Bhubaneswar Mishra et al.Download PDFPatent Trials and Appeals BoardAug 29, 201913266662 - (D) (P.T.A.B. Aug. 29, 2019) 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. 13/266,662 10/27/2011 Bhubaneswar Mishra 191263.US.02-32882-214035 1573 120944 7590 08/29/2019 Hunton Andrews Kurth LLP/HAK NY Attention: Intellectual Property - Patent Docket 200 Park Avenue New York, NY 10016 EXAMINER HARWARD, SOREN T ART UNIT PAPER NUMBER 1631 NOTIFICATION DATE DELIVERY MODE 08/29/2019 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): nydocket@andrewskurth.com ptony@andrewskurth.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte BHUBANESWAR MISHRA and GIUSEPPE NARZISI1 ____________ Appeal 2019-001691 Application 13/266,662 Technology Center 1600 ____________ Before TONI R. SCHEINER, RICHARD M. LEBOVITZ, and DEBORAH KATZ, Administrative Patent Judges. LEBOVITZ, Administrative Patent Judge. DECISION ON APPEAL The claims is this appeal are directed to computer executable instructions, methods, and systems for assembling a genetic sequence. The Examiner rejected the claims under 35 U.S.C. § 101 as directed to non- statutory subject matter. Pursuant to 35 U.S.C. § 134, Appellant appeals the Examiner’s determination that the claims are unpatentable. We have jurisdiction for the appeal under 35 U.S.C. § 6(b). The Examiner’s decision is affirmed. 1 The Appeal Brief (“Appeal Br.” entered Sept. 5, 2018) lists New York University of New York, New York as the Real Party in Interest. Appeal Br. 3. Appeal 2019-001691 Application 13/266,662 2 STATEMENT OF THE CASE Claims 42–75 stand rejected by the Examiner under 35 U.S.C. § 101 as directed to non-statutory subject matter ineligible for a patent. Ans. 3. There are three independent claims, claims 42, 53, and 65. Claim 42 is directed to a “non-transitory computer-accessible medium having stored thereon computer executable instructions for assembling at least one genetic sequence,” claim 53 is to a “method for assembling at least one genetic sequence,” and claim 65 is to a “system for assembling at least one genetic sequence.” Appellants did not provide separate arguments for the claims. Because the claims were not argued separately by Appellants and because the steps are the same, or substantially similar (Appeal Br. 25), we address all three independent claims together, as well as the dependent claims. The claims stand or fall together. 37 C.F.R. § 41.37(c)(1)(iv). Claim 53, which is representative of the appealed claims, is reproduced below: 53. A method for assembling at least one genetic sequence, comprising: (a) obtaining a series of raw intensity outputs from a sequencing platform configured to be used for reading a fragment of at least one genome; (b) obtaining at least one reference sequence for the at least one genome, wherein the at least one reference sequence for the at least one genome is obtained independently from the series of raw intensity outputs obtained from the sequencing platform; (c) automatically generating a search tree comprising a plurality of nodes, wherein each of the plurality of nodes corresponds to a particular nucleotide base; (d) automatically selecting a node of the plurality of nodes in the search tree; Appeal 2019-001691 Application 13/266,662 3 (e) automatically expanding the selected node by creating a plurality of child nodes, each of the child nodes corresponding to a particular further nucleotide base; (f) automatically generating a score for one or more of the child nodes, wherein the score is a function of (i) at least one raw intensity output from the series of raw intensity outputs, (ii) the plurality of reference sequences, and (iii) the nucleotide base to which a particular one of the plurality of child nodes corresponds; (g) automatically selecting one or more of the plurality of child nodes based on the score; (h) automatically repeating procedures (e)–(g) for the selected child node; (i) automatically generating a path through the plurality of nodes; and (j) using a computer hardware arrangement, automatically assembling the at least one genetic sequence based on the path. REJECTION UNDER § 101 The Examiner rejected claims 42–75 under 35 U.S.C. § 101 as directed to a judicial exception to patent eligibility. Ans. 3. The Examiner found that the claims are directed to an abstract idea which is a judicial exception to patent eligibility under § 101. Ans. 6. Under 35 U.S.C. § 101, an invention is patent-eligible if it claims a “new and useful process, machine, manufacture, or composition of matter.” However, not every discovery is eligible for patent protection. Diamond v. Diehr, 450 U.S. 175, 185 (1981). “Excluded from such patent protection are laws of nature, natural phenomena, and abstract ideas.” Id. The Supreme Court articulated a two-step analysis to determine whether a claim falls within an excluded category of invention. Alice Corp. v. CLS Bank Int’l, Appeal 2019-001691 Application 13/266,662 4 573 U.S. 208, 216 (2014); Mayo Collaborative Servs. v. Prometheus Labs, Inc., 566 U.S. 66, 75–77 (2012). In the first step, it is determined “whether the claims at issue are directed to one of those patent-ineligible concepts.” Alice, 566 U.S. at 217. If it is determined that the claims are directed to an ineligible concept, then the second step of the two-part analysis is applied in which it is asked “‘[w]hat else is there in the claims before us?’” Id. The Court explained that this step involves . . . 