Ex Parte Tang et al

Patent Trial and Appeal Board

Feb 28, 2019

14471727 (P.T.A.B. Feb. 28, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
14/471,727 08/28/2014 Y. Tom Tang
22428 7590 03/04/2019
Foley & Lardner LLP
3000 K STREET N.W.
SUITE 600
WASHINGTON, DC 20007-5109
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.
039386-2342 3989
EXAMINER
SEHARASEYON, JEGATHEESAN
ART UNIT PAPER NUMBER
1647
NOTIFICATION DATE DELIVERY MODE
03/04/2019 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):
ipdocketing@foley.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte Y. TOM TANG, PREETI G. LAL, JENNIFER L. JACKSON,
HENRY YUE, KARL J. GUEGLER, NEIL C. CORLEY,
OLGA BANDMAN, CHANDRA S. ARVIZU, GINA A. GORGONE,
MATTHEW R. KASER, MARIAH R. BAUGHN, and
JANICE K. AU-YOUNG
Appeal2017-003227
Application 14/4 71, 727 1
Technology Center 1600
Before JOHN G. NEW, JOHN E. SCHNEIDER, and
RACHEL H. TOWNSEND, Administrative Patent Judges.
TOWNSEND, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to an
antibody that specifically binds to a polypeptide comprising the amino acid
sequence of SEQ ID N0:74, which have been rejected as not being
supported by a specific and substantial asserted utility, failing to meet the
how to use enablement requirement, and as anticipated. We have
jurisdiction under 35 U.S.C. § 6(b ).
1 Appellants identify the real party in interest as Incyte Corporation.
(Appeal Br. 2.)
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We affirm.
STATEMENT OF THE CASE
Appellants' have substantially purified 79 polypeptides that they refer
to as "human transmembrane proteins" (HTMPN). (Spec. 10-11, 23.) They
have derived the nucleic sequence encoding these polypeptides and predict
transmembrane sequences. (Spec. 14, 23-24, see also Tables 1 and 2.) SEQ
ID NO: 153 is the polynucleotide sequence encoding the polypeptide of SEQ
ID NO: 74. (Spec at 77 (Table 1).) Appellants have also detected tissue
categories expressing these HTMPNs using northern analysis. (Spec. 24, 60,
93 (Table 3).) SEQ ID NO: 153 was found to be expressed in reproductive,
nervous, and gastrointestinal tissue. (Spec. 93 (Table 3).) The Specification
does not disclose any biological function or activity for any of these
HTMPNs. Table 3 of the Specification simply lists, in the third column,
diseases, disorders, or conditions associated with the tissues in which the
HTMPN was found to be expressed. (Spec. at 23-24.)
Claims 21 and 23-33 are on appeal. 2 Claim 21 is representative and
reads as follows:
21. An isolated antibody or fragment thereof that specifically
binds to a polypeptide comprising the amino acid sequence of
SEQ ID NO: 7 4.
(Appeal Br. 12.)
2 Claims 34--37 are directed to a non-elected invention and have been
withdrawn. (Final Action 2.)
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The following grounds of rejection by the Examiner are before us on
review:
Claims 21 and 23-33 under 35 U.S.C. § 101 as not being supported by
a specific and substantial or credible real world asserted utility.
Claims 21 and 23-33 under 35 U.S.C. § 112, 1st paragraph as the
specification fails to adequately teach how to use the claimed invention.
Claims 21 and 23-33 under 35 U.S.C. § 102(b) as anticipated by
McNagny. 3
DISCUSSION
§ 101 Lack of Utility and§ 112, f 1 Lack of Enablement
There is a common issue presented with regard to the rejections under
35 U.S.C. § § 101 and 112, ,r 1, which is whether the claimed antibody has a
specific and substantial utility. We treat both rejections together.
Furthermore, because Appellants have not argued the claims separately, we
focus our analysis on representative claim 21. 37 C.F.R. § 4I.37(c)(l)(vii).
