Ex Parte Carp et alDownload PDFPatent Trial and Appeal BoardNov 15, 201711766444 (P.T.A.B. Nov. 15, 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. 11/766,444 06/21/2007 Stefan A. Carp 125141.00176 9377 26710 7590 QUARLES & BRADY LLP Attn: IP Docket 411 E. WISCONSIN AVENUE SUITE 2350 MILWAUKEE, WI 53202-4426 EXAMINER GUPTA, VANI ART UNIT PAPER NUMBER 3786 NOTIFICATION DATE DELIVERY MODE 11/17/2017 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): pat-dept@quarles.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte STEFAN A. CARP and DAVID ALAN BOAS1 Appeal 2016-005325 Application 11/766,444 Technology Center 3700 Before FRANCISCO C. PRATS, ULRIKE W. JENKS, and DEVON ZASTROW NEWMAN, Administrative Patent Judges. JENKS, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134(a) involving claims directed to a method and an apparatus for determining tissue status. The Examiner rejects the claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM-IN-PART. 1 According to Appellants, the real party in interest is “The General Hospital Corporation.” Br. 1. Appeal 2016-005325 Application 11/766,444 According to the Specification2 “cancerous tissue consumes more oxygen, [and] the magnitude of the local reduction in the oxygenated hemoglobin concentration is expected to be higher when cancerous tissue is present than it would be if only normal breast tissue were present.” Spec. 137. Claims 33—61 are on appeal, and can be found in the Claims Appendix of the Appeal Brief. Claims 33 and 49 are representative of the claims on appeal, and read as follows: 33. A method for producing a report indicative of a status of a tissue, the method comprising: a) varying a compression state of a tissue; b) acquiring measurement data from the tissue using a medical imaging system while the compression state of the tissue is varied; c) generating an estimate of at least one of oxygen saturation and hemoglobin concentration in the tissue from the acquired measurement data; d) computing at least one of volumetric blood flow and volumetric oxygen consumption in the tissue using a metabolic model and the generated estimate of at least one of oxygen saturation and hemoglobin concentration in the tissue; and e) generating a report of the computed at least one of volumetric blood flow and volumetric oxygen consumption. 49. A device for producing a report indicative of a status of a tissue, the device comprising: a force applicator configured to produce a series of selected compression states in a tissue; an imaging apparatus configured to acquire measurement data from the tissue; and a processor configured to compute at least one of volumetric blood flow and volumetric oxygen consumption in 2 For reference convenience, when citing to the Specification we will refer to the published application US 2008/0004531 Al, published Jan. 3, 2008. 2 Appeal 2016-005325 Application 11/766,444 the tissue during the series of selected compression states and to generate report on a pathological status of the tissue using a metabolic model. Appellants request review of the following rejections:3 I claims 33—38, 40-43, 45, and 46 under 35 U.S.C. § 103(a) as unpatentable over Jeon,4 Yodh,5 and Abrams6 (Br. 5—17); and II. claims 44, 47, 49—54, and 56—61 under 35 U.S.C. § 103(a) as unpatentable over Jeon, Yodh, Abrams, and Cabib7 (Br. 17—21). I. Obviousness over Jeon, Yodh, and Abrams The Examiner finds that Jeon teaches the claimed elements of using a medical device to (a) vary compression state of a tissue, (b) acquire measurement data, and (c) estimate hemoglobin concertation in the tissue. See Ans. 2—3. The Examiner acknowledges that Jeon does not suggest specifically computing at least one of volumetric blood flow and volumetric oxygen consumption in the tissue using a metabolic model and the generated estimate of at least one of oxygen saturation and hemoglobin 3 We note that the Final Office Action (mailed Sept. 18, 2014 (“Final Act.”)) and Answer included two additional rejections that Appellants do not specifically address in their Brief. Claim 39 stands rejected under 35 U.S.C. § 103(a) as unpatentable over Jeon, Yodh, Abrams, and Benaron (US 2007/0027371 Al, published Feb. 1, 2007) (Final Act. 7—8; Ans. 7—8); and claims 48 and 55 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Jeon, Yodh, Abrams, and Chance (US 2005/0197583 Al, published Sept. 8, 2005) (Final Act. 11—12; Ans. 12). Because Appellants do not present arguments with respect to these rejections, we affirm these rejections for the reasons set out by the Examiner in the Final Action and Answer. 