Warren L. DingesDownload PDFPatent Trials and Appeals BoardMay 12, 202013800495 - (D) (P.T.A.B. May. 12, 2020) Copy Citation 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. 13/800,495 03/13/2013 Warren L. Dinges CYTO-001/01US 316241-2003 7869 58249 7590 05/12/2020 COOLEY LLP ATTN: IP Docketing Department 1299 Pennsylvania Avenue, NW Suite 700 Washington, DC 20004 EXAMINER BELEI, CARMENCITA ART UNIT PAPER NUMBER 1641 NOTIFICATION DATE DELIVERY MODE 05/12/2020 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): zIPPatentDocketingMailboxUS@cooley.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte WARREN L. DINGES Appeal 2018-0084641 Application 13/800,495 Technology Center 1600 Before ELIZABETH A. LAVIER, RACHEL H. TOWNSEND, and CYNTHIA M. HARDMAN, Administrative Patent Judges. HARDMAN, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134(a) involving claims related to a method of isolating a target from a sample, comprising forming a mixture comprising the sample, an antibody-linked immune-sedimentation agent, and red blood cells. The Examiner rejected the claims as anticipated under 35 U.S.C. § 102(b), and as obvious under 35 U.S.C. § 103(a). We have jurisdiction under 35 U.S.C. § 6(b). We affirm. 1 We use the word Appellant to refer to “applicant” as defined in 37 C.F.R. § 1.42. Appellant identifies the real party in interest as CytoSed Inc. Br. 3. Appeal 2018-008464 Application 13/800,495 2 CLAIMED SUBJECT MATTER The claims are directed to a method of isolating a target from a sample using an antibody-linked immuno-sedimentation agent (“ALISA”). Claims 1–3, 6–10, 12–15, 19, 21–29, 32, 34–39 and 66 are on appeal. See Final Act. 2. Claim 1, reproduced below, is illustrative of the claimed subject matter: 1. A method of isolating a target from a sample, the method comprising: a) forming a mixture comprising the sample, an antibody-linked immuno-sedimentation agent and red blood cells, wherein the sample comprises a target and an unwanted component, wherein the unwanted component comprises an antigen, and wherein the antibody-linked immuno- sedimentation agent comprises 1) at least one sedimentation agent that is capable of inducing red blood cell rouleaux formation and 2) at least one antibody linked to the at least one sedimentation agent by a non-antigen binding region of the antibody, wherein the antibody binds to the antigen; b) incubating the mixture under conditions sufficient to form a rouleaux and allow the antibody to bind to the antigen present in the mixture, thus forming a complex comprising the rouleaux, the antibody-linked immuno-sedimentation agent, and the unwanted component; c) separating the complex from the mixture; and d) recovering the target from the mixture following step (c), thereby isolating the target from the sample. Appeal 2018-008464 Application 13/800,495 3 REFERENCES The references relied upon by the Examiner are: Name Reference Date Van Vlasselaer US 5,840,502 Nov. 24, 1998 Kass EP 0696933 B1 July 17, 2002 Collins WO 2002/083262 A1 Oct. 24, 2002 Frank WO 2006/094810 A2 Sept. 14, 2006 REJECTIONS Claims 1–3, 6–10, 12–15, 22–29, 32, 34–35, 37–39, and 66 stand rejected under 35 U.S.C. § 102(b) as anticipated by Collins. Final Act. 10. Claims 1–3, 6–10, 12–15, 19, 21–29, 32, 34–39, and 66 stand rejected under 35 U.S.C. § 103(a) as obvious over Collins, Van Vlasselaer, Frank, and Kass.2 Final Act. 14. OPINION Appellant argues the claims together. See generally Br.3 We treat claim 1 as representative of the claims on appeal. Because Appellant did not separately argue the dependent claims, they stand or fall with claim 1. 37 C.F.R. § 41.37(c)(1)(iv). 2 Although the Examiner listed claims 5 and 30 as subject to the obviousness rejection (see Final Act. 14, Ans. 6), this appears to be an error, because claims 5 and 30 are not on appeal. See Final Act. 2; Br. 1. 3 More specifically, Appellant refers to “[i]ndependent claim 1” and “[i]ndependent claim 9,” and addresses them together. See Br. 5. Because claim 9 is not independent, we presume Appellant meant to refer to claim 39, which is the only other independent claim on appeal. See Br. 23. In any event, claim 1 is representative of the claimed subject matter. Appeal 2018-008464 Application 13/800,495 4 Anticipation The Examiner found that Collins teaches a method of isolating a target, e.g., certain cell types, comprising (a) forming a mixture of a blood sample, an immune sedimentation agent such as dextran, and an antibody (e.g., an anti-CD4 antibody) linked to a polysaccharide (e.g., dextran); (b) incubating the mixture under conditions sufficient to form a rouleaux and a complex comprising the rouleaux, the ALISA, and an unwanted component; (c) separating the complex from the mixture; and (d) recovering a target from the mixture following step (c). Final Act. 10–11. The Examiner found that Collins discloses that dextran can cause rouleaux formation, thus reading on the claim limitation directed to “at least one sedimentation agent that is capable of inducing red blood cell rouleaux formation,” which is recited in step (a)(1) of both independent