INTERNATIONAL BUSINESS MACHINES CORPORATION

Patent Trials and Appeals Board

Mar 21, 2022

2021003319 (P.T.A.B. Mar. 21, 2022)

UNITED STATES PATENT AND TRADEMARK OFFICE UNITED STATES DEPARTMENT OF COMMERCE United States Patent and Trademark Office Address: COMMISSIONER FOR PATENTS P.O. Box 1450 Alexandria, Virginia 22313-1450 www.uspto.gov APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO. 14/920,327 10/22/2015 Achille B. Fokoue-Nkoutche YOR920150940US1 3930 48915 7590 03/21/2022 CANTOR COLBURN LLP-IBM YORKTOWN 20 Church Street 22nd Floor Hartford, CT 06103 EXAMINER NAJARIAN, LENA ART UNIT PAPER NUMBER 3686 NOTIFICATION DATE DELIVERY MODE 03/21/2022 ELECTRONIC Please find below and/or attached an Office communication concerning this application or proceeding. The time period for reply, if any, is set in the attached communication. Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the following e-mail address(es): usptopatentmail@cantorcolburn.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte ACHILLE B. FOKOUE-NKOUTCHE, OKTIE HASSANZADEH, MOHAMMAD SADOGHI HAMEDANI, MEINOLF SELLMANN, and PING ZHANG Appeal 2021-003319 Application 14/920,327 Technology Center 3600 Before ANTON W. FETTING, NINA L. MEDLOCK, and BRADLEY. B. BAYAT, Administrative Patent Judges. BAYAT, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the Examiner’s decision to reject claims 8-10, 13-18, and 20, which constitute all pending claims in the application. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. 1 We use the word Appellant to refer to “applicant” as defined in 37 C.F.R. § 1.42(a). Appellant identifies the real party in interest as International Business Machines, Inc. Appeal Br. 1. Appeal 2021-003319 Application 14/920,327 2 CLAIMED SUBJECT MATTER The invention is directed to “PREDICTION OF ADVERSE DRUG EVENTS.” Spec., Title. Appellant’s “disclosure relates to prediction of adverse drug events and more specifically, to methods, systems and computer program products for analysis of data to provide personalized and detailed adverse drug events.” Id. ¶ 1. The Abstract section of the Specification describes the invention as follows: Embodiments include method, systems and computer program products for predicting adverse drug events on a computational system. Aspects include receiving known drug data from drug databases and one or more of a candidate drug, a drug pair, and a candidate drug-patient pair. Aspects also include calculating an adverse event prediction rating representing a confidence level of an adverse drug event for the candidate drug, a drug pair, and a candidate drug-patient pair, the rating being based on the known drug data. Aspects also include associating adverse event features with the candidate drug, drug pair, or a candidate drug-patient pair, including a nature, cause, mechanism, or severity of the adverse drug event. Aspects also include calculating and outputting an adverse event prediction rating. Independent claim 8, reproduced below, is illustrative of the claimed subject matter: 8. A computer program product for predicting adverse drug events on a computational system, the computer program product comprising a non- transitory storage medium readable by a processor and storing instructions for execution by the processor for performing a method comprising: receiving known drug data from one or more drug databases; receiving one or more of a candidate drug, a drug pair, and a candidate drug-patient pair; Appeal 2021-003319 Application 14/920,327 3 calculating, by the processor, an adverse event prediction rating for an adverse event, wherein calculating the adverse event prediction rating comprises: constructing one or more feature similarity tables comprises a plurality drug pairs and an associated feature similarity score for each drug pair in the plurality of drug pairs; constructing one or more adverse event feature tables comprising known adverse event features with associated known drugs or drug pairs, wherein the one or more adverse event features includes one or more of a nature, a cause, a mechanism, and a severity of the adverse drug event; constructing one or more multi-dimensional candidate adverse event tables based at least in part on the one or more feature similarity tables and the one or more adverse event feature tables; determining the adverse event prediction rating based on a feature vector, generated by a logistic regression model, comprising a plurality of features extracted from the one or more adverse event feature tables and the one or more multi-dimensional candidate adverse event tables, wherein the adverse event predicting rating representing a confidence level of an adverse drug event for the one or more of a candidate drug, a drug pair, and a candidate drug-patient pair; outputting the adverse event prediction rating and one or more potential outcomes of the adverse event; constructing one or more multi-dimensional drug profiles including multiple adverse event features for the one or more of a candidate drug, a drug pair, and a candidate drug-patient pair, wherein the adverse event Appeal 2021-003319 Application 14/920,327 4 prediction rating is further based on the one or more multi-dimensional drug profiles. REJECTIONS2 Claims 8-10, 13-18, and 20 are rejected under 35 U.S.C. § 101 as being directed to an abstract idea without significantly more. Claims 8-10, 13-18, and 20 are rejected under 35 U.S.C. § 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention. OPINION Rejection under 35 U.S.C. § 101 Under 35 U.S.C. § 101, an invention is patent eligible if it claims a “new and useful process, machine, manufacture, or composition of matter.” 