Ex Parte Hughes et al

Patent Trials and Appeals Board

Apr 25, 2019

11742350 - (D) (P.T.A.B. Apr. 25, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
11/742,350 04/30/2007
51957 7590 04/29/2019
ALLERGAN, INC.
2525 DUPONT DRIVE, T2-7H
IRVINE, CA 92612-1599
FIRST NAMED INVENTOR
Patrick M. Hughes
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.
18197 (OCU) 4711
EXAMINER
DILLAHUNT, SANDRA E
ART UNIT PAPER NUMBER
1646
NOTIFICATION DATE DELIVERY MODE
04/29/2019 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):
patents_ip@allergan.com
pair_allergan@firsttofile.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte PA TRICK M. HUGHES, GERALD W. DEVRIES,
ROBERT T. LYONS, JOHN T. TROGDEN, and SCOTT M. WHITCUP 1
Appeal 2018-003513
Application 11/742,350
Technology Center 1600
Before JOHN G. NEW, JAMES A. WORTH, and
ELIZABETH A. LA VIER, Administrative Patent Judges.
NEW, Administrative Patent Judge.
DECISION ON APPEAL
1 Appellants identify Allergan, Inc., as the real party-in-interest. App. Br. 3.
Appeal 2018-003513
Application 11/742,350
SUMMARY
Appellants file this appeal under 35 U.S.C. § 134(a) from the
Examiner's Final Rejection of claims 1, 5, 15, and 20-32 as unpatentable
under 35 U.S.C. § 112, first paragraph, as lacking written descriptive
support.
We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
NATURE OF THE CLAIMED INVENTION
Appellants' invention is directed to anti-angiogenesis compositions,
and methods of using such compositions, useful for injection into the
vitreous of human eyes. Abstract.
REPRESENTATIVE CLAIM
Claim 1 is representative of the claims on appeal and recites:
1. A method for treating a posterior ocular condition, the
method comprising:
administering into the vitreous of an eye of a mammal
suffering from an ocular condition a composition consisting of:
a therapeutically effective amount of a macromolecular
anti-angiogenic component (MAAC), wherein the MAAC is a
protein,
a viscosity inducing component in an amount effective to
increase the viscosity of the composition to a viscosity at about
25°C of at least 10 cps at a shear rate of about 0.1/second,
wherein said viscosity inducing component is injectable into the
vitreous of a mammalian eye without permanently diminishing
visual acuity,
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sodium chloride,
dibasic sodium phosphate heptahydrate,
monobasic sodium phosphate monohydrate, and
water;
wherein the posterior ocular condition is glaucoma;
and wherein the administering is by subconjunctival,
suprachoroidal, intravitreal or combination thereof.
App. Br. 24.
ISSUES AND ANALYSES
We adopt the Examiner's findings, reasoning, and conclusion that the
claims lack written descriptive support. We address the arguments raised by
Appellants below.
Issue 1
Appellants argue that the Examiner erred in concluding that the
limitation of claim 1 reciting: "a macromolecular anti-angiogenic
component (MAAC), wherein the MAAC is a protein" lacks written
descriptive support in Appellants' Specification. App. Br. 10.
Analysis
The Examiner finds that Appellants' Specification discloses that a
characteristic of the claimed macromolecular anti-angiogenic components
("MAACs") is the ability of the component to reduce the extent of
angiogenesis, particularly vascular endothelial growth factor ("VEGF")-
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associated angiogenesis. Final Act. 4 ( citing Spec. 40). The Examiner finds
that the Specification discloses that MAACs include proteins, polyclonal or
monoclonal antibodies, antibody fragments, such as a monovalent fraction
antigen-binding papain fragment ("Fab") or a bivalent fraction antigen
binding pepsin fragment ("F'ab2"). Id. ( citing Spec. 19). The Examiner
finds that the Specification teaches that the MAACs may comprise one or
more therapeutic agents selected from the group consisting of anti-
angiogenesis compounds, ocular hemorrhage treatment compounds,
macromolecular non-steroidal anti-inflammatory agents, growth factor
inhibitors (e.g., VEGF inhibitors), growth factors, cytokines, and antibodies.
Id. ( citing Spec. 55).
The Examiner further finds that the Appellants' Specification
discloses that anti-angiogenic proteins include endostatin, angiostatin,
tumstatin, pigment epithelium-derived factor, and VEGF trap. Final Act. 4
( citing Spec. 67). The Examiner also determines that the Specification
discloses two compositions, comprising the protein angiogenesis inhibitors
ranibizumab and bevacizumab. Id. ( citing Spec. Ex. 1 ).
