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 .
DETAILED ACTION
Status of the Application
Claim 1 is currently pending in this case and have been examined and addressed below. This communication is a Non-Final Rejection in response to the Claims filed on 10/29/2024.
Claim Objections
Claim 1 is objected to because of the following informalities: Claim 1 recites “NPI” and “TBI” which are abbreviations. The first occurrence of all acronyms or abbreviations should be written out for clarity, whether or not they may be considered well known. Appropriate correction is required.
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.
Claim 1 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.
Claim 1 recites the limitation "the left eye", “the right eye” in line 3; “the NPI” in line 3; “the patient” in line 10. There is insufficient antecedent basis for these limitations in the claim.
Claim Rejections - 35 USC § 103
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Siminou et al. (US 2019/0159671 A1), hereinafter Siminou, in view of McGetrick et al. (Molly E. McGetrick, Nathan Schneider, DaiWai M. Olson, Venkatesh Aiyagari, Darryl Miles; Automated Infrared Pupillometer Use in Assessing the Neurological Status in Pediatric Neurocritical Care Patients: Case Reports and Literature Review; 22 June 2021; J Child Sci 2021;11:e125–e132), hereinafter McGetrick.
As per Claim 1, Siminou discloses a method of assessing a health condition of a mammalian subject comprising:
using a pupilometer to take three or more sequential measurements over a period of time of the left eye and the right eye of the subject ([0025] pupillometer stimulates the eye and captures a rapid sequence of digital images and analyze to determine measurement of the diameter of the pupil, Abstract imaging left and right pupil to result in set of sequential images, i.e. over time; [0041] measurements are made for both the left and right eye ) and determining the NPI of each eye at each measurement ([0027] for each data sample/measurement calculating reaction variables), wherein the subject is hospitalized as a result of stroke, TBI, acute brain injury or other neurological impairment ([0005] monitoring for patients who have anisocoria from brain/head injury such as brain swelling, neurological conditions);
displaying on a display of the pupilometer a comparison between the NPI of the left and the NPI of right eye at each of the three or more sequential measurements ([0020] compare real-time response of left and right pupils to a stimulus, [0009] the measurements are recorded over a period of time at a particular number of sequential images per second, [0027] for example the measurements are taken over three seconds at 30 frames per second which is 90 total frames measured for each eye and the calculated variables are displayed, [0033] display results of the measurements of the pupils including a plot of the pupil response, [0042] comparison between left and right eyes and simultaneously display left and right pupil results, [0048] display left and right pupil images and measurements, [0054] display graphical representation of the pupillary response of left and right pupils).
However, Siminou may not explicitly disclose the following which is taught by McGetrick: determining whether the subject exhibits NPI differential persistence (page e131 col. 1 case 3 describes determining the NPi has persisted at a particular level); and
assessing the subject with having an increased risk of a bad neurological or health outcome if the patient exhibits NPI differential persistence (page e131 col. 1 case 3 describes determining the NPi has persisted at a particular level which results in assessing the patient with developing hydrocephalus which is a clinical worsening condition for the patient).
Therefore, it would have been obvious to a person of ordinary skill in the art prior to the filing date of the invention to combine the known concept of a patient with NPI differential persistence being indicative of an increased risk of a bad health outcome from McGetrick with the known method of measuring and displaying a person’s NPI over time from Siminou in order to provide an accurate and noninvasive neurological monitoring tool for physicians (McGetrick Page e125 Abstract).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Medberry (WO 2017/062777 A1) teaches assessing traumatic brain injury based on the pupil size measured on pupillometry of the right and left eye.
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/EVANGELINE BARR/Primary Examiner, Art Unit 3682