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 .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. GB2101229.9, filed on January 29, 2021.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on February 23, 2026 has been entered.
Response to Amendment
In the amendment filed on February 23, 2026, the following has occurred: claim(s) 1, 9 have been amended. Now, claim(s) 1-17 are pending.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “a memory module”, “a communication module”, “the memory module configured for…” in claim 1, and “a memory module”, “a communication module”, “the memory module configured for…” in claim 9.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claim(s) 1-17 is/are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claims 1-8: Step 2A Prong One
Claim 1 recites:
collecting bibliographic and physiological information from the at least one subject;
storing the collected bibliographic and physiological information;
providing stimulation associated with at least two different types of interventions to the at least one subject; and
divide a group of subjects into sub-groups and blocks, generating randomization files for applying various types of interventions to the sub-groups within the blocks;
apply at least one intervention from the at least two different types of interventions to the one or more subjects, wherein the type of intervention delivered in accordance with relevant instructions is decided on automatically in accordance with the randomization files,
wherein the system is configured to implement trials capable of achieving unbiased blinding equivalent to a double-blinded placebo-controlled trial, and
generate a plurality of virtual barriers between participants and other trial personnel to block exchange of information regarding the type of intervention delivered
These limitations, as drafted, given the broadest reasonable interpretation, but for the recitation of generic computer components, encompass managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions), which is a subgrouping of Certain Methods of Organizing Human Activity. That is, other than reciting, “an input device, a memory module, a stimulation arrangement, and a data processing arrangement are communicably coupled via a communication module”, “wherein the randomization files comprise a set of files including associated information between the bibliographic information and types of interventions generated using the at least one randomization algorithm” to perform these functions, nothing in the claim precludes the limitations from practically being performed by a research assistant or a person supervising an investigative or experimental study. Further claim 2 recites “a monitoring device”, claim 7 recites “a sensing arrangement”. For example, the claims encompass a person following instructions to collect bibliographic and physiological information from the at least one of subject, a person following instructions to store the collected bibliographic and physiological information, a person following instructions to provide stimulation associated with at least two different types of interventions to the at least one subject, a person following instructions to divide a group of subjects into sub-groups and blocks, a person following instructions to determine randomization files for one or more subjects, a person following instructions to applying at least one intervention from the at least two different types of interventions to the one or more subjects and implement trials capable of achieving unbiased blinding equivalent to a double-blinded placebo-controlled trial, and a person following instructions to generate a plurality of virtual barriers between participants and other trial personnel.
Claims 2-8 incorporate the abstract idea identified above and recite additional limitations that expand on the abstract idea, but for the recitation of generic computer components. For example, claim 2 includes the abstract idea identified above and describes restricting another person’s access to the data until completion of the investigative or experimental study. Similarly, claims 3-5 include the abstract idea identified above and further describe the generic computer components. Similarly, claim 6 includes the abstract idea identified above and further describes a person controlling a generic computer component. Similarly, claim 7 includes the abstract idea identified above and describes measuring at least one parameter to ensure a correct execution. Finally, claim 8 includes the abstract idea identified above and further describes the interventions. Such steps encompass Certain Methods of Organizing Human Activity.
Claims 1-8: Step 2A Prong Two
This judicial exception is not integrated into a practical application because the remaining
elements amount to no more than general purpose computer components programmed to perform the abstract idea, and generally linking the abstract idea to a technical environment.
Claims 1-8, directly or indirectly, recite the following generic computer components claim 1 recites “an input device, a memory module, a stimulation arrangement, and a data processing arrangement are communicably coupled via a communication module”, “wherein the randomization files comprise a set of files including associated information between the bibliographic information and types of interventions generated using the at least one randomization algorithm”, claim 2 recites “a monitoring device”, claim 7 recites “a sensing arrangement” (i.e., “Optionally, the input device includes at least one of a smartphone, a computer (can be personal, cloud-based, distributed or a tablet computer), a smart-watch, a remote control, a medical device, and so forth. Beneficially, the input devices provide a better interaction with the subject through a user-friendly interface. Additionally, the input devices enable the subject to answer the questions asked by the intervention system, in real time manner. Throughout the present disclosure, the term "memory module" as used herein relates to a volatile or persistent medium, such as an electrical circuit, magnetic disk, virtual memory or optical disk, in which a computer and/or a data processing arrangement may store data for any duration. Optionally, the memory module may be a non-volatile mass storage such as physical storage media. Throughout the present disclosure, the term "stimulation arrangement" as used herein relates to an arrangement for providing at least two different types of any form of intervention, including but not limited to audio stimulation, visual stimulation, electrical or electromagnetic stimulation, request to perform a test or an exercise, and dispensation of substances, for the purposes of experimental or investigative study to the at least one subject” in Specification on p. 11) As set forth in the 2019 Eligibility Guidance, 84 Fed. Reg. at 55 "merely include[ing] instructions to implement an abstract idea on a computer" is an example of when an abstract idea has not been integrated into a practical application.
Additionally, the claims recite “apply at least one randomization algorithms”, “wherein the system is configured to”, “wherein the stimulation arrangement comprises a headwear arrangement including a plurality of hybrid electrodes, wherein the plurality of hybrid electrodes are configured to detect electrical signals generated by the brain of the at least one subject and provide electrical stimulation to the neurons in the brain of the at least one subject” at a high degree of generality, amount no more than generally linking the abstract idea to a particular technical environment. The recitation is also similar to adding the words “apply it” to the abstract idea. As set forth in MPEP 2106.05(f), merely reciting the words “apply it” or an equivalent, is an example of when an abstract idea has not been integrated into a practical application.
Claims 1-8: Step 2B
The claim(s) does/do not include additional elements that are sufficient to amount to
significantly more than the judicial exception. As discussed above with respect to integration of
the abstract idea into a practical application, the additional elements of using a computer
configured to perform above identified functions amounts to no more than mere instructions to
apply the exception using generic computer components. Mere instructions to apply an exception
using a generic computer component cannot provide an inventive concept. See Alice 573 U.S. at
223 ("mere recitation of a generic computer cannot transform a patent-ineligible abstract idea
into a patent-eligible invention.")
Additionally, generally linking the abstract idea to a particular technological environment
does not amount to significantly more than the abstract idea (See MPEP 2016.05(h) and Affinity
Labs of Texas v. DirectTV, LLC, 838 F.3d 1253, 120 USP12d 1201 (Fed. Cir. 2016)).
Claims 9-16 and 17 recite the same functions as claims 1-8, but in method and computer program product form.
