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
1. This communication is a first office action, non-final rejection on the merits. Claims 1-12, as originally filed, are currently pending and have been considered below.
Priority
2. Applicant's claim for domestic priority under 35 U.S.C. 119(e) is acknowledged. The application is filed on 04/05/2012 but claims the benefit of US continuation 18336742 filed on 2023/06/16 (US 12303304 B2) and US continuation 17488673 filed on 2021/09/29 (US 11850079 B2).
Double Patenting
3. Claims 1-12 rejected on the ground of nonstatutory double patenting over claims 1-20 of U.S. Patent No. 12303304 B2 and claims 1-36 of U.S. Patent No. 11850079 B2 since the claims, if allowed, would improperly extend the “right to exclude” already granted in the patent.
4. 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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claim Rejections - 35 USC § 103
5. 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 of this title, 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.
6. The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) 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.
7. This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
8. Claims 1-3, and 6-8 are rejected under 35 U.S.C. 103(a) as being unpatentable over Yu (US 20180132744 A1) (hereinafter Yu) in view of Laribiere (US 5501230 A) (hereinafter Laribiere).
Regarding claim 1, Yu discloses a neurophysiology system (para 38, FIG. 1 physiological sign analysis system110 configured to extract, receive, obtain, analyze, or process the physiological information) comprising:
a patient module (para 39Fig. 2, FIG. 2, modules in the physiological sign analysis system. The system include one or more engines 200, one or more external devices 240, power supplies 250, cloud server 260, etc, engine 200 include acquisition module 210, an analysis module 220, and an output module 230, para 09, Artifact of electrodes activity: the artifact is often caused by a poor contact between human body and electrodes or disconnecting of human body to be measured and measuring system);
a controller electrically connected to the patient module and comprising a plurality of external interfaces, a memory, and one or more processors; and a display (para 38, FIG. 1, physiological sign analysis system, processor, a sensor, an embedded device based on single chip or Advanced RISC Machines (ARM), an analysis meter, a detector, etc. The transmission mode may be wired or wireless, The transmission device 130 include a central processor or a cloud server and physiological sign analysis system 110 acquire physiological information directly or indirectly, para 34, The system output and display condition of physiological information, para 43, output module 230 for outputting calculated, analyzed, determined, or processed physiological information and external device 240 refer to various devices that directly or indirectly connected to one or more modules of physiological sign analysis system 110 and external device 240 may be wired or wireless and external device 240 include a LED or LCD screen for displaying physiological information, or a storage device for storing physiological information).
Yu specifically fails to disclose one or more electrodes electrically connected to the patient module and configured to be connected to a patient.
In analogous art, Laribiere discloses one or more electrodes electrically connected to the patient module and configured to be connected to a patient (FIG. 1 shows an equivalent diagram of electrodes, col. 1, lines 9-11, device for processing biological signals sampled by electrodes on the skin of a patient,
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify teaching of systems may perform a calculation or an analysis on the acquired information by a plurality of algorithms, perform a determination or a processing on the calculation result, and output the determination result of the processed physiological information disclosed by Yu to process biological signals sampled by electrodes on the skin of a patient as taught by Laribiere to detecting the absence of the polarization current of input differential amplifier, so as to supply an alarm signal in the case of a detachment or disconnection of at least one electrode [Laribiere, Abstract].
Regarding claim 2, Yu discloses the neurophysiology system of claim 1, wherein the controller is a surgical technology platform for use in an operating room (para 33, physiological sign analysis system applied to a plurality of fields, including monitoring, medical diagnosis, motion monitoring, hospital health-care (including but not limited to critical patient monitoring, patient with genetic disease monitoring, patient in emergency case monitoring, etc.)).
Regarding claim 3, Yu discloses the neurophysiology system of claim 1, wherein the controller is configured to provide one or more surgical applications (para 33, system applied to medical diagnosis, motion monitoring, hospital health-care (including but not limited to critical patient monitoring, patient with genetic disease monitoring, patient in emergency case monitoring, etc.)).
Regarding claim 6, Yu discloses the neurophysiology system of claim 1, wherein the memory is configured to store information sufficient to implement a monitoring pipeline or a disconnect detection system (para 09, Artifact of electrode activity: the artifact is often caused by a poor contact between the human body and the electrode or the disconnecting of the human body, para 34, physiological information or the physiological data may be stored in a local or remote storage device, para 38, The acquisition device include device that implement functions of the devices).
Regarding claim 7, Yu discloses the neurophysiology system of claim 6, wherein to implement the disconnect detection system, the one or more processors are configured to: perform electromyography with the one or more electrodes (para 12, performing a noise determination on the remainder features; outputting a result of the noise determination); and
detect and remediate disconnection of a selected electrode of the one or more electrodes from a patient based on a comparison with noise (para 09, Artifact of electrode activity: the artifact is often caused by a poor contact between the human body and the electrode or the disconnecting of the human body, information suddenly changes, para 07, baseline drift is caused by poor contact of electrodes and impedance changes on the electrode-skin interface).
