DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 January 8, 2026 has been entered.
Response to Amendment
The Amendment filed December 22, 2025 has been entered. Claims 1 – 19 are pending in the application.
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 1 – 14 and 16 – 19 are rejected under 35 U.S.C. 103 as being unpatentable over Orr, Troy J (US 2008/0077068 – herein after Orr) in view of Lang, Volker (US 5,609,572 – herein after Lang).
In reference to claim 1, Orr teaches a pump diaphragm system (pumping system in figs. 12-16; see ¶225: “An embodiment of pumping system utilizing a double diaphragm pump is shown in FIGS. 12-15. FIG. 16 provides a schematic view of an embodiment of a system utilizing a double diaphragm pump”) for controlling a process fluid (see ¶231; process fluid = fluid within fluid source 238 in fig. 16) within a liquid processing system (pump assembly 450, in fig. 16), comprising:
[in the rejection below, figs. 12-16 are relied upon to the teach the pump diaphragm system with the double diaphragm pump arrangement 100 (shown in figs. 1-6B and 9A-9C)]
a) (see fig. 16) a pump arrangement (double diaphragm pump arrangement 100 as per figs. 1-6B and 9A-9C) comprising at least one inlet conduit (180i), at least one outlet conduit (180o), and a diaphragm pump (diaphragm pump = portion/part in the pump arrangement comprising of membrane and pump cavity; In Orr, diaphragm pump = 110+160+140a+140b in view of figs. 2 and 9B) that controls a fluid flow in said at least one inlet and outlet conduits (control of process fluid flow from fluid source 238 to fluid return 239 in view of fig. 16);
b) a first actuator (164a+164b in view of figs. 5 and 9B/9C and ¶243-¶244, ¶275, ¶277) that controls a movement of the diaphragm pump (110+160+140a+140b);
c) at least two check valve functionalities downstream and upstream of the diaphragm pump (see figs. 9B-9C: the claimed functionalities are provided by inlet valve 101i, inlet valve 102i, outlet valve 101o, outlet valve 102o; wherein inlet valves are upstream of the diaphragm pump 110+160+140a+140b and outlet valves are downstream of the diaphragm pump 110+160+140a+140b); and
d) a pneumatic control system (451, in fig. 12 or fig. 16) comprising pneumatic conduits (pneumatic conduits = conduits carrying motive fluid (air); in fig. 16, pneumatic conduits = conduits with supply ports A, B and conduits within the manifold mounting assembly 400 that connects with the asserted pump arrangement 100) interconnecting (in view of fig. 2 and fig. 16) a second actuator (220+230+210+212) of the pneumatic control system with the first actuator (164a+164b), the pneumatic conduits for interconnection being intermediated (being facilitated/enabled) by a connector unit (see fig. 14/fig. 15: manifold plate 410 being a connector unit) allowing for interchanging fluid lines {condition A} and/or a configuration of pneumatic conduits at a side of the pump arrangement (100) {condition B} [as per ¶229, ¶230: asserted pump arrangement 100 is interchangeable and pump control system 451 is reusable; see ¶243 and ¶303: the connector unit 410 has bosses 407 or bosses 414-416 (see figs. 14-16) that receives bosses 176a-d of the pump arrangement 100, thus claimed interchanging feature exists since new pump arrangement 100 can be coupled to the reusable pump control system 451, therefore condition A being met; furthermore the configuration of pneumatic conduits exists at a top side of pump arrangement 100 in view of fig. 16, therefore condition B being met as well];
wherein when the pump arrangement (100) is connected to the connector unit (410; as seen in fig. 16 or fig. 12), one or more connections (i.e. operative or fluidic connection) are formed, and a pump function (pump’s operation) is realized by periodically changing a pressure at the diaphragm pump (as discussed in ¶313-¶326); and
wherein the pump arrangement (100) is affixed to a cabinet (enclosure 454 in fig. 12) housing the liquid processing system (450) [in view of figs. 12 and 16: enclosure 454 houses the control system 451, thus the enclosure houses part of the asserted liquid processing system 450], and the connector unit (410, in view of figs. 12 and 14) is situated on an external panel (top surface) of said cabinet (454 in fig. 12), and
wherein the diaphragm pump (110+160+140a+140b) further comprises (see figs. 9B-9C) a stationary pump plate (110) and an opposing membrane (140a+140b) defining a pump chamber cavity (141a+141b) therebetween; and
wherein the connector unit (410; see figs. 12-16) is configured to connect and disconnect the pneumatic conduits (conduits with supply ports A, B and conduits within the manifold mounting assembly 400 that connects with the asserted pump arrangement 100) connecting the first actuator (164a+164b in view of figs. 5 and 9B/9C) and the second actuator (220+230+210+212, see fig. 16) of the pneumatic control system [the asserted connector unit 410 is capable of connecting and disconnecting the asserted pneumatic conduits that connects the asserted first actuator and the second actuator because (see ¶296, ¶303-¶305, figs. 12-16) component 410 (part of the manifold mounting assembly 400) is designed to “selectively couple and decouple” the disposable pump from the reusable control system].
