SMITHS MEDICAL INTERNATIONAL LIMITED

Patent Trials and Appeals BoardOct 26, 2021

2021002757 (P.T.A.B. Oct. 26, 2021)

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. 15/112,785 07/20/2016 Steve Chambers 0119/0144 6828 135866 7590 10/26/2021 LAW OFFICE OF LOUIS WOO 717 NORTH FAYETTE STREET ALEXANDRIA, VA 22314 EXAMINER GALLEGOS, CANA A ART UNIT PAPER NUMBER 3785 MAIL DATE DELIVERY MODE 10/26/2021 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 STEVE CHAMBERS ____________ Appeal 2021-002757 Application 15/112,785 Technology Center 3700 ____________ Before BIBHU R. MOHANTY, CYNTHIA L. MURPHY, BRADLEY B. BAYAT, Administrative Patent Judges. MOHANTY, 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 9–17. We have jurisdiction under 35 U.S.C. § 6(b). SUMMARY OF THE DECISION 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 Smiths Medical International Limited (Appeal Br. 3). Appeal 2021-002757 Application 15/112,785 2 CLAIMED SUBJECT MATTER The Appellant’s claimed invention relates to tracheal tubes with a shaft and an inflatable sealing cuff on its outside towards its patient end (Spec. 1, ll. 2, 3). Claim 9, reproduced below, is representative of the subject matter on appeal. 9. A tracheostomy tube comprising: a shaft including a patient end and a cuff having an inflatable portion on an outside surface of the shaft towards the patient end that is adapted, during use, to provide a seal with the tracheal wall, the cuff being attached to the shaft by means of a patient end collar and a machine end collar, the shaft being a tubular shaft having a bore extending along its length, the bore adapted to receive a removable inner cannula, wherein at least the patient end collar is inverted within the inflatable portion of the cuff so that it does not extend beyond the inflatable portion of the cuff, and wherein the patient end collar is attached to the outside surface of the shaft immediately adjacent the patient end of the shaft so that substantially no part of the shaft protrudes from the inflatable portion of the cuff and that the cuff has an inflated shape with a tapering substantially frusto-conical profile at a patient end region such that the inflated portion of the cuff only extends substantially right to the patient end of the shaft so as not to extend beyond the patient end of the shaft. THE REJECTIONS The Examiner relies upon the following as evidence in support of the rejections: Name Reference Date Pagan GB 2 344 528 A Nov. 17, 1999 Lieberman US 4,596,248 June 24, 1986 Nelson US 2007/0295337 A1 Dec. 27, 2007 Behlmaier US 2012/0103341 A1 May 3, 2012 Appeal 2021-002757 Application 15/112,785 3 The following rejections are before us for review: 1. Claims 9, 10, and 13–16 are rejected under 35 U.S.C. § 103 as unpatentable over Lieberman, and an alternative embodiment of Lieberman in Figure 2, and Nelson. 2. Claim 17 is rejected under 35 U.S.C. § 103 as unpatentable over Lieberman, an alternative embodiment of Lieberman in Figure 2, Nelson, and Behlmaier. 3. Claims 11 and 12 are rejected under 35 U.S.C. § 103 as unpatentable over Lieberman, an alternative embodiment of Lieberman in Figure 2, Nelson, and Pagan. FINDINGS OF FACT We have determined that the findings of fact in the Analysis section below are supported at least by a preponderance of the evidence2. ANALYSIS The Appellant argues that the rejection of claim 9 is improper because the cited combination of references is improper and would not have been obvious (Appeal Br. 5–15, Reply Br. 1–6). In particular, the Appellant argues that claim 9 requires “a tubular shaft having a bore extending along its length, the bore adapted to receive a removable inner cannula” which is not suggested by the combination (Appeal Br. 9, emphasis omitted). The Appellant also argues that the rejection has improperly combined the 2 See Ethicon, Inc. v. Quigg, 849 F.2d 1422, 1427 (Fed. Cir. 1988) (explaining the general evidentiary standard for proceedings before the Patent Office). Appeal 2021-002757 Application 15/112,785 4 references to meet the claim limitation that the “substantially no part of the shaft protrudes from the inflatable portion of the cuff” (Appeal Br. 10). In