Ex Parte Ostrovsky et alDownload PDFPatent Trial and Appeal BoardSep 26, 201611397122 (P.T.A.B. Sep. 26, 2016) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 111397, 122 0410312006 93427 7590 09/28/2016 Brake Hughes Bellermann LLP c/o CPA Global 900 Second A venue South Suite 600 Minneapolis, MN 55402 FIRST NAMED INVENTOR Issac Ostrovsky 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. 0073-311001 5687 EXAMINER SMITH, RUTHS ART UNIT PAPER NUMBER 3737 NOTIFICATION DATE DELIVERY MODE 09/28/2016 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): docketing@brakehughes.com uspto@brakehughes.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte ISSAC OSTROVSKY, TY F AIRNENY, and VICTOR SHUKHAT Appeal2014-000905 Application 11/397,122 Technology Center 3700 Before ERIC B. GRIMES, RICHARD M. LEBOVITZ, and TIMOTHY G. MAJORS, Administrative Patent Judges. LEBOVITZ, Administrative Patent Judge. DECISION ON APPEAL This appeal involves claims directed to a device for heating target tissue. The Examiner finally rejected the claims as obvious under 35 U.S.C. § 103(a). We have jurisdiction under 35 U.S.C. § 134. The obviousness rejection is affirmed-in-part. STATEMENT OF CASE Appellants appeal from the Examiner's final rejection of claims 1---6 and 8-1 7. The claims stand rejected under 3 5 U.S. C. § 1 0 3 (a) (pre-AIA) as obvious in view of U.S. Patent No. 4,938,217 (patented Appeal2014-000905 Application 11/397,122 Jul. 3, 1990) to Lele (hereinafter "Lele") and U.S. Patent No. 5,873,845 (patented Feb. 23, 1999) to Cline et al. (hereinafter "Cline"). Final Rej. 2--4. Claim 1 is representative and reads as follows: 1. A device for heating target tissue comprising: a housing including a tissue contacting surface; an array of ultrasound transducers mounted within the housing on an array surface shaped so that ultrasound energy from the transducers converges on a target area a predetermined depth from the tissue contacting surface; and a deflector member attached to the housing and extending into a selected field through which the ultrasound energy passes on its way to the target area, the deflector member refracting a selected portion of the ultrasound energy to increase a distance of separation between the array and a proximal edge of a region at which a level of ultrasound energy exceeds a predetermined threshold level relative to an undeflected distance of separation when the deflector member is not attached to the housing. Claims 1, 8, and 17 Claims 1 and 1 7 are directed to a device for heating tissue that comprises a housing, an array of ultrasound transducers mounted within the housing, and a deflector member attached to the housing. The transducers are "shaped so that ultrasound energy from the transducers converges on a target area a predetermined depth from the tissue contacting surface" of the housing. In claim 1, the deflector member is recited to have the following characteristic: refracting a selected portion of the ultrasound energy to increase a distance of separation between the array and a proximal edge of a region at which a level of ultrasound energy 2 Appeal2014-000905 Application 11/397,122 exceeds a predetermined threshold level relative to an undeflected distance of separation when the deflector member is not attached to the housing. As shown in the Figs. 2a and 2b, and explained in paragraphs 24 to 28 of the Specification, the deflector refracts a selected portion of the ultrasound energy, and by doing so, increases the distance between the array of the ultrasound transducer and a region in the target area of the subject ("proximal edge of a region") as compared to when the deflector is not present ("undeflected distance"). Consequently, we interpret the recited limitation to require an increase in the distance between these two regions (the "array" and the "proximal edge of a region") when the deflector is present. Claim 17 also requires a deflector which "refract[ s] a selected portion of the ultrasound energy selected to increase a distance of separation between the array and a proximal edge of a region at which a level of ultrasound energy exceeds a predetermined threshold level." Claim 8 has a similar limitation as in claim 1 that the deflector ("deflective shield member") "control[ s] a distance of separation between the array and a proximal edge of a region at which a level of ultrasound energy exceeds a predetermined threshold level." Because claims 1, 8, and 17 each require a deflector which changes the distance of separation between the array of transducers and a region in the target area, we have considered them as a group. Claim 9 Claim 9 is directed to a device for heating tissue that comprises an array of ultrasound transducers mounted within a housing and a deflector. 