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 .
Response to Amendment
The preliminary amendment filed on April 26, 2024 is acknowledged. The application will be examined accordingly.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on July 2, 2024, February 28, 2025 and November 6, 2025 are being considered by the examiner.
Claim Objections
Claims 6 and 16 are objected to because of the following informalities:
In claim 6, the limitation “the at least one sensing region(s)” should be changed to “the at least one sensing region”.
In claim 16, the limitation “lateral flow test” should be changed to “lateral flow test element”.
Appropriate corrections are required.
Claim Rejections - 35 USC § 112
In the event the determination of the status of the application as subject to AIA (or as subject to pre-AIA ) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the rationale supporting the rejection would be the same under either status.
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.
Claims 31 and 33 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 31 recites the limitation “is used”. It is unclear whether the limitation intends to convey intended use of the claimed invention, or whether the claim intends to convey that the device further comprises the label. Given that the claim does not specify a physical nexus between the claimed device and the label, it will be presumed that the label is not part of the claimed device (e.g. a sample containing the at least one analyte is labeled before it is introduced into the device). Alternatively, it will be presumed that the label is associated with the lateral flow test element, which is not part of the claimed device.
Claim 33 recites “the solution”. There is no antecedent basis for the limitation.
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.
Claims 1, 3-6, 8, 12, 14, 16, 18, 19, 23 and 31-33 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nguyen et al. (“Nguyen”) (US 2021/0007646 A1).
With respect to claim 1, Nguyen discloses a testing device 14 for evaluation of at least one analyte, the device 14 comprising (see Fig. 3):
a planar element 22;
at least one electronic sensor 30 disposed on the planar element for sensing at least one sensing region 34 of a lateral flow test element 24 for evaluation of the at least one analyte (see Fig. 4); and
an adhesive substrate (double-sided tape, see [0040]) connected to a surface of the planar element and set to connect to a surface of the lateral flow test element 24.
With respect to claim 3, as discussed above, the adhesive substrate is a double-sided tape. Naturally, it comprises a first (bottom) and second (top) adhesive opposing surfaces, the first adhesive surface connected to the surface of the planar element 22, the second adhesive surface set to connect to the surface of the lateral flow test element 24.
With respect to claim 4, as discussed above, the adhesive substrate is a double-sided tape.
With respect to claim 5, the device further comprises the lateral flow test element 24 (see Fig. 3).
With respect to claim 6, the adhesive substrate places the at least one sensing region 34 proximate to the at least one electronic sensor 30 (see Figs. 3-4 and [0041]).
With respect to claim 8, the adhesive substrate is sandwiched between the surface of the planar element 22 and the surface of the lateral flow test element 24 (see Fig. 3 and [0040]).
With respect to claim 12, the patentability of the claim is based on the structure of the device in its final form. Consequently, limitations directed to an intermediate product that no longer exists in the final product do not further limit the claimed invention. That said, the subject matter of claim 12 is directed to a feature (backing card) that is not present in the final form of the claimed device. Hence, Nguyen need not teach the backing card to anticipate the claim. Because the planar element 22 provides physical support for the lateral flow test element 24, the claim is deemed to be anticipated by the disclosure of Nguyen.
With respect to claim 14, the surface of the planar element 22 has a size of at least the size of the surface of the lateral flow test element 24 (see Fig. 3).
With respect to claim 16, the device further comprises at least one second electronic sensor (another electrode 30) disposed on the planar element 22. The lateral flow test element is not a part of the claimed invention, as evidenced by the language of claim 5. Consequently, Nguyen need not teach the limitations directed to the lateral flow test element to anticipate the claim.
With respect to claim 18, the at least one electronic sensor comprises a test electronic sensor located on the planar element for sensing a testing region, and a reference electronic sensor located on the planar element for sensing a reference region (see Figs. 3-4 illustrating parallel electrodes 30). As discussed above, the lateral flow test element is not part of the claimed invention. Consequently, limitations that solely further limit the lateral flow test element need not be taught by Nguyen to anticipate the claim.
