Katsuko Yamashita et al.Download PDFPatent Trials and Appeals BoardMay 4, 202013147905 - (D) (P.T.A.B. May. 4, 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. 13/147,905 08/04/2011 Katsuko Yamashita 092758-001600US-0817389 7245 20350 7590 05/04/2020 KILPATRICK TOWNSEND & STOCKTON LLP Mailstop: IP Docketing - 22 1100 Peachtree Street Suite 2800 Atlanta, GA 30309 EXAMINER DENT, ALANA HARRIS ART UNIT PAPER NUMBER 1643 NOTIFICATION DATE DELIVERY MODE 05/04/2020 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): KTSDocketing2@kilpatrick.foundationip.com ipefiling@kilpatricktownsend.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte KATSUKO YAMASHITA, KEIKO FUKUSHIMA, SHIRO BABA, and TAKEFUMI SATOH1 Appeal 2019-001489 Application 13/147,905 Technology Center 1600 Before ERIC B. GRIMES, FRANCISCO C. PRATS, and RACHEL H. TOWNSEND, Administrative Patent Judges. Opinion for the Board filed by Administrative Patent Judge GRIMES. Opinion Concurring filed by Administrative Patent Judge TOWNSEND. GRIMES, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134(a) involving claims to “a method for analyzing PSA (Prostate Specific Antigen)” (Spec. ¶ 1), which have been rejected as obvious and ineligible for patenting. We have jurisdiction under 35 U.S.C. § 6(b). We REVERSE. 1 Appellant identifies the real party in interest as Tokyo Institute of Technology. Appeal Br. 3. We use the word Appellant to refer to “applicant” as defined in 37 C.F.R. § 1.42(a). Appeal 2019-001489 Application 13/147,905 2 STATEMENT OF THE CASE The Specification states that “the PSA assay widely used is total PSA assay wherein both complexed PSA, in which PSA bound to α1- antichymotrypsin . . . , and free PSA can be measured.” Spec. ¶ 3. “The ratio of free PSA to total PSA is measured in order to distinguish prostate cancer from prostatic hypertrophy in patients exhibiting total PSA values in the gray zone” (i.e., total PSA in the range of 4–10 ng/mL). Id. ¶ 4. However, “even if the free/total PSA ratio is used, it is not easy to distinguish prostate cancer from prostatic hypertrophy.” Id. The Specification discloses that “serum PSA from most prostate cancer patients has β-N-acetylgalactosamine residues (GalNAcβ1→R).” Id. ¶ 11. The “invention relates to a method for analyzing PSA characterized in that a lectin having an affinity for β-N-acetylgalactosamine residues is brought into contact with a sample possibly containing PSA.” Id. ¶ 12. “According to a preferable embodiment . . . , the lectin is . . . Wisteria floribunda agglutinin.” Id. Claims 1, 3, and 23 are on appeal.2 Claims 1 and 23, reproduced below, are illustrative: 1. A method for analyzing PSA with a β-N- acetylgalactosamine residue, comprising the following step of: bringing into contact Wisteria floribunda agglutinin with a sample, which sample is a member selected from the group consisting of blood, serum, and plasma possibly containing PSA, wherein the amount of PSA is determined by measuring 2 The Examiner withdrew the rejections that had applied to claim 7. Ans. 3. Appeal 2019-001489 Application 13/147,905 3 total PSA or free PSA, to determine an amount of PSA having an affinity for Wisteria floribunda agglutinin. 23. A method for analyzing PSA having a β-N- acetylgalactosamine residue, the method comprising: contacting a sample with Wisteria floribunda agglutinin, wherein the sample is a member selected from the group consisting of blood, serum, and plasma possibly containing PSA; and determining an amount of PSA having an affinity for Wisteria floribunda agglutinin, wherein the amount of PSA having an affinity for Wisteria floribunda agglutinin is greater for PSA associated with prostate cancer than non-prostate cancer PSA. The claims stand rejected as follows: Claim 23 under 35 U.S.C. § 101 as being ineligible for patenting (Ans. 4) and Claims 1, 3, and 23 under 35 U.S.C. § 103(a) as obvious based on McMahon3 and Dwek4 (Ans. 5). OPINION Patent Eligibility Claim 23 stands rejected as being “directed to a judicial exception . . . without significantly more.” Ans. 4. The Examiner finds that [c]laim 23 is drawn to a non-statutory method having a “natural principle” as a limiting element or step. . . . [T]he “natural principle” is: detection of prostate specific antigen (PSA) with a 3 McMahon et al., Evaluation of three techniques for differential diagnosis of prostatic needle biopsy specimens, J. Clin. Pathol. 45:1094–98 (1992). 