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 .
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 2/6/2026 is acknowledged. Claims 11-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
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.
Claim(s) 1-6 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by United States Patent No. 5,188,962, hereinafter Hasegawa.
Regarding claim 1, Hasegawa teaches a media conditioning vessel (figure 1) for a perfusion bioreactor system (intended use MPEP § 2114 (II)), the media conditioning vessel comprising: a vessel (item 11) comprising an interior cavity (the inside of item 11) configured to hold a volume of liquid cell culture media (intended use MPEP § 2114 (II) and is taught in figure 1); a media inlet (item 56) configured to return cell culture media from a perfusion bioreactor to the vessel (figure 1); and a media outlet (item 40) configured to transfer cell culture media out of the vessel to the perfusion bioreactor (figure 1), wherein at least one of the media inlet and the media outlet comprises one or more inline sensors (items 43-55) configured to measure or detect a characteristic of the cell culture media (columns 3-4, lines 66-2).
Regarding claim 2, Hasegawa teaches wherein the one or more inline sensors comprises at least one of a dissolved oxygen sensor and a pH sensor (columns 3-4, lines 66-2).
Regarding claim 3, Hasegawa teaches further comprising a gas sparging tube (item 16) configured to sparge a gas in the interior cavity (figure 1).
Regarding claim 4, Hasegawa teaches further comprising a perfusion loop (the loop formed by items 40 and 50) comprising a pump (item 51) configured to pump cell culture media from the media outlet to a media return that returns cell culture media to the interior cavity (figure 1).
Regarding claim 5, Hasegawa teaches wherein the one or more inline sensors are disposed inline in the perfusion loop (figure 1).
Regarding claim 6, Hasegawa teaches further comprising a supply tube (the side of item 40 closer to item 42) configured to supply media to the perfusion bioreactor (figure 1), the supply tube being disposed between the media outlet and the one or more inline sensors in the perfusion loop (figure 1).
Claim(s) 1-3 and 9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by United States Application Publication No. 2007/0172945, hereinafter O’Kennedy.
Regarding claim 1, O’Kennedy teaches a media conditioning vessel (figure 1) for a perfusion bioreactor system (intended use MPEP § 2114 (II)), the media conditioning vessel comprising: a vessel (item 1) comprising an interior cavity (figure 1) configured to hold a volume of liquid cell culture media (figure 1); a media inlet (the piping attached where item 7 is) configured to return cell culture media from a perfusion bioreactor to the vessel (intended use MPEP § 2114 (II)); and a media outlet (the tubing which connects items 19-21) configured to transfer cell culture media out of the vessel to the perfusion bioreactor (intended use MPEP § 2114 (II)), wherein at least one of the media inlet and the media outlet comprises one or more inline sensors (items 19-21) configured to measure or detect a characteristic of the cell culture media (intended use MPEP § 2114 (II)).
Regarding claim 2, O’Kennedy teaches wherein the one or more inline sensors comprises at least one of a dissolved oxygen sensor, a pH sensor, and a temperature sensor (items 19-21).
Regarding claim 3, O’Kennedy teaches a gas sparging tube configured to sparge a gas in the interior cavity (item 9).
Regarding claim 9, O’Kennedy teaches an outer sparge tube (the outer tube shown in figure 3) disposed within the interior cavity (figure 1), wherein the media inlet comprises a tube (the tube labeled liquid entry side arm) within the interior cavity (figure 1), the tube being at least partially disposed within the outer sparge tube (figure 3), and wherein a gas inlet (the inner tube, labeled gas entry tube) is at least partially disposed within the outer sparge tube (figure 3).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 7 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hasegawa in view of United States Application Publication No. 2015/0093775, hereinafter Rao.
Regarding claim 7, Hasegawa teaches sensors (item 30) attached to a sidewall or a bottom of the media conditioning vessel (figure 1).
Hasegawa fails to teach the sensors are one or more of patch sensors.
Rao teaches an analyte sensing device in which patch sensors are utilized because they are usually disposable and are only partially invasive (Rao, paragraph [0079]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have changed the temperature sensor of Hasegawa to a patch sensor because the sensor would be disposable and are only partially invasive (Rao, paragraph [0079]).
Regarding claim 8, modified Hasegawa teaches wherein the one or more patch sensors comprises a temperature sensor (see supra).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over O’Kennedy in view of United States Application Publication No. 2006/0033222, hereinafter Godfrey.
Regarding claim 10, O’Kennedy teaches the outer sparge tube comprises a sidewall (figure 3).
O’Kennedy fails to teach the sidewall comprising a plurality of openings sized to prevent bubbles from within the outer sparge tube passing through the plurality of openings.
Godfrey teaches a device for introducing gas into a liquid in which the bottom side of the outer sparge tube has a plurality of sparge holes which produces bubbles having a specified mean diameter (Godfrey, paragraph [0047]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have added a plurality of openings in the sidewall of the outer sparge tube because the openings would produce bubbles having a specified mean diameter (Godfrey, paragraph [0047]).
Regarding the limitations the openings are sized to prevent bubbles from passing through the opening, these limitations are directed to the function of the apparatus and/or the manner of operating the apparatus, all the structural limitations of the claim has been disclosed by O’Kennedy and Godfrey and the apparatus of modified O’Kennedy is capable of some about of bubbles from passing through the openings as bubbles which are larger than the mean diameter would not pass through. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of modified O’Kennedy (see MPEP §2114).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW D KRCHA whose telephone number is (571)270-0386. The examiner can normally be reached M-Th 7am-5pm.
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/MATTHEW D KRCHA/Primary Examiner, Art Unit 1796