DETAILED ACTION
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, 3, 5, and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhbanov et al. (“Electrochemical impedance spectroscopy of blood for sensitive detection of blood hematocrit, sedimentation and dielectric properties”) in view of Sato et al. (USP #8,466,694) and further in view of Paul et al. (USP #10,718,728).
As to claim 1, Zhbanov teaches a method comprising: measuring an impedance of a fluid to be analyzed based on the measured voltage (p3303 – two planar electrodes at the bottom of a PDMS chamber); modeling the measured impedance using an equivalent circuit that comprises a capacitor representing a parasitic component and a constant phase element representing a polarization effect (p3304 – the stray capacitance is noted as the parasitic circuit element; p3306 – equivalent circuit; p3305 – the total impedance measured using the two-electrode configuration is composed of the polarization impedance, the impedance of the liquid, and the impedance of the stray capacitance. The polarization impedance behavior is characterized by using a constant phase element), wherein the modeling of the measured impedance comprises reducing an effect of noise from the measured impedance by eliminating the parasitic capacitance and the polarization effect from the equivalent circuit (p3307 – to correct the polarization effect and the stray capacitance, the lumped elements CPEb and Cs were excluded from the electrical circuit shown in Fig. 6D; p3308 – this allowed the correction of the polarization effect and exclusion of the stray capacitance); and analyzing the blood component based on modeling the measured impedance using the equivalent circuit (p3310 – after elimination of the parameters previously mentioned, the other parameters are used to determine hematocrit levels).
Zhbanov fails to expressly teach that the fluid to be analyzed in vivo, in which the impedance of the fluid is measured within the body of the subject, and applying a current to a first electrode and a second electrode of an impedance sensor; measuring a voltage between the first electrode and the second electrode based on applying the current.
Sato teaches a biometric measurement device for determining the level of hematocrit in vivo (Abstract) in which an equivalent circuit is used (col. 4 lines 1-15). Paul teaches an impedance sensor for blood using an equivalent circuit (Fig. 2-3; col. 4 lines 27-34), applying a current to a first electrode and a second electrode of an impedance sensor; measuring a voltage between the first electrode and the second electrode based on applying the current (col. 9 lines 13-21). It would have been obvious to modify Zhbanov with Sato to make the measurements without the need for an intrusive and potentially painful sample extraction, and further with Paul to utilize known measurement techniques to obtain the impedance measurement as it would be obvious to try.
As to claim 3, Zhbanov teaches the modeling of the measured impedance using the equivalent circuit comprises extracting one or more parameters, related to properties of the fluid to be analyzed, based on the modeling the equivalent circuit (Table 4).
As to claim 5, Paul teaches that the technique can be used to monitor levels of other parameters such as cholesterol, proteins, and glucose (col. 6 line 52 to col. 7 line 20). It would have been obvious to modify the above combination further with Paul to utilize the technique in assessing various types of analytes to increase the utility of the device.
As to claim 8, Zhbanov teaches the parasitic component is previously measured using a substance other than the fluid to be analyzed (p3304 – stray capacitance measured using air and de-ionized water; and the value derived of 1.018 pF was used as a fixed constant – Table 4). While Zhbanov fails to expressly teach performing this calibration on an in vivo sensor, it would have been obvious to modify the above combination further to utilize this measurement, as it was considered to be “independent of the properties of the liquid filling the chamber” (p3304), which would make it a fixed property of the sensor that can be reused for every subsequent measurement. Since it is not practical for blood to be removed from electrodes to obtain a blank reading (as well as perhaps defeating the purpose of making such an in vivo measurement), it would have been obvious to utilize this measurement made from a substance other than the fluid to be analyzed.
Claim(s) 4 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhbanov et al. (“Electrochemical impedance spectroscopy of blood for sensitive detection of blood hematocrit, sedimentation and dielectric properties”), Sato et al. (USP #8,466,694), and Paul et al. (USP #10,718,728), and further in view of Caduff et al. (“Non-invasive glucose monitoring in patients with diabetes: A novel system based on impedance spectroscopy”).
As to claim 4, while Zhbanov teaches tracking the changes in the parameters of blood impedance from earlier values (Table 5), it does not expressly teach obtaining a parameter variation by normalizing the extracted one or more parameters using a parameter at a reference time. Caduff teaches this limitation, disclosing an impedance-spectroscopy system for glucose monitoring in which the measured response is referenced to a per-subject baseline, and in which deviation from that baseline is applied to a model to yield the estimate (p601; Equation 2). It would have been obvious to modify the above combination with Caduff to cancel out any subject and session specific offsets, which would yield a more predictable result.
As to claim 9, the above combination fails to expressly teach that the reference time corresponds to a fasting interval. Caduff teaches measurements taken at various states, including one during a fasting state (p601). It would have been obvious to modify the above combination with Caduff to utilize measurements from similar states for comparative purposes in which the user’s state with respect to meals aren’t a confounding variable for more consistent results.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhbanov et al. (“Electrochemical impedance spectroscopy of blood for sensitive detection of blood hematocrit, sedimentation and dielectric properties”), Sato et al. (USP #8,466,694), and Paul et al. (USP #10,718,728), and further in view of Blank et al. (USP #7,509,153).
As to claim 6, the above combination fails to expressly teach adjusting at least one of a temperature and a flow property of the fluid to be analyzed. Blank teaches a device for measuring glucose indirectly from tissue and controlling a parameter such as skin temperature, which also directly affects perfusion (Abstract), which would allow better measurement of any analytes carried by blood. Accordingly, it would have been obvious to modify the above combination with Blank to adjust the temperature and/or the flow property of the fluid to be analyzed.
Response to Arguments
Applicant’s arguments have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 CHRISTIAN JANG whose telephone number is (571)270-3820. The examiner can normally be reached Monday-Friday (7-3:30 EST).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Chen can be reached at 571-272-3672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
CHRISTIAN JANG
Primary Examiner
Art Unit 3791
/CHRISTIAN JANG/ Primary Examiner, Art Unit 3791 8/11/26
