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 .
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 1-7, and 9-10 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 1 recites the limitation "the internal volume of said vessel tank" in line 8. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mietzner et al. (US 2017/0369828A1), in view of Solomons et al. (US 4256839).
Regarding claim 1, Mietzner teaches fluid vessel for use in a bioprocessing system, the fluid vessel comprising:
a vessel tank (refer fig. 11) having a top, a sidewall, and a plurality of inlet ports (refer CIP ports 1122) defined in the sidewall;
a sump assembly (refer section 1102) having an upper end fluidly coupled below the vessel tank section (1104), the sump portion having a sidewall with an inlet port (refer 1122 provided in sump portion) defined therein, said sump portion having an internal volume for holding fluid smaller than the internal volume of said vessel tank (refer fig. 7, fig. 8 disclosing volumes of sump portion being smaller than rest of the vessel), and a first impeller (1114) configured to stir fluid within said vessel tank, and a second impeller (1110) configured to stir fluid in said sump portion.
Mietzner does not teach that the first and second impeller are separately controllable.
Solomon teaches a reactor system comprising a vessel having two individually controllable impellers (refer fig. 3 disclosing impeller 6 and 10), wherein one impeller (6) is provided in upper portion of the vessel and another impeller (10) is provided at a lower portion of the vessel. Solomon discloses that impeller 6 is driven by a shaft 7 from any suitable type of power source 8 through gearing 9, the gearing 9 includes means whereby the speed of rotation of the impeller 6 may be independently varied (refer column 3 – lines 31-35), and the impeller (10) is driven by shaft 11 from power source 12 through gearing 13, the gearing 13 includes means for infinitely varying speed of rotation of impeller 10 (refer Column 3 – Lines 50-54). Solomon also discloses that one impeller mainly achieving circulation of the biomass or ferment within the fermenter and the other impeller mainly creating a fine dispersion of the oxygen (refer Column 2 – Lines 39-42).
It would have been obvious to one of ordinary skill in the art before the effective filing date of invention to modify the vessel of Mietzner to include a separately controllable second impeller in the sump vessel as to provide independent control of impeller to satisfy its desired function as taught by Solomon. Regarding claim 2, modified Mietzner teaches limitation of claim 1 as set forth above. Mietzer teaches (refer fig. 11) that the first and second inlet ports are defined in a sidewall of the vessel tank, the second inlet port (1122 in section 1104) being lower than the first inlet port (1122 in section 1106). The limitation “said first inlet port to deliver feed stream into said vessel tank at a lower height than delivered through said first inlet port” is reciting intended use/function of the inlet ports without imparting additional structure. "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).
Regarding claim 3, modified Mietzner teaches limitation of claim 1 as set forth above. Mietzner further teaches that the vessel can be multi-use, single-use, disposable, or non-disposable and can be formed of any suitable material including metal alloys such as stainless steel (e.g., 316 L or any other suitable stainless steel) and Inconel, plastics, and/or glass (refer [0083]). Selection of a known material would have been an obvious matter of choice to one of ordinary skill in the art.
Regarding claim 4, modified Mietzner teaches limitation of claim 1 as set forth above. The limitation “sump vessel is formed of a disposable material” does not recite any limiting definition of “disposable material” or any particular material and therefore does not differentiate the vessel tank or sump of Mietzner. Mietzner also teaches that the vessel can be multi-use, single-use, disposable, or non-disposable and can be formed of any suitable material including metal alloys such as stainless steel (e.g., 316 L or any other suitable stainless steel) and Inconel, plastics, and/or glass (refer [0083]).
Regarding claims 5 and 6, modified Mietzner teaches limitation of claim 1 as set forth above. Mietzner further teaches that at least one ridge (1124 in sump 1102) extends inwardly from a sidewall of said sump vessel, and that the ridge 1124 is configured to provide suitable mixing conditions without causing undue stress on the bioreactor inoculum (Refer [0056]). Mietzner also discloses a stirrer 1110 which would inherently create a vortex.
