Ex Parte Zabe et al

Patent Trial and Appeal Board

Jun 27, 2016

11600989 (P.T.A.B. Jun. 27, 2016)

United States Patent and Trademark Office
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
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
11/600,989 11/17/2006 Nancy A. Zabe 64452(49991) 5256
21874 7590
Locke Lord LLP
P.O. BOX 55874
BOSTON, MA 02205
06/29/2016 EXAMINER
YAKOVLEVA, GALINA M
ART UNIT PAPER NUMBER
1678
NOTIFICATION DATE DELIVERY MODE
06/29/2016 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):
patent@lockelord.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte NANCY A. ZABE and CHRISTOPHER J. BASKER1
Appeal 2014-005626
Application 11/600,989
Technology Center 1600
Before ULRIKE W. JENKS, JOHN G. NEW, and RICHARD J. SMITH,
Administrative Patent Judges.
SMITH, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a multi­
analyte column and method of analyzing a single liquid sample. We have
jurisdiction under 35 U.S.C. § 6(b).
We affirm.
1 According to Appellants, the real party in interest is Waters Technologies
Corporation. (Br. 2.)
Appeal 2014-005626
Application 11/600,989
STATEMENT OF THE CASE
Claims on Appeal
Claims 1—16, 18, 19, and 21—23 are on appeal.2 (Appendix A, Br. 13—
16.) Independent claims 1 and 22 are illustrative and read as follows
(emphasis added):
1. A multi-analyte column comprising at least one unit of resin having
ochratoxin specific affinity and, for each unit of resin having ochratoxin
specific affinity, the column further contains about 0.95 to 1.05 units of resin
containing antibody having specificity for zearalenone, about 1.9 to
2.1 units of resin containing antibody having specificity for aflatoxin, and
about 2.8 to 3.2 units of resin containing antibody having specificity for
fumonisin, one unit of resin is the quantity of resin containing antibody that
will bind 50 ng of aflatoxin, 3300 ng of fumonisin, 50 ng of ochratoxin or
1140 ng of zearalenone, respectively, while being substantially free of resin
containing antibody that will bind to deoxynivalenol (DON).
(Id. at 13.)
22. A multi-analyte column comprising at least one unit of resin
having ochratoxin specific affinity and, for each unit of resin having
ochratoxin specific affinity, wherein the column consists essentially of
about 0.95 to 1.05 units of resin containing antibody having specificity for
zearalenone, about 1.9 to 2.1 units of resin containing antibody having
specificity for aflatoxin, and about 2.8 to 3.2 units of resin containing
antibody having specificity for fumonisin, one unit of resin is the quantity
of resin containing antibody that will bind 50 ng of aflatoxin, 3300 ng of
fumonisin, 50 ng of ochratoxin or 1140 ng of zearalenone, respectively.
(Id. at 16.)
Examiner’s Rejections
1. Claims 1—16, 18, 19, and 21—23 stand rejected under 35 U.S.C. § 112,
2 Claims 17 and 20 are withdrawn (Br. 3) but Appendix A identifies claim
21 (rather than claim 20) as withdrawn. (See Br. 16.)
2
Appeal 2014-005626
Application 11/600,989
first paragraph, as failing to comply with the written description
requirement. (Final Act. 5—7.)3
2. Claims 1—16, 18, 19, and 21—23 stand rejected under 35 U.S.C. § 112,
second paragraph, as indefinite. {Id. at 7.)
3. Claims 1—16, 18, 19, and 21—23 stand rejected under 35 U.S.C.
§ 102(b) as anticipated by Ofitserova-5,4 as evidenced by the Declaration of
Dr. Stephen P. Powers.5 {Id. at 7—10.)
4. Claims 1—16,18,19, and21—23 stand rejected under 35 U.S.C. § 103(a)
as unpatentable over Ofitserova-5, as evidenced by the Powers Declaration,
and Scott.6 7{Id. at 11—16.)
5. Claim 19 stands rejected under 35 U.S.C. § 103(a) as unpatentable
over Ofitserova-5, as evidenced by the Powers Declaration, in view of Scott
and Phillips. {Id. at 16—17.)
