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 .
Status of the Claims
Claims 1-20 are currently pending. Claims 1, 11, 13, and 20 are currently amended. Claims 1-20 are currently rejected.
Response to Arguments
Applicant's arguments filed 10/01/2025 have been fully considered but they are not persuasive. New grounds of rejection, required by Applicant’s amendments, are applied to the amended claims below.
Examiner acknowledges that Applicant’s amendments to claim 13 overcome the previous objection, which is thus not extended to claim 13 as currently amended. Additionally, the corrected drawing sheets for figs. 5A, 5B, 6, 7, 8, and 9 rectify the previous legibility issue and are appreciated.
Applicant argues that Wyeth and Estes do not disclose a per-cycle baseline pressure when there is isolation between chambers. However, Wyeth discloses isolation of chambers at the beginning of the cycle (see fig. 4a) and Estes does disclose a per-cycle baseline pressure (see Estes fig. 12, box 610, at the beginning of the cycle, establishes a baseline pressure). See rejections of amended independent claim 1, 11, and 20 below for a full outline of how Wyeth modified by Wyeth and Estes disclose all limitations of the independent claim as written. Examiner notes that no specific duration/definition is given to a “cycle”, and thus a cycle may be the entire life of a cartridge, or an entire dialysis treatment, or similar.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., “Once the chamber disconnects, the baseline is reset and a new baseline is recorded for the next cycle.”, see Remarks, page 13, Technical Advantages of the Claimed Invention, paragraph 2) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation "the baseline" in line 14. There is insufficient antecedent basis for this limitation in the claim. The limitation “a baseline downstream pressure” is introduced on line 11, but since the terminology is inconsistent, it is unclear whether “the baseline” is meant to refer back to the baseline pressure previously introduced, or to a different baseline value/feature/condition. For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claim 3 recites the limitation "a baseline pressure" in line 6, and “the baseline pressure” in lines 9-10. The limitation “a baseline downstream pressure” is introduced on line 11 of claim 1, from which claim 3 depends. It is unclear whether the instance of “a baseline pressure” in the dependent claim is meant to introduce a new limitation (in which case the naming convention should be altered to distinguish the limitations) or refer back to the same limitation earlier introduced (in which case the article should be changed to “the”). For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claim 11 recites the limitation "the baseline" in lines 12-14. There is insufficient antecedent basis for this limitation in the claim. The limitation “a baseline downstream pressure” is introduced on line 11, but since the terminology is inconsistent, it is unclear whether “the baseline” is meant to refer back to the baseline pressure previously introduced, or to a different baseline value/feature/condition. For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claim 13 recites the limitation "a baseline pressure" in line 6, and “the baseline pressure” in line 9. The limitation “a baseline downstream pressure” is introduced on line 11 of claim 11. It is unclear whether the instance of “a baseline pressure” in the dependent claim is meant to introduce a new limitation (in which case the naming convention should be altered to distinguish the limitations) or refer back to the same limitation earlier introduced (in which case the article should be changed to “the”). For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claim 20 recites the limitation "the baseline" in lines 15-16. There is insufficient antecedent basis for this limitation in the claim. The limitation “a baseline downstream pressure” is introduced on line 13, but since the terminology is inconsistent, it is unclear whether “the baseline” is meant to refer back to the baseline pressure previously introduced, or to a different baseline value/feature/condition. For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claims 2-10 and 12-19 are rejected at least for depending upon a claim rejected under 112b above, since dependent claims inherit the deficiencies of those claims from which they depend.
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.
Claim(s) 1-5, 7, 11-15, 17, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wyeth et al (US 20190262526 A1; hereafter Wyeth) in view of Wyeth and Estes et al (US 20140276536 A1; hereafter Estes).
Regarding claim 1, Wyeth discloses a drug delivery device (peritoneal dialysis fluid proportioner/cycler 400, fig. 4K, [0109]), comprising: a fluid pathway (see fig. 4K) including a reservoir (water purifier 420, fig. 4K, [0112] The water purifier 420 may be a purifier or any source of sterile and purified water including a pre-sterilized container of water or multiple containers.), a pump (pump and valve network 416 and mixing container 406 , fig. 4A, fig. 4K, [0110] pump and valve network 416 includes a pump) downstream of the reservoir (see fig. 4K, note [0112] pump and valve network 416 has a purified water line 431 for receiving water), and a fluid line (line 450, fig. 4K) downstream of the pump (416/406), wherein the reservoir (water purifier 420) is configured to receive a fluid (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.; see fig. 4K which shows water linked to the water purifier, and see [0112]), and wherein the pump (416/406) is configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to deliver the fluid from the reservoir (420) to the fluid line (450) ([0110] pump and valve network 416 is effective to convey fluid between selected lines 442, 444, 446, 448, 450 and 418 responsively to control signals from the controller 410; [0112] fluid circuit with pump and valve network 416 also has a purified water line 431 for receiving water.);
a pressure sensor (pressure sensor 414, fig. 4K, [0109] the controller receives signals from distal and proximal pressure sensors 413 and 414 on a fill/drain line 450) configured to measure a pressure in the fluid pathway downstream of the pump (see fig. 4K); and
a controller (controller 410, fig. 4K, [0125]) programmed and/or configured to:
receive, from the pressure sensor (pressure sensor 414), the pressure measured in the fluid pathway (fig. 4K) downstream of the pump (416/406) as the fluid is delivered to the fluid line (450) ([0109] the controller receives signals from distal and proximal pressure sensors 413 and 414 on a fill/drain line 450);
record, at the beginning of each delivery cycle (pressure sensor 414, fig. 4A, [0109]), while the dosing chamber (mixing container 406) is fluidically isolated from the fluid line (fill/drain line 450, fig. 4A) (note that fig. 4A and fig. 4B shows the system prior to pumping or the connection of dosing chamber 406 with fill/drain line 450 shown in fig. 4K), a downstream pressure from the pressure sensor ([0109] The controller applies control signals to a fluid conveyer and valve network 416 and a water purifier 420 and receives signals from distal and proximal pressure sensors 413 and 414, respectively, on a fill/drain line 450 which may be in accord with foregoing embodiments.).
Wyeth, as described in reference to figures 4A to 4L, is silent to the controller being a microcontroller.
A second embodiment of Wyeth teaches a microcontroller ([0550] notes that embodiments of the method and system may be implemented using, among other listed options, a programmed microcontroller or a computer program product (software program stored on a non-transitory computer readable medium).).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to use a microcontroller as taught by a second embodiment of Wyeth with the device of Wyeth of figures 4A-4L, since Wyeth [0550] teaches that a microcontroller may be used with the devices taught by Wyeth. This would have been a simple substitution with components known in the art and would have produced predictable results.
