DETAILED ACTION
Claims 51-70 are hereby the present claims under consideration.
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 .
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
In particular, the abstract is written as a claim and is not considered to be narrative and avoid legal phraseology.
Examiner’s Note: The limitation “a neurofeedback (NF) treatment” is given its broadest reasonable interpretation in light of the specification. In particular, the NF treatment is interpreted as a presentation of an image or video. The NF treatment is not considered to require the recording of biomarkers alongside the presentation of the image or video and is further not considered to require any adaptation of the treatment based on the recorded biomarkers. This interpretation is consistent with paragraphs 0224-0226 of the specification which set forth that the NF treatment includes a presentation of an image or video “selected to increase an activity …”and that “some embodiments” may include the measuring or EEG signals or other biomarkers and further that “some embodiments” may include providing the patient feedback by modifying the presented interface. Thus the BRI of the treatment is the audio/visual display alone.
Claim Objections
Claims 51-67 and 69 are objected to because of the following informalities:
Claim 51 line 4 it appears that “a specific sub-population of patients” should read “a specific sub-population of the PTSD patients”
Claims 51 lines 5-6 it appears that “said specific sub-population of patients” should read “said selected specific sub-population” to be more consistent with the rest of the language used in the claims.
Claim 51 line 8 it appears that “DSM-5” should read “Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)”
Claims 52-67 it appears that “A method according to claim” should read “The method according to claim”
Claims 53, 56, 59, 62, and 65 it appears that “PCL-5” should read “PTSD Checklist for DSM-5 (PCL-5)” as the meaning of PCL-5 has not yet been established in the dependency of these claims.
Claims 57, 60, 63, and 66 it appears that “PHQ-9” should read “Patient Health Questionnaire-9 (PHQ-9)” as the meaning of PHQ-9 has not yet been established in the dependency of these claims.
Claim 69 it appears that “A system according to claim” should read “The system according to claim”
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 52-60, 62-66, and 68-70 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 52-60, and 62-66 each recite limitations drawn towards the achieving step of claim 51. It is unclear if the recited achieving limitations of the dependent claims are required to be met in addition to or in place of the achieving result of claim 51. In particular, claims 55, 58, and 64 each recite an achievement of a reduction in the CAPS-5 scale that is different from the achievement set forth in claim 51. It is unclear if the required achievement for the subgroups presented in 55, 58, and 64 is meant to replace the achievement requirement set forth in claim 51 since they recite different score criteria for the same scoring method (CAPS-5). While the rest of the indicated claims are directed towards different scoring methods, it is unclear if the recited results in these scoring methods must be achieved in addition to the CAPS-5 scoring criteria set forth in their respective dependencies or if the scoring method set forth in the remaining claims may be achieved in lieu of the CAPS-5 scoring requirement set forth in their respective dependencies. For the purposes of this examination, the limitations are interpreted as the scoring requirement set forth in each dependent claim as being in place of the scoring requirement of the claims from which they depend.
Claims 68 recites “a control circuitry, wherein said control circuitry is configured to deliver said NF treatment to said PTSD patient” but it is unclear how the control circuitry itself delivers the NF treatment. It would seem that the control circuitry would control some form of output device in order to deliver the treatment rather than delivering the treatment itself. For the purposes of this examination, the limitation will be interpreted as the control circuitry controlling an output device to deliver the NF treatment.
Claim 69 is rejected by virtue of its dependency of claim 68.
Claim 69 recites “process the assessment results” but it is unclear if this limitation is intended to convey that the system performs the assessment or receives the assessment results from an outside source. In particular, claim 68 indicates that the system generates an indication to perform the assessment in a given time period but does not indicate that the system performs the assessment itself. Claim 69 then indicates that the assessment results are processes but it is unclear from where these results are derived. For the purposes of this examination, the limitation is interpreted as the system performing the assessment.
Claim 70 recites “wherein said dynamic audio-visual interface is configured to be modified during said treatment to achieve a reduction of at least 6 points in a Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) in said PTSD patient after a time period of between 8 weeks and 12 weeks of said treatment, or up to 3 months from completion of said treatment” but it is unclear what the modification to the audio-visual interface comprises since such a modification results in at least a 6 point reduction in a CAPS-5 score. It is unclear how this modification is capable of achieving the claimed reduction for every patient with PTSD and what such a modification which accomplishes this reduction entails. For the purposes of this examination, the limitation is interpreted as an interface which is modified as part of a treatment for PTSD in an attempt to lower CAPS-5 scores.
