DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The Amendments filed 10/29/2025 have been entered.
Claims 1, 4, 5, 7, 9, 12, 13, 15 and 17 have thereby been amended.
Claims 6, 14 and 19 have been cancelled.
Claims 1-5, 7-13, 15-18 and 20 are being examined in this office action.
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 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Gravesen (US 20110046558) in view of Carter (US 20100286602).
Regarding claim 1, Gravesen discloses a drug delivery device (100), comprising: a fluid pathway including a reservoir (252), a pump (the elastomer which surrounds the 252 vessel and contracts to force/pump the fluid out; page 3, para. [0032], sentence 1) and a fluid line downstream of the pump (Fig. 3: fluid line 262), wherein the reservoir is configured to receive a fluid (page 9, para. [0063], sentences 3-4; an injection pen 254a fills the reservoir 252 via fill port 254), wherein the pump is configured to deliver the fluid from the reservoir to the fluid line (page 3, para. [0032], sentence 1), a pressure sensor configured to measure a pressure in the fluid pathway (Fig. 3: pressure sensor 266A measures at fluid pathway 262; page 7, para. [0056], sentence 1); and a microcontroller (the processors of the printed circuit boards of the sensing unit 120; Fig. 6: page 4, para. [0039], sentences 6-7) programmed and/or configured to: receive, from the pressure sensor, the pressure measured in the fluid pathway (page 6, para. [0053], sentence 1; Fig. 6: page 4, para. [0039], sentences 6-7); determine, based on the pressure measured in the fluid pathway, whether the reservoir is empty of the fluid (page 1, para. [0011], sentences 3-4); and control an output device to provide an indication associated with the determination of whether the reservoir is empty of the fluid (page 1, para. [0011], sentences 3-4; page 6, para. [0054], last sentence). However, Gravesen discloses the pump and reservoir, as described above, as a single unit, and fails to disclose the pump being downstream of the reservoir. Gravesen also fails to disclose a dosing chamber in association with the reservoir and pump.
Carter teaches an analogous drug delivery device configured to determine when the reservoir is empty, with a pump (Fig. 7: pump 172+210) downstream of the reservoir (Fig. 7: pump 172+210 is downstream of reservoir 180). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Gravesen drug delivery device by replacing the Gravesen pump/reservoir (252) with the reservoir and downstream pump with the integrated valve mechanisms taught by Carter (as depicted in the annotated figure below), in order to incorporate the precise and consistent dosing mechanism created by the pump/valve mechanism of Carter (Figs. 7 and 8: page 4, para. [0054], sentences 3-6; page 4, para. [0055], sentence 3).
The analogous drug delivery device of Carter further teaches that wherein the pump includes a dosing chamber (170) and wherein the pump is configured to cyclically (i) pump the reservoir with the dosing chamber in fluid communication with the reservoir and the dosing chamber not in fluid communication with the fluid line (Fig. 7: the positioning of shuttle valve 210 seals off the fluid line at 125/130, creating fluid communication between 180 and 172 depicted by the arrows, and no fluid communication between 172 and 125/130) and (ii) fluidically connect, with the dosing chamber not in fluid communication with the reservoir, the dosing chamber with the fluid line (Fig. 8: the positioning of shuttle valve 210 seals off the reservoir 180, creating fluid communication between 172 and 125/130 depicted by the arrows, and no fluid communication between 172 and 180). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have also incorporated the dosing chamber of the Carter pump into the Gravesen drug delivery device upon the combination described above, in order to ensure that precise amounts of the fluid are being administered with each cycle of the pump (Carter: para. [0054], second-to-last sentence). Upon this combination, described above and depicted in the annotated figure below, it would directly follow that the measuring of the pressure by the pressure sensor in the fluid pathway (and subsequent receiving and determining based on this measuring), taught by Gravesen, would occur with the dosing chamber not in fluid communication with the reservoir and the dosing chamber fluidically connected with the fluid line (Carter: Fig. 8: the positioning of shuttle valve 210 seals off the reservoir 180, creating fluid communication between 172 and 125/130 depicted by the arrows, and no fluid communication between 172 and 180; page 5, para. [0063], sentences 6-8), since the fluid is pumped through and flows through the fluid line when the dosing chamber is fluidically connected with the fluid line, at which point the sensor measures the pressure of that fluid moving through the fluid line.