4 Jeon et al., US 2003/0009090 Al, published Jan. 9, 2003 (“Jeon”). 5 Yodh et al., US 2006/0063995 Al, published Mar. 23, 2006 (“Yodh”). 6 Abrams et al., US 4,671,295, issued June 9, 1987 (“Abrams”). 7 Cabib et al., US 2001/0033364 Al, published Oct., 25, 2001 (“Cabib”). 3 Appeal 2016-005325 Application 11/766,444 concentration in the tissue; and generating a report of the computed at least one of volumetric blood flow and volumetric oxygen consumption. Id. at 3. The Examiner relies on Yodh’s metabolic modeling for computing oxygen consumption, specifically, “modeling tissue metabolic rate of oxygen consumption with calculations that combine the blood flow data, total hemoglobin concentration (THC), oxygen consumption or metabolism, and oxygen saturation data.” See Id. at 3 & 15. The Examiner finds the combination of Jeon and Yodh “does not suggest specifically that volumetric blood flow is being considered and/or needs to be considered.” Id. at 4. The Examiner relies on Abrams’ teaching of “determining ‘volumetric rate of blood flow’ of blood flowing in a blood vessel.” Id. The Examiner concludes that it would have been obvious to one ordinary skill in the art to modify the oxygen saturation and hemoglobin concentration measurements in compressed tissue teachings of Jeon with the modeling tissue metabolic rate of oxygen consumption with calculations that combine the blood flow data and oxygen saturation data of Yodh so that one may obtain valuable information about [how] volumetric tissue blood flow responds to energy demands. Id. at 5. Appellants contend that Abrams is non-analogous art, and that modifying to Jeon would change the principle of operation of that reference. Specifically, Appellants argue that “[modifying Jeon in accordance with the teachings of Abrams would require a substantial redesign of the elements shown in Jeon.” Br. 10. The issue is: Does the preponderance of evidence of record support the Examiner’s conclusion that the combination of references teaches a method of computing volumetric oxygen consumption as claimed? 4 Appeal 2016-005325 Application 11/766,444 Findings of Fact We adopt the Examiner’s findings of fact and reasoning regarding the scope and content of the prior art. See Answer and Final Action. For emphasis only we highlight the following: FF1. Jeon teaches an apparatus and a method of monitoring hemoglobin concentration and oxygen saturation at a predetermined body site, for example a blood vessel in the finger. See Jeon Abstract and 134; see Ans. 3. Figure 2 of Jeon, reproduced below, shows the components of the hemoglobin monitoring system. The apparatus of FIG. 2 includes a light radiation unit 40, a photodetector unit 42, a variation calculation unit 68, a ratio calculation unit 70, and a concentration calculation unit 72. The apparatus may further include correction members 44 and 46, a compression unit 60, an amplifier 62, a low-pass filter (FPF) 64, an analog-to- 5 Appeal 2016-005325 Application 11/766,444 digital converter (ADC) 66, an oxygen saturation calculation unit 74, and a display unit 76. Jeon 124; see Ans. 2. FF2. Jeon teaches that the apparatus may further include a compression unit 60 for compressing the predetermined site 50. Here, the compression unit 60 externally receives, through an input port IN2, information on a variable pressure to be applied to the predetermined site 50, analy[z]es the received information, and compresses the predetermined site 50 by the pressure determined according to the result of information analysis. As pressure from the compression unit 60 is applied to the predetermined site 50, the light radiation unit 40 sequentially radiates incident light beams onto the predetermined site 50. Jeon 178; see Ans. 2. FF3. Jeon teaches that “the concentration calculation unit 72 calculates hemoglobin concentration (Cm) in blood using at least one ratio R12 of light attenuation variation between two wavelengths input from the ratio calculation unit 70, and outputs the calculated hemoglobin concentration (CHb).” Jeon 147. “Unlike in conventional methods, water absorbance is not considered in the measurement of the hemoglobin concentration and oxygen saturation according to . . . [Jeon’s method] so that the hemoglobin concentration and oxygen saturation may be accurately measured without being influenced by variation in body liquid volume.” Jeon 196; see Ans. 3. FF4. Yodh teaches measuring “hemoglobin concentration and blood oxygen saturation from diffuse reflection spectroscopy (DRS) measurements, and blood flow from diffuse correlation spectroscopy (DCS) measurements.” Yodh 131; see Ans. 3. 