William S. Suhr

Patent Trials and Appeals BoardMar 30, 2020

13579696 - (D) (P.T.A.B. Mar. 30, 2020)

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. 13/579,696 11/02/2012 William S. Suhr SUHR-P008 1768 7590 03/30/2020 Henry C. Query, Jr. 504 S. Pierce Avenue Wheaton, IL 60187 EXAMINER KNAUSS, CHRISTIAN D ART UNIT PAPER NUMBER 3771 MAIL DATE DELIVERY MODE 03/30/2020 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 WILLIAM S. SUHR ____________ Appeal 2019-002723 Application 13/579,696 Technology Center 3700 ____________ Before JENNIFER D. BAHR, MICHAEL L. HOELTER, and MICHELLE R. OSINSKI, Administrative Patent Judges. OSINSKI, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Appellant1 appeals under 35 U.S.C. § 134(a) from the Examiner’s decision rejecting claims 1, 6–8, and 13.2 We have jurisdiction over the appeal under 35 U.S.C. § 6(b). 1 We use the term “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42. Appellant identifies the real party in interest as Dr. William S. Suhr. Appeal Br. 2. 2 Claims 2–5, 9–12, and 14–16 are cancelled. Appeal Br. 19–20 (Claims App.). “Claims 17–24 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.” Non-Final Act. 13. Appeal 2019-002723 Application 13/579,696 2 We AFFIRM. THE CLAIMED SUBJECT MATTER Claims 1 and 13 are independent. Claim 1 is reproduced below. 1. A balloon catheter for use in treating a condition of a vessel occurring near a bifurcation defined by the intersection of a main vessel with a side branch vessel, the balloon catheter comprising: a shaft which includes a proximal end, a distal end and a side surface; a single guide wire lumen which extends longitudinally through the shaft; a distal port which extends from the guide wire lumen through the distal end of the shaft; a side port which extends transversely from the guide wire lumen through the side surface of the shaft; and a balloon which is formed separately from the shaft, the balloon being mounted on the shaft and comprising a first end which is sealed to the shaft proximally of the side port, a second end which is sealed to the shaft distally of the side port, an aperture which is aligned with the side port, and a longitudinal segment which extends from the first end to the second end and is entirely sealed to the shaft, said aperture being located in said longitudinal segment such that a portion of the balloon surrounding the aperture is sealed to the shaft around the side port; wherein the balloon is configured such that, in an inflated condition the balloon comprises a longitudinal centerline which is radially offset from a longitudinal centerline of the shaft; and wherein in use of the balloon catheter a proximal end of a first guide wire which is pre-positioned in the main vessel is inserted into the distal port and threaded through the guide wire lumen toward the proximal end of the shaft and a proximal end of a second guide wire which is pre-positioned in the side branch vessel is inserted into the side port and threaded through the guide wire lumen toward the proximal end of the shaft; whereby the balloon is guided to the bifurcation on the first and second guide wires. Appeal 2019-002723 Application 13/579,696 3 EVIDENCE The Examiner relied on the following evidence in rejecting the claims on appeal: Name Reference Date Cragg US 5,795,331 Aug. 18, 1998 Loaldi US 2003/0187494 A1 Oct. 2, 2003 Suhr US 2004/0015231 A1 Jan. 22, 2004 REJECTIONS I. Claims 1, 7, 8, and 13 stand rejected under 35 U.S.C. § 102(b) as anticipated by Suhr. Non-Final Act. 3–6. II. Claims 1, 7, 8, and 13 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Loaldi and Cragg. Id. at 6–11. III. Claim 6 stands rejected under 35 U.S.C. § 103(a) as unpatentable over Loaldi, Cragg, and Suhr. Id. at 11–13. OPINION Rejection I The Examiner finds that Suhr discloses, among other things, balloon 20 comprising first end 16 sealed to shaft 34 proximally of side port 30, second end 18 sealed to shaft 34 distally of side port 30, and a longitudinal segment which extends from first end 16 to second end 18 and is entirely sealed to the shaft. Non-Final Act. 3. The Examiner also finds that Suhr discloses, among other things, that when balloon 