Ex Parte Santo et al

Patent Trial and Appeal Board

Aug 4, 2016

12668551 (P.T.A.B. Aug. 4, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
12/668,551 06/09/2010 Evan Edward Santo
24737 7590 08/08/2016
PHILIPS INTELLECTUAL PROPERTY & STANDARDS
465 Columbus A venue
Suite 340
Valhalla, NY 10595
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.
2007P01237WOUS 7042
EXAMINER
THOMAS, DAVID C
ART UNIT PAPER NUMBER
1637
NOTIFICATION DATE DELIVERY MODE
08/08/2016 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):
marianne.fox@philips.com
debbie.henn@philips.com
patti. demichele@Philips.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte EV AN EDWARD SANTO, NEVENKA DIMITROV A, and
CHIEN TING CHIEN
Appeal2014-005187
Application 12/668,551 1
Technology Center 1600
Before FRANCISCO C. PRATS, TA WEN CHANG, and RYAN H. FLAX,
Administrative Patent Judges.
FLAX, Administrative Patent Judge.
DECISION ON APPEAL
This is a decision on appeal under 35 U.S.C. § 134(a) involving
claims directed to a composition for gene expression analysis having
microbubbles and a mammalian expression vector system. Claims 1-13, 15,
and 16 are on appeal as rejected under 35 U.S.C. § 112, first paragraph, and
§ 103(a). We have jurisdiction under 35 U.S.C. § 6(b ).
We affirm.
1 The Real Party in Interest is Koninklijke Philips Electronics N.V. App
Br. 2.
Appeal2014-005187
Application 12/668,551
STATEMENT OF THE CASE
The appealed claims can be found in the Claims Appendix of the
Appeal Brief. Claim 1 is the sole independent claim, is representative, and
reads as follows:
1. A composition for expression analysis comprising,
b. microbubbles,
c. a mammalian expression vector system comprising,
1. a first fluorescent reporter gene which is under the
control of a promoter which will ensure constitutive . . .
express10n m VIVO,
IL a second fluorescent reporter gene which is under the
control of a promoter that is not constitutively
expressed,
111. a mammalian origin of replication,
IV. a bacterial origin of replication,
v. a promoter for the first fluorescent reporter gene, and
vi. a promoter for the second fluorescent reporter gene
that is activatable and ubiquitously expressed.
App. Br. 13 (Claims App'x).
The following rejections are on appeal:
Claims 1, 3, 8 and 14 rejected under 35 U.S.C. § 112, second
paragraph, as indefinite.
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Claims 1-13 and 15 rejected under 35 U.S.C. § 103(a) over Tabor, 2
Daly, 3 and Greenleaf. 4
Claim 16 rejected under 35 U.S.C. § 103(a) over Tabor, Daly,
Greenleaf, and Jelesko. 5
DISCUSSION
The rejection of claims 1, 3, 8, and 14 under 35 US.C. § 112, second
paragraph, as indefinite.
The Examiner determined the claim language "a promoter for the
second fluorescent reporter gene that is activatable and ubiquitously
expressed," in-and-of itself, in view of the also-recited claim language, "a
second fluorescent reporter gene which is under the control of a promoter
that is not constitutively expressed," and in view of the Specification, was
indefinite. Final Action 2; Ans. 3, 16-18. The Examiner expressed
confi1sion as to how the recited second fluorescent reporter gene, which is
non-constitutively expressed and "activatable," could also be "ubiquitously
expressed." Id. The Examiner noted that the Specification did not provide
an explanation as to what "ubiquitously expressed" means in the context of
the invention, other than to indicate that it has the "common usage by one of
2 U.S. Patent Application Pub. No. US 2008/0119433 Al (published May
22, 2008) (hereinafter "Tabor").
3 U.S. Patent Application Pub. No. US 2004/0209274 A2 (published Oct. 21,
2004) (hereinafter "Daly").
4 U.S. Patent Application Pub. No. US 2003/0078227 Al (published Apr.
24, 2003) (hereinafter "Greenleaf').
5 U.S. Patent Application Pub. No. US 2002/0086428 Al (published July 4,
2002) (hereinafter "Jelesko").
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Application 12/668,551
skill in the art." Ans. 17; see also Spec. 8; 11. 24--26 (identifying, inter alia,
the term "ubiquitously"). We share the Examiner's confusion regarding this
claim language.
Appellants contend conclusively that claim 1 is "facially definite," but
for the sake of completeness of their argument point to the Specification as
evidence that the disputed claim language has discemable meaning to one of
ordinary skill in the art. App. Br. 4--6; Reply Br. 4. We agree with the
Examiner that the claim is not "facially definite."
