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 .
Claim Interpretation
It is noted that the specification defines the term “UV-sterilizable” in [0073] and the term “UV-transparent” in [0083].
Response to Amendment
In light of the amendment filed 8 May 2026, the objection to the drawings has been withdrawn and the prior art rejection has been slightly modified.
The declaration under 37 CFR 1.132 filed 8 May 2026 is insufficient to overcome the rejection of the claims based upon De as set forth in the last Office action because: the declaration states that “I do not understand De to disclose such UV-transmissive structures or irradiation geometry” in order to internally sterilize the bioreactor with UV radiation. However, it is noted that De explicitly teaches that that the vessel 202 can be transparent and that the “assembled perfusion bioreactor can be […] ultra-violet (UV) sterilized.” Such a teaching would necessitate that the vessel is either UV transmissive, which transparent and UV-transmissive materials are extremely well known and understood in the art, or that the UV radiation is applied at a large enough power to effectively sterilize the interior of the vessel. It is noted that claim 1 has not been limited to recite the composition of the chamber walls, wherein all of the interior surfaces are sterilized, or the irradiation geometry of the chamber or component. It is also held that one of ordinary skill in the art would reasonably read that the interior surfaces of the bioreactor of De are sterilized and would have been capable of determining how to construct the chamber in order to allow UV irradiation to penetrate therein as all the other recited modes of sterilization would be used to sterilize internal surfaces. It simply remains the disclosure of De that the “assembled perfusion bioreactor can be […] ultra-violet (UV) sterilized” must mean that at least one interior surface is capable of being sterilized while the chamber maintains a sterile boundary with the environment due to the bioreactor being “assembled.” The mere absence of explicit teaching of UV-transmissive materials being used to form the transparent vessel is not viewed to be a burdensome “workflow” as argued in the declaration as such materials are extremely well known in the art and are used to form other components of the bioreactor as noted in the rejection below. Further, claim 1 does not limit the materials of the chamber walls.
Response to Arguments
Applicant's arguments filed 8 May 2026 have been fully considered but they are not persuasive.
Applicant argues that the McAuliffe Declaration shows that a person of ordinary skill in bioreactor design and operation would not understand the statement of De at paragraph [0036] to disclose “one or more UV light sources are configured to expose said ultraviolet light to said surfaces within said chamber while said chamber maintains a sterile boundary with the environment” as limited in claim 1. The Examiner respectfully disagrees. The Examiner has noted above how the McAuliffe Declaration fails to overcome the prior art rejection and will not repeat the arguments for purpose of brevity.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 3-15, 20-23, 26-28 and 30-39 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by De et al. (WO 2017/146928; hereinafter “De”).
In regard to claim 1, De discloses a UV-sterilizable bioreactor system (perfusion bioreactor 200) comprising: (a) a chamber (vessel 202) configured to carry out a reaction; (b) a component (gas sparger 244 or porous membrane 206) configured for introducing a gas into said chamber; and (c) one or more UV light sources (necessitated by the teaching that the “assembled perfusion bioreactor can be […] ultra-violet (UV) sterilized” in [0036]) configured to expose ultraviolet light to surfaces within said chamber, wherein said one or more UV light sources are configured to expose said ultraviolet light to said surfaces within said chamber while said chamber maintains a sterile boundary (with use of the lid 204) as necessitated by the teaching that the “assembled perfusion bioreactor can be […] ultra-violet (UV) sterilized” (emphasis added) in [0036]. See Figures 2-4 and paragraphs [0026], [0028] and [0036].
In regard to claim 3, De discloses wherein said component is a gas sparger 244. See [0028].
In regard to claim 4, De discloses wherein said component is a membrane 206 which is necessarily capable of having gas transported therethrough, as it is disclosed to be “semi-permeable,” which is received from gas sparger port 236 as the gas sparger can have an end 245 in the outer compartment 220. See Figure 4, [0026]-[0028] and [0030].
In regard to claim 5, De discloses wherein said component is necessarily UV-sterilizable as the assembled perfusion bioreactor is taught to be capable of being sterilized by UV light which would necessarily include all components of the bioreactor. See [0036].
In regard to claims 6-9, De discloses wherein said component contains a UV-transparent material as the porous membrane 206 can be formed of plastics (recited in claim 7) such as polytetrafluoroethylene (recited in claim 9) which is a fluoropolymer (recited in claim 8), ceramic (recited in claim 7) or glass (recited in claim 7). See paragraph [0027] and Figures 2-4.
In regard to claim 10, De does not explicitly disclose wherein said UV-transparent ceramic is selected from the group consisting of quartz, fused silica, borosilicates, and combinations thereof. However, it is noted that the broadest reasonable interpretation of the claim does not include wherein said UV-transparent material is selected to be a ceramic as claim 7 includes other optional materials. Thus, the claim is merely further defining the composition of the ceramic while the broadest reasonable interpretation of the claim is met by the recited composition of polytetrafluorethylene. See [0027].
