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 3/26/2026. As directed by the amendment: Claims 1 and 15 have been amended. Thus, claims 1-2, 4, 6, and 8-16 are presently pending in this application.
Response to Argument
Applicant's arguments filed 3/26/2026 have been fully considered but they are not fully persuasive.
Regarding applicant’s argument regarding the independent claims on page 6-8:
Applicant argues that the prior art relied upon in the preceding office action does not teach the following limitations of the presently amended claims:
"wherein the ganged connection continuously connects the primary three-way valve and the secondary three-way valve"
In this regard, applicant particularly argues that because “Pretorius's cam operates by selectively engaging and disengaging individual valve components. To close a valve, the cam engages a ball 252, pressing it against a diaphragm 254 to seal the inlet and outlet. To open a valve, however, the cam must disengage from that valve's ball, 'Which releases the diaphragm 254 back to its repose position, thereby allowing fluid flow between the inlet 248 and the outlet 250." See Pretorius, paragraph [0048]. Thus, a valve in Pretorius is "open" only when the cam has released contact with it—the cam must physically withdraw from a valve component to permit that valve to function” and accordingly cannot be considered a ganged connection that "continuously connects" two valves.
However, Examiner notes that as demonstrated by Pretorius’ fig 3-4, when the cam 242 permits the ball-diaphragm structures to either return to its reposed “open” position, seen in fig 3 where cam 242 has “disengaged” from ball 252 substantially enough to permit diaphragm 254 to return to an open position, or be maintained in its engaged “closed” position, seen in fig 4 where cam 242 has “engaged” the ball 252 substantially enough to permit diaphragm 254 to move to a closed position, the cam 242 maintains a physical mechanical connection, therein a continuous connection, with the claimed valves in the manner that cam 242’s cam surface 247 is demonstrated as maintaining physical contact with the ball element 252.
Further, the aspects of Pretorius’ disclosure which applicant references in their arguments, particularly paragraph 47-48, are clear in that where they recite “movement of the first cam 242 in a first direction 256 causes the first cam 242 to engage the ball 252, which presses the ball 252 against the diaphragm 254 to close the inlet 248 and the outlet 250 of the first valve 220 or the second valve 222”, emphasis added, as well as reciting “movement of the first cam 242 in a second direction 258 opposite the first direction 256 causes the first cam 242 to disengage the ball 252, which releases the diaphragm 254 back to its repose position”, emphasis added, the disclosure is clear that the engagement/disengagement of cam 242 with the ball 252 only relates to the degree that the ball 252 presses against diaphragm 254 and is not so specific as to suggest, teach, nor disclose that the ball 252 no longer mechanically contacts/communicates with cam 242 and its cam surfaces 247. In fact, the illustrations of its invention, see fig 3-4, demonstrate that the mechanical contact/connection is maintained in both valve positions.
Accordingly, in the modification described below where the cam coordinates the opening and closing of a further number of valves, the cam likewise maintains a continuous mechanical connection between the claimed multitude of valves.
Accordingly, examiner's rejection as necessitated by the amendment, below, detailing the rejection of the claims in view of the prior art of record stands.
Regarding applicant’s argument regarding dependent claims on page 7-8:
Applicant argues that their preceding arguments render the independent claims allowable, and consequently likewise the dependent claims are allowable.
See examiner's rejection as necessitated by the amendment, below, denoting the prior art relied upon to teach/disclose the subject matter of the dependent claims.
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.
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 1-2, 6, 8-9, and 11-16 are rejected under 35 U.S.C. 103 as being unpatentable over US 20190336680 A1, henceforth written as Pretorius, in view of US 20160015872 A1, henceforth written as Luckemeyer, and further in view of WO 0249707 A2, henceforth written as Wex.