6 Appeal 2016-005325 Application 11/766,444 FF5. Yodh teaches: Tissue metabolic rate of oxygen consumption (TMRO2) may be modeled. ... In particular, TMRO2 may be calculated by combining the blood flow data and oxygen saturation data. In steady-state, TMRO2 depends on the difference in oxygen concentration across the vasculature (i.e., arteriole minus venous) multiplied by the blood flow rate, or TMR02=(0EF)x(BF)x([02 ]a), an equation sometimes referred to as Fick’s Law, where [C>2]a is the arterial oxygen concentration, OEF is the oxygen extraction fraction defined as ([C>2]a- [O2]v)/([02]a), and where subscripts v and a denote venous and arterial sides, and where BF is tissue blood flow. This is a general equation typically used in analysis of oxygen metabolism problems, particularly those associated with activation in brain and muscle. It could be replaced with any other adequate model. Yodh 138; see Ans. 4. FF6. Abrams teaches a method of measuring volumetric blood flow. “[U]ltrasound signals are generated and the Doppler shift is measured for velocity calculation and data for calculating the diameter of the artery is also collected. These data are used to determine the volumetric rate of blood flow.” Abrams 7:15—19; see Ans. 4. Principle of Law “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). “[W]henthe question is whether a patent claiming the combination of elements of prior art is obvious,” the answer depends on “whether the improvement is more than the predictable use of prior art elements according to their established functions.” Id. at All. 7 Appeal 2016-005325 Application 11/766,444 Analysis Claim 33—38, 40—42, and 46 Appellants contend that Abrams is not analogous art because it is not in the same field of endeavor. Br. 6—7. We are not persuaded by Appellants contention that Abrams is not analogous art. Two criteria have evolved for determining whether prior art is analogous: (1) whether the art is from the same field of endeavor, regardless of the problem addressed, and (2) if the reference is not within the field of the inventor’s endeavor, whether the reference still is reasonably pertinent to the particular problem with which the inventor is involved. In re Clay, 966 F.2d 656, 658-59 (Fed. Cir. 1992). As explained by the Examiner, claim 33 is broadly directed to acquiring measurement data from a medical imaging system. Abrams teaches a medical imaging system that is used to determine blood flow in an artery by applying ultrasound and measuring Doppler shift to determine blood flow in a vessel. FF6. Jeon also teaches a medical imaging system that applies light beams to a “predetermined body site, for example a blood vessel in the finger.” FF1. Jeon teaches that, based on the light scattering and light absorption, one is able to determine hemoglobin concentration and oxygen saturation. See FF1—FF3. Thus, both Abrams and Jeon teach taking measurements using medical imaging systems even though each type of system differs in the data gathered. Yodh, similarly, teaches using a device for measuring “blood oxygenation and flow in different layers the investigated tissue is layered (e.g., skin, adipose tissue and muscle or skull and cortex).” Yodh 136; FF4 & FF5. The evidence, therefore, suggests that the art is from the same field of endeavor, namely medical measurements 8 Appeal 2016-005325 Application 11/766,444 and more specifically measuring blood oxygen levels in vessel, blood oxygenation and blood flow in a tissue, or blood flow in a vessel. Even if the measurement data collected in each reference is different, each is reasonably pertinent to determining patient health based on blood properties. Appellants have not provided objective evidence to support their contention that the field of endeavor