Ex Parte Gray et al

Patent Trial and Appeal Board

Nov 28, 2018

12615033 (P.T.A.B. Nov. 28, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/615,033 11/09/2009
52034 7590 11/30/2018
Parker Highlander PLLC
1120 South Capital of Texas Highway
Bldg. 1, Suite 200
AUSTIN, TX 78746
FIRST NAMED INVENTOR
Peter C. Gray
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.
CLFR:334US 9726
EXAMINER
RAWLINGS, STEPHEN L
ART UNIT PAPER NUMBER
1643
NOTIFICATION DATE DELIVERY MODE
11/30/2018 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):
docket@phiplaw.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte PETER C. GRAY, GIDI SHANI, JONATHAN A. KELBER,
and WYLIE VALE 1
Appeal2017-001821
Application 12/615,033
Technology Center 1600
Before ERIC B. GRIMES, JOHN G. NEW, and JOHN E. SCHNEIDER,
Administrative Patent Judges.
SCHNEIDER, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving the Examiner's
rejection of claims to a method for treating hyperproliferative diseases which
have been rejected as indefinite, for failure to comply with the written
1 Appellants identify the Real Party in Interest as Research Development
Foundation. Appeal Br. 3.
We have considered and herein refer to the Specification of Nov. 9, 2009
("Spec."); Final Office Action of June 19, 2015 ("Final Act."); Appeal Brief
of Jan. 20, 2016 ("Appeal Br."); Examiner's Answer of Sept. 7, 2016
("Ans."); and Reply Brief of Nov. 7, 2016 (Reply Br.").
Appeal2017-001821
Application 12/615,033
description, for lack of enablement, and as obvious over the cited prior art.
We have jurisdiction under 35 U.S.C. § 6(b ).
We AFFIRM.
STATEMENT OF THE CASE
"Cripto ( Cripto-1, TDGF 1) is a small, GP I-anchored signaling protein
[that] has been linked to several aspects of tumor initiation and
progression including increased cellular proliferation, migration, invasion,
tumor angiogenesis and epithelial to mesenchymal transition (EMT)" Spec.
,r 4. "Cripto can bind glucose regulated protein 78 (GRP78)[, which can]
result [in] downstream signaling which promotes the growth of
hyperproliferative cells. Accordingly, the present invention provides
inhibitors of the Cripto/GRP78 interaction which may be used to treat a
disease such as a cancer." Spec. ,r 8.
Claims 4--8, 13, and 15-21 are on appeal. Claim 15 is illustrative and
reads as follows:
15. A method of treating a hyperproliferative disease
in a human subject comprising administering to the subject an
amount of a selective targeting compound that is effective to
inhibit Cripto signaling in hyperproliferative cells that express
glucose regulated protein 78 (GRP78) on their surfaces and
thereby reduce the cells' proliferation, wherein the selective
targeting compound is an antibody that binds within the
sequence region defined by amino acids 19-68 of GRP78 and
inhibits the formation of complexes between human Cripto and
GRP78.
App. Br. 25.
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The claims stand rejected2 as follows:
Claims 4--8, 13, and 15-21 have been rejected under 35 U.S.C. § 112,
second paragraph as indefinite.
Claims 4--8, 13, and 15-21 have been rejected under 35 U.S.C. § 112,
first paragraph for failure to comply with the written description
requirement.
Claims 4--8, 13, and 15-21 have been rejected under 35 U.S.C. § 112,
first paragraph as not enabled.
Claims 13 and 15-20 have been rejected under 35 U.S.C. § 103(a) as
unpatentable over Kelber. 3
Claim 21 has been rejected under 35 U.S.C. § 103(a) as unpatentable
over Kelber in view of Riondel. 4
Claims 4 and 8 have been rejected under 35 U.S.C. § 103(a) as
unpatentable over Kelber in view of Presta. 5
Claim 6 and 7 have been rejected under 35 U.S.C. § 103(a) as
unpatentable over Kelber in view of Tada. 6
Claim 5 has been rejected under 35 U.S.C. § 103(a) as unpatentable
over Kelber in view of Lum. 7
Claims 13 and 15-20 have been rejected under 35 U.S.C. § 103(a) as
unpatentable over Philippova8 in view of Liao9 and Wyder. 10
2 Claims 13 and 15-20 were rejected under 35 U.S.C. § 103(a) as
unpatentable over D. Davidson et al., Kringle 5 of Human Plasminogen
Induces Apoptosis of Endothelial and Tumor Cells through Surface-
Expressed Glucose-Regulated Protein 78, 65 Cancer Res. 4663 (2005).
