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 .
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 - 14, 16, 17, and 19 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.
In regard to claim 1, lines 3 – 5 recite, “wherein the system is configured to: take measurements… and compare data…” However, it is unclear what positively claimed elements are carrying out the steps of taking measurements and comparing data. Claims 2 – 14 are rejected by virtue of dependence on claim 1.
In regard to claim 2, lines 1 – 3 recite, “the system is configured to compare a data pattern of a first time with a data pattern of the second time and determine a time window of cannabinoid use based on the comparison.” However, it is unclear if the limitations of claim 2 require that a second time window be determined in addition to the time window determined in claim 1 or if the time window of claim 1 is the same time window of claim 2, in which case Examiner recommends amending “a time window” to -- the time window -- in line 2.
In regard to claim 9, line 1 recites, “the compound is in the form of a self-assembling monolayer.” However, “the form” lacks antecedent basis. Examiner recommends amending claim 9 to -- the compound is a self-assembling monolayer --.
In regard to claim 16, line 2 recites “the graphene sensor elements.” However, “the graphene sensor elements” lack antecedent basis.
In regard to claim 17, lines 2 - 3 recite “the graphene sensor elements.” However, “the graphene sensor elements” lack antecedent basis.
In regard to claim 19, lines 1 – 2 recite, “taking breath samples of a test subject at a first time and at a second time”. However, it is unclear if these are the same “first time” and “second time” periods specified in claim 15, in which case Examiner recommends amending claim 19 to -- taking breath samples of a test subject at [[a]] the first time and at [[a]] the second time --, or if claim 19 requires additional testing periods.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1 - 20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The independent claims recite details of a system and method for detecting cannabinoids in breath comprising a sensor device and measurement circuit, which are all within a statutory category of invention, to “compare data of the first time with data of the second time and determine a time window of cannabinoid use based on the comparison” which falls into the category of a mental process. This judicial exception is not integrated into a practical application because with regard to Revised step 2A, prong 1, an exception is present as noted above and with regard to Revised step 2A, prong 2, the claim does not recite additional elements that integrate the judicial exception into a practical application. Further, with regard to Revised step 2B, the claim does not recite additional elements that integrate the judicial exception into practical application. In particular, claim 1 includes the limitations of “a sensor device” and “a measurement circuit” wherein the system is additionally configured to “take measurements at a first time and at a second time”, which is not sufficient to integrate the judicial exception into practical application because the “sensor device” and “measurement circuit” are merely nominal or high level structures that do not provide specific structural details beyond those well known in the art and thus provide no meaningful limitations or specific structure to integrate the judicial exception into practical application. Similarly, claim 15 includes the limitation of “taking measurements using a graphene sensor…” where the “graphene sensor” is a nominal or high-level structure that do not provide specific structural details beyond those well known in the art and thus provide no meaningful limitations or specific structure to integrate the judicial exception into practical application. Claims 2, 10, 11, 12, 13, 14, and 18 are directed towards data collection and processing steps and are not sufficient to integrate the judicial exception into practical application. Claims 3, 4, 16, and 17 are directed towards providing a voltage stimulus to the sensor via the measurement circuit, but do not provide further structural details about the measurement circuit or sensor that are sufficient to integrate the judicial exception into practical application. Claims 5 – 9 and 20 are directed towards the sensor device comprising “graphene sensor elements”, but “graphene sensor elements” comprise nominal or high level structures that do not provide specific structural details beyond those well known in the art and thus provide no meaningful limitations or specific structure to integrate the judicial exception into practical application and the further details about the graphene sensor elements do not tie in to or align with the overall function of the device or the actual detection of the cannabinoids such that the details are not sufficient to integrate the judicial exception into practical application. Claim 19 is further directed towards the collection of a breath sample but does not provide further details about specific structural details beyond those well known in the art and thus provides no meaningful limitations or specific structure to integrate the judicial exception into practical application.
