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 .
Information Disclosure Statement
The accompanying information disclosure statement (IDS) submission(s) is/are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Interpretation
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.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception of an abstract without significantly more, wherein the claimed method steps of eye testing may be considered the abstract idea of a mental process.
For independent claims 1 and 13, the claim(s) recite(s) a process of performing a pupillary stimulus threshold test on a subject’s eye by delivering a flash of light visual stimulus, obtaining a pupillary response of contraction or not, and determining the lowest intensity light causing the pupil to contract based on the response. Claim 13 further recite(s) obtaining a volitional response whether the light was perceived.
As broadly as claimed these steps may be reasonably considered as the judicial exception of an abstract idea comprising a mental process performable within the human mind, including by observation, evaluation, judgement and opinion forming, or by a human using pen and paper (see MPEP 2106.04(a)(2) subsection III). For example, at least, these limitations are nothing more than a medical professional capturing data, printing it out, and using the data to mentally extract, classify or learn from data features to determine a pupil response to light thresholds. Further, physicians, ophthalmologists, neurologists, and field sobriety officers routinely evaluate pupillary responses to light purely mentally to arrive at determinations. Even the layperson evaluates blinking due to flashes during routine sunny conditions pictures and/or flash photography while observing pupil response.
This judicial exception is not integrated into a practical application because the process steps as broadly as claimed are not tied to nor required to be performed, executed, or programmed on a special purpose computer. Further, the judicial exception is not even required to be performed on or tied to a mere generic processing device, controller, or the like. Lastly, even read in light of the instant Specification, the claimed invention does not appear to require any structure(s) explicitly, implicitly, and/or even inherently implied by the claim limitations, beyond the delivering of light.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the preliminary steps of applying a light with an intensity and duration are well-known, routine and conventional, amounting to insignificant pre-solution activity as stimulation and/or data gathering.
Depending claims 2-12 and 14-20 inherit and do not remedy the non-statutory deficiency noted above. Despite further specifying steps relating to stimulus application, noise removal, recording, plotting, light delivery parameters, noise floor calculations, categorizations, using a camera, and/or detecting blinking, the additional specificity does not integrate into a application nor does it include additional elements amounting to significantly more than the abstract idea that may be accomplished mentally and/or by pen and paper.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Park et al. (11/5/24 IDS cite no 19, “Park et al., Toward a Clinical Protocol for Assessing Rod, Cone, and Melanopsin Contributions to the Human Pupil Response, Investigative Ophthalmology & Visual Science, Volume 52, No. 9, August 2011, 6624-6635.”, and hereinafter Park).
For claim 1, Park discloses a method for performing a pupillary stimulus threshold test on at least one eye of a test subject (Pg 6624), the method comprising:
delivering at least one visual stimulus (Figs 1-3) (Pgs 6624-6626) to the at least one eye of the test subject, wherein the least one visual stimulus comprises a flash of light having an intensity and a duration (Figs 1-3) (Pgs 6624-6626);
obtaining at least one pupillary response from the at least one eye of the test subject (Figs 1-3) (Pgs 6624-6626), wherein the at least one pupillary response corresponds to whether or not the test subject's pupil contracted in response to the at least one visual stimulus (Figs 1-3) (Pgs 6624-6626); and
determining the lowest intensity of light that causes the test subject's pupil to contract based on the at least one pupillary response from the test subject (Figs 2-6, esp 4) (Pgs. 6625-6629, esp 6629).
