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 .
Notice of Reply
This communication is responsive to the amendment(s) and/or argument(s) filed 12/8/25. The previous ground(s) of objection and/or rejection is/are withdrawn. The following new and/or reiterated ground(s) of rejection is/are set forth hereinbelow.
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 1-6, 8-15, 17-31, 41 and 44 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea (testing a human’s visual or neurological function may be considered a mental process) without significantly more.
For independent claim 1, the claim(s) recite(s) a process of testing a human’s visual or neurological function by receiving a subject’s user input response to visual stimuli and analyzing the subject response with a sensitivity function that correlates with stimulus intensity. As broadly as claimed these steps may be reasonably considered as the judicial exception of 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 observing, capturing data, printing it out, and mentally analyzing a subject’s feedback to determine a subject’s responsiveness.
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, no output and/or result from analysis appears provide in any tangible or useable format.
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 providing a display and input and displaying sets of cells in sets of grids with different and varying intensities are well-known, routine and conventional amounting to insignificant data gathering as pre-solution activity. Further, the preliminary additional elements are also 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.
Depending claims 2-6, 8-15, 17-31, 41 and 44 inherit and do not remedy the non-statutory deficiency noted above, despite further specifying abstract idea steps, the steps do not integrate the abstract idea into a practical application and/or, despite further specifying additional elements, the additional elements do not amount to significantly more, when reciting at least the following steps/elements: relating to analysis, comparison, identification, displayed stimulus particulars, subject response, sensitivity function evaluation, stimuli sensitivity relationships, well-known user input devices, testing frequency/location, and/or disease progression monitoring. Similar to above, the abstract idea steps may be performed mentally, do not integrate into a practical application, and the additional elements do not amount to significantly more than the abstract idea.
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) 1-6, 8-12, 17, 20, 26-31, 41 and 44 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bex et al. (US 2015/0150444 A1, hereinafter Bex).
For claim 1, Bex discloses a method for testing a visual or neurological function of a human subject (Figs 1-2G, 4-6) ([0029-0099]), the method comprising:
(a) providing a device (600) having a graphical display (610) and a user input (620);
(b) displaying sequentially a set of grids on the display (Figs 4-5a) ([0029-0099]), each grid comprising a plurality of cells (Figs 4-5a) ([0029-0099]); wherein each grid comprises a visual stimulus displayed in two or more of the cells of the grid (Figs 4-5a) ([0029-0099]); wherein the visual stimulus displayed within a grid varies in intensity from cell to cell (Figs 4-5a) ([0029-0099]); and wherein the stimulus displayed for each grid differs from the stimulus displayed for at least one other grid of the set (Figs 4-5a) ([0029-0099]);
(c) receiving subject responses through the user input, the responses indicating a perceived characteristic of the stimulus for each cell of each displayed grid (Figs 1-2G, 4-6) ([0029-0099]); and
(d) analyzing the subject responses from each grid using a sensitivity function to obtain the subject's responsiveness to each of the stimuli in the set of grids, said responsiveness characterized as a probability of reporting the stimulus as a function of stimulus intensity (Figs 1-2G, 4-6) ([0029-0099]).
For claim 2, Bex discloses the method of claim 1, further comprising: (e) analyzing the subject's responsiveness to two or more of the stimuli of the set of grids to obtain a pattern of responsiveness of the subject (Figs 1-2G, 4-6) ([0029-0099]).
For claim 3, Bex discloses the method of claim 2, further comprising:
(f) comparing the subject's pattern of responsiveness to one or more known patterns of responsiveness (Figs 1-2G, 4-6) ([0029-0099]); and
(g) identifying a presence or absence in the subject, or a likelihood thereof, of one or more visual or neurological conditions (Figs 1-2G, 4-6) ([0029-0099]).
For claim 4, Bex discloses the method of claim 1, wherein the perceived characteristic of the stimulus comprises one or more stimulus characteristics selected from the group consisting of absence, presence, luminance, contrast, color, depth, motion, flicker, spatial form, object recognition, object shape, object form, object size, facial recognition, facial feature recognition, feature position, feature angle, spatial resolution, noise-defined depth, and sparse-pattern depth (Figs 1-2G, 4-6) ([0029-0099]).
For claim 5, Bex discloses the method of claim 1, wherein the stimulus intensity within a grid spans a range from difficult to detect to easy to detect for the subject (Figs 1-2G, 4-6) ([0029-0099]).