of the references Jeon, and Yodh is sufficiently different from that of Abrams to preclude combining the teachings of the references in an obviousness analysis. Accordingly, we agree with the Examiner that the evidence suggests that the references are reasonably considered to be analogous art. Appellants contend that “[t]he claimed invention is concerned with providing a non-invasive tool for the detection of cancers, such as breast cancer” and Abrams is not pertinent to that problem. Br. 7. We are not persuaded. In this case, the claimed invention encompasses the fields of blood health and blood property measurements. Appellants have defined the field too narrowly, restricting the field to the narrower purpose for which the measurements are intended to be used, in other words, the application in detection of cancers. We note that detection of cancer is not a limitation appearing in the claim. See Br. 7. As stated by our reviewing court in In re Hiniker Co., 150 F.3d 1362, 1369 (Fed. Cir. 1998), “the name of the game is the claim.” It is well established that limitations not appearing in the claims cannot be relied upon for patentability. In re Self, 671 F.2d 1344, 1348 (CCPA 1982). Claim 33 is directed to tissue but is not limited to a particular type of tissue, nor does the claim require that the data acquired by the medical imaging system claimed 9 Appeal 2016-005325 Application 11/766,444 is used to determine any type of illness. Thus, arguments directed to limitations not appearing in the claim are not persuasive. Appellants contend that the proposed combination is not obvious because it would render Jeon inoperable. Br. 9—11. According to Appellants, “volumetric blood flow is a quantitative measurement of the rate at which blood flows through a unit volume of tissue. . . . Similarly, volumetric oxygen consumption is [a] quantitative measurement of the rate at which oxygen is used by tissues ver unit volume of tissue. . . . These are quantitative measurements of physical properties of a tissue and are measurements defined by physical dimensions.” Id. at 10. Specifically, Appellants contend that Jeon looks at light being passed through at a particular point and bases calculations on that information, while Abrams uses Doppler ultrasound technique to determine flow velocity at a particular point from which volume can be calculated. See id. Because of these different approaches, Appellants contend that their combination “would require a substantial redesign of the elements shown in Jeon.” Id., see also id. at 11 (“the processing taught by Jeon provides no teaching or suggestion as to how optical measurements could be correlated with the ultrasound measurements of Abrams”). We are not persuaded by Appellants’ contention that the combination as proposed by the Examiner requires functional alteration of the mechanism used by Jeon’s apparatus. Instead the Examiner’s proposed combination adds a Doppler ultrasound feature for the determination of volumetric blood flow to Jeon’s apparatus. See Ans. 15. In other words, the Examiner concludes that it would have been obvious to include both types of detectors in a single device. The Examiner explains that “Abrams is simply used to 10 Appeal 2016-005325 Application 11/766,444 cover the volumetric blood flow limitation [of claim 33], which is a given with ultrasound imaging” and Jeon teaches “a method for noninvasively accurately monitoring hemoglobin concentration and oxygen saturation by considering light scattering by red blood cells.” Id. at 13—14. The Examiner finds Yodh measures “blood flow, oxy- and/deoxy hemoglobins, and oxygenation, scattering and hemodynamic characteristics in tissue . . . using diffuse optical spectroscopy and imaging, and diffuse-correlation methods.” Id. at 14. The Examiner concludes that, based on the combination, it would have been obvious to combine different sensors into one apparatus in order “to measure multiple blood properties [at the same time] - to include volumetric blood flow or volumetric oxygen consumption, and blood flow parameters.” Id. at 15, citing Furman8 in support of using multiple sensors in one apparatus. We find no error with the Examiner’s conclusion that the Doppler components of Abrams’ device can be incorporated into Jeon’s device without rendering Jeon’s device inoperable as argued by Appellants. We conclude that the evidence cited by the Examiner supports a prima facie case of obviousness with respect to claim 33, and Appellants have not provided sufficient rebuttal evidence or evidence of secondary considerations that outweigh the evidence supporting the Examiner’s conclusion of obviousness. As Appellants do not argue the claims separately, claims 34, 37, 38, 41, and 42 fall with claim 33. 