DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
The information disclosure statement (IDS) was submitted on 2/28/2026. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Amendment
This action is in response to the remarks filed on 2/27/2026. The amendments filed on 2/27/2026 are entered.
The previous rejections of claims 1-20 under 35 U.S.C. 112(b) have been withdrawn in light of the applicant’s remarks/amendments.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to abstract ideas of “mental processes”, “concepts relating to data comparisons that can be performed mentally or are analogous to human mental work”, or “mathematical calculations” without significantly more.
Analyses of the subject matter eligibility tests are performed for each of the independent claims and associated dependent claims below.
Regarding independent claim 1, the claim recites:
The limitation of “measuring changes in regional cerebral blood flow (rCBF), on a normalized individual level, in a left orbitofrontal cortex, a left insula, a right cingulate cortex, and a left putamen of the patient’s brain based on the first ASL scan and the second ASL scan” is considered to be an abstract idea of a mental process and concept relating to data comparisons that can be performed mentally or are analogous to human mental work as a user may merely think and receive within the mind about a first scan and a second scan and make mental measurements about changes across the two images. The “normalized individual level” data processing of the images is considered to be an abstract idea of mathematical calculations of the input images. The limitation of “determining that the treatment succeeded when either: (i) rCBF increased by at least 0.1 in the left orbitofrontal cortex; or (ii) rCBF increased by any amount in the left orbitofrontal cortex and in at least two of the left insula, right cingulate cortex, and left putamen; and determining that the treatment failed when it is not determined that the treatment succeeded” is considered to be an abstract idea of a mental process and concept relating to data comparisons that can be performed mentally or are analogous to human mental work as a user may merely think and receive within the mind about increases in different regions of acquired brain images and make a clinical determination based upon the data. Therefore, the claim is directed to an abstract idea and a judicial exception.
Step 2A Prong 2 Analysis (Claim 1): This judicial exception is not integrated into a practical application because it does not recite any elements that integrate the abstract idea into a practical application such as improving the operation of the diagnostic device, or effecting a particular treatment or prophylaxis for a disease or medical condition. The claims do not recite any features of components that integrates the judicial exception into a practical application because the additional recited elements of “obtaining a first arterial spin labeling (ASL) scan of a patient’s brain pre-treatment with an iboga-alkaloid for a neuropsychiatric condition”, and “obtaining a second ASL scan of the patient’s brain post-treatment” form extra-solution activity of mere data gathering. Therefore, all of these claimed elements are not sufficient to improve the functioning of a diagnostic device or form of technology. Furthermore, while directed to activity for medical diagnostics, the claimed steps do not effect a particular treatment or prophylaxis for a disease or medical condition as it is only claiming diagnostic measurement steps and not altering a particular treatment in any way.
Step 2B Analysis (Claim 1): The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional recited elements of “obtaining a first arterial spin labeling (ASL) scan of a patient’s brain pre-treatment with an iboga-alkaloid for a neuropsychiatric condition”, and “obtaining a second ASL scan of the patient’s brain post-treatment” form extra-solution activity of mere data gathering. The limitations do not include improvements to the functioning of a computer or to any other technology or technical field, and the elements of the claim further do not effect a particular treatment or prophylaxis for a disease or medical condition. Furthermore, there are no claimed features that provide elements to identify improvements to general computing technologies based on the claimed features. As discussed above, limitations form insignificantly extra-solution activity, and link the judicial exception to generic medical diagnostics. Therefore the additional elements do not amount to significantly more.
Dependent claim 2 includes limitations that are directed to re-treating a patient based upon a treatment fail determination and a determination about rCBF in the left orbitofrontal cortex. This narrows the mental processing abstract idea of the independent claim and also includes a limitation to treatment. This limitation merely states “re-treating” without any particularity to how the treatment occurs or what type of treatment this should include. Therefore, the limitation is not considered to integrate the recited abstract ideas into a practical application because it does not form a “particular” treatment and is merely instructions to apply the exception in a generic way.
Dependent claim 3 includes limitations that are directed to re-treating a patient based upon a treatment fail determination and a determination about rCBF in brain regions. This narrows the mental processing abstract idea of the independent claim and also includes a limitation to treatment. This limitation merely states “re-treating” without any particularity to how the treatment occurs or what type of treatment this should include. Therefore, the limitation is not considered to integrate the recited abstract ideas into a practical application because it does not form a “particular” treatment and is merely instructions to apply the exception in a generic way.
