BGI GENOMICS CO., LTD.

Patent Trials and Appeals Board

Jan 10, 2022

2021001654 (P.T.A.B. Jan. 10, 2022)

UNITED STATES PATENT AND TRADEMARK OFFICE UNITED STATES DEPARTMENT OF COMMERCE United States Patent and Trademark Office Address: COMMISSIONER FOR PATENTS P.O. Box 1450 Alexandria, Virginia 22313-1450 www.uspto.gov APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO. 15/329,148 01/25/2017 Fuman Jiang B192.0001US1 9655 27367 7590 01/10/2022 WESTMAN CHAMPLIN & KOEHLER, P.A. 121 South Eighth Street Suite 1100 Minneapolis, MN 55402 EXAMINER BRUSCA, JOHN S ART UNIT PAPER NUMBER 1631 NOTIFICATION DATE DELIVERY MODE 01/10/2022 ELECTRONIC Please find below and/or attached an Office communication concerning this application or proceeding. The time period for reply, if any, is set in the attached communication. Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the following e-mail address(es): docketing@wck.com tsorbel@wck.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte FUMAN JIANG, YUYING YUAN, WEI WANG, and YE YIN1 Appeal 2021-001654 Application 15/329,148 Technology Center 1600 Before ERIC B. GRIMES, TAWEN CHANG, and JOHN E. SCHNEIDER, Administrative Patent Judges. GRIMES, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134(a) involving claims to a method of determining the fraction of cell-free nucleic acids in a sample, which have been rejected as being ineligible for patenting. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. 1 Appellant identifies the real party in interest as BGI GENOMICS CO. LTD. Appeal Br. 3. “Appellant” refers to “applicant” as defined in 37 C.F.R. § 1.42. Appeal 2021-001654 Application 15/329,148 2 STATEMENT OF THE CASE The Specification states that “estimation of cancer-derived DNA in peripheral blood of patients with tumor and cell-free fetal DNA fraction in the plasma from the pregnant woman, i.e. determination of a fraction of cell- free nucleic acids from a predetermined source in a biological sample, is of great significance.” Spec. 1. “Studies have shown that cell-free fetal DNA fragments in maternal blood circulation, majority of which are shorter than 313 bp, are generally shorter than cell-free maternal DNA fragments.” Id. Based on this fact, the Specification describes a procedure for estimating cell-free fetal DNA fraction based on sequencing the plasma [sic] from the pregnant woman, and which method has wide applications and may be applied to cell- free DNA from different sources. For example, this method may also be used to estimate a cancer-derived DNA fraction in peripheral blood of a patient with tumor. Id. Claims 1-3, 6-8, 14-19, 38-43, and 77 are on appeal. Claim 1, reproduced below, is illustrative: 1. A method for determining a fraction of cell-free nucleic acids from a predetermined source in a biological sample, comprising: (i) performing sequencing on cell-free nucleic acids contained in the biological sample, so as to obtain a sequencing result consisting of a plurality of sequencing data; (ii) determining the number of the cell-free nucleic acids in a length falling into a predetermined range in the biological sample based on the sequencing result; and (iii) determining the fraction of cell-free nucleic acids from the predetermined source in the biological sample based on the number of the cell-free nucleic acids in the length falling Appeal 2021-001654 Application 15/329,148 3 into the predetermined range, wherein said predetermined range has been determined by the following steps: (a) acquiring a sequencing result for a plurality of control samples and determining lengths of the cell-free nucleic acids for the plurality of control samples in each of which the fraction of cell-free nucleic acids from the predetermined source is known; (b) setting a plurality of candidate length ranges, and determining the percentage of cell-free nucleic acids obtained from each of the plurality of control samples present in each candidate length range; (c) determining a correlation coefficient for each candidate length range based on the percentage of cell-free nucleic acids obtained from each of the plurality of control samples present in each candidate length range and the known fraction of cell-free nucleic acids from the predetermined source in each of the control samples; and (d) determining at least one candidate length range or a combination of the candidate length ranges as the predetermined range based on the maximum correlation coefficient. OPINION Claims 1-3, 6-8, 14-19, 38-43, and 77 stand rejected under 35 U.S.C. § 101 on the basis that “the claimed invention is directed to an