METHOD AND SYSTEM FOR COMPUTATIONAL MODELING AND SIMULATION OF THE OPERATION AND/OR BEHAVIOR OF MEDICAL DEVICES WHICH ARE IMPLANTABLE OR USABLE ON PATIENTS

Application No. 17/042,759

• Filed: Sep 28, 2020
• Examiner: COTHRAN, BERNARD E
• Art Unit: 2188
• Tech Center: 2100 — Computer Architecture & Software
• Assignee: Insilicotrials Technologies S R L
• OA Round: 6 (Final)

Office Action

DETAILED ACTION
1. This office action is in responsive to the applicant’s arguments filed on 7/21/25.
2. The present application is being examined under the first inventor to file provisions of the AIA .
3. Claims 25-31, 33-34, 36, 38-42 and 45-47 are currently pending.
4. Claims 25 and 42 are amended. Claims 26-31, 33-34, 36, 38-41 and 45-47 are previously presented.
5. Claims 32, 35, 37 and 43 are cancelled.

Response to Arguments
Response: 35 U.S.C. § 101
6. Applicants argue:
The applicant argues that claim 25 recite limitations that integrate the abstract ideas into a
practical application and inventive concept, where the claim is directed towards eligible subject
matter. Also, the applicant argues that even if the method performed with respect to "a
medical device which is implantable or usable on a patient,", qualifies as a judicial exception, it
is implemented and/or used in conjunction with "a particular machine or manufacture" - the
medical device. The applicant also argues that the previous office action has not addressed that
claim 25 recites a method in which a particular machine or manufacture is integral to the claim,
where it states “a medical device which is implantable or usable on a patient”. (Remarks: pages
13-14)

7. Examiner Response:
The examiner respectfully disagrees. The examiner notes that even with the recent
amendment to claim 25, the claims are still not eligible under 35 U.S.C. 101. The examiner
also notes that the limitation of claim 25 shown above, that states “wherein the medical device
is implantable and/or usable on patients” is not stating that the medical device is being
implanted. The recent amendment is stating that the medical device can be implantable and/or
usable on a patient. The limitation doesn’t distinguish itself from being able to be conducted in
the human mind or with pencil and paper. Therefore, under the broadest reasonable interpretation, this limitation is a process step that covers performance in the human mind or with the aid of pencil and paper. As such, this limitation falls within the “Mental Process” grouping of abstract ideas.
The examiner also notes that the language in the preamble of claim 25 is similar to the language in the recent amendment to claim 25 shown above. The language in the preamble is rejected using the same teachings.

8. Applicants argue:
The applicant argues that the limitation of claim 25 that states “information on the
selection and/or definition and/or setting of an anatomical and/or physiological model of a
patient based on said stored digital data of anatomical and/or physiological modeling” that was
argued in the previous office action is irrelevant, where it doesn’t have anything to do with
MPEP 2106.04(d), which has to do with physical devices that are integral to the claim.
(Remarks: page 14)

9. Examiner Response:
The examiner notes that the physical device that the applicant refers to is the medical
Device and computer platform that is mentioned within claim 25. As mentioned above in section
7 of the current office action, the recent amendment that states “wherein the medical device
is implantable and/or usable on patients” is not stating that the medical device is being
implanted. The recent amendment is stating that the medical device can be implantable and/or
usable on a patient. The limitation doesn’t distinguish itself from being able to be conducted in
the human mind or with pencil and paper. Therefore, under the broadest reasonable interpretation, this limitation is a process step that covers performance in the human mind or with the aid of pencil and paper. As such, this limitation falls within the “Mental Process” grouping of abstract ideas.
The other limitations of claim 25 that include a medical device have been shown in the
previous office action to not be eligible under 35 U.S.C. 101. For example, the storing limitation
of claim 25 that states “storing on a computer platform digital modeling data of medical
device, referred to a medical device which is implantable or usable on a patient, referred to
the whole medical device or a part thereof” amounts to insignificant extra-solution activity of receiving data i.e. pre-solution activity of gathering data for use in the claimed process, see MPEP 2106.05(g).
Also, the claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception. The additional element of the computer platform that applies a judicial exception, such as an abstract idea, by use of conventional computer functions does not qualify as a particular machine, see MPEP 2106.05(b) 1. It is important to note that a general purpose computer that applies a judicial exception, such as an abstract idea, by use of conventional computer functions does not qualify as a particular machine. Ultramercial, Inc. v. Hulu, LLC, 772 F.3d 709, 716-17, 112 USPQ2d 1750, 1755-56 (Fed. Cir. 2014). See also TLI Communications LLC v. AV Automotive LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (mere recitation of concrete or tangible components is not an inventive concept); Eon Corp. IP Holdings LLC v. AT&T Mobility LLC, 785 F.3d 616, 623, 114 USPQ2d 1711, 1715 (Fed. Cir. 2015) (noting that Alappat’s rationale that an otherwise ineligible algorithm or software could be made patent-eligible by merely adding a generic computer to the claim was superseded by the Supreme Court’s Bilski and Alice Corp. decisions).
Further, the claim recites the additional element of a computer platform, where the computer platform is recited at a high level of generality such that it amounts no more than mere instructions to apply the exception using a computer and/or 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.

10. Applicants argue:
The applicant argues that claims 45-47 are not directed towards ineligible subject matter,
where claim 45 recites “implanting the medical device in said real patient and/or operating
on said real patient using the medical device”, claim 46 recites “fitting the patient
with the orthopaedic prosthesis” and claim 47 recites “implanting the device in the patient's
body” (Remarks: pages 15-16)

11. Examiner Response:
The examiner notes that after further consideration claim 45 that states “implanting the
medical device in said real patient and/or operating on said real patient using the medical
device” amounts to mere instructions to apply an exception, where it recites an idea of a solution.
The claim limitation doesn’t state how the medical device is being implanted in the real patient.
See MPEP 2106.05 (f) (1) Whether the claim recites only the idea of a solution or outcome i.e.,
the claim fails to recite details of how a solution to a problem is accomplished. The recitation of
claim limitations that attempt to cover any solution to an identified problem with no restriction
on how the result is accomplished and no description of the mechanism for accomplishing the
result, does not integrate a judicial exception into a practical application or provide significantly
more because this type of recitation is equivalent to the words "apply it".
Also, for claim 46 that states “fitting the patient with the orthopaedic prosthesis”, this
limitation amounts to mere instructions to apply an exception, where it recites an idea of a
solution. The claim limitation doesn’t state how the orthopaedic prosthesis is fitted to the
patient. See MPEP 2106.05 (f) (1) Whether the claim recites only the idea of a solution or
outcome i.e., the claim fails to recite details of how a solution to a problem is accomplished. The
recitation of claim limitations that attempt to cover any solution to an identified problem with no
restriction on how the result is accomplished and no description of the mechanism for
accomplishing the result, does not integrate a judicial exception into a practical application or
provide significantly more because this type of recitation is equivalent to the words "apply it".
Further, for claim 47 that states “implanting the device in the patient's body” this
limitation amounts to mere instructions to apply an exception, where it recites an idea of a
solution. The claim limitation doesn’t state how the device is implanted in the patient’s body.
See MPEP 2106.05 (f) (1) Whether the claim recites only the idea of a solution or
outcome i.e., the claim fails to recite details of how a solution to a problem is accomplished. The
recitation of claim limitations that attempt to cover any solution to an identified problem with no
restriction on how the result is accomplished and no description of the mechanism for
accomplishing the result, does not integrate a judicial exception into a practical application or
provide significantly more because this type of recitation is equivalent to the words "apply it".

Response: 35 U.S.C. § 103
12. Applicants argue:
The applicant argues that the Golway reference doesn’t teach the limitation of claim 25
that states “and wherein the computer platform further comprises a PIDO (Process
Integration and Design Optimization) software program, configured to manage the
workflow of the software programs included in the computer platform and to optimize
computational simulations”, where the ITK of the Golway et al. reference is not the same as the
PIDO (Process Integration and Design Optimization) software program. (Remarks: pages 17-
19)

13. Examiner Response:
The examiner notes that through further consideration, the Dzenis reference teaches the
limitation shown above in section 12 in paragraph [0061]. In paragraph [0061] of the Dzenis et
al. reference it teaches using a treatment selection/optimization evaluation module that employs a
mathematical optimization routine to determine an optimized treatment plan. The examiner
considers the mathematical optimization routine to be a PIDO (Process Integration and
Design Optimization), since the mathematical optimization routine determines an optimized
treatment plan using linear and non-linear programming by evaluating a range of available
treatment options and selecting a treatment that is best suited for a particular patient. The PIDO
creates a unified workflow that is comprised in a computer platform and optimize computational
simulations. The examiner considers the treatment options to be the workflow, where the
treatment options are gathered and ranked to determine the best option for a patient. Also, the
treatment selection/optimization evaluation module is embedded within the computing device.
The examiner considers the computing device to be the computer platform, since the computing
device can be a personal computer, see paragraph [0040] and Fig. 1 of the Dzenis et al.
reference.

