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 .
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) 18, 20-24, 26-30 and 32-35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pronovost et al. US 2001/0023324 in view of Wang et al. US 2008/0026473 and Kong et al. "New faces of porous Prussian Blue: interfacial assembly of integrated hetero-structures for sensing applications".
Regarding claims 18, 24 and 30, Pronovost discloses a non-invasive biosensor device for detecting a concentration of glucose in saliva ([¶54] saliva sensor), the biosensor comprising:
a substrate ([FIG13] PVC card);
a plurality of electrodes disposed on the substrate ([¶94][FIG.13] multiple electrodes), and
a filter layer positioned on the active layer and configured to separate a predetermined material from the sample of saliva ([¶85,94][FIG13] membrane layers are positioned on the active layer and electrodes and those membranes can be filters or act as filters)
wherein the biosensor device is a non-implantable strip, which is configured to be detachably and electrically coupled to an electronic device ([¶21] test strip is associated with a reader device) that:
wherein a measurement value based on the electric current in the electronic device proportionally corresponds to the concentration of glucose in the saliva ([¶58,68,92] the current is indicative of the glucose and saliva can be tested).
Pronovost does not specifically disclose the electrodes have two portions or that an active layer disposed on the first portion of each of the plurality of electrodes and configured to receive a sample of the saliva, the active layer comprising a porous nanostructure and an enzyme selected to detect glucose in the saliva applied on the active layer. Wang teaches a similar glucose sensor that has electrodes with distinct portions ([FIG8] coated portion is at the bottom second portion is the top) and an active layer ([¶98-101] porous metallic nano structure is used with an enzyme for sensing). Pronovost discloses the test strip causes an electrochemical reaction but does not disclose applying a voltage and measuring a current. Wang teaches the sensor applies a voltage to the second portion of each of the plurality of electrodes, thereby inducing an electrochemical reaction with the glucose in the saliva, the nanostructure and the enzyme ([¶30,35,58] a charge is applied to the electrode and the current is measured from the reaction); and receives an electric current generated by the electrochemical reaction through the second portion of each of the plurality of electrodes in the biosensor device ([¶30,35,58] a charge is applied to the electrode and the current is measured from the reaction). Therefore, it would have been obvious to one of ordinary skill in the art prior to the time of filing to combine the device of Pronovost with the teachings of Wang as Pronovost discloses a meter device and Wang provides such a meter and it is no more than combining prior art elements according to know methods to yield the predictable result of reading sensor glucose reactions.
Pronovost does not specifically disclose wherein the porous metalorganic nanostructure comprises a chemical composition with at least one metal element and a limit for detecting the concentration of glucose in the saliva ranges from 1 µM to 10 µM with respect to the measurement value based on the electric current in the electronic device. Kong teaches a similar analyte sensor that has a second layer that is a metal organic solid structure and the nanostructure has a chemical composition, Ma(II)M'b(III)(CN)6, and M and M' are metal elements ([pgs. 8008-8009] iron hexacyanoferrate is used on electrodes as a detecting layer). Therefore it would have been obvious to one of ordinary skill in the art prior to the time of filing to combine the device of Pronovost with the teachings of Kong in order to have increased detection sensitivity and stability ([pg. 8012]).
Regarding claims 20, 26 and 32, Kong teaches the nanostructure comprises a chemical composition of M(II)M'(III)(CN)6, and wherein M and M' are any one of metal elements selected from the group consisting of Fe, Zn, K, Mg, Al, Cu, Co, Ni, Cr, Mn and Rb ([pgs. 8008-8009] iron hexacyanoferrate is used on the electrode).
Regarding claims 21, 27 and 33, Kong teaches the limit for detecting the concentration of glucose in the saliva is correlated to the nanostructure in the biosensor device ([pgs. 8008-8009] nano iron hexacyanoferrate is used on the electrode. According to the current specification at ¶70 the structure of the iron hexacyanoferrate is what enables the sensitivity of 1-10 µM so Pushpala teaches this limitation as well).
Regarding claims 22, 28 and 34, Kong teaches the limit for detecting the concentration of glucose in the saliva corresponds to a sensitivity for detecting the concentration of glucose in the saliva ([pgs. 8008-8009] iron hexacyanoferrate is used on the electrode. And Wang teaches sensing in saliva).
Regarding claim 23, 29 and 35, Pushpala teaches the measurement value based on the electric current in the electronic device increases as the concentration of glucose in the saliva increases beyond 10 µM ([pg. 8000,8009] the current change corresponds to changes in glucose concentration and [¶36,38] iron hexacyanoferrate is used on the electrode).
Response to Arguments
Applicant's arguments filed 3/17/26 have been fully considered but they are not persuasive.
Regarding Applicant’s argument that Pronovost does not disclose a filter that is positioned on the active layer, Examiner respectfully disagrees. Pronovost discloses having a membrane over the active electrode area to act as a filter.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Boock et al. US 2007/0197890. Specifically FIG. 4C with the filter layer 44 on the electrode layer 43.
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 MICHAEL ANTHONY CATINA whose telephone number is (571)270-5951. The examiner can normally be reached 10-6pm.
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 on 5712723672. 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.
/MICHAEL A CATINA/Examiner, Art Unit 3791 /TSE W CHEN/Supervisory Patent Examiner, Art Unit 3791
Prosecution Insights