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.
Response to Amendment
In the amendment filed on July 23, 2026, the following has occurred: claim(s) 1-17 have been canceled and claim(s) 18-32 have been added. Now, claim(s) 18-32 are pending.
Claim Objections
Claim 18 objected to because of the following informalities: “the type of intervention” in p. 2, ll. 25. This appears to be a typographical error. Appropriate correction is required. For examination purposes, the Examiner will interpret the claimed portion as “a type of intervention”.
Claim 19 objected to because of the following informalities: “The intervention system of claim 1,” in p. 3, ll. 8. This appears to be a typographical error as claim 1 has been canceled. Appropriate correction is required. For examination purposes, the Examiner will interpret the claimed portion as “The intervention system of claim 18,”.
Claim 20 objected to because of the following informalities: “The intervention system of claim 1,” in p. 3, ll. 12. This appears to be a typographical error as claim 1 has been canceled. Appropriate correction is required. For examination purposes, the Examiner will interpret the claimed portion as “The intervention system of claim 18,”.
Claim 21 objected to because of the following informalities: “The intervention system of claim 1,” in p. 3, ll. 14. This appears to be a typographical error as claim 1 has been canceled. Appropriate correction is required. For examination purposes, the Examiner will interpret the claimed portion as “The intervention system of claim 18,”.
Claim 22 objected to because of the following informalities: “The intervention system of claim 1,” in p. 3, ll. 17. This appears to be a typographical error as claim 1 has been canceled, and claim 22 references elements that are present in claim 21. Appropriate correction is required. For examination purposes, the Examiner will interpret the claimed portion as “The intervention system of claim 21,”.
Claim 23 objected to because of the following informalities: “The intervention system of claim 1,” in p. 3, ll. 20. This appears to be a typographical error as claim 1 has been canceled. Appropriate correction is required. For examination purposes, the Examiner will interpret the claimed portion as “The intervention system of claim 18,”.
Claim 24 objected to because of the following informalities: “The intervention system of claim 1,” in p. 3, ll. 23. This appears to be a typographical error as claim 1 has been canceled. Appropriate correction is required. For examination purposes, the Examiner will interpret the claimed portion as “The intervention system of claim 18,”.
Claim 25 objected to because of the following informalities: “the collected bibliographic and physiological information” in p. 4, ll. 8, and “the type of intervention” in p. 4, ll. 19. These appear to be typographical errors. Appropriate correction is required. For examination purposes, the Examiner will interpret the claimed portion as “a collected bibliographic and physiological information” and “a type of intervention”.
Claim 28 objected to because of the following informalities: “the first intervention” in p. 5, ll. 5. This appears to be a typographical error. Appropriate correction is required. For examination purposes, the Examiner will interpret the claimed portion as “a first intervention”.
Claim 29 objected to because of the following informalities: “The method of claim 25,” in p. 5, ll. 6. This appears to be a typographical error as claim 29 references elements that are present in claim 25. Appropriate correction is required. For examination purposes, the Examiner will interpret the claimed portion as “The method of claim 25,”.
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”, “the memory module is configured to”, “the memory module” in claim 18, and “a memory module”, “the memory module is configured to”, “the memory module”, “the memory module” in claim 25.
