DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
The objections to the specification are withdrawn.
The objection to the drawings is withdrawn.
Claim objections and the rejection under 35 U.S.C. 112(b) (see page 5 of Office action dated July 9th, 2025) did not appear to be addressed in the response and they are repeated below.
Applicant's arguments filed December 9th, 2025 have been fully considered but they are not persuasive.
The Applicant argues that Dumschat teaches away from external filters (Remarks, page 19) because (paraphrasing) it adds cost and the filter in the cartridge (swap body 12) is more cost effective and easily replaceable (Remarks, pages 21-22). However, “the nature of the teaching is highly relevant and must be weighed in substance”. For example, “a known or obvious composition does not become patentable simply because it has been described as somewhat inferior to some other product for the same use”. See In re Gurley, 27 F.3d 551, 553, 31 USPQ2d 1130, 1132 (Fed. Cir. 1994). In this case, Dumschat appears to state that an external filter may still be used with a filter internal to the cartridge by stating “Even if a second fine filter is installed in the stationary production plant” (Dumschat, para. [0009]). Further, rather than teaching away, Dumschat indicates the internal filter is a trade-off by stating that it requires at least some additional effort: “The routine replacement of the fine filter represents only a very small additional effort” (para. [0010]). Thus, from the disclosure of Dumschat alone, the person of ordinary skill would recognize that the selection of an external or internal filter is a trade-off as the external filter could presumably be used through multiple cycles as Dumschat discloses it could be used through dozens of cycles when combined with an internal filter (Dumschat, para. [0009]) compared to the internal filter which is changed out or cleaned each time the cartridge is filled for a new cycle (Dumschat, para. [0034]).
Moreover, 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). In this case, Labarge et al. teaches an external filter (filter 210) in a dissolution system (Abstract) having a cartridge (container 202 with flexible portion 102). The use of external filters is known in the art and modifying Dumschat by merely changing the position of filters from an internal to an external filter would achieve the predictable result of filtering solids from a fluid stream and the argument is not persuasive.
In response to applicant's argument that (paraphrasing) there is no motivation to use an external filter and the Examiner's conclusion of obviousness is based upon improper hindsight reasoning in regard to the external filter (the combination of Dumschat and Labarge et al., Remarks, page 22), it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). The examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). As discussed above, the use of external filters is known and the Applicant has not pointed out any specific information in the rejection that could only be gleaned from their own disclosure, and thus there is no evidence of hindsight reasoning.
The Applicant argues that using a single pump in Dumschat would change the principle of operation (Remarks, page 19), would require substantial redesign, and Dumschat would be rendered inoperable with only one pump (Remarks, pages 20-21) and it would not be obvious to reduce the number of pumps. The Examiner respectfully disagrees and contends that Dumschat again indicates a trade-off as related to the number of pumps and the construction of the cartridge. As noted by the Applicant (Remarks, page 21), Dumschat indicates that elimination of the pump would require additional design effort, presumably structural reinforcements, to prevent the possibility of bursting (Dumschat, para. [0014]). Thus, the person of ordinary skill would recognize that the pump 70 could be eliminated and the system could maintain reliability by reinforcing the cartridge and/or connections to the cartridge and the principle of operation would be unchanged in that the device would still circulate fluid to dissolve solute in the cartridge.
Moreover, Jonsson et al. teaches the use of a single pump (pump 31) for driving the flow through a circulation loop of a dissolution system (for dissolving salt in solid form to produce a saturated solution, Abstract) having a biocontainer (tank 20) and cartridges (salt containers 2 and 3). Thus, the use of a single pump for driving flow in a circulation loop having a biocontainer and cartridges is known and as discussed above, Dumschat could be modified to utilize a single pump such as by reinforcing the cartridge allowing for elimination of a pump as a trade-off. Thus, the argument is not persuasive.
The Applicant argues that Labarge et al. presents a single use mixing system and Jonsson et al. provides “methods and apparatus for preparing solutions for medical purposes” and each reference addresses distinct problems with unique solutions such that a method effective in one context would not be suitable in the other (Remarks, page 20). The Examiner respectfully contends that Larbarge et al. and Jonsson et al. are both dissolution systems applicable to the system of Dumschat. Labarge et al. is a dissolution system (Labarge et al., col. 22, line 26) and is relied upon to teach an external filter and as discussed above, modifying Dumschat with an external filter would produce predictable results. Likewise, Jonsson et al., like Dumschat, teaches a dissolution system (Abstract) having a biocontainer (tank 20) and cartridges (salt containers 2 and 3) on a circulation loop and Jonsson et al. is relied upon to teach a single pump which is adapted to receive the supply of fluid from the container outlet of the biocontainer and to discharge a flow of fluid therefrom in a circulation direction to the container inlet (Fig. 2). As discussed above, using a single pump in Dumschat would also produce predictable results (circulating a flow of fluid for dissolving a solute). Thus, the argument is not persuasive.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1 recites “directed from the cartridge inlet through storage chamber” in line 13 and it’s recommended to change this to “directed from the cartridge inlet through the storage chamber”.
Claim 18 recites “a bypass line” in line 2, but the bypass line is already recited in claim 17 from which it depends. This should be changed to “the bypass line”.
Claim 19 recites “the speed of the pump” which lacks antecedent basis and should be changed to “a speed of the pump”.
Appropriate correction is required.
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.
Claim 14 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, 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.
Claim 14 recites “a downstream filter disposed upstream of the buffer cartridge relative to the circulation direction between the buffer cartridge and the biocontainer” in line 6 and it is unclear how the downstream filter is upstream of the buffer cartridge. In view of Applicant’s amendments to the specification, this limitation is presumed to mean “a downstream filter disposed downstream of the buffer cartridge relative to the circulation direction between the buffer cartridge and the biocontainer”.
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 (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1 and 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over Dumschat (previously attached translation of DE202014105204) in view of Labarge et al. (US 11407968) and Jonsson et al. (US 5972223).
