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 .
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):
generates a clinical trial plan obtained by optimizing a period of a clinical trial of the first drug and expected sales of the first drug on the basis of the development progress degree.
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” 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”, the limitations describe a system for calculating a development progress degree, and generating a clinical trial plan 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. 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. 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.
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” 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 patient indication and the number of samples, related to a first drug;
a second step of reading a plurality of competitive drug designs defining a patient indication and a trial phase, related to a second drug;
a third step of specifying a competitive drug design having the same patient indication from the competitive drug designs for each of the trial designs;
a fourth step of calculating a development progress degree on the basis of the trial phase of the competitive drug design specified for each of the trial designs;
a fifth step of calculating a trial period on the basis of the number of samples for each of the trial designs;
a sixth step of calculating expected sales on the basis of 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 reward function having the trial period and the expected sales as variables, for a combination of the trial designs allocated to trial processes of the number which is preliminarily determined.
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” 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”, 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. The limitations describe the management of personal behavior, as well as actions that can be performed mentally or with pen and paper. 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. 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.
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” 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. Claim 11 recites “the optimization is performed by a reinforcement learning method using a reward function with the mathematical formula being as the reward function”, and Claim 14 recites “an optimum plan model generated by reinforcement learning using miniaturization of the total sum of the trial period and maximization of the total sum of the expected sales as rewards is used”. However the use of the additional element of reinforcement learning is considered to be generic computer function and/or field-of-use/”general link” implementations and does not meaningfully limit the claim (See Accenture, 728 F.3d 1336, 108 U.S.P.Q.2d 1173 (Fed. Cir. 2013), citing Cf. Diamond v. Diehr, 450 U.S. 175, 191-192 (1981) ("[I]nsignificant post-solution activity will not transform an unpatentable principle in to a patentable process.”). Accordingly, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The 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.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-15 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 1, the limitation “the clinical trial planning unit includes a development progress degree calculating unit calculating a development progress degree of a second drug of which patient indication corresponds to that of a first drug for which a clinical trial is to be planned, on the basis of a competitive drug design indicating a situation of a clinical trial related to the second drug” is indefinite. The manner in which the claim is written renders the metes and bounds of the claim unclear. The claims are generally narrative and indefinite, failing to conform with current U.S. practice. They appear to be a literal translation into English from a foreign document and are replete with grammatical and idiomatic errors. The Examiner notes that the specification does not appear to define what a “patient indication” or “competitive drug design” are. One of ordinary skill in the art would not understand what “patient indication” or “competitive drug design” mean, and therefore the scope of the claim unclear. For sake of examination, the Examiner interprets the limitation as, to paraphrase, calculating a development progress degree (i.e., value) of a second company’s (i.e., competitor’s) drug, wherein the second drug treats the same symptoms/disease as a first company’s drug.
Independent claim 13 is rejected as well. Although featuring differing steps, the claim also features the terms “patient indication” and “competitive drug design”, rendering it unclear as to what is actually being performed.
Dependent claims are rejected as well since they inherit the limitations of the independent claims.
Claim limitations “A clinical trial planning device comprising a clinical trial planning unit,…” (Claim 1) and “A clinical trial planning method which is executed by an information processing device having a control unit, a clinical trial planning unit, a storage unit, a display unit, and an input unit, wherein the clinical trial planning unit executes…” (Claim 13) invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The written description fails to provide any details regarding the structure of any of the claimed “units”. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
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.
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
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.