11534095 (B.P.A.I. Jan. 31, 2011)

Ex Parte Tearney et al

Board of Patent Appeals and InterferencesJan 31, 2011

11534095 (B.P.A.I. Jan. 31, 2011)

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. 11/534,095 09/21/2006 Guillermo J. TEARNEY 186599/US/3 - 475387-0028 5394 30873 7590 01/31/2011 DORSEY & WHITNEY LLP INTELLECTUAL PROPERTY DEPARTMENT 250 PARK AVENUE NEW YORK, NY 10177 EXAMINER SMITH, RUTH S ART UNIT PAPER NUMBER 3737 MAIL DATE DELIVERY MODE 01/31/2011 PAPER 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. PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE BOARD OF PATENT APPEALS AND INTERFERENCES ____________ Ex parte GUILLERMO J. TEARNEY and BRETT E. BOUMA ____________ Appeal 2009-009547 Application 11/534,095 Technology Center 3700 ____________ Before WILLIAM F. PATE III, STEVEN D.A. McCARTHY and MICHAEL W. O’NEILL, Administrative Patent Judges. McCARTHY, Administrative Patent Judge. DECISION ON APPEAL1 1 The two-month time period for filing an appeal or commencing a civil action, as recited in 37 C.F.R. § 1.304, or for filing a request for rehearing, as recited in 37 C.F.R. § 41.52, begins to run from the “MAIL DATE” (paper delivery mode) or the “NOTIFICATION DATE” (electronic delivery mode) shown on the PTOL-90A cover letter attached to this decision. Appeal 2009-009547 Application 11/534,095 2 The Appellants appeal under 35 U.S.C. § 134 from the Examiner’s 1 decision rejecting claims 62-77 and 81. At least claim 62, corresponding to 2 claim 1 of parent US Application 10/016,244, is twice rejected. 3 The Examiner rejects claims 62-77 and 81 under 35 U.S.C. § 103(a) 4 as being unpatentable over Zimnyakov (Speckle-Contrast Monitoring of 5 Tissue Thermal Modification, 41 APPLIED OPTICS, pp. 5989-5996 (Optical 6 Soc’y of Am., Oct. 2002)), Guzelsu (US 6,324,419 B1, issued Nov. 27, 7 2001) and Lemelson (US 5,735,276, issued Apr. 7, 1998). The Examiner 8 has withdrawn a nonstatutory obviousness-type double patenting rejection of 9 claims 62-84 in view of a terminal disclaimer filed Jun. 13, 2008. The 10 Examiner has objected to claims 78-80 and 82-84. Claims 62, 74, 77 and 81 11 are independent claims. 12 We REVERSE. 13 Claim 62 is illustrative of the claims on appeal: 14 62. A method of analyzing tissue, comprising: 15 illuminating a tissue with at least one of a 16 coherent light or a partially coherent light; 17 receiving a further light reflected from the 18 tissue and forming a series of speckle patterns; and 19 analyzing changes in the speckle patterns at 20 time intervals sufficient to measure changes caused 21 by a microscopic motion of objects within the 22 tissue, wherein the tissue is at least one of in vivo 23 or an internal tissue. 24 (Emphasis added.) 25 Claim 74 recites a method of analyzing tissue structure. The method 26 of claim 74 includes a step of “assessing the tissue structure by analyzing 27 spatial characteristics of the speckle pattern data to determine at least one of 28 Appeal 2009-009547 Application 11/534,095 3 structural characteristics or biomechanical characteristics of the tissue 1 structure, wherein the tissue structure is at least one of in vivo or an internal 2 tissue structure.” Claims 77 and 81 recite apparatuses having 3 “arrangements” configured to perform functions corresponding to steps of 4 method claims 62 and 74, respectively. 5 Zimnyakov describes speckle-contrast monitoring of tissue thermal 6 modification whereby ex vivo porcine cartilage samples are illuminated via a 7 laser beam and speckle-modulated images were received via a CCD camera 8 with a zoom lens. (Zimnyakov, p. 5990, col. 1, ll. 47-61). 9 The Specification at page 5, line 25 formally defines “tissue” as “any 10 biological structure in or on a body.” Zimnyakov’s ex vivo porcine cartilage 11 is not a tissue because it is not a biological structure in or on a body. 12 The Examiner looks to Guzelsu and Lemelson to teach the use of the 13 tissue being at least one of in vivo or an internal tissue. (Ans. 4-5). 14 “Rejections on obviousness grounds cannot be sustained by mere conclusory 15 statements; instead, there must be some articulated reasoning with some 16 rational underpinning to support the legal conclusion of obviousness.” In re 17 Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006), cited with approval in KSR Int’l 18 Co. v. Teleflex Inc., 550 U.S. 398, 417-18 (2007). The Appellants correctly 19 contend that Zimnyakov does not describe, and Guzelsu and Lemelson do 20 not teach, “the analysis of changes in the speckle patterns at time intervals 21 sufficient to measure changes caused by microscopic motion of objects 22 within the tissue, wherein the tissue structure is at least one of in vivo or an 23 internal tissue.” (App. Br. 11 and 12-14) (emphasis omitted). 