Ex Parte Morgenlander

Board of Patent Appeals and Interferences

Feb 26, 2009

10932415 (B.P.A.I. Feb. 26, 2009)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________________

Ex parte JOEL MORGENLANDER,
Appellant
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Appeal 2008-5200
Application 10/932,4151
Technology Center 3700
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Decided:2 February 26, 2009
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Before CAROL A. SPIEGEL, ERIC GRIMES, and
RICHARD M. LEBOVITZ, Administrative Patent Judges.

SPIEGEL, Administrative Patent Judge.

DECISION ON APPEAL

1 Application 10/932,415, filed 2 September 2004, is a divisional of
application 10/341,643, filed 14 January 2003, which claims priority under
35 U.S.C. § 119 to provisional application 60/363,583, filed 12 March 2002.
The real party in interest is DUKE UNIVERSITY (Appellant's Brief On
Appeal Under 37 C.F.R. § 41.37, filed 6 August 2007 ("App. Br."), at 1).
2 The two month time period for filing an appeal or commencing a civil
action, as recited in 37 C.F.R. § 1.304, begins to run from the Decided date
shown on this page of the decision. The time period does not run form the
Mail date (paper delivery) or Notification date (electronic delivery).
Appeal 2008-5200
Application 10/932,415

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I. Statement of the Case
Appellant appeals under 35 U.S.C. § 134(a) from an Examiner's
rejection of all pending claims, claims 1, 3-13, and 20-27. We have
jurisdiction under 35 U.S.C. § 134. We AFFIRM.
The subject matter on appeal is directed to treatment of restless leg
syndrome ("RLS"), a "medical condition characterized by unpleasant limb
sensations that are typically precipitated by rest and relieved, at least
partially, by activity" ('415 application 1:7; 3:11-14). Claim 1 is illustrative
and reads (App. Br. 16):
A method of treating restless leg syndrome in a
patient in need of such treatment, the method
comprising applying positive pressure to an
extremity of the patient at a magnitude and for a
duration sufficient to combat restless leg
syndrome.
The Examiner relies on the following references3 of record
Pekanmäki US 4,989,589 Feb. 5, 1991
McWhorter US 5,263,473 Nov. 23,
1993

Evidente, "How to help patients with restless leg syndrome," Postgraduate
Medicine online, 105 (March 1999): 1-7, downloaded 15 November 2006
from http://www.postgradmed.com/issues/1999/03_09/evidente.htm.

Latorre, "Restless Legs Syndrome," eMedicine, 2 (October 2001):1-13,
downloaded 15 November 2006 from
http://web.archive.org/web/2002020202084434/http://www.emedicine.com/
neuro/topic509.htm.

A.N. Nicolaides, "Investigation of Chronic Venous Insufficiency: A
Consensus Statement," Circulation, 102 (2000): e126-e163.

3 No references to "et al." are made in this opinion.
Appeal 2008-5200
Application 10/932,415

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S.T. O'Keeffe, "Restless Legs Syndrome: A Review," Archives of Internal
Medicine, 156 (1996): 243-248.

Schul, "High Prevalence of Restless Leg syndrome In Patients With Chronic
Venous Insufficiency: A Story Untold," Abstract presented at the 2005
World Congress of Phlebology, Rio de Janiero, Brazil, downloaded 31 July
2008 from http://www.lafayetteveincenter.com/dr_shul_research.php?id=1.

The Examiner finally rejected claims 1, 6-9, 20, 21, and 25-27 as
unpatentable under 35 U.S.C. § 103(a) over O'Keeffe and Pekanmäki; and
claims 3-5, 10-13, and 22-24 over O'Keeffe, Pekanmäki, and McWhorter
(Ans.4 4-6). In addition, the Examiner rejected claims 1, 6, 7, 20, and 25 as
unpatentable under 35 U.S.C. § 102(b) over Pekanmäki in light of Schul in
the Answer (Ans. 3, 6-7).
In rebuttal, Appellant relies on the following evidence of record:
Declaration of Joel C. Morgenlander, M.D., dated August 10, 2005
("Morgenlander Decl. I").

Declaration of Jeffery H. Lawson, M.D., Ph.D., dated November 4, 2006
("Lawson Decl.").

Declaration of Mark A. Stacy, M.D., dated November 6, 2006 ("Stacy
Decl.").

Declaration of Joel C. Morgenlander, M.D., dated November 6, 2006
("Morgenlander Decl. II"), with supporting exhibits A-C, respectively:

Langer, "Relationships Between Symptoms and Venous Diseases:
The San Diego Population Study," Archives of Internal Medicine, 165
(2005):1420-1424.

Popkin, "Restless Legs," Journal of the American Geriatic Society, 11
(1963): 570-573.

