Ex Parte Seiple

Patent Trial and Appeal Board

Dec 29, 2016

13252693 (P.T.A.B. Dec. 29, 2016)

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.
13/252,693 10/04/2011 Lauren Amy Seiple 2011P20681US 4896
28524 7590 01/03/2017
SIEMENS CORPORATION
INTELLECTUAL PROPERTY DEPARTMENT
3501 Quadrangle Blvd Ste 230
EXAMINER
GERIDO, DWAN A
Orlando, EL 32817 ART UNIT PAPER NUMBER
1797
NOTIFICATION DATE DELIVERY MODE
01/03/2017 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):
ipdadmin.us@siemens.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte LAUREN AMY SEIPLE
Appeal 2015-006557
Application 13/252,693
Technology Center 1700
Before LINDA M. GAUDETTE, N. WHITNEY WILSON, and
JENNIFER R. GUPTA, Administrative Patent Judges.
GUPTA, Administrative Patent Judge.
DECISION ON APPEAL1
Appellant2 appeals under 35 U.S.C. § 134(a) from the Examiner’s
decision finally rejecting claims 1—20. We have jurisdiction under
35 U.S.C. § 6(b).
We AFFIRM-IN-PART and enter a NEW GROUND OF
REJECTION pursuant to 37 C.F.R. § 41.50(b).
1 In this decision, we refer to the Final Office Action mailed June 19, 2016
(“Final Act.”), the Appeal Brief filed December 10, 2014 (“App. Br.”), the
Examiner’s Answer mailed May 4, 2015 (“Ans.”), and the Reply Brief filed
June 24, 2015 (“Reply Br.”).
2 Appellant identifies the real party in interest as Dade Behring Marburg
GmbH, which is a wholly owned subsidiary of Siemens Healthcare
Diagnostics. App. Br. 2.
Appeal 2015-006557
Application 13/252,693
The subject matter on appeal relates to methods of reducing the effect
of interfering substances on measurements conducted during methods for
determining the concentration of an analyte in a sample. Spec. 11. Claims 1
and 15, reproduced below, are illustrative of the claims on appeal.
1. A method for correcting an assay measurement for
determining a concentration of an analyte in a sample suspected
of containing the analyte, the method consisting of:
(a) measuring assay signal at a first wavelength
corresponding to the analyte in the sample,
(b) measuring assay signal at a second wavelength
corresponding to background and multiplying by a correction
factor, wherein the correction factor is predetermined and
corrects for the presence of lipemic interfering substances in the
sample,
(c) subtracting (b) from (a) to determine an assay signal
value, and
(d) relating the assay signal value to the concentration of
analyte in the sample.
15. A method for mitigating lipid interference with a
measurement in an assay for a metal ion in a blood sample, wherein a
signal is read at a first wavelength and at a second wavelength, the
method consisting of:
(a) determining a correction factor for signal read at the second
wavelength wherein the correction factor corrects for the presence of
lipemic interfering substances in the blood sample, and
(b) subtracting signal read at the second wavelength times the
correction factor from signal read at the first wavelength to obtain a
measurement result.
App. Br. (Claims Appendix) 20, and 23.
Independent claim 7 is directed to a method for determining one or
both of a presence and an amount of lithium ion in a sample suspected of
containing lithium ion. The method includes steps similar to steps (a) and
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(b) in claim 1: “(c) measuring an assay signal at a first wavelength
corresponding to the lithium ion in the sample” and “(d) measuring assay
signal at a second wavelength corresponding to background and multiplying
by a correction factor.” .
REJECTIONS ON APPEAL3
1. Claims 15—20 stand rejected under 35 U.S.C. § 101;
2. Claims 1, 4—10, and 12—19 stand rejected under pre-AIA 35 U.S.C.
§ 103(a) as unpatentable over Luther et al. (US 2006/0033920 Al,
published Feb. 16, 2006) (hereinafter “Luther”) in view of Czech
et al. (US 5,187,103, issued Feb. 16, 1993) (hereinafter “Czech”);
and
3. Claims 2, 3, 11, and 20 stand rejected under pre-AIA
35 U.S.C. § 103(a) as unpatentable over Luther in view of Czech,
and further in view of Lo et al. (US 4,627,014, issued Dec. 2 1986)
(hereinafter “Lo”).
