STICHTING KATHOLIEKE UNIVERSITEIT, MORE PARTICULA- RLY THE FACULTY OF SCIENCE OF RADBOUD UNIVERSITY Download PDFPatent Trials and Appeals BoardOct 20, 20202020000153 (P.T.A.B. Oct. 20, 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. 15/106,064 06/17/2016 Jeroen Jansen BHD-5875-25 7913 23117 7590 10/20/2020 NIXON & VANDERHYE, PC 901 NORTH GLEBE ROAD, 11TH FLOOR ARLINGTON, VA 22203 EXAMINER NEGIN, RUSSELL SCOTT ART UNIT PAPER NUMBER 1631 NOTIFICATION DATE DELIVERY MODE 10/20/2020 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): PTOMAIL@nixonvan.com pair_nixon@firsttofile.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte JEROEN JANSEN, LUTGARDE BUYDENS, LEO KOENDERMAN, BART HILVERING, and OSCAR VAN DEN BRINK Appeal 2020-000153 Application 15/106,064 Technology Center 1600 Before ERIC B. GRIMES, FRANCISCO C. PRATS, and LILAN REN, Administrative Patent Judges. REN, 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 18–28 and 30–37. See Final Act. 3. 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. Appellant identifies the real party in interest as applicants Stichting Katholieke Universiteit and University Medical Center Utrecht te Utrecht. Appeal Br. 2. Appeal 2020-000153 Application 15/106,064 2 CLAIMED SUBJECT MATTER The claims are directed to a method of “analysing data from a cytometer [wherein] the data comprises data from healthy individuals and challenged individuals.” Spec. 1:8–9. Claim 18, reproduced below, is illustrative of the claimed subject matter: 18. Computer implemented method of analysing data comprising measured values of characteristics of objects in samples, the data stored on a non-transitory computer readable medium comprising: - a first set of data (Xireference) with measured values of characteristics of ten or more reference objects in reference samples; and - a test set of data (Xitest) with measured values of the characteristics of ten or more objects in a test sample; the method comprising using a computer for, - reading the first set of data from the computer readable medium and fitting a control model to the first set of data to determine control loadings (Pcontrol) each representing an independent correlation between characteristics; - projecting the first set of data (Xireference) onto the control loadings (Pcontrol) for reference determining a first set control scores (Tcontrol,ireference) and determining one or more confidence intervals for the first set of control scores (Tcontrol,ireference); - projecting the test data onto the control loadings (Pcontrol) for determining test control scores; - using a comparator to determine if the test control scores are within the one or more confidence intervals characterized in that - a first set of control residuals (Yireference) is determined by using computation means for projecting the first set of data (Xireference) onto the control loadings (Pcontrol), and - wherein a test set of control residuals is determined by using computation means for projecting the test set of data onto the control loadings (Pcontrol), comprising Appeal 2020-000153 Application 15/106,064 3 - using computation means projecting a second set of data (Xiperturbed) with measured values of the characteristics of objects in perturbed samples onto the control loadings (Pcontrol) for determining a second set of control residuals (Yiperturbed); - using computation means for fitting a perturbation model to the second set of control residuals (Yiperturbed) to determine perturbation loadings (Pperturbation) each representing an independent correlation between characteristics; - using computation means for projecting the first set of control residuals (Yireference) onto the perturbation loadings (Pperturbation) and determining a first set of perturbation scores (TCT,ireference) - determining one or more further confidence intervals for the first set of perturbation scores (TCT,ireference); - projecting the test data onto the control loadings (Pcontrol) to determine test control residuals; - projecting the test control residuals onto the perturbation loadings (Pperturbation) and determining test perturbation scores; - comparing the test perturbation scores with the one or more further confidence intervals with a comparator; and - based on the comparison, identifying objects having the test perturbation scores outside the one or more further data confidence intervals and/or identifying presence of an illness. Claims Appendix (Appeal Br. 27–28). REJECTION Claims 18–28 and 30–37 are rejected under 35 U.S.C. § 101. Final Act. 3. Appeal 2020-000153 Application 15/106,064 4 OPINION Legal Framework In determining whether a claim falls within a category excluded from eligible subject matter, our inquiry focuses on the Supreme Court’s two-step framework described in Mayo and Alice, set forth above. Alice, 573 U.S. at 217–18 (citing Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 75–77 (2012)). In accordance with that framework, we first determine what concept the claim is “directed to.” See Alice, 573 U.S. at 219. Concepts determined to be abstract ideas, and thus patent ineligible, include mental processes (Gottschalk v. Benson, 409 U.S. 