Parkland Center for Clinical InnovationDownload PDFPatent Trials and Appeals BoardNov 19, 20202020004556 (P.T.A.B. Nov. 19, 2020) Copy Citation 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. 14/326,863 07/09/2014 Rubendran Amarasingham PCCI-P0012US-NP 8117 134449 7590 11/19/2020 Grable Martin Fulton PLLC 2709 Dublin Road Plano, TX 75094 EXAMINER MOSELEY, GREGORY D ART UNIT PAPER NUMBER 3686 NOTIFICATION DATE DELIVERY MODE 11/19/2020 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): docketing@gchub.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte RUBENDRAN AMARASINGHAM, VAIDYANATHA SIVA, MONAL SHAH, ANAND SHAH, GEORGE OLIVER, PRASEETHA CHERIAN, JAVIER VELAZQUEZ, and PAUL MAYER III ____________ Appeal 2020-004556 Application 14/326,863 Technology Center 3600 ____________ Before MURRIEL E. CRAWFORD, NINA L. MEDLOCK, and AMEE A. SHAH, Administrative Patent Judges. MEDLOCK, Administrative Patent Judge. DECISION ON APPEAL Appeal 2020-004556 Application 14/326,863 2 STATEMENT OF THE CASE Appellant1 appeals under 35 U.S.C. § 134(a) from the Examiner’s final rejection of claims 1–4, 6, 8, 10, 11, 13, 15–34, 36, 37, 39, and 41–54. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. CLAIMED INVENTION The claimed invention “generally relates to a healthcare system, and more particularly . . . to a patient care surveillance system and method” (Spec. ¶ 2). Claims 1, 28, and 54 are the independent claims on appeal. Claim 1, reproduced below with bracketed notations added, is illustrative of the claimed subject matter: 1. A patient care surveillance system, comprising: [(a)] a data store operable to receive and store clinical and non-clinical data associated with a plurality of patients, the clinical and non-clinical data being selected from the group consisting of: past medical history, age, weight, height, race, gender, marital status, education, address, housing status, allergy and adverse medical reactions, family medical information, prior surgical information, emergency room records, medication administration records, culture results, clinical notes and records, gynecological and obstetric information, mental status examination, vaccination records, radiological imaging exams, 1 We use the term “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42. Our decision references Appellant’s Appeal Brief (“Appeal Br.,” filed December 2, 2019) and the Examiner’s Answer (“Ans.,” mailed February 5, 2020), Advisory Action (“Adv. Act.,” mailed August 30, 2019), and Final Office Action (“Final Act.,” mailed May 20, 2019). Appellant identifies Dallas County Hospital District, a political subdivision of the State of Texas, d/b/a Parkland Health & Hospital System, as the real party in interest (Appeal Br. 1). Appeal 2020-004556 Application 14/326,863 3 invasive visualization procedures, psychiatric treatment information, prior histological specimens, laboratory results, genetic information, socio-economic status, type and nature of employment, job history, lifestyle, hospital utilization patterns, addictive substance use, frequency of physician or health system contact, location and frequency of habitation changes, census and demographic data, neighborhood environments, diet, proximity and number of family or care-giving assistants, travel history, social media data, social workers’ notes, pharmaceutical and supplement intake information, focused genotype testing, medical insurance information, exercise information, occupational chemical exposure records, predictive screening health questionnaires, personality tests, census and demographic data, neighborhood environment data, and participation in food, housing, and utilities assistance registries; [(b)] a user interface configured to receive user input of current information related to the plurality of patients; [(c)] a monitor configured to sense at least one parameter associated with the plurality of patients and further configured to generate real-time patient monitor data including sensed locations of the plurality of patients; [(d)] a data analysis module configured to access the data store, preprocess the data using natural language processing, and analyze the clinical and non-clinical data, receive and analyze the current information and real-time patient monitor data, and identify at least one adverse event associated with the care of the plurality of patients, the data analysis module being configured to apply at least one predictive model to the clinical and non- clinical data in consideration of a plurality of weighted risk variables and risk thresholds to identify the at least one adverse event, and ranking the plurality of patients in response to each patient’s risk associated with the at least one adverse