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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 03 January 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. References that were lined through were lined through as no date was provided.
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2-17 are 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 2 recites a wearable device that comprises “a wearable device”. This renders the claim indefinite. For examination purposes, claim 2 is being interpreted such that the wearable device comprises “a carrier for housing the controller and video camera”. The same indefiniteness issue and interpretation also apply to claim 10. Claim 4 recites the phrase “the patient”. This phrase lacks proper antecedent basis. Claim 4 recites the phrase “the camera attached to the carrier”. This phrase lacks proper antecedent basis (an item housed in a carrier is not necessarily “attached” to the carrier). Claim 5 recites the phrase “cables connecting the EEG controller are affixed to the straps of the carrier”. The phrases “the EEG controller” and “the straps” both lack proper antecedent basis. Furthermore, “cables connecting the EEG controller” renders the claim indefinite in that it fails to disclose what the cables connect the EEG controller to. For examination purposes, the phrase is being interpreted as “cables connecting to the controller”, and “the straps” of the carrier are being interpreted as any connectable straps/arms of a carrier. Regarding claim 6, the term “rigid” in the phrase “rigid material” is a relative term. It is unclear what is to be considered a “rigid” material for the carrier. The phrase “to withstand the impact of the carrier” is also a relative term. What are the metes and bounds of the phrase “to withstand”? For examination purposes, any material will be considered to be a “rigid” material that can withstand the impact of the carrier or the user falling to the ground. Regarding claim 7, the phrase “the wearer” lacks proper antecedent basis. Regarding claim 9, (1) the term “easy” is a relative term which is not properly defined by either the specification or the claim, and (2) it is unclear what further structural limitation the claim imparts to the claimed invention. Furthermore, the phrase “the user” lacks proper antecedent basis. For examination purposes, any wearable device that is capable of being put on and removed by a user will be considered to read on the claim. Regarding claim 11, it is unclear what further limitation the claim provides; claim 11 merely recites an intended use of the video recorded by the video camera. Furthermore, the phrase “the patient” lacks proper antecedent basis. Regarding claim 13, the phrase “comfortable enough” is a relative phrase that renders the claim indefinite. It is unclear what is to be considered “comfortable enough”. Furthermore, the claim does not provide information on what the “is designed to” entails. What structural configurations lead to the system being “comfortable enough”? For examination purposes, any system designed to allow a user to wear the system for prolonged periods of time (e.g., hours or days) will be considered “designed to be comfortable enough that it can be worn for the majority of the full recording time including waking and sleeping hours”. Further regarding claim 13, the phrase “the full recording time” lacks proper antecedent basis. Regarding claim 14, it is unclear what further limitation the claim provides and what is to be considered a design that “poses minimal interference with the activity of daily living”. The phrase “minimal interference” itself is a relative term that renders the claim indefinite. For examination purposes, any system that is designed to be worn by a user for extended periods of time (e.g., hours or days) will be considered “designed to pose minimal interference”. Regarding claim 15, the phrase “the wide-angle view of the patient” lacks proper antecedent basis for use of the phrase “the wide-angle view” and “the patient”. For examination purposes, claim 15 is being interpreted such that any angle view of a patient assists clinicians in monitoring the patient’s physical state and a location of the patient in an environment. Further regarding claim 15, even with the interpretation provided by the Examiner, it is unclear what further limitation the claim provides as the claim is merely reciting the intended use of a view recorded by the video camera. The view captured by the video camera is capable of assisting clinicians in monitoring a patient’s physical state and a location of the patient in an environment; what further structural limitation to the claimed system does claim 15 provide? Regarding claim 17, the phrase “the remote monitoring of the camera” lacks proper antecedent basis. For examination purposes, the phrase is being interpreted as “remote monitoring of the camera”. Furthermore, it is unclear what further limitation is provided by claim 17. If a method allows a technician to monitor video data acquired by a remote video camera in real-time, it allows the technician to check a patient at any desired interval.
Claims not explicitly rejected above are rejected due to their dependence on a rejected base claim.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 16 and 17 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea. A streamlined analysis of claim 16 follows.
Regarding claim 16, the claim recites a series of steps or acts, including monitoring EEG and video camera data by technicians, doctors, and medical staff. Thus, the claim is directed to a process, which is one of the statutory categories of invention.
The claim is then analyzed to determine whether it is directed to any judicial exception. The step of monitoring EEG and video camera data by technicians, doctors, and medical staff sets forth a judicial exception. This step describes a concept performed in the human mind (including an observation, evaluation, judgment, opinion). Thus, the claim is drawn to a Mental Process, which is an Abstract Idea.
