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 .
Status of Claims
Applicant's arguments, filed 03/02/2026, have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicants have amended their claims, filed 03/02/2026, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Applicants have amended claims 1 and 15.
Applicants have left claims 4, 6-7, 10-11, 13-14, 18, 20-21, 24-25, and 27-28 as originally filed/previously presented.
Applicants have canceled/previously canceled claims 2-3, 5, 8-9, 12, 16-17, 19, 22-23, and 26.
Claims 1, 4, 6-7, 10-11, 13-15, 18, 20-21, 24-25, and 27-28 are the current claims hereby under examination.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 03/04/2026 is being considered by the examiner.
Claim Rejections - 35 USC § 112(b) - Newly Applied Necessitated by Applicant’s Amendments
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, 4, 6-7, 10-11, 13-15, 18, 20-21, 24-25, and 27-28 are 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.
Regarding claim 1, the claim recites “the signal is indicative of the alcohol level” in line 17. However, claim 1 recites “receive a signal from the in vivo alcohol sensor indicative of an alcohol level” in line 8, and “a signal received from the in vivo alcohol sensor after the initial wear period” in lines 16-17. In light of the specification, it is currently unclear what previously recited signal “the signal” recited in line 17 is referring to. For the purposes of examination, “the signal” recited in line 17 is being interpreted as any signal received from the in vivo alcohol sensor.
The dependent claims of the above rejected claim are rejected due to their dependency.
Regarding claim 15, the claim recites “the signal is indicative of the alcohol level” in lines 15-16. However, claim 15 recites “receiving … a signal from the in vivo alcohol sensor indicative of an alcohol level” in lines 6-7, and “a signal received from the in vivo alcohol sensor after the initial wear period” in lines 14-15. In light of the specification, it is currently unclear what previously recited signal “the signal” recited in line 15 is referring to. For the purposes of examination, “the signal” recited in line 15 is being interpreted as any signal received from the in vivo alcohol sensor.
The dependent claims of the above rejected claim are rejected due to their dependency.
Claim Rejections - 35 USC § 101 - Withdrawn
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.
Response to Arguments
Applicant’s arguments, see pages 7-10 of Remarks, filed 03/02/2026, with respect to claims 1, 4, 6-7, 10-11, 13-15, 18, 20-21, 24-25, and 27-28 have been fully considered and are persuasive. Applicants have amended the independent claims to recite sufficient additional elements and structure to integrate the abstract ideas into a practical application. Further, Applicants arguments regarding implementing the abstract ideas with an in vivo alcohol sensor to account for enzyme degrading is considered persuasive. The 101 rejection of claims 1, 4, 6-7, 10-11, 13-15, 18, 20-21, 24-25, and 27-28 has been withdrawn.
Claim Rejections - 35 USC § 103 - Newly Applied Necessitated by Applicant’s Amendments
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.
Claims 1, 4, 6-7, 10, 13, 15, 18, 20-21, 24, and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Brister et al. (US 20060142651 A1) (previously cited), hereinafter referred to as Brister, in view of Hall et al. (US 20200196921 A1) (previously cited), hereinafter referred to as Hall, in view of Zalevsky et al. (US 20130144137 A1) (previously cited), hereinafter referred to as Zalevsky.
The claims are generally directed towards an apparatus comprising: an in vivo alcohol sensor comprising a portion configured to be positioned in contact with a bodily fluid, wherein the in vivo alcohol sensor is an electrochemical sensor and comprises one or more active areas including an enzyme configured to facilitate detection of alcohol in the bodily fluid; and one or more processors in communication with the in vivo alcohol sensor, wherein the one or more processors are configured to: receive a signal from the in vivo alcohol sensor indicative of an alcohol level; determine a ratio of a peak signal amplitude and a peak signal width of the signal received from the in vivo alcohol sensor during an initial wear period, wherein the peak signal width comprises a time period over which the received signal exceeds a background signal level of the in vivo alcohol sensor, wherein the background signal level is indicative of a noise level; determine a peak signal width of a signal received from the in vivo alcohol sensor after the initial wear period, wherein the signal is indicative of the alcohol level; determine blood alcohol concentration, in part, based on the peak signal width of the signal received after the initial wear period and the ratio; and output an indication of the blood alcohol concentration on a display in communication with the one or more processors.