Claim Rejections - 35 USC § 112(a)
Claim 70 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 70 recites “wherein said dynamic audio-visual interface is configured to be modified during said treatment to achieve a reduction of at least 6 points …” but the specification does not recite the particular algorithm for performing the claimed function. In particular, MPEP 2161.01(i) recites the claims may lack written description when the claims define the invention in functional language specifying a desired result but the specification does not sufficiently describe how the function is performed or the result is achieved. For software, this can occur when the algorithm or steps/procedure for performing the computer function are not explained at all or are notexplained in sufficient detail (simply restating the function recited in the claim is not necessarilysufficient). In other words, the algorithm or steps/procedure taken to perform the function mustbe described with sufficient detail so that one of ordinary skill in the art would understand howthe inventor intended the function to be performed. See MPEP §§ 2163.02 and 2181, subsectionIV. In the instant case, the specification does not detail specifically how the audio-visual interface is modified to achieve the claimed result. Applicant’s specification generally describes the desired function of the algorithm and recites that modifications to the treatment can be made according to assessment results and/or feedback measured from the patient and that modifications may include extending the treatment or changing the treatment in paragraphs 0220, 0222, 0229-0230, 0265, and 0303. The specification does not describe the specific changes made to the treatment images/sounds, or the audio-visual interface, that achieve the claimed effect. Furthermore, while WO2012104853A2 and WO2020121299A1 are not considered to be successfully incorporated by reference as described above, neither of these references are considered to provide the particular algorithm for modifying the neurofeedback treatment to achieve a reduction of at least 6 points in a CPAS-5 scale. While these references do detail various methods for modifying the NF treatment, according to biofeedback they fail to describe a particular method of modifying an audio-visual interface to achieve a reduction of at least 6 points in a CAPS-5 scale after a time period of between 8 and 12 weeks of treatment. The specific modifications performed to the interface that result in the claimed achievement are not seemingly described.
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 68-69 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Claims 68-69 are directed to a system for delivering a neurofeedback treatment using a computational algorithm, which is an abstract idea. Claims 68-69 do not include additional elements that integrate the exception into a practical application or that are sufficient to amount to significantly more than the judicial exception for the reasons provided below which are in line with the 2014 Interim Guidance on Patent Subject Matter Eligibility (Federal Register, Vol. 79, No. 241, p 74618, December 16, 2014), the July 2015 Update on Subject Matter Eligibility (Federal Register, Vol. 80, No. 146, p. 45429, July 30, 2015), the May 2016 Subject Matter Eligibility Update (Federal Register, Vol. 81, No. 88, p. 27381, May 6, 2016), and the 2019 Revised Patent Subject Matter Eligibility Guidance (Federal Register, Vol. 84, No. 4, page 50, January 7, 2019) and the 2024 Update on Subject Matter Eligibility (Federal Register, Vol 89, No. 137, page 58128, July 17, 2024).
The analysis of claim 68 is as follows:
Step 1: Claim 68 is drawn to a process.
Step 2A – Prong One: Claim 68 recites an abstract idea. In particular, claim 68 recites the following limitations:
[A1] deliver at least one indication
[B1] classification of at least one PTSD patient according to gender and/or according to trauma origin
[C1] deliver said NF treatment to said PTSD patient based on said at least one protocol or indications thereof
[D1] generate an indication to perform an assessment of results of said NF treatment within a time period between 8 weeks and 12 weeks from initiating the delivery of said NF treatment
These elements [A1]-[D1] of claim 68 are drawn to an abstract idea since they involve a mental process that can be practically performed in the human mind including observation, evaluation, judgment, and opinion and using pen and paper. In particular, the classification is readily performed in the human mind, the delivery of an indication may be any drawn image or text shown to the user. The delivering of a neurofeedback treatment is not particularly limited and may include drawing particular shapes, making particular noises, or other forms of stimulation or treatment being performed by a clinician. The limitation of generating an indication to perform an assessment of results of said NF treatment within a given time period does not include the actual measurement of results but is instead a limitation drawn towards generating a reminder to perform such an assessment at some point in time. Each of these steps are readily performed by a trained clinician using nothing more than pen and paper.
