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 .
Status of Claims
Claims 1-20 were previously pending and subject to a non-final Office Action having a notification date of November 13, 2025 (“non-final Office Action”). Following the non-final Office Action, Applicant filed an amendment on March 13, 2025 (the “Amendment”), amending claims 1 and 11.
The present Final Office Action addresses pending claims 1-20 in the Amendment.
Response to Arguments
Response to Applicant’s Arguments Regarding Claim Rejections Under 35 USC §101
At page 10 of the Amendment, Applicant initially asserts that the present claims do not recite "mental processes" but instead are directed to a "technical solution for treating psychiatric disorders." The Examiner disagrees that the present claims do not recite mental processes because a user could practically in their mind with pen and paper retrieve (e.g., via reviewing/looking at it on a screen or the like) a "keyed dataset" including a key/identifier of a corresponding subject/patient, logic/classification rules, and a “subject connectivity value” representative of a magnitude of a connection at a first time associated with first and second sub-processing regions of a subject associated with symptoms of an affective disorder and derived from an imaging scan/test; apply classification rules to determine that the subject connectivity value exceeds a threshold for the connection to indicate that the subject is eligible for a cognitive-emotional training session; and identify, responsive to the cognitive-emotional training session, a subsequent subject connectivity value representing a magnitude measured at a second time of a connection between the first sub-processing region and the second sub-processing region of the nervous system of the subject (e.g., again, via reviewing resulting measurements on a screen or the like during/after the cognitive-emotional training session). These recitations, under their broadest reasonable interpretation, are similar to the concepts of collecting information, analyzing it and displaying certain results of the collection and analysis in Electric Power Group, LLC, v. Alstom (830 F.3d 1350, 119 USPQe2d 1739 (Fed. Cir. 2016)).
Furthermore, the Examiner submits that the present claims recite “certain methods of organizing human activity” because they relate to managing personal behavior or relationships or interactions between people (e.g., social activities, teaching, and following rules or instructions). For instance, the recited steps of retrieving the keyed dataset, applying the rules to determine that the subject connectivity value exceeds a threshold indicative that a subject is eligible for a cognitive-emotional training session, and identifying a subsequent subject connectivity value are similar to a mental process that a neurologist should follow when testing a patient for nervous system malfunctions, In re Meyer, 688 F.2d 789, 791-93, 215 USPQ 193, 194-96 (CCPA 1982).
Applicant then takes the position that the step of "[providing]…an instruction for presentation of the [CET] session to the subject …to address the symptom of the affective disorder" amounts to a particular treatment/prophylaxis under MPEP 2106.04(d)(2). While the Examiner does not necessarily assert that providing an instruction for presentation of a CET session to address affective disorder symptoms has only a nominal/insignificant relationship to the judicial exception (i.e., the mental processes and certain methods of organizing human activity discussed herein) under MPEP 2106.04(d)(2)(b), the Examiner asserts that the presented CET session instruction is not "particular" under MPEP 2106.04(d)(2)(a) and is merely extra-solution activity under MPEP 2106.04(d)(2)(c). With respect to factor (a), there are no details regarding an amount of type of the CET session (e.g., in relation to a normal amount/type per MPEP 2106.04(d)(2)(a)), scheduling for the CET session. With respect to factor (c), provision of the CET session instruction appears to be performed in order to gather data for the subsequent mental analysis step of "[identifying], responsive to the [CET] session, a subsequent subject connectivity value…" and is a necessary precursor for all uses of the recited exception (and thus is extra-solution activity).
When factors (a), (b), and (c) are considered collectively, the entirety points to the above limitation not integrating the judicial exception(s) into a practical application.
The 35 USC 101 rejection is maintained.
Response to Applicant’s Arguments Regarding Claim Rejections Under 35 USC §103
In relation to Applicant’s position on page 10 of the Amendment that the disclosures of John and Dunlop do not disclose or suggest either alone or in any combination the limitations of claims 1 and 11, the Examiner disagrees as set forth in the rejection below.
Claim Objections
Claims 1 and 11 are objected to because of the following informalities:
In claim 1, line 7, it appears that "including subject" should be changed to --including a subject--.
In claim 11, line 5, it appears that "including subject" should be changed to --including a subject--.
Appropriate correction is required.
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 1-20 are rejected under 35 U.S.C. §101 because the claimed invention is directed to an abstract idea without significantly more.
Subject Matter Eligibility Criteria - Step 1:
Claims 1-10 are directed to a system (i.e., a machine) and claims 11-20 are directed to a method (i.e., a process). Accordingly, claims 1-20 are all within at least one of the four statutory categories. 35 USC §101.
Subject Matter Eligibility Criteria - Alice/Mayo Test: Step 2A - Prong One:
Regarding Prong One of Step 2A of the Alice/Mayo test (which collectively includes the guidance in the January 7, 2019 Federal Register notice and the October 2019 update issued by the USPTO as now incorporated into the MPEP, as supported by relevant case law), the claim limitations are to be analyzed to determine whether, under their broadest reasonable interpretation, they “recite” a judicial exception or in other words whether a judicial exception is “set forth” or “described” in the claims. MPEP 2106.04(II)(A)(1). An “abstract idea” judicial exception is subject matter that falls within at least one of the following groupings: a) certain methods of organizing human activity, b) mental processes, and/or c) mathematical concepts. MPEP 2106.04(a).
