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 (“RCE”), 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 June 29, 2026, has been entered.
Status of Claims
Claims 1-20 were previously pending and subject to a Final Office Action having a notification date of March 31, 2026 (“Final Office Action”). Following the Final Office Action, Applicant filed the RCE and an amendment on June 29, 2026 (“Amendment”), amending claims 1, 3-5, 11, and 13-15.
The present non-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
In relation to the claim rejections under 35 USC 101 set forth in the Final Office Action, these rejections are now withdrawn when currently pending claims 1-20 are considered in view of the 2019 Revised Patent Subject Matter Eligibility Guidance (which collectively includes the guidance in the January 7, 2019 Federal Register notice and the October 2019 update issued by the USPTO as incorporated into the MPEP) and Applicant’s remarks in the Amendment.
Specifically, while the independent claims include limitations that recite at least one mental process abstract idea (e.g., comparing the subject connectivity value to the connectivity threshold value to classify the subject as eligible for a cognitive-emotional training (CET) session or ineligible for a CET session, they also recite a treatment step (e.g., providing in instruction for presentation of the CET session to the subject to induce activation of the first or second sub-processing regions of the nervous system to address the affective disorder symptoms responsive to the stored association between the identifier and eligibility classification) that is particular and integrates the mental analysis steps into a practical application, has more than a nominal or insignificant relationship to the abstract idea, and is not merely extra-solution activity or a field of use. MPEP 2106.04(d)(2).
Response to Applicant’s Arguments Regarding Claim Rejections Under 35 USC §103
On pages 14-15 of the Amendment, Applicant takes the position that John and Dunlop do not disclose indicating/classifying a subject as “eligible” or “ineligible” for CBT. The Examiner disagrees.
Initially, [0075], [0091], [0114] of John already discloses maintaining a treatment protocol when sensed data meets a treatment criteria (which corresponds to the subject being “eligible” for an original treatment protocol) and changing the treatment protocol to a different protocol when the sensed data does not meets the treatment criteria (which corresponds to the subject being “ineligible” for the original treatment protocol). The Examiner is interpreting a subject being “eligible” for a treatment as being a “good candidate” for the treatment per the bottom of Applicant’s [0092]. Furthermore, 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 to implement CBT (where CBT reads on the recited cognitive-emotional training) when a functional connectivity value of the brain of a subject with depression (affective disorder) is above a threshold value (where such a subject is “eligible” for the CBT because he or she is a “good candidate” for such CBT). Alternatively, when the connectivity value of the subject is below the threshold (such as below a lower second threshold which is below the first threshold), then the patient is not a “good candidate” for CBT because medication is prescribed instead of CBT (i.e., the patient is “ineligible” for the CBT). 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 for the determination of the subject connectivity value exceeding the connectivity threshold to specifically indicate 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 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.