3 Appeal2014-000905 Application 11/397,122 The array of transducers is "shaped so that ultrasound energy from the transducers converges on a target area a predetermined distance from the array." The deflector is recited to have the following characteristic: a shape and location relative to the array selected so that a shape of a region of the target area within which an intensity of ultrasound energy from the transducers exceeds a predetermined threshold level corresponds to a desired shape of a lesion to be created in the target tissue. Claim 9, unlike claims 1, 8, and 17, does not require the deflector to change the distance of a separation between the transducers and a region in the target area (the "proximal edge of a region"). Rather, in claim 9, the deflector controls "a shape of a region of the target area." REJECTION The Examiner found that Lele describes an ultrasound therapy device comprising a transducer for heating tissue corresponding to the device recited in all the rejected claims. Final Rej. 2. The Examiner also found that Lele describes placing materials between the array and tissue treatment area to block selected portions of the transducer beams. Id. The Examiner found that Lele does not describe a deflector. Id. However, the Examiner found that Cline describes a deflector (refraction plate) mounted to transducers which "refracts portions of the [transducer] beam to control its focus and create a desired lesion geometry." Id. The Examiner determined it would have been obvious to one of ordinary skill in the art to include Cline's deflector in Lele "to control the focus of the treatment beam such that a desired lesion geometry is created." Id., 3. Appellants contend that Cline's refraction plate, as well as the disclosed shell lens, changes the diameter of the focal region, but not the distance of separation between the transducers and region in a target area 4 Appeal2014-000905 Application 11/397,122 ("proximal edge of a region") as required by the claim 1, 8, and 17. Appeal Br. 6-7. With respect to claim 9, Appellants contend that Cline's refraction plate and lens "merely increase[] a volume (e.g., diameter) of a focal region" but "neither ... has a shape selected so that the focal region corresponds to a desired shape of a lesion to be created in the target tissue." Id., 9. The issue in this rejection is whether Cline describes a deflector which meets the limitations of claim 1, 8, 9, and 17. DISCUSSION In response to Appellants' argument distinguishing Cline's deflector from the claimed deflector, the Examiner stated that the recited limitation "is not a structural limitation but rather a functional limitation." Ans. 5. The Examiner stated that the claims must distinguish the prior art by structure rather than function. Id. The Examiner found that "the deflector member of Cline would be capable of functioning as set forth in the modified device of Lele." Id. All the rejected claims require a deflector. The deflector is a structure. The function of the deflector in claims 1, 8, and 17 is to change the distance between the transducer array and a region in the target area. The Examiner characterized this requirement as a functional limitation rather than a structure. However, while it is true that the deflector's activity in the claimed device is stated only in functional words, the function must be accomplished with a specific structure. The Specification gives examples of deflector structures that perform this function, for example, elongated and 5 Appeal2014-000905 Application 11/397,122 cylindrical members. Spec. iii! 21, 22, 29. The Specification teaches that the described structures perform the recited function. Id., iii! 24--28. "A patent applicant is free to recite features of an apparatus either structurally or functionally." In re Schreiber, 128 F.3d 1473, 1478 (Fed. Cir. 1997). However, the court noted "choosing to define an element functionally, i.e., by what it does, carries with it a risk." Id. Specifically, the court quoted from In re Swinehart, 439 F.2d 210, 212 (CCPA 1971) (id.): where the Patent Office has reason to believe that a functional limitation asserted to be critical for establishing novelty in the claimed subject matter may, in fact, be an inherent characteristic of the prior art, it possesses the authority to require the applicant to prove that the subject matter shown to be in the prior art does not possess the characteristic relied on. While these statements