Ex Parte Conlisk et alDownload PDFPatent Trial and Appeal BoardMar 24, 201713195774 (P.T.A.B. Mar. 24, 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. 13/195,774 08/01/2011 Albert Terrence Conlisk JR. OSU1159-260C 2547 8698 7590 03/28/2017 STANDLEY LAW GROUP LLP 6300 Riverside Drive Dublin, OH 43017 EXAMINER SASS, SARA A ART UNIT PAPER NUMBER 3761 NOTIFICATION DATE DELIVERY MODE 03/28/2017 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): standley docketing @ standleyllp.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte ALBERT TERRENCE CONLISK JR., SUBHRA DATTA, WILLIAM H. FISSELL, and SHUVO ROY1 Appeal 2015-006061 Application 13/195,774 Technology Center 3700 Before DONALD E. ADAMS, JEFFREY N. FREDMAN, and TIMOTHY G. MAJORS, Administrative Patent Judges. PER CURIAM. DECISION ON APPEAL This is an appeal under 35U.S.C. § 134 involving claims that have been rejected as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We reverse. 1 Appellants indicate that the real party in interest is The Ohio State University (subject to assignment), and that a confirmatory license to National Institutes of Health (NIH), U.S. Dept, of Health and Human Services (DHHS), and the U.S. Government NIH Division of Extramural Inventions and Technology Resources (DEITR) is recorded in USPTO records. (Br. 2.) Appeal 2015-006061 Application 13/195,774 STATEMENT OF THE CASE Appellants’ invention relates to “ultrafiltration, and more particularly . . . selective filtration of charged/uncharged molecules potentially in biomedical and related applications.” (Spec. 12.) Claims 2—6, 8—20, 22, and 23 are on appeal. Claim 22 is illustrative: 22. A device for selective ultrafiltration of a fluid containing molecules of first and a second solute, by selectively retaining the first solute while passing the second solute, comprising: a housing; a main filtration chamber inside the housing; an inlet port passing through the housing configured to receive the fluid; an outlet port passing through the housing configured to return the fluid to a feed flow; an ultrafiltration membrane contained in the main filtration chamber to divide the main filtration chamber into at least two interior chambers, a first of the at least two interior chambers being a feed chamber to contain the fluid and a second of the at least two chambers being a permeate chamber, the ultrafiltration membrane comprising pores sized to allow passage of the similarly-sized molecules and establish a sieving coefficient for each of the first and second solutes across the ultrafiltration membrane; and a permeate solution, contained in the permeate chamber, the permeate solution comprising an additive solute that is selected so that the presence of the additive solute in the permeate solution decreases the sieving coefficient of the first solute across the ultrafiltration membrane relative to the sieving coefficient of the second solute across the ultrafiltration 2 Appeal 2015-006061 Application 13/195,774 membrane, while the pores render the membrane substantially impermeable to the additive solute. (Br. 17—18 (Claims App’x).) The claims stand rejected as follows: I. Claims 2—6, 8—20, and 22 under 35 U.S.C. § 103(a) over Fissell.2 II. Claim 23 under 35 U.S.C. § 103(a) over Fissell and Ross.3 DISCUSSION REJECTIONS I AND II These rejections rely upon the Fissell reference, and so we focus on the Examiner’s findings with respect to this reference. Appellants’ independent claim 22 recites, among other things, a permeate solution, contained in the permeate chamber, the permeate solution comprising an additive solute that is selected so that the presence of the additive solute in the permeate solution decreases the sieving coefficient of the first solute across the ultrafiltration membrane relative to the sieving coefficient of the second solute across the ultrafiltration membrane, while the pores render the membrane substantially impermeable to the additive solute. Independent claim 17 includes a similar limitation. (Br. 17—18 (Claims App’x).) The Examiner finds that Fissell teaches a device for selective ultrafiltration of a fluid containing molecules of first and second solute (column 2, lines 2 Fissell, IV et al., US 7,048,856 B2, issued May 23, 2006. 3 Ross, US 2002/0115956 Al, published Aug. 22, 2002. 