Ex Parte Goldenberg et al

Patent Trial and Appeal BoardSep 17, 2012

11296432 (P.T.A.B. Sep. 17, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte DAVID M. GOLDENBERG and HANS J. HANSEN ____________ Appeal 2011-009765 Application 11/296,432 Technology Center 1600 ____________ Before DONALD E. ADAMS, FRANCISCO C. PRATS, and STEPHEN WALSH, Administrative Patent Judges. ADAMS, Administrative Patent Judge. DECISION ON APPEAL This appeal under 35 U.S.C. § 134 involves claims 1, 3, 18, 29, 30, 39, 41, 54, 58, 61-70, 72, 74, and 84-87 (App. Br. 2). 1 We have jurisdiction under 35 U.S.C. § 6(b). 1 Pending claims 2, 4, 71, and 76-83 stand withdrawn from consideration (App. Br. 2; see also Advisory Action, mailed September 28, 2010). Appeal 2011-009765 Application 11/296,432 2 STATEMENT OF THE CASE 2 The claims are directed to a multispecific antibody or a combination of separate antibodies that react(s) with at least two different targets. Due to a restriction requirement and species election we limit the scope of our review to Appellants‟ elected invention and species, which are directed to a multispecific antibody that comprises a therapeutic agent and reacts with at least two different targets that are (A) a proinflammatory effector of the innate immune system and (B) a target specifically associated with an inflammatory or immune-dysregulatory disorder, wherein the disorder is a neuropathy. Ex parte Ohsaka, 2 USPQ2d 1460, 1461 (BPAI 1987). Claim 1 is representative and is reproduced in the Claims Appendix of Appellants‟ Brief. Claims 1, 3, 18, 29, 30, 39, 41, 54, 58, 61-70, 72, 74, and 84-87 stand rejected under the written description provision of 35 U.S.C. § 112, first paragraph. Claims 1, 3, 18, 29, 30, 39, 41, 54, 61, 62, 64, 66, 69, 70, 72, and 74 stand rejected under 35 U.S.C. § 102(a) and (e) as being anticipated by Schuurman 3 as evidenced by Svejgaard. 4 Claims 1, 3, 18, 29, 30, 39, 41, 54, 61, 62, 64, 66, 69, 70, 72, and 74 2 Examiner did not include the obviousness-type double patenting rejection over claims 11-13 of U.S. Patent No. 7,435,803 or the provisional obviousness-type double patenting rejection over claims 1-25 of copending Application No. 11/929,279 in the Answer (Cf. App. Br. 5-6). Accordingly, we consider these rejections withdrawn by Examiner. Paperless Accounting, Inc. v. Bay Area Rapid Transit Sys., 804 F.2d 659, 663 (Fed. Cir. 1986), cert. denied, 480 U.S. 933 (1987). 3 Schuurman et al., US 2004/0170626 A1, issued Sept. 2, 2004. 4 Arne Svejgaard, The immunogenetics of multiple sclerosis, 60 IMMUNOGENETICS 275-286 (2008). Appeal 2011-009765 Application 11/296,432 3 stand rejected under 35 U.S.C. § 102(a) and (e) as being anticipated by Teeling. 5 Claims 1, 3, 18, 29, 30, 39, 41, 54, 58, 61-70, 72, 74, and 8[4] 6 -87 stand provisionally rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1-25 of copending Application No. 11/929,221. We affirm the rejection under 35 U.S.C. § 102(a) and (e) as being anticipated by Schuurman as evidenced by Svejgaard. We reverse all other grounds of rejection. Written Description: ISSUE Does the preponderance of evidence on this record support Examiner‟s conclusion that Appellants‟ Specification fails to provide written descriptive support for the claimed invention? FACTUAL FINDINGS (FF) FF 1. Examiner finds that while Appellants‟ Specification “discloses examples of certain species within the recited genera of „targets,‟ „effectors,‟ [„]antigens‟ or „receptors[]‟ . . . the genera comprise[s] numerous additional species which are not structurally related to those disclosed, and therefore the examples are deemed not to be representative of the recited genera” 5 Teeling et al., US 2004/0208873 A1, issued Oct. 21, 2004. 6 Examiner included claim 83 in this rejection. Since claim 83 was withdrawn from consideration we have not included this claim in our deliberations (see App. Br. 2; see also Advisory Action, mailed September 28, 2010). Appeal 2011-009765 Application 11/296,432 4 (Ans. 4; see also id. at 9 (“there are no „common attributes or features‟ to the generically recited molecules”)). FF 2. Examiner finds “that not all „immune-dysregulatory disorders‟ are presently known or understood, and neither are all the possible molecules „associated‟ with such disorders. Therefore, theose [sic] members of the recited groups that may be envisioned by the skilled artisan do not place applicant in possession of the entire