event; and [(e)] a data presentation module operable to present information associated with the identified at least one adverse event associated with the care of the plurality of patients according to the ranking to a healthcare professional. Appeal 2020-004556 Application 14/326,863 4 REJECTIONS Claims 1–4, 6, 8, 10, 11, 13, 15–34, 36, 37, 39, and 41–54 are rejected under 35 U.S.C. § 101 as directed to a judicial exception without significantly more. Claims 1, 2, 4, 6, 8, 10, 11, 13, 15, 16, 23–25, 28, 29, 31–34, 36, 37, 39, 41, 42, 48–50, 53, and 54 are rejected under 35 U.S.C. § 103 as unpatentable over Rosenfeld et al. (US 2006/0271408 A1, published Nov. 30, 2006) (“Rosenfeld”), Rao et al. (US 7,617,078 B2, issued Nov. 10, 2009) (“Rao”), Sharbaugh (US 2008/0106374 A1, published May 8, 2008), and Magent et al. (US 2010/0131434 A1, published May 27, 2010) (“Magent”). Claims 3 and 30 are rejected under 35 U.S.C. § 103 as unpatentable over Rosenfeld, Rao, Sharbaugh, Magent, and Ryan et al. (US 2012/0046965 A1, published Feb. 23, 2012) (“Ryan”). Claims 17–22 and 43–47 are rejected under 35 U.S.C. § 103 as unpatentable over Rosenfeld, Rao, Sharbaugh, Magent, and Hume et al. (US 2013/0047113 A1, published Feb. 21, 2013) (“Hume”). Claims 26, 27, 51, and 52 are rejected under 35 U.S.C. § 103 as unpatentable over Rosenfeld, Rao, Sharbaugh, Magent, and Ober et al. (US 2007/0185739 A1, published Aug. 9, 2007) (“Ober”). ANALYSIS Patent-Ineligible Subject Matter Appellant argues the pending claims as a group (Appeal Br. 19–21). We select independent claim 1 as representative of the group. The remaining claims stand or fall with claim 1, see 37 C.F.R. §41.37(c)(1)(iv), Appeal 2020-004556 Application 14/326,863 5 except we also consider Appellant’s separate assertions with respect to dependent claims 2–4, 6, 8, 10, 11, 13, 15–27 (Appeal Br. 21). Under 35 U.S.C. § 101, a claim 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 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 79, 78). 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). The U.S. Patent and Trademark Office (the “USPTO”) published revised guidance on January 7, 2019 for use by USPTO personnel in Appeal 2020-004556 Application 14/326,863 6 evaluating subject matter eligibility under 35 U.S.C. § 101. 2019 REVISED PATENT SUBJECT MATTER ELIGIBILITY GUIDANCE, 84 Fed. Reg. 50, 57 (Jan. 7, 2019) (the “2019 Revised Guidance”).2 That guidance revised the USPTO’s examination procedure with respect to the first step of the Mayo/Alice framework by (1) “[p]roviding groupings of subject matter that [are] considered an abstract idea”; and (2) clarifying that a claim is not “directed to” a judicial exception if the judicial exception is integrated into a practical application of that exception. Id. at 50. The first step, as set forth in the 2019 Revised Guidance (i.e., Step 2A), is, thus, a two-prong test. In Step 2A, Prong One, we look to whether the claim recites a judicial exception, e.g., one of the following three groupings of abstract ideas: (1) mathematical concepts; (2) certain methods of organizing human activity, e.g., fundamental economic principles or practices, commercial or legal interactions; and (3) mental processes. 2019 Revised Guidance, 84 Fed. Reg. at 54. If so, we next determine, in Step 2A, Prong Two, whether the claim as a whole integrates the recited judicial exception into a practical application, i.e., whether the additional elements recited in the claim beyond the judicial exception, 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. Id. at 54–55. Only if the claim (1) recites a judicial exception and (2) does not integrate that 2 The USPTO issued an update on October 17, 2019 (the “October 2019 Update: Subject Matter Eligibility,” available at https://www.uspto.gov/sites/ default/files/documents/peg_oct_2019_update.pdf) clarifying the 2019 Revised Guidance in response to public comments. Appeal 2020-004556 Application 14/326,863 7 exception into a practical application do we conclude that the claim is “directed to” the judicial exception, e.g., an abstract idea. Id. If the claim is determined to be directed to a judicial exception under revised Step 2A, we next evaluate the additional elements, individually and in combination, in Step 2B, to determine whether they provide an inventive concept, i.e., whether the additional elements or combination of elements amounts to significantly more than the judicial exception itself. Only then, is the claim patent eligible. 