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) 18-32 is/are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claims 18-24: Step 2A Prong One
Claim 18 recite(s):
(i) an input device, a memory module, a stimulation arrangement and a data processing arrangement that are communicably coupled via a communication arrangement, wherein the input device is configured to receive bibliographic and physiological information from the at least one subject via a user interface, and wherein the memory module is configured to store the received bibliographic and physiological information;
(ii) the stimulation arrangement is configured as a headwear arrangement;
(iii) an arrangement for providing at least two different types of interventions to the at least one subject in response to intervention instructions received from the data processing arrangement;
(iv) the data processing arrangement comprises processing hardware configured to execute computer-readable instructions to:
(a) apply at least one randomization algorithm to divide a group of subjects into sub-groups and blocks, and generate randomization files for applying various types of interventions to the sub-groups within the blocks, wherein the randomization files are stored in the memory module;
(b) operate the stimulation arrangement for the group of subjects in accordance with the randomization files, wherein the type of intervention delivered, by the stimulation arrangement, in accordance with relevant instructions is selected automatically in accordance with the randomization files and sent to the stimulation arrangement; and
(c) associate the received physiological information with the bibliographic information and the type of intervention in randomization files to generate associated information,
wherein the system is configured to implement blinded trials by automatically selecting, based on the randomization files, the type of intervention to be delivered to each subject and controlling the stimulation arrangement to deliver the selected types of intervention without disclosing the selected types of intervention to the subject
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 arrangement, wherein the input device is configured to receive bibliographic and physiological information from the at least one subject via a user interface, and wherein the memory module is configured to store the received bibliographic and physiological information”, (ii) the stimulation arrangement is configured as a headwear arrangement;”, “(iii) an arrangement for providing at least two different types of interventions to the at least one subject in response to intervention instructions received from the data processing arrangement;”, “(iv) the data processing arrangement comprises processing hardware configured to execute computer-readable instructions to:”, “(a) apply at least one randomization algorithm to”, “wherein the randomization files are stored in the memory module” 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 19 recites “a monitoring device”, claim 23 recites “a sensing arrangement”. For example, the claims encompass a person following instructions to divide a group of subjects into sub-groups and blocks, and determine randomization files for applying various types of interventions to the sub-groups within the blocks, a person following instructions to operate the stimulation arrangement for the group of subjects based on relevant instructions, a person following instructions to associate the received physiological information with the bibliographic information and the type of intervention, and a person following instructions to implement blinded trials.
Claims 19-25 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 19 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 20-22 include the abstract idea identified above and further describe the generic computer components. Similarly, claim 23 includes the abstract idea identified above and further describes a person controlling a generic computer component. Finally, claim 24 includes the abstract idea identified above and describes the intervention. Such steps encompass Certain Methods of Organizing Human Activity.
Claims 18-24: 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 18-24, directly or indirectly, recite the following generic computer components claim 18 recites “an input device, a memory module, a stimulation arrangement, and a data processing arrangement are communicably coupled via a communication arrangement, wherein the input device is configured to receive bibliographic and physiological information from the at least one subject via a user interface, and wherein the memory module is configured to store the received bibliographic and physiological information”, (ii) the stimulation arrangement is configured as a headwear arrangement;”, “(iii) an arrangement for providing at least two different types of interventions to the at least one subject in response to intervention instructions received from the data processing arrangement;”, “(iv) the data processing arrangement comprises processing hardware configured to execute computer-readable instructions to:”, “wherein the randomization files are stored in the memory module”, claim 19 recites “a monitoring device”, claim 23 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 “(a) apply at least one randomization algorithm to”, “wherein the system is configured to implement blinded trials by automatically selecting,”, 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 18-24: 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)). The claims are not patent eligible.
Claims 25-31 and 32 recite the same functions as claims 18-24, but in method and computer programme 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 25 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. The claim is not patent eligible.
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 18-20, 23, 25-27, 30, 32 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 18, Finken discloses an intervention system that, when in operation, automatically performs unbiased testing of at least one subject under investigative or experimental study, wherein the system comprises:
(i) 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 that are communicably coupled via a communication arrangement, wherein the input device is configured to receive bibliographic and physiological information from the at least one subject via a user interface (See Paragraphs [0009], [0020]-[0021], [0025]-[0027], [0065], [0070]: 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]), and the user interface for accessing the data collection engine to encompass via a user interface as user access may be controlled at the user interface based on usernames and passwords ([0070]: a patient or participant may have limited access to initiate scheduled or unscheduled communication), and wherein the memory module is configured to store the received 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 input device, and the memory module, Finken may not explicitly teach (ii) the stimulation arrangement is configured as a headwear arrangement;
(iii) an arrangement for providing at least two different types of interventions to the at least one subject in response to intervention instructions received from the data processing arrangement;
(iv) the data processing arrangement comprises processing hardware configured to execute computer-readable instructions to:
(b) operate the stimulation arrangement for the group of subjects in accordance with the randomization files, wherein the type of intervention delivered, by the stimulation arrangement, in accordance with relevant instructions is selected automatically in accordance with the randomization files and sent to the stimulation arrangement; and
wherein the system is configured to implement blinded trials by automatically selecting, based on the randomization files, the type of intervention to be delivered to each subject and controlling the stimulation arrangement to deliver the selected types of intervention without disclosing the selected types of intervention to the subject.
