monitor and view the data from the sensor (Para 0145).
Regarding Claim 6, the modified invention of Smoll, Jacobson, and Newberry discloses the at least one sensor element (37a-c, Fig 3) of the removable sensor module comprises electrodes configured to contact the fluid media streamed through the removable sensor module and measure one or more electrical properties thereof (Col 2, lines 60-64 -Smoll).
Response to Arguments
Applicant’s argument filed 03/23/2022, on page 10-19, regarding Lowery and Lin failing to disclose all of the claimed elements have been fully considered but are moot in view of the current rejection that no longer relies on Lowery and Lin to teach most of the claimed elements. While Lowery is still relied on to teach claim 8, it is only to teach the sensor for detecting air in the fluid line.
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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/ANTARIUS S DANIEL/Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
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