Representative independent claim 1 includes limitations that recite at least one abstract idea. Specifically, independent claim 1 recites:
A system, comprising:
a data processing system comprising one or more processors coupled with memory, the data processing system configured to:
retrieve, from a hardware storage device maintaining one or more data structures storing (i) a plurality of keyed datasets, each of the plurality of keyed datasets including a respective key that represents a corresponding subject and (ii) executable logic defining classification rules, a keyed dataset including a subject connectivity value derived from at least one of an imaging scan or test provided to a subject represented by a key in the keyed dataset, the subject connectivity value representing a magnitude measured at a first time of a connection between a first sub-processing region and a second sub-processing region of a nervous system of the subject associated with a symptom of an affective disorder;
execute the executable logic against the keyed dataset to apply the classification rules to determine that the subject connectivity value of the subject exceeds a connectivity threshold value for the connection between the first sub-processing region and the second sub-processing region to indicate that the subject is eligible for a cognitive-emotional training session;
store, on the hardware storage device, using the one or more data structures, at least an association between the key represented in the keyed dataset and a classification value to indicate that the subject is eligible for the cognitive-emotional training session;
provide, responsive to the association between the key and the classification value, an instruction for presentation of the cognitive-emotional training session to the subject to induce activation of the first sub-processing region or the second sub-processing region of the nervous system of the subject to address the symptom of the affective disorder;
identify, responsive to the cognitive-emotional training session, a subsequent subject connectivity value, the subsequent subject connectivity value representing a magnitude measured at a second time of a connection between the first sub-processing region and the second sub-processing region of the nervous system of the subject; and
store, on the hardware storage device, the subsequent subject connectivity value.
The Examiner submits that the foregoing underlined limitations constitute “a mental process” because they are observations/evaluations/judgments/analyses that can, at the currently claimed high level of generality, be practically performed in the human mind (e.g., with pen and paper). As an example, a user could practically in their mind with pen and paper retrieve (e.g., via reviewing/looking at it on a screen or the like) a "keyed dataset" including a key/identifier of a corresponding subject/patient, logic/classification rules, and a “subject connectivity value” representative of a magnitude of a connection at a first time associated with first and second sub-processing regions of a subject associated with symptoms of an affective disorder and derived from an imaging scan/test; apply the classification rules to determine that the subject connectivity value exceeds a threshold for the connection to indicate that the subject is eligible for a cognitive-emotional training session; and identify, responsive to the cognitive-emotional training session, a subsequent subject connectivity value representing a magnitude measured at a second time of a connection between the first sub-processing region and the second sub-processing region of the nervous system of the subject (e.g., again, via reviewing resulting measurements on a screen or the like during/after the cognitive-emotional training session). These recitations, under their broadest reasonable interpretation, are similar to the concepts of collecting information, analyzing it and displaying certain results of the collection and analysis in Electric Power Group, LLC, v. Alstom (830 F.3d 1350, 119 USPQe2d 1739 (Fed. Cir. 2016)).
Furthermore, the Examiner submits that the foregoing underlined limitations constitute: “certain methods of organizing human activity” because they relate to managing personal behavior or relationships or interactions between people (e.g., social activities, teaching, and following rules or instructions). For instance, the recited steps of retrieving the keyed dataset, applying the rules to determine that the subject connectivity value exceeds a threshold indicative that a subject is eligible for a cognitive-emotional training session, and identifying a subsequent subject connectivity value are similar to a mental process that a neurologist should follow when testing a patient for nervous system malfunctions, In re Meyer, 688 F.2d 789, 791-93, 215 USPQ 193, 194-96 (CCPA 1982).
Accordingly, the claim recites at least one abstract idea.
Furthermore, dependent claims 2-8 and 12-18 further define the at least one abstract idea and thus fail to make it any less abstract as set forth below:
-Claims 2 and 12 call for determining that a second subject connectivity value of a second subject does not exceed the connectivity threshold value for the connection associated with the first and second sub-processing regions to indicate that the second subject is ineligible for a cognitive-emotional training session; and storing a second classification value to indicate that the second subject is ineligible for the cognitive-emotional training session, responsive to determining that the second subject connectivity value does not exceed the connectivity threshold value. These steps relate to “mental processes” and “certain methods of organizing human activity” similar to steps already discussed above.
-Claims 3 and 13 call for identifying a subsequent scan of the nervous system of the subject from which the subsequent subject connectivity value is derived subsequent to the presentation of the cognitive-emotional training session. These steps just further define the “mental processes” and “certain methods of organizing human activity” already discussed above.
-Claims 4, 5, 14, and 15 call for determining a difference between the subject connectivity value and the subsequent subject connectivity value for the first and second sub-processing regions of the subject subsequent to the cognitive-emotional training session. This step relates to “mental processes” and “certain methods of organizing human activity” similar to steps already discussed above.
-Claims 6-8 and 16-18 call for identifying the subject connectivity value representing an effective connectivity in the first and second sub-processing regions which relates to “mental processes” and “certain methods of organizing human activity” similar to steps already discussed above.
Subject Matter Eligibility Criteria - Alice/Mayo Test: Step 2A - Prong Two:
Regarding Prong Two of Step 2A of the Alice/Mayo test, it must be determined whether the claim as a whole integrates the abstract idea into a practical application. As noted at MPEP §2106.04(II)(A)(2), it must be determined whether any additional elements in the claim beyond the abstract idea integrate the exception into a practical application in a manner that imposes a meaningful limit on the judicial exception. The courts have indicated that additional elements such as merely using a computer to implement an abstract idea, adding insignificant extra solution activity, or generally linking use of a judicial exception to a particular technological environment or field of use do not integrate a judicial exception into a “practical application.” MPEP §2106.05(I)(A).
