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 10 June 2025. As directed by the amendment: claims 1, 7, 8, 10, 11, 16, and 19 have been amended, claim 21 has been added, claim 9 has been or remains canceled. Thus claims 1-8 and 10-21 are presently pending in this application.
Response to Arguments
Applicant’s arguments, see REMARKS, filed 10 June 2025, with respect to the rejection(s) under Jang and Biasi have been fully considered and are persuasive. The examiner agrees that Jang and Biasi do not teach the amended limitations of the pressure sensor that is connected to a branch channel. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Hulvershorn et al. (US 9358038 B2) as outlined further below. Additionally, there does not appear to be adequate written description for the amended limitations, therefore a new rejection is made under 35 U.S.C. 112(a), outlined further below.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1 and 19 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claims 1 and 19, the newly amended limitations “at least one pressure sensor within the housing connected to a branch channel that extends from and is in fluid communication with the main fluid channel” were not adequately described in the specification or depicted in the drawings. The only written description of the position of the pressure sensor is “During travel of the fluid 16 to and out the outlet 24, a pressure sensor may be in line but out of constant fluid flow.” in paragraph [0043]. The position of the examiner is that the description of the pressure sensor being “in-line” potentially teaches away from a pressure sensor being in a branch channel as “in-line” generally means within the straight path, specifically not “branched”. The examiner notes that while Fig 5 labels the pressure sensor 304, there is no reason one of ordinary skill in the art would assume the pressure sensor is attached to the branched channel as labeled on page 12 of REMARKS. While a branch channel does appear to exist, without additional description, one of ordinary skill would not understand the pressure sensor to be connected to the branch channel as indicated by the claim.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 3-6, 10-11, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Jang (KR 2017124826 A) in view of Biasi et al. (US 2016/0158437 A1) and Hulvershorn et al. (US 9,358,038 B2).
Regarding claim 1, Jang discloses a fluid delivery device (1 Fig 1), comprising: a housing (main body 1 Fig 1) having an inlet and an outlet (See inlet and outlet of annotated Fig 9 below); a spike member (25 Fig 9) at the inlet defining a portion of a main fluid channel (See dashed arrow in Annotated Fig 9) extending between the inlet and the outlet (Fig 9, see fluid path running through spike, inlet, and outlet); a pump (300 Fig 22, the pump is the assembly of mechanical components of the extrusion chamber shown in Fig 13, [0027]) disposed within the housing for pumping the fluid through the spike member and out the outlet of the housing ([0064] “When the elastic tube 24 is pushed, the liquid in the elastic tube 24 strongly pushes the rotary plate 37 of the extruded reverse osmosis 35 and flows through the choke 42 and the outlet hole 41 to the liquid supply pipe 44 )”); at least one bubble sensor (Detecting means 100, [0088] “Detection means (100) for detecting in real time the current flowing through the motor (12)”) within the housing configured to detect bubbles in fluid passing through the main fluid channel ([0057] infusion of bubbles is determined based on the motor load current, [0081] air present produces a current consistent with Fig 21(d)); at least one visual indicator (including OLED 51, Fig 19) viewable through the housing ([0054] “The operation panel 52 is formed of a transparent window 68 for viewing the OLED 51”); and a controller (400 Fig 22) in communication with the pump, the at least one bubble sensor ([0091] “A microcontroller (400) for controlling the motor driving means (300) according to the input of the detecting means (100) and the input means (200)”), and the at least one visual indicator ([0106] “An OLED 51; The microcomputer 400 displays the input result, the injection progress status, the remaining battery level, the alarm content, and the remaining time so that the user can confirm the operation status of the present invention.”), wherein the controller is configured to detect a presence of air within the main fluid channel based on information received from the at least one bubble sensor ([0115] a current indicative of air within the pump would generate an alarm, [0093] “An alarm means (600) for turning on the LED and generating a sound under the control of the microcontroller (400) according to the input of the detection means (100)”), and activate the at least one visual indicator to provide a notification to a user when the air or occlusion is detected (([0106] “An OLED 51; The microcomputer 400 displays […] the alarm content”).
However, Jang fails to disclose at least one pressure sensor within the housing connected to a branch channel that extends from and is in fluid communication with the main fluid channel, the at least one pressure sensor being configured to detect changes in pressure of the fluid passing through the main fluid channel without restricting fluid flow through the main fluid channel; wherein the controller is configured to detect an occlusion within the fluid channel based on information received from the at least one pressure sensor.
