Ex Parte Wodlinger et alDownload PDFPatent Trials and Appeals BoardMay 30, 201914127136 - (D) (P.T.A.B. May. 30, 2019) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE FIRST NAMED INVENTOR 14/127,136 04/30/2014 Harold Wadlinger 134888 7590 06/03/2019 TAROLLI, SUNDHEIM, COVELL & TUMMINO L.L.P. 1300EASTNINTH STREET, SUITE 1700 CLEVELAND, OH 44114 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 ATTORNEY DOCKET NO. CONFIRMATION NO. CIN-020336 US PCT 2718 EXAMINER MEHL, PATRICK M ART UNIT PAPER NUMBER 3793 NOTIFICATION DATE DELIVERY MODE 06/03/2019 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): rkline@tarolli.com docketing@tarolli.com rs.patents.five@medtronic.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte HAROLD WODLINGER, CHARULATHA RAMANATHAN, and PING JIA 1 Appeal2017-008105 Application 14/127,136 Technology Center 3700 Before DONALD E. ADAMS, ERIC B. GRIMES, and FRANCISCO C. PRATS, Administrative Patent Judges. GRIMES, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134 involving claims to a system for localizing an object in a patient's body, which have been rejected as obvious and as being directed to patent-ineligible subject matter. We have jurisdiction under 35 U.S.C. § 6(b). We reverse. 1 Appellants identify the Real Party in Interest as Cardioinsight Technologies, Inc. Appeal Br. 3. Appeal2017-008105 Application 14/127,136 STATEMENT OF THE CASE "Various procedures exist in which an object is inserted into a patient's body as part of a low invasive procedure in which a view of the object is obstructed from a direct line of sight." Spec. ,r 3. "In such operations, it is desirable to determine a position of the catheter or other object, which is referred to as localization." Id. The Specification discloses "systems and methods ... [that] can be employed to localize an object, such as a catheter or pacing lead, by applying a localization signal (e.g., a pulse) to a patient's tissue to produce an electric field." Id. ,r 14. "Electrical signals corresponding to the electrical field can be sensed via a plurality of sensors." Id. "The sensed electrical signals can be mapped to tissue (e.g., corresponding to patient anatomy or a generic heart model) or other geometry based on geometry data for the patient." Id. "A location where the localization signal was applied to the heart can be determined from the mapped electrical signals." Id. Claims 18, 20, and 22-31 are on appeal. Claim 18 is the only independent claim and reads as follows: 18. A system to localize an object in a patient's body, the system comprising: at least one electrode fixed to the object in the patient's body; a pulse generator configured to generate a localization signal comprising a subthreshold electrical signal and provide the localization signal to the at least one electrode, the subthreshold electrical signal having energy insufficient to stimulate electrical conduction in tissue of the patient's body; 2 Appeal2017-008105 Application 14/127,136 a sensor array configured to detect an electrical field produced in response to the localization signal and provide respective sensor signals; and a processor configured to: retrieve geometry data stored in memory, the geometry data representing a geometric relationship between patient anatomy and the sensor array; reconstruct electrical signals based on the respective sensor signals and the geometry data; and determine an absolute location where the localization signal was applied based on comparing amplitude and frequency characteristics of each of the reconstructed electrical signals with respect to the localization signal. The claims stand rejected as follows: Claims 18, 20, and 22-31 under 35 U.S.C. § 101 as being directed to patent-ineligible subject matter (Final Action2 3); Claims 18, 20, 22, and 24--31 under 35 U.S.C. § 103 as obvious based on Armoundas3 and Rudy4 (Final Action 8); and Claim 23 under 35 U.S.C. § 103 as obvious based on Armoundas, Rudy, and Yang5 (Final Action 14--15). I The Examiner has rejected claims 18, 20, and 22-31 under 35 U.S.C. § 101 as being directed to patent-ineligible subject matter. The Examiner concludes that claim 18 "sets forth or describes [an] abstract idea" because it 2 Office Action mailed May 20, 2016. 3 Armoundas et al., US 6,370,412 Bl, issued Apr. 9, 2002. 4 Rudy, US 6,772,004 B2, issued Aug. 3, 2004. 5 Yang et al., US 2009/0157136 Al, published June 18, 2009. 