PNG
media_image1.png
359
663
media_image1.png
Greyscale
Regarding claim 2, Gravesen in view of Carter teaches the drug delivery device of claim 1, as described above, wherein the pressure sensor is in the fluid pathway downstream of the pump (Gravesen: sensor 266A downstream of pump at 252).
Regarding claim 3, Gravesen in view of Carter teaches the drug delivery device of claim 1, as described above, wherein the pressure sensor is in the fluid pathway upstream of the pump (Carter: pressure sensor upstream of pump 172; page 2, para. [0013], last sentence). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Gravesen-Carter device to move the pressure sensor upstream of the pump, as taught by Carter, in order to measure the pressure in fluid pathway at 182 of Carter to directly measure the pressure, and therefore remaining volume, in the reservoir directly rather than in the fluid lines in the device downstream.
Regarding claim 4, Gravesen in view of Carter teaches the drug delivery device of claim 1, as described above, wherein the microcontroller is programmed and/or configured to determine whether the reservoir is empty of the fluid by: comparing the pressure measured in the fluid pathway with the dosing chamber not in fluid communication with the reservoir and the dosing chamber fluidically connected with the fluid line (Carter: Fig. 8: the positioning of shuttle valve 210 seals off the reservoir 180, creating fluid communication between 172 and 125/130 depicted by the arrows, and no fluid communication between 172 and 180; page 5, para. [0063], sentences 6-8) to a threshold pressure and in response to the pressure measured in the fluid pathway (Gravesen: page 1, para. [0011], sentences 2-4; pressure thresholds of minimum and maximum pressures of range) with the dosing chamber not in fluid communication with the reservoir and the dosing chamber fluidically connected with the fluid line (Carter: Fig. 8: the positioning of shuttle valve 210 seals off the reservoir 180, creating fluid communication between 172 and 125/130 depicted by the arrows, and no fluid communication between 172 and 180; page 5, para. [0063], sentences 6-8) satisfying the threshold pressure, determining that the reservoir is empty of the fluid (Gravesen: page 1, para. [0011], sentences 2-4; pressure thresholds of minimum and maximum pressures of range).
Regarding claim 5, Gravesen in view of Carter teaches the drug delivery device of claim 1, as described above, wherein the microcontroller is programmed and/or configured to determine whether the reservoir is empty of the fluid by: determining, based on the pressure measured in the fluid pathway with the dosing chamber not in fluid communication with the reservoir and the dosing chamber fluidically connected with the fluid line (Carter: Fig. 8: the positioning of shuttle valve 210 seals off the reservoir 180, creating fluid communication between 172 and 125/130 depicted by the arrows, and no fluid communication between 172 and 180; page 5, para. [0063], sentences 6-8), a rate of change associated with the pressure measured in the fluid pathway (Gravesen: page 3, para. [0032], sentence 13: sensor 266A senses pressure changes in fluid pathway 262); comparing the rate of change associated with the pressure measured in the fluid pathway with the dosing chamber not in fluid communication with the reservoir and the dosing chamber fluidically connected with the fluid line (Carter: Fig. 8: the positioning of shuttle valve 210 seals off the reservoir 180, creating fluid communication between 172 and 125/130 depicted by the arrows, and no fluid communication between 172 and 180; page 5, para. [0063], sentences 6-8) to a threshold rate of change (Gravesen: pressure changes in ambient air is the threshold rate of change; page 3, para. [0032], sentence 14; page 6, para. [0054], sentence 2, due to ambient pressure being baseline for comparison); and in response to the rate of change associated with the pressure measured in the fluid pathway with the dosing chamber not in fluid communication with the reservoir and the dosing chamber fluidically connected with the fluid line (Carter: Fig. 8: the positioning of shuttle valve 210 seals off the reservoir 180, creating fluid communication between 172 and 125/130 depicted by the arrows, and no fluid communication between 172 and 180; page 5, para. [0063], sentences 6-8) satisfying the threshold rate of change, determine that the reservoir is empty of the fluid (Gravesen: page 6, para. [0053]).
