Andrew Francis. Page et al.

Patent Trials and Appeals Board

Mar 24, 2020

13519391 - (D) (P.T.A.B. Mar. 24, 2020)

UNITED STATES PATENT AND TRADEMARK OFFICE
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
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
13/519,391 06/27/2012 Andrew Francis Page 243696 (34428-0007) 2062
29052 7590 03/24/2020
EVERSHEDS SUTHERLAND (US) LLP
999 PEACHTREE STREET, N.E.
SUITE 2300
ATLANTA, GA 30309
EXAMINER
HENRY, MICHAEL C
ART UNIT PAPER NUMBER
1623
NOTIFICATION DATE DELIVERY MODE
03/24/2020 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):
patentdocket@eversheds-sutherland.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte ANDREW FRANCIS PAGE and BRECK OLLAND PARKER
____________

Appeal 2019-000231
Application 13/519,391
Technology Center 1600
____________

Before ULRIKE W. JENKS, TIMOTHY G. MAJORS, and
MICHAEL A. VALEK, Administrative Patent Judges.

JENKS, Administrative Patent Judge.

DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from Examiner’s
decision to reject claims 1–4 and 7–9. We have jurisdiction under
35 U.S.C. § 6(b).
We AFFIRM.

1 We use the word “Appellant” to refer to “applicant” as defined in 37
C.F.R. § 1.42(a). Appellant identifies the real party in interest as GE
Healthcare Bio-Sciences Corp. Appeal Br. 2.
Appeal 2019-000231
Application 13/519,391

2
STATEMENT OF THE CASE
Claims 1–4 and 7–9 are on appeal, and can be found in the Claims
Appendix of the Appeal Brief.2 Claim 1, reproduced below, is illustrative of
the claimed subject matter:
1. A solid matrix for storage of purified nucleic acid, wherein
the matrix is impregnated with inulin.
Appeal Br. 12
REFERENCE(S)
The prior art relied upon by Examiner is:
Name Reference Date
Burgoyne US 5,496,562 March 5, 1996
Chomczynski US 2006/0147944 A1 July 6, 2006
Cormier et al.
(“Cormier”)
WO 2005/042702 A2 May 12, 2005
Kravchenko et al., Preservation of Nucleic Acid Integrity in Guanidine
Thiocyanate Lysates of Whole Blood, 32 Russian Journal of Bioorganic
Chemistry 547–51 (2006) (“Kravchenko”)
REJECTION(S)
Appellant requests review of the following grounds of rejection made
by Examiner:
I. Claims 1, 3, 8, and 9 under 35 U.S.C. § 103(a) as unpatentable over
Burgoyne in view of Kravchenko and Cormier.
II. Claims 2, 4, and 7 under 35 U.S.C. § 103(a) as unpatentable over
Burgoyne, Kravchenko, and Cormier and further in view of
Chomczynski.

2 In this opinion we refer to the corrected Appeal Brief filed May 2, 2018
(“Appeal Br.”).
Appeal 2019-000231
Application 13/519,391

3
I. Obviousness over Burgoyne, Kravchenko, and Cormier
The issue is does the preponderance of evidence of record support
Examiner’s conclusion that a nucleic acid storage matrix impregnated with
inulin is obvious?
Findings of Fact
FF1. Burgoyne teaches:
Transport of blood DNA as dried, purified DNA is most
desirable, but it requires a high standard of technical
assistance to be available at the places of collection. . . .
Transport of liquid blood involves the need for sterility of
collection and . . . [t]he transport of liquid blood or
frozen blood also demands temperature control and an
appropriate transport system other than the regular postal
system.
Burgoyne 1:40–52. “Blood dried onto filter paper is a proven
alternative . . . and it has been shown that DNA can be extracted and
isolated from dried whole blood spots.” Id. at 1:58–60.
FF2. Burgoyne teaches a solid support medium for storage of DNA.
Burgoyne, Abstract. Solid support includes cellulose-based paper or a
micromesh of synthetic plastics material. Id. at 2:21–23.
FF3. DNA samples applied to Burgoyne’s solid support include blood (id.
at 4:41–42) as well as plasmids or other viral replicating forms (id. at
4:61–62).
FF4. Burgoyne teaches that the solid support contains a DNA-protecting
compound that is absorbed onto the solid support. Id. at 2:24–25.
Burgoyne teaches that “for long[-]term storage of purified DNA, the
DNA-protecting compound or composition comprises uric acid,
Appeal 2019-000231
Application 13/519,391

