Ex Parte Rader et al

Board of Patent Appeals and Interferences

Aug 24, 2010

10282766 (B.P.A.I. Aug. 24, 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.
10/282,766 10/28/2002 William C. Rader 94150.912 6565
22804 7590 08/24/2010
THE HECKER LAW GROUP
1925 CENTURY PARK EAST
SUITE 2300
LOS ANGELES, CA 90067
EXAMINER
TON, THAIAN N
ART UNIT PAPER NUMBER
1632
MAIL DATE DELIVERY MODE
08/24/2010 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 WILLIAM C. RADER and ALBERT SCHELLER
__________

Appeal 2009-013818
Application 10/282,766
Technology Center 1600
__________

Before CAROL A. SPIEGEL, LORA M. GREEN, and
MELANIE L. McCOLLUM, Administrative Patent Judges.

GREEN, Administrative Patent Judge.

DECISION ON APPEAL1
This is a decision on appeal2 under 35 U.S.C. § 134 from the
Examiner’s rejection of claims 1 and 5-8.

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.
2 Oral hearing held August 11, 2010.
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We have jurisdiction under 35 U.S.C. § 6(b).

STATEMENT OF THE CASE
Claim 1 is representative of the claims on appeal, and reads as
follows:
1. A method for aiding in the diagnosis of a human patient comprising
the steps of:
labeling hematopoetic [sic] and neuronal stem cells isolated from a
human fetus with a biocompatible label;
administering the labeled stem cells to the patient via injection; and
identifying one or more regions within the patient where the labeled
stem cells have accumulated.

The following objections and grounds of rejection are before us for
review:
I. The amendments to the Specification filed January 15, 2008, and
October 15, 2008, stand objected to as introducing new matter into
the disclosure.
II. Claims 1 and 5-8 stand rejected under 35 U.S.C. § 112, first
paragraph, as containing new matter.
III. Claims 1 and 5-8 stand rejected under 35 U.S.C. § 112, first
paragraph, for lack of enablement.
IV. Claims 1 and 5-8 stand rejected under 35 U.S.C. § 112, second
paragraph, as being indefinite.
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We decline to reach the objections of issue I, 3 reverse rejections II
and IV, and affirm rejection III.

ISSUE II
Has the Examiner established by a preponderance of the evidence that
claim 1 as appealed contains new matter?

FINDINGS OF FACT
FF1 The Examiner’s statement of the new matter rejection may be found at
pages 18-20 of the Examiner’s Answer.
FF2 Claims 72-74 of parent application 09/907,790, now abandoned, of
which this case is a divisional, read as follows:
72. A method for locating a region of traumatic, hypoxic or
other disease state in a patient, the method comprising the steps
of: labeling human embryonic stem cells with a biocompatible

3 MPEP § 2163.06 states:
A rejection of claims is reviewable by the Board of Patent
Appeals and Interferences, whereas an objection and
requirement to delete new matter is subject to supervisory
review by petition under 37 CFR 1.181. If both the claims and
specification contain new matter either directly or indirectly,
and there has been both a rejection and objection by the
examiner, the issue becomes appealable and should not be
decided by petition.
As we are reversing the new matter rejection of the claims, and as the issues
involved in determining whether the Amendments to the Specification
introduce new matter into the original disclosure are different from those in
determining whether new matter has been added to the claim, we decline to
exercise our discretion to review the Amendment to the Specification that
have been objected to by the Examiner as containing new matter.
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label; administering the labeled embryonic stem cells to the
patient via intravenous injection; and detecting the labeled
embryonic stem cells to thereby identify the region of
traumatic, hypoxic or other disease state in the patient where
the labeled embryonic stem cells have accumulated.
73. The method of claim 72, wherein the embryonic stem
cells are prepared according to the method of claim 1.
74. The method of claim 72, wherein the hematopoietic stem
cells and the neuronal stem cells are extracted from a human
embryo.

(See, e.g., App. Br. 13.)

ANALYSIS
Appellants argue that claim 1 as presented for appeal is supported by
original claims 72-74 as set forth in the parent application. (App. Br.4 13-
14.)
We find that original claims 72 and 74 provide literal support for
claim 1 as it now reads, and thus that claim 1 as appealed does not constitute
new matter per se. We are therefore compelled to reverse the new matter
rejection. In re Gardner, 480 F.2d 879 (CCPA 1973).

