Ex Parte Maus et al

Patent Trial and Appeal Board

Mar 20, 2017

12583832 (P.T.A.B. Mar. 20, 2017)

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.
12/583,832 08/26/2009 Courtney E. Maus BECTON 3.0-022 9607
63863 7590 03/22/2017
David W. Highet, VP & Chief IP Counsel
Becton, Dickinson and Company
(Lerner David Littenberg)
1 Becton Drive , MC 110
Franklin Lakes, NJ 07417-1880
EXAMINER
CHUNDURU, SURYAPRABHA
ART UNIT PAPER NUMBER
1637
NOTIFICATION DATE DELIVERY MODE
03/22/2017 ELECTRONIC
Please find below and/or attached an Office communication concerning this application or proceeding.
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PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte COURTNEY E. MAUS and RAY A. McMILLIAN1
Appeal 2016-001078
Application 12/583,832
Technology Center 1600
Before JOHN G. NEW, ELIZABETH A. LaVIER, and RICHARD J.
SMITH, Administrative Patent Judges.
SMITH, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35U.S.C. § 134 involving claims to a kit
comprising a probe set for the amplification detection of Chlamydia
trachomatis. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm-in-part.
1 According to Appellants, the real party in interest is Becton, Dickinson and
Company. (Appeal Br. 1.)
Appeal 2016-001078
Application 12/583,832
STATEMENT OF THE CASE
Claims on Appeal
Claims 17, 19—21, 23, 24, and 27—29 are on appeal.2 (Claims
Appendix, Appeal Br. 20-24.) Claims 17 and 27 are illustrative and read as
follows:
17. A kit comprising:
a probe set for the amplification detection of Chlamydia trachomatis
that contains a cytotoxin gene (SEQ ID NO:l) comprising:
a) one or more primers wherein the one or more primers
comprises a target binding region selected from the group
consisting of SEQ ID NO: 12, SEQ ID NO: 13 and
oligonucleotide sequences that are at least 70% homologous
to SEQ ID NO: 12 and SEQ ID NO: 13;
b) at least one detector comprising a non-naturally occurring
detectable marker and an oligonucleotide sequence that binds
to the region of the cytotoxin gene for Chlamydia trachomatis
amplified by the one or more primers.
(Id. at 22-23.)
27. The kit of claim 17 wherein the probe set consists essentially of first and
second primers and the probe wherein the oligonucleotide sequence of the
first primer consists essentially of SEQ ID NO: 12 and the oligonucleotide
sequence of the second primer consists essentially of SEQ ID NO: 13 and the
probe oligonucleotide sequence consists essentially of SEQ ID NO: 14.
(Id. at 24.)
Examiner’s Rejections
1. Claims 17, 19—21, 23, 24, and 29 stand rejected under 35 U.S.C.
2 Claims 1—16 and 25—26 are withdrawn. (Final Act. dated Sept. 8, 2014, at
2.) Claim 18 is cancelled (id.), although it is incorrectly included in the
Examiner’s restatement of Rejection No. 1 in the Answer (Ans. 2). Claim
22 is also cancelled (Final Act. 2), although Rejection No. 1 incorrectly
includes “claim 22 (in part)” (Ans. 2). (See also Appeal Br. 2.)
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Application 12/583,832
§ 103(a) as unpatentable over Trama3 and Stratagene Catalog.4 (Final Act.
7-10.)
2. Claims 27 and 28 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Trama, Stratagene Catalog, and Lowe.5 (Ans. 4—6.)
FINDINGS OF FACT
We adopt as our own the Examiner’s findings regarding the scope and
content of the prior art, and reasons to combine the cited references, with
respect to Rejection No. 1. The following findings are included for
emphasis and reference purposes.
FF 1. The Examiner finds that “Trama [] teach[es] a composition of claim
17, for detecting Chlamydia trachomatis comprising a pair of primers and a
detector probe that bind to the highly conserved region ... of the cytotoxin
gene.” (Ans. 2, citing Trama Tflf 6—10 and claims 35—39.)
FF 2. The Examiner finds that Trama teaches one primer comprising an
oligonucleotide having at least 70% sequence identity with claimed SEQ ID
NOs 12 or 13; namely, SEQ ID NO: 12 having 94.4% homology with Trama
SEQ ID NO:24 and SEQ ID NO: 13 having 90.9% homology with Trama
SEQ ID NO:22. (Ans. 3^1 and 7-8.)
FF 3. The Examiner finds that Trama teaches that the detector probe
comprises an oligonucleotide having 100% sequence identity between the
claimed sequence of SEQ ID NO: 14 and Trama SEQ ID NO:24. (Ans. 2—3
and 9.)
3 Trama et al., US 2007/0269810 Al, published Nov. 22, 2007 (“Trama”).
4 Gene Characterization Kits, Stratagene Catalog 39 (1988) (“Stratagene”).
5 T. Lowe et al., A computer program for selection of oligonucleotide
primers for polymerase chain reactions, 18(7) Nucleic Acids Res., 1757—
61 (1990) (“Lowe”).
