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 .
Response to Amendment
The amendment filed 29 June 2026 has been entered. Claim(s) 1 and 3-11 remain pending in the application. Applicant’s amendments to the claims have overcome and each and every rejection under 35 U.S.C. 102/103 previously set forth in the Office Action mailed 01 April 2026.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: electroencephalogram measurement device in claim 1; action measurement device in claim 1; electroencephalogram determination device in claims 1 and 9; action analysis device in claim 1 and 10; “storage device” in claim 1 and 10-11; “electroencephalogram measurement section” in claim 10-11; “action measurement section” in claim 10-11; “electroencephalogram determination section” in claim 10-11.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
The limitations are interpreted as follows:
Electroencephalogram measurement device and electroencephalogram measurement section (see paragraph 0063) is interpreted as an electroencephalogram detection device and electroencephalogram processor configured to output electroencephalogram data on a wearer, where the detection device provides inputs to the processor (Paragraph 0106, device 122 and processor 212, Fig. 4).
Action measurement device or action measurement section (Paragraph 0061) is interpreted as a sensor, in-camera, out-camera, and sensor processor configured to output action data on the wearer, where the sensor, in-camera, and out-camera provide inputs to the sensor processor, or as a sensor and a processor (Paragraph 0061, 0106; sensor 150, cameras 131 and 132, and processor 211, Fig. 4).
Electroencephalogram determination device and electroencephalogram determination section (see paragraph 0059) is interpreted to be a module of a processor (see element 222, Fig. 4).
Action analysis device and action analysis section (Paragraph 0138) is interpreted to be a module of a processor (element 221, Fig. 4).
Storage device is interpreted as storage and memory which interacts with a processor (Element 110, Fig. 3).
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Utilizing the two step process adopted by the Supreme Court (Alice Corp vs CLS Bank Int'l, US
Supreme Court, 110 USPQ2d 1976 (2014) and the recent 101 guideline Federal Register Vol. 84, No., Jan
2019)), determination of the subject matter eligibility under the 35 U.S.C. 101 is as follows: Specifically, the Step 1 requires claim belongs to one of the four statutory categories (process, machine, manufacture, or composition of matter). If Step 1 is satisfied, then in the first part of Step 2A (Prong One), identification of any judicial recognized exceptions in the claim is made. If any limitation in the claim is identified as judicial recognized exception, then in the second part of Step 2A (Prong Two), determination is made whether the identified judicial exception is being integrated into practical application. If the identified judicial exception is not integrated into a practical application, then in Step 2B, the claim is further evaluated to see if the additional elements, individually and in combination provide "inventive concept" that would amount to significantly more than the judicial exception. If the element and combination of elements do not amount to significantly more than the judicial recognized exception itself, then the claim is ineligible under the 35 U.S.C. 101.
Claims 1 and 3-11 are rejected under 25 U.S.C. 101.
Claim 1 is rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception, in this case an abstract idea, without significantly more. The claim recite(s) "determine whether an abnormality is found in the electroencephalogram data based on the electroencephalogram data and the action data”, “carry out predetermined processing in response to a result of determination indicating that the abnormality has been found", and “determine whether the user is awake based on the action data”. This judicial exception is not integrated into a practical application and the claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception.
Claim 1 satisfies Step 1, namely the claim is directed to one of the four statutory classes, machine. Following Step 2A Prong one, any judicial exceptions are identified in the claims. In claim 1, the limitations "determine whether an abnormality is found in the electroencephalogram data based on the electroencephalogram data and the action data”, “carry out predetermined processing in response to a result of determination indicating that the abnormality has been found", and “determine whether the user is awake based on the action data” are abstract ideas as they are directed to a mental process or mathematical calculation, as determining whether an abnormality is found and determining whether a user is awake may be performed via visual observation and judgment of data points or signals or may be determined using basic mathematical operations such as applying a threshold or mathematical transform to the data or signal. Similarly, “predetermined processing” may constitute further mental processes or mathematical concepts as the broadest reasonable interpretation encompasses making further judgments or mathematical transforms using the data, such as, for example matching a pattern or threshold of the abnormality with known causes. With the identification of an abstract idea, the next phase is to proceed Step 2A, Prong Two, wherewith additional elements and taken as a whole, evaluation occurs of whether the identified abstract idea is integrated into a practical application.
