Robert Bosch GmbHDownload PDFPatent Trials and Appeals BoardMay 26, 20212020004751 (P.T.A.B. May. 26, 2021) 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. 14/173,461 02/05/2014 Sam Kavusi 1576-0638CNT1 1259 10800 7590 05/26/2021 Maginot, Moore & Beck LLP One Indiana Square, Suite 2200 Indianapolis, IN 46204 EXAMINER MARCSISIN, ELLEN JEAN ART UNIT PAPER NUMBER 1641 MAIL DATE DELIVERY MODE 05/26/2021 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 SAM KAVUSI, MICHAELA LAUPHEIMER, and CHRISTOPH LANG1 Appeal 2020-004751 Application 14/173,461 Technology Center 1600 Before ERIC B. GRIMES, ROBERT A. POLLOCK, 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 quantitating a molecule of interest, which have been rejected as being directed to patent ineligible subject matter. We have jurisdiction under 35 U.S.C. § 6(b). We REVERSE. 1 Appellant identifies the real party in interest as Robert Bosch GmbH. Appeal Br. 2. We use the word “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42. Appeal 2020-004751 Application 14/173,461 2 STATEMENT OF THE CASE The “invention relates to diagnostic tests and more specifically to affinity based diagnostic tests.” Spec. ¶ 1. Such tests include ELISA plates and microarrays, the quality of which can be assessed using “Limit of Quantitation (LoQ) analysis.” Id. ¶¶ 4, 6. “The LoQ metric includes both an upper limit and a lower limit,” which “are the highest and lowest concentrations, respectively, that can be quantitatively measured within an acceptable total error for the particular assay.” Id. ¶ 7. “The range of concentrations between the lower LoQ and the upper LoQ for a particular assay is the dynamic range of the assay.” Id. ¶ 8. “Given a particular concentration of affinity probe molecules, the normalized signal obtained from a particular assay does not vary linearly with the concentration of the analyte of interest,” but instead follows an S-shaped “response curve,” which “is a curve showing the relationship between various concentrations of a molecule of interest in a plurality of samples and a plurality of quantitation signals obtained from the plurality of samples for a particular assay.” Id. ¶ 9. A typical response curve provides a dynamic range covering concentrations varying by “about two orders of magnitude.” Id. The Specification discloses a method in which “environment control equipment 114 is configured to establish and maintain environmental conditions, in this example, within a microarray 120.” Id. ¶ 33. “[T]he environment within each of the selected set of test sites 124 is controlled to establish, within each of the selected set of test sites 124, a different test Appeal 2020-004751 Application 14/173,461 3 environment.” Id. ¶ 39. As a result, each of the test sites is associated with a different response curve. Id. ¶¶ 33, 37. The Specification states that “a combined response curve” is generated “when the response curves for two sites with different test environments are summed.” Id. ¶ 25. “Thus, quantitation of samples within the concentration range of interest, which extends from the minimum concentration 182 to the maximum concentration 184, is possible by summing the signals obtained from the test sites 124 associated with the response curves 186 and 192.” Id. ¶ 46 (referring to Fig. 8). The combined response curve extends the dynamic range of analyte concentrations that can be assayed using a single microarray. Id. ¶¶ 16–17, Fig. 8. Claims 1–6, 9, 10, and 12–17 are on appeal. Claim 1,2 reproduced below, is illustrative: 1. A method of quantitating the concentration of a molecule of interest by extending the dynamic range of an array, comprising: establishing a first test environment at a first test site of an array and a second test environment at a second test site of the array using an environment control device, each of the first and second test environments (i) including at least one first probe molecule which is identical to a probe molecule provided in the other of the first and second test environments, and (ii) associated with one of a plurality of response curves, each of the plurality of response curves different from the other of the plurality of response curves; identifying, for each of the first and second test sites, the associated one of the plurality of response curves, wherein each 2 The claim language reproduced above includes Appellant’s amendment filed Dec. 17, 2019, which was entered by the Examiner. See Adv. Action mailed Dec. 31, 2019. Appeal 2020-004751 Application 14/173,461 4 of the identified associated response curves is different from the other of the identified associated response curves; storing a combined response curve resulting from a summation of the identified associated response curves; exposing each of the first and second of test sites to a sample having a concentration of the molecule of interest such that the concentration of the molecule of interest is the same at each of the first and second test sites; binding a first number of the molecules of interest from the sample at the first test site while the first test site is established at the first test environment; binding a second number of the molecules of interest from the sample at the second test site while the second test site is established at the second test environment, the second number different from the first number; obtaining a first quantitation signal associated with the bound first number of molecules of interest using a label reader; obtaining a second quantitation signal associated with the bound second number of molecules of interest using a label reader; summing the first and second quantitation signals; associating the summation of the first and second quantitation signals with the stored combined response curve; and determining the concentration of the molecule of interest in the sample based upon the association. Claim 12 is the other independent claim and is directed to the same method defined in claim 1, using slightly different claim language. Appeal 2020-004751 Application 14/173,461 5 OPINION Claims 1–6, 9, 10, and 12–17 stand rejected under 35 U.S.C. § 101 on the basis that “the claimed invention . . . is directed to abstract ideas without significantly more.” Ans. 3. The Examiner finds that “the steps of