The addition of “a computer programme product comprising a non-transitory computer- readable storage medium having computer-readable instructions stored thereon, the computer-readable instructions being executable by a computerised device comprising processing hardware to execute” in claim 17 amount to no more than general purpose computer components programmed to perform the abstract idea. (“Optionally, the input device includes at least one of a smartphone, a computer (can be personal, cloud-based, distributed or a tablet computer), a smart-watch, a remote control, a medical device, and so forth. Beneficially, the input devices provide a better interaction with the subject through a user-friendly interface. Additionally, the input devices enable the subject to answer the questions asked by the intervention system, in real time manner.” in Specification on p. 11)
Therefore, whether considered alone or in combination, the additional elements do not
amount to significantly more than the abstract idea.
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 1-3, 6-7, 9-11, 14-15, 17 are rejected under 35 U.S.C. 103 as being unpatentable over Finken et al. (U.S. Patent Pre-Grant Publication No. 2016/0125171) in view of Howard (U.S. Patent Pre-Grant Publication No. 2019/0381314) in further view of Foster et al. (U.S. Patent Pre-Grant Publication No. 2020/0411141).
As per independent claim 1, Finken discloses an intervention system that, when in operation, automatically performs unbiased testing of at least one subject under investigative or experimental study, wherein an input device (See Paragraph [0079]: A system or any portion thereof may be a personal computer (e.g., desktop or laptop), tablet computer, mobile device (e.g., personal digital assistant (PDA) or smart phone), server (e.g., blade server or rack server), a network storage device, or any other suitable device or combination of devices and may vary in size, shape, performance, functionality, and price, which the Examiner is interpreting a personal computer to encompass an input device), a memory module (See Paragraphs [0020]-[0021]: The clinical trial manager may allow for the planning or setup of a new clinical trial, data collection and data management during a clinical trial, and real-time data review and analysis during and after a clinical trial, which the Examiner is interpreting the clinical trial database to encompass a memory module), a stimulation arrangement, and a data processing arrangement are communicably coupled via a communication module, wherein the system comprises:
(i) the input device configured for collecting bibliographic and physiological information from the at least one subject (See Paragraphs [0020]-[0021], [0025]-[0027], [0065]: The clinical trial manager may allow for the planning or setup of a new clinical trial, data collection and data management during a clinical trial, and real-time data review and analysis during and after a clinical trial, which the Examiner is interpreting data collection to encompass collecting bibliographic and physiological information from the at least one subject as the database stores various information related to one or more clinical trial studies, such as but not limited to participant and patient data, enrollment data, study data, or user data for example ([0021]));
(ii) the memory module configured for storing the collected bibliographic and physiological information (See Paragraphs [0020]-[0021]: The clinical trial manager may allow for the planning or setup of a new clinical trial, data collection and data management during a clinical trial, and real-time data review and analysis during and after a clinical trial, which the Examiner is interpreting the clinical trial database to encompass a memory module.)
While Finken teaches the system described above, Finken may not explicitly teach (iii) the stimulation arrangement configured for providing stimulation associated with at least two different types of interventions to the at least one subject, wherein the stimulation arrangement comprises a headwear arrangement including a plurality of hybrid electrodes, wherein the plurality of hybrid electrodes are configured to detect electrical signals generated by the brain of the at least one subject and provide electrical stimulation to the neurons in the brain of the at least one subject;
(iv) the data processing arrangement configured to:
(b) operate the stimulation arrangement to apply at least one intervention from the at least two different types of interventions to the one or more subjects, in accordance with the randomization files generated by the data processing arrangement,
wherein the type of intervention delivered in accordance with relevant instructions is decided on automatically in accordance with the randomization files,
wherein the system is configured to implement trials capable of achieving unbiased blinding equivalent to a double-blinded placebo-controlled clinical trial, and
wherein the system is configured to generate a plurality of virtual barriers between participants and other trial personnel to block exchange of information regarding the type of intervention delivered.
Howard teaches a system for (iii) the stimulation arrangement configured for providing stimulation associated with at least two different types of interventions to the at least one subject (See Paragraphs [0044]-[0047]: Earbuds may provide tVNS stimulation and measure neurophysiology, which the Examiner is interpreting tVNS stimulation and electrical stimulation signals to encompass providing stimulation associated with at least two different types of interventions), wherein the stimulation arrangement comprises a headwear arrangement (See Paragraphs [0038]-[0039]: The helmet may include sensors to measure physical and physiological parameters such as EEG, ECG, heart rate, etc.) including a plurality of hybrid electrodes, wherein the plurality of hybrid electrodes are configured to detect electrical signals generated by the brain of the at least one subject (See Paragraphs [0038]-[0039], [0046]: The helmet may include sensors to measure physical and physiological parameters such as EEG, ECG, heart rate, etc. as the sensors and stimulators may include electrodes, contacts, etc. made from a variety of materials, including, but not limited to carbon nanotubes (CNT), graphene, etc. ([0046])) and provide electrical stimulation to the neurons in the brain of the at least one subject (See Paragraphs [0038]-[0039], [0044]-[0047]: In embodiments, sensors and stimulators may include electrodes, contacts, etc. made from a variety of materials, including, but not limited to carbon nanotubes (CNT), graphene, etc., and the wireless communication unit 204 may perform functions such as the access protocol, security/firewall, connect to app, data transfer, receive control from app, connect to TENS unit 205, send stimuli to patches, receive data from patches, etc. TENS unit 205 may provide electrical stimulation signals that may provide therapeutic benefit on pain, which the Examiner is interpreting TENS unit may provide electrical stimulation signals to encompass provide electrical stimulation to the neurons in the brain of the at least one subject);
(iv) the data processing arrangement configured to:
(b) operate the stimulation arrangement to apply at least one intervention from the at least two different types of interventions to the one or more subjects, in accordance with the randomization files generated by the data processing arrangement (See Paragraphs [0126]-[0128]: Embodiments may use a combination of two non-invasive peripheral stimulations (tVNS and TENS); three different task domains (motor, cognitive flexibility and linguistic), heavily reliant on predictive inference and/or error-processing skills, across a range of varying levels of difficulty and different training and stimulation protocols, which the Examiner is interpreting the stimulation protocols to encompass the randomization files),
wherein the type of intervention delivered in accordance with relevant instructions is decided on automatically in accordance with the randomization files (See Paragraphs [0043], [0186]-[0188]: tVNS and TENS stimulation will be administered at this point within the initial seconds of each trial (familiarization phase) prior to agent (session 1) or question/test stimuli (sessions 2 & 3), which the Examiner is interpreting stimulation to encompass relevant instructions is decided on automatically in accordance with the randomization files (Paragraph [0043]: Subject profiles may be analyzed against each other to mine for patterns)),
wherein the system is configured to implement trials capable of achieving unbiased blinding equivalent to a double-blinded placebo-controlled clinical trial (See Paragraphs [0196]-[0197]: Stimulation will be administered in a double-blind fashion), and
wherein the system is configured to generate a plurality of virtual barriers between participants and other trial personnel to block exchange of information regarding the type of intervention delivered (See Paragraphs [0047], [0197], [0216]: Wireless communication unit may perform functions such as the access protocol, security/firewall, connect to app, data transfer, receive control from app, connect to TENS unit, which the Examiner is interpreting security/firewall to encompass generate a plurality of virtual barriers between participants and other trial personnel to block exchange of information regarding the type of intervention delivered as a firewall is a network security system that monitors and controls incoming and outgoing network traffic based on configurable security rules.)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed to modify the system of Finken to include (iii) the stimulation arrangement configured for providing stimulation associated with at least two different types of interventions to the at least one subject, wherein the stimulation arrangement comprises a headwear arrangement including a plurality of hybrid electrodes, wherein the plurality of hybrid electrodes are configured to detect electrical signals generated by the brain of the at least one subject and provide electrical stimulation to the neurons in the brain of the at least one subject; (iv) the data processing arrangement configured to: (b) operate the stimulation arrangement to apply at least one intervention from the at least two different types of interventions to the one or more subjects, in accordance with the randomization files generated by the data processing arrangement, wherein the type of intervention delivered in accordance with relevant instructions is decided on automatically in accordance with the randomization files, wherein the system is configured to implement trials capable of achieving unbiased blinding equivalent to a double-blinded placebo-controlled clinical trial, and wherein the system is configured to generate a plurality of virtual barriers between participants and other trial personnel to block exchange of information regarding the type of intervention delivered as taught by Howard. One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Finken with Howard with the motivation of enhancing the speed and quality of cognitive brain function (See Background of Howard in Paragraph [0004]).