Claim Rejections - 35 USC § 101
14. 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 25-31, 33-34, 36, 38-42 and 45-47 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Under the broadest reasonable interpretation, the claims covers performance of the limitation in the mind or by pencil and paper.
Claims 25 and 42
Regarding step 1, claims 25 and 42 are directed towards a method and system, which has the claims fall within the eligible statutory categories of processes, machines, manufactures and composition of matter under 35 U.S.C. 101.
Claim 25
Regarding step 2A, prong 1, claim 25 recites “wherein the selection and/or setting information comprises: information on the selection and/or definition and/or setting of a medical device model”. Under the broadest reasonable interpretation, this limitation is a process step that covers performance in the human mind or with the aid of pencil and paper. As such, this limitation falls within the “Mental Process” grouping of abstract ideas.
Claim 25 recites “information on the selection and/or definition and/or setting of an anatomical and/or physiological model of a patient based on said stored digital data of anatomical and/or physiological modeling”. Under the broadest reasonable interpretation, this limitation is a process step that covers performance in the human mind or with the aid of pencil and paper. As such, this limitation falls within the “Mental Process” grouping of abstract ideas.
Claim 25 recites “information on the selection and setting of a simulation type, and/or information on the selection and setting of one or more input simulation parameters, and one or more output simulation parameters”. Under the broadest reasonable interpretation, this limitation is a process step that covers performance in the human mind or with the aid of pencil and paper. As such, this limitation falls within the “Mental Process” grouping of abstract ideas.
Claim 25 recites “processing, by means of the computer platform, said information on the selection and/or definition and/or setting of a medical device model for preparing a medical device model based on said stored digital data of medical device modeling”. This limitation doesn’t distinguish itself from being able to be conducted in the human mind or with pencil and paper. The language within the specification that further shows that the claim limitation shown above doesn’t distinguish itself from being able to be conducted in the human mind or with pencil and paper, see Pg. 7 lines 18-21 of the specification. Therefore, under the broadest reasonable interpretation, this limitation is a process step that covers performance in the human mind or with the aid of pencil and paper. As such, this limitation falls within the “Mental Process” grouping of abstract ideas.
Claim 25 recites “processing, by means of the computer platform, said information on the selection and/or definition and/or setting of a patient model for preparing an anatomical and/or physiological model of one or more anatomical parts of the patient based on said stored digital data of anatomical and/or physiological modeling”. This limitation doesn’t distinguish itself from being able to be conducted in the human mind or with pencil and paper. The language within the specification that further shows that the claim limitation shown above doesn’t distinguish itself from being able to be conducted in the human mind or with pencil and paper, see Pg. 7 lines 21-24 of the specification. Therefore, under the broadest reasonable interpretation, this limitation is a process step that covers performance in the human mind or with the aid of pencil and paper. As such, this limitation falls within the “Mental Process” grouping of abstract ideas.
Claim 25 recites “processing, by means of the computer platform, said selection and/or setting information entered by the user for preparing input setting data for one or more computational simulation software programs included in the computer platform”. This limitation doesn’t distinguish itself from being able to be conducted in the human mind or with pencil and paper. The language within the specification that further shows that the claim limitation shown above doesn’t distinguish itself from being able to be conducted in the human mind or with pencil and paper, see Pg. 7 lines 24-27 of the specification. Therefore, under the broadest reasonable interpretation, this limitation is a process step that covers performance in the human mind or with the aid of pencil and paper. As such, this limitation falls within the “Mental Process” grouping of abstract ideas.
Claim 25 recites “processing the output data of the computational simulation on the basis of said information on the selection and setting of one or more output simulation parameters, to express simulation results, representative of a functional and/or structural behavior of the medical device and/or patient, in a format selected by the user”. This limitation doesn’t distinguish itself from being able to be conducted in the human mind or with pencil and paper. The language within the specification that further shows that the claim limitation shown above doesn’t distinguish itself from being able to be conducted in the human mind or with pencil and paper, see Pg. 7 lines 31-35 of the specification. Therefore, under the broadest reasonable interpretation, this limitation is a process step that covers performance in the human mind or with the aid of pencil and paper. As such, this limitation falls within the “Mental Process” grouping of abstract ideas.
Claim 25 recites “wherein the computational simulations comprise simulations for the design and/or development of the medical device, and simulations for evaluations of the medical device safety and/or compliance with current regulations.”. Under the broadest reasonable interpretation, this limitation is a process step that covers performance in the human mind or with the aid of pencil and paper. As such, this limitation falls within the “Mental Process” grouping of abstract ideas.
Claim 25 recites “wherein said digital models of medical devices include structured digital data sets designed to digitally represent a device, or device parts, or device properties”. Under the broadest reasonable interpretation, this limitation is a process step that covers performance in the human mind or with the aid of pencil and paper. As such, this limitation falls within the “Mental Process” grouping of abstract ideas.
Claim 25 recites “wherein said one or more software programs or applications of the computer platform comprise: one or more user interface management software programs”. Under the broadest reasonable interpretation, this limitation is a process step that covers performance in the human mind or with the aid of pencil and paper. As such, this limitation falls within the “Mental Process” grouping of abstract ideas.
Claim 25 recites “wherein said one or more software programs or applications of the computer platform comprise: one or more software processing programs, configured to perform said steps of processing the information on the selection and/or definition and/or setting of a medical device model”. This limitation doesn’t distinguish itself from being able to be conducted in the human mind or with pencil and paper, where the claim language doesn’t state that the actual performing of the steps of processing the information is taking place. The claim limitation states that the one or more software can perform the steps of processing information on the selection and/or definition and/or setting of a medical device model. Therefore, under, the broadest reasonable interpretation, this limitation is a process step that covers performance in the human mind or with the aid of pencil and paper. As such, this limitation falls within the “Mental Process” grouping of abstract ideas.
Claim 25 recites “processing the information on the selection and/or definition and/or setting of a patient model”. This limitation doesn’t distinguish itself from being able to be conducted in the human mind or with pencil and paper. The language within the specification that further shows that the claim limitation shown above doesn’t distinguish itself from being able to be conducted in the human mind or with pencil and paper, see Pg. 8 lines 8-9 of the specification. Therefore, under the broadest reasonable interpretation, this limitation is a process step that covers performance in the human mind or with the aid of pencil and paper. As such, this limitation falls within the “Mental Process” grouping of abstract ideas.
Claim 25 recites “processing the selection and/or setting information entered by the user for preparing input setting data for the one or more computational simulation software programs”. This limitation doesn’t distinguish itself from being able to be conducted in the human mind or with pencil and paper. The language within the specification that further shows that the claim limitation shown above doesn’t distinguish itself from being able to be conducted in the human mind or with pencil and paper, where the software programs are not actually performing the processing of the selection and/or setting information entered by the user. The limitation states that the software programs can perform the processing of the selection and/or setting information entered by the user, see Pg. 8 lines 6-7 and lines 9-11 of the specification. Therefore, under the broadest reasonable interpretation, this limitation is a process step that covers performance in the human mind or with the aid of pencil and paper. As such, this limitation falls within the “Mental Process” grouping of abstract ideas.
Claim 25 recites “and processing the output data of the computational simulation to express the desired simulation results”. This limitation doesn’t distinguish itself from being able to be conducted in the human mind or with pencil and paper. The language within the specification that further shows that the claim limitation shown above doesn’t distinguish itself from being able to be conducted in the human mind or with pencil and paper, where the software programs are not actually performing the processing of the output data of the computational simulation. The limitation states that the software programs can perform the processing of the output data of the computational simulation, see Pg. 8 lines 6-7 and lines 11-12 of the specification. Therefore, under the broadest reasonable interpretation, this limitation is a process step that covers performance in the human mind or with the aid of pencil and paper. As such, this limitation falls within the “Mental Process” grouping of abstract ideas.
Claim 25 recites “wherein the computer platform further comprises a PIDO (Process Integration and Design Optimization) software program, configured to manage the workflow of the software programs included in the computer platform”. This limitation doesn’t distinguish itself from being able to be conducted in the human mind or with pencil and paper. The language within the specification that further shows that the claim limitation shown above doesn’t distinguish itself from being able to be conducted in the human mind or with pencil and paper, where a software program (PIDO) is not actually managing the workflow of the software programs included in the computer platform, see Pg. 8 lines 13-16 of the specification. Therefore, under the broadest reasonable interpretation, this limitation is a process step that covers performance in the human mind or with the aid of pencil and paper. As such, this limitation falls within the “Mental Process” grouping of abstract ideas.
Claim 25 recites “wherein the medical device is implantable and/or usable on
patients”. This limitation isn’t stating that the medical device can be implantable and/or
usable on a patient. The limitation doesn’t distinguish itself from being able to be conducted in
the human mind or with pencil and paper. Therefore, under the broadest reasonable interpretation, this limitation is a process step that covers performance in the human mind or with the aid of pencil and paper. As such, this limitation falls within the “Mental Process” grouping of abstract ideas.
Regarding step 2A, prong 2, the limitations of “storing on a computer platform digital modeling data of medical device, referred to a medical device which is implantable or usable on a patient, referred to the whole medical device or a part thereof”; “storing on the computer platform anatomical and/or physiological digital modeling data of a real or virtual patient, referred to one or more anatomical parts of the patient with which the medical device is intended to interact”; “receiving selection and/or setting information which can be entered by the user through the user interface”; “obtaining digital modeling data of a medical device by selecting one or more of a plurality of digital models of medical devices stored in a digital library of the computer platform and/or pre- loaded by the user on the computer platform”; “and obtaining digital modeling data of one or more patients by selecting one or more of a plurality of digital models of real or virtual patients stored in the digital library of the computer platform and/or pre-loaded by the user on the computer platform” amounts to insignificant extra-solution activity of receiving data i.e. pre-solution activity of gathering data for use in the claimed process, see MPEP 2106.05(g).
Also, the limitation of providing, by means of the computer platform, a user interface
which can be connected to the Internet and configured to allow a user to connect and interact with the computer platform of digital data and with one or more software programs included therein amounts to mere instructions to apply an exception, where a generic computer is applying the instruction, see MPEP 2106.05(f) (2) Whether the claim invokes computers or other machinery merely as a tool to perform an existing process. Use of a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not integrate a judicial exception into a practical application or provide significantly more.
Also, the limitation of “executing the computational simulation, by the one or more
computational simulation software programs, on the basis of said input setting data, of said
medical device model and of said anatomical and/or physiological model, to obtain output
data of the computational simulation” amounts to mere instructions to apply an exception,
where it recites an idea of a solution. The limitation is executing the computation simulation
based on the input setting data. See MPEP 2106.05 (f)(1) Whether the claim recites only the
idea of a solution or outcome i.e., the claim fails to recite details of how a solution to a problem
is accomplished. The recitation of claim limitations that attempt to cover any solution to an
identified problem with no restriction on how the result is accomplished and no description of
the mechanism for accomplishing the result, does not integrate a judicial exception into a
practical application or provide significantly more because this type of recitation is equivalent to
the words "apply it".
Also, the limitation of providing the simulation results by means of the user interface amounts to insignificant extra-solution activity of receiving data i.e. pre-solution activity of gathering data for use in the claimed process, see MPEP 2106.05(g).
Also, the claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception. The additional element of the computer platform that applies a judicial exception, such as an abstract idea, by use of conventional computer functions does not qualify as a particular machine, see MPEP 2106.05(b) 1. It is important to note that a general purpose computer that applies a judicial exception, such as an abstract idea, by use of conventional computer functions does not qualify as a particular machine. Ultramercial, Inc. v. Hulu, LLC, 772 F.3d 709, 716-17, 112 USPQ2d 1750, 1755-56 (Fed. Cir. 2014). See also TLI Communications LLC v. AV Automotive LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (mere recitation of concrete or tangible components is not an inventive concept); Eon Corp. IP Holdings LLC v. AT&T Mobility LLC, 785 F.3d 616, 623, 114 USPQ2d 1711, 1715 (Fed. Cir. 2015) (noting that Alappat’s rationale that an otherwise ineligible algorithm or software could be made patent-eligible by merely adding a generic computer to the claim was superseded by the Supreme Court’s Bilski and Alice Corp. decisions).
Further, the claim recites the additional element of a computer platform, where the computer platform is recited at a high level of generality such that it amounts no more than mere instructions to apply the exception using a computer and/or 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.
Regarding Step 2B, the limitations of “storing on a computer platform digital modeling data of medical device, referred to a medical device which is implantable or usable on a patient, referred to the whole medical device or a part thereof”; “storing on the computer platform anatomical and/or physiological digital modeling data of a real or virtual patient, referred to one or more anatomical parts of the patient with which the medical device is intended to interact”; “receiving selection and/or setting information which can be entered by the user through the user interface”; “obtaining digital modeling data of a medical device by selecting one or more of a plurality of digital models of medical devices stored in a digital library of the computer platform and/or pre- loaded by the user on the computer platform”; “and obtaining digital modeling data of one or more patients by selecting one or more of a plurality of digital models of real or virtual patients stored in the digital library of the computer platform and/or pre-loaded by the user on the computer platform” are also shown to reflect the court decisions of Versata Dev. Group, Inc. v. SAP Am., Inc. iv. Storing and retrieving information in memory, shown in MPEP 2106.05(d) (II).
Also, the limitation of providing, by means of the computer platform, a user interface
which can be connected to the Internet and configured to allow a user to connect and interact with the computer platform of digital data and with one or more software programs included therein amounts to mere instructions to apply an exception, where a generic computer is applying the instruction, see MPEP 2106.05(f) (2) Whether the claim invokes computers or other machinery merely as a tool to perform an existing process. Use of a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not integrate a judicial exception into a practical application or provide significantly more.
Also, the limitation of “providing, by means of the computer platform, a user
interface which can be connected to the Internet and configured to allow a user to connect and interact with the computer platform of digital data and with one or more software programs included therein” is merely indicating a field of use. In MPEP 2106.05(h) it states “Thus, limitations that amount to merely indicating a field of use or technological environment in which to apply a judicial exception do not amount to significantly more than the exception itself, and cannot integrate a judicial exception into a practical application”.
Also, the limitation of “executing the computational simulation, by the one or more
computational simulation software programs, on the basis of said input setting data, of said
medical device model and of said anatomical and/or physiological model, to obtain output
data of the computational simulation” amounts to mere instructions to apply an exception,
where it recites an idea of a solution. The limitation is executing the computation simulation
based on the input setting data. See MPEP 2106.05 (f)(1) Whether the claim recites only the
idea of a solution or outcome i.e., the claim fails to recite details of how a solution to a problem
is accomplished. The recitation of claim limitations that attempt to cover any solution to an
identified problem with no restriction on how the result is accomplished and no description of
the mechanism for accomplishing the result, does not integrate a judicial exception into a
practical application or provide significantly more because this type of recitation is equivalent to
the words "apply it".
Also, the limitation of providing the simulation results by means of the user interface is also shown to reflect the court decisions of Versata Dev. Group, Inc. v. SAP Am., Inc. iv. Storing and retrieving information in memory, shown in MPEP 2106.05(d) (II).
Also, the claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception. The additional element of the computer platform that applies a judicial exception, such as an abstract idea, by use of conventional computer functions does not qualify as a particular machine, see MPEP 2106.05(b) 1. It is important to note that a general purpose computer that applies a judicial exception, such as an abstract idea, by use of conventional computer functions does not qualify as a particular machine. Ultramercial, Inc. v. Hulu, LLC, 772 F.3d 709, 716-17, 112 USPQ2d 1750, 1755-56 (Fed. Cir. 2014). See also TLI Communications LLC v. AV Automotive LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (mere recitation of concrete or tangible components is not an inventive concept); Eon Corp. IP Holdings LLC v. AT&T Mobility LLC, 785 F.3d 616, 623, 114 USPQ2d 1711, 1715 (Fed. Cir. 2015) (noting that Alappat’s rationale that an otherwise ineligible algorithm or software could be made patent-eligible by merely adding a generic computer to the claim was superseded by the Supreme Court’s Bilski and Alice Corp. decisions).
Further, 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 element of the computer platform amounts no more than mere instructions to apply the exception using a generic computer component that does not impose any meaningful limits on practicing the abstract idea and therefore cannot provide an inventive concept (See MPEP 2106.05(b).
Claim 42
Regarding step 2A, prong 1, Claim 42 recites “wherein the selection and/or setting information comprises: information on the selection and/or definition and/or setting of a medical device model”. Under the broadest reasonable interpretation, this limitation is a process step that covers performance in the human mind or with the aid of pencil and paper. As such, this limitation falls within the “Mental Process” grouping of abstract ideas.
Claim 42 recites “information on the selection and/or definition and/or setting of an anatomical and/or physiological model of a patient based on said stored digital data of anatomical and/or physiological modeling”. Under the broadest reasonable interpretation, this limitation is a process step that covers performance in the human mind or with the aid of pencil and paper. As such, this limitation falls within the “Mental Process” grouping of abstract ideas.
Claim 42 recites “information on the selection and setting of a simulation type, and/or information on the selection and setting of one or more input simulation parameters, and one or more output simulation parameters”. Under the broadest reasonable interpretation, this limitation is a process step that covers performance in the human mind or with the aid of pencil and paper. As such, this limitation falls within the “Mental Process” grouping of abstract ideas.
Claim 42 recites “processing said information on the selection and/or definition and/or setting of a medical device model for preparing a medical device model based on said stored digital data of functional and/or structural modeling and/or of modeling of the behavior of a medical device”. This limitation doesn’t distinguish itself from being able to be conducted in the human mind or with pencil and paper. The language within the specification that further shows that the claim limitation shown above doesn’t distinguish itself from being able to be conducted in the human mind or with pencil and paper, see Pg. 7 lines 18-21 of the specification. Therefore, under the broadest reasonable interpretation, this limitation is a process step that covers performance in the human mind or with the aid of pencil and paper. As such, this limitation falls within the “Mental Process” grouping of abstract ideas.
Claim 42 recites “processing said information on the selection and/or definition and/or setting of a patient model for preparing an anatomical and/or physiological model of one or more anatomical parts of the patient based on said stored digital data of anatomical and/or physiological modeling”. This limitation doesn’t distinguish itself from being able to be conducted in the human mind or with pencil and paper. The language within the specification that further shows that the claim limitation shown above doesn’t distinguish itself from being able to be conducted in the human mind or with pencil and paper, see Pg. 7 lines 21-24 of the specification. Therefore, under the broadest reasonable interpretation, this limitation is a process step that covers performance in the human mind or with the aid of pencil and paper. As such, this limitation falls within the “Mental Process” grouping of abstract ideas.
Claim 42 recites “processing said selection and/or setting information entered by the user for preparing input setting data for one or more computational simulation software programs included in the computer platform”. This limitation doesn’t distinguish itself from being able to be conducted in the human mind or with pencil and paper. The language within the specification that further shows that the claim limitation shown above doesn’t distinguish itself from being able to be conducted in the human mind or with pencil and paper, see Pg. 7 lines 24-27 of the specification. Therefore, under the broadest reasonable interpretation, this limitation is a process step that covers performance in the human mind or with the aid of pencil and paper. As such, this limitation falls within the “Mental Process” grouping of abstract ideas.
Claim 42 recites “processing the output data of the computational simulation, on the basis of said information on the selection and setting of one or more output simulation parameters, to express simulation results, representative of a functional and/or structural behavior of the medical device and/or patient, in a format selected by the user”. This limitation doesn’t distinguish itself from being able to be conducted in the human mind or with pencil and paper. The language within the specification that further shows that the claim limitation shown above doesn’t distinguish itself from being able to be conducted in the human mind or with pencil and paper, see Pg. 7 lines 31-35 of the specification. Therefore, under the broadest reasonable interpretation, this limitation is a process step that covers performance in the human mind or with the aid of pencil and paper. As such, this limitation falls within the “Mental Process” grouping of abstract ideas.
Claim 42 recites “wherein the computational simulations comprise simulations for the design and/or development of the medical device, and simulations for evaluations of the medical device safety and/or compliance with current regulations”. Under the broadest reasonable interpretation, this limitation is a process step that covers performance in the human mind or with the aid of pencil and paper. As such, this limitation falls within the “Mental Process” grouping of abstract ideas.
Claim 42 recites “wherein said digital models of medical devices include structured digital data sets designed to digitally represent a device, or device parts, or device properties”. Under the broadest reasonable interpretation, this limitation is a process step that covers performance in the human mind or with the aid of pencil and paper. As such, this limitation falls within the “Mental Process” grouping of abstract ideas.
Claim 42 recites “wherein said one or more software programs or applications of the computer platform comprise: one or more user interface management software programs”. Under the broadest reasonable interpretation, this limitation is a process step that covers performance in the human mind or with the aid of pencil and paper. As such, this limitation falls within the “Mental Process” grouping of abstract ideas.
Claim 42 recites “wherein said one or more software programs or applications of the computer platform comprise: one or more computational simulation software programs, configured to perform the computational simulation when executed by a computer”. Under the broadest reasonable interpretation, this limitation is a process step that covers performance in the human mind or with the aid of pencil and paper. As such, this limitation falls within the “Mental Process” grouping of abstract ideas.
Claim 42 recites “wherein said one or more software programs or applications of the computer platform comprise: one or more software processing programs, configured to perform said steps of processing the information on the selection and/or definition and/or setting of a medical device model”. This limitation doesn’t distinguish itself from being able to be conducted in the human mind or with pencil and paper, where the claim language doesn’t state that the actual performing of the steps of processing the information is taking place. The claim limitation states that the one or more software can perform the steps of processing information on the selection and/or definition and/or setting of a medical device model. Therefore, under, the broadest reasonable interpretation, this limitation is a process step that covers performance in the human mind or with the aid of pencil and paper. As such, this limitation falls within the “Mental Process” grouping of abstract ideas.
Claim 42 recites “processing the information on the selection and/or definition and/or setting of a patient model”. This limitation doesn’t distinguish itself from being able to be conducted in the human mind or with pencil and paper. The language within the specification that further shows that the claim limitation shown above doesn’t distinguish itself from being able to be conducted in the human mind or with pencil and paper, see Pg. 8 lines 8-9 of the specification. Therefore, under the broadest reasonable interpretation, this limitation is a process step that covers performance in the human mind or with the aid of pencil and paper. As such, this limitation falls within the “Mental Process” grouping of abstract ideas.
Claim 42 recites “processing the selection and/or setting information entered by the user for preparing input setting data for the one or more computational simulation software programs”. This limitation doesn’t distinguish itself from being able to be conducted in the human mind or with pencil and paper. The language within the specification that further shows that the claim limitation shown above doesn’t distinguish itself from being able to be conducted in the human mind or with pencil and paper, where the software programs are not actually performing the processing of the selection and/or setting information entered by the user. The limitation states that the software programs can perform the processing of the selection and/or setting information entered by the user, see Pg. 8 lines 6-7 and lines 9-11 of the specification. Therefore, under the broadest reasonable interpretation, this limitation is a process step that covers performance in the human mind or with the aid of pencil and paper. As such, this limitation falls within the “Mental Process” grouping of abstract ideas.
Claim 42 recites “and processing the output data of the computational simulation to express the desired simulation results”. This limitation doesn’t distinguish itself from being able to be conducted in the human mind or with pencil and paper. The language within the specification that further shows that the claim limitation shown above doesn’t distinguish itself from being able to be conducted in the human mind or with pencil and paper, where the software programs are not actually performing the processing of the output data of the computational simulation. The limitation states that the software programs can perform the processing of the output data of the computational simulation, see Pg. 8 lines 6-7 and lines 11-12 of the specification. Therefore, under the broadest reasonable interpretation, this limitation is a process step that covers performance in the human mind or with the aid of pencil and paper. As such, this limitation falls within the “Mental Process” grouping of abstract ideas.
Claim 42 recites “wherein the computer platform further comprises a PIDO (Process Integration and Design Optimization) software program, configured to manage the workflow of the software programs included in the computer platform”. This limitation doesn’t distinguish itself from being able to be conducted in the human mind or with pencil and paper. The language within the specification that further shows that the claim limitation shown above doesn’t distinguish itself from being able to be conducted in the human mind or with pencil and paper, where a software program (PIDO) is not actually managing the workflow of the software programs included in the computer platform, see Pg. 8 lines 13-16 of the specification. Therefore, under the broadest reasonable interpretation, this limitation is a process step that covers performance in the human mind or with the aid of pencil and paper. As such, this limitation falls within the “Mental Process” grouping of abstract ideas.
Claim 42 recites “wherein the medical device is implantable and/or usable on
patients”. This limitation isn’t stating that the medical device can be implantable and/or
usable on a patient. The limitation doesn’t distinguish itself from being able to be conducted in
the human mind or with pencil and paper. Therefore, under the broadest reasonable interpretation, this limitation is a process step that covers performance in the human mind or with the aid of pencil and paper. As such, this limitation falls within the “Mental Process” grouping of abstract ideas.
Regarding step 2A, prong 2, the limitations of “a digital library in which the following is stored: digital modeling data of a plurality of medical devices which are implantable or usable on a patient, referred to the medical device, or to a part thereof”; “anatomical and/or physiological digital modeling data of a plurality of real or virtual patients, referred to one or more anatomical parts of the patient with which the medical devices are intended to interact”; “and receiving selection and/or setting information which can be entered by the user by means of the user interface”; “obtaining digital modeling data of a medical device by selecting one or more of a plurality of digital models of medical devices stored in a digital library of the computer platform and/or pre- loaded by the user on the computer platform”; “and obtaining digital modeling data of one or more patients by selecting one or more of a plurality of digital models of real or virtual patients stored in the digital library of the computer platform and/or pre-loaded by the user on the computer platform” amounts to insignificant extra-solution activity of receiving data i.e. pre-solution activity of gathering data for use in the claimed process, see MPEP 2106.05(g).
Also, the limitation of “providing a user interface which can be connected to the Internet and configured to allow a user to connect to and interact with the computer platform of digital data and with one or more software programs included therein” is merely indicating a field of use. In MPEP 2106.05(h) it states “Thus, limitations that amount to merely indicating a field of use or technological environment in which to apply a judicial exception do not amount to significantly more than the exception itself, and cannot integrate a judicial exception into a practical application”.
Also, the limitation of “executing the computational simulation, by the one or more
computational simulation software programs, on the basis of said input setting data, of said
medical device model and of said anatomical and/or physiological model, to obtain output
data of the computational simulation” amounts to mere instructions to apply an exception,
where it recites an idea of a solution. The limitation is executing the computation simulation
based on the input setting data. See MPEP 2106.05 (f)(1) Whether the claim recites only the
idea of a solution or outcome i.e., the claim fails to recite details of how a solution to a problem
is accomplished. The recitation of claim limitations that attempt to cover any solution to an
identified problem with no restriction on how the result is accomplished and no description of
the mechanism for accomplishing the result, does not integrate a judicial exception into a
practical application or provide significantly more because this type of recitation is equivalent to
the words "apply it".
Also, the limitation of providing the simulation results by means of the user interface amounts to insignificant extra-solution activity of receiving data i.e. pre-solution activity of gathering data for use in the claimed process, see MPEP 2106.05(g).
Also, the claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception. The additional elements of the computer platform and one or more electronic processing components that applies a judicial exception, such as an abstract idea, by use of conventional computer functions does not qualify as a particular machine, see MPEP 2106.05(b) 1. It is important to note that a general purpose computer that applies a judicial exception, such as an abstract idea, by use of conventional computer functions does not qualify as a particular machine. Ultramercial, Inc. v. Hulu, LLC, 772 F.3d 709, 716-17, 112 USPQ2d 1750, 1755-56 (Fed. Cir. 2014). See also TLI Communications LLC v. AV Automotive LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (mere recitation of concrete or tangible components is not an inventive concept); Eon Corp. IP Holdings LLC v. AT&T Mobility LLC, 785 F.3d 616, 623, 114 USPQ2d 1711, 1715 (Fed. Cir. 2015) (noting that Alappat’s rationale that an otherwise ineligible algorithm or software could be made patent-eligible by merely adding a generic computer to the claim was superseded by the Supreme Court’s Bilski and Alice Corp. decisions).
Further, the claim recites the additional elements of a computer platform, digital library and one or more electronic processing components, where the computer platform, digital library and one or more electronic processing components are recited at a high level of generality such that it amounts no more than mere instructions to apply the exception using a computer and/or 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.
Regarding Step 2B, the limitations of a digital library in which the following is stored: digital modeling data of a plurality of medical devices which are implantable or usable on a patient, referred to the medical device, or to a part thereof”; “anatomical and/or physiological digital modeling data of a plurality of real or virtual patients, referred to one or more anatomical parts of the patient with which the medical devices are intended to interact”; “and receiving selection and/or setting information which can be entered by the user by means of the user interface”; “obtaining digital modeling data of a medical device by selecting one or more of a plurality of digital models of medical devices stored in a digital library of the computer platform and/or pre- loaded by the user on the computer platform”; “and obtaining digital modeling data of one or more patients by selecting one or more of a plurality of digital models of real or virtual patients stored in the digital library of the computer platform and/or pre-loaded by the user on the computer platform” are also shown to reflect the court decisions of Versata Dev. Group, Inc. v. SAP Am., Inc. iv. Storing and retrieving information in memory, shown in MPEP 2106.05(d) (II).
Also, the limitation of “providing a user interface which can be connected to the Internet and configured to allow a user to connect to and interact with the computer platform of digital data and with one or more software programs included therein” is merely indicating a field of use. In MPEP 2106.05(h) it states “Thus, limitations that amount to merely indicating a field of use or technological environment in which to apply a judicial exception do not amount to significantly more than the exception itself, and cannot integrate a judicial exception into a practical application”.
Also, the limitation of “executing the computational simulation, by the one or more
computational simulation software programs, on the basis of said input setting data, of said
medical device model and of said anatomical and/or physiological model, to obtain output
data of the computational simulation” amounts to mere instructions to apply an exception,
where it recites an idea of a solution. The limitation is executing the computation simulation
based on the input setting data. See MPEP 2106.05 (f)(1) Whether the claim recites only the
idea of a solution or outcome i.e., the claim fails to recite details of how a solution to a problem
is accomplished. The recitation of claim limitations that attempt to cover any solution to an
identified problem with no restriction on how the result is accomplished and no description of
the mechanism for accomplishing the result, does not integrate a judicial exception into a
practical application or provide significantly more because this type of recitation is equivalent to
the words "apply it".
Also, the limitation of providing the simulation results by means of the user interface is also shown to reflect the court decisions of Versata Dev. Group, Inc. v. SAP Am., Inc. iv. Storing and retrieving information in memory, shown in MPEP 2106.05(d) (II).
Also, the limitation of “providing a user interface which can be connected to the Internet and configured to allow a user to connect to and interact with the computer platform of digital data and with one or more software programs included therein” is merely indicating a field of use. In MPEP 2106.05(h) it states “Thus, limitations that amount to merely indicating a field of use or technological environment in which to apply a judicial exception do not amount to significantly more than the exception itself, and cannot integrate a judicial exception into a practical application”.
Also, the limitation of “executing the computational simulation, by the one or more
computational simulation software programs, on the basis of said input setting data, of said
medical device model and of said anatomical and/or physiological model, to obtain output
data of the computational simulation” amounts to mere instructions to apply an exception,
where it recites an idea of a solution. The limitation is executing the computation simulation
based on the input setting data. See MPEP 2106.05 (f)(1) Whether the claim recites only the
idea of a solution or outcome i.e., the claim fails to recite details of how a solution to a problem
is accomplished. The recitation of claim limitations that attempt to cover any solution to an
identified problem with no restriction on how the result is accomplished and no description of
the mechanism for accomplishing the result, does not integrate a judicial exception into a
practical application or provide significantly more because this type of recitation is equivalent to
the words "apply it".
Also, the claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception. The additional elements of the computer platform and one or more electronic processing components that applies a judicial exception, such as an abstract idea, by use of conventional computer functions does not qualify as a particular machine, see MPEP 2106.05(b) 1. It is important to note that a general purpose computer that applies a judicial exception, such as an abstract idea, by use of conventional computer functions does not qualify as a particular machine. Ultramercial, Inc. v. Hulu, LLC, 772 F.3d 709, 716-17, 112 USPQ2d 1750, 1755-56 (Fed. Cir. 2014). See also TLI Communications LLC v. AV Automotive LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (mere recitation of concrete or tangible components is not an inventive concept); Eon Corp. IP Holdings LLC v. AT&T Mobility LLC, 785 F.3d 616, 623, 114 USPQ2d 1711, 1715 (Fed. Cir. 2015) (noting that Alappat’s rationale that an otherwise ineligible algorithm or software could be made patent-eligible by merely adding a generic computer to the claim was superseded by the Supreme Court’s Bilski and Alice Corp. decisions).
Further, 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 element of the computer platform, digital library and one or more electronic processing components amounts no more than mere instructions to apply the exception using a generic computer component that does not impose any meaningful limits on practicing the abstract idea and therefore cannot provide an inventive concept (See MPEP 2106.05(b).
Claim 26
Dependent claim 26 recites “wherein the method is adapted to perform a computational modeling and simulation of the operation and/or behavior of medical devices which are implantable and/or usable on patients”. Under the broadest reasonable interpretation, this limitation is a process step that covers performance in the human mind or with the aid of pencil and paper. As such, this limitation falls within the “Mental Process” grouping of abstract ideas.
Dependent claim 26 recites “and wherein the digital modeling data of medical device are adapted to model the function and/or structure and/or behavior of the medical device which is implantable or usable on a patient, referred to the whole medical device or a part thereof”. Under the broadest reasonable interpretation, this limitation is a process step that covers performance in the human mind or with the aid of pencil and paper. As such, this limitation falls within the “Mental Process” grouping of abstract ideas.