abstract idea without significantly more.” Final Action2 3. The Examiner finds that independent claim 1 recites a mental process; specifically, “determining the number of sequence reads from a cell-free nucleic acid sample that are in a predetermined size range and using the size ranges of the sequence read data to determine the fraction of cell-free nucleic acids from a source.” Id. 2 Office Action mailed July 6, 2020. Appeal 2021-001654 Application 15/329,148 4 The Examiner also finds that “[t]his judicial exception is not integrated into a practical application because the additional element . . . of sequencing cell-free nucleic acids is a data gathering step.” Id. at 5. Finally, the Examiner finds that “[t]he claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional element . . . of sequencing cell-free nucleic acids is conventional.” Id. The Examiner cites Agarwal3 as evidence that “sequencing of cell-free DNA of samples from pregnant women was commercially available” before Appellant’s effective filing date. Id. Appellant argues that the claimed method is eligible for patenting because it represents a technical improvement in the field of non-invasive fetal testing. Appeal Br. 13-14, 16-18. Appellant also argues that the claims include additional elements that are unconventional; specifically, “a novel, advantageous strategy which is founded on establishing a length range which gives the maximum correlation coefficient with the fetal cell free DNA fraction.” Id. at 18-22. Appellant points to the Yuan Declaration4 as evidence of “the technical contribution and real-word [sic] benefits of the claimed invention as well as the unconventionality of the steps recited in the claimed methods.” Id. at 15. Principles of Law A. Section 101 An invention is patent-eligible if it claims a “new and useful process, machine, manufacture, or composition of matter.” 35 U.S.C. § 101. 3 Agarwal et al., “Commercial landscape of noninvasive prenatal testing in the United States,” Prenatal Diagnosis 33:521-531 (2013). 4 Declaration under 37 C.F.R. § 1.132 of Yuying Yuan, filed June 11, 2020. Appeal 2021-001654 Application 15/329,148 5 However, the U.S. Supreme Court has long interpreted 35 U.S.C. § 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). In determining whether a claim falls within an excluded category, we are guided by the Court’s two-part framework, described in Mayo and Alice. Id. 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 (“On their face, the claims before us are drawn to the concept of intermediated settlement, i.e., the use of a third party to mitigate settlement risk.”); see also Bilski v. Kappos, 561 U.S. 593, 611 (2010) (“Claims 1 and 4 in petitioners’ application explain the basic concept of hedging, or protecting against risk.”). Concepts determined to be abstract ideas, and thus patent ineligible, include certain methods of organizing human activity, such as fundamental economic practices (Alice, 573 U.S. at 219-20; Bilski, 561 U.S. at 611); mathematical formulas (Parker v. Flook, 437 U.S. 584, 594-95 (1978)); and mental processes (Gottschalk v. Benson, 409 U.S. 63, 67 (1972)). 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 water-proof cloth, vulcanizing India rubber, smelting ores” (id. at 182 n.7 (quoting Corning v. Burden, 56 U.S. 252, 267-68 (1854))); and manufacturing flour (Benson, 409 U.S. at 69 (citing Cochrane v. Deener, 94 U.S. 780, 785 (1876))). Appeal 2021-001654 Application 15/329,148 6 In Diehr, the claim at issue recited a mathematical formula, but the 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 187; 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.”). Having said that, the Court also indicated that a 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. (citation omitted) (citing Benson and Flook); see, 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. “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. (alterations in original) (quoting Mayo, 566 U.S. at 77). “[M]erely requir[ing] generic computer implementation[] fail[s] to transform that abstract idea into a patent-eligible invention.” Id. B. USPTO Section 101 Guidance In January 2019, the U.S. Patent and Trademark Office (USPTO) published revised guidance on the application of § 101. See 2019 Revised Appeal 2021-001654 Application 15/329,148 7 Patent Subject Matter Eligibility Guidance, 84 Fed. Reg. 50 (Jan. 7, 2019) (“Revised Guidance”).5 “All USPTO personnel are, as a matter of internal agency management, expected to follow the guidance.” Id. at 51; see also October 2019 Update at 1. Under the Revised Guidance and the October 2019 Update, 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 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. Rev. 08.2017, Jan. 2018)) (“Step 2A, Prong Two”).6 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: 5 In response to received public comments, the Office issued further guidance on October 17, 2019, clarifying the 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). 