Regarding claim 7, modified Mietzner teaches limitation of claim 1 as set forth above. In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. Selecting volume/size of the vessel tank and the sump would have been an obvious matter of design choice to one of ordinary skill in the art based on desired amount of liquid to be processed in the vessel. With regards to the volume comparison between the sump and the vessel, in embodiments of fig. 7 and 8, Mietzner discloses sump which is less than 1/10th of the vessel volume.
Claim(s) 9-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mietzner et al. (US 2017/0369828A1), in view of Solomons et al. (US 4256839) as applied to claim 1 above, and further in view of Alibek et al. (US 2022/0364126A1).
Regarding claims 9-10, modified Mietzner teaches limitations of claim 1 as set forth above. Mietzner further teaches a liquid inlet (refer 1122 in upper portion of the vessel). Mietzner also teaches that the vessel can have a variety of ports, probes, spargers and other components such as at least one of an agitator shaft, an agitator, such as an impeller, a sparger, a probe port, a fill port, a condenser, a vent filter, a foam breaker plate, a sample port, a level probe, and a load cell (refer [0052]). Mietzner does not disclose that the port is a spray ball, however, use of spray balls is well known in the art as indicated by Alibek (refer [0027]).
It would have been obvious to one of ordinary skill in the art to use a known shape/structure of spray nozzle, such as spray ball, in the vessel of Bell. The Supreme Court in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007) identified a number of rationales to support a conclusion of obviousness. Examples of rationales that may support a conclusion of obviousness that applies in this instance include: Simple substitution of one known element for another to obtain predictable results (in this instant use of spray ball in place of spray nozzle), and Use of known technique to improve similar devices (methods, or products) in the same way (use of known spray ball in the vessel of Mietzer). With regard to the limitation “said spray ball is configured to spray buffer solution into said vessel tank directed to the interior of the sidewall of said vessel tank” is reciting a function of spray ball without reciting additional structure. "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original).
Claim(s) 11-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mietzner et al. (US 2017/0369828A1), in view of Solomons et al. (US 4256839) and Gyure (US 2009/0130704A1).
Regarding claim 11, Mietzner teaches fluid vessel for use in a bioprocessing system, the fluid vessel comprising:
a vessel tank (refer fig. 11) having a top, a sidewall, and a plurality of inlet ports (refer CIP ports 1122) defined in the sidewall;
a sump assembly (refer section 1102) having an upper end fluidly coupled below the vessel tank section (1104), the sump portion having a sidewall with an inlet port (refer 1122 provided in sump portion) defined therein, said sump portion having an internal volume for holding fluid smaller than the internal volume of said vessel tank (refer fig. 7, fig. 8 disclosing volumes of sump portion being smaller than rest of the vessel), and a first impeller (1114) configured to stir fluid within said vessel tank, and a second impeller (1110) configured to stir fluid in said sump portion.
Mietzner also teaches that the vessel can be multi-use, single-use, disposable, or non-disposable and can be formed of any suitable material including metal alloys such as stainless steel (e.g., 316 L or any other suitable stainless steel) and Inconel, plastics, and/or glass (refer [0083]).
Mietzner does not teach that the first and second impeller are separately controllable.
Solomon teaches a reactor system comprising a vessel having two individually controllable impellers (refer fig. 3 disclosing impeller 6 and 10), wherein one impeller (6) is provided in upper portion of the vessel and another impeller (10) is provided at a lower portion of the vessel. Solomon discloses that impeller 6 is driven by a shaft 7 from any suitable type of power source 8 through gearing 9, the gearing 9 includes means whereby the speed of rotation of the impeller 6 may be independently varied (refer column 3 – lines 31-35), and the impeller (10) is driven by shaft 11 from power source 12 through gearing 13, the gearing 13 includes means for infinitely varying speed of rotation of impeller 10 (refer Column 3 – Lines 50-54). Solomon also discloses that one impeller mainly achieving circulation of the biomass or ferment within the fermenter and the other impeller mainly creating a fine dispersion of the oxygen (refer Column 2 – Lines 39-42).
