Ex Parte Zikria et al

Patent Trial and Appeal BoardJan 28, 2014

11280104 (P.T.A.B. Jan. 28, 2014)

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. 11/280,104 11/17/2005 Bashir A. Zikria 7247 43399 7590 01/29/2014 EVELYN M. SOMMER 570 LEXINGTON AVENUE , 19TH FLOOR NEW YORK, NY 10022 EXAMINER FRONDA, CHRISTIAN L ART UNIT PAPER NUMBER 1652 MAIL DATE DELIVERY MODE 01/29/2014 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 BASHIR A. ZIKRIA and J. DEAN ZIKRIA __________ Appeal 2011-010656 Application 11/280,104 Technology Center 1600 __________ Before TONI R. SCHEINER, DEMETRA J. MILLS, and ULRIKE W. JENKS, Administrative Patent Judges. SCHEINER, Administrative Patent Judge. DECISION ON APPEAL This is an appeal1 under 35 U.S.C. § 134 from the final rejection of claims directed to a composition comprising activated protein C. The claims have been rejected as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. 1 Appellants identify Bashir A. Zikria and J. Dean Zikria as the Real Party- In-Interest (App. Br. 1). Appeal 2011-010656 Application 11/280,104 2 STATEMENT OF THE CASE Claims 1-9 are pending, but claims 1-4 have been withdrawn from consideration (App. Br. 3). Claims 5-9 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Lawrence,2 Bang,3 and Zikria 654.4, 5 Claim 5, reproduced below, is representative of the subject matter on appeal: 5. A composition comprising a member selected from the group consisting of hydroxyethyl starch, dextran, glycogen and mixtures thereof, and activated protein C, wherein said member is present in an amount of 5- 15% of the composition. DISCUSSION Lawrence discloses “a composition for the treatment or prophylaxis of Gram-negative bacteremia and septic shock compris[ing], in a single dosage form, a bactericidal effective amount of human polyclonal immunoglobulins . . . against antigens of Gram-negative bacteria and a blood clot-dissolving effective amount of activated protein C” (Lawrence, col. 3, ll. 22-28). In addition, Lawrence teaches that “[a]ctivated protein C can be formulated into an injectable preparation by mixing the sample with a suitable vehicle 2 US 5,093,117, issued March 3, 1992 to Joyce E. Lawrence et al. 3 US 4,775,624, issued October 4, 1988 to Nils U. Bang et al. 4 US 6,207,654 B1, filed April 22, 1997, and issued March 27, 2001 to Bashir Zikria and Jemal D. Zikria (“Zikria 654”). 5 Claims 5-9 were rejected on this ground in the Final Rejection mailed March 30, 2010, but independent claim 9 was not included in the rejection in the Examiner’s Answer. However, there is no indication on the record that the rejection has been withdrawn with respect to claim 9, and Appellants refer to the rejection of claims 5-9 in their Appeal Brief. In the absence of further clarification, we will treat the omission of claim 9 from the statement of the rejection as a typographical error. Appeal 2011-010656 Application 11/280,104 3 for injection such as a buffer (phosphates, sodium chloride, etc.), an isotonic agent, a filler (e.g. mannitol, dextran, etc.)” (id. at col. 7, ll. 30-34). Zikria 654 discloses, in relevant part, “treating human subjects to prevent leakage of macromolecules from capillary endothelial junctions as a consequence of . . . cancer biological therapy for cancer, infectious diseases, septic shock, and in viral infections implicated in human cancers” (Zikria 654, col. 1, ll. 11-37), by administering compositions comprising one or two polysaccharides and interleukin-2 or interferon. Hydroxyethyl starch, dextran, and glycogen are disclosed as polysaccharides suitable for the compositions (id. at col. 2, ll. 35-37, col. 3, ll. 3-4), and “[t]he amount of the polysaccharide macromolecules in the compositions . . . essentially range[s] between 3-50% but 6% is the preferred concentration” (id. at col. 6, ll. 41- 44). The Examiner acknowledges that Lawrence does not disclose “hydroxyethyl starch or dextran . . . present in the composition in an amount of 5-15%” (Ans. 5). However, the Examiner concludes that it would have been obvious for one of ordinary skill in the art to modify Lawrence’s composition “by adding hydroxyethyl starch, dextran, or hydroxyethyl starch and dextran in an amount of 6%of the composition” (id. at 6) “in order to attain the advantage of having a single composition for: (1) preventing leakage of macromolecules from capillary endothelial junctions as a consequence of . . . cancer biological therapy for cancer, infectious diseases, septic shock, and in viral infections; and (2) treating or prophylaxis of Gram-negative bacteremia and septic shock” (id. at 6-7). Appellants argue that “U.S. Patent No. 6,207,654 . . . relied on by the Examiner . . . for its teaching of the amounts of polysaccharide present in the Appeal 2011-010656 Application 11/280,104 4 compositions” (App. Br. 4) “is not available to the Examiner as prior art” (id.). According to Appellants, they filed two applications on April 22, 1997: Serial No. 08/837,840, the parent of the present continuation-in-part application, which issued as US 7,041,655,6 and Serial No. 08/837,841, which issued as US 6,207,654 (id. at 3-4). Appellants contend that the parent application, US 7,041,655, disclosed some components of present composition claim 5, specifically, hydroxyethyl starch