contrast, the Examiner has determined that the rejection of record is proper (Final Act. 3–5, 9, 10, Ans. 10–12). We agree with the Appellant. Here, claim 9 in part requires: 1) “a tubular shaft having a bore extending along its length, the bore adapted to receive a removable inner cannula”; 2) that “substantially no part of the shaft protrudes from the inflatable portion of the cuff”; and 3) that the cuff has an inflated shape with a tapering “substantially right to the patient end of the shaft so as not to extend beyond the patient end of the shaft.” The Examiner has determined that claim 9 is obvious under Lieberman’s embodiment of Figures 10 and 12, in view of Lieberman’s embodiment of Figures 1 and 2; and Nelson (Final Act. 3-5, 9, Ans. 10–12). Claim 9 requires “a tubular shaft having a bore extending along its length, the bore adapted to receive a removable inner cannula.” Lieberman in Figure 2 fails to show such a tubular shaft with a bore extending along its length, and in contrast the structure has a perpendicular bend between members 20 and 30 such that the bore in member 30 does not extend along the length of the shaft as claimed. Lieberman in the embodiment of Figure 10 also shows the shaft portion (127) protruding beyond the cuff (135). Lieberman at Figure 1 does show a cuff (35) placed at the end of the device. The rejection further requires a modification to include Nelson’s teaching of a frusto-conical end portion of the cuff for a better seal (Lieberman, Fig. 1, para. 34). The rationale for modification in the Final Office Action states that Lieberman’s location for the end collar in Figure 2 is a “known location” for an inflatable cuff for providing a seal and that Nelson’s frusto-conical shape Appeal 2021-002757 Application 15/112,785 5 ensures a tight seal (Final Act. 4, 5; Ans. 11). The Final Office Action states that Lieberman’s end collar in Figure 2 provides a “known location” for mounting, but the rejection fails to provide articulated reasoning with rational underpinnings for a modification to have “substantially no part of the shaft protrud[ing] from the inflatable portion of the cuff” in the cited combination without impermissible hindsight. In the embodiment of Nelson at Figure 10 the shaft portion (127) protruding beyond the cuff (135) has substantially no effect on the seal as it merely protrudes from the center of the device and has no engagement with the sealing surface. Here, the rejection of record lacks articulated reasoning with rational underpinning to modify the tracheal tube of Lieberman in Figure 10 to have the cuff moved to the location disclosed by Lieberman in Figure 2 with substantially no part of the shaft protruding from the cuff,” and to further include the frusto- conical end cuff disclosed by Nelson without impermissible hindsight and a conclusion of obviousness has not been shown. Accordingly, the rejection of claim 9 and its dependent claims are not sustained. Claim 17 contains similar limitations as claim 9, and the rejection of this claim is not sustained for the same reasons given above. CONCLUSIONS OF LAW We conclude that the Appellant has shown that the Examiner erred in rejecting claims 9, 10, and 13–16 under 35 U.S.C. § 103 as unpatentable over Lieberman, an alternative embodiment of Lieberman in Figure 2, and Nelson. We conclude that the Appellant has shown that the Examiner erred in rejecting claim 17 under 35 U.S.C. § 103 as unpatentable over Lieberman, Appeal 2021-002757 Application 15/112,785 6 an alternative embodiment of Lieberman in Figure 2, Nelson, and Behlmaier. We conclude that the Appellant has shown that the Examiner erred in rejecting claims 11 and 12 under 35 U.S.C. § 103 as unpatentable over Lieberman, an alternative embodiment of Lieberman in Figure 2, Nelson, and Pagan. DECISION SUMMARY Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 9, 10, 13–16 103 Lieberman, an alternative embodiment of Lieberman in Figure 2, Nelson 9, 10, 13–16 17 103 Lieberman, an alternative embodiment of Lieberman in Figure 2, Nelson, Behlmaier 17 11, 12 103 Lieberman, an alternative embodiment of Lieberman in Figure 2, Nelson, Pagan 11, 12 Overall Outcome 9–17 REVERSED