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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Specification
The previous objection to the abstract of the disclosure is withdrawn in light of the amendments.
Many, but not all, of the previous objections to the specification of the disclosure are withdrawn in light of the amendments. Please see the remaining objections due to marks used in commerce below.
The disclosure is objected to because of the following informalities:
Please note that the following marks should be used for the terms:
Fortem™ (paragraph [00026]) (already present)
Bioclear™ 10 (paragraph [00026]) (already present)
Bioclear™ 11 (paragraph [00026]) (please amend)
GE Healthcare® Life Sciences (paragraph [00026]) (please amend)
Pluronic® (paragraph [00036]) (already present)
which are trade names or marks used in commerce. The terms have been noted in this application. The terms should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Appropriate correction is required.
Claim Objections
The previous claim objections are withdrawn in light of the amendments.
Claim Rejections - 35 USC § 112
The previous rejections under 35 U.S.C. § 112(b) are withdrawn in light of the amendments.
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 factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 9 and 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Strimple (US 20160289091) (previously cited) in view of Staheli (US 20110207218) (previously cited).
Regarding claim 9, Strimple discloses an apparatus for reducing foaming (Fig. 3, element 66 “foam intercept device”; paragraphs [0006] and [0034]), the apparatus being disposed within a system (Fig. 1, element 56 “seawater aeration basin”; paragraph [0027]) and including:
a body portion having an underside surface (Fig. 3, element 102 “float frame”; paragraph [0034]); and
an opening in the body portion (Fig. 3, element 104 “open base”; paragraph [0042]);
wherein the underside surface of the body portion (Fig. 3, element 102 “float frame”; paragraph [0034]) is configured to divert rising gas bubbles within a liquid towards the opening (Fig. 3, generated foam “GF” is diverted into element 104 “float frame”, and the foam intercept device’s adjustable float frame can be just below the surface of the effluent seawater, thereby drawing the foam under the surface of the seawater; paragraph [0043]).
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Strimple, Fig. 3
Strimple does not disclose:
a bioprocessing system, comprising:
a vessel;
a flexible bioprocessing bag positionable within the vessel, the flexible bioprocessing bag being configured to contain a volume of liquid.
Staheli discloses:
a bioprocessing system (Fig. 1, element 10 “system”), comprising:
a vessel (Fig. 1, element 30 “chamber”; paragraph [0025]);
a flexible bioprocessing bag (Fig. 1, element 12 “container”; paragraphs [0024] and [0028]) positionable within the vessel (Fig. 1, element 30 “chamber”; paragraph [0025]), the flexible bioprocessing bag being configured to contain a volume of liquid (paragraph [0022]).
In the analogous art of foam intercept systems, it would have been obvious to one skilled in the art before the effective filing date to modify the foam intercept system of Strimple with the bioreactor system of Staheli in order to help reduce foam levels within a flexible disposable bioreactor bag.
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Staheli, Figs. 1 and 2
Regarding the phrase “for reducing cell shear of cells within the liquid and/or for reducing foaming”, the limitation is phrased in the alternative. Because at least one of the limitations is rejected above, no further rejections are required at this time.
Regarding the limitation “for reducing cell shear of cells within the liquid and/or for reducing foaming” the manner of operating or intended use of a claimed apparatus does not patentably distinguish it from the prior art. MPEP § 2114(II). The device of modified Strimple would be fully capable of operating in this manner given the device of Strimple in view of the system of Staheli.
Regarding claim 13, Strimple discloses the underside surface (Fig. 3, element 104 “open base”; paragraph [0034]) is configured to facilitate coalescence of the gas bubbles (Fig. 3, the foam coalesces into Figs. 1 or 2, element 68 “draw pipe”).
Strimple does not disclose wherein: the underside surface has a plurality of grooves configured to facilitate coalescence of the gas bubbles.
However, the presence of a plurality of grooves is an obvious change in shape, as the configuration of the claimed shape is a matter of choice, absent persuasive evidence that the particular configuration is significant. MPEP § 2144.04(IV)(B). It would have been obvious to one skilled in the art before the effective filing date to modify the shape of the device of Strimple to include a plurality of grooves to increase the surface area of the device accessible to the gas bubbles in order to more effectively collect the foam at the top of the opening of Strimple’s device, depending on the shape of the bioreactor bag or the vessel.