Regarding claim 7, Gravesen in view of Carter teaches the drug delivery device of claim 1, as described above, but fails to explicitly disclose that the pressure sensor measures the pressure in the fluid path when the dosing chamber is in fluid communication with the reservoir and not in fluid communication with the fluid line. However, since Carter teaches that the dosing chamber and therefore the actuator button (116) of the shuttle valve cyclically pumps/operates quickly (Carter: para. [0054], last sentence), it directly follows that the pressure sensor of Gravesen would also, at times, measure the pressure in the fluid pathway (Gravesen: Fig. 3: pressure sensor 266A measures at fluid pathway 262; page 7, para. [0056], sentence 1) with the dosing chamber in fluid communication with the reservoir and the dosing chamber not in fluid communication with the fluid line (Carter: Fig. 7: the positioning of shuttle valve 210 seals off the fluid line at 125/130, creating fluid communication between 180 and 172 depicted by the arrows, and no fluid communication between 172 and 125/130), and wherein the microcontroller is further programmed and/or configured to: receive, from the pressure sensor, the pressure measured in the fluid pathway (Gravesen: page 6, para. [0053], sentence 1; Fig. 6: page 4, para. [0039], sentences 6-7) with the dosing chamber in fluid communication with the reservoir and the dosing chamber not in fluid communication with the fluid line (Carter: Fig. 7: the positioning of shuttle valve 210 seals off the fluid line at 125/130, creating fluid communication between 180 and 172 depicted by the arrows, and no fluid communication between 172 and 125/130); and before fluidically connecting the dosing chamber with the fluid line, determine, based on the pressure measured in the fluid pathway with the dosing chamber not in fluid communication with the reservoir and the dosing chamber fluidically connected with the fluid line (Carter: Fig. 8: the positioning of shuttle valve 210 seals off the reservoir 180, creating fluid communication between 172 and 125/130depicted by the arrows, and no fluid communication between 172 and 180; page 5, para. [0063], sentences 6-8), a baseline pressure, wherein the microcontroller is programmed and/or configured to determine whether the reservoir is empty based on the pressure measured in the fluid pathway with the dosing chamber not in fluid communication with the reservoir and the dosing chamber fluidically connected with the fluid line (Carter: Fig. 8: the positioning of shuttle valve 210 seals off the reservoir 180, creating fluid communication between 172 and 125/130depicted by the arrows, and no fluid communication between 172 and 180; page 5, para. [0063], sentences 6-8) and the baseline pressure (Carter: page 2, para. [0014]; the fluid connection to the outlet will not be actuated if the pressure sensors and corresponding processors determine the reservoir is empty).
Regarding claim 8, Gravesen in view of Carter teaches the drug delivery device of claim 1, as described above, wherein the pressure sensor includes at least one of the following: an absolute pressure sensor (Gravesen: page 3, para. [0032], second-to-last sentence), a differential pressure sensor, or any combination thereof.
