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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on May 20, 2026 has been entered. By this amendment, claims 1 and 11 are amended and claims 1-2, 4, 6-18, 20 and 22-24 are now pending in the application.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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 1, 2, 4, 9-13, 17, 18, 20, and 22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bentwich (U.S. 2013/0267761, previously cited). Regarding claim 1, Bentwich discloses a system for improving cognitive function (see Figure 1), comprising: a non-invasive brain stimulation device 102 (“In accordance with a preferred embodiment of the present invention the brain stimulator and imaging device 102 is a medical device capable of selectively stimulating various regions of the brain, either excitatory or inhibitory stimuli. Various such devices are known in the art, including inter alia various Magnetic Photo-Electric Stimulator (MPES) devices, Transcranial Magnetic Stimulation (TMS) and Deep TMS devices.”, paragraph [0022]); a human computer interface 104 (“the cognitive stimulator and assessment device 104 is a computer having a computer monitor and optionally a user-input device, such as a keyboard or a microphone”, paragraph [0026]); and a computer 106 configured to control the non-invasive brain stimulation device and the human computer interface (“The integrated treatment controller device 106 is a computer running a computer program, which computer program is constructed and operative to control the brain stimulator and imaging device 102, and the cognitive stimulator and assessment device 104.”, paragraph [0027]) to: assess a subject's baseline cognitive function by interaction with the subject using the human computer interface (“The cognitive analyzer 114 measures a cognitive feature in the patient 100.”, paragraph [0049]), and if the subject's baseline cognitive function is impaired: use the human computer interface to provide the subject, prior to conducting a cognitive function training of the subject, with a strategy for improving performance in a cognitive function test (“Based on this initial data 136, the stimulator controller 130 determines the neuronal and cognitive stimuli appropriate for an individual patient.”, paragraph [0057], where the recitation “prior to conducting a cognitive function training of the subject” merely requires that the strategy is provided before a single cognitive function training, not that the strategy is provided prior to conducting any cognitive function training), wherein the strategy is tailored to the subject based on the subject’s individual strengths and weaknesses ((“Based on this initial data 136, the stimulator controller 130 determines the neuronal and cognitive stimuli appropriate for an individual patient.”, paragraph [0057]) and/or prior empirically determined knowledge of the efficacy of different training strategies (“The cognitive analyzer preferably utilizes at least one of various cognitive diagnostic techniques known in the art such as Stroop Color Task, Navon Global Local Paradigm, Dimensional Meaning Profile, various memory, intelligence, language, personality tests, cognitive-affective measurement tools, and tests for locating brain region deficiency in a disease state, such as in patients suffering from depression.”, paragraph [0031], where the Stroop Color Task, Navon Global Local Paradigm, and Dimensional Meaning Profile are all known cognitive function tests that include the instruction on how to perform the test included within the testing procedure itself and wherein it is respectfully submitted that instructions on how to perform the testing procedure would satisfy the broadest reasonable interpretation for “prior empirically determined knowledge of the efficacy of different training strategies”, as the efficacy of providing instructions prior to performing a tests is inherently known); and stimulate the subject's brain with the non-invasive brain stimulation device during the cognitive function training (“The integrated treatment controller 116 comprises a stimulator controller 130, operative to control the stimulator 118 (FIG. 2), so as to personalize the neuronal and cognitive stimulation of the ICONS device of the present invention, adjusting it to an individual patient, such as the patient 100.”, paragraph [0056]).
Regarding claim 2, Bentwich discloses that the non-invasive brain stimulation device comprises a transcranial electrical brain stimulator configured to apply at least one of: DC current stimulation; AC current stimulation and random noise stimulation (“stimulating at least one region of a brain of the patient with magnetic stimulation or with electric stimulation”, claim 1).
Regarding claim 4, Bentwich discloses that the computer is configured to monitor the subject's cognitive performance during the cognitive function training and to adjust at least one of: the cognitive function test, strategy for improving performance; and non-invasive brain stimulation in dependence on the result of the monitoring (“The cognitive feedback detector 128 is a device operative to measure changes in cognitive properties of the patient 100 in response to stimulation of the stimulator 118.”, paragraph [0040]).
Regarding claim 9, Bentwich discloses that the cognitive function comprises or consists of at least one of: working memory; attention, long term memory and executive control (“The cognitive feature is preferably measured by various cognitive tests known in the art, such as Stroop Color Task, Navon Global Local Paradigm, Dimensional Meaning Profile, various memory, intelligence, language, personality tests, cognitive-affective measurement tools, and tests for locating brain region deficiency, e.g., frontal-temporal deficiency.”, paragraph [0049]).
