Ex Parte Krause et alDownload PDFPatent Trial and Appeal BoardOct 31, 201714850404 (P.T.A.B. Oct. 31, 2017) Copy Citation 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. 14/850,404 09/10/2015 Bernd Krause 3724361-00190 9621 29178 7590 K&L Gates LLP-Gambro P.O.BOX 1135 CHICAGO, IL 60690-1135 EXAMINER MELLON, DAVID C ART UNIT PAPER NUMBER 1777 NOTIFICATION DATE DELIVERY MODE 11/02/2017 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 BERND KRAUSE, HERMANN GOHL, MARKUS HORNUNG, and CARINA ZWEIGART Applicant-Appellant'. GAMBRO LUNDIA AB.1 Appeal 2016-007892 Application 14/850,404 Technology Center 1700 Before CHUNG K. PAK, CHRISTOPHER L. OGDEN, and CHRISTOPHER C. KENNEDY, Administrative Patent Judges. OGDEN, Administrative Patent Judge. DECISION ON APPEAL Appellant appeals under 35 U.S.C. § 134(a)2 from the Examiner’s decision rejecting claims 1—7 in the above-identified application.3 We have jurisdiction pursuant to 35 U.S.C. § 6(b). We AFFIRM. 1 The Appeal Brief identifies Appellant Gambro Lundia AB as the real party in interest. See Appeal Br. 2, May 17, 2016. 2 Appeal Br.; Reply Br., Aug 16, 2016. 3 Final Office Action, February 23, 2016 [hereinafter Final Action]; Examiner’s Answer, July 15, 2016 [hereinafter Answer], Appeal 2016-007892 Application 14/850,404 BACKGROUND Appellant’s invention “concerns a semi-permeable hollow fiber membrane having an outer wall surface, an inner wall surface and an interior lumen extending along the length thereof,” and in particular, “a membrane having [a] selective layer on the outer wall surface.” Spec.412. Claim 1, the sole independent claim, is representative: 1. A microdialysis device comprising: a sensor membrane for direct blood applications, the sensor membrane being a semipermeable hollow fiber membrane comprising an outer wall surface being smooth, continuous, and homogeneous in a nanoscopic scale, an inner wall surface, and an interior lumen extending along the length of the semipermeable hollow fiber membrane, the semipermeable hollow fiber membrane having a selective layer on the outer wall surface, the outer wall surface having a smallest pore size and being virtually devoid of roughness with roughness parameters Ra and Rq of not more than 10 nm, roughness being measured with an atomic force microscope (AFM), and the roughness parameters Ra and Rq being calculated using the following equations: with N being the total number of data points and Zi being the height of a data point above an average picture level. Appeal Br. 11. 4 Specification, Oct. 15, 2015 (hereinafter Spec.). 2 Appeal 2016-007892 Application 14/850,404 The Examiner maintains the following grounds of rejection:5 1. Claims 1—3 and 5—7 are rejected under 35 U.S.C. § 103(a) as being unpatentable over Gorsuch6 in view of Kurth7 and in view of Kissinger.8 See Final Action 3—6. 2. Claim 4 is rejected under 35 U.S.C. § 103(a) as being unpatentable over Gorsuch in view of Kurth and Kissinger, and further in view of Kozawa,9 in light of additional evidence provided by Hajikano.10 See Final Action 6—7. In the Appeal Brief, Appellant argues claims 1,3, and 5—7 as a group, and provides a separate argument for dependent claim 2. See Appeal Br. 5— 9. Appellant provides no distinct argument with regard to dependent claim 4. See id. at 9. Therefore, consistent with 37 C.F.R. § 41.37(c)(l)(iv), we limit our discussion to claims 1 and 2. Claims 3—7 stand or fall with claim 1. DISCUSSION Claim 1 The Examiner finds that Gorsuch discloses a semipermeable hollow fiber membrane, used in one embodiment for dialysis processes, comprising every limitation of claim 1 except that Gorsuch does not specifically disclose (1) that the recited roughness parameters Ra and Rq are not more than 10 nm, 5 In the Answer, the Examiner withdrew two nonstatutory double patenting rejections. See Answer 6. 6 Gorsuch et al., US 6,802,820 B1 (issued Oct. 12, 2004). 7 Kurth et al., US 2003/0141242 Al (published July 31, 2003). 8 Kissinger, US 5,706,806 (issued Jan. 13, 1998). 9 Kozawa et al., US 6,355,730 B1 (issued Mar. 12, 2002). 