Regarding claim 9, Gravesen discloses a method for pressure sensor based empty reservoir detection for a drug delivery device (100) comprising a fluid pathway including a reservoir (252) configured to receive a fluid (page 9, para. [0063], sentences 3-4; an injection pen 254a fills the reservoir 252 via fill port 254), a pump (the elastomer which surrounds the 252 vessel and contracts to force/pump the fluid out; page 3, para. [0032], sentence 1), and a fluid line downstream of the pump (Fig. 3: fluid line 262), the method comprising: measuring, with a pressure sensor, a pressure in the fluid pathway (Fig. 3: pressure sensor 266A measures at fluid pathway 262; page 7, para. [0056], sentence 1); receiving, with a microcontroller, the pressure measured in the fluid pathway (the processors of the printed circuit boards of the sensing unit 120; Fig. 6: page 4, para. [0039], sentences 6-7); determining, with the microcontroller, based on the pressure measured in the fluid pathway, whether the reservoir is empty of the fluid (page 1, para. [0011], sentences 3-4); and controlling, with the microcontroller, an output device to provide an indication associated with the determination of whether the reservoir is empty of the fluid (page 1, para. [0011], sentences 3-4; page 6, para. [0054], last sentence). However, Gravesen discloses the pump and reservoir, as described above, as a single unit, and fails to disclose the pump being downstream of the reservoir. Gravesen also fails to disclose a dosing chamber in association with the reservoir and pump.
Carter teaches an analogous drug delivery device configured to determine when the reservoir is empty, with a pump (Fig. 7: pump 172) downstream of the reservoir (Fig. 7: pump 172 is downstream of reservoir 180). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Gravesen drug delivery device by replacing the Gravesen pump/reservoir (252) with the reservoir and downstream pump with the integrated valve mechanisms taught by Carter (as depicted in the annotated figure below), in order to incorporate the precise and consistent dosing mechanism created by the pump/valve mechanism of Carter (Figs. 7 and 8: page 4, para. [0054], sentences 3-6; page 4, para. [0055], sentence 3).
The analogous drug delivery device of Carter further teaches that wherein the pump includes a dosing chamber (170) and the method comprises cyclically (i) pumping the reservoir with the dosing chamber in fluid communication with the reservoir and not in fluid communication with the fluid line (Fig. 7: the positioning of shuttle valve 210 seals off the fluid line at 125/130, creating fluid communication between 180 and 172 depicted by the arrows, and no fluid communication between 172 and 125/130) and (ii) fluidically connecting with the dosing chamber not in fluid communication with the reservoir, the dosing chamber with the fluid line (Fig. 8: the positioning of shuttle valve 210 seals off the reservoir 180, creating fluid communication between 172 and 125/130 depicted by the arrows, and no fluid communication between 172 and 180). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have also incorporated the dosing chamber of the Carter pump into the Gravesen drug delivery device method upon the combination described above, in order to ensure that precise amounts of the fluid are being administered with each cycle of the pump (Carter: para. [0054], second-to-last sentence). Upon this combination, described above and depicted in the annotated figure below, it would directly follow that the measuring of the pressure by the pressure sensor in the fluid pathway (and subsequent receiving and determining based on this measuring), taught by Gravesen, would occur with the dosing chamber not in fluid communication with the reservoir and the dosing chamber fluidically connected with the fluid line (Carter: Fig. 8: the positioning of shuttle valve 210 seals off the reservoir 180, creating fluid communication between 172 and 125/130 depicted by the arrows, and no fluid communication between 172 and 180; page 5, para. [0063], sentences 6-8), since the fluid is pumped through and flows through the fluid line when the dosing chamber is fluidically connected with the fluid line, at which point the sensor measures the pressure of that fluid moving through the fluid line.
Regarding claim 10, Gravesen in view of Carter teaches the method of claim 9, as described above, wherein the pressure sensor measures the pressure in the fluid pathway downstream of the pump (Gravesen: sensor 266A downstream of pump at 252).
Regarding claim 11, Gravesen in view of Carter teaches the method of claim 9, as described above, wherein the pressure sensor measures the fluid in the fluid pathway upstream of the pump (Carter: pressure sensor upstream of pump 172; page 2, para. [0013], last sentence).