2019 Revised Guidance, 84 Fed. Reg. at 56. Here, the Examiner determined that independent claims 1, 28, and 54 recite “remote patient monitoring and notifying providers in case of an adverse event,” i.e., a mental process, and, therefore an abstract idea (Final Act. 4–5), and that the abstract idea is not integrated into a practical application (id. at 5). The Examiner also determined that claims 1, 28, and 54 do not include additional elements sufficient to amount to significantly more than the abstract idea itself (id. at 5–10), and that the dependent claims are patent ineligible for substantially similar reasons (id. at 11–12). Step One of the Mayo/Alice Framework (2019 Revised Guidance, Step 2A) We are not persuaded by Appellant’s argument that the Examiner erred in determining that claim 1 is directed to an abstract idea (Appeal Br. 11–18, 22–24). The Federal Circuit has explained that “the ‘directed to’ inquiry applies a stage-one filter to claims, considered in light of the specification, based on whether ‘their character as a whole is directed to excluded subject matter.’” Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1335 (Fed. Cir. 2016) (quoting Internet Patents Corp. v. Active Network, Inc., 790 F.3d 1343, 1346 (Fed. Cir. 2015)). It asks whether the focus of the claims is on a specific improvement in relevant technology or on a process Appeal 2020-004556 Application 14/326,863 8 that itself qualifies as an “abstract idea” for which computers are invoked merely as a tool. See id. at 1335–36. Here, it is clear from the Specification (including the claim language) that claim 1 focuses on an abstract idea, and not on any improvement to technology and/or a technical field. The Specification is titled “PATIENT CARE SURVEILLANCE SYSTEM AND METHOD,” and describes, in the Background section, that “[c]onventionally, hospitals and healthcare facilities rely on voluntary incident reporting and retrospective manual record reviews to identify and track adverse events” (Spec. ¶ 3).3 However, the Specification describes that these efforts have been largely unreliable, fail to capture all relevant data, and do not present an accurate and timely picture of patient care (id.). In addition, because of the voluntary nature of incident reporting, many adverse events are never reported (id.). The claimed invention is intended to provide a patient care surveillance system and method that improves patient care by capturing and analyzing relevant information surrounding and relating to the occurrence of adverse events on a real-time basis (Spec. ¶ 8). Claim 1, thus, recites a patient care surveillance system comprising: (1) a data store for receiving and storing patient clinical and non-clinical data, i.e., a data store operable to receive and store clinical and non- clinical data associated with a plurality of patients, the clinical and non-clinical data being selected from the group consisting of: past medical history, age, weight, height, race, gender, marital status, education, address, housing status, allergy and adverse medical reactions, family medical information, prior surgical 3 “An adverse event is typically defined as unintended injury to a patient resulting from or contributing to medical care that requires additional monitoring, treatment, or hospitalization, or that results in death” (id.). Appeal 2020-004556 Application 14/326,863 9 information, emergency room records, medication administration records, culture results, clinical notes and records, gynecological and obstetric information, mental status examination, vaccination records, radiological imaging exams, invasive visualization procedures, psychiatric treatment information, prior histological specimens, laboratory results, genetic information, socio-economic status, type and nature of employment, job history, lifestyle, hospital utilization patterns, addictive substance use, frequency of physician or health system contact, location and frequency of habitation changes, census and demographic data, neighborhood environments, diet, proximity and number of family or care-giving assistants, travel history, social media data, social workers’ notes, pharmaceutical and supplement intake information, focused genotype testing, medical insurance information, exercise information, occupational chemical exposure records, predictive screening health questionnaires, personality tests, census and demographic data, neighborhood environment data, and participation in food, housing, and utilities assistance registries (limitation (a)); (2) “a user interface configured to receive user input of current information related to the plurality of patients” (limitation (b)); (3) “a monitor configured to sense at least one parameter associated with the plurality of patients and further configured to generate real-time patient monitor data including sensed locations of the plurality of patients” (limitation (c)); (4) a data analysis module configured to access and