DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Arguments
Applicant’s arguments with respect to claim(s) 6-19 have been considered but are moot because the new ground of rejection does not rely on the combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
The Examiner notes that the rejections under 35 U.S.C. 112(a) and (b) have been removed as the amendments to the claims have overcome the rejections. With respect to the rejection under 35 U.S.C. 103, the Examiner contends that the amended claims do not overcome the teachings of the cited prior art. Applicant has argued that reference to Brauker et al., do not meet the limitations of adjusting an analyte concentration function such that a factory calibration parameter is updated. First, the Examiner notes that the claimed analyte concentration function is sufficiently broad so as to read on any measurement of an analyte. Second, the Examiner contends that any change and/or update in calibration of a reader can be reasonably construed as updating a calibration parameter. Given this view, the Examiner contends that the teachings of measuring an analyte and adjusting a factory calibration taught by Brauker et al., meets the limitations. In addition to the factory calibration, Brauker et al., also teach periodic baseline calibration, clinical calibration, and oxygen calibration, all of which can be considered as updating a factory calibration parameter. Therefore, in light of the teachings of the prior art, and the arguments presented here, the Examiner contends that the limitations of the instant claims are taught by the cited prior art, thus the rejection is maintained.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 6-18 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Handique et al., (US 2002/0143437) in view of Brauker et al., (US 2005/0203360).
Regarding claims 6, 7, and 9-11, Handique et al., teach methods and systems for control of microfluidic devices comprising a fluidic device having inlets (sample collection unit, paragraph 0070, figure 1 inlets 1 and 2), a reaction/detection assembly (assay assembly, paragraph 0070, figure 1 reaction/detection) for detecting the presence of an analyte in a bodily fluid (paragraph 0192), and a user level (reader assembly, paragraphs 0106, 0107, figure 2 #18) for monitoring and interpreting reaction data. Handique et al., also teach temperature and pressure sensors for detecting changes in temperature and/or pressure and communicating said changes to the user level and adjusting the parameters by which the system operates (paragraphs 0146, 0148, 0154, 0175). Handique et al., do not teach adjusting an analyte function such that a factory calibration parameter of the reader assembly is updated.
Brauker et al., teach signal processing for a continuous analyte sensor wherein the sensor can be calibrated based on a constant analyte (analyte function, paragraph 0231) and adjusting a factory calibration (paragraph 0231). The Examiner is reading this combination as applying a known technique to a known method to yield predictable results which would have been obvious to one of ordinary skill in the art (MPEP 2141 III D). Reference to Brauker et al., teach updating a factory calibration based on an analyte function, thus one of ordinary skill in the art would have found it obvious to utilize the calibration of Brauker et al., with the process of Handique et al., to calibrate a reader assembly. Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Handique et al., with the calibration technique taught by Brauker et al., as applying a known technique to a known method to yield predictable results requires only routine skill in the art.
Regarding claims 8, 12, 14 and 15, Handique et al., teach temperature and pressure sensors coupled both the fluidic device and reader assembly (paragraphs 0146, 0148, 0154, 0175).
Regarding claims 13 and 17, Handique et al., teach the sensors communicating wirelessly to an external device (paragraph 0123).
Regarding claim 16, Handique et al., teach a calibration step of the sensor circuitry (paragraph 0143) which is being read on the claimed adjusting a calibration step.
Regarding claim 18, Handique et al., teach detecting the presence of a microdroplet (paragraph 0148) which is being read on the claimed presence of moisture.
Claim 19 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Handique et al., (US 2002/0143437) in view of Brauker et al., (US 2005/0203360) as applied to claim 18 above, and further in view of Patel (US 2003/0211618).
Regarding claim 19, Handique et al., in view of Brauker et al., do not teach a sensor comprising thiocyanate and iron salts.
Patel teaches a color changing steam indicator wherein the indicator comprises thiocyanates and iron salts (paragraph 0075). Patel teaches that it is advantageous to utilize thiocyanates and iron salts as a means of providing an indicator that is stable under ambient conditions, but undergoes a color change when treated with humidity or steam (paragraphs 0071, 0075).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Handique et al., in view of Brauker et al., to utilize thiocyanate and iron salts in order to provide an indicator that is stable under ambient conditions and undergoes a color change when treated with humidity or steam as taught by Patel.
Conclusion
THIS ACTION IS MADE FINAL. 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 DWAN A GERIDO whose telephone number is (571)270-3714. The examiner can normally be reached Mon-Fri 10-6.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lyle Alexander can be reached at (571) 272-1254. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DWAN A GERIDO/Examiner, Art Unit 1797 /LYLE ALEXANDER/Supervisory Patent Examiner, Art Unit 1797