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].
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the membrane component, UV-transparent wells disposed within the chamber for situating one or more UV light sources, UV-sterilizable filtration unit must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(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.
Claims 1-15, 20-23, 25-28 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. See Figures 2-4 and paragraphs [0026], [0028] and [0036].
In regard to claim 2, De discloses wherein said chamber is configured to maintain a sterile boundary (with use of the lid 204) with the environment as it is taught that sterile water and cells are added to the bioreactor in [0028]). Thus, the vessel 202 and lid 204 must necessarily be capable of maintaining a sterile boundary.
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 25, De discloses wherein said chamber is configured with a chamber top (lid 204; [0026]) that is capable of being not sealed from the environment as the lid can be removed, and wherein said chamber top is UV-sterilizable to form a sterile barrier with said environment as De disclose that the “assembled perfusion bioreactor can be […] ultra-violet (UV) sterilized” 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 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 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
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.
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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