Ex Parte Dumont et al

Patent Trial and Appeal Board

Dec 4, 2012

10377524 (P.T.A.B. Dec. 4, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte LARRY JOE DUMONT and RAYMOND PAUL GOODRICH
__________

Appeal 2012-000241
Application 10/377,524
Technology Center 1600
__________

Before ERIC GRIMES, MELANIE L. McCOLLUM, and JEFFREY N.
FREDMAN, Administrative Patent Judges.

GRIMES, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to blood
platelet-containing products, which have been rejected for obviousness. We
have jurisdiction under 35 U.S.C. § 6(b). We affirm.
STATEMENT OF THE CASE
The Specification discloses “treating a fluid or other material to
inactivate at least some of the microorganisms and white cells which may be
present therein” (Spec. 5: 12-13), such as by mixing the fluid with an
endogenous photosensitizer and exposing the fluid to photoradiation (id. at
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5: 16-22). “Examples of such endogenous photosensitizers are alloxazines
such as 7,8-dimethyl-10-ribityl isoalloxazine (riboflavin)” (id. at 8: 8-9).
Claims 67, 69, 70, 72-74, 76, 77, 79, 80, 82, 83, 85, 86, 88-90, and 92-
95 are on appeal. Claims 67, 70, and 77 are representative and read as
follows:
67. A fluid containing a blood product for subsequent reinfusion into
a donor/patient consisting essentially of:
platelets collected from a donor/patient; and
a platelet additive storage and/or pathogen reduction solution
consisting essentially of
an endogenous alloxazine;
saline;
tri-sodium citrate; and
sodium acetate;
wherein the endogenous alloxazine does not need to be
removed from the fluid to be reinfused.

70. A fluid containing a blood product for subsequent reinfusion into
a donor/patient consisting essentially of:
platelets collected from a donor/patient; and
a platelet additive storage and/or pathogen reduction solution
consisting essentially of
an endogenous alloxazine;
saline;
potassium chloride;
tri-sodium citrate; and
sodium phosphate;
wherein the endogenous alloxazine does not need to be
removed from the fluid to be reinfused.

77. A fluid containing a blood product for subsequent reinfusion into
a donor/patient consisting essentially of:
platelets collected from a donor/patient; and
a platelet additive storage and/or pathogen reduction solution
consisting essentially of
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an endogenous alloxazine;
saline;
potassium chloride;
magnesium chloride;
tri-sodium citrate;
sodium phosphate;
sodium acetate;
glucose; and
maltose;
wherein the endogenous alloxazine does not need to be
removed from the fluid to be reinfused.

The claims stand rejected under 35 U.S.C. § 103(a) as follows:
• Claims 67 and 69 based on Carmen,1 Kuratomi,2 Tsugita,3
Gulliksson,4 Wagner,5 and Proctor6 (Answer 5);
• Claims 70 and 72 based on Carmen, Kuratomi, Tsugita, Wagner,
Proctor, and Holme (1992)7 (Answer 11);
• Claims 70, 72, and 73 based on Carmen, Kuratomi, Tsugita,
Wagner, Proctor, Holme (1992), Holme ‘971,8 and Hock9 (Answer 14);

