THE S.M.A.R.T. CORPORATIONDownload PDFPatent Trials and Appeals BoardJul 30, 20212020004800 (P.T.A.B. Jul. 30, 2021) 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. 15/223,881 07/29/2016 Gus J. Slotman SLOT0056US.P1 2575 26259 7590 07/30/2021 LICATA & TYRRELL P.C. 66 E. MAIN STREET MARLTON, NJ 08053 EXAMINER BURGESS, JOSEPH D ART UNIT PAPER NUMBER 3626 NOTIFICATION DATE DELIVERY MODE 07/30/2021 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): PTOactions@licataandtyrrell.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte GUS J. SLOTMAN ____________ Appeal 2020-004800 Application 15/223,881 Technology Center 3600 ____________ Before BIBHU R. MOHANTY, NINA L. MEDLOCK, and TARA L. HUTCHINGS, Administrative Patent Judges. HUTCHINGS, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Appellant1 appeals under 35 U.S.C. § 134(a) from the Examiner’s final rejection of claims 1–5 and 7. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. CLAIMED INVENTION The claimed invention uses baseline pre-operative data for an individual patient to predict outcomes for weight, weight loss, and the presence or absence of comorbidities after bariatric surgeries in order to 1 We use the term “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42. Appellant identifies “The S.M.A.R.T. Corporation” as the real party in interest. Appeal Br. 1. Appeal 2020-004800 Application 15/223,881 2 select an appropriate bariatric surgery for a patient. See Spec. ¶ 9; see also id. at 7. Claims 1 and 7 are the independent claims on appeal. Claim 1, reproduced below, is illustrative of the claimed subject matter: 1. A method for selecting a bariatric surgery for a patient, comprising: (a) entering baseline parameters of a patient into a network system comprising a processor that runs one or more statistical tests and compares the baseline parameters of the patient with control profiles comprising independent variables for subjects who have responded positively to bariatric surgeries, wherein the statistical tests comprise generating linear regression models of independent variables for weight and weight loss as dependent variables, and logistic regression models of independent variables for comorbidities as dependent variables, wherein the independent variables comprise at least one of age or employment; (b) generating output from the processor indicating predicted post-operative outcomes for the patient for each of the bariatric surgeries based on the comparison; and (c) selecting a bariatric surgery for the patient. Appeal Br. 21 (Claims Appendix). REJECTIONS Claims 1–5 and 7 are rejected under 35 U.S.C. § 101 as directed to a judicial exception without significantly more. Claims 1, 3–5, and 7 are rejected under 35 U.S.C. § 103 as unpatentable over Harris (WO 2014/047388 A9, pub. Mar. 27, 2014), Maria E. Valera-Mora et al., Predictors of Weight Loss and Reversal of Comorbidities in Malabsorptive Bariatric Surgery, 81 Am. J. Clin. Nutr. 1292–7 (2005) (hereinafter “Valera-Mora”), and Anja Schienkiewitz et al., Comorbidity of Overweight and Obesity in a Nationally Representative Appeal 2020-004800 Application 15/223,881 3 Sample of German Adults Aged 18–79 Years, 12 BMC Public Health (2012) (hereinafter “Schienkiewitz”). Claim 2 is rejected under 35 U.S.C. § 103(a) as unpatentable over Harris, Valera-Mora, Schienkiewitz, and Jensen (US 8,036,912 B2, iss. Oct. 11, 2011). ANALYSIS Patent-Ineligible Subject Matter Principles of Law 35 U.S.C. § 101 An invention is patent eligible if it is a “new and useful process, machine, manufacture, or composition of matter.” 35 U.S.C. § 101. However, the Supreme Court has long interpreted § 101 to include implicit exceptions: “[l]aws of nature, natural phenomena, and abstract ideas are not patentable.” E.g., Alice Corp. v. CLS Bank Int’l, 573 U.S. 208, 216 (2014) (quoting Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 589 (2013)). In determining whether a claim falls within an excluded category, we are guided by the Supreme Court’s two-part framework, described in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. 66 (2012), and Alice, “for distinguishing patents that claim laws of nature, natural phenomena, and abstract ideas from those that claim patent-eligible applications of those concepts.” Alice, 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,” such as an abstract idea. Id. According to Supreme Court precedent, concepts determined to be abstract ideas include certain methods of organizing human activity, such as fundamental economic practices (id. at 219–20; Bilski v. Kappos, 561 U.S. 593, 611 Appeal 2020-004800 Application 15/223,881 4 (2010)); mathematical formulas (Parker v. Flook, 437 U.S. 584, 594–95 (1978)); and mental processes (Gottschalk v. Benson, 409 U.S. 63, 69 (1972)). 