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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 1/23/2026 has been entered.
Response to Arguments
Applicant's arguments filed 1/23/2026 have been fully considered but they are not persuasive.
Applicant argues on pp. 2-3 of Remarks that neither Goodwin et al. nor Ermatov et al. describe or suggest pores of a first size being between 2 and 18 millimeters in diameter and configured to allow for passage of gas through the first layer and configured to inhibit passage of water through the first layer. This is not persuasive because Goodwin et al. teaches a pore size of “about 20 µm” (para. 0060), which is close to the claimed pore size of 18 micrometers, and it has been held that a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close (MPEP § 2144.05 I). It is also to be noted that “about” permits some tolerance. Goodwin et al. also discloses that the material of the sparging sheet (of which the first sparging layer is made of) “is both vapor-permeable and water-resistant. That is, although the gas can pass through sparging sheet 64, water and some other fluids are prevented from flowing therethrough” (para. 0054). Therefore, Goodwin et al. discloses that the pore size of “about 20 µm” allows for passage of gas and inhibits the passage of water.
Additionally, Ermatov et al. teaches a pore diameter of 0.01 to 10 µm (para. 0051) that overlaps the claimed range of 2 to 18 micrometers, which will be discussed in further detail in the 35 USC § 103 section below. Ermatov et al. discloses that the porous body allows gas flow through it (para. 0102) and no aqueous liquid counterflows to the gas feeding side with a fine pore size (0.01 to 10 µm) (para. 0052). Therefore, Ermatov et al. also teaches that a pore size overlapping the claimed range allows for passage of gas and inhibits the passage of water.
Applicant argues on p. 3 of Remarks that Goodwin et al. does not describe a housing as recited in the present claims. This is not persuasive, as Goodwin et al. discloses a housing in which a gas sparger is mounted (para. 0003 “container systems that incorporate a gas sparger”; Fig. 1). Applicant argues further that the sparging sheets of Goodwin et al. extend to an outermost portion of the sparger and, as such, are not mounted within a housing as recited by the present claims. This is not persuasive, as this structure is not commensurate in scope with the claims and Goodwin et al. describes a housing structure that reads on the claimed housing.
Applicant also argues on p. 3 of Remarks that an advantage of the sandwiched-layer sparger construction of the claimed invention is that this structure may be incorporated into many different sparger configurations, contrary to the sparger disclosed by Goodwin et al. This is not persuasive because this feature is a recitation of the intended use of the apparatus and does not distinguish the claimed invention over the prior art. It has been held that apparatus claims cover what a device is, not what a device does (MPEP § 2114 II), and using the claimed sparger in different configurations does not introduce a structural difference between the prior art and the claimed invention.
Applicant also argues on p. 3 of Remarks that neither Goodwin et al. nor Ermatov et al. describe or suggest that the plurality of holes of a second size and a flow rate are chosen to produce bubbles of a desired size. This is not persuasive, as Goodwin et al. discloses that the sparging sheets can be selected and sized to disperse the gas as micro-bubbles having a desired size over a desired area (para. 0028). Additionally, Applicant argues that this is a benefit of the claimed invention as this benefit is not contemplated by either Goodwin et al. or Ermatov et al. However, this is not persuasive because this feature is a recitation of the intended use of the apparatus and does not distinguish the claimed invention over the prior art. It has been held that a claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim (MPEP § 2114 II), and using the claimed invention to produce bubbles of a desired size does not introduce a structural difference between the prior art and the claimed invention as Goodwin et al. discloses sparging sheets sized to disperse gas as micro-bubbles having a desired size over a desired area (para. 0028).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1 and 3-11 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 is directed to an apparatus, but contains method step limitations: “wherein the second size and a flow rate are chosen to produce bubbles of a desired size” (line 14). A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite (MPEP § 2173.05(p)).
Dependent claims are rejected for the same reason as the base claim(s) upon which they depend.
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.
Claims 1 and 3-10 are rejected under 35 U.S.C. 103 as being unpatentable over Goodwin et al. (US 2006/0270036 A1) (already of record) in view of Ermatov et al. (US 2018/0085717 A1) (already of record).