Claim 27
Dependent claim 27 recites “wherein the step of providing a user interface comprises providing a plurality of user- selectable templates, associated with respective types of simulation, amounts to insignificant extra-solution activity of receiving data i.e. pre-solution activity of gathering data for use in the claimed process, see MPEP 2106.05(g).
Dependent claim 27 recites “wherein each template comprises: - a plurality of input parameters which can be selected for the simulation, each parameter being associated with a respective range of permitted values, within which a parameter value can be set”. Under the broadest reasonable interpretation, this limitation is a process step that covers performance in the human mind or with the aid of pencil and paper. As such, this limitation falls within the “Mental Process” grouping of abstract ideas.
Dependent claim 27 recites “a plurality of selectable output parameters, comprising the desired quantities as an output result”. Under the broadest reasonable interpretation, this limitation is a process step that covers performance in the human mind or with the aid of pencil and paper. As such, this limitation falls within the “Mental Process” grouping of abstract ideas.
Dependent claim 27 recites “a plurality of displaying and reporting options, which can be selected by the user to choose the format of the results and/or the methods to analyze the results”. Under the broadest reasonable interpretation, this limitation is a process step that covers performance in the human mind or with the aid of pencil and paper. As such, this limitation falls within the “Mental Process” grouping of abstract ideas.
Claim 28
Dependent claim 28 recites “wherein the selection and/or setting information which can be entered by the user further comprises parameters for the definition and/or specialization of the digital model of the medical device”. Under the broadest reasonable interpretation, this limitation is a process step that covers performance in the human mind or with the aid of pencil and paper. As such, this limitation falls within the “Mental Process” grouping of abstract ideas.
Dependent claim 28 recites “and/or wherein the selection and/or setting information which can be entered by the user further comprises parameters for defining and/or customizing the anatomical and/or physiological digital model of one or more real or virtual patients”. Under the broadest reasonable interpretation, this limitation is a process step that covers performance in the human mind or with the aid of pencil and paper. As such, this limitation falls within the “Mental Process” grouping of abstract ideas.
Claim 29
Dependent claim 29 recites “wherein the selection and/or setting information which can be entered by the user further comprises parameters for selecting and/or defining real or virtual patients, or populations of real or virtual patients”. Under the broadest reasonable interpretation, this limitation is a process step that covers performance in the human mind or with the aid of pencil and paper. As such, this limitation falls within the “Mental Process” grouping of abstract ideas.
Claim 30
Dependent claim 30 recites “wherein the selection and/or setting information which can be entered by the user further includes geometric parameters and/or parameters related to the properties of the medical device materials”. Under the broadest reasonable interpretation, this limitation is a process step that covers performance in the human mind or with the aid of pencil and paper. As such, this limitation falls within the “Mental Process” grouping of abstract ideas.
Claim 31
Dependent claim 31 recites “wherein the selection and/or setting information which can be entered by the user comprises parameters for setting computational aspects of the simulation, and moreover initial conditions and boundary conditions for the simulation, and/or parameters related to the numerical method used by the computational simulation software”. Under the broadest reasonable interpretation, this limitation is a process step that covers performance in the human mind or with the aid of pencil and paper. As such, this limitation falls within the “Mental Process” grouping of abstract ideas.
Claim 33
Dependent claim 33 recites “wherein the digital modeling data of a real patient are anonymized and/or de-identified and/or pseudonymized”. Under the broadest reasonable interpretation, this limitation is a process step that covers performance in the human mind or with the aid of pencil and paper. As such, this limitation falls within the “Mental Process” grouping of abstract ideas.
Claim 34
Dependent claim 34 recites “wherein the computational simulation comprises structural and/or fluid-dynamic and/or thermal and/or electromagnetic and/or biomechanical simulations”. Under the broadest reasonable interpretation, this limitation is a process step that covers performance in the human mind or with the aid of pencil and paper. As such, this limitation falls within the “Mental Process” grouping of abstract ideas.

Claim 36
Dependent claim 36 recites “wherein the computational simulations comprise simulations for the analysis and prediction of the behavior of the medical device on a population of real or virtual patients, and/or wherein the computational simulations comprise simulations for a customized evaluation of the effects of the medical device on a specific real or virtual patient.”. Under the broadest reasonable interpretation, this limitation is a process step that covers performance in the human mind or with the aid of pencil and paper. As such, this limitation falls within the “Mental Process” grouping of abstract ideas.
Claim 38
Dependent claim 38 recites “wherein the medical device is an orthopaedic prosthesis, the orthopaedic prosthesis model comprises a three-dimensional structural model, the anatomical model of the patient comprises a three-dimensional physiological model”. Under the broadest reasonable interpretation, this limitation is a process step that covers performance in the human mind or with the aid of pencil and paper. As such, this limitation falls within the “Mental Process” grouping of abstract ideas.
Dependent claim 38 recites “and the simulation comprises structural simulations of the mechanical behavior of the implanted medical device and/or of the biomechanical response of the patient to the implanted device”. Under the broadest reasonable interpretation, this limitation is a process step that covers performance in the human mind or with the aid of pencil and paper. As such, this limitation falls within the “Mental Process” grouping of abstract ideas.

Claim 39
Dependent claim 39 recites “wherein the medical device is an endovascular device, the model of the endovascular device comprises a fluid-dynamic model”. Under the broadest reasonable interpretation, this limitation is a process step that covers performance in the human mind or with the aid of pencil and paper. As such, this limitation falls within the “Mental Process” grouping of abstract ideas.
Dependent claim 39 recites “and the simulation comprises a fluid-dynamic simulation of the blood flow”. Under the broadest reasonable interpretation, this limitation is a process step that covers performance in the human mind or with the aid of pencil and paper. As such, this limitation falls within the “Mental Process” grouping of abstract ideas.
Claim 40
Dependent claim 40 recites “wherein the medical device is a device which can be implanted in the patient’s body, the model of the implantable device comprises a behavioral and/or thermal model under electromagnetic field effect”. Under the broadest reasonable interpretation, this limitation is a process step that covers performance in the human mind or with the aid of pencil and paper. As such, this limitation falls within the “Mental Process” grouping of abstract ideas.
Dependent claim 40 recites “and the simulation comprises an electromagnetic simulation adapted to simulate the effect of the electromagnetic field on the temperature variation of the patient’s tissues and/or on the behavior of the device.”. Under the broadest reasonable interpretation, this limitation is a process step that covers performance in the human mind or with the aid of pencil and paper. As such, this limitation falls within the “Mental Process” grouping of abstract ideas.
Claim 41
Dependent claim 41 recites “wherein the medical device is an implantable drug-releasing device, the model of the implantable device comprises a fluid-dynamic model, the anatomical and/or physiological model comprises a parameter related to permeability, and the simulation comprises fluid-dynamic and/or functional simulations.”. Under the broadest reasonable interpretation, this limitation is a process step that covers performance in the human mind or with the aid of pencil and paper. As such, this limitation falls within the “Mental Process” grouping of abstract ideas.
Claim 45
Dependent claim 45 recites “wherein said anatomical and/or physiological digital modelling data of a real or virtual patient is of a real patient”. Under the broadest reasonable interpretation, this limitation is a process step that covers performance in the human mind or with the aid of pencil and paper. As such, this limitation falls within the “Mental Process” grouping of abstract ideas.
Dependent claim 45 recites “and further comprising implanting the medical device in said real patient and/or operating on said real patient using the medical device”, amounts to mere instructions to apply an exception, where it recites an idea of a solution.
The claim limitation doesn’t state how the medical device is being implanted in the real patient.
See MPEP 2106.05 (f) (1) Whether the claim recites only the idea of a solution or outcome i.e.,
the claim fails to recite details of how a solution to a problem is accomplished. The recitation of
claim limitations that attempt to cover any solution to an identified problem with no restriction
on how the result is accomplished and no description of the mechanism for accomplishing the
result, does not integrate a judicial exception into a practical application or provide significantly
more because this type of recitation is equivalent to the words "apply it".
Claim 46
Dependent claim 46 recites “fitting the patient with the orthopaedic prosthesis”. This
limitation amounts to mere instructions to apply an exception, where it recites an idea of a
solution. The claim limitation doesn’t state how the orthopaedic prosthesis is fitted to the
patient. See MPEP 2106.05 (f) (1) Whether the claim recites only the idea of a solution or
outcome i.e., the claim fails to recite details of how a solution to a problem is accomplished. The
recitation of claim limitations that attempt to cover any solution to an identified problem with no
restriction on how the result is accomplished and no description of the mechanism for
accomplishing the result, does not integrate a judicial exception into a practical application or
provide significantly more because this type of recitation is equivalent to the words "apply it".
Claim 47
Dependent claim 47 recites “implanting the device in the patient’s body”. This
limitation amounts to mere instructions to apply an exception, where it recites an idea of a
solution. The claim limitation doesn’t state how the device is implanted in the patient’s body.
See MPEP 2106.05 (f) (1) Whether the claim recites only the idea of a solution or
outcome i.e., the claim fails to recite details of how a solution to a problem is accomplished. The
recitation of claim limitations that attempt to cover any solution to an identified problem with no
restriction on how the result is accomplished and no description of the mechanism for
accomplishing the result, does not integrate a judicial exception into a practical application or
provide significantly more because this type of recitation is equivalent to the words "apply it".
Claims 25-31, 33-34, 36, 38-42 and 45-47 are therefore not drawn to eligible subject matter as they are directed to an abstract idea without significantly more.
Claim Rejections - 35 USC § 103
15. 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.
Claim 25-31, 33-34, 36, 38-39 and 42 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dzenis et al. (U.S PGPub 2012/0084064) (from IDS dated 11/20/20) in view of Toly (U.S. PGPub 2004/0126746) in further view of Zhao et al. (U.S. PGPub 2003/0045786) in further view of Anderson et al. (U.S. PGPub 2002/0168618) in further view of Golway et al. (U.S. PGPub 2015/0105891).