The Examiner finds that the Specification discloses that the inventors
"are in possession of a novel protein of SEQ ID NO: 74." (Final Action 5.)
The Examiner, further finds, however, that the Specification has only
provided a partial description of the protein "in the form of a predicted
amino acid sequence" to which the claimed antibody is to specifically bind,
and "does not disclose the physical or structural properties of that protein,"
or "the biological role" of it, "or its significance." (Final Action 3.) The
Examiner notes that, while the Specification indicates that analytical
methods have shown that the claimed antibody that binds to the polypeptide
3 McNagny et al., US 7,833,733 B2, issued Nov. 16, 2010.
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of SEQ ID N0:7 4 "has consensus sequences or specific domains that are
homologous to 2-membrane spanning signal peptide containing
transmembrane protein[,]" "there is no actual and specific significance that
can be attributed to said novel polypeptides identified in the specification,
except the prophetic recitation of potential uses, which include the use in
diagnosis, treatment, or prevention of immune, reproductive, smooth muscle,
neurological, gastrointestinal, developmental, and cell proliferative disorders
(page 23, lines 26-30)." (Id. at 3--4.) The Examiner finds that "[t]he instant
specification fails to make any assertions regarding biological activity or
asserted uses based on this statement of structural similarity." (Id. at 4.)
The Examiner further finds that signal peptide containing
transmembrane proteins are noted in the Specification to include a wide
range of proteins as follows: "G-protein coupled receptors, scavenger
receptors, tetraspanins, tumor antigens, ion channels, proton pumps, ABC
transporters, membrane proteins associated with intracellular
communications, endoplasmic reticulum membrane proteins, mitochondrial
membrane proteins, lymphocyte and leukocyte membrane proteins,
apoptosis-associated membrane proteins, and tumorgenesis ( see pages 3-10
of the specification)." (Id. at 6.) And the Examiner further finds that "[t]he
specification does not assert that the protein encoded by the claimed
polynucleotide is a member of a protein family." (Id.) The Examiner points
to articles that postdate the earliest claimed effective filing date of the
present Application on appeal (e.g., May 29, 1998) that state that the type of
similarity of structure described in the Specification does not support
assigning any particular function to the novel polypeptide SEQ ID NO: 7 4.
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(Id. at 6-7 (citing Attwood4 and Skolnick5).) Indeed, finds the Examiner,
the relevant scientific publications indicate that "[ e ]ven in situations where
there is some confidence of a similar overall structure between two proteins,
[ which is not the case here] only experimental research can confirm the
artisan's best guess as to the function of the structurally related protein."
(Id.)
Moreover, the Examiner finds that "the antibodies of the instant
invention cannot be linked to a disease state or treating diseases listed in
page 37, line 25 to page 40, line12." (Id. at 4.) That is "[i]n the absence of
knowledge of what the protein of SEQ ID NO: 74 is, what function the
protein has, or the biological significance of this protein, there is no
immediately obvious patentable use for the antibody of the instant
invention." (Id. at 7.) The Examiner concludes that "[s]ince the instant
specification does not disclose a credible 'real world' use for claimed
antibody to [the] protein of SEQ ID NO: 74, then the claimed invention as
disclosed does not meet the requirements of 35 U.S.C. §101 as being
useful." (Id.)
The Examiner further addresses the assertion during prosecution that
"the claimed antibody has a specific, substantial and credible utility as a
tissue marker in applications such as forensic work, stem cell differentiation,
or biopsy sample analysis." (Id. at 8-11.) The Examiner notes that there is
no assertion in the Specification that "the claimed antibody that specifically
4 Attwood, The Babel of Bio informatics, 290 Science, 4 71--4 73 (2000)
5 Skolnick et al, From Genes to Protein Structure and Function: Novel
Applications of Computational Approaches in the Genomic Era, 18(1)
Trends in Biotech., 34--39 (2000)
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binds a polypeptide comprising the amino acid sequence of SEQ ID NO: 74
can be used or should be used as tissue markers for any particular tissue."
