Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 September 12, 2025 has been entered.
Response to Amendment
The following Office action in response to communications received September 12, 2025. Claims 1 and 18 have been amended. Therefore, claims 1-20 are pending and addressed below.
Applicant’s amendments to the claims are not sufficient to overcome the rejections set forth in the previous office action dated April 11, 2025.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Based upon consideration of all of the relevant factors with respect to the claims as a whole, the claims are directed to non-statutory subject matter which do not include additional elements that are sufficient to amount to significantly more than the judicial exception because of the following analysis:
Independent Claim(s) 1, 14 and 18 are directed to a system for clinical trial data modeling and simulation. The claim(s) recite(s) “obtaining, a corpus of historical clinical trial data associated with each of a plurality of candidate clinical trials; deriving, a statistical model for each of the plurality of candidate clinical trials based on the corpus of historical clinical trial data associated with each of the plurality of candidate clinical trials; receiving, a selection of at least a subset of a plurality of statistical models derived for the plurality of candidate clinical trials: in response to receiving input of the selection of at least the subset, computing, a composite statistical model comprising based on calculating a weighted average of a combination of the subset the statistical model for each of the plurality of candidate clinical trials; generating, a synthetic statistical model for a target clinical trial based on adapting the composite statistical model using a plurality of distinct variable values extracted from data associated with a configuration of the target clinical trial; receiving, a value setting for one or more of the plurality of distinct variable values; receiving, an indication of the intervention designation or the comparator designation for each one of the plurality of candidate trials; in response to receiving input of the value setting for each of the plurality of distinct variable values, initializing, a plurality of simulation parameters comprising a representation of the synthetic statistical model and a set of input values for a the plurality of distinct variables associated with the synthetic statistical model; executing, a plurality of virtual simulations with the plurality of simulation parameters; generating, clinical trial intelligence data based on the execution of the plurality of virtual simulations.”
The limitations of “obtaining, a corpus of historical clinical trial data associated with each of a plurality of candidate clinical trials; deriving, a statistical model for each of the plurality of candidate clinical trials based on the corpus of historical clinical trial data associated with each of the plurality of candidate clinical trials; receiving, a selection of at least a subset of a plurality of statistical models derived for the plurality of candidate clinical trials: in response to receiving input of the selection of at least the subset, computing, a composite statistical model comprising based on calculating a weighted average of a combination of the subset the statistical model for each of the plurality of candidate clinical trials; generating, a synthetic statistical model for a target clinical trial based on adapting the composite statistical model using a plurality of distinct variable values extracted from data associated with a configuration of the target clinical trial; receiving, a value setting for one or more of the plurality of distinct variable values; receiving, an indication of the intervention designation or the comparator designation for each one of the plurality of candidate trials; in response to receiving input of the value setting for each of the plurality of distinct variable values, initializing, a plurality of simulation parameters comprising a representation of the synthetic statistical model and a set of input values for a the plurality of distinct variables associated with the synthetic statistical model; executing, a plurality of virtual simulations with the plurality of simulation parameters; generating, clinical trial intelligence data based on the execution of the plurality of virtual simulations,” as drafted, under its broadest reasonable interpretation, covers the performance of a Mental Process concepts performed in the human mind (including an observation, evaluation, judgment, opinion, wherein the derivation of statistical models, the computation of a composite model, and the comparison of clinical data are activities that could theoretically be performed in the human mind or with the aid of pen and paper), but for the recitation of generic computer components. That is, other than reciting “memory, non-transitory computer-readable medium, computer, computer processors, virtual simulation computing system, interactive simulation GUI,” nothing in the claim element precludes the step from practically being performed in the mind. For example, but for the “computer” language, “obtaining” in the context of this claim encompasses the user manually retrieving via a network a corpus of historical clinical trial data associated with each of a plurality of candidate clinical trials. Similarly, the generating, clinical trial intelligence data based on the execution of the plurality of virtual simulations, wherein the clinical trial intelligence data includes one or more graphical simulation artifacts, covers performance of the limitation in the mind, but for the recitation of generic computer components. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind, but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
