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 Amendment filed 04/10/2026 has been entered. Claims 19-25 are pending in the application and being examined herein.
Status of Objections and Rejections
The rejection of claim 19 and 20 under U.S.C. 102 are being withdrawn in view of Applicant’s amendment.
New grounds for rejection under 35 U.S.C. 103 are necessitated by Applicant’s amendments.
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.
Claims 19-23 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Black et al. (US 20200191699 A1) in view of Gao et al. (“A single-electrode electrochemical system for multiplex electrochemiluminescence analysis based on a resistance induced potential difference.” Chem. Sci.,2018,9,3911).
Regarding claim 19, Black teaches a biosensor apparatus comprising:
a photodiode array (detection device 44)(para. 0144 and Fig. 7, detection device 44 is a CMOS made of an array of photodiodes 50), a substrate (14) atop the photodiode array (Fig. 7), an electrically conductive coating (electrode 16) atop the substrate (Fig. 7), an analyte receiving area (one of the depressions 20) atop the electrically conductive coating, the photodiode array having a field of view encompassing the analyte receiving area (para. 0146) and extending across the substrate and the electrically conductive coating (Fig. 7, paras. 0005 and 0150).
Black teaches an electrochemiluminescence (ECL) based biosensor apparatus (Fig. 7, para. 0007). Black teaches apparatus comprises an electrode 16 made of indium oxide (ITO)(para. 0052), and a patterned material 18 positioned on electrode 16 forming wells/depression 20 (Figs. 1B and 7) for multiplexed reactions (para. 0063).
Black teaches a potential is applied to electrode 16 (electrically conductive coating) to drive the ECL reaction (para. 0127), but does not explicitly teach the biosensor apparatus comprises two conductive connectors electrically connected to the electrically conductive coating at two opposite locations thereof, the electrically conductive coating having a resistance creating an electric potential gradient along the analyte receiving area when an electric potential is applied between the two opposite locations of the electrically conductive coating via the two conductive connectors.
However, Gao teaches an electrochemiluminescence (ECL) based single-electrode electrochemical system (abstract). Black teaches apparatus comprises an ITO electrode (Fig. 1A and 3), and a patterned PET material with nine circular holes is positioned on ITO forming nine cells (Figs. 3) for multiplexed reactions (p. 3913, right col.). Gao further teaches the system comprises two conductive connectors (copper wires) electrically connected to the electrically conductive coating (ITO electrode) at two opposite locations thereof (Figs. 1A and 3), the electrically conductive coating having a resistance creating an electric potential gradient along the analyte receiving area when an electric potential is applied between the two opposite locations of the electrically conductive coating via the two conductive connectors (Fig. 1A and p. 3912, right col. 1st para.). Gao further teaches the ITO electrode has a resistance of 100 ohm per square (p. 3913, left col., 2nd para.). Gao teaches the system uses only one electrode for multiplex experiments based a resistance induced potential difference, and consequently leads to the benefit of having a low-cost and simple electrochemical system (abstract).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the biosensor apparatus taught by Black to include two conductive connectors electrically connected to the electrically conductive coating at two opposite locations thereof, the electrically conductive coating having a resistance creating an electric potential gradient along the analyte receiving area when an electric potential is applied between the two opposite locations of the electrically conductive coating via the two conductive connectors as taught by Gao (abstract and p. 3913, left col., 2nd para. and Fig. 1 A), and to have modified the electrically conductive coating (ITO electrode 16) taught by Black with a thickness of 100 ohm per square resistance as taught by Gao (p. 3913, left col., 2nd para) because such modifications allow for the biosensor apparatus to employ only a single electrode for multiplex ECL analysis based on a resistance induced potential difference, and consequently, leads to the benefit of have a low-cost and simple electrochemical system (abstract and p. 3911, right col., last para.) with a reasonable expectation of success (MPEP 2143)(I)(G).
Regarding claim 20, modified Black teaches all of the elements of the current invention as stated above with respect to claim 19. Modified Black further teaches wherein when the electrical potential is applied across the electrically conductive coating, analytes present at the analyte receiving area emit electrochemiluminescence (ECL) light emission across the electrically conductive coating, across the substrate and towards the photodiode array (interpreted as an intended use. The instant invention does not recite a structure for applying an electrical volage, and analytes is not positively recited. For compact prosecution, Black, paras. 0134 and 0150 teaches an electrical potential is applied to initiate a redox reaction on an ECL label, causing the ECL-label to emit light, which is detected by photodiode 50; and Gao, Fig. 3).
Regarding claim 21, modified Black teaches all of the elements of the current invention as stated above with respect to claim 19. Black further wherein the photodiode array (detection device 44) is a lens-less photodiode array (paras. 0147-0149, detection device 44 is a CMOS, made of photodiodes 50 that are light sensors and waveguides 48 that are made of oxide surrounded by a metal material, not a lens).
Regarding claim 22, modified Black teaches all of the elements of the current invention as stated above with respect to claim 19. Black further teaches wherein the substrate (14) is placed directly on the photodiode array (44)(Fig. 7).
Regarding claim 23, modified Black teaches all of the elements of the current invention as stated above with respect to claim 19.