Orr remains silent on the pump diaphragm system further comprising “a pump push element configured to directly contact the opposing membrane, where the contact between the pump push element and the opposing membrane forces the process fluid through the diaphragm pump of the pump diaphragm system to effectuate pumping of the process fluid through the pump diaphragm system, wherein the pump push element is spring loaded and comprises a pump push plate configured to contact the opposite membrane.”.
However, Lang teaches a pump diaphragm system (see fig. 3) comprising of a pump push element (piston 32+plunger tube 33+spring 35) configured to directly contact the opposing membrane (diaphragm 38), where the contact between the pump push element and the opposing membrane forces the process fluid through the diaphragm pump of the pump diaphragm system to effectuate (to cause) pumping of the process fluid (i.e. fluid to be pumped) through the pump diaphragm system (see col. 4, lines 25-37: “After the pump chamber has been completely filled, it is possible then, by entry of compressed air into a pump cylinder 30 through ports 31 and by pressure acting via a thrust plate 37 arranged on the floor of the roll diaphragm, for the pump chamber to be evacuated. The thrust plate 37 consists of ferromagnetic material. During evacuation of the pump chamber by means of the entering compressed air a piston 32, having a plunger tube 33 mounted thereon, is thrust against the force of a compression spring 35..”), wherein the pump push element (32+33+35) is spring loaded (in view of presence of spring 35) and comprises a pump push plate (32+33) configured to contact the opposite membrane (38).
Orr and Lang both teach a pump diaphragm system wherein the diaphragm is pneumatically actuated (in Orr, diaphragm is directly acted upon by compressed air (i.e. compressed air > diaphragm) while in Lang, diaphragm is indirectly acted upon by compressed air (i.e. compressed air > pump push element > diaphragm). It would have been obvious to the person of ordinary skill in the art before the effective filing date of the invention to substitute diaphragm’s actuation method in Orr’s system for the diaphragm’s actuation method that involves use of pump push element as taught by Lang in order to obtain the predictable result of actuating the diaphragm for pumping the fluid in the pump diaphragm system. KSR Int’l v. Teleflex Inc., 127 S. Ct. 1727, 1740-41, 82 USPQ2d 1385, 1396 (2007). Furthermore, for instance, a utilization of a spring allows the spring to act as a fail-safe mechanism or ensures complete intended return of the diaphragm (if hydraulic pressure is insufficient or momentarily lost, the spring ensure that the diaphragm still moves correctly in an intended direction, thus preventing improper operation or stalling).
In reference to claim 2, Orr teaches the pump diaphragm system, further comprising: a valve arrangement (in view of figs. 1, 2, 9B, 9C) comprising two or more inlet conduits (131i, 132i), an outlet conduit (131o, 132o), and a plurality of valve components (see figs. 9B, 9C: components such as inlet valves seats 111i, 112i; outlet valve seats 111o, 112o and portions of diaphragm 150a cooperating with the valve seats for allowing the process fluid to flow into and out of the pump chamber) capable of controlling the fluid flow in said two or more inlet conduits and the outlet conduit.
In reference to claim 3, Orr teaches the pump diaphragm system, wherein a configuration or spatial arrangement of said valve arrangement (arrangement comprising 131i, 132i, 131o, 132o, 111i, 112i, 111o, 112o, portions of diaphragm 151a) or said connector unit (410) are altered to change the pump diaphragm system's mode of operation [functional arrangement of the asserted valve arrangement/connector unit is altered (i.e. opening and closing state of the inlet and outlet valves in the valve arrangement or fluid lines in the connector unit is/are altered) for operating the pump arrangement 100 in the suction and discharge modes for pumping the process fluid].
In reference to claim 4, Orr teaches the pump diaphragm system, wherein a configuration of the connector unit (410) is altered to change the pump diaphragm system's mode of operation [functional arrangement of the asserted connector unit is altered (i.e. opening and closing state of the fluid lines in the connector unit are altered) for operating the pump arrangement 100 in the suction and discharge modes for pumping the process fluid].
In reference to claim 5, Orr teaches the pump diaphragm system, wherein a configuration of the pneumatic control system (451, in fig. 16) is altered to change the pump diaphragm system's (100) mode of operation [functional arrangement of the asserted pneumatic control system is altered (i.e. connection and disconnection states of the fluid lines with the pressure source 220 and/or vacuum source 230 in the pneumatic control system are altered) for operating the pump arrangement 100 in the suction and discharge modes for pumping the process fluid].