Finken/Howard teaches the system as described above, Finken/Howard may not explicitly teach (iv) the data processing arrangement configured to:
(a) apply at least one randomization algorithm to divide a group of subjects into sub-groups and blocks, generating randomization files for applying various types of interventions to the sub-groups within the blocks, wherein the randomization files comprise a set of files including associated information between the bibliographic information and types of interventions generated using the at least one randomization algorithm.
Foster teaches a system for (iv) the data processing arrangement configured to:
(a) apply at least one randomization algorithm to divide a group of subjects into sub-groups and blocks (See Paragraphs [0073]-[0074], [0081]: The patient information engine may implement one or more automated agents configured to access, sort, and display patient health data pertaining to patients that may be eligible for enrollment and participation in ongoing and upcoming clinical trials, which the examiner is interpreting the patient information engine to encompass apply at least one randomization algorithm, and the list of potential patients can be a subset of all patients that receive medical care at the clinical site to encompass divide a group of subjects into sub-groups and blocks), generating randomization files for applying various types of interventions to the sub-groups within the blocks (See Paragraph [0088]: The patient health data may comprise any information relating to the patient including patient health, disease state, age, gender, geographic location, treatment type, symptoms, disease progression, other relevant diseases, physician notes, and billing codes relating to disease diagnosis and treatment, which the Examiner is interpreting the patient health data to encompass randomization files, and treatment type to encompass types of interventions), wherein the randomization files comprise a set of files including associated information between the bibliographic information and types of interventions generated using the at least one randomization algorithm (See Paragraph [0112]: The filter engine may filter and/or narrow or expand a potential pool from the patient data, the inclusion/exclusion criteria can include filtering a patient population by disease type, disease progression, treatment type, age, gender, geographic location, proximity to clinical sites, outcomes, and even key word searches from within medical/doctor notes in the patient's medical file, which the Examiner is interpreting medical/doctor notes to encompass bibliographic information, and treatment type to encompass types of interventions);
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed to modify the system of Finken/Howard to include (iv) the data processing arrangement configured to: (a) apply at least one randomization algorithm to divide a group of subjects into sub-groups and blocks, generating randomization files for applying various types of interventions to the sub-groups within the blocks, wherein the randomization files comprise a set of files including associated information between the bibliographic information and types of interventions generated using the at least one randomization algorithm as taught by Foster. One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Finken/Howard with Foster with the motivation of improved data management (See Background of Foster in Paragraph [0005]).
Claim(s) 9 and 17 mirror claim 1 only within different statutory categories, and are rejected for the same reasons as claim 1.
As per claim 2, Finken/Howard/Foster discloses the system of claim 1 as described above. Finken further teaches wherein the system comprises a monitoring device having a secured access that, when in operation, restricts user access to prevent unblinding of data of a user to another until completion of the investigative or experimental study (See Paragraphs [0066]-[0068]: The clinical trial manager may allow only an authenticated user to access the system and data associated with that user's information, and the clinical trial manager may make note of which user type is accessing the system and allow access to one or more user access areas, which the Examiner is interpreting the clinical manager allow access areas to encompass a monitoring device having a secured access that, when in operation, restricts user access to prevent unblinding of data of a user to another until completion of the investigative or experimental study as users can be restricted access to levels ([0067]: A user may be granted access to all levels lower than the access level assigned to them).)
Claim(s) 10 mirrors claim 2 only within a different statutory category, and is rejected for the same reasons as claim 2.
As per claim 3, Finken/Howard/Foster discloses the system of claim 1 as described above. Finken further teaches wherein the randomization files assign two different interventions to the at least one subject undergoing multiple interventions (See Paragraphs [0030]-[0043]: A user may contact participants and may ask one or more objective and/or subjective questions, if a negative experience or observation is detected, an intervention may be recorded, data may be sent to the documentation routine, and the data analysis engine may determine which steps to take next, which the Examiner is interpreting user may contact participants and may ask one or more objective and/or subjective questions to encompass assign two different interventions to the at least one subject undergoing multiple interventions.)
Claim(s) 11 mirrors claim 3 only within a different statutory category, and is rejected for the same reasons as claim 3.
As per claim 6, Finken/Howard/Foster discloses the system of claim 1 as described above. Finken further teaches wherein an intensity of intervention provided from the stimulation arrangement is controlled by a person using the system (See Paragraphs [0043]-[0044], [0053]-[0054]: Interventions may be ranked according to their severity, and study markers or keywords thus may encompass severity levels of interventions, which the Examiner is interpreting interventions may be ranked according to their severity to encompass an intensity of intervention, and communication may be established by the clinical trial manager, user, or participant when side effects such as nausea, hypoglycemia, hyperglycemia, bruising, headaches, changes in blood pressure or vision, or any other symptoms occur or fail to remedy to encompass the stimulation arrangement is controlled by a person using the system.)
Claim(s) 14 mirrors claim 6 only within a different statutory category, and is rejected for the same reasons as claim 6.
As per claim 7, Finken/Howard/Foster discloses the system of claim 1 as described above. Finken further teaches wherein the system comprises a sensing arrangement that, when in operation, measures at least one parameter required to ensure a correct execution of the investigative or experimental study on the at least one subject (See Paragraphs [0053]-[0054], [0067]-0070]: The patient may enter objective or subjective responses to study protocols specific to the patient, make additional notes as warranted, or update some patient information, which the Examiner is interpreting the patient may enter objective or subjective responses to study protocols specific to the patient to encompass measures at least one parameter required to ensure a correct execution of the investigative or experimental study on the at least one subject as interventions can include misunderstanding the directions for taking a compound ([0053]) this misunderstanding would be corrected by communicating with the patient to take the compound so to follow the clinical instructions ([0048]).)
