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 .
DETAILED ACTION
Summary
This is the initial Office action on the 18/833422 application with claims filed on 7/26/24.
Claims 1-18 and 22-26 are pending and have been fully considered.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/22/25 and 7/26/24 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The disclosure is objected to because of the following informalities: the continuing information paragraph should be updated to include reference to the PCT filing that the current application is a 371 filing from.
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.
Claim 7 is 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 7, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
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)1-3, 5-9, 11-13, 22-25 is/are rejected under 35 U.S.C. 102a1 as being anticipated by DOWNEY (WO 2020/041454) as supplied by applicant on the IDS dated 7/26/24.
Regarding claim 1, 2, 11 DOWNEY discloses a system for predicting concentrations (assessing biomass) in a bioreactor system (Abs) comprising a bioreactor 50 including a reactor (container) including a fixed bed [0095, Fig 2]; a biomass sensor 24 or analyzer 70 (at least one sensor for sensing one or more parameters representative of biomass) [0043-44, 0047, 0081], and a controller 60 which receives data on various parameters or attributes from the sensor/analyzer and includes predictive models to forecast concentrations in the future [0053, 0066-67] as well as maintain cell density or volume [0060-61], in which the quality attribute monitored can be lactate concentration (parameter comprises cell culture byproduct) [0034] or glucose concentration [0053].
Regarding claim 3, DOWNEY discloses the analyzer may comprise mass spectrometers (sensor comprises a spectroscopic sensor) [0088].
Regarding claim 5-6, DOWNEY discloses an inline (adapted to determine oxygen input or outlet concentration depending where in the line it is placed) oxygen sensor (sensor comprises a gas sensor associated with bioreactor) [0047, 0068].
Regarding claim 7, DOWNEY discloses the sensor 24 is positioned in a dedicated line for drawing liquid from the bottom of the reactor (other than a surface of the bioreactor) [Fig 1].
Regarding claim 8, DOWNEY discloses the system may use an aseptic auto sampler to deliver samples for measuring or monitoring one or more parameters (sensor is associated with automated sampler) [0048-0052].
Regarding claim 9, 12 DOWNEY discloses the controller can include a model (correlation model) that is capable of forecasting concentrations in the future (controller adapted to estimate amount of biomass at future time) based on monitored parameters [0010-11, 0067].
Regarding claim 13, DOWNEY discloses sampling is done aseptically (bioreactor must remain sealed to be aseptic) [0048].
Regarding claim 22-23, DOWNEY discloses a system for predicting concentrations (assessing biomass) in a bioreactor system (Abs) comprising a bioreactor 50 including a reactor (container) including a fixed bed [0095, Fig 2]; a biomass sensor 24 or analyzer 70 (at least one sensor for sensing one or more parameters representative of biomass) [0043-44, 0047, 0081], and a controller 60 which receives data on various parameters or attributes from the sensor/analyzer and includes predictive models to forecast concentrations in the future [0053, 0066-67] as well as maintain cell density or volume [0060-61], in which the sensor 24 is positioned in a dedicated line for drawing liquid from within the bottom of the reactor (other than a surface of the bioreactor) [Fig 1]. As the sensor of DOWNEY meets the claimed limitation regarding location, it is considered capable of providing the functional limitation of limiting the incidence of bubbles.
Regarding claim 24-25, DOWNEY discloses the controller can include a model (correlation model) that is capable of forecasting concentrations in the future (controller adapted to estimate amount of biomass at future time) based on monitored parameters [0010-11, 0067].
Claim(s) 14 is/are rejected under 35 U.S.C. 102a1 as being anticipated by of MAIRESSE (US 2021/0155892) as supplied by applicant on the IDS dated 7/26/24.
Regarding claim 14, MAIRESSE discloses a system for producing biomolecules comprising assessing the cell density of structured fixed beds in a bioreactor [0059] comprising a bioreactor, which is a fixed bed bioreactor (bioreactor including container and fixed bed within) [0071-73, fig 1], the bioreactor in a recirculation loop 301, 300 [0166, Fig 1] and at least one sensor for sensing one or more parameters provided at a location before fluid enters/re-enters the chamber (sensor associated with recirculation loop) [0183].
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.
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) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over DOWNEY (WO 2020/041454) as applied above and further in view CLARK (US 2013/0038727).
Regarding claim 4, DOWNEY discloses a variety of sensors and analyzers [0043-44, 0047, 0081] can be used but does not explicitly disclose an enzymatic sensor.
However, CLARK discloses a system for monitoring cell culture comprising a sensor which can be a sensing device that measures information such as enzyme-based parameters (enzymatic sensor) [0050, 0052].
It would have been obvious to one of ordinary skill before the invention was filed to modify the sensor used by DOWNEY to include the enzyme sensor as taught by CLARK because it allows for monitoring enzyme-based parameters [0050] which would provide for a greater range of parameters that could be monitored.
Claim(s) 10, 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over DOWNEY (WO 2020/041454) as applied above and further in view of MAIRESSE (US 2021/0155892) as supplied by applicant on the IDS dated 7/26/24.
Regarding claim 10, 26 DOWNEY discloses the results of the model produced by the controller can be presented to a user [0069] but does not explicitly disclose a display.
However, MAIRESSE discloses a bioreactor system with a process controller that records data from sensors and has software for monitoring the process flow, in which access to the controller is provided by a computer with a screen 29 [0177-178]. It would have been obvious to one of ordinary skill before the invention was filed to modify the controller system of DOWNEY to include the screen as taught by MAIRESSE because it allows the user to follow the process and operate the system [0178].
Claim(s) 15-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over MAIRESSE (US 2021/0155892) as applied to claim 14 above, in view of DOWNEY (WO 2020/041454) as supplied by applicant on the IDS dated 7/26/24.
Regarding claim 15-17, MAIRESSE discloses the system of claim 14 and further discloses a controller for monitoring the bioreactor that is provided with software for monitoring controlling and recording the process flow and parameters [0152-154] but does not explicitly disclose the controller is adapted for correlating the parameters to an amount of biomass.
However, DOWNEY discloses a system for predicting concentrations (assessing biomass) in a bioreactor system (Abs) comprising a bioreactor 50 including a reactor (container) including a fixed bed [0095, Fig 2]; a biomass sensor 24 or analyzer 70 (at least one sensor for sensing one or more parameters representative of biomass) [0043-44, 0047, 0081], and a controller 60 which receives data on various parameters or attributes from the sensor/analyzer and includes predictive models to forecast concentrations in the future [0053, 0066-67] as well as maintain cell density or volume [0060-61] in which the controller can include a model (correlation model) that is capable of forecasting concentrations in the future (controller adapted to estimate amount of biomass at future time) based on monitored parameters [0010-11, 0067].
It would have been obvious to one of ordinary skill before the invention was filed to modify the controller of MAIRESSE to include the models for correlating the one or more parameters to an amount of biomass as taught by DOWNEY because it allows for a simplification of the detection of the effect of changing an attribute influencing parameter on the cellular growth/density [0032-34].
Regarding claim 18, MAIRESSE discloses a process controller that records data from sensors and has software for monitoring the process flow, in which access to the controller is provided by a computer with a screen 29 [0177-178].
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See references on the attached PTO 892 that represent the state of the art of applicant’s endeavor.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIELLE B HENKEL whose telephone number is (571)270-5505. The examiner can normally be reached M-Th 11-7 EST, Alt. Fridays.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Marcheschi can be reached at 571-272-1374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DANIELLE B HENKEL/Examiner, Art Unit 1799
/William H. Beisner/Primary Examiner, Art Unit 1799