20 is in an inflated condition, it comprises a longitudinal centerline that is radially offset from a longitudinal centerline of shaft 34. Id. at 4. The Examiner includes an annotated reproduction of a portion of Figure 2 of Suhr to Appeal 2019-002723 Application 13/579,696 4 illustrate what the Examiner considers to be first end 16, second end 18, and the longitudinal segment of the balloon, as set forth in the claims. Id. at 4. Both Suhr’s Figure 2 and the Examiner’s annotated version of a portion of Suhr’s Figure 2 are reproduced below. Figure 2 of Suhr Suhr’s Figure 2 depicts a longitudinal cross sectional view of balloon catheter 10' in its inflated condition, with balloon catheter 10' including balloon head 20 that includes first balloon portion 16, second balloon portion 18, proximal end 22, distal end 24, and midpoint 26. Suhr ¶¶ 10, 19. Examiner-annotated version of Figure 2 of Suhr Appeal 2019-002723 Application 13/579,696 5 The Examiner’s annotated version depicts only a central portion of Suhr’s Figure 2 and includes annotations indicating what the Examiner determines to be the “longitudinal segment,” “first end proximal seal,” and “second end distal seal” of balloon 20. Non-Final Act. 4. The Examiner takes the position that “the claim does not specify the locations of the first and second ends of the balloon” and “[t]he claim does not specify that the first end of the balloon is sealed proximally of the side port at the proximal end of the shaft and distally of the side port at the distal end of the shaft.” Id. at 5 (boldface and underlining omitted). The Examiner also takes the position that “the centerline of portion 26 of the balloon is radially offset from the centerline of the shaft.” Id. at 4. Appellant argues that “the Examiner’s interpretations of the terms ‘first end’ and ‘second end’ are unreasonable in light of the specification as it would be interpreted by one of ordinary skill in the art.” Appeal Br. 10– 11. According to Appellant, “[t]he plain and ordinary meaning of the term ‘end’ is ‘the extreme or last part lengthwise.’” Id. at 11 (citing Merriam- Webster Dictionary). Appellant also points to Figure 1 of the Specification in which “the first end 26 of the balloon 12 is located at one extreme of the balloon and the second end 28 is located at the opposite extreme of the balloon” in support of its proffered interpretation. Id. (citing Spec. Fig. 1). Appellant argues that in accordance with the proper interpretation of “end,” “the ‘first end’ of Suhr’s balloon 20 is not the entire first portion 16 of the . . . balloon” and “the second portion 18 of Suhr’s balloon 20 is not located at the other longitudinal extreme of the balloon.” Id. at 12. In sum, Appellant argues that “[u]sing the proper interpretations of the terms ‘first end’ and ‘second end’, one can clearly see that Suhr does not disclose a Appeal 2019-002723 Application 13/579,696 6 balloon having a longitudinal segment which extends from the first end of the balloon to the second end of the balloon and is entirely sealed to the shaft.” Id. at 12–13. The Examiner responds that “[r]eading ‘the opposite longitudinal extremes of the balloon’ into the claims for the terms ‘the first end’ and ‘the second end’ is not giving the term ‘end’ its broadest reasonable interpretation.” Ans. 4. The Examiner counters that “[a] more appropriate interpretation of the term ‘end’ is ‘a part or place at or adjacent to an extremity.’” Id. (quoting Dictionary.com). The Examiner takes the position that “the extreme points on the balloon are depicted at 22 and 24[,] and portions 16 and 18, interpreted by the Examiner as the first end and the second end, are parts of the balloon adjacent to those extremities” and “longitudinal segment (at 26) . . . extends from the first end to the second end.” Id. at 4–5 (citing Suhr Fig. 2, ¶ 19). During patent prosecution, the USPTO gives claims their broadest reasonable interpretation consistent with the Specification, reading claim language in light of the Specification as it would be interpreted by one of ordinary skill in the art. In re Am. Acad. of Sci. Tech Ctr., 367 F.3d 1359, 1364 (Fed. Cir. 2004). Even assuming arguendo that the