(Id. at 9.) That is so, finds the Examiner, even though the Specification
states: "Northern analysis shows the expression of this sequence in
reproductive, nervous, and gastrointestinal cDNA libraries. Approximately
88.5% of these libraries are associated with cell proliferation, and 15.4%
with inflammation." (Id.) The Examiner notes that because the
polynucleotide encoding the polypeptide of SEQ ID NO: 74 (i.e., SEQ ID
NO: 153) is found in each of reproductive, nervous, and gastrointestinal
libraries, it cannot be used as a marker for tissue in a single one of those
categories. (Id.) The Examiner finds that the claimed antibodies "could be
used to determine what kind of tissue a sample is NOT (based on lack of
expression from certain libraries) [.]" (Id.) The Examiner notes that "there
is no evidence or line of reasoning" in support of the assertion that the
specific binding of the claimed antibody to a polypeptide of SEQ ID NO: 74
that is selectively expressed in reproductive, nervous, and gastrointestinal
provides for the claimed antibody having a specific, substantial and credible
utility as a tissue marker in applications such as forensic work, stem cell
differentiation, or biopsy sample analysis. (Id. at 10.) The Examiner notes
that the Specification does not provide "guidance on how assessment of an
unknown tissue sample as being one of reproductive, nervous and
gastrointestinal tissues would provide immediate benefit to one of ordinary
skill in the art at the time the invention was made." (Ans. 11.) The
Examiner further finds that "[ t ]he expression data presented in the instant
application does not even permit the skilled artisan to make a determination
that a particular tissue type was in hand; in that 'reproductive' includes
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several different tissue types such as uterine and ovarian. This is also true
for gastrointestinal and nerve tissues[.]" (Id. at 11-12.) The Examiner
further explains that "[ t ]he prophetic examples [ of use in forensic work,
stem cell differentiation, or biopsy sample analysis] find no support in [the]
art at the time of the instant invention." (Id. at 12.) The Examiner
concludes that in light of the fact that the antibody "cannot be used to
determine a tissue type, but rather, only a subset of potential tissues from a
list of 11 tissue types[,]" that there is not a specific or substantial utility.
(Ans. 13-15, Final Action at 10-11.)
We agree with the Examiner's factual findings and conclusion that the
claimed invention lacks utility.
Related Case Discussion
We note that utility is an issue that has been raised in application's
from which this application claims continuity, and also in a similar
application with similar disclosure and overlapping inventorship. Appellants
direct our attention to one of them, Ex parte Tang, Appeal No. 2011-002119
(November 30, 2011) (Appeal Br. 6) (the 2119 Appeal), and the Examiner
refers us to another Ex parte Lal, Appeal No. 2011-005611 (August 29,
2012) (Ans. 9). We find there is at least one other appeal of relevance.
In particular, Application 09/700,590, to which the present application
on appeal claims continuity from, whose claims were directed to an isolated
polypeptide comprising the amino acid sequence of SEQ ID NO: 22, was
rejected for lack of utility. Ex Parte Lal, Appeal No. 2006-1274 (the 2006
Appeal). In that case, one assertion of utility was premised on similarity of
SEQ ID N0:22 to mouse Ring3 protein-a protein with a known role in cell
proliferative and immune disorders-, based on 57% homology over 548
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amino acid residues and the presence of a bromodomain-a domain found in
various transcriptional regulators. (2006 Appeal at 6-7.) The panel
explained that the fact of 57% homology over part of the mouse Ring3,
where human Ring3 and mouse Ring3 are known to be 96.4% identical over
the entire 805 amino acid sequence, demonstrates that the claimed
polypeptide is not human Ring3. (Id. at 8.) The panel explained that while
"it is reasonable to conclude that" the polypeptide "is somehow related[,
e.g., shares an ancestral gene at some point in the past,] to mouse Ring 3, the
sequence similarity and relatedness does not establish patentable utility".
