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 .
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.
Claim(s) 1-6 and 10-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Olsen (US Pat. No. 5,695,473) in view of Emami et al. (US PgPub 2016/0038727 A1).
Claim 1. Olsen discloses an infusion system, comprising:
an administration set (26) configured to provide a fluidic pathway between a supply of infusate (24) and an infusion set (54) (Fig. 1; col. 4, line 60 until col. 5, line 9);
an infusion pump (20, Fig. 1) including:
at least one pressure sensor (42, 44) configured to sense a pressure of infusate within the administration set (Fig. 1; col. 5, lines 40-47); and
a control unit (46) configured to monitor the sensed pressure (col. 5, lines 65-67), and apply a continual calculated tare adjustment to the sensed pressure during operation of the infusion pump to deliver infusate through the administration set, the tare adjustment to compensate for a decay of observable stress within the administration set as a result of stress relaxation (via normalization process via calculation to normalize force or pressure readings by accounting for the tube force, based on standard relaxation curve using a linear function of logarithmic time, see col. 3, lines 20-39; and the estimated tube force is subtracted from tube wall force measurement to determine actual fluid pressure, see col. 9, line 46 until col. 10, line 29 and see also Figs. 8A, 8B and the description for the additional specifics, col. 11 lines 25-27, col. 12 lines 1-9 measurements are taken throughout the process and are used for normalization calculations to update the pump control during operation). Olsen discloses that tube force factoring includes working parameters for the system (col. 10 lines 30-32) but do not specially disclose a non-linear adjustment. However, Emami et al. teach functions may be used to compensate for non-linear behavior in a delivery system which may relate to differences in line resistance or drifts in performance overtime ([0061]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use a non-linear adjustment as Olsen discloses factoring in working parameters and Emami et al. teach such parameters may be non-linear based on the properties of the system.
Claim 2. Olsen discloses the infusion system of claim 1, further comprising a pump drive mechanism (32) configured to urge the infusate through the administration set by temporarily compressing a segment of the administration set (col. 5, lines 28-39 and Fig. 4A-4E further described in col. 6, line 28 until col. 8, line 28).
Claim 3. Olsen discloses the infusion system of claim 2, wherein the pump drive mechanism comprises a peristaltic drive mechanism (col. 4, lines 57-59 and Fig. 4A-4E; col. 6, line 28 until col. 8, line 28).
Claim 4. Olsen discloses the infusion system of claim 2, wherein the at least one pressure sensor comprises an upstream pressure sensor (44) positioned upstream of the pump drive mechanism, a downstream pressure sensor (42) positioned downstream of the pump drive mechanism, or a combination thereof (Fig. 1; col. 5, lines 40-47).
Claim 5. Olsen discloses the infusion system of claim 1, wherein the control unit is configured to monitor the sensed pressure, in part, to detect the presence of an occlusion (col. 4, line 33-50; col. 10, lines 18-29).
Claim 6. Olsen discloses the infusion system of claim 1, wherein the tare adjustment is calculated by the control unit based at least in part on data gathered by the at least one pressure sensor (col. 10, lines 17-29; see also Figs. 8A, 8B and the description for the specifics steps).
Claim 10. Olsen discloses the infusion system of claim 1, wherein the tare adjustment is compared to acceptance criteria prior to application by the control unit (col. 7, line 66 until col. 8, line 13).
Claim 11. Olsen discloses an infusion system, comprising:
an infusion pump (20) comprising a drive mechanism (32), at least one pressure sensor (42, 44) and a control unit (46) (Fig. 1); and
an administration set (26) configured to provide a fluidic pathway between a supply of infusate (24) and an infusion set (54) (Fig. 1);
wherein the infusion pump is configured to monitor a pressure within the administration set as sensed by the at least one pressure sensor (col. 5, lines 65-67), and apply a continual calculated tare adjustment to the sensed pressure during operation of the infusion pump to deliver infusate through the administration set, the tare adjustment to compensate for a decay of observable stress within the administration set as a result of stress relaxation (via normalization process via calculation to normalize force or pressure readings by accounting for the tube force, based on standard relaxation curve using a linear function of logarithmic time, see col. 3, lines 20-39; and the estimated tube force is subtracted from tube wall force measurement to determine actual fluid pressure, see col. 9, line 46 until col. 10, line 29 and see also Figs. 8A, 8B and the description for the additional specifics, col. 11 lines 25-27, col. 12 lines 1-9 measurements are taken throughout the process and are used for normalization calculations to update the pump control during operation). Olsen discloses that tube force factoring includes working parameters for the system (col. 10 lines 30-32) but do not specially disclose a non-linear adjustment. However, Emami et al. teach functions may be used to compensate for non-linear behavior in a delivery system which may relate to differences in line resistance or drifts in performance overtime ([0061]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use a non-linear adjustment as Olsen discloses factoring in working parameters and Emami et al. teach such parameters may be non-linear based on the properties of the system.
Claim 12. Olsen discloses the infusion system of claim 11, wherein the infusion pump comprises at least one of a peristaltic pump or a large volume pump (col. 4, lines 57-59 and Fig. 4A-4E; col. 6, line 28 until col. 8, line 28).
Claim 13. Olsen discloses the infusion system of claim 12, wherein the at least one pressure sensor comprises an upstream pressure sensor (44) positioned upstream of the drive mechanism, a downstream pressure sensor (42) positioned downstream of the drive mechanism, or a combination thereof (Fig. 1; col. 5, lines 40-47).
Claim 15. Olsen discloses a method, comprising:
monitoring at least one of an upstream pressure (via inlet sensor 44) and a downstream pressure (via outlet sensor 42) of an administration set via one or more sensors (Fig. 1; col. 5, lines 40-47);
calculating a continual tare adjustment based at least in part on data gathered from the one or more sensors (i.e., calculating tube force measurement, see col. 9, line 46 until col. 10, line 29 and see also Figs. 8A, 8B and the description for the additional specifics).
determining whether the calculated tare adjustment meets acceptance criteria (col. 7, line 66 until col. 8, line 13); and
applying, during operation of the infusion pump to deliver infusate through the administration set, the tare adjustment, the continual the calculated tare adjustment to data gathered from the one or more sensors to compensate for a decay of observable stress within the administration set as a result of stress relaxation (Figs. 8A, 8B; col. 9, line 46 until col. 10, line 29; i.e., via applying the determined tube force to normalize pressure readings due to the effect of the change of stress relaxation of the tube over time, see the detailed descriptions of Figs. 8A, 8B for the additional specifics, col. 11 lines 25-27, col. 12 lines 1-9 measurements are taken throughout the process and are used for normalization calculations to update the pump control during operation). Olsen discloses that tube force factoring includes working parameters for the system (col. 10 lines 30-32) but do not specially disclose a non-linear adjustment. However, Emami et al. teach functions may be used to compensate for non-linear behavior in a delivery system which may relate to differences in line resistance or drifts in performance overtime ([0061]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use a non-linear adjustment as Olsen discloses factoring in working parameters and Emami et al. teach such parameters may be non-linear based on the properties of the system.
Allowable Subject Matter
Claim 9 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Response to Arguments
Applicant’s arguments with respect to the claim(s) 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 for any teaching or matter specifically challenged in the argument. As noted above, the Examiner finds the application to be continual as it applied and updated over the use of the device.
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 EMILY L SCHMIDT whose telephone number is (571)270-3648. The examiner can normally be reached Monday through Thursday 7:00 AM to 4:30 PM.
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/EMILY L SCHMIDT/Primary Examiner, Art Unit 3783
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