DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Rejection Under 101
Applicant's arguments filed 12/12/2025 have been fully considered.
Applicant argues that the claims are amended to comprise language that was previously in claim 15 that was not specifically addressed in the office action.
In response to Applicant’s argument, the exemplary claim shown was claim 1, the limitation at issue was substantially similar to that of claim 5, which was addressed in the previous office action. See the updated rejection below for further clarification.
Applicant refers Examiner to Example 39 and argues that the claims recite a neural network and the neural network trained based on training data. The apparatus addresses the issue of appropriately evaluating risk of adverse events that may occur in a patient (Spec. pg. 16-17). It is not practical to perform in the mind, inputting treatment conditions into the neural network and estimating adverse events.
In response to Applicant’s argument, the neural network and training the neural network are considered additional elements and not part of the abstract idea. Rather these are considered tools to carry out the abstract idea in a computer environment. See the updated rejection below for further clarification.
Applicant argues that independent claims 12 and 13 also recite the neural network and training the neural network and thus cannot be a mental process.
In response to Applicant’s argument, the neural network and training the neural network are considered additional elements and not part of the abstract idea. Rather these are considered tools to carry out the abstract idea in a computer environment. See the updated rejection below for further clarification.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 6-14 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., an abstract idea) without significantly more.
Step 1 of the Alice/Mayo Test
Claims 1, 6-11, 14 are drawn to a medical information processing system, which is within the four statutory categories (i.e. apparatus). Claims 12 are drawn to a medical information processing method, which is within the four statutory categories (i.e. process). Claims 13 are drawn to a computer-readable non-transitory storage medium, which is within the four statutory categories (i.e. manufacture).
Step 2A of the Alice/Mayo Test - Prong One
The independent claims recite an abstract idea. For example claim 1 (and substantially similar with independent claim 12, 13) recites:
A medical information processing system comprising:
a radiation treatment planning system; and
a medical information processing apparatus comprising:
a communication interface configured to communicate with the radiation treatment planning system; and
processing circuitry configured to:
acquire treatment conditions to be applied to the treatment target from the radiation treatment planning system;
estimate a prognosis of a treatment target on the basis of the acquired treatment conditions; and
output the estimated prognosis of the treatment target via an output interface or transmit the estimated prognosis of the treatment target to the radiation treatment planning system via the communication interface,
wherein the processing circuitry estimates adverse events that are able to occur in the treatment target as the prognosis of the treatment target on the basis of reference information in which adverse events that are able to occur when each reference treatment condition is applied are associated with each of a plurality of reference treatment conditions, and the treatment conditions to be applied to the treatment target,
wherein, in the reference information, some or all of timings of occurrence of the adverse events, frequencies of occurrence of the adverse events, and severities of symptoms of the adverse events are further associated with the reference treatment conditions,
wherein, in the reference information, the timings, the frequencies, or the severities of the symptoms are further determined for each radiation tolerance criterion of the reference treatment conditions,
wherein the processing circuitry estimates some or all of the timings, frequencies, and symptom severities of the adverse events that are able to occur in the treatment target according to radiation tolerance criteria of the treatment conditions to be applied to the treatment target,
wherein the processing circuitry inputs the treatment conditions into a neural network and estimates adverse events that are able to occur in the treatment target output by the neural network in response to the input of the treatment conditions, as the prognosis of the treatment target, and
wherein the neural network is trained based on a training data set that includes a data set with the adverse events that are able to occur when each reference treatment condition is applied are associated with each of the plurality of reference treatment conditions.
These underlined elements recite an abstract idea that can be categorized, under its broadest reasonable interpretation, to cover performance of the limitation in the mind but for the recitation of generic computer components. That is, other that reciting by the medical information processing apparatus, processing circuitry, communication interface, output interface, computer, computer-readable non-transitory storage medium storing a program for being executed by a computer, radiation treatment planning system, neural network, neural network trained on training data, nothing in the claim element precludes the step from practically being performed by the mind. For example, but for the generic computer components the limitations in the context of this claim encompass a mental process of determining a prognosis for treating a condition, which is something a physician does on a daily basis when treating a patient. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. See MPEP § 2106.04(a)(II).
Dependent claims recite additional subject matter which further narrows or defines the abstract idea embodied in the claims (such as claims 6-11, 14 reciting particular aspects of the abstract idea).
