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 .
Status of Claims
Applicant's arguments, filed 06/03/2026, have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicants have amended their claims, filed 06/03/2026.
Applicants have amended claims 1-3, 7, and 8.
Applicants have left claims 4-6 and 15-18 as originally filed/previously presented.
Applicants have canceled/previously canceled claims 9-14.
Applicants have introduced new claims 19-24.
Claims 1-8 and 15-24 are the current claims hereby under examination.
Claim Warnings - Maintained
Applicant is advised that should claim 15 be found allowable, claim 16 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Objections – Newly Applied Necessitated by Applicant’s Amendments
Claims 1 and 24 are objected to because of the following informalities:
Regarding claim 1, line 14 recites “the collected pharmacodynamic and pharmacodynamic data”, however it appears it should read –the collected pharmacodynamic and pharmacokinetic data—(emphasis added).
Regarding claim 1, line 16 recites “the probability”, however it appears it should read --a probability-- (emphasis added).
Regarding claim 1, line 16 recites “the subject’s impairment”, however it appears it should read --the subject’s drug-induced impairment-- (emphasis added).
Regarding claim 24, lines 2-3 recite “analyzing both the collected pharmacodynamic and pharmacodynamic data”, however it appears it should read --analyzing both the collected pharmacodynamic and pharmacokinetic data-- (emphasis added).
Claim Interpretation - 35 USC § 112(f) – Modified Necessitated by Applicant’s Amendments
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
Claim 7: The claim limitation “automatically measuring one or more of the following pupillometric parameters with an eye scanning instrument …” has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses a generic placeholder “instrument” coupled with functional language “automatically measuring one or more of the following pupillometric parameters” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier that has a known structural meaning before the phrase “instrument”.
Claim 19: The claim limitation “pupillometric and vital sign parameters are detected with an eye scanning instrument” has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses a generic placeholder “instrument” coupled with functional language “pupillometric and vital sign parameters are detected” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier that has a known structural meaning before the phrase “instrument”.
Claim 24: The claim limitation “collecting pharmacodynamic data, collecting pharmacokinetic data and analyzing both the collected pharmacodynamic and pharmacodynamic data are effected in a portable eye scanner instrument” has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses a generic placeholder “instrument” coupled with functional language “collecting pharmacodynamic data, collecting pharmacokinetic data and analyzing both the collected pharmacodynamic and pharmacodynamic data” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier that has a known structural meaning before the phrase “instrument”.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
A review of the specification shows that the following appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation:
“hand-held pupillometric and vital sign measuring device … single-camera … embedded pulse sensor … visible and IR spectra by LEDs or other light source sensed by the camera …”, or equivalents thereof, as described in para. [0106-0108] of the disclosure filed on 11/23/2022.
“hand-held pupillometric and vital sign measuring device … single-camera … embedded pulse sensor … visible and IR spectra by LEDs or other light source sensed by the camera …”, or equivalents thereof, as described in para. [0106-0108] of the disclosure filed on 11/23/2022.
“hand-held pupillometric and vital sign measuring device … single-camera … embedded pulse sensor … visible and IR spectra by LEDs or other light source sensed by the camera …”, and “base station which hosts the system that process the pharmacodynamic and pharmacokinetic data … port allows for additional sensors to be installed on the base station as needed, for example a toxicology device” or equivalents thereof, as described in para. [0106-0108] and para. [0116] of the disclosure filed on 11/23/2022.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112(a) – Newly Applied Necessitated by Applicant’s Amendments
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.
Claim 8 is 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.
Regarding claim 8, the claim recites “wherein collecting pharmacokinetic data comprises running test sequences of the visible and/or auditory stimuli and gathering data on how a subject’s vital signs respond, said vital signs comprising one or more of heart rate, respiratory rate, blood pressure, body temperature, pupillary size, and pupillary position”. However, the instant specification, filed 11/23/2022, is clear “pharmacokinetic data” is “quantifiable levels of intoxicant metabolites and/or endogenous molecules. …” (para. [0081]), and “pharmacodynamic data” is “signatures of neurological function including, tonic and phase pupil size, eye movement, vital signs, and motor coordination” (para. [0081]), which includes “vital signs such as heart rate, blood pressure, and respiratory rate as well as the pupillary light response and pupillary positioning tests” (para. [0083]). That is, the specification does not describe in such a way as to reasonably convey to one skilled in the relevant art how pharmacokinetic data is utilized and collected based on a subject’s vital sign. The specification only recites how pharmacodynamic data is utilized and collected based on a subject’s vital sign. For the purposes of examination, the claimed “pharmacokinetic data” is being interpreted as “pharmacodynamic data”.