Claim(s) 15 mirrors claim 7 only within a different statutory category, and is rejected for the same reasons as claim 7.
Claims 4-5, 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Finken et al. (U.S. Patent Pre-Grant Publication No. 2016/0125171) in view of Howard (U.S. Patent Pre-Grant Publication No. 2019/0381314) in view of Foster et al. (U.S. Patent Pre-Grant Publication No. 2020/0411141) in further view of Sillay et al. (U.S. Patent Pre-Grant Publication No. 2014/0257047).
As per claim 4, Finken/Howard/Foster discloses the system of claim 1 as described above. Finken/Howard/Foster may not explicitly teach wherein the data processing arrangement further analyses the physiological information collected from the at least one subject, before and after the intervention.
Sillay teaches a system wherein the data processing arrangement further analyses the physiological information collected from the at least one subject, before and after the intervention (See Paragraphs [0153]-[0154]: It is desirable that objective measures (OM) data be collected on a regular or periodic basis (FIG. 107), either by the individual with disease or with the assistance of a caregiver, or in a clinical setting, and that the collected OM data be analyzed (FIG. 92) to determine long-term trends in the efficacy of treatment or disease progress or to compare the OM data acquired from one or a group of individuals diagnosed with a disease to another group of individuals diagnosed with a disease using statistical analysis, which the Examiner is interpreting OM data be collected on a regular or periodic basis to encompass analyses the physiological information collected from the at least one subject, before and after the intervention.)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed to modify the system of Finken/Howard/Foster to include the data processing arrangement further analyses the physiological information collected from the at least one subject, before and after the intervention as taught by Sillay. One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Finken/Howard/Foster with Sillay with the motivation of improving the health of the people in a selected population by quantifying results of health care intervention (See Detailed Description of Sillay in Paragraph [0237]).
Claim(s) 12 mirrors claim 4 only within a different statutory category, and is rejected for the same reasons as claim 4.
As per claim 5, Finken/Howard/Foster discloses the system of claim 1 and Finken/Howard/Foster/Sillay discloses the system of claim 4 as described above. Finken/Howard/Foster may not explicitly teach wherein the data processing arrangement performs a second intervention to the at least one subject, based on the physiological information.
Sillay teaches a system wherein the data processing arrangement performs a second intervention to the at least one subject, based on the physiological information (See Paragraphs [0169]-[0170], [0177]-[0180]: A feedback path or an alarm path to the individual with disease, for example, is provided to trigger to begin a Sillay test at home, to take a prescribed medication at a particular level by comparison of medication taken by the individual with disease with cohort data or to provide real time control of DBS or neurostimulation and/or a drug regimen, which the Examiner is interpreting take a prescribed medication at a particular level by comparison of medication taken by the individual with disease with cohort data to encompass the data processing arrangement performs a second intervention to the at least one subject, based on the physiological information as Finken discloses in Paragraphs [0030]-[0043]: A user may contact participants and may ask one or more objective and/or subjective questions, if a negative experience or observation is detected, an intervention may be recorded, data may be sent to the documentation routine, and the data analysis engine may determine which steps to take next.)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed to modify the system of Finken/Howard/Foster to include the data processing arrangement performs a second intervention to the at least one subject, based on the physiological information as taught by Sillay. One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Finken/Howard/Foster with Sillay with the motivation of improving the health of the people in a selected population by quantifying results of health care intervention (See Detailed Description of Sillay in Paragraph [0237]).
Claim(s) 13 mirrors claim 5 only within a different statutory category, and is rejected for the same reasons as claim 5.
Claims 8 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Finken et al. (U.S. Patent Pre-Grant Publication No. 2016/0125171) in view of Howard (U.S. Patent Pre-Grant Publication No. 2019/0381314) in view of Foster et al. (U.S. Patent Pre-Grant Publication No. 2020/0411141) in further view of Wetmore et al. (U.S. Patent Pre-Grant Publication No. 2012/0251989).
As per claim 8, Finken/Howard/Foster discloses the system of claim 1 as described above. Finken/Howard/Foster may not explicitly teach wherein the intervention is selected from a group of electrical, magnetic, audio, visual, light, ultrasound and binaural beats stimulation or any combination thereof.
Wetmore teaches a system wherein the intervention is selected from a group of electrical, magnetic, audio, visual, light, ultrasound and binaural beats stimulation or any combination thereof (See Paragraphs [0120], [0126]-[0127]: The choice of sensory stimulus and/or its intensity and/or its rate of repetition can be adjusted based on the level of arousal of the user during sleep, the stimuli are typically capable of activating one or more of a user's auditory, somatosensory, olfactory, gustatory, visual, vestibular, or other sensory systems, examples of stimulus generating elements include a screen or light, speaker, tactile electrical or mechanical stimulator, or scent-releasing device, which the Examiner is interpreting the stimuli to encompass the intervention is selected from a group of electrical, magnetic, audio, visual, light, ultrasound and binaural beats stimulation or any combination thereof.)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed to modify the system of Finken/Howard/Foster to include the intervention is selected from a group of electrical, magnetic, audio, visual, light, ultrasound and binaural beats stimulation or any combination thereof as taught by Wetmore. One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Finken/Howard/Foster with Wetmore with the motivation of improving the lives of those with intellectual disabilities, age-related cognitive decline, and other forms of learning disability by improving memory and cognitive function (See Background of Wetmore in Paragraph [0008]).
Claim(s) 16 mirrors claim 8 only within a different statutory category, and is rejected for the same reasons as claim 8.
Response to Arguments
In the Remarks filed on February 23, 2026, the Applicant argues that the newly amended and/or added claims overcome the Claim Interpretation(s), 35 U.S.C. 101 rejection(s), and 35 U.S.C. 103 rejection(s). The Examiner does not acknowledge that the newly added and/or amended claims overcome the Claim Interpretation(s), 35 U.S.C. 101 rejection(s), and 35 U.S.C. 103 rejection(s).