Step 2A of the Alice/Mayo Test - Prong Two
For example independent claim 1 (and substantially similar with independent claim 12, 13) recites:
A medical information processing system comprising: (merely invokes use of computer and other machinery as a tool as noted below, see MPEP 2106.05(f))
a radiation treatment planning system; and (merely invokes use of computer and other machinery as a tool as noted below, see MPEP 2106.05(f))
a medical information processing apparatus comprising: (merely invokes use of computer and other machinery as a tool as noted below, see MPEP 2106.05(f))
a communication interface configured to communicate with the radiation treatment planning system; and (merely invokes use of computer and other machinery as a tool as noted below, see MPEP 2106.05(f))
processing circuitry configured to: (merely invokes use of computer and other machinery as a tool as noted below, see MPEP 2106.05(f))
acquire treatment conditions to be applied to the treatment target from the radiation treatment planning system;
estimate a prognosis of a treatment target on the basis of the acquired treatment conditions; and
output the estimated prognosis of the treatment target via an output interface or transmit the estimated prognosis of the treatment target to the radiation treatment planning system via the communication interface, (merely insignificant extrasolution activity steps as noted below, see MPEP 2106.05(g))
wherein the processing circuitry (merely invokes use of computer and other machinery as a tool as noted below, see MPEP 2106.05(f)) estimates adverse events that are able to occur in the treatment target as the prognosis of the treatment target on the basis of reference information in which adverse events that are able to occur when each reference treatment condition is applied are associated with each of a plurality of reference treatment conditions, and the treatment conditions to be applied to the treatment target,
wherein, in the reference information, some or all of timings of occurrence of the adverse events, frequencies of occurrence of the adverse events, and severities of symptoms of the adverse events are further associated with the reference treatment conditions,
wherein, in the reference information, the timings, the frequencies, or the severities of the symptoms are further determined for each radiation tolerance criterion of the reference treatment conditions,
wherein the processing circuitry (merely invokes use of computer and other machinery as a tool as noted below, see MPEP 2106.05(f)) estimates some or all of the timings, frequencies, and symptom severities of the adverse events that are able to occur in the treatment target according to radiation tolerance criteria of the treatment conditions to be applied to the treatment target,
wherein the processing circuitry inputs the treatment conditions into a neural network (merely invokes use of computer and other machinery as a tool as noted below, see MPEP 2106.05(f))and estimates adverse events that are able to occur in the treatment target output by the neural network in response to the input of the treatment conditions, as the prognosis of the treatment target, and
wherein the neural network is trained based on a training data set (merely invokes use of computer and other machinery as a tool as noted below, see MPEP 2106.05(f)) that includes a data set with the adverse events that are able to occur when each reference treatment condition is applied are associated with each of the plurality of reference treatment conditions.
The judicial exception is not integrated into a practical application. In particular, the additional elements do not integrate the abstract idea into a practical application, other than the abstract idea per se, because the additional elements amount to no more than limitations, which:
amount to mere instructions to apply an exception (such as recitations of the medical information processing apparatus, processing circuitry, communication interface, output interface, computer, computer-readable non-transitory storage medium storing a program for being executed by a computer, radiation treatment planning system, neural network, neural network trained on training data, thereby invoking computers as a tool to perform the abstract idea, see applicant’s specification [0019]-[0024], [0030]-[0031], [0065]-[0070] see MPEP 2106.05(f))
add insignificant extra-solution activity to the abstract idea (such as recitation of outputting the prognosis via the output interface amounts to insignificant extrasolution activity, see MPEP 2106.05(g))
Dependent claims recite additional subject matter which amount to limitations consistent with the additional elements in the independent claims (such as claims 6-11, 14 recite additional limitations which amount to invoking computers as a tool to perform the abstract idea, and claims 6-11, 14 additional limitations which generally link the abstract idea to a particular technological environment or field of use). Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation and do not impose a meaningful limit to integrate the abstract idea into a practical application.
Step 2B of the Alice/Mayo Test for Claims
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to discussion of integration of the abstract idea into a practical application, the additional elements amount to no more than mere instructions to apply an exception and add insignificant extra-solution activity to the abstract idea. Additionally, the additional elements, other than the abstract idea per se, amount to no more than elements which:
amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields (such as using the medical information processing apparatus, processing circuitry, communication interface, output interface, computer, computer-readable non-transitory storage medium storing a program for being executed by a computer, radiation treatment planning system, neural network, neural network trained on training data, e.g., Applicant’s spec describes the computer system with it being well-understood, routine, and conventional because it describes in a manner that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such elements to satisfy 112a. (See Applicant’s Spec. [0019]-[0024], [0030]-[0031], [0065]-[0070]); using a computer-readable non-transitory storage medium storing a program for being executed by a computer, interface, processing circuitry, system, neural network, neural network trained on training data, e.g., merely adding a generic computer, generic computer components, or a programmed computer to perform generic computer functions, Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 134 S. Ct. 2347, 2358-59, 110 USPQ2d 1976, 1983-84 (2014).
adding insignificant extrasolution activity to the abstract idea, for example mere data gathering, selecting a particular data source or type of data to be manipulated, and/or insignificant application. The following represent examples that courts have identified as insignificant extrasolution activities (e.g. see MPEP 2106.05(g)): outputting the prognosis via the output interface, e.g., outputting or providing access to the information, Symantec, 838 F.3d at 1321 and MPEP 2106.05(g)(3)).
Dependent claims recite additional subject matter which, as discussed above with respect to integration of the abstract idea into a practical application, amount to invoking computers as a tool to perform the abstract idea and are generally linking the abstract idea to a particular field of environment. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation. Therefore, the claims are not patent eligible, and are rejected under 35 U.S.C. § 101.
Subject Matter Free of Prior Art
Claims 1, 6-14 are free of prior art over Taub (US 2020/0321091) in view of Braido et al. (US 2021/0369393). The prior art references, or reasonable combination thereof, could not be found to disclose, or suggest all of the limitations found in the independent claims. The closest prior art is Taub (US 2020/0321091), which teaches a system for estimating efficacy of a specific treatment line for an individual having a certain disease and undergoing treatment by the specific treatment line. Braido et al. (US 2021/0369393) teaches using targeted radiation treatments to treat the patient’s condition. The references do not teach or suggest, in combination with the claim’s other recited limitations, estimating the timings, frequencies, and symptom severities of adverse events that occur in the treatment target by using a radiation tolerance criteria of the treatment conditions to be applied to the treatment target.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMANDA R COVINGTON whose telephone number is (303)297-4604. The examiner can normally be reached Monday - Friday, 10 - 5 MT.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jason B. Dunham can be reached on (571) 272-8109. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/AMANDA R. COVINGTON/Examiner, Art Unit 3686
/JASON B DUNHAM/Supervisory Patent Examiner, Art Unit 3686