KONINKLIJKE PHILIPS N.V.

Patent Trials and Appeals Board

Jan 3, 2022

2021002225 (P.T.A.B. Jan. 3, 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. 14/426,484 03/06/2015 Iain Chapple 2012P01480WOUS 2528 24737 7590 01/03/2022 PHILIPS INTELLECTUAL PROPERTY & STANDARDS 1600 Summer Street 5th Floor Stamford, CT 06905 EXAMINER WISE, OLIVIA M. ART UNIT PAPER NUMBER 1631 NOTIFICATION DATE DELIVERY MODE 01/03/2022 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): katelyn.mulroy@philips.com marianne.fox@philips.com patti.demichele@Philips.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte IAIN CHAPPLE, ANDREW CREESE, and MELISSA GRANT1 ____________ Appeal 2021-002225 Application 14/426,484 Technology Center 1600 ____________ Before ERIC B. GRIMES, JEFFREY N. FREDMAN, and JOHN G. NEW, Administrative Patent Judges. NEW, Administrative Patent Judge. DECISION ON APPEAL 1 We use the word “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42. Appellant identifies Koninklijke Philips N.V. as the real party-in-interest. App. Br. 3. Appeal 2021-002225 Application 14/426,484 2 SUMMARY Appellant files this appeal under 35 U.S.C. § 134(a) from the Examiner’s Final Rejection of claim 1 as unpatentable under 35 U.S.C. § 101 as being directed to nonstatutory subject matter. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. NATURE OF THE CLAIMED INVENTION Appellant’s claimed invention is directed to methods for diagnosing periodontitis, including selecting a set of protein biomarkers, one or more of which have been shown to vary in abundance at particular stages in the progression of periodontitis. Abstr. REPRESENTATIVE CLAIM Claim 1 is the sole claim on appeal and recites: 1. A method for diagnosing the status of periodontitis disease, consisting of: receiving a gingival crevicular fluid (GCF) sample and a saliva sample obtained from a patient; determining the expression levels of a set of protein biomarkers in the GCF sample, the set of protein biomarkers consisting of haemoglobin alpha chain, haemoglobin beta chain, carbonic anhydrase 1, and plastin-1; determining the expression levels of the set of protein biomarkers in the saliva sample; comparing the determined expression levels from the two samples to predetermined expression levels corresponding to a Appeal 2021-002225 Application 14/426,484 3 level of periodontitis disease, wherein the predetermined expression levels of the proteins in the set of protein biomarkers differ between a healthy state, a gingivitis state, and a periodontitis state; diagnosing, based on the comparison, a level of the patient’s periodontitis disease; and treating the patient’s periodontitis disease based on the diagnosed level of the patient’s periodontitis disease. App. Br. App’x A 23. ISSUES AND ANALYSIS We agree with, and adopt, the Examiner’s findings, reasoning, and conclusion that claim 1 is directed to nonstatutory subject matter. We address below the arguments raised by Appellant. Issue Appellant argues that the Examiner erred because claim 1 is focused on a specific improvement in the diagnosis and treatment of periodontitis in a patient, based upon a more convenient diagnosis of the disease. App. Br. 16. Analysis The Examiner finds that claim 1 is directed to non-statutory subject matter because the claimed invention recites an abstract idea and a law of nature without significantly more. Final Act. 3. Specifically, the Examienr finds that the “limitation of diagnosing the status of periodontitis disease based on a comparison of expression levels equates to a correlation between Appeal 2021-002225 Application 14/426,484 4 the expression levels of the set of proteins, which are natural products, and the status of periodontitis disease,” and are thus directed to a phenomenon of nature. Id. at 4. Additionally, the Examiner finds that the steps of determining expression levels, and of forming a diagnosis based upon the comparison of expressed levels against known values, equate to evaluations of data that can be performed in the human mind and thus recite a patent- ineligible mental process. Id. Appellant disputes the Examiner’s findings that the steps of determining expression levels of the biomarkers and diagnosing periodontitis “equate to evaluations of data that can be practically performed in the human mind,” that “comparing data to a reference for four biomarkers can be practically performed in the human mind,” and that “diagnosing the status of periodontitis disease … equates to a correlation