Ex Parte Lalonde

Patent Trial and Appeal BoardMar 28, 2018

13281927 (P.T.A.B. Mar. 28, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE FIRST NAMED INVENTOR 13/281,927 10/26/2011 Jean-Pierre LALONDE 89554 7590 03/30/2018 Christopher & Weisberg, P.A. 1232 N. University Drive Plantation, FL 33322 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. 21819-337U-P0041233.USU1 1885 EXAMINER STICE,PAULAJ ART UNIT PAPER NUMBER 3766 NOTIFICATION DATE DELIVERY MODE 03/30/2018 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): ptomail@cwiplaw.com medtronic_crdm_docketing@cardinal-ip.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte JEAN-PIERRE LALONDE 1 Appeal2017-002664 Application 13/281,927 Technology Center 3700 Before RICHARD M. LEBOVITZ, JOHN G. NEW, and TA WEN CHANG, Administrative Patent Judges. CHANG, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. Â§ 134(a) involving claims to a tissue puncturing device, which have been rejected as anticipated or obvious. We have jurisdiction under 35 U.S.C. Â§ 6(b ). We REVERSE. 1 Appellant identifies the Real Party in Interest as Medtronic CryoCath LP. (Appeal Br. 1.) Appeal2017-002664 Application 13/281,927 STATEMENT OF THE CASE The Specification teaches that, in cardiac procedures performed in the left atrium of the heart, a device may be advanced through a patient's femoral vein to the right atrium of the heart before creating a puncture in the transseptal wall to access the left side of the heart. (Spec. i-f 4.) The Specification further teaches that "anchoring ... the puncturing device against the tissue may be critical to the successful treatment of ... cardiac conditions that involve transseptal puncture," because various factors including "beating of the heart, slipperiness of the myocardium, and irregularities in the thickness of the septum can contribute to the difficulty in ... accurately puncturing the septum without causing injury." (Id. i-f 5.) The Specification explains that such "[ s ]tabilization and/ or anchoring of the cardiac tissue has been performed using devices that apply mechanical or compression force, such as clamps, or devices that apply negative pressure (i.e. suction) to the tissue," but that "these devices are sometimes significantly invasive" and "may present excess force or trauma to the engaged tissue, causing unwanted injury to the patient." (Id. i-f 6.) In contrast, the Specification states that "[t]he present invention provides systems and methods of use thereof for anchoring tissue using cryoadhesion while puncturing the tissue during various medical procedures." (Id. i-f 18.) Claims 1-9, 11-14, 25, and 26 are on appeal. Claim 1, the only independent claim, is illustrative and reproduced below: 1. A tissue puncturing device, comprising: an elongate body defining a longitudinal axis, a proximal portion, a distal portion, a fluid flow path, and a lumen being symmetrically disposed within the elongate body and being coaxial with the longitudinal axis; 2 Appeal2017-002664 Application 13/281,927 a cryoadhesive segment coupled to the distal portion of the elongate body and in thermal communication with the fluid flow path, the cryoadhesive segment defining a distal face that is coaxial with the lumen; and a puncturing element movably disposed within the lumen. (Appeal Br. 12 (Claims App.).) The Examiner rejects claims 1, 3, 11, 12, 25, and 26 under pre-AIA 35 U.S.C. Â§ 102(e) as being anticipated by Thompson-Nauman. 2 (Ans. 2.) The Examiner rejects claims 2, 4---6, 8, and 9 under pre-AIA 35 U.S.C. Â§ 103(a) as being unpatentable over Thompson-Nauman and Abboud. 3 (Id.) The Examiner rejects claims 7 and 14 under pre-AIA 35 U.S.C. Â§ 103(a) as being unpatentable over Thompson-Nauman, Abboud, and Brannan. 4 (Id.) The Examiner rejects claim 13 under pre-AIA 35 U.S.C. Â§ 103(a) as being unpatentable over Thompson-Nauman and Kuck. 5 (Id.) DISCUSSION Issue The same issue is dispositive for all of the rejections; we, therefore, discuss the rejections together. The Examiner finds that Thomson-Nauman discloses each element of claims 1, 3, 11, 12, 25, and 26. (Final Act. i-f 7.) Appellant contends that Thompson-Nauman does not disclose "a lumen being symmetrically disposed within the elongate[d] body and being coaxial with the 2 Thompson-Nauman et al., US 8,346,373 B2, issued Jan. 1, 2013. 3 Abboud et al., US 7,625,369 B2, issued Dec. 1, 2009. 4 Brannan, US 2012/0259324 Al, published Oct. 11, 2012. 5 Kuck et al., US 2010/0198203 Al, published Aug. 5, 2010. 3 Appeal2017-002664 Application 13/281,927 longitudinal axis," as recited in claim 1. (Appeal Br. 6 (internal quotation marks omitted).) The issue with respect to the rejections is whether Thompson-Nauman teaches the limitation relating to "a lumen being symmetrically disposed within the elongate[d] body and being coaxial with the longitudinal axis." Analysis Figures 1-5 and 13 of Thompson-Nauman are excerpted below: FIG. 2 FIG.5 Thompson-Nauman's Figure 1 depicts an oblique view of Thompson- Nauman's catheter with an instrument 38 in the catheter; Figures 2 and 5 depict views of the proximal and distal ends, respectively, of the catheter in Figure 1; Figures 3 and 4 depict oblique views of the elongated tube and cryoadhesion member, respectively, in Figure 1; and Figure 13 depicts "a conceptual illustration of a catheter, an instrument, the pericardia! sac (cross- section) and the heart (cross-section) where the instrument is within the 4 Appeal2017-002664 Application 13/281,927 catheter and ... protrudes through the pericardia! sac into the anatomical space." (Thompson-Nauman 3:34--42, 59---63.) The Examiner finds that Thompson-Nauman discloses a tissue puncturing device (catheter 30) having a lumen, formed by the walls 