Regarding claim 8, Yu discloses the neurophysiology system of claim 6, wherein to implement the disconnect detection system, the one or more processors are configured to: obtain an electrode signal from a selected channel of the one or more channels (para 07, baseline drift is caused by poor contact of electrodes and impedance changes on the electrode-skin interface);
apply disconnect detection to the electrode signal; and use the electrode signal in neuromonitoring, wherein to apply disconnect detection to the electrode signal includes to process the electrode signal with machine learning framework trained to recognize noise (para 59, detection include an entropy calculation, a difference method, a band-pass filter method, a morphological algorithm, a length and energy transformation method, an artificial neural network, a genetic algorithm, sentence analysis, matched filtering method, para 20, analysis module for performing a noise determination on remainder features and output module for outputting result of noise determination).
9. Claims 4-5 are rejected under 35 U.S.C. 103(a) as being unpatentable over Yu (US 20180132744 A1) (hereinafter Yu) in view of Laribiere (US 5501230 A) (hereinafter Laribiere) and further in view of Shelton, IV (US 20220331047 A1) (hereinafter Shelton, IV).
Regarding claim 4, Yu and Laribiere fails to disclose the neurophysiology system of claim 3, wherein the one or more surgical applications comprise one or more of navigation, surgical planning, imaging, rod bending, or robot control.
In analogous art, Shelton, IV discloses the neurophysiology system of claim 3, wherein the one or more surgical applications comprise one or more of navigation, surgical planning, imaging, rod bending, or robot control (A robotic system 10 is used in the surgical procedure as a part of the surgical system 2. The robotic system 10 includes a surgeon's console 18, a patient side cart 20 (surgical robot), and a surgical robotic hub 22).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify teaching of systems may perform a calculation or an analysis on the acquired information by a plurality of algorithms, perform a determination or a processing on calculation result, and output determination result of the processed physiological information disclosed by Yu and Laribiere to use control module, display priority values to the surgical data, determining, by the control module, and presenting onto livestream visual representations of surgical data as taught by Shelton, IV to adjustments to resource-allocation controls, and adjusting power consumption of one or more of the different components based on user input through the resource-allocation controls [Shelton, IV, para 06].
Regarding claim 5, Yu and Laribiere fails to disclose the neurophysiology system of claim 3, wherein the controller comprises a portable unit movable within or between operating rooms and useable during an operation to interact with one or more of the surgical applications.
In analogous art, Shelton, IV discloses the neurophysiology system of claim 3, wherein the controller comprises a portable unit movable within or between operating rooms and useable during an operation to interact with one or more of the surgical applications (para 08, FIG. 1 is a block diagram of a computer-implemented interactive surgical system, para 05, method for presenting surgical data onto a livestream of a surgical field on a display during a surgical procedure).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify teaching of systems may perform a calculation or an analysis on the acquired information by a plurality of algorithms, perform a determination or a processing on calculation result, and output determination result of the processed physiological information disclosed by Yu and Laribiere to use control module, display priority values to the surgical data, determining, by the control module, and presenting onto livestream visual representations of surgical data as taught by Shelton, IV to use electrosurgical devices are configured to deliver therapeutic or nontherapeutic RF energy to tissue to elements of surgical staplers, electrosurgical, and ultrasonic devices used in combination in surgical instrument [Shelton, IV, para 236].
9. Claims 9-12 are rejected under 35 U.S.C. 103(a) as being unpatentable over Yu (US 20180132744 A1) (hereinafter Yu) in view of Laribiere (US 5501230 A) (hereinafter Laribiere) and further in view of NAKAE (US 20230229977 A1) (hereinafter NAKAE).
Regarding claim 9, Yu and Laribiere fails to disclose the neurophysiology system of claim 7, wherein the comparison with noise comprises comparing a power spectral density of the electrode signal with a power spectral density of a noise signal.
In analogous art, NAKAE discloses the neurophysiology system of claim 7, wherein the comparison with noise comprises comparing a power spectral density of the electrode signal with a power spectral density of a noise signal (para 127, potential correlations (frontal-vertex potential correlation (a correlation coefficient, a partial correlation coefficient, connectivity, causality and their subspecies)) or inter-electrode phase synchronization (coherence, a phaselocking value); frequency powers includes a spectral density, a power spectrum and their subspecies).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify teaching of systems may perform a calculation or an analysis on the acquired information by a plurality of algorithms, perform a determination or a processing on calculation result, and output determination result of the processed physiological information disclosed by Yu and Laribiere to estimates a subjective evaluation by the estimation subject on the basis of the feature data and the plurality of feature templates or the plurality of models as taught by NAKAE to amplitude distribution characteristic values such as a median amplitude, an amplitude mode, a large amplitude, a peak amplitude and a quartile amplitude; mutual relationships among wave features include potential correlations [NAKAE, para 127].