With respect to claim 25, Dzenis et al. discloses “- storing on a computer platform digital modeling data of medical device, referred to a medical device which is implantable or usable on a patient, referred to the whole medical device or a part thereof” as [Dzenis et al. (paragraph [0043] “The database 12 is expandable and scalable, allowing for the addition of new data such as tissue histology, tissue models, medical devices, and newly discovered medical record data.”, Fig. 1)];
“- storing on the computer platform anatomical and/or physiological digital modeling data of a real or virtual patient, referred to one or more anatomical parts of the patient with which the medical device is intended to interact” as [Dzenis et al. (paragraph [0041] “The database 12 can also be configured to store simultaneous electrocardiogram (ECG) recordings, recordings of blood flow evaluations and other physiologic data acquired from the patients 22, 24”, Fig. 1, The database can store physiologic data, which demonstrates that physiological data is being stored)];
“- providing, by means of the computer platform, a user interface which can be connected to the Internet and configured to allow a user to connect and interact with the computer platform of digital data and with one or more software programs included therein” as [Dzenis et al. (paragraph [0071] “In some embodiments, an interactive graphical user interface (GUI) 90 can be used by the users 20, 30 for analyzing data generated by the biomechanical model 31 and/or the various modules 32. In certain embodiments, for example, the graphical user interface 90 can be used by surgeons and health care professionals for preoperative analysis, evaluation, and visualization of treatment outcomes for individual patients or groups of patients, or for optimizing potential treatment options.”, Dzenis et al. (paragraph [0072] “The graphical user interface 90 includes database tools 91 for use in performing various database operations, model assembly tools 92 for use in generating models, simulation control tools 93 for use in performing biomechanics modeling and simulation operations, output analysis and visualization tools 94 for performing analyses on outputs generated by the evaluation unit 14, and optimization control tools 95 for use in optimizing outputs generated by the evaluation unit 14”, Fig. 1 item 90)];
“- receiving selection and/or setting information which can be entered by the user through the user interface, wherein the selection and/or setting information comprises: information on the selection and/or definition and/or setting of a medical device model” as [Dzenis et al. (paragraph [0061] “Example treatment parameters that can be optimized via the module 78 comprise the type of treatment, the type of stent/graft material, the base geometry of the stent/graft, placement location, and attachment location/configuration. In use, the treatment selection/optimization evaluation module 78 employs a mathematical optimization routine using linear or non-linear programming techniques to automatically determine an optimized treatment plan based on the available data stored in the database 12. In some embodiments, the treatment selection/optimization evaluation module 78 continuously varies one or more discretionary variables based on user input preferences. For example, one or more surgeon-defined variables can be used as inputs by the treatment selection/optimization evaluation module 78 to determine an optimized treatment option that takes into account the surgeon's experience and preferences.”, Dzenis et al. [0062] “In some embodiments, the optimization of a particular treatment option can be performed by the treatment selection/optimization evaluation module 78 by visually evaluating the output from a graphical user interface (GUI) 90. Furthermore, and in some embodiments, the treatment selection/optimization evaluation module 78 can also be used to quantitatively compare outputs from several possible treatment options based on appropriate selection criteria.”)];
“information on the selection and/or definition and/or setting of an anatomical and/or physiological model of a patient based on said stored digital data of anatomical and/or physiological modeling” as [Dzenis et al. (paragraph [0037] “Model-based systems and methods that utilize patient-specific physiological data and/or previously acquired data from other, similarly situated patients or cases can be used to analyze, and in some cases predict, various parameters for determining a suitable course of treatment for a patient. These systems and methods can also be used as a tool for selecting medical devices tailored to a patient's particular medical condition, or for developing new medical devices. In some embodiments, the patient-specific and/or previously acquired input data can be classified and stored in one or more computer databases that can be accessed by individuals over a computer or computer network.”, Dzenis et al. paragraph [0047] “The biomechanical model 31 can be used for predicting outputs associated with humans, animals, or both. In some embodiments, for example, the biomechanical model 31 employs an animal model for evaluating and predicting various outputs related to vascular interventions and reconstructions in animals such as rats, dogs, or pigs. Information acquired from the animal model may provide users 20, 30 with information for researching both the underlying mechanisms of diseases such as atherosclerosis as well as assisting in the development of improved materials, devices, and treatment methods. The biomechanical model 31 can employ semi-destructive, destructive, or non-invasive techniques for evaluating animals, either in vivo or postmortem. Simulated results from the biomechanical model 31 can be compared to data obtained and stored in the database 12.”, Dzenis et al. paragraph [0093] “FIG. 7 is a schematic view showing several example input parameters 68 for use by the medical device geometry evaluation module 38 in analyzing the geometry of a medical device such as a graft or stent. As shown in FIG. 7, the medical device geometry evaluation module 40 receives, as input parameters 68, a graft/stent type input parameter 166 and a graft/stent dimensions input parameter 168. The graft/stent type input parameter 166 relates to the type and/or manufacturer of the device……One or more other measured or modeled input parameters 170 can also be received for analysis by the medical device geometry evaluation module 38., Fig. 7)];
“information on the selection and setting of a simulation type, and/or information on the selection and setting of one or more input simulation parameters, and one or more output simulation parameters” as [Dzenis et al. (paragraph [0107] “The system next prompts the user to select treatment and/or medical device data to be associated with a proposed treatment option (block 234). The user then performs a search of the database and obtains model parameters to be associated with the biomechanical model (block 236). If, for example, the user desires to use finite element analysis to analyze the effects of pulsatile blood flow on an endarterectomized blood vessel, the user may select the model type from a display screen, and select from a number of finite element analysis options available for the modeling.”, The examiner considers model parameters to be the input simulation parameters, since the model parameters are associated with the biochemical model)];
“- processing, by means of the computer platform, said information on the selection and/or definition and/or setting of a medical device model for preparing a medical device model based on said stored digital data of medical device modeling” as [Dzenis et al. (paragraph [0093] “As shown in FIG. 7, the medical device geometry evaluation module 40 receives, as input parameters 68, a graft/stent type input parameter 166 and a graft/stent dimensions input parameter 168. The graft/stent type input parameter 166 relates to the type and/or manufacturer of the device.”, Dzenis et al. [0094] “Based on the input parameters 64, three-dimensional imaging data/reconstructions and other factors are used by the medical device geometry evaluation module 38 to generate one or more outputs 172 associated with the graft or stent geometry. Examples of outputs 172 that can be evaluated comprise raw data 172a and three-dimensional interpolated data 172b.”)];
“- processing, by means of the computer platform, said information on the selection and/or definition and/or setting of a patient model for preparing an anatomical and/or physiological model of one or more anatomical parts of the patient based on said stored digital data of anatomical and/or physiological modeling” as [Dzenis et al. (paragraph [0039] “Although various example systems and methods are described herein with respect to vascular interventions and reconstructions, the systems and methods can be used to analyze and model other types of physiological conditions and can be used to evaluate other treatment options or to develop other types of medical devices.”, Dzenis et al. paragraph [0059] “In some embodiments, the restenosis prediction module 76 comprises a model that links computed mechanical and hemodynamic parameters to atherogenesis. Various physiological and biochemical phenomena accompanying restenosis can also be incorporated into the restenosis prediction module 76. For example, the restenosis prediction module 76 can model mechanotransduction and the effects of mechanical stimuli on migration of endothelial cells (e.g. via the wound-healing model), the effects of stresses and high uniaxial/biaxial strains on SMC signaling, alignment, or apoptosis, various biochemical processes triggered by stress and strain induced gene expressions, as well as other physiological and biochemical phenomena.”)];
“- processing, by means of the computer platform, said selection and/or setting information entered by the user for preparing input setting data for one or more computational simulation software programs included in the computer platform” as [Dzenis et al. (paragraph [0093] “FIG. 7 is a schematic view showing several example input parameters 68 for use by the medical device geometry evaluation module 38 in analyzing the geometry of a medical device such as a graft or stent. As shown in FIG. 7, the medical device geometry evaluation module 40 receives, as input parameters 68, a graft/stent type input parameter 166 and a graft/stent dimensions input parameter 168.”, Fig. 7)];
“- executing the computational simulation, by the one or more computational simulation software programs, on the basis of said input setting data, of said medical device model and of said anatomical and/or physiological model, to obtain output data of the computational simulation” as [Dzenis et al. (paragraph [0093] “One or more other measured or modeled input parameters 170 can also be received for analysis by the medical device geometry evaluation module 38”, Dzenis et al. [0094] “Based on the input parameters 64, three-dimensional imaging data/reconstructions and other factors are used by the medical device geometry evaluation module 38 to generate one or more outputs 172 associated with the graft or stent geometry. Examples of outputs 172 that can be evaluated comprise raw data 172a and three-dimensional interpolated data 172b.”, Fig. 7)];
“- processing the output data of the computational simulation on the basis of said information on the selection and setting of one or more output simulation parameters, to express simulation results, representative of a functional and/or structural behavior of the medical device and/or patient, in a format selected by the user” as [Dzenis et al. (paragraph [0078] “The graphical user interface 90 can be used to quantitatively and/or qualitatively evaluate certain conditions based on appropriate selected criteria. The selection criteria can be based, for example, on absolute maximum or temporal mean or cyclic values of stress and/or strain intensities in the vessel walls, relative (e.g., percentage) increases in such intensities compared to the vessel before repair or to a healthy vessel, blood flow velocity characteristics (e.g., stagnation points), and wall shear stress. The processor 18 is configured to find critical spots, calculate their extent, and color-code them onto three-dimensional visualization outputs, such as graphs and videos, that can be displayed on the graphical user interface 90 for analysis.”, Dzenis et al. paragraph [0094] “Based on the input parameters 64, three-dimensional imaging data/reconstructions and other factors are used by the medical device geometry evaluation module 38 to generate one or more outputs 172 associated with the graft or stent geometry.”, Fig. 7)];
“- providing the simulation results by means of the user interface.” as [Dzenis et al. (Fig. 1, The results being displayed on the GUI)];
“and wherein the computer platform further comprises a PIDO (Process Integration
and Design Optimization) software program, configured to manage the workflow of the
software programs included in the computer platform and to optimize computational
simulations” as [Dzenis et al. [0061] “The treatment selection/optimization evaluation module
78 is configured for use in evaluating a range of available treatment options and for selecting a
treatment that is best suited for a particular patient. Example treatment parameters that can be
optimized via the module 78 comprise the type of treatment, the type of stent/graft material, the
base geometry of the stent/graft, placement location, and attachment location/configuration. In
use, the treatment selection/optimization evaluation module 78 employs a mathematical
optimization routine using linear or non-linear programming techniques to automatically
determine an optimized treatment plan based on the available data stored in the database 12. In
some embodiments, the treatment selection/optimization evaluation module 78 continuously
varies one or more discretionary variables based on user input preferences.”, The examiner
considers the mathematical optimization routine to be a PIDO (Process Integration and
Design Optimization), since the mathematical optimization routine determines an optimized
treatment plan using linear and non-linear programming by evaluating a range of available
treatment options and selecting a treatment that is best suited for a particular patient.)];
While Dzenis et al. teaches storing digital modeling data of a medical device, Dzenis et al. does not explicitly disclose “A method for functional and/or structural computational modeling and simulation of medical devices which are implantable and/or usable on patients”
Toly discloses “A method for functional and/or structural computational modeling and simulation of medical devices which are implantable and/or usable on patients” as [Toly (paragraph [0204] “A distal end of simulated tool 496 includes an inductor 498……. Once simulated medical instrument 496 is inserted into esophagus 482 and inductor 498 is energized, the position of the distal end of simulated medical instrument 496 (i.e., the position of inductor 498) can be determined by monitoring the plurality of conductive elastomer-based evaluation circuits 490.”, Fig. 22b item 496, The examiner considers the simulation tool to be the medical device, since the simulation tool is used as a medical device)];
Dzenis et al. and Toly are analogous art because they are from the same field endeavor of analyzing medical procedures for a patient.
Before the effective filing date of the invention, it would have been obvious to a person of ordinary skill in the art to modify the teachings of Dzenis et al. of storing digital modeling data of a medical device by incorporating a method for functional and/or structural computational modeling and simulation of medical devices which are implantable and/or usable on patients as taught by Toly for the purpose of simulating a patient’s organ that includes a pressure-sensitive conductive elastomer.
Dzenis et al. in view of Toly teaches a method for functional and/or structural computational modeling and simulation of medical devices which are implantable and/or usable on patients.
The motivation for doing so would have been because Toly teaches that by simulating a patient’s organ, the ability to evaluate a trainee’s ability to manipulate the simulated organ can be accomplished, which allows the trainee to see the tactile sensations of the elastomeric materials with which the conductive elastomer is used (Toly (paragraph [0010] – [0011]).
While the combination of Dzenis et al. and Toly teaches a method for functional and/or
structural computational modeling and simulation of medical devices which are implantable
and/or usable on patients, Dzenis et al. and Toly does not explicitly disclose “wherein the
computational simulations comprise simulations for the design and/or development of the
medical device, and simulations for evaluations of the medical device safety and/or compliance
with current regulations; wherein the medical device is implantable and/or usable on
patients”
Zhao et al. discloses “wherein the computational simulations comprise simulations for the design and/or development of the medical device” as [Zhao et al. (paragraph [0052] “In one embodiment, the global FEA modeling is used to simulate the interaction between a lead 114, lead delivery system, and the heart or cardiac veins during implant or explant of a component of a medical implant system.”)];
“and simulations for evaluations of the medical device safety and/or compliance with current regulations” as [Zhao et al. (paragraph [0052] “The global FEA modeling can also be used to evaluate structural performance for developing product design concepts, identifying device implant or explant procedures, and improving quality and reliability of a device to be used in conjunction with the medical implant system”, The examiner considers the improving quality and reliability of a device to be used in conjunction with the medical implant system as being the simulations for compliance with current regulations, since for the quality and reliability of the device to be in conjunction with the medical implant system, it would have to fit a certain criteria that the medical implant system is operating on)];
“wherein the medical device is implantable and/or usable on patients” as [Zhao et al. (paragraph [0030] “FIG. 1A illustrates one embodiment of implementing an implantable medical system to implant an implantable medical device into a human body. A sensor 190 (e.g., leads) placed upon the heart 120 of the human body 105 is used to acquire and process physiological data. An implantable medical unit 195 collects and processes a plurality of data acquired from the human body. In one embodiment, the implantable medical unit 195 may be implemented in a pacemaker 110.”, Fig. 1A)];
Dzenis et al., Toly and Zhao et al. are analogous art because they are from the same field endeavor of analyzing medical procedures for a patient.
Before the effective filing date of the invention, it would have been obvious to a person
of ordinary skill in the art to modify the teachings of Dzenis et al. and Toly of having a method
for functional and/or structural computational modeling and simulation of medical devices which
are implantable and/or usable on patients by incorporating wherein the computational
simulations comprise simulations for the design and/or development of the medical device, and
simulations for evaluations of the medical device safety and/or compliance with current
regulations; wherein the medical device is implantable and/or usable on patients as taught by
Zhao et al. for the purpose of performing an efficient analysis of structures relating to
implantable medical devices.
Dzenis et al. in view of Toly in further view of Zhao et al. teaches wherein the computational simulations comprise simulations for the design and/or development of the medical device, and simulations for evaluations of the medical device safety and/or compliance with current regulations; wherein the medical device is implantable and/or usable on patients.
The motivation for doing so would have been because Zhao et al. teaches that performing an efficient analysis of structures relating to implantable medical devices, the ability to not delay the delivery of new and innovative products can be accomplished, which allows a physician to receive these innovative products in an efficient time (Zhao et al. (paragraph [0010] – [0012]).
While the combination of Dzenis et al., Toly and Zhao et al. teaches selecting medical devices that are tailored to a patient’s medical condition, where the patient-based treatment outcomes that are associated with a medical device are predicted, Dzenis et al., Toly and Zhao et al. do not explicitly disclose “obtaining digital modeling data of a medical device by selecting one or more of a plurality of digital models of medical devices stored in a digital library of the computer platform and/or pre- loaded by the user on the computer platform, wherein said digital models of medical devices include structured digital data sets designed to digitally represent a device, or device parts, or device properties; and obtaining digital modeling data of one or more patients by selecting one or more of a plurality of digital models of real or virtual patients stored in the digital library of the computer platform and/or pre-loaded by the user on the computer platform”
Anderson et al. discloses “obtaining digital modeling data of a medical device by selecting one or more of a plurality of digital models of medical devices stored in a digital library of the computer platform and/or pre- loaded by the user on the computer platform” as [Anderson et al. (paragraph [0125] “a device modeling system for modeling a three-dimensional representation of one or more medical devices”, Anderson et al. paragraph [0211] “The system provides a library of 3D representations of medical devices and a library of 3D representations of normal or pathological patient anatomy. In one aspect, the user can select an entry point for insertion of a medical device into a simulated patient (e.g., at either a radial or femoral site) and in response to the user's manipulation, a haptic display will display the navigation of the device through a selected body cavity or lumen”)];
“wherein said digital models of medical devices include structured digital data sets designed to digitally represent a device, or device parts, or device properties” as [Anderson et al. (paragraph [0125] “a device modeling system for modeling a three-dimensional representation of one or more medical devices”, Anderson et al. paragraph [0211] “The system provides a library of 3D representations of medical devices and a library of 3D representations of normal or pathological patient anatomy. In one aspect, the user can select an entry point for insertion of a medical device into a simulated patient (e.g., at either a radial or femoral site) and in response to the user's manipulation, a haptic display will display the navigation of the device through a selected body cavity or lumen”)];
“and obtaining digital modeling data of one or more patients by selecting one or more of a plurality of digital models of real or virtual patients stored in the digital library of the computer platform and/or pre-loaded by the user on the computer platform” as [Anderson et al. (paragraph [0125] “In a preferred aspect, the system comprises a geometric modeling system for modeling a three-dimensional representation of a body lumen or cavity”, Anderson et al. paragraph [0211] “The system provides a library of 3D representations of medical devices and a library of 3D representations of normal or pathological patient anatomy. In one aspect, the user can select an entry point for insertion of a medical device into a simulated patient (e.g., at either a radial or femoral site) and in response to the user's manipulation, a haptic display will display the navigation of the device through a selected body cavity or lumen”)];
Dzenis et al., Toly, Zhao et al. and Anderson et al. are analogous art because they are from the same field endeavor of analyzing medical procedures for a patient.
Before the effective filing date of the invention, it would have been obvious to a person of ordinary skill in the art to modify the teachings of Dzenis et al., Toly and Zhao et al. of selecting medical devices that are tailored to a patient’s medical condition, where the patient-based treatment outcomes that are associated with a medical device are predicted by incorporating obtaining digital modeling data of a medical device by selecting one or more of a plurality of digital models of medical devices stored in a digital library of the computer platform and/or pre- loaded by the user on the computer platform, wherein said digital models of medical devices include structured digital data sets designed to digitally represent a device, or device parts, or device properties; and obtaining digital modeling data of one or more patients by selecting one or more of a plurality of digital models of real or virtual patients stored in the digital library of the computer platform and/or pre-loaded by the user on the computer platform as taught by Anderson et al. for the purpose of simulating image-guided medical procedures.
Dzenis et al. in view of Toly in further view of Zhao et al. in further view of Anderson et al. teaches obtaining digital modeling data of a medical device by selecting one or more of a plurality of digital models of medical devices stored in a digital library of the computer platform and/or pre- loaded by the user on the computer platform, wherein said digital models of medical devices include structured digital data sets designed to digitally represent a device, or device parts, or device properties; and obtaining digital modeling data of one or more patients by selecting one or more of a plurality of digital models of real or virtual patients stored in the digital library of the computer platform and/or pre-loaded by the user on the computer platform.
The motivation for doing so would have been because Anderson et al. teaches that having a realistic simulation environment for training and pretreatment planning of image-guided medical procedures, the ability to have physicians properly navigate, orient or position catheters and/or other medical devices within a patient can be accomplish, which allows physicians to properly recognize an anatomic area or pathology that is to be treated (Anderson et al. (paragraph [0004], paragraph [0011])).
While the combination of Dzenis et al., Toly, Zhao et al. and Anderson et al. teaches having a computer platform that has a user interface and one or more computational simulation software programs, Dzenis et al., Toly, Zhao et al. and Anderson et al. do not explicitly disclose “wherein said one or more software programs or applications of the computer platform comprise: - one or more user interface management software programs; - one or more computational simulation software programs, configured to perform the computational simulation when executed by a computer; - one or more software processing programs, configured to perform said steps of processing the information on the selection and/or definition and/or setting of a medical device model, processing the information on the selection and/or definition and/or setting of a patient model, processing the selection and/or setting information entered by the user for preparing input setting data for the one or more computational simulation software programs, and processing the output data of the computational simulation to express the desired simulation results.”
Golway et al. discloses “wherein said one or more software programs or applications of the computer platform comprise: - one or more user interface management software programs” as [Golway et al. (paragraph [0009] “The tissue modeling component comprises a user interface, at least one suite of tools for performing an object operation selected from the operation categories of creating, editing, modeling, transforming, image property modulating, sketching, print supporting, simulating, material testing and combinations thereof, a material database, and software executable by a machine to facilitate a method for designing a volumetric model of a biological construct at the user interface.”, Golway et al. paragraph [0041] “Generally, TSIM comprises software and a user interface comprising an object modeling environment. TSIM comprises several suites of tools for performing one or more object operations. Object modeling tools include but are not limited to tool suites for creating, editing, modeling, transforming, image property modulating, sketching, print supporting, simulating, material testing and combinations thereof.”)];
“- one or more computational simulation software programs, configured to perform the computational simulation when executed by a computer” as [Golway et al. (paragraph [0041] “Generally, TSIM comprises software and a user interface comprising an object modeling environment. TSIM comprises several suites of tools for performing one or more object operations.”)];
“- one or more software processing programs, configured to perform said steps of processing the information on the selection and/or definition and/or setting of a medical device model” as [Golway et al. (paragraph [0051] “Data generated from medical imaging technology is imported to TSIM, analyzed, and used to generate 3-D models or model scaffolds and/or tissue constructs customized to be patient-specific. In certain embodiments, tissues, organs, medical devices and medical jigs may be modeled and fabricated clinically in situ based on specific needs of a patient.”)];
“processing the information on the selection and/or definition and/or setting of a patient model” as [Golway et al. (paragraph [0051] “Data generated from medical imaging technology is imported to TSIM, analyzed, and used to generate 3-D models or model scaffolds and/or tissue constructs customized to be patient-specific. In certain embodiments, tissues, organs, medical devices and medical jigs may be modeled and fabricated clinically in situ based on specific needs of a patient.”, The generating the 3D models that are customized to a specific patient, demonstrates that there the information on the selection and/or definition and/or setting is processed)];
“processing the selection and/or setting information entered by the user for preparing input setting data for the one or more computational simulation software programs” as [Golway et al. (paragraph [0068] “According to a second workflow, users create models using basic shapes. In one aspect of the second workflow, a basic set of geometric shapes is available to users (e.g., cube, cylinder, sphere, pyramid), all of which can be selected and placed directly into the object modeling environment and combined, stretched and deformed to meet specific application needs. In addition, manipulation commands such as *Difference, *Intersect, and *Union are available for the user to create a desired shape”)]
“and processing the output data of the computational simulation to express the desired simulation results” as [Golway et al. (paragraph [0068] “According to a second workflow, users create models using basic shapes. In one aspect of the second workflow, a basic set of geometric shapes is available to users (e.g., cube, cylinder, sphere, pyramid), all of which can be selected and placed directly into the object modeling environment and combined, stretched and deformed to meet specific application needs. In addition, manipulation commands such as *Difference, *Intersect, and *Union are available for the user to create a desired shape”, Golway et al. paragraph [0069] “Once created, users may run simulations on a model to determine whether or not the constructed output will be structurally sound after printing. After simulations confirm the structural integrity of a printed structure, the user selects the Print command. Once activated, the Print command sends information to the RBW for object fabrication and assembly.”, The examiner considers the running of the simulation to be the processing of the output data, since there a determination of whether or not the constructed output will be structurally sound after printing)];
Dzenis et al., Toly, Zhao et al., Anderson et al. and Golway et al. are analogous art because they are from the same field endeavor of analyzing medical procedures for a patient.
Before the effective filing date of the invention, it would have been obvious to a person of ordinary skill in the art to modify the teachings of Dzenis et al., Toly, Zhao et al. and Anderson et al. of having a computer platform that has a user interface and one or more computational simulation software programs by incorporating wherein said one or more software programs or applications of the computer platform comprise: - one or more user interface management software programs; - one or more computational simulation software programs, configured to perform the computational simulation when executed by a computer; - one or more software processing programs, configured to perform said steps of processing the information on the selection and/or definition and/or setting of a medical device model, processing the information on the selection and/or definition and/or setting of a patient model, processing the selection and/or setting information entered by the user for preparing input setting data for the one or more computational simulation software programs, and processing the output data of the computational simulation to express the desired simulation results as taught by Golway et al. for the purpose of integrating the design and fabrication modalities of a tissue design.
Dzenis et al. in view of Toly in view of Zhao et al. in view of Anderson et al. in further view of Golway et al. teaches wherein said one or more software programs or applications of the computer platform comprise: - one or more user interface management software programs; - one or more computational simulation software programs, configured to perform the computational simulation when executed by a computer; - one or more software processing programs, configured to perform said steps of processing the information on the selection and/or definition and/or setting of a medical device model, processing the information on the selection and/or definition and/or setting of a patient model, processing the selection and/or setting information entered by the user for preparing input setting data for the one or more computational simulation software programs, and processing the output data of the computational simulation to express the desired simulation results.
The motivation for doing so would have been because Golway et al. teaches that by providing a user-friendly tissue structure design and fabrication system, the ability to integrate the design and fabrication modalities of a tissue design can be accomplished, which allows a user to design/model, fabricate and/or analyze complex tissue structures (Golway et al. paragraph [0002], paragraph [0007] – [0008]).