CONCLUSION OF LAW
We thus conclude that the Examiner has not established by a
preponderance of the evidence that claim 1 as appealed contains new matter,
and thus reverse the rejection of claims 1 and 5-8 under 35 U.S.C. § 112,
first paragraph, as containing new matter.

4 All references to the Appeal Brief (App. Br.) are to the Supplemental
Appeal Brief dated March 25, 2009.
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ISSUE III
Has the Examiner established by a preponderance of the evidence that
the Specification fails to enable the method of claim 1?

CLAIM INTERPRETATION
Appealed claim 1 is drawn to a method “for aiding in the diagnosis of
a human patient” comprising “labeling hematopoetic [sic] and neuronal stem
cells.” Before we reach the merits of the enablement rejection, we need
interpret the claims terms “hematopoetic [sic] and neuronal stem cells.” To
interpret those terms, we look at both the Specification and how the terms
are used in the art.
Initially, we note that this is the second time this application has been
before us on appeal—the first time as Appeal No. 2007-3218, decided
December 6, 2007 (2007 Decision). The issue in that Appeal was how the
ordinary artisan would interpret “embryonic stem cell” in light of the
Specification and how the term was understood in the art. (2007 Decision,
p. 3.) While the Decision noted that the Specification may blur the
distinction between embryonic stem cells, hematopoietic, and neuronal stem
cells (id. at 8.), the Decision concluded that the preponderance of the
evidence supported the interpretation of “embryonic stem cells” as being
“stem cells that are pluripotent, having the development potential to give rise
to any differentiated cell type” (id. at 13.). The Decision also concluded that
the term “embryonic stem cells” did not encompass hematopoietic stem cells
and neuronal stem cells, as those stem cell types are not pluripotent. (Id. at
14.)
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We acknowledge that during prosecution before the Office, claims are
to be given their broadest reasonable interpretation consistent with the
Specification as it would be interpreted by one of ordinary skill in the art. In
re American Academy of Science Tech Center, 367 F.3d 1359, 1364 (Fed.
Cir. 2004). But, it is “the general rule that words in patent claims are given
their ordinary meaning in the usage of the field of the invention, unless the
text of the patent makes clear that a word was used with a special meaning.”
Toro Co. v. White Consol. Indus., 199 F.3d 1295, 1299 (Fed. Cir. 1999).
Appellants rely on original claims 72-74 for support that the term
“embryonic stem cells” encompasses hematopoietic and neuronal stem cells.
(See App. Br. 13-14.) That is, according to Appellants, original claim 72 as
filed in the parent application is identical to claim 15 as originally presented
in the instant application as filed, and that claim 74 “limited the stem cells
used to hematopoeitic and neuronal stem cells extracted from a human
fetus.” (Id. at 14.) Appellants also rely on the Declaration of Dennis M.
Nigro, filed October 15, 2008 (Nigro Declaration) (App. Br. 15-17), which

5 Claim 1 as filed in the instant Application reads as follows:
1. A method for locating a region of traumatic, hypoxic or
other disease state in a patient, the method comprising the steps
of:
labeling human embryonic stem cells with a
biocompatible label;
administering the labeled embryonic stem cells to the
patient via intravenous injection; and
detecting the labeled embryonic stem cells to thereby
identify the region of traumatic, hypoxic or other disease state
in the patient where the labeled embryonic stem cells have
accumulated.
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states that at the time of filing, “there was no universal terminology used to
describe different types and stages of human stem cells, and that
terminology was in a state of flux.” (Nigro Declaration, ¶4.) The Nigro
Declaration avers that as used in original claim 73, “the term ‘embryonic
stem cells’ refers to stem cells isolated from an early stage embryo” (id. at
¶9 (b)), and that “when the term ‘embryonic stem cells’ is used in
connection with the terms ‘neuronal’ or ‘hematopoietic’ in the patent
application, then it refers to stem cells isolated from a human fetus” (id. at
¶8).
As noted in the 2007 Decision, the interpretation of “embryonic stem
cells” as being limited to as “stem cells that are pluripotent, having the
developmental potential to give rise to any differentiated cell type” was
consistent with the one unambiguous definition provided by the
Specification. (2007 Decision, 13-14.) That interpretation is also consistent
with the understanding of that term as used by the ordinary artisan at the
time of filing of the instant application, as evidence by Thompson6 and
Shamblott7 references (id. at 14), which references are cited by the instant
Specification (id. at 11 (citing Spec. at 2 and 4)).
The 2007 Decision further references the teaching of the Specification
as filed that “[t]he pluripotent stem cells [i.e., the embryonic stem cells] can
further specialize into stem cells committed to develop into particular cell