Next, the claim as a whole is analyzed to determine whether the claim recites additional elements that integrate the judicial exception into a practical application. The claim fails to recite an additional element or a combination of additional elements to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception. The monitoring of the data does not provide an improvement to the technological field, the method does not effect a particular treatment or effect a particular change based on the monitoring of data, nor does the method use a particular machine to perform the Abstract Idea.
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception. Besides the Abstract Idea, the claim recites additional steps of placing recording elements in a carrier, placing EEG sensors on the head of a user, and transmitting received data to a server. The placing and transmitting steps are each recited at a high level of generality such that they amount to insignificant presolution activity, e.g., mere data gathering steps necessary to perform the Abstract Idea. When recited at this high level of generality, there is no meaningful limitation, such as a particular or unconventional step that distinguishes them from well-understood, routine, and conventional data gathering and transmitting activity engaged in by medical professionals prior to Applicant's invention. Furthermore, it is well established that the mere physical or tangible nature of additional elements such as the obtaining and transmitting steps do not automatically confer eligibility on a claim directed to an abstract idea (see, e.g., Alice Corp. v. CLS Bank Int'l, 134 S.Ct. 2347, 2358-59 (2014)).
Consideration of the additional elements as a combination also adds no other meaningful limitations to the exception not already present when the elements are considered separately. Unlike the eligible claim in Diehr in which the elements limiting the exception are individually conventional, but taken together act in concert to improve a technical field, the claim here does not provide an improvement to the technical field. Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception. Thus, the claim as a whole does not amount to significantly more than the exception itself. The claim is therefore drawn to non-statutory subject matter.
The dependent claim also fails to add something more to the abstract independent claim as it fails to further limit the independent claim. Claim 17 merely recites that monitoring of a remote camera allows a technician to check a patient at present intervals. This step is in and of itself a mental concept. The placing, transmitting, and monitoring steps recited in the independent claim maintain a high level of generality even when considered in combination with the dependent claim.
Claim Rejections - 35 USC § 102
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 2, 3, and 5-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Puttilli et al.’523 (US Pub No. 2018/0263523).
Regarding claim 2, Figure 1 of Puttilli et al.’523 discloses a wearable biophysiological signal acquisition device 100 comprising: a controller for recording EEG data (controller 300, section [0085]); a video camera (video camera 500, sections [0079-0084]); and a wearable device or carrier for housing the controller and video camera (helmet 100 is a carrier that houses the controller and video camera).
Regarding claim 3, the camera is capable of being operated remotely by a monitoring technician (section [0081] states that the video camera is controllable via remote).
Regarding claim 5, cables connecting to the EEG controller are affixed to straps of the carrier (sections [0068] and [0077]).
Regarding claim 6, the carrier is made of a rigid material to withstand the impact of the carrier or user falling to the ground (sections [0035], [0063-0064]).
Regarding claim 7, the video camera also records audio (section [0084]).
Regarding claim 8, the device is adjustable to the body size of the wearer (sections [0022-0023]).
Regarding claim 9, the device is easy to put on and remove by a user.
Claim Rejections - 35 USC § 103
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.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Puttilli et al.’523, as applied to claim 2, in view of Rhoades et al.’793 (USPN 10,433,793).
Regarding claim 4, Puttilli et al.’523 discloses all of the elements of the current invention, as discussed in paragraph 8 above, except for explicitly stating that the video camera provides full visibility of the patient’s face and arms. Rhoades et al.’793 teaches a video-EEG monitoring system wherein the video analyzed along with EEG data includes full visibility of a patient’s face and their arms (see Figure 5, video image 506, and col. 11, lines 12-18). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have configured the video camera of Puttilli et al.’523 to capture full visibility of a patient’s face and arms, as it would merely be combining prior art elements according to known methods to yield predictable results. The modification to Puttilli et al.’523 would provide a more comprehensive view of physical manifestations of a medical episode that can be analyzed along with the EEG data.
Claims 10-15 are rejected under 35 U.S.C. 103 as being unpatentable over Puttilli et al.’523 in view of Leyde et al.’024 (US Pub No. 2007/0150024).
Regarding claim 10, Puttilli et al.’523 discloses a system comprising the wearable biophysiological signal acquisition device of claim 1 (see rejection in paragraph 8 above). Puttilli et al.’523 fails to disclose that the device communicatively connects to a server via a network. Leyde et al.’024 teaches allowing a medical device to communicatively connect to a server via a network in order to allow a clinician to remotely review and monitor a patient’s medical condition (sections [0069], [0121]). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Puttilli et al.’523 to communicatively connect to a server via a network, as Leyde et al.’024 teaches that this would allow information from the device to be remotely reviewed and monitored by a medical professional. Furthermore, it is noted that section [0032] of Puttilli et al.’523 teaches sending acquired video-EEG data to a physician. As modified by Leyde et al.’024, the data would be sent to a physician via communication with a server over a network.
