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Claims 12, 14-16, 18, 19 and 22-26 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected method, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 06 MARCH 2026.
Applicant’s election without traverse of Group I: Claims 1-6 and 9-11 in the reply filed on 06 MARCH 2026 is acknowledged.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 04 AUGUST 2023 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 09 APRIL 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 13 FEBRUARY 2025 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 2026 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.
Drawings
The drawings are objected to because in some of the Figures, the words are extremely blurry, Figure 2, 5, 9C, 13A, 13B, 16A, 16B, 17. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
Claim 6 is 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.
It is unclear to the Examiner to which ‘the analyte’ is referring back to in claim 1; the ‘first plurality of analytes’ or the ‘second plurality of analytes’?
For examination purpose, ‘the analyte’ can refer to either the ‘first’ or ‘second’ plurality of analytes.
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 claimed invention is directed to an abstract idea without significantly more. The claim(s) recite(s) method for identifying a biomarker associated with a disease state, the method comprising: (a) isolating a first plurality of analytes in a first biological sample of an individual known to have the disease state using an electrode array configured to generate an AC dielectrophoretic field; (b) isolating a second plurality of analytes in a second biological sample of a healthy individual using an electrode array configured to generate an AC dielectrophoretic field; and (c) identifying a subset of the first plurality of analytes, wherein the subset is quantitatively different in the first biological sample compared with the second biological sample, wherein the subset is identified as associated with the disease state.
This judicial exception is not integrated into a practical application because step ( c) is a process that under its broadest reasonable interpretation, covers performance of the limitation in the mind. The step of ‘identifying’ can be done with the human mind/eyes and/or by reading a table. In addition, the step of ‘identifying’ is at a high-level of generality such that it amount to insignificant presolution activity, e.g. mere data gathering is necessary to use to re-assess. Since it is claimed at a high level of generality, there is no meaningful limitation claimed, such as a particular or unconventional machine or transformation of a particular article.
Accordingly, this additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception. All the claimed steps are well understood routine and convention. As discussed above with respect to the integration of the abstract idea into a practical application, the addition element of identifying and wherein the subset is identified as associated with the disease state amounts to no more than mere instructions to applying the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept.
The claim is ineligible / not patent eligible.
Dependent Claim 2 and 3 only define what is being done in the isolating step. These isolating steps do not include elements which amount to significantly more. These steps are found in the prior art.
Dependent Claims 4-5 attempts to further define the identifying steps. These steps are n not considered an addition element that amounts to significantly more as Claim 4 only defines a technique which is well known in the art for isolating cancer cells and Claim 5 defines a quantifying step which is WURC.
Dependent Claim 6 only defines the type of analyte to be detected. This is not considered an addition element that amounts to significantly more. In addition, the fact that Claim 1 is directed to a biological sample it will inherently have any one of a protein, a polypeptide, a nucleic acid, an exosome, or a combination thereof and it is merely a design choice of the experiment to isolate a particular analyte as a design choice of the method.
Dependent Claim 9 only defines the technique in which is to be used. This technique is WURC and is not considered an addition element that amounts to significantly more.
Dependent Claims 10 and 11 only defines the disease state and the type of cancer the method is to be applied in identifying. The disease state and type cancer is not considered an addition element that amounts to significantly more.
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.
(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.
Claims 1-3, 5, 6, and 10-11 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by KRISHNAN, WO 2019/126388 A1, submitted on the Information Disclosure Statement on 04 AUGUST 2023, Foreign Patent Documents Cite No. 027.
Applicant’s invention is directed towards a method.
Regarding Claim 1, the reference KRISHNAN discloses a method for identifying a biomarker associated with a disease state, abstract, [0003], the method comprising:
(a) isolating a first plurality of analytes in a first biological sample of an individual known to have the disease state using an electrode array configured to generate an AC dielectrophoretic field, [0050, 00123-00131], Example 6, [00224-00226];
(b) isolating a second plurality of analytes in a second biological sample of a healthy individual using an electrode array configured to generate an AC dielectrophoretic field, [0050, 00123-00131], Example 6, [00224-00226]; and
(c) identifying a subset of the first plurality of analytes, wherein the subset is quantitatively different in the first biological sample compared with the second biological sample, wherein the subset is identified as associated with the disease state, Figure 10, [0225], Claims 1-10.