In reference to claim 6, Orr teaches the pump diaphragm system, wherein the second actuator (220+230+210+212) and the pneumatic conduits (pneumatic conduits = conduits carrying motive fluid (air), in fig. 16) of the pneumatic control system (451) are situated inside (in view of fig. 12) the cabinet (454) hosting the liquid processing system [the asserted the asserted cabinet houses various components of the control system 451 that hosts/controls the operation of the liquid processing system].
In reference to claim 7, Orr teaches the pump diaphragm system, wherein the pump diaphragm system (pumping system) is a single use unit [pumping system has pump assembly 450 which comprises of the control system 451 and pump 100; see ¶296: “The control system 451 and one or more diaphragm pumps 100, 100a can be configured to selectively couple and decouple. In some embodiments, the one or more diaphragm pumps 100, 100a can be used with the control system 451 in a single procedure or a limited number of procedures, removed from the control system 451, and then discarded”].
In reference to claim 8, Orr teaches the pump diaphragm system, wherein the pump diaphragm system (pumping system) is pre-sterilized [see ¶229: “Some embodiments of pumping systems that may be used in single-use disposable medical applications can advantageously be comprised of a removable and/or separable disposable pumping component and a reusable pump control system. The disposable pumping component can be packaged and pre-sterilized for use in a medical application related to an individual patient”].
In reference to claim 9, Orr teaches the pump diaphragm system, wherein the pump diaphragm system (pumping system) is provided as a closed and contained unit (as seen in fig. 12 for instance) with aseptic (sterilized) connectors (see figs. 9B, 9C and 13A: ports 176a, 176b, 176c, 176d) [see ¶229: “Some embodiments of pumping systems that may be used in single-use disposable medical applications can advantageously be comprised of a removable and/or separable disposable pumping component and a reusable pump control system. The disposable pumping component can be packaged and pre-sterilized for use in a medical application related to an individual patient”; thus, the connectors 176a, 176b, 176c, 176d of the pumping system being “aseptic connectors”].
In reference to claim 10, Orr teaches the pump diaphragm system, wherein the pump arrangement (100) is formed by two modules (one module being 110+170 and another being 160, in view of figs. 1, 2, 9B, 9C), wherein a first module (110+170) of the two modules comprises a wetted part (any one of the parts within 110 that comes in contact with pumped/process fluid; for instance inlet channel 138i) and a plurality of valve components (see figs. 9B, 9C: components such as inlet valves seats 111i, 112i; outlet valve seats 111o, 112o), and a second module (160) of the two modules comprises said first actuator (164a+164b in view of figs. 5 and 9B).
In reference to claim 11, Orr teaches the pump diaphragm system, wherein said first (110+170) and second (160) modules are secured by a clamping device or a clamping plate (see ¶235: “Components of a double diaphragm pump 100, such as the components shown in FIG. 2 can be assembled together in any other suitable manner, such as via mechanical fasteners (for example nuts and bolts, clamps, screws, etc.); adhesives; welding; bonding; or other mechanisms”).
In reference to claim 12, Orr teaches the pump diaphragm system, wherein the first module (110+170) is formed from a flexible pouch (flexible pouch = flexible material; 110 being formed from fluorinated ethylene propylene material), and wherein the first module is secured (first module 110+170 secured to second module 160) by a clamping device or a clamping plate [see ¶235: “In certain embodiments, the diaphragms 140a, b and 150a, b and pump body 110 can be fabricated with similar materials that will bond together when heated. In some embodiments, fluorinated ethylene propylene (FEP) materials can be used for both of the diaphragms 140a, b, 150a, b and the pump body 110, and heat can be used to bond the diaphragms to the body. Other heat sealable materials that can be used for both of the diaphragms 140a, b, 150a, b and the pump body 110 include polyvinylchloride (PVC), polyurethane (PU), and polypropylene (PP)” and “Components of a double diaphragm pump 100, such as the components shown in FIG. 2 can be assembled together in any other suitable manner, such as via mechanical fasteners (for example nuts and bolts, clamps, screws, etc.); adhesives; welding; bonding; or other mechanisms”].
In reference to claim 13, Orr teaches the pump diaphragm system, wherein (see figs. 9B, 9C) at least one valve (inlet valve 101i/102i and outlet valve 101o/102o) is formed as part of the pump arrangement (100) comprising a pump chamber (103a/103b) for achieving said pump function with a unidirectional displacement of the process fluid in said at least one inlet (180i) and outlet (180o) conduits of said liquid processing system [unidirectional displacement of liquid = displacement of process fluid from the inlet into the outlet].
In reference to claim 14, Orr teaches the pump diaphragm system, wherein the diaphragm pump (110+160+140a+140b) is attached to a support structure (170) [see figs. 9B/9C].
