Ex Parte Shaz et al

Patent Trial and Appeal Board

Nov 23, 2018

13483379 (P.T.A.B. Nov. 23, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
13/483,379 05/30/2012 Beth Shaz
45200 7590 11/27/2018
K&L Gates LLP-Orange County
1 Park Plaza
Twelfth Floor
IRVINE, CA 92614
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.
1958427-00196 5461
EXAMINER
MCNEIL, STEPHANIE AN
ART UNIT PAPER NUMBER
1653
NOTIFICATION DATE DELIVERY MODE
11/27/2018 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):
uspatentmail@klgates.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte BETH SHAZ and CHRISTOPHER D. HILL YER
Appeal 2017-011723
Application 13/483,379 1
Technology Center 1600
Before DONALD E. ADAMS, RICHARD M. LEBOVITZ, and
MICHAEL J. FITZPATRICK, Administrative Patent Judges.
ADAMS, Administrative Patent Judge.
DECISION ON APPEAL
This Appeal under 35 U.S.C. § 134(a) involves claims 1-21 (App. Br.
5). 2 Examiner entered rejections under 35 U.S.C. § 103(a). We have
jurisdiction under 35 U.S.C. § 6(b ).
We REVERSE.
1 Appellants identify "New York Blood Center, Inc." as the real party in
interest (App. Br. 3).
2 Appellants' Appeal Brief filed March 27, 2017.
Appeal2017-011723
Application 13/483,379
STATEMENT OF THE CASE
Appellants' disclosure relates to "methods of producing uniform dose
and volume pathogen-free blood components." (Spec. ,r 5). Appellants'
claim 1 is representative and reproduced below:
1. A method for preparing uniform dose blood component
transfusion products, the method comprising the following
steps in the recited order:
a) leukoreducing 5-100 individual whole blood units
from different donors of the same blood group and type to form
leukoreduced blood components, wherein the leukoreduced
blood components comprise red blood cells (RBCs ), platelets,
and plasma;
b) pooling the leukoreduced blood components from the
5-100 individual blood units to form a pooled leukoreduced
blood component;
c) treating the pooled leukoreduced blood component to
inactivate one or more pathogens;
d) separating a pooled RBC component, a pooled platelet
component, and a pooled plasma component from the pooled
leukoreduced blood component;
e) adding a storage solution to the pooled RBC
component and dividing the pooled RBC component into
uniform volume and dose RBC transfusion product units,
wherein each uniform volume and dose RBC transfusion
product unit contains a uniform number of RBCs or a uniform
amount of hemoglobin;
f) adding a storage solution to the pooled platelet
component and dividing the pooled platelet component into
uniform volume and dose platelet transfusion products units,
wherein each uniform volume and dose platelet transfusion
product unit contains a uniform number of platelets; and
g) dividing the pooled plasma component into uniform
volume and dose plasma transfusion product units.
(App. Br. 25.)
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Application 13/483,379
Grounds of rejection before this Panel for review:
Claims 1-5, 9-14, and 18-21 stand rejected under 35 U.S.C. § I03(a)
as unpatentable over the combination of Fujihara, 3 Hei, 4 Hess, 5 and
Cardoso. 6
Claims 6, 8, 15, and 17 stand rejected under 35 U.S.C. § I03(a) as
unpatentable over the combination of Fujihara, Hei, Hess, Cardoso, and
Zhang. 7
Claims 7 and 16 stand rejected under 35 U.S.C. § I03(a) as
unpatentable over the combination of Fujihara, Hei, Hess, Cardoso, and
Beutler. 8
Claim Interpretation:
Due to an Election of Species Requirement, Examiner limited the
scope of: The "storage solution" set forth in Appellants' claims 2 and 11 to
a storage solution that comprise at least phosphate and the method of
inactivating one or more pathogen to at least irradiation (see Final Act. 9 2;
3 Fujihara et al., Prestorage leucofiltration prevents the accumulation of
matrix metalloproteinase-9 in red cell concentrates stored in mannitol-
adenine-phosphate medium, 89 VoxSanguinis 114-15 (2005).
4 Hei et al., US 2002/0192632 Al, published Dec. 19, 2002.
5 Hess et al., US 6,447,987 Bl, issued Sept. 10, 2002.
6 Cardoso et al., Mini-pool screening by nucleic acid testing for hepatitis B
virus, hepatitis C virus, and HIV.preliminary results, 38 TRANSFUSION 905-
907 (1998).
7 Zhang et al., Cell Counter, Blood in ENCYCLOPEDIA OF MEDICAL DEVICES
AND INSTRUMENTATION, 81-90 (2nd ed., John G. Webster ed., John Wiley &
Sons 2006).
