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 .
Election/Restrictions
Claims 33, 34, 39, 42 and 43 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected kit and chip, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 22 JULY 2026.
Applicant’s election without traverse of Group I: Claims 1, 3,5 6, 12, 13, 15, 17, 19, 21, 23, 25 and 27-31 in the reply filed on 22 JULY 2026 is acknowledged.
Withdrawn claim have been ‘Cancelled’.
Status of Claims
Applicant has elected Group I: Claims 1, 3,5 6, 12, 13, 15, 17, 19, 21, 23, 25 and 27-31 in the reply filed on 22 JULY 2026.
Claims 2, 4, 7-11, 14, 16, 18, 20, 22, 24, 26 and 32-43 are ‘Cancel’.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 04 MARCH 2024 was filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
The information disclosure statement (IDS) submitted on 06 MARCH 2024 was filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
The information disclosure statement (IDS) submitted on 04 DECEMBER 2024 was filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
Claims 5, 6, 12, 13, 15, 17, 19, 21, 23, 25, 27, 28, 29 and 31 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claims 5, 6, 28, 29, 31, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claims 28, 29 and 31, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 12, the claim recites an ‘and/or’ conjunction. It is unclear whether both elements are required, whether only one is required, or whether any combination is intended.
Claims 13, 15, 17, 19, 21, 23, 25, 27, 28, 29, and 30 are also rejected under 112b as being dependent upon a rejected claim under 112b.
Claim Interpretation
Claims 5, 6, 12 and 29 recites the language using the conjunction of “and/or”. It is interpreted by the Examiner that in the instance of “and/or”; the conjunction of “or” is selected and whatever element that is recited in that claim element; only the dependent claim upon that element is selected.
For instance , in Claim 5 if element 5) is selected; none of the other alternative are selected. In addition, in Claim 12, if element a) is selected; none of the other alternative are selected and only the claim dependent upon 12a) is performed. All other claims dependent upon 12b)-h) are not selected, Claims 15, 17, 19, 21, 23, 25, and 27 are not possible.
In all instance of ‘and/or’ it is interpreted that only one is required and no combination is intended.
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.
Claims 1, 3, 5, 6, 12, 13, 15, 17, 19, 21, 23, 25 and 27-31 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
The claim(s) recite(s) a method of assessing whether an individual has colorectal cancer (CRC) or is at risk of developing CRC, the method comprising:1) providing a sample of microvesicles (MVs) which have been obtained from the plasma of the individual;2) determining the concentration of MVs in the individual's plasma; and3) classifying the individual as having benign colorectal polyps (BCRPs) or CRC when the concentration of MVs in the individual's plasma is statistically significantly higher compared to control.
In Claim 1, steps 2 and 3, ‘determining’ and ‘classifying’ are considered to be abstract ideas, which are steps that can be performed using the human mind and pen/paper. In addition, these steps can be performed simply by observation and noting (i.e. classifying and comparing) whether or not the value is statistically significant. MPEP 2106.04(a)(2)(III).
In addition, Claim 5 recites a ‘determining’ and ‘classifying’ steps which are steps that can be performed using the human mind and pen/paper.
This judicial exception is not integrated into a practical application because after the classifying step is performed; nothing else is done. All the steps in claim 1, prior to determining is merely a data gathering step and all the other pending claims directed to sensitivity or specificity, specific markers, providing of blood to determine a specific concentration, techniques for analysis do not add any additional steps which integrates the abstract idea into a practical application of the abstract idea. Any parameters or data gathering steps do not impart any significance to the abstract idea, nor the claims when viewed as a whole.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims steps and elements which are all well understood routine and conventional.
Claims 3, 5, 6, 12, 13, 15, 17, 19, 21, 23, 25 and 27 recites providing a blood sample where a specific biomarker is detect/determine which is merely a design choice of the experiment linking biomarkers to the disease. In addition, the limitations of recitation the ROC sensitivity and the specificity is to provide limitations (or a threshold) which do not add any practical application to the method nor provides any additional limitation which is significantly more. In the art of analyte analysis, it is known in the art to compare to a threshold or provide limitations on biomarkers or analytes to determine the statistical significance of a biomarker.
Claims 28-31 merely recite characterization techniques which are known in the art of analyte analysis.
Claim Rejections - 35 USC § 102
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 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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 5 and 31 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by HUBER, submitted on the Information Disclosure Statement on 04 MARCH 2024; Non-Patent Literature Documents Cite No. 13.