Claim Rejections - 35 USC § 101 – Newly Applied
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 1-8 and 15-24 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Analysis of independent claim 1:
Step 1 of the subject matter eligibility test (see MPEP 2106.03).
Claim 1 is directed to a method, which describes one of the four statutory categories of patentable subject matter, i.e., a process. Therefore, further consideration is necessary.
Step 2A of the subject matter eligibility test (see MPEP 2106.04).
Prong One: Claim 1 recites an abstract idea. In particular, the claim recites the following:
Analyzing both the collected pharmacodynamic and pharmacodynamic data to determine the probability of the subject’s impairment.
These elements required of claim 1 are drawn to an abstract idea since (1) they involve a mental process that can be practically performed in the human mind including observation, evaluation, judgment, and opinion and using pen and paper.
Analyzing collected pharmacodynamic and pharmacokinetic data (see objection above), to determine a probability of a subject’s impairment is drawn to a mental process that can practically be performed in the human mind, with the aid of pen and paper. For example, a person with ordinary skill in the art can reasonably view pharmacodynamic data and pharmacokinetic data on a piece of paper, and mentally and/or utilize a look up table to determine the probability of the subject’s impairment. There is nothing to suggest an undue level of complexity in the analyzing step.
Prong Two: Claim 1 does not recite additional elements that integrate the exception into a practical application. Therefore, the claims are “directed to” the abstract idea. The additional elements merely:
Recite the words “apply it” or an equivalent with the judicial exception, or include instructions to implement the abstract idea on a computer, or merely use the computer as a tool to perform the abstract idea (e.g., “one or more instruments”), and
Add insignificant extra-solution activity (the pre-solution activity of: using generic data-gathering components (e.g. “collecting pharmacodynamic data representing the subject’s autonomic nervous systems state by detecting changes in both pupillometric and vital sign parameters of the subject in response to programmed visible and/or auditory stimuli …”, “obtaining from the subject a biological sample matrix …”, and “collecting pharmacokinetic data in the formed of measured concentration in the obtained biological sample matrix …” – with no specific structure recited for all data gathering steps); the post-solution activity of: (e.g. N/A); using generic data-outputting components (e.g. N/A)).
As a whole, the additional elements merely serve to gather information to be used by the abstract idea, while generically implementing it on a computer. There is no practical application because the abstract idea is not applied, relied on, or used in a meaningful way. The processing performed remains in the abstract realm, i.e., the result is not used for a treatment. No improvement to the technology is evident. Therefore, the additional elements, alone or in combination, do not integrate the abstract idea into a practical application.
Per the Berkheimer requirement, the additional elements are well-understood, routine, and conventional.
For example, “collecting pharmacodynamic data representing the subject’s autonomic nervous systems state by detecting changes in both pupillometric and vital sign parameters of the subject in response to programmed visible and/or auditory stimuli …”, is well-understood, routine, and conventional as disclosed by Roshan et al. (US 20220386953 A1) – para. [0005], [0064-0065], [0072], [0164].
For example, “obtaining from the subject a biological sample matrix …” is well-understood, routine, and conventional, as disclosed by Nothacker et al. (US 20200237301 A1) – para. [0029].
For example, “collecting pharmacokinetic data in the form of measured concentration in the obtained biological sample matrix …” is well-understood, routine, and conventional, as disclosed by James Macemon (US 20180335428 A1) – para. [0035].
Further, “one or more instruments” (i.e., processors) does not qualify as significantly more because this limitation is simply appending well-understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014)) and/or a claim to an abstract idea requiring no more than being stored on a computer readable medium which is a well-understood, routine and conventional activity previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014); SAP Am. v. InvestPic, 890 F.3d 1016 (Fed. Circ. 2018)).
Step 2B of the subject matter eligibility test (see MPEP 2106.05).
Claim 1 does not include additional elements, alone or in combination, that are sufficient to amount to significantly more than the judicial exception (i.e., an inventive concept) for the same reasons as described above. E.g., all elements are directed to necessary pre-solution data gathering steps, which merely facilitate the abstract idea.
In view of the above, the additional elements individually do not integrate the exception into a practical application and do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations as an ordered combination (that is, as a whole) adds nothing that is not already present when looking at the elements taking individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process.