analyze the clinical and non-clinical data, receive and analyze the current information and real-time patient monitor data, and identify at least one adverse event associated with the care of the plurality of patients, i.e., a data analysis module configured to access the data store, preprocess the data using natural language processing, and analyze the clinical and non-clinical data, receive and analyze the current information and real-time patient monitor data, and identify at least one adverse event associated with the care of the plurality of patients, the data analysis module being configured Appeal 2020-004556 Application 14/326,863 10 to apply at least one predictive model to the clinical and non- clinical data in consideration of a plurality of weighted risk variables and risk thresholds to identify the at least one adverse event, and ranking the plurality of patients in response to each patient’s risk associated with the at least one adverse event (limitation (d)); and (5) a data presentation module operable to present information regarding the one or more adverse events to a healthcare professional, i.e., “a data presentation module operable to present information associated with the identified at least one adverse event associated with the care of the plurality of patients according to the ranking to a healthcare professional” (limitation (e)). Appellant notes that “[t]he 2019 PEG explicitly indicated that ‘the ‘mental processes’ grouping is defined as concepts performed in the human mind, and examples of mental processes include observation, evaluation, judgment, and opinion’” (Appeal Br. 19). And Appellant argues that claim 1 is not directed to an abstract idea because the claim contains limitations that cannot practically be performed in the human mind (id. at 19–20). Specifically referencing limitations (b) and (c) of claim 1, Appellant argues that “the human mind does not and cannot include ‘a user interface configured to receive user input of current information related to the plurality of patients’; or ‘a monitor configured to sense at least one parameter associated with the plurality of patients and further configured to generate real-time patient monitor data including sensed locations of the plurality of patients’” (Appeal Br. 19–20). Appellant also contends that the human mind, although capable of receiving and analyzing information, “does not and cannot include ‘a data analysis module[, as recited in limitation (d) of claim 1,] configured to access the data store, preprocess the data using natural language processing, and analyze the clinical and non- Appeal 2020-004556 Application 14/326,863 11 clinical data, receive and analyze the current information and real-time patient monitor data, and identify at least one adverse event associated with the care of the plurality of patients” (id.). Claim 1 admittedly recites that the claimed system comprises certain tangible components. Yet, we agree with the Examiner that the underlying functions are all acts that could be performed in the human mind (Final Act. 4–5). Indeed, we find nothing in claim language that forecloses the claimed functions set forth in limitations (b), (c), and (d) from being performed by a human, mentally or with pen and paper. Limitation (b), for example, requires receiving user input of current patient information — something that a person plainly could perform in his or her mind or using pen and paper. A person also could monitor and record patient movement, as well as changes in the patient’s vital signs, either mentally or using pen and paper, and could receive and analyze information (including clinical and non-clinical data, current patient information, and real-time patient monitor data) and identify adverse patient events, again either mentally or using pen and paper. Such a person also could report any adverse events to a healthcare professional, either orally or via written communication. Cf. Clarilogic, Inc. v. FormFree Holdings Corp., 681 F. App’x 950 (Fed. Cir. 2018) (holding ineligible a claimed method for providing certified financial data indicating financial risk about an individual where a computer generated a report from the financial account data including real-time and historical transaction and balance data as directed to the abstract idea of collecting information, analyzing it, and displaying certain results of the collection and analysis). Appeal 2020-004556 Application 14/326,863 12 In sum, we agree with the Examiner that claim 1 recites a mental process, i.e., a concept performed in the human mind, including an observation, evaluation, or judgment, and therefore, an abstract idea. See 2019 Revised Guidance, 84 Fed. Reg. at 52; CyberSource Corp. v. Retail