Ex Parte Holmquist et al

Patent Trial and Appeal Board

Apr 21, 2016

12964717 (P.T.A.B. Apr. 21, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO.
12/964,717
109855 7590
Quest Diagnostics
1311 Calle Batido
FILING DATE
12/09/2010
04/25/2016
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.
034827-1021 5269
EXAMINER
SODERQUIST, ARLEN
ART UNIT PAPER NUMBER
1797
NOTIFICATION DATE DELIVERY MODE
04/25/2016 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 CLARKE
Appeal2014-004789
Application 12/964,717
Technology Center 1700
Before ADRIENE LEPIANE HANLON, JEFFREY T. SMITH, and
MICHELLE N. ANKENBRAND, Administrative Patent Judges.
ANKENBRAND, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Appellants 1 appeal under 35 U.S.C. § 134(a) from the Examiner's
rejection of claims 1--44. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm.
The Invention
Appellants' invention relates to methods for detecting derivatized
vitamin D by mass spectroscopy. Spec. Abstract. Claim 1 is representative
of the claims on appeal, and is reproduced below from the Claims Appendix
1 Appellants identify Quest Diagnostics Investments Incorporated as the real
party in interest. Id. at 1.
Appeal2014-004789
Application 12/964,717
to the Appeal Brief:
1. A method for detennining the amount of non-
rnetabolized vitamin D in a sample by tandem rnass
spectrometry, the rnethod comprising the steps of
(i) subjecting Cookson-type-derivatized non-metabolized
vitamin D from the sample to an ionization source to generate
one or more precursor ions detectable by mass spectrometry;
(ii) fragmenting at least one of said precursor ions to generate
one or more fragment ions detectable by mass spectrometry;
(iii) determining the amount of one or more precursor and
fragment ions by mass spectrometry; and
(iv) relating the amount of ions determined in step (iii) to the
amount of a non-metabolized vitamin Din the sample,
wherein the sample is subjected to a Cookson-type
derivatization reagent under conditions sufficient to generate
Cookson-type-derivatized non-metabolized vitamin D prior to
step (1).
App. Br. 13 (Claims App'x).
The References
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. CHROMATOGRAPHY A
23, 23-3 5 ( 1999) ("Zimmer").
Naoaki Murao et al., Ferrocene-based Diels-Alder derivatization for
the determination of 1 a-hydroxyvitamin DJ in rat plasma by high-
performance liquid chromatography-electrospray tandem mass
spectrometry, 346 ANALYTICAL BIOCHEMISTRY 158, 161-163 (2005)
("Murao").
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
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Application 12/964,717
monitoring, 21 RAPID COMM. ivIASS SPECTROMETRY 17 45, 17 45-17 54
(2007) ("Capote").
Pavel A. Aronov et al., Metabolic profiling of major vitamin D
metabolites using Diels-Alder derivatization and ultra-performance liquid
chromatography-tandem mass spectrometry, 391 ANALYTICAL
BIOANALYTICALCHEMISTRY 1917, 1917-1930 (2008) ("Aronov").
The Rejections
1. Claims 1 and 7-23 are rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Aronov and Capote;
2. Claims 2, 3, 5, and 6 are rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Aronov, Capote, and Murao; and
3. Claims 4 and 24--44 are rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Aronov, Capote, and Zimmer or the
combination of Aronov, Capote, Murao, and Zimmer.
OPINION
After having considered each of Appellants' contentions and the
evidence presented in this Appeal, we determine that Appellants have not
identified reversible error in the Examiner's rejections of claims 1--44 under
35 U.S.C. § 103. Thus, we affirm these rejections for the reasons expressed
in the Final Action, Answer, and below.
Rejection 1
Appellants argue the claims as a group. See App. Br. 8-11.
Therefore, we limit our discussion to representative claim 1. Claims 7-23
stand or fall with claim 1. See 37 C.F.R. § 41.37(c)(l)(iv) (2013).
Appellants argue that Aronov teaches away from measuring non-
metabolized vitamin D with a mass spectrometry-based quantitation method.
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App. Br. 8-10. In particular, Appellants point to a portion of Aronov, which
discloses that the authors omitted derivatized non-metabolized vitamin D
from the method because they obtained poor recoveries of the non-
metabolized vitamin D. Id. at 9-10. Appellants contend that the omission
reflects Aronov' s "conviction that the methods tested in the article were not
suitable for measurement of non-metabolized vitamin D." Id. at 10.
We are not persuaded. "A reference may be said to teach away when
a person of ordinary skill, upon reading the reference, would be discouraged
from following the path set out in the reference, or would be led in a