For claim 2, Park discloses the method of claim 1 wherein determining the lowest intensity of light that causes the test subject's pupil to contract comprises delivering a plurality of flashes of light having different intensities (Pg 6624) to the at least one eye of the test subject so as to generate a data set comprising data points corresponding to measurements of the diameter of the test subject's pupil after delivery of the plurality of flashes of light (Figs 1-6) (Pgs 6624-6635);
calculating a noise floor level of the pupillary responses of the at least one eye of the test subject (Pg 6625, 6632, 6634), wherein the noise floor level comprises the lowest intensity of light that causes the test subject's pupil to contract (Figs 1-6) (Pgs 6624-6635);
removing all but one data point from the data points below the noise floor level, wherein the one data point retained from the data points below the noise floor level corresponds to the diameter of the pupil measured after delivery of the brightest flash of light amongst the data points below the noise floor level (Figs 1-6) (Pgs 6624-6635);
recording the intensity of the brightest flash of light (Figs 1-6) (Pgs 6624-6635);
removing data points corresponding to intensities of flashes of light above a predetermined intensity from the data set (Figs 1-6) (Pgs 6624-6635);
plotting the remaining data points on a graph such that the intensity of the flashes of light occupies one axis and the pupillary response associated with each flash of light occupies a second axis (Figs 1-6) (Pgs 6624-6635);
applying a linear curve fit to the data points plotted on the graph so as to generate a linear curve (Figs 1-6) (Pgs 6624-6635); and
determining the point at which the linear curve crosses the axis of the graph occupied by the intensity of the flashes of light (Figs 1-6), wherein the point at which the curve crosses the axis of the graph occupied by the intensity of the flashes of light comprises the lowest intensity of light that causes the test subject's pupil to contract (Figs 1-6) (Pgs 6624-6635).
For claim 3, Park discloses the method of claim 2 wherein calculating the noise level comprises measuring the diameter of the pupil before a visual stimulus is delivered to the at least one eye of the test subject (Figs 1-6) (Pgs 6624-6635).
For claim 4, Park discloses the method of claim 2 wherein calculating the noise level comprises measuring the diameter of the pupil in response to a dim visual stimulus delivered to the at least one eye of the test subject (Figs 1-6) (Pgs 6624-6635).
For claim 5, Park discloses the method of claim 1 wherein determining the lowest intensity of light that causes the test subject's pupil to contract comprises delivering a plurality of flashes of light having different intensities to the at least one eye of the test subject so as to generate a data set comprising data points corresponding to measurements of the diameter of the test subject's pupil after delivery of the plurality of flashes of light (Figs 1-6) (Pgs 6624-6635);
calculating a noise floor level of the pupillary response of the at least one eye of the test subject based on the data set (Figs 1-6) (Pgs 6624-6635);
categorizing each data point of the data set into either a "yes" category or a "no" category, wherein the data points classified into the "yes" category are those data points corresponding to pupil contractions that are above the noise floor level, and wherein the data points classified into the "no" category are those data points corresponding to pupil contractions that are below the noise floor level (Figs 1-6) (Pgs 6624-6635);
plotting the data points corresponding to the "yes" category on a graph such that the intensity of the flashes of light occupies one axis and the probability of contraction associated with each flash of light occupies a second axis (Figs 1-6) (Pgs 6624-6635);
applying a Weibull curve fit (Pg 6625) to the data points plotted on the graph so as to derive a Weibull fit (PG 6625); and
determining an intensity threshold representing a N% chance of a measurable pupil contraction by determining where the Weibull fit crosses the axis representative of N% probability (Figs 1-6) (Pgs 6624-6635).
For claim 6, Park discloses the method of claim 1 wherein a plurality of flashes of light are delivered to the at least one eye of the test subject (Figs 1-6) (Pgs 6624-6635), wherein the plurality of flashes of light comprises different intensities and different durations (Figs 1-6) (Pgs 6624-6635).
For claim 7, Park discloses the method of claim 1 further comprising performing at least one of a full-field stimulus threshold (FST) test and a Dark Adaptometry ("DA") test (Figs 1-6) (Pgs 6624-6635, esp 6625).
For claim 8, Park discloses the method of claim 1 further comprising using a camera to detect a blink of the at least one eye of the test subject (Figs 1-6) (Pgs 6624-6635, esp 6625).
For claim 9, Park discloses the method of claim 8 wherein upon detection of the blink at the same time as the flash, rejecting the pupillary response following the blink (Figs 1-6) (Pgs 6624-6635, esp 6625).
For claim 10, Park discloses the method of claim 9 wherein after rejecting the at least one pupillary response, re-delivering the at least one visual stimulus to the at least one eye of the test subject (Figs 1-6) (Pgs 6624-6635, esp 6625).
For claim 11, Park discloses the method of claim 1 wherein the intensity of the at least one flash of light varies each time a flash of light is delivered to the at least one eye of the test subject (Figs 1-6) (Pgs 6624-6635).
