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 .
Priority
Acknowledgment is made of Applicant's claim for priority to the following application(s):
* 18621944 filed 03/29/2024
Claim Objections
Claims 10-14 are objected to because of the following informalities:
Claim 10 recites, inter alia:
developing a machine learning, advanced decisioning, and/or language model based on a plurality of candidate variables that
indication from medications;
medication types of the medications;
cost of therapy for the medications;
special storage conditions for the medications;
requirements for administration by health-care providers;
inclusion in a risk evaluation and mitigation program;
adverse effect complexity;
clinical complexity;
medication monitoring complexity; and
patient engagement complexity.
In particular, this claim lacks a transitional phrase between “that” and the variables listed.
Claims 11-14 are also objected through dependence as being dependent on parent claim 10 for the same rationale.
Appropriate correction is requested.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 101 because the claimed invention is directed to abstract idea without significantly more.
Claim 1 recites:
A system, comprising:
one or more processors; and
memory, storing instructions for execution by the one or more processors, including instructions for:
obtaining a request for classification determination of a medication;
extracting, based on scoring model variables, relevant data of the medication from at least one database;
computing, using the scoring model, a score for the medication based on the relevant data;
generating, based on the score, a medication classification; and
transmitting at least one of the classification or score to a user.
Step 1:
The claim as a whole falls within at least one statutory category, i.e. a process, machine, manufacture, or composition of matter.
Step 2A Prong One:
The highlighted portion, as drafted, is a process that, under its broadest reasonable interpretation, falls under “Certain methods of organizing human activity” because the steps of scoring a medication for classification are traditionally performed by a human being when classifying medications used to treat a patient, i.e. managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions). MPEP 2106.04(a)(2)(II)
The highlighted portion, as drafted, is a process that, under its broadest reasonable interpretation, falls under “Mental processes”.
But for a generic computer recited with a high level of generality in a post hoc manner to implement the abstract idea, the highlighted portions may be practically performed in the human mind either mentally or with pen and paper.
Accordingly, these limitations have been found to be directed towards concepts performed in the human mind (including an observation, evaluation, judgment, opinion). MPEP 2106.04(a)(2)(III)
The different categories of abstract ideas are being considered together as one single abstract idea. MPEP 2106.04(II)(B)
Dependent claim(s) recite(s) additional subject matter which further narrows or defines the abstract idea embodied in the claims (such as claim(s) 2-15 reciting limitations further defining the abstract idea, which may be performed in the mind but for recitation of generic computer components, and/or may be a method of managing relationship or interactions between people).
Step 2A Prong Two:
This judicial exception is not integrated into a practical application. In particular, the claim recites the following additional element(s), if any:
one or more processors; and
memory, storing instructions for execution by the one or more processors, including instructions for:
obtaining a request for classification determination of a medication; and
transmitting at least one of the classification or score to a user.
The additional element(s) do(es) not integrate the abstract idea into a practical application, other than the abstract idea per se.
The processor and associated memory amount(s) to mere instructions to apply an exception (invoking computers as a tool to perform the abstract idea). MPEP 2106.05(f))
The steps of sending and receiving data merely add(s) insignificant extra-solution activity to the abstract idea (mere data gathering, insignificant application). MPEP 2106.05(g))
Dependent claim(s) recite(s) additional subject matter which amount to limitation(s) consistent with the additional element(s) in the independent claims (such as claim(s) 10 reciting ML/advanced decisioning/LM, additional limitation(s) which amount(s) to invoking computers as a tool to perform the abstract idea, claim 15 reciting sending data, additional limitation(s) which add(s) insignificant extra-solution activity to the abstract idea).
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.
Accordingly, the additional elements do not integrate the judicial exception into a practical application because it does not impose any meaningful limits on practicing the abstract idea.
Accordingly, the claim recites an abstract idea.
Step 2B:
The claim does 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 elements amount to no more than mere instructions to apply an exception, add insignificant extra-solution activity to the abstract idea, and/or generally link the abstract idea to a particular technological environment or field of use.
