Ex Parte WOLD et al

Board of Patent Appeals and Interferences

Sep 28, 2006

09351778 (B.P.A.I. Sep. 28, 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for publication and is not binding precedent of the Board.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 WILLIAM S. M. WOLD, KAROLY TOTH,
KONSTANTIN DORONIN and ANN E. TOLLEFSON
__________

Appeal No. 2005-1444
Application No. 09/351,778
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ON BRIEF
__________

Before ADAMS, MILLS1 and GREEN, Administrative Patent Judges.

GREEN, Administrative Patent Judge.

REQUEST FOR REHEARING
Appellants request reconsideration (rehearing) of the Board's Decision
entered January 24, 2006, (Decision), wherein the examiner's rejections of the
appealed claims under 35 U.S.C. § 112, first paragraph, § 102 and § 103 were
affirmed.2

1 The merits panel that issued the initial opinion in this case included Administrative Patent Judge
Ellis, who retired from the U.S. Patent and Trademark Office before Appellants filed their Request for
Rehearing. Administrative Patent Judge Mills has replaced Administrative Patent Judge Ellis on this
merits panel. See In re Bose Corp., 772 F.2d 866, 227 USPQ 1 (Fed. Cir. 1985).
2 Also before the panel for review was a rejection under 35 U.S.C. § 112, second paragraph, which
rejection was affirmed. See Decision, pages 9-11. Appellants, however, do not request rehearing on
that issue.

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Application No. 09/351,778
In their Request for Rehearing (Request), appellants make a series of
assertions. We take each in turn.
I. The rejection of claims 32 and 104-106 under 35 U.S.C. § 112, first paragraph,
should be reversed:
Appellants assert that the specification demonstrates the usefulness of cell
lysis, virus release, and inhibition of cell spreading in assessing ADP
overexpression. See Request, pages 15-16. As to cell lysis, appellants point to
Example 2 of the specification as demonstrating the usefulness of cell lysis to
assess ADP overexpression, and that in fact, “cell lysis assays were specifically
used to confirm ADP overexpression in the claimed adenoviruses.” Id. at 15
(emphasis in original). Appellants also point to page 25 of the specification as
demonstrating that virus release assays were assessed as “‘another means to
measure cell lysis and to examine virus replication in cancer cells.’” Id. (emphasis in
original). Finally, as to inhibition of cell spreading, appellants point to page 26 of the
specification as demonstrating that virus release may be used to assess ADP
overexpression. See id. at 16.
Upon reconsideration, we agree with appellants in this regard, and the
rejection of claims 32 and 104-106 under 35 U.S.C. § 112, first paragraph, as
containing new matter, is reversed.
II. The Board failed to establish a proper basis for its “Inherency” rejection:
Appellants argue that the only evidence relied upon by the Board, in affirming
the rejections under § 102(b), “was the alleged similarity of methods by which the
respective adenoviruses were made,” but that the Board “apparently failed to

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Application No. 09/351,778
consider the evidence on the face of Henderson/Little . . . that demonstrated that
their construct did not overexpress ADP.” Request, page 4. According to
appellants, “”inherency rejections are only proper where there is certainty with
regard to the subject matter of the reference,” and “comments such as ‘absent
evidence to the contrary’ and ‘would expect’ evince a misapplication of the inherency
doctrine, and an attempted shifting of burdens without a sufficient evidentiary basis.”
See id.
In the request, appellants reiterate their arguments made in the Appeal Brief
that both Henderson and Little teach that CN751 expresses about the same amount
of ADP as does wild-type adenovirus, and thus cannot be said to overexpress ADP.
Therefore, as the claims require overexpression relative to dl309, and as dl309
according to appellants expresses “wild-type” levels of ADP, appellants submit that
there is no reason, either explicit or inherent, to read Henderson or Little as
providing ADP overexpression as required by the rejected claims. See id. at 5.
Appellants appear to have misapprehended the reasoning of the Board in
affirming the § 102(e) rejections over Henderson and Little. As noted in the Decision
at page 14, claim 13 recites that the “adenovirus vector . . . overexpresses an
adenovirus death protein wherein in overexpression is defined as overexpression
relative to dl309.” The claim does not require a particular level of overexpression
over that of dl309, thus all that is required by claim 13 is any measurable level of
ADP expression over that of dl309. Thus, the panel read the claim as requiring
overexpression of ADP, but construed the claim as requiring any level of
overexpression, such as a 1% increase, over that of dl309.

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Application No. 09/351,778
As also set forth in the decision, there is enough evidence on the record
demonstrating that such a level of overexpression would be inherent in the
recombinant adenoviruses expressing ADP taught by Henderson and Little, thus the
burden has been properly shifted to appellants to demonstrate that the adenoviruses
of Little and Henderson do not meet that limitation. See In re Best, 562 F.2d 1252,
1255, 195 USPQ 430, 433 (CCPA 1977) (noting that the PTO can require an
applicant to establish that a prior art product does not necessarily possess the
characteristics of the claimed product when the prior art products and claimed
products are identical or substantially identical). Appellants prepare the
adenoviruses required by the method of claim 13 by deleting the E3 region, and
inserting the ADP gene from Ad5. See Specification, Example 1, page 20-21.
Similarly, Henderson and Little also deleted the E3 region, and then inserted the
ADP gene from Ad2. See Henderson, Col. 48, Example 6, lines 15-33; Little, Col.
38, Example 5, lines 20-25. As the adenoviruses taught by the Henderson and Little
and those taught by the instant specification were constructed in an analogous
manner, i.e., deletion of the E3 region followed by introduction of an ADP coding
region, absent evidence to the contrary, one of ordinary skill in the art would expect
the recombinant adenoviruses of Henderson and Little to express comparable
amounts of ADP as the recombinant adenoviruses taught by the instant
specification.
We note that in the Request, appellants have not addressed Best, nor the
discussion of the evidence on the record that the adenoviruses taught by the
Henderson and Little and those taught by the instant specification were constructed

