Ex parte Gante et al.

Board of Patent Appeals and Interferences

May 6, 2002

08642268 (B.P.A.I. May. 6, 2002)

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for publication and is not binding precedent of the Board.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. 28

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte JOACHIM GANTE,
HORST JURASZYK,
PETER RADDATZ,
HANNS WURZIGER,
SABINE BERNOTAT-DANIELOWSKI, and
GUIDO MELZER
__________

Appeal No. 2000-0600
Application No. 08/642,268
__________

ON BRIEF1
__________

Before WILLIAM F. SMITH, ADAMS, and MILLS, Administrative Patent Judges.

ADAMS, Administrative Patent Judge.

DECISION ON APPEAL

This is a decision on the appeal under 35 U.S.C. § 134 from the examiner’s
final rejection of claims 1, 2, 5-11, and 13-19. The examiner has indicated that
claim 3, the only other pending claim, is allowed. See Final Office Action, page 3.

1 We recognize appellants’ request for an oral hearing (Paper No. 23, received June 23, 1999).
However, in accordance with 37 CFR §1.194(c), the Board decided that an oral hearing was not
necessary in this appeal.
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Application No. 08/642,268

Claim 1 is illustrative of the subject matter on appeal and is reproduced below:

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The examiner does not rely on prior art.

GROUNDS OF REJECTION

Claims 1, 2, 5-11, and 13-19 stand rejected under 35 U.S.C. § 112, first
paragraph, as based on a specification that fails to enable the subject matter of the
claimed invention.
Claims 7-11 and 18-19 stand rejected under 35 U.S.C. § 112, first
paragraph, as based on a specification that fails to enable the use of the subject
matter of the claimed invention.
Claims 1, 2, 5-11, and 13-19 stand rejected under 35 U.S.C. § 112, second
paragraph, as indefinite for failing to particularly point out and distinctly claim the
subject matter of the claimed invention.
Claims 7-11 stand rejected under 35 U.S.C. § 112, second paragraph, as
indefinite for failing to particularly point out and distinctly claim the subject matter of
the claimed invention.
We reverse.
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Application No. 08/642,268

DISCUSSION
THE REJECTIONS UNDER 35 U.S.C. § 112, FIRST PARAGRAPH:
Claims 1, 2, 5-11, and 13-19:
The examiner finds (Answer, page 5) appellants “provide no reasonable
assurance that [the] piperazion,[ ]piperidino species having ‘het’ at R2 and/or R3 will
all share the requisite profile of activity needed to be operative for practicing the
invention.” According to the examiner (id.) while certain in vitro tests are disclosed
on pages 4-5 of the specification it has “not been shown if a variety of hetero rings
at R2,[ ]R3 have been tested or just one or two of the working examples directed to
a much narrower scope- ie.[ ]piperidino,[ ]pyridyl,[ ]thienyl and furyl in the R3 group.”
We note that the examiner provides no evidence to support her position,
instead, the examiner simply concludes that the specification is not sufficient to
support the claimed invention. With reference to In re Marzocchi, 439 F.2d 220,
224, 169 USPQ 367, 370 (CCPA 1971), appellants argue (Brief, page 6) “that the
burden of proof on this issue has been prematurely shifted to [a]ppellants.” We
agree with appellants.
Whether the disclosure is enabling, is a legal conclusion based on several
underlying factual inquiries. See In re Wands, 858 F.2d 731, 735, 736-37, 8
USPQ2d 1400, 1402, 1404 (Fed. Cir. 1988). As set forth in Wands, the factors to
be considered in determining whether a claimed invention is enabled throughout its
scope without undue experimentation include the quantity of experimentation
necessary, the amount of direction or guidance presented, the presence or absence
of working examples, the nature of the invention, the state of the prior art, the relative
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Application No. 08/642,268

skill of those in the art, the predictability or unpredictability of the art, and the breadth
of the claims.
We find no analysis of the Wands factors by the examiner. Instead, we find
only the examiner’s unsupported conclusions as to why the specification does not
enable the claimed invention. We remind the examiner that nothing more than
objective enablement is required, and therefore it is irrelevant whether this teaching
is provided through broad terminology or illustrative examples. Marzocchi, 439 F.2d
at 223, 169 USPQ at 369. In the absence of a fact-based statement of a rejection
based upon the relevant legal standards, the examiner has not sustained her initial
burden of establishing a prima facie case of non-enablement. As set forth by
appellants’ (Brief, page 7):
A disclosure which contains representative examples which provide
reasonable assurance to one of ordinary skill in the art that the
compounds falling within the scope of the claim can be made and
possess utility is all that is required, absent any reasons given as to
why the statements made in the specification are not accurate.

