Ex Parte Raju et alDownload PDFPatent Trial and Appeal BoardJul 7, 201713501571 (P.T.A.B. Jul. 7, 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. 13/501,571 04/12/2012 Balasundara Iyyavu Raju 2009P01453WOUS 2947 24737 7590 07/11/2017 PTTTT TPS TNTFT T FfTTTAT PROPFRTY fr STANDARDS EXAMINER 465 Columbus Avenue PENG, BO JOSEPH Suite 340 Valhalla, NY 10595 ART UNIT PAPER NUMBER 3786 NOTIFICATION DATE DELIVERY MODE 07/11/2017 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 BALASUNDARAIYYAVU RAJU, SHIWEI ZHOU, and SHUNMUGAVELU SOKKA Appeal 2016-003262 Application 13/501,571 Technology Center 3700 Before DONALD E. ADAMS, JEFFREY N. FREDMAN, and RICHARD J. SMITH, Administrative Patent Judges. FREDMAN, Administrative Patent Judge. DECISION ON APPEAL This is an appeal1 under 35 U.S.C. § 134 involving claims to an ultrasound power supply. The Examiner rejected the claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. Statement of the Case Background “The invention provides for an ultrasound power supply adapted for supplying electrical power for driving an ultrasound transducer in contact with a subject” (Spec. 3:1—2). 1 Appellant identifies the Real Party in Interest as Koninklijke Philips, N.V., (see App. Br. 2). Appeal 2016-003262 Application 13/501,571 The Claims Claims 1—15 are on appeal. Claim 1 is representative and reads as follows: 1. An ultrasound power supply adapted for supplying electrical power for driving an ultrasound transducer in contact with a subject, the ultrasound power supply comprising: a communications interface adapted for receiving a first temperature measurement of a first volume of the subject, wherein the first volume is a first defined volume within an imaging volume of the subject, and a second temperature measurement of a second volume of the subject, wherein the second volume is a second defined volume within the imaging volume of the subject, wherein the first volume is located between the ultrasound transducer and the second volume; a controller adapted for modulating the output of electrical power for driving the ultrasound transducer such that via ultrasonic heating by the ultrasound transducer: a. the first temperature measurement is maintained above a first predetermined threshold, b. the first temperature measurement is maintained below a second predetermined threshold, and c. the second temperature measurement is maintained below a third predetermined threshold; and wherein the first predetermined threshold is above the third predetermined threshold. 2 Appeal 2016-003262 Application 13/501,571 The issues A. The Examiner rejected claims 1, 3—6, 8, 9, 11, and 13—15 under 35 U.S.C. § 103(a) as obvious over Chopra2 and Chen3 (Final Act. 3—9). B. The Examiner rejected claim 2 under 35 U.S.C. § 103(a) as obvious over Chopra, Chen, and Trachtenberg4 (Final Act. 9-11). C. The Examiner rejected claim 7 under 35 U.S.C. § 103(a) as obvious over Chopra, Chen, and Slayton5 (Final Act. 11—12). D. The Examiner rejected claim 10 under 35 U.S.C. § 103(a) as obvious over Chopra, Chen, and Carl6 (Final Act. 12—13). E. The Examiner rejected claim 12 under 35 U.S.C. § 103(a) as obvious over Chopra, Chen, Slayton, and Schneider7 (Final Act. 13—14). A. 35 U.S.C. § 103(a) over Chopra and Chen The Examiner finds Chopra teaches: an ultrasound system for driving an ultrasound transducer in contact with a subject, and the system comprises a communications interface adapted for receiving a first temperature measurement of a first volume of the subject, wherein the first volume is a first defined volume within an imaging volume of the subject (fig. 2, volumes inside 201, or fig. 7, inside target boundary, para 0061) and a second temperature measurement of a second volume of the subject, wherein the second volume is a second defined volume within 2 Chopra et al., US 2006/0206105 Al, published Sept. 14, 2006. 3 Chen et al., US 2003/0212390 Al, published Nov. 13, 2003. 4 Trachtenberg, J., WO 00/28919 Al, published May 25, 2000. 5 Slayton et al., US 6,623,430 Bl, issued Sept. 23, 2003. 6 Carl, A., US 2002/0095144 Al, published July 18, 2002. 7 Schneider et al., US 2002/0077588 Al, published June 20, 2002. 