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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 04/08/2026 has been entered.
Response to Arguments
Applicant’s arguments with respect to claim 21 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record or any teaching or matter specifically challenged in the argument.
In light of an updated search, the allowance of claims 1-20 and 22 is withdrawn. See new rejection below of the respective claims.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 22 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 22, the claim recites “a kink detection system having a sensor” and then later recites “a sensor configured to measure an extent of deformation of the diaphragm”, however it is unclear if the first introduced is the same sensor being recited later in the claim or two distinct sensors. Therefore, the claim has been rendered indefinite.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-3, 6-17 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Flaherty US7887505 in view of Olsen US5935106.
Regarding claim 1, Flaherty discloses a disease management device (fluid delivery device-10) comprising: a medical delivery pump (dispensers-40 can be a pump device, Col 8 line 4-27) configured to deliver a medication (Col 5 line 46-61) from a medication pouch (reservoir-30) to a patient via a cannula implanted in a patient (exit port assembly-70 connected to flow path -210 includes a cannula, Col 7 line 32-60); and a kink detection system (flow condition assembly-200) configured to measure an obstruction in the cannula (Col 5 line 37-45, Col 7 line 6-20), the kink detection system comprising: a fluid receiving portion configured to receive fluid from the medical delivery pump (Col 8 lines 28-Col 9 line 32 and Figs 3-4 which shows the detector positioned on the flow path-210); a diaphragm (diaphragm-220) coupled to the fluid receiving portion, the diaphragm configured to deform in correspondence with a change in pressure in the fluid received (Col 8 line 28-Col 9 line 32); a sensor (Sensor-230) configured to measure an extent of deformation of the diaphragm (Col 8 line 44-Col 9 line 16); one or more hardware processors (processors-50) and output an alert to the patient if the change passes the threshold (Col 9 line 23-32 and Col 9 line 63-Col 10 line 19); and a fluid outlet (exit port-70) configured to deliver the fluid to the patient.
However, Flaherty fails to disclose one or more hardware processors configured to: determine a pressure in the fluid based on the extent of deformation ; determine if a change in the pressure in the fluid passes a threshold change; output an alert to the patient if the change in pressure passes the threshold. Olsen discloses one or more hardware processors (Control module-46 includes processor module-50) configured to: determine a pressure in the fluid based on the extent of deformation (Col 5 line 51-Col 6 line 9) ; determine if a change in the pressure in the fluid passes a threshold change (Col 7 line 43-Col 8 line 31); output an alert to the patient if the change in pressure passes the threshold (Col 8 line 13-16, Col 10 line 33-Col 12 line 63 discloses outputting an alert based on a pressure passing a threshold).
It would have been obvious to one of ordinary skill in the art before the effective filing date to include Olsen into Flaherty for the purpose of increasing the life of the device. The modification would allow for shutting down or adjusting the device if undesired pressure is detected which protects the device from potential repair or replacement.
Regarding claim 2, Flaherty discloses the disease management device according to claim 1.
However, Flaherty fails to disclose the sensor comprises a capacitive sensor. Olsen discloses the sensor comprises a capacitive sensor. (Col 5 line 51-Col 6 line 9)
It would have been obvious to one of ordinary skill in the art before the effective filing date to include Olsen into Flaherty for the purpose of increasing detection accuracy. The modification would allow for using sensors with a higher detection sensitivity which would increase measurement accuracy.
Regarding claim 3, Flaherty in view of Olsen discloses the device according to claim 1.
Furthermore, Flaherty discloses the sensor comprises a conductive sensor. (Col 8 line 65-Col 9 line 16)
Regarding claim 6, Flaherty in view of Olsen discloses the device according to claim 3.
Furthermore, Flaherty discloses the conductive sensor is located within a conductive sensing circuit (open circuit-230), the conductive sensing circuit comprising: a bias resistor (leads-232, 234); a conductive strip (conductive coating-236 on surface-224); and a controller (controller-50). (Col 9 17-32)
Regarding claim 7, Flaherty in view of Olsen discloses the device according to claim 6.
Furthermore, Flaherty discloses the conductive strip (coating-236 on surface-224) is configured to stretch as the pressure in the fluid is increased. (Col 9 line 6-16)
Regarding claim 8, Flaherty in view of Olsen discloses the device according to claim 1.
