DETAILED ACTION
Claims 1-16 are pending.
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 .
Response to Arguments
Applicant’s arguments, filed 03/26/2026, have been fully considered but are not persuasive. Applicant’s arguments are primarily focused on the recited “single measuring unit” and “single location”. In response to Applicant’s arguments, it can be noted that the claim language does not clearly and specifically define/recite the boundaries of said “single measuring unit” and “single location”. A single measuring unit may comprise multiple sensing units. A single location may be a single location at component level or a single location at system level.
Furthermore, the claim language does not define/recite the process step(s) performed by the first process equipment and second process equipment. Webb discloses performing actuation (first process step) and agitation (second process step).
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 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) 1-4, 7-8, 10-15 and 18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Webb, US Patent Application Publication No. 2009/0104594 (hereinafter Webb).
Regarding claims 1-4, 7-8, and 10-15 Webb discloses all the claimed limitations, as outlined below.
Claim 1. A device assembly for controlling an integrated continuous pharmaceutical or biopharmaceutical manufacturing process, the device assembly comprising: a first process equipment adapted for performing a first process step (Paragraphs 0020, 0025-0026 and 0038-0040 - - actuators 450-480); a second process equipment adapted for performing a second process step subsequent to the first process step (Paragraphs 0020, 0025-0026 and 0038-0040 – agitators 130); a single measuring unit adapted for measurement of at least one set of signals of a liquid process medium at a single location, the set of measured signals depending on at least a first parameter and a different second parameter (Paragraphs 0020, 0025-0026 and 0038-0040 - - collectively sensors 150-180); and an evaluation and control unit adapted for evaluating the set of measured signals to determine a value of the first parameter and a value of the second parameter; the evaluation and control unit being further adapted for determining a first corrective feedback based on the value of the first parameter (Paragraphs 0020, 0025-0026 and 0038-0040 – controller 300) and a different second corrective feedback based on the value of the second parameter (Paragraphs 0020, 0025-0026 and 0038-0040 - - feedback 350-380); and the evaluation and control unit being further adapted for controlling the first process step by providing the first corrective feedback to the first process equipment and for controlling the subsequent second process step by providing the second corrective feedback to the second process equipment (Paragraphs 0020, 0025-0026 and 0038-0040 – feedback 350-380).
Claim 2. A device assembly for controlling an integrated continuous pharmaceutical or biopharmaceutical manufacturing process, the device assembly comprising: a first process equipment adapted for performing a first process step (Paragraphs 0020, 0025-0026 and 0038-0040 - - actuators 450-480); a second process equipment adapted for performing a second process step subsequent to the first process step (Paragraphs 0020, 0025-0026 and 0038-0040 - agitators 130); a single measuring unit adapted for measurement of at least two different sets of signals of a liquid process medium at a single location, a first set of measured signals depending on at least a first parameter; and a different second set of measured signals depending on at least a different second parameter (Paragraphs 0020, 0025-0026 and 0038-0040 collectively sensors 150-180); and an evaluation and control unit adapted for evaluating the first set of measured signals to determine a value of the first parameter and for evaluating the second set of measured signals to determine a value of the second parameter; the evaluation and control unit (Paragraphs 0020, 0025-0026 and 0038-0040 – controller 300) being further adapted for determining a first corrective feedback based on the value of the first parameter and a different second corrective feedback based on the value of the second parameter; and the evaluation and control unit being further adapted for controlling the first process step by providing the first corrective feedback to the first process equipment and for controlling the subsequent second process step by providing the second corrective feedback to the second process equipment (Paragraphs 0020, 0025-0026 and 0038-0040 – feedback 350-380).
Claim 3. The device assembly according to claim 2, characterized in that the measuring unit is adapted for simultaneous measurement of the first and second sets of signals (Paragraphs 0020, 0025-0026 and 0038-0040).
Claim 4. The device assembly according to claim 1, characterized in that the measuring unit is adapted for repeated measurement of the set(s) of signals (Paragraphs 0020, 0025-0026 and 0038-0040).
