DETAILED ACTION
This action is in response to the amendments and remarks filed 11/12/2025, in which claims 1, 3, 8-9, 11, 20 and 24 have been amended; claim 28-33 have been newly added, and claims 1-3, 6-11, 16-18, 20, 24 and 28-33 are pending and ready for examination.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-3, 6-11, 16-18, 20, 24 and 28-33 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1 and 24 recite the limitation “when the negative pressure buffer chamber is working”. This limitation is indefinite as it is not clear what “working” is supposed to mean in this context, as it could mean functioning, or imply a specific fluid flow. Correction is required.
Claim 32 recites the limitations “a time difference between the first and the second time”, “a flow rate of the solution”; these conflict with the same terms in claim 20. The suggested correction is to amend to “the time difference between the first and the second time”, “the flow rate of the solution”.
Claims 2-3, 6-11, 16-18, 20 and 28-33 are rejected for depending from an indefinite claim.
Claim Rejections - 35 USC § 103
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 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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 6, 9, 11, 16, 20, 24, 29-30 and 32 are rejected under 35 U.S.C. 103 as being unpatentable over US 2014/0342446 Al (hereinafter “Pralong”) in view of US 11,459,535 B1 (hereinafter “Yeh”), JP 2003325160 A (hereinafter “Doi”) and CN 113457373 A (hereinafter “Yang”).
Regarding Claim 1 Pralong discloses a biological filtration system for filtering a solution in a bioreactor 1, comprising:
a filter device 6/8 having a top end and a bottom end, the top end being in fluid communication with the bioreactor 1 for filtering the solution in the bioreactor;
a liquid chamber 17 in fluid communication with the bottom end for storing a solution in the filter device;
a positive pressure source (which may be compressed air [0066]), in fluid communication with the liquid chamber 17, for driving the solution to flow from the liquid chamber to the bioreactor; and
a negative pressure source/vacuum injector 36 (can be generated by vacuum pump [0072]), in fluid communication with the liquid chamber 17, for driving the solution to flow from the bioreactor to the liquid chamber; Fig. 1, [0059]-[0075].
Pralong does not disclose (1) the compressed air positive pressure source is a positive pressure pump or (2) a negative pressure buffer chamber, wherein the negative pressure buffer chamber is disposed on a flow path between the negative pressure pump and the liquid chamber; the negative pressure buffer chamber is configured to control a rising height of the solution in the liquid chamber, and when the negative pressure buffer chamber is working, the flow path between the negative pressure buffer chamber and the negative pressure pump is in a non-conducting state.
However, with regard to (1) a positive pressure pump, Yeh discloses a gas compressor or pump (i.e. a positive pressure pump) is a known source of compressed air (C5/L41-45).
Therefore, before the effective filing date, it would have been prima facie obvious to one of ordinary skill in the art to modify the filter system of Pralong by using for the source of pressurized air a gas compressor or pump as disclosed by Yeh because a gas compressor or pump is a known source of compressed air.
With regard to (2) a negative pressure buffer chamber, Doi discloses a similar system which applies alternating positive and negative pressure to the liquid cell culture in an incubator, wherein it is disclosed that along with a vacuum pump “in order to rapidly reduce the pressure inside the incubator, it is also desirable to use a buffer tank such as a vacuum tank” (pg. 3, para. starting “The gas exhaust device 30 includes…”), wherein the vacuum buffer tank is a negative pressure buffer chamber (NPBC).
Therefore, before the effective filing date, it would have been prima facie obvious to one of ordinary skill in the art to modify the filter system of Pralong by including a vacuum buffer tank as disclosed by Doi in order to rapidly reduce the pressure inside the incubator.
Pralong in view of Yeh and Doi do not discloses the specific placement of the vacuum buffer tank.
However, Yang discloses a similar system using alternating positive and negative pressure applied to vessels (adsorption towers) which uses a vacuum pump P1 and vacuum buffer tank V2 with associated control valve H1, where the vacuum pump is connected with the vessels through a vacuum pipeline, and the vacuum pipeline is connected with the vacuum buffer tank through a branch pipe i.e. with the vacuum buffer tank disposed on a flow path between the vacuum pump and the vessels (Abstract, Claims, pg. 2 para. starting “According to the efficiency curve…”, Figures).
Therefore, before the effective filing date, it would have been prima facie obvious to one of ordinary skill in the art to modify the filter system of Pralong in view of Yeh and Doi by including the vacuum buffer tank disposed on a flow path between the vacuum/negative pressure pump and the vessel (i.e. liquid chamber) and a control valve on a flow path between the vacuum/negative pressure pump and the vacuum buffer tank/NPBC as disclosed by Yang because this a known arrangement which allows the vacuum pump and vacuum buffer tank to quickly provide vacuum to the vessels and the utilization efficiency of the vacuum pump is higher, the power consumption of equipment is small, and more energy is saved (pg. 2 para. starting “According to the efficiency curve…”). Thus resulting in a negative pressure buffer chamber, wherein the negative pressure buffer chamber is disposed on a flow path between the negative pressure pump and the liquid chamber
Wherein the vacuum/negative pressure is used in Pralong (and thus the combined invention) to control a rising height of the solution in the liquid chamber and thus the negative pressure buffer chamber is configured to control a rising height of the solution in the liquid chamber.
With regard to the limitation “when the negative pressure buffer chamber is working, the flow path between the negative pressure buffer chamber and the negative pressure pump is in a non-conducting state” this is a functional limitation. Claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function (see MPEP 2114), and thus the prior art need only disclose structure capable of achieving the recited function(s) to read on the functional limitations. These functional limitations do not further define over the prior art because the structure disclosed by Pralong in view of Yeh, Doi and Yang would be capable of the noted functional limitation(s), i.e. even though the specific functions are not disclosed, because the vacuum pump may be shut off and valve H1 provided for the vacuum buffer tank/NPBC may be closed, either of which will allow the flow path between the negative pressure buffer chamber and the negative pressure pump to be in a non-conducting state. Thus the arrangement claimed is one of a finite number of possible arrangements of the system, and would be functionally able to be operated as claimed.