In regard to claims 11-13, it is noted that the limitations reciting the composition of the gas which is introduced into the chamber is not further limiting. The Courts have held that “[e]xpressions relating the apparatus to contents thereof during an intended operation are of no significance in determining patentability of the apparatus claim.” Ex parte Thibault, 164 USPQ 666, 667 (Bd. App. 1969). Furthermore, “[i]nclusion of material or article worked upon by a structure being claimed does not impart patentability to the claims.” See In re Young, 75 F.2d *>996<, 25 USPQ 69 (CCPA 1935) (as restated in In re Otto, 312 F.2d 937, 136 USPQ 458, 459 (CCPA 1963)) (see MPEP § 2115). Therefore, as the gas sparger 244 is capable of introducing air, oxygen, syngas, hydrogen, carbon monoxide, methane, natural gas, or a combination thereof into the chamber, the claims are anticipated by the disclosure of De. The Courts have held that if the prior art structure is capable of performing the intended use, then it meets the claim. See In re Casey, 152 USPQ 235 (CCPA 1967); and In re Otto, 136 USPQ 458, 459 (CCPA 1963).
In regard to claim 14, De discloses wherein said UV-sterilizable bioreactor system further comprises one or more conduits (fresh media tube 224, spend media tube 228 and bleed-off tube 250) configured to feed an input material into said chamber and/or to withdraw an output material out of said chamber. See Figures 2-4 and [0028].
In regard to claim 15, De necessarily discloses wherein at least one of said one or more conduits is UV-sterilizable as it is taught that the “assembled perfusion bioreactor can be […] ultra-violet (UV) sterilized” in [0036].
In regard to claim 20-21, De discloses wherein at least some, as claimed in claim 20, or all, as claimed in claim 21, of said one or more UV light sources are external to said chamber as the UV light source(s) must be external as no internal light source is disclosed. As noted above, De teaches that the “assembled perfusion bioreactor can be […] ultra-violet (UV) sterilized” in [0036].
In regard to claim 22, De discloses wherein said chamber (vessel 202) has walls fabricated from a metal, a metal alloy (stainless steel is a metal and a metal alloy), a polymer (“plastic”), a ceramic, or glass in [0026].
In regard to claim 23, De discloses wherein said chamber (transparent vessel 202; [0026]) has UV-transparent chamber walls containing a UV-transparent material as necessary to enable the “assembled perfusion bioreactor [to] be […] ultra-violet (UV) sterilized” as recited in [0036].
In regard to claim 26, De necessarily discloses wherein said one or more UV light sources are configured to expose ultraviolet light to at least 80% of total surface area as recited within said chamber including its internal components as recited in claim 26 and wherein said one or more UV light sources are configured to expose ultraviolet light to at least 80% of total volume of said chamber as recited in claim 27. It is noted that De discloses that the “assembled perfusion bioreactor can be […] ultra-violet (UV) sterilized” in [0036] which means that the entire assembled perfusion bioreactor can be sterilized which means a 6 log reduction of pathogens as known to one of ordinary skill in the art.
In regard to claim 28, De necessarily discloses wherein said one or more UV light sources each have a UV wavelength selected from about 100 nm to about 400 nm as the entire spectrum of UV light is defined as light having a wavelength between 100 nm and 400 nm as understood by one of ordinary skill in the art. It is noted that De discloses that the “assembled perfusion bioreactor can be […] ultra-violet (UV) sterilized” in [0036] which necessitates the use of a wavelength between 100 nm and 400 nm.
In regard to claim 30, De discloses wherein said bioreactor system contains an impeller (mixing device 212 can be in the form of an impeller 232) situated within said chamber, and wherein said impeller is necessarily UV-sterilizable as De discloses that the “assembled perfusion bioreactor can be […] ultra-violet (UV) sterilized” in [0036]. See Figures 2-4 and [0026]-[0028].
In regard to claim 31, De discloses wherein said chamber does not contain an impeller as the mixing device 212 can alternatively be a “levitating stir element, a magnetic stir element, [or] a paddlelike stirring element” and further teaches that “any suitable stirring devices” can be used. See [0028].
In regard to claim 32, De discloses wherein said UV-sterilizable bioreactor system further comprises a filtration unit (spin filter 243 or porous membrane 206) configured to filter an input material before being fed into said chamber (vessel 202) by passing through the membrane 206. See [0026] and [0030].
In regard to claim 33, De discloses wherein said filtration unit (spin filter 243 or porous membrane 206) is UV-sterilizable as De discloses that the “assembled perfusion bioreactor can be […] ultra-violet (UV) sterilized” in [0036].
