Ex Parte Mascarenhas

Board of Patent Appeals and Interferences

Mar 31, 2006

09399120 (B.P.A.I. Mar. 31, 2006)

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for publication and is not binding precedent of the Board.

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte DESMOND MASCARENHAS
__________

Appeal No. 2006-0188
Application No. 09/399,120
__________

ON BRIEF
__________

Before ADAMS, MILLS, and GREEN, Administrative Patent Judges.

GREEN, 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 1-10, 16 and 18-50. Claims 1 and 16 are representative
of the subject matter on appeal, and read as follows:
1. A method for slowing the growth rate of a tumor, comprising: administering
an effective amount of uncomplexed null insulin-like growth factor I (IGF-I) to a
subject having cancer.

16. A method for slowing progression of a cancer comprising: administering
an effective amount of uncomplexed null insulin-like growth factor I (IGF-I) to a
subject having cancer, thereby slowing progression of the cancer.

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Application No. 09/399,120

Claims 1-10, 16, 18-50 stand rejected under 35 U.S.C. §112, first
paragraph, as failing to comply with the enablement requirement. After careful
review of the record and consideration of the issue before us, we reverse.
DISCUSSION
Claim 1 is drawn to “[a] method for slowing the growth rate of a tumor,
comprising: administering an effective amount of uncomplexed null insulin-like
growth factor I (IGF-I) to a subject having cancer.” As defined by the
specification at page 5, a null IGF-I “refers to IGF-I which has amino acid
sequence alterations at one or more sites in the molecule,” and “retains its ability
to bind to IGFBP-3, but is altered in its receptor binding and/or activating
properties (e.g., having little or no binding to the type I IGF receptor while
maintaining its binding activities for the type 2 IGF receptor and the insulin
receptor.)”
Claims 1-10, 16 and 18-50 stand rejected under 35 U.S.C. § 112, first
paragraph, as containing subject matter that was not described in the
specification in such a way as to enable one skilled in the art to which it pertains,
or with which it is most nearly connected, to make and/or use the invention.
Examiner’s Answer, page 4.
The examiner bears the initial burden of showing nonenablement. See In
re Wright, 999 F.2d 1557, 1561-62, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993).
“[E]nablement requires that the specification teach those in the art to make and
use the invention without ‘undue experimentation.’ . . . That some
experimentation may be required is not fatal; the issue is whether the amount of

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Application No. 09/399,120

experimentation required is ‘undue.’” In re Vaeck, 947 F.2d 488, 495, 20
USPQ2d 1438, 1444 (Fed. Cir. 1991) (emphasis in original). Some
experimentation, even a considerable amount, is not “undue” if, e.g., it is merely
routine, or if the specification provides a reasonable amount of guidance as to
the direction in which the experimentation should proceed. See In re Wands,
858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988).
The examiner goes through the Wands factors in rejecting the claims, see
In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1403 (Fed. Cir. 1988),
concluding “that one skilled in the art could not practice the invention without
undue experimentation,” Examiner’s Answer, page 4.
The examiner’s first large concern as to the state of the prior art appears
to be that “[t]he state of the art with respect to animal models indicate that
xenograft mouse models are poor predictors to tumor behavior in humans.” Id. It
is unclear, however, what model would be predictive given the statement that
“the fundamental problem in cancer research is that model systems are not
predictive of in-vivo activity.” Id. at 5.
From these statements, it appears that the examiner is of the opinion that
a cancer therapy is not enabled until it is clinically available to humans. However,
this is not the legal standard to be applied.
As explained in In re Brana, 51 F.3d 1560, 1567, 34 USPQ2d 1436, 1442
(Fed. Cir. 1995), the USPTO should not confuse "the requirements under the law
for obtaining a patent with the requirements for obtaining government approval to
market a particular drug for human consumption," citing Scott v. Finney, 34 F.3d

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Application No. 09/399,120

1058, 1063, 32 USPQ2d 1115, 1120 (Fed. Cir. 1994). The rejection before the
court for review in Brana was under 35 U.S.C. § 112, first paragraph
(enablement). However, the court discussed the issues raised in the appeal in
the context of both enablement and the utility requirement of 35 U.S.C. § 101.
The court went on to state in Brana, 51 F.3d at 1568, 34 USPQ2d at 1442-43:
On the basis of animal studies, and controlled testing in a
limited number of humans (referred to as Phase I testing), the Food
and Drug Administration may authorize Phase II clinical studies.
See 21 U.S.C. § 355(i)(1); 5 C.F.R. § 312.23 (a)(5), (a)(8) (1994).
Authorization for a Phase II study means that the drug may be
administered to a larger number of humans, but still under strictly
supervised conditions. The purpose of a Phase II study is to
determine primarily the safety of the drug when administered to a
larger human population, as well as its potential efficacy under
different dosage regimens. See 21 C.F.R. § 312.21(b). FDA
approval, however, is not a prerequisite for finding a compound
useful within the meaning of the patent laws. . . . . Usefulness in
patent law, and in particular the context of pharmaceutical
inventions, necessarily includes the expectation of further research
and development. The stage at which an invention in this field
becomes useful is well before it is ready to be administered to
humans. Were we to require Phase II testing in order to prove
utility, the associated costs would prevent many companies from
obtaining patent protection on promising new inventions, thereby
eliminating an incentive to pursue, through research and
development, potential cures in many crucial areas such as the
treatment of cancer.