Wyeth is silent to the microcontroller using the pressure to determine the presence of a gas bubble and providing an indication associated with the determination.
Estes, in the art of infusion pumps and methods, teaches:
record, at the beginning of each delivery cycle (see delivery cycle/method 600 in fig. 12; [0082] In some implementations, the baseline ambient air pressure can be the initial air pressure measured by the pressure sensor 250 at the time that the medicine cartridge 120 is installed into the pump device 100, and the pump device 100 is coupled to the controller device 200), a baseline pressure from the pressure sensor (see step 610 in fig. 12, “Establish a baseline ambient pressure”);
determine, during the delivery cycle (see fig. 12, see box 620, “Detect an ambient pressure change event”), based on the pressure measured in the fluid pathway downstream of the pump (pump device 100, fig. 1, [0090]) as the fluid is delivered to the fluid line (flexible tube 72, fig. 1, [0090]) and relative to the baseline (see 112b interpretation above), whether the fluid delivered to the fluid line includes a gas bubble ([0082]-[0083] pressure sensor 250 measures ambient air pressure, thus pressure measured in the fluid pathway downstream of the pump device 100 of the infusion pump system 10, and compares the measured value to stored threshold limit values; see fig. 1; [0090] a detected ambient pressure drop may indicate the presence of a gas bubble); and
control an output device (display 222, fig. 1, [0090]) to provide an indication associated with the determination of whether the fluid delivered to the fluid line includes a gas bubble ([0090] the controller device 200 can output instructions to the user using the display 222 (e.g., refer to fig. 1). For example, in response to a detected ambient pressure drop the user may be provided with instructions to inspect the flexible tube 72 of the infusion set 70 to check if any bubbles are present).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to include the determination and control/indication steps taught by Estes with the microcontroller of Wyeth since both references deal with drug delivery systems and Wyeth already discloses a pressure sensor in communication with a controller, and based on the pressure measured in the fluid pathway downstream of the pump before fluidically connecting the dosing chamber with the fluid line (as taught by Wyeth above), a baseline pressure as taught by Estes since this would allow immediate monitoring of pressure changes over time and thus facilitate bubble sensing. One would have been motivated to make the modification because, as noted by Estes [0090], bubble formation may lead to unintentional delivery of additional medicine to user, so it would be beneficial to track possible bubble formation events. Since bubbles in fluid delivery to patients can be dangerous, it would be beneficial to have warning as early as possible if there were to be a bubble incident.
Regarding claim 2, Wyeth modified by Wyeth ([0550]) and Estes discloses the drug delivery device of claim 1, as described above. Wyeth further discloses wherein the pump (416/406) includes a dosing chamber (mixing chamber 406, fig. 4K, [0111]), wherein the pump is configured to cyclically (i) pump the reservoir (water purifier 420, fig. 4C) with the dosing chamber (mixing container 406, fig. 4C) in fluid communication with the reservoir and not in fluid communication with the fluid line (see fig. 4C where arrows indicate flow path, [0116] controller 410 generates a command to flow purified water from the water purifier 420 to the mixing container 406) and (ii) fluidically connect the dosing chamber (406) with the fluid line (fill/drain line 450, fig. 4K), and wherein the fluid is delivered to the fluid line when the dosing chamber is fluidically connected with the fluid line ([0125] the contents of the mixing container 406 may be conveyed as illustrated in fig. 4K to the patient. Here the controller 410 has configured the fluid circuit with pump and valve network 416 to flow fluid to a patient 412).
Regarding claim 3, Wyeth modified by Wyeth and Estes disclose the drug delivery device of claim 2, as described above, including wherein the microcontroller is further programmed and/or configured to:
receive, from the pressure sensor (pressure sensor 414, fig. 4A, [0109]), a pressure measured in the fluid pathway downstream of the pump (pressure sensor 414, fig. 4A, [0109]) before fluidically connecting the dosing chamber (mixing container 406) with the fluid line (fill/drain line 450, fig. 4A) ([0109] The controller applies control signals to a fluid conveyer and valve network 416 and a water purifier 420 and receives signals from distal and proximal pressure sensors 413 and 414, respectively, on a fill/drain line 450 which may be in accord with foregoing embodiments. ; note that fig. 4A shows the system prior to pumping or the connection of dosing chamber 406 with fill/drain line 450 shown in fig. 4K); and
Wyeth is silent to determining a baseline pressure and determining the presence of a gas bubble based on the measured pressure and baseline pressure.
Estes, in the art of an infusion pumps and methods, further teaches determining a baseline pressure (see 112b interpretation above) ([0082] the method 600 may include operation 610, in which a baseline ambient air pressure is established as the initial pressure measured by the pressure sensor 250), and determining whether the fluid delivered to the fluid line includes a gas bubble based on the pressure measured in the fluid pathway downstream of the pump as the fluid is delivered to the fluid line and the baseline pressure ([0090] the controller device 200 can output instructions to the user using the display 222 (e.g., refer to fig. 1). For example, in response to a detected ambient pressure drop the user may be provided with instructions to inspect the flexible tube 72 of the infusion set 70 to check if any bubbles are present).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the device of claim 1 to have the microcontroller of claim 1 (see claim 1) to be further programmed and/or configured to determine, based on the pressure measured in the fluid pathway downstream of the pump (taught by Wyeth in claim 1) before fluidically connecting the dosing chamber with the fluid line, a baseline pressure as taught by Estes since this would allow immediate monitoring of pressure changes over time and thus facilitate bubble sensing. One would have been motivated to make the modification because bubbles in fluid delivery to patients can be dangerous, so it would be beneficial to have warning as early as possible if there were to be a bubble incident.
Regarding claim 4, Wyeth modified by Wyeth ([0550]) and Estes discloses the drug delivery device of claim 1, as described above, including wherein the microcontroller (Wyeth: controller 410, fig. 4K, [0125]; [0550] a programmed microcontroller may be used) is programmed and/or configured to determine whether the fluid delivered to the fluid line includes a gas bubble by:
comparing the pressure measured in the fluid pathway downstream of the pump (Wyeth: 416/406, fig. 4K, [0110]; Estes: pump device 100, fig. 1, [0090]) as the fluid is delivered to the fluid line (Wyeth: fill/drain line 450, fig. 4K, [0109]; Estes: flexible tube 72, fig. 1, [0090]) to a threshold pressure (Estes: [0083] measured air pressure values can be compared to threshold limit values that have been programmed and stored in the controller device 200); and
in response to the pressure measured in the fluid pathway downstream of the pump as the fluid is delivered to the fluid line satisfying the threshold pressure, determining that the fluid delivered to the fluid line includes a gas bubble (Wyeth: [0090] controller device 200 can alert user that bubble is present if a significant pressure decrease is sensed).