and/or dextran in amounts ranging from 3-50%, preferably 6-12%, of the composition. Appellants argue that the common subject matter “is entitled to . . . the effective filing date of the ‘655 patent” (id. at 4, 5), and Zikria 654 is not available as prior art because its effective filing date is the same as the parent application’s and because the subject matter relied on by the Examiner is “not the invention of another but that of the inventors herein” (id. at 7-8). Appellants contend that Zikria 654 “is cited in connection with a critical limitation and, without it, the rejection cannot be maintained” (id. at 9-10). Appellants’ argument is not persuasive. We agree with the Examiner that “the filing date of the instant application, which is November 17, 2005, . . . [is the effective filing date] for prior art determinations for the claimed composition comprising a member selected from the group consisting of hydroxyethyl starch, dextran, glycogen and mixtures thereof and activated protein C” (Ans. 4, 12 (emphasis added)). 6 US 7,041,655 B1, filed April 22, 1997, and issued May 9, 2006 to Bashir Zikria and Jemal D. Zikria. Appeal 2011-010656 Application 11/280,104 5 To be entitled to the filing date of a previously filed application, appellant's application on appeal would have to satisfy the requirements of 35 U.S.C. § 120, among which is the requirement that the subject matter now claimed be disclosed in the manner prescribed by the first paragraph of section 112 in the prior application. Since, to conform to section 112, claimed subject matter must be described in the specification relied upon, subject matter which is first disclosed in a continuation- in-part application is not entitled to the filing date of the parent application. Application of Van Langenhoven, 458 F.2d 132, 136 (CCPA 1972). It is undisputed on this record that US 7,041,655, the parent application of the present continuation-in-part application, does not disclose activated protein C, and that Appellants’ first disclosure of a composition comprising activated protein C appears in the present application. Claim 5 is directed to a composition which includes activated protein C; therefore the claim is not entitled to the benefit of the filing date of US 7,041,655. Rather, the effective filing date of claim 5 is November 17, 2005 - the filing date of the present application. Zikria 654 has a publication date of March 27, 2001, which is more than one year prior to the filing date of the present application. Therefore, Zikria 654 is available as prior art under section 102(b) in a section 103(a) rejection of claim 5. That being the case, Appellants’ disclosure of an element of the presently claimed composition in the parent application is irrelevant. See Van Langenhoven, 458 at 137 (“[T]he fact that some of the elements of the breech claims have the support of the parent and foreign applications does not change the result. As to given claimed subject matter, only one effective date is applicable.”); see also id. (“It is of no avail to appellant that the Societe patent is his own”). Appeal 2011-010656 Application 11/280,104 6 Appellants further contend that: Zikria recites that the macromolecules can be present in an amount of 3-50% and preferably between 6 and 12%. The artisan would not consider adding to the Lawrence composition 6% of a filler. Most important, Lawrence does not suggest in any way that the disclosed composition can be used to prevent capillary leakage which is the purpose of the herein claimed invention, while Lawrence's compositions are for treating sepsis or septic shock[.] (App. Br. 9.) We are not persuaded. Lawrence’s activated protein C-containing composition and Zikria 654’s polysaccharide containing composition are both used to treat or prevent septic shock (see Lawrence, col. 3, ll. 22-28; Zikria 654, col. 1, ll. 11-37). We agree with the Examiner that it would have been obvious for one of ordinary skill in the art at the time of the invention to combine Lawrence’s composition and Zikria 654’s composition to form a single composition for treating or preventing Gram-negative bacteremia and septic shock, and for preventing leakage of macromolecules from capillary endothelial junctions resulting from septic shock (Ans. 6-7). The law does not require that the teachings of the reference be combined for the reason or advantage contemplated by the inventor, as long as some suggestion to combine the elements is provided by the prior art as a whole. In re Beattie, 974 F.2d 1309, 1312 (Fed. Cir. 1992); In re Kronig, 539 F.2d 1300, 1304 (CCPA 1976). Finally, Appellants contend that “the artisan would not consider eliminating the immunoglobin as that is the active bactericidal agent in Lawrence composition” (App. Br. 9). Appeal 2011-010656 Application 11/280,104 7 This argument is not persuasive. Claim 5 uses the open transitional term “comprising,” and does not preclude the presence of immunoglobulin in the claimed composition. SUMMARY The rejection of claim 5 under 35 U.S.C. § 103(a) as unpatentable over Lawrence, Bang, and Zikria is affirmed. The rejection of claims 6-9 is also affirmed as they were not separately argued. 37 C.F.R. § 41.37(c)(1). TIME PERIOD FOR RESPONSE 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 lp