Regarding claim 1, Dumschat discloses a dissolution system (“dissolving dry concentrate 24”, Fig. 1, Abstract) as shown below:
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Dumschat discloses the system comprises: a biocontainer (container 14, para. [0029]), the biocontainer defining a container inlet (inlet 52), a container outlet (outlet 50), and a storage volume (shown above), the container inlet and outlet in communication with the storage volume (Fig. 1), and the storage volume is configured to hold a supply of fluid (liquid, para. [0029]); a pump (pump 40), the pump in fluid communication with the storage volume of the biocontainer (Fig. 1), the pump adapted to receive the supply of fluid from the container outlet of the biocontainer and to discharge a flow of fluid therefrom in a circulation direction to the container inlet (the pump discharges, in a circulation direction, toward the container inlet); a cartridge (container 20), the cartridge defining a cartridge inlet (shown above, liquid enters at opening 26, para. [0027]), a cartridge outlet (shown above), and a storage chamber (shown above), the cartridge inlet and outlet in communication with the storage chamber (Fig. 1), the storage chamber configured to hold an amount of solute (dry concentrate 24) for dissolution into the supply of fluid (para. [0035]), the storage chamber in fluid communication with the pump via the cartridge inlet to receive the flow of fluid therefrom (Fig. 1), the cartridge inlet, the storage chamber, and the cartridge outlet configured such that the flow of fluid is directed from the cartridge inlet through storage chamber and out the cartridge outlet to flow past the amount of solute in the storage chamber (shown above, annotated arrows indicate flow direction), the cartridge outlet in fluid communication with the container inlet (Fig. 1); an upstream filter (filter 30), the upstream filter in fluid communication with the biocontainer and the cartridge (Fig. 1); a downstream filter (outlet filter 60), the downstream filter in fluid communication with the cartridge and the biocontainer; a dissolution line (annotated above), the dissolution line fluidly coupling the biocontainer (container 14), the pump (pump 40), the cartridge (container 20), the upstream filter (filter 30), and the downstream filter (filter 60) in a circulation loop (as indicated with arrows above).
Dumschat discloses the filters are along the line within the cartridge rather than external to the cartridge.
However, Labarge et al. teaches a dissolution system (Col. 22, line 26) having a cartridge (comprising rigid container 202 with flexible portion 102) with a storage chamber configured to hold an amount of solute (dry media, Col. 19, line 37) and Labarge et al. teaches a filter external to the cartridge (filter 210, Fig. 2).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the teachings of Dumschat wherein the filters are located in the line external to the cartridge such that the upstream filter is interposed between the container outlet of the biocontainer and the cartridge inlet of the cartridge upstream of the cartridge relative to the circulation direction and the downstream filter is interposed between the cartridge outlet of the cartridge and the container inlet of the biocontainer downstream of the cartridge relative to the circulation direction.
The person of ordinary skill in the art would have been motivated to place filters external to the cartridge such as to facilitate changing filters or the person of ordinary skill would have found it obvious to rearrange the location of the filter from inside the cartridge to outside the cartridge and thereby achieve the predictable result of filtering the liquid entering and exiting the cartridge. See In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950) and In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975).
Dumschat does not disclose the pump is a single pump which provides flow from the container outlet of the biocontainer to the container inlet. Rather, Dumschat discloses two pumps along this circuit (pumps 40 and 70).
However, Jonsson et al. teaches a dissolution system (for dissolving salt in solid form to produce a saturated solution, Abstract) having a biocontainer (tank 20) and cartridges (salt containers 2 and 3) with a dissolution line (Fig. 2, line connecting tank 20, cartridges 2 or 3, pump 31, and other equipment) and Jonsson et al. teaches the pump (pump 31) is adapted to receive the supply of fluid from the container outlet of the biocontainer and to discharge a flow of fluid therefrom in a circulation direction to the container inlet (Fig. 2) as shown below:
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Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the teachings of Dumschat by using one pump along the circulation direction (instead of two, Dumschat, pump 40 and 70) such that the pump is in fluid communication with the storage volume of the biocontainer, the pump adapted to receive the supply of fluid from the container outlet of the biocontainer and to discharge a flow of fluid therefrom in a circulation direction to the container inlet.
The person of ordinary skill in the art would have been motivated to reduce the number of pumps in order to reduce the number of components necessary to operate the device and otherwise achieve the predictable result of providing movement of fluids.
Regarding claims 3-4, Dumschat does not teach a mixer.
However, Labarge et al. who is relied upon to teach a filter external to the cartridge as discussed in claim 1 above further teaches a prefilter section (section 806, Fig. 8) which may comprise a filter and a static mixer (Col. 29, lines 35-50).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the teachings of Dumschat wherein the system comprises a static mixer, the static mixer in fluid communication with the cartridge (Labarge et al., container 808) and the downstream filter (Labarge et al., filter 816), such that the mixer is interposed between the cartridge and the downstream filter (Fig. 8).
The person of ordinary skill in the art would have been motivated to include a static mixer in order to improve mixing and dissolution.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Dumschat (previously attached translation of DE202014105204) in view of Labarge et al. (US 11407968) and Jonsson et al. (US 5972223) as applied to claim 1 above and in further view of Eble et al. (US 20180221798) and Kuennen et al. (US 20090045106).
Regarding claim 2, Dumschat does not disclose a prefilter.
However, Labarge et al. who is relied upon to teach a filter external to the cartridge as discussed in claim 1 above further teaches a prefilter (prefilter element 806, Fig. 8).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the teachings of Dumschat wherein the system further comprises a pre-filter, the pre-filter in fluid communication with the cartridge and the downstream filter such that the pre-filter is interposed between the cartridge and the downstream filter.
The person of ordinary skill in the art would have been motivated to use a prefilter in order to extend the life of filter and improve filtration efficiency.
The combined teachings of the above-cited references do not explicitly disclose the prefilter has a larger volume than the filter.
However, Eble et al. discloses a system which is analogous art at least because it is reasonably pertinent to the problem of selecting filters (liquid filter and prefilter, Abstract) and Eble et al. discloses a filter (filter 28, Fig. 2) and prefilter (prefilter 30, Fig. 3) and Eble et al. discloses the filter has a first interior volume and the pre-filter having a second interior volume, the second interior volume being greater than the first interior volume (Fig. 2).
Further, Kuennen et al. discloses a system which is analogous art at least because it is reasonably pertinent to the problem of selecting filters (water filter, Abstract) or Kuennen et al. further teaches that a prefilter has a larger interior volume than the filter (Fig. 3B, the prefilter 20 surrounding the filter 18/16).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined teachings of the above-cited references by substituting one filter configuration (Labarge et al., prefilter 806 and filter 816, Fig. 8) for another known configuration (Eble et al., Fig. 2 or Kuennen et al., Fig. 3B) wherein the downstream filter has a first interior volume and the pre-filter has a second interior volume, the second interior volume being greater than the first interior volume.
The person of ordinary skill in the art would have found it obvious to substitute one liquid filter configuration (Labarge et al., prefilter 806 and filter 816, Fig. 8) for another known configuration (Eble et al., Fig. 2 or Kuennen et al., Fig. 3B) and thereby achieve the predictable result of filtering liquid. See KSR International Co. v. Teleflex Inc. (KSR), 550 U.S. 398, 82 USPQ2d 1385 (2007).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Dumschat (previously attached translation of DE202014105204) in view of Labarge et al. (US 11407968) and Jonsson et al. (US 5972223) as applied to claim 1 above and in further view of Turner et al. (US 20240307835), Saito et al. (US 20190224633) and Fletcher et al. (US 20210362106A1).
Regarding claim 5, Dumschat discloses a valve to selectively control the flow of fluid through the cartridge (valve 41, para. [0030]), but does not disclose the flow is controlled by the valve based upon a pressure.