Analysis of the dependent claims:
Claims 2-8 and 15-24 depend from the independent claim. The dependent claims merely further define the abstract idea and are, therefore, directed to an abstract idea for similar reasons: they merely
Further describe the abstract idea (“the entire method is carried out at the data collection location” (claim 2), ),
Further describe the pre-solution activity (or the structure used for such activity) (“the reception binding assay is conducted with a disposable cartridge” (claim 3), “providing the disposable cartridge with the capacity to intake, process and/or interact with the biological sample matrix using one or more eukaryotic cell-based biosensors” (claim 4), “a disposable cartridge accepts, filters, optionally stores and prepares the biological sample matrix for interaction with the assay housed in a microfluidic or millifluidic chip, and wherein: the disposable cartridge gathers the biological sample matrix and, in the case of a saliva biological sample matrix, pre-filters larger particles from the biological sample matrix; and a mixer on the microfluidic or millifluidic chip that interacts the filtered biological saliva sample matrix with a buffer solution stored on the chip” (claim 6), “collecting pharmacodynamic data comprises automatically measuring one or more of the following pupillometric parameters with the an eye scanning instrument: lack of convergence, pupillary hippus, rebound dilation, vertical gaze nystagmus, and horizontal gaze nystagmus” (claim 7), “collecting pharmacokinetic data comprises running test sequences of the visible and/or auditory stimuli and gathering data on how a subject's vital signs respond, said vital signs comprising one or more of heart rate, respiratory rate, blood pressure, body temperature, pupillary size, and pupillary position” (claim 8), “the vital sign parameter includes one or more of heart rate, respiratory rate, blood pressure, and temperature” (claim 15 and claim 16), “the biological sample matrix is derived from the subject's saliva, blood, sweat, urine, breath or hair” (claim 17), “the pupillometric parameter is one or more of lack of convergence, pupillary hippus, rebound dilation, vertical gaze nystagmus, and horizontal gaze nystagmus; wherein the vital sign parameter includes one or more of heart rate, respiratory rate, blood pressure, and temperature; and wherein the biological sample matrix is derived from the subject's saliva, blood, sweat, urine, breath or hair” (claim 18), “wherein the pupillometric and vital sign parameters are detected with an eye scanning instrument” (claim 19), “collecting pharmacodynamic data includes optically scanning one or both eyes of the subject to detect changes in the pupillometric parameters of the subject in response to the programmed visible and/or auditory stimuli” (claim 20), “collecting pharmacodynamic data includes photoplethysmographically detecting vital sign parameters of the subject in response to the programmed visible and/or auditory stimuli” (claim 21), “collecting pharmacodynamic data includes optically scanning one or both eyes of the subject to detect changes in the pupillometric parameters of the subject in response to the programmed visible and/or auditory stimuli” (claim 22), “collecting pharmacodynamic data includes photoplethysmographically detecting vital sign parameters of the subject in response to the programmed visible and/or auditory stimuli” (claim 23), “collecting pharmacodynamic data, collecting pharmacokinetic data and analyzing both the collected pharmacodynamic and pharmacodynamic data are effected in a portable eye scanner instrument” (claim 24)),
Further describe the computer implementation (“transmitting data generated by the assay to a detector” (claim 5)), and
Further describe the post-solution activity (N/A) (recited at a high level of generality).
Per the Berkheimer requirement, the additional elements are well-understood, routine, and conventional.
For example, “disposable cartridges …”, and “microfluidic or millifluidic chips …” are well-understood, routine, and conventional, as disclosed by James Macemon (US 20180335428 A1) – para. [0026-0027], [0032], [0054], [0061], [0068-0069], [0071], [0087].
For example, “an eye scanning instrument …” is well-understood, routine, and conventional, as disclosed by Roshan et al. (US 20220386953 A1) – para. [0056], [0069].
Further, “a processor”, or equivalents of, does not qualify as significantly more because this limitation is simply appending well-understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014)) and/or a claim to an abstract idea requiring no more than being stored on a computer readable medium which is a well-understood, routine and conventional activity previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014); SAP Am. v. InvestPic, 890 F.3d 1016 (Fed. Circ. 2018)).
Taken alone or in combination, the additional elements do not integrate the judicial exception into a practical application at least because the abstract idea is not applied, relied on, or used in a meaningful way. The additional elements do not add anything significantly more than the abstract idea. The collective functions of the additional elements merely provide computer/electronic implementation and processing, and no additional elements beyond those of the abstract idea. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements improves the functioning of a computer, output device, improves technology other than the technical field of the claimed invention, etc. Therefore, the claims are rejected as being directed to non-statutory subjection matter. Claims 1-8 and 15-24 are rejected.
