Ex Parte Holmquist et al

Patent Trial and Appeal Board

May 30, 2018

12964710 (P.T.A.B. May. 30, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO.
12/964,710
109855 7590
Quest Diagnostics
1311 Calle Batido
FILING DATE
12/09/2010
06/01/2018
San Clemente, CA 92673
FIRST NAMED INVENTOR
Brett Holmquist
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.
034827-1051 5251
EXAMINER
GAKH, YELENA G
ART UNIT PAPER NUMBER
1797
NOTIFICATION DATE DELIVERY MODE
06/01/2018 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 BRETT HOLMQUIST and NIGEL CLARK
Appeal2017-004076
Application 12/964,710
Technology Center 1700
Before GEORGE C. BEST, N. WHITNEY WILSON, and
JANEE. INGLESE, Administrative Patent Judges.
WILSON, Administrative Patent Judge.
DECISION ON APPEAL
Appellants 1 appeal under 35 U.S.C. § 134(a) from the Examiner's May 4,
2015 decision finally rejecting claims 1-5, 8-13, 15-21, 24--29, 31--40, 42--45,
47, and 48 ("Final Act."). We have jurisdiction over the appeal under
35 U.S.C. § 6(b).
We affirm.
1 Appellants identify the real party in interest as Quest Diagnostics Investments Inc.
(Br. 1).
Appeal2017-004076
Application 12/964,710
CLAIMED SUBJECT MATTER
Appellants' disclosure is directed to a method for detecting underivatized,
non-metabolized vitamin D by mass spectrometry (Abstract). Details of the
claimed invention may be found in representative claim 1, which is reproduced
below from the Claims Appendix:
1. A method for determining an amount of underivatized
vitamin D2 in a biological sample by tandem mass spectrometry,
the method comprising the steps of:
(i) subjecting the biological sample to [a] turbulent flow
liquid chromatography (TFLC) column;
(ii) ionizing the biological sample under conditions suitable
to generate one or more precursor ions detectable by mass
spectrometry selected from the group consisting of ions with a
mass to charge ratio (m/z) of 397.2 ± 0.5 or 379.2 ± 0.5;
(iii) fragmenting at least one of said precursor ions to
generate one or more fragment ions detectable by mass
spectrometry;
(iv) determining an amount of one or more of the ions
generated in steps (ii) and (iii) by the tandem mass spectrometry;
and
(v) determining the amount of vitamin D2 in the biological
sample by relating the amount of the ions determined in step (iv)
to the amount of vitamin D2 in the biological sample wherein if
the fragmented precursor ions comprise an ion with m/z of 397 .2
± 0.5, the fragment ions comprise one or more ions selected from
the group consisting of ions with m/z of 159.0 ± 0.5, 146.9 ± 0.5,
13 3 .1±0.5, and 121. 0 ± 0. 5, and if the fragmented precursor ions
comprise an ion with m/z of 379.2 ± 0.5, the fragment ions
comprise one or more ions selected from the group consisting of
ions with m/z of 283.2 ± 0.5, 187.3 ± 0.5, 175.2 ± 0.5, and 159.0 ±
0.5.
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Appeal2017-004076
Application 12/964,710
REJECTIONS
Claims 1-5, 8-13, 15-21, 24--29, 31--40, 42--45, 47, and 48 are rejected
under 35 U.S.C. § 103(a) as unpatentable over Capote2 in view of Zimmer3 or
Bunch. 4 The Examiner withdrew the rejections set forth in the Final Action
under 35 U.S.C. § 112, first and second paragraphs (Ans. 4). Thus, the§ 112
rejections are not before us.
DISCUSSION
Appellants do not advance separate arguments in support of the
patentability of any of the dependent claims (see, Appeal Br. 10-11 ).
Accordingly, we focus our analysis on the rejection of claim 1 over Capote
in view of Zimmer or Bunch.
The Examiner finds that Capote discloses each element of claim 1,
except that Capote does not teach the use of turbulent flow liquid
chromatography as the first step before performing the LC-MS analysis of
steps (ii)-(v) (Final Act. 7-8). However, the Examiner finds that Capote
teaches that most of the known methods for simultaneous determination of
2 Feliciano Priego Capote et al., Identification and determination of fat-
soluble vitamins and metabolites in human serum by liquid
chromatography/triple quadrupole mass spectrometry with multiple reaction
monitoring, 21 Rapid Commun. Mass. Spectrom. 17 45-17 54 (2007).
3 Dieter Zimmer et al., Comparison of turbulent-flow chromatography with
automated solid-phase extraction in 96-well plates and liquid-liquid
extraction used as plasma sample preparation techniques for liquid
chromatography-tandem mass spectrometry, 854 J. Chromatogr. A, 23-35
(1999).
4 Dustin R. Bunch et al., Development and validation of a liquid
chromatography-tandem mass spectrometry assay for serum 25-
hydroxyvitamin D2/D3 using a turbulent flow online extraction technology,
47 Clin. Chem. Lab. Med. 1565-1572 (2009).
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Appeal2017-004076
Application 12/964,710
fat-soluble vitamins (like vitamins D2 and D3) have "an extraction step prior
to [the] liquid chromatographic analysis," and that Capote teaches liquid-
liquid extraction as a preconcentration step (Final Act. 8). The Examiner
further finds that both Zimmer and Bunch teach that turbulent flow liquid
chromatography can be used in place of solid-phase extraction or in advance
of liquid chromatography-tandem mass spectroscopy assay for serum 25-
hydroxyvitamin D2/D3 (id.).
The Examiner determines that it would have been obvious to apply
the advanced turbulent flow online extraction techniques taught by Zimmer
or Bunch in Capote's method because the secondary references specifically
recite advantages of substituting turbulent flow on-line extraction for liquid-
liquid or solid-phase extraction steps for purifying biological samples (id.).
Appellants argue that Capote teaches using reverse phase liquid
chromatography followed by mass spectrometry, while Bunch discloses
replacing high performance liquid chromatography with turbulent flow
liquid chromatography (Br. 11 ). Appellants further argue that neither Bunch
nor Capote nor Zimmer suggest that reverse phase liquid chromatography
should be replaced with turbulent flow liquid chromatography (id.).
This argument is not persuasive. The Examiner finds that Capote
teaches liquid-liquid extraction as a preconcentration and cleanup step of the
sample comprising D2 and D3 vitamins before performing the LC-MS
analysis (Ans. 4, citing Capote 1746, right column), and both Zimmer and
Bunch teach advantages of turbulent flow liquid chromatography compared
to liquid-liquid extraction. Appellants do not persuasively demonstrate error
in these findings. Moreover, the Examiner has explained why a person of
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Application 12/964,710
skill in the art would have combined turbulent flow liquid chromatography
from Zimmer or Bunch into Capote's method (Final Act. 8).
Finally, Appellants argue that neither Zimmer nor Bunch teach that
turbulent flow liquid chromatography can be used in connection with
underivatized nutritional vitamin D quantitation (Br. 11 ). However, this
argument is based on the individual teachings of the references, not their
combined teachings. Attacking references individually where, as here, the
rejections are based on a combination of references is ineffectual in arguing
against an obviousness rejection. In re Keller, 642 F.2d 413, 426 (CCPA
1981 ).
Accordingly, Appellants have not demonstrated reversible error in the
obviousness rejection.
CONCLUSION
We AFFIRM the rejection of claims 1-5, 8-13, 15-21, 24--29, 31--40,
42--45, 47, and 48 under 35 U.S.C. § 103(a) as unpatentable over Capote in
view of Zimmer or Bunch.
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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