Regarding claim 1, Brister discloses an apparatus (Abstract, Fig. 2, Fig. 3, Fig. 14A, para. [0006]) comprising:
an in vivo alcohol sensor comprising a portion configured to be positioned in contact with a bodily fluid (para. [0238], “biological sample … blood, interstitial fluid …”, para. [0255-0257], para. [0264], “sensor adapted for transdermal insertion through the skin of a host …”), wherein the in vivo alcohol sensor is an electrochemical sensor and comprises one or more active areas including an enzyme configured to facilitate detection of an analyte in the bodily fluid (Fig. 3, element 32, “sensor”, para. [0302], “window 43 can be formed in the insulator to expose a portion of the working electrode 44 for electrochemical reaction”, para. [0305], “working electrode is configured to measure the concentration of an analyte … enzymatic electrochemical sensor …”, para. [0346], “enzyme domain provides an enzyme to catalyze the reaction of the analyte …”, para. [0197], “analyte … ethanol”); and
one or more processors in communication with the in vivo alcohol sensor (Fig. 2, element 16, Fig. 14A, element 138, para. [0266], “electronics unit … integrated circuit, such as … a microcontroller or a processor”, para. [0469]), wherein the one or more processors are configured to:
receive a signal from the in vivo alcohol sensor indicative of an alcohol level (Fig. 3, element 32, “sensor”, Fig. 5B, para. [0197], “analyte … glucose … ethanol …”, para. [0299], para. [0302-0305], “working electrode 44 is configured to measure the concentration of an analyte …”);
determine a peak signal amplitude of the signal received from the in vivo alcohol sensor during an initial wear period, wherein the peak signal comprises a time period over which the received signal exceeds a background signal level of the in vivo alcohol sensor, wherein the background signal level is indicative of a noise level (para. [0314], “measuring a baseline signal …”, para. [0547-0549], “baseline are tested to determine whether they fall within a predetermined acceptable threshold …”, para. [0554], para. [0564]);
determine a peak signal of a signal received from the in vivo alcohol sensor after the initial wear period, wherein the signal is indicative of the alcohol level (para. [0197], para. [0302-0305], para. [0547], para. [0579], para. [0602]);
determine a concentration, in part, based on the peak signal of the signal received after the initial wear period (para. [0314], “baseline signal can be subtracted …”, para. [0546], “calibration of the resultant difference signal can be performed …”); and
output an indication on a display in communication with the one or more processors (Fig. 14B, Fig. 15, Fig. 16A-D, Fig. 17A-D, para. [0494-502], “sensor electronics … enable measurements of levels of the analyte … enable audible, tactile, or visible communication or display of the sensor data …”).
However, Brister does not explicitly disclose the enzyme is configured to facilitate detection of alcohol, and the indication is of the determined blood alcohol concentration.
Hall teaches of an analogous implantable biosensor for monitoring the concentration of an analyte in a body fluid (Abstract). Hall further teaches receiving a signal from an in vivo alcohol sensor, wherein at least a portion of the in vivo alcohol sensor is positioned in contact with a bodily fluid (Fig. 1A, element 110, para. [0066]), and wherein the in vivo alcohol sensor comprises one or more active areas including an enzyme configured to facilitate detection of alcohol (para. [0066], “multi-electrode electrochemical cell … enzymatic reaction that occurs when alcohol oxidase interacts with ethanol”). Hall further teaches outputting an indication of the blood alcohol concentration (para. [0058], para. [0066]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the analyte sensor and processor disclosed by Brister to explicitly include an enzyme configured to facilitate detection of alcohol to determine blood alcohol concentration, and output the determined blood alcohol concentration, as taught by Hall. This is because Hall teaches that by monitoring ethanol within the interstitial fluids, blood alcohol levels can be determined due to the high correlation (para. [0066]).