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.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 2, 5, 7, 10, 11, 12, 13, 14, 15, 18 & 19 are rejected under 35 U.S.C. 103 as being unpatentable over Star (US 20230309920 A1 – Cited By Applicant) in view of DeGregorio (DeGregorio M., et al. A comprehensive breath test that confirms recent use of inhaled cannabis within the impairment window. Sci Rep. 2021;11(1):22776. Published 2021 – Cited by Applicant) and Degregorio ‘649 (WO 2019209649 A1).
In regard to claims 1 and 15, Star discloses a system for detecting cannabinoids in breath (paragraph [0004]; FIGs. 3D & 3E) comprising a sensor device (FIGs. 1A & 1B, component 10) and a measurement circuit in connection with one or more sensors, where the sensors comprise graphene nanostructures (paragraph [0007]; FIG. 10A) used to measure an electrical or optical variable based upon the presence of THC to determine a metric such as THC concentration (paragraph [0004]). Star additionally discloses determining a concentration of THC by checking the difference between a measured calibration value of a sensor taken at a first time (paragraph [0088]; FIG. 4H, see “Calibrate”) and the current measurement value taken at a second time (FIG. 4H, see “Detect”; paragraph [0095]). While Star discusses the use of lookup tables, algorithms, and formulas to determine information about an amount or concentration of THC, they do not specifically disclose determining a time window of cannabinoid use based on a comparison of the first and second measurement values.
However, DeGregorio teaches a comprehensive breath test that confirms recent use of inhaled cannabis within an impairment window wherein multiple cannabinoids are measured (see “Table 2”) across two breath measurements separated by a known time interval (Section: “Introduction”, paragraph 3) using a breath collection apparatus (Section: “Discussion”, paragraph 8) and the patterns of the presence of different cannabinoids at different time periods gives insight into when cannabis products were consumed (see “Table 2”; “≤ 60 min after smoking” and “> 60 min after smoking”).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified Star as modified, which includes a cannabinoid breath detection system with a plurality of sensor elements, with the teaching of DeGregorio that multiple cannabinoids and cannabinoid metabolites can be measured and that the presence of specific cannabinoids and cannabinoid metabolites can be mapped to a time window of cannabinoid use, because both Star and DeGregorio are interested in confirming recent use of inhaled cannabinoids and DeGregorio specifies that monitoring multiple cannabinoids allows for the prevention of false positives of cannabinoid usage (Section: “Introduction”; paragraphs 2 – 3).
While Star discloses a breath collection system and DeGregorio further teaches that breath measurements can be taken at a first and second time in order to assess amounts of cannabinoids in the breath, neither Star not DeGregorio discuss comparing data of a first time with data of a second time to determine a time window of cannabinoid use based on the comparison.
However, Degregorio ‘649 teaches a pharmacological model for determining the last use of inhaled and oral cannabis products where concentrations of cannabinoids are identified from blood tests taken at two measurement times and the various levels of THC and other cannabinoid indicators such as cannabinol (CBN) and cannabichromene (CBG) are compared to determine the time of last cannabis use (paragraphs [0031] – [0032]). While Degregorio ‘649 is directed towards a blood testing method, one of ordinary skill in the art would recognize that the same analysis could be applied to measured levels of cannabinoids using breath testing methods.
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified Star as modified, which includes a system for detecting cannabinoids in breath with a sensor device and measurement circuit and taking a breath measurement at a first and second time as taught by Degregorio, with the teachings of Degregorio ‘649 that includes a processing method of comparing measured cannabinoid levels to determine the time of last cannabis use because Star emphasizes the need for a method to test for cannabis or THC intoxication (paragraph [0003]) and Degregorio ‘649 further teaches that their system and method for determining the recent use of cannabis allows for determining recent use of cannabis without penalizing those who test positive for prior cannabis use but are not currently impaired by cannabis use (paragraph [0012]).
