Ex Parte Brunner

Board of Patent Appeals and Interferences

Feb 1, 2011

11979450 (B.P.A.I. Feb. 1, 2011)

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.
11/979,450 11/02/2007 Hans R. Brunner 7571/80526DIV 1639
66991 7590 02/01/2011
LAW OFFICE OF MICHAEL A. SANZO, LLC
15400 CALHOUN DR.
SUITE 125
ROCKVILLE, MD 20855
EXAMINER
GEMBEH, SHIRLEY V
ART UNIT PAPER NUMBER
1628
MAIL DATE DELIVERY MODE
02/01/2011 PAPER
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.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte HANS R. BRUNNER
__________

Application 11/979,450
Appeal 2010-009422
Technology Center 1600
__________

Before TONI R. SCHEINER, DEMETRA J. MILLS, and
LORA M. GREEN, Administrative Patent Judges.

GREEN, Administrative Patent Judge.

DECISION ON APPEAL1
This is a decision on appeal under 35 U.S.C. § 134 from the
Examiner’s rejection of claims 30-49. We have jurisdiction under 35 U.S.C.
§ 6(b).

1 The two-month time period for filing an appeal or commencing a civil
action, as recited in 37 C.F.R. § 1.304, or for filing a request for rehearing,
as recited in 37 C.F.R. § 41.52, begins to run from the “MAIL DATE”
(paper delivery mode) or the “NOTIFICATION DATE” (electronic delivery
mode) shown on the PTOL-90A cover letter attached to this decision.
Appeal 2010-009422
Application 11/979,450

2
STATEMENT OF THE CASE
Claim 30 is representative of the claims on appeal, and reads as
follows:
30. In a method of treating a patient for pain or inflammation wherein said
patient is at increased risk of a thromboembolic event due solely to their
taking a cyclooxygenase-2 (COX-2) inhibitor for pain or inflammation, the
improvement comprising cotimely administering to said patient, a
therapeutically effective amount of a thromboxane A2 receptor antagonist.

The following grounds of rejection are before us for review:
I. Claims 30-49 stand rejected under 35 U.S.C. § 112, first
paragraph, as failing to meet the written description requirement
for containing new matter.
II. Claims 30-38 and 40-48 stand rejected under 35 U.S.C. § 102(e) as
being anticipated by Scolnick.2
III. Claims 30-49 stand rejected under 35 U.S.C. § 103(a) as being
rendered obvious by the combination of Scolnick and Patel.3
We affirm all the above rejections.
ISSUE (I)
Has the Examiner demonstrated by a preponderance of the evidence
that the addition of the term “solely” to independent claims 30 and 40 is not
supported by the disclosure as filed?

2 Scolnick, US 2002/0016342 A1, published February 7, 2002.
3 Patel, US 6,589,973 B1, issued July 8, 2003.
Appeal 2010-009422
Application 11/979,450

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FINDINGS OF FACT
FF1 The Specification teaches that the “invention is directed to
compositions containing both a cyclooxygenase-2 (COX-2) inhibitor and a
thromboxane A2 receptor antagonist.” (Spec. 1.)
FF2 Specifically, according to the Specification, the “present invention is
based upon the concept that the cardiovascular risks associated with the
administration of COX-2 specific inhibitors can be avoided by co-
administering an agent that blocks the activation of the thromboxane A2
receptor by its ligand.” (Id. at 2.)
FF3 The Specification teaches that the conditions that may be treated
“include inflammation (e.g., that associated with arthritis); pain (e.g., pain
associated with headache, muscle pain, or post-surgical pain); and
cardiovascular conditions (e.g., arterial or venous thrombosis, angina, or
hypertension).” (Id. at 3.)
FF4 The Examiner’s statement of the written description rejection may be
found at pages 3-4 of the Answer.
FF5 Specifically, the Examiner finds that the addition of the term “solely”
to independent claims 30 and 40 is not supported by the disclosure as filed.
(Ans. 4.)

PRINCIPLES OF LAW
As stated in TurboCare Div. of Demag Delaval Turbomachinery
Corp. v. General Elec. Co., 264 F.3d 1111, 1118 (Fed. Cir. 2001):
The written description requirement and its corollary, the new
matter prohibition of 35 U.S.C. § 132, both serve to ensure that
the patent applicant was in full possession of the claimed
Appeal 2010-009422
Application 11/979,450

4
subject matter on the application filing date. When the
applicant adds a claim or otherwise amends his specification
after the original filing date . . ., the new claims or other added
material must find support in the original specification.

