Ex Parte Ericson

Patent Trial and Appeal Board

Nov 10, 2016

13028819 (P.T.A.B. Nov. 10, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/028,819 02/16/2011
26813 7590 11/10/2016
MUETING, RAASCH & GEBHARDT, P.A.
P.O. BOX 581336
MINNEAPOLIS, MN 55458-1336
FIRST NAMED INVENTOR
Daniel G. ERICSON
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.
374.00030101 9503
EXAMINER
KELLER, CHRISTOPHER A
ART UNIT PAPER NUMBER
1657
MAILDATE DELIVERY MODE
11/10/2016 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 PATENT TRIAL AND APPEAL BOARD
Ex parte DANIEL G. ERICSON1
Appeal2015-002998
Application 13/028,819
Technology Center 1600
Before DEMETRA J. MILLS, JEFFREY N. FREDMAN, and
RYAN H. FLAX, Administrative Patent Judges.
FLAX, Administrative Patent Judge.
DECISION ON APPEAL
This is a decision on appeal under 35 U.S.C. § 134(a) involving
claims directed to a blood storage and/or rejuvenating composition. Claims
1-7, 10-17, and 38--40 are on appeal as rejected under 35 U.S.C. §§ 101 and
103(a), and under the doctrine of obviousness-type double patenting. We
have jurisdiction under 35 U.S.C. § 6(b ).
We affirm.
1 We understand the Real Party in Interest to be Viacell, LLC. App. Br. 1.
Appeal2015-002998
Application 13/028,819
STATEMENT OF THE CASE
The appealed claims can be found in the Claims Appendix of the
Appeal Brief. Claims 1, 7, and 1 7 are the independent claims and read as
follows:
1. A blood storage and/or rejuvenating composition comprising
a nucleoside and D-ribose, with the proviso that the nucleoside
is not inosine.
7. A blood storage and/or rejuvenating composition comprising
75 to 1500 mM guanosine and 75 to 1500 mM D-ribose.
17. A blood storage and/or rejuvenating composition
compnsmg:
225 mM guanosine;
300 mM D-ribose;
300 mM sodium pyruvate; and
300 mM inorganic phosphate.
App. Br. 14--15 (Claims App'x).
The following rejections are on appeal:
Claims 1-7, 10-17, and 38--40 stand rejected under 35 U.S.C. § 101
as not directed to patent eligible subject matter. Ans. 7.
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Claims 1-7, 10-13, 17 and 38--40 stand rejected under 35 U.S.C.
§ 103(a) over Prankerd,2 Johnson,3 and Medical Dictionary.4 Rejection 3.5
Claims 14--16 stand rejected under 35 U.S.C. § 103(a) over Prankerd,
Johnson, and Kurauchi. 6 Rejection 6.
Claims 7 and 10-1 7 stand rejected on the ground of nonstatutory
obviousness-type double patenting over claims 1---6 and 10-16 of' 542
Patent,7 Simon,8 and Kurauchi. Rejection 7.
DISCUSSION
The rejection of claims 1-7, 10--17, and 38--40 under 35 U.S.C. § 101.
The Examiner determined that "the claims are drawn to a law of
nature," or, in other words, "[t]he claimed composition is considered a
'Product of Nature' in accordance with" the Supreme Court's opinions in
2 T.A.J. Prankerd M.D., Revival of Stored Blood with Guanosine, 267 THE
LANCET 469--471 (1956) (hereinafter "Prankerd").
3 International Patent Application Pub. No. WO 2004/105483 Al (published
Dec. 9, 2004) (hereinafter "Johnson").
4 Pyruvate, The Free Online Medical Dictionary (http:// medical-
dictionary.thefreedictionary.com/pyruvate, visited June 26, 2012)
(hereinafter "Medical Dictionary") (citing, inter alia, JONAS MOSBY's
DICTIONARY OF COMPLEMENTARY AND ALTERNATIVE MEDICINE (2005)).
5 The appealed office action is the Non-Final Action dated Dec. 4, 2013
(hereinafter "Rejection").
6 U.S. Patent Application Pub. No. US 2004/0192553 Al (published Sept.
30, 2004) (hereinafter "Kurauchi").
7 U.S. Patent No. 8,980,542 B2 (issued Mar. 17, 2015; formerly copending
Application No. 13/028,856) (hereinafter "'543 Patent").
8 E.R. Simon, Adenine and Purine Nucleosides in Human Red Cell
Preservation: A Review, 7 TRANSFUSION 395--400 (1967) (hereinafter
"Simon").
