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/Restriction
REQUIREMENT FOR UNITY OF INVENTION
As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
When Claims Are Directed to Multiple Categories of Inventions:
As provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and a process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c).
Restriction is required under 35 U.S.C. 121 and 372.
This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1.
In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted.
Group I, claim(s) 1, 2, 5-8, 15-19, 30 and 33, drawn to a bioreactor system for culturing cells.
Group II, claim(s) 45, 46 and 48-52, drawn to a method of controlling a bioreactor system.
The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons:
Groups I and II lack unity of invention because even though the inventions of these groups require the technical feature of a bioreactor with a cell culture vessel, a fluid flow path, a media conditioning vessel and an outlet sensor arranged downstream of the outlet of the downstream of the dell culture vessel this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of US 2005/0176140 A1 (hereafter referred to as ‘140). ‘140 discloses a bioreactor (bioreactor 116), a media reservoir (reservoir 101, i.e. the media conditioning vessel), a fluid flow path (process lines 110, 112, 134 and 138) and a sensor that is downstream of the outlet of the bioreactor (sensors 106 & 107; Fig. 1; [0046]).
During a telephone conversation with Applicant’s representative, Brock Riggs on 07/29/2026 a provisional election was made without traverse to prosecute the invention of Group I, claims 1, 2, 5-8, 15-19, 30 and 33. Affirmation of this election must be made by applicant in replying to this Office action. Claims 45, 46 and 48-52, are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 03/04/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 17 and 18 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.
Claim 17 recites the limitation "the at least one conditioning component" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 18 recites the limitation "the at least one conditioning component" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Appropriate corrective action is required.
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.
Claims 1, 2, 5-8, 15-19, 30 and 33 are rejected under 35 U.S.C. 102a1 as being anticipated by Benedict et al. (US 2005/0176140 A1 – hereafter ‘140).
‘140 discloses a cell culture system that uses a bioreactor (Abstract) that includes the following limitations for claim 1:
“A bioreactor system for culturing cells”: ‘140 discloses a bioreactor system (Fig. 1; [0046]) that is used for culturing cells ([0029]).
“a cell culture vessel comprising at least one interior reservoir, an inlet fluidly connected to the reservoir, and an outlet fluidly connected to the reservoir”: ‘140 discloses a bioreactor (bioreactor 116; Fig. 1) that includes an interior reservoir (Fig. 1), with a fluid inlet (inlet process line 112; [0046]) and an outlet line (process line 134; [0046]; Fig. 1). The inlet and outlet are fluidically connected to the interior of the bioreactor.
“a fluid flow path configured to supply fluid to the inlet and receive fluid from the outlet”: ‘140 discloses a fluid flow path that supply fluid to the inlet and receives fluid from the outlet (process lines 110, 112, 134 and 138; Fig. 1; [0046]).
“a media conditioning vessel fluidly connected to the cell culture vessel”: ‘140 discloses a media reservoir (reservoir 101; Fig. 1; [0046]) that is connected to the bioreactor and is being interpreted as the media conditioning vessel of the instant application.
“an outlet sensor arranged at or downstream of the outlet of the cell culture vessel”: ‘140 discloses two sensors (sensors 106 and 107) that are attached to the media reservoir and are being interpreted as being downstream from the fluid outlet (Fig. 1; [0046]).
“ an outlet sensor is configured to detect a property of cell culture media exiting he cell culture vessel via the outlet”: The sensors of ‘140 detect a property such as temperature or pH ([0046]).
“wherein the bioreactor system is configured to adjust a property of the cell culture media based on the property detected by the outlet sensor.”: The system is configured to control a property detected by the sensor such as pH ([0046]).
For claim 2, ‘140 discloses that the sensor detects a property such as temperature or pH and adjusts this based on the reading by the sensor ([0046]).
For claim 5, ‘140 discloses a pump (pump 137; [0046]; Fig. 1) that controls the fluid flow path.
For claim 6, the system of ‘140 is fully capable of adjusting the flow rate based on a property detected by the system ([0046]).
For claim 7, the system is fully capable of adjusting the flow rate based on the level of dissolved gas ([0046]).
For claim 8, ‘140 discloses that a sensor is used to detect a property of the media reservoir such as temperature ([0046]; sensor 106; Fig. 1) and the system is configured to adjust the temperature based on the measurement from the sensor.
For claim 15, ‘140 discloses microcontrollers such as a temperature controller (controller 166; Fig. 1; [0046]) controls a property of the media reservoir.
For claim 16, the property controlled by the microcontroller is temperature ([0046]).
For claim 17, ‘140 discloses that the microcontroller receives a signal from the sensor and adjusts the temperature of the media reservoir ([0046]). The heater ([0046]) is the conditioning component that is being controlled by the microcontroller.
For claim 18, the microcontroller receives a signal from the media reservoir and uses that the operate a feed pump (pump 111; Fig. 1; [0046]). The feed pump is being interpreted as the conditioning component of the instant claim.
For claim 19, the substrate is being interpreted as material operated on by the apparatus which does not structurally define the claimed invention over the prior art. See MPEP §2115.
For claim 30, the system of ‘140 is fully capable of flowing the culture media continuously from the inlet and toward the outlet.
For claim 33, ‘140 discloses using a sensor such as an oxygen probe (probe 113; Fig. 1; [0046]) that is being interpreted as an in-line sensor.
Therefore, ‘140 meets the limitations of claims 1, 2, 5-8, 15-19, 30 and 33.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Ramakrishna et al. (US 2019/0338231 A1) which disclose a wave bioreactor.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL L HOBBS whose telephone number is (571)270-3724. The examiner can normally be reached Variable, but generally 8AM-5PM M-F.
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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/MICHAEL L HOBBS/Primary Examiner, Art Unit 1799
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