Ex Parte Vicalvi et al

Patent Trials and Appeals BoardMar 22, 2019

13825829 - (D) (P.T.A.B. Mar. 22, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE FIRST NAMED INVENTOR 13/825,829 04/01/2013 John J. Vicalvi 123162 7590 03/26/2019 GE Healthcare - Grogan, Tuccillo & V anderleeden LL 1350 Main Street, 5th Floor Springfield, MA 01103 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. 266914-6 X 10128 US 9294 EXAMINER ORME, PATRICK JAMES ART UNIT PAPER NUMBER 1779 NOTIFICATION DATE DELIVERY MODE 03/26/2019 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): docket@gtv-ip.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte JOHN J. VI CAL VI, JOSEPH MAKO WIECK.I, JOSEPH D. CROWELL, and PARRISH M. GALLIHER Appeal2018-003984 Application 13/825,829 Technology Center 1700 Before ROMULO H. DELMENDO, CHRISTOPHER C. KENNEDY, and DEBRA L. DENNETT, Administrative Patent Judges. DELMENDO, Administrative Patent Judge. DECISION ON APPEAL The Applicant ("Appellant") 1 appeals under 35 U.S.C. Â§ 134(a) from the Primary Examiner's final decision to reject claims 1-24. 2 We have jurisdiction under 35 U.S.C. Â§ 6(b). We affirm-in-part. 1 The Appellant is the Applicant, GE Healthcare Bio-Sciences Corp. (Application Data Sheet filed April 26, 2016, 5), which, according to the Brief, is the real party in interest (Appeal Brief filed October 2, 2017 ("Appeal Br."), 2). 2 See Appeal Br. 5-21; Reply Brief filed March 2, 2018 ("Reply Br."), 5-9; see also Final Office Action entered February 2, 2017 ("Final Act."), 7-27; and Examiner's Answer entered January 2, 2018 ("Ans."), 2-12. Appeal2018-003984 Application 13/825,829 I. BACKGROUND The subject matter on appeal relates to systems and methods for chromatography (Specification filed March 25, 2013 ("Spec."), ,r 1; Abstract). Figure 2 (Drawings filed March 25, 2013; some annotations added) is reproduced, as follows: SYSTEM CWTROLLER GAS OR VA.C:UUM .4-1'!--"'t"":' SOURCE ill F!G. 2 Figure 2 above is a schematic view depicting a disposable chromatography system 200 operating in a slurried bed mode according to the invention, wherein the system 200 includes, inter alia, a flexible container 102, a support structure 104, an inlet port 106, an outlet port 108, a separation device in the form of a frit filter 110 containing a nozzle 206 for passing "high velocity mobile phase" pumped by an external pump to fluidize the slurried bed (packing material 202), and a rigid distributor plate 134 (Spec. ,r,r 14, 15, 24, and 28). 2 Appeal2018-003984 Application 13/825,829 Representative claim 1 is reproduced from the Claims Appendix to the Appeal Brief, as follows: 1. A disposable particulate slurry chromatography system, compnsmg: a flexible container configured to fit within a support structure and adapted to receive a particulate slurry filtration medium, the flexible container comprising: at least one inlet; at least one outlet; a separation barrier peripherally sealed within the container to separate the container into a filtration portion and a drainage portion, the separation barrier including a nozzle; a rigid distributor plate that supports the separation barrier; and wherein the separation barrier retains the filtration medium separately from the drainage portion during use while allowing fluids to pass therethrough, and the nozzle allows a high velocity mobile phase, pumped via an external pump, to fluidize the filtration medium via dislodging at least some of the filtration medium. (Appeal Br. 22, Claims App. (emphasis added)). Claims 11, 19, and 24, the only other independent claims on appeal, also recite similar nozzle limitations (id. at 24--27). II. REJECTIONS ON APPEAL On appeal, the Examiner maintains multiple rejections under various pre-AIA statutory provisions, as follows: A. Claims 1-24 under 35 U.S.C. Â§ 112, ,r 2, as indefinite; B. Claims 1, 6, 10, 11, 19, 23, and 24 under 35 U.S.C. Â§ 103(a) as 3 Appeal2018-003984 Application 13/825,829 unpatentable over Allen et al. 3 ("Allen") in view of Gebauer; 4' 5 C. Claims 2-5, 7, and 9 under 35 U.S.C. Â§ I03(a) as unpatentable over Allen in view of Gebauer and further in view of Lihme et al. 6 ("Lihme") and Fernando; 7 D. Claims 8 and 18 under 35 U.S.C. Â§ 103(a) as unpatentable over Allen and Gebauer and further in view of Lihme; E. Claim 12 under 35 U.S.C. Â§ I03(a) as unpatentable over Allen and Gebauer and further in view of Ralph L. Shriner et al. (eds.), The Systematic Identification of Organic Compounds: A Laboratory Manual, 376, 379-80, 383,387, 6th ed. 1979 ("Shiner"); F. Claims 13, 14, and 17 under 35 U.S.C. Â§ I03(a) as unpatentable over Allen, Gebauer, and Shriner and further in view of Lihme and Fernando; G. Claims 15 and 16 under 35 U.S.C. Â§ I03(a) as unpatentable over Allen, Gebauer, Shriner, Lihme, and Fernando, and further 3 US 2002/0166816 Al, published November 14, 2002. 