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 § 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 1-11 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.
The claims are indefinite because the metes and bounds of the “first index value,” “second index value,” and “supporting information” are not reasonably clear, and because the claims recite functional result-oriented language without providing objective boundaries for how the values are determined or how the generated information is distinguished from any other analytical output.
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 1-2 and 5-11 are rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
The claims are directed to the abstract idea of obtaining biomarker information, calculating index values based on the biomarker amounts, and generating information that supports a determination of cognitive impairment, cognitive decline, or risk thereof. More particularly, the claims recite steps of receiving biomarker data, determining a first index value and a second index value from that data, and generating or outputting information based on the calculated index values. Such operations constitute data collection, analysis, and reporting, which may be performed mentally or with pen and paper and thus recite an abstract idea. See Parker v. Flook, 437 U.S. 584 (1978); Electric Power Group, LLC v. Alstom S.A., 830 F.3d 1350 (Fed. Cir. 2016). To the extent the biomarker measurements are correlated with cognitive impairment or decline, the claims also implicate a natural law or natural correlation, and merely applying that relationship through conventional calculation and reporting does not render the claims eligible. See Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66 (2012).
The claims do not integrate the judicial exception into a practical application. The additional recited elements, including an information processing device, a biomarker quantification system, a liquid chromatography mass spectrometer, and proteolytic degradation treatment, are recited at a high level of generality and merely apply the abstract idea in a routine laboratory and computing environment. These elements do not improve the functioning of a computer or any other technology, do not effect a transformation sufficient to confer eligibility, and do not otherwise impose meaningful limits on the judicial exception. See Alice Corp. v. CLS Bank Int’l, 573 U.S. 208 (2014); MPEP § 2106.05. Moreover, the claims do not recite an inventive concept because the additional elements, considered individually and as an ordered combination, amount only to conventional biomarker testing and generic data processing steps. Accordingly, the claims fail to recite patent-eligible subject matter under 35 U.S.C. 101.
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.
Claim(s) 1 and 7-11 are rejected under 35 U.S.C. 103 as being unpatentable over Federoff, Howard J. (US-20180149665-A1)
As per claims 1, 7 and 11, Federoff discloses a method, device and system, the method comprising:
-A determination supporting information generating method [0002], [0006], [0011]
-Calculating based on amounts of two or more biomarkers contained in a biological sample derived from a human [0002], [0006], [0011], [0030], [0036]
-First index value indicating presence or absence of cognitive impairment or cognitive decline [0002], [0006], [0014], [0037], [0039], [0044]
-Second index value indicating degree of progression of cognitive impairment or cognitive decline [0014] (PADI as likelihood/progression-related stratification), [0037], [0047]
-Generating information that supports determination of cognitive impairment, cognitive decline, or risk thereof [0002], [0006], [0011], [0045], [0046], [0047]
This is found to be obviousness (rather than anticipation per se) because the exact phrase “first index value” and “second index value” is not used in the excerpts, but the concept of a scoring/valuation system is supported by PADI in [0014] and by the metabolite profile comparisons in [0037]-[0039].
The combination of metabolite profile scoring/comparison plus PADI stratification fairly suggest the method / device / system.
As per claims 8-10, Federoff references measurement techniques such as mass spectroscopy, HPLC, ELISA, etc. [0036]
Conclusion
Eyk teaches methods and kits for diagnosis and prognosis using biomarkers comprising albumin-bound protein/peptide complex (ABPPC).
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/MICHAEL FUELLING/ Supervisory Patent Examiner
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