DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 29 April 2026 has been entered.
Claim Rejections - 35 USC § 103
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.
Claims 1-6, 9, 12-14, 17, 22 and 23 are rejected under 35 U.S.C. 103 as being obvious over Liu (US 20230092138) in view of Wolf (US 5707869) and Laurenson (US 5153137).
With respect to claims 1 and 9, Liu discloses a sparging device (Figure 5:210) comprising a medium chamber (Figure 5:1213) and a gas chamber (Figure 5:1214) that at least partially surrounds the medium chamber. The medium chamber and the gas chamber are separated from each other by a wall (Figure 5:212). The sparging device includes a gas inlet port (Figure 2A:214I) and a gas outlet port (Figure 2A:214O). The wall is fabricated from a microporous material (Figure 4C:212’) reinforced by inner (Figure 4C:216’) and outer (Figure 4C:215’) supports. It is unclear, however, if this structure reads on the claimed through-holes covered by a membrane cover.
Wolf discloses a device for oxygenating cells in a culture chamber. Gases in a gas chamber communicate with a medium chamber (Figure 2:40) across a wall (Figure 2:130) having a plurality of through-holes (Figure 2:140) extending through the wall. A membrane cover (Figure 2:120) is configured to cover the through-holes. This is taught in column 6, line 29 to column 7, line 27.
Laurenson discloses a sparing device comprising a medium chamber (Figure 1:12) and a gas chamber (Figure 1:26). The medium is separated from the gas chamber using a wall having a plurality of through-holes (Figure 4:52), wherein the through-holes are covered by a membrane cover (Figure 5:54). This is taught in column 4, line 49 to column 5, line 12.
Before the effective filing date of the claimed invention, it would have been obvious to ensure that the Liu gas chamber and medium chamber are separated from each other by a wall having a plurality of through-holes covered by a membrane cover. Lui, Wolf and Laurenson each indicate that a permeable membrane must be provided in order to regulate the delivery of gas across the membrane into the medium chamber. Wolf and Laurenson show how it is desirable to support the membrane over a wall having through-holes formed therethrough. Wolf, for example, teaches that the wall provides additional strength and rigidity to the membrane in instances where the form of the position and form of the membrane must be maintained (“Membrane support 110 stabilizes membrane 20…Membrane support 110 keeps membrane 20 from sagging and displacing culture medium 50 into cell culture compartment access port 70…Membrane support 110 is designed such that it will allow gas bubbles to move freely to cell culture compartment access port 70”).
With respect to claim 2, Lui, Wolf and Laurenson disclose the combination as described above. Liu shows in Fig. 2A that the medium chamber (and the sparging device as a whole) is cylindrical in shape.
With respect to claims 3 and 4, Lui, Wolf and Laurenson disclose the combination as described above. Liu teaches that the medium chamber has an inlet opening connected to an inlet connecting piece (Figure 2A:213I) and an outlet opening connected to an outlet connecting piece (Figure 2A:213O).
With respect to claims 5 and 6, Lui, Wolf and Laurenson disclose the combination as described above. Liu shows in Figs. 2A and 5 that the medium inlet and outlet openings are located at different ends of the medium chamber 1213 and that the gas inlet port 214I is located between the different ends to provide gas at a gas inflow direction that is transversely relative to a medium flow direction.
With respect to claim 12, Lui, Wolf and Laurenson disclose the combination as described above. Liu further shows that a pressure connecting piece (Figure 1:217) is formed at the gas inlet port to deliver gas to the sparging device.
With respect to claims 13 and 14, Lui, Wolf and Laurenson disclose the combination described above. Liu further shows that the gas chamber 1214 is divided into a plurality of gas chambers using plates 219. Paragraphs [0054]-[0058] of Liu teach that the plurality of gas chambers may be helically wound around the medium chamber. Although Liu does not expressly teach that a second gas inlet port opens into the second gas chamber, it is noted that the provision of a second gas inlet port represents a mere duplication of parts that produces a prima facie obvious cumulative and predictable result. See MPEP 2144.04 “Duplication of Parts”. A second gas opening providing gas to the second gas chamber would operate in the same manner as the first gas opening providing gas to the first gas chamber and would not fundamentally change how gases are delivered to the medium chamber.
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With respect to claim 17, Lui, Wolf and Laurenson disclose the combination as described above. Liu teaches that structures (Figure 2A:219) produce a desired flow behavior on gas flowing through the gas chamber.
With respect to claim 22, Lui, Wolf and Laurenson disclose the combination as described above. Liu states in paragraph [0053] that the device is made using materials suitable for sterilization via gamma radiation or an autoclave. Liu teaches polypropylene and polyethylene materials.
With respect to claim 23, Lui, Wolf and Laurenson disclose the combination as described above. Liu teaches a corresponding method in which the sparging device is used in a cell culture bioprocess. See Fig. 1.