Claim 7. The device assembly according to claim1, characterized in that the measuring unit is arranged in the first process equipment in a bioreactor of the first process equipment (Paragraphs 0020, 0025-0026 and 0038-0040).
Claim 8. The device assembly according to claim 1, characterized in that the measurement unit is a measuring cell, including a flow-through measurement chamber, which is part of a spectrometer, based on at least one of the following spectroscopic techniques: scattering, Raman, SERS, MIR, NIR, UV/Vis, fluorescence (Paragraphs 0020, 0025-0026 and 0038-0040).
Claim 10. A method for controlling an integrated continuous pharmaceutical or biopharmaceutical manufacturing process, the process comprising at least a first process step performed in or by a first process equipment (Paragraphs 0020, 0025-0026 and 0038-0040 - - actuators 450-480); and a subsequent second process step performed in or by a second process equipment (Paragraphs 0020, 0025-0026 and 0038-0040 agitators 130); the method comprising the following steps: measuring at least one set of signals of a liquid process medium at a single location, the set of measured signals depending on at least a first parameter and a different second parameter (Paragraphs 0020, 0025-0026 and 0038-0040 - collectively sensors 150-180); evaluating the set of measured signals to determine a value of the first parameter and a value of the second parameter; determining a first corrective feedback based on the value of the first parameter and a different second corrective feedback based on the value of the second parameter; controlling the first process step by providing the first corrective feedback to the first process equipment; and controlling the subsequent second process step by providing the second corrective feedback to the second process equipment (Paragraphs 0020, 0025-0026 and 0038-0040 – controller 300 and feedback 350-380).
11. A method for controlling an integrated continuous pharmaceutical or biopharmaceutical manufacturing process, the process comprising at least a first process step performed in or by a first process equipment (Paragraphs 0020, 0025-0026 and 0038-0040 - - actuators 450-480); and a subsequent second process step performed in or by a second process equipment (Paragraphs 0020, 0025-0026 and 0038-0040 agitators 130);); the method comprising the following steps: measuring at least two different sets of signals of a liquid process medium at a single location, a first set of measured signals depending on at least a first parameter and a different second set of measured signals depending on at least a different second parameter (Paragraphs 0020, 0025-0026 and 0038-0040 - -collectively sensors 150-180); evaluating the first set of measured signals to determine a value of the first parameter and for evaluating the second set of measured signals to determine a value of the second parameter;
determining a first corrective feedback based on the value of the first parameter and a different second corrective feedback based on the value of the second parameter; controlling the first process step by providing the first corrective feedback to the first process equipment; and controlling the subsequent second process step by providing the second corrective feedback to the second process equipment (Paragraphs 0020, 0025-0026 and 0038-0040 – controller 300 and feedback 350-380).
12. The method according to claim 11, wherein the first and second sets of signals are measured simultaneously during the running process (Paragraphs 0020, 0025-0026 and 0038-0040).
13. The method according to claim 11, characterized in that wherein the set(s) of signals are measured repeatedly during the running process (Paragraphs 0020, 0025-0026 and 0038-0040).
14. The method according to claim 11, wherein the set(s) of signals are measured in a connecting line, or in a bypass line, between the first process step and the second process step (Paragraphs 0020, 0025-0026 and 0038-0040).
15. The method according to claim 11, characterized in that the step of measuring set(s) of signals includes measuring a spectrum of the liquid process medium, preferably at least one of the following spectra: scattering, Raman, SERS, MIR, NIR, UV/Vis, fluorescence (Paragraphs 0020, 0025-0026 and 0038-0040).
18. (New) The method according to claim 11, characterized in that the second process step is a different type of process step than the first process step (Paragraphs 0020, 0025-0026 and 0038-0040).
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 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.
Claims 5-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Webb, US Patent Application Publication No. 2009/0104594 (hereinafter Webb) in view of Huang, Edwin P., Christopher P. Marquis, and Peter P. Gray. "Process development for a recombinant Chinese hamster ovary (CHO) cell line utilizing a metal induced and amplified metallothionein expression system." Biotechnology and bioengineering 88.4 (2004): 437-450 (hereinafter Huang).