However, Saito et al. discloses a system for generating a solution (dissolving a gas in liquid, para. [0041]) wherein a cartridge is used (module 2) and Saito et al. further teaches using a rate detection unit to selectively control the flow of fluid from the cartridge using a valve (valve 9) and based upon a detection in the line downstream of the cartridge (detection unit 8, Fig. 1, controls valve 9, para. [0040]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the teachings of Dumschat wherein the valve is adapted to selectively control the flow of fluid through the cartridge based upon a flow rate in the dissolution line downstream of the cartridge between the cartridge and the biocontainer.
The person of ordinary skill in the art would have been motivated to use a detection means to control the flow rate through the cartridge in order improve mixing.
The above-cited references do not expressly teach a pressure sensor to control the flow rate, but Fletcher et al. teaches a dissolution system having a cartridge (mixing chamber 12 with dry powdered media, para. [0027], including dry buffer powder, para. [0007]) and Fletcher et al. suggests using pressure sensors (para. [0041]) to control valves (para. [0034]) including valves which could serve to bypass the cartridge (using valves 52, 62, 70, and 78, the cartridge could be bypassed via filter tube 58 flowing to filter 16, Fig. 1A) and Turner et al. teaches a system for preparing a solution (para. [0002]) and Turner et al. teaches that a flow rate may be determined by using a pressure sensor (para. [0057]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the teachings of the above-cited references by controlling the valve with a pressure sensor wherein the valve (Dumschat, valve 41, Saito et al, valve 9) is adapted to selectively control the flow of fluid through the cartridge based upon a pressure (which is indicative of a flow rate, Turner et al., para. [0057]) in the dissolution line downstream of the cartridge between the cartridge and the biocontainer.
The person of ordinary skill in the art would have found it obvious to utilize a pressure sensor to achieve the predictable result of indicating a flow rate (Turner et al., para. [0057]) for controlling the valve and flow rate in order to improve dissolution/mixing.
Claims 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Dumschat (previously attached translation of DE202014105204) in view of Labarge et al. (US 11407968), Jonsson et al. (US 5972223), Turner et al. (US 20240307835), Saito et al. (US 20190224633) and Fletcher et al. (US 20210362106A1) as applied to claim 5 above and in further view of Lorenzen (US 3626972) and Levesque et al. (US 5928608).
Regarding claim 6, Dumschat discloses the device includes an upstream junction (at valve 41) the upstream junction being disposed upstream of the cartridge relative to the circulation direction (Dumschat, Fig. 1) and Dumschat discloses a line (connecting valve 41 to biocontainer inlet 54) which could act as a bypass (having a three-way valve 41) of the cartridge (container 20), but Dumschat does not explicitly disclose the line is used as a bypass.
However, Saito et al. who is relied upon to teach controlling the valve with a sensor as discussed for claim 5 above further discloses wherein the line includes an upstream junction and a downstream junction, the upstream junction being disposed upstream of the cartridge relative to the circulation direction and the downstream junction being disposed downstream of the cartridge relative to the circulation direction, and a bypass line, the bypass line being in fluid communication with the dissolution line at the upstream junction and the downstream junction such that the bypass line is in parallel relationship with the cartridge as shown below:
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Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the teachings of Dumschat to include wherein the dissolution line includes an upstream junction (Saito et al., branch 13) and a downstream junction (Saito et al., joint 14), the upstream junction being disposed upstream of the cartridge relative to the circulation direction and the downstream junction being disposed downstream of the cartridge relative to the circulation direction and the dissolution system further comprising: a bypass line (Saito et al., line 6), the bypass line being in fluid communication with the dissolution line at the upstream junction and the downstream junction such that the bypass line (Saito et al., line 6) is in parallel relationship with the cartridge.
The person of ordinary skill in the art would have been motivated to utilize a junction and bypass line in order to better control the flow of liquid to improve mixing and dissolution.
The combined teachings of the above cited references do not expressly disclose the junctions are located between the filters and cartridge.
However, Lorenzen teaches a dissolution system (dissolving soluble granules, Abstract) where an upstream filter is located between a bypass junction (shown below) and the inlet of the cartridge and Levesque et al. also teaches a dissolution system (chlorinator, Abstract ) where a downstream junction is located between the cartridge outlet of the cartridge (the chlorinator 36) and a downstream filter (filter 6, Fig. 2) as shown below:
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Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the teachings of Dumschat wherein the upstream junction is located between the upstream filter and the cartridge inlet of the cartridge, and the downstream junction being disposed between the cartridge outlet of the cartridge and the downstream filter.
The person of ordinary skill in the art would have found it obvious to rearrange the location of filters such as by placing an upstream filter before a junction in order to remove debris before the stream passes through potential clog points such as bends, elbows, or the cartridge interior and to place a filter downstream of the cartridge in order to ensure the stream is well mixed prior to being filtered in order to prevent undissolved solids from arriving at the filter or it would have been otherwise obvious to change the location of the filters to the claimed location and achieve the predictable result of filtering the stream. See In re Japikse, supra and In re Kuhle, supra.
Regarding claim 7, Dumschat does not disclose a flow control system.
However, Saito et al. who is relied upon to teach controlling the valve with a sensor as discussed for claim 5 above further discloses a flow control system, the flow control system (control unit 10) configured to selectively control the flow of fluid through at least one of the dissolution line and the bypass line (Saito et al., both - because operating valve 9 will affect flow in both lines, see Fig. 1 and as shown above; for example: shutting valve 9 will cause more flow through the bypass line 6).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the teachings of Dumschat to include a flow control system, the flow control system configured to selectively control the flow of fluid through at least one of the dissolution line and the bypass line.
The person of ordinary skill in the art would have been motivated to include a flow control system in order to better control the flow of liquid to improve mixing and dissolution.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Dumschat (previously attached translation of DE202014105204) in view of Labarge et al. (US 11407968), Jonsson et al. (US 5972223), Turner et al. (US 20240307835), Saito et al. (US 20190224633), Fletcher et al. (US 20210362106A1), Lorenzen (US 3626972) and Levesque et al. (US 5928608) as applied to claim 7 above and in further view of Lage (US 3661364) and Harm et all. (US 4734198).
Regarding claim 8, Dumschat discloses wherein the pump comprises a dissolution pump (Dumschat, pump 40), but does not explicitly disclose the dissolution pump disposed in the dissolution line between the upstream junction and the cartridge inlet.
However, Lage discloses a mixing device (Abstract) where a mixing tank is fed with a pump (pump 2) and the pump is located downstream of a junction (confluence of pipe 11 and pipe 3) where the pump feeds the inlet of the mixing tank (via line 5, Fig. 1).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the teachings of Dumschat wherein the dissolution pump is disposed in the dissolution line between the upstream junction and the cartridge inlet.
The person of ordinary skill in the art would have found it obvious to rearrange the pump location to between a junction and inlet and thereby achieve the predictable result of pumping liquid to the cartridge. See In re Japikse, supra and In re Kuhle, supra.