This judicial exception is not integrated into a practical application. In particular, the claims recite the additional elements of using a “memory, non-transitory computer-readable medium, computer, computer processors, virtual simulation computing system, interactive simulation GUI” to perform all of the obtaining, deriving, computing, generating, initializing, executing and providing steps. The “memory, non-transitory computer-readable medium, computer, computer processors, virtual simulation computing system, interactive simulation GUI” is/are recited at a high-level of generality (i.e., as a generic processor performing a generic computer function of executing computer-executable instructions for implementing the specified logical function(s) such that it amounts no more than mere instructions to apply the exception using a generic computer component. Accordingly, this additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
Claim 1 has the following additional elements (i.e., computer, computer processors, virtual simulation computing system, interactive simulation GUI). Claim 14 has the following additional elements (i.e., non-transitory machine-readable storage medium, computer, computer processors, virtual simulation computing system, interactive simulation GUI). Claim 18 has the following additional elements (i.e., memory, non-transitory computer-readable medium, computer, computer processors, virtual simulation computing system, interactive simulation GUI). Looking to the specification, these components are described at a high level of generality (¶ 44-47; The computer processor(s) 130 may function to retrieve, process, and manage data or instructions from other modules of the clinical trial intelligence system 101. The computer processor(s) 130 may include a single processing unit, or, alternatively, may encompass multiple processing units that function in parallel or independently. In embodiments where multiple processors are utilized, these processors may reside on the same physical host system or may be distributed across multiple host systems, potentially located in geographically disparate locations). The use of a general-purpose computer, taken alone, does not impose any meaningful limitation on the computer implementation of the abstract idea, so it does not amount to significantly more than the abstract idea. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements individually. The combination of elements does not indicate a significant improvement to the functioning of a computer or any other technology and their collective functions merely provide a conventional computer implementation of the abstract idea. Furthermore, the additional elements or combination of elements in the claims, other than the abstract idea per se, amount to no more than a recitation of generally linking the abstract idea to a particular technological environment or field of use, as the courts have found in Parker v. Flook. Therefore, there are no limitations in the claims that transform the judicial exception into a patent eligible application such that the claims amount to significantly more than the judicial exception.
Dependent claims 2-13, 15-17 and 19-20 include all the limitations of the parent claims and are directed to the same abstract idea as discussed above and incorporated herein. Although the dependent claims add additional limitations, they only serve to further limit the abstract idea by reciting limitations on what the information is and how it is received and used. These information characteristics do not change the fundamental analogy to the abstract idea grouping of “Mental Process,” and, when viewed individually or as a whole, they do not add anything substantial beyond the abstract idea. Furthermore, the combination of elements does not indicate a significant improvement to the functioning of a computer or any other technology. Therefore, the claims when taken as a whole are ineligible for the same reasons as the independent claims.
Response to Arguments
Applicant’s arguments filed September 12, 2025 have been fully considered but they are not persuasive. In the remarks applicant argues:
(1) I. CLAIM REJECTIONS UNDER 35 U.S.C. 101
The Office Action rejects the claims under 35 U.S.C. §101 because the claimed
invention is allegedly directed to an abstract idea without significantly more. Applicant
respectfully traverses the rejection.