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.” Alice, 566 U.S. at 217–18 (citing from Mayo, 566 U.S. at 75–77). Alice, relying on the analysis in Mayo of a claim directed to a law of nature, stated that in the second part of the analysis “the elements of each claim both individually and ‘as an ordered combination’” must be considered “to determine whether the additional elements ‘transform the nature of the claim’ into a patent-eligible application. Alice, 566 U.S. at 217. The PTO recently published revised guidance on the application of § 101. USPTO’s January 7, 2019 Memorandum, 2019 Revised Patent Subject Matter Eligibility Guidance, 84 Fed. Reg. 50, 51–57 (2019) (“2019 Eligibility Guidance”). This guidance provides direction on how to implement the two-part analysis of Mayo and Alice. Step 2A, Prong One, of the 2019 Guidelines, looks at the specific limitations in the claim to determine whether the claim recites a judicial exception to patent eligibility. In Step 2A, Prong Two, the claims are Appeal 2019-001691 Application 13/266,662 5 examined to identify whether there are additional elements in the claims that integrate the exception in a practical application, namely, is there a “meaningful limit on the judicial exception, such that the claim is more than a drafting effort designed to monopolize the judicial exception.” 84 Fed. Reg. at 53 (“2. Prong Two”). If the exception is not integrated into a practical application, then as in the Mayo/Alice framework, Step 2B of the 2019 Guidelines asks whether there is an inventive concept to ensure that the patent is significantly more than a patent on the ineligible concept, itself. In making this determination, it must be considered whether there are specific limitations or elements recited in the claim “that are not well-understood, routine, conventional activity in the field, which is indicative that an inventive concept may be present” or whether the claim “simply appends well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, which is indicative that an inventive concept may not be present.” 84 Fed. Reg. at 56. With these guiding principles, we proceed to determine whether the claimed subject matter in this appeal is eligible for patent protection under 35 U.S.C. § 101. As explained in more detail below, we conclude that the claims are directed to patent-ineligible subject matter. Step 2A, Prong One In Step 2A, Prong One, of the 2019 Guidelines, the specific limitations in the claim are examined to determine whether the claim recites a judicial exception to patent eligibility, i.e., whether the claim recites an Appeal 2019-001691 Application 13/266,662 6 abstract idea, law of nature, or natural phenomenon. The Examiner found that the claim recites an abstract idea. The 2019 Eligibility Guidance identifies three groupings (a)–(c) as abstract ideas. 84 Fed. Reg. 52. As explained in more detail below, the claim recites subject matter which fits into grouping (a), “Mathematical concepts–mathematical relationships, mathematical formulas or equations, mathematical calculation.” Claim 53 is directed to a “method for assembling at least one genetic sequence.” In broad terms, the method is for identifying nucleotides at specific positions of a genome fragment by applying mathematical operations to raw intensity outputs obtained from nucleotide sequencing technology. The process is also called “base-calling” because the identity of a nucleotide base at a position in a genome sequence is “called out” by carrying out the steps of the method. See Spec. ¶ 32. By using the method, and aligning it with a reference sequence, accurate nucleotide sequence polymorphisms can be identified. See Spec. ¶ 6. Step (a) of the claim is directed to “obtaining . . . raw intensity outputs obtained from the sequencing platform.” The “sequencing platform” is the nucleotide base sequencing technology used to detect the nucleotides in the recited “genome fragment.” Spec. ¶ 34. “Raw intensity outputs” represent the intensity values generated by the nucleotide base sequencing, namely the signal intensities for each of the A, C, G, and T bases. Spec. ¶ 101. The example in the Specification is fluorescence light intensity using the Illumina sequencing technology. Id. The sequence data from step (a) is obtained from reading the nucleotide base sequence of a fragment of a genome. The sequence data of claims (b) is from a reference nucleotide Appeal 2019-001691 Application 13/266,662 7 sequence from the genome. Steps (a) and (b) thus comprise obtaining nucleotide sequence data. Steps (c) through (i) each use the term “automatically” to describe a step in the claim, indicating that the subsequently recited instructions are computations performed by a computer with no human intervention. The instructions or steps recited in these steps are mathematical operations performed on nodes in a search tree, where the nodes