Ex Parte Vortman et alDownload PDFPatent Trial and Appeal BoardSep 27, 201712910622 (P.T.A.B. Sep. 27, 2017) 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. 12/910,622 10/22/2010 Kobi Vortman INS-061/7300942001 8522 23517 7590 09/29/2017 MORGAN, LEWIS & BOCKIUS LLP (BO) 1111 PENNSYLVANIA AVENUE, N.W. WASHINGTON, DC 20004 EXAMINER SANTOS RODRIGUEZ, JOSEPH M ART UNIT PAPER NUMBER 3737 NOTIFICATION DATE DELIVERY MODE 09/29/2017 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): kcatalano@morganlewis.com patents @ morganlewis.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte KOBI VORTMAN, SHUKI VITEK, and YOAV LEVY Appeal 2016-006976 Application 12/910,622 Technology Center 3700 Before JEFFREY N. FREDMAN, RICHARD J. SMITH, and DEVON ZASTROW NEWMAN, Administrative Patent Judges. FREDMAN, Administrative Patent Judge. DECISION ON APPEAL This is an appeal1 under 35U.S.C. § 134 involving claims to a method for ultrasound treatment of two distinct target regions within a tissue. The Examiner rejected the claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm-in-part. Statement of the Case Background “One way to apply thermal energy to internal body tissue is to focus high-intensity ultrasound waves into the tissue .... Such treatment can 1 Appellants identify the Real Party in Interest as InSightec, Ltd. (see App. Br. 2). Appeal 2016-006976 Application 12/910,622 reduce or even eliminate the need for invasive surgery to remove the tissue” (Spec. 12). “[I]t is important to avoid painful or damaging heat build-up in healthy tissues surrounding the target tissue” (id.). “Non-target tissues can often be protected by allowing cooling periods between successive sonications. Such cooling periods, however, tend to significantly prolong the total treatment time” (id. 13). “To eliminate or reduce the need for cooling periods, non-target tissues can sometimes be actively cooled” (id.). The Claims Claims 12—20, 22, 23, 26, and 35—38 are on appeal. Claim 19 is representative and reads as follows: 19. A method for ultrasound treatment of two distinct target regions within a tissue, a first target region being proximate a first, non-coolable non-target tissue and a second target region being proximate a second, coolable non-target tissue, cooling of the second non-target tissue also causing cooling of the second target region and, to a lesser extent, cooling of the first target region, and heating of either target region also causing heating of at least a tissue region surrounding the respective target region and the non-target tissue proximate thereto, the method comprising: using an ultrasound transducer, directing an ultrasound focus first into the first target region so as to heat the first target region while cooling the second non-target tissue; using a thermal imaging device, monitoring a temperature of the first non-target tissue relative to a temperature of the tissue region surrounding the first target region; and when the temperature of the first non-target tissue exceeds the temperature of the tissue region surrounding the first target region by a specified threshold as a result of a combined effect of the ultrasound focus and the cooling, interrupting ultrasound treatment of the first target region so as to avoid overheating of the first non-target tissue and re- 2 Appeal 2016-006976 Application 12/910,622 directing the ultrasound focus into the second target region so as to heat the second target region, whereby prior cooling of the second non-target tissue avoids overheating thereof. The Issue The Examiner rejected claims 12—20, 22, 23, 26, and 35—38 under 35 U.S.C. § 103(a) as obvious over Salomir,2 Chomas,3 and Chopra4 (Final Act. 2-7). The Examiner finds Salomir teaches ultrasonically “heating a target tissue . . . monitoring a temperature field in a region encompassing target tissue and non-target tissue using MRI thermometry . . . and, based on the temperature field actively adjusting temperature in a non-target region” (Final Act. 2—3). The Examiner interpreted “active adjustment to include moving ultrasound focus as well as changing the ultrasound intensity” (id. at 3). The Examiner acknowledges Salomir does “not expressly disclose plural non-target portions where active cooling is applied to one non-target portion but not to at least one non-target portion and adjusting the temperature of the first non-target portion based on the thermal responses of plural non-target portions” (id.). The Examiner finds Chomas teaches “active cooling at the skin surface to help dissipate temperature increases both at the skin surface as well as non-target portions beneath the skin surface” (id.). The Examiner interprets skin as “a plurality of tissue regions, including multiple non-target 2 Salomir et al., US 6,823,216 Bl, issued Nov. 23, 2004. 3 Chomas et al., US 2010/0106063 Al, published Apr. 29, 2010. 4 Chopra et al., US 2006/0206105 Al, published Sept. 14, 2006. 