12446144 (P.T.A.B. Aug. 24, 2016)

Ex Parte Nakajima et al

Patent Trial and Appeal BoardAug 24, 2016

12446144 (P.T.A.B. Aug. 24, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 12/446,144 12/22/2010 27896 7590 08/26/2016 EDELL, SHAPIRO & FINNAN, LLC 9801 Washingtonian Blvd. Suite 750 Gaithersburg, MD 20878 FIRST NAMED INVENTOR Toshiaki Nakajima 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. 2660.0007C 3683 EXAMINER AGAHI,PUYA ART UNIT PAPER NUMBER 3735 NOTIFICATION DATE DELIVERY MODE 08/26/2016 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): epatent@usiplaw.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte TOSHIAKI NAKAJIMA AND YOSHIAKI SATO Appeal2014-008969 Application 12/446,144 Technology Center 3700 Before ERIC B. GRIMES, ULRIKE W. JENKS, and ROBERT A. POLLOCK, Administrative Patent Judges. PERCURIAM DECISION ON APPEAL This is a decision on appeal 1 under 35 U.S.C. Â§ 134 from the Examiner's rejection of claims 1-10. We have jurisdiction under 35 U.S.C. Â§ 6(b ). We reverse. STATEMENT OF THE CASE The Specification discloses "a therapeutic device that can be applied to ... [the] treatment of metabolic syndrome" (Spec. 1:6-7). The Specification discloses that the device or system comprises a belt having a 1 Appellants identify the Real Party in Interest as Kaatsu Japan Co., Ltd (App. Br. 3). Appeal2014-008969 Application 12/446,144 "length that is enough to be wrapped around a predetermined range of muscles of one of the limbs; fastening means for fastening said belt ... and a gas bag provided in or on said belt" (Spec. 7:5-9). The Specification discloses that the gas bag is "adapted to apply a predetermined compression pressure to said predetermined range of muscles by means of compressing said predetermined range of muscles when said gas bag is filled with gas" (Spec. 7:9-13). The Specification discloses that the device comprises a "pressure setting means which is capable of setting a gas pressure within said gas bag to a predetermined pressure; [and] control means for controlling said pressure setting means" (Spec. 7: 15-1 7). Claims 1-10 are on appeal. Claim 1 is representative of the claims on appeal and is reproduced in the Claims Appendix of the Appeal Brief. 2 Issue The Examiner has rejected claims 1-10 under 35 U.S.C. Â§ 103(a) as obvious in view of Sato3 and Souma4 (Ans. 2, Fin. Rej. 5 3-7).6 2 Appellants' Appeal Brief, filed May 28, 2014, does not contain page numbers. For reference purposes we consecutively count the pages starting with the cover page as page one of the Appeal Brief. 3 Yoshiaki Sato et al., CA 2529808, published Dec. 29, 2004 4 Takahiro Souma, US 5,197,478, issued Mar. 30, 1993 5 Office Action mailed August 29, 2013. 6 The Final Rejection indicates that only claims 1-7, 9, and 10 are rejected as obvious in view of Sato and Souma (Fin. Rej. 3). However, this statement of the rejected claims appears to be in error because claims 1-10 are pending, and the summary sheet of the Final Rejection (p. 1) indicates that claims 1-10 stand rejected. We note that Appellants appear to understand that claims 1-10 have been rejected as being obvious in view of Sato and Souma (see App. Br. 10). 2 Appeal2014-008969 Application 12/446,144 The issue presented is: Does the evidence of record support the Examiner's conclusion that it would have been obvious to one of skill in the art, in view of Souma, to modify the Sato' s therapeutic system to include a control means that is adapted to execute both a preprocessing process and a normal processing process, wherein a maximum pulse wave pressure (i.e., gas pressure within the gas bag at the time point at which the amplitude of the pulse wave has reached its maximum) is determined during the preprocessing process and wherein the "pressure setting means sets the gas pressure within said gas bag to said maximum pulse wave pressure" during the normal processing process, and thereby arrive at the therapeutic system of claim 1? Findings of Fact 1. Sato discloses "a muscle strength development apparatus suitable for a pressure muscle strength increasing method" (Sato 1:9-13). 2. Sato discloses a tight fitting device that can encircle a limb. "This tight fitting device 100 basically comprises a belt 110, a gas bag 120, and a fastening member 130" (Sato 20:26-28). 