between the expression levels of the set of proteins, which are natural products, and the status of periodontitis [].” App. Br. 16 (quoting Final Act. 4). Rather, argues Appellant, claim 1 is instead directed to a complex, multi-step process for diagnosing and treating a patient based on the analysis of periodontitis disease, which requires several different physical analyses. App. Br. 16. Appellant contends that the claimed method analyzes the proteome of a gingival crevicular fluid (“GCF”) sample and/or a saliva sample to generate a protein profile, determines the expression level of a specific plural set of biomarkers in the protein profile, and uses that protein profile to diagnose the status of a patient’s periodontitis by comparing the determined expression levels to predetermined expression levels corresponding to periodontitis. Id. Appeal 2021-002225 Application 14/426,484 5 Appellant emphasizes that it is not the relationship between the expression level of a biomarker and the status of a patient’s periodontitis that is claimed, rather it is the complex, multi-step process recited in claim 1. App. Br. 16. Appellant distinguishes claim 1 from the claims at issue in Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66 (2012) which were directed to a simple process of: (1) administering a drug; and (2) determining a level of a metabolite. Id. Appellant also points to Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals, 887 F.3d 1117 (Fed. Cir. 2018), in which the Federal Circuit held that claims comprising a practical application of an abstract idea such as a natural relationship are patent eligible under the first step of the framework first set forth in Alice Corp. Pty. Ltd. v. CLS Bank Intern., 573 U.S. 208 (2014), because they are not directed to an abstract idea; rather, they are directed to an application of the abstract idea. Id. at 16-17; see Vanda, 887 F.3d at 1135. Appellant asserts that claim 1 is directed to a method of treating periodontitis, which can potentially be diagnosed at much earlier stages than is possible without the method. Id. Appellant notes that practicing the claimed method can lead to significantly improved treatment outcomes, saving considerable time and expense. Id. Therefore, contends Appellant, claim 1 applies a relationship to generate a diagnosis that evaluates a status of a patient’s disease, rather than being directed to the relationship. App. Br. 17. Appellant asserts that this is similar to the distinction between the patent-ineligible claims in Mayo (directed to a relationship) and the patent-eligible claims in Vanda (applying a relationship). Id. Appeal 2021-002225 Application 14/426,484 6 Appellant next points to the United States Patent and Trademark Office’s 2019 Revised Patent Subject Matter Eligibility Guidance, 84(4) Fed. Reg. 50-57 (January 7, 2019) (the “2019 Guidance”) with regard to a “particular treatment or prophylaxis” integrating a judicial exception into a practical application. App. Br. 18. Appellant notes that the 2019 Guidance states that: In the context of revised Step 2A, the following exemplary considerations are indicative that an additional element (or combination of elements) may have integrated the exception into a practical application: … an additional element that applies or uses a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition. Id. (quoting 2019 Guidance, 55). Appellant argues that there is a treatment step recited in claim 1 that integrates the identified judicial exception into a “specific, tangible application.” App. Br. 18. Appellant likens this case to Classen Immunotherapies, Inc. v. Biogen IDEC, 659 F.3d 1057 (Fed. Cir. 2011), in which the practical application was a specific immunization treatment that was selected based on an identified judicial exception. Id. (see Classen, 659 F.3d at 1066-68). Appellant contends that, in the method of claim 1, the practical application is a specific treatment that is selected based on the identified judicial exception: “treating, based on the diagnosed status, the patient’s diagnosed periodontitis disease, wherein the patient is treated for a gingivitis state when there is a diagnosis of the gingivitis state, and further wherein the patient is treated for a mild periodontitis state when there is a diagnosis of the mild periodontitis state, and further wherein the patient is treated for a severe periodontitis state when there is a diagnosis of the severe periodontitis state.” Appeal 2021-002225 