The Examiner therefore finds that the claims encompass a broad, even
"vast," genus of "MAAC" proteins that are defined by their common
function of inhibiting angiogenesis and treating glaucoma. Final Act. 5.
However, the Examiner finds, Appellants' Specification only provides
guidance regarding two proteins (ranibizumab and bevacizumab) that are
capable of the required function. Id. The Examiner finds that the
Specification broadly defines the term "MAAC" as any agent that reduces
angiogenesis and teaches that MAACs include agents such as proteins,
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Application 11/742,350
antibodies, antibody mimetics, angiogenesis inhibitors, and receptor
inhibitors. Id.
The Examiner further finds that the Specification defines no express
relationship between the function of the claimed MAACs in reducing
angiogenesis and the structure of the MAACs. Final Act. 5. The Examiner
finds that, with the exception of ranibizumab and bevacizumab, Appellants'
Specification provides no guidance regarding which agents have the function
of treating glaucoma. Id. The Examiner concludes that Appellants'
Specification provides insufficient written description to support the genus
of proteins encompassed by the claims. Id.
Appellants dispute the Examiner's finding that ranibizumab and
bevacizumab are the only anti-angiogenic proteins that are described in their
Specification. App. Br. 11. Appellants point to page 67 of the Specification
which discloses:
In another embodiment of the present viscous MAAC-containing
formulations, the therapeutic component comprises an anti-
angiogenic protein selected from the group consisting of
endostatin (e.g., NCBI Accession Number AAK50626),
angiostatin (e.g., NCBI Accession Number P00747), tumstatin
(NCBI Accession Number AAF72632), pigment epithelium
derived factor (e.g., NCBI Accession Number AAA84914), and
VEGF TRAP (Regeneron Pharmaceuticals, New York). VEGF
Trap is a fusion protein that contains portions of the extracellular
domains of two different VEGF receptors connected to the Fe
region (C-terminus) of a human antibody.
Id. at 12. Appellants assert that a person of ordinary skill would know by
their NCBI Accession numbers that these are all commercially known and
available anti-angiogenic proteins. Id.
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Appellants further argue that their Specification discloses: (1)
detailed methods in how to make anti-VEGF monoclonal antibodies; (2)
where anti-VEGF monoclonal antibodies, such as IMC-l 8FL, can be
obtained from IMCLONE and IMC-1121 Fab; (3) three additional VEGFR
inhibitory antibody mimics, such as the VEGFR-2 inhibitors CT322,
C7Sl00 and C7Cl00 made by Control Therapeutics, Inc.; (4) urokinase
inhibitors; (5) the amino acid sequence ofurokinase inhibitor A6; (6)
another MAAC protein which is combined with cisplatin; (7) variations of
A6, with 80-90 % homology to A6 by amino acid substitutions; (8)
rapamycin, alone and in combination with other drugs such as triamcinolone
acetonide; (9) and cyclophilins, CCI-779 (Wyeth), AP2384 l (Ariad), and
ABT- (Abbott Laboratories). App. Br. 12 (citing Spec. 69-72). Appellants
also assert that their Specification discloses salts of MAACs. Id. ( citing
Spec. 73).
Appellants further point to Example 17 of the Specification, which
describes use of the: (10) antibody mimic ADNECTIN®, an engineered
antibody, including CT-322, C7Sl00, and C7Cl00; and (11) the amino acid
sequence of antibody muMAb VEGF A.4.6.1. App. Br. 12-13 (citing Spec.
56, Fig. 1 ). Appellants argue that all of these compounds are MAACs as
defined by the Specification. Id. at 13.
Appellants also point to the Specification's incorporation by reference
the following prior art: (1) US Ser. No. 11/370,301 (the '"301 application");
(2) US Ser. No. 11/364,687 (the '"687 application"); (3) US Ser. No.
60/721,600 (the '"600 application"); (4) US Ser. No. 11/116,698 (the '"698
application"); (5) US 2005/0074865 Al (the '"865 application"); (6) US
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2004/0259155 Al (the '"155 application"); and (7) US 6,329,386 (the '"386
patent"). App. Br. 13-17.
According to Appellants, the '301 application discloses: "anti-
angiogenic macromolecule, any ocular hemorrhage treatment
macromolecule, any non-steroidal anti-inflammatory macromolecule, any
VEGF inhibitory macromolecule, [and] any peptide," including anti-VEGF
or anti-VEGFR monoclonal antibodies including IMC-18Fl, or an antibody
under the name ofIMC-1121 Fab, and VEGFR inhibitory antibody mimics,
such as the VEGFR-2 inhibitors CT322, C7Sl00 and C7Cl00. App. Br. 13-
14.