Dependent claim 4 includes limitations that are directed to re-treating a patient based upon a treatment fail determination and a determination about rCBF in brain regions. This narrows the mental processing abstract idea of the independent claim and also includes a limitation to treatment. This limitation merely states “re-treating” without any particularity to how the treatment occurs or what type of treatment this should include. Therefore, the limitation is not considered to integrate the recited abstract ideas into a practical application because it does not form a “particular” treatment and is merely instructions to apply the exception in a generic way.
Dependent claim 5 includes limitations that are directed to narrowing the type of neuropsychiatric condition which merely narrows the extra-solution activity of mere data gathering to limit to a particular form of acquired data. Therefore, it does not integrate the judicial exception of the independent claim into a practical application or amount to significantly more.
Dependent claim 6 includes limitations that are directed to narrowing the type of neuropsychiatric condition which merely narrows the extra-solution activity of mere data gathering to limit to a particular form of acquired data. Therefore, it does not integrate the judicial exception of the independent claim into a practical application or amount to significantly more.
Dependent claim 7 includes limitations that are directed to narrowing the type of neuropsychiatric condition which merely narrows the extra-solution activity of mere data gathering to limit to a particular form of acquired data. Therefore, it does not integrate the judicial exception of the independent claim into a practical application or amount to significantly more.
Dependent claim 8 includes limitations that are directed to narrowing the type of time period for acquiring an imaging scan which merely narrows the extra-solution activity of mere data gathering to limit to a particular time period of acquired data. Therefore, it does not integrate the judicial exception of the independent claim into a practical application or amount to significantly more.
Regarding independent claim 9, the claim recites:
The limitation of “measure changes in regional cerebral blood flow (rCBF), on a normalized individual level, in a left orbitofrontal cortex, a left insula, a right cingulate cortex, and a left putamen of the patient’s brain based on the first ASL scan and the second ASL scan” is considered to be an abstract idea of a mental process and concept relating to data comparisons that can be performed mentally or are analogous to human mental work as a user may merely think and receive within the mind about a first scan and a second scan and make mental measurements about changes across the two images. The “normalized individual level” data processing of the images is considered to be an abstract idea of mathematical calculations of the input images. The limitation of “provide a determination that the treatment succeeded when either: (i) rCBF increased by at least 0.1 in the left orbitofrontal cortex; or (ii) rCBF increased by any amount in the left orbitofrontal cortex and in at least two of the left insula, right cingulate cortex, and left putamen; and provide a determination that the treatment failed when it is not determined that the treatment succeeded” is considered to be an abstract idea of a mental process and concept relating to data comparisons that can be performed mentally or are analogous to human mental work as a user may merely think and receive within the mind about increases in different regions of acquired brain images and make a clinical determination based upon the data. Therefore, the claim is directed to an abstract idea and a judicial exception.
Step 2A Prong 2 Analysis (Claim 9): This judicial exception is not integrated into a practical application because it does not recite any elements that integrate the abstract idea into a practical application such as improving the operation of the diagnostic device, or effecting a particular treatment or prophylaxis for a disease or medical condition. The claims do not recite any features of components that integrates the judicial exception into a practical application because the additional recited elements of “a magnetic resonance imaging (MRI) machine capable of arterial spin labeling (ASL) imaging; and a treatment verification device, comprising: a processor; and a memory, the memory storing a treatment verification application that configures the processor to” form generic computing elements in the art of medical imaging which the abstract idea is merely implemented or performed on a generic computer device. While a computer is used to implement the abstract idea, the recited judicial exception does not improve how the functioning of a computer occurs. The claims do not recite any features of components that integrates the judicial exception into a practical application because the additional recited elements of “obtaining a first arterial spin labeling (ASL) scan of a patient’s brain pre-treatment with an iboga-alkaloid for a neuropsychiatric condition”, and “obtaining a second ASL scan of the patient’s brain post-treatment” form extra-solution activity of mere data gathering. Therefore, all of these claimed elements are not sufficient to improve the functioning of a diagnostic device or form of technology. Furthermore, while directed to activity for medical diagnostics, the claimed steps do not effect a particular treatment or prophylaxis for a disease or medical condition as it is only claiming diagnostic measurement steps and not altering a particular treatment in any way.
