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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 16 January 2026 has been entered.
Claim Objections
Claims 1 and 12 are objected to because of the following informalities:
The term “the adapter plate with to the processing unit” should be corrected to use either the word “with” or the word “to” but not both.
Appropriate correction is required.
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, 2, 5-9 and 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Frigard (WO 2018158273) in view of Thom (US 20200269178).
With respect to claim 1, Frigard discloses a modular processing system for biopharmaceutical and chemical processes comprising at least one processing unit (Figure 6:300) to carry out a filtration step or a chromatography step. The processing unit is in communication with an adapter plate (Figure 1:100) and an external control device (Figure 1:220). The adapter plate is directly and fluidically connected to the processing unit, such that the adapter plate is upstream from the processing unit. The adapter plate includes at least one adapter channel (Figure 1:101) in which fluid flows from the adapter plate to the processing unit – i.e., from an inlet opening of the adapter plate to the processing unit in a downstream direction. The adapter plate further includes at least one multiway valve (Figure 1:180) and at least one pump (Figure 1:140) that are used to control fluid flow and pressure within the adapter plate. Frigard states that the adapter plate includes at least one sensor (Figure 1:120,150,170,190) coupled to the external control device so that measurement data obtained by the sensor can be read out and used to regulate conditions within the adapter plate and processing unit. This is taught on pages 4-7. The pumps and valves are controllable via respective actuators (Figure 2:144 and Figure 4c:142’) that are operated by the external control device based on data received from the sensors. Frigard, however, does not expressly state that termination brackets are provided, such that the at least one processing unit and the at least one adapter plate are held between the brackets.
Thom discloses a modular processing system for biopharmaceutical and chemical processes. The modular processing system includes at least one processing unit (Figure 6:22) for carrying out a filtration step and at least one adapter plate (Figure 6:23) directly connected to the processing unit. The adapter plate includes an adapter channel (Figure 3:5) through which at least one fluid can flow to the processing unit. Termination brackets (Figure 6:24 and Figure 6:25) support the processing unit and the adapter plate, such that the at least one processing unit and the at least one adapter plate are held between the brackets. This is described in paragraphs [0073]-[0076].
Before the effective filing date of the claimed invention, it would have been obvious to support the Frigard at least one processing unit and at least one adapter plate using termination brackets. As evidenced by Thom, it is well known in the art to dispose modular biopharmaceutical and chemical processing components between a cover plate and an end/base plate (i.e., “brackets”). Thom indicates that this provides mechanical support and protection to the processing unit and adapter plate, while also ensuring that they are property aligned during use. Thom teaches that cover plates and end plates are inexpensive, “can be manufactured with particularly little effort”, have “a simple geometry”, may be optically transparent to allow viewing of the processing unit, and may have openings to allow for fluid transfer and/or the insertion of instrumentation.
With respect to claim 2, Frigard and Thom disclose the combination as described above. Frigard shows in Figs. 7-9 that at least first and second processing units 400, 500, 600’ are fluidically connected to each other, such that fluid flows through an intervening adapter plate 100, 100’, 100’’. Fluid flow between the first and second processing units can be at least partially deflected in order to modify direction, flow rate, and/or pressure.
With respect to claim 5, Frigard and Thom disclose the combination as described above. Frigard further teaches that the sensors of the adapter plate are coupled to the external control device using a bus system (Figure 2:113).
With respect to claim 6, Frigard and Thom disclose the combination as described above. Frigard shows in Fig. 4c that an actuator (Figure 2:144 and Figure 4c:142’) is used to control the activity of the deflection element, pump and/or valve, wherein the actuator is an electrical, mechanical, pneumatic and/or hydraulic actuator.
With respect to claim 7, Frigard and Thom disclose the combination as described above. Frigard further states that the sensor may be a flow sensor, flow rate sensor, conductivity sensor, pressure sensor, pH sensor or a light absorbance sensor.
With respect to claims 8 and 9, Frigard and Thom disclose the combination as described above. Frigard states that the sensors may be powered using a cable or batteries (“the electrical power connections 111, could be omitted and the sensors could be made internally powered for example by means of batteries and thereby need just signal connections”).
