David King et al.Download PDFPatent Trials and Appeals BoardOct 28, 20202020002685 (P.T.A.B. Oct. 28, 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. 13/138,622 02/02/2012 David H. King 4839-0001US (KP45995US-M) 7497 78855 7590 10/28/2020 Patent Capital Group Attn: Rosemary Bell 30 Flower Lane Levittown, PA 19055 EXAMINER COOK, CHRISTOPHER L ART UNIT PAPER NUMBER 3793 NOTIFICATION DATE DELIVERY MODE 10/28/2020 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): PAIR_78855@patcapgroup.com eofficeaction@appcoll.com roe@patcapgroup.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte DAVID H. KING and MOHAMMED AL-QAISI Appeal 2020-002685 Application 13/138,622 Technology Center 3700 ____________ Before MICHAEL C. ASTORINO, JAMES A. WORTH, and KENNETH G. SCHOPFER, Administrative Patent Judges. SCHOPFER, Administrative Patent Judge. DECISION ON APPEAL Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the Examiner’s decision to reject claims 1, 4, 5, 9–13, 15, 16, 19, 20, 24, 28–32, 34, 36–38, and 41–49. We have jurisdiction under 35 U.S.C. § 6(b). We REVERSE. 1 We use the word “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42. Appellant identifies the real party in interest as Bluedop Medical Ltd. Appeal Br. 1. Appeal 2020-002685 Application 13/138,622 2 BACKGROUND The Specification discloses “a system and method for estimating haemodynamic data, in particular although not exclusively to non-invasively obtaining in vivo mean pressure, mean pressure drop and/or hydraulic resistance data from within the normal and diseased segments of, in particular, the intact mammalian vascular system, human or animal.” Spec. ¶ 1. CLAIMS Claims 1, 34, 46, and 49 are the independent claims on appeal. Claim 1 is illustrative of the appealed claims and recites: 1. A system, including: a non-invasive blood flow measurement device; a display device; and a processing device, in communication with the non- invasive blood flow measurement device and with the display device, configured to: receive blood flow data, generated by the blood flow measurement device, wherein the blood flow data includes a velocity waveform of blood flow at a location in a segment of a vascular system of a mammal, or the blood flow data includes a flow rate waveform of blood flow at the location in the segment of the vascular system of the mammal; receive a central mean pressure of the mammal; determine a first measure of a shape of the blood flow data and store the first measure in a storage device in association with the corresponding location, wherein the first measure represents a ratio between (1) a difference between a maximum magnitude of the blood flow data and a minimum magnitude of the blood flow data and (2) an average magnitude of the blood flow data; Appeal 2020-002685 Application 13/138,622 3 generate a local pressure estimate by division of the central mean pressure by a sum of (1) unity and (2) a ratio of a second measure to the first measure, wherein the second measure represents a ratio between (1) a difference between a maximum magnitude of a central pressure waveform and a minimum magnitude of the central pressure waveform and (2) the central mean pressure; and cause the display device to display a visual representation of the local pressure estimate. Appeal Br., Claims App. 1. REJECTION The Examiner rejects claims 1, 4, 5, 9–13, 15, 16, 19, 20, 24, 28–32, 34, 36–38, and 41–49 under 35 U.S.C. § 101 as directed to an abstract idea without significantly more. DISCUSSION PRINCIPLES OF LAW 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. Appeal 2020-002685 Application 13/138,622 4 at 219 (“On their face, the claims before us are drawn to the concept of intermediated settlement, i.e., the use of a third party to mitigate settlement risk.”); see also Bilski v. Kappos, 561 U.S. 593, 611 (2010) (“Claims 1 and 4 in petitioners’ application explain the basic concept of hedging, or protecting against risk.”). Concepts determined to be abstract ideas, and thus patent ineligible, include certain methods of organizing human activity, such as fundamental economic practices (Alice, 573 U.S. at 219–20; Bilski, 561 U.S. at 611); mathematical formulas (Parker v. Flook, 437 U.S. 584, 594–95 (1978)); and mental processes (Gottschalk v. Benson, 409 U.S. 63, 67 (1972)). Concepts determined to be patent eligible include physical and chemical processes, such as “molding rubber products” (Diamond v. Diehr, 450 U.S. 175, 191 (1981)); “tanning, dyeing, making waterproof cloth, vulcanizing India rubber, smelting ores” (id. at 182 n.7 (quoting Corning v. Burden, 56 U.S. 252, 267–68 (1853))); 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) Appeal 2020-002685 Application 13/138,622 5 (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 (quotation marks omitted). “A claim that recites an abstract idea must include ‘additional features’ to ensure ‘that the [claim] is more than a drafting effort designed to monopolize the [abstract idea].’” Id. (alterations in original) (quoting Mayo, 566 U.S. at 77). “[M]erely requir[ing] generic computer implementation[] fail[s] to transform that abstract idea into a patent-eligible invention.” Id. USPTO Section 101 Guidance In January 2019, the U.S. Patent and Trademark Office (USPTO) published revised guidance on the application of § 101. 