1 Carmen et al., WO 97/18844, May 29, 1997.
2 Kuratomi et al., Photodynamic Action of Lumiflavin on the Template DNA
of RNA polymerase, 72 FEBS LETTERS 295-298 (1976).
3 Tsugita et al., Photosensitized Inactivation of Ribonucleic Acids in the
Presence of Riboflavin, 103 BIOCHIM. BIOPHYS. ACTA 360-363 (1965).
4 Gulliksson et al., Buffy-Coat-Derived Platelet Concentrates Prepared from
Half-Strength Citrate CPD and CPD Whole-Blood Units, 68 VOX
SANGUINIS 152-159 (1995).
5 Wagner et al., Differential Sensitivities of Viruses in Red Cell Suspensions
to Methylene Blue Photosensitization, 34 TRANSFUSION 521-526 (1994).
6 Proctor et al., US 2,832,689, Apr. 29, 1958.
7 Holme, Effect of Additive Solutions on Platelet Biochemistry, 18 BLOOD
CELLS 421-430 (1992).
8 Holme et al., US 5,487,971, Jan. 30, 1996.
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• Claims 74, 76, 77, 79, 90, 92, 93, and 95 based on Carmen,
Kuratomi, Tsugita, Wagner, Proctor, and Shimizu10 (Answer 16);
• Claims 74, 76, 77, 79, 90, and 92-95 based on Carmen, Kuratomi,
Tsugita, Wagner, Proctor, Shimizu, Lin ‘742,11 and Livne12 (Answer 20-21);
• Claims 80 and 82 based on Carmen, Kuratomi, Tsugita, Wagner,
Proctor, and Holme (1987)13 (Answer 22); and
• Claims 83, 85, 86, 88, and 89 based on Carmen, Kuratomi, Tsugita,
Wagner, Proctor, and Lin (WO)14 (Answer 25).
I.
Issue
The Examiner has rejected claims 67 and 69 as obvious based on
Carmen, Kuratomi, Tsugita, Gulliksson, Wagner, and Proctor (Answer 5).
The Examiner finds that Carmen discloses “a generic composition
comprising a biological fluid, a pathogen photo-inactivating agent and an
additive solution,” where the biological fluid can be a platelet concentrate
and a preferred photo-inactivating agent is methylene blue (id. at 6-7). The
Examiner finds that Kuratomi and Tsugita teach that riboflavin is more