With respect to claim 11, Frigard and Thom disclose the combination as described above. Frigard teaches that the adapter plate and all of its internal components (sensor, deflection element, pump, valve) may be configured as a single use device (“Since the units are formed wholly or predominantly from plastics material and can be supplied for use in substantially sterile hermetically sealed packaging, then they are suitable as single use devices”).
With respect to claim 12, Frigard discloses a method for centrally controlling a modular processing system for a biopharmaceutical or chemical process. At least one processing unit (Figure 6:300) is provided in communication with an adapter plate (Figure 1:100) and an external control device (Figure 1:220). The adapter plate is directly or indirectly fluidically connected to the processing unit and includes at least one adapter channel (Figure 1:101) in which fluid flows from the adapter plate to the processing unit. The adapter plate further includes at least one deflection element and valve (Figure 1:180) and pump (Figure 1:140) that are used to control fluid flow and pressure within the adapter plate. Frigard further states that at least one property of fluid flow in the adapter plate is detected using at least one sensor (Figure 1:120,150,170,190). The sensor is coupled to the external control device, such that measurement data from the sensor is read out and used to regulate conditions within the adapter plate and processing unit. This is taught on pages 4-7. Sensor data is processed in order to control the operation of the deflection element, valve and pump. Fluid flow through the adapter channel is deflected to a desired output using the at least one deflection element, and pressure and flow rate in the adapter channel is regulated using the valves and pump. The pumps and valves are controllable via respective actuators (Figure 2:144 and Figure 4c:142’) that are operated by the external control device based on data received from the sensors. Frigard, however, does not expressly state that termination brackets are provided, such that the at least one processing unit and the at least one adapter plate are held between the brackets.
Thom discloses a modular processing system for biopharmaceutical and chemical processes. The modular processing system includes at least one processing unit (Figure 6:22) for carrying out a filtration step and at least one adapter plate (Figure 6:23) directly connected to the processing unit. The adapter plate includes an adapter channel (Figure 3:5) through which at least one fluid can flow to the processing unit. Termination brackets (Figure 6:24 and Figure 6:25) support the processing unit and the adapter plate, such that the at least one processing unit and the at least one adapter plate are held between the brackets. This is described in paragraphs [0073]-[0076].
Before the effective filing date of the claimed invention, it would have been obvious to support the Frigard at least one processing unit and at least one adapter plate using termination brackets. As evidenced by Thom, it is well known in the art to dispose modular biopharmaceutical and chemical processing components between a cover plate and an end/base plate (i.e., “brackets”). Thom indicates that this provides mechanical support and protection to the processing unit and adapter plate, while also ensuring that they are property aligned during use. Thom teaches that cover plates and end plates are inexpensive, “can be manufactured with particularly little effort”, have “a simple geometry”, may be optically transparent to allow viewing of the processing unit, and may have openings to allow for fluid transfer and/or the insertion of instrumentation.
With respect to claim 13, Frigard and Thom disclose the combination as described above. Frigard shows in Figs. 7-9 that at least first and second processing units 400, 500, 600’ are fluidically connected to each other, such that fluid flows through an intervening adapter plate 100, 100’, 100’’. Fluid flow between the first and second processing units can be at least partially deflected in order to modify direction, flow rate, and/or pressure.
Claims 3, 4 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Frigard (WO 2018158273) in view of Thom (US 20200269178) as applied to claims 2 and 12, and further in view of Cuiffi (US 20140212964).
Frigard and Thom disclose the combination as described above. As previously discussed, Frigard teaches on pages 4-7 that the adapter plate includes at least one sensor (Figure 1:120,150,170,190) coupled to the external control device so that measurement data obtained by the sensor can be read out and used to regulate conditions within the adapter plate and processing unit. Frigard, however, does not expressly state that a sensor is also disposed in the processing unit in addition to the adapter plate.
