Pascal Kopperschmidt et al.

Patent Trials and Appeals Board

Jan 28, 2022

2021005458 (P.T.A.B. Jan. 28, 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. 13/512,133 08/09/2012 Pascal Kopperschmidt 3063-015 5813 33432 7590 01/28/2022 KILYK & BOWERSOX, P.L.L.C. 400 HOLIDAY COURT SUITE 102 WARRENTON, VA 20186 EXAMINER OLIVERA, ANGEL J ART UNIT PAPER NUMBER 1773 NOTIFICATION DATE DELIVERY MODE 01/28/2022 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): LKILYK@KBPATENTLAW.COM docketing@kbpatentlaw.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte PASCAL KOPPERSCHMIDT and ALFRED GAGEL Appeal 2021-005458 Application 13/512,133 Technology Center 1700 Before TERRY J. OWENS, BEVERLY A. FRANKLIN, and DONNA M. PRAISS, 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 31, 35, 40, 57, 58, and 60-63. We have jurisdiction under 35 U.S.C. § 6(b). We REVERSE. 1 “Appellant” refers to “applicant” as defined in 37 C.F.R. § 1.42. The Appellant identifies the real party in interest as Fresenius Medical Care Deutschland GmbH (Appeal Br. 3). Appeal 2021-005458 Application 13/512,133 2 CLAIMED SUBJECT MATTER The claims are directed to a hemodiafiltration apparatus. Claim 31, reproduced below, is illustrative of the claimed subject matter: 31. An apparatus for hemodiafiltration treatment, comprising: an extracorporeal blood circuit comprising a blood pump; a dialyzing fluid system; a dialyzer divided by a semipermeable membrane into a blood chamber and a dialyzing fluid chamber, the blood chamber being part of the extracorporeal blood circuit, the dialyzing fluid chamber being part of the dialyzing fluid system, and the blood pump being arranged along the extracorporeal blood circuit upstream of the blood chamber; a substituate dose rate controller configured to increase or decrease a rate of dosing substituate to the extracorporeal blood circuit; a sensor system for ascertaining a rheological loading of the dialyzer, the sensor system comprising a three-point measuring system for measuring transmembrane pressure, and a pressure pulse measuring sensor for measuring longitudinal flow resistance along the dialyzer fibers; and a control unit in communication with the sensor system and the substituate dose rate controller, wherein the sensor system, together with the control unit, is configured to ascertain a transmembrane pressure and a longitudinal flow resistance along the dialyzer fibers, and the control unit is configured to (1) plot a first evaluation quantity (HEMO_Priority) based on a measured transmembrane pressure, (2) plot a second evaluation quantity (BLKD_Priority) based on a measured longitudinal flow resistance along the dialyzer fibers, (3) form a priority pair (HEMO_Priority/BLKD_Priority) from the first evaluation quantity and the second evaluation quantity, (4) compare the priority pair to priority pairs in a two dimensional matrix that assigns to each priority pair a substituate dose rate increase or decrease value, (5) based on the comparison, assign a Appeal 2021-005458 Application 13/512,133 3 corresponding substituate dose rate increase or decrease value, and (6) control a rate of dosing substituate based on the priority pair and the corresponding assigned substituate dose rate increase or decrease value. REFERENCES The prior art relied upon by the Examiner is: Name Reference Date Polaschegg US 5,092,836 Mar. 3, 1992 Kopperschmidt US 2010/0137777 A1 June 3, 2010 Spickermann2 WO 2009/080258 A1 July 2, 2009 REJECTIONS The claims stand rejected under 35 U.S.C. § 103(a) as follows: claims 31, 58, and 60-63 over Spickermann in view of Polaschegg, and claims 35, 40, and 57 over Spickermann in view of Polaschegg and Kopperschmidt. OPINION We need address only the independent claims (31 and 57). Claim 31 Claim 31 requires a control unit configured to: (1) plot a first evaluation quantity (HEMO_Priority) based on a measured transmembrane pressure, (2) plot a second evaluation quantity (BLKD_Priority) based on a measured longitudinal flow resistance along the dialyzer fibers, (3) form a priority pair (HEMO_Priority/BLKD_Priority) from the first evaluation quantity and the second evaluation quantity, (4) compare the priority pair to priority pairs in a two dimensional matrix that 2 The Examiner refers to this reference and its relied-upon English language equivalent (US 2010/0280761 A1 (Nov. 4, 2010)) as Spickermann, the last named inventor, rather than Balschat, the first-named inventor (Non-final 7). For consistency, we likewise do so. The Spickermann citations herein are to US 2010/0280761 A1. Appeal 2021-005458 Application 13/512,133 4 assigns to each priority pair a substituate dose rate increase or decrease value, (5) based on the comparison, assign a corresponding substituate dose rate increase or decrease value, and (6) control a rate of dosing substituate based on the priority pair and the corresponding assigned substituate dose rate increase or decrease value. The Examiner cites portions of that control unit requirement, one at a time, and then after each citation, cites a portion of Spickermann (Non- final 7-19). The Examiner, however, does not establish that the cited portion of Spickermann discloses, or would have suggested to one of ordinary skill in the art, the corresponding cited portion of the claim requirement. For example, the Examiner cites the control unit requirement, “control a rate of dosing substituate based on the priority pair and the corresponding assigned substituate dose rate increase or decrease value,” and then cites to Spickermann: (see, ¶ [0040] “Blood pump 8, first and second dialyzing