Ex Parte Kaufman et alDownload PDFPatent Trial and Appeal BoardMar 25, 201613177892 (P.T.A.B. Mar. 25, 2016) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE FIRST NAMED INVENTOR 13/177,892 07/07/2011 Jonathan J. Kaufman 23399 7590 03/25/2016 REISING ETHINGTON P.C. PO BOX4390 TROY, MI 48099-4390 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. 8386.3010.001 7367 EXAMINER FERNANDEZ, KATHERINE L ART UNIT PAPER NUMBER 3768 MAILDATE DELIVERY MODE 03/25/2016 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 PATENT TRIAL AND APPEAL BOARD Ex parte JONATHAN J. KAUFMAN and GANGMING LUO Appeal2014-004327 Application 13/177,892 Technology Center 3700 Before DONALD E. ADAMS, JEFFREY N. FREDMAN, and JACQUELINE T. HARLOW, Administrative Patent Judges. PERCURIAM DECISION ON APPEAL This is an appeal 1 under 35 U.S.C. § 134 involving claims to an ultrasonic vertebral bone assessment apparatus and method. The Examiner rejected the claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b ). We affirm. 1 Appellants identify the Real Party in Interest as CyberLogic, Inc. (see App. Br. 1). Appeal2014-004327 Application 13/177,892 Statement of the Case Background Appellants' invention "relates generally to apparatus and method for non-invasively and quantitatively evaluating bone tissue in vivo" (Spec. i-f 2). The Claims Claims 1-10, 21, and 22 are on appeal. Independent claim 1 is representative and reads as follows (emphasis added): 1. A method of non-invasive and quantitative assessment of the status of a lumbar vertebral body in a living being for at least one of the quantities, bone-mineral density, bone mass, bone mineral content, bone strength, bone fracture risk, bone architecture and bone quality, comprising the steps of: acoustically coupling a first transducer and a second transducer to nearby skin on opposite sides of a torso of said living being; generating a first ultrasound signal and directing said first ultrasound signal from said first transducer to said second transducer through said torso, at least a first portion of said first ultrasound signal passing through said lumbar vertebral body, said second transducer generating a first output signal responsive to receipt of said first ultrasound signal; and, processing said first output signal to obtain an estimate of said at least one of the quantities, bone-mineral density, bone mass, bone mineral content, bone strength, bone fracture risk, bone architecture and bone quality. The Issue The Examiner rejected claims 1-10, 21, and 22 under 35 U.S.C. § 103(a) as obvious over Luo2 and Ishii3 (Final Act. 2---6). 2 Luo et al., US 2008/0194952 Al, published Aug. 14, 2008. 3 Ishii et al., US 5,902,240, issued May 11, 1999. 2 Appeal2014-004327 Application 13/177,892 The Examiner finds that Luo teaches "a method of non-invasive and quantitative assessment of the status of a bone in a bony member in a living being for at least one of the quantities, bone-mineral density, bone mass, bone mineral content, bone strength, bone fracture risk, bone architecture and bone quality" (Final Act. 2). The Examiner concludes that it would have been obvious to "have the method of Luo [] be applied to a lumbar vertebral body and thus have the first and second transducers be acoustically coupled to a torso of said living body, as taught by Ishii [] as a good site of ultrasonic measurements for bone assessment is a lumbar vertebra" (id. at 3; citing Ishii 10:52-57). The issue with respect to this rejection is: Does the evidence of record support the Examiner's conclusion that Luo and Ishii render the claims prima facie obvious? Findings of Fact 1. Luo teaches [a] method for the assessment of various properties of bone[]. The method includes applying a pair of ultrasound transducers to skin on opposite sides of a bony member and generating an ultrasound signal and directing the signal through the bony member to obtain a bone output signal. ... Two parameters are disclosed, namely two net time delay (NTD) parameters. The apparatus includes ... a means for establishing bone mineralization through use of both ultrasound and x-ray measurements. (Luo Abstract; see also Final Act. 2-3.) 2. Luo teaches that "the bone tissue evaluation and the osteoporosis diagnosis may be performed," and provides "more accurate and precise estimates of bone mass, bone density, bone geometry, bone quality, and bone strength" (Luo i-fi-f 14--15; see also Final Act. 2-3). 3 Appeal2014-004327 Application 13/177,892 3. Luo teaches that "[i]n the presently preferred embodiment ... the forearm 5 is measured and contains an ulna 21 and a radius 6" and that "[i]t should be further understood that [an] alternative embodiment ... may be used on any bone within a living body in which multi-directional ultrasound measurements can be obtained, not just the phalanges" (Luo i-f 23, 52; see also Ans. 2-3). 