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 .
Applicant’s arguments, filed 6/16/2025 have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claims 53-58 are the current claims hereby under examination.
Claim Rejections - 35 USC § 103-Maitained
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 53-58 are rejected under 35 U.S.C. 103 as being unpatentable over “Clinical Guidelines: Pupillometer in Critical Neuro Patients, Use of” (hereinafter “St. Joseph Health”)(previously cited) in view of “NPi-200 Pupillometer Instructions for Use” (hereinafter “Neuroptics”)(previously cited).
Regarding claim 53, St. Joseph Health teaches a method of assessing a health condition of a mammalian subject comprising: using a pupilometer (page 3, section 3.b states equipment includes NPI 200 pupillometer system) to record images of a response of a left pupil of the subject to a stimulus thereby resulting in a first set of sequential images (page 1, VI. Purpose, “The pupillometer is a hand-held instrument which provides quantitative pupillary measurements by taking 30 pictures per second of the pupil's response to light stimulus.”; page 4, Measuring the Pupils with the NPI 200 pupillometer, “Press the button (LEFT) to start the scan of the left pupil.”) and displaying on a display of the pupilometer a pupillary index for the left pupil in connection with the first set of sequential images (page 4, Section 3.f.d. is measuring first pupil response to light stimulus; page 4, section 3.f.f state that both left and right measurements are displayed.); using the pupilometer to record images of a response of a right pupil of said subject to another stimulus (page 1, VI. Purpose, “The pupillometer is a hand-held instrument which provides quantitative pupillary measurements by taking 30 pictures per second of the pupil's response to light stimulus.”; page 4, Measuring the Pupils with the NPI 200 pupillometer, “Press the button (LEFT) to start the scan of the left pupil.”), thereby resulting in a second set of sequential images and displaying on the display of the pupilometer a pupillary index for the right pupil in connection with the second set of sequential images (page 4, Section 3.f.d. is measuring first pupil response to light stimulus; page 4, section 3.f.f state that both left and right measurements are displayed.).
St. Johns Health does not explicitly teach but does suggest, by using the NPI-200 pupilometer, displaying on the display of the pupilometer simultaneously the first set of images and the associated pupillary index for the left pupil and the second set of images and the associated pupillary index for the right pupil, wherein the two sets of images are synchronized, and wherein a center of the left pupil of each image from the first set of sequential images is aligned with a center of the right pupil from the second set of sequential images on the display; and displaying on the display a final patient outcome index representing a health condition of the patient, said final patient outcome index being based in part on the difference between the pupillary index of the left pupil and the pupillary index of the right pupil.
In particular, Neuroptics teaches displaying on the display of the pupilometer (NPI 200 Pupilometer ) simultaneously the first set of images and the associated pupillary index for the left pupil and the second set of images and the associated pupillary index for the right pupil, wherein the two sets of images are synchronized, and wherein a center of the left pupil of each image from the first set of sequential images is aligned with a center of the right pupil from the second set of sequential images on the display (page 5, Video Replay, “From the Results screen, select the Video icon to view the video playback of the reading (Ex. 21).”; This video replay, as shown in Ex. 21, shows the first set of images and the second set of images at the same time. The photos are synchronized and the center of the pupils are aligned by parallel lines that go horizontally across all images. It also displays a graph of the outcome below the video replay.); and displaying on the display a final patient outcome index representing a health condition of the patient, said final patient outcome index being based in part on the difference between the pupillary index of the left pupil and the pupillary index of the right pupil (page 5, Ex. 18-20 show the results being displayed. These include the NPi of both pupils as well as the difference between the Npi of the left and right eyes. The NPi is a representation of the health condition. Page 6 has a chart showing that an NPi of <3.0 is abnormal. A difference in Npi between the right and left pupils of greater than or equal to 0.7 is also abnormal. This related to increasing intraocular pressure).
Neuroptics is directed toward the capabilities and use of the NPI-200 pupilometer. St. Johns Health uses the NPI-200 pupilometer as a way to measure patient pupillary response. It would have been obvious to one of ordinary skill in the art that the pupilometer has display capabilities taught by Neuroptics. It would have been obvious to one of ordinary skill in the art to watch the video play back and display the chart. Doing so would show the NPi of the patient which would corelate to increased intraocular pressure. This could then be used for effective and efficient treatment.