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.” Alice, 573 U.S. at 217 (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). USPTO Guidance The U.S. Patent and Trademark Office (“USPTO”) has set out agency policy with respect to its interpretation of Supreme Court and Federal Circuit decisions concerning the requirements for subject matter eligibility. 2019 Revised Patent Subject Matter Eligibility Guidance, 84 Fed. Reg. 50, 51 (Jan. 7, 2019) (“2019 Guidance”); see also October 2019 Update (responding to comments on the 2019 Guidance solicited from the public);2 Berkheimer Memo.3 “The guidance sets out agency policy with respect to 2 October 2019 Update: Subject Matter Eligibility, available at: https://www.uspto.gov/sites/default/files/documents/ peg_oct_2019_update.pdf 3 Memorandum from Robert W. Bahr, Deputy Commissioner for Patent Examination Policy, to the Patent Examining Corps, “Changes in Examination Procedure Pertaining to Subject Matter Eligibility, Recent Subject Matter Decision (Berkheimer v. HP, Inc.)” (April 19, 2018), Appeal 2020-004800 Application 15/223,881 5 the USPTO’s interpretation of the subject matter eligibility requirements of 35 U.S.C. § 101 in view of decisions by the Supreme Court and the Federal Circuit.” 2019 Guidance, 84 Fed. Reg. at 51. However, the “guidance . . . does not create any right or benefit, substantive or procedural, enforceable by any party against the USPTO” and “[r]ejections will continue to be based upon the substantive law.” Id. Because the MANUAL OF PATENT EXAMINATION PROCEDURE §§ 2104–06, Ninth Edition, Rev. 10.2019 (June 2020) (“MPEP”) now incorporates the 2019 Guidance, the October 2019 Update, and the Berkheimer Memo, this opinion refers to the MPEP instead of those materials. The MPEP acknowledges that “[t]he Alice/Mayo two-part test is the only test that should be used to evaluate the eligibility of claims under examination.” MPEP § 2106(I). It treats the first step (i.e., whether the claim is directed to a judicial exception) as a two-prong inquiry. Id. § 2106.04(II). “Prong One asks does the claim recite an abstract idea, law of nature, or natural phenomenon?” Id. § 2106.04(II)(A)(1). For determining whether a claim recites an abstract idea, the MPEP defines enumerated groupings of abstract ideas, distilled from precedent. Id. § 2106.04(a); see also id. § 2106.04(a)(2) (defining abstract idea groupings). If the claim recites a judicial exception, then the claim requires further analysis at Prong Two. Id. § 2106.04(II)(A)(1). “Prong Two asks does the claim recite additional elements that integrate the judicial exception into a practical application?” Id. § 2106.04(II)(A)(2); see also id. § 2106.04(d). Only if a claim (1) recites a judicial exception and (2) does not integrate that available at: https://www.uspto.gov/sites/default/files/documents/memo- berkheimer-20180419.PDF Appeal 2020-004800 Application 15/223,881 6 exception into a practical application, do we then look, under Step 2B, to whether the additional elements, individually or in combination, provide an inventive concept. See MPEP §§ 2106(III), 2106.05. “An inventive concept ‘cannot be furnished by the unpatentable law of nature (or natural phenomenon or abstract idea) itself.’” Id. § 2106.05(I) (quoting Genetic Techs. v. Merial LLC, 818 F.3d 1369, 1376 (Fed. Cir. 2016)). Among the considerations in determining whether the additional elements, individually or in combination, amount to significantly more than the exception itself, we look to whether they add a specific limitation beyond the judicial exception that is not “well-understood, routine, conventional” in the field or simply append well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception. MPEP § 2106.05(II). Rejection The Examiner determines that the claims are directed to selecting a bariatric surgery for a patient based on a comparison of baseline parameters of the patient with control profiles comprising independent variables for subjects who have responded positively to bariatric surgeries. Final Act. 3. The Examiner determines that this concept involves managing personal behavior or relationships or interactions between people, including social activities, teaching, and following rules or instructions, which is a certain method of organizing human activity, i.e., an abstract idea. Id. The Examiner further determines that the claims do not recite additional elements that integrate the abstract idea into a practical application or that amount to significantly more than the abstract idea. Id. at 4–8. Appeal 2020-004800 Application 15/223,881 7 Step One of the Mayo/Alice Framework (2019 Guidance, Step 2A) Appellant argues claims 1–5 and 7 as a group. Appeal Br. 9–14. We select claim 1 as representative. Consequently, claims 2–5 and 7 stand or fall with claim 1. See 37 C.F.R. §41.37(c)(1)(iv). 