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 06/15/2026 have been entered.
Claims 1, 9 and 18 have thereby been amended.
Claims 1-2, 4-6, 8-10, 13, 15-21, 26-28 and 30 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.
Claims 1-2, 4, 8-10, 13, 15, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Song (CN 109846716) in view of Fu (CN 102114279) in further view of Li (US 20190160227) in further view of Zhao (US 20090112155).
Regarding claim 1, Song discloses a drug delivery device for delivering a medicament, comprising: a housing (see annotated Fig. 16 below); a pump (Fig. 14: 1) coupled with the housing; a drive component (34) for driving the pump; an inlet fluid path (Fig. 14: 11 and 12, and see annotated Fig. 14 below) configured to deliver medicament to the pump; an outlet fluid path (see annotated Fig. 14 below) configured to receive medicament from the pump; an outlet pressure sensor positioned along the outlet fluid path and configured to measure outlet fluid pressure in the outlet fluid path (33; translation: page 11, para. 4); and a controller (8) workingly coupled with the outlet pressure sensor, and the drive component, wherein the controller is configured to adjust at least one parameter of the drive component based on input information received from the outlet pressure sensor to maintain an intended flowrate of medicament delivery (Translation: page 12, paras. 1 and 2; “If the sensor output is that the cleaning fluid spool is closed and the nutrient fluid spool is opened…the control pump wheel 34 is rotated to realize the infusion of the nutrient solution…the spool is opened, the pump wheel is controlled to rotate to realize the infusion of the nutrient solution”).
However, Song fails to disclose a second pressure sensor on the inlet fluid path, or the real-time continuous monitoring and adjustments of the flowrate.
Fu teaches an analogous drug delivery pump with an inlet pressure sensor positioned along the inlet fluid path and configured to measure inlet fluid pressure in the inlet fluid path (40) as well as an outlet pressure sensor (80); a controller (50) workingly coupled with the inlet pressure sensor (Fig. 2 connections); wherein the controller is configured to adjust at least one parameter of the drive component (30) based on input information received from the inlet pressure sensor and/or the outlet pressure sensor (Translation: page 3, para. [0020]). Therefore, 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 Song device with the inlet pressure sensor taught by Fu in order to detect occlusions in the tubing of the device to avoid blockages, treatment delays, and improve the overall safety of the infusion (Translation: page 2, paras. [0012]-[0013]). However, Song-Fu fails, still, to explicitly disclose the real-time continuous monitoring and adjustments of the flowrate.
Li teaches an analogous drug delivery pump system wherein the controller is configured to adjust at least one parameter of the drive component in real time based on continuous monitoring of input information received from the outlet pressure sensor to maintain an intended flowrate of medicament delivery (para. [0020], sentence 2; paras. [0116]-[0117]; para. [0084], sentence 4). 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 Song-Fu device by incorporating this teaching of Li, such that the sensors of Song perform continuous monitoring and causes the controller to adjust the flow rate parameters in real-time, in order to make the medicament delivery more accurate, and eliminate the need for a user to intervene to manually change the pump parameters and eliminate that associated extra time, effort, and possible error.
Although Li in the Song-Fu-Li combination does not explicitly teach that the continuous adjustments of parameters is done in order to maintain an accuracy of delivery of at least 95%, Song verifies that the medicament is delivered at a dosage as intended. The controller is therefore configured to deliver at an accuracy rate according to its programming that is at least 95% (i.e. from controller’s perspective it’s operating as intended). Therefore, under broadest reasonable interpretation, the modified device of Song meets the claimed limitation, since there is no specificity with regards to how the accuracy rate is determined. Additionally, Zhao teaches the obviousness of this, as it teaches an analogous drug delivery device wherein the controller is configured to deliver the medicament at an accuracy rate of at least 95% (para. [0022], sentence 2, teaching a delivery accuracy rate of 99.5%, given the understanding that 100% delivery is intended) as a result of adjusting the at least one parameter of the drive component based on the input information received from the inlet pressure sensor and/or the outlet pressure sensor (para. [0022], sentences 3-6). 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 incorporated the explicit accuracy rate teachings of Zhao into the Song-Fu-Li combination, such that the parameter adjustments performed as a result of the sensor data is done so to ensure a high accuracy of the drug delivery is maintained, to ensure the effectiveness of the patient treatment.