However, modified Brister does not explicitly disclose the determined peak signal amplitude is a ratio of the peak signal amplitude and the peak signal width, the determined peak signal after the initial wear period is a peak signal width, and determining blood alcohol concentration based on the peak signal width and the ratio.
Zalevsky teaches an analogous apparatus for monitoring blood alcohol concentration (Abstract, para. [0011]). Zalevsky further teaches when monitoring the blood alcohol concentration, peaks and ratios of peaks and signal widths over time, were selected as parameters when determining blood alcohol concentration (Fig. 11a-11b, Fig. 12, para. [0129-0154). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus taught by modified Brister to explicitly disclose the determined peak signal amplitude is a ratio of the peak signal amplitude and the peak signal width, the determined peak signal after the initial wear period is a peak signal width, and determining blood alcohol concentration based on the peak signal width and the ratio, as taught by Zalevsky. This is because Zalevsky teaches that unlike glucose, alcohol takes time to be absorbed, and by analyzing the peaks and ratios of peaks and signal widths over time, more accurate blood alcohol concentrations can be determined (para. [0130]).
Regarding claim 4, modified Brister discloses the apparatus of claim 1, wherein the initial wear period is 1, 2, 3, 4, or 5 days after insertion of the in vivo alcohol sensor (para. [0564], “waiting a predetermined time period … about 1 day to about five days”).
Regarding claim 6, modified Brister discloses the apparatus of claim 1, wherein the one or more processors are further configured to: determine the blood alcohol concentration based on a sensitivity of the in vivo alcohol sensor (para. [0546], “calibration of the resultant difference signal can be performed …”, para. [0549], para. [0551], “batch of sensors … designed with substantially the same … sensitivity”).
Regarding claim 7, modified Brister discloses the apparatus of claim 6, wherein the sensitivity of the in vivo alcohol sensor is factory set based on a calibration (para. [0551], “designed with substantially the same baseline and/or sensitivity … initial calibration factor can be programmed into the sensor …”).
Regarding claim 10, modified Brister discloses the apparatus of claim 1, wherein the one or more active areas each include one or more enzymes, wherein the one or more enzymes degrade over a life of the in vivo alcohol sensor (para. [0383], “sensor … cellular migration to the sensor and associated degradation”).
Regarding claim 13, modified Brister discloses the apparatus of claim 1, wherein the one or more processors are further configured to: output an alert based on the blood alcohol concentration, wherein the alert is visual, auditory, or vibratory (Fig. 14B, Fig. 15, Fig. 16A-D, Fig. 17A-D, para. [0494-502], “sensor electronics … enable measurements of levels of the analyte … enable audible, tactile, or visible communication or display of the sensor data …”).
Regarding claim 15, Brister discloses a method (Abstract, Fig. 2, Fig. 3, Fig. 14A, para. [0006]) comprising:
detecting a signal by an in vivo alcohol sensor, wherein at least a portion of the in vivo alcohol sensor is positioned in contact with a bodily fluid (para. [0238], “biological sample … blood, interstitial fluid …”, para. [0255-0257], para. [0264], “sensor adapted for transdermal insertion through the skin of a host …”), and wherein the in vivo alcohol sensor is an electrochemical sensor and comprises one or more active areas including an enzyme configured to facilitate detection of an analyte in the bodily fluid (Fig. 3, element 32, “sensor”, para. [0302], “window 43 can be formed in the insulator to expose a portion of the working electrode 44 for electrochemical reaction”, para. [0305], “working electrode is configured to measure the concentration of an analyte … enzymatic electrochemical sensor …”, para. [0346], “enzyme domain provides an enzyme to catalyze the reaction of the analyte …”, para. [0197], “analyte … ethanol”);
receiving, by one or more processors (Fig. 2, element 16, Fig. 14A, element 138, para. [0266], “electronics unit … integrated circuit, such as … a microcontroller or a processor”, para. [0469]), a signal from the in vivo alcohol sensor indicative of an alcohol level (Fig. 3, element 32, “sensor”, Fig. 5B, para. [0197], “analyte … glucose … ethanol …”, para. [0299], para. [0302-0305], “working electrode 44 is configured to measure the concentration of an analyte …”);
