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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Objections
Claim 29 is objected to because of the following informalities:
Claim 29 is objected to because the lengthy enumeration of Nephelometric Turbidity Unit (NTU) values renders the claim cumbersome and difficult to evaluate. Applicant is required to present the turbidity limitation in a more concise form. For purposes of examination, the claim will be treated as best understood.
The claims have not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the claims.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
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.
Claim(s) 1-11, 16-17, 21-26, 29 and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Heise et al. (1998) “Multivariate calibration for near-infrared spectroscopic assays of blood substrate in human plasma based on variable selection using PLS regression vector choices.” in view of Nakajima (U.S. Patent Application Publication 20100068746).
As per claim 1, Heise et al. disclose a method comprising:
applying a light source in the near-infrared spectrum to a test sample (Experimental Section; Fig. 1A; Fig. 1B);
measuring reflectance, transmission, or transflectance of the test sample over a range of near-infrared wavelengths, thereby generating test wavelength spectra (Experimental Section; Fig. 1A; Fig. 1B), and
comparing the test wavelength spectra with reference wavelength spectra obtained from reference samples having known concentrations of the analyte, to determine the concentration of the analyte in the sample (Abstract; Table 1; Figs. 3-8).
Heise et al. do not explicitly disclose a test sample obtained from processing of blood-derived plasma.
Nakajima teaches a blood-derived sample, wherein the term blood derived sample encompasses a serum sample separated from a blood sample and prepared and measuring concentration of a component contained in the blood-derived sample ¶¶ [0010]; [0067])
It would have been obvious however, to one of ordinary skill in the art at the time of the invention to apply the analyte concentration determination technique taught by Heise to a test sample obtained from processing of blood-derived plasma as taught by Nakajima in order to determine analyte concentration in blood-derived samples.
As per claim 4, Heise et al. disclose a method comprising:
providing training samples, wherein the samples have known concentrations of the analyte (Abstract; Table 1; Figs. 3-8);
applying a light source in the near-infrared spectrum to the training samples (Experimental Section; Fig. 1A; Fig. 1B);
measuring the reflectance, transmission, or transflectance of the training samples over a range of near-infrared wavelengths, thereby generating training wavelength spectra (Experimental Section; Fig. 1A; Fig. 1B);
selecting spectral regions of interest in the training wavelength spectra (Fig. 4); and
generating a model by applying multivariate analysis to the spectra to provide a correlation with known concentration of the analyte (Abstract; Table 1; Fig. 4; Figs. 3-8).
Heise et al. do not explicitly disclose providing training samples obtained from processing blood-derived plasma.
Nakajima teaches a blood-derived sample, wherein the term blood derived sample encompasses a serum sample separated from a blood sample and prepared and measuring concentration of a component contained in the blood-derived sample ¶¶ [0010]; [0067])
It would have been obvious however, to one of ordinary skill in the art at the time of the invention to provide training samples obtained from processing of blood-derived plasma as taught by Nakajima for the use in the model generation technique taught by Heise et al. in order to generate a model for determining analyte concentration in blood-derived samples.
Claims 2, 3 and 5-8 further recite: subjecting test wavelength spectra to multivariate data analysis, comparing the test wavelength spectra to a model generated using multivariate analysis, employing particular multivariate analysis techniques, generating a model using PLS regression, evaluating the model using statistical parameters, and applying spectral pretreatment to the wavelength spectra.
It would have been obvious to one of ordinary skill in the art at the time of the invention to employ known multivariate analysis techniques, calibration models, model evaluation parameters, and spectral pretreatment techniques in the analyte concentration determination method taught by Heise et al. to develop and optimize analyte concentration models.
Claims 9-11 further recite: first derivative and/or vector normalization spectral pretreatment, transflectance measurement, and application of near-infrared light using a probe.
It would have been obvious to one of ordinary skill in the art at the time of the invention to employ known spectral preprocessing techniques and known near-infrared sampling arrangements to improve spectral acquisition.
Claims 16, 17, and 19 further recite: determining concentrations of particular analytes and determining protein concentration using a Dumas assay.
It would have been obvious to one of ordinary skill in the art at the time of the invention to apply the analyte concentration determination technique taught by Heise et al. to particular analytes and to utilize known reference assay techniques for obtaining analyte concentration values used in model generation and analyte determination.
Claims 21-26 further recite: particular blood-derived plasma materials, including human plasma, cryo-poor plasma, cryo-rich plasma, pooled plasma, hyperimmune plasma, precipitate resuspensions, and plasma fractions.
It would have been obvious to one of ordinary skill in the art at the time of the invention to apply the analyte concentration determination technique taught by Heise et al. to known plasma-derived materials, plasma-processing products, and plasma fractions because such materials are suitable for compositional and analyte concentration analysis.
Claim 29 recites a turbid solution or suspension having specified turbidity values.
It would have been obvious to one of ordinary skill in the art at the time of the invention to perform the analyte concentration determination method taught by Heise et al. on samples exhibiting varying turbidity levels.
Claim 32 recites performing the method in-line, at-line, off-line, or on-line.
It would have been obvious to one of ordinary skill in the art at the time of the invention to perform the analyte concentration determination method taught by Heise et al. in-line, at-line, off-line, or on-line depending upon the desired measurement location and process integration requirements.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to COURTNEY D THOMAS whose telephone number is (571)272-2496. The examiner can normally be reached M-F: 9 AM - 5 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Makiya can be reached at 571-272-2273. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/COURTNEY D THOMAS/Primary Examiner, Art Unit 2884
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