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 .
Claim(s) 1-8, 10, 15, 18-22, 24, 41 and 52-54 are rejected under 35 U.S.C. 103.
Claim Objections
Claim 54 is objected to under 37 CFR 1.75(c) as being in improper form because it is a multiple dependent claim. See MPEP § 608.01(n).
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.
Claim(s) 1-8, 10, 15, 18-22, 24, 41 and 52-54 are rejected under 35 U.S.C. 103 as being unpatentable over US Publication 2023/0123746 to Im et al. in view of US Publication 2017/0020460 to Leblond et al.
In regards to claims 1-8, 10, 15, 18-22, 24, 41 and 52-54, Im discloses and shows in Figures 1-24, a system and method of providing a cancer assessment for a patient, 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. 4, 8, 12, 47);
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 during Raman spectroscopy (par. 4, 6-8, 12, 26-29);
performing Raman spectroscopy on the volume of fluid 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, 32);
and
based on the detected one or more cancer characteristics, providing the cancer assessment of the patient (par. 4, 6-8, 12, 16);
[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 (Figures 6a-g) (par. 81, 192, 198);
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 (Figures 6a-g) (par. 81, 192, 198);
[claim 6] wherein the cancer characteristic is a cancer type, a cancer stage, cancer metastasis, cancer potential for metastasis or a combination thereof (par. 4, 12, 22, 118);
[claim 7] wherein the biomarker is a cancer cell, a cancer stem cell or a cancer initiating cell (par. 4, 12, 22, 118);
[claim 8] wherein the biomarker is one or more extracellular vesicles (par. 4, 12, 22, 118);
[claim 10] wherein the biomarker is a cell-free nucleic acid of cancer, cancer initiating cells (CICs) or cancer stem cells (par. 4, 12, 22, 118);
[claim 15] wherein the biomarker is one or more immune cells (par. 4, 12, 14, 22, 118);
[claim 18] wherein the fluid is obtained by density gradient centrifugation (par. 143, 234).
[claim 22] wherein, after adding the fluid to the nanosensor, the fluid remains on the nanosensor for an incubation period (par. 130, 179, 234, 240-241);
[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. 4, 12, 22, 118);
[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. 4, 12, 22, 47-49, 118);
[claim 52] wherein the sample Raman spectrum includes second amplified signals indicating a presence of a second biomarker on the nanosensor (par. 22, 56, 62-63, 96, 215) (Figures 14a-f).
Im differs from the limitations in that it is silent to the system and method further comprising:
[claims 1 and 53] processing the sample Raman spectrum using data from template Raman spectra from known cancer samples having cancer characteristics to detect whether the sample comprises one or more of the cancer characteristics;
[claim 3] 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;
[claim 4] wherein the feature extraction is performed using Principal Component Analysis, Multivariate Curve Resolution Analysis or a combination thereof;
[claim 5] wherein 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;
[claim 52] 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, 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.
However, Leblond teaches and shows in Figures 1-3, a system and method for assessing cancer status of biological samples, wherein a Raman spectrometer obtains real-time tissue classification by obtaining Raman spectra from in vivo samples, wherein the system utilizes “a boosted tree classification algorithm” to compare a plurality of values obtained from the real-time Raman spectra with a plurality of reference spectra for various reference biological tissues (par. 6, 8-13, 18-19, 97-99). Further, Leblond teaches “a variety of classification algorithms” for analyzing the Raman spectra, including principal component analysis (PCA) and “support vector machines, linear discriminant analysis and artificial neural networks”, which provide “superior performance overall” (par. 92, 100, 171, 175, 178).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention, to modify Im to include the reference signal comparison and classification algorithms discussed above for the advantage of reducing processing time and providing real-time tissue classification, with a reasonable expectation of success.
In regards to claim 2, Im in view of Leblond, differ from the limitations in that they are silent to the method: 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.
However, correlation and threshold values are well-known to those of ordinary skill in the art.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention, to modify Im in view of Leblond, to include the correlations and thresholds discussed above for the advantage of utilizing well-known data processing methods to obtain a desired or optimum system configuration, with a reasonable expectation of success.
In regards to claims 19-21, Im in view of Leblond, differ from the method:
[claim 19] wherein the volume of fluid is about 10 µL or more;
[claim 20] wherein the fluid is blood plasma and the volume of the blood plasma is about 10 µL or more; and
[claim 21] wherein the fluid is buffy coat and the volume of the buffy coat is about 10 µL or more.
However, it has been held that finding the optimal or working ranges of a variable involves only routine skill in the art (MPEP 2144.05). In re Aller, 105 USPQ 233. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980). Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382.
Further, a mere change in size or design choice of a component is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention, to modify Im in view of Leblond, to include the sample quantity discussed above for the advantage of obtaining a desired or optimum system configuration, with a reasonable expectation of success.
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.
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, Michelle Iacoletti can be reached at 571-270-5789. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
JONATHAN M. HANSEN
Primary Examiner
Art Unit 2877
/JONATHAN M HANSEN/Primary Examiner, Art Unit 2877