Regarding claim 10, Bentwich discloses that the system is configured for operation by the subject in their own home (the configuration shown in Figure 1 where the patient is lying on a table with monitor 104 overhead and stimulator device 102 on their head is respectfully submitted to be a configuration “for operation by the subject in their own home”).
Regarding claim 11, Bentwich discloses a method of improving cognitive function in a subject comprising: assessing the subject's baseline cognitive function (“The cognitive analyzer 114 measures a cognitive feature in the patient 100.”, paragraph [0049]), and if the subject's baseline cognitive function is impaired: providing the subject, prior to conducting a cognitive function training of the subject, with a strategy for improving performance in a cognitive function test (“Based on this initial data 136, the stimulator controller 130 determines the neuronal and cognitive stimuli appropriate for an individual patient.”, paragraph [0057], where the recitation “prior to conducting a cognitive function training of the subject” merely requires that the strategy is provided before a single cognitive function training, not that the strategy is provided prior to conducting any cognitive function training), wherein the strategy is tailored to the subject based on the subject’s individual strengths and weaknesses (“Based on this initial data 136, the stimulator controller 130 determines the neuronal and cognitive stimuli appropriate for an individual patient.”, paragraph [0057]) and/or prior empirically determined knowledge of the efficacy of different training strategies (“The cognitive analyzer preferably utilizes at least one of various cognitive diagnostic techniques known in the art such as Stroop Color Task, Navon Global Local Paradigm, Dimensional Meaning Profile, various memory, intelligence, language, personality tests, cognitive-affective measurement tools, and tests for locating brain region deficiency in a disease state, such as in patients suffering from depression.”, paragraph [0031], where the Stroop Color Task, Navon Global Local Paradigm, and Dimensional Meaning Profile are all known cognitive function tests that include the instruction on how to perform the test included within the testing procedure itself and wherein it is respectfully submitted that instructions on how to perform the testing procedure would satisfy the broadest reasonable interpretation for “prior empirically determined knowledge of the efficacy of different training strategies”, as the efficacy of providing instructions prior to performing a tests is inherently known); and stimulating the subject's brain by non-invasive brain stimulation while they undertake the cognitive function training (“The integrated treatment controller 116 comprises a stimulator controller 130, operative to control the stimulator 118 (FIG. 2), so as to personalize the neuronal and cognitive stimulation of the ICONS device of the present invention, adjusting it to an individual patient, such as the patient 100.”, paragraph [0056]).
Regarding claim 12, Bentwich discloses monitoring the subject's cognitive performance during the cognitive function training (“The feedback data 142 is an optional aspect of the present invention, allowing fine-tuning of the operation of the stimulator 118, and is preferably generated and passed on to the stimulator controller 130, iteratively, during the process of treatment.”, paragraph [0059]).
Regarding claim 13, Bentwich discloses adjusting at least one of: the cognitive function training, strategy for improving performance; and non- invasive brain stimulation in dependence on the result of the monitoring (“The feedback data 142 is an optional aspect of the present invention, allowing fine-tuning of the operation of the stimulator 118, and is preferably generated and passed on to the stimulator controller 130, iteratively, during the process of treatment.”, paragraph [0059]).
Regarding claim 17, Bentwich discloses that the cognitive function comprises or consists of at least one of: working memory; attention, long term memory and executive control (“The cognitive feature is preferably measured by various cognitive tests known in the art, such as Stroop Color Task, Navon Global Local Paradigm, Dimensional Meaning Profile, various memory, intelligence, language, personality tests, cognitive-affective measurement tools, and tests for locating brain region deficiency, e.g., frontal-temporal deficiency.”, paragraph [0049]).
Regarding claim 18, Bentwich discloses that the non-invasive transcranial stimulation comprises electrical transcranial stimulation; the electrical transcranial stimulation comprising at least one of: DC current stimulation; AC current stimulation and random noise stimulation (“stimulating at least one region of a brain of the patient with magnetic stimulation or with electric stimulation”, claim 1).