Application 14/426,484 7 Id. at 19. Therefore, argues Appellant, the “character as a whole” of claim 1 is not directed to an abstract idea or a law of nature, but to a specific novel and non-obvious method for treating diagnosed periodontitis. Id. Appellant next disputes the Examiner’s finding that the limitations of the claim “equate to well-understood, routine, and conventional activities both individually and in combination.” App. Br. 20 (quoting Final Act. 5). Rather, Appellant contends, the claimed invention constitutes numerous “additional features” in addition to those enumerated in the Office Action, including: (1) generating a proteome from the GCF sample and/or a saliva sample; (2) generating a protein profile from the generated proteome; (3) comparing the expression levels of the at least four different proteins in the protein profile to predetermined expression levels corresponding to periodontitis; (4) diagnosing the status of the patient’s disease, based on the comparison; and (5) treating the patient’s periodontitis disease. Id. Appellant asserts that the claimed method for treating diagnosed periodontitis produces an output that is tangible and immediately actionable, resulting in numerous applications such as the claimed treatment of the patient’s periodontitis. Id. Appellant contends that, subsequent to our reviewing court’s decision in Berkheimer v. HP Inc., 881 F.3d 1360 (Fed. Cir. 2018), a conclusion that an element or combination of elements is well-understood, routine and conventional requires either: (1) a “citation to an express statement in the specification or to a statement made by an applicant during prosecution that demonstrates the well-understood, routine, conventional nature of the additional element(s)”; (2) a “citation to one or more of the court decisions Appeal 2021-002225 Application 14/426,484 8 discussed in MPEP § 2106.05(d)(II) as noting the well-understood, routine, conventional nature of the additional element(s)”; or (3) a “citation to a publication that demonstrates the well-understood, routine, conventional nature of the additional element(s).” App. Br. 21 (quoting Patent Examining Corps Memorandum Re: Changes in Examination Procedure Pertaining to Subject Matter Eligibility, Recent Subject Matter Eligibility Decision (Berkheimer v. HP, Inc.), 19 April 2018. Appellant emphasizes that it is the combination of additional elements that must be defined as well-understood, routine, conventional activity. Id. Appellant contends that claim 1 represents an unconventional combination of elements within the same method. App. Br. 22. According to Appellant, it is unconventional, as shown by the lack of disclosure in the prior art, to obtain a protein profile from a saliva sample, and to obtain a protein profile from a GCF sample, and analyze these protein profiles (focusing on the expression levels of the four cited proteins) to determine a level of a patient’s oral disease for treatment. Id. at 23. We are not persuaded by Appellant’s arguments. In performing an analysis of patentability under Section 101, we follow the framework set forth by the Supreme Court in Mayo. We are also mindful of, and guided by, the 2019 Guidance. Appellant’s claim 1 recites: “A method for diagnosing the status of periodontitis disease, consisting of: ….” Following the first step of the Mayo analysis, we find that claim 1 is thus directed to a process or method, and therefore fall into one of the broad statutory categories of patent-eligible subject matter under 35 U.S.C. § 101. Appeal 2021-002225 Application 14/426,484 9 In the next step of the Mayo analysis, we determine whether the claims at issue are directed to a nonstatutory, patent-ineligible concept, i.e., a law of nature, a phenomenon of nature, or an abstract idea. Mayo, 566 U.S. at 70-71. If the claims are so directed, we next consider the elements of each claim both individually and “as an ordered combination” to determine whether additional elements “transform the nature of the claim” into a patent-eligible application. Id. at 78-79; see also Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371, 1375 (Fed. Cir. 2015). Specifically, the Supreme Court considered this second step as determining whether the claims recite 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.” Mayo, 566 U.S. at 72-73. More specifically, in this second step of the Mayo analysis, we look to whether the claim recites one of the judicially-created exceptions to Section 101, i.e., an