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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 03 April 2025 has been entered.
Response to Amendment
This office action is responsive to the amendment filed 03 December 2025. As directed by the amendment: claims 1-23 are presently pending in this application.
Response to Arguments
The rejection of claims 1-23 is maintained. There is no determining step involved in paragraph [0337] as applicant points out, but rather setting values for the mechanical compliance. Setting values is not determining a mechanical compliance, but rather having parameters for specific thresholds.
Regarding applicant’s arguments over Nelson Konen, the mechanical compliance in the prior art has a spring which has multiple Mechanical Compliance values and is not limited to a single value. The pressure sensitivity to volume change is a variable value that relies on the amount of incremental change. The mechanical compliance of the current applicant is stated (units/psi) vs. reservoir volume, so a change in the units/psi of the spring at different volumes would constitute more than one value related to said spring. Regarding calculating a plurality of occlusion pressure thresholds, the deviation from the actual and expected fluid delivery rates would be a calculated threshold of due to the presence of an occlusion. The unexpected value that is detected is the calculation and the threshold that can be quantified.
Regarding the registering of an occlusion, Nelson Konen detects abnormal flow rates which can indicated occlusions and stores those values in the devices memory. This storage process is the registering of an event that an expected value and an actual value do not match therefore exceeding the predetermined threshold value of expectation.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-23 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. There is no evidence that the device has the capability or steps necessary to “determine” a plurality of MC values. There is a calibration step involved but nothing that is actually determining different, variable values for the mechanical compliance.
Claim Rejections - 35 USC § 102
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(s) 1-23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nelson Konen et al. (henceforth “Nelson Konen”, US 2011/0257591).
Regarding claim 1, Nelson Konen discloses an infusion delivery device (¶[0029]) comprising:
a fluid reservoir (Fig. 2, 34) having a proximal end (where the reservoir is a 3D object that has two ends with one facing away from an ejection area which proximal facing), a distal end (where the reservoir is a 3D object that has two ends with one facing towards an ejection area which is distally facing), and a plunger disposed inside the fluid reservoir and moveable therein (Fig. 2, 32, where the fluid delivery pump and the reservoir act together to deliver fluid and there is piston within the fluid delivery pump);
a fluid path (Fig. 2, 38) in fluid communication with the fluid reservoir (¶[0047]);
at least one pressure sensor interfacing at least one of the fluid reservoir or the fluid path (Fig. 2, 42, where pressure sensor interfaces with the fluid reservoir); and
a processor in communication with the at least one pressure sensor (Fig. 2, 26, where the processor communicates with the sensor 42) and a non-transitory computer-readable medium having encoded thereon instructions that (¶[0111]), when executed by the processor, cause the processor to:
determine a plurality of mechanical compliance (MC) values of the fluid reservoir, wherein each MC value of the plurality of MC values is variable based on a respective volume of liquid in the fluid reservoir (¶[0036], where the device determines pressure changes based on a volume of fluid in the reservoir, this value changes over time as fluid volume changes);
calculate a plurality of occlusion pressure thresholds using, a respective MC value of the plurality of MC values and based on the respective volume of liquid in the fluid reservoir (¶[0090], where unexpected changes in pressure, flow rate, or volume can indicate an occlusion and the thresholds that are calculated using volume and pressure measurements will be a variable value or can also be a static value that can be predetermined);
monitor a signal corresponding to a pressure in the fluid reservoir (¶[0050]);
select an occlusion pressure threshold from the plurality of occlusion pressure thresholds, the selected occlusion pressure threshold corresponding to the volume of liquid in the fluid reservoir (¶[0090], where unexpected volume changes would include an occlusion and the threshold to measure said changes is listed as having a set value range); and
register an occlusion when the pressure exceeds the selected occlusion pressure threshold (¶[0065], where an unexpected change is detected which can be an occlusion passing the threshold and in order to determine this data is taken in and stored for comparison by the memory 86 meaning that the unexpected change is registered).
Regarding claim 2, Nelson Konen discloses the infusion delivery device of claim 1, wherein the plurality of MC values of the fluid reservoir are variable based on the respective volume of the liquid in the fluid reservoir, a medicament delivery rate, or a combination thereof (¶[0036], where the device determines pressure changes based on a volume of fluid in the reservoir, this value changes over time as fluid volume changes).
