Ex Parte Hirschman

Board of Patent Appeals and Interferences

May 28, 2004

09316624 (B.P.A.I. May. 28, 2004)

The opinion in support of the decision being entered today was not written
for publication and is not binding precedent of the Board.

Paper No. 19

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte SHALOM Z. HIRSCHMAN
__________

Appeal No. 2004-1212
Application No. 09/316,624
__________

ON BRIEF
__________

Before SCHEINER, GRIMES, and GREEN, Administrative Patent Judges.

GRIMES, Administrative Patent Judge.

DECISION ON APPEAL

This is a decision on appeal under 35 U.S.C. § 134 from the examiner’s
final rejection of claims 1-4, all of the claims remaining. Claim 1 is representative
and reads as follows:
1. A method of ameliorating a symptom of rheumatoid arthritis in a
patient suffering from rheumatoid arthritis, comprising parenterally administering
to said patient an effective symptom ameliorating amount of Product R in a range
from about 2.5 microliters to about 40 microliters per kilogram of body weight per
day in a pharmaceutically acceptable formulation.

Appeal No. 2004-1212 Page 2
Application No. 09/316,624

The examiner relies on the following reference:
Kochel 5,849,196 Dec. 15, 1998
Appellant relies on the following reference:
Friedland et al. (Friedland) 6,303,153 Oct. 16, 2001

Claims 1-4 stand rejected under 35 U.S.C. § 112, second paragraph, as
indefinite.
Claims 1-4 also stand rejected under 35 U.S.C. § 102(e) as anticipated by
Kochel.
We reverse both rejections.
Background
“RETICULOSE® emerged as an antiviral product in the 1930’s. . . .
Product R is a refinement of RETICULOSE® prepared by an improved
manufacturing process. It is a peptide nucleic acid preparation with defined
composition.” Specification, page 7. The specification defines Product R as the
product of either of two specific methods. See pages 10-12.
The specification discloses that Product R is an effective treatment for
autoimmune diseases, including rheumatoid arthritis. See pages 1, 2, and 12.
The specification describes a working example in which “[a] clinical trial to assess
the efficacy of Product R in patients suffering from rheumatoid arthritis (RA) has
been conducted.” Page 14. Treatment with Product R was reported to result in
decreased pain, swelling, inflammation, and morning stiffness, and improved joint
mobility and ability to carry out various activities. See pages 15-18.
Appeal No. 2004-1212 Page 3
Application No. 09/316,624

Discussion
Claim 1, the broadest claim on appeal, is directed to a method for
ameliorating a symptom of rheumatoid arthritis comprising parenterally
administering “an effective symptom ameliorating amount of Product R in a range
from about 2.5 microliters to about 40 microliters per kilogram of body weight per
day.” The examiner rejected the claims as indefinite and anticipated.
1. Definiteness
The examiner rejected the claims under 35 U.S.C. § 112, second
paragraph, on the basis that “[t]he metes and bounds of the phrase ‘effective
symptom ameliorating amount’ in claims 1 and 4 are unclear.” Examiner’s
Answer, page 3.
Appellant argues that “[t]here is nothing unclear about the claim language
‘an effective symptom ameliorating amount of Product R in a range from about
2.5 microliters to about 40 microliters per kilogram of body weight per day’[;] . . .
Product R is a substance in liquid form made according to a specific process
described in the application.” Appeal Brief, page 9.
We agree with Appellant that the claims mean what they say: an
“effective symptom ameliorating amount” of Product R is a daily dosage of 2.5 to
40 µl per kilogram of the patient’s body weight. The specification defines Product
R as the product resulting from one of two described procedures, and the claims
require administration of defined quantities of that (liquid) product. The claim
language that the examiner objected to – “effective symptom ameliorating
amount” – is essentially duplicative of the quantities expressly recited in the
Appeal No. 2004-1212 Page 4
Application No. 09/316,624

