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 .
Election/Restrictions
Claims 1-8 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 03/27/2026.
Applicant’s election with traverse of Invention II (claims 9-15) in the reply filed on 03/27/2026 is acknowledged. The traversal is on the grounds that:
The technical feature shared between Invention I (claims 1-8) and Invention II (claims 9-15) are special technical features.
The restriction’s prior art, Ward (US 5188946) (previously cited) does not disclose:
An apparatus that includes a body portion having an underside surface that diverts rising gas bubbles within the liquid towards an opening
Further arguments include:
Ward’s collection chamber is not an opening, it is a closed chamber
Ward’s passageway does not read on an underside surface
Ward’s passageway does not divert rising gas bubbles within a liquid towards the opening
This is not found persuasive because:
Ward’s collection chamber includes an opening at the apex of the underside surface (Fig. 6, element 30 “passageway”). The underside surface is a gas collection device (Fig. 6, element 10 “collection chamber”). The underside surface can be used for the function of diverting gas within a liquid towards the opening (col. 6, lines 3-11).
Additionally, the limitation “diverting gas within a liquid towards the opening” is a functional limitation that can be accomplished by Ward even without further modification. Regarding the limitation, 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 Ward would be fully capable of operating in this manner given the structure of Ward’s collection chamber.
The requirement is still deemed proper and is therefore made FINAL.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement(s) (IDS) were submitted on:
02/09/2023
Accordingly, the information disclosure statement(s) are being considered by the examiner.
Specification
The abstract of the disclosure is objected to because of a minor informality:
Regarding the abstract, in line 2, the phrase “a underside surface” should be “an underside surface”.
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
The disclosure is objected to because of the following informalities:
Regarding the specification, in paragraph [0007], the phrase “and reduced and turbidity” should be “and reduced turbidity”.
Regarding the specification, in paragraph [00010], the paragraph is indented twice instead of once.
Regarding the specification, in paragraph [00035], the phrase “(not shown)that” should be “(not shown) that” with a space within the phrase.
Regarding the specification, in paragraph [00036], the term “Puronic” should be “Pluronic®”.
Regarding the specification, in paragraph [00042], the term “thee gas/liquid interface” should be “the gas/liquid interface”.
Appropriate correction is required.
The use of the terms:
Fortem™ (paragraph [00026])
Bioclear™ 10 (paragraph [00026])
Bioclear™ 11 (paragraph [00026])
GE Healthcare® Life Sciences (paragraph [00026])
Pluronic® (paragraph [00036])
which are trade names or marks used in commerce, has 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.
Claim Objections
Claims 9-10 are objected to because of the following informalities:
Regarding claim 9, line 8, the phrase “a underside surface” should be “an underside surface”.
Regarding claim 10, line 3, the phrase “such that a portion the body portion” could be “such that a portion of the body portion”.
Regarding claim 10, line 4, the phrase “a portion the apparatus” could be “a portion of the apparatus”.
Regarding claim 10, line 10, the phrase “in the absence of the apparatus” could be “in an absence of the apparatus”, but this is optional.
Regarding claim 10, line 12, the phrase “direct gas bubbles” should be “direct the gas bubbles”.
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 10 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 10 recites the limitation “the bioreactor vessel” twice in lines 5 and 6. There is insufficient antecedent basis for this limitation in the claim. The two limitations could be phrased “the vessel”.
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) (newly cited) in view of Staheli (US 20110207218) (newly 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) (newly cited) in view of Staheli (US 20110207218) (newly cited) as applied to claim 9, further in view of Vanhoutte (EP 2130902) (newly 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 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, the bioreactor vessel, 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]), a bioreactor vessel (Fig. 1, element 30 “chamber”; paragraph [0025]), 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) (newly cited) in view of Staheli (US 20110207218) (newly 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) (newly cited) in view of Staheli (US 20110207218) (newly cited) as applied to claim 9, further in view of Strimple (US 20160289091) (newly cited) and Vanhoutte (EP 2130902) (newly 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 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 the apparatus extends above (claim 12 “float on a fluid medium”) a liquid/gas interface (claim 12 “liquid gas interface”) within the bioreactor vessel (claim 12 “a bioreactor”).
Balakrishnan does not disclose in its claims:
a flexible bioprocessing bag;
wherein when the apparatus is disposed in the bioreactor 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 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 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) (newly cited) in view of Staheli (US 20110207218) (newly cited) as applied to claim 9, further in view of claims 1 and 4 of copending Application No. 18044273 (Balakrishnan) (newly 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) (newly cited) in view of Staheli (US 20110207218) (newly cited) as applied to claim 9, further in view of Strimple (US 20160289091) (newly 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.
Hopkins (US 4752564) (newly cited) – This invention is a fermentation method and apparatus.
(DE 275498) (machine translation) (newly cited) – This invention is a method for decomposing sludge within a sludge container with guide walls.
Conclusion
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/N.G.E./Examiner, Art Unit 1799
/MICHAEL A MARCHESCHI/Supervisory Patent Examiner, Art Unit 1799
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