Applicant’s invention is directed towards a method .
Regarding Claim 1, the HUBER reference discloses a method of assessing whether an individual has colorectal cancer (CRC) or is at risk of developing CRC, the method comprising:1) providing a sample of microvesicles (MVs) which have been obtained from the plasma of the individual, page 1797, Materials and Methods, Colorectal Cancer Lines,…; 2) determining the concentration of MVs in the individual's plasma, page 1797, Materials and Methods, Colorectal Cancer Lines,…; and Western Blotting; and 3) classifying the individual as having benign colorectal polyps (BCRPs) or CRC when the concentration of MVs in the individual's plasma is statistically significantly higher compared to control, page 1797-1798, Analysis of Apoptotic Activity, Figure 1, page 1800, Detection of Proapoptotic Microvesicles….
Additional Disclosures Included are: Claim 5: wherein the method according to claim 1, further comprising: 4) determining the concentration of MVs in the individual's plasma which test positive for the detectable expression, preferably surface expression, of one or more biomarkers; and 5) classifying the individual as having BCRPs or CRC when the concentration of biomarker positive MVs in the individual's plasma is statistically significantly higher compared to control and/or when the concentration of biomarker positive MVs in the individual's plasma exceeds a threshold value, page 1797-1800, Analysis of Apoptotic Activity, Modified Carcinoembryonic…, Detection of Proapoptotic Microvesicles…; and Claim 31: wherein the method according to claim 1, wherein MVs are detected via an immunoassay, preferably an enzyme-linked immunosorbent assay (ELISA); or via a cytometry assay, such as a mass cytometry assay or a flow cytometry assay; or by a mass spectrometry assay; preferably MVs are detected via a flow cytometry assay, preferably using an anti-annexin V antibody conjugated to a fluorophore such as fluorescein isothiocyanate (FITC), page 1797-1798, Antibodies and Flow Cytometry, Immunocytochemistry…, abstract.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 3, 6, 12 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over HUBER, submitted on the Information Disclosure Statement on 04 MARCH 2024; Non-Patent Literature Documents Cite No. 13.
Regarding Claim 3 , the HUBER reference discloses the claimed invention, but is silent in regards to the specific plasma concentration of MVs is 144 MVs/mL or more the individual is identified as having BCRPs or CRC, and wherein the method has a receiver operating characteristics (ROC) sensitivity of 100% and a specificity of 59%; or when the plasma concentration of MVs is 244 MVs/mL or more the individual is identified as having BCRPs or CRC, and wherein the method has a ROC sensitivity of 100% and a specificity of 93%.
HUBER teaches CEA measurement in CRC patients were performed in addition to cells and microvesicles were quantified, page 1797, Antibodies and Flow Cytometry, Western Blotting. HUBER also discloses and teaches expression of other markers in CRC ad health patients were documented, abstract.
While HUBER does not specifically teach concentrations of receiver operating characteristics (ROC) sensitivity and a specificity, it would be obvious to one having ordinary skill in the art before the effective filing date to modify the claimed invention to have a receiver operating characteristics (ROC) sensitivity at 100% to correctly identify a true positive case and the higher the sensitivity with a ROC at 100% will correctly identify more true positives and true negatives in the population across a range of thresholds.
Regarding Claim 6, the HUBER reference discloses the claimed invention including wherein: 6) the one or more biomarkers comprises CEA, and wherein the individual is classified as having CRC when the concentration of MVs which test positive for the detectable expression of CEA exceeds a threshold value, page 1798-1799, Detection of Proapoptotic…, but is silent in regard to wherein the method has a ROC sensitivity of 100% and a specificity of 60% or more, preferably wherein the threshold value is 10 MVs/mL or more.
HUBER teaches CEA measurement in CRC patients were performed in addition to cells and microvesicles were quantified, page 1797, Antibodies and Flow Cytometry, Western Blotting. HUBER also discloses and teaches expression of other markers in CRC ad health patients were documented, abstract.
While HUBER does not specifically teach concentrations of receiver operating characteristics (ROC) sensitivity and a specificity, it would be obvious to one having ordinary skill in the art before the effective filing date to modify the claimed invention to have a receiver operating characteristics (ROC) sensitivity at 100% to correctly identify a true positive case and the higher the sensitivity with a ROC at 100% will correctly identify more true positives and true negatives in the population across a range of thresholds.