Claims 7, 10 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Liu (US 20230092138) in view of Wolf (US 5707869) and Laurenson (US 5153137) as applied to claim 1, and further in view of Godfrey (US 20060033222).
With respect to claims 7 and 10, Lui, Wolf and Laurenson disclose the combination as described above, however Lui does not expressly state that the through-holes have a diameter in a range of approximately 0.15 to 0.18 mm, or that the density of the through-holes varies.
Laurenson additionally teaches in column 5, lines 1-12 that the density of through-holes in the wall varies along a flow direction (“The apertures 52 are illustrated with a first spacing along the length of an insert section 58 and a second spacing along the length of a second insert section 60”).
Godfrey discloses a sparging device comprising a medium chamber (Figure 7:63) and a gas chamber (see Fig. 1). The gas chamber is separated from the medium chamber by a wall having a plurality of through-holes (Figure 8:7). This is shown in Fig. 8. The gas chamber is in communication with at least one gas inlet port (Figure 2:4). This is described in paragraphs [0055]-[0058]. Godfrey states in paragraphs [0046] and [0047] that the diameter of the through-holes may be any suitable diameter and gives examples of 100 microns (0.1 mm) and 200 microns (0.2 mm). Godfrey additionally teaches in paragraph [0051] that the density of through-holes in the wall varies along a flow direction. More specifically, Godfrey teaches that spacing between adjacent through-holes may vary, which would cause the through-hole density to vary.
Before the effective filing date of the claimed invention, it would have been obvious to experiment with the positioning and size of the through-holes added to the Lui device. Godfrey and Laurenson teach that differently-sized and oriented through-holes will deliver gases to a culture medium at different rates and concentrations, and that the density and diameter of the through-holes may be optimized according to the needs of a particular operation.
With respect to claim 16, Lui, Wolf and Laurenson disclose the combination as described above, however do not teach that the medium chamber is provided with structures imposing a desired flow behavior to the medium flowing therethrough.
Godfrey discloses the apparatus as described above. Godfrey further states in paragraphs [0075] and [0120] that the medium chamber may include structures in the form of baffles to impose a desired flow behavior on the medium (“A mixing element or liquid agitator may also be employed in the chamber to mix the liquid contents, e.g., a impeller-type mixer, stir bar, and the like” and “Inside the bioreactor was an agitator with impellers that are used in combination with tank sidewall baffle”).
Before the effective filing date of the claimed invention, it would have been obvious to provide flow-modifying structures within the medium chamber of Liu. As evidenced by Godfrey, mixers and baffles are notoriously well known in the art, and would promote mixing and aeration when utilized in the Liu medium chamber. Those of ordinary skill would recognize that baffles in the Liu medium chamber would fulfill a similar effect as the structures 219 taught by Liu to modify gas flow in the gas chamber, and therefore would be characterized by a highly predictable operation.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Liu (US 20230092138) in view of Wolf (US 5707869) and Laurenson (US 5153137) as applied to claim 1, and further in view of Brau (US 20150118753).
Lui, Wolf and Laurenson disclose the combination as described above, however do not expressly state that a nozzle is inserted into the gas inlet port.
Brau discloses a sparging device comprising a gas inlet port (Figure 4:94) in communication with a nozzle (Figure 4:132). Fluid flows through the nozzle to the gas inlet port in order to deliver oxygen to a cell culture medium. This is taught in paragraphs [0052]-[0055].
Before the effective filing date of the claimed invention, it would have been obvious to deliver gas to Liu’s gas inlet port using a nozzle. As shown by Brau, this is an effective way to transfer an oxygenated gas into a cell culture medium. More specifically, Brau shows how the structure and position of the nozzle can be varied in order to adjust the flow properties of the delivered gas as needed during the course of the cell culture operation.
Claims 15 and 24 rejected under 35 U.S.C. 103 as being unpatentable over Pakdaman (US 20060244160) in view of Zipperian (US 4735709).
With respect to claim 24, Pakdaman discloses a sparging device for use in a bioprocess comprising a medium chamber (Figure 13:21) having a medium inlet opening (Figure 13:25) and a medium outlet opening (Figure 13:26) and at least one gas chamber (Figure 13:35). At least one gas inlet port (Figure 13:31) opens into the gas chamber for inflow of gas. The medium inlet opening and the medium outlet opening are located at different ends of the medium chamber, and the gas inlet port is located between the different ends. Furthermore, an inlet connecting piece (Figure 12:22) formed at the medium inlet opening and an outlet connecting piece (Figure 12:23) formed at the medium outlet opening are provided. This is described in paragraphs [0073]-[0084]. Pakdaman shows in at least Fig. 13 that the medium chamber at least partially surrounds the gas chamber. The medium chamber and the gas chamber are separated from each other by a wall (Figure 13:34) composed of porous material. Pakdaman, however, does not expressly state that the wall is a porous membrane or a porous ceramic.
