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 .
Election/Restrictions
Applicant’s election of Invention I in the reply filed on 02/05/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 9-12 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 02/05/2026.
Status of Claims
Claims 1-8 and 15-18 are hereby under examination.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 03/20/2023, 05/16/2023, 06/24/2024, 10/29/2025, and 03/03/2026 are being considered by the examiner.
Claim Warnings
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 Interpretation - 35 USC § 112(f)
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 1: 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”.
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.
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 § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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, and 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Nothacker et al. (US 20200237301 A1), hereinafter referred to as Nothacker, in view of James Macemon (US 20180335428 A1), hereinafter referred to as Macemon.
The claims are generally directed towards a method for determining impairment of a subject at a data collection location comprising: (a) collecting 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 stimuli, wherein the pupillometric and vital sign parameters are detected with an eye scanning instrument and included parameters associated with impairment; (b) 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; (c) measuring concentration in the obtained biological sampled matrix of the one or more metabolites by conducting a receptor binding assay or a live cell assay; and (d) analyzing the collected autonomic nervous system data and metabolite concentration with one or more instruments to determine the probability of the subject’s impairment.
Regarding claim 1, Nothacker discloses a method for determining impairment of a subject at a data collection location (Abstract, “method … monitoring a user’s intoxication …”, para. [0002]) comprising:
(a) collecting 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 stimuli, wherein the pupillometric and vital sign parameters are detected with an eye scanning instrument and included parameters associated with impairment (Fig. 1A, element s130, 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 …”);
(b) 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 …”);
(c) measuring 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
(d) analyzing the collected autonomic nervous system data and metabolite concentration 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 measure the concentration of the one or more metabolites (para. [0030], [0045-0046], [0079-0081]). However, Nothacker does not explicitly disclose measuring concentration of the one or more metabolites by conducting a receptor binding assay or a live cell assay.
Macemon teaches an analogous method of measuring a concentration of one or more metabolites (Abstract, para. [0002]). Macemon further teaches measuring concentration of the one or more metabolites by conducting a receptor binding assay or a live cell 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 or a live cell assay, as taught by Macemon. This is because Macemon teaches receptor biding assay or a live cell 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 where steps (a), (b), (c) and (d) are 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 step (c) comprises conducting the receptor binding assay or a live cell assay with a disposable cartridge.
Macemon further teaches conducing the receptor binding assay or a live cell 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 or a live cell 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 step (c) comprises running test sequences of visible 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. [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 …”).
Claims 7 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Nothacker et al. (US 20200237301 A1), hereinafter referred to as Nothacker, in view of James Macemon (US 20180335428 A1), hereinafter referred to as Macemon as applied to claim 1 above, and further in view of Macknik et al. (US 20170049362 A1), hereinafter referred to as Macknik.
Regarding claim 7, modified Nothacker discloses the method of claim 1 wherein step (a) comprises automatically measuring one or more of pupillometric parameters with the 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]).
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jason M Sims can be reached at (571)272-7540. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/K.W.K./Examiner, Art Unit 3791
/JASON M SIMS/Supervisory Patent Examiner, Art Unit 3791