Appellants argue that the '687 application discloses anti-VEGF
antibody IMC-18Fl, IMC-1121, F-506 binding proteins everolimus and
pimecrolimus, CCl-779 (Wyeth), AP23841 (Ariad), ABT-578 (Abbot), and
monoclonal antibody fragment F-200 Fab. App. Br. 14-15 ( citing '687
application, pg. 23, 11. 17-19, Example 9 on pg. 62, 1. 15).
Appellants assert that the '600 application discloses antibodies
A.4.6.1, F(ab)l2, and hum III, all of which, Appellants argue, inhibit human
VEGF activity and are MAACs. App. Br. 15. Appellants also point to
Tables 1 and 2 of the '600 application, which disclose: "multiple proteins
for delivery for anti-VEGF therapy," and to Examples 8-18, which disclose
FAB-IMC -1121, F200 Fab, endostatin, and "[other] antiangiogenic
proteins." Id.
With respect to the '698 application, Appellants assert that the
reference discloses ranibizumab, pegatanib, Macugen, endostatin,
angiostatin, tumstatin, pigment epithelium-derived factor, and VEGF Trap,
anti-VEGF antibodies, anti-VEGF receptor antibodies, anti-integrin
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antibodies, and effective fragments thereof. App. Br. 15. Appellants also
argue that the '698 application discloses antibodies IMC- l 8Fl and IMC-
112 lFab, urokinase inhibitor A6, the FK506-binding proteins,
Everolimus and pimecrolimus, CCl-779 (Wyeth), AP23841 (Ariad), and
ABT-578 (Abbott Laboratories), all of which, Appellant contend, are
MAACs, as defined by their Specification. Id. The Appellants also point to
the '698 applications' teaching of the delivery of a number of these
compositions to the eye. Id. at 15-16.
Appellants contend that the '865 application teaches adzymes, which
are defined as: "chimeric protein constructs that join one or more catalytic
domains with one or more targeting moieties," and which may target VEGF.
App. Br. 16.
The '155 application, Appellants argue, discloses two tyrosine
receptor kinases Flt-1 and Flk-1 which bind VEGF with high affinity, and
also A VASTIN®, which the application discloses is an investigational
recombinant humanized antibody to VEGF. App. Br. 1 7.
Finally, Appellants argue that the '386 patent teaches rapamycin and
its analogs, which is described as an "antibiotic, an immunosuppressive
agent, and an anti-angiogenic agent." App. Br. 17.
Appellants therefore assert that the claim term "MAAC" is well
supported by a representative number of MAAC species in the Specification.
App. Br. 17. Indeed, Appellants assert that: "Any protein that has anti-
angiogenic properties will function in treating glaucoma." Id. at 18-19
( emphasis added).
Appellants disagree with the Examiner's finding that there is no
written description of the claimed invention because the: "[S]pecification
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does not provide any evidence that the claimed 'anti-angiogenic' function
correlates with any structural characteristic of the biomolecules
encompassed by the term MAAC." App. Br. 19 (quoting Final Act. 13).
Rather, Appellants argue, the Specification plainly discloses a representative
number of species of MAAC proteins that fall within the scope of the
claims. Id. That alone, Appellants contends, suffices to end the inquiry
under 35 U.S.C. § 112, first paragraph. Id. (citingAriad Pharms. Inc. v. Eli
Lilly & Co., 598 F.3d 1336, 1350 (Fed. Cir. 2010) (en bane)). Appellants
argue that all of the proteins listed in the Specification are of either known
amino acid sequences, because they are commercially available, or the
amino acid sequence is described. Id. at 19-20. According to Appellants, it
is not always the case that species within a genus have common structural
characteristics nor is it required. Id. at 20. Appellants assert that there is no
requirement in patent law that the structure of the claimed MAACs be the
same or similar or have a correlation between structure and function. Id.
Appellants next point to the Examiner's finding that:
[W]hen a claim covers a genus of inventions, the specification
must provide written description support for the entire scope of
the genus. In cases such as this one, where the genus is identified
by reference to a function, the functional identification must be
coupled with a known or disclosed correlation between function
and structure.