(Id. at 7-8.) Appellants in that case also asserted utility that was not
premised on how the polypeptide functions: that utility was premised on
"numerous practical, beneficial uses in [gene expression monitoring
applications, e.g.,] toxicology testing, drug development, and the diagnosis
of disease, none of which requires knowledge of how the polypeptide coded
for by the polynucleotide actually functions." (Id. at 8-9.) Appellants
provided a declaration in support of such utilities. (Id. at 9.) The panel
explained that such generic utilities "are 'merely hypothetical possibilities,
objectives with the claims [ cDNAs] ... could possibly achieve, but none for
which they have been used in the real world."' (Id.) The panel determined
that the asserted utilities were not, therefore, substantial. Moreover, the
panel explained that any cDNA transcribed from any gene in the human
genome could be used in the same way, and thus the utilities were not
specific. (Id. at 10.)
In Application 11/594,148 (the application at issue in Ex parte Tang,
the 2119 Appeal), to which the present application on appeal claims priority,
and whose claims were directed to an isolated polynucleotide encoding a
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polypeptide comprising an amino acid sequence having at least about 95%
sequence identity to the full-length of SEQ ID NO: 74 was also rejected for
lack of utility. 2119 Appeal at 1. In a split decision, the utility rejection was
reversed. A majority of the panel found that the assertion of utility as a
tissue marker for nervous, reproductive, and gastrointestinal tissue in
forensic work, stem cell differentiation, or to confirm the identity of biopsy
tissue or what the tissue is not, was not rebutted by the Examiner, and was
sufficient to meet the low utility threshold. (2119 Appeal at 7.) The
dissenting judge, however, pointed out where the Examiner explained with
scientific reasons why the tissue marker use is not specific or substantial and
that Appellants' did not provide counter evidence or reasoning why a marker
which does not uniquely identify a tissue but rather only identifies a tissue as
one out of three possibilities would be useful in forensic work, stem cell
differentiation or biopsy confirmation. (2119 Appeal (Fredman dissent) at
12-13.) The dissent poses the question "how many tissues can a
polynucleotide be expressed and remain viable as a 'tissue marker"'? (Id. at
14.) The dissenting judge noted that Appellants asserted that B-actin, which
is expressed in multiple tissues, but not all tissues, lacks utility as a tissue
marker. (Id.)
Appeal No. 2011-005611, (the 2012 Ex parte Lal case to which the
Examiner refers in the present appeal), concerned claims in Application
11/3 86,937, with claims to a polypeptide similar to those in the 2119 Appeal
and with a Specification having the same minimal disclosure as to function
and structure for such a polypeptide as in the 2119 appeal. (Application
11/386,937 Ans. 4 ("The instant application has provided a description of an
isolated DNA encoding a protein and the protein encoded thereby. The
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instant application does not disclose the biological role of this protein or its
significance ... The specification states that the claimed polynucleotide
encodes a protein which shares 24% identity with rat OX-45 antigen
preprotein, but makes no further statement or assertion regarding this
structural relationship.").) Appellants in that case, just as in the present
appeal and the 2119 Appeal, asserted utility of the invention as a tissue
marker. (Application 11/386,937 Appeal Br. 10, Ans. 10.) In a unanimous
opinion post-dating the 2119 Appeal, the same panel as that in the 2119
Appeal affirmed the lack of utility for the reasons asserted by the Examiner.
(Appeal No. 2011-005611 Decision at 2.) Those reasons were the same as
discussed by the dissent in the 2119 Appeal. (Application 11/386,937 Ans.
at 10-13.)