22 of the elongated body 70, that is symmetrically disposed and coaxial with the defined longitudinal axis of the elongated body. (Final Act. i-f 7.) Appellant contends that a lumen is by definition hollow and that catheter 30 "is solid except for the 'delivery lumen 28' and 'coolant lumens 34, 36. "' (Appeal Br. 7.) In response, the Examiner contends that "a lumen can be both filled and hollow" and "disagrees with the characterization that lumens cannot be filled or else they lose their status as a lumen." (Ans. 3.) We find Appellant to have the better argument. The claim requires a symmetrically disposed lumen within the elongate body that is coaxial with it. While we agree (and Appellant does not appear to dispute) that a lumen does not lose its status as a lumen merely because it is "filled" with liquid or has an instrument disposed within it, such a "filled" lumen is not the same as a solid body because, for instance, the liquid or the instrument is separate from and may be removed from the lumen. (Reply Br. 5---6.) The Examiner thus fails to address the gravamen of Appellant's argument, which is that, other than delivery lumen 28 and coolant lumens 34 and 36, which as discussed below are not lumens that are "symmetrically disposed" within the elongated body 70 or coaxial with its longitudinal axis, catheter 30 defines a solid body. 6 6 We express no opinion as to whether catheter 30 in fact defines a solid body containing only lumens 28, 34, and 36. However, the Examiner has neither cited evidence nor persuasively argued that walls 22 define a hollow space (i.e., a lumen) and thus fails to establish a prima facie case of 5 Appeal2017-002664 Application 13/281,927 To the extent the Examiner is contending that a lumen may be a solid body, we are likewise not persuaded. (Final Act. 2 ("The fact that the lumen defined by walls 22 of the Thompson-Nauman disclosure is solid does not negate the lumen from meeting the requirements of what a lumen is defined as.").) The plain and ordinary meaning of "lumen" is a "cavity" or "bore," which are hollow rather than solid, 7 and the Examiner has cited no evidence that suggests the broadest reasonable interpretation of "lumen" in light of the Specification encompasses a solid body. Finally, the Examiner contends that, regardless of whether the walls 22 of the elongated body 70 defines a "lumen," delivery lumen 28 and coolant lumen 34, which Appellant does not dispute are lumens, would meet the lumen limitation of claim 1. (Ans. 4.) In particular, the Examiner finds: Even if lumen 28 or 34 is discussed with regard to this claim language the lumens 28/34 share an axis with the longitudinal axis (if the longitudinal axis i[ s] drawn down the center of [F]igure 2 of Thompson-Nauman). Further to be symmetrically disposed would indicate that the lumen has symmetry which anticipation. We also note the Examiner's suggestion in an Interview Summary that, even if Appellants were to amend the claims to only include "hollow" lumens, the combination of newly reviewed prior art Wittenberger (Wittenberger et al., US 2012/0029494 Al, published Feb. 2, 2012) and Satake (Satake, US 6,491,710 B2, issued Dec. 10, 2002) would render the amended claims obvious. (Jan. 25, 2016 Examiner-Initiated Interview Summary 1.) Because the Examiner has not made a rejection of the claims on appeal over Wittenberger and Satake, and such a rejection is therefore not on appeal before us, we do not address these prior art references and leave them to the Examiner's consideration in the first instance in the event of further prosecution. 7 See, e.g., "lumen." MERRIAM-WEBSTER, https://www.merriam- webster.com/ dictionary/lumen (last visited March 6, 2018) (defining lumen as "the cavity of a tubular organ or part" or "the bore of a tube"). 6 Appeal2017-002664 Application 13/281,927 would be defined as something having two sides or halves that are the same[,] http://www.merriam-webster.com/diclionarv /svmmetry. which is clearly the case of these lumens. (Ans. 4.) We are not persuaded. The claim requires that the lumen in question be coaxial with the longitudinal axis of the elongated body. While lumens 28 and 34 have longitudinal axes that are parallel to the longitudinal axis of the elongated body 70, they do not share the same longitudinal axis (i.e., are not coaxial). 8 In other words, we interpret "coaxial" to require the lumen to be aligned along the same longitudinal axis as the elongate body and to be concentric with it. 9 Accordingly, we reverse the Examiner's rejection of claim 1 as anticipated by Thompson-Nauman. We reverse the anticipation rejection of claims 3, 11, 12, 25, and 26, which depend directly or indirectly from claim 1, for the same reasons. Finally, the Examiner cites Abboud, Brannan, and Kuck only for the additional limitations in dependent claims and does not suggest that they cure the deficiencies in Thompson-Nauman identified by the Appellant. Accordingly, we also reverse the obviousness rejection of claims 2, 4--9, 13, and 14, which depend directly or indirectly from claim 1, for the reasons discussed above. 8 To the extent the Examiner is contending that a line could be drawn down the center of Figure 2 that would bisect all three of lumens 28 and 34 and elongated body 70, the Examiner has not explained how such an "axis" would be considered the longitudinal axis. 9 See, e.g., "coaxial." MERRIAM-WEBSTER, https://www.merriam- webster.com/ dictionary/ coaxial (last visited March 26, 2018) (defining coaxial as "having coincident axes" or "mounted on concentric shafts"). 7 Appeal2017-002664 Application 13/281,927 SUMMARY For the reasons above, we reverse the Examiner's decision rejecting claims 1-9, 11-14, 25, and 26. REVERSED 8