Regarding claim 5, Wyeth modified by Wyeth ([0550]) and Estes discloses the drug delivery device of claim 1, as described above, including wherein the microcontroller (Wyeth: controller 410, fig. 4K, [0125]; [0550] a programmed microcontroller may be used) is programmed and/or configured to determine whether the fluid delivered to the fluid line includes a gas bubble by:
determining, based on the pressure measured in the fluid pathway downstream (see Wyeth fig. 4K, note that the pressure sensor 414 is downstream of the pump and valve network 416) of the pump (Wyeth: 416/406, fig. 4K, [0110]; Estes: pump device 100, fig. 1, [0090]) as the fluid is delivered to the fluid line (Wyeth: fill/drain line 450, fig. 4K, [0109]; Estes: flexible tube 72, fig. 1, [0090]),
comparing the pressure (see 103 below for rate of change rationale) as the fluid is delivered to the fluid line to a threshold pressure (see 103 below for rate of change rationale) (Estes: [0083] measured air pressure values can be compared to threshold limit values that have been programmed and stored in the controller device 200); and
in response to the pressure (see 103 below for rate of change rationale) as the fluid is delivered to the fluid line satisfying the threshold pressure (see 103 below for rate of change rationale), determine that the fluid delivered to the fluid line includes a gas bubble (Wyeth: [0090] controller device 200 can alert user that bubble is present if a significant pressure decrease is sensed).
Wyeth, Wyeth [0550], and Estes are silent to determining a rate of change and using the rate of change of the pressure instead of the pressure.
Wyeth [0288] teaches using a rate of change of pressure in place of an absolute pressure ([0288] Note that instead of an absolute (gauge or absolute pressure in absolute terms) pressure, the controller 807 at S404A may respond to a predefined rate of change of pressure or a predefined total pressure change over a predefined interval of time.)
Thus, the device as further modified by Wyeth [0288] discloses determining, based on the pressure measured in the fluid pathway downstream (see Wyeth fig. 4K, note that the pressure sensor 414 is downstream of the pump and valve network 416) of the pump (Wyeth: 416/406, fig. 4K, [0110]; Estes: pump device 100, fig. 1, [0090]) as the fluid is delivered to the fluid line (Wyeth: fill/drain line 450, fig. 4K, [0109]; Estes: flexible tube 72, fig. 1, [0090]), a rate of change (Wyeth [0288]: rate of change of pressure may be used instead of pressure) associated with the pressure measured in the fluid pathway downstream of the pump as the fluid is delivered to the fluid line (Wyeth as shown in fig. 4K, see noted elements above).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to the microcontroller of Wyeth modified by Wyeth [0550] and Estes to use the rate of change of the pressure instead of the pressure itself, since Wyeth [0288] teaches that a controller may respond to a rate of change of pressure instead of a pressure. Thus, using the rate of change of pressure instead of the pressure itself would be a simple substitution of known alternatives in the art and produce predictable results. One would have been motivated to make the modification because monitoring the pressure related to time may provide a better indication of when sudden changes may occur that would be likely to impact the device.
Regarding claim 7, Wyeth modified by Wyeth ([0550]) and Estes discloses the drug delivery device of claim 1, as described above, including wherein the microcontroller (Wyeth: controller 410, fig. 4K, [0125]; [0550] a programmed microcontroller may be used) is programmed and/or configured to determine whether the fluid delivered to the fluid line includes a gas bubble by:
comparing the pressure (see 103 rationale below variation) to a threshold pressure (see rationale for variation below) (Estes: [0083] measured air pressure values can be compared to threshold limit values that have been programmed and stored in the controller device 200); and
in response to the pressure (see 103 rationale below for variation) satisfying the threshold pressure (see 103 rationale below for variation), determining that the fluid delivered to the fluid line during the period of time includes a gas bubble (Wyeth: [0090] controller device 200 can alert user that bubble is present if a significant pressure decrease is sensed).
Wyeth, Wyeth [0550], and Estes are silent to determining a rate of change and using the rate of change of the pressure instead of the pressure.
Wyeth [0288] teaches using variation in the pressure over a period of time (a predefined total pressure change over a predefined interval of time, noted in [0288]) in place of an absolute pressure ([0288] Note that instead of an absolute (gauge or absolute pressure in absolute terms) pressure, the controller 807 at S404A may respond to a predefined rate of change of pressure or a predefined total pressure change over a predefined interval of time.)
Thus, the device as further modified by Wyeth [0288] discloses determining, based on the pressure measured in the fluid pathway downstream (see Wyeth fig. 4K, note that the pressure sensor 414 is downstream of the pump and valve network 416) of the pump (Wyeth: 416/406, fig. 4K, [0110]; Estes: pump device 100, fig. 1, [0090]) as the fluid is delivered to the fluid line (Wyeth: fill/drain line 450, fig. 4K, [0109]; Estes: flexible tube 72, fig. 1, [0090]), a variation in the pressure over a period of time (Wyeth [0288] a predefined total pressure change over a predefined interval of time).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to the microcontroller of Wyeth modified by Wyeth [0550] and Estes to use the variation in the pressure over a period of time instead of the pressure itself, since Wyeth [0288] teaches that a controller may respond to a rate of change of pressure instead of a pressure. Thus, using the variation in the pressure over a period of time instead of the pressure itself would be a simple substitution of known alternatives in the art and produce predictable results. One would have been motivated to make the modification because monitoring the pressure related to time may provide a better indication of when sudden changes may occur that would be likely to impact the device.
Regarding claim 11, Wyeth discloses a method for pressure sensor based gas bubble detection for a drug delivery device (peritoneal dialysis fluid proportioner/cycler 400, fig. 4K, [0109]) comprising a fluid pathway (see fig. 4K) including a reservoir (water purifier 420, fig. 4K, [0112] The water purifier 420 may be a purifier or any source of sterile and purified water including a pre-sterilized container of water or multiple containers.) configured to receive a fluid (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.; see fig. 4K which shows water linked to the water purifier, and see [0112]), a pump (pump and valve network 416 and mixing container 406, fig. 4A) downstream of the reservoir (see fig. 4K, note [0112] pump and valve network 416 has a purified water line 431 for receiving water), and a fluid line (line 450, fig. 4K) downstream of the pump (416/406) (see fig. 4K, note that fill/drain line 450 is nearest to patient/outlet), the method comprising:
delivering, with the pump (416/406), the fluid from the reservoir (water purifier 420) to the fluid line (fill/drain line 450, fig. 4K, [0150]) ([0150] water may be pumped into the mixing container and then into the fill/drain line 450);
measuring, with a pressure sensor (pressure sensor 414), a pressure in the fluid pathway downstream (see fig. 4K) of the pump (416/406) as the fluid is delivered to the fluid line (450) ([0109] the controller receives signals from distal and proximal pressure sensors 413 and 414 on a fill/drain line 450);
receiving, with a controller (controller 410, fig. 4K, [0125]), the pressure measured in the fluid pathway downstream of the pump as the fluid is delivered to the fluid line ([0109] the controller receives signals from distal and proximal pressure sensors 413 and 414 on a fill/drain line 450);
record, at the beginning of each delivery cycle (pressure sensor 414, fig. 4A, [0109]), while the dosing chamber (mixing container 406) is fluidically isolated from the fluid line (fill/drain line 450, fig. 4A) (note that fig. 4A and fig. 4B shows the system prior to pumping or the connection of dosing chamber 406 with fill/drain line 450 shown in fig. 4K), a downstream pressure from the pressure sensor ([0109] The controller applies control signals to a fluid conveyer and valve network 416 and a water purifier 420 and receives signals from distal and proximal pressure sensors 413 and 414, respectively, on a fill/drain line 450 which may be in accord with foregoing embodiments.).