3 Appeal 2016-003262 Application 13/501,571 the imaging volume of the subject (fig. 2, volumes outside of 202, or fig. 7, outside of 704 boundary, para 0061). (Final Act. 3—4). The Examiner finds Chopra teaches a controller “adapted for modulating the output of electrical power by continually varying the power . . . wherein the first temperature measurement is maintained between the first predetermined threshold and second predetermined threshold and the second temperature measurement is maintained below the third predetermined threshold” (Final Act. 4—5). The Examiner acknowledges that Chopra “fails to teach a power supply and a controller to control ultrasound by changing voltage and current” (Final Act. 5). The Examiner finds Chen teaches a “DC power supply 34 furnishes the necessary power to both the RF board 36 and the ultrasound board 50” (Id.). The Examiner finds it obvious to modify Chopra with the “controllable power supply features of Chen ‘390 in order to control the ultrasound transducer by controlling the power supply” (Final Act. 6). The issue with respect to this rejection is: Does the evidence of record support the Examiner’s conclusion that Chopra and Chen render obvious a “second defined volume” as required by claim 1? Findings of Fact 1. The Specification teaches “a communications interface adapted for receiving a first temperature measurement of a first volume of the subject and a second temperature measurement of a second volume of the subject” (Spec. 3:16-18). 4 Appeal 2016-003262 Application 13/501,571 2. The Specification teaches “the temperature in the first volume and the second volume may be measured using magnetic resonance thermometry” (Spec. 5:22—23). 3. Figure 5 of the Specification is reproduced below: FIG. 5 Fig. 5 illustrates the geometry of the prostate with the urethra 500 inside. An unfocused ultrasonic transceiver may be inserted into the urethra 500. Shown is the boundary 502 of the prostate. Point 504 represents a first volume within the boundary of the prostate 502 which would benefit from a heat treatment by an unfocused ultrasonic transceiver. The point labeled 506 represents a second volume which could represent a neurovascular bundle which could be damaged if it were heated above the third predetermined threshold by an unfocused ultrasonic transceiver. (Spec. 12:10-16). 4. Chopra teaches “using an ultrasound heating applicator to generate site-specific thermal lesions in diseased tissues which conform to a target volume and boundaries established by medical imaging, e.g., magnetic resonance imaging (MRI)” (Chopra 1 5). 5 Appeal 2016-003262 Application 13/501,571 5. Chopra teaches: Temperature measurements made with MRI techniques at or near the boundary of the target volume and/or the maximum temperature within the treatment volume are used to control the scan rate, power, and frequency of the heating applicator and/or of each element of the applicator, such that substantially the entire target volume reaches a predetermined therapeutic temperature or other thermal threshold. (Chopra 130). 6. Figure 2 of Chopra is reproduced below: FIG. 2 illustrates an example of conformal thermal therapy from a single directional ultrasound transducer, in the plane of rotation. The figure is a planar view with the page being in a plane perpendicular to the axial dimension of a heating applicator 204. . . . 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 6 Appeal 2016-003262 Application 13/501,571 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. (Chopra 148). 7. Figure 7 of Chopra is reproduced below: 2$ 20 40' 135 / ' / \ / ViV "y\\ 0-1*1) so 43-i ?as/' ... * •- N 4s - - A S3 : / A 1 / ■/ A : i .V \ I ■'* «'•'! -4 SO '• - \ - v ■ _ Vn. J)\ ^ \ • ■i \ ; VjvG i 22S " 270 $CJ 40 20- 33S / 0 4:$3 IM, A' 31S >v K 45A \\\ } -l .i0 \, 4iH 42S\. ''315 27Z. 702 *— Target Boundary 703 • 100% Ceil kill 704 A Q% Cell kill FIG. 7 illustrates four exemplary outcomes using the above- described computer simulations demonstrating the capability to perform conformal thermal therapy of the prostate gland using a directional ultrasound heating applicator. Each panel in the figure shows the target prostate boundary 702 derived from a clinical axial MR image of the prostate gland. The boundary 7 Appeal 2016-003262 Application 13/501,571 with solid circles 703 denotes the region that reached a thermal threshold of 55° C. during the treatment. This level of heating results in rapid and irreversible cell death through thermal coagulation, and is referred to as 100% cell kill 703 in the figure to indicate that substantially all of the diseased cells within this area would be killed by the thermal treatment. The boundary with the open triangles 704 represents the region that was exposed to at least 30 equivalent minutes at 43° C. of thermal isodose (T43=30 minutes). This is a measure of the combined time/temperature exposure standardized to a common temperature. This conservative level of thermal dose is typically considered to be the minimum thermal dose required to observe histological changes in prostate tissue, and represents the region outside which tissue would be unharmed by the heating. The contour is thus labeled as the 0% cell-kill boundary 704 in the figure to signify that substantially none of the cells in this region are killed by the thermal treatment. (Chopra 1 61). 