Ex Parte Rohde et al

Patent Trial and Appeal BoardSep 20, 2018

12180324 (P.T.A.B. Sep. 20, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 12/180,324 07/25/2008 29200 7590 K&L Gates LLP-Chicago Baxter P.O. Box 1135 Chicago, IL 60690-1135 09/24/2018 FIRST NAMED INVENTOR Justin B. Rohde 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 ATTORNEY DOCKET NO. CONFIRMATION NO. P5404USOO BX2009TO 1854 9802 EXAMINER BASS,DIRKR ART UNIT PAPER NUMBER 1779 NOTIFICATION DATE DELIVERY MODE 09/24/2018 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 JUSTIN B. ROHDE and SHINCY J. MALIEKKAL Appeal 2017-011556 Application 12/180,324 Technology Center 1700 Before CATHERINE Q. TIMM, BEYERL YA. FRANKLIN, and MICHAEL G. McMANUS, Administrative Patent Judges. TIMM, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Pursuant to 35 U.S.C. Â§ 134(a), Appellants 1 appeal from the Examiner's decision to reject claims 1, 2, 4--12, and 29--35 under 35 U.S.C. Â§ 103(a) as obvious over Lindsay2 in view of Smith3 and claims 17- 1 Appellants identify the real parties in interest as Baxter International, Inc. and Baxter Healthcare S.A. Appeal Br. 2. 2 US 4,107,039, issued Aug. 15, 1978 3 US 3,805,817, issued Apr. 23, 1974. Appeal 2017-011556 Application 12/180,324 19 and 26-28 under 35 U.S.C. Â§ 103(a) as obvious over Kenley4 in view of Smith. We have jurisdiction under 35 U.S.C. Â§ 6(b). We REVERSE. The claims are directed to a dialysis system with a flow regulation device located between a purified water source and a dialysis machine. See, e.g., claims 1, 17 (flow control mechanism), 29. The flow regulation device includes a compliant material. See, e.g., claims 1, 17, 29. The compliant material may form the walls of the flow regulation device. Spec. ,r 35, see Figs. 3, 4. Use of compliant material in the walls allows the walls to expand and contract depending on the flow requirements of the dialysis device. Id. Suitable compliant materials are said to include elastomers and plastics, such as natural rubber latex, PVC, polyurethane, or silicone. Id. Figures 3 and 4, which depict a flow regulation device with expandable walls 46, 48 of compliant material, show a device encompassed by claims 1 and 29. Only those embodiments of the pleated wall of Figure 5 containing a material that is compliant, such as an elastomer, are encompassed by the claims. Spec. ,r 3 7. Appellants' Figure 6 embodiment uses a rigid container not made of a compliant material (Spec. ,r 39), and, thus, the claims on appeal do not encompass the Figure 6 embodiment. 4 US 5,591,344, issued Jan. 7, 1997. 2 Appeal 2017-011556 Application 12/180,324 Claim 1, with portions of the claim most at issue highlighted, is illustrative: Claim 1: A dialysis system comprising: a dialysis machine with a variable fluid demand including at least a lower demand and a higher demand; a purified water source in fluid communication with the dialysis machine and providing purified water to the dialysis machine at a fluid flow rate; and a flow regulation device comprising a closed volume having a cross-sectional area larger than that of its purified water inlet and purified water outlet, the inlet in fluid communication with the purified water source, the outlet in fluid communication with the dialysis machine, the flow regulation device including a compliant material in sealed communication with the purified water inlet and the purified water outlet such that the purified water contacts the compliant material without passing through the compliant material, the compliant material operable to expand and contract to provide a variable internal volume, and wherein the compliant material of the flow regulation device expands when the dialysis machine has the lower demand and contracts when the dialysis machine has the higher demand. Appeal Br. 24 (claims appendix)(emphasis added). OPINION Turning first to the Examiner's rejection of claims 1, 2, 4--12, and 29-- 35 under 35 U.S.C. Â§ 103(a) as obvious over Lindsay in view of Smith, we determine that Appellants have identified a reversible error in the Examiner's finding of a reason to modify Lindsay's device with Smith's diaphragm. 3 Appeal 2017-011556 Application 12/180,324 The Examiner finds Lindsay discloses a flow regulation device (12/31) with a compliant material (constant force spring). Final 3. Lindsay, in fact, teaches a regulator valve 12 that receives purified water from source 11. Lindsay col. 2, 11. 