Cuiffi discloses a modular processing system for biopharmaceutical and chemical processes comprising at least one processing unit (Figure 2:206) in communication with an adapter plate (Figure 2:204) and an external control device (Figure 1:112). The adapter plate is directly or indirectly fluidically connected to the processing unit and includes at least one adapter channel (Figure 4E:475) in which fluid flows from the adapter plate to the processing unit. The adapter plate further includes at least one deflection element and valve (Figure 4E:472) and pump (Figure 4E:471) that are used to control fluid flow and pressure within the adapter plate. Cuiffi teaches in paragraphs [0028]-[0036] that the adapter plate and the processing unit each include at least one sensor (Figure 1:106) that communicates with the external control device so that measurement data obtained by the sensor can be read out and used to regulate conditions within the adapter plate and processing unit. Cuiffi shows in Fig. 2 that at least first and second processing units 206(n) are fluidically connected to each other, such that fluid flows through the intervening adapter plate 204. Fluid flow between the first and second processing units can be at least partially deflected in order to modify direction, flow rate, and/or pressure. Cuiffi teaches that at least one sensor is embedded in the first processing unit, the second processing unit and the adapter plate in order to read out and control fluid flow conditions within the adapter plate and each processing unit.
Before the effective filing date of the claimed invention, it would have been obvious to dispose sensors within both the processing units and adapter plates taught by Frigard. Cuiffi shows that it is useful to take direct measurements from the processing unit in order to immediately respond to changing environmental conditions. Those of ordinary skill would have recognized that the provision of multiple sensors disposed at different locations would provide additional information and greater control over the biopharmaceutical and chemical process. A mere duplication of parts (here, sensors) that provides a predictable and/or cumulative result is generally considered to be prima facie obvious. See MPEP 2144.04.
Response to Arguments
Applicant's arguments filed 16 January 2026 have been fully considered but they are not persuasive.
Applicant argues that Frigard requires “two-way valves 180”, which is in contrast to the claims which require a strict unidirectional feed architecture. However, it is unclear where in the claims this alleged “strict unidirectional feed architecture” is presented. Claims 1 and 12 state that the adapter plate is “located upstream” from the processing unit, and that the “adapter plate has one or more adapter channels which fluidically connects at least one inlet opening of the adapter plate with the processing unit”. Claims 1 and 12 go on to say that fluid flows “from the at least one inlet opening of the adapter plate to the at least one processing unit in downstream direction”. None of this can be construed as a limitation requiring “strict unidirectional feed architecture”. Limitations that describe fluid flow in a first downstream direction do not preclude the possibility that a different fluid may flow at a same or different time in a second upstream direction. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., unidirectional downstream flow) are not recited in the rejected claims. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Furthermore, Frigard’s “two-way valves 180” do not exclude embodiments in which fluid passes unidirectionally from an upstream adapter plate to a downstream processing unit. Frigard’s valves allow for the possibility that there may sometimes be reverse flow during the treatment of certain processing units. In other words, Frigard teaches embodiments where fluid passes unidirectionally from an upstream adapter plate to a downstream processing unit in addition to embodiments where fluid passes bidirectionally between the adapter plate and processing unit. Again, there does not appear to be any limitation in the current set of claims that requires only unidirectional flow at all times.
It is important to note that limitations relating to flow direction represent intended use recitations that are afforded reduced patentable weight in the context of an apparatus claim. It is well established that apparatus claims cover what a device is, not what a device does. A claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed (here, flow direction) does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim.
Applicant additionally argues that the hoses and tubes 5, 10 of Frigard are external components and therefore prevent a direct connection between the adapter plate and the processing unit. However, it is noted that Frigard expressly states that the adapter plate and processing unit can be either directly or indirectly connected (“plural units 100 side by side such that their inlets and outlets can be connected either directly where possible, or can be connected by interconnecting fluid paths, such as tubes fitted to quick couplings or the like”). In the event that hoses and tubes 5, 10 are external components that promote an indirect connection, Frigard expressly states that hoses and tubes 5, 10 are not necessary, and that indirect connections are recognized as being functionally equivalent to and obvious variants of direct connections.
Applicant lastly argues that plate 22 of Thom is not a processing unit. It is believed that plate 22 is a processing unit because it holds a fluid to be filtered and supports a filter medium. Regardless, Thom is primarily cited as evidence that it is known in the art to provide modular processing units with termination brackets (e.g., end plates and base plates). Frigard is the primary reference and already discloses the particulars of the claimed processing unit and adapter plate. In response to Applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Conclusion
This is a non-final rejection.
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/NATHAN A BOWERS/Primary Examiner, Art Unit 1799