DETAILED ACTION
This office action is based on the claim set filed on 03/30/2026.
Claims 1, 10, 13, and 15 have been amended.
Claims 2-3, 11, 16-18 have been canceled.
Claims 19-23 are new.
Claims 1, 4-10, 12-15, and 19-23 are currently pending and have been examined.
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 .
Notice to Applicant
In accordance with the February 5, 2026 Decision on Appeal, the PTAB reversed the
rejections of claims 1, 3-10, and 12-18 under 35 U.S.C. § 103 and therefore the§ 103 rejections of the claims are hereby withdrawn.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim(s) 1, 4-10, 12-15, and 19-23 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
In order to satisfy the written description requirement, the specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See MPEP 2161.01(1). However, generic claim language in the original disclosure does not satisfy the written description requirement if it fails to support the scope of the genus claimed, and even original claims may fail to satisfy the written description requirement when the invention is claimed and described in functional language but the specification does not sufficiently identify how the invention achieves the claimed function, See MPEP 2161.01(1) citing in part Ariad, 598 F.3d at 1349 ("[A]n adequate written description of a claimed genus requires more than a generic statement of an invention's boundaries.").
Specifically, with regard to computer-implemented functional claims, the specification must provide a disclosure of the computer and the algorithm in sufficient detail to demonstrate to one of ordinary skill in the art that the inventor possessed the invention, including how to program the disclosed computer to perform the claimed function. MPEP 2161.01(1).
Claim 1, 10, and 15 recite “wherein displaying comprises automatically enabling or disabling display of each of the plurality of outputs of the digital twin ...”, for which the subject matter of the limitation was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, at the time the application was filed, had possession of the claimed invention. As best understood, it appears that there is no support for the underlined recitation in the original disclosure of the present application for this limitation. As described in applicant’s specification [0048] discloses “the control signal may comprise control instructions for a display and/or medical equipment, thus enabling the medical equipment to be automatically and/or pre-emptively controlled”, and [0053], disclose “After the user selects at least one of the options, necessary data collection or calculations can start (enabling the DT output generation)”. There is not explicit disclosure as filed describing the step of automatically enabling or disabling display of outputs as claimed.
The examiner takes the position that with respect to these limitations or features of the claims, the specification fails to provide an adequate written description of the invention to an extent that would sufficiently show that applicant was in possession of an invention that could operate as claimed. Simply disclosing a vague description, without actually explaining how to perform the function(s) claimed, results in a written description problem under 112(a). The examiner has no idea how applicant actually contemplated doing these steps because nothing is disclosed other than the broad disclosure of the specification as mentioned above.
Therefore, applicant has failed to show the actual subject matter in their possession at the time of the invention in a way sufficient to reasonably convey to one skilled in the relevant art that applicant had possession of the claimed invention at the time the application was filed. Therefore, these limitations of the claims are considered to be new matter. Appropriate correction is required.
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 1, 4-10, 12-15, and 19-23 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Claims 1 and 4-9 are drawn to a system, Claims 10 and 12-14 are drawn to a method, and Claims 15 and 19-23 is drawn to an art of manufacturer/computer product, which is within the four statutory categories (i.e., a machine and a process). Claims 1, 3-10, 12-18 are further directed to an abstract idea on the grounds set out in detail below.
Under Step 2A, Prong 1, the steps of the claim for the invention represents an abstract idea of a series of steps that recite a process for modelling human subjects providing a personalized output. This abstract idea could have been performed mentally but for the fact that the claims recite a general-purpose computer processor to implement the abstract idea for steps citing a process directed to collecting plurality of information, analyzing and determine values for biological function for which both the instant claims and the abstract idea are defined as Mental Process.
Independent Claim 1 recites the steps, similarly claims 9, 10, 15, disclose the steps of:
“a digital twin of a biological asset of a subject wherein the digital twin is configured
to generate a plurality of digital twin outputs
an interface adapted to obtain: (i) user information describing one or more characteristics of a user of the digital twin, wherein the user information comprises a user profile for the user; (ii) subject status information describing a medical status of the subject; and (ii) historical usage data describing previous usage of the digital twin;
a display; and
a control unit configured to generate one or more parameter values for the digital twin based on the obtained user information, the obtained subject status information, and the obtained historical usage data, wherein the control unit comprises a data analysis component configured to implement a machine-learning algorithm for generating the one or more parameter values, and further wherein the machine-learning algorithm is trained using training inputs and known outputs, the training inputs comprising user information, subject status information, and historical usage data obtained for each of a plurality of subjects, and wherein the known outputs comprise one or more parameter values for a digital twin, and wherein the one or more parameter values comprise at least a confidence value and a decision threshold value
wherein the control system is configured to display one or more of the plurality of outputs of the digital twin, wherein displaying comprises automatically enabling or disabling display of each of the plurality of outputs of the digital twin based on a comparison of: (i) a user profile-specific minimum confidence measure; and (ii) the confidence value and the decision threshold value.”
