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
Pro Se Status
It appears the inventor(s) filed the current application pro se (i.e., without the benefit of representation by a registered patent practitioner). While inventors named as applicants in a patent application may prosecute the application pro se, lack of familiarity with patent examination practice and procedure may result in missed opportunities in obtaining optimal protection for the invention disclosed. The inventor(s) may wish to secure the services of a registered patent practitioner to prosecute the application, because the value of a patent is largely dependent upon skilled preparation and prosecution. The Office cannot aid in selecting a patent practitioner.
A listing of registered patent practitioners is available at https://oedci.uspto.gov/OEDCI/. Applicants may also obtain a list of registered patent practitioners located in their area by writing to Mail Stop OED, Director of the U.S. Patent and Trademark Office, P.O. Box 1450, Alexandria, VA 22313-1450.
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.
Subject Matter Eligibility
Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more, based on the following analysis:
Step 1: Are the claims directed to a statutory category of a process, machine, manufacture or composition of matter?
Yes, the claims are directed to a process.
Step 2A, Prong 1: Does the claim recite an abstract idea, law of nature or natural phenomenon?
Yes. As claimed, claim 1 is directed to mathematical concepts where it recites:
Extracting features from the collected ECG data using at least one feature extraction method; and
Classifying the features using supervised learning using a machine learning algorithm.
Similarly, claim 13 recites the same two limitations by reciting:
Extracting features from the collected ECG data using at least one feature extraction method; wherein the at least one feature extraction method is selected from the group consisting of: autoregressive coefficient (AR), Shannon entropy, fractal measure, and multiscale wavelet variance estimation; and
Classifying the features using supervised learning using a machine learning algorithm, wherein the machine learning algorithm is SVM.
Dependent claims simply add additional mathematical concepts, such as noise attenuation and calibration (see claim 2, also found in claim 13) with specifics of those steps in claims 3 and 14, the same feature extraction methods found in claim 13 are also found in claims 7-8, and the specific use of SVM as found in claim 13 is also found in claim 9. Additionally, claims 12 and 20 simply add that the classifying relies on a predetermined set of words.
Step 2A, Prong 2: Does the claim recite additional elements that integrate the judicial exception into a practical application?
No. The following are additional elements in claims 1 and 13:
Placing at least one electrode on an individual’
Collecting ECG data from the individual using the at least one electrode.
These steps relate to the pre-solution activity of data gathering. In other words, these are necessary steps required to perform the judicial exception itself, since you cannot perform the limitations recited in Step 2A, Prong 1 without having acquired data.
Dependent claims 4-6 and 15-17 are all part of this same pre-solution activity of data gathering, as they each provide additional detail of, for example, electrode placement, number of electrodes, and the use of visual or audio prompting.
Dependent claims 10-11 and 18-19 merely recite the demographic of people to which the method is intended to be performed, but does not change the judicial exception.
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception?
No. The following are additional elements in claims 1 and 13:
Placing at least one electrode on an individual’
Collecting ECG data from the individual using the at least one electrode.
These steps relate to the pre-solution activity of data gathering. In other words, these are necessary steps required to perform the judicial exception itself, since you cannot perform the limitations recited in Step 2A, Prong 1 without having acquired data.
Dependent claims 4-6 and 15-17 are all part of this same pre-solution activity of data gathering, as they each provide additional detail of, for example, electrode placement, number of electrodes, and the use of visual or audio prompting.
Dependent claims 10-11 and 18-19 merely recite the demographic of people to which the method is intended to be performed, but does not change the judicial exception.
Based on the analysis above, claims 1-20 are rejected under 35 U.S.C. 101 for lacking subject matter eligibility.
Utility
Claims 45-88 are rejected under 35 U.S.C. 101 because the claimed invention is not supported by either a credible asserted utility or a well-established utility.
