Ex Parte Schultz et alDownload PDFPatent Trial and Appeal BoardJul 27, 201712741350 (P.T.A.B. Jul. 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. 12/741,350 08/04/2010 Peter Schultz 07038.0004-00000 6275 22852 7590 07/31/2017 FINNEGAN, HENDERSON, FARABOW, GARRETT & DUNNER LLP 901 NEW YORK AVENUE, NW WASHINGTON, DC 20001-4413 EXAMINER NGUYEN, HIEN NGOC ART UNIT PAPER NUMBER 3777 NOTIFICATION DATE DELIVERY MODE 07/31/2017 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): regional-desk @ finnegan. com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte PETER SCHULTZ, ARKADY AMOSOV, NATALIA IZVARINA, and SERGEY KRAVETZ1 Appeal 2016-003060 Application 12/741,350 Technology Center 3700 Before DONALD E. ADAMS, ERIC B. GRIMES, and JOHN E. SCHNEIDER, Administrative Patent Judges. GRIMES, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35U.S.C. § 134 involving claims to an apparatus for determining the concentration of an analyte in tissue, which have been rejected as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We reverse. STATEMENT OF THE CASE “The first step in diabetes care is to monitor the patient’s blood glucose level 24 hours a day.” (Spec. 13.) “Current methods of measuring blood glucose concentrations typically require the diabetic patient to 1 Appellants identify the Real Party in Interest as BIOSENSOR, INC. (Appeal Br. 4.) Appeal 2016-003060 Application 12/741,350 puncture a finger to collect a drop of blood” for analysis. (Id. 14.) The Specification discloses a method and apparatus that allow the tissue concentration of an analyte, such as glucose, to be determined non- invasively. (Id. 16-17.) Claims 1—28, 30-41, and 70-74 are on appeal. Claim 1 is illustrative and reads as follows (emphasis added): 1. An apparatus for determining a concentration of an analyte in tissue, comprising: at least one radiation source operative to emit a first radiation beam and at least one second radiation beam, the first radiation beam irradiating a testing area of tissue and cause a first scattering of radiation, and the at least one second radiation beam having a lower intensity than the first radiation beam and periodically irradiating the testing area of tissue causing periodic second scatterings of radiation; at least one detector comprising a first radiation detector and a second radiation detector, the first radiation detector and the second radiation detector being configured to detect the first scattering of radiation and the second scatterings of radiation and the radiation detectors convert the detected scatterings into electrical signals, wherein the first radiation detector and the second radiation detector are located at different distances from the testing area of tissue enabling a relative amplitude between the detected scatterings to be calculated and used as an offset; and a processor for determining the concentration of the analyte based on said electrical signals. Claims 70 and 74 are the only other independent claims. Claim 70 is directed to a probe head and requires a first radiation detector and a second radiation detector “configured to detect the first scattering of radiation and the second scatterings of radiation” and “located at different distances from the testing area of tissue.” (Appeal Br. 38—39.) Claim 74 is directed to an apparatus comprising first and second radiation sources that cause back- 2 Appeal 2016-003060 Application 12/741,350 scattering of radiation and “a first radiation detector and a second radiation detector for detecting the initial scattering and the periodic back-scatterings . . . wherein the first radiation detector and the second radiation detector are located at different distances from the portion of tissue.” {Id. at 40.) The claims stand rejected as follows: Claims 1—26, 30, 33, 35—37, 41, and 74 under 35 U.S.C. § 103(a) as obvious based on Rosencwaig,2 Chou,3 and Altshuler4 (Ans. 6); Claims 27, 31, 32, and 38 under 35 U.S.C. § 103(a) as obvious based on Rosencwaig, Chou, Altshuler, and Petrovsky5 (Ans. 12); Claim 34 under 35 U.S.C. § 103(a) as obvious based on Rosencwaig, Chou, Altshuler, and Colby6 (Ans. 13); Claims 39 and 40 under 35 U.S.C. § 103(a) as obvious based on Rosencwaig, Chou, Altshuler, and Marchitto7 (Ans. 14); Claims 28, 70, and 73 under 35 U.S.C. § 103(a) as obvious based on Rosencwaig, Acosta,8 Chou, and Altshuler (Ans. 2); Claim 71 under 35 U.S.C. § 103(a) as obvious based on Rosencwaig, Acosta, Chou, Altshuler, and McLachlan9 (Ans. 5); and Claim 72 under 35 U.S.C. § 103(a) as obvious based on Rosencwaig, Acosta, Chou, Altshuler, and Petrovsky (Ans. 6). 