37 C.F.R. §41.37 (c)(l)(iv). 8 Furman et al., US 8,298,148 B2, issued Oct. 30, 2012. 11 Appeal 2016-005325 Application 11/766,444 Claim 35 and 36 Appellants contend that “Jeon fails to disclose computing] any type of blood flow or oxygen consumption measurement using a metabolic model.” Br. 12. Appellants argue “Yodh’s model does not rely on both oxygen saturation and hemoglobin concentration,” and “Abrams does not teach or suggest any metabolic model.” Br. 13. Appellants err in attacking the references individually, as the rejection is based on a combination of references. See In re Merck & Co., Inc., 800 F.2d 1091, 1097 (Fed. Cir. 1986). The references cannot be read in isolation, but for what they teach in combination with the prior art as a whole. See id. We are not persuaded by Appellants’ contention that hemoglobin levels are not considered in Yodh’s calculations. Yodh measures “hemoglobin concentration and blood oxygen saturation from diffuse reflection spectroscopy (DRS) measurements, and blood flow from diffuse correlation spectroscopy (DCS) measurements.” FF4; see also Yodh 140 (“measured responses permit derivation of time curves for tissue oxygen saturation (% St02), total hemoglobin concentration (THC (//M)) and relative blood flow (rBF (%))”); see also Ans. 4. Specifically, Yodh explains that “[cjombinations of these parameters yield tissue total hemoglobin concentration (THC=CHb+CHb02) and tissue blood oxygen saturation (St02=[CHb02/(CHb+CHb02)]x 100).” Yodh 133; FF5. Yodh explains that “[t]he ability to evaluate how muscle blood flow responds to energy demands is a useful assessment took’ for determining patient parameters. Yodh | 62; see Ans. 5. 12 Appeal 2016-005325 Application 11/766,444 Furthermore, “[t]he claim does not indicate determining absolute value of oxygen consumption. . . . Yodh teaches a correlation between oxygen consumption and volumetric blood, as required by the claims.” Ans. 15 , see Ans. 4 (“tissue[s] ... are volumetric in nature”). Abrams “teaches determining ‘volumetric rate of blood flow’ of blood flowing in a blood vessel.” Ans. 4; FF6. Yodh also takes blood flow into consideration when deriving oxygen and hemoglobin concentrations. Specifically, Yodh teaches “measuring the flow of blood and oxygenation characteristics using diffuse optical spectroscopy and imaging, and diffuse-correlation methods” in tissues. Ans. 14; see also Yodh, Abstract (the “method includes measuring blood flow rate and oxygenation characteristics of the tissue, and determining oxygen metabolism of the tissue as a function of the measure blood flow rate and measure oxygenation”). We find no error with the Examiner’s conclusion that it would have been obvious to incorporate “additional considerations (cardiac output analysis) [as taught by Abrams] to augment Jeon in view of Yodh’s teachings for obtaining information about [how] volumetric tissue blood flow responds to energy demands.” Ans. 5. We affirm the rejection of claims 35 and 36 for the reason given by the Examiner in the Final Action and Answer. Claims 43 and 45 Appellants contend that Yodh’s model does not incorporate hemoglobin concentration. Moreover, Yodh’s model requires the calculation of the relative change in blood flow (rBF) as an input into for computing the relative change in oxygen consumption. The method recited in claim 43, however, computes these two parameters simultaneously using the appropriate metabolic model and 13 Appeal 2016-005325 Application 11/766,444 measurements of both hemoglobin concentration and oxygen saturation. Br. 15, see also 16 (same arguments apply to claim 45). The Examiner’s position is that [determining the oxygen saturation with respect to time, t, based on these other variables, therefore would be obvious to one of ordinary skill in the art, and manipulation of the variables in this present manner would not be outside the realm of this