DETAILED ACTION
This is in response to the Amendment filed 8/13/2026 wherein claims 1-20 are presented for examination.
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 .
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.
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.
Claims 1-2, 10, 15-17, and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Olsen (US 5,695,473).
Regarding Independent Claim 1, Olsen teaches (Figures 1-10) an infusion system (20) comprising:
an infusion device (22, 32, 46),
an infusion set (26, 30, 36, 38, 54) comprising an infusion line (26, 30) with a first end (an end of line 26 connected to 24) and a second end (an end of line 26 connected to 54), and a backpressure regulator (36, 38) disposed between the first end (an end of line 26 connected to 24) and the second end (an end of line 26 connected to 54) of the infusion line (26, 30), the infusion device (22, 32, 46) configured to pump a medical fluid (25) through the infusion line (26, 30), and
a sensor assembly (42, 44) comprising a first sensor (42) disposed along the infusion line (26, 30) between the backpressure regulator (36, 38) and the second end (an end of line 26 connected to 54) of the infusion line (26, 30),
wherein the infusion device (22, 32, 46) comprises a controller (46) coupled to (via 48) the sensor assembly (42, 44).
Regarding Claim 2, Olsen teaches the invention as claimed and as discussed above. Olsen further teaches (Figures 1-10) wherein the controller (46) is configured to receive a signal from the first sensor (42), to determine if an occlusion has occurred downstream of the backpressure regulator (36, 38) based on the signal (via 48), and to control the infusion device to pause delivery of fluid (from 34) if an occlusion has occurred (Column 2, lines 36-45 and Column 7, line 45 – Column 8, line 13).
Regarding Claim 10, Olsen teaches the invention as claimed and as discussed above. Olsen further teaches (Figures 1-10) wherein the sensor assembly (42, 44) comprises a second sensor (44) disposed along the infusion line (26, 30) between the first end (an end of line 26 connected to 24) of the infusion line (26, 30) and the backpressure regulator (36, 38).
Regarding Claim 15, Olsen teaches the invention as claimed and as discussed above. Olsen further teaches (Figures 1-10) wherein the first sensor (42) is disposed outside (see Figure 1-3) the infusion line (26, 30).
Regarding Claim 16, Olsen teaches the invention as claimed and as discussed above. Olsen further teaches (Figures 1-10) wherein the infusion device (22, 32, 46) comprises a housing (62, 74), and the first sensor (42) is attached to the housing (62, 74; see Figures 1-3).
Regarding Claim 17, Olsen teaches the invention as claimed and as discussed above. Olsen further teaches (Figures 1-10) wherein the backpressure regulator (36, 38) is attached at least in part (see Figures 1-3) of the housing (62, 74).
Regarding Claim 19, Olsen teaches the invention as claimed and as discussed above. Olsen further teaches (Figures 1-10) wherein the first sensor (42) is a force sensor (see Column 5, lines 47-49).
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 3-6 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Olsen (US 5,695,473) in view of Kamen et al. (US 2019/0134297).
Regarding Claim 3, Olsen teaches the invention as claimed and as discussed above. Olsen does not teach, as discussed so far, wherein the backpressure regulator comprises a diaphragm and a biasing element that biases the diaphragm, wherein the biasing element is adjustable.
Kamen teaches (Figures 1-117) a backpressure regulator (4000; see Figures 48-53) that comprises a diaphragm (4060) and a biasing element (4010, 4020) that biases the diaphragm (4060), wherein the biasing element (4010, 4020) is adjustable (via 4090 or pressure from 4030).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Olsen to have the backpressure regulator comprises a diaphragm and a biasing element that biases the diaphragm, wherein the biasing element is adjustable, as taught by Kamen, in order to substantially reduce or prevent retrograde flow from a dispensing chamber into a pumping chamber (Paragraph 0380 of Kamen).
Regarding Claim 4, Olsen in view of Kamen teaches the invention as claimed and as discussed above. Olsen in view of Kamen does not teach, as discussed so far, wherein the biasing element is manually adjustable.
Kamen teaches (Figures 1-7) wherein the biasing element (4010, 4020) is manually adjustable (see Paragraph 0379).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Olsen in view of Kamen to have the biasing element be manually adjustable, as taught by Kamen, in order to allow adjustment of the pressure necessary to open the valve (Paragraph 0379 of Kamen).
