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 .
Response to Amendment
Claims 7 and 15 are amended. Claims 7-10 and 15-18 are pending in this application.
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.
Claim(s) 7-10 and 15-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Goldberg et al., US 2022/0261990 in view of Wang et al., “Differentiation of Cytopathic Effects (CPE) induced by influenza virus infection using deep Convolutional Neural Networks (CNN)”.
Regarding claim 7, Goldberg discloses an apparatus for analyzing cell culture images (fig. 1B, element 100; para 0063; a biological cell analysis system that utilizes machine learning to detect early-stage cellular morphological changes) comprising:
an image processor (para 0064; a processor) for image processing plaque size, clarity, border definition and distribution in cell culture images of a cell culture including a pathogen (fig. 1B; element 102; para 0045-0047 and 0065; the image processing system processes raw image data and generates feature vectors from the captured images of the biological cells. The plaque assay (i.e., plaque assay implies noting plaque size, clarity, border definition, and distribution of the cell monolayer (often termed plaque morphology)) is one of the most important assays in virology. It measures the number of infectious viral particles in a sample by observing the effects of infection on a culture of susceptible cells. This assay counts the number of infectious viral particles in a sample (plaque-forming units or PFUs));
a database for storing image metadata (fig. 1B, elements 101 and 124; para 0064; digital images of cells and associated metadata are stored in a storage device and a database);
a data mining processor (fig. 1B, element 104; para 0067; a machine learning (AI) model) for mining image metadata using machine learning to determine growth and virulence of the pathogen (fig. 1B, element 104; para 0066-0067, 0095, and 0133; the machine learning (AI) model is used with one or more classifier algorithms to classify biological cells and to detect morphological changes of the classified biological cells over time; In the analytical mode, images of biological cell assays can be analyzed to recognize and classify biological cells; During the prediction phase, the selected model is then used to classify cells at a time point corresponding to the selected model. The result is a per-well prediction of the degree of infection (predicted infectivity), being made within a much shorter time period (such as within hours, instead of days)).
Goldberg further discloses detecting morphological changes in virus-infected cells can be made before plaques caused by cell death are observable (typical cell death in 2-14 days). Collect an appropriate training set of infected cells, in a state prior to them developing visible changes (which are typically lysis and death) (Abstract; para 0050).
Goldberg discloses claim 7 as enumerated above, but Goldberg does not explicitly disclose identifying a virus based upon a pattern of cell death as claimed.
However, Wang discloses observation of cytopathic effects (CPE) induced by virus infection is a practical method to determine the presence of viruses in the clinical specimens. In the Fig 1C, 50% of the cells became rounded and some of them began to be detached from the culture flask due to cell death induced by severe cytopathic effects (fig. 1; Author summary and Results-Model training).
Therefore, taking the combined disclosures of Goldberg and Chen as a whole, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate observation of cytopathic effects (CPE) induced by virus infection is a practical method to determine the presence of viruses in the clinical specimens. In the Fig 1C, 50% of the cells became rounded and some of them began to be detached from the culture flask due to cell death induced by severe cytopathic effects as taught by Chen into the invention of Goldberg for the benefit of detecting the slight changes at the initial stage of CPE development using the CNN model (Wang: Author summary).
Regarding claim 8, the apparatus according to claim 7, Goldberg in the combination further discloses comprising a data mining processor for mining the image metadata to optimize plaque assay conditions para 0045-0047, 0067, and 0088).
Regarding claim 9, the apparatus according to claim 8, Goldberg in the combination further discloses wherein the cell images comprise a sequence of images taken over a period of time (para 0089 and 0111) and wherein the data mining processor enables a backward time review of to search for the plaques that behave differently from others in backward time (para 0133 and 0145-0146).
Regarding claim 10, the apparatus according to claim 9, Goldberg in the combination further discloses wherein the cell culture is unstained (para 0086, 0096, and 0109) and wherein the data mining processor enables the replaying of the images in forward time to display the pathogen attacking a cell (para 0133 and 0145-0146) and permits one to remove a virus sample while it is still alive to see why it behaves differently from others (para 0068, 0073, and 0083).
Regarding claim 15, this claim recites substantially the same limitations that are performed by claim 7 above, and it is rejected for the same reasons.
Regarding claim 16, this claim recites substantially the same limitations that are performed by claim 8 above, and it is rejected for the same reasons.
Regarding claim 17, this claim recites substantially the same limitations that are performed by claim 9 above, and it is rejected for the same reasons.
Regarding claim 18, this claim recites substantially the same limitations that are performed by claim 10 above, and it is rejected for the same reasons.
Response to Arguments
Applicant's arguments with respect to claims 7-10 and 15-18 have been considered but are moot in view of the new ground(s) of rejection.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/VAN D HUYNH/Primary Examiner, Art Unit 2665