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Application No. 09/351,778
in an analogous manner. See Decision, page 14. Appellants only response is that
the only evidence relied upon by the Board is “the alleged similarity of methods by
which the respective adenoviruses were made,” but the record contains no evidence
that contradicts the reasoning of the Board except appellants assertion that that both
Henderson and Little teach that CN751 expresses about the same amount of ADP
as does wild-type adenovirus, and thus cannot be said to overexpress ADP. But, as
the comparison in Little and Henderson are to a wild type virus and not to dl309 as
required by the instant claims;3 as the adenoviruses taught by the Henderson and
Little and those taught by the instant specification were constructed in an analogous
manner; as the claims read on any level of overexpression as compared to dl309;
and as the PTO does not have the resources to determine if the adenoviruses
constructed by Henderson and Little meet the limitations of claim 13, the burden was
properly shifted to appellants to demonstrate the adenoviruses as taught by
Henderson and Little are different from the adenoviruses required by the method of
claim 13.4
Accordingly, we are not persuaded by appellants’ argument.
III. The Board failed to conduct a proper analysis to determine whether the patents
cited as art under § 102(e) claim the same subject matter as the instant application:
Because we have reaffirmed our finding that the claims on appeal are
anticipated § 102(e) by Henderson and Little, the issue becomes, as argued by

3 We also point appellants’ attention to the discussion on page 15 of the Decision that appellants’
arguments in this regard are premised on the assumption that “cell killing is directly and always
correlated to ADP overexpression,” which discussion was not addressed by appellants in the
Request.
4 We note that the first full paragraph of the Decision on page 13 refers to claims 11-12, 32-44, 101-
106 and 108. The reference should have been to claims 11-13, 32-44, 101-106 and 108.

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Application No. 09/351,778
appellants, that in order to demonstrate that the claims on appeal conflict with the
Henderson/Little claims, a two-way analysis of patentable distinction must be
performed, and that no such analysis was provided by the Board. See Request,
pages 6-7. Appellants argue, at most, the Board has merely established one-way
anticipation. Thus, appellants conclude, the Board erred in failing to consider the
Rule 131 declarations submitted to remove Henderson and Little as prior art. See
id. at 7.
A 37 CFR § 1.131 affidavit is ineffective to overcome a United
States patent or patent application publication, not only where there is
a verbatim correspondence between claims of the application and of
the patent, but also where there is no patentable distinction between
the respective claims. In re Clark, 457 F.2d 1004, 173 USPQ 359
(CCPA 1972); In re Hidy, 303 F.2d 954, 133 USPQ 650 (CCPA 1962);
In reTeague, 254 F.2d 145, 117 USPQ 284 (CCPA 1958); In re Ward,
236 F.2d 428,111 USPQ 101 (CCPA 1956); In re Wagenhorst, 62 F.2d
831, 16 USPQ 126(CCPA 1933).

MPEP § 715.05.
Thus, while a Rule 131 declaration may be used to antedate a reference that
is prior art under 35 U.S.C. § 102(e), the panel notes, as explained above, that such
a declaration is ineffective if there is no patentable distinction between the claims of
the application and the claims of the patent being applied as prior art under 35
U.S.C. § 102(e), and in such a case, appellants only recourse is through interference
proceedings. As provided in 37 CFR § 41.203(a), an interference exists if the
subject matter of a claim of one party would, if prior art, have anticipated

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Application No. 09/351,778
or rendered obvious the subject matter of a claim of the opposing party and
vice versa. We agree with appellants that in order to determine if an interference
exists, it must be determined if the instant claims anticipate or render obvious claims
of the Henderson/Little patents, and if claims of the Henderson/Little patents
anticipate or render obvious the claims on appeal.
As that analysis has not been made in the first instance, and as the board
serves as a board of review, not a de novo examination tribunal, see 35 U.S.C.
§ 6(b) (“The [board] shall, on written appeal of an applicant, review adverse
decisions of examiners upon applications for patents.”), we remand the case to the
examiner to perform that analysis. In performing that analysis, the examiner may
wish to consult with the interference specialist in the technical center. If the
examiner determines that the two-way test has not been met, the examiner should
state the reasons therefore on the record and return the case to the Board for
consideration of the Rule 131 declarations.
FUTURE PROCEEDINGS
This remand to the examiner pursuant to 37 CFR § 41.50(a)(1) (effective
September 13, 2004, 69 Fed. Reg. 49960 (August 12, 2004), 1286 Off. Gaz. Pat.
Office 21 (September 7, 2004)) is made for further consideration of a rejection.
Accordingly, 37 CFR § 41.50(a)(2) applies if a supplemental examiner's answer is
written in response to this remand by the Board.

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Application No. 09/351,778
This application, by virtue of its “special” status, requires an immediate action.
MPEP § 708.01(D) (8th ed., rev. 3, August 2005). It is important that the Board be
informed promptly of any action affecting the appeal in this case.
REQUEST FOR REHEARING GRANTED-IN-PART; REMANDED

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

DEA/jlb

Appeal No. 2005-1444 Page 9
Application No. 09/351,778
STEVEN L. HIGHLANDER
FULBRIGHT & JAWORSKI L.L.P.
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SUITE 2400
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