Applicant then takes the position that Dunlop is completely silent with respect to "store an association between an identifier for the subject and a first classification value corresponding to the first classification," and "provide, responsive to the association between the identifier for the subject and the first classification value corresponding to the first classification indicating that the subject is eligible, an instruction for presentation of the cognitive-emotional training session to the subject," as recited in amended claim 1. However, [0075], [0091], [0114] of John discusses maintaining a treatment protocol when the sensed data meets the treatment criteria, such as being above (exceeding) a specified value/threshold (the subject is “eligible” for the original treatment protocol); [0075] of John discloses how the database stores sensed data values and stimulation protocols; [0079] of John discusses how profiles of patients that do or do not respond to treatment can be analyzed; and [0114] of John discusses how result/sensed data is stored in a database to serve as reference self-norm data. Therefore, 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) some identifier for the respective patient (to distinguish the patient from the other patients), which would collectively indicate that the patient/subject is eligible for the treatment (which is CBT per the combination with Dunlop).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 6-8, 11, and 16-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4-6, and 11-15 of U.S. Patent No. 11,862,338 (“the ‘338 Patent”) in view of U.S. Patent App. Pub. No. 2006/0217781 to John (“John”). Although the claims at issue are not identical, they are not patentably distinct from each other:
Present Independent Claim 1
Independent Claim 1 of ‘338 Patent (underlined limitations correspond to limitations in present independent claim 1)
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 subject connectivity value for a subject suffering from an affective disorder, the subject connectivity value derived from at least one of an imaging scan or test provided to the subject, 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, the first sub-processing region and the second sub-processing region associated with a symptom of the affective disorder;
compare the subject connectivity value of the subject to a connectivity threshold value for the connection between the first sub-processing region and the second sub-processing region to classify the subject as one of (i) a first classification to indicate that the subject is eligible for a cognitive-emotional training session and (ii) a second classification to indicate that the subject is ineligible for the cognitive-emotional training session;
responsive to determining that the subject connectivity value of the subject exceeds the connectivity threshold value for the connection between the first sub-processing region and the second sub-processing region, store, on the hardware storage device, an association between an identifier for the subject and a first classification value corresponding to the first classification to indicate that the subject suffering from the affective disorder is eligible for the cognitive-emotional training session; and
provide, responsive to the association between the identifier for the subject and the first classification value corresponding to the first classification indicating that the subject is eligible, 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.
A system, comprising:
a data processing system comprising one or more processors, configured to:
maintain, on a hardware storage device, one or more data structures and executable logic defining classification rules, each data structure storing a plurality of keyed datasets, each of the plurality of keyed datasets including a respective key that represents a corresponding subject;
retrieve, from the at least one of the one or more data structures on the hardware storage device, a keyed dataset for a subject suffering from an affective disorder, the keyed dataset including a subject connectivity value derived from at least one of a scan or test provided to the subject represented by a key included in the retrieved keyed dataset, the subject connectivity value representing a magnitude of a connection associated with at least one sub-processing region of a nervous system of the subject in response to performing a cognitive-emotional training session at a first time, the at least one sub-processing region associated with a symptom of the affective disorder;
execute the executable logic against the keyed dataset to apply the classification rules to compare the subject connectivity value of the subject to a connectivity threshold value for the at least one sub-processing region to classify the subject as one of (i) a first classification to indicate that the subject is eligible for the cognitive-emotional training session at a second time and (ii) a second classification to indicate that the subject is ineligible for the cognitive-emotional training session at the second time;
determine that the subject connectivity value of the subject exceeds the connectivity threshold value for the at least one sub-processing region;
store, using the one or more data structures, an association between the key represented in the keyed dataset and a first classification value corresponding to the first classification to indicate that the subject suffering from the affective disorder is eligible for the cognitive-emotional training session at the second time, responsive to determining that the subject connectivity value exceeds the connectivity threshold value; and
provide, responsive to the association between the key and the first classification value corresponding to the first classification indicating that the subject is eligible, an instruction for presentation of the cognitive-emotional training session to the subject at the second time, 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 relation to present claim 1 reciting --the subject connectivity value representing a magnitude measured at a first time between a first sub-processing region and a second sub-processing region--, the Examiner notes that claim 1 of the ‘338 Patent recites “the subject connectivity value representing a magnitude of a connection associated with at least one sub-processing region of a nervous system of the subject …” which would necessarily include at least two sub-processing regions (e.g., first and second sub-processing regions) for such connection.
In relation to claim 1 reciting how the “scan or test provided to a subject” is --an imaging scan or test provided to a subject--, John discloses that it was known in the healthcare informatics art to retrieve a subject connectivity value ([0075] discloses sensed data (subject connectivity value) 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]) derived from at least one of an imaging scan or test provided to the subject (the sensed data is derived from a functional neuroimaging scan/test provided to the subject per [0041]), evaluate the sensed data/subject connectivity value to determine if it is above/exceeds some specified value (“connectivity threshold value”) which corresponds to meeting a treatment criteria ([0091]), and provide treatment (of an affective disorder per [0039]) based on the criteria/threshold being satisfied/exceeded ([0075], [0091]). Generating sensed data (subject connectivity values) based on imaging scans/tests provided to a subject provides information about an amount or changes in amount of brain characteristics including blood flow, neurotransmitter levels, metabolism, and electrophysiological activity of a subject that can advantageously be used to determine how to guide treatment to the subject to improve brain disorder treatment ([0041], [0081]).
