Ex Parte Lindsay et alDownload PDFPatent Trial and Appeal BoardFeb 6, 201311245751 (P.T.A.B. Feb. 6, 2013) 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. 11/245,751 10/07/2005 Erin Jessica Lindsay 0097Pa(16977) 5300 46909 7590 02/07/2013 TERUMO CARDIOVASCULAR SYSTEMS CORPORATION ATTN: GAEL DIANE TISACK 6200 JACKSON ROAD ANN ARBOR, MI 48103 EXAMINER WIEST, PHILIP R ART UNIT PAPER NUMBER 3761 MAIL DATE DELIVERY MODE 02/07/2013 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 ERIN JESSICA LINDSAY, ARTHUR D. GERSHOWITZ, and DANIEL W. VIITALA ____________________ Appeal 2010-006034 Application 11/245,751 Technology Center 3700 ____________________ Before: JOHN C. KERINS, BRETT C. MARTIN, and JEREMY M. PLENZLER, Administrative Patent Judges. PLENZLER, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF CASE Appellants seek our review under 35 U.S.C. § 134 of the Examiner’s decision rejecting claims 1-4 and 6-25. Claim 5 has been cancelled. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. Appeal 2010-006034 Application 11/245,751 2 CLAIMED SUBJECT MATTER Claims 1 and 22 are independent. Claim 1, reproduced below, is illustrative of the claimed subject matter: 1. An air removal device for removing air from blood flowing in a perfusion system, comprising: a chamber having a blood flow region at a lower end thereof and having an air collection region at an upper end thereof, said chamber further having an inlet, a blood outlet, and an air outlet vertically higher than said inlet; a vertical guide structure in said air collection region; a float disposed for vertical movement following said vertical guide structure, wherein said float has an effective density less than the density of said blood; a lever arm having a first end for following vertical movement of said float and having a second end pivotally mounted at a pivot point stationary with respect to said vertical guide structure; a valve coupled to said air outlet and to an intermediate point of said lever arm between said first and second ends for closing said air outlet when said float is at its vertically highest position; and a vacuum port coupled to said air outlet for coupling to a vacuum source, such that vacuum supplied to said air outlet tends to resist downward motion of said float. REJECTIONS 1. Claims 1-3, 6-8, and 20-23 are rejected under 35 U.S.C. § 103(a) as being unpatentable over Wright (US 5,429,595; iss. July 4, Appeal 2010-006034 Application 11/245,751 3 1995), Nuter (US 3,599,659; iss. Aug. 17, 1971), and Tamari (US 6,337,049 B1; iss. Jan. 8, 2002)1; 2. Claim 4 is rejected under 35 U.S.C. § 103(a) as being unpatentable over Wright, Nuter, Tamari, and Klaber (US 2,937,014; iss. May 17, 1960); 3. Claims 9-17, 24, and 25 are rejected under 35 U.S.C. § 103(a) as being unpatentable over Wright, Nuter, Tamari, and Weinstein (US 5,484,474; iss. Jan. 16, 1996); and 4. Claims 18 and 19 are rejected under 35 U.S.C. § 103(a) as being unpatentable over Wright, Nuter, Tamari, and Raneri (US 5,849,186; iss. Dec. 15, 1998). OPINION Claims 1-3, 7, 8, 20, 22, and 23 Claim 1 Claim 1 is directed to an “air removal device for removing air from blood flowing in a perfusion system” and recites “a float,” “a lever arm having a first end for following vertical movement of said float,” “a valve coupled to . . . an intermediate point of said lever arm between said first and second ends for closing said air outlet when said float is at its vertically highest position,” and “a vacuum port coupled to said air outlet for coupling to a vacuum source.” The Examiner cites Wright as teaching each of the features of claim 1, but notes that “Wright, however, does not specifically disclose that the float is connected to a lever arm that opens and closes the air outlet valve, nor does Wright specifically teach the use of a suction 1 Claims 6 and 21 were added as a new ground of rejection in the Examiner’s Answer. See Ans. 10. Appeal 2010-006034 Application 11/245,751 4 source [to] assist in the removal of air for the chamber.” Ans. 4. The Examiner cites Nuter as teaching a lever arm and reasons that it would have been an obvious engineering choice to one of ordinary skill in the art at the time of invention to modify the gas removal device of Wright with the lever arm-actuated air purge valve of Nuter in order to provide a well-known, alternate means for opening and closing an outlet valve in response to the level of fluid inside the device. Ans. 5-6. The Examiner additionally cites Tamari as teaching vacuum assist and further reasons that [i]t would have been obvious to one of ordinary skill in the art at the time of invention to modify the device of Wright and Nuter with the vacuum-assisted air purge port of Tamari in order to enable the air within the air outlet to be evacuated, thereby improving the speed and efficiency of the air removal. Doing so would reduce the time the air purge valve would need to be open and improve the ability of air to be removed from the chamber. Ans. 5. Appellants explain that “[w]hen ball valve 44 is closed [in Wright], a column of fluid is maintained above ball valve 44 within air exit line 50” and “[w]hen air enters the chamber, it is the weight of the fluid in air exit line 50 from