6. Claims 1—16, 18, 19, and 21—23 stand rejected, under the judicially
created doctrine of obviousness-type double patenting, as unpatentable over
claims 1—19 ofU.S. Patent No. 8,198,0327 {Id. at 17—18.)
3 Office Action dated Jan. 28, 2013.
4 Ofitserova et al., Single Run Analysis of Deoxynivalenol, Aflatoxins,
Ochratoxin A, Zearalenone and Fumonisin by HPLC and Post-column
Derivatization, Pickering Laboratories Method Abstracts, 2004, published at
http://www.ingenieriaanalitica.eom/LloclAl/PDF/PICKERING/7multiresi.p
df (Aug. 18, 2004) (“Ofitserova-5”).
5 Declaration of Dr. Stephen P. Powers pursuant to 37 CFR 1.132, dated
Mar. 14, 2011 (“Powers Declaration”).
6 Scott et al., Application of Immunoaffinity Columns to Mycotoxin Analysis,
80 J. AO AC Int. 5, 941^19 (1997).
7 Zabe et al., US 8,198,032 B2, issued June 12, 2012 (“the ’032 patent”).
3
Appeal 2014-005626
Application 11/600,989
DISCUSSION
Issues—Section 112
Whether a preponderance of evidence of record supports the
Examiner’s conclusion that claims 1—16, 18, 19, and 21—23 fail to satisfy the
written description requirement of 35 U.S.C. § 112, first paragraph, or are
indefinite under 35 U.S.C. § 112, second paragraph.
Analysis
Rejection No. 1
The Examiner found that independent claims 1 and 12 were amended
to include the phrase “while being substantially free of resin containing
antibody that will bind to deoxynivalenol (DON).”8 (Final Act. 5.) The
Examiner found that claims 22 and 23 include the phase “wherein the
column consists essentially of.” (Id. at 6.) The Examiner further found that
“the originally-filed disclosure is silent with regard to the terms of degree
‘substantially free of. . . and ‘consists essentially of,’” and that “the words
‘substantially’ and ‘essentially’ are not even found in the text of the instant
specification.” (Id.)
Appellants waived any argument regarding Rejection No. 1 by failing
to respond thereto. 37 C.F.R. § 41.37(c)(l)(iv). Accordingly, we affirm the
rejection of claims 1—16, 18, 19, and 21—23 under 35 U.S.C. § 112, first
paragraph.
8 All of claims 2—11 and 13—16, 18, and 19 depend on claims 1 or 12. (Br.
13—16.) Claim 21 recites “[a] kit comprising the multi-analyte column
according to claim 1 and instructions for use.” (Br. 16.)
4
Appeal 2014-005626
Application 11/600,989
Rejection No. 2
The Examiner found that claims 1—16, 18, 19, and 21—23 were
indefinite due to their respective recitations of “substantially free of’ or
“consists essentially of.” (Final Act. 7.) The Examiner further found that
“there is no indication that one of ordinary skill in the art would be apprised
of the scope of the instant claims.”9 (Id.)
Appellants waived any argument regarding Rejection No. 2 by failing
to respond thereto. 37 C.F.R. § 41.37(c)(l)(iv). Accordingly, we affirm the
rejection of claims 1—16, 18, 19, and 21—23 under 35 U.S.C. § 112, second
paragraph.
Conclusion
A preponderance of evidence of record supports the Examiner’s
conclusion that claims 1—16, 18, 19, and 21—23 fail to satisfy the written
description requirement of 35 U.S.C. § 112, first paragraph, and are
indefinite under 35 U.S.C. § 112, second paragraph.
9 We note that the phrase “consisting essentially of,” when used as a
transitional phrase, has been held to limit the scope of a claim to the
specified elements or steps “and those that do not materially affect the basic
and novel characteristic(s)” of the claimed invention. In re Herz, 537 F.2d
549, 551—52 (CCPA 1976). However, the instant Specification does not
indicate what the Appellants “regarded as constituting a material change in
the basic and novel characteristics of the invention.” See PPG Indus, v.
Guardian Indus. Corp., 156 F.3d 1351, 1355 (Fed. Cir. 1998). Accordingly,
on these facts, we agree that the Examiner has established a prima facie case
that claims 22 and 23 are indefinite. See MPEP 2111.03 (“The
determination of what is or is not excluded by a transitional phrase must be
made on a case-by-case basis in light of the facts of each case.”)