In Step 2A, Prong Two, the claim does not recite any additional elements or evidence that amounts to significantly more than the judicial exception. Besides the abstract idea, the claim recites “an electroencephalogram measurement device configured to output electroencephalogram data on a user; an action measurement device configured to output action data on the user; an electroencephalogram determination device”, “a controller”, “an action analysis device”, and “a storage device, wherein the controller is configured to: in response to the result of determination that the abnormality has been found, store abnormality information indicating the abnormality has been found in the storage device; and in a case where the abnormality information is stored in the storage device, provide an abnormality notification for notifying that the abnormality has been found in the electroencephalogram data and delete the abnormality information in a period in which the result of determination indicates that the user is awake and also the result of determination indicates that no abnormality is found”. However, these components may be seen as the use of well-understood, routine, or conventional elements to perform a non-mental process in order to gather data for the mental process step or output data from the mental process step, much like the examples given in MPEP 2106.04(d)(2)(c) and MPEP 2106.05(g), such that these limitations are extra-solution activity and thus do not integrate the judicial exception into a practical application. In particular, the additional limitations of instant claim 1 appear to be similar to the examples of “performing clinical tests on individuals to obtain input for an equation” and “determining the level of a biomarker in blood” where data (such as electroencephalogram data and action data” is collected for later use in a diagnosis and which were found to be insignificant extra-solution activity. See In re Grams, 888 F.2d 835, 839-40; 12 USPQ2d 1824, 1827-28 (Fed. Cir. 1989) and Mayo, 566 U.S. at 79, 101 USPQ2d at 1968. See also PerkinElmer, Inc. v. Intema Ltd., 496 Fed. App'x 65, 73, 105 USPQ2d 1960, 1966 (Fed. Cir. 2012), respectively. Furthermore, the additional limitation of providing a notification may be seen as similar to the example of “presenting offers” as the notification as claimed may be seen as a generic presentation while storing or deleting the data is a form of selecting a particular data source or type of data to manipulated akin to “taking food orders from only table-based customers or drive-through customers” as the claimed limitation similarly selects for a type of data (indicating an abnormality has been found versus indicating that no abnormality is found), where each of these limitations has additionally been found to be insignificant extra-solution activity. See Mayo, 566 U.S. at 79, 101 USPQ2d at 1968; OIP Techs., Inc. v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1092-93 (Fed. Cir. 2015) and Ameranth, 842 F.3d at 1241-43, 120 USPQ2d at 1854-55, respectively. The steps of outputting data lead to the limitations of “determin[ing]” and “processing”, while the limitations identified as abstract in Step 2A Prong 1 lead to storing data and providing a notification such that the end result of use of the system is only the generic notification which may include any generic output, or no output at all in cases where no abnormality has been found. As this is not defined as requiring any further action, such as a form of prophylaxis or treatment or an improvement to a computer or other technology, the claim limitations constitute mere generation of data, in this case the generation of electroencephalogram and action data, such that the claim does not integrate the judicial exception into any practical application. Regarding “an electroencephalogram determination device”, “a controller”, “a storage device”, the limitations amount to nothing more than an instruction to apply the abstract idea using a generic computer, which does not render an abstract idea eligible. The steps performed by the device, the controller, and the action analysis device are, as claimed, capable of being performed in the human mind similar to the examples given in MPEP 2106.04(a)(2)(III)(A)-(C), wherein it is described that “a claim to ‘collecting information, analyzing it, and displaying certain results of the collection and analysis’ where the data analysis steps are recited at a high level of generality such that they could practically be performed in the human mind” recites a mental process and that claims which merely use a computer as a tool to perform a mental process are not eligible when “there is nothing in the claims themselves that foreclose them from being performed by a human, mentally or with pen and paper” such as “mental processes of parsing and comparing data” when the steps are recited at a high level of generality and a computer is used merely as a tool to perform the processes. Under the broadest reasonable interpretation, the claim elements are recited with a high level of generality (as written, each claimed step may be performed by a user mentally or with the aid of pen and paper after acquiring data from the additional elements) that there are no meaningful limitations to the abstract idea. Consequently, with the identified abstract idea not being integrated into a practical application, the next step is Step 2B, evaluating whether the additional elements provide "inventive concept" that would amount to significantly more than the abstract idea.
