Ex Parte Hess et al

Board of Patent Appeals and Interferences

Jul 10, 2012

11060026 (B.P.A.I. Jul. 10, 2012)

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.
11/060,026 02/17/2005 John R. Hess 1-17521 2360
1678 7590 07/11/2012
MARSHALL & MELHORN, LLC
FOUR SEAGATE - EIGHTH FLOOR
TOLEDO, OH 43604
EXAMINER
SAUCIER, SANDRA E
ART UNIT PAPER NUMBER
1657
MAIL DATE DELIVERY MODE
07/11/2012 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 JOHN R. HESS and TIBOR J. GREENWALT
__________

Appeal 2010-011844
Application 11/060,026
Technology Center 1600
__________

Before ERIC GRIMES, STEPHEN WALSH, and
JACQUELINE WRIGHT BONILLA, Administrative Patent Judges.

BONILLA, Administrative Patent Judge.

DECISION ON REQUEST FOR REHEARING
Appellants have requested rehearing of the decision entered April 16,
2012 (“Decision”), affirming the rejection of claim 88 for lack of written
description, the rejection of claims 82, 83, and 86-92 as anticipated, and the
rejection of claims 82-96 for obviousness. The request for rehearing is
denied.
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DISCUSSION
In particular, Appellants request reconsideration of our affirmance of
the rejections of:
(I) claims 82, 83, and 86-92 as being anticipated under 35 U.S.C.
§ 102(b) by Wood
1
based on an interpretation of the claim
phrase “sufficient to establish and maintain … a reaction
equilibrium in the red blood cell that favors glycolysis over
synthesis of [2,3-DPG], thereby generating a net gain in [ATP]
with respect to the reaction equilibrium during the storage
period,” and
(II) claims 82-96 under 35 U.S.C. § 103(a) as obvious over Hess.2
I. Rejection of claims 82, 83, and 86-92 as being anticipated by Wood
Appellants assert that the Board misinterprets the claim phrase
“sufficient to establish and maintain … a reaction equilibrium in the red
blood cell that favors glycolysis over synthesis of [2,3-DPG], thereby
generating a net gain in [ATP] with respect to the reaction equilibrium
during the storage period,” recited in claims 82 and 83 (Req. Reh‟g. 2-4).
As noted in our Decision, we interpret this phrase to refer to an
“equilibrium” that is established at some point in time “during the storage
period,” where a net gain of ATP occurs (as generated by the red blood cells
stored in the composition) after the equilibrium is reached (Decision 11).