63, 67 (1972)) and mathematical formulas (Parker v. Flook, 437 U.S. 584, 594–95 (1978)). Concepts determined to be patent eligible include physical and chemical processes, such as “molding rubber products” (Diamond v. Diehr, 450 U.S. 175, 191 (1981)); “tanning, dyeing, making waterproof cloth, vulcanizing India rubber, smelting ores” (id. at 182 n.7 (quoting Corning v. Burden, 56 U.S. 252, 267–68 (1853))); and manufacturing flour (Benson, 409 U.S. at 69 (citing Cochrane v. Deener, 94 U.S. 780, 785 (1876))). However, not every claim that recites a mathematical formula is patent ineligible. In Diamond v. Diehr, 450 U.S. 175, 191 (1981), the claim at issue recited a mathematical formula, but the Supreme Court held that “[a] claim drawn to subject matter otherwise statutory does not become nonstatutory simply because it uses a mathematical formula.” Diehr, 450 U.S. at 176; see also id. at 191 (“We view respondents’ claims as nothing more than a process for molding rubber products and not as an attempt to patent a mathematical formula.”). The Supreme Court also indicated that a Appeal 2020-000153 Application 15/106,064 5 claim “seeking patent protection for that formula in the abstract . . . is not accorded the protection of our patent laws, . . . and this principle cannot be circumvented by attempting to limit the use of the formula to a particular technological environment.” Id. (citing Flook and Benson); see also, e.g., id. at 187 (“It is now commonplace that an application of a law of nature or mathematical formula to a known structure or process may well be deserving of patent protection.”). If the claim is “directed to” an abstract idea, we turn to the second step of the Alice and Mayo framework, where “we must examine the elements of the claim to determine whether it contains an ‘inventive concept’ sufficient to ‘transform’ the claimed abstract idea into a patent- eligible application.” Alice, 573 U.S. at 221 (quotation marks omitted). “A claim that recites an abstract idea must include ‘additional features’ to ensure ‘that the [claim] is more than a drafting effort designed to monopolize the [abstract idea].’” Id. (quoting Mayo, 566 U.S. at 77). In January 2019, the USPTO published revised guidance on the application of § 101. 2019 Revised Patent Subject Matter Eligibility Guidance, 84 Fed. Reg. 50 (Jan. 7, 2019) (the “2019 Revised Guidance”).2 Under the 2019 Revised Guidance, we first look to whether the claim recites: (1) any judicial exceptions, including certain groupings of abstract ideas (i.e., mathematical concepts, certain methods of organizing 2 In response to received public comments, the Office issued further guidance on October 17, 2019, clarifying the 2019 Revised Guidance. USPTO, October 2019 Update: Subject Matter Eligibility (the “October 2019 Update”) (available at https://www.uspto.gov/sites/default/files/ documents/peg_oct_2019_update.pdf). Appeal 2020-000153 Application 15/106,064 6 human activity such as a fundamental economic practice, or mental processes) (“Step 2A, Prong One”); and (2) additional elements that integrate the judicial exception into a practical application (see MPEP § 2106.05(a)–(c), (e)–(h) (9th ed. 2018)) (“Step 2A, Prong Two”).3 2019 Revised Guidance, 84 Fed. Reg. at 52–55. Only if a claim (1) recites a judicial exception and (2) does not integrate that exception into a practical application, do we then look, under Step 2B, to whether the claim: (3) adds a specific limitation beyond the judicial exception that is not “well-understood, routine, conventional” in the field (see MPEP § 2106.05(d)); or (4) simply appends well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception. See 2019 Revised Guidance, 84 Fed. Reg. at 52, 55–56. Judicial Exception (Step 2A, Prong One) Consistent with the Examiner’s analysis, claim 18 recites at least one judicial exception. Specifically, claim 18 recites a “method of analyzing data” that requires “using a computer for” an act of “fitting a control model to the first set of data to determine control loadings (Pcontrol) each representing an independent correlation between characteristics.” The portion of the Specification Appellant cites in written description support for this particular claim limitation provides that “loadings correspond to components determined in a principal component analysis. Scores refer to 3 We perform this evaluation by (a) identifying whether there are any additional elements recited in the claim beyond the judicial exception, and (b) evaluating those additional elements individually and in combination to determine whether the claim as a whole integrates the exception into a practical application. See 2019 Revised Guidance - Section III(A)(2), 84 Fed. Reg. at 54–55. Appeal 2020-000153 Application 15/106,064 7 the expression on the components (loadings) and may be seen as coefficients in the linear model wherein the components are variables.” Spec. 9:8–10 (cited in Appeal Br. 4). The Specification provides equation (1) (an image of which is reproduced below as Figure 1) for describing such a control model. Id. at 9:29–31. Fig. 1. An Image of Equation (1) from the Specification. Spec. 9:31. The