Wyeth, as described in reference to figures 4A to 4L, is silent to the controller being a microcontroller.
A second embodiment of Wyeth teaches a microcontroller ([0550] notes that embodiments of the method and system may be implemented using, among other listed options, a programmed microcontroller or a computer program product (software program stored on a non-transitory computer readable medium).).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to use a microcontroller as taught by a second embodiment of Wyeth with the device of Wyeth of figures 4A-4L, since Wyeth [0550] teaches that a microcontroller may be used with the devices taught by Wyeth. This would have been a simple substitution with components known in the art and would have produced predictable results.
Wyeth is silent to the microcontroller using the pressure to determine the presence of a gas bubble and providing an indication associated with the determination.
Estes, in the art of an infusion pumps and methods, teaches
recording, at the beginning of each delivery cycle (see delivery cycle/method 600 in fig. 12; [0082] In some implementations, the baseline ambient air pressure can be the initial air pressure measured by the pressure sensor 250 at the time that the medicine cartridge 120 is installed into the pump device 100, and the pump device 100 is coupled to the controller device 200), a baseline pressure from the pressure sensor (see step 610 in fig. 12, “Establish a baseline ambient pressure”);
determining, during the delivery cycle (see fig. 12, see box 620, “Detect an ambient pressure change event”), based on the pressure measured in the fluid pathway downstream of the pump (pump device 100, fig. 1, [0090]) as the fluid is delivered to the fluid line (flexible tube 72, fig. 1, [0090]) and relative to the baseline (See 112b interpretation above), whether the fluid delivered to the fluid line includes a gas bubble ([0083] pressure sensor 250 measures ambient air pressure, thus pressure measured in the fluid pathway downstream of the pump device 100 of the infusion pump system 10, and compares the measured value to stored threshold limit values; see fig. 1; [0090] a detected ambient pressure drop may indicate the presence of a gas bubble); and
controlling, an output device (display 222, fig. 1, [0090]) to provide an indication associated with the determination of whether the fluid delivered to the fluid line includes a gas bubble ([0090] the controller device 200 can output instructions to the user using the display 222 (e.g., refer to fig. 1). For example, in response to a detected ambient pressure drop the user may be provided with instructions to inspect the flexible tube 72 of the infusion set 70 to check if any bubbles are present).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to include the determination and control/indication steps taught by Estes with the microcontroller of Wyeth since both references deal with drug delivery systems and Wyeth already discloses a pressure sensor in communication with a controller, and based on the pressure measured in the fluid pathway downstream of the pump before fluidically connecting the dosing chamber with the fluid line (as taught by Wyeth above), a baseline pressure as taught by Estes since this would allow immediate monitoring of pressure changes over time and thus facilitate bubble sensing. One would have been motivated to make the modification because, as noted by Estes [0090], bubble formation may lead to unintentional delivery of additional medicine to user, so it would be beneficial to track possible bubble formation events. Since bubbles in fluid delivery to patients can be dangerous, it would be beneficial to have warning as early as possible if there were to be a bubble incident.
Regarding claim 12, Wyeth modified by Wyeth and Estes disclose the method of claim 11, as described above. Wyeth further discloses wherein the pump (416/406) includes a dosing chamber (mixing chamber 406, fig. 4K, [0111]), wherein the pump is configured to cyclically (i) pump the reservoir (water purifier 420, fig. 4C) with the dosing chamber (mixing container 406, fig. 4C) in fluid communication with the reservoir and not in fluid communication with the fluid line (see fig. 4C where arrows indicate flow path, [0116] controller 410 generates a command to flow purified water from the water purifier 420 to the mixing container 406) and (ii) fluidically connect the dosing chamber (406) with the fluid line (fill/drain line 450, fig. 4K), and wherein the fluid is delivered to the fluid line when the dosing chamber is fluidically connected with the fluid line ([0125] the contents of the mixing container 406 may be conveyed as illustrated in fig. 4K to the patient. Here the controller 410 has configured the fluid circuit with pump and valve network 416 to flow fluid to a patient 412).
Regarding claim 13, Wyeth modified by Wyeth and Estes disclose the method of claim 12, as described above, including further comprising: before fluidically connecting the dosing chamber with the fluid line (note that fig. 4A shows the system prior to pumping or the connection of dosing chamber 406 with fill/drain line 450 shown in fig. 4K):
measuring, with the pressure sensor (pressure sensor 414, fig. 4A, [0109]), the pressure in the fluid pathway downstream of the pump (pump and valve network 416 and mixing container 406, fig. 4A) ([0109] The controller applies control signals to a fluid conveyer and valve network 416 and a water purifier 420 and receives signals from distal and proximal pressure sensors 413 and 414, respectively, on a fill/drain line 450 which may be in accord with foregoing embodiments.).
Wyeth is silent to determining a baseline pressure and determining the presence of a gas bubble based on the measured pressure and baseline pressure.
Estes, in the art of an infusion pumps and methods, further teaches determining a baseline pressure (see 112b interpretation above) ([0082] the method 600 may include operation 610, in which a baseline ambient air pressure is established as the initial pressure measured by the pressure sensor 250), and wherein whether the fluid delivered to the fluid line includes a gas bubble based on the pressure measured in the fluid pathway downstream of the pump as the fluid is delivered to the fluid line and the baseline pressure ([0090] the controller device 200 can output instructions to the user using the display 222 (e.g., refer to fig. 1). For example, in response to a detected ambient pressure drop the user may be provided with instructions to inspect the flexible tube 72 of the infusion set 70 to check if any bubbles are present).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the device of claim 1 to have the microcontroller of claim 1 (see claim 1) to be further programmed and/or configured to determine, based on the pressure measured in the fluid pathway downstream of the pump (taught by Wyeth in claim 1) before fluidically connecting the dosing chamber with the fluid line, a baseline pressure as taught by Estes since this would allow immediate monitoring of pressure changes over time and thus facilitate bubble sensing. One would have been motivated to make the modification because bubbles in fluid delivery to patients can be dangerous, so it would be beneficial to have warning as early as possible if there were to be a bubble incident.
