2020005927 (P.T.A.B. Oct. 12, 2021)

GAMBRO LUNDIA AB

Patent Trials and Appeals BoardOct 12, 2021

2020005927 (P.T.A.B. Oct. 12, 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. 15/240,421 08/18/2016 Martin Furmanski 3724361.00216 2114 29178 7590 10/12/2021 K&L Gates LLP - Gambro P. O. BOX 1135 CHICAGO, IL 60690-1135 EXAMINER KUAN, JOHN CHUNYANG ART UNIT PAPER NUMBER 2857 NOTIFICATION DATE DELIVERY MODE 10/12/2021 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): uspatentmail@klgates.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte MARTIN FURMANSKI, ANDERS ROSLUND, BO OLDE, KRISTIAN SOLEM, THOMAS HERTZ, and JAN STERNBY Appeal 2020-005927 Application 15/240,421 Technology Center 2800 Before TERRY J. OWENS, JEFFREY B. ROBERTSON, and JENNIFER R. GUPTA, Administrative Patent Judges. OWENS, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Pursuant to 35 U.S.C. § 134(a), the Appellant1 appeals from the Examiner’s decision to reject claims 1–23. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. 1“Appellant” refers to “applicant” as defined in 37 C.F.R. § 1.42. The Appellant identifies the real party in interest as Gambro Lundia AB (Appeal Br. 2). Appeal 2020-005927 Application 15/240,421 2 CLAIMED SUBJECT MATTER The claims are directed to methods and devices for monitoring the integrity of a fluid connection. Claim 1, reproduced below, is illustrative of the claimed subject matter: 1. A method for monitoring the integrity of a fluid connection between first and second fluid containing systems based on at least one time-dependent measurement signal from at least one pressure sensor in the first fluid containing system, wherein the first fluid containing system includes an extracorporeal blood flow circuit comprising an arterial access device, a blood processing device, a venous access device and a first pulse generator, and the second fluid containing system includes a human blood system comprising a blood vessel access and a second pulse generator, wherein: the arterial access device is for connecting to the human blood system, the venous access device is connected to the blood vessel access to form the fluid connection, the first pulse generator includes a pumping device arranged in the extracorporeal blood flow circuit to pump blood from the arterial access device through the blood processing device to the venous access device, and the at least one pressure sensor is arranged to detect first pulses originating from the first pulse generator and second pulses originating from the second pulse generator, said method comprising: receiving, at a processor, said at least one time-dependent measurement signal from the at least one pressure sensor; generating, by the processor, a time-dependent monitoring signal based on said at least one-time dependent measurement signal in which the first pulses are eliminated; calculating, by the processor, a parameter value based on signal segment profile values within a time window in the time- dependent monitoring signal, the parameter value representing a distribution of the signal segment profile values, wherein said calculating includes matching the signal segment profile values within the time window to a predicted temporal signal profile of the second pulses; Appeal 2020-005927 Application 15/240,421 3 determining, by the processor, the integrity of the fluid connection based at least partly on the parameter value; and controlling blood flow through the extracorporeal blood flow circuit based at least in part on the parameter value. REFERENCES The references relied upon by the Examiner are: Name Reference Date Hertz US 6,090,048 July 18, 2000 Georgopoulos US 2008/0091118 A1 Apr. 17, 2008 Weitzel US 2008/0108930 A1 May 8, 2008 Bennison US 2009/0082676 A1 Mar. 26, 2009 Furmanski US 9,442,036 B2 Sept. 13, 2016 REJECTIONS The claims stand rejected as follows: 1) claims 1, 4, 7–17, and 21–23 on the ground of nonstatutory obviousness-type double patenting over claims 1–23 of Furmanski in view of Hertz; 2) claims 2, 3, 5, and 6 on the ground of nonstatutory obviousness-type double patenting over claims 1–23 of Furmanski in view of Hertz, Bennison, and Georgopoulos; 3) claim 18 on the ground of nonstatutory obviousness-type double patenting over claims 1–23 of Furmanski in view of Hertz and Weitzel; 4) claims 19 and 20 on the ground of nonstatutory obviousness-type double patenting over claims 1–23 of Furmanski in view of Hertz and Georgopoulos; 5) claims 1, 4, 7, and 22 under 35 U.S.C. § 102(b) over Hertz; 6) claims 8–17, 21, and 23 under 35 U.S.C. § 103(a) over Hertz; 7) claims 2, 3, 5, and 6 under 35 U.S.C. § 103(a) over Hertz in view of Bennison and Georgopoulous; 8) claim 18 under 35 U.S.C. § 103(a) over Hertz in view of Weitzel; and 9) claims 19 and 20 under 35 U.S.C. § 103(a) over Hertz in view of Georgopoulos. Appeal 2020-005927 Application 15/240,421 4 OPINION Obviousness-type double patenting rejections The Appellant does not challenge the obviousness-type double patenting rejections (Appeal Br. 11–19). We therefore summarily