2019 Revised Patent Subject Matter Eligibility Guidance, 84 Fed. Reg. 50 (Jan. 7, 2019) (“2019 Revised Guidance”).2 “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. 2 In response to received public comments, the Office issued further guidance on October 17, 2019, clarifying the 2019 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 2020-002685 Application 13/138,622 6 Under the 2019 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”).3 2019 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. 2019 Revised Guidance, 84 Fed. Reg. at 52–56. 3 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 2019 Revised Guidance - Section III(A)(2), 84 Fed. Reg. at 54–55. Appeal 2020-002685 Application 13/138,622 7 ANALYSIS Step 2A, Prong One Per the 2019 Revised Guidance, we begin our Alice-step-one analysis by determining whether independent claim 1 “recites” an abstract idea under Prong One of Step 2A. (2019 Revised Guidance, 84 Fed. Reg. at 54.) The Guidance “extracts and synthesizes key concepts identified by the courts as abstract ideas,” and these concepts include “[m]athematical concepts,” and, more particularly, “mathematical relationships, mathematical formulas or equations, [and] mathematical calculations.” (Id. at 52.) With respect to each of the independent claims, the Examiner finds: The claim(s) recite(s) a mathematical relationship/formula /equations of determining a first measure of a shape of blood flow data (e.g. ratio between 1) a difference between maximum magnitude of the blood flow data and a minimum magnitude of the blood flow data and 2) an average magnitude of the blood flow data) and generating a local pressure estimate by division of a central mean pressure by a sum of 1) unity and 2) a radio of a second measure to the first measure, wherein the second measure represents a ratio between 1) a difference between maximum magnitude of a central pressure waveform and a minimum magnitude of the central pressure wave form and 2) the central mean pressure. Non-Final Act. 4. The Examiner determines that these limitations “fall within the ‘mathematical relationships, formulas or equations’ grouping of abstract ideas performed by generic computer components as set forth in the” Revised Guidance. Id. We agree with the Examiner at least to the extent claim 1 requires that the device determines a mathematical relationship in the form of “a ratio between (1) a difference between a maximum magnitude of the blood flow data and a minimum magnitude of the blood flow data and (2) an average magnitude of the blood flow data.” Appeal 2020-002685 Application 13/138,622 8 Such a mathematical relationship is one of the categories of abstract ideas set forth in the Revised Guidance, as discussed above. Thus, claim 1, for example, recites an abstract idea. Step 2A, Prong Two We next must determine “whether the claim as a whole integrates the recited judicial exception into a practical application of the exception.” Revised Guidance, 84 Fed. Reg. at 54. With respect to claim 1, the Examiner finds that, beyond the abstract ideas recited in the claim, “[t]he claim does not recite any additional elements that integrate the judicial exception into a practical application,” and that “[t]he only additional elements . . . are the non-invasive blood flow measurement device and the display device which merely add insignificant extra-solution activity to the judicial exception.” Non-Final Act. 4. The Examiner finds that these additional elements are akin to “merely recit[ing] limitations that amount to applying the judicial exception to a computer, merely using a computer as a tool to perform the abstract idea and elements which add insignificant extra-solution activity to the judicial exception.” Ans. 5. Under the Revised Guidance, we must evaluate the claim as a whole in order to determine if “the judicial exception is meaningfully limited by integration into a practical application of the exception.” Revised Guidance 84 Fed. Reg. at 55. As discussed below, we agree with Appellant that when the claim is considered as a whole and in light of the written description, the claims focus on an improvement to technology and/or a technical field. Thus, we agree with Appellant that the claim integrates the exception into a practical Appeal 2020-002685 Application 13/138,622 9 application such that the claims is not “directed to” the abstract idea discussed above. With respect to claim 1, we agree with the Examiner that additional elements in the claim include a blood