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Annotated Fig. 14, Song
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Regarding claim 2, Song in view of Fu in further view of Li in further view of Zhao teaches the drug delivery device as in claim 1, as described above, wherein the controller is configured to detect (a) an occlusion event based on the input information received from the inlet pressure sensor and/or the outlet pressure sensor (Fu Translation: page 2, para. [0012]).
Regarding claim 4, Song in view of Fu in further view of Li in further view of Zhao teaches the drug delivery device as in claim 1, as described above, further comprising a pump manifold (see annotated Fig. 16 above) supporting at least a portion of the inlet fluid path and at least a portion of the outlet fluid path; wherein the inlet pressure sensor and/or the outlet pressure sensor are supported by the pump manifold (Song Fig. 14: 33 supported in manifold).
Regarding claim 8, Song in view of Fu in further view of Li in further view of Zhao teaches the drug delivery device as in claim 1, as described above, wherein the at least one parameter of the drive component is the speed of the drive component (Fu Translation: page 2, para. [0012] and page 3, para. [0020]; drive speed goes to zero to stop the transfusion).
Regarding claim 9, Song in view of Fu in further view of Li in further view of Zhao teaches the drug delivery device as in claim 1, as described above, further comprising: a medicament container (Song Fig. 14: 13 and 14) containing a medicament; wherein the inlet fluid path is further configured to receive the medicament from the medicament container (see annotated Fig. 14 above); wherein the outlet fluid path is further configured to deliver the medicament to a patient (Song Translation: page 9, sixth paragraph).
Regarding claim 10, Song in view of Fu in further view of Li in further view of Zhao teaches the drug delivery device as in claim 9, as described above, wherein the drug delivery device defines a boundary between the inlet fluid path and the outlet fluid path (Song Fig. 14: boundary defined by pump wheel 34).
Regarding claim 13, Song in view of Fu in further view of Li in further view of Zhao teaches the drug delivery device as in claim 9, as described above, further comprising at least one adaptor (Song Fig. 7: 10) for fluidly connecting (a) at least two sections of the inlet fluid path with each other (Song Fig. 7: 10 connecting 113 and 114) and/or (b) at least two sections of the outlet fluid path with each other.
Regarding claim 15, Song in view of Fu in further view of Li in further view of Zhao teaches the drug delivery device as in claim 9, as described above, further comprising an IV output line (Song: 20) configured to fluidly connect with an IV connector (Song Translation: page 9, sixth paragraph).
Regarding claim 17, Song in view of Fu in further view of Li in further view of Zhao teaches the drug delivery device as in claim 9, as described above, wherein the at least one parameter of the drive component is the speed of the drive component (Fu Translation: page 2, para. [0012] and page 3, para. [0020]; drive speed goes to zero to stop the transfusion).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Song (CN 109846716) in view of Fu (CN 102114279) in further view of Li (US 20190160227) in further view of Zhao (US 20090112155) in further view of Harris (WO 2019074579).
Regarding claim 6, Song in view of Fu in further view of Li in further view of Zhao teaches the drug delivery device as in claim 1, as described above, but fails to disclose the medicament administered as a bispecific T cell engager or other artificial monoclonal antibody.
Harris teaches an analogous drug delivery pump device wherein the medicament is in the form of a bispecific T cell engager (page 23, para. [00119]), wherein the bispecific T cell engager is optionally a half-life extended bispecific T cell engager.
Therefore, 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 Song-Fu-Li combination with the administration of a bispecific T cell engager or other artificial monoclonal antibody taught by Harris, in order to administer the antibody therapy to patients, including for cancer treatment (page 16, para. [0079]).
Claims 5 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Song (CN 109846716) in view of Fu (CN 102114279) in further view of Li (US 20190160227) in further view of Zhao (US 20090112155) in further view of Estes (US 20140276536).