In the present case, the additional limitations beyond the above-noted at least one abstract idea recited in the claim are as follows (where the bolded portions are the “additional limitations” while the underlined portions continue to represent the at least one “abstract idea”):
A system, comprising:
a data processing system comprising one or more processors coupled with memory, the data processing system configured to (using computers or machinery as mere tools to perform the abstract idea as noted below, see MPEP § 2106.05(f)):
retrieve, from a hardware storage device maintaining one or more data structures storing (i) a plurality of keyed datasets, each of the plurality of keyed datasets including a respective key that represents a corresponding subject and (ii) executable logic defining classification rules (using computers or machinery as mere tools to perform the abstract idea as noted below, see MPEP § 2106.05(f)), a keyed dataset including a subject connectivity value derived from at least one of an imaging scan or test provided to the subject represented by a key in the keyed dataset, the subject connectivity value representing a magnitude measured at a first time of a connection between a first sub-processing region and a second sub-processing region of a nervous system of the subject associated with a symptom of an affective disorder;
execute the executable logic against the keyed dataset to (using computers or machinery as mere tools to perform the abstract idea as noted below, see MPEP § 2106.05(f)) determine that the subject connectivity value of the subject exceeds a connectivity threshold value for the connection between the first sub-processing region and the second sub-processing region to indicate that the subject is eligible for a cognitive-emotional training session;
store, on the hardware storage device, using the one or more data structures, at least an association between the key represented in the keyed dataset and a classification value to indicate that the subject is eligible for the cognitive-emotional training session (using computers or machinery as mere tools to perform the abstract idea as noted below, see MPEP § 2106.05(f); insignificant extra-solution activity (updating activity log) as noted below, see MPEP § 2106.05(g));
provide, responsive to the association between the key and the classification value, an instruction for presentation of the cognitive-emotional training session to the subject to induce activation of the first sub-processing region or the second sub-processing region of the nervous system of the subject to address the symptom of the affective disorder (generic instructions to “apply” the abstract idea, see MPEP § 2106.05(f); insignificant extra-solution activity, see MPEP § 2106.05(g));
identify, responsive to the cognitive-emotional training session, a subsequent subject connectivity value, the subsequent subject connectivity value representing a magnitude measured at a second time of a connection between the first sub-processing region and the second sub-processing region of the nervous system of the subject; and
store, on the hardware storage device, the subsequent subject connectivity value (using computers or machinery as mere tools to perform the abstract idea as noted below, see MPEP § 2106.05(f); insignificant extra-solution activity (updating activity log) as noted below, see MPEP § 2106.05(g)).
For the following reasons, the Examiner submits that the above-identified additional limitations, when considered as a whole with the limitations reciting the at least one abstract idea, do not integrate the above-noted at least one abstract idea into a practical application.
Regarding the additional limitations of the data processing system including processors with memory, the hardware storage device maintaining the data structures storing the keyed datasets, and the execution of the executable logic, the Examiner submits that these limitations amount to merely using a computer or other machinery as tools performing their typical functionality in conjunction with performing the above-noted at least one abstract idea (see MPEP § 2106.05(f)).
Regarding the additional limitations of providing, responsive to the classification value, an instruction for presentation of the cognitive-emotional training session to the subject to induce activation of the at least one sub-processing region of the nervous system of the subject to address the symptom of the affective disorder, the Examiner submits that this limitation amounts to a generic instruction to “apply” the abstract idea and/or merely reciting the idea of a solution or outcome without reciting details of how a solution to a problem is accomplished (see MPEP § 2106.05(f)). The Examiner also asserts that this limitation amounts to insignificant extra-solution activity because it is similar to performing clinical tests on an individual to obtain input for an equation (In re Grams, 888 F.2d 835, 839-40 (Fed. Cir. 1989)) and cutting hair after first determining the hair style (In Re Brown, 645 Fed. App'x 1014, 1016-17 (Fed. Cir. 2016)) (see MPEP § 2106.05(g)).
Regarding the additional limitation of storing the classification value indicating the subject is eligible for the CET session and storing the subsequent subject connectivity value, the Examiner submits that these additional limitations amount to merely using a computer or other machinery as tools performing their typical functionality in conjunction with performing the above-noted at least one abstract idea (see MPEP § 2106.05(f)) and merely add insignificant extra-solution activity (e.g., updating activity log) to the at least one abstract idea in a manner that does not meaningfully limit the at least one abstract idea (see MPEP § 2106.05(g)).
Thus, taken alone, the additional elements do not integrate the at least one abstract idea into a practical application.
Looking at the additional limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. For instance, there is no indication that the additional elements, when considered as a whole with the limitations reciting the at least one abstract idea, reflect an improvement in the functioning of a computer or an improvement to another technology or technical field, apply or use the above-noted judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition, implement/use the above-noted judicial exception with a particular machine or manufacture that is integral to the claim, effect a transformation or reduction of a particular article to a different state or thing, or apply or use the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole does not integrate the abstract idea into a practical application of the abstract idea. MPEP §2106.05(I)(A) and §2106.04(II)(A)(2).
For these reasons, representative independent claim 1 and analogous independent claim 11 do not recite additional elements that integrate the judicial exception into a practical application. Accordingly, representative independent claim 1 and analogous independent claim 11 are directed to at least one abstract idea.
The dependent claim limitations fail to integrate the abstract idea into a practical application as set forth below:
-Claims 2, 4, 5, 12, 14, and 15 call for storing a second/subsequent classification value to indicate that the CET is ineligible/effective/ineffective for the subject when the second value does not exceed the threshold, when the difference between the first and second values exceeds a second threshold, or when the difference does not exceed the threshold which amounts to merely using a computer or other machinery as tools performing their typical functionality in conjunction with performing the above-noted at least one abstract idea (see MPEP § 2106.05(f)) and merely adds insignificant extra-solution activity (e.g., updating activity log) to the at least one abstract idea in a manner that does not meaningfully limit the at least one abstract idea (see MPEP § 2106.05(g)).