Regarding Claim 1,
Pretorius discloses:
A drug delivery system comprising:
(paragraph 73; microfluidic circuit 502 governs drug delivery for a medicament delivery device (not enumerated/illustrated) ; fig 17)
a delivery container including
(paragraph 73; housing (not enumerated/illustrated) of medicament delivery device (not enumerated/illustrated) )
a container body comprising an -- elastomeric pump adapted to accommodate a drug therein,
(paragraph 74; reservoir 512 is an elastomeric bladder containing drugs, such as insulin; fig 17)
an inlet port and an outlet port,
(paragraph 74; fill port 508, constitutes the inlet port, and the portion of flow path immediately downstream of filter 510 and upstream of flow path 504 and 506 bifurcation; fig 17)
the container body being constructed from a resilient material such that the container body is adapted to exert an urging force on the drug to expel the drug from the outlet port;
(paragraph 33+74; "during use [drug] is forced from the [reservoir 512] due to contraction of the elastomeric, therein resilient, bladder)
a supply line operably coupled to the outlet port to deliver the drug to a user;
(paragraph 74; cannula 518 delivers drug to the user; fig 17)
and a flow rate monitor operably coupled to at least one of the delivery container or the supply line,
(paragraph 79; bolus dose delivery system 500 monitors the rate at which bolus units are distributed over time, therein a flow rate monitor, and is fluidically coupled to reservoir 512 and cannula 518; fig 17-18)
the flow rate monitor comprising: a – controller--
(paragraph 79; valve actuator (not enumerated/illustrated), therein governing bolus dispensing, is in communication with a controller (not enumerated/illustrated) )
a fluid valve operably coupled to the -- controller,
(paragraph 75; valve sets 520 522; fig 18)
wherein the fluid valve comprises: a primary three-way valve including a primary valve inlet, a first primary valve outlet, and a second primary valve outlet; and
(see examiner's annotated fig 18 below; primary three-way valve comprises the portion of flow path 506 upstream of membrane 526, and valves 544 548; fig 18)
a secondary three-way valve including a first secondary valve inlet, a second secondary valve inlet, and a secondary valve outlet;
(see examiner's annotated fig 18 below; secondary three-way valve comprises the portion of flow path 506 downstream of membrane 526, and valves 546 550; fig 18)
wherein the primary three-way valve is ganged to the secondary three-way valve.
(fig 18 and paragraph 76-79 demonstrate the ganged nature of the claimed three-way valves in that they are operably coupled to be selectively switched between their open and closed states, particularly by an actuator in communication with a controller, therein governing and driving flow emptying and filling portions of chamber 524)
wherein the primary three-way valve is -- coupled by a ganged connection to the secondary three-way valve such that selective switching of the primary three-way valve between the first primary valve outlet and the second primary valve outlet causes selective switching of the secondary three-way valve between the first secondary valve inlet and the second secondary valve inlet via the ganged connection;
(paragraph 79; a single actuator (not enumerated/illustrated) in communication with a controller (not enumerated/illustrated) may control the selective switching operation of the valve sets, such that when valves 544 546 are opened the valves 548 550 are closed, and upon opening valves 548 550 the valves 544 546 are closed, thus switching the aforementioned valve states, results in a selective switching of the primary three-way valve between a first primary valve outlet, when valve 544 is open, and the second primary valve outlet, when valve 548 is open, and a likewise selective switching of the secondary three-way valve between the first secondary valve inlet, when valve 550 is open, and the second secondary valve inlet, when valve 546 is open, occurs; see examiner’s annotation of Pretorius’s figure 18)
wherein the ganged connection continuously connects the primary three-way valve and the secondary three-way valve;
(fig 3-4 demonstrate that cam 242 maintains a continuous mechanical connection with the valve closing/opening elements, ball 252 and diaphragm 254, in the manner that its cam surface 247 maintains physical mechanical contact with ball 252 when the ball 252 has permitted the diaphragm 254 to move to either its reposed/open position or its closed position.)
