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 .
Status of Claims
Claims 1-10 and 49-59 are pending.
Claims 4-10 are withdrawn.
Claims 1-3 and 49-59 are rejected.
Further, it is noted that the application does not contain a Claim 53.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1, line 4 uses an improper Markush language (See MPEP 2173.05(h)). A Markush grouping is a closed group of alternatives, i.e., the selection is made from a group "consisting of" (rather than "comprising" or "including") the alternative members.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 50-52 and 56-58 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding Claim 50, it is unclear how a portion of the fixed bed can be located in a different location than the fixed bed itself. A portion of the fixed bed is required to be a part of the fixed bed. Further clarification and correction is required.
Regarding Claim 51, it is unclear how a portion of the fixed bed can comprise a discrete piece external to the bioreactor, since the fixed bed is a part of the bioreactor. Further clarification and correction is required.
Claim 52 is further rejected as it depends from Claim 51.
Regarding Claim 56, it is unclear how a portion of the fixed bed can be located in a different location than the fixed bed itself. A portion of the fixed bed is required to be a part of the fixed bed. Further clarification and correction is required.
Regarding Claim 57, it is unclear how a portion of the fixed bed can comprise a discrete piece external to the bioreactor, since the fixed bed is a part of the bioreactor. Further clarification and correction is required.
Claim 58 is further rejected as it depends from Claim 57.
Claim Rejections - 35 USC § 102
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, 2, and 49 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mairesse et al. (CA3106661A1).
Regarding Claim 1, Mairesse teaches the following:
A fixed bed perfusion bioreactor (page 9, lines 13-14)(an apparatus for culturing cells comprising a bioreactor including a fixed bed for culturing cells)
The bioreactor can contain sensors for monitoring different parameters including a cell density sensor (page 16, lines 34-38)(a sensor system for sensing a cell density of at least a portion of the fixed bed)
The cell density can be determined by electrical impedance analysis… using an arrangement of measuring electrode (page 17, lines 6-8)(a sensor for measuring impedance across at least a portion of the fixed bed)
Regarding Claim 2, Mairesse teaches all of the limitations of Claim 1 (see above). Mairesse further teaches the cell density to be determined by electrical impedance analysis (page 17, lines 6-8). The sensor must measure the impedance across some portion of the fixed bed in order to be able to measure the impedance. Further, Mairesse does teach the sensors can be in any compartment of the bioreactor (page 16, lines 35-36). Therefore the limitations of Claim 2 are met.
Regarding Claim 49, Mairesse teaches all of the limitations of Claim 1 (see above). The portion of the fixed bed must be located in a common chamber with the fixed bed as it is a portion of the fixed bed. Therefore Mairesse teaches all of the limitations of Claim 49.
Claims 1-3, 49, 54, and 55 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Castillo et al. (GB2465282A).
Regarding Claim 1, Castillo teaches the following:
A culture device with a fixed bed bioreactor (page 2, lines 23-24)(an apparatus for culturing cells comprising a bioreactor including a fixed bed for culturing cells)
A sensor containing an electrode arrangement to measure culture parameters especially biomass (cell density)(page 6, lines 18-20)(a sensor system for sensing a cell density of at least a portion of the fixed bed)
The cell density is determined by electrical impedance analysis (page 6, lines 25-26)(a sensor for measuring impedance across at least a portion of the fixed bed)
Regarding Claim 2, Castillo teaches all of the limitations of Claim 1 (see above). Castillo further teaches the cell density is determined by electrical impedance analysis (page 6, lines 25-26)(the sensor system comprises the sensor for measuring impedance across at least a portion of the fixed bed). The sensor must measure the impedance across some portion of the fixed bed in order to be able to measure the impedance. Therefore the limitations of Claim 2 are met.
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Regarding Claim 3, Castillo teaches all of the limitations of Claim 2 (see above). Castillo further teaches the electrical impedance analysis is done using an electrode arrangement of at least four measuring electrodes (pair of electrodes)(page 6, lines 26-28) and as seen in Fig. 7, below, the sensor element containing the electrodes are arranged with a portion of the fixed bed positioned between. Note: Castillo teaches the particular features, structures or characteristics may be combined in any suitable manner in one or more embodiments
Regarding Claim 49, Castillo teaches all of the limitations of Claim 1 (see above). The portion of the fixed bed must be located in a common chamber with the fixed bed as it is a portion of the fixed bed. Therefore Castillo teaches all of the limitations of Claim 49.