Regarding claim 1, Goodwin et al. teaches a sparger assembly (Fig. 10 190 sparger) comprising a first layer (Fig. 10 196 second sparging sheet) having a plurality of pores of a first size (para. 0060 “small perforated holes”); and a second layer disposed above the first layer (Fig. 10 194 first sparging sheet) and having a plurality of holes of a second size (para. 0060 “small perforated holes”), the second size capable of being greater than the first size; and a housing, the first layer being mounted within the housing and the second layer being mounted within the housing and disposed above the first layer, forming a sandwich therewith (para. 0003 “container systems that incorporate a gas sparger”; Fig. 1); wherein the pores of the first layer and the holes of the second layer are configured to be sized to allow for passage of a sparge gas through the first layer and the second layer (abstract “gas permeable material”), and configured to allow for passage of gas through the first layer and configured to inhibit passage of water through the first layer (para. 0054), wherein the first layer is made of a hydrophobic material that inhibits backflow of the water to a sparge gas supply (para. 0054 “sparging sheet 64 is comprised of a material that is both vapor-permeable and water-resistant. That is, although the gas can pass through sparging sheet 64, water and some other fluids are prevented from flowing therethrough… material with high permeability while maintaining hydrophobicity”), wherein the second size and a flow rate are chosen to produce bubbles of a desired size (para. 0028 “the flexible, gas permeable sparging sheets can be selected and sized to disperse the gas as micro-bubbles having a desired size over a desired area”; para. 0072).
Goodwin et al. teaches the housing (Fig. 1) and the sparger comprised of two layers (Fig. 10) as different embodiments. However, Goodwin et al. teaches that a sparger disposed in a bioreactor container is known in the art (para. 0005), and the substitution of one known element for another would have predictably resulted in an apparatus that delivers controlled volumes of gas to a growth media containing cells (para. 0005) with reasonable expectation. Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the sparger in the container of Fig. 1 with the sparger of Fig. 10.
Goodwin et al. does not explicitly teach the holes of a second size being greater than the first size, but does teach that the size of the holes can range from about 20 µm to about 5 mm (para. 0060). Therefore, the holes of a second size are capable of being greater than the holes of a first size.
Goodwin et al. teaches a pore size of “about 20 µm” (para. 0060), but does not teach a size between 2 and 18 micrometers in diameter. However, it has been held that a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close (MPEP § 2144.05 I). The claimed range is obvious in view of Goodwin et al. because Goodwin et al. discloses a pore size of “about 20 µm” which is close to the claimed range of between 2 and 18 micrometers. It is also to be noted that the term “about” permits some tolerance.
Nonetheless, Ermatov et al. teaches a pore diameter of 0.01 to 10 µm (para. 0051). It has been held that in the case where the claimed ranges overlap or lie inside ranges disclosed by the prior art, a prima facie case of obviousness exists (MPEP § 2144.05). The claimed range is obvious in view of Ermatov et al. because Ermatov et al. discloses a range of 0.01 to 10 µm, which overlaps the claimed range of between 2 and 18 micrometers. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select the claimed range from the broader prior art range because the prior art teaches the same utility over the entire range.
Ermatov et al. also teaches that the pore size influences the gas flow through the porous body (para. 0102) and no aqueous liquid counterflows to the gas feeding side with a fine pore size (0.01 to 10 µm) (para. 0052). It would have been obvious to a person of ordinary skill in the art to use the Ermatov et al. configuration of a pore diameter of 0.01 to 10 µm in Goodwin et al.’s device with a reasonable expectation that it would influence the gas flow through the porous body and no aqueous liquid would counterflow to the gas feeding side. This method for improving Goodwin et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Ermatov et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Goodwin et al. and Ermatov et al. to obtain the invention as specified in claim 1.
Regarding claim 3, Goodwin et al. teaches a sparger assembly wherein the first layer is hydrophobic (para. 0057 “hydrophobicity”), but does not teach wherein the first layer has a three-dimensionally interconnected pore structure. However, Ermatov et al. teaches interconnected pores (para. 0097) which improve the distribution of gas over a large area (para. 0099).
It would have been obvious to a person of ordinary skill in the art to use the Ermatov et al. configuration of interconnected pores in Goodwin et al.’s device with a reasonable expectation that it would not allow liquid to extend too far into the material towards the gas supply. This method for improving Goodwin et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Ermatov et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Goodwin et al. and Ermatov et al. to obtain the invention as specified in claim 3.
Regarding claim 4, Goodwin et al. teaches wherein the first layer is formed from a hydrophobic material (para. 0057 “hydrophobicity”). Goodwin et al. does not explicitly teach that the first layer is formed from a sintered material, but does teach that a sintered material is a known element in the art (para. 0005 “sintered metal”). Nonetheless, it would have been obvious to a person of ordinary skill in the art to use a sintered material because the substitution of one known element for another would have predictably resulted in a porous material that allows passage of a sparge gas through the layer of material with reasonable expectation. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the teachings of Goodwin et al. to obtain the invention as specified in claim 4.
Regarding claim 5, Goodwin et al. teaches a sparger assembly wherein the second layer has a plurality of discrete holes through the second layer (para. 0060 “small perforated holes”).