Specification further provides that “Pcontrol is a matrix (J × Rcontrol) representing the control loadings.” Id. at 10:7. These actions, particularly the application of equation (1), involve mathematical concepts. Claim 18 further recites acts of “projecting” certain data for “determining” various parameters including “confidence intervals” and “a first set of control scores” followed by “using a comparator to determine if the test control scores are within the one or more confidence intervals.” The Specification provides, for example, that “a confidence interval . . . indicates the variability between objects observed in reference samples” (Spec. 9:14– 15 (cited in Appeal Br. 5)) and that “[t]he matrices Tcontrol,ireference for all reference samples together form a first set of control scores.” Id. at 10:5–6. These actions involve mathematical concepts such as matrices. Claim 18 also recites “a test set of control residuals is determined by using computation means for projecting the test set of data onto the control loadings (Pcontrol)” which comprises various additional limitations of “using computation means for” various functions such as “projecting a second set of data” and “fitting a perturbation model” followed by “comparing the test perturbation scores with the one or more further confidence intervals with a comparator.” The Specification provides equation (2) (an image of which is Appeal 2020-000153 Application 15/106,064 8 reproduced below as Figure 2) for “the model of perturbed samples in a second set of data.” Spec. 11:18–19. Fig. 2. An Image of Equation (2) from the Specification. Spec. 11:20. The Specification goes on to provide equation (3) (an image of which is reproduced below as Fig. 3) for a perturbation model. Spec. 13:20–23 (cited in Appeal Br. 6). Fig. 3. An Image of Equation (3) from the Specification. Spec. 13:23. These actions, particularly the application of equations (2) and (3), involve mathematical concepts. The Specification goes on to provide equation (4) (an image of which is reproduced below as Fig. 4) for the calculation of Yireference. Spec. 14:23. Fig. 4. An Image of Equation (4) from the Specification. Spec. 14:23. The action involving the application of equation (4), involves mathematical concepts. Claim 18 additionally recites “based on the comparison, identifying objects having the test perturbation scores outside the one or more further data confidence intervals and/or identifying presence of an illness.” Such identification is based on the application of the mathematical concepts and thus cannot be separated therefrom. Moreover, comparing and identifying a Appeal 2020-000153 Application 15/106,064 9 difference which could be indicative of an anomaly and an illness is well within a human’s mental activity.4 The Examiner finds that claim 18 is directed to an abstract idea of a mathematical formula. Final Act. 3; Ans. 3. Appellant acknowledges that “some of the limitations in the claims are based on mathematical concepts[.]” Appeal Br. 19. The Specification provides a table of a specific “[a]lgorithm” which “comprises some steps of the method” and states, for example, that the “[t]he perturbation scores, the perturbation loadings and the perturbation residuals are computed using computation means.” Spec. 15–16, 13:29–30. Appellant’s citation to certain examples in the 2019 Revised Guidance does not provide an elaborated argument with any explanation as to why these examples are similar to the claims at issue here. See Appeal Br. 19. Given that claim 18 recites an abstract idea, we proceed with the next step in the analysis. Appellant does not raise separate arguments for other pending claims under prong 1. Appeal Br. 18–19. Integration into a Practical Application (Step 2A, Prong 2) Turning to Step 2A, Prong 2 of the 2019 Revised Guidance, we determine that claim 18, as a whole, does not integrate the judicial exception into a practical application. Integration into a practical application requires an additional element or a combination of additional elements in the claim to “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 exception.” 2019 Revised 4 The Examiner finds that “diagnosing an illness is a mental step” and falls under the judicial exception. Ans. 3. Appellant does not respond to this finding. Reply Br. 3. Appeal 2020-000153 Application 15/106,064 10 Guidance, 84 Fed. Reg. at 53–54; see also id. at 55 (setting forth exemplary considerations indicative that an additional element or combination of elements may have integrated the judicial exception into a practical application). Consistent with the Examiner’s determination that claim 18 recites limitations that are no more than “data manipulations” (Final Act. 3), Appellant acknowledges that the method is “better suited to describe the data of reference samples than” the prior art. Appeal Br. 18. Appellant argues that “the claimed features provide methods and systems that are better suited to describe the data of reference samples for determining the presence of an illness automatically while avoiding subjective influence and differences between operators or laboratories” but does not explain