9 Hock, US 5,688,919, Nov. 18, 1997.
10 Shimizu et al., First Autoclave-Sterilized Platelet-Additive Solution
Containing Glucose with a Physiological pH for the Preparation of Plasma-
Poor Platelet Concentrates, 62 VOX SANG. 87-93 (1992).
11 Lin et al., US 5,908,742, June 1, 1999.
12 Livne et al., Volume-Regulating Behavior of Human Platelets, 131 J. OF
CELLULAR PHYS. 354-363 (1987).
13 Holme et al., Improved in vivo and in vitro Viability of Platelet
Concentrates Stored for Seven Days in a Platelet Additive Solution, 66
BRITISH J. OF HEMATOLOGY 233-238 (1987).
14 Lin et al., WO 96/14740, May 23, 1996.
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effective than methylene blue as a photosensitizer for inactivating pathogens
(id. at 8). The Examiner finds that Gulliksson discloses an additive storage
solution that includes the components recited in claim 67, which increases
platelet stability during storage (id. at 9).
The Examiner concludes that it would have been obvious to use
Gulliksson’s additive solution in Carmen’s composition in order to stabilize
platelets, and to substitute riboflavin for Carmen’s methylene blue based on
Kuratomi and Tsugita (id. at 10). The Examiner finds that a person of
ordinary skill in the art would have had a reasonable expectation of success
based on Wagner and Proctor, who teach use of photosensitizing agents such
as methylene blue and riboflavin in a cell-containing environment (id. at 9,
11).
Appellants contend that it would not have been obvious to substitute
an endogenous alloxazine for the methylene blue in Carmen’s composition
because Carmen “is specifically directed to methods and systems for
filtering out activated photosensitizer from the blood product” and an
endogenous alloxazine would not have to be removed (Appeal Br. 12).
Appellants also contend that Kuratomi and Tsugita would not have made it
obvious to substitute riboflavin for methylene blue because their results were
obtained in a cell-free environment and those skilled in the art would not
have extrapolated those teachings to a cellular environment, as claimed (id.
at 13-14), and Wagner and Proctor do not make up for this deficiency (id. at
14).
The issue with respect to this rejection is: Does the evidence of
record support the Examiner’s conclusion that the cited references would
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have provided a reason to combine the elements of the claimed composition
with a reasonable expectation of success?
Findings of Fact
1. Carmen discloses “inactivating potential pathogens in biological
fluids such as blood or blood components . . . by adding photoactivating
agents and separating them after photoactivation” (Carmen, abstract).
2. Carmen discloses that “a biological fluid is depleted of a portion of
fluid, e.g., plasma, and an inactivating agent (such as a photoactive agent)
and an additive solution are added to the biological fluid before inactivation
is carried out” (id. at 3: 6-9).
3. Carmen discloses that the biological fluid includes “blood . . . one
or more blood components, such as platelets suspended in plasma, plasma
concentrate (PC),” etc. (id. at 4: 5-10).
4. Carmen discloses that a “photoactive agent is a material that is
capable of undergoing a chemical reaction when activated by radiation, e.g.,
light. . . . The photoactive agent is capable of inactivating a wide variety of
undesirable matter, particularly potential pathogens.” (Id. at 4: 18 to 5: 3.)
5. Carmen discloses that methylene blue is a preferred photoactive
agent (id. at 5: 6).
6. Carmen discloses that a “variety of suitable additive solutions are
commercially available and/or are described in the literature” (id. at 6: 6-8).
7. Carmen discloses that “[i]llustrative additive solutions include
saline solutions, e.g., comprising about 0.9% saline” (id. at 6: 12-13).
8. Kuratomi discloses that “[b]acteriostatic actions of riboflavin on
some organisms have been observed in light” (Kuratomi 295, left col.).
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9. Kuratomi discloses that, after exposure to light, riboflavin inhibits
the activity of RNA polymerase as a result of inactivating the template DNA
(id. at 296, left col. and Table 2).
10. Tsugita discloses that “adenine as well as guanine was photo-
oxidized by visible light in the presence of riboflavin” (Tsugita 360-361).
11. Tsugita discloses that riboflavin, in the presence of light, was
more efficient than methylene blue in inactivating the amino acid acceptor
activity of soluble RNA (“s-RNA”) from E. coli (id. at 361, Figs. 1 and 2;
362).
12. Tsugita discloses that “[p]hotosensitized inactivations of
