DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to judicial exceptions of abstract idea without significantly more. Claims 1-19 recite a pupillometer, which falls within one of statutory categories (i.e. machine) (Step 1: YES).
Step 2A Prong One analysis: Claim 1 recites “analyzing the pupillary light reflex data based on one or more characteristics of the subject; determining a probability of a concussion injury suffered by the subject”. The claim involves analysis of data and determination of probability constitutes an abstract idea of mathematical relationships/ calculations and/or mental process, which fall within at least one of the groupings of abstract ideas enumerated in the 2019 Revised Patent Subject Matter Eligibility Guidance (Mathematical Concepts) (Step 2A Prong One: YES).
Step 2A Prong Two analysis: Claim 1 recites “an optical assembly… comprising: a light source… and a detector… and a control device… comprising a controller… a digital memory”. Claim 16 recites “a display”. This judicial exception is not integrated into a practical application because the optical assembly of the pupillometer is considered as a data provider. There is no improvement or change in the function of the device (see at least MPEP 2106.05(a), (f) and (g)). And the “obtaining pupillary light reflex data during stimulation of the one or more pupils by the optical assembly and outputting the probability to a user of the pupillometer with a display are considered as conventional pupillometer data gathering/ outputting steps to be insignificant extra-solution activity. And/ or the abstract idea (mental process) is directed as being performed 1) on a generic computer, or 2) in a computer environment, or 3) is merely using a computer as a tool to perform the concept (see MPEP 2106.04(a)(2).III.C) “(Step 2A Prong Two: YES).
Step 2B: The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional element(s), when considered separately and in combination, are associated with data gathering/ outputting steps of insignificant extra-solution activity (see MPEP 2106.05(g)) and mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea (see MPEP 2106.05(f)) and do not improve the functioning of a computer, e.g. an improvement in the application of the mathematical relationship in determining the parameter(s), which is, itself, an abstract idea (see MPEP 2106.05(a)). The claims merely cover the collection of data obtained from known and existing technology and then using the data to make a correlation for parameter(s) (Step 2B: No). Dependent claims 2-19 further limit the judicial exception and/or are reciting elements that are well understood, routine, and conventional.
For these reasons, there is no inventive concept in the claims, and thus claims 1-19 are ineligible.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 15 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. In regard to claim 15, the claim recites “analysis of the pupillary light reflex data comprises stratifying risk of persistent post-concussion symptoms in the concussed subject. First of all, it is unclear whether “analysis of the pupillary light reflex data” refers to the analyzing function recited in claim 1 or it is an additional function. Clarification is requested by amendments. Secondly, “the concussed subject” lacks of sufficient antecedent basis.
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.
Claims 1-13 and 15-19 are rejected under 35 U.S.C. 103 as being unpatentable over Master, et al., "Utility of Pupillary Light Reflex Metrics as a Physiologic Biomarker for Adolescent Sport-Related Concussion", JAMA Ophthalmology, Vol. 138, No. 11, November 01, 2020, pp. E1-E7 (applicant cited) in view of Visconti (USPGPUB 2018/0184899). In regard to claim 1, Master disclose a portable pupillometer for evaluating one or more pupils of a subject (abstract; Neuroptics PLR-3000 handheld, infrared, automated, monocular pupillometer, instrumentation section, pages 1136-1137), the pupillometer comprising: an optical assembly configured to stimulate the one or more pupils (Neuroptics PLR-3000 handheld, infrared, automated, monocular pupillometer, instrumentation section, pages 1136-1137), the optical assembly comprising: a light source configured to deliver a stimulus to the one or more pupils (inherent property of Neuroptics PLR-3000 handheld, infrared, automated, monocular pupillometer, instrumentation section, pages 1136-1137); and a detector configured to capture images of the one or more pupils during delivery of the stimulus (inherent property of digital video of Neuroptics PLR-3000 handheld, infrared, automated, monocular pupillometer, instrumentation section, pages 1136-1137); and a control device coupled to the optical assembly (controller or processor of Neuroptics PLR-3000 handheld, infrared, automated, monocular pupillometer, instrumentation section, pages 1136-1137), the control device comprising a controller configured to perform a plurality of operations in accordance with instructions stored in a digital memory (software of Neuroptics PLR-3000 handheld, infrared, automated, monocular pupillometer, instrumentation section, pages 1136-1137), wherein the plurality of operations includes: obtaining pupillary light reflex data during stimulation of the one or more pupils by the optical assembly (PLR metrics, instrumentation section, pages 1136-1137; PLR metrics in Table 2 and associated descriptions, pages 1138-1139), the pupillary light reflex data comprising a plurality of Pupillary Light Reflex (PLR) metrics (PLR metrics, instrumentation section, pages 1136-1137; PLR metrics in Table 2 and associated descriptions, pages 1138-1139); analyzing the pupillary light reflex data based on one or more characteristics of the subject (sex, race/ethnicity, and history of prior concussion and age, Statistical Analyses/ PLR Metrics in Concussion/ Sex-Based Differences in the PLR in Concussion/ Age-Related Differences in the PLR in Concussion sections, pages 1137-1139).