Howard teaches a system for (ii) the stimulation arrangement is configured as 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.);
(iii) an arrangement for providing at least two different types of interventions to the at least one subject in response to intervention instructions received from the data processing arrangement (See Paragraphs [0044]-[0047], [0055]: 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, and interpreting the stimulation unit sends out electrical impulses to encompass in response to intervention instructions received from the data processing arrangement as the Applicant’s Specification in p. 13-14 describe “Throughout the present disclosure, the term "data processing arrangement" as used herein relates to programmable and/or non- programmable components that, when in operation, execute one or more software applications for storing, processing and/or sharing of data and/or a set of instructions.” and “The stimulation arrangement stimulates the user on receiving the stimulation interventions from the data processing arrangement via the input device.” In p. 19-20 which the Examiner is interpreting the broadest reasonable interpretation of “intervention instructions” is data that is sent to initiate an action);
(iv) the data processing arrangement comprises processing hardware configured to execute computer-readable instructions (See Fig. 2 and Paragraphs [0046]-[0047]: The system 200 may include power supply 202, wireless communication unit 204, TENS unit 205, central control unit (processor) 206, storage control unit and storage 208, digital to analog converter (DAC) 210, analog to digital converter (ADC)/amplifier 212, digital signal processor (DSP) 214, output devices 216, and multimodal sensor array 218, which the Examiner is interpreting central control unit (processor) to encompass the data processing arrangement comprises processing hardware configured to execute computer-readable instructions) to:
(b) operate the stimulation arrangement for the group of subjects in accordance with the randomization files (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, by the stimulation arrangement, in accordance with relevant instructions is selected automatically in accordance with the randomization files and sent to the stimulation arrangement (See Paragraphs [0043], [0054]-[0055], [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), and interpreting a protocol of secure communication to encompass sent to the stimulation arrangement ([0054]-[0055])); and
wherein the system is configured to implement blinded trials (See Paragraphs [0196]-[0197]: Stimulation will be administered in a double-blind fashion) by automatically selecting, based on the randomization files, the type of intervention to be delivered to each subject and controlling the stimulation arrangement to deliver the selected types of intervention without disclosing the selected types of intervention to the subject (See [0091]-[0092], [0197]: Closed-loop neurostimulation based on available neuronal recording and meaningful behavioral performance can use measurements to automatically adjust the peripheral neurostimulation as the device is operating, which the Examiner is interpreting the automatic adjustment to encompass automatically selecting, based on the randomization files, the type of intervention to be delivered to each subject and controlling the stimulation arrangement to deliver the selected types of intervention without disclosing the selected types of intervention to the subject as the stimulation can be administered in a double-blind fashion.)
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 (ii) the stimulation arrangement is configured as a headwear arrangement; (iii) an arrangement for providing at least two different types of interventions to the at least one subject in response to intervention instructions received from the data processing arrangement; (iv) the data processing arrangement comprises processing hardware configured to execute computer-readable instructions to: (b) operate the stimulation arrangement for the group of subjects in accordance with the randomization files, wherein the type of intervention delivered, by the stimulation arrangement, in accordance with relevant instructions is selected automatically in accordance with the randomization files and sent to the stimulation arrangement; and wherein the system is configured to implement blinded trials by automatically selecting, based on the randomization files, the type of intervention to be delivered to each subject and controlling the stimulation arrangement to deliver the selected types of intervention without disclosing the selected types of intervention to the subject 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]).
While Finken/Howard teaches (iv) the data processing arrangement comprises processing hardware configured to execute computer-readable instructions as described above, Finken/Howard may not explicitly teach (iv) the data processing arrangement comprises processing hardware configured to execute computer-readable instructions to:
(a) apply at least one randomization algorithm to divide a group of subjects into sub-groups and blocks, and generate randomization files for applying various types of interventions to the sub-groups within the blocks, wherein the randomization files are stored in the memory module;
(c) associate the received physiological information with the bibliographic information and the type of intervention in randomization files to generate associated information.