4 Examiner's Answer mailed 21 November 2007 ("Ans.").
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MacLennan, "Hydroxyethylrutosides in Elderly Patients with Chronic
Venous Insufficiency: Its Efficacy and Tolerability," Gerontology, 40
(1994):45-52.

Supplemental Declaration of Joel C. Morgenlander, M.D., dated April 18,
2007 ("Morgenlander Decl. III"), with supporting exhibit A:

Winkelman, ed., "Recognizing and Treating Restless Legs Syndrome:
Current Standards," in a Supplement to The American Journal of
Medicine, 120 (2007):S1-S29.

Appellant has not separately argued the patentability of any of the
claims on appeal. Therefore, we decide this appeal on the basis of claim 1.
37 C.F.R. § 41.37(c)(1)(vii).
II. Findings of Fact ("FF")
The following findings of fact are supported by a preponderance of
the evidence of record.
[1] O'Keeffe teaches that the characteristic symptom of RLS is an
unpleasant sensation in the legs, which occurs at rest and is relieved
by movement (O'Keeffe 242, ¶ 2).
[2] O'Keeffe states the disorder is intermittent and that most cases of RLS
in the general population are mild (O'Keeffe 242, ¶ 2; 243, ¶ 4).
[3] According to O'Keeffe, "[w]alking is most effective at relieving leg
symptoms, but kicking, flexing, or massaging the legs may suffice in
milder episodes" (O'Keeffe 242, ¶ 2, emphasis added).
[4] Pekanmäki discloses a device for massaging body extremities, e.g.,
legs, in which pressures developing a massaging effect are produced
by the aid of a pressure source and a fluid (Pekanmäki 1:10-16).
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[5] Schul summarizes a study comparing the incidence of RLS in a
population of 174 patients reporting to a chronic venous insufficiency
("CVI") clinic to that occurring in a population of 98 healthy
individuals (Schul Background and Methods).
[6] According to Schul, about twice the percentage of the clinic patients
(62/174) had evidence of RLS than the healthy individuals (19/98)
(Schul Results).
[7] Schul reports that 97% of the clinic patients with evidence of RLS
also had CVI (60/62), but did not report what overall percentage of
the 174 clinic patients had CVI alone (Schul Results).
Other findings of fact follow below.
III. Discussion
A. The Examiner's findings and conclusions
The Examiner finds that O'Keeffe teaches a method of treating RLS
by massaging the legs and that Pekanmäki teaches a leg massaging device
and concludes that it would have been obvious to use the leg massaging
device of Pekanmäki in the method of O'Keeffe (Ans. 4, 8).
The Examiner also finds that Schul establishes that RLS is a common
overlapping clinical syndrome in patients with CVI. The Examiner finds
that, since Pekanmäki teaches massaging one or both legs of a patient with
CVI, Pekanmäki inherently teaches the claimed method of treating RLS
(Ans. 4-7). In addition to Schul, the Examiner finds that Latorre, Evidente,
and Nicolaides teach that patients with CVI also have symptoms of RLS
(Ans. 9-12). Thus, the Examiner finds that, given the association between
CVI and RLS, treating patients with CVI inherently treats patients with RLS
(Ans. 12-13).
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B. Appellant's position
Appellant argues that, absent a causal relationship between RLS and
CVI, there is absolutely nothing in the references of record to suggest the
claimed treatment method (App. Br. 4; Reply Br.5 3). Appellant submits the
declarations of Drs. Morgenlander, Lawson, and Stacy show that the current
state of the art does not recognize CVI as a primary cause of RLS and that
patients with CVI are no more likely to have RLS than members of the
population at large (App. Br. 6-9; Reply Br. 3).
C. Issues
Thus, the issues are (1) whether Appellant has shown there is nothing
in the combined teachings of O'Keeffe and Pekanmäki to suggest using the
device of Pekanmäki to massage the legs of patients with RLS and (2)
whether Appellant has shown that treating patients with CVI would not
inherently treat patients with RLS.
D. Legal principles
A claimed invention is not patentable if the subject matter of the
claimed invention would have been obvious to a person having ordinary skill
in the art. 35 U.S.C. § 103(a); KSR Int'l Co. v. Teleflex, Inc., 127 S.Ct. 1727,
1734 (2007); Graham v. John Deere Co. of Kansas City, 383 U.S. 1 (1966).
Facts relevant to a determination of obviousness include (1) the scope and
content of the prior art, (2) any differences between the claimed invention
and the prior art, (3) the level of skill in the art, and (4) relevant objective
evidence of obviousness or non-obviousness. KSR, 127 S.Ct. at 1734;
Graham, 383 U.S. at 17-18.