infectious TMV [tobacco mosaic virus] and its RNA were also found in the
presence of riboflavin or methylene blue” (id. at 362).
13. Tsugita discloses that, after exposure to light, 1.25 x 10-5 M
riboflavin produced 0% remaining TMV activity, while the same
concentration of methylene blue under the same conditions produced 25%
remaining TMV activity (id. at 362, Table I).
14. Gulliksson discloses a platelet additive solution (Test solution C,
also referred to as PAS-2) that includes saline (sodium chloride),
trisodiumcitrate-2-hydrate, and sodium acetate (Gulliksson 154, Table 1).
15. Gulliksson discloses that its results suggest that it should be
possible to store plasma concentrates (PCs) in 70% PAS-2 for 7 days and
that “when the storage period exceeds 5 days, the improved maintenance of
pH makes PAS-2 superior to saline” (id. at 158, right col.).
16. Wagner discloses that one recently studied method “uses the
phenothiazine photosensitizer methylene blue (MB) for virus inactivation in
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red cells. The virucidal activity of MB phototreatment has long been
recognized.” (Wagner 521, right col., footnotes omitted.)
17. Wagner discloses extending previous MB studies “to conditions
that inactivate extracellular HIV-1 and Sindbis virus, a model virus with
distant sequence and structural relationships to HCV” (id. at 522, left col.).
Analysis
We agree with the Examiner that the cited references support a prima
facie case of obviousness. Carmen discloses adding a photoactivating agent
(e.g., methylene blue) and an additive solution to a biological fluid such as
plasma concentrate in order to inactivate potential pathogens by exposure to
light. Kuratomi discloses that riboflavin, in combination with light, has
bacteriostatic activity. Tsugita discloses that riboflavin is a more potent
photoactive agent than methylene blue in inactivating E. coli soluble RNA
and in inactivating tobacco mosaic virus. We agree with the Examiner that,
based on these teachings, it would have been obvious to use riboflavin as a
photoactive agent in place of the methylene blue in Carmen’s composition.
In addition, Gulliksson discloses that its PAS-2 platelet additive
solution should allow storage of platelet concentrates for up to 7 days, and
that PAS-2 is superior to saline. Based on this teaching, it would have been
obvious to use Gulliksson’s PAS-2 as the additive solution in Carmen’s
composition. The prior art therefore would have made obvious a
composition consisting essentially of the components recited in claim 67.
Appellants argue, however, that Kuratomi and Tsugita only show that
“riboflavin may be superior to methylene blue (based on Tsugita as cited at
page 297, right column) in the photosensitized inactivation of nucleic acid in
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a cell-free environment” (Appeal Br. 13), but “there is nothing in Kuratomi
or Tsugita that would enable one skilled in the art to extrapolate from the
teachings of using riboflavin in a cell-free environment to Applicants[’]
claimed invention of using riboflavin in a cellular environment” (id. at 14).
Appellants also argue that Wagner “adds nothing additional to the rejection,
as the Examiner’s primary reference Carmen teaches that methylene blue is
an effective photoinactivator of viruses in a cellular environment” (id.).
This argument is unpersuasive. Kuratomi states that riboflavin, in
combination with light, has been observed to have bacteriostatic action on
some organisms (FF 8), thus providing evidence that its activity is not
restricted to extracellular molecules. As Appellants pointed out, Carmen
discloses that methylene blue is active against viruses in a cellular
environment, and Tsugita provides evidence that riboflavin has antiviral
activity that is superior to that of methylene blue (FFs 11, 13). The
references therefore provide an adequate basis for reasonably expecting that,
like methylene blue, riboflavin would also provide antiviral activity in a
cellular environment. Appellants have pointed to no evidence showing that
the antiviral activity of riboflavin is limited to cell-free environments.
Appellants also argue that Carmen “is specifically directed to methods
and systems for filtering out activated photosensitizer from the blood
product . . . ‘since the material and/or its byproducts is “foreign” to the
recipient’s system, and could cause an adverse result’” (Appeal Br. 12,
quoting Carmen 2: 13-14).
This argument is unpersuasive. As discussed above, the cited
references provide a reasonable expectation of successfully substituting
