Makoto Watanabe et al.Download PDFPatent Trials and Appeals BoardAug 5, 201914852308 - (D) (P.T.A.B. Aug. 5, 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. 14/852,308 09/11/2015 Makoto Watanabe OKA-0320/DIV 5757 74384 7590 08/05/2019 Cheng Law Group, PLLC 1133 13th St. N.W. Suite C2 Washington, DC 20005 EXAMINER AEDER, SEAN E ART UNIT PAPER NUMBER 1642 MAIL DATE DELIVERY MODE 08/05/2019 PAPER 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. PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE _____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD _____________ Ex parte MAKOTO WATANABE, EIICHI MATSUO, NAOKI KANEKO, TOSHIYA MATSUBARA, OSAMU NISHIMURA, MASAKI MORI, HIDEO MATSUDA, SHIGETO SENO, and ICHIRO TAKEMASA _____________ Appeal 2018-004691 Application 14/852,308 Technology Center 1600 _____________ Before JEFFREY N. FREDMAN, JOHN G. NEW, and JAMIE T. WISZ, Administrative Patent Judges. FREDMAN, Administrative Patent Judge. DECISION ON APPEAL Appellants1,2 appeal under 35 U.S.C. § 134 from the Final Rejection of claims 5 and 9–14, which are all the claims pending in the present application. We have jurisdiction over the appeal under 35 U.S.C. § 6(b). We affirm. 1 Appellants identify Shimadzu Corporation and Osaka University as the real parties in interest. App. Br. 2. 2 We have considered and herein refer to the Specification of Sept. 11, 2015 (“Spec.”); Final Office Action of June 19, 2017 (“Final Act.”); Appeal Brief of Dec. 17, 2017 (“App. Br.”); Examiner’s Answer of Jan. 31, 2018 (“Ans.”), and Reply Brief of Mar. 30, 2018 (“Reply Br.”). Appeal 2018-004691 Application 14/852,308 2 CLAIMED SUBJECT MATTER “As typical colon cancer markers, Carcinoembryonic antigen-related cell adhesion molecule 5 (CEA) and Carbohydrate Antigen 19-9 (CA19-9) are known.” Spec. 1:21–23. The prior art “reports that Galectin-1, Galectin- 3, and Galectin 4 are effective as plasma markers for colon cancer.” Spec. 2:3–5. The present invention relates generally to techniques for “clinical diagnosis and screening of colon cancer” using a “multiplex colon cancer marker panel.” Spec. 1:13–15. Independent claim 5 is illustrative of the claims on appeal and recites: 5. A method of detecting colon cancer comprising the steps of: preparing a blood plasma sample by treating whole blood collected from an individual, measuring the blood plasma sample by an assay based on biospecific affinity or a quantitative mass spectrometry method to acquire respective measured values of five colon cancer markers of Carcinoembryonic antigen-related cell adhesion molecule 5, Carbohydrate antigen 19-9, Galectin-4, APEX nuclease, and Actin-related protein 2 in the blood plasma sample; normalizing the respective measured values of the five colon cancer markers sigmoidally based on an extreme-value distribution to derive respective probability scores of the five colon cancer markers and deriving an average of the probability scores; and detecting the presence or absence of the colon cancer for the individual based on whether the average of the probability scores is higher or lower than a criterion value for the five colon cancer markers. Appeal 2018-004691 Application 14/852,308 3 REJECTIONS ON APPEAL Claims 5 and 9–14 stand rejected under 35 U.S.C. § 101 as directed to judicial exceptions of abstract idea and law of nature. Final Act. 2–6. ANALYSIS Appellants appeal the Examiner’s rejection of claims 5 and 9–14 as ineligible subject matter under § 101. App. Br. 5–9. All of the rejected claims are argued together as a group. See App. Br. 9 (“claims 9–14 are allowable for the same reasons noted above with regard to claim 5”). As such, we select claim 5 as representative of the rejected claims, and we decide the appeal of the rejection of all of the rejected claims on the basis of claim 5. See 37 C.F.R. § 41.37(c)(1)(iv). In analyzing patent-eligibility questions under the judicial exceptions to 35 U.S.C. § 101, the Supreme Court instructs us to “first determine whether the claims at issue are directed to a patent-ineligible concept.” Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 573 U.S. 208, 218 (2014). The Court found that “[p]henomena of nature, though just discovered, mental processes, and abstract intellectual concepts are not patentable, as they are the basic tools of scientific and technological work.” Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 71 (2012) (quoting Gottschalk v. Benson, 409 U.S. 63, 67 (1972)). If the claims are determined to be directed to an ineligible concept we then move to a second step and “consider the elements of each claim both individually and ‘as an ordered combination’ to determine whether the additional elements ‘transform the nature of the claim’ into a patent-eligible application.” Alice at 217 (quoting Mayo, 566 U.S. at 97). Appeal 2018-004691 Application 14/852,308 4 In addition to this direction by the Supreme Court, the U.S. Patent and Trademark Office published revised guidance on the application of § 101. USPTO’s January 7, 2019 Memorandum, 2019 Revised Patent Subject Matter Eligibility Guidance (“2019 Guidance Memorandum”). Under