Biasi et al. teaches at least one pressure sensor ([0016] “a pump includes […] a pressure sensor, and a processor.”, 33 Fig 3) within a housing (19 Fig 3) configured to detect changes in pressure of the fluid passing through the fluid channel (56 Fig 3), wherein the controller is configured to detect an occlusion within the fluid channel based on information received from the at least one pressure sensor ([0016] “The processor is configured to, using the pressure signal, determine a downstream occlusion exists when a difference between a peak pressure level and a trough pressure level is greater than a predetermined threshold in a cycle of the plurality of cycles.”). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the device of Jang to include the pressure sensor with the limitations as taught by Biasi et al. to allow the device to determine that an error condition exists for example to determine if an occlusion may be preventing the discharge of liquid to the patient [0662].
Hulvershorn et al. teaches at least one pressure sensor (“pressure transducer” 144 Fig 3A) within the housing (110 Fig 2) connected to a branch channel (“chamber” 130 Fig 3A) that extends from and is in fluid communication with the main fluid channel (Passage 132 Fig 3A), the at least one pressure sensor being configured to detect changes in pressure of the fluid passing through the main fluid channel without restricting fluid flow through the main fluid channel (Col 12 lines 6-13, the pressure sensor detects changes in pressure of the fluid it is in communication with, including the passage, because it is in a branched chamber, it would not restrict fluid flow through the main fluid channel). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the pressure sensor of modified Jang to be positioned as with the limitations as taught by Hulvershorn et al. to provide a chamber such that “Particular sensing elements may detect, measure, or test a property of a substance within the chamber in a manner that avoids direct contact with the substance, while other sensing elements may detect, measure, or test a property of a substance within the chamber by way of direct access to or physical contact with the substance.” (Col 11 Lines 18-23)
Regarding claim 3, modified Jang teaches the device of claim 1. Jang further teaches wherein the inlet of the housing includes a recessed portion (See recessed portion in Annotated Fig 9 below), wherein a portion of the spike member is disposed within the recessed portion (a portion of spike member 25 is disposed within the recessed portion, see Fig 9).
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Regarding claim 4, modified Jang teaches the device of claim 1. Jang further teaches wherein the spike member (25 Fig 9) is connectable to an injection port (6 Fig 4) of an intravenous fluid container (5 Fig 4, [0037] “The spike (25) is inserted into the sealing cap (6) of the fluid bag (5)”).
Regarding claim 5, modified Jang teaches the device of claim 1. Jang further teaches further comprising flexible tubing (44 Fig 9) extending through the outlet of the housing (See annotated Fig 9 below), the flexible tubing comprising a first end connected to the pump (See the first end of tubing 44 being connected to the assembly of mechanical components of the extrusion chamber Fig 9) and a second end outside of the housing comprising a connector (See the needle attached to the second end of the tubing 44 Figs 1 and 5) configured to be connected to an intravenous port (a needle is fully capable of being connected to an intravenous port such as an implanted port-a-cath).
Regarding claim 6, modified Jang teaches the device of claim 1. Jang further teaches wherein the pump comprises a gear motor ([0032] “The motor 12 used in the present invention uses a geared motor”).
Regarding claim 10, modified Jang teaches the device of claim 1. Modified Jang further teaches wherein the controller is configured to identify the occlusion in the main fluid channel based on a detected increase in pressure at the inlet detected by the at least one pressure sensor (the pressure at the inlet would correlate to the peak and trough pressures described in [0016], these are measured by the pressure sensor to identify occlusion, if the pressure at the inlet is increased, the pressure sensor would detect it in the tubing).
Regarding claim 11, modified Jang teaches the device of claim 1. Modified Jang further teaches wherein the at least one visual indicator comprises a first LED element (OLED 51 Fig 19, an OLED is a type of LED element) providing a first visual indication (Visible as shown in Fig 2) and a second LED element (67 Fig 2) providing a second visual indication different than the first visual indication (As shown in Fig 2, the elements are different), and wherein the controller is configured to activate the first LED element of the at least one visual indicator to show a flow rate setting for the pump ([0089] “An input unit 200 for inputting […] an injection speed”, [0103]-[0104], [0106] “An OLED 51; The microcomputer 400 displays the input result,”) and activate the second LED element to provide the notification that the air or occlusion is detected in the main fluid channel ([0093] “An alarm means (600) for turning on the LED and generating a sound under the control of the microcontroller (400) according to the input of the detection means (100)”, [0081] ”a state in which air is mixed into the liquid and the motor load current is reduced”, [0088] “Detection means (100) for detecting in real time the current flowing through the motor”).
