Ex Parte CASTOR et al

Patent Trial and Appeal BoardFeb 6, 2019

14019671 (P.T.A.B. Feb. 6, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 14/019,671 09/06/2013 86738 7590 02/08/2019 MCCARTER & ENGLISH, LLP BOSTON 265 Franklin Street Boston, MA 02110 FIRST NAMED INVENTOR Trevor Percival CASTOR 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. 550539 ACJ-001 5219 EXAMINER SCHUBERG, LAURA J ART UNIT PAPER NUMBER 1657 NOTIFICATION DATE DELIVERY MODE 02/08/2019 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@mccarter.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte TREVOR PERCIVAL CASTOR and VASUDEYACHARYAJAYARAMA Appeal2017-004536 Application 14/019,671 1 Technology Center 1600 Before JEFFREY N. FRED MAN, ELIZABETH A. LA VIER, and TIMOTHY G. MAJORS, Administrative Patent Judges. LA VIER, Administrative Patent Judge. DECISION ON APPEAL Pursuant to 35 U.S.C. Â§ 134(a), Appellants seek review of the Examiner's rejection of claims 1-12. We have jurisdiction under 35 U.S.C. Â§ 6(b ). For the reasons set forth below, we AFFIRM. BACKGROUND The Specification describes compositions and methods for inactivating viral agents in blood based products such as red blood cell concentrate or whole blood. See Spec. 2:6-7, 2:18-20. Claim 1, the only independent claim on appeal, is illustrative: 1 Appellants identify the real party in interest as Aphios Corporation. Br. 3. Appeal2017-004536 Application 14/019,671 1. A method for inactivating a viral agent comprising the steps of placing an article potentially having a viral agent said article selected from the group consisting of whole blood and red blood concentrate in the presence of an admixture consisting of a light sensitive compound and a group of light producing compounds, wherein said light sensitive compound is selected from the group consisting of hypericin, pseudohypericin and hypocrellin, said group of light producing compounds is luciferase, luciferin and ATP, said light producing compounds and light sensitive compound in a concentration for a period of time sufficient for light producing reactions to produce light sufficient to react with said light sensitive compound and said viral agent to inactivate said viral agent. Br. 13 (Claims Appendix). REJECTION MAINTAINED ON APPEAL Claims 1-12 stand rejected under 35 U.S.C. Â§ 103 as unpatentable over Kraus2 and Park. 3 Ans. 2. DISCUSSION The Examiner's thorough findings and analysis are set forth on pages 4---6 of the Final Action and further explained at pages 2-9 of the Answer. In essence, the Examiner finds that Kraus provides a method of inactivating virus, using a composition that may contain hypericin, luciferin, luciferase, and ATP, in concentrations "fall[ing] into many of the claimed ranges." Final Action 4--5 (citing Kraus 5:1-2, 5:63---6:26, col. 23---col. 24). Kraus notes that prior art methods use photodynamic therapy for viral 2 Kraus et al., US 5,780,287, issued July 14, 1998. 3 Park et al., US 5,516,629, issued May 14, 1996. 2 Appeal2017-004536 Application 14/019,671 contaminants in blood banking (see id. at 5 (citing Kraus 2:16-25)), but the Examiner turns to Park as teaching a method of inactivating viral contaminants in blood and blood products using photosensitizer compositions combined with photosensitizing molecules (such as hypericin, luciferin, and luciferase) (id. ( citing Park 1 :20-31, 9:45---65) ). The Examiner finds that it would have been obvious for the ordinarily skilled artisan to use Kraus' method on blood products (such as red blood cells and whole blood) as taught in Park, motivated by Park's teaching that hypericin, luciferin, and luciferase can be used for photo sensitization, and Kraus' disclosure of prior art applications in blood banking. Id. at 5---6 (citing Kraus 2:16-25, 32:1-7). Further, the Examiner finds that "[ t ]he selection of specific concentrations clearly would have been a routine matter of optimization and experimentation," as the ordinarily skilled artisan would have recognized that "the concentrations of these components would have affected the properties of the article treated and the clearance of the viral contamination." Id. at 6. Appellants' arguments in support of claim 1 (see Br. 5-11) depend largely on limitations that are not recited in claim 1, or argue the references individually. For example, Appellants attempt to discredit Kraus' disclosure of photoactivation of hypericin by the luciferase-catalyzed luciferin reaction (see Kraus 24:9-19) using commercially available components (see id. 23:51-52) as achieving "a mere 90%" viral inactivation, compared to better results with white light (Br. 6 (discussing Kraus 24:13-15)). But as the Examiner points out, "[t]he claims do not require a specific level or 3 Appeal2017-004536 Application 14/019,671 percentage of viral inactivation." Ans. 4. 4 "[C]laims are not to be interpreted by adding limitations appearing only in the specification. Thus, although the specifications may well indicate that certain embodiments are preferred, particular embodiments appearing in a specification will not be read into the claims when the claim language is broader than such embodiments." Electro Med. Sys. S.A. v. Cooper Life Sci. Inc., 34 F.3d 1048, 1054 (Fed. Cir. 1994) (citations omitted). Likewise, Appellants' related suggestion that this 90% inactivation disclosure in Kraus teaches away from the claimed invention (see Br. 6) is not correct. "A statement that a particular combination is not a preferred embodiment does not teach away absent clear discouragement of that combination." Syntex (USA) LLC v. Apotex, Inc., 407 F.3d 1371, 1380 (Fed. Cir. 2005). Appellants also argue that Kraus' preferred embodiments require linking or tethering the molecular components, or an external light source. See Br. 6; see also id. at 10. Again, these disclosures do not amount to teachings away, and at any rate, claim 1 does not exclude such additional features, as the Examiner points out (see Ans. 3, 5). Appellants' parallel assertions regarding Park (see Br. 7) are similarly not persuasive (see Ans. 4--5). Appellants characterize Park as "only speculating as to the additive effect" of the combination