Regarding Claim 9 Pralong in view of Yeh, Doi and Yang discloses the biological filtration system of claim 1, wherein the biological filtration system further comprises a first sensor LSH 26, wherein the first sensor is configured to detect liquid level information in the liquid chamber 17 and is disposed on a top portion of the liquid chamber at a preset interval,
a second sensor LSL 25, configured to detect the liquid level information in the liquid chamber and disposed on a bottom portion of the liquid chamber; Fig. 1, [0069].
Regarding Claim 11 Pralong in view of Yeh, Doi and Yang discloses the biological filtration system of claim 1, the biological filtration system further comprises a gas purifier (sterile filter 21) disposed on a flow path connecting the positive pressure pump and the negative pressure pump in the liquid chamber [0026].
Regarding Claim 16 Pralong in view of Yeh, Doi and Yang discloses the biological filtration system of claim 1, wherein the biological filtration system further comprises a first pressure regulating device 44 and a second pressure regulating device 42, wherein the first pressure 44 regulating device is disposed at an outlet of the positive pressure pump and is used to adjust a pumping gas pressure of the positive pressure pump, and the second pressure regulating device 42 is disposed at an outlet of the negative pressure pump and is used to adjust a suction gas pressure of the negative pressure pump [0074].
Regarding Claim 20 Pralong in view of Yeh, Doi and Yang discloses the biological filtration system of claim 1, further comprising a gas flow controller 28 configured to:
obtain a first liquid level signal (i.e. from the LSH 26) in the liquid chamber 17;
control the positive pressure source/pump to drive the solution in the filter device to flow to the bioreactor based on the first liquid level signal (i.e. backflushing the filter);
obtain a second liquid level signal (i.e. from LSL 25) in the liquid chamber 17; and
control the negative pressure source/pump to drive the solution in the bioreactor 1 to flow to the filter device based on the second liquid level signal; Fig. 1, [0069]-[0075], particularly [0073]; and
measure the time spent by the medium between the LSL level and the LSH level, to determine if the membrane has clogged, and adjusting the medium flow rate in order to unclog the membrane [0075]. While it is not specifically disclosed how the controller measures the time spent by the medium between the LSL level and the LSH level, this would obviously or inherently be done by obtaining a first time of triggering the first liquid level signal, obtaining a second time of triggering the second liquid level signal and calculating a time difference between the first time and the second time, as there are no other means given to calculate this time.
The flow controller is not specifically disclosed to comprise a processor, however a processor must be inherent in order to achieve the actions disclosed to be accomplished by the gas flow controller 28. See MPE 2112 with regard to inherency.
Regarding Claim 24 Pralong discloses a controlling method for a biological filtration system, wherein the biological filtration system comprises
a filter device 6/8 having a top end and a bottom end, the top end being in fluid communication with the bioreactor 1 for filtering the solution in the bioreactor;
a liquid chamber 17 in fluid communication with the bottom end for storing a solution in the filter device;
a positive pressure source (which may be compressed air [0066]), in fluid communication with the liquid chamber 17, for driving the solution to flow from the liquid chamber to the bioreactor; and
a negative pressure source/vacuum injector 36 (can be generated by vacuum pump [0072]), in fluid communication with the liquid chamber 17, for driving the solution to flow from the bioreactor to the liquid chamber; Fig. 1, [0059]-[0075].
the controlling method comprises:
obtaining a first liquid level signal i.e. from the LSH 26) in the liquid chamber;
controlling the positive pressure source to drive the solution in the filter device 6 to flow to the bioreactor 1 based on the first liquid level signal (i.e. backflushing the filter);
obtaining a second liquid level signal (i.e. from LSL 25) in the liquid chamber 17; and
controlling the negative pressure source/pump to drive the solution in the bioreactor 1 to flow to the filter device 6 based on the second liquid level signal; Fig. 1, [0069]-[0075], particularly [0073].
Pralong does not disclose (1) the compressed air positive pressure source is a positive pressure pump or (2) a negative pressure buffer chamber, wherein the negative pressure buffer chamber is disposed on a flow path between the negative pressure pump and the liquid chamber; the negative pressure buffer chamber is configured to control a rising height of the solution in the liquid chamber, and when the negative pressure buffer chamber is working, the flow path between the negative pressure buffer chamber and the negative pressure pump is in a non-conducting state.
However, with regard to (1) a positive pressure pump, Yeh discloses a gas compressor or pump (i.e. a positive pressure pump) is a known source of compressed air (C5/L41-45).
Therefore, before the effective filing date, it would have been prima facie obvious to one of ordinary skill in the art to modify the filter system of Pralong by using for the source of pressurized air a gas compressor or pump as disclosed by Yeh because a gas compressor or pump is a known source of compressed air.
With regard to (2) a negative pressure buffer chamber, Doi discloses a similar system which applies alternating positive and negative pressure to the liquid cell culture in an incubator, wherein it is disclosed that along with a vacuum pump “in order to rapidly reduce the pressure inside the incubator, it is also desirable to use a buffer tank such as a vacuum tank” (pg. 3, para. starting “The gas exhaust device 30 includes…”), wherein the vacuum buffer tank is a negative pressure buffer chamber (NPBC).
Therefore, before the effective filing date, it would have been prima facie obvious to one of ordinary skill in the art to modify the filter system of Pralong by including a vacuum buffer tank as disclosed by Doi in order to rapidly reduce the pressure inside the incubator.