Regarding claim 12, Gravesen in view of Carter teaches the method of claim 9, as described above, wherein determining whether the reservoir is empty of fluid includes: comparing the pressure measured in the fluid pathway with the dosing chamber not in fluid communication with the reservoir and the dosing chamber fluidically connected with the fluid line (Carter: Fig. 8: the positioning of shuttle valve 210 seals off the reservoir 180, creating fluid communication between 172 and 125/130 depicted by the arrows, and no fluid communication between 172 and 180; page 5, para. [0063], sentences 6-8) to a threshold pressure and in response to the pressure measured in the fluid pathway with the dosing chamber not in fluid communication with the reservoir and the dosing chamber fluidically connected with the fluid line (Carter: Fig. 8: the positioning of shuttle valve 210 seals off the reservoir 180, creating fluid communication between 172 and 125/130 depicted by the arrows, and no fluid communication between 172 and 180; page 5, para. [0063], sentences 6-8) satisfying the threshold pressure, determining that the reservoir is empty of the fluid (Gravesen: page 1, para. [0011], sentences 2-4; pressure thresholds of minimum and maximum pressures of range).
Regarding claim 13, Gravesen in view of Carter teaches the method of claim 9, as described above, wherein determining whether the reservoir is empty of fluid includes: determining, based on the pressure measured in the fluid pathway with the dosing chamber not in fluid communication with the reservoir and the dosing chamber fluidically connected with the fluid line (Carter: Fig. 8: the positioning of shuttle valve 210 seals off the reservoir 180, creating fluid communication between 172 and 125/130 depicted by the arrows, and no fluid communication between 172 and 180; page 5, para. [0063], sentences 6-8), a rate of change associated with the pressure measured in the fluid pathway (Gravesen: page 3, para. [0032], sentence 13: sensor 266A senses pressure changes in fluid pathway 262); comparing the rate of change associated with the pressure measured in the fluid pathway with the dosing chamber not in fluid communication with the reservoir and the dosing chamber fluidically connected with the fluid line (Carter: Fig. 8: the positioning of shuttle valve 210 seals off the reservoir 180, creating fluid communication between 172 and 125/130 depicted by the arrows, and no fluid communication between 172 and 180; page 5, para. [0063], sentences 6-8) to a threshold rate of change (Gravesen: pressure changes in ambient air is the threshold rate of change; page 3, para. [0032], sentence 14; page 6, para. [0054], sentence 2, due to ambient pressure being baseline for comparison); and in response to the rate of change associated with the pressure measured in the fluid pathway with the dosing chamber not in fluid communication with the reservoir and the dosing chamber fluidically connected with the fluid line (Carter: Fig. 8: the positioning of shuttle valve 210 seals off the reservoir 180, creating fluid communication between 172 and 125/130 depicted by the arrows, and no fluid communication between 172 and 180; page 5, para. [0063], sentences 6-8) satisfying the threshold rate of change, determining that the reservoir is empty of the fluid (Gravesen: page 6, para. [0053]).
Regarding claim 15, Gravesen in view of Carter teaches the method of claim 9, as described above, but fails to explicitly disclose that the pressure sensor measures the pressure in the fluid path when the dosing chamber is in fluid communication with the reservoir and not in fluid communication with the fluid line. However, since Carter teaches that the dosing chamber and therefore the actuator button (116) of the shuttle valve cyclically pumps/operates quickly (Carter: para. [0054], last sentence), it directly follows that the pressure sensor of Gravesen would also, at times, comprise measuring, with the pressure sensor, the pressure in the fluid pathway (Gravesen: Fig. 3: pressure sensor 266A measures at fluid pathway 262; page 7, para. [0056], sentence 1) with the dosing chamber in fluid communication with the reservoir and the dosing chamber not in fluid communication with the fluid line (Carter: Fig. 7: the positioning of shuttle valve 210 seals off the fluid line at 125/130, creating fluid communication between 180 and 172 depicted by the arrows, and no fluid communication between 172 and 125/130); receiving, with the microcontroller, from the pressure sensor, the pressure measured in the fluid pathway (Gravesen: page 6, para. [0053], sentence 1; Fig. 6: page 4, para. [0039], sentences 6-7) with the dosing chamber in fluid communication with the reservoir and the dosing chamber not in fluid communication with the fluid line (Carter: Fig. 7: the positioning of shuttle valve 210 seals off the fluid line at 125/130, creating fluid communication between 180 and 172 depicted by the arrows, and no fluid communication between 172 and 125/130); and before fluidically connecting the dosing chamber with the fluid line, determining, with the microcontroller, based on the pressure measured in the fluid pathway with the dosing chamber not in fluid communication with the reservoir and the dosing chamber fluidically connected with the fluid line (Carter: Fig. 8: the positioning of shuttle valve 210 seals off the reservoir 180, creating fluid communication between 172 and 125/130depicted by the arrows, and no fluid communication between 172 and 180; page 5, para. [0063], sentences 6-8), a baseline pressure, wherein whether the reservoir is empty is determined based on the pressure measured in the fluid pathway with the dosing chamber not in fluid communication with the reservoir and the dosing chamber fluidically connected with the fluid line (Carter: Fig. 8: the positioning of shuttle valve 210 seals off the reservoir 180, creating fluid communication between 172 and 125/130depicted by the arrows, and no fluid communication between 172 and 180; page 5, para. [0063], sentences 6-8) and the baseline pressure (Carter: page 2, para. [0014]; the fluid connection to the outlet will not be actuated if the pressure sensors and corresponding processors determine the reservoir is empty).