Decisions, Inc., 654 F.3d 1366, 1373 (Fed. Cir. 2011) (holding that method steps that can be performed in the human mind, or by a human using a pen and paper, are unpatentable mental processes). See also Elec. Power Grp., LLC v. Alstom, S.A., 830 F.3d 1350, 1355 (Fed. Cir. 2016) (explaining that the Federal Circuit treats “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”); Intellectual Ventures I LLC v. Symantec Corp., 838 F.3d 1307, 1308 (Fed. Circ. 2016) (“[W]ith the exception of generic computer-implemented steps, there is nothing in the claims themselves that foreclose[s] them from being performed by a human, mentally or with pen and paper.”); Versata Dev. Grp., Inc. v. SAP Am., Inc., 793 F.3d 1306, 1335 (Fed. Cir. 2015) (“Courts 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.”). Separately addressing dependent claims 2–4, 6, 8, 10, 11, 13, 15–27, Appellant notes that (1) dependent claims 2–4, 6, 8, and 23–27 recite further limitations of the data analysis module; (2) claim 10 recites a user interface; (3) claims 11, 13, and 15 recite further limitations of the monitor; (4) claims 16–21 recite further limitations of the data presentation module; and (5) claim 22 recites a plurality of databases (Appeal Br. 21). Appellant summarily asserts that none of these limitations is a mental process (id.). Appeal 2020-004556 Application 14/326,863 13 But, in the absence of any further explanation, we are not persuaded that the Examiner erred in determining that these dependent claims recite mental processes. Having concluded that claim 1 recites a judicial exception, i.e., an abstract idea (Step 2A, Prong One), we next consider whether the claim recites additional elements that integrate the judicial exception into a practical application (Step 2A, Prong Two). The only additional elements recited in claim 1, beyond the abstract idea, are “a data store”; “a user interface”; “a monitor”; “a data analysis module”; and “a data presentation module” —elements recited at a high level of generality, and described in the Specification as generic computer and/or “off the shelf” components (see, e.g., Spec. ¶¶ 9, 13, 16–18, 82, 85, 86).4 We find no indication in the Specification, nor does Appellant direct us to any indication, that the operations recited in claim 1 invoke any allegedly inventive programming, require any specialized computer hardware or other inventive computer components, i.e., a particular machine, or that the claimed invention is implemented using other than generic computer components to perform generic computer functions. See DDR Holdings, LLC v. Hotels.com, L.P., 773 F.3d 1245, 1256 (Fed. Cir. 2014) (“[A]fter Alice, there can remain no doubt: recitation of generic computer limitations does not make an otherwise ineligible claim patent-eligible.”). 4 The Examiner determined, and Appellant ostensibly agreed, that the “data analysis module” and “data presentation module” limitations are properly regarded as “means-plus-function” limitations and, thus, properly construed in accordance with 35 U.S.C. 112(f) to encompass the corresponding structure disclosed in the Specification and equivalents thereof. Appeal 2020-004556 Application 14/326,863 14 We also find no indication in the Specification that the claimed invention effects a transformation or reduction of a particular article to a different state or thing. Nor do we find anything of record that attributes an improvement in technology and/or a technical field to the claimed invention or that otherwise indicates that the claimed invention integrates the abstract idea into a “practical application,” as that phrase is used in the 2019 Revised Guidance.5 Appellant argues that “the claims recite additional elements that provide for a specific manner of surveilling patients in an efficient manner in response to an analysis of clinical and non-clinical data of the patients to determine the risk levels of the patients for adverse events, including the use of a predictive model” and that “[t]he result is an improved system that enables a more efficient focus of the attention and resources to the most at-risk patients” (Appeal Br. 21). But, we are not persuaded that enabling a more efficient focus of attention and resources to the most at-risk patients by surveilling patients in response to an analysis of clinical and non-clinical 5 The 2019 Revised Guidance references MANUAL OF PATENT EXAMINING PROCEDURE, Ninth Edition (rev. Jan 2018) (available at https://mpep.uspto.gov/RDMS/MPEP/E9_R-08.2017.) § 2106.05(a)–(c) and (e) in non-exhaustively listing considerations indicative that an additional element or combination of elements may have integrated the recited judicial exception into a practical application. 