DETAILED ACTION
This office action is based on the claim set filed on 07/17/2026.
Claims 1, 10, and 15 have been amended.
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 .
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 “a digital twin of a biological asset of a subject wherein the digital twin comprises a computational simulation of a physical counterpart and dynamically updated with data pertaining to a state of the physical counterpart to provide an up-to-date digital representation,...”, 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 [0014] discloses “Proposed embodiments may thus provide automatic and dynamic DT recommendation and/or adaption concepts that cater for different users”, and [0024], disclose “Dynamic and/or automated control/adaptation concepts may therefore be realized by proposed embodiments”, [0038] “Such concepts may enable adaptation of a DT to a user and may also be extended to automatic and / or dynamic adaptation” which describes a dynamic adaption which is actively altering its behavior or the physical system based on changing conditions and that is different than dynamic updating that focuses on real-time data synchronization to reflect the current physical state. There is not explicit disclosure as filed describing the step of dynamically updated with data pertaining to a state of the physical counterpart 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 comprises a computational simulation of a physical counterpart and dynamically updated with data pertaining to a state of the physical counterpart to provide an up-to-date digital representation, and wherein the digital twin continually receives and integrates data from the physical counterpart into the computational simulation, and 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, and wherein the control unit is further configured to generate a control instruction based on the generated one or more parameter values for controlling at least one element or component of the digital twin, the at least one element or component comprising at least one of: input requirements of the digital twin; program code of the digital twin; a model of the digital twin; output characteristics of the digital twin; and tunable elements of the digital twin;
wherein the control system is configured to display one or more of the plurality of outputs of the digital twin, wherein displaying comprises 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. Moreover, the additional element of using “control unit” to perform “generate a control instruction …” is using the parameters value to perform the generation of instruction by the control unit 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(g),(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 07/17/2026 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 the 35 U.S.C. § 112(a) rejection on page 8-12.
In response to the claim amendment(s) and Applicant argument, Examiner withdraws the 112(a) rejection.
Applicant's arguments with respect to the 35 U.S.C. § 101 rejection on page 12-20.
On page 13-14 of the remarks, Applicant argues “The present amendments materially change the eligibility analysis because the independent claims comprise significantly more than collecting information, generating values, and displaying selected information ... The Office Action characterizes the claims... That characterization does not reflect the amended claims as a whole ... Thus, the amended claims do not use "digital twin" as a generic computer label. They recite a particular computational modeling architecture that is dynamically updated from a physical counterpart and that generates simulation outputs based on model inputs and computational model characteristics ... Thus, the amended claims are not directed merely to the type of human observation, evaluation, judgment, or opinion identified in the Office Action. There is no mental equivalent of a digital twin”, Examiner respectfully disagree. The amended claim(s) as recited, under BRI, describes a process of computational simulation to mimic human using a user information to generate digital twin (DT)/computational simulation parameters 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).
While the Applicant argues that the amended claim describes a dynamic updating of the computational simulation and generating control instruction for controlling technical elements or components of the digital twin itself, Examiner finds that the claim(s), as amended, describes feature that is recited generically and at high level of generality and does not show how this dynamic update of the computational simulation is implemented, “i.e., via bidirectional feedback loops, rather the specification [0014] “Proposed embodiments may thus provide automatic and dynamic DT recommendation and/or adaption concepts that cater for different users”, and similarly in [0024], [0038], and [0048] describing a dynamic adaption concept to different users which is interpreted as generic data collection and processing while such adaptation is a mere collection user data, updating a virtual model, and running simulations are viewed by court and patent office as basic data manipulation and generic computational steps and does not describe any improvement to how the computer or simulation functions.
Moreover, the argued feature for generating instruction for controlling technical elements based on the parameters values is a mere recitation of obtaining parameters (user, subject status, historical usage) for controlling the digital twin elements described at a high level and does not describe how the instruction nor the parameters are generated to control the elements. For example, specification [0024], [0038] describes “The invention provides concepts for generating one or more parameter values for a DT according to a user... aspects of a DT can be controlled (e.g. adapted, modified or otherwise changed) according to its user (s)”, [0045] describes “The interface 110 is configured to provide the obtained information/data to the control unit 150 for processing according to proposed embodiments. The control unit 150 is configured to generate one or more parameter values for the DT 105 based on the obtained user information ... is configured to implement a machine-learning algorithm for generating one or more parameter values...”, [0046], [0047] “Parameter values that may be generated for the DT 105 may include ... the control unit 150 may determine values and / or types to be used by one or more elements of the DT..., [0048] “the control unit 150 may be further configured to generate a control instruction for a CDSS or a DT based on the generated one or more parameter values...”, however nowhere in the specification describes how the controlling unit is configured to generate instruction based on parameters values rather is evaluated as an additional element to where the generating instruction is based on generated values which is treated as an additional feature added to the exception that amounts to no more than adding the words "apply it" (or an equivalent) with the judicial exception.