the continuous bypass flow that causes ball valve 44 to drop, thereby opening the ball valve.” App. Br. 6. Appellants contend that “the inclusion of a lever arm [in Wright] would presumably destroy its operation since the lever arm would interfere with Wright’s ability to respond to the weight of the fluid.” Id. However, Appellants do not explain why the lever arm would necessarily interfere with Wright’s ability to respond to the weight of the fluid. Appeal 2010-006034 Application 11/245,751 5 Wright discusses the use of a column of fluid above the valve to ensure that the valve reopens when the fluid level below the valve is reduced. See col. 7, ll. 15-19. Wright further explains that “other mechanical means of continued resistance can be utilized” including “mechanical spring devices or any other device that can offer resistance and allow opening of the valve as solution empties in perfusate chamber 12.” Col. 7, ll. 21-25. A lever arm of the type disclosed in Nuter would be understood to be an “other mechanical means.” As explained by the Examiner, “[t]he increased mechanical advantage allows the valve to resist vacuum forces that result from high pressure differences between the chamber and its surroundings.” Ans. 12. Because Appellants have failed to persuasively explain why the lever arm would necessarily interfere with Wright’s ability to respond to the weight of the fluid, we are not apprised of Examiner error. Appellants additionally contend that because “there is no use in Nuter of vacuum pressure for pulling air through a valve, and therefore no suction force to be overcome[,] . . . one skilled in the art would not associate the mechanism of Nuter with the problem of overcoming vacuum pressure.” App. Br. 6. We disagree. Nuter specifically discusses the use of the lever arm over a continuum of design pressure ranges merely by lengthening the distance between the pivotal connection of the lower lever arm to the cradle bracket and the pivotal connection of the metallic float to the free end of the lower lever arm thus affording a greater mechanical advantage for the higher design pressure ranges. Col. 1, ll. 66-71. As the use of suction pressure at the air outlet provides a different pressure range for the system, we are not convinced that one skilled Appeal 2010-006034 Application 11/245,751 6 in the art would not look to the mechanism of Nuter to assist in overcoming vacuum pressure. Appellants further note that the valve 40 in Nuter “is not attached at a point on the lever arm between float pin 47 and arm pins 33 or 34; instead it is at the distal end of lever arm 30 in every embodiment shown.” App. Br. 7. The Examiner explains that “Figure 4 [of Nuter] illustrates an embodiment wherein the lever arm comprises a distal end 147 where the floating ball is attached [and] a hinge point 136 from where the lever arm pivots” with “[t]he valve activation means 121 [] attached at point 140, which is disposed horizontally between the distal end and the proximal hinge point (i.e. along an intermediate point of the lever arm), such that a mechanical advantage is provided, such that the valve may be opened with maximum torque.” Ans. 13. We agree. In Nuter, point 140 is at a location between horizontal ends (147, 136) of the lever. With regard to the Examiner’s modification of Wright to additionally include vacuum assist based on the disclosure of Tamari, Appellants contend that “the rejection fails to provide any motivation to combine a vacuum assist with a lever arm.” Appellants argue that “[t]he rejection fails to establish any real motivation for combining a lever arm with a float in an air removal device for a perfusion system as claimed” because “[i]t argues that speed and efficiency of air removal would be improved, but fails to establish any reasons why such alleged improvements would have been apparent from the references without hindsight use of appellant’s disclosure.” App. Br. 7. The Examiner’s proposed modification includes a substitution of one known air removal mechanism for another. “[W]hen a patent claims a structure already known in the prior art that is altered by the mere Appeal 2010-006034 Application 11/245,751 7 substitution of one element for another known in the field, the combination must do more than yield a predictable result.” KSR Int’l Co. v. Teleflex, Inc., 550 U.S. 398, 416 (2007). Wright and Tamari each include an air removal system for a blood reservoir including an air outlet in an extracorporeal circuit. A lower pressure (vacuum assist) at the air outlet would further facilitate removal of air from the within system. Therefore, the Examiner has a reasonable basis for finding that the vacuum assist of Tamari would have been a suitable substitute for the air outlet of Wright and has not based the proposed modifications on impermissible hindsight. Appellants provide no persuasive reason why a person of ordinary skill in the art could not have implemented such a substitution or why the results of the substitution would have been unpredictable. Appellants further contend that “the fact that elements from one reference would be contrary to the functioning of another reference with which the rejection would combine them is an important and