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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 03/18/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because the Abstract is over 150 words. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claims 2-13 and 17-19 are objected to because of the following informalities: For claims 2-13, the claims are listed as “Method” and should be amended to “The method” in order to conform to current U.S. practice. For claims 17-19, the claims are labeled as “System” and should be amended to “The system” in order to conform to current U.S. practice. 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 14 and 15 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.
Claims 14 and 15 recites a use without any active, positive steps delimiting how this uses is actually practiced.
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 14 and 15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because the “Use” claim of claim 14 and 15 fails to recite steps under 35 U.S.C. 101 and 35 U.S.C. 112(b) and therefore fails to recite a claim within one of the statutory classes under 35 U.S.C. 101. See also MPEP §2173.05(q) and §2173.05(q) I.
Appropriate corrective action is required.
Allowable Subject Matter
Claim 1 and 16 are allowed.
The following is an examiner’s statement of reasons for allowance: For claim 1, the prior art taken either singly or in combination fails to teach or reasonably suggest the following limitation when taken in context of the claim as a whole a method for performing alkaline lysis, neutralization and clarification of bacterial cells that includes the following steps: providing a suspension of bacterial cells and providing alkaline lysis solution into a single use mixing bag for performing an alkaline lysis of said bacterial cells, wherein said single use mixing bag comprises an integrated mixer; mixing the content in the single use mixing bag by the integrated mixer during the alkaline lysis; stopping the alkaline lysis by adding a neutralisation solution into the single use mixing bag; clarifying the content in the single use mixing bag after the alkaline lysis has been performed by adding a flocculate lifting agent into the single use mixing bag, whereby at least two phases are separated inside the single use mixing bag, whereby one of said phases is a neutralised and clarified alkaline solution comprising plasmid DNA; removing the neutralised and clarified alkaline solution from the single use mixing bag; and filtering the neutralised and clarified alkaline solution.
For claim 16, the prior art taken either singly or in combination fails to teach or reasonably suggest the following limitation when taken in context of the claim as a whole a system for performing alkaline lysis, neutralisation and clarification of bacterial cells for extracting of plasmid DNA that includes the following limitations: a single use mixing bag which comprises at least one inlet, at least one outlet, of which one is a clarified phase outlet, a vent valve device and an integrated mixer; at least one inlet fluid line connected to at least one of the at least one inlet of the single use mixing bag and having at least one connector for connection to fluid sources comprising fluids to be added to the single use mixing bag at least one inlet pump connected to the at least one inlet fluid line; an outlet fluid line connected to the clarified phase outlet of the single use mixing bag; at least one outlet pump connected to the outlet fluid line; a collection bag connected to the outlet fluid line for collection of a neutralised and clarified alkaline solution removed from the single use mixing bag via the clarified phase outlet; a filter connected to the outlet fluid line and provided between the clarified phase outlet and the collection bag such that a content removed from the clarified phase outlet of the single use mixing bag is filtered through the filter on its way to the collection bag; and a control system connected to the at least one inlet pump, the at least one outlet pump and to a mixer controller which can control the integrated mixer of the single use mixing bag, wherein said control system is configured for controlling the at least one inlet pump, the at least one outlet pump and the integrated mixer in the single use mixing bag to pump content into the single use mixing bag, pump content out from the single use mixing bag and mix the content in the single use mixing bag according to the method of claim 1.
The closest prior art is Urthaler et al. (EP 2088196 A1) that discloses a method for producing biomolecules that includes the steps of providing a cell suspension, a lysis step, a neutralization step and a clarification step. However, Urthaler does not teach the steps of using a mixing bag with an internal mixer and does not perform these steps within the mixing bag.
The next closes prior art is Kjar et al. (US 9,606,077 B2) that discloses a bioreactor with a foam sensor that uses a reactor vessel lined with a flexible bag. Regarding the claimed invention Kjar does not teach or suggest the steps of providing a cell suspension, alkaline lysis, a neutralization step and a clarification step within a mixing bag that includes an integrated stirring element.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Claims 2-13 and 17-19 would be allowable for the same reasons as claims 1 and 16 respectively barring the claim objections raised above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Kennedy, III et al. (US 2017/0298316 A1) discloses a bioreactor with a mixer that can be implemented within a flexible bag.
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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