MPEP 2107.01(II) states the following:
“II. WHOLLY INOPERATIVE INVENTIONS; "INCREDIBLE" UTILITY
An invention that is "inoperative" (i.e., it does not operate to produce the results claimed by the patent applicant) is not a "useful" invention in the meaning of the patent law. See, e.g., Newmanv.Quigg, 877 F.2d 1575, 1581, 11 USPQ2d 1340, 1345 (Fed. Cir. 1989); In re Harwood, 390 F.2d 985, 989, 156 USPQ 673, 676 (CCPA 1968) ("An inoperative invention, of course, does not satisfy the requirement of 35 U.S.C. 101 that an invention be useful."). However, as the Federal Circuit has stated, "[t]o violate [35 U.S.C.] 101 the claimed device must be totally incapable of achieving a useful result." Brooktree Corp.v.Advanced Micro Devices, Inc., 977 F.2d 1555, 1571, 24 USPQ2d 1401, 1412 (Fed. Cir. 1992) (emphasis added). See also E.I. du Pont De Nemours and Co.v.Berkley and Co., 620 F.2d 1247, 1260 n.17, 205 USPQ 1, 10 n.17 (8th Cir. 1980) ("A small degree of utility is sufficient . . . The claimed invention must only be capable of performing some beneficial function . . . An invention does not lack utility merely because the particular embodiment disclosed in the patent lacks perfection or performs crudely . . . A commercially successful product is not required . . . Nor is it essential that the invention accomplish all its intended functions . . . or operate under all conditions . . . partial success being sufficient to demonstrate patentable utility . . . In short, the defense of non-utility cannot be sustained without proof of total incapacity." If an invention is only partially successful in achieving a useful result, a rejection of the claimed invention as a whole based on a lack of utility is not appropriate. See In re Brana, 51 F.3d 1560, 34 USPQ2d 1436 (Fed. Cir. 1995); In re Gardner, 475 F.2d 1389, 177 USPQ 396 (CCPA), reh’g denied, 480 F.2d 879 (CCPA 1973); In re Marzocchi, 439 F.2d 220, 169 USPQ 367 (CCPA 1971).
Situations where an invention is found to be "inoperative" and therefore lacking in utility are rare, and rejections maintained solely on this ground by a federal court even rarer. In many of these cases, the utility asserted by the applicant was thought to be "incredible in the light of the knowledge of the art, or factually misleading" when initially considered by the Office. In re Citron, 325 F.2d 248, 253, 139 USPQ 516, 520 (CCPA 1963). Other cases suggest that on initial evaluation, the Office considered the asserted utility to be inconsistent with known scientific principles or "speculative at best" as to whether attributes of the invention necessary to impart the asserted utility were actually present in the invention. In re Sichert, 566 F.2d 1154, 196 USPQ 209 (CCPA 1977). However cast, the underlying finding by the court in these cases was that, based on the factual record of the case, it was clear that the invention could not and did not work as the inventor claimed it did. Indeed, the use of many labels to describe a single problem (e.g., a false assertion regarding utility) has led to some of the confusion that exists today with regard to a rejection based on the "utility" requirement. Examples of such cases include: an invention asserted to change the taste of food using a magnetic field (Fregeauv.Mossinghoff, 776 F.2d 1034, 227 USPQ 848 (Fed. Cir. 1985)), a perpetual motion machine (Newmanv.Quigg, 877 F.2d 1575, 11 USPQ2d 1340 (Fed. Cir. 1989)), a flying machine operating on "flapping or flutter function" (In re Houghton, 433 F.2d 820, 167 USPQ 687 (CCPA 1970)), a "cold fusion" process for producing energy (In re Swartz, 232 F.3d 862, 56 USPQ2d 1703 (Fed. Cir. 2000)), a method for increasing the energy output of fossil fuels upon combustion through exposure to a magnetic field (In re Ruskin, 354 F.2d 395, 148 USPQ 221 (CCPA 1966)), uncharacterized compositions for curing a wide array of cancers (In re Citron, 325 F.2d 248, 139 USPQ 516 (CCPA 1963)), and a method of controlling the aging process (In re Eltgroth, 419 F.2d 918, 164 USPQ 221 (CCPA 1970)). These examples are fact specific and should not be applied as a per se rule. Thus, in view of the rare nature of such cases, Office personnel should not label an asserted utility "incredible," "speculative" or otherwise unless it is clear that a rejection based on "lack of utility" is proper.”