While not conceding to the appropriateness of the above-identified rejection,
Applicant submits that the current claims, as amended, recite patent-eligible subject
matter under 35 U.S.C. §1o based on the 2019 Revised Patent Subject Matter Eligibility
Guidance (2019 PEG) and the 2024 Guidance Update on Patent Subject Matter
Eligibility (2024 PEG):
1. A computer-implemented method for implementing an interactive
simulation user interface (GUI) for controlling operations of a
clinical intelligence service, comprising:
at a clinical intelligence service implemented by a distributed
network of computers:
implementing the interactive simulation GUI comprising:
(i) a first display section presenting one or more graphical simulation
artifacts based on an execution of a plurality of virtual simulations:
(ii) at least a second display section having a plurality of user input elements,
wherein the plurality of user input elements comprising (a) a first set of user input elements that control a setting of simulation parameters and initialization of a virtual simulation computing system, (b) a second set of user input elements that control a creation of a composite model, and (c) a third set of user input elements that control an intervention designation or a comparator designation of a corpus of data associated with one of a
plurality of candidate trials; obtaining, via a computer network from one or more sources of
digital data, a corpus of historical clinical trial data associated with each of a plurality of candidate clinical trials; deriving, by one or more computer processors, a statistical model for each of the plurality of candidate clinical trials based on the corpus of historical clinical trial data associated with each of the plurality of candidate clinical trials; receiving, via user inputs to the second set of user input elements, a selection of at least a subset of a plurality of statistical models derived for the plurality of candidate clinical trials; in response to receiving input of the selection of at least the subset, computing, by the one or more computer processors, a composite statistical model comprising a combination of the subset; generating, by the one or more computer processors, a synthetic model for a target clinical trial based on adapting the composite statistical model using a plurality of distinct variable values extracted from data associated with a configuration of the target clinical trial; receiving, via user inputs to the first set of user input elements, a value setting for one or more of the plurality of distinct variable values; receiving, via user inputs to the third set of user input elements, an indication of the intervention designation or the comparator designation for each one of the plurality of candidate trials; in response to receiving input of the value setting for each of the plurality of distinct variable values, initializing, by the one or more computers executing a virtual simulation computing system with a plurality of simulation parameters comprising a representation of the synthetic statistical model and the plurality of distinct variables associated with the synthetic statistical model; executing, by the virtual simulation computing system, a plurality of virtual simulations based at least on the initialization of the virtual simulation computing system with the plurality of simulation parameters; generating, by the one or more computer processors, clinical trial intelligence data based on the execution of the plurality of virtual simulations, wherein the clinical trial intelligence data includes one or more graphical simulation artifacts; and providing to: at least the first display section of the interactive simulation graphical user interface (GUI), a real-time display of the one or more graphical simulation artifacts, and at least the second display section of the interactive simulation GUI, a set of editable user interface input elements that, when manipulated, configure or reconfigure one or more of the plurality of simulation parameters of the virtual simulation computing system causing a re- execution of a succeeding plurality of virtual simulations.
Claim 1 has been amended to clarify that the invention is not directed to an abstract idea, but to a specific, structured, and interactive graphical user interface (GUI) that enables a user to directly control and dynamically operate a clinical intelligence service, particularly for running virtual clinical trial simulations. The claim describes not only the graphical structure of the GUI- comprising first and second display sections-but also defines the GUI's functional interaction with a virtual simulation computing system in a way that improves both the usability and efficiency of clinical simulation systems. In particular, the user's manipulation of editable user input elements within the second display section causes immediate updates to simulation parameters, which automatically triggers the execution of updated virtual simulations and real-time rendering of graphical simulation artifacts within the first display section of the GUI.
Under Step One of the Alice/Mayo test, the claims are not directed to a judicial exception, but rather to a specific technological improvement in graphical user interface design, one that enables real-time control of computational simulation tasks without requiring manual re-initialization or external triggering. This GUI-driven system behavior closely aligns with USPTO Example 34, which explains that claims directed to a GUI that repositions obscured textual information are patent-eligible because they recite a specific interface layout and behavior that improves the way a computer system functions. Likewise, the claimed invention is not directed to the abstract idea of simply visualizing or processing clinical data. Instead, the invention improves how users interact with a computing system by providing an integrated GUI structure that supports continuous simulation reconfiguration, execution, and feedback without interrupting the user's workflow. The GUI is not a passive display tool, but the primary means by which the underlying simulation system is operated and updated.
