Ex Parte Yun et al

Board of Patent Appeals and Interferences

Mar 24, 2010

10962190 - (D) (B.P.A.I. Mar. 24, 2010)

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