DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 09/04/2026 has been entered.
Claim(s) 1-4, 6, 22, 24, 41 and 52-54 are rejected under 35 U.S.C. 102(a2).
Claim(s) 55-64 are objected to.
Response to Arguments
Applicant’s arguments with respect to the claim(s) have been considered but are moot in view of the new grounds of rejection presented below.
Claim Rejections - 35 USC § 102
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-4, 6, 22, 24, 41 and 52-54 are rejected under 35 U.S.C. 102(a2) as being anticipated by US Publication 2021/0372933 to Xie et al.
Regarding claims 1-4, 6, 22, 24, 41 and 52-54, Xie discloses and shows in Figures 1-5, a system and method of providing a cancer assessment for a patient (par. 6, 10-11, 13), the method comprising:
isolating a volume of a fluid from a fluid sample of the patient, the volume of fluid including at least one biomarker (par. 3, 13, 24, 50);
adding at least a portion of the volume of fluid to a nanosensor, the nanosensor comprising nanoparticles configured to capture the at least one biomarker and amplify signals emitted by the at least one biomarker via surface-enhanced Raman scattering during subsequent Raman spectroscopy (par. 10-11, 13, 49, 51-52);
performing the Raman spectroscopy on the volume of fluid while the fluid is on the nanosensor to produce a sample Raman spectrum, the sample Raman spectrum having amplified signals indicating the presence of the at least one biomarker on the nanosensor (par. 10-11, 13, 49, 51-52);
processing the sample Raman spectrum using data from template Raman spectra from known samples having cancer characteristics to detect whether the sample comprises one or more of the cancer characteristics (par. 10-11, 13, 53, 56-59); and
based on the detected one or more cancer characteristics, providing the cancer assessment of the patient (par. 3, 10-11, 61);
[claims 2 and 54] wherein the one or more cancer characteristics of the sample are detected based on determining which correlation values obtained by correlating the amplified signals of the sample Raman spectrum to template Raman spectra from the known cancer samples having the cancer characteristics are larger than a correlation threshold (par. 61, 85, 162; wherein a computer processor performs statistical analysis algorithms to match obtained spectra with previously recorded spectra);
[claim 3] wherein the one or more cancer characteristics of the sample are detected by:
performing feature extraction on the Raman sample spectral data to extract feature values (par. 10-12, 53, 53, 56-59);
performing classification by applying the feature values to at least one set of classification models determined for the at least one biomarker to detect the one or more cancer characteristics (par. 10-12, 53, 53, 56-59); and
providing the cancer assessment by incorporating each of the detected cancer characteristics, wherein the classification models are determined using the template Raman spectra from the known cancer samples (par. 10-12, 53, 53, 56-59);
[claim 4] wherein at least one of: the feature extraction is performed using Principal Component Analysis, Multivariate Curve Resolution Analysis or a combination thereof; and the classification model is one of Partial Least Squares Discriminant Analysis (PLSDA), Support Vector Machine Discriminant Analysis (SVMDA) and Artificial Neural Network analysis (ANN) TSNE and Random Forest classification (par. 53-55);
[claim 6] wherein the cancer characteristic is a cancer type, a cancer stage, cancer metastasis, cancer potential for metastasis or a combination thereof (par. 3, 7, 24, 56-61);
wherein the biomarker is a cancer cell, a cancer stem cell or a cancer initiating cell, one or more extracellular vesicles, a cell-free nucleic acid of cancer, cancer initiating cells (CICs) or cancer stem cells, one or more immune cells (par. 3, 7, 24, 56-61);
[claim 22] wherein, after adding the fluid to the nanosensor, the fluid remains on the nanosensor for an incubation period (par. 78);
[claim 24] wherein providing the cancer assessment includes providing a type of the cancer, a location of the cancer, a stage of the cancer, a metastatic potential of the cancer, or a therapy efficacy of the cancer (par. 13, 16, 24);
[claim 41] wherein providing the cancer assessment includes determining a metastatic state of cancer from a cancer site, the cancer site including lung tissue, breast tissue, colon tissue, kidney tissue, thyroid tissue and skin tissue (par. 50, 56-61);
[claim 52] wherein the sample Raman spectrum includes second amplified signals indicating a presence of a second biomarker on the nanosensor and the method further comprises:
performing further data processing on the sample Raman spectrum to compare the second amplified signals to a second template Raman spectrum to determine a correlation between the sample Raman spectrum and the second template Raman spectrum, the template Raman spectrum being of a known cancer characteristic (par. 10-12, 53, 53, 56-59); and
based on both the correlation between the sample Raman spectrum and the template Raman spectrum and the second correlation between the sample Raman spectrum and the second template Raman spectrum, providing a diagnosis of the cancer in the patient (par. 10-12, 53, 53, 56-59).
Allowable Subject Matter
Claims 55-64 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONATHAN M HANSEN whose telephone number is (571)270-1736. The examiner can normally be reached Monday to Friday, 8am to 4pm.
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JONATHAN M. HANSEN
Primary Examiner
Art Unit 2877
/JONATHAN M HANSEN/Primary Examiner, Art Unit 2877
