Ex Parte Bengtsson et al

Patent Trial and Appeal Board

Jan 23, 2017

10585867 (P.T.A.B. Jan. 23, 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.
10/585,867 05/07/2009 Thomas Bengtsson 10400-000091/U S/NPB 1639
28997 7590 01/25/2017
HARNESS, DICKEY, & PIERCE, P.L.C
7700 Bonhomme, Suite 400
ST. LOUIS, MO 63105
EXAMINER
LYONS, MARY M
ART UNIT PAPER NUMBER
1645
NOTIFICATION DATE DELIVERY MODE
01/25/2017 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):
stldocket@hdp.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte THOMAS BENGTSSON and MAUDE WIKSTROM1
Appeal 2016-003356
Application 10/585,867
Technology Center 1600
Before ERIC B. GRIMES, TAWEN CHANG, and
JOHN E. SCHNEIDER, Administrative Patent Judges.
SCHNEIDER, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to a kit
for detecting periodontal disease which have been rejected as obvious. We
have jurisdiction under 35 U.S.C. § 6(b).
We affirm.
STATEMENT OF THE CASE
The present invention is directed to kits for detecting periodontal
disease. Spec. 1. The kit comprises a pair of assays. Spec. 6. The first
assay detects a substance originating from a bacterium and the second assay
1 Appellants identify the Real Party in Interest as Tendera AB. Appeal Br. 3.
Appeal 2016-003356
Application 10/585,867
detects a substance originating from the immune or inflammatory system of
the patient. Id.
Claims 1,2, 11, 17, 18, 42, and 43 are on appeal. Claim 1 is
illustrative and reads as follows:
1. A test kit comprising:
a first detection assay for detecting a first substance
originating from bacteria, wherein the first substance is arg-
gingipain from Porphyromonas gingivalis; and
a second detection assay for detecting a second substance
originating from at least one of an immune and an
inflammatory system of a patient, wherein the second substance
is a natural serine protease.
The claims stand rejected as follows:
Claims 1,2, 11, 17, 18, 42, and 43 stand rejected under 35 U.S.C.
§ 103(a) as unpatentable over Wagner2 in view of Armitage.3
Claims 1,2, 11, 17, 18, 42, and 43 stand rejected under 35 U.S.C.
§ 103(a) as unpatentable over Reynolds4 in view of Singer5 and Chappie.6
2 Wagner et al., WO 02/06820 A3, published Jan. 24, 2002 (“Wagner”).
3 Armitage et al., Longitudinal Evaluation of Elastase as a Marker for the
Progression of Periodontitis, 65 J. Periodontol. 120 (1994) (“Armitage”).
4 Reynolds et al., US 6,511,666 Bl, issued Jan. 28, 2003 (“Reynolds”).
5 Singer, Jr., US 5,376,532, issued Dec. 27, 1994 (“Singer”).
6 Chappie, Periodontal disease diagnosis: current status and future
developments, 25 J. Dentistry 3 (1997) (“Chappie”).
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THE FIRST REJECTION UNDER 35 U.S.C. § 103(a)
Issue
The issue with respect to this rejection is whether the Examiner has
established by a preponderance of the evidence that the pending claims
would have been obvious over Wagner combined with Armitage under
35 U.S.C. § 103(a).
The Examiner finds that Wagner teaches diagnostic test kits for
detecting periodontitis comprising multiple diagnostic assays for both arg-
gingipain and elastase and further teaches that detecting arg-gingipain is a
particularly preferred embodiment. Final Act. 7. The Examiner finds that
Armitage teaches the advantages of using elastase as a marker for the
detection of periodontal disease. Id. The Examiner concludes that
it would have been prima facie obvious to a person of ordinary
skill in the art, at the time the invention was made, to modify a
test kit comprising multiple detection assays for detecting a first
substance originating from bacteria, wherein the first substance
is arg-gingipain from Porphyromonas gingivalis as taught by
[Wagner], by using a second detection assay for detecting a
second substance originating from at least one of an immune
and an inflammatory system of a patient, wherein the second
substance is the natural serine protease, elastase, as taught by
both [Wagner] and Armitage et al., thereby arriving at the
claimed invention, because testing for the arg-gingipain marker
was art-recognized as particularly preferred as taught by
[Wagner] and testing the elastase marker was known to be
advantageous because it was both (1) recognized as producing
fewer false positive results and (2) recognized as best used in
conjunction with other assessments of periodontal disease, as
taught by Armitage et al.
Final Act. 8.
