Dang, Tri T. et al.

Patent Trials and Appeals Board

Dec 12, 2019

14728442 - (D) (P.T.A.B. Dec. 12, 2019)

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.
14/728,442 06/02/2015 Tri T. Dang G&C 130.129-US-01 1053
12813 7590 12/12/2019
Gates & Cooper LLP - Minimed
6060 Center Drive
Suite 830
Los Angeles, CA 90045
EXAMINER
KIPOUROS, HOLLY MICHAELA
ART UNIT PAPER NUMBER
1799
NOTIFICATION DATE DELIVERY MODE
12/12/2019 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):
docketing-us@gates-cooper.com
gates-cooper@blackhillsip.com
rs.patents.one@medtronic.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte TRI T. DANG, SARKIS AROYAN, and
JESPER SVENNING KRISTENSEN
Appeal 2019-003538
Application 14/728,442
Technology Center 1700
Before LINDA M. GAUDETTE, ELIZABETH M. ROESEL, and
JANE E. INGLESE, Administrative Patent Judges.
ROESEL, Administrative Patent Judge.

DECISION ON APPEAL
STATEMENT OF THE CASE
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision to reject claims 1, 3–5, 7–9, and 21. 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 Medtronic
MiniMed, Inc. Appeal Br. 2.
Appeal 2019-003538
Application 14/728,442

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CLAIMED SUBJECT MATTER
The claims are directed to a method of inhibiting damage to a
saccharide sensor that can result from a radiation sterilization process.
Claim 1 is illustrative of the claimed subject matter and is reproduced below
with underlining added for emphasis:
1. A method of inhibiting damage to a saccharide sensor
that can result from a radiation sterilization process, the method
comprising combining the saccharide sensor with an aqueous
radioprotectant formulation during the sterilization process,
wherein:
the saccharide sensor comprises mannose binding lectin;
the aqueous radioprotectant formulation comprises a
saccharide selected for its ability to bind the mannose binding
lectin, the aqueous radioprotectant formulation further
comprises at least one reactive oxygen species that includes
sodium nitrate; and
performing the sterilization process under conditions
selected so that the saccharide binds the mannose binding lectin
and the reactive oxygen species absorbs free electron energy
generated by the radiation sterilization process, wherein said
conditions include a temperature:
where the aqueous radioprotectant formulation is a
liquid solution; and
below 10°C, thereby inhibiting damage to the
saccharide sensor.
Claim 21 is identical to claim 1, except that claim 21 recites “a nitrate”
instead of “sodium nitrate.”
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Application 14/728,442