Appellants argue that, in light of the decision in the 2119 appeal, we
should find "an antibody that specifically binds to the same polypeptide
(SEQ ID N0:74) to possess at least the same utility as a tissue marker
identifier." ( Appeal Br. 7.) We decline to render our conclusion on utility in
this case solely on the basis of the split decision in the 2119 appeal. It is
well-settled that each case is decided on its own facts and necessarily
involves the exercise of reasoned discretion. See In re Gyurik, 596 F .2d
1012, 1018, nl 5 (CCP A 1979) ("In reviewing specific rejections of specific
claims, this court does not consider allowed claims in other applications or
patents.") The disposition of the 2119 appeal involves different claims than
the ones on appeal here and it is not a precedential decision. Furthermore,
that decision was not unanimous in its holding that the asserted utility of
being a tissue marker is a substantial and specific utility for the polypeptide
comprising an amino acid sequence of SEQ ID NO: 74. Additionally,
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Appeal No. 2011-005611, decided after the 2119 Appeal and involving a
similar polypeptide claim and a specification having a similar disclosure as
in the 2119 appeal, unanimously affirmed the Examiner's rejection of lack
of utility under 35 U.S.C. § 101 for the same reasons provided in the dissent
in the 2119 appeal, and by the same panel of judges as the 2119 panel. We
provide an independent review of the utility issue based on the facts
presented in this case and the legal framework explained below.
Legal Framework
Section 101 provides: "Whoever invents ... any new and useful ...
composition of matter ... may obtain a patent therefor .... " (Emphasis
added). In other words, a patent cannot be granted where utility has not
been disclosed or is not readily apparent.
The Supreme Court announced inBrennerv. Manson, 383 U.S. 519
( 1966) what is required to establish usefulness under section 101, stating:
The basic quid pro quo contemplated by the Constitution and
the Congress for granting a patent monopoly is the benefit
derived by the public from an invention with substantial utility.
Unless and until a process is refined and developed to this point
- where specific benefit exists in currently available form-
there is insufficient justification for permitting an applicant to
engross what may prove to be a broad field.
Brenner, 383 U.S. at 534--35 (emphases added). Thus, the utility
requirement under § 101 must be substantial and specific. In re Fisher, 421
F.3d 1365, 1371 (Fed. Cir. 2005).
"Courts have used the labels 'practical utility' and 'real world' utility
interchangeably in determining whether an invention offers a 'substantial'
utility." Id. "[A]n application must show that an invention is useful to the
public as disclosed in its current form, not that it may prove useful at some
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future date after further research. Simply put, to satisfy the 'substantial'
utility requirement, an asserted use must show that that claimed invention
has a significant and presently available benefit to the public." Id.
"Turning to the 'specific' utility requirement, an application must
disclose a use which is not so vague as to be meaningless." Id.
ANALYSIS
Appellants asserted utility in the Specification for the seventy-nine
"new human transmembrane proteins" discovered is a prophetic recitation of
potential uses "for the diagnosis, treatment, or prevention of immune,
reproductive, smooth muscle, neurological, gastrointestinal, developmental
and cell proliferative disorders." (Spec. 23:27-30.) There is no category of
disorder, much less specific condition, particularly identified for any of the
transmembrane proteins discovered, much less for amino acid SEQ ID NO:
74. Indeed, the Specification does not disclose any biological function or
activity for any of the novel seventy-nine proteins discovered. The
Specification does not even disclose the physical or structural properties of
the predicted protein with the amino acid sequence set forth in SEQ ID NO:
74, though it is identified as a transmembrane protein. (See Spec. 85 (Table
2.) That this amino acid sequence is a transmembrane provides no
information that is specific or substantial as to the utility of the polypeptide
comprising amino acid SEQ ID NO: 7 4, as the Specification discloses that
transmembrane proteins include
• G-protein coupled receptors, which "include receptors for
biogenic amines, lipid mediators of inflammation, peptide
hormones, and sensory signal mediators";
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• scavenger receptors that "may participate in the binding of low
density lipoproteins (LDL) and foreign antigens";
• the transmembrane 4 or tetraspan family, which includes
"platelet and endothelial cell membrane proteins, melanoma-
associated antigens, leukocyte surface glycoproteins, colonal
carcinoma antigens, tumor-associated antigens, and surface
proteins of the schistosome parasites";
• tumor antigens;
• ion channels;
• proton pumps, "a large class of membrane proteins that ...
