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 Arguments
In view of the appeal brief filed on 10/14/2024, PROSECUTION IS HEREBY REOPENED. New grounds of rejection are set forth below.
To avoid abandonment of the application, appellant must exercise one of the following two options:
(1) file a reply under 37 CFR 1.111 (if this Office action is non-final) or a reply under 37 CFR 1.113 (if this Office action is final); or,
(2) initiate a new appeal by filing a notice of appeal under 37 CFR 41.31 followed by an appeal brief under 37 CFR 41.37. The previously paid notice of appeal fee and appeal brief fee can be applied to the new appeal. If, however, the appeal fees set forth in 37 CFR 41.20 have been increased since they were previously paid, then appellant must pay the difference between the increased fees and the amount previously paid.
A Supervisory Patent Examiner (SPE) has approved of reopening prosecution by signing below:
/KEVIN C SIRMONS/ Supervisory Patent Examiner, Art Unit 3783
Status of the Claims
Claims 1-20 are pending in the application.
Applicant’s arguments, see the appeal brief filed 10/14/2024, with respect to the rejections of claims 1-20 under 35 U.S.C. 112(a) and 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejections have been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of 35 U.S.C. 112(b).
Specification
The disclosure is objected to because of the following informalities:
The Specification is missing a Cross-Reference to Related Applications section which mentions the serial numbers and filing dates of the applications to which the instant application claims priority.
Appropriate correction is required.
Claim Objections
Claims 1, 6-14, and 16-20 are objected to because of the following informalities:
-Claim 1, line 4: please correct “fluid” to “the fluid”
-Claim 1, line 6: please correct “a volume” to “the volume”
-Claim 1, line 6: please correct “fluid” to “the fluid”
-Claim 1, line 8: please correct “generate pump measurement” to “generate a pump measurement”
-Claim 6, line 5: please correct “time duration” to “the time duration”
-Claim 7, line 4: please correct “an average value” to “the average value”
-Claim 8, line 3: please correct “a duration” to “the time duration”
-Claim 8, line 9: please correct “the stroke duration difference” to “the dispense stroke duration difference”
-Claim 8, line 10: please delete “comprising”
-Claim 9, line 5: please correct “the stroke duration difference” to “the dispense stroke duration difference”
-Claim 10, line 2: please correct “time duration” to “the time duration”
-Claim 10, line 3: please correct “corresponding to the” to “corresponding to”
-Claim 10, line 6: please correct “to and analyze” to “to analyze”
-Claim 11, line 4: please correct “which fluid” to “which the fluid”
-Claim 11, line 6: please correct “a volume” to “the volume”
-Claim 11, line 6: please correct “fluid” to “the fluid”
-Claim 11, line 16: please correct “a pump measurement” to “the pump measurement”
-Claim 12, line 2: please correct “an occlusion alert” to “as an occlusion alert”
-Claim 12, line 2: please correct “a plurality” to “the plurality”
-Claim 13, line 3: please correct “a plurality” to “the plurality”
-Claim 14, line 2: please correct “a pump measurement” to “the pump measurement”
-Claim 14, line 3: please correct “a time duration” to “the time duration”
-Claim 16, line 6: please correct “time duration” to “the time duration”
-Claim 17, lines 3-4: please correct “an average value” to “the average value”
-Claim 18, line 2: please correct “a duration” to “the time duration”
-Claim 18, lines 8-9: please correct “the stroke duration difference” to “the dispense stroke duration difference”
-Claim 18, lines 10-11: please correct “a plurality” to “the plurality”
-Claim 19, line 5: please correct “the stroke duration difference” to “the dispense stroke duration difference”
-Claim 20, line 2: please correct “time duration” to “the time duration”
-Claim 20, line 3: please correct “the stroke duration” to “stroke duration”
-Claim 20, line 6: please correct “a plurality” to “the plurality”
Appropriate correction is required.
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.
Claims 5, 8, 10, 15, 18, and 20 are 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.
