LOMA VISTA MEDICAL, INC.

Patent Trials and Appeals Board

Mar 2, 2022

2021004031 (P.T.A.B. Mar. 2, 2022)

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. 15/915,549 03/08/2018 Alexander Q. TILSON P-21305.US04CON 4070 79990 7590 03/02/2022 Andrew D. Dorisio 300 West Vine Street Suite 1700 Lexington, KY 40507 EXAMINER GRAY, PHILLIP A ART UNIT PAPER NUMBER 3783 NOTIFICATION DATE DELIVERY MODE 03/02/2022 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): dwpatents@dickinson-wright.com ip.docket@bd.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte ALEXANDER Q. TILSON, PAUL J. DREYER, MITCHELL C. BARHAM, MARK C. SCHEEFF, CHARLES S. LOVE, GARRETT J. GOMES, and JONATHAN KURNIAWAN Appeal 2021-004031 Application 15/915,549 Technology Center 3700 Before BENJAMIN D. M. WOOD, BRETT C. MARTIN, and JEREMY M. PLENZLER, Administrative Patent Judges. PLENZLER, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the Examiner’s decision to reject claims 1-22. We have jurisdiction under 35 U.S.C. § 6(b). We REVERSE. 1 We use the word Appellant to refer to “applicant” as defined in 37 C.F.R. § 1.42(a). Appellant identifies the real party in interest as Loma Vista Medical, Inc. Appeal Br. 2. Appeal 2021-004031 Application 15/915,549 2 CLAIMED SUBJECT MATTER The claims relate to an inflatable medical device. Claim 1, 16, and 19, reproduced below with emphases added, are illustrative of the claimed subject matter: 1. An apparatus for performing a medical procedure, comprising: a non-compliant shell; and a plurality of inflatable balloons arranged at least partially inside of the non-compliant shell, wherein the inflatable balloons are fixed in the non-compliant shell; and a fluid passage located radially inwardly of the plurality of balloons; wherein the shell includes a proximal opening and a distal opening for perfusing a flow of fluid through the shell. 16. An apparatus for performing a medical procedure, comprising: an uninflatable shell comprising at least one inelastic fiber; and a plurality of inflatable balloons arranged at least partially inside of the shell. 19. An apparatus for performing a medical procedure, comprising: a perfusion catheter including a non-compliant inflatable structure at a distal end portion thereof, the non-compliant inflatable structure comprising a shell adapted to perfuse fluid therethrough and a plurality of inflatable balloons fixed at least partially inside of the shell, and a fluid passage located radially inwardly of the plurality of inflatable balloons. Appeal 2021-004031 Application 15/915,549 3 REFERENCES The prior art relied upon by the Examiner is: Name Reference Date Dunham US 5,797,948 Aug. 25, 1998 Davies US 2008/0183132 A1 July 31, 2008 REJECTION Claims 1-22 are rejected under 35 U.S.C. § 103(a) as being unpatentable over Dunham and Davies. OPINION Claims 1, 16, and 19 are independent. Each claim requires some sort of arrangement where its shell cannot hold fluid. Claim 1 requires that “the shell includes a proximal opening and a distal opening for perfusing a flow of fluid through the shell.” Claim 16 requires “an uninflatable shell.” Claim 19 requires “a shell adapted to perfuse fluid therethrough.” Appellant identifies the openings in the shell as shell apertures 714 and the uninflatable shell as shell 678. Appeal Br. 2. We do not see where the Specification employs the term “uninflatable,” but, consistent with our understanding above, a shell with openings preventing it from holding air or other fluids is uninflatable. This is also consistent with Appellant’s Specification. Appellant’s Specification explains, for example, that “Figure 2B shows a shell 678 with shell apertures 714,” which “may penetrate the entire wall of the shell 678.” Spec. ¶ 115. “Shell apertures 714 may release internal pressure from the shell 678 and may allow materials such as blood or air to cross the plane of the shell wall 684” and “can be in fluid communication with the inside and outside of the shell 678.” Id. Appeal 2021-004031 Application 15/915,549 4 In the rejection of claim 1, the Examiner finds that Dunham discloses an apparatus for performing a medical procedure, (figure 6) comprising: a non-compliant shell (120); and a plurality of inflatable balloons (132/138[)] arranged at least partially inside of the non-compliant shell, wherein the inflatable balloons are fixed in the non-compliant shell; and a fluid passage (near 160) located radially inwardly of the plurality of balloons. Final Act. 2 (emphasis added). The Examiner finds that “Dunham