Pralong in view of Yeh and Doi do not discloses the specific placement of the vacuum buffer tank.
However, Yang discloses a similar system using alternating positive and negative pressure applied to vessels (adsorption towers) which uses a vacuum pump P1 and vacuum buffer tank V2 with associated control valve H1, where the vacuum pump is connected with the vessels through a vacuum pipeline, and the vacuum pipeline is connected with the vacuum buffer tank through a branch pipe i.e. with the vacuum buffer tank disposed on a flow path between the vacuum pump and the vessels (Abstract, Claims, pg. 2 para. starting “According to the efficiency curve…”, Figures).
Therefore, before the effective filing date, it would have been prima facie obvious to one of ordinary skill in the art to modify the filter system of Pralong in view of Yeh and Doi by including the vacuum buffer tank disposed on a flow path between the vacuum/negative pressure pump and the vessel (i.e. liquid chamber) and a control valve on a flow path between the vacuum/negative pressure pump and the vacuum buffer tank/NPBC as disclosed by Yang because this a known arrangement which allows the vacuum pump and vacuum buffer tank to quickly provide vacuum to the vessels and the utilization efficiency of the vacuum pump is higher, the power consumption of equipment is small, and more energy is saved (pg. 2 para. starting “According to the efficiency curve…”). Thus resulting in a negative pressure buffer chamber, wherein the negative pressure buffer chamber is disposed on a flow path between the negative pressure pump and the liquid chamber
Wherein the vacuum/negative pressure is used in Pralong (and thus the combined invention) to control a rising height of the solution in the liquid chamber and thus the negative pressure buffer chamber is configured to control a rising height of the solution in the liquid chamber.
With regard to the limitation “when the negative pressure buffer chamber is working, the flow path between the negative pressure buffer chamber and the negative pressure pump is in a non-conducting state” this is a functional limitation. Claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function (see MPEP 2114), and thus the prior art need only disclose structure capable of achieving the recited function(s) to read on the functional limitations. These functional limitations do not further define over the prior art because the structure disclosed by Pralong in view of Yeh, Doi and Yang would be capable of the noted functional limitation(s), i.e. even though the specific functions are not disclosed, because the vacuum pump may be shut off and valve H1 provided for the vacuum buffer tank/NPBC may be closed, either of which will allow the flow path between the negative pressure buffer chamber and the negative pressure pump to be in a non-conducting state. Thus the arrangement claimed is one of a finite number of possible arrangements of the system, and would be functionally able to be operated as claimed.
Regarding Claim 29 Pralong in view of Yeh, Doi and Yang discloses the biological filtration system of claim 1, and with regard to the limitation “wherein the flow path between the negative pressure buffer chamber and the liquid chamber is in the non-conductive state, a flow path between the negative pressure buffer chamber and the negative pressure pump is in a conductive state, the negative pressure pump provides a negative pressure to the negative pressure buffer chamber” this is a functional limitation. Claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function (see MPEP 2114), and thus the prior art need only disclose structure capable of achieving the recited function(s) to read on the functional limitations. These functional limitations do not further define over the prior art because the structure disclosed by Pralong in view of Yeh would be capable of the noted functional limitation(s), i.e. even though the specific functions are not disclosed, because Pralong discloses a control valve 41 in the flow path between the negative pressure source (i.e. the NPBC in the combined invention) and the liquid chamber which is obviously/necessarily either open or closed and thus may be in the non-conductive state, and wherein a flow path between the negative pressure source/NPBC may obviously be in a conductive state, and the negative pressure pump (i.e. inherently, and as discussed supra) provides a negative pressure to the negative pressure buffer chamber. Thus the arrangement claimed is one of a finite number of possible arrangements of the system, and would be functionally able to be operated as claimed.
Regarding Claim 30 Pralong in view of Yeh, Doi and Yang discloses the biological filtration system of claim 29, but does not disclose wherein a second pressure regulating device is disposed between the negative pressure pump and the negative pressure buffer chamber, and the second pressure regulating device is used to control a suction gas pressure of the negative pressure pump to the negative pressure buffer chamber; when a pressure in the negative pressure buffer chamber reaches a preset pressure value, the second pressure regulating device is switched to a closed state, so that the flow path between the negative pressure pump and the negative pressure buffer chamber is in the non-conductive state, and the negative pressure pump stops working, and the negative pressure buffer chamber forms a negative pressure corresponding to the preset pressure value.
However, Yang discloses vacuumizing the vacuum buffer tank to reduce the pressure to a setpoint (i.e. 45-50 kPa), and discloses opening and closing valve H1 (a second pressure regulating device disposed between the negative pressure pump and the negative pressure buffer chamber) to control the pressure of the negative pressure pump to the negative pressure buffer chamber and thus in the vacuum buffer tank/NPBC and closing it depending on the pressure of the NPBC and what parts of the cycle the system is in (last paragraph of Example 5).
Therefore, before the effective filing date, it would have been prima facie obvious to one of ordinary skill in the art to modify the filter system of Pralong in view of Yeh, Doi and Yang by including the valve H1 (i.e. disposed between the negative pressure pump and the negative pressure buffer chamber) to control the pressure to and in the NPBC and closing it when the NPBC has reached desired pressure (i.e. thereby when a pressure in the negative pressure buffer chamber reaches a preset pressure value, the second pressure regulating device is switched to a closed state, so that the flow path between the negative pressure pump and the negative pressure buffer chamber is in the non-conductive state) and the negative pressure buffer chamber forms a negative pressure corresponding to the preset pressure value as disclosed by Yang because this allows the pressure in the NPBC to be controlled to a specific value to provide the liquid chamber with appropriate desired pressure.
