Ex Parte Scott et al

Board of Patent Appeals and Interferences

Nov 2, 2010

11673287 (B.P.A.I. Nov. 2, 2010)

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.
11/673,287 02/09/2007 Mark D. Scott CBS-4533 2350
5409 7590 11/02/2010
SCHMEISER, OLSEN & WATTS
22 CENTURY HILL DRIVE
SUITE 302
LATHAM, NY 12110
EXAMINER
SAUCIER, SANDRA E
ART UNIT PAPER NUMBER
1651
MAIL DATE DELIVERY MODE
11/02/2010 PAPER
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.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte MARK D. SCOTT and ELISABETH MAURER
__________

Appeal 2010-006964
Application 11/673,287
Technology Center 1600
__________

Before DONALD E. ADAMS, LORA M. GREEN, and
STEPHEN WALSH, Administrative Patent Judges.

GREEN, Administrative Patent Judge.

DECISION ON APPEAL1
This is a decision on appeal under 35 U.S.C. § 134 from the
Examiner’s rejection of claims 26-33. We have jurisdiction under 35 U.S.C.
§ 6(b).

1 The two-month time period for filing an appeal or commencing a civil
action, as recited in 37 C.F.R. § 1.304, or for filing a request for rehearing,
as recited in 37 C.F.R. § 41.52, begins to run from the “MAIL DATE”
(paper delivery mode) or the “NOTIFICATION DATE” (electronic delivery
mode) shown on the PTOL-90A cover letter attached to this decision.
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Application 11/673,287

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STATEMENT OF THE CASE
Claim 262 is the only independent claim on appeal, and reads as
follows:
26. A platelet structure, comprising:
at least one modified platelet at a temperature below 20 ºC, each
modified platelet comprising a platelet and at least one polymerated
chemical, each polymerated chemical either comprising a polymer
covalently bonded directly to the platelet membrane of the platelet or
comprising the polymer and a linker molecule such that the linker molecule
is covalently bonded to the platelet membrane of the platelet and the
polymer is covalently attached to the linker molecule, the polymer of each
polymerated chemical of each modified platelet being independently
selected from the group consisting of polyethylene glycol (PEG) and a PEG
derivative, said at least one modified platelet not comprising a modification
of the platelet membrane of each platelet with a glycan-modifying agent.

The following grounds of rejection are before us for review:
I. Claims 26-33 stand rejected on the ground of nonstatutory
obviousness-type double patenting as being unpatentable over
claims 1 and 2 of U.S. Patent No. 6,669,465 B2 to Scott (issued
March 2, 2004).
II. Claims 26-29 stand rejected under 35 U.S.C. § 102(b) as being
anticipated by Scott WO 99/00145 (published January 7, 1999) or
Byun WO 97/28254 (published August 7, 1997).
III. Claims 26-29 and 31-33 stand rejected under 35 U.S.C. § 103(a) as
being rendered obvious by Scott WO 99/00145 or Byun WO
97/28254.

2 Claims 1-25 stand withdrawn from consideration. (App. Br. 1.)
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IV. Claims 26-29 and 31-33 stand rejected under 35 U.S.C. § 103(a) as
being rendered obvious by Scott US 6,699,465.
V. Claims 26-29 and 31-33 stand rejected under 35 U.S.C. § 103(a) as
being rendered obvious by Scott US 5,908,624 (issued June 1,
1999).
VI. Claim 30 stands rejected under 35 U.S.C. § 103(a) as being
rendered obvious by Scott US 6,699,465 or Scott US 5,908,624 or
Scott WO 99/00145 or Byun WO 97/28254 as combined with
Gulliksson.3
We reverse.
ISSUE
Has the Examiner established by a preponderance of the evidence that
the relied upon prior art teaches or suggests the claimed platelet composition
which is at a temperature below 20ºC?

FINDINGS OF FACT
FF1 As we conclude that all of the rejections on appeal turn on the same
issue, we will address all of the rejections together.
FF2 According to the Specification:
Transfusion of platelets (a commonly transfused cellular
component of blood) is a cornerstone of modern medical care
for a number of acute and chronic conditions characterized by
either excessive bleeding or insufficiency of endogenous
platelet production or function. Unlike red blood cells, which

3 Gulliksson et al., Storage of Platelets in Additive Solutions: Effects of
Phosphate, 78 VOX SANGUINIS 176-184 (2000).
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can be efficiently stored at 1 -6°C (mean 4°C), platelets are
irreversibly injured when temperatures repeatedly drop below
approximately 20°C for short periods of time or are kept at less
than 20°C for long periods of time. This injury is termed the
“platelet cold storage lesion”. Importantly, this platelet cold
storage lesion begins to occur even after brief exposure to
temperatures less than 20°C and is even seen in patients
undergoing surgery in which the temperature of the whole body
or of parts of the body is decreased to temperatures less than
20°C and leads to bleeding abnormalities.