Step 2A – Prong Two: Claim 68 recites the following additional limitations that are beyond the judicial exception:
[A2] at least one user interface
[B2] a control unit comprising a memory and control circuitry
These elements [A2]-[B2] of claim 68 do not integrate the exception into a practical application of the exception. In particular, the elements [A2]-[B2] are merely an instruction to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.04(d) and MPEP 2106.05(f).
Step 2B: Claim 68 does not recite additional elements that amount to significantly more than the judicial exception itself. In particular, the recitation “generate an indication to perform an assessment of results of said NF treatment within a time period between 8 weeks and 12 weeks from initiating the delivery of said NF treatment” does not qualify as significantly more because this limitation merely requires the generation of an “indication” to perform assessment of results of said NF treatment within a given timeframe. This limitation does not include performing the assessment of results itself and further does not indicate that any measurable change or effect is induced by the treatment. This limitation is considered analogous to writing a note to perform additional assessments at a later date.
Further, the elements [A2]-[B2] do not qualify as significantly more because this limitation is simply appending well-understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014)) and/or a claim to an abstract idea requiring no more than being stored on a computer readable medium which is a well-understood, routine and conventional activity previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014); SAP Am. v. InvestPic, 890 F.3d 1016 (Fed. Circ. 2018)).
In view of the above, the additional elements individually do not integrate the exception into a practical application and do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations as an ordered combination (that is, as a whole) adds nothing that is not already present when looking at the elements taking individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process.
Claim 69 depends from claim 68, and recite the same abstract idea as claim 68. Furthermore, these claims only contain recitations that further limit the abstract idea (that is, the claims only recite limitations that further limit the algorithm).
The claim limitations of claim 69 do not integrate the exception into a practical application. In particular, the elements of claim 69 are considered to incorporate the assessment of results into the system and additionally include the step of generating an indication based on the results but unlike claim 51, claim 69 does not indicate that any effect has been achieved by the presentation of the NF treatment. The claim only requires the processing of the assessment results and does not require any comparison to previous assessments or the like that would indicate that the NF treatment had a measurable impact on the patient. Thus the NF treatment of claims 68-69 is not considered to qualify as a particular treatment and the claims are not considered to be incorporated into a practical application.
In view of the above, the additional elements individually do not integrate the exception into a practical application and do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations of each claim as an ordered combination in conjunction with the claims from which they depend (that is, as a whole) adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process.
Claims 51-67 are not rejected under 35 USC 101 because claim 51 recites the presentation of a neurofeedback (NF) treatment, in combination with a measurable change in the subject being achieved by the treatment. As described above, the presentation of the neurofeedback treatment alone is not considered to amount to significantly more since the treatment, as presently claimed, is not particularly limited and may include a mere display of an image or audio signal not requiring any form of adaptive feedback with the user. However, claim 51 presents the treatment in combination with a direct measurement of the treatment result. The claimed reduction in CAPS-5 score is directly tied to the delivering of the treatment. As such, the method of claim 51 is incorporated into a practical application because the delivering of the NF treatment produces a measurable therapeutic effect on the patient.
Claim 70 is not rejected under 35 USC 101 because claim 70 does not recite any abstract ideas and is instead directed towards a particular display or image which causes a measurable effect in the patient.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 68-70 are rejected under 35 U.S.C. 103 as being unpatentable over Hendler US Patent Application Publication Number US 20210290132 A1 hereinafter Hendler.