For claim 6, Bex discloses the method of claim 1, wherein a position of stimulus-containing within the grid is random or non-random (Figs 1-2G, 4-6) ([0029-0099]).
For claim 8, Bex discloses the method of claim 1, wherein format of one or more grids comprises a variable number of rows and columns (Figs 1-2G, 4-6) ([0029-0099]).
For claim 9, Bex discloses the method of claim 1, wherein one or more grids are displayed for each stimulus (Figs 1-2G, 4-6) ([0029-0099]).
For claim 10, Bex discloses the method of claim 1, wherein stimulus type or stimulus intensity within a particular grid are varied from an earlier presented grid based upon the subject responses (Figs 1-2G, 4-6) ([0029-0099]).
For claim 11, Bex discloses the method of claim 1, wherein the subject responds for each cell of a particular grid whether the stimulus is present or not present in the cell (Figs 1-2G, 4-6) ([0029-0099]), and wherein the subject's sensitivity to the stimulus displayed in each grid is calculated (Figs 1-2G, 4-6) ([0029-0099]).
For claim 12, Bex discloses the method of claim 1, wherein the subject indicates a degree of confidence in their response for each cell based on a position of their response or a secondary response (Figs 1-2G, 4-6) ([0029-0099]).
For claim 17, Bex discloses the method of claim 1, wherein individual cells comprise two or more stimuli, and the subject’s response comprises discrimination between the two or more stimuli (Figs 1-2G, 4-6) ([0029-0099]).
For claim 20, Bex discloses the method of claim 1, wherein sensitivity to one or more of the stimuli can vary in two or more dimensions (Figs 1-2G, 4-6) ([0029-0099]), and wherein a known relationship exists between said one or more stimuli and two or more types of subject sensitivity thereto (Figs 1-2G, 4-6) ([0029-0099]).
For claim 26, Bex discloses the method of claim 1, wherein the subject provides responses using a touch- sensitive display screen, computer pointing device, or speech recognition software (Figs 1-2G, 4-6) ([0029-0099]).
For claim 27, Bex discloses the method of claim 1, wherein the method is supervised or self-administered by the subject outside of a medical facility, vision testing facility, or doctor's office (Figs 1-2G, 4-6) ([0029-0099]).
For claim 28, Bex discloses the method of claim 1, wherein the method is repeated after one or more time intervals (Figs 1-2G, 4-6) ([0029-0099]).
For claim 29, Bex discloses the method of claim 1, wherein the method is used to detect and/or monitor progression of an ophthalmic disease or condition, an optometric condition, or a neurologic disease or condition (Figs 1-2G, 4-6) ([0029-0099]).
For claim 30, Bex discloses the method of claim 29, wherein the ophthalmic disease or condition is selected from the group consisting of age-related macular degeneration and other disorders of early visual neural pathways; diabetic retinopathy; color vision deficit; glaucoma; and amblyopia (Figs 1-2G, 4-6) ([0029-0099]).
For claim 31, Bex discloses the method of claim 29, wherein the optometric condition is selected from the group consisting of myopia, hyperopia, astigmatism and other optical aberrations of lower and higher order; presbyopia; and cataract, corneal edema, and other changes in optical opacity (Figs 1-2G, 4-6) ([0029-0099]).
For claim 41, Bex discloses the method of claim 29, wherein the neurologic disease or condition is selected from the group consisting of concussion, traumatic brain injury, traumatic eye injury, and other types of neurological trauma; cognitive impairment, Autism Spectrum Condition (ASC), Attention Deficit Disorder (ADD), and other high level neurological disorders; and schizophrenia, depression, bipolar disorder, and other psychotic disorders (Figs 1-2G, 4-6) ([0029-0099]).
For claim 44, Bex discloses the method of claim 29, wherein said detection and/or monitoring of the progression of an ophthalmic condition, an optometric condition, or a neurologic disease or condition comprises analysis of a pattern of sensitivities (Figs 1-2G, 4-6) ([0029-0099]).
