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 .
Status of Claims
The amendment filed 8/20/26 is acknowledged. Claims 1-5 are pending. Claims 1-5 are amended.
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 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 1, 5, and 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Stein (US 20170300654 A1) in view of Sahashi (US 20070040889 A1), Causevic (WO 2007016149 A2), Massengill (US 20110205167 A1), and Nicholson (US 20150040685 A1), further in view of Jones et al. (US 2016/0143574 A1), hereinafter Jones, further in view of Biopac Product Sheet; EEG Electrode Cap; (https://web.archive.org/web/20160913233838/https://www.biopac.com/wp-content/uploads/EEG-CAPS.pdf; captured 9/13/2016, dated 12/14/2015), hereinafter Biopac.
Regarding claim 1, Stein teaches a method of assessing whether an activity participant should return to an activity following a traumatic head injury at an injury site (Paragraph 0003 and Paragraph 0192), the method comprising: at the injury site (Paragraph 0159, element 102 and Paragraph 0106), a technician placing an EEG cap (Fig. 1-2: Brainscope’s Ahead (element 300), ElMindA) from a portable (Paragraph 0009: telemedicine system can also be a portable configuration and Paragraph 0106: The standalone system can be portable or implemented as a stationary system) carrying pack containing the EEG cap, an EEG signal amplifier (Paragraph 0126), a camera (element 255 and Paragraph 0262), a microphone (element 265 and Paragraphs 0040, 0262), and a first communication device (element 200) comprising a computer and a transmitter (Paragraph 0144), on a the activity participant’s head;
at the injury site, collecting brain assessment data using the EEG cap, the EEG signal amplifier, the camera, and the microphone, and sending the brain assessment data to the computer (Paragraph 0038), the brain assessment data comprising brain wave data (Paragraph 0262), audio of the subject (Paragraphs 0040, 0262), and video of the head of the subject (Paragraph 0262);
at the injury site, processing the brain assessment data including the brain wave data using the first communication device at the first location to compile diagnostic data of the subject (element 210 and Paragraph 0162: [The processor circuitry] “can be configured to carry out one or more baseband processing functions”) comprising brain wave data (Paragraph 0262), audio of the subject (Paragraphs 0040, 0262), and video of the head of the subject (Paragraph 0262);
transmitting the diagnostic data from the injury site (Paragraph 0076) to a second communication device located at a remote location (Paragraph 0144), the second communication device (element 120, element 130) comprising a microphone and a display device for displaying the brain wave data, audio of the subject, video of the head of the subject (Paragraph 0153), and audio of the technician;
at the remote location, displaying the diagnostic data in real time on the second communication device (Paragraph 0144);
at the remote location, assessing brain injuries based on the diagnostic data displayed on the second communication device (Paragraph 0040),
and transmitting a recommendation from the remote location to the injury site (Paragraph 0192: “Exemplary embodiments herein are directed to systems of care predicated on telemedicine and physiological and neurological evaluation that may optimize the quality and process of care with initiation of early, safe, and appropriate diagnosis and therapy that may improve prognosis and prevent death” and Paragraph 0067: “As described herein, ambulance telemedicine systems for stroke, TBI, and other neurological conditions may address and diagnosis at the time of first response, transport to the appropriate medical facility (e.g., hospital), and allow for the preparation for rapid definitive intervention with the appropriate diagnosis, personnel, & equipment for treatment when the patient arrives at the emergency facility”).
Stein fails to teach of including audio of the technician, a carrying portable pack of an EEG system, based on an assessment, determining whether the activity participant should return to the activity; transmitting as to whether the activity participant should return to the activity; conducting a first communication between the remote location, the technician at the injury site, and the activity participant at the injury site, in which a first plurality of queries are posed to the activity participant while the activity participant is directly observed by the technician at the injury site; conducting a second communication between the remote location and the technician at the injury site, but excluding the activity participant, in which second plurality of queries are posed to the technician regarding direct observation of the activity participant by the technician at the injury site; and at the remote location, assessing brain injuries based on the diagnostic data displayed on the second communication device, responses to the first queries, and responses to the second queries.