claims 1 and 39. Id. We adopt the Examiner’s findings of fact (see, e.g., Final Act. 10–13; Ans. 3–5, 7–10), and agree that Collins anticipates independent claims 1 and 39. We address Appellant’s arguments below. Appellant argues that Collins fails to disclose a method that includes claimed step (b), which recites in relevant part: “forming a complex comprising the rouleaux, the antibody-linked immune-sedimentation agent, and the unwanted component.” Br. 6; see also id. at 8. Specifically, Appellant argues that Collins describes using free dextran and free antibodies (id. at 8), and “never discloses linking a sedimentation agent to the antibody.” Id. at 9. Appellant argues that “[s]ince the methods described by Collins et al. do not involve the use of an ALISA, they necessarily cannot result in the formation of a complex comprising the Appeal 2018-008464 Application 13/800,495 5 rouleaux, the ALISA, and the unwanted component, as recited in step (b) of the instant claims.” Id. at 8. We are not persuaded by Appellant’s arguments because we disagree that Collins fails to teach methods using an ALISA. Collins teaches that the antibodies used in its method “can be bound to substrates such as . . . polysaccharides.” Collins 3. Collins also teaches that “[d]extran is a polysaccharide,” and that it “can cause stacking of erythrocytes (i.e., rouleau formation) and thereby facilitate the removal of erythroid cells from solution.” Id. at 4. Collins further teaches that “[i]n some embodiments, an antibody is covalently linked to a polysaccharide such as high molecular weight (e.g., >1,000,000 Mr) dextran sulfate.” Id. at 7–8. Collins also teaches that in one embodiment involving use of anti-glycophorin A antibodies and dextran, the antibodies can facilitate the removal of red blood cells from solution by “stabiliz[ing] dextran-mediated Rouleau formation.” Id. at 4. Thus, we find that together, these teachings of Collins adequately disclose binding an antibody to dextran, i.e., forming an ALISA, where the dextran is “capable of inducing red blood cell rouleaux formation,” as recited in claims 1 and 39. Appellant acknowledges Collins’ teaching that the antibodies can be bound to a substrate, but argues that “it is very clear from the specification that the substrates referred to are particulates to facilitate capture and removal of antibody-bound cells via traditional mean[s],” e.g., using the mass of the particles to contribute to agglutination and cell separation. Br. 6; see also id. at 7 (arguing that Collins “indicates that the antibodies facilitate the removal of targeted blood cells via agglutination,” which is “well known in the art to be a process distinct from red blood cell rouleaux formation”). Appeal 2018-008464 Application 13/800,495 6 Appellant argues that “[i]t is abundantly clear that the substrates contemplated by Collins et al. do not include sedimentation agents capable of inducing red blood cell rouleaux formation.” Id. at 6. Appellant further argues that “when Collins et al. discloses an antibody covalently linked to a polysaccharide such as high molecular weight (e.g., >1,000,000 Mr) dextran sulfate (page 8, lines 1–2), it is clear that this is to facilitate purification based on the mass of the high molecular weight dextran sulfate particles and not via rouleaux formation.” Id. at 9. We are not persuaded by Appellant’s arguments. Again, Collins specifically teaches that dextran can be used as an antibody substrate, and additionally teaches that dextran can form rouleaux, which is one mechanism that facilitates separation. Collins 4. Further, on this record, Appellant has not pointed to any evidence demonstrating that high molecular weight (e.g., >1,000,000 Mr) dextran sulfate would not form rouleaux. See, e.g., Final Act. 12 (“[W]ith regards to the implication that dextran sulfate of a high molecular weight is not capable of inducing red blood cell rouleaux formation, attorney statements which are not evidence must be supported by an appropriate affidavit or declaration.”); see also Johnston v. IVAC Corp., 885 F.2d 1574, 1581 (Fed. Cir. 1989) (explaining that attorney argument is “no substitute for evidence”). We also agree with the Examiner that neither the intrinsic nor extrinsic evidence supports Appellant’s suggestion that high molecular weight dextran sulfate would not form rouleaux. Specifically, the appealed claims simply recite “dextran,” and Appellant’s Specification “is devoid of any definition of the genus dextran[,] and further discloses the sedimentation agent as soluble, semi-soluble or insoluble [0040] thus not excluding for example any dextran sulfate.” Final Act. 12. Additionally, Appeal 2018-008464 Application 13/800,495 7 Kass specifically identifies high molecular weight dextran as an agent that aggregates red blood cells into rouleaux. See Kass ¶¶ 3, 4, 15. Appellant further argues that none of the examples in Collins uses an ALISA, and that “[i]n each case, the antibody is NOT linked to an immunosedimentation agent,” and dextran is included in free form. Br. 6, 8. We are not persuaded by these