identifying, associating, and determining are mental processes, namely concepts performed in the human mind.” Id. at 4. The Examiner also finds that the “steps of storing a combined response curve and obtaining a first and a second quantification signal, summing the signals are each abstract ideas as they are directed to mathematical concepts.” Id. at 4–5. Finally, the Examiner finds that, “[r]egarding the first step, the ‘establishing’ step . . . the limitation ‘associated with one of plurality of response curves’ amounts to associating each test site with a response curve . . . , which is an abstract idea, as it is considered a mental process.” Id. at 5. The Examiner finds that “[t]hese judicial exceptions are not integrated into a practical application” because, first, “[t]he step of ‘establishing a respective test environment’ at each of the first and second test sites is recited at a high level of generality,” and “‘an environment control device’ could be any generic component, including for example any device that would control environment.” Id. at 5. In addition, the Examiner finds that both the “establishing” and “exposing” steps are “mere data gathering.” Id. at 6. The Examiner finds that “[t]hese active wet method steps fail to indicate integration into practical application; for example, there is no indication that these steps improve the functioning of a computer or other technology,” etc. Id. Appeal 2020-004751 Application 14/173,461 6 Finally, the Examiner finds that “[t]he claim(s) do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additionally recited active method step (exposing the plurality of test sites to a sample having concentration of the molecule of interest) is mere insignificant extra solution activity.” Id. The Examiner also finds that the “exposing” step “is also not performed in an unconventional way, and as such fails to provide an ‘inventive concept’ that could render the claim patent eligible under 35 U.S.C. 101.” Id. at 6–7 (citing Dufva3 as “teach[ing] establishing multiple respective test environments at a plurality of test sites”). The Examiner also finds that the “label reader” recited in the claims is “routine and conventional in the art.” Id. at 7 (citing Dufva’s disclosure of a “means for detecting signal”). The Examiner concludes that “when considered both individually and as an ordered combination, the additional elements fail to amount to significantly more than the abstract ideas.” Id. Appellant argues, among other things, that the claimed method is an improved affinity based technological process for quantitating a concentration of a molecule of interest using a single sample and a single probe molecule that varies the manner in which affinity data is generated so that a single probe molecule can provide an extended dynamic range for the affinity based technological process for quantitating a concentration of a molecule of interest in a single sample. Appeal Br. 22. 3 Dufva et al., US 2010/0190265 A1, published July 29, 2010. Appeal 2020-004751 Application 14/173,461 7 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 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 Appeal 2020-004751 Application 14/173,461 8 (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))). 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 Appeal 2020-004751 Application 14/173,461 9 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 Patent Subject Matter Eligibility Guidance, 84 Fed. Reg. 50 (Jan. 7, 2019) (“Revised Guidance”).4 “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”).5 4 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). 5 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 Appeal 2020-004751 Application 14/173,461 10 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 2A, Prong 1 Following the Revised Guidance, we first consider whether the claims 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. Claim 1 recites the steps of: associating the summation of the first and second quantitation signals with the stored combined response curve; and determining the concentration of the molecule of interest in the sample based upon the association. practical application. See Revised Guidance — Section III(A)(2), 84 Fed. Reg. 54–55. Appeal 2020-004751 Application 14/173,461 11 We agree with the Examiner that these steps encompass abstract ideas in the category of mental processes. With regard to the “associating” step, the Specification states, with reference to Figure 8, that quantitation of samples within the concentration range of interest, which extends from the minimum concentration 182 to the maximum concentration 184, is possible by summing the signals obtained from the test sites 124 associated with the response curves 186 and 192. The concentration associated with the combined signal is obtained using the response curve 180, which is a summation of the response curves 186 and 192. Spec. ¶ 46. In other words, the signals from the two test sites are added together, and the combined signal is plotted on the combined response curve, which determines the concentration of the molecule of interest. These steps can be done in the human mind or with pen and paper, and therefore amount to an abstract idea in the category of mental processes. However, we do not agree with the Examiner that claim 1 recites a mathematical concept. Ans. 4–5. While “summing the first and second quantitation signals” undoubtedly involves mathematics, “[a] claim does not recite a mathematical concept (i.e., the claim limitations do not fall within the mathematical concept grouping), if it is only based on or involves a mathematical concept.” October 2019 Update at 3. Neither claim 1 nor claim 12 expressly recites “mathematical relationships, mathematical formulas or equations, [or] mathematical calculations.” Revised Guidance, 84 Fed. Reg. at 52. In summary, the last two steps of claim 1 can practically be performed in the human mind, and therefore recite an abstract idea in the category of mental processes. Appeal 2020-004751 Application 14/173,461 12 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. One of the exemplary considerations indicating that an additional element may integrate an exception into a practical application is “[a]n additional element [that] reflects an improvement in the functioning of a computer, or an improvement to other technology or technical field.” Id. at 55. Here, claim 1 as a whole integrates the recited abstract idea (mental processes) into a practical application. In addition to the final two steps that can practically be performed in the human mind, claim 1 recites steps of (a) establishing first and second test sites on an array, where both sites include the same probe molecule but are associated with different response curves, (b) summing the two response curves and storing the combined response curve, (c) exposing the test sites to the molecule of interest to bind differing first and second numbers of molecules at the two test sites, (d) obtaining quantitation signals associated with the first and second numbers of molecules, and (e) summing the signals, before carrying out the mental step Appeal 2020-004751 Application 14/173,461 13 of (f) associating the summed signal with the combined response curve to determine the concentration of the molecule of interest in the sample. Appellant’s Specification states that “[t]he dynamic range of a typical assay is generally between 1 to 3 orders of magnitude,” and “[t]he dynamic range of a particular assay limits the usefulness of the assay in applications wherein the expected variation in tested samples is several orders of magnitude.” Spec. ¶¶ 9–10. More specifically, “the expression range for many biomolecules can span 6 orders of magnitude or more and a convenient assay should have an equal dynamic range while the dynamic range of a typical assay is generally between 1 to 3 orders of magnitude.” Id. ¶ 10. The Specification describes efforts that have been made to increase the dynamic range of assays but states that each of these approaches has disadvantages. Id. ¶¶ 12–14. The Specification states that the combined response curve produced according to the claimed method, as shown in Figure 8, “extends substantially linearly throughout a concentration range of interest that is bounded by a minimum concentration 182 and a maximum concentration 184. The concentration range of interest is larger than the dynamic range of any single test site 124 for a given test environment.” Id. ¶ 43. Thus, quantitation of samples within the concentration range of interest, which extends from the minimum concentration 182 to the maximum concentration 184, is possible by summing the signals obtained from the test sites 124 associated with the response curves 186 and 192. The concentration associated with the combined signal is obtained using the response curve 180, which is a summation of the response curves 186 and 192. Id. ¶ 46. “Therefore, by carefully controlling the environment at each of a plurality of test sites 124, a combined output signal may be obtained which Appeal 2020-004751 Application 14/173,461 14 has a relatively linear relationship to the concentration of a molecule of interest.” Id. ¶ 47. The Specification thus describes the claimed method as an improvement in the technical field of affinity-based assays; specifically, the claimed method allows accurately quantitating a wider concentration range of a given analyte using a single array than would be possible using an array having test sites that are all exposed to the same testing environment. We therefore agree with Appellant that the claimed method represents “an improved affinity based technological process for quantitating a concentration of a molecule of interest using a single sample and a single probe molecule.” Appeal Br. 22. Thus, the claimed method, as a whole, is not “directed to . . . [a] patent-ineligible concept.” Alice, 573 U.S. at 217. The same analysis applies to independent claim 12, and therefore also to dependent claims 2–6, 9, 10, and 13–17. The Examiner reasons that it appears that the improvement is in the abstract idea itself, not a practical application thereof. As such, while an improvement to existing process may be patent eligible, the improvement cannot be the judicial exception itself. Therefore, as indicated in the rejection, it is maintained that the additionally recited claim elements fail to amount to an improvement, such that would render the claims eligible by way of practical application of the judicial exception(s). Ans. 20. We do not agree that the physical steps of establishing test environments, identifying response curves, exposing test sites to a sample, binding molecules of interest at the test sites, and obtaining quantitation signals are part of any abstract idea. These steps cannot be done in the Appeal 2020-004751 Application 14/173,461 15 human mind, they are not mathematical processes, and they are not methods of organizing human activity. They therefore do not fall into any of the categories of abstract ideas that are set out in the Revised Guidance. We agree, instead, with Appellant that the recited steps represent an improvement to the technical process involved in affinity-based assays. The Examiner also reasons that the evidentiary reference [Dufva] supports the position as set forth in the rejection that the active method steps (the wet assay steps, i.e., the limitations recited in addition to the abstract ideas) were steps that amount to well-known, routine and conventional steps performed by those of skill in the art at the time. Ans. 16. However, the analysis under Step 2A, prong 2, “specifically excludes consideration of whether the additional elements represent well-understood, routine, conventional activity.” Revised Guidance, 84 Fed. Reg. at 55. And [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. When the exception is so integrated, then the claim is not directed to a judicial exception . . . and is eligible. This concludes the eligibility analysis. Id. at 54. In summary, we reverse the rejection of independent claims 1 and 12 under 35 U.S.C. § 101. Claims 2–6, 9, 10, and 13–17 depend from claim 1 or claim 12, and we therefore reverse the rejection of these claims as well, for the reasons discussed above. Appeal 2020-004751 Application 14/173,461 16 DECISION SUMMARY In summary: Claim(s) Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1–6, 9, 10, 12–17 101 Eligibility 1–6, 9, 10, 12–17 REVERSED Copy with citationCopy as parenthetical citation