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.
Step 1
Claims 1-18 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Claims 1-18 are directed to a process; thus, each of the pending claims are directed to a statutory category of invention.
Step 2A Prong One
Claim 1, representative of the claimed invention, recites the steps of conducting an initial assessment of the patient in an assessment domain, wherein the assessment domain is one of a self-care domain, a mobility domain, and a cognition domain, and wherein the initial assessment of the patient is conducted at a first time point using a plurality of assessment items; calculating an initial domain-specific item response theory (IRT) score for the patient in the assessment domain by performing IRT analysis using data about performance by the patient on the plurality of assessment items in the initial assessment; generating, using a predictive model, a predicted domain-specific IRT score for the patient in the assessment domain at a future time point that is later than the first time point: conducting a follow-up assessment of the patient in the assessment domain at the future time point: calculating an actual domain-specific IRT score for the patient in the assessment domain by performing IRT analysis using data about performance by the patient in the follow-up assessment; and assessing a treatment plan for the patient based on a comparison of the generated actual domain-specific IRT score to the predicted domain-specific IRT score.
The limitations above, as drafted, recite a process that, under its broadest reasonable interpretation, encompass mental processes and also certain methods of organizing human activity. The claimed steps recite several steps that include observations, evaluations, judgments and opinions, and “can be performed in the human mind, or by a human using a pen and paper” which have been considered by the courts to be a mental process. CyberSource Corp. v. Retail Decisions, Inc., 654 F.3d 1366, 1372, 99 USPQ2d 1690, 1695 (Fed. Cir. 2011). The courts do not distinguish between claims that recite mental processes performed by humans and claims that recite mental processes performed on a computer. Versata Dev. Group v. SAP Am., Inc., 793 F.3d 1306, 1335, 115 USPQ2d 1681, 1702 (Fed. Cir. 2015). See also Intellectual Ventures I LLC v. Symantec Corp., 838 F.3d 1307, 1318, 120 USPQ2d 1353, 1360 (Fed. Cir. 2016) (‘‘[W]ith the exception of generic computer-implemented steps, there is nothing in the claims themselves that foreclose them from being performed by a human, mentally or with pen and paper.’’); Mortgage Grader, Inc. v. First Choice Loan Servs. Inc., 811 F.3d 1314, 1324, 117 USPQ2d 1693, 1699 (Fed. Cir. 2016) (holding that computer-implemented method for "anonymous loan shopping" was an abstract idea because it could be "performed by humans without a computer"). The claimed steps also are directed towards managing personal behavior (e.g., instructing a human in performing assessments of patients and assessing treatment plans).
Apart from the use of generic technology (discussed further below), each of the limitations recited above describes activities that would encompass actions performed in performing assessments of patients and assessing treatment plans.
Based on the broadest reasonable interpretation in light of the specification, these activities describe concepts relating to managing personal behavior and mental processes in that the activities relate to performing assessments of patients and assessing treatment plans. If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or relationships or interactions between people, commercial interactions, or fundamental economic practices, then it falls within the “Method of Organizing Human Activity” grouping of abstract ideas. The recited steps also are considered to be a mental process as methods that can be performed mentally, or which are the equivalent of human mental work. Accordingly, the claim recites an abstract idea.
Step 2A Prong 2
This judicial exception is not integrated into a practical application. In particular, claims 1 and 11 recite the additional elements of a predictive model. No computer is claimed. The model is implemented as a tool to perform an abstract idea. The claim is directed to an abstract idea.
This judicial exception is not integrated into a practical application because no additional elements are recited. The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception.
Similarly, a machine learning model per se is a tool to perform the abstract idea. See MPEP 2106.05(f): “[u]se 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.” An example where the courts have found the additional elements to be mere instruction to apply an exception, because they do no more than merely invoke computers or machinery as a tool to perform an existing process includes a commonplace business method or mathematical algorithm being applied on a general purpose computer, Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 573 U.S. 208, 223 (MPEP 2106.05(f)(2)). The use of a machine learning model emulates what the medical practitioner does in assessing a patient treatment. Thus, even considering the additional elements in combination, the claims do not include elements that are significantly more than the judicial exception.