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Application 10/585,867
Appellants contend that Wagner discloses thousands of possible
combinations and that there is no guidance in the references to make the
combination suggested by the Examiner. Appeal Br. 8—9. Appellants argue
that the references teach away from the claimed combination. Appeal Br.
10—11. Appellants also argue that there is evidence of unexpected results
which rebuts the Examiner’s case of obviousness. Appeal Br. 11—12. With
respect to claim 43, Appellants argue that the art does not suggest a “test kit
that consists essentially of tests for the two named proteases,” as claimed.
Appeal Br. 13.
Findings of Fact
We adopt as our own the Examiner’s findings and analysis. The
following findings are included for emphasis and reference convenience.
FF1. Wagner discloses a kit for detecting bacteria which cause
periodontitis. Wagner 1.
FF2. The kit of Wagner can detect enzyme activities which indicate
the presence of periodontitis-producing bacteria. Wagner 8
FF3. Wagner teaches that one of the preferred enzymes which
indicates the presence of bacteria is arg-gingipain. Wagner 8.
FF4. Wagner also teaches that destruction of periodontal tissue can be
detected by looking for the presence of certain enzymes such as elastase.
Wagner 9.
FF5. Wagner teaches looking for one or more markers for
periodontal disease. Wagner 6 (“marker compound” includes substances
indicating mouth disorders), 16 (“one or more enzymes serve as a marker
substance”).
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FF6. Armitage discloses the use of elastase as a marker for
periodontitis. Armitage 120.
FF7. Armitage teaches that “[o]ne of the main strengths of the VES
[visual elastase scores] system, when used to predict the progression of
periodontitis, is the relatively low number of false negatives.” Armitage
125.
FF8. Armitage teaches that
[t]he ability of a positive VES test to identify sites that are at an
increased risk of developing bone loss indicates that is [sic]
may have several useful clinical applications. Such a test might
be helpful in identifying sites that require additional treatment
prior to the maintenance phase of therapy. It may also be
helpful in determining a recall/maintenance interval for treated
patients; for example, those with positive elastase tests may
need more frequent recall visits. As risk assessment tests for
periodontal disease are refined and developed, it is probable
that they will not be used alone, but rather in conjunction with
traditional clinical assessments of periodontal disease.
Armitage 127.
Principles of Law
A proper § 103 analysis requires “a searching comparison of the
claimed invention—including all its limitations—with the teaching of the
prior art.” In re Ochiai, 71 F.3d 1565, 1572 (Fed. Cir. 1995).
Although a reference that teaches away is a significant factor to
be considered in determining unobviousness, the nature of the
teaching is highly relevant, and must be weighed in substance.
A known or obvious composition does not become patentable
simply because it has been described as somewhat inferior to
some other product for the same use.
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In re Gurley, 27 F.3d 551, 553 (Fed. Cir. 1994).
[B]y definition, any superior property must be unexpected to be
considered as evidence of non-obviousness. Thus, in order to
properly evaluate whether a superior property was unexpected,
the [fact-finder] should have considered what properties were
expected. Here, Pfizer’s evidence must fail because the record
is devoid of any evidence of what the skilled artisan would have
expected.
Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1371 (Fed. Cir. 2007).
“[I]t is well settled that unexpected results must be established by
factual evidence. ‘Mere argument or conclusory statements in the
specification does not suffice.’” In re Geisler, 116 F.3d 1465, 1470 (Fed.
Cir. 1997) (quoting In re De Blauwe, 736 F.2d 699, 705 (Fed. Cir. 1994)).
Analysis
Claim 1 is representative of the rejected claims and is directed to a kit
having a first assay which detects arg-gingipain and a second assay which
detects elastase.
We agree with the Examiner that the subject matter of claim 1 would
have been obvious to one skilled in the art at the time the invention was
made. Wagner teaches a kit containing one or more assays for detecting
periodontitis. FF5. Wagner teaches that arg-gingipain is one of the
preferred markers to be detected by the kit. FF3. Wagner also teaches that
the kit can be used to detect other markers such as elastase. FF4 and 5.
Armitage teaches that use of elastase as a marker for periodontitis produces
fewer false negatives than other assays. FF7. We agree with the Examiner
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that a test kit consisting of the two claimed assays would logically flow from
the teachings of the prior art. Ans. 7.
Appellants argue that Wagner discloses thousands of possible
combinations and there is nothing in the references that would lead one
skilled in the art to use two enzymes as markers for periodontitis. Appeal
Br. 7—9; Reply Br. 2—\. We are unpersuaded. Wagner expressly teaches
that arg-gingipain is one of two markers which are derived from a
periodontitis-causing bacterium. FF3. Armitage teaches that elastase
produces fewer false negatives than other markers and that elastase-based
tests “may have several useful clinical applications” including detection of
periodontitis. FF7 and 8. The claimed combination of assays therefore
would have been obvious based on the cited references.
