Ex Parte TEGGATZ et al

Patent Trial and Appeal Board

Oct 24, 2018

14267678 (P.T.A.B. Oct. 24, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
14/267,678 05/01/2014 Ross E. TEGGATZ
33649 7590 10/24/2018
Mr. Christopher John Rourk
Jackson Walker LLP
2323 ROSS A VENUE
SUITE 600
DALLAS, TX 75201
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.
136839.62
(10055/TRI-303)
4117
EXAMINER
FORMAN, BETTY J
ART UNIT PAPER NUMBER
1634
MAIL DATE DELIVERY MODE
10/24/2018 PAPER
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.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ROSSE. TEGGATZ and
DAVID WILLIAM PROVANCE 1
Appeal2017-004732
Application 14/267,678
Technology Center 1600
Before ERIC B. GRIMES, JOHN G. NEW, and JOHN E. SCHNEIDER,
Administrative Patent Judges.
GRIMES, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a
biosensor system, which have been rejected as indefinite, anticipated, and
obvious. We have jurisdiction under 35 U.S.C. § 6(b ).
We affirm-in-part and enter a new ground of rejection.
STATEMENT OF THE CASE
"[T]he invention relates [to] the ability to measure the presence and
quantity of multiple medically relevant components from biological fluid
1 Appellants identify the Real Party in Interest as TRIUNE IP LLC. Appeal
Br. 4.
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Application 14/267,678
through electronics." Spec. ,r 2. "[T]he disclosed Electronic Based Biosensor
... can detect and quantify multiple molecules of interest present in an
aqueous solution simultaneously and rapidly with high sensitivity and
specificity." Id. ,r 4. "[I]n an example of a preferred embodiment, the
biosensor system contains a biosensor component that consists of a DNA
oligonucleotide." Id. ,r 8. "[A]n exemplary preferred embodiment of the
biosensor component" includes "a segment of nucleotides (102) that together
form a unique sequence henceforth referred to as an idDNA identifier." Id.
Claims 11-3 0 are on appeal. Claims 11, 21, and 3 0 are the
independent claims and read as follows:
11. A biosensor system comprising:
a biosensor component;
one or more discrete and interconnected chambers;
a transducer capable of generating electric or magnetic fields;
one or more barriers between interconnected chambers that can be
controlled electronically;
one or more temperature zones that can be independently controlled;
one or more sub-wells with biomaterial and transducers capable of
generating specific electrical signals; and
wherein at least one subwell is configured to allow methylation and
cleavage of the biosensor component to release an idDNA identifier.
21. A biosensor system comprising:
a biosensor component;
one or more discrete and interconnected chambers;
a transducer capable of generating electric or magnetic fields;
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one or more barriers between interconnected chambers that can be
controlled electronically;
one or more temperature zones that can be independently controlled;
one or more sub-wells with biomaterial and transducers capable of
generating specific electrical signals to allow methylation and cleavage of
the biosensor component to release an idDNA identifier and to detect the
idDNA identifier.
30. A biosensor system comprising:
a biosensor component;
one or more sub-wells with biomaterial and transducers capable of
generating specific electrical signals to allow the sub-wells with the
biomaterial and the transducers to perform methylation and cleavage of the
biosensor component to release an idDNA identifier and to detect the
idDNA identifier.
The claims stand rejected as follows:
Claims 13-30 under 35 U.S.C. § 112, second paragraph, as indefinite
(Ans. 2);
Claims 11, 13-15, 21, 23, 24, and 30 under 35 U.S.C. § I02(a)(l) as
anticipated by, or alternatively under 35 U.S.C. § I03(a) as obvious based
on, Malcolm2 (Ans. 3);
Claims 11, 13-16, 21, 23-25, and 30 under 35 U.S.C. § I03(a) as
obvious based on Malcolm and Zenhausem3 (Ans. 6); and
Claims 11-30 under 35 U.S.C. § I03(a) as obvious based on
Malcolm, Zenhausem, and Hongfei4 (Ans. 7).
2 Malcolm, US 2009/0227476 Al, published Sept. 10, 2009.
3 Zenhausem et al., US 2004/0011650 Al, published Jan. 22, 2004.
4 Hongfei Yan et al., Hairpin Fluorescence DNA Probe for Real-Time
Monitoring of DNA Methylation, 79 Anal. Chem. 1050-1056 (2007).