direction divergent from the path that was taken by the applicant." In re
Gurley, 27 F.3d 551, 553 (Fed. Cir. 1994). As the Examiner points out,
Aronov focuses on the metabolites rather than non-metabolized vitamin D,
but does not teach that it was or would have been impossible to
quantitatively measure non-metabolized vitamin D. Ans. 6, 9. Indeed,
Aronov discloses that non-metabolized vitamin Dis recovered from the
extraction step of the method, albeit to a much lesser extent than more polar
forms of vitamin D. Aronov 1925. Aronov further teaches that derivatized
non-metabolized vitamin Dis detectable with tandem mass spectrometry, as
Table 1 illustrates that both precursor and product ions are formed for
derivatized non-metabolized vitamin D2 and D3. Id. at 1920, Table 1. And
Aronov explains that although usually it is not necessary to analyze blood
levels of vitamin D2 and D3 (i.e., non-metabolized vitamin D), such a need
exists in supplementation studies. Id. at 1918. Thus, Aronov expresses a
preference for using the described method to profile derivatized metabolites,
but would not have discouraged the skilled artisan from using the method to
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Application 12/964,717
profile derivatized non-metabolized vitamin D, e.g., for supplementation
studies.
Appellants argue that Capote would not have provided one of ordinary
skill in the art with a reason to use Aronov's method to profile non-
metabolized vitamin D because Capote's teachings are focused on vitamin D
metabolites and Capote "discloses nothing regarding how to achieve
measurement of non-metabolized vitamin D." App. Br. 10-11. In this same
regard, Appellants argue that the Examiner's rationale for combining the
prior art teachings amounts to impermissible hindsight. Id. at 11.
We are not persuaded, as the method described in Capote is directed
to identifying and determining "fat-soluble vitamins Ki, K3, A, D2, D3 and E
... and metabolites 25-hydroxyvitamin D2 and D3 and 1,25-
dihydroxyvitamin D3 in human serum by liquid
chromatography/electrospray ionization tandem mass spectrometry."
Capote 1745 (Abstract). Capote's method, therefore, focuses on both
metabolized and non-metabolized vitamin D. Further, as the Examiner
finds, Capote explains that the measurement of both vitamin D metabolites,
"as well as the non-hydroxylated [i.e., non-metabolized] forms is important
to ascertain vitamin D status." Id.; Final Act. 3--4. To that end, Capote
discloses identification and quantification methods and data-including
chromatograms, limit of detection data, and limit of quantification data-for
non-metabolized vitamin D2 and D3. See Capote Figs. 1-5, Tables 2--4.
Appellants' argument that Capote "is all about metabolized vitamin D,"
therefore, is without merit.
We also find Appellants' hindsight argument without merit. If the
Examiner articulates reasoning having rational underpinnings for making a
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proposed modification or combination of prior art teachings, then that
articulated reasoning demonstrates the combination is not based on
impermissible hindsight. See In re Kahn, 441 F.3d 977, 988 (Fed. Cir.
2006). Here, the Examiner finds that it would have been obvious to measure
non-metabolized vitamin Dusing Aronov's method, given Capote's
teachings that measuring the non-metabolized forms is important to ascertain
vitamin D status and having a complete profile is of great interest in clinical
practice and metabolomics. Final Act. 4. Based on our foregoing discussion
of Aronov and Capote, we are persuaded that the Examiner's articulated
reasons for combining the teachings support the conclusion of obviousness.
Accordingly, we affirm the rejection of claims 1 and 7-23 under 35 U.S.C. §
103.
Re} ections 2 and 3
When addressing the claims subject to these rejections, the Examiner
applied Aronov, Capote and additional references. See Final Act. 4--5.
Appellants, however, do not direct us to any error in the Examiner's findings
or conclusions as to the additional references, Murao and Zimmer. Rather,
Appellants argue that, like Capote, the additional references, do not remedy
the deficiency in Aronov. App. Br. 12.
For the reasons discussed above, we find no deficiency in the
combined teachings of Aronov and Capote that requires curing by Murao
and/or Zimmer. Thus, we also affirm the rejections of claims 2---6 and 24--44
under 35 U.S.C. § 103.
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Appeal2014-004789
Application 12/964,717
DECISION/ORDER
The Examiner's rejections of claims 1--44 under 35 U.S.C. § 103(a)
are 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).
AFFIRMED
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