Regarding Claim 5, Olsen in view of Kamen teaches the invention as claimed and as discussed above. Olsen in view of Kamen does not teach, as discussed so far, wherein the biasing element is automatically adjustable.
Kamen teaches (Figures 1-7) wherein the biasing element (4010, 4020) is automatically adjustable (via pressure from 4030; see Figures 48-56 and Paragraph 0379).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Olsen in view of Kamen to have the biasing element be automatically adjustable, as taught by Kamen, in order to allow the plunger to be freely displaced in response to increased fluid pressure in the fluid inlet (Paragraph 0379 of Kamen).
Regarding Claim 6, Olsen teaches the invention as claimed and as discussed above. Olsen does not teach, as discussed so far, wherein the backpressure regulator comprises a diaphragm and a biasing element that biases the diaphragm, wherein the biasing element is a spring.
Kamen teaches (Figures 1-117) a backpressure regulator (4000; see Figures 48-53) that comprises a diaphragm (4060) and a biasing element (4010, 4020) that biases the diaphragm (4060), wherein the biasing element (4010, 4020) is a spring (via 4010; see Figures 50-53).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Olsen to have the backpressure regulator comprises a diaphragm and a biasing element that biases the diaphragm, wherein the biasing element is a spring, as taught by Kamen, in order to substantially reduce or prevent retrograde flow from a dispensing chamber into a pumping chamber (Paragraph 0380 of Kamen).
Regarding Claim 18, Olsen teaches the invention as claimed and as discussed above. Olsen further teaches (Figures -10) the backpressure regulator (36, 38) comprises a first housing (40), the first housing (40) being part of the infusion line (26, 30), and a second housing (40), the second housing (74, 76) mounted on the infusion device (22, 32, 46). Olsen does not teach, as discussed so far, a diaphragm joined to the first housing and a biasing element in the second housing.
Kamen teaches (Figures 1-117) a backpressure regulator (4000) that comprises a first housing (annotated below) and a diaphragm (4060) joined to the first housing (annotated below), the first housing (annotated below) being part of the infusion line (4030, 4040), and a second housing (annotated below) and a biasing element (4010, 4020) in the second housing (annotated below).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Olsen to have the diaphragm joined to the first housing and the biasing element in the second housing, as taught by Kamen, in order to substantially reduce or prevent retrograde flow from a dispensing chamber into a pumping chamber (Paragraph 0380 of Kamen).
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Claims 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Olsen (US 5,695,473) in view of Kamen et al. (US 2019/0134297) and Perry et al. (US 2007/0253463).
Regarding Claim 7, Olsen teaches the invention as claimed and as discussed above. Olsen does not teach, as discussed so far, wherein the backpressure regulator comprises a diaphragm and a biasing element that biases the diaphragm, wherein the biasing element comprises a volume of compressed fluid.
Kamen teaches (Figures 1-117) a backpressure regulator (4000; see Figures 48-53) that comprises a diaphragm (4060) and a biasing element (4010, 4020) that biases the diaphragm (4060), wherein the biasing element (4010, 4020) is adjustable (via 4090 or pressure from 4030).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Olsen to have the backpressure regulator comprises a diaphragm and a biasing element that biases the diaphragm, wherein the biasing element is adjustable, as taught by Kamen, in order to substantially reduce or prevent retrograde flow from a dispensing chamber into a pumping chamber (Paragraph 0380 of Kamen). Olsen in view of Kamen does not teach that the biasing element comprises a volume of compressed fluid.
Perry teaches (Figures 1-87) a regulator (25, 2025, or 2000) comprising diaphragm (33, 2109, 2090) and a biasing element (42, 2106, 2096) that biases the diaphragm (33, 2109, 2090), wherein the biasing element (42, 2106, 2096) comprises a volume of compressed fluid (see Figures 4 and 20-21).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Olsen in view of Kamen to have the biasing element comprise a volume of compressed fluid, as taught by Perry, in order to change the position of the membrane (Paragraph 0261 of Perry).
It is further noted that a simple substitution of one known element (in this case, the spring used for biasing the diaphragm, as taught by Kamen) for another (in this case, the compressed fluid used for biasing the diaphragm, as taught by Perry) to obtain predictable results (in this case, to control the movement of the diaphragm) was an obvious extension of prior art teachings, KSR, 550 U.S. at 415-421, 82 USPQ2d at 1396, MPEP 2141 III B.