In Step 2B, claim 1 does not include additional elements that are sufficient to amount to significantly more than the judicial exception. The limitation of “an electroencephalogram measurement device configured to output electroencephalogram data on a user; an action measurement device configured to output action data on the user; an electroencephalogram determination device”, “a controller”, “an action analysis device”, and “a storage device, wherein the controller is configured to: in response to the result of determination that the abnormality has been found, store abnormality information indicating the abnormality has been found in the storage device; and in a case where the abnormality information is stored in the storage device, provide an abnormality notification for notifying that the abnormality has been found in the electroencephalogram data and delete the abnormality information in a period in which the result of determination indicates that the user is awake and also the result of determination indicates that no abnormality is found” constitutes extra-solution activity to the judicial exception, which does not amount to an inventive concept when the activity is well-understood, routine, or conventional, and are thus not indicative of integration into a practical application. The claim limitation constitutes adding generic sensors, processors, and storage, which Yocca (US 20220202373 A1) describes as well-understood, routine or conventional in its description of wearable sensors for monitoring a user and various processors working with memory to execute functions and provide notifications to the user for decision support which are generic and/or commercially available and are well known in the art (Paragraph 0095-0096, 0101, 0106-0109--A wide range of devices/sensors, such as, for example, a smartphone (e.g., iPhone (BYOD or provisioned)), accelerometers and gyroscopes, portable devices, digital devices, smart fabrics, bands and actuators, smartwatch (e.g., an Apple watch (e.g., Apple watch 3) or iWatch), patch such as MC10 Patch, Oura rings (for example, for patients unable to or that do not want to wear a smartwatch, or high-functioning patients), Android devices, sensors like Microsoft Kinect, wireless communication networks and power supplies, and data capture technology for processing and decision support or any conventional or non-conventional device/sensor performing similar functions can be and/or be included in the automated monitoring device). As discussed above with respect to integration of the abstract idea into a practical application, the present elements amount to no more than mere indications to apply the exception.
In Summary, claim 1 recites abstract idea without being integrated into a practical application, and does not provide additional elements that would amount to significantly more. As such, taken as a whole, the claim and is ineligible under the 35 U.S.C. 101.
Claims 3-9 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception, in this case an abstract idea, without significantly more. As each of these claims depends from claim 1, which was rejected under 35 U.S.C. 101 in paragraph 8 of this action, these claims must be evaluated on whether they sufficiently add to the practical application of claim 1, or comprise significantly more than the limitations of claim 1.
Besides the abstract idea of claim 1: claims 3-9 recite further abstract ideas and additional elements that are well-understood, routine or conventional (the action analysis device, storage device, communication interface which constitute adding generic memory, processing, and transmitter which are additionally shown to be well-understood, routine, or conventional through the disclosure of Yocca cited above) along with providing mere data output which is considered insignificant post-solution activity, as the output (in this case, the notification, the restriction signal, the restriction request signal, or the startup signal) provides no particular prophylaxis or treatment step and may be any generic output and as the steps of storing, deleting, and logging data and beginning a determination may be seen as using a computer to perform a tool of a mental process, where these steps function similarly to gathering, retaining or ignoring data as relevant;
The claim element of claim 1 of a user assistance system is recited with a high level of generality (as written, the actions of the processing circuitry may be carried out by a person alone or with a generic computer in any undefined manner). This limitation provides no practical application, nor does it provide meaningful limitations to the abstract idea.
Claims 10 and 11 are rejected for similar reasons to claim 1, where the “sections” are interpreted the same as the corresponding “devices” of claim 1 and the information processor is interpreted as being the same as the “controller” of claim 1.
Response to Arguments
Applicant's arguments filed 29 June 2026 have been fully considered but they are not persuasive.
The applicant argues that the claims do not recite a mental process as “the claimed determination cannot be performed by a human mind, because it requires electroencephalogram data” which “a human mind can neither acquire nor generate” and further states that a person “cannot perceive his or her own electroencephalogram by observation” and that “the claim does not recite a human reviewing a pre-printed chart”.
However, as described above in this action, the limitations relating to the collection of data are insignificant extra-solution activity rather than themselves being drawn to an abstract idea. While the claim does not itself recite “a human reviewing a pre-printed chart” there is no limitation which would preclude a human from performing the claimed steps using such a pre-printed chart as the data to be analyzed as the basis for determinations.
The applicant additionally argues that the claims “recite no formula, equation, or calculation, and a limitation is not a mathematical concept merely because it could be performed using mathematical operations”.