Regarding claim 14, Strimple discloses wherein:
the apparatus (Fig. 3, element 66 “foam intercept device”) further includes a peripheral wall (Fig. 3, element 106 “one or more walls”; paragraph [0035]) extending upwardly from the body portion (Fig. 3, element 102 “float frame”; paragraph [0034]) and circumscribing the opening (Fig. 3, element 104 “open base”), the peripheral wall (Fig. 3, element 106 “one or more walls”; paragraph [0035]) defining an isolation chamber therein (Fig. 3, element 108 “open interior area”; paragraph [0035]);
wherein the liquid / gas interface (Fig. 3, element 86 “surface 86 of effluent seawater”; paragraph [0034]) accessible to the gas bubbles (Fig. 3, element “GF”; paragraph [0034]) is located within the isolation chamber (Fig. 3, element 108 “open interior area”; paragraph [0035]) above the opening (Fig. 3, element 104 “open base”).
Regarding claim 15, Strimple discloses wherein:
the isolation chamber (Fig. 3, element 108 “open interior area”; paragraph [0035]) has a top opening (Fig. 3, element 110 “top” is fluidly connected to element “draw pipe”; paragraph [0035] “Using the subject foam intercept system 90, generated foam GF may be transported to the foam retention tank 78 via one or more routes”).
Claims 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Strimple (US 20160289091) (previously cited) in view of Staheli (US 20110207218) (previously cited) as applied to claim 9, further in view of Vanhoutte (EP 2130902) (previously cited).
Regarding claim 10, Strimple discloses wherein:
the apparatus is disposed in the liquid (Fig. 3; paragraph [0043]) within a system such that a portion of the body portion extends above a liquid / gas interface (Fig. 3; paragraph [0043]); wherein when the apparatus is disposed in the liquid a portion of the apparatus extends above a liquid/gas interface within the vessel (Fig. 3; paragraph [0043]; the vessel is Fig. 3, element 56 “seawater aeration basin”);
wherein when the apparatus (Fig. 3, element 66 “foam intercept device”; paragraphs [0006] and [0034]) is disposed in the vessel (Fig. 3, element 56 “seawater aeration basin”; paragraph [0043]), a surface area of the liquid/gas interface (Fig. 3, element 86 is the surface of the effluent seawater; paragraph [0043]) accessible to the gas bubbles (Fig. 3, GF “generated foam”; paragraph [0043]) via the opening (Fig. 3, element 104 “open base”; paragraph [0035]); and
wherein the underside surface of the body portion (Fig. 3, element 102 “float frame”; paragraph [0034]) is configured to direct the gas bubbles within the liquid (Fig. 3, generated foam “GF” is diverted into element 104 “open base”, and the foam intercept device’s adjustable float frame can be just below the surface of the effluent seawater, thereby drawing the foam under the surface of the seawater; paragraph [0043]) towards the opening (Fig. 3, element 104 “open base”; paragraph [0035]) and to the liquid/gas interface (Fig. 3, element 86 is the surface of the effluent seawater; paragraph [0043]) accessible via the opening (Fig. 3, element 104 “open base”; paragraph [0035]).
Strimple does not disclose
the flexible bioprocessing bag and the bioprocessing system;
is reduced by the apparatus as compared to the surface area of the liquid/gas interface of the system accessible to the gas bubbles in the absence of the apparatus.
Regarding feature 1, Staheli discloses a flexible bioprocessing bag (Fig. 1, element 12 “container”; paragraphs [0024] and [0028]) and a bioprocessing system (Fig. 1, element 10 “system”).
In the analogous art of foam intercept systems, it would have been obvious to one skilled in the art before the effective filing date to modify the foam intercept system of Strimple with the bioreactor system of Staheli in order to help reduce foam levels within a flexible disposable bioreactor bag inside a vessel used in a bioprocessing system.
Regarding feature 2, regarding the limitation “is reduced by the apparatus as compared to the surface area of the liquid/gas interface of the system accessible to the gas bubbles in the absence of the apparatus”, this is an obvious change in the shape of the part. The claim limitation is obvious, as the configuration of the claimed shape is a matter of choice, absent persuasive evidence that the particular configuration is significant. MPEP § 2144.04(IV)(B). It would have been obvious to one skilled in the art before the effective filing date to modify the shape of the device of modified Strimple to reduce a surface area of the liquid/gas interface of the system accessible to the gas bubbles in order to more effectively collect the foam at the top of the opening of modified Strimple’s device, depending on the shape of the bioreactor bag or the vessel. Additionally, not only is changes in the shape of the foam intercept device of modified Strimple obvious, it is already present in Strimple’s specification (paragraph [0035] “round”, “square”, and “triangular” cross-sections, “depending on the shape thereof”).
Nevertheless, regarding feature 2, Vanhoutte inherently discloses the feature “is reduced by the apparatus as compared to the surface area of the liquid/gas interface of the system accessible to the gas bubbles in the absence of the apparatus” as Vanhoutte’s device is frusto-conical and tapers towards the top of the cylindrical reactor space (Fig. 4; paragraph [0021] referring to Fig. 4; paragraph [0032]).