Claim 5 recites the limitation “the predetermined metric is a selected time duration that is shorter than an average value of the pump measurement when no occlusion is occurring in the pump”. However, this appears to contradict the limitation “the predetermined metric is a selected time duration that is longer than an average value of the pump measurement when no occlusion is occurring in the pump” previously recited in claim 1. For examination purposes, the Examiner interprets that the limitation recited in claim 5 is an additional metric that can be used to determine an occlusion (i.e. claim 1 requires that a longer than average time duration determines an occlusion and claim 5 requires that an occlusion can also be determined by a shorter than average time duration such that multiple scenarios can determine an occlusion). The language of claim 5 should be reworded such that the limitations are no longer contradictory.
Claim 8 recites the limitation “the predetermined metric corresponding to stroke duration is a selected time duration that is shorter than an average value of the stroke duration when no occlusion is occurring in the pump”. However, this appears to contradict the limitation “the predetermined metric is a selected time duration that is longer than an average value of the pump measurement when no occlusion is occurring in the pump” previously recited in claim 1. For examination purposes, the Examiner interprets that the limitation recited in claim 8 is an additional metric that can be used to determine an occlusion (i.e. claim 1 requires that a longer than average time duration determines an occlusion and claim 8 requires that an occlusion can also be determined by a shorter than average time duration such that multiple scenarios can determine an occlusion). The language of claim 8 should be reworded such that the limitations are no longer contradictory.
Claim 10 recites the limitation “the predetermined metric corresponding to stroke duration is a selected time duration that is shorter than an average value of the stroke duration when no occlusion is occurring in the pump”. However, this appears to contradict the limitation “the predetermined metric is a selected time duration that is longer than an average value of the pump measurement when no occlusion is occurring in the pump” previously recited in claim 1. For examination purposes, the Examiner interprets that the limitation recited in claim 10 is an additional metric that can be used to determine an occlusion (i.e. claim 1 requires that a longer than average time duration determines an occlusion and claim 8 requires that an occlusion can also be determined by a shorter than average time duration such that multiple scenarios can determine an occlusion). The language of claim 10 should be reworded such that the limitations are no longer contradictory.
Claim 15 recites the limitation “using the predetermined metric as a selected time duration that is shorter than an average value of the pump measurement when no occlusion is occurring in the pump”. However, this appears to contradict the limitation “the predetermined metric is a selected time duration that is longer than an average value of the pump measurement when no occlusion is occurring in the pump” previously recited in claim 11. For examination purposes, the Examiner interprets that the limitation recited in claim 15 is an additional metric that can be used to determine an occlusion (i.e. claim 11 requires that a longer than average time duration determines an occlusion and claim 15 requires that an occlusion can also be determined by a shorter than average time duration such that multiple scenarios can determine an occlusion). The language of claim 15 should be reworded such that the limitations are no longer contradictory.
Claim 18 recites the limitation “the predetermined metric corresponding to stroke duration is a selected time duration that is shorter than an average value of the stroke duration when no occlusion is occurring in the pump”. However, this appears to contradict the limitation “the predetermined metric is a selected time duration that is longer than an average value of the pump measurement when no occlusion is occurring in the pump” previously recited in claim 11. For examination purposes, the Examiner interprets that the limitation recited in claim 18 is an additional metric that can be used to determine an occlusion (i.e. claim 11 requires that a longer than average time duration determines an occlusion and claim 18 requires that an occlusion can also be determined by a shorter than average time duration such that multiple scenarios can determine an occlusion). The language of claim 18 should be reworded such that the limitations are no longer contradictory.
Claim 20 recites the limitation “the predetermined metric corresponding to stroke duration is a selected time duration that is shorter than an average value of the stroke duration when no occlusion is occurring in the pump”. However, this appears to contradict the limitation “the predetermined metric is a selected time duration that is longer than an average value of the pump measurement when no occlusion is occurring in the pump” previously recited in claim 11. For examination purposes, the Examiner interprets that the limitation recited in claim 20 is an additional metric that can be used to determine an occlusion (i.e. claim 11 requires that a longer than average time duration determines an occlusion and claim 20 requires that an occlusion can also be determined by a shorter than average time duration such that multiple scenarios can determine an occlusion). The language of claim 20 should be reworded such that the limitations are no longer contradictory.