Regarding claim 20, Bentwich discloses that i) the cognitive function training and/or the assessment of the subject's cognitive function is computer implemented: and/or ii) the cognitive function training and/or the assessment of the subject's cognitive function comprises an adaptive computer implemented cognitive function test (“The integrated treatment controller device 106 is a computer running a computer program, which computer program is constructed and operative to control the brain stimulator and imaging device 102, and the cognitive stimulator and assessment device 104.”, paragraph [0027]).
Regarding claim 22, Bentwich discloses that the strategy comprises an elaborative encoding mnemonic (“the proposed Integrative Therapeutic Application calls for a powerful synergy between the stimulation of Brain (or CMPES' bodily) "deficient" (e.g., hypo- or hyper-activation/function/structure) regions and the direct training of these brain (or bodily) "deficient" capabilities through (existing or novel) training methodologies (such as mnemonic, semantic, reasoning, mathematical, physical, etc.) that specifically improve the functional (or structural capabilities) of these deficient Brain/Cognitive-Behavioral/Physiological/Medical Capabilities.”, paragraph [0074]).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 6-8, 14-16, 23 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Bentwich (U.S. 2013/0267761, cited above) in view of Min (U.S. 2019/0261877). Regarding claims 6-8 and 14-16, Bentwich discloses the invention substantially as claimed, but fails to disclose an EEG measurement device, configured to monitor the subject's cognitive performance: i) during assessment of the subject's baseline cognitive performance; and/or ii) while the subject undertakes the cognitive function training, wherein the EEG measurement device and the non-invasive brain stimulation device are a unified wearable device and the computer is configured to monitor the subjects' cognitive function using EEG biomarkers that are modulated by brain mechanisms linked to the cognitive function, for example EEG biomarkers comprising one or more of: EEG frequency components; power levels within specific frequency ranges; and cross-frequency coupling. Min teaches a method for enhancing cognitive function that includes an EEG measurement device 200 configured to monitor the subject's cognitive performance: i) during assessment of the subject's baseline cognitive performance; and/or ii) while the subject undertakes the cognitive function training (“measuring electroencephalogram (EEG) of the subject that is executing the cognitive task”, paragraph [0011]), wherein the EEG measurement device and the non-invasive brain stimulation device are a unified wearable device (see Figure 3) and the computer is configured to monitor the subjects' cognitive function using EEG biomarkers that are modulated by brain mechanisms linked to the cognitive function, for example EEG biomarkers comprising one or more of: EEG frequency components; power levels within specific frequency ranges; and cross-frequency coupling (“measuring electroencephalogram (EEG) of the subject that is executing the cognitive task”, paragraph [0011]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Bentwich to include an EEG measurement device, configured to monitor the subject's cognitive performance: i) during assessment of the subject's baseline cognitive performance; and/or ii) while the subject undertakes the cognitive function training, wherein the EEG measurement device and the non-invasive brain stimulation device are a unified wearable device and the computer is configured to monitor the subjects' cognitive function using EEG biomarkers that are modulated by brain mechanisms linked to the cognitive function, for example EEG biomarkers comprising one or more of: EEG frequency components; power levels within specific frequency ranges; and cross-frequency coupling, as taught by Min, in order to have additional monitoring capabilities, and as it has been held that combining prior art elements according to known methods to yield predictable results requires only routine skill in the art. KSR Int'l Co. v. Teleflex Inc., 127 S.Ct. 1727, 1742, 82 USPQ2d 1385, 1396 (2007).
Regarding claims 23 and 24, Bentwich discloses the invention substantially as claimed, but fails to disclose that the cognitive function test comprises an nback test for assessment of working memory and the strategy comprises stages of: i) memorising a working set of n steps of the nback; ii) comparing the current item with the working set; iii) updating the working set to discard the oldest member. Min teaches a method for enhancing cognitive function that includes a cognitive function test comprises an nback test for assessment of working memory (“in an embodiment, association between the working memory function (one example of specific cognitive functions) of the subject and the measured individual cognitive frequency may be seen in real time using the working memory evaluation method such as…the N-back task”, paragraph [0075]) and the strategy comprises stages of: i) memorising a working set of n steps of the nback; ii) comparing the current item with the working set; iii) updating the working set to discard the oldest member (“the N-back task (a task for evaluating working memory where stimuli are consecutively presented, and the subject is asked whether stimulus appearing after N.sup.th stimulus of a specific stimulus is equal to stimulus appearing before N.sup.th stimulus in the presented list of stimuli).”, paragraph [0075] and “For example, the 3-back task is a task in which the subject is presented number or letter stimuli one by one, and needs to decide if the current stimulus is the same as one presented third trials ago, and it also requires the subject to retain the corresponding information for a specific period of time, and can be used to evaluate working memory.”, paragraph [0076]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Bentwich to include that the cognitive function test comprises an nback test for assessment of working memory and the strategy comprises stages of: i) memorising a working set of n steps of the nback; ii) comparing the current item with the working set; iii) updating the working set to discard the oldest member, as taught by Min, in order to effectively evaluate working memory, and as it has been held that combining prior art elements according to known methods to yield predictable results requires only routine skill in the art. KSR Int'l Co. v. Teleflex Inc., 127 S.Ct. 1727, 1742, 82 USPQ2d 1385, 1396 (2007).