Regarding claim 14, Wyeth modified by Wyeth ([0550]) and Estes discloses the method of claim 11, as described above, including wherein determining whether the fluid delivered to the fluid line includes a gas bubble includes:
comparing the pressure measured in the fluid pathway downstream of the pump (Wyeth: 416/406, fig. 4K, [0110]; Estes: pump device 100, fig. 1, [0090]) as the fluid is delivered to the fluid line (Wyeth: fill/drain line 450, fig. 4K, [0109]; Estes: flexible tube 72, fig. 1, [0090]) to a threshold pressure (Estes: [0083] measured air pressure values can be compared to threshold limit values that have been programmed and stored in the controller device 200); and
in response to the pressure measured in the fluid pathway downstream of the pump as the fluid is delivered to the fluid line satisfying the threshold pressure, determining that the fluid delivered to the fluid line includes a gas bubble (Wyeth: [0090] controller device 200 can alert user that bubble is present if a significant pressure decrease is sensed).
Regarding claim 15, Wyeth modified by Wyeth ([0550]) and Estes discloses the method of claim 11, as described above, including wherein determining whether the fluid delivered to the fluid line includes a gas bubble includes:
determining, based on the pressure measured in the fluid pathway downstream (see Wyeth fig. 4K, note that the pressure sensor 414 is downstream of the pump and valve network 416) of the pump (Wyeth: 416/406, fig. 4K, [0110]; Estes: pump device 100, fig. 1, [0090]) as the fluid is delivered to the fluid line (Wyeth: fill/drain line 450, fig. 4K, [0109]; Estes: flexible tube 72, fig. 1, [0090]),
comparing the pressure (see 103 below for rate of change rationale) as the fluid is delivered to the fluid line to a threshold pressure (see 103 below for rate of change rationale) (Estes: [0083] measured air pressure values can be compared to threshold limit values that have been programmed and stored in the controller device 200); and
in response to the pressure (see 103 below for rate of change rationale) as the fluid is delivered to the fluid line satisfying the threshold pressure (see 103 below for rate of change rationale), determine that the fluid delivered to the fluid line includes a gas bubble (Wyeth: [0090] controller device 200 can alert user that bubble is present if a significant pressure decrease is sensed).
Wyeth, Wyeth [0550], and Estes are silent to determining a rate of change and using the rate of change of the pressure instead of the pressure.
Wyeth [0288] teaches using a rate of change of pressure in place of an absolute pressure ([0288] Note that instead of an absolute (gauge or absolute pressure in absolute terms) pressure, the controller 807 at S404A may respond to a predefined rate of change of pressure or a predefined total pressure change over a predefined interval of time.)
Thus, the device as further modified by Wyeth [0288] discloses determining, based on the pressure measured in the fluid pathway downstream (see Wyeth fig. 4K, note that the pressure sensor 414 is downstream of the pump and valve network 416) of the pump (Wyeth: 416/406, fig. 4K, [0110]; Estes: pump device 100, fig. 1, [0090]) as the fluid is delivered to the fluid line (Wyeth: fill/drain line 450, fig. 4K, [0109]; Estes: flexible tube 72, fig. 1, [0090]), a rate of change (Wyeth [0288]: rate of change of pressure may be used instead of pressure) associated with the pressure measured in the fluid pathway downstream of the pump as the fluid is delivered to the fluid line (Wyeth as shown in fig. 4K, see noted elements above).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to the microcontroller of Wyeth modified by Wyeth [0550] and Estes to use the rate of change of the pressure instead of the pressure itself, since Wyeth [0288] teaches that a controller may respond to a rate of change of pressure instead of a pressure. Thus, using the rate of change of pressure instead of the pressure itself would be a simple substitution of known alternatives in the art and produce predictable results. One would have been motivated to make the modification because monitoring the pressure related to time may provide a better indication of when sudden changes may occur that would be likely to impact the device.
Regarding claim 17, Wyeth modified by Wyeth ([0550]) and Estes discloses the method of claim 11, as described above, including wherein determining whether the fluid delivered to the fluid line includes a gas bubble includes:
comparing the pressure (see 103 rationale below variation) to a threshold pressure (see rationale for variation below) (Estes: [0083] measured air pressure values can be compared to threshold limit values that have been programmed and stored in the controller device 200); and
in response to the pressure (see 103 rationale below for variation) satisfying the threshold pressure (see 103 rationale below for variation), determining that the fluid delivered to the fluid line during the period of time includes a gas bubble (Wyeth: [0090] controller device 200 can alert user that bubble is present if a significant pressure decrease is sensed).
Wyeth, Wyeth [0550], and Estes are silent to determining a rate of change and using the rate of change of the pressure instead of the pressure.
Wyeth [0288] teaches using variation in the pressure over a period of time (a predefined total pressure change over a predefined interval of time, noted in [0288]) in place of an absolute pressure ([0288] Note that instead of an absolute (gauge or absolute pressure in absolute terms) pressure, the controller 807 at S404A may respond to a predefined rate of change of pressure or a predefined total pressure change over a predefined interval of time.)
Thus, the device as further modified by Wyeth [0288] discloses determining, based on the pressure measured in the fluid pathway downstream (see Wyeth fig. 4K, note that the pressure sensor 414 is downstream of the pump and valve network 416) of the pump (Wyeth: 416/406, fig. 4K, [0110]; Estes: pump device 100, fig. 1, [0090]) as the fluid is delivered to the fluid line (Wyeth: fill/drain line 450, fig. 4K, [0109]; Estes: flexible tube 72, fig. 1, [0090]), a variation in the pressure over a period of time (Wyeth [0288] a predefined total pressure change over a predefined interval of time).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to the microcontroller of Wyeth modified by Wyeth [0550] and Estes to use the variation in the pressure over a period of time instead of the pressure itself, since Wyeth [0288] teaches that a controller may respond to a rate of change of pressure instead of a pressure. Thus, using the variation in the pressure over a period of time instead of the pressure itself would be a simple substitution of known alternatives in the art and produce predictable results. One would have been motivated to make the modification because monitoring the pressure related to time may provide a better indication of when sudden changes may occur that would be likely to impact the device.