Sahashi teaches including the audio of the technician (Paragraph 0217: “nurse call”). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Stein to incorporate the audio of the technician as taught by Sahashi, because it allows for private conversations to be held between a doctor/expert and a nurse or patient (Paragraph 0217).
Stein teaches the system can be portable (Paragraph 0009: telemedicine system can also be a portable configuration and Paragraph 0106: The standalone system can be portable or implemented as a stationary system). Stein fails to teach a carrying pack explicitly.
Causevic teaches a carrying portable pack of an EEG system (Paragraph 0035: “the kit includes instructions for using handheld device 205, and comes in a portable carrying case”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the portable configuration of Stein include an explicit carrying pack, such as a bag or briefcase, to encase the portable system taught by Causevic, because the packaging would make a portable system much easier to use for neurological triage of a patient (Paragraph 0035 of Causevic).
Massengill teaches based on an assessment, determining whether the activity participant should return to the activity; and transmitting as to whether the activity participant should return to the activity (Paragraph 0054: “This score is well below the player's Personal Baseline Profile range of 6 to 9, and it is well below the Class Baseline Profile range of 5.75 to 8.75. The player should probably be removed from competition until further testing or treatment can be provided. If the athlete scores a sufficiently high performance level to indicate that no brain injury has occurred, he can be cleared to return to the game”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Stein include an explicit determination as to whether the participant can return to an activity taught by Massengill, because it would allow the participant to quickly return to the game if no injury is obtained (Paragraph 0009 of Massengill).
Nicholson teaches conducting a first communication between the remote location, the technician at the injury site, and the activity participant at the injury site, in which a first plurality of queries are posed to the activity participant while the activity participant is directly observed by the technician at the injury site (Paragraph 0063: “One such test is a thirty-question field-side test which has two sets of questions and other inquiries … the other set of inquiries are directed to the athlete's ability to provide accurate responses”);
conducting a second communication between the remote location and the technician at the injury site, but excluding the activity participant, in which second plurality of queries are posed to the technician regarding direct observation of the activity participant by the technician at the injury site (Paragraph 0063: “One such test is a thirty-question field-side test which has two sets of questions and other inquiries. One set of inquiries is incident-related, reviewing what happened to the athlete as viewed by an observer”: observation review inquiries would exclude the activity participant); and
at the remote location, assessing brain injuries based on the diagnostic data displayed on the second communication device, responses to the first queries, and responses to the second queries (Paragraph 0063: “After the user has completed the play-side concussion symptom detection test with the athlete, the test data is relayed to the Head Case central server where it can be paired with corresponding impact data that is collected from the sensor. The central server can pair the impact data that has a date and time that is close to the time frame in which the test was performed”). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Stein include the two separate queries taught by Nicholson, because it would allow the technician/observer to be able to provide explicit observation results to add to and improve the brain injury assessment (Paragraph 0063 of Nicholson).
Stein in view of Sahashi, Causevic, Massengill, and Nicholson fail to mention relocating an athlete to a sideline adjacent to an activity field following an injury, and that the method all occurs within 15 minutes after the injury.
Jones teaches relocating an athlete to a sideline adjacent to an activity field following an injury prior to assessing a subject’s health (Paragraph 0099 - The player is assisted off the field and placed on the sidelines). It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the method to include relocating an athlete to a sideline adjacent to an activity field following an injury in order to allow play to continue, and to increase player safety and privacy.
Jones also mentions that the assessment can take place within a period of approximately 30 minutes from the time of injury (Paragraph 0099 - within a period of approximately 30 minutes after a suspected concussion). It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the method to include that the method all occurs within 15 minutes after the injury as it has been held that "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) MPEP 2144.05 (II) and that a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close (MPEP 2144.05(I)).