-Claims 6-10 and 16-20 recite various different sub-processing region connectivities (e.g., between the DPFC and the AMG; between the dACC and the AMG; etc.), various different types of sub-processing regions (e.g., LCEN, RCEN, etc.), different types of affective disorders (e.g., MDD, PTSD, etc.), and different types of cognitive-emotional training sessions (e.g., EFMT, Emotional Stroop Test, etc.) and thus do no more than generally link use of the abstract idea to a particular technological environment or field of use without adding an inventive concept to the abstract idea (see MPEP § 2106.05(h)).
Thus, when the above additional limitations are considered as a whole along with the limitations directed to the at least one abstract idea, the at least one abstract idea is not integrated into a practical application. Therefore, the claims are directed to at least one abstract idea.
Subject Matter Eligibility Criteria - Alice/Mayo Test: Step 2B:
Regarding Step 2B of the Alice/Mayo test, representative independent claim 1 does not include additional elements (considered both individually and as an ordered combination) that are sufficient to amount to significantly more than the judicial exception for reasons the same as those discussed above with respect to determining that the claim does not integrate the abstract idea into a practical application.
Regarding the additional limitations of the data processing system including processors with memory, the hardware storage device maintaining the data structures storing the keyed datasets, and the execution of the executable logic, the Examiner submits that these limitations amount to merely using a computer or other machinery as tools performing their typical functionality in conjunction with performing the above-noted at least one abstract idea (see MPEP § 2106.05(f)).
Regarding the additional limitations of providing, responsive to the classification value, an instruction for presentation of the cognitive-emotional training session to the subject to induce activation of the at least one sub-processing region of the nervous system of the subject to address the symptom of the affective disorder, the Examiner submits that this limitation amounts to a generic instruction to “apply” the abstract idea and/or merely reciting the idea of a solution or outcome without reciting details of how a solution to a problem is accomplished (see MPEP § 2106.05(f)). The Examiner also asserts that this limitation amounts to insignificant extra-solution activity because it is similar to performing clinical tests on an individual to obtain input for an equation (In re Grams, 888 F.2d 835, 839-40 (Fed. Cir. 1989)) and cutting hair after first determining the hair style (In Re Brown, 645 Fed. App'x 1014, 1016-17 (Fed. Cir. 2016)) (see MPEP § 2106.05(g)). Furthermore, the Examiner has reevaluated such limitations and determined such limitations to not be unconventional as they merely consist of well-understood, routine, and conventional treatment approaches with affective disorders such as depression and the like as evidenced by NPL "Cognitive Behavioral Therapy Lowers Elevated Functional Connectivity in Depressed Adolescents" to Chattopadhyay at the second paragraph of the left column at page 217.
Regarding the additional limitation of storing the classification value indicating the subject is eligible for the CET session and storing the subsequent subject connectivity value which the Examiner submits amounts to merely using a computer or other machinery as tools performing their typical functionality in conjunction with performing the above-noted at least one abstract idea (see MPEP § 2106.05(f)) and merely adding insignificant extra-solution activity (e.g., updating activity log) to the at least one abstract idea in a manner that does not meaningfully limit the at least one abstract idea (see MPEP § 2106.05(g)), the Examiner has reevaluated such limitations and determined such limitations to not be unconventional as they merely consist of storing data in memory. See Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); See MPEP 2106.05(d)(II).
The dependent claims also do not include additional elements (considered both individually and as an ordered combination) that are sufficient to amount to significantly more than the judicial exception for the same reasons to those discussed above with respect to determining that the dependent claims do not integrate the at least one abstract idea into a practical application.
-Claims 2, 4, 5, 12, 14, and 15 call for storing a second/subsequent classification value to indicate that the CET is ineligible/effective/ineffective for the subject when the second value does not exceed the threshold, when the difference between the first and second values exceeds a second threshold, or when the difference does not exceed the threshold which amounts to merely using a computer or other machinery as tools performing their typical functionality in conjunction with performing the above-noted at least one abstract idea (see MPEP § 2106.05(f)) and merely adds insignificant extra-solution activity (e.g., updating activity log) to the at least one abstract idea in a manner that does not meaningfully limit the at least one abstract idea (see MPEP § 2106.05(g)). Furthermore, the Examiner has reevaluated such limitations and determined such limitations to not be unconventional as they merely consist of storing data in memory. See Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); See MPEP 2106.05(d)(II).
-Claims 6-10 and 16-20 recite various different sub-processing region connectivities (e.g., between the DPFC and the AMG; between the dACC and the AMG; etc.), various different types of sub-processing regions (e.g., LCEN, RCEN, etc.), different types of affective disorders (e.g., MDD, PTSD, etc.), and different types of cognitive-emotional training sessions (e.g., EFMT, Emotional Stroop Test, etc.) and thus do no more than generally link use of the abstract idea to a particular technological environment or field of use without adding an inventive concept to the abstract idea (see MPEP § 2106.05(h)).
Therefore, claims 1-20 are ineligible under 35 USC §101.