fluid pump 13 and 14 and substituate pump 16 are connected via control lines 8', 13', 14', 16' to a central control and computing unit 18, from which the pumps are controlled taking account of the preselected treatment parameters.”; and, ¶ [0089] “Corrected transmembrane pressure TMP may be displayed on a display unit (not shown) and/or be used for controlling or regulating the blood treatment apparatus”; see also ¶ [0021] “It has been shown that the deviations between the transmembrane pressure that is calculated on the basis of a measurement with less than four pressure sensors and the actual transmembrane pressure increases with increasing flow resistance of the dialyzer in the longitudinal direction.”; the substituate rate is controlled by the corrected transmembrane pressure. The corrected transmembrane pressure is calculated from the evaluation pair of the calculated transmembrane pressure and the calculated longitudinal flow resistance; see SPICKERMANN Formula 6, showing that the evaluation pair Appeal 2021-005458 Application 13/512,133 5 is used to calculate the actual transmembrane pressure (PTM) of the apparatus from the calculated transmembrane pressure (PTM3), which reads on the first evaluation property HEMO Priority, and the calculated longitudinal flow resistance (Rb), which reads on the second evaluation property BLKD_Priority). [(Non-final 10-11)] The Examiner does not explain how the cited portion of Spickermann discloses, or would have suggested, to one of ordinary skill in the art, “control a rate of dosing substituate based on the priority pair and the corresponding assigned substituate dose rate increase or decrease value.” The Examiner then finds that Spickermann is silent as to that control unit requirement, but finds (Non-final 11-12): POLASCHEGG further teaches that the use of a control plot, as claimed, or a polynomial calculation, as taught by SPICKERMANN, are known equivalents in the art of controlling a hemodialysis apparatus (see column 3, line(s) 17- 32 “The control device (100) is so constructed and regulated that the output signal of the automatic control which regulates the dialysis solution flow is a predetermined function of the input signal derived from the blood flow. This function is derived according to predetermined criteria from the area of clearance performance (clearance as a function of dialysis solution flow and blood flow). In the simplest case this predetermined function is a linear one. It can also be given in the form of a polynomial or by numerical data fed into in a matrix in the control circuit which, for every blood flow of one dialyser, gives the dialysis solution flow at which a certain percentage of the clearance (e.g. 95%) is reached, when the dialysis solution flow is infinite. In this case the control function is stored in a so called table.”) comparing evaluation quantities to control a rate of dosing substituate (see column 3, line(s) 30-32 “In this case the control function is stored in a so- called table”) in order to determine the substituate rate (see column 3, line(s) 25-30 “It can also be given in the form of a polynomial or by numerical data fed into in a matrix in the Appeal 2021-005458 Application 13/512,133 6 control circuit which, for every blood flow of one dialyser, gives the dialysis solution flow at which a certain percentage of the clearance (e.g. 95%) is reached”). The Examiner does not establish that Spickermann discloses, or would have suggested to one of ordinary skill in the art, a priority pair corresponding to the Appellant’s HEMO_Priority/BLKD_Priority and comparing the priority pair to priority pairs using a polynomial calculation that assigns to each priority pair a substituate dose rate increase or decrease value. Thus, the Examiner does not establish that one of ordinary skill in the art could arrive at the Appellant’s control unit requirement by substituting a matrix for a polynomial calculation. Moreover, the Examiner does not establish that Polaschegg’s disclosure of feeding a polynomial or numerical data into a control circuit matrix “which, for every blood flow of one dialyser, gives the dialysis solution flow at which a certain percentage of the clearance (e.g. 95%) is reached, when the dialysis solution flow is infinite” (col. 3, ll. 26-30) would have suggested, to one of ordinary skill in the art, comparing the Appellant’s priority pair to priority pairs in a two dimensional matrix that assigns to each priority pair a substituate dose rate increase or decrease value. The Examiner concludes (Non-final 12): [I]t would have been obvious to a person having ordinary skill in the art at the time of invention to combine a control matrix stored in the memory of the controller to determine the substituate rate as taught by POLASCHEGG in the controller of the dialysis apparatus of SPICKERMANN in order to yield the predictable result of determining the substituate rate base[d] on the process conditions. Further, it would have been obvious to one having ordinary skill in the art at the time the invention was made to Appeal 2021-005458 Application 13/512,133 7 substitute the polynomial controls scheme of SPICKERMANN with the matrix control scheme taught by POLASCHEGG, since the equivalence of a polynomial control scheme and the matrix control scheme claimed for their use in the dialysis control art is taught by POLASCHEGG, and the selection of any known equivalents to control the substituate rate dialysis apparatus would be within the level of ordinary skill in the art. MPEP 2144.06. Setting forth a prima facie case of obviousness