Ex Parte Antoniades et alDownload PDFPatent Trial and Appeal BoardFeb 24, 201712688034 (P.T.A.B. Feb. 24, 2017) 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. 12/688,034 01/15/2010 Charalambos Antoniades EPROV-0026-D01 2745 23599 7590 02/28/2017 MILLEN, WHITE, ZELANO & BRANIGAN, P.C. 2200 CLARENDON BLVD. SUITE 1400 ARLINGTON, VA 22201 EXAMINER THOMAS, TIMOTHY P ART UNIT PAPER NUMBER 1628 NOTIFICATION DATE DELIVERY MODE 02/28/2017 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): docketing@mwzb.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte CHARALAMBOS ANTONIADES, CHEERAG SHIRODARIA, KEITH M. CHANNON, and RUDOLF MOSER.* 1 Appeal 2016-003411 Application 12/688,034 Technology Center 1600 Before MELANIE L. McCOLLUM, TAWEN CHANG, and JOHN E. SCHNEIDER, Administrative Patent Judges. SCHNEIDER, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134(a) involving claims to a method for treating cardiovascular disease which have been rejected as indefinite and as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. 1 Appellants identify the Real Party in Interest as Merck & Cie. Appeal Br. 1. Appeal 2016-003411 Application 12/688,034 STATEMENT OF THE CASE The present invention is directed to the use of folates to prevent and/or treat cardiovascular disease. Spec. 1. The folates modulate endothelial nitric oxide synthase. Id. Claims 24, 27, 35, 47, and 54 are on appeal. Claim 35 is the sole independent claim and reads as follows: 35. A method for improving NO-mediated endothelial- dependent vasomotor responses consisting of: administering to a subject with a cardiovascular disease an effective amount of a pharmaceutical composition consisting of a pharmaceutically active agent suitable for improving NO- mediated endothelial-dependent vasomotor responses and one or more pharmaceutically acceptable carriers, wherein the pharmaceutically active agent consists of one or more folates or a pharmaceutically acceptable salt or ester thereof, and wherein said effective amount of the pharmaceutical composition achieves improvement of the NO-mediated endothelial-dependent vasomotor responses. The claims stand rejected as follows: Claims 24, 27, 35, 47, and 54 have been rejected under 35 U.S.C. § 103(a) as unpatentable over van Etten.2 Claims 24, 27, 35, 47, and 54 have been rejected under 35 U.S.C. §112, second paragraph as indefinite. 2 van Etten et al., Impaired NO-dependent vasodilation in patients with Type II (non-insulin-dependent) diabetes mellitus is restored by acute administration of folate, 45 Diabetologia 1004—1010 (2002) (“van Etten”). 2 Appeal 2016-003411 Application 12/688,034 THE REJECTION UNDER 35 U.S.C. § 103(a) Issue The issue with respect to this rejection is whether the Examiner has established by a preponderance of the evidence that claim 353 would have been obvious over van Etten as defined by 35 U.S.C. § 103(a). The Examiner finds that van Etten teaches that administration of 5- methyltetrahydrofolate (“5-MTHF”) with serotonin or sodium nitroprusside improves NO-dependent vasodilation and reduces vascular oxidative stress in insulin-resistant rats. Final Act. 13. The Examiner concludes that it would have been obvious to one of ordinary skill in the art to administer an effective amount of 5 MTHF alone to patients with Type-II diabetes with a reasonable expectation of improving NO-dependent vasodilation impairment. Final Act. 16. Appellants contend that van Etten teaches improvement in NO- mediated vasodilation only when co-administered with serotonin. Appeal Br. 7—8. Appellants argue that this is different from the claimed method which calls for administration of only a folate. Appeal Br. 9 Appellants argue that van Etten teaches away from using 5-MTHF alone in that van Etten demonstrates that use of 5-MTHF alone produces no effect. Appeal Br. 8-11. 3 Claims 24, 27, 47, and 54 have not been argued separately and therefore fall with claim 35. 37 C.F.R. § 41.37(c)(l)(iv). 3 Appeal 2016-003411 Application 12/688,034 Findings of Fact We adopt as our own the Examiner’s findings and analysis. The following findings are included for emphasis and reference convenience. FF1. van Etten teaches that the administration of 5-MTHF increase vasodilation in patients with diabetes when compared to patients administered serotonin alone, van Etten 1007, Fig. 1. FF2. van Etten teaches that “5-MTHF administration restores impaired NO-mediated vasodilation in patients with Type II diabetes despite the presence of several diabetes-related risk factors such as hyperglycaemia, dyslipidaemia and hypertension.” van Etten 1008, col. 1. FF3. van Etten goes on to teach that they have shown a specific ameliorative effect of the active form of folic acid, 5- MTHF, on endothelial dysfunction as measured by endothelium-dependent NO-mediated vasodilation in patients with uncomplicated Type II diabetes. This could be of clinical importance since endothelial dysfunction is associated with increased cardiovascular risk. Our results provide a strong rationale for the initiation of studies that investigate whether in this patient group supplementation with folic acid, a safe, readily available, not expensive and well-tolerated drug, prevents future cardiovascular events. van Etten 1008, col. 2. Principles of Law “The test of obviousness vel non is statutory. It requires that one compare the claim’s ‘subject matter as a whole’ with the prior art ‘to which said subject matter pertains.’” In re Ochiai, 71 F.3d 1565, 1569 (Fed. Cir. 1995) (quoting 35 U.S.C. § 103). 