3. Sato discloses that a "pressure setting segment 200 may have any one of possible configurations as long as it can supply a gas to the gas bag 120 and remove the gas from the gas bag 120" (Sato 23:23-25). 4. Sato discloses that a quantification segment 300 is adapted to quantify, at a position closer to the distal end of the limb, the quantification target that is associated with the state of blood flow through the limb ... [wherein] the quantification target varies depending on the compression force applied by the tight fitting device .... 3 Appeal2014-008969 Application 12/446,144 [Q]uantification segment 300 ... can quantify at least one of Korotkoff sounds, Swan sounds, and pulse waves. (Sato 24: 10-27.) "[P]ulse waves are the waveforms over the body surface representing volumetric changes in the blood vessels as blood pulses through certain regions of body tissues. A sphygmograph is a device known to be used for detecting pulse waves ... [and] it may be used as the quantification segment 300" (Sato 25:5-10). 5. Souma discloses an automatic sphygmomanometer that is arranged to predict, on the basis of the relationship between cuff pressure and the amplitude of a pulse wave, maximal and minimal blood pressures .... [I]t is possible to minimize the discomfort inflicted upon the subject due to pressure and a lengthy operation. Moreover, this ... eliminates the awkward operation of setting a pressure which is approximately 30 mmHg higher than the expected maximal blood pressure. (Souma, Abstract.) 6. Figure 2 of Souma is shown below: ;liiP.:; ,Â« i5i"f'2 'e O â€¢;.; Â·p~Â·t'{;~; ~;o.;5Â·0% Figure 2 shows "a graphic representation showing the relationship between time and the amplitude of a pulse wave signal when the rate of pressure- increase is constant" (Souma, coL 3~ L 67----col. 4, L 2). Souma discloses that, "[a]s the cuff pressure is increased, the amplitude of the pulse wave signal gradually increases, and after this amplitude passes a peak point (PlÂ· P2), it gradually decays" (Souma, coL Si lL 26-29). "[A]s shown in FIG. 2, if the peak point of the amplitude of the pulse wave ... can be detected, it is 4 Appeal2014-008969 Application 12/446,144 possible to predict the maximal and minimal blood pressures of the subject" (Souma, coL 5, lL 29-----32). 7. Souma discloses that it is predicted that the minimal blood pressure is present in the neighborhood of an amplitude ... which corresponds to 80% of the amplitude of the peak position, that is, the peak point. ... and that the maximal blood pressure is present in the neighborhood of an amplitude . . . which corresponds to 50% of the amplitude of the peak point. . . . [The] numerical values, such as 80% and 50%, are not construed as restrictive values since they may vary, depending upon the construction of the hardware. (Souma, col. 5, 11. 33--43). 8. Souma discloses that, when the maximal blood pressure is to be measured, the pressure within the cuff 102 may be increased at a relatively high rate up to the instant of time slightly beyond the time corresponding to the peak position of the pulse-wave signal. ... [A ]fter the amplitude of the pulse-wave signal has reached the limit, the rate of pressure-increase is slowed down to initiate measurement of the maximal blood pressure. . . . [I]t is possible to measure the maximal blood pressure without the need to impose upon the arm of the subject a burden which is 30 mmHg greater than the expected maximal blood pressure as in the case of prior art sphygmomanometers. (Souma, col. 5, 11. 44---61.) 9. Souma discloses that a microprocessor "is affanged to operate in accordance with the process procedure (program) shown in the flowchart of FIGS. 4(a) to 4(cf' (Souma~ coL 4~ IL 19-24). 5 Appeal2014-008969 Application 12/446,144 10. Figures 4(a}-4(c) of Souma are shown below: (~) v ~--------------'-'""'""Â·-----; -----'--- s~~ : ~~~~~~~:'. ~~;?1;;:;2'.1 L ________ ,,.::::~~~~~Â·:::::::JÂ·----------Â·--...... ..- ' r-~;f;jÂ·-~t;~\.~:;;~,~;~~1~------1---~-~~~~ ~ ... '<:t-~~.;:_- M.:V ~Â«.,.;:.,.";$Â£ Â· .â€¢ '>'!-\.~,..,:~~ \ ..................... -.~~-.---.---Â·""""- (=~~~:~~::~~~~~) FfG.4 fcl Figures 4( a), 4(b ), and 4( c) "are flow charts which ... illustrate a process procedure for measuring blood pressure" (Souma, coL 4, !L 6-8). 