In regard to claim 2, Star as modified discloses the invention of claim 1. DeGregorio further teaches a comprehensive breath test that confirms recent use of inhaled cannabis within an impairment window wherein multiple cannabinoids and cannabinoid metabolites are measured (see “Table 2”) across two breath measurements separated by a known time interval (Section: “Introduction”, paragraph 3) and the patterns of the presence of different cannabinoids at different time periods gives insight into when cannabis products were consumed (see “Table 2”; “≤ 60 min after smoking” and “> 60 min after smoking”).
In regard to claim 5, Star as modified discloses the invention of claim 1. Star further discloses a plurality of sensor elements to measure a variable relatable to the at least one property of the sensor medium which is dependent upon the presence of THC where each sensor element includes at least one nanostructure (paragraph [0009]). Star further discloses that the nanostructure comprises holey reduced graphene oxide (paragraphs [0007] & [0099]; FIG. 10A).
In regard to claim 7, Star as modified discloses the invention of claim 1. Star further discloses that the sensor device comprises a graphene element, such as nanostructures comprising holey reduced graphene oxide (paragraphs [0007] & [0099]; FIG. 10A), wherein a compound or coating material is disposed on the surface of the graphene element that interacts with cannabinoid molecules such that an electrical or optical property of the sensing medium or material changes in a measurable manner (paragraph [0098]).
In regard to claim 10, Star as modified discloses the invention of claim 1. Star further discloses that the data reflects the amount or concentration of cannabinoid, such as THC (paragraph [0004]).
In regard to claim 11, Star as modified discloses the invention of claim 1. DeGregorio further teaches a comprehensive breath test that confirms recent use of inhaled cannabis within an impairment window wherein multiple cannabinoids and cannabinoid metabolites are measured (see “Table 2”) and the presence of different cannabinoids at different time periods gives insight into when cannabis products were consumed (see “Table 2”; “≤ 60 min after smoking” and “> 60 min after smoking”).
In regard to claims 12 and 13, Star as modified discloses the invention of claim 1. DeGregorio further teaches a comprehensive breath test that confirms recent use of inhaled cannabis within an impairment window wherein multiple cannabinoids and cannabinoid metabolites are measured where the cannabinoids and cannabinoid metabolites, including THC, cannabichromene (CBC), cannabinol (CBN), and cannabigerol (CBG), have different calculated half-lives in vivo (see “Table 3”).
In regard to claims 14 and 18, Star as modified discloses the invention of claims 1 and 15. Star further discloses that the system is configured to estimate cannabinoid metabolite amounts such as a concentration of THC (paragraph [0004]).
In regard to claim 19, Star as modified discloses the invention of claim 15. DeGregorio further teaches a comprehensive breath test that confirms recent use of inhaled cannabis within an impairment window wherein levels of cannabinoids including THC are determined by collecting two breath samples separated by a known time interval (Section: “Introduction”, paragraph 3; see Supplementary Table S7).
Claims 3, 4, 16, & 17 are rejected under 35 U.S.C. 103 as being unpatentable over Star (US 20230309920 A1 – Cited By Applicant) in view of DeGregorio (DeGregorio M., et al. A comprehensive breath test that confirms recent use of inhaled cannabis within the impairment window. Sci Rep. 2021;11(1):22776. Published 2021 – Cited by Applicant) and Degregorio ‘649 (WO 2019209649 A1) as applied to claim 1, and further in view of Tran (US 20190086432 A1 – Cited By Applicant).
In regard to claims 3 and 16, Star as modified discloses the invention of claims 1 and 15. Star further discloses that the measurement circuit is configured to provide a voltage stimulus to the sensor device, such as a nanotube field-effect transistor device, which measures electrical current through carbon nanotubes under an applied gate voltage to measure changes in an electrical property of the nanotube upon exposure to one or more chemical analytes (paragraph [0063]). While Star indicates that different electrical properties of the sensor device, such as conductance or resistance, change in response to the exposure to one or more chemical analytes (paragraph [0063]), they do not specify that the measurement circuit measures resulting capacitance values.