These limitations, as drafted, given the broadest reasonable interpretation, cover performance of the limitations in the mind that constitute Mental Processes but for the recitation of generic computer components. This abstract idea could have been performed by a human mind with the aid of pencil and paper but for the fact that the claims recite a general-purpose computer processor to implement the abstract idea for steps citing a process directed to collecting plurality of information, analyzing and determine values for biological function of a subject with confidence and threshold values, and provide an output, which are steps that could be performed mentally with the aid of pencil and paper that are similar to the steps of observing, evaluating, judgment and opinion which are citing a process for which can be performed using a human mind with the aid of pencil and paper, see MPEP § 2106.04(a)(2)(III). Accordingly, the claim limitations (in BOLD) recite an abstract idea. Any limitations not identified above as part of the process are deemed "additional elements," and will be discussed in further detail below.
Under Step 2A, Prong 2, this judicial exception is not integrated into a practical application because the remaining elements amount to no more than a component programmed to perform the abstract ideas and linking the abstract idea to a particular technological environment. In particular, the claims recite the additional elements such as “interface, controller unit/system, control unit, processor, digital twin, non-transitory computer-readable medium, machine-learning, database, data analysis component, display” that is/are disclosed at a high - level of generality implementing generic computer functions, e.g., “display[ing]”, and is described in the specification in an arbitrary form without disclosing any description how that implements the identified abstract idea. For example, the machine learning algorithm is recited in the claim(s) at a high level and is directed to an already developed/trained model(s) without disclosing process for training the model or teach an algorithm how to make predictions using the dataset for allowing the model to learn patterns and relationships within the data and implement it. This recitation of additional element(s), is merely implemented as a tool such that it amounts no more than adding the words "apply it" (or an equivalent) with the judicial exception to perform the abstract idea that merely uses the computer as a tool to perform the abstract idea, see MPEP 2106.05(f), generally linking the use of the judicial exception to a particular technological environment or field of use, see MPEP 2106.05(h), and a mere data gathering process that does not add a meaningful limitation to the above abstract idea, see MPEP 2106.05(d). 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. Accordingly, looking at the claim as a whole, individually and in combination, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
Under step 2B, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because they do not present improvements to another technology or technical field and the additional elements amount to no more than a generic computer components, recited at a high level of generality, that amounts to no more than adding the words "apply it" (or an equivalent) to apply the exception using generic computer component, that merely uses the computer as a tool to perform the abstract idea, see MPEP 2106.05(f), generally linking the use of the judicial exception to a particular technological environment or field of use, see MPEP 2106.05(h), and a mere data gathering process that does not add a meaningful limitation to the above abstract idea, see MPEP 2106.05(a),(d). Their collective functions merely provide conventional computer implementation and mere instructions to apply an exception using a generic computer component to the abstract idea 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"). Therefore, whether considered alone or in combination, the additional elements do not amount to significantly more than the abstract idea
Dependent Claims 4-8, 12-14, and 19-23 include all of the limitations of claim(s) 1, 9, 10, and 15, and therefore likewise incorporate the above-described abstract idea. While the depending claims add additional limitations, such as
As for claims 3, 5, 7-8, 12, 14, 20, and 22-23 the claim(s) recite limitations that are under the broadest reasonable interpretation, further define the abstract idea noted in the independent claim(s) that covers performance by a human mind with the aid of pen and paper but for, the recitation of the generic computer components which are similarly rejected because, neither of the claims, further, defined the abstract idea and do not further limit the claim to a practical application or provide an inventive concept such that the claims are subject matter eligible. The claims recite additional elements “processor, controller unit, analysis component, machine learning algorithm, digital twin, display” that implement the identified abstract idea. These hardware components are recited at a high level of generality (i.e., general purpose computers/components implementing generic computer functions), for example, machine learning algorithm and neural network recited in the claim(s) at a high level and is directed to an already developed/trained model(s) without disclosing process for training the model. These elements effectively amount to no more than the words "apply it" with a computer because it appears to intend to do so, which would still amount to 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 ("significantly more").
As for claims 4, 6, 13, 19, 21, the claim(s) recite limitations that are under the broadest reasonable interpretation, further define the abstract idea noted in the independent claim(s) that covers performance by a human mind with the aid of pen and paper but for, the recitation of the generic computer components which are similarly rejected because, neither of the claims, further, defined the abstract idea and do not further limit the claim to a practical application or provide an inventive concept such that the claims are subject matter eligible. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept ("significantly more").
