!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 Amendment
This action is in response to the amendments filed on 05/06/2026. Claims 1, 3-11, and 13-15 are amended. Claims 1-15 are examined below.
The Examiner notes that at least claim 1 was not marked up properly in reference to the previous claims and is non-compliant. However, in order to expedite prosecution, the Examiner shall proceed with examination of the claims.
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 1-15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Claim 1 recites (additional elements crossed out):
calculate a development progress degree of a second drug of which disease or symptom indication corresponds to that of a first drug for which a clinical trial is to be planned, wherein the development progress is calculated as a maximum value of a product of a response rate and a trial phase of the second drug based on clinical trial design data of a competitor drug indicating a situation of a clinical trial related to the second drug, and
generate a clinical trial plan by optimization using
The above limitations as drafted, is a process that, under its broadest reasonable interpretation covers managing personal behavior or relationships or interactions between people, and mental processes. That is, other than reciting the steps as being performed by a “clinical trial planning device comprising a clinical trial planning unit” and a “reinforcement learning model” nothing in the claim precludes the steps as being described as managing personal behavior or relationships or interactions between people, and mental processes. For example, but for the recited “clinical trial planning device comprising a clinical trial planning unit” and “reinforcement learning model”, the limitations describe a system for calculating a development progress degree using a mathematical calculation, and generating a clinical trial plan optimization based in part on the development progress degree. The limitations describe the management of personal behavior, as well as actions that can be performed mentally or with pen and paper, and mathematical calculations. If a claim limitation, under its broadest reasonable interpretation, describes managing personal behavior or relationships or interactions between people, then it falls within the “Certain Methods of Organizing Human Activities” grouping of abstract ideas. Further, if a claim limitation, under its broadest reasonable interpretation, describes steps that may be performed mentally or with pen and paper, then it falls within the “Mental Processes” grouping of abstract ideas. Moreover, if a claim limitation, under its broadest reasonable interpretation, features mathematical calculations, then it falls within the “Mathematical Concepts” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
The judicial exception is not integrated into a practical application. In particular, the claims recite the additional elements of “clinical trial planning device comprising a clinical trial planning unit” to perform the steps. These additional elements are recited at a high level of generality (see at least Paras. [0036]-[0038]) such that it amounts to no more than mere instructions to apply the exception using generic computing components. The claims further recite “generate a clinical trial plan optimization using a reinforcement learning model…”. However, the “using” of the model is recited at such a high level of generality that the functions performed by the reinforcement learning model may be described as an abstract idea in the “mental process” category or in the “mathematical concepts” category, but for which it is simply automated (i.e., “apply it”).
Accordingly, the additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. More specifically, the additional elements fail to include (1) improvements to the functioning of a computer or to any other technology or technical field (see MPEP 2106.05(a)), (2) applying or using a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition (see Vanda memo), (3) applying the judicial exception with, or by use of, a particular machine (see MPEP 2106.05(b)), (4) effecting a transformation or reduction of a particular article to a different state or thing (see MPEP 2106.05(c)), or (5) applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception (see MPEP 2106.05(e) and Vanda memo).
Rather, the limitations merely add the words “apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea (see MPEP 2106.05(f)) or generally link the use of the judicial exception to a particular technological environment or field of use (see MPEP 2106.05(h)), particularly as it relates to the recited “clinical trial planning device comprising a clinical trial planning unit” and “reinforcement learning model” elements. Therefore the claims are directed to ineligible subject matter..
Claim 13 recites (additional limitations crossed out):
A clinical trial planning method
a first step of reading a plurality of trial designs defining a disease or symptom indication and a number of samples, related to a first drug;
a second step of reading a plurality of clinical trial design data of competitor drugs defining a disease or symptom indication and a trial phase, related to a second drug;
a third step of specifying clinical trial design data of a competitor drug having the same disease or symptom indication from the clinical trial design data of competitor drugs for each of the trial designs;
a fourth step of calculating a development progress degree based on the trial phase of the clinical trial design data of a competitor drug specified for each of the trial designs;
a fifth step of calculating a trial period based on the number of samples for each of the trial designs;
a sixth step of calculating expected sales based on a market scale and the development progress degree for each of the trial designs; and
a seventh step of generating a clinical trial plan made by a combination of the trial designs by using a
The above limitations as drafted, is a process that, under its broadest reasonable interpretation covers managing personal behavior or relationships or interactions between people, and mental processes. That is, other than reciting the steps as being performed by an “information processing device” having at least a “clinical trial planning unit”, and a “reinforcement learning model” nothing in the claim precludes the steps as being described as managing personal behavior or relationships or interactions between people, and mental processes. For example, but for the recited “information processing device” having at least a “clinical trial planning unit”, and “reinforcement learning model”, the limitations describe a method for reading a plurality of trial designs related to a first drug, reading a plurality of competitive drug designs related to a second drug, specifying a competitive drug design, calculating a development progress degree, calculating a trial period, calculating expected sales, and generating a clinical trial plan using a mathematical calculation (i.e., minimization and maximization). The limitations describe the management of personal behavior, actions that can be performed mentally or with pen and paper, and the use of mathematical calculations. If a claim limitation, under its broadest reasonable interpretation, describes managing personal behavior or relationships or interactions between people, then it falls within the “Certain Methods of Organizing Human Activities” grouping of abstract ideas. Further, if a claim limitation, under its broadest reasonable interpretation, describes steps that may be performed mentally or with pen and paper, then it falls within the “Mental Processes” grouping of abstract ideas. Moreover, if a claim limitation, under its broadest reasonable interpretation, features mathematical calculations, then it falls within the “Mathematical Concepts” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
The judicial exception is not integrated into a practical application. In particular, the claims recite the additional elements of an “information processing device” having at least a “clinical trial planning unit” to perform the steps. These additional elements are recited at a high level of generality (see at least Paras. [0036]-[0038]) such that it amounts to no more than mere instructions to apply the exception using generic computing components. The claims further recite “a seventh step of generating a clinical trial plan made by a combination of the trial designs by using a reinforcement learning model…”. However, the “using” of the model is recited at such a high level of generality that the functions performed by the reinforcement learning model may be described as an abstract idea in the “mental process” category or in the “mathematical concepts” category, but for which it is simply automated (i.e., “apply it”).