by the court were made in the context of anticipation, the same reasoning applies when a rejection is based on obviousness. Thus, it is permissible for a patent applicant to distinguish prior art based on a :thnctional limitation. However; if the Examiner has basis to believe that the function is performed by the prior art structure, the Examiner can require the applicant to prove that it does not. The issue in this rejection therefore is whether the Examiner had sufficient basis to believe that Cline's refraction plate and shell lens perform the recited function of the claimed deflector. The following findings of fact from Cline are pertinent to this determination. FPL "FIG. 4a shows one embodiment of the invention using a spherical refraction plate 410 situated between transducer 80 and subject 200 ... Refraction plate 410 effectively increases the diameter 416 of focal region 420." Cline, col. 3, 11. 39--47. 6 Appeal2014-000905 Application 11/397,122 FF2. "FIG. 4b [reproduced below] illustrates the expanded focal region generated by refraction plate 410 ofFIG.4a." Id., col. 3, 11. 51-53 . ............ FlG.4b "[R]efraction plate 410 forms four focal regions 432, 434, 436, and 438, as shown in FIG. 4b, ... effectively expanding the focal area of the transducer." Id., col. 4, 11. 10-13. FF3. "FIGS. 6a, 6b illustrate a focused ultrasound phased shell lens 600 that also increases the treatment volume of the transducer. Phased shell lens 600 creates a larger beam in the radial dimension while maintaining the axial dimension of focal region 12 (FIG. 1)." Id., col. 4, 11. 58--60. As indicated by Findings of Fact 1 and 2, the refraction plate expands the diameter of the focal region produced by the transducer. There is no disclosure that "a distance of separation" between the transducers and focal region is changed by the refraction plate. Finding of Fact 3 expressly teaches that the phased shell lens increases the radial dimension without changing the axial dimension. In other words, the diameter ("radial dimension") of the focal region is changed by the shell lens, not the "distance of separation" between the transducers and focal region ("axial dimension.") 7 Appeal2014-000905 Application 11/397,122 In sum, the disclosure in Cline does not support a "reason to believe that a functional limitation [is] an inherent characteristic of the prior art." Swinehart, 439 F.2d at 212. The Specification, as discussed above, describes elongated and cylindrical structures for performing the recited function. Spec. i-fi-1 21, 22, 29. Cline, however, describes spherical and shell shapes for increasing the diameter and radial dimension of the focal region of the transducer. FF 1, FF3. The Examiner did not explain how these different structures would give rise to a reason to believe that the deflector member of Cline would be capable of functioning in the manner recited in claims 1, 8, and 17. Ans. 5. The Examiner did not provide sufficient evidence that Cline's refraction plate and phased shell lens "increase a distance of separation between the array and a proximal edge of a region at which a level of ultrasound energy exceeds a predetermined threshold level relative to an undeflected distance of separation when the deflector member is not attached to the housing" as required by claim 1. Consequently, the rejection of claim 1 is reversed. Claims 8 and 17, and dependent claims 2---6, and 10- 16 are reversed for the same reasons. Claim 9 Claim 9 requires the deflector to have a shape and location relative to the array selected so that a shape of a region of the target area within which an intensity of ultrasound energy from the transducers exceeds a predetermined threshold level corresponds to a desired shape of a lesion to be created in the target tissue. 8 Appeal2014-000905 Application 11/397,122 Cline teaches that the refraction plate and shell lens change the diameter and radial dimension of the focal region. FF 1-FF3. A change in the diameter or radius of the focus region is "a shape of a region of a target area" and thus would change the corresponding "desired shape of a lesion to be created in the target tissue." Appellants contend that Cline does not teach this limitation, but do not explain or provide evidence that would distinguish the recited "shape of a region" and "shape of a lesion" from the change in the shape of the focal region described in Cline. Consequently, we affirm the rejection of claim 9 as obvious in view of Lele and Cline. TIME PERIOD 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-IN-PART 9 Copy with citationCopy as parenthetical citation