The portions of the Specification cited by Appellants do not support
their argument. While the terms "ubiquitous" and "ubiquitously" are used in
the Appellants' quoted portions of the Specification, such use does not shed
light on how (or where) the gene to be studied, i.e., the "second fluorescent
reporter gene," can be ubiquitously expressed and also conditionally (or not
constitutively) expressed. The cited portions of the Specification relate to
the also-recited control reporter gene, i.e., the "first fluorescent reporter
gene," which is constitutively expressed. Appellants appear to conflate
these two components of the claimed "composition for expression analysis"
(as they also appear to conflate 35 U.S.C. § 112 first and second
paragraphs).
Appellants have not explained how a gene that is conditionally
expressed is also ubiquitously expressed or how/where the ubiquitous
expression occurs in the "composition for expression analysis." Even if we
were to agree that the language at issue has descriptive support under§ 112,
first paragraph, the disputed claim language is not less confusing after
Appellants' argument than before.
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Application 12/668,551
For the above reasons we find the preponderance of the evidence
supports sustaining the respective rejection.
The rejection of claims 1-13and15 under 35 US.C. § 103(a) over
Tabor, Daly, and Greenleaf and the rejection of claim 16 under 35 US.C.
§ 103 (a) over the same combination and Jelesko.
While Steele counsels that a prior art rejection cannot be sustained if
the hypothetical person of ordinary skill in the art would have to make
speculative assumptions concerning the meaning of claim language (see In
re Steele, 305 F.2d 859, 862-863 (CCPA 1962)), our analysis of Appellants'
arguments on obviousness does not depend on the construction of the
limitation, "activatable and ubiquitously expressed." Moreover, Appellants
do not contend this claim element presents a patentable distinction over the
cited art. See App. Br. 6-10. Thus, we will address the obviousness
rejections in the interests of compact prosecution. We also address both
obviousness rejections together because Appellants rely on the same
arguments for each. Only claim 1 is argued by Appellants; therefore, all
claims fall therewith. 37 C.F.R. § 41.37(c)(l)(iv).
The Examiner determined the claims were obvious under 35 U.S.C.
§ 103(a) over the combination of Tabor, Daly, and Greenleaf(and in the
case of claim 16, also Jelesko ). The Examiner determined the combination
taught and suggested the use of microbubbles and ultrasound to transfect
(into cells) a vector with a constitutively expressed promoter and
fluorescent-reporter control gene and an inducibly (not-constitutively)
expressed promoter and fluorescent-reporter test-subject gene, each
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Application 12/668,551
encoding a different fluorescent color (as well as a mammalian and bacterial
origin of replication). Final Action 3-15 and Ans. 18-24.
We adopt the Examiner's findings of fact, reasoning on scope and
content of the prior art, and conclusions set out in the Final Action and
Answer. We identify the following only to highlight certain facts:
FINDINGS OF FACT
FF 1. Daly disclosed:
In some embodiments, pairs or sets of plasmids are provided,
each containing one or more of the RNA destabilizing sequences
described above in operable linkage with a polynucleotide
encoding a destabilised reporter protein such as, for example,
dlEGFP, dlEYFP, dlECFP or dlHcRed. One plasmid (the
control) from each pair or set contains a promoter 5' of the
reporter encoding region. The promoter comprises one or more
elements which are modulatable (i.e., inducible or repressible)
by exogenous treatments (e.g., the TRE combined with a
minimal promoter such as mC1\1V; see Figure 2c ). Alternatively,
a constitutively active promoter such as TS, SV40, CMV, TK or
RSV is used (see Figure 2b) .... The otherplasmid(s) in the pair
or set are identical to the control plasmid, except that a cloning
site (MCS) replaces the promoter, and the reporter encoding
region encodes a reporter similar to but distinguishable from the
control reporter (see Figure 2a). In some embodiments, the
control plasmid encodes a destabilised variant of EGFP (e.g.,
dlEGFP, dlEYFP or dlECFP) and the other vectors (test vectors)
each encode a different colour variant from the same list or
dlHcRed or other destabilised fluorescent protein (same protein
half-life). In other embodiments, a control and one of the test
reporters are incorporated into a single vector, such as for
example a bi-directional plasmid (see Figure 3).
Daly i-f 190; see also Final Action 9-12 and Ans. 9-13, 19-24 (discussing
Daly).
