Ex Parte AlpertDownload PDFPatent Trial and Appeal BoardJul 15, 201311683812 (P.T.A.B. Jul. 15, 2013) Copy Citation UNITED STATES PATENT AND TRADEMARKOFFICE 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. 11/683,812 03/08/2007 Andrew J. Alpert 007162.00001 1559 22907 7590 07/16/2013 BANNER & WITCOFF, LTD. 1100 13th STREET, N.W. SUITE 1200 WASHINGTON, DC 20005-4051 EXAMINER THERKORN, ERNEST G ART UNIT PAPER NUMBER 1776 MAIL DATE DELIVERY MODE 07/16/2013 PAPER 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. PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte ANDREW J. ALPERT ____________ Appeal 2012-003530 Application 11/683,812 Technology Center 1700 ____________ Before BRADLEY R. GARRIS, CATHERINE Q. TIMM, and DONNA M. PRAISS, Administrative Patent Judges. GARRIS, Administrative Patent Judge. DECISION ON APPEAL Appeal 2012-003530 Application 11/683,812 2 Appellant appeals under 35 U.S.C. § 134 from the Examiner's decision rejecting claims 1, 3-5, 8, 9, 11, 15, 16, 18, and 20. We have jurisdiction under 35 U.S.C. § 6. We AFFIRM. Appellant claims a method of performing electrostatic repulsion- hydrophilic interaction chromatography on a compound selected from the group consisting of proteins, peptides, amino acids, and charged derivatives thereof which comprises providing a column having an anion-exchange material and eluting the compound using an amount of organic solvent sufficient to substantially balance the electrostatic repulsion of the stationary phase with hydrophilic interaction (independent claim 1; see also independent claim 16). Appellant also claims a similar method performed on not only the above recited compounds but also nucleic acids, nucleotides and charged derivatives thereof which comprises providing a column having an anion-exchange material or a cation-exchange material and eluting the compound as recited earlier (independent claim 9). A copy of representative independent claims 1 and 9, taken from the Claims Appendix of the Appeal Brief, is set forth below: 1. A method of performing electrostatic repulsion- hydrophilic interaction chromatography on a compound selected from the group consisting of proteins, peptides, amino acids, and charged derivatives thereof, the method comprising: providing a column having an anion-exchange material at a pH of less than about 4; and eluting the compound using a mobile phase comprising an amount of organic solvent sufficient to substantially balance the electrostatic repulsion of the stationary phase with hydrophilic interaction. Appeal 2012-003530 Application 11/683,812 3 9. A method of performing electrostatic repulsion- hydrophilic interaction chromatography on a compound selected from the group consisting of proteins, peptides, amino acids, nucleic acids, nucleotides, and charged derivatives thereof, the method comprising: providing a column having an anion-exchange material at a pH of less than about 4 or a cation-exchange material at a pH of less than about 3.4; and eluting the compound using a mobile phase comprising organic solvent sufficient to substantially balance the electrostatic repulsion of the stationary phase with hydrophilic interaction. The Examiner rejects independent claim 9 as well as dependent claims 11 and 15 under the 2nd paragraph of 35 U.S.C. § 112 as being misdescriptive and therefore indefinite, under the 1st paragraph of 35 U.S.C. § 112 as being non-enabled, and under 35 U.S.C. § 101 as being inoperative and therefore lacking utility (Ans. 6-11). The Examiner further rejects all appealed claims under the 2nd paragraph of 35 U.S.C. 112 as being indefinite, under 35 U.S.C. § 102(e) or § 103(a) as being anticipated by or alternatively as being unpatentable over Lindner (US 2008/0164211 A1, published Jul. 10, 2008) and under 35 U.S.C. § 103(a) as being unpatentable over Lindner in view of Alpert (Hydrophilic-Interaction Chromatography for the Separation of Peptides, Nucleic Acids and Other Polar Compounds, Journal of Chromatography, 499, 177-196 (1990)) alone or in combination with Hawley (US 2003/0166160 A1, published Sep. 4, 2003) (id. at 4-6, 11-15). Appellant does not present separate arguments directed to the dependent claims under rejection. Therefore, the dependent claims will Appeal 2012-003530 Application 11/683,812 4 stand or fall with the independent claims of which claims 1 and 9 are representative. The § 112 and § 101 Rejections of Claims 9, 11, and 15 We will sustain each of these rejections for the reasons given by the Examiner in the Answer. The following