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Myriad and Prometheus. Ans. 8; see Association for Molecular Pathology
v. Myriad Genetics, Inc., 133 S.Ct. 2107 (2013); and Mayo Collaborative
Services v. Prometheus Laboratories, Inc., 132 S.Ct. 1289 (2012). The
Examiner determined that "all the components of the composition are
natural products" and "the use of the compositions [does] not change the
structure of the composition such that it differs from a product of nature. Id.
On issues of patent eligibility, the Supreme Court instructs us to "first
determine whether the claims at issue are directed to a patent-ineligible
concept." Alice Corp. Pty Ltd. v. CLS Bank Int 'l, 134 S. Ct. 2347, 2355
(2014). If this threshold is met, we move to the second step of the inquiry
and "consider the elements of each claim both individually and 'as an
ordered combination' to determine whether the additional elements
'transform the nature of the claim' into a patent-eligible application." Id.
(quoting Prometheus, 132 S. Ct. at 1297-98).
Appellant argues, "[a]lthough both D-ribose and a nucleoside that is
not inosine (e.g., guanosine) might arguably be considered as natural
products, the Examiner has provided no evidence that a composition
comprising both D-ribose and a nucleoside that is not inosine (e.g.,
guano sine) occurs in nature." Reply Br. 3. Taking up the first step of the
Alice-patent-eligibility analysis, we find the claims are directed to a product
of nature. As in Funk Bros. (and similar to Myriad), the claimed invention
combines naturally occurring biological chemicals, here a nucleoside and D-
ribose, and does not change them in any way other than purification. See
Myriad, 133 S. Ct. at 2117 (discussing Funk Bros. Seed Co. v. Kala
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Inoculant Co., 333 U.S. 127, 130-32 (1948)). For this reason, we are
constrained to find the patent-ineligibility exception threshold met.
Turing to the second step under Alice, we review the claims to
ascertain whether the product of nature has been sufficiently transformed, or
in the terminology of Chakrabarty, ultimately possess "markedly different
characteristics from any found in nature," so as to become patent eligible.
See Alice, 134 S. Ct. at 2355; see also Diamond v. Chakrabarty, 447 U.S.
303, 305 (1980). "The [Supreme] Court has recognized[] that too broad an
interpretation of th[ e] exclusionary principle could eviscerate patent law
[because] all inventions at some level embody, use, reflect, rest upon, or
apply laws of nature, natural phenomena, or abstract ideas." Prometheus,
132 S. Ct. at 1293. The claims here are drawn to a composition and that is
the focus of our inquiry.
From the record on appeal, we find neither the Examiner nor
Appellant has discussed or identified how the recited D-Ribose or
nucleosides function in nature, either independently or in combination. We
understand D-Ribose is a carbohydrate and is the naturally-occurring
enantiomeric form of ribose, and is a molecule related to deoxyribose, found
in DNA. Phosphorylated derivatives ofribose, e.g., ATP and NADH, are
involved in metabolism. We understand nucleosides are combinations of a
nitrogenous base and 5-carbon sugar molecules, such as ribose or
deoxyribose, and can be phosphorylated to produce nucleotides and are, in
this way, the molecular foundation of DNA and RNA.
The Examiner determined that the claims do not recite anything
markedly different from the naturally occurring components. Ans. 9. We
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must agree. The claim language, "[a] blood storage and/or rejuvenating
composition," defines how the claimed composition functions, but imposes
no structural limitations on the claimed composition. Upon reviewing the
appealed claims in view of the Specification, Appellant's invention relates to
the recognition that "a pentose carbohydrate (e.g., D-Ribose) [] can serve to
aid de nova synthesis and metabolic salvage of purine nucleotides including
ATP," and that a non-inosine nucleoside can "reduce the breakdown
products produced by inosine, and can further enhance RBC ATP content."
See Spec. 6:29-7:7. Here, the invention is a composition specifically
combining these two components, which has the (apparently natural) ability
to increase blood's 2,3-DPG value9 and, thereby, impart improved blood
storage and/or blood rejuvenation qualities. See Spec. 12: 12-17.
There is no evidence of record that the two recited components
function differently in the claimed composition than they function, either
independently or in combination, in nature. Like the facts of Funk Bros.