Regarding claim 11, the video camera of Puttilli et al.’523 captures video of a patient, and the video is capable of capturing clinical signs and symptoms which would help in the localization of focal seizure onset and differential diagnosis.
Regarding claim 12, section [0032] of Puttilli et al.’523 discloses that data is transmitted in real-time to an experienced clinician. The data is capable of being used to diagnose seizures occurring in deep cerebral structures.
Regarding claim 13, the system is comfortable enough that it can be worn for the majority of a full recording time including waking and sleeping hours (sections [0026] and [0065] of Puttilli et al.’523).
Regarding claim 14, the system is designed to pose minimal interference with the activity of daily living.
Regarding claim 15, the video camera taught by Puttilli et al.’523 captures a wide-angle view of a patient that is capable of assisting clinicians in monitoring the patient’s physical state and the location of the patient in an environment.
Claims 16 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over aireeg (Nihon Koden – cited by Applicant) in view of Cunningham, III et al.’824 (US Pub No. 2015/0362824) further in view of Rhoades et al.’793.
Regarding claim 16, aireeg discloses a method for monitoring the status of brain injury in patients in real time (second page of the brochure, “Real-time EEG waveform access and data montaging, filtering and annotating aid in diagnosis and improve workflow”, and “Real-time monitoring with dual video, event button, and optional SpO2 sensors provide powerful clinical tools to evaluate a patient’s clinical status”), the method comprising: placing an EEG controller in a carrier worn on the shoulders and body of a user (seen in the figure on the first page of the brochure); placing EEG sensors on the head of the user (seen in the figure on the first page of the brochure); transmitting data received from the EEG sensors to a server (seen in the figure on the second page of the brochure); and monitoring of EEG data and video camera data by technicians, doctors, and medical staff (second page of brochure, “Real-time monitoring with dual video, event button, and optional SpO2 sensors provide powerful clinical tools to evaluate a patient’s clinical status”).
While aireeg discloses use of video data, it fails to provide details of how the video data is obtained Cunningham, III et al.’824 teaches that video data of a person can be obtained by placing a video camera in a carrier worn on the shoulders and body of the person (see Figures 7 and 13, and sections [0007], [0015], [0034], and [0040]). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the method of aireeg such that it includes placing a video camera in the carrier, as this would provide a portable means by which to acquire the video data of the user.
aireeg in view of Cunningham, III et al.’824 discloses all of the elements of the current invention, as discussed above, except for the video camera having a full view of the face and arms of the user. Rhoades et al.’793 teaches a video-EEG monitoring method wherein the video analyzed along with EEG data includes full visibility of a patient’s face and their arms (see Figure 5, video image 506, and col. 11, lines 12-18). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have configured the video camera of aireeg in view of Cunningham, III et al.’824 to capture full visibility of the user’s face and arms, as it would merely be combining prior art elements according to known methods to yield predictable results. The modification to aireeg in view of Cunningham, III et al.’824 would provide a more comprehensive view of physical manifestations of a medical episode that can be analyzed along with the EEG data.
Regarding claim 17, the method of aireeg in view of Cunningham, III et al.’824 further in view of Rhoades et al.’793 allows technicians to check the user at preset intervals (this is inherent).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Dracup et al.’167 (US Pub No. 2013/0060167) teaches transmitting acquired physiological data to a server (section [0041]). Russell et al.’984 (US Pub No. 2015/0370984) teaches placing a controller in a body-wearable shoulder bag (section [0026). Kadambi’341 (US Pub No. 2017/0354341) teaches a video-EEG monitoring system. Fontana et al.’199 (US Pub No. 2017/0318199) teaches means to affix a video camera to a carrier bag (sections [0049], [0051]). Lifelines Neuro (cited by Applicant) teaches a system and method readable on the currently claimed invention.
The Examiner would also like to note that claims 16 and 17 could be rejected under 35 U.S.C. 103 with the following combination of prior art references: Pittulli et al.’523 in view of Echauz et al.’604 (US Pub No. 2010/0168604: this references teaches placing an EEG controller in a bag worn on the body of a person) further in view of Cunningham, III et al.’824 (this reference would modify Pittulli et al.’523 to include its video camera in the carrier) further in view of Rhoades et al.’793 (this reference would modify Pittulli et al.’523 such that its video camera captures a full view of the user’s face and arms) further in view of Leyde et al.’024 (this reference would modify Pittulli et al.’523 such that data is transmitted to a server).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ETSUB D BERHANU whose telephone number is (571)270-5410. The examiner can normally be reached Mon-Fri 9:00am-5:30pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Robertson can be reached at (571) 272-5001. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ETSUB D BERHANU/Primary Examiner, Art Unit 3791