8. Chen teaches the “output of the DC power supply 34 is provided to an input of a Color LCD Display and microcontroller 38, an input of an RF board 36, an input of a thermocouple and thermistor board 48, and an input of an ultrasound board 50” (Chen 121). Principles of Law “[DJuring examination proceedings, claims are given their broadest reasonable interpretation consistent with the [Specification.” In re Hyatt, 211 F.3d 1367, 1372 (Fed. Cir. 2000). “The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” KSRInt’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). “If aperson of 8 Appeal 2016-003262 Application 13/501,571 ordinary skill can implement a predictable variation, § 103 likely bars its patentability.” Mat417. Analysis We begin with claim interpretation because before a claim is properly interpreted, its scope cannot be compared to the prior art. In this case, the dispute centers over the phrase “second defined volume” in claim 1. While the Specification discusses temperature measurements of a “second volume” (FF 1), the Specification lacks a definition of the phrase “second defined volume” and exemplifies a “second volume” in Figure 5 as a point location outside the prostate boundary 502 (FF 3). Even if there were an embodiment showing a “second defined volume,” in the absence of a definition of the term “defined” it “is improper to ‘confm[e] the claims to th[e] embodiments’ found in the specification.” In re Trans Texas Holdings Corp., 498 F.3d 1290, 1299 (Fed. Cir. 2007) (alterations in original). Appellants “submit that it is unreasonable on the face of the claim language alone to completely read out the term defined. The Applicants have elected to recite a ‘second defined volume’ and not merely a second volume. The use of the term defined must be considered when interpreting the claim” (App. Br. 5). We do not find this argument persuasive because the term “defined” in this context is a term of degree depending upon subjective opinion in light of a Specification that identifies a second volume by a point outside a boundary (FF 3). Datamize teaches that the “scope of claim language cannot depend solely on the unrestrained, subjective opinion of a particular individual purportedly practicing the invention.” Datamize, LLC v. 9 Appeal 2016-003262 Application 13/501,571 Plumtree Software, Inc., 417 F.3d 1342, 1350 (Fed. Cir. 2005). Here, the phrase “second defined volume” would be subject to such subjectivity because no specific limits attach to the word “defined,” and we therefore interpret it broadly to encompass any volume that has boundaries of some sort. See In re Zletz, 893 F.2d 319, 321 (Fed. Cir. 1989) (“[Djuring patent prosecution when claims can be amended, ambiguities should be recognized, scope and breadth of language explored, and clarification imposed. ... An essential purpose of patent examination is to fashion claims that are precise, clear, correct, and unambiguous. Only in this way can uncertainties of claim scope be removed, as much as possible, during the administrative process.”). We adopt the Examiner’s findings of fact and reasoning regarding the scope and content of the prior art (Final Act. 3—9; FF 1—8) and agree that claim 1 is obvious over Chopra and Chen. We address Appellants’ arguments below. Appellants contend: [T]he application of the broadest reasonable interpretation is tempered with the guidance “consistent with the specification.” It appears the Examiner has attempted to address this concern by stating that “[ajpplicant never positively described in the specification the exact defined second volume.” (See 3/10/2014 Office Action, p. 15). This is simply incorrect. The application as filed positively describes a defined second volume with location boundaries, where the defined second volume is a specific anatomical feature that may be damaged if heated. An example of such a defined volume is a neurovascular bundle in the prostate, which is often located close to a targeted tumor region, that would negatively affect a patient’s potency if damaged. (App. Br. 6 (second alteration in original)). 