Paterson, Blake et al.Download PDFPatent Trials and Appeals BoardDec 9, 201915235313 - (D) (P.T.A.B. Dec. 9, 2019) 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. 15/235,313 08/12/2016 Blake Paterson ALB-034C3/107522-5034 5355 23517 7590 12/09/2019 MORGAN, LEWIS & BOCKIUS LLP (BO) 1111 PENNSYLVANIA AVENUE, N.W. WASHINGTON, DC 20004 EXAMINER REYNOLDS, FRED H ART UNIT PAPER NUMBER 1654 NOTIFICATION DATE DELIVERY MODE 12/09/2019 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): kcatalano@morganlewis.com patents@morganlewis.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte BLAKE PATERSON, PETER WARD, and ALESSIO FASANO ____________ Appeal 2019-003240 Application 15/235,313 Technology Center 1600 ____________ Before DONALD E. ADAMS, TIMOTHY G. MAJORS, and MICHAEL A. VALEK, Administrative Patent Judges. VALEK, Administrative Patent Judge. DECISION ON APPEAL Appellant1 submits this appeal under 35 U.S.C. § 134(a) involving claims to a method for treating Acute Respiratory Distress Syndrome (ARDS) or Acute Lung Injury (ALI). We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM IN PART. 1 We use the word “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42. Appellant identifies Alba Therapeutics Corporation and University of Maryland, Baltimore as the real parties in interest. Appeal Br. 3. Appeal 2019-003240 Application 15/235,313 2 STATEMENT OF THE CASE The Specification teaches that “[t]he pulmonary vascular endothelium lines the intravascular space and presents a selective barrier that actively regulates paracellular movement of circulating fluid, macromolecules, and cells, into extravascular tissues and compartments.” Spec. ¶ 3. According to the Specification, “[l]oss of this endothelial barrier integrity is the central defect found in ALI and ARDS.” Id. The Specification describes “methods for the treatment of an excessive or undesirable permeability of lung tissue containing tight junctions” involving administration of a “tight junction antagonist.” Id. ¶ 6. Claims 1, 2, 5–11, and 23 are on appeal and can be found in the Claims Appendix of the Appeal Brief. Claim 1 is representative of the claims on appeal. It reads as follows: 1. A method for treating acute respiratory distress syndrome or acute lung injury comprising: administering to a subject in need thereof, a composition comprising a peptide tight junction antagonist, wherein the tight junction antagonist is a peptide having the amino acid sequence GGVLVQPG (SEQ ID NO: 15). App. Br. 24. Appellant seeks review of the following rejections: I. Claims 1, 2, 5–11, and 23 under 35 U.S.C. § 103 as obvious over Fasano1,2 Fasano2,3 Dudek,4 and Rocco5; 2 US 6,670,448, issued Dec. 30, 2003 (“Fasano1”). 3 US 5,864,014, issued Jan. 26, 1999 (“Fasano2”). 4 Steven M. Dudek et al., Cytoskeletal Regulation of Pulmonary Vascular Permeability, J. Appl. Physiol., Vol. 91, 1487–1500 (2001) (“Dudek”). 5 Patricia R. M. Rocco et al., Effect of Corticosteroid on Lung Parenchyma Appeal 2019-003240 Application 15/235,313 3 and II. Claims 1, 5, and 23 for obviousness-type double patenting (“ODP”) over claims 1 and 7 of US 8,785,374 (the “’374 patent”) in view of Fasano1. App. Br. 7, 19. Analysis I. Obviousness Rejection The issue for this rejection is whether the preponderance of the evidence supports Examiner’s finding that Appellant’s claims are obvious over the cited prior art references. Examiner finds Fasano1 describes the peptide antagonist of SEQ ID NO: 15 and teaches that it inhibits the “ability of ZOT and zonulin (the mammalian proteins that physiologically modulate tight receptors . . .) to open mammalian tight junctions.” Final 3. Examiner notes that Fasano1 “does not specify use in the lungs, nor does it describe dosing regimens or ailments,” but determines it would be obvious to use SEQ ID NO: 15 as claimed because: (1) Fasano2 “shows that the ZOT receptor . . . is active in lung endothelium;” and (2) Dudek “shows the importance