The Applicant argues that:
(1) Applicant respectfully submits that the amended claims are not directed to organizing human activity that can be performed manually by clinical trial personnel. The claims recite specific technical operations that require automated computer-controlled hardware. The claims require a system comprising a headwear arrangement including a plurality of hybrid electrodes configured to detect electrical signals generated by neurons in the brain and provide electrical stimulation to the neurons in the brain. This operation requires specialized medical device hardware with bidirectional communication capabilities that cannot be replicated through manual clinical trial procedures. The claims also require that the system generates a plurality of virtual barriers between participants and other trial personnel to block exchange of information regarding the type of intervention delivered. These virtual barriers represent technical security architecture implemented through the system's communication pathways. The virtual barriers prevent information about intervention assignments from being transmitted between the participant and trial personnel by controlling data flow through the system architecture. Generating multiple simultaneous virtual barriers that selectively block specific categories of information while allowing other data to flow requires computer-implemented access controls and network architecture that cannot be replicated through manual procedures. A human clinical coordinator cannot generate virtual barriers in a computer system through mental steps. The claims further require automated randomization where the type of intervention delivered is decided on automatically in accordance with randomization files without human decision-making during intervention delivery. The data processing arrangement must apply randomization algorithms to divide subjects into sub-groups and blocks, generate randomization files encoding the assignments, and automatically operate the stimulation arrangement to deliver interventions according to those files. This automation of intervention delivery based on algorithmically generated assignments requires computer processing and cannot be performed manually. The data processing arrangement acts as a central element where all signals between the input device and stimulation arrangement pass through the data processing arrangement. This centralized architecture with automated signal routing and intervention control requires computer hardware and cannot be reduced to manual clinical procedures. Under MPEP 2106.04(a)(2), a claim is not directed to organizing human activity if it requires technical operations that cannot practically be performed through manual organizational procedures. The combination of hybrid electrodes performing bidirectional neural communication, virtual barriers implemented through computer security architecture, and automated intervention delivery based on randomization algorithms all require computer hardware and medical device technology that cannot be replicated through manual clinical trial procedures. Applicant respectfully submits that the combination of hybrid electrodes as specialized medical device hardware, virtual barriers as computer-implemented security architecture, and automated randomization-based intervention control creates a technical system that requires computer and medical device technology and cannot be reduced to manual organizational steps. In view of the foregoing remarks, Applicant respectfully submits that amended independent claims 1 and 9 are not directed to an abstract idea under Prong One of Step 2A;
(2) Applicant respectfully submits that the claims involve more than routine or conventional activities and integrate the judicial exception into a practical application. The claimed invention introduces an unconventional approach to conducting clinical trials by using cloud-connected automated intervention systems that eliminate the need for human intermediaries in intervention delivery and blinding maintenance. Existing clinical trial systems face significant technical challenges. Conventional systems that use pre-set codes to deliver interventions still involve a clinician who receives the code and passes it to the patient because there is no direct communication between the device and the cloud. These systems cannot automate the blinding process or implement adaptive trial designs because the device is not connected to the cloud and the clinician is the only means of communication between the device and the trial organizer. The claimed invention overcomes these technical problems through an unconventional architecture. Rather than relying on human intermediaries to maintain blinding and deliver interventions, the system uses hybrid electrodes for automated bidirectional brain communication combined with virtual barriers that prevent information leakage between participants and trial personnel. This enables intervention delivery and data collection without human involvement that could compromise blinding. The hybrid electrode configuration provides technical advantages over conventional approaches. The plurality of electrodes are hybrid electrodes which can function both for EEG recording and electrical stimulation. This dual functionality means the same electrodes that detect brain activity signals can deliver therapeutic stimulation, eliminating the need for separate recording and stimulation hardware. The hybrid electrodes enable real-time monitoring of brain responses during intervention delivery, allowing the system to collect physiological data and deliver interventions through the same hardware interface. The virtual barrier architecture provides technical security that was not achievable in prior clinical trial systems. The system generates a plurality of virtual barriers between participants and trial personnel to block exchange of information. These virtual barriers represent computer-implemented access controls that prevent trial personnel from accessing information about which intervention type was delivered to each participant. This is unconventional because prior systems required clinicians to be involved in the intervention delivery process, making true blinding impossible. The automated intervention delivery based on randomization files represents an unconventional implementation. The data processing arrangement generates randomization files that encode intervention assignments for subjects divided into sub-groups and blocks, then automatically operates the stimulation arrangement to deliver the assigned intervention without requiring human decision-making. This automation eliminates the human intermediary that conventional systems required, as described in the specification background. The integration of hybrid electrodes with automated randomization and virtual barriers represents an unconventional combination. The hybrid electrodes provide the hardware interface for automated intervention delivery. The randomization files provide the algorithmic control that determines which intervention each subject receives. The virtual barriers provide the security architecture that maintains blinding by preventing information flow to trial personnel. These three elements work together to enable fully automated, blinded intervention delivery that was not possible with prior systems that required human intermediaries. The system significantly improves the reliability and integrity of clinical trial blinding. Since the generation of randomization files and intervention delivery does not involve doctors or other third parties, the system achieves the same result as a gold standard double-blinded placebo-controlled trial with negligible additional costs. The virtual barriers ensure that even if data is accessed before trial completion, the blinding is not compromised because the barriers prevent information about intervention assignments from reaching trial personnel. Under MPEP 2106.05(a), an improvement to computer functionality or to another technology or technical field may integrate a judicial exception into a practical application. The claimed invention improves medical device technology by providing an unconventional method for conducting intervention trials that avoids the technical limitations of conventional systems that required human intermediaries. This improvement addresses a problem specifically arising in computer-networked medical devices, similar to the internet-specific problem addressed in DDR Holdings, LLC v. Hotels.com, L.P., 773 F.3d 1245 (Fed. Cir. 2014). Existing systems are not able to automate the blinding process because there is no direct communication between the device and the cloud. The claimed invention solves this technical problem by providing cloud-connected architecture with automated intervention delivery through hybrid electrodes and information security through virtual barriers. This represents a technological solution to a technological problem in networked medical device systems. In view of the foregoing remarks, Applicant respectfully submits that amended independent claims 1 and 9, as a whole, integrate the purported abstract idea into a practical application under Prong Two of Step 2A;