how the limitations of claim 18 are integrated into such a purported application. Id. at 19. In any event, identifying the presence of an illness is not required by claim 18 as it recites “and/or identifying the presence of an illness.” Appeal Br. 28. Appellant argues that claim 18 “sets forth features for identifying objects having the test perturbation scores outside the one or more further data confidence intervals and/or identifying presence of an illness” and thus integrates the mathematical concept into a practical application. Appeal Br. 20; see also id. at 23, 24. As the October 2019 Update to the 2019 Revised Guidance explains, “[a]n important consideration to evaluate when determining whether the claim as a whole integrates a judicial exception into a practical application is whether the claimed invention improves the functioning of a computer or other technology.” October 2019 Update, 12. To do so, we consider whether Appellant’s Specification “provides sufficient details such that one of ordinary skill in the art would recognize the claimed invention as Appeal 2020-000153 Application 15/106,064 11 providing an improvement.” Id. If the Specification sets forth an improvement in technology, we then evaluate claim 18 “to ensure that the claim itself reflects the disclosed improvement.” Id. Here, the Specification provides: “Objects (here cells) having scores outside the confidence interval may be identified using a comparator of the computer and separated from the other objects in a sample by a sorter. Sorters are well known for flow cytometers.” Spec. 13:7–9 (cited in Appeal Br. 6 as written description support for claim 18). Not only are such comparator and sorters well known in the art as acknowledged by the Specification (id.), but the Specification also does not support Appellant’s argument that there is any “improvement” sufficient to integrate the judicial exception into a practical application. Moreover, the Specification provides that the recited method for “analyzing data” seeks to address “the complexity of the calculations” because “performing the principal component analysis by hand is only possible for around 2 objects.” Spec. 1:9, 27–28. Thus the recited “method may be executed using a computer running software.” Id. at 17:3. Any purported improvement accomplished by claim 18 (such as the avoidance of subjective influences (Appeal Br. 24)) is therefore a result of addressing “the complexity of the calculations” which is a generic function of a general purpose computer. See id. at 1:27; see also 2019 Guidance (identifying “add[ing] insignificant extra-solution activity to the” abstract idea as an example of when an abstract idea has not been integrated into a practical application). Likewise, comparing results of a calculation using a computer is insignificant post-solution activity. See Elec. Power Grp. LLC v. Alstom, 830 F.3d 1350, 1353 (Fed. Cir. 2016) (pointing out “that merely presenting the results of abstract processes of collecting and analyzing information, Appeal 2020-000153 Application 15/106,064 12 without more (such as identifying a particular tool for presentation), is abstract as an ancillary part of such collection and analysis”). Appellant’s preemption argument (Appeal Br. 19) is also unpersuasive. In particular, preemption is not a stand-alone test for patent eligibility. Although preemption “‘might tend to impede innovation more than it would tend to promote it,’ thereby thwarting the primary object of the patent laws” (Alice, 573 U.S. at 216 (quoting Mayo, 566 U.S. at 71)), “the absence of complete preemption does not demonstrate patent eligibility” (Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371, 1379 (Fed. Cir. 2015)); see also OIP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1362–63 (Fed. Cir. 2015) (“[T]hat the claims do not preempt all price optimization or may be limited to price optimization in the e-commerce setting do not make them any less abstract.”). Appellant additionally argues that claim 19 “is directed to a specific device,” more specifically, a cytometer, which integrates claim 19 into a practical solution. Appeal Br. 20. Claim 19 does not recite a cytometer. In any event, the Specification provides that the recited method is for “analyzing data from a cytometer” (Spec. 1:9–10) and receiving data from a cytometer does not integrate the mathematical concept involved in analyzing such data into a practical application. In sum, neither the Specification nor Appellant’s unelaborated arguments show that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation. Accordingly, we determine the additional elements do not integrate the abstract concept of judicial exception into a practical application. CLS Bank Int'l v. Alice Corp. Pty. Ltd., 717 F.3d 1269, 1286 (Fed. Cir. 2013) (en banc) (“[S]imply Appeal 2020-000153 Application 15/106,064 13 appending generic computer functionality to lend speed or efficiency to the performance of an otherwise abstract concept does not meaningfully limit claim scope for purposes of patent eligibility.”), aff’d, 573 U.S. 208 (2014). Inventive Concept (Step 2B) Turning to Step 2B, we next analyze whether claim 18 adds any specific limitation beyond the judicial exception that is not “well- understood, routine, conventional” in the field. 