relevant point because it demonstrates the lack of motivation for the alleged combination.” App. Br. 7. It is unclear which elements (and from which reference) Appellants consider being contrary to elements of another reference. Based on Appellants’ arguments, we are not apprised of any contradiction between the references and, accordingly, are not apprised of any further error by the Examiner. For the reasons set forth above, we sustain the rejection of claim 1. Claims 2, 3, 6-8, 20, and 21 depend from claim 1 and have not been argued separately. Therefore, claims 2, 3, 6-8, 20, and 21 fall with claim 1. Appeal 2010-006034 Application 11/245,751 8 Claim 22 Appellants note that “[c]laim 22 is directed to a method corresponding to the system of claim 1,” “includes essentially the same limitations as are relied on in responding to the rejection of claim 1,” and “is allowable for the same reasons.” App. Br. 8. We disagree for the reasons set forth above. Accordingly, we sustain the rejection of claim 22. Claim 23 depends from claim 22 and has not been argued separately. Therefore, claim 23 falls with claim 22. Claim 4 Appellants rely on the dependence from claim 1 for the patentability of claim 4, and maintain that the additional Klaber reference fails to correct alleged deficiencies in the references cited in rejecting claim 1. App. Br. 8. Because we disagree that those references are deficient in rendering claim 1 unpatentable, as discussed above, we sustain the rejection of claim 4. Claims 9-17, 24, and 25 Claims 9-17 Claim 9 depends from claim 1 and additionally recites “an arcuate manifold providing an arcuate blood flow path outside of said portion of said chamber having an upstream end and a downstream end” with “a slit aperture between said arcuate manifold and said portion of said chamber.” The Examiner acknowledges that “Wright, Tamari, and Nuter . . . do not specifically disclose that the blood inlet comprises an arcuate manifold having a slit aperture.” Ans. 8. The Examiner finds that Weinstein teaches “an arcuate flow path 34” and “[a] slit aperture (the opening between the Appeal 2010-006034 Application 11/245,751 9 arcuate flow path 34 and the chamber 12)” and reasons that “it would have been obvious . . . to modify the device and method of Wright, Tamari, and Nuter with the arcuate manifold and slit aperture . . . in order to improve the separation of gas and blood within the manifold.” Ans. 9. Appellants contend that “the toroidally-shaped housing cover 14 of Weinstein does not provide an arcuate flow path outside the cylindrical chamber, nor is it joined to the chamber by a slit aperture as recited in claim 9.” Ans. 8-9. The Examiner has provided a broad, but reasonable, interpretation of the arcuate manifold and slit aperture recited in claim 9. Appellants have not provided any argument regarding why the Examiner’s characterization of the “arcuate manifold” and “slit aperture” in Weinstein is incorrect. Thus, we are not apprised of Examiner error and we sustain the rejection of claim 9. Claims 11, 13, 16, and 17 each depend from claim 9. Claims 11 and 13 each recite the arcuate manifold including a channel defining an end ramp. Claim 16 recites that “said arcuate manifold has a cross-sectional area that is generally decreasing from said upstream end to said downstream end” and claim 17 recites “said arcuate manifold comprises a channel having a depth that generally decreases from said upstream end to said downstream end.” The Examiner finds that Weinstein teaches that “[t]he channel of the arcuate manifold has a depth that decreases from the inlet end to the outlet end, thereby forming an end ramp.” Ans. 8; see also Weinstein, Figures 2 and 4. Again, Appellants simply contend that these features are not present in Weinstein and have not provided any argument regarding why the Examiner’s characterization of the “arcuate manifold” and corresponding channel features in Weinstein is incorrect. App. Br. 9. Thus, we are not Appeal 2010-006034 Application 11/245,751 10 apprised of Examiner error and we sustain the rejection of claims 11, 13, 16, and 17. Claims 10, 12, 14, and 15 depend from claim 9 and have not been argued separately. Thus, claims 10, 12, 14, and 15 fall with claim 9. Claims 24 and 25 Appellants rely on the dependence from claim 22 for the patentability of claims 24 and 25. Appellants do not contend that Weinstein corrects any alleged deficiencies in the references cited in rejecting claim 22. App. Br. 9. Because we disagree that those references are deficient in rendering claim 22 unpatentable, as discussed above, we sustain the rejection of claims 24 and 25. Claims 18 and 19 Appellants rely on the dependence from claim 1 for the patentability of claims 18 and 19, and maintain that the additional Raneri reference fails to correct alleged deficiencies in the references cited in rejecting claim 1. Id. Because we disagree that those references are deficient in rendering claim 1 unpatentable, as discussed above, we sustain the rejection of claims 18 and 19. DECISION We AFFIRM the Examiner’s decision to reject claims 1-4 and 6-25. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv). AFFIRMED Klh Copy with citationCopy as parenthetical citation