With respect to claim 26, the combination of Dzenis et al., Toly, Zhao et al., Anderson et al. and Golway et al. discloses the method of claim 25 above, and Dzenis et al. further discloses “wherein the method is adapted to perform a computational modeling and simulation of the operation and/or behavior of medical devices which are implantable and/or usable on patients” as [Dzenis et al. (paragraph [0040] “FIG. 1 is a schematic view of a model-based system 10 for analyzing and predicting outcomes of vascular interventions and reconstructions in accordance with an illustrative embodiment.”)];
“and wherein the digital modeling data of medical device are adapted to model the function and/or structure and/or behavior of the medical device which is implantable or usable on a patient, referred to the whole medical device or a part thereof.” as [Dzenis et al. (paragraph [0046] “In some embodiments, the biomechanical model 31 uses coupled solid and fluid mechanics equations as well as data stored within the database 12 in a numerical algorithm that employs finite difference, peridynamic, other meshless, and/or finite element analysis in calculating stresses in blood vessel walls and blood flow parameters within an existing or reconstructed blood vessel. The biomechanical model 31 can also be used to calculate various mechanical and hemodynamic parameters linked to restenosis, such as maximum stress or cyclic stress or strain, wall pressure, wall shear stress, oscillatory shear stress, blood viscosity, and spatial gradients such as wall pressure gradients and wall shear stress gradients.”, Dzenis et al. (paragraph [0047] “The biomechanical model 31 can be used for predicting outputs associated with humans, animals, or both.”)];

With respect to claim 27, the combination of Dzenis et al., Toly, Zhao et al., Anderson et al. and Golway et al. discloses the method of claim 25 above, and Dzenis et al. further discloses “wherein the step of providing a user interface comprises providing a plurality of user- selectable templates, associated with respective types of simulation, and wherein each template comprises: - a plurality of input parameters which can be selected for the simulation, each parameter being associated with a respective range of permitted values, within which a parameter value can be set” as [Dzenis et al. (paragraph [0049] “The mechanical properties evaluation module 34 is configured for use in inputting and evaluating various input parameters 58 relating to the mechanical behavior of biological materials and specimens such as blood vessels and plaque as well as the behavior of natural and synthetic grafts and stents used for treating such vessels. The data inputted to the mechanical properties input module 34 can be classified within the database 46 into appropriate groups, depending on the particular blood vessel under evaluation, the particular treatment method performed (e.g., endarterectomy with a natural graft), as well as other classifications.”, Dzenis et al. paragraph [0053] “The blood vessel geometry input module 38 is configured for use in inputting and evaluating various input parameters 66 related to the geometry of a blood vessel being treated, or for bypass-type procedures involving diseased blood vessels, for evaluating input parameters 66 related to reconstructed vessels. The data inputted to the blood vessel geometry evaluation module 38 can be classified within the database 50 for later analysis by the biomechanical model 31”, Dzenis et al. paragraph [0054] “The medical device geometry input module 40 is configured for use in inputting and evaluating various input parameters 68 related to the geometrical properties (e.g., size, shape, curvature, etc.) of a graft or stent. The data inputted to the module 40 can be classified within the database 52 into appropriate groups for later analysis by the biomechanical model 31.”)];
“- a plurality of selectable output parameters, comprising the desired quantities as an output result” as [Dzenis et al. (paragraph [0045] “The processor 18 is configured to run an algorithm or routine that combines data acquired from one or multiple evaluation modules 32 and generates various output parameters that can be used by the processor 18 and a biomechanical model 31 to analyze, and in some cases predict, various patient-based treatment outcomes associated with the use of a particular reconstruction technique or medical device.”, Dzenis et al. paragraph [0076] “Example analyses and/or optimization operations that can be performed via the output analysis and visualization tools 94 and the optimization control tools 95 comprise computing derivative output parameters on biomechanics data outputs, visualizing anatomical structures for evaluation or comparison (e.g., via mapping color-coded parameters over pulsating blood vessel surface and/or section of a vessel), for performing side-by-side visual comparisons of multiple treatment options under consideration, for computing maxima/minima and/or areas/volumes over a threshold for quantitative comparison of multiple treatment options, for performing automatic or semi-automatic optimizations (e.g., using computational loops and/or non-linear programming methods), and for storing or exporting optimal treatment techniques, materials, devices, and adjustable parameters for further use by surgeons, materials developers, or medical device manufacturers.”)];
“- a plurality of displaying and reporting options, which can be selected by the user to choose the format of the results and/or the methods to analyze the results.” as [Dzenis et al. (paragraph [0103] “An output visualization and analysis tool suite 222 provides a suite of software tools for visualizing and analyzing data. In some embodiments, the output visualization and analysis tool suite 222 provides functionality for visualizing static and dynamic mechanical data (e.g., three-dimensional pulsatile vessel deformations or velocities, blood flow, density/color mapping, stress/strain)”)];

With respect to claim 28, the combination of Dzenis et al., Toly, Zhao et al., Anderson et al. and Golway et al. discloses the method of claim 25 above, and Dzenis et al. further discloses “wherein the selection and/or setting information which can be entered by the user further comprises parameters for the definition and/or specialization of the digital model of the medical device” as [Dzenis et al. [0011] “An illustrative system for analyzing and predicting therapeutic outcomes in medical procedures comprises: a relational database configured for classifying and storing patient specific input data for a plurality of patients;”)];
“and/or wherein the selection and/or setting information which can be entered by the user further comprises parameters for defining and/or customizing the anatomical and/or physiological digital model of one or more real or virtual patients.” as [Dzenis et al. [paragraph [0011] “a processor and fluid-solid interaction biomechanical model configured for performing a biomechanics simulation and generating biomechanics data, the fluid-solid biomechanical model comprising time-dependent, three-dimensional solid and fluid equations; a means for evaluating the outcomes of the biomechanics simulation”)];

With respect to claim 29, the combination of Dzenis et al., Toly, Zhao et al., Anderson et al. and Golway et al. discloses the method of claim 25 above, and Dzenis et al. further discloses “wherein the selection and/or setting information which can be entered by the user further comprises parameters for selecting and/or defining real or virtual patients, or populations of real or virtual patients.” as [Dzenis et al. paragraph [0011] “An illustrative system for analyzing and predicting therapeutic outcomes in medical procedures comprises: a relational database configured for classifying and storing patient specific input data for a plurality of patients; a means for obtaining and inputting patient specific input data to the database; a means for selecting additional data to be associated with the patient in the database”)];

With respect to claim 30, the combination of Dzenis et al., Toly, Zhao et al., Anderson et al. and Golway et al. discloses the method of claim 28 above, and Dzenis et al. further discloses “wherein the selection and/or setting information which can be entered by the user further includes geometric parameters and/or parameters related to the properties of the medical device materials.” as [Dzenis et al. (paragraph [0048] “The suite of evaluation modules 32 can be accessed by the system users 20, 30 to input and evaluate various physiologic parameters relating to current or past patients 22, 24 as well as device-specific parameters relating to those medical devices (e.g., patches, stents, grafts) that are available for treating the patients 22, 24.”, paragraph [0054] “The medical device geometry input module 40 is configured for use in inputting and evaluating various input parameters 68 related to the geometrical properties (e.g., size, shape, curvature, etc.) of a graft or stent.”)];

With respect to claim 31, the combination of Dzenis et al., Toly, Zhao et al., Anderson et al. and Golway et al. discloses the method of claim 25 above, and Dzenis et al. further discloses “wherein the selection and/or setting information which can be entered by the user comprises parameters for setting computational aspects of the simulation, and moreover initial conditions and boundary conditions for the simulation, and/or parameters related to the numerical method used by the computational simulation software” as [Dzenis et al. (paragraph [0046] “Example model inputs that can be used by the biomechanical model 31 to calculate these stresses comprise the material properties of the blood vessel (e.g., linear, non-linear, isotropy, anisotropy, viscoelasticity)”, Dzenis et al. paragraph [0108] “From this information, the system then generates a coupled fluid-solid interaction biomechanical model and instructions (block 238) to be used for analyzing the inputs and model data. The biomechanical model and instructions can be construed in both the fluid and solid domains using an appropriate system of equations for each”, The examiner considers the model inputs that are used by the biomechanical model to calculate the stresses in the blood vessel walls to be the initial conditions and boundary conditions, since the stresses in the blood vessel walls that comprise the material properties of the blood vessel. Also, the examiner considers the instructions used with the biomechanical model generated to be the parameters for setting computational aspects of the simulation, since the instructions and biomechanical model are used in analyzing the inputs and model data)];