Regarding claim 19, Jang discloses a fluid delivery system (Fig 1), comprising: an intravenous fluid container (5 Fig 1) having an injection port (6 Fig 4); and a fluid delivery device for delivery of a fluid contained in the intravenous fluid container (1 Fig 1), the fluid delivery device comprising: a housing (main body 1 Fig 1) having an inlet and an outlet (See inlet and outlet of annotated Fig 9 below); a spike member (25 Fig 9) at the inlet defining a portion of a main fluid channel (See dashed arrow in Annotated Fig 9) extending between the inlet and the outlet (Fig 9, see fluid path running through spike, inlet, and outlet), wherein the spike member is connected to the injection port for receiving the fluid from the intravenous fluid container to the main fluid channel (As shown in Fig 4, [0037] “The spike (25) is inserted into the sealing cap (6) of the fluid bag (5)”); a pump (300 Fig 22, the pump is the assembly of mechanical components of the extrusion chamber shown in Fig 13, [0027]) disposed within the housing for pumping the fluid through the spike member and out the outlet of the housing ([0064] “When the elastic tube 24 is pushed, the liquid in the elastic tube 24 strongly pushes the rotary plate 37 of the extruded reverse osmosis 35 and flows through the choke 42 and the outlet hole 41 to the liquid supply pipe 44 )”); at least one bubble sensor (Detecting means 100, [0088] “Detection means (100) for detecting in real time the current flowing through the motor (12)”) within the housing configured to detect air in fluid passing through the main fluid channel ([0057] infusion of bubbles is determined based on the motor load current, [0081] air present produces a current consistent with Fig 21(d)); at least one visual indicator (including OLED 51, Fig 19) viewable through the housing ([0054] “The operation panel 52 is formed of a transparent window 68 for viewing the OLED 51”); and a controller (400 Fig 22) in communication with the pump, the at least one bubble sensor ([0091] “A microcontroller (400) for controlling the motor driving means (300) according to the input of the detecting means (100) and the input means (200)”), and the at least one visual indicator ([0106] “An OLED 51; The microcomputer 400 displays the input result, the injection progress status, the remaining battery level, the alarm content, and the remaining time so that the user can confirm the operation status of the present invention.”), wherein the controller is configured to detect a presence of air or an occlusion within the main fluid channel based on information received from the at least one bubble sensor ([0115] a current indicative of air within the pump would generate an alarm, [0093] “An alarm means (600) for turning on the LED and generating a sound under the control of the microcontroller (400) according to the input of the detection means (100)”)and activate the at least one visual indicator to provide a notification to a user when the air or occlusion is detected (([0106] “An OLED 51; The microcomputer 400 displays […] the alarm content”).
However, Jang fails to disclose at least one pressure sensor within the housing connected to a branch channel that extends from and is in fluid communication with the main fluid channel, the at least one pressure sensor being configured to detect changes in pressure of the fluid passing through the main fluid channel without restricting fluid flow through the main fluid channel; wherein the controller is configured to detect an occlusion within the main fluid channel based on information received from the at least one pressure sensor.
Biasi et al. teaches at least one pressure sensor ([0016] “a pump includes […] a pressure sensor, and a processor.”, 33 Fig 3) within a housing (19 Fig 3) configured to detect changes in pressure of the fluid passing through the fluid channel (56 Fig 3), wherein the controller is configured to detect an occlusion within the fluid channel based on information received from the at least one pressure sensor ([0016] “The processor is configured to, using the pressure signal, determine a downstream occlusion exists when a difference between a peak pressure level and a trough pressure level is greater than a predetermined threshold in a cycle of the plurality of cycles.”). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the device of Jang to include the pressure sensor with the limitations as taught by Biasi et al. to allow the device to determine that an error condition exists for example to determine if an occlusion may be preventing the discharge of liquid to the patient [0662].