Appellants argue that Armitage teaches away in that Armitage teaches
that a weakness of the VES test is the high incidence of false positives and
also discusses other methods for assessing periodontitis. Appeal Br. 10-11.
We are unpersuaded. As noted above, Armitage specifically states that a test
based on elastase may have useful clinical applications. This would appear
to be opposite of a teaching away. Moreover, that Armitage teaches that
other methods may be used does not constitute a teaching away. In re
Gurley, 27 F.3d at 553.
Although Armitage teaches that “a weakness of the VES test is the
high number of false positives it did record,” it also teaches that other tests
were “unacceptable” because of their high percentages of false negatives.
Armitage 126, left col. Armitage concludes that “the VES test system is a
better method of identifying sites that are at an increased risk of progressing
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than are the GI, PI, probing depth, or bleeding on probing taken singly or in
combination.” Id. at 126, right col. Thus, it does not teach away.
Appellants argue that the claimed method provides unexpected
results, because “all of Armitage’s elastase tests with a sensitivity above
80% have a specificity below 50%, and the elastase tests with a specificity
above 80% all have a sensitivity less than 55%,” while “the combination of
arg-gingipain and elastase as diagnostic markers results in a test with both a
sensitivity (83%) and a specificity (90%) in excess of 80%.” Appeal Br. 12.
However, the Specification merely characterizes its results as showing
that “the combination of elastase and arg-gingipain as a marker for
periodontal disease yields a statistically more significant test than either of
the enzymes alone.” Spec. 21:9-12. Appellants have produced no evidence
to support their position that the results are unexpectedly superior.
Arguments and unsupported statements of unexpected results will not rebut
a prima facie case of obviousness. In re Geisler, 116 F.3d at 1470.
Turning to claim 43, the use of the term “consisting essentially of’
does not render the claimed invention patentable over the prior art. As
discussed above Wagner teaches a kit which may comprise assays for one or
more markers, clearly suggesting a kit containing only two assays. In
addition, Appellants have not shown that the degree of both sensitivity and
specificity achieved by the kit of the invention is unexpected.
Conclusion of Law
We conclude that the Examiner has established by a preponderance of
the evidence that claims 1 and 43 would have been obvious over Wagner
combined with Armitage under 35 U.S.C. § 103(a).
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Claims 2, 11, 17, 18, and 42 have not been argued separately and
therefore fall with claim 1. 37 C.F.R. § 41.37(c)(l)(iv).
THE SECOND REJECTION UNDER 35 U.S.C. § 103(a)
Issue
The issue with respect to this rejection is whether the Examiner has
established by a preponderance of the evidence that the rejected claims
would have been obvious over Reynolds combined with Singer and Chappie.
The Examiner finds that Reynolds teaches kits for detecting
periodontitis including using arg-gingipain as a marker for a bacterium
associated with periodontitis. Final Act. 18. The Examiner finds that
Reynolds teaches that a second marker for periodontitis may be combined
with the arg-gingipain assay. Id. at 19. The Examiner finds that Singer
teaches that detection of just a pathogen associated with periodontitis is
insufficient and that a second biomarker should be used. Id. at 19-20. The
Examiner finds that Singer teaches that elastase is the preferred biomarker.
Id. at 20. The Examiner finds that Chappie teaches methods for detecting
periodontal diseases through the use of two or more assays where one assay
detects a marker indicating the presence of a pathogen and the other detects
a biomarker associated with tissue destruction. Id. The Examiner finds that
among the assays described in Chappie are assays which detect trypsin-like
enzymes from the pathogen and assays which detect elastase. Id. at 21. The
Examiner concludes that
it would have been prima facie obvious to a person of ordinary
skill in the art, at the time the invention was made, to modify a
diagnostic test kit comprising multiple detection assays wherein
a first detection assay comprises arg-gingipain from
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Porphyromonas gingivalis (i.e. a first substance originating
from bacteria) as taught by Reynolds et al., by adding a second
detection assay for detecting a second substance originating
from the immune or inflammatory system of a patient (i.e. a
second substance from a patient) wherein that second marker is
elastase, as taught by both Singer et al. and Chappie, to arrive at
the claimed invention, because it was insufficient and
ineffective to measure biomarkers from only the bacterial
pathogens and elastase was a preferred biomarker derived from
a patient[] at risk of periodontal disease as taught by Singer et
al.