Regarding claim 54, the combination teaches the method of claim 53, wherein the mammalian subject is a human (St. Johns Health, page 1, Target Population, “Patients at risk”; Neuroptics, page 1, Indications for use, “measures pupil size and pupil reactivity in patients requiring neurological pupil examinations”).
Regarding claim 55, the combination teaches the method of claim 53, wherein the display generates a pair of parallel lines that extend form a perimeter of the left pupil to a perimeter of the right pupil in each image (Neuroptics, Page 5, Video Replay, Example 21 shows a pair of parallel lines that extend from a perimeter of one pupil to a perimeter of the next image.), the parallel lines having a first section (Neuroptics, Page 5, Example 21, from the top green line to the bottom green line is the first section. This is designated by two small vertical green lines) and a second section (Neuroptics, Page 5, Example 21, from the top yellow line to the bottom yellow line is the first section. This is designated by two small vertical yellow lines), wherein in the first section a distance between the parallel lines is defined by a diameter of the left pupil for each image and in the second section a distance between the parallel lines is defined by a diameter of the right pupil for each image (Neuroptics, Page 5, Example 21, These sections show pupillary diameter. There is a pupillary size chart below that shows the results of this measurement as well.).
Regarding claim 56, the combination teaches the method of claim 55, wherein a color of the parallel lines in the first section is different from a color of the parallel lines in the second section (Neuroptics, page 5, Example 21, The first section is in green and the second section is yellow).
Regarding claim 57, the combination teaches the method of claim 55, wherein anisocoria is detected by a difference between the sizes of the two pupils as demonstrated by a difference in the distances between the parallel lines in the first section and the parallel lines in the second section (page 5, Example 18-20, the difference between the pupil size is shown in the charts.).
Regarding claim 58, the combination teaches the method of claim 53, wherein the stimulus to the left eye and the stimulus to the right eye have the same attributes (St. Johns Health, page 4, section 3.f.d-3.f.e show doing the same procedure on the left and right pupils. The same procedure indicates the same light stimulus for both pupils).
Response to Arguments
Applicant’s arguments filed 6/16/205 regarding the 35 U.S.C 103 rejections have been fully considered, but they are not persuasive.
Applicant argues that St. Joseph Health in view of Neuroptics does not teach the limitation directed towards displaying a final patient outcome index. Applicant argues that claim 53 requires a whole new “final patient outcome index” that is not merely a difference between the NPi’s of the patient’s two eyes. Applicant argues this is taught in paragraph [0076] of the specification of the instant application. Applicant argues paragraph [0076] teaches the difference between NPI of the left and NPI of the right eye as one factor or element to determine the patient outcome index (POI), and the POI is an entirely different index as depicted in Figure 9.
Examiner respectfully disagrees with the argument that St. Joseph Health in view of Neuroptics does not teach the limitations of claim 1. Claim 1 simply states “displaying on the display a final patient outcome index representing a health condition of the patient, said final patient outcome index being based in part on a difference between the pupillary index of the left pupil and the pupillary index of the right pupil.”. Claim 1 does not state that the POI must be determined using other factors or elements. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. Therefore, applicant’s argument does not appear commensurate in scope with the claimed invention and as such not found persuasive.
Conclusion
No claim is allowed.
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 extension fee 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 Jason Sims, whose telephone number is (571)-272-7540.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, Jonathan Moffat can be reached via telephone (571)-272-4390.
Papers related to this application may be submitted to Technical Center 1600 by facsimile transmission. Papers should be faxed to Technical Center 1600 via the Central PTO Fax Center. The faxing of such papers must conform with the notices published in the Official Gazette, 1096 OG 30 (November 15, 1988), 1156 OG 61 (November 16, 1993), and 1157 OG 94 (December 28, 1993) (See 37 CFR § 1.6(d)). The Central PTO Fax Center number is (571)-273-8300.
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/JASON M SIMS/Supervisory Patent Examiner, Art Unit 3791