requires establishing that the applied prior art would have provided one of ordinary skill in the art with an apparent reason to modify the prior art to arrive at the claimed invention. See KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007). The Examiner does not establish that the applied prior art would have provided one of ordinary skill in the art with an apparent reason to use Polaschegg’s control matrix to determine a substituate rate or would have indicated to one of ordinary skill in the art that a polynomial control scheme and a matrix control scheme are equivalents for use in controlling a dialysis apparatus substituate rate. Claim 57 Claim 57 requires a control and computing unit configured to: (1) calculate a first evaluation quantity (HEMO_Priority) based on a sensed transmembrane pressure or variable correlating with the transmembrane pressure, (2) calculate a second evaluation quantity (BLKD Priority) based on a sensed longitudinal flow resistance or variable correlating with the longitudinal flow resistance, (3) form an evaluation pair (HEMO_Priority/BLKD_Priority) from the first evaluation quantity and the second evaluation quantity, and (4) regulate the supply of substituate based on the evaluation pair, Appeal 2021-005458 Application 13/512,133 8 As with claim 31, the Examiner cites portions of that control unit requirement, one at a time, and then after each citation, cites a portion of Spickermann, but does not establish that the cited portion of Spickermann discloses, or would have suggested to one of ordinary skill in the art, the corresponding cited portion of the claim requirement (Non-final 21-23). The Examiner combines Spickermann and Polaschegg as with claim 31, (Non- final 32-35), but the Examiner’s reason for combining the references is deficient as set forth above regarding that claim. The Appellant’s claim 57 also requires: wherein the apparatus comprises a memory having stored therein a two dimensional matrix of evaluation pairs and that assigns to each evaluation pair a value corresponding to a required change in substituate rate, wherein the apparatus is configured to compare the evaluation pair formed by the control and computing unit to the evaluation pairs of the two-dimensional matrix, and regulate the substituate rate by changing the substituate rate by a value corresponding to a required change and assigned to the evaluation pair by the two-dimensional matrix, . . . wherein the first evaluation quantity is scaled to be within an evaluation scale of 0 to 100%, the second evaluation quantity is scaled to be within an evaluation scale of 0 to 100%, the two dimensional matrix comprises a two-dimensional coordinate system, and the evaluation pair comprises a point in the two-dimensional coordinate system. The Examiner finds that “[t]he memory of SPICKERMANN is fully capable of storing a two-dimensional matrix of evaluation pairs and that assigns to each evaluation pair a value corresponding to a required change in substituate rate” (Non-final 24), and “the combination of SPICKERMANN and KOPPERSCHMIDT or the combination of Appeal 2021-005458 Application 13/512,133 9 SPICKERMANN/KOPPERSCHMIDT/POLASCHEGG is fully capable of having the first evaluation quantity scaled to be within an evaluation scale of 0 to 100%, the second evaluation quantity scaled to be within an evaluation scale of 0 to 100%, the two-dimensional matrix comprising a two-dimensional coordinate system, and the evaluation pair comprising a point in the two-dimensional coordinate system” (Non-final 33).3 The Examiner states: “It has been held that the recitation that an element is ‘capable of’ performing a function or operable to perform does not teach away from prior art structure if the prior art has the same capability but only requires the ability to so perform. It does not constitute a limitation in any patentable sense. MPEP 2114.11.” (Non-final 24-25, 34). The Examiner, however does not point out where the Appellant’s claim 57 recites “capable of.” The Examiner also finds that Polaschegg “teaches where the use of a 0- 100% control matrix, as claimed, or a polynomial calculation, as taught by SPICKERMANN, are known equivalents in the art of controlling a hemodialysis apparatus” (Non-final 34), and then cites to Polaschegg (Non- final 34). The Examiner, however, does not establish that the cited portion of Polaschegg discloses or would have suggested, to one of ordinary skill in the art, the above-stated claim requirements of a first evaluation quantity scaled to be within an evaluation scale of 0 to 100%, a second evaluation quantity scaled to be within an evaluation scale of 0 to 100%, a two dimensional matrix comprising a two-dimensional coordinate system, and an evaluation pair comprising a point in the two-dimensional coordinate system. 3 A discussion of Kopperschmidt is not necessary to our decision. Appeal 2021-005458 Application 13/512,133 10 CONCLUSION The Examiner has not set forth a factual basis that is sufficient to support a conclusion of obviousness of the Appellant’s claimed apparatus. See In re Warner, 379 F.2d 1011, 1017 (CCPA 1967) (“A rejection based on section 103 clearly must rest on a factual basis, and these facts must be interpreted without hindsight reconstruction of the invention from the prior art”). Accordingly, we reverse the rejections. DECISION SUMMARY In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 31, 58, 60- 63 103(a) Spickermann, Polaschegg 31, 58, 60- 63 35, 40, 57 103(a) Spickermann, Polaschegg, Kopperschmidt 35, 40, 57 Overall Outcome 31, 35, 40, 57, 58, 60- 63 REVERSED