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Application 12/583,832
FF 4. The Examiner finds that Stratagene “teaches gene characterization
kit[s] which include[] formatting kit components.” (Ans. 4.)
FF 5. The Examiner finds that
[o]ne of the ordinary person skilled in the art would have been
motivated to combine the composition of Trama [] into a kit
format taught by Stratagene [] because Stratagene [] explicitly
teaches assembling [] gene characterizing components into a kit
format which provides premixed ready to use reaction mixture,
that saves money and resources [] by dramatically reducing
waste.
(Ans. 4.)
DISCUSSION
Issue
Whether a preponderance of evidence of record supports the
Examiner’s rejections under 35 U.S.C. § 103(a).
Analysis
Rejection No. 1
We agree with and adopt the Examiner’s findings, analysis, and
conclusions as set forth in the Final Action (Final Act. 7—10) and Answer
(Ans. 2-4 and 6—9) with respect to the rejection of claims 17, 19-21, 23, 24,
and 29. We discern no error in the Examiner’s rejection of those claims as
obvious. Appellants’ arguments are addressed below.
Claim Construction
Claim 17 uses the open-ended term “comprises” in referring to the
“one or more primers,” and the open-ended term “comprising” in referring
to the “at least one detector.” (Appeal Br. 22—23.) Use of those open-ended
terms thus includes (1) primer(s) that contain sequences in addition to “SEQ
ID NO: 12, SEQ ID NO: 13 and oligonucleotide sequences that are at least
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Application 12/583,832
70% homologous to SEQ ID NO: 12 and SEQ ID NO: 13,” and (2)
detector(s) that contain sequences in addition to “an oligonucleotide
sequence that binds to the region of the cytotoxin gene for Chlamydia
trachomatis amplified by the one or more primers,” without falling outside
the scope of claim 17. (Ans. 7—8.) See Genentech, Inc. v. Chiron Corp., 112
F.3d 495, 501 (Fed. Cir. 1997). Similarly, claim 19 uses the open-ended
term “comprises” in referring to “the detector oligonucleotide sequence,”
thereby including sequences in addition to “SEQ ID NO: 14, and
oligonucleotide sequences that are at least 70% homologous to SEQ ID
NO: 14,” without falling outside the scope of claim 19. (Appeal Br. 23; see
also Genentech, 112 F.3d at 501.)
Appellants acknowledge some homology between claimed SEQ ID
NOs 12 and 13, and Trama’s SEQ ID NOs 24 and 22, respectively. (Appeal
Br. 9—11; see, e.g., “Applicants’ SEQ ID NO: 12 is a small fragment of
Trama’s SEQ ID NO:24.”). Appellants also acknowledge that “SEQ ID
NO: 14 is but a fragment of SEQ ID NO:24 of Trama.” (Appeal Br. 11.)
Appellants nevertheless argue that Trama’s sequences are distinguishable
from the claimed sequences due to deletion points, length, or purpose. (See
Appeal Br. 4—7; Reply Br. 2-4.) However, as the claims are properly
construed, we discern no error in the Examiner’s reliance of Trama for
teaching the primer(s) and detector(s) recited in claims 17 and 19. (See FF
1-3.)
Claim 17
Appellants argue that “[t]he entire focus of the assay disclosed in
Trama is the synthesis and detection of the sequence-specific amplicons . . .
each containing a point of the deletion” whereas “the present invention
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Application 12/583,832
exploits the highly conserved nature of a portion of the cytotoxin gene.”6
(Appeal Br. 6.) Appellants argue further that Trama teaches away from the
claimed invention because its assay is “based upon the reasoning that the
deletion point (or variations) in the cytotoxin gene sequence can be used to
detect [] specific serotypes,” and because Trama “expressly instructs the
skilled person to take advantage of regions of the cytotoxin gene that contain
deletion points for the purpose of specifically identifying those serotypes
that cause Lymphogranuloma Venerum.” (Appeal Br. 8.)
We are not persuaded. As an initial matter, the fact that Trama may
use primers and probes for the cytotoxin gene in connection with serotypes
or deletion points does not diminish its applicability to Appellants’ claimed
invention. See Cross Med. Prods., Inc. v. Medtronic Sofamor Danek, Inc.,
424 F.3d 1293, 1323 (Fed. Cir. 2005) (“One of ordinary skill in the art need
not see the identical problem addressed in a prior art reference to be
motivated to apply its teachings.”). Moreover, Tama does not teach away
because it does not criticize, discredit, or otherwise discourage the claimed
invention. See In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004).
Accordingly, we are not persuaded of any error in the Examiner’s rejection
of claim 17 for obviousness.7
6 While Appellants argue the unexpected discovery of this highly conserved
region of the cytotoxin gene, that contention does impart patentability to the
claims. See Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347 (Fed. Cir.
1999) (“[T]he discovery of a previously unappreciated property of a prior art
composition, or of a scientific explanation for the prior art’s functioning,
does not render the old composition patentably new to the discoverer.”).