Regarding claim 16, Gravesen in view of Carter teaches the method of claim 9, as described above, wherein the pressure sensor includes at least one of the following: an absolute pressure sensor (Gravesen: page 3, para. [0032], second-to-last sentence), a differential pressure sensor, or any combination thereof.
Regarding claim 17, Gravesen discloses a computer program product for pressure sensor based empty reservoir detection for a drug delivery device comprising a microcontroller (the processors of the printed circuit boards of the sensing unit 120; Fig. 6: page 4, para. [0039], sentences 6-7), a pressure sensor (266A), and a fluid pathway including a reservoir configured to receive a fluid (252), a pump (the elastomer which surrounds the 252 vessel and contracts to force/pump the fluid out; page 3, para. [0032], sentence 1), and a fluid line downstream of the pump (Fig. 3: fluid line 262), the computer program product comprising at least one non-transitory computer-readable medium including program instructions (page 6, para. [0053], sentence 1; instructions programmed into microcontrollers of unit 120) that, when executed by the microcontroller, cause the microcontroller to: control the pressure sensor to measure a pressure in the fluid pathway (page 6, para. [0053], sentence 1; Fig. 6: page 4, para. [0039], sentences 6-7); receive the pressure measured in the fluid pathway (page 6, para. [0053], sentence 1; Fig. 6: page 4, para. [0039], sentences 6-7); determine, based on the pressure measured in the fluid pathway, whether the reservoir is empty of the fluid (page 1, para. [0011], sentences 3-4); and control an output device to provide an indication associated with the determination of whether the reservoir is empty of the fluid (page 1, para. [0011], sentences 3-4; page 6, para. [0054], last sentence). However, Gravesen discloses the pump and reservoir, as described above, as a single unit, and fails to disclose the pump being downstream of the reservoir. Gravesen also fails to disclose a dosing chamber in association with the reservoir and pump.
Carter teaches an analogous drug delivery device configured to determine when the reservoir is empty, with a pump (Fig. 7: pump 172) downstream of the reservoir (Fig. 7: pump 172 is downstream of reservoir 180). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Gravesen drug delivery device by replacing the Gravesen pump/reservoir (252) with the reservoir and downstream pump with the integrated valve mechanisms taught by Carter (as depicted in the annotated figure below), in order to incorporate the precise and consistent dosing mechanism created by the pump/valve mechanism of Carter (Figs. 7 and 8: page 4, para. [0054], sentences 3-6; page 4, para. [0055], sentence 3).