Furthermore, on page 15 of the remarks, Applicant argues “A person can write down a desired confidence threshold, but that is not the same as generating a control instruction that controls input requirements, program code, ... A person can manually compare values, but that is not the same as controlling the computational simulation that generates digital twin outputs” Examiner respectfully disagree. Examiner asserts that an individual may be able to manually perform functions, such as creating program code and instruction as inputs to manipulate output while the claimed invention describes generic computing components used as tool receiving one or more input to generate one or more output. Moreover, while the Applicant argues that “the amended claims require a technical feedback path from generated parameter values to the operation of a computational simulation. The parameter values are used to control how the digital twin is configured or operated, including what inputs it requires ...” Examiner finds that performance of computational simulation requires an input values based on a user information that is feed to the control unit in order to generate parameters for the DT and display. For Example, the specification [0020] describes “The user may be a provider of input data to the digital twin , such as a person (e.g. nurse or technician) collecting, selecting, controlling or monitoring data for the DT...”, [0040] “adapt DT according to user characteristics”, and [0048] “output information in the form of advice or feedback (e.g. instructions for data collection or instruction to adapt procedures) to a user (e.g. physician)...” which describe an abstract steps for defining output based on information and displaying outputs which is a mere data display that is not enough to transform the abstract idea into a patent-eligible invention.
On page 17 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... Thus, the claimed parameter generation is not an end in itself. The generated values are applied to configure or control the digital twin's operational architecture.”, Examiner respectfully disagree. As described above, the claim as a mended recites additional elements that amounts to no more than adding the words "apply it" (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer “e.g., generate a control instruction based on the generated on or ore parameters values ...”. 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. Mere instructions to apply an exception using generic computer components “i.e., applying a machine-learning algorithm” to the abstract idea cannot provide an inventive concept. Thus, the claims as a whole are therefore directed to an abstract idea and are patent ineligible.
On page 18 of the remarks, Applicant argues “The amended claims therefore are materially different from a claim that merely implements an abstract idea on a generic computer or merely links information analysis to a technological environment ... This is a practical application under MPEP § 2106.04(d)(l) and§ 2106.05(a), because the claims apply the generated parameter values to improve or adapt the operation of a technological system, namely a digital twin simulation”, Examiner respectfully disagree. The amended claims and specification, there are no improvements to another technology or technical field, no improvements to the functioning of the computer itself, transformation or reduction of a particular article to a different state or thing or any other meaningful limitations beyond generally linking the use of an abstract idea to a particular technological environment as a result of performing the claimed method. The claimed sequence of steps comprises only "conventional steps, specified at a high level of generality," which is insufficient to supply an "inventive concept." Id. at 2357 (quoting Mayo, 132 S. Ct. at 1294, 1297, 1300). The addition of merely novel or non-routine components to the claimed idea does not necessarily turn an abstraction into something concrete (See Ultramercial, Inc. v. Hulu, LLC, _ F.3d_, 2014 WL 5904902, (Fed. Cir. Nov. 14, 2014). Hence, the claims do not recite significantly more than an abstract idea.
On page 20 of the remarks, Applicant argues “For similar reasons, the amended claims also recite significantly more than any alleged abstract idea... Thus, even if the Office were to maintain that the claims include an abstract idea, the amended claims contain additional limitations that amount to significantly more than that alleged idea.”, Examiner respectfully disagree. As described above, the fact that a generic computing system, such as described above, can be suitably programmed to perform the claimed method without requiring any nonconventional computer, network, or other computing components, or even a "non-conventional and non-generic arrangement of known, conventional pieces" but instead merely call for performance of the claimed functions on a set of generic computer components, the elements of the instant process, when taken alone, each execute in a manner conventionally expected of these elements. The elements of the instant process, when taken in combination, together do not offer substantially more than the sum of the functions of the elements when each is taken alone. Hence, these additional elements do not add anything significantly more than an abstract idea.
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
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a). A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee 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 date of this final action.
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/ALAAELDIN M. ELSHAER/Primary Examiner, Art Unit 3687
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