Prosecution Insights
Last updated: July 17, 2026
Application No. 17/628,996

DRUG SOLUTION INJECTION CONTROLLER

Final Rejection §103
Filed
Jan 21, 2022
Priority
Jul 22, 2019 — JP 2019-134453 +1 more
Examiner
GONZALEZ, LEI NMN
Art Unit
3783
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
NIPRO Corporation
OA Round
4 (Final)
47%
Grant Probability
Moderate
5-6
OA Rounds
0m
Est. Remaining
99%
With Interview

Examiner Intelligence

Grants 47% of resolved cases
47%
Career Allowance Rate
9 granted / 19 resolved
-22.6% vs TC avg
Strong +58% interview lift
Without
With
+57.8%
Interview Lift
resolved cases with interview
Typical timeline
3y 10m
Avg Prosecution
34 currently pending
Career history
67
Total Applications
across all art units

Statute-Specific Performance

§103
70.7%
+30.7% vs TC avg
§102
18.0%
-22.0% vs TC avg
§112
10.2%
-29.8% vs TC avg
Black line = Tech Center average estimate • Based on career data from 19 resolved cases

Office Action

§103
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 Claims This office action is responsive to the amendment filed 27 January 2026. Claim 6 is canceled. Claims 1, 3, 5, and 7 are amended. Claims 1-5 and 7 are presently pending in this application. 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. Claims 1 and 2 are rejected under 35 U.S.C. 103 as being unpatentable over Mabrey et al. (US Patent Publication No. 20040127860 A1), hereinafter Mabrey, in view of Gagliardoni et al. (US Patent No. 8,551,057 B2), hereinafter Gagliardoni, in further view of Vogelbaum (US Patent Publication No. 20220047805 A1). Regarding claim 1, Mabrey discloses a drug solution injection controller (Mabrey: Fig. 1-6, device 10) including a sub-reservoir (Fig. 4 and 5, closed reservoir 22) connected via a sub-line (Fig. 4 and 5, inlet port 28) to a main line (Fig. 4-6, section of inlet conduit 32 external of device 10) for performing continuous administration of a drug solution (para. 0013) such that rapid administration of the drug solution from the sub-reservoir (Fig. 4 and 5, closed reservoir 22) by self-operation is enabled (plunger 48 is operated by patient; para. 0043-0045 and 0051), the drug solution injection controller ( Fig. 1-6, device 10) comprising: a limiting flow path (Fig. 4, bypass conduit 74) and a priming flow path (Fig. 7, inlet conduit 32 and loop 35; para. 0050) provided in the sub-line (Fig. 4, inlet conduit 32 is provided within the inlet port 28), the priming flow path (Fig. 7, inlet conduit 32 and loop 35) bypassing the limiting flow path (Fig. 4, the inlet conduit 32 bypasses the conduit 74 when clamp 38 prevents flow through the flow path; para. 0051), with the priming flow path (Fig. 7, inlet conduit 32 and loop 35) configured to perform priming on at least one of the main line (Fig. 4-6, section of inlet conduit 32 external of device 10) and the sub-line (Fig. 4 and 5, inlet port 28 and inlet conduit 32 are primed; para. 0050); a closing valve (Fig. 7, clamp 38) configured to close the priming flow path (Fig. 7, clamp 38 stops priming by closing loop 35; para. 0050); and an operation switch (Fig. 9, ledge 56; para. 0044) configured to activate the closing valve (Fig. 9, ledge 56 engages clamp 38 to move it to an open position; para. 0044), an inflow line (Fig. 4-6, section of inlet conduit 32 that is inside device 10) and an outflow line (Fig. 4-6, section of outlet conduit 34) are connected to the sub-reservoir (Fig. 4-6, reservoir 22 is connected inlet conduit 32 and outlet conduit 34 via inlet port 28 and outlet port 30 respectively), an open-close valve (Fig. 2, tubing clamp 73) is provided on the outflow line (Fig. 2, clamp 73 is on outlet conduit 34), and with the priming flow path (Fig. 7, inlet conduit 32 and loop 35; para. 0050) being closed by the closing valve (Fig. 7, clamp 38 stops priming by closing loop 35; para. 0050), the open-close valve (Fig. 2, tubing clamp 73) is moved from a closed position to an open position by the self-operation (clamp 73 is used to control flow of liquid through device; para. 0050) so that the drug solution stored in the sub-reservoir is rapidly administered through the outflow line (clamp 73 is used to control flow of liquid through device; para. 0050), wherein the closing valve (Fig. 7, clamp 38) is configured such that in an open position (Fig. 7), the closing valve (Fig. 7, clamp 38) permits filling of the sub-line (Fig. 4 and 5, inlet port 28) and the sub-reservoir (Fig. 4 and 5, closed reservoir 22) with a priming fluid through the priming flow path (in an open position, clamp 38 permits filling through the inlet port 28 and closed reservoir 22; para. 0049-0050), and in a closed position (Fig. 9), the closing valve (Fig. 7, clamp 38) closes the priming flow path (Fig. 7, inlet conduit 32 and loop 35; para. 0050) so that the drug solution is supplied through the limiting flow path (Fig. 4, conduit 74) to the sub-reservoir (when clamp 38 is closed, drug solution is supplied through conduit 74; para. 0051). Mabrey does not expressly disclose a connector holding part holding a terminal connector connected to the main line, wherein holding of the terminal connector by the connector holding part is allowed to be released due to operation of the operation switch. Gagliardoni teaches a connector holding part (Gagliardoni: Fig. 8, cassette 1) holding a terminal connector (Fig. 8, connector 6 is attached to tube 10, which is held by cassette 1) connected to a main line (Fig. 8, tube 10), wherein holding of the terminal connector (Fig. 8, connector 6) by the connector holding part (Fig. 8, connector 6 is attached to tube 10, which is held by cassette 1) is allowed to be released due to operation of an operation switch (Fig. 8, clamping element 7 can be brought from a closed to an open position by disengaging first locking means 23 and second locking means 25; col 6, ln 57-67 – col 7, ln 1-9). It would have been obvious to one of ordinary skill in the art before the effective filing date to add the connector holding part of Gagliardoni to the injection controller of Mabrey, wherein holding of the terminal connector by the connector holding part of Gagliardoni is allowed to be released due to operation of the operation switch of Mabrey configured to activate the closing valve in order to allow for a tidy and compact design of the injection controller assembly which makes the use of the infusion set easier for medical personnel (Gagliardoni: col 4, ln 50-56). Mabrey in view of Gagliardoni does not expressly disclose the priming flow path having a flow path cross-sectional area larger than that of the limiting flow path. Vogelbaum teaches a limiting flow path (Vogelbaum: Fig. 2C, one of delivery tubes 106, all of which can have varying internal diameters and flow rates; para. 0020 and para. 0074) which branch a sub-line (Fig. 2C, input line 102), a different flow path (Fig. 2C, one of delivery tubes 106) having a flow path cross-sectional area larger than that of the limiting flow path (delivery tubes 106 can have varying internal diameters; para. 0020). It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the sub-line and priming flow path of Mabrey in view of Gagliardoni such that the priming flow path having a flow path cross-sectional area larger than that of the limiting flow path as taught by Vogelbaum in order to allow for an input line to provide varying flow rates (Vogelbaum: para. 0020). Mabrey in view of Gagliardoni and Vogelbaum does not expressly disclose Regarding claim 2, Mabrey in view of Gagliardoni and Vogelbaum discloses the drug solution injection controller above. Mabrey in view of Vogelbaum does not expressly disclose the connector holding part is coupled to a holding member separate from the operation switch, and holding of the terminal connector by the connector holding part is allowed to be released by operation of the holding member due to operation of the operation switch. Gagliardoni teaches