4
together with a weak base to convert the uric acid to a urate salt and to
provide an alkaline pH between 8.0 and 9.5.” Id., see id. at 2:65–67.
FF5. Burgoyne teaches that paper treated with DNA-protecting compound
allowed for the recovery of 100% transformationally active DNA. See
id. at 6:9–20.
FF6. Cormier teaches “compositions for stabilizing dried nucleic acids with
carbohydrates such as non-reducing sugars, polysaccharides, and
reducing sugars.” Cormier, Abstract. Cormier teaches “methods for
retarding the degradation of dried nucleic acids that comprise mixing
the nucleic acid with one or more stabilizing agents and one or more
surface active agents and dry coating the mixture onto a solid
substrate.” Id. ¶ 81.
FF7. Cormier teaches that the “stabilizing agent is preferably selected from
the group consisting of dextran, soluble starch, dextrin, and inulin.”
Id. ¶ 20, see also id. 28, claims 1 and 7.
FF8. Kravchenko teaches that the use of guanidine thiocyanate allows for
the retention of RNA and DNA integrity upon storage. Kravchenko
Abstract, see id. at 548 (“the samples of whole blood can directly be
stored as guanidine thiocyanate lysates . . . and ensures the
preservation of RNA and DNA”). Kravchenko teaches that
“[g]uanidine thiocyanate is the most potent among known
ribonuclease denaturing agents widely used in RNA isolation[].
Hence, it seemed quite natural to use it for storage of the samples.”
Kravchenko 548.
FF9. Kravchenko teaches storing freshly collected blood in a tube that
contains a conserving solution to create a lysate. Kravchenko 550. The
Appeal 2019-000231
Application 13/519,391

5
resulting lysate contains “4 M guanidine thiocyanate, 25 mM sodium
citrate (pH 7.5), 0.5% sarcosyl, 13 mM EDTA, and 1.3%
2-mercaptoethanol.” Id.

Principle of Law
“If the claim extends to what is obvious, it is invalid under § 103.”
KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 419 (2007).
It is prima facie obvious to combine two compositions each of
which is taught by the prior art to be useful for the same
purpose, in order to form a third composition which is to be
used for the very same purpose. . . . [T]he idea of combining
them flows logically from their having been individually taught
in the prior art.
In re Kerkhoven, 626 F.2d 846, 850 (CCPA 1980) (citations omitted).

Analysis
Burgoyne teaches a nucleic acid storage matrix that is impregnated
with a compound that protects the nucleic acid from degradation. FF1–FF5.
Examiner acknowledges that the difference between Burgoyne and the
present claims is that the claimed composition contains inulin. Ans. 4.
Cormier teaches sugars, such as inulin, as nucleic acid stabilizing agents on
solid surfaces. FF6–FF7. Kravchenko teaches that guanidine thiocyanate is a
known ribonuclease denaturation agent that can be used to store blood and
maintains the integrity of nucleic acids, such as RNA and DNA. FF8–FF9.
Applying the guidance set forth in KSR to the facts here, we conclude
that the ordinary artisan of ordinary creativity familiar with the teachings of
nucleic acid stabilization would have selected known equivalent nucleic acid
stabilizing agents of Cormier and applied them to the nucleic acid stabilizing
Appeal 2019-000231
Application 13/519,391

6
matrix taught in Burgoyne because such a combination is merely a
“predictable use of prior art elements according to their established
functions.” KSR, 550 U.S. at 417. We further conclude that the ordinary
artisan would have found it obvious to incorporate guanidine thiocyanate,
because this compound is taught in Kravchenko to be a nucleic acid
stabilizing agent, into the composition of Burgoyne and Cormier in order to
further stabilize the nucleic acids and prevent degradation upon storage.
Appellant contends that the cited art is non-analogous art and
therefore there is no reason to combine their teachings. See Appeal Br. 5–9;
Reply Br. 5–8. Specifically, Appellant contends that there is no overlap
between Burgoyne and Cormier, and that Kravchenko does not fill the gaps
between the other references. Appeal Br. 6; Reply Br. 5. Appellant contends
that “the surprising technical effect of inulin, as demonstrated in Table 1 of
Appellant’s specification, is to significantly increase the yield of eluted
DNA.” Appeal Br. 9; Reply Br. 8. According to Appellant, both Cormier
and Burgoyne are silent about elution yields of DNA. Appeal Br. 9; Reply
Br. 9.
After considering the evidence and the arguments, we conclude the
weight of the evidence favors Examiner’s conclusion of obviousness.
Accordingly, we adopt Examiner’s reasoning (see Grounds of Rejection,
Ans. 3–6), and agree that Examiner properly found Appellant’s arguments
unpersuasive (see Response to Argument, Ans. 8–35). We provide the
following points for emphasis.
We are not persuaded by Appellant’s non-analogous art argument.
“Although § 103 does not, by its terms, define the ‘art to which [the] subject
matter [sought to be patented] pertains,’ this determination is frequently
Appeal 2019-000231
Application 13/519,391