(Spec. 1.)
FF3 The Specification teaches further:
[K]ey characteristics of this platelet cold storage lesion are: (1)
reversible to irreversible morphological change from a discoid
cell to spiculated spheres with protruding filopodia, depending
on time at temperatures less than 20°C; (2) irreversible
immune-independent microaggregation of platelets (i.e.,
increased cell:cell interaction); (3) membrane clustering of the
glycoprotein GPIb on the surface of platelets resulting in the
formation of a neoantigen; and (4) subsequent recognition and
phagocytosis by macrophages of the microaggregates and/or
neoantigen-expressing platelets upon transfusion into a
recipient. In addition, there is a significant reduction in
circulation half-life of chilled platelets introduced into a
recipient of the chilled platelets. As a consequence of this
platelet cold storage lesion, platelets must be stored at 20-24°C
(mean of 22°C) in order to maintain acceptable function and
viability in the transfused patient (see American Association of
Blood Banks (AABB) Technical Manual).

(Id. at 2.)
FF4 Thus, according to the Specification, “there is a need for a method for
storing platelets for more than five days such that the stored platelets have
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acceptable platelet functionality and viability after being introduced into a
patient.” (Id. at 4.)
FF5 Figure 4 of the Specification is reproduced below:

Figure 4 “contrasts mPEG grafted platelets with normal platelets with
respect to the respective platelets being chilled.” (Id. at 6.)
FF6 The Examiner’s statement of the rejection may be found at pages 3-8
of the Answer.
FF7 The Examiner acknowledges that none of the cited prior art references
teach that the modified platelets are at a temperature below 20°C.
FF8 With respect to the obviousness-double patenting rejecting, the
Examiner finds that claims 1 and 2 of US 6,699,465 are non-limiting with
respect to temperature, concluding that “it can be argued that claims 1 and 2
encompass the instantly claimed temperature limitations.” (Ans. 8.)
FF9 With respect to the remaining rejections, the Examiner finds:
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whether the modified platelet of the reference is at room
temperature or at 20°C or less, the essential characteristics of
the modified platelet would still be the same as the instantly
claimed platelet and such temperature variation does not make a
new or different composition.

(See id. at 5-7.)

PRINCIPLES OF LAW
The Examiner must consider all of the claim limitations in setting
forth a rejection over the prior art. See, e.g., In re Geerdes, 491 F.2d 1260,
1262-63 (CCPA 1974) (in considering grounds of rejection, “every
limitation in the claim must be given effect rather than considering one in
isolation from the others.”).

ANALYSIS
Appellants argue that, as acknowledged by the Examiner, none of the
references relied upon teach or suggest a temperature below 20ºC. (See,
e.g., App. Br. 8, 15, 17, 22, 26-27, 31, 32, and 37.) According to Appellants,
“a temperature of a platelet below 20 ºC covalently modified by PEG or a
PEG-derivative is patentably significant, because the combined effects of
temperature below 20 ºC and covalent modification of the platelets with
PEG or a PEG-derivative have a significant impact on fundamental
properties of a platelet, as discussed extensively in Appellants’
specification.” (Id. at 9.)
For example, Appellants argue, that as discussed in the Specification,
platelets are “irreversibly injured by an injury known as ‘platelet cold
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storage lesion’ even after brief exposure to temperatures less than 20 ºC.”
(Id.) Thus, Appellants assert, platelets must be stored at a temperature of
20-24ºC to maintain acceptable viability and function to the patient. (Id. at
10.)
We conclude that Appellants have the better position. Appellants
have provided evidence that the below 20ºC temperature limitation is critical
(see, e.g., above discussion, FF2, 3, and 5), and the Examiner has not
demonstrated by argument or evidence to the contrary.

CONCLUSION OF LAW
We conclude that the Examiner has not established by a
preponderance of the evidence that the relied upon prior art teaches or
suggests the claimed platelet composition which is at a temperature below
20ºC. We are thus compelled to reverse all of the appealed rejections.

REVERSED

cdc

SCHMEISER, OLSEN & WATTS
22 CENTURY HILL DRIVE
SUITE 302
LATHAM, NY 12110