The combined teachings of the above-cited references further disclose wherein the flow control system includes a bypass pump (Dumschat, pump 42) and a pressure sensor (Saito et al., detection unit 8, Fig. 1, where a pressure sensor is used for detecting a flow rate as taught by Turner et al., para. [0057]), the bypass pump disposed in the bypass line (Saito et al., line 6), and the pressure sensor disposed in the dissolution line between the cartridge outlet and the container inlet (Saito et al., downstream of the cartridge 2 outlet corresponding to between the cartridge outlet and the container inlet of Dumschat), the pressure sensor configured to generate a pressure signal (Saito et al., sent to control unit 10 for controlling valve 9) corresponding to a pressure sensed in the dissolution line by the pressure sensor.
The above cited references do not expressly discloses controlling a pump with a pressure signal.
However, Harm et al. discloses a dissolution system (solution from dry chemicals, Abstract) and Harm et al. further teaches controlling a pump with a pressure sensor (Col. 6, lines 38-41).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the teachings of Dumschat wherein at least one of the bypass pump and the dissolution pump are adapted to operate based upon the pressure signal.
The person of ordinary skill in the art would have been motivated to control pumps based on pressure signals in order to control the flow rate or to deenergize the pumps upon sensing a pressure level indicative of a problem (Harm et al., Col. 6, lines 23-28).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Dumschat (previously attached translation of DE202014105204) in view of Labarge et al. (US 11407968), Jonsson et al. (US 5972223), Turner et al. (US 20240307835), Saito et al. (US 20190224633), Fletcher et al. (US 20210362106A1), Lorenzen (US 3626972) and Levesque et al. (US 5928608) as applied to claim 7 above and in further view of Hildmann et al. (previously attached translation of DE 102017118718B3).
Regarding claim 9, Dumschat discloses wherein the pump (Dumschat, pump 40) is disposed in the dissolution line between the container outlet and the upstream junction (Dumschat, between outlet 50 and junction at valve 41).
Dumschat does not disclose a flow control system with a dissolution valve, a bypass valve and a pressure sensor.
However, Hildmann et al. teaches a dissolution system (for powdered or granular substance) having a cartridge (bag 3 containing the powder) and biocontainer (tank 6) as shown below:
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Hildmann et al. further teaches wherein the flow control system includes a dissolution valve (valve 1, Fig. 3, shown above), a bypass valve (valve 2, Fig. 3, shown above), and a pressure sensor (pressure sensor D1, para. [0095]) wherein the dissolution valve is disposed in the dissolution line between the upstream junction and the cartridge inlet, the bypass valve is disposed in the bypass line (Fig. 3, shown above).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the teachings of Dumschat wherein the flow control system includes a dissolution valve, a bypass valve and a pressure sensor wherein the dissolution valve is disposed in the dissolution line between the upstream junction and the cartridge inlet, the bypass valve disposed in the bypass line.
The person of ordinary skill in the art would have been motivated to use a pressure sensor, bypass valve, and dissolution valve to ensure the correct pressure is used within the cartridge (Hildmann, bag 3, para. [0095]).
Dumschat does not disclose and Hildmann et al. does not teach that the pressure sensor is between the cartridge outlet and container inlet.
However, Saito et al. teaches a sensor (detection unit 8) for controlling a valve (valve 9 using control unit 10, Fig. 1) where the sensor is located downstream of a cartridge (module 2, Fig. 1, a location corresponding to between the cartridge and container of Dumschat) and Fletcher et al. teaches a dissolution system having a cartridge (mixing chamber 12 with dry powdered media, para. [0027], including dry buffer powder, para. [0007]) and Fletcher et al. suggests using pressure sensors (para. [0041]) to control valves (para. [0034]) including valves which could serve to bypass the cartridge (using valves 52, 62, 70, and 78, the cartridge could be bypassed via filter tube 58 flowing to filter 16, Fig. 1A).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the teachings of Dumschat by arranging the pressure sensor in the dissolution line between the cartridge outlet and container inlet or to add a pressure sensor and control valve (Fletcher et al. suggests using pressure sensors to control valves, pars. [0041] and [0043], where Fletcher et al. teaches a cartridge inlet valve 52 and outlet valve 80) at both the inlet and outlet of the cartridge wherein a pressure sensor is also in the dissolution line between the cartridge outlet and container inlet.
The person of ordinary skill in the art would have found it obvious to rearrange the pressure sensor (Hildmann, sensor D1) to a location downstream of the cartridge (Saito et al., detection unit 8, Fig. 1) and thereby achieve the predictable result of indicating a pressure in the cartridge (Hildmann et al., correct pressure, para. [0095]) as both an inlet and outlet pressure would be indicative of a pressure within the cartridge where the pressure is maintained to facilitate dissolution. See In re Japikse, supra and In re Kuhle, supra. Otherwise, the person of ordinary skill in the art would have found it obvious to duplicate the pressure sensor (Hildmann, sensor D1) at an outlet of the cartridge and thereby achieve a higher level of flow control (as suggested by Fletcher et al., para. [0043]).
The combined teachings of the above-cited references further disclose the pressure sensor (Hildmann et al., sensor D1, Fletcher et al., pressure sensors, pars. [0041] and [0043], Saito et al., detection unit 8) is configured to generate a pressure signal corresponding to a pressure sensed in the dissolution line by the pressure sensor, and at least one of the dissolution valve (Hildmann, valve V1, Fletcher et al., inlet valve 52) and the bypass valve (Hildmann, valve V2) adapted to operate based upon the pressure signal.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Dumschat (previously attached translation of DE202014105204) in view of Labarge et al. (US 11407968), Jonsson et al. (US 5972223), Turner et al. (US 20240307835), Saito et al. (US 20190224633), Fletcher et al. (US 20210362106A1), Lorenzen (US 3626972), Levesque et al. (US 5928608) and Hildmann et al. (previously attached translation of DE 102017118718B3) as discussed for claim 9 above and in further view of Bouch (US 20190002314A1).
Regarding claim 10, Dumschat does not disclose a characteristic sensor.
However, Fletcher et al. who is relied upon to teach a pressure sensor as discussed for claim 9 above also teaches using a characteristic sensor (including pH sensor and conductivity sensors, para. [0041]) and insomuch as Fletcher et al. is silent as to the location of the sensor, the sensor would presumably be located in a line and Bouch teaches a dissolution system (chlorinator for dissolving solid chlorine, para. [0002]) and Bouch teaches the pH-sensor is located in a line (Fig. 2, sensor 58).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the teachings of Dumschat to include
a solution characteristic sensor, the solution characteristic sensor disposed in the dissolution line, the solution characteristic sensor configured to generate a characteristic signal corresponding to a value of a solution characteristic sensed (Fletcher et al., conductivity or pH, para. [0041], Bouch, para. [0031], Fig. 2) in the dissolution line by the solution characteristic sensor.
