DETAILED ACTION
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, 5, 13-16, 18-22, 25, 28, 29, 31, 35 and 44-46 are rejected under 35 U.S.C. 103 as being unpatentable over Berti Perez (WO 2022029163) in view of Hei (US 5868859) and Heese (US 20190144811).
With respect 1, 18 and 31, Berti Perez discloses a foam identification system and method comprising the provision of a housing configured to support a vessel (e.g., bag). See Fig. 1. A thermal imaging camera (Figure 6:602) is secured to the housing (“The camera 602 may be a handheld camera or it can be mounted on a bioreactor or equipment (not shown)”, emphasis added), and is configured to image a surface of a liquid (Figure 6:612) and a foam (Figure 6:614) exposed to the headspace (Figure 6:616) of the vessel. This is described in paragraphs [0034]-[0038]. A controller (Figure 5:540) is operatively connected to the thermal imaging camera, and the camera and controller are configured to detect a change in temperature of the exposed surface to identify foam on the exposed surface (“the camera 602 can detect a temperature variance due to a foam 614. A foam 614 will not have the same temperature as a liquid 612 it is disposed upon. Typically, the foam 614 will be cooler”). The thermal imaging camera 602 is used to create a thermographic scale (Figure 6:628) that will indicate a difference in temperature between a surface of the liquid and of a foam exposed to the headspace. Foam is identified based on a detected change in temperature since Berti Perez teaches that foam will typically be colder than the culture fluid immediately underneath it. This optical step is conducted without illumination (Berti Perez does not appear to mention anywhere that the operation of the camera 602 involves illumination from an external light source). Although Berti Perez clearly recognizes that the liquid and foam are characterized by different temperatures, it is unclear if Berti Perez expressly detects a change in temperature of an exposed liquid surface.
Hei discloses a foam identification system and method in which a vessel (Figure 3:30) is in communication with a thermal imaging camera (Figure 3:38). The thermal imaging camera is configured to image a surface of a liquid (Figure 3:32) and foam (Figure 3:37) exposed to a headspace of the vessel. A controller is operatively connected to the thermal imaging camera and is configured to detect a change in temperature of the liquid surface based on the presence of foam. Column 10, line 62 to column 12, line 51 describes how changes in detected liquid surface temperature indicate that foam is present. This optical step is conducted without illumination (Hei does not appear to mention anywhere that the operation of the camera 602 involves illumination from an external light source).
Before the effective filing date of the claimed invention, it would have been obvious to ensure that the Berti Perez thermal imaging camera and controller are used and configured to identify foam on an exposed liquid surface based on a detected change in temperature. Hei shows in at least Figs. 4 and 6 how foams of increasing thickness will affect liquid surface temperature by increasing amounts, and that foam presence can be inferred from the magnitude of the detected change in temperature. Accordingly, Hei teaches that not only is foam presence detected, but also the magnitude of foam accumulation at any given location (“The defoamed aqueous medium had a surface temperature or emission of about 94°-97°F. The foam was permitted to accumulate to produce a foaming layer about 3-6 inches in depth. As the foaming layer increased, the apparent temperature of the surface of the aqueous medium insulated by the foam substantially dropped greater than 10°F. The temperature changes from about 96°F to about 84°F producing a surface difference of about 8°-15°F difference”).
Hei shows a configuration in which the camera 38 is mounted on a support structure so that it is positioned above the vessel and aimed vertically downward. It would have therefore been obvious to ensure that the Berti Perez camera is mounted on a support structure and aimed vertically downward so that substantially an entirety of the surface may be imaged. Berti Perez already teaches that “[t]he camera 602…can be mounted on…equipment” associated with the bioreactor, and Hei depicts how a camera will naturally be aimed downward to image an entire surface of the reactor. Those of ordinary skill would have recognized that this would allow the total foam condition to be evaluated all at once, which is more efficient than separately imaging different portions of the liquid surface.
Similarly, Heese shows that it is known in the art to mount a disposable container (Figure 1:2), such as a bag bioreactor, within a rigid housing (Figure 8:103) mounted atop a frame (Figure 8:102b). Heese shows that a support structure is located on the housing and opposite from the frame. The support structure includes a plurality of leg portions that allow equipment (Figure 8:109) to be mounted over and above the disposable container. This is taught in paragraphs [0094]-[0100].
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Heese teaches that the housing is useful because it includes a rigid body suitable for the attachment of a variety of pumps, valves, sensors, controllers, etc. that facilitate the operation of the bioreactor. Heese further states that the provision of support structure having a plurality of legs at the top of the housing is useful because it allows equipment (such as the cameras of Berti Perez and Hei) to be suspended over the bioreactor and in communication with the contents of the reactor.
With respect to claims 5, 22, 25 and 35, Berti Perez, Hei and Heese disclose the combination as described above. The thermographic scale 628 created by Berti Perez provides data that may be used to quantify a response of the foam to anti-foam agents. Similarly, Hei shows in Figs. 4 and 6 data that quantifies a response of the foam to anti-foam agents.