Final Act. 17. This rejection was withdrawn by the Examiner. Ans. 6.
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3 J. A. Kelber et al., Blockage of Cripto binding to cell surface GRP78
inhibits oncogenic Cripto signaling via MAPK/P 13K and Smad2/3
pathways, 28 Oncogene 2324 (2009) ("Kelber").
4 J. Riondel et al., Therapeutic response to taxol of six human tumors
xenografted into nude mice, 17 Cancer Chemother. Pharmacol. 137 (1986)
("Riondel").
5 L. G. Presta, Engineering of therapeutic antibodies to minimize
immunogenicity and optimize function, 58 Adv. Drug Del. Rev. 640 (2006)
("Presta"). In both the Final Action and the Answer the Examiner refers to
claim 2 as being rejected. Final Act. 54; Ans. 5. However, claim 2 is not
subject to this appeal. See, Final Act. 1, Appeal Br. 3. For purposes of this
appeal, we assume that the Examiner is referring to claim 4 in this rejection.
6 H. Tada et al., In vivo Real-time Tracking of Single Quantum Dots
Conjugated with Monoclonal Anti-HER2 Antibodies in tumors of Mice, 67
Cancer Res. 113 8 (2007) ("Tada").
7L. G. Lum et al., The new face of bispecific antibodies: targeting cancer
and much more, 34 Exp. Hematol. 1 (2006) ("Lum").
8 M. Philippova et al., Identification of Proteins Associating with
Glycosylphosphatidylinositol-Anchored T-Cadherin on the Swface of
Vascular Endothelial Cells: Role for Grp78/BiP in T-Cadherin-Dependent
Cell Survival, 29 Molecul. And Cell. Bio. 4004 (2008) ("Philippova").
9 F. Liao et al., Selective Targeting of Angiogenic Tumor Vasculature by
Vascular Endothelial-cadherin Antibody Inhibits Tumor Growth without
Affecting Vascular Permeability, 62 Cancer Res. 2567 (2002) ("Liao").
10 L. Wyder et al., Increased Expression of H/T-Cadherin in Tumor-
penetrating Blood Vessels, 60 Cancer Res. 4682 (2000) ("Wyder").
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Application 12/615,033
INDEFINITENESS
GRP-78
Issue
The issue with respect to this rejection is whether the Examiner as
correctly determined that the term GRP78 renders the claims indefinite.
The Examiner finds that the term GRP78 describes not one peptide,
but a plurality of peptides. Final Act. 3--4. The Examiner points to the fact
the Appellants previously claimed a human wild-type GRP78 which
indicates that there are at least two different GRP78 peptides. Final Act. 4--
5. The Examiner acknowledges that there is a version of GRP78 described
by GENBANK Accession number NM_005347, however, the Examiner
finds that the claims contemplate other peptides that are structural and/or
functional equivalents of "wild-type GRP78." Final Act. 5. The Examiner
concludes:
Because it cannot be ascertained to which particular
protein the claimed antibody must bind it is submitted that the
claims cannot be unambiguously construed. Accordingly the
claims fail to delineate the metes and bounds of the subject
matter that is regarded as the invention with the requisite clarity
and particularity to permit the skilled artisan to know or
determine infringing subject matter, so as to satisfy the
requirements set forth under 35 U.S.C. § 112, second
paragraph.
Final Act. 6.
Appellants contend that GRP78 is well known as evidenced by the
discussion at paragraphs 45, 46 and 53 of the present Specification. Appeal
Br. 4. Appellants contend that the Examiner has not advanced any evidence
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that more than one human GRP78 exists. Id. Appellants argue that one
skilled in the art would know what is meant by the term.
Principles of Law
"The object of the patent law in requiring the patentee to 'particularly
point out and distinctly claim the part, improvement or combination which
he claims as his invention or discovery' is not only to secure to him all to
which he is entitled, but to apprise the public of what is still open to them."
McClain v. Ortmayer, 141 U.S. 419,424 (1891).
"The test for indefiniteness does not depend on a potential infringer's
ability to ascertain the nature of its own accused product to determine
infringement, but instead on whether the claim delineates to a skilled artisan
the bounds of the invention." SmithKline Beecham Corp. v. Apotex Corp.,
403 F.3d 1331, 1340-1341 (Fed. Cir. 2005).
Claims are not indefinite simply because they may be broad enough to
encompass inoperative embodiments. See Exxon Research and Eng 'g Co. v.
