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 .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. FR2111859, filed on 11/09/2021.
Information Disclosure Statement
The information disclosure statement(s) filed 05/09/2024, 07/18/2024, and 12/20/2024 has/have been considered by the Examiner.
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 1-11 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter (abstract ideas) without significantly more.
The framework for establishing a prima facie case of lack of subject matter eligibility requires that the Examiner determine: (1) Does the claim fall within the four categories of patent eligible subject matter; (2a) prong 1: Does the claim recite an abstract idea, law of nature, or natural phenomenon and (2a) prong 2: Does the claim recite additional elements that integrate the judicial exception into a practical application; and (2b) Does the claim recite additional elements that amount of significantly more than the judicial exception.
Step 1):
Claims 1-10 recite a method, which satisfies the 4 statutory categories (process, machine, manufacture, or composition of matter) of patent-eligible subject matter.
Claims 11 recite a non-transitory computer readable medium, which satisfies the 4 statutory categories (process, machine, manufacture, or composition of matter) of patent-eligible subject matter.
Step 2a) Prong One:
Independent claim 1 recites:
A detection method for implemented by a device and comprising:
generating sensory stimulation signals to be applied to a user by a human-machine interface intended for the user, the sensory stimulation signals being periodic and adjustable in frequency;
detecting evoked potentials in physiological signal (EEG) signals of the user as respective reactions to the generating of the sensory stimulation signals; and
selecting frequencies of the sensory stimulation signals according to a reaction speed of the user to the sensory simulation signals.
Independent claim 11 recites:
A non-transitory computer readable medium comprising instruction stored thereon for implementing a method for detecting evoked potentials in a physiological signal of the user, when said instructions are executed by a processor of a processing circuit, wherein the method comprises:
generating sensory stimulation signals to be applied by a human machine interface intended for the user, the sensory stimulation signals being periodic and adjustable in frequency;
detecting the evoked potentials in the physiological signals of the user, in reaction to the generating of the sensory stimulation signals; and
selecting frequencies of the sensory stimulation signals according to a reaction speed of the user to the sensory simulation signals.
Independent claims 1 and 11 are all directed to MENTAL PROCESSES, where nothing in the claim elements precludes the steps from practically being performed in the human mind but for the recitation of generic computer parts or by a human using pen and paper. In the instant case, a person could mentally detect by simple observation and identification. A person could then select by mentally identifying and choosing.
Dependent claims 2-10 contain no additional elements that integrate the abstract ideas into practical application, or amount to significantly more than the abstract idea itself. Dependent claims 2-6 and 10 are all further directed to mental processes (i.e. detecting, adjusting, selecting, storing). Dependent claims 2-10 only further define the abstract ideas (mental processes) in determining first pacing rates and receiving first blood pressures, and do not amount to significantly more than the abstract idea itself. Accordingly, the dependent claims are also directed to non-statutory subject matter.
Step 2a) Prong Two:
This judicial exception is not integrated into a practical application because mere instruction to implement on a computer, or merely using a computer as a tool to perform the abstract idea, adding insignificant extra solution activity, and/or generally linking the use of the abstract idea to a technological environment or field of use is not considered integration into a practical application. The Court defines the phrase “integration into a practical application” to require an additional element or a combination of additional elements in the claim to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that it is more than a drafting effort designed to monopolize the exception.
This judicial exception is not integrated into a practical application because claims 1-11 do not disclose using the result of the mental process steps (i.e. receiving and determining), for prophylactic treatment of a particular medical condition under MPEP 2106.05(e). In the instant case, there is no specific treatment in the form of stimulation/pacing pulses, drug therapy, radiation therapy, or other forms of treatment that is ultimately used to treat a particular condition as a result of the mental process steps (i.e. detecting, selecting). There is no specific treatment delivered to treat a particular condition that is specified in the claims, but is only directed to abstract ideas (mental processes) as stated above, of which can be performed by a human but for the recitation of generic computers, or with pen and paper. Accordingly, claims 1-11 do not disclose using the result of the mental processes steps for prophylactic treatment of a particular medical condition under MPEP 2106.05(e).