Hulvershorn et al. teaches at least one pressure sensor (“pressure transducer” 144 Fig 3A) within the housing (110 Fig 2) connected to a branch channel (“chamber” 130 Fig 3A) that extends from and is in fluid communication with the main fluid channel (Passage 132 Fig 3A), the at least one pressure sensor being configured to detect changes in pressure of the fluid passing through the main fluid channel without restricting fluid flow through the main fluid channel (Col 12 lines 6-13, the pressure sensor detects changes in pressure of the fluid it is in communication with, including the passage, because it is in a branched chamber, it would not restrict fluid flow through the main fluid channel). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the pressure sensor of modified Jang to be positioned as with the limitations as taught by Hulvershorn et al. to provide a chamber such that “Particular sensing elements may detect, measure, or test a property of a substance within the chamber in a manner that avoids direct contact with the substance, while other sensing elements may detect, measure, or test a property of a substance within the chamber by way of direct access to or physical contact with the substance.” (Col 11 Lines 18-23)
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Jang (KR 2017124826 A) in view of Biasi et al. (US 2016/0158437 A1), Hulvershorn et al. (US 9,358,038 B2), and Miller (US 4,079,737 A).
Regarding claim 2, modified Jang teaches the device of claim 1. However, modified Jang fails to teach wherein the outlet of the housing comprises a luer lock connector configured to be connected to flexible tubing for transporting the fluid away from the delivery device.
Miller teaches a fluid delivery device (Fig 2) wherein the outlet (20C Fig 2) of the housing (14 Fig 4) comprises a luer lock connector (Col 5 lines 28-31 “The outlet 23 is a male extension that permits sealing and securing of the tube extension with a male luer needle adaptor fitting at the other end.”) configured to be connected to flexible tubing (20A Fig 2) for transporting the fluid away from the delivery device (As shown by arrow 23 in Fig 4). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the device of modified Jang to include the connector with the limitations as taught by Miller to permit a secure seal to tubing with a luer connector.
Claims 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Jang (KR 2017124826 A) in view of Biasi et al. (US 2016/0158437 A1), Hulvershorn et al. (US 9,358,038 B2), and Jobst et al. (WO 2010/031559 A1).
Regarding claim 7, modified Jang teaches the device of claim 1. However, modified Jang fails to teach wherein the pump comprises a diaphragm pump comprising a piezoelectric crystal that, when exposed to an applied electrical field, generates pressure for moving the fluid through the main fluid channel.
Jobst et al. teaches a pump comprises a diaphragm pump (Figs 2d-2h and Fig 4) comprising a piezoelectric crystal (39 Fig 2e, [0211] “the actuator 39 can be a piezo crystal”) that, when exposed to an applied electrical field, generates pressure for moving the fluid through the main fluid channel ([0211] “which expands due to the piezoelectric effect when a voltage of the actuation direction B is applied”, the expansion in the B direction, as shown in Fig 2h is a pressure for moving the fluid through the fluid channel 47 as shown in Fig 4). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the pump of modified Jang to include the limitations as taught by Jobst et al. since such a modification is the result of a simple substitution of one known element (gear pump of Jang et al.) for another (piezoelectric diaphragm pump of Jobst et al.) to achieve a predictable result (mechanism for pumping a fluid).
Regarding claim 8, modified Jang teaches the device of claim 7. Modified Jang further teaches wherein the pump comprises a silicone membrane (Jobst et al.- 37 Fig 2g, [0069] “the membranes can be made of an engineering silicone”, [0155] “the membrane 37 is formed by the cured silicone mixture 33”) connected to the piezoelectric crystal ([0200] “The actuator 39 and its electrical leads 61 are arranged within an actuation channel layer 43 on the membrane 37.”), and wherein, when exposed to the electrical field, the piezoelectric crystal reciprocally moves the silicone membrane (See the movement between Fig 2g and 2h, [0212] “If the actuator 39 returns to its rest position, the resilient membrane 37 also returns to the rest position.”) to draw fluid into a pump chamber (flow channel 47 Fig 2g, 4) of the pump and to expel the fluid from the pump chamber to the main fluid channel (as shown by flow direction F in Fig 4).
Claims 12-15 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Jang (KR 2017124826 A) in view of Biasi et al. (US 2016/0158437 A1), Hulvershorn et al. (US 9,358,038 B2), and O’Boyle (US 4,822,344 A).
Regarding claim 12, modified Jang teaches the device of claim 1. Jang further teaches wherein the pump is configured to operate at a plurality of discrete flow rate values ([0103]-[0104] the injection rate is changed in discrete increments of 5mL/hr), and wherein the controller selectively controls the pump to operate at one of the plurality of predetermined discrete flow rate values ([0091] “A microcontroller (400) for controlling the motor driving means (300) according to the input of the detecting means (100) and the input means (200)”).