a connector holding part (Gagliardoni: Fig. 8, cassette 1) is coupled to a holding member (Fig. 8, holding means 3) separate from an operation switch (Mabrey: Fig. 9, ledge 56; para. 0044), and holding of a terminal connector (Fig. 8, connector 6) by a connector holding part (Fig. 8, connector 6 is attached to tube 10, which is held by cassette 1) is allowed to be released due to operation of an operation switch (Fig. 8, clamping element 7 can be brought from a closed to an open position by disengaging first locking means 23 and second locking means 25; col 6, ln 57 – col 7, ln 9). It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device of Mabrey in view of Vogelbaum such that the connector holding part is coupled to a holding member separate from the operation switch, and holding of the terminal connector by the connector holding part is allowed to be released by operation of the holding member due to operation of the operation switch as taught by Gagliardoni in order to allow for a tidy and compact design of the injection controller assembly which makes the use of the infusion set easier for medical personnel (Gagliardoni: col 4, ln 50-56). Claims 3 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Mabrey in view of Vogelbaum. Regarding claim 3, Mabrey teaches a drug solution injection controller (Mabrey: Fig. 1-6, device 10) including a sub-reservoir (Fig. 4 and 5, closed reservoir 22) connected via a sub-line (Fig. 4 and 5, inlet port 28) to a main line (Fig. 4-6, section of inlet conduit 32 external of device 10) for performing continuous administration of a drug solution (para. 0013) such that rapid administration of the drug solution from the sub-reservoir (Fig. 4 and 5, closed reservoir 22) by self-operation is enabled (plunger 48 is operated by patient; para. 0043-0045 and 0051), the drug solution injection controller ( Fig. 1-6, device 10) comprising: a limiting flow path (Fig. 4, bypass conduit 74) and a priming flow path (Fig. 7, inlet conduit 32 and loop 35; para. 0050) provided in the sub-line (Fig. 4, inlet conduit 32 is provided within the inlet port 28), the priming flow path (Fig. 7, inlet conduit 32 and loop 35) bypassing the limiting flow path (Fig. 4, the inlet conduit 32 bypasses the conduit 74 when clamp 38 prevents flow through the flow path; para. 0051), with the priming flow path (Fig. 7, inlet conduit 32 and loop 35) configured to perform priming (Fig. 4-6, section of inlet conduit 32 external of device 10); a closing valve (Mabrey: Fig. 7, comprised of clamp 38, wedge 42, spring 40, and extension 58) configured to close the priming flow path (Mabrey: Fig. 7, clamp 38 stops priming by closing loop 35; para. 0050); an operation switch (Mabrey: Fig. 9, clamp 38; para. 0044) configured to activate the closing valve (Mabrey: Fig. 9, ledge 56 engages clamp 38 to move it to an open position; para. 0044); and a tab member (Mabrey: Fig. 7 and 8, comprised of priming tab 66, aperture 68, and wedge-shaped jaw 42 of claim 38; para. 0048) preventing operation of the operation switch (Mabrey: Fig. 7 and 8, priming tab 66 engages with wedge-shaped jaw 42 and holds clamp 38 in an open position regardless of button operation; para. 0048) configured to activate the closing valve (Mabrey: Fig. 9, ledge 56 engages clamp 38 to move it to an open position; para. 0044), wherein activation of the closing valve (Mabrey: Fig. 7, clamp 38) by operation of the operation switch (Mabrey: Fig. 9, ledge 56 engages clamp 38 to move it to an open position; para. 0044) is allowed due to release of the tab member (Mabrey: Fig. 7 and 8, priming tab 66 is removable, allowing movement of clamp 38; para. 0048), an inflow line (Fig. 4-6, section of inlet conduit 32 that is inside device 10) and an outflow line (Fig. 4-6, section of outlet conduit 34) are connected to the sub-reservoir (Fig. 4-6, reservoir 22 is connected inlet conduit 32 and outlet conduit 34 via inlet port 28 and outlet port 30 respectively), an