In regard to claim 34, De discloses wherein said UV-sterilizable bioreactor system contains a bioreactor sensor (sensor 254) situated within said chamber, and wherein said bioreactor sensor is necessarily UV-sterilizable as De discloses that the “assembled perfusion bioreactor can be […] ultra-violet (UV) sterilized” in [0036]. See Figures 3-4 and paragraphs [0028]-[0031].
In regard to claim 35, De discloses wherein said bioreactor sensor is configured to detect or measure a bioreactor parameter selected from the group consisting of pH, temperature, oxygen (DO2), carbon dioxide (CO2), or cell density. See [0029].
In regard to claim 36, De discloses wherein said bioreactor sensor is necessarily contained in a UV-sterilizable housing in order to maintain operation of the sensor that is situated within said chamber as De teaches that as sensors can be to one or both of the inner and other compartments. De discloses that the “assembled perfusion bioreactor can be […] ultra-violet (UV) sterilized” in [0036]. Thus, the sensor would necessarily be UV-sterilizable as it is a component of the assembled perfusion bioreactor.
In regard to claim 37, De discloses wherein said bioreactor sensor is disposed within or through a probe port (sensor port 240), and wherein said probe port is necessarily UV-sterilizable as De discloses that the “assembled perfusion bioreactor can be […] ultra-violet (UV) sterilized” in [0036].
In regard to claim 38, De discloses wherein said bioreactor system contains a clean-in-place arm (membrane clearing blade 258 attached to the shaft 234) situated within said chamber. See [0031].
In regard to claim 39, De discloses wherein said clean-in-place arm (membrane clearing blade 258 attached to the shaft 234) is necessarily UV-sterilizable as De discloses that the “assembled perfusion bioreactor can be […] ultra-violet (UV) sterilized” in [0036].
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 16-19, 24 and 29 are rejected under 35 U.S.C. 103 as being unpatentable over De in view of Havens et al. (US 2008/0265179; hereinafter “Havens”).
In regard to claim 16-19 and 29, De is silent to wherein said one or more UV light sources are situated within said chamber as recited in claim 16, to wherein said one or more UV light sources are situated within UV-transparent wells that are disposed within said chamber as recited in claim 17, to wherein said one or more UV light sources are permanently situated within said chamber as recited in claim 18, to wherein said one or more UV light sources are reversibly situated within said chamber and to wherein said one or more UV light sources are selected from the group consisting of UV light-emitting diodes, UV mercury lamps, UV xenon lamps, and UV krypton lamps as recited in claim 29.
Havens discloses a sterilization apparatus 100 wherein the entire internal area of a sterilization chamber is irradiated by ultraviolet light emitting diodes (UVLEDs 105) to destroy biological materials to achieve an efficient level of sterilization. The UVLEDs 105 can be viewed to necessarily be within UV-transparent wells within the chamber as the UVLEDs are arranged on the inside surfaces of the top wall 101, bottom wall 102, end walls 103, side walls 104 and hinged door 109. It is viewed that the UVLEDS of the top wall 101, bottom wall 102, end walls 103 and side walls 104 are permanently situated within the chamber and the UVLEDS on the hinged door 109 are reversable situated within the chamber as the door can be opened away from the chamber. Havens teaches that the invention can be used in manufacturing facilities, packaging facilities, food and pharmacological plants or any research and development laboratory facility. See Figure 1 and [0024]-[0031].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the UVLEDs on the internal surfaces of a chamber as disclosed by Havens with the UV-sterilizable bioreactor of De for the purpose of providing UV light sources with the bioreactor for the purpose of sterilizing the entire assembled bioreactor. Applying a known technique to a known device (method or product) ready for improvement to yield predictable results is likely to be obvious. See KSR International Co. v. Teleflex Inc., 550 U.S. __,__, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, D.). The combination of familiar elements is likely to be obvious when it does no more than yield predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. __,__, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, A.). It is noted that the recited “reversibly situated” light sources would be situated on the removable lid 204 of the apparatus of De.
In regard to claim 24, De is silent to wherein said chamber has UV-reflective chamber walls containing, or internally coated with, a UV-reflective material.
Havens discloses wherein the interior surfaces of walls 101, 102, 103 and 104 of the chamber can include a UV reflective material such as polished aluminum to reflect the UV light from the interior UVLEDs. See [0028].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the UV reflective material of Havens with the bioreactor of De for the purpose of internally reflecting light from UVLEDs situated within the chamber. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. __,__, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, A.). Applying a known technique to a known device (method or product) ready for improvement to yield predictable results is likely to be obvious. See KSR International Co. v. Teleflex Inc., 550 U.S. __,__, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, D.).
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 TIMOTHY C CLEVELAND whose telephone number is (571)270-5041. The examiner can normally be reached M-F 9:00-5:30.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Claire Wang can be reached at (571) 270-1051. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TIMOTHY C CLEVELAND/Primary Examiner, Art Unit 1774
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