Response to Amendment
Applicant's arguments filed 03/30/2026 have been fully considered by the Examiner and addressed as the following:
In the remarks, Applicant argues in substance that:
Applicant's arguments with respect to claim objection on page 7.
In response to the claims amendments/cancelation, Examiner withdraws claims 17-18 objection.
Applicant's arguments with respect to the 35 U.S.C. § 112 rejection on page 8.
In response to the claims amendments/cancelation, Examiner withdraws 112(a) rejections for claims 17-18.
Applicant's arguments with respect to the 35 U.S.C. § 101 rejection on page 8-12.
On page 9 of the remarks, Applicant argues “Applicant respectfully submits that amended independent claims 1, 10, and 16 are not directed merely to collecting information, analyzing it, and producing a result... Rather, they impose a specific control regime on operation of the digital twin itself by constraining which outputs the digital twin may generate and/or present under particular confidence conditions tied to the user profile. That amendment tracks the technical solution expressly disclosed in the Specification. The Specification explains that the invention addresses technical problems...”, Examiner respectfully disagree. Examiner respectfully asserts that the claims are given their broadest reasonable interpretation for the purpose of determining whether they encompass a judicial exception. While the claim(s) as recited, under BRI, describes a process for obtaining user information to generate digital twin (DT) parameters based on the user information and provide representation output to be manipulated by the user, which recite a mental process and/or organizing human activity interaction with a computing system while the claim(s) contain limitations that can practically be performed in the human mind with the aid of pencil and paper, but for the fact that the claims recite a general-purpose computer components “processor, memory, display, machine learning algorithm” to implement the abstract idea, including for example, observations, evaluations, judgments, and opinions, see MPEP § 2106.04(a)(2)(III) and Electric Power Group v. Alstom., S.A., 830 F.3d 1350, 1353-54, 119 USPQ2d 1739, 1741-42 (Fed. Cir. 2016).
Furthermore, with regards to the argument that the claims impose a specific control on operation, Examiner finds that claim(s), and as amended, do/does not recite how the operation is perform in order to impose a specific control but a mere recitation of obtaining information (user, subject status, historical usage) of a digital twin and how using such information to generate parameter values of the digital twin while implementing a machine-learning algorithm and how the machine-learning algorithm. Such process is described at a high level of generality to generate parameter values and provide outputs but no specific way or process for controlling the operation. In addition, nowhere in the specification describes any measure for the accuracy of the DT and how the accuracy is impacted with the parameter values for the DT other than describing at a high-level implementation of parameter values for improving the DT, (see at least Applicant [0017], [0039], [0049]).
On page 10 of the remarks, Applicant argues “the Specification expressly discloses that the generated parameter values may include "a confidence value" and "a decision threshold value" and that such parameter values determine how DT outputs should be generated and what functionalities or outputs are prioritized or allowed for the DT user (Specification, paragraphs [0023] and [0047], ... paragraph [0055] disclose employing a minimum confidence threshold to restrict output generation options ... paragraph [0069] discloses user-specific confidence thresholds for displaying outputs; and FIG. 6 with paragraphs [0071]-[0073] discloses displaying only those additional outputs that satisfy user profile- specific criteria)”, Examiner respectfully disagree. First, the Applicant specification [0023] and [0047] describes at a high level using the generated parameters values that include "a confidence value" and "a decision threshold value" to determine how DT outputs should be generated such that using these values to determine the output for a specific user while there is no description how are these values implemented to improve interface of the DT. Moreover, the Applicant argument of restricting output based on confidence threshold, [0055] however such a process is describing access of the user based on the user information or criteria which is an abstract step for defining output based on information. Furthermore, the argues section [0069], [0071]-[0073] describes user criteria for outputs and displaying outputs which is a mere data display that is not enough to transform the abstract idea into a patent-eligible invention. See Alice, 573 U.S. at 225-26; see also Inventor Holdings, LLC v. Bed Bath & Beyond, Inc., and Univ. of Fla. Rsch. Found., Inc. v. Gen. Elec. Co. and Inte-rval Licensing LLC v. AOL, Inc.,
On page 10-11 of the remarks, Applicant argues “Even assuming, arguendo, that the claims are directed to an abstract idea, the elements of the claims, individually and in combination, integrate the exception into a practical application ... They recite a specific mechanism by which the digital twin is adaptively controlled ... This is the disclosed technological solution for improving DT operation under uncertainty and differing user capabilities ... The Office Action states that the claims merely link the abstract idea to a technological environment and that the machine-learning recitation is only a high-level tool. That characterization no longer fits the amended claims...”, Examiner respectfully disagree. As described above, the claim, under BRI, describes obtaining information and using the information to generate parameters for DT and output the presentation according to the obtained information, which are steps identified as abstract while the claims nor the specification do not provide any technological or technical improvement or attributes an improvement in computer technology or functionality to the claimed invention or that otherwise indicates that the claimed invention uses the judicial exception in a manner that imposes a meaningful limit on the judicial exception.