With respect to claim 13, Berti Perez, Hei and Heese disclose the combination as described above. As previously discussed, Berti Perez teaches a housing (Figure 1:102) configured to support the vessel. Alternatively, Berti Perez states in paragraphs [0013], [0017] and [0018] that the vessel may be a collapsible flexible bag supported by a housing structure.
With respect to claims 14-16, 19-21, 28, 29 and 44-46, Berti Perez, Hei and Heese disclose the combination as described above. The thermographic scale 628 created by Berti Perez provides data that may be used to identify the presence of foam by comparing a temperature of the liquid surface to a temperature of the liquid, a temperature of the headspace, and a temperature of the foam. Hei expressly teaches how temperature changes of the exposed liquid surface over time may be recorded, and how the rate of temperature change is used to assess foam presence and amount. See Fig. 4, for example, which shows a plurality of temperature measurements made over time to indicate the temperature rate of change caused by foam build-up.
Claims 2-4, 17, 23, 24, 32-34 and 47 are rejected under 35 U.S.C. 103 as being unpatentable over Berti Perez (WO 2022029163) in view of Hei (US 5868859) and Heese (US 20190144811) as applied to claims 1, 18 and 31, and further in view of Galliher (US 9908664).
Berti Perez, Hei and Heese disclose the combination as described above, however do not expressly teach a temperature control system comprising a gas temperature controller and monitor configured to control the temperature of the headspace.
Galliher discloses a foam identification system comprising a vessel in communication with a foam sensor (Figure 7:611). The vessel (Figure 1:10) may additionally include a temperature control system comprising a gas temperature controller and gas temperature monitor. The temperature control system, for example, may include a cooling means provided in the headspace. See column 13, lines 55-64.
Before the effective filing date of the claimed invention, it would have been obvious to control and monitor the temperature of the headspace gas within the Berti Perez vessel. Galliher states that headspace gas cooling can enhance condensate return to the vessel, which can reduce exit air filter plugging and fouling. As evidenced by Galliher, jacket cooling, electrothermal, chemical cooling and heat exchanger means are all typically used to cool and regulate headspace gas temperature in bioreactor systems.
Claims 6, 7, 26, 27, 36 and 37 are rejected under 35 U.S.C. 103 as being unpatentable over Berti Perez (WO 2022029163) in view of Hei (US 5868859) and Heese (US 20190144811) as applied to claims 1, 18 and 31, and further in view of Chamberlain (US 20060232675).
Berti Perez, Hei and Heese disclose the combination as described above, however do not expressly teach that the thermal imaging camera is radiometric and detects IR light having a wavelength from 7 to 14 microns.
Chamberlain discloses a general-purpose thermal imaging system. Chamberlain states in paragraphs [0005]-[0007] that radiometric thermal imaging cameras that detect IR light in the wavelength range of 7-14 microns are typically used.
Before the effective filing date of the claimed invention, it would have been obvious to use in the Berti Perez system a radiometric thermal imaging camera configured to detect IR light in the wavelength range of 7-14 microns. Chamberlain states that thermal imaging cameras that fit this description are well known across varying arts and that they are readily obtainable. It would have been within the ability of one of ordinary skill to choose a particular thermal imaging cameras from a selection of available functionally equivalent alternatives.
Claims 8-10, 30, 38-41 and 43 are rejected under 35 U.S.C. 103 as being unpatentable over Berti Perez (WO 2022029163) in view of Hei (US 5868859) and Heese (US 20190144811) as applied to claims 1, 18 and 31, and further in view of Canty (US 20180252692) and Hirano (US 20080000892).
Berti Perez, Hei and Heese disclose the combination as described above, however do not expressly state that the vessel has a view port that is heated to reduce condensation.
Canty discloses a foam identification system comprising a vessel (Figure 1:28) having a view port (Figure 1:36) in communication with a detector (Figure 5:22), such as an infrared detector. Canty teaches in paragraphs [0033]-[0034] that a thermal regulation system (Figure 5:48) is used to heat the view port and thereby reduce condensation.
Hirano discloses a biochemical assay vessel (Figure 41:20) in communication with a photodetector (Figure 41:300) via a transparent view port (Figure 41:112). Paragraphs [0211]-[0222] state that the view port is heated to reduce condensation. Paragraph [0239] teaches that this heating may be accomplished using a heated air curtain (Figure 75:2070).
Before the effective filing date of the claimed invention, it would have been obvious to provide the Berti Perez system and method with a heated view port configured to reduce condensation. Canty teaches that this improves the accuracy and quality of thermal imaging, and may be accomplished using standard thermoelectric devices. Canty teaches that the operation of the thermal regulation system may be automated to optimize thermal imaging conditions over the course of the cell culture operation. Hirano further teaches that heating of a view port may be accomplished using a heated convective gas (i.e., air curtain), and that this is equivalent to heating the view port using other types of heating means.
Response to Arguments
In response to Applicant’s amendment filed 10 March 2026, the previous rejections have been withdrawn. However, upon further consideration, a new ground of rejection is made in view of the combination of Berti Perez with Hei and Heese.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The Becker (US 20220235304) reference teaches the state of the art regarding rigid bioreactor housings having a frame and a support structure.
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