6 Thomson et al., Embryonic Stem Cell Lines Derived from Human
Blastocysts, 282 SCIENCE 1145-1147 (1998).
7 Shamblott et al., Derivation of pluripotent stem cells from cultured human
primordial germ cells, 95 PROC. NAT’L ACAD. SCI. USA, 13726-13731
(1998).
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types. For example, hematopoietic stem cells will give rise to red blood
cells, white blood cells, and platelets, while neuronal stem cells will give rise
to the various types of nerve cells.” (2007 Decision, 14.) Based on that
teaching of the Specification, and the interpretation of “embryonic stem
cells” as set forth above, the 2007 Decision further interpreted the term
“embryonic stem cells” as excluding “hematopoietic stem cells and neuronal
stem cells, as those stem cell types are not pluripotent.” (Id. at 14.)
Given the findings and conclusions in the 2007 Decision, we do not
find that claims 72-74 as filed in the parent application, nor the Nigro
Declaration, are sufficient to convince us that the 2007 Decision was in
error—i.e., that “embryonic stem cells” should be interpreted as
encompassing “hematopoietic stem cells and neuronal stem cells.” As noted
above, claim terms are to be interpreted as would be understood by the
ordinary artisan unless the text of the disclosure as originally filed makes
clear that a word was used with a special meaning. The interpretation of the
terms “embryonic stem cells” and “hematopoietic stem cells and neuronal
stem cells” as set forth in the 2007 Decision is consistent with how the terms
were used in the art, and original claims 72-74 as filed in the parent
application do not set forth an unambiguous definition to the contrary. As
for the Nigro Declaration, the Declaration does not point to any teaching in
the Specification that sets forth an unambiguous definition to the contrary.
We thus interpret the terms “embryonic stem cells” and
“hematopoietic stem cells and neuronal stem cells” as set forth in the 2007
Decision. That is:
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“embryonic stem cells” are interpreted as being “stem cells that are
pluripotent, having the development potential to give rise to any
differentiated cell type;”
“hematopoietic stem cells” are interpreted as being stem cells that
give rise to red blood cells, white blood cells, and platelets; and
“neuronal stem cells” are interpreted as being stem cells that give rise
to the various types of nerve cells.
In addition, we interpret the term “embryonic stem cells” as excluding
the terms “hematopoietic stem cells and neuronal stem cells,” as
hematopoietic stem cells and neuronal stem cells are not pluripotent.

FINDINGS OF FACT
FF3 As to the method of claim 1, the Specification teaches:
It has been found that embryonic stem cells, when placed
in an environment where they can migrate among other cells,
preferentially accumulate near stressed cells, such as cells with
damaged membranes, or cancer cells. This characteristic
suggests that embryonic stem cells, injected intravenously or
subcutaneously, may target sites of cell damage, allowing the
injected embryonic stem cells to accumulate at and repair
damaged tissue.
It is not completely clear how embryonic stem cells
detect and distinguish between stressed and unstressed cells, or
between cancer and noncancer cells, but the reduced membrane
potential of the cancer cells and cells with damaged membranes
from other traumatic, hypoxic or diseased states may play a
role. It is known, for example, that cancer cells have a lower
membrane potential, typically from about -40 mV to about 0
mV, than noncancer cells. Embryonic stem cells, administered
to a patient having a tumor or other site of cell damage, detect
the lower membrane potential of the cancer and/or damaged
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cells, preferentially migrating and accumulating at the site of
the tumor or other cell damage.
Whatever the exact mechanism, this characteristic of
embryonic stem cells also makes them useful as a diagnostic
reagent. For example, embryonic stem cells may be labeled
with a biocompatible agent such as technetium, indium, iodium
and the like, then administered to a patient displaying
symptoms of an unknown etiology or to detect an asymptomatic
underlying or latent disease process. After allowing sufficient
time for the administered cells to circulate through the body, the
patient may be examined to detect the specific label used on the
cells and to thereby determine sites of accumulated labeled
cells. Such sites should be considered potential areas of tissue
damage, tumor growth, or undiscovered potential disease
processes.

