Mischa Megens et al.Download PDFPatent Trials and Appeals BoardAug 12, 201913393857 - (D) (P.T.A.B. Aug. 12, 2019) 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. 13/393,857 03/02/2012 Mischa Megens 2009P01218WOUS 6173 24737 7590 08/12/2019 PHILIPS INTELLECTUAL PROPERTY & STANDARDS 465 Columbus Avenue Suite 340 Valhalla, NY 10595 EXAMINER TURCHEN, ROCHELLE DEANNA ART UNIT PAPER NUMBER 3793 NOTIFICATION DATE DELIVERY MODE 08/12/2019 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): 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 MISCHA MEGENS and JAN SUIJVER __________ Appeal 2018-002857 Application 13/393,857 Technology Center 3700 __________ Before DONALD E. ADAMS, JEFFREY N. FREDMAN, and TIMOTHY G. MAJORS, Administrative Patent Judges. FREDMAN, Administrative Patent Judge DECISION ON APPEAL This is an appeal1,2,3 under 35 U.S.C. § 134 involving claims to a medical ultrasound device with temperature detection at the distal end. The Examiner rejected the claims on the grounds of provisional obviousness-type double-patenting and obviousness. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. 1 Appellants identify the Real Party in Interest as Koninklijke Philips Electronics N.V. (see App. Br. 3). 2 This Appeal is the second appeal in this application. The previous appeal was Appeal No. 2014-007832. 3 We have considered and herein refer to the Specification of Mar. 2, 2012 (“Spec.”); Final Office Action of May 22, 2017 (“Final Act.”); Appeal Brief of Oct. 23, 2017 (“App. Br.”); Examiner’s Answer of Nov. 24, 2017 (“Ans.”); and Reply Brief of Jan. 23, 2018 (“Reply Br.”). Appeal 2018-002857 Application 13/393,857 2 Statement of the Case Background “In connection with the ablation process of cardiac tissue, it is commonly used to monitor the temperature of the probe during the ablation process. Since the probe is in close proximity with the tissue during the ablation process, the probe temperature reflects the tissue temperature” (Spec. 1:12–15). However, the “placement of thermocouple on the electrode surface however puts the thermocouple in the field of view. While this may be acceptable for some application, this may not be the case for all applications” (Spec. 1:24–26). Appellants’ invention “relates to a medical ultrasound device, such as a probe or catheter-based device. In particular the invention relates to such devices capable of detecting the temperature at the distal end of the device” (Spec. 1:2–4). The Claims Claims 1–10 and 14 are on appeal. Independent claim 1 is representative and reads as follows: 1. A medical ultrasound device comprising: an elongated body having a proximal end, a distal end, a distal end region and a length axis along the elongation; one or more ultrasound transducers for generating acoustic radiation, the one or more ultrasound transducers being positioned in the distal end region, inside the elongated body; a transmission element positioned in the radiation path of the acoustic radiation, wherein the transmission element is substantially transparent to acoustic radiation; and a controller unit operatively connected to the ultrasound transducer to detect the acoustic path length through the transmission element and to determine a temperature at the distal end from the detected acoustic path length. Appeal 2018-002857 Application 13/393,857 3 The Issues4 A. The Examiner provisionally rejected claims 1–10 and 14 under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1–15 of US 13/393,244 now US 9,681,923 B2, issued June 20, 2017 (hereafter “Barley”) (Final Act. 2–3). B. The Examiner rejected claims 1, 2, 4, 5, 10, and 14 under 35 U.S.C. § 103(a) as obvious over Lang5 and Mast6 (Final Act. 4–9). C. The Examiner rejected claims 3 and 7–9 under 35 U.S.C. § 103(a) as obvious over Lang, Mast, and Sliwa7 (Final Act. 9–10). D. The Examiner rejected claim 6 under 35 U.S.C. § 103(a) as obvious over Lang, Mast, and Barnes8 (Final Act. 10). A. Provisional obviousness-type double patenting over claims 1–15 of Barley The Examiner finds “both the present application and the co-pending application are directed to an ultrasound device comprising an elongated body, one or more transducers, a transmission element and a controller unit” (Ans. 13). The Examiner acknowledges that: While the co-pending application requires the “transmission element and the one or more ultrasound transducers are mounted so that an acoustic path length between the transmission element and each ultrasound transducer varies with contact force imposed to the distal end region,” there is no 4 The Examiner withdrew the rejection of claims 6, 7, and 10 under 35 U.S.C. § 112, second paragraph (see Ans. 11). 5 Lang et al., US 2003/0078498 A1, published Apr. 24, 2003. 6 Mast et al., US 2004/0127791 A1, published July 1, 2004. 7 Sliwa et al., US 2010/0168572 A1, published July 1, 2010. 