Foster teaches a system for (iv) the data processing arrangement comprises processing hardware configured to execute computer-readable instructions (See Paragraphs [0012]-[0013]: The instructions are executable by the processor to cause the computing device to acquire clinical trial data from a remote database) 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), and generate 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 are stored in the memory module (See Paragraphs [0061], [0070], [0101]: Data structures are generally based on the ability of a computer to fetch and store data at any place in its memory, specified by an address, a bit string that can be itself stored in memory and manipulated by the program, which the Examiner is interpreting data structures to encompass the randomization files as a computer system configured to input, access, modify, and save information relating to a patient's health);
(c) associate the received physiological information with the bibliographic information and the type of intervention in randomization files to generate associated information (See Paragraphs [0061], [0070], [0116]: The machine learning technology can determine if a patient that is not currently eligible for a selected clinical trial may be eligible in the future or by the start date of the clinical trial based upon patient data including patient demographics, historical patient data, disease progression, treatment type, physician type, age, etc., which the Examiner is interpreting determining eligibility for a clinical trial to encompass associate the received physiological information with the bibliographic information and the type of intervention as the clinical trial encompasses the type of intervention, and the demographic information encompasses the bibliographic information.)
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 comprises processing hardware configured to execute computer-readable instructions to: (a) apply at least one randomization algorithm to divide a group of subjects into sub-groups and blocks, and generate randomization files for applying various types of interventions to the sub-groups within the blocks, wherein the randomization files are stored in the memory module; (c) associate the received physiological information with the bibliographic information and the type of intervention in randomization files to generate associated information 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) 25 and 32 mirror claim 18 only within different statutory categories, and are rejected for the same reasons as claim 18.
As per claim 19, Finken/Howard/Foster discloses the system of claim 18 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) 26 mirrors claim 19 only within a different statutory category, and is rejected for the same reasons as claim 19.
As per claim 20, Finken/Howard/Foster discloses the system of claim 18 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) 27 mirrors claim 20 only within a different statutory category, and is rejected for the same reasons as claim 20.
As per claim 23, Finken/Howard/Foster discloses the system of claim 18 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) 30 mirrors claim 23 only within a different statutory category, and is rejected for the same reasons as claim 23.
Claims 21-22, 28-29 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 21, Finken/Howard/Foster discloses the system of claim 18 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) 28 mirrors claim 21 only within a different statutory category, and is rejected for the same reasons as claim 21.
As per claim 22, Finken/Howard/Foster discloses the system of claims 18 and 21 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 analysed physiological information.
Sillay teaches a system wherein the data processing arrangement performs a second intervention to the at least one subject, based on the analysed 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) 29 mirrors claim 22 only within a different statutory category, and is rejected for the same reasons as claim 22.
Claims 24 and 31 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 24, Finken/Howard/Foster discloses the system of claim 18 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) 31 mirrors claim 24 only within a different statutory category, and is rejected for the same reasons as claim 24.
Response to Arguments
In the Remarks filed on July 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 Claim Interpretation(s), 35 U.S.C. 101 rejection(s), and 35 U.S.C. 103 rejection(s).