Regarding claim 3, Nelson Konen discloses the infusion delivery device of claim 1, wherein each of the plurality of occlusion pressure thresholds is pre-programmed in the non-transitory computer-readable medium (¶[0090], where the processor takes information from the memory and needs the memory to direct it with instruction how to read and what to read within the device, therefore, the computer-readable medium contains the variable threshold values).
Regarding claim 4, Nelson Konen discloses the infusion delivery device of claim 1, wherein each of the plurality of occlusion pressure thresholds is static (¶[0090], where there is a value for the thresholds that is known in the device).
Regarding claim 5, Nelson Konen discloses he infusion delivery device of claim 1, wherein each of the plurality of occlusion pressure thresholds is variable (¶[0090], where the threshold value is “approximately” a value and the value has a range meaning the threshold can vary).
Regarding claim 6, Nelson Konen discloses the infusion delivery device of claim 1, wherein the instructions, when executed by the processor, causes the processor to transmit one or more notifications to a user with an alert when the occlusion is registered, wherein the alert comprises a visual alert, an audible alert, or a combination thereof (¶[0099], where an alert can be triggered and has different types of alerts, the alerts occur when there is an unexpected volume event in the device).
Regarding claim 7, Nelson Konen discloses method for an infusion delivery device (¶[0029]) comprising:
determining a plurality of mechanical compliance (MC) values of a fluid reservoir of an infusion delivery device, each MC value corresponding to a respective volume of liquid in the fluid reservoir (¶[0036], where the device determines pressure changes based on a volume of fluid in the reservoir, this value changes over time as fluid volume changes), wherein the infusion delivery device comprises:
a fluid reservoir (Fig. 2, 34) having a proximal end (where the reservoir is a 3D object that has two ends with one facing away from an ejection area which proximal facing), a distal end (where the reservoir is a 3D object that has two ends with one facing towards an ejection area which is distally facing), and a plunger disposed inside the fluid reservoir and moveable therein (Fig. 2, 32, where the fluid delivery pump and the reservoir act together to deliver fluid and there is piston within the fluid delivery pump);
a fluid path (Fig. 2, 38) in fluid communication with the fluid reservoir (¶[0047]);
at least one pressure sensor interfacing at least one of the fluid reservoir or the fluid path (Fig. 2, 42, where pressure sensor interfaces with the fluid reservoir);
calculating a plurality of occlusion pressure thresholds using, a respective MC value of the plurality of MC values based on the respective volume of liquid in the fluid reservoir (¶[0090], where unexpected changes in pressure, flow rate, or volume can indicate an occlusion and the thresholds that are calculated using volume and pressure measurements will be a variable value or can also be a static value that can be predetermined);
monitoring at least one signal corresponding to a pressure in the fluid reservoir (¶[0050]);
selecting an occlusion pressure threshold from the plurality of occlusion pressure thresholds, the selected occlusion pressure threshold corresponding to the volume of liquid in the fluid reservoir(¶[0090], where unexpected volume changes would include an occlusion and the threshold to measure said changes is listed as having a set value range); and
registering an occlusion when the pressure exceeds the selected occlusion pressure threshold (¶[0065], where an unexpected change is detected which can be an occlusion passing the threshold and in order to determine this data is taken in and stored for comparison by the memory 86 meaning that the unexpected change is registered).
Regarding claim 8, Nelson Konen discloses the method of claim 7, wherein the plurality of MC values of the fluid reservoir are variable based on the respective volume of the liquid in the fluid reservoir, a medicament delivery rate, or a combination thereof ((¶[0036], where the device determines pressure changes based on a volume of fluid in the reservoir, this value changes over time as fluid volume changes).
Regarding claim 9, Nelson Konen discloses the method of claim 7, wherein each of the plurality of occlusion pressure thresholds is pre-programmed in the infusion delivery device (¶[0090], where the processor takes information from the memory and needs the memory to direct it with instruction how to read and what to read within the device, therefore, the computer-readable medium contains the variable threshold values).