DISCUSSION
Rejection 1
The method of claim 15 includes two steps: a step (a) of determining a
correction factor for signal read at the second wavelength, and a step (b) of
subtracting signal read at the second wavelength times the correction factor
from signal read at the first wavelength to obtain a measurement result.
3 The rejection of claims 2, 3, 11, 16, and 20 under 35 U.S.C. § 112, second
paragraph, on pages 2—3 of the Final Office Action was withdrawn in the
Examiner’s Answer. Ans. 6.
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Application 13/252,693
The Examiner contends that “the determining and subtracting steps [in
claim 15] are purely mental processes that can be performed by a person and
therefore is not patent eligible subject matter.” Final Act. 2.
The Supreme Court set forth a framework for determining whether
claims are directed to patent-eligible subject matter in Alice Corp., Pty. Ltd.
v. CLSBankInt’l, 134 S.Ct. 2347, 2355 (2014) (citingMayo Collaborative
Servs. v. Prometheus Labs., Inc., 132 S.Ct. 1289 (2012)). First, we must
determine whether the claims at issue are directed to a law of nature, a
natural phenomena, or an abstract idea. Id. If the answer is yes, we then
consider, “[w]hat else is there in the claims before us?” Id. To answer the
second question, we “consider the elements of each claim both individually
and ‘as an ordered combination’ to determine whether the additional
elements ‘transform the nature of the claim’ into a patent-eligible
application.” Id. The Supreme Court described step two of the analysis as a
search for an “inventive concept”—i.e., “[an] element or combination of
elements that is ‘sufficient to ensure that the patent in practice amounts to
significantly more than a patent upon the [ineligible concept] itself.’” Id.;
see also Mayo, 111 F.3d at 1286 (stating that a court must first “identif[y]
the abstract idea represented in the claim,” and then determine “whether the
balance of the claim adds ‘significantly more.’”).
As the Examiner points out, the determining and subtracting steps in
claim 15 can be performed by human thought and thus are abstract ideas.
CyberSource Corp. v. Retail Decisions, Inc., 654 F.3d 1366, 1373 (Fed. Cir.
2011) (A method that can be performed by human thought alone is merely
an abstract idea and is not patent-eligible under 35 U.S.C. § 101.).
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“The ‘abstract ideas’ category embodies ‘the longstanding rule that
“[a]n idea of itself is not patentable.”’ Gottschalk v. Benson, 409 U.S. 63,
67 (1972) (quoting Rubber—Tip Pencil Co. v. Howard, 87 U.S. 498, 507
(1874)). A method that can be performed by human thought alone is merely
an abstract idea and is not patent-eligible under 35 U.S.C. § 101.
CyberSource, 654 F.3d at 1373. This is because “computational methods
which can be performed entirely in the human mind are the types of methods
that embody the ‘basic tools of scientific and technological work’ that are
free to all men and reserved exclusively to none.” Id.
Appellant argues that in addition to the “determining” and
“subtracting steps,” the preamble of claim 15 requires reading a signal for
assay at a second wavelength, which in turn is used in step (a) for
determining a correction factor, and this additional step is “sufficient to
render the claim more than just purely a mental process.” Reply Br. 6.
“In general, a preamble limits the invention if it recites essential
structure or steps, or if it is ‘necessary to give life, meaning, and vitality’ to
the claim.” Catalina Mktg. Int’l., Inc. v. Coolsavings.com, Inc., 289 F.3d
801, 808 (Fed. Cir. 2002) (quoting Pitney Bowes, Inc. v. Hewlett-Packard
Co., 182 F.3d 1298, 1305 (Fed. Cir. 1999)). The court in Catalina noted
that although no litmus test exists for determining whether to treat a
preamble as a limitation, several “guideposts” have emerged from the case
law in this area. Id. In particular, guideposts tending to show that the
preamble is a claim limitation include: Jepson claiming, dependence on a
particular disputed preamble phrase for antecedent basis, when the preamble
is essential to understand limitations or terms in the claim body, and when
the preamble recites additional structure or steps underscored as important
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by the specification. Id. On the other hand, the preamble might not
constitute a claim limitation when the claim body describes such a
structurally complete invention that deleting the preamble phrase does not
affect the structure or steps of the claimed invention. Id.
