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 .
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because of the inclusion of legal phraseology such as “comprises”. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Drawings
The drawings are objected to because Figures 6A and 6B are not clearly labeled. It is difficult to distinguish Figure 6A from Figure 6B. In addition, Figure 12(d) is not labeled. There is no label for what should be Figure 12(d) in the drawings. 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. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. 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 1-10, 13-21 and 25 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.
On line 4 of claim 1, the phrase “a plurality of sensor analytes associated with the sensing electrode” is indefinite since it is not clear what is meant by “associated with” in this phrase. What constitutes being “associated with” the sensing electrode? Does this mean that the plurality of sensor analytes are bound to the sensing electrode, or are coated onto the sensing electrode? On lines 8-9 of claim 1, the phrase “association of a portion of the oxidized sample analyte with the sensing electrode” is indefinite since it is not clear how the portion of the oxidized sample is “associated with” the sensing electrode. Is the oxidized sample “associated with” the sensing electrode by being bound to the sensing electrode, or coated onto the sensing electrode?
On line 2 of claim 3, the phrase “the baseline electrode” lacks antecedent basis since claim 3 depends from claim 1, and claim 1 does not positively recite a baseline electrode. Rather, claim 2 recites a baseline electrode.
On line 6 of claim 13, the phrase “associating the plurality of the sensor analytes with the sensing electrode” is indefinite since it is not clear what is meant by “associating” in this phrase. What constitutes the action of “associating” with the sensing electrode? Does this mean that the plurality of sensor analytes are bound to the sensing electrode, or are coated onto the sensing electrode? On lines 10-11 of claim 13, the phrase “association of a portion of the oxidized sample analyte with the sensing electrode” is indefinite since it is not clear how the portion of the oxidized sample is “associated with” the sensing electrode. Is the oxidized sample “associated with” the sensing electrode by being bound to the sensing electrode, or coated onto the sensing electrode?
Claim 18 is indefinite since it is no clear when in the process recited in independent claim 13 that the sensing electrode is washed and/or polished. Does this step occur after contacting the sensing electrode with the plurality of sensor analytes?
On line 2 of claim 19, the phrase “to associate the plurality of the sensor analytes” is indefinite since it is not clear what is meant by “to associate” in this phrase for the same reasons as set forth above.
On lines 4-5 of claim 25, the phrase “to associate a portion of the oxidized sample analyte with a surface of the sensing electrode” is indefinite since it is not clear what is meant by “to associate” in this phrase for the same reasons as set forth above. On lines 6-7 of claim 25, the phrase “the at least one electric potential” should be changed to –the electric potential—so as to use the same terminology as recited in claim 1.
Inventorship
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.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.9-
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-10, 13-21, 23 and 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Worden et al (US 2017/0299581, submitted in the IDS filed on August 18, 2023) in view of Dweik et al (US 2020/0400695).
With regards to claims 1-5, 13 and 21, Worden et al teach of a sensor for detecting a sample analyte having an oxidizable phenolic group and a process for making the sensor, wherein the sample analyte having an oxidizable phenolic group comprises the cannabinoid delta-9-tetrahydrocannabinol (THC) (claims 4-5 and 21, see paragraphs 0048 and 0166-0168 in Worden et al). In the embodiment depicted in Figure 3A of Worden et al which uses a competitive displacement assay to determine THC in a sample, the sensor 300A comprises a sensing electrode 310 as a working electrode, a reference or baseline electrode (claim 2, see paragraph 0078 in Worden et al), a sensor interface 330 having redox cycle enzymes 334, oxidized molecules 364 and reduced molecules 368 therein, and a plurality of sensor analytes 344 associated with the sensing electrode 310. The plurality of sensor analytes 344 comprise THC conjugated to an alkaline phosphatase (ALP) enzyme 354, and therefore, the ALP-conjugated THC sensor analytes comprise a first chemical species that corresponds to the THC sample analyte having an oxidizable phenolic group. When using the sensor depicted in Figure 3A of Worden et al to detect THC in a sample using a competitive displacement assay, the ALP-conjugated THC sensor analytes are initially immobilized to a surface of the sensor 300A by being bound to anti-THC antibodies 340 which are located on the surface of the sensor. When a substrate for the alkaline phosphatase enzyme is added to the sensor and an electric potential is applied to the sensor, the ALP enzyme reacts with the substrate to form a phenolic trigger molecule 370 that triggers a reaction of a redox cycle amplification pathway in the sensor interface 330 leading to the generation of an electric current. The phenolic trigger molecule 370 diffuses into the sensor interface 330 containing the redox cycle components comprising the oxidized molecules 364, the