With respect to claim 19, as discussed above, the lateral flow test element is not part of the claimed invention. Consequently, limitations that solely further limit the lateral flow test element, which is the case with claim 19, need not be taught by Nguyen to anticipate the claim.
With respect to claim 23, because the at least one electronic sensor is an electrode, it is designed to generate electromagnetic fields that follow field lines that originate from the at least one electronic sensor, pass through the adhesive substrate, pass through the at least one sensing region, pass back through the adhesive substrate, and back to the at least one electronic sensor (an electric current generates electromagnetic fields that encircle the direction of the current).
With respect to claim 31, as discussed above, the label is not deemed to be a part of the device, and hence the subject matter of the claim is deemed to be directed to recitation of intended use. In this case, the device taught by Nguyen can be used with the claimed label to extract the at least one analyte before the at least one analyte is applied to the device.
With respect to claim 32, the device further comprises a transceiver (“internal electronics of the analyzer 12”, see [0040]) configured to transmit signals sensed by the at least one electronic sensor 30 to an external computing device 12 (see Fig. 1) for analysis of the signals for measuring presence of the at least one analyte.
With respect to claim 33, the device is implemented as a single-use device designed to be disposed of after a liquid sample is applied to the lateral flow test element (see [0012]). Regarding the rest of the limitations, they are directed to the lateral flow test element, which is not a part of the claimed device. Nevertheless, the liquid sample flows through the lateral flow test element by capillary action (see [0043] disclosing that “thin” channel 34b allows fluid to flow) and reaches a wick 38.
Claims 1, 3-6, 8, 10, 12, 14-16, 18, 19, 23 and 31-33 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bryan (US 2013/0026037 A1).
With respect to claim 1, Bryan discloses a testing device for evaluation of at least one analyte, the device comprising (see Fig. 2):
a planar element 2;
at least one electronic sensor 130 disposed on the planar element 2 for sensing at least one sensing region 20 of a lateral flow test element 4 for evaluation of the at least one analyte (see [0140] and Fig. 6); and
an adhesive substrate 3 connected to a surface of the planar element 2 and set to connect to a surface of the lateral flow test element 4 (see Fig. 2).
With respect to claim 3, the adhesive substrate is a double-sided tape 3 (see [0111]). Naturally, it comprises a first (bottom) and second (top) adhesive opposing surfaces, the first adhesive surface connected to the surface of the planar element 2, the second adhesive surface set to connect to the surface of the lateral flow test element 4.
With respect to claim 4, as discussed above, the adhesive substrate is a double-sided tape.
With respect to claim 5, the device further comprises the lateral flow test element 4 (see Fig. 2).
With respect to claim 6, the adhesive substrate places the at least one sensing region 20 proximate to the at least one electronic sensor 130 (see Fig. 6 and [0140]).
With respect to claim 8, the adhesive substrate is sandwiched between the surface of the planar element 2 and the surface of the lateral flow test element 4 (see Fig. 2).
With respect to claim 10, the adhesive substrate 3 is disposed at least over the at least one electronic sensor (see Figs. 2, 5 and 6). As discussed above, the lateral flow test element is not a part of the claimed invention. Consequently, Bryan need not teach the limitations directed to the lateral flow test element to anticipate the claim.
With respect to claim 12, the patentability of the claim is based on the structure of the device in its final form. Consequently, limitations directed to an intermediate product that no longer exists in the final product do not further limit the claimed invention. That said, the subject matter of claim 12 is directed to a feature (backing card) that is not present in the final form of the claimed device. Hence, Bryan need not teach the backing card to anticipate the claim. Because the planar element 2 provides physical support for the lateral flow test element 4, the claim is deemed to be anticipated by the disclosure of Bryan.
With respect to claim 14, the surface of the planar element 2 has a size of at least the size of the surface of the lateral flow test element 4 (see Fig. 2).
With respect to claim 15, the planar element 2 comprises a printed circuit board (PCB) (see [0140]), wherein the at least one electronic sensor is integrated within the PCB (see [0140 and Fig. 6).
