Ex Parte Sverdlik et alDownload PDFPatent Trials and Appeals BoardMay 9, 201912449725 - (D) (P.T.A.B. May. 9, 2019) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 12/449,725 08/24/2009 67801 7590 05/13/2019 MARTIN D. MOYNIHAN d/b/a PRTSI, INC. P.O. BOX 16446 ARLINGTON, VA 22215 FIRST NAMED INVENTOR Ariel Sverdlik 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. 46828 1866 EXAMINER IP,JASONM ART UNIT PAPER NUMBER 3793 NOTIFICATION DATE DELIVERY MODE 05/13/2019 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): usptomail@ipatent.co.il PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte ARIEL SVERDLIK, SHMUEL EINA V, ZEEV ARONIS, RAN KORNOWSKI, and IFAT LAVI Appeal2017-008059 Application 12/449,725 Technology Center 3700 Before LYNNE H. BROWNE, MICHELLE R. OSINSKI, and LEE L. STEPINA, Administrative Patent Judges. OSINSKI, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Ariel Sverdlik et al. ("Appellants") 1 appeal under 35 U.S.C. § 134(a) from the Examiner's decision rejecting claims 1, 3, 4, 8-11, 14--22, 25-27, 29, 31, 34, 39, 41, 43--46, 48-50, 52-57, 59, and 61-80. 2 An oral hearing 1 According to Appellants, "[t]he real parties in interest are Ramot at Tel- Aviv University Ltd .... which is the owner of the application, and CardioSonic Ltd .... which is the exclusive licensee." Appeal Br. 2. 2 Claims2,5-7, 12, 13,23,24,28,30,32,33,35-38,40,42,47,51,58,and 60, are cancelled. Response to Final Filed in Conjunction with RCE (May 26, 2015), 2-8. Appeal2017-008059 Application 12/449,725 was held on April 18, 2019. We have jurisdiction over the appeal under 35 U.S.C. § 6(b). We REVERSE. THE CLAIMED SUBJECT MATTER Claims 1 and 34 are independent. Claim 1, reproduced below, is illustrative of the subject matter on appeal. Tu 1. A method of applying ultrasound energy to an inner surface of a blood vessel wall to treat a target tissue, the method compnsmg: providing an ultrasound emitter adapted to emit non- focused ultrasound energy, wherein said providing comprises selecting parameters of said energy to treat said target tissue when said emitter is positioned at a distance from an intima of said blood vessel; heating at least a portion of the target tissue located in an adventitia or further away from an intima of the blood vessel without causing thermal necrosis of said intima, using said non- focused ultrasound energy delivered intrabody, by positioning said ultrasound emitter at a distance from said intima selected for treating said target tissue using said energy, without said ultrasound emitter contacting said intima during said heating so as to allow blood flow between said emitter and said intima to cool non-targeted tissue. Phelps EVIDENCE US 6,235,024 B 1 US 6,475,210 Bl May 22, 2001 Nov. 5, 2002 Mar. 27, 2003 June 9, 2005 Oct. 6, 2005 July 19, 2007 Loeb Weitzel Capuano Stevens-Wright US 2003/0060813 Al US 2005/0124892 Al US 2005/0222649 Al US 2007/0167940 Al 2 Appeal2017-008059 Application 12/449,725 REJECTIONS I. Claims 1, 3, 4, 8-11, 14--22, 25-27, 29, 31, 34, 39, 41, 43--46, 48- 50, 52-57, 59, and 61-80 stand rejected under 35 U.S.C. § 112, second paragraph, as being indefinite. Non-Final Act. 7. II. Claims 1, 4, 14, 25-27, 29, 31, 34, 39, 41, 43, 48, 59, 61, 65---69, 74, and 76-80 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Tu and Stevens-Wright. Id. at 7-12. III. Claims 3 and 17-19 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Tu, Stevens-Wright, and Loeb. Id. at 12-13. IV. Claims 8 and 9 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Tu, Stevens-Wright, and Weitzel. Id. at 13. V. Claims 10, 11, 15, 20, 44--46, 49, 52-57, 62---64, 70, and 75 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Tu, Stevens-Wright, and Phelps. Id. at 13-17. VI. Claims 16, 21, 22, and 50 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Tu, Stevens-Wright, and Capuano. Id. at 17- 18. VII. Claims 71 and 72 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Tu, Stevens-Wright, Phelps, and Weitzel. Id. at 19. VIII. Claim 73 stands rejected under 35 U.S.C. § 103(a) as unpatentable over Tu, Stevens-Wright, Phelps, and Loeb. Id. at 19-20. 