reduced molecules 368 and the redox cycle enzymes 334. The oxidized and reduced molecules 364 and 368 can be oxidized and reduced forms of phenolic and quinone compounds. The phenolic trigger molecule 370 can be either an oxidized molecule 364 or a reduced molecule 368. The phenolic trigger molecule 370 enters the redox cycle where an enzyme 334 converts the phenolic trigger molecule 370 to a catechol as a reduced molecule 368. Catechol is then oxidized by an enzyme 334 to o-quinone as an oxidized molecule 364 which in turn is reduced by the electrode 310 to form catechol as reduced molecule 368, thus propagating a redox cycling loop between the oxidized and reduced forms of catechol. A current is generated by the electrochemical reduction of the oxidized molecule 364, and this electric current serves as an output for an amount of the ALP-conjugated THC sensor analytes initially immobilized to a surface of the sensor 300A. When a sample containing THC is added to the sensor, the THC molecules serve to displace some of the ALP-conjugated molecules on the surface of the electrode 310 in proportion to a concentration of THC in the sample. Therefore, the ALP-conjugated THC sensor analytes competing with the THC analyte in the sample for binding to the electrode 330 serve to facilitate the association of a portion of the THC analyte in the sample with the sensing electrode 330 by allowing the THC sample analyte to displace the ALP-conjugated sensor analyte bound to the anti-THC antibodies 340 on the sensor surface. In addition, the ALP-conjugated THC sensor analytes also serve to facilitate the oxidation of the oxidizable phenolic group of the THC analyte to obtain an oxidized THC analyte by allowing the THC analyte to become bound to the anti-THC antibodies 340 and enter into the same redox cycle amplification pathway in the sensor interface 330 that the sensor analytes experienced prior to being displaced by the THC sample analyte. See Figure 3A, paragraphs 0012, 0023, 0028,0034, 0048, 0096-0101, 0149-0154 and 0166-0168, and the claims in Worden et al.
Worden et al fail to teach that the sensor for detecting THC in a sample also comprises a sample receiving region in fluid communication with the sensing working electrode 310 and a substrate for receiving the sensing working electrode 310 and the baseline electrode.
Dweik et al teach of an electrochemical sensor for detecting delta-9-tetrahydrocannabinol (THC) in a sample. The sensor comprises a working electrode 41, a counter electrode 43, and a reference baseline electrode 45 disposed on a substrate 33. The substrate 33 containing the electrodes is in communication with a sample receiving region that comprises a tube assembly 111 for transmitting a saliva sample into the sensor for contacting the working electrode 41. When THC present in a saliva sample contacts the working electrode and a potential is applied to the sensor, the THC is electrochemically detected using a pulse voltammetry technique, such as square-wave voltammetry. See Figures 1 and 3(a), the abstract and paragraphs 0064-0067, 0077 and 0089-0090, and the claims in Dweik et al.
Based upon a combination of Worden et al and Dweik et al, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the electrochemical sensor for detecting a THC analyte in a sample taught by Worden et al with both a sample receiving region in fluid communication with the sensing working electrode 310 and a substrate for receiving the sensing working electrode 310 and the baseline electrode because Dweik et al teach that in electrochemical sensors for detecting THC in a sample such as saliva, it is common to mount both working and reference or baseline electrodes on a substrate and to provide a sample receiving region in fluid communication with the electrodes so as to provide a physical device that is portable, cost-effective and non-invasive.
With regards to claim 6, Worden et al teach that the sensing working electrode 310 of the sensor can comprise a carbon material. See paragraph 0076 in Worden et al.
With regards to claims 7-8, both Worden et al and Dweik et al teach of testing a saliva sample with the electrochemical sensor. See paragraph 0168 in Worden et al and the abstract in Dweik et al.
With regards to claims 9-10, Worden et al teach that the THC sample analyte is detected using one of linear sweep voltammetry or cyclic voltammetry. See paragraph 0087 in Worden et al. Dweik et al also teach of a detecting THC in a saliva sample using square wave voltammetry. See the abstract in Dweik et al.
With regards to claims 14-16, the combination of Worden et al and Dweik et al fails to teach that the plurality of ALP-conjugated THC sensor analytes are provided in a solution of an organic solvent such as methanol. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the ALP-conjugated THC sensor analytes taught by Worden et al in a solution of an organic solvent such as methanol because organic solvents such as methanol are commonly used to stabilize and store samples containing THC analyte.
With regards to claim 17, the combination of Worden et al and Dweik et al fails to teach that the plurality of ALP-conjugated THC sensor analytes are diluted prior to contacting the sensing electrode 310 with the sensor analytes. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to dilute the plurality of ALP-conjugated THC sensor analytes taught by Worden et al prior to contacting the sensing electrode 310 with the sensor analytes so as to ensure that the concentration of sensor analytes is in proportion to the number of available binding sites on the surface of the electrode 310 able to bind to the sensor analytes.