determining a peak signal amplitude of the signal received from the in vivo alcohol sensor during an initial wear period, wherein the peak signal comprises a time period over which the received signal exceeds a background signal level of the in vivo alcohol sensor, wherein the background signal level is indicative of a noise level (para. [0314], “measuring a baseline signal …”, para. [0547-0549], “baseline are tested to determine whether they fall within a predetermined acceptable threshold …”, para. [0554], para. [0564]);
determining, by the one or more processors, a peak signal of a signal received from the in vivo alcohol sensor after the initial wear period, wherein the signal is indicative of the alcohol level (para. [0197], para. [0302-0305], para. [0547], para. [0579], para. [0602]);
determining, by the one or more processors, a concentration, in part, based on the peak signal of the signal received after the initial wear period (para. [0314], “baseline signal can be subtracted …”, para. [0546], “calibration of the resultant difference signal can be performed …”); and
displaying a concentration on a display in communication with the one or more processors (Fig. 14B, Fig. 15, Fig. 16A-D, Fig. 17A-D, para. [0494-502], “sensor electronics … enable measurements of levels of the analyte … enable audible, tactile, or visible communication or display of the sensor data …”).
However, Brister does not explicitly disclose an enzyme configured to facilitate detection of alcohol; and the concentration displayed is the blood alcohol concentration.
Hall teaches of an analogous method of using an implantable biosensor for monitoring the concentration of an analyte in a body fluid (Abstract). Hall further teaches receiving a signal from an in vivo alcohol sensor, wherein at least a portion of the in vivo alcohol sensor is positioned in contact with a bodily fluid (Fig. 1A, element 110, para. [0066]), and wherein the in vivo alcohol sensor comprises one or more active areas including an enzyme configured to facilitate detection of alcohol (para. [0066], “multi-electrode electrochemical cell … enzymatic reaction that occurs when alcohol oxidase interacts with ethanol”). Hall further teaches displaying the blood alcohol concentration (para. [0058], para. [0066]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method disclosed by Brister to explicitly include an enzyme configured to facilitate detection of alcohol to determine blood alcohol concentration, and display the determined blood alcohol concentration, as taught by Hall. This is because Hall teaches that by monitoring ethanol within the interstitial fluids, blood alcohol levels can be determined due to the high correlation (para. [0066]).
However, modified Brister does not explicitly disclose the determined peak signal amplitude is a ratio of the peak signal amplitude and the peak signal width, the determined peak signal after the initial wear period is a peak signal width, and determining blood alcohol concentration based on the peak signal width and the ratio.
Zalevsky teaches an analogous method for monitoring blood alcohol concentration (Abstract, para. [0011]). Zalevsky further teaches when monitoring the blood alcohol concentration, peaks and ratios of peaks and signal widths over time, were selected as parameters when determining blood alcohol concentration (Fig. 11a-11b, Fig. 12, para. [0129-0154). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method taught by modified Brister to explicitly disclose the determined peak signal amplitude is a ratio of the peak signal amplitude and the peak signal width, the determined peak signal after the initial wear period is a peak signal width, and determining blood alcohol concentration based on the peak signal width and the ratio, as taught by Zalevsky. This is because Zalevsky teaches that unlike glucose, alcohol takes time to be absorbed, and by analyzing the peaks and ratios of peaks and signal widths over time, more accurate blood alcohol concentrations can be determined (para. [0130]).
Regarding claim 18, modified Brister discloses the method of claim 15, wherein the initial wear period is 1, 2, 3, 4, or 5 days after insertion of the in vivo alcohol sensor (para. [0564], “waiting a predetermined time period … about 1 day to about five days”).