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 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 1-3, 9, 11-13, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent App. Pub. No. 2006/0217781 to John (“John”) in view of NPL “Functional Connectivity of the Subcallosal Cingulate Cortex And Differential Outcomes to Treatment With Cognitive-Behavioral Therapy or Antidepressant Medication for Major Depressive Disorder” to Dunlop et al. (“Dunlop”):
Regarding claim 1, John discloses a system, comprising:
a data processing system (brain modulation system (BMS) of [0037]) comprising one or more processors (processor 36 in Figure 4) coupled with memory ([0074]), the data processing system configured to:
retrieve, from a hardware storage device maintaining one or more data structures storing (i) a plurality of keyed datasets, each of the plurality of keyed datasets including a respective key that represents a corresponding subject and (ii) executable logic defining classification rules, a keyed dataset including a subject connectivity value derived from at least one of an imaging scan or test provided to the subject represented by a key in the keyed dataset, the subject connectivity value representing a magnitude measured at a first time of a connection between a first sub-processing region and a second sub-processing region of a nervous system of the subject ([0075] notes how sensed data (which represents a measure correlated with the function of a patient's brain regions (first and second sub-processing regions of a nervous system of the subject per [0038] and [0041]) and is derived from a neuroimaging scan/test provided to the subject per [0041], thus amounting to a "subject connectivity value") is stored in a database (which necessarily includes "data structures" stored in a storage device as the system is realized as a computer subsystem (also note how [0057], [0114] discloses how a database is a queryable information storage system and [0147] discloses how the stimulators can be controlled by a single computer system), where the "subject connectivity value" is necessarily associated with a key/identifier to distinguish the subject connectivity value of one patient from that of other patients in the storage device (such that there are a plurality of "keyed datasets" stored for a plurality of patients; see plurality of patients in [0079]); furthermore, [0075] discusses how the processor evaluates sensed data in the database using processing algorithms (executable logic) while [0091] discusses how the sensed data is evaluated to determine whether or not treatment meets a treatment criterion such that the logic includes some "classification rules" for making such determination and would be stored in the data structures of the storage device because that is how computers operate)) associated with a symptom of an affective disorder ([0038]-[0039]);
execute the executable logic against the keyed dataset to determine that the subject connectivity value of the subject exceeds a connectivity threshold value for the connection between the first sub-processing region and the second sub-processing region ([0091] discusses how evaluation of the sensed data (which includes the “subject connectivity value” between the two regions as noted above) includes determining whether the sensed data (which corresponds to the connection as noted above) is above/exceeds some specified value (“connectivity threshold value”) which corresponds to meeting a treatment criteria; furthermore, as the system is computer-implemented, then there is necessarily "executable logic" that is executed against the keyed subject connectivity value (the keyed dataset) to determine that the sensed data is above the specified value/threshold) to indicate that the subject is eligible for a [treatment] ([0075], [0091], [0114] discuss repeating/continuing treatment when the treatment criteria is met (when the threshold is exceeded); as a determination is made to perform the treatment after determining that the criteria/threshold is met, then the subject is “eligible” for the treatment);
store, on the hardware storage device, using the one or more data structures, at least an association between the key represented in the keyed dataset and a classification value to indicate that the subject is eligible for the [treatment] ([0075], 0091] discuss determining whether the sensed data (which includes the “subject connectivity value” as discussed above) is above the criteria value/threshold (meets the criteria) and then maintaining/continuing treatment (such that the patient is "eligible) and [0114] discusses how result/sensed data is stored in a database to serve as reference self-norm data; in order for the result/sensed data to serve as reference self-norm data, an indication as to whether the criteria was met or not met (“classification value”) would be stored along with (associated with) an indication/identifier/key for the respective patient (again, to distinguish the patient from other patients), which would collectively indicate that the patient/subject is eligible for the treatment);
provide, responsive to the association between the key and the classification value, an instruction for presentation of the [treatment] to the subject to induce activation of the first sub-processing region or the second sub-processing region of the nervous system of the subject to address the symptom of the affective disorder ([0075] and [0091] discuss how treatment can be controlled based on the treatment criteria/threshold being satisfied/exceeded; for instance, [0078] and [0114] disclose how the treatment can be maintained when the criteria/threshold being satisfied/exceeded; there is thus an instruction for “presenting” the treatment to the subject to modulate (induce activation of) the brain network/sub-processing region to address disorder symptoms per [0080] (which are affective disorders per [0039]);
identify, responsive to the [treatment], a subsequent subject connectivity value, the subsequent subject connectivity value representing a magnitude measured at a second time of a connection between the first sub-processing region and the second sub-processing region of the nervous system of the subject ([0098]-[0099] of John discuss how the treatment can be evaluated a number of times such as at regularly scheduled times; accordingly, at some time after the treatment, the treatment is evaluated which thus requires another (“second”) scan/test ([0041] of John) to provide further sensed data (measure/indication of the neuronal activity of a connection between first and second brain areas of the subject per [0038], [0041], [0075]) at a second time to determine if the treatment is effective; also, [0119] of John notes how treatments are guided by changes in analysis of imaging data; accordingly, after treatment, there is another scan and then the imaging is analyzed to guide treatment); and
store, on the hardware storage device, the subsequent subject connectivity value ([0114] discloses how result/sensed data ("subject connectivity value" per [0038], [0041], and [0075] as noted above) is stored in a database which is on the hardware storage device).
While the treatment in John is not limited to electrical and chemical neuromodulation (see “other type of neuromodulation” at the end of [0114]) and can include CBT ([0109], where CBT reads on the recited “cognitive-emotional training” because [0067] of present specification notes that cognitive-emotional training broadly encompasses any sort of “cognitive or emotion-oriented tasks” for inducing activation and modulating activation patterns within/between brain regions over time to induce symptom improvement in psychiatric conditions which is encompassed by CBT), John may be silent regarding the determination of the subject connectivity value exceeding the connectivity threshold specifically indicating that the subject is eligible for a cognitive-emotional training session and the provision of the instruction being for presenting the cognitive-emotional training session to the subject.
