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
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.
Status of the claims
Claims 1-6, 8-15, 17-18, 20-21, 23 and 25 are examined on merits in this office action to the extant it encompasses the elected species.
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 of this title, 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 1-6, 8-15, 17-18, 20-21, 23 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Hayes et al. (WO 2018/206746A1).
In regards to claims 1 and 25, Hayes discloses a method of culturing cells comprising:
Loading cells in a cell sample to form a loaded cell sample,
Controlling the concentration of oxygen in the loaded cell sample,
Ascertaining (monitoring) intracellular oxygen concentration of the loaded cells within the loaded cell sample by measured intracellular oxygen concentration based upon a known conversion algorithm, and
Adjusting the concentration of oxygen to target oxygen concentration wherein the determination is based on comparing the determined oxygen concentration with the target oxygen concentration, thereby adjusting the pericellular oxygen concentration to a target oxygen concentration (claim 1).
Hayes teaches use of equipment to control the concentration of oxygen in the gaseous headspace of cell cultures more closely mimic in vivo conditions (para [0003]), thus the equipment can be considered as cell culture incubator. Hayes teaches the that cell culture equipment comprises enclosed chamber so as to define a gaseous headspace in fluid communication with the pericellular loaded cell sample within the chamber, and form a micro-environmental pericellular space within the pericellular loaded cell sample (para 0017]).
Hayes does not describe the cell culture equipment as a cell culture incubator. However, Hayes teaches use of equipment to control the concentration of oxygen in the gaseous headspace of cell cultures more closely mimic in vivo conditions (para [0003]), thus the equipment can be considered as cell culture incubator and Hayes teaches flow of oxygen in the gaseous headspace (para [0026]), which can be considered as the cell culture chamber (cell culture incubator) adapted for inflow of gas at the headspace. Hayes teaches CLARIOstar plate reader equipped with an Atmospheric Control Unit from BMG Labtech GmbH allowing user control of oxygen and carbon dioxide concentrations in the headspace of a cell sample are known, such as the CLARIOstar plate reader equipped with an Atmospheric Control Unit from BMG Labtech GmbH of Ortenberg, Germany.
In regards to claims 2 and 3, Hayes teaches optical sensors for sensing and reporting oxygen concentration are widely known (para [0036]) and sensors at the bottom of the culture (para [0037]).
In regards to claims 4 and 5, Hayes teaches measuring pericellular oxygen concentration based upon a known conversion algorithm i.e. mathematical calculation (para [0018]). Hayes does not teach utilizing mathematically modeled equation of Michaclis-Menten kinetics, but however, since Hayes teaches utilizing known conversion algorithm, various know mathematical model for measuring oxygen concentration would be obvious to one of ordinary skilled in the art.
In regards to claims 6 and 8, Hayes, as described above Hayes teaches cell culture gas is selected from oxygen and carbon dioxide (para [0031], [0040]).
In regards to claims 8 and 9, Hayes teaches CLARIOstar plate reader equipped with an Atmospheric Control Unit from BMG Labtech GmbH (para [0031]) capable of regulating O2 and CO2 gas levels and having inlet and outlet flow.
In regards to claims 11-13, Hayes teaches maintaining intracellular oxygen concentration of cell samples formed from a wide variety of viable cells, including specifically but not exclusively 2D and 3D samples of microbial cells, yeast cells and mammalian cells. (para [0032], [0042], [0044]).
In regards to claims 14-15, 17-18, 20-21 and 23, Hayes teaches that the concentration of oxygen in tissues of the body can be very different depending upon the location and type of tissue, ranging from 19-20% in cells in the lung (close to atmospheric oxygen), to 5-6% for liver cells, and even to 1-2% in cells deeper in the body (e.g., skeletal muscle) (para [0001]). Hayes teaches that cellular oxygen concentrations is known to those who working in specific fields (e.g., hypoxia research). Hayes teaches that the target oxygen concentration or concentration range can be selected as desired (para [0040]). Hayes teaches that the target oxygen concentration is selected to replicate in vivo intracellular oxygen concentration for the type of cells forming the cell sample (claim 13). Therefore, since the basic concept of culturing cells by increasing or decreasing oxygen flow to culture incubator to provides desired target pericellular oxygen concentration is disclosed by Hayes, different target oxygen concentration for maintain different conditions and different cell types and different percentage of target oxygen concentrations would be obvious and would be within the purview of one of ordinary skilled in the art. In regards to recitation of culture incubator is a bioreactor, Hayes, as described above teaches cell culture incubation allowing flow of oxygen in the gaseous headspace equipped with an Atmospheric Control Unit a known quantity of gas containing a known high or low concentration of oxygen can be introduced into the gaseous headspace for increasing or decreasing the concentration of oxygen. Thus, the equipment can also be considered as a bioreactor.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHAFIQUL HAQ whose telephone number is (571)272-6103. The examiner can normally be reached on Mon-Fri 8-4:30.
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/SHAFIQUL HAQ/Primary Examiner, Art Unit 1678
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