4 Dwek et al., GB2379444A, March 12, 2003. Appeal 2019-001489 Application 13/147,905 4 β-N-acetylgalactosamine residue in a sample using a Wisteria floribunda agglutinin (WFA) lectin correlates to prostate cancer diagnosis and a greater amount of PSA in a prostate cancer sample [as] opposed to a non-prostate cancer sample is indicative of prostate cancer. Id. The Examiner finds that “the active method steps are conventional and routine in the art . . . and the claims do not amount to significantly more than the recited natural principle.” Id. at 5. The Examiner concludes that “[t]he claims do not ‘practically apply’ the natural principle; rather, the claims ‘simply inform’ the natural principle to one performing routine active method steps and do not amount to significantly more than the natural principle itself.” Id. Specifically, “the outcome of the claimed method is only a statement of the natural correlation between detecting β-N- acetylgalactosamine residues with a WFA lectin in a patient’s sample indicates the presence of prostate cancer. Thus, the invention has not been practically applied.” Id. Appellant argues that “the natural principle of the present invention is: the relationship between levels of PSA with GalNAc in a sample and prostate cancer. That is, it is NOT a ‘natural principle’ to detect and measure PSA having β-GalNAc residues in a sample using Wisteria floribunda agglutinin (WFA) lectin.” Appeal Br. 20. Appellant argues that the correlation between prostate cancer PSA and WFA binding is not naturally occurring because “WFA naturally exists in a plant. Thus, a binding between the PSA with GalNAc in prostate cancer patients and WFA in plants cannot Appeal 2019-001489 Application 13/147,905 5 naturally occur at all.” Id. at 22. Finally, Appellant argues that “[u]sing WFA to detect and measure PSA is not routine” and the detection of the PSA having β-N-acetylgalactosamine residues through WFA, as taught and claimed, is significantly different from conventional detection methods. In the fields of clinical chemistry and in vitro diagnosis, PSA is generally detected by polyclonal antibodies and/or monoclonal antibodies binding to PSA. That is, the use of the polyclonal antibodies and monoclonal antibodies is conventional and routine. Id. 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. 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 Appeal 2019-001489 Application 13/147,905 6 in petitioners’ application explain the basic concept of hedging, or protecting against risk.”). If the claim is “directed to” a judicial exception—a law of nature, natural phenomenon, or 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 [judical exception] into a patent-eligible application.” Alice, 573 U.S. at 221 (quotation marks omitted). “If a law of nature is not patentable, then neither is a process reciting a law of nature, unless that process has additional features that provide practical assurance that the process is more than a drafting effort designed to monopolize the law of nature itself.” Mayo, 566 U.S. at 77. 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 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. 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). Appeal 2019-001489 Application 13/147,905 7 Under the Revised Guidance and the October 2019 Update, we first look to whether the claim recites: (1) any judicial exceptions, including an abstract idea (i.e., mathematical concepts, certain methods of organizing human activity, or mental processes), a law of nature, or a natural phenomenon (“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: (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 2(A), Prong 1 Following the Revised Guidance, we first consider whether claim 23 recites a judicial exception. Claim 23 recites “determining an amount of 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 2019-001489 Application 13/147,905 8 PSA [in a sample] having an affinity for Wisteria floribunda agglutinin, wherein the amount of PSA having an affinity for Wisteria floribunda agglutinin is greater for PSA associated with prostate cancer than non- prostate cancer PSA.” The Revised Guidance identifies “a law of nature, or a natural phenomenon” as being among the judicial exceptions to patentability. 