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Vanhoutte, Figs. 4 and 5
In the analogous art of apparatuses for producing microorganisms, it would have been obvious to one skilled in the art before the effective filing date to modify the shape of the device of Strimple with the shape of Vanhoutte in order to push the downwards flow of microorganisms towards the sidewalls (for the purpose, e.g., of light penetration through the reactor for photosynthesis) as well as the central upward flow of the airstream which causes the reactor to be well-mixed without interference from air bubbles entering the downwards water flow (Vanhoutte, paragraphs [0045]-[0046]).
Regarding claim 11, Strimple discloses:
the underside surface of the body portion of the apparatus (Fig. 3, element 104 “open base”; paragraph [0035]) has a tapered shape (Fig. 3, sidewalls are tapered inwards near the top of the device), configured to direct the gas bubbles towards the opening and to the liquid / gas interface (Fig. 3, foam is suctioned into the opening as well as past the liquid / gas interface; paragraphs [0034]-[0035]).
Regarding the limitation “configured to direct the gas bubbles towards the opening and to the liquid / gas interface”, this is an intended use of the apparatus. The manner of operating or intended use of a claimed apparatus does not patentably distinguish it from the prior art. MPEP § 2114(II). The device of modified Strimple would be fully capable of operating in this manner given the tapered shape of the device.
Additionally, the claim limitation is obvious, as the configuration of the claimed shape is a matter of choice, absent persuasive evidence that the particular configuration is significant. MPEP § 2144.04(IV)(B). It would have been obvious to one skilled in the art before the effective filing date to modify the shape of the device of modified Strimple to be tapered to reduce a surface area of the liquid/gas interface of the system accessible to the gas bubbles in order to more effectively collect the foam at the top of the opening of Strimple’s device, depending on the shape of the bioreactor bag or the vessel. Additionally, not only is changes in the shape of the foam intercept device of Strimple obvious, it is already present in Strimple’s specification (paragraph [0035] “round”, “square”, and “triangular” cross-sections, “depending on the shape thereof”).
Nevertheless, regarding this feature, if it is deemed that Strimple does not disclose a tapered shape, Vanhoutte discloses “a tapered shape” as Vanhoutte’s device is frusto-conical and tapers towards the top of the cylindrical reactor space (Fig. 4; paragraph [0021] referring to Fig. 4; paragraph [0032]).
In the analogous art of apparatuses for producing microorganisms, it would have been obvious to one skilled in the art before the effective filing date to modify the shape of the device of modified Strimple with the tapered shape of Vanhoutte in order to push the downwards flow of microorganisms towards the sidewalls (for the purpose, e.g., of light penetration through the reactor for photosynthesis) as well as the central upward flow of the airstream which causes the reactor to be well-mixed without interference from air bubbles entering the downwards water flow (Vanhoutte, paragraphs [0045]-[0046]).
Regarding claim 12, Strimple discloses wherein: the underside surface (Fig. 3, element 104 “open base”; paragraph [0034]) has a frusto-conical shape (Fig. 3 and paragraph [0035] “round”).
Additionally, the claim limitation is obvious, as the configuration of the claimed shape is a matter of choice, absent persuasive evidence that the particular configuration is significant. MPEP § 2144.04(IV)(B). It would have been obvious to one skilled in the art before the effective filing date to modify the shape of the device of modified Strimple to be frusto-conical to reduce a surface area of the liquid/gas interface of the system accessible to the gas bubbles in order to more effectively collect the foam at the top of the opening of modified Strimple’s device, depending on the shape of the bioreactor bag or the vessel. Additionally, not only is changes in the shape of the foam intercept device of modified Strimple obvious, it is already present in Strimple’s specification (paragraph [0035] “round”, “square”, and “triangular” cross-sections, “depending on the shape thereof”).
Nevertheless, regarding this feature, if it is deemed that Strimple does not disclose a frusto-conical shape, Vanhoutte discloses a frusto-conical shape as Vanhoutte’s device is frusto-conical and tapers towards the top of the cylindrical reactor space (Fig. 4; paragraph [0021] referring to Fig. 4; paragraph [0032]).
In the analogous art of apparatuses for producing microorganisms, it would have been obvious to one skilled in the art before the effective filing date to modify the shape of the device of Strimple with the tapered shape of Vanhoutte in order to push the downwards flow of microorganisms towards the sidewalls (for the purpose, e.g., of light penetration through the reactor for photosynthesis) as well as the central upward flow of the airstream which causes the reactor to be well-mixed without interference from air bubbles entering the downwards water flow (Vanhoutte, paragraphs [0045]-[0046]).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 9 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 12-13 of copending Application No. 18044273 (Balakrishnan) (previously cited) in view of Staheli (US 20110207218) (previously cited). This is a provisional nonstatutory double patenting rejection.