a diaphragm assembly in fluid communication with the fluid valve
(paragraph 75; bolus dose delivery system 500 includes flexible membrane 526 in fluid communication with valve sets 520 522; fig 18)
and being operably coupled to the -- controller,
(paragraph 79; valve actuator (not enumerated/illustrated) is in communication with a controller (not enumerated/illustrated) )
wherein the fluid valve, the diaphragm assembly, and the -- controller cooperate to regulate a flow rate of the drug,
(paragraph 79; valve sets 520 522, flexible membrane 526, and a controller (not enumerated/illustrated) work in concert to deliver the desired bolus dose)
wherein the diaphragm assembly comprises: a reservoir defining an internal volume,
(paragraph 75; bolus chamber 524 is formed as a fixed cavity 528; fig 18)
a first side port, and
(opening 540; fig 18)
a second side port; and
(opening 542; fig 18)
a diaphragm disposed within the internal volume of the reservoir
(membrane 526; fig 18)
between the first side port and the second side port to define a first cavity and a second cavity
(paragraph 75; first portion 532 and second portion 534 define the volume of the bolus chamber 524; fig 18)
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Examiner’s annotated figure 18
Pretorius discloses the elements of the present claim, as described above. Yet, its present embodiment is silent on:
wherein the primary three-way valve is mechanically coupled by a ganged connection to the secondary three-way valve such that selective switching of the primary valve and the secondary valve via the ganged connection occurs
However, Pretorius further teaches:
wherein the primary three-way valve is mechanically coupled by a ganged connection to the secondary three-way valve such that selective switching of the primary valve and the secondary valve via the ganged connection occurs
(the mechanism of action for the mechanically coupled ganged connection of multiple alternating valves is described in paragraph 47-50 and illustrated fig 3-8, button 240 moves in a first direction 256 such that a singular ball 252 associated with a first valve 220 is depressed by a first cam 242 to seal a diaphragm 254 governing the first valve 220 closed, while the first cam 242 has a cam profile 247 that simultaneously permits a second valve 222 to remain open by permitting another diaphragm 254 to repose against another ball 252, conversely the button 240 may be moved in a second direction 258 which has the opposite effect such that first cam 242 permits first valve 220's diaphragm 254 to repose against its ball 252, and first cam 242 depresses second valve 222's ball 252 against its diaphragm 254 to close the valve; valve 220 and 222 can be considered mechanical coupled by a ganged connection by the manner by which first cam 242 mechanical depresses a ball 252 against a diaphragm 252, or permits that diaphragm 254 to repose against that ball 252, associated with each valve 220 222 to govern opposing open/closed states of each valve 220 222; the first cam 242, having a shaped cam profile(s) 247 which actuates the valves, is considered to be the claimed ganged connection between the valves, and it may be considered mechanically coupled to the valves in the manner by which it mechanically acts upon each valve, thus mating/coupling with each valve’s associated ball, to regulate their opened/closed state)
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to implement the specific button cam structure actuating and alternating the states of multiple valves taught by the alternative embodiment of Pretorius to the generic button actuator of multiple alternating valves disclosed by the present embodiment of Pretorius, such that moving Pretorius’ button 240 in a first/second direction will alternatingly switch the claimed primary and secondary valves in the claimed manner, as a matter of applying a known technique for switching the state of multiple valves with a single actuator to a number of valves to be switched in a comparable manner and which are demonstrated by Pretorius as ready for such an improvement to achieve the predictable result of a drug delivery system which can switch the state of its valves for drug delivery by a single actuation of its actuator by a user or controller mechanism, see paragraph 48+79 of Pretorius and MPEP 2143.
Examiner notes for the sake of clarity that such a modification would involve Pretorius’s valves 544 546 548 550 being set in an opened or closed state by a ball 252 and diaphragm 254, corresponding one of valves 544 546 548 550, being depressed and/or being allowed to return to form by the movement of an actuator button 240 translating a first cam 242 to a certain position such that its cam profile(s) 247 interacts with each ball 252 to depress against diaphragm 254 and close the corresponding valve, or allow diaphragm 254 to return to form and open the corresponding valve.
