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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 27-31 in the reply filed on 07/13/26 is acknowledged.
Claims 32-52 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 07/13/2026.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 27-29 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kohlmann (WO 2019115725 A1) as cited in the previous Office Action.
Kohlmann discloses a wrapper for a diagnostic test device (Fig. 3), the wrapper (21, Fig. 3) comprising:
a flexible substrate (preparation device 1)
an electronic section (para. [0063]) on the flexible substrate comprising:
a measurement section (para. [0061]-[0062]) for measuring properties in or of a test area;
an antenna (26);
a modulator-demodulator (24) coupled to the antenna (26);
a data processing unit (25) coupled to the measurement section (para. [0061]-[0062]) and to the modulator-demodulator (24); and
an energy-harvesting unit coupled to the antenna and to the data processing unit (energy storage device, para. [0040]); wherein the data processing unit (25) is configured, upon receiving a measurement from the measurement section, to generate a message containing the measurement and/or a result of processing the measurement and to transmit the message via the modulator-demodulator (24) and the antenna (25) (para. [0061]-[0063]).
Regarding claim 28, Kohlmann discloses the claimed invention as discussed above in claim 27. Kohlmann discloses the measurement section comprises:
at least one light source (light source 22, Fig. 3; para. [0061]); and
at least one light/image sensor (photo sensor 23, Fig. 3; para. [0061]);
wherein the at least one light source and the at least one light/image sensor are arranged to measure transmission, absorbance, and/or reflectance through or by the test area (Thereby, the left-hand photo sensor 23 is arranged to receive light of the left-hand light source 22 reflected by the fluorescent marker bound to AMH at the concentration line 13. Para. [0061]).
Regarding claim 29, Kohlmann discloses the claimed invention as discussed above in claim 28. Kohlmann discloses each test area is provided with at least one pair comprising a light source and a light/image sensor (para. [0061]).
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.
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.
Claim(s) 30-31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kohlmann in view of Gershtein (US 20190054466 A1).
Regarding claim 30, Kohlmann discloses the claimed invention as discussed above in claim 27. Kohlmann does not explicitly disclose the measurement section comprises an electrochemical sensor.
In an analogous art, Gershtein discloses devices, systems, and methods for performing bioimaging (Fig. 1 and 3) comprising a light emitter (555, Fig. 5) positioned over the sample testing conduit, wherein the light emitter is provided on an image sensor (imager) for imaging the sample (In other embodiments, the light emitter 555 is provided on the imager chip or imager chip carrier within the testing device or cartridge (e.g., the testing device or cartridge 110 as discussed with respect to FIG. 1). Para. [0072]). Additionally, Gershtein the device can incorporate an electrochemical sensor for assessing the qualitative, semi-quantitative, or quantitative analysis of the analyte in the sample (para. [0160]) in addition to an optical sensor (para. [0105]).
It would have been obvious to one of ordinary skilled in the art before the effective filing date to have incorporated an electrochemical sensor as taught by Gershtein to the device of Kohlman to derive the claimed invention. Doing so provides an alternative means for analysis (The design and arrangement of sensor chips 1500/1510, first sensor 1505, second sensor 1515, wiring 1530, and/or conductive contact 1535 is preferably selected based on printing and performance characteristics (e.g., minimize interference between multiple sensors, maximize transmission of light through the conduit and biological specimen, avoidance of interfering light, size constraints, etc.). para. [0105]).
Regarding claim 31, Modified Kohlmann discloses the claimed invention as discussed above in claim 30. Gershtein, after incorporation, discloses the electrochemical sensor comprises an electrode (The second sensor 1515 may be an electrochemical sensor constructed with an array of metal disks or electrodes…para. [0105]) coated with a receptor which binds to a specific target molecule (In accordance with these aspects, the second sensor 1515 contains a capture region or regions 1550 coated with capture antibodies that are configured to bind to a target analyte bound to the antibody-enzyme conjugate. Para. [0108]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICKEY HUANG whose telephone number is (571)272-7690. The examiner can normally be reached M-F 9:30-5:30 PM ET.
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/M.H./Examiner, Art Unit 1758
/REBECCA M FRITCHMAN/Primary Examiner, Art Unit 1758
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