Ex Parte Harks et al

Patent Trial and Appeal BoardMar 20, 2017

13576022 (P.T.A.B. Mar. 20, 2017)

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. 13/576,022 07/30/2012 Godefridus Antonius Harks 2010P00116WOUS 2757 24737 7590 03/22/2017 PTTTT TPS TNTFT T FfTTTAT PROPFRTY fr STANDARDS EXAMINER 465 Columbus Avenue PONTIUS, KEVIN LANE Suite 340 Valhalla, NY 10595 ART UNIT PAPER NUMBER 3768 NOTIFICATION DATE DELIVERY MODE 03/22/2017 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): marianne. fox @ philips, com debbie.henn @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 GODEFRIDUS ANTONIUS HARKS, SZABOLCS DELADI, JAN FREDERIK SUIJVER, MAYA ELLA BARLEY, and EDWIN GERARDUS JOHANNUS MARIA BONGERS Appeal 2015-005984 Application 13/576,0221 Technology Center 3700 Before JOHN C. KERINS, STEFAN STAICOVICI, and LEE L. STEPINA, Administrative Patent Judges. STAICOVICI, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Godefridus Antonius Harks et al. (Appellants) appeal under 35 U.S.C. § 134(a) from the Examiner’s final decision rejecting claims 1—7 and 9—15.2 We have jurisdiction over this appeal under 35 U.S.C. § 6(b). 1 According to Appellants, Koninklijke Philips NV is the real party in interest. Appeal Br. 2 (filed Nov. 12, 2014). 2 Claim 8 is canceled. Id. Appeal 2015-005984 Application 13/576,022 SUMMARY OF DECISION We AFFIRM, and denominate our affirmance as a NEW GROUND OF REJECTION pursuant to our authority under 37 C.F.R. § 41.50(b). INVENTION Appellants’ invention relates “to a system and method for combined ablation and ultrasound imaging.” Spec. 1,11. 3^4. Claims 1, 12, and 15 are independent. Claim 1 is illustrative of the claimed invention and reads as follows: 1. A system (100) for combined ablation and ultrasound imaging of associated tissue (40, 540), the system comprising an interventional device (20), the interventional device comprising, an ultrasound transducer (5, 505), and an ablation unit (15, 516), and a controlling unit (CTRL) being operably connected to the interventional device (20), the controlling unit (CTRL) being arranged to send a control signal (CoS) to the ultrasound transducer (5, 505), receive a response signal (ReS) from the ultrasound transducer, the response signal (ReS) being indicative of the presence of one or more bubbles within said associated tissue ( 40, 540), and calculate a predictor value (PV), where the predictor value (PV) relates to a risk of an impending tissue damage due to a rapid release of a bubble energy, wherein the ultrasound transducer (5,505) is arranged for emitting ultrasonic signals (A2) having a frequency sufficiently high in order to detect one or more bubbles in the associated tissue (40, 540), and wherein the frequency is above 10 MHz. 2 Appeal 2015-005984 Application 13/576,022 REJECTIONS The following rejections are before us for review:3 I. The Examiner rejected claims 1—6, 9, and 11—15 under 35 U.S.C. § 103(a) as being unpatentable over Jackson (US 2005/0283074 Al, published Dec. 22, 2005). II. The Examiner rejected claim 7 under 35 U.S.C. § 103(a) as being unpatentable over Jackson, Ingle (US 2009/0287205 Al, published Nov. 19, 2009), and Thapliyal (US 8,414,508 B2, issued Apr. 9, 2013). III. The Examiner rejected claim 10 under 35 U.S.C. § 103(a) as being unpatentable over Jackson and Savery (US 2010/0168571 Al, published July 1, 2010). IV. The Examiner rejected claim 15 under 35 U.S.C. § 101 as being directed to non-statutory subject matter.4 ANALYSIS Rejection I Appellants have not presented arguments for the patentability of claims 2—6, 9, and 11—15 apart from claim 1. See Appeal Br. 8—11. Therefore, in accordance with 37 C.F.R. § 41.37(c)(l)(iv), we select claim 1 as the representative claim to decide the appeal of the rejection of these claims, with claims 2—6, 9, and 11—15 standing or falling with claim 1. 3 The rejection of claims 1—6, 9, and 11—15 under 35 U.S.C. § 102(b) as being anticipated by Ingle is withdrawn. See Ans. 8 (transmitted Mar. 27, 2015); see also Final Act. 4—7 (transmitted June 19, 2014). 4 The Examiner added the rejection of claim 15 under 35 U.S.C. § 101 as a new ground of rejection. See id. at 7—8. 3 Appeal 2015-005984 Application 13/576,022 The Examiner finds that the system of Jackson includes an interventional device that includes an ultrasound transducer 12 and a controller unit 20. Final Act. 8 (citing Jackson || 17, 27, Fig. 2). The Examiner finds that, “[t]he control[er] unit of Jackson ... is arranged to . . . receive a response signal from the ultrasound transducer, the response signal being indicative of the presence of one or more bubbles within said associated tissue.” Id. (citing Jackson 127). Appellants argue that the disclosure of “Jackson is clearly directed to detecting bubbles at the interface between electrode and tissue as described in the present specification at page 3 lines 4—8, which does not necessarily relate to gas formation in tissue.” Appeal Br. 9. Appellants assert that Jackson detects bubble formation