Ex Parte Goldman et al

Patent Trial and Appeal Board

Jun 28, 2016

12641227 (P.T.A.B. Jun. 28, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO.
12/641,227
109855 7590
Quest Diagnostics
1311 Calle Batido
FILING DATE
12/17/2009
06/30/2016
San Clemente, CA 92673
FIRST NAMED INVENTOR
Mildred M. Goldman
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.
034827-0328 1212
EXAMINER
SODERQUIST, ARLEN
ART UNIT PAPER NUMBER
1797
NOTIFICATION DATE DELIVERY MODE
06/30/2016 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 MILDRED M. GOLDMAN and NIGEL J. CLARKE1
Appeal2015-000290
Application 12/641,227
Technology Center 1700
Before LINDA M. GAUDETTE, MARK NAGUMO, and
CHRISTOPHER L. OGDEN, Administrative Patent Judges.
OGDEN, Administrative Patent Judge.
DECISION ON APPEAL
Appellants appeal under 35 U.S.C. § 134(a) from the Examiner's final
decision rejecting claims 1-2 7, 2 9, and 3 0 in the above-identified
application. We have jurisdiction pursuant to 35 U.S.C. § 6(b).
We AFFIRM.
BACKGROUND
Appellants' invention relates to methods for measuring certain
estrogenic compounds as analytes for hormone replacement therapy (HR T)
1 According to Appellants, the real party in interest is Quest Diagnostics
Investments Incorporated. Appeal Br. 1.
Appeal2015-000290
Application 12/641,227
using mass spectrometry. Spec. iii! 2, 8. Independent claim 1 is
representative:
1. A method for determining the level of circulating
estrogenic compounds in an individual undergoing hormone
replacement therapy (HR T), the method comprising:
a. ionizing two or more underivatized estrogenic
compounds obtained from a plasma or serum sample of an
individual undergoing HRT under conditions suitable to
produce one or more ions detectable by mass spectrometry from
each of said two or more estrogenic compounds, wherein said
two or more estrogenic compounds are selected from the group
consisting of estrone (E 1 ), estrone sulfate (E 1 s ), 17 a-estradiol
(E2a), l 7B-estradiol (E2b), estradiol sulfate (E2s), estriol (E3),
equilin (EQ), l 7a-dihydroequilin (EQa), l 7B-dihydroequilin
(EQb), equilenin (EN), l 7a-dihydroequilenin (ENa), l 7B-
dihydroequilenin (ENb), and ~8,9-dehydroestrone (dEl), and
wherein said two or more estrogenic compounds are ionized
from a single sample injection;
b. determining the amounts of one or more ions from each
of the two or more estrogenic compounds by tandem mass
spectrometry; and
c. using the amounts of one or more ions from each of the
two or more estrogenic compounds to determine the amounts of
each of the two or more estrogenic compounds in the body fluid
sample of the individual.
Appeal Br. 13 (emphasis added). Independent claims 19 and 24 are also
directed to methods, and contain similar limitations. See id. at 16, 18.
The Examiner maintains the following grounds of rejection:
I. Claims 1-14, 16-18, 24-26 and 29 under 35 U.S.C. § 103(a) as
being unpatentable over U.S. Patent No. US 6,855,703 Bl [hereinafter Hill]
(issued Feb. 15, 2005) in view of Tiedong Guo et al., Steroid Profiles Using
Liquid Chromatography-Tandem Mass Spectrometry with Atmospheric
Pressure Photoionization Source, 128 Archives Pathology & Laboratory
Med. 469 (2004) and Toshiyuki Yasui et al., Serum Estrogen Level After
2
Appeal2015-000290
Application 12/641,227
Hormone Replacement Therapy and Body Mass Index in Postmenopausal
and Bilaterally Ovariectomized Women, 50 Maturitas 19 (2005). See Final
Action 2-5.
II. Claims 14-15, 19-23, 26, 27, and 30 as being unpatentable over
Hill in view of Guo and Yasui, and further in view of Cohesive
Technologies Inc., Quantification of Steroids from Plasma and/or Serum
Using Turbulent Flow Chromatography, LCGC (Sept. 2, 2005),
http://www. chromatographyonline. com/ quantification-steroids-plasma-
andor-serum-using-turbulent-flow-chromatography. See Final Action 5-7.
Appellants argue all the claims as a group. See Answer 9-11.
Therefore, consistent with the provisions of 37 C.F.R. § 41.37(c)(l)(iv)
(2013), we limit our discussion to independent claim 1, with which all
claims stand or fall.
DISCUSSION
The Examiner finds that Hill teaches a method of analyzing mixtures
of estrogenic compounds, including at least two of the listed compounds in
claim 1, step a. Final Action 2-3. According to the Examiner, Hill teaches
that HPLC with "one or more suitable detectors" may be used, id. at 3
(citing Hill 9:52-65), and that a preferred embodiment is the analysis of
equine estrogenic compounds in commercially available tablets, but that
other embodiments are not foreclosed, id.; see also Hill 10: 15-31. The
Examiner notes that Hill "does not teach the analysis of these compounds
from an individual undergoing hormone replacement therapy," id.; see also