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REFERENCES
The prior art relied upon by the Examiner is:
Name Reference Date
Goldstein US 2004/0209235 A1 Oct. 21, 2004
Kristensen US 2013/0130395 A1 May 23, 2013
Tseng US 2014/0342014 A1 Nov. 20, 2014
REJECTIONS
The Examiner maintains the following rejections under 35 U.S.C.
§ 103:
1. Claims 1, 4, 5, 7–9, and 21 over Kristensen and Goldstein; and
2. Claim 3 over Kristensen, Goldstein, and Tseng.
OPINION
Independent Claims 1 and 21
The Examiner finds that Kristensen discloses a method of inhibiting
damage to a saccharide sensor that can result from a radiation sterilization
process and that Kristensen’s method includes most of the limitations of
claims 1 and 21. Final Act. 4–5, 7. The Examiner finds that Kristensen
discloses an aqueous radioprotectant formulation comprising a species for
quenching radicals, but does not disclose that the radical quenching species
includes a reactive oxygen species comprising “sodium nitrate” or “a
nitrate,” as recited in claims 1 and 21, respectively. Id. at 5, 7.
The Examiner finds that Goldstein discloses a method for inhibiting
damage to human or animal tissue during radiation sterilization of the tissue
prior to implantation, including the steps of placing the tissue in a protective
solution and irradiating the tissue. Final Act. 5, 8 (citing Goldstein ¶¶ 2, 10,
11, 29, 34, 39, 40). The Examiner finds that Goldstein discloses that the
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protective solution includes a radical scavenger preferably comprising
sodium nitrate. Id. (citing Goldstein ¶¶ 58–61). The Examiner finds that it
would have been obvious to a person of ordinary skill in the art to modify
the method disclosed by Kristensen such that the radioprotectant formulation
includes a reactive oxygen species comprising sodium nitrate, as taught by
Goldstein. Id.
Appellant challenges the Examiner’s obviousness rejection, arguing
that Goldstein’s sterilization procedures are carried out on tissue frozen at
cryogenic temperatures of -30° C. or less, which is well below the freezing
point of aqueous solutions. Appeal Br. 4; Reply Br. 3–4. Appellant argues
that Goldstein cannot be combined with Kristensen because Goldstein
teaches away from the claimed methods in which the sterilization process is
performed at a temperature below 10° C. but above freezing so that the
aqueous radioprotectant formulation is a liquid solution. Appeal Br. 5;
Reply Br. 4.
After considering Appellant’s briefs, the Examiner’s Answer, the
cited teachings of the references, and the record as a whole, we determine
that Appellant does not identify reversible error in the Examiner’s decision
to reject claims 1 and 21 over Kristensen and Goldstein.
Appellant acknowledges that Goldstein “teaches methods for the
sterilization of cryopreserved tissue and identifies sodium nitrate as a free
radical scavenger useful in these methods.” Appeal Br. 4. Appellant does
not dispute the Examiner’s finding that Goldstein teaches a method of
inhibiting tissue damage in a radiation sterilization process by using a
radioprotectant solution that includes a free radical scavenger. Final
Act. 5, 8; Goldstein ¶¶ 58–61. Appellant does not distinguish Goldstein’s
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substrate (human or animal tissue) from the substrate being irradiated in
Kristensen and the claimed method (a saccharide sensor). We note that both
references are concerned with inhibiting free-radical initiated cleavage of
amino acid sequences in proteins. Kristensen ¶¶ 69–71; Goldstein ¶ 12.
Responding to the Examiner’s findings regarding Goldstein,
Appellant does not argue that the effectiveness of sodium nitrate is limited to
temperatures of -30° C. or less. Reply Br. 3. Instead, Appellant argues that
Goldstein would have led a person of ordinary skill in the art to use
temperatures below the freezing point of water. Appeal Br. 5; Reply Br. 4.
Based on the teachings of Goldstein, we disagree.
As Appellant acknowledges, Goldstein’s teaching to carry out the
radiation sterilization at a cryogenic temperature is the disclosure of a
preferred embodiment. Appeal Br. 4; Goldstein ¶ 76. The Examiner is
correct that Goldstein discloses other embodiments in which the radiation
sterilization is carried out above the freezing point of the protectant solution.
Ans. 5; Goldstein ¶ 34. Specifically, Goldstein discloses:
In another aspect, the tissue is placed in the
cryopreservation solution, irradiated, and stored at reduced
temperature, but not cryopreserved. In this aspect, reduced
temperature storage is preferably at refrigeration temperatures
from about 0° C. to about 15° C. In another aspect, the tissue is
placed in the cryopreservation solution, irradiated, and directly
implanted without extended storage.
Goldstein ¶ 34. Although the Examiner’s Answer quotes extensively from
Goldstein paragraph 34 (Ans. 5), Appellant fails to address it in the Reply
Brief.
Goldstein’s teaching of a preferred embodiment involving cryogenic
temperatures does not amount to a teaching away from other disclosed
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embodiments involving temperatures above the freezing point of water.
Bayer Pharma AG v. Watson Labs., Inc., 874 F. 3d 1316, 1327 (Fed. Cir.
2017) (“[T]he teaching away inquiry does not focus on whether a person of
ordinary skill in the art would have merely favored one disclosed option
over another disclosed option.”); Merck & Co., Inc. v. Biocraft Labs., Inc.,
874 F.2d 804, 807 (Fed. Cir. 1989) (“[I]n a section 103 inquiry, ‘the fact that
a specific [embodiment] is taught to be preferred is not controlling, since all
disclosures of the prior art, including unpreferred embodiments, must be
considered,’” quoting In re Lamberti, 545 F.2d 747, 750 (CCPA 1976).).
Accordingly, we do not agree with Appellant’s argument that
Goldstein teaches away from the claimed methods, and we are not persuaded
that Appellant identifies reversible error in the Examiner’s decision to reject
claims 1 and 21 over Kristensen and Goldstein.
Dependent Claims 3–5 and 7–9
Appellant presents no arguments specifically directed to the
dependent claims separate from its arguments regarding independent claims
1 and 21. Accordingly, we sustain the Examiner’s rejections of the
dependent claims for the reasons discussed above regarding the independent
claims.
CONCLUSION
The Examiner’s rejections are affirmed.
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Application 14/728,442

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DECISION SUMMARY
In summary:
Claims
Rejected
35
U.S.C. §
Reference(s)/Basis Affirmed Reversed
1, 4, 5, 7–9,
21
103 Kristensen, Goldstein 1, 4, 5, 7–9,
21

3 103 Kristensen, Goldstein,
Tseng
3
Overall
Outcome
1, 3–5, 7–9,
21

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