(where the inventor combined naturally occurring and non-cross-inhibiting
bacteria for their natural legume inoculation functionality), and unlike the
facts of Chakrabarty (where the inventor created a genetically modified
bacteria capable of breaking down crude oil components), the evidence
supports that the inventor here has done nothing more than bring together
natural components in an unique package. And Myriad expressly teaches
9 2,3-DPG stands for the marker 2,3-diphosphoglycerate, which
characterizes a storage lesion on red blood cells (RBCs) and is found to
decrease after the separation of blood components; this decrease in 2,3-DPG
indicates an increase in the production of oxygen free radicals and a change
in RBC morphology. Spec. 2:23-26.
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that purification "is not an act of invention" and that claims are not
necessarily statutory even if isolation "severs chemical bonds and thereby
creates a nonnaturally occurring molecule." Myriad, 133 S.Ct. at 2117-
2118. The inventor has selected and paired natural biological chemicals, but
has not changed any characteristic thereof from what they would have been
in nature. Thus, the inventor does not claim significantly more than the
product of nature and the claims fail under the second Alice step.
For the reasons above, we find the preponderance of the evidence
supports the Examiner's determination that the claims are patent ineligible
and we affirm the rejection.
The rejection of claims 1-7, 10--13, 17 and 38--40 under 35 U.S. C.
§ 103(a) over Prankerd, Johnson, and Medical Dictionary.
Regarding the obviousness rejections, we adopt the Examiner's
findings of fact, reasoning on scope and content of the prior art, and
conclusions set out in the Final Action and Answer. The Examiner has
established a prima facie case for obviousness and Appellant's arguments
have not persuaded us that this case for obviousness is not correct. Any
findings of fact set forth below are merely to highlight certain evidence. We
address Appellant's arguments below.
Appellant argues the obviousness rejection should be reversed
because the Examiner used the language "as evidenced by" when referring
to the disclosure of the Medical Dictionary because such language is only
appropriate for an anticipation rejection. App. Br. 5. We are not persuaded.
Appellant was well apprised of the substance of and rationale for the
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obviousness rejection, regardless of the language used. See Rejection 3---6.
Moreover, Appellant's contention regarding the timing of the cited prior art
disclosure and argument that obviousness must be predicated on what was
known at the time of invention (App. Br. 5) is also not persuasive because
the cited Medical Dictionary disclosure regarding the definition of pyruvate
refers to a 2005 reference (see fn.4, supra) and the definition was known as
of the date of invention.
Appellant argues Prankerd does not disclose including sodium
pyruvate, inorganic phosphate, or D-ribose in its blood storage/restoring
composition. App. Br. 6. Appellant argues that, even if Prankerd did
disclose D-ribose, its presence in the composition could not be interpreted as
a blood storage and/or rejuvenating composition including D-ribose. Id. 6-
7. Appellant argues that Prankerd' s disclosure of ribose phosphate in its
composition is not a D-ribose molecule. Id. 8. Appellant argues that
Prankerd also does not disclose guanosine in a relevant composition. Id.
Moving on to the Johnson reference, Appellant argues that it fails to
teach or suggest compositions including a nucleoside such as guanosine, and
for this reason, the skilled artisan would not combine it with Prankerd. Id.
8-9. Appellant also argues that while Johnson discloses blood
storage/rejuvenating compositions including D-ribose, phosphoenolpyruvate
(pyruvate ), and sodium phosphate buffer, it fails to disclose all three in one
composition and, so, cannot be relied upon to modify Prankerd. Id. 9.
Finally, Appellant argues Johnson teaches away from using D-ribose in the
invention because it discloses that ribose can be an energy source and
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theoretically regenerates ATP, while Prankerd suggests that adding ATP is
not required because of its own inclusion of a nucleoside. Id. 9-10.
None of Appellant's arguments are persuasive. "The combination of
familiar elements according to known methods is likely to be obvious when
it does no more than yield predictable results." KSR Int 'l Co. v. Teleflex
Inc., 550 U.S. 398, 416 (2007). "[W]hen the question is whether a patent
claiming the combination of elements of prior art is obvious," the answer
depends on "whether the improvement is more than the predictable use of
prior art elements according to their established functions." Id. at 417. "It is
prima facie obvious to combine two compositions each of which is taught by
the prior art to be useful for the same purpose, in order to form a third
composition which is to be used for the very same purpose .... [T]he idea of
combining them flows logically from their having been individually taught
in the prior art." In re Kerkhoven, 626 F.2d 846, 850 (CCPA 1980). When
determining obviousness, "the prior art as a whole must be considered. The
teachings are to be viewed as they would have been viewed by one of
ordinary skill." In re Hedges, 783 F.2d 1038, 1041 (Fed. Cir. 1986).