Regarding Claim 12 , the HUBER reference discloses the claimed invention, including wherein the method further comprising: (a) providing a sample of blood which has been obtained from the individual, determining the concentration of a protein in the individual's blood and classifying the individual as having CRC when the concentration of the protein is below or above, such as in the case of CEA, a threshold value, wherein the protein is haemoglobin, page 1797, Colorectal Cancer Lines, ….; but is silent in regards to a ROC sensitivity of 68% or more and a specificity of 100%, page 1797, Colorectal Cancer Lines, ….
While HUBER does not specifically teach concentrations of receiver operating characteristics (ROC) sensitivity and a specificity, it would be obvious to one having ordinary skill in the art before the effective filing date to modify the claimed invention to have a receiver operating characteristics (ROC) sensitivity at lower rate with a high specificity obtain few false negative, i.e. rarely misses true positive and creating a plot that prioritized avoiding false alarms over catching all cases.
and/or (b) providing a sample of blood which has been obtained from the individual, determining the concentration of a blood cell type in the individual's blood and classifying the individual as having CRC when the concentration of the blood cell type is above a threshold value, wherein the blood cell type is neutrophils and wherein the method has a ROC sensitivity of 47% or more and a specificity of 100%; and/or (c) providing a sample of blood which has been obtained from the individual, determining the concentration of a blood cell type in the individual's blood and classifying the individual as having CRC when the concentration of the blood cell type is below a threshold value, wherein the blood cell type is lymphocytes and wherein the method has a ROC sensitivity of 47% or more and a specificity of 100%; and/or (d) providing a sample of blood which has been obtained from the individual, determining the concentration of a protein in the individual's blood and classifying the individual as having CRC when the concentration of the protein is below a threshold value, wherein the protein is albumen and wherein the method has a ROC sensitivity of 63% or more and a specificity of 100%; and/or (e) providing a sample of blood which has been obtained from the individual, determining the concentration of a protein in the individual's blood and classifying the individual as having CRC when the concentration of the protein is above a threshold value, wherein the protein is C-reactive protein (CRP) and wherein the method has a ROC sensitivity of 63% or more and a specificity of 100%; and/or (f) providing a sample of blood which has been obtained from the individual, determining the concentration of a compound in the individual's blood and classifying the individual as having CRC when the concentration of the compound is below a threshold value, wherein the compound is urea and wherein the method has a ROC sensitivity of 58% or more and a specificity of 100%; and/or (g) providing a sample of blood which has been obtained from the individual, determining the concentration of a compound in the individual's blood and classifying the individual as having CRC when the concentration of the compound is below a threshold value, wherein the compound is creatinine and wherein the method has a ROC sensitivity of 53% or more and a specificity of 100%; and/or (h) providing a sample of blood which has been obtained from the individual, determining the concentration of MVs in the plasma of the individual which test positive for the detectable expression of a protein and classifying the individual as having CRC when the concentration of MVs positive for the protein in the plasma is above a threshold value, wherein the protein is carcinoembryonic antigen (CEA) and wherein the method has a ROC sensitivity of 25% or more and a specificity of 100%. ;
Regarding Claim 13, the HUBER reference discloses the claimed invention, but is silent in regards to the specific method according to claim 12(a), wherein the individual is distinguished as having CRC rather than BCRPs when the concentration of haemoglobin is 133 g/L or less, and wherein the method has a ROC sensitivity of 58.3% or more and a specificity of 90% or more; or wherein the individual is classified as having CRC when the concentration of haemoglobin is 124.5 g/L or less, and wherein the method has a ROC sensitivity of 68% or more and a specificity of 100%.
HUBER teaches CEA measurement in CRC patients were performed in addition to cells and microvesicles were quantified, page 1797, Antibodies and Flow Cytometry, Western Blotting. HUBER also discloses and teaches expression of other markers in CRC ad health patients were documented, abstract.
While HUBER does not specifically teach concentrations of receiver operating characteristics (ROC) sensitivity and a specificity, it would be obvious to one having ordinary skill in the art before the effective filing date to modify the claimed invention to have a receiver operating characteristics (ROC) sensitivity at lower rate with a high specificity obtain few false negative, i.e. rarely misses true positive and creating a plot that prioritized avoiding false alarms over catching all cases.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINE T MUI whose telephone number is (571)270-3243. The examiner can normally be reached M-Th 5:30 -15:30 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, LYLE ALEXANDER can be reached at (571) 272-1254. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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CTM
/CHRISTINE T MUI/Primary Examiner, Art Unit 1797
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