United States, 265 F.3d 1371, 1382 (Fed. Cir. 2001) ("[T]he claims as
written ... may include some inoperable embodiments. . . . However, that is
an issue of enablement, and not indefiniteness. ") ( citations omitted).
Analysis
We have considered the parties' arguments and find that the Examiner
has not established that the use of the term GRP 78 renders the claims
indefinite. Appellants have demonstrated that one skilled in the art would
understand that term refers to a specific peptide with a known sequence.
Appeal Br. 7. As Appellants point out, human peptide GPR78 has a specific
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amino acid sequence that has been assigned a specific GENBANK accession
number. Id. The Specification references several articles which discuss the
binding of antibodies to GRP78 and the role of GRP78 as a transmembrane
receptor. Spec. ,r,r 49--51. We agree with Appellants that one skilled in the
art would understand what is meant by the term human GRP78.
The Examiner contend that since Appellants previously referred to
wild-type human GRP78, there must therefore be more than one type of
human GRP78. Final Act. 4, Ans. 9. The Examiner contends that since
there is more than one type of human GRP78, the claim is indefinite as the
claim does not identify a specific GRP78. Ans. 7.
We find the Examiner's argument unpersuasive. The Examiner has
not advanced any convincing evidence that there is more than one human
GPR78. In addition, Appellants have shown that the structure of human
GRP78 is well-known, and that the art generally recognizes one specific
peptide as constituting GRP78. Appeal Br. 7, Reply Br. 4--5.
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N-20 Epitope
Issue
The issue with respect to this rejection is whether the Examiner has
properly determined that the claims are indefinite in reciting an antibody that
binds with the sequence region defined by amino acids 19---68 of GRP78.
The Examiner find that the claims are indefinite in that the claims
were originally directed to an antibody that binds to the N-20 epitope
whereas the present claim refers to the region defined by amino acids 19---68
oOf GRP78. Final Act. 9. The Examiner contends that the invention as
presently claimed is not the same as what is described. Id.
Appellants contend that the Examiner's rejection is in error in that the
claims do not refer to the N-20 epitope and the Examiner's rejection on that
basis is moot. Appeal Br. 5.
Analysis
We agree with Appellants that the claims are not indefinite. While the
claims may have referred to the N-20 epitope at one time, the claims on
appeal do not use that term. See, Appeal Br. 25 (Claims App'x). Instead,
the claims refer to a sequence region defined by amino acids 19---68 of
GRP78. Id. Thus the issue is whether one skilled in the art would
understand what is meant by that term such that the metes and bounds of the
claims are understood. SmithKline Beecham Corp, 403 F.3d at 1340-1341.
As discussed above, appellants have established that GRP78 is a
peptide with a known structure. The sequence listing of GRP78 is generally
available. Appeal Br. 4. We finds that one skilled in the art can readily
determine which amino acids comprise amino acids 19---68 and therefore
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readily determine the region where the antibodies recited in the claims must
bind.
Conclusion
We conclude that the Examiner has not properly determined that the
claims are indefinite.
WRITTEN DESCIPTION
Issue
The issue with respect to this rejection is whether the Examiner has
properly determined that the claims fail to comply with the written
description requirement.
The Examiner finds that, whereas the claims are directed to any
antibody which binds to the recited peptide sequence, the Specification only
list one such antibody, the N-20 antibody. Final Act. 17. The Examiner also
finds that the claims embrace both monoclonal antibodies and polyclonal
antibodies, whereas the Specification only discloses a single polyclonal
antibody, N-20. Final act. 16. The Examiner concludes
This polyclonal antibody is not adequately representative
of claimed genus of antibodies, which include monoclonal
antibodies, and its description does not permit one skilled in the
art to immediately envisage, recognize or distinguish a
monoclonal antibody that binds to human GRP78 and blocks
the interaction of Cripto and GRP78 in or on the surface of
hyperproliferative cells.
Final Act. 18.
Appellants argue that the written description requirement has been
met in that the under lying antigen corresponding to the claimed antibody
has been fully disclosed. Appeal Br. 7-8. In support of this contention
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Appellants rely on the Federal Circuit's decision in Noelle where the court
stated that "disclosure of an antigen fully characterized by its structure,
formula, chemical name, physical properties, or deposit in a public
depository provides adequate written description of an antibody claimed by
its affinity binding to that antigen." Noelle v. Lederman, 355 F.3d 1343
(Fed. Cir. 2004).