The person of ordinary skill in the art would have found it obvious to use characteristic sensors in order to monitor the progress of the dissolution (such as via a change in pH).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Dumschat (attached translation of DE202014105204) in view of Labarge et al. (US 11407968), Jonsson et al. (US 5972223), Turner et al. (US 20240307835), Saito et al. (US 20190224633), Fletcher et al. (US 20210362106A1), Lorenzen (US 3626972), Levesque et al. (US 5928608), Hildmann et al. (previously attached translation of DE 102017118718B3) and Bouch (US 20190002314A1) as applied to claim 10 above and in further view of Li et al. (US 20130109102).
Regarding claim 11, the combined teachings of the above-cited references for claim 10 above disclose wherein the solution characteristic sensor comprises a pH sensor (Fletcher, para. [0041], Bouch, pH-sensor 58, Fig. 2 ), and the characteristic signal comprises a pH signal.
Dumschat does not disclose a pH adjustment line.
However, Bouch who teaches a pH sensor in a line as discussed for claim 10 above further discloses a pH adjustment line (Fig. 2, from acid container 53) and a pH adjustment valve (valve 75, Fig. 2), the pH adjustment line in fluid communication with the dissolution line and adapted to deliver a supply of pH-adjusting fluid to the dissolution line (para. [0031]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the teachings of Dumschat to include a pH adjustment line and a pH adjustment valve, the pH adjustment line in fluid communication with the dissolution line and adapted to deliver a supply of pH-adjusting fluid to the dissolution line.
The person of ordinary skill in the art would have been motivated to include a pH adjustment line in order to adjust the pH (Jonsson et al., Col. 11, line 6, Bouch, para. [0020]).
The above cited references do not explicitly disclose the pH-adjusting valve is adapted to operate based on the pH signal, but rather a pump (Bouch, acid pump 52) is adapted to operate based on the pH-signal (Bouch, Fig. 2).
However, Li et al. discloses a system which is analogous art at least because it is reasonably pertinent to the problem of adjusting pH in a flow of liquid (Abstract) and Li et al. teaches a pH adjustment valve (valves 31a-c) operable to selectively occlude the pH adjustment line (the line they are connected to, Fig. 3) to interrupt the flow of the supply of pH-adjusting fluid (acid or base, Fig. 3), the pH adjustment valve adapted to operate based upon the pH signal (generated from pH sensor 26, para. [0013]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the teachings of the above-cited references for claim 10 by substituting a pump for regulating the pH-adjusting fluid using a sensor signal (Bouch, acid pump 52, Fig. 2) for a valve to regulate the flow of pH-adjusting fluid (Li et al., valves 31a-c) wherein the pH adjustment valve is operable to selectively occlude the pH adjustment line to interrupt the flow of the supply of pH-adjusting fluid to the dissolution line, the pH adjustment valve adapted to operate based upon the pH signal.
The person of ordinary skill in the art would have found it obvious to substitute one method of controlling the flow of pH-adjusting fluid (Bouch, pump 52) for another known method (Li et al., valves 31) and thereby achieve the predictable result of controlling the flow of pH-adjusting fluid to the circulation line. See KSR International Co. v. Teleflex Inc. (KSR), supra.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Dumschat (previously attached translation of DE202014105204) in view of Labarge et al. (US 11407968), Jonsson et al. (US 5972223), Turner et al. (US 20240307835), Saito et al. (US 20190224633), Fletcher et al. (US 20210362106A1), Lorenzen (US 3626972), Levesque et al. (US 5928608), Hildmann et al. (previously attached translation of DE 102017118718B3), Bouch (US 20190002314A1) and Li et al. (US 20130109102) as applied to claim 11 above and in further view of Wilds et al. (US 20220211888).
Regarding claim 12, the above-cited references for claim 11 do not explicitly disclose wherein the pH adjustment line is in fluid communication with a circulation line via a bypass line.
However, Wilds et al. discloses a system which is analogous art at least because it is reasonably pertinent to the problem of adjusting pH in a flow of liquid (para. [0033]) and Wilds et al. teaches a pH adjustment line is in fluid communication with a circulation line via a bypass line (Fig. 1, pH raising fluid 82 is delivered to a bypass line before being delivered to the circulation line) as shown below:
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Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the teachings of Dumschat wherein the pH adjustment line is in fluid communication with the dissolution line via the bypass line.
The person of ordinary skill in the art would have found it obvious to rearrange the location of the pH adjusting line to the bypass and thereby achieve the predictable result of delivering a pH-adjusting fluid. See In re Japikse, supra and In re Kuhle, supra.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Dumschat (previously attached translation of DE202014105204) in view of Labarge et al. (US 11407968), Saito et al. (US 20190224633), Lorenzen (US 3626972), Levesque et al. (US 5928608), Turner et al. (US 20240307835) and Fletcher et al. (US 20210362106A1).
Regarding claim 13, Dumschat discloses a dissolution system (system which dissolves dry concentrate, Abstract) comprising: a dissolution line (Fig. 1 and shown above for claim 1), the dissolution line fluidly coupling a biocontainer (container 14), a pump (pump 40), a cartridge (container 20), an upstream filter (filter 30), and a downstream filter (filter 60) in a circulation loop (annotated with arrows as shown above for claim 1), the biocontainer configured to hold a supply of fluid, the pump adapted to receive the supply of fluid from the biocontainer and to discharge a flow of fluid therefrom in a circulation direction; the cartridge configured to hold an amount of solute (dry concentrate, para. [0027]) for dissolution into the supply of fluid, the cartridge in fluid communication with the pump to receive the flow of fluid therefrom and to pass the flow of fluid therethrough (Fig. 1) the upstream filter in fluid communication with the biocontainer and the cartridge, the downstream filter in fluid communication with the cartridge and the biocontainer (Fig. 1, shown above for claim 1).
Dumschat discloses the filters are along the dissolution line within the cartridge rather than external to the cartridge.
However, Labarge et al. teaches a dissolution system (Col. 22, line 26) having a cartridge (comprising rigid container 202 with flexible portion 102) with a storage chamber configured to hold an amount of solute (dry media, Col. 19, line 37) and Labarge et al. teaches a filter external to the cartridge (filter 210, Fig. 2).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the teachings of Dumschat wherein the filters are located in the dissolution line external to the cartridge such that the upstream filter is interposed between the biocontainer and the cartridge upstream of the cartridge relative to the circulation direction and the downstream filter is interposed between the cartridge and the biocontainer downstream of the cartridge relative to the circulation direction.
The person of ordinary skill in the art would have been motivated to place filters external to the cartridge such as to facilitate changing filters or the person of ordinary skill would have found it obvious to rearrange the location of the filter from inside the cartridge to outside the cartridge and thereby achieve the predictable result of filtering the liquid entering and exiting the cartridge. See In re Japikse, supra and In re Kuhle, supra.