Furthermore, Flaherty discloses the one or more hardware processors (processor-50) are further configured to communicate with peripheral devices via Bluetooth (wireless receiver-60 communicates with remote device-100 using antenna-130). (Col 5 line 62-Col 6 line 9, Col 6 line 51-62)
Regarding claim 9, Flaherty discloses a detection system (fluid delivery device-10 connected to device-100) configured to detect an obstruction within a fluid flow path (flow path-210 connected to exit port-70), the detection system comprising: a fluid receiving portion configured to receive fluid from a delivery pump (dispensers-40 can be a pump device, Col 8 line 4-27), (Col 8 lines 28-Col 9 line 32 and Figs 3-4 which shows the detector positioned on the flow path-210); a diaphragm (diaphragm-220) coupled to the fluid receiving portion, the diaphragm configured to deform in correspondence with a change in pressure in the fluid received (Col 8 line 28-Col 9 line 32); a sensor (sensor-230) configured to measure an extent of deformation of the diaphragm (Col 8 line 44-Col 9 line 16); and one or more hardware processors (processors-50) configured to output an alert to a user if the change in pressure passes the predetermined threshold (Col 9 line 23-32 and Col 9 line 63-Col 10 line 19).
However, Flaherty fails to disclose determine a pressure in the fluid based on the extent of deformation; determine if a change in the pressure in the fluid passes a predetermined pressure threshold. Olsen discloses determine a pressure in the fluid based on the extent of deformation (Col 5 line 51-Col 6 line 9); determine if a change in the pressure in the fluid passes a predetermined pressure threshold (Col 7 line 43-Col 8 line 31). (Col 8 line 13-16, Col 10 line 33-Col 12 line 63 discloses outputting an alert based on a pressure passing a threshold).
It would have been obvious to one of ordinary skill in the art before the effective filing date to include Olsen into Flaherty for the purpose of increasing the life of the device. The modification would allow for shutting down or adjusting the device if undesired pressure is detected which protects the device from potential repair or replacement.
Regarding claim 10, Flaherty discloses the detection system according to claim 9.
However, Flaherty fails to disclose the sensor comprises a capacitive sensor. Olsen discloses the sensor comprises a capacitive sensor. (Col 5 line 51-Col 6 line 9)
It would have been obvious to one of ordinary skill in the art before the effective filing date to include Olsen into Flaherty for the purpose of increasing detection accuracy. The modification would allow for using sensors with a higher detection sensitivity which would increase measurement accuracy.
Regarding claim 11, Flaherty in view of Olsen discloses the detection system according to claim 9.
Furthermore, Flaherty discloses the sensor comprises a conductive sensor. (Col 8 line 65-Col 9 line 16)
Regarding claim 12, Flaherty discloses a method (Abstract, claim 3, device-10 implements the method) of detecting a kink (flow condition sensor assembly-200 detects an occlusion/kink) within a disease management device (Col 5 line 46-61), the method comprising: passing fluid from a fluid source (reservoir-30) to a pump (dispenser-40 can be a pumping device, Col 8 line 4-27) through a fluid flow path within the disease management device; passing fluid from the pump to a kink detector (flow condition sensor assembly-200) through the fluid flow path (flow path-210); sensing movement of a diaphragm connected to the kink detector in response to the fluid passing (sensor-230); and passing fluid from the kink detector to a cannula (exit port-70 includes a cannula) located at an implantation site of a patient. (Fig 1, Col 7 line 32-60)
However, Flaherty fails to disclose measuring pressure of the fluid based on movement of the diaphragm; determining if a kink is present within the fluid flow path based on the pressure of the fluid exceeding a predetermined pressure threshold. Olsen discloses measuring pressure of the fluid based on movement of the diaphragm (Col 5 line 51-Col 6 line 9); determining if a kink is present within the fluid flow path based on the pressure of the fluid exceeding a predetermined pressure threshold (Col 8 line 13-16, Col 10 line 33-Col 12 line 63).