This judicial exception is not integrated into a practical application because claims 1-11 do not provide improvements to the functioning of a computer or to any the technical field under MPEP 2106.05(a). Specifically, the claims recite generic computer elements (processor, generator, human-machine interface), but these elements have not been described with sufficient detail to constitute an improvement in the tech field, as such these features merely define the field of use for the current invention by generally linking mental processes to generic computer elements as a tool to execute the abstract ideas (mental processes). By failing to explain how these elements are different from conventional computer elements, it is reasonable that the broadest reasonable interpretation of the additional elements is just a conventional computer performing generic functions (e.g., data analysis). Conventional computer elements performing basic data analysis is directed to the components of a system amounting to merely field of use type limitations and/or extra solution activity to implement the abstract idea as identified above, and merely including instructions to implement abstract ideas on a computer does not integrate the judicial exception into practical application, see MPEP 2106.04(d) Integration of a Judicial Exception into a Practical Application.
Additional elements further include steps of “generating sensory stimulation signals…”, of which can be considered pre-solution activity as a data-gathering step by administering stimulation signals to obtain evoked potential data. As such, these additional elements are merely nominal or tangential additions to the claims as they do not impose any meaningful limits on the claim, see MPEP 2106.05(g) Insignificant Extra-Solution Activity.
Accordingly, dependent claims 2-10 do not recite additional elements which practically integrate the judicial exception(s) of the current invention.
Step 2b)
Step 2B in the analysis requires us to determine whether the claims do significantly more than
simply describe that abstract method. Mayo, 132 S. Ct. at 1297. We must examine the limitations of the
claims to determine whether the claims contain an "inventive concept" to "transform" the claimed
abstract idea into patent-eligible subject matter. Alice, 134 S. Ct. at 2357 (quoting Mayo, 132 S. Ct. at
1294, 1298). The transformation of an abstract idea into patent-eligible subject matter "requires 'more
than simply stat[ing] the [abstract idea] while adding the words 'apply it."' Id. (quoting Mayo, 132 S. Ct.
at 1294) (alterations in original). "A claim that recites an abstract idea must include 'additional features'
to ensure 'that the [claim] is more than a drafting effort designed to monopolize the [abstract idea].'" Id.
(quoting Mayo, 132 S. Ct. at 1297) (alterations in original). Those "additional features" must be more
than "well-understood, routine, conventional activity." Mayo, 132 S. Ct. at 1298.
The claims also do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements as stated above is/are recognized as generic computer interfaces and generic computers (or computer components), because the claims do not describe these features as having distinguishing element(s) over their generic counterparts, which are well-understood, routine and conventional activities previously known in the industry. As shown in the reference as taught by Epley (US 20040097839 A1), which teaches a similar detection system (abstract) comprising a human-machine interface (headgear in figure 1), further comprising an electronic signal generator (paragraph 0167) and processing device (computer, paragraph 0027).
Additionally, Willand (US 20190381310 A1) similarly teaches detection system (abstract) comprising a human-machine interface (probe 100), stimulus pulse generator (paragraph 0136) and processing device (CPU, paragraph 0130).
Thus, the present claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. When looked at individually and as a whole, the claim limitations are determined to be an abstract idea without significantly more, and thus claims 1-11 are not patent eligible under 35 USC § 101.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1 and 9-14 is/are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Hagedorn (US 20150051663 A1 – hereinafter Hagedorn).
Re. claim 1, Hagedorn teaches a detection method for implemented by a device (abstract – “The present method and system provides for the clinical application of neurostimulation and/or neuromodulation to a patient. The method and system includes receipt and acquisition of patient data…”) and comprising:
generating sensory stimulation signals to be applied to a user (figure 2 step 220; paragraph 0053 - “…step 220 is also carried out which comprises providing sensory stimulus to a person”) by a human-machine interface intended for the user (figure 1, EEG cap or helmet 100), the sensory stimulation signals being periodic (paragraph 0136 – “The display may additionally include graphical information plotting measured changes across time periods”) and adjustable in frequency (paragraph 0067 – “Due to the know dielectric properties of skull and scalp tissue the device permits a dose-response adjustment such that the user can adjust frequency and intensity”);
detecting evoked potentials in physiological signal (EEG) signals of the user as respective reactions to the generating of the sensory stimulation signals (figure 2, step 230 measures event-related potentials after providing sensory stimulation in step 220; paragraph 0055 – “Based on the electrical measurements, that is, EEG or ERP measurements, an abnormality in a region of the brain is determined in step 230”);
and selecting frequencies of the sensory stimulation signals according to a reaction speed of the user to the sensory simulation signals (paragraph 0067 – “Due to the know dielectric properties of skull and scalp tissue the device permits a dose-response adjustment such that the user can adjust frequency and intensity according to measured electrophysiology changes taken at the stimulation location or all scalp locations (e.g., EEG amplitude, EEG coherence, ERP amplitude and latency)…”).