arguments, because “a reference is not limited to the disclosure of specific working examples.” In re Mills, 470 F.2d 649, 651 (CCPA 1972). “Patents [and publications] are part of the literature of the art and are relevant for all they contain.” In re Young, 927 F.2d 588, 591 (Fed. Cir. 1991). As discussed above, Collins expressly teaches linking dextran and antibodies. For the above reasons, we affirm the Examiner’s anticipation rejection. Obviousness The Examiner rejected the claims as obvious over the combination of Collins, Van Vlasselaer, Frank, and Kass. Final Act. 14. The Examiner relied upon the teachings of Collins as summarized above, and further noted that Collins does not disclose HES, the elected species of sedimentation agent.4 Id. The Examiner found that Kass teaches a variety of aggregators capable of forming rouleaux, including dextran and HES (also known as 4 The Examiner indicated that Appellant elected the species of hydroxyethylstarch (“HES”) as the sedimentation agent. Final Act. 2, 14, 15–16. As to the § 103 rejection, we limit our analysis to the patentability of the species addressed by the Examiner, and take no position regarding the patentability of the broader generic claims. See Ex parte Ohsaka, 2 USPQ2d 1460, 1461 (BPAI 1987). Appeal 2018-008464 Application 13/800,495 8 “hespan”). Id. The Examiner further found that it would have been obvious to a skilled artisan to have substituted dextran with HES in the method of Collins, because dextran and HES were art-recognized equivalents, as taught by Kass. Id. at 14–15. The Examiner further found that Frank and Van Vlasselaer teach methods for linking an antibody to polymers such as dextran. Id. at 15. We adopt the Examiner’s findings of fact (see, e.g., Final Act. 14–17; Ans. 5–7, 10–12), and agree that the combination of Collins, Van Vlasselaer, Frank, and Kass renders obvious independent claims 1 and 39. Indeed, as discussed above, Collins anticipates these claims, and “anticipation is the epitome of obviousness.” In re McDaniel, 293 F.3d 1379, 1385 (Fed. Cir. 2002). Appellant argues that Collins fails to disclose both an antibody-linked immune-sedimentation agent as claimed, and the step of “forming a complex comprising the rouleaux, the antibody-linked immune-sedimentation agent, and the unwanted component,” and that none of the additional cited references teaches these features. Br. 10–11. For the reasons discussed above, we disagree that Collins lacks the cited features. We are also not persuaded by Appellant’s arguments that none of Van Vlasselaer, Frank, or Kass discloses an ALISA or relates to methods of forming the claimed complex. The Examiner relied on Collins for disclosing these features, and as discussed above, we agree with the Examiner that these features are disclosed in Collins. Appellant cannot show nonobviousness by attacking references individually as failing to teach all of the claimed limitations where, as here, the rejection is based on a combination of references, whose Appeal 2018-008464 Application 13/800,495 9 teachings together render obvious the claimed invention. See In re Keller, 642 F.2d 413, 425 (CCPA 1981). Appellant further argues that one of skill in the art would not have been motivated to combine the teachings of Frank with the methods taught by Collins, because “Frank relates to therapeutic compounds and their use in treatment, whereas Collins et al. relates to cell separation methods involving agglutination.” Br. 10–11. We are not persuaded. While we agree with Appellant that Frank relates to therapeutic compounds, this does not detract from the relevance of Frank to the Examiner’s rejection. The Examiner relied on Frank for the limited purpose of demonstrating that methods of attaching dextran to antibodies were known in the art. Final Act. 15. On this record, there is no dispute that the methods persons of ordinary skill in the art would have used for attaching dextran to antibodies were the same whether the complex was used for therapy as in Frank, or for laboratory use as in Collins. Any remaining points of Appellant not specifically addressed above have been addressed by the Examiner in the Final Action and Answer, and we adopt the Examiner’s responses as our own. CONCLUSION We affirm the rejection of claims 1–3, 6–10, 12–15, 22–29, 32, 34– 35, 37–39, and 66 under 35 U.S.C. § 102(b) as anticipated by Collins. We affirm the rejection of claims 1–3, 6–10, 12–15, 19, 21–29, 32, 34–39, 66 under 35 U.S.C. § 103(a) as obvious over Collins, Van Vlasselaer, Frank, and Kass. Appeal 2018-008464 Application 13/800,495 10 DECISION SUMMARY Claims Rejected 35 U.S.C. § Reference(s) Affirmed Reversed 1–3, 6–10, 12–15, 22– 29, 32, 34– 35, 37–39, 66 102(b) Collins 1–3, 6–10, 12–15, 22– 29, 32, 34– 35, 37–39, 66 1–3, 5–10, 12–15, 19, 21–30, 32, 34–39, 66 103(a) Collins, Van Vlasselaer, Frank, Kass 1–3, 6–10, 12–15, 19, 21–29, 32, 34–39, 66 Overall Outcome: 1–3, 6–10, 12–15, 19, 21–29, 32, 34–39, 66 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). See 37 C.F.R. § 1.136(a)(1)(iv). AFFIRMED Copy with citationCopy as parenthetical citation