DETAILED ACTION
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 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea (e.g. mathematical concepts) without significantly more. MPEP 2106 (III) provides the flow chart for determining whether a claim is subject matter eligible.
The broadest reasonable interpretation of claim 1 is as follows (citations taken from the instant application):
A method of determining a calibration model for an analytical instrument (analytical instrument such as mass spectrometers are commonly calibrated, see paragraph [0003] – however not significantly more as directed towards well understood routine and conventional activity, see paragraph [0003]), the method comprising:
receiving mass spectral data, wherein the mass spectral data is generated by analyzing one or more calibration samples using an analytical instrument (generating mass spectral data by analyzing one or more samples, suitable calibration samples and analytical samples are known in the art, see paragraph [0041] – however not significantly more as directed towards well understood routine and conventional activity);
processing the mass spectral data to produce processed data indicative of one or more properties of the analytical instrument (processing the mass spectral data to produce processed data indicative of one or more properties of the analytical instrument may comprise generating single ion area data by determining the area of each ion peak in response to detecting the plurality of single ions, see paragraph [0044] – however not significantly more than a field of use for a step of data gathering); and
determining a calibration model for the analytical instrument by performing Gaussian Process Regression (GPR) on the processed data (the step of determining a calibration for the analytical instrument may comprise determining a correction function by performing Gaussian Process Regression on the data, see paragraphs [0044-0045]; the GPR being expressed by the function provided, for example, in paragraph [0185]. This step is an abstract idea (e.g. mathematical concept) done on a processor, see MPEP 2104(a)).
The abstract ideas (e.g. mathematical concepts and data manipulation) are not integrated into a practical application because the relationship to the components and operation of the analytical instrument and the processor do not add significantly more.
The generating and receiving of mass spectral data and subsequent data manipulation is a field of use for a step of data gathering. MPEP 2106.05(h) states “Another consideration when determining whether a claim integrates the judicial exception into a practical application in Step 2A Prong Two or recites significantly more than a judicial exception in Step 2B is whether the additional elements amount to more than generally linking the use of a judicial exception to a particular technological environment or field of use. As explained by the Supreme Court, a claim directed to a judicial exception cannot be made eligible "simply by having the applicant acquiesce to limiting the reach of the patent for the formula to a particular technological use." Diamond v. Diehr, 450 U.S. 175, 192 n.14, 209 USPQ 1, 10 n. 14 (1981). Thus, limitations that amount to merely indicating a field of use or technological environment in which to apply a judicial exception do not amount to significantly more than the exception itself, and cannot integrate a judicial exception into a practical application.” Here, the generation of mass spectral data by an analytical instrument is well-understood, routine, and conventional as known in the art in paragraph [0041] of the instant specification.
Processing the mass spectral data to produce processed data is a step of data gathering. MPEP 2106.05(b)(III) recites “Use of a machine that contributes only nominally or insignificantly to the execution of the claimed method (e.g., in a data gather step or in a field-of-use limitation) would not integrate a judicial exception or provide significantly more.” Here, a step of processing data is incidental to the primary process of determining a calibration model via the claimed mathematical concepts.
Determining a calibration model by performing GPR on the processed data do not add significantly more because the abstract ideas does nothing to change or improve the analytical instrument. MPEP 2106.05(c) states “An "article" includes a physical object or substance. The physical object or substance must be particular, meaning it can be specifically identified. "Transformation" of an article means that the "article" has changed to a different state or thing. Changing to a different state or thing usually means more than simply using an article or changing the location of an article. A new or different function or use can be evidence that an article has been transformed. Purely mental processes in which thoughts or human based actions are "changed" are not considered an eligible transformation. For data, mere "manipulation of basic mathematical constructs [i.e.,] the paradigmatic ‘abstract idea,’" has not been deemed a transformation. CyberSource v. Retail Decisions, 654 F.3d 1366, 1372 n.2, 99 USPQ2d 1690, 1695 n.2 (Fed. Cir. 2011) (quoting In re Warmerdam, 33 F.3d 1354, 1355, 1360, 31 USPQ2d 1754, 1755, 1759 (Fed. Cir. 1994)).” Here, the application of the GPR algorithm is merely data manipulation of the mass spectral data and does not result in a significant transformation.
The dependent claims do not rectify the above issues. Claims 2-20 further recite limitations regarding field of use of the analytical instrument and data manipulation of the mass spectral data without adding significantly more and therefore are not patent eligible under 35 USC 101.
Conclusion
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Hanway Chang
/HC/ Examiner, Art Unit 2878
/GEORGIA Y EPPS/ Supervisory Patent Examiner, Art Unit 2878
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