Principles of Law
An adequate written description must contain enough information
about the actual makeup of the claimed products-"a precise definition, such
as by structure, formula, chemical name, physical properties, or other
properties, of species falling within the genus sufficient to distinguish the
genus from other materials," which may be present in "functional"
terminology "when the art has established a correlation between structure
and function." Araid Pharm., Inc. v. Eli Lilly & co., 598 F.3d 1336, 1350
(Fed. Cir. 2010) (en bane).
Analysis
We find that the Examiner has the better argument. The Specification
describes only one polyclonal antibody which binds to the recited region on
GRP78. Appellants point to nothing in the Specification where the complete
or partial structure of the N-20 antibody or other properties other than it
binding affinity are disclosed. Absent such a disclosure, the written
description requirement is not met.
Appellants' reliance on Noelle is misplaced. While the court in Noelle
did discuss what is referred to as the "newly characterized antigen" test, the
Federal Circuit has recently rejected such a test. Amgen Inc. v. Sanofi, 872
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F.3d 1367, 1378-79 (Fed. Cir. 2017). At issue in Amgen was the district
court's jury instruction which read
In the case of a claim to antibodies, the correlation between
structure and function may also be satisfied by the disclosure of
a newly characterized antigen by its structure, formula,
chemical name, or physical properties if you find that the level
of skill and knowledge in the art of antibodies at the time of
filing was such that the production of antibodies against such an
antigen was conventional and routine.
Id. at 1376. The Federal Circuit concluded that the instruction was "not
legally sound and is not based on any binding precedent. Id.
In reaching its conclusion the Federal Circuit reviewed the cases
which purported to set forth the newly characterized antigen test including
Noelle. Id. at 1376-77. The court concluded that in each of the prior cases
the reference to the newly characterized antigen test was dicta and not
binding precedent. Id.
The Federal Circuit went on to find that the newly characterized
antigen test ran afoul of the Federal Circuit's precedent inAraid. Id. at
1378. The court noted that the focus of the inquiry is whether the written
description contains enough information about the claimed products. Id.
The court held that describing the antigens, which was not the claimed
invention did not satisfy the written description requirement. Id.
The claims currently on appeal present the same deficiency as the
claims in Amgen. Appellants attempt to describe the invention by describing
something that is not the invention: viz., the antigens to which the antibodies
may bind. Appellants have not pointed to anything else in the disclosure
that describes the antibodies as required by the test set forth in Ariad.
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Conclusion of Law
We conclude that the Examiner properly found that the claims do not
comply with the written description requirement.
ENABLEMENT
Issue
The issue with respect to this rejection is whether the Examiner
properly determined that the claims are not enabled.
The Examiner finds that the claims are not enabled for the full scope
of the claims. Final Act. 40. The Examiner finds that while the
Specification enables one skilled in the art to treat the specific disorders
specified therein, it does not enable one skilled in the art to treat all
proliferative diseases. Id. The Examiner finds that the Specification does
not enable one skilled in the art to treat diseases where GRP78 is not present
on the surface of the cells. Final Act. 42. The examiner concludes that "one
skilled in the art cannot predict whether most types of hyperproliferative
diseases can be effectively treated using the claimed invention, or not, on the
basis of the disclosure alone without a need to first perform additional,
undue and unreasonable experimentation." Final Act. 44.
The Examiner also contends that the claims are not enabled in that it
would require undue experimentation to discover which antibodies bind to
the region of GRP78 recited in the claims. Ans. 58. The Examiner finds
that only one antibody, the N-20 polyclonal antibody is described in the
Specification and that it would take undue experimentation to locate other
antibodies. Id. at 59.
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Appellants contend that the Examiner's rejection ignores the
limitation that the target cells of the claimed method are ones that express
GRP78 on the surface. Appeal Br. 14. Appellants contend that
determination of whether a given hyperproliferative cell expresses GRP78
on its surface is a simple and straight forward procedure that is within the
skill of one in the art. Appeal Br. 14--16.
With respect to raising antibodies which bind to the recited region of
GRP78, Appellants contend that
The relative skill of those in the art, as of the filing date sought
by Appellant, was such that It would have been relatively easy
to produce a plurality of either polyclonal or monoclonal
antibodies that specifically bind to human GRP78 by
Immunizing an animal ( e.g. a mouse) with an immunogen
comprising the portion of human GRP78 spanning amino acids
19-68. All of such anti-human GRP78 antibodies produced by
this method would be expect to bind specifically to the region
of human GRP76 spanning amino acids 19-68.