Id. at 21—22.
Appellants contend that there is no reason to combine the references
or to even select the specific references cited by the Examiner. Appeal Br.
13—14. Appellants argue that the references teach away from the claimed
combination and that there is evidence of unexpected results which
overcomes the Examiner’s prima facie case of obviousness. Appeal Br. 14—
15.
Findings of Fact
We adopt as our own the Examiner’s findings and analysis. The
following findings are included for emphasis and reference convenience.
FF9. Reynolds teaches kits for detection of periodontal disease.
Reynolds col. 4,11. 55—63.
FF10. Reynolds teaches using Arg-specific endopeptidases as a
biomarker for periodontal disease. Reynolds col. 6,11. 39-49. See also id. at
col. 21,11. 36-41 (The “Arg-specific endopeptidase component of the PrtR
complex has the same characteristics and N-terminal sequence as the 50 kDa
Arg-specific proteinase . . . designated Arg-gingipain.”).
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FF11. Singer teaches that “[w]hile bacterial pathogens are necessary
for the development of gingivitis and periodontitis, measuring the presence
or absence of specific bacterial pathogens themselves is not a sufficient or
effective means of predicting the likelihood of experiencing active disease.”
Singer col. 2,11. 39-43.
FF12. Singer teaches the use of an assay for periodontal disease
which uses enzymes produced by the patient as biomarkers. Singer col. 8,11.
3AA0.
FF13. Elastase is one of two preferred markers used by Singer. Id.
FF14. Chappie teaches detection of periodontal disease using
enzymes produced by periodontal pathogens and enzymes produced by the
host such as elastase. Chappie 8 and Tables 1 and 2.
FF15. Chappie teaches that “[wjhilst all of the markers discussed
offer greater diagnostic sensitivity and specificity than clinical assessments
currently available, it is likely that combining two or three such markers in a
single chair-side test will provide the most accurate means of diagnosing
ongoing or future disease activity.” Chappie 8.
FF16. Chappie teaches that trypsin-like enzymes and elastase are two
of the enzymes tested used to detect periodontal disease. Chappie 10, Table
2.
Analysis
Claim 1 is representative of the rejected claims and is directed to a kit
having a first assay which detects arg-gingipain and a second assay which
detects elastase.
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We agree with the Examiner that the subject matter of claim 1 would
have been obvious to one skilled in the art at the time the invention was
made. Reynolds teaches the use of an assay for arg-gingipain to detect
periodontal disease. FF9 and 10. Singer teaches that detection of the
presence of a periodontal pathogen alone is insufficient to properly diagnose
periodontal disease. FF11. Singer teaches testing for host derived enzymes
such as elastase to detect periodontal disease. FF12 and 13. Chappie
teaches that using two or three biomarkers will provide the most accurate
means of diagnosing periodontal disease. FF15. We agree with the
Examiner that one skilled in the art would find it obvious to combine the
assay of Reynolds with the assay of Singer to produce a test kit with
improved accuracy. Final Act. 21—22.
Appellants contend that the Examiner has offered no reasons why one
skilled in the art would select the claimed combination over the thousands of
possible combinations in the art. Appeal Br. 13—14. We are unpersuaded.
As the Examiner points out, Chappie teaches that as few as two biomarkers
are needed to improve accuracy and, combined with the teachings of
Reynolds and Singer, provides sufficient guidance to combine the
references. Ans. 25.
Appellants also argue that Chappie teaches away from the claimed
combination. Appeal Br. 14. We are unpersuaded. While Chappie
discusses different diagnostic procedures which can be used to detect
periodontal disease, Chappie states that “[t]he most promising medium for
the collection of valuable diagnostic information is gingival crevicular fluid
(GCF).” Chappie 8. Chappie teaches that assays that test for such enzymes
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as elastase and bacterial trypsin-like enzymes are used to test GCF to detect
periodontal disease. Chappie 8—9, Table 1. Appellants have pointed to
nothing in Chappie which teaches away from using the claimed markers.
Appellants’ arguments with respect to unexpected results and claim
43 are essentially the same as the arguments made with respect to the
rejection based on Wagner and Armitage and have been addressed above.
Conclusion of Law
We conclude that the Examiner has established by a preponderance of
the evidence that claims 1 and 43 would have been obvious over Reynolds
combined with Singer and Chappie under 35 U.S.C. § 103(a).
Claims 2, 11, 17, 18, and 42 have not been argued separately and
therefore fall with claim 1. 37 C.F.R. § 41.37(c)(l)(iv).
SUMMARY
We affirm the rejections under 35 U.S.C. § 103(a).
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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