3 Appeal 2015-006061 Application 13/195,774 2-4, column 8, lines 52—57), by selectively retaining the first solute as antibodies (column 2, lines 6—7) while passing the second solute as beta 2 micro globulin (column 2, line 8), comprising: a housing 10 (column 12, lines 55—57), a main filtration chamber compartment (column 12, lines 50—55) inside the housing 10, an inlet port/opening entry 602 (column 13, lines 11-15) passing through the housing 10 configured to receive the fluid (column 13, lines 20-25), an outlet port/exit means on the 600 side (column 13, lines 17—13) passing through the housing 10 (column 12, lines 55—57) configured to return the fluid to a feed flow as exit of feed fluid (column 13, line 1, Figure 3); and an ultrafiltration membrane 201 (column 9, lines 34—36, column 10, lines 24—25) contained in the main filtration chamber/compartment to divide the main filtration chamber into at least two interior chambers/sub-compartments 700, 702 (column 12, lines 49—55), a first of the at least two interior chambers being a feed chamber/first sub-compartment 700 to contain the fluid (column 12, line 67) and a second of the at least two chambers being a permeate chamber/second sub compartment 702 (column 13, lines 5—8), the ultrafiltration membrane 201 comprising pores capable of separating middle molecules (column 10, lines 25—27, 34—36, Figure 3). Fissell further teaches a permeate solution (column 13, line 8), contained in the permeate chamber/second sub-compartment (column 13, lines 5—8), the permeate solution comprising an additive solute as a dialyzing fluid (column 13, line 10) coming through 102 (Figure 3), selected with regard to both the selected solute and the ultrafiltration membrane 201 because it is incorporated into the feed fluid (column 13, lines 10-11), such that the pores render the membrane 201 substantially impermeable to the additive because the pores can be adjusted to be impermeable to various blood components (column 3, lines 50-54, 60-65, Figure 3). (Ans. 3-4.) The Examiner finds that Fissell fails to teach [that] the presence of the additive solute/dialyzing fluid (column 13, line 10) in the permeate solution (column 13, line 8) decreases the sieving coefficient of 4 Appeal 2015-006061 Application 13/195,774 the first solute across the ultrafiltration membrane relative to the sieving coefficient of the second solute across the ultrafiltration membrane, and that a sieving coefficient is established for each of the first and second solutes across the ultrafiltration membrane, because Fissell doesn’t specifically teach a sieving coefficient. (Id. at 4.) The Examiner finds that Fissell teaches [that] the presence of the additive solute/dialyzing fluid (column 13, line 10) in the permeate solution (column 13, line 8) and of different solutes in permeate solution allows for complete control over parameters (column 9, lines 22—25) that would determine permeate side and feed side values for solute diffusion during hemofiltration (column 14, lines 1—2). Additionally, Fissell teaches a system that permits complete manipulation of parameters to control exclusion of molecules with particular properties (column 9, lines 22—25) which would be necessary for hemofiltration (column 14, lines 1—2), diagnostic uses (column 15, lines 63—65), bioreactors (column 16, line 42), bioartificial organs (column 16, lines 64—66), surfaces (column 17, lines 35—36), cells (column 18, lines 20- 24) all of which would require different solutes filtered and maintained from the feed fluid by the membrane for their specific application as is known in the art, and thus sieving coefficients as defined are disclosed. Also, Fissell teaches large molecules are blocked by the membrane (column 2, lines 6—8) and that smaller molecules, such as the second solute, beta 2 microglobulin (column 2, lines 7-10) are let through due to their danger in accumulating for the risk of renal failure (column 2, lines 10-13). (Id. at 4—5.) The Examiner asserts that [t]he blockage of the first solute, and the allowance of the second solute, would mean that there would be less receiving stream for the sieving coefficient for the first solute, and greater receiving stream for the sieving coefficient for the second solute. This 5 Appeal 2015-006061 Application 13/195,774 would create a decreased sieving coefficient of the first solute across the ultrafiltration membrane relative to the sieving coefficient of the second solute across the ultrafiltration membrane. Sieving coefficient = S = Cr / Cd Cr = mean concentration mass receiving stream (first/second solutes after membrane) Cd = mean concentration mass donating stream (flow prior to membrane) S (antibodies) < S (beta 2 microglobulin) because mass receiving stream of antibodies is blocked. S (first solute) < S (second solute). (Id. at 5—6.) The Examiner concludes that it would have been obvious to derive from Fissell’s disclosure of particular solutes traveling across the ultrafiltration membrane as contributing to the sieving coefficient values, especially since Fissell is teaching various components of the system are controlled depending on the situation in which it is used. The large and small molecule blocking and allowance described above makes the sieving coefficient condition recited in the claim obvious over Fissell after the mathematics, as demonstrated above, are performed. (Id.) A prima facie case of obviousness “requires a suggestion of all limitations in a claim,” CFMT, Inc. v. Yieldup Int’l Corp., 349 F.3d 1333, 1342 (Fed. Cir. 2003) and “a reason that would have prompted a person of ordinary skill in the relevant field to combine the elements in the way the claimed new invention does.