Regarding Claim 54, Castillo teaches the following:
A culture device with a fixed bed bioreactor (page 2, lines 23-24)(an apparatus for culturing cells comprising a bioreactor including a fixed bed for culturing cells)
A sensor containing an electrode arrangement to measure culture parameters especially biomass (cell density) with an arrangement of at least four electrodes (page 6, lines 18-21)(a sensor system for sensing a cell density of at least a portion of the fixed bed, the sensor system comprising a pair of electrodes) and as seen in Fig. 7, above, the sensor element containing the electrodes are arranged with a portion of the fixed bed positioned between.
Regarding Claim 55, Castillo teaches all of the limitations of Claim 54 (see above). The portion of the fixed bed must be located in a common chamber with the fixed bed as it is a portion of the fixed bed. Therefore Castillo teaches all of the limitations of Claim 55.
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 59 is rejected under 35 U.S.C. 103 as being unpatentable over Castillo et al. (GB2465282A) in view of Mairesse et al. (CA3106661A1).
Castillo teaches all of the limitations of Claim 55 (see above). Castillo does not explicitly teach the fixed bed to comprise a spiral bed. Mairesse teaches each bed to comprise a spiral bed (page 32, line 13).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Castillo with the spiral bed as taught by Mairesse. One would have been motivated to make this modification as it would help retain the cells being grown (page 32, line 14). Further, it would have been an obvious selection for the purposes of growing cell culture in a fixed bed and a selection based on its suitability for its intended purpose has been held prima facie obvious. See MPEP 2144.07.
Response to Arguments
Applicant's arguments filed 04/03/2026 have been fully considered but they are not persuasive.
Regarding Applicant’s arguments on page 1 disputing the 112(b) rejection. It is the examiners position that a portion of the claimed fixed bed cannot be located in a different location than the claimed fixed bed. Applicant draws the example of the fixed bed 122 and the auxiliary fixed bed which are in different chambers. This example does not apply to the current rejection as a fixed bed and an auxiliary fixed bed are individual structures not associated with one another and can be located in different sections.
Regarding Applicant’s arguments on page 2 that Mairesse does not teach sensing the cell density of at least a portion of the fixed bed nor measuring impedance across at least a portion of the fixed bed, Mairesse teaches the bioreactor can contain sensors for monitoring different parameters including a cell density sensor (page 16, lines 34-38). The sensor would necessarily read on some portion of the fixed bed. Mairesse further teaches the cell density can be determined by electrical impedance analysis (measuring impedance)… using an arrangement of measuring electrode (page 17, lines 6-8), like above, this would necessarily be determined across some portion of the fixed bed.
Regarding Applicant’s arguments on page 2-3 that Mairesse does not disclose the electrodes arranged to span a portion of the fixed bed, as Applicant states, Mairesse teaches the sensors may be located in any compartment of the bioreactor which is the location of the fixed bed as taught by Mairesse.
Regarding Applicant’s arguments on page 3 that Castillo does not teach a pair of electrodes arranged with the portion of the fixed bed positioned therebetween, Castillo teaches the electrical impedance analysis is done using an electrode arrangement of at least four measuring electrodes (pair of electrodes)(page 6, lines 26-28). These electrodes are on opposite ends of the fixed bed (see Fig. 7, above).
In response to applicant's argument that swapping in Mairesse’s spiral module would alter Castillo’s ability to measure impedance, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). One of ordinary skill in the art would be able use the teaching of the spiral configuration and incorporate it into the device of Castillo to arrive at the claimed invention for the reasons provided above absent clear evidence to the contrary.
Conclusion
THIS ACTION IS MADE FINAL. 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 JONATHAN E LEPAGE whose telephone number is (571)270-3971. The examiner can normally be reached 8:30-5:30 ET.
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/J.E.L./ Examiner, Art Unit 1796
/MICHAEL A MARCHESCHI/ Supervisory Patent Examiner, Art Unit 1799
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