The modified device of Pretorius discloses the elements of the present claim, as described above. Yet, it is silent on:
--a container body comprising a disposable elastomeric pump adapted to accommodate a drug therein, --
However, Wex teaches a fluid delivery pump and container:
a container body comprising a disposable elastomeric pump adapted to accommodate a drug therein,
(page 6 line 15 to page 7 line 3 and page 7 line 25-34; liquid pump 1 includes an elastomeric membrane 15, which works in concert with leaf spring 5 to pump liquid out of bag 8 and out of its outgoing line 10; page 4 line 17-29; these functional components of the pump 1 can be replaced individually or as a whole, therein disposable)
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to apply Wex's teachings of a liquid pump with replaceable components and pump driving mechanisms to Pretorius' reservoir 512 in order to advantageously arrive at a drug delivery system's pump which is suitable for long delivery times, by allowing high-wear components (i.e. elastomeric membranes, springs, etc.) to be replaced over time, see page 4 line 17-29 of Wex.
Pretorius in view of Wex discloses the elements of the present claim, as described above. Yet, the modified device is silent on:
-- the flow rate monitor comprising: a digital controller including software adapted to control operation thereof, a fluid valve operably coupled to the digital controller,--
However, Luckemeyer teaches a fluid delivery device:
the flow rate monitor comprising: a digital controller including software adapted to control operation thereof, a fluid valve operably coupled to the digital controller,
(paragraph 33-39, controller (not enumerated/illustrated) communicates with valves to open/close them at the bequest of signals sent to/received from an external user interface device, controlling a metered flow from the system)
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to apply Luckemeyer's teachings of a digital controller communicating with an external user interface teachings to the controller disclosed by Pretorius in order to advantageously arrive at an invention which can control the dispensation of fluid from the drug delivery system from an external environment, see paragraph 34-35 and 38 of Luckemeyer.
Pretorius in view of Wex and Luckemeyer discloses the elements of the present claim, as described above. Yet, the modified device is silent on:
--and an end of travel sensor configured to sense at least one directional limit of the diaphragm.
However, Luckemeyer teaches a fluid delivery device:
further comprising an end of travel sensor configured to sense at least one directional limit of the diaphragm.
(paragraph 36+77+84, a sensor (not enumerated/illustrated) which senses the rate of change of a measurand (i.e. pressure, capacitance, electromagnetism, light, electrical potential) and relates this change to a known fill rate of cartridge 112 and allows some determinations of its fill status to be determined, therein sensing whether the diaphragm 124 has met a directional limit indicating its dosing chamber 128 is filled; fig 8)
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate Luckemeyer's teachings of utilizing a sensor and controller processing of sensor data to detect when a dosing chamber has reached its dose capacity, as indicated by a diaphragm reaching a directional limit, to the drug delivery system of Pretorius, by disposing Luckemeyer’s pressure sensors on opposing sides of Pretorius’ diaphragm in system 500 for sensing a negative pressure when an opposing chamber is filling therein arriving at the claimed invention, in order to advantageously arrive at an invention which can detect when a dose of media is prepared and ready for dispensing from a cavity of the invention or if further filling of the cavity is necessitated to arrive at the desired dose, see paragraph 84 of Luckemeyer, therein improving the reliability of the invention to provide a required dose and consequently avoid risks associated with under/over delivery of media such as worsening condition and death.
Regarding Claim 2, the modified device of Pretorius in view of Wex and Luckemeyer discloses:
The drug delivery system of claim 1, wherein the digital controller is adapted to cause the flow rate monitor to actuate the fluid valve.
Examiner notes that in light of the modifications of Pretorius in view of Wex and Luckemeyer above, the valve sets 520 522 of Pretorius can have their states switched by the actuation of its actuator by Luckemeyer’s controller.
Regarding Claim 6, the modified device of Pretorius in view of Wex and Luckemeyer discloses:
The drug delivery system of claim 1, wherein the diaphragm is constructed from a resilient material.
Pretorius: (paragraph 75; membrane 526 is flexible, therein resilient)
Regarding Claim 8, the modified device of Pretorius in view of Wex and Luckemeyer teaches:
The drug delivery system of claim 1, wherein the at least one end of travel sensor comprises an optical sensor.
Luckemeyer: (paragraph 36; claimed travel sensor incorporated in the modification of Pretorius in view of Wex and Luckemeyer above may be an optical sensor)
Regarding Claim 9, the modified device of Pretorius in view of Wex and Luckemeyer teaches:
The drug delivery system of claim 1, wherein the at least one end of travel sensor comprises at least one of an electrical contact sensor or a capacitive sensor.
