Ex Parte Chan et al

Patent Trial and Appeal Board

Aug 22, 2018

13231866 (P.T.A.B. Aug. 22, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO.
13/231,866
109855 7590
Quest Diagnostics
1311 Calle Batido
FILING DATE
09/13/2011
08/24/2018
San Clemente, CA 92673
FIRST NAMED INVENTOR
Sum Chan
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.
034827-9961 3108
EXAMINER
GAKH, YELENA G
ART UNIT PAPER NUMBER
1797
NOTIFICATION DATE DELIVERY MODE
08/24/2018 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 SUM CHAN and QIBO JIANG
Appeal2017-010422
Application 13/231,866
Technology Center 1700
Before BRADLEY R. GARRIS, CATHERINE Q. TIMM, and LILAN REN,
Administrative Patent Judges.
TIMM, Administrative Patent Judge.
DECISION ON APPEAL 1
STATEMENT OF THE CASE
Pursuant to 35 U.S.C. § 134(a), Appellants2 appeal from the
Examiner's decision to reject claims 1-3, 5, 7, 9, and 11 under 35 U.S.C.
1 In explaining our Decision, we cite to the Specification of September 13,
2011 (Spec.), Appeal Brief of February 20, 2017 (Appeal Br.), Examiner's
Answer of May 30, 2017 (Ans.), and Reply Brief of July 31, 2017 (Reply
Br.).
2 Appellants identify the real party in interest as Quest Diagnostics
Investments Incorporated. Appeal Br. 1.
Appeal2017-010422
Application 13/231,866
§ 102(b) as anticipated by Tang, 3 claims 4, 6, 8, 10, and 12 under 35 U.S.C.
§ 103(a) as obvious over Tang in view of Andreoli4 (or Andreoli in view of
Tang), and claims 13-15 under 35 U.S.C. § 103(a) as obvious over Tang and
Andreoli, further in view of Walton. 5 We have jurisdiction under
35 U.S.C. § 6(b).
We REVERSE.
The claims are directed to a method of determining the amount of
vitamin A in a sample by tandem mass spectrometry. See, e.g., claim 1.
According to the Specification, mass spectrometry "refers to an
analytical technique to identify compounds by their mass." Spec. ,r 31. The
Specification explains that "[a] 'mass spectrometer' generally includes an
ionizer and an ion detector." Id. To use the mass spectrometer, "one or
more molecules of interest are ionized, and the ions are subsequently
introduced into a mass spectrometric instrument where, due to a combination
of magnetic and electric fields, the ions follow a path in space that is
dependent upon mass ('m') and charge ('z')." Id. From the mass and
charge, one can calculate the mass-to-charge ratio m/z. Id.
The Specification further discloses that one may enhance the
resolution of the mass spectrometry (MS) technique using tandem mass
3 Tang et al., Cell proliferation inhibition and alterations in retinol
esterification induced by phytanic acid and docosahexaenoic acid, J. Lipid
Res.2007,48: 165-176.
4 Andreoli et al., Development of a simplified method for the simultaneous
determination of retinol, a-tocopherol, and B-carotene in serum by liquid
chromatography-tandem mass spectrometry with atmospheric pressure
chemical ionization, Anal. Bioanal. Chem. (2004) 378: 987-994.
5 Walton et al., Tandem Mass Spectrometry in Vitamin E Analysis, Biomed.
and Enviro. Mass Spectrometry, vol. 16, 289-298 (1988).
2
Appeal2017-010422
Application 13/231,866
spectrometry (MS/MS). Spec. ,r 81. Tandem mass spectrometry adds
further steps of filtering a precursor ion (parent ion) that was generated in
the initial mass spectrometry procedure and fragmenting it into fragment
(daughter or product) ions. Id. According to the Specification:
Id.
In this technique, a precursor ion ( also called a parent ion)
generated from a molecule of interest can be filtered in an MS
instrument, and the precursor ion subsequently fragmented to
yield one or more fragment ions ( also called daughter ions or
product ions) that are then analyzed in a second MS procedure.
By careful selection of precursor ions, only ions produced by
certain analytes are passed to the fragmentation chamber, where
collisions with atoms of an inert gas produce the fragment ions.
Because both the precursor and fragment ions are produced in a
reproducible fashion under a given set of
ionization/fragmentation conditions, the MS/MS technique may
provide an extremely powerful analytical tool. For example, the
combination of filtration/fragmentation may be used to
eliminate interfering substances, and may be particularly useful
in complex samples, such as biological samples.
Appellants' tandem mass spectrometry uses vitamin A as the starting