4 Appeal 2016-003411 Application 12/688,034 A reference may be said to teach away when a person of ordinary skill, upon reading the reference, would be discouraged from following the path set out in the reference, or would be led in a direction divergent from the path that was taken by the applicant. The degree of teaching away will of course depend on the particular facts; in general, a reference will teach away if it suggests that the line of development flowing from the reference’s disclosure is unlikely to be productive of the result sought by the applicant. In re Gurley, 27 F.3d 551, 553 (Fed. Cir. 1994). Analysis Substantial evidence supports the Examiner’s position. Van Etten teaches the administration of 5-MTHF with serotonin increases vasodilation in diabetic patients versus serotonin alone. FF1. Van Etten teaches that those in the art should study the benefits of using 5-MTHF (not 5-MTHF with serotonin) to ameliorate endothelial dysfunction and prevent cardiovascular events. FF3. We agree with the Examiner that the teachings of van Etten would have motivated one skilled in the art to use a folate alone to improve NO-mediated vasodilation with a reasonable expectation of success. Final Act. 16—17. Appellants contend that van Etten teaches that 5-MTHF only increases vasodilation when used in combination with serotonin. Appeal Br. 7—8. We are unpersuaded. While the data presented in van Etten is limited to the use of 5-MTHF in combination with other compositions, van Etten suggests that the use of 5-MTHF alone can improve vasodilation and specifically urges work to confirm this finding. FF2 and 3. 5 Appeal 2016-003411 Application 12/688,034 Appellants argue that van Etten teaches away from using 5-MTHF alone in that the data shows that when it is administered alone, it does not cause a change in vasodilation. Appeal Br. 9—11. We remain unpersuaded. As noted above, van Etten contains a clear teaching encouraging work to confirm the effectiveness of folic acid alone. FF3. This is a far cry for a teaching that “the line of development flowing from the reference’s disclosure is unlikely to be productive of the result sought by the applicant.” In re Gurley, 27 F.3d 551, 553 (Fed. Cir. 1994). We conclude that substantial evidence supports the Examiner’s conclusion that claim 35 would have been obvious over van Etten under 35 U.S.C. § 103(a). THE REJECTION UNDER 35 U.S.C. § 112, SECOND PARAGRAPH Issue The issue with respect to this rejection is whether substantial evidence supports the Examiner’s conclusion that claim 354 is indefinite. The Examiner finds that the use of the term “consisting of’ renders the claim indefinite in that one skilled in the art would not know the metes and bounds of the claim. Final Act. 24—26. The Examiner finds that it is unclear from the wording of the claim whether treating a patient with a folate and a second medication to treat cardiovascular disease would fall within or outside the scope of the claims. Id. 4 As the sole independent claim, claim 35 is representative of the rejected claims. The remaining claims have not been argued separately and therefore fall with claim 35. 37 C.F.R. § 41.37(c)(l)(iv). 6 Appeal 2016-003411 Application 12/688,034 Appellants contend that the claims are not indefinite. Appeal Br. 3 Appellants argue that a proper reading of the claims means that only the use of additional vasodilators is excluded from the claims and that the use of mediations not related to the improvement of NO-mediated endothelial- dependent vasomotor responses is not within the metes and bounds of the claims. Appeal Br. 4. Appellants have the better position. The plain wording of the claims indicates that the method is limited to improving NO-mediated endothelial- dependent vasomotor response. Appeal Br. 14 (Claims Appx.) The first use of the transitional phrase “consisting of’ limits the steps employed for that specific method. Other methods used to treat other disorders are not within the scope of the claims and thus not restricted by the transitional phrase. Similarly, administration of drugs other than those relating to improving NO-mediated endothelial-dependent vasomotor response are not within the scope of the method or bound by the restrictive transitional phrase. We conclude that one skilled in the art would understand that administration of a drug such as a beta blocker5 in addition to a folate would be analogous to the situation in Norian Corp., where the inclusion of a spatula did not remove a kit containing claimed compounds from the scope of claims reciting the transitional phrase “consisting of.” Norian Corp. v. Stryker Corp., 363 F3d 1321, 1331-32 (Fed. Cir. 2004). Like the addition of a spatula in Norian Corp., the administration of another drug unrelated to improving NO- 5 We assume that beta blockers do not function by “improving NO-mediated endothelial-dependent vasomotor response.” 7 Appeal 2016-003411 Application 12/688,034 mediated endothelial-dependent vasomotor response does not affect whether a method is within the scope of the claims.6 Id. We conclude that substantial evidence does not support the Examiner’s conclusion that claim 35 is indefinite. SUMMARY We affirm the rejection based on 35 U.S.C. § 103(a). We reverse the rejection based on 35 U.S.C. § 112, second paragraph. 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 6 The Examiner’s indefmiteness rejection appears based at least in part on Appellants’ argument that van Etten does not render the claim obvious because it teaches the administration of 5-MTHF with serotonin. (Ans. 13— 14.) The Examiner contends that serotonin “does NOT achieve improving NO-mediated endothelial-dependent vasomotor responses” and that Appellants’ argument regarding van Etten is thus inconsistent with a construction of the claim permitting administration of 5-MTHF with other, non-vasodilating drugs. (Id.) We do not find the Examiner’s rationale persuasive, because Appellants in fact contend that serotonin is necessary to the vasodilating effect taught in van Etten. (Appeal Br. 7.) In short, Appellants and the Examiner disagree with regard to what van Etten teaches; however, this factual disagreement does not render the claims indefinite. 8 Copy with citationCopy as parenthetical citation