Regarding claim 68 Hendler teaches a system for delivering of a neurofeedback treatment for treating PTSD, comprising:
at least one user interface, configured to deliver at least one indication (Paragraph 0160: the interface for delivering the cues);
a control unit (Paragraph 0191: the control unit), comprising:
a memory (Paragraphs 0193-0194: the memory), wherein said memory stores at least one protocol of a neurofeedback (NF) treatment or indications thereof (Paragraphs 0173-0177 and Figs. 2G and 4: the delivering of the trauma context training and maintenance training; Paragraphs 0183-0189 and Fig. 3: the delivering of the NF treatment. The NF treatment is delivered and thus the treatment protocol must be stored on a memory. Thus the protocol stored on a memory is considered to be taught by the delivery of such a treatment using a computer-based system), and information about classification of at least one PTSD patient according to gender and/or according to trauma origin (Paragraphs 0245-0246: Tables 1a and 1b the classification of subjects into groups based on their trauma type, or origin and gender. Each trial has a known population based on sex, trauma type, age, and time since trauma. Thus the patient demographics are known and each patient has been “classified” into their respective groups. The information is considered to be taught as stored in the memory since the classification information is known and the system is a computer-implemented system.); and
a control circuitry (Paragraph 0192: the control circuitry), wherein said control circuitry is configured to deliver said NF treatment to said PTSD patient based on said at least one protocol or indications thereof stored in said memory (Paragraphs 0173-0177 and Figs. 2G and 4: the delivering of the trauma context training and maintenance training; Paragraphs 0183-0189 and Fig. 3: the delivering of the NF treatment.), and to signal said at least user interface to generate an indication to perform an assessment of results of said NF treatment within a time period from initiating the delivery of said NF treatment (Fig. 5: the timeline displaying when assessments occur. While Fig. 5 is not explicitly recited as being displayed, the illustration of such a timeline is considered sufficient to at least suggest that the timeline may be displayed and thus provides an “indication” to perform assessment of results of the FN treatment at given time periods from initiating delivery of the NF treatment; Paragraphs 0235, 0243 and Fig. 15; the assessed outcome of the treatment).
Handler fails to teach the indication to perform an assessment of results of said NF treatment being within a time period between 8 weeks and 12 weeks from initiating the delivery of said NF treatment
The particular timeframe in which the assessments should be performed from initiating the delivery of the NF treatment is considered to be a matter of routine optimization and experimentation. Applicant does not establish criticality for assessing the change in patient condition as measured by CAPS-5, or any other metric, at any particular time point following the treatment being delivered. This is evidenced by Applicant’s specification paragraphs 0313-0314, 0325, and 0342 which recite a number of different timeframes in which the outcome assessment is performed. Thus it would seem that the particular timeframe which the indication presents for carrying out the assessment is not critical. Thus it would seem that the timeframe in which treatment progress should be assessed is a results driven variable that is subject to routine optimization and experimentation to customize the treatment and assessments to best suit the specific patient or patient population based on their specific needs, training effectiveness, and other factors a clinician would consider to adapt a treatment outcome timeline to best suit a particular patient or patient group. Applicant does not establish criticality for the given timeframe in which the assessment is carried out and one of ordinary skill in the art would recognize the timeline of assessment as a results driven variable that would be optimized by a clinician depending on the patient’s needs such as severity of PTSD and anticipated response to treatment and as such displaying the indication to perform an assessment within a time period of 8-12 weeks from initiating delivery of the NF is considered to be rendered obvious by Hendler.
Regarding claim 69, Handler teaches the system according to claim 68. Handler further teaches the system wherein said control unit is configured to process the assessment results and generate a human detectable indication based on the processed assessment results (Paragraphs 0235, 0243 and Fig. 15; the displayed outcome of the treatment based on the assessments).
Regarding claim 70 Hendler teaches dynamic audio-visual interface delivered during a PTSD treatment to a PTSD patient classified according to gender and/or trauma origin, wherein said dynamic audio-visual interface is configured to be modified during said treatment (Paragraphs 0160-0162: the dynamic modification of the interface based on detected activity; Paragraphs 0245-0246: Tables 1a and 1b the classification of subjects into groups based on their trauma type, or origin and gender. Each trial has a known population based on sex, trauma type, age, and time since trauma. Thus the patient demographics are known and each patient has been “classified” into their respective groups)
to achieve a reduction of at least 6 points in a Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) in said PTSD patient (Paragraphs 0235, 0243 and Fig. 15: the reductions in CAPS-5 scores achieved by the treatment including an average of about 10 point reduction for Amyg-EFP-NF) after a time period of between 8 weeks and 12 weeks of said treatment, or up to 3 months from completion of said treatment (Fig. 5: the outcome assessment was performed at week 15 which followed training in weeks 2-7 and 9-14 for a total of 12 weeks of training. Thus the results were achieved after a time period between 8 and 12 weeks of said delivering. Handler fails to explicitly recite that the results illustrated in Fig. 15 and discussed in paragraphs 0235 and 0243 are the results recorded at week 15 of the timeline illustrated in Fig. 5 but the assessment results in Fig. 15 being labeled as “post” assessment of CAPS-5 in combination with the teachings of Fig. 5 that the last CAPS-5 assessment is carried out in week 15 is considered sufficient to at least suggest that the results in Fig. 15 and discussed in paragraphs 0235 and 0243 are the assessment results recorded in week 15 of Fig. 5).