this guidance, in step one of the Mayo/Alice framework, we first look to whether the claim recites: (Prong 1) any judicial exceptions, including “[l]aws of nature, natural phenomena, and abstract ideas,” (quoting Alice, 573 U.S. at 216) and/or 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) (Guidance Step 2A, Prong 1); and (Prong 2) additional elements that integrate the judicial exception into a practical application (see MPEP § 2106.05(a)-(c), (e)-(h)), i.e., considering the claim as a whole, does it impose a meaningful limit on the judicial exception so as to be more than a drafting effort to circumvent patent-ineligibility for a judicial exception. Furthermore, under the guidance, regarding step two of the Mayo/Alice framework, only if a claim is determined to (1) recite a judicial exception and (2) not integrate that exception into a practical application, do we then look 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. Appeal 2018-004691 Application 14/852,308 5 The Board is required to adhere to the 2019 Guidance as a matter of Office policy. Id. at 51.3 2019 Guidance Step 1 First, under “Step 1,” we consider whether the claimed subject matter falls within the four statutory categories set forth in § 101, namely “[p]rocess, machine, manufacture, or composition of matter.” 2019 Guidance 53–54; see 35 U.S.C. § 101. Claim 5 recites a “method” and, thus, falls within the “process” category. Consequently, we proceed to the next step of the analysis. 2019 Guidance Step 2A Prong 1 Second, under “Step 2A [] Prong One,” we evaluate “whether the claim recites a judicial exception, i.e., an abstract idea, a law of nature, or a natural phenomenon.” 2019 Guidance 54; see Alice, 573 U.S. at 216. The Examiner determined that the rejected claims recite a law of nature or natural phenomenon because they recite the natural phenomenon that “levels of recited markers mathematically correlate with [] the presence and absence of colon cancer.” Ans. 6. Additionally, the Examiner determined that the mathematical “normalizing step is merely an abstract idea. Ans. 6. We agree with these conclusions, and Appellants’ arguments to the contrary are unpersuasive for the following reasons. Appellants contend that the steps of claim 5 “do not recite or describe any recognized exception. [See, e.g.,] Mayo . . . (recited steps of 3 Although the Office Action at issue, as well as all the briefing for this appeal, was completed before the 2019 Guidance was issued, the 2019 Guidance “applies to all applications . . . filed before, on, or after January 7, 2019.” 2019 Guidance at 50. Appeal 2018-004691 Application 14/852,308 6 administering a drug to a patient and determining the resultant level of 6- thioguanine in the patient ‘are not themselves natural laws’).” App. Br. 6. Appellants further contend “in the present invention method, measured values of five specific colon cancer markers are transformed to respective probability scores. Accordingly, it is clear that the essential features of the invention of claim 5 are not directed to a natural product itself, an abstract idea or a natural phenomenon.” App. Br. 7. We find this argument unpersuasive because Mayo stated that the patents at issue “set forth laws of nature—namely, relationships between concentrations of certain metabolites in the blood and the likelihood that a dosage of a thiopurine drug will prove ineffective or cause harm.” Mayo, 566 U.S. at 77. Claim 5 also sets forth a natural relationship between the amounts of five colon cancer markers and the presence or absence of colon cancer in a patient. In the portion of Mayo referred to by Appellants regarding administering, determining, and wherein steps, Mayo explains that “[t]hese additional steps are not themselves natural laws but neither are they sufficient to transform the nature of the claim.” Id. at 78. Claim 5 is similar to the claim held to recite a law of nature in Cleveland Clinic Foundation v. True Health Diagnostics LLC, 859 F.3d 1352 (Fed. Cir. 2017). In that case, the Federal Circuit examined a claim to a method wherein the amount of “myeloperoxidase [(MPO)] in a bodily sample” is determined and compared to MPO levels in control subjects, which indicates “the extent of the test subject’s risk of having atherosclerotic cardiovascular disease.” Id. at 1356. Similarly, claim 5 recites, “detecting the presence or absence of the colon cancer,” and comparing that value to “whether the average of the probability scores is higher or lower than a Appeal 2018-004691 Application 14/852,308 7 criterion value for the five colon cancer markers,” which indicates whether the subject has “colon cancer.” Just as the Federal Circuit determined the claims in Cleveland Clinic to be directed to a natural law (i.e., the correlation between MPO and heart disease), we determine claim 5 here to recite a natural law, namely the correlation between five particular colon cancer markers and the presence or absence of colon cancer in a patient. See Cleveland Clinic, 859 F.3d at 1361. We also agree with the Examiner that claim 5 recites an abstract idea, specifically a mathematical concept. Specifically, as the Examiner found, claim 5 recites, “normalizing the respective measured values of the five colon cancer markers sigmoidally based on an extreme-value distribution to derive respective probability scores of the five colon cancer markers and deriving an average of the probability scores,” which is a mathematical analysis of the law of nature data. Final Act. 5. As such, claim 5 recites a mathematical concept, which is one of the three groupings of subject matter that the 2019 Guidance designates as meeting the abstract idea exception. 