3 Appeal2017-008059 Application 12/449,725 OPINION Rejection I The Examiner rejects independent claims 1 and 34, and their dependent claims, under 35 U.S.C. § 112, second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention. Non- Final Act. 7. In particular, the Examiner points to the recitation of the ultrasound emitter being "positioned at a distance from an intima of said blood vessel ... without said ultrasound emitter contacting said intima during ... heating so as to allow blood flow between said emitter and said intima to cool non-targeted tissue." Appeal Br. 22 (Claims App.); Non-Final Act. 7. The Examiner asserts that because "'distance' is not assigned a particular value or range, [it] can be zero" and "it is unclear as to how a zero distance would allow blood flow between a tissue surface and the emitter." Non-Final Act. 7. Appellants respond that a person of skill in the art "would immediately understand that ... the plain meaning of the term [']distance['] in these claims cannot include a zero distance as it would not allow blood flow, nor is it 'away."' Appeal Br. 7. We agree that one skilled in the art would understand claims 1 and 34 to reasonably convey that the distance must be something other than zero so as to avoid contact of the ultrasound emitter with the intima and to allow blood flow between the intima and ultrasound emitter. Accordingly, we do not sustain the Examiner's rejection of claims 1 and 34, and their dependent claims, under 35 U.S.C. § 112, second 4 Appeal2017-008059 Application 12/449,725 paragraph, as failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention. Rejection II The Examiner finds, among other things, that Tu teaches "a catheter method and system of applying ultrasound energy to an inner circumferential surface of a blood vessel wall to treat a target tissue." Non- Final Act. 7-8. The Examiner finds that Tu teaches "providing an ultrasound emitter adapted to emit ultrasound energy" and that the ultrasound energy be "delivered intrabody." Id. at 8. As to the ultrasound energy being non-focused, the Examiner determines that one of ordinary skill in the art "would have found it obvious to employ a beam that is of an appropriate geometry in order to effectively treat the tissue being targeted." Id. The Examiner made findings that "one of ordinary skill would understand that both a non-focused beam and a focused beam are both common implementations of ultrasound" and "an unfocused beam carries a lower intensity than a focused beam, and therefore an unfocused beam is less susceptible to causing damage compared to a focused beam at the point of focus." Applicant-Initiated Interview Summary (Aug. 28, 2015). As to heating target tissue that is "located in an adventitia or further away from an intima of the blood vessel without causing thermal necrosis of said intima," as claimed, the Examiner points out that Tu "teach[ es] that the heating is performed within a blood vessel" (Non-Final Act. 8 (citing Tu, 2:58-3 :5)) and "safely performing the heating is considered" (id. ( citing Tu, 2:7-12)). The Examiner concludes that it would have been obvious to one of ordinary skill in the art "to apply ultrasound in a safe and controlled manner within a blood vessel, so as to provide proper treatment tools." Id. 5 Appeal2017-008059 Application 12/449,725 As to positioning the ultrasound emitter at a distance from an intima of the blood vessel without the ultrasound emitter contacting the intima, the Examiner finds that "Stevens-Wright teaches an energizing device placed a distance away from a wall, allowing blood flow to cool said energizing device." Id. (citing Stevens-Wright ,r 52, Fig. 3). The Examiner concludes that it would have been obvious "to apply the spacing of Stevens-Wright, so as to prevent overheating of an energizing device." Id. The Examiner also asserts that "there is motivation to combine Tu and Stevens-Wright because both are directed to intravascular therapy where controlling the amount of heat applied to tissue would be an important consideration in caring for a subject's safety." Id. at 6. The Examiner explains that Stevens-Wright teaches the "known technique" of "allowing the spontaneous conduction of thermal energy, or heat, from one hotter body [i.e., the intima] to a cooler body [i.e., the blood within the vessel that is in motion]." Ans. 16. According to the Examiner, "Stevens-Wright is brought [in] to remedy the deficiency of Tu by teaching that a gap between tissue surface and an ablative device allows blood to flow into said gap and thus aid in the cooling of said tissue surface." Id. at 20. "The combination being made between Tu and Stevens-Wright is that of Tu's intravenous ultrasound ablation instrument and the manner of placing an ablation instrument intravenously as taught by Stevens-Wright." Id. at 23. With respect to the Examiner's first articulated reason for applying the spacing of Stevens-Wright to Tu' s device-namely, to prevent overheating of the energizing device (Non-Final Act. 8), Appellants argue that "[t]he most Tu would learn from Stevens-Wright is to space the ablation element away from the surface when in the radiofrequency ablation mode." Reply 6 Appeal2017-008059 Application 