Ex Parte Wada et al

Patent Trial and Appeal Board

Oct 11, 2018

14398321 (P.T.A.B. Oct. 11, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
14/398,321 10/31/2014
7055 7590 10/15/2018
GREENBLUM & BERNSTEIN, P.L.C.
1950 ROLAND CLARKE PLACE
RESTON, VA 20191
FIRST NAMED INVENTOR
Tamaki Wada
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.
P4661 l 3929
EXAMINER
CORDAS, EMILY ANN
ART UNIT PAPER NUMBER
1651
NOTIFICATION DATE DELIVERY MODE
10/15/2018 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):
gbpatent@gbpatent.com
greenblum.bernsteinplc@gmail.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte TAMAKI WADA, MASAKO DOI,
TAKESHI KIKUCHI, and EIJI KOBA Y ASHI 1
Appeal2017-009522
Application 14/398,321
Technology Center 1600
Before RICHARD M. LEBOVITZ, JOHN E. SCHNEIDER, and
RYAN H. FLAX, Administrative Patent Judges.
FLAX, Administrative Patent Judge.
DECISION ON APPEAL
This is a decision under 35 U.S.C. § 134(a) involving claims directed
to a method for preventing pulmonary embolism formation in cell
transplantation. Claims 11-22 are on appeal as rejected under 35 U.S.C.
§ 103(a). We have jurisdiction under 35 U.S.C. § 6(b).
We reverse.
1 Appellants identify the Real Party in Interest as "OTSUKA
PHARMACEUTICAL FACTORY, INC." Appeal Br. 3. Herein we
reference the Substitute Specification of Oct. 31, 2014 ("Spec."); the Final
Office Action of Sept. 20, 2016 ("Final Action"); the Appeal Brief of Feb.
14, 2017 ("Appeal Br."); the Examiner's Answer of Apr. 28, 2017
("Answer"); and Reply Brief of June 26, 2017 ("Reply Br.").
Appeal2017-009522
Application 14/398,321
STATEMENT OF THE CASE
Independent claim 11 is representative and is reproduced below:
11. A method for preventing pulmonary embolism formation
in cell transplantation, comprising administering a mammalian
cell suspension comprising mammalian cells and trehalose or its
derivative, or salt thereof, and not comprising serum albumin,
through a blood vessel.
Appeal Br. 13 (Claims Appendix).
The following rejection is appealed:
Claims 11-22 stand rejected under 35 U.S.C. § I03(a) over March2
and Roser. 3 Final Action 3.
DISCUSSION
An examiner bears the initial burden of presenting a prima
facie case of obviousness. Once the examiner establishes a prima
facie case of obviousness, the burden shifts to the applicant to
rebut that case. However, once the applicant has come forward
with rebuttal evidence, the examiner must consider the totality of
the evidence to determine whether the obviousness rejection
should stand.
In re Huai-Hung Kao, 639 F.3d 1057, 1066 (Fed. Cir. 2011) (citations
omitted). A proper § 103 analysis requires "a searching comparison of the
claimed invention-including all its limitations-with the teaching of the
prior art." In re Ochiai, 71 F.3d 1565, 1572 (Fed. Cir. 1995). "[D]ependent
claims are nonobvious if the independent claims from which they depend are
nonobvious." In re Fritch, 972 F.2d 1260, 1266 (Fed. Cir. 1992).
The Examiner determined that March disclosed intravenously and
intra-arterially administering stem cells therapeutically and that, to overcome
2 WO 2010/048628 Al (published Apr. 29, 2010) ("March").
3 US 2005/0163750 Al (published July 28, 2005) ("Roser").
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Application 14/398,321
the problem of cellular aggregation, mixing the cells with a modifying agent
that prevents aggregation ( and that such a mixture does not include serum
albumin). Final Action 3--4 (citing March ,r,r 1, 4, 9, 13, 15, 34--36, 40, 41,
45, 65, 111, 137, 147, 157,202,207,208,213,234,264). Noting that
among the several modifying agents discussed in March, the reference does
not disclose using trehalose, the Examiner cited Roser for such a teaching.
Id. at 4 (citing Roser ,r,r 6, 7, 12, 18, 19, 20, 21, 35--42).
Appellants argue that Roser does not suggest that, when suspending
cells for therapeutic administration, trehalose is a modifying agent to
mitigate cell aggregation. Appeal Br. 10-11. Appellants point to Roser's
paragraph 38 (Example 2), which discusses an analysis of rat red blood cells
treated with trehalose to ascertain whether trehalose prevented
agglomeration and states, "[ u ]nfixed cells agglutinated in trehalose and
needed the addition of I/5th volume of Phosphate-buffered saline before
being processed further." Roser ,r 38. "Unfixed cells" refers to cells not
fixed in either 1 % formaldehyde or 0.5% glutaraldehyde and resuspended in
either 10% trehalose or 0.12 mM sodium azide or CDP. Id. ,r 36. Fixed
cells, that were so treated, were not processed further. Id. ,r 37. Unfixed
cells were observed to agglutinate in trehalose, which Appellants identify as
meaning aggregate, such that the skilled artisan would recognize that
aggregation was not prevented (but was potentially caused) by the presence
of trehalose, and was only prevented by the addition of phosphate-buffered
saline. Id. ,r 38.
While the Examiner is correct that Roser discloses using trehalose to
prevent aggregation and March discloses preventing aggregation of stem
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Application 14/398,321
cells using any effective agent (see portions cited by Examiner, identified
supra), we are persuaded that the skilled artisan would not have combined
Roser and March to achieve the claimed invention. Roser is focused on
preventing aggregation when substances are frozen and thawed or
dehydrated and rehydrated, which are disclosed to be conditions that may
cause substances to aggregate. Roser discloses that trehalose can serve as an
anti-aggregation agent for many substances, including red blood cells.
Roser ,r 12. However, Roser suggests that trehalose is not necessarily
effective at preventing aggregation in natural, living cells, i.e., unfixed cells;
to the contrary, Roser suggests that trehalose may cause aggregation
(agglutination) in such cells. Id. ,r 38. In this regard, the claims require
administration of living cells. While Roser teaches that trehalose will
prevent or mitigate aggregation in cells fixed with formaldehyde or
glutaraldehyde, which are not cells that would be therapeutically injected
into a patient, it teaches that "[u]nfixed cells agglutinate[] in trehalose." Id.
,r,r 36-42.
"While absolute certainty is not necessary to establish a reasonable
expectation of success, there can be little better evidence negating an
expectation of success than actual reports of failure." Boehringer Ingelheim
Vetmedica, Inc. v. Schering-Plough Corp., 320 F.3d 1339, 1354 (Fed. Cir.
2003). Thus, we conclude that a skilled artisan having both March and
Roser before her would not be motivated to use Roser's trehalose as a
modifying agent in March's processes to prevent aggregation in stem cells
for injection. Such a skilled artisan would have no reasonable expectation
that adding trehalose to March's stem cell suspension would prevent the
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Application 14/398,321
cells from aggregating, but would expect just the opposite based on Roser,
as discussed above.
SUMMARY
The obviousness rejection under 35 U.S.C. § 103(a) is reversed.
REVERSED
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