Regarding claim 9, Balakrishnan discloses in its claims: a bioprocessing system (claim 12 “bioprocessing system”) comprising:
a vessel (claim 12 “a bioreactor”);
the vessel being configured to contain a volume of liquid (claim 12 “a fluid medium”); and
an apparatus (claim 12 “a sterile foam breaking system”) for reducing cell shear of cells within the liquid and / or for reducing foaming (claim 12 “foam breaking unit” configured to reduce foaming), the apparatus (claim 12 “a sterile foam breaking system”) being disposed within the vessel (claim 12 “a bioreactor”) and including:
a body portion (claim 12 “foam collector”) having an underside surface (claim 12, inherent to an object floating on a liquid gas interface); and
an opening in the body portion (claim 12 “a foam collector comprising an opening”);
wherein the underside surface of the body portion (claim 12, inherent to an object floating on a liquid gas interface) is configured to divert rising gas bubbles within the liquid (claim 12, “transfer foam via the opening of the foam collector from the bioreactor”; claim 13, a protruding portion comprises the opening, while the flat portion contacts a fluid medium filled in the bioreactor, so that the gas bubbles in the liquid rise to the protruding portion comprising the opening) towards the opening (claim 12 “a foam collector comprising an opening”).
Balakrishnan does not disclose in its claims:
a flexible bioprocessing bag positionable within the vessel, the flexible bioprocessing bag being configured to contain a volume of liquid.
Staheli discloses a flexible bioprocessing bag (Fig. 1, element 12 “container”; paragraphs [0024] and [0028]) positionable within the vessel (Fig. 1, element 30 “chamber”; paragraph [0025]), the flexible bioprocessing bag being configured to contain a volume of liquid (paragraph [0022]).
In the analogous art of foam intercept systems, it would have been obvious to one skilled in the art before the effective filing date to modify the foam intercept system of modified Balakrishnan with the bioreactor system of Staheli in order to help reduce foam levels within a flexible disposable bioreactor bag.
Claims 10-12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 12-13 of copending Application No. 18044273 (Balakrishnan) (previously cited) in view of Staheli (US 20110207218) (previously cited) as applied to claim 9, further in view of Strimple (US 20160289091) (previously cited) and Vanhoutte (EP 2130902) (previously cited). This is a provisional nonstatutory double patenting rejection.
Regarding claim 10, Balakrishnan discloses in its claims: wherein:
the apparatus (claim 12 “a sterile foam breaking system”) is disposed in the liquid (claim 12 “a fluid medium”) within the vessel (claim 12 “a bioreactor”) such that a portion of the body portion extends above (claim 12 “float on a fluid medium”) a liquid/gas interface (claim 12 “liquid gas interface”); wherein when the apparatus (claim 12 “a sterile foam breaking system”) is disposed in the liquid a portion of the apparatus extends above (claim 12 “float on a fluid medium”) a liquid/gas interface (claim 12 “liquid gas interface”) within the vessel (claim 12 “a bioreactor”).
Balakrishnan does not disclose in its claims:
a flexible bioprocessing bag;
wherein when the apparatus is disposed in the vessel a surface area of the liquid/gas interface accessible to the gas bubbles via the opening
is reduced by the apparatus as compared to the surface area of the liquid / gas interface of the bioprocessing system accessible to the gas bubbles in the absence of the apparatus; and,
wherein the underside surface of the body portion is configured to direct the gas bubbles within the liquid towards the opening and to the liquid / gas interface accessible via the opening.
Regarding feature 1, Staheli discloses a flexible bioprocessing bag (Fig. 1, element 12 “container”; paragraphs [0024] and [0028]).
In the analogous art of foam intercept systems, it would have been obvious to one skilled in the art before the effective filing date to modify the foam intercept system of modified Balakrishnan with the bioreactor system of Staheli in order to help reduce foam levels within a flexible disposable bioreactor bag.
Regarding feature 2, Strimple discloses wherein when the apparatus (Fig. 3, element 66 “foam intercept device”; paragraphs [0006] and [0034]) is disposed in the vessel (Fig. 3, element 56 “seawater aeration basin”; paragraph [0043]), a surface area of the liquid/gas interface (Fig. 3, element 86 is the surface of the effluent seawater; paragraph [0043]) accessible to the gas bubbles (Fig. 3, GF “generated foam”; paragraph [0043]) via the opening (Fig. 3, element 104 “open base”; paragraph [0035]).
In the analogous art of foam intercept systems, it would have been obvious to one skilled in the art before the effective filing date to modify the apparatus of modified Balakrishnan with the orientation and location of the apparatus with respect to the liquid / gas interface as in Strimple in order to suction foam away from the surface of the bioreactor medium.