3 Appeal2017-008105 Application 14/127,136 recites "'reconstruct[ing] electrical signals based on the respective sensor signals and the geometry data' and 'determin[ing] an absolute location where the localization signal was applied' and 'comparing amplitude and frequency characteristics of each of the reconstructed electrical signals with respect to the localization signal'." Final Action 3--4. The Examiner reasons that these "limitations are similar to mathematical concepts or operations for manipulating and/or relating data, organizing information through correlations; calculating parameters; and/or collecting and comparing known data, i.e. 'an idea of itself."' Id. at 4. The Examiner finds that "[t]he generically recited 'electrode', 'pulse generator' 'sensor array' (elements) are all well-understood elements performing functions that are routine and conventional in the art," and therefore, "[ v ]iewing all the additional claim limitations individually, or as an ordered combination, the claim(s) as a whole do (does) not add significantly more to the abstract idea." Id. at 5. Appellants argue that [ c] laim 18 sets out meaningful features that when considered as a whole (a combination) improve an existing approach of localizing an object in a patient's body as well as an effectiveness (accuracy) of a subsequent therapy or other medical procedure ( e.g., cardiac ablation, cardiac resynchronization therapy (CRT), etc.) that is based on localization of the object in the patient's body). Appeal Br. 7. Appellants also argue that "claim 18 requires a fundamental change to data and thus is a change that cannot be performed in the human mind." Id. at 8. Appellants argue that 4 Appeal2017-008105 Application 14/127,136 Id. the system of claim 18 includes a combination of interrelated structural features including at least one electrode, a pulse generator and a sensor array. It is by the claimed arrangement, configuration and interaction of such structure in conjunction with the operations of the processor that the system can localize an object in a patient's body. We agree with Appellant that the Examiner has not established that the claimed system is patent-ineligible. 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 Supreme Court has concluded that "[l]aws of nature, natural phenomena, and abstract ideas" are not patentable under 35 U.S.C. § 101. See, e.g., Alice Corp. v. CLS Bankint'l, 573 U.S. 208,216 (2014). To determine if a claim falls into an excluded category, we apply a two-step 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)). We first determine what 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. Kappas, 561 U.S. 593, 611 (2010) ("Claims 1 and 4 in petitioners' application explain the basic concept of hedging."). Patent-ineligible abstract ideas 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 (Gottschalkv. Benson, 409 U.S. 63, 69 (1972)). In contrast, patent-eligible inventions include 5 Appeal2017-008105 Application 14/127,136 physical and chemical processes, such as "molding rubber products" (Diamondv. Diehr, 450 U.S. 175, 192 (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 claimed method employed a mathematical formula, but the Supreme 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 176; see also id. at 192 ("We view respondents' claims as nothing more than a process for molding rubber products and not as an attempt to patent a mathematical formula."). The Supreme Court noted, however, 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. (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 tum to the second step of the Alice and Mayo framework, and "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 6 Appeal2017-008105 Application 14/127,136 more than a drafting effort designed to monopolize the [abstract idea].'" Id. ( quoting Mayo, 566 U.S. at 77 (alterations in original)). "[M]erely requir[ ing] generic computer implementation[] fail[ s] to transform that abstract idea into a patent-eligible invention." Id. We agree with Appellants that the Examiner erred in concluding that the claims are directed to an abstract idea without significantly more. The PTO recently published revised guidance on the application of§ 101. 