ordinary skill in the art; unless this present manner would provide a solution to a previously unsolved problem and/or produce unexpected results. Ans. 7. In other words, the Examiner’s position is that the combined references teach certain aspects of the claimed model such as determining oxygen saturation variables with respect to time, estimating an initial oxygen concentration, determining volumetric blood flow, and determining hemoglobin concentration, among others. See id. Because “the relationship among these variables . . . would be known to one of ordinary skill in the art at the time of the invention,” the Examiner finds arriving at the claimed model would have been obvious. Id. On this record, we find that Appellants have the better position. “[T]he examiner bears the initial burden, on review of the prior art or on any other ground, of presenting a prima facie case of unpatentability.” In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992). Just because the art teaches individual components that can be incorporated into a model does not mean that the ordinary artisan would have appreciated that weighing the relationship between the individual components could provide a specific calculation using the particular weighting factors as claimed. Accordingly, we reverse the rejections of claims 43 and 45 that rely on specific calculations and weighting factors. Because claim 46 depends 14 Appeal 2016-005325 Application 11/766,444 on a nonobvious claim we reverse the rejection of this claim as well. See In reFritch, 972 F.2d 1260, 1266 (Fed. Cir. 1992). II. Obviousness over Jeon, Yodh, Abrams, and Cabib Appellants do not separately argue the claims in this obviousness rejection directed to claims 49, 50, 52—54 and 61. Having affirmed the rejection of independent method claim 33 over Jeon, Yodh, and Abrams for the reasons given above (/.), we find that the further combination with Cabib renders the device of claims 49, 50, 52—54 and 61 obvious for the reasons given by the Examiner. Ans. 8—11. Claim 51 For the same reasons set out above with respect to claims 35 and 36, we are not persuaded by Appellants’ contention that the Examiner erred in making the rejections. We affirm the rejection of claim 51 for the reasons set out above and those given by the Examiner in the Answer. Ans. 10. Claims 56 and 58 Appellants contend that Yodh’s model does not incorporate hemoglobin concentration. Moreover, Yodh’s model requires the calculation of the relative change in blood flow (rBF) as an input into for computing the relative change in oxygen consumption. The method recited in claim 56, however, computes these two parameters simultaneously using the appropriate metabolic model and measurements of both hemoglobin concentration and oxygen saturation. Br. 19, see also 20 (same arguments apply to claim 58). On this record, we find that Appellants have the better position. “[T]he examiner bears the initial burden, on review of the prior art or on any other ground, of presenting a prima facie case of unpatentability.” In re 15 Appeal 2016-005325 Application 11/766,444 Oetiker, 977 F.2d at 445. Just because the art teaches each individual component that can be incorporated into a model does not mean that the ordinary artisan would have appreciated that weighing the relationship between the individual components could provide a specific calculation using the particular weighting factors as claimed. Accordingly, we reverse the rejections of claims 56 and 58 that rely on specific calculations and weighting factors. Because claims 44, 47, 57, 59, and 60 are dependent on a nonobvious claims 43, 45, 56, and 58, we reverse the rejection of these claims as well. SUMMARY We affirm the rejection of claims 33—38 and 40-42 under 35 U.S.C. § 103(a) as unpatentable over Jeon, Yodh, and Abrams. We reverse the rejection of claims 43, 45, and 46 under 35 U.S.C. § 103(a) as unpatentable over Jeon, Yodh, and Abrams. We affirm the rejection of claims 49—54 and 61 under 35 U.S.C. § 103(a) as unpatentable over Jeon, Yodh, Abrams, and Cabib. We reverse the rejection of claims 44, 47, and 56—60 under 35 U.S.C. § 103(a) as unpatentable over Jeon, Yodh, Abrams, and Cabib. TIME PERIOD FOR RESPONSE 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-IN-PART 16 Copy with citationCopy as parenthetical citation