(Spec. 14-15.)
FF4 The Specification then describes an in vitro experiment conducted in a
Petri dish, wherein “[e]mbryonic stem cells labeled with ethidium bromide
were found to migrate preferentially to human cells that had been stressed,
causing damage to the cell membrane, or to human cancer cells, or, most
preferentially, to stressed human cancer cells.” (Id. at 18-19, Example 2.)
FF5 The methods were performed using stressed and unstressed H9 cells, a
CD4+ lymphoblast cell line, and stressed or unstressed K562 cells, an
erythroleukemia cell line. (Id. at 19.) The cells were stressed by subjecting
them to three cycles of a rapid freeze/thaw. (Id.)
FF6 The Examiner’s statement of the enablement rejection is set forth at
pages 9-18 of the Examiner’s Answer. As Appellants have not argued the
claims separately, we focus our analysis on claim 1, and claims 5-8 stand or
fall with that claim. 37 C.F.R. § 41.37(c)(1)(vii).
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FF7 Specifically, the Examiner finds that the Specification teaches that
when undifferentiated embryonic stem [ES] cells are placed in an
environment where they can migrate among other cells, they preferentially
accumulate near stressed cells, such as cancer cells and cells with damaged
membranes. (Ans. 10.) The Examiner notes that the only such experiments
performed were performed in vitro in a petri dish. (Id. at 10-11.)
FF8 According to the Examiner, the in vitro example “does not provide a
nexus to the in vivo consequences of administration of ES cells to an
individual.” (Id. at 15.) The Examiner notes further that the “human body is
far more complex than a petri dish, such that many cells, not only stressed
cells would be present.” (Id. at 16.)
FF9 The Examiner notes further that the Specification
provides no teaching with regard to utilizing HSCs
[hematopoietic stem cells] or NSCs [neuronal stem cells],
isolated from a human fetus in aiding in the diagnosis of a
human patient. The specification provides only guidance with
regard to ES cells, and no guidance with regard to utilizing
HSCs or NSCs in the claimed method.

(Id. at 11.)

PRINCIPLES OF LAW
“[E]nablement requires that the specification teach those in the art to
make and use the invention without ‘undue experimentation.’ That some
experimentation may be required is not fatal; the issue is whether the amount
of experimentation required is not ‘undue.’” In re Vaeck, 947 F.2d 488, 495,
(Fed. Cir. 1991) (citation omitted, emphasis in original). “Whether undue
experimentation is needed is not a single, simple factual determination, but
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rather is a conclusion reached by weighing many factual considerations.” In
re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988).
“Patent protection is granted in return for an enabling disclosure of an
invention, not for vague intimations of general ideas that may or may not be
workable. See Brenner v. Manson, 383 U.S. 519, 536 (1966) (stating, in
context of the utility requirement, that ‘a patent is not a hunting license. It is
not a reward for the search, but compensation for its successful
conclusion.’). Tossing out the mere germ of an idea does not constitute
enabling disclosure. While every aspect of a generic claim certainly need
not have been carried out by an inventor, or exemplified in the specification,
reasonable detail must be provided in order to enable members of the public
to understand and carry out the invention.” Genentech Inc. v. Novo Nordisk
A/S, 108 F.3d 1361, 1366 (Fed. Cir. 1997). “If mere plausibility were the
test for enablement under section 112, applicants could obtain patent rights
to ‘inventions’ consisting of little more than respectable guesses as to the
likelihood of their success. When one of the guesses later proved true, the
‘inventor’ would be rewarded the spoils instead of the party who
demonstrated that the method actually worked. That scenario is not
consistent with the stautory requirement that the inventor enable an
invention rather than merely proposing an unproved hypothesis.”
Rasmusson v. SmithKline Beecham Corp., 413 F.3d 1318, 1325 (Fed. Cir.
2005).

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ANALYSIS
Appellants argue8 that the basis of the Examiner’s enablement
rejection is “essentially” the same as the new matter rejection, that is “there
was no explicit disclosure (and hence no enabling disclosure) of the claimed
method for ‘aiding in the diagnosis of a human patient’ using ‘hematopoietic
and neuronal stem cells isolated from a human fetus’ as claimed.” (Reply
Br. 6 (emphasis in original).) Appellants assert that the claimed invention is
disclosed in the original Specification and claims. (Id. at 15.) Specifically,
Appellants argue:
[T]he invention claimed in claim 1 was in fact disclosed in the
original specification and claims. Such disclosure is clearly
enabling to a lay person, let alone of ordinary skill in the art.
As disclosed, to practice the claimed method, hematopoietic
and neuronal stem cells extracted from a human fetus are
labeled with a biocompatible label (such as, for example,
iodium, as is well known in the art), injected into a patient, and
then the patient is examined to determine any areas where the
injected cells have accumulated (using for example
conventional detecting equipment for biocompatible labels that
are well-known in the art). As disclosed in the specification,
any such identified locations are potential areas for trauma or
disease. The method thus aids in the diagnosis of a human
patient by identifying starting points for further examination.