84 Fed. Reg. at 54. Here, the property of PSA binding to Wisteria floribunda agglutinin (WFA) recited in the claim is not a natural phenomenon because, as Appellant has pointed out, the combination of PSA and WFA does not naturally occur. The naturally occurring phenomenon implicated by the claimed method is the increased presence of β-N-acetylgalactosamine residues on PSA from patients having prostate cancer. Claim 23, however, does not recite that correlation, nor is the claimed method generically directed to detecting that correlation; rather, the claim is limited to using WFA to detect specific binding between it and PSA. Increased binding between WFA and PSA from prostate cancer patients is not a naturally occurring phenomenon. We conclude that claim 23 does not recite a natural phenomenon, a law of nature, or any other judicial exception to patentability. Revised Guidance Step 2(A), Prong 2 Even if claim 23 was interpreted to recite a natural phenomenon, it would still be patent-eligible if “the claim as a whole integrates the recited judicial exception into a practical application of the exception.” 84 Fed. Reg. at 54. “A claim that integrates a recited judicial exception into a practical Appeal 2019-001489 Application 13/147,905 9 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. Here, as discussed above, claim 23 is limited to the use of Wisteria floribunda agglutinin (WFA) to detect the presence of β-N- acetylgalactosamine (GalNAc) residues on PSA. Thus, to the extent that claim 23 “recites” the natural phenomenon of increased GalNAc residues on PSA from prostate cancer patients, by requiring the use of WFA to assay for GalNAc on PSA, it “imposes a meaningful limit on the judicial exception” and makes the claim “more than a drafting effort designed to monopolize the” correlation between GalNAc and PSA from prostate cancer patients. See Revised Guidance, 84 Fed. Reg. at 54. We therefore conclude that, even if claim 23 recites a natural phenomenon, it integrates the judicial exception into a practical application. “When the exception is so integrated, then the claim is not directed to a judicial exception . . . and is eligible. This concludes the eligibility analysis.” Revised Guidance, 84 Fed. Reg. at 54. We reverse the rejection of claim 23 under 35 U.S.C. § 101. Obviousness Claims 1, 3, and 23 stand rejected as obvious based on McMahon and Dwek. The Examiner finds that “McMahon teaches ‘[f]ormalin fixed, paraffin wax embedded prostatic needle biopsy specimens of benign and malignant tissue were . . .’ contacted with Wisteria floribunda agglutinin Appeal 2019-001489 Application 13/147,905 10 (WFA).” Ans. 5. The Examiner finds that “McMahon does not teach the sample is blood and separating PSA bound by WFA and PSA not bound by WFA, as well as measuring free PSA (F) and total PSA (T).” Id. at 6. The Examiner finds, however, that “Dwek teaches purifying PSA (free and total) from a sample . . . including blood.” Id. The Examiner concludes that it would have been obvious to implement the lectin of McMahon in the method of Dwek to further assess binding affinities and specificities for the said residues within blood samples. . . . One of ordinary skill in the art would have been motivated to isolate PSA from the oligosaccharide linked to the PSA to detect any abnormal fucose content because it is art known fucosylation of PSA increases with cancerous conditions. Id. Appellant argues that “McMahon uses samples of cells of prostatic tissues (i.e., biopsy specimens). A prostatic tissue sample, as taught by McMahon, is entirely different from a blood sample, a serum sample, or a plasma sample, as taught and claimed.” Appeal Br. 12. “Furthermore, McMahon teaches away from the present invention. . . . McMahon explicitly states . . . that ‘Wisteria floribunda lectin seems to be unsuitable for further application in this context.’” Id. at 12–13. Appellant also argues that Dwek states that “[t]o maximize specificity of the test it is advantageous that the substance is tailored to detect an abnormal fucose content in the oligosaccharide linked to the PSA” . . . . Dwek does not teach or suggest analyzing PSA with a β-N-acetylgalactosamine residue. Moreover, Dwek describes using a fucose-specific binder. . . . The fucose-specific binders Appeal 2019-001489 Application 13/147,905 11 mentioned by Dwek are Ulex europaeus I (UEA-1) and Lotus tetragonolbus lectin. Id. at 13. We agree with Appellant that the cited references do not support a prima facie case of obviousness. McMahon investigated “whether . . . lectin histochemistry using Wisteria floribunda agglutinin . . . [is] of benefit in distinguishing between hyperplastic and carcinomatous prostatic glandular tissue in needle biopsy specimens.” McMahon 1094, abstract. McMahon found “90% WFA positivity in malignant tissue but also . . . mainly weak reactivity for WFA in 56% of benign glands. While demonstrating excellent sensitivity, this technique lacks specificity and alone cannot be recommended for diagnostic use.” Id. at 1097. McMahon