52-59, Fig. 1. The purified water passes through valve 12 to valves 13 and 14 and is mixed with concentrate from tank 15 to form a dialysate solution and, while still under pressure from the valve 12, is supplied to closed mixing vessel 16. Id. The dialysate is then supplied to a constant pressure volume sensing chamber 29 and it is this chamber 29 that contains the component ( constant force spring assembly 31) that the Examiner relies on, in combination with valve 12, as part of a flow regulation device. Lindsay col. 3, 11. 37-55, Fig. 1; Final 3. The valve 12 and chamber 29 containing constant force spring 31 are different devices within the apparatus. Lindsay Fig. 1. It is not entirely clear from the rejection how the Examiner is relying on valve 12 in combination with constant force spring 31 to meet the requirements of the flow regulation device of the claims. In any case, the Examiner further finds that "Lindsay does not explicitly disclose a flow regulation device having a compliant material which contacts fluid during use." Final 3. The Examiner turns to Smith as evidence that "direct control flow regulation systems comprising compliant materials is [ sic, are] very well known in the art." Final 3. The Examiner concludes that "it would have been obvious to one having ordinary skill in the art to modify the system of Lindsay to utilize the flow control system as described in Smith for providing direct control of fluid flow rates through the system and 4 Appeal 2017-011556 Application 12/180,324 maintaining a constant pressure of fluid within said system." Final 3--4, citing Smith col. 1, 11. 1-14. First, we determine that the Examiner has inadequately explained which portions of Lindsay's system the ordinary artisan would modify. Smith discloses a constricting means 22 with cylindrical diaphragm 3 8 that is used to control the pressure and flow rate of sewage passing through a sewer pipe. Smith col. 4, 1. 63 to col. 5, 1. 28. Lindsay's constant pressure volume sensing chamber 29, which includes constant force spring assembly 31, is for a different purpose; the purpose of sensing pressure. Lindsay col. 3, 11. 37-55. The constant force spring assembly merely maintains a constant bias against the pressure in the sensing chamber. Id. Thus, the ordinary artisan would not merely replace the constant force spring assembly 31 or the combination of the valve 12 and constant force spring assembly 31 with Smith's diaphragm. The Examiner did not identify which of Lindsay's structures the ordinary artisan would modify. Perhaps the Examiner is suggesting that one would replace both Lindsay's sensing chamber 29 and linkage to valve 12 that moves the valve 12 in response to the movement of piston 30 within chamber 29, but the reasoning is not sufficiently developed by the Examiner to support such a modification with Smith's diaphragm 38. The modification in this instance would involve multiple changes to Lindsay's dialysate preparation system that are not straightforward and not explained by the Examiner. Thus, we determine that the Examiner has failed to adequately support the finding of a suggestion to make the modification. 5 Appeal 2017-011556 Application 12/180,324 Turning to the rejection of claims 17-19 and 26-28 under 35 U.S.C. Â§ 103 (a) as obvious over Kenley in view of Smith, we determine the Examiner's reason for modifying Kenley's three-way valve 108 with Smith's diaphragm 38 lacks sufficient evidentiary support. The Examiner finds Kenley's three-way valve 108 is a flow control mechanism. Final 6. Kenley does not disclose valve 108 as "including a closed volume having a cross-sectional diameter larger than its inlet and outlet diameters and including a compliant material" as required by claim 17. Thus, the Examiner turns to Smith for its teaching of diaphragm 38. Id. The Examiner concludes "it would have been obvious to one having ordinary skill in the art to modify the system of Kenley to utilize the flow control system as described in Smith for providing direct control of fluid flow rates through the system and maintaining a constant pressure of fluid within said system." Id., citing Smith, col. 1, 11. 1-14. Kenley's valve 108 is a three-way valve. Kenley col. 12, 11. 32--44. Three-way valve 108 is connected to drain lines 109 and 116 as well as to line 111 that leads to dialysate preparation module 26. Id. Kenley does not disclose restricting the flow in either the drain lines 109/116 or line 111. Moreover, the Examiner offers no reasonable explanation of why one would have replaced a valve that diverts the fluid to different lines with a flow restricting diaphragm that does not divert fluid in the manner required by the valve. 6 Appeal 2017-011556 Application 12/180,324 In summary: CONCLUSION 1, 2, 4--12, Â§ 103(a) Lindsay, Smith 29--35 17-19, 26- Â§ 103(a) Kenley, Smith 28 Summary DECISION The Examiner's decision is reversed. REVERSED 7 1, 2, 4--12, 29--35 17-19, 26- 28 1, 2, 4--12, 17-19, 26- 35