The test for determining whether a specification is sufficient to
support a particular claim “is whether the disclosure of the application relied
upon ‘reasonably conveys to the artisan that the inventor had possession at
that time of the later claimed subject matter.’” Ralston Purina Co. v. Far-
Mar-Co, Inc., 772 F.2d 1570, 1575 (Fed.Cir.1985) (quoting In re Kaslow,
707 F.2d 1366, 1375 (Fed.Cir.1983)). Thus, “[i]t is not necessary that the
application describe the claim limitations exactly,…, but only so clearly that
persons of ordinary skill in the art will recognize from the disclosure that
appellants invented processes including those limitations.” In re Wertheim,
541 F.2d 257, 262 (CCPA 1976) (citation omitted); see also Purdue Pharma
L.P. v. Faulding, Inc., 230 F.3d 1320, 1323 (Fed. Cir. 2000) (“In order to
satisfy the written description requirement, the disclosure as originally filed
does not have to provide in haec verba support for the claimed subject
matter at issue.”).

ANALYSIS
The Appellant asserts that the Specification as filed supports the
concept of administering COX-2 inhibitor and a thromboxane A2 receptor
antagonist for pain or inflammation solely to those patients at increased risk
of a thromboembolic event due solely to their taking the COX-2 inhibitor.
(App. Br. 8.) The Appellant cites pages 2 and 4 of the Specification, which
Appeal 2010-009422
Application 11/979,450

5
discuss that COX-2 inhibitors increase the risk of adverse cardiovascular
events. (Id.)
We agree with the Examiner that the addition of “solely” to the
independent claims constitutes new matter. While we agree that the
Specification teaches that the administration of COX-2 inhibitors increase
the risk of adverse cardiovascular events, the Specification never discusses,
suggests, or teaches determining a patient’s risk factors before
administration of the COX-2 inhibitor and the thromboxane A2 receptor
antagonist. Stated differently, the claims implicitly require a step of
determining a patient’s risk of a having a thromboembolic event, which step
is not taught or suggested by the disclosure as filed.
We note further that the Specification specifically teaches
administration of a COX-2 inhibitor and a thromboxane A2 receptor
antagonist for cardiovascular conditions (e.g., arterial or venous thrombosis,
angina, or hypertension) (FF3), and thus again does not support Appellant’s
assertion that the skilled artisan would understand that the disclosure as filed
supports the exclusion of that group of patents, so as to have possession of
the method as presently claimed.

CONCLUSION OF LAW
We conclude that the Examiner demonstrated by a preponderance of
the evidence that the addition of the term “solely” to independent claims 30
and 40 is not supported by the disclosure as filed. We thus affirm the
rejection of claims 30-49 under 35 U.S.C. § 112, first paragraph, as failing to
meet the written description requirement for containing new matter.
Appeal 2010-009422
Application 11/979,450

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ISSUE (II and III)
Has the Examiner established by a preponderance of the evidence that
Scolnick anticipates the method of claim 30?

FINDINGS OF FACT
FF6 The Examiner’s statement of the anticipation rejection may be found
at pages 4-5 of the Answer. As Appellant does not argue the claims
separately, we focus our analysis on claim 30, and claims 31-38 and 40-48
stand or fall with that claim. 37 C.F.R. § 41.37(c)(1)(vii).
FF7 The Examiner finds that Scolnick teaches administration of a
thromboxane A2 receptor inhibitor (i.e., antagonist) with a COX-2 inhibitor
for the treatment of pain and inflammation. (Ans. 4; see also id. at 7.)
FF8 Specifically, Scolnick teaches a method for “the treatment or
prophylaxis of COX-2-mediated conditions in patients who are at risk of
developing thromboembolic events which comprises administering . . .a
COX-2 selective inhibitor and a cardiovascular protective amount of a
thromboxane inhibitor.” (Scolnick, ¶8.)
FF9 Scolnick defines
“Patients who are at risk of developing thromboembolic events”
include those with a familial history of, or genetically
predisposed to, thromboembolic disorders, who have had
ischemic stroke, transient ischemic stroke, myocardial
infarction, and those with unstable angina pectoris or chronic
stable angina pectoris and patients with altered
prostacyclin/thromboxane A2 homeostasis or higher than
normal thromboxane A2 levels leading to increase risk for
thromboembolism, including patients with diabetes and
rheumatoid arthritis.