Luckemeyer: (paragraph 36; claimed travel sensor incorporated in the modification of Pretorius in view of Wex and Luckemeyer above may be a capacitive sensor)
Regarding Claim 11, the modified device of Pretorius in view of Wex and Luckemeyer teaches:
The drug delivery system of claim 1, wherein the at least one end of travel sensor comprises a pressure monitor.
Luckemeyer: (paragraph 36; claimed travel sensor, incorporated in the modification of Pretorius in view of Wex and Luckemeyer above, may be a pressure sensor)
Regarding Claim 12, the modified device of Pretorius in view of Wex and Luckemeyer teaches:
The drug delivery system of claim 1, wherein the flow rate monitor further comprises: 1) an interface coupled to the digital controller to receive at least one input; and
Luckemeyer: (paragraph 33-34, includes a user interface (not enumerated/illustrated) able to receive input from an external environment, which was incorporated in the modification of Pretorius in view of Wex and Luckemeyer in claim 1above )
2) a display coupled to the digital controller.
Luckemeyer: (paragraph 35, user interface (not enumerated/illustrated) may include one or more display screens)
Regarding Claim 13, the modified device of Pretorius in view of Wex and Luckemeyer teaches:
The drug delivery system of claim 1, further comprising an alarm operably coupled to the digital controller.
Luckemeyer: (paragraph 33+35+80+86, an alarm/audible indicator, already incorporated in the modification of Pretorius in view of Wex and Luckemeyer made in claim 1 above, may be coupled to controller for being detected by an operator and communicating different pieces of information about the device)
Regarding Claim 14,
The modified device of Pretorius in view of Luckemeyer and Wex discloses the elements of the present claim, as described above. Yet, its present embodiment is silent on:
The drug delivery system of claim 1, further comprising at least one of an air trap, a filter, or a flow restrictor, or a fluid path compliance member downstream of the flow controller.
However, Luckemeyer teaches a fluid delivery device:
further comprising at least one of a fluid path compliance member downstream of the flow controller.
(Luckemeyer: paragraph 28; cover 108 and dressing 102 provides a sealed therapeutic environment proximate to the tissue site 110, therein providing a fluid path compliance area downstream of a claimed flow controller; fig 1)
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate Luckemeyer's teachings of providing a cover and dressing to a tissue site to the portion of tubing immediately upstream of the supply line disclosed by Pretorius, Pretorius' cannula, in order to provide a sealed therapeutic environment which can mitigate any associated with the external environment (i.e. loss of sterility, infection, etc.), as well as providing means for removing exudates and other fluids from the tissue site, see paragraph 28 of Luckemeyer.
Regarding Claim 15,
Pretorius discloses:
A drug delivery system comprising:
(paragraph 73; microfluidic circuit 502 governs drug delivery for a medicament delivery device (not enumerated/illustrated) ; fig 17)
a delivery container including
(paragraph 73; housing (not enumerated/illustrated) of medicament delivery device (not enumerated/illustrated) )
a container body comprising a -- elastomeric pump adapted to accommodate a drug therein,
(paragraph 74; reservoir 512 is an elastomeric bladder containing drugs, such as insulin; fig 17)
an inlet port and an outlet port,
(paragraph 74; fill port 508, constitutes the inlet port, and the portion of flow path immediately downstream of filter 510 and upstream of flow path 504 and 506 bifurcation; fig 17)
the container body receiving a driving force that causes the container body to exert an urging force on the drug to expel the drug from the outlet port;
(paragraph 33+74; reservoir 512's elastomeric bladder receives a force contracting it, and therein expelling its drug contents)
a supply line operably coupled to the outlet port to deliver the drug to a user;
(paragraph 74; cannula 518 delivers drug to the user; fig 17)
and a flow rate monitor operably coupled to at least one of the delivery container or the supply line,