8 Beutler et al., The definition of anemia: what is the lower limit of normal
of the blood hemoglobin concentration?, 107 BLOOD 147-50 (2005).
9 Examiner's Final Office Action mailed November 3, 2016.
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Application 13/483,379
see also Examiner's February 22, 2013 Office Action; Appellants' Response
to Restriction Requirement filed March 20, 2013; and Examiner's Non-Final
Office Action mailed April 22, 2013). We limit the scope of our review to
Appellants' elected invention. Ex parte Ohsaka, 2 USPQ2d 1460, 1461
(BP AI 1987).
We are not persuaded by Examiner's interpretation of "the phrase
'transfusion products' ... to include any sample which is capable of being
administered to a subject regardless of the outcome of said administration"
(Final Act. 2 (emphasis added); see also Ans. 10 2; cf App. Br. 22-23; Reply
Br. 11 2-3). To the contrary, we agree with Appellants' reasoning that "[t]o
conclude that a term for a medicinal product being made for intravenous or
intra-arterial administration encompasses anything that is capable of
administration regardless of the outcome of said administration ... is
contrary to plain and accepted meaning and inconsistent with [Appellants']
[S]pecification" (Reply Br. 2; see also App. Br. 22 ("to one of ordinary skill
in the art, a transfusion product comprises blood or a blood component that
by its collection and processing can be expected to be safe and effective
when used for transfusion")).
In addition, the evidence of record establishes that Examiner's
interpretation of the term "transfusion products" is inconsistent with how
those of ordinary skill in this art interpret the term (see e.g., Hess 2:8-11
("packed RBCs stored in the medium were not directly infusible but required
the removal of the supernatant with a washing step prior to transfusion due
to the presence of ammonium in the additive solution"); id. at 11. 17-19 ("the
10 Examiner's Answer mailed July 19, 2017.
11 Appellants' Reply Brief filed September 18, 2017.
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resulting RBC units contained about 1 percent glycerol and thus, are not safe
for transfusion in humans in massive amounts"); id. at 11. 24--26 ("such
stored RBC suspensions were not acceptable for direct infusion due to their
high content of potassium and ammonia and their low volume fraction of
RBCs")).
Obviousness:
ISSUE
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness?
FACTUAL FINDINGS (FF)
FF 1. Fujihara discloses collecting whole blood from donors, dividing each
donor's collected blood into two aliquots of equal volume, and filtering one
aliquot from each donor (Fujihara 114; see Final Act. 4).
FF 2. Fujihara discloses preparing red cell concentrates (RCC) in
mannitol-adenine-phosphate (MAP) medium from leukoreduced whole
blood (Fujihara 114; see Final Act. 3 (Fujihara discloses "leukoreducing []
blood through a filter, before separating red blood cell concentrates from the
whole leukoreduced blood")).
FF 3. Examiner finds that "removing the red blood cells from [] whole
leukoreduced blood would result in a plasma/platelet fraction that is not
whole blood" (Final Act. 3).
FF 4. Fujihara discloses gamma irradiating RCC in MAP medium
prepared from non-leukoreduced whole blood collected from donors
(Fujihara 114; see Final Act. 4).
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FF 5. Examiner finds that Fujihara does not disclose pooling samples from
5-100 individual whole blood units from different donors of the same blood
group and type to form leukoreduced blood components, "separating and
storing the platelet and plasma fractions" or that "irradiation ... and
solvent/detergent treatment ... can be used to inactivate pathogens" (Final
Act. 3).
FF 6. Hei "relates to methods and devices for the removal of substances
from blood products and particularly to methods and devices for the removal
of psoralens and psoralen photoproducts from plasma that contains platelets
without significantly affecting platelet function" (Hei ,r 1 ).
FF 7. Examiner finds that Hei discloses counting "the number of red blood
cells [ and platelets] in a sample," "separating [] platelets and plasma from
whole blood and transferring selected volumes of the samples into bags" and
concentrating platelets (Final Act. 3--4).
FF 8. Hess "relates to methods and materials associated with the storage of
whole blood and red blood cells (RBC)" (Hess 1 :23-25).
FF 9. Hess "provide[s] an additive solution for storage of human RBC's
which is physiologically safe and suitable for direct infusion into humans in
massive amounts" (Hess 2:49-52).
FF 10. Hess discloses studies "to evaluate RBC metabolism and physiology
over an 11 week period," wherein "RBC units were grouped into sets of 4
ABO-matched units, each set was then pooled, mixed and realiquoted into
identical pooled units" (Hess 6:44--50; see id. at 11. 46--48 ("Pooling reduces
the largest source of variability in conventional blood storage studies, e.g.
different donors"); see also id. 9:40-61 ( describing the collection and
pooling of blood from donors for experimental study); Final Act. 4).