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I
The Examiner has rejected claims 13-30 as indefinite. The Examiner
concludes that "[c]laims 13-20 are each indefinite for the recitation 'in a
Lab-on-a-Chip format according to Claim' because the recitation lacks
proper antecedent basis." Ans. 2. The Examiner also concludes that "Lab-
on-a-Chip" is indefinite "because it is unclear whether the recitation
attempts to define some structures in addition to the system of Claim 11.
Because Claims 13-20 do not define additional structures related to a Lab-
on-a-Chip it is unclear what may be encompassed by the recitation." Id.
The Examiner concludes that "[ c ]laims 21-29 are indefinite in Claim
20 [ sic, 21] for the recitation 'to allow methylation and cleavage of the
biosensor component to release an idDNA identifier and to detect the
idDNA identifier' because it is unclear whether the recitation is intended to
modify the electric signals, the transducers, the biomaterial or the sub-
wells." Id. at 3. The Examiner concludes that claim 30 is indefinite for the
same reason. Id.
We agree with the Examiner that the cited limitations render claims
13-30 indefinite. Claims 13-20 all recite a "biosensor system in a Lab on a
Chip format according to" either claim 11 or claim 12, which depends from
claim 11. However, claim 11 does not recite a "biosensor system in a Lab on
a Chip format." Thus, the Examiner correctly determined that this phrase in
the dependent claims lacks antecedent support.
We also agree with the Examiner that a "biosensor system in a Lab on
a Chip format" is indefinite because it is unclear whether this recitation
requires elements beyond those recited in claim 11. Specifically, claim 11
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requires only a chamber, a transducer that can generate electric or magnetic
fields, a barrier between chambers, a controllable temperature zone, and a
sub-well with biomaterial and transducers that can generate an electrical
signal.
By contrast, the Specification states that "a preferred embodiment of
the biosensor system is a lab-on-a-chip platform." Spec. ,r 17. The
Specification describes the lab-on-a-chip platform as including four
chambers and means of transferring a molecule of interest between the
chambers by electrical control. The Specification states that the first
chamber receives and mixes a biosensor component and an aqueous solution
to be tested; the second chamber contains a DNA methyl transferase and
mixes it with the solution from the first chamber through electrical control;
the third chamber contains a Type IIM restriction enzyme and cofactor( s) for
the methyl transferase; and the fourth chamber contains a transducer with
sub-wells manufactured with biomaterial, as well as electrical control for
mixing and thermal contro 1. Id.
Thus, the Specification describes a "lab-on-a-chip platform" as
including many elements beyond those required by claim 11. It is unclear
from the claim language, even read in light of the Specification, whether the
recitation in claims 13-20 of a "biosensor system in a Lab on a Chip format"
adds structural elements to those recited in claim 11 and, if so, what those
elements are.
Appellants argue that "[t]he use of 'a' in 'a lab-on-a-chip format'
provides the proper antecedent basis." Appeal Br. 8. Appellants also argue
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that lab-on-a-chip devices were known in the art, as evidenced by Malcolm.
Id.
These arguments are unpersuasive because, as discussed above, claim
11 does not identify the system defined by the claim as being in Lab on a
Chip format and neither the claim language nor the Specification make clear
what elements are required by Lab on a Chip format. The passage from
Malcolm that Appellants cite does not cure the indefiniteness of the claim
language, because it does not provide evidence that a person of ordinary skill
in the art would recognize "Lab on a Chip format" as requiring certain
elements or requiring no elements beyond those recited in claim 11.
With regard to claims 21-30, we agree with the Examiner that the
recitation of "sub-wells with biomaterial and transducers capable of
generating specific electrical signals to allow methylation and cleavage of
the biosensor component to release an idDNA identifier and to detect the
idDNA identifier" ( claim 21) and "sub-wells with biomaterial and
transducers capable of generating specific electrical signals to allow the sub-
wells with the biomaterial and the transducers to perform methylation and
cleavage of the biosensor component to release an idDNA identifier and to
detect the idDNA identifier" (claim 30) are indefinite because it is unclear
whether it is the sub-wells, the biomaterial, the transducers, or some
combination of these elements that "allow [ or perform] "methylation and
cleavage of the biosensor component" and "detect the idDNA identifier."