claim. Cf. Bristol-Myers Squibb Co. v. Ben Venue Labs., Inc., 246 F.3d 1368,
1375, 58 USPQ2d 1508, 1513 (Fed. Cir. 2001) (“[T]he expression ‘an
antineoplastically effective amount’ . . . [is an] expression of intended result [that]
essentially duplicates the dosage amounts recited in the claims. . . . The express
dosage amounts are material claim limitations; the statement of the intended
result of administering those amounts does not change those amounts or
otherwise limit the claim.”).
2. Anticipation
The examiner also rejected claims 1-4 as anticipated by Kochel, reasoning
that Kochel discloses that a composition of low molecular weight peptides (8-15
kD), derived from Reticulose® by filtration, is useful in treating rheumatoid
arthritis. See the Examiner’s Answer, page 4. The examiner concluded that
Kochel sets forth products derived from the known product
Reticulose® and methods of using that product, as claimed. The
methods Kochel used to produce the composition, as well as the
methods of treating rheumatoid arthritis, are very similar to those of
the claimed invention. Whether the products resulting from the
process are the same, is not clear, and the Office does not have
the facilities to perform such comprehensive analyses.

Id., page 5.
Appellant argues that the record shows that Product R is different from
Reticulose®. Specifically, Appellant cites Friedland, a commonly assigned U.S.
Patent, which compares the properties of Product R and Reticulose®. (Friedland’s
method of making Product R is the same as that disclosed on pages 10-11 of the
instant specification.)
Appeal No. 2004-1212 Page 5
Application No. 09/316,624

Among other things, Friedland discloses that the components of Product R
and Reticulose® have different molecular weight distributions, as well as different
ratios of UV absorbancies. See Table IV (column 10). Friedland also reports
that, although Kochel characterized the low molecular weight fraction of
Reticulose® as inhibiting phagocytosis by neutrophils (see Kochel, column 2,
lines 46-55), Product R does not have similar activity. See Table IV. Finally,
Friedland compares the starting materials for ten-liter batches of Reticulose® and
Product R (Table V) and concludes that “the initial protein concentration for the
RETICULOSE® preparation is twice as much as that for the Product R
preparation.” Column 10, lines 44-46.
We agree with Appellant that the evidence of record shows that the
Product R recited in the instant claims is different from the Reticulose®
preparation disclosed by Kochel. We therefore reverse the rejection under 35
U.S.C. § 102(e).
We note in closing that the examiner may have intended the rejection to
be based more on obviousness than anticipation: Kochel does not isolate any
low molecular weight fractions of Reticulose®, or describe how to do so, but the
section of Kochel cited by the examiner as teaching treatment of rheumatoid
arthritis states that a low molecular weight fraction of Reticulose® is “effective in
treating auto immune diseases.” Column 3, lines 1-11. If the examiner is of the
view that Kochel would have made obvious the instantly claimed method, even
though it does not anticipate, a rejection under 35 U.S.C. § 103 may be
appropriate.
Appeal No. 2004-1212 Page 6
Application No. 09/316,624

Before entering such a rejection, however, the examiner should consider
whether those of skill in the art would have been motivated to practice the
instantly claimed method; whether they would had a reasonable expectation of
success; whether the prior art was enabling for the low molecular weight fraction
discussed by Kochel; and whether the evidence is sufficient to show that such a
low molecular weight fraction would have been the same as the Product R
described in the instant specification. In respect of the latter consideration, the
examiner should note that the Friedland patent claims Product R as a
composition; the apparent novelty and nonobviousness of Product R are factors
that should be considered in any future prosecution. Cf. In re Ochiai, 71 F.3d
1565, 1569, 37 USPQ2d 1127, 1131 (Fed. Cir. 1995): “The process invention
Ochiai recites in claim 6 specifically requires use of none other than its new,
nonobvious acid as one of the starting materials. One having no knowledge of
this acid could hardly find it obvious to make any cephem using this acid as an
acylating agent, much less the particular cephem recited in claim 6.”
Appeal No. 2004-1212 Page 7
Application No. 09/316,624

Summary
The examiner has not adequately shown that those skilled in the art would
have considered the claims indefinite, or that the claimed method was identically
disclosed in the prior art. The rejections under 35 U.S.C. §§ 102(e) and 112,
second paragraph, are reversed.

REVERSED

Toni R. Scheiner )
Administrative Patent Judge )
)
)
) BOARD OF PATENT
Eric Grimes )
Administrative Patent Judge ) APPEALS AND
)
) INTERFERENCES
)
Lora M. Green )
Administrative Patent Judge )

EG/dym

Appeal No. 2004-1212 Page 8
Application No. 09/316,624

Myron Cohen ESQ
Cohen Pontani Lieberman & Pavane
551 Fifth Avenue
Suite 1210
New York, NY 10176