Response to Arguments
Applicant's arguments filed 12/8/25 have been fully considered but they are not persuasive. Applicant argues the following:
Regarding the 101:
The present claims recite a method of testing a live human subject using specific displays on a computer screen and collection of data based on responses of the subject. The method can only be performed in the real world, and cannot be performed in an abstract sense or in the mind, or by a simple calculation based upon collected data. The responses of the human subject are based on the visual apparatus of the subject as well as the subject's brain and mind. The subject's responses are to an extent subjective and can be influenced by previously displayed stimuli or adjacently displayed stimuli. The subject's responses can be influenced by neurological and psychological conditions of the subject, including disease conditions. Thus, the claimed method involves many real world aspects, some of which involve complex operation and interaction of intricate physical structures, anatomy, and physiology.
The abstract aspect of the claimed method involves certain statistical evaluations that aid in extracting significant results from practice of the method. However, the methods require much, much more than the use of abstract statistical relationships and mathematical functions. Further, the claimed method relies heavily upon specifically structured physical displays and sequences of displays in order to test the subject's sensitivity to various types of visual stimuli. These are not mere insignificant data gathering steps; they are integral aspects of the invention.
Thus, the claimed method involves significantly more than an abstract idea, and represents patentable subject matter. The withdrawal of the rejection is respectfully requested.
In response to applicant's argument regarding the 101, the Examiner respectfully disagrees and notes the following:
In response to applicant's argument that the claimed invention is statutory, it is noted that the features upon which applicant relies (i.e., “computer screen”, “collection of data”, “performed in the real world”, “complex operations and interaction of intricate physical structures, anatomy, and physiology”, “statistical evaluations”, “extracting significant results”, and/or “specially structured physical displays”) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
In response to applicant's argument that the claimed invention is statutory, the Examiner respectfully notes that:
The analysis of subject responses may be performed mentally as broadly as claimed because the claim(s) are not tied to nor required to be performed, executed, or programmed on a special purpose computer, let alone even a generic processing device. The analysis step is not integrated into a practical application, not linked to any structure(s) and could be reasonably performed entirely within the mind of an individual, such as a medical professional trained in visual or neurological function assessment, and no output and/or result from analysis appears claimed in any tangible or useable format.
The display, user input steps, and response reception steps are similarly completely devoid of any link to special purpose computer, let alone even a generic processing device.
Conversely, and especially as broadly as claimed, these merely require a well-known, routine and conventional generic display used which is considered an additional element that does not amount to significantly more than the abstract idea. User input and reception may be merely completed verbally as broadly as claimed.
Regarding the 102:
Bex '444 completely fails to disclose, or even suggest, each of the bolded features of step (b). (i) Bex '444 does not disclose displaying a grid containing a plurality of cells, or a set of such grids.
(ii) Bex '444 does not disclose displaying a common visual stimulus in cells of a grid, wherein the intensity of the visual stimulus varies in intensity from cell to cell. (iii) Bex '444 does not disclose wherein the type of visual stimulus is different for at least one grid of the set from other grids of the set. These are key aspects of the method, because they allow the subject being tested to easily compare the stimulus intensity from cell to cell and to react to each stimulus intensity in a manner that allows significant parameters, such as the subject's detection threshold for the stimulus, to be determined. Thus use of such grids and sets of grids also allow progressive testing from grid to grid and testing of several different types of stimulus in a sequential set of tests, each using a common presentation paradigm.
The rejection refers to Bex '444 as teaching sequential display of a set of grids on a display, each grid comprising a plurality of cells of the grid at Figs. 4-5a and somewhere in [0029]-[0099] (which is the entire Detailed Description). However, careful review of the Bex '444 figures and text reveal that this is not the case; no such display of grids containing cells is presented, discussed, or even suggested. The word "grid" appears four times in Bex '444, and each instance represents a statistical parameter, not an aspect of display or presentation to a subject.
In response to applicant's argument regarding the 102, the Examiner respectfully disagrees and notes the following:
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., “in a manner that allows significant parameters, such as the subject's detection threshold for the stimulus, to be determined”) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Bex explicitly states inter alia (emphasis added):
[0034] Referring again to FIG. 1, one or more second parameters defining a second visual sensitivity are determined at 130 using the one or more first parameters and a statistical inference. The one or more second parameters are determined by at least presenting a first visual stimulus, receiving a response, and determining a second visual stimulus using the response and at least a rule. The presenting a first visual stimulus, receiving a response, and determining a second visual stimulus using the response and at least a rule can be performed iteratively to determine the one or more second parameters. The one or more second parameters can be provided at 140. Providing the one or more second parameters can include one or more of transmitting to another device, displaying at a monitor or screen, storing in memory, and/or performing calculations.
