Fresenius Medical Care Holdings, Inc. et al.

Patent Trials and Appeals Board

Mar 4, 2022

2021001914 (P.T.A.B. Mar. 4, 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. 15/669,287 08/04/2017 Martin Joseph Crnkovich 18196-0291001 2626 26216 7590 03/04/2022 FISH & RICHARDSON P.C. (FRESENIUS) P.O. BOX 1022 MINNEAPOLIS, MN 55440-1022 EXAMINER PEO, JONATHAN M ART UNIT PAPER NUMBER 1779 NOTIFICATION DATE DELIVERY MODE 03/04/2022 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): PATDOCTC@fr.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte MARTIN JOSEPH CRNKOVICH, DAVID YUDS, and CHRISTIAN SCHLAEPER Appeal 2021-001914 Application 15/669,287 Technology Center 1700 Before ADRIENE LEPIANE HANLON, JEFFREY T. SMITH, and LINDA M. GAUDETTE, Administrative Patent Judges. SMITH, 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 1-25. 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. Appellant identifies the real parties in interest as Fresenius Medical Care Holdings, Inc. and Fresenius Medical Care Deutschland GmbH. (Appeal Br. 3.) Appeal 2021-001914 Application 15/669,287 2 CLAIMED SUBJECT MATTER The claims are directed to an extracorporeal blood treatment system and a method of operating such systems to infuse blood into a patient. (Spec. 1.) Claim 1, reproduced below, is illustrative of the claimed subject matter: 1. A method comprising: clamping an access line of an arterial line set, the arterial line set comprising an arterial line connected to the access line, and the access line being connectable to an arterial access of a patient such that the access line is between a fluid pump and the arterial access; after clamping the access line, initiating an operation to generate negative pressure, using the fluid pump, in a portion of the arterial line set between the fluid pump and the access line; after generating the negative pressure in the portion of the arterial line set, unclamping the access line such that the negative pressure generated in the portion of the arterial line set before unclamping the access line draws fluid in the access line further into the arterial line set in a direction away from an end of the access line that is connectable to the arterial access of the patient; and initiating an operation of the fluid pump engaged with the arterial line set such that the fluid in the arterial line set is infused into the patient through a venous line set. (Appeal Br. (Claims App.) 20.) REJECTIONS The Examiner maintains the following rejections: I. Claims 1, 3, 4, 9-18, and 22-252 are rejected under 35 U.S.C. § 103 as obvious over Kelly ’657 (US 2016/0030657 A1; pub. Feb. 4, 2016), in view of Kopperschmidt (US 2016/0074571 A1; pub. Mar. 17, 2016). 2 Claim 25 was omitted from the statement of the rejection but was included in the discussion of the rejection. (Final Act. 5.) We determine this is harmless error. Appeal 2021-001914 Application 15/669,287 3 II. Claims 2 and 21 are rejected under 35 U.S.C. § 103 as obvious over Kelly ’657 and Kopperschmidt in further view of Miller (US 2013/0310726 A1; pub. Nov. 21, 2013). III. Claims 5-8 and 20 are rejected under 35 U.S.C. § 103 as obvious over Kelly ’657 and Kopperschmidt in further view of Kelly ’331 (US 2005/0131331 A1; pub. June 16, 2005). IV. Claim 19 is rejected under 35 U.S.C. § 103 as obvious over Kelly ’657 and Kopperschmidt in further view of Kenley (US 5,690,831; iss. Nov. 25, 1997). OPINION The dispositive issue on appeal is: Did the Examiner reversibly err in determining the combination of Kelly ’657 and Kopperschmidt suggests an extracorporeal blood treatment system and a method of operating an extracorporeal blood treatment system including generating a negative pressure in an arterial access line using a fluid pump, in a portion of the arterial line set between the fluid pump and the access line while the access line is clamped so that the negative pressure can draw fluid in the access line further into the access line when the access line is unclamped as required by independent claims 1 and 17? We answer the above question in the affirmative.3 Appellant argues the combination of Kelly ’657 and Kopperschmidt fails to disclose or suggest clamping an access line of an arterial line set, initiating an operation to generate negative pressure, and unclamping the access line such that the negative pressure generated in the portion of the 3 Our analysis applies to both independent claims 1 and 17. However, we limit our discussion to independent claim 1. Appeal 2021-001914 Application 15/669,287 4 arterial line set before unclamping the access line draws fluid in the access line further into the arterial line set. (Appeal Br. 20.) Appellant argues the saline line 372 of Kelly ’657 cannot