1
L.A. Wood and E. Beutler, The Effect of Periodic Mixing on the
Preservation of 2,3-Diphosphoglycerate (2,3-DPG) Levels in Stored Blood,
42 BLOOD 17-25 (1973).
2
Hess et al. (U.S. Pat. No. 6,447,987 B1, issued Sep. 10, 2002).
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Appellants argue that the Board misapprehends what is meant by
“generating a net gain in [ATP] with respect to the reaction equilibrium
during the storage period” in the claim phrase above (Req. Reh‟g. 3).
Appellants assert that the term “net gain” means “a true profit, not simply an
increase in ATP production” (id.).
In our Decision, we previously found that Figure 1C and Table 1 in
Wood show that BAGPM achieves the recited equilibrium after about 7 days
of storage, and after that point, net levels of ATP increase (Decision 11). As
stated by Wood, “ʻ [i]n the mixed BAGPM bag levels, the ATP fell to low
levels at 7 days and then steadily increased throughout the rest of the storage
period‟” (id.) In other words, after establishing an equilibrium in the red
blood cells (at approximately 7 days), the equilibrium favored glycolysis
over 2,3-DPG synthesis in a manner sufficient to generate a “net gain” in
ATP production by the red blood cells during the rest of the storage period,
i.e., from 7 to 42 days.
Appellants argue now, however, that Figure 1C in Wood does not
show a “net gain” in ATP as recited in the claims, i.e., a true profit of ATP,
because “ATP production is far below what it was originally” (Req. Reh‟g.
3). Appellants note that “[l]ooking at Fig. 1C of Wood, it appears as if
initially the ATP production is about 45 µmol ATP/gm Hg [sic, Hb] but,
even with mixing, never creeps above about 23 µmol ATP/gm Hg [sic] at
any point during the rest of the time shown” (id.). In other words, while
Figure 1C shows that ATP concentrations increase after 7 days of storage,
the figure does not show that ATP concentration at any point (e.g., days 7-
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42) after the initial start point exceeds the concentration observed at the
initial starting point (day 0).
Appellants allege that support for their claim interpretation “is
inherent throughout the application” (id. at 4). Appellants also refer to
Figure 1A in the Specification (id. at 3-4). Figure 1A depicts ATP
concentration as a percentage “of initial,” and shows that ATP
concentrations are higher than initial levels (i.e., higher than 100%) for at
least the first 2-4 weeks of storage. According to Appellants, “[a]t any point
above 100%, the cells being stored are showing a net gain, or true profit, in
ATP at that point” (id. at 4).
The Board gives claims “their broadest reasonable interpretation
consistent with the specification.” In re Hyatt, 211 F.3d 1367, 1372 (Fed.
Cir. 2000). Notwithstanding what is shown in Figure 1A of the
Specification, we disagree that a broadest reasonable interpretation of the
claim phrase at issue, consistent with the specification, leads to the
interpretation asserted by Appellants. While Appellants focus on the “net
gain” language, this language cannot be read in isolation, but rather must be
read as it appears in the claim as a whole.
The entire claim phrase at issue recites “sufficient to establish and
maintain during a storage period a reaction equilibrium in the red blood cell
that favors glycolysis over synthesis of [2,3-DPG], thereby generating a net
gain in [ATP] with respect to the reaction equilibrium during the storage
period.” (See, e.g., claim 82 (emphasis added).) The broadest reasonable
interpretation of this phrase consistent with the Specification as a whole is
that the composition is capable of establishing and maintaining a reaction
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equilibrium in a red blood cell, where the cell generates a net gain in ATP
“with respect to the reaction equilibrium,” i.e., an equilibrium in the cell that
favors glycolysis over synthesis of 2,3-DPG.
The claim language indicates that an equilibrium is established at
some point in time “during the storage period,” at which time a “net gain” in
ATP occurs, i.e., more ATP is generated by the red blood cell than used by
the red blood cell. Nothing in the claim language itself suggests that the “net
gain” in ATP relates to an ATP concentration initially present in the starting
material. In addition, notwithstanding what is shown in Figure 1A, nothing
in the Specification indicates that the claim phrase language should be
limited in that manner. Figure 1A relates to Example 1, which does not
suggest the importance of the initial starting concentration in relation to the
claim language (Spec. 21-24; see, e.g., 23, ll. 16-22). By contrast, the
Specification describes a “novel pH modulating system … which is
sufficient to maintain a pH in the intracellular space sufficient to drive the
internal cell equilibrium toward glycolysis and away from the ATP-
consuming production of 2,3-DPG.” This description supports our claim
interpretation discussed above, and points to nothing in relation to an ATP
concentration of the starting material.
Thus, we decline to adopt Appellants‟ claim interpretation, and find
our original interpretation of the phrase to be correct (Decision 11).
Appellants also urge us, as needed, to amend claims to recite “generating a
true profit net gain” or “generating a total net gain” in ATP (Req. Reh‟g. 4).
Even assuming the Specification provides written description support for the
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suggested language, the Board cannot enter claim amendments during an
appeal, much less in response to a request for rehearing.
II. Rejection of claims 82-96 as obvious over Hess
Regarding the obviousness rejection based on Hess, Appellants
essentially argue, for the first time before us, that the compositions recited in
the claims “provide superior results compared with the myriad of other
choices and possibilities proposed by Hess‟s earlier „987 patent” (Req.
Reh‟g. 7). Appellants also assert that “[t]hese superior results were
overlooked by the Board in the Decision” (id). Appellants do not point out,
however, where Appellants have previously raised such arguments, or the
new evidence cited by Appellants in the form of an additional Hess
publication (id. at 8), in their Briefs.
As stated in 37 C.F.R. § 41.52(a)(1):
The request for rehearing must state with particularity the points
believed to have been misapprehended or overlooked by the Board.
Arguments not raised in the briefs before the Board and evidence not
previously relied upon in the brief and any reply brief(s) are not
permitted in the request for rehearing . . .
Here, Appellants‟ Request for Rehearing does not point to any argument,
evidence of record, or legal authority, that was before us in the Briefs that
we overlooked or misapprehended in reaching the conclusions set forth in
the Decision.
SUMMARY
We are not persuaded that the Decision has misapprehended or
overlooked any argument or point of law, or that Appellants have presented
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any grounds for rehearing. For the reasons discussed above, we decline to
modify our original decision entered April 16, 2012.

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).

REHEARING DENIED

cdc