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 scan or test in claim 1 of the ‘338 Patent to be an imaging scan or test as taught by John to provide information about an amount or changes in amount of brain characteristics including blood flow, neurotransmitter levels, metabolism, and electrophysiological activity of a subject that can advantageously be used to determine how to guide treatment to the subject to improve brain disorder treatment. 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.
The remaining claims are rejected as follows:
Present Claims
‘338 Patent Claims (in view of John)
6
2
7
4, 5
8
6
11
11
16
12
17
13, 14
18
15
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 a subject connectivity value for a subject suffering from an affective disorder, the subject connectivity value derived from at least one of an imaging scan or test provided to the subject, 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 ([0038]-[0041] discusses how sensed data (subject connectivity value) representing a measure (at some first time) correlated with the function of brain regions (first and second sub-processing regions of a nervous system) of a subject suffering from an affective disorder is derived from a neuroimaging scan/test provided to the subject; also, [0075], [0092] discuss how sensed data can be from two nodes of a network (first and second sub-processing regions) and how sensed data can be stored in a database (implemented in a queryable information storage system/hardware storage device per [0057]));
compare the subject connectivity value of the subject to a connectivity threshold value for the connection between the first sub-processing region and the second sub-processing region ([0075] discusses controlling treatment according to whether or not the sensed data (which includes the “subject connectivity value” between the two regions as noted above) meets treatment criteria; for instance, [0091] discusses how evaluation of the sensed data includes determining whether it is above or below some specified value (“connectivity threshold value”)) to classify the subject as one of (i) a first classification to indicate that the subject is eligible for a [treatment] ([0075], [0091], [0114] discuss maintaining a treatment protocol when the sensed data meets the treatment criteria (the subject is “eligible” for the original treatment protocol or in other words is a “good candidate” for such continued treatment protocol per the end of Applicant’s [0092]) and (ii) a second classification to indicate that the subject is ineligible for the [treatment] ([0075], [0091], [0114] discuss changing the treatment protocol to a different protocol when the sensed data does not meets the treatment criteria (the subject is “ineligible” for the original treatment protocol);
responsive to determining that the subject connectivity value of the subject exceeds the connectivity threshold value for the connection between the first sub-processing region and the second sub-processing region, store, on the hardware storage device, an association between an identifier for the subject and a first classification value corresponding to the first classification to indicate that the subject suffering from the affective disorder is eligible for the [treatment] ([0075], [0091], [0114] discuss maintaining a treatment protocol when the sensed data meets the treatment criteria, such as being above (exceeding) a specified value/threshold (the subject is “eligible” for the original treatment protocol); also, [0075] discloses how the database stores sensed data values and stimulation protocols, [0079] discusses how profiles of patients that do or do not respond to treatment can be analyzed, 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) some identifier for the respective patient (to distinguish the patient from the other patients), which would collectively indicate that the patient/subject is eligible for the treatment)); and
provide, responsive to the association between the identifier for the subject and the first classification value corresponding to the first classification indicating that the subject is eligible, 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]);
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 to implement CBT (where CBT reads on the recited cognitive-emotional training) when a functional connectivity value of the brain of a subject with depression (affective disorder) is above a threshold value (where such a subject is “eligible” for the CBT because he or she is a “good candidate” for such CBT). Alternatively, when the connectivity value of the subject is below the threshold (such as below a lower second threshold which is below the first threshold), then the patient is not a “good candidate” for CBT because medication is prescribed instead of CBT (i.e., the patient is “ineligible” for the CBT). 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 for the determination of the subject connectivity value exceeding the connectivity threshold to specifically indicate 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 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 a 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 a 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 determine 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 a 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
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