generate an electrochemical proton gradient across a
membrane"·
'
• ATP-binding cassette transporters, "a superfamily of membrane
proteins that mediate transport and channel functions in
prokaryotes and eukaryotes";
• proteins involved with exocytosis and endocytosis, and those
associated with lysosomes and peroxisomes;
• endoplasmic reticulum membrane proteins;
• mitochondrial membrane proteins;
• lymphocyte and leukocyte membrane proteins; and
• membrane proteins associated with apoptosis and
tumorigenesis.
(Spec. 3-10.) And, the Specification does not even identify a specific family
of transmembrane protein to which the polypeptide comprising amino acid
SEQ ID NO: 7 4 belongs. There is absolutely no evidence of record or any
line of reasoning that would support a conclusion that the amino acid SEQ
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ID NO: 74 was, as of the filing date, useful in any one of the prophetic uses
set forth in the Specification. We agree with the Examiner that the scientific
publications of Attwood and Skolnick support that conclusion. Thus, as the
Examiner explained, any antibody that specifically binds to the polypeptide
that has amino acid SEQ ID NO: 74 also cannot be linked to a disease state
or treating diseases.
Much like was the case in Fisher, in the face of the utility rejection,
here, Appellants have not presented any evidence showing that the amino
acid sequence of SEQ ID N0:7 4 has been used in any of the application
asserted utilities, much less an antibody that specifically binds to that
sequence. Indeed, there does not appear to be any dispute that there is no
substantial and specific utility set forth in the Specification, as Appellants
instead argue that the claimed antibody has utility as a tissue marker
identifier, (Appeal Br. 7-8), which is mentioned nowhere in the
Specification.
It is true that the utility of an invention need not be set forth in the
Specification; however, any such asserted utility must be, like one stated in
the Specification, well-established, and not conjectural. See In re Folkers,
344 F.2d 970,975 (CCPA 1965) ("Since appellants' newly discovered
compounds belong to a class of compounds, the members of which have
become well recognized as useful for a particular purpose because of a
particular property, the only reasonable conclusion is that the new
compounds, also possessing that property, are similarly useful.") see also In
re Kirk, 376 F.2d 936, 945 (CCPA 1967) (noting that neither a product of
only conjectural use nor a process to make such a product are "useful"
within§ 101). As the Federal Circuit explained in Fisher, asserted uses
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which "represent merely hypothetical possibilities, objectives which the
claimed [compound] ... could possibly achieve, but none for which they
have been used in the real world," where such uses are not well-established,
is insufficient to meet the 101 standard absent evidence. Fisher, 421 F.3d at
1373.
Appellants contend that the Supreme Court asserted "'to violate
Section 101 the claimed [invention] must be totally incapable of achieving a
useful result.' Brenner v. Manson, 383 U.S. 519, 534 (1966)" and that as
long as Appellants have provided an identifiable benefit of the claimed
invention that is sufficient. (Reply Br. 4.) However, the Supreme Court did
not articulate so broad a standard. The quoted statement by Appellants was
made by the Federal Circuit in a case addressing a different issue of utility-
whether claimed subject matter was inoperable. Brooktree Corp. v.
Advanced Micro Devices, Inc., 977 F.2d 1555, 1571-73 (Fed. Cir. 1992)
(finding that there was sufficient evidence at trial to support the jury's
finding that the claimed invention was not "totally incapable of'
operability). Thus, not even the Federal Circuit has embraced the broad
standard asserted by Appellants, i.e., any identification of an identifiable
benefit of the claimed invention is sufficient to meet the utility requirement
of§ 101. As discussed above, the standard for the test of usefulness under §
101 is a specific and substantial utility, Brenner, 383 U.S. at 534--35, and not
one that is merely conjectural. Fisher, 421 F.3d at 1374.