7 We acknowledge, but are unpersuaded by, Appellants’ argument regarding
“hindsight.” (Reply Br. 1—4.) Appellants point to no evidence that any of
the Examiner’s findings were beyond the level of ordinary skill at the time
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Claim 19* * 8
Claim 19 (dependent on claim 17) is directed to the detector of claim
17 and, as discussed above, encompasses sequences in addition to SEQ ID
NO: 14 and oligonucleotide sequences at least 70% homologous to SEQ ID
NO: 14. (Appeal Br. 23.) Appellants argue that “[t]he detector
oligonucleotide disclosed in Trama is identified as SEQ ID NO:27,” and that
“[t]he Examiner has not alleged that SEQ ID NO:24 has the capacity to
hybridize to SEQ ID NO: 1.” (Appeal Br. 12—13.) Appellants’arguments
are otherwise similar to those advanced above (e.g., the “different function”
of Trama’s primers and probes).
We are not persuaded. While Trama discloses SEQ ID NO:27 as one
embodiment of a probe, Trama’s teachings are not limited to that sequence
as the probe. (See Trama 124: “In another embodiment, the oligonucleotide
probe comprises or consist of the nucleotide sequence of SEQ ID NO:27.”)
Moreover, a reference (such as Trama) ‘“must be considered not only for
what it expressly teaches, but also for what it fairly suggests.’” In re Baird,
16 F.3d 380, 383 (Fed. Cir. 1994) (quoting In re Burckel, 592 F.2d 1175,
1179 (CCPA 1979)). In addition, contrary to Appellants’ contention, the
Examiner has alleged that SEQ ID NO:24 has the capacity to hybridize to
SEQ ID NO: 1. (See, e.g., Ans. 2.) Accordingly, for these reasons and the
of the invention or could have been taken only from Appellants’
Specification. See In re McLaughlin, 443 F.2d 1392, 1395 (CCPA 1971).
8 Appellants state that “[t]he patentability of [claims 19-21 and 27] is []
argued separately from that of claim 17.” (Appeal Br. 12.) Claim 27 is
addressed below in connection with Rejection No. 2. We select claim 19 as
representative of the group of claims 19—21.
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Application 12/583,832
reasons set forth above in connection with claim 17, we affirm the rejection
of claim 19.
Conclusion of Law
A preponderance of evidence of record supports the Examiner’s
rejection of claims 17 and 19 under 35 U.S.C. § 103(a). Claims 20, 21, 23,
24, and 29 were not argued separately and fall with claim 17.
Rejection No. 2
Unlike claims 17 and 19, claim 27 uses “consisting essentially of’
language rather than “comprising” language, thereby limiting the claim to
the specified SEQ ID NOS: 12—14 and those elements (e.g., sequences) “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); see also Reply
Br. 4—5. The Examiner thus relies on Lowe for teaching “a computer
program for rapid selection of oligonucleotide primers for polymerase chain
reaction.” (Ans. 5, citing Lowe 1757, col. 1, abstract.) In addition,
according to the Examiner, “selection of specific oligonucleotides . . .
represents routine optimization with regard to sequence, length and
composition of the oligonucleotide, which routine optimization parameters
are explicitly recognized in Lowe.” (Ans. 6.)
Appellants argue that
nothing in Lowe [] mentions or discusses Chlamydia, or any of
its sequences. Lowe [] does not teach one of ordinary skill in the
art how to select a Chlamydia target for C. Trachomatis detection
(selective of other microorganisms) but does not over-select for
only specific serotypes, and design primers or probes for that
detection, as presently claimed.
At best, [] Lowe [] describe[s] a method for applying a
computer algorithm to provide primer and probe designs based
on a predetermined target and certain criteria.
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Application 12/583,832
(Appeal Br. 16.)
We understand Appellants’ argument to be, at least in part, that Lowe
does not recognize the claimed sequences (including their lengths and
compositions) to be result effective variables. See In re Antonie, 559 F.2d
618, 620 (CCPA 1977) (While “the discovery of an optimum value of a
variable in a known process is normally obvious,” an exception to that rule
is where “the parameter optimized was not recognized to be a result-
effective variable.”).
We find that Appellants have the better position. While the Examiner
states that the claimed sequence limitations are a matter of routine
optimization and recognized as such in Lowe, the Examiner does not point
to any specific teachings of Lowe that show a recognition of the claimed
sequences, lengths, and compositions as result-effective variables. The
Examiner’s statement is thus a conclusory allegation that cannot support a
prima facie case of obviousness. See In re Kahn, 441 F.3d 977, 988 (Fed.
Cir. 2006) (“[R]ejections on obviousness grounds cannot be sustained by
mere conclusory statements; instead, there must be some articulated
reasoning with some rational underpinning to support the legal conclusion of
obviousness”). Accordingly, the rejection of claim 27 is reversed. Claim 28
is dependent on claim 27 and the rejection thereof is likewise reversed.
Conclusion of Law
A preponderance of evidence of record fails to support the
Examiner’s rejection of claims 27 and 28 under 35 U.S.C. § 103(a).
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Application 12/583,832
SUMMARY
We affirm the rejection of claims 17, 19—21, 23, 24, and 29 (Rejection
No. 1). We reverse the rejection of claims 27 and 28 (Rejection No. 2).
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-IN-PART
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