groups” (id. at 8). ANALYSIS Examiner finds that Appellants are “not in possession of the claimed multispecific antibody” because the genus of targets to which the claimed multispecific antibody can react is broadly defined and encompasses structurally unrelated species, all of which are not disclosed in Appellants‟ Specification (Ans. 3-4; FF 1-2). We are not persuaded. Appellants‟ claimed multispecific antibody recognizes two specific target sets (see e.g., Claim 1). Examiner recognizes that Appellants‟ Specification discloses representative examples within each of these defined target sets (FF 1). Examiner failed to establish an evidentiary basis on this record to support a conclusion that a person of ordinary skill in this art would not have known or recognized the targets that fall within the scope of Appellants‟ claimed invention. As Appellants explain, on this record, “[t]he fact that the common attribute or feature is a functional one should not negative appellant‟s ability to properly protect the full scope of his contribution to the art” (Reply Br. 2; Cf. FF 3). We agree. CONCLUSION OF LAW The preponderance of evidence on this record fails to support Examiner‟s conclusion that Appellants‟ Specification fails to provide written Appeal 2011-009765 Application 11/296,432 5 descriptive support for the claimed invention. The rejection of claims 1, 3, 18, 29, 30, 39, 41, 54, 58, 61-70, 72, 74, and 84-87 under the written description provision of 35 U.S.C. § 112, first paragraph is reversed. Anticipation: ISSUE Does the preponderance of evidence on this record support Examiner‟s finding that Schuurman and/or Teeling teach Appellants‟ claimed invention? FACTUAL FINDINGS (FF) FF 3. “Sc[huurman] teaches bispecific antibodies that bind to CD25 and IL-15” (Ans. 5; Schuurman 46: col. 2, ll. 20-22 and 44: col. 1, ll. 2-3). FF 4. IL-15 is a proinflammatory effector cytokine within the scope of Appellants‟ claimed invention (see Spec. 13: ¶ [0033]). FF 5. Schuurman teaches a method of treating or preventing a disorder involving cells expressing CD25, wherein the disorder is, inter alia, an immune, autoimmune or inflammatory disease, such as multiple sclerosis and inflammatory bowel disease the comprises administering an antibody that binds to human CD25 (Ans. 6; Schuurman: 46: col. 2, ll. 30-37 and 44: col. 1, ll. 2-3). FF 6. Examiner relies on Svejgaard, a post-filing date reference, to suggest that “CD25 is specifically associated with multiple sclerosis . . . an immune- dysregulatory disorder” (Ans. 5; Svejgaard 281: col. 2, ll. 37-39 (“the IL2- receptor (CD25) pathway seems to play a role in several autoimmune diseases, which may reflect the importance of regulatory T-cells”)). Appeal 2011-009765 Application 11/296,432 6 FF 7. Examiner finds that Schuurman teaches bispecific antibodies within the scope of Appellants‟ claimed invention that comprise a therapeutic agent (Ans. 6). FF 8. Examiner finds that the generic term “neuropathy” refers to a “pathology of neurons or of the nervous system, [that is] not necessarily limited to [the] peripheral nervous system. As such, multiple sclerosis, as a pathology of neurons and of the nervous system, is within the scope [of] the [generic term] . . . „neuropathy‟” (Ans. 10). FF 9. T[eeling] teaches bispecific antibodies that bind to IL-8 and CD64” (id. at 6). FF 10. IL-8 is a proinflammatory effector cytokine within the scope of Appellants‟ claimed invention (see Spec. 13: ¶ [0033]). FF 11. Examiner finds that “CD64 expression is associated with inflammation e.g. in Behcet‟s disease, and as such is inherently associated with immune-dysregulatory disorders” (Ans. 6). FF 12. Teeling teaches a method of inhibiting IL-8 induced proinflammatory effects, wherein the disorder is Behcet‟s disease, in a subject comprising administering an antibody that binds to human IL-8 (Teeling 40: col. 2, 4-43 and 37: claims 1 and 2). ANALYSIS The rejection over Schuurman as evidenced by Svejgaard: The claims were not separately argued and therefore stand or fall together. 