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 .
Status of Claims
The claim set submitted on 03 AUGUST 2026 is acknowledged and considered. In the claim set, Claims 1, 6 and 9 are ‘Currently Amended’; Claims 2, 3, 10 and 11 are ‘Original’; Claims 5, 7, 8, 13, 17 and 20-21 are ‘Cancelled’; Claims 12, 14, 15, 16, 18, 19, 22-26 are ‘Withdrawn’.
Current pending claims are Claims 1-4, 6 and 9-11 and are considered on the merits below.
Response to Amendment/Arguments
Applicant’s arguments, see REMARKS, filed 03 AUGUST 2026, with respect to the objection to the drawings and the 112(b) rejection have been fully considered and are persuasive. The objection to the drawings and the 112(b) rejection has been withdrawn.
Applicant's arguments filed 03 AUGUST 2026 have been fully considered but they are not persuasive.
In regards to Applicant’s assertion to the 101 rejection, Applicant asserts that under Step 2A, Prong Two, since the claimed steps, in particular the isolating and the quantifying steps are tied to physical laboratory workflow that cannot be reduced to merely data analysis process; this is not persuasive.
Under Step 2A, Prong Two, the eligibility of the claim as a whole under this step and prong, is whether any additional steps within the claim, including each of steps (a)-(d) transform the claim into something that integrates the abstract idea into a practical application of the abstract idea. While steps (a) and (b) are physical steps these data gathering (pre-solution activity), which is not a particular practical application (MPEP 2106.05(g)). These steps are recited at a high level of generality such that it amount to insignificant presolution activity, e.g. mere data gathering is necessary to use to analyze (compare). 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.
Steps (c ) and (d) , directed to ‘quantifying’ and ‘identifying (and then comparing)’ are abstract ideas, i.e. math or mental steps.
The additional step of identifying in claim 4 is considered to be well understood routine and convention in analyte analysis.
With respect to Step 2B: Applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references.
In addition: Applicant's arguments do not comply with 37 CFR 1.111(c) because they do not clearly point out the patentable novelty which he or she thinks the claims present in view of the state of the art disclosed by the references cited or the objections made. Further, they do not show how the amendments avoid such references or objections.
With respect to the art rejections, based on Applicant’s amendments, the grounds of rejection for the pending claims are modified compared to the previous action due to the amendments but rely on the same prior art.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 03 AUGUST 2026 was filed after the mailing date of the Non-Final Office Action on 01 APRIL 2026. 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 the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-4, 6, 9, 10 and 11 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Newly amended Claim 1 recites in step (d) the identifying step that “at least one analyte was not previously known to be a biomarker for the disease state”. This language is not supported by the original disclosure.
While there is a discussion on previously known markers in [00203] for multi-cancer assays, there is no discussion about “not previously known” or “unknown” biomarkers for cancer.
Dependent claims follow the same reasoning.
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 11 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.
Claim 11 recites the limitation "the cancer" in line 1. There is insufficient antecedent basis for this limitation in the claim. The first instance “a cancer” is found in Claim 10.
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 discovering 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) quantifying each of the first plurality of analytes and the second plurality of analytes; (d) identifying at least one analyte comprised in the first plurality of analytes and/or the second plurality of analytes, that is quantitatively different in the first biological sample compared with the second biological sample, wherein the at least one analyte was not previously known to be a biomarker for the disease state
This judicial exception is not integrated into a practical application because step ( c-d) is a process that under its broadest reasonable interpretation, covers performance of the limitation in the mind. The steps of ‘quantifying’ and ‘identifying’ can be done with the human mind/eyes and/or by reading a table. In addition, the steps of ‘quantifying’ and ‘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.
Eligibility of the claim as a whole under this step2A and prong two, is whether any additional steps within the claim, including each of steps (a)-(d) transform the claim into something that integrates the abstract idea into a practical application of the abstract idea. While steps (a) and (b) are physical steps these data gathering (pre-solution activity), which is not a particular practical application (MPEP 2106.05(g)). These steps are recited at a high level of generality such that it amount to insignificant presolution activity, e.g. mere data gathering is necessary to use to analyze (compare). 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.
Steps (c ) and (d) , directed to ‘quantifying’ and ‘identifying (and then comparing)’ are abstract ideas, i.e. math or mental steps.
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 quantifying and identifying and wherein the analyte 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 Claim 4 attempts to further define the identifying steps. This steps is 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.
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, 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, [0007, 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, [0007, 00224-00226]; and
(c) quantifying each of the first plurality of analytes and the second plurality of analytes, [0007, 0009, 0037], Claims 1, 7-10;
(d) identifying at least one analyte comprised in the first plurality of analytes and/or the second plurality of analytes, that is quantitatively different in the first biological sample compared with the second biological sample, wherein the at least one analyte was not previously known to be a biomarker for the disease state
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 6: wherein the method of claim 1, wherein the first plurality of analytes and the second plurality of analytes each 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 Claims 4 and 9, the KRISHNAN reference discloses the claimed invention, but is silent in regards to wherein identifying the at least one analyte comprises mass spectrometry analysis of the first plurality of analytes and the second plurality of analytes.
The WANG reference discloses a method for discovering 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) quantifying each of the first plurality of analytes, page 4, Different Modes of Mass Spectrometry, page 5-6, Is the Candidate Protein Biomarker….;
(d) identifying at least one analyte comprised in the first plurality of analytes that is quantitatively different in the first biological sample compared with the second biological sample, wherein the at least one analyte was not previously known to be a biomarker for the disease state
10. 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
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.
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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CTM
/CHRISTINE T MUI/Primary Examiner, Art Unit 1797
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