Additionally, the present claims are analogous to the patent-eligible claims presented in USPTO Example 46, which involved a time-based messaging interface that improved message navigation by grouping communications in a way that enhanced user experience. The USPTO found those claims to be eligible because they provided a non-conventional, user-centered improvement to interface functionality. Similarly, amended Claim 1 recites a non-generic GUI layout that enables a user to configure simulation parameters, trigger re-execution, and view updated outputs all within a single interactive environment, thus improving usability and eliminating the technical inefficiencies associated with separate or manually synchronized simulation tools.
Even assuming arguendo that the claims were found to be directed to an abstract idea, under Step Two of the Alice framework, the claim recites significantly more by way of a specific combination of interactive GUI components and computational processes that operate together in a manner that is neither routine nor conventional. The claim's integration of editable user interface elements, a virtual simulation computing system, and real-time feedback of simulation outputs provides a unified and functionally integrated system that improves the speed, accuracy, and responsiveness of simulation execution. The system as claimed provides a technical solution to a problem rooted in computer-based clinical simulations-namely, the need to efficiently reconfigure and re-execute simulations on demand without restarting the system or manually refreshing datasets.
As in Trading Technologies International v. CQG, where a GUI was found to be patent-eligible due to its improvement to the trading experience, the present claim defines a GUI that provides a practical application of simulation control, directly linking user interface interaction to computing system behavior in a novel and useful way. Likewise, the claim meets the criteria outlined in Core Wireless Licensing v. LG Electronics, where GUI claims were found patent-eligible because they provided an efficient structure for navigating information and controlling computing operations. Taken together, these authorities and USPTO examples confirm that GUI-based inventions that enable improved interaction with data or control over system operations are not abstract, and when claimed with sufficient specificity-as is the case here-they are patent-eligible. The present claims go well beyond mere data display or mathematical modeling and instead define an interactive and operational control framework through which simulation parameters are received, processed, and re-applied by the system in real time.
Accordingly, Applicant respectfully submits that the claims, as amended, are directed to a practical application of interface and computing architecture, and recite a specific improvement in computing functionality, consistent with both Federal Circuit precedent and the USPTO's own eligibility guidance. Withdrawal of the rejection under 35 U.S.C. §101 is respectfully requested.
Interactive GUI that Controls Virtual Simulations
The Office Action appears to assert (without explanation) that the claimed interactive simulation GUI does not transform the judicial exception into a patent eligible application. However, as shown by way of example in FIG. 7 and throughout the specification of the present application (e.g., paras [oo6i] and [0062]), the interactive simulation GUI may be used to control and meaningfully manipulate the configuration and/or operation of a given virtual simulation. In fact, the interactive simulation GUI provide editable user elements that simplify and makes intuitive an operation of a complex virtual simulator without having to code or use a computer programming language to set the parameters of the virtual simulations.
[0061] In some examples, the set of editable UI input elements 158 may configure or reconfigure the one or more simulation parameters 147 by triggering the clinical trial intelligence service 101 to update at least one of the set of distinct variable values associated with the configuration of the target clinical trial. Upon updating at least one of the set of distinct variable values associated with the configuration, re-generating of the synthetic statistical model 142 may occur for re-execution of the succeeding set of virtual simulations. In order to facilitate the updating of at least one of the set of distinct variable values, the editable UI input elements 158 may be configured such that a user may select which distinct variable value should be updated. For instance, each of a subset of the editable UI input element 158 may correspond to a respective variable value that may be adjusted by a user. After performing the adjusting, the UI 160 may provide an indication of updated target clinical trial data 163 (e.g., updated distinct variable values) to clinical trial intelligence service 101 (e.g., to synthetic model generator 140). Synthetic model generator 140 may use the updated distinct variable values to generate an updated synthetic statistical model.
Accordingly, Applicant respectfully submits that the claimed invention does not merely recite an abstract idea of displaying or analyzing clinical trial data. Rather, the interactive simulation GUI provides a technical solution to a computing-related problem, namely the inefficiency and lack of real-time adaptability in computer- implemented clinical trial simulations. The interactive simulation GUI providing editable user elements, such as element 720, element 725, editable elements within 705, allows user to dynamically modify simulation parameters and view real-time changes in graphical simulation artifacts.