open-close valve (Fig. 2, tubing clamp 73) is provided on the outflow line (Fig. 2, clamp 73 is on outlet conduit 34), and with the priming flow path (Fig. 7, inlet conduit 32 and loop 35; para. 0050) being closed by the closing valve (Fig. 7, clamp 38 stops priming by closing loop 35; para. 0050), the open-close valve (Fig. 2, tubing clamp 73) is movable from a closed position to an open position (clamp 73 is used to control flow of liquid through device; para. 0050) so that the drug solution stored in the sub-reservoir is rapidly administered through the outflow line (clamp 73 is used to control flow of liquid through device; para. 0050) wherein the closing valve (Fig. 7, clamp 38) is configured such that in an open position (Fig. 7), the closing valve (Fig. 7, clamp 38) permits filling of the sub-line (Fig. 4 and 5, inlet port 28) and the sub-reservoir (Fig. 4 and 5, closed reservoir 22) with a priming fluid through the priming flow path (in an open position, clamp 38 permits filling through the inlet port 28 and closed reservoir 22; para. 0049-0050), and in a closed position (Fig. 9), the closing valve (Fig. 7, clamp 38) closes the priming flow path (Fig. 7, inlet conduit 32 and loop 35; para. 0050) so that the drug solution is supplied through the limiting flow path (Fig. 4, conduit 74) to the sub-reservoir (when clamp 38 is closed, drug solution is supplied through conduit 74; para. 0051). Mabrey does not expressly disclose a limiting flow path provided in parallel with the priming flow path which branch the sub-line, the priming flow path having a flow path cross-sectional area larger than that of the limiting flow path. Vogelbaum teaches a limiting flow path (Vogelbaum: Fig. 2C, one of delivery tubes 106, all of which can have varying internal diameters and flow rates; para. 0020 and para. 0074) provided in parallel with another flow path (Fig. 2C, delivery tubes 106 run in parallel with one another) which branch a sub-line (Fig. 2C, input line 102), the other flow path (Fig. 2C, one of delivery tubes 106) having a flow path cross-sectional area larger than that of the limiting flow path (delivery tubes 106 can have varying internal diameters; para. 0020). It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the sub-line and priming flow path of Mabrey such that a limiting flow path is provided in parallel with the priming flow path which branch the sub-line, the priming flow path having a flow path cross-sectional area larger than that of the limiting flow path as taught by Vogelbaum in order to allow for an input line to provide varying flow rates (Vogelbaum: para. 0020). Regarding claim 4, Mabrey in view of Vogelbaum teaches the drug solution injection controller above, wherein the tab member (Mabrey: Fig. 7 and 8, comprised of priming tab 66, aperture 68, and wedge-shaped jaw 42 of claim 38; para. 0048) is separate from and releasably attached to the operation switch (Mabrey: Fig. 7 and 8, priming tab 66 is removable and is therefore separate from the clamp 38; para. 0048) (Mabrey: Fig. 7, priming tab 66 engages with wedge-shaped jaw 42; para. 0048). PNG media_image1.png 914 710 media_image1.png Greyscale Claims 5 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Valle et al. (US Patent No. 8,308,688), hereinafter Valle, in view of Vogelbaum. Regarding claim 5, Valle teaches a drug solution injection controller (Valle: Fig. 1, 2, 6-13, 15-17, device 10) including a sub-reservoir (Valle: Fig. 6, 7. and 17, closed reservoir 22) connected via a sub-line (Valle: Fig. 6, 7. and 17, inlet port 28) to a main line (Valle: Fig. 6-8, and 17, section of inlet conduit 32 external of device 10) for performing continuous administration of a drug solution (Valle: col 2, ln 34-40) such that rapid administration of the drug solution from the sub-reservoir (Valle: Fig. 6, 7. and 17, closed reservoir 22) by self-operation is enabled (Valle: plunger 48 is operated by patient; col 8, ln 20-37), the drug solution