Ex Parte McCrea et al

Patent Trial and Appeal BoardSep 17, 2018

13577529 (P.T.A.B. Sep. 17, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE FIRST NAMED INVENTOR 13/577,529 08/23/2012 20350 7590 09/19/2018 KILPATRICK TOWNSEND & STOCKTONLLP Mailstop: IP Docketing - 22 1100 Peachtree Street Suite 2800 Atlanta, GA 30309 UNITED ST A TES OF AMERICA Keith McCrea 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. 93808-000410US-880145 4945 EXAMINER FITZSIMMONS, ALLISON G ART UNIT PAPER NUMBER 1778 NOTIFICATION DATE DELIVERY MODE 09/19/2018 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): ipefiling@kilpatricktownsend.com KTSDocketing2@kilpatrick.foundationip.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte KEITH MCCREA and ROBERTS. WARD Appeal2017-011784 Application 13/577,529 Technology Center 1700 Before KAREN M. HASTINGS, JAMES C. HOUSEL, and JEFFREY R. SNAY, Administrative Patent Judges. HASTINGS, Administrative Patent Judge. DECISION ON APPEAL Appellants 1 seek our review under 35 U.S.C. Â§ 134(a) of the Examiner's decision rejecting claims 1-19 and 21-24 under 35 U.S.C. Â§ 103(a) as being unpatentable over Larm et al. (WO 2008/157 570 A2, published Dec. 24, 2008) ("Larm"). 2 1 Appellants identify the real party in interest as ExThera Medical Corporation (Appeal Br. 3). 2 The rejections set forth in the Final Office Action dated January 25, 2017 have been withdrawn by the Examiner (Ans. 2). TheÂ§ 103(a) rejection of claims 1-19 and 21-24 over Larm is set forth as a new ground of rejection in the Examiner's Answer (id.). Appeal 2017-011784 Application 13/577 ,529 We have jurisdiction over the appeal under 35 U.S.C. Â§ 6(b). 3 We AFFIRM. Independent claim 1 is illustrative of the subject matter on appeal (pathogen names have been italicized by Appellants and additional emphases added for limitations at issue on appeal): 1. A method for removal from mammalians' blood of a toxin from a pathogen, wherein said pathogen is a member selected from the group consisting of Bacillus anthracis, Pseudomonas aeruginosa, and Staphylococcus aureus, wherein the toxin from Bacillus anthracis is a member selected from the group of the anthrax lethal toxin, anthrax protective antigen, anthrax edema factor, anthrax lethal factor, anthrax polyglutamic acid capsule, anthralysin 0, anthralysin B; wherein the toxin from Pseudomonas aureginosa is Las A; and the toxin from Staphylococcus aureus is a member selected from the group consisting of S. aureus a-toxin, and S. aureus B- toxin, said method comprising: a) contacting a sample of blood with a carbohydrate immobilized on a solid substrate, said carbohydrate having binding affinity for said toxin, under conditions allowing the binding of said substrate to said pathogen or toxin in said sample of blood; and b) separating the sample from said substrate whereby said toxin is at least partially retained on said substrate and the removed sample has a reduced amount of said toxin, wherein the toxin from Bacillus anthracis is a member selected from the group consisting of the anthrax lethal toxin, anthrax protective antigen, anthrax edema factor, anthrax lethal factor, anthrax polyglutamic acid capsule, anthralysin 0, and anthralysin B; wherein the toxin from Pseudomonas aureginosa is Las A; and wherein the toxin from Staphylococcus aureus is a member selected from the group consisting of S. aureus a-toxin and S. aureus B-toxin. 3 We refer to the Specification, filed Aug. 7, 2012 ("Spec."); Appeal Brief, filed June 9, 2017 ("Appeal Br."); the Examiner's Answer, mailed Aug. 15, 2017 ("Ans."), and the Reply Brief filed Sept. 27, 2017 ("Reply Br."). 2 Appeal 2017-011784 Application 13/577 ,529 ANALYSIS We address claims separately from representative claim 1 only to the extent that they have been argued separately pursuant to 37 C.F.R. Â§ 4I.37(c)(l)(iv). Appellants' principal arguments on appeal are that the claimed invention is a new use based on unknown properties (i.e., the removal of a toxin expressed by a pathogen, as recited in claim 1 ), that Larm does not disclose or suggest such a use, and thus the Examiner's rejection is based upon impermissible hindsight (Appeal Br. 16-17, 20-25; Reply Br. 2--4). To support this argument, Appellants cite Examples 3 and 5 of their Specification to argue that pathogens (e.g., bacteria) and toxins are different, pathogens and toxins have different physical and chemical structures, and the mere disclosure of pathogen removal via a device does not provide a reasonable expectation of success for the device to also remove toxins (Appeal Br. 17-19, 26). The Examiner finds Larm discloses a method of removing harmful agents such as, for example, staphylococcus aureus, from mammalian blood and that any endogenous or exogenous molecule having a binding affinity for heparin may be removed using Larm's device (Ans. 3). The Examiner finds that although Larm does not explicitly recite the toxins recited in claim 1, it would have been obvious to treat mammalian blood in such a manner because Larm discloses the treatment of all mammalian blood and its treated substrate would remove any molecule having a binding affinity for heparin (i.e., not merely those expressly disclosed by Larm) (id. at 4). 