3 Appeal 2016-006976 Application 12/910,622 tissue regions as well as a non-coolable region (interpreted as being below the skin surface such that it is not directly accessible for cooling)” (id.). The Examiner finds Chopra teaches “actively cooling non-target tissue while heating a target tissue ([0011]), and redirecting ultrasound when a temperature difference reaches a specified threshold, for heating an additional target tissue” (id. at 4). The Examiner finds it obvious to modify the teaching of ultrasound therapy systems as disclosed by Salomir(’216) and the use of tissue surface cooling as disclosed by Chomas(’063) with the use of changing ultrasound focus as disclosed in Chopra(’ 105) in order to protect the neighboring skin surface as well as the underlying tissue portions not targeted during focused ultrasound therapy. (Final Act. 4—5). The issues with respect to this rejection are: Does the evidence of record support the Examiner’s conclusion that Salomir, Chomas, and Chopra render claims 19, 20, 26, and 36 obvious? Findings of Fact 1. Salomir teaches “local hyperthermia treatment by focused ultrasound, controlled by MRI” where “mapping means 200 make it possible to measure and record the spatial temperature distribution” (Salomir 4:20— 46). 2. Salomir teaches: a step 1 for estimating the heat diffusion coefficient (ai) and the absorption coefficient (012) of the focused ultrasound in the biological tissue 410; a step 2 for defining by the user, a temporal change profile of the desired temperature; 4 Appeal 2016-006976 Application 12/910,622 a step 3 for acquiring an MRI image; a step 4 for calculating the spatial distribution of the phase at the focal point 460 and in its surroundings; a step 5 for establishing the spatial temperature distribution at the focal point 460 and its surroundings; a step 6 for evaluating the temperature gradients of the focal point 460 and in its surroundings; a step 7 for determining the new power having to be delivered by the generator 120; and a step 8 for changing the energy level applied by the generator 120. Steps 3 to 8 are carried out in a loop, in order to reach and to follow the temporal change profile of the desired temperature, defined in step 2. (Salomir 6:18—36). 3. Chomas teaches an “ultrasound generator supplying ultrasound at a pressure and frequency which will heat subcutaneous tissue” and that “may include means for actively cooling the ultrasound transducer or the skin of the patient which contacts the transducer” (Chomas 113). 4. Chomas teaches: Active cooling at the skin interface may be used in any of the embodiments disclosed herein to prevent or minimize surface level heating of the skin. Active cooling can be achieved by many ways, including flowing a cooling medium such as water or the like over the transducer, flowing a cooling medium (gas or liquid) through the transducer, pre-cooling the transducer, pre-cooling the tissue, or any other method to draw heat away from the skin and transducer interface. Active cooling may be utilized while the subcutaneous tissue is being insonated with ultrasound. Active cooling may be used before or after the tissue is insonated or between treatments. (Chomas 140). 5 Appeal 2016-006976 Application 12/910,622 5. Chopra teaches “ultrasound energy is delivered to tissue volume 105 to generate a localized spatial heating pattern while tissue temperature measurements are acquired to determine and control the spatial heating pattern” (Chopra 139). 6. Figure 2 of Chopra is reproduced below: The heating applicator can be rotated about its axis to a desired angular position 208 .... The angular position 208 and angular scan rate 209 of the heating applicator 204 determine, at least in part, the spatial energy deposition. The target volume 201 can be identified in anatomical/fimctional imaging information acquired prior to treatment. A treatment volume boundary 202 is chosen so that it substantially encompasses the target volume 201 while generally sparing the surrounding or nearby tissue structures 207. The surrounding or nearby tissue structures 207 may be sensitive or critical structures that cannot or should not be damaged by the thermal therapy. The target volume 201 in 201 Fig. 2 6 Appeal 2016-006976 Application 12/910,622 this plane is treated by rotating the heating applicator across the entire region. (Chopra 148). 7. Chopra teaches: MR thermometry information is used to control the output parameters of heating applicator 106. This control allows adequate heating of the target boundary without overheating the areas near the transducer surface. For example, heating may be carried out until the temperature along the entire target boundary volume 105 is elevated beyond a threshold temperature, or thermal dose, sufficient to achieve a desired therapeutic outcome. (Chopra 145). 8. Chopra teaches: “Upon completion of the therapy, the error function is evaluated and heating re-applied to any regions of the target volume that were insufficiently heated” (Chopra 1 64). 9. Chopra teaches “a temperature control system is also available wherein coolant is provided to the heating applicator, which can be used to heat or cool the immediately adjacent tissue, as well as remove heat from the transducers” (Chopra 111). Principles of Law Although we apply the broadest reasonable interpretation during examination, “[ajbove all, the broadest reasonable interpretation must be reasonable in light of the claims and specification.” PPC Broadband, Inc. v. Corning Optical Commc’ns RF, LLC, 815 F.3d 747, 755 (Fed. Cir. 2016). 