It would have been obvious to one of ordinary skill in the art before the effective filing date of invention to modify the vessel of Mietzner to include a separately controllable second impeller in the sump vessel as to provide independent control of impeller to satisfy its desired function as taught by Solomon.
Mietzner also teaches that the vessel can have a variety of ports, probes, spargers and other components such as at least one of an agitator shaft, an agitator, such as an impeller, a sparger, a probe port, a fill port, a condenser, a vent filter, a foam breaker plate, a sample port, a level probe, and a load cell (refer [0052]). Mietzer discloses a port (1122) that extends from a top of the vessel into vessel tank. Mietzner does not disclose that port is a spray ball.
Gyure teaches a fluid vessel comprising a vessel tank (105); and a spray ball (147) extending from a top of the fluid vessel into the vessel tank (refer fig. 1A). It would have been obvious to one of ordinary skill in the art to use a known shape/structure of spray nozzle, such as spray ball, in the vessel of Bell. The Supreme Court in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007) identified a number of rationales to support a conclusion of obviousness. Examples of rationales that may support a conclusion of obviousness that applies in this instance include: Simple substitution of one known element for another to obtain predictable results (in this instant use of spray ball in place of spray nozzle), and Use of known technique to improve similar devices (methods, or products) in the same way (use of known spray ball in the vessel of Mietzer).
The limitation “formed of a disposable material” does not recite any limiting definition of “disposable material” or any particular material and therefore does not differentiate from the spray ball of Gyure.
Regarding claim 12, modified Mietzner teaches limitations of claim 11 as set forth above. “wherein said spray ball is formed of an irradiatable sterilizable material” does not recite any specific material. The terms “irradiatable” means capable of being exposed to radiation, and “sterilizable” means capable of being sterilized which are inherently present for the bioreactor of Gyure.
Regarding claim 13, modified Mietzner teaches limitations of claim 11 as set forth above. Gyure indicates that the spray ball (147) includes a hollow stem having a plurality of perforations therethrough (refer fig. 1C). The limitation “configured to direct material through said hollow stem towards the interior of the sidewall of said vessel tank” is reciting a function of spray ball without reciting additional structure. "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original).
Regarding claim 14, modified Mietzner teaches limitations of claim 11 as set forth above. The limitation “said spray ball is configured to spray buffer solution into said vessel tank directed to the interior of the sidewall of said vessel tank to return materials stuck on the interior of the sidewall of said vessel tank to fluid contained within said vessel tank” is reciting a function of spray ball without reciting additional structure. "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original).
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mietzner et al. (US 2017/0369828A1), in view of Solomons et al. (US 4256839) and Gyure (US 2009/0130704A1) as applied to claim 11 above, and further in view of Jaques et al. (US 2017/0349874).
Regarding claim 15, modified Mietzner teaches limitations of claim 11 as set forth above. Mietzner further teaches that the vessel can be multi-use, single-use, disposable, or non-disposable and can be formed of any suitable material including metal alloys such as stainless steel (e.g., 316 L or any other suitable stainless steel) and Inconel, plastics, and/or glass (refer [0083]).
Modified Mietzner does not teach that the vessel tank is formed of a flexible polymeric material.
Jaques teaches a single use bioreactor comprising a vessel tank made from a flexible polymeric material (refer [0008]).
The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945). It would have been an obvious matter of choice to one of ordinary skill in the art to select a known material, such as flexible polymer as disclosed by Jaques, for the vessel tank of Gyure. See also In re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960) (selection of a known plastic to make a container of a type made of plastics prior to the invention was held to be obvious).
Claim(s) 16-17 and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mietzner et al. (US 2017/0369828A1), in view of Solomons et al. (US 4256839), Bell et al. (US 20130005014A1), and Nakai et al. (US 2019/0322975A1).
