Ex Parte Holmes et al

Board of Patent Appeals and Interferences

Sep 26, 2002

08824513 (B.P.A.I. Sep. 26, 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for publication and is not binding precedent of the Board.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. 21
UNITED STATES PATENT AND TRADEMARK OFFICE
__________
BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
___________
Ex parte TODD HOLMES,
SHUGUANG ZHANG,
ALEXANDER RICH,
C. MICHAEL DIPERSIO, and
CURTIS LOCKSHIN
___________
Appeal No. 2001-0636
Application No. 08/824,513
__________
ON BRIEF
__________
Before WILLIAM F. SMITH, ADAMS, and MILLS, Administrative Patent Judges.
WILLIAM F. SMITH, Administrative Patent Judge.
DECISION ON APPEAL
This is a decision on appeal under 35 U.S.C. § 134 from the final rejection of
claims 38 through 53, all the claims in the case. Claim 38 is representative of the
subject matter on appeal and reads below:
38. A method for in vitro cell culture comprising:
a) adding a macroscopic membrane which is formed by self-assembly of
amphiphilic peptides in an aqueous solution containing monovalent metal
cations, wherein the peptides have alternating hydrophobic and hydrophilic
amino acids and are complementary and structurally compatible, to a cell culture
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Application No. 08/824,513
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medium comprising cells, thereby forming a membrane/culture mixture; and
b) maintaining the mixture under conditions sufficient for cell growth.
Claims 38 through 53 stand rejected under 35 U.S.C. § 112, first paragraph
(enablement).
The examiner does not rely upon any evidence in support of this rejection. We reverse.
Discussion
Parent Application 08/293,284 has now issued as U.S. Patent No. 5,955,343
('343 patent). The enablement issue raised by the examiner can be put in perspective
in comparing claim 38 of this application reproduced above with claim 1 of the '343
patent which reads as follows:
1. A method for in vitro cell culture comprising:
a) adding a macroscopic membrane which is formed by self-assembly of
amphiphilic peptides in an aqueous solution containing monovalent metal
cations, wherein the peptides are 12 or more amino acids in length, have
alternating hydrophobic and hydrophilic amino acids, and are complementary
and structurally compatible, to a cell culture medium comprising cells, thereby
forming a membrane/culture mixture;
b) maintaining the mixture under conditions sufficient for cell growth.
As seen, claim 1 of the '343 patent is the same as claim 38 on appeal with one
important difference. Claim 1 of the '343 patent further limits the amphiphilic peptides
which form the macroscopic membrane to those which have twelve or more amino
acids in length. Claim 38 on appeal places no limitation on the length of the amphiphilic
peptides. The issue raised by the examiner in the present enablement rejection is
whether one skilled in the art would be able to make and use macroscopic membranes
from amphiphilic peptides having the three stated requirements of claim 38, i.e.,
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Application No. 08/824,513
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1 Hereinafter, these three properties will be referred to as “alternating,
complementary and structural.”
alternating hydrophobic and hydrophilic amino acids, complementary and structurally
compatible1, wherein the peptides are less than 12 amino acids in length.
In stating the rejection on pages 3-4 of the Examiner's Answer, the examiner
emphasizes one fact, i.e., the vast majority of the original disclosure of this application
describes the present invention in terms of the amphiphilic peptides being of 12 or more
amino acids in length. However, that is not to say the original disclosure of this
application fails to describes amphiphilic peptides which have the “alternating,
complementary and structural” requirements but contain fewer than 12 amino acids in
length. For example, original claim 1 of this application was directed to a method for in
vitro cell culture as is present claim 38, but placed no length restriction on the
amphiphilic peptides which form the macroscopic membranes.
In this regard, we note that the examiner has not rejected the claims on appeal
under the written description requirement of 35 U.S.C. § 112, first paragraph. Given
that appellants have described an invention broader than claim 1 of the '343 patent, the
issue becomes whether one skilled in the art would be able to make and use the
claimed invention to the extent it reads upon amphiphilic peptides having the
“alternating, complementary, structural” properties but contain fewer than 12 amino
acids.
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Application No. 08/824,513
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Viewed in this light, the issue raised by the examiner is one of undue
experimentation. In considering the examiner's concern in this regard, we find the
following passage from PPG Indus., Inc. v. Guardian Indus. Corp., 75 F.3d 1558, 1564,
37 USPQ2d 1618, 1623 (Fed. Cir. 1996) instructive:
In unpredictable art areas, this court has refused to find broad generic
claims enabled by specifications that demonstrate the enablement of only
one or a few embodiments and do not demonstrate with reasonable
specificity how to make and use other potential embodiments across the
full scope of the claim. See, e.g., In re Goodman, 11 F.3d 1046, 1050-52,
29 USPQ2d 2010, 2013-15 (Fed. Cir. 1993); Amgen, Inc. v. Chugai
Pharmaceutical Co., 927 F.2d. 1200, 1212-14, 18 USPQ2d 1016, 1026-
28 (Fed. Cir.), cert. denied, 502 U.S. 856 (1991); In re Vaeck, 947 F.2d at
496, 20 USPQ2d at 1445. Enablement is lacking in those cases, the
court has explained, because the undescribed embodiments cannot be
made, based on the disclosure in the specification, without undue
experimentation. But the question of undue experimentation is a matter of
degree. The fact that some experimentation is necessary does not
preclude enablement; what is required is that the amount of
experimentation “must not be unduly extensive.” Atlas Powder Co., v. E.I.
DuPont De Nemours & Co., 750 F.2d 1569, 1576, 224 USPQ 409, 413
(Fed. Cir. 1984). The Patent and Trademark Office Board of Appeals
summarized the point well when it stated:
The test is not merely quantitative, since a considerable
amount of experimentation is permissible, if it is merely
routine, or if the specification in question provides a
reasonable amount of guidance with respect to the direction
in which the experimentation should proceed to enable the
determination of how to practice a desired embodiment of
the invention claimed.
Ex parte Jackson, 217 USPQ 804, 807 (1982).
The only specific finding made by the examiner which is relevant in considering this
legal standard is found at page 8 of the Examiner's Answer where the examiner states
"without specific guidance on which 9, 10 and 11 amino acid sequences to use for the
peptide membrane forming experiments, a very large amount of peptide sequences
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would have to be screened." As seen, the examiner focuses on the amount
of experimentation which may be required instead of explaining why that
experimentation would be undue and not routine. Absent a fact-based explanation from
the examiner as to why the experimentation needed to make and use the claim
embodiments where amphiphilic peptides are needed having the “alternating,
complementary and structural” properties but contain fewer than 12 amino acids, we
hold that the examiner has failed to establish a prima facie case of lack of enablement.
To the extent the examiner is concerned that the claims may embrace possibly
inoperative embodiments, we point to Atlas Powder Co. v. E.I. du Pont de Nemours &
Co., 750 F.2d 1569, 1576-77, 224 USPQ 409, 414 (Fed. Cir. 1984), where the court
stated:
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, 858-59, 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 1973). 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).
Again, absent a fact-based explanation from the examiner why the number of
possible inoperative embodiments is significant, we do not find that the examiner has
established a prima facie case of lack of enablement.
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routine, we hold that the examiner has failed to properly establish a prima facie case of
non-enablement.
The decision of the examiner is reversed.
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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Application No. 08/824,513
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Brenda H. Jarrell, Esq.
Choate, Hall & Stewart
Exchange Place
53 State Street
Boston, MA 02109-2804
dem