correspond to the claimed access line because line 372 is not positioned between a fluid pump and an arterial access and therefore not connectable to a patient’s access line. (Appeal Br. 12.) The Examiner finds4 Kelly discloses a method of operating an extracorporeal blood treatment system to infuse blood into a patient after an extracorporeal blood treatment wherein the method comprises: clamping an access line of an arterial line set, (Valve V12 on Line 372, Figure 26, and See paragraphs [00247], [0248] & [0250]; paragraph [0248] states that V12 is opened, indicating that it was clamped initially), the arterial line set comprising an arterial line connected to the access line, (Portion of Arterial Line 44a between Pump 48 and junction with Line 372, See Figure 26, and See paragraph [0250]), and the access line being connectable to an arterial access of the patient, (Line 372 connected to Arterial Line 44a, See Figure 26, See paragraph [0243]; the end of Arterial Line 44a is capable of connection to patient), such that the access line is between a fluid pump and the arterial access, (Branch of Line 372 joins between Pump 48 and Arterial Line 44a as well as end of Line 44a . . .). (Final Act. 6; Kelly ’657 ¶¶ 243-250, Fig. 26.) The Examiner finds Kelly ’657 does not disclose the operation to drive fluid in the arterial line set is an operation to generate negative pressure in a portion of the arterial line set. (Final Act. 7.) Addressing this difference, the Examiner cites Kopperschmidt. The Examiner concludes it would have been obvious 4 The complete statement of the rejections on appeal appear in the Final Action. (Final Act. 5-22.) Appeal 2021-001914 Application 15/669,287 5 to have modified the method of operating an extracorporeal blood treatment system to infuse blood into a patient after an extracorporeal blood treatment of Kelly [’657] by incorporating that the operation to drive fluid in a portion of the arterial line set is an operation to generate negative pressure in the arterial line set as in Kopperschmidt. (Final Act. 7.) The relevant portion of Kelly ’657 figure 26 is reproduced below: The excerpt of Figure 26 reproduced above depicts the arterial (patient access) line 44a that travels around the circulation pump 48, a separate saline fluid bag 368 connected to the extracorporeal circuit via saline line 372. The valves V11 and V12 are positioned in saline line 372 so as to allow saline to flow selectively to one of or both of the connections upstream and downstream of blood pump 48. (Kelly ’657 ¶¶ 243-245; Figure 26.) The Examiner asserts “that line 372 in Figure 26 of Kelly [’657] is directly connected to the set of lines on the arterial side of the patient including line 44a, making it part of the ‘arterial line set’ as claimed.” (Ans. 22.) Appeal 2021-001914 Application 15/669,287 6 Contrary to the Examiner’s position, Kelly ’657 does not disclose that the saline line 372 is positioned between a fluid pump and an arterial access but, rather, only shows that the saline line 372 is between the saline fluid bag 368 and the arterial line or arterial access line 44a. Furthermore, while the arterial access line 44a is connectable to an arterial access, the saline line 372 is not connectable to an arterial access of a patient such that the access line is between a fluid pump and the arterial access as required by the independent claims. The Examiner has failed to identify where Kelly ’657 describes clamping the arterial line set 44a in a manner that would render the claimed invention obvious. For the foregoing reasons the Examiner has failed to establish the combination of Kelly ’657 and Kopperschmidt discloses or renders obvious clamping an access line of an arterial line set, the arterial line set comprising an arterial line connected to the access line, and the access line being connectable to an arterial access of a patient such that the access line is between a fluid pump and the arterial access, as required by independent claim 1. Thus, we do not sustain the Examiner’s obviousness rejections of claims 1, 3, 4, 9-18, and 22-25. The additional references cited in Rejections II-IV, in addition to Kelly ’657, and Kopperschmidt, do not address the deficiency in the rejection of the independent claims discussed above. CONCLUSION The Examiner’s prior art rejections are reversed. Appeal 2021-001914 Application 15/669,287 7 DECISION SUMMARY In summary: Claim(s) Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1, 3, 4, 9- 18, 22-25 103 Kelly ’657, Kopperschmidt 1, 3, 4, 9- 18, 22-25 2, 21 103 Kelly ’657, Kopperschmidt, Miller 2, 21 5-8, 20 103 Kelly ’657, Kopperschmidt, Kelly ’331 5-8, 20 19 103 Kelly ’657, Kopperschmidt, Kenley 19 Overall Outcome 1-25 REVERSED