Regarding claim 20, modified Brister discloses the method of claim 15, further comprising: determining the blood alcohol concentration based on a sensitivity of the in vivo alcohol sensor (para. [0546], “calibration of the resultant difference signal can be performed …”, para. [0549], para. [0551], “batch of sensors … designed with substantially the same … sensitivity”).
Regarding claim 21, modified Brister discloses the method of claim 20, wherein the sensitivity of the in vivo alcohol sensor is factory set based on a calibration (para. [0551], “designed with substantially the same baseline and/or sensitivity … initial calibration factor can be programmed into the sensor …”).
Regarding claim 24, modified Brister discloses the method of claim 15, wherein the one or more active areas include one or more enzymes, wherein the one or more enzymes degrade over a life of the in vivo alcohol sensor (para. [0383], “sensor … cellular migration to the sensor and associated degradation”).
Regarding claim 27, modified Brister discloses the method of claim 15, further comprising: outputting an alert based on the blood alcohol concentration, wherein the alert is visual, auditory, or vibratory (Fig. 14B, Fig. 15, Fig. 16A-D, Fig. 17A-D, para. [0494-502], “sensor electronics … enable measurements of levels of the analyte … enable audible, tactile, or visible communication or display of the sensor data …”).
Claims 11 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Brister et al. (US 20060142651 A1) (previously cited), hereinafter referred to as Brister, in view of Hall et al. (US 20200196921 A1) (previously cited), hereinafter referred to as Hall, in view of Zalevsky et al. (US 20130144137 A1) (previously cited), hereinafter referred to as Zalevsky as applied to claims 1 and 15 above, and further in view of Simpson et al. (US 20110028816 A1) (previously cited), hereinafter referred to as Simpson.
Regarding claim 11, modified Brister discloses the apparatus of claim 1.
However, modified Brister does not explicitly disclose wherein the one or more active areas of the in vivo alcohol sensor detect two or more analytes, wherein the two or more analytes include ethanol, glucose, or lactate.
Simpson teaches of an analogous analyte sensor and method for detection of an analyte (Abstract, para. [0356]). Simpson teaches the sensor generates a signal, wherein at least a portion of the analyte sensor is positioned in contact with a bodily fluid (Fig. 1F, para. [0362]). Simpson further teaches the one or more active areas of the analyte sensor detect two or more analytes, wherein the two or more analytes include ethanol, glucose, or lactate (para. [0432], “sensor having an additional electrode … expose working electrodes 112, 122 …”, para, [0437], “multiple working electrodes can allow for measurements of multiple analytes …”, para. [0328], “analyte … glucose … lactate … ethanol”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus taught by modified Brister to include more than one active area of the in vivo alcohol sensor to detect two or more analytes, wherein the two or more analytes include ethanol, glucose, or lactate, as taught by Simpson. This is because Simpson teaches measuring more than one analyte at a time with multiple electrodes allows for more accurate measurements or allow for detection of conditions that can affect sensor accuracy (para. [0437]).
Regarding claim 25, modified Brister discloses the method of claim 15.
However, modified Brister does not explicitly disclose wherein the one or more active areas of the in vivo alcohol sensor detect two or more analytes, wherein the two or more analytes include ethanol, glucose, or lactate.
Simpson teaches of an analogous analyte sensor and method for detection of an analyte (Abstract, para. [0356]). Simpson teaches the sensor generates a signal, wherein at least a portion of the analyte sensor is positioned in contact with a bodily fluid (Fig. 1F, para. [0362]). Simpson further teaches the one or more active areas of the analyte sensor detect two or more analytes, wherein the two or more analytes include ethanol, glucose, or lactate (para. [0432], “sensor having an additional electrode … expose working electrodes 112, 122 …”, para, [0437], “multiple working electrodes can allow for measurements of multiple analytes …”, para. [0328], “analyte … glucose … lactate … ethanol”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method taught by modified Brister to include more than one active area of the in vivo alcohol sensor to detect two or more analytes, wherein the two or more analytes include ethanol, glucose, or lactate, as taught by Simpson. This is because Simpson teaches measuring more than one analyte at a time with multiple electrodes allows for more accurate measurements or allow for detection of conditions that can affect sensor accuracy (para. [0437]).