Regarding claim 10, Yu and Laribiere fails to disclose the neurophysiology system of claim 7, comprising determining a Pearson correlation coefficient.
In analogous art, NAKAE discloses the neurophysiology system of claim 7, comprising determining a Pearson correlation coefficient (para 127, potential correlations (frontal-vertex potential correlation (a correlation coefficient, a partial correlation coefficient, connectivity, causality and their subspecies)) or inter-electrode phase synchronization (coherence, a phaselocking value); frequency powers includes a spectral density, a power spectrum and their subspecies).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify teaching of systems may perform a calculation or an analysis on the acquired information by a plurality of algorithms, perform a determination or a processing on calculation result, and output determination result of the processed physiological information disclosed by Yu and Laribiere to estimates a subjective evaluation by the estimation subject on the basis of the feature data and the plurality of feature templates or the plurality of models as taught by NAKAE to includes estimation means which can use arbitrary a similarity degree in addition to the correlation coefficient to add index indicating a similarity degree encompasses [NAKAE, para 249].
Regarding claim 11, Yu discloses the neurophysiology system of claim 7, wherein the comparison with noise comprises determining a cosine similarity, Euclidean distance, Mahalanobis distance, mutual information, or Spearman's correlation.
In analogous art, NAKAE discloses the neurophysiology system of claim 7, wherein the comparison with noise comprises comparing a power spectral density of the electrode signal with a power spectral density of a noise signal (para 127, potential correlations (frontal-vertex potential correlation (a correlation coefficient, a partial correlation coefficient, connectivity, causality and their subspecies)) or inter-electrode phase synchronization (coherence, a phaselocking value); frequency powers includes a spectral density, a power spectrum and their subspecies).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify teaching of systems may perform a calculation or an analysis on the acquired information by a plurality of algorithms, perform a determination or a processing on calculation result, and output determination result of the processed physiological information disclosed by Yu and Laribiere to estimates a subjective evaluation by the estimation subject on the basis of the feature data and the plurality of feature templates or the plurality of models as taught by NAKAE to includes estimation means which can use arbitrary a similarity degree in addition to the correlation coefficient to add index indicating a similarity degree encompasses [NAKAE, para 249].
Regarding claim 12, Yu and Laribiere fails to discloses the neurophysiology system of claim 7, wherein the comparison with noise comprises comparing the electrode signal and the noise signal to generate an amount of linear correlation of the noise signal and the electrode signal;
determining if the amount of linear correlation satisfies a predetermined threshold; and
responsive to determining the amount of linear correlation satisfies the predetermined threshold, determining the electrode signal is disconnected from a patient and providing an alert that the electrode is disconnected from the patient.
In analogous art, NAKAE discloses the neurophysiology system of claim 7, wherein the comparison with noise comprises comparing the electrode signal and the noise signal to generate an amount of linear correlation of the noise signal and the electrode signal (para 115-116, As machine learning, linear regression, logistic regression, support vector machine or the like can be used, and the discrimination accuracy of each model can be calculated by performing cross-validation, perform machine learning (linear regression, logistic regression, support vector machine or the like) and cross-verification, the discrimination accuracy of each model can be calculated);
determining if the amount of linear correlation satisfies a predetermined threshold (para 115-116, As machine learning, linear regression, logistic regression, support vector machine or the like can be used, and the discrimination accuracy of each model can be calculated by performing cross-validation); and
responsive to determining the amount of linear correlation satisfies the predetermined threshold, determining the electrode signal is disconnected from a patient and providing an alert that the electrode is disconnected from the patient (para 116, machine learning can be used, and linear regression, logistic regression, support vector machine (SVM) or the like can be utilized as supervised machine learning, para 125, current generated by a potential difference accompanying the neural activity of the brain and measured using a pair of electrode placed, para 311, electrodes were attached to the middle and ring fingers of the left hand. Next, a “noise session” was started for the estimation target object).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify teaching of systems may perform a calculation or an analysis on the acquired information by a plurality of algorithms, perform a determination or a processing on calculation result, and output determination result of the processed physiological information disclosed by Yu and Laribiere to estimates a subjective evaluation by the estimation subject on the basis of the feature data and the plurality of feature templates or the plurality of models as taught by NAKAE to accurately predict the subjective assessment by the estimation target object without giving a load to the estimation target object in advance [NAKAE, para 251].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Mirza Alam whose telephone number is (469) 295-9286. The examiner can be reached on Monday-Thursday 7:30AM-6:00PM (EST).
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Steven Lim can be reached on 571-270-1210. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MIRZA F ALAM/Primary Examiner, Art Unit 2688
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