However, Jang fails to disclose the plurality of discrete flow rate values are predetermined.
O’Boyle teaches a plurality of predetermined discrete flow rate values (Col 4 line 36 “a series of predetermined liquid flow rates”, see the discrete flow rates in Fig 1, Col 4 line 60 - Col 5 line 1 “the possible positions include: an OFF position where no flow is permitted through the device 1; an ON position which provides a short, relatively large cross-sectional area passage for relatively unrestricted flow of liquid through the device; and a series of nine numerically labelled positions which can be individually selected to incrementally vary the flow rate through the device 1 from, for example, 83 milliliters per hour to 250 milliliters per hour, as illustrated on the dial cover 7 in FIG. 1.”). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the flow rate values of Jang to be predetermined as taught by O’Boyle to limit the flow rate options to commonly used options to make the flow rate selection faster.
Regarding claim 13, modified Jang teaches the device of claim 12. Jang further teaches further comprising a flow rate selector button ([0103]-[0104] “Increase injection rate (ml / hr) button 55 Increase injection rate by 5 ml / hr.” “The injection rate (ml / hr) reduction button 56 decreases the injection rate by 5 ml / hr.”) that allows a user to select the flow rate of the fluid from the plurality of predetermined discrete flow rate values (the modification in view of O’Boyle would result in the flow rates being predetermined values).
Regarding claim 14, modified Jang teaches the device of claim 12. However, modified Jang fails to teach wherein the at least one visual indicator comprises a plurality of flow rate indicator elements, each of which is representative of one of the plurality of predetermined discrete flow rate values of the pump.
O’Boyle teaches at least one visual indicator comprises a plurality of flow rate indicator elements (the dial cover 7 Fig 1 includes a plurality of flow rate indicator elements in the form of a plurality of numerically labelled positions), each of which is representative of one of the plurality of predetermined discrete flow rate values of the pump (each of the plurality of numerically labeled positions on the dial cover 7 Fig 1 is representative of the predetermined discrete flow rate, col 5 lines 1-3 “The plurality of respective flow rates are attained because the rotation of the dial cover 7 to position the respective indicia thereon”). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the at least one visual indicator of modified Jang to include the limitations as taught by O’Boyle to limit the flow rate options to make the flow rate selection faster. For example, if the user needs to increase the flow rate from 100 mL/hr to 250 mL/hr, rather than pressing a button to increase the flow rate by 5 mL/hr 30 times, the user could quickly select one from a few available flow rates and with the predetermined flow rates visible on the device, the user would immediately know the various flow rates the device is capable of and would be able to determine if the device is suitable for their needs.
Regarding claim 15, modified Jang teaches the device of claim 14. Modified Jang further teaches wherein the plurality of flow rate indicator elements (Jang teaches the flow rate indicator comprises OLED 51 Fig 19, the modification with O’Boyle would result in a plurality of flow rate indicators each comprising the OLED as taught by Jang) comprise the plurality of predetermined discrete flow rate values (Jang- [0092]” Display means (500) for displaying on the OLED information such as an input result set by the user”, the flow rate is an input result) that are illuminated when the flow rate indicator element is activated (when an OLED is activated to show information it is illuminated).
However, modified Jang is silent to wherein the plurality of predetermined discrete flow rate values comprise numerals.
O’Boyle further teaches wherein the plurality of predetermined discrete flow rate values comprise numerals (See the numerals on the dial Fig 1). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the flow rate values of modified Jang to be represented in numerals so the flow rates can be easily identified regardless of the language spoken by the user.