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 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 a process that itself qualifies as an abstract idea, and not on any improvement to technology and/or a technical field. The Specification is titled “System and Method for Selecting a Bariatric Surgery,” and identifies, in the Background section, health improvements achieved by obese patients who lose weight. Spec. ¶¶ 2–3. Bariatric surgery is a weight loss treatment for qualifying patients, but postoperative complications commonly result. Id. ¶ 5. “Given the risks associated with bariatric surgery, it would be of significant benefit to know the outcome of a bariatric surgery prior to conducting the surgery. The present invention meets this need in the art.” Id. ¶ 6. The inventors found that individual patient weight, weight loss, presence or absence of co-morbidities, and adverse events up to 24 months after open gastric bypass (ORYGP), laparoscopic gastric bypass (LRYGB), adjustable gastric band (AGB), duodenal switch Appeal 2020-004800 Application 15/223,881 8 (DS), and sleeve gastrectomy (SLEEVE) can be predicted from baseline pre-operative data from an individual patient. Using the present invention, demographic, physiologic and medical information about morbidly obese subjects can be entered into the models described herein and surgery outcome can be obtained prior to open gastric bypass, laparoscopic gastric bypass, adjustable gastric banding, sleeve gastrectomy, or duodenal switch surgery. Alternatively stated, using the method of this invention, it can be determined prior to surgery how much weight the subject would lose and whether or not co-morbidities such as sleep apnea, hypertension, diabetes, GERD, and the like will resolve with each of the five operations, thus allowing the subject and the subject’s surgeon to choose objectively which operation would be best for the subject. Id. ¶ 9. Consistent with this disclosure, claim 1 recites a method for selecting a bariatric surgery for a patient comprising three steps: entering baseline parameters of a patient into a . . . system . . . that runs one or more statistical tests and compares the baseline parameters of the patient with control profiles comprising independent variables for subjects who have responded positively to bariatric surgeries, wherein the statistical tests comprise generating linear regression models of independent variables for weight and weight loss as dependent variables, and logistic regression models of independent variables for comorbidities as dependent variables, wherein the independent variables comprise at least one of age or employment; (step (a)); “generating output . . . indicating predicted post-operative outcomes for the patient indicating for each of the bariatric surgeries based on the comparison” (step (b)); and “selecting a bariatric surgery for the patient” (step (c)). These steps, when given their broadest reasonable interpretation, recite a method for selecting a bariatric surgery for a patient. This concept pertains to “managing personal behavior or relationships or interactions Appeal 2020-004800 Application 15/223,881 9 between people (including . . . following rules or instructions),” which is a subgrouping of the “certain methods of organizing human activity” grouping of abstract ideas. See MPEP § 2106.04(a)(2)(II). For example, steps (a) through (c) recite a set of rules or instructions that, when performed, manage an interaction between a patient and surgeon — namely, the selection of a bariatric surgery to be performed on a patient by a surgeon. Appellant does not dispute that claim 1 recites an abstract idea. Instead, Appellant argues that claim 1 is not directed to an abstract idea because it integrates the recited abstract idea into a practical application (Step 2A, Prong Two). Appeal Br. 10–12. Citing McRO, Inc. v. Bandai Namco Games America, Inc., 837 F.3d 1299 (Fed. Cir. 2016) for