2 Rosencwaig, US 5,657,754, iss. Aug. 19, 1997. 3 Chou, US 5,941,821, iss. Aug. 24, 1999. 4 Altshuler, US 2007/0060819 Al, pub. Mar. 15, 2007. 5 Petrovsky, US 6,097,975, iss. Aug. 1, 2000. 6 Colby, US 2005/0277872 Al, pub. Dec. 15, 2005. 7 Marchitto, US 2002/0016533 Al, pub. Feb. 7, 2002. 8 Acosta, US 2005/0010090 Al, pub. Jan. 13, 2005. 9 McLachlan, US 4,573,761, iss. Mar. 4, 1986. 3 Appeal 2016-003060 Application 12/741,350 DISCUSSION All of the rejections on appeal rely on the combination of Rosencwaig, Altshuler, and Chou, and the same issue is dispositive for each of the rejections. We will therefore address them together. The Examiner finds that Rosencwaig discloses an apparatus meeting most of the limitations of claim 1 (Ans. 6—7) but “does not disclose a second radiation detector configured to detect the second scattering of radiation . . . wherein the first radiation detector and the second radiation detector are located at different distances from the testing area of tissue” {id. at 8). The Examiner finds that “Altshuler discloses the second radiation detector configured to detect radiation (see Fig. 6; element 11a).” {Id.) The Examiner finds that “Chou discloses wherein the first radiation detector and the second radiation detector are located at different distances from the testing area of tissue . . . (see Fig. 2 and col. 5, lines 1-51 . . .).” {Id.) The Examiner concludes that it would have been obvious to modify a second radiation detector configured to detect the second scattering of radiation and convert the detected scatterings into electrical signals; wherein the first radiation detector and the second radiation detector are located at different distances from the testing area of tissue ... as taught by Altshuler and Chou this improve [s] accuracy and quality of the signal (see Chou’s col. 5, lines 21-67). {Id. at 9.) Appellants argue that Chou’s “measuring cell 26 and reference cell 28 may be detectors, but reference cell 28 ... is not a radiation detector that detects scattering of radiation, as claimed, nor is it configured to be.” (Appeal Br. 19.) “In other words, the Examiner is asserting Chou teaches calculating relative amplitude between radiation scatterings detected by a 4 Appeal 2016-003060 Application 12/741,350 first radiation detector and a second radiation detector yet no second radiation detector is even disclosed or taught by Chou.'” (Id. at 20.) Appellants also argue that the combination of Rosencwaig, Chou, and Altschuler is based on hindsight. (Id. at 22—23.) We agree with Appellants that the Examiner has not made out a prima facie case of obviousness. Claim 1 requires a radiation source that emits first and second radiation beams, where the radiation beams cause first and second scatterings of radiation when they irradiate an area of tissue. Claim 1 also requires first and second radiation detectors that detect the first and second scatterings of radiation and are located at different distances from the testing area. In USPTO proceedings, claims are given their broadest reasonable interpretation consistent with the Specification. In re Hyatt, 211 F.3d 1367, 1372 (Fed. Cir. 2000). Here, Appellants’ Specification states that “[tjypical non-invasive optical methods utilize a beam of light to irradiate some selected part of the human body. . . . Fight that is transmitted through, reflected, or scattered out of the skin comprises information about the composition of the irradiated tissue.” (Spec. 1 8, emphasis added.) The Specification contrasts such optical methods with “laser photoacoustic spectroscopy,” such as described by Chou, in which acoustic energy is generated in the sample and “[t]he acoustic emission is detected” and used to measure glucose concentration. (Id. Tflf 10-11.) In describing the presently claimed apparatus, the Specification states that detector 132 may include separate scattered radiation detectors, as shown in FIG. 3, to separately receive first and second 5 Appeal 2016-003060 Application 12/741,350 scatterings of radiation Di and D2. Consistent with embodiments of the present invention, and may include optical receiving sensors, such as a photodiode, including a P-Intrinsic-N (PIN) photodiode, an