Regarding claims 16 and 17, Mietzner teaches fluid vessel for use in a bioprocessing system, the fluid vessel comprising:
a vessel tank (refer fig. 11) having a top, a sidewall, and a plurality of inlet ports (refer CIP ports 1122) defined in the sidewall;
a sump assembly (refer section 1102) having an upper end fluidly coupled below the vessel tank section (1104), the sump portion having a sidewall with an inlet port (refer 1122 provided in sump portion) defined therein, said sump portion having an internal volume for holding fluid smaller than the internal volume of said vessel tank (refer fig. 7, fig. 8 disclosing volumes of sump portion being smaller than rest of the vessel), and a first impeller (1114) configured to stir fluid within said vessel tank, and a second impeller (1110) configured to stir fluid in said sump portion.
Mietzner does not teach that the first and second impeller are separately controllable.
Solomon teaches a reactor system comprising a vessel having two individually controllable impellers (refer fig. 3 disclosing impeller 6 and 10), wherein one impeller (6) is provided in upper portion of the vessel and another impeller (10) is provided at a lower portion of the vessel. Solomon discloses that impeller 6 is driven by a shaft 7 from any suitable type of power source 8 through gearing 9, the gearing 9 includes means whereby the speed of rotation of the impeller 6 may be independently varied (refer column 3 – lines 31-35), and the impeller (10) is driven by shaft 11 from power source 12 through gearing 13, the gearing 13 includes means for infinitely varying speed of rotation of impeller 10 (refer Column 3 – Lines 50-54). Solomon also discloses that one impeller mainly achieving circulation of the biomass or ferment within the fermenter and the other impeller mainly creating a fine dispersion of the oxygen (refer Column 2 – Lines 39-42).
It would have been obvious to one of ordinary skill in the art before the effective filing date of invention to modify the vessel of Mietzner to include a separately controllable second impeller in the sump vessel as to provide independent control of impeller to satisfy its desired function as taught by Solomon. Modified Mietzner does not teach that the system comprises a processing system, wherein the processing system comprises a filter unit; and a fluid line assembly fluidly coupling said vessel tank and said sump assembly with said processing system, and comprising: a vessel outlet feed line fluidly coupling said fluid vessel with said processing system; a first return line fluidly coupled with the sidewall of said vessel tank at a first height along said fluid vessel to return fluid processed in said processing system to said vessel tank; a second return line fluidly coupled with the sidewall of said vessel tank at a second height along said fluid vessel lower than the first height to return fluid processed in said processing system to said vessel tank; and a sump return line fluidly coupled with the sidewall of said sump assembly below said first return line and said second return line.
Bell teaches a system for processing a fluid solution, said system comprising: a fluid vessel comprising a vessel tank (refer tank in fig. 1) having a first volume, and a sump assembly (400) having a second volume smaller than the first volume (fig. 1 is indicative of sump being smaller than the tank) and fluidly coupled to a bottom of said vessel tank (refer fig. 1 indicating 400 being coupled to bottom of the tank);
a processing system (600) comprising a filter (refer [0046]); and
a fluid line assembly fluidly coupling said vessel tank and said sump assembly with said processing system (refer conduits 420, 460, 610), and comprising:
a vessel outlet feed line (420) fluidly coupling said fluid vessel with said processing system;
a first return line (610) fluidly coupled with a sidewall of said vessel tank at a first height along said fluid vessel to return fluid processed in said processing system to said vessel tank; and
a sump return line (510) fluidly coupled with said sump assembly.
It would have been obvious to one of ordinary skill in the art before the effective filing date of invention to modify the system of modified Mietzner to include a processing system comprising a filter; and a fluid line assembly fluidly coupling said vessel tank and said sump assembly with said processing system, and comprising: a vessel outlet feed line fluidly coupling said fluid vessel with said processing system; a first return line fluidly coupled with a sidewall of said vessel tank at a first height along said fluid vessel to return fluid processed in said processing system to said vessel tank; and a sump return line fluidly coupled with said sump assembly for recirculation of content of the vessel and enable filtering of a portion of the content of the vessel as taught by Bell.