8 Barnes et al., US 2004/0236223 A1, published Nov. 25, 2004. Appeal 2018-002857 Application 13/393,857 4 specific configuration which provides a distinction from the ultrasound transducer and the transmission element of the present application. (Ans. 13). The Examiner finds the “configuration of the ultrasound transducer and transmission element of the present application are structurally the same and would provide the same result of this limitation” (Ans. 13). Appellants contend “the transmission element acoustic path length principle encompassed by independent claims 1, 10 and 14 of Megens [instant claims] is patentably distinct from the contact force acoustic path length principle encompassed by independent claims 1, 12, 14 and 15 of Barley” (App. Br. 14). We find that Appellants have the better position under the current facts. When our previous decision was written, the claims of US 13/393,244 lacked the current “controller unit configured to” language that imposes specific programming elements correlating contact force and acoustic path length. See, e.g., Typhoon Touch Techs., Inc. v. Dell, Inc., 659 F.3d 1376, 1380 (Fed. Cir. 2011). The Examiner does not explain why it would have been obvious to modify a controller unit configured to determine contact force based on path length into a controller that determines temperature based on the detected acoustic path length. Because the related case uses the “configured to” language for the controller, the “programming creates a new machine, because a general purpose computer in effect becomes a special purpose computer once it is programmed to perform particular functions pursuant to instructions from program software.” Ultramercial, LLC v. Hulu, LLC, 657 F.3d 1323, 1328–29 (Fed. Cir. 2011). Therefore, without a reason or other Appeal 2018-002857 Application 13/393,857 5 evidence to modify the device recited in the claims of US 13/393,244 to measure temperature, the Examiner has not established a prima facie case of obviousness-type double patenting. B. 35 U.S.C. § 103(a) over Lang and Mast The Examiner finds Lang teaches a medical ultrasound device and control unit comprising: an elongated body having a proximal end, a distal end, a distal region and a length axis along the elongation (fig.1 ); one or more ultrasound transducers for generating acoustic radiation, the one or more ultrasound transducers being positioned in the distal end region, inside the elongate body ([0015];[0085]); a transmission element positioned in the radiation path of the acoustic radiation, wherein the transmission element is substantially transparent to acoustic radiation ([0085];[0101]); and a controller unit operatively connected to the ultrasound transducer ([0040]), and a data storage means ([0072]) (Final Act. 5). The Examiner acknowledges that Lang does not teach “detecting the acoustic path length through the transmission element and to determine a temperature at a distal end from the detected acoustic path length” (Final Act. 5). The Examiner finds Mast teaches “detecting the acoustic path length through the transmission element and to determine a temperature at a distal end from the detected acoustic path length (sound speed) ([0012])” (Final Act. 5). The Examiner finds it obvious “to modify the medical ultrasound device and control unit of Lang et al with determining an acoustic path and a temperature because Mast teaches that this arrangement is highly desirable, Appeal 2018-002857 Application 13/393,857 6 since heating effects of ultrasound treatment may be measured using inexpensive, portable, and unobtrusive ultrasound apparatus” (Final Act. 5– 6). The issue with respect to this rejection is: Does a preponderance of the evidence of record support the Examiner’s conclusion that Lang and Mast render claim 1 obvious? Findings of Fact 1. Lang teaches “a hand-held ultra-sonic system that includes a transducer for transmitting and receiving ultra-sonic waves for . . . tissue measurement, an electronic operating unit to control and process ultrasonic wave generation and detection, and a display” (Lang ¶ 95). 2. Lang’s Figure 1 is reproduced below: Figure 1 “shows an object plane relative to an ultrasonic probe 2 with an acoustic coupling gel 3 between the probe 2 and the object plane and having a connection 1 to signal processing unit” (Lang ¶ 18). 3. Lang teaches that the computational unit is capable of determining the shortest reflective distance when two or more ultra-sonic sources are Appeal 2018-002857 Application 13/393,857 7 employed at different transmission angles. The computational unit may also be used for controlling the ultra-sonic generator or source, for defining or varying the firing rate and pulse repetition rate (as well as other parameters related to the ultra- sonic generator or source), for measuring the reflected signal, for image reconstruction in B-scan mode and for filtering and thresholding of the ultra-sonic signal. (Lang ¶ 40). 4. Lang teaches an “adjustment sets the threshold of signal amplitudes that are permitted to enter a data storage, processing or display system” (Lang ¶ 72). 5. Mast teaches that [s]ince the travel time of an ultrasonic echo depends on both the path length (which is changed by any thermal expansion) and sound speed (which depends on temperature), temperature changes in tissue being treated cause measurable alterations to echo travel times. By estimation and further processing of these travel times, temperature rises can be approximately mapped. This arrangement is highly desirable, since heating effects of ultrasound treatment may be measured using inexpensive, portable, and unobtrusive ultrasound apparatus. For configurations in which therapy and monitoring are performed using the same ultrasound probe, this approach is particularly desirable, since a temperature map may be automatically co-registered with the therapeutic ultrasound beams. (Mast ¶ 12). 6. Mast teaches: It is well-known that the travel time of an ultrasound wave varies with the path length. The path length may vary in anatomic tissue due to thermal expansion of the tissue as a result of therapeutic ultrasound treatment, such as hyperthermia and ablation. Further, the travel time of an ultrasound wave varies with the speed of the ultrasound wave, which is a Appeal 2018-002857 Application 13/393,857 8 function of path temperature. Thus, changes in ultrasound wave travel times may be used to estimate temperature rise. (Mast ¶ 28). 