The additional elements, as discussed above and incorporated herein, amount to no more than mere instructions to apply an exception, add insignificant extra-solution activity to the abstract idea, and/or generally link the abstract idea to a particular technological environment or field of use, as discussed above and incorporated herein.
Mere instructions to apply an exception, insignificant extra-solution activity, and linking to a particular technological environment using a generic computer component cannot provide an inventive concept.
The steps of sending and receiving data amount(s) to element(s) that have been recognized as well-understood, routine, and conventional activity in particular fields (e.g., receiving or transmitting data over a network, Symantec, MPEP 2106.05(d)(II)(i)). MPEP 2106.05(d)(II)(ii))
Dependent claims recite additional subject matter which amount to limitations consistent with the additional elements in the independent claims (such as claim(s) 15 reciting sending data, e.g., receiving or transmitting data over a network, Symantec, MPEP 2106.05(d)(II)(i)). MPEP 2106.05(d)(II)(ii))
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.
The claim is not patent eligible.
Claim(s) 16-20 recite(s) substantially similar limitations as those of claim(s) 1-3 above, and are therefore rejected for substantially similar rationale as applied above, and incorporated herein.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-7, 15-20 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Bajpai (11127488).
Claim 1: Bajpai discloses:
A system (Title illustrating a system), comprising:
one or more processors (column 6 line 6-10 illustrating a processor); and
memory (column 6 line 30-32 illustrating a memory), storing instructions for execution by the one or more processors, including instructions for:
obtaining a request for classification determination of a medication (Figure 3 label 302 illustrating selecting a drug for processing);
extracting, based on scoring model variables, relevant data of the medication from at least one database (column 4 line 9-30 illustrating extracting features for the drug);
computing, using the scoring model, a score for the medication based on the relevant data (column 19 line 1-17 illustrating scoring the features of the drugs);
generating, based on the score, a medication classification (column 19 line 1-17 illustrating comparing the drug’s score against a threshold to determine if the drug is above or below the threshold [considered to be a form of “classification”]); and
transmitting at least one of the classification or score to a user (Figure 3 label 322 illustrating providing recommendations based on the drug’s score threshold comparison to the user).
Claim 2: Bajpai discloses:
wherein:
the classification determination is a clinical complexity classification (Figure 3 label 314 illustrating adding the drug to a cluster used to indicate therapeutic effectiveness [considered to be a form of “complexity classification”]);
the score for the medication indicates the degree or probability of association of the medication with clinical complexity classification (Figure 3 label 314 illustrating scoring the drug’s effectiveness at treating diseases in the cluster [considered to be a form of “degree or probability” indicating whether the drug belongs in the cluster and should be used to treat the indicated disease]); and
the classification indicates the level of clinical complexity for the medication (Figure 3 label 314 illustrating that the cluster indicates the therapeutic class of the drug).
Claim 3 is rejected for substantially similar rationale as applied to claim 2 above, and incorporated herein.
Specifically, despite a difference in wording of claim 3 as being a specialty drug, the broadest reasonable interpretation would place this within the disclosure as applied to claim 2 above, and incorporated herein.
Claim 4: Bajpai discloses:
wherein the relevant data includes as least one of medication guide content, medication warming content, a disease complexity (column 2 line 25-30 illustrating determining how effective the drug’s molecule at binding to the disease site), a cost of therapy, a medication volume, a medication spend, or medication distribution factors.
The remaining limitations are rendered optional by the limitation “or” and therefore need not be disclosed by the applied art.
Claim 5: Bajpai discloses:
wherein computing the score for the medication includes assigning a respective score to each respective piece of the relevant data and summing the respective scores for each respective piece of the relevant data (column 18 line 63-66 illustrating calculating a composite score comprising a plurality of sub-scores).