It is not disclosed that the negative pressure pump stops working when the preset pressure value is reached, however this would have been obvious since the pressure has been reached an non more vacuum is needed.
Regarding Claim 32 Pralong in view of Yeh, Doi and Yang discloses the biological filtration system of claim 20, wherein, as discussed above in the rejection of claim 20, Pralong discloses the processor identifying variations in speed and then controlling the positive and negative pressure cycle to adjust the medium flow rate [0075], where it would have been obvious to do so based on a time difference between the first time and the second time.
Pralong does not disclose the processor is configured to compare the time difference with a preset time difference; if the time difference is less than the preset time difference, control a pressure regulating device of the biological filtration system to reduce pressure to reduce the flow rate of the solution; and if the time difference is greater than the preset time difference, control the pressure regulating device to increase the pressure to increase the flow rate of the solution.
However, as it is disclosed that variation in flow speed, and thus time difference between the first time and the second time, are used to determine clogging ([0075], supra), it would have been obvious to compare the time difference to a preset value, in order to determine if the value is out of range, i.e. of normal or desired flow speed, and thus time.
With regard to what to do after determining that the value is out of range, it is disclosed that the media flow rate may be adjusted by control of the positive and negative pressure [0075], but does not disclose whether that is to increase or decrease the flow speed. However, there are a finite number of solutions, i.e. the time difference must necessarily be above or below the preset value, and the speed adjustment must necessarily be either to increase or decrease speed, where obviously/necessarily in order to increase speed pressure would be increased or decreased and to decrease pressure would be would be increased or decreased. As no specific direction is given, it would have been obvious to try any of those possible, finite options. Thus it would have been obvious to configure to processor to compare the time difference with a preset time difference; if the time difference is less than the preset time difference, control a pressure regulating device of the biological filtration system to reduce pressure to reduce the flow rate of the solution; and if the time difference is greater than the preset time difference, control the pressure regulating device to increase the pressure to increase the flow rate of the solution as claimed.
Claims 2-3, 6, 10 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Pralong in view of Yeh, Doi and Yang further in view of US 20100078395 A1 (hereinafter “Shevitz”).
Regarding Claims 2-3 Pralong in view of Yeh, Doi and Yang discloses the biological filtration system of claim 1, but does not disclose (claim 2) wherein the filter device comprises a filter portion and a storage portion, wherein the filter portion is disposed close to the bottom end of the filter device, the storage portion is disposed close to the top end of the filter device, the storage portion is configured as a hollow chamber to form the liquid chamber, and the storage portion is in direct communication with the filter portion., or (claim 3) wherein the liquid chamber comprises a single chamber that directly interfaces with the top end of the filter device.
However Shevitz a similar filter for alternating flow filtration of living cell solutions, wherein gas positive or negative pressure applied to a liquid chamber causes liquid to flow in and out of the filter for tangential flow filtration, wherein the filter device comprises a filter portion 17 and a storage portion 7/8, wherein the filter portion is disposed close to the bottom end of the filter device, the storage portion is disposed close to the top end of the filter device, the storage portion is configured as a hollow chamber to form the liquid chamber 7, and the storage portion is in direct communication with the filter portion (as they are attached/integral), wherein the liquid chamber comprises a single chamber that directly interfaces with the top end of the filter device (as they are attached/integral), see Fig. 1, 2, Abstract, [0114], and discloses this arrangement as an alternative to one where the liquid chamber is separate from the filter and connected by a conduit, see Fig. 16.
Therefore, before the effective filing date, it would have been prima facie obvious to one of ordinary skill in the art to modify the filter system of Pralong in view of Yeh, Doi and Yang by integrating the liquid chamber with the filter device by incorporating it into the filter as disclosed by Shevitz because this is a known alternative arrangement to a separate liquid chamber connected by a conduit. While it is noted that in Pralong the liquid chamber is connected to the bottom of the filter, as Shevitz shows the liquid chamber which drives fluid flow is on the top, and supplying fluid to the top, it would have been obvious to arrange the filter so that the liquid chamber is incorporated into the top of the filter, i.e. inverting the filter of Pralong because this is a known alternative arrangement of such filters, and because there is no criticality placed on the orientation of the filter of Pralong. Thus resulting in wherein the liquid chamber comprises a single chamber that directly interfaces with the top end of the filter device
Regarding Claim 6 Pralong in view of Yeh, Doi, Yang and Shevitz discloses the biological filtration system of claim 2, wherein the biological filtration system comprises a first conduit, wherein the bottom end of the filter device (i.e. because it is inverted from as shown in the figure, see rejection of claim 2 supra) is connected to the bioreactor through the first conduit, the positive pressure pump is used to drive the solution in the filter device to flow to the bioreactor along the first conduit, and the negative pressure pump is used to drive the solution in the bioreactor to flow to the filter device along the first conduit (Fig. 1).
Regarding Claim 10 Pralong in view of Yeh, Doi and Yang discloses the biological filtration system of claim 1, but does not disclose wherein the biological filtration system further comprises a third sensor and a fourth sensor for detecting liquid level information in the filter device, and the filter device includes a reaction liquid port and a retentate liquid port, wherein the third sensor is disposed at the reaction liquid port, and the fourth sensor is disposed at the retentate liquid port.
However Shevitz a similar filter for alternating flow filtration of living cell solutions, wherein gas positive or negative pressure applied to a liquid chamber causes liquid to flow in and out of the filter for tangential flow filtration, wherein the filter device comprises a filter portion 17 and a storage portion 7/8, wherein the filter portion is disposed close to the bottom end of the filter device, the storage portion is disposed close to the top end of the filter device, the storage portion is configured as a hollow chamber to form the liquid chamber 7, and the storage portion is in direct communication with the filter portion (as they are attached/integral), wherein the liquid chamber comprises a single chamber that directly interfaces with the top end of the filter device (as they are attached/integral), see Fig. 1, 2, Abstract, [0114], and discloses this arrangement as an alternative to one where the liquid chamber is separate from the filter and connected by a conduit, see Fig. 16.