10 Hajikano et al., US 6,284,137 B1 (issued Sept. 4, 2001). 3 Appeal 2016-007892 Application 14/850,404 or (2) use of the hollow fiber membrane in a microdialysis device. See Final Action 3—5. However, the Examiner finds that Kurth teaches that surface roughness is a factor that influences fouling propensity, and provides an example surface roughness of 3.25 nm for an ultrafiltration membrane. Id. at 4 (citing Kurth H 81, 165). The Examiner determines that a person of ordinary skill in the art, in light of these teachings, would have had reason to optimize the surface roughness in Gorsuch’s hollow fiber device in order to minimize fouling. Id. at 4—5. The Examiner also finds that Kissinger describes a microdialysis probe using a hollow fiber membrane made of polysulfone. Id. at 5 (citing Kissinger 3:25—40, claims 7, 8). (We note that Gorsuch teaches polysulfone as the preferred membrane material, see Gorsuch 4:62, and Appellant’s claim 3 recites polysulfone as a polymer composition for the membrane, see Appeal Br. 11.) Thus, the Examiner concludes, It would have been obvious to the ordinary artisan at the time of the invention to have adapted the Gorsuch hollow fiber mem brane for use in a microdialysis application as taught by Kissin ger for the purpose of providing for a suitable hollow fiber mem brane used in its intended purpose and to allow for surgical im plantation and treatment of a patient using the membrane. Answer 5. Appellant argues that the Gorsuch hollow fiber membrane relies, for its principle of operation, on the use of four different radial zones around the axis of the fiber, each zone having different properties including pore size. See Appeal Br. 7. According to Appellant, Kurth relates instead to nanofiltration (NF) or reverse (RO) membranes, which according to Kurth, “are most often regarded as not containing recognizable pores.” Id. (quoting Kurth 14). Appellant argues that “[o]ne of ordinary skill in the art would 4 Appeal 2016-007892 Application 14/850,404 not have been motivated to modify Gorsuch s membrane with features that would have resulted in non-recognizable pore sizes.” Id. Thus, according to Appellant, the pores in Kurth’s membrane “would be too small for dialysis applications,” and Kurth’s membrane “would not have been appropriate for Gorsuch s purpose of in-vivo dialysis.” Id.', see also Reply Br. 2. These arguments do not persuade us of reversible error in the Examiner’s rejection. As the Examiner notes in the Answer, the rejection cites Kurth solely for its surface roughness teaching. See Answer 7. The issue is what Kurth, in combination with Gorsuch, would have suggested to a person of ordinary skill in the art, not whether Kurth’s structure may be bodily combined with the structure disclosed in Gorsuch. See In re Keller, 642 F.2d 413, 425 (CCPA 1981). Kurth teaches that surface roughness affects the fouling propensity of the membrane surface. See Kurth 181. Surface roughness, therefore, was known to be a result effective variable at the time Appellant’s application was filed. See In re Applied Materials, Inc., 692 F.3d 1289, 1297 (Fed. Cir. 2012) (“A recognition in the prior art that a property is affected by the variable is sufficient to find the variable result- effective.”) Therefore, a person of ordinary skill in the art would have had reason to optimize the surface roughness parameters such that they are within the range recited in claim 1. On this record, we find no evidence that optimizing the surface roughness parameters would have required more than ordinary skill in the art at the time Appellant filed the application. See In re Boesch, 617 F.2d, 272, 276 (CCPA 1980) (“[Djiscovery of an optimum value of a result effective variable ... is ordinarily within the skill of the art.”). Contrary to Appellant’s arguments, Kurth’s teachings are not limited to membranes for 5 Appeal 2016-007892 Application 14/850,404 nanofiltration or reverse osmosis. Kurth states that “the polymer molecules constituting the matrix may be formed into microporous or ultraporous coatings that may function as