material. Vitamin A is ionized to form a vitamin A precursor (parent) ion
having a mass-to-charge ratio of about 269.30 ± 0.80. This precursor
(parent) ion is then further fragmented into one or more fragment ( daughter
or product) ions including a fragment ion having a mass-to-charge ratio of
about 105.00 ± 0.80. Claim 1 is illustrative:
1. A method for determining the amount of vitamin A
in a sample by tandem mass spectrometry, said method
compnsmg:
3
Appeal2017-010422
Application 13/231,866
a. subjecting vitamin A from a sample to ionization
under conditions suitable to produce one or more ions
detectable by mass spectrometry; and
b. determining the amount of one or more of said
ions by tandem mass spectrometry, wherein tandem mass
spectrometry comprises fragmenting a vitamin A precursor ion
having a mass to charge ratio of about 269.30 ± 0.80 into one
or more fragment ions comprising a fragment ion having a
mass to charge ratio of about 105.00 ± 0.80;
wherein the amount of the one or more fragment ions
determined in step (b) is related to the amount of vitamin A in
the sample.
Appeal Br. 10 ( claims appendix).
OPINION
We agree with Appellants that Tang fails to describe the method of
claim 1, the only independent claim. Appeal Br. 7; Reply Br. 1-2.
As a first matter, Tang's mass spectrometry method is a method for
identifying retinyl esters generated during drug treatments; it is not a method
for determining the amount of vitamin A in a sample by tandem mass
spectrometry. Seep. 167 col. 1 ("Mass spectrometric analysis of retinoids,"
which states that the method is used to identify REs (retinyl esters) (see
abbreviations at p. 165)). Retinyl esters are a derivative of retinol (Vitamin
A), but retinyl esters are of different chemical structure than retinol.
Nor does Tang describe the specific steps of claim 1.
Tang does not disclose a step of subjecting vitamin A from a sample
to ionization. As evidenced by the portion of Tang's page 167 reproduced
by the Examiner in the Answer (Ans. 3), Tang teaches plating cells (PC-3
4
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Application 13/231,866
cells that stably overexpress exogeneous human LRA T) and culturing these
cells with various drugs in the presence or absence of retinol. Tang 167 col.
1, 3rd full para. Enzymes in the culture convert vitamin A (retinol) to retinyl
esters (REs ). Tang 165 col. 2, first full para. Tang harvests the cells and
extracts the retinyl ester retiniods. Tang 167, col 1, 3rd full para. It is the
retinyl ester that is subject to ionization, not retinol (vitamin A). Id.
Nor does Tang perform the determining step (step b) of claim 1. For
this step, the Examiner cites to the left column of page 171 of Tang. Ans. 3.
This portion of Tang discloses a method of using a known retinyl palmitate
(RP), a type of retinyl ester, collected after high performance liquid
chromatography (HPLC) separation of retinoids, to identify and characterize
novel RE peaks eluted at 50.5 and 54 min. HPLC retention times. Tang 170,
col. 2, last para. to 171 col. 1. The known RP, when subjected to mass
spectrometry, resulted in fragment ions at m/z 269.2, 480.5, and 524.5. Tang
171 col. 1. But Tang does not disclose further fragmenting the 269 .2 m/z ion
"into one or more fragment ions comprising a fragment ion having a mass to
charge ratio of about 105.00 ± 0.80." Instead, Tang discloses further
fragmenting the 524.5 m/z ion. Id. Although one of the further fragmented
ions has an m/z of 105, this further fragmented ion is not the result of a step
of fragmenting "a vitamin A precursor ion having a mass to charge ratio of
about 269.30 ± 0.80," it is the result of fragmenting the 524.5 m/z ion. Thus,
this portion of Tang does not support the Examiner's finding that Tang
teaches the fragmenting step of claim 1.
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Application 13/231,866
Appellants have identified a reversible error in the Examiner's
anticipation rejection. This error carries over to all the rejections. Thus, we
do not sustain any of the Examiner's rejections.
CONCLUSION
In summary:
1-3, 5, 7, 9, § 102(b) Tang
11
4, 6, 8, 10, § 103(a) Tang, Andreoli
12
13-15 § 103(a) Tang, Andreoli,
Walten
Summar
DECISION
The Examiner's decision is reversed.
REVERSED
6
1-3, 5, 7, 9,
11
4, 6, 8, 10,
12
13-15
1-15