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007). 6 Appeal 2015-006061 Application 13/195,774 We are not persuaded that the Examiner has met the burden to establish by a preponderance of the evidence that claims 22 and 17 would have been obvious. Instead, we agree with Appellants that [a] major contention of the applicant in this prosecution has been that claim 22 requires a “permeate solution, contained in the permeate chamber,” with an “additive solute” selected “so that the presence of the additive solute in the permeate solution selectively decreases the sieving coefficient of the first solute across the ultrafiltration membrane relative to the sieving coefficient of the second solute across the ultrafiltration membrane, while the pores render the membrane substantially impermeable to the additive solute.” The Patent Office maintains that a “third fluid” that is a “dialyzing fluid for the feed fluid” (both quotes from Fissell ‘856, Col 13, line 10) is qualified as the additive solute. The Patent Office has failed to establish in a documented fashion that one of skill would consider a generic term like “dialyzing fluid” to carry with it the express requirements of the claim. (Br. 8-9.) We recognize, but are not persuaded by, the Examiner’s assertion that [t]he additive solute in the dialyzing fluid for the feed fluid taught by Fissell is added for optimal fluid composition delivery in the system taught by Fissell. See column 13, line 10. Fissell teaches the presence of the additive solute/dialyzing fluid (column 13, line 10) in the permeate solution (column 13, line 8) and of different solutes in permeate solution allows for complete control over parameters (column 9, lines 22—25) that would determine permeate side and feed side values for solute diffusion during hemofiltration (column 14, lines 1—2). (Ans. 15-16.) We also recognize, but are not persuaded by, the Examiner’s assertion that Examiner relied upon the one surface treatment of at least one pore taught by Fissell (column 4, lines 24—28) which can include 7 Appeal 2015-006061 Application 13/195,774 making the pores impermeable as is known in the art. This impermeability is obvious over Fissell since Fissell teaches the dialyzing fluid has its constituents remain with the feed fluid for an ultrafiltration of blood that supplies nutrients (Col 3, lines 20— 26) as cited in the rejection. (Id. at 19.) “Rejections on obviousness grounds cannot be sustained by mere conclusory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.” In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006). ft appears that the Examiner concludes that because “Fissell teaches the presence of the additive solute/dialyzing fluid (column 13, line 10) in the permeate solution (column 13, line 8) and of different solutes in permeate solution allows for complete control over parameters (column 9, lines 22—25)” (id. at 15—16), it would have been obvious to modify Fissell by controlling parameters so that “the pores render the membrane substantially impermeable to the additive solute” as claimed. The Examiner, however, did not adequately explain how or why the skilled artisan would have predictably, and with a reasonable expectation of success, modified Fissell in the manner suggested. Depuy Spine, Inc v. Medtronic Sofamor Danek, Inc., 567 F.3d 1314, 1326 (2009) (citations omitted) (“the ‘predictable result’ discussed in KSR refers not only to the expectation that prior art elements are capable of being physically combined, but also that the combination would have worked for its intended purpose.”). While Fissell might teach surface treatment of the membrane “to promote or retard attachment of specific cells and proteins” as the Examiner points out (Fissell 4:24-28; Ans. 19), we are unpersuaded this teaches or suggests the structure and function of the additive solute of the claims. 8 Appeal 2015-006061 Application 13/195,774 On the present record, we thus agree with Appellants that “Fissell ’856 does not do anything to characterize the additive solute in a manner that would allow one of skill in the art to identify an additive solute that would be reasonably certain to be successfully implemented.” (Br. 10). Accordingly, on this record, the Examiner failed to establish an evidentiary basis to support a conclusion that there was an advantage or reason to modify Fissell’s device so that “the pores render the membrane substantially impermeable to the additive solute” as required by claim 22, and similarly required by claim 17. For the reasons above, the rejection of independent claims 17 and 22 is reversed. The Examiner’s findings with respect to Ross, do not make up for the deficiencies of Fissell. We thus reverse the rejection of claim 23. CONCLUSION OF LAW We reverse the rejection of claims 2—6, 8—20, and 22 under 35 U.S.C. § 103(a) over Fissell. We reverse the rejection of claim 23 under 35 U.S.C. § 103(a) over Fissell and Ross. REVERSED 9 Copy with citationCopy as parenthetical citation