concluded that “Wisteria floribunda lectin seems to be unsuitable for further application in this context.” Id. at 1098. Dwek discloses that “PSA expressed by cancerous prostate glands exhibits a higher, detectable level of fucose than normal PSA.” Dwek 4. Thus, “fucosylation of PSA apparently increases with cancerous conditions . . . and is exceptionally useful in assuring early detection of cancer.” Id. Dwek states that “blood is the easiest to sample and assay.” Id. at 5. Dwek states that “[a]ny suitable substance may be used as the fucose-specific binder. . . . For example, a lectin such as Ulex europaeus I (UEA-1), isolated from gorse, or Lotus tetragonolobus lectin, isolated from winged peas, may be used to identify fucose moieties within the oligosaccharide.” Id. at 7. Thus, McMahon assayed prostatic glandular tissue, not PSA, for Wisteria floribunda agglutinin (WFA) binding, and concluded that WFA Appeal 2019-001489 Application 13/147,905 12 was unsuitable for distinguishing between benign and malignant tissue samples. Dwek, on the other hand, analyzed fucosylation of PSA using a fucose-binding lectin such as Ulex europaeus I lectin or Lotus tetragonolobus lectin. The Examiner has stated that “WFA is art known to have binding affinity for β3-N-acetylgalactosamine residues and fucose α(λ,2) [sic, α(1, 2)?] galactose residues.” Ans. 5. The Examiner has not, however, pointed to evidence in the record showing that WFA binds to fucose residues. Appellant’s Specification states that WFA binds to β-N- acetylgalactosamine residues, and “lectin[s] having an affinity for the fucose α(1, 2) galactose residues include[] . . . UEA-I or TJA-II,” but not WFA. Spec. ¶¶ 20, 21. See also Appeal Br. Exhibit A,7 ¶ 6 (“Included herein is data showing that WFA binds to β-N-acetylgalactosamine residues, but does not bind fucose α(1, 2) galactose residues.”). Thus, the evidence of record does not support the Examiner’s conclusion that it would have been obvious to use McMahon’s WFA in Dwek’s assay to detect fucosylation. The Examiner has also not pointed to evidence in the record that would lead a skilled artisan to reasonably expect WFA to be effective in Dwek’s PSA-based assay despite WFA’s unsuitability for assaying prostatic tissue. “Motivation to combine is a factual determination as to whether there is a known reason a skilled artisan would have been motivated to combine elements to arrive at a claimed combination.” Arctic Cat, Inc. v. Bombardier 7 Declaration under 37 CFR § 1.132 of Katsuko Yamashita, signed August 2, 2016. Appeal 2019-001489 Application 13/147,905 13 Recreational Prods., Inc., 876 F.3d 1350, 1359 (Fed. Cir. 2017). Here, the evidence of record does not support the Examiner’s conclusion that it would have been obvious to combine the teachings of McMahon and Dwek. We therefore reverse the rejection of claims 1, 3, and 23 under 35 U.S.C. § 103 based on McMahon and Dwek. DECISION SUMMARY In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 23 101 Eligibility 23 1, 3, 23 103(a) McMahon, Dwek 1, 3, 23 Overall Outcome 1, 3, 23 REVERSED Appeal 2019-001489 Application 13/147,905 TOWNSEND, Administrative Patent Judge, concurring. I concur with my colleagues that the Examiner’s rejections should be reversed. In my view, however, the rejection of claim 23 under 35 U.S.C. § 101 should be reversed under Revised Step 2B of the 2019 Revised Patent Subject Matter Eligibility Guidance, 84 Fed. Reg. 50 (January 7, 2019) (“Guidance”). Guidance STEP 2A, Prong One: My colleagues determine that Appellant’s claim 23 is not directed to a non-statutory, patent-ineligible concept because it does not recite a law of nature, a phenomenon of nature, or an abstract idea. I disagree. Even Appellant acknowledges that the claims involve a natural correlation “the relationship between levels of PSA with GalNAC in a sample and prostate cancer.” (Appeal Br. 20. ) Appellant’s argument that “it is NOT a ‘natural principle’ to detect and measure PSA having β-GalNAc residues in a sample using Wisteria floribunda agglutinin (WFA) lectin” (Appeal Br. 20) because WFA does not exist naturally in humans (id. at 22), does not overcome the fact that what is being analyzed in the sample is the presence of PSA having β-GalNAc, which is indicative of prostate cancer. Appellant’s Specification explains that “[i]t is known that PSA is a glycoprotein having one asparagine-linked carbohydrate chain (hereinafter referred to as an N-glycan chain), and PSA from prostate cancer patients has a higher-branched complex type of N-glycans.” (Spec. 3.) Appellant in conducting “research