4 US 2008/0217248 Al, published September 11, 2008. 5 In the Final Action (Final Act. 9-10), the Examiner also relies on McDonald et al. ("McDonald"), US 4,250,035, issued February 10, 1981, which Allen incorporates by reference for a disclosure on a pressurized fluid providing radial compression to a flexible wall to close voids in and provide uniform packing of resin beads in a chromatography column's stationary phase (Allen ,r,r 3, 17). 6 US 6,620,326 B 1, issued September 16, 2003. 7 US 2010/0107752 Al, published May 6, 2010. 4 Appeal2018-003984 Application 13/825,829 in view of Lauer et al. 8 ("Lauer"); H. Claims 20 and 21 under 35 U.S.C. Â§ 103(a) as unpatentable over Allen and Gebauer and further in view of Lihme and Fernando; and I. Claim 22 under 35 U.S.C. Â§ 103(a) as unpatentable over Allen and Gebauer and further in view of Lihme. (Ans. 2-12; Final Act. 3-27.) III. DISCUSSION Rejection A. Regarding the four independent claims on appeal (namely, claims 1, 11, 19, and 24), the Examiner states that the term "high" in the recitation "high velocity" is a relative term for which no standard for ascertaining the requisite degree is provided in either the claims or the accompanying description in the Specification (Final Act. 8). Regarding claim 17, which depends on claim 11 through intervening claims 14, 13, and 12, the Examiner states that "the at least one probe" lacks sufficient antecedent basis (id.). The Appellant contends that the term "high" in claims 1, 11, 19, and 24 does not render the claims indefinite because the Specification and Drawings reasonably apprise one skilled in the relevant art that the recitation "high velocity" refers to a mobile phase velocity through the nozzle sufficient to dislodge and fluidize the filtration medium (Appeal Br. 18). Regarding the recitation "the at least one probe" in claim 17, the Appellant does not offer any substantive argument but instead concedes that the claim contains a typographical error in that the claim should have been drafted to 8 US 3,539,505, issued November 10, 1970. 5 Appeal2018-003984 Application 13/825,829 depend from claim 16--not claim 14 (id.). According to the Appellant, the error "is readily addressable post-appeal via an Examiner's amendment or Ex Parte Quayle Action" (id. at 19). 1. Claims 1, 11, 19, and 24 The test for indefiniteness is whether the claim, when read in light of the specification, reasonably apprises one skilled in the art of its scope. In re Warmerdam, 33 F.3d 1354, 1361 (Fed. Cir. 1994). "Claim language employing terms of degree has long been found definite where it provided enough certainty to one of skill in the art when read in the context of the invention." Interval Licensing LLC v. AOL, Inc., 766 F.3d 1364, 1370 (Fed. Cir. 2014). We agree with the Appellant that the term "high," when read in the context of the claims and the Specification, does not render the claims indefinite. For example, claim 1 itself recites that "the nozzle allows a high velocity mobile phase ... to fluidize the filtration medium via dislodging at least some of the filtration medium" (Appeal Br. 22, Claims App.). One skilled in the relevant art would understand from the claim itself and the remainder of the Specification (e.g., Spec. ,r 24) that for a given nozzle size, the velocity created by the external pump is sufficiently high such that at least some of the filtration medium is dislodged to cause fluidization. Thus, contrary to the Examiner's position, the Specification, which includes claim 1, reasonably apprises one skilled in the relevant art a standard for determining whether a nozzle velocity is "high." Although the claim language's scope is arguably broad as the filtration medium, the nozzle size, and the pump capacity are not limited, "[b ]readth is not indefiniteness." In re Gardner, 427 F.2d 786, 788 (CCPA 1970). 