35 U.S.C. § 101. The Supreme Court, however, has long interpreted § 101 to include an implicit exception: “[l]aws of nature, natural phenomena, and abstract ideas” are not patentable. Alice Corp. v. CLS Bank Int’l, 573 U.S. 208, 216 (2014). The Supreme Court, in Alice, reiterated the two-step framework previously set forth in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. 66 (2012), “for distinguishing patents that claim laws of nature, natural phenomena, and abstract ideas from those that claim patent-eligible applications of those concepts.” Alice Corp., 573 U.S. at 217. The first step in that analysis is to “determine whether the claims at issue are directed to one of those patent-ineligible concepts.” Id. If the claims are not directed to a patent-ineligible concept, e.g., an abstract idea, the inquiry 2 The non-statutory double patenting rejection is withdrawn. Ans. 3. Appeal 2021-003319 Application 14/920,327 5 ends. Otherwise, the inquiry proceeds to the second step where the elements of the claims are considered “individually and ‘as an ordered combination’” to determine whether there are additional elements that “‘transform the nature of the claim’ into a patent-eligible application.” Id. (quoting Mayo, 566 U.S. at 78, 79). This is “a search for an ‘inventive concept’ - i.e., an element or combination of elements that is ‘sufficient to ensure that the patent in practice amounts to significantly more than a patent upon the [ineligible concept] itself.’” Id. at 217-18 (alteration in original) (citation omitted). The USPTO has issued guidance with respect to that framework. 2019 Revised Patent Subject Matter Eligibility Guidance, 84 Fed. Reg. 50 (Jan. 7, 2019) (“Revised Guidance”). To determine if a claim is “directed to” an abstract idea, we evaluate whether the claim recites: (1) any judicial exceptions, including certain groupings of abstract ideas listed in the Revised Guidance (i.e., mathematical concepts, certain methods of organizing human activities such as a fundamental economic practice, or mental processes); and (2) additional elements that integrate the judicial exception into a practical application.3 Id. at 52-55. If a claim (1) recites a judicial exception and (2) does not integrate that exception into a practical application, we consider whether the claim (3) provides an inventive concept such as by adding a limitation beyond a judicial exception that is not “well- understood, routine, conventional” in the field or (4) appends well- 3 “A claim that integrates a judicial exception into a practical application will apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that the claim is more than a drafting effort designed to monopolize the judicial exception.” Revised Guidance, 84 Fed. Reg. at 54. Appeal 2021-003319 Application 14/920,327 6 understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception. Revised Guidance, 84 Fed. Reg. at 56. Appellant argues all claims together as a group. See Appeal Br. 5-10. We select claim 8 as representative of the group, with the remaining claims standing or falling therewith. 37 C.F.R. § 41.37(c)(1)(iv). Under Prong One of Step 2A, the Examiner determines that the unitalicized limitations in the body of claim 8 supra, under their broadest reasonable interpretation, “cover[ ] performance of the limitations in the mind and mathematical concepts (i.e., mathematical relationships, formulas/equations, or calculations) but for the recitation of generic computer components.” Final Act. 3 (“[O]her than reciting one or more databases, a computer program product, a non-transitory storage medium, a processor, processing system, a computational system, and memory used to perform the aforementioned limitations nothing in the claim elements precludes the steps from practically being performed in the mind.”). According to the Examiner, “[i]f a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind or mathematical concepts but for the recitation of generic computer components, then it falls within the ‘Mental Processes’ and ‘Mathematical Concepts’ groupings of abstract ideas.” Id. As such, the Examiner determines that claim 8 recites a judicial exception, i.e., an abstract idea. Id. Under Prong Two of Step 2A, the Examiner determines that the additional elements identified above “are recited at a high-level of generality (i.e., as generic computer components performing generic computer functions of receiving data, performing calculations, analyzing data, constructing data, and outputting data) such that [they] amount[ to] no more than mere Appeal 2021-003319 Application 14/920,327 7 instructions to apply the exception using generic computer components.” Id. at 3-4. According to the Examiner, “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.” Id. at 4. Under Step 2B, the Examiner finds that the additional elements, individually and in combination, are insufficient to amount to significantly more than the judicial exception and that “[m]ere instructions to apply an exception using a generic computer component cannot provide an inventive concept.” Id. Alleging error in the rejection, Appellant argues “that the claim limitations, as currently