Step 2B
Limitations that the courts have found to qualify as “significantly more” when recited in a claim with a judicial exception include:
i. Improvements to the functioning of a computer, e.g., a modification of conventional Internet hyperlink protocol to dynamically produce a dual-source hybrid webpage, as discussed in DDR Holdings, LLC v. Hotels.com, L.P., 773 F.3d 1245, 1258-59, 113 USPQ2d 1097, 1106-07 (Fed. Cir. 2014) (see MPEP § 2106.05(a));
ii. Improvements to any other technology or technical field, e.g., a modification of conventional rubber-molding processes to utilize a thermocouple inside the mold to constantly monitor the temperature and thus reduce under- and over-curing problems common in the art, as discussed in Diamond v. Diehr, 450 U.S. 175, 191-92, 209 USPQ 1, 10 (1981) (see MPEP § 2106.05(a));
iii. Applying the judicial exception with, or by use of, a particular machine, e.g., a Fourdrinier machine (which is understood in the art to have a specific structure comprising a headbox, a paper-making wire, and a series of rolls) that is arranged in a particular way to optimize the speed of the machine while maintaining quality of the formed paper web, as discussed in Eibel Process Co. v. Minn. & Ont. Paper Co., 261 U.S. 45, 64-65 (1923) (see MPEP § 2106.05(b));
iv. Effecting a transformation or reduction of a particular article to a different state or thing, e.g., a process that transforms raw, uncured synthetic rubber into precision-molded synthetic rubber products, as discussed in Diehr, 450 U.S. at 184, 209 USPQ at 21 (see MPEP § 2106.05(c));
v. Adding a specific limitation other than what is well-understood, routine, conventional activity in the field, or adding unconventional steps that confine the claim to a particular useful application, e.g., a non-conventional and non-generic arrangement of various computer components for filtering Internet content, as discussed in BASCOM Global Internet v. AT&T Mobility LLC, 827 F.3d 1341, 1350-51, 119 USPQ2d 1236, 1243 (Fed. Cir. 2016) (see MPEP § 2106.05(d)); or
vi. Other meaningful limitations beyond generally linking the use of the judicial exception to a particular technological environment, e.g., an immunization step that integrates an abstract idea of data comparison into a specific process of immunizing that lowers the risk that immunized patients will later develop chronic immune-mediated diseases, as discussed in Classen Immunotherapies Inc. v. Biogen IDEC, 659 F.3d 1057, 1066-68, 100 USPQ2d 1492, 1499-1502 (Fed. Cir. 2011) (see MPEP § 2106.05(e)).
Claims 1 and 11 are not similar to any of these limitations.
Limitations that the courts have found not to be enough to qualify as “significantly more” when recited in a claim with a judicial exception include:
i. Adding the words “apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, e.g., a limitation indicating that a particular function such as creating and maintaining electronic records is performed by a computer, as discussed in Alice Corp., 573 U.S. at 225-26, 110 USPQ2d at 1984 (see MPEP § 2106.05(f));
ii. Simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known to the industry, as discussed in Alice Corp., 573 U.S. at 225, 110 USPQ2d at 1984 (see MPEP § 2106.05(d));
iii. Adding insignificant extra-solution activity to the judicial exception, e.g., mere data gathering in conjunction with a law of nature or abstract idea such as a step of obtaining information about credit card transactions so that the information can be analyzed by an abstract mental process, as discussed in CyberSource v. Retail Decisions, Inc., 654 F.3d 1366, 1375, 99 USPQ2d 1690, 1694 (Fed. Cir. 2011) (see MPEP § 2106.05(g)); or
iv. Generally linking the use of the judicial exception to a particular technological environment or field of use, e.g., a claim describing how the abstract idea of hedging could be used in the commodities and energy markets, as discussed in Bilski v. Kappos, 561 U.S. 593, 595, 95 USPQ2d 1001, 1010 (2010) or a claim limiting the use of a mathematical formula to the petrochemical and oil-refining fields, as discussed in Parker v. Flook, 437 U.S. 584, 588-90, 198 USPQ 193, 197-98 (1978) (MPEP § 2106.05(h)).
Claims 1 and 11 recite additional elements that are regarded as “apply it” as seen in the Step 2A Prong 2 discussion above. The claims do not set forth a solution to a problem rooted in technology (e.g., technical solution), assessing patients and treatment plans predate the use of computers or machine learning models.
Looking at the limitations of claims 1 and 11 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, effects a transformation of subject matter to a different state or thing, applies the use of a particular machine, integrate the abstract idea into a practical application or provide any meaningful limitations beyond generally linking the use of the judicial exception to a particular technological environment.
Therefore, claims 1 and 11 are not patent eligible.
The dependent claims further describe the abstract idea and do not recite a practical application or significantly more than the judicial exception. None of dependent claims 2-10 or 12-18 recite any further additional elements.
Dependent claims 2, 10, 16, and 17 further narrow the model of the independent claims, it still is recited as a tool to perform the abstract idea. It does not provide a practical application or significantly more than the abstract idea. Thus, claims 1-18 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Allowable Subject Matter
Claims 1-18 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
Conclusion
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/ELIZA A LAM/Primary Examiner, Art Unit 3681
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