Applicant points the Office to Trading Technologies International, Inc. v. CQG, Inc. (2017) in which the Federal Circuit held that a GUI that improves usability and efficiency in a trading system was patent-eligible because it enhanced human- computer interaction in a specific way. Like the GUI in Trading Technologies, the claimed interactive simulation GUI does more than merely display information. The claimed interactive simulation GUI provides a real-time, interactive system for modifying and executing virtual simulations, which improves efficiency and accuracy in virtual clinical trial modeling.
Moreover, the claimed GUI-based simulation system is specifically designed to address challenges in computational clinical trials, a problem that does not exist outside the realm of computing. The real-time interaction enabled by the interactive simulation GUI allows users to reconfigure simulation models without restarting the system, significantly improving computational efficiency.
Accordingly, Applicant submits that at least the implementation of the interactive simulation GUI that dynamically configures and/or reconfigures the virtual simulation computing system transforms the alleged abstract idea to patent-eligible subject matter as required by 35 USC 101.
Accordingly, Applicant requests withdrawal of the 35 U.S.C. § 101 rejection.
In response to argument (1), Examiner has considered Applicant's arguments but maintains the rejection of claims 1 and 18 under 35 U.S.C. § 101. While Applicant has made clarifying amendments and presented persuasive analogies to USPTO examples and Federal Circuit precedent, the claimed invention remains directed to an abstract idea with only conventional computer implementation.
1. Step One Analysis: The Claims Are Directed to an Abstract Idea
Claims 1 and 18 are directed to the abstract idea of organizing, modeling, and simulating clinical trial data through a graphical user interface. The core of the claimed invention involves: (1) collecting historical clinical trial data, (2) deriving statistical models from that data, (3) creating composite and synthetic models through mathematical combination and adaptation, (4) receiving user inputs to adjust simulation parameters, (5) executing virtual simulations based on those parameters, and (6) displaying results. These are fundamentally mental processes and mathematical operations that could be performed by a human statistician or clinician using pencil, paper, and traditional analysis techniques.
Applicant argues that the claims are directed to a "specific technological improvement in graphical user interface design." However, the claimed GUI elements—first display section for presenting artifacts, second display section with input elements for setting parameters, creating composite models, and designating interventions—are generic, high-level descriptions of interface components. The claims do not specify how the GUI improves computer functionality beyond the abstract concept of providing a user-friendly interface for controlling simulations. As such, the focus remains on the abstract idea of modeling and simulating clinical trials, with the GUI merely serving as a conduit for user input and output.
While Applicant cites USPTO Example 34 (repositioning obscured textual information) and Example 46 (time-based messaging interface), the present claims lack the specific, unconventional interface improvements found in those examples. Here, the GUI structure is described at a functional level (sections and sets of input elements) without reciting a specific arrangement or behavior that solves a computing problem in a non-conventional way. The claimed GUI facilitates the abstract idea but does not itself represent a technological advancement in human-computer interaction.
2. Step Two Analysis: The Claims Do Not Recite an Inventive Concept
Even assuming arguendo that the claims are directed to an abstract idea, they fail to recite an "inventive concept" sufficient to transform that idea into a patent-eligible application. The additional elements, individually and in combination, amount to no more than conventional computer implementation.
The claim elements recite generic computer components and routine functions: a "distributed network of computers," "one or more computer processors," obtaining data "via a computer network," "deriving" statistical models, "computing" composite models, "generating" synthetic models, "receiving" user inputs, "executing" virtual simulations, and "providing" displays. These are all well-understood, routine, conventional activities in the field of computer-implemented simulation and data analysis. The specification acknowledges that the system uses "standard" or "conventional" computing hardware and software components to perform these functions.