Modified Mietzner does not teach a second return line fluidly coupled with a sidewall of said vessel tank at a second height along said fluid vessel lower than the first height to return fluid processed in said processing system to said vessel tank, and that the sump return line is located below said first return line and said second return line.
Nakai discloses a system (100) for processing a solution, the system comprises a vessel (10), a processing system (20), and a fluid line assembly (refer conduits connecting different components of the system), wherein the fluid line assembly comprises a first return line coupling the vessel to return fluid processed from the processing system (refer conduit 52 returning retentate of processing system 20), a second return line connecting the vessel to the processing system (Refer conduits 53 and 54 returning to the vessel from the processing system 20 via filer 30).
Selecting to provide additional conduits to connect the processing system to the vessel would have been obvious matter of design choice to one of ordinary skill in the art to mix the content of the vessel with retentate/permeate of the processing system to achieve desired concentration in the vessel. Particular placements of the conduits connecting to the vessel would have been obvious to one of ordinary skill in the art because shifting/changing position of inlets/outlets would have been an obvious matter of design choice and would not have modified operation of the device. 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).
Regarding claim 21, modified Mietzner teaches limitation of claim 16 as set forth above. Mietzner further teaches that the vessel can be multi-use, single-use, disposable, or non-disposable and can be formed of any suitable material including metal alloys such as stainless steel (e.g., 316 L or any other suitable stainless steel) and Inconel, plastics, and/or glass (refer [0083]). Selection of a known material for the vessel and the sump would have been an obvious matter of choice to one of ordinary skill in the art.
Claim(s) 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mietzner et al. (US 2017/0369828A1), in view of Solomons et al. (US 4256839), Bell et al. (US 20130005014A1), and Nakai et al. (US 2019/0322975A1) as applied to claim 16 above, and further in view of Gyure (US 2009/0130704A1).
Regarding claim 18, modified Mietzner teaches limitation of claim 16 as set forth above. Mietzner also teaches that the vessel can have a variety of ports, probes, spargers and other components such as at least one of an agitator shaft, an agitator, such as an impeller, a sparger, a probe port, a fill port, a condenser, a vent filter, a foam breaker plate, a sample port, a level probe, and a load cell (refer [0052]). Mietzer discloses a port (1122) that extends from a top of the vessel into vessel tank. Mietzner does not disclose that port is a spray ball.
Gyure teaches a fluid vessel comprising a vessel tank (105); and a spray ball (147) extending from a top of the fluid vessel into the vessel tank (refer fig. 1A). It would have been obvious to one of ordinary skill in the art to use a known shape/structure of spray nozzle, such as spray ball, in the vessel of Bell. The Supreme Court in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007) identified a number of rationales to support a conclusion of obviousness. Examples of rationales that may support a conclusion of obviousness that applies in this instance include: Simple substitution of one known element for another to obtain predictable results (in this instant use of spray ball in place of spray nozzle), and Use of known technique to improve similar devices (methods, or products) in the same way (use of known spray ball in the vessel of Mietzer).
Regarding claim 19, modified Mietzner teaches limitation of claim 18 as set forth above. Gyure teaches that the spray ball is connected to a feed line (146, Refer fig. 1A). The limitation “for buffer solution and configured to spray buffer solution towards the interior of the vessel tank sidewall” is reciting material being worked up by the spray ball and a function of spray ball without reciting additional structure. "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original).
Regarding claim 20, “wherein said spray ball is formed of a disposable irradiatable sterilizable material” does not recite any specific material. The term “disposable” means subject to or available for disposal, and “irradiatable” means capable of being exposed to radiation which are inherently present for the spray ball of modified Bell.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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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/PRANAV N PATEL/ Primary Examiner, Art Unit 1777