on the determination of the carbohydrate structures expressed on PSA from prostate cancer patient serum using combinations of 14 Appeal 2019-001489 Application 13/147,905 various plant lectins having different carbohydrate binding abilities” found that “serum PSA from most prostate cancer patients has β-N- acetylgalactosamine residues (GalNAcβ1→R) and/or fucose α(1, 2) galactose residues (Fucα1→2Galβ1→R).” (Id. at 5.) Appellant further found that WFA has an affinity for β-N-acetylgalactosamine residues (GalNAcβ1→R) (id. at 11) and thus WFA is able to detect PSA from prostate cancer patients (id. at 26). Consequently, Appellant’s claim, which claims “[a] method for analyzing PSA with a β-N-acetylgalactosamine residue” by “bringing into contact” WFA with a blood sample and “determining the amount of PSA having an affinity for [WSA], wherein the amount of PSA having an affinity for [WFA] is greater for PSA associated with prostate cancer than non-prostate cancer PSA” effectively is a method “for diagnosis of prostate cancer.” (See id. at 9 (“A method for analyzing PSA according to a preferable embodiment of the present invention is for diagnosis of prostate cancer.”); see also id. at 26: It is considered that the change of the sugar chain structure of PSA with canceration, i.e., appearance of a fucose α(l, 2) galactose residue, a β-N-acetylgalactosamine residue and a sialic acid α(2, 6) β-N-acetylgalactosamine residue has a background of the changes of glycosyltransferase activities, which are associated with the sugar chain synthesis by the onset of the prostate cancer.) (emphasis added). That the claim itself does not specifically state that the analysis of the sample results in a diagnosis of prostate cancer does not change the fact that such is accomplished by the claimed analysis. As the Supreme Court “warns . . . patent eligibility [should not] ‘depend simply on the draftsman’s art’ without reference to the ‘prinicples underlying the prohibition against 15 Appeal 2019-001489 Application 13/147,905 patents for [natural laws.]’” Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 72 (2012) (second alteration in the original). I conclude Appellant’s claim 23 is much like the claim at issue in Athena Diagnostics Inc. v. Mayo Collaborative Servs., LLC, 915 F.3d 743 (Fed. Cir. 2019). In particular, at issue in Athena was a method for diagnosing neurotransmission or developmental disorders related to MuSK in a mammal, the method “comprising the step of detecting in a bodily fluid of said mammal autoantibodies to an epitope of [MuSK]” (Claim 1) which involved contacting MuSK or an epitope or antigenic determinant thereof having a suitable label thereon, with said bodily fluid, immunoprecipitating any antibody/MuSK complex or antibody/MuSK epitope or antigenic determinant complex from said bodily fluid and monitoring for said label on any of said antibody/MuSK complex or antibody/MuSK epitope or antigen determinant complex, wherein the presence of said label is indicative [that] said mammal is suffering from said neurotransmission or developmental disorder related to [MuSK]. 915 F.3d at 747 (Claim 7). In Athena, the law of nature was the “correlation between the presence of naturally-occurring MuSK autoantibodies in bodily fluid and MuSK related neurological diseases like MG.” Id. at 750. The Federal Circuit explained that “[t]his correlation exists in nature apart from any human action.” Id. Similarly, here, the correlation between the presence of PSA with β- N-acetylgalactosamine residues in the sample and prostate cancer exists 16 Appeal 2019-001489 Application 13/147,905 apart from any human action. Claim 23 recites “A method for analyzing PSA with a β-N-acetylgalactosamine residue . . . wherein the amount of PSA having an affinity for [WFA] is greater for PSA associated with prostate cancer than non-prostate cancer PSA” whereas the claims in Athena specifically recited diagnosing disorders related to MuSK in a mammal. However, I find this to be a distinction without a difference because, as already noted, the detection of the specific PSA recited is indicative of prostate cancer, as clearly indicated in claim 23’s wherein clause. The steps to assess the presence of the PSA having a β-N- acetylgalactosamine residue, of course, require human action, just as they did in Athena. Moreover, just as in Athena, the steps involve the use of a binding partner of the natural product in order to determine the presence of the natural product that is indicative of the correlation. The presence of these steps that require human action do not