Dumschat discloses the dissolution line includes an upstream junction (at valve 41) the upstream junction being disposed upstream of the cartridge relative to the circulation direction (Dumschat, Fig. 1) and Dumschat discloses a line (connecting valve 41 to biocontainer inlet 54) which could act as a bypass (having a three-way valve 41) of the cartridge (container 20), but Dumschat does not explicitly disclose the line is used as a bypass.
However, Saito et al. discloses a system for generating a solution (dissolving a gas in liquid, para. [0041]) wherein a cartridge is used (module 2) and Saito et al. teaches wherein the line includes an upstream junction and a downstream junction, the upstream junction being disposed upstream of the cartridge relative to the circulation direction and the downstream junction being disposed downstream of the cartridge relative to the circulation direction, and a bypass line, the bypass line being in fluid communication with the dissolution line at the upstream junction and the downstream junction such that the bypass line is in parallel relationship with the cartridge (as shown above for claim 6).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the teachings of Dumschat to include wherein the dissolution line includes an upstream junction (Saito et al., branch 13) and a downstream junction (Saito et al., joint 14), the upstream junction being disposed upstream of the cartridge relative to the circulation direction and the downstream junction being disposed downstream of the cartridge relative to the circulation direction and the dissolution system further comprising: a bypass line (Saito et al., line 6), the bypass line being in fluid communication with the dissolution line at the upstream junction and the downstream junction such that the bypass line (Saito et al., line 6) is in parallel relationship with the cartridge.
The person of ordinary skill in the art would have been motivated to utilize a junction and bypass line in order to better control the flow of liquid to improve mixing and dissolution.
The combined teachings of the above cited references do not expressly disclose the junctions are located between the filters and cartridge.
However, Lorenzen teaches a dissolution system (dissolving soluble granules, Abstract) where an upstream filter is located between a bypass junction (shown above for claim 6) and the inlet of the cartridge and Levesque et al. also teaches a dissolution system (chlorinator, Abstract) where a downstream junction is located between the cartridge outlet of the cartridge (the chlorinator 36) and a downstream filter (filter 6, Fig. 2) as shown above for claim 6.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the teachings of Dumschat wherein the upstream junction is located between the upstream filter and the cartridge, and the downstream junction being disposed between the cartridge and the downstream filter.
The person of ordinary skill in the art would have found it obvious to rearrangement the location of filters such as by placing an upstream filter before a junction in order to remove debris before the stream passes through potential clog points such as bends, elbows, or the cartridge interior and to place a filter downstream of the cartridge in order to ensure the stream is well mixed prior to being filtered in order to prevent undissolved solids from arriving at the filter or it would have been otherwise obvious to change the location of the filters to the claimed location and achieve the predictable result of filtering the stream. See In re Japikse, supra and In re Kuhle, supra.
Dumschat does not expressly disclose a means for controlling the flow of fluid through the cartridge.
However, Saito et al. further teaches a means for controlling the flow of fluid using a rate detection unit (detection unit 8) to selectively control the flow of fluid through the cartridge using a valve (valve 9) and based upon a detection in the line downstream of the cartridge (detection unit 8, Fig. 1, controls valve 9, para. [0040]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the teachings of Dumschat to include a means for controlling the flow of fluid through the cartridge, the flow controlling means configured to selectively control the flow of fluid through at least one of the dissolution line and the bypass line (both, Saito et al., by controlling valve 9 the flow of fluid through a dissolution line 7 and bypass line 6 will be controlled in that when the valve closes, the flow through the bypass line 6 will increase and vice versa, Fig. 1).
The person of ordinary skill in the art would have been motivated to use means for controlling the flow such as a detection means with a valve to control the flow rate through the cartridge in order improve mixing.
Insomuch as the above-cited references do not expressly teach using pressure to control the flow rate; Fletcher et al. teaches a dissolution system having a cartridge (mixing chamber 12 with dry powdered media, para. [0027], including dry buffer powder, para. [0007]) and Fletcher et al. suggests using pressure sensors (para. [0041]) to control valves (para. [0034]) including valves which could serve to bypass the cartridge (using valves 52, 62, 70, and 78, the cartridge could be bypassed via filter tube 58 flowing to filter 16, Fig. 1A) and Turner et al. teaches a system for preparing a solution (para. [0002]) and Turner et al. teaches that a flow rate may be determined by using a pressure sensor (para. [0057]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the teachings of Dumschat wherein the flow is controlled based upon a pressure (indicative of a flow rate, Turner et al., para. [0057]) in the dissolution line downstream of the cartridge (Saito et al., detecting unit 8, Fig. 1) between the cartridge and the biocontainer.
The person of ordinary skill in the art would have found it obvious to utilize a pressure sensor to achieve the predictable result of indicating a flow rate (Turner et al., para. [0057]) for controlling the valve and flow rate in order to improve dissolution/mixing.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Labarge et al. (US 11407968) in view of Dumschat (previously attached translation of DE202014105204).
Regarding claim 14, Labarge et al. discloses a method of preparing a buffer solution (a liquid media, Col. 1, lines 15-17, which may include buffer: Col. 11, lines 32-32, Co. 23, lines 18-19, dry powdered media, Col. 15, lines 56-57 includes buffer, Col. 10, lines 24-27).
Labarge et al. discloses the method comprises fluidly coupling a buffer cartridge (comprising rigid container 202 with flexible portion 102) the buffer cartridge containing an amount of a buffer solute (Col. 10, lines 24-27) and entraining at least a portion of the buffer solute from the buffer cartridge into the flow of fluid (Col. 20, lines 3-14).
Labarge et al. does not disclose a circulation loop with a biocontainer and Labarge et al. does not expressly teach an upstream filter.
However, Dumschat discloses a dissolution system (“dissolving dry concentrate 24”, Fig. 1, Abstract) as shown above for claim 1 and Dumschat discloses fluidly coupling a cartridge (container 20) in a circulation loop (shown above for claim 1) formed by a dissolution line (annotated above for claim 1), the dissolution line fluidly coupling in the circulation loop, a biocontainer (container 14, Fig. 1), a pump (pump 40) adapted to discharge a flow of fluid therefrom in a circulation direction (Fig. 1, shown above for claim 1) and including an upstream filter (filter 30, Fig. 1).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the teachings of Labarge et al. wherein the method includes fluidly coupling a buffer cartridge (Labarge et al., rigid container 202 with flexible portion 102, Dumschat, container 20) in a circulation loop formed by a dissolution line (Dumschat, shown above for claim 1), the dissolution line fluidly coupled in the circulation loop to a biocontainer (Dumschat, container 14), a pump (Dumschat, pump 40) adapted to discharge a flow of fluid therefrom in a circulation direction (Dumschat, Fig. 1) , the buffer cartridge, an upstream filter (Dumschat, filter 30) disposed upstream of the buffer cartridge (Labarge et al., container 202) relative to the circulation direction (Dumschat, Fig. 1, annotated above for claim 1) between the biocontainer and the buffer cartridge, and a downstream filter (Labarge et al., filter 210) disposed upstream of the buffer cartridge (as best understood, downstream of the buffer cartridge, see rejection under 35 U.S.C. 112(b) above) relative to the circulation direction between the buffer cartridge and the biocontainer (Labarge et al., downstream of the buffer cartridge 202, Fig. 2, corresponding to between the buffer cartridge 20 and biocontainer 14 of Dumschat), the buffer cartridge containing an amount of a buffer solute (Dumschat, Col. 10, lines 24-27); and circulating a flow of fluid (Labarge et al., Fig. 9, step 904) through the circulation loop (Dumschat, shown above for claim 1) to entrain at least a portion of the buffer solute from the buffer cartridge into the flow of fluid.
