Ex Parte SadakaDownload PDFPatent Trial and Appeal BoardMay 18, 201612425191 (P.T.A.B. May. 18, 2016) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE FIRST NAMED INVENTOR 12/425,191 04/16/2009 Alain Sadaka 79292 7590 05/19/2016 Boston Scientific Corporation c/o Lowe Graham Jones 701 Fifth Avenue Suite 4800 Seattle, WA 98104 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. 1362001-2001.1 2044 EXAMINER AKAR, SERKAN ART UNIT PAPER NUMBER 3737 MAILDATE DELIVERY MODE 05/19/2016 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 ALAIN SADAKA Appeal2014-001971 Application 12/425,191 Technology Center 3700 Before CHARLES N. GREENHUT, LISAM. GUIJT, and MARK A. GEIER, Administrative Patent Judges. GUIJT, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Alain Sadaka (Appellant)1 appeals under 35 U.S.C. § 134(a) from the Examiner's decision to reject claims 1-11 and 13-20. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM-IN-PART. THE CLAIMED SUBJECT MATTER Claims 1, 14, and 19 are the independent claims on appeal. Claim 1, reproduced below, is illustrative of the subject matter on appeal. 1 Appellant identifies the real party in interest as Boston Scientific Corporation. Appeal Br. 2. Appeal2014-001971 Application 12/425,191 1. A catheter assembly for an intravascular ultrasound system, the catheter assembly comprising: a catheter having a longitudinal length, a distal end, and a proximal end, the catheter comprising at least one telescoping section configured and arranged for extension and retraction; a sealable lumen extending along the longitudinal length of the catheter from the proximal end to the distal end and along the at least one telescoping section, and a movable plunger or movable seal in fluid communication with the lumen, the movable plunger or the movable seal providing a gas-tight seal, the movable plunger or the movable seal configured and arranged to automatically adjust position in respond to changes in volume of the lumen, including changes in the volume of the lumen due to extension nor retraction of the at least one telescoping section, when the lumen is filled with an acoustically-favorable medium and sealed; and an imaging core configured and arranged for inserting into the sealable lumen and for coupling to a control module. THE REJECTION Claims 1-11 and 13-20 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Shturman (US 5,331,947; iss. July 26, 1994), Pantages (US 2002/0151799 Al; pub. Oct. 17, 2002), and Hamilton (US 2003/0083547 Al; iss. May 1, 2003). ANALYSIS Independent claims 1 and 14, and dependent claims 2-11, 13, and 15-18 Regarding independent claims 1 and 14, the Examiner found, inter alia, that Shturman teaches a catheter assembly, as claimed, except that Shturman does not teach a telescoping section configured and arranged for 2 Appeal2014-001971 Application 12/425,191 extension and retraction, or a movable seal configured and arranged to automatically adjust position in response to changes in volume of the lumen of the catheter due to extension or retraction of the telescoping section. Final Act. 3--4. The Examiner relied on Pantages for teaching a telescoping section that extends and retracts (id. at 4, citing Pantages i-fi-19, 46) and on Hamilton for teaching a catheter that has a movable seal that automatically adjusts position in response to changes in volume in the lumen of the catheter (id., citing Hamilton i-fi-173-74, Fig. 15, reference numeral 1370). The Examiner reasoned that [i]t would have been obvious ... to modify the method and device of Shturman with [a] telescoping section that extends and retracts as taught by Pantages because [i]n the case of ultrasonic imaging, the elongate member can take the form of a telescoping guide sheath slidably disposed about an imaging core ... to provide the physician with two-dimensional 360[0 ] ultrasonic images of surrounding body tissue. Id. at 5 (citing Pantages i19). The Examiner further reasoned that [i]t would have been obvious ... to modify the method and device of Shturman with [a] movable seal ... that automatically adjust[ s] position in response to changes in volume in the lumen ... of the catheter as taught by Hamilton because controlling the pressure level within inflatable member 1310 using the pressure relief device 1370, the inflation of the inflatable member 1310 may be controlled so that the inflatable member 1310 is less likely to urge the window 108 away from the viewing aperture 63 during a medical procedure. Id. (citing Hamilton ,-r 74).2 2 Notably, the Examiner's reason for modifying Shturman to include Hamilton's pressure relief device 1370, namely, to control the pressure level, would appear to apply equally to controlling the pressure level in 3 Appeal2014-001971 Application 12/425,191 First, Appellant argues that "Hamilton teaches using the pressure relief system 1370 to be responsive to changes in pressure, not changes in volume." Reply Br. 2; see also Appeal Br. 7 (citing Hamilton i-f 73,3 Fig. 15). Appellant further argues that, even assuming Hamilton's relief system 1370 automatically adjusts to changes in volume, Hamilton's pressure relief system 1370 "could only [be] use[d] to respond as [a telescoping] section retracts (increase in pressure), but not as it expands (decrease in pressure)," whereas the claims require the plunger or moveable seal to adjust to both increases and decreases in lumen volume. Appeal Br. 8 (citing Hamilton i-fi-173, 74,4 Fig. 15); see also Reply Br. 4--5. The preponderance of evidence supports the Examiner's finding regarding Hamilton's piston 1370, as stated supra. Although Hamilton's pressure relief system 1370, which is depicted as including a moveable plunger, automatically adjusts position in response to changes in pressure within a lumen, the pressure change is at least partially a result of changes in the volume of the lumen due to inflatable member 1310. See Hamilton i-f 73, Fig. 15. In particular, Hamilton discloses that [a]s the inflatable member 1310 approaches the fully-inflated position, a back-pressure begins to occur within the inflation lumen 1368. In the fully-inflated position, the back-pressure Shturman's inflatable sheath 30, as modified by Pantages to include a telescoping section. See Final Act. 5. 