Accordingly, the additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. More specifically, the additional elements fail to include (1) improvements to the functioning of a computer or to any other technology or technical field (see MPEP 2106.05(a)), (2) applying or using a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition (see Vanda memo), (3) applying the judicial exception with, or by use of, a particular machine (see MPEP 2106.05(b)), (4) effecting a transformation or reduction of a particular article to a different state or thing (see MPEP 2106.05(c)), or (5) applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception (see MPEP 2106.05(e) and Vanda memo).
Rather, the limitations merely add the words “apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea (see MPEP 2106.05(f)) or generally link the use of the judicial exception to a particular technological environment or field of use (see MPEP 2106.05(h)), particularly as it relates to the recited “information processing device” having at least a “clinical trial planning unit”, and “reinforcement learning model” elements. This is not sufficient to amount to significantly more than the judicial exception. The claims are therefore still directed to an abstract idea.
Claims 2-12 are dependent on claim 1, and include all the limitations of claim 1. Claims 14-15are dependent on claim 13, and include all the limitations of claim 16. Therefore, they are also found to be directed to an abstract idea. The remaining dependent claims have not been found to integrate the judicial exception into a practical application, or provide significantly more than the abstract idea since they merely further narrow the abstract idea. Therefore, the dependent claims are found to be directed to an abstract idea without significantly more.
Examiner Notes
No prior art could be found at this time that teaches the perceived functions of the claim. For example, while the concept of “benchmarking” competing products is a well-known business method, no prior art could be found in regards to calculating a score for a competitor’s drug and optimizing a clinical time period and expected sales for a drug based on the score.
Response to Arguments
Applicant's arguments regarding claims rejected under 35 U.S.C. 101 have been fully considered but they are not persuasive. Applicant argues with substance:
Applicant argues that the claims are directed to a particular computer-implemented planning technique. This is not persuasive. The fact that the claims are “computer-implemented” does not make the claims any less abstract. The recitation of any involved computing elements amounts to no more than mere instructions to apply the exception using generic computing components.
Applicant argues that the claims cannot be performed in the mind, and further argues that the operations of the claim require “machine-executed processing of structured trial-design data and structured competitor clinical trial design data, generation of derived values, and optimization across combinations allocated to predetermined trial processes” and therefore cannot be performed in the human mind or with pen and paper. This is not persuasive as this is merely a conclusory statement. The Examiner further points out that the claims not only recite “Mental Processes”, but “Certain Methods of Organizing Human Activity” and “Mathematical Concepts” as well.
Applicant argues that the claims are integrated into a practical application. The Examiner respectfully disagrees as the claims does not disclose features indicative of a practical application. As stated above in the body of the 101 rejection, “the additional elements fail to include (1) improvements to the functioning of a computer or to any other technology or technical field (see MPEP 2106.05(a)), (2) applying or using a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition (see Vanda memo), (3) applying the judicial exception with, or by use of, a particular machine (see MPEP 2106.05(b)), (4) effecting a transformation or reduction of a particular article to a different state or thing (see MPEP 2106.05(c)), or (5) applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception (see MPEP 2106.05(e) and Vanda memo). Even if the claims “solve the problem that a competitor may market a similar-indication drug first, thereby reducing differentiation and revenue”, this problem is not technological in nature. If anything, it is a problem related to business methods.
Applicant argues that the claims amount to “significantly more” as they do not merely invoke a generic computer as a tool. The Examiner respectfully disagrees and points to paragraph [0036] of the specification which states, in part, “The configuration can be realized by using an information processing device such as a general server, a personal computer, or the like.” Thus it is apparent that the claims invoke a generic computer as a tool.
Applicant argues that the claimed combination is not well-understood, routine, and conventional due to the lack of prior art. This is not persuasive. Even if a claim were found to contain novel elements, such a conclusion would not automatically transform the claim into patentable subject matter. It is possible for an abstract idea or other judicial exception to be novel while still remaining a judicial exception. Determination of novelty under 35 U.S.C. 102 and 103 are a separate inquiry than determinations of patent subject matter eligibility under 35 U.S.C. 101.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
“Competitive Benchmarking Tactics for the Pharmaceutical Industry in the Age of Social Media? | Q&A with Yann Guilain, Digimind”1 by Kevin Tran, available October 29, 2019 discusses competitive intelligence strategies due to the costly development of clinical trial phases.
“Strategies for success with comparator clinical trials”2 by Linda Banks, available June 8, 2018 discusses the use of comparator drugs in clinical trials
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 KYLE G ROBINSON whose telephone number is (571)272-9261. The examiner can normally be reached Monday - Thursday, 7:00 - 4:30 EST; Friday 7:00-11:00 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kambiz Abdi can be reached at 571-272-6702. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KYLE G ROBINSON/Examiner, Art Unit 3685
/KAMBIZ ABDI/Supervisory Patent Examiner, Art Unit 3685
1 Available at https://blog.digimind.com/en/competitive-intelligence/competitive-benchmarking-tactics-for-pharma-industry-with-yann-guilain
2 Available at https://pharmaphorum.com/views-and-analysis/strategies-success-comparator-clinical-trials#:~:text=Comparator%20studies%20typically%20focus%20on,product%20to%20the%20existing%20drug.
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