DETAILED CORRESPONDENCE
Summary
This is the initial Office Action based on the Postrel application filed with the Office on 3 July 2024.
Claims 1-21 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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description:
retractable plate 178 mentioned in [0091] of the published application publication;
retractable plate 279 mentioned in [0091] of the published application publication;
entry duct 75 mentioned in [0093] of the published application publication;
exit duct 77 mentioned in [0093] of the published application publication;
22b well mentioned in [0095] of the published application publication; and,
32c well mentioned in [0095] of the published application publication.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) 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.
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 16 shown in Figures 1 & 2;
Elements 54 & 55 shown in Figure 4;
Elements 2a, 2b, 56, 57 and 78 shown in Figure 6A;
Elements 29, 78, and 79 shown in Figure 6B;
Element 2b shown in Figure 6C;
Elements 2a, 78, 79 shown in Figure 6D; and,
Elements 2b and 2c shown in Figure 6E.
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 Objections
Claims 2-5 and 10-13 are objected to because of the following informalities: claim 2 recites, inter alia, “… anda consolidation component for: collecting said signal from said ouputanalyz ing …”. Appropriate correction is required. As claims 3-5 and 10-13 ultimately depend from claim 2, they are objected to for the same reasoning.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-21 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Instant independent claim 1 recites, inter alia, “… a plurality of adjustably controlled sensor elements …” However, the instant disclosure makes no mention of the phrase, “adjustably controlled sensor elements,” or variations thereof. Thus, claim 1 contains subject matter which was not described in the specification, and therefore, the claim is rejected as not meeting the written description requirements of 35 USC 112(a). All other pending claims ultimately depend from instant claim 1, and are rejected for the same reasoning.
Instant claim 21 recites a method, wherein is claimed the collection of first and second samples are “longitudinally distinct”. The instant disclosure does not recite longitudinally distinct collection of sample. Thus, claim 21 fails to meet the written description requirement set forth in 35 USC 112(a), and is therefore rejected.
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 1-21 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. It is unclear what is meant by the phrase, “adjustably controlled sensor elements”, which is recited in instant independent claim 1. What is meant to have the sensor elements controlled in an adjustable manner? What parameter of the sensor elements is adjusted, and what is the means of controlling said adjustment? Thus, the limitation is considered indefinite for failing to particularly point out and distinctly claim the subject matter; therefore, claim 1 is rejected under 35 USC 112(b). All other pending claims ultimately depend from instant claim 1, and are rejected for the same reasoning.
Claim 16 recites the limitation "the solvent". There is insufficient antecedent basis for this limitation in the claim.
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, 14 and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by a published paper by M. Cole, et al. (“Combined electronic nose and tongue for flavour sensing system”, Sensors and Actuators B: Chemical, 156(2): p. 832-839, August 2011; hereinafter, “Cole”).
Regarding claim 1, Cole discloses an analytical device (Abstract: “… a novel, smart sensing system…”) featuring:
an array of sensor elements (SEs) (Abstract: “… shear horizontal surface acoustic wave (SH-SAW) sensors … and … chemFET sensors …”)
wherein said array comprises a plurality of adjustably controlled sensor elements whose sensitivities and/or specificities are differentiated (1st ¶, 2.1. Electronic nose chemical sensors, p. 833: “ … devices were fabricated with three open gates for sensing and one closed (covered) for reference … Three different polymers were used in this study poly(ethylene-co-vinyl acetate), poly(styrene-co-butadiene) and poly(9-vinylcarbazole), mixed at an 80:20 ratio (by weight) with carbon black.”; IDTs shown in Figure 3 for SH-SAW taste sensor; 1st ¶, 2.2. Electronic tongue device, p. 834: “The configuration used is one which allows for simultaneous measurements of both mechanical (elasto-acoustic) properties, and electrical (electroacoustic) parameters of the liquid under test. This is achieved through a dual delay line configuration, one shorted (metalized and electrically shielded) and the other left free (electrically active).”) and
addressed based on the physical position of each sensor in the array (see interface and PCB shown in Figure 4a),
wherein, during analysis, a first set of said sensor elements is disposed for contact with molecules in a liquid (SAW Sensor, Figure 4b) and
a second set of said sensor elements is disposed for contact with molecules in a gas (ChemFET Sensor, Figure 4b).
Regarding claim 14, Cole teaches the ChemFETs attached to 14 pin socket, which is separable from the frame (Figures 4a & b).
Regarding claim 15, Cole teaches the first set of said sensor elements and said second set of said sensor elements reside in separate units (see ChemFET Sensor & SAW Sensor, Figure 4b).
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.
Claims 2-10 and 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Cole in view of a published paper by M.R. Cavallari, et al. (“A Hybrid Electronic Nose and Tongue for the Detection of Ketones: Improved Sensor Orthogonality Using Graphene Oxide-Based Detectors”, IEEE Sensor Journal, 17(7): p. 1971-1980 + Supplemental, April 2017; hereinafter, “Cavallari”).