the proposition that “computing claims are eligible when they are directed to the specific way in which a computer performs a task, even when that overall task is one that humans have done before, such as lip-synching of computer models,” Appellant contends that claim 1, like the patent-eligible claims in McRO, recites a “specific method that improves the relevant technology” of selecting a bariatric surgery for a patient. Appeal Br. 10; see also Reply Br. 2–3. Appellant further asserts that claim 1 “describe[s] a more specific process than merely entering data, conducting a comparison and generating an output.” Appeal Br. 10. Contrary to Appellant’s suggestion, however, the Federal Circuit in McRO did not base its determination that the claimed animation scheme was patent eligible solely on the specificity of the claim language. Instead, the court found that the representative claim was patent eligible because, when looked at as a whole, the claim was directed to a technological improvement over existing, manual 3-D animation techniques by using rules in a process specifically designed to achieve an improved technological result in Appeal 2020-004800 Application 15/223,881 10 conventional industry practice. McRO, 837 F.3d at 1316. In particular, the Federal Circuit found that the claim used limited rules allow computers to produce accurate and realistic lip synchronization and facial expressions in animated characters that previously could only be produced by human animators through a visual and subjective process. Id. at 1313; see also id. at 1306 (describing conventional 3-D computer animation as a visual and subjective process performed manually by human animators using a computer). However, we find no parallel technological improvement in claim 1 analogous to the improvement to 3-D animation techniques obtained in McRO. Appellant concedes that claim 1 does not recite an improvement in “computer technologies” analogous to claims in McRO. Reply Br. 2. Instead, Appellant argues that claim 1 improves the “relevant technology” of “selecting an appropriate bariatric surgery for a patient.” Id. at 2–3; see also Appeal Br. 10–11 (arguing that claim 1 “allow[s] for the selection of a bariatric surgery for a patient by running statistical tests and comparing baseline parameters of a patient with control profiles comprising independent variables for subjects who have responded positively to bariatric surgeries,” thereby “provid[ing] a specific way to determine whether a bariatric surgery is appropriate for a patient”). Yet, selecting an appropriate bariatric surgery pertains to “managing personal behavior or relationships or interactions between people (including . . . following rules or instructions),” which is a subgrouping of the “certain methods of organizing human activity” grouping of abstract ideas. And patent eligibility “cannot be furnished by the unpatentable . . . abstract idea . . . itself.” Genetic Techs., 818 F.3d at 1376. Appeal 2020-004800 Application 15/223,881 11 We are not persuaded by Appellant’s arguments concerning Enfish for similar reasons. In this regard, Appellant maintains that the Federal Circuit in Enfish instructed that “the effect of the claim limitations cannot be discarded in determining the character of the claims as a whole and whether they provide a specific way of performing an abstract idea.” Appeal Br. 11. Appellant asserts that claim 1 is “not directed to ‘any form’ of ‘selecting a bariatric surgery.’” Id. at 12. Instead, claim 1 “provide[s] a specific way of performing an abstract idea” and, thus, is “not directed to a judicial exception.” Id. However, the Federal Circuit in Enfish did not hold that an abstract idea performed in a specific way renders a claim patent eligible. Such a holding would be inconsistent with Supreme Court precedent. See Mayo, 566 U.S. at 88–89 (explaining that “cases have not distinguished among different laws of nature [(or other judicial exceptions)] according to whether or not the principles they embody are sufficiently narrow”). In Enfish the Federal Circuit explained that when determining whether improvements in computer-related technology, including software, are directed to an abstract idea, it is “relevant to ask whether the claims are directed to an improvement to computer functionality versus being directed to an abstract idea.” Enfish, 822 F.3d at 1335. After considering this question, the court concluded that the claims at issue were not focused on a task for which a computer is used in its ordinary