Claim(s) 6 recite(s) substantially similar limitations as those of claim(s) 5 above, and are therefore rejected for substantially similar rationale as applied above, and incorporated herein.
Claim 7: Bajpai discloses:
wherein:
the relevant data comprises an adverse effect complexity code indicating a degree of adverse effect resulting from the medication (column 12 line 50-55 illustrating determining the drug’s effectiveness); and
the adverse effect complexity code is one of: low, moderate or high, or similar assigned range based on an input of an expert and at least one predetermined rule (column 12 line 50-55 illustrating supervised learning [considered to be a form of “expert” and “rule”]).
Claim 15: Bajpai discloses:
transmitting both the classification and the score to the user (Figure 3 label 322 illustrating displaying the score and the threshold recommendation).
Claim(s) 16-20 recite(s) substantially similar limitations as those of claim(s) 1-3 above, and are therefore rejected for substantially similar rationale as applied above, and incorporated herein.
Claim Rejections - 35 USC § 103
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(s) 8-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bajpai in view of Ross-Howe (12383197).
Claim 8: Bajpai discloses:
wherein:
Bajpai does not disclose:
the relevant data comprises a monitoring complexity code indicating a degree of monitoring needed for a patient taking the medication.
Ross-Howe discloses:
the relevant data comprises a monitoring complexity code indicating a degree of monitoring needed for a patient taking the medication (column 1 line 54-60 illustrating patient monitoring needed to improve the drug’s effectiveness).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to include the effectiveness determination of Ross-Howe within the system of Bajpai with the motivation of improving patient care by predicting drug effectiveness before treating the patient with such drug (Ross-Howe; column 1 line 54-60).
Claim 9: Bajpai discloses:
wherein:
Bajpai does not disclose:
the relevant data comprises a patient engagement critical to success code indicating a degree of patient engagement needed for a therapy based on the medication to be successful.
Ross-Howe discloses:
the relevant data comprises a patient engagement critical to success code indicating a degree of patient engagement needed for a therapy based on the medication to be successful (column 1 line 54-60 illustrating patient involvement needed to improve the drug’s effectiveness).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to include the effectiveness determination of Ross-Howe within the system of Bajpai with the motivation of improving patient care by predicting drug effectiveness before treating the patient with such drug (Ross-Howe; column 1 line 54-60).
Subject Matter Free of Prior Art
Claim(s) 10-14 distinguish(es) over the prior art for the following reasons.
The following is a statement of reasons for the subject matter free of prior art:
Claim 10: the primary reason for the indication of subject matter free of prior art is the inclusion of the following limitations in the combination as recited in the abstract concept and not found in the closest available prior art of record:
wherein the memory further includes instructions for developing a machine learning, advanced decisioning, and/or language model based on a plurality of candidate variables that
indication from medications;
medication types of the medications;
cost of therapy for the medications;
special storage conditions for the medications;
requirements for administration by health-care providers;
inclusion in a risk evaluation and mitigation program;
adverse effect complexity;
clinical complexity;
medication monitoring complexity; and
patient engagement complexity.
The closest available prior art of record are as follows:
Bajpai discloses AI and ML (Abstract), but does not fairly disclose or suggest using the variables as recited to classify the drug.
Based on the evidence presented above, none of the closest available prior art of record fairly discloses or suggests the claimed invention. For this reason, claim 10 would be found to be subject matter free of prior art.
Claim(s) 11-14: this/these claim(s) would also be found to be subject matter free of prior art for at least the same rationale as applied to parent claim 10 above, and incorporated herein.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Benner (11334902) discloses determining patient data for drug effectiveness (column 6 line 5-10) in a manner similar to those disclosed in the instant pending Specification as originally filed.
Mills (20210295971) discloses a drug risk mitigation program (page 14 paragraph 0122) in a manner similar to those disclosed in the instant pending Specification as originally filed
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/T.N.N./ Examiner, Art Unit 3685
/KAMBIZ ABDI/ Supervisory Patent Examiner, Art Unit 3685
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