Regarding feature 3, regarding the limitation “is reduced by the apparatus as compared to the surface area of the liquid/gas interface of the system accessible to the gas bubbles in the absence of the apparatus”, this is an obvious change in the shape of the part. The claim limitation is obvious, as the configuration of the claimed shape is a matter of choice, absent persuasive evidence that the particular configuration is significant. MPEP § 2144.04(IV)(B). It would have been obvious to one skilled in the art before the effective filing date to modify the shape of the device of modified Balakrishnan to reduce a surface area of the liquid/gas interface of the system accessible to the gas bubbles in order to more effectively collect the foam at the top of the opening of modified Balakrishnan’s device, depending on the shape of the bioreactor bag or the vessel.
Nevertheless, regarding feature 3, Vanhoutte inherently discloses the feature “is reduced by the apparatus as compared to the surface area of the liquid/gas interface of the system accessible to the gas bubbles in the absence of the apparatus” as Vanhoutte’s device is frusto-conical and tapers towards the top of the cylindrical reactor space (Fig. 4; paragraph [0021] referring to Fig. 4; paragraph [0032]).
In the analogous art of apparatuses for producing microorganisms, it would have been obvious to one skilled in the art before the effective filing date to modify the shape of the device of modified Balakrishnan with the shape of Vanhoutte in order to push the downwards flow of microorganisms towards the sidewalls (for the purpose, e.g., of light penetration through the reactor for photosynthesis) as well as the central upward flow of the airstream which causes the reactor to be well-mixed without interference from air bubbles entering the downwards water flow (Vanhoutte, paragraphs [0045]-[0046]).
Regarding feature 4, Strimple discloses: wherein the underside surface of the body portion (Fig. 3, element 102 “float frame”; paragraph [0034]) is configured to direct the gas bubbles within the liquid (Fig. 3, generated foam “GF” is diverted into element 104 “open base”, and the foam intercept device’s adjustable float frame can be just below the surface of the effluent seawater, thereby drawing the foam under the surface of the seawater; paragraph [0043]) towards the opening (Fig. 3, element 104 “open base”; paragraph [0035]) and to the liquid/gas interface (Fig. 3, element 86 is the surface of the effluent seawater; paragraph [0043]) accessible via the opening (Fig. 3, element 104 “open base”; paragraph [0035]).
In the analogous art of foam intercept systems, it would have been obvious to one skilled in the art before the effective filing date to modify the apparatus of modified Balakrishnan with the orientation and location of the apparatus’s opening with respect to the liquid / gas interface and gas bubbles as in Strimple in order to suction foam away from the surface of the bioreactor medium.
Regarding claim 11, Balakrishnan discloses in its claims: the underside surface of the body portion of the apparatus (claim 12, inherent to an object floating on a liquid gas interface), the gas bubbles (claim 12, “transfer foam via the opening of the foam collector from the bioreactor”), the opening (claim 12 “a foam collector comprising an opening”), and the liquid/gas interface (claim 12 “liquid gas interface”).
Balakrishnan does not disclose in its claims: wherein:
the underside surface of the body portion of the apparatus has a tapered shape, configured to direct the gas bubbles towards the opening and to the liquid/gas interface.
Strimple discloses wherein:
the underside surface of the body portion of the apparatus (Fig. 3, element 104 “open base”; paragraph [0035]) has a tapered shape (Fig. 3, sidewalls are tapered inwards near the top of the device), configured to direct the gas bubbles towards the opening and to the liquid / gas interface (Fig. 3, foam is suctioned into the opening as well as past the liquid / gas interface; paragraphs [0034]-[0035]).
In the analogous art of foam intercept systems, it would have been obvious to one skilled in the art before the effective filing date to modify the apparatus of modified Balakrishnan with the tapered shape of the underside of the body portion of the apparatus of Strimple in order have a central upward flow of the airstream which causes a reactor (such as an airlift reactor) to be well-mixed without interference from air bubbles entering the downwards water flow (Vanhoutte, paragraphs [0045]-[0046]).
Regarding the limitation “configured to direct the gas bubbles towards the opening and to the liquid / gas interface”, this is an intended use of the apparatus. The manner of operating or intended use of a claimed apparatus does not patentably distinguish it from the prior art. MPEP § 2114(II). The device of modified Balakrishnan would be fully capable of operating in this manner given the tapered shape of the device.
Additionally, the claim limitation is obvious, as the configuration of the claimed shape is a matter of choice, absent persuasive evidence that the particular configuration is significant. MPEP § 2144.04(IV)(B). It would have been obvious to one skilled in the art before the effective filing date to modify the shape of the device of modified Balakrishnan to be tapered to reduce a surface area of the liquid/gas interface of the system accessible to the gas bubbles in order to more effectively collect the foam at the top of the opening of Balakrishnan’s device, depending on the shape of the bioreactor bag or the vessel.