represent nucleotides. As explained in the Appeal Brief and the Specification, the purpose of the steps is to identify the particular nucleotide, A, T, C, and G, at a specific location in the genome fragment, i.e., base-calling. Appeal Br. 9–14. The Specification explains: Figure 4 shows a diagram of an exemplary tree that can be generated by an exemplary base-caller procedure in accordance with certain exemplary embodiments of the present disclosure. As shown in Figure 4, an exemplary tree 400 can include root 401 corresponding to cycle 0. The tree 400 can be a quaternary tree (e.g., branching factor = 4), where, at each cycle, each node can be expanded by 4, corresponding to A, T, C, and G, for example. Spec. ¶ 98. Step (f) of the claim specifically recites “generating a score for one or more of the child nodes” where “the score is a function of (i) at least one raw intensity output from the series of raw intensity outputs, (ii) the plurality of reference sequences, and (iii) the nucleotide base to which a particular one of the plurality of child nodes corresponds.” The score, described in the Specification as a “score function” is derived using mathematical operations: The exemplary score function (and/or components thereof) can be built from (e.g., generated, derived from, based upon, etc.) the logarithm of intensity information from each base-read and Appeal 2019-001691 Application 13/266,662 8 its variance-based weighting of squared deviations computed using a distribution of similar positional intensities stored in an exemplary database. Spec. ¶ 81. Thus, the Specification defines step (f) as a mathematical concept and an abstract idea. The last step (j) of the method comprises “automatically assembling the at least one genetic sequence based on the path.” (Claims App. A–5). The Specification does not define “assembling,” but we understand it to mean producing one genome nucleotide sequence from the “series of raw intensity outputs” obtained in step (a) of the claim by following the instructions recited in steps (c)–(i) of the claim. Id. In sum, the steps performed in claim 53 comprise “Mathematical concepts” and “mathematical calculations,” falling into grouping (a) of the three groupings identified as abstract ideas. 84 Fed. Reg. 52. We reach this conclusion, consistent with the Examiner’s analysis, because steps (c)–(i) of the claim each involve performing mathematical operations on a node, where the node is mathematical representation of nucleotide. Spec. ¶¶ 62, 64, 80, 98. For example, as explained in the Specification, the nodes are repeatedly expanded by branching to form a path that is used to determine the sequence of the genome fragment. See Spec. ¶ 62, Fig. 4. The Specification defines these steps mathematically and thus the steps are abstract ideas. Step (j) of the claim is assembling a nucleotide base sequence (the “genetic sequence” of the claims) based on the preceding mathematical operations and thus is a mathematical operation, itself. Appeal 2019-001691 Application 13/266,662 9 Step 2A, Prong Two In the second step of the analysis, when the claim is found to recite a judicial exception, the 2019 Guidelines direct us to “evaluate whether the claim as a whole integrates the recited judicial exception into a practical application of the exception.” 84 Fed. Reg. 54 (in section titled “2. Prong Two”). Thus, because claim 53 is directed to a judicial exception – an abstract idea – , we proceed to the second step of the analysis. The 2019 Guidelines explains: A claim that integrates a judicial exception into a practical application will apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that the claim is more than a drafting effort designed to monopolize the judicial exception. 84 Fed. Reg. 54. In this case, the mathematical operations recited in the claim are for the purpose of assembling a nucleotide sequence from raw intensity outputs obtained from a nucleotide sequencing platform. The issue is whether these mathematical operations to assemble a nucleotide sequence constitute a practical application. Appellants argue that the claims are “directed to an improvement of an existing technology” which they characterize as “assembling genetic sequences,” because the method “improves the reliability in generating genome sequences, and improves the reliability of population-wide genomic studies.” Appeal Br. 28. However, not every improvement to a technology is patent-eligible. In Parker v. Flook, 437 U.S. 584, 594–95, claims to updating alarm limits were found to be ineligible for patent, despite providing “a new and Appeal 2019-001691 Application 13/266,662 10 presumably better method for calculating alarm limit values.” In Flook, the claim was directed to a “method for updating the value of at least one alarm limit on at least one process variable involved in a process comprising the catalytic chemical conversion of hydrocarbons.” Flook, 437 U.S. at 596–97 (Appendix to Opinion). The steps comprised determining a new alarm base using a mathematical algorithm, using the alarm base to update an alarm limit, and then adjusting the alarm limit to the updated value. Id. The Court found the claim