Claim Rejections - 35 USC § 103 – Newly Applied Necessitated by Applicant’s Amendments
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.
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.
Claims 1-6, 8, 15-17, 19, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Nothacker et al. (US 20200237301 A1) (previously cited), hereinafter referred to as Nothacker, in view of James Macemon (US 20180335428 A1) (previously cited), hereinafter referred to as Macemon.
The claims are generally directed towards a method for determining drug-induced impairment of a subject at a data collection location comprising: collecting pharmacodynamic data representing the subject’s autonomic nervous system state by detecting changes in both pupillometric and vital sign parameters of the subject in response to programmed visible and/or auditory stimuli, wherein the pupillometric and vital sign parameters include parameters associated with drug-induced impairment; obtaining from the subject a biological sampled matrix that is capable of being altered by the presence therein of one or more metabolites of an intoxicant and/or endogenous molecules; collecting pharmacokinetic data in the form of measured concentration in the obtained biological sampled matrix of the one or more metabolites by conducting a receptor binding assay; and analyzing both the collected pharmacodynamic and pharmacodynamic data with one or more instruments to determine the probability of the subject’s impairment.
Regarding claim 1, Nothacker discloses a method for determining drug-induced impairment of a subject at a data collection location (Abstract, “method … monitoring a user’s intoxication …”, para. [0002]) comprising:
collecting pharmacodynamic data representing the subject’s autonomic nervous system state by detecting changes in both pupillometric and vital sign parameters of the subject in response to programmed visible and/or auditory stimuli, wherein the pupillometric and vital sign parameters include parameters associated with drug-induced impairment (Fig. 1A, element s130, para. [0025], “generate a notification that can be provided to the user at a user interface …”, para. [0032], para. [0036], “sobriety task is preferable provided to the user at a user interface …”, para. [0042-0043], “receiving … a physiological state of the user … determined based upon any one or more of information related to … biometric information (e.g., heart rate, respiration rate, pupillometric information) … image and/or text data can be input by the user … electronic device comprises an image sensor …”, para. [0091], “supplementary sensing module … facilitate reception and/or generation of data … an image sensor … a biometric sensor …”);
obtaining from the subject a biological sampled matrix that is capable of being altered by the presence therein of one or more metabolites of an intoxicant and/or endogenous molecules (para. [0029-0030], “set of samples can be collected automatically and/or manually … breath samples, urine samples, blood samples, interstitial fluid samples, and any other suitable sample that can be used to assess the user’s intoxication …”);
collecting pharmacokinetic data in the form of measured concentration in the obtained biological sampled matrix of the one or more metabolites (para. [0029-0030], para. [0045-0046], “determining a set of values of an intoxication metric … determined from signals generated from one or more of: a breath sample, a urine sample, a blood sample, and any other suitable biological sample from the user …”); and
analyzing both the collected pharmacodynamic and pharmacodynamic data with one or more instruments to determine the probability of the subject’s impairment (para. [0042], “supplementary data set … increase the accuracy of the set of values of the intoxication metric …” para. [0045-0046], “determining a set of values of an intoxication metric … determined from signals generated from one or more of: a breath sample, a urine sample, a blood sample, and any other suitable biological sample from the user …”).
Nothacker teaches multiple different sensors can be used to collect and measure the concentration of the one or more metabolites (para. [0030], [0045-0046], [0079-0081]). However, Nothacker does not explicitly disclose collecting pharmacokinetic data in the form of measured concentration of the one or more metabolites by conducting a receptor binding assay.
Macemon teaches an analogous method of measuring a concentration of one or more metabolites (Abstract, para. [0002]). Macemon further teaches collecting pharmacokinetic data in the form of measured concentration of the one or more metabolites by conducting a receptor binding assay (para. [0030], para. [0035], para. [0046-0047]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the concentration measuring method disclosed by Nothacker to explicitly be performed by conducting a receptor binding assay, as taught by Macemon. This is because Macemon teaches receptor biding assay are suitable alternatives of processing a biological sample matrix, specifically from blood, saliva and urine (para. [0032]).
Regarding claim 2, modified Nothacker discloses the method of claim 1 wherein the entire method is carried out at the data collection location (Fig. 7A, element 200, para. [0073], para. [0076], “portability of the system … user can conveniently bring the sample receiving module wherever he/she goes …”).
Regarding claim 3, modified Nothacker discloses the method of claim 1.
However, modified Nothacker does not explicitly disclose wherein the receptor binding assay is conducted with a disposable cartridge.
