Ex Parte Fisch

Board of Patent Appeals and Interferences

Feb 22, 2012

10381225 (B.P.A.I. Feb. 22, 2012)

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.
10/381,225 03/21/2003 Harry Fisch 7202-229 9813
7590 02/23/2012
Ira J Schaefer , Esq.
Hogan & Hartson, L.L.P.
875 Third Avenue
New York, NY 10022
EXAMINER
JAGOE, DONNA A
ART UNIT PAPER NUMBER
1619
MAIL DATE DELIVERY MODE
02/23/2012 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 HARRY FISCH
__________

Appeal 2011-001265
Application 10/381,225
Technology Center 1600
__________

Before TONI R. SCHEINER, DEMETRA J. MILLS, and
STEPHEN WALSH, Administrative Patent Judges.

MILLS, Administrative Patent Judge.

DECISION ON APPEAL

This is an appeal under 35 U.S.C. § 134. The Examiner has rejected
the claims on the ground of obviousness. We have jurisdiction under 35
U.S.C. § 6(b).
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Application 10/381,225

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STATEMENT OF THE CASE
The following claim is representative and reads as follows:
7. A method for determining the need for a biopsy in a man having an
above-normal prostate specific antigen (PSA) level, said method comprising
the steps of:
a) measuring the PSA level of the man a first time and determining
that the PSA level is above-normal;
b) administering an effective amount of anti-inflammatory to said man
for a period of time deemed sufficient to reduce any inflammation of
the prostate; and
c) measuring the PSA level a second time; and either
i) determining that the PSA level is normal, in which case a
biopsy is not performed; or
ii) determining that the PSA level is above-normal, in which
case a biopsy is optionally performed.

Cited References

The Examiner relies on the following prior art references:

Okada et al., CORRELATION OF HISTOLOGICAL INFLAMMATION IN
NEEDLE BIOPSY SPECIMENTS WITH SERUM PROSTATE-SPECIFIC
ANTIGEN LEVELS IN MEN WITH NEGATIVE BIOPSY FOR PROSTATE
CANCER, 55ADULT UROLOGY 892-898 (2000).

Bates et al., Short course oral prednisolone therapy in chronic abacterial
prostatitis and prostatodynia: case reports of three responders and one
non-responder, 76 Sex. Transm. Inf. 398-400 (2000).

Brewster et al., Urology – A Handbook for Medical Students, BIOS
Scientific Publishers Limited (2001).

Appellant relies on the following prior art reference (see App. Br. 9):
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NCI (Phoenix5), Questions and Answers about PSA- From NCI, 9-7-2000.

Grounds of Rejection
Claims 7-13 and 38-41 are rejected under 35 U.S.C. § 103(a) as
obvious over Okada, Bates and Brewster.

FINDINGS OF FACT
The Examiner’s findings of fact are set forth in the Answer at pages 4-
7.
The following facts are highlighted.
1. Okada discloses that the degree of acute inflammation correlates
significantly with serum PSA levels. Okada further discloses that
histologically defined acute inflammation of the prostate is a
significant contributor to elevated PSA levels (see Okada Abstract.)
2. Okada discloses that in “the assessment of needle biopsy results”, it is
“helpful to evaluate the degree of histological inflammation… in
terms of the necessity of subsequent repeated biopsies.” (Id.)
3. Bates discloses that it is well known and conventional in chronic
abacterial prostatitis(CAP)/chronic pelvic pain syndrome (CPPS) to
treat with either antibiotics or nonsteroidal anti-inflammatory agents.
(See Bates p. 399, paragraph bridging cols. 1 and 2.)
4. Bates discloses four case studies of a subset of patients with persisting
symptoms after conventional therapy, in whom a continued course of
antibiotics, NSAIDs or prednisolone was also unsuccessful or
provided little or no symptom relief. (Id. at pp. 398-399, cases 1-4.)
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5. Brewster discloses that normal PSA levels increase with age. (See id.
at Table 9.6.)
6. Brewster discloses that serum PSA levels in the blood are often raised
in prostatitis. (Id. at 4.)
7. NCI discloses that there are many reasons for an elevated PSA,
including inflammation. If there are no other indicators that suggest
cancer the PSA test may be repeated regularly. If the PSA test results
increase or if a suspicious lump is detected, other diagnostic tests may
be performed. If cancer is suspected the only way to tell for sure is to
perform a biopsy.