to be unpatentable under Section 101. The Court held that “[t]he process itself, not merely the mathematical algorithm, must be new and useful.” Id. at 591. All the independent claims in this appeal perform mathematical operations on raw sequencing data (“raw intensity outputs”) to improve the sequencing technology to assemble a genetic sequence. Appellants argue that “there is no mathematical operation recited in any of the claims of the present application” (Appeal Br. 27), but do not explain what the steps involving generating “a search tree comprising a plurality of nodes” as recited in step (c), and then selecting nodes (step (d)), expanding nodes (step (e)), and automatically generating score for nodes (step (f)) are, if not mathematical operations or concepts.2 Consistent with the finding that the 2 Mathematics is defined as “the science of numbers and their operations . . . , interrelations, combinations, generalizations, and abstractions and of space . . . configurations and their structure, measurement, transformations, and generalizations // Algebra, arithmetic, calculus, geometry, and trigonometry are branches of mathematics.” https://www.merriam-webster.com/dictionary/mathematics (last accessed June 26, 2019). Appellants made the conclusory statement that the search trees utilized in the claims are not mathematical operations, but did not provide evidence that one of ordinary skill in the art would not have Appeal 2019-001691 Application 13/266,662 11 steps constitute mathematical operations, the Specification describes the processes performed on the nodes in terms of mathematical concepts: It is possible to perform global optimization (or near optimization) by searching the hypotheses space potentially exhaustively (or near exhaustively) utilizing an intelligent pruning procedure using exemplary branch-and-bound heuristics. For example, the search tree can be a pruned quaternary tree (e.g., branching factor = 4), where each node in position j can be expanded to the j+1) position by augmenting the path with the base A, T, C, and G, and scoring a new resulting path for the hypothesis that it could have generated the data, which, in reality, can be obtained from the sequencing platform. If the score for a new node is below the desired range, the node can be pruned. In a more aggressive approach, it can be possible to utilize an exemplary embodiment using beam- search heuristics where at any point only a fixed number (e.g., k = 20} of the best possible hypotheses can be allowed to survive pruning and be included. Spec. ¶ 62 (emphasis added). Generate a QUATERNARY Tree by, e.g., starting with an unexplored leaf node (labeled by a nucleotide base) with the best score-value, selecting all four possible nucleotide bases (e.g., A, T, C, G) to expand the node by making them its children and computing their scores, and repeating until the tree cannot be expanded any further. Spec. ¶ 80 (emphasis added). As shown in Figure 2, it is possible to start with a null set of leaves T 203 = 0, and a set of live nodes L 204. The set of live considered them to embody mathematical concepts which the 2019 Guidelines characterize as abstract ideas. We recognize that the steps are not simple mathematical calculations as they were in Flook, but rather are mathematical operations performed on a computer. However, Appellants have not explained why such operations are not abstract ideas as the “algorithms” were in Flook. Appeal 2019-001691 Application 13/266,662 12 nodes L 204 can include nodes queued in a first in, first out (FIFO) basis, such that L = {(Ro.g(Ro))}. Spec. ¶ 95.3 Step (a) comprises obtaining the nucleotide information in the form of “raw intensity outputs.” Step (b) is obtaining a reference sequence. These steps are not a practical application of the abstract idea recited in the claims, but rather involve the collection of information that is necessary to perform the abstract idea.4 The result of steps (c)–(i) is recited in step (j) of claim 53 to be “automatically assembling the at least one genetic sequence based on the path.” The assembled “genetic sequence” is therefore the solution when the steps of the claimed method are accomplished on the “raw intensity outputs.” The skilled worker is not instructed to do anything with the assembled genetic sequence that would integrate it into a practical application. Indeed, the solution to following the instructions in claim 53 is to discover the naturally-occurring sequence of the recited “fragment of at least one genome.” Spec. ¶ 33. The discovery of a natural phenomenon, namely the sequence of a genome fragment, is not itself patent eligible under Mayo, 566 U.S. at 77–78 (“tell[ing] a doctor about the relevant natural laws” does not make an otherwise patent-ineligible claim, eligible). 