10 Appeal 2016-003262 Application 13/501,571 We do not find this argument persuasive because Appellants identify no portion of the Specification that defines or limits the phrase “second defined volume” to specific anatomical features such as neurovascular bundles. See In re Self, 671 F.2d 1344, 1348 (CCPA 1982) (“[A]ppellanf s arguments fail from the outset because . . . they are not based on limitations appearing in the claims.”). Moreover, as already noted, without a definition of what constitutes a “second defined volume,” the term is based on the unrestrained, subjective opinion of individuals, not grounded in detailed limitations. Appellants contend, regarding Chopra, that the “region outside of boundary 704 is not a defined volume, but an open volume that encompasses anything within the imaging limits. The region does not represent a specific sensitive anatomical feature that must be kept below a specific temperature to avoid damage” (App. Br. 7). Appellants contend that Chopra never describes that these nearby tissue structures are a specifically defined volume for which temperature measurements are taken. Rather, the nearby tissue structures 207 are just structures that are not the target volume 201. Chopra never describes how one these nearby tissue structure are defined. Accordingly, the nearby tissue structures 207 of Chopra cannot be the “second defined volume” recited in claim 1. (App. Br. 8). We find these arguments unpersuasive. Whether we apply the Examiner’s broadest reasonable interpretation or Appellants’ narrower interpretation, Chopra clearly discloses a “second defined volume.” Figure 2 of Chopra discloses two volumes, target volume 201 and tissue structure 11 Appeal 2016-003262 Application 13/501,571 volume 207 (FF 6). Chopra shows tissue structure volume 207 as a specific, enclosed region with well-defined boundaries (FF 6). Consistent with the language and intent of claim 1, target volume 201 is subject to ultrasonic heating by the ultrasound transducer within the larger volume 202 and contains volume located between the transducer and the tissue structure volume 207 that is not subject to heating (FF 4—7). Thus, tissue volume 207 in Figure 2 of Chopra reasonably satisfies even Appellants’ narrow construction of “second defined volume” and both Figures 2 and 7 disclose regions of “second defined volume” that satisfy the Examiner’s broader reading of this phrase. We recognize, but find unpersuasive, Appellants’ contention that “the ‘second defined volume,’ could not be exceedingly large in size or located too closely to the ultrasound transducer because the first defined volume would not have room to fit between the ‘second defined volume’ and the ultrasound transducer” (Reply Br. 5). Neither claim 1 nor the Specification imposes any size or location limitations on the “second defined volume” other than that it falls within the imaging volume, which could encompass the entire body of the patient, and that it permit a first volume to be located between it and the transducer. Claim 1 imposes no requirement that these volumes are immediately adjacent one another or alternatively that they are separated by any particular distance, volume, or structures. In re Self, 671 F.2d at 1348. 12 Appeal 2016-003262 Application 13/501,571 Conclusion of Law The evidence of record supports the Examiner’s conclusion that Chopra and Chen render obvious a “second defined volume” as required by claim 1. B-E. 35 U.S.C. § 103(a) Appellants do not separately argue these obviousness rejections, instead relying upon their arguments to overcome Chopra and Chen (see App. Br. 9-10). The Examiner provides sound fact-based reasoning for combining Trachtenberg, Slayton, Carl, and Schneider with Chopra and Chen (see Final Act. 9—14). Having affirmed the obviousness rejection of claim 1 over Chopra and Chen for the reasons given above, we also find that the further combinations render the rejected claims obvious for the reasons given by the Examiner. SUMMARY In summary, we affirm the rejection of claim 1 under 35 U.S.C. § 103(a) as obvious over Chopra and Chen. Claims 3—6, 8, 9, 11, and 13—15 fall with claim 1. We affirm the rejection of claim 2 under 35 U.S.C. § 103(a) as obvious over Chopra, Chen, and Trachtenberg. We affirm the rejection of claim 7 under 35 U.S.C. § 103(a) as obvious over Chopra, Chen, and Slayton. We affirm the rejection of claim 10 under 35 U.S.C. § 103(a) as obvious over Chopra, Chen, and Carl. 13 Appeal 2016-003262 Application 13/501,571 We affirm the rejection of claim 12 under 35 U.S.C. § 103(a) as obvious over Chopra, Chen, Slayton, and Schneider. 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 14 Copy with citationCopy as parenthetical citation