Discussion
ISSUE
The Examiner concludes that
[i]t would have been obvious to administer an anti-inflammatory
agent in response to an elevated PSA motivated by the teaching of
Okada et al. that prostate volume and inflammation are most often
responsible for elevated serum PSA. To treat a suspected prostatitis
with an antibiotic and anti-inflammatory agent such as an NSAID
would have been obvious motivated by the teaching of Bates et al.
who teaches that the use of steroidal and non-steroidal anti-
inflammatory drugs. It would have been obvious to employ a waiting
period of 2 to 6 weeks before another PSA/ antigen test motivated by
the teaching of Okada et al. that prostate inflammation (prostatitis) is
frequently responsible for elevated PSA and the teaching of Bates et
al. who teach a length of treatment of about 3 months for prostatitis.
While the prior art does not explicitly teach away from performing a
biopsy, it is clearly disclosed that elevated PSA test results are
frequently caused by prostatitis, whether it be acute or chronic,
bacterial or nonbacterial, the treatment appears to be the same,
administration of an anti-inflammatory agent. The differences
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between the claimed invention and the prior art are encompassed in
the known variations in treatment available to a patient as directed by
a physician/urologist. One of ordinary skill in the art, in view of the
findings in the references listed above could have implemented the
claimed variation of the prior art and the claimed variation would
have been predictable.
One of ordinary skill in the art of urology would have found it
obvious to update the prior art method of performance of a biopsy in
response to an elevated PSA with the modern method of treating the
patient for prostatitis because it is frequently associated with elevated
PSA and perform routine treatments with known anti-inflammatory
agents 2 to 6 weeks before retesting the PSA and thereby gain,
predictably, the commonly understood benefits of such an adaptation,
that is, elimination of a potentially painful, harmful and expensive
procedure, such as a needle biopsy of the prostate.

(Ans. 5-6.)
Appellant argues that the heart of the present invention is to reduce
the need for biopsies, if they are not necessary after a course of treatment
with NSAIDS. (App. Br. 9.) Appellant argues that it is unclear how Bates
treatment period of 3 months suggest the claimed waiting period of 2 to 6
weeks. (Id. at 10.) Appellant further argues that Bates does not report
successful treatment of prostatitis with NSAID or prednisolone. (Id. at 8.)
Appellant argues contend that the Examiner has failed to properly cite and
address the NCI reference. (Id. at 9.) Appellant argues that the cited “prior
art teaches away from a biopsy not being performed. (Reply Br. 1.)
The issue is: Does the cited prior art support the Examiner’s
conclusion of obviousness of the pending claims?

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PRINCIPLES OF LAW
“In rejecting claims under 35 U.S.C. § 103, the examiner bears the
initial burden of presenting a prima facie case of obviousness. Only if that
burden is met, does the burden of coming forward with evidence or
argument shift to the applicant.” In re Rijckaert, 9 F.3d 1531, 1532 (Fed.
Cir. 1993) (citations omitted). In order to determine whether a prima facie
case of obviousness has been established, we consider the factors set forth in
Graham v. John Deere Co., 383 U.S. 1, 17 (1966): (1) the scope and content
of the prior art; (2) the differences between the prior art and the claims at
issue; (3) the level of ordinary skill in the relevant art; and (4) objective
evidence of nonobviousness, if present.
Moreover, “obviousness requires a suggestion of all limitations in a
claim.” CFMT, Inc. v. Yieldup Intern. Corp., 349 F.3d 1333, 1342 (Fed. Cir.
2003) (citing In re Royka, 490 F.2d 981, 985 (CCPA 1974)).
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
We find that the evidence before us supports a prima facie case of
obviousness of the pending claims. In particular, Okada discloses that the
degree of acute inflammation of the prostate correlates significantly with
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serum PSA levels. (FF1) Okada further discloses that histologically defined
acute inflammation of the prostate is a significant contributor to elevated
PSA levels (see Okada Abstract.) Okada discloses that in the assessment of
needle biopsy results, it is helpful to evaluate the degree of histological
inflammation in terms of the necessity of subsequent repeated biopsies. (Id.,
FF2)
Bates discloses that it is well known and conventional in chronic
abacterial prostatitis(CAP)/chronic pelvic pain syndrome (CPPS) to treat
with either antibiotics or nonsteroidal anti-inflammatory agents. (See Bates
p. 399, paragraph bridging cols. 1 and 2, FF3.)
Thus, one of ordinary skill in the art, aware that inflammation of the
prostate is correlated with increased PSA, and knowing from the cited
evidence that NSAIDs can be used conventionally to treat inflammation in
CAP, would have found it obvious to perform the steps of claim 7:
a) measuring the PSA level of the man a first time and determining
that the PSA level is above-normal;
b) administering an effective amount of anti-inflammatory to said man
for a period of time deemed sufficient to reduce any inflammation of
the prostate; and
c) measuring the PSA level a second time; and either
i) determining that the PSA level is normal, in which case a
biopsy is not performed; or alternatively
ii) determine that the PSA level is above-normal, in which case
a biopsy is optionally performed.

