Ex Parte Kleiber et al

Patent Trial and Appeal Board

Jul 26, 2016

13269195 (P.T.A.B. Jul. 26, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
13/269, 195 10/07/2011 Jorg Kleiber
22829 7590 07/28/2016
Roche Molecular Systems, Inc,
4300 Hacienda Drive
Pleasanton, CA 94588
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.
18242-US6 4540
EXAMINER
HUMPHREY, LOUISE WANG ZHIYING
ART UNIT PAPER NUMBER
1657
NOTIFICATION DATE DELIVERY MODE
07/28/2016 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):
misty.prasad@roche.com
pair_roche@firsttofile.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Exparte JORG KLEIBER, THOMAS WALTER, HERBERT HARTTIG,
CHRISTOPH LESNIAK, MARTIN MENNIG, MICHAEL RIEDLING, and
HELMUT SCHMIDT1
Appeal2014-005661
Application 13/269,195
Technology Center 1600
Before ERIC B. GRIMES, MELANIE L. McCOLLUM, and
RICHARD J. SMITH, Administrative Patent Judges.
SMITH, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a method
for separating nucleic acids from a fluid. We have jurisdiction under 35
U.S.C. § 6(b).
We affirm.
1 According to Appellants, the real party in interest is ROCHE
MOLECULAR SYSTEMS, INC. (Br. 5.)
Appeal2014-005661
Application 13/269,195
STATEMENT OF THE CASE
Claims on Appeal
Claims 13-18 are on appeal. (Claims Appendix, Br. 22-23.) Claim
13 is illustrative and reads as follows:
13. A method for separating nucleic acids from a fluid
containing the nucleic acids comprising:
a) bringing a sample that contains the nucleic acids in a fluid in
contact with a magnetic particle, the magnetic particle
comprising a magnetic core and an outer glass layer, said outer
glass layer completely covers the magnetic core and does not
contain boron oxide; and has an outer glass surface, under
conditions such that the nucleic acids bind to the glass surface;
and thereafter
b) separating the bound nucleic acids from the fluid.
Examiner Rejections
1. Claims 13-18 stand rejected under 35 U.S.C. § 103(a) as unpatentable
over Hawkins,2 Groves, 3 and Padhye,4 and if necessary5 in further view of
Woodard,6 Falleroni,7 Palladino,8 or Whitehead. 9 (Final Act. 2.) 10
2. Claims 13-18 stand rejected on the ground of nonstatutory
obviousness-type double patenting over claims 1-27 of U.S. Patent No.
2 Hawkins, US 5,898,071, issued Apr. 27, 1999 ("Hawkins").
3 Groves et al., EP 0343934 A2, published Nov. 29, 1989 ("Groves").
4 Padhye et al., US 5,658,548, issued Aug. 19, 1997 ("Padhye").
5 The subsequent references are not at issue in the instant appeal, and are
identified herein only for the sake of completeness.
6 Woodard et al., US 5,503,816, issued Apr. 2, 1996.
7 Falleroni et al., US 4,824,712, issued Apr. 25, 1989.
8 Palladino, US 5,458,813, issued Oct. 17, 1995.
9 Whitehead et al., 4,698,302, issued Oct. 6, 1987.
10 Office Action dated May 21, 2013.
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6,562,568, or claims 1---6 of U.S. Patent No. 6,870,047, or claims 1-11 of
U.S. Patent No. 6,255,477, or claims 1--4 of U.S. Patent No. 7,371,830, in
view of Groves and Padhye. 11 (Id. at 8.)
With respect to Rejection No. 1, Appellants argue claims 13-18 as a
group. Accordingly, we limit our consideration of that rejection to claim 13.
FINDINGS OF FACT
We adopt as our own the Examiner's findings and analysis concerning
the scope and content of the prior art. The following findings are included
for emphasis and reference convenience.
FF 1. The Examiner finds that Hawkins discloses DNA purification
and isolation, from a solution containing DNA, using magnetic
microparticles having a metal oxide core and a silane coating. (Final Act. 3,
citing Hawkins col. 1, 1. 30-col. 2, 1. 17; col. 3, 11. 1-15.)