6 This evaluation is performed 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 Revised Guidance - Section III(A)(2), 84 Fed. Reg. 54-55. Appeal 2021-001654 Application 15/329,148 8 (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. Revised Guidance, 84 Fed. Reg. at 52-56. Revised Guidance Step 2A, Prong 1 Following the Revised Guidance, we first consider whether the claims, which on their face are directed to a statutory category of invention (a method), recite a judicial exception. The Revised Guidance identifies three groupings of subject matter included in the abstract idea exception, including “[m]ental processes-concepts performed in the human mind (including an observation, evaluation, judgment, opinion).” 84 Fed. Reg. at 52. Appellant does not separately argue the rejected claims. We select claim 1 as representative. 37 C.F.R. § 41.37(c)(1)(iv). Claim 1 recites the steps of: (ii) determining the number of the cell-free nucleic acids in a length falling into a predetermined range in the biological sample based on the sequencing result; and (iii) determining the fraction of cell-free nucleic acids from the predetermined source in the biological sample based on the number of the cell-free nucleic acids in the length falling into the predetermined range. We agree with the Examiner that these steps encompass abstract ideas in the category of mental processes. The Specification does not describe any Appeal 2021-001654 Application 15/329,148 9 particular steps that are required by the step of “determining the number of the cell-free nucleic acids in a length falling into a predetermined range.” The Specification simply states that “[t]he number of the cell-free nucleic acids in the length falling into the predetermined range in the biological sample is determined based on the sequencing result.” Spec. 20. While the Specification goes on to state that, “[i]n certain embodiments,” this step includes further steps (id.), claim 1 does not require those further steps. Thus, under the broadest reasonable interpretation, “determining the number of the cell-free nucleic acids in a length falling into a predetermined range” encompasses observing the sequencing data of step (i) and counting the number of cell-free nucleic acids having a length within a predetermined range. This step therefore recites a mental process. See 84 Fed. Reg. at 54 (mental processes include observation and evaluation). The Specification also does not describe any particular steps that are required by the step of “determining the fraction of cell-free nucleic acids from the predetermined source in the biological sample based on the number of the cell-free nucleic acids in the length falling into the predetermined range.” The Specification states that “[i]t is determined that the fraction of the cell-free nucleic acids from the predetermined source in the biological sample based on the number of the cell-free nucleic acids in the length falling into the predetermined range.” Spec. 20. The Specification provides no further disclosure regarding this step that would preclude carrying it out by dividing the number of cell-free nucleic acids having a length falling into a predetermined range by the total number of cell-free nucleic acids. Therefore, this step also recites a mental process. Appeal 2021-001654 Application 15/329,148 10 In summary, steps (ii) and (iii) of claim 1 can practically be performed in the human mind, and therefore recite an abstract idea in the category of mental processes. Revised Guidance Step 2A, Prong 2 Although claim 1 recites an abstract idea, it would still be patent- eligible if “the claim as a whole integrates the recited judicial exception into a practical application of the exception.” Revised Guidance, 84 Fed. Reg. at 54. The analysis of whether a claim integrates a judicial exception into a practical application includes “[i]dentifying whether there are any additional elements recited in the claim beyond the judicial exception(s)” and “evaluating those additional elements individually and in combination to determine whether they integrate the exception into a practical application.” Id. at 54-55. Here, claim 1 recites an initial step of “(i) performing