However, per MPEP 2106.04(a)(2), “a claim does not have to recite the word "calculating" in order to be considered a mathematical calculation. For example, a step of "determining" a variable or number using mathematical methods or "performing" a mathematical operation may also be considered mathematical calculations when the broadest reasonable interpretation of the claim in light of the specification encompasses a mathematical calculation”. As determining an abnormality or the wake/sleep state of the user may be done using mathematical methods, the broadest reasonable interpretation of the claim in light of the specification encompasses a mathematical calculation.
The applicant additionally argues that the amended claims integrate any judicial exception into a practical application because the claims describe suppressing a notification at the time of detection in order “to time the notification to a window in which the user can receive and act on it”. The applicant further argues that this is analogous to the eligible claim of Example 42 of the Subject Matter Eligibility Examples. The applicant further argues that this conditional notification and deletion sequence is not mere extra-solution activity, and that the measurement devices are not mere data-gathering supporting a mental step because the action data is used to determine whether the user is awake, which provides a condition for the conditional notification and deletion operations.
However, claim 1 of Example 42 is not analogous to the current claims. Claim 1 of Example 42 is noted as a specific improvement over prior art systems because it allows remote users to share information in real time in a standardized format regardless of the format in which the information was input by the user. The instant claims provide no such improvement and merely serve to delay a timing of a generic output after a series of determinations have been made. As described above in this action, the suppression of the notification based on the determinations is a form of selecting a particular data source or type of data to manipulated akin to “taking food orders from only table-based customers or drive-through customers” as the claimed limitation similarly selects for a type of data (indicating an abnormality has been found versus indicating that no abnormality is found, and if a user is awake or asleep), where this limitation has additionally been found to be insignificant extra-solution activity. See Ameranth, 842 F.3d at 1241-43, 120 USPQ2d at 1854-55, respectively.
The applicant additionally argues that the findings of the elements as well-understood, routine, or conventional “say nothing about suppressing and time-gating an abnormality notification to a detected awake-and-no-abnormality window” and thus “does not establish the claimed ordered combination”.
However, the applicant is combining the analysis of the abstract ideas of the claims (determining an abnormality and whether the user is awake or asleep) with the extra-solution activity of the claims (the output of a notification and storing or deleting of data) in order to argue that the additional elements are not well-understood, routine, or conventional even though the inventive concept of Step 2B can only be supplied by the additional element and not the abstract idea. The particular additional elements being argued by applicant amount merely to providing a notification and storing or deleting data, where these actions are conditional upon the determinations of the abstract limitations. As described above in this action, the use of sensing and processing elements to provide a notification to a user for decision support and to store or delete data (which are generic computer functions) is well-understood, routine, or conventional in the art as evidenced by Yocca.
The claims remain rejected under 35 U.S.C. 101.
Conclusion
It is noted that as none of “restriction signal”, “restriction request signal”, and “startup signal” are noted as requiring a specific interpretation, the broadest reasonable interpretation of these limitations of the claims encompasses the transmission of signals to a caregiver to restrict or prompt activities via some application of the external terminal device used by the caregiver and presented upon the interface of that external device.
No rejection under 35 U.S.C. 102/103 has been applied to claims 1 and 3-11. The prior art of the record fails to teach and/or fairly suggest “provide an abnormality notification for notifying that the abnormality has been found in the electroencephalogram data and delete the abnormality information in a period in which the result of determination indicates that the user is awake and also the result of determination indicates that no abnormality is found” of claims 1, 10, and 11.
Yocca (US 20220202373 A1—previously cited) and Howard (US 20200037942 A1—previously cited) disclose an electroencephalogram measurement device configured to output electroencephalogram data on a user; an action measurement device configured to output action data on the user; an electroencephalogram determination device configured to determine whether an abnormality is found in the electroencephalogram data based on the electroencephalogram data and the action data; and a controller configured to carry out predetermined processing in response to a result of determination indicating that the abnormality has been found. However, neither Yocca nor Howard discloses nor fairly suggests “provide an abnormality notification for notifying that the abnormality has been found in the electroencephalogram data and delete the abnormality information in a period in which the result of determination indicates that the user is awake and also the result of determination indicates that no abnormality is found”.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNA ROBERTS whose telephone number is (571)272-7912. The examiner can normally be reached M-F 8:30-4:30 EST.
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/ANNA ROBERTS/ Examiner, Art Unit 3791
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