capacity. Id. at 1336. Instead, the Federal Circuit found that the “plain focus of the claims” was on an improvement to computer functionality itself — namely, an improvement in computer capabilities achieved by a self-referential table for a computer database. Id.; see also id. at 1339 (finding that the claimed self-referential Appeal 2020-004800 Application 15/223,881 12 table is “designed to improve the way a computer stores and retrieves data in memory”). Here, in contrast, claim 1 is not focused on any improvement to computer functionality itself. Instead, claim 1 focuses on a process that qualifies as an abstract idea (i.e., a method of organizing human activity). The only additional elements recited in claim 1 beyond the abstract idea are a “processor” in a “network system.” The Examiner determines, and we agree, that the additional limitations, considered individually and as a combination, amount to no more than implementing the abstract idea on a computer (i.e., a processor), and generally linking the abstract idea to a particular technological environment (i.e., a network system). Final Act. 4–5. As such, the additional limitations do not integrate the abstract idea into a practical application. See Alice, 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 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 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 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,” i.e., whether the additional elements amount to “significantly more” than the judicial exception itself. MPEP § 2106.05(I). We agree with the Examiner that it does not. Appeal 2020-004800 Application 15/223,881 13 Appellant argues that the additional elements of entering baseline parameters of a patient into a network system comprising a processor, the use of linear regression models of independent variables for weight and weight loss as dependent variables and logistic regression models of independent variables for comorbidities as dependent variables, wherein the independent variables comprise at least one of age or employment, and generating output from the processor indicating predicted post-operative outcomes for the patient for each of the bariatric surgeries based on the comparison recite a specific improvement over prior art approaches for selecting a bariatric surgery for a patient by providing at least 90% predictive specificity for resolution of co- morbidities such as sleep apnea, cholelithiasis, liver disease, congestive heart failure, abdominal hernia and diabetes at 24 months after surgery (Spec., ¶ [0009], ¶ [00040]). Thus, the claimed method recites additional elements that amount to significantly more than the judicial exception. Appeal Br. 12. Appellant additionally argues that the Examiner fails to provide evidentiary support that these additional elements are well- understood routine, and conventional, as required by the Berkheimer Memo. See id. at 12–13. Yet, the relevant question at step two is not whether the claimed invention as a whole is unconventional or non-routine. BSG Tech LLC v. Buyseasons, Inc., 899 F.3d 1281, 1290 (Fed. Cir. 2018). For example, in Alice, the Court did not consider whether it was well-understood, routine, and conventional to execute the claimed intermediated settlement method on a generic computer. See Alice, 573 U.S. at 221–27. Instead, the Court considered the features other than the abstract idea, individually and in combination, to determine whether they contained an “inventive concept” sufficient to transform the abstract idea into a patent-eligible application. Id. at 221; see also id. at 223 (holding that the “mere recitation of a generic Appeal 2020-004800 Application 15/223,881 14 computer cannot transform a patent-ineligible abstract idea into a patent- eligible invention”); Mayo, 566 U.S. at 78 (instructing that after identifying the judicial exception at step one, we ask at step two “[w]hat else is there in the claim before us?”). Here, as described above, other than the abstract idea, claim 1 additionally recites a “processor” in a “network” system. The Examiner determines, and we agree, that “the additional elements are well-understood, routine, and conventional in nature.” Final Act. 5–6 (citing Spec. ¶¶ 26, 27, 30); see also Spec. ¶¶ 7, 8, 26, 30. Appellant does not dispute that these non-abstract features of the claimed invention, considered alone or in combination, are well-understood, routine, or conventional. Nor do we find any inventive concept when the additional elements