Regarding Claim 8, Olsen in view of Kamen and Perry teaches the invention as claimed and as discussed above. Olsen in view of Kamen and Perry does not teach, as discussed so far, wherein the volume is in fluid communication with a pump.
Perry teaches (Figures 1-87) wherein the volume (at 42) is in fluid communication with a pump (within 51, 52; see Paragraph 0254).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Olsen in view of Kamen and Perry to have the volume be in fluid communication with a pump, as taught by Perry, for the same reasons discussed above in claim 7.
Regarding Claim 9, Olsen in view of Kamen and Perry teaches the invention as claimed and as discussed above. Olsen in view of Kamen and Perry does not teach, as discussed so far, further comprising a sensor to determine the pressure of the fluid in the volume, the sensor coupled to the controller and the controller configured to operate the pump to vary the pressure of the fluid in the volume.
Perry teaches (Figures 1-87) a sensor (44) to determine the pressure of the fluid in the volume (Paragraph 0261), the sensor (44) coupled to a controller (49) and the controller (49) configured to operate the pump (see Paragraph 0254) to vary the pressure of the fluid in the volume (at 42; see Figure 4).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Olsen in view of Kamen and Perry to have a sensor to determine the pressure of the fluid in the volume, the sensor coupled to the controller and the controller configured to operate the pump to vary the pressure of the fluid in the volume, as taught by Perry, for the same reasons discussed above in claim 7.
Claims 11-14 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Olsen (US 5,695,473) in view of Wolff et al. (US 2019/0328963).
Regarding Claim 11, Olsen teaches the invention as claimed and as discussed above. Olsen teaches a sensor assembly (42, 44) comprising a first sensor (42) disposed along the infusion line (26, 30) between the backpressure regulator (36, 38) and the second end (an end of line 26 connected to 54) of the infusion line (26, 30) and a second sensor (44) disposed along the infusion line (26, 30) between the first end (an end of line 26 connected to 24) of the infusion line (26, 30) and the backpressure regulator (36, 38). Olsen does not teach, as discussed so far, wherein: the infusion device comprises a syringe including a barrel with an outlet end and a plunger, and a pusher device in engagement with the plunger, and the first end of the infusion line is in communication with the outlet end of the barrel, and the sensor assembly comprises a second sensor disposed between the plunger and the pusher device.
Wolff teaches (Figures 1-6) an infusion device (1) comprising a syringe (2) including a barrel (20) with an outlet end (at 30) and a plunger (21), and a pusher device (11) in engagement with (see Paragraph 0041) the plunger (21), and a first end of an infusion line (at 3) is in communication with the outlet end (at 30) of the barrel (20), and a sensor assembly comprising a sensor (14) disposed between the plunger (21) and the pusher device (11).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Olsen to have the infusion device comprises a syringe including a barrel with an outlet end and a plunger, and a pusher device in engagement with the plunger, and the first end of the infusion line is in communication with the outlet end of the barrel, and the sensor assembly comprises a second sensor disposed between the plunger and the pusher device, as taught by Wolff, in order to have the medical fluid be delivered out of the tube through a suitable delivery line towards a patient for infusing the medical fluid into the patient (Paragraph 0004 of Wolff).
Regarding Claim 12, Olsen in view of Wolff teaches the invention as claimed and as discussed above. Olsen in view of Wolff does not teach, as discussed so far, wherein the plunger comprises a first end disposed outside the barrel, and a second end with a piston disposed within the barrel, the second sensor disposed between the first end of the plunger and the pusher device.
Wolff teaches (Figures 1-6) that the plunger (21) comprises a first end (towards 210) disposed outside the barrel (20) and a second end with a piston (21; see Paragraph 0040 and Figure 1) disposed within the barrel (20; see Paragraph 0040 and Figure 1), the sensor (14) disposed between (see Figure 1) the first end of the plunger (21) and the pusher device (11).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Olsen in view of Wolff to have the plunger comprises a first end disposed outside the barrel, and a second end with a piston disposed within the barrel, the second sensor disposed between the first end of the plunger and the pusher device, as taught by Wolff, in order to have the medical fluid be delivered out of the tube through a suitable delivery line towards a patient for infusing the medical fluid into the patient and to measure a force when actuating the pusher device to push piston in the actuation direction into the cylindrical tube to deliver the medical fluid from the tube in a downstream direction towards the patient (Paragraphs 0004 and 0040 of Wolff).