injection controller (Valle: Fig. 1, 2, 6-13, 15-17, device 10) comprising: a limiting flow path (Fig. 6, bypass conduit 76) and a priming flow path (Valle: Fig. 6-8, and 17, inlet conduit 32 and loop 35; col 11, ln 38-57) provided in the sub-line (Fig. 6-8, conduit 32 is provided in inlet port 28), the priming flow path (Fig. 6-8 and 17, conduit 32 and loop 35) bypassing the limiting flow path (Fig. 6, the inlet conduit 32 bypasses the conduit 74), with the priming flow path configured to perform priming (Valle: Fig. 6, 7. and 17, inlet port 28 and inlet conduit 32 are primed; col 11, ln 38-57); a closing valve (Valle: Fig. 9, comprised of clamp 38, wedge 42, spring 40, and extension 58) configured to close the priming flow path (Valle: Fig. 7, clamp 38 stops priming by closing loop 35; col 11, ln 38-57); an operation switch (Valle: Fig. 9, clamp 38; col 11, ln 38-57) configured to activate the closing valve (Valle: Fig. 9, ledge 56 engages clamp 38 to move it to an open position; col 8, ln 58-67 – col 9, ln 1-6); a tab member (Fig. 17, priming tab 166) comprising a display part (Valle: Fig. 17 shown above, display part A) displaying priming-related information (Fig. 17 shown above, display part A displays an arrow indicating direction for pulling for the purposes of priming; col 4, ln 1-11), and being configured to releasably couple (Fig. 17 shown above, display part A of priming tab 166 is inserted into place, and can be removed and discarded from device 10 to engage clamp 38; col 11, ln 38-57) to the operation switch, wherein operation of the operation switch (Valle: Fig. 9, clamp 38; col 8, ln 58-67 – col 9, ln 1-6) to activate the closing valve (Valle: Fig. 9, ledge 56 engages clamp 38 to move it to an open position; col 8, ln 58-67 – col 9, ln 1-6) also allows the display part (Valle: Fig. 17 shown above, display part A) of the tab member (Fig. 17, priming tab 166) to be obscured by removal (Fig. 17 shown above, display part A of priming tab 166 is removed and discarded from device 10 to engage clamp 38, thus becoming no longer visible; col 11, ln 38-57), an inflow line (Fig. 6-8, section of inlet conduit 32 that is inside device 10) and an outflow line (Fig. 6-8, outlet conduit 34) are connected to the sub-reservoir (Fig. 6-8, reservoir 22 is connected inlet conduit 32 and outlet conduit 34 via inlet port 28 and outlet port 30 respectively), an open-close valve (Fig. 2, tubing clamp 73) is provided on the outflow line (Fig. 2, clamp 73 is on outlet conduit 34), and with the priming flow path (Fig. 9, inlet conduit 32 and loop 35; col 11, ln 38-57) being closed by the closing valve (Fig. 9, clamp 38 stops priming by closing loop 35; para. 0050), the open-close valve (Fig. 2, tubing clamp 73) is movable from a closed position to an open position (clamp 73 is used to control flow of liquid through device; col 11, ln 38-57) so that the drug solution stored in the sub-reservoir is rapidly administered through the outflow line (clamp 73 is used to control flow of liquid through device; col 11, ln 38-57), wherein the closing valve (Fig. 9, clamp 38) is configured such that in an open position (Fig. 9), the closing valve (Fig. 9, clamp 38) permits filling of the sub-line (Valle: Fig. 6, 7. and 17, inlet port 28) and the sub-reservoir (Valle: Fig. 6, 7. and 17, closed reservoir 22) with a priming fluid through the priming flow path (in an open position, clamp 38 permits filling through the inlet port 28 and closed reservoir 22; col 7, ln 8-26), and in a closed position (Fig. 12), the closing valve (Fig. 9, clamp 38) closes the priming flow path (Valle: Fig. 6-8, and 17, inlet conduit 32 and loop 35; col 11, ln 38-57) so that the drug solution is supplied through the limiting flow path (Fig. 6, bypass conduit 76) to the sub-reservoir (when clamp 38 is closed, drug solution is supplied through conduit 74; col 11, ln 58 – col 12, ln 2). It would have been an obvious matter of design choice to make the different