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 .
Response to Amendment
2. This action is responsive to the amendments filed 12/23/2025. Claims 17 and 50 have been amended. Claim 52 was newly added. Claim 30 was canceled.
Response to Arguments
Applicant’s arguments filed on 12/23/2025 with respect to the rejection under 35 USC 101 have been fully considered but they are not persuasive. In substance, applicant argues
A) The claims do not recite a mental process B) The claims integrate the judicial exception into a practical application and C) The claims recite additional elements that amount to significantly more than the judicial exception.
4. In response to A) the examiner respectfully disagrees.The method steps themselves can be practically carried out in the mind and/or by pen and paper. For instance, these steps can be practically carried out by a clinician receiving the measured pupil data on paper and then performing integration on paper to calculate the area under the curve of the measured pupil data corresponding to the measured pupil diameter over time within a duration between a time of peak acceleration and a time of peak dilation and then making a confirmation that a neurotransmitter system of the subject was activated. With regard to applicant’s contention that it would be impractical for a subject to sit while a medical professional conducts pen and paper calculus on a data set only to confirm if the subject’s neurotransmitter is activated, the Examiner notes that the claims as written set forth no time constraints and does not provide any minimum number of samples/data points required. Integration can be performed with as little as 2 or 3 data points and a human being is more than capable of doing an integral with at least 2 or 3 data points. Therefore, the claims still recite a mental process.
5. In response to B) the examiner respectfully disagrees.
At the onset, the Examiner notes that it is well established that the mere physical or tangible nature of additional elements does not automatically confer eligibility on a claim directed to an abstract idea (see Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S. 208, 224, 110 USPQ2d 1976, 1983-84 (2014)). The claims recite a generic computing device receiving data and performing a calculation (i.e. calculating an area under the curve) which is a mathematical calculation of performing integration and is also an abstract idea. The Examiner notes that merely using a computer and its generic components as a tool to perform an abstract idea does not integrate the abstract idea into a practical application (see MPEP 2016.05(f)). With regard to applicant’s contention that "applying one or more electrical pulses to an ear of a subject to stimulate an auricular branch of a vagus nerve of the subject" and "measuring, by a pupil measurement device, pupil diameter of the subject over time" are not pre-solution activity, but, rather, “part of the practical application of activating the neurotransmitter system, and then confirming the activation”, the Examiner notes that these steps are in fact pre-solution activity. Pre-solution activity is a step of gathering data for use in a claimed process (see MPEP 2106.05(g)). The calculation step of calculating an area under a curve requires measured pupil diameter data over time, which requires measuring the pupil over time. This by definition makes the measuring of the pupil over time pre-solution activity because it must happen before in order to obtain the data necessary to perform the calculation. In other words, it is the data gathering necessary to do the abstract idea.
Thus, these steps as claimed are directed to collecting data in extra-solution activity, performing the abstract process of performing a calculation, and confirming/determining results from the data collection which are directed to mental processes. As a result, the judicial exception is still not integrated into a practical application because there is no improvement to the functioning of a computer, or to any other technological field (see MPEP 2106.05(a)) and there is no application of the judicial exception in any other meaningful way beyond generally linking the judicial exception to a particular technological environment (e.g., the pupil measuring environment, vagus nerve activation environment, etc.). Furthermore, there is no evidence provided that there is an improvement to determining the activation of the vagus nerve. In essence, Applicant provides an explanation on how their invention works. Additionally, it is important to note, the judicial exception alone cannot provide the improvement (see MPEP 2106.05(a)). Furthermore, it is important to keep in mind that an improvement in the abstract idea itself is not an improvement in technology and an improvement to an abstract idea would still be an abstract idea.
6. In response to C) the examiner respectfully disagrees.
At the onset, the Examiner notes that it is well established that the mere physical or tangible nature of additional elements does not automatically confer eligibility on a claim directed to an abstract idea (see Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S. 208, 224, 110 USPQ2d 1976, 1983-84 (2014)). With regard to applicant’s contention that the additional elements are not merely generic recitations of computer hardware and that the additional elements are “not well-understood, routine, or conventional in the field”, the Examiner notes that the claims merely recite a generic “computing device” at a high-level of generality for receiving and calculating data. The Examiner further notes that the search for a 35 U.S.C. 101 inventive concept is distinct from demonstrating 35 U.S.C 102 novelty and different from an obviousness analysis under 35 U.S.C. 103 (see MPEP 2106.05). The additional element of applying stimulation to the nerve of an ear and measuring/confirming a response is well-understood, routine, and conventional as shown in at least Hyde et al. (US 2016/0279021 A1), Yoo et al. (US 2015/0148878 A1), and Simon et al. US 2013/0245486 A1). Additionally, Yoo in particular discloses applying electrical pulses as well as measuring pupil diameter. Furthermore, the additional element of measuring pupil diameter of a subject over time with a pupil measurement device is also well-understood, routine, and conventional as shown in at least Neice et al. (US 2021/0000339 A1), Hyde et al. (US 2011/0029038 A1), and Goodall et al. (US 2017/0113042 A1). Therefore, the claims do not recite additional elements that amount to significantly more than the judicial.