Master does not specifically disclose determining a probability of a concussion injury suffered by the subject; and outputting the probability to a user of the pupillometer.
Visconti teaches a portable video capture device (Figs. 1-4, 13 and 17-18 and associated descriptions) comprises an optical assembly (Fig. 2 and associated descriptions) including a light source (element 206, Fig. 2 and associated descriptions), a video capture device (element 204, Fig. 2 and associated descriptions), a controller and associated memory (elements 212/216/218/224/226/228, Fig. 2 and associated descriptions), wherein the device obtains pupillary light reflex (PLR) data/ information of the user (Figs. 1-2, 4, 13 and 17-18 and associated descriptions; [0003-0004]; [0010-0011]; [0035]; [0074-0075]; [0080]); and determining a probability of a concussion injury suffered by the subject (relationship of PLR and concussion, [0003]; impairment associated with concussion, [0004] and [0035]; prediction/ probability, Fig. 1 and associated descriptions; probability and feature of the eye, [0039-0044]); and outputting the probability to a user of the device (Fig. 1 and associated descriptions; output resultant probability through a user interface/ display, [0039]).
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 pupillometer (Master) to incorporate the determining and output functions and associated elements/ analytical functions/ software as taught by Visconti, since both devices are pupillometers which obtain PLR information of user(s) and one of ordinary skill in the art would have recognized that concussion is related to PLR metrics and determination of the probability of concussion provides additional medical information of the user (see both Master and Visconti). The rationale would have been to provide additional medical information based on PLR data.
In regard to claim 2, Master as modified by Visconti discloses the plurality of PLR metrics includes an average constriction velocity of the one or more pupils (ACV) (Table 2 and associated descriptions of Master).
In regard to claim 3, Master as modified by Visconti discloses the plurality of PLR metrics includes a maximum constriction velocity of the one or more pupils (MCV) (peak constriction velocity, Table 2 and associated descriptions of Master).
In regard to claim 4, Master as modified by Visconti discloses the plurality of PLR metrics includes an average dilation velocity of the one or more pupils (ADV) (Table 2 and associated descriptions of Master).
In regard to claim 5, Master as modified by Visconti discloses the plurality of PLR metrics includes a maximum dilation velocity of the one or more pupils (MDV) (peak dilation velocity, Table 2 and associated descriptions of Master).
In regard to claim 6, Master as modified by Visconti discloses the plurality of PLR metrics includes a latency of constriction of the one or more pupils (LAT) (Table 2 and associated descriptions of Master).
In regard to claim 7, Master as modified by Visconti discloses the plurality of PLR metrics includes a percent constriction of the one or more pupils (CON) (% constriction, Table 2 and associated descriptions of Master).
In regard to claim 8, Master as modified by Visconti discloses the plurality of PLR metrics includes a time for redilation of the one or more pupils from a minimum diameter to 75% maximum diameter (T75) (T75, Table 2 and associated descriptions of Master).
In regard to claim 9, Master as modified by Visconti discloses the plurality of PLR metrics includes an initial pupil diameter of the one or more pupils (PDI) (initial pupil diameters, third paragraph on the left column of page 1136; maximum pupil diameter (steady-state pupil size before the light stimulus), instrumentation section on page 1136 of Master).
In regard to claim 10, Master as modified by Visconti discloses the plurality of PLR metrics includes an ending pupil diameter of the one or more pupils (PDE) (minimum pupil diameter (pupil size after maximum constriction in response to the light stimulus), instrumentation section on page 1136 of Master).
In regard to claim 11, Master as modified by Visconti discloses the one or more characteristics of the subject comprise the subject's age, sex, concussion history, or combination thereof (referring to claim 1 above).
In regard to claim 12, Master as modified by Visconti discloses the one or more characteristics of the subject include a length of time from an event causing the concussion injury to the subject (another study found differences acutely (<72 hours following injury) compared with control individuals, third paragraph of left column on page 1136; concussion within 28 days of injury, Age-Related Differences in the PLR in Concussion section on page 1139 of Master).