Applying the standard in Catalina, we are persuaded that the
preamble further limits claim 15. Step (a) of claim 15 relies on the preamble
for antecedent basis for the “signal read at the second wavelength.” Because
the Appellant chose to use both the preamble and the body of the claim to
define the subject matter of the claimed invention, the preamble is limiting.
See e.g., C.W. Zumbiel Co., Inc. v. Kappos, 702 F.3d 1371, 1385 (Fed. Cir.
2012); Eicon, Inc. v. Straumann Co., 441 F.3d 945, 952-53 (Fed. Cir. 2006)
(“when the limitations in the body of the claim ‘rely upon and derive
antecedent basis from the preamble, then the preamble may act as a
necessary component of the claimed invention”’ (citations omitted)).
Although the preamble limits claim 15, as Appellant argues, as the
Examiner points out, “the steps of reading and/or analyzing a signal from a
sample at different wavelengths is routine and conventional activity
commonly practiced in the prior art,” as evidenced by Luther. Ans. 7; see
also Spec. 2—3. Pre- or post-solution activities that are “purely
‘conventional or obvious,\..‘can[not] transform an unpatentable principle
into a patentable process.”’ Mayo, 132 S.Ct. at 1298—99 (citing Parker v.
Flook, 437 U.S. 584, 589-90 (1978)). Thus, the additional preamble
limitation, alone or in combination with steps (a) and (b) in claim 15, does
not transform the method of claim 15 into a patent eligible process.
In view of the foregoing, we find no reversible error in the Examiner’s
determination that the subject matter recited in claim 15 under
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35 U.S.C. §101 is unpatentable as being directed to non-statutory subject
matter. Thus, we sustain the rejection.
Rejections 2 and 3
The Examiner relies on the same teachings in Luther and Czech in
Rejections 2 and 3.
The Examiner finds Luther teaches all the recitations of the method of
independent claims 1, 7, and 15 except multiplying a second wavelength by
a correction factor that “corrects for the presence of lipemic interfering
substances” and relating the assay signal value to the concentration of
analyte (claim 1) or lithium ion (claim 7) in a sample. Ans. 7—8; Final
Act. 4, citing Luther || 25, 61, 62, and 66. The Examiner finds Czech
teaches a method for determining the concentration of lithium in a blood
sample by adding a chromogenic diazocryptand to the sample, and
measuring the absorbance of the sample. Final Act. 4 (citing Czech 1:14—
21, 3:22—25, and Fig. 2). The Examiner finds that Czech teaches lipids as an
interfering substance in human serum samples requiring blank correction.
Final Act, citing Czech 14:7—10. The Examiner finds that one of ordinary
skill in the art would have been motivated to modify Luther, based on
Czech, to determine lithium concentration in order to monitor lithium drug
therapy with a rapid and easy to use method as taught by Czech. Final
Act. 2.
Appellant contends the Examiner’s rejection of claims 1, 7, and 15 is
based on improper hindsight reasoning. Specifically, Appellant argues that
“Luther does not disclose or suggest that the correction factor corrects for
the presence of lipemic interfering substances in the sample,” and thus,
absent hindsight reasoning based on Appellant’s own disclosure, “[tjhere is
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nothing in the teaching of Czech or in Luther that would [have] suggest [ed]
to one of ordinary skill in the art that the adsorption detection system of
Luther would or could require blank correction for lipemic samples.” App.
Br. 11, and 12.
The Examiner bears the initial burden of presenting a prima facie case
of obviousness. In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992).
“[RJejections 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.” In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006) (quoted with
approval in KSRInt’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007)). Based
on this record, we are persuaded by Appellant’s argument that the Examiner
has not met the burden in this case. The Examiner fails to provide a
persuasive reason with some rational underpinning for why one of ordinary
skill in the art would have looked to Czech’s method for determining the
presence and concentration of a lithium ion in blood samples to aid
physicians in monitoring lithium drug therapy (Czech 1:13—21) to modify
Futher’s method for analyzing tissue or cellular samples stained with
chromatic fluorescent or other dyes (Futher 12). See Final Act. 4; see also
Ans. 7—8. Thus, we cannot sustain he Examiner’s obviousness rejections of
claims 1—20.
New Ground of Rejection
Pursuant to 37 C.F.R. § 41.50(b), we enter a new ground of rejection
only for claims 1, 7, and 15 under 35 U.S.C. § 103(a) as unpatentable over
Czech in view of Fo.