are considered individually and as an ordered combination. Claim 1 requires no more than using generic functionality of a generic network system and processor— i.e., entering data into a network system comprising a processor (step (a)) and generating output from the processor (step (b)) — to implement the underlying idea. See Alice, 573 U.S. at 221 (holding that generic computer implementation fails to transform an abstract idea into a patent-eligible invention). That the claimed method for selecting a bariatric surgery may be unconventional over prior methods for selecting a bariatric surgery is not relevant as a factual matter. A novel and non-obvious claim directed to a purely abstract idea is, nonetheless, patent ineligible. See Mayo, 566 U.S. at 90; see also Diamond v. Diehr, 450 U.S. 175, 188–89 (1981) (“The ‘novelty’ of any element or steps in a process, or even of the process itself, is of no relevance in determining whether the subject matter of a claim falls within the § 101 categories of possibly patentable subject matter.”). Appeal 2020-004800 Application 15/223,881 15 Accordingly, 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 under 35 U.S.C. § 101 of claim 1 and claims 2–5 and 7, which fall with claim 1. Obviousness Independent Claims 1 and 7, and Dependent Claims 3–5 We are persuaded that the Examiner erred in rejecting independent claims 1 and 7 under 35 U.S.C. § 103 because Schienkiewitz does not teach or suggest run[ning] one or more statistical tests and compar[ing] the baseline parameters of the patient with control profiles comprising independent variables for subjects who have responded positively to bariatric surgeries, wherein the statistical tests comprise generating . . . logistic regression models of independent variables for comorbidities as dependent variables, wherein the independent variables comprise at least one of age or employment[,] as recited in claim 1, limitation (a), and similarly recited in claim 7. The Examiner finds that Harris teaches entering baseline parameters of a patient into a network system comprising a processor that: runs one or more statistical tests, and compares the baseline parameters of the patient profile with control profiles comprising independent variables for subjects who have responded positively to bariatric surgeries. Final Act. 8–9 (citing Harris ¶¶ 7, 160, Fig. 1). Harris relates to predicting outcomes for bariatric surgery. Harris ¶ 7. Harris’s system includes a patient data input module and an outcome prediction module. Id. The patient data input module receives patient data, such as patient age, weight, and health issues other than obesity, from a client terminal. Id. ¶¶ 7, 129. The outcome prediction module receives the patient data, and predicts an outcome for each of a Appeal 2020-004800 Application 15/223,881 16 plurality of bariatric surgery procedures based on the received patient data and historical data regarding outcomes of the plurality of bariatric surgery procedures. Id.; see also id. ¶¶ 130, 160. More specifically, the output prediction module has a model for each bariatric surgical procedure. Id. ¶ 160. The model includes an equation with coefficients based on historical data. Id. Patient data are plugged into the equation’s input variables to predict an output for the bariatric surgical procedure. Id. Exemplary models include multivariable models, such as multivariable regression models, that base variable selection based on a variety of statistical measures. Id. The outcome from the outcome prediction module includes an amount of BMI reduction and/or an amount of weight loss. Id. ¶ 7. The Examiner acknowledges that Harris does not teach that the statistical tests comprise “logistic regression models of independent variables for comorbidities as dependent variables, wherein the independent variables comprise at least one of age or employment,” as recited in claim 1, limitation (a), and similarly recited in claim 7. However, the Examiner finds that Schienkiewitz teaches “logistic models using chronic health conditions, interpreted as comorbities, as dependent variables” and using age as an independent variable. Final Act. 9–10 (citing Schienkiewitz, Abstract, 2–3). Schienkiewitz relates to determining comorbidities associated with overweight and obesity in a study of German adults. Schienkiewitz Abstract, 2. The study involved interviewing participants to assess disease, health problems and current medication used, using information from twenty five chronic health problems. Id. at 