portions of the display part of Valle of whatever form or shape was desired or expedient, including, but not limited to, an information display function for priming-related information. A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47. Valle does not expressly disclose the priming flow path having a flow path cross-sectional area larger than that of the limiting flow path. Vogelbaum teaches a limiting flow path (Vogelbaum: Fig. 2C, one of delivery tubes 106, all of which can have varying internal diameters and flow rates; para. 0020 and para. 0074) which branch a sub-line (Fig. 2C, input line 102), the other flow path (Fig. 2C, one of delivery tubes 106) having a flow path cross-sectional area larger than that of the limiting flow path (delivery tubes 106 can have varying internal diameters; para. 0020). It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the sub-line and priming flow path of Valle such that the priming flow path having a flow path cross-sectional area larger than that of the limiting flow path as taught by Vogelbaum in order to allow for an input line to provide varying flow rates (Vogelbaum: para. 0020). Regarding claim 7, Valle discloses a drug solution injection controller (Valle: Fig. 1, 2, 6-13, 15-17, device 10) including a sub-reservoir (Valle: Fig. 6, 7. and 17, closed reservoir 22) connected via a sub-line (Valle: Fig. 6, 7. and 17, inlet port 28) to a main line (Valle: Fig. 6-8, and 17, section of inlet conduit 32 external of device 10) for performing continuous administration of a drug solution (Valle: col 2, ln 34-40) such that rapid administration of the drug solution from the sub-reservoir (Valle: Fig. 6, 7. and 17, closed reservoir 22) by self-operation is enabled (Valle: plunger 48 is operated by patient; col 8, ln 20-37), the drug solution injection controller (Valle: Fig. 1, 2, 6-13, 15-17, device 10) comprising: a limiting flow path (Fig. 6, bypass conduit 76) and a priming flow path (Valle: Fig. 6-8, and 17, inlet conduit 32 and loop 35; col 11, ln 38-57) provided in the sub-line (Fig. 6-8, conduit 32 is provided in inlet port 28), the priming flow path (Fig. 6-8 and 17, conduit 32 and loop 35) bypassing the limiting flow path (Fig. 6, the inlet conduit 32 bypasses the conduit 74), with the priming flow path configured to perform priming (Valle: Fig. 6, 7. and 17, inlet port 28 and inlet conduit 32 are primed; col 11, ln 38-57); a closing valve (Valle: Fig. 9, comprised of clamp 38, wedge 42, spring 40, and extension 58) configured to close the priming flow path (Valle: Fig. 7, clamp 38 stops priming; col 11, ln 38-57); and a display part (Valle: Fig. 17 shown above, display part A) displaying priming-related information including operation information of the closing valve (Fig. 17 shown above, display part A displays an arrow indicating direction for pulling), an inflow line (Fig. 6-8, section of inlet conduit 32 that is inside device 10) and an outflow line (Fig. 6-8, outlet conduit 34) are connected to the sub-reservoir (Fig. 6-8, reservoir 22 is connected inlet conduit 32 and outlet conduit 34 via inlet port 28 and outlet port 30 respectively), an open-close valve (Fig. 2, tubing clamp 73) is provided on the outflow line (Fig. 2, clamp 73 is on outlet conduit 34), and with the priming flow path (Fig. 9, inlet conduit 32 and loop 35; col 11, ln 38-57) being closed by the closing valve (Fig. 9, clamp 38 stops priming by closing loop 35; para. 0050), the open-close valve (Fig. 2, tubing clamp 73) is moved from a closed position to an open position by the self-operation (clamp 73 is used to control flow of liquid through device; col 11, ln 38-57) so that the drug solution stored in the sub-reservoir is rapidly administered through the outflow line (clamp 73 is used to control flow of liquid through device; col 11, ln 38-57), wherein the closing valve (Fig. 9, clamp 38) is configured such that in an open position (Fig. 9), the closing valve (Fig. 9, clamp 38) permits