Ex Parte Lau et alDownload PDFPatent Trials and Appeals BoardMar 18, 201913215576 - (D) (P.T.A.B. Mar. 18, 2019) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 13/215,576 08/23/2011 30452 7590 03/19/2019 EDWARDS LIFESCIENCES CORPORATION LEGAL DEPARTMENT ONE EDWARDS WAY IRVINE, CA 92614 FIRST NAMED INVENTOR Jackie Lau 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. ECV-6389 2470 EXAMINER TON, MARTIN TRUYEN ART UNIT PAPER NUMBER 3771 MAIL DATE DELIVERY MODE 03/19/2019 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 JACKIE LAU, JOHN PETERSON, GRACE KIM, JOHN F. MIGLIAZZA, and TRAVIS OBA Appeal2018-003688 Application 13/215,576 1 Technology Center 3700 Before WILLIAM V. SAINDON, MICHAEL L. HOELTER, and RICHARD H. MARSCHALL, Administrative Patent Judges. MARSCHALL, Administrative Patent Judge. DECISION ON APPEAL Appellants seek our review under 35 U.S.C. § 134(a) of the Examiner's rejection of claims 27--40. We have jurisdiction under 35 U.S.C. § 6(b ). We REVERSE. 1 According to Appellants, the real party in interest is Edwards Lifesciences Corporation. Appeal Br. 2. Appeal2018-003688 Application 13/215,576 THE CLAIMED SUBJECT MATTER The claimed subject matter "relates generally to devices and procedures related to heart valve replacement, and, more particularly, to a color-coded prosthetic valve system." Spec. ,r 2. Claims 1, 17, and 18 are independent. Claim 1 is reproduced below. 27. A color-coded prosthetic heart valve delivery system compnsmg: an implantable heart valve; and a valve holder attachable to the heart valve with sutures so as to be stationary with respect to the heart valve until the sutures are severed and the valve holder and valve are detached, the valve holder having a first color and being adapted to remain attached to the heart valve during delivery, the heart valve being inoperable until the valve holder is detached therefrom; a valve delivery deployment mechanism integrated with the valve holder so as to be detached from the heart valve with the valve holder, the mechanism including a movable part that is movable with respect to the valve holder to convert the heart valve to a delivery configuration, wherein the valve holder and a proximal end of the movable part are visible on the inflow end of the valve, wherein the movable part comprises an adapter sutured to a proximal end of a post that translates through a central bore in the holder and through the valve to convert the heart valve to the delivery configuration, the adapter having a second color distinct from the first color, and the valve holder, the post, and the adapter each has a color that is in contrast to one another such that the holder is visually distinguishable from the post and the adapter, and the post is visually distinguishable from the adapter; and a flexible delivery handle having a distal end adapted to engage and move the movable part and convert the heart valve to its delivery configuration, the handle having a grip in the second color to facilitate the valve deployment operation. Appeal Br. 14 (Claims App.). 2 Appeal2018-003688 Application 13/215,576 THE REJECTIONS Appellants appeal from the following rejections: 1. Claims 27-30 under 35 U.S.C. § I03(a) as unpatentable over Stobie, 2 Kieturakis, 3 Henke, 4 and Treace. 5 2. Claims 31 and 32 under 35 U.S.C. § I03(a) as unpatentable over Stobie, Kieturakis, Henke, Treace, and Ranalletta. 6 3. Claim 33 under 35 U.S.C. § I03(a) as unpatentable over Stobie, Kieturakis, Henke, Treace, and Lemmon. 7 4. Claims 34--38 under 35 U.S.C. § I03(a) as unpatentable over Stobie, Kieturakis, Ranalletta, and Treace. 5. Claim 39 under 35 U.S.C. § I03(a) as unpatentable over Stobie, Kieturakis, Ranalletta, Treace, and Lemmon. 6. Claim 40 under 35 U.S.C. § I03(a) as unpatentable over Stobie, Kieturakis, Ranalletta, Treace, and Henke. ANALYSIS Independent Claim 2 7 Independent claim 27 requires a "valve holder," "post," and "adapter," where each of the three parts "has a color that is in contrast to one another." Appeal Br. 14 (Claims App.). Claim 27 also requires a handle grip having the same "second color" as the adapter. Id. The Examiner found that Stobie 2 U.S. Patent No. 6,966,925 B2, issued November 22, 2005 ("Stobie"). 3 U.S. Patent No. 5,607,443, issued March 4, 1997 ("Kieturakis"). 4 U.S. Patent No. 6,668,751 Bl, issued December 30, 2003 ("Henke"). 5 U.S. Patent No. 4,281,419, issued August 4, 1981 ("Treace"). 6 U.S. Patent No. 7,922,711 B2, issued April 12, 2011 ("Ranalletta"). 7 U.S. Patent Publication No. 2005/0085904 Al, published April 21, 2005 ("Lemmon"). 3 Appeal2018-003688 Application 13/215,576 discloses the majority of limitations of claim 27, including the adapter and handle, but does not disclose the coloring requirements of claim 27, including a handle grip having the same color as the adapter. Final Act. 4--5. As to the requirement that the handle grip and adapter be the same color, the Examiner found that Henke discloses "a system including a handle having a grip in a certain color, and having an operative member to be coupled with the handle in the same color." Id. at 6 (citing Henke, 1:63-2:6); see also Ans. 3 ("[T]he Henke reference teaches coloring the grip of a tool to then match it with the same color of an operable portion."). Appellants argue that Henke merely discloses colored handles that indicate the characteristics of the tool, such as a putty knife blade. Appeal Br. 7. According to Appellants, "Henke says nothing about how the colored handles interact with other colored parts." Id. We agree with Appellants that the Examiner erred in finding that Henke discloses a handle grip having a color that matches the color of the operative member in Henke. The Examiner relies upon portions of Henke that describe a colored handle having a first colored member that indicates an operating characteristic of an operative member. Henke, 1 :63-2:4; Final Act. 6 (citing Henke, 1:63-2:6). Henke further indicates that the "operating member is connected with the handle and has the operating characteristic as indicated by the color of the first member." Id. at 2:4--6. Henke discloses a putty knife in one embodiment, having a colored handle and a blade that corresponds to the "operating member" referred to in the relevant portions of Henke the Examiner cites. See id. at 3 :44--51. Henke does not describe the operating member or blade as having any color in the cited portions of Henke, much less a color that matches the handle color as the Examiner 4 Appeal2018-003688 Application 13/215,576 found. The fact that the handle color indicates a physical characteristic of the blade, such as its flexibility, does not suggest any blade color, or a relationship between the color of the handle and color of the blade. The Examiner's erroneous finding regarding Henk.e's disclosure formed part of the basis for the Examiner's determination that it would have been obvious to color a grip in Stobie's handle to match the color of Stobie's movable part. See Final Act. 6. 