DETAILED CORRESPONDENCE
Summary
This is the initial Office Action based on the Karajic, et al. application filed with the Office on 26 February 2024.
Claims 1-12 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 .
Priority
The instant application is the US National Stage Application of an International Patent Application, PCT/US2022/044504, filed on 23 September 2022, which claims priority to a US Provisional Patent Application, 63/248,016, filed on 24 September 2021. Thus, 24 September 2021, is the effective filing date of the present application.
Information Disclosure Statement
The information disclosure statement (IDS) submitted regarding the present application filed on 26 February 2024, is in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS has been considered by the Examiner.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: element 190, shown in Figures 1A & 1B. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 7-9 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.
Independent claim 7 recites the limitations, “… wherein the plurality of molecules attached at the electrode surface may be either chemically or physiosorbed, and of a total of the plurality molecules attached at the electrode surface at least greater than one of 60%, 90%, 95% are chemically attached.” (Emphasis added) While the second recited limitation details a condition of chemically attached plurality of molecules at the electrode surface, this does not effective if the plurality of molecules are physiosorbed. Therefore, it is not clear as to whether the second limitation is a positively recited limitation, since a condition is possible where said limitation has no meaning (i.e., the plurality of molecules are physiosorbed at the electrode surface). Thus, claim 7 is rejected as being indefinite for failing to particularly point out and distinctly claim the subject matter. As claims 8 and 9 depend from claim 7, they are rejected for the same reasoning.
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 1-4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by a US Patent Application Publication to Xiao, et al. (US 2019/0376987 A1; hereinafter, “Xiao”).
Regarding claim 1, Xiao discloses a method of fabricating an electrochemical aptamer sensor (“Fabrication of an Electrochemical Aptamer-Based (E-AB) Sensor for Cocaine Detection”, heading between [0235] & [0236]) comprising:
incubating an electrode in the presence of components that are adapted to constitute at least a portion of a sensing monolayer, wherein the sensing monolayer includes at least a plurality of aptamers and at least one weakly bonded constituent (“The clean gold electrode was incubated with a 25 nM solution of 5' thiolated, 3' methylene blue-modified 35-GT1 containing 2 mM tris-(2 -carboxyethyl) phosphine hydrochloride in phosphate-buffered saline (PBS) (10 mM phosphate, 1 µM NaCl , and 1 mM MgCl2, pH 7.2) for 12 hours.”, [0236]);
removing the at least one weakly bonded constituent from the sensing monolayer … by incubating the electrode then applying at least one perturbation mechanism to the sensing monolayer (“The surface was then rinsed with deionized water …”, [0236]) then incubating the electrode again (“… and passivated with 3 mM 6-mercaptohexanol in the same PBS buffer for 2 hours.”, [0236]).
Regarding claim 2, Xiao discloses the perturbation mechanism is a mechanical mechanism (“The surface was then rinsed with deionized water …”, [0236]).
Regarding claims 3 and 4, Xiao discloses the sensing monolayer further comprises a blocking layer of alkythiolate (“… and passivated with 3 mM 6-mercaptohexanol in the same PBS buffer for 2 hours.”, [0236])
Allowable Subject Matter
Claims 10-12 are allowed.
Claims 5 and 6 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including 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 cited Xiao reference is considered the closest prior art reference to the instantly indicated claims. However, Xiao does not anticipate nor render obvious: i) applying the perturbation mechanism decrease a normalized current measured as a peak signal from the redox tag versus a background current decrease over 24 hours by an amount selected from the group consisting of less than 3%, less than 5%, less than 10%, less than 20%, and less than 40%, as required by instant claim 5; ii) wherein the plurality of aptamers are at least one of greater than 30%, greater than 60%, greater than 90%, or greater than 95% chemically attached to the electrode compared to a total amount of aptamers on the electrode surface via both chemical and physiosorbed attachment, as required by instant claim 6; or iii) wherein, of the plurality of molecules, at least one oof less than 40%, less than 20%, less than 10%, or less than 5% of the sensing monolayer are weakly bonded to the electrode surface, as required by instant claims 10-12.
Interview with the Examiner
If at any point during the prosecution it is believe 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 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
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 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 at (571)272-8521. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J. Christopher Ball/ Primary Examiner, Art Unit 1795
1 “35-GT” is the designation of a cocaine-binding aptamer, as shown at [0038]