Examiner’s proffered interpretation is the broadest reasonable interpretation, we disagree with the Examiner that the entirety of portions 16, 18 can each reasonably be considered an “end” of balloon 20 by virtue of being adjacent to extremities 22, 24, respectively, of balloon 20. Without ascribing any particular cut off point for the “part” of balloon 20 that can be considered “adjacent” an extremity in accordance with the Examiner’s interpretation, in our view it is unreasonable to consider the Examiner-identified sections of balloon Appeal 2019-002723 Application 13/579,696 7 portions 16, 18 that are actually farthest from extremities 22, 24 of balloon 20 and instead most near midpoint 26 of balloon 20 to be part of an “end” of balloon 20. Because it is unreasonable to consider the Examiner-identified “first end proximal seal” and “second end distal seal” (Non-Final Act. 4) to be located at “ends” of the balloon, it is also unreasonable to consider the segment that extends between them to be the claimed “longitudinal segment which extends from the first end to the second end and is entirely sealed to the shaft,” as claimed. We agree with Appellant that “Suhr does not disclose a balloon having a longitudinal segment which extends from the first end of the balloon to the second end of the balloon and is entirely sealed to the shaft.” Appeal Br. 12–13. For the foregoing reasons, Appellant apprises us of error in the Examiner’s finding that Suhr discloses all of the limitations of independent claims 1 and 13. We do not sustain the rejection of claims 1 and 13, nor claims 7 and 8 which depend therefrom, under 35 U.S.C. § 102(b) as anticipated by Suhr. Rejection II Appellant presents arguments for independent claims 1 and 13 together and relies on the same arguments for dependent claims 7 and 8. Appeal Br. 13–17. We select claim 1 as representative of the issues that Appellant presents in the appeal, and claims 7, 8, and 13 stand or fall therewith. See 37 C.F.R. § 41.37(c)(1)(iv). The Examiner finds that Loaldi teaches many of the limitations of independent claim 1, but acknowledges that Appeal 2019-002723 Application 13/579,696 8 Loaldi fails to disclose that the balloon is formed separately from the shaft, the first end of the balloon sealed to the shaft proximally of the side port, the second end sealed to the shaft distally of the side port, an aperture formed in the balloon is aligned with the side port, and a longitudinal segment which extends from the first end to the second end and is entirely sealed to the shaft, said aperture being located in said longitudinal segment such that a portion of the balloon surrounding the aperture is sealed to the shaft around the side port. Non-Final Act. 6–7 (citing Loaldi Figs. 33, 34, 37–40, 56). The Examiner turns to Cragg, finding that Cragg teaches a balloon catheter comprising balloon 52 formed separately of shaft 13, with balloon 52 including first end 54 sealed to shaft 13 proximally of side port 60, second end 55 sealed to shaft 13 distally of side port 60, an aperture aligned with side port 60, and a longitudinal segment that extends from first end 54 to second end 55 and is entirely sealed to shaft 13. Id. at 7–8 (citing Cragg Figs. 7, 8C, 17, 18; 12:25–46). The Examiner concludes that it would have been obvious to modify the balloon catheter disclosed by Loaldi such that th[e] balloon is formed separately from the shaft, the first end of the balloon sealed to the shaft proximally of the side port, the second end sealed to the shaft distally of the side port, . . . and a longitudinal segment which extends from the first end to the second end and is entirely sealed to the shaft . . . as taught by Cragg . . . because applying a known technique (the manufacturing process of the balloon catheter taught by Cragg) to a known device (the balloon catheter disclosed by Loaldi) to yield predictable results (forming a balloon having a longitudinal centerline that is offset from the longitudinal centerline of the catheter shaft, wherein a first end of the balloon is sealed to the shaft proximally of the side port, a second end is sealed to the shaft distally of the side port, . . . and a longitudinal