Answer 9, but finds that Hill discusses treatment of humans and the use of
estrogenic compounds in a context relating to hormone therapy, see Answer
10 (citing Hill 8:1-23).
3
Appeal2015-000290
Application 12/641,227
The Examiner also finds that Guo teaches the measurement of
steroids, including estriol and estradiol, in serum samples from patients,
using liquid chromatography-tandem mass spectrometry. See Final Action
3--4. The Examiner determines that it would have been obvious to
"simultaneously measure multiple estrogenic compounds in a highly precise
and accurate manner as taught by Guo," id. at 5, based on the advantages of
that method as taught by Guo and summarized by the Examiner in the Final
Action, see id. at 3--4. The Examiner also cites Yasui as teaching the
measurement of serum estrogen levels after hormone replacement therapy,
using chromatography followed by radioimmunoassay. See id. 4-5.
Therefore, the Examiner determines, it would have been obvious to have
applied the teachings of Hill and Guo to the context of analyzing the serum
levels of estrogenic compounds administered as part of hormone
replacement therapy, as taught by Yasui. See id. at 5.
First, Appellants argue that Hill's disclosure regarding the analysis of
dissolved equine estrogenic compounds "does not suggest a quantitation
assay of a plasma or serum sample of a human that has undergone HR T (of
the present claims)," or the analysis of "two or more" estrogenic compounds
as required by claim 1. Appeal Br. 1 O; see also Reply Br. 3.
We do not find this argument persuasive of reversible error. The
Examiner's rejections are based on the teachings of Hill in combination with
other references. "Non-obviousness cannot be established by attacking
references individually where the rejection is based upon the teachings of a
combination of references." In re Merck & Co., Inc., 800 F.2d 1091, 1097
(Fed. Cir. 1986) (citing In re Keller, 642 F .2d 413, 425 (CCP A 1981 )).
Moreover, as the Examiner correctly points out, Hill does disclose the
4
Appeal2015-000290
Application 12/641,227
quantitation of two or more estrogenic components. See Answer 9-10
(citing Hill 16:35--44, 35:3-15, 33-38).
Second, Appellants argue that "Guo explicitly discourages using
immunoassays (such as those of Yasui)," in part because according to Guo,
"many immunoassays lack specificity owing to cross-reactivity." Appeal
Br. 10 (citing Guo 649). Nevertheless, according to Appellants, "the later
published Yasui chose to use immunoassays for determining serum
estrogen and estradiol of HR T patients because of the higher sensitivity."
Id. Therefore, Appellants argue that "one of ordinary skill in the art would
have been motivated against combining the teachings of Guo (which
explicitly discourages using immunoassay) with those of Yasui (which
suggests using immunoassays specifically for estrogen measurement in HR T
patients due to high sensitivity)." Id. at 10-11; see also Reply Br. 3--4.
While Yasui used a different analytical method than Guo, Appellants
have not established that either Yasui or Guo teaches away from the use of
tandem mass spectrometry for analyzing plasma or serum samples in a
patient undergoing HRT. In particular, Appellants have not provided a
persuasive reason for us to conclude that the references "criticize, discredit,
or otherwise discourage" investigation into the invention of claim 1. DePuy
Spine, Inc. v. Medtronic Sofamor Danek, Inc., 567 F.3d 1314, 1327 (Fed.
Cir. 2009) (quoting In re Fulton, 391F.3d1195, 1201 (Fed. Cir. 2004)).
Moreover, Appellants acknowledge that Guo teaches that using tandem mass
spectrometry can be advantageous in comparison to other methods of
measuring estrogenic compounds, such as that used by Yasui. See Appeal
Br. 10 (citing Guo 649). That the benefit disclosed in Guo (e.g., higher
specificity) may come at the expense of some other benefit (e.g., higher
sensitivity) does not nullify the motivation to combine the teachings of the
5
Appeal2015-000290
Application 12/641,227
references. See Winner Int'! Royalty Corp. v. Wang, 202 F.3d 1340, 1349
n.8 (Fed. Cir. 2000). Nor does the fact that Yasui used a radioimmunoassay
method in the context of HR T treatment, rather than mass spectrometry,
mean that a person of ordinary skill in the art would have been dissuaded
from making a different choice than Yasui.
Therefore, we find no reversible error in the Examiner's decision to
reject independent claim 1. For the same reasons, we find no reversible
error in the Examiner's decision to reject claims 2-27, 29, and 30.
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. § l .136(a)(l )(iv).
AFFIRMED
6