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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on April 17, 2026 has been entered.
Status of Objections and Rejections
All rejections from the previous office action are withdrawn and new objections and grounds of rejection under 35 U.S.C. 103 are presented.
Claim Objections
Claim(s) 1 is/are objected to because of the following informalities:
Claim 1, line 14: “non-specifically-bound analyte and/or non-analyte species” suggested to be “the non-specifically-bound analyte and/or non-analyte species”
Appropriate correction is required.
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.
Claim(s) 9, 11 and 16 is/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 pre-AIA the applicant regards as the invention.
Claim 9 recites the limitation "the rate of change" in line 2. There is insufficient antecedent basis for this limitation in the claim. It is suggested to be “a rate of change.”
Claim 11 recites the limitation "the rate of change" in line 2. There is insufficient antecedent basis for this limitation in the claim. It is suggested to be “a rate of change.”
Claim 16 recites the limitation "an/the electric field" in line 3. It is unclear whether this electric field configured so as to cause movement of the analyte towards the capture species is different from the electric field configured to remove the non-specifically-bound analyte and/or non-analyte species from at least a portion of the sensing element as recited in claim 1. It is suggested to be “applying a second electric field to the sample matrix on the sensing element, the second electric field being configured so as to cause movement of the analyte towards the capture species.”
Allowable Subject Matter
Claim(s) 1-2, 5-16, and 21 is/are allowable if rewritten to overcome the objection and rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: The prior art does not disclose nor render obvious all of the cumulative limitations of claims 1-2, 5-8, 10, 12-15, and 21 with particular attention to the limitations:
determining an adjustment factor based on the measurement signal during the step of removing at least the portion of the non-specifically-bound analyte and/or non-analyte species from the sensing element and after the sample baseline measurement; and adjusting at least one parameter of the step of removing at least the portion of the non- specifically-bound analyte and/or non-analyte species from the sensing element based on the adjustment factor (claim 1).
Here, Paik (US 2017/0356904) teaches a method for determining a property of an analyte in a sample (¶4), the sample comprising the analyte, non-analyte species and a sample matrix in which the analyte and non-analyte species are contained (¶17), the method comprising:
providing a sensor assembly (Fig. 5; ¶77), the sensor assembly comprising a sensing element (Fig. 5: sensing location 507 or 514) comprising a capture species (Fig. 5: antibody 505 or 519) configured to specifically bind with the analyte (¶77: a first target antigen 504 binds to the first antibody 505), the sensing element providing a measurement signal indicative of the interaction of the sensing element with the sample (¶4: detecting a signal of the target analyte on the one or more surfaces);
providing the sample to the sensing element (¶4: bringing the one or more surfaces in contact with a solution), wherein at least a portion of analyte in the sample non-specifically bind to the sensing element and wherein least a portion of analyte specifically-binds to the sensing element (Fig. 6A; ¶79);
obtaining a sample baseline measurement based on the measurement signal (Fig. 11A-B: signal plateau 1106);
removing at least a portion of the non-specifically-bound analyte from the sensing element by applying an electric field to the sample matrix (Fig. 6C), the electric field configured to remove non-specifically-bound analyte from at least a portion of the sensing element but having a strength less than that required to detach specifically-bound analyte from the sensing element (¶81); and
determining the property of the analyte in the sample based on the measurement signal after the step of removing at least a portion of the non-specifically-bound analyte from the sensing element (¶82: to determine the binding force between the target antigen and the capture probe).
Paik further discloses the applied voltage increases linearly and the measurement signal drops at 1114 (Fig. 11B; ¶96). Although the slope of the dropping signal is caused by the increasing rate of the applied voltage (see Fig. 8A, ¶84: the applied voltage increases over time at a different increasing rate at different confinement features 801, 802), Applicant convincingly indicates that Paik does not determine this slope during the removing the non-specifically-bound analyte and/or non-analyte species (see Specification, ¶34: the rate of change in the measurement signal during the removing step) which may provide an indication of the effectiveness of the process (¶34) or adjusting one parameter, e.g., the intensity or strength of the electrical field to remove species that have a stronger non-specific affinity (see ¶34). Examiner notes here that the adjustment factor is interpreted as the slope of the measurement signal, i.e., the rate of change of the measurement signal (e.g., ¶34: the rate of change may provide an indication of the effectiveness of the process, i.e., the removal step), and the parameter is interpreted as the strength of the applied electric field (e.g., claims 7, 13) that is adjustable when the slope changes (see claim 21: wherein the adjustment factor is based on a change in a rate of change in the measurement signal).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CAITLYN M SUN whose telephone number is (571)272-6788. The examiner can normally be reached on M-F: 8:30am - 5:30pm.
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 V 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 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.
/C. SUN/Primary Examiner, Art Unit 1795
Prosecution Insights