Regarding claims 5-6, Webb discloses all the limitations of the base claims as outlined above.
Webb fails to clearly specify:
Claim 5. The device assembly according to claim1, characterized in that the measuring unit is arranged in a connecting line, or in a bypass line, between the first process equipment and the second process equipment.
Claim 6. The device assembly according to claim 1, characterized in that the measuring unit is arranged in a harvest line downstream of a bioreactor.
However, Huang teaches:
Claim 5. a measuring unit is arranged in a connecting line, or in a bypass line, between a first process equipment and a second process equipment (Page 441 - - see for example:
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Claim 6. a measuring unit is arranged in a harvest line downstream of a bioreactor (Page 441 - - see for example:
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The applied prior art is considered analogous art to the claimed invention because they relate to same field of endeavor. They relate to bioreactors.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the above bioreactor process control system, as taught by Webb, and incorporating the concept of measuring in a bypass/harvest line, as taught by Huang.
One of ordinary skill in the art would have been motivated to do this modification in order to improve the determination of product yield, as suggested by Huang (Page 441).
Claims 9 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Webb, US Patent Application Publication No. 2009/0104594 (hereinafter Webb) in view of Lourenço, Nídia D., et al. "Bioreactor monitoring with spectroscopy and chemometrics: a review." Analytical and bioanalytical chemistry 404.4 (2012): 1211-1237 (hereinafter Lourenço).
Regarding claims 9 and 16, Webb discloses all the limitations of the base claims as outlined above.
Webb fails to clearly specify:
Claim 9 and 16. The device assembly according to claim 1, characterized in that the evaluation and control unit is adapted for applying a first chemometric model and a different second chemometric model to the set(s) of measured signals.
However, Lourenço teaches:
Claim 9 and 16. The device assembly according to claim 1, characterized in that an evaluation and control unit is adapted for applying a first chemometric model and a different second chemometric model to a set(s) of measured signals (Page 1230 Section labeled “Advantages and disadvantages” - - using both PLS and PCR . Chemometric methods are utmost importance for interpretation of the large amounts of data generated by online measurements. Qualitative and quantitative analysis is performed).
The applied prior art is considered analogous art to the claimed invention because they relate to same field of endeavor. They relate to bioreactors.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the above Bioreactor process and control system taught by Webb, and incorporating the measurement techniques, as taught by Lourenço.
One of ordinary skill in the art would have been motivated to do this modification in order to facilitate interpretation of large amounts of data, as suggested by Lourenço.
Claim 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Webb, US Patent Application Publication No. 2009/0104594 (hereinafter Webb) in view of Galliher et al., US Patent No. 9,109,193 (hereinafter Galliher).
Regarding claim 17, Webb discloses all the limitations of the base claims as outlined above.
Webb fails to clearly specify a connecting line extending between and fluidly connecting the first process equipment and the second process equipment.
However, Galliher teaches a connecting line extending between and fluidly connecting the first process equipment and the second process equipment (C11 L58-67 and C12 L1-5).
The applied prior art is considered analogous art to the claimed invention because they relate to same field of endeavor. They relate to bioreactor systems.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the above bioreactor process and control system, as taught by Webb, and incorporating the concept of line connected process equipment, as taught by Galliher.
One of ordinary skill in the art would have been motivated to do this modification in order to provide increased efficiency, as suggested by Galliher (See C1 L39).
Citation of Pertinent Prior Art
The following prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Vann, Lucas, et al., "Use of near-infrared spectroscopy (NIRs) in the biopharmaceutical industry for real-time determination of critical process parameters and integration of advanced feedback control strategies using MIDUS control." Journal of Industrial Microbiology and Biotechnology 44.12 (2017): 1589-1603.
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 extension fee 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 CARLOS R ORTIZ RODRIGUEZ whose telephone number is (571)272-3766. The examiner can normally be reached on Mon-Fri 10:00 am- 6:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mohammad Ali can be reached on 571-272-4105. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CARLOS R ORTIZ RODRIGUEZ/ Primary Examiner, Art Unit 2119
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