(3) Applicant respectfully submits that the claims include additional elements that amount to significantly more than the judicial exception. The claimed invention provides specific improvements to medical device technology through the hybrid electrode hardware and virtual barrier security architecture. The hybrid electrodes provide a technical improvement in how medical devices interface with the brain for intervention delivery. This hardware configuration provides concrete technical benefits. By using the same electrodes for both recording and stimulation, the system eliminates the need for separate electrode arrays and reduces the complexity of the headwear arrangement. The hybrid electrodes enable real-time monitoring of brain activity during intervention delivery, allowing the system to collect physiological data that can be used for adaptive trial designs. This represents a specific hardware implementation that improves medical device functionality. The virtual barrier architecture provides technical improvements in how networked medical device systems maintain data security and trial integrity. The system generates a plurality of virtual barriers between participants and trial personnel to block exchange of information regarding the type of intervention delivered. These virtual barriers represent computer-implemented access controls that are integrated into the system architecture to prevent information leakage. The virtual barriers provide technical security that goes beyond conventional access controls. Unlike simple password protection, the virtual barriers are designed to maintain trial blinding by preventing trial personnel from accessing specific categories of information even if they have general system access. The barriers must allow trial personnel to monitor participant safety and collect outcome data while preventing them from learning which intervention type each participant received. This selective information blocking requires sophisticated access control logic integrated into the system's data flow architecture. The automated intervention delivery mechanism provides technical improvements in how medical devices execute protocol-driven procedures. The data processing arrangement must generate randomization files that encode complex assignment logic for dividing subjects into sub-groups and blocks, then automatically operate the stimulation arrangement based on those files. The data processing arrangement acts as a central element where all signals transmitted between the input device and stimulation arrangement pass through the data processing arrangement. This centralized control architecture enables the system to enforce the randomization protocol without human intervention. The claimed invention provides a practical solution for a specific problem in medical device technology. The problem is how to conduct intervention trials with proper blinding when the intervention delivery device must be operated and monitored. Conventional approaches that involve human operators in the intervention delivery process compromise blinding because the operators learn which intervention is being delivered. Even systems with pre-set codes still involve a clinician who passes the code to the patient, preventing true double-blinding. The claimed system solves this problem by using hybrid electrodes that can automatically deliver interventions and collect data without human involvement, combined with virtual barriers that prevent trial personnel from accessing intervention assignment information even when they have access to other trial data. This approach avoids the technical problems of conventional human-mediated systems while enabling proper double-blinding. The synergistic architecture integrates three key technical elements. The hybrid electrodes provide the hardware interface for automated intervention delivery and data collection. The randomization files provide the algorithmic control encoded in a standardized data structure. The virtual barriers provide the security architecture that enforces information compartmentalization. These elements work together to enable a new capability in medical device systems that was not possible with prior approaches that required human intermediaries. The claimed system is designed to operate at technological scales that require computer implementation. The system must manage intervention delivery across multiple subjects with different randomization assignments. The hybrid electrodes must handle real-time bidirectional neural communication with signal processing for artifact filtering, amplification, and stimulation generation. The virtual barriers must enforce access controls across a distributed system with multiple users and data access points. These operations require specialized medical device hardware, network architecture, and security systems that cannot be implemented manually. Unlike abstract concepts of trial organization, the claimed invention specifies how the interventions are delivered through hybrid electrodes that perform dual recording and stimulation functions. The claims specify how the trial blinding is maintained through virtual barriers that block information exchange between participants and personnel. The claims specify how the intervention assignments are controlled through automated operation of the stimulation arrangement in accordance with randomization files. The claims specify the result that must be achieved, namely implementation of trials capable of achieving unbiased blinding equivalent to a double-blinded placebo-controlled trial. These specific technical details transform the concept of trial organization into a concrete, practical application of networked medical device technology. Under MPEP 2106.05(a), improvements to the functioning of computer technology or other technology fields may provide significantly more than a judicial exception. The claimed invention improves medical device technology and networked device security. This type of improvement is analogous to those found patent eligible in Enfish, LLC v. Microsoft Corp., 822 F.3d 1327 (Fed. Cir. 2016), where claims directed to a specific data structure that improved computer database functionality were patent eligible because they were directed to an improvement in computer functionality rather than an abstract idea. The hybrid electrodes are not simply a field of use limitation. The hybrid electrode configuration provides specific technical functionality that enables the automated intervention delivery and real-time monitoring that are essential to the system's operation. Without the bidirectional communication capability of the hybrid electrodes, the system could not automatically deliver interventions while simultaneously monitoring brain responses. The dual functionality of the hybrid electrodes is integral to how the system operates, not merely the environment in which it operates. The virtual barriers are specifically defined as blocking exchange of information regarding the type of intervention delivered between participants and trial personnel. This is not generic access control. The virtual barriers must selectively block specific categories of information while allowing other data to flow. The virtual barriers prevent information exchange that would compromise trial blinding while still allowing necessary communication for safety monitoring and data collection. This selective information blocking is a specific security architecture requirement that goes beyond conventional access controls. Existing clinical trial systems cannot automate the blinding process because there is no direct communication between the device and the cloud and because they require human intermediaries. The claimed combination of hybrid electrodes, virtual barriers, and automated randomization-based intervention delivery solves this problem in a way that prior systems could not. The specification does not describe this combination as conventional. Rather, the specification describes conventional systems and explains how they fail to achieve the same result because they require human intermediaries that compromise blinding. Therefore, Applicant respectfully submits that the claimed elements go beyond organizing human activity through manual procedures by involving specialized medical device hardware with bidirectional neural communication, computer-implemented security architecture with selective information blocking, and automated intervention delivery controlled by algorithmic randomization. By relying on hybrid electrode technology, virtual barrier security architecture, and automated stimulation control, the claimed invention is integrated into a practical application of networked medical device technology. Each element contributes to a technical advancement, providing improved reliability and integrity in conducting blinded intervention trials. Accordingly, Applicant respectfully submits that amended independent claims 1 and 9 amount to "significantly more" than an abstract idea under Step 2B. In light of the above discussion, Applicant respectfully submits that amended independent claims 1 and 9 overcome the 35 U.S.C. § 101 rejection. Dependent claims 2-8 and 10-17 are also allowable at least by virtue of their respective dependencies;
