Ex Parte Nezu et al

Board of Patent Appeals and Interferences

Apr 9, 2010

10762154 (B.P.A.I. Apr. 9, 2010)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte JUN-ICHI NEZU and ASUKA OKU
__________

Appeal 2009-010405
Application 10/762,154
Technology Center 1600
__________

Decided: April 9, 2010
__________

Before ERIC GRIMES, JEFFREY N. FREDMAN, and STEPHEN
WALSH, Administrative Patent Judges.

WALSH, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to an
isolated nucleic acid, a vector, a host cell and a method of producing a
polypeptide. The Patent Examiner rejected the claims for lack of utility and
enablement. We have jurisdiction under 35 U.S.C. § 6(b). We reverse.
Appeal 2009-010405
Application 10/762,154

2
STATEMENT OF THE CASE
The invention is said to relate to transporters, i.e., “proteins involved
in transport of substances from the outside to the inside of cells or vice
versa.” (Spec. 1:9-11.) The Specification states that “[t]he inventors
discovered an unknown gene showing a significant homology with those for
organic cation transporters, OCT1 and OCT2.” (Id. at 4:27-29.) The
Specification is said to disclose “novel transporter genes, proteins encoded
by these genes, and their use” (id. at 5:9-10), and it designates certain novel
transporters as “human OCTN1,” “human OCTN2,” (id. at 6:6-9), “mouse
OCTN1” and “mouse OCTN2” (id. at 6:24-28).
Claims 8, 10, 11, 13, 16, 18-21, 23-25, 27, 32 and 36 are on appeal.1
Claim 8 is representative and reads as follows:
8. An isolated nucleic acid encoding a polypeptide comprising the
sequence of SEQ ID NO:1.

The Examiner rejected the claims under 35 U.S.C. § 101 “because the
claimed invention is not supported by either a credible, specific and
substantial asserted utility or a well established utility” (Ans. 3). The
Examiner also rejected the claims under 35 U.S.C. § 112, first paragraph,
concluding that “[because] the claimed invention is not supported by either a
specific and substantial asserted utility or a well established utility . . . one
skilled in the art clearly would not know how to use the claimed invention”
(id. at 7).

1 Claims 1-7, 9, 12, 14, 15, 17, 22, 26 and 28-31 were canceled, and claims
33-35 were withdrawn. (App. Br. 1.)
Appeal 2009-010405
Application 10/762,154

3
UTILITY
The Issue
The Examiner’s position is that the Specification does not teach “any
physiological significance or functional characteristics of the OCTN1
polynucleotide . . . or polypeptide.” (Ans. 4.) “Without any information as
to the specific properties of OCTN1, the mere identification of the
polypeptide is not sufficient to impart any particular utility to the claimed
polynucleotides.” (Id. at 5.)
Appellants contend that the Specification disclosed using OCTN1 in
screens for carcinostatic compounds transported by the protein. (App. Br.
5.) According to Appellants, “carcinostatic compounds that are identified in
a screen with hOCTN1 transporter protein have the specific and substantial
use of being carcinostatic compounds.” (Id.) Appellants further point out
that examples in the Specification demonstrated that the screening works.
(Id. at 9.)
The issue with respect to this rejection is whether the evidence
supports finding that screening for carcinostatic compounds that can be
transported by OCTN1 is not a specific and substantial utility.

Findings of Fact
1. The Specification states that the results of testing described in the
Specification “revealed that human OCTN1 has the activity to
transport actinomycin D, etoposide, vinblastine, and daunomycin,”
which are said to have been used as carcinostatics. (Spec. 31:5-12.)
2. The Specification states that “[b]y designing and screening drugs
utilizing the substrate specificity of OCTN1 so as to be readily
Appeal 2009-010405
Application 10/762,154

4
recognized by this transporter, it would be possible to efficiently
develop useful drugs that can be readily absorbed by the cells.” (Id. at
31:12-16.)

Principles of Law
[A]n application must show that an invention is useful to the
public as disclosed in its current form, not that it may prove
useful at some future date after further research. Simply put, to
satisfy the “substantial” utility requirement, an asserted use
must show that that claimed invention has a significant and
presently available benefit to the public. . . . in addition to
providing a “substantial” utility, an asserted use must also show
that the claimed invention can be used to provide a well-defined
and particular benefit to the public.

In re Fisher, 421 F.3d 1365, 1371 (Fed. Cir. 2005).
“It is well established that the enablement requirement of § 112
incorporates the utility requirement of § 101.” Fisher, 421 F. 3d at 1378.

Analysis
The evidence contradicts the Examiner’s finding that the Specification
merely identified OCTN1, without disclosing a biological function. Instead,
the Specification demonstrated that OCTN1 works as a transport protein for
carcinostatic drugs. (FF1.)
The Specification stated that OCTN1’s substrate specificity could be
exploited to develop useful drugs that can be readily absorbed by cells.
(FF2.) The Examiner found this utility was not specific or substantial
because “[s]uch assays can be performed with any polypeptide and nucleic
acid.” (Ans. 6.) There is no evidence that any random polypeptide can be
Appeal 2009-010405
Application 10/762,154

5
used in the specific assays that OCTN1 can be used for, and we agree with
Appellants that the Examiner is simply wrong on that point. See App. Br. at
7. There is also no evidence that those in this art regard transporter
screening assays as insubstantial uses, lacking in practical application. The
scientific literature that Appellants cite supports the opposite proposition.
See App. Br. at 11.
For the reasons given in Appellants’ Brief, we agree that the evidence
does not support the utility rejection. As the enablement rejection relied
only on the utility rejection, we reverse it as well.

CONCLUSION
The evidence of record does not support finding that screening for
carcinostatic compounds that can be transported by OCTN1 is not a specific
and substantial utility.

SUMMARY
We reverse the rejection of Claims 8, 10, 11, 13, 16, 18-21, 23-25, 27,
32 and 36 under 35 U.S.C. § 101 for lack of utility; and we reverse the
rejection of the same claims under 35 U.S.C. § 112, first paragraph, for lack
of enablement.

REVERSED

clj

Appeal 2009-010405
Application 10/762,154

6

FISH & RICHARDSON PC
P.O. BOX 1022
MINNEAPOLIS, MN 55440-1022