With respect to claim 33, the combination of Dzenis et al., Toly, Zhao et al., Anderson et al. and Golway et al. discloses the method of claim 25 above, and Dzenis et al. further discloses “wherein the digital modeling data of a real patient are anonymized and/or de-identified and/or pseudonymized.” as [Dzenis et al. (paragraph [0044] “In contrast, other users 20, 30 such as researchers or medical device developers may be given more limited access credentials to the database 12 in order to maintain patient confidentiality and anonymity.”, Researchers or medical device developers may be given more limited access credentials in order to maintain a patients confidentiality and anonymity. A patient’s information being anonymous, demonstrates that the digital modeling data of a real patient are anonymized)];

With respect to claim 34, the combination of Dzenis et al., Toly, Zhao et al., Anderson et al. and Golway et al. discloses the method of claim 25 above, and Dzenis et al. further discloses “wherein the computational simulation comprises structural and/or fluid-dynamic and/or thermal and/or electromagnetic and/or biomechanical simulations.” as [Dzenis et al. (paragraph [0046] “The biomechanical model 31 can also be used to calculate various mechanical and hemodynamic parameters linked to restenosis, such as maximum stress or cyclic stress or strain, wall pressure, wall shear stress, oscillatory shear stress, blood viscosity, and spatial gradients such as wall pressure gradients and wall shear stress gradients. Example model inputs that can be used by the biomechanical model 31 to calculate these stresses comprise the material properties of the blood vessel (e.g., linear, non-linear, isotropy, anisotropy, viscoelasticity)”, Dzenis et al. [0047] “The biomechanical model 31 can be used for predicting outputs associated with humans, animals, or both.”, By having biomechanical models, demonstrates that there are biomechanical simulations)];

With respect to claim 36, the combination of Dzenis et al., Toly, Zhao et al., Anderson et al. and Golway et al. discloses the method of claim 25 above, and Dzenis et al. further discloses “wherein the computational simulations comprise simulations for the analysis and prediction of the behavior of the medical device on a population of real or virtual patients” as [Dzenis et al. (paragraph [0045] “In certain embodiments, for example, the biomechanical model 31 uses input data obtained across several of the evaluation modules 32 to better understand the current condition of a patient's blood vessel, and from this information, selects a medical device (e.g., a patch or graft/stent) that is optimal for the patient.”)];
“and/or wherein the computational simulations comprise simulations for a customized evaluation of the effects of the medical device on a specific real or virtual patient.” as [Dzenis et al. (paragraph [0038] “The systems and methods can also be used for developing new medical devices, or for developing medical devices customized for use in a particular patient or groups of patients.”, Dzenis et al. paragraph [0045] “In certain embodiments, for example, the biomechanical model 31 uses input data obtained across several of the evaluation modules 32 to better understand the current condition of a patient's blood vessel, and from this information, selects a medical device (e.g., a patch or graft/stent) that is optimal for the patient.”)];

With respect to claim 38, the combination of Dzenis et al., Toly, Zhao et al., Anderson et al. and Golway et al. discloses the method of claim 25 above, and Dzenis et al. further discloses “wherein the medical device is an orthopaedic prosthesis” as [Dzenis et al. (paragraph [0051] “Different types of synthetic and natural grafts, stents, and other implantable devices can be evaluated using the mechanical properties evaluation module 34, including those commonly used for vascular repair, bypass, replacement, and post endarterectomy patching”)];
“the anatomical model of the patient comprises a three-dimensional physiological model” as [Dzenis et al. (paragraph [0102] “In some embodiments, the model assembly tool suite 220 provides functionality for selecting model inputs based on information within the database 212 and/or based on user imported data, for assembling graphical interaction models (e.g., a graphical model for selecting between different repair techniques based on three-dimensional vessel geometry)”)];
“and the simulation comprises structural simulations of the mechanical behavior of the implanted medical device and/or of the biomechanical response of the patient to the implanted device.” as [Dzenis et al. (paragraph [0045] “In the embodiment of FIG. 1, the algorithm or routine comprises a coupled fluid-solid interaction biomechanical model 31 that uses, as model inputs, data that is measured and/or gathered by one or more of the evaluation modules 32. Based on these model inputs, the biomechanical model 31 determines one or more parameters associated with a blood vessel under evaluation or in the selection of a particular medical device for use in treating a patient or group of patients.”, Dzenis et al. paragraph [0046] “Example model inputs that can be used by the biomechanical model 31 to calculate these stresses comprise the material properties of the blood vessel (e.g., linear, non-linear, isotropy, anisotropy, viscoelasticity), the deformation characteristics of the blood vessel (e.g., small versus large deformations), the blood flow characteristics of the blood vessel (e.g., laminar versus turbulent blood flows, Newtonian vs. non-Newtonian rheology)”)];
Anderson et al. discloses “the orthopaedic prosthesis model comprises a three-dimensional structural model” as [Anderson et al. (paragraph [0211] “The system provides a library of 3D representations of medical devices and a library of 3D representations of normal or pathological patient anatomy. In one aspect, the user can select an entry point for insertion of a medical device into a simulated patient (e.g., at either a radial or femoral site) and in response to the user's manipulation, a haptic display will display the navigation of the device through a selected body cavity or lumen”)];

With respect to claim 39, the combination of Dzenis et al., Toly, Zhao et al., Anderson et al. and Golway et al. discloses the method of claim 25 above, and Dzenis et al. further discloses “wherein the medical device is an endovascular device, the model of the endovascular device comprises a fluid-dynamic model, and the simulation comprises a fluid-dynamic simulation of the blood flow.” as [Dzenis et al. (paragraph [0038] “In certain embodiments, the systems and methods can be used in open or endovascular surgery procedures in the treatment of cardiovascular diseases, including coronary artery disease, carotid artery disease and aortoilliac, peripheral, mesenteric, renal, and arm artery stenoses.”, Dzenis et al. paragraph [0046] “In some embodiments, the biomechanical model 31 uses coupled solid and fluid mechanics equations as well as data stored within the database 12 in a numerical algorithm that employs finite difference, peridynamic, other meshless, and/or finite element analysis in calculating stresses in blood vessel walls and blood flow parameters within an existing or reconstructed blood vessel.”, Dzenis et al. paragraph [0097] “The blood pressure input parameter 188 comprises the patient's systolic and diastolic blood pressure during one heart cycle or across multiple heart cycles (e.g., an averaged blood pressure). The force/stress input parameter 190 relates to external forces applied to the vessel, including, but not limited to, forces from surrounding tissue, neighboring grafts and stents, extensions and contractions due to locomotion, and residual stresses.”, The examiner considers the medical device that is developed to be an endovascular device, since the medical device developed can be used for an endovascular surgery procedure. Also, the examiner considers the biomechanical model to be the fluid-dynamic model, since the biomechanical model uses fluid mechanics equations and input into the biomechanical model includes blood flow characteristic of a blood vessel)];