2019 Revised Guidance, 84 Fed. Reg. at 56; MPEP § 2106.05(d). In so doing, we analyze the claim elements individually and as an ordered combination. See Alice, 573 U.S. at 217–18, 221–22 (“[W]e consider the elements of each claim both individually and ‘as an ordered combination’” to determine whether the claim includes “significantly more” than the ineligible concept) (quoting Mayo, 566 U.S. at 78–79); see also BASCOM Glob. Internet Servs., Inc. v. AT&T Mobility LLC, 827 F.3d 1341, 1350 (Fed. Cir. 2016) (“[A]n inventive concept can be found in the non-conventional and non-generic arrangement of known, conventional pieces.”). Here, claim 18 recites no more than a generic “non-transitory computer readable medium” and the operations are recited as performing generic computer functions routinely used in computer applications. Generic computer components recited as performing generic computer functions that are well-understood, routine and conventional activities amount to no more than implementing the abstract idea with a computerized system. The use of generic computer components in this manner does not impose any meaningful limit on the computer implementation of the abstract idea. As the Examiner points out, “the combination of computer programs and flow cytometry is routine and conventional in the art.” Ans. 4. Appeal 2020-000153 Application 15/106,064 14 Court decisions have recognized that generic computer-system components operating to communicate, manipulate, and display data are well understood, routine, and conventional to a skilled artisan. See, e.g., Alice, 573 U.S. at 226–27; SAP Am., Inc. v. InvestPic, LLC, 898 F.3d 1161, 1164–65 & n.1, 1170 (Fed. Cir. 2018); Apple, Inc. v. Ameranth, Inc., 842 F.3d 1229, 1234, 1241–42 (Fed. Cir. 2016); Symantec, 838 F.3d at 1316–20; Versata Dev. Group Inc. v. SAP Am. Inc., 793 F.3d 1306, 1334 (Fed. Cir. 2015); Ultramercial, Inc. v. Hulu, LLC, 772 F.3d 709, 715–716 (Fed. Cir. 2014); buySAFE, 765 F.3d at 1355. Appellant argues, without elaboration, that “there is no evidence that the computer performing or configured to perform the operations recited in the claims is well understood, routine, or conventional.” Appeal Br. 24. Appellant, however, does not identify any particular limitation in claim 18 showing that the computer used to carry out the algorithm as exemplified in the Specification (Spec. 15–16) is anything other than a general purpose computer. Moreover, contrary to Appellant’s assertion that the Examiner “fails to address the argument that the requirement to provide evidence under guidance per Berkheimer” (Reply Br. 4), the Examiner, in the Final Office Action, states that “the prior art review article of Laerum et al. teach that the flow cytometry limitations recited outside the claims are routine and conventional in the prior art.” Final Act. 4 (addressing Appellant’s argument with regard to Berkheimer). Appellant does not dispute the Examiner’s finding with regard to the prior art reference Laerum in the opening brief. See, e.g., Appeal Br. 15–25.5 5 We decline to address the belatedly raised argument with regard to Laerum in the Reply Brief. See Reply Br. 4. An argument raised for the first time in a Reply Brief can be considered waived if Appellant does not explain why it Appeal 2020-000153 Application 15/106,064 15 Accordingly, in the absence of evidence or argument to the contrary, we determine claim 18 fails to add any specific limitation beyond the judicial exception that is not “well-understood, routine, conventional” in the field. Because the Examiner correctly concluded claim 18 is directed to a judicial exception, and because Appellant does not identify any error in the Examiner’s determination under the 2019 Revised Guidance, we sustain the rejection of claim 18 under 35 U.S.C. § 101. The rejection of all other pending claims is sustained for the same reason. CONCLUSION The Examiner’s rejection is affirmed. More specifically, could not have been raised previously. See Ex parte Nakashima, 93 USPQ2d 1834 (BPAI 2010) (informative) (explaining that arguments and evidence not timely presented in the principal Brief will not be considered when filed in a Reply Brief, absent a showing of good cause explaining why the argument could not have been presented in the Principal Brief); Ex parte Borden, 93 USPQ2d 1473, 1477 (BPAI 2010) (informative) (“Properly interpreted, the Rules do not require the Board to take up a belated argument that has not been addressed by the Examiner, absent a showing of good cause.”). Appellant has not explained why the argument could not have been raised in the opening brief to afford the Examiner an opportunity to respond. We therefore decline to address the belatedly raised argument. See Ex Parte Hindersinn, 177 USPQ 78, 80 (Bd. App. 1971). Appeal 2020-000153 Application 15/106,064 16 DECISION SUMMARY Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 18–28, 30– 37 101 Eligibility 18–28, 30– 37 TIME PERIOD FOR RESPONSE 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