Regarding claim 5, Song in view of Fu in further view of Li in further view of Zhao teaches the drug delivery device as in claim 1, as described above. As the Song-Fu combination electrically transmits a signal from the pressure sensor, it is understood in the art to include some transducer. However, Song in view of Fu in further view of Li fails to explicitly teach a transducer included in the pressure sensor(s).
Estes teaches an analogous drug delivery pump device with a pressure sensor wherein the inlet pressure sensor and/or the outlet pressure sensor includes a transducer (page 10, para. [0075], first two lines).
Therefore, 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 Song-Fu-Li device with the transducer of the pressure sensor taught by Estes in order to electrically transmit the data from the pressure sensor to the controller (page 10, para. [0075]).
Regarding claim 16, Song in view of Fu in further view of Li in further view of Zhao teaches the drug delivery device as in claim 9, as described above. As the Song-Fu combination electrically transmits a signal from the pressure sensor, it is understood in the art to include some transducer. However, Song in view of Fu in further view of Li fails to explicitly teach a transducer included in the pressure sensor(s).
Estes teaches an analogous drug delivery pump device with a pressure sensor wherein the inlet pressure sensor and/or the outlet pressure sensor includes a transducer (page 10, para. [0075], first two lines).
Therefore, 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 Song-Fu-Li device with the transducer of the pressure sensor taught by Estes in order to electrically transmit the data from the pressure sensor to the controller (page 10, para. [0075]).
Claims 18-19, 21, 27, and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Song (CN 109846716) in view of Klemm (WO 2018115311) in further view of Seitz (US 20190240398) in further view of Zhao (US 20090112155).
Regarding claim 18, Song discloses a drug delivery device for delivering a medicament, comprising: a housing (see annotated Fig. 16 above); a pump (Fig. 14: 1) coupled with the housing; a drive component (34) for driving the pump; a fluid path (25) workingly coupled with the pump such that the pump is configured to urge the medicament along the fluid path (Fig. 14; Translation: page 12, para. 2)); at least one sensor configured to measure a flow parameter of the medicament along the fluid path (33); a controller (8) workingly coupled with the at least one sensor and the drive component, wherein the controller is configured to adjust at least one parameter of the drive component based on input information received from the at least one sensor to deliver medicament (Translation: page 12, paras. 1) and 2); “If the sensor output is that the cleaning fluid spool is closed and the nutrient fluid spool is opened…the control pump wheel 34 is rotated to realize the infusion of the nutrient solution…the spool is opened, the pump wheel is controlled to rotate to realize the infusion of the nutrient solution”).
However, Song fails to explicitly disclose the accuracy rate for which the medicament is delivered.
Klemm, however, teaches an analogous drug delivery pump that does teach verification of the medicament delivery (page 15, second paragraph; page 17, fourth paragraph), wherein the controller is configured to deliver the medicament in a verified manner.
Therefore, 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 Song device with the medicament delivery verification taught by Klemm in order to ensure proper and accurate delivery of the dosage as well as to ensure there is not a leak (page 15, second paragraph, last sentence; page 17, fourth paragraph) without manual checking and execution of the steps from the user (page 19, first paragraph). However, Klemm fails to explicitly teach the manner in which the calculated and measured parameters are compared in order to derive that accuracy verification.
Seitz teaches an analogous drug delivery pump that performs error detection and accuracy verification as measured by at least one of a comparison between a programmed volume of the medicament for delivery and an actual delivered volume of the medicament, a programmed weight of medicament for delivery and an actual delivered weight of medicament, a calculated volume of the medicament delivered and the actual delivered volume of the medicament, a calculated weight of the medicament delivered and the actual delivered weight of the medicament, and a programmed total time of delivery and an actual total time of delivery (para. [0012], second-to-last sentence; claim 1; the calculated/estimated completion time for the drug delivery is compared to the measured actual time of the delivery as determined by the stroke movement). 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 Song-Klemm device by incorporating the comparison of the expected and actual drug delivery times as taught by Seitz in order to measure the accuracy and potential error in the drug delivery in a simple, low cost, yet effective manner.