3 The letters T, L, R, and g appear in an italicized font in the Specification, but are shown as Times New Roman here because the specific font could not be identified 4 The collection of information in the context of analyzing it and displaying the result was still found to be an abstract idea in Electric Power Group, LLC v. Alstom S.A., 830 F.3d 1350, 1354–55 (2016). Appeal 2019-001691 Application 13/266,662 13 We have not been directed by Appellants to any additional element in the claims beyond the judicial exception. See 84 Fed. Reg. 55. As explained in the 2019, the additional element must apply or use “the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception.” Id. at 55. In this case, the mathematical operations are performed on output obtained from a specific environment, namely nucleotide sequencing, but we have not been directed to an element outside the mathematical operations applied to the nodes and score function that involve a practical application or that improve the technology involved in obtaining the raw intensity outputs. Independent claims 53, 62, and 65 are limited to an improvement in the mathematical operations performed on raw intensity outputs from a sequencing platform. However, “the prohibition against patenting abstract ideas ‘cannot be circumvented by attempting to limit the use of the formula to a particular technological environment.’” Bilski v. Kappos, 561 U.S. 593, 610 (2010). Without additional limitations, a process that employs mathematical algorithms to manipulate existing information to generate additional information is not patent eligible. “If a claim is directed essentially to a method of calculating, using a mathematical formula, even if the solution is for a specific purpose, the claimed method is nonstatutory.” Parker v. Flook, 437 U.S. 584, 595, 98 S.Ct. 2522, 57 L.Ed.2d 451 (1978) (internal quotations omitted). Digitech Image Technologies LLC v. Electronics for Imaging Inc., 758 F.3d 1344, 1351 (Fed. Cir. 2014). Appeal 2019-001691 Application 13/266,662 14 Here, while the specific purpose of the claim is to assemble a genetic sequence, the steps recited in the claim that instruct one of ordinary skill in the art to make that sequence are simply calculations/instructions that manipulate the existing raw intensity output to arrive at the mathematical solution of “at least one genetic sequence based on the path” of the preceding steps performed on nodes. Appellants cite to a number of cases from the Federal Circuit Court of Appeals to support their argument that the rejected claims are patent- eligible. The core of their argument is that the claims in these cases were directed to technological improvements, as are the rejected claims in this appeal. Appellants cite the following cases: - “directed to an improvement of an existing technology” (“a self- referential table for a computer database”) (Enfish, LLC v. Microsoft Corporation, et al., 822 F.3d 1327 (Fed. Cir. 2016)) (Appeal Br. 21); - “the claims solve a technological problem, improve the performance of the system itself” (Amdocs (Israel) Ltd. V. Openet Telecom, Inc. 841 F.3d 1288 (Fed. Cir. 2016)) (Appeal Br. 23); - “the claims in Thales ‘result in a system that reduces errors in an inertial system that tracks an object on a moving platform.’ . . . the improvement in Thales is not directed to a computer itself. Rather, the improvement in the technology in Thales is a system that reduces errors in inertial tracking systems.” (Thales Visionix, Inc. v. U.S., 850 F.3d 1343 (Fed. Cir. 2017)) (Appeal Br. 23). Appellants contend that the claims involved in this appeal are similar to the claims in these cases because they “are directed to an improvement of an existing technology (e.g., assembling genetic sequences at least because it Appeal 2019-001691 Application 13/266,662 15 improves the reliability in generating genome sequences, and improves the reliability of population-wide genomic studies)” and they are an improvement “due to the decreased complexity and the high level of accuracy that result from the use of the claimed subject matter.” Appeal Br. 28. “In particular, similar to [DDR Holdings, LLC v. Hotels.com, L.P. 773 F.3d 1245 (Fed. Cir. 2014)], the claimed solution of the present application is rooted in computer technology by solving the problem of genetic sequencing.” Appeal Br. 27. Appellants also argue that the claims do not preempt other approaches. These arguments do not persuade us that the Examiner erred in finding the claims nonstatutory and ineligible for a patent. Appellants provided evidence in the background section of their application that the claimed method is an improvement to genetic sequencing technology. The Examiner did not dispute this assertion. However as explained above, the improvement is not to the sequencing technology itself (e.g., producing the raw intensity outputs), but to the mathematical operations and concepts which improve nucleotide base-calling using the existing sequencing technology. As discussed in Sap America, Inc. v. Investpic, LLC, 898 F.3d 1161, 1167 (2018): We have explained that claims focused on “collecting information, analyzing it, and displaying certain results of the collection and analysis” are directed to an abstract idea. Electric Power, 830 F.3d at 1353. “Information as such is an intangible,” hence abstract, and “collecting information, including when limited to particular content (which does not change its character as information), [i]s within the realm of abstract ideas.” Id. (citing cases). So, too, is “analyzing