Nevertheless, Dunlop teaches (bottom of right column on page 534 to top of left column on page 535 and top of left column on page 540) that it was known in the healthcare informatics art that a functional connectivity value of the brain of a subject above a particular threshold indicates that CBT should be used on the subject (that the subject is “eligible” for the CBT, where CBT reads on the recited cognitive-emotional training as noted above). This arrangement advantageously improves the precision of treatment selection for individual depressed patients (right column on page 533).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have determined that the subject connectivity value of the subject exceeds a connectivity threshold value for the at least one sub-processing region to indicate that the subject is eligible for a cognitive-emotional training session and to provided, responsive to the classification value, an instruction for presentation of the cognitive-emotional training session to the subject to induce activation of the at least one sub-processing region of the nervous system of the subject to address the symptom of the affective disorder in the system of John as taught by Dunlop to advantageously improve the precision of treatment selection for individual depressed patients. A person of ordinary skill in the art would have been motivated to combine the prior art to achieve the claimed invention and there would have been a reasonable expectation of success in doing so." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). Furthermore, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. Id.
Regarding claim 2, the John/Dunlop combination discloses the system of claim 1, further including wherein the data processing system is further configured to:
determine that a second subject connectivity value of a second subject does not exceed the connectivity threshold value for the connection between the first sub-processing region and the second sub-processing region ([0091] of John discusses how evaluation of the sensed data (which includes the “subject connectivity value” as noted above) includes determining whether the sensed data (which corresponds to the connection associated with the “first sub-processing region” and the “second sub-processing region” as noted above) is below some specified value (“connectivity threshold value”) which corresponds to not meeting a treatment criteria while [0079]-[0080] discloses how the system can treat multiple patients such that a second patient (second subject) would have second sensed data (second subject connectivity value), wherein not exceeding the connectivity threshold value indicates that the second subject is ineligible for a cognitive-emotional training session ([0075], [0091], [0114] discuss repeating/maintaining the treatment (cognitive-emotional training per the combination with Dunlop) when the treatment criteria is met (when the threshold is exceeded) or to adjust/change the treatment when the treatment criteria is not met (when the threshold is not exceeded); if a determination is made to perform the treatment/cognitive-emotional training after determining that the criteria/threshold is met, then the subject is “eligible” for the cognitive-emotional training; if a determination is made to adjust/change the treatment/cognitive-emotional training after determining that the criteria/threshold is not met, then the subject is “ineligible” for the cognitive-emotional training; similar to as discussed previously, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have determined that the subject connectivity value of the subject exceeds a connectivity threshold value for the at least one sub-processing region to indicate that the subject is eligible for a cognitive-emotional training session and to provided, responsive to the classification value, an instruction for presentation of the cognitive-emotional training session to the subject to induce activation of the at least one sub-processing region of the nervous system of the subject to address the symptom of the affective disorder in the system of John as taught by Dunlop to advantageously improve the precision of treatment selection for individual depressed patients. A person of ordinary skill in the art would have been motivated to combine the prior art to achieve the claimed invention and there would have been a reasonable expectation of success in doing so." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). Furthermore, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. Id.); and
store, on the hardware storage device, a second classification value to indicate that the second subject is ineligible for the cognitive-emotional training session, responsive to determining that the second subject connectivity value does not exceed the connectivity threshold value ([0091] of John discusses determining whether the sensed data (which includes the “subject connectivity value” as discussed above) is above or below the criteria value/threshold and [0114] of John discusses how result/sensed data is stored in a database to serve as reference self-norm data; in order for the result/sensed data to serve as reference self-norm data, an indication as to whether the criteria was met or not met for the second subject/patient (“second classification value”) would be stored along with (associated with) the corresponding result/sensed data (“second connectivity value”); in the case of the sensed data (second connectivity value) not exceeding the criteria/threshold, the classification thereby indicates that the subject is ineligible for the previous treatment (cognitive-behavioral therapy per the combination with Dunlop) and must be adjusted/modified to a new treatment).
Regarding claim 3, the John/Dunlop combination discloses the system of claim 1, further including wherein the data processing system is further configured to:
identify a subsequent scan of the nervous system of the subject subsequent to the presentation of the cognitive-emotional training session ([0098]-[0099] of John discuss how the treatment can be evaluated a number of times such as at regularly scheduled times; accordingly, at some time after the treatment (cognitive-emotional training per the combination with Dunlop), the treatment is evaluated which thus requires another (“second”) scan/test ([0041] of John) to provide further sensed data to determine if the treatment is effective; also, [0119] of John notes how treatments are guided by changes in analysis of imaging data; accordingly, after treatment (after the cognitive-emotional training per the combination with Dunlop), there is another scan and then the imaging is analyzed to guide treatment); and
wherein the subsequent subject connectivity value is derived from the subsequent scan, the subsequent subject connectivity value representing the magnitude of the connection associated with at least one sub-processing region of a nervous system of the subject subsequent to the cognitive-emotional training session (as noted previously, [0075] discloses sensed data which represents a measure/indication of the neuronal activity of a connection between first and second brain areas of the subject per [0038] and [0041] of John which is derived from the second scan/test provided to the subject after the treatment (cognitive-emotional training per the combination with Dunlop) per [0041] and as noted above).
Regarding claim 9, the John/Dunlop combination discloses the system of claim 1, further including wherein the affective disorder of the subject further comprises at least one of a major depressive disorder (MDD), a bipolar disorder, a post-traumatic stress disorder (PTSD), a general anxiety disorder, a social phobia, an obsessive compulsive disorder, a treatment resistant depression, or a borderline personality disorder ([0117] of John discloses MDD and bipolar disorder).
Claim 11-13 and 19 are rejected in view of the John/Dunlop combination as respectively discussed above in relation to claims 1-3 and 9.