In regard to claim 13, Master as modified by Visconti discloses the length of time is less than 72 hours from the event causing the concussion injury to the head of the subject (another study found differences acutely (<72 hours following injury) compared with control individuals, third paragraph of left column on page 1136 of Master) but does not specifically disclose the time period is less than twenty four hours. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to try analyzing the relationship between concussion status after the time of injury, including less than 24 hours, and the PLR metrics analyses through experiments/ investigation in order to find the optimal relationship(s) between concussion status and PLR metrics. The rationale would have been “obvious to try”, see KSR International Co. v. Teleflex Inc., 550 USPQ2d 398, 421(2007).
In regard to claim 15, Master as modified by Visconti discloses analysis of the pupillary light reflex data comprises stratifying risk of persistent post-concussion symptoms in the concussed subject (rejected as best understood. Referring to the 35 USC112(b) rejection above; Statistical Analyses section on page 1137 of Master).
In regard to claim 16, Master as modified by Visconti discloses a display configured to output the probability to the user (referring to claim 1 above).
In regard to claim 17, Master as modified by Visconti discloses the one or more characteristics of the subject comprise the subject's age (referring to claims 1 and 11 above) and the plurality of PLR metrics comprise an initial pupil diameter of the one or more pupils (referring to claim 9 above).
In regard to claim 18, Master as modified by Visconti discloses the plurality of PLR metrics includes ACV, MCV, ADV, MDV, LAT, CON, T75, PDI, PDE, or a combination thereof (referring to claims 1-10 above).
In regard to claim 19, Master as modified by Visconti discloses the controller determines probabilities based on the plurality of PLR metrics (referring to claim 1 above) and the one or more characteristics of the subject (referring to claims 1-10 above), according to the list of: PDI, the subject's age; (3) MCV; (4) ACV; (5) MDV; (6) CON; (7) PDE; (8) T75; (9) ADV; (10) LAT; (11) the subject's concussion history, and (12) the subject's sex but does not specifically disclose assigns a decreasing predictive value according to the list of: PDI, the subject's age; (3) MCV; (4) ACV; (5) MDV; (6) CON; (7) PDE; (8) T75; (9) ADV; (10) LAT; (11) the subject's concussion history, and (12) the subject's sex. However, one of ordinary skill in the art would have recognized that the relationships of the one or more characteristics of the subject and PLR metrics are associated with the concussion status of the (see Master). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to try assigning a decreasing predictive value/ probability value according to the most to less related parameter(s) of each characteristics of the subject and each of PLR metrics, through experiments/ investigation, in order to find the optimal probabilities of concussion status based on these parameters.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of Master and Visconti as applied to claims 1-13 and 15-19 above, and further in view of Van Keuren-Jensen et al. (USPGPUB 2018/0306806). In regard to claim 14, Master as modified by Visconti discloses all the claimed limitations except the analysis of the pupillary light reflex data according to a random forest algorithm.
Van Keuren-Jensen teaches a random forest algorithm ([0027]) can be utilized to calculate probability scores of risk of concussion due to head impact conditions ([0027-0046]).
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 pupillometer (Master as modified by Visconti) to incorporate the random forest algorithm as taught by Van Keuren-Jensen, since both devices determine probabilities of concussion and one of ordinary skill in the art that random forest algorithm facilitates calculating probabilities of concussion based on parameters (see Van Keuren-Jensen). The rationale would have been to use a random forest algorithm to obtain additional analysis of probabilities of concussion based on the acquired parameters.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Finkel (USPGPUB 2015/0116665) teaches a device for measuring pupillary light reflex (PLR) with parameters of baseline pupil size and the maximally constricted size to generate the constriction amplitude (CON). The baseline pupul size is found before the flash of light and the maximally constricted size is determined after the flash of light. The dynamic responses to a flash of light including the velocity of constriction (average constriction velocity (ACV) and maximum constriction velocity (MCV)), the latency of constriction (LAT), and the velocity of re-dilation are other pupillometric measures. The various parameters of the PLR are impacted in a predictable way by various drugs and medical conditions ([0042]).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHU CHUAN LIU whose telephone number is (571)270-5507. The examiner can normally be reached M-Th (6am-6pm).
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, Jennifer Robertson can be reached at (571) 272-5001. 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.
/CHU CHUAN LIU/Primary Examiner, Art Unit 3791
Prosecution Insights