Macemon further teaches conducting the receptor binding assay with a disposable cartridge (para. [0071]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the receptor binding assay to use a disposable cartridge, as taught by Macemon. This is because Macemon teaches disposable cartridges allow for single use, which reduces cross contamination (para. [0071]).
Regarding claim 4, modified Nothacker discloses the method of claim 3.
However, modified Nothacker does not explicitly disclose providing the disposable cartridge with the capacity to intake, process and/or interact with the biological sample matrix using one or more eukaryotic cell-based biosensors.
Macemon further teaches providing the disposable cartridge with the capacity to intake, process and/or interact with the biological sample matrix using one or more eukaryotic cell-based biosensors (para. [0012], para. [0027], para. [0035], para. [0068], para. [0076]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the disposable cartridge taught by modified Nothacker to explicitly be provided with the capacity to intake, processor and/or interact with the biological sample matrix using one or more eukaryotic cell-based biosensors, as taught by Macemon. This is because Macemon teaches a disposable cartridge with the capacity to intake and interact with the biological sample matrix with the biosensor allows for no manual technical operations, which allows for less human error (para. [0100]).
Regarding claim 5, modified Nothacker discloses the method of claim 1 further comprising transmitting data generated by the assay to a detector (para. [0025], “sampling receiving module configured to receive a set of samples from the user, a data link configured to communicate signals derived from the set of samples …”).
Regarding claim 6, modified Nothacker discloses the method of claim 1.
However, modified Nothacker does not explicitly disclose wherein a disposable cartridge accepts, filters, optionally stores and prepares the biological sample matrix for interaction with the assay housed in a microfluidic or millifluidic chip, and wherein: the disposable cartridge gathers the biological sample matrix and, in the case of a saliva biological sample matrix, pre-filters larger particles from the biological sample matrix; and a mixer on the microfluidic or millifluidic chip that interacts the filtered biological saliva sample matrix with a buffer solution stored on the chip.
Macemon further teaches a disposable cartridge accepts, filters, optionally stores and prepares the biological sample matrix for interaction with the assay housed in a microfluidic or millifluidic chip, and wherein: the disposable cartridge gathers the biological sample matrix and, in the case of a saliva biological sample matrix, pre-filters larger particles from the biological sample matrix; and a mixer on the microfluidic or millifluidic chip that interacts the filtered biological saliva sample matrix with a buffer solution stored on the chip (para. [0026-0027], para. [0032], para. [0054], para. [0061], para. [0068-0069], para. [0071], para. [0087]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method taught by modified Nothacker to additionally include a disposable cartridge accepts, filters, optionally stores and prepares the biological sample matrix for interaction with the assay housed in a microfluidic or millifluidic chip, and wherein: the disposable cartridge gathers the biological sample matrix and, in the case of a saliva biological sample matrix, pre-filters larger particles from the biological sample matrix; and a mixer on the microfluidic or millifluidic chip that interacts the filtered biological saliva sample matrix with a buffer solution stored on the chip, as taught by Macemon. This is because Macemon teaches a disposable cartridge that accepts, filters, stores, and prepares a biological sample matrix in a microfluidic chip, filters the biological sample matrix, and interacts with a buffer solution allows for unwanted particles from entering the cartridge, facilitates binding, and allows for a single structure with no external tubing (para. [0026-0027], para. [0032], para. [0054], para. [0061], para. [0068-0069], para. [0071], para. [0087]).
Regarding claim 8, modified Nothacker discloses the method of claim 1 wherein collecting pharmacokinetic data comprises running test sequences of the visible and/or auditory stimuli and gathering data on how a subject's vital signs respond, said vital signs comprising one or more of heart rate, respiratory rate, blood pressure, body temperature, pupillary size, and pupillary position (para. [0025], “generate a notification that can be provided to the user at a user interface …”, para. [0032], para. [0036], “sobriety task is preferable provided to the user at a user interface …”, para. [0042-0043], “physiological state of the user can be determined … biometric information (e.g., heart rate, respiration rate, pupillometric information) … supplementary dataset is generated by manual input”).
Regarding claim 15, modified Nothacker discloses the method of claim 1 wherein the vital sign parameter includes one or more of heart rate, respiratory rate, blood pressure, and temperature (para. [0042-0043], “receiving … a physiological state of the user … determined based upon any one or more of information related to … biometric information (e.g., heart rate, respiration rate, pupillometric information)”).
Regarding claim 16, modified Nothacker discloses the method of claim 1 wherein the vital sign parameter includes one or more of heart rate, respiratory rate, blood pressure, and temperature (para. [0042-0043], “receiving … a physiological state of the user … determined based upon any one or more of information related to … biometric information (e.g., heart rate, respiration rate, pupillometric information)”).