4. Luo teaches that [i]t should be appreciated that while this invention applies to bony members generally in a living being, certain bones which have shown to be well suited for ultrasound examination have been identified. They include, for example, the calcaneus (the heel bone), the phalanges (finger bones), the radius (wrist), and any of the long bones for cortical bone assessment (for example, the tibia and femur, particularly the proximal femur or hip). (Luo i-f 69; see also Ans. 2-3.) 5. Luo teaches that [ a]n additional embodiment [] is to operate a pair of transducers in both through transmission and pulse-echo mode; in this way, two sets of ultrasound parameters may be obtained, namely that set associated with the transmission measurements, and that set associated with the reflection measurements. It should be understood that these data sets may be further processed, using linear or nonlinear, univariate or multivariate regressions, to obtain one or more of the aforementioned bone properties. (Luo i-f 58; see also Ans. 4.) 6. Luo teaches that It is useful to provide some additional background as to the relationship between NTD and bone-mineral density. . . . For this it is useful to model the bony member as consisting solely of two layers, one bone layer of thickness db1, and another soft tissue layer of thickness ds1; the thickness, d, where d=db1 + ds1 is equal to the overall thickness of the bony member. It should 4 Appeal2014-004327 Application 13/177,892 be understood that the soft tissue layer includes not only the overlying soft tissues but all the soft tissues located in the path of an ultrasound wave, for example, including the soft tissues within the marrow spaces of any trabecular bone that may be part of the bony member. It should further be understood that the bone tissue layer includes all of the bone located in the path of an ultrasound wave, and that it has been effectively compressed into a single layer. In this model, then, the time delay of the bone-oriented signal is 'Cb, where 1;b= 'Cb1 + 'Cs1, and 'Cb1 is the time for propagation through the pure bone layer, and 'Csi is the time for propagation through the pure soft tissue layer. The expression can then be written, using 'Cb1=dbi/Vb1, and 'Cs1= dsi/Vs1 where Vb1 and Vs1 are the speed of propagation of ultrasound through bone and soft tissue, respectively, as d/vs1- 1;b=db1 (vb1 - Vs1)/( Vb1 ·vs1). In this expression, db1 is the parameter of interest, namely (directly proportional to) the total bone mass or bone- mineral density (BMD) of the bony member and the other parameters, namely Vb1 and Vs1 can, as the present inventors have discovered, be treated as constants. Therefore, recognizing that d/vs1- 'Cb is the net time delay, it should then be appreciated that NTD is proportional to the BMD. (Luo if 50). 7. Ishii teaches "[a Jn osteoporosis diagnosis [apparatus] provided with a two-dimensional ultrasonic transducer array" in which "[t]he ultrasonic transducer array (3) is applied to the skin covering a predetermined bone of a subject, and ... sequentially emit[ s] a predetermined number of ultrasonic pulses through the skin while receiving echoes from the bone" (Ishii Abstract; see also Final Act. 3). 8. Ishii teaches "an ultrasonic pulse-echo type osteoporosis diagnosing apparatus and method, which diagnoses osteoporosis by emitting ultrasonic pulses towards a certain bone of an examinee and detecting the echoes from the bone" (Ishii 1 :5-9; see also Final Act. 3). 5 Appeal2014-004327 Application 13/177,892 9. Ishii teaches that "a bone Mb is selected as the site of measurement which, although not necessarily very flat, has a sufficiently large radius of curvature relative to the wavelength of the ultrasonic pulse" and that "[g]ood sites of measurement include a lumbar vertebra, humerus, tibia, calcaneus or neck of the femur" (Ishii 10:52-57; see also Final Act. 3, Ans. 3). Principles of Law "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456 (CCPA 1955). "Only if the 'results of optimizing a variable' are 'unexpectedly good' can a patent be obtained for the claimed critical range. In re Antonie, 559 F.2d 618, 620 ... (CCPA 1977)." In re Geisler, 116 F.3d 1465, 1469 (Fed. Cir. 1997). Analysis We adopt the Examiner's findings of fact and reasoning regarding the scope and content of the prior art (Final Act. 2-6; FF 1-9) and agree that the claims are obvious over Luo and Ishii. We address Appellants' arguments below. Appellants contend that "[i]n contrast to the claimed invention and Luo[], Ishii[] disclose[s] an ultrasound assessment method based on pulse- echo ultrasound (i.e., ultrasound where the same transducer is used to send and receive the reflected ultrasound wave)" (App. Br. 3). Appellants argue that [b ]ecause the stated benefit of using the lumbar vertebra is tied specifically to the use of pulse-echo ultrasound techniques, one of ordinary skill in the art would not have been led to combine 6 Appeal2014-004327 Application 13/177,892 this teaching with the