In reference to claim 16, Orr teaches the pump diaphragm system, wherein the connector unit (410) contains one or more positioning features (see ¶305 and fig. 14: 403a, 403b) to ensure proper alignment (with asserted pump arrangement 100) when connected [latches 403a, 403b interacts with mounting hook 175 on asserted pump arrangement 100].
In reference to claim 17, Orr teaches the pump diaphragm system, wherein the pump diaphragm system (pumping system) comprises at least one layer of single-use wetted parts [layer being pump body 110 which is wetted by process fluid and this pump body 110 is of single-use since it will be discarded along with the single-use pump diaphragm system 100; see ¶296: “The control system 451 and one or more diaphragm pumps 100, 100a can be configured to selectively couple and decouple. In some embodiments, the one or more diaphragm pumps 100, 100a can be used with the control system 451 in a single procedure or a limited number of procedures, removed from the control system 451, and then discarded”].
In reference to claim 18, Orr teaches a method of using the pump diaphragm system (pumping system) of claim 1 in a process for a purification of a biological material [see ¶327: “FIG. 17 is a schematic illustration of an embodiment of a cardiopulmonary by-pass system 700 that includes multiple double diaphragm blood pumps 100b-f. The system 700 can further include one or more reservoirs 706, blood oxygenators 701, fluid conduits, such as tubing segments 702, 705, catheters 704, 712, cannulae 703, 709, medical fluid sources 711, heat exchangers, and/or filtration units” or see ¶344:”In certain embodiments, for the portion of the circuit 800 between the patient P and the pump 100h, blood pressure can be measured and monitored by means of a pressure sensor, such as a piezo-resistive pressure transducer 804a that can be connected to the drip chamber 803, whereby a hydrophobic membrane filter (not shown) serves to prevent contamination of the blood”].
In reference to claim 19, Orr teaches a system for purifying a biological material [underlined limitation is an intended use of the system and thus not given a patentable weight; see MPEP 2111.02(II)], wherein the system comprises the pump diaphragm system (pumping system) of claim 1 [further note the intended use of the system 100 in Orr for purifying a biological material (blood) in view of disclosure in ¶327 or ¶344].
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Orr in view of Lang and Burke et al. (US 2009/0093797 – herein after Burke).
Orr teaches the pump diaphragm system, wherein (as seen in figs. 9B/9C) the diaphragm pump (110+160+140a+140b) is attached to the support structure (170).
Orr remains silent on the pump diaphragm system, wherein the diaphragm pump (110+160+140a+140b) is attached to the support structure (170) by laser welding, 2D injection molding or by overmolding.
Orr discloses (see ¶235): “Components of a double diaphragm pump 100, such as the components shown in FIG. 2 can be assembled together in any other suitable manner, such as via mechanical fasteners (for example nuts and bolts, clamps, screws, etc.); adhesives; welding; bonding; or other mechanisms”.
However, Burke teaches a laser welding being known technique to weld/seal two parts together (see ¶13).
Thus, it would have been obvious to the person of ordinary skill in the art before the effective filing date of the invention to attach the diaphragm pump and the support structure in the pump diaphragm system of Orr by laser welding as taught by Burke in order to ensure a secure and permanent connection between the components in the pump arrangement of Orr.
Response to Arguments
The arguments filed December 22, 2025 have been fully considered but they are not found to be persuasive. Upon further consideration of Orr, the newly added limitation in claim 1 is taught by Orr as discussed above.
The Applicant contends that the manifold plate 410 of Orr is merely provided to secure the diaphragm pump. However, Orr explicitly describes (see ¶296, ¶303-¶305, figs. 12-16) the manifold mounting assembly (400) as an interface that allows the disposable pump (100) to be “operatively associated” and “selectively coupled and decoupled” from the reusable control system (451). The manifold mounting assembly (400) of Orr has manifold plate (410) acts as the claimed “connector unit”. The assembly contains air transfer bosses (407) that receive corresponding air bosses (162a,b and 176a-d) from the pump (see ¶303).
The Applicant argues that connecting the pump to the unit does not suggest the unit is capable of connecting and disconnecting the pneumatic conduits. This is contradicted by the operational description in Orr. Orr teaches (see ¶309-¶310) that motive fluid (air) is transferred from the control system’s valves through the manifold base (410) and its air transfer bosses (411-416) directly into the pump’s actuators. Orr specifies that the pump components are “removable and/or separable” from the control system. When the pump is removed (decoupled), the pneumatic interface at the connector (manifold plate) is necessarily disconnected. When a new pump is attached (coupled), the pneumatic conduits are re-established through the “sealed fluid interfaces” at the bosses. The manifold plate (410) facilitating this modular attachment inherently “connects and disconnects” the pneumatic path between the second actuator (220+230+210+212) and the first actuator (164a+164b).
Conclusion
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/CHIRAG JARIWALA/Examiner, Art Unit 3746
/ESSAMA OMGBA/Supervisory Patent Examiner, Art Unit 3746