abstract idea, a law of nature, or a natural phenomenon. See 2019 Guidance 54 (step 2A, prong 1). Claim 1 is directed to “A method for diagnosing the status of periodontitis disease,” and recites the following steps: (1) receiving a GCF sample and a saliva sample obtained from a patient; (2) determining the expression levels of a set of protein biomarkers in the GCF sample, the set of protein biomarkers consisting of hemoglobin alpha chain, hemoglobin beta chain, carbonic anhydrase 1, and plastin-1; (3) determining the expression levels of the set of protein biomarkers in the saliva sample; (4) comparing the determined expression levels from the two samples to predetermined expression levels corresponding to a level of periodontitis disease; (5) diagnosing, based on the comparison, a level of the patient’s periodontitis Appeal 2021-002225 Application 14/426,484 10 disease; and (6) treating the patient’s periodontitis disease based on the diagnosed level of the patient’s periodontitis disease. Put more succinctly, claim 1 is directed to a method of diagnosing whether a patient has periodontitis, and the level of the disease, based upon the quantitative expression of several protein biomarkers, and using the diagnosis to treat the periodontitis appropriately. The Examiner finds that claim 1 thus recites a law, or phenomenon, of nature (i.e., the relationship between biomarker expression and periodontitis), as well as the mental step of comparing the level of biomarker expression to the state of the periodontitis and consequently, recites one of the judicially-created exceptions to article 1. We agree. Appellant has discovered that that the expression of a set of four particular protein biomarkers “may be used to distinguish between a healthy state, gingivitis state, a mild state, and a severe state of periodontitis.” See Spec. 9. Because these biomarker proteins are expressed in a person with periodontitis, regardless of whether biomarkers are detected by testing, they are a natural expression of the disease and are consequently a phenomenon of nature. Claim 1 recites a method for observing the law of nature that expression levels of the claimed biomarkers correlate to periodontitis. See Cleveland Clinic Found. v. True Health Diagnostics LLC, 859 F.3d 1352, 1360 (Fed. Cir. 2017). As our reviewing court found in Cleveland Clinic: In Ariosa, the ineligible claims were directed to a method of detecting paternally inherited cell-free fetal DNA, which is naturally occurring in maternal blood. 788 F.3d at 1376. The inventors there did not create or alter any of the genetic information encoded in that DNA. Id. Likewise, here, the testing patents purport to detect MPO [myeloperoxidase] and other MPO-related products, which are naturally occurring in bodily Appeal 2021-002225 Application 14/426,484 11 samples. The method then employs the natural relationship between those MPO values and predetermined or control values to predict a patient’s risk of developing or having cardiovascular disease. Thus, just like Ariosa, the method starts and ends with naturally occurring phenomena with no meaningful non-routine steps in between-the presence of MPO in a bodily sample is correlated to its relationship to cardiovascular disease. The claims are therefore directed to a natural law. Id. at 1361. Having determined that claim 1 recites an abstract idea, we next determine whether the limitations reciting the judicial exception are integrated into a practical application. The Guidance provides additional context for this analysis, stating that: “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.” 2019 Guidance at 53. Appellant contends that claim 1 is directed to a method of treating periodontitis, which can be potentially diagnosed at much earlier stages than possible without the method, and therefore applies a relationship to generate a diagnosis that evaluates a status of a patient’s disease, rather than being directed to the relationship. See App. Br. 17. Appellant’s reliance upon Vanda in this context is, however, misplaced. In Vanda, the claims at issue required the specific steps of: (1) determining a patient’s CYP2D6 metabolizer genotype by (a) obtaining a biological sample, and (b) performing a genotyping assay; and (2) administering specific dose ranges of iloperidone depending on the patient’s CYP2D6 genotype. 