2019 Revised Guidance, 84 Fed. Reg. at 55. The Guidance, thus, describes that an additional element may have integrated the judicial exception into a practical application if, for example, the additional element (1) reflects an improvement in the functioning of a computer or an improvement to other technology or technical field; (2) implements the judicial exception with, or uses the judicial exception with, a particular machine or manufacture integral to the claim; or (3) effects a transformation or reduction of an article to a different state or thing. 2019 Revised Guidance, 84 Fed. Reg. at 55. Appeal 2020-004556 Application 14/326,863 15 data is a technological improvement, as opposed to an improvement to the abstract idea of monitoring patients and reporting the occurrence of adverse events. See SAP Am., Inc. v. InvestPic, LLC, 898 F.3d 1161, 1170 (Fed. Cir. 2018) (“[P]atent law does not protect such claims [i.e., claims to an asserted advance in the realm of abstract ideas], without more, no matter how groundbreaking the advance.”). Considered in light of the Specification, the claimed invention clearly focuses on improving the quality of patient care by monitoring, quantifying, and reporting the occurrence of adverse events on a real-time basis (see, e.g., Spec. ¶ 3 (describing that past efforts to identify and track adverse events “have been largely unreliable, fail to capture all relevant data and do not present an accurate and timely picture of patient care”); ¶ 8 (describing that “[b]y capturing and analyzing relevant information surrounding and relating to the occurrence of adverse events on a real-time basis, policies and procedures may be implemented to improve patient care and may result in significantly better outcomes”)), and not on any claimed means for achieving that goal that improves technology. We conclude, for the reasons outlined above, that claim 1 recites a mental process, i.e., an abstract idea, and that the additional elements recited in the claim beyond the abstract idea, are no more than generic computer and off-the-shelf components used as tools to perform the recited abstract idea (see, e.g., Spec. 20:20–22:7). As such, they do not integrate the abstract idea into a practical application. See Alice Corp., 573 U.S. at 223–24 (“[W]holly generic computer implementation is not generally the sort of ‘additional featur[e]’ that provides any ‘practical assurance that the process is more than a drafting effort designed to monopolize the [abstract idea] itself.’” (quoting Appeal 2020-004556 Application 14/326,863 16 Mayo, 566 U.S. at 77)). Accordingly, we agree with the Examiner that claim 1 is directed to an abstract idea. Step Two of the Mayo/Alice Framework (2019 Revised Guidance, Step 2B) Having determined under step one of the Mayo/Alice framework that claim 1 is directed to an abstract idea, we next consider under Step 2B of the 2019 Revised Guidance, the second step of the Mayo/Alice framework, whether claim 1 includes additional elements or a combination of elements that provides an “inventive concept.” 2019 Revised Guidance, 84 Fed. Reg. at 56. We conclude that it does not. And Appellant offers no argument to the contrary. We are not persuaded, on the present record, that the Examiner erred in rejecting independent claim 1 under 35 U.S.C. § 101. Therefore, we sustain the Examiner’s rejection of claim 1, and of claims 2–4, 6, 8, 10, 11, 13, 15–34, 36, 37, 39, and 41–54, which fall with claim 1. Obviousness Independent Claim 1 and Dependent Claims 2, 4, 6, 8, 10, 11, 13, 15, 16, and 23–25 Appellant argues that the Examiner erred in rejecting independent claim 1 under 35 U.S.C. § 103 at least because Sharbaugh, on which the Examiner relies, fails to disclose or suggest “a monitor . . . configured to generate real-time patient monitor data including sensed locations of the plurality of patients,” as recited in claim 1 (Appeal Br. 22). Sharbaugh is directed to a patient room information system, and discloses a point of care apparatus including an identification system for automatically identifying persons or objects in a patient’s room (Sharbaugh ¶ 10). In one embodiment, an ultrasonic identification system includes tags Appeal 2020-004556 Application 14/326,863 17 worn by the patient, family member and/or caregiver, or attached to equipment, each of which emits a unique series of sounds that are detected by a sensor located in the room (id. ¶ 11). Sharbaugh discloses, in paragraph 33, cited by the Examiner, that one or more identification signal readers could be positioned in the room to allow the system to “sense the presence of a tag in the space and/or allow triangulation through multiple sensors to assess a more specific location of a tag in