12/449,725 Br. 2 ( emphasis omitted). We agree with Appellants in that the difference in the energizing device of Tu and Stevens-Wright calls into question the basis of the Examiner's articulated reasoning. Even to the extent that one could potentially argue that Stevens-Wright's statement that "[b ]lood flow ... may cool ... ring electrode 20" (Stevens-Wright ,r 52) is a suggestion that such a ring electrode is susceptible to overheating and needs to be cooled (a position with which we do not necessarily agree), Stevens-Wright discusses the cooling only in connection with the application of RF energy by the ring electrode (id.). This disclosure in Stevens-Wright provides no indication that overheating of, in particular, an ultrasound emitter is a problem that needs to be addressed. As to the Examiner's second articulated reason for applying the spacing of Stevens-Wright to Tu's device-namely, that controlling the amount of heat applied to tissue would be an important consideration in caring for a subject's safety and that the spacing would allow for cooling of the tissue surface (Non-Final Act. 6; Ans. 20), Appellants argue, contrary to the Examiner's finding (id.), that Tu does not even consider increased temperature at the tissue surface and/or ensuring the safety of a patient to be a problem for several reasons. First, "Tu teaches the desirability of surface ablation using RF." Appeal Br. 13 (citing Tu 3: 12-17). More particularly, Appellants argue that "Tu's specific objective is not to avoid damage to the intima [because] [ d]amage to the intima is exactly what he is trying to achieve." Id. at 14 (italics omitted). Second, Appellants argue that Tu already utilizes a temperature sensor for feedback for accomplishing the objective of controlling the amount of heat applied to tissue, such that Stevens-Wright's teachings add nothing to Tu's catheter. Id. at 13 (citing 7 Appeal2017-008059 Application 12/449,725 Tu, 3:7-12). Appellants point out that Tu solves his problem of "control[ling] the amount of damage in the context of a unitary RF-US emitter that must be in contact with the intima for the EF energy [to] be effective" by "use of a temperature sensor-control system (which requires contact)." Id. at 14. Third, Appellants argue (Appeal Br. 14) that Tu explicitly states that: Ablative treatment apparatus have an advantage because of the use of a therapeutic energy that is rapidly dissipated and reduced to a non-destructive level by conduction and convection, to other natural processes. Tu, 2:11-15. Appellants continue that "[ifJ this [statement in Tu] teaches anything, it is that pre-Tu art did not regard safety as an issue, because heat is dissipated by natural processes." Appeal Br. 14. We agree with Appellants that the Examiner's articulated reasoning for modifying Tu's catheter system having dual ablation capability of RF ablation and ultrasound ablation so as to include a space or gap between the ablative element and the tissue surface lacks rational underpinnings. The evidence falls short of supporting a conclusion that one of ordinary skill in the art would have viewed cooling of surface tissue in connection with the application of ultrasound energy ablation and/or ensuring the safety of a patient to be a problem requiring a solution in light of (i) the desire in Tu to ablate surface tissue; (ii) Tu's use of a temperature feedback control system, and (iii) Tu's recognition of the dissipation of heat via natural processes. The Examiner has also indicated that the proposed modification to Tu is the application of a known technique (Stevens-Wright's teaching of allowing the conduction of thermal energy or heat from the intima of a blood vessel to the blood) to a known device ready for improvement (Tu's catheter 8 Appeal2017-008059 Application 12/449,725 system having dual ablation capability) to yield predictable results or the use of the known technique to improve similar devices in the same way. Ans. 16. We, however, do not find this reasoning, alone, to sufficiently articulate why one skilled in the art would have modified Tu's catheter. The evidence falls short to support the similarity of Tu and Stevens-Wright's devices. The evidence also falls short to support that the results of the application of the known technique would yield predictable results. That is, the Examiner has not explained sufficiently how Stevens-Wright's teaching of blood flow cooling the tissue surface would be seen as an improvement, and especially an improvement that would have applicability to Tu's dual ablation catheter system (i.e., how Stevens-Wright's mere mention that blood flow may cool tissue surface and ring electrodes