11. Souma discloses that "[a]fter the pulse-wave signal of maximum amplitude has been measured, the process proceeds to Step S8, where the pressure in the cuff 102 and the amplitude of the pulse-wave signal which are obtained at this time are stored in RAM lOlb of the memory 101" (Souma, coL 6, lL 53-57). Analysis The Examiner finds that Sato discloses a therapeutic system comprising "a tight fitting device including a belt having the length that is enough to be wrapped around a predetermined range of muscles of one of the limbs ... [and] fastening means for fastening said belt" (Fin. Rej. 3, citing Sato, 20 :21-21: 6). The Examiner finds that Sato does not disclose a control means that is adapted to execute both a preprocessing process and a normal processing process wherein the preprocessing process determines "a 6 Appeal2014-008969 Application 12/446,144 maximum pulse wave pressure that is a gas pressure within said gas bag at the time point at which the amplitude of the pulse wave has reached its maximum" and wherein, during the normal processing process, the "pressure setting means sets the gas pressure within said gas bag to said maximum pulse wave pressure" (Fin. Rej. 4). The Examiner finds that Souma discloses "an automatic sphygmomanometer for predictively measuring pressure by sampling pulse wave signal" (Fin. Rej. 4, citing Souma, the title). The Examiner finds that "Souma's process of determining the maximum pulse wave prior to storing the obtained data value( s) in RAM 101 b reads on preprocessing. Subsequently, applying the stored values so as to administer a new blood pressure test reads on normal processing" (Fin. Rej. 5). The Examiner concludes that one of ordinary skill in the art "would have had predictable success incorporating Souma and Sato because doing so would reduce the discomfort inflicted upon the arm of the subject" (Fin. Rej. 5, citing Souma, col. 7, 11. 26-27). Appellants argue that Souma discloses a device that allows for "an expedited blood pressure measurement/test to enable a patient to endure the least amount of discomfort during the test" (App. Br. 13, citing Souma, col. 2, 11. 45-51 ). Appellants argue that, in Souma, "the determination/use of the maximum pulse wave pressure is for generating a predicted maximum/minimum blood pressure for a subject" (App. Br. 13, citing Souma, col. 5, 11. 26-43). Appellants argue that instant claim 1 "includes a limitation as follows: 'control said pressure setting means during said normal processing so that said pressure setting means sets the gas pressure within said gas bag to said maximum pulse wave pressure"' (App. Br. 14). 7 Appeal2014-008969 Application 12/446,144 Appellants argue that "the determination of the maximum pulse wave pressure during 'preprocessing' ultimately leads to the constant maintaining [sic] the gas pressure to this level during processing" (App. Br. 14, citing the Spec. 9-10). Appellants argue that Souma does not disclose setting "any values, but rather stores the numerical value of the maximum wave pulse measurement to use as a base-line predictor for the maximum and minimum blood pressure measurement for a patient" (App. Br. 16). Appellants argue that Souma does not disclose setting the maximum pulse wave pressure because "the pressure in the system is constantly increasing to a value above the maximum amplitude and then subsequently decrease [sic] to a value below the maximum amplitude to measure a patient's maximum and minimum blood pressure" (App. Br. 16). Appellants argue that Souma's system "merely stores the numerical value [] as a bench mark in order to change the rate of pressure increase/ decrease; the system does not set the pressure to the maximum wave pulse as disclosed in applicant's pending claim 1" (App. Br. 16-17). Appellants argue that "one of ordinary skill in the art would not look to Souma with respect to usage of the maximum wave pulse since Souma merely utilizes the maximum wave pulse calculation as a base-line numerical comparison threshold that is stored in the memory to allow for the adjustment in the rate of pressure increase during testing" (App. Br. 17). We agree with Appellants that the Examiner has not adequately explained why