The analogous drug delivery device of Carter further teaches that wherein the pump includes a dosing chamber (170) and wherein the pump is caused to cyclically (i) pump the reservoir with the dosing chamber in fluid communication with the reservoir and not in fluid communication with the fluid line (Fig. 7: the positioning of shuttle valve 210 seals off the fluid line at 125/130, creating fluid communication between 180 and 172 depicted by the arrows, and no fluid communication between 172 and 125/130) and (ii) fluidically connect with the dosing chamber not in fluid communication with the reservoir, the dosing chamber with the fluid line (Fig. 8: the positioning of shuttle valve 210 seals off the reservoir 180, creating fluid communication between 172 and 125/130 depicted by the arrows, and no fluid communication between 172 and 180). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have also incorporated the dosing chamber of the Carter pump into the Gravesen drug delivery device upon the combination described above, in order to ensure that precise amounts of the fluid are being administered with each cycle of the pump (Carter: para. [0054], second-to-last sentence). Upon this combination, described above and depicted in the annotated figure below, it would directly follow that the measuring of the pressure by the pressure sensor in the fluid pathway (and subsequent receiving and determining based on this measuring), taught by Gravesen, would occur with the dosing chamber not in fluid communication with the reservoir and the dosing chamber fluidically connected with the fluid line (Carter: Fig. 8: the positioning of shuttle valve 210 seals off the reservoir 180, creating fluid communication between 172 and 125/130 depicted by the arrows, and no fluid communication between 172 and 180; page 5, para. [0063], sentences 6-8), since the fluid is pumped through and flows through the fluid line when the dosing chamber is fluidically connected with the fluid line, at which point the sensor measures the pressure of that fluid moving through the fluid line.
Regarding claim 18, Gravesen in view of Carter teaches the computer program product of claim 17, as described above, wherein the microcontroller controls the pressure sensor to measure the pressure in the fluid pathway downstream of the pump (Gravesen: sensor 266A downstream of pump at 252; page 6, para. [0053], sentence 1; Fig. 6: page 4, para. [0039], sentences 6-7).
Regarding claim 20, Gravesen in view of Carter teaches the computer program product of claim 17, as described above, wherein the microcontroller controls the pressure sensor to measure the pressure in the fluid pathway upstream of the pump (Carter: pressure sensor upstream of pump 172; page 2, para. [0013], last sentence; Gravesen: page 6, para. [0053], sentence 1; Fig. 6: page 4, para. [0039], sentences 6-7).
Response to Arguments
Applicant's arguments filed 10/29/2025 with respect to the prior art rejections have been fully considered but they are not persuasive.
Applicant argues that Gravesen fails to disclose that the pressure is measured when the dosing chamber is not in fluid communication with the reservoir and is fluidically connected with the fluid line, as claimed. Applicant further argues that the dosing chamber taught by Carter in the combination used in the rejections above is in contrast to the claimed limitations, as the dosing chamber is cyclically filled and emptied. However, Examiner interprets this combination of Gravesen in view of Carter to teach all the claimed limitations of the pressure measurements being obtained (and subsequently received and determined) as being fulfilled at all points of the claimed configurations wherein the dosing chamber is/is not in fluid communication with the reservoir and/or fluid line. In other words, because the dosing chamber taught by Carter operates cyclically and quickly, and is structured such that the dosing chamber is ever only in fluid communication with either the reservoir or the fluid line, it directly follows that the pressure measurements can be and are obtained when the dosing chamber is not in fluid communication with the reservoir and is fluidically connected with the fluid line, as this is when the fluid is pushed through the line. Furthermore, Examiner relies upon the combination of Gravesen in view of Carter, as described in the rejections above, to teach these limitations, and not on either Gravesen or Carter alone, as seems to be argued by Applicant in the Remarks.
For these reasons, claims 1-5, 7-13, 15-18 and 20 stand rejected as recited above, given the combination of Gravesen in view of Carter depicted in the annotated figure above.
Conclusion
THIS ACTION IS MADE FINAL. 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 KATERINA ANNA WITTLIFF whose telephone number is (703)756-4772. The examiner can normally be reached M-Th: 9-7ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, MICHAEL TSAI can be reached at 571-270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/K.A.W./Examiner, Art Unit 3783
/NATHAN R PRICE/Primary Examiner, Art Unit 3783