in connection with the application of RF energy is an indication that it would improve or benefit Tu's device in connection with ultrasound ablation, especially where Tu's device requires tissue contact and already has other means for controlling temperature at the tissue surface). See Reply Br. 6 ("[T]he cited devices use different energy modalities at different setups for obtaining a different effect on tissue."). The Examiner has failed to articulate reasoning with rational underpinnings relating to the use of a "known technique" to support that the proposed combination would have been obvious. The Examiner has also indicated that the proposed modification to Tu is simply the known work in one field of endeavor (Stevens-Wright's teaching of allowing the conduction of thermal energy or heat from the blood vessel intima to the blood) prompting a predictable variation for use in the same or a different field (Tu's catheter system having dual ablation capability) based on design incentives. Ans. 16. Appellants argue that "it is 9 Appeal2017-008059 Application 12/449,725 not clear what design incentives would apply here." Reply Br. 6. We agree that the evidence falls short to support that there are design incentives or market forces which would have prompted adaptation of Tu's dual capability ablation catheter system. Thus, the Examiner has not provided an adequate articulation of a reason why a person of ordinary skill in the art would have been led to modify Tu's dual capability ablation catheter system so as to position the ultrasound emitter at a distance from the intima of a blood vessel so as to allow blood flow therebetween, as called for in independent claims 1 and 34. For the foregoing reasons, the rejection of independent claims 1 and 34 under 35 U.S.C. § 103(a) as unpatentable over Tu and Stevens-Wright is not sustained. We also do not sustain the rejection of claims 4, 14, 25-27, 29, 31, 39, 41, 43, 48, 59, 61, 65---69, 74, and 76-80 which depend therefrom, and for which the Examiner relies on the same reasoning in support of the combination of references that we found deficient in connection with the independent claims. Non-Final Act. 7-12. Rejections III-VIII The Examiner's rejections of claims 3, 8-11, 15-22, 44--46, 49, 50, 52-57, 62---64, 70-73, and 75 rely on the same proposed modification of Tu in view of Stevens-Wright and the same reasoning in support of the combination of references that we found deficient in connection with the independent claims. Non-Final Act. 12-20. The Examiner does not explain how Loeb, Weitzel, Phelps, and/or Capuano would remedy the deficiency of the combination of Tu and Stevens-Wrights. Id. Accordingly, we do not sustain, under 35 U.S.C. § 103(a), the rejections of: claims 3 and 17-19 as unpatentable over Tu, Stevens-Wright, 10 Appeal2017-008059 Application 12/449,725 and Loeb; claims 8 and 9 as unpatentable over Tu, Stevens-Wright, and Weitzel; claims 10, 11, 15, 20, 44--46, 49, 52-57, 62---64, 70, and 75 as unpatentable over Tu, Stevens-Wright, and Phelps; claims 16, 21, 22, and 50 as unpatentable over Tu, Stevens-Wright, and Capuano; claims 71 and 72 as unpatentable over Tu, Stevens-Wright, Phelps, and Weitzel; and claim 73 as unpatentable over Tu, Stevens-Wright, Phelps, and Loeb. DECISION The Examiner's decision to reject claims 1, 3, 4, 8-11, 14--22, 25-27, 29, 31, 34, 39, 41, 43--46, 48-50, 52-57, 59, and 61-80 35 U.S.C. § 112, second paragraph, as being indefinite is REVERSED. The Examiner's decision to reject claims 1, 4, 14, 25-27, 29, 31, 34, 39, 41, 43, 48, 59, 61, 65-69, 74, and 76-80 under 35 U.S.C. § 103(a) as unpatentable over Tu and Stevens-Wright is REVERSED. The Examiner's decision to reject claims 3 and 17-19 under 35 U.S.C. § 103(a) as unpatentable over Tu, Stevens-Wright, and Loeb is REVERSED. The Examiner's decision to reject claims 8 and 9 under 35 U.S.C. § 103(a) as unpatentable over Tu, Stevens-Wright, and Weitzel is REVERSED. The Examiner's decision to reject claims 10, 11, 15, 20, 44--46, 49, 52-57, 62---64, 70, and 75 under 35 U.S.C. § 103(a) as unpatentable over Tu, Stevens-Wright, and Phelps is REVERSED. The Examiner's decision to reject claims 16, 21, 22, and 50 under 35 U.S.C. § 103(a) as unpatentable over Tu, Stevens-Wright, and Capuano is REVERSED. 11 Appeal2017-008059 Application 12/449,725 The Examiner's decision to reject claims 71 and 72 under 35 U.S.C. § 103 (a) as unpatentable over Tu, Stevens-Wright, Phelps, and Weitzel is REVERSED. The Examiner's decision to reject claim 73 under 35 U.S.C. § 103(a) as unpatentable over Tu, Stevens-Wright, Phelps, and Loeb is REVERSED. REVERSED 12 Copy with citationCopy as parenthetical citation