at the electrode-tissue interface because Jackson discloses that “the tissue undergoing treatment cannot be directly visualized.” Id. (citing Jackson 14). The Examiner responds that “any gas bubbles formed at the electrode tissue interface are necessarily formed in the tissue.” Ans. 9—10. According to the Examiner, because adjacent fluids are required to image tissue using ultrasound energy and “ultrasonic energy travels back-and-forth across a tissue-fluid interface ... the resulting image naturally shows what is present in both the fluid and the tissue.” Id. at 11. The Examiner notes that paragraph 32 of Jackson “is evidence for the interpretation of Jackson’s disclosure that both tissue and fluid are imaged via ultrasound imaging, and that formed bubbles are imaged as distinct with respect to both the tissue and the fluid.” Id. at 12. 4 Appeal 2015-005984 Application 13/576,022 In reply, Appellants assert that “bubble detection in tissue is not inherent in imaging a fluid region” because “ultrasound imaging . . . does not show regions outside of the focus of the imaging system,” i.e., the fluid region. Reply Br. 7. According to Appellants, “Jackson is teaching away from the present invention, [by] believing that microbubbles in tissue cannot be visualized using ultrasound imaging, and that instead microbubble formation should be visualized in fluid.” Id. Although we appreciate that Jackson discloses imaging bubbles at a fluid-tissue interface, nonetheless, we note that Jackson also discloses imaging bubbles in the tissue because Jackson specifically discloses that during the imaging process “[t]he fluid and tissue regions are repetitively scanned during the tissue ablation procedure.” Jackson 131 (emphasis added). More specifically, Jackson discloses that when positioning an ultrasonic transducer adjacent to tissue to be treated, “the imaging plane or other region is positioned to include both the tissue as well as fluid adjacent to the tissue.” Id. (emphasis added). Jackson further discloses that after a region of interest associated with the fluid or the tissue is identified, separate image processing is provided for the fluid and the tissue regions in order to identify the newly detected bubbles. Id. 134. For example, for B-mode imaging, the tissue appears as bright to mid-range reflectors and fluid appears as dark to mid-range reflectors. Id. 131. Hence, as bubbles are detected, the pixels associated with the bubbles are highlighted as an overlay or modulation on the B-mode image that includes both fluid and tissue regions. Id. 134. Furthermore, Jackson also measures bubble characteristics within the region of interest, disclosing that “[a]n increase in 5 Appeal 2015-005984 Application 13/576,022 signal intensity within the fluid region, a predefined region, a user defined region of interest, the tissue region or elsewhere indicates the existence or magnitude of type 1 or type 2 bubbles.” Id. 137 (emphasis added). Hence, as Jackson measures bubble characteristics in the tissue region using imaging signals emitted by a transducer (see Jackson 131, Fig. 1; see also Final Act. 8), we agree with the Examiner that Jackson discloses an ultrasound transducer signal that indicates the presence of (detects) bubbles within the tissue, as required by claim 1. See Ans. 12. Appellants also argue that paragraph 4 of Jackson teaches away from the invention because Jackson “believ[es] that microbubbles in tissue cannot be visualized using ultrasound imaging, and that instead microbubble formation should be visualized in fluid.” Reply Br. 7. We do not agree with Appellants’ assessment because Jackson’s paragraph 4 does not refer to ultrasound visualization of the bubbles formed in the fluid or the tissue to be ablated, as Appellants contend, but rather to direct visualization of the tissue being ablated. According to paragraph 4 of Jackson, the tissue to be ablated cannot be directly visualized, so Jackson provides examples of other, indirect methods indicative of tissue damage such as measuring the electrical impedance between an ablation catheter and a grounding patch located on the patient’s back or monitoring bubble formation during an ablation procedure using ultrasound imaging. See Jackson paras. 4, 5. Jackson further discloses that bubble formation occurs in the tissue region and adjacent the tissue region and uses a change in signal intensity to detect a change in bubble characteristics in a region of interest, which can be a tissue region, to adjust ablation energy and hence, prevent 6 Appeal 2015-005984 Application 13/576,022 tissue damage. See Jackson || 35—41. Therefore, Jackson’s use of ultrasound imaging does not teach away from the claimed invention. Appellants further argue that Jackson does not calculate a predictor value because “Jackson observes a brisk shower of dense microbubbles and terminates ablation.” Appeal Br. 13. Appellants assert that an increase in the number of bubbles “cannot be [the] predictor value of the present invention, because