2019 Guidance 52. While the Federal Circuit has “recognize[d] that defining the precise abstract idea of patent claims in many cases is far from a ‘straightforward’ exercise.” Synopsys, Inc. v. Mentor Graphics Corp., 839 F.3d 1138, 1150 (Fed. Cir. 2016), the Federal Circuit explained that “we continue to ‘treat[] analyzing information by steps people [could] go through in their minds, or by mathematical algorithms, without more, as essentially mental processes within the abstract-idea category.’” Id. at 1146–47 (citation omitted). We find the mathematical concept in claim 5 is similar to that in SmartGene, where the Federal Circuit held that claims directed to Appeal 2018-004691 Application 14/852,308 8 “comparing new and stored information and using rules to identify medical options” did not satisfy Alice step one. See SmartGene, Inc. v. Advanced Biological Labs., SA, 555 F. App’x 950, 951–52, 955–56 (Fed. Cir. 2014) (nonprecedential). As in SmartGene, the “normalizing” and “deriving” steps do not rely on an inventive device or technique for displaying information or new techniques for obtaining biological information, but rather constitute a recitation of steps for mathematically manipulating data associated with a natural phenomenon. See SmartGene, 555 Fed. Appx. at 954 (holding claims were patent ineligible because they did “no more than call on a ‘computing device,’ with basic functionality for comparing stored and input data and rules, to do what doctors do routinely.”). 3. 2019 Guidance Step 2A Prong 2 Having determined that claim 5 recites a law of nature/natural phenomenon and a mathematical concept, we proceed to “Step 2A[] Prong Two” of the 2019 Guidance, which requires that we evaluate whether “the claim as a whole integrates the recited judicial exception into a practical application of that exception.” Id. at 54. “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.” Id.; see Mayo, 566 U.S. at 78. The 2019 Guidance specifies that this evaluation is conducted by first “[i]dentifying whether there are any additional elements recited in the claim beyond the judicial exception(s)”, then “evaluating those additional elements individually and in combination to determine whether they integrate the Appeal 2018-004691 Application 14/852,308 9 exception into a practical application.” 2019 Guidance 54–55. The Examiner determined that, aside from the recited judicial exceptions, claim 5 did not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements (common methods of detecting proteins) are routinely performed in the art to obtain data regarding protein levels. The claims do not recite something “significantly more” than the judicial exception(s); rather, the claims “simply inform” the natural phenomenon to one performing routine active method steps and do not amount to significantly more than the judicial exception(s). Final Act. 3. According to the Examiner, measuring CEACAM5, CA 19-9, LGALS4, APEX1, and ACTR2 by quantitative mass spectrometry was an established, common technique. Id. at 3. Further, the Examiner cited two references, Mackay4 and Spetzler,5 to establish that “measuring proteins in plasma samples using methods such as biospecific affinity assays” and that “detecting each recited marker in samples such as plasma and using either biospecific affinity or mass spectrometry techniques” were routine and conventional. Id. Based on the above, the Examiner concluded that the claim does not integrate the recited judicial exceptions into a practical application. Id. We agree even considering Appellants’ arguments, as explained further below. Step 2A Prong 2 of the 2019 Guidance is a change from prior guidance from the Office regarding § 101 that was in effect at the time 4 Mackay et al., Role of Serial Plasma C.E.A. Assays in Detection of Recurrent and Metastatic Colorectal Carcinomas, 4 British Medical J. 382– 385 (1974). 5 Spetzler et al., US 2014/0148350 A1, published May 29, 2014. Appeal 2018-004691 Application 14/852,308 10 Appellants submitted their briefing in this appeal. See 2019 Guidance 54 (“Prong Two represents a change from prior guidance.”). Nonetheless, as the 2019 Guidance applies to applications filed before it was issued (id. at 50), we consider arguments presented by Appellants addressing issues relevant to Step 2A Prong 2. Appellants contend claim 5 recites, “normalizing the respective measured values of the five colon cancer markers sigmoidally based on an extreme- value distribution to derive respective probability scores of the five colon cancer markers and deriving an average of the probability scores” and Applicant submits that this step, and more particularly, this step in combination with the measuring step of claim 5, is “significantly more” than a natural correlation between biomarkers and colon cancer diagnosis. App. Br. 8. We are not persuaded that the combination includes elements beyond the judicial exceptions. Step 2A Prong 2 requires that only “any additional elements recited in the claim beyond the judicial exception(s)” be considered. 