information ... by mathematical algorithms, without more.” Id. at 1354 (citing cases, including Parker v. Flook, 437 U.S. 584, Appeal 2019-001691 Application 13/266,662 16 98 S.Ct. 2522, 57 L.Ed.2d 451 (1978), and Gottschalk v. Benson, 409 U.S. 63, 93 S.Ct. 253, 34 L.Ed.2d 273 (1972)). And “merely presenting the results of abstract processes of collecting and analyzing information, without more (such as identifying a particular tool for presentation), is abstract as an ancillary part of such collection and analysis.” Id. (citing cases). The bottom line here is that Appellants are asking us to find that improvements to nucleotide sequencing technology, and specifically to the mathematical concepts applied in assembling a genetic sequence of a genome fragment, is patent-eligible subject matter in the same way that improvements to website visitor retention in DDR, processing network information in Amdocs, and improving a data storage and retrieval system for a computer memory in Enfish were patent-eligible. We have not been directed to a case that holds that mathematical improvements to nucleotide sequencing technology constitute a practical, patent-eligible, application. As emphasized above, the improvements pointed out by Appellants, i.e., “reliability in generating genome sequences,” “high level of accuracy,” “accurately assembl[ing] a genetic sequence, and reduc[ing] errors as compared to previous systems”, etc., (Appeal Br. 28, 32) are all achieved by the mathematical concepts embodied by the claims (e.g., operations performed on the nodes representing nucleotides). The steps are performed on a computer with no improvement to the computer, itself, but instead use generic computer parts to carry out computer executable instructions (see preamble of claim 42). What distinguishes the claims found to be patent eligible in DDR, Amdocs, Enfish, etc., from the rejected claims in this appeal is that the improvements in the cited cases were to a technology, and not to a Appeal 2019-001691 Application 13/266,662 17 mathematical operation, itself. Thus, in DDR, there was an improvement to internet function, in Amdocs to how network information is handled, and in Enfish, to computer memory. Here, the claim is not directed to improving how physical nucleotide sequencing is performed; instead, all the steps of the claim involve performing mathematical operations on information obtained from a sequencing platform to make the base-calling more accurate and reliable by using mathematical operations. Nothing is done with the resulting assembled sequence except to reveal it. Because we have determined that the rejected claims are directed to a judicial exception and not integrated into a practical application, we move to Step 2B in which the claims are examined to determine if an inventive concept is provided. Step 2B As explained in the 2019 Guidelines, if the exception is not integrated into a practical application, then Step 2B of the 2109 Guidelines, as in the Mayo/Alice framework, asks whether there is an inventive concept. To determine whether an unpatentable law of nature has been transformed “into a patent-eligible application of such law,” the Court in Mayo held that the claim as a whole must be examined to determine whether it “also contain[s] other elements or a combination of elements, sometimes referred to as an ‘inventive concept,’ sufficient to ensure that the patent in practice amounts to significantly more than a patent upon the natural law itself.” Mayo, 566 U.S. at 72–73. Under this step, we are directed to ask whether an additional element or combination of elements recited in the claims: • Adds a specific limitation or combination of limitations that are not well-understood, routine, Appeal 2019-001691 Application 13/266,662 18 conventional activity in the field, which is indicative that an inventive concept may be present; or • simply appends well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, which is indicative that an inventive concept may not be present. 84 Fed. Reg. 56. While Appellants recognized that a claim is patent eligible when additional elements that amount to “significantly more than the abstract idea” are present in the claims (Appeal Br. 21, 22, 25, 26). Appellants did not identify an element in the claim that adds “significantly more” to the judicial exception. The steps of obtaining the series of raw intensity outputs from a sequencing platform and obtaining at least one reference sequence were found by the Examiner to be well-understood, routine, conventional activities previously known to the industry. Ans. 5; 84 Fed. Reg. 56. Appellants do not purport to have invented sequencing, and prior art sequencing methods are disclosed in the Specification (e.g., Spec. ¶¶ 8–16). Thus, the Examiner’s finding is supported by a preponderance of the evidence. Summary For the foregoing reasons, the rejection of claim 53 as ineligible for a patent under 35 U.S.C. § 101 is affirmed. Claims 42–52 and 54–75 fall with claim 53. Appeal 2019-001691 Application 13/266,662 19 TIME PERIOD No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv). AFFIRMED Copy with citationCopy as parenthetical citation