2019 Revised Patent Subject Matter Eligibility Guidance, issued January 7, 2019 ("Memorandum"). Under that guidance, we first determine 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); and (2) additional elements that integrate the judicial exception into a practical application (see MPEP § 2106.0S(a}-(c), (e}-(h)). Only if a claim (1) recites a judicial exception and (2) does not integrate that exception into a practical application, do we then determine whether the claim: (3) adds a specific limitation beyond the judicial exception that is not a "well-understood, routine, conventional activity" in the field (see MPEP § 2106.0S(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. See Memorandum. 7 Appeal2017-008105 Application 14/127,136 Guidance Step 2(a), Prong 1 Claim 18 recites "at least one electrode," "a pulse generator," "a sensor array," and a processor configured to: retrieve geometry data stored in memory, the geometry data representing a geometric relationship between patient anatomy and the sensor array; reconstruct electrical signals based on the respective sensor signals and the geometry data; and determine an absolute location where the localization signal was applied based on comparing amplitude and frequency characteristics of each of the reconstructed electrical signals with respect to the localization signal. Claim 18. Claim 18 is not directed to a method of organizing human activity, nor has the Examiner established that the functions carried out by the processor of claim 18 could practicably be performed in the human mind, and therefore amount to a mental process. The final category of abstract ideas that has been identified by the courts is mathematical concepts. See Memorandum. Claim 18, however, does not recite any mathematical concept, such as a specific mathematical algorithm or formula (see Flook, 437 U.S. at 586; Diehr, 450 U.S. at 187). Claim 18 instead recites "retriev[ing] geometry data stored in memory," "reconstruct[ing] electrical signals based on the respective sensor signals and the geometry data," and "determin[ing] an absolute location where the localization signal was applied based on comparing amplitude and frequency characteristics of each of the 8 Appeal2017-008105 Application 14/127,136 reconstructed electrical signals with respect to the localization signal." Claim 18. While these steps involve mathematics, claim 18 does not recite a specific mathematical concept such as an algorithm or formula. Claim 18, therefore, does not recite an abstract idea that would make it patent- ineligible under 35 U.S.C. § 101. Guidance Step 2(a), Prong 2 In addition, even if claim 18 were interpreted to recite a mathematical concept, and therefore 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;" i.e., whether the claim "appl[ies], rel[ies] on, or use[ s] the judicial exception in a manner that imposes a meaningful limit on the judicial exception." 84 Fed. Reg. at 54. This analysis 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. Here, claim 18 as a whole integrates any recited mathematical concept into a practical application. Specifically, Appellants' Specification discloses that the claimed system is useful to "localize an object, such as a catheter or pacing lead, by applying a localization signal (e.g., a pulse) to a patient's tissue to produce an electric field." Spec. ,r 14. We therefore conclude that, even if the functions carried out by the processor of claim 18 were interpreted to be a mathematical concept, claim 18 as a whole integrates that concept into a practical application; specifically, localizing an object such as 9 Appeal2017-008105 Application 14/127,136 a catheter in a patient's body. Therefore, the claimed system, as a whole, is not "directed to ... [a] patent-ineligible concept." Alice, 573 U.S. at 217. We reverse the rejection of claim 18 under 35 U.S.C. § 101. Claims 20 and 22-31 depend from claim 18 and are therefore also patent-eligible for the reasons discussed above. II The Examiner has rejected claims 18, 20, 22, and 24--31 as obvious based on Armoundas and Rudy. The Examiner has also rejected claim 23 as obvious based on Armoundas, Rudy, and Yang. The same issue is dispositive for both rejections. The Examiner finds that Armoundas discloses most of the limitations of claim 18 (Final Action 9-10), but "does not teach the processor configured to determine an absolute location of the object" (id. at 10). The Examiner finds that Rudy teaches the determination of the absolute locations of a passive electrode array placed on a patient ( col.5 1st and 2nd ,r, Figs. 5(a) and 5(b )), using a geometry determining device (Col.4 last ,r) with storing these locations (Fig.5(a) #24 and col.5 2nCopy with citationCopy as parenthetical citation