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 .
In response to the restriction requirement, Applicant elected claims 1-3 for further examination. As a result, claims 4-22 are withdrawn from further prosecution.
Claim Objections
Claim 1 is objected to because of the following informalities: The claim recites the limitation “the cells and samples” (on line 6) with insufficient antecedent basis. Appropriate correction is required.
Claim Rejections - 35 USC § 101
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.
Claim 1 is rejected under 35 U.S.C. 101 because:
The claim recites the steps of performing biochemical assay on the cells and performing structural assay on the cells to output data for the dataset to predict of liver toxicity, with no specific on the performing of the assays, and on how the prediction takes place from the dataset; as a result, these steps as analyzed can “practically be performed in the Human Mind” with/without sketching on paper. As stated in MPEP 2106.04(a)(2), III. Mental Processes, “A claim that encompasses a Human Performing the step(s) mentally with or without a physical aid recites a mental process”; as a result, the claim recites a mental process that falls within at least one of the abstract idea groupings (MPEP 2106.04(a) Abstract Ideas: The enumerated groupings of abstract ideas: Mathematical concepts, Certain methods of organizing human activity, Mental processes). As a result, the claims recite a judicial exception.
In addition, the additional action (recited in the claim) of applying test compounds to the test wells of a hepatocyte model, when viewed in combination of as a whole, adds insignificant extra-solution to the judicial exception that does not integrate the judicial exception into a practical application, and also does not amount significant more to add an inventive concept to the claim.
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.
2. Claim 1 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential structural cooperative relationships of elements, such omission amounting to a gap between the necessary structural connections. See MPEP § 2172.01. The omitted structural cooperative relationships are:
The claim, in step e, cites a creation of dataset comprising “a structural feature measured from the single well” and “a biochemical feature measured from the single well”. The claim, in steps c and d, however cites “obtaining a result from the biochemical assay” and “obtaining an image from the structural assay”. As a result, it is unclear on structural connections between “a structural feature measured from the single well” and “obtaining an image from the structural assay”; and “a biochemical feature measured from the single well” and “obtaining a result from the biochemical assay”. In other words, it is unclear how to define the measured structural feature from the obtained image from the structural assay; and how to define the measured biochemical feature from the obtained result from the biochemical assay.
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, 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.
3. Claim(s) 1-3 is/are rejected under 35 U.S.C. 103 as being unpatentable over McKim (US 2007/0218457) in view of Zink et al. (US 11321826).
Regarding to claim 1:
McKim discloses a high-throughput method of analyzing liver toxicity comprising:
preparing a two-dimensional hepatocyte model on a multi-well plate, wherein the multi-well plate comprises a plurality of test wells (paragraph [0142]: The cells are seeded in multiwell (96-well) plates. Paragraph [0137]: The cell is human liver (hepatic) cell);
applying a library of test compounds to the plurality of test wells (paragraph [0143]: Once the cell cultures are established, various concentrations of the compound being tested are added to the media and the cells);
performing biochemical assay on the cells or samples from the plurality of test wells and obtaining a result from the biochemical assay (paragraph [0125]: Biochemical assays measure changes in specific biochemical processes);
creating dataset comprising a plurality of data points, wherein each data point corresponds to a single well out of the plurality of test wells and comprises a reference corresponding to the single well, a test compound and its concentration applied to the single well, and a biochemical feature measured from the single well, and providing the dataset for prediction of liver toxicity of the test compounds (Abstract: Measuring at least one indicator of cell health at the at least one concentration of compound for the at least one cell type, and performing a concentration response analysis, from which a toxic concentration can be determined).
McKim however does not teach performing structural assay on the cells on the plurality of test wells by staining the cells with markers specific to cellular structural features and obtaining an image from the structural assay and including a structural feature measured from the single well in the dataset for predicting of liver toxicity of the test compounds.
Zink et al. discloses a method for predicting liver injury in vivo due to hepatocyte damage by a test compound, comprising staining cells with markers specific to cellular structural features (FIG. 1, element 110: Cell culture treating and staining) and obtaining an image for further defining a structural feature measured from the single well for predicting of liver toxicity of the test compound (FIG. 1: The imaging device 120 obtains an image of the cell. Abstract: The method includes acquiring images of fluorescently stained cells obtained from a cell culture for further predicting the probability of liver injury by the test compound).
Therefore, it would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to modify McKim’s method to also include staining cells with markers specific to cellular structural features and obtaining an image define a structural feature to gain the accuracy in prediction of compound-induced liver injury based on hepatocyte damage as taught by Zink et al. (column 1, lines 24-27).
McKim further teaches the following claims:
Regarding to claim 2: wherein the two-dimensional hepatocyte model comprises a culture of primary human hepatocytes (paragraph [0137]: The cell is a human liver cell, a human hepatic cell).
Regarding to claim 3: further comprising incubating the primary human hepatocytes with the test compounds before performing the biochemical assay or the structural assay (paragraph [0147]: The cells are incubated in these concentrations for a given period of hours. Subsequent to the incubation, the assays are performed for each test compound).
CONTACT INFORMATION
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAM S NGUYEN whose telephone number is (571)272-2151.
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/LAM S NGUYEN/ Primary Examiner, Art Unit 2853