The 101 rejection is maintained and has been updated to reflect the amendments.
Claim Rejections - 35 USC § 101
7. 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.
8. Claims 17-21, 26-29, 36-38, 44-46, and 49-52 are rejected under 35 U.S.C 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1:
The claimed invention in claims 17-21, 26-29, 36-38, 44-46, and 49-52 are directed to statutory subject matter as the claims recite a method (i.e. a process). Thus, they are directed to statutory categories of invention (See MPEP 2106.03).
Step 2A – (Prong 1): Regarding claim 17, the limitations of “calculating, by the computing device, an area under a curve of data corresponding to the measured pupil diameter over time within a duration between a time of peak acceleration and a time of peak dilation” are mathematical calculations of performing integration in order to confirm the activation of a neurotransmitter system.
Regarding claim 17, the limitations of “providing an output indicative of the area under the curve to a medical professional” is a process, as drafted, covers performance of the limitation that are directed to organizing human activity (managing personal behavior or relationships or interactions between people including social activities, teaching, and following rules or instructions). For example, these limitations are nothing more than someone verbally communicating the area under a curve to a medical professional.
Furthermore, claim 17 recites a judicial exception by reciting the limitations of
“calculating, by the computing device, an area under a curve of data corresponding to the measured pupil diameter over time within a duration between a time of peak acceleration and a time of peak dilation and confirming activation of a neurotransmitter system of the subject based on the area under the curve”. These limitations, as drafted, is a process that, under its broadest reasonable interpretation covers performance of the limitation that can be performed by a human mind (including an observation, evaluation, judgment, opinion) or by a person using a pen and paper. For example, these limitations are nothing more than the clinician receiving the measured pupil data on paper and then performing integration on paper to calculate the area under the curve of the measured pupil data corresponding to the measured pupil diameter over time within a duration between a time of peak acceleration and a time of peak dilation and then making a confirmation that a neurotransmitter system of the subject was activated. Therefore, the claims are directed to a judicial exception (see MPEP 2106.04(a)(2)).
Step 2A – (Prong 2):
Regarding claim 17, the judicial exception is not integrated into a practical
application. Claim 17 recites the steps of “applying one or more electrical pulses to an ear of a subject to stimulate an auricular branch of a vagus nerve of the subject; measuring, by a pupil measurement device, pupil diameter of the subject over time; receiving, by a computing device, the pupil diameter of the subject over time” which amounts to nothing more than pre-solution activity of data gathering. The computing device is recited at a high-level generality and amounts to nothing more than a part of a generic computer. Merely including instructions to implement an abstract idea on a computer does not integrate a judicial exception into practical application. Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application.
Step 2B:
The claims do not include additional elements that are sufficient to amount to
significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional element of applying stimulation and then measuring with a pupil measurement device is nothing more than mere pre-solution activity of data gathering, which does not amount to an inventive concept. Moreover, applying stimulation to the nerve of an ear and measuring/confirming a response is well-understood, routine, and conventional as shown in Hyde et al. (US 2016/0279021 A1), Yoo et al. (US 2015/0148878 A1), and Simon et al. US 2013/0245486). Furthermore, measuring pupil diameter of a subject over time with a pupil measurement device is also well-understood, routine, and conventional as shown in Neice et al. (US 2021/0000339 A1), Hyde et al. (US 2011/0029038 A1), and Goodall et al. (US 2017/0113042 A1).
9. Regarding dependent claims 18-21, 26-29, 36-38, 44-46, and 49-52, the limitations of claim 17 further define the limitations already indicated as being directed to the abstract idea. While the dependent claims further define the abstract idea, it does not set forth any additional elements that integrate the claims into a practical application or add any additional elements that amount to significantly more than the abstract idea.
Thus, when considered as a whole and in combination, claims 17-21, 26-29, 36-38, 44-46, and 49-52 are directed to an abstracted idea and are therefore rejected.
Examiner’s Note on Claimed Subject Matter
Claims 17-21, 26-29, 36-38, 44-46, and 49-52 have been rejected under 35 U.S.C 101 (see 35 U.S.C 101 section above). The applicant is advised that no prior art was found teaching individually, or suggesting in combination claims 17-21, 26-29, 36-38, 44-46, and 49-52. Therefore, no art rejections have been made of claims 17-21, 26-29, 36-38, 44-46, and 49-52. The closest prior art of record are Alataris (International Publication No.: WO 2019/005774 A1) and Yoo (US Pub.: 2015/0148878 A1). Alataris is directed towards electrical stimulation of the vagus nerve. Yoo is directed towards electrical stimulation of the vagus nerve and measuring physiological responses. However, the prior art taken alone or in combination does not teach or disclose calculating an area under a curve of data corresponding to the measured pupil diameter over time within a duration between a time of peak acceleration and a time of peak dilation.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL TEHRANI whose telephone number is (571)270-0697. The examiner can normally be reached 9:00am-5:00pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached at 571-270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/D.T./Examiner, Art Unit 3792
/Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792