The Examiner has explained why Appellants asserted use of the
claimed antibody is conjectural. "[T]he specification provid[ es] no guidance
on how assessment of an unknown tissue sample as being one of
reproductive, nervous, or gastrointestinal tissue would provide immediate
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benefit to one of ordinary skill in the art at the time the invention was
made." (Advisory Action 2; Ans. 11). "The expression data presented in
the instant application does not even permit the skilled artisan to make a
determination that a particular tissue type was in hand." (Ans. 11-12.) What
may be determinable is that the tissue belongs to one of "reproductive,
gastrointestinal or nerve" tissue genera. However, "this does not support an
assertion that the claimed polynucleotides can be used to as markers for
reproductive, nervous or gastrointestinal tissues because it cannot distinguish
between the 3 generic types of tissue as it is found in all three types." (Id. at
9.) The antibodies to the polynucleotide encoding SEQ ID NO: 74 "cannot
be used to confirm a particular tissue because the encoded polypeptide is
expressed in reproductive, nervous, and gastrointestinal tissues." (Id. at 10.)
Thus, the Examiner finds: "It is not clear how one can assert that the claimed
invention is useful as a tissue marker when it cannot be used to determine a
tissue type." (Id. at 10-11 (emphasis added).) "For example, B-actin is a
protein that is expressed in many different tissues and would not be
considered an appropriate tissue marker for this reason." (Id. at 11.)
According to Appellants, "[t]he fact that the polypeptide of SEQ ID
NO: 7 4 is selectively expressed in reproductive, nervous and gastrointestinal
tissues . . . is more than sufficient for applications such as forensic work,
stem cell differentiation testing, or to confirm the identity of biopsy tissue."
(Appeal Br. 7-8.) For example, Appellants assert that one of skill in the art
"may simply wish to narrow down the scope of differentiated tissue types
based on the expression of a tissue marker." (Appeal Br. 8 (emphasis
added); Reply Br. 3.) Appellants further note that in "testing of early stage
stem cell differentiation," "the skilled artisan may simply wish to narrow
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down the scope of differentiated tissue types based on the expression of a
tissue marker." (Id. (emphasis added).)
However, as the Examiner notes, "Appellant[ s have] provided no
evidence to support" that the fact that a protein could be narrowed to be one
of possibly three different classes of tissue "would have provided any
substantial or real world utility to the person of ordinary skill." (Ans. 12). In
other words, what evidence is there that the "narrow[ing] down" to three
classes of tissue is a real-world utility?
Appellants' tissue marker utility in forensics, stem cell differentiation
testing, or identification of biopsy tissues, is simply attorney argument.
"Attorney's argument in a brief cannot take the place of evidence." In re
Pearson, 494 F.2d 1399, 1405 (CCPA 1974). Moreover, the attorney
argument is conjectural as to the utilities asserted. For example the
argument is that "a skilled artisan may simply wish to distinguish a
gastrointestinal tissue sample from a cardiovascular tissue sample" (Reply
Br. 3). Moreover, as the Examiner explained (Ans. 11-12), the antibody
itself would not be able to establish the tissue sample was gastrointestinal, as
the polypeptide to which the antibody binds is also noted to be expressed in
reproductive and nerve tissue.
The attorney argument is not supported by inventor testimony, nor
evidence, such as by articles or other industry testimony. If the attorney
asserted utility were well-established and not simply conjectural one would
expect that inventor testimony, articles, or other industry testimony would
have been readily available and submitted in light of the fact that the
question of utility as to the disclosed novel polypeptides identified in the
present Specification has been ubiquitous throughout the prosecution of this
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family of applications and for at least a decade. See e.g., 2006 Appeal
discussed above (in which Declaration evidence was provided by Appellants
during prosecution to respond to the Examiner's lack of utility rejection in
Application 09/700,590, the great-grandparent application of the application
presently on appeal, as to claims directed to an isolated polypeptide
comprising the amino acid sequence of SEQ ID N0:22).