ofhypericin, luciferin, and luciferase, over Park's use of coumarin, as "Park et al. only 'anticipate,' they do not know." Br. 7. This is not persuasive. As an initial matter, the expectation of success need only be reasonable in light of the scope of the prior art; it need not be 4 Nor do Appellants establish that the Specification necessitates interpreting "inactivating a viral agent" in a more limiting way. 4 Appeal2017-004536 Application 14/019,671 certain. See In re Langi, 759 F.2d 887, 897 (Fed. Cir. 1985) ("Only a reasonable expectation of success, not absolute predictability, is necessary for a conclusion of obviousness."). Further, this argument is not pertinent to the basis on which the Examiner relies on Park, i.e., "to demonstrate that combinations of photosensitizer compounds with photosensitizing molecules that adsorb in the visible light wavelength, such as hypericin, luciferin and luciferase are suggested as suitable for use with blood cells and whole blood." Ans. 5. Appellants also argue that the thrice-repeated phrase, "consisting of," in claim 1, "is used with respect to each and every element of the claim" and, as such, "[t]he claim language is not 'open"' to additional features. Br. 9. This is not correct. Claim 1 begins with open language, by introducing a method "comprising the steps of ... " (emphasis added). "'Comprising' is a term of art used in claim language which means that the named elements are essential, but other elements may be added and still form a construct within the scope of the claim." Genentech, Inc. v. Chiron Corp., 112 F.3d 495, 501 (Fed. Cir. 1997). In claim 1, two of the three "consisting of' phrases introduce closed lists of alternatives, i.e., Markush groups (see MPEP Â§ 2173.05(h)(I)). And the other use of"consisting of' at most closes the claim as to the components of the admixture. Especially in view of the broadest reasonable interpretation standard applied to claims during prosecution, see In re Morris, 127 F.3d 1048, 1054 (Fed. Cir. 1997), we conclude that these closed lists within an otherwise open claim do not change the overall open nature of claim 1. See generally In re Crish, 393 F.3d 1253, 1257 (Fed. Cir. 2004) ("Crish's principal argument here that the claims also contain the closed-ended transition term 'consists,' and that that 5 Appeal2017-004536 Application 14/019,671 term narrows the entire claim, is unpersuasive. The reasonable interpretation of the claims containing both of the terms 'comprising' and 'consists' is that the term 'consists' limits the 'said portion' language to the subsequently recited numbered nucleotides, but the earlier term 'comprising' means that the claim can include that portion plus other nucleotides."). Finally, Appellants argue secondary considerations in various guises, namely unexpected results (see Br. 7-8) and long-felt need in the art (see id. at 9). Both rely solely on attorney argument, not evidence, and are not persuasive for this reason alone. See In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992) (explaining that appellant bears the burden of establishing evidence to rebut a prima facie case of obviousness); Knorr v. Pearson, 671 F.2d 1368, 1373 (CCPA 1982) ("[A]rguments of counsel cannot take the place of evidence lacking in the record."). Furthermore, as to the allegedly "striking and unexpected" results (id. at 7), driven by the allegedly "critical" nature of the concentrations (id. at 8), we note that claim 1 does not recite any particular ranges ( or, in other words, as the Examiner points out, the Specification's examples are not commensurate in scope with the claimed invention (Ans. 6)) and do not require a specific level of viral inactivation (id.). Also, no explanation ( or evidence, as noted above) is offered as to how the results reported in the Specification are unexpected relative to the closest prior art. Regarding Appellants' perhaps-related description of their success in "achieving viral inactivation without external light" as "remarkable" (Br. 10), this too is unsupported attorney argument. 5 5 Furthermore, as discussed above, the claims do not exclude an external light source. 6 Appeal2017-004536 Application 14/019,671 As for long-felt need in the art, Appellants fail to demonstrate any nexus between the allegedly long-felt need and the particular improvements embodied in the claims. Appellants cannot rely on Park to establish a long- felt need (see Br. 9-10), because Park demonstrates "one potential solution" to the problem of viral inactivation of blood products (Ans. 7), thus satisfying that long-felt need. Appellants have not established a more specific long-felt need, or how the claimed invention provides a solution for it. Appellants' generalized assertion of a "continued need" for improvement in the art (Br. 11) is not sufficient. See In re Huai-Hung Kao, 639 F .3d 1057, 1068 (Fed. Cir. 2011) ("Where the offered secondary consideration actually results from something other than what is both claimed and novel in the claim, there is no nexus to the merits of the claimed invention."). Having considered Appellants' arguments in support of claim 1, we are not persuaded of any reversible error in the Examiner's rejection of claim 1. For the reasons described herein and those already of record, we sustain the Examiner's rejection of claim 1. Claims 2--4 are not argued separately, and fall with claim 1. See 37 C.F.R. Â§ 4I.37(c)(l)(iv). Appellants briefly address claims 5-12 as a group under a separate heading, but the arguments presented recapitulate those already discussed with respect to claim 1. See Br. 11. Furthermore, we agree with the Examiner's finding that "the specific concentrations recited in claims 5-12 are in fact quite close to those recited by references (see Kraus et al column 23---column 24) and therefore easily attainable by routine optimization and experimentation as result effective variables." Ans. 6. Accordingly, we sustain the Examiner's rejection of claims 5-12. 7 Appeal2017-004536 Application 14/019,671 CONCLUSION We sustain the Examiner's rejection of claims 1-12. 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)(l )(iv). AFFIRMED 8