The Applicant argues that:
(1) the processor-executed storage, communication, device-control, and data-association operations cannot practically be performed in the human mind or using pen and paper. A person cannot electronically access stored randomization files, generate and transmit machine-readable intervention instructions between communicably coupled devices, or cause a connected stimulation arrangement to operate in response to those instructions. New claim 18 is therefore directed to operation of an interconnected intervention system, rather than merely to rules for organizing or supervising a trial;
(2) the specification identifies a technical deficiency in conventional intervention systems. Earlier systems could store predetermined codes for control and active interventions, but still required a clinician to receive the code and manually operate the intervention equipment. Because the equipment lacked direct communication with remote or cloud-based processing infrastructure, those systems could not fully automate the blinding process, implement adaptive trial operation, or be readily reconfigured without returning the equipment to the manufacturer (paragraph [0007]). A person of ordinary skill in the art would understand that the intervention instructions sent to the stimulation arrangement are electronic control data or signals, rather than verbal or written instructions provided to a human operator. The data processing arrangement is disclosed as including processing and networking hardware that executes instructions and shares data (paragraph [0067]). The input/output arrangement receives, converts, processes, and generates signals for operation of the stimulation hardware (paragraphs [0077] and [0107]). The processing hardware therefore does not merely create an allocation list for a clinician to follow. It retrieves or processes the electronically stored assignment, automatically selects the corresponding intervention, and sends intervention instructions to the stimulation arrangement. The stimulation arrangement receives the randomized intervention from the data processing arrangement (paragraph [0086]) and delivers the assigned intervention to the subject without requiring a third party to receive or enter the assignment (paragraph [0091]). The resulting technical data and control path is as follows: subject information is received by the input device; randomization files are generated and stored by the processing hardware; an intervention is selected from those files; intervention instructions are communicated to the stimulation arrangement; the intervention is physically delivered; and physiological information is returned and associated with the subject and intervention information. This end-to-end operation is expressly illustrated by the system data flow in Figure 1 and the corresponding description (paragraph [0106]). The nondisclosure of the selected intervention is likewise implemented through the technical operation of the system, rather than merely through a rule directed to trial personnel. The intervention assignment remains within the electronic processing and storage architecture, while the control information required to operate the stimulation arrangement is communicated to the stimulation hardware. The system may restrict access to the randomization data so that its functions are executed without disclosing the contents of the randomization files to the user or subject (paragraph [0080]). The assigned intervention is automatically delivered without third-party involvement (paragraph [0091]), and the data exchanged between the connected devices, including intervention-protocol information, may be protected using secure encryption (paragraph [0099]). A person of ordinary skill in the art would understand that this separation between intervention-assignment data and device-control instructions reduces the need to copy, display, or manually re-enter sensitive assignment information at the subject-facing device. That arrangement reduces the number of human and electronic transfer steps through which the assignment must pass, thereby reducing opportunities for erroneous entry, unintended disclosure, and repeated verification of manually entered codes. It also improves information security by limiting the number of devices and users to which the intervention identity must be exposed, consistent with the disclosed secured access and encrypted communication arrangements (paragraphs [0080] and [0099]). The central data processing arrangement further reduces repeated processing and communication steps associated with translating a randomized assignment into operation of the intervention equipment. The Specification explains that data and signals exchanged between the input device and stimulation arrangement pass through the data processing arrangement (paragraph [0073]). A person of ordinary skill in the art would understand that this centralised machine-to-machine pathway avoids a separate manual code-delivery and code-entry cycle and permits the assignment to be applied directly by the connected system. This reduces execution latency and the number of input, validation, and communication operations required to initiate the assigned intervention. The architecture also reduces reconfiguration cycles in adaptive trials. Conventional equipment could require physical return to the manufacturer to be repurposed during a trial (paragraph [0007]). In contrast, the disclosed system may generate a second set of randomization files using collected information and perform a second intervention in accordance with that second set (paragraph [0074]). A person of ordinary skill in the art would understand that electronically updating the randomization files and intervention instructions allows the system to alter subsequent intervention delivery without physical reprogramming or replacement of the stimulation equipment, thereby reducing device-handling, configuration, and