Regarding claim 20, Wyeth discloses a computer program product for pressure sensor based gas bubble detection for a drug delivery device (peritoneal dialysis fluid proportioner/cycler 400, fig. 4K, [0109]) comprising a controller (controller 410, fig. 4K, [0125]), a pressure sensor (pressure sensor 414, fig. 4K, [0109]), and a fluid pathway (see fig. 4K) including a reservoir (water purifier 420, fig. 4K, [0112] The water purifier 420 may be a purifier or any source of sterile and purified water including a pre-sterilized container of water or multiple containers.) configured to receive a fluid (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.; see fig. 4K which shows water linked to the water purifier, and see [0112]), a pump (416/406) downstream of the reservoir (see fig. 4K, note [0112] pump and valve network 416 has a purified water line 431 for receiving water), and a fluid line (line 450, fig. 4K) downstream of the pump (416/406) (see fig. 4K, note that fill/drain line 450 is nearest to patient/outlet),
the controller (controller 410) being used to ([0109] the controller applies control signals to a fluid conveyer and valve network 416 and a water purifier 420 and receives signals from distal and proximal pressure sensors 413 and 414, respectively, on a fill/drain line 450):
control the pump (416/406) to deliver the fluid from the reservoir (water purifier 420) to the fluid line (fill/drain line 450, fig. 4K, [0150]) ([0150] water may be pumped into the mixing container and then into the fill/drain line 450);
control the pressure sensor (pressure sensor 414) to measure a pressure in the fluid pathway downstream (see fig. 4K) of the pump (416/406) as the fluid is delivered to the fluid line (450) ([0109] the controller receives signals from distal and proximal pressure sensors 413 and 414 on a fill/drain line 450); and
receive, from the pressure sensor (pressure sensor 414), the pressure measured in the fluid pathway downstream of the pump as the fluid is delivered to the fluid line (fill/drain line 450) ([0109] the controller receives signals from distal and proximal pressure sensors 413 and 414 on a fill/drain line 450);
record, at the beginning of each delivery cycle (pressure sensor 414, fig. 4A, [0109]), while the dosing chamber (mixing container 406) is fluidically isolated from the fluid line (fill/drain line 450, fig. 4A) (note that fig. 4A and fig. 4B shows the system prior to pumping or the connection of dosing chamber 406 with fill/drain line 450 shown in fig. 4K), a downstream pressure from the pressure sensor ([0109] The controller applies control signals to a fluid conveyer and valve network 416 and a water purifier 420 and receives signals from distal and proximal pressure sensors 413 and 414, respectively, on a fill/drain line 450 which may be in accord with foregoing embodiments.).
Wyeth, as described in reference to figures 4A to 4L, is silent to the controller being a microcontroller and the computer program product comprising at least one non-transitory computer readable medium.
A second embodiment of Wyeth teaches a microcontroller and a computer program product including at least one non-transitory computer readable medium ([0550] notes that embodiments of the method and system may be implemented using, among other listed options, a programmed microcontroller or a computer program product (software program stored on a non-transitory computer readable medium).).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to use the computer program product and microcontroller taught by Wyeth [0550] in place of the controller of Wyeth to have the computer program product comprising at least one non-transitory computer-readable medium including program instructions that are executed by a microcontroller perform the steps disclosed by Wyeth since Wyeth [0550] teaches the computer program product and microcontroller being used to implement methods and systems, and Wyeth as described in reference to figures 4A-L represents one of those methods and systems. This would have been a simple substitution with components known in the art and would have produced predictable results.
Wyeth is silent to the microcontroller using the pressure to determine the presence of a gas bubble and providing an indication associated with the determination.
Estes, in the art of infusion pumps and methods, teaches
record, at the beginning of each delivery cycle (see delivery cycle/method 600 in fig. 12; [0082] In some implementations, the baseline ambient air pressure can be the initial air pressure measured by the pressure sensor 250 at the time that the medicine cartridge 120 is installed into the pump device 100, and the pump device 100 is coupled to the controller device 200), a baseline pressure from the pressure sensor (see step 610 in fig. 12, “Establish a baseline ambient pressure”);
determine, during the delivery cycle (see fig. 12, see box 620, “Detect an ambient pressure change event”), based on the pressure measured in the fluid pathway downstream of the pump (pump device 100, fig. 1, [0090]) as the fluid is delivered to the fluid line (flexible tube 72, fig. 1, [0090]) and relative to the baseline (see 112b interpretation above), whether the fluid delivered to the fluid line includes a gas bubble ([0083] pressure sensor 250 measures ambient air pressure, thus pressure measured in the fluid pathway downstream of the pump device 100 of the infusion pump system 10, and compares the measured value to stored threshold limit values; see fig. 1; [0090] a detected ambient pressure drop may indicate the presence of a gas bubble); and
control an output device (display 222, fig. 1, [0090]) to provide an indication associated with the determination of whether the fluid delivered to the fluid line includes a gas bubble ([0090] the controller device 200 can output instructions to the user using the display 222 (e.g., refer to fig. 1). For example, in response to a detected ambient pressure drop the user may be provided with instructions to inspect the flexible tube 72 of the infusion set 70 to check if any bubbles are present).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to include the determination and control/indication steps taught by Estes with the microcontroller of Wyeth since both references deal with drug delivery systems and Wyeth already discloses a pressure sensor in communication with a controller, and based on the pressure measured in the fluid pathway downstream of the pump before fluidically connecting the dosing chamber with the fluid line (as taught by Wyeth above), a baseline pressure as taught by Estes since this would allow immediate monitoring of pressure changes over time and thus facilitate bubble sensing. One would have been motivated to make the modification because, as noted by Estes [0090], bubble formation may lead to unintentional delivery of additional medicine to user, so it would be beneficial to track possible bubble formation events. Since bubbles in fluid delivery to patients can be dangerous, it would be beneficial to have warning as early as possible if there were to be a bubble incident.
Claim(s) 6, 8, 16, and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wyeth modified by Wyeth and Estes as applied to claim 1, 7, 11, or 17 above, and further in view of Clark et al (WO 2005119181 A1; hereafter Clark).
Regarding claim 6, Wyeth modified by Wyeth and Estes disclose drug delivery device of claim 1, including the microcontroller (see rejection of claim 1).
Wyeth as described in relation to figures 4A-4L and Estes are silent to a pressure associated with the fluid pathway upstream of the pump.
Wyeth [0238] teaches receive a pressure associated with the fluid pathway upstream of the pump (see fig. 17A, and [0191], note that one of pressure sensors 769 is upstream of pump 762), and determine a pressure associated with the fluid pathway upstream of the pump and a pressure associated with the fluid pathway downstream of the pump ([0191] pressure sensors 769 are positioned on either side of the pump 762 to detect pump inlet and outlet pressures in pump tube 763; see fig. 17A).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to include pressure sensors on either side of the pump as taught by Wyeth [0238] with the device of Wyeth modified by Wyeth and Estes because Wyeth and Estes both deal with pressure monitoring in fluid delivery systems. One would have been motivated to make the modification because the close monitoring of the pump inlet and outlet would help ensure that the pump is functioning correctly and should be consistent over time.