Step 2B Analysis (Claim 9): The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional recited elements of “a magnetic resonance imaging (MRI) machine capable of arterial spin labeling (ASL) imaging; and a treatment verification device, comprising: a processor; and a memory, the memory storing a treatment verification application that configures the processor to” form generic computing elements in the art of medical imaging which the abstract idea is merely implemented or performed on a generic computer device. While a computer is used to implement the abstract idea, the recited judicial exception does not improve how the functioning of a computer occurs. Evidentiary reference Petcharunpaisan, S., et al., “Arterial Spin labeling in neuroimaging,” World Journal of Radiology. Vol 2(10), 2010. P. 384-398 teaches to arterial spin labeling MRI on page 385, col 1, paragraphs 2-3, being a routinely used technology and capable of being used on magnetic resonance imaging machines. Therefore, the limitation of “a magnetic resonance imaging machine” therefore forms well-understood, routine, and conventional activity in the field and therefore does not amount to significantly more. The claims do not recite any features of components that amount to significantly more because the additional recited elements of “obtaining a first arterial spin labeling (ASL) scan of a patient’s brain pre-treatment with an iboga-alkaloid for a neuropsychiatric condition”, and “obtaining a second ASL scan of the patient’s brain post-treatment” form extra-solution activity of mere data gathering. The limitations do not include improvements to the functioning of a computer or to any other technology or technical field, and the elements of the claim further do not effect a particular treatment or prophylaxis for a disease or medical condition. Furthermore, there are no claimed features that provide elements to identify improvements to general computing technologies based on the claimed features. As discussed above, any limitations form insignificantly extra-solution activity, and link the judicial exception to generic medical diagnostics. Therefore, the additional elements do not amount to significantly more.
Dependent claim 10 includes limitations that are directed to re-treating a patient based upon a treatment fail determination and a determination about rCBF in the left orbitofrontal cortex. This narrows the mental processing abstract idea of the independent claim and also includes a limitation to treatment. This limitation merely states “re-treating” without any particularity to how the treatment occurs or what type of treatment this should include. Therefore, the limitation is not considered to integrate the recited abstract ideas into a practical application because it does not form a “particular” treatment and is merely instructions to apply the exception in a generic way.
Dependent claim 11 includes limitations that are directed to re-treating a patient based upon a treatment fail determination and a determination about rCBF in brain regions. This narrows the mental processing abstract idea of the independent claim and also includes a limitation to treatment. This limitation merely states “re-treating” without any particularity to how the treatment occurs or what type of treatment this should include. Therefore, the limitation is not considered to integrate the recited abstract ideas into a practical application because it does not form a “particular” treatment and is merely instructions to apply the exception in a generic way.
Dependent claim 12 includes limitations that are directed to re-treating a patient based upon a treatment fail determination and a determination about rCBF in brain regions. This narrows the mental processing abstract idea of the independent claim and also includes a limitation to treatment. This limitation merely states “re-treating” without any particularity to how the treatment occurs or what type of treatment this should include. Therefore, the limitation is not considered to integrate the recited abstract ideas into a practical application because it does not form a “particular” treatment and is merely instructions to apply the exception in a generic way.
Dependent claim 13 includes limitations that are directed to narrowing the type of neuropsychiatric condition which merely narrows the extra-solution activity of mere data gathering to limit to a particular form of acquired data. Therefore, it does not integrate the judicial exception of the independent claim into a practical application or amount to significantly more.
Dependent claim 14 includes limitations that are directed to narrowing the type of neuropsychiatric condition which merely narrows the extra-solution activity of mere data gathering to limit to a particular form of acquired data. Therefore, it does not integrate the judicial exception of the independent claim into a practical application or amount to significantly more.
Dependent claim 15 includes limitations that are directed to narrowing the type of neuropsychiatric condition which merely narrows the extra-solution activity of mere data gathering to limit to a particular form of acquired data. Therefore, it does not integrate the judicial exception of the independent claim into a practical application or amount to significantly more.
Dependent claim 16 includes limitations that are directed to narrowing the type of time period for acquiring an imaging scan which merely narrows the extra-solution activity of mere data gathering to limit to a particular time period of acquired data. Therefore, it does not integrate the judicial exception of the independent claim into a practical application or amount to significantly more.