With regards to claim 18, the combination of Worden et al and Dweik et al fails to teach that the sensing electrode 310 in the sensor is washed and/or polished in the method of preparing the electrochemical sensor. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to wash and/or polish the sensing electrode 310 in the sensor taught by Worden et al during its preparation so as to remove any extraneous, interfering substances from the electrode that could contaminate and affect the proper electrochemical measurement of THC in a sample.
With regards to claim 19, Worden et al teach of applying an electrical potential to the sensing electrode 310 to associate the plurality of ALP-conjugated THC sensor analytes with the sensor electrode since when a substrate for the alkaline phosphatase enzyme (ALP) associated with the sensor analytes is added to the sensor and an electric potential is applied to the sensor, the ALP enzyme reacts with the substrate to form a phenolic trigger molecule 370 that triggers a reaction of a redox cycle amplification pathway in the sensor interface 330 leading to the generation of an electric current.
With regards to claim 20, the combination of Worden et al and Dweik et al fails to teach that the plurality of ALP-conjugated THC sensor analytes are electrodeposited on the sensing electrode 310. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to electrodeposit the plurality of ALP-conjugated THC sensor analytes onto the sensor electrode 310 taught by Worden et al because electrodeposition would avoid altering the electrochemical properties of the sensing electrode 310.
With regards to claim 23, Worden et al teach of determining an electric current component resulting from the ALP-conjugated THC sensor analytes associated with the sensing electrode in the presence of an electric potential since when a substrate for the alkaline phosphatase enzyme (ALP) is added to the sensor and an electric potential is applied to the sensor, the ALP enzyme reacts with the substrate to form a phenolic trigger molecule 370 that triggers a reaction of a redox cycle amplification pathway in the sensor interface 330 leading to the generation of an electric current. See paragraphs 0166-0167 in Worden et al.
With regards to claim 25, the combination of Worden et al and Dweik et al teaches of a method for detecting a THC sample analyte in a saliva sample, wherein the THC contains an oxidizable phenolic group, comprising the steps of receiving a saliva sample on the sensor, applying an electric potential to the sensing electrode 310 to oxidize the THC analyte and to associate a portion of the oxidized THC with a surface of the sensing electrode, and obtaining a measured current from the sensing electrode while the electric potential is applied. In the competitive displacement assay taught by Worden et al, a sample containing THC is added to the sensor and the THC molecules serve to displace some of the ALP-conjugated THC sensor analytes on the surface of the electrode 310 in proportion to a concentration of THC in the sample. When an electric potential is then applied to the sensing electrode 310 of the sensor, the oxidizable phenolic group of the THC analyte becomes oxidized. The oxidized THC acts as a trigger molecule 370 that enters into the same redox cycle amplification pathway in the sensor interface 330 of the electrode 310 that the sensor analytes experienced prior to being displaced by the THC sample analyte. The redox cycle amplification pathway produces a current representative of the amount of THC in the sample. Worden et al fails to teach that the method further comprises comparing the measured current to a baseline current to determine a difference, wherein the baseline current represents a current resulting from interfering electroactive agents in the sample, and detecting a presence of the THC in the sample when the difference exceeds a detection threshold. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to perform these additional steps in the method taught by the combination of Worden et al and Dweik et al because doing so would eliminate any portion of the measured sample current that is due to interfering electroactive agents in the sample, thus resulting in a more accurate measurement of the sample analyte.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Please make note of: Kampouris et al (WO 2009/0130471) who teach of an electrochemical assay for a phenol analyte: Chaum et al (US 11,686,722) who teach of a method to detect molecules such as THC in a sample using a voltametric sensor; Compton et al (US 2013/0098779) who teach of a method for the detection of phenol compounds using an electrochemical sensor; Nissim et al (article from Chemistry Central Journal, vol. 9:41, pages 1-7, 2015) who teach of an absorptive stripping voltammetry method for cannabis detection; and Ortega et al (article from Talanta, vol. 236, 122863, pages 1-10, September 9, 2021) who teach of an electrochemical method and sensor for detecting THC in saliva by turning a sample analyte into a sensor analyte, which is substantially the same method and sensor as recited in the instant claims; however, Ortega et al is not prior art against the instant claims since it was published after the effective filing date of the instant application, which is February 19, 2021.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAUREEN M WALLENHORST whose telephone number is (571)272-1266. The examiner can normally be reached on Monday-Thursday from 6:30 AM to 4:30 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lyle Alexander, can be reached at telephone number 571-272-1254. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MAUREEN WALLENHORST/Primary Examiner, Art Unit 1797 February 4, 2026