5 Appellant's Reply Brief on Appeal under 37 C.F.R. § 41.41 filed 18
January 2008 ("Reply Br.").
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"[T]he suggestion to modify the art to produce the claimed invention
need not be expressly stated in one or all of the references used to show
obviousness. 'Rather, the test is what the combined teachings of the
references would have suggested to those of ordinary skill in the art.'" Cable
Elec. Prods., Inc. v. Genmark, Inc., 770 F.2d 1015, 1025 (Fed. Cir. 1985)
(quoting In re Keller, 642 F.2d 413, 425 (CCPA 1981)).
Anticipation requires a prior art reference to describe every limitation
in a claim either explicitly or inherently. In re Schreiber, 128 F.3d 1473,
1477 (Fed. Cir. 1997). To be anticipated, the claimed subject matter must be
disclosed "clearly and unequivocally" in the reference. In re Arkley, 455
F.2d 586, 587 (CCPA 1972). Furthermore, inherent anticipation cannot be
based on possibilities or probabilities. Akami Tech., Inc. v. Cable &
Wireless Internet Serv., Inc., 344 F.3d 1186, 1192 (Fed. Cir. 2003) ("A claim
limitation is inherent in the prior art if it is necessarily present in the prior
art, not merely probably or possibly present."); In re Robertson, 169 F.3d
743, 745 (Fed. Cir. 1999) ("Inherent anticipation requires that the missing
descriptive material is 'necessarily present,' not merely probably or possibly
present, in the prior art").
E. Analysis
1. rejections under § 103(a)
Here, it is uncontested that O'Keeffe expressly teaches treating
patients having an RLS episode by massaging their legs (FF 3). Thus, we
agree with the Examiner that it would have been obvious to use a known leg
massaging device, such as that of Pekanmäki, to perform the massage. In
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other words, O'Keeffe expressly suggests the claimed treatment method.6 In
view of this express suggestion, it is unnecessary to consider the underlying
cause(s) of RLS. Similarly, a discussion of the teachings of McWhorter is
unnecessary to our decision. Therefore, based on the foregoing, we sustain
the rejections of claims 1, 6-9, 20, 21, and 25-27 as unpatentable under 35
U.S.C. § 103(a) over O'Keeffe and Pekanmäki; and, claims 3-5, 10-13, and
22-24 over O'Keeffe, Pekanmäki, and McWhorter.
2. rejection under § 102(b)
However, we do not agree with the Examiner that the method of
claims 1, 6, 7, 20, and 25 are anticipated by Pekanmäki.
[8] Drs. Lawson, Stacy, and Morgenlander each testified that RLS is a
neurological condition (Lawson Decl. ¶ 3; Stacy Decl. ¶ 4;
Morgenlander Decl. I-III, ¶3).
[9] Dr. Lawson testified that CVI and RLS are distinct disorders that may
occur concomitantly in some patients (Lawson Decl. ¶ 3).
[10] Dr. Morgenlander testified that patients with CVI are no more likely
to have RLS than members of the population at large (Morgenlander
Decl. II ¶ 4).
In short, the weight of the evidence of record fails to establish a causal
relationship between CVI and the occurrence of RLS. Thus, a method of
treating CVI does not necessarily provide a method of treating RLS. Based
on the foregoing, we reverse the rejection of claims 1, 6, 7, 20, and 25 under
§ 102(b) as anticipated by Pekanmäki.

6 We note that claim 27 is the only independent method claim which requires
that a device be used to apply pressure to, i.e., massage, an extremity of a
patient with RLS. However, no rejection of any pending claim under § 102
over O'Keeffe is before us.
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Application 10/932,415

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F. Conclusion
Appellant has not shown there is nothing in combined teachings of
O'Keeffe and Pekanmäki to suggest using the device of Pekanmäki to
massage the legs of patients with RLS. Appellant has shown that treating
patients with CVI would not inherently treat patients with RLS.
IV. Order
Upon consideration of the record, and for the reasons given, it is
ORDERED that the decision of the Examiner rejecting claims 1, 6-9,
20, 21, and 25-27 as unpatentable under 35 U.S.C. § 103(a) over O'Keeffe
and Pekanmäki is AFFIRMED;
FURTHER ORDERED that the decision of the Examiner rejecting
claims 3-5, 10-13, and 22-24 as unpatentable under 35 U.S.C. § 103(a) over
O'Keeffe, Pekanmäki, and McWhorter is AFFIRMED;
FURTHER ORDERED that the decision of the Examiner rejecting
claims 1, 6, 7, 20, and 26 as unpatentable under 35 U.S.C. § 102(b) over
Pekanmäki is REVERSED; and
FURTHER ORDERED that no time period for taking any subsequent
action in connection with this appeal may be extended under 37 C.F.R.
§ 1.136(a)(1)(iv).
AFFIRMED
ack

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