it is not a calculated value.” Reply Br. 9. We do not find this argument persuasive because Jackson specifically discloses that “an intensity characteristic is calculated” as “an increase in signal activity within the . . . the tissue region . . . [that] indicates the existence or magnitude of type 1 or type 2 bubbles.” Jackson 137 (emphasis added). Jackson further discloses that the calculated intensity characteristic is compared to a threshold value and a signal is generated as an auditory or visual warning to reduce the ablation energy provided to the tissue. Id. 38, 40. Accordingly, in contrast to Appellants’ position, Jackson’s intensity characteristic constitutes a calculated value. Moreover, as Jackson’s signal is generated as an auditory or visual warning to reduce the ablation energy, we do not agree with Appellants’ position that Jackson’s intensity characteristic “is not related to the risk of impending tissue damage.” See Appeal Br. 13. Lastly, Appellants argue that neither Jackson nor any other of the references of record discloses that “the transducer emits ultrasound where ‘the frequency is above 10 MHz,”’ as recited in claim 1. Appeal Br. 13—14. Appellants assert that “Jackson does not make any statement on frequency range and it is believed that the Examiner is referring to Ingle at paragraph 7 Appeal 2015-005984 Application 13/576,022 [0049]” to find a transducer that employs a frequency above 10 MHz. Appeal Br. 14 (citing Adv. Act. (transmitted Aug. 29, 2014)). However, Appellants note that Ingle merely provides examples of frequencies of 20 kHz and 10 MHz, but does not disclose frequencies above 10 MHz. Id. Appellants thus assert that this feature is not “obvious since none of the references suggest using a frequency above 10MHz.” Id. at 14. Appellants’ arguments are not persuasive, because they are not commensurate with the Examiner’s rejection. The Examiner concedes that Jackson fails to disclose a frequency that is above 10 MHz, but nonetheless, concludes that it would have been obvious to a person of ordinary skill in the art “to calibrate the ultrasound transducer of Jackson to emit[] ultrasonic signals at a frequency above 10MHz as a matter of common sense engineering to use a frequency range that is intentionally distinct from (so as to avoid interference from) that of the ablation unit.'1'’ Final Act. 8—9 (emphasis added). Appellants do not adequately explain why a person of ordinary skill in the art would not have found it obvious to employ an ultrasound transducer frequency range that is intentionally distinct from that of Jackson’s ablation unit. In other words, Appellants do not sufficiently explain why the Examiner’s reasoning to modify Jackson’s transducer to emit ultrasonic signals at a frequency above 10MHz lacks rational underpinnings. Nor do Appellants adequately explain why the Examiner’s proposed calibration would be beyond the abilities of one of ordinary skill in the art of ultrasound imaging. As such, Appellants have not apprised us of error in the Examiner’s findings and reasoning. Moreover, we note that Ingle specifically discloses an ultrasound transducer employing a frequency 8 Appeal 2015-005984 Application 13/576,022 of “less than or equal to about 10 MHz,” which includes a frequency of 10 MHz. See Ingle 149 (emphasis added). In conclusion, for the foregoing reasons, we sustain the rejection under 35 U.S.C. § 103(a) of independent claim 1 as unpatentable over Jackson. Claims 2—6, 9, and 11—15 fall with claim 1. However, we denominate our affirmance as a NEW GROUND OF REJECTION pursuant to 37 C.F.R. § 41.50(b), because our analysis relies upon facts and reasoning that the Examiner did not use. Rejections II and III Appellants do not make any other substantive arguments regarding the rejection of claims 7 and 10. See Appeal Br. 5—15. Therefore, for the reasons discussed above, we likewise sustain the rejections under 35 U.S.C. § 103(a) of claim 7 as unpatentable over Jackson, Ingle, and Thapliyal and of claim 10 as unpatentable over Jackson and Savery. As claims 7 and 10 depend from claim 1, we denominate our affirmance as a NEW GROUND OF REJECTION pursuant to 37 C.F.R. § 41.50(b), because our analysis relies upon facts and reasoning that the Examiner did not use. Rejection IV The Examiner finds that, “claim 15 is directed to a mathematical formula (see lines 6—8 reciting ‘calculating a predictor value (PV) based on information ... ‘), which is an abstract idea.” Ans. 7. The Examiner states 9 Appeal 2015-005984 Application 13/576,022 that the additional elements do not “amount to significantly more than the judicial exception because the recited ‘receiving of information serves to simply provide input variable data for the mathematical formula, and because the result of the calculation appears to be simply a bare number.” Id. at 7—8. Appellants reply that: While calculating a predictor value may be an abstract idea, calculating a predictor value based on information derived from the secondary