6 Appeal2018-003984 Application 13/825,829 2. Claim 17 Because claim 17 has not been amended to correct the typographical error or argued on the merits as to the indefiniteness issue, we summarily affirm the rejection as maintained against this claim. Cf Hyatt v. Dudas, 551 F.3d 1307, 1314 (Fed. Cir. 2008) ("In the event of ... a waiver, the [Board] may affirm the rejection ... without considering the merits."). Rejections B--1. Regarding the independent claims on appeal (claims 1, 11, 19, and 24 ), the Examiner finds that Allen describes most of the limitations recited in these claims but acknowledges that the reference does not disclose a nozzle ( or use thereof) as specified in the claims (Final Act. 9- 10, 11-12, 13-14, and 15-16). The Examiner finds, however, that "Gebauer ... discloses a nozzle ... and the nozzle allows a high velocity mobile phase, pumped via an external pump, to fluidize the filtration medium via dislodging at least some of the filtration medium" (id. at 10 (citing Gebauer, Fig. 2 and ,r 62); see also Final Act. 12, 14, and 16). The Examiner concludes from these findings that "[i]t would have been obvious to one of ordinary skill in the art ... to combine the system disclosed by Allen with the nozzle disclosed by Gebauer because, according to Gebauer, the nozzle facilitates distribution and even packing of the slurry with the bed space" (Final Act. 11; see also id. 13, 14, and 16). The Appellant contends that Allen does not disclose a flexible container adapted to receive a particulate slurry filtration medium as recited in, e.g., claim 1, but, instead, a solid monolithic filter (Appeal Br. 6-7). The Appellant argues, inter alia, that because Allen teaches a solid monolith filter, any nozzle placed on a separation barrier as required by the claims would be incapable of fluidizing the solid monolith (id. at 10). Furthermore, 7 Appeal2018-003984 Application 13/825,829 the Appellant argues that a person having ordinary skill in the art would not have been prompted to include Gebauer's nozzle on Allen's outlet manifold, which has been found to correspond to the "separation barrier" (e.g., a frit filter (Spec. ,r 24)) recited in the claims, as the nozzle would be below the solid monolith and, thus, incapable of fluidizing any particulates (Appeal Br. 10). We concur with the Appellant because the rejection fails to articulate a sufficient reason with some rational underpinning that would have prompted a person having ordinary skill in the art to combine Allen and Gebauer in the manner claimed by the Inventors. In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006), cited in KSR Int 'l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007). Allen's Figure 2 (annotated) is reproduced as follows: cartridge 16 \ 21 vessei (flexible waii) ::< ,-14 pressure chamber FIG. 2 28bottom plate 24 oL,tlet manifo!d 8 Appeal2018-003984 Application 13/825,829 Allen's Figure 2 above depicts a sectional view showing a chromatography apparatus for separating a chemical contained in a solution, wherein the apparatus includes, inter alia: a cartridge 16 including a flexible-walled, cylindrical vessel 21 that receives a plug-shaped monolith chromatography stationary phase 20; an inflow line 32; an outlet line 34; an outlet manifold 24; and a bottom plate 28 (Allen ,r,r 16-17). Allen teaches that the monolith stationary phase 20 may be "formed in place in flexible vessel 21" (id. ,r 18). According to the Examiner, the outlet manifold 24 corresponds to the "separation barrier peripherally sealed within the container to separate the container into a filtration portion and a drainage portion" as recited in claim 1 (Final Act. 10). As the Examiner acknowledges, however, Allen's outlet manifold does not include a nozzle, let alone a "nozzle [that] allows a high velocity mobile phase, pumped via an external pump, to fluidize the filtration medium via dislodging at least some of the filtration medium" (id.). In discussing other prior art, Allen identifies McDonald as disclosing that "[i]t is known to compress flexible-walled columns (also referred to as cartridges) in order to close voids and provide uniform packing of the resin beads of the stationary phase" (Allen ,r 3). Allen states that "[b]ecause [its] stationary phase is provided as [a] unitary structure, it will not suffer from the shifting of individual particles as can happen with the resin beads" used in the prior art (id. ,r 4 ). Allen also incorporates by reference McDonald for a teaching on using a pressurized liquid for radially compressing vessel 21 's flexible wall (id. ,r 17; see also, e.g., McDonald col. 4, 11. 20-48). 9 Appeal2018-003984 Application 13/825,829 Gebauer's Figure 2 (partially annotated) is reproduced as follows: 101-~ \ cof1...Hrin \â€¢ i33 j' '--140 r. .. :.-i Â·34!] (