Regarding claim 17, modified Jang teaches the device of claim 1. Modified Jang further teaches wherein the each of plurality of flow rate indicator elements each comprise a first LED element (Jang teaches the flow rate indicator comprises a first LED element- OLED 51 Fig 19, an OLED is a type of LED element, the modification with O’Boyle would result in a plurality of flow rate indicators each comprising the OLED as taught by Jang) that is selectively activated by the controller (Jang teaches the flow rate indicator is controlled by the controller, O’Boyle teaches selectively indicating each of a plurality of flow rate indictors) providing a first visual indication (Jang- [0092]” Display means (500) for displaying on the OLED information such as an input result set by the user”) and a second LED element (Jang- 67 Fig 2) providing a second visual indication different than the first visual indication (As shown in Fig 2, the elements are different), and wherein the controller is configured to activate the first LED element of one of the flow rate indicator elements to show the selected discrete flow rate value of the pump ([0089] “An input unit 200 for inputting […] an injection speed”, [0103]-[0104], [0106] “An OLED 51; The microcomputer 400 displays the input result,”) and activate the second LED element to provide the notification that the air or occlusion is detected to the user ([0093] “An alarm means (600) for turning on the LED and generating a sound under the control of the microcontroller (400) according to the input of the detection means (100)”, [0081] ”a state in which air is mixed into the liquid and the motor load current is reduced”, [0088] “Detection means (100) for detecting in real time the current flowing through the motor”).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Jang (KR 2017124826 A) in view of Biasi et al. (US 2016/0158437 A1), Hulvershorn et al. (US 9,358,038 B2), O’Boyle (US 4,822,344 A), and Crone et al. (US 2016/0144148 A1).
Regarding claim 18, modified Jang teaches the device of claim 17. However, modified Jang fails to teach further comprising a light bar, wherein the light bar includes a third LED element comprising a scrolling LED element that is activated by the controller when a power button of the infusion device is pressed and the fluid is moving through the pump.
Crone et al. teaches an apparatus display (Fig 4) comprising a light bar (screen 400 Fig 4), wherein the light bar includes a third LED element ([0057] “the display screen 40 comprises an organic light-emitting diode (OLED) screen.”) comprising a scrolling element (405a-c Fig 4, [0066] “FIG. 4 illustrates a sequence of images that shows scrolling text 405a, 405b, 405c, moving across a bottom portion of the screen.”) that is activated by the controller ([0019] “the controller is configured to change the text information of the scrolling text in the first portion of the display screen in response to user input or a triggering event”) when a power button (42 Fig 1) of the device is pressed and fluid is moving through the device ([0014] the flow generator generates a flow of breathable gas, [0068] the scrolling text of the display provides information regarding resistance to flow and user breathing rates, such information would be gathered when the device is turned on and air is moving through the device). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the infusion pump of Jang to include the light bar limitations as taught by Crone et al. so the device of Jang can convey information to the user regarding the function of the device that might not fit in the space provided on the screen; by allowing text or images to scroll across the screen, a larger amount of information can be conveyed to the viewer.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Jang (KR 2017124826 A) in view of Biasi et al. (US 2016/0158437 A1), Hulvershorn et al. (US 9,358,038 B2), and Whitney et al. (US 4,150,672 A).
Regarding claim 20, modified Jang teaches the fluid delivery system of claim 19. Jang further teaches wherein the fluid delivery device and the intravenous fluid container are configured to be worn by the patient as the fluid is delivered to the patient (the pump and fluid container are fully capable of being worn by the patent as the fluid is delivered, the entire assembly could rest upon the patents lap during treatment in the same way a blanket is worn).
However, modified Jang fails to teach the system further comprising a carrying strap attached to the intravenous fluid container configured to secure the intravenous fluid container to an arm of the patient.
Whitney et al. teaches a carrying strap (401 Fig 22) attached to the intravenous fluid container (container 10 which holds ampule 11 Figs 1 and 2, see attachment in Fig 22) configured to secure the intravenous fluid container to an arm of the patient (See securement to arm in Fig 21). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the medical infusion system of modified Jang to include the carrying strap with the limitations as taught by Whitney et al. “to conveniently attach the injection devices […] on the patient so that the portability of the invention does not restrict the ambulatory capability of the patient” (Col 20 lines 27-30).
Allowable Subject Matter
Claims 16 and 21 are allowed.
The following is a statement of reasons for the indication of allowable subject matter:
The closest art of record is Jang et al. (KR 2017124826 A).
Regarding claim 16, Jang discloses the controller is configured to activate a flow rate indicator, and also configured to provide the notification that the air or occlusion is detected to the user with a visual indicator; however, there is no motivation in the art of record to modify Jang so the controller is configured to activate the plurality of flow rate indicator elements simultaneously to provide the notification that the air or occlusion is detected to the user. The flow rate indicator of Jang can provide a notification of air or occlusion is detected, however, if the device of Jang were to be modified to include more than one flow rate indicator, they would not all simultaneously provide the notification of air or occlusion detection as claimed.
Claim 21 is allowed as being dependent on allowed claim 16.
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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/A.E.V./Examiner, Art Unit 3783
/TASNIM MEHJABIN AHMED/Primary Examiner, Art Unit 3783