8 The Examiner's analysis does not otherwise reveal any alternative rationale that accounts for the "same color" requirement of claim 27. See id. at 4--7. Accordingly, we do not sustain the rejection of claim 27. Independent Claim 34 Independent claim 34 requires an "adapter having a second color" and "ajar clip having a movement indicator thereon in the second color." Appeal Br. 16 (Claims App.). The specification describes the movement indicator as a blue arrow indicating the direction of rotation of the handle, and a matching blue adapter. Spec. ,r,r 40, 41, 43 (referring to "blue arrow movement indicator 44 of the clip 3 6"), 4 7 (blue adapter and clip), Figs. lOA-lOC. The Examiner found that Stobie discloses the majority of the limitations of claim 34, including the adapter and handle, but does not disclose the coloring requirements of claim 34, including a movement indicator having the same color as the adapter. Final Act. 11-12. As to that limitation, the Examiner found that Ranalletta discloses a "movement 8 The Examiner incorrectly referred to the claimed "movable part" in this determination. See Final Act. 6. Claim 27 requires the handle grip to have the same color as the claimed adapter, which is one part of the movable part. Appeal Br. 14 (Claims App.). 5 Appeal2018-003688 Application 13/215,576 indicator being a rotation arrow (Figure 1; 48), in a color matching that of another part of the mechanism (Figure 1; 30), that indicate the direction of movement of a moveable part coupled to the mechanism (Column 14, Lines 46-63)." Id. at 13. The Examiner determined that it would have been obvious to apply this teaching of Ranalletta to Stobie, and further determined that it would have been obvious to "make the movement indicator the second color" because "the specification of the instant application lacks any criticality of the color of the movement indicator being in the second color." Id. Appellants argue that Ranalletta merely "discloses concentric circles centered on one part to present a target for the user to guide a separate male connector." Appeal Br. 11. According to Appellants, Ranalletta does not disclose matching the color of the directional indicator at all, and instead discloses "color contrasting of one directional arrow of the system." Id. at 12. The Examiner does not respond directly to this argument in the Answer. See Ans. 5---6. We agree with Appellants that the Examiner erred in finding that Ranalletta discloses a movement indicator having a color that matches the color of Ranalletta's film member 30. Final Act. 13. Ranalletta may suggest colored directional indicia 48 (i.e., arrows) when it describes providing the arrows in a "visually distinct manner." See Ranalletta, 14:55- 63. Ranalletta does not, however, describe matching the color of the arrows to film member 30, as the Examiner found. See Final Act. 13. Ranalletta describes planar surface portion 32 and conical surface portion 34 of film member 30 being "visually distinct from each other" and from an adjacent surface, with all three surfaces having different colors "to present a target- 6 Appeal2018-003688 Application 13/215,576 like appearance to a user." Ranalletta, 14:48-55. Ranalletta's description of differing colors between elements of film member 30 and an adjacent surface does not indicate that the color of arrows 48 have the same color as any portion of film member 30. Because the Examiner did not support adequately the finding that Ranalletta discloses a movement indicator and another part having the same color, the Examiner's related obviousness determination lacks an adequate foundation. The Examiner determined that it would have been obvious to "include a movement indicator [ on Stobie' s clip] as in the Ranalletta reference," and the Examiner's mistaken findings regarding Ranalletta's disclosure fatally undermine that determination. See Final Act. 13. The Examiner does find that the specification "lacks any criticality of the color of the movement indicator being in the second color," as further support for the determination that it would have been obvious to make the movement indicator the same color as the adapter. Id. The Examiner does not direct us to, nor are we aware of, case law that suggests that a limitation need not be addressed unless the specification states that it is critical. Even if it were, the finding lacks support because the specification does describe the importance of matching the color of the movement indicator to the adapter. See Spec. ,r,r 43, 47 (describing color coding, including blue arrow matching blue handle and blue adapter, which clarifies the direction of rotation to a user). Based on the foregoing, we do not sustain the rejection of claim 34. Dependent Claims The Examiner's rejections of the dependent claims rely upon the same findings that we discussed above in the context of independent claims 27 and 34, and do not rely on additional references in a manner that remedies 7 Appeal2018-003688 Application 13/215,576 the deficiencies noted above. See Final Act. 7-11, 14--17. Accordingly, we do not sustain the rejection of dependent claims 28-33 and 35--40 for the same reasons discussed above. DECISION We reverse the decision of the Examiner to reject claims 27--40. REVERSED 8 Copy with citationCopy as parenthetical citation