(Id.)
Appellants’ arguments are not convincing. We do not see the issue as
whether the disclosure as filed explicitly disclosed the method of claim of
claim 1, but whether the disclosure as filed would enable the skilled artisan

8 Note that arguments not made are waived. See 37 C.F.R.
§ 41.37(c)(1)(vii).
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to practice the method of claim 1. See e.g., In re Cavallito, 306 F.2d 505,
510 (CCPA 1962) (finding that the language of the original claim was
“broader than the written description of the invention in the specification.”)
As noted by the Examiner, the Specification discloses the use of embryonic
stem cells in a method of detecting cells from two different cell lines
performed in a petri dish, where the cells were stressed by subjecting them
to rapid freeze/thaw cycles.
First, according to the claim interpretation set forth above, the term
“embryonic stem cells” has been interpreted as excluding the terms
“hematopoietic stem cells and neuronal stem cells,” as hematopoietic stem
cells and neuronal stem cells are not pluripotent. Appellants have provided
no evidence or argument that the skilled artisan would have reasonably
expected hematopoietic stem cells, which give rise to red blood cells, white
blood cells, and platelets, and neuronal stem cells, which rise to the various
types of nerve cells, to behave in the same manner as undifferentiated
embryonic stem cells.
Second, even if we were to assume for the sake of argument that when
the Specification teaches the use of embryonic stem cells in the method of
Example 2, encompassed within that term is “hematopoietic stem cells and
neuronal stem cells,” the Specification would still not enable the use of any
of those cells in the method of claim 1. Example 2 was performed in a petri
dish using cell lines and artificially stressed cells. As again noted by the
Examiner, the human body is far more complex than a petri dish. Thus, the
in vitro example does not provide a nexus to the in vivo consequences of
administration of the stem cells to a patient. Nor do Appellants provide any
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evidence or argument that the in vitro example set forth in Example 2 is an
art accepted model for in vivo systems.

CONCLUSION OF LAW
We conclude that the Examiner has established by a preponderance of
the evidence that the Specification fails to enable the method of claim 1. We
thus affirm the rejection of claims 1 and 5-8 stand under 35 U.S.C. § 112,
first paragraph, for lack of enablement.

ISSUE IV
Has the Examiner established by a preponderance of the evidence that
the method as set forth by claim 1 is indefinite?

FINDINGS OF FACT
FF10 The Examiner’s statement of the indefiniteness rejection may be
found at pages 20-21 of the Examiner’s Answer.
FF11 Specifically, according to the Examiner, “[i]t is unclear how the step
of determining a region where labeled stem cells have accumulated relates to
the preamble, ‘aiding in the diagnosis of a human patient.’” (Ans. 20.)

PRINCIPLES OF LAW
“The test for definiteness is whether one skilled in the art would
understand the bounds of the claim when read in light of the specification.”
Miles Laboratories, Inc. v. Shandon, Inc., 997 F.2d 870, 875 (Fed. Cir.
1993). However, “breadth is not to be equated with indefiniteness,” and the
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rejection is reversed. In re Miller, 441 F.2d 689, 693 (CCPA 1971); see also
In re Hyatt, 708 F.2d 712, 714-15 (Fed. Cir. 1983).

ANALYSIS
Appellants argue that there is no requirement that a method claim
must contain a step as to how the method steps relate to the preamble. (App.
Br. 35.)
We agree with Appellants that the ordinary artisan would understand
the metes and bounds of the claim. The Examiner appears to be concerned
with breadth of the preamble and claimed method of diagnosis, but breadth
is not to be equated with indefiniteness.

CONCLUSION OF LAW
We conclude that the Examiner has not established by a
preponderance of the evidence that the method as set forth by claim 1 is
indefinite, and we thus reverse the rejection of claims 1 and 5-8 under 35
U.S.C. § 112, second paragraph, as being indefinite.

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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

alw

THE HECKER LAW GROUP
1925 CENTURY PARK EAST
SUITE 2300
LOS ANGELES, CA 90067