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riboflavin for the methylene blue that is preferred by Carmen. The fact that
riboflavin, in addition to being a more potent photoactive agent than
methylene blue, would also not be foreign to the recipient’s system and less
likely to cause an adverse result, only provides an additional reason to make
the substitution proposed by the Examiner.
Finally, Appellants argue that “there is no teaching or suggestion in
Gulliksson that the same components that are known to stabilize platelets in
a storage solution could also be used in a pathogen reduction solution”
(Appeal Br. 15). This argument is unpersuasive because Carmen discloses
that any of a variety of additive solutions, including saline, can be used in its
composition. Gulliksson discloses that its platelet additive solution can be
used in place of saline and provides superior results (FFs 6, 7), and therefore
would have made obvious the substitution of its PAS-2 for Carmen’s saline
solution.
Conclusion of Law
The evidence of record supports the Examiner’s conclusion that the
cited references would have provided a reason to combine the elements of
the composition of claim 67 with a reasonable expectation of success. Claim
69 was not argued separately and therefore falls with claim 67. 37 C.F.R.
§ 41.37(c)(1)(vii).
II.
Issue
The Examiner has rejected claims 70 and 72 as obvious based on
Carmen, Kuratomi, Tsugita, Wagner, Proctor, and Holme (1992) (Answer
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11). The Examiner has also rejected claims 70, 72, and 73 as obvious based
on Carmen, Kuratomi, Tsugita, Wagner, Proctor, Holme (1992), Holme
‘971, and Hock (Answer 14). The same issue is dispositive for both
rejections.
The Examiner relies on Carmen, Kuratomi, Tsugita, Wagner, and
Proctor for the same teachings discussed above with respect to claim 67
(Answer 11-12). The Examiner finds that “Holme (1992) teaches the
platelet additive solution PSM-1-pH (NaCl (in water this is saline), KCl, tri-
sodium citrate and sodium phosphate)” (id. at 12). The Examiner concludes
that it would have been obvious to modify Carmen’s composition to
substitute riboflavin for methylene blue (id. at 13-14) and to use the additive
solution taught by Holme (1992) with “a reasonable expectation that the
additive solution taught by Holme (1992) would successfully preserve a
fluid having platelets because he discloses data demonstrating this
stabilization” (id. at 13).
Appellants contend that “[t]here is no indication in Holme (1992) or
the other references that the storage solution set forth in these claims will
effectively survive the addition of an alloxazine” (Appeal Br. 16).
Appellants also contend that Holme (1992) teaches that “PSM-1 is not an
optimal choice for storage of platelets. Therefore, one skilled in the art
would not think to add riboflavin to it to produce Applicants[’] claimed
invention” (id.).
The issue with respect to this rejection is: Does the evidence of
record support the Examiner’s conclusion that the cited references would
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have provided a reason to combine the elements of the composition of claim
70 with a reasonable expectation of success?
Additional Findings of Fact
18. Holme (1992) discloses that “[s]everal glucose-free storage media
have been described in the literature (Table 1). One has recently been
described by Murphy et al., the PSM-1-pH” (Holme (1992) at 424).
19. Holme (1992) discloses that PSM-1-pH contains NaCl, KCl,
NaH2PO4, and Na3citrate (id. at 423, Table 1).
20. Holme (1992) discloses “it was found that there was some loss of
posttransfusion viability with storage in PSM-1 for 5 days as compared to
storage in the control medium (CPD-plasma)” (id. at 424).
21. Holme (1992) discloses that “[i]n our laboratory . . . a significant
decrease in platelet adenine nucleotides was observed with storage in the
PSM-1 as compared to storage in plasma” (id.).
Analysis
We agree with the Examiner that the cited references support a prima
facie case of obviousness. As discussed above in reference to claim 67,
Carmen, Kuratomi, Tsugita, and Wagner would have made it obvious to a
person of ordinary skill in the art to use riboflavin as a photoactive agent in
place of the methylene blue in Carmen’s composition. Holme (1992)
discloses that PSM-1-pH was a known platelet storage solution that
contained the components recited in claim 70. This teaching, in combination
with Carmen’s disclosure that any of a variety of additive solutions,
including saline, were suitable for use in its composition, would have