overcome the fact that a natural law is stated by the claim, just as they did not in Athena. Even if claim 23 was not considered to recite the natural correlation between PSA with β-N-acetylgalactosamine residues in the sample and the existence of prostate cancer, the claim at a minimum recites a natural phenomenon, the existence of PSA with β-N-acetylgalactosamine residues in sample from a patient with prostate cancer. See Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371, 1376 (Fed. Cir. 2015) (finding claims to detecting paternally inherited nucleic acid of fetal origin performed on a maternal serum or plasma sample from a pregnant female recited a natural phenomenon of the existence and location of the fetal DNA in the sample); see also Illumina, Inc. v. Ariosa Diagnostics, Inc., 952 F.3d 1367, 1373 17 Appeal 2019-001489 Application 13/147,905 (Fed. Cir. 2020) (“In essence, the inventors in Ariosa discovered that cell- free fetal DNA exists, and then obtained patent claims that covered only the knowledge that it exists and a method to see that it exists.). Guidance STEP 2A, Prong Two: Having made the determination that claim 23 recites a natural law (i.e., a natural correlation/natural phenomenon), under the Guidance, I next examine whether there are additional elements beyond the natural law that integrate the judicial exception into a practical application. Guidance, 84 Fed. Reg. at 54-55. That is, under the Prong Two analysis, I look to whether the claim as a whole “appl[ies], rel[ies] on, or use[s] the judicial exception in a manner that imposes a meaningful limit on the judicial exception.” Id. This step “specifically excludes consideration of whether the additional elements represent well-understood, routine, conventional activity.” Guidance, 84 Fed. Reg. at 55. Here, I again depart from my colleagues’ analysis. The additional limitation of claim 23 is contacting the sample with a binding partner. This activity is not a practical application of the judicial exception. Rather it is pre-solution activity in that it is a data gathering step. The method begins with having a biological sample and ends with detecting PSA with β-N-acetylgalactosamine residues in that sample. The method does not require that any action be taken if the PSA with β-N- acetylgalactosamine residues is detected. Like the claims in Ariosa and Athena, the method begins and ends with the natural correlation/natural phenomenon. Ariosa, 788 F.3d at 1376; see also Mayo, 566 U.S. at 79–80 18 Appeal 2019-001489 Application 13/147,905 (claims ineligible where they “simply tell doctors to gather data from which they may draw an inference in light of the correlations”). While a concrete step is undertaken in the method, it is only done so as to observe the operation of the natural correlation/natural phenomenon. See Athena, 915 F.3d at 751. Accordingly, I conclude that the claim 23 does not integrate the natural law into a practical application. Guidance Step 2B I next determine whether claim 23 adds specific limitation(s) beyond the judicial exception that are not “well-understood, routine, conventional activity in the field” (see MPEP § 2106.05(d)), or whether they simply append well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception. See Guidance, 84 Fed. Reg. at 56. Here, I note that Appellant argues that “[u]sing WFA to detect and measure PSA is not routine” and the detection of the PSA having β-N-acetylgalactosamine residues through WFA, as taught and claimed, is significantly different from conventional detection methods. In the fields of clinical chemistry and in vitro diagnosis, PSA is generally detected by polyclonal antibodies and/or monoclonal antibodies binding to PSA. That is, the use of the polyclonal antibodies and monoclonal antibodies is conventional and routine. Appeal Br. 22. Although these claims undertake a binding step to detect the analyte of interest, which I determined under step 2A, prong two was insignificant pre-solution activity, and which, in the abstract, is a conventional step in biological sample analysis, I agree with Appellant that 19 Appeal 2019-001489 Application 13/147,905 20 the binding partner required to be used in Appellant’s method has not been established by the Examiner to be one that is conventionally used to detect PSA that is indicative of prostate cancer. For this reason, I agree with my colleagues that the claims on appeal amount to significantly more than the recited exception. Thus, I would reverse the Examiner’s rejection at Step 2B of the Guidance. Copy with citationCopy as parenthetical citation