through-transmission ultrasound method disclosed in Luo[]. [Appellants] further note[] in this regard that Ishii [] specifically criticize[ s] through transmission diagnostic methods as lacking in any theoretical basis thereby making it even more unlikely that one of ordinary skill in the art would combine the teachings of Luo [] and Ishii (Id. at 3--4; citing Ishii 1 :35-2:2.) Appellants also argue that Ishii criticizes reliance on attenuation in through transmission testing due to missing established theoretic basis (Reply Br. 2-3; citing Ishii 1 :35--44). Appellants then contend that Ishii relies on a signal that does not pass through the cortical shell of the bone while Appellants employ a signal that does (App. Br. 4). We are not persuaded. While Ishii describes problems associated with the assumption that the speed of sound is proportional to bone density when diagnosing osteoporosis, the later filed and later published Luo4 recognizes these concerns but nonetheless applies through transmission and establishes a theoretical basis for that through transmission measurements "may be used on any bone within a living body in which multi-directional ultrasound measurements can be obtained" (FF 1, 3, 6, see also Ans. 5 (citing Ishii i-fi-f 19-20, Luo i-fi-19-12)). The theoretical basis to which Appellants refer relates to Ishii' s discussion of prior art that pre-dates Ishii, and does not apply to the later invented, filed, and published Luo reference. Further, as the Examiner points out, Luo teaches using through transmission, in addition to pulse-echo, to measure and diagnose (Ans. 4; FF 4, 5). See W.L. Gore &Assoc., Inc. v. Garlock, Inc., 721F.2d1540, 1550 4 We note that Luo's publication date is August 14, 2008 while Ishii's issuance date is May 11, 1999, or at least 9 years before Luo' s date. 7 Appeal2014-004327 Application 13/177,892 (Fed. Cir. 1983) (A prior art reference must be considered in its entirety, i.e., as a whole, including portions that would lead away from the claimed invention). Thus, to the extent that Ishii criticizes the use of through transmission as a mode of analysis, the later published Luo demonstrates the theoretical basis Ishii found lacking and provides detailed information on calculating information regarding bone density and other parameters using through transmission techniques (FF 6). In addition, Appellants do not establish an evidentiary basis on this record to support the conclusion that the lumbar vertebra is tied to pulse- echo such that through transmission cannot be used. See In re Geisler, 116 F.3d 1465, 1470 (Fed. Cir. 1997) ("[A]ttomey argument [is] not the kind of factual evidence that is required to rebut a prima facie case of obviousness"). Like our appellate reviewing court, "[ w ]e will not read into a reference a teaching away from a process where no such language exists." DyStar Textilfarben GmbH & Co. Deutschland KG v. CH Patrick Co., 464 F.3d 1356, 1364 (Fed. Cir. 2006). Appellants contend that Ishii indicates that only pulse-echo is appropriate for use with vertebral bones because the site is relatively flat (App. Br. 4--5 (citing Ishii 10:52-57); see also Reply Br. 2). We do not find this argument persuasive. As Examiner points out both Ishii and Luo teach measuring other bones, beside the vertebral bones, such as the tibia, calcaneus and femur (Ans. 2-3; FF 3--4, 8). Ishii merely indicates that these bones are "good sites of measurements" and therefore, does not restrict measurement to these bones only (Ans. 5---6; FF 8). Therefore, Ishii does not suggest only the vertebral bones can be used for testing. Appellants do not establish any evidence on this record to support 8 Appeal2014-004327 Application 13/177,892 the conclusion that only vertebral bones are suited for through transmission measurement, and Luo expressly suggests that the method "may be used on any bone within a living body in which multi-directional ultrasound measurements can be obtained" (FF 3). See In re Geisler, 116 F.3d at 1470. See also In re Aller, 220 F.2d at 456 and In re Geisler, 116 F.3d at 1469. Appellants contend that Ishii does not teach through transmission of vertebral bones (Reply Br. 2). This argument is not persuasive because Appellants fail to account for Luo' s contribution to the combination of Luo and Ishii, as Luo teaches through transmission (FF 1, 5). "Non-obviousness cannot be established by attacking references individually where the rejection is based upon the teachings of a combination of references []. [The reference] must be read, not in isolation, but for what it fairly teaches in combination with the prior art as a whole. " In re Merck & Co., 800 F .2d 1091, 1097 (Fed. Cir. 1986). SUMMARY In summary, we affirm the rejection of claim 1 under 35 U.S.C. § 103(a) as obvious over Luo and Ishii. Claims 2-10, 21, and 22 fall with claim 1. 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 9 Copy with citationCopy as parenthetical citation