[0035] A statistical inference is a process of drawing conclusions from data that is subject to random variation, for example, observational errors or sampling variation. Frequentist inference and Bayesian inference are example classes of statistical inference. Bayesian inference is a method of inference in which Bayes' rule is used to update the probability estimate for a hypothesis as additional evidence is learned. In an example, when Bayesian inference is used, the one or more second parameters are determined by updating the one or more first parameters, which serve as a priori probabilities. The updated parameters can be iteratively updated using new information until a stopping criterion (e.g., a number or updates, or a confidence in the precision of the parameters) is reached.
[0036] In this manner, a subjective contrast sensitivity judgment can be used to seed the Bayesian prior for a subsequent objective test. A first visual test result or prior that is easy to collect, and represents the specific individual about to be tested, can provide a valuable starting point to accelerate the assessment by the objective task. For example, having a subject trace out the transition between visible and invisible on an image (e.g., FIG. 2A and FIG. 2B) provides preliminary estimates of contrast sensitivity, including information about the peak sensitivity and peak frequency.
[0037] The first visual stimulus and the second visual stimulus can be determined to help improve an estimate of the visual sensitivity of a user. The first visual stimulus and second visual stimulus can include one or more of band-pass frequency stimulus, band-pass frequency letters, and localized windowed grating. The first visual stimulus and second visual stimulus can include a flickering band-pass filtered letter. The temporal frequency of the flickering and the spatial frequency of the band-pass filtered letter can vary between the first visual stimulus and the second visual stimulus. Band-pass filtered letters can be selected from any number of letters. Pre-literate children can benefit from a four-letter version (e.g., Landolt C or Tumbling E), while traditional ten letter Sloan subset or twenty six letters for the entire alphabet can be used. Using more letters lowers guessing rate, and can improve the convergence rate of probability estimates.
[0038] FIG. 4 is a process flow diagram 400 illustrating a method of determining the one or more second parameters. A first visual stimulus is selected at 410. The selection is based on previously determined parameters (e.g., the first parameters). The first visual stimulus is a band-pass frequency stimulus and the previously determined parameters characterize a probability. The first visual stimulus can be presented at 420. The presenting can be to a user or subject. A response relating to the first visual stimulus is received at 430. The probability can update according to Bayes rule and based on the received response at 440. The process can iterate until a stopping criterion is satisfied at 450.
[0039] FIG. 5A is a diagram illustrating a dynamic band-pass letter chart that can be used as a visual stimulus. Traditional letter charts are printed on paper media; therefore, the test stimuli are static and pre-determined. The dynamic contrast sensitivity chart illustrated includes three rows of band-pass filtered letters at varying spatial frequencies and temporal frequencies. The dynamic band-pass letter chart can also be flickered at constant or varying rates. FIG. 5B is a diagram illustrating an example of a spatio-temporal contrast sensitivity surface. Temporal frequency is shown in the vertical axis and spatial frequency is shown in the horizontal axis. The spatio-temporal contrast sensitivity surface can also be dynamic and flicker at constant or varying rates. A dynamic contrast sensitivity chart can provide a better assessment of functional vision that can be more important for predicting reading and mobility. A dynamic contrast sensitivity chart can provide a better assessment of functional vision. An adaptive algorithm can adjust the size (e.g. spatial frequency), flicker (e.g. temporal frequency), and contrast of the letters to gain information about a user's contrast sensitivity.
[0045] Rapid and accurate visual sensitivity measurements can be used to assess visual sensitivity in a number of settings that were previously difficult to measure. For example, contrast sensitivity can be measured at different visual field locations, in different illumination conditions, in photopic and mesopic conditions, and at two or more levels of external illumination noise. FIG. 7 illustrates the results of measuring visual sensitivity dynamics under illumination changes. Rapidly measuring sensitivity can provide multiple measurements in different visual conditions. Each panel of FIG. 7 presents CSFs obtained from two individuals with normal vision (710) and one with impaired vision (720; Stargardt's disease) under photopic illumination (solid) and the transition to mesopic illumination (dashed) within minutes.
[0046] FIG. 8 presents the spatial contrast sensitivities measured for one observer, for low (810) and high (820) retinal eccentricities along the four cardinal directions of the visual field. Contrast sensitivity functions were measured at different eccentricities along the horizontal and vertical meridians of the visual field. A horizontal shifting between functions measured at different eccentricities provides an approximation to the data. This can provide for the measurement of multiple contrast sensitivities across a range of spatial frequencies.