App. Br. 20 ( quoting Final Act. 14 ( citing MPEP § 2163). Appellants quote
MPEP § 2163 as stating:
A "representative number of species" means that the species
which are adequately described are representative of the entire
genus. Thus, when there is substantial variation within the genus,
one must describe a sufficient variety of species to reflect the
variation within the genus. Satisfactory disclosure of a
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Application 11/742,350
"representative number" depends on whether one of skill in the
art would recognize that the applicant was in possession of the
necessary common attributes or features possessed by the
members of the genus in view of the species disclosed. For
inventions in an unpredictable art, adequate written description
of a genus which embraces widely variant species cannot be
achieved by disclosing only one species within the genus.
Instead, the disclosure must adequately reflect the structural
diversity of the claimed genus, either through the disclosure of
sufficient species that are "representative of the full variety or
scope of the genus," or by the establishment of "a reasonable
structure-function correlation." Such correlations may be
established "by the inventor as described in the specification," or
they may be "known in the art at the time of the filing date.
App. Br. 20 (internal citations omitted). Appellants argue that, having
allegedly disclosed hundreds of species of disclosed MAAC proteins capable
of [ the inhibition of] angiogenesis in their Specification, the Specification
has provided more than a representative number to support the generic term
MAAC as defined in the claims. Id. at 21.
We are not persuaded by Appellants' arguments. Claim 1 recites, in
relevant part: "a therapeutically effective amount of a macromolecular anti-
angiogenic component (MAAC), wherein the MAAC is a protein .... "
Appellants' Specification defines MAACs thusly:
In particular, the MAACs of the present invention are inhibitors
of angiogenesis, particularly ocular angiogenesis, such as
choroidal neovascularization (CNV) accompanying a condition
such as macular degeneration, in particular, though not
exclusively, exudative macular degeneration, diabetic
retinopathy, retinal ischemia and macular edema.
Spec. 17. Appellants' claims and Specification, therefore, define MAACs
both structurally (i.e., it is a protein), and functionally, i.e., as an inhibitor of
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Application 11/742,350
angiogenesis. The structural categorization, "a protein," is far too broad to
provide a meaningful limitation to the claim other than requiring a common
level of structure, i.e., polypeptide(s) with tertiary/quaternary structure.
There are, of course, protein species without number performing a vast
variety of structural and physiological functions, quite apart from those
capable of inhibiting angiogenesis. The more meaningful limitation within
the scope of the claim 1 is that the protein in question must be "anti-
angiogenic," i.e., an inhibitor of angiogenesis. Consequently, the more
meaningful limitation of claim 1, in that it limits the scope of the claims, and
the one that speaks directly to defining Appellants' claimed invention, is a
functional limitation, viz., that the protein in question must be capable of
inhibiting angiogenesis.
Our reviewing court has held that:
A definition by function, as we have previously indicated, does
not suffice to define the genus because it is only an indication of
what the [ material] does, rather than what it is. It is only a
definition of a useful result rather than a definition of what
achieves that result. ... The description requirement of the patent
statute requires a description of an invention, not an indication of
a result that one might achieve if one made that invention.
Accordingly, naming a type of material generally known to exist,
in the absence of knowledge as to what that material consists of,
is not a description of that material.
Regents of the Univ. of California v. Eli Lilly & Co., 119 F.3d 1559, 1568
(Fed. Cir. 1997) (internal citations omitted); see also In re Wilder, 736 F.2d
1516, 1521 (Fed. Cir. 1984) (affirming rejection because the specification
does "little more than outlin[ e] goals appellants hope the claimed invention
achieves and the problems the invention will hopefully ameliorate").
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Consequently, the Federal Circuit has explained, with respect to the written
description requirement of the first paragraph of Section 112:
[A] sufficient description of a genus instead requires the
disclosure of either a representative number of species falling
within the scope of the genus or structural features common to
the members of the genus so that one of skill in the art can
"visualize or recognize" the members of the genus. We explained
that an adequate written description requires 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. We have
also held that functional claim language can meet the written
description requirement when the art has established a
correlation between structure and function.
Ariad, 598 F.3d at 1350 (internal citations omitted). Appellants'
Specification does not meet any of these requirements.