As a result, the modified device of Song, verifies that the medicament is delivered at a dosage as intended. The controller is therefore configured to deliver at an accuracy rate according to its programming that is at least 95% (i.e. from controller’s perspective it’s operating as intended). Therefore, under broadest reasonable interpretation, the modified device of Song meets the claimed limitation, since there is no specificity with regards to how the accuracy rate is determined. Additionally, Zhao teaches the obviousness of this, as it teaches an analogous drug delivery device wherein the controller is configured to deliver the medicament at an accuracy rate of at least 95% (para. [0022], sentence 2, teaching a delivery accuracy rate of 99.5%, given the understanding that 100% delivery is intended) as a result of adjusting the at least one parameter of the drive component based on the input information received from the inlet pressure sensor and/or the outlet pressure sensor (para. [0022], sentences 3-6). 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 incorporated the explicit accuracy rate teachings of Zhao into the Song-Klemm-Seitz combination, such that the parameter adjustments performed as a result of the sensor data is done so to ensure a high accuracy of the drug delivery is maintained, to ensure the effectiveness of the patient treatment.
Regarding claim 19, Song in view of Klemm in further view of Seitz in further view of Zhao teaches the drug delivery device as in claim 18, as described above, wherein the controller includes an encoder-fed (Klemm: 36), closed loop system (Klemm: page 19, first paragraph).
Regarding claim 21, Song in view of Klemm in further view of Seitz in further view of Zhao teaches the drug delivery device as in claim 18, as described above, wherein the controller is configured to; (a) deliver the medicament at an accuracy rate of at least 97%, (b) deliver the medicament at an accuracy rate of at least 98%, (c) deliver the medicament at an accuracy rate of at least 99%, (d) deliver the medicament at an accuracy rate of at least 97% during delivery of a dose of the medicament having a volume of at least 200 milliliters, and/or (e) deliver the medicament at an accuracy rate of at least 98% during delivery of a dose of the medicament having a volume of at least 250 milliliters.
Klemm teaches verification of the medicament delivery capable of delivering the medicament at 97%, 98%, 99%, or another percentage of accuracy. The modified device of Song, verifies that the medicament is delivered at a dosage as intended. The controller is therefore configured to deliver at an accuracy rate according to its programming that is at least 97%, 98%, or 99% (i.e. from controller’s perspective it’s operating as intended). Therefore, under broadest reasonable interpretation, the modified device of Song meets the claimed limitation, since there is no specificity with regards to how the accuracy rate is determined. This is further taught by Zhao, as described above, which teaches a delivery accuracy rate of 99.5%, given the understanding that 100% delivery is intended (Zhao: para. [0022]).
Regarding claim 27, Song in view of Klemm in further view of Seitz in further view of Zhao teaches the drug delivery device as in claim 18, as described above, further comprising: a medicament container (Song Fig. 14: 13 and 14) containing a medicament; wherein an inlet fluid path is further configured to receive the medicament from the medicament container (see annotated Fig. 14 above); wherein an outlet fluid path is further configured to deliver the medicament to a patient (Song Translation: page 9, sixth paragraph).
Regarding claim 30, Song in view of Klemm in further view of Seitz in further view of Zhao teaches the drug delivery device as in claim 27, as described above, wherein the controller includes an encoder-fed (Klemm: 36), closed loop system (Klemm: page 19, first paragraph).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Song (CN 109846716) in view of Klemm (WO 2018115311) in further view of Seitz (US 20190240398) in further view of Zhao (US 20090112155) in further view of Katsuki (EP 3231461).
Regarding claim 20, Song in view of Klemm in further view of Seitz in further view of Zhao teaches the drug delivery device as in claim 19, as described above, but fails to explicitly teach the means for which the drive speed is measured, received, and adjusted.