Nevertheless, regarding this feature, if it is deemed that modified Balakrishnan does not disclose a tapered shape in its claims, Vanhoutte discloses “a tapered shape” as Vanhoutte’s device is frusto-conical and tapers towards the top of the cylindrical reactor space (Fig. 4; paragraph [0021] referring to Fig. 4; paragraph [0032]).
In the analogous art of apparatuses for producing microorganisms, it would have been obvious to one skilled in the art before the effective filing date to modify the shape of the device of modified Balakrishnan with the tapered shape of Vanhoutte in order to push the downwards flow of microorganisms towards the sidewalls (for the purpose, e.g., of light penetration through the reactor for photosynthesis) as well as the central upward flow of the airstream which causes the reactor to be well-mixed without interference from air bubbles entering the downwards water flow (Vanhoutte, paragraphs [0045]-[0046]).
Regarding claim 12, Balakrishnan discloses in its claims: the underside surface (claim 12, inherent to an object floating on a liquid gas interface).
Balakrishnan does not disclose in its claims: wherein the underside surface has a frusto-conical shape.
Strimple discloses wherein: the underside surface (Fig. 3, element 104 “open base”; paragraph [0034]) has a frusto-conical shape (Fig. 3 and paragraph [0035] “round”).
Additionally, the claim limitation is obvious, as the configuration of the claimed shape is a matter of choice, absent persuasive evidence that the particular configuration is significant. MPEP § 2144.04(IV)(B). It would have been obvious to one skilled in the art before the effective filing date to modify the shape of the device of modified Balakrishnan to be frusto-conical to reduce a surface area of the liquid/gas interface of the system accessible to the gas bubbles in order to more effectively collect the foam at the top of the opening of Balakrishnan’s device, depending on the shape of the bioreactor bag or the vessel.
Nevertheless, regarding this feature, if it is deemed that modified Balakrishnan does not disclose a frusto-conical shape, Vanhoutte discloses a frusto-conical shape as Vanhoutte’s device is frusto-conical and tapers towards the top of the cylindrical reactor space (Fig. 4; paragraph [0021] referring to Fig. 4; paragraph [0032]).
In the analogous art of apparatuses for producing microorganisms, it would have been obvious to one skilled in the art before the effective filing date to modify the shape of the device of modified Balakrishnan with the tapered shape of Vanhoutte in order to push the downwards flow of microorganisms towards the sidewalls (for the purpose, e.g., of light penetration through the reactor for photosynthesis) as well as the central upward flow of the airstream which causes the reactor to be well-mixed without interference from air bubbles entering the downwards water flow (Vanhoutte, paragraphs [0045]-[0046]).
Claim 13 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 12-13 of copending Application No. 18044273 (Balakrishnan) (previously cited) in view of Staheli (US 20110207218) (previously cited) as applied to claim 9, further in view of claims 1 and 4 of copending Application No. 18044273 (Balakrishnan) (previously cited). This is a provisional nonstatutory double patenting rejection.
Regarding claim 13, Balakrishnan discloses in its claims: wherein: the underside surface has a plurality of grooves configured to facilitate coalescence of the gas bubbles (claim 4, as dependent on claim 1, “serrations”).
It would have been obvious to one skilled in the art before the effective filing date to modify modified Balakrishnan’s apparatus with the embodiment from Balakrishnan’s claim 4 in order to form a foam breaking unit within the tubular opening of the foam breaking system (Balakrishnan, claim 4), or, additionally, to include a plurality of grooves to increase the surface area of the device accessible to the gas bubbles in order to more effectively collect the foam at the top of the opening of modified Balakrishnan’s device, depending on the shape of the bioreactor bag or the vessel.
Additionally, the presence of a plurality of grooves is an obvious change in shape, as the configuration of the claimed shape is a matter of choice, absent persuasive evidence that the particular configuration is significant. MPEP § 2144.04(IV)(B). It would have been obvious to one skilled in the art before the effective filing date to modify the shape of the device of modified Balakrishnan to include a plurality of grooves to increase the surface area of the device accessible to the gas bubbles in order to more effectively collect the foam at the top of the opening of modified Balakrishnan’s device, depending on the shape of the bioreactor bag or the vessel.
Claims 14-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 12-13 of copending Application No. 18044273 (Balakrishnan) (previously cited) in view of Staheli (US 20110207218) (previously cited) as applied to claim 9, further in view of Strimple (US 20160289091) (previously cited). This is a provisional nonstatutory double patenting rejection.