Allowable Subject Matter
Claims 1-4, 6-7, 9, 11-14, 16-17, and 19 are allowable.
Claims 5, 8, 10, 15, 18, and 20 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
In regards to independent claim 1 (and independent claim 11 which is a method of using substantially the same device as claim 1), the prior art of record fails to disclose or render obvious before the effective filing date of the claimed invention the infusion device (and method) as claimed, specifically including the processing device configured to analyze pump measurements comprising the pump measurement for each of a plurality of the at least one of the aspirate stroke and the dispense stroke and determine when the pump measurements comprise a plurality of the pump measurement that satisfy a predetermined metric, the predetermined metric designating an indication of occlusion; wherein the pump measurement corresponds to a time duration of the at least one of the aspirate stroke and the dispense stroke, and the predetermined metric is a selected time duration that is longer than an average value of the pump measurement when no occlusion is occurring in the pump.
The closest prior art of record is Slate et al. (US 4,950,235 A) and Seitz et al. (US 11,458,246 B2).
Slate discloses an infusion device (see Fig. 3) with integral occlusion sensing comprising: a pump comprising a chamber (pump cylinder 112) configured with at least one port (inlet and outlet valves) to receive fluid into the chamber (pump cylinder 112) from a reservoir (fluid source, not shown) and through which fluid flows out of the chamber (pump cylinder 112) (see col. 40, lines 40-60), and a pumping mechanism (motor 606, see Fig. 81) configured to control aspiration of a volume of the fluid into the chamber (pump cylinder 112) during an aspirate stroke (via opening inlet valve actuator 620A) and to control dispensing of a volume of fluid from the chamber (pump cylinder 112) during a dispense stroke (via opening outlet valve actuator 620B) (see col. 40 lines 40-67); a pump measurement device (sensor 892, Fig. 119) configured to generate pump measurement related to at least one of each aspirate stroke performed by the pump (see col. 47 lines 12-25); and a processing device (comparator 836 and calibrating circuitry 834) configured to determine when the pump measurement satisfies a predetermined metric designating an occlusion (see col. 48 lines 12-22).
Seitz teaches an infusion device (see Figs. 1A-2C) with integral occlusion sensing comprising: a processing device configured to determine when the pump measurements satisfy a predetermined metric, the predetermined metric designating an indication of occlusion; wherein the pump measurement corresponds to a time duration, and the predetermined metric is a selected time duration that is longer than an average value of the pump measurement when no occlusion is occurring in the pump (see col. 3 lines 41-53, col. 7 line 16 – col. 8 line 3, col. 8 lines 33-42).
However, neither Slate nor Seitz teach the processing device configured to analyze pump measurements comprising the pump measurement for each of a plurality of the at least one of the aspirate stroke and the dispense stroke and determine when the pump measurements comprise a plurality of the pump measurement that satisfy a predetermined metric, the predetermined metric designating an indication of occlusion; wherein the pump measurement corresponds to a time duration of the at least one of the aspirate stroke and the dispense stroke, and the predetermined metric is a selected time duration that is longer than an average value of the pump measurement when no occlusion is occurring in the pump.
Claims 2-4, 6-7, 9, 12-14, 16-17, and 19 are allowable by virtue of their dependency on allowable claims 1 and 11.
Claims 5, 8, 10, 15, 18, and 20 would be allowable by virtue of their dependency on allowable claims 1 and 11 if also rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AVERY SMALE whose telephone number is (571)270-7172. The examiner can normally be reached Mon.-Fri. 8-4 ET.
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, Kevin Sirmons can be reached at (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AVERY SMALE/Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
Prosecution Insights