Katsuki teaches an analogous fluid pumping device with pump speed feedback, further comprising an encoder board for determining measured drive speed (42, col. 7, para. [0033]) and a motor model for determining a calculated drive speed (col. 4, para. [0017]; col. 8, para. [0041]); wherein the controller receives input relating to the measured drive speed and the calculated drive speed (col. 7, para. [0033]); and wherein the controller is configured to adjust the at least one parameter of the drive component based on the measured drive speed and the calculated drive speed (col. 4, para. [0017]; col. 7, para. [0033]). Therefore, 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 Song-Klemm-Seitz device by incorporating the means of measured and calculated drive speed feedback taught by Katsuki, in order to automatically and in real time adjust the drive speed for accurate fluid flow, and when applied to Song-Klemm, accurate drug delivery (col. 7, para. [0033]).
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Song (CN 109846716) in view of Klemm (WO 2018115311) in further view of Seitz (US 20190240398) in further view of Zhao (US 20090112155) in further view of Fu (CN 102114279).
Regarding claim 26, Song in view of Klemm in further view of Seitz in further view of Zhao teaches the drug delivery device as in claim 18, as described above, wherein the at least one sensor includes an outlet pressure sensor positioned along an outlet fluid path and configured to measure outlet fluid pressure (Song: 33).
However, Song in view of Klemm in further view of Seitz fails to disclose a second pressure sensor on the inlet fluid path.
Fu teaches an analogous drug delivery pump wherein the at least one sensor includes an inlet pressure sensor positioned along an inlet fluid path and configured to measure inlet fluid pressure (40). Therefore, 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 Song-Klemm-Seitz device with the inlet pressure sensor taught by Fu in order to detect occlusions in the tubing of the device to avoid blockages, treatment delays, and improve the overall safety of the infusion (Translation: page 2, paras. [0012]-[0013]).
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Song (CN 109846716) in view of Klemm (WO 2018115311) in further view of Seitz (US 20190240398) in further view of Zhao (US 20090112155) in further view of Harris (WO 2019074579).
Regarding claim 28, Song in view of Klemm in further view of Seitz in further view of Zhao teaches the drug delivery device as in claim 27, as described above, but fails to disclose the medicament administered as a bispecific T cell engager or other artificial monoclonal antibody.
Harris teaches an analogous drug delivery pump device wherein the medicament is in the form of a bispecific T cell engager (page 23, para. [00119]), wherein the bispecific T cell engager is optionally a half-life extended bispecific T cell engager.
Therefore, 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 Song-Klemm-Seitz combination with the administration of a bispecific T cell engager or other artificial monoclonal antibody taught by Harris, in order to administer the antibody therapy to patients, including for cancer treatment (page 16, para. [0079]).
Response to Arguments
Applicant’s arguments filed 06/15/2026 have been fully considered but are considered moot in light of the amendments to independent claims 1 and 18, which have newly been rejected in further view of Zhao.
Applicant argues that Song, Fu, Li and Klemm each fail to teach a drug delivery accuracy rate of at least 95% as a result of the adjusted parameters of the system. Zhao is relied upon to teach an accuracy rate of delivery maintained at within 0.5% of the target, which one of ordinary skill in the art would understand to be an intended 100% of the drug delivered to the patient. Zhao explicitly teaches that the sensors are used to control the volume of drug delivered within the target accuracy rate. Zhao further teaches sensors for occlusion detection, pressure detection, and volume detection of the reservoir that may all be used to influence how the device will respond to maintain desired delivery, especially in combination (paras. [0053] and [0054]). Song, Fu, Li and Klemm also teach adjustments of parameters based on sensor data. It would be understood that any of their taught adjusted parameters for delivery contribute to the accuracy of the drug delivered, as they all affect how much of the drug is delivered and when.
For these reasons, claims 1-2, 4-6, 8-10, 13, 15-21, 26-28 and 30 stand rejected as recited above in further view of Zhao.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: BR 122016030038 for the teachings of the methods of calculating the accuracy, recited in claim 18.
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.
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/K.A.W./Examiner, Art Unit 3783
/NATHAN R PRICE/Primary Examiner, Art Unit 3783
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