2. The study also used a questionnaire to gather information on covariates, such as age, smoking habits, education, and professional status. Id. To assess for a comorbidity, the study fitted a separate multivariate logistic model for each Appeal 2020-004800 Application 15/223,881 17 health condition or comorbidity (dependent variable) and for overweight, obesity, or abdominal obesity (independent variable), adjusting for covariates. Id. at 3. Specifically, the study adjusted the models for age, social status, and drinking. Id. at Abstract, 3. For example, “[a]fter adjustment for age, social status, and smoking, both overweight and obesity were significantly associated with cardiometabolic risk factors and osteoarthritis in men and women (Table 3).” Id. at 4, Table 3. The Examiner determines that it would have been obvious to combine Harris and Schienkiewitz to identify comorbidities associated with overweight and obesity. Final Act. 10 (citing Schienkiewitz, Abstract). Yet, claims 1 and 7 require that the statistical tests generate logistic regression models of independent variables for subjects who have responded positively to bariatric surgeries, wherein at least one of the independent variables is age or employment. Although Harris involves predicting weight loss for each of a plurality of bariatric surgeries based on patient data and historical data regarding outcomes for the respective bariatric surgeries, Harris does not predict resolution of comorbidities. Schienkiewitz uses multivariate logistic models to identify comorbidities associated with overweight and obesity. However, Schienkiewitz does not concern predicting resolution of comorbidities as an outcome for bariatric surgeries. Accordingly, Schienkiewitz’s logistic regression models do not comprise independent variables for subjects who have responded positively to bariatric surgeries, as required by independent claims 1 and 7. It is unclear, and the Examiner does not adequately explain, why or how one of ordinary skill in the art would be motivated to combine Harris and Schienkiewitz in a manner to result in the claimed invention. For example, because Schienkiewitz identifies particular comorbidities Appeal 2020-004800 Application 15/223,881 18 associated with overweight and obesity, Schienkiewitz in combination with Harris may suggest to one of ordinary skill in the art that the bariatric surgery that predicts the largest amount of weight loss via the claimed linear regression models would also offer the most likely resolution of a comorbidity when there is an association between the comorbidity and overweight/obesity. That is, there is no apparent reason that one of ordinary skill in the art would be motivated to modify Harris to generate the claimed logistic regression model, particularly given that Schienkiewitz does not teach the claimed regression model comprising independent variables for subjects who have responded positively to bariatric surgeries. We also agree with Appellant that Schienkiewitz does not teach or suggest that at least one of age or employment is an independent variable of the logistic regression model, as required by claim 1, limitation (a) and claim 7. Schienkiewitz teaches adjusting the model based on age, but not using age as an independent variable. See Schienkiewitz Abstract, 3, 4, Table 3. Accordingly, we do not sustain the Examiner’s rejection of independent claims 1 and 7, and dependent claims 3–5, under 35 U.S.C. § 103 as unpatentable over Harris, Valera-Mora, and Schienkiewitz. Dependent Claim 2 The Examiner’s rejection of dependent claim 2 under 35 U.S.C. § 103 as unpatentable over Harris, Valera-Mora, Schienkiewitz, and Jensen does not cure the deficiency in the Examiner’s rejection of independent claim 1 under 35 U.S.C. § 103 as unpatentable over Harris, Valera-Mora, and Schienkiewitz. Therefore, we do not sustain the Examiner’s rejection of claim 2 under 35 U.S.C. § 103 for the same reasons set forth above. Appeal 2020-004800 Application 15/223,881 19 CONCLUSION In summary: Claim(s) Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1–5, 7 101 Eligibility 1–5, 7 1, 3–5, 7 103 Harris, Valera- Mora, Schienkiewitz 1, 3–5, 7 2 103 Harris, Valera- Mora, Schienkiewitz, Jensen 2 Overall Outcome 1–5, 7 Because we have affirmed at least one ground of rejection with respect to each claim on appeal, the Examiner’s decision is affirmed. See 37 C.F.R. § 41.50(a)(l). 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). AFFIRMED Copy with citationCopy as parenthetical citation