Claims 14 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Brister et al. (US 20060142651 A1) (previously cited), hereinafter referred to as Brister, in view of Hall et al. (US 20200196921 A1) (previously cited), hereinafter referred to as Hall, in view of Zalevsky et al. (US 20130144137 A1) (previously cited), hereinafter referred to as Zalevsky as applied to claims 13 and 27 above, and further in view of Rauchenzauner et al. (“Disturbances of electrolytes and blood chemistry in acute alcohol intoxication”) (previously cited).
Regarding claim 14, modified Brister discloses the apparatus of claim 13.
However, modified Brister does not explicitly disclose wherein the alert comprises a recommendation to consume an oral electrolyte solution.
Rauchenzauner teaches that disturbances of electrolytes are reported in associated with alcoholism (pg. 84, left col., para. 2). Rauchenzauner teaches that in acute alcohol intoxication patients, the most common electrolyte disturbance was hyponatremia, which is when too little salt is in the blood (pg. 85, right col., para. 2). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the alert taught by modified Brister to explicitly be a recommendation to consume an oral electrolyte solution, as taught by Rauchenzauner. This is because Rauchenzauner teaches that the most common electrolyte imbalance of acute alcoholism is where the blood has too little salt, and an alert to consume an oral electrolyte solution would allow the user to return to a normal electrolyte level (pg. 85, right col., para. 2).
Regarding claim 28, modified Brister discloses the method of claim 27.
However, modified Brister does not explicitly disclose wherein the alert comprises a recommendation to consume an oral electrolyte solution.
Rauchenzauner teaches that disturbances of electrolytes are reported in associated with alcoholism (pg. 84, left col., para. 2). Rauchenzauner teaches that in acute alcohol intoxication patients, the most common electrolyte disturbance was hyponatremia, which is when too little salt is in the blood (pg. 85, right col., para. 2). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the alert taught by modified Brister to explicitly be a recommendation to consume an oral electrolyte solution, as taught by Rauchenzauner. This is because Rauchenzauner teaches that the most common electrolyte imbalance of acute alcoholism is where the blood has too little salt, and an alert to consume an oral electrolyte solution would allow the user to return to a normal electrolyte level (pg. 85, right col., para. 2).
Response to Arguments
Applicant's arguments filed 03/02/2026 have been fully considered but they are not persuasive.
Applicants have argued on pages 10-12 of Remarks, filed 03/02/2026, that “the methods to estimate a BAC level from using an electrical current from an in vivo electrochemical alcohol sensor bear no technical relationship to the optical speckle-based vibration detection methods described in Zalevsky … Zalevsky analyzes an entirely different type of signal and does not relate to analyzing a signal from an in vivo alcohol sensor … Zalevsky does not specifically disclose or suggest determining blood alcohol concentration based in part on a ratio of peak signal amplitude to peak signal width …”.
In response to applicant's argument that Zalevsky is nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, Zalevsky is in the same field of endeavor regarding blood alcohol concentration monitoring.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Specifically, as reiterated above, Brister in view of Hall teach utilizing an in vivo alcohol sensor comprising an enzyme to determine blood alcohol concentration. In the same field of endeavor regarding blood alcohol concentration monitoring, Zalevsky teaches determining peaks and ratios of peaks and signal widths over time when determining blood alcohol concentration to account for alcohol absorption. One of ordinary skill in the art would recognize the peaks and ratios of peaks taught by Zalevsky would improve the signal processing taught by modified Brister in a similar manner.
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 KYLE W KRETZER whose telephone number is (571)272-1907. The examiner can normally be reached Monday through Friday 8:30 AM to 5:30 PM.
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, Jason M Sims can be reached at (571)272-7540. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/K.W.K./Examiner, Art Unit 3791
/JASON M SIMS/Supervisory Patent Examiner, Art Unit 3791
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