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 .
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(s) 1, 3-5, 7-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Johnson et al. (US 2012/0136276 A1 – cited by Applicant), hereinafter Johnson, further in view of Kranck (US 2020/0001401 A1 – cited by Applicant).
Regarding Claim 1, Johnson teaches: A method of automatically obtaining from a patient a combination of subcortical and cortical somatosensory evoked response potentials, EEG, and Brainstem auditory evoked responses during a surgical procedure using surface electrodes (abstract), the method implemented automatically by a computing device (paragraph 0004-0007; 0017), the method comprising:
providing at least one of electrical stimulation via a first electrode positioned over at least one peripheral nerve of at least one extremity of the patient (paragraph 0004-0007) and auditory stimulation via a second electrode positioned over or within a first ear of the patient (Examiner notes this limitation is not required)
recording via a third recording electrode associated with the second electrode over or within the first ear of the patient, the third electrode utilizing a fourth reference electrode (paragraph 0007);
detecting electrical responses from the brainstem and cortex (paragraph 0007-0008, 0032, 0037, 0044);
recording electrical waveforms produced both spontaneously and those resulting from the electrical stimulation (paragraph 0008);
averaging the electrical waveforms resulting from the electrical and/or auditory stimulation (paragraph 0047);
automatically detecting an initial state of the electrical responses (paragraph 0049; 0019);
further stimulating the first and/or second electrodes (paragraph 0032; repeatedly);
detecting a change in the resultant electrical waveforms during further recording over time (paragraph 0045);
analyzing the detected change in the resultant electrical waveforms over time to automatically identify injury or potential injury along associated neural pathways (paragraph 0045);
analyzing the detected change in the resultant electrical waveforms to automatically identify changes in anesthesia level over time (paragraph 0049);
integrating available information from the electrical waveforms to determine if the detected change in the electrical waveforms is due to anesthesia or potential injury or both (paragraph 0009; 0045);
forwarding data to a display, the data comprising information for displaying the waveforms or an anatomical diagram that depicts a location of the detected change (paragraph 0015; 0049; 0089).
Johnson fails to mention the use of ear electrodes and recording electrical waveforms produced both spontaneously and those resulting from the electrical and auditory stimulation.
Kranck teaches the use of ear electrodes and further teaches the use of electrical and auditory stimulation (paragraph 0002, 0014, 0034-0035, 0044). 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 ear electrodes and recording electrical waveforms produced both spontaneously and those resulting from the electrical and auditory stimulation to allow for a more comprehensive biometric measurement.
Regarding Claim 3, Johnson in view of Kranck teach: The method of claim 1, wherein the fourth reference electrode is placed over or inside a second ear of the patient Kranck – paragraph 0002, 0014-0015; 0034, 0035, 0044).
Regarding Claim 4, Johnson in view Kranck teach: The method of claim 1, wherein the surgical procedure is a spinal surgery (Johnson - paragraph 0032-0035).
Regarding Claim 5, Johnson in view of Kranck teach: The method of claim 1, wherein the auditory stimulation is periodic (Kranck - paragraph 0044-50).
Regarding Claim 7, Johnson in view of Kranck teach: The method of claim 1, wherein the resultant electrical waveforms are responses from either the brainstem or cerebrum, or both (Johnson - paragraph 0007-0008, 0032, 0037, 0044).
Regarding Claim 8, Johnson in view of Kranck teach: The method of claim 1, wherein automatically determining, if the resultant electrical waveforms are adequate for ongoing monitoring includes the results of further stimulation (Johnson - paragraph 0044-0049; 0091).
Regarding Claim 9, Johnson in view of Kranck teach: The method of claim 1, further comprising determining if the resultant electrical waveforms might be improved by a change in a stimulation frequency, intensity, or duration (Johnson - paragraph 0044-0049; 0091).
Regarding Claim 10, Johnson in view of Kranck teach: The method of claim 1, wherein integrating the combined available information from the electrical waveforms is performed by an algorithm or by an artificial intelligence classifier (Johnson - paragraph 0009, 0045-0049, 0065).