sequencing on cell-free nucleic acids contained in the biological sample, so as to obtain a sequencing result consisting of a plurality of sequencing data.” The recited “sequencing” step, however, is the step required to gather the data for the mental processes subsequently recited in claim 1. The Specification does not disclose any particular sequencing procedure to be used in the claimed method. See Spec. 19. The Specification states that, “[i]n embodiments . . . , the cell-free nucleic acids in the biological sample are sequenced by paired-end sequencing, single-end sequencing or single molecule sequencing.” Id. at 19-20. The Specification, however, does not describe these procedures further, implying that they are known sequencing methods. See also id. at 38 (“The sequencing process was practiced strictly following the standard operating procedure of Complete Appeal 2021-001654 Application 15/329,148 11 Genomics Inc.”). The sequencing step recited in claim 1 therefore does not represent an improvement in technology. Thus, the “sequencing” step of claim 1 is merely data-gathering- insignificant extra-solution activity-and does not indicate that the recited abstract idea has been integrated into a practical application. See 84 Fed. Reg. at 55, n.31 (“insignificant extra-solution activity” includes “mere data gathering such as a step of obtaining information about credit card transactions”); see also Ultramercial, Inc. v. Hulu, LLC, 772 F.3d 709, 716 (Fed. Cir. 2014) (“‘[D]ata-gathering steps,’ CyberSource Corp. v. Retail Decisions, Inc., 654 F.3d 1366, 1370 (Fed. Cir. 2011), . . . add nothing of practical significance to the underlying abstract idea.”). Because claim 1 recites an abstract idea and does not integrate the abstract idea into a practical application, it is directed to an abstract idea. Revised Guidance Step 2(B) Finally, the Revised Guidance directs us to consider whether claim 1 includes “additional elements . . . [that] provide[] ‘significantly more’ than the recited judicial exception.” 84 Fed. Reg. at 56. The Revised Guidance states that an additional element that “simply appends well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, . . . is indicative that an inventive concept may not be present.” Id. Here, as discussed above, the additional element recited in claim 1, beyond the abstract idea to which it is directed, is the data-gathering step of “performing sequencing on cell-free nucleic acids.” The Examiner has cited Agarwal as “[e]vidence for the conventionality of sequencing cell-free nucleic acids from a pregnant woman.” Final Action 5. Appeal 2021-001654 Application 15/329,148 12 The Examiner finds that Agarwal’s “Table 1 [shows] that sequencing of cell-free [fetal] DNA of samples from pregnant women was commercially available . . . by October 2011.” Id. Describing its Table 1, Agarwal states: Four United States-based companies - Sequenom, Verinata Health (recently acquired by Illumina), Ariosa Diagnostics, and Natera - are marketing laboratory-developed tests that use a combination of polymerase chain reaction (PCR) and sequencing technologies and proprietary algorithms to analyze cffDNA for chromosomal aneuploidies (Table 1). Agarwal 522, right col. Agarwal’s Table 1 shows “Market Entry” dates between October 2011 and December 2012 for the four companies named in the quote above. Id., Table 1. Thus, the evidence of record supports the Examiner’s finding that the step of “performing sequencing on cell-free nucleic acids” was well- understood, routine, and conventional at the time of Appellant’s invention. See Revised Guidance, 84 Fed. Reg. at 56. In summary, the combination of elements recited in the method of claim 1 does not amount to significantly more than the judicial exception itself, and under 35 U.S.C. § 101 the claimed method is ineligible for patenting. Appellant’s Arguments Appellant argues that “the technology at issue here is . . . non-invasive fetal testing and the improvements to non-invasive fetal testing realized by the claimed method certainly amount to ‘something more.’” Appeal Br. 13. “That is, the methods result in providing accurate information to a parent of the fetus which can inform the remainder of a pregnancy. . . . The claimed methods improve the accuracy of the results . . . in a safer, non-invasive manner than prior art methods.” Id. at 14. Appellant points to the Yuan Appeal 2021-001654 Application 15/329,148 13 Declaration as evidence of “the technical contribution and real-word [sic] benefits of the claimed invention.” Id. at 15. Similarly, Appellant argues that “[c]laim 1 is . . . directed to an improved method for solving the problem: accurately determining the fraction of cell-free fetal nucleic acids in samples in the context of applying massively parallel sequencing, for example, in detecting a chromosomal aneuploidy in an in-utero fetus.” Id. at 16. Specifically, Appellant argues that the claimed method is an improvement in fetal testing because it can be applied to male and female fetuses, unlike the Y chromosome method, and does not rely on complicated and expensive SNP analysis. Id. at 17-18. This argument is unpersuasive because it is not directed to limitations of the claimed method. Claim 1 does not recite fetal testing or massively parallel sequencing; it recites “determining a fraction of cell-free nucleic acids from a predetermined source in a biological sample,” and none of the steps of the claimed method require cell-free fetal nucleic acids or a sample from a pregnant woman. The Specification’s definition of “a predetermined source” is not limited to a fetus, stating that “[i]n embodiments of the present disclosure, the cell-free nucleic acid from the predetermined source is selected from one of the following[]: cell-free fetal nucleic acids or maternal cell-free nucleic acids . . . , or cell-free tumor derived nucleic acids or cell-free non-tumor derived nucleic acids.” Spec. 2; see also id. at 19 (“[The] expression ‘fraction of cell-free nucleic acids from the predetermined source in a biological sample’ used herein refers to a fraction of the number of cell-free nucleic acids from specific source to the total number of cell-free nucleic acids in the biological sample.”). Appeal 2021-001654 Application 15/329,148 14 Thus, even assuming that the claimed method is useful in more cases than the Y chromosome method, and is simpler and cheaper than the SNP- based method, in determining the fraction of cell-free fetal DNA in a blood sample from a pregnant woman, Appellant’s argument does not show that the method of claim 1 is an improvement in the broadly defined process of determining a fraction of cell-free nucleic acids from a generic predetermined source found in any biological sample. In addition, Appellant alleges an improvement in identifying the subset of cell-free nucleic acids in a sample that come from a specific predetermined source (e.g., a fetus or a tumor), but the steps required by claim 1 are (i) determining the sequence (and thus the length) of cell-free nucleic acids in a sample, (ii) determining the number of nucleic acids with lengths within a certain range, and (iii) determining what proportion the number from step (ii) is compared to the total number from step (i). Appellant does not point to any alleged improvement in the process of sequencing cell-free nucleic acids (claim 1, step (i)), the process of counting cell-free nucleic acids of certain lengths (claim 1, step (ii)), or in dividing the number of cell-free nucleic acids of certain lengths by the total number of cell-free nucleic acids (claim 1, step (iii)). Rather, the improvement that Appellant alleges is in the process of identifying the length range of cell-free nucleic acids that correspond to those from a predetermined source. Appellant argues that “the improvements includ[e] the critical determined length range itself, such that the claims are neither conventional, routine, or well understood applications in the prior art.” Appeal Br. 14. Appellant argues that “selection of the pre-determined length range for the method of claim 1 requires the prior procedure of steps (a) to (d).” Id. at 19. Appeal 2021-001654 Application 15/329,148 15 “Once the predetermined length range is selected, for any sample under detection with unknown fraction steps (i) to (iii) are performed for determination of the fraction of cell-free fetal nucleic acids.” Id. at 19-20. Appellant argues that “the form of claim 1 is believed to clearly equate with the technical contribution to the art.” Id. at 21. Appellant also argues that, in one embodiment, the control samples are those in which the fetal DNA fraction was determined by the well-known chromosome Y method. . . . However, once the length range M was established providing maximal correlation between the percentage of cell-free nucleic acids in the range and pre- assessed fetal DNA fraction, the functional relationship could be applied in accordance with step (iii) regardless of sex of the fetus. Id. at 21. “This represents an important benefit over the chromosome Y method of non-invasive fetal testing.” Id. This argument is unpersuasive. First, the only active steps of claim 1-that is, the only steps