Here, the combined Prankerd and Johnson references disclose each
element of claims 1, 7, and 17, that is a nucleoside (specifically guano sine)
and D-Ribose, and in the case of claim 1 7, also sodium pyruvate and
inorganic phosphate, and they each teach that these components are used for
the very same purpose as in the appealed claims: "a practical and simple
means of increasing the optimal storage time of blood," per Prankerd; and
"to extend function [of whole blood or packed red cells] in storage," per
Johnson. Prankerd 469 (left col.); Johnson Abstract, 4:26-29, 8: 17-22,
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8:26-30, 11: 11-28. As the Examiner determined, Prankerd also disclosed
using ribose to rejuvenate red blood cells. Ans. 13. It would have been
obvious to combine the disclosures of Prankerd and Johnson for a blood
storage improving composition.
Claims 7 and 17, beyond reciting the components for the blood
storage composition, further recite quantities or concentrations thereof.
However, this is not a patentable distinction.
"[I]t is not inventive to discover the optimum or workable ranges by
routine experimentation." In re Aller, 220 F.2d 454, 456 (CCPA 1955); see
also In re Peterson, 315 F.3d 1325 (Fed. Cir. 2003). "Only if the 'results of
optimizing a variable' are 'unexpectedly good' can a patent be obtained for
the claimed critical range." In re Geisler, 116 F.3d 1465, 1469 (Fed. Cir.
1997) (quoting In re Antonie, 559 F.2d 618, 620 (CCPA 1977)).
"[D]iscovery of an optimum value of a result effective variable in a known
process is ordinarily within the skill of the art." In re Boesch, 617 F.2d 272,
276 (CCPA 1980). Appellant's arguments fail under these tests. Appellant
has not presented persuasive evidence that the quantity/concentration
elements of the claims were unexpectedly good or critical and we are not
persuaded that they amount to more than routine optimization.
Finally, Johnson does not teach away from the invention or its
combination with Prankerd.
A reference may be said to teach away when a person of ordinary
skill, upon reading the reference, would be discouraged from
following the path set out in the reference, or would be led in a
direction divergent from the path that was taken by the applicant.
The degree of teaching away will of course depend on the
particular facts; in general, a reference will teach away if it
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suggests that the line of development flowing from the
reference's disclosure is unlikely to be productive of the result
sought by the applicant.
In re Gurley, 27 F.3d 551, 553 (Fed. Cir. 1994). Here, both Prankerd and
Johnson provide the various components recited by the claims to the same
end, that is, to support stored blood. Johnson suggests D-ribose is added as
a substitute for dextrose, the energy source for blood stored in CPD or
CDPA, and may be an energy source for glycolysis and for regeneration of
ATP. Johnson 7: 18-19. According to Prankerd, ATP is not needed with the
ribose of the nucleoside; however, Prankerd does not indicate that an energy
source or ATP generation is not needed at all in blood storage or blood
rejuvenation. Thus, there is no direct teaching away from the combination
of these references.
For the above reasons, we find that the preponderance of evidence of
record supports the Examiner's determination that the claims would have
been obvious. We affirm the rejection.
The rejection of claims 14-16 under 35 U.S. C. § 103 (a) over
Prankerd, Johnson, and Kurauchi.
Appellant presents no arguments concerning this rejection different
from those presented for the prior rejection, other than Kurauchi "fails to
provide that which is missing from Prankerd in view of Johnson." App. Br.
11. For the same reasons set forth above concerning the prior obviousness
rejection, we affirm this rejection as well.
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The rejection of claims 7 and 10--17 on the ground of nonstatutory
obviousness-type double patenting.
Because Appellant presents no arguments pertaining to the
Examiner's double patenting rejection (App. Br. 12), we summarily sustain
the rejection. See MPEP § 1205.02, 9th ed., Rev. 7, Nov. 2015.
SUMMARY
The rejection of claims 1-7, 10-17, and 38--40 under 35 U.S.C. § 101
is affirmed.
The rejection of claims 1-7, 10-13, 17, and 38--40 under 35 U.S.C.
§ 103(a) over Prankerd, Johnson, and Medical Dictionary is affirmed.
The rejection of claims 14--16 under 35 U.S.C. § 103(a) over
Prankerd, Johnson, and Kurauchi is affirmed.
The rejection of claims 7 and 10-17 on the ground of nonstatutory
obviousness-type double patenting over claims 1---6 and 10-16 of '542
Patent, Simon, and Kurauchi is affirmed.
The claims were argued as a group, therefore all claims fall with claim
1. 37 C.F.R. § 41.37(c)(l)(iv).
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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