Regarding independent claim 17, the claim recites:
The limitation of “measuring changes in regional cerebral blood flow (rCBF), on a normalized individual level, in a left orbitofrontal cortex, a left insula, a right cingulate cortex, and a left putamen of the patient’s brain based on the first ASL scan and the second ASL scan” is considered to be an abstract idea of a mental process and concept relating to data comparisons that can be performed mentally or are analogous to human mental work as a user may merely think and receive within the mind about a first scan and a second scan and make mental measurements about changes across the two images. The “normalized individual level” data processing of the images is considered to be an abstract idea of mathematical calculations of the input images. The limitation of “determining that the treatment succeeded when either: (i) rCBF increased by at least 0.1 in the left orbitofrontal cortex; or (ii) rCBF increased by any amount in the left orbitofrontal cortex and in at least two of the left insula, right cingulate cortex, and left putamen; and determining that the treatment failed when it is not determined that the treatment succeeded” is considered to be an abstract idea of a mental process and concept relating to data comparisons that can be performed mentally or are analogous to human mental work as a user may merely think and receive within the mind about increases in different regions of acquired brain images and make a clinical determination based upon the data. Therefore, the claim is directed to an abstract idea and a judicial exception.
Step 2A Prong 2 Analysis (Claim 17): This judicial exception is not integrated into a practical application because it does not recite any elements that integrate the abstract idea into a practical application such as improving the operation of the diagnostic device, or effecting a particular treatment or prophylaxis for a disease or medical condition. The claims do not recite any features of components that integrates the judicial exception into a practical application because the additional recited elements of “obtaining a first arterial spin labeling (ASL) scan of a patient’s brain pre-treatment with an iboga-alkaloid for a neuropsychiatric condition”, and “obtaining a second ASL scan of the patient’s brain post-treatment” form extra-solution activity of mere data gathering. Therefore, all of these claimed elements are not sufficient to improve the functioning of a diagnostic device or form of technology. Furthermore, while directed to activity for medical diagnostics, the claimed steps do not effect a particular treatment or prophylaxis for a disease or medical condition as it is only claiming diagnostic measurement steps and not altering a particular treatment in any way.
Step 2B Analysis (Claim 17): The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional recited elements of “obtaining a first arterial spin labeling (ASL) scan of a patient’s brain pre-treatment with an iboga-alkaloid for a neuropsychiatric condition”, and “obtaining a second ASL scan of the patient’s brain post-treatment” form extra-solution activity of mere data gathering. The limitations do not include improvements to the functioning of a computer or to any other technology or technical field, and the elements of the claim further do not effect a particular treatment or prophylaxis for a disease or medical condition. Furthermore, there are no claimed features that provide elements to identify improvements to general computing technologies based on the claimed features. As discussed above, any limitations form insignificantly extra-solution activity, and link the judicial exception to generic medical diagnostics.
Dependent claim 18 includes limitations that are directed to re-treating a patient based upon a treatment fail determination and a determination about rCBF in the left orbitofrontal cortex. This narrows the mental processing abstract idea of the independent claim and also includes a limitation to treatment. This limitation merely states “re-treating” without any particularity to how the treatment occurs or what type of treatment this should include. Therefore, the limitation is not considered to integrate the recited abstract ideas into a practical application because it does not form a “particular” treatment and is merely instructions to apply the exception in a generic way.
Dependent claim 19 includes limitations that are directed to re-treating a patient based upon a treatment fail determination and a determination about rCBF in brain regions. This narrows the mental processing abstract idea of the independent claim and also includes a limitation to treatment. This limitation merely states “re-treating” without any particularity to how the treatment occurs or what type of treatment this should include. Therefore, the limitation is not considered to integrate the recited abstract ideas into a practical application because it does not form a “particular” treatment and is merely instructions to apply the exception in a generic way.
Dependent claim 20 includes limitations that are directed to re-treating a patient based upon a treatment fail determination and a determination about rCBF in brain regions. This narrows the mental processing abstract idea of the independent claim and also includes a limitation to treatment. This limitation merely states “re-treating” without any particularity to how the treatment occurs or what type of treatment this should include. Therefore, the limitation is not considered to integrate the recited abstract ideas into a practical application because it does not form a “particular” treatment and is merely instructions to apply the exception in a generic way.