of junction integrity in the context of” ARDS and ALI. Id. at 4. Appellant contends, inter alia, that “there is no prior art teaching or suggestion of record that the endogenous factor ‘zonulin’ (which Fasano1 describes as being competitively inhibited by the recited peptide[]) plays any role in Acute Respiratory Distress Syndrome (ARDS) or Acute Lung Injury (ALI).” Appeal Br. 9–10. In particular, Appellant points out that Dudek, as Remodeling at an Early Phase of Acute Lung Injury, Am. J. Respir. Crit. Care Med., Vol. 168, 677–684 (2003) (“Rocco”). Appeal 2019-003240 Application 15/235,313 4 well as other references, provide “extremely detailed reviews of the state of knowledge of the biology and regulation of tight junctions in lung disease,” identifying a myriad of factors suspected of involvement in such regulation, but do not mention zonulin. Id. at 11–15. Thus, urges Appellant, Examiner’s determination that the claimed peptide would have been an obvious candidate for treating ARDS or ALI is not supported by the preponderance of the evidence. Id. We are persuaded by Appellant’s argument. Fasano1 teaches that the claimed peptide can be used to treat gastrointestinal inflammation and to inhibit breakdown of the blood brain barrier by binding to ZOT/zonulin receptors in the intestine and brain to modulate tight junction openings. See Fasano1 6:36–39, 7:35–40. Examiner relies on Fasano2 as evidence that one of skill would have understood that there are also ZOT receptors in lung endothelium. Final Act. 4. Even so, the presence of the receptor alone would not have provided one of ordinary skill with a reasonable expectation that the claimed peptide could also be used to treat ARDS or ALI. What is missing from the record before us is evidence that one of ordinary skill in the art would have understood that zonulin plays a role in the pathology of ARDS or ALI. Dudek does not overcome this evidentiary gap. At most, Dudek teaches that tight junctions are one of myriad structures related to lung permeability. Nothing in Dudek suggests antagonizing zonulin as a mechanism for modulating lung permeability to treat ARDS or ALI. Indeed, Dudek does not mention zonulin at all. Dudek instead identifies numerous other mediators involved in the “molecular events that regulate permeability” while noting that the “goal of modulating the [endothelial cell] Appeal 2019-003240 Application 15/235,313 5 barrier in a clinically advantageous way remains elusive . . . as evidenced by the failure of various clinical trials attempting to reduce the effects of individual cytokines or other mediators during . . . acute respiratory distress syndrome.” Dudek, 1495. Thus, Dudek supports Appellant’s argument that the art is not merely “complex,” as Examiner found, but highly unpredictable. See Appeal Br. 15 (quoting Advisory 3). As such, and absent any evidence connecting zonulin to the pathology of ARDS or ALI, the record does not support Examiner’s determination that one of ordinary skill would have a reasonable expectation of success in using a zonulin antagonist to treat ARDS or ALI. For this reason, we reverse the obviousness rejection. II. ODP Rejection The issue for this rejection is whether the preponderance of the evidence supports Examiner’s ODP rejection of claims 1, 5, and 23 over claims 1 and 7 claims of the reference ’374 patent in view of Fasano1. Claim 1 of the ’374 patent teaches the administration of a “peptide tight junction antagonist having three to five amino acids” to treat “excessive or undesirable permeability of tissue containing tight junctions.” ’374 patent, 49:16–21. Claim 7 depends from claim 1 and further specifies that “the subject has acute lung injury.” Id. at 50:17–18. Examiner finds it would have been obvious to use SEQ ID NO: 15, i.e., the peptide tight junction antagonist taught in Fasano1, in the method of claim 7 of the ’374 patent. See Final 7; Ans. 10. Thus, Examiner determines present