37 C.F.R. § 41.37(c)(1)(vii). Claim 1 is representative. Schuurman teaches an antibody within the scope of Appellants‟ claim 1 (FF 3-5 and 7). Appellants contend that Schuurman fails to teach a target “specifically associated with an inflammatory or immune-dysregulatory Appeal 2011-009765 Application 11/296,432 7 disorder” (App. Br. 10). We are not persuaded (FF 5). Appellants contend that Svejgaard fails to teach that CD25 is associated with multiple sclerosis (App. Br. 10). We are not persuaded. Svejgaard teaches that “the IL2- receptor (CD25) pathway seems to play a role in several autoimmune diseases, which may reflect the importance of regulatory T-cells,” which is cumulative to the teaching of Schuurman (FF 5-6). We recognize Appellants‟ contention that “[p]eripheral neuropathy is not a feature of MS” (App. Br. 11). Nevertheless, the elected species at issue is a generic “neuropathy,” not “peripheral neuropathy,” as asserted by Appellants. Therefore, we are not persuaded by Appellants‟ contention for the reasons set forth by Examiner (Ans. 10; see also FF 8). The rejection over Teeling: Teeling teaches a bispecific antibody that binds IL-8 and CD64 (FF 9). Examiner failed to identify an evidentiary basis on this record to support a finding that “CD64 expression is associated with inflammation e.g. in Behcet‟s disease, and as such is inherently associated with immune- dysregulatory disorders” (FF 11). To the contrary, Teeling teaches that a method of inhibiting IL-8 induced proinflammatory effects, wherein the disorder is Behcet‟s disease, in a subject comprising administering an antibody that binds to human IL-8 (FF 12). IL-8 is a proinflammatory effector cytokine within the scope of Appellants‟ claimed invention (FF 10). Therefore, while Teeling‟s antibody may be bispecific and bind to both IL-8 and CD64, Examiner failed to establish that CD64 is a target specifically associated with an inflammatory or immune-dysregulatory disorder as required by Appellants‟ claimed invention (see generally App. Br. 14-15). Appeal 2011-009765 Application 11/296,432 8 CONCLUSION OF LAW The preponderance of evidence on this record support Examiner‟s finding that Schuurman teaches Appellants‟ claimed invention. The rejection of claim 1 under 35 U.S.C. § 102(a) and (e) as being anticipated by Schuurman as evidenced by Svejaard is affirmed. Claims 3, 18, 29, 30, 39, 41, 54, 61, 62, 64, 66, 69, 70, 72, and 74 are not separately argued and fall together with claim 1. 37 C.F.R. § 41.37(c)(1)(vii). The preponderance of evidence on this record fails to support Examiner‟s finding that Teeling teaches Appellants‟ claimed invention. The rejection of claims 1, 3, 18, 29, 30, 39, 41, 54, 61, 62, 64, 66, 69, 70, 72, and 74 under 35 U.S.C. § 102(a) and (e) as being anticipated by Teeling is reversed. Provisional Obviousness-type Double Patenting: ISSUE Does the preponderance of evidence on this record support Examiner‟s provisional rejection under the judicially created doctrine of obviousness-type double patenting? FACTUAL FINDINGS (FF) FF 13. Examiner finds that Appellants‟ “claim 1 is directed to essentially the same subject matter as currently pending claims 1 and 25 of USSN 11/929,221, the only difference being that . . . the claims of USSN 11/929,221 contain a recitation of target (A) which is “a proinflammatory effector of the innate immune system” (Ans. 7 and 11-12). Appeal 2011-009765 Application 11/296,432 9 ANALYSIS Examiner concludes that the scope of Appellants‟ claims overlaps the subject matter of claims 1-25 of copending Application No. 11/929,221 („221). We are not persuaded. As Appellants explain, due to restriction requirements in this application and the „221 application the subject matter of the two applications is distinct (Reply Br. 3 7 ). This is consistent with Examiner‟s finding in the „221 application (See Application No. 11/929, 221, paper mailed March 29, 2012, page 3 (“Application 11/296,432 is the immediate parent of the instant application [(„221)]. . . . However, due to restriction requirements, the invention appealed in the „432 application and the instant application are different inventions”)). CONCLUSION OF LAW The preponderance of evidence on this record fails to support Examiner‟s provisional rejection under the judicially created doctrine of obviousness-type double patenting. The provisional rejection of claims 1, 3, 18, 29, 30, 39, 41, 54, 58, 61-70, 72, 74, and 84-87 under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1-25 of copending Application No. 11/929,221 is reversed. 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-IN-PART 7 The reply Brief is not paginated. Accordingly, we refer to page numbers as if the Reply Brief was numbered consecutively beginning with the first page. Appeal 2011-009765 Application 11/296,432 10 cdc