Regarding claim 10, Nelson Konen discloses the method of claim 7, wherein each of the plurality of occlusion pressure thresholds is static (¶[0090], where there is a value for the thresholds that is known in the device).
Regarding claim 11, Nelson Konen discloses the method of claim 7, wherein each of the plurality of occlusion pressure thresholds is variable (¶[0090], where the threshold value is “approximately” a value and the value has a range meaning the threshold can vary).
Regarding claim 12, Nelson Konen discloses the method of claim 7, further comprising notifying a user with an alert when the occlusion is registered, wherein the alert comprises a visual alert, an audible alert, or a combination thereof (¶[0099], where an alert can be triggered and has different types of alerts, the alerts occur when there is an unexpected volume event in the device).
Regarding claim 13, Nelson Konen discloses an infusion management system (¶[0029]) comprising:
an infusion delivery device (¶[0029]) comprising:
a fluid reservoir (Fig. 2, 34) having a proximal end (where the reservoir is a 3D object that has two ends with one facing away from an ejection area which proximal facing), a distal end (where the reservoir is a 3D object that has two ends with one facing towards an ejection area which is distally facing), and a plunger disposed inside the fluid reservoir and moveable therein (Fig. 2, 32, where the fluid delivery pump and the reservoir act together to deliver fluid and there is piston within the fluid delivery pump);
a fluid path (Fig. 2, 38) in fluid communication with the fluid reservoir (¶[0047]);
at least one pressure sensor interfacing at least one of the fluid reservoir or the fluid path (Fig. 2, 42, where pressure sensor interfaces with the fluid reservoir); and
a processor in communication with the at least one pressure sensor (Fig. 2, 26, where the processor communicates with the sensor 42) and a non-transitory computer-readable medium having encoded thereon instructions that (¶[0111]), when executed by the processor, cause the processor to:
determine a plurality of mechanical compliance (MC) values of the fluid reservoir, wherein each MC value of the plurality of MC values is variable based on a respective volume of liquid in the fluid reservoir (¶[0036], where the device determines pressure changes based on a volume of fluid in the reservoir, this value changes over time as fluid volume changes);
calculate a plurality of occlusion pressure thresholds using, a respective MC value of the plurality of MC values and based on the respective volume of liquid in the fluid reservoir (¶[0090], where unexpected changes in pressure, flow rate, or volume can indicate an occlusion and the thresholds that are calculated using volume and pressure measurements will be a variable value or can also be a static value that can be predetermined);
monitor a signal corresponding to a pressure in the fluid reservoir (¶[0050]);
select an occlusion pressure threshold from the plurality of occlusion pressure thresholds, the selected occlusion pressure threshold corresponding to the volume of liquid in the fluid reservoir (¶[0090], where unexpected volume changes would include an occlusion and the threshold to measure said changes is listed as having a set value range);
register an occlusion when the pressure exceeds the selected occlusion pressure threshold (¶[0065], where an unexpected change is detected which can be an occlusion passing the threshold and in order to determine this data is taken in and stored for comparison by the memory 86 meaning that the unexpected change is registered); and
at least one controller in communication with the infusion delivery device, wherein the at least one controller is configured to exchange data or instructions with the infusion delivery device (¶[0036]).
Regarding claim 14, Nelson Konen discloses the infusion management system of claim 13, wherein the at least one controller comprises a user interface for communicating with a user (¶[0058]).
Regarding claim 15, Nelson Konen discloses the infusion management system of claim 13, wherein the at least one controller comprises a smart phone (¶[0067], where the data transfer and controlling method is cone from a remote device that can include a smart phone).
Regarding claim 16, Nelson Konen discloses the infusion management system of claim 13, wherein the processor is configured transmit one or more notifications to the at least one controller (¶[0067] & [0071]).
Regarding claim 17, Nelson Konen discloses the infusion management system of claim 13, wherein the at least one controller comprises a dedicated wireless controller (¶[0067]).
Regarding claim 18, Nelson Konen discloses the infusion management system of claim 13, wherein the plurality of MC values of the fluid reservoir are variable based on the respective volume of the liquid in the fluid reservoir, a medicament delivery rate, or a combination thereof (¶[0036], where the device determines pressure changes based on a volume of fluid in the reservoir, this value changes over time as fluid volume changes).
