DETAILED ACTION
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.
Claims 15 and 18-21 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Independent claim 1 requires that the sparging device is configured with the “gas chamber at least partially surrounding the medium chamber”. This is in conflict with the limitations in dependent claims 15 and 18-21 which require that “the medium chamber at least partially surrounds the gas chamber”. Although Fig. 10 shows an embodiment in which two separate gas chambers are provided, there does not appear to be a description of an embodiment where the same gas chamber both surrounds the medium chamber and is, in turn, surrounded by the medium chamber. This contradiction renders claims 15 and 18-21 indefinite as it is unclear what the placement of the gas chamber must be relative to the medium chamber.
Claim Rejections - 35 USC § 102
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim 24 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Whalen (US 5634892).
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 membrane, and the sparging device includes at least one gas inlet port (Figure 1:115) opening into the gas chamber. This is taught in column 5, line 45 to column 6, line 5.
Claim 24 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Васильевич (RU 162450)1.
Васильевич discloses a sparging device (Figure 1:1) comprising a medium chamber and a first gas chamber. 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 1:2) made from a membrane (“As a porous element, a membrane made of a polymeric, preferably hydrophobic, material is used”), and the sparging device includes at least one gas inlet port (Figure 1:5) opening into the gas chamber (“The device operates as follows. Purified water is supplied to the housing 1 through pipeline 3, and air through pipeline 5. Air passing through the pores of the porous element 2 enters the stream of water entering the saturator, directed perpendicular to the axis of the saturator. Moreover, as a result of the vortex flow around the tubular porous element 2, turbulence is created in the jet and the mass transfer efficiency in the water-air system increases. Treated water with microbubbles of air is discharged through line 4, and excess air is discharged through line 6”).
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).
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.
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 and Wolf 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 shows how it is desirable to support the membrane over a wall having through-holes formed therethrough. Wolf 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, Liu and Wolf 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, Liu and Wolf 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, Liu and Wolf 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, Liu and Wolf 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, Liu and Wolf 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, Liu and Wolf 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, Liu and Wolf 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, Liu and Wolf 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) as applied to claim 1, and further in view of Godfrey (US 20060033222).
With respect to claims 7 and 10, Liu and Wolf disclose the combination as described above, however do 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.
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 teaches 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, Liu and Wolf 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) as applied to claim 1, and further in view of Brau (US 20150118753).
Liu and Wolf 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.
Response to Arguments
In response to Applicant’s amendment filed 13 February 2026, the previous rejections have been withdrawn. However, upon further consideration, updated and new grounds of rejection have been made.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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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/NATHAN A BOWERS/ Primary Examiner, Art Unit 1799
1 See provided English translation