Ex Parte Mizuguchi et al

Patent Trial and Appeal Board

May 17, 2016

10516504 (P.T.A.B. May. 17, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
10/516,504 12/02/2004 Hiroyuki Mizuguchi
22428 7590 05/19/2016
Foley & Lardner LLP
3000 K STREET N.W.
SUITE 600
WASHINGTON, DC 20007-5109
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www .uspto.gov
ATTORNEY DOCKET NO. CONFIRMATION NO.
081356-0226 8630
EXAMINER
MARVICH, MARIA
ART UNIT PAPER NUMBER
1633
NOTIFICATION DATE DELIVERY MODE
05/19/2016 ELECTRONIC
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address( es):
ipdocketing@foley.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte HIROYUKI MIZUGUCHI,
TAKAO HAY AKA WA, and FUMINORI SAKURAI
Appeal2013-010766
Application 10/516,504
Technology Center 1600
Before DONALD E. ADAMS, JEFFREY N. FREDMAN, and
RICHARD J. SMITH, Administrative Patent Judges.
FREDMAN, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal 1 under 35 U.S.C. § 134 involving claims to an
adenovirus type 35 vector. The Examiner rejected the claims as obvious.
We have jurisdiction under 35 U.S.C. § 6(b ). We reverse.
1 Appellants identify the Real Party in Interest as Fuso
Pharmaceutical Industries LTD, Hiroyuki Mizuguchi,
Takao Hayakawa and Fuminori Sakurai (see Br. 4).
Appeal2013-010766
Application 10/516,504
Statement of the Case
Background
"51 or more types of adenovirus serotypes that are infected with
humans as a host have been discovered, and adenovirus type 2 and type 5 are
used as vectors for gene therapy" (Spec 1 ).
The Claims
Claims 1, 7, and 19-21 are on appeal. Independent claim 1 is
representative and reads as follows:
1. An adenovirus type 35 vector, comprising an adenovirus
type 35 genome from which there are deleted (A) a segment of
the El region, wherein the segment consists of nucleotides 367
to 2,917 and (B) a segment of the E3 region, wherein the
segment consists of nucleotides 27,760 to 29,732.
The Issues
A. The Examiner rejected claims 1, 7, and 19 under 35 U.S.C. § 103(a)
over Vogels '801 2 and Vogels '169 3 (Ans. 5-7).
B. The Examiner rejected claims 1, 7, and 19-21under35 U.S.C.
§ 103(a) overVogels '801, Vogels '169, and Wadell4 (Ans. 8)
A. 35 US.C. § 103(a) over Vogels '801 and Vogels '169
The Examiner finds that Vo gels '801 teaches "construction of E 1, E3
deleted Ad3 5 vectors wherein the E 1 deletion is from nucleotides 464 to
3401 and E3 deletion between nucleotides 27 ,648 and 30,320" (Ans. 5).
The issue with respect to this rejection is: Does the evidence of record
2 Vogels et al., US 2003/0185801 Al, published Oct. 2, 2003.
3 Vogels et al., US 6,492,169 Bl, issued Dec. 10, 2002.
4 Wadell et al., US 2004/0136958 Al, published July 15, 2004.
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Application 10/516,504
support the Examiner's conclusion that Vogels '801 and Vogels '169 render
claim 1 obvious?
Findings of Fact
1. Vogels '801 teaches "[c]onstruction of Ad35-El Expression
Plasmids" where "the Ad35-El region from bp 468 to bp 3400 was
amplified from wt Ad35 DNA" (Vogels '801 i-fi-f 128, 130).
2. Vogels '801 teaches that the "E3 deletion extends from nucl.
27648 to 30320 of the Ad3S sequence (example 3) and thus spans a 2.6 kb
region" (Vogels '801 i1229).
3. Vo gels '169 teaches that the "Ad3 5 sequences between nucl.
453 and 2804 are deleted thus 596 nucl. of the 3' end ofElb-55K are
retained" (Vo gels '169, col. 21, 1. 66 to col. 22, 1. 1 ).
4. Vogels '169 teaches that "preferably, the Ad35-El sequences
comprise nucleotide 468 to nucleotide 3400 of the Ad35 wt sequence"
(Vo gels '169, col. 3, 11. 14--16).
Principles of Law
A prima facie case for obviousness "requires a suggestion of all
limitations in a claim," CFMT, Inc. v. Yieldup Int'! Corp., 349 F.3d 1333,
1342 (Fed. Cir. 2003) and "a reason that would have prompted a person of
ordinary skill in the relevant field to combine the elements in the way the
claimed new invention does" KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398,
418 (2007).
Analysis
Appellants contend that "the asserted combination fails to evidence a
teaching or suggestion of the specifically prescribed deletion in the E 1
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Appeal2013-010766
Application 10/516,504
region, i.e., 'nucleotides 367 to 2,917.' No permutation of disclosures
reasonably drawn from the references implicates the recited deletion in the
E3 region, i.e., 'nucleotides 27,760 to 29,732."' (Br. 7).
The Examiner responds that "cloning is straightforward and is the
result of a limited number of possible restriction sites and hence the vector
does not require skill beyond common knowledge but is based upon routine
experimentation" (Ans. 14). The Examiner responds that "the deletions
differs by about 100 nucleotide on the 5' end and 500 on the 3' end. These
are minor differences wherein the products achieve the same goal" (Ans.
15-16).
We find that Appellants have the better position. We agree with the
Examiner that Vogels '801 teaching of an E3 deletion from positions 27648
to 30320, fully encompassing the deletion required by claim 1, reasonably
anticipates (and renders obvious) a claim to a vector comprising a deletion
from positions 27,760 to 29,732 because the E3 deletion ofVogels '801
fully encompasses the deletion required by claim 1. The use of the open
"comprising" language allow the vector to encompass deletions larger than
the region specifically recited.
However, neither Vogels '801 nor Vogels '169 teach deletion of the
region from position 367 to positions 453 or 468 of Adenovirus type 35 for
removal of El A. The Examiner has provided no evidence establishing that
ElA deletions from 367 to 453 were known, nor does the Examiner identify
any specific restriction site at position 367 consistent with the reasoning of a
"limited number of possible restriction sites" (Ans. 14 ).
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Application 10/516,504
Instead, the Examiner treats this claim limitation as a "minor
difference" without specifically addressing why cleavage at position 367 or
earlier represents an obvious equivalent or demonstrating any reason or
evidence to include the region between positions 367 and 453 or 468 in the
deletion of El A. In the absence of evidence from the Examiner, we are
constrained to reverse this rejection.
Conclusions of Law
The evidence of record does not support the Examiner's conclusion
that Vogels '801 and Vogels '169 render claim 1 obvious.
B. 35 US.C. § 103(a) over Vogels '801, Vogels '169, and Wadell
This rejection relies upon the underlying obviousness rejection over
Vogels '801 and Vogels '169. Having reversed that rejection, we also
necessarily reverse the further obviousness rejection including Wadell
because Wadell is not relied upon to teach cleavage of the entire El A region
required by claim 1.
SUMMARY
In summary, we reverse the rejection of claims 1, 7, and 19 under 3 5
U.S.C. § 103(a) overVogels '801 and Vogels '169.
We reverse the rejection of claims 1, 7, and 19--21under35 U.S.C.
§ 103(a) overVogels '801, Vogels '169, and Wadell.
REVERSED
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