Ex Parte NguyenDownload PDFBoard of Patent Appeals and InterferencesApr 20, 200910328224 (B.P.A.I. Apr. 20, 2009) Copy Citation UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE BOARD OF PATENT APPEALS AND INTERFERENCES __________ Ex parte NICK NGOC NGUYEN __________ Appeal 2009-1685 Application 10/328,224 Technology Center 3700 __________ Decided:1 April 21, 2009 __________ Before ERIC GRIMES, LORA M. GREEN, and RICHARD M. LEBOVITZ, Administrative Patent Judges. GRIMES, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134 involving claims to a method of detecting proper flow through a channel in an endoscope during a 1 The two-month time period for filing an appeal or commencing a civil action, as recited in 37 C.F.R. § 1.304, begins to run from the decided date shown on this page of the decision. The time period does not run from the Mail Date (paper delivery) or Notification Date (electronic delivery). Appeal 2009-1685 Application 10/328,224 2 cleaning procedure. The Examiner has rejected the claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. STATEMENT OF THE CASE Claims 1-9 are pending and on appeal. Claim 1 is representative and reads as follows: Claim 1: A method during a cleaning procedure of detecting proper flow through one or more channels in an endoscope, the method comprising the steps of: a) connecting a first supply line to at least one of the one or more channels, the supply line being in fluid communication with a fluid supply vessel; b) flowing, for a time period, fluid from the fluid supply vessel through the first supply line into the one of the one or more channels; c) determining an amount of fluid which has been flowed through the first supply line by determining a volume change of fluid in the fluid supply vessel; d) calculating a flow rate through the first supply line based upon the amount of fluid which has been flowed through the first supply line and the time period; and e) comparing the flow rate through the first supply line to a predetermined value and if it varies by more than a predetermined amount from the predetermined value providing an indication of improper flow; wherein the fluid supply vessel comprises a tank of known dimensions and a level sensing mechanism and wherein the step of determining the volume change of fluid in the fluid supply vessel comprises, with the level sensing mechanism, sensing the level of fluid in the tank prior to the time period and after the time period and calculating the volume change based thereupon. The claims stand rejected under 35 U.S.C. § 103(a) as follows: • claims 1 and 4-9 in view of Pfeifer2 and Mariotti3; and 2 Pfeifer, US 5,738,824, Apr. 14, 1998 3 Mariotti, US 5,882,589, March 16, 1999 Appeal 2009-1685 Application 10/328,224 3 • claims 2 and 3 in view of Pfeifer, Mariotti, and Walta.4 OBVIOUSNESS Issue The Examiner has rejected claims 1 and 4-9 under 35 U.S.C. § 103(a) as being obvious in view of Pfeifer and Mariotti. The Examiner finds that Pfeifer discloses an endoscope cleaning method comprising steps a) through e) of claim 1 (Ans. 4) but does not use a tank of known dimensions and a level sensing mechanism to calculate the volume change in the fluid supply vessel (id. at 5). The Examiner finds that Mariotti discloses a device for cleaning and disinfecting an endoscope, with the device “having a plurality of sensors located throughout the system to provide feedback to the CPU” and discloses sensors that “include high and low level sensors 302 and 304 which monitor the level of disinfectant concentrate in the tank 144” (id.). The Examiner concludes that it “would have been obvious to one skilled in the art to include level sensors in the apparatus of Pfeifer in order to ensure that the amount of detergent injected is always equal to the exact volumetric difference between the high and low sensor levels” (id. at 5-6). Appellant contends that the Examiner erred in finding that one of skill in the art would have been motivated to combine the level sensors of Mariotti with the device of Pfeifer because “Pfeifer uses the principle of measuring the pressure drop, not the principle of measuring a volume to determine flow through a channel” (App. Br. 4). 4 Walta, US 6,260,560 B1, Jul. 17, 2001 Appeal 2009-1685 Application 10/328,224 4 The issue with respect to this rejection is: Does the evidence of record support the Examiner’s conclusion that one of skill in the art would have been motivated to use the Mariotti level sensors to determine volume change in Pfeifer’s fluid supply vessel? Findings of Fact 1. Pfeifer discloses a “method for the testing and cleaning of instruments for minimal invasive surgery or minimal invasive examination of body cavities,” including endoscopes (Pfeifer, col. 1, ll. 8-10, 36-38). 2. Pfeifer describes its testing method as follows: (a) the channel of the or each instrument is connected to a fluid source; (b) the channel is tested for penetrability; (c) if there is too little or no throughflow, the instrument in question is recognized as being one that cannot be adequately flushed and is registered for rejection, and (d) if the throughflow is sufficient, the instrument in question is recognized as being one that can be flushed and it is re-flushed with disinfecting and/or cleaning agents. (Id. at col. 3, ll. 9-19.) 