With respect to claims 21-29, Appellants argue that "the limitation
clearly states that the biosensor is methylated and cleaved, not the electric
signals, the transducers, the biomaterial or the sub-wells." Appeal Br. 8. The
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rejection, however, is not based on which element is methylated and cleaved
but which element(s) "allow methylation and cleavage of the biosensor
component," as recited in claims 21. See Ans. 3.
With respect to claim 30, Appellants argue that "[t]he one or more
sub-wells with biomaterial and transducers of claim 30 are capable of
generating specific electrical signals 1) to allow the sub-wells with the
biomaterial and the transducers to perform methylation and cleavage of the
biosensor component 2) to release an idDNA identifier and 3) to detect the
idDNA identifier." Appeal Br. 9. However, as discussed above, it is unclear
from the claim language whether the sub-wells, the biomaterial, the
transducers, or some combination of these elements "perform[ s] methylation
and cleavage of the biosensor component."
We affirm the rejection of claims 13-30 under 35 U.S.C. § 112,
second paragraph.
II
The Examiner has rejected all of the claims on appeal under 35 U.S.C.
§ 102(a)(l) or 35 U.S.C. § 103(a) based on one or more of Malcolm,
Zenhausem, and Hongfei. We reverse all of the prior art rejections on
procedural grounds because we conclude the claim language is indefinite,
for the reasons discussed in the new ground of rejection below. See In re
Steele, 305 F.2d 859, 862 (CCPA 1962). It should be understood, however,
that the reversal is not based on the merits of the§§ 102(a)(l) and 103(a)
rejections. If the indefiniteness issues are resolved, the cited references are
available as prior art if the Examiner decides later in prosecution that they
support a rejection of the claims.
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III
Under the provisions of 37 C.F.R. § 41.50(b ), we enter the following
new ground of rejection:
Claims 11-30 are rejected under 35 U.S.C. § 112, second paragraph,
as indefinite. Each of claims 11, 21, and 30 ( all of the independent claims)
recites a "biosensor component" but does not define this component in
structural terms. The Specification does not define what is meant by a
"biosensor component." The Specification states that, in "a preferred
embodiment, the biosensor system contains a biosensor component that
consists of a DNA oligonucleotide." Spec. ,r 8. The Specification also states
that "preferred embodiments ... include a synthetic DNA oligonucleotide
that forms ... a hairpin structure." Id. ,r 9. In "a preferred embodiment ...
the biosensor component ... has a segment of bases at the three or five
prime end that constitute a unique identifiable sequence." Id. ,r 10. "[A]n
exemplary preferred embodiment ... is the combination of the hairpin
structure with the unique identifiable sequence." Id. ,r 11. In preferred
embodiments, the biosensor component "contains within its sequence a
portion that forms the stem of the hairpin described immediately above the
sequence targeted by both a DNA methyl transferase and a Type IIM DNA
restriction enzyme." Id. ,r 12.
Thus, the Specification states that a preferred embodiment of the
biosensor component can consist of a DNA oligonucleotide, and the
oligonucleotide can include a hairpin structure, which can form a sequence
targeted by a DNA methyl transferase and Type IIM restriction enzyme, or a
unique identifiable sequence at the 3' or 5' end of the oligonucleotide, or
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both. Claims 11, 21, and 30, however, require none of those structural
features and therefore are not limited to any of the preferred embodiments
that are described in the Specification. The scope of the "biosensor
component" recited in the claims is therefore unclear and the claims are
indefinite on that basis.
Each of claims 11, 21, and 30 also recites an "idDNA identifier,"
which is not defined structurally in the claims. The Specification states that
"an example of an exemplary preferred embodiment of the biosensor
component is shown" in Figure 1. Spec. ,r 36. "The biosensor component
(100) is composed of a DNA oligonucleotide synthesized chemically to
present ... a segment of nucleotides (102) that together form a unique
sequence henceforth referred to as an idDNA identifier." Id.
"Figure 1 is a simplified schematic drawing of an exemplary preferred
embodiment of the biosensor component." Id. ,r 20. Figure 1 includes an
element represented as "3' Unique idDNA Sequence." Id., Fig. 1. No further
definition of an idDNA identifier is provided by the Specification. "Figure
13 shows a list of potential sequences that can comprise the unique idDNA
identifier." Id. ,r 32. However, the Specification provides no explanation of
what makes the sequences of Figure 13 "unique" or what structural
element(s) would need to be present in order for a given DNA segment to
constitute "an idDNA identifier," as recited in the claims. Because the scope
of the "idDNA identifier" recited in the claims is unclear, the claims are
indefinite on that basis.