The person of ordinary skill in the art would have been motivated to add an upstream filter and to utilize a circulation method in order to increase filtration of the solution (Dumschat, para. [0011], by circulating the solution through multiple filters which would improve filtration compared to the single filter and single pass through the filter of Labarge et al.) and achieve complete mixing (Dumschat, para. [0013]).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Labarge et al. (US 11407968) in view of Dumschat (previously attached translation of DE202014105204) as applied to claim 14 above and in further view of Wagner (attached non-patent literature entitled “Creating a USP 800 Compliant Cleanroom”).
Regarding claim 15, Labarge et al. discloses the buffer solute comprising a powder (Col. 2, line 21) and is sterilized (Col. 16, line 50), but does not explicitly disclose a buffer transfer room (as best understood, any room suitable for loading a cartridge).
However, Wagner teaches a buffer room is used for sterile processes (“cleanrooms where sterile compounding is performed”, Definition of Terms, page 2).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the teachings of Labarge et al. to include wherein before fluidly coupling the buffer cartridge in the circulation loop, filling the buffer cartridge with the amount of buffer solute in a buffer transfer room.
The person of ordinary skill in the art would have found it obvious to use a buffer transfer room as a suitable location for loading sterile powder (Labarge et al., Col. 16, line 50, Wagner, Page 2).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Labarge et al. (US 11407968) in view of Dumschat (previously attached translation of DE202014105204) as applied to claim 14 above and in further view of Saito et al. (US 20190224633), Turner et al. (US 20240307835) and Fletcher et al. (US 20210362106A1).
Regarding claim 16, Labarge et al. does not disclose controlling the flow of fluid through the buffer cartridge based upon a pressure.
However, Saito et al. discloses a system for generating a solution (dissolving a gas in liquid, para. [0041]) wherein a cartridge is used (module 2) and Saito et al. further teaches using a flow rate detection unit to selectively control the flow of fluid from the cartridge using a valve (valve 9) and based upon a flow rate detection in the line downstream of the cartridge (detection unit 8, Fig. 1, controls valve 9, para. [0040]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the teachings of Dumschat wherein circulating the flow of fluid through the circulation loop includes controlling the flow of fluid through the buffer cartridge based on a flow rate in the dissolution line downstream of the buffer cartridge between the buffer cartridge and the biocontainer.
The person of ordinary skill in the art would have been motivated to use a detection means to control the flow rate through the cartridge in order improve mixing.
Insomuch as the above-cited references do not expressly teach using pressure to control the flow rate; Fletcher et al. teaches a dissolution system having a cartridge (mixing chamber 12 with dry powdered media, para. [0027], including dry buffer powder, para. [0007]) and Fletcher et al. suggests using pressure sensors (para. [0041]) to control valves (para. [0034]) and Turner et al. teaches a system for preparing a solution (para. [0002]) and Turner et al. teaches that a flow rate may be determined by using a pressure sensor (para. [0057]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the teachings of Dumschat by controlling the flow of fluid through the buffer cartridge based upon a pressure.
The person of ordinary skill in the art would have found it obvious to utilize a pressure sensor such that controlling the flow is based upon a pressure to achieve the predictable result of indicating a flow rate (Turner et al., para. [0057]) for controlling the valve and flow rate in order to improve dissolution/mixing.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Labarge et al. (US 11407968) in view of Dumschat (previously attached translation of DE202014105204) as applied to claim 14 above and in further view of Saito et al. (US 20190224633), Lorenzen (US 3626972), and Levesque et al. (US 5928608).
Regarding claim 17, Labarge et al. does not disclose the dissolution line comprises upstream and downstream junctions and Labarge et al. does not teach diverting at least a portion of the flow of fluid from the dissolution line into a bypass line.
However, Saito et al. discloses a system for generating a solution (dissolving a gas in liquid, para. [0041]) wherein a cartridge is used (module 2) and Saito et al. further teaches wherein the line includes an upstream junction and a downstream junction, the upstream junction being disposed upstream of the cartridge relative to the circulation direction and the downstream junction being disposed downstream of the cartridge relative to the circulation direction, and a bypass line, the bypass line being in fluid communication with the dissolution line at the upstream junction and the downstream junction such that the bypass line is in parallel relationship with the cartridge as shown above for claim 6.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the teachings of Labarge et al. wherein the dissolution line includes an upstream junction and a downstream junction, the upstream junction being disposed upstream of the buffer cartridge relative to the circulation direction and the downstream junction being disposed downstream of the buffer cartridge relative to the circulation direction the method further comprising: diverting at least a portion of the flow of fluid from the dissolution line into a bypass line (Saito et al., line 6), the bypass line being in fluid communication with the dissolution line at the upstream junction and the downstream junction such that the bypass line is in parallel relationship with the buffer cartridge (Saito et al., Fig. 1 as shown above for claim 6).
The person of ordinary skill in the art would have been motivated to utilize a junction and bypass line in order to better control the flow of liquid to improve mixing and dissolution.
The combined teachings of the above cited references do not expressly disclose the junctions are located between the filters and the cartridge.
However, Lorenzen teaches a dissolution system (dissolving soluble granules, Abstract) where an upstream filter is located between a bypass junction and the inlet of the cartridge (shown above for claim 6) and Levesque et al. also teaches a dissolution system (chlorinator, Abstract ) where a downstream junction is located between the cartridge outlet of the cartridge (the chlorinator 36) and a downstream filter (filter 6, Fig. 2) as shown above for claim 6.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the teachings of Labarge et al. wherein the upstream junction is located between the upstream filter and the buffer cartridge, and the downstream junction being disposed between the buffer cartridge and the downstream filter.
The person of ordinary skill in the art would have found it obvious to rearrange the location of filters such as by placing an upstream filter before a junction in order to remove debris before the stream passes through potential clog points such as bends, elbows, or the cartridge interior and to place a filter downstream of the cartridge in order to ensure the stream is well mixed prior to being filtered in order to prevent undissolved solids from arriving at the filter or it would have been otherwise obvious to change the location of the filters to the claimed location and achieve the predictable result of filtering the stream. See In re Japikse, supra and In re Kuhle, supra.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Labarge et al. (US 11407968) in view of Dumschat (previously attached translation of DE202014105204) as applied to claim 14 above and in further view of Saito et al. (US 20190224633), Lorenzen (US 3626972), and Levesque et al. (US 5928608) as applied to claim 17 above and in further view of Turner et al. (US 20240307835) and Fletcher et al. (US 20210362106A1).