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Czech teaches a method for measuring the concentration of an analyte
(lithium ions) in a blood sample using a new chromogenic cryptand that
complexes selectivity to lithium ions and is capable of exhibiting a
detectable response which is a function of the presence of the lithium ion in
the sample. Czech 3:22—25, 3:45—4:7, and 5:33—45. Czech teaches that
lipemic substances in human serum samples cause interference and could
require correction. Id. at 14:7—10.
Lo teaches a method for using an apparatus, such as a chemical
analyzer, to determine concentration of analytes, such as bilirubin, in human
sera, and to methods for calibrating the apparatus to correct for the presence
of interferents. Lo 1:6—16. Lo teaches that its calibration procedure
“provides a means for overcoming the effect of undefined interferents in the
determination of an analyte.” Id. at 2:61—67.
According to Lo, the apparatus is calibrated by conducting assays for
analyte concentration and identifying two patient test samples having the
same analyte concentration, where the first patient sample has a known
amount of an interferent effect (% of bias of greater than 50%) (“biased”
sample) and the second patient test sample does not have a significant bias
(“unbiased” sample). Id. at 3:20-37, 9:10-39, and 14:15—23. A spectral
scan is then made of each of the patient test samples at a first wavelength
and a second wavelength, where the absorption wavelength at the second
wavelength is used to correct the absorption result obtained at the first
wavelength for interferent effects. Id. at 3:38-47, 9:40-10:8, and 14:23—40.
Lo teaches using human serum samples of known analyte
concentrations to perform a linear regression analysis and determine a
constant (correction factor). Id. at 3:48—68, 10:9-49. Lo teaches
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multiplying a signal at a second wavelength used to correct interferent
effects by the correction factor, subtracting this product from the signal
measured for a sample at the first wavelength corresponding to analyte in the
sample to determine the corrected signal for the sample, and relating this
corrected signal to a concentration of the analyte in the sample. Id. at 3: lb-
28, 4:1-2, 9:1-10, 9:67-10:8, 10:39-52, and 14:41-15:1. Thus, Lo’s
calibration method reduces the bias observed with the known assay and
significantly improves the accuracy of the concentration determination. Id.
at 15:21-24.
In assessing the obviousness of the subject matter recited in the claims
on appeal, “[ojften, it will be necessary for... [us] to look to interrelated
teachings of [the] multiple [prior art references] ... in order to determine
whether there was an apparent reason to combine the known elements in the
fashion claimed....” KSR, 550 U.S. at 418 . These prior art references must
be read in context, taking into account “demands known to the design
community,” “the background knowledge possessed by a person having
ordinary skill in the art,” and “the inferences and creative steps that a person
of ordinary skill in the art would employ.” Id. The background knowledge
attributable to one of ordinary skill in the art includes what was admittedly
known in the art at the time of the invention. In re Nomiya, 509 F.2d 566,
570-71 (CCPA 1975) (The admitted prior art in applicant’s specification
may be used in determining the patentability of a claimed invention.).
Because there is a desire to correct for interferent effects in human
sera, as taught in Czech (Czech 14:7—10) and Lo (Lo 2:61—67), and
Appellant’s Specification (Spec. 12—3), one of ordinary skill would have
been motivated to use Lo’s calibration method to correct samples with
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lipemic interfering effects, as taught by Czech, with a reasonable expectation
that it would provide a successful method for a more accurate determination
of the lithium ion concentration in Czech’s method. Thus, we conclude that
the method of claims 1, 7, and 15 would have been obvious over Lo in view
of Czech.
We enter the new ground only for independent claims 1, 7, and 15,
and leave to the Examiner the evaluation of the patentability of dependent
claims 2—6, 8—14, and 16—20.
DECISION
For the reasons set forth above, we affirm the rejection of claims 15—
20 under 35 U.S.C. § 101. We reverse the rejections under 35 U.S.C. §
103(a) of claims 1, 4—10, and 12—19 over Luther and Czech, and claims 2, 3,
11, and 20 over Luther in view of Czech and Lo. We enter a new ground of
rejection under 35 U.S.C. § 103(a) of claims 1, 7, and 15 over Czech and Lo.
This decision contains a new ground of rejection pursuant to
37 C.F.R. § 41.50(b). Section 41.50(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
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
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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.
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-fN-P ART;
NEW GROUND OF REJECTION
PURSUANT TO 37 C.F.R, $ 41.50(b)
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