the room.” Sharbaugh describes, “[f]or example, the system could determine when a patient gets out of the bed” (id. ¶ 33). Appellant acknowledges that Sharbaugh “appears to disclose” using RFID technology to sense the presence of the patient and others in a patient room (Appeal Br. 22). But, Appellant argues that Sharbaugh does not disclose monitoring for the “sensed locations of the plurality of patients” because “Sharbaugh only detects where the patient is located inside the patient’s room and nowhere else” (id.). Responding to Appellant’s argument, the Examiner opines that “[t]here is no language in the claims that requires the system to be able to monitor the patient’s location outside of [his or her] room or that the patient’s location is ‘tracked’” (Ans. 6). And the Examiner concludes that “[t]he ability to receive information including the location of a patient at a critical care location is within the broadest reasonable interpretation of the claims” (id.). Appellant has not filed a Reply Brief or otherwise explained why the Examiner’s position is unreasonable or unsupported. Appellant also argues that the obviousness rejection of claim 1 cannot be sustained because none of the cited references discloses or suggests Appeal 2020-004556 Application 14/326,863 18 a data analysis module configured to access the data store, preprocess the data using natural language processing, and analyze the clinical and non-clinical data, receive and analyze the current information and real-time patient monitor data, and identify at least one adverse event associated with the care of the plurality of patients, the data analysis module being configured to apply at least one predictive model to the clinical and non- clinical data in consideration of a plurality of weighted risk variables and risk thresholds to identify the at least one adverse event, and ranking the plurality of patients in response to each patient’s risk associated with the at least one adverse event[,] i.e., limitation (d), as recited in claim 1 (Appeal Br. 24–25). Addressing Rosenfeld, on which the Examiner relies,6 Appellant notes that “Rosenfeld teaches a system that generates rules and decides whether the rule should be revised based on performance measures” (Appeal Br. 22–23 (citing Rosenfeld ¶ 32))). And Appellant summarily asserts, without any further explanation, that “[a] rule-based system is not a predictive model required in claim 1” (id. at 23). In the absence of additional arguments or technical reasoning, we are not persuaded that the Examiner erred in rejecting claim 1 under 35 U.S.C. § 103. Therefore, we sustain the Examiner’s rejection of claim 1. We also sustain the Examiner’s rejection of dependent claims 2, 4, 6, 8, 10, 11, 13, 15, 16, and 23–25, which are not argued separately. 6 The Examiner cites paragraphs 32, 67, 69, 74, 75, 79, 81, 103, and 104 of Rosenfeld as disclosing the argued limitation (Final Act. 18–21). Appeal 2020-004556 Application 14/326,863 19 Independent Claim 28 and Dependent Claims 28, 29, 31–34, 36, 37, 39, 41, 42, 48–50, and 53 Appellant’s arguments with respect to independent claim 28 are substantially similar to Appellant’s arguments with respect to claim 1, and are similarly insufficient to establish Examiner error. We are not persuaded on the present record that the Examiner erred in rejecting claim 28 under 35 U.S.C. § 103. Therefore, we sustain the Examiner’s rejection of independent claim 28, and dependent claims 28, 29, 31–34, 36, 37, 39, 41, 42, 48–50, and 53, which are not argued separately. Independent Claim 54 and Dependent Claims 3, 17–22, 26, 27, 30, 43–47, 51, and 52 Appellant does not provide any response to the Examiner’s rejections under 35 U.S.C. § 103 of claims 3, 17–22, 26, 27, 30, 43–47, 51, 52, and 54. Therefore, we summarily sustain the Examiner’s rejections of these claims. CONCLUSION In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1–4, 6, 8, 10, 11, 13, 15–34, 36, 37, 39, 41–54 101 Eligibility 1–4, 6, 8, 10, 11, 13, 15–34, 36, 37, 39, 41–54 Appeal 2020-004556 Application 14/326,863 20 Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1, 2, 4, 6, 8, 10, 11, 13, 15, 16, 23–25, 28, 29, 31–34, 36, 37, 39, 41, 42, 48–50, 53, 54 103 Rosenfeld, Rao, Sharbaugh, Magent 1, 2, 4, 6, 8, 10, 11, 13, 15, 16, 23–25, 28, 29, 31–34, 36, 37, 39, 41, 42, 48–50, 53, 54 3, 30 103 Rosenfeld, Rao, Sharbaugh, Magent, Ryan 3, 30 17–22, 43–47 103 Rosenfeld, Rao, Sharbaugh, Magent, Hume 17–22, 43–47 26, 27, 51, 52 103 Rosenfeld, Rao, Sharbaugh, Magent, Ober 26, 27, 51, 52 Overall Outcome 1–4, 6, 8, 10, 11, 13, 15–34, 36, 37, 39, 41–54 No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R. § 1.136(a)(1)(iv). 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