filling of the sub-line (Valle: Fig. 6, 7. and 17, inlet port 28) and the sub-reservoir (Valle: Fig. 6, 7. and 17, closed reservoir 22) with a priming fluid through the priming flow path (in an open position, clamp 38 permits filling through the inlet port 28 and closed reservoir 22; col 7, ln 8-26), and in a closed position (Fig. 12), the closing valve (Fig. 9, clamp 38) closes the priming flow path (Valle: Fig. 6-8, and 17, inlet conduit 32 and loop 35; col 11, ln 38-57) so that the drug solution is supplied through the limiting flow path (Fig. 6, bypass conduit 76) to the sub-reservoir (when clamp 38 is closed, drug solution is supplied through conduit 74; col 11, ln 58 – col 12, ln 2). It would have been an obvious matter of design choice to make the different portions of the display part of Valle of whatever form or shape was desired or expedient, including, but not limited to, an information display function for priming-related information as well as operation information of the closing valve. A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47. Valle does not expressly disclose a limiting flow path provided in parallel with the priming flow path which branch the sub-line, the priming flow path having a flow path cross-sectional area larger than that of the limiting flow path. Vogelbaum teaches a limiting flow path (Vogelbaum: Fig. 2C, one of delivery tubes 106, all of which can have varying internal diameters and flow rates; para. 0020 and para. 0074) provided in parallel with another flow path (Fig. 2C, delivery tubes 106 run in parallel with one another) which branch a sub-line (Fig. 2C, input line 102), the other flow path (Fig. 2C, one of delivery tubes 106) having a flow path cross-sectional area larger than that of the limiting flow path (delivery tubes 106 can have varying internal diameters; para. 0020). It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the sub-line and priming flow path of Valle such that a limiting flow path is provided in parallel with the priming flow path which branch the sub-line, the priming flow path having a flow path cross-sectional area larger than that of the limiting flow path as taught by Vogelbaum in order to allow for an input line to provide varying flow rates (Vogelbaum: para. 0020). Response to Arguments Applicant’s arguments, see page 6-14, filed 27 January 2026, with respect to the rejections of claims 1-5 and 7 under 35 USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new grounds of rejection is made in view of an alternative interpretation of Mabrey cited above. Conclusion Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a). A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action. Any inquiry concerning this communication or earlier communications from the examiner should be directed to LEI GONZALEZ whose telephone number is (703)756-5908. The examiner can normally be reached 7:30am - 4:00pm (CT). 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, Chelsea Stinson can be reached at (571) 270-1744. 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. /LEI GONZALEZ/Examiner, Art Unit 3783 /CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783
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Prosecution Timeline

Show 2 earlier events
Jan 13, 2025
Non-Final Rejection mailed — §103
Apr 11, 2025
Response Filed
Jul 01, 2025
Final Rejection mailed — §103
Oct 01, 2025
Request for Continued Examination
Oct 03, 2025
Response after Non-Final Action
Oct 27, 2025
Non-Final Rejection mailed — §103
Jan 27, 2026
Response Filed
Jun 17, 2026
Final Rejection mailed — §103 (current)

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Prosecution Projections

5-6
Expected OA Rounds
47%
Grant Probability
99%
With Interview (+57.8%)
3y 10m (~0m remaining)
Median Time to Grant
High
PTA Risk
Based on 19 resolved cases by this examiner. Grant probability derived from career allowance rate.

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