Ex Parte Yang et al

Patent Trial and Appeal Board

Dec 26, 2018

14534661 (P.T.A.B. Dec. 26, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO.
14/534,661
109855 7590
Quest Diagnostics
1311 Calle Batido
FILING DATE
11/06/2014
12/28/2018
San Clemente, CA 92673
FIRST NAMED INVENTOR
Changming Yang
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.
034827-0358 1084
EXAMINER
SMITH, DAVIDE
ART UNIT PAPER NUMBER
2881
NOTIFICATION DATE DELIVERY MODE
12/28/2018 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):
ipdocketing@foley.com
joshua.e.kim@questdiagnostics.com
joel.s.white@questdiagnostics.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte CHANGMING YANG and SUM CHAN1
Appeal2017-010598
Application 14/534,661
Technology Center 2800
Before MARK NAGUMO, MICHAEL P. COLAIANNI, and
MICHAEL G. McMANUS, Administrative Patent Judges.
COLAIANNI, Administrative Patent Judge.
DECISION ON APPEAL
1The real party in interest is identified as Quest Diagnostic Investments Inc.,
App. Br. 1.
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Application 14/534,661
Appellants appeal under 35 U.S.C. § 134 the final rejection of claims
1-3, 5-15, and 17-24. We have jurisdiction over the appeal pursuant to
35 U.S.C. § 6(b).
We AFFIRM.
Appellants' invention is directed to methods for quantitative
measurement of vitamin B2 by HPLC-tandem mass spectrometry. (Spec.
,r 2, claim 1 ).
Claim 1 is illustrative:
1. A method for determining the amount of vitamin B2 in a
biological sample from a human, said method comprising:
(a) adding an internal standard to the sample;
(b) subjecting the sample to liquid chromatography;
( c) ionizing vitamin B2 and the internal standard under conditions
suitable to produce one or more ions detectable by tandem mass
spectrometry, wherein said one or more ions comprise one or more ions
selected from the group consisting of ions with a mass to charge ratio of
377.2 ±0.5 and 243.2 + 0.5;
( d) determining the amount of said one or more ions by tandem
mass spectrometry; and
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( e) comparing the amount of said one or more ions of vitamin B2 and said
one or more ions of the internal standard to determine the amount of vitamin
B2 in the sample.
Appellants appeal the following rejections:
1. Claims 1-3, 6-11, 13-15, 18-22, and 24 are rejected under 35 U.S.C.
§ 103 as unpatentable over 0. Midttun et al. (Multianalyte
Quantification of Vitamin B6 and B2 Species in the Nanomolar Range
in Human Plasma by Liquid Chromatography-Tandem Mass
Spectrometry 2005) in view of P. Chen et al. (LC/UV /MS-MRM for
the simultaneous determination of water-soluble vitamins in multi-
vitamin dietary supplements 2006).
2. Claims 5 and 17 are rejected under 35 U.S.C. § 103 as unpatentable
over Midttun in view of Chen and Huang (US 2009/0203145 Al;
published Aug. 13, 2009).
3. Claims 12 and 23 are rejected under 35 U.S.C. § 103 as unpatentable
over Midttun in view of Chen and Ritchie et al. (US 2009/0127454
Al; published May 21, 2009).
Appellants argue the rejections together (App. Br. 7-8). We select claim
1 as representative. All claims not argued separately will stand or fall with
our analysis of the rejection of claim 1.
FINDINGS OF FACT & ANALYSIS
The Examiner's rejection of claim 1 is located on pages 2 to 3 of the
Answer.
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Application 14/534,661
Appellants do not dispute the Examiner's reason for combining
Chen's teaching of a typical mass to charge ratio for riboflavin in mass
spectrometry with Midttun's mass spectrometry of vitamin B2 (i.e.,
riboflavin) (App. Br. 7). Appellants do not put forth any particular
arguments attacking the Examiner's prima facie case of obviousness.
Rather, Appellants contend that the Examiner erred in assessing the merits
of Appellants' allegation and evidence of superior results (App. Br. 7).
Appellants argue that the lower limit of quantification (LLOQ) of vitamin
B2 for their method is 5 nMol/L whereas the LLOQ of riboflavin for Chen is
53 nMol/L (App. Br. 7). Appellants contend that a ten-fold increase in
vitamin B2 sensitivity detection is significantly superior and unexpected
(App. Br. 7).
The Examiner finds that Appellants' comparison of the data in the
Specification with the data in Chen is not probative of non-obviousness
because Midttun is the primary reference (Ans. 6-7). In other words, the
Examiner finds that Appellants have not compared the claimed invention
with the closest prior art. We agree. To be probative of non-obviousness
evidence of unexpected results must be compared to the closest prior art. In
re Burckel, 592 F.2d 1175 (CCPA 1979). In this case, Midttun is the
closest prior art because it teaches most of the limitations of claim 1. Indeed,
Midttun teaches detecting riboflavin (vitamin B2) levels to around 10.3
nMol/L (Midttun 1206). This value falls within the range ofLLOQ values
recited in dependent claim 8 (i.e., 5 nMol/L to 25 nMol/L). Moreover,
Midttun 1213, Table 2 reports LOD for RF (riboflavin) of 0.2 nmol/L, and at
1214, Table 4, reports a riboflavin range of 4.9-38.4 nmol/L measured in
healthy persons. The Examiner correctly states "there is no evidence that the
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Application 14/534,661
current invention produces a greater analytical sensitivity than the primary
reference, Midttun" (Ans.
6-7).
Appellants' apparent position is that the method steps of claim 1
should be limited to producing a LLOQ sensitivity for vitamin B2 of 5
nMol/L. However, claim 8 depends from claim 1 and recites a range of
LLOQ from 5 nMol/L to 25 nMol/L. Under 35 U.S.C. § 112 and the
doctrine of claim differentiation, claim 1 cannot be read as limited solely to
yielding a LLOQ of 5 nMol/L for vitamin B2. If claim 1 were read as
Appellants argue then claim 8 would not further limit claim 1. In other
words, the LLOQs achieved by claim 1 must be broader than claim 8 and
include LLOQ values other than 5 nMol/L for vitamin B2.
Patentability must be based on limitations recited in the claims. See,
In re Self, 671 F.2d 1344, 1348 (CCPA 1982) ("Many of appellant's
arguments fail from the outset because . . . they are not based on limitations
appearing in the claims."). Appellants have not directed us to what
limitations in the claim are response for the allegedly unexpected results.
Moreover, Example 5 of the Specification tests blood plasma and human
serum samples (Spec. ,r,r 84, 97). The source of the samples in claim 1 is not
limited to human serum and may include blood, saliva, cerebrospinal fluid or
tissue samples (Spec. ,r 84). Appellants have not shown that claim 1 yields a
LLOQ sensitivity of 5 nMol/L for the entire range of human sample types
disclosed and falling within the recited "sample from a human" in claim 1.
In other words, Appellants' evidence in Example 5 is not commensurate in
scope with the claim.
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On this record, the totality of evidence supports the Examiner's
conclusion that the subject matter of claim 1 would have been obvious over
the combined teachings of Midttun and Chen. We affirm the Examiner's
§ 103 rejections (1) to (3).
DECISION
The Examiner's decision is affirmed.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R. §
41.50 (f).
ORDER
AFFIRMED
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