discloses the claimed invention except for the shell with a fiber or wire.” Id. Claim 1, however, does not require its shell to have a fiber or wire. Nevertheless, the Examiner finds that “Davies teaches that it is known to use shell with fiber or wire as set forth in para [0006] to provide a means to strengthen the balloon and prevent collapse.” Final Act. 2. The Examiner reasons that [i]t would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Dunham with shell with fiber or wire as taught by Davies, since such a modification would provide the system with shell with fiber or wire for providing a means to strengthen the balloon and prevent collapse. Id. Although, as noted above, claim 1 does not require a fiber or wire, the rejection requires the modification based on Davies for claim 1’s recitation that “the shell includes a proximal opening and a distal opening for perfusing a flow of fluid through the shell.” Id. at 3. The Examiner finds that Davies teaches the openings recited in claim 1. Specifically, the Examiner finds that “[c]oncerning the . . . language of the ‘shell includes a proximal opening and a distal Appeal 2021-004031 Application 15/915,549 5 opening for perfusing a flow of fluid through the shell[’] see Davies figure below.” Final Act. 3. The Examiner’s annotated figure is reproduced below. The Examiner’s annotated figure is Figure 5a from Davies, which “show[s] a method of making a non-compliant medical balloon having a braided fiber reinforcement layer” (Davies ¶ 30), along with the Examiner’s annotations indicating the portions considered the shell and the openings. Id. The Examiner’s rejection is somewhat unclear. It appears that the Examiner is proposing placing braided fabric layer 510 from Davies on Dunham’s outer balloon 120. In this arrangement, however, Appellant correctly notes that “it then lacks the alleged openings identified by the Examiner as allegedly perfusing fluid ‘through the shell’ as the claim language requires.” Appeal Br. 3. Dunham describes its balloon 120 as a non-compliant inflatable structure. Dunham, 2:39-42, 3:44-46, 3:60-62, 5:33-34.2 That is, it is designed to hold a fluid. Indeed, every claim in Dunham also requires that its outer balloon is inflatable. See id. at 7:19, 7:49, 8:12, 8:36, 8:63, 10:1. 2 The majority of Dunham’s description regarding its outer balloon is in reference to outer balloon 20, but that description applies to balloon 120 as well. See Dunham, 5:42-47. Appeal 2021-004031 Application 15/915,549 6 Dunham even specifies that its outer balloon 120 is intended to apply outward compression. See id. at 5:33-34. The Examiner fails to explain how Dunham’s outer balloon “includes a proximal opening and a distal opening for perfusing a flow of fluid through the shell” as recited in claim 1. Perhaps the Examiner’s rejection intends that braided fabric layer 510 from Davies replaces Dunham’s outer balloon, rather than being placed on Dunham’s outer balloon. But even if we read the rejection in that manner, it stills suffers from a number of issues. It is unclear how such an arrangement would provide the benefit of preventing collapse asserted by the Examiner. For example, Davies is concerned with “prevent[ing] excessive expansion of the base balloon when the base balloon is internally pressurized.” Davies ¶ 12. In the Example cited by the Examiner, “the braided fiber sleeve 510 is pulled over the inflated balloon 502, expanding over the contours of the balloon (FIG. 5b).” Id. ¶ 65. Although the Examiner cites paragraph 6 from Davies to support the rationale, that paragraph, too, addresses preventing expansion rather than collapse. Further, such a modification eliminates the purpose of Dunham’s outer balloon. With an arrangement where braided fabric layer 510 from Davies replaces Dunham’s outer balloon, there would no longer be the ability for Dunham’s outer balloon to apply the desired outward pressure noted above. For at least these reasons, we do not sustain the Examiner’s decision to reject claim 1. The rejections of claims 16 and 19 suffer from the same deficiencies, whether the rejection adds braided fabric layer 510 from Davies to Dunham’s outer balloon 120 or replaces Dunham’s outer balloon 120. Appeal 2021-004031 Application 15/915,549 7 The stated bases for the rejection of dependent claims 2-15, 17, 18, and 20-22 do not cure these deficiencies. CONCLUSION The Examiner’s rejection is reversed. DECISION SUMMARY In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1-22 103(a) Dunham, Davies 1-22 REVERSED