Appellant argues that the case studies of Bates teach away from
administering NSAIDs to treat prostate inflammation because they showed
unsuccessful results. (App. Br. 8.) We are not persuaded. Bates teaches
that, in most cases, it is conventional to treat prostate inflammation with
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NSAIDs. While it is acknowledged that Bates teaches that in a small subset
of patients with persisting symptoms after conventional therapy, that a
continued course of antibiotics, NSAIDs or prednisolone was unsuccessful
or provided little or no symptom relief, we do not find that Bates teaches
away from the use of NSAIDs to treat prostate inflammation in the first
instance to a group of patients that do respond to them.
Appellant argues that Okada teaches away from the claimed invention
because it teaches that persons of ordinary skill in the art should continue to
perform biopsies in all cases. (App. Br. 7.) Again we are not persuaded.
Okada teaches that it is helpful to evaluate the degree of histological or
prostate inflammation in terms of (i.e., to determine) the necessity of
subsequent repeated biopsies. (FF2). In other words, if inflammation of the
prostate is not found, there is no necessity to perform subsequent biopsies.
Thus biopsies need not be performed in all cases. We agree with the
Examiner that the claims, as written, do not exclude the performance of a
preliminary biopsy due to the open ending transitional term “comprising” in
the claims.
Appellant also relies on NCI, arguing that NCI teaches that “elevated
levels of PSA may indicate cancer, and the only way to tell for sure is to
perform a biopsy.” (App. Br. 9.) Again we are not convinced by this
argument. NCI discloses that there are many reasons for an elevated PSA,
including inflammation. (FF7.) NCI further teaches that if there are no
other indicators that suggest cancer the PSA test may be repeated regularly.
In this instance, NCI suggests only repeated PSA testing, no biopsy is
indicated. If the PSA test results increase or if a suspicious lump is detected,
other diagnostic tests may be performed. For example a urine test may be
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performed to determine if an infection is present. Therefore while other
diagnostic tests may be performed, they alternatively may not be performed
at the discretion of the physician. Thus a biopsy may not be performed.
Finally, Appellant argues that it is unclear how Bates treatment period
of 3 months suggest the claimed waiting period of 2 to 6 weeks. (App. Br.
10.) Bates discloses that the prostate gland of rats was injected with
methylprednisolone and it was determined that the amount of inflammation
of the prostate was reduced at 4 weeks. Thus Bates teaches waiting 4 weeks
before further inflammation level testing is conducted.
Patentability determinations are based on a preponderance of the
evidence. “After evidence or argument is submitted by the applicant in
response, patentability is determined on the totality of the record, by a
preponderance of the evidence with due consideration to persuasiveness of
argument.” In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992). In this
case, we find that the preponderance of the evidence supports a conclusion
of obviousness of the pending claims over the cited prior art. The rejection
is affirmed.

CONCLUSION OF LAW
The cited references support the Examiner’s obviousness rejection.
The rejection is affirmed.

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TIME PERIOD
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

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