Black shows in Fig. 7 that the surface of substrate 14 at each depression 20 is curved, and thus fails to wherein the substrate is a flat substrate.
However, Black teaches a flowcell of a biosensor apparatus comprises substrate 14 in Fig. 1B. Black further teaches the biosensor apparatus in Fig. 7 is the flowcell in Fig. 1B integrated with a CMOS (para. 0142), and Fig. 1B teaches substrate 14 is a flat substrate (1B).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the substrate 14 shown in Fig. 7 of Black with the flat substrate 14 shown in Fig. 1B because one of ordinary skill in the art would accordingly have recognized the flat substrate would result in the predictable result of providing a substrate for the biosensing apparatus, and simple substitution of one known element (substrate of Fig. 7) for another (flat substrate of Fig. 1B) is likely to be obvious when predictable results (providing a substrate for the biosensor apparatus) are achieved (Fig. 1B). See MPEP 2143)(I)(B). Furthermore, it has been held that a mere change in shape without affecting the function of the part would have been within the level of ordinary skill in the art, In re Dailey et al. , 149 USPQ 47 (MPEP 2144.04 (IV)(B)). Black discloses in Fig. 7 the substrate but fails to teach the substrate is a flat substrate. It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the substrate 14 of Fig. 7 in Black to be a flat substrate since it has been held that a mere change in shape of an element is generally recognized as being within the level of ordinary skill in the art when the change in shape is no significant to the function of the combination. Furthermore, one would have been motivated to select the shape of substrate to be flat for the purpose of making it easier to manufacture.
Regarding claim 25, modified Black teaches all of the elements of the current invention as stated above with respect to claim 19. Modified Black further wherein the resistance of the electrically conductive coating ranges between 60 ohm/square and 100 ohm/square (Gao, p. 3913, left col., 2nd para.).
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Black et al. (US 20200191699 A1) in view of Gao et al. (“A single-electrode electrochemical system for multiplex electrochemiluminescence analysis based on a resistance induced potential difference.” Chem. Sci.,2018,9,3911) and evidenced by SPI Supplies (Non Patent Literature, “SPI Supplies® Brand Indium-Tin-Oxide (ITO) Coated Substrates- Technical Data Sheet,” Oct 21, 2019, retrieved from the internet URL http://web.archive.org/web/20191021104337/https://www.2spi.com/ito-tech-data/, [retrieved on 8/25/2026].
Regarding claim 24, modified Black teaches all of the elements of the current invention as stated above with respect to claim 19. Modified Black further wherein the electrically conductive coating has a thickness below 200 nm (ITO film with a resistance of 100 ohm per square has a thickness below 200 nm as evidenced by SPI, “Coating resistivities and thicknesses are available as standard products:”, 70-100 ohms/square has a thickness of 70 nm).
Response to Arguments
Applicant’s arguments, see p. 3, filed 04/10/2026, with respect to the rejection(s) of claims 19-20 under 35 U.S.C. 102(a)(1) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Black et al. (US 20200191699 A1) in view of Gao et al. (“A single-electrode electrochemical system for multiplex electrochemiluminescence analysis based on a resistance induced potential difference.” Chem. Sci.,2018,9,3911) .
Applicant's comments, see p. 4, filed 04/10/2026, with respect to new claims 21-22 have been fully considered but they are not persuasive. The Applicant states that Black discloses use of lenses and waveguides 48, and thus fails to teach a lens-less photodiode array.
The examiner respectfully disagrees. Black does not disclose the use of lenses, but rather teaches waveguides 48 are made of oxide surround by metal material (para. 149). Furthermore, it is unclear how the above argument is related to claim 22, which is not dependent on claim 21. Therefore, this argument is unpersuasive.
Applicant's comments, see p.4, filed 04/10/2026, with respect to new claims 23-25 have been fully considered and are persuasive. However, upon further consideration, an obviousness rejection on claim 23 is made in view of Black et al. (US 20200191699 A1), an obviousness rejection is made on claims 24 in view of Black et al. (US 20200191699 A1) in view of Gao et al. (“A single-electrode electrochemical system for multiplex electrochemiluminescence analysis based on a resistance induced potential difference.” Chem. Sci.,2018,9,3911) as evidence by SPI Supplies (Non Patent Literature, “SPI Supplies® Brand Indium-Tin-Oxide (ITO) Coated Substrates- Technical Data Sheet,” Oct 21, 2019, retrieved from the internet URL http://web.archive.org/web/20191021104337/https://www.2spi.com/ito-tech-data/, [retrieved on 8/25/2026], and an obviousness rejection is made on claim 25 in view of Black et al. (US 20200191699 A1) in view of Gao et al. (“A single-electrode electrochemical system for multiplex electrochemiluminescence analysis based on a resistance induced potential difference.” Chem. Sci.,2018,9,3911) .
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 MAY CHIU whose telephone number is (571)272-1054. The examiner can normally be reached 9 am - 5 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, Maris Kessel can be reached at 571-270-7698. 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.
/M.L.C./Examiner, Art Unit 1758
/MARIS R KESSEL/Supervisory Patent Examiner, Art Unit 1758
Prosecution Insights