Regarding claim 19, Nelson Discloses the infusion management system of claim 13, wherein each of the plurality of occlusion pressure thresholds is pre-programmed in the non-transitory computer-readable medium (¶[0090], where the processor takes information from the memory and needs the memory to direct it with instruction how to read and what to read within the device, therefore, the computer-readable medium contains the variable threshold values).
Regarding claim 20, Nelson Konen discloses the infusion management system of claim 13, wherein each of the plurality of occlusion pressure thresholds is static(¶[0090], where there is a value for the thresholds that is known in the device).
Regarding claim 21, Nelson Konen discloses the infusion delivery device of claim 1, wherein each of the plurality of occlusion pressure thresholds are set such that an occluded volume varies for different occlusion pressure thresholds of the plurality of occlusion pressure threshold (¶[0036], where the device determines pressure changes based on a volume of fluid in the reservoir, this value changes over time as fluid volume changes, furthermore, the device has variable occlusion thresholds and the unexpected volume changes that factor into these thresholds are variable based on volume, ¶[0090]).
Regarding claim 22, Nelson Konen discloses the infusion delivery device of claim 1, wherein each of the plurality of occlusion pressure thresholds are set such that an occluded volume required to trigger an alarm varies with the volume of liquid in the fluid reservoir.
Regarding claim 23, Nelson Konen discloses an infusion delivery device (¶[0029]) comprising:
a fluid reservoir (Fig. 2, 34) having a proximal end (where the reservoir is a 3D object that has two ends with one facing away from an ejection area which proximal facing), a distal end (where the reservoir is a 3D object that has two ends with one facing towards an ejection area which is distally facing), and a plunger disposed inside the fluid reservoir and moveable therein (Fig. 2, 32, where the fluid delivery pump and the reservoir act together to deliver fluid and there is piston within the fluid delivery pump);
a fluid path (Fig. 2, 38) in fluid communication with the fluid reservoir (¶[0047]);
at least one pressure sensor interfacing at least one of the fluid reservoir or the fluid path (Fig. 2, 42, where pressure sensor interfaces with the fluid reservoir); and
a processor in communication with the at least one pressure sensor (Fig. 2, 26, where the processor communicates with the sensor 42) and a non-transitory computer-readable medium having encoded thereon instructions that (¶[0111]), when executed by the processor, cause the processor to:
determine a plurality of mechanical compliance (MC) values of the fluid reservoir, the MC values being variable based on a respective volume of liquid in the fluid reservoir (¶[0036], where the device determines pressure changes based on a volume of fluid in the reservoir, this value changes over time as fluid volume changes); and
select an occlusion pressure threshold required to trigger an alarm from a plurality of occlusion pressure thresholds, wherein each of the plurality of occlusion pressure thresholds is calculated using a respective MC value of the plurality of MC values based on the respective volume of liquid in the fluid reservoir (¶[0090], where unexpected changes in pressure, flow rate, or volume can indicate an occlusion and the thresholds that are calculated using volume and pressure measurements will be a variable value or can also be a static value that can be predetermined, where the value is arbitrary for an alarm to be triggered, ¶[0099], where an alert can be triggered and has different types of alerts, the alerts occur when there is an unexpected volume event in the device, which can occur at a set value).
wherein the occlusion pressure threshold is selected such that an occluded volume required to trigger the alarm changes based on the respective volume of liquid in the fluid reservoir, thereby adjusting a sensitivity of occlusion detection so as to minimize a false alarm, while staying within safety limits of the infusion delivery device (¶[0090], where the threshold value is “approximately” a value and the value has a range meaning the threshold can vary, the value can trigger an alarm and because there is a + or - range the sensitivity of the device can be adjusted along with alarm values).
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 HADEN M RITCHIE whose telephone number is (703)756-1699. The examiner can normally be reached M-F 8am-5:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bhisma Mehta can be reached at 571-272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HADEN MATTHEW RITCHIE/Examiner, Art Unit 3783
/BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783
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