recited, cannot, as a practical matter, be performed entirely in a human’s mind, even if aided with pen and paper.” Appeal Br. 6. In particular, with respect to “determining the adverse event prediction rating based on a feature vector, generated by a logistic regression model, comprising a plurality of features extracted from the one or more adverse event feature tables and the one or more multi-dimensional candidate adverse event tables” recitation, Appellant argues that: after construction of the various feature tables taken from structured and unstructured data, the claims feature additional machine learning processing of this newly constructed data to determine and predict adverse effects from potential drug interactions with either another drug, with a specific patient, or with any patient, in general. The claimed features tie the claims to applications on a particular machine and also utilize the alleged exception in a meaningful way (e.g., beyond typical gerunds). The inclusion of these features shows that the claim limitations could not, as a practical matter, be performed entirely in a human’s mind. Id. at 6-7. Appellant also argues under Prong One of Step 2A that claim 8 “does not recite a mathematical concept (i.e., the claim limitations do not fall within the mathematical concept grouping), if it is only based on or involves Appeal 2021-003319 Application 14/920,327 8 a mathematical concept.” Id. at 7. Under Prong Two of Step 2A, citing the “constructing” limitations of claim 8, Appellant argues that those “claimed features, as a whole, integrate the alleged mental process into a practical application” because they “recite a specific manner of determining an adverse event prediction rating based on adding structure to unstructured medical data by constructing tables to organize the medical data.” Id. at 8. Appellant contends that “the challenge in the technological field exists as being able to accurately sort and analyze this vast amount of data to determine a specific drug-drug, drug-patient, drug-drug-patient risk analysis.” Id. at 9 (citing Spec. ¶ 3). Appellant repeats the arguments under Prong One of Step 2A in the Reply Brief. See Reply Br. 2-3. The Examiner responds that claim 8 recites “a ‘mental process’ because limitations such as receiving data, calculating a rating, and outputting the rating/potential outcomes amount to observations/evaluations/judgments/analyses that can, at the currently claimed high level of generality, be practically performed in the human mind or with pen and paper.” Ans. 4. Furthermore, regarding the “constructing ... tables” and “constructing ... profiles” limitations, the claims do not recite in detail how the tables/profiles are “constructed.” As such, at the currently claimed high level of generality, the tables and profiles could be constructed using pen and paper. In addition, a “logistic regression model” is a statistical model. Therefore, the limitation involving the “determining the adverse event prediction rating based on a feature vector, generated by a logistic regression model...” falls within the “mathematical concepts” grouping of abstract ideas. Id. We agree with the Examiner that the “constructing” limitations as recited describe a process that can be performed in the human mind or with Appeal 2021-003319 Application 14/920,327 9 pen and paper. This is evident from the tables shown and described in Appellant’s Specification. See Spec. ¶¶ 36-43. According to the Specification, “multiple known adverse event feature tables can be constructed. A known adverse event feature table can associate adverse event features with known drugs or drug pairs corresponding to those features. For example, a known adverse event feature table can provide a listing of all drug pairs associated with a particular adverse event, such as headache.” Spec. ¶ 42 (“a number (M) of known adverse event feature tables for adverse events of type 1 to M can be provided as dual column tables as follows:) Appeal 2021-003319 Application 14/920,327 10 And, even if we accept Appellant’s argument that “determining the adverse event prediction rating based on a feature vector, generated by a logistic regression model” does not properly fall into the mathematical concepts grouping because it merely involves a mathematical concept, we determine that performing logistic regression (Spec. Fig. 5 step 410) to provide an adverse event prediction rating based on comparing known drug data can be practically performed in the human mind and/or with pen and paper, especially considering the scope of the claim. The Federal Circuit has “treated analyzing information by steps people go through in their minds, or by mathematical algorithms, without more, as essentially mental processes within the abstract-idea category.” Elec. Power Grp., LLC v. Alstom S.A., 830 F.3d 1350, 1354 (Fed. Cir. 2016); see also CyberSource Corp. v. Retail Decisions, Inc., 654 F.3d 1366, 1372-73 (Fed. Cir. 2011) (holding that a claim whose “steps can be performed in the human mind, or by a human using a pen and paper” is directed to an “unpatentable mental process[]”), Intellectual Ventures I LLC v. Capital One Bank, 792 F.3d 1363 (Fed. Cir. 2015), and Digitech Image Techs., LLC v. Elecs. for Imaging, Inc., 758 F.3d 1344 (Fed. Cir. 2014). Indeed, “[c]ourts have examined claims that required the use of a computer and still found that the underlying, patent-ineligible invention