2019 Guidance 54–55 (emphasis added). As discussed above, both the correlation between the five colon cancer markers and the presence or absence of colon cancer and the mathematical method of normalizing the correlation values are subject matter falling under judicial exceptions to § 101. Thus, the only remaining elements recited in claim 5 are “preparing a blood sample” and “measuring the blood plasma sample by an assay based on biospecific affinity or a quantitative mass spectrometry”. The Examiner expressly considered these elements, individually and in combination. Ans. 4–5. Appeal 2018-004691 Application 14/852,308 11 Appellants also contend that the “five markers have markedly different characteristics based on structure, function and/or properties than other product of nature, as demonstrated in Reference Example 3 in the present [S]pecification.” App. Br. 7. We find this unpersuasive because, as an initial matter, the relationship between these five markers and the presence or absence of colon cancer (i.e., the recited correlation) is not an additional element because it recites a natural law, as discussed above. Further, the Examiner found that determining CEACAM5, CA 19-9, LGALS4, APEX1, and ACTR2 levels using either bioaffinity or mass spectrometry methods as recited in claim 5 were established techniques, citing specific prior art literature including Mackay and Spetzler as evidence. Final Act. 3. Thus, the Examiner considered the combination of elements Appellants rely on, and Appellants do not explain why these findings are inadequate. Moreover, we note that “add[ing] insignificant extra-solution activity to the judicial exception” is insufficient to integrate the exception into a practical application (2019 Guidance 55). Data gathering steps typically constitute such insignificant extra-solution activity. See Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 79 (2012) (concluding that additional element of measuring metabolites of a drug administered to a patient was insignificant extra-solution activity); OIP Techs., Inc. v. Amazon.com, Inc., 788 F.3d 1359, 1363 (Fed. Cir. 2015) (holding that mere data gathering is insufficient to confer patent eligibility). Here, the “preparing” and “measuring” steps, including the recited bioaffinity or mass spectrometry methods, gather the data (i.e., determine levels of the five Appeal 2018-004691 Application 14/852,308 12 markers) necessary to conduct the recited comparing and correlating (i.e., the judicial exceptions). Moreover, “generally link[ing] the use of a judicial exception to a particular technological environment or field of use” is insufficient to integrate a judicial exception into a practical application. 2019 Guidance 55. See Parker v. Flook, 437 U.S. 584, 595 (1978) (determining that limiting an ineligible alarm limit calculation to specific process variables in a chemical process was insufficient for patent eligibility). In addition, we note that Appellants did not demonstrate error in the Examiner’s conclusion that “methods encompassed by the instant claims are well-known, routine, and conventional.” Final Act. 3. Nor did Appellants argue, much less demonstrate, that claim 5 “uses a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition,” implements or uses a judicial exception with “a particular machine or manufacture that is integral to the claim,” or “effects a transformation or reduction of a particular article to a different state or thing.” 2019 Guidance 55; see MPEP 2106.05(a)–(c), (e). For the above reasons, Appellants have not shown that the Examiner erred in concluding that claim 5 does not integrate the recited judicial exceptions into a practical application. 4. 2019 Guidance Step 2B Having concluded that claim 5 recites judicial exceptions but does not integrate them into a practical application—i.e., that the claim is “directed to” those exceptions (2019 Guidance 54)—we finally turn to whether the claim provides an “inventive concept,” i.e., whether the additional elements beyond the exceptions, individually and in combination, amount to Appeal 2018-004691 Application 14/852,308 13 “significantly more” than the exceptions themselves. Id. at 56. According to the 2019 Guidance, “[a]dd[ing] a specific limitation or combination of limitations that are not well-understood, routine, conventional activity in the field” may indicate an inventive concept is present. Id. Conversely, “simply append[ing] well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality,” typically indicates an inventive concept is absent. Id. As discussed above, the Examiner correctly