However, Tran teaches a system and method for non-invasive drug testing that includes a sensor device (FIG. 1, component 100) with a measurement circuit (FIG. 1, see “ELECTRONIC CIRCUITRY”) that measures changes in an electrical property including capacitance, resistance, or impedance (paragraph [0014]) to determine a level of THC (paragraph [0011]).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the system and method disclosed by Star as modified, which includes a measurement circuit for determining a change in an electrical property of a sensor when exposed to a cannabinoid, with the teaching of Tran, that includes a measurement circuit for determining a change in capacitance of a sensor to determine a level of a cannabinoid, because it would be considered a simple substitution of one known element for another, in this case the measurement circuits disclosed by Star and taught by Tran, to obtain the predictable result of determining a level of cannabinoid in the breath.
In regard to claims 4 and 17, Star as modified discloses the invention of claims 3 and 16. Star further discloses that voltage stimulus is applied as function of a swept or varied gate voltage range to measure an electrical property (paragraph [0066]).
Claims 6 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Star (US 20230309920 A1 – Cited By Applicant) in view of in view of DeGregorio (DeGregorio M., et al. A comprehensive breath test that confirms recent use of inhaled cannabis within the impairment window. Sci Rep. 2021;11(1):22776. Published 2021 – Cited by Applicant) and Degregorio ‘649 (WO 2019209649 A1) as applied to claims 5 and 15, and further in view of Sherwood (US 20180336970 A1).
In regard to claim 6, Star as modified discloses the invention of claim 5. While Star discloses the use of holey reduced graphene oxide nanostructures to measure a variable relatable to the at least one property of the sensor medium which is dependent upon the presence of THC where each sensor element includes at least one nanostructure (paragraphs [0009] & [0099]), they do not specify that the graphene sensor elements comprise graphene varactors.
However, Sherwood teaches a system and method for evaluating an analyte in a breath or gas sample of a patient using a plurality of graphene sensor elements (paragraph [0007]) where the graphene sensor elements comprise graphene varactors (paragraphs [0096] – [0097]) that are used to detect a change in electrical properties in response to the binding of an analyte of interest (paragraph [0099]).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date to have modified the system and method disclosed by Star as modified, which includes a plurality of graphene sensor elements to measure at least one property of the sensor medium which is dependent upon the presence of an analyte captured in the breath, with the teaching of Sherwood that includes the use of graphene varactors to detect a change in electrical properties in response to the binding of an analyte of interest, because it would be considered simple substitution of one element, in this case the graphene sensor elements disclosed by Star, for another, the graphene varactors taught by Sherwood, to obtain the predictable results of measuring at least one electrical property of the sensor medium which is dependent upon the presence of an analyte captured in the breath.
In regard to claim 20, Star as modified discloses the invention of claim 15. While Star discloses the use of holey reduced graphene oxide nanostructures to measure a variable relatable to the at least one property of the sensor medium which is dependent upon the presence of THC where each sensor element includes at least one graphene nanostructure (paragraphs [0009] & [0099]), they do not specify that the graphene sensor elements comprise graphene varactors.