(paragraph 79; bolus dose delivery system 500 monitors the rate at which bolus units are distributed over time, therein a flow rate monitor, and is fluidically coupled to reservoir 512 and cannula 518; fig 17-18)
the flow rate monitor comprising: a -- controller --
(paragraph 79; valve actuator (not enumerated/illustrated), therein governing bolus dispensing, is in communication with a controller (not enumerated/illustrated) )
a fluid valve operably coupled to the -- controller,
(paragraph 75; valve sets 520 522; fig 18)
the fluid valve comprising: 1) a primary three-way valve including a primary valve inlet, a first primary valve outlet, and a second primary valve outlet;
(see examiner's annotated fig 18 above; primary three-way valve comprises the portion of flow path 506 upstream of membrane 526, and valves 544 548; fig 18)
and 2) a secondary three-way valve including a first secondary valve inlet, a second secondary valve inlet, and a secondary valve outlet,
(see examiner's annotated fig 18 above; secondary three-way valve comprises the portion of flow path 506 downstream of membrane 526, and valves 546 550; fig 18)
wherein the primary three-way valve is -- coupled by a ganged connection to the secondary three-way valve such that selective switching of the primary three-way valve between the first primary valve outlet and the second primary valve outlet causes selective switching of the secondary three-way valve between the first secondary valve inlet and the second secondary valve inlet via the ganged connection;
(paragraph 79; a single actuator (not enumerated/illustrated) in communication with a controller (not enumerated/illustrated) may control the selective switching operation of the valve sets, such that when valves 544 546 are opened the valves 548 550 are closed, and upon opening valves 548 550 the valves 544 546 are closed, thus switching the aforementioned valve states, results in a selective switching of the primary three-way valve between a first primary valve outlet, when valve 544 is open, and the second primary valve outlet, when valve 548 is open, and a likewise selective switching of the secondary three-way valve between the first secondary valve inlet, when valve 550 is open, and the second secondary valve inlet, when valve 546 is open, occurs; see examiner’s annotation of Pretorius’s figure 18)
wherein the ganged connection continuously connects the primary three-way valve and the secondary three-way valve;
(fig 3-4 demonstrate that cam 242 maintains a continuous mechanical connection with the valve closing/opening elements, ball 252 and diaphragm 254, in the manner that its cam surface 247 maintains physical mechanical contact with ball 252 when the ball 252 has permitted the diaphragm 254 to move to either its reposed/open position or its closed position.)
a diaphragm assembly in fluid communication with the fluid valve
(paragraph 75; bolus dose delivery system 500 includes flexible membrane 526 in fluid communication with valve sets 520 522; fig 18)
and being operably coupled to the -- controller,
(paragraph 79; valve actuator (not enumerated/illustrated) is in communication with a controller (not enumerated/illustrated) )
the diaphragm assembly including: 1) a reservoir defining an internal volume and having a first side port and a second side port;
(paragraph 75; bolus chamber 524 is formed as a fixed cavity 528, with openings 540 542; fig 18)
and 2) a diaphragm disposed within the internal volume
(membrane 526; fig 18)
wherein the second primary valve outlet of the primary three-way valve and the first secondary valve inlet of the secondary three-way valve are fluidly coupled with the first side port of the reservoir and the first primary valve outlet of the primary three-way valve and the second secondary valve inlet of the secondary three-way valve are fluidly coupled with the second side port of the reservoir,
(see examiner's annotated figure 18 for notation of the claimed valve elements, and Pretorius' fig 18, demonstrating the fluidic communication of openings 540 542 with the claimed corresponding valve elements )
wherein the fluid valve, the diaphragm assembly, and the -- controller cooperate to regulate a flow rate of the drug.
