Ex Parte Whitman et al

Patent Trial and Appeal Board

Aug 17, 2016

12826189 (P.T.A.B. Aug. 17, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
12/826, 189 06/29/2010 Douglas F. Whitman
108120 7590 08/19/2016
Parker Highlander PLLC
1120 S. Capital of Texas Hwy
Bldg 1, Suite 200
Austin, TX 78746
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.
LUMN.P0036US 2953
EXAMINER
CHUNDURU, SURYAPRABHA
ART UNIT PAPER NUMBER
1637
NOTIFICATION DATE DELIVERY MODE
08/19/2016 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):
docket@phiplaw.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte DOUGLAS F. WHITMAN and HONGWEI ZHANG
Appeal2015-003833
Application 12/826, 189 1
Technology Center 1600
Before DONALD E. ADAMS, RICHARD J. SMITH, and DAVID COTTA,
Administrative Patent Judges.
COTT A, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a nucleic
acid molecule. The Examiner rejected the claims on appeal as obvious
under 35 U.S.C. § 103(a).
We reverse.
1 According to Appellants, the real party in interest is Luminex Corporation.
App. Br. 3.
Appeal2015-003833
Application 12/826, 189
STATEMENT OF THE CASE
Claims 1-5, 10-11, 14, and 74--77 are on appeal. Claim 1 is
illustrative and reads as follows:
1. A nucleic acid molecule comprising:
(a) a target-specific primer sequence;
(b) an anti-tag sequence 5' of the target-specific
pnmer sequence;
(c) a tag sequence 5' of the anti-tag sequence; and
( d) a blocker between the anti-tag sequence and the
tag sequence.
The Examiner rejected claims 1-5, 10-11, 14, and 74--77 under
35 U.S.C. § 103 as being unpatentable over Whitman2 in view of
Whitcombe. 3 Ans. 2.
ANALYSIS
The nucleic acid molecule recited in the claims requires a specific
arrangement of elements. The claimed sequence of elements is clearly
illustrated in Figure IA (reproduced below).
2 Whitman et al., U.S. Patent Publication No. 2008/0305481 Al, published
Dec. 11, 2008 ("Whitman").
3 Whitcombe et al., U.S. Patent No. 6,326,145 Bl, issued Dec. 4, 2001
("Whi tcombe ").
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Appeal2015-003833
Application I2/826, I 89
"FIG. IA shows an illustration of a hairpin-forming primer and a capture
complex" (Spec. I 7: 6-7). As can be seen, the claimed nucleic acid includes
a primer, and anti-tag sequence 5' of the primer, a tag sequence 5' of the
anti-tag sequence, and a blocker (labeled "C-I 8 spacer" in Figure IA)
between the tag and anti-tag sequences.
Whitman discloses:
[A] first primer comprising a target specific sequence, a tag
sequence 5' of the target specific sequence, and a blocker
between the target specific sequence and the tag sequence, and
a second primer comprising a target specific sequence; a
labeling agent; and a plurality of probes (anti-tags)
complementary to the tag sequences of the plurality of primer
pairs, wherein the probes are immobilized on a plurality of
encoded magnetic beads such that the identity of each probe is
known from the encoded magnetic bead on which it is
immobilized.
Whitman i-f I 48. As reflected in the above passage, Whitman discloses two
separate nucleic acid molecules: a primer including three of the elements of
the claimed invention (a primer, a tag sequence, and a blocker), and a probe
including the remaining fourth claim element (an anti-tag sequence).
Whitcombe discloses:
We have now devised a novel detection system using a tailed
primer and an integrated signaling system. The primer has a
template binding region and a tail comprising a linker and a
target binding region. In use the target binding region in the tail
hybridizes to complementary sequence in an extension product
of the primer.
Whitcombe col. I, 11. 55---60. Whitcombe further discloses: "Conveniently
the linker comprises a blocking moiety which prevents polymerase mediated
chain extension on the primer template." Id. at col. 2, 11. 6I---63. An
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Appeal2015-003833
Application 12/826, 189
embodiment of Whitcombe' s molecule is depicted in Figure 6b and 6c
(reproduced below).
b
c
-- - - - .. ,.....
Figure 6b shows a nucleic acid molecule with a tail (the region between
blocking moiety "H" and fluorophore "F") and a template binding region
(the arrow). See generally, Whitcombe col. 11, 11. 41--47. As shown in
Figure 6c, when the nucleic acid molecule undergoes hybridization, a target
binding region in the tail hybridizes to an extension product of the template
binding region. Id.
The Examiner contends that "the broader scope of the nucleic acid
molecule as claimed reads on a primer or probe having tag and anti-tag
sequences or an extension product produced using said primers and probes."
Ans. 6. The Examiner thus contends that in applying Whitman and
Whitcombe to the claims, one should consider not just the starting nucleic
acid molecules, but the molecules resulting from hybridization. But even if
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Appeal2015-003833
Application 12/826, 189
one considers the nucleic acid detection systems of Whitman and
Whitcombe post-hybridization - i.e. after Whitman's anti-tag probes have
bound to the primer and after Whitcombe' s extension product has bound to
the target binding region in the tail - the arrangement of components in
Whitman and Whitcombe is different than that claimed. In Whitman, the
blocker is between the target specific sequence and the tag sequence, rather
than between the tag and anti-tag sequences as claimed. In Whitcombe,
even if one were to assume that the target binding region in the tail is a "tag
sequence" and that the primer extension product is an "anti-tag sequence,"
the post-hybridization end product would still have a different arrangement
of components than is claimed by Appellants. In particular, the template
binding region (which, under such assumptions, would correlate with the
claimed "target-specific primer sequence") would be between the tag and
anti-tag sequences rather than at the 3' end of the molecule as claimed by
AppeUants.
The Examiner contends that it would have been obvious to modify
Whitman in view of Whitcombe to arrive at the claimed arrangement of
components "for the purpose of developing an improved efficient target
detecting system." Ans. 5. The Examiner explains:
The ordinary artisan would have [sic] motivated to combine the
references because the artisan would have a reasonable
expectation of success that such a combination would result in
an efficient and sensitive signaling system for target nucleic
acid detection because Whitcombe et al. explicitly taught that
the linker comprises blocking moiety that prevents polymerase
mediated chain extension on the primer and tail comprises
nucleic acid placed 5 '-3' at 5' terminus of the primer, that is,
two sequences are placed back to back, wherein tail serves both
as a linker and a target binding region (see col. col. 1, line 66-
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Appeal2015-003833
Application 12/826, 189
67, col. 2, line 1, line 49-67, col. 3, line 1-5) and such
modification of the product would be obvious over the cited
prior art.
Id. It is not clear from the above, how, absent hindsight, the Examiner
contends the nucleic acid molecules of Whitman or Whitcombe would be
modified to arrive at Appellants' claimed invention. The Examiner does not
explain how the components of Whitman or Whitcombe would be
rearranged. Nor does the Examiner explain why such rearrangement would
improve upon the detection system of Whitman or Whitcombe beyond
making the conclusory assertion that the resulting molecule would be
"efficient and sensitive." In sum, we find that the Examiner has not
articulated sufficient reason to rearrange the components of Whitman and/or
Whitcombe to arrive at the claimed molecule. Accordingly, we reverse the
Examiner's decision to reject claims 1-5, 10-11, 14, and 74--77 as obvious
over Whitman and Whitcombe.
SUMMARY
For these reasons and those set forth herein, the Examiner's final
decision to reject claims 1-5, 10-11, 14, and 74--77 is reversed.
REVERSED
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