Stein in view of Sahashi, Causevic, Massengill, Nicholson and Jones fail to mention the use of 10/20 placement wherein the EEG cap includes a plurality of electrodes connected to the EEG signal amplifier by 19 leads. Biopac teaches the use of 10/20 placement wherein the EEG cap includes a plurality of electrodes connected to the EEG signal amplifier by 19 leads(pages 1-2). It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the method to include the use of 10/20 placement wherein the EEG cap includes a plurality of electrodes connected to the EEG signal amplifier by 19 leads as the substitution of one portable EEG cap for another would have yielded predictable results to one of ordinary skill.
Regarding claim 2, Stein in view of Sahashi, Causevic, Massengill, Nicholson, Jones and Biopac teach the method of claim 1. Stein teaches a method wherein the instructions operation of assessing brain injuries further comprises steps of:
a. from the remote location, asking the activity participant at the injury site a series of questions (Paragraph 0259); and
b. from the sideline, performing a diagnostic test on the activity participant under
instruction from the physician at the remote location (Paragraph 0192).
Regarding claim 3, Stein in view of Sahashi, Causevic, Massengill, Nicholson, Jones and Biopac teach the method of claim 2. Stein fails to teach a method further comprising the operation of: selectively switching transmission of communications from the remote location between a first mode, in which communication is transmitted to both the technician and the activity participant, and a second mode, in which communication is transmitted to the technician but not the activity participant.
Sahashi teaches a method further comprising the operation of: selectively switching transmission of communications from the remote location (Paragraph 0006: “a person living in a remote place in which a doctor may not be available”) between a first mode, in which communication is transmitted to both the technician and the subject (Paragraph 0204: Nursing Room and Paragraph 206: “video and audio between the patient and the doctor”), and a second mode, in which communication is transmitted to the technician but not the activity participant (Paragraph 0217: “nurse call”). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Stein to incorporate an ability for a doctor to switch communication between subject and technician as taught by Sahashi, because it allows for private conversations to be held between a doctor/expert and a nurse or patient (Paragraph 0217).
Regarding claim 4, Stein in view of Sahashi, Causevic, Massengill, Nicholson, Jones and Biopac teach the method of claim 3. Stein fails to teach a method wherein communication selected to be delivered to the technician through the second mode are delivered through an earpiece worn by the technician.
Sahashi teaches a method wherein communication selected to be delivered to the technician through the second mode are delivered through an earpiece worn by the technician (Paragraph 0144). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Stein to incorporate a headset for the technician as taught by Sahashi, because it allows for private conversations to be held between a doctor/expert and a nurse or patient (Paragraph 0217).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Stein in view of Sahashi, Causevic, Massengill, Nicholson, Jones and Biopac further in view of Alvi (US 9788907 B1).
Regarding claim 5, Stein in view of Sahashi, Causevic, Massengill, Nicholson, Jones and Biopac teach the method of claim 3, but fail to teach a method wherein communication selected to be delivered to the technician through the second mode are delivered visually on a screen provided by the first communication device that is configured to be seen by the technician.
Alvi teaches a method wherein communication selected to be delivered to the technician through the second mode are delivered visually on a screen provided by the first communication device that is configured to be seen by the technician (Figure 6A, 6B, 6C and Paragraph 0083). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method to incorporate the instructions being given via the screen only to be seen by the technician taught by Alvi, because Alvi allows the doctor to “present useful procedural information” to the technician to improve patient care (Paragraph 0086).
Response to Arguments
Applicant’s amendments have been fully considered. The previous rejections are withdrawn.
A new rejection with newly found prior art is presented.
Conclusion
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 JAY B SHAH whose telephone number is (571)272-0686. The examiner can normally be reached M-F 8-5.
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JAY SHAH
Primary Examiner
Art Unit 3791
/JAY B SHAH/Primary Examiner, Art Unit 3791