Appellants argue that their Specification has fulfilled the written
description requirement of Section 112 because it discloses, either directly or
by incorporation, a representative number of species of MAACs. However,
Appellants' argument begs the fundamental question of what is meant,
precisely, by inhibition of angiogenesis. As the Examiner observes,
angiogenesis is a complex physiological signaling cascade that results in
generation of new blood vessels. See Ans. 15; see also Spec. 6 ("A novel
treatment for macular degeneration is to use a MAAC, such as a VEGF
inhibiting aptamer, or other VEGF-inhibiting compound, such as a [sic] to
stop the main signaling cascade for angiogenesis, thereby preventing these
symptoms"). Consequently, the scope of Appellants' claimed genus of
MAACs ( and therefore of claim 1) would be capable of inhibiting
angiogenesis at any stage of the cascade. However, Appellants'
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Specification discloses no evidence that the anti-angiogenic species
disclosed in their Specification are representative of the scope of possible
inhibitors of angiogenesis, as claimed.
In other words, although Appellants' Specification defines MAACs as
being capable of inhibiting angiogenesis, the Specification fails to identify
every possible means of inhibiting the angiogenic process and disclosing a
species of MAAC that would inhibit that process. As such, the disclosures
of Appellants' Specification fail to identify the genus MAAC in such a way
that a person of ordinary skill in the art could visualize or recognize the all
of the members of the genus. See Ariad, 598 F.3d at 1350. The
Specification therefore fails to provide adequate written descriptive support
for the claim term MAACs. When there is substantial variation within the
genus, as there must be in this instance, Appellants are obliged to describe a
sufficient variety of species to reflect the variation within the genus. See
AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d
1285, 1300 (Fed. Cir. 2014) (holding that a patentee of a biotechnological
invention cannot necessarily claim a genus after only describing a limited
number of species because there maybe unpredictability in the results
obtained from species other than those specifically enumerated).
Furthermore, viewed as a primarily functional limitation, Appellants'
Specification fails to disclose the requisite correlation between structure and
function; indeed, Appellants do not attempt to argue that it does. Ariad, 598
F.3d at 1350. Finally, Appellants' Specification fails to disclose "structural
features common to the members of the genus." Id.
Because we therefore conclude that the limitation of claim 1 reciting:
"a therapeutically effective amount of a macromolecular anti-angiogenic
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component (MAAC), wherein the MAAC is a protein" fails to meet the
written description requirement of 35 U.S.C. § 112, first paragraph, we
uphold the Examiner's conclusion in this respect.
Issue 2
Appellants argue the Examiner erred in finding that the Specification
fails to provide adequate written descriptive support of the limitation of
claims 24-30 reciting "at least" a given viscosity. App. Br. 21.
Analysis
Claim 30 is representative of these claims and recites: "The method
of claim 1 wherein said viscosity[ -]inducing component has a viscosity of at
least 300,000 cps at a shear rate of 0.1/second at 25°C." App. Br. 26.
Appellants dispute the Examiner's finding that:
The phrase "at least" has no upper limit and thus the claims
encompass embodiments beyond the range of range of 10 cps to
300,000. The two compositions comprising sodium hyaluronate
to yield a particular viscosity is not deemed to be representative
of the genus of compositions encompassed by the claims.
Therefore, the [S]pecification does not provide written
description for the full scope of the claims.
App. Br. 21 ( quoting Final Act. 11 ). Appellants argue that their
Specification discloses that:
Advantageously, the present compositions have viscosities of at
least about 10 cps or at least about 100 cps or at least 10 about
1000 cps, more preferably at least about 10,000 cps and still more
preferably at least about 70,000 cps or more, for example up to
about 200,000 cps or about 250,000 cps.
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Id. at 21-22 ( quoting Spec. 42). Appellants contend that the Specification
thus discloses written support for viscosity of greater than 300,000 cps. Id.
at 22. Appellants contend that this is not a genus/species situation, because
viscosity ranges are not generic terms. Id.
The Examiner responds that the claims in question describe the genus
of agents by the function of increasing the viscosity of the composition to a
viscosity of at about 25°C of at least 10 cps, at least 1,000 cps; at least
20,000 cps; at least 70,000 cps; at least 200,000 cps; at least 150,000 cps;
and at least 300,000, respectively. Ans. 27. The Examiner finds that
Appellants' Specification discloses that the viscosity-inducing components
include, but are not limited to, hyaluronic acid (such as a polymeric
hyaluronic acid), carbomers, polyacrylic acid, cellulosic derivatives,
polycarbophil, polyvinylpyrrolidone, gelatin, dextrin, polysaccharides,
polyacrylamide, polyvinyl alcohol, polyvinyl acetate, derivatives thereof,
and mixtures and copolymers thereof. Id.