Wyeth and Estes are silent to determining a volume of a gas bubble or a volume of fluid delivered to a fluid line.
Clark, in the art of flow rate measurements, teaches determine, based on the pressure associated with the fluid pathway upstream (pg. 30 ln. 13-27, pressure is taken at an upstream location), the pressure measured in the fluid pathway downstream as the fluid is delivered to the fluid line (pg. 30 ln. 13-27, pressure is taken at a downstream location), and dimensions of the fluid pathway (cross sectional area of the flow path is noted in pg. 34 ln. 21-22), at least one of a volume of the gas bubble included in the fluid delivered to the fluid line (pg. 34 ln. 10-22, presence of a gas bubble is indicated by a pressure differential of zero, and the volume of the bubble can be calculated using the time which it takes for the pressures to be restored and the cross-sectional area of the flow path), a volume of the fluid delivered to the fluid line (pg. 30 ln. 13-27, the difference in two pressure readings taken at an upstream location 54 and a downstream location 58 with capacitive pressure sensors can be used to calculate a volume flow rate), or any combination thereof.
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to use the pressure sensors on either side of the pump, as taught by Wyeth, to determine an upstream pressure, and to use the known pressures and cross section as taught by Clark, with the device of Wyeth modified by Wyeth and Estes because Clark also deals with a fluid delivery system. One would have been motivated to make the modification because the system of Clark allows a user to more closely monitor bubble volume which would help a user avoid accidental infusion of additional fluid or accidental bubble infusion, either of which could be detrimental to a patient.
Regarding claim 8, Wyeth modified by Wyeth and Estes discloses the drug delivery device of claim 7, as described above, including the microcontroller (Wyeth [0550] microcontroller may be used) and the variation in the pressure over the period of time (Wyeth [0288] a predefined total pressure change over a predefined interval of time).
Wyeth as described in relation to figures 4A-4L and Estes are silent to a pressure associated with the fluid pathway upstream of the pump.
Wyeth [0238] teaches receive a pressure associated with the fluid pathway upstream of the pump (see fig. 17A, and [0191], note that one of pressure sensors 769 is upstream of pump 762), and determine a pressure associated with the fluid pathway upstream of the pump and a pressure associated with the fluid pathway downstream of the pump ([0191] pressure sensors 769 are positioned on either side of the pump 762 to detect pump inlet and outlet pressures in pump tube 763; see fig. 17A).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to include pressure sensors on either side of the pump as taught by Wyeth [0238] with the device of Wyeth modified by Wyeth and Estes because Wyeth and Estes both deal with pressure monitoring in fluid delivery systems. One would have been motivated to make the modification because the close monitoring of the pump inlet and outlet would help ensure that the pump is functioning correctly and should be consistent over time.
Wyeth and Estes are silent to the microcontroller being further configured to determine, based on the pressure variation over the period of time, the volume of a gas bubble or volume of fluid delivered to the fluid line.
Clark teaches determine, based on the variation in the pressure (pg. 34 ln. 10-22, presence of a gas bubble is indicated by a pressure differential of zero, and the volume of the bubble can be calculated using the time which it takes for the pressures to be restored and the cross sectional area of the flow path) over the period of time (pg. 34 ln. 10-22 time the bubble traverse the device is measured as seen in fig. 21), at least one of a volume of the gas bubble included in the fluid delivered to the fluid line (pg. 34 ln. 10-22, volume of the bubble can be calculated using the time which it takes for the pressures to be restored and the cross-sectional area of the flow path), a volume of the fluid delivered to the fluid line, or any combination thereof.
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the device of Wyeth modified by Wyeth and Estes to include the bubble volume calculation capability taught by Clark since both Clark and Wyeth deal with fluid delivery and pressure sensors. One would have been motivated to make the modification because the system of Clark allows a user to more closely monitor bubble volume which would help a user avoid accidental infusion of additional fluid or accidental bubble infusion, either of which could be detrimental to a patient.
Regarding claim 16, Wyeth modified by Wyeth and Estes disclose the method of claim 11, as described above, including the microcontroller (see rejection of claim 11).
Wyeth as described in relation to figures 4A-4L and Estes are silent to a pressure associated with the fluid pathway upstream of the pump.
Wyeth [0238] teaches receiving a pressure associated with the fluid pathway upstream of the pump (see fig. 17A, and [0191], note that one of pressure sensors 769 is upstream of pump 762), and determining a pressure associated with the fluid pathway upstream of the pump and a pressure associated with the fluid pathway downstream of the pump ([0191] pressure sensors 769 are positioned on either side of the pump 762 to detect pump inlet and outlet pressures in pump tube 763; see fig. 17A).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to include pressure sensors on either side of the pump as taught by Wyeth [0238] with the device of Wyeth modified by Wyeth and Estes because Wyeth and Estes both deal with pressure monitoring in fluid delivery systems. One would have been motivated to make the modification because the close monitoring of the pump inlet and outlet would help ensure that the pump is functioning correctly and should be consistent over time.
Wyeth and Estes are silent to determining a volume of a gas bubble or a volume of fluid delivered to a fluid line.
Clark, in the art of flow rate measurements, teaches determine, based on the pressure associated with the fluid pathway upstream (pg. 30 ln. 13-27, pressure is taken at an upstream location), the pressure measured in the fluid pathway downstream as the fluid is delivered to the fluid line (pg. 30 ln. 13-27, pressure is taken at a downstream location), and dimensions of the fluid pathway (cross sectional area of the flow path is noted in pg. 34 ln. 21-22), at least one of a volume of the gas bubble included in the fluid delivered to the fluid line (pg. 34 ln. 10-22, presence of a gas bubble is indicated by a pressure differential of zero, and the volume of the bubble can be calculated using the time which it takes for the pressures to be restored and the cross-sectional area of the flow path), a volume of the fluid delivered to the fluid line (pg. 30 ln. 13-27, the difference in two pressure readings taken at an upstream location 54 and a downstream location 58 with capacitive pressure sensors can be used to calculate a volume flow rate), or any combination thereof.
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to use the microcontroller of Wyeth modified by Wyeth and Estes with the pressure sensors on either side of the pump, as taught by Wyeth [0238], to determine an upstream pressure, and to use the known pressures and cross section as taught by Clark, with the device of Wyeth modified by Wyeth and Estes because Clark also deals with a fluid delivery system. One would have been motivated to make the modification because the system of Clark allows a user to more closely monitor bubble volume which would help a user avoid accidental infusion of additional fluid or accidental bubble infusion, either of which could be detrimental to a patient.
