Ex Parte ENDO et al

Patent Trial and Appeal Board

Jun 27, 2014

12125569 (P.T.A.B. Jun. 27, 2014)

UNITED STATES PATENT AND TRADEMARK OFFICE
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BEFORE THE PATENT TRIAL AND APPEAL BOARD
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Ex parte HIROFUMI ENDO, YOSHIYUKI YONETANI,
HIROSHI MIZOGUCHI, SHIN-ICHI HASHIMOTO, and
AKIO OZAKI,
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Appeal1 2012-009421
Application2 12/125,569
Technology Center 1600
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Before DEMETRA J. MILLS, JEFFREY N. FREDMAN, and
ULRIKE W. JENKS, Administrative Patent Judges.

JENKS, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims directed to a
process of producing a compound using host cells transformed with the
nucleotide sequence set out in SEQ ID NO:2. The Examiner has rejected the
claims as anticipated. We have jurisdiction under 35 U.S.C. § 6(b).
We reverse.

1 The record contains an Oral Hearing Transcript of the hearing held
June 12, 2014.
2 Appellants identify Kyowa Hakko Bio Co., Ltd. as the Real Party in
Interest. (App. Br. 3.)
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Application 12/125,569

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STATEMENT OF THE CASE
Claims 1-12 are on appeal, and are reproduced in the Claims
Appendix of the Appeal Brief.
The Examiner has rejected claims 1-12 under 35 U.S.C. § 102(b) as
anticipated by Endo WO 00/44886.3

The Issue
The Examiner takes the position that the present application is not
entitled to the benefit of priority to Endo ’1114 and ultimately to the
International Application Endo WO 00/44886 because “SEQ ID NO: 2 as
disclosed in the instant application is not [identical to] SEQ ID NO: 2 as
disclosed in U.S. Application No. 09/869,334 [now Endo ’111].” (Ans. 7
(emphasis omitted).) “SEQ ID NO: 2 in U.S. Application No. 09/869,334
[Endo ’111] differs from SEQ ID NO: 2 of the instant application by one
nucleotide at position 462.” (Id.)
The issue with respect to this rejection is whether Appellants have
established that the Examiner erred in (i) determining that the claims are not
entitled to a benefit date of January 29, 1999, and (ii) applying WO
00/44886 as prior art?
Findings of Fact
FF1. The Specification provides a hydroxylase protein, “[a] protein
having the amino acid sequence shown by SEQ ID NO: 1.” (Spec. 9.)

3 Endo et al., WO 00/44886 filed Jan. 28, 2000, which claims benefit to the
Japanese Application 11-21707, filed Jan. 29, 1999.
4 Endo et al., U.S. Application No. 09/869,334, now Patent No.
US 7,049,111.
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Application 12/125,569

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FF2. The Specification provides “[t]he DNA fragment amplified by
PCR with a combination of primers of SEQ ID NO:27 and 28 above,
contained the nucleotide sequence shown by SEQ ID NO:2; and said
nucleotide sequence contained a nucleotide sequence encoding a protein
having the amino acid sequence shown by SEQ ID NO:1.” (Spec. 41.)
Analysis
Appellants contend
[t]he Sequence Listing of the ‘111 patent also discloses the
protein encoded by SEQ ID NO: 2, which protein is designated
SEQ ID NO: l. Appellant submits that SEQ ID NOS: 1 and 2
of the ‘111 patent, and that SEQ ID NOS: 1 and 2 as disclosed
in the “CRF Sequence Listing File” in the Image File Wrapper
of the ‘334 application with mail room date October 4, 2001
both indicate that SEQ ID NO: 2 encodes the protein of SEQ ID
NO: 1. Further, both documents indicate that nucleotides 460-
462 of SEQ ID NO: 2 code for a histidine (His) residue at
position 154 of SEQ ID NO: l. However, incorrect substitution
of a “g” at position 462 would result in a corresponding
glutamine (Gln) residue, not His. Accordingly, one of ordinary
skill in the art would have immediately known that substitution
of a “g” at position 462 of SEQ ID NO: 2 was incorrect in view
of the other disclosure in the ‘111 patent and in view of the
‘334 application papers as filed.
(App. Br. 23; see also Reply Br. 15; see also Oral Hearing Transcript 10.)
Although we find the Examiner’s position is well-reasoned, given the
particular facts presented in the prosecution history of the present
Specification, we find that the totality of the evidence weighs in favor of
Appellants. Specifically, the Specification discloses that SEQ ID NO: 2
encodes the amino acid sequence set out in SEQ ID NO:1 (FF 1 & 2). As
pointed out by Appellants, the substitution of “g” instead of “t” at position
462 of SEQ ID NO:2 would results in a change in the amino acid sequence
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Application 12/125,569

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from the correct amino acid histidine to a glutamine in the amino acid
sequence of SEQ ID NO:1. However, a review of the Specification and all
listed benefit applications, each shows that SEQ ID NO:1 at all times
contained the correct amino acid His at that critical position.
Here, the benefit application resulting in Endo ’111 shows that SEQ
ID NO: 2 as disclosed in the sequence listing associated with Endo ’111
could not encode for SEQ ID NO:1 as described in the Specification. The
nucleotide sequence listened in SEQ ID NO: 2 of Endo ’111 would result in
a change of the amino acid from His to Gln in the associated amino acid
sequence. Appellants contend that SEQ ID NO: 2 was correct in the
sequence listing as originally filed in Endo ’111 (App. Br. 21, see also 23,
25). Indeed, a review of the file wrapper associated with the prosecution
history of Endo ’111 shows that the sequence listing of Oct. 4, 2001,
contains SEQ ID NO:2 with the correct sequence while the sequence
submitted on Dec 28, 2001 contains the typographical error at position 462
changing the “t” to a “g.” Because SEQ ID NO: 2 encodes for the amino
acid of SEQ ID NO:1, we agree with Appellants position that a
typographical error was inadvertently introduced into the record of
Endo ’111.5 Based on the totality of the evidence of this record, we find that

5 We note that during oral argument, Appellants acknowledge that there
were two viable alternatives for correcting the typographical errors in the
sequence in Patent No. US 7,049,111, either by filing a reissue or by filing a
continuation application. Either route would have introduced more
prosecution into the application, and Appellants indicated that due to the
way amendments are introduced in reissue cases “it made a whole lot more
practical sense and expediency to go the more familiar route” of filing a
continuation (Oral Hearing Transcript 6).
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Application 12/125,569

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there is no break in the chain of continuity of the benefit applications; as
such, the present application is entitled to the earliest benefit date. Because
the present application is entitled to the earliest benefit date, Endo
WO 00/4486 is not available as prior art under 35 U.S.C. § 102(b). We
reverse the rejection of claims 1-12 as anticipated by Endo WO 00/44886.

SUMMARY
We reverse the rejection of claims 1-12.

REVERSED

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