comments are added for emphasis. As an initial matter, we emphasize that each of these rejections is based on the Examiner's determination that claim 9 has been amended in such a way as to explicitly define non-enabled and inoperative embodiments wherein nucleic acids and nucleotides are eluted via anion-exchange material and wherein proteins, peptides, and amino acids are eluted via cation-exchange material. Significantly, this determination has not been disputed by Appellant in the record of this appeal. The § 112, 2nd paragraph, rejection is summarily sustained since Appellant does not contest it as pointed out by the Examiner (Ans. para. bridging 20-21). Contrary to Appellant's argument concerning the § 112, 1st paragraph, rejection, claim 9 does not satisfy the enablement requirement simply because the claim embraces enabled/operative as well as non- enabled/inoperative embodiments (App. Br. 7-8). "[I]n order to fulfill the enablement requirement, the specification must enable the full scope of the claims . . . ." Automotive Technologies Int’l, Inc. v. BMW of North America, Inc., 501 F.3d 1274, 1285 (Fed. Cir. 2007). As indicated above, Appellant does not dispute the Examiner's determination that claim 9 defines non-enabled and inoperative embodiments. Furthermore, these embodiments are explicitly defined by Appeal 2012-003530 Application 11/683,812 5 specific recitation rather than merely encompassed by broad language. It follows that we also sustain the § 112, 1st paragraph, rejection of claims 9, 11, and 15. Under the circumstances of this appeal, the issues presented by the § 112, 1st paragraph, rejection correspond to those presented by the § 101 rejection. See Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1359 (Fed. Cir. 1999) (“[A] claim containing a limitation impossible to meet may be held invalid under §112[, and], when a claim requires a means for accomplishing an unattainable result, the claimed invention must be considered inoperative as claimed and the claim must be held invalid under either §101 or §112 of 35 U.S.C.” quoting Raytheon Co. v. Roper Corp., 724 F.2d 951, 956 (Fed. Cir. 1983)). Therefore, we sustain the § 101 rejection of claims 9, 11, and 15 for reasons analogous to those expressed above. The § 112, 2nd paragraph, and § 102 Rejections of All Appealed Claims These rejections will be sustained for the reasons stated in the Answer and below. We agree with the Examiner that the appealed claims are rendered indefinite by the independent claim limitation "an amount of organic solvent sufficient to substantially balance the electrostatic repulsion of the stationary phase with hydrophilic interaction" (independent claim 1; see also independent claims 9 and 16). As correctly indicated by the Examiner, the Specification does not give sufficient guidance for determining when the required balance has been achieved because the paragraphs and figures Appeal 2012-003530 Application 11/683,812 6 relied upon by Appellant for this limitation "are devoid of any balancing measurement techniques" (Ans. 4). Appellant argues that the limitation "is supported by ample guidance in the specification, including description of types and amounts of organic solvents for achieving this effect in various systems" (App. Br. 5). However, Appellant fails to embellish this argument with an explanation of why the referenced Specification paragraphs and figures would provide an artisan with guidance for determining with reasonable precision the amount of solvent needed to "substantially balance the electrostatic repulsion of the stationary phase with hydrophilic interaction" as required by the independent claims. We emphasize that the claim term "substantially" is a word of degree and that the Specification must provide some standard for measuring such degree. See Seattle Box Co., Inc. v. Industrial Crating & Packing, Inc., 731 F.2d 818, 826 (Fed. Cir. 1984); see also Halliburton Energy Services, Inc. v. M-I LLC, 514 F.3d 1244, 1253 (Fed. Cir. 2008) (holding that the claim phrase "fragile gel" rendered the claims indefinite and stating that "[t]he fluids of the '832 invention may provide less resistance to sheer (i.e., break more quickly) than the prior art fluids, but the degree of improved speed remains ambiguous."). On this record, Appellant fails to identify any Specification disclosure which provides a standard for measuring the claim term "substantially" and concomitantly guidance for determining with reasonable precision an amount of solvent sufficient to "substantially balance" the electrostatic repulsion of the stationary phase with hydrophilic interaction. For this reason, we sustain the § 112, 2nd paragraph, rejection of all appealed claims. Appeal 2012-003530 Application 11/683,812 7 Concerning the §102 rejection, the Examiner finds that the requirements of claim 1 are satisfied by Example B4 of Lindner (Ans. 11- 13) and accordingly that the "recited repulsive electrostatic interaction inherently occurs because Lindner . . . uses the same eluents in the same manner and concentration, uses the same resin, and separates the same material at the same pH as appellant" (id. at 13). Appellant disputes the Examiner's inherency position by arguing that Lindner's discussion "of electrostatic repulsion effects at ¶¶ 0017, 0086, and 0088 . . . involves retention via hydrophobic interaction (HIC)" (App. Br. 9). Appellant has failed to establish that the electrostatic repulsion effects of Lindner are limited to hydrophobic interaction. For example, contrary to Appellant's implication, hydrophobic interaction is not mentioned in Lindner's paragraph [0086] discussion of electrostatic repulsion. Further, while Appellant's referenced paragraph [0088] of Lindner discloses "hydrophobic interaction chromatography/anion-exchange (HIC/AX) (or more precisely hydrophobic interaction chromatography/ion-exclusion chromatography)", this disclosure is immediately followed by reference to "hydrophilic interaction chromatography/anion-exchange (HILIC/AX)" (emphasis added). Appellant further argues that, "at the starting concentration 90% acetonitrile [of Lindner], hydrophilic interaction is so strong that the electrostatic effects are comparatively insignificant" (App. Br. 10) whereas "the present specification shows that such effects become significant on HILIC/WAX material at an acetonitrile concentration of 70% or less" (id.). Appeal 2012-003530 Application 11/683,812 8 Appellant’s argument fails to address much less dispute the Examiner's finding that the acetonitrile concentration of Lindner starts at 90% and decreases to 50% as a gradient thereby achieving intermediate concentrations including those at 70% or less. In effect, Appellant concedes that Lindner's concentration of 70% or less will substantially balance electrostatic repulsion with hydrophilic interaction as claimed. Viewed from this perspective, Appellant's argument militates for rather than against the Examiner's anticipation rejection. For the reasons given above and in the Answer, the Examiner has established a prima facie case of anticipation based on a rational determination that the amount of organic solvent in Lindner's Example B4 is sufficient to inherently substantially balance electrostatic repulsion with hydrophilic interaction as required in the independent claims. See In re Schreiber, 128 F.3d 1473, 1478 (Fed. Cir. 1997) (“[W]here the Patent Office has reason to believe that a functional limitation asserted to be critical for establishing novelty in the claimed subject matter may, in fact, be an inherent characteristic of the prior art, it possesses the authority to require the applicant to prove that the subject matter shown to be in the prior art does not possess the characteristic relied on” quoting In re Swinehart, 439 F.2d 210, 213 (CCPA 1971)). Appellant has failed to carry the requisite burden of providing this record with argument or evidence proving that Example B4 does not inherently substantially balance electrostatic repulsion with hydrophilic interaction. Appeal 2012-003530 Application 11/683,812 9 We sustain, therefore, the § 102 rejection of all appealed claims as anticipated by Lindner.1 The § 103 Rejections We sustain the § 103 rejection based on Lindner on the grounds that anticipation is the epitome of obviousness. See In re McDaniel, 293 F.3d 1379, 1385-86 (Fed. Cir. 2002). We also sustain the § 103 rejections based on Alpert alone or in combination with Hawley because Appellant does not present separate arguments against these rejections (App. Br. 12). Conclusion The decision of the Examiner is affirmed. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). AFFIRMED kmm 1 Notwithstanding the indefiniteness created by the independent claim phrase "an amount of organic solvent sufficient to substantially balance . . .", we are able to effectively assess the § 102 rejection based on the Examiner's establishment of prima facie anticipation by inherency and Appellant's failure to prove otherwise. Copy with citationCopy as parenthetical citation