microfiltration or ultrafiltration membranes.” Kurth 173. Kurth also teaches an ultrafiltration membrane with a surface roughness of 3.25 nm. See Kurth 1165. For the above reasons, we find no reversible error in the Examiner’s conclusion that it would have been an obvious variation over the prior art to select the surface roughness parameters as recited in claim 1. Appellant also argues that a skilled artisan would not have used Gorsuch’s ultrafiltration membrane in a microdialysis device, as microdialysis relies on diffusive transport of analytes across the membrane, whereas ultrafiltration relies on convective transport of a liquid. See Appeal Br. 8; see also Reply Br. 2—3. Thus, according to Appellant, using Gorsuch’s ultrafiltration membrane for microdialysis would change the principle of operation of the prior art device, and make it unsuitable for its intended purpose. See id. We find these arguments unpersuasive of reversible error because, as the Examiner notes in the Answer, Gorsuch teaches that a person may use the disclosed hollow fiber membrane for dialysis, which—like microdialysis—involves diffusive transport. See Answer 8 (citing Gorsuch 5:55—6:10). Therefore, the preponderance of the evidence on this record supports the Examiner’s conclusion that it would have been obvious to use the hollow fiber membrane of Gorsuch, as modified by Kurth, in a microdialysis device as taught by Kissinger. For the above reasons, we affirm the Examiner’s rejections of claims 1 and 3—7. 6 Appeal 2016-007892 Application 14/850,404 Claim 2 Claim 2 depends from claim 1, adding the limitation that “the semipermeable hollow fiber membrane has a hydraulic permeability within the range of 1*10-4 to 100* 10”4 [cm3/cm2xbarxs].” Appeal Br. 11 (bracketed material in original). The Examiner determines that “the membrane of Gorsuch as modified [by Kurth and Kissinger] will inherently provide a hydraulic permeability within the claimed range. In the alternative, it would have been obvious to modify and optimize the hydraulic permeability to improve membrane performance without compromising durability.” Final Action 5. According to Examiner, optimizing for this permeability range would have been within the skill in the art, and Appellant has not established that this range would provide an unexpected result. See id. Appellant argues that the specification demonstrates attendant advantages of the spe cifically claimed hydraulic permeability. In this regard, the spec ification teaches that, with the claimed hydraulic permeability, the convective transport through the membrane wall is mini mized at the same time having high diffusive transport in a broad range with respect to the molecular size (up to 100,000 Dalton depending on the fluid and measurement condition) or shape of the molecule. The attendant advantage of the specifically claimed hydraulic permeability is not even suggested by Gor such, Kurth, and Kissinger.'1'’ Appeal Br. 8—9. Appellant has the burden to establish unexpected results. See In re Geisler, 116 F.3d 1465, 1469-70 (Fed. Cir. 1997). However, Appellant has only provided the general description of an advantage, without showing (1) that the evidence of the advantage is reasonably commensurate with the 7 Appeal 2016-007892 Application 14/850,404 scope of the claim, see In re Harris, 409 F.3d 1339, 1343 (Fed. Cir. 2005); (2) that the closest prior art does not exhibit the advantage, see In re Baxter TravenolLabs., 952 F.2d 388, 392 (Fed. Cir. 1991); or (3) that the advantage was unexpected at the time of Appellant’s filing, see In re Klosak, 455 F.2d 1077, 1080 (CCPA 1972). Thus, on this record, Appellant has not shown persuasive evidence of unexpected results, and has not shown reversible error in the Examiner’s rejection of claim 2. Therefore, we affirm the Examiner’s rejection of claim 2. DECISION The Examiner’s decision is affirmed. No time period for taking any subsequent action in connection with this appeal maybe extended. See 37 C.F.R. § 1.136(a)(l)(iv) (2016). AFFIRMED 8 Copy with citationCopy as parenthetical citation