FF 2. The Examiner finds that Groves discloses magnetic particles
having a core of magnetic material encapsulated in a metal oxide coating.
The metal oxide may include "biocompatible glasses," and provide "reactive
sites for binding to molecules of biological interest." The magnetic particles
can be used for separations. (Id., citing Groves col. 1, 1. 54; col. 4, 11. 13,
29-35.)
FF 3. The Examiner finds that Padhye discloses the use of silica
materials, such as glass particles, to separate DNA from other substances.
(Id. at 4, citing Padhye col. 2, 11. 61---68.)
11 No additional information is provided herein regarding these patents
because Appellants do not argue Rejection No. 2.
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DISCUSSION
Issue
Whether a preponderance of evidence of record supports the
Examiner's conclusion of obviousness under 35 U.S.C. § 103(a).
Analysis
Rejection No. I-Obviousness
The Examiner concluded that it would have been obvious "to
substitute a glass coating for the silane coating on the magnetic
microparticles" taught by Hawkins. (Ans. 5.) Furthermore, the glass
coating would "bind and separate nucleic acids from a solution," as
suggested by Groves, and as further suggested by Padhye' s teaching of using
glass particles for DNA separation. (Id.) Moreover, according to the
Examiner, "[g]lass coated magnetic particles would have been an obvious
alternative to the silane coated magnetic particles of Hawkins." (Id.)
We find that the Examiner has satisfied the burden of showing "some
articulated reasoning with some rational underpinning to support the legal
conclusion of obviousness." KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398,
418 (2007). Moreover, the Examiner has established a prima facie case of
obviousness and, as discussed below, Appellants have not overcome that
prima facie case.
Combination of References
Appellants acknowledge that "Hawkins teaches isolating nucleic acids
using microparticles with a metal oxide core and a silane coating" and that
Padhye "teaches using glass powder to isolate nucleic acids." (Br. 14.)
However, Appellants argue that, in analyzing Groves, "the examiner put
incorrect emphasis on the fact that magnetic particles are encapsulated in a
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metal oxide coating that can be Si02 (i.e., glass like)." (Id. at 14-15.) As a
result, according to Appellants, "the combination of glass and magnetic
particles to isolate nucleic acids, is not found in the prior art." (Id. at 15.)
We are not persuaded. The test for obviousness is what the combined
teachings of Hawkins, Groves, and Padhye would have suggested to those of
ordinary skill in the art. See In re Keller, 642 F.2d 413, 425 (CCPA 1981)
(citing cases). Here, we agree with the Examiner that it would have been
obvious to coat the magnetic particles of Hawkins with the glass coating of
Groves because Padhye teaches using glass particles for DNA separation.
(FF 1-3.)
Reasonable Expectation of Success
Appellants argue that a person of ordinary skill in the art would not
have had any expectation of success in replacing the silane coating of
Hawkins with glass. (Br. 15-16.) In support of that argument, Appellants
point to Padhye' s statement that contaminants bind "with some tenacity" to
glass, requiring "at least four separate washes before nucleic acids can be
eluted." (Id. at 16, citing Padhye col. 8, 1. 24-col. 9, 1. 29.) Appellants also
point to the Walter Declaration, 12 discussed further below, for the
proposition that the combination of magnetic particles and glass was thought
to be unworkable. (Id.)
We are not persuaded. The reasonable expectation of success
requirement "refers to the likelihood of success in combining references to
meet the limitations of the claimed invention." Intelligent Bio-Systems, Inc.
12 Declaration Submitted with Response to an Office Action, by Thomas
Walter, dated Mar. 1, 2013 ("Walter Declaration").