With respect to claim 16, the device further comprises at least one second electronic sensor (see [0140] disclosing that each well 122 comprises its own electrode 134) disposed on the planar element 2. As discussed above, the lateral flow test element is not a part of the claimed invention. Consequently, Bryan need not teach the limitations directed to the lateral flow test element to anticipate the claim.
With respect to claim 18, the at least one electronic sensor comprises a test electronic sensor 134 located on the planar element for sensing a testing region, and a reference electronic sensor 134 located on the planar element for sensing a reference region (see Fig. 6 and [0140]). As discussed above, the lateral flow test element is not part of the claimed invention. Consequently, limitations that solely further limit the lateral flow test element need not be taught by Bryan to anticipate the claim.
With respect to claim 19, the lateral flow test element is not part of the claimed invention. Consequently, limitations that solely further limit the lateral flow test element, which is the case with claim 19, need not be taught by Bryan to anticipate the claim.
With respect to claim 23, because the at least one electronic sensor is an electrode, it is designed to generate electromagnetic fields that follow field lines that originate from the at least one electronic sensor, pass through the adhesive substrate, pass through the at least one sensing region, pass back through the adhesive substrate, and back to the at least one electronic sensor (an electric current generates electromagnetic fields that encircle the direction of the current).
With respect to claim 32, the device further comprises a transceiver (“electrical terminals”, see [0139]) configured to transmit signals sensed by the at least one electronic sensor 130 to an external computing device 200 (see Fig. 4) for analysis of the signals for measuring presence of the at least one analyte.
With respect to claim 31, as discussed above, the label is not deemed to be a part of the device, and hence the subject matter of the claim is deemed to be directed to recitation of intended use. In this case, the device taught by Bryan can be used with the claimed label to extract the at least one analyte before the at least one analyte is applied to the device.
With respect to claim 33, the testing device is implemented as a single-use device (test strip) designed to be disposed of after a liquid sample is applied to the lateral flow test element. Regarding the rest of the limitations, they are directed to the lateral flow test element, which is not a part of the claimed device. Nevertheless, the liquid sample flows through the lateral flow test element 4 by capillary action (see [0110] disclosing that chamber 26 functions as a wick that draws liquid therein).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Bryan in view of Yoo (US 2009/0221431 A1).
With respect to claim 24, while Bryan discloses the use of electrodes for sensing, Bryan does not disclose capacitive sensing. Nevertheless, it would have been obvious to one of ordinary skill in the art before the effective filing date to have employed any other conventional electrical-based sensing, for example capacitive sensing, as taught by Yoo (see [0074]). According to Yoo, capacitive sensors can measure many of the same analytes (e.g. glucose) measured by the device of Bryan (see [0064]). The modification constitutes substituting one element for an equivalent for the same purpose, which is considered obvious.
Claims 26-30 are rejected under 35 U.S.C. 103 as being unpatentable over Bryan in view of Kiely et al. (“Kiely”) (WO 2005/111614 A1).
With respect to claim 26, while Bryan discloses the use of electrodes for sensing, Bryan does not disclose inductive sensing. Nevertheless, it would have been obvious to one of ordinary skill in the art before the effective filing date to have employed any other conventional electrical-based sensing, for example inductive sensing, as taught by Kiely (see p. 5 disclosing a test strip comprising an inductive sensor for detecting drugs). The modification constitutes substituting one element for an equivalent for the same purpose, which is considered obvious.
With respect to claims 27 and 28, each inductive sensor would comprise at least one planar coil with at least one layer, and a circuitry configured to activate the at least one inductive sensor at its resonant frequency (see abstract of Kiely).
With respect to claim 29, the circuitry would further comprise a controller operating at a sampling frequency and configured to measure changes in the resonant frequency of the at least one inductive sensor (see abstract of Kiely).
With respect to claim 30, the resonant frequency of the at least one inductive sensor would fall in a range of 0.001–40 MHz (see Fig. 12 of Kiely).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAUL S HYUN whose telephone number is (571)272-8559. The examiner can normally be reached M-F 8:30-5:00.
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, Luan Van can be reached at 571-272-8521. 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.
/PAUL S HYUN/Primary Examiner, Art Unit 1796
Prosecution Insights