Response to Arguments
Applicant's arguments filed 2/27/2026 have been fully considered but they are not persuasive. Responses to each of the applicant’s arguments are detailed below.
Regarding the applicant’s arguments on page 9 of the remarks, the applicant argues that measuring rCBF on a normalized individual level from ASL scan data requires computational processing that cannot be reasonably performed within the mind. In the current interpretations in the rejections above, broad analysis of dynamic changes in cerebral blood flow could be reasonably performed within the human mind, once the magnetic resonance image data is received (which falls into extra solution activity of mere data gathering). The normalized individual level calculation in the present amendment is considered to be within an abstract idea of mathematical calculations. One of ordinary skill in the art would determine that the arterial spin labeling scans in itself, once acquired, would be sufficient to provide enough visual data that a human could reasonably make determinations that form “measuring changes” of regional cerebral blood flow. If this image post-processing process were to be further narrowed in the claims to differentiate from comparisons readily performed within the human mind, this could provide additional limitations that would not be considered directed to an abstract idea and could potentially overcome the current rejection. For these reasons, the interpretation of the claim is that it remains directed to an abstract idea.
Regarding the applicant’s arguments on pages 9-10 of the remarks, the applicant argues that assuming an abstract idea is recited within the claim, it would also be integrated into a practical application by effecting a particular treatment or prophylaxis for a disease or medical condition. The applicant argues that recitation of verifying a treatment and determining whether a treatment has succeeded or failed is a necessary component of the treatment process and therefore has direct therapeutic consequences for the patient. The applicant argues that this forms particular integration into a practical application of a particular treatment. In the current rejections above, it is considered that the recited limitations in the independent claims as argued by the applicant fail to incorporate the recited abstract ideas into the practical application of effecting a particular treatment or prophylaxis for a disease or medical condition. In the MPEP § 2106.04(d)(2), intended use of a treatment without positive recitation of the treatment step is not sufficient to incorporate the abstract idea into a practical application. In this instance, the verification and determination steps do not alter a particular treatment in any way and merely form tangential determinations related to a treatment generally. A treatment can occur, the determination can then be made, but the claims require no additional effecting of a particular treatment based upon the determination. There are no additional steps in the independent claims that modify the treatment based upon the recited judicial exception, merely that a previously performed treatment (extra-solution activity required to gather data for the mental analysis) is verified based upon acquired arterial spin labeling scans.
The applicant further argues that the claims constitute an improvement to the technical field of treatment for iboga alkaloids, but measuring rCBF by comparing first and second scans of a brain does not meaningfully change how treatment occurs. No adjustment of treatment is positively recited, and therefore the technical field of the claim is not iboga alkaloid treatment but rather arterial spin labeling regional cerebral blood flow imaging. In that field, no additional limitations change how the process of imaging occurs and therefore does not form an improvement to the technical field such as improving image quality, improving imaging speed, or achieving higher resolution or targeting of particular signals. For these reasons, the applicant’s arguments directed to the independent claims are not persuasive.
The applicant further argues on pages 10-11 that the dependent claims recitations of “re-treating the patient’ are sufficient to affirmatively apply the determination to effect a particular treatment. The current interpretation of these limitations is that “re-treating the patient” is too broad to be interpreted as a particular treatment (see MPEP § 2106.04(d)(2) “The Particularity of Generality of the Treatment or Prophylaxis”). The limitation doesn’t specify that a re-treatment is of iboga-alkaloid and also does not specify a particular form of treatment modification based upon the determination. Therefore, “re-treating” could be reasonably concluded to refer to any and all forms of treatment for a patient and is not considered to be particular treatment. Examiner notes that if supported by the originally filed specification, providing additional limitations to narrow “re-treating” to a more particular treatment of iboga-alkaloids based upon the determination of treatment success in the independent claim would incorporate the recited abstract ideas into a practical application and overcome the current rejections.
For these reasons, the applicant’s arguments have been considered but are not persuasive.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Crawford et al. (U.S. Pub. No. 20210251982) teaches to a method for treating or preventing neurological symptoms of disorders.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN A FRITH whose telephone number is (571)272-1292. The examiner can normally be reached M-Th 8:00-5:30 Second Fri 8:00-4:30.
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/SEAN A FRITH/Primary Examiner, Art Unit 3798
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