one of ordinary skill in the art, in view of Souma, would have modified the muscular strength enhancing system of Sato to set the gas pressure in the gas bag to the maximum pulse wave pressure. "In rejecting claims under 35 U.S.C. Â§ 103, the examiner bears the initial burden of 8 Appeal2014-008969 Application 12/446,144 presenting a prima facie case of obviousness. Only if that burden is met, does the burden of coming forward \vith evidence or argument shift to the applicant" In re Rijckaert, 9 F.3d 1531, 1532 (Fed. Cir. 1993) (citations omitted). Although Sato discloses detecting and quantifying pulse waves (FF 4), Sato does not disclose setting the pressure in the gas bag to the maximum pulse wave pressure. Souma discloses an automatic sphygmomanometer for measuring maximal and minimal blood pressures, wherein the maximum pulse wave pressure is determined and then used to estimate the maximal and minimal blood pressures (FFs 5-8). Souma discloses that this process facilitates a quicker and more comfortable blood pressure determination process (FF 5 and 8). The Examiner points to Souma's disclosure that the value of the pressure in the cuff when the pulse wave amplitude reaches a peak or maximum is stored in the memory (Souma, Fig. 4( a); see FF 11 ). However, Souma makes clear that this value is stored in the memory for the purposes of estimating the maximal and minimal blood pressures (FF 9). Souma does not disclose that the pressure in the cuff is set or maintained at this value. The Examiner asserts that one of skill in the art would have modified Sato' s device to set the pressure in the cuff to the maximum pulse wave pressure in order to make the device of Sato more comfortable. However, missing from the Examiner's analysis is evidence that an artisan would have a reason to choose the particular pressure in the cuff, in this case the maximum pulse wave pressure, to make the device more comfortable and still expect to achieve the muscle strengthening goals disclosed by Sato. See KSR Int 'l Co. v. Teleflex Inc., 550 U.S. 38, 418 (2007) (obviousness rejections require "some articulated reasoning with some rational underpinning"). 9 Appeal2014-008969 Application 12/446,144 Thus, we reverse the rejection of independent claim 1 and dependent claims 2-8 under 35 U.S.C. Â§ 103(a). Like claim 1, independent claim 9 also recites that a control means adapted to execute both a preprocessing process and a normal processing process and to "control said pressure setting means during said normal processing so that said pressure setting means sets the gas pressure within said gas bag to said maximum pulse wave pressure" (emphasis added). 7 As discussed above for claim 1, the Examiner has not adequately explained how the cited references would have made obvious a device that sets the gas pressure within the gas bag to the maximum pulse wave pressure. Thus, we also reverse the rejection of independent claim 9 under 35 U.S.C. Â§ 103(a) for the reasons discussed above. Independent claim 10 is directed to a control method that is carried out by a therapeutic device, where the method comprises, among other steps, the steps of: controlling said pressure setting means with said control means during said preprocessing so that said pressure setting means changes the gas pressure within said gas bag, and determines a maximum pulse wave pressure ... and controlling said pressure setting means with said control means during said normal processing so that said pressure setting means sets the gas pressure within said gas bag to said maximum pulse wave pressure. (emphasis added)8 7 The full text of claim 9 can be found in the Claims Appendix to the Appeal Brief (App. Br. 26-27). 8 The full text of claim 10 can be found in the Claims Appendix to the Appeal Brief (App. Br. 27-28). 10 Appeal2014-008969 Application 12/446,144 As discussed above for claim 1, the Examiner has not adequately explained how the cited references would have made obvious a device that sets the gas pressure within the gas bag to the maximum pulse wave pressure. Thus, we also reverse the rejection of independent claim 10 under 35 U.S.C. Â§ 103(a) for the reasons discussed above. SUMMARY We reverse the rejection of claims 1-10 under 35 U.S.C. Â§ 103(a). REVERSED 11