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v. lllumina Cambridge Ltd., 821F.3d1359, 1367 (Fed. Cir. 2016). Here,
claim 13 does not exclude the possibility of multiple washes to remove
contaminants (if any). Furthermore, Groves teaches magnetic particles,
having a coating that may include glasses (FF 2), that are "suitable for use in
biological separations." (Groves, col. 1, 11. 4--5.) Moreover, the
unsupported Walter Declaration does not overcome the reasonable
expectation of success evidenced by the prior art (e.g. Groves), or provide
any basis for concluding that overcoming any purported challenges in
combining magnetic particles and glass would not have been within the skill
of an ordinary artisan. See KSR, 550 U.S. at 421 ("A person of ordinary skill
is also a person of ordinary creativity, not an automaton."); In re Sovish, 769
F.2d 738, 743 (Fed. Cir. 1985) (skill is presumed on the part of one of
ordinary skill in the art).
Hindsight
Appellants argue that "[t]he teachings of Padhye regarding impurities
tightly bound to glass would be of concern to a person of ordinary skill
contemplating adding glass coating to magnetic particles" and that "the
examiner dismissed this concern by simply stating that ' [ t ]he glass coating
would have been expected to bind and separate nucleic acids as desired by
Hawkins, and provide the function of glass for nucleic acid purification as
disclosed by Padhye. '" (Br. 16-17, quoting Final Act. 5---6, emphasis
Appellants'.) According to Appellants, " [ s ]uch certainty [by the Examiner]
in the success of the method is possible only in hindsight." (Id. at 17.)
We are not persuaded. The sentence immediately preceding the one
quoted by Appellants specifically refers to Groves and Padhye as "disclosing
glass binding biological material and nucleic acids" and states that "it would
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have been obvious [that] a glass coating on the magnetic microparticles of
Hawkins will provide the function of the silane coating." (Final Act. 5.)
Accordingly, rather than using hindsight, the Examiner points to specific
disclosures in the prior art that describe the limitations of Appellants'
claimed method. (Id. at 2-7.)
Declaration
Appellants argue that the Walter Declaration was not given adequate
weight by the Examiner, apparently because if it had been given adequate
weight, the obviousness rejection would have been rebutted. (Br. 17-21.)
Appellants also argue specific "anticipated difficulties" raised in the Walter
Declaration, and conclude by stating "[t]he correct inquiry would have asked
whether the alleged combination could have been made despite the concern
for the problems set forth in Padhye and the Declaration." (Id. at 20-21.)
We are not persuaded. We note that the Examiner addressed the
Walter Declaration and the issues raised therein. (Final Act. 6-7.)
Moreover, the Examiner addressed the unsupported contentions in the
Walter Declaration by referencing the teachings of the prior art. (Id.)
Accordingly, we agree with the Examiner that the Walter Declaration does
not rebut the prima facie case of obviousness and, in particular, we are not
persuaded by Appellants' argument that the Examiner did not give the
Walter Declaration adequate weight.
Appellants also argue that the Walter Declaration supports the
position that magnetic particles and glass "were believed to be incompatible
during isolation of nucleic acids." (Br. 18.) Specifically, Appellants point
to paragraphs 7 and 8 of the Walter Declaration as support for the belief that
multiple washes of the particles would be necessary, that the presence of the
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magnetic core would make the washes ineffective, and that "chaotropic salts
necessary for binding of nucleic acids to glass would be especially difficult
to get rid of ... and detrimental to subsequent uses of the isolated nucleic
acids." (Id. at 18-19.)
We find that these unsupported contentions (e.g., the need for multiple
washes or "subsequent uses" of the nucleic acids) are not pertinent to the
claim limitations or, at most, the type of concerns or problems that a person
of ordinary skill would have had sufficient skill to address. See Sovish, 769
F.2d at 743.
Conclusion of Law
A preponderance of evidence of record supports the Examiner's
conclusion that claim 13 is obvious under 35 U.S.C. § 103(a). Claims 14--18
were not argued separately and fall with claim 13.
Rejection No. 2-0bviousness-type Double Patenting
Appellants present no arguments in response to Rejection No. 2.
Accordingly, Rejection No. 2 is affirmed. See 37 C.F.R. § 41.37(c)(l)(iv);
Hyattv. Dudas, 551F.3d1307, 1314 (Fed. Cir. 2008).
SUMMARY
We affirm the rejections of all claims on appeal.
TIME PERIOD FOR RESPONSE
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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