35 USC 101 and 35 USC 112 (a) require an invention to possess specific and credible utility (MPEP 2107 (II)(B)(1)(ii). In this instance, the Applicant has asserted a utility that is inconsistent with known scientific principles or is ‘speculative at best’ as to whether attributes of the invention necessary to impart the asserted utility were actually present in the invention.” MPEP 2171.01 (II).
In the instant case, the application asserts that internalized speech (i.e., inner thoughts) may be recognized by electrical activity of the heart. However, internal speech is present with the brain, and does not transfer via electrical impulse to the heart. The heart is part of the autonomic nervous system (ANS), which regulates the heart rate and strength of contraction based on the needs of the human body. However, the heart beats independently of the brain, due to its intrinsic electrical system, which includes the sinoatrial node. There is no scientific evidence that voluntary thoughts effect the heart, where “voluntary thoughts” means, for example, making regular everyday decisions irrespective of an emotional response to that decision.
Claim Rejections - 35 USC § 112
First Paragraph
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
According to MPEP 23164.01(a), “There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is "undue." These factors include, but are not limited to:
(A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
(A) The breadth of the claims
The claims (see claims 1-20) present methods for recognition of “internalized speech”. According to paragraph 29 of the specification, “as used herein, ‘internalized speech’ means an individual’s thoughts or emotions that are not expressed audibly. For example, internalized speech can include, but is not limited to, an individual’s thoughts.” In paragraph 47 of the specification, it states that “Applicants performed feature extraction in the time domain to illuminate any risk of missing the dynamic changes in ECG due to the emotional status during inner speech activity.” Therefore, the disclosure appears to take active steps to avoid having emotion effect the recognition of the “internalized speech”, and therefore this term as it is defined in paragraph 29 appears to mean and be limited to the only example of “an individual’s thoughts”.
(B) The nature of the invention
The invention relates to a method “using a unimodal signal” (see line 1 of claim 1, for example), for which said unimodal signal is electrocardiography (ECG) (e.g., “collecting ECG data from the individual” and “extracting features from the elected ECG data” – see lines 4 and 6 of claim 1, for example) for the recognition of internalized speech (i.e., “an individual’s thoughts”).
In paragraph 3 of the specification, it states that “a unimodal approach” is one that uses a single type of signal. In other words, only ECG signals are being used within this process.
(C) The state of the prior art
The use of biological signals as inputs to computers is a growing field. Within the Cooperative Patent Classification (CPC) system, these types of applications for patent would be allocated the subgroup G06F 3/015, which is titled “Input arrangements based on nervous system activity detection, e.g. brain waves [EEG] detection, electromyograms [EMG] detection, electrodermal response detection”, where this input is ”for transferring data to be processed into a form capable of being handled by the computer” (see Title of CPC Main Group G06F 3/00). There currently are nearly 5,000 US patent documents that have this CPC subgroup (i.e., G06F 3/015) allocated to it, and just over 20,000 patent documents world-wide with this CPC subgroup allocated to it. However, this does not mean that each of these utilize ECG as type of detected signal. In fact, the title of this subgroup states “based on nervous system activity detection”, while the example types of detection are EEG, EMG and electrical response of the skin. While the use of these types of sensors is well-known, the use of ECG singularly as the input is not known.
In paragraph 3 of the specification, it states that “No study, however, has been published wherein there was an attempt to study or classify inner speech, imagined speech, or human thinking in general based on ECG alone in a unimodal approach (i.e., using a single type of signal).” As such, the application’s specification admits that there are no known publications related to the use of ECG as the sole input “to study or classify inner speech, imagined speech, or human thinking”.
While it is stated in paragraph 3 of the specification of the application that the amplitude of ECG signals, or the electrical signals of the heart, are “60 times higher [amplitude] than the electrical field generated by our brain”, the state of the art in ECG and the knowledge of what an ECG signal is, does not lend itself to being modified by a human based on their thoughts, such that it correlates to the thoughts within the brain. In other words, an ECG signal represents the electrical impulse propagating through the heart muscle to cause contraction of the heart muscle for the sole purpose of pumping oxygenated blood through the blood vessels of the human body. This is part of the autonomic nervous system (ANS), which functions involuntarily for the heart, as well as the gastrointestinal tract and the lungs. However, unlike the lungs where a person can actively hold their breath, a person cannot pause their heartbeat, nor can a person think a response to a question and actively modulate their heartbeat to give an answer. As such, the state of the prior art with respect to ECG illustrates that it is useful in diagnosing aberrations of the heart muscle itself, or at most to determine certain emotional states (e.g., increased heart rate may indicate stress).
