Ex Parte Yun et alDownload PDFBoard of Patent Appeals and InterferencesMar 24, 201010962190 - (D) (B.P.A.I. Mar. 24, 2010) Copy Citation UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE BOARD OF PATENT APPEALS AND INTERFERENCES __________ Ex parte ANTHONY JOONKYOO YUN and PATRICK YUARN-BOR LEE __________ Appeal 2009-012844 Application 10/962,190 Technology Center 1600 __________ Decided: March 24, 2010 __________ Before TONI R. SCHEINER, DONALD E. ADAMS, and STEPHEN WALSH, Administrative Patent Judges. SCHEINER, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134 from the final rejection of claims 1, 5, 6, 9, and 21-24, directed to a method of treating a subject for a condition caused by an autonomic nervous system abnormality. The claims have been rejected as anticipated. We have jurisdiction under 35 U.S.C. § 6(b). We reverse. Appeal 2009-012844 Application 10/962,190 STATEMENT OF THE CASE Claims 1, 5, 6, 9, and 21-24 are pending and stand rejected under 35 U.S.C. § 102(b) as anticipated by Harris,1 as evidenced by Pagani.2 Claims 1 and 23 are representative of the subject matter on appeal: 1. A method of treating a subject for a condition caused by an autonomic nervous system abnormality comprising modulating at least a portion of said subject’s autonomic nervous system by administering an effective amount of at least one aldosterone antagonist or analogue thereof to said subject to treat said subject for at least one of: cardiac rhythm disorders; atherosclerosis; coronary artery disease; hyperlipidemia; neurodegenerative conditions; neuroinflammatory conditions; orthopedic inflammatory conditions; lymphoproliferative conditions, autoimmune conditions; inflammatory conditions; infectious diseases, pulmonary conditions; transplant-related conditions, gastrointestinal conditions; endocrine conditions; genitourinary conditions; aging associated conditions; neurologic conditions; Th-2 dominant conditions; conditions that cause hypoxia; conditions that cause hypercarbia; conditions that cause hypercapnia; conditions that cause acidosis; conditions that cause academia, pediatric-related conditions; pregnancy conditions, OB- GYN conditions; sudden death syndromes, cancer; fibrosis; post-operative recovery conditions; post-procedural recovery conditions; chronic pain; disorders of thermoregulation; cyclic vomiting syndrome; an autonomic dysregulation condition; and trauma; wherein said modulating results in substantially equal parasympathetic and sympathetic functions in at least a portion of said autonomic nervous system. 23. The method of claim 1, further comprising administering an effective amount of at least one non-aldosterone antagonist agent. 1 US 4,374,829, issued February 22, 1983 to Harris et al. 2 Massimo Pagani & Daniela Lucini, Autonomic dysregulation in essential hypertension: insight from heart rate and arterial pressure variability, 90 AUTONOMIC NEUROSCIENCE: BASIC AND CLINICAL 76-82 (2001). 2 Appeal 2009-012844 Application 10/962,190 In a Response to Election/Restriction dated April 26, 2007, Appellants elected “[a]n autonomic dysregulation condition” as the condition to be modulated, and “beta-blockers” as the non-aldosterone antagonist agent to be administered in addition to the aldosterone-antagonist (see claims 23, 24). It is our understanding that the claims have been examined only to the extent that they read on the elected species. ISSUE According to the Examiner, Harris “discloses methods of successful treatment of hypertension” (Ans. 4), “a condition characterized by autonomic dysregulation” (id. at 5), “with therapeutically effective amounts of atenolol (a beta-blocker) and spironolactone (an aldosterone antagonist)” (id. at 4). The Examiner acknowledges that Harris doesn’t explicitly teach that treatment results in substantially equal parasympathetic and sympathetic functions in at least a portion of the autonomic nervous system, but asserts that Pagani provides evidence that “this would nonetheless be an inherent outcome induced by administering atenolol and spironolactone in the successful treatment of hypertension” (id. at 6). Appellants contend that “[t]he Examiner has not provided a basis in fact to reasonably support the determination that the allegedly inherent characteristic necessarily flows from the teachings of . . . Harris” (App. Br. 7), and “mere possibilities or even probabilities are not enough to support a finding of anticipation” (id. at 8). The issue raised by this rejection is whether the evidence of record is sufficient to establish that treatment of hypertension with spironolactone and atenolol inherently results in substantially equal parasympathetic and sympathetic functions in at least a portion of the autonomic nervous system. 