[0047] The current subject matter, may, in some implementations, provide precise contrast sensitivity assessment that is flexible enough to measure normal and impaired vision over broad ranges of illumination, eccentricity, temporal frequencies, and/or external noise conditions.
[0058] The ability to rapidly measure a single contrast sensitivity function makes it possible to measure several contrast sensitivity functions within a short amount of time. A more complete assessment of functional vision can involve measuring CSFs across different testing conditions: e.g., measuring CSFs at different spatial and temporal frequencies, in different eyes, at different visual field locations, in different illumination conditions (photopic vs mesopic), along different dimensions of cone color contrast space (red-green vs blue-yellow), different levels of external glare, and different levels of external noise. FIG. 7 presents spatial, temporal, and spatiotemporal sensitivity functions obtained in photopic (solid line) and mesopic (dashed line) illumination, for two observers with normal (710) vision and one with impaired vision (720; Stargardt's disease). Using 15 trials of data collection per function (<2 minutes), classical patterns of contrast sensitivity as a function of illumination are obtained. For each subject, both the peak gain and peak frequency of contrast sensitivity functions are reduced when mesopic sensitivity is compared to photopic sensitivity; the shifts to lower peak gains and lower peak frequencies are apparent in FIG. 7 and FIG. 8. FIG. 8 presents the spatial contrast sensitivities measured for one observer, for low (810) and high (820) retinal eccentricities along the four cardinal directions of the visual field.
[0059] Measurement of contrast sensitivity under different external noise conditions can aid in assessing amblyopia, especially at high spatial frequencies. Measurement of contrast sensitivity under different external glare conditions can aid in assessing cataract. Measurement of contrast sensitivity during different luminance adaptation levels can aid in assessing the impairment caused by age-related macular degeneration.
[0060] Bayesian inference can be used to estimate the contrast sensitivity function and yield a measure of confidence that is implicitly defined in the full multi-dimensional probability distribution defined over CSF parameters. Taking samples from this posterior distribution, and calculating the AULCSF generated by the corresponding set of CSF parameters, generates a distribution of AULCSF estimates. This provides a useful estimate of the variability of AULCSF estimates obtainable from a single run; this approach differs from other measures that need test and retest to estimate variability.
[0061] Spatial scale of processing at a visual field location can be assessed by measuring CSFs with fixed-cycle grating stimuli. Measuring CSFs at different eccentricities can yield functions that exhibit the same shape and peak sensitivity, but are shifted relative to each other on the log-frequency axis. The relative shift between CSFs yield an estimate of spatial scale differences between the visual field locations and can be used to characterize contrast sensitivity across the visual field. The visual field CSF method can assess contrast sensitivity independently at different visual field locations.
[0062] Stimulus selection can be applied to find the multiple stimuli that most improve contrast sensitivity assessment by presentation of the set of stimuli to the subject. This strategy represents an attempt to find synergy between different stimuli. For example, finding the best stimulus to present twice (or more) is not the same as finding the best stimulus and just presenting it twice.
[0063] The local adjustment of stimulus intensity provided by adaptive staircases (e.g., 1-up/l-down, or 3-up/1-down) can produce a sequential dependence in many psychophysical data. The simulated annealing principles that help the stimulus selection algorithm applied by the quick CSF, which avoid local minima in its optimization, also produce greater independence between successive trials, and therefore makes it difficult for observers to reliably predict what the next stimulus will be.
Thus, as emphasized above and illustrated in copy below, Bex is explicitly concerned with displaying sequentially a set of grids on the display (Figs 4-5a) ([0029-0099]), each grid comprising a plurality of cells (Figs 4-5a) ([0029-0099]); wherein each grid comprises a visual stimulus displayed in two or more of the cells of the grid (Figs 4-5a) ([0029-0099]); wherein the visual stimulus displayed within a grid varies in intensity from cell to cell (Figs 4-5a) ([0029-0099]); and wherein the stimulus displayed for each grid differs from the stimulus displayed for at least one other grid of the set (Figs 4-5a) ([0029-0099]).
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Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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. 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. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Jeffrey G. Hoekstra
Primary Examiner
Art Unit 3791
/JEFFREY G. HOEKSTRA/ Primary Examiner, Art Unit 3791
Prosecution Insights