7
couched in terms of whether the art is analogous or not, i.e., whether the art
is ‘too remote to be treated as prior art.’” In re Clay, 966 F.2d 656, 658 (Fed.
Cir. 1992) (citing In re Sovish, 769 F.2d 738, 741 (Fed. Cir. 1985)). “Two
criteria have evolved for determining whether prior art is analogous: (1)
whether the art is from the same field of endeavor, regardless of the problem
addressed, and (2) if the reference is not within the field of the inventor’s
endeavor, whether the reference still is reasonably pertinent to the particular
problem with which the inventor is involved.” Id. at 658–59. Here, Examiner
identified that all “the applied references (Burgoyne, Kravchenko and
Cormier) disclose teachings directed to DNA” and its desire to maintain the
integrity of nucleic acids upon storage. Ans. 14.
For example, Burgoyne disclose a solid medium for storage of
DNA, including blood DNA, comprising a solid matrix having
a compound or composition which protects against degradation
of DNA incorporated into or absorbed on the matrix. And,
Kravchenko et al. disclose or suggest that DNA can be
preserved and/or stabilized (i.e.; retain its integrity) when
guanidine thiocyanate (a denaturant). . . . Cormier et al. disclose
or suggest that inulin (a preferable polysaccharide) can be used
for stabilizing (e.g., retarding the degradation of the nucleic
acid) dried nucleic acids (which includes DNA).
Ans. 14; see FF1–FF9.
We agree with Examiner’s finding that the cited references are from
the same field of endeavor in this case nucleic acid preservation and
prevention of degradation of the nucleic acid product. Accordingly, we are
not persuaded by Appellant’s contention that the cited art is not analogous.
We are also not persuaded by Appellant’s surprising technical effects
argument. See Appeal Br. 9; Reply Br. 9. Specifically, Appellant contends
that the Specification demonstrates that the use of inulin “significantly
Appeal 2019-000231
Application 13/519,391

8
increase[s] the yield of eluted DNA.” Reply Br. 8. Examiner counters that
inulin’s effect on increasing yield is expected rather than surprising. See
Ans. 34. Specifically, Examiner explains that based on the teachings of
Cormier,
one of ordinary skill in the art would expect that inulin, the
preferred polysaccharide which stabilizes DNA, would
significantly increase the yield of eluted DNA since less DNA
would be degraded, destabilized or disintegrated and thus more
will be present which would result in an increase yield and
would therefore also cause or provide an improved storage
matrix that increases the percentage of the applied DNA that
can be eluted from the solid matrix.
Id. By “stabilizing nucleic acid (which includes DNA) would also
significantly increase the collection or yield of eluted DNA and thus the
amount or percent of DNA applied.” Id. We agree with Examiner that there
are at least two ways to increase yield of DNA. One way is to ensure that all
DNA that is bound to the solid matrix is also able to elute from the solid
matrix. The other way it to prevent DNA from degrading while bound to the
solid matrix in order to provide higher yield when it is eluted from the
matrix. Thus, the record supports Examiner’s determination that a skilled
artisan would expect increased yield of eluted DNA by employing inulin as
DNA stabilizing agent as taught in Cormier. FF7.
Insofar that Appellant’s surprising technical effects argument is an
unexpected results argument we are also not persuaded. The burden of
demonstrating unexpected results rests on the party asserting them. In re
Klosak, 455 F.2d 1077, 1080 (CCPA 1972). That burden has not been
carried here because Appellant has not established that the results achieved
using the recited matrix impregnated with inulin were unexpectedly superior
compared to the closest prior art, which are compositions disclosed by
Appeal 2019-000231
Application 13/519,391

9
Burgoyne. See In re Baxter Travenol Labs., 952 F.2d 388, 392 (Fed. Cir.
1991). Here, Burgoyne teaches that paper treated with the DNA-protecting
compound uric acid allowed for the recovery of 100% transformationally
active DNA, while the recovery of DNA from untreated matrix was only
10%. Burgoyne 6:18–20; FF5.
We conclude that the evidence cited by Examiner supports a prima
facie case of obviousness with respect to claim 1, and Appellant has not
provided sufficient rebuttal evidence or sufficient evidence of secondary
considerations that outweighs the evidence supporting Examiner’s
conclusion of obviousness. As Appellant does not argue the claims
separately, claims 3, 8, and 9 fall with claim 1. 37 C.F.R. § 41.37(c)(1)(iv).

II. Obviousness over Burgoyne, Kravchenko, Cormier, and Chomczynski
Examiner has rejected claim 2, 4, and 7 as obvious based Burgoyne,
Kravchenko, Cormier, and Chomczynski. Ans. 6–8; Final Act. 6–8.
Appellant’s only argument with respect to this rejection is that Chomczynski
“does not teach or suggest impregnating a matrix with inulin, and thus does
not cure the deficiencies of Burgoyne, Kravchenko, and Cormier.” Appeal
Br. 10. This argument is not persuasive because, as discussed above, we
conclude that Burgoyne, Kravchenko, and Cormier discloses or would have
made obvious a matrix impregnated with a nucleic acid stabilizing agent.
We affirm the rejection of claim 2, 4, and 7 for the reasons given by
Examiner.

Appeal 2019-000231
Application 13/519,391

10
CONCLUSION
In summary:
Claims
Rejected
35 U.S.C.
§
Reference(s)/Basis Affirmed Reversed
1, 3, 8, 9 103 Burgoyne,
Kravchenko,
Cormier
1, 3, 8, 9
2, 4, 7 103 Burgoyne,
Kravchenko,
Cormier
Chomczynski
2, 4, 7
Overall
Outcome
1–4, 7–9
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). See 37 C.F.R.
§ 1.136(a)(1)(iv).

AFFIRMED