Applicant's argument that the claims provide "a technical solution to a computing-related problem, namely the inefficiency and lack of real-time adaptability in computer-implemented clinical trial simulations" is not supported by the claim language. The claims recite what the system does (real-time display and reconfiguration) but not how it achieves technical efficiency improvements. The real-time interaction is achieved through conventional event-driven programming and data refresh techniques, not through a specific, unconventional technical implementation.
The references to Trading Technologies and Core Wireless are distinguishable. In Trading Technologies, the Federal Circuit found eligibility because the claims recited a "specific, structured graphical user interface" that solved a problem of speed and accuracy in electronic trading by providing a static price index and a dynamic display region—a specific technical improvement to how trading information was presented and manipulated. Here, the claims recite functional GUI sections without the specific, unconventional interface features that provided a technical solution in Trading Technologies. Similarly, Core Wireless involved a specific, unconventional way of organizing application views to improve navigation efficiency on small-screen devices. The present claims lack comparable specificity in GUI structure or behavior.
3. The "Weighted Average" Limitation Does Not Add Patentable Weight
The amendment adding "based on calculating a weighted average" to claims 1 and 18 merely further defines the mathematical nature of the abstract idea. Calculating weighted averages is a fundamental mathematical operation that falls squarely within the "mathematical concepts" judicial exception. Adding this detail does not transform the abstract idea into a patent-eligible application; it merely further describes the abstract idea itself.
Therefore, Claims 1 and 18 remain rejected under 35 U.S.C. § 101 because they are directed to the abstract idea of organizing, modeling, and simulating clinical trial data, and the additional elements recite only generic computer implementation of that abstract idea. While Applicant's arguments highlight the practical utility of the invention in the field of clinical trial simulation, utility alone does not confer patent eligibility under § 101. For the claims to be allowable, they would need to recite either: (1) a specific, unconventional technological improvement in computer functionality or GUI design (beyond merely facilitating the abstract idea), or (2) a specific, non-conventional technical implementation that solves a computing problem in a new way.er respectfully disagrees.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US-20210319158-A1 to Bhattacharyya; Jaydeep; A method, according to some implementations, includes generating a plurality of base datasets using a random number generator and determining scenario specifications. The method may further include identifying at least one transformation function for at least one of the pluralities of base datasets based on the scenario specifications and transforming the at least one of the pluralities of base datasets using the at least one transformation function. In some cases, the method may also include generating scenario parameters based on the at least one transformed dataset.
US-20210241865-A1 to Bhattacharyya; Jaydeep; A method, according to some implementations, includes providing inputs to a plurality of trial design simulation engines, receiving first outputs of the plurality of trial design simulation engines in response to the inputs, and providing variations of the inputs to the plurality of trial design simulation engines. The method may further include receiving second outputs of the plurality of trial design simulation engines in response to the variations evaluating the first and the second outputs to determine delta values, and determining, based in part on the delta values, a plurality of normalization factors for the plurality of trial design simulation engines.
US-20210240886-A1 to Bhattacharyya; Jaydeep; A method, according to some implementations, includes displaying an interface structured to evaluate design data by a group of users and identifying user parameters for each user in the group. The method may further includes configuring the interface for each user in the group based at least in part on the user parameters, receiving, via the interface, user input data from one or more users in the group, and scoring designs based on the user input and user parameters.
US-20210240883-A1 to Bhattacharyya; Jaydeep; A method, according to some implementations, includes obtaining a criterion for a trial design study, determining permutations for designs in response to the criteria, and determining permutations for scenarios in response to the criteria. The method may further include generating combinations of the permutations for the designs and the permutations for the scenarios, simulating designs corresponding to the generated combinations, and determining performance of the simulated designs.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EDWARD B WINSTON III whose telephone number is (571)270-7780. The examiner can normally be reached M-F 1030 to 1830.
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.
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/E.B.W/ Examiner, Art Unit 3683
/ROBERT W MORGAN/ Supervisory Patent Examiner, Art Unit 3683