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provided a reason for a skilled worker to use PSM-1-pH as the additive
solution in Carmen’s composition.
Appellants argue that “[t]here is no indication in Holme (1992) or the
other references that the storage solution set forth in these claims will
effectively survive the addition of an alloxazine” (Appeal Br. 16).
This argument is not persuasive. As discussed above with respect to
claim 67, Carmen discloses that any of a variety of additive solutions can be
used in combination with a photoactive compound in its composition.
Appellants have pointed to no evidence to show that a skilled worker would
have considered the PSM-1 solution disclosed by Holme (1992) to be
unsuitable for use in Carmen’s composition, or that the substitution of
riboflavin for methylene blue would have affected the choice of additive
solution.
Appellants also argue that Holme (1992) teaches that PSM-1 causes
some loss of posttransfusion viability after 5 days’ storage, compared to a
control medium, as well as a significant decrease in adenine nucleotides with
storage (Appeal Br. 16). Appellants argue that “[t]his teaching suggests that
PSM-1 is not an optimal choice for storage of platelets. Therefore, one
skilled in the art would not think to add riboflavin to it to produce
Applicants[’] claimed invention.” (Id.)
This argument is also unpersuasive. Although Holme (1992) notes
“some loss of posttransfusion viability with storage in PSM-1 for 5 days”
(FF 20), which correlated with a decrease in adenine nucleotides, Holme
(1992) does not characterize PSM-1 as unsuitable for use in storing platelets.
Thus, Holme (1992) would not have led a skilled worker to expect that
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PSM-1 would be unsuitable for use in the composition disclosed by Carmen.
PSM-1 need not have been “an optimal choice for storage of platelets”
(Appeal Br. 16) in order for it to have been an obvious choice. See In re
Fulton, 391 F.3d 1195, 1200 (Fed. Cir. 2004) (“[T]he question is whether
there is something in the prior art as a whole to suggest the desirability, and
thus the obviousness, of making the combination, not whether there is
something in the prior art as a whole to suggest that the combination is the
most desirable combination available.” (citation omitted)).
Conclusion of Law
The evidence of record supports the Examiner’s conclusion that
Carmen, Kuratomi, Tsugita, Wagner, Proctor, and Holme (1992) would have
provided a reason to combine the elements of the composition of claim 70
with a reasonable expectation of success. We therefore affirm the rejection
of claim 70 based on Carmen, Kuratomi, Tsugita, Wagner, Proctor, and
Holme (1992), as well as the rejection based on Carmen, Kuratomi, Tsugita,
Wagner, Proctor, Holme (1992), Holme ‘971, and Hock. Claims 72 and 73
fall with claim 70 because they were not argued separately. 37 C.F.R.
§ 41.37(c)(1)(vii).
III.
Issue
The Examiner has rejected claims 74, 76, 77, 79, 90, 92, 93, and 95 as
obvious based on Carmen, Kuratomi, Tsugita, Wagner, Proctor, and Shimizu
(Answer 16). We will focus our analysis on claim 77.
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The Examiner has also rejected claims 74, 76, 77, 79, 90, and 92-95 as
obvious based on Carmen, Kuratomi, Tsugita, Wagner, Proctor, Shimizu,
Lin ‘742, and Livne (Answer 20-21). The same issue is dispositive with
respect to both rejections.
The Examiner relies on Carmen, Kuratomi, Tsugita, Wagner, and
Proctor for the same teachings discussed above with respect to claim 67
(Answer 17). The Examiner finds that “Shimizu teaches Seto additive
solution which comprises NaCl, KCl, MgCl2, . . . NaH2PO4, Na2HPO4, Na
acetate, Na3citrate (tri-sodium citrate), maltose and glucose” (id.).15 The
Examiner concludes that it would have been obvious to modify Carmen’s
composition to substitute riboflavin for methylene blue (id. at 19-20) and to
use the additive solution taught by Shimizu with “a reasonable expectation
that the additive solution taught by Shimizu would successfully preserve a
fluid containing platelets because he discloses data demonstrating this
stabilization” (id. at 19).
Appellants contend that there is no teaching or suggestion that
alloxazine could be added to Shimizu’s solution (Appeal Br. 18). Appellants
also contend that Shimizu teaches that its Seto solution causes platelets to be
sensitive to extrinsic agonists and “[f]rom this teaching, one skilled in the art
would not think to add riboflavin to Seto solution for fear of causing the
platelets to develop even greater sensitivity” (id.).