could be performed via pen and paper or in a person’s mind.” Versata Dev. Grp., Inc. v. SAP Am., Inc., 793 F.3d 1306, 1335 (Fed. Cir. 2015). With respect to Appellant’s arguments under Prong Two, the Examiner responds that: the computer components (one or more databases, a computer program product, a non-transitory storage medium, a processor, Appeal 2021-003319 Application 14/920,327 11 processing system, a computational system, and memory) are recited at a high level of generality and perform the basic functions of a computer (in this case, receiving data, performing calculations, analyzing data, constructing data, and outputting data) that would be needed to apply the abstract idea via computer. Merely using generic computer components to perform the above identified basic computer functions to practice or apply the judicial exception does not constitute a meaningful limitation that would amount to significantly more than the judicial exception, even though such operations could be performed faster than without a computer. In addition, the Examiner respectfully submits that Appellant argues features that have not been claimed such as “data structuring techniques” and that a “vast amount of data” is being sorted and analyzed. Id. We agree with the Examiner. We are not persuaded that “constructing” a feature similarity table, adverse event feature table, and multi-dimensional candidate adverse event table, as a whole, integrates the mental process into a practical application under Prong Two (Appeal Br. 8) at least because those features are part of the abstract idea, which cannot integrate itself into a practical application. The consideration under Prong Two is whether the additional elements recited in the claim integrate the judicial exception into a practical application. 84 Fed. Reg. at 51. As the Examiner observes, the additional elements are recited at a high level of generality and described in the Specification as a generic computer or “processor of a general purpose computer.” Spec. ¶ 68. There are no technical details in the claim as to how these limitations are performed. “Merely claiming ‘those functions in general terms, without limiting them to technical means for performing the functions that are arguably an advance,’ does not make a claim eligible at step one.” Ericsson Inc. v. TCL Commc’n Tech. Holdings Ltd., 955 F.3d 1317, 1328 (Fed. Cir. 2020); SAP, 898 F.3d at 1167-68 (to avoid Appeal 2021-003319 Application 14/920,327 12 ineligibility, a claim must have the specificity that transforms it from one claiming only a result to one claiming a way of achieving the result); Interval Licensing LLC v. AOL, Inc., 896 F.3d 1335, 1346 (Fed. Cir. 2018) (because content data update instructions that enable updating of displayed information are recited only at the broadest, functional level, without any explanation of how that is accomplished, let alone providing a technical means for performing that function, they are not directed to a technological improvement for performing those functions and consist only of generic and conventional information acquisition and organization steps that do not convert the abstract idea into a particular conception of how to carry out that concept); Elec. Power, 830 F.3d at 1356 (noting that the essentially result- focused, functional character of the claim language at issue is a frequent feature of claims that are held to be ineligible under § 101). As a whole, claim 8 does no more than recite instructions and functions in general terms to implement the abstract idea on a generic processor. We next consider whether claim 8 recites additional elements, individually, or as an ordered combination, that provide an inventive concept. Alice, 573 U.S. at 217-18. The second step of the Alice test is satisfied when the claim limitations involve more than performance of well-understood, routine, and conventional activities previously known to the industry. Berkheimer v. HP Inc., 881 F.3d 1360, 1367 (Fed. Cir. 2018). The Examiner finds that claim 8 lacks additional elements that are sufficient to amount to significantly more than the judicial exception. Final Act. 4. The Examiner concludes that as an ordered combination, the additional elements provide no more than when they are considered individually because “nothing in the claims adds significantly more (i.e., an inventive concept) to the abstract idea.” Id. We are not apprised of Appeal 2021-003319 Application 14/920,327 13 Examiner error under Step 2B because Appellant does not advance any arguments to demonstrate that the claim limitations involve more than performance of well-understood, routine, and conventional activities previously known to the industry. Accordingly, we sustain the rejection of claim 8 as directed to an abstract idea without significantly more, and claims 9, 10, 13-18, and 20, which fall with claim 8. Rejection under 35 U.S.C. § 112(b) In the briefs, Appellant does not dispute the rejection of claims 8-10, 13-18, and 20 as indefinite. See Appeal Br. 2. Accordingly, we summarily sustain the rejection under 35 U.S.C. § 112(b). CONCLUSION The Examiner’s rejections are sustained. DECISION SUMMARY In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 8-10, 13- 18, 20 101 Ineligibility 8-10, 13- 18, 20 8-10, 13- 18, 20 112(b) Indefinite 8-10, 13- 18, 20 Overall Outcome 8-10, 13- 18, 20 No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). AFFIRMED