Regarding claim 18, the above cited references do not explicitly discloses wherein diverting at least a portion of the flow of fluid from the dissolution line into a bypass line includes adjusting the amount of the flow of fluid diverted into the bypass line based upon a pressure in the dissolution line downstream of the buffer cartridge between the buffer cartridge and the biocontainer.
However, Saito et al. further teaches using a flow rate detection unit (detection unit 8, Fig. 1, controls valve 9, para. [0040]) to selectively control the flow of fluid from the cartridge using a valve (valve 9) wherein controlling the valve (valve 9) would result in diverting at least a portion of the flow of fluid into a bypass line (Saito et al., line 6) which includes adjusting the amount of the flow of fluid diverted into the bypass line (Saito et al., manipulating valve 9 would alter the flow through the bypass line 6, such as increasing the flow when the valve 9 is closed) based upon a flow rate (flow rate detection unit 8) in the dissolution line (Saito et al., line 7, Fig. 1A) downstream of the buffer cartridge (Saito et al., module 2).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the teachings of Labarge et al. wherein diverting at least a portion of the flow of fluid from the dissolution line into a bypass line includes adjusting the amount of the flow of fluid diverted into the bypass line based upon a flow rate in the dissolution line downstream of the buffer cartridge between the buffer cartridge and the biocontainer.
The person of ordinary skill in the art would have been motivated to use a detection means to control the flow rate through the cartridge by diverting through a bypass line in order improve mixing.
Insomuch as the above-cited references do not expressly teach using pressure to control the flow rate and adjust the flow diverted through the bypass line; Fletcher et al. teaches a dissolution system having a cartridge (mixing chamber 12 with dry powdered media, para. [0027], including dry buffer powder, para. [0007]) and Fletcher et al. suggests using pressure sensors (para. [0041]) to control valves (para. [0043]) including valves which could serve to bypass the cartridge (using valves 52, 62, 70, and 78, the cartridge could be bypassed via filter tube 58 flowing to filter 16, Fig. 1A) and Turner et al. teaches a system for preparing a solution (para. [0002]) and Turner et al. teaches that a flow rate may be determined by using a pressure sensor (para. [0057]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the teachings of Labarge et al. wherein diverting at least a portion of the flow of fluid from the dissolution line into a bypass line includes adjusting the amount of the flow of fluid diverted into the bypass line based upon a pressure.
The person of ordinary skill in the art would have found it obvious to utilize a pressure sensor to achieve the predictable result of indicating a flow rate (Turner et al., para. [0057]) for controlling the valve and flow rate through the cartridge and bypass line in order to improve dissolution/mixing.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Labarge et al. (US 11407968) in view of Dumschat (previously attached translation of DE202014105204) as applied to claim 14 above and in further view of Saito et al. (US 20190224633), Lorenzen (US 3626972), Levesque et al. (US 5928608), Turner et al. (US 20240307835) and Fletcher et al. (US 20210362106A1) as applied to claim 18 above and in further view of Bluchel et al. (US 20200078507) and Wyeth et al. (US 20220409794).
Regarding claim 19, the above-cited references for claim 18 do not teach controlling pump speed with a pressure sensor.
However, Bluchel et al. discloses a device which is analogous art at least because it is reasonably pertinent to controlling flow in a circulation line (Fig. 2) and Bluchel et al. further teaches controlling flow by adjusting pump speed based upon a pressure (pump 30 coupled to pressure sensor 35, para. [0126]) and Wyeth et al. likewise discloses a device which is analogous art at least because it is reasonably pertinent to controlling flow in a fluid line (Fig. 5) or Wyeth et al. teaches controlling flow by adjusting pump speed based upon a pressure (para. [0069]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the teachings of Labarge et al. wherein adjusting the amount of the flow of fluid diverted into the bypass line based upon the pressure in the dissolution line downstream of the buffer cartridge between the buffer cartridge and the biocontainer includes adjusting the speed of the pump in the dissolution line in inverse relationship to the pressure (if pressure is too high pump speed is lowered and vice versa).
The person of ordinary skill in the art would have found it obvious to adjust flow by substituting one flow adjusting means (valve controlled by a pressure sensor, Fletcher et al., para. [0043], Saito flow rate detecting unit 8 in view of Turner et al., para. [0057]) for another flow adjusting means (pump controlled by a pressure sensor (Bluchel et al., para. [0126] or Wyeth et al., para. [0069]) and thereby achieve the predictable result of controlling the flow of fluid. See KSR International Co. v. Teleflex Inc. (KSR), supra.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Labarge et al. (US 11407968) in view of Dumschat (previously attached translation of DE202014105204) as applied to claim 14 above and in further view of Bouch (US 20190002314A1).
Regarding claim 20, the combined teachings of the above-cited references for claim 14 disclose entraining substantially all of the buffer solute in the buffer cartridge into the flow of fluid;
circulating the flow of fluid through the circulation loop to substantially dissolve the buffer solute to form a buffer solution (Dumschat, “dry concentrate is completely and homogeneously dissolved in the entire liquid volume “para. [0003]) and Labarge et al. discloses sensing, using a sensor, a pH value of the buffer solution (Col. 24, lines 20-21).
Labarge et al. does not explicitly disclose adjusting the pH of the buffer solution to a target pH range by introducing a pH adjustment supply into the buffer solution based upon the sensed pH value.
However, Bouch teaches a dissolution system (chlorinator for dissolving solid chlorine, para. [0002]) and Bouch teaches adjusting the pH of the solution to a target pH range (para. [0034]) by introducing a pH adjustment supply into the solution based upon the sensed pH value (Bouch, Fig. 2, using pH sensor 58 and acid pump 52).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the teachings of Labarge et al. wherein the method includes adjusting the pH of the buffer solution to a target pH range by introducing a pH adjustment supply into the buffer solution based upon the sensed pH value.
The person of ordinary skill in the art would have been motivated to include a pH-adjustment supply in order to adjust the pH of the solution.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Moore et al. (US 4548228) discloses a mixing tank with a bypass line (line 30) wherein the flow of mixture from the mixing tank is controlled using a control valve (valve 50) which opens and closes in response to differential pressure.
Castaneda et al. (US 20180100137) discloses using pressure transducers and controlling pump speed (para. [0052])
Jansson et al. (US 20240009365) discloses controlling the pump speed with a pressure sensor (para. [0073]).
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/P.M.M./Examiner, Art Unit 1774
/CLAIRE X WANG/Supervisory Patent Examiner, Art Unit 1774