Regarding claim 2, Cole teaches wherein said device has components for interfacing with an analytical unit (PTFE Frame, Figure 4b),
said analytical device further comprising at least one opening for introducing a sample to be assayed (opening inferred, as liquid under test is housed in PTFE Frame, Figure 4b);
at least one of said at least one opening having a gas path access to said second set of said sensor elements (headspace above liquid under test, Figure 4b);
at least one of said at least one opening having a liquid path access to said first set of said sensor elements (space containing liquid under test, Figure 4b);
each of said sets of sensor elements comprising a nano-sensor element (NSE) layer between an input and an output (Nano-sensor element layers: polymer coatings of ChemFET gates, 1st ¶, 2.1. Electronic nose chemical sensors, p. 833; LiTaO3 wafer substrate, 1st ¶, 2.2. Electronic tongue device, p. 834; inputs: source & drain terminal of ChemFET, Figure 1 & input IDTs of SH-SAW sensor, Figure 3; outputs: polymer-metal gate of ChemFET, Figure 1 & output IDTs of SH-SAW sensor, Figure 3)
each said input of said sets in contact with a base power source providing a feeder voltage (voltage sources for ChemFET & SH-SAW inherent for utilization);
each said output of said sets in communication with at least one data collector (inherent for data gathered, Figures 7a & 7b);
said NSE layer associated with a selection component with selection specificity for one or more compounds of interest (VGDS results of ChemFET sensors, Figure 10);
said selection component when in contact with or in close proximity to a target compound present in said vapor phase selectively altering signal to said output (VGDS results of ChemFET sensors, Figure 10); and
a consolidation component (1st ¶, 3. Measurement setup, p. 835: “chemFET sensor array was controlled using an instrument that consists of custom interface electronics, a National Instruments card and a software control system written in LabVIEWTM.”) for:
collecting said signal from said output analyzing said output to produce a profile (e.g., Figure 7b).
Cole does not teach comparing said profile to a database of signatures of diseases.
However, Cavallari disclose a hybrid electronic nose and tongue, wherein is taught identification and quantification of disease biomarkers present in fluids originating from a patient’s body (1st ¶, I. Introduction, p. 1971), and multisensorial systems such as the electronic tongue (ET) and nose (EN) are promising devices for performing such diagnoses in a noninvasive way (2nd ¶, I. Introduction, p. 1971).
At the time of the filing of the instant application, it would have been obvious to one of ordinary skill in the art to have adapted the smart sensing system taught by Cole to perform analysis to identify and quantify disease biomarkers in samples, as suggested by the disclosure of Cavallari, as this would provide a detection system for discovery of disease states in a patient.
Regarding claims 3-5, Cavallari teaches results representing a first step towards the application of impedimetric chemoresistive sensor arrays from graphene oxide composites as a non-invasive, portable, and potentially low cost instrumentation for the diagnosis of diabetes (IV. Conclusion). It would be obvious to one of ordinary skill to build a database, given the teachings of Cavallari, for reference to make determinations of positive or negative diagnosis of diabetes.
Regarding claims 6 and 10, Cole does not teach sensor elements comprising a decorated graphene sensing surface.
However, Cavallari teaches sensor arrays of electronic tongue and electronic nose comprising graphene oxide composites (A. Sensor Preparation, p. 1972; Table I).
At the time of the filing of the present application, it would have been obvious to have adapted the graphene oxide based sensor into the electronic tongue and electronic nose, taught by Cavallari, into the sensing system disclosed by Cole because it would yield a system usable for determination of biomarkers usable for diagnosis of diabetes.
Regarding claims 7 and 8, Cavallari does not explicitly teach graphene crumpled or curved.
However, it has been held a configuration of a particular claimed element was a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed element was significant.
Regarding claim 9, Cavallari teaches graphene oxide composites with β-cyclodextrin hydrate (1st ¶, A. Sensor Preparation, p. 1972).
Regarding claim 17, Cole teaches the liquid sample area is clamped down using nylon bolts (Figure 4b).
Regarding claim 18, Cole does not teach a first and second sample, collecting output and comparison to determine change in condition or disease status.
However, Cavallari suggests perform analysis to identify and quantify disease biomarkers in samples (1st ¶, I. Introduction, p. 1971). It would be obvious to one of ordinary skill that comparison of two samples would be necessary to make a determination of disease state, as a reference to positive, negative, or both results would be needed when analyzing a sample.
Regarding claim 19, Cavallari teaches samples from blood and saliva (1st ¶, B. Liquid and Gaseous Samples, p. 1972).
Regarding claim 20, from the Cavallari teachings of testing sample based on biological fluids (1st ¶, I. Introduction, p. 1971), one of ordinary skill would see it as obvious to be able to test urine via the taught sensing device, as it is a sample which is obtainable in a non-invasive manner.
Regarding claim 21, Cavallari suggest a first and second sample would be collected in a longitudinally distinct manner (1st ¶, I. Introduction, p. 1971).
Claims 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Cole in view of Cavallari as applied to claims 2 and 10 above, and further in view of a US Patent Application Publication to Johnson, et al. (US 2008/0274912 A1; hereinafter, “Johnson”).
Regarding claims 11-13, Cole in combination with Cavallari teach the limitations of instant claims 2 and 10, as outlined above.
Cole nor Cavallari teach single walled carbon nanotubes (SWCT).
However, Johnson discloses utilization of ssDNA oligonucleotide bound single wall carbon nanotube as the basis for electronic nose and electronic tongue sensing platforms ([0046]).
At the time of the filing of the present application, it would have been obvious to utilize SWCT as the sensor basis for electronic tongue and electronic nose devices taught by Cole and Cavallari as SWCT-sensors have distinct odor response characteristics (Johnson, [0046]).
Instant claim 16 is not rejected under any prior art rejection, however, it is rejected under 35 USC 112, as outlined above.
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