processing iterations. The claim also requires the returned physiological information to be associated with the relevant subject and intervention data. The input device may receive physiological information from a connected measuring device (paragraph [0056]), and the data processing arrangement associates that information with the bibliographic information and randomization files (paragraphs [0072] and [0073]). The system therefore maintains a machine-readable link between the intervention selected by the randomization process and the physiological response obtained following delivery of that intervention. Considered as a whole, claim 18 recites an interconnected, cloud-capable intervention-control architecture in which processing hardware converts stored randomized assignments into control instructions for a physical stimulation arrangement and receives physiological response data through the same integrated system. The communication arrangement, processing hardware, memory module, and stimulation arrangement operate cooperatively to remove the manual intermediary previously required to translate a trial assignment into operation of the intervention equipment. Claim 18 therefore does more than generally place randomization in a technological environment. It recites how subject information is received, how the intervention assignments are generated and stored, how a selected intervention is converted into control instructions, how those instructions are transmitted to the stimulation arrangement, how the physical intervention is delivered, and how resulting physiological information is associated with the assignment. The randomization process is thus integrated into a practical application. Independent method claim 25 recites the corresponding operation of the communicably coupled components, and claim 32 recites a non-transitory computer-readable storage medium containing instructions for performing that operation. Claims 25 and 32 integrate the claimed randomization into a practical application for substantially the same reasons;
(3) even if the Office maintains that claims 18-32 are directed to an abstract idea under Step 2A, the claimed ordered combination amounts to significantly more than the randomization and allocation concept. The ordered combination requires processing hardware to generate randomized intervention assignments (paragraphs [0070]-[0073]), store those assignments in the memory module (paragraphs [0072] and [0106]), automatically select an intervention using the assignments (paragraphs [0073], [0086], and [0091]), communicate corresponding instructions to a connected stimulation arrangement (paragraphs [0069], [0086], and [0106]), operate the stimulation arrangement to deliver the selected intervention without disclosing its identity to the subject (paragraphs [0080] and [0091]), and associate received physiological information with the relevant subject and intervention data (paragraphs [0072], [0073], and [0106]). The Office Action relies on portions of the specification stating that the individual components may be implemented using available devices and technologies. For example, the input device may be a smartphone, tablet, computer, smartwatch, remote control, or medical device (paragraph [0058]); the memory module may be implemented using volatile or persistent electronic storage (paragraph [0060]); the data processing arrangement may be implemented using a computer, local server, server arrangement, or cloud server (paragraph [0067]); and the communication arrangement may use Internet, Bluetooth, cellular, or Wi-Fi connections (paragraphs [0057] and [0069]). These implementation alternatives do not establish that the claimed interaction of the components was conventional. Rather, they show that the disclosed improvement is not dependent upon a particular hardware brand, database format, cloud provider, or communication protocol. The technical contribution lies in the architecture and data flow by which electronic randomization is directly linked to physical intervention delivery and physiological-response processing. The specification expressly distinguishes that architecture from conventional systems. Earlier equipment lacked direct communication with cloud-based processing infrastructure, required a clinician to receive and apply an intervention code, could not truly automate blinding or adaptive operation, and could require return to the manufacturer for reconfiguration (paragraph [0007]). The present system instead uses the data processing arrangement as the central element through which the relevant data and signals pass (paragraph [0073]) and automatically delivers the assigned intervention without a third-party intermediary (paragraph [0091]). A person of ordinary skill in the art would understand that the claimed ordered combination provides technical effects beyond the individual operation of a processor, memory, or communication interface. Direct electronic conversion of a randomized assignment into intervention-control instructions reduces manual input and verification cycles, reduces communication latency between assignment and delivery, and reduces the number of processing and user-interface operations required to execute the intervention. Centralized storage and restricted communication of the assignment reduce unnecessary replication and exposure of sensitive data, improving system security. Electronic generation of subsequent randomization files also permits adaptive operation without repeated physical reconfiguration of the intervention equipment. The Office Action has not established that this ordered combination and these cooperative functions were well-understood, routine, and conventional in the relevant intervention-system field. The fact that individual processors, memories, servers, and communication interfaces were known does not establish that it was conventional to use them in the claimed arrangement to maintain randomized