determined that the only “additional” elements recited in claim 5 are the “preparing” and “measuring” steps. Final Act. 3. The Examiner further found that the “methods encompassed by the instant claims are well-known, routine, and conventional.” Id. Specifically, the Examiner found that claim 5 does “not recite something ‘significantly more’ than the judicial exception(s); rather, the claims ‘simply inform’ the natural phenomenon to one performing routine active method steps and do not amount to significantly more than the judicial exception(s)”. Ans. 4–5. In addition, the Examiner found that Even the instant specification acknowledges that mass spectrometry and biospecific affinity assays are routine and conventional in the art by disclosing: “The assay based on biospecific affinity is well-known to those skilled in the art [. . . ] an immunoassay is preferred [. . . . ]A specific protocol of the immunoassay can be easily selected by those skilled in the art [. . . . ]Alternatively, the colon cancer markers may be measured based on mass spectrometry. A method of mass spectrometry [. . . ]can be appropriately selected by those skilled in the art” ([see] pages 14[–]15 of the instant specification). Ans. 4. The Examiner also notes “the additional elements (common methods of detecting proteins) are routinely performed in the art to obtain Appeal 2018-004691 Application 14/852,308 14 data regarding protein levels.” Ans. 4. We agree and find Appellants’ arguments unpersuasive, as explained below. Appellants contend that in the normalizing step of the present invention, measured values of the specific five colon cancer markers are transformed to respective probability scores. This transformation of measured values of the specific five colon cancer markers to respective probability scores is not disclosed in the prior art and therefore, is not a well-known, conventional and routine step performed in the art. App. Br. 8. Appellants further contend “the essential features of the present invention (i.e., both the measuring step, and the subsequent normalizing step) are not well-understood, routine, conventional activities and amount to ‘significantly more’ than a natural correlation between biomarkers and colon cancer diagnosis.” App. Br. 9. We find these arguments unpersuasive for similar reasons as for Step 2A Prong 2. The addition of the abstract mathematical analysis of “normalizing” to the natural correlation of five colon cancer markers and colon cancer does not add significantly more because “[a]dding one abstract idea . . . to another abstract idea . . . does not render the claim non-abstract.” RecogniCorp, LLC v. Nintendo Co., 855 F.3d 1322, 1327 (Fed. Cir. 2017). “A claim directed to an abstract idea does not automatically become eligible merely by adding a mathematical formula. . . . The addition of a mathematical equation that simply changes the data into other forms of data cannot save it.” Id. at 1328. The mathematical analysis recited in claim 5 converts measured values of the five colon cancer markers into an average of probability scores. Appeal 2018-004691 Application 14/852,308 15 Appellants point to no additional steps that could not be performed mentally or without using a generic computer. The use of a generic computer to perform generic computer functions that are “well-understood, routine, conventional activit[ies]” previously known in the industry is not enough to transform the abstract idea into a patent-eligible invention. See Alice, 573 U.S. at 225–26. As noted above, the Examiner cited specific evidence to support the findings that the additional elements of claim 5 were well-understood, routine and conventional. See Final Act. 4–5. Moreover, we note the Specification itself states that the “assay based on biospecific affinity is well-known to those skilled in the art and is not particularly limited.” Spec. 14:9–11. According to the Specification, the “method of mass spectrometry is not particularly limited as long as it can perform quantitative analysis, and can be appropriately selected by those skilled in the art.” Spec. 15:7–10. The Specification, thus, supports the Examiner’s finding that the recited detection and quantitation of colon cancer markers using affinity assays or mass spectrometry was well-understood, routine and conventional. Thus, for the reasons explained above, we agree with the Examiner that claim 5 “simply appends well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality,” and, thus, fails to present an “inventive concept” because the claim does not recite additional elements that provide “significantly more” than the recited judicial exceptions. See 2019 Guidance 56. Therefore, we sustain the Examiner’s rejection of claim 5 as ineligible subject matter under § 101. As a result, we also sustain the rejection of claims 9–14 under § 101. See 37 C.F.R. § 41.37(c)(1)(iv). Appeal 2018-004691 Application 14/852,308 16 DECISION We affirm the Examiner’s rejection of claims 5 and 9–14 under 35 U.S.C. § 101. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). AFFIRMED Copy with citationCopy as parenthetical citation