With respect to claim 42, Dzenis et al. discloses “- a digital library in which the following is stored: digital modeling data of a plurality of medical devices which are implantable or usable on a patient, referred to the medical device, or to a part thereof” as [Dzenis et al. (paragraph [0043] “The database 12 is expandable and scalable, allowing for the addition of new data such as tissue histology, tissue models, medical devices, and newly discovered medical record data.”, Fig. 1)];
“a digital library in which the following is stored: anatomical and/or physiological digital modeling data of a plurality of real or virtual patients, referred to one or more anatomical parts of the patient with which the medical devices are intended to interact” as [Dzenis et al. (paragraph [0041] “The database 12 can also be configured to store simultaneous electrocardiogram (ECG) recordings, recordings of blood flow evaluations and other physiologic data acquired from the patients 22, 24”,, Fig. 1, The database can store physiologic data, which demonstrates that physiological data is being stored)];
“- one or more electronic processing components configured to perform, by means of one or more software programs or applications stored and executed therein, the actions of: providing a user interface which can be connected to the Internet and configured to allow a user to connect to and interact with the computer platform of digital data and with one or more software programs included therein” as [Dzenis et al. (paragraph [0070] “In those embodiments in which the system is accessible to multiple users 20, 30 (e.g., as a software program operable over a network server or as a stand-alone software program)”, Dzenis et al. paragraph [0071] “In some embodiments, an interactive graphical user interface (GUI) 90 can be used by the users 20, 30 for analyzing data generated by the biomechanical model 31 and/or the various modules 32. In certain embodiments, for example, the graphical user interface 90 can be used by surgeons and health care professionals for preoperative analysis, evaluation, and visualization of treatment outcomes for individual patients or groups of patients, or for optimizing potential treatment options.”, Dzenis et al. paragraph [0072] “The graphical user interface 90 includes database tools 91 for use in performing various database operations, model assembly tools 92 for use in generating models, simulation control tools 93 for use in performing biomechanics modeling and simulation operations, output analysis and visualization tools 94 for performing analyses on outputs generated by the evaluation unit 14, and optimization control tools 95 for use in optimizing outputs generated by the evaluation unit 14”, Fig. 1 item 90)];
“- receiving selection and/or setting information which can be entered by the user by means of the user interface, wherein the selection and/or setting information comprises: information on the selection and/or definition and/or setting of a medical device model” as [Dzenis et al. ((paragraph [0061] “Example treatment parameters that can be optimized via the module 78 comprise the type of treatment, the type of stent/graft material, the base geometry of the stent/graft, placement location, and attachment location/configuration. In use, the treatment selection/optimization evaluation module 78 employs a mathematical optimization routine using linear or non-linear programming techniques to automatically determine an optimized treatment plan based on the available data stored in the database 12. In some embodiments, the treatment selection/optimization evaluation module 78 continuously varies one or more discretionary variables based on user input preferences. For example, one or more surgeon-defined variables can be used as inputs by the treatment selection/optimization evaluation module 78 to determine an optimized treatment option that takes into account the surgeon's experience and preferences.”, Dzenis et al. [0062] “In some embodiments, the optimization of a particular treatment option can be performed by the treatment selection/optimization evaluation module 78 by visually evaluating the output from a graphical user interface (GUI) 90. Furthermore, and in some embodiments, the treatment selection/optimization evaluation module 78 can also be used to quantitatively compare outputs from several possible treatment options based on appropriate selection criteria.”)];
“information on the selection and/or definition and/or setting of an anatomical and/or physiological model of a patient based on said stored anatomical and/or physiological modeling digital data” as [Dzenis et al. (as [Dzenis et al. (paragraph [0037] “Model-based systems and methods that utilize patient-specific physiological data and/or previously acquired data from other, similarly situated patients or cases can be used to analyze, and in some cases predict, various parameters for determining a suitable course of treatment for a patient. These systems and methods can also be used as a tool for selecting medical devices tailored to a patient's particular medical condition, or for developing new medical devices. In some embodiments, the patient-specific and/or previously acquired input data can be classified and stored in one or more computer databases that can be accessed by individuals over a computer or computer network.”, Dzenis et al. paragraph [0047] “The biomechanical model 31 can be used for predicting outputs associated with humans, animals, or both. In some embodiments, for example, the biomechanical model 31 employs an animal model for evaluating and predicting various outputs related to vascular interventions and reconstructions in animals such as rats, dogs, or pigs. Information acquired from the animal model may provide users 20, 30 with information for researching both the underlying mechanisms of diseases such as atherosclerosis as well as assisting in the development of improved materials, devices, and treatment methods. The biomechanical model 31 can employ semi-destructive, destructive, or non-invasive techniques for evaluating animals, either in vivo or postmortem. Simulated results from the biomechanical model 31 can be compared to data obtained and stored in the database 12.”, Dzenis et al. paragraph [0093] “FIG. 7 is a schematic view showing several example input parameters 68 for use by the medical device geometry evaluation module 38 in analyzing the geometry of a medical device such as a graft or stent. As shown in FIG. 7, the medical device geometry evaluation module 40 receives, as input parameters 68, a graft/stent type input parameter 166 and a graft/stent dimensions input parameter 168. The graft/stent type input parameter 166 relates to the type and/or manufacturer of the device., Fig. 7)];
“information on the selection and setting of a simulation type, and/or information on the selection and setting of one or more input simulation parameters, and of one or more output simulation parameters” as [Dzenis et al. (paragraph [0107] “The system next prompts the user to select treatment and/or medical device data to be associated with a proposed treatment option (block 234). The user then performs a search of the database and obtains model parameters to be associated with the biomechanical model (block 236). If, for example, the user desires to use finite element analysis to analyze the effects of pulsatile blood flow on an endarterectomized blood vessel, the user may select the model type from a display screen, and select from a number of finite element analysis options available for the modeling.”, The examiner considers model parameters to be the input simulation parameters, since the model parameters are associated with the biochemical model)];
“- processing said information on the selection and/or definition and/or setting of a medical device model for preparing a medical device model based on said stored digital data of functional and/or structural modeling and/or of modeling of the behavior of a medical device” as [Dzenis et al. (paragraph [0093] “As shown in FIG. 7, the medical device geometry evaluation module 40 receives, as input parameters 68, a graft/stent type input parameter 166 and a graft/stent dimensions input parameter 168. The graft/stent type input parameter 166 relates to the type and/or manufacturer of the device.”, Dzenis et al. [0094] “Based on the input parameters 64, three-dimensional imaging data/reconstructions and other factors are used by the medical device geometry evaluation module 38 to generate one or more outputs 172 associated with the graft or stent geometry. Examples of outputs 172 that can be evaluated comprise raw data 172a and three-dimensional interpolated data 172b.”)];
“- processing said information on the selection and/or definition and/or setting of a patient model for preparing an anatomical and/or physiological model of one or more anatomical parts of the patient based on said stored digital data of anatomical and/or physiological modeling” as [Dzenis et al. (paragraph [0039] “Although various example systems and methods are described herein with respect to vascular interventions and reconstructions, the systems and methods can be used to analyze and model other types of physiological conditions and can be used to evaluate other treatment options or to develop other types of medical devices.”, Dzenis et al. paragraph [0059] “In some embodiments, the restenosis prediction module 76 comprises a model that links computed mechanical and hemodynamic parameters to atherogenesis. Various physiological and biochemical phenomena accompanying restenosis can also be incorporated into the restenosis prediction module 76. For example, the restenosis prediction module 76 can model mechanotransduction and the effects of mechanical stimuli on migration of endothelial cells (e.g. via the wound-healing model), the effects of stresses and high uniaxial/biaxial strains on SMC signaling, alignment, or apoptosis, various biochemical processes triggered by stress and strain induced gene expressions, as well as other physiological and biochemical phenomena.”)];
“- processing said selection and/or setting information entered by the user for preparing input setting data for one or more computational simulation software programs included in the computer platform” as [Dzenis et al. (paragraph [0093] “FIG. 7 is a schematic view showing several example input parameters 68 for use by the medical device geometry evaluation module 38 in analyzing the geometry of a medical device such as a graft or stent. As shown in FIG. 7, the medical device geometry evaluation module 40 receives, as input parameters 68, a graft/stent type input parameter 166 and a graft/stent dimensions input parameter 168.”, Fig. 7)];
“- processing said selection and/or setting information entered by the user for preparing input setting data for one or more computational simulation software programs included in the computer platform” as [Dzenis et al. (paragraph [0093] “FIG. 7 is a schematic view showing several example input parameters 68 for use by the medical device geometry evaluation module 38 in analyzing the geometry of a medical device such as a graft or stent. As shown in FIG. 7, the medical device geometry evaluation module 40 receives, as input parameters 68, a graft/stent type input parameter 166 and a graft/stent dimensions input parameter 168.”, Fig. 7)];
“- executing the computational simulation, by the one or more computational simulation software programs, on the basis of said input setting data, of said medical device model and of said anatomical and/or physiological model, to obtain output data of the computational simulation” as [Dzenis et al. (paragraph [0093] “One or more other measured or modeled input parameters 170 can also be received for analysis by the medical device geometry evaluation module 38”, Dzenis et al. [0094] “Based on the input parameters 64, three-dimensional imaging data/reconstructions and other factors are used by the medical device geometry evaluation module 38 to generate one or more outputs 172 associated with the graft or stent geometry. Examples of outputs 172 that can be evaluated comprise raw data 172a and three-dimensional interpolated data 172b.”, Fig. 7)];
“- processing the output data of the computational simulation, on the basis of said information on the selection and setting of one or more output simulation parameters, to express simulation results, representative of a functional and/or structural behavior of the medical device and/or patient, in a format selected by the user” as [Dzenis et al. (paragraph [0078] “The graphical user interface 90 can be used to quantitatively and/or qualitatively evaluate certain conditions based on appropriate selected criteria. The selection criteria can be based, for example, on absolute maximum or temporal mean or cyclic values of stress and/or strain intensities in the vessel walls, relative (e.g., percentage) increases in such intensities compared to the vessel before repair or to a healthy vessel, blood flow velocity characteristics (e.g., stagnation points), and wall shear stress. The processor 18 is configured to find critical spots, calculate their extent, and color-code them onto three-dimensional visualization outputs, such as graphs and videos, that can be displayed on the graphical user interface 90 for analysis.”, Dzenis et al. paragraph [0094] “Based on the input parameters 64, three-dimensional imaging data/reconstructions and other factors are used by the medical device geometry evaluation module 38 to generate one or more outputs 172 associated with the graft or stent geometry.”, Fig. 7)];
“- providing the simulation results by means of the user interface.” as [Dzenis et al. (Fig. 1, The results being displayed on the GUI)];
“and wherein the computer platform further comprises a PIDO (Process Integration
and Design Optimization) software program, configured to manage the workflow of the
software programs included in the computer platform and to optimize computational
simulations” as [Dzenis et al. [0061] “The treatment selection/optimization evaluation module
78 is configured for use in evaluating a range of available treatment options and for selecting a
treatment that is best suited for a particular patient. Example treatment parameters that can be
optimized via the module 78 comprise the type of treatment, the type of stent/graft material, the
base geometry of the stent/graft, placement location, and attachment location/configuration. In
use, the treatment selection/optimization evaluation module 78 employs a mathematical
optimization routine using linear or non-linear programming techniques to automatically
determine an optimized treatment plan based on the available data stored in the database 12. In
some embodiments, the treatment selection/optimization evaluation module 78 continuously
varies one or more discretionary variables based on user input preferences.”, The examiner
considers the mathematical optimization routine to be a PIDO (Process Integration and
Design Optimization), since the mathematical optimization routine determines an optimized
treatment plan using linear and non-linear programming by evaluating a range of available
treatment options and selecting a treatment that is best suited for a particular patient.)];
While Dzenis et al. teaches storing digital modeling data of a medical device, Dzenis et al. does not explicitly disclose “A system for functional and/or structural computational modeling and simulation of medical devices which are implantable and/or usable on patients comprising a computer platform”
Toly discloses “A system for functional and/or structural computational modeling and simulation of medical devices which are implantable and/or usable on patients comprising a computer platform” as [Toly (paragraph [0204] “paragraph [0204] “A distal end of simulated tool 496 includes an inductor 498……. Once simulated medical instrument 496 is inserted into esophagus 482 and inductor 498 is energized, the position of the distal end of simulated medical instrument 496 (i.e., the position of inductor 498) can be determined by monitoring the plurality of conductive elastomer-based evaluation circuits 490.”, paragraph [0220] “The present invention can be implemented as a system that collects data using conductive elastomer-based evaluation circuits incorporated in a simulated physiological structure, stores the collected data in a digital format, processes and evaluates the data, and compares the data to related data.”, Fig. 22b item 496, The examiner considers the simulation tool to be the medical device, since the simulation tool is used as a medical device)];
Dzenis et al. and Toly are analogous art because they are from the same field endeavor of analyzing medical procedures for a patient.
Before the effective filing date of the invention, it would have been obvious to a person of ordinary skill in the art to modify the teachings of Dzenis et al. of storing digital modeling data of a medical device by incorporating A system for functional and/or structural computational modeling and simulation of medical devices which are implantable and/or usable on patients comprising a computer platform as taught by Toly for the purpose of simulating a patient’s organ that includes a pressure-sensitive conductive elastomer.
Dzenis et al. in view of Toly teaches a system for functional and/or structural computational modeling and simulation of medical devices which are implantable and/or usable on patients comprising a computer platform.
The motivation for doing so would have been because Toly teaches that by simulating a patient’s organ, the ability to evaluate a trainee’s ability to manipulate the simulated organ can be accomplished, which allows the trainee to see the tactile sensations of the elastomeric materials with which the conductive elastomer is used (Toly (paragraph [0010] – [0011]).
While the combination of Dzenis et al. and Toly teaches a method for functional and/or
structural computational modeling and simulation of medical devices which are implantable
and/or usable on patients, Dzenis et al. and Toly does not explicitly disclose “wherein the
computational simulations comprise simulations for the design and/or development of the
medical device, and simulations for evaluations of the medical device safety and/or compliance
with current regulations; wherein the medical device is implantable and/or usable on
patients”
Zhao et al. discloses “wherein the computational simulations comprise simulations for the design and/or development of the medical device” as [Zhao et al. (paragraph [0052] “In one embodiment, the global FEA modeling is used to simulate the interaction between a lead 114, lead delivery system, and the heart or cardiac veins during implant or explant of a component of a medical implant system.”)];
“and simulations for evaluations of the medical device safety and/or compliance with current regulations” as [Zhao et al. (paragraph [0052] “The global FEA modeling can also be used to evaluate structural performance for developing product design concepts, identifying device implant or explant procedures, and improving quality and reliability of a device to be used in conjunction with the medical implant system”, The examiner considers the improving quality and reliability of a device to be used in conjunction with the medical implant system as being the simulations for compliance with current regulations, since for the quality and reliability of the device to be in conjunction with the medical implant system, it would have to fit a certain criteria that the medical implant system is operating on)];
“wherein the medical device is implantable and/or usable on patients” as [Zhao et al. (paragraph [0030] “FIG. 1A illustrates one embodiment of implementing an implantable medical system to implant an implantable medical device into a human body. A sensor 190 (e.g., leads) placed upon the heart 120 of the human body 105 is used to acquire and process physiological data. An implantable medical unit 195 collects and processes a plurality of data acquired from the human body. In one embodiment, the implantable medical unit 195 may be implemented in a pacemaker 110.”, Fig. 1A)];
Dzenis et al., Toly and Zhao et al. are analogous art because they are from the same field endeavor of analyzing medical procedures for a patient.
Before the effective filing date of the invention, it would have been obvious to a person
of ordinary skill in the art to modify the teachings of Dzenis et al. and Toly of having a method
for functional and/or structural computational modeling and simulation of medical devices which
are implantable and/or usable on patients by incorporating wherein the computational
simulations comprise simulations for the design and/or development of the medical device, and
simulations for evaluations of the medical device safety and/or compliance with current
regulations; wherein the medical device is implantable and/or usable on patients as taught by
Zhao et al. for the purpose of performing an efficient analysis of structures relating to
implantable medical devices.
Dzenis et al. in view of Toly in further view of Zhao et al. teaches wherein the
computational simulations comprise simulations for the design and/or development of the
medical device, and simulations for evaluations of the medical device safety and/or compliance
with current regulations; wherein the medical device is implantable and/or usable on
patients.
The motivation for doing so would have been because Zhao et al. teaches that performing an efficient analysis of structures relating to implantable medical devices, the ability to not delay the delivery of new and innovative products can be accomplished, which allows a physician to receive these innovative products in an efficient time (Zhao et al. (paragraph [0010] – [0012]).
While the combination of Dzenis et al., Toly and Zhao et al. teaches selecting medical devices that are tailored to a patient’s medical condition, where the patient-based treatment outcomes that are associated with a medical device are predicted, Dzenis et al., Toly and Zhao et al. do not explicitly disclose “wherein the one or more electronic processing components are also configured to perform, by means of one or more software programs or applications stored and executed therein, the following further steps: obtaining digital modeling data of a medical device by selecting one or more of a plurality of digital models of medical devices stored in a digital library of the computer platform and/or pre- loaded by the user on the computer platform, wherein said digital models of medical devices include structured digital data sets designed to digitally represent a device, or device parts, or device properties; and obtaining digital modeling data of one or more patients by selecting one or more of a plurality of digital models of real or virtual patients stored in the digital library of the computer platform and/or pre-loaded by the user on the computer platform”
Anderson et al. discloses “wherein the one or more electronic processing components are also configured to perform, by means of one or more software programs or applications stored and executed therein, the following further steps: obtaining digital modeling data of a medical device by selecting one or more of a plurality of digital models of medical devices stored in a digital library of the computer platform and/or pre- loaded by the user on the computer platform” as [Anderson et al. (paragraph [0125] “a device modeling system for modeling a three-dimensional representation of one or more medical devices”, paragraph [0211] “The system provides a library of 3D representations of medical devices and a library of 3D representations of normal or pathological patient anatomy. In one aspect, the user can select an entry point for insertion of a medical device into a simulated patient (e.g., at either a radial or femoral site) and in response to the user's manipulation, a haptic display will display the navigation of the device through a selected body cavity or lumen”)];
“wherein said digital models of medical devices include structured digital data sets designed to digitally represent a device, or device parts, or device properties” as [Anderson et al. (paragraph [0125] “a device modeling system for modeling a three-dimensional representation of one or more medical devices”, paragraph [0211] “The system provides a library of 3D representations of medical devices and a library of 3D representations of normal or pathological patient anatomy. In one aspect, the user can select an entry point for insertion of a medical device into a simulated patient (e.g., at either a radial or femoral site) and in response to the user's manipulation, a haptic display will display the navigation of the device through a selected body cavity or lumen”)];
“and obtaining digital modeling data of one or more patients by selecting one or more of a plurality of digital models of real or virtual patients stored in the digital library of the computer platform and/or pre-loaded by the user on the computer platform” as [Anderson et al. (paragraph [0125] “In a preferred aspect, the system comprises a geometric modeling system for modeling a three-dimensional representation of a body lumen or cavity”, paragraph [0211] “The system provides a library of 3D representations of medical devices and a library of 3D representations of normal or pathological patient anatomy. In one aspect, the user can select an entry point for insertion of a medical device into a simulated patient (e.g., at either a radial or femoral site) and in response to the user's manipulation, a haptic display will display the navigation of the device through a selected body cavity or lumen”)];
Dzenis et al., Toly, Zhao et al. and Anderson et al. are analogous art because they are from the same field endeavor of analyzing medical procedures for a patient.
Before the effective filing date of the invention, it would have been obvious to a person of ordinary skill in the art to modify the teachings of Dzenis et al., Toly and Zhao et al. of selecting medical devices that are tailored to a patient’s medical condition, where the patient-based treatment outcomes that are associated with a medical device are predicted by incorporating wherein the one or more electronic processing components are also configured to perform, by means of one or more software programs or applications stored and executed therein, the following further steps: obtaining digital modeling data of a medical device by selecting one or more of a plurality of digital models of medical devices stored in a digital library of the computer platform and/or pre- loaded by the user on the computer platform, wherein said digital models of medical devices include structured digital data sets designed to digitally represent a device, or device parts, or device properties; and obtaining digital modeling data of one or more patients by selecting one or more of a plurality of digital models of real or virtual patients stored in the digital library of the computer platform and/or pre-loaded by the user on the computer platform as taught by Anderson et al. for the purpose of simulating image-guided medical procedures.
Dzenis et al. in view of Toly in further view of Zhao et al. in further view of Anderson et al. teaches wherein the one or more electronic processing components are also configured to perform, by means of one or more software programs or applications stored and executed therein, the following further steps: obtaining digital modeling data of a medical device by selecting one or more of a plurality of digital models of medical devices stored in a digital library of the computer platform and/or pre- loaded by the user on the computer platform, wherein said digital models of medical devices include structured digital data sets designed to digitally represent a device, or device parts, or device properties; and obtaining digital modeling data of one or more patients by selecting one or more of a plurality of digital models of real or virtual patients stored in the digital library of the computer platform and/or pre-loaded by the user on the computer platform.
The motivation for doing so would have been because Anderson et al. teaches that having a realistic simulation environment for training and pretreatment planning of image-guided medical procedures, the ability to have physicians properly navigate, orient or position catheters and/or other medical devices within a patient can be accomplish, which allows physicians to properly recognize an anatomic area or pathology that is to be treated (Anderson et al. (paragraph [0004], paragraph [0011])).
While the combination of Dzenis et al., Toly, Zhao et al. and Anderson et al. teaches having a computer platform that has a user interface and one or more computational simulation software programs, Dzenis et al., Toly, Zhao et al. and Anderson et al. do not explicitly disclose “wherein said one or more software programs or applications of the computer platform comprise: - one or more user interface management software programs; - one or more computational simulation software programs, configured to perform the computational simulation when executed by a computer; - one or more software processing programs, configured to perform said steps of processing the information on the selection and/or definition and/or setting of a medical device model, processing the information on the selection and/or definition and/or setting of a patient model, processing the selection and/or setting information entered by the user for preparing input setting data for the one or more computational simulation software programs, and processing the output data of the computational simulation to express the desired simulation results; and wherein the computer platform further comprises a PIDO (Process Integration and Design Optimization) software program, configured to manage the workflow of the software programs included in the computer platform and to optimize computational simulations.”
Golway et al. discloses “wherein said one or more software programs or applications of the computer platform comprise: - one or more user interface management software programs” as [Golway et al. (paragraph [0009] “The tissue modeling component comprises a user interface, at least one suite of tools for performing an object operation selected from the operation categories of creating, editing, modeling, transforming, image property modulating, sketching, print supporting, simulating, material testing and combinations thereof, a material database, and software executable by a machine to facilitate a method for designing a volumetric model of a biological construct at the user interface.”, Golway et al. paragraph [0041] “Generally, TSIM comprises software and a user interface comprising an object modeling environment. TSIM comprises several suites of tools for performing one or more object operations. Object modeling tools include but are not limited to tool suites for creating, editing, modeling, transforming, image property modulating, sketching, print supporting, simulating, material testing and combinations thereof.”)];
“- one or more computational simulation software programs, configured to perform the computational simulation when executed by a computer” as [Golway et al. (paragraph [0041] “Generally, TSIM comprises software and a user interface comprising an object modeling environment. TSIM comprises several suites of tools for performing one or more object operations.”)];
“- one or more software processing programs, configured to perform said steps of processing the information on the selection and/or definition and/or setting of a medical device model” as [Golway et al. (paragraph [0051] “Data generated from medical imaging technology is imported to TSIM, analyzed, and used to generate 3-D models or model scaffolds and/or tissue constructs customized to be patient-specific. In certain embodiments, tissues, organs, medical devices and medical jigs may be modeled and fabricated clinically in situ based on specific needs of a patient.”)];
“processing the information on the selection and/or definition and/or setting of a patient model” as [Golway et al. (paragraph [0051] “Data generated from medical imaging technology is imported to TSIM, analyzed, and used to generate 3-D models or model scaffolds and/or tissue constructs customized to be patient-specific. In certain embodiments, tissues, organs, medical devices and medical jigs may be modeled and fabricated clinically in situ based on specific needs of a patient.”, The generating the 3D models that are customized to a specific patient, demonstrates that there the information on the selection and/or definition and/or setting is processed)];
“processing the selection and/or setting information entered by the user for preparing input setting data for the one or more computational simulation software programs” as [Golway et al. (paragraph [0068] “According to a second workflow, users create models using basic shapes. In one aspect of the second workflow, a basic set of geometric shapes is available to users (e.g., cube, cylinder, sphere, pyramid), all of which can be selected and placed directly into the object modeling environment and combined, stretched and deformed to meet specific application needs. In addition, manipulation commands such as *Difference, *Intersect, and *Union are available for the user to create a desired shape”)]
“and processing the output data of the computational simulation to express the desired simulation results” as [Golway et al. (paragraph [0068] “According to a second workflow, users create models using basic shapes. In one aspect of the second workflow, a basic set of geometric shapes is available to users (e.g., cube, cylinder, sphere, pyramid), all of which can be selected and placed directly into the object modeling environment and combined, stretched and deformed to meet specific application needs. In addition, manipulation commands such as *Difference, *Intersect, and *Union are available for the user to create a desired shape”, Golway et al. paragraph [0069] “Once created, users may run simulations on a model to determine whether or not the constructed output will be structurally sound after printing. After simulations confirm the structural integrity of a printed structure, the user selects the Print command. Once activated, the Print command sends information to the RBW for object fabrication and assembly.”, The examiner considers the running of the simulation to be the processing of the output data, since there a determination of whether or not the constructed output will be structurally sound after printing)];
Dzenis et al., Toly, Zhao et al., Anderson et al. and Golway et al. are analogous art because they are from the same field endeavor of analyzing medical procedures for a patient.
Before the effective filing date of the invention, it would have been obvious to a person of ordinary skill in the art to modify the teachings of Dzenis et al., Toly, Zhao et al. and Anderson et al. of having a computer platform that has a user interface and one or more computational simulation software programs by incorporating wherein said one or more software programs or applications of the computer platform comprise: - one or more user interface management software programs; - one or more computational simulation software programs, configured to perform the computational simulation when executed by a computer; - one or more software processing programs, configured to perform said steps of processing the information on the selection and/or definition and/or setting of a medical device model, processing the information on the selection and/or definition and/or setting of a patient model, processing the selection and/or setting information entered by the user for preparing input setting data for the one or more computational simulation software programs, and processing the output data of the computational simulation to express the desired simulation results as taught by Golway et al. for the purpose of integrating the design and fabrication modalities of a tissue design.
Dzenis et al. in view of Toly in view of Zhao et al. in view of Anderson et al. in further view of Golway et al. teaches wherein said one or more software programs or applications of the computer platform comprise: - one or more user interface management software programs; - one or more computational simulation software programs, configured to perform the computational simulation when executed by a computer; - one or more software processing programs, configured to perform said steps of processing the information on the selection and/or definition and/or setting of a medical device model, processing the information on the selection and/or definition and/or setting of a patient model, processing the selection and/or setting information entered by the user for preparing input setting data for the one or more computational simulation software programs, and processing the output data of the computational simulation to express the desired simulation results.
The motivation for doing so would have been because Golway et al. teaches that by providing a user-friendly tissue structure design and fabrication system, the ability to integrate the design and fabrication modalities of a tissue design can be accomplished, which allows a user to design/model, fabricate and/or analyze complex tissue structures (Golway et al. paragraph [0002], paragraph [0007] – [0008]).