affirm those rejections. Rejection under 35 U.S.C. § 102(b) We need address only the independent claims (1 and 22). Those claims require a method or device for obtaining at least one time-dependent measurement signal from at least one pressure sensor arranged to detect first pulses originating from a first pulse generator (such as a blood pump) and second pulses originating from a second pulse generator (such as a human heart), eliminating the first pulses from the at least one time-dependent measurement signal, generating, by a processor, a time-dependent monitoring signal based on the at least one time-dependent measurement signal in which the first pulses are eliminated (thereby obtaining signal segment profile values), and matching signal segment profile values within a time window in the time-dependent monitoring signal to a predicted temporal signal profile of the second pulses (such as a normal heartbeat). “Anticipation requires that every limitation of the claim in issue be disclosed, either expressly or under principles of inherency, in a single prior art reference.” Corning Glass Works v. Sumitomo Elec. U.S.A., Inc., 868 F.2d 1251, 1255–56 (Fed. Cir. 1989). Hertz subtracts from a pressure wave sensed by an extracorporeal blood flow circuit’s pressure sensor, a signal corresponding to a pressure wave obtained from a blood pump, thereby obtaining a pressure signal corresponding to a patient’s heartbeat, and triggers an alarm signal when that Appeal 2020-005927 Application 15/240,421 5 pressure signal’s amplitude is below 20% of the amplitude of the pressure signal for a normal heartbeat (col. 3, ll. 16–21; col. 7, ll. 4–10). The Examiner finds: [Hertz’s] “calculating includes matching (i.e., comparing the amplitudes) the signal segment profile values within the time window to a predicted temporal signal profile of the second pulses (i.e., comparing pulse signals from venous 15 and arterial sensor 4, or comparing to a normal amplitude; see col. 7, lines 4-49 and FIG. 6) within a time window (i.e., the time spanning of the pulse; note that amplitude of a periodic variable is a measure of its change over a single period) in the time-dependent monitoring signal (see FIG. 6).” [(Final 8)] . . . . “Since a pulse is represented by a time series of signal values, the calculating of the amplitude percentage between the two signals would be a matching of the signal segment profile values within the time window to a predicted temporal signal profile of the second pulses” [(Ans. 6)]. “[D]uring examination proceedings, claims are given their broadest reasonable interpretation consistent with the specification.” In re Translogic Tech. Inc., 504 F.3d 1249, 1256 (Fed. Cir. 2007) (quoting In re Hyatt, 211 F.3d 1367, 1372 (Fed. Cir. 2000)). The Examiner does not establish that Hertz’s comparing sensed pulse amplitudes to normal amplitudes is matching signal segment profile values to a predicted temporal signal profile as the term “matching” is most broadly interpreted consistently with the Appellant’s Specification. The Appellant’s matching requires not only comparing segment profile values within a time window to a predicted temporal signal profile of second pulses, but also requires selecting the comparison at which the segment profile values match the predicted temporal signal profile. The Examiner does not establish that Appeal 2020-005927 Application 15/240,421 6 Hertz’s comparing of sensed pulse amplitudes to normal heartbeat amplitudes (col. 7, ll. 4–10) meets that requirement. Thus, the Examiner has not shown that every limitation of the claims in issue is disclosed, either expressly or under principles of inherency, in a single prior art reference. Accordingly, we reverse the rejection under 35 U.S.C. § 102(b). Rejections under 35 U.S.C. § 103 The Examiner does not establish that Hertz, alone or in combination with the other applied references, would have rendered prima facie obvious, to one of ordinary skill in the art, the claim requirement discussed above with respect to the rejection under 35 U.S.C. § 102(b) that is in all independent claims (1, 22, and 23) (Final 10–27). Hence, we reverse the rejections under 35 U.S.C. § 103. CONCLUSION The obviousness-type double patenting rejections are affirmed, and the rejections under 35 U.S.C. §§ 102(b) and 103 are reversed. DECISION SUMMARY In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1, 4, 7–17, 21–23 Nonstatutory double patenting Furmanski, Hertz 1, 4, 7–17, 21–23 2, 3, 5, 6 Nonstatutory double patenting Furmanski, Hertz, Bennison, Georgopoulos 2, 3, 5, 6 Appeal 2020-005927 Application 15/240,421 7 18 Nonstatutory double patenting Furmanski, Hertz, Weitzel 18 19, 20 Nonstatutory double patenting Furmanski, Hertz, Georgopoulous 19, 20 1, 4, 7, 22 102(b) Hertz 1, 4, 7, 22 8–17, 21, 23 103(a) Hertz 8–17, 21, 23 2, 3, 5, 6 103(a) Hertz, Bennison, Georgopoulous 2, 3, 5, 6 18 103(a) Hertz, Weitzel 18 19, 20 103(a) Hertz, Georgopoulous 19, 20 Overall Outcome 1–23 TIME PERIOD FOR RESPONSE 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