The Examiner therefore finds that the claims encompass any number
of agents, however, the Specification only discloses a single viscosity
inducing-component, sodium hyaluronate, having viscosities of 170,000 cps
and 200,000 cps, and provides no guidance regarding the structure of the
viscosity-inducing component that will yield the desired viscosities of the
compositions recited in the various claims. Ans. 27. The Examiner finds
that the claims identify the viscosity-inducing component solely by function
without providing a corresponding structure common to the members of the
genus that yields the function. Id. The Examiner therefore concludes that
the Specification fails to provide written description for the genus of agents
encompassed by the term "viscosity[-]inducing component." Id.
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We are not persuaded by the Examiner's reasoning. Appellants'
claim 1, from which the claims at issue depend, recites, in relevant part:
[A] viscosity inducing component in an amount effective to
increase the viscosity of the composition to a viscosity at about
25°C of at least 10 cps at a shear rate of about 0.1/second,
wherein said viscosity inducing component is injectable into the
vitreous of a mammalian eye without permanently diminishing
visual acuity.
Appellants' Specification discloses that: "The viscosity-inducing
component of the present compositions is present in an amount effective to
increase the viscosity of the composition, which is usually an aqueous
composition, preferably in fluid or gel form" and that: "Viscosity inducing
components have been proposed, known, and/or used in ophthalmic
compositions for treatment of the eye. Advantageously, the viscosity
inducing component is present in an amount in a range of about 0.5% to
about 20% (w/v) of the composition." Spec. 27. Appellants' Specification
further discloses that:
In one embodiment, the present compositions have a viscosity of
at least about 10 cps or at least about 100 cps, preferably at least
about 1,000 cps, more preferably at least about 10,000 cps and
still more preferably at least about 70,000 cps, for example, up
to about 250,000 cps, or about 300,000 cps, at a shear rate of
0.1/second at about 25°C.
Id. at 28. As examples, the Specification discloses:
Examples of useful viscosity inducing components include, but
are not limited to, hyaluronic acid (such as a polymeric
hyaluronic acid), carbomers, polyacrylic acid, cellulosic
derivatives, polycarbophil, polyvinylpyrrolidone, gelatin,
dextrin, polysaccharides, polyacrylamide, polyvinyl alcohol,
polyvinyl acetate, derivatives thereof and mixtures and
copolymers thereof. In a particularly preferred embodiment the
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composition comprises a hyaluronic acid component, such as a
polymeric hyaluronic acid component, including a cross-linked
polymeric hyaluronic acid.
Id. at 43-44. More specifically, the Specification discloses:
A more detailed embodiment within the scope of our invention
is a pharmaceutical composition for treating a posterior ocular
condition, the pharmaceutical composition consisting essentially
of a MAAC, polymeric hyaluronate, in which polymeric
hyaluronate the MAAC is soluble, sodium chloride, sodium
phosphate, and water. The pharmaceutical composition can have
a viscosity at a shear rate 0.1/second of between about 128,000
cps and about 225,000 cps.
Id. at 33.
Appellants Tables 1 and 4 disclose various embodiments of the
claimed composition, with sodium hyaluronate, 0.05% w/v, having
viscosities ranging between 20 and 500 cps. Spec. 82-83. Appellants'
Table 3 discloses embodiments containing 2.3% and 2.5% (w/v) sodium
hyaluronate, with viscosities of about 170,000 and 200,000 cps, respectively.
Id. at 86. Finally, Appellants' Table 5 discloses other embodiments of
Appellants' composition containing sodium hyaluronate at 2.0%, 2.5%, and
3.0% (w/v) with viscosities of 100,000, 180,000, and 300,000 cps,
respectively. Id. at 84.
Appellants' claims at issue recite a viscosity inducing agent
functionally, i.e., by the magnitude of the viscosity they induce in the
resultant composition. Appellants' Specification thus discloses numerous
embodiments using various concentrations of sodium hyaluronate as a
representative viscosity-inducing agent, with resultant viscosities ranging
between 20 and 300,000 cps, as recited in the claims. We consequently
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agree with Appellants that the claims have sufficient written descriptive
support in the Specification. However, this conclusion does not disturb our
conclusion supra, that claim 1 and its dependents lack written support for the
limitation reciting: "a therapeutically effective amount of a macromolecular
anti-angiogenic component (MAAC), wherein the MAAC is a protein." We
consequently affirm the Examiner's rejection of the claims.
DECISION
The Examiner's rejection of claims 1, 5, 15, and 20-32 as
unpatentable under 35 U.S.C. § 112, first paragraph is affirmed.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § l .136(a)(l )(iv).
AFFIRMED
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