We agree. The burden of proof does not shift to appellant until the examiner
first meets her burden. Marzocchi, 439 F.2d at 223-224, 169 USPQ at 369-370.
On this record, the examiner has not met her burden.
Accordingly, we reverse the examiner’s rejection of claims 1, 2, 5-11, and
13-19 under 35 U.S.C. § 112, first paragraph.
Claims 7-11 and 18-19:

According to the examiner (Answer, page 5) the “[s]pecification does not
adequately teach one ‘how to use’ the instant compounds for all disorders
apparently embraced by the method claims.” The examiner finds (Answer, page 5)
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Application No. 08/642,268

that the specification makes reference to a number of disorders, including, “(but …
not limited to) thromboses,[ ]osteolytic disorders, kidney failure [and] antitumor
agents.” However, the examiner finds (Answer, pages 5-6) that the “nature of
testing relied on in the specification does not appear to be art-recognized for
treating all such disorders.” In this regard, the examiner makes reference (Answer,
page 6) to two prior art references – Muller and Smith. However, as set forth on
page 3 of the Answer, “[n]o prior art is relied upon by the examiner in the rejection of
the claims under appeal.” As set forth in In re Hoch, 428 F.2d 1341, 1342 n.3, 166
USPQ 406, 407 n.3 (CCPA 1970) (“[w]here a reference is relied on to support a
rejection, whether or not in a ‘minor capacity,’ there would appear to be no excuse
for not positively including the reference in the statement of the rejection”).
Accordingly, the examiner’s reliance on Muller and Smith is in error.
Notwithstanding the examiner’s error, appellants responded to the
examiner’s argument (Reply Brief, page 4), therefore, we will consider the
references to the extent that the examiner and appellants have relied on them. For
emphasis, the following quote reproduces in full the examiner’s position relative to
the cited references (Answer, page 6), “[a]t best,[ ]Muller, provided in an earlier
action, suggests a correlation exists for the treatment of thrombosis-see second [to
the] last paragraph on p.[ ]113. Note also Smith cited in the specification,[ ]p.[ ]4, for
an example of a ligand binding assay that can be used does not make such
assertions. See page 12270.”
While we find the examiner’s point less than clear, we find appellants’
response compelling. According to appellants’ (Reply Brief, page 4):
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The [e]xaminer’s Answer alleges that the assays disclosed in
the specification and the examples in the art of record (e.g., Muller)
are only art-recognized for, at best, the treatment of platelet
aggregation and thrombosis (as is recited, e.g., in cla[i]m 8).
However, the [e]xaminer has provided no reasons to cast doubt on
appellants’ assertion that these models are, in fact, suitable for
determining how to treat the diseases encompassed by the claims
(e.g., thromboses, osteolytic disorders, kidney failure, tumors). As
was discussed in the Appeal Brief, the burden lies with the [e]xaminer
to provide evidence which raises doubt about what applicants have
disclosed as to the utility of the invention (In re Marzochi et al[.]), and in
the absence of such evidence, the rejection cannot be maintained.

Here again we find no analysis of the Wands factors by the examiner.
Instead, we find only the examiner’s unsupported conclusions as to why the
specification does not enable the claimed invention. As set forth above, in the
absence of a fact-based statement of a rejection based upon the relevant legal
standards, the examiner has not sustained her initial burden of establishing a prima
facie case of non-enablement. We recognize appellants’ argument (Brief, page 7):
Again, the [e]xaminer appears to set forth an initial burden upon
[a]ppellants to provide tests as to the applicability of the compounds
to many of the several embodiments of the claims. Appellants urge
that such burden is unfounded in the absence of reasons for doubting
the objective truth of the statements in the specification on how to
conduct the methods, explanations why the truth or accuracy of such
statements are doubted and acceptable evidence or reasoning to
back up the assertions that such statements are insufficient.”

We again remind the examiner that the burden of proof does not shift to appellant
until the examiner first meets her burden. Marzocchi, 439 F.2d at 223-224, 169
USPQ at 369-370. In our opinion, the examiner has not met her burden on this
record.
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Application No. 08/642,268

Having determined that the examiner has not met her burden of established
a prima facie case of non-enablement, we find it unnecessary to discuss the Melzer
Declaration, relied on by appellants to rebut any such prima facie case.
Accordingly, we reverse the rejection of claims 7-11 and 18-19 under
35 U.S.C. § 112, first paragraph.
THE REJECTIONS UNDER 35 U.S.C. § 112, SECOND PARAGRAPH:
The legal standard for indefiniteness under 35 U.S.C § 112, second
paragraph, is whether a claim reasonable apprises those of skill in the art of its
scope. See, Amgen Inc. v. Chugai Pharmaceutical Co., Ltd. 927 F.2d 1200, 1217,
18 USPQ2d 1016, 1030 (Fed. Cir. 1991).
Claims 1, 2, 5-11, and 13-19:
According to the examiner (Answer, page 3) the “[s]cope of ‘solvates’ as
recited in … [the] claims is unknown.” The examiner finds (id.) “[g]enerally not all
solvents can form solvates with all compounds … [and] it is not routine for any and
every type of solvent for form solvate(s) with specific compounds.” According to the
examiner (Answer, page 4) “[i]n the absence of any guidance in the specification …
or in any relevant prior art,[ ]one cannot readily determine what is and what is not
within the instant scope of solvates.”
In response, appellants argue (Brief, page 3) “[t]hat all solvents cannot form
solvates with all compounds is not seen to be relevant herein. The relevant inquiry is
whether it would be known to one of ordinary skill in the art what solvents form
physiologically acceptable solvates with the compounds of formula I.” In this regard,
appellants argue (Brief, page 4), with reference to Hybritech Inc. v. Monoclonal
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Application No. 08/642,268