Regarding claim 17, modified Nothacker discloses the method of claim 1 wherein the biological sample matrix is derived from the subject's saliva, blood, sweat, urine, breath or hair (para. [0029], “breath samples, urine samples, blood samples, interstitial fluid samples …”).
Regarding claim 19, modified Nothacker discloses the method of claim 1 wherein the pupillometric and vital sign parameters are detected with an eye scanning instrument (para. [0091], “supplementary sensing module … facilitate reception and/or generation of data … biometric information (e.g., heart rate, respiration rate, pupillometric information, neural activity information, etc.) … any one or more of: an image sensor … a biometric sensor …”).
Regarding claim 24, modified Nothacker discloses the method of claim 1 wherein collecting pharmacodynamic data, collecting pharmacokinetic data and analyzing both the collected pharmacodynamic and pharmacodynamic data are effected in a portable eye scanner instrument (Fig. 7A, para. [0073], para. [0087], para. [00280] – all collecting and analyzing are effected by the portable system).
Claims 7 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Nothacker et al. (US 20200237301 A1) (previously cited), hereinafter referred to as Nothacker, in view of James Macemon (US 20180335428 A1) (previously cited), hereinafter referred to as Macemon as applied to claim 1 above, and further in view of Macknik et al. (US 20170049362 A1) (previously cited), hereinafter referred to as Macknik.
Regarding claim 7, modified Nothacker discloses the method of claim 1 wherein collecting pharmacodynamic data comprises automatically measuring one or more of pupillometric parameters with an eye scanning instrument (para. [0042-0043], “supplementary dataset … pupillometric information … generated … automatically …”).
However, modified Nothacker does not explicitly disclose the one or more pupillometric parameters are lack of convergence, pupillary hippus, rebound dilation, vertical gaze nystagmus, and horizontal gaze nystagmus.
Macknik teaches an analogous method for detecting the presence of intoxication (Abstract, para. [0009-0010]). Macknik further teaches measuring pupillometric parameters including lack of convergence, pupillary hippus, rebound dilation, vertical gaze nystagmus, and horizontal gaze nystagmus (para. [0033]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the pupillometric parameters taught by modified Nothacker to explicitly include one or more of lack of convergence, pupillary hippus, rebound dilation, vertical gaze nystagmus, and horizontal gaze nystagmus, as taught by Macknik. This is because Macknik teaches these eye movements can be analyzed to detect intoxication of the subject (para. [0002], para. [0033]).
Regarding claim 18, modified Nothacker discloses the method of claim 1: wherein the vital sign parameter includes one or more of heart rate, respiratory rate, blood pressure, and temperature (para. [0042-0043], “receiving … a physiological state of the user … determined based upon any one or more of information related to … biometric information (e.g., heart rate, respiration rate, pupillometric information)”); and wherein the biological sample matrix is derived from the subject's saliva, blood, sweat, urine, breath or hair (para. [0029], “breath samples, urine samples, blood samples, interstitial fluid samples …”).
However, modified Nothacker does not explicitly disclose wherein the pupillometric parameter is one or more of lack of convergence, pupillary hippus, rebound dilation, vertical gaze nystagmus, and horizontal gaze nystagmus.
Macknik teaches an analogous method for detecting the presence of intoxication (Abstract, para. [0009-0010]). Macknik further teaches the pupillometric parameter is one or more of lack of convergence, pupillary hippus, rebound dilation, vertical gaze nystagmus, and horizontal gaze nystagmus (para. [0033]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the pupillometric parameters taught by modified Nothacker to explicitly include one or more of lack of convergence, pupillary hippus, rebound dilation, vertical gaze nystagmus, and horizontal gaze nystagmus, as taught by Macknik. This is because Macknik teaches these eye movements can be analyzed to detect intoxication of the subject (para. [0002], para. [0033]).
Claims 20-23 are rejected under 35 U.S.C. 103 as being unpatentable over Nothacker et al. (US 20200237301 A1) (previously cited), hereinafter referred to as Nothacker, in view of James Macemon (US 20180335428 A1) (previously cited), hereinafter referred to as Macemon as applied to claim 1 and claim 19 above, and further in view of Roshan et al. (US 20220386953 A1), hereinafter referred to as Roshan.
Regarding claim 20, modified Nothacker discloses the method of claim 19.