3 Appellant appears to cite to the granted Hamilton patent, US 6,793,661 B2, iss. Sept. 21, 2004, rather than the publication US 2003/0083547 Al of US Application 10/313,848, to which the Examiner cites. Here, Appellant cites to col. 14, 11. 14--22, which corresponds to Hamilton i-f 73. 4 Appellant cites to col. 14, 11. 13--48, which corresponds to Hamilton i-fi-173, 74. 4 Appeal2014-001971 Application 12/425,191 reaches a predetermined level which causes the pressure relief device 1370 to release any additional pressurized liquid or gas supplied by the inflation source 1362 through the vent 1372. Hamilton i-f 73. Thus, the movable plunger of Hamilton's pressure relief device 1370 is configured and arranged to automatically adjust position in response to a change in the volume of inflation lumen 13 68 - a change from a volume defined by inflatable member 1310 in an uninflated condition to a volume defined by inflatable member 1310 in a fully-inflated condition. We also do not agree with Appellant that the independent claims require the movable plunger to be a two-way valve. Rather, the independent claims, as written, require "the movable plunger [to be] configured and arranged to automatically adjust position in response to changes in volume of the lumen," and an increase in volume that adjusts a one-way valve is a change in volume. Appeal Br. 15, 17, 18 (Claims App.) (emphasis added). The claim limitation, "including changes in the volume of the lumen due to extension or retraction of the at least one telescoping section," refers to examples of specific changes in volume, but is not interpreted to require them, and the claim term "or" is interpreted as meaning that either a change due to extension or retraction alone would suffice to meet the claim limitation. Id. In addition, Appellant's contention that "[t]here is no teaching or suggestion that the pressure relief system 1370 would automatically adjust position in response to extension or retraction of at least one telescoping section, as recited in the claims, because Hamilton does not contain the recited telescoping section," does not address the Examiner's proposed combination, which relies on Shturman, as modified by Pantages, for a 5 Appeal2014-001971 Application 12/425,191 telescoping section on a catheter assembly. See Reply Br. 3; see also Final Act. 4--5. Second, Appellant argues that Hamilton's apparatus "would be incapable of responding to such large changes in volume provided by the telescoping section of claim 1," because Hamilton's apparatus "is designed to respond to small changes in pressure, as demonstrated by the size of the pressure relief system 1370 of Figure 15." Appeal Br. 8; see also Reply Br. 3, 5. The Examiner responds that "'large changes of volume' is not [recited] in the claims," and further that "Hamilton does not provide any pressure rating." Ans. 9. The Examiner further finds that "it would have been an obvious matter of design choice to obtain, manipulate or change the size as well as the shape of the well-known pressure relief valves, since such a modification would have involved a mere change in size of a component." Id. at 10. Appellant replies that "[t]he recitation of the telescoping section implicitly includes the 'large changes in volume."' Reply Br. 5. Appellant's arguments fail to apprise us of error in the Examiner's reasoning that it is within the knowledge of one skilled in the art to design a pressure relief valve for use in Shturman's catheter assembly, as modified to include a telescoping section as taught by Pantages, which has a movable plunger configured and arranged to automatically adjust position (or open) in response to changes in volume of the lumen, for example, due to extension of a section of the lumen to a maximum volume, or retraction of a section of the lumen that increases the pressure within the lumen. See Ans. 10-11. Third, Appellant contends that Hamilton's apparatus "is only designed to assist the inflation source 1362 in initially inflating the lumen, not 6 Appeal2014-001971 Application 12/425,191 continually adjusting the volume of a lumen after inflation." Appeal Br. 9; see also Reply Br. 6. Thus, Appellant submits that the Examiner's proposed modification would impermissibly change the principle of operation of Hamilton's device from a device that "is meant to address overpressurization during inflation" to a device that addresses "changes in volume due to a telescoping section." Id. However, Appellant's argument does not address the Examiner's proposed combination, which modifies Shturman to include a telescoping section, as taught by Pantages, such that Hamilton's pressure relief valve, when incorporated into the modified Shturman catheter assembly, would adjust the pressure within the system during overpressurization occurring due to changes in volume occurring during inflation and also adjustment (i.e., retraction) of the telescoping section. Fourth, Appellant argues that Shturman, Hamilton, and Pantages all "fail to teach or suggest using a plunger or seal that is responsive to changes in lumen volume due to extension or retraction of the telescoping section." Appeal Br. 9; see also Reply Br. 7. The Examiner correctly responds that Appellant's argument is attacking the references individually, where the rejection is based on a combination of references. Ans. 11. Fifth, Appellant argues that "[ o ]ne skilled in the art would not find it obvious [to combine Shturman, Hamilton, and Pantages]" because the principle of operation of a device that is responsive to changes in lumen volume "is not disclosed in any of the cited references." Appeal Br. 10; see also Reply Br. 7. We disagree, for the reasons discussed supra (namely, that Hamilton's pressure relief device is at least indirectly responsive to changes in lumen volume). 