Appeal 2010-009422
Application 11/979,450

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(Id. at ¶15.)
FF10 Scolnick teaches that the COX-2 mediated condition may be
osteoarthritis, rheumatoid arthritis, cancer, and Alzheimer’s disease. (Id. at
¶11.)
FF11 The Examiner’s statement of the obviousness rejection may be found
at pages 5-6 of the Answer.

PRINCIPLES OF LAW
During prosecution before the Office, claims are to be given their
broadest reasonable interpretation consistent with the Specification as it
would be interpreted by one of ordinary skill in the art. In re American
Academy Of Science Tech Center, 367 F.3d 1359, 1364 (Fed. Cir. 2004).
“An essential purpose of patent examination is to fashion claims that are
precise, clear, correct, and unambiguous. Only in this way can uncertainties
of claim scope be removed, as much as possible, during the administrative
process.” In re Zletz, 893 F.2d 319, 322 (Fed. Cir. 1989). Moreover, it is
during prosecution that applicants have “the opportunity to amend the claims
to obtain more precise claim coverage.” American Academy, 367 F.3d at
1364.

ANALYSIS
The Appellant argues that “Scolnick only suggests that a very specific
subset of patients taking COX-2 inhibitors, i.e., people already at risk of
having a thromboembolic event, can benefit by also taking a thromboxane
A2 receptor antagonist.” (App. Br. 9.) According to Appellant, the claimed
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Application 11/979,450

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method is drawn to a completely different group of patients, that is, “a group
where risk has been created solely due to the ingestion of COX-2 inhibitors.”
(Id. at 10.) Specifically, Appellant asserts that Scolnick cannot anticipate
the claimed method as Scolnick does not teach or suggest that administration
of COX-2 inhibitors lead to an increased risk of a thromboembolic event.
(See Reply Br. 1-3.)
If we were to accept Appellant’s argument, we would have to interpret
“solely” in claim 30 as excluding any patient with any increased risk of a
thromboembolic event, such as risk factors due to the disease being treated,
family history, genetic risk factors, etc. As discussed above, however, the
term “solely” does not appear in the disclosure as filed, and as such, has not
been defined by the disclosure as filed. We interpret “solely” in view of the
teachings of the Specification as only excluding those patients who have
known cardiac conditions, such as arterial or venous thrombosis, angina, or
hypertension. (See FF3.) That is, the Specification teaches that the
conditions that may be treated “include inflammation (e.g., that associated
with arthritis); pain (e.g., pain associated with headache, muscle pain, or
post-surgical pain); and cardiovascular conditions (e.g., arterial or venous
thrombosis, angina, or hypertension),” thus we interpret “solely” as
separating those patients suffering from pain and inflammation, such as from
arthritis, from those having a cardiovascular condition. (Id.)
Given that interpretation, claim 30 encompasses the treatment of
arthritis patients, which is also a patient group that Scolnick teaches can
benefit from their method of treating COX-2 mediated through the
administration of a COX-2 selective inhibitor and a thromboxane A2
Appeal 2010-009422
Application 11/979,450

9
inhibitor. (See FF9.) We thus find that the Examiner has established that
Scolnick anticipates the method of claim 30.
As to the obviousness rejection, Appellant reiterates the arguments
made with respect to the anticipation rejection. (See App. Br. 10.) We thus
affirm that rejection as well for the reasons set forth above.

CONCLUSION OF LAW
We conclude that the Examiner has established by a preponderance of
the evidence that Scolnick anticipates the method of claim 30.
We thus affirm the rejection of claims 30-38 and 40-48 under 35
U.S.C. § 102(e) as being anticipated by Scolnick, as well as the rejection of
claims 30-49 under 35 U.S.C. § 103(a) as being rendered obvious by the
combination of Scolnick and Patel.

Appeal 2010-009422
Application 11/979,450

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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

alw

LAW OFFICE OF MICHAEL A. SANZO, LLC
15400 CALHOUN DR.
SUITE 125
ROCKVILLE, MD 20855