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 .
Response to Arguments
Applicant’s amendments and arguments with respect to claim(s) 1, 3, 5-14, and 17-20 as rejected under 35 U.S.C. §§ 101 and 103 have been fully considered and are persuasive. Applicant has amended independent claims 1, 13, and 20 to include “wherein the at least on physiological characteristic includes a respiration characteristic indicated by tidal respiration volume, and determining the tidal respiration volume comprises analyzing changes in pixelation between a nose region and a mouth region of the target individual in infrared image data over time.” The Remarks dated 6/25/2026, pp. 9-10 (with respect to the rejection under 35 U.S.C. § 101) and pp. 10-11 (with respect to the rejection under 35 U.S.C. § 103) are persuasive, in that the examiner agrees that the prior art does not fairly teach or suggest the claimed combination of features including determining tidal respiration volume by analyzing changes in pixelation between a nose region and a mouth region of the target individual in infrared image data over time. Further, these elements do not appear to reasonably be performable in the human mind, or with the aid of pen and paper.
However, these amendments merit new grounds for rejection under 35 U.S.C. § 112(a) as lacking adequate written description.
Drawings
The drawings are objected to because Figs. 2, 3, 6, 7A, 7B, 7C are scanned at a low resolution such that the text in the figures cannot be read. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 3, 5-14, and 17-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
In evaluation of the written description of claimed subject matter “wherein the at least on physiological characteristic includes a respiration characteristic indicated by tidal respiration volume, and determining the tidal respiration volume comprises analyzing changes in pixelation between a nose region and a mouth region of the target individual in infrared image data over time,” the examiner reviewed the originally filed disclosure and found the following description in Specification filed 9/19/2022:
[0050] At operation 406, the aggregated image data is analyzed to determine, for example, physiological and/or positioning data for the monitored patient. For example, using one or more algorithms as described herein, the image data is processed to determine the physiological and/or positioning data. For example, one or more different image processing techniques can be used to determine respiration, blood perfusion, heart rate, and ocular motion (or other bio-signals, such as temperature, brain activity, etc.), among others. In one example, the imaging data from the different imaging sensors is processed to detect pixelation, such as in the eyes, ears, cheeks, etc. of the patient. In some examples, the processing is performed on image data within a defined spectrum, such as the infrared (IR) spectrum (e.g., 350nm-750nm light spectrum). It should be noted that in various examples, calibration is automatically set, such as to distinguish between the background and the person (e.g., the patient).
…
[0053] As yet another example, changes in pixelation between the nose and mouth and changes in temperature can be analyzed to determine respiration, including tidal volume over time.
MPEP § 2161.01, I. provides the legal framework and guidance for this rejection (emphasis added):
When examining computer-implemented functional claims, examiners should determine whether the specification discloses the computer and the algorithm (e.g., the necessary steps and/or flowcharts) that perform the claimed function in sufficient detail such that one of ordinary skill in the art can reasonably conclude that the inventor possessed the claimed subject matter at the time of filing. An algorithm is defined, for example, as “a finite sequence of steps for solving a logical or mathematical problem or performing a task.” Microsoft Computer Dictionary (5th ed., 2002). Applicant may “express that algorithm in any understandable terms including as a mathematical formula, in prose, or as a flow chart, or in any other manner that provides sufficient structure.” Finisar Corp. v. DirecTV Grp., Inc., 523 F.3d 1323, 1340, 86 USPQ2d 1609, 1623 (Fed. Cir. 2008) (internal citation omitted). It is not enough that one skilled in the art could write a program to achieve the claimed function because the specification must explain how the inventor intends to achieve the claimed function to satisfy the written description requirement. See, e.g., Vasudevan Software, Inc. v. MicroStrategy, Inc., 782 F.3d 671, 681-683, 114 USPQ2d 1349, 1356, 1357 (Fed. Cir. 2015) (reversing and remanding the district court’s grant of summary judgment of invalidity for lack of adequate written description where there were genuine issues of material fact regarding “whether the specification show[ed] possession by the inventor of how accessing disparate databases is achieved”). If the specification does not provide a disclosure of the computer and algorithm in sufficient detail to demonstrate to one of ordinary skill in the art that the inventor possessed the invention a rejection under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, for lack of written description must be made.
The originally filed disclosure appears to lack any algorithm, flowchart, pseudocode, or specific steps in any sufficient detail to demonstrate that the inventor possessed the invention performing the claimed function of “wherein the at least on physiological characteristic includes a respiration characteristic indicated by tidal respiration volume, and determining the tidal respiration volume comprises analyzing changes in pixelation between a nose region and a mouth region of the target individual in infrared image data over time,” as there appears to be no disclosure of any specific algorithm for determining pixelation. Applicant has only described that the function can be done using image processing techniques, but not how applicant has achieved the function.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
U.S. Patent Application Publication No. 2020/0138292 to Choi et al. teaches determining respiration volume from imaging/thermal cameras via pixel-wise image processing, but does not go so far as to teach determining any pixelation of any ROI.
Korean Patent Document No. 102054213 to Shin et al. teaches determining tidal volume and changes in tidal volume from a thermal/infrared imaging camera using pixel-wise image processing techniques, but does not go so far as to teach determining any pixelation of any ROI.
U.S. Patent Application Publication No. 2022/0151541 to Patel teaches that in image processing, PHOSITA is motivated to correct pixelation in images as they are considered errors, rather than use pixelation data to determine physiological data.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 AMANDA L STEINBERG whose telephone number is (303)297-4783. The examiner can normally be reached Mon-Fri 8-4.
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/AMANDA L STEINBERG/ Examiner, Art Unit 3792
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