Additional Disclosures Included are: Claim 2: wherein the method of claim 1, wherein isolating comprises using electrodes configured to generate a dielectrophoretic low field region and a dielectrophoretic high field region, [0005, 0014, 0058], Claims 29 and 30 ; Claim 3: wherein the method of claim 1, wherein isolating comprises capturing the first plurality of analytes or the second plurality of analytes on one or more electrode, [0065]. ; Claim 5: wherein the method of claim 1, wherein identifying the subset comprises quantifying each of the first plurality of analytes and the second plurality of analytes, Claims 1, 6 and 15, [0007, 0009, 0035], ; Claim 6: wherein the method of claim 1, wherein the analyte comprises a protein, a polypeptide, a nucleic acid, an exosome, or a combination thereof, [0004, 0035, 0037], Claim 1 and 7. ; Claim 10:wherein the method of claim 1, wherein the disease state is a cancer, a neurological disease, an infection, or an inflammatory disease, [0025-0029, 0036, 0223-0225]. ; Claim 11: wherein the method of claim 9, wherein the cancer is a pancreatic cancer, an ovarian cancer, a bladder cancer, a colorectal cancer, a lung cancer, a brain cancer, a prostate cancer, a breast cancer, a skin cancer, a lymphoma, a tongue cancer, a mouth cancer, a pharynx cancer, an oral cavity cancer, an esophagus cancer, a stomach cancer, a small intestine cancer, a colon cancer, a rectum cancer, an anal cancer, an anorectum cancer, a liver cancer, an intrahepatic bile duct cancer, a gallbladder cancer, a biliary cancer, a digestive organ cancer, a larynx cancer, a bronchus cancer, a respiratory organ cancer, a bone cancer, a joint cancer, a soft tissue cancer, a heart cancer, a melanoma, a nonepithelial skin cancer, a uterine cancer, a cervical cancer, a vulva cancer, a vagina cancer, a penis cancer, a genital cancer, a testis cancer, a kidney cancer, a renal pelvis cancer, a ureter cancer, a urinary organ cancer, an eye cancer, an orbit cancer, a nervous system cancer, an endocrine cancer, a thyroid cancer, a Hodgkin lymphoma, a non-Hodgkin lymphoma, a myeloma, an acute lymphocytic leukemia, a chronic lymphocytic leukemia, an acute myeloid leukemia, a chronic myeloid leukemia, or a leukemia, [0025-0029, 0223-0225].
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 4 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over KRISHNAN, WO 2019/126388 A1, submitted on the Information Disclosure Statement on 04 AUGUST 2023, Foreign Patent Documents Cite No. 027, as applied to claim 1 above, and further in view of WANG, Cancer Biol Ther. 2009 June ; 8(12): 1083–1094.
Regarding Claim 4, the KRISHNAN reference discloses the claimed invention, but is silent in regards to wherein identifying the subset comprises mass spectrometry analysis of the first plurality of analytes and the second plurality of analytes.
The WANG reference discloses a method for identifying a biomarker associated with a disease state, abstract, page 1, Introduction the method comprising:
(a) isolating a plurality of analytes in a first biological sample of an individual known to have the disease state, page 2, Biomarkers in Tissue and Plasma, and
(c) identifying a subset of the plurality of analytes, wherein identifying the subset comprises mass spectrometry analysis of the plurality of analytes, page 4, Different Modes of Mass Spectrometry, page 5-6, Is the Candidate Protein Biomarker….
17. It would be obvious to one having ordinary skill in the art before the effective filing date to modify the claimed invention of KRISHNAN with the identifying technique of mass spectrometry to identify analytes of cancer as taught by WANG to multiplex hundreds of assay using microliter quantities and eliminate interfering antibodies, WANG page 6.
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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