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FF 11. Cardoso discloses the collection of an "extra barcoded serum
sample" from blood donors for nucleic acid testing (NAT)-based viral
screening, wherein "[ s ]amples are pooled to a maximum of 96" and
"[p ]ositive results are resolved through intersecting subpools ( a chessboard
design)" (Cardoso 905; see Final Act. 4).
FF 12. Examiner relies on Zhang to disclose that "the concentration of
RBCs in whole blood is between 4 - 6 * 106 cells per µL" (Final Act. 9).
FF 13. Examiner relies on Beutler to disclose that "the concentration of
hemoglobin in whole blood is about 12.88-15.43 g * dL- 1" (Final Act. 10).
ANALYSIS
The rejection over the combination of Fujihara, Hei, Hess, and Cardoso:
Based on the combination of Fujihara, Hei, Hess, and Cardoso,
Examiner concludes that, at the time Appellants' invention was made, it
would have been prima facie obvious to modify Fujihara by, inter alia,
"pooling blood samples from multiple donors as taught by Hess and
Cardoso" (Final Act. 4--5). We are not persuaded that such a modification
would have resulted in the claimed subject matter.
To the contrary, we agree with Appellants' contention that none of
Fujihara, Hei, Hess, and Cardoso "suggests processing pooled blood or
blood components to produce blood component transfusion product units" as
required by Appellants' claimed invention (App. Br. 18). In this regard, we
agree with Appellants' contention that the discussions of pooling blood
samples in the references relate to the preparation of experimental samples
not transfusion products (see e.g., id. at 19 ("words like 'pooling' or pooled'
are plucked out of the references [by Examiner without regard to the]
context of what is being pooled ... and why it is being pooled ( clinical
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testing in Cardoso; experimental testing in Hess"); see also id. at 20 ("in the
cited references pooling is not associated with the production of transfusion
product units at all. Rather pooling is conducted to create reagents for
experimentation (as in Hess) or testing (as in Cardoso)")).
Appellants' claims call for the production of transfusion products.
Thus, the product produced by Appellants' claimed methods must be useful
for transfusion. For the reasons discussed above, we are not persuaded by
Examiner's assertion that those of ordinary skill in this art would consider a
"transfusion product" to represent "any sample which is capable of being
administered to a subject regardless of the outcome of said administration"
(Final Act. 2 ( emphasis added); see also Ans. 12 2). To the contrary, the
evidence of record, as discussed above, establishes that transfusion products
must be safe and acceptable for transfusion/infusion. Therefore, we are not
persuaded by Examiner's assertion that Appellants' claimed invention does
not limit the scope of the term "transfusion products" to those that are useful
for transfusion because Appellants' claims do not recite a step of transfusing
or administering the transfusion products (Ans. 8 and 10).
In sum, Examiner failed to establish an evidentiary basis on this
record to support a conclusion that the combination of Fujihara, Hei, Hess,
and Cardoso make obvious Appellants' claimed invention.
The rejection over the combination of Fujihara, Hei, Hess, Cardoso, and
either of Zhang or Beutler:
Based on the combination of Fujihara, Hei, Hess, Cardoso, and either
of Zhang or Beutler, Examiner concludes that, at the time Appellants'
12 Examiner's Answer mailed July 19, 2017.
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invention was made, it would have been prima facie obvious to
"incorporat[ e] the teachings of Zhang in Fujihara' s method because Zhang is
cited solely as evidence of the number of RBCs and platelets inherently
present in a given volume of whole blood" (Ans. 9) or "incorporat[e] the
teachings of Beutler in Fujihara's method because Beutler is cited solely as
evidence of the concentration of hemoglobin inherently present in a given
volume of whole blood" (id. at 10). We are not persuaded that such a
combination would have resulted in the claimed subject matter.
Examiner failed to establish that either of Zhang or Beutler make up
for the deficiencies in the combination of Fujihara, Hei, Hess, and Cardoso
discussed above (see App. Br. 24 ("Zhang [ or Beutler] offer[] nothing to
repair the deficiencies discussed above of Fujihara, Hei, Hess, and
Cardoso").
CONCLUSION
The preponderance of evidence relied upon by Examiner fails to
support a conclusion of obviousness.
The rejection of claims 1-5, 9-14, and 18-21 under 35 U.S.C.
§ 103(a) as unpatentable over the combination of Fujihara, Hei, Hess, and
Cardoso is reversed.
The rejection of claims 6, 8, 15, and 17 under 35 U.S.C. § 103(a) as
unpatentable over the combination of Fujihara, Hei, Hess, Cardoso, and
Zhang is reversed.
The rejection of claims 7 and 16 under 35 U.S.C. § 103(a) as
unpatentable over the combination of Fujihara, Hei, Hess, Cardoso, and
Beutler is reversed.
REVERSED
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