avalanche photodiode, a photoelectrical multiplier, or a photoresistor. {Id. 137, emphasis added.) The Specification also states that “[f]irst and second radiation beams Bi and B2 will irradiate testing area 130, and a predetermined amount of radiation will be back scattered from the testing area. . . . Scatterings of radiation Di and D2 may then be detected by detector 132.” {Id. H 44^45, emphasis added.) Thus, the Specification’s description of both the prior art and the claimed apparatus are consistent with interpreting “radiation” to be limited to electromagnetic radiation such as light. A “radiation detector,” as recited in claim 1, therefore, must detect the scattering of electromagnetic radiation from an irradiated area of tissue. The Examiner cited Altshuler and Chou as disclosing the second radiation detector required by claim 1. (Ans. 8.) The Examiner cited element 1 la in Altshuler’s Figure 6 as a second radiation detector. {Id.) However, although the device shown in that figure includes two detectors, only one of them is described as detecting backscattered radiation from the irradiated skin. {See Altshuler 193: “A detector 10 . . . receives at least a portion of the radiation that is diffusely back-reflected (backscattered) from the illuminated skin.”); id. 194: “[T]he device 13 includes an optical sensor 11 having 11 a .. . which can determine whether the waveguide is in contact with the skin.”). Thus, Altshuler does not describe a device that includes two radiation detectors that each detect scatterings of radiation. 6 Appeal 2016-003060 Application 12/741,350 The Examiner also finds that, in Chou, the first radiation detector and the second radiation detector are located at different distances from the testing area of tissue . . . 26 and 28 are located at different distances from the target area 46; differential microphone basically have detectors at front and back to offset the noise; the detectors have to be at different distance in order to offset the noise; this is basic principle of differential microphone/noise-cancelation microphone. (Ans. 8-9.) Chou makes clear, however, that in its photoacoustic technique, the signal that is detected is an acoustic emission, not scattered radiation. Chou states that ‘“electromagnetic energy ... is utilized to irradiate the tissue. . . . Absorption of the light beam results in periodic heating of the tissue . . . and produces an acoustic emission in the measuring cell. This acoustic emission is detected with the differential microphone.” (Chou, Abstract.) This description is consistent with Chou’s description of elements 26 and 28, which the Examiner characterizes as radiation detectors. Chou states that “acoustic energy is detected by the probe 16 which includes a measuring cell 26, reference cell 28, window 30 and differential microphone 32.” (Id. at 4:57—60). As previously discussed, the broadest reasonable interpretation of the claim term “radiation detector” is an element that detects electromagnetic radiation. Chou’s elements 26 and 28 detect acoustic energy, not electromagnetic radiation. Thus, the Examiner has not shown that the cited references disclose or would have made obvious all of the elements of claim 1. The rejection of claim 1 as obvious based on Rosencwaig, Chou, and Altshuler is reversed. Claims 2—26, 30, 33, 35—37, and 41 depend from claim 1; the rejection of these claims is therefore reversed for the same 7 Appeal 2016-003060 Application 12/741,350 reason. Claim 74 also requires first and second radiation detectors; the rejection of this claim is also reversed for the reason discussed above. The Examiner rejected claims 27, 28, 31, 32, 34, 38-40, and 70-73 as obvious based on Rosencwaig, Chou, and Altshuler, combined with one or more of Petrovsky, Colby, Marchitto, Acosta, and McLachlan. Each of the additional rejections, however, rely on the Examiner’s finding that Chou discloses two radiation detectors at different distances from the tissue being irradiated. (Ans. 2—6, 12—14.) As discussed above, Chou’s detectors are not “radiation detectors,” under the broadest reasonable interpretation of that phrase in light of the Specification. The remaining rejections are therefore reversed for the same reason as the rejection based on Rosencwaig, Chou, and Altshuler. SUMMARY We reverse all of the rejections on appeal. REVERSED 8 Copy with citationCopy as parenthetical citation