887 F.3d at 1134. It is step (2) of this process that distinguishes the claims in Vanda Appeal 2021-002225 Application 14/426,484 12 from Appellant’s claim 1. Claim 1 recites “treating the patient’s periodontitis disease based on the diagnosed level of the patient’s periodontitis disease.” Neither claim 1 nor Appellant’s Specification recite or disclose any particular treatment for periodontitis; such treatments would undoubtedly be well known to a practitioner. However, as such, we do not find that Appellant’s claim recites a “particular treatment or prophylaxis” into which the recognition of the correlation between biomarker expression and periodontitis is integrated; rather, claim 1 directs the practitioner to choose a treatment from among those treatments that are well known in the art. Cf. KSR, 566 U.S. at 77-78 (“A patent, for example, could not simply recite a law of nature and then add the instruction ‘apply the law.’”). We find, rather, that Appellant’s claim 1 resembles the claims at issue in Cleveland Clinic, which is cited by the Examiner. See Final Act. 4. The claims in Cleveland Clinic were directed to a diagnostic method based upon the correlation between expression of myeloperoxidase (“MPO”) and the risk of developing cardiovascular disease. The Cleveland Clinic claims did not provide a specific, diagnosis-related treatment, such as those recited in the claims in Vanda. Our reviewing court found the Cleveland Clinic claims to be patent-ineligible, partly because the claims do not “create[ ] a new laboratory technique; rather, it uses well-known techniques to execute the claimed method.” 859 F.3d at 1361. Similarly, Appellant’s claim 1 does not recite any specific means or method for “determining the expression levels of a set of protein biomarkers in the GCF [and saliva] sample, the set of protein biomarkers consisting of haemoglobin alpha chain, haemoglobin beta chain, carbonic anhydrase 1, and plastin-1.” Claim 1 does not require, and Appellant’s Specification does Appeal 2021-002225 Application 14/426,484 13 not describe, any unconventional methods for determining the expression levels of the recited proteins. The Examiner has cited evidence showing that protein expression is routinely analyzed in saliva and gingival crevicular fluid samples. Final Action 5. Appellant has not cited evidence to the contrary. Thus, the evidence of record supports the Examiner’s finding that the “receiving” and “determining” steps of claim 1 “equate to well- understood, routine and conventional activities.” Id. In summary, the physical methods recited in Appellant’s claim 1 do not require a novel or specific way of performing the requisite analysis and treatment, nor does claim 1 require a particular treatment or prophylaxis, but only generally recites methods and treatments that would be well known to those of skill in the art. Indeed, claim 1 encompasses any method of analysis or treatment known to a skilled artisan. We consequently do not agree with Appellant that the abstract idea recited in claim 1 is integrated into a practical application. For the same reasons, we find that, considering the elements of Appellant’s claim 1, both individually and “as an ordered combination,” claim 1 recites no additional elements that “transform the nature of the claim” into a patent eligible application. Mayo, 566 U.S. at 78-79; 2019 Guidance at 56 (Step 2B). As in Cleveland Clinic, claim 1 is directed to a phenomenon of nature, and requires only general and well-known methods of analysis and treatment to perform its methods. Appellant points to Berkheimer, arguing that the Examiner has not adequately demonstrated that these methods are “well-understood, routine, conventional activity.” See App. Br. 21. The problem for Appellant is that the language of claim 1 requires no specific means of determining biomarker levels of expression or Appeal 2021-002225 Application 14/426,484 14 treatment of periodontitis: any means known to a practitioner of ordinary skill in the art would satisfy claim 1. In short, there is no specific method that the Examiner must show represents “well-understood, routine, conventional activity,” because any method of determining levels of biomarker expression or means of treating periodontitis known to a person of ordinary skill in the art would satisfy the requirements of claim 1. We consequently affirm the Examiner’s rejection of claim 1. CONCLUSION The rejection of claim 1 as unpatentable under 35 U.S.C. § 101 is affirmed. 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). AFFIRMED Claim(s) Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1 101 Eligibility 1