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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 April 27, 2026 has been entered.
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, 4-12, 15, 22, 31, 45-47, and 115 is/are rejected under 35 U.S.C. 103 as being unpatentable over Archibald (US 4,236,880) in view of DiPerna (US 2009/0191067 A1) and DiPerna et al. (US 2019/80009023 A1).
With regard to claims 1, 8, and 22, Archibald teaches a medical pump system, comprising: a reservoir cartridge assembly, comprising: a fluid reservoir (Fig. 1, Col. 4 lines 10, IV reservoir not shown), and a pump chamber assembly including: a pump chamber having an interior volume which is at least partially bounded by a pump housing (Figs. 3-7, volume bounded by housing 80a, 80a is taken as a pump housing), an inlet port in fluid communication between the interior volume and the liquid volume of the fluid reservoir (Figs. 3 and 7 port over 44), a resilient inlet membrane which is disposed adjacent the inlet port, which is spaced from the inlet port when in a relaxed state, and which is sufficiently distendable towards the inlet port to seal the inlet port when in a compressed state (Figs. 3B and 7 portion of 80b compressed by 44, Col. 5 lines 16-26), an outlet port in fluid communication between the interior volume and an outlet conduit (Figs. 3 and 7 port over 44, outlet conduit 16), a resilient outlet membrane which is disposed adjacent the outlet port, which is spaced from the outlet port when in a relaxed state, and which is sufficiently distendable towards the outlet port to seal the outlet port in a compressed state Figs. 3B and 7 portion of 80b compressed by 46, Col. 5 lines 27-37), a displacement chamber disposed within the interior volume, and a resilient displacement membrane which is disposed adjacent the displacement chamber, which forms at least a portion of a boundary of the displacement chamber, which is sufficiently inwardly distendable from a relaxed state to reduce the volume of the displacement chamber when in a compressed state, and which is sufficiently resilient to rebound and increase the volume of the displacement chamber when released from the compressed state (Figs. 3B and 7 chamber 24, membrane portion of 80b compressed by 38); and a reservoir base (18) and a pushrod guide (Fig. 7 guide 90 or alternatively 22) secured to the reservoir base, the pushrod guide including a rigid configuration, an inlet pushrod bore (Fig. 7 inlet bore 109 alternatively space in 22 above 109) disposed about and guiding an inlet pushrod (Fig. 7 inlet rod 108) which is operatively coupled to the resilient inlet membrane, a displacement pushrod bore (Fig. 7 displacement bore 111 alternatively space in 22 above 111) disposed about and guiding a displacement pushrod (Fig. 7 displacement rod 110) which is operatively coupled to the resilient displacement membrane and an outlet pushrod bore (Fig. 7 outlet bore 115 alternatively space in 22 above 115) disposed about and guiding an outlet pushrod (Fig. 7 outlet rod 114) which is operatively coupled to the resilient outlet membrane; and an actuator assembly that is configured to be operatively and releasably coupled to the reservoir cartridge assembly and later released and separated from the reservoir cartridge assembly, comprising: a cam assembly including an inlet cam lobe which is operatively coupled to the resilient inlet membrane (Fig. 7 member 98), an outlet cam lobe which is operatively coupled to the resilient outlet membrane (Fig.7 member 102, and a displacement cam lobe which is operatively coupled to the displacement membrane (Fig. 7 member 100) with the inlet cam lobe, outlet cam lobe and displacement cam lobe being configured and phased such that the resilient inlet membrane and resilient outlet membrane are never in an unsealed state at the same time during a complete rotation of the cam assembly (Col. 6 lines 47-49) and, a motor operatively coupled to the cam assembly (Fig. 7 member 94), and wherein the dispense cycle includes opening the outlet port while the inlet port is closed, compression of the displacement chamber while the outlet port is open and closing of the outlet port while the inlet port is still closed (see Col. 6 line 43-Col. 7 line 26). Archibald does not disclose details of the reservoir. However, DiPerna et al. ‘067 teach a reservoir connected to a flow regulator for dispensing fluid which comprises including a liquid volume (Fig. 1 120), an air volume (Fig. 1 110), a flexible membrane disposed and sealed between the liquid volume and air volume (Fig. 1 material of 120, [0016], [0019]), and a rigid outer structure which is resistant to flexing (Fig. 1 housing of 110, [0017]). Providing a two chamber pump is beneficial for controlling flow and measuring flow rate ([0002]-[0004]). 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 reservoir in Archibald as in DiPerna et al. ‘067 as this would be beneficial to provide greater control over the flow. DiPerna et al. ‘067 discloses a pressure sensor 115 in communication with the air volume (Fig. 1) but does not explicitly disclose determining a remaining volume based on measuring pressure drops. However, DiPerna et al. ‘023 teach information regarding a measured pressure drop over time in the air volume around a liquid reservoir may be used by a processor of a controller to determine an amount of liquid dispensed ([0077]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to connect the pressure sensor to a controller to determine volume as Diperna et al. ‘023 teach this is an effective means for determining the fluid delivered which necessarily also yields to fluid remaining. As combined the sensor would be active during the use of the device and would measure pressure drops during the dispense cycle of Archibald.