Response to Arguments
Applicant's arguments filed May 20, 2026 have been fully considered but they are not persuasive. Regarding the Examiner Interview conducted on April 21, 2026, Applicant indicates that during the interview the Examiner indicated that the proposed amendments appeared likely to overcome the present rejections and the Examiner was not presently aware of any 102 or 103 rejections. It is respectfully submitted, that as set forth in the Examiner Interview Summary Record of 4/23/2026, Applicant merely proposed general amendments, but failed to provide specific claim language, and while the Examiner indicated such amendments as being beneficial, without the language, the Examiner was unable to say definitively if such amendments overcome the previous rejections. As set forth above, the amendments failed to overcome the Bentwich reference. Perhaps, as set forth in the Examiner Interview Summary Record of 4/23/2026, more detail from paragraphs [0096]-[0097] setting forth the patient specific strategy would be beneficial in overcoming the reference.
Regarding the previous rejections of claims 1 and 11 as being anticipated by Bentwich, the Applicant argues that Bentwich fails to anticipate the claims for three reasons. First, Applicant argues that Bentwich does not disclose providing the subject, prior to conducting cognitive function training, with a strategy for improving performance because Bentwich discloses that the stimulator controller determines neuronal and cognitive stimuli appropriate for an individual patient, which Applicant argues is different from using a human computer interface to provide the subject with a strategy before cognitive function training. As set forth above, the instructions provided to the subject by the human computer interface is considered the strategy for improving performance.
The Applicant secondly argues that Bentwich fails to disclose that the strategy is tailored to the subject based on the subject’s individual strengths and weaknesses and/or empirically determined knowledge of the efficacy of different training strategies. It is respectfully submitted that, as set forth above, Bentwich discloses “the stimulator controller 130 determines the neuronal and cognitive stimuli appropriate for an individual patient”, where the “cognitive stimuli appropriate for an individual patient” is considered the strategy “based on the subject’s individual strengths and weaknesses” and the instructions for performing the test are considered the “empirically determined knowledge of the efficacy of different training strategies” as claimed.
The Applicant thirdly argues that Bentwich’s disclosure of cognitive test procedures or instructions for performing a test is not the claimed strategy, but rather the claimed strategy is a technique provided to the subject for improving cognitive performance. Applicant alleges that instructions explaining how to undertake a test do not themselves constitute a strategy for improving performance in that tests. Applicant argues that this distinction is consistent with the specification, which describes strategies such as visual or auditory mnemonics, elaborative encoding mnemonics, method of loci, mnemonic peg systems, and strategies based on subject-specific strengths and weaknesses or empirical knowledge of strategy efficacy. However, the specific strategies are not present in the independent claim. Further, Applicant’s specification supports the interpretation of the instructions explaining how to undertake a test as constituting a strategy, with the disclosure “Before starting the first session with concurrent tDCS (ACTIVE or SHAM) and the adaptive nback training task, half of the participants were provided with clear instructions on how to undertake the working memory training.” at page 17, lines 29-31. If Applicant intends for a different interpretation for strategy to be used, Applicant is advised to amend the claims to clarify the intended parameters for a strategy. For at least the reasons given above, the rejections stand.
Regarding the rejection of claims 6-8, 14-16, 23, and 24 as being unpatentable over Bentwich in view of Min, Applicant argues that Min fails to cure the deficiencies of Bentwich with respect to claims 1 and 11. As discussed above, Bentwich satisfies the limitations of claims 1 and 11 and, as such, the argument is moot.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TAMMIE K MARLEN whose telephone number is (571)272-1986. The examiner can normally be reached Monday through Friday from 8 am until 4 pm.
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/TAMMIE K MARLEN/Primary Examiner, Art Unit 3796
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