Reply Br. 11, quoting Ans. 57.
Principles of Law
"[ A ]n invention may be enabled even though it has not been
described." University of Rochester v. G.D. Searle & Co., 358 F.3d 916,
921 (Fed. Cir. 2004).
The enablement requirement is often more indulgent than
the written description requirement. The specification need not
explicitly teach those in the art to make and use the invention;
the requirement is satisfied if, given what they already know,
the specification teaches those in the art enough that they can
make and use the invention without 'undue experimentation.'
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Amgen, Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d 1313, 1334
(Fed. Cir. 2003).
Analysis
We have considered the parties arguments and conclude that
Appellants have the better position. As Appellants point out, the claims are
limited to treating proliferative diseases where the proliferative cells express
GRP78 on their surface. Appeal Br. 25 (Claims App'x). As Appellants
point out, one skilled in the art can readily screen cells to determine if they
express GRP78 on their surface. The Examiner has offered no convincing
evidence or argument to show that screening cells for the expression of
GRP78 on their surface would involve undue experimentation other than the
naked statement that it would. See, Final Act. 44.
With respect to the production of antibodies which would work in the
claimed method, as the Examiner stated in the Answer, raising such
antibodies would be well within the skill of one in the art. Ans. 57. Thus it
would not require an undue amount of experimentation for one skilled in he
art to develop antibodies meeting the requirements of the claims.
Conclusion of Law
We conclude that the Examiner has not established that the claims are
not enabled.
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OBVIOUSNESS
Kelber alone or in Combination
Issue
Appellants have presented the same arguments for all of the rejections
based on Kelber, namely, that Kelber is not prior art against the pending
claims. Appeal Br. 16-17. Therefore, we shall treat all these rejection
together.
The issue with respect to the rejection based on Kelber is whether the
present claims are entitled to the priority benefit of the filing date of
Appellants provisional application, 11 which was filed before the publication
of Kelber. 12
Appellants contend that the provisional application comprises a
disclosure consistent with the disclosure set forth in the instant Specification.
Appeal Br. 16. Appellants also contend that the rejection for written
description and enablement are improper. Id.
The Examiner contends that since the claims are not enabled and do
not comply with the written description requirement, the claim of priority
fails. Ans. 77.
Principles of Law
"In order to gain the benefit of the filing date of an earlier application
under 35 U.S.C. § 120, each application in the chain leading back to the
earlier application must comply with the written description requirement of
11 US Application No. 61/112,579, filed Nov. 7, 2008.
12 Kelber was published in June 2009.
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35 U.S.C. § 112." Lockwood v. American Airlines, Inc., 107 F.3d 1565,
1571 (Fed. Cir. 1997).
"A reference patent is only entitled to claim the benefit of the filing
date of its provisional application if the disclosure of the provisional
application provides support for the claims in the reference patent in
compliance with§ 112, ,r 1." Dynamic Drinkware, LLC v. National
Graphics, Inc., 800 F.3d 1375, 1381 (Fed. Cir. 2015).
Analysis
In light of our conclusion above that the present claims do not comply
with the written description requirement we conclude that Appellants' claim
of priority to its provisional application fails. For this reason we find that
Kelber is available as prior art to the claims. We affirm the rejections based
on Kelber on this basis.
Philippova in view of Liao and Wyder.
Issue
The issue with respect to this rejection is whether a preponderance of
the evidence supports the Examiner's conclusion that the subject matter of
claims 15 and 15-20 would have been obvious to one of ordinary skill in the
art over Philippova combined with Liao and Wyder.
The Examiner finds that Philippova teaches the use of anti-human
GRP78 antibodies to block then-terminal end of GRP 78 such that the
activity of T-cadherin is reduced. Final Act. 65---66. The Examiner finds
that Philippova teaches the reduction of T-cadherin activity results in tumor
angiogenesis. Id.
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The Examiner finds that Liao teaches that selective targeting "of
angiogenic tumor vasculature by an anti-vascular endothelial-cadherin (VE-
cadherin) antibody is capable of inhibiting tumor growth in a subject. Final
Act. 66.
The Examiner finds that Wyder teaches the use of selective antibodies
to limit the action of T-cadherin to promote neovascularization in tumors.
Id.