segment which extends from the first end to the second end and is entirely sealed to the shaft . . . ) would have been recognized by one having ordinary skill in the art at the time the invention was made. Appeal 2019-002723 Application 13/579,696 9 Non-Final Act. 8–9. Appellant argues that “Cragg does not disclose a balloon catheter in which the balloon has a longitudinal segment which extends from the first end of the balloon to the second end of the balloon and is entirely sealed to the shaft.” Appeal Br. 15. More particularly, Appellant asserts that “Cragg’s balloon catheter includes a pair of radiopaque markers 15, 17 which are mounted concentrically on the shaft 13 on opposite sides of the side port 60” and “prevent the longitudinal segment from being entirely sealed to the shaft between the first and second ends 54, 56.” Id. According to Appellant, “instead of providing a balloon catheter in which the entire longitudinal segment of the balloon is sealed to the shaft, Cragg teaches that only certain portions of the longitudinal segment are sealed to the shaft.” Reply Br. 5. The Examiner responds that “[t]he Examiner is relying on Cragg as a teaching reference to teach a sealed attachment configuration between a balloon and a shaft that was known in the art at the time the invention was made” and “the Examiner did not propose modifying Loaldi to include radiopaque markers on the surface of the shaft.” Ans. 7. Cragg discloses an embodiment in which “a minor circumferential interior section of the tubular balloon [52'] i[s] adhered along the outer surface of tube 13 (FIG. 8C) so that the balloon 52' only inflates around the major circumference of the distal end segment 16” of catheter body 12, and “[t]he delivery exit ports 60 and 60' . . . are . . made . . . through the adhered balloon wall 52' and outer tube 13.” Cragg 12:33–42. We agree with the Examiner that, applying such a teaching to the device of Loaldi (Figs. 33, 34, 37–40, 56) would result in the modified Loaldi device including a balloon having a longitudinal segment extending from a first end to a second Appeal 2019-002723 Application 13/579,696 10 end of a balloon that is entirely sealed to the shaft. This is because Loaldi lacks any such structure, such as radiopaque markers, that would be disposed between the longitudinal segment of balloon 5 and shaft 2. Moreover, Appellant does not offer any evidence to support the position that “the radiopaque markers 15, 17 create weak points in the seal between the longitudinal segment and the shaft 13” due to radiopaque markers 15, 17 preventing the longitudinal segment from being entirely sealed to the shaft (Appeal Br. 15). In this regard, Appellant’s assertion amounts to attorney argument unsupported by evidence, and, thus, is entitled to little, if any, weight. In re Geisler, 116 F.3d 1465, 1470 (Fed. Cir. 1997); see also In re Pearson, 494 F.2d 1399, 1405 (CCPA 1974) (An attorney’s arguments in a brief cannot take the place of evidence.). Appellant also argues that modifying Loaldi so (i) as to form its balloon 5 separately from its shaft 2, (ii) that its balloon 5 includes a first end which is sealed to shaft 2 proximally of side port 15, (iii) that its balloon 5 includes a second end which is sealed to shaft 2 distally of side port 15, and (iv) that its balloon 5 includes a longitudinal segment which extends from the first end to the second end and is entirely sealed to shaft 2 “would render Loaldi inoperable for its intended purpose.” Appeal Br. 16. More particularly, Appellant argues that “if the balloon [5] were to be formed as a separate member having first and second ends that are sealed to the shaft 2, the interior volume of the balloon [5] would be isolated from the inflation lumen 18 by the shaft 2 itself” and “the balloon could not be inflated, thus rendering the modified balloon catheter inoperable for its intended purpose.” Id. at 16–17. Appeal 2019-002723 Application 13/579,696 11 The Examiner responds that “one having ordinary skill in the art would recognize that modifying a balloon catheter having a separate balloon sealed to the catheter shaft would require alternate inflation means than a balloon that is