Regarding claim 18, Wyeth modified by Wyeth and Estes discloses the method of claim 17, as described above, including the microcontroller (Wyeth [0550] microcontroller may be used) and the variation in the pressure over the period of time (Wyeth [0288] a predefined total pressure change over a predefined interval of time).
Wyeth as described in relation to figures 4A-4L and Estes are silent to a pressure associated with the fluid pathway upstream of the pump.
Wyeth [0238] teaches receiving a pressure associated with the fluid pathway upstream of the pump (see fig. 17A, and [0191], note that one of pressure sensors 769 is upstream of pump 762), and determining a pressure associated with the fluid pathway upstream of the pump and a pressure associated with the fluid pathway downstream of the pump ([0191] pressure sensors 769 are positioned on either side of the pump 762 to detect pump inlet and outlet pressures in pump tube 763; see fig. 17A).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to include pressure sensors on either side of the pump as taught by Wyeth [0238] with the device of Wyeth modified by Wyeth and Estes because Wyeth and Estes both deal with pressure monitoring in fluid delivery systems. One would have been motivated to make the modification because the close monitoring of the pump inlet and outlet would help ensure that the pump is functioning correctly and should be consistent over time.
Wyeth and Estes are silent to determining, with the microcontroller, based on the pressure variation over the period of time, the volume of a gas bubble or volume of fluid delivered to the fluid line.
Clark teaches determining, based on the variation in the pressure (pg. 34 ln. 10-22, presence of a gas bubble is indicated by a pressure differential of zero, and the volume of the bubble can be calculated using the time which it takes for the pressures to be restored and the cross-sectional area of the flow path) over the period of time (pg. 34 ln. 10-22 time the bubble traverse the device is measured as seen in fig. 21), at least one of a volume of the gas bubble included in the fluid delivered to the fluid line (pg. 34 ln. 10-22, volume of the bubble can be calculated using the time which it takes for the pressures to be restored and the cross-sectional area of the flow path), a volume of the fluid delivered to the fluid line, or any combination thereof.
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the device of Wyeth modified by Wyeth and Estes to include the bubble volume calculation capability taught by Clark since both Clark and Wyeth deal with fluid delivery and pressure sensors. One would have been motivated to make the modification because the system of Clark allows a user to more closely monitor bubble volume which would help a user avoid accidental infusion of additional fluid or accidental bubble infusion, either of which could be detrimental to a patient.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wyeth modified by Wyeth and Estes as applied to claim 1 above, and further in view of Peatfield et al (US 20110043357 A1; hereafter Peatfield).
Regarding claim 9, Wyeth modified by Wyeth and Estes discloses the drug delivery device of claim 1, as described above, including a pressure sensor.
Wyeth and Estes are silent to the pressure sensor being an absolute pressure sensor or a differential pressure sensor.
Peatfield, in the field of medicine delivery devices, teaches wherein the pressure sensor (pressure sensors 266A and 266B, fig. 3, [0047]) includes at least one of the following: an absolute pressure sensor ([0047] The pressure sensors 266A, 266B are absolute pressure sensors), a differential pressure sensor ([0040] A relative pressure sensor, e.g., a gauge MEMS sensor, may be used to replace both absolute pressure sensors.), or any combination thereof.
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to use the absolute pressure sensor or a differential pressure as taught by Peatfield as the pressure sensor of Wyeth modified by Wyeth and Estes, since all references deal with medical fluid delivery devices and employ pressure sensors. One would have been motivated to make the modification because the absolute pressure sensors allow the system to monitor not only the ambient pressure but also the pressure directly in the line, thus keeping track of the internal environment as well as the environmental pressure in such a way that the difference can be compared and tracked.
Claim(s) 10 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wyeth modified by Wyeth and Estes as applied to claim 1 or 11 above, and further in view of Parker (US 20210170102 A1; hereafter Parker).
Regarding claim 10, Wyeth modified by Wyeth and Estes disclose drug delivery device of claim 1, as described above, including wherein the microcontroller is further programmed and/or configured to: receive, from the pressure sensor (Wyeth: pressure sensor 414), the pressure measured in the fluid pathway (fig. 4K) downstream of the pump (pump and valve network 416 and mixing container 406, fig. 4A).
Wyeth and Estes are silent to monitoring pressure during the priming of the pump.
Parker, in the art of fluid injector systems, teaches monitoring pressure during a priming of the pump ([0111] pressure is monitored during the priming operation as fluid flows; [0084] device includes a pump 132); and
determine, based on the pressure measured in the fluid pathway downstream of the pump during the priming of the pump, whether the pump is fully primed ([0134] control unit 900 may determine whether the device has been fully primed based on the distinct pressure profile 730).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to monitor pressure during the priming of the pump to determine whether or not the pump is fully primed, as taught by Parker, as part of the operations of Wyeth modified by Estes because Wyeth also deals with priming a fluid delivery device. One would have been motivated to make the modification because this modification would allow a user to ensure that the device is fully primed prior to use, thus helping to ensure patient safety and treatment effectiveness.
Regarding claim 19, Wyeth modified by Wyeth and Estes disclose method of claim 11, including measuring, with the pressure sensor (Wyeth: pressure sensor 414), a pressure measured in the fluid pathway (fig. 4K) downstream of the pump (pump and valve network 416 and mixing container 406, fig. 4A), and
receiving, with the microcontroller (see claim 11 rejection), from the pressure sensor (414), the pressure measured in the fluid pathway downstream of the pump ([0109] controller receives signals from distal and proximal pressure sensors 413 and 414).
Wyeth and Estes are silent to monitoring pressure during the priming of the pump.
Parker, in the art of fluid injector systems, teaches measuring pressure during a priming of the pump ([0111] pressure is monitored during the priming operation as fluid flows; [0084] device includes a pump 132); and
determining, based on the pressure measured in the fluid pathway downstream of the pump during the priming of the pump, whether the pump is fully primed ([0134] control unit 900 may determine whether the device has been fully primed based on the distinct pressure profile 730).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to monitor another pressure during the priming of the pump to determine whether or not the pump is fully primed, as taught by Parker, as part of the operations of Wyeth modified by Estes because Wyeth also deals with priming a fluid delivery device. One would have been motivated to make the modification because this modification would allow a user to ensure that the device is fully primed prior to use, thus helping to ensure patient safety and treatment effectiveness.
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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/I.S.N./Examiner, Art Unit 3783
/JASON E FLICK/ Primary Examiner, Art Unit 3783 12/23/2025