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 .
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 1-9 are rejected under 35 U.S.C. 101 because the claimed invention is directed to abstract idea without significantly more.
Subject Matter Eligibility - Step 1:
Claims 1-9 are rejected under 35 U.S.C. 101 because the claimed invention is directed to abstract idea without significantly more. The claim recites a series of steps or acts, including determining concentration of at least one biomarker in a non-invasive sample. Thus, the claim is directed to a process, which is one of the statutory categories of invention.
Subject Matter Eligibility - Step 2A, Prong 1:
Regarding claim 1, the step of "determining that the at least one biomarker is indicative of lack of health" is a step describing a correlation or relationship between the presence of a biomarker in a sample and a lack of health. This limitation sets forth a judicial exception, because this type of correlation is a consequence of natural processes, similar to the naturally occurring correlation found to be a law of nature by the Supreme Court in Mayo). The step could be performed by a human using mental steps or basic critical thinking, which are types of activities that have been found by the courts to represent abstract ideas (e.g., the mental comparison in Ambry Genetics, or the diagnosing an abnormal condition by performing clinical tests and thinking about the results in Grams). Thus, the claim is directed to at least one exception, which may be termed a law of nature, an abstract idea, or both. Note that although the claim recites several nature-based product limitations (e.g., the sample and biomarker), the claim as a whole is focused on a process of detecting whether the biomarker is present in a sample, and is not focused on the products per se.
Regarding claims 2-9, the correlation is not resolved, because the limitations describe the type of data gathering that does not resolve step 2A prong 1 as correlation as a consequence of the natural process.
Subject Matter Eligibility - Step 2A, Prong 2:
This judicial exception is not integrated into a practical application because the step of "Introducing a sample into a well" and "capturing the at least one biomarker" is merely linking the abstract idea to the field of endeavor and would not be considered a particular practical application (MPEP 2106.05(h)). The claim as a whole is analyzed to determine whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception. Besides the law of nature, the claim recites additional steps of introducing a sample and capturing the biomarker, and the implied step of determining the concentration of the biomarker. Introducing a sample in order to perform tests is well-understood, routine and conventional activity for those in the field of diagnostics. Further, the step is recited at a high level of generality such that it amounts to insignificant presolution activity, e.g., a mere data gathering step necessary to use the correlation. Capturing and implied detecting of the biomarker merely instructs a scientist to use any detection technique. When recited at this high level of generality, there is no meaningful limitation, such as a particular or unconventional machine or a transformation of a particular article, in this step that distinguishes it from well- understood, routine, and conventional data gathering activity engaged in by scientists prior to applicant’s invention, and at the time the application was filed, e.g., the routine and conventional techniques of detecting a protein using an antibody to that protein. Further, it is well established that the mere physical or tangible nature of additional elements such as the obtaining and detecting steps does not automatically confer eligibility on a claim directed to an abstract idea (see, e.g., Alice Corp. v. CLS Bank Int’l, 134 S.Ct. 2347, 2358-59 (2014)). Therefore the limitation is not considered a particular practical application (MPEP 2106.05(h)).
Regarding claims 2-9, there is not significantly more than the exception because the limitations describe the mere data gathering that does not resolve step 2A prong 2.
Subject Matter Eligibility - Step 2B:
The claims 1-9 do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the introducing and capturing biomarker steps are the other elements. Introducing, capturing, and measuring biomarkers are well understood and conventional as evidenced by Pugia et al (US 20070020683) (see rejection below). The claim is therefore not patent eligible.
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 9 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 claim 9, the phrase "like" 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).
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)(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) 1-9 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Pugia et al (US 20070020683).
Regarding claim 1, Pugia et al teach a method of determining concentration of at least one biomarker in a non-invasive sample (Para. 0024: urine, saliva) comprising: introducing a sample into a well, wherein the sample comprises at least one biomarker (Para. 0064-0065: urine samples introduced to wells); capturing the at least one biomarker (Para. 0065: UTI-antibody complex); and determining that the at least one biomarker is indicative of lack of health (Para. 0097: correlate the UTI with disease associated with the measured UTIs).
Regarding claim 2, Pugia et al teach further comprising determining concentration of the at least one biomarker indicating non-invasive sample volume and comparing the concentration of the at least one biomarker to a normal range (Para. 0051: Compared to healthy controls).
Regarding claim 3, Pugia et al teach a concentration of a first biomarker is corrected by a concentration of a second biomarker to as to rates of excretion of the first biomarker (Para. 0067: correction by subtraction of the pro-inhibitor).
Regarding claim 4, Pugia et al teach concentrations of the first or second biomarkers outside of the normal concentration range are used to indicate a disease (Para. 0097: correlate the UTI with disease associated with the measured UTIs) .
Regarding claim 5, Pugia et al teach the sample is chosen from a group comprising human serum albumin, hydroxynonnel to human serum albumin, malondialedehyde to human serum albumin, uristatin, or bikunin. (Para. 0020: Uristatin, Bikunin, Human Serum Albumin).
Regarding claim 6, Pugia et al teach determining a concentration of the biomarker, wherein a concentration of albumin indicates the concentration of the biomarker (Para. 0020: Human Serum Albumin).
Regarding claim 7, Pugia et al teach concentrations of the first or second biomarkers inside of the normal concentration range are used to indicate lack of disease or health. (Para. 0097: correlate the UTI with disease associated with the measured UTIs).
Regarding claim 8, Pugia et al teach the concentrations of the first or second biomarkers inside of the normal concentration range are used to indicate a degree of health or progression to disease. (Para. 0097: correlate the UTI with disease associated with the measured UTIs) .
Regarding claim 9, Pugia et al teach determining a concentration of the biomarker in non-invasive sample fluids, like urine, saliva tears, sweat, nasal lavage, interstitial fluid, and other samples, are used to estimate the biomarker concentrations in the blood without having to directly sample blood (Para. 0053, 0064-0065: urine for allowing non-invasive sampling).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DENNIS MICHAEL WHITE whose telephone number is (571)270-3747. The examiner can normally be reached M-F 8:30am-5pm.
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/Dennis White/Primary Examiner, Art Unit 1758