For claim 12, Park discloses the method of claim 1 further comprising generating a graph, wherein the intensity of the at least one flash of light occupies one axis of the graph and the at least one pupillary response associated with the at least one flash of light occupies a second axis of the graph (Figs 1-6) (Pgs 6624-6635, esp 6625).
For claim 13. A method for performing a psychophysical stimulus threshold test on at least one eye of a test subject (Pg 6624), the method comprising:
delivering at least one visual stimulus to the at least one eye of the test subject (Figs 1-3) (Pgs 6624-6626), wherein the at least one visual stimulus comprises a flash of light having an intensity and a duration (Figs 1-3) (Pgs 6624-6626);
obtaining at least one pupillary response from the at least one eye of the test subject (Figs 1-3) (Pgs 6624-6626), wherein the at least one pupillary response corresponds to whether or not the test subject's pupil contracted in response to the at least one flash of light (Figs 1-3) (Pgs 6624-6626);
obtaining at least one volitional response from the test subject (Pg 6625), wherein the at least one volitional response corresponds to whether the test subject perceived a flash of light when the at least one flash of light was delivered to the at least one eye of the test subject (Figs 1-3) (Pgs 6624-6626); and
using the pupillary response to modify at least one testing condition of the psychophysical stimulus threshold test (Figs 1-3) (Pgs 6624-6626).
For claim 14, Park discloses the method of claim 13 wherein at least one of (i) the at least one pupillary response from the test subject, and (ii) the at least one volitional response from the test subject is used to determine the lowest intensity of light that causes the test subject's pupil to contract in response to the at least one flash of light (Figs 1-6) (Pgs 6624-6635, esp 6625).
For claim 15, Park discloses the method of claim 13 wherein modifying at least one testing condition comprises delivering an additional flash of light to the at least one eye of the test subject (Figs 1-6) (Pgs 6624-6635, esp 6625), wherein the additional flash of light is a repeat of a previously delivered flash of light to the at least one eye of the test subject (Figs 1-6) (Pgs 6624-6635, esp 6625).
For claim 16, Park discloses the method of claim 13 further comprising discarding at least one of (i) the at least one pupillary response from the test subject, and (ii) the at least one volitional response from the test subject prior to determining the lowest intensity of light that causes the test subject's pupil to contract in response to the at least one flash of light (Figs 1-6) (Pgs 6624-6635, esp 6625).
For claim 17, Park discloses the method of claim 13 further comprising for the same flash of light delivered to the test subject, analyzing (i) the at least one pupillary response from the test subject (Figs 1-6) (Pgs 6624-6635, esp 6625), and (ii) the at least one volitional response from the test subject to determine consistencies and inconsistencies in the at least one pupillary response and the at least one volitional response (Figs 1-6) (Pgs 6624-6635, esp 6625), wherein the consistencies and inconsistencies are used to measure the quality of the psychophysical stimulus threshold test (Figs 1-6) (Pgs 6624-6635, esp 6625).
For claim 18, Park discloses the method of claim 13 further comprising using a camera to detect a blink of the at least one eye of the test subject (Figs 1-6) (Pgs 6624-6635, esp 6625).
For claim 19, Park discloses the method of claim 18 wherein upon detection of the blink, rejecting the at least one pupillary response following the blink (Figs 1-6) (Pgs 6624-6635, esp 6625).
For claim 20, Park discloses the method of claim 19 wherein after rejecting the at least one pupillary response, re- delivering the at least one flash of light to the at least one eye of the test subject (Figs 1-6) (Pgs 6624-6635, esp 6625).
Conclusion
The cited prior art made of record on the accompanying PTO-892 and not relied upon is considered pertinent to applicant's disclosure, relating to means for measuring/processing/quantifying pupil response and diameter changes to varying light input in addition to obtaining user response throughout same.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jeffrey G. Hoekstra whose telephone number is (571)272-7232, Park discloses the examiner can normally be reached Monday through Thursday from 5am-3pm EST.
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, Charles A. Marmor II can be reached at (571)272-4730, Park discloses 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.
Jeffrey G. Hoekstra
Primary Examiner
Art Unit 3791
/JEFFREY G. HOEKSTRA/ Primary Examiner, Art Unit 3791