7. Mast teaches that the “relative delay between ultrasound echos returning to an ultrasound transducer, measured before and after treatment, is estimated as a function of depth . . . . The slope of the depth-dependent delay represents echo strain . . . . The amount of echo strain is proportional to the temperature rise of the heated region” (Mast ¶ 29). 8. Figure 1A of Mast is reproduced below: “FIG. 1A generally illustrates a first ultrasound signal 11 returning to an ultrasound transducer (not shown) before treatment of a region of tissue, while ultrasound signal 13 represents an ultrasound signal returning to the ultrasound transducer after treatment of the tissue” (Mast ¶ 29). Principles of Law “The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). “If a person of ordinary skill can implement a predictable variation, § 103 likely bars its patentability.” Id. at 417. As noted by the Court in KSR, “[a] person of Appeal 2018-002857 Application 13/393,857 9 ordinary skill is also a person of ordinary creativity, not an automaton.” Id. at 421. Analysis We adopt the Examiner’s findings concerning the scope and content of the prior art (Final Act. 4–9; FF 1–8), and agree that the claims are obvious over Lang and Mast. We address Appellants’ arguments below. Appellants asserts that the claims “encompass a ‘transmission element acoustic path length principle’ directed to a radiation path segment extending through a transmission element whereby an acoustic path length of this radiation path segment serves as a basis for determining a temperature at a distal end of a medical ultrasound device” (App. Br. 17). Appellants contend that Lang differs because Lang teaches “an ‘object thickness acoustic path length principle’ directed to an object radiation path segment extending between an external surface of an object to be imaged by acoustic radiation and one or more internal reflective layers of the object” (App. Br. 17). Appellants contend that Mast differs because Mast describes ‘object temperature acoustic path length principle’ directed to an object radiation path segment extending between an external surface of an object to be imaged by acoustic radiation and one or more internal reflective layers of the object (e.g., anatomical tissue) whereby an acoustic path length of the objection radiation path segment serves as a basis for determining a temperature of the object between the external surface and one of the internal reflective layers due to the acoustic radiation. (App. Br. 18). We find these arguments unpersuasive because Mast suggests the use of acoustic path length for measurement of temperature (FF 5–7). Appellants identify no specific structural or unobvious functional difference Appeal 2018-002857 Application 13/393,857 10 relative to Mast based on the argued “transmission element acoustic path length principle.” That is, claim 1 recites that the controller unit functions to “detect the acoustic path length through the transmission element” and based on those measurements functions to “determine a temperature.” Mast teaches that “[i]t is well-known that the travel time of an ultrasound wave varies with the path length” and that “changes in ultrasound wave travel times may be used to estimate temperature rise” (FF 6). Thus, Mast reasonably suggests that acoustic path length measurements may be used to determine temperature (FF 6, 7). To the extent that Appellants appear to be focusing on the “acoustic path length through the transmission element” language, both Mast and Lang necessarily incorporate the path length through the transmission element, along with any further path length measurements, into their analysis (FF 3, 6, 7). Claim 1 does not exclude path lengths that extend beyond the transmission element. “[L]imitations are not to be read into the claims from the specification.” In re Van Geuns, 988 F.2d 1181, 1184 (Fed. Cir. 1993). See also In re Self, 671 F.2d 1344, 1348 (CCPA 1982) (“[A]ppellant’s arguments fail from the outset because . . . they are not based on limitations appearing in the claims.”). Conclusion of Law A preponderance of the evidence of record supports the Examiner’s conclusion that Lang and Mast render claim 1 obvious. C. and D. 35 U.S.C. § 103(a) Appellants do not separately argue these obviousness rejections, instead relying upon their arguments to overcome the combination of Lang Appeal 2018-002857 Application 13/393,857 11 and Mast. The Examiner provides sound fact-based reasoning for combining Sliwa and Barnes with Lang and Mast (see Final Act. 9–10). Having affirmed the obviousness rejection of claim 1 over Lang and Mast for the reasons given above, we also find that the further combinations with either Sliwa or Barnes renders the rejected claims obvious for the reasons given by the Examiner. SUMMARY In summary, we reverse the rejection of claims 1–10 and 14 under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1–15 of US 13/393,244 now US 9,681,923 B2, issued June 20, 2017. We affirm the rejection of claim 1 under 35 U.S.C. § 103(a) as obvious over Lang and Mast. Claims 2, 4, 5, 10, and 14 fall with claim 1. We affirm the rejection of claims 3 and 7–9 under 35 U.S.C. § 103(a) as obvious over Lang, Mast, and Sliwa. We affirm the rejection of claim 6 under 35 U.S.C. § 103(a) as obvious over Lang, Mast, and Barnes. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). AFFIRMED Copy with citationCopy as parenthetical citation