5
Appeal 2014-005626
Application 11/600,989
Preface to Discussion of Prior Art Rejections
We are instructed that, before a decision based on a prior art rejection
can be made, “it is essential to know what the claims do in fact cover.” In re
Steele, 305 F.2d 859, 862 (CCPA 1962). Because all the claims on appeal
are indefinite—which Appellants do not dispute—we address the remaining
rejections accordingly.
Issue—Anticipation
Whether a preponderance of evidence of record supports the
Examiner’s finding of anticipation under 35 U.S.C. § 102(b).
Analysis
Rejection No. 3
The Examiner found that Ofitserova-5, as evidenced by the Powers
Declaration, discloses each and every limitation of claims 1—16, 18, 19, and
21—23. (Final Act. 7—10.) However, because claims 1—16, 18, 19, and 21—
23 are indefinite, Rejection No. 3 as applied to those claims must fall, pro
forma, as it is necessarily based on a speculative assumption as to the scope
of the claims. See Steele, 305 F.2d at 862—63. We emphasize, however, that
because we are unable to ascertain the scope of claims 1—16, 18, 19, and 21—
23, we have not considered the merits of the anticipation rejection and
express no view as to the application of the prior art against those claims.
Issues—Obviousness
Whether a preponderance of evidence of record supports the
Examiner’s conclusion of obviousness under 35 U.S.C. § 103(a).
6
Appeal 2014-005626
Application 11/600,989
Analysis
Rejections No. 4 and 5
The Examiner concluded that the combination of Ofitserova-5, as
evidenced by the Powers Declaration, and Scott would have rendered claims
1—16, 18, 19, and 21—23 obvious to a person of ordinary skill in the art at the
time of the invention. (Final Act. 11—16.) The Examiner further concluded
that claim 19 would also have been rendered obvious by the combination of
those references along with Phillips. (Id. at 16—17.)
Because claims 1—16, 18, 19, and 21—23 are indefinite, Rejection Nos.
4 and 5 as applied to those claims must fall, pro forma, as those rejections
are necessarily based on a speculative assumption as to the scope of the
claims. See Steele, 305 F.2d at 862—63. We emphasize, however, that
because we are unable to ascertain the scope of claims 1—16, 18, 19, and 21—
23, we have not considered the merits of the obviousness rejections and
express no view as to the application of the prior art against those claims.
Issue—Obviousness-type Double Patenting
Whether a preponderance of evidence of record supports the
Examiner’s conclusion that claims 1—16, 18, 19, and 21—23 are unpatentable
on the ground of obviousness-type double patenting.
Analysis
Rejection No. 6
The Examiner concluded that claims 1—16, 18, 19, and 21—23 were
unpatentable, under the judicially created doctrine of obviousness-type
double patenting, over claims 1—19 of the ’032 patent. (Final Act. 17—18.)
However, because claims 1—16, 18, 19, and 21—23 are indefinite, Rejection
No. 6 as applied to those claims must fall, pro forma, as that rejection is
7
Appeal 2014-005626
Application 11/600,989
necessarily based on a speculative assumption as to the scope of the claims.
See Steele, 305 F.2d at 862—63. We emphasize, however, that because we
are unable to ascertain the scope of claims 1—16, 18, 19, and 21—23, we have
not considered the merits of the obviousness-type double patenting rejection
and express no view as to the application of that doctrine against those
claims.
SUMMARY
We affirm the rejection of claims 1—16, 18, 19, and 21—23 under
35 U.S.C. § 112, first paragraph.
We affirm the rejection of claims 1—16, 18, 19, and 21—23 under
35 U.S.C. § 112, second paragraph.
We reverse, pro forma, the rejection of claims 1—16, 18, 19, and
21-23 under 35 U.S.C. § 102(b).
We reverse, pro forma, the rejection of claims 1—16, 18, 19, and
21-23 under 35 U.S.C. § 103(a).
We reverse, pro forma, the rejection of claim 19 under 35 U.S.C.
§ 103(a).
We reverse, pro forma, the rejection of claims 1—16, 18, 19, and
21—23 for obviousness-type double patenting.
TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).
AFFIRMED
8