However, modified Nothacker does not explicitly disclose wherein collecting pharmacodynamic data includes optically scanning one or both eyes of the subject to detect changes in the pupillometric parameters of the subject in response to the programmed visible and/or auditory stimuli.
Roshan teaches an analogous method for determining drug-induced impairment of a subject by collecting pharmacodynamic data and pharmacokinetic data (Abstract, Fig. 1A, para. [0065-0066], para. [0084-0090], para. [00148]). Roshan further teaches collecting pharmacodynamic data includes optically scanning one or both eyes of the subject to detect changes in the pupillometric parameters of the subject in response to the programmed visible and/or auditory stimuli (para. [0066-0068], para. [0084-0123]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method taught by modified Nothacker to additionally collect pharmacodynamic data by optically scanning one or both eyes of the subject to detect changes in the pupillometric parameters of the subject in response to the programmed visible and/or auditory stimuli, as taught by Roshan. This is because Roshan teaches optically scanning the eyes of the subject to detect changes in the pupillometric parameters based on visible stimuli is a known and reliable method for detecting if a subject is under the influence of drugs or alcohol (para. [0005], para. [0084-0123]).
Regarding claim 21, modified Nothacker discloses the method of claim 20.
However, modified Nothacker does not explicitly disclose wherein collecting pharmacodynamic data includes photoplethysmographically detecting vital sign parameters of the subject in response to the programmed visible and/or auditory stimuli.
Roshan further teaches collecting pharmacodynamic data includes photoplethysmographically detecting vital sign parameters of the subject in response to the programmed visible and/or auditory stimuli (para. [0055], para. [0065], para. [0069]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method taught by modified Nothacker to explicitly include photoplethysmographically detecting vital sign parameters of the subject in response to the programmed visible and/or auditory stimuli, as taught by Roshan. This is because Roshan teaches photoplethysmographically detecting vital sign parameters based on a stimuli is a known indicator for impairment if the heart rate is elevated (para. [0133]).
Regarding claim 22, modified Nothacker discloses the method of claim 1.
However, modified Nothacker does not explicitly disclose wherein collecting pharmacodynamic data includes optically scanning one or both eyes of the subject to detect changes in the pupillometric parameters of the subject in response to the programmed visible and/or auditory stimuli.
Roshan teaches an analogous method for determining drug-induced impairment of a subject by collecting pharmacodynamic data and pharmacokinetic data (Abstract, Fig. 1A, para. [0065-0066], para. [0084-0090], para. [00148]). Roshan further teaches collecting pharmacodynamic data includes optically scanning one or both eyes of the subject to detect changes in the pupillometric parameters of the subject in response to the programmed visible and/or auditory stimuli (para. [0066-0068], para. [0084-0123]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method taught by modified Nothacker to additionally collect pharmacodynamic data by optically scanning one or both eyes of the subject to detect changes in the pupillometric parameters of the subject in response to the programmed visible and/or auditory stimuli, as taught by Roshan. This is because Roshan teaches optically scanning the eyes of the subject to detect changes in the pupillometric parameters based on visible stimuli is a known and reliable method for detecting if a subject is under the influence of drugs or alcohol (para. [0005], para. [0084-0123]).
Regarding claim 23, modified Nothacker discloses the method of claim 1.
However, modified Nothacker does not explicitly disclose wherein collecting pharmacodynamic data includes photoplethysmographically detecting vital sign parameters of the subject in response to the programmed visible and/or auditory stimuli.
Roshan teaches an analogous method for determining drug-induced impairment of a subject by collecting pharmacodynamic data and pharmacokinetic data (Abstract, Fig. 1A, para. [0065-0066], para. [0084-0090], para. [00148]). Roshan further teaches collecting pharmacodynamic data includes photoplethysmographically detecting vital sign parameters of the subject in response to the programmed visible and/or auditory stimuli (para. [0055], para. [0065], para. [0069]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method taught by modified Nothacker to explicitly include photoplethysmographically detecting vital sign parameters of the subject in response to the programmed visible and/or auditory stimuli, as taught by Roshan. This is because Roshan teaches photoplethysmographically detecting vital sign parameters based on a stimuli is a known indicator for impairment if the heart rate is elevated (para. [0133]).
Response to Arguments
Applicant's arguments filed 06/03/2026 have been fully considered but they are not persuasive.
Applicants have argued on pages 12-14 of Remarks, filed 06/03/2026, that “Nothing in Nothacker’s disclosure extends the detected drug of impairment to cannabinoids, opioids, or any other, nor to the receptor pharmacology employed in Applicant’s methods”.