Regarding Claim 13, Olsen in view of Wolff teaches the invention as claimed and as discussed above. Olsen in view of Wolff does not teach, as discussed so far, wherein the controller is configured to receive a signal from the second sensor, and to control the pusher device to deliver fluid from the syringe based on the signal.
Wolff teaches (Figures 1-6) a controller (15) that is configured to receive a signal from the sensor (14), and to control the pusher device (11) to deliver fluid from the syringe (2) based on the signal (from 14).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Olsen in view of Wolff to have the controller is configured to receive a signal from the second sensor, and to control the pusher device to deliver fluid from the syringe based on the signal, as taught by Wolff, in order to evaluate a substantial negative pressure in the delivery line and control the pusher device to pump a volume of fluid in the downstream direction to reinject the volume of fluid that has been reversely pumped (Paragraphs 0057-0062 of Wolff).
Regarding Claim 14, Olsen teaches the invention as claimed and as discussed above. Olsen does not teach, as discussed so far, wherein the infusion device comprises a volumetric pump.
Wolff teaches (Figures 1-6) an infusion device (1) comprises a volumetric pump (see Paragraphs 0003-0005).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Olsen to have the infusion device comprise a volumetric pump, as taught by Wolff, in order to pump a medical fluid in a peristaltic fashion through a delivery line in a downstream direction (Paragraphs 0002-0007 and 0028 of Wolff).
Regarding Claim 20, Olsen teaches the invention as claimed and as discussed above. Olsen does not teach, as discussed so far, wherein the first sensor is a pressure sensor.
Wolff teaches (Figures 1-6) a first sensor (14) being a pressure sensor (see Paragraph 0017).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Olsen to have the first sensor be a pressure sensor, as taught by Wolff, in order to measure a value indicative of a pressure in the delivery line, wherein a processor device is constituted to evaluate, measurement values obtained from the sensor device to identify a change in pressure in the delivery line (Paragraph 0017 of Wolff).
Response to Arguments
Applicant's arguments filed 8/13/2026 have been fully considered but they are not persuasive. Applicant argues that the Olsen’s valves are not part of an infusion set. In response and as discussed in the body of the rejection above, elements 26, 30, 36, 38, and 54 are interpreted as being included in the claimed “infusion set”. According to Applicant’s specification in Paragraph 0023, an infusion set can include elements such as valve 136. Therefore, Applicant’s argument that an infusion set cannot include a valve is refuted by Applicant’s originally filed disclosure.
Applicant also argues that the backpressure regulator regulates the pressure by remaining closed until the inlet pressure exceeds a threshold, at which point the fluid flows through the regulator outlet. Applicant additionally argues that valves 36, 38 do not truly regulate pressure or isolate the upstream elements from the downstream until the upstream pressure exceeds a set point. In response, it is noted that although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. In re Van Genus, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). The claims require a backpressure regulator “disposed between the first end and the second end of the infusion line”. As discussed in the body of the rejection above, Olsen teaches a backpressure regulator (36, 38) disposed between the first end (an end of line 26 connected to 24) and the second end (an end of line 26 connected to 54) of the infusion line (26, 30). It is further noted that Olsen’s valve 38 necessarily controls the pressure conditions because its operation directly produces and controls the pressure profile measured by sensor 42. It is further noted that Olsen’s valves 36, 38 are positioned such that they can isolate upstream elements from downstream elements (see Figure 1 of Olsen).
Claim 1 does not require the backpressure regulator to comprise a diaphragm and a biasing element that biases the diaphragm, wherein the biasing element is adjustable. Instead, this limitation is recited in claim 3. As detailed in the rejection above, Kamen teaches (Figures 1-117) a backpressure regulator (4000; see Figures 48-53) for an infusion device (see Figure 3) that comprises a diaphragm (4060) and a biasing element (4010, 4020) that biases the diaphragm (4060), wherein the biasing element (4010, 4020) is adjustable (via 4090 or pressure from 4030). Therefore, Applicant’s argument that the prior art does not teach a pressure regulator is refuted by the prior art.
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.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THOMAS P BURKE whose telephone number is (571)270-5407. The examiner can normally be reached M-F 8:30-5:00 PM.
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/THOMAS P BURKE/Primary Examiner, Art Unit 3741