7 Appeal 2016-006976 Application 12/910,622 Analysis Claims 19 and 26 Appellants contend: “Critically, claims 19 and 26 further require separate heating of the first and second target regions” (App. Br. 9). Appellants contend “Chomas heats only a single target” (id. at 10) while “Chopra . . . does not interrupt heating of one target to heat another target” (id. at 12). The Examiner responds “Chopra specifically discloses (as seen in Fig. 2 []) that a treatment lesion 203 can be made using the transducer 205. Then, the transducer can be rotated (see 206) such that additional treatment lesions can be made in a pattern and the whole treatment region 202 is completely treated” (Ans. 9). We find that Appellants have the better position. While Chopra teaches, regarding Figure 2, that the “target volume 201 in this plane is treated by rotating the heating applicator across the entire region” (FF 6), we agree with Appellants that Chopra does not suggest the rotation is performed to separately heat a second target region to avoid overheating of “non- coolable” non-target tissue nor does Chopra suggest the redirection of the rotation is towards tissue adjacent to cooled tissue. (Reply Br. 6.) The Examiner provides no reason, based on teachings in the prior art, to perform these steps as required by claims 19 and 26. Instead, Chopra treats the entire regions 201 and 202 as a single target region as shown in Figure 2, and identifies only region 207 as non-target tissue (FF 6). Therefore, Chopra lacks a teaching or suggestion to redirect rotation for overheating, much less a teaching that when the redirection 8 Appeal 2016-006976 Application 12/910,622 occurs, the heating should focus on a target region adjacent an already cooled, second non-target tissue as required by claims 19 and 26. The Examiner also does not identify any teachings in Salomir or Chomas suggesting that when redirecting heating by ultrasound occurs, that such redirection should focus on targets adjacent already cooled non-target tissue. Claims 20 and 36 Appellants contend “Chopra also fails to disclose or suggest a differential response to cooling, nor does Chopra disclose or suggest a cycle of cooling, treatment, and deactivating cooling” (App. Br. 14—15). We note that claim interpretation is “a question of law reviewed de novo.” Pfizer, Inc. v. leva Pharmaceuticals, USA, Inc., 429 F.3d 1364, 1372 (Fed. Cir. 2005). Claim 20 recites a method “comprising at least one treatment cycle” and system claim 36 recites “at least one control cycle.” We interpret “at least one” as encompassing the situation where a single treatment cycle is performed. Thus, because claims 20 and 36 do not require repetition of the treatment cycles, we are not persuaded that the proposed combination fails to disclose a single cycle comprising the three recited steps. Chopra suggests using equipment for active cooling to “cool the immediately adjacent tissue” (FF 9), where the adjacent tissue is non-target tissue. Chopra teaches using ultrasound “to generate a localized spatial heating pattern” (FF 5). Chomas teaches that “[ajctive cooling may be utilized while the subcutaneous tissue is being insonated with ultrasound. Active cooling may be used before or after the tissue is insonated or between treatments” (FF 4). Thus, Chopra and Chomas reasonably render obvious a 9 Appeal 2016-006976 Application 12/910,622 method that comprises performing at least a single cycle in which non-target tissue is cooled (FF 9), subsequently using ultrasound to heat target tissue (FF 5), and stopping cooling of non-target tissue at some point after heating has occurred (FF 4). We recognize, but find unpersuasive, Appellants’ argument that the “notion of cooling activation and de-activation cycles — much less the notion of doing so to limit applied energy levels and avoid overheating — is utterly outside the disclosure of Chomas” (Reply Br. 7). While we agree that performing the process over multiple cycles is not suggested by the combination of Salomir, Chomas, and Chopra, claims 20 and 36 encompass the embodiment where a single cycle is performed. See In re Self, 671 F.2d 1344, 1348 (CCPA 1982) (“[Ajppellanf s arguments fail from the outset because . . . they are not based on limitations appearing in the claims.”). Conclusion of Law The evidence of record does not support the Examiner’s conclusion that Salomir, Chomas, and Chopra render claims 19 and 26 obvious. The evidence of record supports the Examiner’s conclusion that Salomir, Chomas, and Chopra render claims 20 and 36 obvious. SUMMARY In summary, we reverse the rejection of claims 15, 19, 26, 37, and 38 under 35 U.S.C. § 103(a) as obvious over Salomir, Chomas, and Chopra. We affirm the rejection of claims 20 and 36 under 35 U.S.C. § 103(a) as obvious over Salomir, Chomas, and Chopra. Claims 12—14, 16—18, 22, 23, and 35 fall with claims 20 and 36. 10 Appeal 2016-006976 Application 12/910,622 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-IN-PART 11 Copy with citationCopy as parenthetical citation