Regarding claim 14, Balakrishnan discloses in its claims: wherein:
the apparatus (claim 12 “a sterile foam breaking system”) further includes the body portion (claim 12 “foam collector”) and the opening (claim 12 “a foam collector comprising an opening”), a peripheral wall (claim 13, “protruding portion”) extending upwardly from the body portion (claim 13, “extending from the flat portion”), the liquid/gas interface (claim 12 “liquid gas interface”) accessible to the gas bubbles (Fig. 3, GF “generated foam”; paragraph [0043]) is located above the opening (claim 12 “a foam collector comprising an opening”).
Balakrishnan does not disclose in its claims:
a peripheral wall extending upwardly from the body portion and circumscribing the opening, the peripheral wall defining an isolation chamber therein;
wherein the liquid/gas interface accessible to the gas bubbles is located within the isolation chamber above the opening.
Strimple discloses wherein:
a peripheral wall (Fig. 3, element 106 “one or more walls”; paragraph [0035]) extending upwardly from the body portion (Fig. 3, element 102 “float frame”; paragraph [0034]) and circumscribing the opening (Fig. 3, element 104 “open base”), the peripheral wall (Fig. 3, element 106 “one or more walls”; paragraph [0035]) defining an isolation chamber therein (Fig. 3, element 108 “open interior area”; paragraph [0035]);
wherein the liquid / gas interface (Fig. 3, element 86 “surface 86 of effluent seawater”; paragraph [0034]) accessible to the gas bubbles (Fig. 3, element “GF”; paragraph [0034]) is located within the isolation chamber (Fig. 3, element 108 “open interior area”; paragraph [0035]) above the opening (Fig. 3, element 104 “open base”).
In the analogous art of foam breaking systems, it would have been obvious to one skilled in the art before the effective filing date to modify the apparatus of modified Balakrishnan with the peripheral wall and isolation chamber of Strimple in order to help collect and isolate gas bubbles and foam from the bioreactor so that the gas bubbles and foam can be eliminated or suctioned and/or pumped out of the bioreactor.
Regarding claim 15, Balakrishnan does not disclose in its claims: wherein: the isolation chamber has a top opening.
Strimple discloses wherein:
the isolation chamber (Fig. 3, element 108 “open interior area”; paragraph [0035]) has a top opening (Fig. 3, element 110 “top” is fluidly connected to element “draw pipe”; paragraph [0035] “Using the subject foam intercept system 90, generated foam GF may be transported to the foam retention tank 78 via one or more routes”).
In the analogous art of foam breaking systems, it would have been obvious to one skilled in the art before the effective filing date to modify the apparatus of modified Balakrishnan with the top opening of the isolation chamber of Strimple in order to help collect and isolate gas bubbles and foam from the bioreactor so that the gas bubbles and foam can be eliminated or suctioned and/or pumped out of the bioreactor.
Additional Prior Art References
The prior art made of record and not relied upon is considered pertinent to Applicant’s disclosure.
Salek (“Mineral CO2 sequestration by environmental biotechnological processes”) (newly cited) – This non-patent literature in part describes desulfurization using a bioreactor (see Box 2).
Ruitenberg (“Biologically Removing Sulfur from Dilute Gas Flows”) (newly cited) – This non-patent literature describes biologically treating sulfur.
De (US 20230348834) (newly cited) – This disclosure describes the inventor De’s invention on how to reduce foam using a particularly shaped fountain head (see Fig. 5D and paragraph [0046]).
Response to Arguments
Applicant’s arguments filed 07/21/2026 have been fully considered but they are not persuasive.
Regarding the specification objections, the amendments have been noted, the majority of the previous specification objections are withdrawn, with the exception of the objections to the marks used in commerce above.
Regarding the claim objections, the amendments have been noted. The previous claim objections are withdrawn.
Regarding the rejections under 35 U.S.C. § 112(b), the amendments have been noted. The previous rejections are withdrawn.
The following response to arguments section pertains to the rejections under 35 U.S.C. § 103:
Regarding pg. 9 of 14, the standards for analogous art apply to Strimple. In response to Applicant’s argument that Strimple is nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, Strimple is a foam collecting device and is therefore analogous art under the particular problem with which the inventor was concerned (bubbles and foam collection in a vessel containing aqueous material). Prong (2) is satisfied under this reasoning. Prong (1) may be satisfied as Strimple is classified under B01D19/02 “Foam dispersion or prevention” and C02F2303/12 “Prevention of foaming”. If it is deemed that Prong (1) is not satisfied for Strimple, as the invention of Strimple also belongs to the art of seawater flue gas desulfurization and is classified under C02F1/40, only one of the two prongs are necessary for the analogous art requirement to be fulfilled.