Therefore, before the effective filing date, it would have been prima facie obvious to one of ordinary skill in the art to modify the filter system of Pralong in view of Yeh, Doi and Yang by integrating the liquid chamber with the filter device by incorporating it into the filter as disclosed by Shevitz because this is a known alternative arrangement to a separate liquid chamber connected by a conduit. While it is noted that in Pralong the liquid chamber is connected to the bottom of the filter, as Shevitz shows the liquid chamber which drives fluid flow is on the top, and supplying fluid to the top, it would have been obvious to arrange the filter so that the liquid chamber is incorporated into the top of the filter, i.e. inverting the filter of Pralong because this is a known alternative arrangement of such filters, and because there is no criticality placed on the orientation of the filter of Pralong.
Pralong discloses wherein the biological filtration system further comprises in the liquid chamber, which in the combination of Pralong in view of Yeh, Doi, Yang and Shevitz is integral with the top of the filter, a third sensor LSH 26, and a further sensor LSL 25 for detecting liquid level information in the top and bottom of the liquid chamber (i.e. thus part of the filter device), Fig. 1, [0069]. Wherein the top of the liquid chamber may be considered a reaction liquid port and the bottom of the liquid chamber a retentate liquid port, thus the third sensor is disposed at the reaction liquid port, and the fourth sensor is disposed at the retentate liquid port.
Regarding Claim 28 Pralong in view of Yeh, Doi, Yang and Shevitz discloses the biological filtration system of claim 3, where in claim 3 the liquid chamber comprising a plurality of liquid chambers is recited in the alternative, and thus not required. The further limitations to claim 28 are thus directed to an optional component and are themselves optional and need not be further addressed. However, please note that the lines L1 and L4 of Yang in the figures discloses an arrangement as claimed.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Pralong in view of Yeh, Doi and Yang further in view of US 20190185803 A1 (hereinafter “Grant”).
Regarding Claim 8 Pralong in view of Yeh, Doi and Yang discloses the biological filtration system of claim 2, but does not disclose wherein the biological filtration system comprises a fourth conduit, a fifth conduit and a sixth conduit, wherein one of the top end and the bottom end of the filter device is connected to the chamber through the fourth conduit, the other one of the top end and the bottom end of the filter device is connected to the bioreactor through the fifth conduit, the chamber is connected to the bioreactor through the sixth conduit, the positive pressure pump is used to drive the solution in the chamber to flow to the bioreactor through the filter device, and the negative pressure pump is used to drive the solution in the bioreactor to flow to the chamber; or the positive pressure pump is used to drive the solution in the chamber to flow to the bioreactor, and the negative pressure pump is used to drive the solution in the bioreactor to flow to the chamber through the filter device.
However Grant discloses a similar system for filtering cell cultures from a bioreactor using alternating tangential flow, wherein a liquid chamber 120 is attached to a positive/negative pressure pump to push fluid in and out of a filter, wherein the system comprises a fourth conduit 153 or 253, a fifth conduit 151 and a sixth conduit 152, wherein one of the top end and the bottom end of the filter device 140 is connected to the chamber 120 or 220 through the fourth conduit, the other one of the top end and the bottom end of the filter device 140 is connected to the bioreactor through the fifth conduit, the chamber 120 or 220 is connected to the bioreactor through the sixth conduit (Fig. 4, [0047]-[0050]).
Therefore, before the effective filing date, it would have been prima facie obvious to one of ordinary skill in the art to modify the filter system of Pralong in view of Yeh, Doi and Yang by using a fourth conduit, a fifth conduit and a sixth conduit to connect the liquid chamber, filter and bioreactor such that the bottom end of the filter device is connected to the liquid chamber through the fourth conduit, the top end of the filter device 140 is connected to the bioreactor through the fifth conduit, the liquid chamber is connected to the bioreactor through the sixth conduit as disclosed by Grant because this is disclosed as an alternative flow arrangement for the connection of the liquid chamber, filter and bioreactor, to a single pipe connecting the liquid chamber to the filter and another connecting the filter to the bioreactor (Grant Fig. 1 and Pralong Fig. 1), and would thus have been obvious to substitute the flow arrangement of Grant for the flow arrangement disclosed by Pralong to obtain the predictable result of a successful filtration system.
Thus in combination, the positive pressure pump is used to drive the solution in the chamber to flow to the bioreactor through the filter device, and the negative pressure pump is used to drive the solution in the bioreactor to flow to the chamber; or the positive pressure pump is used to drive the solution in the chamber to flow to the bioreactor, and the negative pressure pump is used to drive the solution in the bioreactor to flow to the chamber through the filter device.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Pralong in view of Yeh, Doi, Yang and Shevitz further in view of US 20150247114 A1 (hereinafter “Gebauer”).
Regarding Claim 7 Pralong in view of Yeh, Doi, Yang and Shevitz discloses the biological filtration system of claim 2, but does not disclose wherein the biological filtration system comprises a second conduit and a third conduit, wherein the bottom end of the filter device is connected to the bioreactor through the second conduit and the third conduit, the second conduit is disposed with a first one-way valve, so that the solution in the filter device flows to the bioreactor in one direction, and the third conduit is disposed with a second one-way valve, so that the solution in the bioreactor flows to the filter device in one direction.