needed to practice the claimed method-are steps (i), (ii), and (iii). Even Appellant refers to steps (a)-(d) as “the prior procedure.” Appeal Br. 19. Those steps merely define how the “predetermined range” recited in steps (i)-(iii) was previously determined. The “predetermined range” is nothing more than a range of nucleic acid lengths; e.g., 180 to 340 nucleotides. The process used to determine the length range does not change the processes of sequencing, counting, and dividing that are recited in steps (i)-(iii), which, again, are the only active steps required by the claimed process. In essence, Appellant’s claim 1 recites a product (the predetermined range of lengths) produced by a specific process (steps (a) through (d)). However, it is the product itself that must distinguish a claimed invention Appeal 2021-001654 Application 15/329,148 16 from the prior art, and there is no logical reason why nesting a product-by- process limitation in a method of analysis, like that of claim 1, should change how that limitation is evaluated. Cf. Biogen MA, Inc. v. EMD Serono, Inc., 976 F.3d 1326, 1334 (Fed. Cir. 2020) (“There is no logical reason why the nesting of a product-by-process limitation within a method of treatment claim should change how novelty of that limitation is evaluated.”). In addition, all of steps (a) through (d) appear to be capable of being done in the human mind or by a person with pen and paper. Step (a) requires “acquiring a sequencing result” and “determining lengths of the cell-free nucleic acids” for control samples. These substeps merely require observing a set of nucleic acid sequences (e.g., in a database) and noting their lengths. Step (b) requires “setting” candidate length ranges and “determining the percentage of cell-free nucleic acids” in those length ranges for the control samples. These substeps merely require conceiving of different length ranges and counting the number of nucleic acids in each range. Step (c) requires “determining” correlation coefficients for the candidate length ranges; Appellant has not alleged that correlation coefficients cannot be calculated manually with a pen and paper. Step (d) requires “determining” which length range or combination of ranges has the highest correlation coefficient, which merely requires deciding which range has the maximum correlation coefficient. Thus, to the extent that steps (a) through (d) are unconventional, we agree with the Examiner that such unconventionality is “within the judicial exception.” Ans. 3. Finally, Appellant points to the Yuan Declaration as evidence “showing . . . the unconventionality of the steps recited in the claimed Appeal 2021-001654 Application 15/329,148 17 methods.” Id. at 15. “The Declaration . . . is submitted in support of a showing that the additional elements claimed are unconventional.” Id. We have considered the Yuan Declaration but do not find it persuasive regarding the unconventionality of claim elements beyond the recited judicial exception. The Declaration provides a “[c]omparison with other four files” (Yuan Decl. 37), which we interpret as referring to four prior art publications. Three of those presumed publications, however, are identified only as “Jiang et al. (2012),” “Zimmerman et al. (2012),” and S.C.Y.YU et al. (2014)(D1).” Id. at 3-4. No citations are provided and the Declaration does not indicate if or when copies of the presumed publications were entered into the record. We decline to speculate on which references are intended or to comb through the record to try to find them. The last reference is accurately identified as WO2013132305A1. Again, however, the Declaration does not indicate if or when the reference was entered into the record. In addition, the Declaration simply lists purported differences between the overall method of the WO document and “our Patent,” and does not show that any of the elements of claim 1 beyond the judicial exception are not well-understood, routine, and conventional. In summary, we affirm the rejection of claim 1 under 35 U.S.C. § 101 as being directed to patent ineligible subject matter. Claims 2, 3, 6-8, 14-19, 38-43, and 77 fall with claim 1. 37 C.F.R. § 41.37(c)(1)(iv). 7 The pages of the Yuan Declaration are not numbered. We refer to the page with the declaration under 18 U.S.C. § 1001 as page 1 and the other pages are numbered consecutively. Appeal 2021-001654 Application 15/329,148 18 DECISION SUMMARY In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1-3, 6-8, 14-19, 38- 43, 77 101 Eligibility 1-3, 6-8, 14-19, 38- 43, 77 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