Antibodies, Inc., 802 F.2d 1367, 1385, 231 USPQ 81, 94 (Fed. Cir. 1986), “the
selection of useful solvents and formation of solvates is highly routine in this art.
Appellants need not provide in their specification a description of matter which is
common and routine in the art. A ‘patent need not teach, and preferably omits, what
is well known in the art.’” According to appellants’ (Reply Brief, page 2) “[b]ecause
selection of the appropriate solvents for forming solvates was routine to one of
ordinary skill in the art, the metes and bounds of the term were reasonably
determinable using only ordinary skill in the art.” We agree.
Accordingly, we reverse the rejection of claims 1, 2, 5-11, and 13-19 under
35 U.S.C. § 112, second paragraph.
Claims 7-11:
According to the examiner (Answer, page 4) the “[s]cope of method claims
7-11 is unknown as no particular disorder is recited in these claims only a
mechanism of action, namely diseases ‘associated with undesirable integrin
binding’.” The examiner finds (id.) the “claim language is of indeterminate scope
since it may read on diseases that are affected by integrin binding … in ways not
yet understood.”
In response, appellants argue (Reply Brief, page 3) “[w]hile it is possible that
there may be disease conditions caused by undesirable integrin binding which
cannot be treated successfully by the compounds of the invention, the existence of a
few inoperable embodiments does not render the invention non-enabled or of
indeterminate scope.” We agree. Cf. Atlas Powder Co. v. E.I. DuPont De Nemours
& Co., 750 F.2d 1569, 1576-77, 224 USPQ 409, 414 (Fed. Cir. 1984):
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Application No. 08/642,268

Even if some of the claimed combinations were inoperative,
the claims are not necessarily invalid. “It is not a function of the
claims to specifically exclude ... possible inoperative
substances....” In re Dinh-Nguyen, 492 F.2d 856, 859-59, 181
USPQ 46, 48 (CCPA 1974)(emphasis omitted). Accord, In re
Geerdes, 491 F.2d 1260, 1265, 180 USPQ 789, 793 (CCPA
1974); In re Anderson, 471 F.2d 1237, 1242, 176 USPQ 331,
334-35 (CCPA 1971). Of course, if the number of inoperative
combinations becomes significant, and in effect forces one of
ordinary skill in the art to experiment unduly in order to practice
the claimed invention, the claims might indeed be invalid. See
e.g., In re Cook, 439 F.2d 730, 735, 169 USPQ 298, 302
(CCPA 1971).

On this record, the examiner failed to provide evidence demonstrating that the
number of inoperative combinations is significant enough to force one of ordinary
skill in the art to experiment unduly in order to practice the claimed invention.
The examiner also finds (Answer, pages 4-5) “[t]he level of undesirable
integrin binding is not synonymous with doses of specific drugs needed for
administration to treat a specific disease but rather the underlying physiological
contributing factor that may lead to one or more diseases that is present in the host
and this quantity is never defined.” In response appellants argue (Reply Brief, page
3) that “one of skill in the art would known that ‘undesired integrin binding’ is an
amount of binding which results in disease symptoms, e.g., the disease recited in
the specification, so the term is not indefinite.” We agree.
Furthermore, appellants argue (Brief, page 4) that “the ‘effective’ amount of
an agent required to inhibit an integrin is the amount of the agent which, in fact, does
inhibit the interaction of an integrin with its receptor and/or ligand. Since the amount
which provides such activity can be readily determine by one of ordinary skill in the
art, the meaning of ‘effective amount’ is known.” Again, we agree with appellants.
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On reflection, we find that the examiner failed to meet her burden of
establishing that the claims are indefinite. Accordingly, we reverse the examiner’s
rejection of claims 7-11 under 35 U.S.C. § 112, second paragraph.
REVERSED

William F. Smith )
Administrative Patent Judge )
)
)
) BOARD OF PATENT
Donald E. Adams )
Administrative Patent Judge ) APPEALS AND
)
) INTERFERENCES
)
Demetra J. Mills )
Administrative Patent Judge )

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