assignments, automatically generate device-control instructions, operate connected intervention hardware without disclosing the assignment, and associate returned physiological data with the delivered intervention. At least for these reasons, claim 18 is patent eligible. Independent claims 25 and 32 are patent eligible for the same reasons. Dependent claims 19-24 are patent eligible at least because of their dependencies. In addition, dependent claims 19-24 further recite secured electronic access, multiple assigned interventions, analysis of physiological information, performance of a subsequent intervention based on that analysis, sensing of parameters required for correct execution, and specified physical stimulation modalities. Dependent claims 26-31 are also patent eligible at least because of their dependencies. In addition, claims 26-31 recite the same additional technical operations as claims 19-24. These limitations further connect the processing arrangement to secure access control, physiological sensing, adaptive operation, and physical intervention delivery. Accordingly, claims 18-32 integrate the claimed randomization and allocation process into a practical application and, alternatively, recite an ordered combination amounting to significantly more than that process. Applicant respectfully requests withdrawal of the rejection under 35 U.S.C. § 101;
(4) claim 18 requires processing hardware to apply a randomization algorithm to divide subjects into subgroups and blocks and generate randomization files assigning intervention types within those blocks (paragraphs [0070]-[0072]). Finken does not disclose such randomized block assignment. Foster's filtering of patient records to identify potentially eligible subjects is not randomization, and an eligible subset is not a subgroup or block within which intervention types are randomly assigned. The generated randomization files must also be stored in the memory module and used by the processing hardware to automatically select the intervention to be delivered (paragraphs [0072], [0073], and [0106]). Finken does not disclose subject-specific intervention assignments generated by a randomization algorithm. Nor do Howard's stimulation protocols or Foster's patient-treatment information constitute randomization files used to determine which intervention is delivered to a particular subject. The selected intervention is then sent to the stimulation arrangement, which is operated in accordance with that selection (paragraphs [0069], [0073], [0086], and [0091]). Finken does not disclose processing hardware that converts a randomized intervention assignment into instructions for a connected stimulation arrangement. Howard's stimulation protocols describe how stimulation may be administered, but do not disclose automatic selection of an intervention for a particular subject from stored randomization files. The selected intervention must also be delivered without disclosing its identity to the subject. The specification explains that the system executes the randomized intervention without disclosing the contents of the randomization files (paragraph [0080]) and automatically delivers the assigned intervention without requiring a third party to receive or communicate the assignment (paragraph [0091]). Howard's statement that a study may be double-blind, and its general reference to a firewall, do not disclose this technical mechanism. In particular, the cited passages do not show that randomized intervention assignments are withheld while corresponding control instructions are transmitted to the stimulation arrangement. The system further associates the received physiological information with the bibliographic information and the delivered intervention in the randomization files (paragraphs [0072], [0073], and [0106]). Finken does not disclose linking physiological response data to an electronically assigned and automatically delivered intervention within the same randomization-file architecture. Accordingly, even if Finken, Howard, and Foster were combined, the resulting system would not provide the claimed sequence in which processing hardware generates randomized subject-intervention assignments, stores those assignments, automatically selects and communicates the assigned intervention to a connected stimulation arrangement, controls delivery without disclosure to the subject, and associates the resulting physiological information with that assignment;
(5) the stated motivations do not remedy these deficiencies. A desire to improve cognitive performance may provide a reason to use stimulation equipment, and a desire to improve data management may provide a reason to organize patient information. Neither explains why a person of ordinary skill in the art would modify the cited systems to create the claimed automated randomization, blinding, and intervention-control pathway. The rejection therefore relies on Applicant's disclosure as a roadmap rather than on a teaching or reason arising from the cited references. Applicant respectfully submits that claim 18 is not rendered obvious by Finken, Howard, and Foster. Claims 19-24 depend from claim 18 and are patentable for at least the same reasons. The cited references also do not cure the missing architecture by disclosing the additional limitations relating to secured access, randomized assignment of multiple interventions, intervention adaptation based on analysed physiological information, or sensing parameters required for correct execution. Wetmore's disclosure of additional stimulation modalities does not supply the missing randomization, blinding, and automatic intervention-control pathway. Corresponding method claims 25-31 and computer-readable-medium claim 32 are patentable for the same reasons. Accordingly, Applicant respectfully requests withdrawal of the rejections under 35 U.S.C. § 103.
Applicant's arguments filed July 23, 2026 have been fully considered but they are not persuasive.