Claims 51-53, 55-56, 58-59, 61-62, 64-65, and 67 are rejected under 35 U.S.C. 103 as being unpatentable over Hendler US Patent Application Publication Number US 20210290132 A1 hereinafter Hendler in view of Foa et. al. “Guidelines for Treatment of PTSD” published by the Journal of Traumatic stress, 2000, pages 539-588 hereinafter Foa.
Regarding claim 51, Hendler discloses a method for treating post-traumatic stress disorder (PTSD), comprising:
classifying PTSD patients according to gender and/or trauma origin (Paragraphs 0245-0246: Tables 1a and 1b the classification of subjects into groups based on their trauma type, or origin and gender. Each trial has a known population based on sex, trauma type, age, and time since trauma. Thus the patient demographics are known and each patient has been “classified” into their respective groups);
selecting a specific sub-population of patients (Paragraphs 0245-0246: Tables 1a and 1b: specific sub-populations were selected based on the user demographics, or classifications, to form balanced, randomized groups for each of the different tests. The populations appear to have been randomized according to age and time since trauma rather than based on sex or trauma origin. Thus a specific sub-population is selected but it is not considered to be based on “said classifying” as the basis does not include the classification categories established above.);
delivering a neurofeedback (NF) treatment to said specific sub-population of patients (Paragraphs 0245-0246: Tables 1a and 1b: the two neurofeedback groups; Paragraphs 0173-0177 and Fig.2G the delivering of the trauma context training and maintenance training; Paragraphs 0183-0189 and Fig. 3: the delivering of the NF treatment;
achieving a reduction of at least 6 points in average in a Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) scale in said selected specific sub-population (Paragraph 0243: a reduction of approximately 10 points; Fig. 15: both of the NF treatment groups showed significant reductions in the average CAPS-5 score for their respective patient populations. The difference between the averages for neutral NF appears to be about 7 points and the difference for the trauma NF appears to be about 12 points; Paragraph 0235), after a time period between 8 weeks and 12 weeks of said delivering, or up to 3 months from said delivering (Fig. 5: the outcome assessment was performed at week 15 which followed training in weeks 2-7 and 9-14 for a total of 12 weeks of training. Thus the results were achieved after a time period between 8 and 12 weeks of said delivering. Handler fails to explicitly recite that the results illustrated in Fig. 15 and discussed in paragraphs 0235 and 0243 are the results recorded at week 15 of the timeline illustrated in Fig. 5 but the assessment results in Fig. 15 being labeled as “post” assessment of CAPS-5 in combination with the teachings of Fig. 5 that the last CAPS-5 assessment is carried out in week 15 is considered sufficient to at least suggest that the results in Fig. 15 and discussed in paragraphs 0235 and 0243 are the assessment results recorded in week 15 of Fig. 5).