With regard to claims 4-6, the vent port is taken as the port in the area of 40, vent membrane is the membrane portion of 80b compressed by 40, vent cam 104, vent pushrod 116, and guide 90 with bore 117 (Fig. 7).
With regard to claim 7, see Figs. 3 and 7, the post-valve vent conduit is taken as 16 and the pre-valve vent conduit is taken as area 84.
With regard to claim 9, see the membranes as indicated in claim 1 above.
With regard to claim 10, see Fig. 7 shaft 96.
With regard to claims 11 and 12, see Col. 6 line 43-Col. 7 line 26.
With regard to claim 15, see Fig. 7 shaft 96.
With regard to claim 31, the circuitry and motor would necessarily require a power source which would necessarily require conductive conduits to transmit the electricity.
With regard to claim 45, see Figs. 2 and 7 member 22 showing the chassis (under this interpretation alternative considerations for the push rode guide are not relied upon).
With regard to claims 46 and 47, 19 is connected to the actuator assembly and provides a latch post which connects to latch spring 20 (Figs. 1 and 2, Col. 4 lines 31-35, 42-45). The latch spring would be capable of being permanently disabled.
With regard to claim 115, see Fig. 7, 109, 111, and 115 are all parallel and are in the same plane of the page.
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Archibald (US 4,236,880), DiPerna (US 2009/0191067 A1). and DiPerna et al. (US 2019/80009023 A1) as applied to claim 1 above.
With regard to claim 19, the speed of the motor is necessarily set which would determine a desired flow rate as such this would set an angular velocity to generate a maximum desired flow rate. Archibald do not teach a specific flow rate. However, Archibald teaches the conditions may be set to achieve a desired flow rate (Col. 15 lines 48-68). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to set the device to achieve a flow rate of .5 mL/s in Archibald as Archibald teach setting conditions to achieve a desired flow rate and it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980). One of ordinary skill would be able to set the controller to operate the motor to achieve the desired flow rate based on a desired therapy.
Claim(s) 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Archibald (US 4,236,880), DiPerna (US 2009/0191067 A1), and DiPerna et al. (US 2019/80009023 A1) as applied to claim 1 above, and further in view of Greene et al. (US 2005/0214129 A1).
With regard to claim 29, Archibald teaches a device substantially as claimed. Archibald does not disclose a position sensor coupled to the motor. However, Greene et al. teach a position sensor coupled to the motor which is used to calculate volume and adjust the pumping to compensate for variations (Fig. 1, abstract, [0035], [0048]). 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 position sensor in Archibald as Greene et al. teach it is beneficial for adjusting pumping if needed to maintain the proper dose delivery.
Claim(s) 41 is/are rejected under 35 U.S.C. 103 as being unpatentable over Archibald (US 4,236,880), DiPerna (US 2009/0191067 A1), and DiPerna et al. (US 2019/80009023 A1) as applied to claim 1 above, and further in view of Yamada et al. (US 5,499,909).