The examiner respectfully disagrees. Applicant’s arguments regarding “cannabinoids, opioids …” is not commensurate in scope with the claimed invention.
Applicants have argued on pages 14-15 of Remarks, filed 06/03/2026, that “claim 1 requires the active, dynamic collection of data representing involuntary responses … this information is used not to assess impairment, but rather to adjust the parameters of the BAC prediction model”.
The examiner respectfully disagrees. The claims currently do not limit or further define “visible and/or auditory stimuli”. As reiterated above, at least Nothacker discloses collecting pupillometric and vital sign parameters in response to a stimuli (i.e., a notification from the system) (para. [0025], para. [0032], para. [0036], para. [0042-0043], para. [0091]). Further, Nothacker explicitly discloses the pupillometric and vital sign parameters are utilized for an impairment prediction (para. [0042], “configured to use the supplementary dataset in generating a set of values of an intoxication metric”).
Applicants have argued on pages 15-16 of Remarks, filed 06/03/2026, that “the wrist-borne device image sensor … is not described as an eye scanner, does not administer light stimuli to elicit a pupillary light response, and does not collect the parameters required … the rejection has not identified any structure in Nothacker that performs, or that is capable of performing, the active stimulus-response pupillometry and vital sign assessment …”.
The Examiner respectfully disagrees. First, Applicants arguments are not commensurate in scope with the claimed invention. Claim 1 does not require “an eye scanner” that “administers light stimuli to elicit a pupillary light response” and/or “collect the parameters”. Further, as reiterated above, Nothacker explicitly discloses a system for collecting both pharmacodynamic and pharmacokinetic data, where the pharmacodynamic data is changes in both pupillometric and vital sign parameters in response to programmed visible and/or auditory stimuli. The claims currently do not recite or limit what “visible and/or auditory stimuli” is.
Applicants have argued on pages 17-18 of Remarks, filed 06/03/2026, that “Macemon does not in any way teach or suggest that one can measure analytes by conducting such a receptor binding assay”.
The Examiner respectfully disagrees. As reiterated above, Macemon explicitly discloses utilizing conducting a receptor binding assay for measuring a concentration of one or more metabolites in the obtained biological sample matrix (para. [0046]).
Applicants have argued on pages 18-19 of Remarks, filed 06/03/2026, that “substituting or supplementing a live cell receptor binding assay for/with a fuel cell breathalyzer is not a simple modification …”.
The Examiner respectfully disagrees. As reiterated in the rejection above, receptor binding assays are known and suitable alternatives for processing a sample matrix, specifically from blood, saliva, and urine (para. [0032]), and it therefore would have been obvious to one of ordinary skill in the art to substitute Nothacker’s metabolite concentration detection method for Macemon’s detection method.
Applicants have argued on pages 18-19 of Remarks, filed 06/03/2026, that “Nothacker and Macemon address diverse types of analytes … different sample matrices … and different sensing mechanisms …”.
The Examiner respectfully disagrees. Nothacker and Macemon address overlapping analytes (i.e., “alcohol” – Nothacker, para. [0003]; “drug” and “chemical substance” – Macemon, para. [0035]), overlapping sample matrices (i.e., “urine samples, blood samples …” – Nothacker, para. [0029]; i.e., “blood”, “saliva”, “urine” – Macemon, para. [0032]). Further, as reiterated above, receptor binding assay is a known and suitable alternative for processing a sample matrix from blood, saliva, and urine.
Applicants have argued on pages 19-21, of Remarks, filed 06/03/2026, that “Macknik’s pupillometry system is a passive monitoring system, not an active test instrument … fundamentally different from the applied active pharmacodynamic test battery recited in Applicant’s claims, wherein programmed visual and auditory stimuli are actively administered to the subject, and involuntary responses are measured … combining them would not be obvious”.
First, Applicants arguments are not commensurate in scope with the claimed invention. Second, as reiterated above, Macknik teaches specifics regarding what pupillometric parameters are measured for determining drug-induced impairment, not for teaching collecting pharmacodynamic data in response to programmed visible and/or auditory stimuli. Third, as reiterated above, Macknik is explicitly in the same field of endeavor of monitoring specific pupillometric parameters to determine a drug-induced impairment (para. [0028]), and as reiterated above, combing them would have been obvious by one of ordinary skill in the art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYLE W KRETZER whose telephone number is (571)272-1907. The examiner can normally be reached Monday through Friday 8:30 AM to 5:30 PM.
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/K.W.K./Examiner, Art Unit 3791
/JASON M SIMS/Supervisory Patent Examiner, Art Unit 3791
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