It would have been obvious to one of ordinary skill in the art before the effective filing date to include Olsen into Flaherty for the purpose of increasing the life of the device. The modification would allow for shutting down or adjusting the device if undesired pressure is detected which protects the device from potential repair or replacement.
Regarding claim 13, Flaherty in view of Olsen discloses the method according to claim 12.
Furthermore, Flaherty discloses alerting a patient of the kink based on a determination of a kink presence. (Col 9 line 23-32 and Col 8 line 63-Col 10 line 19)
Regarding claim 14, Flaherty discloses the method according to claim 12.
However, Flaherty fails to disclose a capacitive sensor senses movement of the diaphragm. Olsen discloses a capacitive sensor senses movement of the diaphragm. (Col 5 line 51-Col 6 line 9)
It would have been obvious to one of ordinary skill in the art before the effective filing date to include Olsen into Flaherty for the purpose of increasing detection accuracy. The modification would allow for using sensors with a higher detection sensitivity which would increase measurement accuracy.
Regarding claim 15, Flaherty in view of Olsen discloses the method according to claim 12.
Furthermore, Flaherty discloses a conductive sensor senses movement of the diaphragm. (Col 8 line 65-Col 9 line 16)
Regarding claim 16, Flaherty in view of Olsen discloses the method according to claim 15.
Furthermore, Flaherty discloses the conductive sensor is located within a conductive sensing circuit (open circuit-230) comprising: a conductive strip (conductive coating-238 on surface-224) configured to measure a force of the diaphragm; a bias resistor (leads-232, 234); and a controller (Controller-50). (Col 9 line 17-32)
Regarding claim 17, Flaherty in view of Olsen discloses the method according to claim 16.
Furthermore, Flaherty discloses the conductive strip (coating-236 on surface-224) is configured to stretch as the pressure in the fluid is increased. (Col 9 line 6-16) Regarding claim 22, Flaherty discloses a disease management device (fluid delivery device-10) comprising:
a medical delivery pump (dispensers-40 can be a pump device, Col 8 line 4-27) configured to deliver a flow of medication (reservoir-30) to a patient (Exit port-70, Col 5 line 46-61); and
a kink detection system (flow condition assembly-200) having a sensor (sensors-230), the kink detection system configured to indicate an increase in pressure in the flow or a lack of the flow when the flow is expected (Col 5 line 37-45, Col 7 line 11-20), the kink detection system further comprising:
a fluid receiving portion () configured to receive fluid from the medical delivery pump (Col 8 lines 28-Col 9 line 32 and Figs 3-4 which shows the detector positioned on the flow path-210);
a diaphragm (diaphragm-220) coupled to the fluid receiving portion, the diaphragm configured to deform corresponding to a change in pressure in the fluid received (Col 8 line 28-Col 9 line 32);
a sensor (sensors-230) configured to measure an extent of deformation of the diaphragm;
one or more hardware processors (processors-50) configured to:
determine a pressure in the fluid based on the extent of deformation (Col 8 line 44-Col 9 line 16); and
output an alert to the patient if the change passes the threshold change (Col 9 line 23-32 and Col 9 line 63-Col 10 line 19); and a fluid outlet (exit port-70) configured to deliver the fluid to the patient.
However, Flaherty discloses determine if a change in the pressure in the fluid passes a threshold change; and output an alert to the patient if the change in pressure passes the threshold change. Olsen discloses determine if a change in the pressure in the fluid passes a threshold change (Col 7 line 43-Col 8 line 31); and output an alert to the patient if the change in pressure passes the threshold change. (Col 8 line 13-16, Col 10 line 33-Col 12 line 63 discloses outputting an alert based on a pressure passing a threshold).
It would have been obvious to one of ordinary skill in the art before the effective filing date to include Olsen into Flaherty for the purpose of increasing the life of the device. The modification would allow for shutting down or adjusting the device if undesired pressure is detected which protects the device from potential repair or replacement.
Claims 4-5 and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Flaherty US7887505 in view of Olsen US5935106 in further view of Haase 6700392.
Regarding claim 4, the combination of Flaherty in view of Olsen disclose the device according to claim 2.