With regard to claims 41, Archibald teaches a device substantially as claimed. Archibald does not disclose a transmission. However, Yamada et al. teach using reduction gearing (Col. 10 line 25) which is known to increase torque. 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 transmission in Archibald as in Yamada et al. as this would increase torque output.
Claim(s) 114 is/are rejected under 35 U.S.C. 103 as being unpatentable over Archibald (US 4,236,880), DiPerna (US 2009/0191067 A1), and DiPerna et al. (US 2019/80009023 A1) as applied to claim 1 above, and further in view of Greene et al. (US 2005/0214129 A1).
With regard to claim 114, Archibald teaches a device substantially as claimed. Archibald does not disclose the volume delivered. However, Greene et al. teach a medical pump and that some treatments require low volumes including 2 microliters ([0021], [0068]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to deliver a volume of about 2 microliters with the pump of Archibald as Greene et al. teach such to a known treatment volume. Further, it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. One or ordinary skill would understand the amount delivered varies based on the drug delivered and specific patient parameters.
Claim(s) 116 is/are rejected under 35 U.S.C. 103 as being unpatentable over Archibald (US 4,236,880), DiPerna (US 2009/0191067 A1), and DiPerna et al. (US 2019/80009023 A1) as applied to claim 1 above, and further in view of Mann et al. (US 4,808,167).
With regard to claim 116, Archibald teaches a device substantially as claimed. Archibald does not disclose a latch which is permanently disabled to prevent subsequent coupling of the reservoir cartridge assembly to the actuator assembly. However, Mann et al. teach a reservoir cartridge assembly (Fig. 2 member 12) which connects to an actuator assembly (Fig. 2 member 10) with a latch 88 which is broken by a portion 90 of the actuator assembly which prevents reusing the same cartridge (Fig. 2, Col. 8 lines 24-54). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to house the cartridge assembly in a structure with an incorporated latch as in Mann et al. as this is beneficial to ensure sterility and safety (Col. 2 lines 3-40 of Mann et al.). As combined the device of Archibald would be modified to include the latching and switching components of Mann et al. which prevent reuse. Including portion 80A of Archibald would be fit with a corresponding housing to contain the latch and other associated features and would also provide a pushrod guide, opening to accommodate the pushrods of Archibald would be provided (as in Mann et al. when 40 is able to fit through). Further, as combined the reservoir portion includes a battery which is beneficial for ensuring proper use and prevention contamination (Col. 3 lines 41-50 of Mann et al.).
Response to Arguments
Applicant's arguments filed April 27, 2026 have been fully considered but they are not persuasive. Applicant again argues that Diperna ‘023 does not measure pressure during a dispense cycle. The valve positions as claimed for the dispense cycle are provided by Archibald. The claim does not prevent additional fluid movements or valve positions from being considered. Further, the teachings of Diperna ‘023 are applied to the pump process of Archibald and when combined would sense fluid during use of the device. Applicant argues the Examiner’s mapping to the pushrod guide being portion 90 is inconsistent as the structure also houses components of the actuator assembly. Structure 90 is distinguished and separate from the other listed components. Though it may have a relative relationship with those components this is not prevented by the claim. There is nothing in the claim which particularly structurally contains features of the reservoir cartridge assembly as distinguished from the actuator assembly. They both comprise a listing of parts. The parts relied upon are capable of being coupled and separated as required by claim 1. The Examiner would also note alternative considerations to the pushrod guide in claim 1 and in claim 116. Nothing in claim 1 or 45-47 discuss structures which are used for coupling/re-coupling in a way that distinguishes over Archibald. For example, claim 47 speaks to a prevention of reuse involving the latch spring, the device of Archibald is capable of having the latch spring permanently disabled. Applicant notes the claim recites the latch spring is configured to be permanently disabled, the claim does not recite how, as such this does not distinguish over the fact that 20 may be broken. The claim does not recite how the disabling occurs. 19 extends from 22 and 20 is on 18 which is taken as the base. 20 is a resilient biased member and as such is considered a spring.
Conclusion
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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