Furthermore, both the particular time point at which the effect of the treatment is assessed and the required reduction in points in a given scoring methodology are each considered to be matters of routine optimization and experimentation that do not result in a surprising technical effect. Applicant does not establish criticality for assessing the change in patient condition as measured by CAPS-5, or any other metric, at any particular time point following the treatment being delivered or establish criticality for a specific reduction in points. This is evidenced by Applicant’s specification paragraphs 0313-0314, 0325, and 0342 which recite a number of different timeframes in which the outcome assessment is performed to achieve the desired result, paragraph 0241 which establishes that any reduction in points in CAPS-5 can be achieved, Paragraphs 0342-0348 and Table A which discloses the average value of PCL-5 and PHQ-9 scale point reductions for various sub-populations after 8 weeks of NF training, but does not establish any evidence of criticality or a surprising technical effect achieved but the average level of reduction. Rather these values are merely the observed results. Additionally, the fact that claim 51 is directed towards two different acceptable timeframes for achieving the desired reduction in points further indicates that the timeframe in which the desired reduction is achieved is not critical but rather a matter of routine optimization and experimentation. Furthermore, Hendler teaches that the number and/or duration of treatment sessions is customizable similar to common PTSD intervention (Hendler: Paragraph 0219) and further teaches that a “meaningful” reduction in CAPS-5 points may be set at a reduction of 5 points (Hendler: Paragraph 0236). Thus it would seem that the number and duration of treatment, target reduction in points in the given evaluation methodology, as well as the schedule used to assesses treatment progress are each results driven variables that are subject to routine optimization and experimentation to customize the treatment and assessments to best suit the specific patient or patient population based on their specific needs, training effectiveness, and other factors a clinician would consider to adapt a treatment to best suit a particular patient or patient group. Additionally, the required score reduction may be arbitrarily set at any value that the clinician determines is acceptable for the given timeframe of treatment or that shows a significant improvement. Applicant does not establish criticality for any of the claimed point reductions throughout the claims. As such, the required number of sessions, frequency of training, required reduction in points, and the time frame in which the reduction in points is achieved are all considered matters of routine optimization and experimentation as being directed towards results driven variables.
Examiner’s Note: All dependent claims are addressed in light of the above obviousness rationale regarding the specific score reduction required and the timeframe in which that score is achieved. The above rationale will be referred to as the score and timing optimization rationale.
Hendler fails to further teach the method including: selecting a specific sub-population of patients according to said classifying
Foa teaches guidelines for treating patients with PTSD (Introduction: Pages 539-540). Thus, Foa falls within the same field of endeavor as Applicant’s invention.
Foa teaches that there is no conclusive evidence that indicates that that trauma associated with combat is more resistant to treatment than trauma associated with civilian, or other traumatic experiences. Foa further teaches that further studies that control for additional variables and treatment modalities are required before gender can be attributed to differences in treatment outcomes. Foa teaches that a variety of different patient classification such as the type of trauma experienced, number of traumas experienced, chronicity of PTSD, gender, age, and whether the patient is a child or elder may be associated with differenced in PTSD treatment outcomes but that additional studies are required before any conclusions can be made (Pages 542-544: Clinical Issues). Thus, FOA teaches that it may be beneficial to analyze the results of these various groups to determine if there are any differences in treatment outcomes as such data would be useful in establishing if any of these factors, or groups, attribute to differences in treatment outcomes.
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to configure the method of Hendler to divide the patient populations according to trauma type and/or gender because Foa teaches that additional research is desirable into differences in treatment response for these classifications of patients and dividing the patients according to these classifications provides additional insight into whether there is any difference in treatment response based on gender or trauma origin which may allow the method to better adapt for future patients based on the differences in response.
Regarding claims 52-53. Hendler in view of Foa teaches the method according to claim 51. Handler fails to further teach the method comprising: wherein said achieving comprises achieving a reduction of at least 4 points in average in a PTSD Checklist for DSM-5 (PCL-5) scale in said selected specific sub-population, after a time period of at least 8 weeks of said delivering, or wherein said achieving comprises achieving a reduction of between 8 and 17 points in average in a PCL-5 scale in said selected specific sub-population, up to 3 months from said delivering.
Hendler teaches that a PTSD Checklist Questionnaire (PCL) may be used as the assessment method (Paragraphs 0063, 0247, and 0258-0259; Figs. 18 and 23C-23D) and further teaches using DSM-5 as the assessment criteria for PTSD (Paragraphs 0151-0152 and 0164). Thus, Hendler is considered to at least suggest using a PTSD Checklist for DSM-5 (PCL-5) scale since Hendler teaches the use of PCLs for assessment and is based around the PTSD diagnosis established in DSM-5, but fails to teach the recited reductions in points in the recited timeframes.