7 Appeal2014-001971 Application 12/425,191 Sixth, Appellant argues that the "combined apparatus would operate differently than the devices of claims 1, 14, and 19." Appeal Br. 10. Appellant submits that because Hamilton's solution to an expanding telescoping section is to inject fluid into the lumen, a device resulting from the Examiner's proposed combination would "(a) run out of fluid to inject, rendering the device useless, or (b) require a large stockpile of extra lumen fluid for carrying out complex procedures." Id. Thus, Appellant concludes that "[t]he inflation system 1360 of Hamilton would be an impracticable way of adjusting to continuous changes in lumen volume." Id. We are not persuaded by Appellant's argument, which is speculative as to the respective sizes, for example, of (i) Pantages' s telescoping sections, as modified for use in Shturman's catheter assembly; (ii) Shturman's syringe; and (iii) Hamilton's pressure relief valve, as modified for use in Shturman's catheter assembly. Appellant has failed to present persuasive argument or evidence that the Examiner's proposed modification, which would necessarily include sizing components for achieving operational pressurization of the system, would not be within the knowledge of one skilled in the art. Seventh, Appellant argues that the Examiner erred in finding that ... Hamilton disclose[ s] a moveable seal or movable plunger that also seals a catheter lumen. Appeal Br. 11; see also Reply Br. 8-10. Specifically, Appellant submits that "Hamilton does not teach or suggest a seal;" Hamilton's element 1370 "is explicitly a vent." Id. Moreover, Appellant argues that if Hamilton's "pressure relief device 1370 was sealed, ... it would not fulfill its intended purpose of providing a vent when a catheter lumen is overpressurized." Id. at 12. We disagree. Hamilton depicts 8 Appeal2014-001971 Application 12/425,191 pressure relief valve 1370 as having a spring-biased, movable plunger that would necessarily provide a gas-tight seal, as claimed, when the movable plunger is closed because of low pressure within the system due to the volume of the system; otherwise, pressure relief valve 1370 would not allow inflatable member 1310 to inflate. See Hamilton i-f 73, Fig. 15. Thus, the preponderance of evidence supports that the movable plunger of Hamilton's pressure relief valve "provides a gas-tight seal," as claimed, at least in the closed position. Accordingly, we sustain the Examiner's rejection of independent claims 1 and 14. Appellant does not present separate arguments for the patentability of dependent claims 2-11, 13, and 15-18, which depend from independent claims 1 and 14. See Appeal Br. 12-13. Therefore, we also sustain the Examiner's rejection of claims 2-11, 13, and 15-18 for the reasons stated supra. Independent claim 19 and dependent claim 20 Claim 19 requires, in relevant part, "degassing a sealable lumen of the catheter." Appeal Br. 18 (Claim App.). Appellant's Specification discloses that "degassing involves generating a vacuum in the lumen 304 and then filling the lumen 304 with an acoustically-favorable medium without introducing gas into the lumen 304." Spec., p. 10, 11. 20-23. Appellant argues that "[ n ]one of the cited references teach or suggest degassing a sealable lumen of the catheter as recited in claim 19, nor does [the Examiner] assert that any of the references teach or suggest this element of claim 19." Appeal Br. 12; see also Reply Br. 10. Indeed, the Examiner does not address degassing in the Final Action. See Final Act 3-5. However, in the Examiner's Answer, the Examiner finds that "Hamilton also teaches a 9 Appeal2014-001971 Application 12/425,191 vent that is used for degassing of over pressurized gas or allowing the escape of over pressurized fluids." Ans. 12 (citing Hamilton i-fi-170-74). Hamilton's paragraphs 70 to 71 disclose an embodiment of Hamilton's endoscope assembly 1350 that includes sheath 1300, inflatable member 1310, inflation system 1360 (including plunger 1364 in sleeve 1366), and pressure relief device 1370, and Hamilton's paragraphs 72 to 74 disclose the operation of the pressure relief device, which releases pressurized liquid or gas through vent 1372, as discussed supra. See Hamilton i-fi-170-74. However, we are unable to find in these passages any reference to degassing, nor does the Examiner explain how or why it would be obvious to use Hamilton's pressure relief device 1370 to accomplish the claimed step of degassing. Accordingly, we do not sustain the Examiner's rejection of independent claim 19 and claim 20 depending therefrom. DECISION The Examiner's rejection of claims 1-11 and 13-18 under 35 U.S.C. § 103(a) is affirmed. The Examiner's rejection of claims 19 and 20 under 35 U.S.C. § 103(a) is reversed. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R. § 1.136(a)(l )(iv). AFFIRMED-IN-PART 10 Copy with citationCopy as parenthetical citation