The Examiner concludes
It would have been obvious to one ordinarily skilled in
the art at the time of the invention to use the antibody described
by the prior art (i.e., the goat anti-human GRP78 polyclonal
antibody designated N-20) to treat lung metastases with
neovasculature comprising endothelial cells expressing GRP78
and T-cadherin at the cell surface in a subject by administering
an effective amount of the antibody to the subject to block the
activity of GRP78 (i.e., the interaction of GRP78 and T-
cadherin) in order to inhibit the proliferation of the endothelial
cells and interfere with neovascularization of the tumors. One
ordinarily skilled in the art would have been motivated to do so
in order to treat lung cancer metastases in the subject.
The prior art does not expressly teach that the antibody is
capable of blocking binding of Cripto to GRP78 so as to inhibit
Cripto signaling in the cells. Nonetheless, since the process of
the prior art is materially and manipulatively indistinguishable
from the claimed method, absent a showing of any unobvious
difference, the process of the prior art inherently leads the
claimed outcome, i.e., the inhibition of binding of GRP78 to
Cripto, as well as Cripto signaling in the cells contacted with
the antibody. See Ex parte Novitski 26 USPQ 1389 (BPAI
1993).
Final Act. 66-67.
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Appellants contend that while Philippova discloses antibodies which
bind to the N-tenninal portion of GRP78, Philippova does not teach or
suggest using the antibodies to treat cancer. Appeal Br. 22. Appellants
contend that the secondary references do not teach using antibodies to
prevent Cripto from binding to GRP78 but instead relate to directly blocking
the action of T-cadherin. Appeal Br. 23. Appellants argue that the
Examiner improperly used hindsight in making the rejection. Id.
Principles of Law
"In rejecting claims under 35 U.S.C. § 103, the examiner bears the
initial burden of presenting a prima facie case of obviousness. Only if that
burden is met, does the burden of coming forward with evidence or
argument shift to the applicant." In re Rijckaert, 9 F.3d 1531, 1532 (Fed.
Cir. 1993).
Analysis
We have considered the parties' arguments and the evidence of record
and conclude that the Examiner has not established a prima facie case of
obviousness. While Philippova teaches binding of antibodies to the N-
terminal region of GRP78, the Examiner has not shown that this region is
the same as that recited in the claims nor has the Examiner shown any
teaching or suggestion that binding at the N-terminal end would inhibit
binding of Cripto to GRP78.
The Examiner contends that the antibodies used in Philippova would
inherently block the binding of Cripto in that the antibodies bind to the same
region of GRP78 as Cripto. Ans. 86. While this may be true, we remain
unpersuaded.
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As Appellants point out, the claims are directed to a method for
treating hyperproliferative diseases using antibodies to block the binding of
Cripto to GRP78 not the antibodies themselves. Reply 18. While the
antibodies in Philippova may act to prevent Cripto from binding to GRP78,
that inherent trait does not make the use of the antibodies to prevent Cripto
binding obvious. The Examiner has offered no evidence that Cripto binds to
the same region of GRp78 as the antibodies used in Philippova. See, Ans.
83-88. Nor has the Examiner offered any evidence which would teach or
suggest using the antibodies to block the binding of Cripto to GRP78. Id.
The present situationis similar to that addresses in Perricone. In
Perricone, the Federal Circuit distinguished between the topical application
of a lotion to skin generally to prevent sunburn, and the topical application
of a lotion to treat sunburned skin, finding that the "issue is not ... whether
[the prior art] lotion if applied to skin sunburn would inherently treat that
damage, but whether Pereira discloses the application of its composition to
skin sunburn. It does not." Perricone v. Medicis Pharm. Corp., 432 F.3d
1368, 1378 (Fed. Cir. 2005).
As in Perricone, the present claims are for a method for using the
antibodies, not the antibodies themselves. Thus, while the antibodies
disclosed in the references may inherently possess the ability to bind to the
specified region of GRP78, that ability does not render obvious claims to a
method for using the antibodies. The Examiner has not persuasively shown
that the references would lead to using the disclosed antibodies to treat
cancer.
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Conclusion
We conclude that a preponderance of the evidence does not support
the Examiner's conclusion that the subject matter of claims 13, and 15-20
would have been obvious over Philippova combined with Liao and Wyder.
SUMMARY
We reverse the rejections under 35 U.S.C. § 112, second paragraph
for indefiniteness.
We affirm the rejection under 35 U.S.C. § 112, first paragraph for lack
of written description.
We reverse the rejections under 35 U.S.C. § 112, first paragraph for
lack of enablement.
We affirm the rejections under 35 U.S.C. § 103(a) over Kelber alone
or in combination with other references.
We reverse the rejection under 35 U.S.C. § 103(a) over Philippova
combined with Liao and Wyder.
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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