Zipperian discloses a sparging device for use in a bioprocess comprising a medium chamber (Figure 1:17) having a medium inlet opening (Figure 1:20) and a medium outlet opening (Figure 1:29) and at least one gas chamber (Figure 1:71,72). At least one gas inlet port (Figure 1:76) opens into the gas chamber for inflow of gas. The medium inlet opening and the medium outlet opening are located at different ends of the medium chamber, and the gas inlet port is located between the different ends. This is described in column 6, line 24 to column 7, line 13. Zipperian teaches that the medium chamber at least partially surrounds the gas chamber, and that the medium chamber and the gas chamber are separated from each other by a wall comprising a porous membrane or a porous ceramic (“The construction of spargers is well-known in the art and several types may be used with good results…materials for spargers or micro-diffusers are porous plastics, fabrics, ceramics and rubber”). See also Fig. 4.
Before the effective filing date of the claimed invention, it would have been obvious to ensure that the Pakdaman medium chamber and gas chamber are separated using a porous membrane or porous ceramic. Zipperian indicates that porous membranes and porous ceramics are typically used in sparging devices to aerate a bulk medium in a known and predictable manner. Zipperian states that the pore size of a porous membrane or porous ceramic may be optimized in order to produce a desired bubble size and to reduce clogging.
With respect to claim 15, Pakdaman and Zipperian disclose the combination as described above. Pakdaman shows in at least Fig. 13 that a channel of the gas inlet port extends through an outer wall surrounding the medium chamber and through the medium chamber and opens into the gas chamber. Zipperian shows a similar configuration in at least Fig. 1.
Claims 18-21 are rejected under 35 U.S.C. 103 as being unpatentable over Pakdaman (US 20060244160) in view of Zipperian (US 4735709) as applied to claim 24, and further in view of Whalen (US 5634892).
Pakdaman and Zipperian disclose the combination as described above. Pakdaman teaches additional embodiments in which a further gas chamber surrounds the medium chamber. See Figs. 5-7 and paragraphs [0069]-[0071]. Pakdaman also states that gas is delivered to the medium chamber through a permeable outer wall (Figure 9:30) in other embodiments. It is unclear, however, if the different embodiments of Pakdaman are combined to produce an example in which the medium chamber surrounds a first gas chamber and a further gas chamber surrounds the medium chamber.
Whalen discloses a sparging device comprising a medium chamber (Figure 1:45) and a first gas chamber (Figure 1:120). The medium chamber at least partially surrounds the first gas chamber. The medium chamber and the first gas chamber are separated from each other by a wall (Figure 2:50a) made from a porous material, and the sparging device includes at least one gas inlet port (Figure 1:115) opening into the gas chamber. A second gas chamber (Figure 1:130) at least partially surrounds the medium chamber and is separated from the medium chamber via an outer wall (Figure 2:55a) that is also made from a porous material. This is taught in column 5, line 45 to column 6, line 5.
Before the effective filing date of the claimed invention, it would have been obvious to combine the different embodiments of Pakdaman to deliver gas into the medium chamber using a first gas chamber and a further gas chamber, such that the medium chamber is disposed between the multiple gas chambers. Whalen expressly shows how first and second gas chamber may be used to deliver air to fluid through separate permeable wall in a predictable manner. It would have been obvious to supply gas using a common inlet port that is split to deliver gas to both inlet lines, as this would have reduced the complexity of design by only requiring a single gas pump, for example. Those of ordinary skill would have known how to combine, split and recombine fluid/gas streams using common and available connector parts.
Response to Arguments
In response to the amendment filed 29 April 2026, the previous rejection under 35 U.S.C. 112 has been withdrawn.
In response to the amendment filed 29 April 2026, the previous rejections under 35 U.S.C. 102 have been withdrawn.
Applicant's arguments filed 29 April 2026 regarding the 35 U.S.C. 103 rejection of claim 1 have been fully considered but they are not persuasive. Applicant argues that Wolf is directed to static cell culture and therefore is fundamentally different than the continuous flow gas distributor of Liu. Although it is true that Liu teaches continuous flow and Wolf teaches static culture conditions, the references are not fundamentally different, but instead share the requirement for oxygenation through a membrane structure. Wolf is cited specifically for teaching that a porous gas exchange membrane should be supported by a wall structure having a plurality of through-holes. Wolf states that this imparts additional structural strength to the permeable membrane feature, which may otherwise be too thin and susceptible to damage and/or displacement. This teaching is applicable to essentially any gas exchange system, regardless of whether it is batch or continuous flow, and is especially relevant to Liu because Liu already teaches a similar configuration where a membrane supported by a rigid element is used to separate a gas chamber from a medium chamber.
Conclusion
This is a non-final rejection.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The Frankel (US 10633267) device teaches the state of the art regarding sparging systems.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATHAN ANDREW BOWERS whose telephone number is (571)272-8613. The examiner can normally be reached M-F 7am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Marcheschi can be reached at (571) 272-1374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NATHAN A BOWERS/ Primary Examiner, Art Unit 1799
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