Regarding Claim 11, Johnson in view of Kranck teach: The method of claim 1, further comprising alerting a user to the detected change using at least one of:
a notification;
an alert;
a communication;
an indication; or
an alarm (Johnson - paragraph 0014-0015).
Regarding Claim 12, Johnson in view of Kranck teach: The method of claim 1, further comprising displaying information based on the resultant electrical waveforms on at least one display (Johnson - paragraph 0014-0015).
Regarding Claim 13, Johnson in view of Kranck teach: The method of claim 1, further comprising receiving a user input regarding an accuracy of the resultant electrical waveforms (Johnson - paragraph 0016).
Regarding Claim 14, Johnson in view of Kranck teach: The method of claim 1, wherein the further stimulating step is due to user intervention, a predetermined frequency or sequence, or in response to a detected change in the electrical signals (Johnson - paragraph 0091).
Claim(s) 2, 6, 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Johnson in view of Kranck further in view of Lee et al. (US 2007/0055169 A1 – cited by Applicant), hereinafter Lee.
Regarding Claim 2, Johnson in view of Kranck teach: The method of claim 1, but do not mention a configuration wherein the fourth reference electrode is placed on or near a patient's forehead.
Lee teaches the use of a reference electrode on or near a subject’s forehead (paragraph 0027). 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 wherein the fourth reference electrode is placed on or near a patient's forehead as it has been held that rearrangement of parts is a matter of routine skill in the art (MPEP 2144.04 VI C).
Regarding Claim 6, Johnson in view of Kranck teach: The method of claim 1, but do not mention wherein said recording electrode is coupled to at least one ear and one part of a patient's forehead.
Lee teaches wherein said recording electrode is coupled to at least one ear and one part of a patient's forehead (paragraph 0027). 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 wherein said recording electrode is coupled to at least one ear and one part of a patient's forehead as it has been held that rearrangement of parts is a matter of routine skill in the art (MPEP 2144.04 VI C).
Regarding Claim 15, Johnson teaches: A method of identifying neural dysfunction and anesthetic effect and forehead electrodes in a surgical patient (paragraph 0004-0009), the method comprising:
stimulating at least one of one or more peripheral nerves in one or more extremity (paragraph 0006);
recording resultant electrical waveforms generated by brainstem and cerebrum of the surgical patient in response to the stimulations using a recording electrode with a reference electrode over one or more areas of the forehead (paragraph 0004-0009);
recording spontaneous electrical waveforms from the cerebrum using a recording electrode with a reference electrode over one or more areas of the forehead (paragraph 0004-0009);
detecting, by a computing device, by various means, a change in the resultant electrical waveforms (paragraph 0009; 0045);
analyzing, by the computing device, by various means, the detected change in the resultant electrical waveforms to automatically identify the neural dysfunction, the neural dysfunction comprising an immediate or potential injury to one or more nerve structures due to stress associated with a surgical occurrence during a surgery (paragraph 0045);
analyzing, by the computing device, by various means, the detected change in the resultant electrical waveforms to automatically identify changes in anesthesia during a surgery (paragraph 0048);
analyzing, by the computing device, by various means, the detected change in the resultant electrical waveforms to automatically identify one or more effects of anesthesia on all of the resultant electrical waveforms (paragraph 0048);
and forwarding data to a display, the data comprising at least one of the electrical waveforms and an anatomical or functional diagram that depicts a location or degree of the detected change (paragraph 0015; 0049; 0089).
Johnson fails to mention the use of ear electrodes for sound stimulation.
Kranck teaches the use of ear electrodes and further teaches the use of electrical and auditory stimulation (paragraph 0002, 0014, 0034-0035, 0044). 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 ear electrodes for auditory stimulation to allow for a more comprehensive biometric measurement.
Johnson in view of Kranck do not mention a configuration wherein a reference electrode is placed on or near a patient's forehead or ear.
Lee teaches the use of a reference electrode on or near a subject’s forehead (paragraph 0027). 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 wherein the reference electrode is placed on or near a patient's forehead as it has been held that rearrangement of parts is a matter of routine skill in the art (MPEP 2144.04 VI C).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. John et al. US 6385486 B1 – EEG and Audio for Brain function scan.
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
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