As described above in the score and timing optimization rationale, the particular score reduction achieved and the timing with which such a reduction is achieved are considered matters of routine optimization and experimentation as such factors are results driven variables that are optimizable to the particular patient or patient population being assessed and any arbitrary success criteria. As such, the claimed score reductions using a PCL-5 scale in the given timeframes are considered to be rendered obvious by Hendler in view of Foa.
Regarding claims 55, 58, 61, and 64, Hendler in view of Foa teaches the method according to claim 51. Each of these claims are directed towards the selection of a different specific sub-population (55 – females, 58 – males, 61 – non-civilian trauma PTSD, and 64 – civilian trauma PTSD) and claims 55, 58, and 64 are further directed towards establishing a corresponding CAPS-5 reduction for the specific sub-population in a given timeframe (55 – 10 point reduction after at least 8 weeks, 58 – 6 point reduction after at least 8 weeks, and 64 – 10 point reduction after at least 8 weeks)
As described in the above presented rejection of claim 1, Foa teaches that each of the above sub-populations, (female, male, combat related PTSD, and civilian PTSD) are sub-populations where additional analysis is required before any difference in treatment response can be attributed to the sub-population parameter (Foa: Pages 542-544: Clinical Issues: the types of trauma and gender categories).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to configure the method of Hendler in view of Foa to divide the patient populations according to trauma type and/or gender because Foa teaches that additional research is desirable into differences in treatment response for these classifications of patients and dividing the patients according to these classifications provides additional insight into whether there is any difference in treatment response based on gender or trauma origin which may allow the method to better adapt for future patients based on the differences in response.
Additionally, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the invention to assign each of the different sub-populations with a unique goal reduction of CAPS-5 points within a given timeframe because each of these sub-populations may have different anticipated treatment responsiveness and may further have different baseline levels and thus assigning each sub-population their own target point reduction allows the target point reduction to be customized to fit the expected treatment outcomes for each sub-population. Additionally, as described above in the score and timing optimization rationale, the particular score reduction achieved and the timing with which such a reduction is achieved are considered matters of routine optimization and experimentation as such factors are results driven variables that are optimizable to the particular patient or patient population being assessed and any arbitrary success criteria. As such, the various claimed score reductions using a CAPS-5 scale in the given timeframes are considered to be rendered obvious by Hendler in view of Foa.
Regarding claims 56, 59, 62, and 65 Hendler in view of Foa teaches the method according to claims 55, 58, 61, and 64 respectively. Each of these claims are further directed towards establishing a required degree of reduction in a PCL-5 scale in the corresponding sub-population after a given timeframe (56 – 9 point PCL reduction after 8 weeks, 59 – 4 point PCL reduction after 8 weeks, 62 – 3 point PCL reduction after 8 weeks, 65 – 10 point PCL reduction after 8 weeks).
Hendler teaches that a PTSD Checklist Questionnaire (PCL) may be used as the assessment method (Paragraphs 0063, 0247, and 0258-0259; Figs. 18 and 23C-23D) and further teaches using DSM-5 as the assessment criteria for PTSD (Paragraphs 0151-0152 and 0164). Thus, Hendler is considered to at least suggest using a PTSD Checklist for DSM-5 (PCL-5) scale since Hendler teaches the use of PCLs for assessment and is based around the PTSD diagnosis established in DSM-5, but fails to teach the recited reductions in points in the recited timeframes.
As described above in the score and timing optimization rationale, the particular score reduction achieved and the timing with which such a reduction is achieved are considered matters of routine optimization and experimentation as such factors are results driven variables that are optimizable to the particular patient or patient population being assessed and any arbitrary success criteria. As such, the claimed score reductions using a PCL-5 scale in the given timeframes are considered to be rendered obvious by Hendler in view of Foa.
Regarding claim 67. Hendler in view of Foa teaches the method according to claim 51. Handler further teaches the method comprising wherein said delivering comprises training said selected sub-population using said NF treatment to modulate activation of the Amygdala or activation of at least one related brain region or at least one biomarker thereof (Paragraphs 0216-0221: the process may include training the subjects to modulate selected brain regions; Fig. 2A; Paragraphs 0066-0070: the brain region being modulated may include the amygdala or related brain regions; Paragraph 0160: the monitoring of the amygdala to modify the interface).