ultrasound signal, and calculating a predictor value where the predictor value relates to a risk of an impending tissue damage due to a rapid release of a bubble energy constitute a specific application of the calculation. Reply Br. 11. Appellants thus argue that when the claim is considered as a whole, it meets the requirements of 35 U.S.C. § 101. See id. The Supreme Court has set forth “a framework for distinguishing patents that claim laws of nature, natural phenomena, and abstract ideas from those that claim patent-eligible applications of those concepts.” Alice Corp. Pty. Ltd. v. CLS Bank Inti, 134 S. Ct. 2347, 2355 (2014) (citing Mayo Collaborative Servs. v. Prometheus Labs, Inc., 132 S. Ct. 1289, 1294 (2012). According to the Supreme Court’s framework, we must first determine whether the claims at issue are directed to one of those concepts (i.e., laws of nature, natural phenomena, and abstract ideas). Id. If so, we must secondly “consider the elements of each claim both individually and ‘as an ordered combination’ to determine whether the additional elements ‘transform the nature of the claim’ into a patent-eligible application.” Id. The Supreme Court characterizes the second step of the analysis as “a search for an ‘inventive concept’ — i.e., an element or combination of elements that is 10 Appeal 2015-005984 Application 13/576,022 ‘sufficient to ensure that the patent in practice amounts to significantly more than a patent upon the [ineligible concept] itself.”’ Id. In this case, we do not agree with the Examiner that claim 15 is directed to a mathematical formula. See Ans. 7. Rather claim 15 is directed to a computer readable storage medium adapted to enable a computer to operate a processor to perform the steps: (1) receiving information derived from an ultrasonic signal indicative of the presence of one or more bubbles within associated tissue, and (2) calculating a predictor value (PV) based on information derived from the secondary ultrasonic signal. See Appeal Br. 19 (Claims App.). We appreciate that the steps of receiving information and calculating a value, in themselves, have long been held patent-ineligible,. See Parker v. Flook, 98 S. Ct. 2522, 2528 (1978) (internal quotations omitted) (“if a claim is directed essentially to a method of calculating, using a mathematical formula, even if the solution is for a specific purpose, the claimed method is nonstatutory.”). However, in light of the framework set forth in Alice, the Examiner has not shown sufficiently that a computer and processor specifically programmed to receive information derived from an ultrasonic signal and to calculate a value based on the received information is a generic computer and processor. In conclusion, for the foregoing reasons, we do not sustain the rejection of claim 15 under 35 U.S.C. § 101 as being directed to patent ineligible subject matter. 11 Appeal 2015-005984 Application 13/576,022 DECISION The Examiner’s decision to reject claims 1—7 and 9—15 under 35 U.S.C. § 103(a) is affirmed. The Examiner’s decision to reject claim 15 under 35 U.S.C. § 101 is reversed. For the reasons discussed above, we denominate our affirmance of the rejections of claims 1—7 and 9-15 as new grounds of rejection pursuant to 37 C.F.R. § 41.50(b). This decision contains new grounds of rejection pursuant to 37 C.F.R. § 41.50(b). 37 C.F.R. § 41.50(b) provides “[a] new ground of rejection pursuant to this paragraph shall not be considered final for judicial review.” 37 C.F.R. § 41.50(b) also provides: When the Board enters such a non-final decision, the appellant, within two months from the date of the decision, must exercise one of the following two options with respect to the new ground of rejection to avoid termination of the appeal as to the rejected claims: (1) Reopen prosecution. Submit an appropriate amendment of the claims so rejected or new Evidence relating to the claims so rejected, or both, and have the matter reconsidered by the Examiner, in which event the prosecution will be remanded to the Examiner. The new ground of rejection is binding upon the examiner unless an amendment or new Evidence not previously of Record is made which, in the opinion of the examiner, overcomes the new ground of rejection designated in the decision. Should the examiner reject the claims, appellant may again appeal to the Board pursuant to this subpart. (2) Request rehearing. Request that the proceeding be reheard under § 41.52 by the Board upon the same Record. The 12 Appeal 2015-005984 Application 13/576,022 request for rehearing must address any new ground of rejection and state with particularity the points believed to have been misapprehended or overlooked in entering the new ground of rejection and also state all other grounds upon which rehearing is sought. Further guidance on responding to a new ground of rejection can be found in the Manual of Patent Examining Procedure § 1214.01. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a)(l)(iv). AFFIRMED; 37 C.F.R, $ 41.50(b) 13