DETAILED CORRESPONDENCE
Summary
This Office Correspondence is based on the Amendment filed with the Office on 21 July 2026, regarding the Koul, et al. application.
Claims 1-16 are currently pending and have been fully considered.
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 § 112
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 1-16 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.
The term “oversaturated” in each of claims 1 and 5 is a relative term which renders the claim indefinite. The term “oversaturated” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Is oversaturated with capture ligands some percentage above the amount of first capture ligands it takes to form a monolayer on the WE surface? If so, what percentage? It is not clear from the term “oversaturated” to what degree of first capture ligands coverage of the WE surface is necessary to reach this condition. Is it any amount above the cross-linked, predefined concentration of second capture ligands on the second WE? As all other pending claims ultimately depend from one of either rejected claim 1 or 5, they are rejected for the same reasoning.
Claims in View of the Prior Art
No prior art reference completely anticipates or renders obvious the instant pending claims. The closest prior art is a US Patent Application Publication to Sheppard (US 2011/0089957 A1; hereinafter, “Sheppard”). Sheppard discloses a potentiostat circuit and related circuitry used for controlling the operation of an array of biosensors or other electrochemical sensors ([0002]) usable in medical applications, wherein is taught least two working electrodes that are operative with a single control amplifier that is configured to provide a reference electrode and a counter electrode. Each of the respective working electrodes is utilized as part of a biosensor (or alternatively, a chemical/electrochemical sensor) for detecting or measuring an analyte, in vitro or in vivo ([0011]). Sheppard further teaches the sensors may be used in diagnostic test meters ([0025]). However, Sheppard fails to anticipate or render obvious at least a first working electrode that is oversaturated with one or more first capture ligands, as required by both instant independent claims 1 and 5. No other reference was found to teach this limitation.
Response to Arguments
Applicant’s arguments filed 21 July 2026, with respect to the drawings have been fully considered and are persuasive. The objection of the drawings has been withdrawn.
Applicant’s arguments, filed on 21 July 2026, regarding the interpretation of limitations under 35 USC 112(f) are noted. Interpretation under 35 USC 112(f) is just that, claim limitation interpretation; it is not an objection/rejection in and of itself.
Applicant's arguments filed 21 July 2026, with respect to the rejection of the claims under 35 USC 112(b) in view of the usage of the term, “oversaturated”, have been fully considered but they are not persuasive. While Applicant has stated that the term “oversaturated” (in bold and underlined emphasis) “it is a well-understood functional state defining a surface that has been deliberately crowded with capture ligands beyond a normal mono-layered or baseline stoichiometric saturation point”, the Examiner finds no evidence of such an understanding when viewing the patent and non-patent literature. There has been no evidence provided or pointed to that supports the meaning of the term “oversaturated” as laid forth in Applicant’s arguments. Therefore, the Examiner is unpersuaded that the term “oversaturated” is not a relative term which makes the pending claims indefinite.
Interview with the Examiner
If at any point during the prosecution it is believed an interview with the Examiner would further the prosecution of an application, please consider this option.
The Automated Interview Request form (AIR) is available to request an interview to be scheduled with the Examiner. First, an authorization for internet communications regarding the case should be filed prior or with an AIR online request.
The internet communication authorization form (SB/0439), which authorizes or withdraws authorization for internet-based communication (e.g., video conferencing, email, etc.) for the application must be signed by the applicant or the attorney/agent for applicant. The form can be found at:
https://www.uspto.gov/sites/default/files/documents/sb0439.pdf
The AIR form can be filled out online, and is automatically forwarded to the Examiner, who will call to confirm a requested time and date, or set up a mutually convenient time for the interview. The form can be found at:
https://www.uspto.gov/patent/uspto-automated-interview-request-air-form.html
The Examiner encourages, but does not require, interviews by the USPTO Microsoft Teams video conferencing. This system allows for file-sharing along with audio conferencing. Microsoft Teams can be used as an internet browser add-on in Microsoft IE, Google Chrome, or Mozilla Foxfire, or as a temporary Java-based application on these browsers. Steps for joining an Examiner setup Microsoft Teams can be found at the USPTO website:
https://www.uspto.gov/patents/laws/interview-practice#step3
Additionally, a blank email to the Examiner at the time of a telephonic interview can be used for a reply to easily allow for Microsoft Teams communication. Please note, policy guidelines regarding Internet communications are detailed at MPEP §500-502.3, and office policy regarding interviews are detailed at MPEP §713.
Conclusion
THIS ACTION IS MADE FINAL. 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 JOHN C BALL whose telephone number is (571)270-5119. The examiner can normally be reached on M - F, 9 am - 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, Luan Van can be reached on (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 an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/J. Christopher Ball/ Primary Examiner, Art Unit 1795
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