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 .
Claims 1-20 are hereby under examination.
Claim Rejections - 35 USC § 102
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 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.
Claims 1-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US20170367633A1 (Samadani, Uzma), hereto referred as Samadani.
As to claims 1, 8, and 15, Samadani teaches recording, by a camera, one or more videos of at least a portion of a subject's face; identifying one or more biomarkers associated with the subject within each of the one or more videos; measuring involuntary micromotions or fixational eye movements associated with the identified one or more biomarkers within each of the one or more videos([0332], “Video oculography is a relatively newer technique that use infrared cameras mounted in goggles to track the center of the pupil's position as the eye moves.”; the biomarker is interpreted as eye movement);
determining that a divergence exists with respect to a measurement associated with at least one of the one or more videos and a measurement associated with a dataset ([0058], “c) Comparing eye movement of at least one eye of the subject to a normal or mean eye movement…d) Calculating a standard deviation or p value for eye movement of at least one eye of the subject”); and
based, at least in part, on the divergence, providing a notification indicating that a brain injury is likely ([0063], “In some instances, the normal or mean eye movement of c) may be obtained from or observed in a subject suffering from a brain injury. The brain injury may be, for instance, a structural or a non-structural traumatic brain injury such as, for instance, a concussion, a subconcussion or a blast injury”).
As to claims 2, 9, and 16, Samadani teaches the one or more videos of at least a portion of the subject's face comprises at least a first video of at least a portion of one side of the subject's face and at least a second video of at least a portion of the opposite side of the subject's face (Fig. 8, [0240], “B. Represents eye movement tracking box plots 2 days after triage… C. Represent eye movement tracking box plots 13 days after triage.”; the examiner notes, left eye was recorded for video B and right eye was recorded for video C, meeting the recited limitation above.)
As to claims 3, 10, and 17, Samadani teaches the measurement associated with the at least one of the one or more videos is a measurement derived from the first video, and the measurement associated with the dataset is a measurement derived from the second video (Fig. 8, measurements are included on the right side of the box plots).
As to claims 4, 11, and 18, Samadani teaches determining that the divergence exists includes determining that a difference between the measurement associated with the at least one of the one or more videos and the measurement associated with the dataset exceeds a predetermined threshold ([0286], “According to the methods described, identifying the subject as having eye movement significantly different from the control, or identifying the subject as having eye movement of a first eye that is significantly different from eye movement of a second eye, may be performed using a z-score. Because 95% of all values in a normal distribution lie within two standard deviations of the mean, a z-score of 2 may be used as a significance threshold.”).
As to claims 5, 12, and 19, Samadani teaches the dataset comprises one or more biomarker measurements associated with a population group ([0235], “Thus in our subject population ranging in age from 7 to 75, there was no change in conjugacy of eye movements with age”).
As to claims 6, 13, and 20, Samadani teaches the dataset comprises historical measurements collected from the subject and collected prior to the brain injury (Fig. 2, Binocular tracking of a normal subject; Fig. 8, [0240], “B. Represents eye movement tracking box plots 2 days after triage… C. Represent eye movement tracking box plots 13 days after triage.”)
As to claims 7 and 14, Samadani teaches measuring the involuntary micromotions or fixational eye movements includes determining an amount of motion associated with the identified one or more biomarkers that is attributable to motion of the subject's head and taking the subject's head motion into account in determining the involuntary micromotions or fixational eye movements of the subject ([0279], “In some instances, the subject's head may be stabilized, such as, for instance by using a chinrest or similar stabilizing mechanism.”).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 8, and 15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, 8, 13, 15 and 19 of copending Application No. 18119159 in view of Samadani.
The copending application teaches recording, by a camera, one or more videos of at least a portion of a subject's face; identifying one or more biomarkers associated with the subject within each of the one or more videos; measuring involuntary micromotions or fixational eye movements associated with the identified one or more biomarkers within each of the one or more videos; determining that a divergence exists with respect to a measurement associated with at least one of the one or more videos (comparing the measured involuntary micromotions or fixational eye movements) and a measurement associated with a dataset (from claims 6, 13, and 19 of the copending application); and based, at least in part, on the divergence, providing a notification. However, the copending application teaches that the notification indicates that sedation is likely. Samadani teaches notification to brain injury ([0063], “In some instances, the normal or mean eye movement of c) may be obtained from or observed in a subject suffering from a brain injury. The brain injury may be, for instance, a structural or a non-structural traumatic brain injury such as, for instance, a concussion, a subconcussion or a blast injury”). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the copending application to include Samadani’s teaching of notifying brain injury because the methods used to detect sedation in the copending application can also be used to detect and notify brain injury, as taught by Samadani.
This is a provisional nonstatutory double patenting rejection.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELINA S JANG whose telephone number is (571)272-7019. The examiner can normally be reached M-F 9:00 am - 6:00 pm.
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/ELINA SOHYUN JANG/Examiner, Art Unit 3791
/JENNIFER ROBERTSON/Supervisory Patent Examiner, Art Unit 3791