15 The Examiner also includes sodium gluconate in the components of the
Seto solution (Answer 17) but this finding is not supported by the reference.
Sodium gluconate is a component of Shimizu’s AR solution (Shimizu 88,
Table 1) but not its Seto solution.
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The issue with respect to this rejection is: Does the evidence of
record support the Examiner’s conclusion that the cited references would
have provided a reason to combine the elements of the composition of claim
77 with a reasonable expectation of success?
Additional Findings of Fact
22. Shimizu discloses modification of a pre-existing platelet-additive
solution (AR solution) by addition of glucose and maltose and replacement
of sodium gluconate with sodium phosphate to yield a “new platelet-additive
solution (termed Seto solution)” (Shimizu 87).
23. Shimizu discloses that Seto solution contains NaCl, KCl, MgCl2,
NaH2PO4, Na2HPO4, Na acetate, Na3 citrate, maltose, and glucose (id. at 88,
Table 1).
24. Shimizu discloses that “[s]torage in Seto solution resulted in
improved platelet function after 5 days” (id. at 92, left col.).
25. Shimizu discloses that “[p]latelets suspended in Seto solution
seem to be sensitive to various extrinsic agonists such as leaked ADP and
serotonin and also to contact with other platelets and the interior walls of the
plastic bag” (id. at 92, right col.).
Analysis
We agree with the Examiner that the cited references support a prima
facie case of obviousness. As discussed above in reference to claim 67,
Carmen, Kuratomi, Tsugita, and Wagner would have made it obvious to a
person of ordinary skill in the art to use riboflavin as a photoactive agent in
place of the methylene blue in Carmen’s composition. Shimizu discloses
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that Seto solution was a known platelet storage solution that contained the
components recited in claim 77. This teaching, in combination with
Carmen’s disclosure that any of a variety of additive solutions, including
saline, were suitable for use in its composition, would have provided a
reason for a skilled worker to use Seto solution as the additive solution in
Carmen’s composition.
Appellants argue that “the solution disclosed in the Shimizu reference
also does not contain alloxazine. There is also no teaching or suggestion
that alloxazine could be added to the solution.” (Appeal Br. 18.)
This argument is not persuasive. The Examiner’s rejection is
premised on the obviousness of using Shimizu’s Seto solution as the
additive solution in Carmen’s composition, not on the presence of alloxazine
in Seto solution or the obviousness of adding alloxazine to Seto solution. In
addition, as discussed above with respect to claim 67, Carmen discloses that
any of a variety of additive solutions can be used in combination with a
photoactive compound in its composition. Appellants have pointed to no
evidence to show that a skilled worker would have considered Shimizu’s
Seto solution to be unsuitable for use in Carmen’s composition, or that the
substitution of riboflavin for methylene blue would have affected the choice
of additive solution.
Appellants also argue that Shimizu teaches that Seto solution causes
platelets to be sensitive to extrinsic agonists and “[f]rom this teaching, one
skilled in the art would not think to add riboflavin to Seto solution for fear of
causing the platelets to develop even greater sensitivity” (Appeal Br. 18).
Appellants argue that platelets that are sensitized are removed by the
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patient’s immune system and place the patient at increased risk, and “[o]ne
skilled in the art would not choose a storage solution which would increase
this risk” (id.).
This argument is also unpersuasive. Although Shimizu states that
“[p]latelets suspended in Seto solution seem to be sensitive to various
extrinsic agonists such as leaked ADP and serotonin and also to contact with
other platelets and the interior walls of the plastic bag” (FF 25), it does not
state that this property affected the suitability of platelets stored in Seto
solution for re-infusion into patients. Shimizu states, in fact, that “[s]torage
in Seto solution resulted in improved platelet function after 5 days” (FF 24,
emphasis added), compared to the known AR solution.
Although Appellants argue that platelets that are sensitized place
patients at increased risk (Appeal Br. 18), they have pointed to no evidence
of record supporting that position, and attorney argument is not evidence.
Even assuming that Appellants’ position is correct, however, it is merely one
factor to be considered by those skilled in the art in deciding whether a
platelet storage solution is suitable for use. See Medichem S.A. v. Rolabo
S.L., 437 F.3d 1157, 1165 (Fed. Cir. 2006) (“‘The fact that the motivating
benefit comes at the expense of another benefit, however, should not nullify
its use as a basis to modify the disclosure of one reference with the teachings
of another. Instead, the benefits, both lost and gained, should be weighed
against one another.’”). Here, the improved function of the platelets after
storage in Seto’s solution, and the inactivation of pathogens resulting from
the combination of Shimizu with the composition made obvious by Carmen,
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Kuratomi, Tsugita, Wagner, and Proctor would have provided a skilled
worker with a reason for combining the references cited by the Examiner.
Conclusion of Law
The evidence of record supports the Examiner’s conclusion that
Carmen, Kuratomi, Tsugita, Wagner, Proctor, and Shimizu would have
provided a reason to combine the elements of the composition of claim 77
with a reasonable expectation of success. We therefore affirm the rejection
of claim 77 based on Carmen, Kuratomi, Tsugita, Wagner, Proctor, and
Shimizu, as well as the rejection based on Carmen, Kuratomi, Tsugita,
Wagner, Proctor, Shimizu, Lin ‘742, and Livne. Claims 74, 76, 79, 90, and
92-95 fall with claim 77 because they were not argued separately. 37 C.F.R.
§ 41.37(c)(1)(vii).
IV.
The Examiner has rejected claims 80 and 82 as obvious based on
Carmen, Kuratomi, Tsugita, Wagner, Proctor, and Holme (1987) (Answer
22). The Examiner has rejected claims 83, 85, 86, 88, and 89 as obvious
based on Carmen, Kuratomi, Tsugita, Wagner, Proctor, and Lin (WO)
(Answer 25).
Appellants have waived the opportunity to present additional
arguments directed to these rejections (see Appeal Br. 19-20). We therefore
affirm them for the reasons set out in the Answer and above with respect to
the other rejections on appeal. See Hyatt v. Dudas, 551 F.3d 1307, 1314
(Fed. Cir. 2008) (“When the appellant fails to contest a ground of rejection
to the Board, . . . the Board may treat any argument with respect to that
Appeal 2012-000241
Application 10/377,524

20
ground of rejection as waived. In the event of such a waiver, the PTO may
affirm the rejection of the group of claims that the examiner rejected on that
ground without considering the merits of those rejections.”).
SUMMARY
We affirm all of the rejections on appeal.
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).

AFFIRMED

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