Finally, the use of ECG electrodes on the head a person is atypical. Ordinary placement of a 12-lead ECG would provide electrodes at locations on the torso and shoulders. However, dependent claims and the disclosed invention require placement of “ECG electrodes” on the head. Additionally, paragraph 32 of the specification states that “Since the entire ECG frequency range covers or overlaps all possible EEG frequency bands, it is possible that one may not distinguish whether the raw signal being recorded is an ECG or an EEG signal. For example, a 10-Hz alpha signal cannot be distinguished from a 10-Hz ECG signal since they have the same instantaneous frequency.” Based on this statement, ECG electrodes placed on the head will inherently acquire electrical activity of the brain, in which case it leads one to question whether these are ECG signals or EEG signals. And again, it is known to use EEG signals as input to a computer and for detecting a person’s intentions (i.e., inner thoughts), but it is not known to use ECG signals for such.
(D) The level of one of ordinary skill
As stated above with respect to paragraph 3 of the specification, “No study, however, has been published wherein there was an attempt to study or classify inner speech, imagined speech, or human thinking in general based on ECG alone in a unimodal approach (i.e., using a single type of signal).”
Additionally, paragraph 3 also states “Research has revealed that the heart is the most potent source of the electrical field in the human body. The amplitude of the electrical field generated by the heart can be 60 times higher than the electrical field generated by our brain. In addition, they stated that the nervous system acts as an antenna that responds and tunes to the magnetic fields generated by the heart. More research to enhance this energetic communication ability can result in a much deeper level of non-verbal communication between people, such as inner speech.”
Also, paragraph 5 states “No studies have attempted to study or classify inner speech, imagined speech, or human thinking in general based on ECG.”
Therefore, the level of ordinary skill in the art is non-existent.
(E) The level of predictability in the art
With respect to the limiting amount of prior art available on the topics, there is a low level of predictability in the art.
Additionally, in paragraph 34 of the specification, the application states “Although, the accuracy achieved in this work indicates that most of the inner speech commands were distinguished between Drive, Stop, Right, and Left, the command Stop was incorrectly classified as Drive or Right. The other commands states were also incorrectly predicted. This misclassification is mainly due to the composite and subjective nature of emotions. Some researchers suggested that finding common features among different subjects’ heartbeats is difficult to be achieved.”
Therefore, there is a low level of predictability illustrated by the research that resulted in the instant application, for which this low level of predictability is stated within paragraph 34 of the specification.
(F) The amount of direction provided by the inventor
The specification of the instant application provides direction on placing ECG electrodes on a head of user (e.g., “the electrodes are placed on the left side of the individual’s forehead, the right side of the individual’s forehead, and on the individual’s left side anywhere below the neck” – see paragraph 10). Details are provided for a single experimental setup (see paragraphs 41-44), discussion of ECG preprocessing (see paragraphs 45-46), the use of autoregressive model coefficients, Shannon Entropy, fractal estimates and multiscale wavelet variance estimates for feature extraction (see paragraphs 47-55), the use of supervised learning to train a support vector machine model with 80% of the acquired data (see paragraphs 56-58). The application then discusses the results of this single experiment, for which the remaining 20% of the data was used to test the model (see paragraphs 59-65, and Table 1).
(G) The existence of working examples
The application does not present results of a working example of the claimed method. Instead, the application presents the findings of a single study in which a machine learning model was trained to recognize four internalized speech options (i.e., drive, stop, left or right), and the application admits in paragraph 34 that there is a low level of predictability.
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure
Based on the discussion in Factors (A)-(G) above, it is clear that there would be undue experimentation required to configure operating parameters of the claimed method to recognize internalized speech.
Based on the above description of Factors (A) – (H), claims 1-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES KISH whose telephone number is (571)272-5554. The examiner can normally be reached M-F 10:00a - 6p 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, Unsu Jung can be reached at (571) 272-8506. 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.
/JAMES KISH/ Primary Examiner, Art Unit 3792