Re. claim 9, Hagedorn further teaches implemented at different moments during a day (paragraph 0137 – “The display may additionally include graphical information plotting measured changes across time periods”) and comprising storing at least one frequency attributable to a respective sensory stimulation signal of the sensory stimulation signals, corresponding to a respective moment during that day (paragraph 0080 – “The server further provides for the storage of the data and retention of data information. In this embodiment, the server creates a postscript formatted file, such as a PDF file and the database is then updated to include storage of this information”).
Re. claim 10, Hagedorn further teaches implemented at different moments during a day, for the user (paragraph 0137 – “The display may additionally include graphical information plotting measured changes across time periods”), and comprising storing at least one frequency attributable to a respective sensory stimulation signal of the sensory stimulation signals intended for that user, corresponding to a respective moment during that day (paragraph 0080 – “The server further provides for the storage of the data and retention of data information. In this embodiment, the server creates a postscript formatted file, such as a PDF file and the database is then updated to include storage of this information”).
Re. claim 11, Hagedorn teaches a non-transitory computer readable medium comprising instructions stored thereon (paragraph 0048 – “…which is manually operated or controlled by pre-programmed instructions”) for implementing a method for detecting evoked potentials in a physiological signals of the user (abstract – “The present method and system provides for the clinical application of neurostimulation and/or neuromodulation to a patient. The method and system includes receipt and acquisition of patient data…”) when said instructions are executed by a processor of a processing circuit (processing devices, paragraph 0010), wherein the method comprises:
generating sensory stimulation signals to be applied to a user (figure 2 step 220; paragraph 0053 - “…step 220 is also carried out which comprises providing sensory stimulus to a person”) by a human-machine interface intended for the user (figure 1, EEG cap or helmet 100), the sensory stimulation signals being periodic (paragraph 0136 – “The display may additionally include graphical information plotting measured changes across time periods”) and adjustable in frequency (paragraph 0067 – “Due to the know dielectric properties of skull and scalp tissue the device permits a dose-response adjustment such that the user can adjust frequency and intensity”);
detecting the evoked potentials in the physiological signals of the user, in reaction to the generating of the sensory stimulation signals (figure 2, step 230 measures event-related potentials after providing sensory stimulation in step 220; paragraph 0055 – “Based on the electrical measurements, that is, EEG or ERP measurements, an abnormality in a region of the brain is determined in step 230”);
and selecting frequencies of the sensory stimulation signals according to a reaction speed of the user to the sensory simulation signals (paragraph 0067 – “Due to the know dielectric properties of skull and scalp tissue the device permits a dose-response adjustment such that the user can adjust frequency and intensity according to measured electrophysiology changes taken at the stimulation location or all scalp locations (e.g., EEG amplitude, EEG coherence, ERP amplitude and latency)…”).
Re. claim 12, Hagedorn teaches a device for detecting an evoked potential in a physiological signal from a user (paragraph 0007 – “An object of the disclosed technology is to utilize a brain-computer interface with electroencephalography and event-related potential (ERP) measures to localize brain injury and dysfunctional regions”) comprising:
a generator of sensory stimulation signals (figure 1, electrical stimulation device 150), the generator of sensory stimulation signals being connectable to a human-machine interface adapted for reproducing the sensory stimulation signals generated for the user (figure 1, EEG cap or helmet 100), the sensory stimulation signals being periodic and adjustable in frequency (paragraph 0067 – “Due to the know dielectric properties of skull and scalp tissue the device permits a dose-response adjustment such that the user can adjust frequency and intensity”);
and a frequency selector for the sensory stimulation signals according to the user's reaction speed to the sensory stimulation signals (paragraph 0015 – “The conducting of non-invasive measurement of electrical currents, as well as the non-invasive brain stimulation, may be carried out by way of a single device with a single manually-operated control”; paragraph 0067 – “Due to the know dielectric properties of skull and scalp tissue the device permits a dose-response adjustment such that the user can adjust frequency and intensity according to measured electrophysiology changes taken at the stimulation location or all scalp locations (e.g., EEG amplitude, EEG coherence, ERP amplitude and latency)…”).