Claims 4, 5, 14, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent App. Pub. No. 2006/0217781 to John (“John”) in view of NPL “Functional Connectivity of the Subcallosal Cingulate Cortex And Differential Outcomes to Treatment With Cognitive-Behavioral Therapy or Antidepressant Medication for Major Depressive Disorder” to Dunlop et al. (“Dunlop”), and further in view of U.S. Patent App. Pub. No. 2018/0310854 to Geva et al. (“Geva”):
Regarding claim 4, the John/Dunlop combination discloses the system of claim 1, but appears to be silent regarding wherein the data processing system is further configured to:
determine a difference between the subject connectivity value and the subsequent subject connectivity value for the first sub-processing region and the second sub-processing region of the subject subsequent to the cognitive-emotional training session; and
store, on the hardware storage device, a subsequent classification value to indicate that the cognitive-emotional training session is effective for the subject, responsive to the difference exceeding a second threshold value.
Nevertheless, Geva teaches ([0107]) that it was known in the healthcare informatics art to determine a difference between cortical potentials in a subject’s brain before and after a treatment and to determine that the treatment is effective when the difference is greater than a threshold to advantageously administer treatments that may be effective in reducing or eliminating the symptoms of the subject’s condition.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have determined a difference between the subject connectivity value and a subsequent subject connectivity value for the first sub-processing region and the second sub-processing region of the subject subsequent to the treatment (the cognitive-emotional training session per the combination with Dunlop) and determine that the treatment/cognitive-emotional training session is effective for the patient when the difference exceeds a second threshold value in the system of the John/Dunlop combination similar to as taught by Geva to advantageously administer treatments that may be effective in reducing or eliminating the symptoms of the subject’s condition. A person of ordinary skill in the art would have been motivated to combine the prior art to achieve the claimed invention and there would have been a reasonable expectation of success in doing so." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). Furthermore, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. Id.
As noted previously, [0114] of John already discloses how the result/sensed data (connectivity value(s)) is stored in a database to serve as reference self-norm data. In order for the result/sensed data to serve as reference self-norm data, an indication (“subsequent classification value”) that the treatment was effective would be stored (which is responsive to the difference exceeding the second threshold value per the above combination with Geva)).
Regarding claim 5, the John/Dunlop combination discloses the system of claim 1, but appears to be silent regarding wherein the data processing system is further configured to:
determine a difference between the subject connectivity value and the subsequent subject connectivity value for the first sub-processing region and the second sub-processing region of the subject subsequent to the cognitive-emotional training session; and
store, on the hardware storage device, a subsequent classification value to indicate that the cognitive-emotional training session is ineffective for the subject, responsive to the difference not exceeding a second threshold value.
Nevertheless, Geva teaches ([0107]) that it was known in the healthcare informatics art to determine a difference between cortical potentials in a subject’s brain before and after a treatment and to determine that the treatment is effective when the difference is greater than a threshold to advantageously administer treatments that may be effective in reducing or eliminating the symptoms of the subject’s condition. Accordingly, one of ordinary skill in the art would determine the treatment is ineffective when the difference is not greater than the threshold.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have determined a difference between the subject connectivity value and a subsequent subject connectivity value for the first sub-processing region and the second sub-processing region of the subject subsequent to the treatment (the cognitive-emotional training session per [0109] of John) and determine that the treatment/cognitive-emotional training session is ineffective for the patient when the difference does not exceed the second threshold value in the system of John similar to as taught by Geva to advantageously administer treatments that may be effective in reducing or eliminating the symptoms of the subject’s condition. A person of ordinary skill in the art would have been motivated to combine the prior art to achieve the claimed invention and there would have been a reasonable expectation of success in doing so." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). Furthermore, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. Id.
As noted previously, [0114] of John already discloses how the result/sensed data (connective value(s)) is stored in a database to serve as reference self-norm data. In order for the result/sensed data to serve as reference self-norm data, an indication (“subsequent classification value”) that the treatment was ineffective would be stored (which is responsive to the difference not exceeding the second threshold value per the above combination with Geva)).
Claims 14 and 15 are rejected in view of the John/Dunlop/Geva combination as respectively discussed above in relation to claims 4 and 5.
Claims 6 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent App. Pub. No. 2006/0217781 to John (“John”) in view of NPL “Functional Connectivity of the Subcallosal Cingulate Cortex And Differential Outcomes to Treatment With Cognitive-Behavioral Therapy or Antidepressant Medication for Major Depressive Disorder” to Dunlop et al. (“Dunlop”), and further in view of NPL “Brain connectivity changes occurring following cognitive behavioural therapy for psychosis predict long-term recovery” to Mason et al. (“Mason”):
Regarding claim 6, the John/Dunlop combination discloses the system of claim 1, further including wherein the data processing system is further configured to identify the subject connectivity value representing an effective connectivity in the first sub-processing region and the second sub-processing region ([0008] of John discusses how the sensed data (subject connectivity value) corresponds to interactions between different brain areas (effective connectivity)), …
However, the John/Dunlop combination appears to be silent regarding wherein the first sub-processing region and the second sub-processing region comprise at least one of a dorsolateral prefrontal cortex (DPFC), an amygdala (AMG), or an anterior cingulate cortex (dACC).
Nevertheless, Mason teaches (right column of page 1) that it was known in the healthcare informatics art that increases in connectivity between the dorsolateral prefrontal cortex (DPFC) and amygdala (AMG)(which amounts to “effective connectivity” because it can represent an influence that one brain region has on another via the connection) following CBTp can indicate an increased ability to cognitively regulate negative affect.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the first sub-processing region and the second sub-processing region to include the DPFC and the AMG, and for the subject connectivity value to represent an effective connectivity between the DPFC and the AMG in the system of the John/Dunlop combination as taught by Mason to advantageously provide an indication of whether CBT can provide an increased ability of a patient to cognitively regulate negative affect. A person of ordinary skill in the art would have been motivated to combine the prior art to achieve the claimed invention and there would have been a reasonable expectation of success in doing so." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). Furthermore, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. Id.