3 Appeal 2009-012844 Application 10/962,190 Findings of Fact FF1 Harris discloses “carboxyalkyl dipeptides and derivatives thereof which are useful as [angiotension] converting enzyme [ACE] inhibitors and as antihypertensives” (Harris, col. 1, ll. 57-60). FF2 Harris teaches that carboxyalkyl dipeptide ACE inhibitors “can also be administered in combination with other antihypertensives and/or diuretics,” such as: [A]miloride, atenolol, bendroflumethiazide, chlorothalidone, chlorothiazide, clonidine, cryptenamine acetates and cryptenamine tannates, deserpidine, diazoxide, guanethidene sulfate, hydralazine hydrochloride, hydrochlorothiazide, hydroflumethiazide, metolazone, metoprololtartate, methyclothiazide, methyldopa, methyldopate hydrochloride, minoxidil, pargyline hydrochloride, polythiazide, prazosin, propranolol, rauwolfia serpentina, rescinnamine, reserpine, sodium nitroprusside, spironolactone, timolol, trichlormethiazide, trimethophan camsylate, benzthiazide, quinethazone, ticrynafan, triamterene, acetazolamide, aminophylline, cyclothiazide, ethacrynic acid, furosemide, merethoxyline procaine, sodium ethacrynate, and the like, as well as admixtures and combinations thereof. (Harris, col. 9, l. 62 to col. 10, l. 12 (boldface emphasis added).) FF3 The Examiner finds that Harris “discloses methods of successful treatment of hypertension” (Ans. 4), “a condition characterized by autonomic dysregulation” (id. at 5), “with therapeutically effective amounts of atenolol (a beta-blocker) and spironolactone (an aldosterone antagonist)” (id. at 4). FF4 Pagani teaches that “the exact causal mechanism(s) [of essential hypertension] are far from being fully understood” (Pagani 76, col. 2), but “it appears that available evidence supports the hypothesis that in essential 4 Appeal 2009-012844 Application 10/962,190 hypertension, there is an increased sympathetic and reduced vagal cardiac drive coupled with an enhancement of vaso-motor sympathetic modulation” (id. at 80, col. 2). FF5 According to Pagani, “[b]eta-adrenergic receptor blockers and ACE inhibitors, to a certain degree, might share the . . . potentially beneficial[ ] effect of enhancing vagal and reducing sympathetic drive” (Pagani 79, col. 2). Principles of Law “If the prior art reference does not expressly set forth a particular element of the claim, that reference still may anticipate if that element is ‘inherent’ in its disclosure.” In re Robertson, 169 F.3d 743, 745 (Fed. Cir. 1999). “[T]he examiner must provide some evidence or scientific reasoning to establish the reasonableness of the examiner’s belief that the functional limitation is an inherent characteristic of the prior art” before the burden is shifted to Applicants to disprove the inherency. Ex parte Skinner, 2 USPQ2d 1788, 1789 (BPAI 1986). “Inherency . . . may not be established by probabilities or possibilities. The mere fact that a certain thing may result from a given set of circumstances is not sufficient.” Robertson, 169 F.3d at 745 (quoting Continental Can Co. v. Monsanto Co., 948 F.2d 1264, 1269 (Fed. Cir. 1991)) (internal quotation marks and citations omitted). Analysis In a nutshell, we agree with the Examiner that Pagani provides sufficient evidence to establish that beta-blockers modulate the autonomic nervous system in some manner. However, Pagani is tentative, at best, in 5 Appeal 2009-012844 Application 10/962,190 suggesting that beta-blockers might exert their effects by enhancing vagal (i.e. parasympathetic) and reducing sympathetic drive (FF4, FF5). That being the case, we don’t agree with the Examiner that the evidence of record is sufficient to establish the effect administering atenolol, a beta-blocker, would have on the balance between sympathetic and parasympathetic drives, especially when administering it in combination with one of Harris’ carboxyalkyl dipeptide ACE inhibitors and the aldosterone antagonist, spironolactone (FF1-FF3). Conclusions of Law The evidence of record is not sufficient to establish that treatment of hypertension with spironolactone and atenolol inherently results in substantially equal parasympathetic and sympathetic functions in at least a portion of the autonomic nervous system. The rejection of claims 1, 5, 6, 9, and 21-24 as anticipated by Harris is reversed. REVERSED cdc BOZICEVIC, FIELD & FRANCIS LLP 1900 UNIVERSITY AVENUE SUITE 200 EAST PALO ALTO, CA 94303 6 Copy with citationCopy as parenthetical citation