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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 02/06/2026 has been entered.
Claim Rejections - 35 USC § 103
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 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.
Claim(s) 1-9 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jones et al. US 201600096131 in view of Pitt et al. US 5,094,675.
For claim 1 the Jones et al. reference discloses a method for removing exhaust gas from a bioreactor (par 005) including the steps of providing at least one exhaust filter (74) connected to an outlet (65) of the bioreactor for transferring exhaust gas out from the bioreactor and increasing a pressure at an outlet side of the at least one exhaust filter, thereby increasing a pressure differential across the at least one exhaust filter (paragraph 0062, 0063 “one option is to increase the gas pressure on the upstream side of filter 74”, “casing 70… safely withstanding higher gas pressures” ).
The reference does not disclose using a pressure controlling device provided upstream of the exhaust filter.
The Pitt et al. reference is also related to creating pressure differences across a filter element and discloses a pressure controlling device provided upstream of the exhaust filter (Pitt et al. column 4 lines 46-53).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the Jones et al. reference to include a pressure controlling device provided upstream of the exhaust filter (Pitt et al. column 4 lines 46-53) as the location of the pressure inducing source is of no consequence as long as there is the pressure differential across the filtration element. Further the courts have held that that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
Regarding to claim 3, Jones et al teach the step of providing a pressure controlling device (185, paragraph 0066-0068) such as applying a partial vacuum or negative pressure to the exhaust port (65) of filter (74) so that the applied pressure increases the flow rate of gas through the filter (74f) and increasing a pressure differential across the at least one exhaust filter (paragraph 0065). To note by decreasing a pressure at an outlet side of the at least one exhaust filter this would increase the pressure at the inlet side of the at least one exhaust filter.
Regarding to claim 4, Jones et al further teach the steps of measuring the pressure in the bioreactor (paragraph 0069) via a pressure gauge (189), controlling the pressure controlling device (185) to provide different amount of pressure decrease to the outlet side of the at least one exhaust filter (74) or pressure increase to the inlet side of the at least one exhaust filter (74) in dependence of the measured pressure in the bioreactor (see paragraphs 0066-0070).
Regarding to claim 5, Jones et al teach the bioreactor comprising a flexible bioreactor bag (paragraphs 0007 & 0031).
Regarding to claim 6, Jones et al teach the bioreactor being a single-use bioreactor (paragraph 0029).
Regarding to claim 7, Jones et al further teach the step of providing gas into the bioreactor through an inlet filter (74A, paragraphs 0046-0048).
Regarding to claim 8, Jones et al further teach the steps of providing first and second filters (66C, 66D, 66E in Fig. 5) connected in parallel via one valve (220A, 220B,220C in Fig. 5) and connecting first the first filter through the outlet valve and when the first filter is clogged connect the second filter to the outlet via one valve (paragraph 0073).
Regarding to claim 9, Jones et al teach the pressure controlling device (185) being a pump or fan. As shown above, Pitt et al. discloses a fan.
Regarding to claim 19, Jones et al teach a control system configured for being connected to a pressure control device (185, paragraphs 0066-0068) in the bioreactor system configured to perform the method according to claim 8 wherein the control system (190) is configured to be connected to a pressure sensor (189, paragraph 0069) for measuring a pressure in the bioreactor and wherein the control system (190, paragraphs 0071 & 0072) comprises software for controlling the pressure controlling device (185) to provide different amount of pressure increase to the inlet side of the at least one exhaust filter (74) in dependence of the pressure measured by the pressure sensor (see paragraphs 0062-0065).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, 3-9 and 19 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
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AMBER ROSE ORLANDO
Primary Examiner
Art Unit 1731
/AMBER R ORLANDO/Primary Examiner, Art Unit 1731
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