Claim 16 is rejected in view of the John/Dunlop/Mason combination as discussed above in relation to claim 6.
Claims 7 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent App. Pub. No. 2006/0217781 to John (“John”) in view of NPL “Functional Connectivity of the Subcallosal Cingulate Cortex And Differential Outcomes to Treatment With Cognitive-Behavioral Therapy or Antidepressant Medication for Major Depressive Disorder” to Dunlop et al. (“Dunlop”), and further in view of NPL “Resting-state functional connectivity in major depressive disorder: A review” to Mulders et al. (“Mulders”):
Regarding claim 7, the John/Dunlop combination discloses the system of claim 1, but appears to be silent regarding wherein the data processing system is further configured to identify the subject connectivity value representing a functional connectivity within the first sub-processing region and the second sub-processing region, and wherein the first sub-processing region and the second sub-processing region comprise at least one of a default mode resting state network (DMN) or a salience resting state network (SAL).
Nevertheless, Mulders teaches (Figure 1 and sections 2.1, 5.5, and 6) that it was known in the healthcare informatics art to utilize functional connectivity within a resting state default mode network (DMN) of a patient to guide treatment recommendations for the patient.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to identify the subject connectivity value representing a functional connectivity within the first sub-processing region and the second sub-processing region and for the first sub-processing region and the second sub-processing region to include the DMN in the system of the John/Dunlop combination as taught by Mulders to advantageously guide treatment recommendations for the patient. A person of ordinary skill in the art would have been motivated to combine the prior art to achieve the claimed invention and there would have been a reasonable expectation of success in doing so." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). Furthermore, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. Id.
Claim 17 is rejected in view of the John/Dunlop/Mulders combination as discussed above in relation to claim 7.
Claims 8 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent App. Pub. No. 2006/0217781 to John (“John”) in view of NPL “Functional Connectivity of the Subcallosal Cingulate Cortex And Differential Outcomes to Treatment With Cognitive-Behavioral Therapy or Antidepressant Medication for Major Depressive Disorder” to Dunlop et al. (“Dunlop”), and further in view of NPL “Imbalance between Left and Right Dorsolateral Prefrontal Cortex in Major Depression Is Linked to Negative Emotional Judgment: An fMRI Study in Severe Major Depressive Disorder” to Grimm et al. (“Grimm”):
Regarding claim 8, the John/Dunlop combination discloses the system of claim 1, but appears to be silent regarding wherein the data processing system is further configured to identify the subject connectivity value representing an integration between a pair of sub-processing regions, and wherein the pair of sub-processing regions comprises at least one of: a left central executive network (LCEN) and a right central executive network (RCEN); a dorsal default mode resting state network (dDMN) and a ventral default mode resting state network (vDMN); the LCEN and the vDMN; and the LCEN and SAL.
Nevertheless, Grimm teaches (end of page 375 to beginning of page 376) that it was known in the healthcare informatics art that measuring imbalance between left and right dorsolateral prefrontal cortex (which, as evidenced by NPL “Effects of Cognitive Training on Resting-State Functional Connectivity of Default Mode, Salience, and Central Executive Networks” to Cao et al. (“Cao”)(see bottom of left column on page 2), are part of the central executive network) can guide treatment approaches for patients with major depressive disorder.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to identify the subject connectivity value representing an integration/connection between a pair of sub-processing regions including an LCEN and an RCEN in the system of the John/Dunlop combination as taught by Grimm to advantageously guide treatment approaches for patients with major depressive disorder. A person of ordinary skill in the art would have been motivated to combine the prior art to achieve the claimed invention and there would have been a reasonable expectation of success in doing so." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). Furthermore, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. Id.
Claim 18 is rejected in view of the John/Dunlop/Grimm combination as discussed above in relation to claim 8.
Claims 10 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent App. Pub. No. 2006/0217781 to John (“John”) in view of NPL “Functional Connectivity of the Subcallosal Cingulate Cortex And Differential Outcomes to Treatment With Cognitive-Behavioral Therapy or Antidepressant Medication for Major Depressive Disorder” to Dunlop et al. (“Dunlop”), and further in view of U.S. Patent No. 9,308,445 to Merzenich et al. (“Merzenich”):
Regarding claim 10, the John/Dunlop combination discloses the system of claim 1, but appears to be silent regarding wherein the cognitive-emotional training session comprises at least one of an Emotional Faces Memory Task (EFMT), a Wisconsin Card Sorting Test, an Emotional Stroop Test, an Iowa Gambling Task, a Dot-probe task, a Face perception task, or a delay discounting task.
Nevertheless, Merzenich teaches (Abstract) that it was known in the healthcare informatics art to deliver training games such as an emotional stroop test and facial affect recognition training (37:57-38:6) to patients with disorders such as MDD and the like to advantageously improve emotional self-monitoring abilities, balances distorted responses to emotionally negative or disturbing stimuli, and re-normalizes distorted cognitive brain system patterns of response, thereby contributing to a more complete, more effective and more enduring brain changes to normalize the brain function.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the cognitive-emotional training session of the John/Dunlop combination to include an emotional stroop test or a face perception task as taught by Merzenich to advantageously improve emotional self-monitoring abilities, balances distorted responses to emotionally negative or disturbing stimuli, and re-normalizes distorted cognitive brain system patterns of response, thereby contributing to a more complete, more effective and more enduring brain changes to normalize the brain function. A person of ordinary skill in the art would have been motivated to combine the prior art to achieve the claimed invention and there would have been a reasonable expectation of success in doing so." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). Furthermore, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. Id.
Claim 20 is rejected in view of the John/Dunlop/Merzenich combination as discussed above in relation to claim 10.
Conclusion
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/JONATHON A. SZUMNY/Primary Examiner, Art Unit 3686