3 Appeal 2017-011784 Application 13/577 ,529 Lann discloses a device having heparin immobilized on a substrate for extracorporeal removal of harmful agents from mammalian blood or blood components (Lann 1:2-6, 3:11-13). Lann discloses: The harmful agents of the present invention may for example be pro-inflammatory mediators, such as pro- inflammatory cells or pro-inflammatory proteins. However, the device of the present invention is not limited to the removal of pro-inflammatory cells and pro-inflammatory proteins. Any endogenous or exogenous molecule having a binding affinity for heparin may be removed using the inventive device. Also microorganisms comprising a molecule having a binding affinity for heparin may be removed using the inventive device. Microorganisms and molecules that may be removed from blood using a device according to the present invention comprise for example microorganisms selected from the group consisting of bacteria, viruses and parasites, along with proteins or other molecules encoded by or associated with such microorganisms. (id. at 9:23-10:4 (emphasis added)). Larm further discloses that a harmful agent may be "a microorganism causative of diseases or disorders in mammals, such as a virus, a bacterium or a parasite, as well as harmful agents symptomatic of diseases or disorders, such as a pro-inflammatory cytokine" but cautions: [ t ]he above mentioned examples of harmful agents should not be considered as limiting for the scope of the invention. As would be readily recognized by a person skilled in the art, all types of heparin binding harniful agents may be removed using a device or apparatus or method as disclosed by the present invention. (id. at 17: 12-15, 18: 1-5 (emphasis added)). Thus, as explained by the Examiner at pages 6-8 of the Examiner's Answer, even though Larm does not explicitly disclose its device would remove toxins, as recited in claim 1, Larm suggests such a use by disclosing 4 Appeal 2017-011784 Application 13/577 ,529 its device is useful to remove "[a]ny endogenous or exogenous molecule having a binding affinity for heparin" and by disclosing "all types of heparin binding harmful agents may be removed using a device or apparatus or method as disclosed by the present invention" (id. at 9:26-28, 18:2-5). As a result, Appellants' claimed invention is not the discovery of a new use for an old structure based on unknown properties, as in In re Hack, 245 F.2d 246, 248 (CCPA 1957), but is directed to a new property (i.e., the removal of toxins via a substrate treated with heparin), as in In re May, 574 F.2d 1082, 1090 (CCPA 1978) and In re Tomlinson, 363 F.2d 928 (CCPA 1966). As explained by Appellants via their quotation of Perricone v. Medicis Pharmaceutical, 432 F.3d 1368, 1378 (Fed. Cir. 2005) (Appeal Br. 21-22), the issue is not whether a prior art device, if used in the claimed manner, would inherently perform a function but whether the prior art suggests a claimed use. As explained above, Larm suggests the use recited in claim 1 by disclosing its device is useful for treating mammalian blood and that the device can remove any agent that binds with heparin. Furthermore, the Examiner finds Larm' s heparin "is the same material as claimed" (Ans. 3). Appellants do not dispute this finding. Nor do Appellants cite any evidence or persuasive technical reasoning that Larm's device would not be able to remove toxins, as recited in claim 1. Appellants cite a Declaration under 37 C.F.R. Â§ 1.132 by Dr. Keith McCrea to demonstrate that Larm's substrate will not remove Bacillus anthracis (Appeal Br. 19). However, as explained by the Examiner at page 7 of the Examiner's Answer, theÂ§ 1.132 Declaration does not address whether Larm's device would not remove toxins, which is the invention recited in claim 1. Appellants themselves argue pathogens and toxins are distinct from 5 Appeal 2017-011784 Application 13/577 ,529 one another ( Appeal Br. 1 7-18, 26). Therefore, the Â§ 1.13 2 Declaration has little weight and relevance for this rejection. Appellants further assert "[a]s it was completely unexpected that the claimed methods would remove 'toxins' expressed by the pathogenic bacteria, a skilled person would have no expectation of success of using a substrate to remove 'toxins' expressed by pathogenic bacteria" (Appeal Br. 19). This, however, is mere attorney argument that, in of itself, is not sufficient to demonstrate the criticality of a claim recitation (see In re Pearson, 494 F.2d 1399, 1405 (CCPA 1974) ("Attorney's argument in a brief cannot take the place of evidence."); see also In re Geisler, 116 F.3d 1465, 1470 (Fed. Cir. 1997) (attorney argument is not the kind of factual evidence that is required to rebut a prima facie case of obviousness)). In addition, Appellants contend Larm's disclosure of substances that can bind with heparin is broad and directed to a genus while the claimed invention is directed to a species not disclosed by Larm (Reply Br. 4--5). Appellants indicate that Larm's genus would encompass "hundreds, thousands or more 'proteins and other molecules"' and the size of such a genus would be so enormous that the claimed species would not have been obvious (id. at 4). These arguments are also unpersuasive. As discussed above, Appellants' invention appears to be directed to the discovery of a property (i.e., the removal of toxins) not disclosed by the prior art, which by itself does not defeat a prima facie case of obviousness (see In re Dillon, 919 F.2d 688, 692---693 (Fed. Cir. 1990)). Here, Larm does not merely disclose the genus asserted by Appellants but provides direction for its use by stating its device may be used to remove any agent that would bind with heparin. In addition, Appellants have not definitely established the size of Larm's genus 6 Appeal 2017-011784 Application 13/577 ,529 but vaguely characterize its quantity as "hundreds, thousands or more" (Reply Br. 4). Moreover, as discussed above, Appellants have not relied upon any evidence of unexpected results, nor provided any evidence that Larm's device would not function in the claimed manner. In view of the above, Appellants' arguments do not identify a reversible error in the Examiner's rejection of claim 1. Appellants do not argue claims 2-19 and 21-24 separately from claim 1 (Appeal Br. 16-26; Reply Br. 2-5). For the reasons discussed above and those set forth in the Examiner's Answer, we sustain the Examiner'sÂ§ 103(a) rejection of claims 1-19 and 21-24 over Larm. DECISION The Examiner's rejection of claims 1-19 and 21-24 is affirmed. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. Â§ 1.136(a). AFFIRMED 7