However, Sherwood teaches a system and method for evaluating an analyte in a breath or gas sample of a patient using a plurality of graphene sensor elements (paragraph [0007]) where the graphene sensor elements comprise graphene varactors (paragraphs [0096] – [0097]) that are used to detect a change in electrical properties in response to the binding of an analyte of interest (paragraph [0099]).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date to have modified the system and method disclosed by Star as modified, which includes a plurality of graphene sensor elements to measure at least one property of the sensor medium which is dependent upon the presence of an analyte captured in the breath, with the teaching of Sherwood that includes the use of graphene varactors to detect a change in electrical properties in response to the binding of an analyte of interest, because it would be considered simple substitution of one element, in this case the graphene sensor elements disclosed by Star, for another, the graphene varactors taught by Sherwood, to obtain the predictable results of measuring at least one electrical property of the sensor medium which is dependent upon the presence of an analyte captured in the breath.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Star (US 20230309920 A1 – Cited By Applicant) in view of DeGregorio (DeGregorio M., et al. A comprehensive breath test that confirms recent use of inhaled cannabis within the impairment window. Sci Rep. 2021;11(1):22776. Published 2021 – Cited by Applicant) and Degregorio ‘649 (WO 2019209649 A1) as applied to claim 7, and further in view of Lynn (US 20200300876 A1 – Cited By Applicant).
In regard to claim 8, Star as modified discloses the invention of claim 7. While Star discloses that the sensor device comprises a graphene element with a compound or coating material disposed on the surface of the graphene element that interacts with cannabinoid molecules such that an electrical or optical property of the sensing medium or material changes in a measurable manner (paragraph [0098]), they do not specify that the compound comprises at least one selected from the group consisting of pyrenes, coronenes, aromatic cyclodextrins, and pillarenes.
However, Lynn teaches a system and method for evaluating a THC level from a breath sample including a sensor that includes the use of surface-based reporters and amine-functionalized fluorophore such as pyrene to generate an optical property and measure the amount of THC in the sample (paragraphs [0102] – [0109]).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified Star as modified, which includes a sensor device with a graphene element with a compound disposed on the surface of the graphene element, with the teaching of Lynn, that a compound on a sensor comprises a pyrene to generate an optical property and measure the amount of THC in the sample (paragraphs [0102] – [0109]), because Star already indicates that a compound that produces changes in an electrical or optical property of the sensing medium in a measurable manner is disposed on the surface of the graphene element of the sensor device such that the modification of Star as modified with the teachings of Lynn would be considered simple substitution of one known element, in this case the compound disclosed by Star, for another, in this case the pyrene coating of Lynn, to obtain the predictable results of measuring a THC level in a sample.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Star (US 20230309920 A1 – Cited By Applicant) in view of DeGregorio (DeGregorio M., et al. A comprehensive breath test that confirms recent use of inhaled cannabis within the impairment window. Sci Rep. 2021;11(1):22776. Published 2021 – Cited by Applicant) and Degregorio ‘649 (WO 2019209649 A1) as applied to claim 7, and further in view of Afzali-Ardakani (US 20140162375 A1).
In regard to claim 9, Star as modified discloses the invention of claim 7. While Star discloses that the sensor device comprises a graphene element, such as nanostructures comprising holey reduced graphene oxide (paragraphs [0007] & [0099]; FIG. 10A), wherein a compound or coating material is disposed on the surface of the graphene element, they do not specify that the compound is in the form of a self-assembling monolayer.
However, Afzali-Ardakani teaches a carbon-based biosensor for detecting a target molecule and the manufacturing of said carbon-based biosensor (Abstract), where the carbon-based biosensor comprises a channel surface with carbon or graphene nanostructures with an imidazolidone compound and at least one additional functionality that self-assembles on the carbon surface for the immobilization of a target analyte (paragraph [0022]).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the system disclosed by Star as modified, which includes carbon based sensors with graphene nanostructures wherein a compound or coating material is disposed on the surface of the graphene element, with the teaching of Afzali-Ardakani that includes a self-assembling coating layer formed over a carbon surface, because doing so allows the biosensor to selectively immobilize the target analyte for analysis and improves specificity of the sensor (paragraphs [0022] – [0023]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SIENNA CHRISTINE PYLE whose telephone number is (703)756-5798. The examiner can normally be reached 8 am - 5:30 pm M - T; Off first Fridays; 8 am - 4 pm second Fridays.
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/ERIC F WINAKUR/Primary Examiner, Art Unit 3791
/S.C.P./Examiner, Art Unit 3791
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