formed integrally with the shaft.” Ans. 7–8. More particularly, the Examiner points to Cragg’s teaching “that the balloon catheter comprises an inflation/deflation lumen (18) with inflation/deflation holes (58) in fluid communication with the interior of the balloon to inflate/deflate the balloon.” Id. at 8 (citing Cragg Figs. 7, 8C, 18). Appellant replies that “the Examiner appears to be relying on hindsight to rectify the failings of the proposed modification” and that “[i]f one of ordinary skill in the art had the benefit of the present application, that person could certainly modify Loaldi’s balloon to make [Appellant’s] claimed invention[, but] this would be improper.” Reply Br. 6. Appellant’s argument is unavailing because Appellant does not point to any knowledge relied on by the Examiner that was gleaned only from Appellant’s disclosure and that was not otherwise within the level of ordinary skill in the art at the time of the invention, thereby failing to support Appellant’s hindsight assertion. See In re McLaughlin, 443 F.2d 1392, 1395 (CCPA 1971) (“Any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning, but so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made and does not include knowledge gleaned only from applicant’s disclosure, such a reconstruction is proper.”). Here, Cragg itself provides an example of an alternate inflation means for a balloon catheter having a separate balloon sealed to the catheter shaft that utilizes Appeal 2019-002723 Application 13/579,696 12 openings through the outer wall of the catheter body to the interior space of the balloon. See, e.g., Cragg 9:39–50. Appellant also argues that “the Examiner has provided no support for the proposition that the person of ordinary skill in the art would have a valid reason to first, form Loaldi’s balloon as a separate component and second, provide the shaft with apertures to connect the inflation lumen with the interior of the balloon.” Reply Br. 6. According to Appellant, “[f]aced with such a prospect, the person of ordinary skill in the art would be more inclined to just leave Loaldi’s balloon the way it is.” Id. The Supreme Court has rejected a rigid teaching, suggestion, or motivation requirement to combine known elements in order to show obviousness. See In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006) (cited with approval in KSR Int’l Co. v. Teleflex, Inc., 550 U.S. 398, 418 (2007) (“[R]ejections on obviousness grounds . . . [require] some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.”). In this case, the modification to Loaldi’s balloon catheter proposed by the Examiner is based on the application of “a known technique (the manufacturing process of the balloon catheter taught by Cragg) to a known device (the balloon catheter disclosed by Loaldi) to yield predictable results (forming a balloon having a longitudinal centerline that is offset from the longitudinal centerline of the catheter shaft . . .).” Non-Final Act. 8. Thus, the Examiner articulates reasoning having rational underpinnings, and Appellant does not sufficiently identify any flaw in the Examiner’s reasoning. For the foregoing reasons, Appellant does not apprise us of error in the Examiner’s conclusion that the combination of Loaldi and Cragg renders obvious the subject matter of independent claim 1. We sustain the rejection Appeal 2019-002723 Application 13/579,696 13 of claim 1, and claims 7, 8, and 13 falling therewith, under 35 U.S.C. § 103 as unpatentable over Loaldi and Cragg. Rejection III Appellant relies on the same arguments and reasoning we found unpersuasive in connection with independent claim 1 as the basis for seeking reversal of the rejection of claim 6. Appeal Br. 17. Accordingly, for the same reasons discussed above in connection with the rejection of claim 1, we also sustain the rejection of claim 6 under 35 U.S.C. § 103(a) as unpatentable over Loaldi, Cragg, and Suhr. CONCLUSION In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1, 7, 8, 13 102(b) Suhr 1, 7, 8, 13 1, 7, 8, 13 103(a) Loaldi, Cragg 1, 7, 8, 13 6 103(a) Loaldi, Cragg, Suhr 6 Overall Outcome 1, 6–8, 13 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)(1)(iv). AFFIRMED