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FF2. Daly disclosed:
Sets of reporter vectors or parts thereof that encode similarly
destabilised mRNAs (similar to other vectors in the same set),
which in tum, encode similarly (similar to other vectors in the
same set) destabilised variants of EGFP or DsRed or other
fluorescent markers. One or more vectors (control vectors)
within each set contain a constitutive promoter (e.g., SV40,
CMV, RSV, TK, TS; see Figure 2b) or an inducible promoter
(e.g., TRE-mCMV; see Figure 2c), whereas the other vectors
(test vectors) within each set contain a cloning site (e.g., MCS)
in place of the promoter (e.g., see Figure 2a). Applications of
these vectors include but are not limited to the study or
measurement of promoter activity. For example, a promoter
element of interest can be cloned into the MCS of a test vector
encoding dlEGFP and reporter expression measured relative to
that of a control vector expressing dlEYFP. Also claimed is each
individual vector described well as bi-directional vectors or other
single vector systems that incorporate one test and one control
reporter construct within the same vector (e.g., Figure 3a and
Figure 3b ). Compared to existing sets of reporter vectors, the
vector sets claimed here offer the follov,ring advantages: (a) i\.
measurement of promoter activity that is closer to real-time.
Daly if 254; see also Final Action 9--12 and Ans. 8-13, 19--24 (discussing
Daly).
ANALYSIS
Appellants' arguments do not persuade us that a preponderance of the
evidence of record fails to support the Examiner's prima facie case that the
claims would have been obvious over the cited prior art combination. We
address Appellants' arguments below.
Appellants do not dispute the Examiner's rationale for combining the
cited references, but first contend the rejection(s) fails to consider that the
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Application 12/668,551
first and second genes recited by claim 1 are fluorescent reporter genes.
App. Br. 8. Second, Appellants contend, while Daly may disclose a single
vector with two reporter genes, there is no disclosure of a first fluorescent
reporter gene constitutively expressed and a second fluorescent reporter gene
not constitutively expressed. App. Br. 9; Reply Br. 5.
As to the first contention, the Examiner determined Tabor disclosed
the first fluorescent reporter gene (e.g., operably linked to a constitutive
promoter, which can be the green fluorescent reporter gene) of claim 1. See
Final Action 4. Further, the Examiner also determined Daly disclosed
reporter genes encoding different fluorescent colors. FFl, FF2; see also
Final Action 9 (discussing such disclosure of Daly). Moreover, and not
disputed by Appellants, the Examiner determined Greenleaf disclosed
fluorescence-based reporter genes for testing transfection efficiency. Final
Action 11. The Examiner has not overlooked the fluorescent nature of the
recited genes; therefore, Appellants' respective argument is not convincing.
As to Appellants' second contention, the Examiner cited Daly
(i-fi-f 190, 254) for its disclosure of a single vector with two reporter genes,
one a constitutively expressed control gene and one inducibly expressed test
gene, each encoding different fluorescent color (e.g., ECFP, EYFP, ECFP,
HcRed); the control gene being controlled by either an inducible or a
constitutive promoter and the test gene also being controlled by either an
inducible or a constitutive promoter (e.g., for an in vivo expression test using
a variety of effector substances, such as pharmaceuticals, allergens, toxins,
carbohydrates, miRNA). See FFl, FF2; see also Ans. 10-11 (discussing
Daly). Thus, the Examiner identified and correctly determined that Daly
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Application 12/668,551
taught two separate fluorescent reporter genes, one being a control and one
where expression is to be studied, where the control can optionally be
constitutively expressed and the study gene can optionally be conditionally
expressed, i.e., not constitutively expressed. Therefore, Appellants'
arguments are not persuasive.
For the above reasons, Appellants do not persuade us that the
preponderance of the evidence of record fails to support the Examiner's
position that claim 1 would have been obvious over Tabor, Daly, and
Greenleaf (and in the case of claim 16, also Jelesko ). The respective
rejections are, therefore, affirmed. Appellants have only argued claim 1, so
claims 2-13, 15, and 16 fall therewith. 37 C.F.R. § 41.37(c)(l)(iv).
SUMMARY
The rejection of claims 1, 3, 8, and 14 under 35 U.S.C. § 112, second
paragraph, as indefinite is affirmed.
The rejection of claims 1-13 and 15 under 35 U.S.C. § 103(a) over
Tabor, Daly, and Greenleaf is affirmed.
The rejection of claim 16 under 35 U.S.C. § 103(a) over Tabor, Daly,
Greenleaf, and J elesko is affirmed.
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
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