3. Pfeifer discloses that “the channel is tested for penetrability by means of fluid being delivered to it from the fluid source, a quantity of the fluid flowing through the channel in one unit of time being determined, and the fluid volume determined being compared with preset data specific to the device” (id. at col. 3, ll. 19-24). 4. Pfeifer discloses that, “[i]n a preferred embodiment … , the throughput rate is determined at the outlet side, … after flowing through the channels. … [I]t is also possible, however, for the fluid quantity flowing through a channel to be determined at the inlet side.” (Id. at col. 3, ll. 59- 64.) Appeal 2009-1685 Application 10/328,224 5 5. Pfeifer discloses that, [i]n an alternative embodiment of the invention, the at least one channel of one or more instruments is tested for penetrability by means of this channel being subjected to pressure by delivery of fluid from a pressurized fluid source, the pressure drop over time as a result of a flow of fluid through the channel being measured, and the determined pressure drop being compared with preset data specific to the device. (Id. at col. 3, ll. 65-col. 4, l. 5.) 6. Mariotti discloses an endoscope cleaning device “into which the endoscope may be completely immersed. It is equipped with injectors arranged so as to create a rotating flow of cleaning liquid and sterile rinsing water or recycled drying air within the basin.” (Mariotti, col. 2, ll. 57-64.) 7. Mariotti discloses that a plurality of sensors located throughout the system provide feedback to the CPU, so as to enable it to control the overall operation of the device and various components thereof. Referring to FIG. 6, the sensors include: high and low level sensors 302, 304 respectively, which monitor the level of disinfectant concentrate in tank 166. (Id. at col. 6, ll. 15-20.) 8. Mariotti discloses that the amount of disinfectant concentrate added is precisely measured in tank 166. High level sensor 302 is used to limit filling disinfectant tank 166. Subsequently, a signal from low level sensor [304] causes CPU 300 to deactivate pump 170 when the level of disinfectant in tank 166 reaches low level sensor 304. In this manner, the amount of detergent [sic, disinfectant] injected is always equal to the exact volumetric difference between the high and low sensor levels. (Id. at col. 8, ll. 52-62.) Appeal 2009-1685 Application 10/328,224 6 Principles 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.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, __, 127 S.Ct. 1727, 1739 (2007). “[W]hen the 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 __, 127 S. Ct. at 1740. The obviousness analysis “can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” Id. at __, 127 S. Ct. at 1741. Analysis Claim 1 is directed to a method of detecting proper flow through a channel in an endoscope. The Examiner finds, and Appellant does not dispute, that Pfeifer teaches the steps a) through e) recited in claim 1. Claim 1 also requires that the “fluid supply vessel comprises a tank … and a level sensing mechanism” and that “the step of determining the volume change … comprises, with the level sensing mechanism, sensing the level of fluid in the tank prior to the time period and after the time period and calculating the volume change.” Pfeifer discloses that the rate of flow through an instrument can be determined at the outlet side or at the inlet side, or in “an alternative embodiment” can be measured based on pressure drop over time in a pressurized fluid source. Pfeifer does not disclose using a fluid supply vessel tank containing a level sensing mechanism or that “the step of determining the volume change … comprises, with the level sensing Appeal 2009-1685 Application 10/328,224 7 mechanism, sensing the level of fluid in the tank” prior to and after the time period for fluid flow. Mariotti discloses a tank having high and low level sensors that detect the amount of disinfectant concentrate added during an endoscope cleaning procedure. That is, Mariotti teaches that an alternative method of measuring the volume of fluid that has been injected is to use a tank of known dimensions and a level-sensing mechanism. In view of these disclosures, it would have been obvious to one of skill in the art to use the tank and fluid level sensors of Mariotti in the Pfeifer method because one of skill in the art would have appreciated that such sensors would be an alternative mechanism to measure volume change in the tank and thus volume flow through the channel being tested. Such a combination appears to be the predictable use of prior art elements according to their established functions. Appellant contends that the Examiner erred in finding that one of skill would have been motivated to combine the level sensors of Mariotti with the device of Pfeifer because “Pfeifer uses the principle of measuring the pressure drop, not the principle of measuring a volume to determine flow through a channel” (App. Br. 4). This argument is not persuasive. As set forth above, Pfeifer