flow measurement device and a display. The claim also recites a “processing device” in which measurements are received from the measurement device, and a local pressure estimate is ultimately generated for display on the display device. The Specification discloses that the invention relates to a non-invasive procedure for obtaining in vivo pressure in a mammalian vascular system. Spec. ¶ 1. The Specification describes that haemodynamic information is obtained in order to “gauge the clinical significance of individual lesions” in the vasculature of a patient. Id. ¶¶ 3, 4. “The ability to establish the magnitude of stenoses by measuring peak velocity within the stenosis has proved to be valuable clinically.” Id. ¶ 6. Such a measurement is not applicable in certain situations, and in these situations, the ability to measure “downstream blood pressure and pressure drop across a lesion have been shown to be sensitive indicators of stenotic disease.” Id. ¶¶ 6, 7. Thus, [i]t would be desirable to derive a direct measure of disease magnitude, one which is resistance based, computed from local blood flow and pressure data. The hydraulic resistance of a lesion is relatively independent of the state of the vascular load, be it vasoconstricted or vasodilated, and is able give a precise estimate of disease magnitude. Prior to the present invention, the non[-]invasive computation of ‘in vivo’ absolute mean arterial pressure and/or absolute hydraulic resistance of a lesion or a series of lesions, has not been practical except in the case of single isolated lesions under ideal conditions. Id. ¶ 8. The Specification discloses embodiments that: provide a system and method for deriving information or data on a lesion based on a form factor of wave forms derived non- Appeal 2020-002685 Application 13/138,622 10 invasively using measured physiological data such as blood velocity or flow rates and pressure supplying a specific vascular bed, that is the vascular vessels and tissues of an organ or muscle[], under examination. Id. ¶ 10. The Specification discloses that the measurements obtained by the system can be used “to derive haemodynamic data indicative of the presence or absence of a lesion, and/or indicative of a response of a healthy vascular system to stimuli such as drug infusion.” Id. ¶ 12. Further, the Specification discloses: By measuring or estimating incident blood pressure and local blood flow rate noninvasively at selected points in the vascular bed, the magnitude of the increased haemodynamic resistances due to a lesion can be calculated and mapped and changes in resistances and other measures can be used to pinpoint the location of a stenosis. Id. ¶ 11. Based on the foregoing evidence, we agree with Appellant that the Specification makes clear that “the present application represent[s] an improvement in physiological monitoring technology” by providing “a non- invasive physiological monitor that may be used by a clinician to identify a lesion or series of lesions in a patient well before such lesions may be detect[ed] using conventional, invasive approaches.” Appeal Br. 9–10. We also agree that, for example, claim 1 reflects the improvement disclosed in the written description by providing a device that generates and displays local pressure estimates that may be used to pinpoint the location of a lesion. Id. at 10. When considering the additional elements in combination with the mathematical relationships recited, we determine that the additional elements reflect an improvement to the technical fields of physiological monitoring technology, and more specifically, to the diagnosis of stenosis in Appeal 2020-002685 Application 13/138,622 11 a patient. Thus, we determine that the claim as a whole integrates the judicial exception, i.e., the abstract idea, into a practical application that ensures “the claim is more than a drafting effort designed to monopolize the judicial exception.” Revised Guidance, 84 Fed. Reg. at 55. Accordingly, we determine that claim 1 is not directed to the identified abstract idea under Step 2A of the Revised Guidance. We reach the same conclusion with respect to each of the other independent claims, which provide similar limitations for generating and displaying a local pressure estimate in the vasculature of a patient. As such, there is no need to perform Step 2B of the 2019 § 101 Guidance (and/or Alice step two), and “this concludes the eligibility analysis.” (2019 § 101 Guidance, Federal Register Vol. 84, No. 4, at 54.) Based on the foregoing, we do not sustain the rejection of the claims on appeal. CONCLUSION We REVERSE the rejection of the claims under 35 U.S.C. § 101. In summary: Claims Rejected 35 U.S.C. § Basis Affirmed Reversed 1, 4, 5, 9–13, 15, 16, 19, 20, 24, 28– 32, 34, 36– 38, 41–49 101 Eligibility 1, 4, 5, 9– 13, 15, 16, 19, 20, 24, 28–32, 34, 36–38, 41– 49 REVERSED Copy with citationCopy as parenthetical citation