Claims 11 and 21 are also indefinite on another basis. Both of these
claims (and therefore the claims that depend from them) recite "one or more
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discrete and interconnected chambers." They therefore encompass systems
having only a single chamber. However, both of claims 11 and 21 also recite
"one or more barriers between interconnected chambers." The claims
therefore require a barrier between interconnected chambers, even if the
system includes only a single chamber. Claims 11-29 are therefore
indefinite on this basis as well.
Finally, each of claims 11, 21, and 30 recites subwells that are
"configured to" or "capable of' allowing or performing certain functions.
Claim 11 recites "at least one sub well [that] is configured to allow
methylation and cleavage of the biosensor component to release an idDNA
identifier." Claim 21 recites "one or more sub-wells with biomaterial and
transducers capable of generating specific electrical signals to allow
methylation and cleavage of the biosensor component." Claim 30 recites
"one or more sub-wells with biomaterial and transducers capable of
generating specific electrical signals to allow the sub-wells with the
biomaterial and the transducers to perform methylation and cleavage of the
biosensor component."
The Specification describes an "embodiment of the invention [that]
includes a Lab-on-a-chip platform." Spec. ,r 44. That embodiment includes a
final well (408) [that] is a semiconductor material which
consists of array of many sub-wells as well as many transducers
that can be spatially independent for measurement. ... Each
sub-well has bio-material that additionally combines with the
idDNA identifiers specifically. The transducers in each sub-
well can electrically recognize the unique combination of the
bio-material and the idDNA identifiers.
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However, the description of the Lab-on-a-chip embodiment and the
rest of the Specification fail to describe the structural elements of the sub-
wells that make them "configured to allow methylation and cleavage of the
biosensor component" ( claim 11) or that "allow methylation and cleavage of
the biosensor component" ( claim 21) or that "allow the sub-wells with the
biomaterial and the transducers to perform methylation and cleavage of the
biosensor component" ( claim 30). Because the structure required by claims
11, 21, and 30 is unclear, even when the claim language is read in light of
the Specification, the claims are indefinite on this basis as well.
Claims 12-20 and 22-29 depend from either claim 11 or claim 21 and
are therefore indefinite because they incorporate the limitations of one of the
indefinite independent claims.
SUMMARY
We reverse the rejections under 35 U.S.C. §§ 102(a)(l) and 103.
We affirm the rejection under 35 U.S.C. § 112, second paragraph.
We enter a new ground of rejection under 35 U.S.C. § 112, second
paragraph.
TIME PERIOD FOR RESPONSE
This decision contains a new ground of rejection pursuant to 37
C.F.R. § 4I.50(b). Section 4I.50(b) provides "[a] new ground of rejection
pursuant to this paragraph shall not be considered final for judicial review."
Section 41.50(b) also provides:
When the Board enters such a non-final decision, the appellant,
within two months from the date of the decision, must exercise
one of the following two options with respect to the new ground
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of rejection to avoid termination of the appeal as to the rejected
claims:
(1) Reopen prosecution. Submit an appropriate
amendment of the claims so rejected or new Evidence relating to
the claims so rejected, or both, and have the matter reconsidered
by the examiner, in which event the prosecution will be
remanded to the examiner. The new ground of rejection is
binding upon the examiner unless an amendment or new
Evidence not previously of Record is made which, in the opinion
of the examiner, overcomes the new ground of rejection
designated in the decision. Should the examiner reject the claims,
appellant may again appeal to the Board pursuant to this subpart.
(2) Request rehearing. Request that the proceeding be
reheard under§ 41.52 by the Board upon the same Record. The
request for rehearing must address any new ground of rejection
and state with particularity the points believed to have been
misapprehended or overlooked in entering the new ground of
rejection and also state all other grounds upon which rehearing
is sought.
Further guidance on responding to a new ground of rejection can be
found in the Manual of Patent Examining Procedure§ 1214.01.
AFFIRMED-IN-PART, 37 C.F.R. § 4I.50(b)
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