In re Brana, 51 F.3d, 1560, 1568 34 USPQ2d 1436, 1442-43 (Fed. Cir. 1995)
(citations omitted).
The examiner’s second large concern with respect to the state of the art,
as well as the predictability or unpredictability of the art is that “the art has
recognized the difficulty in determining the three dimensional structure of a

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Application No. 09/399,120

peptide based solely on its structure.” Examiner’s Answer, page 5, see also id.
at 6.
This concern appears to based on the determination of other null-IGF-I
proteins, a 70 amino acid long protein, which have amino acid sequence
alterations at one or more sites in the molecule, while retaining their ability to
bind to IGFBP-3, but altered in their receptor binding and/or activating properties.
The examiner’s last concern appears to be that “[a]lthough the
specification provides guidance on how to make the peptides of the claimed
invention, the specification has not provided ample guidance [as to] the
effectiveness of peptides as inhibiting the growth rate of a tumor.” Examiner’s
Answer, page 7. The examiner goes on to state that “[t]he working examples are
limited to a single peptide, Y60L IGF-I, which was shown to be effective against
prostate cancer,” id., and that “the claims are drawn to the treatment of all
cancers,” but “the specification has only shown effectiveness towards a single
type of cancer,” id. at 9.
The rejection concludes:
Since, the is [sic] uncertain to predict the helical structure of
amino acid sequences based on structure alone, since
contemporary hardware falls eight to nine orders of magnitude
short of the task, and since different aspects of biological activity
cannot be predicted a priori but must be determined from the case
to case by painstaking experimental study, one of ordinary skill in
the art would be burdened with undue “painstaking experimentation
study” to determine if the peptides would be effective in slowing the
growth rate of tumors in a subject having cancer.

Id. at 10.

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Application No. 09/399,120

With respect to the unpredictability of predicting function from sequence,
the examiner’s discussion is drawn to proteins in general, and is not directed to
issues that may arise specifically with null IGF-I. Moreover, as noted by
appellants, the specification discusses modifications that may be made to a IGF-I
molecule to result in a null IGF-I See Appeal Brief, page 5. Thus, the
specification teaches at page 5 that:
Examples of null IGF-I include variants in which one or more of
IGF-I’s tyrosine residues (i.e., residues 24, 31, or 60) are replaced
with non-aromatic residues (i.e., other than tyrosine, phenylalanine
or tryptophan), variants where amino acid residues 49, 50, 51, 53,
55 and 56 are altered (for example, where residues 49-50 are
altered to Thr-Ser-Ile or where residues 55-56 are altered to Try-
Gln), and combinations thereof.

The examiner has not provided any evidence or reasoning specific to the
null IGF-I, other than the assertion that it is unpredictable to go from structure to
function, as to why the null IGF-I proteins disclosed in the Specification will not
work in the claimed methods. Moreover, as taught by the specification, a null
IGF-I has amino acid sequence alterations at one or more sites in the molecule,
while retaining its ability to bind to IGFBP-3, but is altered in its receptor binding
and/or activating properties, and the examiner has not addressed why it would
require an undue amount of experimentation by the skilled artisan to make
variants and then test them for the required properties. As noted above, some
experimentation, even a considerable amount, is not “undue” if, e.g., it is merely

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Application No. 09/399,120

routine, or if the specification provides a reasonable amount of guidance as to
the direction in which the experimentation should proceed.
With respect to the examiner’s concern that the claims are drawn to the
treatment of all cancers, but the specification has only shown effectiveness
towards a single type of cancer, again, the examiner has not provided evidence
or reasoning specific to the use of null-IGF-1 in the treatment of cancer why it
would require an undue amount of experimentation to test the null IGF-1 against
different types of cancers using the example provided by the specification,
Example 2, page 11, as a guide.
CONCLUSION
Because the examiner has failed to meet the burden of setting forth a
prima facie case of lack of enablement, the rejection is reversed.
REVERSED

Donald E. Adams )
Administrative Patent Judge )
)
)
) BOARD OF PATENT
Demetra J. Mills )
Administrative Patent Judge ) APPEALS AND
)
) INTERFERENCES
)
Lora M. Green )
Administrative Patent Judge )

Appeal No. 2006-0188 Page 8
Application No. 09/399,120

Ms. Beth Burrous
Foley & Lardner
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