24 First the Examiner concludes “[i]t is well known in the art to first 25 perform a method in-vitro in an experimental set-up prior to in-vivo testing.” 26 Appeal 2009-009547 Application 11/534,095 4 (Ans. 4). The Examiner further concludes “use of optical diagnostic 1 methods in-vivo which result from first performing the test in vitro is old 2 and well known.” (Id.) Assuming for the purposes of this appeal only that 3 the above statements are correct, the statements do not provide an articulated 4 reasoning with some rational underpinning sufficient to support the legal 5 conclusion of obviousness. The Examiner has not provided evidence or 6 technical reasoning to show that the ex vivo and in vivo environments are so 7 similar that that similarity alone might have provided one of ordinary skill in 8 the art reason to apply an improvement to an ex vivo technique in an in vivo 9 environment. 10 More specifically, the teachings of Zimnyakov do not support findings 11 that one of ordinary skill in the art would have had sufficient skill to apply 12 Zimnyakov’s technique to an in vivo environment or that the pertinent art is 13 sufficiently predictable to provide a reasonable expectation of success to 14 such an application. (See App. Br. 15; Reply Br. 5). Zimnyakov sheds light 15 on these points on page 5995, “[t]he important question is adaptation of the 16 technique discussed to the case of backscattered light detection that can be 17 used to develop a real-time monitoring system for a laser reshaping in 18 clinical conditions . . . but some problems may appear in this case.” 19 Zimnyakov suggests, but does not state with any degree of certainty, how to 20 address the problem of bulk scattering. 21 The Examiner uses Guzelsu, as extrinsic evidence or a teaching that 22 one of ordinary skill can transition an ex vivo measurement including 23 speckle pattern analysis to an in vivo or internal tissue measurement. The 24 Examiner’s analysis does not address the fact that Guzelsu specifically 25 describes laser speckle analysis “will not work for skin or other soft tissues 26 Appeal 2009-009547 Application 11/534,095 5 because of the lack of fine natural grating lines for laser diffraction,” 1 however. (See Guzelsu, Abstract, and col. 2, l. 64 – col. 3. l. 8). As such, 2 Guzelsu disparages and thereby “teaches away from” using laser speckle 3 analysis with skin or other soft tissues. 4 Lemelson does not discuss speckle pattern analysis. Nonetheless, the 5 Examiner reasons in the Examiner’s Answer on pages 4 through 5: 6 Furthermore, it is known to provide optical testing 7 to both skin and internal tissues as seen in 8 Lemelson. It would have been obvious to one 9 skilled in the art to have carried out the method of 10 Zimnyakov et al in-vivo as is a well known 11 expedient in the art of optical tissue diagnosis and 12 to either monitor the skin or internal tissue such as 13 taught by Lemelson. 14 Nothing in Lemelson teaches applying ex vivo techniques to in vivo 15 environments, however. The Examiner’s emphasis on Lemelson’s use of a 16 catheter or endoscope to monitor tissue (Ans. 5), does address the lack of 17 reasoned analysis of the transition. 18 In regards to the remaining independent claims 74, 77 and 81 the 19 combined teachings of Zimnyakov, Guzelsu and Lemelson fail to provide 20 either a step of “assessing the tissue structure by analyzing spatial 21 characteristics of the speckle pattern data to determine at least one of 22 structural characteristics or biomechanical characteristics of the tissue 23 structure, wherein the tissue structure is at least one of in vivo or an internal 24 tissue structure” or apparatus having “arrangements” configured to perform 25 functions corresponding to steps of method claims 62 and 74, respectively. 26 The Examiner’s conclusion of obviousness lacks rational 27 underpinning. We do not sustain the rejection of claims 62-77 and 81 under 28 Appeal 2009-009547 Application 11/534,095 6 35 U.S.C. § 103(a) as being unpatentable over Zimnyakov, Guzelsu and 1 Lemelson. 2 3 DECISION 4 We REVERSE the Examiner’s decision rejecting claims 62-77 and 5 81. 6 7 REVERSED 8 9 10 11 Klh 12 13 14 15 DORSEY & WHITNEY LLP 16 INTELLECTUAL PROPERTY DEPARTMENT 17 250 PARK AVENUE 18 NEW YORK NY 10177 19