In response to argument (1), the Examiner does not find the Applicant’s argument(s) persuasive. The Examiner maintains that the 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. The Applicant argues that the abstract idea cannot be practically be performed in the human mind or using pen and paper, the Examiner maintains that the Applicant’s newly added claims are directed to a CMOHA, not a Mental Process. The Examiner maintains that the additional elements are recited at a high level of generality that 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 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 that the Applicant’s claims are not sufficient to show an improvement to technology as the Applicant’s 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”, which the courts have indicated is not sufficient to show an improvement to technology (See MPEP 2106.05(a)(II)). The additional elements of “an input device”, “a memory module”, “stimulation arrangement”, “a data processing arrangement”, “a communication arrangement” are recited at a high level of generality that amounts to “merely include[ing] instructions to implement an abstract idea on a computer”. The Examiner maintains that the Applicant’s newly added claims recite an abstract idea without significantly more as 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, and that the additional elements included allow for mere automation of manual processes, such as using a generic computer (See MPEP 2106.05(a)(II)). 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. 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.") The Examiner maintains that the Applicant’s additional elements operate similarly to a processor, memory, and communication interface within a generic computer, and one of ordinary skill in the art would understand that the claimed order of combination is using a generic computer as a tool. The Examiner maintains that the Applicant’s claimed limitations of “an input device, a memory module, a stimulation arrangement, and a data processing arrangement are communicably coupled via a communication arrangement” recite computer functions as well‐understood, routine, and conventional functions as the claims recite “i. Receiving or transmitting data over a network, e.g., using the Internet to gather data, Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information); TLI Communications LLC v. AV Auto. LLC, 823 F.3d 607, 610, 118 USPQ2d 1744, 1745 (Fed. Cir. 2016) (using a telephone for image transmission);”, and “iv. Storing and retrieving information in memory, Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93” (See MPEP 2106.05(d)(II)). The Examiner maintains the 35 U.S.C. 101 rejection(s). 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 teaching of Foster teaches “apply a randomization algorithm to divide subjects into subgroups and blocks and generate randomization files assigning intervention types within those blocks” as the broadest reasonable interpretation of the “randomization algorithm to divide subjects into subgroups and blocks” is sorting patients into separate groups and blocks based on a random pattern, which the Examiner is interpreting that the teachings of Foster ([0073]-[0074], [0081], [0088]) when combined with Howard’s teachings of “Stimulation will be administered in a double-blind fashion. Half of the participants will receive tVNS and the other half will receive sham stimulation. For details on the sham procedure please refer to 3.2” in Paragraph [0185] to describe the randomized pattern. The Examiner maintains that Howard does teach “wherein the type of intervention delivered, by the stimulation arrangement, in accordance with relevant instructions is selected automatically in accordance with the randomization files and sent to the stimulation arrangement” in Paragraphs [0043], [0054]-[0055], [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), and interpreting a protocol of secure communication to encompass sent to the stimulation arrangement ([0054]-[0055])). The Examiner maintains that the combination of Finken/Howard/Foster teaches “processing hardware that converts a randomized intervention assignment into instructions for a connected stimulation arrangement” as Howard teaches in 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, and in Paragraph [0092]: “Closed-loop neurostimulation based on available neuronal recording and meaningful behavioral performance can use measurements to automatically adjust the peripheral neurostimulation as the device is operating. In this way, the closed-loop control could guide perturbations of neural systems (neurons and circuits) to achieve sophisticated, near real-time control over neurostimulation/neuromodulation and cognitive skill training.” The Examiner maintains Howard’s teachings in Paragraphs [0196]-[0197] of “Stimulation will be administered in a double-blind fashion” and the “automatic adjustment” in Paragraphs [0091]-[0092], [0197] teaches the Applicant’s claimed limitation of “wherein the system is configured to implement blinded trials…without disclosing the selected types of intervention to the subject”. The Examiner maintains Foster teaches “associates the received physiological information with the bibliographic information and the delivered intervention in the randomization files” in Paragraphs [0061], [0070], [0116] as described above in the 35 U.S.C. 103 rejection(s). The Examiner maintains that Finken, Howard, and Foster teach the newly amended independent claims 18, 25, and 32. The 35 U.S.C. 103 rejection(s) stand.
In response to argument (5), the Examiner does not find the Applicant’s argument(s) persuasive. In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). The Examiner maintains that the combination of Finken, Howard, Foster teaches the newly added claims 18-20, 23, 25-27, 30, 32 combination of Finken, Howard, Foster, and Wetmore teaches the newly added claims 21-22 and 28-29, combination of Finken, Howard, Foster, and Wetmore teaches the newly added claims 24 and 31 as described above in the 35 U.S.C. 103 rejection(s). The 35 U.S.C. 103 rejection(s) stand.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
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.
THIS ACTION IS MADE FINAL. 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 Bennett S Erickson whose telephone number is (571)270-3690. The examiner can normally be reached Monday - Friday: 9:00am - 5:00pm.
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/Bennett Stephen Erickson/Primary Examiner, Art Unit 3683