However Gebauer discloses a similar the biological filtration system wherein two conduits (i.e. a second conduit and a third conduit) are used to transfer fluid back and forth between a filter and bioreactor, wherein the filter device is fluidly connected to the bioreactor through the second conduit 9 and the third conduit 8, the second conduit is disposed with a first one-way valve 9, so that the solution in the filter device flows to the bioreactor in one direction, and the third conduit is disposed with a second one-way valve 8, so that the solution in the bioreactor flows to the filter device in one direction; (Fig. 1, [0020]-[0023]).
Therefore, before the effective filing date, it would have been prima facie obvious to one of ordinary skill in the art to modify the filter system of Pralong in view of Yeh, Doi, Yang and Shevitz by fluidly connecting the bottom of the filter device and the bioreactor through a second conduit and the third conduit, where the second conduit is disposed with a first one-way valve, so that the solution in the filter device flows to the bioreactor in one direction, and the third conduit is disposed with a second one-way valve, so that the solution in the bioreactor flows to the filter device in one direction as disclosed by Gebauer because this involves the simple substitution of known arrangements of conduits used for controlling flow between a bioreactor and a filter to provide tangential flow perfusion to obtain the predictable result of forming a successful filter system.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Pralong in view of Yeh, Doi and Yang further in view of US 2014/0377739 A1 (hereinafter “Welch”).
Regarding Claim 17 Pralong in view of Yeh, Doi and Yang discloses the biological filtration system of claim 1, but does not disclose wherein the biological filtration system further comprises a pressure relief bypass, wherein the pressure relief bypass is disposed on a flow path between the liquid chamber and the positive pressure pump and/or the negative pressure pump for releasing gas pressure in the biological filtration system.
However Welch discloses similar methods and apparatus are disclosed for cell culture and cell recovery, wherein a gas source 6038 is used to supply gas to media 6020 in vessel 6000 and a pressure relief valve 6056 (i.e. bypass) is included on the gas source line 6052 in order to minimize pressure buildup in the device 6000 [0067].
Therefore, before the effective filing date, it would have been prima facie obvious to one of ordinary skill in the art to modify the filter system of Pralong in view of Yeh, Doi and Yang by including pressure relief valve (i.e. bypass) on the gas source line between the liquid chamber and the gas source as disclosed by Welch in order to minimize pressure buildup in the system.
The combination thus results in a pressure relief bypass, wherein the pressure relief bypass is disposed on a flow path between the liquid chamber and the positive pressure pump for releasing gas pressure in the biological filtration system as claimed.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Pralong in view of Yeh, Doi and Yang further in view of US 20210269477 A1 (hereinafter “Konstantinov”).
Regarding Claim 18 Pralong in view of Yeh, Doi and Yang discloses the biological filtration system of claim 1, wherein the filter device is disposed with a penetrating liquid port 10, and the biological filtration system further comprises permeate exit (arrow to “Permeate” after item 12) to be recovered or harvested and a flow controlling device (pump 12), wherein the penetrating liquid port is connected to the permeate exit, the flow controlling device is disposed between the permeate exit and the filter device, and is used to control a flow rate of the solution in the filter device to the permeate exit, Pralong Fig. 1, [0062].
The permeate exit is not specifically disclosed to comprise a collection container.
However Konstantinov discloses a similar system for filtering cell cultures from a bioreactor, wherein the permeate/filtrate is collected into a holding tank 10, Fig. 1, [0067]-[0068].
Therefore, before the effective filing date, it would have been prima facie obvious to one of ordinary skill in the art to modify the filter system of Pralong in view of Yeh, Doi and Yang by including a holding tank for collecting permeate from the filter as disclosed by Konstantinov in order to collect the permeate for harvesting or recovery.
Claim 33 is rejected under 35 U.S.C. 103 as being unpatentable over Pralong in view of Yeh, Doi and Yang further in view of WO 2020/152509 A1 (hereinafter “Bartake”).
Regarding Claim 33 Pralong in view of Yeh, Doi and Yang discloses the biological filtration system of claim 20, but does not disclose wherein the processor is further configured to: monitor a pressure signal in the biological filtration system; compare the pressure signal with a preset pressure threshold to determine whether there is a blockage in the biological filtration system; and if there is a blockage, send an alarm message.
However Bartake discloses a similar system for biological filtration (Abstract, [0010]), which uses a control system with a pressure sensor (i.e. a process configured to monitor a pressure signal in the biological filtration system) in the filter system to determine if a filter is clogged, and raising an alarm upon clogging [0082].
Therefore, before the effective filing date, it would have been prima facie obvious to one of ordinary skill in the art to modify the filter system of Pralong in view of Yeh, Doi and Yang by configuring the processor to monitor a pressure signal in the biological filtration system; to determine whether there is a blockage in the biological filtration system; and if there is a blockage, send an alarm message as disclosed by Bartake in order to alert an operator to resolve the cog.
While it is not specifically disclosed that the signal from the pressure sensor is compared to a preset pressure threshold in order to determine there is a clog; this would have been the most obvious way to use pressure sensor signal to determine a clog, i.e. due to too little or too much pressure in a fluid line, given no further direction by Bartake.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 1-3, 6-11, 16-18, 24 and 28-30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1-18, 20 and 22 of copending Application No. copending Application No. 18/602016 in view of Doi and Yang.
The claims 1-12, 20 and 22 of Application ‘016 disclose the same biological filtration system except for the following limitations:
Claims 1 and 24: Application ‘016 does not disclose a negative pressure buffer chamber, wherein the negative pressure buffer chamber is disposed on a flow path between the negative pressure pump and the liquid chamber; the negative pressure buffer chamber is configured to control a rising height of the solution in the liquid chamber, and when the negative pressure buffer chamber is working, the flow path between the negative pressure buffer chamber and the negative pressure pump is in a non-conducting state.