(4) Applicant respectfully submits that Finken, Howard, and Foster, either alone or in combination, fails to teach or suggest: "wherein the system is configured to generate a plurality of virtual barriers between participants and other trial personnel to block exchange of information regarding the type of intervention delivered". Finken describes a computer-implemented platform for managing clinical trials that enables collection, storage, organization, and review of participant information and communications. The system provides a clinical-trial database and associated interfaces through which participants submit questionnaires, symptom reports, and other health information, and through which clinicians and investigators communicate with participants and monitor study progress. The platform further includes protocol-management and documentation routines, and allows different categories of users (e.g., clinical investigators, study personnel, and participants) to access study data and interact with one another via the system, including messaging and reporting functions. Thus, Finken is directed to coordinating clinical-trial administration, data acquisition, and oversight through a centralized database and communication infrastructure. However, Finken does not disclose a system that creates virtual barriers preventing exchange of information regarding the type of intervention delivered between participants and trial personnel. The Finken platform facilitates communication between participants and clinicians and permits investigators to review participant information and clinical-trial records, and any described access permissions relate only to database access or information management. There is no teaching that the system autonomously assigns or delivers an intervention while concealing the intervention type from treating personnel, nor that the system enforces a blinded condition by isolating treatment-allocation knowledge from individuals interacting with the participant. Accordingly, Finken lacks any disclosure of system-enforced informational isolation, i.e., the claimed plurality of virtual barriers blocking knowledge of the intervention administered. Howard describes a neuro-stimulation and monitoring platform directed to cognitive enhancement through peripheral nerve stimulation. The system includes transcutaneous nerve-stimulation circuitry (e.g., vagal nerve stimulation and transcutaneous electrical nerve stimulation) with electrodes positioned on a human subject, along with sensors (such as EEG, ECG, heart-rate and other physiological sensors) that monitor bodily and neurological conditions. The stimulation devices (ear-mounted units, wearable patches, or helmet-mounted components) communicate wirelessly with control circuitry, computing devices, and cloud-based servers, which collect, analyze, and process physiological data and may adjust stimulation parameters in a closed-loop manner based on measured responses. The system therefore concerns delivering neurostimulation, recording subject responses, and analyzing resulting data to study or enhance cognitive performance. However, Howard does not disclose a system that creates virtual barriers preventing exchange of information regarding the intervention type between participants and trial personnel. The reference is directed to administering stimulation to a subject and monitoring physiological signals, and describes control, communication, data analysis, and security for data transmission and storage. It does not describe a clinical-trial blinding architecture, concealment of treatment allocation, or a system that isolates intervention knowledge from individuals interacting with the subject. There is no teaching that treatment selection is hidden from operators or researchers, nor that the system prevents disclosure of whether a real or placebo intervention is delivered. Accordingly, Howard lacks any disclosure of system-enforced informational isolation or "virtual barriers" that block knowledge of the intervention delivered. Foster describes a computer-implemented clinical-trial selection and patient identification platform used to determine eligibility of patients for clinical studies. The system collects and aggregates medical and demographic information (e.g., diagnoses, symptoms, treatments, demographics, laboratory results, and clinical records) from electronic medical record systems and other databases and analyzes the data using a computing device to match patients to clinical trial criteria. The platform may include engines that obtain clinical data, apply inclusion and exclusion criteria, and provide physicians or coordinators with lists of eligible patients and trial information, while allowing clinicians to review and enroll patients into studies. Thus, Foster is directed to identifying, screening, and managing patient participation in clinical trials through automated data processing and eligibility determination. However, Foster does not disclose a system that creates virtual barriers preventing exchange of information regarding the type of intervention delivered between participants and trial personnel. The reference concerns identifying and enrolling patients into appropriate trials and providing clinical information to physicians and coordinators, who then interact with and manage patient enrollment. It neither administers an intervention nor conceals intervention allocation, and there is no teaching that treatment assignment is hidden from clinicians or that the system isolates treatment knowledge from individuals interacting with the patient. Accordingly, Foster lacks any disclosure of a system-enforced blinding architecture or informational isolation blocking knowledge of which intervention a participant receives. Even if Finken, Howard, and Foster are combined, a person having ordinary skill in the art would still not arrive at the claimed virtual barrier feature. Finken manages trial data and communication, Howard delivers and monitors stimulation, and Foster identifies and enrolls patients. Together they would only form a system that selects participants, provides treatment, and records study information. None of them teaches hiding the treatment assignment from the clinicians or preventing personnel interacting with the participant from knowing which intervention was given. The amended claim requires the system itself to enforce blinding by restricting access to treatment information, which is a different objective from enrollment, treatment delivery, or data management. Since the references neither recognize this problem nor suggest blocking information flow between participants and trial personnel, their combination would not lead to the virtual barrier feature of amended claim 1. At least for these reasons, Finken, Howard, and Foster, either alone or in combination, fails to teach or suggest all the features of amended claim 1 and fails to render claim 1 unpatentable. Finken, Howard, and Foster, either alone or in combination, fail to teach or suggest all the features of independent claim 9 and fails to render claim 9 unpatentable for the same reasons. Claims 2, 3, 6, 7, 10, 11, 14, 15, and 17 are also patentable at least by virtue of their respective dependencies and for the additional features they recite;
(5) claims 4, 5, 12, and 13 depend from claims 1 or 9. Sillay fails to disclose or suggest the features of claims 1 and 9 missing from the combination Finken, Howard, and Foster, and as a result, the combination Finken, Howard, Foster, and Sillay fails to render claims 4, 5, 12, and 13 unpatentable. Claims 8 and 16 depend from claims 1 or 9. Wetmore fails to disclose or suggest the features of claims 1 and 9 missing from the combination of Finken, Howard, and Foster, and as a result, the combination Finken, Howard, Foster, and Wetmore fails to render claims 8 and 16 unpatentable.
In response to argument (1), the Examiner does not find the Applicant’s argument(s) persuasive. The Examiner maintains the Applicant’s newly amended claimed limitations, as drafted, given the broadest reasonable interpretation, but for the recitation of generic computer components encompass managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions), which is a subgrouping of Certain Methods of Organizing Human Activity. This judicial exception is not integrated into a practical application because the remaining elements amount to no more than general purpose computer components programmed to perform the abstract idea, and generally linking the abstract idea to a technical environment. The Examiner maintains that the limitation of “generate a plurality of virtual barriers between participants and other trial personnel to block exchange of information regarding the type of intervention delivered” could be accomplished by a person following instructions to generate a plurality of virtual barriers between participants and other trial personnel. The “virtual barriers” recites in the Specification as “This problem is often encountered in several of the clinical trial situations. However, the intervention system as disclosed by the present invention creates a plurality of "chinese walls" between the participant and anyone else in the trial. A Chinese wall can be considered a virtual barrier erected to block the exchange of information between participants and anyone else in the trial.” (See Specification in p. 22-23), the Examiner maintains that under broadest reasonable interpretation “virtual barriers” are similar to firewalls, which a person following instructions, with the use of generic computer components, could create. The Examiner maintains that the “apply at least one randomization algorithm”, “operate the stimulation arrangement to”, “” are additional elements, and that the step of “divide a group of subjects into sub-groups and blocks, generating randomization files for applying various types of interventions to the sub-groups within the blocks, wherein the randomization files comprise a set of files including associated information between the bibliographic information and types of interventions generated using the at least one randomization algorithm”, “apply at least one intervention from the at least two different types of interventions to the one or more subjects, in accordance with the randomization files generated by the data processing arrangement, wherein the type of intervention delivered in accordance with relevant instructions is decided on automatically in accordance with the randomization files” could be accomplished by a person following instructions. The Examiner maintains that the claim is directed to organizing human activity and can be practically performed by a person following instructions. The addition of “hybrid electrodes” is an additional element that generally links the abstract idea to a technical environment discussed further below in response to argument (2). The 35 U.S.C. 101 rejection(s) stand.