specifically discloses that the channel is tested for penetrability by means of “a quantity of the fluid flowing through the channel in one unit of time,” with the quantity of fluid being measured either at the outlet side or the inlet side, and that an alternative embodiment is testing for a pressure drop after pressurized fluid delivery. Thus, one of skill in the art would have understood Pfeifer’s disclosure to mean that the quantity of fluid flowing through the channel could be measured by any of a variety of methods, Appeal 2009-1685 Application 10/328,224 8 including a volume determination at the inlet side or the outlet side. Mariotti teaches that one method of measuring the amount of fluid dispensed from a tank (or, in other words, the amount of fluid flowing into the inlet of a vessel) is to use a level-sensing mechanism to measure the volume of fluid that has left a storage tank. A person of ordinary skill in the art would have recognized that this principle would be equally applicable to Pfeifer’s system. With reference to claim 6,5 Appellant contends that the claim “defines the level sensing mechanism comprising a reference connection at a lower portion of the tank and a plurality of sensing electrodes there above. The references are silent as to such arrangement.” (App. Br. 4.) This argument is not persuasive. While Mariotti discloses only two specific sensors in its level-sensing mechanism, “[i]n determining whether obviousness is established by combining the teachings of the prior art, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art.” In re GPAC Inc., 57 F.3d 1573, 1581 (Fed. Cir. 1995) (internal quotations omitted). Here, Pfeifer’s system requires injecting, and measuring, variable amounts of fluid through an endoscope channel. Therefore, it would have been obvious to a skilled artisan – in view of the teachings of the combined 5 Claim 6 reads: “[A method according to claim 1 wherein the level sensing mechanism comprises a plurality of sensors vertically arrayed within the tank] wherein the level sensing mechanism comprises a reference connection at a lower portion of the tank and [a] plurality of sensing electrodes thereabove and the method of sensing the level of fluid in the tank comprises sensing electric current flow from the reference connection through the fluid in the tank to the highest electrode to receive such current flow.” Appeal 2009-1685 Application 10/328,224 9 references – to include a plurality of sensors (sensing electrodes) at higher levels than a low-level sensor (reference electrode), in order to measure different quantities of fluid dispensed from the storage tank. Such a sensor arrangement appears to be, in accord with KSR Int’l Co. v. Teleflex Inc., well within the realm of the inferences and creative steps that one of skill in the art would employ. The Examiner has rejected claims 2 and 3 under 35 U.S.C. § 103(a) as being obvious in view of Pfeifer, Mariotti, and Walta. Claim 3 has not been argued separately and therefore stands or falls with claim 2.6 37 C.F.R. § 41.37(c)(1)(vii). The Examiner relies on Pfeifer and Mariotti as discussed above, and finds that Walta discloses the additional limitations of claim 2 (Ans. 6-7). The Examiner concludes that it “would have been obvious to one skilled in the art … to use the device and method of Walta in the apparatus of Pfeifer and Mariotti … so that during cleaning and/or disinfecting of the endoscope only single channels are present, and therefore the cleaning and the disinfection system are more efficient and operationally reliable as taught by Walta” (id. at 7). We agree with the Examiner’s reasoning and conclusion. Appellant does not dispute that Walta would have suggested the limitation added to claim 1 by claim 2, but contends that Walta does not cure 6 Claim 2 reads: “A method according to claim 1 and further comprising the steps of connecting a second supply line to a separate channel within the endoscope, the second supply line being in fluid communication with the fluid supply vessel, and repeating steps b) through e) for the second supply line.” Appeal 2009-1685 Application 10/328,224 10 the deficiencies of the combination of Pfeifer and Mariotti in suggesting the invention of claim 1 (App. Br. 4-5). This argument is not persuasive because, for the reasons discussed above, we conclude that the combination of Pfeifer and Mariotti would have suggested the invention of claim 1. CONCLUSIONS OF LAW The evidence of record supports the Examiner’s conclusion that one of skill in the art would have been motivated to use the Mariotti level sensors to determine volume change in the fluid supply vessel in the Pfeifer method. SUMMARY We affirm the rejection under 35 U.S.C. § 103(a) of claims 1 and 6 as being obvious in view of Pfeifer and Mariotti. Claims 4, 5, and 7-9 fall with claim 1. 37 C.F.R. § 41.37(c)(1)(vii). We affirm the rejection of claims 2 and 3 as being obvious in view of Pfeifer, Mariotti, and Walta. 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 LP Appeal 2009-1685 Application 10/328,224 11 K&L GATES LLP 535 SMITHFIELD STREET PITTSBURGH PA 15222 Copy with citationCopy as parenthetical citation