For the reasons discussed, we find that the Examiner has provided
scientific reasoning to challenge Appellants' asserted utility. We find that
Appellants have not established with evidence that any of the asserted "uses"
are well-established and not conjectural. Just as with the asserted utilities set
forth in the Specification, Appellants have not presented any evidence
showing that the amino acid sequence of SEQ ID N0:74, which cannot
differentiate a specific tissue, has been used as a tissue marker or that such
use is, nevertheless, well-established. In light of the foregoing, we,
therefore, find a preponderance of the evidence on this record supports the
Examiner's position that the claimed invention does not have a substantial
and specific utility.
Appellants argue that the inventors have provided more information in
the Specification regarding the disclosed HTMNPs than the inventors in
Fisher provided regarding the ES Ts involved in that appeal, including things
the Federal Circuit criticized the inventors in Fisher for failing to do in its
reasoning affirming the Board's conclusion that the Examiner had
established that there was a lack of utility, and that such disclosure supports
a finding that the claimed antibody has a specific, substantial and credible
utility. (Appeal Br. 9-10.) We do not find this argument persuasive.
Appellants concede that there is insufficient information regarding function
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of the polypeptide that has amino acid SEQ ID NO: 7 4 to establish a utility
based on such a function. (See Appeal Br. 7-8 (arguing only that the
claimed antibody has utility as a tissue marker identifier).) Moreover, for
the reasons discussed by the Examiner, the gene expression information is
insufficient to establish that the claimed invention has a well-defined and
particular benefit to the public. Furthermore Appellants have not established
with evidence that the fact that a tissue sample could be identified as being
reproductive tissue, gastrointestinal tissue, or nervous tissue, although not
being able to identify by that sequence alone that the tissue belongs to only
one of those categories, would be of any real world benefit, rather than
conjectural benefit, in forensic work, stem cell differentiation or confirming
identity of biopsy tissue.
For the reasons discussed, Appellants do not persuade us that the
Examiner erred in maintaining the rejection of claim 21 as not being
supported by a specific and substantial utility as required under 35 U.S.C.
§ 101.
Claims 23-33 have not been argued separately and therefore fall with
claim 21. 37 C.F.R. § 4I.37(c)(l)(iv).
Moreover, in light of our conclusion regarding the lack of utility, we
also find that the preponderance of evidence supports the Examiner's
conclusion that claims 21 and 23-33 are not enabled as to how to use the
claimed antibody as required under 35 U.S.C. § 112, first paragraph.
II
Anticipation
The Examiner finds claims 21 and 24--33 are anticipated by U.S.
Patent 7,833,733. The Examiner's rejection is premised on the fact that the
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claimed invention is not entitled to the benefit of any of the earlier filed
applications under 35 U.S.C.§ 120 because these earlier applications fail to
meet the how to use requirement under 35 U.S.C. § 112, first paragraph for
the reasons discussed above regarding lack of utility. (Final Action 14.)
Appellants' do not contest any other aspect of the Examiner's anticipation
rejection. (Appeal Br. 11.)
We agree with the Examiner's conclusion regarding lack of benefit.
The Specification of the earlier filed applications is the same as that
supporting the present application. (Id.) As discussed above, we agree with
the Examiner that the Specification fails to enable how to use the claimed
invention. Thus, we agree with the Examiner that the claims cannot claim
benefit under 35 U.S.C. § 120 of the effective filing date of any of the earlier
effective filed applications. Consequently, we also agree with the Examiner
that U.S. Patent 7,833,733 qualifies as prior art.
SUMMARY
We affirm the rejection of claims 21 and 23-33 under 35 U.S.C. § 101
as not being supported by a specific and substantial or credible real world
asserted utility.
We affirm the rejection of claims 21 and 23-33 under 35 U.S.C.
§ 112, 1st paragraph as the specification fails to adequately teach how to use
the claimed invention.
We affirm the rejection of claims 21 and 23-33 under 35 U.S.C.
§ 102(b) as anticipated by McNagny.
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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
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