However, Yang discloses a similar system using alternating positive and negative pressure applied to vessels (adsorption towers) which uses a vacuum pump P1 and vacuum buffer tank V2 with associated control valve H1, where the vacuum pump is connected with the vessels through a vacuum pipeline, and the vacuum pipeline is connected with the vacuum buffer tank through a branch pipe i.e. with the vacuum buffer tank disposed on a flow path between the vacuum pump and the vessels (Abstract, Claims, pg. 2 para. starting “According to the efficiency curve…”, Figures).
Therefore, before the effective filing date, it would have been prima facie obvious to one of ordinary skill in the art to modify the filter system of Application ‘016 by including the vacuum buffer tank disposed on a flow path between the vacuum/negative pressure pump and the vessel (i.e. liquid chamber) and a control valve on a flow path between the vacuum/negative pressure pump and the vacuum buffer tank/NPBC as disclosed by Yang because this a known arrangement which allows the vacuum pump and vacuum buffer tank to quickly provide vacuum to the vessels and the utilization efficiency of the vacuum pump is higher, the power consumption of equipment is small, and more energy is saved (pg. 2 para. starting “According to the efficiency curve…”). Thus resulting in a negative pressure buffer chamber, wherein the negative pressure buffer chamber is disposed on a flow path between the negative pressure pump and the liquid chamber
Wherein the vacuum/negative pressure is used in Application ‘016 (and thus the combined invention) to control a rising height of the solution in the liquid chamber and thus the negative pressure buffer chamber is configured to control a rising height of the solution in the liquid chamber.
With regard to the limitation “when the negative pressure buffer chamber is working, the flow path between the negative pressure buffer chamber and the negative pressure pump is in a non-conducting state” this is a functional limitation. Claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function (see MPEP 2114), and thus the prior art need only disclose structure capable of achieving the recited function(s) to read on the functional limitations. These functional limitations do not further define over the prior art because the structure disclosed by Application ‘016 would be capable of the noted functional limitation(s), i.e. even though the specific functions are not disclosed, because the vacuum pump may be shut off and valve H1 provided for the vacuum buffer tank/NPBC may be closed, either of which will allow the flow path between the negative pressure buffer chamber and the negative pressure pump to be in a non-conducting state. Thus the arrangement claimed is one of a finite number of possible arrangements of the system, and would be functionally able to be operated as claimed.
Claim 28 Application ‘016 discloses the biological filtration system of claim 3, where in claim 3 the liquid chamber comprising a plurality of liquid chambers is recited in the alternative, and thus not required. The further limitations to claim 28 are thus directed to an optional component and are themselves optional and need not be further addressed. However, please note that the lines L1 and L4 of Yang in the figures discloses an arrangement as claimed.
Claim 29 Application ‘016 discloses the biological filtration system of claim 1, and with regard to the limitation “wherein the flow path between the negative pressure buffer chamber and the liquid chamber is in the non-conductive state, a flow path between the negative pressure buffer chamber and the negative pressure pump is in a conductive state, the negative pressure pump provides a negative pressure to the negative pressure buffer chamber” this is a functional limitation. Claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function (see MPEP 2114), and thus the prior art need only disclose structure capable of achieving the recited function(s) to read on the functional limitations. These functional limitations do not further define over the prior art because the structure disclosed by Application ‘016 would be capable of the noted functional limitation(s), i.e. even though the specific functions are not disclosed, because Yang discloses a control valve H1 in the flow path between the negative pressure source (i.e. the NPBC in the combined invention) and the liquid chamber which is obviously/necessarily either open or closed and thus may be in the non-conductive state, and wherein a flow path between the negative pressure source/NPBC may obviously be in a conductive state, and the negative pressure pump (i.e. inherently, and as discussed supra) provides a negative pressure to the negative pressure buffer chamber. Thus the arrangement claimed is one of a finite number of possible arrangements of the system, and would be functionally able to be operated as claimed.
Claim 30 Application ‘016 discloses the biological filtration system of claim 29, but does not disclose wherein a second pressure regulating device is disposed between the negative pressure pump and the negative pressure buffer chamber, and the second pressure regulating device is used to control a suction gas pressure of the negative pressure pump to the negative pressure buffer chamber; when a pressure in the negative pressure buffer chamber reaches a preset pressure value, the second pressure regulating device is switched to a closed state, so that the flow path between the negative pressure pump and the negative pressure buffer chamber is in the non-conductive state, and the negative pressure pump stops working, and the negative pressure buffer chamber forms a negative pressure corresponding to the preset pressure value.
However, Yang discloses vacuumizing the vacuum buffer tank to reduce the pressure to a setpoint (i.e. 45-50 kPa), and discloses opening and closing valve H1 (a second pressure regulating device disposed between the negative pressure pump and the negative pressure buffer chamber) to control the pressure of the negative pressure pump to the negative pressure buffer chamber and thus in the vacuum buffer tank/NPBC and closing it depending on the pressure of the NPBC and what parts of the cycle the system is in (last paragraph of Example 5).
Therefore, before the effective filing date, it would have been prima facie obvious to one of ordinary skill in the art to modify the filter system of Application ‘016 by including the valve H1 (i.e. disposed between the negative pressure pump and the negative pressure buffer chamber) to control the pressure to and in the NPBC and closing it when the NPBC has reached desired pressure (i.e. thereby when a pressure in the negative pressure buffer chamber reaches a preset pressure value, the second pressure regulating device is switched to a closed state, so that the flow path between the negative pressure pump and the negative pressure buffer chamber is in the non-conductive state) and the negative pressure buffer chamber forms a negative pressure corresponding to the preset pressure value as disclosed by Yang because this allows the pressure in the NPBC to be controlled to a specific value to provide the liquid chamber with appropriate desired pressure.
It is not disclosed that the negative pressure pump stops working when the preset pressure value is reached, however this would have been obvious since the pressure has been reached an non more vacuum is needed.