claims 1, 5, and 23 are obvious over claims 1 and 7 of the ’374 patent in view of Fasano1. Id. Appellant does not dispute Examiner’s determination that present claims 1, 5, and 23 are obvious over claims 1 and 7 of the ’374 patent in view of Fasano1. See Appeal Br. 19–21. Instead, Appellant urges that Appeal 2019-003240 Application 15/235,313 6 Examiner should have applied the two-way test for ODP because the present application claims priority to applications filed before the ’374 patent. Id. at 19. According to Appellant, “the peptide tight junction antagonists recited in the claims of the ‘374 Patent were considered novel and non-obvious by the Office over Fasano1 (which discloses the peptide recited by the instant claims)” during prosecution of that patent. Id. at 20. Thus, argues Appellant, “when properly viewed in accordance with the two-way test for distinctiveness, the present claims are patentability distinct from the claims of the ‘374 Patent.” Id. at 21. We are not persuaded by Appellant’s argument that the two-way test for ODP should have been applied here. “A two-way test is to be applied only when . . . the Office is solely responsible for any delays.” MPEP § 804 II(B)(2)(c) (citing In re Berg, 140 F.3d 1428, 1435 (Fed. Cir. 1998)) (emphasis added). Here, however, the record does not demonstrate that the Office was solely responsible for the delay resulting in the later-filed patent application being issued first. Appellant’s present application is the third in a series of three continuations dating back to a PCT application filed June 27, 2008. Appellant filed a 371 application on December 29, 2009.6 A notice of missing requirements for that filing was mailed on September 23, 2010. On April 25, 2011, Appellant petitioned for a five month extension for its response to that notice, further delaying the start of examination. Once the application was ready for examination, Appellant pursued claims substantially similar to those in the present application that were finally rejected on September 28, 2012. Rather than appeal the rejection at that 6 All of the dates here refer to filings made by Appellant during prosecution of Application 12/667,192. Appeal 2019-003240 Application 15/235,313 7 time, Appellant decided to abandon the application and restart prosecution in a continuation filed on March 28, 2013. See In re Goodman, 11 F.3d 1045, 1053 (Fed. Cir. 1993) (holding that appellant’s choice “to forego an immediate appeal” and “file a continuation” demonstrated that “PTO actions did not dictate the rate of prosecution” and therefore no two-way analysis was required). All of these actions by Appellant occurred prior to the issuance of the ’374 patent. Based on this record, it cannot be said that it was “through no fault of the applicant” that the claims of the later-filed ’374 patent issued first. See MPEP § 804 II(B)(2)(c); In re Emert, 124 F.3d 1458, 1461 (Fed. Cir. 1997) (applying one-way test where the applicant “had significant control over the rate of prosecution” as evidenced by waiting six months to file a continuation and seeking numerous time extensions). Thus, only a one-way determination was required for the ODP rejection. Appellant does not challenge Examiner’s one-way determination, i.e., that claims 1, 5, and 23 are obvious over claims 1 and 7 of the ’374 patent in view of Fasano1. Accordingly, we affirm. CONCLUSION The rejection of claims 1, 2, 5–11, and 23 under 35 U.S.C. § 103 as obvious over Fasano1, Fasano2, Dudek, and Rocco is reversed. The ODP rejection of claims 1, 5, and 23 is affirmed. DECISION SUMMARY Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1, 2, 5–11, 23 103 Fasano1, Fasano2, Dudek, Rocco 1, 2, 5–11, 23 1, 5, 23 Obviousness-type 1, 5, 23 Appeal 2019-003240 Application 15/235,313 8 Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed Double Patenting Overall Outcome 1, 5, 23 2, 6–11 AFFIRMED IN PART Copy with citationCopy as parenthetical citation