Regarding pg. 9 of 14 about the arguments rebutting the claim mapping of Strimple to the instantly claimed invention, Strimple’s invention discloses the majority of limitations of independent claim 9. Applicant has not claimed that the device is “‘just below’ the surface” in instant independent claim 9 or any other currently examined claim. Instead, this was meant as an explanatory feature of Strimple (as is recited in Strimple, claim 1). Additionally, it could be necessary for part of the device to be just below the surface of the water to float on the water based on the density of a solid object; also, according to Strimple’s paragraph [0043]:
The subject method may further comprise adjusting the float frame 102 to vary the distance D of the housing 100 open base 104 with respect to the surface 86 of the effluent seawater ES.
-- Strimple, paragraph [0043]
Therefore, Strimple’s invention can float on the surface of the seawater, have a portion just below the surface of the seawater, and collect foam. Conversely, in claim 10, “a portion of the body portion extends above a liquid/gas interface”, which could be any amount of a portion of the device, which Strimple’s invention satisfies. Applicant arguments are not commensurate in scope with the claimed subject matter, as the surface skimming device of modified Strimple can be used to satisfy the current claim set: at no point in the claims is the word “submerged” used to describe the instant invention. However, Applicant’s instant Figs. 3 and 6-7 show partial submergent.
Regarding claim 9, specifically the phrase “wherein the underside surface of the body portion is configured to divert rising gas bubbles within the liquid towards the opening” the examiner has recited the following description based on Strimple:
Fig. 3, generated foam “GF” is diverted into element 104 “float frame”, and the foam intercept device’s adjustable float frame can be just below the surface of the effluent seawater, thereby drawing the foam under the surface of the seawater; paragraph [0043]
The pressure difference generated by Strimple’s suction force would draw foam into the device. Rising bubbles near the top of the surface of the liquid would interact with the underside of the foam layer and would be drawn into the device past the adjustable height of the float frame. Then, the bubbles rising through the liquid are drawn into the device towards the opening as foam. Modifying the adjustable height of the float frame to guide the rising bubbles into the housing of the device in order to collect foam is within the purview of Strimple’s paragraph [0043], and see Fig. 2, below.
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Strimple, Fig. 2
Regarding pg. 11 of 14, in response to Applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, 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). In this case, the motivation was given:
In the analogous art of foam intercept systems, it would have been obvious to one skilled in the art before the effective filing date to modify the foam intercept system of Strimple with the bioreactor system of Staheli in order to help reduce foam levels within a flexible disposable bioreactor bag.
Considering that Strimple’s device collects foam, and that Staheli discloses a bioreactor bag, it would have been obvious to make the combination for the reasons stated above. For further explanation on how desulfurization works from using an additional biotechnological perspective, the Additional Prior Art is given Salek (“Mineral CO2 sequestration by environmental biotechnological processes”) and Ruitenberg (“Biologically Removing Sulfur from Dilute Gas Flows”).
In response to Applicant’s argument that the examiner’s conclusion of obviousness is based upon improper hindsight reasoning, 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). It would have been obvious to one skilled in the art before the effective filing date to modify Strimple with the bioreactor of Staheli in order to reduce levels of antifoam needed in a bioreactor, due to less foaming because of the foam skimming device of Strimple.
Regarding pg. 12 of 14, in response to the rejections of claims 10-12, Vanhoutte discloses a geometry that forces a particular fluid path that would allow bubbles to coalesce in a particular central opening, notably for an air-lift bioreactor, see Figs. 4-5 and paragraph [0042] of Vanhoutte.
Regarding the obvious change in the shape of parts over claim 11, arguably, the tapered shape of the collection device of Strimple is obvious in order to more effectively collect the foam at the top of the opening of Strimple’s device, depending on the shape of the bioreactor bag or the vessel.
Regarding the obvious change in the shape of parts over claim 12, a tapered shape may still present numerous possible configurations (pyramidal, conical, half of an hourglass, dome, hemisphere, or other shapes) and still achieve the same effect. The rejections over claim 12 is maintained due to the obvious change in the shape of parts for this reason. Additionally, a similar concept is already present in Strimple’s specification (paragraph [0035] “round”, “square”, and “triangular” cross-sections, “depending on the shape thereof”).
Additionally, regarding the dependent claims, these claims are rejected as the independent claim is still rejected, and no further arguments were made regarding the dependent claims.
Regarding the double patenting rejections, the incorrect format is used for the patent number on the Terminal Disclaimer form. Please resubmit the information on PTO/AIA /25 (04-13) for pending reference or PTO/AIA /26 (04-14) for prior patent. It appears that the wrong form was used (i.e. a T.D. over a patent form was used).
Conclusion
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATHAN G ESPERON whose telephone number is (571)272-9807. The examiner can normally be reached 9 am - 6 pm Monday through Thursday, and 9 am - 6 pm every other Friday.
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/N.G.E./Examiner, Art Unit 1799
/MICHAEL A MARCHESCHI/Supervisory Patent Examiner, Art Unit 1799
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