Claims 20 and 32 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1-18, 20 and 22 of copending Application No. copending Application No. 18/602016 in view of Doi, Yang and Pralong.
Claim 20: Application ‘016 does not disclose the processor is configured to: obtain a first time of triggering the first liquid level signal; obtain a second time of triggering the second liquid level signal; and adjust, based on a time difference between the first time and the second time, a flow rate of the solution.
However Pralong discloses measure the time spent by the medium between the LSL level and the LSH level, to determine if the membrane has clogged, and adjusting the medium flow rate in order to unclog the membrane [0075]. While it is not specifically disclosed how the controller measures the time spent by the medium between the LSL level and the LSH level, this would obviously or inherently be done by obtaining a first time of triggering the first liquid level signal, obtaining a second time of triggering the second liquid level signal and calculating a time difference between the first time and the second time, as there are no other means given to calculate this time.
Therefore, before the effective filing date, it would have been prima facie obvious to one of ordinary skill in the art to modify the filter system of Application ‘016 in view of Doi and Yang by configuring the processor to: obtain a first time of triggering the first liquid level signal; obtain a second time of triggering the second liquid level signal; and adjust, based on a time difference between the first time and the second time, a flow rate of the solution, because this a known means of responding to a clogged filter.
Claim 32 Application ‘016 in view of Doi, Yang and Pralong discloses the biological filtration system of claim 20, wherein, as discussed above in the rejection of claim 20, Pralong discloses the processor identifying variations in speed and then controlling the positive and negative pressure cycle to adjust the medium flow rate [0075], where it would have been obvious to do so based on a time difference between the first time and the second time.
Application ‘016 in view of Doi, Yang and Pralong does not disclose the processor is configured to compare the time difference with a preset time difference; if the time difference is less than the preset time difference, control a pressure regulating device of the biological filtration system to reduce pressure to reduce the flow rate of the solution; and if the time difference is greater than the preset time difference, control the pressure regulating device to increase the pressure to increase the flow rate of the solution.
However, as it is disclosed that variation in flow speed, and thus time difference between the first time and the second time, are used to determine clogging ([0075], supra), it would have been obvious to compare the time difference to a preset value, in order to determine if the value is out of range, i.e. of normal or desired flow speed, and thus time.
With regard to what to do after determining that the value is out of range, it is disclosed that the media flow rate may be adjusted by control of the positive and negative pressure [0075], but does not disclose whether that is to increase or decrease the flow speed. However, there are a finite number of solutions, i.e. the time difference must necessarily be above or below the preset value, and the speed adjustment must necessarily be either to increase or decrease speed, where obviously/necessarily in order to increase speed pressure would be increased or decreased and to decrease pressure would be would be increased or decreased. As no specific direction is given, it would have been obvious to try any of those possible, finite options. Thus it would have been obvious to configure to processor to compare the time difference with a preset time difference; if the time difference is less than the preset time difference, control a pressure regulating device of the biological filtration system to reduce pressure to reduce the flow rate of the solution; and if the time difference is greater than the preset time difference, control the pressure regulating device to increase the pressure to increase the flow rate of the solution as claimed.
Claim 33 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1-18, 20 and 22 of copending Application No. copending Application No. 18/602016 in view of Doi, Yang, Pralong and Bartake.
Claim 33: Application ‘016 Application ‘016 in view of Doi, Yang and Pralong discloses the biological filtration system of claim 20, but does not disclose wherein the processor is further configured to: monitor a pressure signal in the biological filtration system; compare the pressure signal with a preset pressure threshold to determine whether there is a blockage in the biological filtration system; and if there is a blockage, send an alarm message.
However Bartake discloses a similar system for biological filtration (Abstract, [0010]), which uses a control system with a pressure sensor (i.e. a process configured to monitor a pressure signal in the biological filtration system) in the filter system to determine if a filter is clogged, and raising an alarm upon clogging [0082].
Therefore, before the effective filing date, it would have been prima facie obvious to one of ordinary skill in the art to modify the filter system of Application ‘016 in view of Doi, Yang and Pralong by configuring the processor to monitor a pressure signal in the biological filtration system; to determine whether there is a blockage in the biological filtration system; and if there is a blockage, send an alarm message as disclosed by Bartake in order to alert an operator to resolve the cog.
While it is not specifically disclosed that the signal from the pressure sensor is compared to a preset pressure threshold in order to determine there is a clog; this would have been the most obvious way to use pressure sensor signal to determine a clog, i.e. due to too little or too much pressure in a fluid line, given no further direction by Bartake.
This is a provisional nonstatutory double patenting rejection.
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter: The prior art does not disclose or make obvious the limitations of claim 31. While the prior art discloses it is obvious to use the negative pressure buffer chamber to help control the negative pressure, which in turn controls the liquid level, it is not disclose a process configured to calculate a first negative pressure value that the negative pressure buffer chamber needs to provide to the liquid chamber to reach the maximum height.
Claim 31 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, as well as resolving the 112(b) rejection of claim 1, from which claim 31 ultimately depends.
Response to Amendment
The previous 35 U.S.C. 112(b) rejections of claim 8, 12 and 14 are withdrawn in view of the Applicants’ arguments and amendments.
Response to Arguments
Applicant's arguments filed 11/12/2025 have been fully considered and they are persuasive with regard to the previous combination of references as they would apply to the amended claims, but they are now moot because they are directed in their entirety to grounds of rejection which are no longer cited in the current action and the new limitations of the amended claims which had not been previously addressed. See the updated rejection above citing a new combination of references to address the amended claims.
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.
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/ERIC J MCCULLOUGH/ Examiner, Art Unit 1773
/BENJAMIN L LEBRON/ Supervisory Patent Examiner, Art Unit 1773