Regarding claim 6, Goodwin et al. teaches a sparger assembly comprising perforated holes (para. 0060). Goodwin et al. does teach that the holes can be produced by being punched or embossed (para. 0060), but does not teach wherein the second layer is configured as a drilled hole sparger. However, it has been held that the patentability of a product does not depend on its method of production; if the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior art product was made by a different process (MPEP § 2113 I). Therefore, the apparatus disclosed by Goodwin et al. would be fully capable of allowing the passage of gas through the material because the prior art apparatus is disclosed to have perforated holes (para. 0060) and would be structurally capable of allowing passage of a sparge gas through a layer of material.
Regarding claim 7, Goodwin et al. teaches a sparger assembly wherein the holes are about 20 micrometers in diameter (para. 0060), but does not teach wherein the first size is between about 2 and about 15 micrometers in diameter. However, Ermatov et al. teaches a pore diameter of 0.01 to 10 µm (para. 0051). It has been held that in the case where the claimed ranges overlap or lie inside ranges disclosed by the prior art, a prima facie case of obviousness exists (MPEP § 2144.05). The claimed range is obvious in view of Ermatov et al. because Ermatov et al. discloses a range of 0.01 to 10 µm, which overlaps the claimed range of about 2 and about 15 micrometers. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select the claimed range from the broader prior art range because the prior art teaches the same utility over the entire range.
Ermatov et al. also teaches that the pore size influences the gas flow through the porous body (para. 0102) and no aqueous liquid counterflows to the gas feeding side with a fine pore size (0.01 to 10 µm) (para. 0052). It would have been obvious to a person of ordinary skill in the art to use the Ermatov et al. configuration of a pore diameter of 0.01 to 10 µm in Goodwin et al.’s device with a reasonable expectation that it would influences the gas flow through the porous body and no aqueous liquid would counterflow to the gas feeding side. This method for improving Goodwin et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Ermatov et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Goodwin et al. and Ermatov et al. to obtain the invention as specified in claim 7.
Regarding claim 8, Goodwin et al. teaches a sparger assembly wherein the second size is between about 100 and about 500 micrometers in diameter (para. 0060 “about 20 µm to about 500 µm”). It has been held that in the case where the claimed ranges overlap or lie inside ranges disclosed by the prior art, a prima facie case of obviousness exists (MPEP § 2144.05). The claimed range is obvious in view of Goodwin et al. because Goodwin et al. discloses a range of about 20 µm to about 500 µm, that overlaps the claimed range of about 100 and about 500 micrometers.
Regarding claim 9, Goodwin et al. teaches a sparger assembly further comprising a housing receiving the first layer and the second layer (Fig. 1 32 container), the housing being configured to receive a sparge gas from a supply (Fig. 1 96 gas line); wherein the sparge gas supplied to the housing is permitted to pass through the first layer and the second layer into a bioprocessing vessel (para. 0053 “gas permeable”); and wherein the first pore size of the first layer is such that water is not permitted to pass from the bioprocessing vessel past the first layer (paragraph 0054 “only allow gas to pass therethrough… hydrophobicity”).
Regarding claim 10, Goodwin et al. teaches a sparger assembly wherein the first layer is gas permeable and water impermeable (para. 0054 “only allow gas to pass therethrough… hydrophobicity”).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Goodwin et al. (US 2006/0270036 A1) (already of record) in view of Ermatov et al. (US 2018/0085717 A1) (already of record) as applied to claim 1 above, and further in view of Esteves et al. (US 2017/0314045 A1) (already of record).
Regarding claim 11, Goodwin et al. teaches a sparger assembly wherein the second layer is gas permeable (para. 0053 “gas permeable”), but is silent to the second layer being water permeable. However, Esteves et al. teaches a water permeable membrane (para. 0146) which separates concentrate in the container from liquid in the reaction vessel and remains impermeable to metal ions and macromolecules (para. 0146).
It would have been obvious to a person of ordinary skill in the art to use the Esteves et al. configuration of a water permeable membrane in modified Goodwin et al.’s device with a reasonable expectation that it would separate concentrate from liquid and remain impermeable to metal ions and macromolecules. This method for improving modified Goodwin et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Esteves et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of modified Goodwin et al. and Esteves et al. to obtain the invention as specified in claim 11.
Citation of Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Schmit et al. (US 6,200,468) discloses an aeration system comprising a porous member formed by multiple layers.
Conclusion
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/ASHLEY LOPEZLIRA/Examiner, Art Unit 1799
/MICHAEL A MARCHESCHI/Supervisory Patent Examiner, Art Unit 1799