16. Claim 40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dzenis et al. in view of Toly in further view of Zhao et al. in further view of Anderson et al. in further view of Golway et al. in further view of online reference Detailing Rafio Frequency Heating Induced by Coronary Stents: A 7.0 tesla Magnetic Resonance Study, written by Santoro et al. (from IDS dated 11/20/20).

With respect to claim 40, the combination of Dzenis et al., Toly, Zhao et al., Anderson et al. and Golway et al. discloses the method of claim 25 above, and Dzenis et al. further discloses “wherein the medical device is a device which can be implanted in the patient’s body” as [Dzenis et al. (paragraph [0045] “Based on these model inputs, the biomechanical model 31 determines one or more parameters associated with a blood vessel under evaluation or in the selection of a particular medical device for use in treating a patient or group of patients.”, Dzenis et al. paragraph [0049] “The data inputted to the mechanical properties input module 34 can be classified within the database 46 into appropriate groups, depending on the particular blood vessel under evaluation, the particular treatment method performed (e.g., endarterectomy with a natural graft), as well as other classifications”, The examiner considers the stent to be the medical device, since the stent can be implanted in a patient’s body)];
While the combination of Dzenis et al., Toly, Zhao et al., Anderson et al. and Golway et al. teaches analyzing the behavior of a medical device which is a stent, that is implanted on a patient’s body, Dzenis et al., Toly, Zhao et al., Anderson et al. and Golway et al.do not explicitly disclose “the model of the implantable device comprises a behavioral and/or thermal model under electromagnetic field effect, and the simulation comprises an electromagnetic simulation adapted to simulate the effect of the electromagnetic field on the temperature variation of the patient’s tissues and/or on the behavior of the device”
Santoro et al. discloses “the model of the implantable device comprises a behavioral and/or thermal model under electromagnetic field effect” as [Santoro et al. (Pg. 1, right col., last paragraph, “Realizing the limits of the International Commission on Non-Ionizing Radiation Protection (ICNIRP), ETC.”, Pg. 3, left col., Numerical EMF Simulations, 1st – 3rd paragraph, “Numerical EMF simulations were conducted, etc.”)];
“and the simulation comprises an electromagnetic simulation adapted to simulate the effect of the electromagnetic field on the temperature variation of the patient’s tissues and/or on the behavior of the device.” as [Santoro et al. (Pg. 1, right col., last paragraph, “Realizing the limits of the International Commission on Non-Ionizing Radiation Protection (ICNIRP), ETC.”, Pg. 3, left col., Numerical EMF Simulations, 1st – 3rd paragraph, “Numerical EMF simulations were conducted, etc.”))];
Dzenis et al., Toly, Zhao et al., Anderson et al., Golway et al.and Santoro et al. are analogous art because they are from the same field endeavor of analyzing medical procedures for a patient.
Before the effective filing date of the invention, it would have been obvious to a person of ordinary skill in the art to modify the teachings of Dzenis et al., Toly, Zhao et al., Anderson et al. and Golway et al. of analyzing the behavior of a medical device which is a stent, that is implanted on a patient’s body by incorporating the model of the implantable device comprises a behavioral and/or thermal model under electromagnetic field effect, and the simulation comprises an electromagnetic simulation adapted to simulate the effect of the electromagnetic field on the temperature variation of the patient’s tissues and/or on the behavior of the device as taught by Santoro et al. for the purpose of examining radiofrequency (RF) heating effects of stents using electro-magnetic field (EMF) simulations and phantoms with properties that mimic myocardium.
Dzenis et al. in view of Toly in view of Zhao et al. in further view of Anderson et al. in further view of Golway et al. in further view of Santoro et al. teaches the model of the implantable device comprises a behavioral and/or thermal model under electromagnetic field effect, and the simulation comprises an electromagnetic simulation adapted to simulate the effect of the electromagnetic field on the temperature variation of the patient’s tissues and/or on the behavior of the device.
The motivation for doing so would have been because Santoro et al. teaches that by examining radiofrequency (RF) heating effects of stents using electro-magnetic field (EMF) simulations and phantoms with properties that mimic myocardium, the ability to not induce local heating can be accomplished, where tissue damage will not occur (Santoro et al. (Abstract, Pg. 10, Conclusions, “Our results show agreement between EMF, etc.”).

17. Claim 41 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dzenis et al. in view of Toly in further view of Zhao et al. in further view of Anderson et al. in further view of Golway et al. in further view of online reference A general model of coupled drug release ad tissue absorption for drug delivery devices, written by McGinty et al. (from IDS dated 11/20/20) in further view of online reference Detailing Radio Frequency Heating Induced by Coronary Stents: A 7.0 tesla Magnetic Resonance Study, written by Santoro et al. (from IDS dated 11/20/20)

With respect to claim 41, the combination of Dzenis et al., Toly, Zhao et al., Anderson et al. and Golway et al. discloses the method of claim 25 above, and Dzenis et al. further discloses “and the simulation comprises fluid-dynamic and/or functional simulations” as [Dzenis et al. (paragraph [0093] “One or more other measured or modeled input parameters 170 can also be received for analysis by the medical device geometry evaluation module 38”, Dzenis et al. paragraph [0094] “Based on the input parameters 64, three-dimensional imaging data/reconstructions and other factors are used by the medical device geometry evaluation module 38 to generate one or more outputs 172 associated with the graft or stent geometry.”, Fig. 7)];
While the combination of Dzenis et al., Toly, Zhao et al., Anderson et al. and Golway et al. teaches analyzing the behavior of a medical device that can be implanted in a patient’s body, Dzenis et al., Toly, Zhao et al., Anderson et al. and Golway et al. do not explicitly disclose “wherein the medical device is an implantable drug-releasing device, the model of the implantable device comprises a fluid-dynamic model”
McGinity et al. discloses “wherein the medical device is an implantable drug-releasing device, the model of the implantable device comprises a fluid-dynamic model” as [McGinity (Pg. 328, sec. 2 The general drug delivery device, 1st paragraph, “In its basic formulation, a DDD consists, etc.”, Pg. 328, sec. 3 Modelling drug release from the polymer matrix, 1st – 2nd paragraph, “We consider coatings that contains, etc.”)];
Dzenis et al., Toly, Zhao et al., Anderson et al., Golway et al. and McGinity et al. are analogous art because they are from the same field endeavor of analyzing medical procedures for a patient.
Before the effective filing date of the invention, it would have been obvious to a person of ordinary skill in the art to modify the teachings of Dzenis et al., Toly, Zhao et al., Anderson et al. and Golway et al. of analyzing the behavior of a medical device that can be implanted in a patient’s body by incorporating wherein the medical device is an implantable drug-releasing device, the model of the implantable device comprises a fluid-dynamic model as taught by McGinity et al. for the purpose of analyzing the drug release from a drug delivery device (DDD).
Dzenis et al. in view of Toly in view of Zhao et al. in further view of Anderson et al. in further view of Golway et al. in further view of McGinity et al. teaches wherein the medical device is an implantable drug-releasing device, the model of the implantable device comprises a fluid-dynamic model.
The motivation for doing so would have been because McGinity et al. teaches that by analyzing the drug release from a drug delivery device, the ability to better understand the drug release kinetics of an existing DDD can be accomplished, which allows for better designs of a drug release model (McGinity et al. (Pg. 335, sec. Conclusions, 1st – 2nd paragraph, “Besides being a relevant bioengineering application, etc.”).
While the combination of Dzenis et al., Toly, Zhao et al., Anderson et al., Golway et al. and McGinity et al. teaches a medical device being an implantable drug-releasing device, Dzenis et al., Toly, Zhao et al., Anderson et al., Golway et al. and McGinity et al. do not explicitly disclose “the anatomical and/or physiological model comprises a parameter related to permeability”
Santoro et al. discloses “the anatomical and/or physiological model comprises a parameter related to permeability” as [Santoro et al. (Pg. 4, left col., 2nd – 3rd paragraph, “EMF and specific absorption rate (SAR), etc.”)];
Dzenis et al., Toly, Zhao et al., Anderson et al., Golway et al., McGinity et al. and Santoro et al. are analogous art because they are from the same field endeavor of analyzing medical procedures for a patient.
Before the effective filing date of the invention, it would have been obvious to a person of ordinary skill in the art to modify the teachings of Dzenis et al., Toly, Zhao et al., Anderson et al., Golway et al. and McGinity et al. of having a medical device being an implantable drug-releasing device by incorporating the anatomical and/or physiological model comprises a parameter related to permeability as taught by Santoro et al. for the purpose of examining radiofrequency (RF) heating effects of stents using electro-magnetic field (EMF) simulations and phantoms with properties that mimic myocardium.
Dzenis et al. in view of Toly in view of Zhao et al. in view of Anderson et al. in further view of Golway et al. in view of McGinity et al. in further view of Santoro et al. teaches the anatomical and/or physiological model comprises a parameter related to permeability.
The motivation for doing so would have been because Santoro et al. teaches that by examining radiofrequency (RF) heating effects of stents using electro-magnetic field (EMF) simulations and phantoms with properties that mimic myocardium, the ability to not induce local heating can be accomplished, where tissue damage will not occur (Santoro et al. (Abstract, Pg. 10, Conclusions, “Our results show agreement between EMF, etc.”).

18. Claim 45-46 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dzenis et al. in view of Toly in further view of Zhao et al. in further view of Anderson et al. in further view of Golway et al. in further view of Miles et al. (U.S. PGPub 2015/0193590).

With respect to claim 45, the combination of Dzenis et al., Toly, Zhao et al., Anderson et al. and Golway et al. discloses the method of claim 25 above.
While the combination of Dzenis et al., Toly, Zhao et al., Anderson et al. and Golway et al. teaches storing anatomical and/or physiological digital modelling data of a real or virtual patient, Dzenis et al., Toly, Zhao et al., Anderson et al. and Golway et al. do not explicitly disclose “wherein said anatomical and/or physiological digital modelling data of a real or virtual patient is of a real patient, and further comprising implanting and/or using the medical device on said real patient”
Miles et al. discloses “wherein said anatomical and/or physiological digital modelling data of a real or virtual patient is of a real patient, and further comprising implanting the medical device in said real patient and/or operating on said real patient” as [Miles et al. (paragraph [0702] “Data 16 is indicative of the static characteristics of the joint and includes one or more stationary measurements taken of the joint and/or of its alignment relative to other physiological components specific to the patient”, Miles et al. paragraph [0745] “In this sense, the orthopaedic implant and the custom articulation, once attached, adhered, or mechanically locked to the corresponding implant (for example, a tibial tray), can be fitted to the joint of the patient to enable the patient to perform the desired post-implant activities according to their desired preference”)];
Dzenis et al., Toly, Zhao et al., Anderson et al., Golway et al. and Miles et al. are analogous art because they are from the same field endeavor of analyzing medical procedures for a patient.
Before the effective filing date of the invention, it would have been obvious to a person of ordinary skill in the art to modify the teachings of Dzenis et al., Toly, Zhao et al., Anderson et al. and Golway et al. of storing anatomical and/or physiological digital modelling data of a real or virtual patient by incorporating wherein said anatomical and/or physiological digital modelling data of a real or virtual patient is of a real patient, and further comprising implanting and/or using the medical device on said real patient as taught by Miles et al. for the purpose of providing alignment information data that includes 3D model data of a patient’s joint for the alignment of an orthopaedic implant for a patient.
Dzenis et al. in view of Toly in view of Zhao et al. in further view of Anderson et al. in view of Golway et al. in further view of Miles et al. teaches wherein said anatomical and/or physiological digital modelling data of a real or virtual patient is of a real patient, and further comprising implanting and/or using the medical device on said real patient.
The motivation for doing so would have been because Miles et al. teaches providing 3D model data of a patient’s joint for the alignment of an orthopaedic implant for a patient, the ability to have an accurate alignment of the orthopaedic implant to fit the patient can be accomplished, so that the patient can function as normally as possible (Anderson et al. (paragraph [0009], paragraph [0023], paragraph [0028])).

With respect to claim 46, the combination of Dzenis et al., Toly, Zhao et al., Anderson et al. and Golway et al. discloses the method of claim 38 above.
While the combination of Dzenis et al., Toly, Zhao et al., Anderson et al. and Golway et al. teaches having a medical device that’s an orthopaedic prosthesis, Dzenis et al., Toly, Zhao et al., Anderson et al. and Golway et al. do not explicitly disclose “fitting the patient with the orthopaedic prosthesis”
Miles et al. discloses “fitting the patient with the orthopaedic prosthesis” as [Miles et al. (paragraph [0745] “In this sense, the orthopaedic implant and the custom articulation, once attached, adhered, or mechanically locked to the corresponding implant (for example, a tibial tray), can be fitted to the joint of the patient to enable the patient to perform the desired post-implant activities according to their desired preference”)];
Dzenis et al., Toly, Zhao et al., Anderson et al., Golway et al. and Miles et al. are analogous art because they are from the same field endeavor of analyzing medical procedures for a patient.
Before the effective filing date of the invention, it would have been obvious to a person of ordinary skill in the art to modify the teachings of Dzenis et al., Toly, Zhao et al., Anderson et al. and Golway et al. of having a medical device that’s an orthopaedic prosthesis by incorporating fitting the patient with the orthopaedic prosthesis as taught by Miles et al. for the purpose of providing alignment information data that includes 3D model data of a patient’s joint for the alignment of an orthopaedic implant for a patient.
Dzenis et al. in view of Toly in view of Zhao et al. in further view of Anderson et al. in view of Golway et al. in further view of Miles et al. teaches fitting the patient with the orthopaedic prosthesis.
The motivation for doing so would have been because Miles et al. teaches providing 3D model data of a patient’s joint for the alignment of an orthopaedic implant for a patient, the ability to have an accurate alignment of the orthopaedic implant to fit the patient can be accomplished, so that the patient can function as normally as possible (Anderson et al. (paragraph [0009], paragraph [0023], paragraph [0028])).

19. Claim 47 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dzenis et al. in view of Toly in further view of Zhao et al. in further view of Anderson et al. in further view of Golway et al. in further view of Santoro et al. in view of Miles et al. (U.S. PGPub 2015/0193590).

With respect to claim 47, the combination Dzenis et al., Toly, Zhao et al., Anderson et al., Golway et al. and Santoro et al. discloses the method of claim 40 above.
While the combination of Dzenis et al., Toly, Zhao et al., Anderson et al., Golway et al. and Santoro et al. teaches the model of the implantable device comprises a behavioral and/or thermal model under electromagnetic field effect, Dzenis et al., Toly, Zhao et al., Anderson et al., Golway et al. and Santoro et al. do not explicitly disclose “implanting the device in the patient’s body”
Miles et al. discloses “implanting the device in the patient’s body” as [Miles et al. (paragraph [0745] “In this sense, the orthopaedic implant and the custom articulation, once attached, adhered, or mechanically locked to the corresponding implant (for example, a tibial tray), can be fitted to the joint of the patient to enable the patient to perform the desired post-implant activities according to their desired preference”)];
Dzenis et al., Toly, Zhao et al., Anderson et al., Golway et al. Santoro et al. and Miles et al. are analogous art because they are from the same field endeavor of analyzing medical procedures for a patient.
Before the effective filing date of the invention, it would have been obvious to a person of ordinary skill in the art to modify the teachings of Dzenis et al., Toly, Zhao et al., Anderson et al., Golway et al. and Santoro et al. of the model of the implantable device comprises a behavioral and/or thermal model under electromagnetic field effect by incorporating implanting the device in the patient’s body as taught by Miles et al. for the purpose of providing alignment information data that includes 3D model data of a patient’s joint for the alignment of an orthopaedic implant for a patient.
Dzenis et al. in view of Toly in view of Zhao et al. in further view of Anderson et al. in further view of Golway et al. in further view of Santoro et al. in further view of Miles et al. teaches implanting the device in the patient’s body.
The motivation for doing so would have been because Miles et al. teaches providing 3D model data of a patient’s joint for the alignment of an orthopaedic implant for a patient, the ability to have an accurate alignment of the orthopaedic implant to fit the patient can be accomplished, so that the patient can function as normally as possible (Anderson et al. (paragraph [0009], paragraph [0023], paragraph [0028])).

Conclusion
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.
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/BERNARD E COTHRAN/Examiner, Art Unit 2188
/RYAN F PITARO/Supervisory Patent Examiner, Art Unit 2188

Prosecution Timeline

• Sep 28, 2020: Application Filed
• Feb 24, 2022: Non-Final Rejection — §101, §103
• Jul 05, 2022: Response Filed
• Oct 19, 2022: Final Rejection — §101, §103
• Apr 26, 2023: Request for Continued Examination
• Apr 27, 2023: Response after Non-Final Action
• Jul 13, 2023: Non-Final Rejection — §101, §103
• Jan 17, 2024: Response Filed
• Apr 25, 2024: Final Rejection — §101, §103
• Oct 29, 2024: Request for Continued Examination
• Oct 30, 2024: Response after Non-Final Action
• Jan 11, 2025: Non-Final Rejection — §101, §103
• Jul 21, 2025: Response Filed
• Oct 24, 2025: Final Rejection — §101, §103 (current)