However, the combination fails to disclose the capacitive sensor is located within a capacitive sensing circuit, the capacitive sensing circuit comprising: a bias resistor; a touchpad; a capacitor; and a controller. Haase discloses the capacitive sensor (sensing capacitor-310) is located within a capacitive sensing circuit (circuit-100), the capacitive sensing circuit comprising: a bias resistor (resistor-312); a touchpad (capacitor-310); a capacitor (Schmitt trigger-110, 309); and a controller (counter/timer module, Col 9 line 27-37). (Fig 1 and 3)
It would have been obvious to one of ordinary skill in the art before the effective filing date to include Haase into Flaherty for the purpose of increasing detection accuracy. The modification would allow for using sensors with a higher detection sensitivity which would increase measurement accuracy.
Regarding claim 5, the combination of Flaherty in view of Olsen disclose the device according to claim 4.
However, the combination fails to disclose an electrical capacitance of the touchpad (capacitor-310) is configured to correspond to movement of the diaphragm. (Col 6 line 5-Col 7 line 10)
It would have been obvious to one of ordinary skill in the art before the effective filing date to include Haase into Flaherty for the purpose of increasing detection accuracy. The modification would allow for using sensors with a higher detection sensitivity which would increase measurement accuracy.
Regarding claim 18, the combination of Flaherty in view of Olsen disclose the method according to claim 14.
However, the combination fails to disclose the capacitive sensor is located within a capacitive sensing circuit comprising: a bias resistor; a touchpad; a capacitor; and a controller. Haase discloses the capacitive sensor (sensing capacitor-310) is located within a capacitive sensing circuit (circuit-100) comprising: a bias resistor (resistor-312); a touchpad (capacitor-310); a capacitor (Schmitt trigger-110, 309); and a controller (counter/timer module, Col 9 line 27-37). (Fig 1 and 3)
It would have been obvious to one of ordinary skill in the art before the effective filing date to include Haase into Flaherty for the purpose of increasing detection accuracy. The modification would allow for using sensors with a higher detection sensitivity which would increase measurement accuracy.
Regarding claim 19, the combination of Flaherty in view of Olsen disclose the method according to claim 18.
However, the combination fails to disclose the capacitor measures an electrical capacitance of the touchpad. Haase discloses the capacitor (Schmitt treigger-110, 309) measures an electrical capacitance of the touchpad (capacitor-310).
It would have been obvious to one of ordinary skill in the art before the effective filing date to include Haase into Flaherty for the purpose of increasing detection accuracy. The modification would allow for using sensors with a higher detection sensitivity which would increase measurement accuracy.
Regarding claim 20, the combination of Flaherty in view of Olsen disclose the method according to claim 19.
However, the combination fails to disclose the electrical capacitance is configured to correspond to the movement of the diaphragm. Haase discloses the electrical capacitance is configured to correspond to the movement of the diaphragm. (Col 6 line 5-Col 7 line 10)
It would have been obvious to one of ordinary skill in the art before the effective filing date to include Haase into Flaherty for the purpose of increasing detection accuracy. The modification would allow for using sensors with a higher detection sensitivity which would increase measurement accuracy.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim 21 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Flaherty US7887505.
Regarding claim 21, Flaherty discloses a method (Abstract, claim 3, device-10 implements the method) of detecting a kink (flow condition sensor assembly-200 detects an occlusion/kink) within a medication delivery system (Col 5 line 46-61), the method comprising:
passing fluid from a fluid source (reservoir-30) to a pump (dispenser-40 can be a pumping device, Col 8 line 4-27) through a fluid flow path (flow path-210) within the medication delivery system;
passing fluid from the pump to a kink detector (assembly-200) through the fluid flow path; and
sensing (sensor-230), based on deformation of a diaphragm (diaphragm-220) coupled to the fluid flow path, an increase in pressure in the fluid or a lack of a flow of fluid when the flow is expected (Col 5 line 37-45, Col 7 line 11-20).
Conclusion
The prior art as cited on the PTO-892 is made of record and not relied upon but considered pertinent to applicant's disclosure.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NIGEL H PLUMB whose telephone number is (571)272-8886. The examiner can normally be reached Monday-Friday 7am-5pm.
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/NIGEL H PLUMB/Examiner, Art Unit 2855
/Eric S. McCall/Primary Examiner, Art Unit 2855
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