In response to argument (2), the Examiner does not find the Applicant’s argument(s) persuasive. The Examiner maintains the Applicant’s newly amended claims are not integrated into a practical application because the remaining elements amount to no more than general purpose computer components programmed to perform the abstract idea, and generally linking the abstract idea to a technical environment. The Examiner maintains that the “apply at least one randomization algorithms”, “wherein the system is configured to”, “wherein the stimulation arrangement comprises a headwear arrangement including a plurality of hybrid electrodes, wherein the plurality of hybrid electrodes are configured to detect electrical signals generated by the brain of the at least one subject and provide electrical stimulation to the neurons in the brain of the at least one subject” are recited at a high degree of generality, amount no more than generally linking the abstract idea to a particular technical environment. The recitation is also similar to adding the words “apply it” to the abstract idea. As set forth in MPEP 2106.05(f), merely reciting the words “apply it” or an equivalent, is an example of when an abstract idea has not been integrated into a practical application. The claimed invention would require human involvement, for example, a person would have to place headwear arrangement including the hybrid electrodes on the subject or the subject would have to place headwear arrangement including the hybrid electrodes on themselves without proper training, the subject could then create a false result as the headwear arrangement may not be properly positioned. The Examiner maintains that the integration of hybrid electrodes with automated randomization and virtual barriers does not represent an unconventional combination. The Examiner maintains that the newly amended claims are similar to “iii. Gathering and analyzing information using conventional techniques and displaying the result, TLI Communications, 823 F.3d at 612-13, 118 USPQ2d at 1747-48” (See MPEP 2106.05(a)(II)) which the courts have indicated may not be sufficient to show an improvement to technology. The 35 U.S.C. 101 rejection(s) stand.
In response to argument (3), the Examiner does not find the Applicant’s argument(s) persuasive. The Examiner maintains that the claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of using a computer configured to perform above identified functions amounts to no more than mere instructions to apply the exception using generic computer components. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. See Alice 573 U.S. at 223 ("mere recitation of a generic computer cannot transform a patent-ineligible abstract idea into a patent-eligible invention.") Additionally, generally linking the abstract idea to a particular technological environment does not amount to significantly more than the abstract idea (See MPEP 2016.05(h) and Affinity Labs of Texas v. DirectTV, LLC, 838 F.3d 1253, 120 USP12d 1201 (Fed. Cir. 2016)). The Examiner maintains that the step of “wherein the system is configured to generate a plurality of virtual barriers between participants and other trial personnel to block exchange of information regarding the type of intervention delivered” only requires that the system is configured to generate a plurality of virtual barriers, but it is not described how or when the system would generate the plurality of virtual barriers. The system would also need to be programmed to identify when to generate a plurality of virtual barriers and how to identify who are participants or who are other trial personnel. The Examiner maintains that the newly amended claims are similar to “iii. Gathering and analyzing information using conventional techniques and displaying the result, TLI Communications, 823 F.3d at 612-13, 118 USPQ2d at 1747-48” (See MPEP 2106.05(a)(II)) which the courts have indicated may not be sufficient to show an improvement to technology. The Examiner maintains that the claimed invention would require human intermediaries for the purposes of setting up the protocols of the clinical trial, physical aid, and software programming. The Examiner does not acknowledge that the newly amended claimed invention improves medical device technology and networked device security or is similar to Enfish, LLC v. Microsoft Corp., 822 F.3d 1327 (Fed. Cir. 2016) as the Applicant’s claimed invention recites only that the system is configured to “generate a plurality of virtual barriers between participants and other trial personnel to block exchange of information regarding the type of intervention delivered”, not that the when or how the system accomplishes this “generate” step and the medical device technology is improved if the technology performs as intended, and does not return false results due to subject error. The Applicant’s Specification describes the “hybrid electrodes” in page 12 as “The plurality of electrodes may optionally be configured as any suitable EEG electrode arrangement known in the art. The plurality of electrodes are hybrid electrodes which can function as both for EEG recording and/or for electrical stimulation, for example, transcranial current stimulation (tCS), transcranial direct current stimulation (tDCS), transcranial alternating current stimulation (tACS), transcranial random noise stimulation (tRNS), transcranial temporal interference stimulation (TI), transcranial temporal summation (TS) and/or any other arbitrary transcranial electric current stimulation protocol generated by the adaptive algorithms (tES).” The hybrid electrodes are known in the prior art as Howard (US 2019/0381314) describes “In embodiments, data from in vitro and in vivo may be analyzed using intracellular and extracellular recordings to measure plasticity on a cellular/neuronal level and develop anatomical and functional mapping by using cellular imaging data as well as electrode electrophysiological data.” (Paragraph [0081]) and “at least one electrode or contact adapted to apply the nerve stimulation signal to a nerve of a human through a skin of the human” (Paragraph [0007]), which identifies that an electrode is capable of both receiving data and applying a stimulus. The hybrid electrodes are recited at a high degree of generality, amount no more than generally linking the abstract idea to a particular technical environment. The “virtual barriers” given their broadest reasonable interpretation and in light of the Specification amount to a “firewall”. The Examiner does not acknowledge that the additional elements that are sufficient to amount to significantly more than the judicial exception. The Examiner maintains the claims 1-17 recite an abstract idea without significantly more. The 35 U.S.C. 101 rejection(s) stand.
In response to argument (4), the Examiner does not find the Applicant’s argument(s) persuasive. The Examiner maintains that the combination of Finken, Howard, and Foster teach “wherein the system is configured to generate a plurality of virtual barriers between participants and other trial personnel to block exchange of information regarding the type of intervention delivered” as Howard describes in Paragraphs [0047], [0197], [0216]: Wireless communication unit may perform functions such as the access protocol, security/firewall, connect to app, data transfer, receive control from app, connect to TENS unit, which the Examiner is interpreting security/firewall to encompass generate a plurality of virtual barriers between participants and other trial personnel to block exchange of information regarding the type of intervention delivered as a firewall is a network security system that monitors and controls incoming and outgoing network traffic based on configurable security rules. In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, Howard describes a “firewall” in Paragraphs [0047], [0197], [0216]. The 35 U.S.C. 103 rejection(s) stand.
In response to argument (5), the Examiner maintains that the combinations of Finken, Howard, Foster, and Sillay, and Finken, Howard, Foster, and Wetmore teach the claims 4, 5, 12, and 13 and claims 8 and 16 respectively. The 35 U.S.C. 103 rejection(s) stand.
Conclusion
Simpson et al. (U.S. Patent Pre-Grant Publication No. 2013/0144644), describes a method of managing a clinical trial where the clinical trial involves a follow-on biological (FOB) substance.
Jain et al. (U.S. Patent Publication No. 11,281,553), describes methods, systems, and apparatus, including computer programs encoded on computer storage media, for improving distributed monitoring using different groups of remote devices.
Pavlovic et al. (“Web-Based Electronic Data Collection System to Support Electrochemotherapy Clinical Trial”), describes a web-based application for electronic data collection, which controls the users, interface to the system, is the core of the system.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Bennett S Erickson whose telephone number is (571)270-3690. The examiner can normally be reached Monday - Friday: 9:00am - 5:00pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Morgan can be reached at (571) 272-6773. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Bennett Stephen Erickson/Primary Examiner, Art Unit 3683