(paragraph 79; valve sets 520 522, flexible membrane 526, and a controller (not enumerated/illustrated) work in concert to deliver the desired bolus dose)
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Examiner’s annotated figure 18
Pretorius discloses the elements of the present claim, as described above. Yet, its present embodiment is silent on:
wherein the primary three-way valve is mechanically coupled by a ganged connection to the secondary three-way valve such that selective switching of the primary valve and the secondary valve via the ganged connection occurs
However, Pretorius further teaches:
wherein the primary three-way valve is mechanically coupled by a ganged connection to the secondary three-way valve such that selective switching of the primary valve and the secondary valve via the ganged connection occurs
(the mechanism of action for the mechanically coupled ganged connection of multiple alternating valves is described in paragraph 47-50 and illustrated fig 3-8, button 240 moves in a first direction 256 such that a singular ball 252 associated with a first valve 220 is depressed by a first cam 242 to seal a diaphragm 254 governing the first valve 220 closed, while the first cam 242 has a cam profile 247 that simultaneously permits a second valve 222 to remain open by permitting another diaphragm 254 to repose against another ball 252, conversely the button 240 may be moved in a second direction 258 which has the opposite effect such that first cam 242 permits first valve 220's diaphragm 254 to repose against its ball 252, and first cam 242 depresses second valve 222's ball 252 against its diaphragm 254 to close the valve; valve 220 and 222 can be considered mechanical coupled by a ganged connection by the manner by which first cam 242 mechanical depresses a ball 252 against a diaphragm 252, or permits that diaphragm 254 to repose against that ball 252, associated with each valve 220 222 to govern opposing open/closed states of each valve 220 222; the first cam 242, having a shaped cam profile(s) 247 which actuates the valves, is considered to be the claimed ganged connection between the valves, and it may be considered mechanically coupled to the valves in the manner by which it mechanically acts upon each valve, thus mating/coupling with each valve’s associated ball, to regulate their opened/closed state)
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to implement the specific button cam structure actuating and alternating the states of multiple valves taught by the alternative embodiment of Pretorius to the generic button actuator of multiple alternating valves disclosed by the present embodiment of Pretorius, such that moving Pretorius’ button 240 in a first/second direction will alternatingly switch the claimed primary and secondary valves in the claimed manner, as a matter of applying a known technique for switching the state of multiple valves with a single actuator to a number of valves to be switched in a comparable manner and which are demonstrated by Pretorius as ready for such an improvement to achieve the predictable result of a drug delivery system which can switch the state of its valves for drug delivery by a single actuation of its actuator by a user or controller mechanism, see paragraph 48+79 of Pretorius and MPEP 2143.
Examiner notes for the sake of clarity that such a modification would involve Pretorius’s valves 544 546 548 550 being set in an opened or closed state by a ball 252 and diaphragm 254, corresponding one of valves 544 546 548 550, being depressed and/or being allowed to return to form by the movement of an actuator button 240 translating a first cam 242 to a certain position such that its cam profile(s) 247 interacts with each ball 252 to depress against diaphragm 254 and close the corresponding valve, or allow diaphragm 254 to return to form and open the corresponding valve.
The modified device of Pretorius discloses the elements of the present claim, as described above. Yet, it is silent on:
--a container body comprising a disposable elastomeric pump adapted to accommodate a drug therein, --
However, Wex teaches a fluid delivery pump and container:
a container body comprising a disposable elastomeric pump adapted to accommodate a drug therein,
(page 6 line 15 to page 7 line 3 and page 7 line 25-34; liquid pump 1 includes an elastomeric membrane 15, which works in concert with leaf spring 5 to pump liquid out of bag 8 and out of its outgoing line 10; page 4 line 17-29; these functional components of the pump 1 can be replaced individually or as a whole, therein disposable)
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to apply Wex's teachings of a liquid pump with replaceable components and pump driving mechanisms to Pretorius' reservoir 512 in order to advantageously arrive at a drug delivery system's pump which is suitable for long delivery times, by allowing high-wear components (i.e. elastomeric membranes, springs, etc.) to be replaced over time, see page 4 line 17-29 of Wex.
Pretorius in view of Wex discloses the elements of the present claim, as described above. Yet, the modified device is silent on:
-- the flow rate monitor comprising: a digital controller including software adapted to control operation thereof, a fluid valve operably coupled to the digital controller,--
However, Luckemeyer teaches a fluid delivery device:
the flow rate monitor comprising: a digital controller including software adapted to control operation thereof, a fluid valve operably coupled to the digital controller,
(paragraph 33-39, controller (not enumerated/illustrated) communicates with valves to open/close them at the bequest of signals sent to/received from an external user interface device, controlling a metered flow from the system)
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to apply Luckemeyer's teachings of a digital controller communicating with an external user interface teachings to the controller disclosed by Pretorius in order to advantageously arrive at an invention which can control the dispensation of fluid from the drug delivery system from an external environment, see paragraph 34-35 and 38 of Luckemeyer.