Claims 54, 57, 60, 63, and 66 are rejected under 35 U.S.C. 103 as being unpatentable over Hendler US Patent Application Publication Number US 20210290132 A1 hereinafter Hendler in view of Foa et. al. “Guidelines for Treatment of PTSD” published by the Journal of Traumatic stress, 2000, pages 539-588 hereinafter Foa as applied to claims 51, 55, 58, 61, and 64 above and further in view of Malik US Patent Application Publication Number US 20120270199 A1 hereinafter Malik.
Regarding claim 54 Hendler in view of Foa teaches the method according to claim 51. Handler fails to further teach the method comprising wherein said achieving comprises achieving a reduction of between 2 and 5 points in average in a Patient Health Questionnaire-9 (PHQ-9) scale in said selected specific sub-population, up to 3 months from said delivering.
Hendler further teaches the assessment of secondary clinical outcomes using additional questionnaires in order to further clinically characterize the patient. Hendler teaches using questionnaires for anxiety, depression, alexithymia, and emotional regulation (Paragraph 0247). Thus, Hendler teaches the use of depression questionnaires to further clinically characterize the patients but fails to teach the use of the PHQ-9 questionnaire and the recited reduction in points.
Malik teaches a method and system for assessing a latent trait such as a psychiatric disorder in a test subject (Abstract). Thus, Malin is reasonably pertinent to the problem at hand.
Malik teaches the use of the PHQ-9 questionnaire to assess the severity of depression in a patient and teaches that the use of such a questionnaire is common (Paragraphs 0008-0009).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to modify the method of Hendler in view of Foa to utilize the PHQ-9 depression questionnaire rather than the Beck Depression Inventory taught by Hendler because such a change is a simple substitution of one known element (the Beck depression questionnaire of Hendler) for another known element (the PHQ-9 questionnaire of Malik) with no surprising technical effect (the questionnaires both assess depression).
Furthermore, as described above in the score and timing optimization rationale, the particular score reduction achieved and the timing with which such a reduction is achieved are considered matters of routine optimization and experimentation as such factors are results driven variables that are optimizable to the particular patient or patient population being assessed and any arbitrary success criteria. As such, the claimed score reductions using a PHQ-9 scale in the given timeframes are considered to be rendered obvious by Hendler in view of Foa further in view of Malik.
Regarding claims 57, 60, 63, and 66 Hendler in view of Foa teaches the method according to claims 55, 58, 61, and 64 respectively. Each of these claims are further directed towards establishing a required degree of reduction in a PHQ-9 scale in the corresponding sub-population after a given timeframe (57 – 2 point PHQ-9 reduction after 8 weeks, 60 – 1 point PHQ-9 reduction after 8 weeks, 63 – 1 point PHQ-9 reduction after 8 weeks, 66 – 3 point PHQ-9 reduction after 8 weeks).
Hendler further teaches the assessment of secondary clinical outcomes using additional questionnaires in order to further clinically characterize the patient. Hendler teaches using questionnaires for anxiety, depression, alexithymia, and emotional regulation (Paragraph 0247). Thus, Hendler teaches the use of depression questionnaires to further clinically characterize the patients but fails to teach the use of the PHQ-9 questionnaire and the recited reduction in points.
Malik teaches the use of the PHQ-9 questionnaire to assess the severity of depression in a patient and teaches that the use of such a questionnaire is common (Paragraphs 0008-0009).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to modify the method of Hendler in view of Foa to utilize the PHQ-9 depression questionnaire rather than the Beck Depression Inventory taught by Hendler because such a change is a simple substitution of one known element (the Beck depression questionnaire of Hendler) for another known element (the PHQ-9 questionnaire of Malik) with no surprising technical effect (the questionnaires both assess depression).
Furthermore, as described above in the score and timing optimization rationale, the particular score reduction achieved and the timing with which such a reduction is achieved are considered matters of routine optimization and experimentation as such factors are results driven variables that are optimizable to the particular patient or patient population being assessed and any arbitrary success criteria. As such, the claimed score reductions using a PHQ-9 scale in the given timeframes are considered to be rendered obvious by Hendler in view of Foa further in view of Malik.
Conclusion
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/MATTHEW ERIC OGLES/Examiner, Art Unit 3791
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