Re. claim 13, Hagedorn further teaches wherein the detection device comprises at least: a processing circuit (processing devices, paragraph 0010) configured for generating the sensory stimulation signals (figure 2 step 220; paragraph 0053 - “…step 220 is also carried out which comprises providing sensory stimulus to a person”) and selecting at least one frequency (paragraph 0015 – “The conducting of non-invasive measurement of electrical currents, as well as the non-invasive brain stimulation, may be carried out by way of a single device with a single manually-operated control”; paragraph 0067 – “Due to the know dielectric properties of skull and scalp tissue the device permits a dose-response adjustment such that the user can adjust frequency and intensity according to measured electrophysiology changes taken at the stimulation location or all scalp locations (e.g., EEG amplitude, EEG coherence, ERP amplitude and latency)…”)., an output interface connected to the processing circuit and connectable to the human-machine interface intended for the user, and an input interface connected to the processing circuit, for receiving said physiological signal from the user (figure 1 shows the human-machine interface 100 connected with the electrical stimulation device0 and amplifier 152 via input and outputs).
PNG
media_image1.png
312
404
media_image1.png
Greyscale
Re. claim 14, Hagedorn further teaches wherein the processing circuit comprises a memory storing at least some identifiers of respective frequencies of the sensory stimulation signals, and information specific to a portion of said frequencies and according to which the frequencies of said portion are commonly attributable to the sensory stimulation signals (paragraph 0079 – “…a data collection computing device, such as a personal computer or other type of processing device…”; frequency adjustment in paragraph 0067).
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(s) 7-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hagedorn (US 20150051663 A1 – hereinafter Hagedorn) in view of Heyrend (US 6115631 A – hereinafter Heyrend).
Re. claim 7, Hagedorn teaches the claimed method of claim 1 as stated above, but does not explicitly teach the method implemented during a calibration phase of the device, the device being intended for the given user.
Heyrend teaches a similar evoked response detection system (abstract – “A method and apparatus for determining the probability of ruminating behavior in a person of known age, sex and use of medication, is provided by generating and measuring a visually evoked response to a certain auditory and visually displayed paradigms”), and further teaches the known technique of implementing a detection method during a calibration phase of the device, the device being intended for this given user (Column 7, lines 36-53: “Each patient was administered a series of evoked potential studies and a quantitative electroencephalogram…A channel-by-channel calibration was performed before and after each recording session”). 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 the method of Hagedorn, to incorporate the calibration phase as taught by Heyrend, since such modification would predictably result in acquisition of relevant user data.
Re. claim 8, the combined invention of Hagedorn and Heyrend further teaches the method implemented during use, by the user, of the device of this user (Hagedorn paragraph 0011 – “The disclosed technology further includes user input and feedback functionality within a clinic or operational settings, whereby user measurements are collected, compared to one or more data sets and adjustments are made to the stimulation output”).
Allowable Subject Matter
Claims 2-6 objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. The following is a statement of reasons for the indication of allowable subject matter: the prior art of record does not explicitly teach the detection method comprising steps of, for a particular sensory stimulation signal of the sensory stimulation signals, the frequency is selected when a reaction latency of the user, between a moment the signal is generated and a moment the evoked potential is detected, when such detection occurs, is below a threshold, as stated in claim 2. Dependent claims 3-6 are further rejected due to their dependencies to claim 2.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Geva (US 20140163328 A1) teaches a similar detection system (abstract – “A method of estimating the likelihood of brain concussion from neurophysiological data…”) which calculates latency differences outside a predetermined range (paragraph 0110).
Dyell (US 20160058287 A1) teaches a patient monitoring system (abstract - “An apparatus for real time monitoring of a patient is provided…”) which includes latency threshold criteria 22 (paragraph 0029).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anh-Khoa N. Dinh whose telephone number is (571)272-7041. The examiner can normally be reached Mon-Fri 7:00am-4:00pm 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, CARL LAYNO can be reached at 571-272-4949. 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.
/ANH-KHOA N DINH/Examiner, Art Unit 3796