The fact that the judicial exception, identified in the rejection above, relies upon gathering data and analyzing user information to generate parameters and determine output of a user does not impart an improvement to any existing computer, or any other technology or technical field. At best, this gathering of data to be used by the general machine-learning algorithm may improve the abstract idea of determining DT parameters and outputs. However, improving upon an abstract idea does not make the abstract idea any less abstract. Furthermore, the machine-learning analytics model is not configured in a manner other than what any off-the-shelf, commercially available processor is capable of being programmed to do. Even when considering the claims additional elements (e.g., processor, machine-learning algorithm), the claims as a whole, individually and in combination, provide no integration of the abstract ideas into a practical application that no meaningful limits on practicing the abstract idea are introduced, see MPEP 2106. The claims as a whole are therefore directed to an abstract idea.
On page 11-12 of the remarks, Applicant argues “In Example 47, ... Claim 3 was eligible when the ANN output was used to perform specific technical remedial actions that improved network security. In Example 48, ... Claim 2 was eligible when additional steps used those results to synthesize and generate a new speech signal, thereby improving speech-separation technology. The amended claims here are analogous to the eligible claims in those examples ... the machine-learning output is not the endpoint. Rather, the generated parameter values are used to automatically control the digital twin's output generation/display in a confidence-constrained, user-specific manner, thereby improving digital-twin-based clinical decision support”, Examiner respectfully disagree. In Example 47, the claim doesn’t recite mental process because the human mind is not equipped to detect a source address associated with malicious network packets, drop the malicious network packets in real time, and block future traffic as recited in the claim. These limitations were found to integrate the claim into practical application because the claim as a whole includes an improvement to a computer or to a technological field. The evaluation of these limitations describes a system that detects a source address of network intrusions and takes a real-time action by dropping suspicious packets and block traffic from the detected source address which are directed to taking proactive measures to remediate the danger in real time by detecting the source address associated with the potentially malicious packets as such the claim as a whole integrates the judicial exception into a practical application. In contrast, the claim of the invention recites a process of determining a user information and determining parameters values for DT based on the user information and associate the user information to provide a display of the DT to the data based on type of viewer. In addition, the automation step is described as mere automation of manual processes, such as using a generic computer to process the steps that may be an automated or a manual process (see Applicant [0010], [0038], [0048]) which is different than what Example 47 is performing. Therefore, the claimed invention is not similar to Example 47.
In Example 48 claim 1 was found ineligible because it recites a judicial exception, however claims 2 and 3 were found eligible because the claims as a whole integrates the exception into a practical application. Improving speech to text transcription. Similarly, as discussed above, Applicant argues that the claimed invention use automatic control to generate display in confidence-constrained, user-specific manner that improve digital-twin-based clinical decision support, Examiner finds that the improvement of Example 48 is addressing a technical issue and technical filed while improving clinical decision support and provide more efficient medical care is/are not an improvement addressing a technical field or a system rather addressing administrative problem. Therefore, the claimed invention is not similar to Example 48.
On page 12 of the remarks, Applicant argues “A human may conceptually assess confidence, but the amended claims require a digital twin control system that automatically enables or disables generation and/or display of outputs of the digital twin based on generated confidence and threshold values and a user-profile-specific minimum confidence measure. That is an operational control of a digital twin system, not merely a mental observation or opinion”, Examiner respectfully disagree. While the specification does not describes how the system automatically enables or disables generation of output data, see specification [0048] discloses “the control signal may comprise control instructions for a display and/or medical equipment, thus enabling the medical equipment to be automatically and/or pre-emptively controlled”, and [0053], disclose “After the user selects at least one of the options, necessary data collection or calculations can start (enabling the DT output generation)”, mere automation of manual processes, such as using a generic computer to process the output may not be sufficient to show an improvement in computer-functionality or technical field, see MPEP 2106.05(a)(I).
Therefore, the Applicant argument is found to be unpersuasive and Examiner remains the 101 rejections of claims which have been updated to address Applicant's argument.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALAAELDIN ELSHAER whose telephone number is (571)272-8284. The examiner can normally be reached M-Th 8:30-5:30.
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/ALAAELDIN M. ELSHAER/Primary Examiner, Art Unit 3687
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