Pretorius in view of Wex and Luckemeyer discloses the elements of the present claim, as described above. Yet, the modified device is silent on:
wherein the primary three-way valve is positioned adjacent to the secondary three-way valve such that the primary three-way valve is physically ganged to the secondary three-way valve via a movable linkaqe
Notably Pretorius did disclose in paragraph 79 that a physical actuator, such a button, in communication with a controller, may control operation of the valve sets.
However, Pretorius teaches an alternative embodiment of fluid delivery system with physically ganged valves wherein:
wherein the primary valve is positioned adjacent to the secondary valve such that the primary valve is physically ganged to the secondary valve via a movable linkaqe such that selective switching of the valve also causes selective switching of the secondary valve,
(paragraph 49; valve 220 and valve 222 are physically ganged together by actuation of button 240 triggering the selective switching of the valves by the interaction of moving cam elements 242 246 248, latch 238, and piston 234; fig 6-9)
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to substitute the button actuator valve switching structure taught by Pretorius’ alternative embodiment for the generic button actuator of the three-way valves of the modified device of Pretorius in view of Wex and Luckemeyer, therein arriving at the claimed invention by applying a known technique for switching valves and achieving the predictable result of a drug delivery system which can switch its valves to drive a filling/emptying of a drug containing cavity.
Regarding Claim 16, the modified device of Pretorius in view of Wex and Luckemeyer teaches:
The drug delivery system of claim 15, wherein the driving force is generated by at least one of a spring
Wex: (page 7 line 25-34; leaf spring 5 drives against membrane to dispense liquid)
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Pretorius in view of Luckemeyer and Wex, and further in view of US 4900322 A, henceforth written as Adams.
Regarding Claim 4,
Pretorius in view of Luckemeyer and Wex discloses the elements of the present claim, as described above. Yet, its present embodiment is silent on:
The drug delivery system of claim 1, wherein the fluid valve comprises a four-way valve.
Notably, Pretorius does disclose in paragraph 74 that its circuit 502 may include additional components, such as reservoir 512 for instance, to deliver one or more medicaments or combinations thereof.
However, Adams teaches a fluid management device:
wherein the fluid valve comprises a four-way valve.
(valve 10 is a four way valve for transferring media between multiple fluid containers and fluid dispensers; fig 7)
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate Adams teachings of a four-way valve governing flow between fluid containers and fluid measurers/dispensers to the drug delivery system disclosed by Pretorius in order to advantageously provide a drug delivery system which can execute a therapeutic regiment comprising dosing multiple medicaments, see paragraph 74 of Pretorius.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Pretorius in view of Luckemeyer and Wex, and further in view of US 20050131332 A1, henceforth written as Kelly.
Regarding Claim 10,
Pretorius in view of Luckemeyer and Wex discloses the elements of the present claim, as described above. Yet, its present embodiment is silent on:
The drug delivery system of claim 7, wherein the at least one end of travel sensor comprises a hall effect sensor.
Notably, Luckemeyer does teach in paragraph 36 that its claimed travel sensor, as discussed in claim 7 above, may be an electromagnetic sensor.
However, Kelly teaches a fluid management device:
wherein the at least one end of travel sensor comprises a hall effect sensor
(paragraph 266; sensors 376 may measure the hall effect from the separator 366a traveling from end 362a to end 364b, therein a travel sensor; fig 28)
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to substitute the travel sensor taught by Pretorius in view of Luckemeyer with the hall effect sensor taught by Kelly as they are art recognized equivalents known for the same purpose of measuring the travel cycle of an element, see MPEP 2144.06(II), paragraph 266 of Kelly, and paragraph 36 of Luckemeyer.
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 FORREST DIPERT whose telephone number is (703)756-1704. The examiner can normally be reached M-F 8:30am-5pm eastern.
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/FORREST B DIPERT/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
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